cyrilzakka/clinical-trials huggingface dataset:
Obesity, Physical Inactivity or Dietary Fat ?

Obesity is the consequence of a chronic disequilibrium of fat balance. Genetic factors determine predisposition to obesity, but the most often mentioned idea is that environmental factors, such as a high-fat diet and a sedentary lifestyle, join to favour weight gain and explain the increased prevalence of obesity in our westernized societies. Since lipogenesis is negligible in humans, obesity represents the consequence of altered fat partitioning between oxidation and storage, likely due to a preferential directing of dietary fat towards adipose tissue and away from muscle. Interventions that favour partitioning of dietary fat towards muscle for oxidation might thus protect against weight gain. Exercise may be one kind of such intervention but the scant data on dietary fat metabolism does not allow clear conclusions, in particular in obese subjects. One question concerns the impact of the type of fat eaten: the effects of physical inactivity may vary according to the length and saturation degree of the fatty acids. We hypothesize that 1) physical activity of moderate intensity, independently of its effect on energy balance, will favor a preferential trafficking towards adipose tissue, will modify the expression of genes implicated in fat oxidation and storage and partly correct the abnormalities observed in obese subjects, 2) effects of physical activity vary according to the saturation degree of fat. Twelve obese subjects, aged 18 to 55, will undergo tests before and after 2 months of training at current recommendations to ascertain dietary fat partitioning using stable isotopes and to determine changes in gene expression with muscle and adipose tissue microbiopsies.


Eligibility Criteria:
Inclusion Criteria:

* Men between 18 and 55
* IMC \>25 and \<30 kg/m2 and waist circumference \>102 cm
* Familial antecedents of obesity
* Physical inactivity (PAL\<1.5, according to MOSPA-questionnaire and accelerometry)
* Acceptation of physical training and body weight control during the study

Exclusion Criteria:

* Any drug interfering with energetic or lipid metabolism
* Any contradiction to moderate physical training
* Diabetes or arterial hypertension treatment
* Any other pathology (cardiovascular, psychiatric, renal or hepatic disease, viral hepatitis or VIH)
* Consumption of more than 40 g alcohol per day
* Recent voluntary or involuntary weight modification (3kg the next three months)
* A recent trip outside France before and during stable isotope measures.
Paracervical Pouch in Placenta Accreta Spectrum

The study objective is the significance of the ultrasound detection of the paracervical pouch in placenta accreta spectrum. It aimed to evaluate its relation to the degree of placenta accreta spectrum, amount of the blood loss and the number of packed red blood cells transfused.

The study will be carried on patients diagnosed with placenta previa or placenta accreta spectrum and had at least one caesarean section. The study will be divided into 2 groups of 70 patients at least per each. The first group will include patients in whom a paracervical pouch is detected, and the second group will include patients in whom the pouch is not detected by transvaginal ultrasound.

paracervical pouch is defined ultrasonographic as the downward displacement of the uterine serosa from the level of the cervical internal os

Eligibility Criteria:
Inclusion Criteria:

* • Patients between 19 to 40 years old

  * Patients had at least one cesarean section.

Exclusion Criteria:

* • Patients who request hysterectomy.

  * Patients diagnosed with hepatitis B, C, or HIV,
  * Those with bleeding diathesis.
  * Patients whose BMI is more than 40 kg/m2.
  * Patients who need an emergency cesarean section.
ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic Dissection

Assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft

This study is a prospective, multicenter, non-randomized single-arm study to assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft.

