cyrilzakka/clinical-trials huggingface dataset:
Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain

The main aim of the WESTCOR study is to

* investigate the ability of two high sensitive cardiac troponin (hs-cTn) assays to diagnose acute coronary syndrome and predict prognosis in different patient populations (e.g. gender, age and co-morbidity)
* to validate the suggested 1 hour protocol for rule in and rule out of acute coronary syndrome for two hs-cTn assays in an unselected chest pain population
* to investigate different biomarkers ability to predict long term prognosis after hospitalization for chest pain

The WESTCOR-study will include patients presenting to the Emergency Department of Haukeland University Hospital and Stavanger University Hospital with symptoms indicative of acute coronary syndrome. 1500 patients will be included at Haukeland University Hospital and 400 at Stavanger University Hospital. The two locations use different high sensitive troponin assays (i.e. hs-cTnT and hs-cTnI (Abbott Diagnostics) for routine diagnostic of coronary syndrome.

1900 patients will be sampled and hs-cTnT or hs-cTnI (as applicable) will be measured at admission, after one (2/3 of the cohort), three hours and after 8-12 hours. Clinicians will be blinded to the results of the hs-cTn assay that is not used as routine assay locally. Final diagnosis will be made by two independent cardiologists based on all available clinical information and results of the routine tests. The ability to diagnose or exclude MI ACS, and MACE at different sampling points in different patient populations will be compared for different biomarkers. 1500 patients will have a sample 1 hour after admission. The clinicians will be blinded to the results of this sample (both hs-cTn assays). The ability of the one-hour sample to diagnose or exclude myocardial infraction (MI), ACS and MACE will be compared between biomarkers.

All patients will be invited to take a follow-up sample 3 months after discharge.

The patients will further be followed for 1-5 years through national registers and the prognostic value of hs-cTn concentrations and dynamics as well as other biomarkers, will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the Emergency Department with a clinical suspicion of acute coronary syndrome i.e. chest pain or pain radiating down the arms, the back, into the jaw, throat or into the lower teeth. Chest pain must not be the most dominant symptom but may or may not be combined with e.g. dyspnea, nausea, anxiousness or palpitations.
* Age \>= 18 years

Exclusion Criteria:

* ST elevation MI
* Age \< 18 years
* Patients not able to give informed consent
* Patients suffering from terminal illness (life expectance \< 1 month)
* Patients already included in the study
* Patients who have been stabilized at local hospitals and are referred for second opinion e.g. coronary angiography
Combined Effects of Buteyko Breathing Technique and Chest Wall Mobilization on Pulmonary Functions and Quality of Life

The study aims to evaluate the effects of Buteyko breathing techniques with and without chest wall mobilization on pulmonary functions, and quality of life in chronic smokers. The study design will be a randomized clinical trial. The study will be completed in 10 months after the approval of the synopsis from the Ethical Committee of RCRS \& AHS. A non-probability convenient sampling technique will be used to recruit the individuals. Group 1-Buteyko breathing technique + Chest Wall Mobilization and Group 2-Buteyko Breathing Technique + Without Chest Wall Mobilization

This randomized clinical trial will evaluate the combined effect of the Buteyko breathing technique and chest wall mobilization on pulmonary functions and quality of life in chronic smokers. A sample size of 40 is calculated through a non-probability convenient sampling technique. Participants will be recruited into Group 1 and Group 2 by lottery method (without replacement). Group 1 will be engaged in the Buteyko breathing technique + Chest Wall Mobilization and Group 2 will undergo Buteyko Breathing Technique + Without Chest Wall Mobilization. Pre and post-outcome measures of pulmonary functions will be measured through a digital spirometer and quality of life will be assessed by the St George Quality of Life Questionnaire.

Spirometry assesses the amount and speed of air that can be inhaled and exhaled. Key measurements include Forced Vital Capacity (FVC): The maximum volume of air forcefully exhaled after a full inhalation. Forced Expiratory Volume in 1 Second (FEV1): The volume of air exhaled in the first second of the FVC test, indicates how quickly the lungs can be emptied.

