cyrilzakka/clinical-trials huggingface dataset:
Pathophysiological Explorations of Red Blood Cells

GR-Ex is a program labelled by Labex (Laboratory of Excellence) by the French Ministry of Higher Education and Research. This program aims to develop the means to improve knowledge in the physiology and pathologies of erythropoiesis, red blood cells and iron metabolism, and to develop new therapeutic protocols capable of providing added value in terms of innovation.


Eligibility Criteria:
Inclusion Criteria:

* To be affected or have a family history of disease bound to the red blood cell,
* For adult subjects, have signed an informed consent form,
* For minor or major under legal safeguard subjects, the form must be signed by both parents (for minors) or by the legal representative,
* Be affiliated to health insurance.

Exclusion Criteria:

* Being deprived of freedom
Electronic Warning System for Atrial Fibrillation

The aim of this randomized controlled study is to evaluate whether a newly designed electronic warning system will increase the initiation rate of adequate stroke preventive measures in patients with atrial fibrillation.

A large proportion of patients with atrial fibrillation do not receive stroke prevention therapy in line with the guidelines, in spite of the presence of an increased risk of stroke. It will be investigated whether an electronic alert to physicians, whose patients with atrial fibrillation do not receive stroke preventive measures, will increase the rate of adequate stroke preventive measures as compared to a control group of patients without an electronic alert. The electronic alerts will be sent if patients with atrial fibrillation but without adequate stroke preventive measures receive in-patient treatment at the University Hospital Bern. The electronic alert system includes a feature that helps the physicians in charge to evaluate the CHA2DS2VASC Score. At the end of the hospital stay medical discharge letters will be reviewed for initiation of adequate stroke preventive measures.

Eligibility Criteria:
Inclusion Criteria:

* All in-patients with atrial fibrillation

Exclusion Criteria:

* Ongoing anticoagulant therapy
The Effect of Kiwi on Blood Pressure, Endothelial Function, Antioxidant Capacity and Gene Expression

The purpose of this study is to determine whether the intake of kiwi fruits will reduce systolic and diastolic blood pressure compared to intake of apples. The investigators hypothesize that the increased intake lutein or other components in the kiwi fruit will enhance nitric oxide bioavailability and lead to vascular relaxation.

An interesting finding in the Oslo Antioxidant Study was that intake of 3 kiwi fruits reduced blood pressure in a clinical significant manner compared to controls. The mechanism for the blood pressure reducing effect of kiwi or the responsible components are not elucidated. However, plasma lutein levels and antioxidant capacity measured by the ferric reducing antioxidant power was increased in the kiwi group. Moreover, gene expression was also altered by the increased intake of kiwi.

Eligibility Criteria:
Inclusion Criteria:

* Systolic blood pressure 130-159 mmHg
* Diastolic blood pressure 85-99 mmHg
* Body mass index \<35 kg/m2

Exclusion Criteria:

* Systolic blood pressure \>160 mmHg or \<129 mmHg
* Diastolic blood pressure \>100 mmHg or \<84 mmHg
* Current use or need for blood pressure lowering medication
* Symptomatic cardiovascular disease, diabetes, renal dysfunction, psychiatric disorder, pregnancy or lactation, history of obesity surgery.
GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection

This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human immunodeficiency virus type 1 (HIV-1) infection who have received no prior HIV treatment. Patients will be randomized to receive either saquinavir/ritonavir 1000/100mg oral (po) twice daily (bid) + emtricitabine/tenofovir 200/300mg po once daily (qd), or lopinavir/ritonavir 400/100mg po bid + emtricitabine/tenofovir 200/300mg po qd. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic HIV-1 infection;
* treatment-naive;
* HIV-1 RNA viral load \>=10,000copies/mL;
* women of childbearing potential must have a negative pregnancy test, and must use reliable contraception for the duration of the study and for 90 days after the last dose of study medication.

