cyrilzakka/clinical-trials huggingface dataset:
Trial Comparing Start Stimulation of Recombinant Follicle Stimulating Hormone (rFSH) on Cycle Day 2 Versus Cycle Day 5 in In Vitro Fertilization (IVF)

Background of the study:

Milder stimulation protocols have the advantage of being less expensive and more patient-friendly. Moreover, recent evidence suggests that mild stimulation protocols lead to lower embryo aneuploidy rates compared to conventional treatment regimens. Although with mild stimulation protocols the expected number of oocytes retrieved will be lower, pregnancy rates have shown to be similar possibly because embryo quality outfavours embryo quantity.

Objective of the study:

The aim of the study is to determine whether cycle day (CD) 5 start of stimulation will lead to better quality of embryos, based on morphology, than CD 2 start, in IVF with GnRH antagonist co-treatment started on a fixed day.

Study design:

Prospective randomized trial comparing two different starting days of ovarium stimulation (day 2 versus day 5) for IVF treatment.

Intervention:

One group wil start on cycle day 2 with stimulation of the ovaries with recombinant FSH. The other group will start on cycle day 5. Both group will start suppressing the gonadotrophin production of the the pituitary gland on cycle day 6 with a GnRH antagonist.

Primary study parameters/outcome of the study:

Primary outcome parameter is number of top embryos per ovum pick up.

Secondary study parameters/outcome of the study:

Secondary outcome measures are duration of stimulation, cancellation rate, fertilization rate, number of cumulus oocyte complexes obtained, number of mature oocytes obtained, number of top embryos per started cycle, amount of IU recFSH, and clinical pregnancy rate.


Eligibility Criteria:
Inclusion Criteria:

* Female age \< 36 years
* FSH \< 12 IU/l
* BMI 18-29 kg/m2
* Regular cycle (25-35 days)
* No major uterine or ovarian abnormalities
* No previous IVF cycles
* Written informed consent

Exclusion Criteria:

* Oocyte donation
* Medical contra indication for pregnancy or IVF treatment
* Endometriosis ≥ grade 3
* Polycystic Ovarium Syndrome (PCOS)
* Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)
App-Based Mindfulness Training for Individuals With Anorexia Nervosa and Bulimia Nervosa

We will evaluate the acceptability and feasibility of a 8-week long digital mindfulness-based intervention for anorexia nervosa and bulimia nervosa.

This study is a prospective single-arm trial during the intervention development phase. Following this phase, after the intervention has been further developed, a subsequent study (with a different clinicaltrials.gov identification #) will utilize a randomized control trial design.

Procedures include completing: (1) pre-intervention screening assessment; (2) brief daily assessments for the first and last weeks of the study (4 times per day); (3) an initial baseline visit; (4) 8-week web-based intervention (3) a post-intervention assessment (8-weeks after baseline); and (4) a brief 8-week follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Can read and write in English
* Meet diagnostic DSM 5 diagnostic criteria for anorexia nervosa, bulimia nervosa, or atypical anorexia nervosa/bulimia nervosa
* Owns a smartphone
* Willing and able to participate in an eight-week long research study
* Have a private quiet space at home or headphones to complete modules
* Completed one month or more of eating disorder treatment
* Currently enrolled in eating disorder treatment

Exclusion Criteria:

* Fail to meet above-listed inclusion criteria
* Current alcohol or drug dependence
* Current untreated psychotic or bipolar disorder
* Current suicidal intent
* Significant cognitive impairment that would impair the ability to use Mindful Courage effectively
* BMI \<15 or medically unstable
* Currently receiving residential/inpatient treatment
Study to Evalutate Long-term Immunity of Hantavax in High Risk Population of HFRS

This study was aimed evaluate long-term immunity response by neutralizing antibody test of adults in high risk population of HFRS .

This clinical trial was designed as a multicenter, non-comparable, open-label clinical trial.This trial was conducted written informed consent form by voluntary agreement, negative result of hantaanvirus antubidy by neutralizaing antibody test, test drug was administrated 0, 1, 13 months according to drug label.

