cyrilzakka/clinical-trials huggingface dataset:
Percutaneous Externally-Assembled Laparoscopic Urologic Surgery

This will be a single-arm prospective internally-controlled study. Patients will undergo percutaneous externally-assembled laparoscopic surgery where one or more 3 mm instruments are added or substituted for conventional 5 or 10 mm trocars.

The investigators have previously published a study regarding the use of a new surgical paradigm (percutaneous externally assembled laparoscopy, or PEAL) in porcine and cadaveric models in order to allow laparoscopic surgery to take place with improved cosmesis and decreased pain while still allowing the use of larger instruments and maintaining instrument triangulation. The investigators now seek to study the use of these instruments in the human patients undergoing laparoscopic urologic surgery.

This will be a single-arm prospective internally-controlled study. Patients will undergo percutaneous externally-assembled laparoscopic urologic surgery where one or more 3 mm instruments are added or substituted for conventional 5 or 10 mm trocars. Multiple outcome measures (endpoints) will be measured including time to first opioid use, total inpatient opioid dosage, patient ranking of painfulness of each port site, duration of ileus, time to ambulation, length of hospital stay, presence of any intraoperative or postoperative complications, operating time, estimated blood loss, and other routine parameters collected in a prospective surgical study.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparoscopic urologic surgery

Exclusion Criteria:

* Patients unwilling to participate in the study
* Patients unfit for laparoscopic surgery
Single Radiolabeled Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-ETC-1002

This Phase 1 study will assess the mass balance recover of carbon-14 (14C) labelled ETC-1002 and the routes and rates of excretion of \[14C\]-ETC-1002


Eligibility Criteria:
Inclusion Criteria:

* Healthy Male Volunteers
* BMI 10-35 kg/m2

Exclusion Criteria:

* Hx of CV, renal, hepatic, chronic respiratory or GI disease
* Hx of drug or alcohol abuse
* smoking within 12 mos of screening
Brain Computer Interface（BCI） System for Stroke Rehabilitation

A BCI system for stroke subjects will be designed in an attempt to train the motor-related areas in their brains responsible for hand open/close function. A robot hand will be used and controlled by the system in real time based on EEG pattern for identification of motion intention for hand movements in the motor cortex. A randomized controlled trial study design will be adopted. All subjects will be assessed by clinical assessments including FMA and neuroimaging assessments using multimodal MR techniques before and after the training to evaluate training effectiveness.


Eligibility Criteria:
Inclusion Criteria:

1. Sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment;
2. Subcortical ischemic lesion within the territory of the middle cerebral artery;
3. Have moderate to severe motor disability at the paretic upper limb (assessed by Fugl-Meter Assessment (FMA), Modified Ashworth Score of fingers (MAS), and Action Research Arm Test(ARAT)).
4. Hemiparesis resulting from a single unilateral lesion of the brain with onset at least 6 months before data collection.

Exclusion Criteria:

1. Severe hand spasticity, open hand wound or hand deformity;
2. Visual field deficits;
3. Aphasia, neglect, and apraxia,
4. Participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.
5. History of alcohol, drug abuse or epilepsy,
6. Bilateral infracts,
7. Uncontrolled medical problems,
8. Serious cognitive deficits,
9. Other MRI contraindications
Randomized Trial of Vitamin A and Vitamin E Supplementation for Retinitis Pigmentosa

To determine whether supplements of vitamin A or vitamin E alone or in combination affect the course of retinitis pigmentosa.

Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide prevalence of about 1 in 4,000. Patients typically report night blindness in adolescence and lose vision in the midperipheral followed by far-peripheral visual field in adulthood due to progressive loss of both rod and cone function. Most patients have reductions in central vision by age 50 to 80 years. Modern-day electroretinograms (ERGs) make it possible to record retinal responses from most patients with remaining vision and thereby monitor objectively the course of their disease.

