cyrilzakka/clinical-trials huggingface dataset:
The Molecular Basis of Inherited Reproductive Disorders

The goal of this study is to learn more about the genes that control puberty and reproduction in humans.

All study subjects will undergo the same activities. Subjects will provide up to five tubes of blood for genetic analysis, complete a smell test, and answer questions about their health and family history.

Eligibility Criteria:
Participants must belong to one of the following categories:

* Failure to go through a normal, age-appropriate, spontaneous puberty and low sex steroid levels in the setting of low/normal gonadotropins or,
* Abnormally early development of puberty or,
* Normal puberty with subsequent development of low gonadotropin levels or,
* Evidence of a reproductive disorder with high gonadotropin levels or,
* Pre-pubertal individuals with features suggestive of hypogonadotropic hypogonadism or,
* Affected and unaffected family members of individuals that fit criteria above
Efficacy of a Short-term Sequential Therapy in Non-complicated Catheter Related Bacteremia by Methicillin- Susceptible S.Aureus.

Evaluate the efficacy of a sequential regimen of 14 days in patients with catheter-related bacteremia by S. aureus methicillin-susceptible, selected based on a pre-established clinical and microbiological criteria.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years with a minimum weight of 40 kg.
* Microbiological Isolation of S. aureus susceptible to meticillin.
* Start antibiotic treatment with drugs active against S. aureus within 72 hours from the onset of clinical manifestations.
* Women of childbearing potential, negative pregnancy test negative serum or urine or statement is not pregnant.
* Prescription prior treatment must be independent and decoupled patient inclusion in the study, corresponding exclusively to clinical practice.

Exclusion Criteria:

* Polymicrobial bacteremia.
* Neutropenic patients.
* Patients addicted to intravenous drugs.
* Patients with malignancies with expected survival less than 6 months.
* Severe allergy to beta-lactams or fluoroquinolones.
* Creatinine clearance \<20ml/min.
* Need for hemodialysis, peritoneal dialysis or plasmapheresis.
* Clinical signs of deep infection in the first five days of treatment (mucocutaneous lesions suggestive of IE, embolic events, suppurative thrombophlebitis.
* Predictors of bacteremia complicated:
* Positive blood cultures for 48-96 hours of starting treatment antistaphylococcal
* Clinical Instability
* Signs of sepsis or persistent fever at day 4 of treatment
* Existence of valvular or vascular prosthetic joints, vascular catheter not removed within three days
* Heart disease predisposing to endocarditis.
* Patients presenting diagnosis concomitant infection by another organism.
* Pregnant or breast-feeding.
* Patients with epilepsy.
* Patients with a history of tendon disorders related to fluoroquinolone administration.
* Not have signed informed consent.
The Feasibility and Clinical Utility of the Use of Virtual Reality for the Management of Pediatric Dental Anxiety

The use of virtual reality (VR) in pediatric healthcare settings helps to reduce children's pain and anxiety. However, this technology has not been used consistently in pediatric dentistry. Consequently, the goal of this study is to investigate the effectiveness of using a Virtual Reality headset as a distraction technique during dental procedures in children and identify patient and clinician's opinions regarding its use.

This study incorporates a single-site, randomized clinical trial design with two paralleled study groups. One group will receive dental treatment following regular standard of care of behavior management while the second group will receive dental treatment using a Virtual Reality distraction headset. Patients in both groups will complete a questionnaire to assess their perception of pain and anxiety before and after the intervention, as well as their satisfaction with the dental treatment. The dentist providing the treatment will also report their observations relating to patient behavior during dental treatment.


Eligibility Criteria:
Inclusion Criteria:

* Children aged between 6 and 12 years and their accompanying parent/legal-guardian.
* Children scheduled for one of the following procedures: restorative treatments (amalgam, composite or stainless-steel crowns), pulp therapy and extractions
* Children that can understand and speak French or English.

