cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study to Learn if SEP-363856 Has Physical Dependence in Adults With Schizophrenia

A Clinical Study to learn if SEP-363856 has physical dependence in adults with schizophrenia. This study will be held in approximately 6 study sites in the United States. It will be accepting male and female participants age 18 years to 65 years. Participation will be up to approximately10 weeks.

This is a double-blind, placebo-controlled, randomized withdrawal study comparing abrupt discontinuation of SEP-363856 (SEP-363856 switched to placebo) to continuous SEP-363856 treatment in male and female adult subjects with schizophrenia.

Eligibility Criteria:
Inclusion Criteria: (this list is not all inclusive)

* Male or female subject between 18 and 65 years of age (inclusive) at the time of informed consent.
* Subject meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a primary diagnosis of schizophrenia as established by clinical interview (using the DSM-5 as a reference and confirmed using the Structured Clinical Interview for DSM-5, Clinical Trials Version \[SCID-CT\]).
* Subject must have a Clinical Global Impression-Severity Scale (CGI-S) score ≤ 4 (normal to moderately ill) at Screening and Day 1.
* Subject must have a PANSS total score ≤ 80 at Screening and a score of ≤ 4 on the following PANSS items at Screening: P7 (hostility) and G8 (uncooperativeness).
* Subject has been taking an antipsychotic for at least 6 weeks prior to Screening and has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes may be permitted) for at least 6 weeks prior to Screening.

Exclusion Criteria: (this list is not all inclusive)

* Subject has a DSM-5 diagnosis or presence of symptoms consistent with a current DSM-5 diagnosis other than schizophrenia.
* Subject has attempted suicide within 6 months prior to Screening.
* Subject answers "yes" to "Suicidal Ideation" Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening (ie, in the past 1 month) or at any subsequent C-SSRS assessment prior to dosing (ie, since last visit).
* Subject is at significant risk of harming him/herself or others (passive or active) according to the Investigator's judgment.
Feasibility of Integrated Care of Depression in Primary Care Pathways

This protocol is a feasibility study of an integrated primary care pathway for patients suffering from difficult-to-treat depression. 50 patients will be recruited and followed for two years.


Eligibility Criteria:
Inclusion Criteria:

* age 18-65 years
* Good understanding of french language
* Major depressive disorder based on DSM-V criteria
* MADRS \> 19
* FAilure of two antidepressants during 6wks at standard minimal dose

Exclusion Criteria:

* Pregnancy or lactating
* People under tutelage
* bipolar disorder
* no health insurance
* neurological disorders
* contra-indication to physical activity
* high suicidal risk
* first degree history of bipolar disorder, schizophrenia, autism spectrum disorder
Imatinib in Systemic Sclerosis

Systemic sclerosis (SSc) is an autoimmune disease characterized by fibrosis of the skin and internal organs and widespread vasculopathy. Patients with SSc are classified according to the extent of cutaneous sclerosis: patients with limited SSc have skin thickening of the face, neck, and distal extremities, while those with diffuse SSc have involvement of the trunk, abdomen, and proximal extremities as well. The disease course varies depending on the subtype of SSc. However, common features that result in significant morbidity and mortality, in addition to cutaneous fibrosis, include Raynaud's phenomenon and digital ulcerations, interstitial lung disease (ILD), and pulmonary arterial hypertension (PAH). Current therapeutic options for patients with SSc and these clinical manifestations have shown limited efficacy.

Imatinib antagonizes specific tyrosine kinases that mediate fibrotic pathways involved in the pathogenesis of SSc, including c-Abl, a downstream mediator of transforming growth factor (TGF)-beta, and platelet derived growth factor (PDGF) receptors. The efficacy of imatinib has also been reported in the treatment of patients with refractory idiopathic PAH through its effects on vascular remodeling. Based on the mechanism of action and preliminary patient data, we hypothesize that imatinib may be effective in the treatment of the fibrotic and vasculopathic features of patients with SSc. This is an open label pilot study to evaluate the safety and efficacy of imatinib in patients with progressive SSc refractory to other treatment(s). Validated measures of skin thickness and disease activity will be determined over 6-months of therapy and compared with baseline measures.