While the natural course of retinal degeneration in the common forms of RP was being studied, it was noted that a subgroup of patients aged 18 through 49 who were treating themselves with both vitamin A and vitamin E and other nutritional supplements exhibited less decline in ERG amplitude over a 2-year period. These preliminary findings, as well as the known roles of vitamins A and E in maintaining normal photoreceptor function and structure, prompted this randomized, controlled trial to determine whether these vitamins alone or in combination would halt or slow the progression of the common forms of RP.

This study was a randomized, controlled double-masked trial with 2 x 2 factorial design and duration of 4 to 6 years. Patients were assigned to one of four treatment groups:

15,000 IU/day vitamin A

15,000 IU/day vitamin A + 400 IU/day vitamin E

trace amounts of both vitamins A and E

400 IU/day of vitamin E

The main outcome measure was the 30-Hz cone ERG amplitude. In addition, visual field and visual acuity were measured annually.

Eligibility Criteria:
Men and nonpregnant women between ages 18 and 49 years with common forms of RP were included. All eligible patients had retinal arteriolar attenuation, elevated dark adaptation thresholds, and reduced ERGs. Patients had best corrected Snellen visual acuity of 20/100 or better, central visual field diameter on the Goldman perimeter with V4 e white test light of 8 degrees or greater, and ERG amplitude of 2.5 or greater in response to 0.5-Hz white light or of 0.12 ultraviolet light or greater in response to 30-Hz white flickering light in at least one eye. In addition, patients had normal fasting serum retinol and serum liver function profile and weight above the lower fifth percentile for age, sex, and height. All patients had a total estimated pre-trial intake of vitamins A and E from diet plus pills not greater than 11,500 IU/day and 40 IU/day, respectively.
Systemic Inflammation Response Index and C-Reactive Protein to Albumin Ratio in Acute Lymphoblastic Leukemia

the goal of this observational study is Assesment of systemic inflammatory index (SII) , system inflammation response index (SIRI) and CRP Albumin ratio(CAR) as biomarkers for ALL prognosis.

Acute lymphoblastic leukemia (ALL) results from a clonal expansion of abnormal, immature lymphoid progenitors of B cell or T cell origin that invade bone marrow (BM), peripheral blood, and extramedullary sites .

The incidence of ALL is highest among children aged 1-4 years and declines with age rising slightly after the age of 50. Several genetic alterations have been already found as drivers of ALL, uncovering the genetic heterogeneity of the disease.

It is the most common leukemia in the pediatric population, according for up to 80% of cases in this group vs. 20% of cases in adults. Treatment among adolscents and young adults is predominantly inspired by pediatric regimens with better survival rates .

Acute leukemia tends to present non-specifically, although the most common presenting features include fever, lethargy, and bleeding. Hepatosplenomegaly, lymphadenopathy, and musculoskeletal symptoms (especially involving the spine and long bones) can also be clues to the diagnosis. Adults may also have more prominent anemia-related symptoms, such as shortness of breath, or symptoms related to thrombocytopenia, such as excessive bruising or increased bleeding tendency.

Eligibility Criteria:
Inclusion Criteria:

Newly diagnosed ALL patients that admitted to the South Egypt Cancer Institute and not received any treatment.

Exclusion Criteria:

1. Presence of other hematological disorders( other than ALL)
2. History of other malignancies, or relapsed ALL.

2- Patients under chemotherapy or radiotherapy. 3- Signs of inflammation 5- Evidence of autoimmune disease.
Cocktail Sedation Containing Propofol Versus Conventional Sedation for Endoscopic Retrograde Cholangiopancreatography (ERCP)

Endoscopic retrograde cholangiopancreatography (ERCP) practically requires moderate to deep sedation by a combination of benzodiazepine and opioid. Propofol as a sole agent may cause oversedation. A combination (cocktail) of infused propofol, meperidine, and midazolam can reduce the dosage of propofol and may result in a lower risk of oversedation. The investigators prospectively compare the efficacy, recovery time, patient satisfactory, and side effects between cocktail and conventional sedations in patients undergoing ERCP.

