cyrilzakka/clinical-trials huggingface dataset:
A Study to Determine the Bioavailability and Food Effect of a Single TAK-935 Dose in Healthy Participants

The purpose of this study is to assess the relative bioavailability (BA) of 300 milligram (mg) TAK-935 tablets compared to 300 mg of TAK-935 solution and to determine the effect of food on the BA of TAK-935 300 mg tablets in healthy adult participants.

The drug being tested in this study is called TAK-935. The study will look at the relative BA of TAK-935 300 mg tablets compared to a TAK-935 300 mg oral solution and will assess the effect of food on the BA of TAK-935 300 mg tablets in healthy adult participants.

The study will enroll approximately 9 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the 3 treatment sequences:

* TAK-935 (300 mg Tablets Fed + 300 mg Tablets Fasted + 300 mg Solution Fasted)
* TAK-935 (300 mg Tablets Fasted + 300 mg Solution Fasted + 300 mg Tablets Fed)
* TAK-935 (300 mg Solution Fasted + 300 mg Tablets Fed + 300 mg Tablets Fasted)

Administration of each dose will be separated by a washout period of at least 3 days. Participants will be asked to take single dose of TAK-935 tablet or oral solution on Day 1 of each Intervention Period.

This single center trial will be conducted in the United States. The overall time to participate in this study is 39 days. Participants will remain confined to the clinic from Day 1 of Intervention Period 1 to Day 3 of Intervention Period 3 and will be contacted by telephone 30 days after last dose of TAK-935 for a follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Weighs at least 45 kilogram (kg) and has a body mass index (BMI) from 18.0 to 30.0 kilogram per square meter (kg/m\^2), inclusive at Screening and Day -2.

Exclusion Criteria:

1. Has received TAK-935 in a previous clinical study or as a therapeutic agent.
2. Has a history of any psychiatric disorder as diagnosed utilizing Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) criteria.
3. Has any lifetime history of drug abuse (defined as any illicit drug use) or any lifetime history of alcohol abuse prior to the screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. One unit is equivalent to a half-pint of beer or a single measure of spirits or 1 small glass of wine.
4. Has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1.
5. Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody at Screening or a known history of human immunodeficiency virus infection.
6. Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-In Day -1. Cotinine test is positive at Screening or Check-In (Day -1).
7. Has poor peripheral venous access.
8. Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day 1 of Period 1.
Fluoxetine vs Aripiprazole Comparative Trial (FACT)

We are conducting a randomized, 24-week, double-blind study, comparing fluoxetine with aripiprazole in 48 patients with attenuated positive symptoms at a level of at least moderate severity.

To Compare Fluoxetine and Aripiprazole on All-cause Discontinuation/Need to Add Another Psychiatric Medication, Symptomatic Improvement, and Adverse Effects

Eligibility Criteria:
Inclusion Criteria:

* consent obtained from patients and their parents (assent for patients under 18);
* age 12-25 years (inclusive);
* English-speaking;
* at least one positive (Scale A) SOPS score of 3-5, i.e., moderate, moderately severe or severe.

Exclusion Criteria:

* lifetime diagnosis of an Axis I psychotic disorder, including: schizophreniform disorder, schizophrenia, schizoaffective disorder, bipolar disorder, or major depression with psychotic features;
* current psychosis (any positive symptom SOPS score of 6, i.e., extreme);
* current diagnosis of Major Depressive Disorder, single episode or recurrent, severe without psychotic features;
* current stimulant treatment;
* history of neurological, neuroendocrine or other medical condition known to affect the brain;
* any significant medical condition that contra-indicates treatment with either aripiprazole or fluoxetine;
* past or current substance dependence; sunstance abuse within the last 4 weeks;
* IQ \< 70.
Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism

Bilateral dispensing clinical trial of stenfilcon A against etafilcon A for astigmatism.

CooperVision is evaluating the clinical performance of an FDA cleared silicone-hydrogel lens material stenfilcon A (test) compared to etafilcon A for Astigmatism lens (control) when worn on a daily wear basis over one (1) week in a randomized, bilateral, cross-over, dispensing study.

