cyrilzakka/clinical-trials huggingface dataset:
Effects of a Short-term Aerobic Interval Exercise Program on Cardiac Fat and Function in Women With Obesity: A Pilot Study

The overall goal of this project is to the study the effects of an aerobic interval training program on cardiac fat, and its relationship to cardiac function using cardiac Magnetic Resonance Imaging.


Eligibility Criteria:
Inclusion Criteria:

* females, age 18-40 years old, body mass index (BMI) ≥ 30 kg/m2 and \< 39.9 kg/m2, without known metabolic and/or cardiovascular disease

Exclusion Criteria:

* known CV, metabolic or pulmonary diseases or conditions, muscular-skeletal injuries (i.e. spine, knees, hips or shoulders, taking medications that affect endocrine or cardiovascular function, hypertension, being engaged in moderate intensity exercise more than two times per week or moderate-high intensity training of any type and frequency, being pregnant, cigarette smoking, having non-removable pieces or devices incompatible with DXA and CMR assessment
Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With Metformin in Healthy Male Adults (Phase 1 Study)

The purpose of this study is to evaluate drug-drug interaction of DWP16001 in combination with metformin IR 1000mg in Healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male adults aged 19 to 50 years at the time of screening test
* 55.0 kg ≤ Body weight ≤ 90.0 kg and 18.0 ≤ Body Mass Index (BMI) ≤ 27.0
* Written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study
* Eligible to participate in the study at the discretion of the investigator by physical examination, laboratory test, and history taking, etc.

Exclusion Criteria:

* Current or history of clinically significant hepatic, renal, nervous, respiratory, endocrine, hemato-oncology, cardiovascular, urogenital, psychosis disorder
* Current or history of gastrointestinal disorders or prior history of gastrointestinal surgery that may affect safety and PK/PD assessment of the study drug
* Hypersensitivity or medical history of clinically significant hypersensitivity to a drug containing an ingredient of the investigational product (DWP16001), Dapagliflozin, Metformin or similar ingredient or other drugs (e.g., aspirin, antibiotics, etc.)
* Clinical laboratory test values are outside the accepted normal range at screening
* Other exclusive inclusion criteria, as defined in the protocol
Preferences for Certainty Versus Access When Evaluating New Cancer Drugs. A Discrete Choice Experiment.

To provide timely access to new treatments, some eligible drugs can be approved despite uncertainty surrounding the level of clinical benefit they offer patients.

It is not currently known if (and under which circumstances) people would prefer to wait to access some new drugs in exchange for greater certainty surrounding their clinical benefit.

This study aims to elicit the preferences of people in the US with experience of cancer for wait times and clinical uncertainty of new drugs.

To elicit this information, in a survey format, respondents will be presented with a hypothetical scenario and asked to state their preferences for new treatments, each with different attributes.


Eligibility Criteria:
Inclusion Criteria:

* Individuals previously or currently diagnosed with any type of cancer.
* Individuals with immediate family members previously or currently diagnosed with any type of cancer.

Exclusion Criteria:

* Individuals without previous or current diagnosis with any type of cancer (themselves or immediate family members).
Interventional Study Collecting Quantitative and Qualitative Data About Patient With Non Treated Cancer

This study aims to determine the impact of sociocognitive and emotional factors on the time of the initial consult

identify wich sociocognitive factors influence the delay to go to a doctor after the emergence of first symptoms

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* oral cavity cancer, oropharynx cancer, hypopharynx cancer, larynx cancer
* non treated cancer
* patient informed of his diagnosis
* speak fluent french
* patient covered by health insurance
* signed informed consent

Inclusion Criteria for "interviewed " patients :

* no speech troubles
* patient consents being recorded

Exclusion Criteria:

* history of cancer
* psychological history
* patient under guardianship
Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate

Our project is a 24-month longitudinal randomized controlled trial that aims to investigate the myopia development after topical application of 0.01% atropine in children with either fast or slow myopia progression classified according to their initial electro-retinal responses. This will help elucidate the effectiveness of using low concentration atropine for myopia control in children with different myopia progression rates.