Exclusion Criteria:

* Children diagnosed with a cognitive, auditory, or cognitive impairment preventing them from interacting with the VR game.
* Children diagnosed with epilepsy or any other condition preventing them from playing the VR game.
* Children requiring urgent dental care
* Children requiring dental treatment with conscious sedation (i.e. nitrous oxide inhalation and/or oral sedation with benzodiazepines)
Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo

This was a single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study designed to evaluate the relative abuse potential of crushed EMBEDA® compared to morphine sulfate CR tablets and placebo in healthy male and female, non-dependent, recreational opioid users. An appropriate dose of morphine sulfate CR (i.e., 30 mg, 60 or 90 mg) was to be selected during Part A of the study (Dose Selection Phase). Each subject participated in the study for up to (approximately) 16 weeks and was confined in the clinic for a total of up to 12 nights.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects 18 to 55 years of age, inclusive.
* Subject is a recreational opioid user who is NOT dependent on opioids based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria and the Naloxone Challenge. A recreational opioid user is defined as use of opioids for non-therapeutic purposes (i.e., for psychoactive effects) on at least 10 occasions within the last year and at least once in the 12 weeks before the Screening Visit (Visit 1).
* Subjects must have experience with intranasal drug administration, defined as intranasal use on at least 3 occasions within the last year prior to the Screening Visit.

Exclusion Criteria:

* Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine), as assessed by the Investigator using the DSM IV-TR criteria.
* Has participated in, is currently participating in, or is seeking treatment for substance- and or alcohol-related disorders (excluding nicotine and caffeine).
* Has any condition in which an opioid is contraindicated; e.g., significant respiratory depression, acute or severe bronchial asthma or hypercarbia, or is suspected of having paralytic ileus.
* Allergy or history of hypersensitivity to morphine sulfate, other opioids, naltrexone hydrochloride, naloxone, and/or lactose.
* History or current clinically significant neurological, cardiovascular, renal, hepatic, endocrine, gastrointestinal, hematologic, or metabolic disease as evaluated by the Investigator.
* History or current pulmonary disease including asthma, chronic obstructive pulmonary disease, exercise-induced asthma, bronchitis, and obstructive sleep apnea.
Neural Mechanisms of Obsessive-compulsive Disorder (OCD) Treatment Failure

The aim of this study is to understand why patients with obsessive-compulsive disorder (OCD) fail in therapy.

To understand the neural mechanisms involved in exposure therapy that support success and clinical improvement in order to improve therapy outcomes for OCD patients.

A course of therapy is recommended for individuals with obsessive-compulsive disorder (OCD). It is usually a type of cognitive behavioural therapy (CBT) with exposure and response prevention (ERP).

In this study the investigators assess patients pre-therapy and post-therapy evaluating symptom severity (measured by the Y-BOCS) and decision-making (measured by online questionnaires and computer-based behavioural tasks).

To examine how decisions are formed in patients undergoing OCD CBT, how behaviour changes after a non-pharmacological therapy module and how it is associated to the alleviation of OCD symptoms.

The study, which will recruit 90 patients, is based at University College London - Wellcome Centre for Human Neuroimaging. This study is a part of the Cognitive and Neural Networks in Psychiatry (CNNP) study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of obsessive-compulsive disorder (OCD)
* Fluent in written and spoken English
* Normal/corrected to normal vision
* Expecting to start OCD therapy

Exclusion Criteria:

* Autism spectrum disorder, psychosis, schizophrenia, addiction, substance abuse, bipolar, hoarding, or Tourette disorder
* Hearing conditions: tinnitus, ear inflammation, hearing sensitivity, hearing loss, requires hearing aids
* Colour blindness
* Severe learning disabilities
US Guided Erector Spinae Plane Block in Breast Cancer Surgery: Analgesia, Spread and Immunomodulation

Prospective interventional study

The aim of the present study is to evaluate the effect of US guided unilateral ESPB using different volumes of local anaesthetics on analgesic efficacy, dermatomal spread and immunomodulation in breast cancer surgery.

The primary outcome is the analgesic efficacy of the different local anaesthetic volumes of ESPB.

The secondary outcomes are the dermatomal dye spread and sensory coverage, immunomodulation and complications in breast cancer surgery.

Immunomodulation will be assessed by measuring Natural killer cells cytotoxicity.

