cyrilzakka/clinical-trials huggingface dataset:
Adapted Physical Activity Program (APA) for Effort Rehabilitation of Children and Teenagers With Marfan Syndrome

This research study aims to evaluate the effect of a 6-month adapted physical activity program (APA) on the endurance capacities (evaluated as the maximum oxygen consumption \[VO2 peak\] on a cardiopulmonary exercise test) of children and adolescents with Marfan syndrome or related.

Marfan syndrome (MFS) is characterized by the association of multisystem damage related to connective tissue fragility. The risk of aortic dissection has diverted attention from significant musculoskeletal damage despite commonly reported extreme fatigue and pain with impact on the patient's quality of life. In a recent study (Marfanpower, NCT03236571), investigators have observed reduced endurance capacities in children and teenagers with MFS (average VO2 peak at 60% of expected), which were significantly increased by an intensive rehabilitation program. Based on this experience, investigators aim to evaluate the effect of a physical activity program adapted to the daily life of the young patients on their endurance capacities and their quality of life. This program will be set up by an adapted physical activity (APA) coach after a complete assessment, including a cardiopulmonary exercise test with VO2 peak measurement, which will be carried out in the Reference Centre for Marfan syndrome at the Toulouse University Hospital. The VO2 peak evolution will be evaluated after 6 months of program. This is a recognized parameter for the evaluation of endurance and has been validated in children. Investigators hypothesize that the implementation of a physical activity program adapted to the daily life and interests of the child with MFS will efficiently improve endurance, prevent deconditioning and promote long term benefits.

Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed Marfan syndrome or related syndrome
* Girl or boy aged 7 to 17
* Informed and written consent signed by at least one of the two holders of parental authority
* Patient affiliated to a social security scheme or equivalent

Exclusion Criteria:

* Cardiac contraindications to the APA program:

  * Severe aortic dilation (aortic diameter \> 45 mm)
  * and/or left ventricular failure (left ventricular ejection fraction \<45%)
  * and/or severe mitral leakage ≥ grade 3
* Pregnancy
A Single-Center, Open-Label, Study of the Plasma Pharmacokinetics and Safety of AC-170 0.24%

The purpose of this study is to evaluate the Plasma Pharmacokinetics and Safety of AC 170 0.24% in Healthy, Adult Subjects when used twice daily for one week.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 and no older than 55 years of age
* be able to self-administer eye drops or have a parent/legal guardian available for this purpose
* have blood and urine analysis within normal limits
* have ocular health within normal limits

Exclusion Criteria:

* known contraindications or sensitivities to the study medication or its components
* have any active systemic or ocular disorder (other than refractive disorder)
* have inability to comply with controlled diet
* have used prescription or non prescription drugs within washout period and throughout study
* have used alcohol or tobacco within the washout period
STA-9090 for Treatment of AML, CML, MDS and Myeloproliferative Disorders

The purpose of this study is to characterize the safety and efficacy of STA-9090 (ganetespib) in subjects with hematologic malignancies.


Eligibility Criteria:
Inclusion Criteria

* Males and females 18 years or older
* Eligible subjects must have one of the following relapsed or refractory hematologic malignancies: AML, MDS, CML, or myeloproliferative disorders as defined in the protocol
* Must have acceptable organ function during screening as defined in the protocol

Exclusion Criteria

* Pregnant or breast-feeding women
* Patients must meet the washout periods for prior chemotherapies and radiation
* History of stroke within 6 months of treatment
* Poor venous access for study drug administration
* Treatment with chronic immunosuppressants
* Other severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation
Spinal Anesthesia for Cesarean Delivery: Bupivacaine With or Without Fentanyl

The safest form of anesthesia for Cesarean section is a spinal anesthetic. All spinal anesthetics contain a local anesthetic and/or a narcotic. A drug named bupivacaine is the most commonly used local anesthetic in spinal anesthetics for Cesarean deliveries in North America. Another drug named fentanyl is the most commonly used narcotic. This study will look at whether a spinal anesthetic with 15mg of bupivacaine alone will be the same as a spinal anesthetic with 12mg of bupivacaine and 15ug of fentanyl.

