cyrilzakka/clinical-trials huggingface dataset:
Psychological Flexibility and Effectiveness of Psychotherapy

The Objectives of the current research is to evaluate whether psychological flexibility influences psychotherapy outcomes in patients with adjustment disorder and depression. If indeed this is the case, we would be able to identify risk factors for low adjustment- such as low psychological flexibility, and develop psychotherapy that would try to enhance this ability.

Subjects will be recruited from the Psychiatric daycare center at the Tel-Aviv Souraski Medical Center, serving the broader Tel-Aviv municipal area. Referrals to the department will be screened for eligibility to participate in the study according to the study's inclusion and exclusion criteria. Inclusion criteria would be adjustment disorder as the referral cause, age ranging from 20 to 65 years old and Hebrew speaking. Patients with major depression, a psychotic disorder, alcohol or drug dependence will be excluded. All participants will sign a written informed consent. The diagnosis of adjustment disorder will be conﬁrmed by an open clinical interview followed by a Structured Clinical Interview for DSM-IV SCID-IV (Shalev et al. 1994; First et al. 1995).

Before starting the psychotherapy treatment, the patients will fill a psychological flexibility questionnaire (PFQ) and well-being questionnaire (MHI), in order to evaluate their psychological flexibility and well-being baseline. At the end of the psychotherapy treatment, they will fill the questionnaires again. Also, their therapists will evaluate the patients' levels of adjustment disorder or depression before and after the therapy.

Eligibility Criteria:
Inclusion Criteria:

Adjustment disorder as the referral cause, age ranging from 20 to 65 years old and Hebrew speaking. The diagnosis of adjustment disorder will be conﬁrmed by an open clinical interview followed by a Structured Clinical Interview for DSM-IV SCID-IV (Shalev et al. 1994; First et al. 1995).

Exclusion Criteria:

Patients with major depression, a psychotic disorder, alcohol or drug dependence will be excluded.
Molecular Imaging Modality by Positron Emission Tomography Using 18F-X : Study of Microglial Activation in Amyotrophic Lateral Sclerosis

PET imaging of activated microglia offers a tool of investigation of a range of brain diseases where neuroinflammation is a component.

Amyotrophic lateral sclerosis is the most frequent motoneuronal disease in adult.

This study was designed to explore the feasibility of molecular imaging modality by Positron Emission Tomography using 18F-X as an in vivo marker of activated microglia for the assessment of neuroinflammation in amyotrophic lateral sclerosis.

PET may help in the diagnosis of the disease and, further, may allow assessment of the efficacy of antiinflammatory treatment.

18F-X PET will be carried out requiring arterial sampling in 2 patients suffering from ALS and 2 normal subjects in order to evaluate the 18F-X quantification.

Then simplified PET using 18F-X will be carried out in 13 patients and 13 normal subjects.

Binding potential maps showing specific binding of 18f-X will be generated for each subject.

Regional binding potential values will be calculated for anatomically defined regions of interest after coregistration to and special transformation into the subject's own MRI.

Eligibility Criteria:
Inclusion Criteria:

* suffering from probable or definite form of amyotrophic lateral sclerosis according to El Escorial criteria. Spinal or bulbar site of the disease.
* Information and signature of the written consent form
* French Social Security registration

Exclusion Criteria:

* family history of ALS
* Riluzole treatment before the first PETscan.
* Psychiatric disorders
* Evolution of the disease older than 18 months
* Antiinflammatory or antibiotic treatment in the last month
Cross-linked Volume-stable Collagen Matrix Versus Connective Tissue Graft At Implant Site.

Recent data suggested that an adequate volume of Keratinized Tissue (KT) around dental implant is a key factor to obtain aesthetic outcomes and to support easy long-term maintenance.

The aim of this RCT is to test the volume-stable collagen matrix (VCMX) vs the Connective Tissue Graft (CTG) for peri-implant soft tissue augmentation during implant uncovering.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* No systemic diseases or pregnancy.
* Self-reported smoking ≤10 cigarettes/day.
* No probing depths ≥5 mm
* Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤15% (measured at four sites per tooth).
* Single dental implant with a scheduled for soft tissue augmentation procedure at the time of uncovering.
* Need of soft tissue augmentation for aesthetic purpose and/or functional reasons
* No previous soft tissue augmentation procedure at experimental site.