Eligibility Criteria:
Inclusion Criteria:

1. DeBakey Type I/II aortic dissection compatible with the treatment requirements of GORE® Ascending Stent Graft, including:

   * Primary entry tear must be in the ascending aorta and ≥2cm distal to the most distal coronary artery ostia
   * Ascending aorta compatible with the GORE® Ascending Stent Graft including landing zone true lumen diameter between 24mm - 42mm and total aortic landing zone diameter ≤ 45 mm
2. Able to undergo CT scan per protocol requirements to perform required case planning prior to endovascular procedure
3. High surgical risk, as determined by the implanting physician
4. Adequate vascular access via transfemoral or retroperitoneal approach
5. An Informed Consent Form signed by Subject or legally authorized representative
6. Able to comply with protocol requirements including follow-up

Exclusion Criteria:

1. Planned aortic valve repair or replacement or coronary artery intervention within 30 days
2. Presence of mechanical heart valve in the aortic position
3. Primary entry tear location in the aortic arch or descending thoracic aorta with retrograde flow into the ascending aorta
4. Aortic insufficiency grade 3+ or 4+
5. Known irreversible neurological injury
6. Known degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
7. Participation in another drug or medical device study within 1 year of study enrollment
8. Known history of drug abuse
9. Pregnant female at time of informed consent signature
10. Body habitus or other medical condition which prevents adequate visualization of the aorta
11. Systemic infection that could increase the risk of endovascular graft infection
12. Previous thoracic aortic surgery
13. Life expectancy \<12 months due to associated non-cardiac co-morbid conditions
14. Subject has known sensitivities or allergies to the device materials
15. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
16. Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment
Non-invasive Evaluation Program for TIPS and Follow Up Network 2 (NEPTUN2)

Evaluation of non-invasive prognostic parameters in patients receiving transjugular intrahepatic portosystemic shunt (TIPS) for complications of portal hypertension. Patients are cared according to the local standardized follow up program. Clinical and laboratory data from standard patient care are evaluated for potential prognostic value.

NEPTUN consists of liver cirrhosis receiving transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Internal Medicine I, University of Bonn, Germany and receiving a structured routine evaluation and follow up program. The diagnosis of cirrhosis was based on clinical, hemodynamic and biochemical parameters, and ultrasound and/or biopsy criteria.

Eligibility Criteria:
Inclusion Criteria:

* Insertion of TIPS according to guidelines

Exclusion Criteria:

* Contraindication for TIPS
Viome Precision Nutritional Programs to Improve Clinical Outcomes for Mental Health Conditions

US residents who have obesity and sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of two arms. This study is direct to participant and will not utilize clinical sites.

Participants who meet the eligibility criteria are randomized into any of the two arms including: the placebo arm or the VIOME Precision Nutrition Program (VPNP) arm.

Placebo and Viome's Precision Nutrition Program include supplements and/or dietary recommendations towards improving the symptoms associated with metabolic wellness. The trial will last approximately 4 months for each participant.

Eligibility Criteria:
Inclusion Criteria:

* Resident of the United States
* 50 years old and older OR BMI of 25 or greater
* Able to speak and read English
* No unexplained weight loss, fevers, anemia, or blood in stool
* Willing and able to follow the trial instructions, as described in the recruitment letter
* Signed and dated informed consent prior to any trial-specific procedures.
* PHQ9 score of 5-24 (inclusive)

Exclusion Criteria:

* Unwilling to change their current diet
* Prior use of Viome products or services
* Antibiotic use in the previous 4 weeks
* Pregnancy (current or planned in the next 4 months)
* \< 90 days postpartum
* Breast feeding
* Active infection
* Unable or unwilling to use Viome's App on an iPhone or Android smartphone
* Significant diet or lifestyle change in the previous 1 month
* IBD diagnosis -Major psychiatric/DSM-4 disease diagnosis (e.g. Schizophrenia, Bipolar disorder, Post- traumatic Stress Disorder, Obsessive Compulsive disorder)
* Use of investigational drugs, products or devices within 1 month prior to and 4 months after the start of the trial
* Cancer therapy within the previous 1 year
* Major surgery in the last 6 months or planned in the next 4 months
* Allergies to any supplement ingredients listed in the screening survey
* Currently on a specific diet: FODMAP, KETO, PALEO
* Answered yes to the question, "In the past few weeks, have you wished you were dead or had thoughts about killing yourself?"
* Gastrointestinal disease including:

  * GI surgery except:

    * Appendectomy and benign polypectomy
* Esophagitis
* Celiac disease
* GI malignancy or obstruction
* Peptic Ulcer Disease
* Duodenal or gastric ulcer disease
Autologous Stromal Vascular Fraction in Treatment of Male Androgenic Alopecia

Evaluation of Safety and efficacy of autologous stromal vascular fraction derived from denovo versus platelet rich plasma enhanced donner site in treatment of male androgenic alopecia

40 Patients with androgenic alopecia will be randomly divided into 2 groups Group A (20): will receive 2 session of stromal vascular fraction directly after fat harvesting and processing and stromal vascular fraction extraction with 1 month interval .

Group B(20): will be injected with 2 session of Platelet rich plasma 3weeks interval at site of fat harvesting and will be followed 1 month later with fat aspiration from site where Platelet rich plasma was previously injected and this fat will undergo fat processing and stromal vascular fraction extraction followed by 2 session of stromal vascular fraction injection at scalp 1month interval .

Patients at both groups will receive topical and systemic antibiotics after stromal vascular fraction injection .

Eligibility Criteria:
Inclusion Criteria:

* Male patients with androgenic alopecia

Exclusion Criteria:

* Patients with other hair loss disorders as telogen effluvium, anagen effluvium, alopecia areata, cicatricial alopecia and trichotillomania.

Any other cutaneous disease as patients suffering from dermatological condition or a significant scarring in the treatment area.

Any systemic disease as autoimmune disorders , cardiac hepatic and renal patients.

patients who received minoxidil or any other oral, topical medications (including herbal medications) or injection procedures for the treatment of hair loss within 6 months prior to the study, or finasteride or dutasteride within 12 months of the study
Effect of Non-surgical Periodontal Treatment on Oxidative Stress and Antioxidant Status in OSAS

The main objective of this study is to compare the effect of the non-surgical periodontal treatment on serum and saliva oxidative stress parameters in patients with periodontitis and obstructive sleep apnea syndrome (OSAS) and in patients with periodontitis only.

There is evidence supporting that OSAS is an independent risk factor for cardiovascular and cerebrovascular diseases such as hypertension, congestive heart failure, myocardial infarction, cardiac-arrhythmia, and stroke.Gender, age, smoking, obesity and diabetes, which are risk factors for periodontitis,It is also common in OSAS at the same time.In addition to common risk factors, both OSAS and periodontitis have been shown to be associated with increased oxidative stress markers.

The investigators aimed to investigate whether non-surgical periodontal treatment on serum and saliva oxidative stress parameters in patients with periodontitis and obstructive sleep apnea syndrome (OSAS) and in patients with periodontitis only.

Eligibility Criteria:
Inclusion Criteria:

* aged ≥18 years old
* having more than 16 teeth
* BMI\>25 kg/m2

Exclusion Criteria:

* patients with a history of diabetes mellitus or respiratory diseases
* patients who were under any medication that was known to influence periodontal tissues
* patients with a history of any periodontal treatment in the past 6 months
* patients with hormonal changes such as pregnancy or lactation; and 5) patients having fixed dentures or removable prothesis
* OSAS treatment started (using OSAS therapy device or undergoing surgical operation)
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants


Eligibility Criteria:
Inclusion Criteria:

* Japanese male or female infants ≥2 months to ≤6 months at the time of consent.
* Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Exclusion Criteria:

* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
* Major known congenital malformation or serious chronic disorder.
* History of microbiologically proven invasive disease caused by S pneumoniae.
* Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Daily Bi-temporal Transcranial Random Noise Stimulation in Tinnitus

Stimulation of the left and right auditory cortex with daily transcranial random noise stimulation (tRNS) is used to modulate the neural pathways involved in chronic tinnitus.

Tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. It is a frequent problem which can interfere significantly with the ability to lead a normal life. Tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory neural pathways and the central auditory system. These changes are represented by hyper-activity and hyper-synchronicity in the auditory pathway. Treatment remains difficult. Non-invasive brain stimulation methods has shown to be effective in the treatment of chronic tinnitus with moderate effect size. Preliminary data presented on international conferences suggest the use of transcranial random noise stimulation (tRNS) over both auditory cortices as new and highly effective treatment. High-frequency (hf; 100-650Hz) tRNS might be highly effective in tackling hyper-synchronised cell assemblies. Daily Hf-tRNS (2 weeks) will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in an one-arm pilot trial.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bothersome, subjective chronic tinnitus
* Diagnosis: Duration of tinnitus more than 6 months

Exclusion Criteria:

* Objective tinnitus
* Irregular head shap below the electrodes
* Eczema on the head
* Treatable cause of the tinnitus
* Involvement in other treatments for tinnitus at the same time
* Clinically relevant psychiatric comorbidity
* Clinically relevant unstable internal or neurological comorbidity
* History of or evidence of significant brain malformation or neoplasm, head injury
* Cerebral vascular events
* Neurodegenerative disorder affecting the brain or prior brain surgery
* Metal objects in and around body that can not be removed
* Pregnancy
* Alcohol or drug abuse
P2 Study of Postoperative Interferon/Fluorouracil vs Cisplatin/Fluorouracil for Hepatocellular Carcinoma.

To evaluate the efficacy and safety of postoperative hepatic arterial infusion chemotherapy, interferon/fluorouracil versus low-dose cisplatin/fluorouracil, in patients with hepatocellular carcinoma with portal vein tumor thrombus.

No standard treatment has been established for highly advanced hepatocellular carcinoma (HCC) invading the major branches of the portal vein except for sorafenib. Some reports suggested that hepatic arterial infusion chemotherapy improved survival of these patients. Other reports indicated surgical intervention improved that survival. However, there is no standard adjuvant therapy after liver resection for the patients with HCC with portal vein tumor thrombus in the main or first branch of the portal vein. Our preliminary results showed that combined interferon-alpha and intra-arterial 5-fluorouracil (5-FU) as a postoperative therapy prolonged disease-free and overall survival after liver resection. Hepatic arterial infusion chemotherapy using low-dose 5-FU and cisplatin is also promising regimen for advanced HCC.

Herein, the investigators planed the study to evaluate efficacy (two year survival as primary outcome, and overall-survival as secondary outcome) and safety ( as secondary outcome) in hepatic arterial infusion chemotherapy with continuous infusion of 5-fluorouracil and systemic administration of interferon-alpha or low-dose 5-FU and cisplatin, and to compare the efficacy as randomized control trial.

Eligibility Criteria:
Inclusion Criteria:

1. hepatocellular carcinoma with histological or evidence or typical findings by CT or MRI.
2. surgically resectable tumors with tumor thrombus in first branch or main trunk of portal vein.
3. 20 years old or more.
4. Eastern Cooperative Oncology Group Performance status of 0 or 1.
5. Life expectancy of at least 6 months at the pre-treatment evaluation.
6. Child-Pugh class A or B.
7. Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements.

white blood cell count \>= 2000/microliter, Neutrophil \>= 1000/microliter, Hemoglobin \>= 9.0 g/dL, Platelet count \>= 75000/microliter, Total Bilirubin \<= 1.5mg/dl, aspartate aminotransferase(AST) /alanine aminotransferase(ALT) \<= 150 IU/L, Serum creatinine \<= 1.2mg/dL, Creatinine clearance \>= 60 ml/min

-

Exclusion Criteria:

1. Histological diagnosed combined hepatocellular and cholangiocellular carcinoma.
2. Extrahepatic tumor spread which affects patient's prognosis.
3. Hepatic encephalopathy
4. Active infections except for hepatitis B virus(HBV) and hepatitis C virus(HCV).
5. Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on)
6. Active double cancer
7. Pregnancy 8-10) Medication or treatment that may affect to the absorption of drug or pharmacokinetics.