Eligibility Criteria:
Inclusion Criteria:ASA physical status 1 or 2 scheduled for mastectomy under the effect of General Anaesthesia

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Exclusion Criteria:

1. Patient refusal.
2. Allergy or contraindication to any of the studied medications or anaesthetic agents.
3. Chronic opioid analgesic use.
4. Pregnancy.
5. Morbid obesity (BMI ≥ 40 kg/m2).
6. Scoliosis or any vertebral anomalies or previous spinal surgeries.
7. Infection at the site of injection or any other contraindication for regional anaesthesia.
8. Duration of surgery more than 90 minutes.
9. Renal impairment.
Yoga for Patients With Rheumatoid Arthritis

The purpose of this study is to investigate the effects of a yoga program based on "Yoga in daily life system" in patients with rheumatoid arthritis.

The investigators want to explore whether this program will improve health-related quality of life and psychological well-being in patients. In addition they want to explore its potential positive modulation of the immune system.

Rheumatoid arthritis (RA) is a chronic disabling inflammatory disease that substantially impacts health-related quality of life (HRQOL) of patients. In addition to pain, fatigue and physical disability the disease also affects psychological health. Yoga, a mind-body therapy, integrates physical exercises with relaxation and meditation. Published data suggest its beneficial effects on both physical and mental health in various chronic conditions. The true biological mechanism underlying these effects is not well known. Recent research suggests potential modulation of the immune system and inflammation-related gene expression changes.

Hypothesis: Yoga program based on Yoga in daily life system has positive impact on clinical and biologic outcomes in RA patients.

Aims: To determine the impact of a 12-week yoga program on measures of psychological distress, HRQOL, fatigue, pain, disease activity, levels of circulating inflammatory markers and pro-inflammatory gene expression.

Materials and methods: 50 RA patients, aged 18-65 years, on stable standard pharmacological treatment will be randomly assigned to a 12-week yoga intervention (based on "Yoga in daily life system") or arthritis-education control. Self-administered questionnaires will be used to assess quality of life and psychological well-being of the patients. Blood samples will be collected for measurement of inflammatory markers and expression of a set of pro-inflammatory genes. Disease activity will be assessed by DAS28CRP score. The patients will be assessed on baseline, post-treatment and at 3 months follow-up.

This research will provide information on potential efficacy of yoga program in improving physical and psychological outcomes in persons with RA and explore its influence on immunological system.

Eligibility Criteria:
Inclusion Criteria:

1. ACR/EULAR 2010. classification criteria for rheumatoid arthritis (RA)
2. disease activity measured by DAS28CRP\< 5.1
3. patients on stable dose of disease-modifying antirheumatic medications,non-steroidal anti-inflammatory drugs or low-dose glucocorticoids for the last 3 months

Exclusion Criteria:

1. significant co-morbidity (active malignant disease, symptomatic ischemic heart disease or heart failure, severe lung disease, uncontrolled thyroid disease, neurological disease that impairs mobility) that is more limiting than RA
2. history of drug or alcohol abuse
3. recent injury/ or surgery
4. regular practice of yoga or similar technique in the last 6 months or currently engaged in a structured exercise program for \>=2 times weekly, patients that are currently engaged in physical therapy
5. pregnant or planning pregnancy
MSI-1256F (Squalamine Lactate) in Combination With Verteporfin in Patients With "Wet" Age-Related Macular Degeneration (AMD)

Age-Related Macular Degeneration (AMD) is a degenerative disease of the retina that causes a progressive loss of central vision. AMD is the leading cause of legal blindness among adults age 50 or older in the Western world. AMD presents in two different types - "dry" and the more severe "wet" form. Wet AMD is caused by the growth of abnormal blood vessels in the macula.

