cyrilzakka/clinical-trials huggingface dataset:
Assessment of Arthroscopy in Patients Undergoing Wrist Fracture

The use of arthroscopy with the surgery of wrist fractures has a great health and economic impact (prolongs the time of surgery, requires adequately trained personnel, increases the time and surgical expenses and the risk of complications, however, in return ameliorate the prognosis and improves the functional recovery). There are few clinical trials showing a sufficient level of evidence in comparing the results of the surgical treatment of these fractures with volar plate and added arthroscopy so it is necessary to perform a clinical trial with an appropriate design and a sufficient sample size to elucidate the usefulness of arthroscopy in wrist fractures. Therefore, the investigators want to perform an open and controlled clinical trial to adequately analyze the role of arthroscopy in the surgical treatment of wrist fractures in the investigators hospitals.

The main objective of the study is to probe the arthroscopy effectiveness in the functionality of the injured wrist by PRWE (a questionnaire assessing pain and wrist function) between the treatment groups of the trial at 12 months after surgery and for this the investigators plan a phase IV multicenter clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Patients able to read and understand the same consent.
* Patients over 18 years
* Broken wrist surgery with criteria based on the following criteria (must meet all):

  * Patients functionally independent, ie, they can make the purchase without help, categorized according Mackenney or patients who require assisted support by crutches / walker for walking.
  * Radiographic unacceptable reduction after 1 attempted closed reduction in the ER, defined as:

    1. dorsal angulation\> 0 °
    2. ulnar variance\> 3mm postreduction.
    3. Step articular\> 1mm (20)
    4. radial inclination \<15 °
  * Patients with unstable fracture.

Exclusion Criteria:

* Type III open fractures of Gustilo and Anderson.
* Bilateral fractures (not acceptable include more than one doll per patient for the analysis of the variables in the study, always choosing the wrist of the dominant hand).
* Fractures associated ipsilateral upper limb affection (except distal ulnar fracture).
* Fracture or serious injury prior ipsilateral wrist.
* Medical criteria that contraindicate surgery.
* Patients with low functional demand, categorized as dependent as Mackenney, ie, they need help to go shopping and do not require assisted support by crutches / walker for walking.
* Patients with tumor lesions secondary processes (eg osteosarcoma, prostate cancer, breast cancer, multiple myeloma), congenital metabolic (eg osteogenesis imperfecta) and others involving themselves poor prognosis associated with disease.
* Women with suspected pregnancy or pregnancy can not participate in this clinical trial because the collection of monitoring data is expected performing radiographic examinations, in case of pregnancy, would be contraindicated.
Comparative Pharmacokinetics of YH14659 in Healthy Male Subjects

The objective of this study is to compare pharmacokinetics after single oral administration of 2 capsules of YH14659, a fixed-dose combination of clopidogrel and aspirin developed by Yuhan Corporation versus co-administration of Plavix (clopidogrel) and Astrix (aspirin) in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers of aged between 20 years to 55 years
* Weight: over 50kg, within ±20% of ideal body weight
* Have no history of neither congenital nor chronic disease
* Have no history of abnormal symptoms or opinions as a result of physical examination (medical checkup)
* Eligible subjects with acceptable medical history, physical examination, laboratory tests, ECG during screening period
* Subject who has signed on the written consent

Exclusion Criteria:

* Have a known allergy or hypersensitivity to anti-platelet agents
* Person with hypotension (SBP ≤ 100mmHg or DBP ≤ 50mmHg) or hypertension (SBP ≥ 150mmHg or DBP ≥ 95mmHg), person whose pulse rate is below 45 or over 100 a minute
* Have the following abnormal findings on diagnosis;