Exclusion Criteria:

* General contraindications for dental and/or surgical treatments
* Concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid therapy
* Inflammatory and autoimmune disease of oral cavity
* History of myeloma, respiratory tract cancer, breast cancer, prostate cancer or kidney cancer requiring chemotherapy or radiotherapy within the past five years
* Radiotherapy of head area
* Disease or condition affecting connective tissue metabolism (e.g. disease of arteries in the operating zone, bone metabolic diseases, alcohol abuse, treatment with anticoagulants)
* Any systemic diseases that affect bone metabolism (e.g thyroid dysfunction, autoimmune disease)
* Untreated acute periodontal disease
* Patients who smoke more than 10 cigarettes/day will be excluded from the study
* Diabetes
* Allergy to the collagen
* Pregnant or lactating women
* Women of child bearing age, not using a highly effective method of birth control
* Participation in an investigational device, drug or biologic study within the last 24 weeks prior to the study start
Microbial Biomarkers of EArly Pseudomonas Aeruginosa Colonization in CHildren With Cystic Fibrosis

The objective of this study is to evaluate the predictive nature of the biomarker Porphyromonas catoniae measured at the age of 12 months in the occurrence of colonization with Pseudomonas aeruginosa at 36 months of age in children with cystic fibrosis.

This is a multicentric study in 3 phases:

* Pre-inclusion: at the first visit to the CRCM (support for a positive screening confirmed by sweat test and genotyping CFTR)
* Inclusion: possible between the 2nd visit to the CRCM (about 2 months old) and the 6th month
* Follow-up: up to 36 months old. The pace of visits will be based on the usual follow-up rate of CF infants

The clinical data as well as samples (expectorations, stools) will be collected on a monthly basis up to 6 months old and then every 2 months until one year old and finally quarterly until 3 years old.

* Tracheo-bronchial secretions will be collected at the CRCM
* Stools samples will be carried out by the parents prior to consultation with the CRCM
* A blood collection will be carried out annually in an annual report.

Eligibility Criteria:
Inclusion criteria:

* Infants aged 6 months maximum at inclusion with a confirmed diagnosis of cystic fibrosis in its classical form (positive sweat test and/or two mutations of the CFTR gene from class I to III)
* Children free from any antecedent of colonization to P. aeruginosa at the time of inclusion (certified by the microbiological history supplemented by a molecular test by qPCR according to the diagram of Le gal et al., 2013)-Affiliation to the social security system
* Consent signed by the holders of parental authority or the sole parent holding parental authority / and "oral" agreement of the second holder

Exclusion criteria:

* Severe acute pathology (other than cystic fibrosis) in progress, or requiring surgery
* Children unable to undergo the tests required for the Protocol
* Children whose parent (s) is (are) minor (s)
* Children whose parental authority does not master the French language
* Refusal to participate in the study
Safety and Effectiveness of Soy Phytoestrogens to Prevent Bone Loss

The purpose of this study is to determine whether soy isoflavone supplementation is safe and effective to prevent bone loss in postmenopausal women.

Over-the-counter soy isoflavone supplement usage is becoming common among postmenopausal women. However, there is no documented scientific evidence of its long-term safety and efficacy in preventing osteoporosis. Our primary goal is to determine the safety, efficacy, and optimal dosage of isoflavone supplementation to reduce bone loss in postmenopausal women. The multi-state, multi-institutional design ensures that the study results are representative of postmenopausal women in the U.S. population. Confirming the skeletal benefits of soy isoflavones could translate into reduced healthcare costs related to osteoporosis.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to swallow the pills
* No menses for 12 months
* Blood follicle stimulating hormone great than 30 IU/mL
* Lumbar spine bone mineral density t-score equal to or greater than -1.5

Exclusion Criteria:

* Strict vegetarians
* Current or recent smokers (within last five years)
* Abnormal screening mammogram, Pap smear and blood chemistries
* Clinical diagnosis of osteoporosis, spine and/or hip fracture, cancer, liver, kidney, gallbladder and heart disease
* Clinical diagnosis of psychiatric disorder
* Any allergic reactions to soy products
* Current treatment with bisphosphonates, calcitonin, fluoride, corticosteroids, tamoxifen, raloxifene, HRT, premarin, farestron and letrozole
* Current usage of black cohosh, blue cohosh, dong quai, Caltrate 600+Soy, Estroven, ginseng, Healthy Women, Natural Estrogen, Opti-Soy, PhytoFem, Probalance, Promensil, Remifemin, Rimostil and Trinovin
NMES and Pelvic Fracture Rehabilitation