Squalamine lactate is an investigational drug that may prevent the growth of these abnormal blood vessels. This study will test the safety and efficacy of Squalamine when administered with verteporfin therapy in patients with "wet" AMD.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of "wet" age-related macular degeneration

Exclusion Criteria:

* Prior treatment for "wet" age-related macular degeneration
Effect of Total Intravenous Anesthesia and Balanced Anesthesia on Postoperative Lung Function

The aim of the study is to investigate the effects of total intravenous anesthesia (TIVA; propofol, remifentanil) and balanced anesthesia (BAL; induction with propofol and fentanyl; maintenance of anesthesia with sevoflurane and nitrous oxide) on pulmonary function 30 minutes after emergence from the general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2
* BMI normal

Exclusion Criteria:

* lung disease
* Nicotine abuse
Platelet-Rich Fibrin in Intraoral Soft Tissue Regeneration

Determine if the use of platelet rich fibrin (PRF) improves the rate and quality of healing for intraoral mucosal and epithelial soft tissue defects.


Eligibility Criteria:
Inclusion Criteria:

* Three categories of patients will be included in this study:

  1. Osteoradionecrosis (ORN) or medication related osteonecrosis of the jaw (MRONJ) patients who present to clinic with exposed bone and no clinical sign of infection.
  2. Patients having an excisional biopsy in clinic performed under local anesthesia resulting in a defect that cannot be easily repaired without compromising normal anatomy or function. These situations include excisions which would result in primary closure under tension or with distorted anatomy, require a local flap, or require healing by secondary intention.
  3. Patients presenting to the post-operative clinic with intraoral surgical wound dehiscence or an intraoral surgical wound healing by secondary intention.

     Exclusion Criteria:
* Patients under 18 years of age.
* Patient's unable to participate in blood draw either due to medical compromise, inability to tolerate the procedure, or inability of the physician to successfully draw the blood at the time of appointment.
Advancing Adolescent Screening and Brief Intervention Protocols in Primary Care Settings

This proposed study tests the effectiveness and examines the implementation of screening and brief intervention techniques to delay initiation and reduce substance use among adolescents accessing medical care in Federally Qualified Health Care settings with a computer-facilitated intervention. The primary hypothesis is that participants in the intervention groups will be more likely to cease or reduce substance use at follow-up compared to clients in the treatment as usual condition.

The aims of the proposed 5-year study are threefold: (1) To examine the effectiveness of a computer-facilitated Screening and Brief Advice (cSBA) to reduce initiation and substance abuse among adolescents in a novel setting; (2) To examine the comparative effectiveness of adding a Brief Intervention and Referral to Treatment component to the cSBA intervention among adolescents in these centers; (3) To examine factors facilitating and inhibiting the implementation of SBIRT-type procedures with adolescents in FQHCs.

Eligibility Criteria:
Inclusion Criteria:

* 12-18 year old patients seeking care at the primary care participating sites

Exclusion Criteria:

* Unable to read and understand English
* Medically unstable
* Unavailable for follow-up
Physical Therapy Following Total Hip Arthroplasty

130 patients undergoing primary unilateral total hip arthroplasty through anterior approach were enrolled and randomized into one of two groups. One group received standard of care clinic-based physical therapy postoperatively (clinic PT) while the other group underwent progressive home-based exercises to do after surgery (home PT). Patient surveys with Hip Osteoarthritis Outcome Scores (HOOS) and SF12v2 scores for both groups were obtained before surgery as well as 6, 14, and 24 weeks postop. Patients had the option to crossover into the other study group at their 6-week follow-up visit.


Eligibility Criteria:
Inclusion Criteria:

* scheduled to undergo primary unilateral anterior total hip arthroplasty for the treatment of arthritis under the care of the Principal investigator
* available for follow ups postoperatively

Exclusion Criteria:

* Age \<18 or \> 75
* Preoperative BMI ≥ 40
* Revision (i.e., non-primary) THA procedures
* Patients who have undergone THA in contralateral hip within the past 6 months
* Patient is scheduled for or anticipating THA on contralateral limb within 6 months
* Patients with an active infection (at the time of screening through surgery, as this is a surgical contraindication)
* Current co-morbidities such as alcohol or drug addiction, and/or mental disorders could potentially interfere with study participation
* Cognitive deficit or significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting
* History of severe osteoporosis, metabolic bone disease, radioactive bone disease, or tumor in the bone surrounding the hip joint
* History of significant neurological and/or musculoskeletal disorders that may adversely affect gait after THA
* History of inflammatory hip arthritis
* History of septic hip arthritis in affected hip
* Patients requiring discharge to a rehabilitation center, skilled nursing facility, long-term care center, or convalescent home
* Non-English speaking
* Unable to give informed consent
* Currently enrolled in another therapeutic study for THA
A Placebo Controlled Trial of the Dopamine D-2 Receptor Agonist Ropinirole in Treatment of 60 Patients With Refractory Bipolar Depression.