Eligibility Criteria:
Inclusion Criteria:

Adults with refractory diffuse or limited SSc and any or all of the following: Progressive cutaneous fibrosis, Interstitial lung disease, Pulmonary arterial hypertension, Digital ulcerations.

Exclusion Criteria:

Uncontrolled congestive heart failure, hypertension, or coronary artery disease.

HIV, hepatitis B, and/or hepatitis C infection. Serious infection within the past month. Significant hematologic, renal, or hepatic abnormalities. Concurrent use of intravenous immunoglobulin or cyclophosphamide within 4 weeks of the first treatment dose.

Concurrent use of a biologic agent (ie. etanercept, infliximab, adalimumab, abatacept) within 8 weeks of the first treatment dose (6 months for rituximab).

Women who are pregnant or breastfeeding.
Tramadol to Improve Its Detection in Biological Matrices in Anti-doping Controls

Orally single dose administration of Tramadol 75 mg for ultra-rapid metabolizers and 100 mg for extensive and poor metabolizers will be administered with the objective to evaluate urine and blood concentrations in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 55 years.
* Weight ≥ 50 kg and ≤ 100 kg.
* Body mass index (BMI) ≥ 18 and ≤ 30.
* Negative serum pregnancy test (women only).
* Signed informed consent prior to any study-mandated procedure.

Exclusion Criteria:

* Smoker of more than 5 cigarettes per day in the last 3 months prior to participate in the study.
* History of psychiatric disorders, alcoholism or drug abuse.
* Positive urine pregnancy test.
* No highly effective anticonception measures during the trial.
* Breastfeeding.
* Positive blood or urine test for drugs of abuse or alcohol breath test prior to study drug administration.
* Any clinically relevant disease or condition (cardiovascular, renal, hepatic, endocrine, hematology, neurology o other acute or chronic diseases) that in the judgment of the investigator might interfere with the subject's ability to comply with study procedures or requirements and/or bias the interpretation of the study results and/or jeopardize the subject's safety.
* Major Surgery last 6 months.
* Ongoing gastrointestinal diseases or history of gastrointestinal surgery affecting absorption.
* Subjects with a clinically significant disease within one month prior to study drug administration.
* Any clinically relevant findings in physical examination, vital signs, 12-lead ECG and safety laboratory parameters.
* Positive hepatitis or HIV test.
* Known hypersensitivity to any drug or drug excipients.
* Use of drugs known to induce or inhibit hepatic drug metabolism within one month prior to study administration or during the study and use of citrus juice during the study.
* Any prescription or over-the-counter (OTC) product including herbal, homeopathic, vitamins, minerals and nutritional supplements within 2 weeks prior to study drug administration.
* Intake of more than 5 units per day of beverages containing xanthine (coffee, tea or cola drinks).
* Donation of blood or plasma within one month prior to study drug administration or transfusion of blood or plasma for medical/surgical reasons or intention to donate blood or plasma within one month after study drug administration.
* History of inadequate venous access and/or experience of difficulty donating blood.
* Not able/not willing to accept restrictions regarding diet, physical exercise, and consumption of alcohol and/or xanthine containing items when out of CRU.
* Subject included in a clinical study within 3 months prior to study drug administration.
Effects of Commonly Used Medications on Mood and Choice

This non-treatment study will examine how commonly used prescription or over-the-counter medications may influence mood and medication preference.