There have been many studies looking at different doses and combinations of bupivacaine and fentanyl but there is no agreement among anesthesiologists as to the best combination of drugs.

The main problem with bupivacaine is that it causes hypotension (low blood pressure). When fentanyl is added to bupivacaine, a lower dose of bupivacaine can be used so that there is less of a fall in blood pressure. The main problem with fentanyl is itchiness and sleepiness. In the case of an emergency Cesarean section, the extra time needed to draw-up and administer a second medication may make a difference to the health of the baby.

Our goal is to determine whether high dose bupivacaine (15mg) alone will produce spinal anaesthesia for cesarean delivery equivalent to 12mg of intrathecal hyperbaric bupivacaine in combination with 15ug of intrathecal fentanyl.

Eligibility Criteria:
Inclusion Criteria:

* healthy patients (ASA 1 or 2)
* BMI \< 40
* height between 5 \& 6 feet

Exclusion Criteria:

* parturients with pregnancy induced hypertension or preeclampsia
* parturients with significant cardiac, renal or other organ-system disease which preclude choice of spinal anesthesia
* emergency delivery
* triplet or greater multiple gestation
Clinical Study of Chondro-Gide® for Large Chondral Lesions in the Knee

Multi-center, prospective, concurrently controlled, non-randomized, double-blind (patient and assessor). Treatment of large chondral lesions in the knee with microfracture plus the Chondro-Gide® ACC is non-inferior to treatment of small chondral lesions treated with microfracture alone.

The study evaluates the investigational treatment for treating large chondral lesions of the knee to the control treatment of microfracture alone for treating small lesions.Eligible patients with a large lesion will be treated with microfracture plus the Chondro-Gide® ACC and compared to patients with small lesions that are treated with microfracture alone. Outcome measures to be assessed include patient reported outcomes and freedom from certain adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent
2. One symptomatic knee with cartilage defect on the medial femoral condyle, lateral femoral condyle, or trochlea, identified MRI or arthroscopy
3. Between 18 and 55 years of age
4. Subject is willing and able to comply with all study procedures, including visits, diagnostic procedures, and the rehabilitation protocol

Exclusion Criteria:

1. BMI ≥ 30 kg/m2
2. Symptomatic contralateral knee
3. Diagnosis of radiographic osteoarthritis with Kellgren-Lawrence grade 3 or more
4. Prior surgical treatment of the cartilage using microfracture, mosaicplasty, or autologous chondrocyte implantation (debridement and lavage are acceptable if the procedure was at least 3 months prior to enrollment)
5. Patella dysplasia
6. Chronic inflammatory arthritis or infectious arthritis
7. History of autoimmune disease or immunodeficiency
8. History of connective tissue disease
9. Intra-articular steroid use within the 3 months prior to enrollment
10. Other intra-articular injections (e.g. hyaluronic acid) within 3 months prior to enrollment
11. The patient is currently being treated with radiation, chemotherapy, immunosuppression or systemic steroid therapy with a dose equivalent to more than 5 mg prednisolone
12. Pregnancy or lack of adequate contraceptives if a female of child-bearing potential
13. Enrolled in another study, involved in the study (as a researcher/investigator/sponsor), or relative of someone directly involved in the study
14. Active infection of the index knee
15. Previous diagnosis of osteoporosis as diagnosed by DEXA, bone densitometry or CT scan
16. Any disorder or impairment that would interfere with evaluation of outcomes measures, such as neurological, degenerative muscular, psychiatric, or cognitive conditions
17. History or current substance or alcohol abuse as defined by the DSM-V
18. Any other medical condition that the investigator determines would interfere with the validity of the study
19. Known allergy to porcine collagen
20. Symptom duration greater than 36 months
The Apple Study: Two Apples a Day, Keep the Doctor Away?

The goal of this clinical trial is to learn about the gut microbiome in healthy postmenopausal women aged 50-64. The main questions it aims to answer are:

* Investigate whether the activity of the bacterial enzyme β-glucuronidase and the abundance of β-glucuronidase-producing bacteria could be decreased by ingestion of 2 apples a day for a period of 6 weeks
* Examine changes in gut microbiota composition, diversity, and functional capacity
* Examine feasibility of eating 2 apples a day for a period of 6 weeks

Participants will eat 2 apples a day for a period of 6 weeks.