Eligibility Criteria:
Inclusion Criteria:

* Age between 7 and 10 years
* Good general health and no family history of ocular diseases
* No current or history of epilepsy or asthma
* Myopia : -0.50 to -1.00 D (inclusive, both eyes)
* Astigmatism : ≤ 0.50 D
* No hyperopia, amblyopia or strabismus
* No reported ocular eye diseases or disorders
* No drug allergy
Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy - Observational Long-term Outcome Follow up

Subjects previously enrolled / randomized in the ReActIF-ICE (Recovery from acute immune failure in septic shock by immune cell extracorporeal terapy - immune competence enhancement) study received either standard sepsis treatment (control group) or standard sepsis treatment and additionally the ARTICE treatment (treatment group) during their index hospitalization. All subjects are followed up for 90 days after enrollment.

In this long term follow up study, the enrolled subjects shall be followed up beyond 90 days for up to 5 years.

Sepsis is a worldwide health threat because of high mortality and the development of long-lasting disabilities, including physical and cognitive impairment and mental disorders, known collectively as post-intensive care syndrome (PICS), which contribute to reduced health-related quality of life (HRQoL) for several years even after successful recovery from the initial acute sepsis state. Sepsis survivors often need a longer period of rehabilitation, consuming more medical and social resources and struggle with financial burdens.

In the ReActIF-ICE study, that started enrolling patients in July 2022, up to 142 subjects with severe sepsis are to be enrolled and randomized into a therapy group (receiving the ARTICE treatment (extracorporeal immune cell plasma perfusion) on top of standard care) and control group (standard care only). These subjects were followed up according the ReActIF-ICE study protocol for 90 days.

Since there is still a large need for long-term outcome data of sepsis patients, collecting data of the ReActIF-ICE patients over a longer period of time would provide important additional information regarding:

1. General long term clinical and socio-economic outcome of sepsis survivors
2. Long-term outcome details of the ReActIF-ICE patient population
3. The potential long-term medical outcome effects of the additional ARTICE treatment compared to standard treatment alone.
4. The potential long-term health-related quality-of-life effects of ReActIF-ICE patient population
5. The potential long-term health-related quality-of-life effects of the additional ARTICE treatment compared to standard treatment alone.

In this long term follow up study, the enrolled subjects shall be followed up beyond 90 days for up to 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Subject or legal surrogate is willing and able to provide written informed consent and comply with all protocol requirements or the implementation of other established procedures according to the local regulations of the contributing center to include subjects who are unable to provide informed consent.
2. Subject was enrolled in the ReActIF-ICE study and successfully passed the Day 2 re-evaluation of that trial.

Exclusion Criteria:

* none
Enhanced Linkage Maps From Family-Based Genetics Studies

To develop genetic maps for the genome-wide screening markers used by multiple investigators and to investigate map differences between sexes and different ethnic groups.

BACKGROUND:

Meiotic linkage maps are the foundation of both linkage and linkage disequilibrium studies for mapping disease genes. Despite the importance of precise maps, existing genome-wide linkage maps were built using only a small collection of pedigrees, and so have wide confidence intervals surrounding estimates of map distance. Incorrect marker order and map distances can have a profound effect on linkage analyses. Using a sex-averaged map instead of a sex-specific map biases the lod scores upward, markedly increasing the false positive rate. Since it is very costly to follow-up many false-positive results, there is a clear need for more precise and accurate sex-specific genetic maps. Accurate estimates of meiotic map distance cannot be obtained by any means other than by linkage analysis using genotype data.

The study is in response to a Request for Applications entitled "NHLBI Innovative Research Grant Program" released in July, 2001. The purpose of the initiative is to support new approaches to heart, lung, and blood diseases and sleep disorders that use existing data sets or existing biological specimen collections whether obtained through National Heart, Lung, and Blood Institute support or not.

