cyrilzakka/clinical-trials huggingface dataset:
Motexafin Gadolinium and Radiation Therapy in Treating Young Patients With Pontine Glioma

This phase II trial is studying how well giving motexafin gadolinium together with radiation therapy works in treating young patients with pontine glioma. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as motexafin gadolinium, may make tumor cells more sensitive to radiation therapy. Giving motexafin gadolinium together with radiation therapy may kill more tumor cells.

PRIMARY OBJECTIVES:

I. Evaluate the effect of combining motexafin gadolinium with daily fractionated radiotherapy on 1-year event-free survival of pediatric patients with intrinsic pontine glioma (brain stem glioma).

SECONDARY OBJECTIVES:

I. Evaluate the effect of combining motexafin gadolinium with daily fractionated radiotherapy on 1-year overall survival of these patients.

II. Determine the toxicities of motexafin gadolinium in combination with radiotherapy in these patients.

OUTLINE: This is a multicenter study.

Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo focal cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 3 years and then periodically thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of intrinsic pontine glioma (brain stem glioma)

  * Clinical and radiographic (MRI) evidence of tumors that diffusely involve the brain stem (i.e., tumors that intrinsically \[\> 50% intra-axial\] involve the pons or pons and medulla, pons and midbrain, or entire brain stem) allowed
  * Tumor may contiguously involve the thalamus or upper cervical cord
  * No more than 1 lesion/mass present at diagnosis
* Karnofsky performance status (PS) 60-100% (age \> 16 years) OR Lansky PS 60-100% (age ≤ 16 years)
* Life expectancy ≥ 8 weeks
* Absolute neutrophil count ≥ 1,000/mm³
* Platelet count ≥ 100,000/mm³ (transfusion independent)
* Hemoglobin ≥ 10 g/dL (RBC transfusions allowed)
* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine normal for age/gender (0.4-1.7 mg/dL)
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT \< 1.5 times ULN
* No known glucose-6-phosphate dehydrogenase (G6PD) deficiency

  * If family history suggestive of congenital hemolytic anemia, patient must be screened for G6PD with G6PD activity test prior to study entry
* No biliary obstruction
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior definitive therapy for this specific tumor
* No prior cranial radiotherapy
* Concurrent steroids and anticonvulsants allowed
* No concurrent proton therapy
* No concurrent intensity-modulated radiotherapy
* No concurrent anticancer chemotherapy
* No concurrent immunomodulating agents
Knowledge-based Dietary Weight Management.

This research is to develop a weight loss and weight maintenance program through dietary modifications for adults with obesity. Although scientific studies have shown the feasibility of rapid and safe dietary weight loss and subsequent weight maintenance, no efficacious dietary weight management program is widely available, and thus bariatric surgery remains the most reliable approach for weight loss/management. Safe and effective dietary weight loss and subsequent weight maintenance require flexible, individualized advice by an experienced dietitian/nutritionist.


Eligibility Criteria:
Inclusion criteria:

* age 18-64 years;
* body mass index (BMI) \>28 kg/m2;
* not currently pregnant or lactating;
* have Wi-Fi at home, a working email, and an iPhone or Android smartphone.
* no self-reported severe metabolic, cardiovascular or musculoskeletal disease;
* not using insulin injection;
* able to attend the 22 (1 hour) diet improvement sessions.
* willing to lose 20 lb. or more for 6 months and maintain a healthy weight for one year.
* keep weighing their weight for one and a half years.
* fluent in reading and writing English.

Exclusion criteria:

* age \<18 or \>64 years;
* body mass index of \<28 kg/m2;
* currently pregnant;
* currently lactating;
* self-reported with the severe metabolic, cardiovascular or musculoskeletal disease;
* use insulin injection;
* not able to attend the 22 (1 hour) diet improvement sessions for 1 year;
* failed to set up a Wi-Fi scale;
* failed to submit a food frequency questionnaire
Evaluation of Two Treatments for Chronic Post Concussion Syndrome

This study is designed to investigate factors that are associated with prolonged recovery from mild head injury. The investigators are particularly interested in defining the impact of anxiety related variables, such as health anxiety and anxiety sensitivity in the maintenance of symptoms.

A further goal of the study is the evaluation of two treatment methods that have been proposed to be effective in reducing the impact of post concussion symptoms. The investigators hypothesize that a treatment which is directly focused on changing these anxiety related variables will be more effective than one that does not.