Six weeks includes the period from the start of the study and gathering of baseline characteristics/questionnaires till the finish.

It is know that estrogen levels decrease after menopause. There are many different factors affecting these levels though; the gut microbiome has been identified as one of these. Not only the composition of the gut microbiota plays a role here, but also its activity is of special interest. The gut microbiota for instance produces the bacterial enzyme β-glucuronidase which has been shown to de-conjugate biliary excreted estrogens, leading to reactivation and reabsorption of estrogens into the bloodstream. It might be expected that this reabsorption results in elevated blood estrogen levels. Elevated levels of estrogen have been linked to not only development but also recurrence of breast cancer.

Apples are known for their pectin which has prebiotic properties and a potential decreasing effect on β-glucuronidase activity. In vitro studies and animal studies have already shown the β-glucuronidase decreasing impact of pectin. In humans this was never examined before.

This study aims to investigate whether it is possible to lower the activity of the bacterial enzyme β-glucuronidase and the abundance of β-glucuronidase-producing bacteria by a simple dietary intervention. This dietary intervention consists of the ingestion of two whole apples a day, one in the morning and one in the evening, during the period of 6 weeks. Thereby this study aims to examine the feasibility of this intervention.

It is hypothesized that

1. this is a feasible intervention
2. this results in a decrease in the activity of the bacterial enzyme β-glucuronidase and the abundance of β-glucuronidase-producing bacteria. Which would be in line with the findings of in vitro and animal studies and
3. an increase in microbial diversity

Eligibility Criteria:
Inclusion Criteria:

* Age 50-64
* Postmenopausal women
* Recent negative breast cancer screening (\< 6 months)

Exclusion Criteria:

* The regular consumption of one ore more apples a day
* Previous gastrointestinal surgery (excl. appendix surgery)
* Any type of cancer in history, except for basal cell carcinoma (BCC)
* Inflammatory bowel disease
* Mammography older than 6 months
* Antibiotic use within three months before fecal sampling
* Physically or mentally incapable or incompetent to sign informed consent
* Known apple allergy or complaints matching with apple allergy
* Less good dental state
Study of LLG783 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication

This study is designed to determine whether LLG783 displays the clinical safety and efficacy profile, after multiple i.v. doses, to support further development in patients with PAD and intermittent claudication.


Eligibility Criteria:
Inclusion Criteria:

* claudication, as defined by pain with exertion in either leg;
* On stable medical therapy, including statins, aspirin, and antihypertensive medications (as medically indicated) unless individually contraindicated, for at least 4 weeks prior to the screening visit;
* Vital signs must be within the following ranges:

  * body temperature between 35.0-37.5°C
  * systolic blood pressure, 90-159 mm Hg
  * diastolic blood pressure, 50-99 mm Hg
  * pulse rate, 50 - 90 bpm
* Moderately impaired ambulatory function judged by the investigator to be due primarily to PAD and assessed by a maximum walk distance between 50 and 400 meters (inclusive of these values) at the screening 6-minute walk test (6MWT).

Exclusion Criteria:

* Pregnant or nursing (lactating) women;
* Patients who meet any of the following PAD related criteria:

  * Patients actively attending and participating in a supervised exercise rehabilitation program (patients who have already completed such a program and remain symptomatic may be included).
  * Patients with any condition other than PAD that limits walking ability.
  * Known inflammatory disease of the arteries (other than atherosclerosis; e.g. Thromboangiitis obliterans).
  * Clinical evidence of critical limb ischemia including new or non-healing ulcers (felt secondary to critical limb ischemia), new or recent onset of resting pain in the lower extremities particularly at night (felt secondary to critical limb ischemia) and/or gangrene of the lower extremities (Fontaine stage III-IV) .
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 150 days after stopping of investigational drug.
* Any of the following concomitant cardiovascular or metabolic conditions or diseases:

  * Myocardial infarction within 6 months of screening.
  * Stroke within 6 months of screening.
  * History of clinically significant ventricular arrhythmias, according to the discretion of the investigator, within 6 months of screening.
  * Significant ECG abnormalities, according to the discretion of the investigator, at screening.
  * History of sustained and clinically significant supraventricular arrhythmias (e. g. associated with hemodynamic compromise) within 6 months of screening.
  * Chronic heart failure New York Heart Association Class III or IV.
  * Known presence of aortic aneurysm \> 5 cm.
  * Uncontrolled diabetes as defined by a random fasting glucose level of 13 mmol/L or 240 mg/dL or a HbA1c greater than 9% as measured at screening. Diabetes should be treated as appropriate during the study.
Exploring the Effects of Diazepam and Lorazepam

Aims :

* exploring lorazepam (0.038 mg/kg) effects, after a single oral intake, in healthy volunteers, on the neural correlates of encoding and retrieval of information during a word-stem completion task (implicit memory), using fMRI
* comparing lorazepam effects to diazepam (0.3 mg/kg)effects
* exploring benzodiazepines effects, after a single oral intake, on the neural correlates of successful encoding of information within explicit memory using fMRI

Hypothesis :

* both diazepam and lorazepam will impair explicit memory performance, but lorazepam only will impair perceptual priming
* lorazepam and diazepam will modify the normal correlates of information encoding within explicit memory
* lorazepam only will alter the neural correlates of perceptual priming


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects between 18 and 30 years
* Students in medicine, dentistry or pharmacy
* French as a mother language

Exclusion criteria:

* Medical condition influencing brain function (neurological or psychiatric)
* Asthma
* General anesthesia in the 3 last months
* Drug addiction (DSM IV criteria)
* Regular medical treatment (except contraceptive pill)
* Significant impairment observed during a medical examination including ECG
* Intake of any psychotropic drug that can have a effect during testing
* IQ (Wechsler) \< 100
* FMRI contra-indication (implantable magnetic material, claustrophobia)
* Known allergy to benzodiazepine or lactose
* \> 10 cigarettes/day
* Pregnant or breast-feeding woman
* No health insurance
* Subjects who do not complete the entire study
Two Bed SPECT/CT Versus Planar Bone Scintigraphy in Detection of Osseous Metastases in Patients With Genitourinary Malignancies

The study aims to compare the diagnostic performance of planar bone scan and two bed SPECT/CT in detection of bone metastases in patients with urogenital cancer.

Genitourinary malignancies represent a heterogeneous group of diseases linked by anatomical and physiological function. Renal cell carcinoma (RCC); urothelial carcinoma of the bladder, ureter, and renal pelvis, and prostate adenocarcinoma (PC) are the most commonly encountered histological subtypes within this group. Planar bone scintigraphy (PBS) with di-phosphonate compounds is widely used, cost-effective and sensitive imaging modality for detecting osseous metastases especially in prostate cancer. However, it suffers from low specificity as well as low sensitivity in purely osteolytic lesions. Single-photon emission computed tomography (SPECT) is a three-dimensional acquisition method that has demonstrated greater sensitivity and specificity compared to planar images, especially for detecting vertebral metastases. The introduction of SPECT/CT images improves the lesion-to-background ratio, allows anatomic lesion localization, removes the superimposition of anatomical structures, such as urinary bladder activity, and provides anatomical data, thereby increasing the sensitivity, specificity and positive predictive value of bone scan. As the technology advances, current SPECT/CT machines have become capable of sequentially covering, and accurately merging, more than one field of view (FOV) in a reasonable time. In this study, we aim to compare the diagnostic performance of two-bed SPECT/CT images and planar bone scintigraphy in detection of bone metastases in genitourinary malignancies.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with urogenital cancer referred for bone scan.

Exclusion Criteria:

* Patients with claustrophobia.
* Patients refuse to do the scan.
* Patients with relative or absolute contraindications to do the scan (eg. pregnancy).
Treatment of Diabetes After Gastric Bypass With Sitagliptin

The purpose of this study is to assess whether Januvia (sitagliptin phosphate 100mg) is safe and effective for the treatment of Type 2 Diabetes in patients who have had Gastric Bypass.