DESIGN NARRATIVE:

The genetic epidemiology study will build improved highly-precise sex-specific linkage maps utilizing thousands of individuals who have previously been genotyped. After filtering out obvious relationship and genotype errors, the study will incorporate methods that properly model for genotyping errors. In addition to creating precise maps for the scientific community, the study will also use these genotype data to study how recombination may vary between ethnic groups. The genotypes generated by the NHLBI Mammalian Genotyping Service are precisely the type of data required to produce more accurate maps. These data collections contain over 3,400 pedigrees with more than a 100-fold increase in information compared to that contained in the 8 CEPH families that have been used to construct current genome-wide linkage maps. The new maps will be made publicly available and the genotype data from the study will be accessible by the MAP-0-MAT linkage mapping server. In the future, the study will be broadened to incorporate genotype data from additional genotyping centers such as the Center for Inherited Disease Research (CIDR).

Eligibility Criteria:
No eligibility criteria
Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period

Delirium (acute confusion) is a highly prevalent condition among hospitalized elders with substantial morbidity within the hospital and beyond. Particular patient populations are at high risk for poor outcomes after an episode of delirium. Patients with hip and other long bone fractures are at increased risk of developing delirium (acute confusion) which impedes functional recovery. This is a pilot study to test the tolerability and efficacy of donepezil, a cholinesterase inhibitor medication used commonly in persons with dementia, for the prevention of new or worsening delirium in aged hip and other long-bone fracture patients. Additional purposes involve gathering a small amount of patients' serum to better understand the pathophysiology of delirium in this population.

The purposes of this pilot study are to determine: 1) the safety and tolerability a cholinesterase inhibitor medication) in aged hip and long bone fracture patients, 2) To obtain estimates of subject accrual and preliminary estimates of effect size on the development of new delirium symptoms to allow for planning of a larger, definitive trial, 3) To better understand the underlying causes of delirium by examining whether a measure of blood anticholinergic activity relates to the incidence and persistence of delirium symptoms, and 4) To explore the interaction between anticholinergic activity, donepezil therapy, and delirium symptoms.


Eligibility Criteria:
Inclusion Criteria:

* hip or other long bone fracture undergoing operative repair
* age of 70 years or older
* the ability to communicate effectively in English (including adequate hearing)
* residence within a 50 mile radius of the BIDMC
* life expectancy 6 months or greater
* not currently on cholinesterase inhibitor therapy
* not with known hypersensitivity to cholinesterase inhibitors
* not a previous study participant or refusal

Exclusion Criteria:

* patients with sick sinus syndrome or greater than 1st degree AV block without a pacemaker
* patients with a pathologic fracture due to metastatic cancer
* patients with advanced dementia or total functional dependence.
The Effect of Acupressure on the Sleep Quality and Fatigue

This research aims to determine the effect of acupressure applied to nurses actively working in internal clinics on sleep quality and fatigue during the COVID-19 pandemic process. This research hypothesizes that acupressure improves sleep quality and reduces fatigue.

In this study, 68 nurses working in internal clinics were randomly assigned to acupressure and placebo (sham) acupressure groups. In the acupressure group (n=34), the heart meridian 7th point (HT7), large intestine meridian 4th point (LI4), stomach meridian 36th point (ST36) and spleen meridian 6th point (SP6) will be applied to a total of four points. Depending on the preparation and compression time on each point, the session duration of each nurse will be 20 minutes on average. In the sham group (n=34), pressure will be made approximately 1-1.5 cm away from the HT7, LI4, ST36, SP6 points. In the Sham group, the acupressure application time will take 20 minutes on average. Reminder text messages (SMS) will be sent before the application on the days when the nurses will practice, so that they continue to do the application regularly. At the end of the application, after the data collection process is completed, the sham group will be taught the correct acupressure points. Nurses will apply acupressure three times a week for a total of 12 sessions for four weeks. The primary outcome of the research is the effect of acupressure on the sleep quality of nurses. The secondary outcome of the study is to determine the effect of acupressure on fatigue. The outcomes will be collected before and four weeks after the acupressure and sham acupressure administration.