For antibody test, Sampling was conducted pre-dose(T0), 1 month after vaccination(T1), 1 year after vaccination(before booster vaccination, T2) and 1 month after vaccination(T3). Also, 1 month after vaccination (T3) after completion of booster vaccination for antibody retension duration observed for subjects with antibody to conduct a three-year follow-up survey was conducted, and the antibody test every year.In conclusion, sampling was conducted 12 months(T4), 24 months(T5), 36months(T6) after the booster vaccionation.

However, follow-up survey was terminated when the antibody titer was determined as a negative by neutralizing antibody test and fluorescent antibody technique.

Eligibility Criteria:
Inclusion Criteria:

* The subjects who have the vaccination history of ah the time of screening
* The subjects whose Hantaan virus virus's antibody shows negative using Neutralizing antibody test at the time of screening

Exclusion Criteria:

* The subjects who have a history of hemorrhagic fever with renal syndrome
* The subjects who have a fever or significant dystrophy
Head-down Position for Acute Ischemic Stroke With Large Artery Atherosclerosis

Currently, the guideline recommended re-perfusion such as intravenous thrombolysis and mechanical thrombectomy as the most effective treatment for acute ischemic stroke. However, the two methods are restricted by a strict time window, which greatly limits the number of the patients receiving treatment. The abundant studies have suggested that good collateral circulation can provide compensatory blood supply to save the ischemic penumbra and reduces the infarct volume, which improves the prognosis. How to improve collateral circulation in an efficient and safe way is a clinical challenge. Our recent experiment results of the animal and preliminary clinical experiments show that head-down position may significantly increase cerebral perfusion and improve neurological function. Clinically, head-down position is simple and easy to operate, and theoretically may increases brain perfusion and improve collateral circulation. A pilot randomized clinical trial is designed to investigate the effect of head-down position combined with routine rehabilitation in patients with ischemic stroke.The study is designed to explore the efficacy and safety of head-down position in patients with acute ischemic stroke


Eligibility Criteria:
Inclusion Criteria:

1. Patient age over 18 years
2. acute ischemic stroke within 24 h of onset
3. neurological deficit: 6≤NIHSS≤16
4. Large artery atherosclerosis etiology based on TOAST typing
5. the supplied vessel is the middle cerebral artery or internal carotid artery, and the degree of stenosis was more than 50%.
6. first stroke onset or past stroke without obvious neurological deficit (mRS≤1)
7. Signed informed consent

Exclusion Criteria:

1. Disturbance of consciousness
2. Hemorrhagic stroke or mixed stroke
3. Combining with severe organ dysfunction
4. Past hemorrhagic stroke
5. A history of stroke with severe sequelae
6. Planned revascularization within 3 months
7. Ischemic stroke due to surgical intervention
8. participating in other clinical trials within 3 months
9. Pregnant or lactating women
10. any inappropriate patient assessed by the researcher
Cognitive-behavioral Weight Loss Treatment

That a treatment using a cognitive-behavioral treatment for exercise and nutrition support will be associated with greater weight loss that a treatment of nutrition and exercise education.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Ages 21-60
* Body mass index 30-40 kg/m2

Exclusion Criteria:

* Pregnancy
* Medications for a psychological disorder
* Contraindications for exercise
First-in-man Study of Titanium-Nitride Coated Woven-nitinol Peripheral Arterial Stent

The GoldenFlow (Lifetech Scientific, Shenzhen, China) is a novel woven-nitinol stent designed to have superior radial strength, flexibility and durability compared to standard nitinol stents for femoropopliteal lesions. This is a first-in-man study to evaluate the safety and efficacy of GoldenFlow woven-nitinol stent for intraluminal treatment of peripheral vascular disease in the femoropopliteal arteries.

Endovascular treatment in femoropopliteal segment is the most challenging area due to restenosis and stent fracture after endovascular treatment. The titanium-nitride coated woven-nitinol peripheral arterial stent system (GoldenFlow, Lifetech Science, Shenzhen, China) is designed to have superior radial strength, flexibility and durability to withstand the compression, torsion, bending, lengthening and shortening found in femoropopliteal disease. Compared to another commercially available woven-nitinol stent, the GoldenFlow stent has the potential advantage to be repositionable and is less likely to lengthen during deployment. This is a first-in-man study is to evaluate the safety and efficacy of GoldenFlow woven-nitinol stent for intraluminal treatment of peripheral vascular disease in de-novo femoropopliteal lesions.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Symptomatic leg ischemia (Rutherford class 2 to 4)
3. Ankle Brachial Index \<0.9
4. De novo femoropopliteal stenosis (≥70%) or occlusion
5. Reference diameter 4 and 7mm
6. Lesion length 4 to 15cm
7. At least one patent (\<50% stenosis) infrapopliteal run-off vessel
8. The lesion(s) can be successfully crossed with a guidewire and dilated
9. Patients with bilateral femoropopliteal disease is eligible for enrollment into the study