Eligibility Criteria:
Inclusion Criteria:

* Mild Head Injury at least 3 months prior to treatment
* age 19 to 65 years
* grade 12 education
* proficiency with English language

Exclusion Criteria:

* Current Litigation
Effects of Controlled Ovarian Hyperstimulation (COH) With Letrozole and Gonadotropin

Fertility drugs have the effect of increasing hormone levels. Higher hormone levels from infertility treatments may increase breast cancer risk, but there has not been enough research to know for sure. Researchers want to use a method of taking breast tissue cells from women who are having infertility treatment. The breast tissue cells might show changes that would indicate an increased risk of cancer. The method of taking the breast tissue cells is called Fine Needle Aspiration (FNA).

The purpose of this study is to examine the changes in breast tissue, in women at high risk of breast cancer who are being treated with controlled ovarian hyperstimulation.


Eligibility Criteria:
Inclusion criteria:

1. Women must be at increased risk for breast cancer based on any of the following criteria:

   * Age 30 or older with no prior live birth.
   * Mutations associated with hereditary cancer (BRCA1 or 2, P53, PTEN)
   * Family history of breast cancer including one first degree or multiple second degree relatives
   * History of chest radiation before age 30
   * Multiple prior breast biopsies
   * Precancerous conditions (DCIS, LCIS, AH)
   * Prior history of breast or ovarian cancer
   * Estimated mammographic breast density \> 50%
2. Must be undergoing infertility treatment at the University of Kansas with Controlled Ovarian Hyper-stimulation (COH)
3. Must be between the ages of 21-45 (both inclusive) with Day 3 FSH less than 12 IU/L, Day 3 E2 less than 80 pg/ml

Exclusion criteria:

1. Women under 21 or over 45 years old
2. Day 3 FSH over 12 IU/L, Day 3 E2 over 80 pg/ml
3. Women who do not meet risk criteria above
4. History of hypersensitivity to letrozole or gonadotropin
5. Uterine and adnexal pathology
6. Use of clomid or gonadotropin within 30days before the letrozole cycle
7. Any severe chronic disease of relevance for reproductive function
The Influence of Vertebral Mobility on Low Back Pain in Patients With Acute Osteoporotic Vertebral Fractures

Many patients with acute osteoporotic vertebral fracture (acute OVFs) admitted because of low back pain. But there are only part of patients with acute OVFs, because some patients do not have low back pain although OVFs occurred.

Many patients of acute OVFs present with low back pain. While there are also many patients without low back pain even if acute OVFs occurred. The mechanism of low back pain after acute OVFs is well unknown. We set up a hypothesis that low back pain results from vertebral body mobility, which refers to a change of vertebral height or configuration with changes in body positioning. The main objective of this study is to reveal the relationship between vertebral body mobility and low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute osteoporosis fractures

Exclusion Criteria:

* Patients without acute osteoporosis fractures (metastasis, infection, deformity,etc)
Comparison of Effectiveness of Pre-cooling With Ethyl Chloride Versus Honey

Comparing Pre-cooling with Ethyl Chloride versus Honey in Alleviating Intra-oral injection pain in Adult patients


Eligibility Criteria:
Inclusion Criteria:

* No medical history
* Patients suffering from Symptomatic Irreversible Pulpitis requiring buccal infiltration

Exclusion Criteria:

* Patients having any medical conditions considered to affect patient safety or the quality of the study
* if they had any known hypersensitivity to local anaesthetics of amide type or any of the other contents in the substance used
Interferon Toxicities in Melanoma Treatment

The primary objective of this study is to quantify and compare the prevalence of adverse events (AEs) in patients with stage III melanoma before and after initiation of interferon (IFN) therapy in a real-world setting. A secondary objective is to quantify annual costs and resource utilization before and after IFN initiation among patients with stage III melanoma in a real-world setting.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a pharmacy claim for IFN between 1/1/2007 and 12/31/2011. The date of the first observed claim will be defined as the index date
* Patients with a melanoma diagnosis based on two medical claims prior to the index date
* Patients with a procedure code for melanoma-related lymph node dissection before the index date
* Patients ≥ 18 years of age on or before the index date
* Patients with continuous benefit enrollment for at least 180 days before and after the index date

