cyrilzakka/clinical-trials huggingface dataset:
Effect of GH on the Blastocyst Euploid Rate in AMA Patients

This randomized trial aims to compare the euploid rate of blastocysts in AMA patients undergoing PGT-A (preimplantation genetic testing for aneuploidy) with or without growth hormone supplement.

Infertile patients ≥38 years old will be recruited for study after informed consent if they fulfill the inclusion criteria and do not have the exclusion criteria. Eligible women will be randomised into one of the two groups:

Treatment group: Women will receive growth hormone (GH) supplement before and during antagonist protocol for ovarian stimulation.

Control group: Women will receive antagonist protocol for ovarian stimulation. The primary outcome is the euploidy rate of blastocysts.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥38; intended to undergo PGT-A
* BMI in the normal range (18.50-24.0kg/m2)
* Normal semen analysis for the male partner

Exclusion Criteria:

* Endometriosis grade 3 or higher, untreat hydrosalpinx
* Women with a uterine cavity abnormality, such as a uterine congenital malformation (uterus uni-cornate, bicornate, or duplex); untreated uterine septum, adenomyosis, submucous myoma, or endo-metrial polyp(s)
* Women who are indicated and planned to undergo PGT-SR (Preimplantation genetic testing for structural rearrangement) or PGT-M (Preimplantation genetic testing for monogenic disorder), for example, parental abnormal karyo-type or diagnosed with monogenic disease
* History of endocrine disorder, autoimmune diseases or diagnosed thrombophilia
* History of GH supplementation in the previous IVF treatment or taking other supplementary drugs used during stimulation; patients with absolute or relative contraindications to GH treatment, including active malignancy or history of cancer, diabetic retinopathy, diabetes mellitus, and chronic kidney disease.
Helicobacter Pylori Eradication Study in Parkinson's Disease

It has been hypothesized, based on epidemiological observations, that Helicobacter pylori (HP) infection may play a role in the pathogenesis of Parkinson's Disease (PD). Previous studies have also shown that HP eradication therapy may result in improvements in levodopa pharmacokinetics and motor fluctuations. This study aims to examine the effects of HP eradication, using a double-blind randomized placebo-controlled trial design in a relatively large cohort of patients. Outcomes of interest include motor function, gastrointestinal symptoms and health-related quality of life. The investigators hypothesize that HP eradication will lead to improvements in motor function. The primary outcome of interest is the "ON"-medication Unified PD Rating Scale (UPDRS) Part III score at 3 months. Secondary outcomes include Purdue Pegboard Score, Timed Test of Gait, Dyskinesia and Bradykinesia scores measured by Parkinson's Kinetigraph (PKG), Leeds Dyspepsia Questionnaire (LDQ), Parkinson's Disease Questionnaire (PDQ-39), UPDRS Part I, Part II and Part IV; and Montreal Cognitive Assessment (MOCA).


Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥18 years
2. Provision of written informed consent
3. Clinical diagnosis of Parkinson's Disease (PD) assigned by a consultant neurologist

Exclusion Criteria:

1. History of previous gastric or major abdominal/pelvic surgery
2. History of previous eradication therapy for Helicobacter pylori
3. Antibiotic use in the preceding four weeks or use of anti-acid/prokinetics/laxatives in the preceding one week prior to breath test
4. Recent initiation of dopaminergic medications (within the last three months) or recent adjustment of dopaminergic medications (within the last one month)
5. History of functional neurosurgery for PD
6. No concomitant neurologic disease except PD
7. Medical condition that prevents reliable completion of questionnaire
CRTd Responders Optimization

Suboptimal optimization of atrio-ventricular (AV) and inter-ventricular (VV) timings could affect the clinical response of CRTd in T2DM patients. Thus, authors hypothesize that automatic sensor guided CRTd optimization could ameliorate clinical outcomes in patients with T2DM. However, authors will evaluate the effects of cardiac resynchronization therapy (CRTd) in patients with type 2 diabetes mellitus (T2DM) optimized via automatic vs. echocardiographic guided approach.Authors will conduct a prospective, multicenter study to recruit, from October 2016 to June 2019, patients with T2DM and heart failure (HF) candidate to receive a CRTd. After CRTd the patients will be optimized via automatic vs. echocardiographic guided approach.