Objectives: The acute care of pelvic fractures has improved recently however there are no formal guidelines for rehabilitation of these types of fractures. Patients have long periods of non-weight bearing causing muscle wastage. Neuromuscular electrical stimulation (NMES) has proven to minimise muscle loss. However, this has not previously been investigated within this patient population.

Design: Double blind, randomised, feasibility study.

Setting: NHS trust hospital setting.

Participants: Nine patients with surgically fixed pelvic fractures were randomly allocated at six weeks post fracture.

Interventions: The intervention group completed six weeks of NMES. The placebo group used transcutaneous electrical nerve stimulation (TENS).

Main outcome measures: Peak torque (Nm) was calculated in the operated limb at 12 weeks using the non-operated limb as a baseline. Compliance and intensity levels were recorded. Feasibility of NMES was evaluated using a feasibility questionnaire. Pain was measured at six and 12 weeks using a visual analogue scale (VAS).


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were any patient with a pelvic fracture that was surgically fixed with no associated injuries and able to give written informed consent.
* Pelvic fractures including acetabular and pelvic ring fracture that were fixed using open reduction internal fixation (ORIF) were considered.

Exclusion Criteria:

* Exclusion criteria were patients who could not comply with the NMES or who had previous mental health diagnosis.
* Patients who may be pregnant, have severe kidney injury or have a pacemaker were excluded.
High-density in Spinal Cord Stimulation: Virtual Expert Registry

This is a prospective, multi-center, observational follow-up study observing the effectiveness of high density spinal cord stimulation in patients with failed back surgery syndrome patients with back and leg pain.

DISCOVER will measure the effectiveness of high-density spinal cord stimulation for treatment of chronic back and leg pain. Identification of clinical effective parameters concerning location of active electrodes, frequency, pulse duration, amplitude and battery consumption are, besides safety, the major outcome parameters of this study.

Eligibility Criteria:
Inclusion Criteria:

* Failed Back Surgery Syndrome patients (FBSS) with insufficient pain reduction with conventional SCS or FBSS patients suitable for SCS
* Age \> 18 years
* Chronic pain as a result of FBSS that exists for at least 6 months with a pain intensity 5 or higher measured on numeric rating scale (NRS)
* Patient has been informed of the study procedures and has given written informed consent
* Patient willing to comply with study protocol including attending the study visits

Exclusion Criteria:

* Expected inability of patients to receive or properly operate the spinal cord stimulation system
* History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew
* Active malignancy
* Addiction to any of the following drugs, alcohol (5E/day) and/or medication
* Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
* Immune deficiency (HIV positive, immunosuppressiva, etc.)
* Life expectancy \< 1 year
* Local infection or other skin disorder at site of incision
* Pregnancy
* Other implanted active medical device
Effects of Exercise on Cardiac Fat in Women With Obesity: a Pilot Study

Excessive cardiac fat accumulation have been recognized to be associate to increased cardiac and metabolic risk. The aim of this study the effects of exercise in cardiac fat content, cardiac function, physical fitness, and metabolic activity in obesity.

Excessive cardiac fat accumulation have been recognized to be associate to increased cardiac and metabolic risk. More effective treatments are needed to induce changes in cardiac fat content, body composition, and cardiac fat metabolic activity that result in a reduction in cardiovascular risk in overweight and obese population. Despite this need, little is known about which mode, frequency, and duration of exercise will allow for greater reductions in cardiac fat, improvements in body composition, restoration of a healthy cardiac fat metabolic activity, and improvement on cardiovascular risk markers. The aim of this study the effects of exercise in cardiac fat content, cardiac function, physical fitness, and metabolic activity in obesity.