Eligibility Criteria:
Inclusion Criteria:

Nurses who care for COVID 19 patients during the pandemic process

Nurses working in internal clinics during the data collection process

Those who have recovered from COVID 19

Those who agreed to participate in the study

No deformity or lesions in the areas where acupressure will be applied

No acupressure experience

No sleep disorder diagnosis and no medical treatment

Not diagnosed with anxiety disorder and not receiving medical treatment

Not diagnosed with depression and not receiving medical treatment

Coffee, cigarette and alcohol free

No mental disorder

Night shift workers

Those who can understand and speak Turkish

Those who signed the Informed Consent Form

Exclusion Criteria:

Nurses who did not work in internal clinics during the data collection process

Nurses who do not care for COVID 19 patients during the pandemic process

Those with active COVID 19

Those who do not agree to participate in the study

Those who have any deformity or lesion in the areas where acupressure will be applied

Experiences of acupressure

Heart and kidney failure, severe anemia, immunodeficiency problem

Pregnant

Diagnosed with sleep disorder and receiving treatment

Anxiety disorder and treatment

Depression diagnosed and treated

Coffee, cigarette and alcohol addiction

Having mental illness

Fixed day shift workers

Those who can not understand and speak Turkish

Those who did not sign the Informed Consent Form
Comparison of Direct Anterior and Posterior Surgical Approaches in Regards to the Patient' Physical Characteristics

Recent increased interest in tissue-sparing and minimally invasive arthroplasty has given rise to a sharp increase in the utilization of direct anterior total hip arthroplasty.

* Purpose: The direct anterior approach to the hip has been suggested to have several advantages compared to previously classical approaches. However, no studies focused on the effects of these different surgeries on patients' perception recovery and walking efficiency according the initial physical fitness. Therefore, the purpose of this study is to compare the effects of surgical procedures on perceptual walking skills and efficiency according to the patients' physical fitness.
* Abstract : Some earlier studies report differences between surgery types in self- reported mobility, functional recovery and residual hip pain. The direct anterior approach to the hip has been suggested to have several advantages compared to previously popular approaches through its use of an intra-muscular and intra-nervous interval between the tensor fasciae latae and sartorius muscles. However, patients' physical fitness, postural response and perceptual walking skill relation was not taking account. 80 patients will be tested, one before and at various times after hip surgery. In randomized conditions, our patients will be divided in two groups, according the surgery approaches and their physical fitness. All patients performed a Performance-Oriented Mobility Assessment Walking test with and without step and the PMA, Harris, Oxford 12 and Womac scores will be evaluated before, 3 weeks, 6 weeks, 3 months and 1 year after the surgery. During the Performance-Oriented Mobility Assessment Walking test, self-reported walking capacity, rating of exertion perception and walking parameters will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 50 years
* Body mass index \< 35
* Scheduled hip arthroplasty surgery
* Exclusion Criteria:
* No health coverage
* Age \> 85 years
* Body mass index ≥ 35
* Cognitive impairment (score Mini Mental Statue \< 24)
* Any other osteo-articular diseases than the operated hip, any muscular or neurological diseases that could penalize the walk
Study of Inhaled Glucocorticosteroid Administration in Asthma Patients

Once-daily inhaled glucocorticosteroids treatment can sufficiently control airway inflammation in asthma patients.


Eligibility Criteria:
Inclusion Criteria:

* Receive ICS for one year or more, with no change in dose within the previous 8 weeks

Exclusion Criteria:

* Two or more courses of oral corticosteroid in the previous 12 months
* Admission to hospital due to asthma in the previous 6 months
* Admission to the intensive care unit due to asthma at any time in the past
* Current cigarette smoker.
Safety and Performance Study of TIGR Matrix Surgical Mesh in Inguinal Hernia Repair

This an open, uncontrolled multicenter clinical study to assess the safety and performance of the WK-6 surgical mesh in adult patients with unilateral inguinal hernia.