We hypothesize that depressed patients who have not responded to their current antidepressant medication will respond to the addition of ropinirole to their current regimen at a rate better than placebo.

Most pharmacologic treatments of depression rely on serotonergic and/or noradrenergic mechanisms. Yet, evidence both from animal studies and from human trials suggests a role for dopaminergic pathways and particularly for dopamine D2-like receptors in the treatment of depression. In recent years, two new selective agonists of dopamine D2-like receptors have come into clinical use for the treatment of parkinsonism. Preliminary evidence suggests that these drugs might be useful as antidepressants. We are testing whether one of these agonists, ropinirole, is an effective augmentation strategy in depressed patients in a double-blind, randomized, controlled trial. We are recruiting unipolar and bipolar patients who remained depressed (modified Hamilton Depression Rating Scale score greater than 16) despite at least 4 weeks of treatment with an adequate dose of antidepressant medication. Patients receive either 2mg of oral ropinirole or placebo twice daily added on to their current medication and are evaluated weekly over 7 weeks and are assessed weekly using two depression rating scales.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV Major Depression OR Bipolar I or II Disorder - Currently Depressed
* One month of a stable, adequate dose of antidepressant medication
* Bipolar patients must have a mood stabilizer
* At least 18 years old
* Modified HDRS-21 more than 16 (Scores reverse vegetative symptoms.)
* Informed Consent

Exclusion Criteria:

* CVA
* Antipsychotic Medication
* Drug or Alcohol Abuse
* Active Suicidality
* Rapid Cycling Bipolar Disorder
* Neurologic or Dementing Illness
* Psychosis
* Parkinsonism
* Pregnancy
Fructose Supplementation in Carriers for Hereditary Fructose Intolerance

This study aimed to examine metabolic response to a short-term fructose enriched diet in carriers for hereditary fructose intolerance compared to controls. Effects of fructose coffees will be assessed in 7 healthy volunteers and 7 subjects with heterozygous mutation for ALDOB gene in a randomized, controlled, crossover trial.

A high fructose intake also increases blood lactate and uric acid concentrations. It has been proposed that uric acid may contribute to insulin resistance by impairing endothelium-dependent vasodilation, promoting pro-inflammatory effects and dyslipidemia by activating de novo lipogenesis.

These consequences of fructose overconsumption may be even more marked in individuals with hereditary alterations in fructose metabolism. Indeed, individuals with hereditary fructose intolerance (HFI), due to biallelic mutations in the gene coding for aldolase B (ALDOB), may develop acute, life-threatening manifestations when exposed to fructose. Heterozygous carriers of ALDOB mutation are quite common in the general population, with a predicted frequency ranging between 1:55 and 1:120. Few studies have examined the effect of fructose ingestion in heterozygotes subject for HFI. Heterozygous carriers are generally considered to have normal fructose metabolism since a \~ 50% level of aldolase B activity is presumed to be sufficient for adequate function. However, heterozygous carriers were reported to have enhanced uric acid responses to large intravenous and/or oral fructose loads.

Investigators hypothesized that heterozygous carriers may also have mild defects of fructose metabolism and/or a larger increase in cardiometabolic risk factors than the normal population after ingestion of moderate amounts of fructose.

Eligibility Criteria:
Inclusion Criteria:

* Case subjects: Heterozygous carriers for ALDOB mutation confirmed by molecular analysis
* Control subjects: healthy individuals matched for weight and age to subjects

Exclusion Criteria:

* Fasting glucose \> 7.0 mmol/L
* Fasting triglycerides \> 4.0 mmol/L
* Chronic renal insufficiency (eGFR \< 50 ml/min)
* Drugs
* Women who are pregnant or breast feeding
* For women: lack of safe contraception
* Alcool consumption \> 30g/d
* Inability to discern