Volunteers (aim is 36 completers) will participate in a double-blind study conducted over a period of about 14-17 weeks including sessions for screening, food and beverage diary review (Phase 1), drug exposure and choice sessions (Phase 2), and no-choice exposure sessions (Phase 3). During Phases 2 and 3, participants will orally ingest capsules containing varying doses of commonly prescribed over-the-counter medications and/or placebo. During screening, participants will be asked questions about participants' general characteristics including demographic information, mood, and personality. Participants will also be examined to determine medical eligibility. Eligible participants will proceed to Phase 1 in which participants will be asked to eliminate certain foods and beverages from participants diet, record participants daily food and beverage consumption and attend the laboratory approximately three times per week to discuss participants' food diaries. During Phases 2 and 3 food and beverage restrictions will remain in place and participants will report to the laboratory 2-5 times weekly in order to ingest study capsules and fill out questionnaires (e.g., about participants' current mood). After leaving the laboratory, participants will be asked to fill out surveys remotely in order to describe the effects of that session's capsules on mood and preference.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Fluent in written and spoken English and is capable of understanding and complying with the protocol
* Medically healthy
* Non-smoker
* Appropriate dietary/over-the-counter/prescription/illicit drug use history
* Body Mass Index between 18.5 and 35
* Appropriate use of birth control in females e.g., barrier methods, hormonal contraceptives, Intra Uterine Devices (IUDs)

Exclusion Criteria:

* Known hypersensitivity to administered drugs
* Current neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary or metabolic disease for which administration of the study drugs would be contraindicated
* Current psychiatric or substance use condition that would interfere with study participation
* Diastolic blood pressure \>90 mmHg or a systolic pressure of \>140 mmHg
* Use of medications that would interfere with study participation
* Past prescriptions that may affect study participation
* Unwilling or unable to comply with the protocol
* Any other serious disease or condition that might affect life expectancy or make it difficult to successfully manage the subjects according to the protocol
* Females: Pregnancy, breastfeeding, or plans to become pregnant
The Evaluation of a Novel Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea

This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F\&P trial nasal pillows mask amongst Obstructive Sleep Apnea (OSA) participants.

Visit 1 will involve the participants consented in to the trial. Participants will be fitted with the F\&P trial nasal pillows mask for use in-lab.

The participant will then return the mask and have a interview, this ensures the maximum time participants will be exposed to the trial mask in lab will be in 1 night.

The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all participants within 1 week of the beginning of the study.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18+ years of age)
* Able to give consent
* Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
* Prescribed PAP for OSA
* Existing nasal pillows mask user

Exclusion Criteria:

* Inability to give consent
* Patients who are in a coma or a decreased level of consciousness
* Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
* Commercial drivers who are investigated by New Zealand Transport Agency
* Current diagnosis of carbon dioxide (CO2) retention
* Pregnant or may think they are pregnant
Evoluation of Nurses' Skill Training on the Intramuscular Injection With Z Technique in Ventrogluteal Region

This research was planned as a randomized controlled experimental study in order to evaluate the effectiveness of the skill training given to nurses on intramuscular injection with the Z technique from the VG region.

Research Hypotheses H-0: The skill training given to nurses in applying intramuscular injection with the Z technique from the VG region does not affect the nurses' ability to inject with the Z technique from the VG region.

H-1: The skill training given to nurses on intramuscular injection with the Z technique from the VG region affects the nurses' ability to inject with the Z technique from the VG region.

This research was planned as a randomized controlled experimental study in order to evaluate the effectiveness of the skill training given to nurses on intramuscular injection with the Z technique from the VG region.

Eligibility Criteria:
Inclusion criteria:

• Nurses working in inpatient services other than emergency, outpatient clinic, operating room and pediatrics of a Health Practice and Research Hospital

Exclusion Criteria:

• Nurses who do not agree to participate in the research and/or want to leave the research while it is continuing
Reduction of Triglycerides in Women on Hormone Replacement Therapy

The purpose of this study is to test the effect of lifestyle intervention on subclinical cardiovascular disease measures in women taking hormone replacement therapy (HRT).

BACKGROUND:

Cardiovascular disease is a common cause of morbidity and mortality in older women. Better methods of prevention via health promotion are needed. Estrogen HRT may beneficially affect women's cardiovascular health, based on evidence from observational studies, but recent trial evidence suggests HRT may actually lead to increased risk of cardiovascular disease in new users. Understanding this untoward effect of HRT and how to prevent it is a significant aim.

