cyrilzakka/clinical-trials huggingface dataset:
Rectal Indomethacin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients

Pancreatitis (inflammation of the pancreas) is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP), a procedure for the diagnosis and treatment of disorders of the pancreas and bile duct.

Preliminary data has shown that non-steroidal antiinflammatory drugs, when administered rectally, can reduce the risk of pancreatitis after ERCP. This study is intended to definitively determine whether rectally administered indomethacin (a non-steroidal antiinflammatory drug)is effective at preventing pancreatitis after ERCP.

This study is a multi-center, randomized, placebo-controlled, double-blinded clinical trial of rectal indomethacin in the prevention of post-ERCP pancreatitis in high risk patients.

Eligibility Criteria:
Inclusion Criteria:

Included patients are those undergoing ERCP and have one of the following:

1. Clinical suspicion of sphincter of Oddi dysfunction
2. History of post-ERCP pancreatitis (at least one episode)
3. Pancreatic sphincterotomy
4. Pre-cut (access) sphincterotomy
5. \> 8 cannulation attempts
6. Pneumatic dilation of intact biliary sphincter
7. Ampullectomy

or at least 2 of the following:

1. Age \< 50 years old \& female gender
2. History of recurrent pancreatitis (at least 2 episodes)
3. ≥3 pancreatic injections, with at least one injection to tail
4. Pancreatic acinarization
5. Pancreatic brush cytology

Exclusion Criteria:

1. Unwillingness or inability to consent for the study
2. Age \< 18 years
3. Intrauterine pregnancy
4. Breast feeding mother
5. Standard contraindications to ERCP
6. Allergy to Aspirin or NSAIDs
7. Renal failure (Cr \> 1.4)
8. Active or recent (within 4 weeks) gastrointestinal hemorrhage
9. Acute pancreatitis (lipase peak) within 72 hours
10. Known chronic calcific pancreatitis
11. Pancreatic head malignancy
12. Procedure performed on major papilla/ventral panc duct in pt with pancreas divisum (no manipulation of minor papilla)
13. ERCP for biliary stent removal or exchange without anticipated pancreatogram
14. Subjects with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram
15. Anticipated inability to follow protocol
16. Endoscopist discretion: low risk (\<10%) of post-ERCP pancreatitis
A Phase I/II Clinical Study of SHR-1681 for Injection in Patients With Advanced Solid Tumors

This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-1681 for injection in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
2. Subjects with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;
3. Have at least one measurable tumor lesion per RECIST v1.1;
4. ECOG performance score of 0-1;
5. Life expectancy ≥ 3 months;
6. Adequate bone marrow and organ function.

Exclusion Criteria:

1. Subjects with active central nervous system metastases or meningeal metastases;
2. History of serious cardiovascular and cerebrovascular diseases;
3. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis;
4. Severe infection within 4 weeks prior to the first dose;
5. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.
Single Ascending Dose Safety Study of BMS-962476 in Healthy Subjects and Patients With Elevated Cholesterol on Statins

To obtain safety and tolerability information in healthy subjects is administered as a single dose

* Study Classification: Pharmacokinetics and Pharmacodynamics
* Intervention Model: Single Ascending Dose (SAD) study
* Allocation: Randomized Non-Stratified

Eligibility Criteria:
Inclusion Criteria:

* Healthy population

  * Untreated low density lipoprotein cholesterol (LDL-c) ≥ 130 and ≤ 190 mg/dL and triglycerides ≤ 200 mg/dL
  * Body Mass Index (BMI) of 18 to 35 kg/m2 inclusive
  * Men and women, ages 18 to 65 years, inclusive
* Statin population

  * Patients with hypercholesterolemia on stable statin therapy for 6 weeks prior to enrollment
  * At enrollment, LDL-c ≥ 100mg/dL and triglycerides ≤ 200 mg/dL
  * Patients with controlled hypertension on a stable dose of no more than two antihypertensive drugs
  * BMI of 18 to 37 kg/m2 inclusive
  * Men and women, ages 18 to 75 years inclusive

