cyrilzakka/clinical-trials huggingface dataset:
Quartet Lead and Resynchronization Therapy Options

The purpose of this Clinical Trial is to determine the percentage of patients whose hemodynamic response improves with the different configurations offered by the new Quartet® left ventricular lead, as a result of its four electrodes, with respect to the configurations offered by a standard bipolar lead.

Furthermore, the optimal stimulation configuration will be determined from a comparison with traditional configurations.

This is a prospective, non-randomised, multi-centre, national, interventional clinical trial of a medical device.

This trial involves two visits: one at the beginning of the study, which will be undertaken in the seven days following implant, and another visit at 6 months after enrollment. It is recommended that the enrollment visit is undertaken as soon as possible after implantation, although the time window allows the timing to be adapted to each centre's standard practice. Resynchronization therapy in those patients suitable for participation in this trial is expected to begin once this enrollment visit has been completed.

Once data collection at enrollment visit has been completed, final device programming will be based on each investigator's criteria and will be undertaken following the standard practice of each centre.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a Cardiac resynchronization Therapy Defibrillator device (CRT-D) and a Quartet® quadripolar electrode from St Jude Medical (used in "Single Site Pacing" mode) implanted in the left ventricle.
2. Patients who have provided written informed consent
3. Patients who are in sinus rhythm.
4. Patients older than 18 years of age.

Exclusion Criteria:

1. Patients in atrial fibrillation at the time of the echocardiographic study of the enrollment visit.
2. Patients with valvular disease.
3. Patients in functional class New York Heart Association (NYHA) IV
4. Patients for whom echocardiography images suitable for determining the cardiac output cannot be obtained.
5. Patients whose device has been changed/upgraded.
6. Pregnant patients.
7. Patients who do not fulfill all the inclusion criteria.
8. Patients who are unable to provide written informed consent
Safety and Pharmacodynamics of GNSC-001 Intra-articular Injection for Knee Osteoarthritis

The goal of this clinical study is to determine if a single injection of 1 or more dose levels of adeno-associated virus (AAV) gene therapy (GNSC-001) is safe and tolerated compared to placebo in participants with painful osteoarthritis (OA) of the knee.


Eligibility Criteria:
Key Inclusion Criteria:

* OA in at least one knee (the 'target knee'), confirmed using centrally read X-ray with a Kellgren-Lawrence (KL) score of 2 or 3
* Western Ontario \& McMaster University Osteoarthritis Index (WOMAC) pain score ≥ 20 (on a 50-point numerical rating scale) in the target knee during the seven days prior to Screening
* Persistent moderate to severe symptoms in the target knee, despite failure or intolerance of a 3-month trial of at least 2 conservative therapies (e.g., activity modification, weight loss, physical therapy, opioids, and anti-inflammatory medications, and injection of hyaluronic acid or steroids)
* Successful extraction of synovial fluid at Screening
* Negative pregnancy test at Screening and Baseline (subjects of childbearing potential \[SOCBP\])

Key Exclusion Criteria:

* Current or documented history of inflammatory arthritis (such as gout or rheumatoid arthritis), inflammation of connective tissue, or other immunological disease
* Any form of joint degeneration as part of another syndrome (e.g., Ehler's Danlos, Stickler syndrome, etc.)
* Surgery in the target knee within the 6 months prior to screening
* Previous partial or total joint replacement in target knee
* Significant and clinically evident malalignment of the target knee that would impact the subject's function, as determined by the Investigator
* Body mass index (BMI) \> 38 kg/m2
* Clinically significant abnormal laboratory values at Screening in laboratory parameters that in the opinion of the Investigator, could represent a potential risk to participant safety:
* Plans to have, elective surgery of other joints or spine or intra-articular injections in the target knee, within the next 12 months
The Sports-Related Injuries and Illnesses in Para-sport Study (SRIIPS)

The overall aim of this project is to gain an in-depth understanding of the epidemiology of sports-related injuries and illnesses in parasport in order to assist the identification and development of specific injury prevention strategies adapted to parasport.

The Paralympic Games is today one of the largest sport event in the world. During the last decades parasport has in many ways become elite sport, allowing people with disabilities to achieve extraordinary heights of functional capability. With the growing number of athletes there is an increased interest in athletes' health and safety, both to enhance sports performance and to prevent injuries.

Even though it is well-known that participation in sports places the athlete at risk for injuries, there are few studies covering sports-related injuries and illnesses in parasport (SRIIP). Today, some injuries and illnesses are known to be preventable. However, this requires regular monitoring of internal and external load during athletic preparation. Standardized injury surveillances have been implemented within several sports for abled-bodied athletes, but such studies do not yet exist within parasport.