St Saint Georg quality of life questionnaire for assessing the QOL. The SGRQ is a standardized self-administered airway disease-specific questionnaire divided into 2 subscales, a total of 12 questions. For each subscale and the overall questionnaire, scores range from zero (no impairment) to 100 (maximum impairment).

Eligibility Criteria:
Inclusion Criteria:

* Both male and female participants were included
* The age of participants was 40 -55 years.
* Individuals who fulfilled the criteria of smoking which is calculated by multiplying the number of packs smoked per day by the number of years smoked were included.
* Individuals who are current smokers or history of long-term smoking were included.
* Predicted values FEV1 \< 75% and FEV1/FVC \<70%

Exclusion Criteria:

* Participants with neurological disorders were excluded
* Participants with musculoskeletal disorders were excluded as it affects the physical activity of the 6-minute walk test.
* Participants having any pulmonary complications or lung disease were excluded.
* Participants previously involved in any other exercise or physical activity were excluded.
A Safety, Tolerability, PD and PK Study in Healthy Adults

The primary objective of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of TRV734 given as a single dose (Part A) and as multiple ascending doses (Part B) in healthy subjects.

This will be conducted in two-parts enrolling a total of approximately 72 healthy volunteers.

* Part A will assess the safety, tolerability, PD and PK of a 125mg dose of TRV734 in an open-label, randomized, three-period crossover study in which subjects are fasted, fed a standard meal, or fed a high-fat meal.
* Part B of the trial will assess the safety, tolerability, PD and PK of multiple ascending doses of TRV734 in a double blind, double dummy, randomized, active- and placebo-controlled, adaptive study. Oxycodone immediate release (IR) 10 mg will be used as a benchmark.

Eligibility Criteria:
Inclusion Criteria:

* Healthy as determined by a responsible physician or trained qualified designee
* Males (Part A) or males and females (Part B) between 18 \& 64 years of age, inclusive. Females must be of non-childbearing
* Capable of giving written informed consent

Exclusion Criteria:

* Clinically significant conditions, or history of fainting or syncope
* Medical or psychiatric illness
* Major surgery within 4 weeks of screening
* Known difficulty with obtaining intravenous access
* Any ophthalmologic condition that could interfere with pupillometry
* History of sensitivity to any of the investigational products, or known intolerance to opioids or a history of medication or other allergy
* Use of prescription or non prescription medications
* History of drug abuse within 6 months of screening
* Use of any illegal drug within 30 days of screening and throughout participation in the study
* History of smoking or use of nicotine containing products within 3 months of screening and throughout participation in the study
* Donation of blood or plasma within 4 weeks prior to dosing
* Participation in a clinical trial and has received a medication within 30 days
* Weight \<50 kg or BMI outside range of 18 - 32 kg/m2
* Positive for HIV antibody, hepatitis B virus surface antigen, or hepatitis C virus
* If male, unwillingness to abstain from sexual intercourse with a pregnant or lactating woman and, if engaging in sexual intercourse with a female partner of childbearing potential, use a condom and spermicide, in addition to having their female partner use another form of contraception, and abstain from sperm donation
* Part B Only:

  * Active dermatological condition or eczema on non-dominant hand.
  * Peripheral vascular disease
  * If female, of child bearing potential, pregnant or breastfeeding
The Effect of Exercise Intervention on the Community's Older Adults

Osteoporosis is a serious global health problem, second only to cardiovascular disease. Osteoporosis is the most common metabolic bone disease in the elderly population, characterized by loss of bone mineral density (BMD) and continuous destruction of bone microstructure, especially in postmenopausal women. It gives rise to bone fragility and fracture risk. Moreover, as people grow older, falls frequently occur with high severity, and nearly 35% to 45% of persons aged 65 or older fall at least once a year. Osteoporotic fractures increase mortality, morbidity, chronic pain, and the cost of social care and it decreases the quality of life. Here, investigators plan to perform different exercise interventions such as circuit exercise, aerobic dance and Tai Chi on the community's older adults to evaluate whether exercise intervention could improve the bone mineral density, physical fitness, muscle strength or quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Being \>45 years-of-age,
* Healthy and physically independent.