ERCP patients were prospectively randomized into 2 groups; the cocktail group and the controls. For induction, a combination of 25 mg of meperidine and 2.5 mg of midazolam were injected in both groups. In the cocktail group, a bolus dose of propofol 1 mg/kg was administered and continuously infused. In the controls, 25 mg of meperidine or 2.5 mg/kg of midazolam were titrated to maintain the level of sedation.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for ERCP

Exclusion Criteria:

* Age under 18 years
* American Society of Anesthesiologists' (ASA) physical classification IV - V
* History of sulfite, egg or soy bean allergy
* Emergency need for ERCP
* Informed consent could not be obtained
Surfactant for Neonatal Respiratory Distress Syndrome at High Altitude Areas:a Prospective Cohort Study

The traditional concept believes that the etiology of neonatal respiratory distress syndrome (RDS) is immature development of lung,especially the surfactant synthesis system,and RDS is still one of the major causes of mortality and morbidity in newborns, especially premature infants.In recent years, using pulmonary surfactant replacement therapy (PS treatment) in the treatment of respiratory distress syndrome (RDS) is a major breakthrough in neonatal medicine.Combined with clinical practice and experience,and through Meta analysis of related randomized controlled trials (RCTs),it confirms that natural surfactant treatment can reduce mortality,the incidence of pulmonary air leaks (pneumothorax and interstitial lung emphysema),and the incidence of bronchopulmonary dysplasia (BPD) or 28-day-old mortality.For RDS in preterm infants whose gestation is \<35 weeks ,surfactant replacement therapy is also more effective than in nearly term and full term infants.Therefore, in the analysis of cases of different gestational age groups,the investigators should focus on the study of premature infants cases.Due to less relevant research for using PS treatment to cure newborn RDS in high altitude area,this retrospective study conducts statistics and analysis of recently three-year cases in some hospital of high altitude area,to explore the treatment effect of the high altitude region and the impact of altitude on the treatment.

in order to explore feasibility and efficacy for PS treatment of newborn RDS in high-altitude area ,and its efficacy at different altitudes, the investigators conduct a multi-center retrospective study of RDS cases in Qinghai and Tibet these two high-altitude area,and use RDS cases under the unique conditions to do statistics and analysis.

Eligibility Criteria:
Inclusion Criteria:

* the preterm infants less than 37 weeks were included in the study;diagnosed with NRDS

Exclusion Criteria:

* parents' rejecting to join;major congenital abnormalities
Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers.

Study to demonstrate the safety and effectiveness of a new oral enhanced airway device to treat simple snoring.

The Keepasleep airway device is a novel and unique buccopharyngeal airway device to enhance breathing during sleep. This method has not been described in the medical literature and has been successful in limited testing. This clinical trial is to determine the safety and effectiveness of the KEEPASLEEP device utilizing 30 subjects with simple snoring. Each subject will serve as his/her own control. The device augments airflow into the posterior pharynx to minimize airway collapse,tissue vibration, and consequent snoring.The device passes through the retromaxillary space and requires that the subject be absent their wisdom teeth.

Eligibility Criteria:
Inclusion Criteria:- 18 yrs. of age or greater

* generally good health
* Intact dentition / ABSENT upper and lower wisdom teeth ( by extraction or lack of development )
* Simple snoring( documented by observer) or mild sleep apnea RDI \< 15 ( documented by polysomnogram)
* Subject must have a concerned observer to assess of sleep and snoring behavior during trial period

Exclusion Criteria:- Presence of Wisdom teeth (third molars)

* active oral disease
* acute illness
* BMI (body mass index) \> 30
The Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease (P08637)

The purpose of this study is to confirm the safety and efficacy of diquafosol tetrasodium ophthalmic solution, 2% vs. placebo, in subjects with dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Have best corrected visual acuity in both eyes of at least +0.7 or better
* Central corneal staining of 3 on the NEI scale
* If female, are non-pregnant or non-lactating
* Have a history of dry eye disease in both eyes
* Have normal lid anatomy

Exclusion Criteria:

* Unable to withhold the use of contact lenses during the study or 2 weeks prior to the study
* Have had ocular surface surgery within the past year
* Are considered legally blind in one eye
* Have a serious medical condition which could confound study assessments
Nebulized Tranexamic Acid in Sinus Surgery

The results of several recent studies on endoscopic sinus surgery through topical administration of tranexamic acid are encouraging in terms of the efficacy of tranexamic acid for intraoperative bleeding and other pathological conditions.The purpose of this study is to analyze the efficacy of nebulized tranexamic acid to improve the surgeon and patient experiences of sinus surgery and know the effective and safe dose of nebulized tranexamic acid.