DESIGN NARRATIVE:

This randomized trial of 500 women on HRT for at least two years, aged 52-60 years, and three or more years postmenopausal will test whether reduction in waist circumference, triglycerides, dense low density lipoprotein cholesterol (LDLc), number of LDL particles, C-reactive protein, and plasminogen activator inhibitor-I (PAI-I) by aggressive diet and exercise, versus a health education control, and will decrease progression or result in regression of measures of subclinical vascular disease. The intervention is designed to reduce total fat intake to 17 percent of calories, 1300 kilo calories, and increase moderate activity to 150-240 minutes per week to obtain a 10 percent reduction in weight. The primary endpoint will be a 20 percent or at least a 20 mg decrease in triglyceride levels, a 5 cm decrease in waist circumference, and a 10 percent decrease in LDLc. This will result in changes in subclinical measurements, including carotid ultrasound, electron beam computer tomography of the coronary artery and aorta, pulse wave velocity, endothelial function, and tonometry of the radial artery. Nuclear magnetic resonance spectroscopy of lipoproteins, inflammatory markers, and estrogen metabolites will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* On HRT for at least two years
* Women 52 to 60 years of age
* Three or more years postmenopausal
* Waist circumference greater than 80 cm
* LDLc between 100 and 160 mg/dl
* Body mass index 25-39.9 kg/m2
* Blood Pressure less than 160/95 mm Hg
* Beck Depression Inventory Score less than 20

Exclusion Criteria:

* Current use of cholesterol-lowering medication
* Diagnosis of diabetes
* On diabetes medication
Effect of Denosumab on Cellular Biomarkers in the Human Breast

To evaluate whether administration of denosumab results in a decrease compared to the control group in proliferation of mammary epithelial cells as measured by the Ki-67 proliferation index.


Eligibility Criteria:
INCLUSION CRITERIA:

* Willing to use, in combination with her partner, 2 non-hormonal methods of effective contraception or practice sexual abstinence. Subjects who are surgically sterile (eg, history of hysterectomy) or whose sexual partner is sterile (eg, history of vasectomy) are not required to use contraceptive measures
* Laboratory tests are within clinically acceptable range
* Clinically acceptable physical exam and no history or evidence of any clinically significant medical disorder that would pose a risk to subject safety or interfere with study evaluations or procedures.

EXCLUSION CRITERIA:

* Female subject with a prior history of breast cancer; breast implant in the breast to be biopsied; Known history of fibrocystic breast disease
* Subject is unable or unwilling to provide breast biopsy tissue from the upper outer quadrant of her breast
* Pregnant or plans to become pregnant while exposed to investigational product
* Lactating/breastfeeding or plans to breastfeed while exposed to investigational product
* Recent use of any non-approved medications or devices
* Uncontrolled thyroid disorder
* Significant dental/oral disease
* Planned invasive dental procedures
* Positive urine screen for alcohol and/or drugs
Open-label Study of CS-1008 for Subjects With Untreated and Unresectable Pancreatic Cancer

Phase 2 study to determine the efficacy and safety of CS-1008 when given with gemcitabine to subjects with previously untreated and unresectable (unable to be surgically removed) or metastatic (spread to other areas beyond the pancreas) pancreatic cancer.

Primary Objective:

- To evaluate the efficacy of CS-1008 administered in combination with gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic cancer, based on the progression-free survival at 16 weeks.