In our review article (Fagher \& Lexell 2014) the investigators showed that existing studies of sports-related injuries in athletes with disabilities have a variable quality and that specific disability related factors have not been examined. Further studies are therefore warranted to obtain an increased in-depth knowledge of SRIIP. With a systematic longitudinal surveillance system tailored to parasport it would be possible to observe trends and risk factors over time, and thereby have a basis for developing specific preventive measures.

The overall aim of this project is to gain an in-depth understanding of the epidemiology of SRIIP in parasport in order to assist the identification and development of specific injury prevention strategies adapted to parasport.

The specific aims are: i) to design and implement a study protocol for prospective epidemiological studies of SRIIP in parasport; ii) to prospectively estimate the annual incidence of SRIIP among Swedish Paralympic athletes; and iii) to explore risk factors and mechanisms for sustaining SRIIP based on athlete exposure in order to form the basis for moving towards safe participation in parasport.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-55 years
* Being a registered competitive athlete within the Swedish Paralympic Program/Organization
* Being able to communicate in Swedish and having the opportunity to every week answer a web-based questionnaire.
Curcumin Associated With Thiopurin in the Prevention of Post-op Recurrence in Crohn Disease

Curcumin, the active ingredient of turmeric, has been used for long term in the treatment of inflammatory conditions. Inhibition of NF-κB is postulated as the main mechanism responsible for the anti-inflammatory effect of curcumin

Aim : to study the effect of curcumin, 3g per day, as compared to placebo, combined with thiopurines in the prevention of Crohn's disease post-operative recurrence.

122 subjects, operated on for Crohn disease, will be included in the study. After ileo-colonic resection, subjects will be randomized into two arms; they will be given either placebo or curcumin 3g/d per os plus thiopurines during 6 months in a double-blind manner. Rutggerts endoscopic score at 6 months will be the main judgment criteria.

Eligibility Criteria:
Inclusion Criteria:

* Crohn's disease confirmed by radiographic, endoscopic or histologic criteria
* Age \> 18 yr
* Affiliated to french health insurance
* Operated on less than 15 days ago for ileal, colonic or ileo-colonic Crohn's disease with all macroscopic lesions being removed, with an anastomosis which can be reached by ileocolonoscopy

Exclusion Criteria:

* Ulcerative colitis
* Pregnant or nursing woman
* Refusal of contraceptive measure for childbearing potential, woman or fertile man
* Indication of anti-TNFα treatment
* Concomitant treatment including antibiotics, probiotics, mesalazine, methotrexate, cyclosporine, tacrolimus, anti-TNFα, ustekinumab, vedolizumab
* Concomitant treatment with corticosteroids, except in case of tapering a treatment initiated before surgery
* Renal insufficiency ( serum creatinine 2N)
* Chronic hepatic disease except for primary sclerosing cholangitis
* ALAT , ASAT, alkaline phosphatases, or bilirubin \> 3N
* Current infection to HIV, HBV (except if HBV Ac positives), HCV
* Contraindication to thiopurines
* Unwillingness of the patient
Implementation & Dissemination of a Digital Health Intervention for Adolescent Sleep

The goal of this study is to form a Teen Advisory Board (TAB), who will partner with our study team to co-design a beta-test a new prototype of the Firefly program, a mobile-native insomnia cognitive behavioral therapy intervention for teens. This new prototype will have addressed issues that adolescents who had used the first version of the program deemed to be barriers to engaging with the treatment.

The aims of this study are to: 1) form a Teen Advisory Board (TAB) of teens with self-reported insomnia symptoms, 2) co-design a functional app prototype for sleep with TAB, 3) conduct two rounds of beta-testing to inform the iterative refinement of the app prototype. Participants will include 40 youth and their parents; 10 youth will participate in the TAB and first round 1 of beta-testing, and a separate cohort of 30 youth will participate in a second round of beta-testing. Youth will be ages 13-18 years and will have self-reported insomnia symptoms.

Eligibility Criteria:
Inclusion Criteria:

* 13-18 years old
* Self-reported insomnia symptoms

Exclusion Criteria:

* Non-English speaking
A Relevance Study Between the Result of Clinical Drug Intervention and Next-generation Sequencing Technology Focused on Refractory Helicobacter Pylori Infection

Approximately 50% of people in the world are infected with H. pylori, and its eradication rate fail to exceed 80% and even fails into an unacceptable range.Various risk factors for infection include lower socioeconomic status, younger age, and geographic location.In the present study, investigators aimed to perform a prevalence survey about risk factors for H. pylori infection.To obtain the higher eradication of H. pylori and find out the relevance between the diverse infection and clinical drug focused on refractory H. pylori infection.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18\~70 years old, male or female, untreated patients.
2. Symptoms of abdominal pain, bloating, acid reflux,belching,nausea,vomiting,heartburn, chest pain, vomiting, melena, etc.
3. Unused antibiotics, bismuth, H2 receptor antagonists or PPI by nearly 4 weeks
4. 13C-labelled urea breath test positive.
5. Agreed to Helicobacter pylori culture and sensitivity testing taken by endoscopy gastric biopsy specimens,and the result of culture was positive.
6. Agreed to Helicobacter pylori eradication therapy and cooperate with the eradication efficacy follow-up survey.