Eligibility Criteria:
Inclusion Criteria:

* heart failure with reduced cardiac pump, NYHA class II/III, indication to receive a CRTd.

Exclusion Criteria:

* NYHA class IV, previous CRTD implantation, neoplastic disease, inflammatory chronic disease.
Comparison Between Endogenous and Exogenous Ketosis in Patients With Non-ischemic Chronic Heart Failure With Reduced Ejection Fraction

This randomized controlled trial will evaluate the effect of a ketogenic diet and/or exogenous administration of ketone bodies vs conventional diet on the ejection fraction of patients with non-ischemic chronic heart failure, measuring MRI biomarkers.

Evidence in both animals and humans suggests ketosis could be beneficial for people living with chronic heart failure. To date, no study has compared endogenous vs exogenous ketosis in patients with chronic heart failure. We will randomize (with a 1:1:1 ratio) patients with a confirmed diagnosis of non-ischemic chronic heart failure to undergo one of the following:

1. - A ketogenic diet (\<50 gr of carbohydrates per day) incorporating current recommendations for heart failure (low sodium and liquids) for 10 days.
2. - Standard diet incorporating current recommendations for heart failure (low sodium and liquids) and supplementation with exogenous ketones (ketone monoester) for 10 days.
3. - Standard diet incorporating current recommendations for heart failure (low sodium and liquids) and supplementation with bitter taste placebo.

The endpoints will be assessed using cardiac MRI and blood biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Ejection fraction \<40% minimum 1 month.
* No change in optimum treatment 1 month at least.

Exclusion Criteria:

* Ischemic cardiopathy (Angio-tomography corroborated cut-point \>50% obstruction, coronary angiography, or cardiac scintigraphy 6 months at least) or angina pectoris symptoms.
* Reynaud syndrome
* Metformin or SGLT-2 Inhibitors treatment, Low BMI, nutritional deficiencies.
* Creatinin clearance \<30ml/min or renal replacement therapy
* MRI contraindications (prothesis, Unsupported pacemakers, claustrophobia, etc)
* Reynaud phenomenon history
Intralesional 5-fluorouracil Injection for the Treatment of Oral Leukoplakia

This is a single center, open-label, interventional pilot study to assess the feasibility, safety, and preliminary efficacy of intralesional 5-FU injections for the treatment of oral leukoplakia (OL).

PRIMARY OBJECTIVE:

I. Evaluate the feasibility of intralesional 5-fluorouracil (5-FU) injection for the treatment of oral leukoplakia

SECONDARY OBJECTIVE:

I. Evaluate the safety profile and side effects of the study drug.

OUTLINE:

Participants diagnosed with OL will receive multiple intralesional injections of 5-FU solution over a maximum period of 6 weeks, followed by a follow-up visit after 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Adults, 18 years of age or older
* Any gender, race, or ethnicity
* Clinical diagnosis of oral leukoplakia and biopsy proven dysplasia (any grade)
* Oral leukoplakia at least 1 cm in largest diameter
* Ability to understand and willingness to sign a written informed consent document
* Willingness to provide blood and tissue from diagnostic biopsies
* Any smoking history is permitted

Exclusion Criteria:

* Pregnant or lactating women
* Men and women unwilling to use contraception while on study
* History of malignancy that required cytotoxic chemotherapy within the previous 3 months
* Use of 5-FU (systemic or topical) within 3 months prior to study enrollment
* History of allergic reaction or severe hypersensitivity to 5-FU and/or lidocaine
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Evaluation Of The Efficacy Of The Combination Of Axitinib With Pemetrexed And Cisplatin In The Treatment Of Non-Squamous Non-Small Cell Lung Cancer

AG-013736 (axitinib) in combination with cisplatin and pemetrexed will be evaluated as first-line treatment of patients with locally advanced, recurrent, or metastatic non-squamous, non small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of adeno-, large cell or bronchioalveolar non-small cell lung cancer
* Cytologic specimens for diagnosis or for cell type classification must have been obtained from bronchial brushings or washings or from needle aspiration of a defined lesion. Sputum cytology alone will not be acceptable for diagnosis or for cell type classification.
* Patients with mixed NSCLC with predominantly squamous cell carcinoma should be classified as squamous and thus do not qualify for this study.
* Stage IIIB with malignant effusion (with cytologic confirmation of malignant pleural or pericardial effusion), Stage IV, or recurrent disease after definitive loco-regional therapy.
* Candidate for primary treatment with cisplatin and pemetrexed