Exclusion Criteria:

* Patients with diagnosis of any other (primary) cancer during the 180-day pre-index period (excepting skin cancers and hematologic malignancies)
* Patients with diagnosis of a secondary cancer during the 180-day pre-index period or on the index date (excepting lymph node metastasis to a site common for melanoma or an improbable site for any other primary cancer)
* Patients who received systemic chemotherapy during the pre- or post-index period
Intravenous Nalbuphine Versus Intravenous Dexmedetomidine for Conscious Sedation in Patients Undergoing Colonoscopy

The aim of this study is to compare the sedative, analgesic effect and hemodynamic changes due to dexmedetomidine and nalbuphine during elective colonoscopy.

Colonoscopy can be performed for the screening of cancer, adenomas, and polyps, for the assessment of known or possible bleeding, and for the evaluation of possible causes of abdominal pain, gastrointestinal symptoms, and/or changes in bowel habits. colonoscopy is associated with discomfort and sometimes pain. At present, the commonly used methods are the intravenous injection of propofol, etomidate, ketamine, and other drugs to make the patient's unconscious. The disadvantage is that the patient cannot cooperate during the examination (e.g., for changing position), and medical staff is needed to assist in turning over the patient, if necessary. This may compress the patient's stomach and abdomen, which may cause gastric reflux and aspiration, which may cause pneumonia, with morbidity and even mortality. Nalbuphine hydrochloride is a mixed agonist-antagonist opioid with a duration of action of approximately 3-6 hours. It is chemically related to both the agonist analgesic oxymorphone and the antagonist naloxone, and acts as an antagonist at the μ receptor and as an agonist at the κ receptor, resulting in analgesia and sedation with minimal effects in the cardiovascular system. Any slight RD that occurs would be restricted by a ceiling effect. Dexmedetomidine, a new drug, is highly selective α2-adrenergic receptor agonist. It possesses hypnotic, sedative, anxiolytic, sympatholytic, and analgesic properties without producing significant respiratory depression. It also reduces both anesthetic and opioid analgesic requirements during the perioperative period. It has an impressive safety margin,and it may be suitable for conscious sedation during painful procedures.

Eligibility Criteria:
Inclusion Criteria:

1. The subject is scheduled for elective colonoscopy.
2. The subject is ≥ 18 years and ≤ 80 years.
3. Both sexes.
4. No obvious abnormalities in preoperative ECG, blood routine ,electrolytes, and other tests .
5. ASA class 1-3.

Exclusion Criteria:

1. Subject is known or believed to be pregnant or lactating women.
2. Patients allergic to α2-adrenergic agonist or sulfa drugs
3. Chronic Opioid Use (daily or almost daily use of opioids for \> 3 months).
4. Patients that are immunologically compromised, or receiving chronic steroids (\>30 days), excluding inhalers.
5. Sleep apnea syndrome or difficult airway.
6. Patient known to be asthmatic or recent chest infection.
7. Patients that are prisoners.
8. Patient refusal.
A Clinical Study Evaluating the Efficacy and Tolerability of a Topical Facial Treatment For Facial Rejuvenation

This single-center clinical trial was conducted to evaluate the efficacy and tolerability of a topical facial treatment when applied by a license esthetician in clinic in a series of 3 sessions with 1 month intervals, in combination with a cleanser, moisturizer, and sunscreen over the course of 12 weeks in healthy women aged 35 to 60 with mild to moderate global facial fine lines, wrinkles, and laxity. Thirty-two (32) healthy female subjects completed the clinical study.

This single-center clinical trial was conducted to evaluate the efficacy and tolerability of a topical facial treatment when applied by a license esthetician in clinic in a series of 3 sessions with 1 month intervals, in combination with a cleanser, moisturizer, and sunscreen over the course of 12 weeks in healthy women aged 35 to 60 with mild to moderate global facial fine lines, wrinkles, and laxity.

The efficacy and tolerability of the topical facial treatment in improving mild to moderate global facial fine lines, wrinkles, and laxity. was evaluated by Investigator clinical efficacy grading and tolerability grading by a board-certified dermatologist, subject tolerability grading, and clinical photography.

Eligibility Criteria:
Inclusion Criteria:

* Having Fitzpatrick Skin Type I - VI
* Having mid to moderate global face fine lines, wrinkles, and laxtiy (tactile) (score of 3 to 6 according to a modified Griffiths scale).