Exclusion Criteria:

* The exclusion criteria were individuals on hormone replacement therapy and those with cognitive impairment, progressive debilitating conditions, bone fractures, or any medical contraindications to administering the fitness assessment.
Zinc Sulfate for Human Papillomavirus (HPV)

The Human Papillomavirus (HPV) is well established as the primary causative agent in both warts and cervical cancer. Although cervical high risk HPV (hrHPV) infections have a high rate of spontaneous resolution this takes time and the infection can cause cervical cells to progress to precancerous and cancerous lesions. Zinc has been shown to play a central role in immunity. This study is to determine if oral zinc sulfate can improve clearance rates of high risk HPV versus placebo.

Upon enrollment eligible participants will be randomized and given a three-month supply of zinc sulfate or placebo to be taken as directed. They will have zinc serum lab testing at enrollment and upon study completion. Patients will also be asked to complete short questionnaires and to make study staff aware of any side effects they should experience.

Eligibility Criteria:
Inclusion Criteria:

* Abnormal cytology of atypical squamous cells of undetermined significance (ASCUS) on Pap smear OR
* Low-grade squamous intra epithelial lesions (LSIL) on Pap smear OR
* Positive hrHPV on routine screening (positive HPV will be assumed to be high grade)

Exclusion Criteria:

* Patients who proceed to excisional procedures (loop electrosurgical excision procedure or cold knife conization)
* Pregnant patients
* Breastfeeding patients
* Immunocompromised patients
Prophylactic Negative Wound Therapy in Laparotomy Wounds.

Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. The impact of different types of wound therapy are not clear in the literature.

The hypothesis of this study is that NPWT has the potential to reduce Surgical Site Infections, however no study has compared the most commonly used products against standard dressings.

In the era of enhanced recovery, improving modifiable peri-operative and post-operative factors is essential to better patient outcomes. Surgical site complications in the form of wound infections are a major burden to the healthcare system. Negative pressure wound therapy (NPWT) as delivered by a surgical incision management system (SIMS) is a novel approach to improve wound healing when applied to closed incisions.

However, data is limited in its application to laparotomy incisions in the acute and elective care surgery setting. Surgical site infections can complicate a patient's post-operative course significantly, often necessitating a longer length of stay, antibiotic therapy, intervention for wound collections and impair patient mobility and overall recovery.

In addition to this, laparotomy wound complications can possibly delay adjuvant therapy and also increases healthcare costs both as an inpatient and in the community. Despite significant measures to reduce such complications in the form of wound care bundles, changing of gloves prior to wound closure etc, surgical site complications continue to represent a huge healthcare burden.

Aim;

1. To determine if prophylactic negative pressure wound therapy confers a lower rate of Superficial Site Infection or reduces wound complications in Emergency or Elective Laparotomy wounds thereby improving post-operative patient recovery and reducing healthcare costs.

Eligibility Criteria:
Inclusion Criteria:

* All patients over the age of 18 years of age undergoing a laparotomy are eligible for entry into this study. Benign and malignant conditions are eligible for inclusion.

Exclusion Criteria:

* Pregnant patients and those undergoing re-look laparotomies are to be excluded.
Hydration to Optimize Metabolism

This study evaluates hydration (1.5 L of water daily during 1 year) in the lowering of blood glucose concentration in adults with signs of dehydration (elevated levels of the vasopressin marker copeptin and high urine osmolality). Half of participants will in addition to lifestyle advice receive extra water on top of their habitual fluid intake, and the other half (control) will receive only lifestyle advice.