Exclusion Criteria:

* females who are pregnant or breastfeeding;
* active hepatitis B infection;
* previous treatment with antiretroviral medication;
* patients who have received an investigational drug within the last 4 weeks.
Association of PICP Serum Marker in Patients With LVSD

The purpose of this study is to determine if the carboxy-terminal of procollagen type I (PICP) can be a useful marker of different degrees of myocardial fibrosis.

Abnormality of diastolic function, particularly a more advanced form known as restrictive tilling pattern, has been correlated with worse outcome in patients with systolic dysfunction associated with chronic heart failure or following an acute myocardial infarction. Recently, the severity of diastolic dysfunction has also been shown to predict the response to cardiac synchronization therapy for refractory heart failure due to systolic dysfunction.

Varying degree of diastolic dysfunction has been reported among patients with comparable severity of systolic dysfunction. The underlying mechanisms responsible for the observed discordance between systolic and diastolic dysfunction in these patients remains incompletely understood.

The carboxy-terminal of procollagen type I (PICP), a peptide that is cleaved from procollagen type I during the synthesis of fibril-forming collagen type I, has been associated with myocardial fibrosis. Myocardial fibrosis is a major determinant of both systolic and diastolic function of the heart. We hypothesize that differential degrees of myocardial fibrosis may be responsible for these discrepancies.

Eligibility Criteria:
Inclusion Criteria:

1. Evidence of left ventricular systolic dysfunction (measured LVEF% less than 35%) measured by echocardiography within the previous three months at the time of enrollment
2. Greater than or equal to 18 years of age
3. Greater than or equal to 110 pounds in weight

Exclusion Criteria:

1.Non-sinus rhythm at the time of enrollment
Diet and Well-being of Young Danish Children Born by Obese Mothers

The overall aim is to provide a detailed description of growth, development and risk factors for later disease, especially obesity and metabolic disease in infants born by obese mothers and to compare them with a group of infants born by mothers without any restriction in prepregnancy BMI (SKOT I).

The SKOT II is a prospective cohort study that includes children of obese mothers with a body mass index over 30 kg/m2. These mothers were invited to SKOT II while participating in a randomised study at Hvidovre Hospital, Copenhagen. The families were invited to three examinations, when the children were 9, 18 and 36 months of age. A total of 184 children were included in 2010. The examinations and the collecting of data are designed in the same way as SKOT I, a study of healthy children born by non-obese mother. The examinations takes place at Department of Nutrition, Exercise and Sports, Frederiksberg, Denmark. Following data were collected during the examinations: Anthropometry (weight, height, age- and sex specific Z scores for body composition, triceps- and subscapularis skinfolds), background interview (e.g. infant feeding, household income, the parent's educational level, allergy and chronic diseases), blood pressure (systolic, diastolic and mean arterial pressure), faeces- and urine samples, blood samples (at 9 and 36 months of age), bio impedance (at 36 months of age), 4 day diet registration, general questionnaire (e.g. sleep, daycare, attendance and use of screen devices), psychomotor questionnaire (motoric development) and 7 day physical activity monitoring (at 36 months of age).

Eligibility Criteria:
Inclusion Criteria:

* Healthy singletons born at term (week 37-43) with no disease that could influence food intake or growth. Born by obese mother (BMI ≥ 30 kg/m2) Mothers participated in a intervention study at Hvidovre Hospital

Exclusion Criteria:

* Born preterm (before week 37) Non-Danish speaking parents. Chronic disease that is expected to influence growth or food intake.
Combined Treatment for Generalized Anxiety Disorder (GAD)

The purpose of this study is to conduct a preliminary evaluation of the efficacy of combined medication and psychotherapy for generalized anxiety disorder (GAD). The general goals of the current study are to conduct a late stage treatment development study. The goal of this stage of research is to provide a preliminary answer to the question and to gather data to estimate intervention parameters (e.g., effect size, attrition rates, response rates) that would assist in planning further research.