Exclusion Criteria:

* Breastfeeding, pregnant, or planning to become pregnant during the study.
* Currently having or having a history of cold sores (Herpes simplex) on the face.
A Study of EndoChoice's Upper&Lower Endoscopic Systems Utilizing a Full Spectrum Optical Technology

EndoChoice's FUSE System enables a wider view range via 1-2 additional cameras (depending on the model). These optical properties are to be examined and reviewed in this trial (mainly usability and safety)

EndoChoice Full Spectrum Optical Technology (FSOT) in gastrointestinal endoscopy enables a 330 degree field of view. FSOT powers EndoChoice's FDA, CE and AMAR (Israeli medical device authority) approved Endoscopic systems (Gastroscope and Colonoscope). The intent of this study is to evaluate the safety, performance and usability of additional versions of FSOT- powered gastroscopes and colonoscopes.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female patients ages of 18-70
* The patient has been scheduled for routine screening upper or lower endoscopy, diagnostic endoscopic work up, or endoscopic surveillance.
* Signed informed consent

Exclusion Criteria:

* Patients with inflammatory bowel disease;
* Patients with a personal history of polyposis syndrome;
* Patients with suspected bowel stricture potentially precluding complete endoscopy
* Patients with a history of diverticulitis or toxic megacolon
* Patients with a history of radiation therapy to neck, abdomen, pelvis;
* Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
* Patients with GI bleeding, that has not been corrected prior to endoscopy
A Clinical Trial of Patients With Solid Tumours Receiving Granulocyte Colony Stimulating Factor as Primary Prophylaxis for Chemotherapy-induced Neutropenia, in a Docetaxel Based Regimen

Primary Objective:

To evaluate the incidence and severity of neutropenia in patients being treated for solid tumours with a Taxotere® based regimen when Granocyte® 34 is being used as a primary prophylaxis for chemotherapy-induced neutropenia.

Secondary Objectives:

Haematological : To evaluate the incidence and severity of febrile neutropenia (with or without antibiotics) and anaemia in patients being treated for solid tumors treated with a Taxotere based regimen when Granocyte is being used as a primary prophylaxis.

Non-Haematological : To evaluate the incidence and severity of the following adverse events: asthenia, anorexia, myalgia, nail changes and oral mucositis in patients with solid tumours treated with a Taxotere based regimen; when Granocyte is being used as a primary prophylaxis.


Eligibility Criteria:
Inclusion criteria:

* Patients willing to sign informed consent prior to entry into the study,
* Patients who have been prescribed a Taxotere based regimen,
* Patients who have not yet started with the first Taxotere treatment,
* Patients with a histological diagnosis of one of the following solid tumours: breast cancer, non-small cell lung cancer (NSCLC), ovarian cancer, prostate cancer, gastric cancer or head and neck cancer.

Exclusion criteria:

* Patients who are enrolled in another clinical study,
* Pregnant and/or breastfeeding patients, including women of childbearing potential not willing to use medically acceptable methods of contraception,
* Patients with severe liver impairment,
* Patients with severe renal function impairment,
* Patients with a known hypersensitivity to Granocyte 34 or its constituents,
* Patients with a history of severe hypersensitivity reactions to Taxotere or Polysorbate 80,
* Patients with a baseline neutrophil count of \< 1500cells/mm3,
* Patients on other drugs that are contra-indications for the use with Taxotere,
* Patients on con-current radiotherapy.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma

The purpose of the study is to test safety and efficacy of different doses of thymosin alpha 1 (1.6 mg, 3.2 mg, and 6.4 mg) in combination with dacarbazine and with or without Interferon alpha in treating patients affected by stage IV melanoma.

Primary end-point is Tumor Response evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST). Secondary end-points are Overall Survival and Progression Free Survival.

Ninety-five patients are allocated to each arm to test the hypothesis that P0 \<= 0.05 vs the alternative hypothesis that P1 \>= 0.15 (alpha = 5%, within-group statistical analysis beta = 95%).