   - Staged contralateral limb procedure can be performed \>30 days after index procedure
10. Able to provide written informed consent and willing to comply with specified follow-up evaluation schedule

Exclusion Criteria:

1. Tissue loss or gangrene (Rutherford class 5 and 6)
2. Previous bypass surgery or stenting in target vessel
3. Untreated aortoiliac or common femoral artery inflow disease \>50%
4. Intervention of ipsilateral lesions during the index procedure or staged intervention within 30 days after index procedure
Investigation of the Effects of External Electrical Stimulation in Women With Vaginal Laxity

The aim of this study was to investigate the effects of external electrical stimulation on clinical symptoms such as vaginal symptoms, pelvic floor symptoms, sexual function, pelvic floor muscle morphometry (levator ani thickness) and functions (strength, endurance), vaginal wall thickness and perception of healing in women with vaginal laxity.


Eligibility Criteria:
Inclusion Criteria:Complaining of vaginal laxity To be between 18-60 years old, Being sexually active, Volunteering to participate in the study, Becoming literate -

Exclusion Criteria:

Sensory loss Presence of infection Having a pacemaker Metal implant presence Malignancy story Having serious cardiovascular problems Presence of severe pelvic organ prolapse (above stage 2) Having undergone surgery for POP/incontinence (within the last 1 year) Pregnancy presence Having enough laxity to require surgery Having a neurological disorder Receiving estrogen therapy

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Exploratory Study of Natural Killer Cells in Human Skin

Natural Killer (NK) cells play a unique role during innate immune responses as they are able to recognize and eliminate, without specific sensitization, tumors, microbe-infected cells as well as allogeneic cells.In a first time, we will characterize the tissue distribution, the phenotype and the effector functions of NK cells present in the human healthy skin.

Then, we will define whether these parameters are qualitatively/ quantitatively modified in the following skin pathologies: a) atopic dermatitis; b) contact dermatitis; c) psoriasis ; d) lichen planus ; e) GVH (graft versus host disease) ; (f) melanoma.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Consent obtained after healthy donor or patient information.
* Patients suffering from one of the following diseases: a) atopic dermatitis ; b) contact dermatitis; c) psoriasis ; d) lichen planus ; e) GVH ; f) melanoma.

Exclusion Criteria:

* Age below 18,
* pregnant or breastfeeding women,
* persons under guardianship, persons without social security, prisoners, persons hospitalized without consent on the basis of French laws L. 3212-1 et L. 3213-1. Patients affected by HIV infection, AIDS, Hepatitis A, B or C infection.
* Neutropenia \<1000/mm3.
* Thrombopenia \<50 000/mm3.
Evaluation of Crestor® (Rosuvastatin) in Daily Practice

This open label, non-interventional study is to show the efficacy of Crestor (rosuvastatin) in reduction of LDL-cholesterol and cardiovascular risk parameters in patients with hypercholesterolemia. Effectiveness is to be evaluated using the difference in LDL cholesterol level between the first and the second visit after 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* a patient with hypercholesterolemia who has been prescribed Crestoraccording to physician's judgement, irrespective of the inclusion in the study.
* no treatment with any statin in the last 3 months

Exclusion Criteria:

* hypersensitivity to rosuvastatin or any other ingredient of Crestor
* active liver disease, severe renal insufficiency
* myopathy or predisposing risk factors for myopathy/ rhabdomyolysis
* woman of child-bearing potential and not using appropriate contraceptive measures, pregnancy or lactation
Effect of Amino Acid on Muscle Damage

The primary objective is to determine the impact of essential amino acids on integrated muscle protein synthesis over 4 days after resistance exercise.