A written informed consent will be taken from the patients.The study involved adults of either sexes (age 18-65 years) of ASA I-II who will be listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia, with normal accepted coagulation profile and hematocrit value ≥30 %. Excluded from the study patients with chronic renal failure, liver cirrhosis, bleeding disorders, current anticoagulant therapy, pregnancy or breastfeeding, impaired color vision, severe vascular ischemia, history of venous thrombosis, pulmonary embolism, long term treatment with acetylsalicylic acid or non-steroidal anti-inflammatory drugs not discontinued before surgery, a hemoglobin (HB) concentration \<10 mg/dl or allergy to TXA.

Randomization: A random number sequence created by an internet website (http://www. random.org) will be used for patients' allocation. The random number sequence was retained in closed opaque envelopes released the day of the surgery by an independent physician not involved in the study. Patients will be assigned randomly to three groups (30 subjects each); saline placebo (Group S) and two different doses of preemptive nebulized tranexamic acid (Group T1) and (Group T2).To keep blinding, Group S will receive 2 sessions of nebulization each by 5 ml saline. Group T1 will receive one nebulization session 500 mg tranexamic acid (5 ml) and another one by 5 ml saline. Group T2 will receive 2 nebulization sessions each by 500 mg tranexamic acid (each by 5 ml)

Eligibility Criteria:
Inclusion Criteria:

* Either sexes (age 18-65 years) of ASA I-II who are listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia
* normal accepted coagulation profile and hematocrit value ≥30

Exclusion Criteria:

* chronic renal failure
* liver cirrhosis
* bleeding disorders
* current anticoagulant therapy
* pregnancy or breastfeeding
* impaired color vision
* severe vascular ischemia
* history of venous thrombosis, pulmonary embolism
* long term treatment with acetylsalicylic acid or non-steroidal anti-inflammatory drugs not discontinued before surgery
* hemoglobin (HB) concentration \<10 mg/dl _allergy to TXA.
Dexmedetomidine as Adjuvant in Erector Spinae Plane Block After Shoulder Arthroscopy

The aim of this study is to evaluate the effect of adding dexmedetomidine as an adjuvant to bupivacaine in ultrasound (US) guided erector spinae plane block (ESPB) for managing acute postoperative pain in patients undergoing shoulder arthroscopy.

Shoulder arthroscopy is a common procedure done is orthopedics for many surgical indications as rotator cuff tears, stiffness and instability. This procedure has a well - documented postoperative pain. To improve the outcome after surgery, effective pain control is needed.

There are many postoperative pain management modalities after shoulder arthroscopy including non-steroidal anti-inflammatory drugs, intraarticular injection, regional nerve blocks, patient controlled analgesia and cryotherapy.

The erector spinae plane block (ESPB) is one of the emerging regional techniques for managing postoperative pain. ESPB has been used successfully in many surgeries such as mastectomy, thoracotomies , percutaneous nephrolithotomies, lumbar fusions, hernia repair, cesarean delivery and even in total hip arthroplasty .

ESPB has been successfully used to treat chronic shoulder pain, and the local anesthetic spread was reported to reach the level of C3 when it was performed at T2.

