cyrilzakka/clinical-trials huggingface dataset:
Echo Doppler (ED )Score and D-dimer (DD) Level in the Evaluation of VTE Recurrence After Anticoagulant Treatment Cessation

The purpose of this trial is to perform a prospective multicentric study to determine predictive ED score and D-dimer level in the evaluation of the thromboembolic event recurrence after anticoagulant treatment cessation.

The patients are included in the study from the anticoagulant treatment cessation. An ED score and a blood sample are performed at this time and one month later. Then, the patients are followed up by phone for 2 years.

DDimer levels are centralized in University Hospital of Grenoble at the end of the study

Eligibility Criteria:
Inclusion Criteria:

* \> 18 and \<80 years old
* First or second treated proximal VTE event (+/- Pulmonary embolism)
* Signed informed consent

Exclusion Criteria:

* Active cancer or currently treated
* Previous VTE\>2
* Long term anticoagulant treatment for VTE diseases
* Long term anticoagulant treatment for other diseases
* Pregnancy, parturient or breast feeding
* Person deprived of freedom by judicial or administrative decision
* Consent unsigned
A Study to Compare the Efficacy and Safety of Different Dosings of Olodaterol Administered With the Respimat® Inhaler in Patients With Moderate to Severe Asthma

This study will compare efficacy and safety of different regimens of olodaterol administration in asthma (once daily, twice daily) with placebo in a complete cross-over design each within one of the two daily dose groups (medium or high daily dose).


Eligibility Criteria:
Inclusion criteria:

1. Patients of either sex.
2. Aged 18 to 70 years.
3. A current diagnosis and a documented minimum 3 month history of asthma Global Initiative for Asthma (GINA) treatment steps 3 and 4.
4. Prebronchodilator Forced Expiratory Volume in one second (FEV1) \>= 60% predicted and \< 90% predicted according to European Coal and Steel Community (ECSC).
5. Increase in FEV1 \>=12% and \>=200 mL 15 min. after 400 µg salbutamol (albuterol);
6. Stable on medium to high dose inhaled corticosteroids (ICS) or low to high dose ICS in combination with a long acting beta-adrenergics (LABA) for at least 6 weeks prior to screening. Stable on ICS mono component of the former fixed LABA/ICS treatment for at least 48 hours prior to Visit 1b.

Exclusion criteria:

1. Patients with a significant disease other than asthma.
2. History of frequent seasonal exacerbations of asthma (defined as one or more seasonal exacerbations every year for the past three years).
3. Upper respiratory tract infection in the past 3 weeks prior to screening visit 1b.
4. Oral or other systemic corticosteroids in the past 6 weeks.
5. Patients with allergen desensitization therapy if started within two years, if they are not on an established maintenance regimen characterized by dose adjustments but no further increase to the tolerable maximum in the same course of immunotherapy.
A Prebiotic Agave Derivated Metlin & Metlos in Infant Formula

Objectives: To evaluate the safety; efficacy; bone mineral metabolism \& immunity changes of the use of Metlin \& Metlos added to the Infant Formula Study Design: Randomized, double blind, clinical, controlled trial, in 600 full-term infants of 15 ± 7 days randomized to recive formula with probiotics + Metlin + Metlos; formula with probiotics + Metlin; Formula with probiotics + Metlos; formula only with probiotics or formula without probiotics and prebiotics; having a totally breast feed group as control.). Outcomes variables were frequency of stools; bowel intolerance manifestations (abdominal distension, flatulency, regurgitations, vomiting); report of dermatological problems like eczema; changes on the intestinal microbiota; lipids profile (cholesterol, triglycerides, lipoproteins associated to cholesterol); anthropomorphic profile and somatic growth ( weight gain, stature, arm mean circumference, skin folds); bone mineral metabolism (high-speed bone ultrasonography); and changes in the immunity (changes in the concentrations of salivary IgA and the frequency of respiratory events suggestive of infection)\]. Statistical analysis was made with STATA Ver. 11.0 for Mac. Safety and efficacy variables, were compared by Chi squared in the case of categorical variables or by ANOVA or Kruskall Wallis for the numeric variables. When convenient, a covariates adjustment was done by ANOVA or by multiple lineal regressions for continuous numerical outcomes or logistic regression for categoric outcomes. In all the hypothesis tests the p significant value of \<0.05 were used.