Eligibility Criteria:
Inclusion Criteria:

* BMI 30-39.99
* White/Caucasian

Exclusion Criteria:

* Known health problems such as cardiovascular, pulmonary or metabolic disease will be excluded.
* Pregnant females.
* Any adults found taking medications that affect endocrine or cardiovascular function will also be excluded from the study.
* Participants that exercise more than three times per week or strength train more than twice per week.
* Individuals that have poor venous access or have expressed a fear of needles or having blood taken will also be excluded.
* Cigarette smoking (current or those who quit within the previous 6 months
* Hypertension
* Diabetics
* MRI exclusion criteria must be observed: must complete a safety checklist that is designed to identify metal in your body that could pose a hazard during scanning. Some forms of metal are acceptable (e.g., dental fillings after 1970). Tattoos are generally not exclusionary, unless they have been inked with metallic dyes. All metal must be removed from your body. All female subjects, prior to scanning, are required to complete a pregnancy test. Must NOT be claustrophobic or have a history of claustrophobia
Food-effect Study of Ecopipam Pharmacokinetics

Standard food-effect study to identify the effect of food on ecopipam pharmacokinetics after administration of a to-be-marketed ecopipam tablet in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects or female subjects of non-childbearing potential
* ≥18 and ≤55 years of age
* BMI \>18.5 and \<30.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
* Subjects must be healthy, as determined by the Investigator, based on medical history, physical examination, ECG, vital signs, and standard panel of blood and laboratory tests at Screening.
* Sexually active males must use a double barrier method of contraception during the study and for at least 90 days after the last dose of study drug.
* Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.

Exclusion Criteria:

* History of significant medical illness
* Clinically significant abnormalities on screening tests/exams
* History of or significant risk of committing suicide
* Donation of plasma within 1 month prior to dosing
* Donation or significant loss of blood within 8 weeks prior to the first dosing
* Major surgery within 3 months or minor surgery within 1 month prior to admission
* Use of prohibited prescription, over-the-counter medications or natural health products
* Use of tobacco or nicotine products within 1 month prior to Screening
* Significant alcohol consumption or history of abuse
* History of drug abuse within the previous 2 years, or a positive drug screen
* History of cannabinoid use within the previous 3 months
* Positive urine drug screen, urine cotinine test, or alcohol breath test
* History of allergy to study medications
* Recent participation in a clinical research study
* Prior exposure to ecopipam
* Not suitable for study in the opinion of the Principal Investigator
A Study to Assess the Clinical Validity of Konectom™ in Adults Living With Neuromuscular Disorders

The primary objective of the study is to explore the convergent validity of smartphone-based Konectom DOAs against in-clinic standard assessments.

The secondary objectives of this study are to evaluate the test-retest reliability of smartphone-based Konectom Digital Outcome Assessments (DOAs); to determine the relationship between Konectom upper limb DOAs and conventional upper limb assessments in clinical environments; to determine the relationship between Konectom lower limb DOAs and status of ambulation in clinical environments; to evaluate group differences in smartphone-based Konectom DOAs \[self-administered at home and in-clinic\] between person with spinal muscular atrophy (PwSMA) and healthy subjects (HS); to evaluate the variability of Konectom DOAs self-administered in everyday environment in HS and PwSMA; to compare Konectom DOAs between in-clinic supervised administration versus self-assessments in everyday environment in HS, PwSMA groups; to evaluate the relationship of Konectom DOAs against patient-reported outcomes (PROs) in PwSMA and to evaluate the clinical safety of Konectom in PwSMA.


Eligibility Criteria:
Key Inclusion Criteria:

For PwSMA

* Genetic documentation of 5q SMA (homozygous gene deletion, mutation, or compound heterozygote).

For Healthy Participants

* Age group matched with SMA participants

Key Exclusion Criteria:

For PwSMA

* Change of disease modifying treatment (DMT) in the last 1 month.
* Recent history of bacterial meningitis, viral encephalitis, or hydrocephalus.
* Addiction (alcohol or another drug abuse).
* Presence of an implanted shunt for the drainage of cerebrospinal fluid (CSF) or of an implanted central nervous system (CNS) catheter.
* Hospitalization for surgery (i.e., scoliosis surgery or other surgery), pulmonary event, or nutritional support in the previous 2 months or planned within the study duration.
* Known pregnancy.