Exclusion Criteria:

* Healthy Population

  * Subjects with fasting LDL-c \< 130 or \> 190 mg/dL, or fasting triglycerides \> 200 mg/dL
  * Subjects at increased 10-year cardiovascular risk of ≥ 20% based on Framingham risk score
  * Subjects with any significant acute or chronic medical illness at the time of screening, including history of cancer, known history of sickle cell disease or trait, and known history of thalassemia
* Statin population

  * Patients with fasting LDL-c \< 100mg/dL, or fasting triglycerides \> 200 mg/dL on statin therapy
  * Patients on prescription or over the counter lipid-lowering therapy other than statin therapy
  * Patients with established atherosclerotic vascular disease
  * Patients with diabetes who are requiring oral or injectable anti-diabetic drug therapy
  * Patients with uncontrolled hypertension or controlled hypertension requiring more than two antihypertensive drugs
  * Patients with any significant acute or chronic medical illness that is severe, progressive or uncontrolled at the time of screening
* Use of any lipid lowering medication including over the counter products (eg, niacin \> 500 mg; omega-3 fatty acids \> 1000 mg; red rice yeast; phytosterols or stanol esters) for lipid lowering within 30 days prior to screening visit (42 days for fibrates) with the exception of stable statin therapy in the target disease population
* Prior treatment with any monoclonal antibody or investigational protein biologic within the preceding one year before study drug administration
* Concurrent or use within 3 months of study drug administration of marketed or investigational systemic or inhaled corticosteroids or other immunosuppressant drugs, and within 6 weeks for topical corticosteroids
A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC)

This single arm study will assess the safety and efficacy of Endostar combined with chemotherapy (Gemcitabine plus Platinum-based chemotherapy) followed by Endostar maintenance therapy in patients with stage IIIB/IV non-small cell lung cancer (NSCLC).

All eligible patients will receive Endostar in combination with Gemcitabine plus Platinum-based chemotherapy for 4 cycles (21 days for each cycle). Endostar treatment will continue after completion of chemotherapy cycles until disease progression. Efficacy will be evaluated every two cycles.

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of inoperable stage IIIB/IV NSCLC
* At least one measurable lesion
* Age of 18-75 years
* Life expectancy \> 3 months
* ECOG performance status 0-2
* Adequate hematologic, renal, and hepatic function

Exclusion Criteria:

* Prior systemic chemotherapy for NSCLC
* Evidence of any unstable diseases (serious infection, grade 4 hypertension, unstable angina, congestive heart-failure, compromised renal or hepatic function, nonhealing wound or bone fracture)
* Concurrent anticoagulation therapy
* Evidence of bleeding diathesis or coagulopathy
* Pregnant or lactating women
* Allergic to E.coli preparation
Evaluation of Bioavailability and Metabolism of Diet Phenolic Compounds

This study aims at studying in depth the absorption and metabolism of phenolic compounds of olive oil, wine and beer. This study is divided into 2 sub-studies in order to evaluate each one of the objectives.

The study is divided in two sub-studies to explore each objective.

One the one hand, a group of people will drink olive oil, or wine, or both. This is done to see if combining these two drinks will improve the absorption and bioavailibility of phenolic compounds that they contain, promoting by synergy their antioxidant activity at a postprandial level. The main compounds studied are the Resveratrol (RSVT), the Hydroxytyrosol (HT), tyrosol (TIR) and their metabolits.

One the other hand, an group of people will drink 3 different beers ( with 3 different degrees of alcohol), or wine, in order to study the absorption of TIR in relation to the alcohol degree. It also aims at assessing if the gas contained in beer contributes to TIR absorption.