  * have AST or ALT \> 1.25 times of normal upper limit
  * have total bilirubin \> 1.5 times of normal upper limit
  * have higher PT, aPPT, BT than normal range
  * have PLT below 180,000 or above 350,000
* Patients with hemorrhage or predisposition to hemorrhage
* Have disease or history of stomach or intestinal surgery or resection that would potentially alter absorption of orally administered drugs
* Have participated in other clinical studies within 3 months prior to the first administration
* Have used any prescription medications including anti-coagulants, anti-platelet agents, thrombolytic drugs and Prostaglandin E1 agents within 2 weeks prior to the first administration or any over-the-counter, non-prescription preparations within 1 week prior to the first administration
* Patients with aspirin induced asthma(AIA) or history of AIA
* Subject who is judged to be ineligible by principal investigator or sub-investigator
Cycling Through the Menstrual Cycle

With an increase in number of female athletes in sport events, it is becoming more important to gain insight in female related sports physiology. A main difference between male anf female athletes is the menstrual cycle. During the menstrual cycle, female reproductive hormones fluctuate. These hormones are also of influence on endurance, recovery, muscle strenght and mental state. Therefore we hypothesize that training efficiancy, power and motivation to train differ during the menstrual cycle. In case there is a pattern seen during the menstrual cycle, training programs can be individualized taking the menstrual cycle into account leading to more effective training programs.

More and more women are trying to take their menstrual cycle into account when it comes to training effort, planning and performance. This is called menstrual cycle-based periodized training. However, it is still unknown what the exact influence of the different phases of the menstrual cycle is on training and performance. This includes the influence of hormonal fluctuations during the cycle on training capacity, effort load, restorative capacity, motivation to train and perform, daring to take risks and the mental aspects surrounding training and performance. As a result, general advice about cycle-based periodized training cannot be given at this time.

It has been described in the literature that professional-level cyclists regularly have menstrual cycle disorders (ie RED-s). This has short-term health consequences (less rapid recovery, fatigue) and long-term (osteoporosis, increased risk of cardiovascular disease). At a professional level, this knowledge is slowly penetrating. Less is known about the menstrual cycle of amateur athletes and there is also a lack of knowledge about the effects of the menstrual cycle on performance (endurance capacity, heart rate zones, power achieved).

To gain more insight into the menstrual cycle, the influence of the cycle on training and performance and the influence of training on the cycle of the sporting woman, the aim of this study is to monitor the menstrual cycle of female cyclists in combination with their subjective and objective training parameters. This allows us to create insight and, if useful, adapt training on an individual basis to the phase of the menstrual cycle.

The aim of this research is to investigate how the cyclists' menstrual cycle progresses and whether the cycle has an effect on performance.

Eligibility Criteria:
Inclusion Criteria:

* JOIN cycling app member
* female cyclist
* informed consent period tracking in JOIN

Exclusion Criteria:

* none
Low Dose GnRHa Early Luteal Phase Down Regulation Versus GnRHa Ultra-short Protocol for Poor Ovarian Response

The management of the poor responder patients is very difficult. Currently, there is no any standard treatment for poor responder patients. The study is designed to test a modified GnRHa protocol for poor ovarian response, low dose GnRHa early luteal phase down regulation, compare with GnRHa ultra-short protocol. This is a randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* At least two of the following three features must be present: i. Advanced maternal age (≥40 years) or any other risk factor for POR (poor ovarian response); ii. A previous POR (≤3 oocytes with a conventional stimulation protocol); iii. An abnormal ovarian reserve test (i.e. AFC \<7 follicles or AMH \<1.1 ng/ml).

Exclusion Criteria:

* Contraindications for IVF/ICSI
* Contraindications for pregnancy
* Primary ovarian insufficiency
* AFC \<3
* PGD/PGS
The Acute Effect of Grains of Paradise (Aframomum Melegueta) on REE