Eligibility Criteria:
Inclusion Criteria:

* Healthy term babies (37 to 42 weeks of gestationl age)
* Age 15 ± 7 days at admission
* Birth weight \> 2,490 g.
* Negative history of formula intolerance (only randomized babies)
* Signed Informed Consent

Exclusion Criteria:

* Clinical evidence of chronic cardiac, respiratory, gastrointestinal, hematological or metabolic disease.
* Maternal medical history of diabetes (gestational diabetes was acceptable if the infant's birth weight was at or below the percentile 95; or 4153 g or 9 lbs 3 oz for girls or 4340 g or 9 lbs 9 oz for boys
* Tuberculosis, immunologic deficiency, infection disease or perinatal infections known to cause adverse effects in the fetus
* Participation in other study
* Inability of the father/mother or legal tutor to reed or comprehend the informed consent and the symtoms report diary, or
* The infant was part of multiple labor (twins, triplets, etc.)
Planning Your Everyday Life in Virtual Reality : a Study in Schizophrenia;

Patients with schizophrenia , who visit frenquently day-care or day-care activities clinics, often experience difficulties of daily living and cognitive deficits. Living independently is a key for recovery. Cognitive remediation is a therapy which reduces deficit and improves daily living. Nowadays no program exists targeting neurocognitive functions in virtual reality which could mimic everyday life in a virtual town.

Hypotheses :

* Persons with schizophrenia experience difficulties in daily living and disabilities to plan in everyday life. PLANI-REV program, a serious game with a navigation in a virtual town, in a 15 weekly group sessions could reduce these difficulties compared to the initial assessment. This improvement could be maintained 6 months after the end of the program.
* PLANI-REV could also improve prospective memory, attention, working memory, and visuospatial organization.
* PLANI-REV could induce a clinical improvement, as well as better perception of self-efficiency, self esteem, quality of life, and conversation skills.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 50 years old.
* Diagnostic of schizophrenia or schizoaffective disorder (DSM V), attested by the MINI structured interview (Shehan et al. 1998)
* Who visit for months or year, weekly or several times per week, a day care, or therapeutic activity units outpatients clinics and nursing homes
* French Mother tongue
* Consent of the legal representative caregiver for the patients under representative law (tutelle in French).
* Clinical Stability - Therapeutic stability for at least one month.
* National healthcare assurance

Exclusion Criteria:

* Central Neurological or non stabilized somatic diseases.
* Treatments for somatic disease with putative psychotropic effect.
* Electroconvulsive therapy in the last six months
* Illetrism
* IQ\< 70 established with the f-NART.
* Substance misuse or dependence (except Nicotine) or toxic for more than 5 years.
Atrial Fibrillation (AF) Clinic to Improve the Treatment of Patients With Atrial Fibrillation.

* Randomized controlled trial comparing specialized AF Clinic with 'care as usual'
* Hypothesis: treatment of AF patients in the AF-Clinic by a nurse, specialised in AF, using guideline-based dedicated software, under supervision of a cardiologist, is efficient, safe and not inferior to care as usual by a cardiologists.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed atrial fibrillation

Exclusion Criteria:

* Age \< 18 years
* unwillingness to participate
Combined Effect of Therapeutic Ultrasound and Trans Cutaneous Electrical Nerve Stimulation on Endometriosis

This study will be conducted to investigate the combined effect of therapeutic ultrasound and transcutaneous electrical nerve stimulation (TENS) on relieving adhesions and pain related to endometriosis.

