cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Chemotherapy-Induced Neuropathy

This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain in subjects experiencing pain due to chemotherapy-induced neuropathic pain in patients with cancer.

To determine the safety and efficacy of Cesamet™ in the symptomatic treatment of chemotherapy-induced neuropathic pain.

This is a phase IV, multicenter, open label of Cesamet™ at 1 mg daily progressing to 2mg BID in subjects with chemotherapy-induced neuropathic pain. This study has two phases: A pretreatment phase and a treatment phase.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with chemotherapy-induced neuropathic pain.
* Chronic daily pain present for at least 2 months.
* On stable analgesic regimen for one month.
* Baseline pain score greater than 40mm on a VAS.

Exclusion Criteria:

* Hypersensitivity to compounds in study drug or similar drugs
* Pregnant or lactating females
* Drug or alcohol abuse
* Unstable medical condition
Efficacy and Safety of Painless 5-aminolevulinic Acid Photodynamic Therapy for Moderate and Severe Acne Vulgaris

This study is being done to compare a new, continuous illumination and short Incubation time regimen of 5-aminolevulinic acid photodynamic therapy (painless ALA- PDT) to low-dose and conventional dose of oral isotretinoin for treatment of moderate or severe acne vulgaris. The hypothesis is that the painless ALA- PDT will be equally or more efficacious as oral isotretinoin, and taking effect more quickly with less adverse effect.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosed with moderate to severe acne
* Male and female patients of age between 18-40 years old
* All patients read the instructions of the subject, willing to follow the program requirements
* No other topical treatment received within 2 weeks prior to enrollment
* No systemic treatment was given within 4 weeks prior to enrollment
* Patients were unsuitable for other treatments for various reasons and signed informed consent when they had informed other alternatives and agreed to take pictures of the lesion

Exclusion Criteria:

* Those who did not complete the informed consent
* The lesions belongs to any of the following conditions: There is damage and inflammation, which may lead to the drug entering the open wound
* Patients with skin photoallergic diseases, porphyria
* Known to have a history of allergies to test drugs (porphyrins) and their chemically similar drugs
* Patients with other obvious diseases that may affect the evaluation of efficacy
* Scars or patients with a tendency to form scars
* Known to have severe immune dysfunction, or long-term use of glucocorticoids and immunosuppressants
* Severe heart, liver, kidney disease; with hereditary or acquired coagulopathy
* Those with severe neurological, psychiatric or endocrine diseases
* Women who are pregnant, breast-feeding or using inappropriate contraceptives -Those with a history of drug abuse; those who have participated in other drug clinical trials within 4 weeks before treatment
Oxytocin Effects on Food Motivation Pathways

Oxytocin is a peptide hormone produced in the brain that regulates food intake. However, the mechanisms for this effect in humans is not yet clear.

In this study, the investigators will therefore examine the effect of a single dose of intranasal oxytocin (compared to placebo) on levels of appetite-regulating hormones and functional magnetic resonance imaging activation of areas of the brain involved in food motivation.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-45 years old
* BMI 25-40
* Regular breakfast eater (at least 4 times per week)
* Stable weight within the past three months

Exclusion Criteria:

* Psychiatric disease, use of psychotropic medications
* History of eating disorder
* History of excessive exercise within the last three months (having run more that 25 miles in any one week or having exercised more than ten hours in any one week)
* History of diabetes mellitus
* Active substance abuse
* Hematocrit lower than the normal range
* Gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection)
* History of cardiovascular disease (such as hypertrophic cardiomyopathy, valvular heart disease, coronary heart disease, or coronary artery spasms)
* Untreated thyroid disease
* Tobacco use
* Cardiac pacemaker, surgical aneurysm clips, neurostimulator, implanted pumps, metal fragments in body/eyes, nitroglycerin patch, severe claustrophobia
Effects of Omega-3 Plus Low-dose Aspirin as Adjunct to Periodontal Debridement for Chronic Periodontitis in Diabetics

Therefore, the aim of this study is to investigate the effectiveness of daily supplementation of omega-3 polyunsaturated fatty acids and low-dose aspirin as adjunct therapy to one-stage full-mouth periodontal ultrasonic debridement for the treatment of chronic periodontitis in type 2 diabetic patients through a superiority randomized clinical trial.