Eligibility Criteria:
Inclusion Criteria:

* Is at least 17 years of age for Canada and 18 years of age for the USA and has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Is an adapted soft contact lens wearer;
* Requires a spherical contact lens prescription between -1.00 to -6.00 inclusive in each eye
* Has spectacle astigmatism: -0.50 to -1.50D (Diopter) cylinder (Axis: 90±20, 180±20 in both eyes);
* Willing to wear contact lens in both eyes for at least 8 hours per day, 7 days per week;
* Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye;
* To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit as acceptable.

Exclusion Criteria:

* Is participating in any concurrent clinical or research study;
* Has any known active\* ocular disease and/or infection;
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
* Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
* Is pregnant, lactating (by verbal confirmation at the screening visit);
* Is aphakic;
* Has undergone refractive error surgery
Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas

The purpose of this study is to assess the 6-month survival rate and safety of talabostat and gemcitabine in patients with stage IV adenocarcinoma of the pancreas.


Eligibility Criteria:
Inclusion Criteria:

* Men or women age ≥18 years
* Histologically confirmed metastatic (stage IV) adenocarcinoma of the pancreas
* Measurable disease defined per RECIST
* Karnofsky Performance Status ≥50
* Expected survival ≥12 weeks
* Provide written informed consent

Exclusion Criteria:

* CNS metastases
* Prior treatment with other chemotherapy for pancreatic cancer unless used as a radiosensitizer
* Radiation therapy to \>25% of the bone marrow
* Clinically significant laboratory abnormalities
* Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
* The need for chronic (i.e., \>7 days) oral or intravenous corticosteroid therapy with \>10mg/day prednisone equivalents
* Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
* Patients who are within 28 days of radiation therapy, biologic therapy, immunotherapy, or other investigational medication. All side effects of prior treatment must have resolved at study entry.
* Pregnancy or lactation
Intravenous Nalbuphine for Prevention of Intrathecal Morphine-induced Nausea and Vomiting in Patients Undergoing Cesarean Section: A Double-blind, Randomized Controlled Trial.

We study efficacy of iv nalbuphine in prevention of intrathecal morphine-induced nausea and vomiting in patients undergoing cesarean section.

IV nalbuphine has been proved to help prevent intrathecal morphine-induced pruritus in some studies but results in nausea vomiting prevention have not been well studied. In Thailand, most caesarean section is done under spinal anesthesia with intrathecal morphine, proving that iv nalbuphine is effective would be beneficial for our population. This study aims to see whether 4 mg of nalbuphine is effective in reducing incidence of intrathecal morphine-related nausea vomiting in parturient who underwent C-section under spinal anesthesia with 0.2 mg of intrathecal morphine.

Eligibility Criteria:
Inclusion Criteria:

* Elective cesarean section under spinal anesthesia
* age \> 18 years

Exclusion Criteria:

* Patients with known allergy to medications used in this study (nalbuphine, bupivacaine or morphine)
* Patient with medical conditions which spinal anesthesia is contraindicated ie. heart diseases, renal or hepatic impairment, obesity \>=100 kilograms
* Patients with history of postoperative nausea and vomiting (PONV) or motion sickness who may have preexisting risk factors for PONV
* Patient with known history of drug abuse
* Unwilling to participate in the study
Feasibility of the Multiple Sclerosis Performance Test in Participants With Multiple Sclerosis

The primary objective is to evaluate the feasibility of the Multiple Sclerosis Performance Test (MSPT) in a clinical care setting when used by participants with Multiple Sclerosis (MS).


Eligibility Criteria:
Key Inclusion Criteria:

* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with applicable participant privacy regulations
* Diagnosis of MS, including Clinically Isolated Syndrome
* Ability to understand the audio and visual instructions for the test modules
* Visual function, based on the investigator's clinical judgement that does not preclude an ability to interact with the Multiple Sclerosis Performance Test (MSPT).

Key Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Participants younger than 18 years of age, unless their parent or legal guardian provides the required signed and dated informed consent and authorization to use confidential health information and the participant provides assent in accordance with national and local subject privacy regulations

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
OFC rTMS in Emotionally Unstable and Depressed Patients

Treatment of depression with conventional transcranial magnetic stimulation (rTMS) has shown high evidence using high-frequency left dorsolateral prefrontal cortex (DLPFC) stimulation. Recently, it could be demonstrated that treatment of the right orbitofrontal cortex may be effective in patients who did not respond to conventional DLPFC rTMS. Orbitofrontal cortex (OFC) seem to be involved in the etiopathology of emotionally instable personality disorders. Thus, the present one-arm trial is a pilot study investigating if OFC rTMS is feasable, tolerable and effective.