Exclusion Criteria:

* Any histological/cytological evidence of predominantly squamous NSCLC.
* Small cell or carcinoid lung cancer patients are also ineligible.
* NSCLC that cannot be classified as one of the eligible histologies (adenocarcinoma, large cell or bronchioalveolar).
* Prior systemic therapy for Stage IIIB (with malignant effusion), Stage IV, or recurrent NSCLC. (Prior treatment with systemic therapy as adjuvant chemotherapy or in conjunction with radiotherapy for Stage II or III NSCLC is permitted if the last dose of chemotherapy was completed 12 months or more prior to randomization).
* Prior treatment with a VEGF or VEGFR inhibitor.
Robot Coach of Chronic Low Back Pain Patient

The objective of KERAAL technological project is to create a new intelligent robot which allows a humanoid robot to record then to show and to follow the progress of rehabilitation sessions proposed by a physiotherapist to a patient, the latter being able to practice without the physiotherapist. The final objective is to stimulate and increase the overseen time of rehabilitation. Poppy robot was chosen as it is able to realize all kind of movements notably movements of the spine with 5 degrees of freedom associated to the several levels of the spine. It will allow to address the population included in the protocol. RCOOL study tries to validate this prototype device as tool of rehabilitation.

The main objective is the feasibility of the supervision by a humanoid robot of a succession of rehabilitation exercises.

RCOOL study is a randomized clinical trial checked under single-blind condition to compare two rehabilitation strategies, one with exercises executed by the patients and supervised by Poppy and the other one with usual rehabilitation protocol.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Low back pain (more than 6 months)
* Patient who has completed an outpatient rehabilitation program with at least 20 spine-centric sessions
* Inclusion in a low back pain rehabilitation program in an inpatient our outpatient unit.
* Adult between 18 and 70 years old
* Patient affiliated to French social security system
* Patient having signed an informed consent of participation for research

Exclusion Criteria:

* Symptomatic low back pain (identified medical etiology)
* Isolated sciatica, whatever the cause
* Cruralgia
* Chronic widespread pain
* Age lower than 18 and higher than 70
* Unfit of agreeing or refusing to participate in the study
* Unstable medical situation preventing the continuous realization of a program of at least 4 weeks
TRIAD - Treatment of Insomnia and Depression

The aim of the proposed three-site study is to increase the rate of full remission from major depressive disorder (MDD) at the end of 16 weeks of treatment for people who experience both major depressive disorder and insomnia.

Participants with major depressive disorder and insomnia who meet all study criteria will receive state-of-the-art antidepressant medications and one of two insomnia therapies. The specific therapy for insomnia will be determined by chance (like a flip of a coin), with an equal chance to receive either cognitive-behavioral therapy for insomnia or desensitization psychotherapy for insomnia. The study physician will select an initial antidepressant medication from a list of three possible medications . If that medication is not helpful, another medication may be tried after 8 weeks or in the event of severe side effects.

Eligibility Criteria:
Inclusion Criteria:

1. Meets criteria for Major Depressive Disorder
2. Between 18 and 75 years of age and adequately fluent in English
3. Meets criteria for an insomnia disorder

Exclusion Criteria:

1. Women who are currently pregnant, breast-feeding, or not using a reliable birth control method.
2. People for whom the antidepressant medication(s) provided in the study is not indicated
3. People who have had minimum adequate trials of (or have not been able to tolerate) all three study medications.
4. People with uncontrolled medical conditions.
5. People with moderate or severe sleep disorders other than insomnia
6. Individuals on a fixed night shift or rotating work schedule that requires a night shift.
7. Patients with a current principal diagnosis of a psychiatric disorder that necessitates treatment that is not offered in the study.
Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France: Trial IMEA 055 - FAST

Evaluation of antiretroviral treatment adherence using determination of Bictegravir, Emtricitabine and Tenofovir with new HIV patients in France