At different times after the administration of drinks, urine and blood samples will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Men and women from 18 to 45 years old.
* Understand and accepting the procedures of the trial and sign an informed consent.
* Have a history and physical exams that show that there is no organic issue, and an analysis and ECG in the normal limits.
* Have an BMI between 18.5 and 30 kg/m2.
* caucasian race

Exclusion Criteria:

* Smokers
* Persons with chronical disease
* Persons with BMI\>30 or \<18.5 kg/m2.
* Persons with history of multiple allergies or obvious intestinal, hepatic, renal issues or other problems that could suppose a deterioration of absorption, distribution or metabolism of polyphenols.
* Persons who take anti-oxidant products, including vitamins, herbal medication or dietetics complementation that could interfere in the study objectives.
* Persons with restrictive diet (including vegetarian diet).
* Persons with history of hypersensibility or intolerance to alcohol.
* Persons with a daily consumption of alcohol \>50g or who have consumed illegal drug in the month preceding the study.
* Persons who have participated in an other clinical trial the month preceding the study.
* Persons who have done a blood donation during the last 3 months before the beginning of the study (only appliable to the subjects of A sub-study).
* Persons who have a positive serology for B or C hepatitis or HIV.
* Pregnant or breastfeeding women, or any other situation prohibiting alcohol consumption.
* Persons who have consummed NSAIDs (especially acetylsalicylic acid) or antioxidants or vitamin complementation, during the 2 weeks preceding the beginning of the study.
* Illiterate persons
Tolerability and Safety of An Infant Formula

The purpose of this study is to evaluate an extensively hydrolyzed formula in infants with cow's milk allergy.


Eligibility Criteria:
Inclusion Criteria:

* clinically diagnosed CMA
* \</= 12 weeks at time of study entry
* full-term infant
* must be willing to use provided formula as sole source of nutrition
* other than CMA, infant must be otherwise healthy

Exclusion Criteria:

* underlying or confounding gastrointestinal abnormalities
* infants born from an addictive situation, HIV positive
* if parent/guardian is considered likely to be non-compliant with the protocol requirements
Deep Learning Reconstruction Algorithms in Dual Low-dose CTA

The goal of this observational study is to evaluate the impact of deep learning image reconstruction on the image quality and diagnostic performance of double low-dose CTA. The main question it aims to answer is to explore the feasibility of deep learning image reconstruction in double low-dose CTA.

1. The raw data from patients who underwent head and neck CTA, coronary CTA, and abdominal CTA in both standard dose and double low-dose groups were included.
2. Techniques such as filtered back projection, iterative reconstruction, and deep learning reconstruction were performed.
3. The feasibility of deep learning reconstruction in double low-dose CTA was evaluated based on image quality and diagnostic performance.

Eligibility Criteria:
Inclusion Criteria:

* Patients with head and neck CTA, coronary artery CTA, and abdominal CTA due to stroke, coronary heart disease and abdominal inflammatory disease, and abdominal tumors.

Exclusion Criteria:

* Age \<18 years, pregnancy, allergic reaction to iodine contrast agent, renal insufficiency, and severe hyperthyroidism.
Partial Modified Blair Incision on Benign Tumor Parotidectomy Scar's Characteristics

Parotidectomy is the treatment of choice for tumors in the parotid gland, with the modified Blair is the most common incision used. In our medical center, the incision is tailored to the size and location of the specific parotid tumor. This retrospective analysis aims to determine the incidence of complications and to assess the relation between the mass and scar characteristics in patients who had undergone parotidectomy.

The scar characteristics of patient who had undergone parotidectomy for benign neoplasms at our medical center between 2013 and 2019 will be evaluated. Patients will complete a questionnaire regarding the occurrence of complications.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years during the surgery
* Clinical diagnosis of a benign parotid pathology

Exclusion Criteria:

* A malignant pathology of the parotid gland
* Unavailable data
Sensory Workshops and Anorexia Nervosa

In the literature the use of olfactory dimension in the treatment of anorexia has not been verified experimentally. The investigator hypothesize that the therapeutic use of a dietary nature olfactory stimuli in anorexia nervosa promotes food recovery. The team propose a prospective study over a period of 12 months in which we use the Body Mass Index (BMI) as the primary endpoint of the state of anorexia nervosa patients.