Eligibility Criteria:
Inclusion Criteria:

* ICD-10: F60.30 or F60.31
* depressive symptoms and HAMD-21 score of at least 7
* sex: female and male
* residence in Germany and German speaking
* written informed consent

Exclusion Criteria:

* meeting the contraindications for transcranial magnetic stimulation (electric devices or metal implants in the body, e.g. cardiac pace maker, insulin pump)
* neurological disorders (e.g. cerebrovascular events, neurodegenerative disorder, epilepsy, brain malformation, severe head trauma)
* participation in another study parallel to the Trial
* other mental or somatic illness which is not compatible with participation according to the principal investigator
* pregnancy or breastfeeding period
* psychiatric confinement
A Retrospective, Observational, Non-interventional Trial to Assess Eculizumab Treatment Effect in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)

The objective of this retrospective trial is to assess safety and efficacy of eculizumab in aHUS patients treated outside of an Alexion-sponsored controlled clinical trial.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients of any age who have been diagnosed with aHUS.
2. Received at least one dose of eculizumab for the treatment of aHUS between 2007 and 2009 outside of an Alexion sponsored controlled clinical trial.

Exclusion Criteria:

1. Patients who have participated or are currently participating in a controlled clinical trial of eculizumab
MR Quality + Diagnostic Performance for CHC Diagnosis - Gadoxetic Acid, Gadoteric Acid and P03277 Comparison

Compare diagnostic MRI performance of gadoteric acid, gadoxetic acid and P03277 for suspected CHC nodules less than 3 cm, using LIRADS criteria


Eligibility Criteria:
Inclusion Criteria:

* Patients who had all three MRI scans as part of the diagnosis of the same suspected CHC lesion(s)
* Reference diagnosis obtained for suspected CHC nodules by a diagnostic algorithm taking into account histology, imaging and follow-up

Exclusion Criteria:

* Delay between first MRI and 3rd MRI greater than 3 months
Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis

The purpose of this study is to better understand multiple sclerosis (MS) in children and adolescents, to learn if it differs from adult MS and to investigate if genes or environmental exposures or a combination of both put children and adolescents at risk for getting MS.

The overall goal of this project is to determine whether well-established environmental and genetic risk factors for adult onset MS play an important role in susceptibility to pediatric-onset MS. Our study design is based on the hypothesis that genetic influences, specifically variation at HLA-DRB1 and other confirmed non-MHC MS loci, as well as environmental exposures including EBV infection and tobacco smoke, contribute to disease risk. In addition, we will also examine the relationship between serum levels of 25(OH) vitamin D3 and prior vitamin D status, and risk for pediatric onset MS. Finally, we will investigate whether specific G x E, and other multivariable relationships influencing risk exist for pediatric-onset MS. There are 16 collaborating sites other than UCSF that will enroll cases and controls for this study.

Eligibility Criteria:
Children are eligible for this study as cases if:

* They have MS or clinically isolated syndrome (CIS):

  * MS: As defined by the 2010 McDonald criteria for diagnosis of MS (Polman 2010),
  * CIS: A first demyelinating event indicating high risk for MS (i.e., one clinical event involving the spinal cord, the optic nerve, the brainstem or cerebellum, or occasionally the hemispheres) and at least 2 silent T2 bright areas on a brain or spinal cord MRI (at least one must be in the brain); AND
* They are three years of age or older; AND
* Disease onset occurred before 18 years of age.

Patients are not eligible for study participation if:

* Disease onset occurred more than 4 years prior to the opportunity to enroll; OR
* They have had an organ transplant; OR
* They are known to have neuromyelitis optica (NMO).

Children are not eligible to participate as pediatric controls if:

* They are two years of age or younger; OR
* They are 22 years of age or older; OR
* They are known to have MS or another demyelinating disease (for example, neuromyelitis optica or acute disseminated encephalomyelitis); OR
* They have a biological family member who has been enrolled as a control; OR
* They have an immediate, biological family member (parent/sibling) who has been diagnosed with MS; OR
* They have an autoimmune disorder (except asthma or eczema); OR
* They have had an organ transplant; OR
* They have a chronic neurological condition with major disability (this does not include, for example, migraine, controlled seizures, and mild learning disabilities such as ADD or ADHD).
Delirium in Children Undergoing Stem Cell Transplantation

Children undergoing stem cell transplants are at risk for delirium, a temporary change in thinking and behavior. This study will define delirium rates, risk factors, and outcomes. Our eventual goal is to reduce delirium in this population.