Endometriosis affects 10-15% of reproductive-age women, causing pelvic pain and infertility. While laparoscopy is the primary treatment, it has risks. Medications are also used but often have side effects. Complementary therapies like acupuncture, yoga, and physical therapy modalities show promise. Therapeutic ultrasound has demonstrated effectiveness in managing chronic pain and adhesions associated with endometriosis. Transcutaneous electrical nerve stimulation (TENS) has shown positive results in pain relief and potentially improving uterine conditions for implantation. This study aims to investigate the combined effect of therapeutic ultrasound and TENS on endometriosis-related adhesion and pain, providing valuable information for physical therapists in treating this condition.

Eligibility Criteria:
Inclusion Criteria:

* Forty-five women clinically diagnosed by the gynecologist with endometriosis will be included in the study.
* Abdominal wall endometriosis will be diagnosed via Color Doppler ultrasonography.
* Their ages will range from 25 to 35 years old.
* Their body mass index (BMI) will be ranged from 25 to 35 Kg/m2.
* All patients have reported mild to moderate endometriosis symptoms such as (chronic pelvic pain (CPP), dysmenorrhea, dyspareunia, pain with bowel movements and urination and excessive bleeding) as recorded by Endometriosis Health profile questionnaire (EHP30).
* All patients use continuous hormonal treatment for at least 3 months.

Exclusion Criteria:

* Severe endometriosis which is diagnosed by the gynecologist.
* Pregnancy, peacemaker, epilepsy, cardiac arrhythmia, cancer, acute inflammatory pelvic disease.
* Use of injectable hormonal therapy within the previous 6 weeks.
* Patients with contraindication of ultrasound (Patients with reduced sensation to pain and/or heat, local malignancy, local acute infection and over areas of thrombosis or other vascular abnormalities).
* Cognitive deficiency and difficulty to understand instructions or use the instruments.
Efficacy of a Nutritive Bar, in Reduction of Weight, Body Fat and Control of Appetite

The main objective of the trial is to measure the efficacy of a nutritive bar, in the reduction of weight, body fat and the control of appetite, in patients with overweight and obesity. It will be a randomized single-blind design conducted in 40 subjects.

Primary objective and outcome: Difference in body fat percentage and summation of the absolute value of 7 body folds

Secondary objectives and outcomes:

* Characterize demographically and clinically the population participating in the research study.
* Determine the differences in body weight between the study groups.
* Determine the median of minutes of appetite onset in each of the groups. Design: The proposed study is a randomized, single-blind, paralell, single center study. Number of subjects: The number of subjects will be 40. At the start of the study, subjects will be randomly assigned to 2 different groups. All participants will have a evaluation with a nutritionist for an anthropometric assessment that includes the measurement of percentage of fat, sum of body folds, weight, height and Body Mass Index. All participants will receive a nutritional intervention providing a caloric deficit of 500 calories, depending on their daily requirements,and they will be prescribed moderate physical activity from 60 to 90 minutes daily. Participants will then be randomly assigned to gruop A: the nutritional bar group or group B: Control. Participants in group A will be instructed to consume the nutritional bar as an integral part of the previously established caloric regimen so as not to increase the number of prescribed calories and will be instructed to consume the product twice a day during the whole study, approximately 2 to 4 hours after breakfast and 2 to 4 hours after lunch, without additions of other foods or beverages, during consumption, may only be accompanied with water. Participants in group B will be instructed to consume a nutritious snack corresponding to the amount of calories provided by the bar, 2 to 4 hours after breakfast and 2 to 4 hours after lunch. The nutritional intervention will be carried out for 8 weeks for both groups, during the forth week and during the eight week of the intervention, a new nutritional assessment will be carried out with the same protocol of the first evaluation, by a nutritionist to all participants.