Dexmedetomidine is a very selective α2 adrenoceptor agonist that is tenfold more selective than clonidine. It is a highly flexible medication in anesthetic practice, finding use in an expanding range of clinical circumstances.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65 years
* Both genders and BMI \< 40 kg/m2
* American Society of Anesthesiologists (ASA) physical status I-II
* Patients who are posted for elective shoulder arthroscopy

Exclusion Criteria:

* Known allergy to local anesthetics
* Allergy to all opioid medications
* Diagnostic shoulder arthroscopic procedures,
* Patients with chronic opioid use and coagulopathy
KOKON Consultation on Complementary Medicine in Oncology - a Pilot Study

The aim of the study is to investigate the effect of a consultation training program for physicians on the quality of their consultations of breast cancer patients regarding complementary medicine. We assume that the training program might enhance the communication of relevant information, empathy of the physicians or satisfaction with the consultation.


Eligibility Criteria:
Inclusion Criteria for physicians:

* age \>18 years
* working in a breast center of comprehensive cancer center
* able to consult 10 patients within working hours
* training group: able to participate in on-site-training
* not primarily treating the patients that are consulted
* good language skills (for consultations)
* informed consent

Inclusion Criteria for patients:

* age \> 18 years
* female
* diagnosis of breast-cancer
* patient in the participating center
* good language skills (for consultations)
* informed consent
A Study for Adult Patients With Fibromyalgia

The main purpose of this study is to determine if 30 milligrams (mg) of duloxetine is effective in the treatment of fibromyalgia compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Meet study criteria for fibromyalgia diagnosis.

Exclusion Criteria:

* Have previously or are currently taking duloxetine.
* Have been diagnosed with certain psychoses, bipolar or schizoaffective disorder
* Have pain symptoms that are difficult to differentiate from fibromyalgia.
* Have seizure disorder, uncontrolled narrow angle glaucoma, or acute liver injury (such as hepatitis) or severe cirrhosis.
* Have had any primary Axis 1 diagnosis other than major depressive disorder or generalized anxiety disorder within the past year.
* Are pregnant or breast-feeding
* Have a current or previous diagnosis of rheumatoid, infectious or inflammatory arthritis or an autoimmune disease
* Have a regional pain syndrome, failed back syndrome or chronic localized pan related to any past surgery
* Have a serious unstable medical illness
* Have a history of substance abuse or dependence within the past year
NVA237 BID Versus Placebo Twelve-week Efficacy Study

The study serves to determine whether the treatment of patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and safe. The efficacy and safety of the drug will be tested against a placebo treatment. The primary criterion to assess efficacy will be the difference between the serial lung function measurements of patients who have been treated for 12 weeks with NVA237 versus those that have received placebo treatment for 12 weeks. A serial lung function measurement (FEV1 testing) will be conducted and the "area under the curve" will be the measure for the ability to breathe.


Eligibility Criteria:
Inclusion criteria: 1. Patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with airflow obstruction of level 2 and 3 according to the current Global initiative for chronic Obstructive Lung Disease (GOLD) strategy (2011). 2. Patients with Forced Expiratory Volume in one second (FEV1) ≥ 30% and \<80 % of the predicted normal, and FEV1/FVC \< 0.70 when measured 45 min after the inhalation of 84 µg ipratropium bromide.

3. Current or ex-smokers with at least 10 cigarette pack years smoking history.

Exclusion criteria:

1. Patients with a history of long QT syndrome, with a prolonged QTc measured during screening, or patients who have a clinically significant ECG abnormality at screening.
2. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
3. Pregnant or nursing (lactating) women. Women of childbearing potential unless using an effective method of contraception.
4. Patients who in the judgment of the investigator, would be at potential risk if enrolled into the study.
5. Patients who have a clinically significant concomitant disease at screening, including but not limited to clinically significant laboratory abnormalities, clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities, or with uncontrolled diabetes, which could interfere with the assessment of the efficacy and safety of the study treatment.
6. Patients with a body mass index (BMI) of more than 40 kg/m2.
7. Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, long and short acting beta-2 agonists, or sympathomimetic amines.
8. Patients with any history of asthma, with onset of symptoms prior to age 40 years, or patients with a high blood eosinophil count during screening.

Other protocol-defnied inclusion/exclusion criteria may apply.