Secondary Objectives:

* To evaluate the efficacy of CS-1008 administered in combination with gemcitabine on overall progression-free survival rate, objective response rate, duration of response, and overall survival.
* To determine the pharmacokinetics of BIP CS-1008 and DSC CS-1008.
* To study potential biomarkers of CS-1008 activity
* To assess possible human anti-human antibody formation after exposure to CS-1008
* To evaluate the safety profile of CS-1008 when administered in combination with gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed resectable or metastatic pancreatic cancer; not previously treated with chemotherapy; measurable disease; 18 years of age or older

Exclusion Criteria:

* Anticipation of need for major surgery or radiation therapy during the study
* Heart Disease exclusions: myocardial infarction or unstable angina within the past 6 months; severe or unstable angina pectoris within the past 6 months; coronary or peripheral artery bypass graft within the past 6 mo., etc.
* Clinically significant active infection or history of HIV
* Partial or complete bowel obstruction
* Poorly controlled psychiatric illness
fMRI of Hypothalamic Responses to Glucose, Fructose, Sucrose and Sucralose

The study will consist of five occasions with one week in between. BOLD signal intensity of the hypothalamus will be measured using fMRI. Measurements will be done before and after drinking 300 ml plain water (reference) or water to which different sweeteners will be added.

The hypothalamus is known to be important for control of feeding behaviour as well as the regulation of temperature. Functional magnetic resonance imaging (fMRI) is a non-invasive method, which detects transient haemodynamic changes in the brain, using blood oxygen level dependent (BOLD) signal differences.

In order to investigate the role of hypothalamic neural activity in response to different sweeteners, fMRI will be performed before, during and after ingestion of 300 ml plain water or 300 ml water containing 50 g glucose, 50 g fructose, 50 g sucrose or 0.33 g sucralose (high intensity sweetener not providing energy). All beverages will be consumed at 22 °C.

The study uses a randomized cross-over design in 16 healthy male subjects with a normal body weight. There will be an interval of at least one week between the five occasions.

Blood Oxygen Level Dependent signal intensity of the hypothalamus will be continuously measured for 21 minutes (5 minutes baseline, 4 minutes during drinking and 12 minutes after drinking).

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age between 18 and 25 years
* BMI between 20 and 24 kg/m2
* Length between 170 and 190 centimetres

Exclusion Criteria:

* Diabetes or history of other disturbances of glucose metabolism (eg impaired glucose tolerance, hypoglycaemia).
* Any genetic or psychiatric disease (e.g. fragile X syndrome, major depression) affecting brain
* Any significant chronic disease
* Renal or hepatic disease
* Recent weight changes or attempts to lose weight (\> 3 kg weight gain or loss, within the last 3 months)
* Smoking (current or last 6 months)
* Alcohol consumption of more than 21 units per week or use of recreational drugs at present or in the last year
* Recent blood donation (within the last 2 months)
* Recent participation in other biomedical research projects (within the last 3 months), participation in 3 or more biomedical research projects in one year
* Contra-indication to MRI scanning:

  * Claustrophobia
  * Pacemakers and defibrillators
  * Nerve stimulators
  * Intracranial clips
  * Intraorbital or intraocular metallic fragments
  * Cochlear implants
  * Ferromagnetic implants
Evaluation of CTA on the Assessment of Brain Death

At present, different countries have different standards for the diagnosis of brain death, but according to the classic brain death confirmation test, it needs to be combined with transcranial Doppler, EEG, evoked potential and apnea test in clinical practice. Some patients cannot undergo a complete clinical examination and apnea test due to certain factors, and the determination of brain death is limited. The American Academy of Neurology (AAN) guidelines regard cerebral angiography as an acceptable auxiliary examination and is widely regarded as the gold standard for cerebral blood flow evaluation. CT cerebrovascular angiography (CTA) is a noninvasive and widely used examination method that can identify missing or severely reduced cerebral blood flow. However, due to limited experience and lack of sufficient evidence to prove its reliability, it is not included in the AAN A recognized auxiliary examination; there are also a large number of domestic and foreign literature reports that CTA can be used as a new confirmation test for clinical judgment of brain death.

This study aims to explore the value of CTA in the judgment of patients with brain death.


Eligibility Criteria:
Inclusion Criteria:

* Recruiting, no definite

Exclusion Criteria:

* Recruiting, no definite