Grains of paradise (Aframomumu melegueta) (GP), also known as Guinea pepper or Alligator pepper, belongs to the Zingiberaceae family, which is native to West Africa. GP seeds are used as a spice and also have wide-ranging ethnobotanical uses. GP seeds are very rich in non-volatile pungent compounds such as 6-paradol, 6-gingerol, 6-shogaol and related compounds. This feature may equip them with the power to activate the Sympathetic Nervous System and thereby increase EE, which has been demonstrated in rodents. Research suggest that ingestion of GP extract can result in sustained elevation of EE and a consequent reduction in body fat. Thus, there is some evidence that GP may have a potential thermogenic effect that could be useful as part of a weight loss treatment. However, there is no information on whether GP has the potential of improving and prolonging the thermogenic effects of bioactives known to elevate fatty acid mobilization and subsequent fat oxidation. This proposal will fill a void in the literature by testing for the first time in healthy, normal weight, human volunteers whether the ingestion of GP in combination with a commercially available complex containing caffeine, green tea, and forskolin has an enhanced acute effect on REE, the largest and most stable component of EE, as well as the ratio of fat:carbohydrate oxidation. This project will provide pilot data to support larger studies such as prospective studies and studies to compare the thermogenic effect with currently available compounds.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-65 years
* Men and women
* Able to provide written consent in English
* A body mass index between 18.5 and 30 kg/m2

Exclusion Criteria:

* Current smoker
* Claustrophobia
* Use of any prescribed or over-the-counter medication affecting metabolism
* Suffering from cardiac, hepatic, renal, pulmonary, endocrine or hematological disease
* Currently pregnant or breastfeeding
* Consuming more than 300mg of caffeine per day
* Consuming more than 2 alcoholic beverages per day.
* Performing more than 3 hrs/week of strenuous exercise
* Weight loss of more than 5% of body weight over the past 6 months
* Not willing to abstain from alcohol, caffeine and exercise for 24hr before each test day.
* Suffering from heartburn or a sensitivity to pungent compounds in foods
Monitoring of the Bone Free Flaps With Microdialysis

Microdialysis is admitted to be reliable by numerous surgeons to monitor flaps. Nevertheless, a few authors reported follow up with microdialysis in bone free flaps, and they all describe the position of the catheter in the surrounding soft tissue muscle which is not the accurate reflect of bone vascularisation. The aim of this study is to determine the lactate/pyruvate ratio mean value in bone free flaps with a microdialysis catheter directly positioned in the bone tissue.

Failure rate of facial reconstructive surgery with bone free flaps varies between 11 and 25%. In case of buried bone free flaps, the follow up is even more difficult. Monitoring methods, such as the implantable Doppler system, laser Doppler flowmetry and microdialysis have been developped in the last 15 years. Ferguson et al. show a false positive rate of 31% with implantable doppler monitoring of buried flaps.

The purpose of this study is to to determine the lactate/pyruvate ratio mean value in bone free flaps with a microdialysis catheter directly positioned in the bone tissue.

Eligibility Criteria:
Inclusion Criteria:

* adult person
* signed informed consent
* head and neck reconstruction with iliac crest or fibula free flap
* patient covered by national health insurance

Exclusion Criteria:

* minor person
* head and neck reconstruction with other types of free flaps than crest or fibula free flap
* pregnant or breastfeeding women
Comparison Between the Right Lateral Decubitus and the Left Lateral Decubitus as Starting Position in Colonoscopy

Randomized Clinical trial between two positions to initiate colonoscopy, Right Sided vs Left Sided

Objective To assess whether in the colonoscopy, the initial position of the patient in the right lateral decubitus (DLD) translates into advantages such as: shorter examination time or greater range of detection of polyps, compared to the left lateral decubitus (DLI), a position traditionally used.

Methodology This is a randomized and controlled clinical trial to be carried out in the city of Bogotá, in the Gastroenterology and Digestive Endoscopy Unit of the Colombia University Clinic, a fourth-level private clinic, a unit in which 7746 colonoscopies were performed in 2017.

The study will be carried out over a period of 2 months until the sample is completed.

Patients will be randomized to start their colonoscopy in the right lateral decubitus or left lateral decubitus and it would be assessed, the time to reach transverse colon, cecum and comfort perceived by the gastroenterologist and the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for diagnostic colonoscopies in the digestive endoscopy unit.