As part of the unit that specializes in eating disorders in adolescents, we see patients decreased taste and smell sensory abilities. Since 2006, we have implemented various sensory workshops: olfactory, tactile-kinesthetic and auditory. The establishment of this therapeutic practice that is centered on oral sphere and all respect, it was observed a decrease of 30% of the length of hospitalization. All the data we currently have in the field, suggests a rehabituation food odors and facilitate the recall of memories related to food in anorexic patients. However in the literature the use of olfactory dimension in the treatment of anorexia has not been verified experimentally. The investigator hypothesize that the therapeutic use of a dietary nature olfactory stimuli in anorexia nervosa promotes food recovery. The team propose a prospective study over a period of 12 months in which we use the Body Mass Index (BMI) as the primary endpoint of the state of anorexia nervosa patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of anorexia nervosa according to DMS IV-TR (Diagnostic and Statistical Manual of Mental Disorders) criteria.
* Follow Outpatient care or hospitalization
* Able to respond to the clinical evaluation questionnaires
* Affiliated to the social security system
* Consentement Informed of the legal representative and the patient

Exclusion Criteria:

* Somatic comorbidity associated diabetes, celiac disease, brain tumor.
* Intolerance Odors, predisposition to develop asthma and / or respiratory allergies.
* Pathologie Chronic of nose and sinus.
* Hyposmic Or anosmic.
A Long-term, Open-label, Uncontrolled Trial of YM443 (Z-338) in Patients With Functional Dyspepsia

To examine the safety and efficacy of Z-338 (YM443) after long-term administration in patients with functional dyspepsia, and also to examine the pattern of long-term administration.


Eligibility Criteria:
Inclusion Criteria:

* Patient showing at least one of the following 4 symptoms from more than 6 months before obtaining consent

  * postprandial fullness
  * early satiation
  * upper abdominal pain
  * upper abdominal discomfort
* Patient showing at least 2 of the 8 symptoms shown below repeatedly from 3 months before obtaining consent (At least one symptom of either postprandial fullness or early satiation should be included.)
* Patient showing either postprandial fullness, bloating in the upper abdomen, or early satiation as the major complaint among the 8 symptoms shown below at the time of obtaining consent

  * upper abdominal pain
  * upper abdominal discomfort
  * postprandial fullness
  * bloating in the upper abdomen
  * early satiation
  * nausea
  * vomiting
  * belching
* Outpatient

Exclusion Criteria:

* Patient showing symptoms of organic disease (reflux esophagitis, erosion, ulceration, esophageal hiatal hernia, bleeding, malignant tumor, Barrett's esophagus) when upper gastrointestinal endoscopy is performed within 24 weeks before obtaining consent
* Patient showing heartburn within 12 weeks before obtaining consent
* Patient complicated by irritable bowel syndrome
* Patient complicated by diabetes mellitus requiring medication
* Patient complicated by severe anxiety disorder with some problems in interpersonal relationships or social life
* Patient complicated by depression (including suspected cases) or sleep disturbance
Study to Evaluate the Pharmacokinetic Characteristics of CKD-4101 (Mycophenolate Mofetil) Tablet

The purpose of this study is to evaluate safety and tolerance by comparing pharmacokinetic characteristics between the CKD-4101 tablet and Mycophenolate mofetil capsule when administered alone to healthy volunteers.

Healthy volunteers are administrated single-dose over the period I and II (Crossover) of CKD-4101 1000mg and Mycophenolate mofetil capsule 1000mg.

Every time before and after each medication, PK parameters and safety of CKD-4101 tablet and Mycophenolate mofetil capsule is performed using a blood sample and conducting some tests respectively.