* Patient treated at the first clinical contact
* 18 sites (hospitals) in France
* Treatment during 48 weeks with principal objective at W24 (plasma HIV-RNA \< 50 copies/ml)
* Evaluation of antiretroviral treatment adherence using determination of Bictegravir, Emtricitabine and Tenofovir in hair sample

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* newly diagnosed HIV-infected individual evidenced by any of the following tests: (i) positive self-test, (ii) positive HIV Rapid antibody test, (iii) positive HIV immunoassay (ELISA 4th generation) test
* antiretroviral-treatment naive
* negative urine pregnancy test for women of childbearing potential and willing to use effective contraception (mechanical or medicamental)
* willing to sign an informed written consent-
* regular health insurance
* willing to provide two distinct contact information (telephone number and/or email) in order to be easily reached if needed between Day 0 and Day 7

Exclusion Criteria:

* clinical symptoms suggestive of opportunistic infections
* participant not willing to provide two distinct contact information
* a woman who is pregnant or breast-feeding or planning to become pregnant during the expected study period.
* Co-medication with deleterious interaction with study treatment (eg enzyme inducer)
Fetal Neurobehavior in Poly-drug Dependent Women

This project examines fetal neurobehavior and maternal physiology in poly-drug dependent women. This study also evaluates infant neonatal abstinence syndrome, infant neurobehavior and vagal tone in the post-partum period.

Little is known about the link between maternal physiology, fetal neurobehavior and neonatal abstinence syndrome in multiply drug-dependent women. Previous research by this group of investigators has found that the severity of neonatal abstinence syndrome in methadone exposed infants is related to maternal vagal tone changes in response to methadone during pregnancy. While previous research has focused on drug abstinent, methadone maintained women, most drug dependent pregnant women are poly-substance abusers who also use prescription psychiatric medications, alcohol and nicotine. This protocol seeks to further our understanding of the effects of multiple drugs on the fetus, including the co-variate effects of maternal psychological status. Infant neurobehavior and vagal tone will also be evaluated. This research will extend our knowledge of fetal neurobehavioral development and neonatal abstinence syndrome in a realistic population of poly-drug dependent women, potentially altering the way in which these women are evaluated and their infants monitored and treated for neonatal abstinence syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-41
* Single intrauterine fetus
* Free of significant maternal or fetal significant health complications

Exclusion Criteria:

* Development of significant maternal or fetal health complications
* Significant maternal psychopathology that would preclude informed consent
* Unwilling or unable to receive methadone at prescribed times
China Refractory Obsessive-Compulsive Disorder Deep Brain Stimulation Study

Refractory obsessive-compulsive disorder (OCD) is a disabling condition. Deep brain stimulation (DBS) of the nucleus accumbens is the most tested therapeutic avenue for refractory OCD. However, large scale randomized controlled trials to evaluate the effectiveness of this approach are rare.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 60 years.
2. A primary diagnosis of OCD, defined according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV).
3. Chronic: disease duration of more than 5 years.
4. Severity: a score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) of more than 25 or one subscale score of more than 15 ; a score for severity of illness on the Clinical Global Impression (CGI) scale of more than 4.
5. Disability: a score on the Global Assessment Functioning (GAF) scale of less than 45.
6. Refractory: a lack of response to drug therapy after adequate administration (defined as more than 12 weeks at the maximum tolerated dose) of at least three serotonin-reuptake inhibitors, one of which had to be clomipramine. Adequate behavior therapy, defined as 20 sessions of exposure and response prevention (ERP) with a therapist who has substantial expertise in OCD treatment.

Exclusion Criteria:

1. Schizophrenic disorder; bipolar disorder; substance abuse or dependence (except for dependence on nicotine), as assessed with the use of the Mini-International Neuropsychiatric Interview (MINI 6.0.0).
2. Cluster A or B personality disorder according to DSM-IV criteria, as assessed with the use of the Structured Clinical Interview II.
3. A current severe major depressive episode, determined according to DSM-IV criteria (as assessed with the use of the MINI 6.0.0) and defined by the Hamilton Depression Rating Scale-17 (HAMD) score of more than 20 and a risk of suicide.
4. Abnormal cognitive status (measured by MoCA), abnormal findings on functional magnetic resonance imaging (MRI) of the brain; and no contraindications to surgery or anesthesia.
Impact of Beta-blockers on Physical Function in HFpEF