The specific aims of this study are to collect preliminary data relevant to the following hypotheses:

1. Primary Hypothesis: Acute phase improvement for combined cognitive behavioral therapy (CBT) plus medication will be superior to medication alone.
2. Secondary Hypotheses: Combined CBT plus medication will be superior to medication alone on a number of secondary outcome measures, including the core feature of GAD (worry), depressive symptoms, functional impairment, and quality of life.
3. Additional Exploratory Aim: We will explore the comparative relapse rates for the combined CBT plus medication treatment and the medication alone treatment condition at 6-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* GAD diagnosis by structured interview
* Hamilton Anxiety Scale score of 18 or less
* Clinical Global Impressions Scale score of at least 4
* Hamilton Depression Scale score of 18 or less
* Hamilton Depression Scale suicide item score less than 2
* Use of an effective form of contraception throughout the s

Exclusion Criteria:

* Hypersensitivity to venlafaxine XR
* History of seizures
* Episode of major depressive disorder in the previous 6 months
* History of any psychotic illness, bipolar disorder, or dementia
* Substance abuse and dependence during the past 6 months
* Other anxiety disorders with the exception of social phobia as long as GAD is primary
* Regular use of anxiolytics or antidepressants within 7 days of study onset
* Use of fluoxetine or monoamine oxidase inhibitors within 28 days of study onset (low dose usage of benzodiazepines will not prevent participation)
* Use of other psychotic medication besides benzodiazepines
Methylselenocysteine Effects on Circadian Rhythm

The primary objective of this study is to determine if vitamin supplementation with a naturally occurring dietary amino acid called organic selenium (i.e., methylselenocysteine) can restore disruption of circadian rhythm in shift workers.

All living cells have a circadian (daily) rhythm which controls a variety of bodily functions that change throughout the day, including body temperature, sleep, hunger, activity, hormone levels, etc. The circadian rhythm of the body is controlled by the amount of light that enters our eyes, so on our planet the length of the rhythm is 24 hours long. It is therefore reasonable to suspect that upsetting the timing of the rhythm would lead to changes in body function (as commonly experienced in "jet lag") and that prolonged changes might even lead to alterations in bodily functions and contribute to disease. This suggests that people whose service to the community that requires that they often work at night (nurses, doctors, police, hospital staff, firefighters, airline crews, factory workers, etc), might be at elevated risk of developing diseases. Studies have shown that women who do shift work have an elevated risk of breast cancer, probably as a result of altered hormone levels and cycling. Other studies have shown that vitamin supplementation with a naturally occurring dietary amino acid called organic selenium (i.e., methylselenocysteine) can restore this disrupted rhythm and possibly decrease this disease risk. Thus, the purpose of this study is to investigate whether taking daily selenium (i.e., methylselenocysteine) will restore the disrupted circadian rhythm in shift workers.

Eligibility Criteria:
Inclusion Criteria:

* Permanent night shift schedule

Exclusion Criteria:

* Nutritional supplements that contain selenium
* Pregnant
* Breast feeding
* Heart conditions
* Chronic lung disease
* Cancer therapy (current or past)
Community Health Worker Intervention to Improve Post-Hospital Outcomes

This study tests an intervention designed to avoid 30-day readmissions following a medical hospitalization by patients who have co-occurring mental illness. The Intervention is delivered by community health workers in the inpatient setting and 30 days following hospital discharge to the community.

This study will test the efficacy of a brief intervention delivered to adults with co-occurring medical and mental health conditions by community health workers designed to avoid 30-day readmissions following medical hospitalization. Adult inpatients of a university hospital will be randomly assigned to the intervention plus services as usual versus services as usual alone, and assessed at baseline and 30 days following discharge. Chi square will be used to assess the primary outcome of admission within 30 days of discharge and changes in patient activation, mental health symptoms, medication adherence, and perceived competence for health maintenance. Also examined will be study condition differences in post-discharge inpatient service utilization and cost.