Delirium -- defined as an acute change in awareness and cognition that occurs in the setting of an underlying illness -- is a common complication of hematopoietic stem cell transplantation (HSCT) in adults, with associated morbidity and mortality. This has never been studied in children, where risk factors may vary substantially from adults. The objectives of this study are: to define the epidemiology of delirium, and measure its effect on outcomes.

This prospective longitudinal cohort study will prospectively establish the incidence of delirium in 1000 children in the peri-transplant period, and identify modifiable risk factors that predispose to delirium development. This study will also define the effect of delirium on important clinical outcomes, including neurocognitive function. This study will be executed by a research consortium of five leading pediatric oncologic transplant centers in North America, in collaboration with the leading pediatric delirium research group in the United States.

This innovative proposal will leverage the combined experience of the pediatric delirium and HSCT teams to expand urgently needed delirium research into a unique and unstudied population. By reducing delirium rates, outcomes after pediatric HSCT can be optimized.

Eligibility Criteria:
Inclusion Criteria:

* Age 0-21 years old
* Admitted for purpose of stem cell transplant

Exclusion Criteria:

* Age \>21 years old
* Admitted for reason other than stem cell transplant (example: late post-transplant complications).
Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery

This is a placebo controlled randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years or older as well as willing and able to provide informed consent
* Patients must be undergoing a scheduled surgery for pelvic organ prolapse or urinary incontinence
* Standard postoperative plan must include admission to the hospital with foley catheterization overnight the night after surgery, and planned removal of foley catheter and active voiding trial on postoperative day 1.

Exclusion Criteria:

* Patient unable or unwilling to provide informed consent
* Severe allergy to sulfa drugs
* Known allergy to tamsulosin or another alpha antagonist medication
* History of urinary retention
* Planned bladder catheterization greater than 24 hours after surgery
* Current use of alpha antagonist medication for hypertension
* End stage renal or liver disease
Study on Primary Care Health Service Utilization in Hong Kong

The aim of this study was to find out the utilization rate and pattern of primary health care services, and the process and outcomes of primary care consultations of the general population in Hong Kong, and whether having a family doctor would make any difference.

The study objectives were to determine

1. the rates and pattern of utilization of different primary health care services and self-care
2. Patient self-reported outcomes (global rating on change in health, satisfaction and patient enablement) of primary care consultations;
3. the process of care in consultations including drug and non-drug managements, investigations, preventive care and referrals;
4. the effect of having a regular family doctor on service utilization rate and pattern, health promotion practice, and process and outcomes of primary care consultations.

Study Design: A Cross-sectional general population survey and a longitudinal study (12-weeks follow up)

Method: Two phases, corresponding to Summer and Winter, respectively, of cross-sectional telephone survey on the Hong Kong general population using a structured questionnaire to collect information on the choice primary care doctors, illness rates, primary care service utilization rates and self-reported process and outcomes of consultations. A longitudinal study for 12 weeks was carried out on a sub-sample of the cross-sectional study subjects to collect data to cross-validate cross-sectional data. Univariate and multivariate regression analyses were used to determine whether there was any difference in service utilization rates, process and outcomes among people using different types of primary care doctors.

Eligibility Criteria:
Inclusion Criteria:

* Written consent to study

Exclusion Criteria:

* Non-residential numbers
* Inability to communicate in Cantonese, Putonghua or English
* Refusal to telephone interview
* No contact after 5 attempts
A Clinical Investigation of the Taperloc® Microplasty™ Hip System

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Taperloc® Microplasty™ Hip System.


Eligibility Criteria:
Inclusion Criteria:

* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
* Rheumatoid arthritis.
* Correction of functional deformity.
* Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
* Revision of previously failed femoral head resurfacing component

Exclusion Criteria:

Absolute contraindications include:

* infection,
* sepsis, and
* osteomyelitis.

Relative contraindications include:

* uncooperative patient or patient with neurologic disorders who are incapable of following directions,
* osteoporosis,
* metabolic disorders which may impair bone formation,
* osteomalacia,
* distant foci of infections which may spread to the implant site,
* rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
* vascular insufficiency, muscular atrophy, or neuromuscular disease.