In addition, the secondary objective is to determine the effect of essential amino acids on satellite cell regulation and inflammatory responses during this prolonged recovery period.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, male, recreationally-active participants
* Healthy will be defined as screened by the PAR-Q+ (The Physical Activity Readiness Questionnaire for everyone; Appendix. B). Active will be defined as being in the top 20% of age specific scores on iPAQ (the International Physical Activity Questionnaire; Appendix.C).
* Participants are required not to engage in lower limb RT (resistance training) for at least 6 months prior to the study.
* Participants will be 18-35 years old.
* Participants are willing to abide by the compliance rules of this study

Exclusion Criteria:

* Female
* Inability to adhere to any of the compliance rules judged by principle investigator or medical doctor
* Self-reported regular tobacco use
* Self-reported illicit drug use (e.g. growth hormone, testosterone, etc.)
* The individual who has allergy for milk
Validation of a Kinetic Model of Erlotinib

Several arguments are in favor of a therapeutic monitoring for the erlotinib, therefore, a pharmacokinetic (PK) has been prepared using data from the literature. This model must be validated at concentrations achieved in practice. This is a preliminary study before the implementation of a randomized trial confirming the therapeutic monitoring of erlotinib through this model.


Eligibility Criteria:
Inclusion Criteria:

* All patients receiving treatment with erlotinib monotherapy for locally advanced or metastatic NSCLC either first line in patients with an activating mutation of the receptor EGF-R or patients with stable disease after 4 cycles of standard first-line chemotherapy with platinum or after failure of at least one prior chemotherapy regimen
* Age\> 18 years
* Subject has signed an informed consent
* Treatment initiated for at least 7 days or dosage changed for at least 7 days

Exclusion Criteria:

* Contraindication to the use of drug
* Subject to exclusion period (as determined by a previous study or in progress)
* Inability to give informed information (subject in emergency situations, difficulties in understanding the subject, ...)
* Subject under judicial protection
* Subject under tutorship or curatorship
* Pregnancy (and woman of childbearing age without contraception)
* Breastfeeding
Effect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642, MK-8259-006)

This two-part study was to evaluate the effect of golimumab (SCH 900259, MK-8259) in participants with active axial spondyloarthritis (axial SpA). In Part 1, participants were to receive golimumab 50 mg or matching placebo subcutaneous injections on Day 1 (Baseline) and at Weeks 4, 8, and 12. During Part 1 of the study, participants were to not know the identity of the injection. In the Part 2 extension, all participants were to receive golimumab 50 mg subcutaneous injections beginning on Week 16 and then every 4 weeks up to Week 48. In Part 2, the participants were to be told they were receiving active study drug. The primary hypothesis of this study was that treatment with golimumab 50 mg every 4 weeks is superior to placebo as measured by the proportion of participants achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 16.


Eligibility Criteria:
Inclusion Criteria:

* Active axial spondyloarthritis with disease duration ≤5 years, and chronic back pain of ≥3 month duration
* Have either an inadequate response to 30 days of optimal daily doses of at least one non-steroidal anti-inflammatory drug (NSAID) or must be unable to receive a full 30 day maximal NSAID therapy because of intolerance, toxicity or contraindications to NSAIDs
* Females of child-bearing potential must use contraception
* No history of untreated latent or active tuberculosis

Exclusion Criteria:

* Fulfillment of modified New York criteria for ankylosing spondylitis
* Has ever received tumor necrosis factor (TNF)-α targeted therapy or any biological agents
* Any systemic inflammatory condition other than spondyloarthritis
* Serious infection within 2 months
* Any known malignancy or a history of malignancy within the previous 5 years
* Has or had a substance abuse (drug or alcohol) problem within the previous 2 years
Diagnostic Relevance of Salivary Testosterone Concentrations in Doping Control.