Exclusion Criteria:

* Therapeutic colonoscopies.
* Patients with a history of colonic resection.
* Patients who cannot give their informed consent.
* Under 18 years old.
* Pregnant women.
* Patients with significant cardiopulmonary, renal or psychiatric disease.
Microbiota Study in Liver Transplanted Patients

Many studies describe the relationship between microbiota alteration and the occurrence of metabolic, alcoholic or inflammatory liver diseases. Nevertheless, the modifications of microbiota during liver transplantation (LT) as well as its implication are poorly studied. Similarly, only the intestinal microbiota is studied in this context, and no data are available on the biliary microbiota, even if it is known that bile microbiota can interfere with hepatobiliary diseases.

This study proposes a clinical and biological in-depth follow-up with multiple sampling of liver transplanted patients to study biliary and intestinal microbiota alterations along LT, as well as bile acids metabolism in corresponding fluids.

Indeed, in recipient samples as saliva, blood, urine, and feces can be taken before LT, and surgeons can easily perform bile sampling during LT. In donors all samples can be taken during liver removal. This offers the opportunity to have a microbiotic landscape of individuals without liver disease (donor), and patients suffering from a chronic liver disease or a liver cancer before and after transplantation.

Also, in Grenoble University hospital, in case of biliary anastomotic incongruence, a biliary stent is placed during LT in 60% of recipients. This stent is removed by endoscopic retrograde cholangiopancreatography (ERCP) within 6 months after LT, offering a second opportunity to obtain bile samples in transplanted patients, after the early post-LT period. Patients who do not require a biliary stent will also be included for the study of secondary objectives, as intestinal microbiota is very poorly characterized in liver transplanted patients too. A portion of the patients without biliary stent, may also develop an anastomotic biliary stricture requiring an ERCP. If this ERCP is realized within the follow-up period of the study, the patient will also be included in the primary objective of the study.

These multiple and sequential samples will allow a complete analysis of microbiota changes in LT patients and aim to answer to 3 questions:

1. What are the modifications of intestinal and biliary microbiomes during LT?
2. What is the influence of bile acids' composition on intestinal and biliary microbiota?
3. What are the relationships between microbiome alterations and the emergence of LT complications?


Eligibility Criteria:
Inclusion Criteria:

Recipients:

* Age ≥ 18 years old
* Absence of LT contraindications
* Patient undergoing liver transplantation
* Patient legally able to give written consent.
* Person affiliated to social security

Donors:

Cadaveric-donor liver transplantation

Exclusion Criteria:

* Living-related liver transplantation
* LT contraindications
* All subjects protected by articles L1121-5 and L1121-8 of French public health law (Subject under administrative or judicial control, person who are protected under the act, person hospitalized without their consent, prisoners and pregnant or breast-feeding women).
Safety, Tolerability, PK & Efficacy of V81444 in Volunteers With Attention Deficit/ Hyperactivity Disorder (ADHD)

The purpose of this research study is to evaluate the safety, tolerability, effectiveness, and pharmacokinetics (PK) of twice daily oral doses of V81444 in adults with ADHD. Pharmacokinetics (PK) is the study of how a drug is absorbed, distributed, metabolized, and eventually eliminated by the body. Pharmacokinetics is what the body does to the drug. Blood samples will be taken throughout the study for PK analysis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must:

  1. Be male or female subjects aged 18 to 50 years inclusive
  2. Meet DSM-IV-TR criteria for a primary diagnosis of ADHD combined, hyperactive-impulsive or predominantly inattentive type; confirmed by a minimum score of 24 on the ADHD-RS with adult prompts:
  3. Have a body mass index (BMI) between 19 and 32 kg/m2 inclusive
  4. Be willing and able to comply with the requirements of the entire study
  5. Be able to read and understand English
  6. Give written informed consent

Exclusion Criteria:

1. Have a significant medical condition or a history of such a condition that the Investigator considers should exclude the subject from the study
2. Have any other significant psychiatric disorder, as determined by the Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID-I)
3. Have known mental impairment defined as an intelligence quotient (IQ) less than 75, or clinical evidence of mental impairment based on the opinion of the Investigator
4. Have a history or evidence of clinically significant GI disease, including ulcers, gastro-esophageal reflux disease, hiatus hernia or gastritis
5. Have had any previous gastric surgery and/or bariatric procedure
6. Have any known malformations that would make EGD difficult or unsafe
7. Have taken any prohibited concomitant medication
8. Have multiple drug allergies or be allergic to any of the components of V81444 study medication or its matching placebo (see Section 7.1) or lidocaine
9. Have abused drugs in the 12 months before study drug administration
10. In the 90 days before study drug administration, on average