Eligibility Criteria:
Inclusion Criteria:

* receiving inpatient treatment for chronic medical condition
* evidence of a mental health diagnosis
* age 21- 60 years
* expected to return to community residence
* residing within a 30-mile radius of the hospital
* expected to remain in hospital for 2 or more days
* able to provide informed consent

Exclusion Criteria:

* terminally ill
* unable to communicate in English
* expected to be discharged to skilled facility or nursing home
* participating in another transitional care intervention
* hospitalized for behavioral health disorder
Observational Study Investigating the Effectiveness of Fentanyl Matrix in Relieving Pain and Improving Function in Patients With Osteoarthritis of the Knee or Hip

The purpose of this study is to investigate the utility of fentanyl matrix for the treatment of pain due to osteoarthritis (OA) of knee or hip, which was not adequately controlled by non-opioid analgesic (e.g. NSAIDs or COX-II inhibitors) or weak opioids \[tramadol HClacetaminophen, tramadol or codeine (or combinations with acetaminophen/ibuprofen)\].

This study is a prospective, open-label, non-interventional study. The objective of this study is to investigate the utility of fentanyl matrix after 8 week treatment of fentanyl matrix for the treatment of pain due to osteoarthritis (OA) of knee or hip, which was not adequately controlled by non-opioid analgesic (e.g. NSAIDs or COX-II selective inhibitors) or weak opioids \[tramadol HCl with acetaminophen, tramadol or codeine (or combination with acetaminophen/ibuprofen)\] in clinical practice according to the investigator's discretion. This study will investigate the usefulness of fentanyl matrix based on improvement in pain and function after Fentanyl matrix administration in patients who complained of pain caused by osteoarthritis and indicated for Fentanyl matrix administration in clinical practice at the investigator's discretion. This study will also measure the patients' functional improvement through Korean Version of WOMAC. Observational study - No investigational drug administered

Eligibility Criteria:
Inclusion Criteria:

* Patients who complain of chronic pain caused by osteoarthritis of the knee or hip persisting for 3 months or longer
* Patients who can fully observe the overall clinical study requirements including K-WOMAC completion at the investigator's discretion
* Patients who complain of severe pain (NRS score = 7) because pain was not treated enough with the previous analgesic
* Patients who have never been administered strong opioid analgesics over the last one month

Exclusion Criteria:

* Patients with a history of the drug or alcohol abuse in the past or now
* Childbearing women who are pregnant or likely to be pregnant during the study period and male subjects who are neither infertile nor willing to refrain from sexual relations but whose partner does not conduct an effective contraception (implant, injections, oral contraceptives, intrauterine device, etc.)
* Patients who are unable to use a transdermal system due to skin disease
* Patients with serious mental disorder
* Patients with history of hypersensitivity to opioid analgesics
* Patients with history of CO2 retention
* Patients who are not eligible for the study participation based on warnings, precautions and contra medications in the package insert of the study drug at the investigator's discretion
Restore Claims Characterization Study

The purpose of this study is to characterize the pain coverage capability of the RESTORE spinal cord stimulation (SCS) and assess health outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Has chronic refractory pain associated with one of the conditions currently approved for spinal cord stimulation as follows: Failed Back Syndrome, Degenerative Disk Disease (DDD), Herniated Disk pain refractory to conservative and surgical interventions, Peripheral Causalgia, Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD).
* Primary pain in the lower half of the body.

Exclusion Criteria:

* Requires, or will in the future, diathermy treatments.
* Had implanted spinal cord stimulation system within the last six months.
Myocardial Infarction in the Elderly

An observational registry study of patients aged 75 years and older with an established diagnosis of myocardial infarction, initiated in 2020, with an assessment of clinical, instrumental, demographic and prognostic data. Statistical analysis was performed using the StatTech v. 4.5.0 program (developer - StatTech LLC, Russia). Differences were considered statistically significant at p \<0.05.