Eligibility Criteria:
Inclusion Criteria:

* Between 20 aged and 45 aged in healthy males
* Weight more than 45 kg, IBW ± 20% within the range

  * Ideal body weight = (Height cm - 100) x 0.9
* Agreement with written informed consent

Exclusion Criteria:

* Subject has symptoms of acute disease within 28 days of starting administration of investigational drug
* Subject with known for history(such as inflammatory gastrointestinal disease, gastric or duodenal ulcer, liver diseases and so on) which affect the ADME of drug
* Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, Blood system, digestive system, central nervous system, mental disease or malignancy disease.
* Inadequate subject by medical examination(medical history, physical examination,ECG, laboratory test) within 28 days of starting administration of investigational drug
* Inadequate result of laboratory test

  * AST or ALT \> 1.25 x upper limit of normal range
  * Total bilirubin \> 1.25 x upper limit of normal range
  * Abnormal level of WBC, Platelet, Hemoglobin WBC \< 3.5 x 1000/µL PLT \< 100 x 1000/µL Hemoglobin \< 11g/dL
* Clinically significant allergic disease(Except for mild allergic rhinitis seems to be not need for medication)
* HGPRT(Hypoxanthine-guanine phosphoribosyl-transferase)deficiency patient such as Lesch-Nyhan syndrome and kelley-Seegmiller syndrome
* Severe renal dysfunction: Creatinine clearance less than 50ml/min by cockroft-Gault calculation
* Subject with known for hypersensitivity reaction to mycophenolic acid and mycophenolate mofetil analog
* Previously participated in other trial within 60 days
* Treatment with dug-medicated induction/inhibition metabolic enzyme such as barbiturates within 1month or with may affect the clinical trial within 10 days
* Unusual diet may affect the ADME of drug
* Not able to taking the institutional standard meal
* Previously make whole blood donation within 60 days or component blood donation within 20 days
* Continued to be taking caffeine (caffeine \> 5 cup/day), drinking(alcohol \> 30 g/day) and during clinical trials can not be drunk or severe heavy smoker (cigarette \> 1/2 pack per day)
* An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result
Effects of Gait Training With Assistance of a Robot-Driven Gait Orthosis in Hemiparetic Patients After Stroke

The purpose of this study is to investigate the effects of robot-assisted gait training on active walking in the patients with stroke.


Eligibility Criteria:
Inclusion Criteria:

* 1st-ever-stroke
* hemiplegic patient after stroke
* who can stand independently, but cannot walk more than 10 meters independently
* whose muscle powers of hip and knee are more than poor on manual muscle test

Exclusion Criteria:

* previous gait difficulty before stroke onset
* arthralgia on lower extremity
* uncontrolled hypertension or hypotension
* severe medical illness
Effect of Corrective Exercises on Dynamic Knee Valgus

Dynamic knee valgus (DKV) is a movement pattern of the lower limb potentially consisting of a combination of adduction and internal rotation of the femur, knee abduction, tibial anterior translation, tibial external rotation and ankle eversion. Average "normal" performance during a fall jump landing mission knee valgus angle should be in the range of 7-13 degrees in women and 3-8 degrees in men. This faulty movement pattern is a common dysfunction observed in the lower limb during dynamic activities. On the other hand, this is reported to be the underlying mechanism of knee injuries. Changes in knee valgus increase abnormal stresses on the tibiofemoral joint and increase the risk of injuries such as anterior cruciate ligament injuries, patellofemoral pain, iliotibial band syndrome, chronic ankle instability, acute lateral ankle sprains. The main cause of DKV is deficits in neuromuscular control and therefore injury prevention and rehabilitation strategies focus on improving neuromuscular control to avoid these injury mechanisms. There are conflicting results in the literature regarding which of the exercise approaches is superior for DKV, and there is a lack of studies evaluating 2D movement analysis, muscle mechanics and performance of corrective exercise training. Identifying individuals with abnormal movement patterns and those at risk is important to prevent future injuries. The aim of the study was to investigate the effect of corrective exercises on lower extremity biomechanics and performance in individuals with asymptomatic dynamic knee valgus.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 25 years of age
* Have asymptomatic dynamic knee valgus
* Being woman

Exclusion Criteria:

* BMI≥ 30 kg/cm2
* Lower extremity musculoskeletal pain
* Lower extremity injury in the past 1 year
* History of lower limb surgery
* Neurological condition that may affect balance and coordination during the test
* More than half an hour of intense exercise per week
* Those who exercise vigorously for more than half an hour per week