The purpose of this study is to understand the impact of beta-blockers on physical function in older adults with heart failure. We will achieve this objective by conducting N-of-1 trials. N-of-1 trials are personalized experiments that test different treatment options in an individual patient.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory adults ≥65 years of age with Heart Failure with Preserved Ejection Fraction (HFpEF) according to ACC/AHA guidelines: (signs and symptoms of Heart failure \[HF\] and ejection fraction \[EF\] ≥50%)
* Taking Beta blocker

Exclusion Criteria:

* Alternate Causes of HFpEF Syndrome:

  1. Severe valvular disease
  2. Constrictive pericarditis
  3. High output heart failure
  4. Infiltrative cardiomyopathy
* Other compelling indication for beta blocker

  1. Prior EF \< 50%
  2. Hypertrophic cardiomyopathy
  3. Angina symptoms
  4. Acute coronary syndrome, myocardial infarction or coronary artery bypass surgery in prior 3 year
  5. History of ventricular tachycardia
  6. Atrial arrhythmia with hospitalization for rapid ventricular response, prior 1 year
  7. Sinus tachycardia \> 100 beats per minute (bpm), atrial arrhythmia with ventricular rate \>90 bpm, systolic blood pressure \> 160 mmHg
* Clinical instability (N-of-1 trials are appropriate for stable conditions only)

  1. Decompensated HF
  2. Hospitalized in past 30 days
  3. Medication changes or procedures in prior 14 days (to prevent confounding from other interventions), at PI discretion
* Estimated life expectancy \<6 months
* Moderate-severe dementia or psychiatric disorder precluding informed consent
* Any condition that, in Principal Investigator's opinion, makes the patient unsuitable for study participation
Role of Post Surgery CT Following Laparoscopic Vertical Sleeve Gastrectomy

Obesity is a extremely widespread condition in Europe and North America, burdened by a series of complications characterized by major morbidity and morbility. In recent years, bariatric surgery has progressively assumed a leading role in the treatment of morbid obesity and restrictive bariatric surgery procedures, such as laparoscopic vertical sleeve gastrectomy are common.

The aim of the study is to retrospectively determine the value of postoperative CT after LSG as an early tool to identify risk factors for the subsequent development of gastric fistula and enable to stratify postoperative risk in asymptomatic patients and ensure effective management of these risk factors.


Eligibility Criteria:
Inclusion Criteria:

* adult obese patients with LSG
* BMI ≥ 40 kg/m2 or BMI between 35 and 40 kg/m2
* evidence of obesity related comorbidity
* availability of upper abdomen CT scan with IV and oral contrast medium within 72 hours of surgery

Exclusion Criteria:

* Pregnant women
* allergy to contract medium
* lack of venous access
* patients who did not have a post-surgical upper abdomen CT
Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps

The goal of this study is to evaluate the effectiveness of magnesium supplements (MagTabSR 168 mgs twice daily) for relief and/or improvement in the frequency, duration, and intensity of chronic leg cramps. Improvement in sleep disturbances and quality of life will also be evaluated.

Chronic leg cramps are prevalent among the aging population affecting sleep patterns and quality of life. Magnesium deficiency may cause muscle weakness and cramps. Magnesium supplementation will be evaluated for the relief and/or improvement of symptoms. The primary objective is to evaluate the efficacy of magnesium supplementation, MagTabSR, 168mg's twice a day, for the relief and/or improvement in the frequency, duration, intensity of leg cramps. Secondary objectives are to evaluate the improvement in sleep disturbances and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* 40-85 Years Old
* No Kidney Impairment
* 2 or more leg cramps per week for last 30 days

Exclusion Criteria:

* \< 40 or \> 85 Years Old
* Kidney Impairment
* \< 2 leg cramps per week for last 30 days
* Enrolled in another research study
* History of seizure disorder
* Current treatment with Lithium
* Malabsorption or major intestinal disorders
* Significantly elevated magnesium level
* History of allergy to magnesium compound
* Use of Quinine for leg cramps
* History of significant diarrhea
* History of drug or alcohol abuse in the last 2 years
* Currently diagnosed with a terminal illness