Exclusion Criteria:

1. Severe heart, liver, kidney dysfunction.
2. Pregnant or lactating women.
3. Complications of bleeding, perforation, pyloric obstruction, cancer.
4. Esophageal,gastrointestinal surgery history.
5. Patients can not properly express their complaints,such as psychosis, severe neurosis.
6. Taking NSIAD or alcohol abusers.
7. Allergic to penicillin or either drugs of the 6 antibiotic tested by susceptibility testing.
Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery

The purpose of this study is to test two different ways to help men with sexual rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* As per medical record, early stage prostate cancer (Pathologic Stage 1/2 with Gleason score \</=8; or Pathologic Stage 3 with Gleason score =/\< 7)
* As per medical record, radical prostatectomy (RP) conducted either at MSKCC or at another institution
* As per medical record, ≤ 9 months post-RP
* As per medical record, moderate erectile functioning pre-surgery (i.e., 15 or greater on the IIEF Erectile Function Domain (EFD) score, or graded their erections as a 1 or 2 on the standard 5 point Urology Erectile Function scale, or have a score of 6 or greater on the 1-10 pre-surgery erectile function scale on the SMRP assessment or have a total score of 15 or greater on items 2-7 on the Prostrate Quality of Life Survey: Sexual Domain)
* As per self report or as per medical record starting penile injections as part of the erectile rehabilitation program at MSKCC
* In the judgment of the consenting professional able to communicate, comprehend, and complete questionnaires in English

Exclusion Criteria:

* Both cavernous nerves fully resected as per surgery report (nerve sparing score of 8 in MSKCC surgeon note), or documented in the progress note that the nerves were fully resected.
* Currently on or has a history of being an Androgen Deprivation Therapy (ADT)
* Has any indication of Prostate-Specific Antigen (PSA)
* As per self report, specific injection phobia
* In the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessment.
* As per self report or as documented in the medical record, current untreated (e.g. no medication no therapy) major psychiatric disorder (schizophrenia, major depression). Patients diagnosed with a major psychiatric disorder will be reviewed by the study PI to determine eligibility prior to consent.
Efficacy of Olibra: A 12 Week Controlled Trial

Today's obesogenic environment, favors behavioral choices that lead to an excess of energy intake over expenditure, and consequently weight gain. Intervention strategies that harness the body's own appetite and satiety regulating signals could provide an effective means of countering excessive energy intake. The purpose of this study was to investigate whether a vegetable oil emulsion (Olibra) would result in weight loss that was associated with a reduction in food intake.

71 healthy subjects were enrolled (60 females, 11 males; Age: 18 - 60 years, BMI 25 - 40 kg/m2) in a two-phased, randomized, placebo-controlled, double-blind, parallel trial. During a 12-week period, Olibra was compared with a placebo (milk fat). Food intake testing was conducted on three days and anthropometric data was collected on 7 days. Key outcome measures were, body weight, body composition, energy intake, and appetite ratings.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects of both sexes 18 - 60 years of age
* body mass index (BMI) between 25 and 40 kg/m2, inclusive

Exclusion Criteria:

* (1) participation in another clinical trial or receipt of an investigational product 30 days prior to enrollment
* (2) a dietary restraint score of \> 13
* (3) weight loss of 4.5 kg or more in the preceding three months
* (4) use of tobacco products, nicotine gum or nicotine patch
* (5) a medical condition or taking regular medication except oral contraceptives and hormone replacement therapy
* (6) use of a nutritional product or dietary supplement or program which might interfere with the conduct of the study or place the subject at risk
* (7) history of alcohol or other drug abuse in the preceding one year
* (8) pregnancy, lactation, post-partum less than six months, planning a pregnancy during the study or not using an acceptable method of contraception
* (9) fasting blood sugar ≥ 126 mg/dl
* (10) known allergy or sensitivity to any ingredient in the supplement
* (11) clinically significant deviations in normal laboratory values
* (12) irregular meal-times, and
* (13) unwilling to eat yogurt at test meals.
Ketoconazole Contributes to Cryptorchidism Outcome Via Modulating Macrophage Trem2