Eligibility Criteria:
Inclusion Criteria:

- age 75 years and older, presence of an established diagnosis of myocardial infarction at the time of hospitalization.

Exclusion Criteria:

-
IMPACT2: Monitoring Interventions to Improve Artemisinin-based Combination Therapy (ACT) Access and Targeting

It is generally agreed that artemisinin-based combination therapy (ACT) is the malaria therapy of choice but there is much less agreement about the best ACT-deployment strategies. Countries are now beginning to adopt policies to enhance ACT deployment that aim to address 2 key goals: (i) making ACTs more readily and speedily accessible to patients: or (ii) targeting ACTs to patients shown to have malaria parasitaemia.

The Tanzanian Government has secured funding to address both ACT access and targeting on a national scale. Access is to be improved through the distribution of subsidised ACTs through private facilities and retail drug shops under the Affordable Medicines Facility-malaria (AMFm). Targeting is to be addressed through enhancing microscopy and introducing rapid diagnostic tests (RDTs) in health facilities at every level of the system.

This study will evaluate these two interventions in 3 rural regions of Tanzania which are all expected to receive both interventions during the study period. The investigators will assess the effectiveness of the interventions in terms of coverage, equity, quality, adherence, and public health impact using a pre-post plausibility design based on before and after household, health facility and outlet surveys. The null hypothesis is that the interventions will have no impact on the coverage of prompt effective treatment for fever and malarial. In addition, the investigators will estimate the cost and cost-effectiveness of implementation from a health system and household perspective. Finally the investigators will explore the socio-cultural context and other factors that influence the implementation and outcome of the interventions.


Eligibility Criteria:
Inclusion Criteria:

* Household survey - All consenting and assenting residents available in selected households
* Health facility survey - patients presenting to selected health facilities with fever or history of fever in the prior 24 hours; Age \>= 3 months, or Weight ≥ 5 kg; First visit to this health facility for this illness episode

Exclusion Criteria:

* Household survey - Children less than 3 months of age will be excluded from providing a blood sample
* Health facility survey - Signs of severe illness
Determinants of Corticosteroid Insensitivity in Smokers With Asthma

Smokers with asthma display a relative insensitivity to inhaled and oral corticosteroids. The causes of this phenomenon are currently unknown. The investigators will perform a number of blood \& breathing tests to try to discover the cause/s behind this phenomenon with the aim of producing leads for further investigation and possible new treatments for smokers with asthma.

Smokers with asthma display a relative insensitivity to inhaled and oral corticosteroids. The causes of this phenomenon are currently unknown. However research into steroid resistance in severe asthma and the smoking related condition chronic obstructive pulmonary disease (COPD) points to a number of possible causes. We will characterise a group of smokers with asthma and perform a number of investigations and compare the results to ex-smokers and never smokers with asthma with the aim of establishing which previously published steroid resistance phenomena are related to the steroid resistance displayed by smokers with asthma. Results produced from this trial will provide hypothesis generating information leading to future pharmaceutical trials.

Eligibility Criteria:
Inclusion Criteria:

* Asthma (defined by either reversibility to bronchodilator or methacholine testing)
* Asthma duration of 6 months or greater
* Stable asthma
* Age 18-60
* Treatment with inhaled corticosteroids
* Smoking history consistent with group

  * smokers with asthma: \> or = 5 pack years and currently smoking more than 5 cigarettes per day
  * ex-smokers: smoking ceased \> or = two years prior to recruitment, minimum 5 pack year history
  * non-smokers: no smoking history

Exclusion Criteria:

* Presence of medical condition likely to be exacerbated by treatment with oral corticosteroids
* Treatment with \> 2000 mcg beclomethasone (or equivalent) per day
* Subject requires oral corticosteroids to maintain asthma control
* Subject requires oral theophylline to maintain asthma control
* Recent treatment with oral corticosteroids
* Pregnancy or subject planning to become pregnant