High plasma concentration of vasopressin (i.e. antidiuretic hormone) is a novel and independent risk factor for type 2 diabetes, the metabolic syndrome, cardiovascular disease and premature death. The main physiological role of vasopressin is to maintain constant plasma osmolality. Previous studies in rats and mendelian randomization studies in humans suggest causality between elevated vasopressin concentration and elevated plasma glucose concentration. As vasopressin can be suppressed by increasing water intake, we hypothesize that water supplementation in individuals with high vasopressin can lower plasma glucose and prevent diabetes.

The aim of this project is to test in a single-centre randomized clinical trial (RCT), if water supplementation in subjects with high plasma levels of vasopressin (measured by a stable vasopressin marker of its precursor hormone called copeptin) can reduce fasting levels of glucose (primary outcome measure), risk of new-onset diabetes and other cardiometabolic risk factors (secondary outcome measures).

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent, age 20-75 years with high plasma concentration of vasopressin (plasma concentration of copeptin of \> 6.1 pmol/L in women and \> 10.7 pmol/L in men) and 24 hour urine osmolality \> 600 milliosmol (mOsm) /kg water.

Exclusion Criteria:

* 24 hour urine volume \> 1.5 L, pregnancy or breastfeeding, plasma sodium \< 135 mmol/L, use of diuretics, lithium or selective serotonin reuptake inhibitor (SSRI) drugs, chronic kidney disease (estimated glomerular filtration rate \< 30 mL/min), heart failure, inflammatory bowel disease, type 1 diabetes or type 2 diabetes treated with insulin, vulnerable subjects (subjects with legal guardian, with loss of personal liberty).
Exploratory Trial of a Group Psychological Intervention for Postnatal Depression in British Mother's of South Asian Origin

This study is an exploratory randomized controlled trial (RCT) of a group psychological intervention for postnatal depression in British mother's of south Asian origin. The aim is to evaluate the efficacy of a group psychological intervention (PHP) based on the principles of Cognitive Behaviour Therapy in treating depression in postpartum women. The hypothesis is that depressed British women of South Asian origin receiving the group intervention will show significant improvements in terms of severity of depression as compared to the treatment as usual (TAU) control group.


Eligibility Criteria:
Inclusion Criteria:

* self-ascribed British women of South Asian origin as defined by UK Office of -National Statistics,
* over the age of 16 years
* living with their babies,
* who meet the criteria for ICD-10 depression

Exclusion Criteria:

* women with diagnosed physical or learning disability,
* post-partum or other psychosis,
* severely depressed
* actively suicidal.
Neuronavigation Guided iTBS With Personalized Target for Depression

The study will compare the efficacy of intermittent Theta Burst Stimulation (iTBS) with DLPFC-pgACC personalized target for major depressive disorder (MDD) and explore possible brain network mechanisms. The stimulated targets will be located by magnetic resonance imaging (MRI) based on functional MRI based on functional connectivity respectively. This study aims to identify that functional connectivity targeted iTBS protocols on DLPFC-pgACC personalized target have a better antidepressant efficacy compared the sham group and certify that pgACC is an effective potential effector target.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 60 years old
* Meet the criteria of the Diagnostic and Statistical Manual of Mental Disorder- V of MDD, single or recurrent
* Meet the threshold on the total HAMD17 score of \>17 at both screening and baseline visits
* Able to provide informed consent

Exclusion Criteria:

* any other current or past psychiatric axis-I or axis-II disorders
* severe physical illnesses
* psychotic symptoms, alcohol or drug abuse
* A history of neurological disorders including seizure, cerebral trauma
* MRI evidence of structural brain abnormalities
* Contraindications to MRI and rTMS
* Acute suicide
* Female that is pregnant or breastfeeding
A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia

The purpose of this study is to evaluate sleep onset following administration of Transcept zolpidem tartrate sublingual tablet versus placebo in adult insomnia patients.