Reduced hormone insulin-like 3, exclusively secreted by Leydig cells, has been identified as the recognized mechanism for cryptorchidism. Testicular macrophages residing in the testicular interstitium were thought to play a vital role in maintaining hormone secretion of Leydig cells. However, the contribution of macrophages to cryptorchidism remained poorly understood. Here, after 14 days of ketoconazole treatment, levels of both Trem2 and insulin-like 3 significantly decrease in human embryonic testes compared to the untreated control group. Conversely, 14 days of luteinizing hormone stimulation lead to elevated levels of Trem2 and insulin-like 3 in the testes compared to the untreated control group. Additionally, researchers find a positive correlation between Trem2 and insulin-like 3 expression in a human ex vivo tissue culture model. In summary, the study will propose Trem2 as a novel target for maintaining normal testicular descent by regulating the testicular immune microenvironment.


Eligibility Criteria:
Inclusion Criteria:

* 1. Termination of pregnancy is not related to the health of the fetus.
* 2. The fetus is intact in development and free of malformations and abnormalities.
* 3. Estimation of gestational age based on parietal-rump length must be between 8 and 13 weeks of gestation.

Exclusion Criteria:

* 1. The termination of pregnancy is related to the health of the fetus
* 2. The fetus is not intact in development.
* 3. The fetus has malformations, abnormalities
* 4. Estimation of gestational age based on parietal-rump length must not be within 8-13 weeks of gestation.
Multi-parametric Functional MRI in Patients of Chronic Kidney Disease

To explore the value of MR Fingerprinting-generated quantitative maps combined with ASL renal perfusion imaging in the assessment of renal impairment in chronic kidney disease.

Chronic kidney disease (CKD) has become an important public health problem threatening human health worldwide. The prevalence rate of CKD in Chinese adults is 10.8%, but the awareness rate and diagnosis rate are generally low. At present, the assessment of renal impairment in CKD mainly relies on laboratory tests, such as estimated glomerular filtration rate (eGFR) and urinary protein/creatinine ratio, and the value of functional MRI in the assessment of renal impairment in patients with CKD is unclear. As a new sequence still in the scientific research stage, MR Fingerprinting can simultaneously generate quantitative T1 maps, T2 maps and proton-weighted images in one breath holding scan, with short scanning time, high repeatability and accuracy. It has been proved that quantitative techniques of T1 mapping and T2 mapping are valuable for evaluating the degree of renal fibrosis and water content. Kidney is a blood-rich organ, and the blood flow of kidney is of great significance to the evaluation of renal function. ASL uses hydrogen protons in arterial blood as an endogenous tracer to evaluate tissue blood perfusion, and can quantitatively evaluate renal blood perfusion in patients with CKD without the use of exogenous contrast agents, avoiding the risk of aggravated renal damage and nephrogenic fibrosis caused by injection of gadoline-containing contrast agents. The objective of our study was to explore the value of MRF sequence-generated quantitative maps combined with ASL renal perfusion imaging in the assessment of renal impairment in chronic kidney disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with chronic kidney disease (CKD) by renal biopsy

Exclusion Criteria:

* Patients with serious underlying diseases
* Patients with MRI incompatible metal implants and contraindications such as claustrophobia
* Patients with imperfect clinical data and pathological data
Real-Time Assessment of Lung Structure and Function in Children and Young Adults With CF Using Electrical Impedance Tomography

The purpose of this study is to determine the ability of electrical impedance tomography (EIT) to identify structural and functional physiological changes that occur with disease progression in cystic fibrosis patients. The investigators also aim to determine whether EIT can serve as an alternative for CT to identify regions of air trapping and consolidation, whether EIT can provide clinically useful information about response to treatment for an acute PE, and whether EIT can provide longitudinal information about structural changes in the lung.


Eligibility Criteria:
Inclusion Criteria:

Cohort 1:

* Age 3-21 years
* Male or female
* Healthy subjects with no known or suspected chronic or temporary lung disease

Cohort 2:

* Age 3-21 years
* Male or female
* CF as diagnosed based on sweat chloride value(\>60 mmol/L) or two known disease causing mutations

Cohort 3:

* Age 3-21 years
* Male or female
* CF as diagnosed based on sweat chloride value (\>60 mmol/L) or two known disease causing mutations
* Experiencing a protocol defined pulmonary exacerbation and being started on oral or intravenous antibiotics

Exclusion Criteria:

* Unwilling/refusal to sign consent
* Known congenital heart disease, arrhythmia, or history of heart failure
* Wearing a pacemaker or a metallic surgical implant in the chest
* History of infection with Burkholderia cepacia
* Developmental delays that could result in an inability to complete study procedures