Januvia (sitagliptin phosphate 100mg) is an FDA approved medication for the treatment of Type 2 Diabetes. Sitagliptin works by inhibiting the Dipeptidyl peptidase-4 enzyme, resulting in increased active glucagon-like peptide-1 (GLP-1) levels. GLP-1 is an incretin which increases post-prandial insulin secretion. Because Gastric Bypass has also been shown to increase GLP-1 levels, this study seeks to determine the additional effect of DDP-4 inhibition on glucose control in patients who have elevated incretin levels post Gastric Bypass. The study will also assess if Januvia (Sitagliptin phosphate) is safe and well tolerated in patients after Gastric Bypass.

Recruitment and data collection for this study was started at St. Luke's Hospital in New York, NY and later moved to Columbia University Medical Center in New York, NY.

Eligibility Criteria:
Inclusion Criteria:

* Must be a resident of the NYC metropolitan area or be able to come for emergency unscheduled and regular weekly meetings in Manhattan.
* HbA1c ≥ 6.5% and ≤ 8.5 % or a fasting glucose ≥ 126 mg/dL or a random glucose ≥ 200 mg/dL at least 12 months after GBP surgery confirmed by central laboratory.
* Subject is capable and willing to give informed consent.
* Subject is otherwise in good general health, based on medical history and physical examination.
* Subject is a non smoker for at least 6 months prior to study start
* Female subjects of child bearing potential must use oral, injected or implanted hormonal methods of contraception from at least the commencement of their last normal period prior to the first administration of the challenge agent. Subjects using hormonal contraception should use a barrier method in addition from the first administration of challenge agent until their next normal period following the end of the study.

Exclusion Criteria:

* History of type 1 diabetes
* Female subject is pregnant or breastfeeding.
* Recent (\< 30 days) or simultaneous participation in another clinical trial.
* Any situation that can compromise the study, including serious illness or a predictable lack of cooperation from the subject.
Does the Mesh Have to be Fixed in Laparoscopic eTEP Repair of Bilateral Inguinal Hernia?

Inguinal hernia surgery is one of the most frequently performed procedures among general surgery cases. As with many open surgical methods, this repair is also performed laparoscopically. Among these closed methods, the one method is laparoscopic extended total extraperitoneal repair (eTEP). The benefits of laparoscope include less postoperative pain and complications, faster recovery, reduced chronic pain, and recurrence rate.

One of the recent debates regarding the laparoscopic technique is mesh fixation. Fixation of the mesh to the cooper ligament can prevent mesh migration and consequently reduce the recurrence rate. However, it has been reported that this fixation may increase postoperative pain. Several studies have reported that recurrence may be due to inadequate mesh fixation technique. In contrast, other prospective randomized studies have found relapse unrelated to mesh fixation.

There are studies in the literature on mesh fixation related to the total extraperitoneal repair (TEP) technique. These studies are generally planned for unilateral hernias. It is a controversial issue among surgeons that the possibility of mesh migration is higher in bilateral hernias since there is a larger dissection area. This discussion is the starting point of this study. There were no studies in the literature regarding mesh fixation in bilateral inguinal hernias. The aim of this study is to compare bilateral inguinal hernia patients with and without mesh fixation in the eTEP technique in terms of both mesh migration and clinical features.


Eligibility Criteria:
Inclusion Criteria:

* Patients with bilateral inguinal hernias.
* Patients aged 18-65.

Exclusion Criteria:

* Younger than 18 years, and older than 65 years
* Incarcerated or strangulated inguinal hernias,
* Recurrent hernias.
* Patients with unilateral inguinal hernias.
* Patients who are contraindicated to receive general anesthesia.
* Pregnancy
Q-Switched Nd:YAG in Macular Amyloidosis

The purpose of this study is to determine whether Q-Switched Nd:YAG Laser therapy are effective in reduction of Cutaneous macular amyloidosis.

We treat the macular amyloidosis cases by Q-Switched Nd:YAG Laser and compare the before and after treatment situation by the photos and colorimetric assessment.

Eligibility Criteria:
Inclusion Criteria:

* Macular amyloidosis confirmed cases

Exclusion Criteria:

* Pregnancy and breast feeding
* Over 18 years old