Diabetes mellitus (DM) has become a global epidemic. Its complications can have a significant impact on quality of life, longevity, and costs in public health. The World Health Organization (WHO) estimates that by 2040, 642 million people will suffer from diabetes, around 10% of the world adult population (WHO, 2015). Periodontal Diseases are considered the sixth complication of DM. This close relationship between both diseases is characterized by mutual influence. Thus, an appropriate control of periodontal disease may facilitate the DM control, improving quality of life on diabetic patients. Besides that, the presence of DM might impair prognosis of diverse dental treatments due to its inflammatory nature, negative influence on wound healing, on bone biology, and the establishment of infections. As a host modulatory therapy (HMT), the daily supplementation of omega-3 polyunsaturated fatty acids and low-dose aspirin has been proposed as adjunct therapy to the treatment of chronic periodontitis, showing good clinical and metabolic results in normoglycemic patients. Therefore, the aim of this study is to investigate the effectiveness of daily supplementation of omega-3 polyunsaturated fatty acids and low-dose aspirin as adjunct therapy to one-stage full-mouth periodontal ultrasonic debridement for the treatment of chronic periodontitis in type 2 diabetic patients through a superiority randomized clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* a) Age ≥35 b) diagnosis of type 2 DM for ≥5 years c) DM treatment with oral hypoglycemic agents or insulin supplementation and diet d) glycated hemoglobin (HbA1c) levels from 6.5% to 11% e) at least 15 teeth (excluding third molars and teeth indicated for extraction) f) moderate to severe generalized chronic periodontitis (Armitage, 1999) g) agree and sign the formal consent to participate in the study after receiving an explanation of risks and benefits from an individual who is not a member of the study (Resolution number 196 - October, 1996, and Ethics and Code of Professional Conduct in Dentistry - CFO179/93).

Exclusion Criteria:

* a) medical conditions that required prophylactic antimicrobial coverage b) scaling and root planing in the previous 6 months c) antimicrobial therapies in the previous 6 months d) anti-inflammatory therapies in the previous 6 months e) systemic conditions, other than DM, that could affect the progression of chronic periodontitis f) current use of medication that could interfere with periodontal response to treatment g) pregnancy or lactation h) smoking
Chemotherapy Plus Immunotherapy Combined With SBRT as Neoadjuvant Therapy for Patients With Resectable NSCLC

In this study, patients with EGFR/ALK wild-type, resectable locally advanced NSCLC are expected to receive 1 cycle of chemoimmunotherapy as neoadjuvant therapy, followed by SBRT to the primary lung lesion, and chemoimmunotherapy for 2 cycles. Surgical treatment will be given within 4-6 weeks after the last cycle of chemoimmunotherapy, then immunotherapy maintenance for 1 year.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or pathologically confirmed, newly diagnosed non-small cell lung cancer patients;
2. Age ≥18 years;
3. (Eastern Cooperative Oncology Group, ECOG) (Performance Status, PS) score 0-1;
4. According to the 8th-9th edition of (American Joint Committee on Cancer, AJCC) (stage II-IIIA, for stage IIIB included T3-4N2, T4 only included tumor \> 7cm);
5. Puncture or biopsy samples were tested EGFR/ALK negative;
6. Surgically or potentially resectable after discussion by multidisciplinary team (MDT);
7. Who has not received systemic antitumor therapy and has not received chest radiotherapy;
8. Evaluable lesions in the lung or mediastinum;
9. The organ function level should meet the following criteria one week before enrollment: 1) Bone marrow function: hemoglobin ≥80g/L, white blood cell count ≥4.0\*10\^9/L or neutrophil count ≥1.5\*10\^9/L, platelet count ≥100\*10\^9/L; 2) Liver: total serum bilirubin level ≤1.5 times the normal upper limit, when serum total bilirubin level \> 1.5 times the normal upper limit, direct bilirubin level ≤ normal upper limit, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the normal upper limit; 3) Kidney: blood creatinine level \< 1.5 times the normal upper limit or creatinine clearance ≥50ml/min, urea nitrogen ≤200mg/L; Serum albumin ≥30g/L;
10. Male/female of childbearing age agrees to use contraception during the trial period (surgical ligation or oral contraceptives/IUDs + condom contraception);
11. Sign informed consent.

Exclusion Criteria:

1. Patients with severe dysfunctions of the heart, lungs and other organs who are not suitable for surgery;
2. Patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granuloma), etc;
3. Other malignancies within 5 years (excluding non-melanoma skin cancer and cervical cancer);
4. Patient with active infection, heart failure, heart attack, unstable angina pectoris or unstable arrhythmia within the last 6 months;
5. Congenital or acquired immunodeficiency disorders include human immunodeficiency virus (HIV) or a history of organ transplantation or allogeneic stem cell transplantation;
6. Patients treated with other immunological agents, chemotherapy agents, other drugs in clinical trials and long-term cortisol therapy were excluded;
7. Patients who are allergic or contraindicated to PD-1 inhibitors.
Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant

Previous studies provide a rationale for administration of AZA after allo SCT for decreasing chimerism. The investigators hypothesize that azacitidine can be well tolerated after SCT and help decrease rate of decreasing donor chimerism and hence decrease relapse without increasing GVHD


Eligibility Criteria:
Inclusion Criteria:

1. Patients with AML/MDS/MPN, CMML post Allogeneic SCT who experience any drop in total or myeloid chimerism any time after day 30, or their day 30 or day100 myeloid donor chimerism is below 98% without concurrent hematologic relapse (that is, patients with \<5% bone marrow blasts as obtained at that time point) will be offered treatment with azacitidine
2. \>=30 -180 days post SCT and patients must have ANC\> 1000, PLT \> 50,000
3. Age 18-75 years old
4. Performance score of at least 70% by Karnofsky
5. Adequate kidney and liver function as demonstrated by:

   1. Creatinine clearance should be \>60 ml/min
   2. Total Bilirubin \<1.5, ALT/AST/Alk Phos \< 2.5 x normal. No evidence of chronic active hepatitis or cirrhosis.
6. Negative Beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study.
7. Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.
8. Patients must be off any prior chemotherapy, radiotherapy, or other investigational therapy within 2 weeks prior to start treatment

Exclusion Criteria:

1. Positive for HIV, HBsAg, HCV or other viral hepatitis or cirrhosis from any cause
2. Active or prior CNS leukemia, unless in complete remission for at least 2 months.
3. History of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs.
4. Uncontrolled infection
5. Grade III, IV graft versus host disease (GVHD
Study to Evaluate the Effect of Age (Geriatric) and Kidney Function on the Safety, Efficacy and Pharmacokinetics of OctreoScan in Patients Who Have New or Recurrent Tumors

The objective of this study was to evaluate the effect of age (geriatric) and renal function on the safety, efficacy and pharmacokinetics of OctreoScan at the recommended clinical dose in this patient population.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females 18 years of age and older.
2. If female and of childbearing potential, patients must have a negative pregnancy test within 24 hours of study drug administration. In addition, all female patients of childbearing potential must agree to use a medically accepted method of contraception throughout the study.
3. If deemed necessary by the Principal Investigator, patients entering the pharmacokinetic population must be willing to be housed within the investigational facility for a minimum of 24 hours following drug administration.
4. Patients (when able) or legally authorized representatives must have the ability to understand the requirements of the study and provide written consent to participate and agree to abide by the study requirements.
5. Patients must have tumor localization by conventional imaging methods prior to enrollment (i.e., CT, MRI, US, angiogram).
6. Patients referred for scintigraphy of solid tumors with a high suspicion of containing somatostatin receptor positive tissue.
7. Patients with first-time tumors must be scheduled for a tissue biopsy. A tissue sample will be sent to the core laboratory for conventional histology and immunohistochemistry analysis.
8. Patients with recurrent tumors or progressive tumors must have previous biopsy results documented, with previous biopsy tissue obtainable for immunohistochemistry analysis.

Exclusion Criteria:

1. Patients receiving Sandostatin LAR \< 21 days prior to dosing or Sandostatin Immediate Release (IM) \< 24 hours prior to dosing.
2. Patients who have received any investigational drug within 30 days of admission into this study or plan to participate in a clinical study prior to the end of this study's monitoring period (patients on a research protocol using an approved drug are accepted).
3. Patients who are pregnant, breastfeeding or lactating.
4. Patients with a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
5. Patients scheduled to undergo any scintigraphy within 7 days prior to study participation or PET scanning within 24 hours prior to study participation.
Pre-operative Neoadjuvant Therapy Combined With Surgery for Treating Stage III Hepatocellular Carcinoma

The purpose of present study is to evaluate whether per-operative neoadjuvant therapy combined with surgery could improve the 1-year disease-free survival of stage III hepatocellular carcinoma patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years old, both gender
* Confirmed diagnosis of stage III hepatocellular carcinoma(HCC)
* Fulfill the criteria of surgery
* No other severe comorbidity
* Eastern Cooperative Oncology Group score(ECOG) 0-2
* Expected survival \> 3months
* Informed consent obtained.

Exclusion Criteria:

* Received chemoradiotherapy or other antineoplastic drugs
* Severe cirrhosis with Child-Pugh score \>10
* Total bilirubin \> 1.5 times upper limit, AST or ALT \> 2times upper limit, indocyanine green retention rate after 15 min(ICG15) \>=40%;
* Not fulfill the surgery criteria
* Received major surgery within 1month
* History of other tumor
* Participate other clinical trial within 1month
* Drug or alcohol abuse, AIDS
* Uncontrollable epileptic seizure or cognitive disorder
* Severe allergy
* Other unsuitable conditions.
Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients

OBJECTIVES: I. Determine the prevalence of nontuberculous mycobacteria in sputum cultures from patients with cystic fibrosis.

II. Compare the clinical course of patients with negative versus positive cultures.

PROTOCOL OUTLINE: Participants are screened for nontuberculous mycobacteria (NTM) with 3 sputum acid-fast bacilli smears and mycobacterial cultures, with speciation of positive cultures, collected over 1 year. Demographic data, diagnostic criteria, clinical measurements, and other respiratory pathogen data are collected using the Cystic Fibrosis Foundation Patient Registry Questionnaire.