Eligibility Criteria:
Inclusion Criteria:

* Have read and signed the informed consent form
* 18 years \<=Age\<= 75 years
* Adequate contraception practice (fertile female patient)
* Confirmed diagnosis of metastatic melanoma (stage IV) with unresectable metastases and \>= 1 measurable lesion
* Adequate renal function as demonstrated by serum creatinine level \< 1.5 mg/deciliter (dl)
* Absolute Neutrophil Count (ANC) \>= 1.5 x 10000000000/L ; platelets \>= 100 x 10000000000/Liter (L)
* Good performance status: PS \<= 1 (ZUBROD-ECOG-WHO scale)
* At least 12 week life expectancy

Exclusion Criteria:

* Clinical diagnosis of autoimmune disease
* Transplant recipient
* Pregnancy documented by a urine pregnancy test or lactation
* Previous treatment with thymosin alpha 1
* Previous treatment with chemotherapy
* Presence of Central Nervous System (CNS) metastases
* Concomitant or prior history of malignancy other than melanoma
* Participation in another investigational trial within 30 days of study entry
* Active infectious process that is not of self-limiting nature
Laparoscopic Cholecystectomy in Children. Risk Factors for Conversion. A Prospective Study .

Cholecystectomy is the most common procedure in biliary surgery which may be open or laparoscopic.laparoscopic cholecystectomy is widely accepted as the gold standard technique in both adults and children .over recent years there has been a significant increase in paediatric cholecystectomies alongside a rising incidence of childhood gall stones.

The majority of paediatric gallstones are related to haemolytic diseases such as hereditary spherocytosis. In recent decades, the incidence of gallstone disease in children has risen which may be related to the epidemic of paediatric obesity and improved survival of critically ill neonates who have received long-term total parenteral nutrition or correction of abnormalities resulting in increased incidence of cholelithiasis in the paediatric population such as short gut syndrome.The rate of conversion to open cholecystectomy ranges between 2% and 20%. Certain preoperative and operative factors can reliably predict the chances of conversion to the open procedure. Until recently large studies are lacking of assessment of the risk factors that my be responsible for conversion of laparoscopic cholecystectomy to open cholecystectomy . This study aims to assess preoperative and operative risk factors for conversion to open surgery .

Eligibility Criteria:
Inclusion Criteria:

1. Patients with age less than 18 years old presented to assiut university hospitals at pediatric surgeey unit.
2. fit for surgery

Exclusion Criteria:

1. patients with co-existent common bile duct stones based on imaging and biochemical criteria.
2. Patients with Pancreatitis .
3. Patients with previous upper abdominal surgery.

5_Significant medical disease rendering patient unfit for Laparoscopic surgery (e.g. Chronic Pulmonary Disease, significant Cardiac Disease)
Comparison of the Pentax AWS® With the Macintosh Laryngoscopic Intubation in Obstructive Sleep Apnea Syndrome Patients

The Pentax-AWS_ system (AWS; Pentax Corporation, Tokyo, Japan) is a new rigid indirect laryngoscope which has an integrated tube passage function. Pentax-AWS improved the laryngeal view and facilitated tracheal intubation in patients with restricted neck motion. The purpose of this clinical trial was to evaluate the relative efficacy of the AWS laryngoscopes when used by experienced anesthetists in Obstructive Sleep Apnea Syndrome (OSAS) patients and to compare its performance with the Macintosh laryngoscope.

The occurrence of difficult intubation in OSAS patients is higher than in age and sex matched control patients. The Pentax-AWS_ system (AWS; Pentax Corporation, Tokyo, Japan) is a new rigid indirect laryngoscope which has an integrated tube passage function. Several studies reported that Pentax-AWS improved the laryngeal view and guide also facilitated rapid, easy and reliable tracheal intubation in patients undergoing elective surgery. The purpose of this clinical trial was to evaluate the relative efficacy of the AWS laryngoscopes when used by experienced anesthetists in OSAS patients and to compare its performance with the Macintosh laryngoscope. The investigators hypothesized that, in comparison with the Macintosh, AWS would reduce intubation difficulty, as measured by the intubation difficulty scale (IDS) score.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1-3 patients,
* aged 20years or older,
* undergoing uvulopalatopharyngoplasty(UPPP) surgery under general anesthesia for a polysomnography-confirmed diagnosis of OSAS.

Exclusion Criteria:

* unstable teeth or mouth opening of \< 18mm
* Patients with any pathology of the neck,
* upper respiratory tract or upper alimentary tracts,
* risk of pulmonary aspiration of gastric contents,
* a history of relevant drug allergy.