The primary objective is to determine the safety of the WK-6 surgical mesh. Data will be compared retrospectively with published studies on inguinal hernia mesh.

The secondary objectives are to explore the performance of the surgical mesh by measuring the pain pre and post surgery as well as a number of relevant variables for establishing the performance of the mesh. Data will be compared retrospectively with previous studies on inguinal hernia mesh with a follow-up of at least one year.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have given informed consent
* Male, 18 years and older.
* Patients with primary unilateral inguinal hernia
* Planned surgery procedure according to Lichtenstein technique

Exclusion Criteria:

* Patients who are unwilling and/or unable to give informed consent
* Hernia strangulated or irreducible
* Recurrent Hernia
* Previous mesh surgery on the same side
* Class \>IIa patients
* Unable to walk 500 meters
* BMI \>30 kg/m2
* Warfarin treatment, ongoing or within two weeks of surgery.
* Peripheral artery disease
* Chronic back pain, as judged by the investigator.
* Hip joint arthrosis
* Hypermobility syndrome, as judged by the investigator.
* Constipation
* Drug or alcohol abuse
* COPD (chronic obstructive pulmonary disease)
* Patients at increased risk of death from a pre-existing concurrent illness
* Patients participating in another clinical study
* Patients who have used any other investigational drug or device within 1 month
* Patients who cannot communicate reliably with the investigator
* Patients who are unlikely to cooperate with the requirements of the study
* Patients who are employees at the investigational site; relatives or spouse of the PI.
* Patients not suitable based upon investigator decision
A Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis

This is a Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis.


Eligibility Criteria:
Inclusion Criteria:

1. Age 45 years or older of either gender and of any racial/ethnic group.
2. Subjects must be in generally good health.
3. Subjects must be able and willing to comply with the requirements of the protocol.
4. Must be diagnosed with RRMS
5. Meets the criteria to enter Group 1 or Group 2

Exclusion Criteria:

1. Subject is currently in middle of an active episode of an autoimmune condition (e.g. rheumatoid arthritis, system lupus erythematosis)
2. Subject currently has a condition such as active influenza that would stimulate the immune system
Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate

The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.


Eligibility Criteria:
Inclusion criteria Patients with non-valvular atrial fibrillation (AF), at moderate to high risk of stroke, or systemic embolism with at least one additional risk factor (i.e. previous ischemic stroke, TIA, or systemic embolism, left ventricular dysfunction, age \>=75 years, age \>=65 with either diabetes mellitus, history of coronary artery disease or hypertension)

Exclusion criteria

1. Prosthetic heart valves requiring anticoagulation per se, or hemodynamically relevant valve disease that is expected to require surgical intervention during the course of the study
2. Severe, disabling stroke within the previous 6 months, or any stroke within the previous 14 days
3. Conditions associated with an increased risk of bleeding
4. Contraindication to warfarin treatment
5. Reversible causes of atrial fibrillation (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism).
6. Plan to perform a pulmonary vein ablation or surgery for cure of the AF
7. Severe renal impairment (estimated creatinine clearance \<=30 mL/min)
8. Active infective endocarditis
9. Active liver disease
10. Women who are pregnant, lactating, or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study
11. Anaemia (haemoglobin \<100g/L) or thrombocytopenia (platelet count \<100 x 109/L)
12. Patients who have developed transaminase elevations upon exposure to ximelagatran
13. Patients who have received an investigational drug in the past 30 days or are participating in another drug study
14. Patients considered unreliable by the investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration, has a life expectancy less than the expected duration of the trial due to concomitant disease, or has any condition which in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse)
15. Any known hypersensitivity to galactose if the warfarin used contains galactose.