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obesity (BMI range between 25.0 and 35 kg per m2 and
* Percentage of fat ≥28 for women and ≥20 for men

Exclusion Criteria:

* Pregnant
* People with gastrointestinal, thyroid, renal, hepatic or cardiovascular diseases.
* Diabetics or hypertensive.
* People with eating disorders.
* Use of anti-obesity drugs in the last 4 weeks.
* Use of nutritional or medicinal anti-obesity supplements in the last 4 weeks.
* Celiac Disease.
* Allergies to peanuts, nines, eggs, milk or products derived from milk.
* Vegans.
* Physical or mental disability.
Biomechanical Effects of Duloxetine on Bladder and Sphincter Muscle Function in Women in Pure Genuine Stress Incontinence

Double-blind placebo-controlled study of the biomechanical effects of duloxetine compared with placebo in the treatment of women with pure genuine stress incontinence


Eligibility Criteria:
Inclusion Criteria:

* Female
* Between 18 and 75 years of age
* Diagnosis of GSI
* Have discrete episodes of incontinence

Exclusion Criteria:

* Positive urine culture at visit 1
* Use of MAOI
* Have had continence or urethral surgery
* Use of anti-incontinence device, vaginal pessaries or medications for the treatment of urinary incontinence
* Began pelvic floor muscle exercises within 6 months prior to study entry.
Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis

The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS, as defined by McDonald et al., criteria # 1-4 (McDonald et al., 2001)
* Between the ages of 18 and 50, inclusive.
* Baseline EDSS score between 0.0 and 5.0, inclusive.
* Have experienced at least one relapse within the 12 months prior to randomization.
* Cranial MRI scan demonstrating lesion(s) consistent with MS.
* Have given written informed consent to participate in the study.

Exclusion Criteria:

* Primary progressive, secondary progressive, or progressive relapsing MS.
* MS relapse has occurred,in the opinion of the investigator, within 50 days prior to randomization and/or the subject has not stabilized from a previous relapse.
* A clinically significant infectious illness within 30 days prior to randomization.
* History of, or abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal and/or other major disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent for 116 weeks.
* History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
* Unable to perform the Timed 25-foot Walk, 9HPT, and PASAT 3.
* Abnormal blood tests performed at the Screening Visit.
Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis

The aim of this study was to explore the efficacy and safety of a new vaginal microbiome transplantation technique, using Lactobacillus cispatus from healthy donors as a treatment of bacterial vaginosis.

The volunteers will be recruited from the women who come to the hospital to do the bacterial vaginosis test. After being informed about the potential risks, each volunteer giving written informed consent will be asked to complete a questionnaire.

Then, posterior fornix of vagina secretions will be taken from each volunteer to perform 16S rRNA gene sequencing microecology assessment , Clue cell detection and amine test.

After 2weeks ,1 month ,3 months,6 months,12 monthssince the entry, each volunteer will be asked to go back to research center to do the same sampling and examination as previously did in entry.

Eligibility Criteria:
Inclusion Criteria:

1. History of sexual behaviour 2.18-55 years old 3. Women were diagnosed as bacterial vaginosis

Exclusion Criteria:

1. During pregnancy, or within 8 weeks after delivery;
2. presence of systemic diseases (such as SLE, malignant tumors, etc.)
Role of Uterine Artery Embolization in Adenomyosis

Management of symptomatizing women diagnosed with uterine adenomyosis, by uterine artery angioembolization as a minimally invasive replacement for hysterectomy. This is followed by assessment of the symptoms and MRI of the pelvis after 3 months.

Adenomyosis is defined by the abnormal location of endometrial tissue within the myometrium associated with hypertrophy or hyperplasia of the myometrial stroma. Although pathogenesis and etiology of adenomyosis remain unknown, two main theories have been proposed: invagination of the endometrial basal layer and metaplasia of embryonic stem cells. Despite the absence of specific (pathognomonic) diagnostic features for uterine adenomyosis, typical symptoms include menorrhagia, chronic pelvic pain, and dysmenorrhea.