It is generally accepted that chemical testing of biologic fluids is the most objective means of diagnosis of drug use. In recent years saliva has attracted much attention. The prime advantage of saliva is that it offers non-invasive, stress-free and real-time repeated sampling whereas blood collection is undesirable, difficult and expensive. In addition, it is known that androgens such as testosterone can be assayed in saliva, as these steroids pass the endothelial-epithelial barriers by passive diffusion. Nevertheless, the correlations of blood, urine and saliva concentrations are not well documented. In recent reviews, it is pointed out that salivary hormone analysis could be a promising method for sports medicine and doping control, but much work is needed before the use of saliva samples in this area receives the acceptance. According to recent studies the increase of testosterone concentration in saliva is significantly higher than alterations of steroid concentrations (or ratios) in blood or urine. Saliva concentration may therefore serve as screening parameter to select suspicious cases for further target evaluation (e.g. by IRMS). This may be beneficial to identify cases of transdermal administration of low steroid doses. It is therefore the aim of the present project to detect administered testosterone in saliva and compare these levels to those in blood and urine. The intention is not to detect high dosage but low dosage abuse of testosterone, as a single-dose by patch application. From the practical point of view saliva could offer a complementary specimen for a pre-screening of testosterone. So it could be assumed that salivary testosterone exceed upon plasma and/or urine levels. So the present study could be the base for a new method to preselect the suspicious samples for testosterone abuse.


Eligibility Criteria:
Inclusion Criteria:

* male
* healthy
* informed consent

Exclusion Criteria:

* any metabolic, cardiovascular, pulmonary disorder
* neoplastic or hormonal disorders
* active sports competitor
* disorders which hinder cycling ergometry
An Open Multiple Dose Titration Study In Patients With Pulmonary Hypertension

This is a study to demonstrate the feasibility of an individual dose titration scheme based on the systolic blood pressure with a dose range from 1.0 mg TID to 2.5 mg TID. Patients suffering from chronic thromboembolic pulmonary hypertension (CTEPH) or pulmonary arterial hypertension (PAH) will be included. After diagnosis by an expert center, patients receive medication three times a day starting with 1.0 mg TID. The first tablets are given in the hospital, then the patients are allowed to go home and take the medication at home. After 2 weeks, patients return to the hospital for an ambulatory visit and the dose may be increased based on the actual condition of the patient (blood pressure and adverse events). Several measurements will be performed to test the efficacy of the drug and whether there are any unwanted reactions to the drug (blood tests, ECG, 6 minute walk test, imaging by Echo, quality of life scores). The dose of the drug will then be increased further until unwanted effects may occur or the blood pressure drops to low. The highest dose tested will be 2.5 mg TID. After 12 weeks the patient is going to stay in the hospital again and a right heart catheter is performed to examine the changes in hemodynamics after 12 weeks of treatment with the drug. If the patients give their consent they can enter a long-term extension trial continuing on BAY63-2521 with the dose reached after 12 weeks. Every 3 months an ambulatory visit at the specialist center will be performed including measurements of safety (blood tests, ECG, clinical assessment) and efficacy (6 minute walk test, Borg dyspnea scale, NT-pro BNP). Blood tests and ECG have been removed begin of 2013 as safety parameter by amendment 7; furthermore Borg dyspnea score and NT-proBNP have been removed as efficacy parameter.

Initially the inclusion of ten patients suffering from chronic thromboembolic pulmonary hypertension (CTEPH) or pulmonary arterial hypertension (PAH) was planned. Later on the patient number was amended and 75 patients entered the trial.

Furthermore the trial duration was extended and a long term treatment with BAY63-2521 was offered to the patients. Finally 68 patients moved over to the long term extension period of the trial.

Specification of primary outcome measures for long-term safety and tolerability: Adverse events, blood pressure and heart rate, 12 lead ECG, clinical chemistry and hematology, Troponin I

Eligibility Criteria:
Inclusion Criteria:

* Patients with CTEPH or PAH in NYHA class II or III

Exclusion Criteria:

* Patients with PDE 5 inhibitor or prostacycline pretreatment, relevant pulmonary diseases, relevant cardiac diseases, severe coagulation disorders, moderate to severe hepatic or renal insufficiency, pregnancy, hypotension
Linox Smart S DX PME/Master Study

The objective of this study is to prove the safety and efficacy of the Linox smart S DX ICD lead.


Eligibility Criteria:
Inclusion Criteria:

* Patients with standard ICD indication
* Be available for follow-up visits on a regular basis at an approved investigational center

Exclusion Criteria:

* Patients with standard ICD contra-indication
* Patients with permanent atrial fibrillation
* Have a life expectancy of less than six months
* Are expecting to receive cardiac surgery within 6 months after enrollment
* Age \< 18 years
* Not enrolled in another cardiac clinical investigation