NTM-positive patients (cases) matched with NTM-negative controls identified in screening are followed every 3 months for 15 months. Cases are evaluated for NTM burden during the first 3 months.

Appropriate therapy is offered to consistently NTM-positive cases. Lung transplant recipients are removed from study.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

Patients over age 10 with cystic fibrosis documented as follows:

* Pilocarpine sweat chloride test at least 60 mEq/L OR
* Genotyping or transepithelial potential difference AND
* Clinical symptoms of suppurative respiratory disease or pancreatic insufficiency

Able to produce at least 3 sputum samples

* Bronchoscopy specimens acceptable
* Throat/nasal specimens not acceptable

No Pseudomonas cepacia colonization
Pro-adrenomedullin as a Prognostic Marker in Neonatal Sepsis

The aim of this study was to clarify the prognostic value of serum pro-Adrenomedullin level in neonatal sepsis. Eighty term and preterm neonates with sepsis were enrolled in this study. Eighty healthy matched neonates served as a control group.


Eligibility Criteria:
Inclusion Criteria:

* Clinical sepsis and/or proven sepsis.

Exclusion Criteria:

* Acute kidney injury
* Intracranial hemorrhage (Grade III and IV)
Topical Application of Imiquimod Gel at Different Concentrations in Actinic Cheilitis

Actinic cheilitis is a potentially malignant lesion on the lower lip, which can progress to more serious illnesses such as cancer if not treated. Usually treatment of this condition is only based on clinical appearance, but there is no established cure treatment. Topical imiquimod is a medicine indicated for the treatment of skin diseases, but it has not yet been proven to treat actinic cheilitis. In this research, the investigator's aim is to evaluate the response to actinic cheilitis treatment with the current standard treatment compared to high and low concentration imiquimod topical formulations.

Three formulations are used in this research: imiquimod 5%, imiquimod 0.05% e imiquimod nanoencapsulated 0.05%. Nanoencapsulation is a process that concentrates the drug into a capsule not visible to the naked eye, allowing it to penetrate skin more easily and will only release the drug at the lesion site. The drug is presented in a free form inside the gel in the others formulations.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with clinical and histopathological diagnosis of actinic cheilitis;
* No previous lip treatment with Imiquimod.

Exclusion Criteria:

* Present lesions suspected of squamous cell carcinoma of the lip.
* Previous history of lip cancer treatment.
* Prior treatment other than standard treatment.
* History of allergic reactions to imiquimod or any other component of the formulas.
Cerebral Oximetry in Newborns - Comparing INVOS 5100c and OxyPrem vs. 1.2

Regional tissue oxygenation (cStO2) can be monitored by near infrared spectroscopy. The commercial device INVOS 5100 (COVIDIEN, Mansfield, MA, USA) and the prototype OxyPrem vs. 1.2 (Biomedical Optics Research Laboratory, Zurich, Switzerland) will be used simultaneously to test for their relative sensitivity for low oxygen levels just after birth on term infants born by elective caesarean section. Reproducibility will be examined by replacements of the sensors six times the next day when the infant is stable and quiet. The Adult Somasensor (INVOS) will be used together with the OxyPrem sensor.


Eligibility Criteria:
Inclusion Criteria:

* Term infants
* Elective caesarean section

Exclusion Criteria:

* Thick hair that makes good measurements difficult/impossible
* obvious malformations or syndromes
* Complications in relation to caesarean section
* Depression after birth (APGAR \< 8 after 1 minute)
Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST)

This study will evaluate the efficacy, safety, tolerability of imatinib in the neoadjuvant treatment (pre-operatory) of patients with GIST. It will also evaluate the potential of imatinib to convert a tumor from inoperable to operable.


Eligibility Criteria:
Inclusion Criteria:

* patients with age between 18 and 80 years
* diagnosis of GIST not previously treated
* Patients will be included in the protocol regardless of operability; in the case of an operable tumor, patients are eligible if, in the opinion of the surgeon, resection would be suboptimal, disfiguring or functionally disabling (i.e. incomplete resection or other which cold compromise severely the quality of life or other GI function)

Exclusion criteria:

* presence of metastatic disease
* use of other antineoplastic treatment (chemotherapy, immunotherapy, radiotherapy)

Other protocol-defined inclusion/exclusion criteria may apply.
Midline Failures: A Comparison Between a Hydrophilic Biomaterial and Thermoplastic Polyurethane

Retrospective chart review to evaluate and compare the rate of failures between midlines made from different materials


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have been inserted with the HydroMID by the vascular access group
* Subjects who have been inserted with a competitor 4 Fr single lumen by the vascular access team

Exclusion Criteria:

* Any off-label use (PICC lines cut to be midlines for any manufacturer)