For more than a century, diagnosis was dependent on histopathologic examination of post-hysterectomy specimens till the introduction of noninvasive ultrasound and MR techniques. Since then, several studies have illustrated high sensitivities and specificities for both two-dimensional transvaginal sonography (TVS) and magnetic resonance imaging (MRI). Current treatment options for symptomatic adenomyosis include hysterectomy, medication, conservative surgery, or minimally invasive techniques including uterine artery embolization. To date, hysterectomy remains the definitive treatment. This is mainly due to difficult diagnosis, the diffuse nature of the disease, and little evidence-based literature needed to standardize treatments. This consequently results in a management dilemma, particularly in symptomatic patients who wish to preserve their uterus.

Uterine artery embolization is the use of transarterial catheters aiming to induce more than 34% necrosis within adenomyotic tissues. Vascular access is gained through a femoral or radial artery puncture using 4-6-French (F) arterial sheath for femoral and 4-F sheath for radial access. Under fluoroscopic guidance, aortography is followed by selective and super selective arteriography using 4-5-F catheters for the internal iliac and 2-3-F microcatheters for the uterine artery and its branches respectively. Embolization is usually performed using variable-sized permanent particulate agents.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatizing women (pelvic pain and/or bleeding) between ages 30-50 who are not keen on hysterectomy.

Exclusion Criteria:

* Women who desire further child bearing (not completed their family yet).
* Impaired coagulation profile.
* Hypersensitivity to intravenous contrast media.
* Decompensated congestive heart failure.
* Hypertensive crisis.
* Stroke or CVA.
* Renal failure.
Safety and Efficacy of Trans Sodium Crocetinate (TSC) With Radiation and Temozolomide in Newly Diagnosed Glioblastoma

This open-label study evaluated the safety and efficacy of TSC when dosed concomitantly with the standard of care (radiation therapy and temozolomide) for newly diagnosed glioblastoma in adults. All patients received TSC in the study. The objective of the study was to evaluate the effect of TSC on survival and tumor response in patients with GBM while establishing an acceptable patient risk profile.

The overall objectives of this Phase 1/2 clinical study in newly diagnosed GBM patients was to evaluate the safety and tolerability, efficacy, PK profile, PFS/time to disease progression, QoL, and overall survival in adults when TSC is added to the standard of care regimen of radiation therapy and temozolomide. All patients received TSC in this study. The primary objective of the Phase 1 portion of the study was to evaluate the safety (DLT rate) and to define the dosing regimen of TSC for the larger Phase 2 study. The primary clinical endpoint was overall survival at 24 months and patients will be followed for up to 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Aged at least 18 years of age; male or female. A patient who is 70 years of age or older may be considered for enrollment after review of patient clinical and laboratory data by the Protocol Medical Monitor.
* Histologically confirmed diagnosis of GBM.
* Contrast enhancing disease on MRI within 21 days prior to screening.
* Karnofsky score (KPS) of ≥ 60 at Screening.
* No prior RT, chemotherapy (including Gliadel wafer), immunotherapy or therapy with a biologic agent, or hormonal therapy. Glucocorticoid therapy is allowed.
* Within 2 weeks of baseline visit, hematologic and renal functions as specified: Absolute neutrophil count ≥ 1500/mm3, platelets ≥ 100,000/mm3, Hgb ≥ 9.0g/dL, creatinine ≤ 1.7mg/dl, total bilirubin ≤ 1.5mg/dL, blood urea nitrogen (BUN) within 2 times the upper limit of normal, transaminases ≤ 4 times above the upper limits of the institutional norm.
* Sexually active patients must use an acceptable method of contraception while receiving doses of study medication.
* Females of childbearing potential must have a negative serum or urine pregnancy test at screening and have additional pregnancy tests during study.

Exclusion Criteria:

* Patient who cannot undergo MRI.
* Pregnant or lactating.
* Serious concurrent infection or medical illness that would jeopardize the ability of the patient to receive study treatment with reasonable safety.
* Patient receiving concurrent chemotherapeutics or investigational agents within 30 days of baseline assessments, including gliadel wafers or gliasite application.