Eligibility Criteria:
Inclusion Criteria:

* Insomnia as defined by DSM-IV criteria and supported by subject diary
* Male or female between the ages of 18-64 years
* Body mass index (BMI) between 18-34 kg/m\^2
* Females of childbearing potential must use a medically acceptable method of contraception
* Capable of understanding and willing to comply with study procedures and has provided informed consent

Exclusion Criteria:

* Females who are pregnant, breast-feeding or have a positive pregnancy test
* Any circadian rhythm disorder including planned travel across several time zones during the study period
* Known hypersensitivity to Zolpidem
* Has performed regular shift work with the past several months prior to screening
* An acute clinically significant illness or surgery as determined by the PI within 30 days of screening
* Patients that have used any central nervous system (CNS) medication or other medication known to impact the sleep/wake cycle
* A history of psychiatric disorder as defined by DSM-IV
* A history of drug addiction or alcohol abuse
* Any current significant disease, unless adequately controlled with a protocol allowed medication
* Known history of HIV or Hepatitis B or C
* Patients who have received an investigational drug within several months of screening
To Evaluate the PK, PD, Safety and Drug Tolerance in Healthy Volunteers

1. To evaluate the pharmacokinetic and pharmacodynamics characteristics after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions
2. To evaluate the safety and drug tolerance after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions

1. It is analyzed for subjects who receive scheduled clinical trial drugs according to the clinical trial plan, have no significant violations in comparative analysis, and have completed all scheduled blood collection for pharmacokinetic evaluation.

   To analyze subjects who receive clinical trial medications scheduled according to the clinical trial plan, have no significant violations in comparative analysis, and have assessable intragastric pH information by completing a 24-h pH monitoring measurement.
2. All subjects who received more than one dose of clinical trial drugs are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Subjects does not meet the Inclusion Criteria
Decoding Presymptomatic White Matter Changes in Huntington Disease

WIN-HD is a monocentric longitudinal study comparing premanifest Huntingtin (HTT) mutation carriers and non HTT mutation carriers to determine that white-matter atrophy occurs far earlier than clinical onset in HD using Diffusion-weighted Nuclear Magnetic Resonance (N spectroscopy (DWS) and Diffusion Tensor Imaging (DTI).

The investigators will recruit up to 20 premanifest HTT mutation carriers (15 completed) and up to 20 non HTT mutation carriers (15 completed). It is important to have those 2 populations in order to compare our results and determine if there are significant white-matter changes far from the onset of HD. Therefore, non HTT mutation carriers will be age and gender matched to premanifest HTT mutation carriers.

In order to test the hypothesis, the study has 2 visits with a year interval.

This study is based on 4 principal criteria:

1. Imaging criteria
2. Clinical and neurological criteria
3. Psychological criteria
4. Behavioral criteria


Eligibility Criteria:
Inclusion Criteria:

* For presymptomatic individuals:

  * Genetic test available with CAG (Cytosine-Adenine-Guanine) repeat length \> 36 in HTT gene
  * UHDRS score \<5
  * Burden score \<250
* For controls:

  - Genetic test available with CAG repeat length ≤ 36 in HTT gene
* Common inclusion criteria for presymptomatic individuals and controls (age-matched and gender-matched with presymptomatic individuals and but without any familial relationship):

  * At least 18 years of age
  * Capacity to consent
  * Signature of the informed consent
  * Covered by social security
  * Ability to undergo MRI scanning

Non-Inclusion Criteria:

* Under the age of 18 years of age
* Contra-indications to MRI examination (metallic implant, pacemaker, artificial heart valve, brain vascular malformation, aneurysm clips, exposed by metallic fragments, artificial implants, peripheral or neuronal stimulator, insulin pump, intravenous catheter, epilepsy, person with an history of seizure, metallic contraceptive device, permanent eyelid make up, claustrophobia,...)
* Unwillingness to be informed in case of abnormal MRI (with a significant medical anomaly)
* History of severe head injury
* History of neurological disorder or presence of neurological disorder
* Participation in a drug trial or exclusion period of another study
* Pregnancy or breastfeeding
* Inability to understand information about the protocol
* Person deprived of their liberty by judicial or administrative decision
* Person under legal protection (legal guardianship, tutelage or maintenance of justice)
* Person without any protection and unable to consent