NOTE: Other protocol defined inclusion/ exclusion criteria may apply.
IMPEDE and IMPEDE-FX Embolization Plug Registry

EMBO-PMS is a prospective, multicentre, registry study of the IMPEDE and IMPEDE-FX Embolization Plug Systems


Eligibility Criteria:
Inclusion Criteria:

* Study participant is ≥18 years of age
* Study participant is considered a candidate for arterial or venous embolization of the peripheral vasculature

Exclusion Criteria:

* Study participant has an inability to provide written informed consent
* Study participant/treatment outside of the approved study device labeling, instructions for use (IFU)
* Study participant is a prisoner or member of other vulnerable population
A Study Evaluating Intravenous (IV) MOA-728 for the Treatment of Postoperative Ileus (POI) in Participants After Ventral Hernia Repair

This study will evaluate the safety and efficacy of two different dose regimens (12 milligrams \[mg\] and 24 mg) of IV MOA-728 versus placebo in shortening the time to return of bowel function in participants receiving opioid analgesia administered via patient-controlled anesthesia (PCA), and who had undergone repair of large (greater than or equal to \[≥\]10 centimeters) ventral hernias with or without a mesh prosthesis via laparotomy or laparoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, ages 18 and older.
* Scheduled for ventral wall hernia repair with general anesthesia.
* Meets the American Society of Anesthesiologists physical status I, II, or III.

Exclusion Criteria:

* Received investigational drug or procedure within 30 days of randomization.
* Women who are pregnant or lactating.
* Calculated creatinine clearance (Cockcroft-Gault glomerular filtration rate \[GFR\] formula) less than or equal to (\</=) 50 milliliters/minute (mL/min).
(mo)BETTA Trial in Transwomen for Optimization of ART

The purpose of this study is to determine the safety and tolerability of a new HIV medication, bictegravir plus emtricitabine plus tenofovir alafenamide (B/FTC/TAF, 3 HIV medications combined into one pill) in HIV-infected transgender women (TW).


Eligibility Criteria:
Inclusion Criteria:

* Self-identified transgender woman (TW)
* HIV infection
* Undetectable HIV viral load (HIV-1 RNA \<50 copies/mL) at screening and for \>/=24 weeks prior to entry.
* Current HIV treatment with FTC plus TDF or TAF and a 3rd agent.
* No changes in ART in the 12 weeks prior to screening.
* Current female hormone therapy use.
* Ability and willingness of subject to provide informed consent.

Exclusion Criteria:

* Current or planned use of prohibited medications (Phenobarbital, Phenytoin, Carbamazepine, Oxcarbazepine, Rifampin, Rifapentine, St. John's Wort, Echinacea, Dofetilide, Cisapride, Atazanavir)
* Change or initiation of lipid- and/or glucose-lowering therapy in the 12 weeks prior to entry, or planned need for such therapy during the study period.
* Current use of androgen therapy.
* Intent to significantly modify diet or exercise habits, or to enroll in a weight loss intervention during the study period.
* Anticipated need to initiate or change doses of medications with anti-inflammatory properties within the study period.
* Screening laboratory values as follows: (ANC \<500 cells/mm\^3; Hemoglobin \<10 gm/dL; Cr Cl \<30 mL/min (estimated by CKD-Epi equation); AST or ALT \>3x ULN)
* Evidence of resistance to any component of the current ART regimen (genotypic or phenotypic)
* Current use of bictegravir in another investigational setting
* Current use of other investigational agents that the participant could not receive unchanged, if needed, throughout the study period (unless approved by the study team)
* Any condition that the study investigator believes would make the candidate unsuitable for participation
National Survey on GERD Patients (Adults and Children)

To describe GERD digestive expression according to ages: - children (from 0 to 23 months) and (24 months and more)- adults (from 18 to 29 years old), (from 30 to 39 years old), (from 40 to 49 years old), (from 50 to 59 years old), (more than 60 years old)


Eligibility Criteria:
Inclusion Criteria:

* Adults : - Male or female \> or = 18 years old - With at least one GERD typical clinical sign (pyrosis and / or acid regurgitations).- Not receiving any GERD treatment within the 3 previous months.
* Children :- Male or female \< 18 years old - With GERD digestive clinical signs during the consultation (receiving treatment or not)- Whose parents or legal guardian gave oral approval to the child participation in the survey.

Exclusion Criteria:

-