    * have smoked more than 5 cigarettes per day
    * have consumed more than 28 units of alcohol per week
    * have consumed more than 500 mg of caffeine per day
11. In the 2 calendar months before study drug administration

    * have donated blood or plasma in excess of 500 mL
    * been exposed to any new investigational agent
12. In the calendar month prior to screening

    * used non-steroidal anti-inflammatory drugs regularly
    * had a new tattoo or body piercing
13. Have any clinically relevant abnormal findings at Screening and/or admission
14. Plan to undergo elective procedures/surgery at any time during the study
15. Have any other condition that might increase the risk to the individual or decrease the chance of obtaining satisfactory data, as assessed by the Investigator.
Prospective Observational Clinical Study on Changes in Cognitive Levels in Elderly Patients Before and After Hematopoietic Stem Cell Transplantation

To investigate the potential improvement in cognitive levels in elderly individuals following hematopoietic stem cell transplantation, which will help better understand the changes in cognitive levels after transplantation in elderly patients, providing crucial reference for future clinical practice and research.

To investigate the potential improvement in cognitive levels in elderly individuals following hematopoietic stem cell transplantation, which will help better understand the changes in cognitive levels after transplantation in elderly patients, providing crucial reference for future clinical practice and research.

To observe changes in cognitive levels in patients aged ≥55 years receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT) before and after allo-HSCT.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 55 years;
2. Patients planning to undergo allogeneic hematopoietic stem cell transplantation.

Exclusion Criteria:

1. Patients with active diseases;
2. Presence of central nervous system tumor invasion;
3. Planning to undergo two or more transplantations;
4. Severe cognitive impairments or mental illnesses;
5. Inability to communicate in Mandarin.
Safety Study of Recombinant NAPc2 to Prevent Tumor Progression and Metastases in Metastatic Colon Cancer

This is a multicenter, two-stage trial with the goal of evaluating up to 100 subjects. This trial will be performed to initiate identification of a safe and effective dose of twice-weekly, subcutaneous rNAPc2 for the second-line treatment of metastatic colorectal carcinoma in combination with contemporary 5-FU-based chemotherapy.

Cytotoxic chemotherapy combining 5-fluorouracil and leucovorin with irinotecan (FOLFIRI) or oxaliplatin (FOLFOX) or, more recently, treatment with XELOX (Roche) (capecitabine + oxaliplatin) has been the main approach for the treatment of metastatic colorectal carcinoma (mCRC), but with the advent of targeted therapies, biologic treatments are becoming an area of intense interest. Tissue factor (TF) is a transmembrane glycoprotein expressed by upwards of 85% of mCRCs.

Eligibility Criteria:
* Tissue diagnosis of adenocarcinoma of the colon or rectum
* Documented metastatic disease with at least one measurable lesion by RECIST criteria
* Previously treated with 5-FU-based chemotherapy in the form of FOLFIRI, FOLFOX, or XELOX plus bevacizumab as first-line chemotherapy and have recorded progressive disease during treatment or after discontinuation of treatment, when discontinuation of treatment occurred less than 6 months before enrollment (Stage I) or randomization (Stage II)
* Estimated life expectancy of at least 6 months
* Age 18 to 75 years
* Last dose of adjuvant or radiosensitizing chemotherapy less than 6 months before enrollment
* No other active malignancy for which the subject is currently receiving treatment (other than mCRC)
* No ongoing therapy with or need for parenteral and oral antithrombotics including anticoagulants and anti-platelet agents (including aspirin) and thrombolytics
* No contraindication to systemic anticoagulation
* No contraindication to modified FOLFOX6 or FOLFIRI combination chemotherapy
* No receipt of any investigational compound within 28 days of enrollment