11) others, in the investigator's judgment.

-
Chronic Venous Insufficiency and Balneotherapy

The aim of this clinical trial is to assess the efficacy of the balneotherapy program (therapeutic orientation: Phlebology) in terms of chronic venous disease improvement and related quality of life, in patients presented with advanced chronic venous insufficiency (i.e., with C4-C5 of severity classification).

The multicenter randomized controlled trial (RCT) "Thermes \& Veines" that aimed at evaluating balneotherapy in patients with advanced chronic venous insufficiency is considered as the reference study. The French National Academy of Medicine encourages the re-use of data of published RCT when available. In this context, the current study is designed as a single-arm prospective study with indirect comparison using propension score. The Control group consists of the 197 patients which were allocated to the Control group of the "Thermes \& Veines".

All patients enrolled in the current study benefit of 18-days of spa treatment with Mineral Water of Royat, and examination with vascular practitioner at enrollment and 6 months after the beginning of spa treatment.

Chronic Vascular Disease (CVD) related quality of life and symptoms, as well as skin trophic changes from baseline are assessed at 6 months. Variations from baseline are compared in Control and Spa treatment groups. The indirect comparison methodology is based on the reuse of individual data from a "control" group and adjustment after calculating the propensity score.

Eligibility Criteria:
Inclusion Criteria:

* Primary or post-thrombotic CVD with confirmed diagnosis by by duplex ultrasound examination (last available exam);
* With CVI classified as C4a, C4b, or C5)
* Available for balneotherapy program within the 2 next months
* With health insurance affiliation.

Exclusion Criteria:

* Active venous thrombosis, recent or ongoing erysipelas, peripheral arterial pathology (ankle brachial index \< 0.70).
* Walking difficulty
* Neurologic diseases of the lower limbs
* Presenting or likely to present a contraindication to thermal treatments, with planned surgery;
* Having already benefited from a thermal treatment whatever the indication during the last 6 months
* Chronic infectious disease, cancer, heart, kidney or liver failure;
* Pregnant, breastfeeding women or women planning a pregnancy within the year;
* Persons deprived of their liberty or subject to psychiatric care or subject to a measure of legal protection or unable to express their consent;
* Patient likely to not respect the protocol or not to be able to attend the visits, particularly given the study follow-up;
* Living at more than 30 minutes from the thermal site or who cannot be accommodated less than 30 minutes from the thermal site;
* Already included in a clinical trial or in the exclusion period of a clinical trial.
Kahn Study; Investigation Of The Efficacy Of Ziprasidone Versus Olanzapine In The Management Of Recent-Onset Psychosis; A Flexible-Dose, Parallel Group, Double-Blind Study

This study intends to compare novel antipsychotics ziprasidone and olanzapine, to confirm the findings of an open study -where stable patients receiving olanzapine switched to ziprasidone- which showed maintenance of clinical effect with improvements in all domains of cognitive function at 6 weeks (Daniel, 1999). Direct comparison of the two agents in a well-controlled double-blind fashion will allow an evaluation of the effect on cognitive function in the short and long-term management of patients with recent-onset schizophrenia, schizoaffective and schizophreniform disorder.


Eligibility Criteria:
Inclusion Criteria:

* Duration of illness \< 5 years (according to DSM-IV and onset first psychotic episode); CGI severity score \> 4 (moderately ill)
* maximum exposure to antipsychotic treatment of =\< 16 weeks.

Exclusion Criteria:

* Concurrent treatment with antipsychotic agents =\< 12 hours prior to randomization
* for depot agents a period of two weeks or one cycle, whichever is the longer, must occur between last administration and randomization
* Treatment with antidepressants or mood stabilizers =\< 7 days of randomization
* for MAOIs and moclobemide this period must =\< 2 weeks
* for fluoxetine =\< 5 weeks