cyrilzakka/clinical-trials huggingface dataset:
Comparison of Physical Activity Regimens as Treatments for Obstructive Sleep Apnea

The purpose of this study is to compare the efficacy of two different physical activity regimens as complementary or alternative treatment options for the treatment of obstructive sleep apnea. A secondary purpose of the study is to examine the effects of these activity regimens on various health consequences of obstructive sleep apnea, including blood pressure, systemic inflammation, and daytime functioning.


Eligibility Criteria:
Inclusion Criteria:

* moderate-intensity obstructive sleep apnea (AHI \>= 15)
* sedentary status

Exclusion Criteria:

* current treatment for obstructive sleep apnea (CPAP, oral devices, etc.)
* significant cardiovascular, pulmonary, or metabolic disease
* uncontrolled hypertension
* inability to exercise (e.g., musculoskeletal, neuromuscular, orthopedic problems)
Comparing Different Surgical Techniques for Coverage of Pressure Ulcer

The Plastic, Reconstructive and Aesthetic Surgery department of Montpellier was born out of the Wound and Healing department, the first unit of this type to be created in Europe. The investigators quickly became the national leader in the management of pressure ulcers, especially in people with spinal cord injuries.

Our expertise has evolved over time as well as our surgical techniques for covering ulcers, gradually over time the investigators have gone from " random " flaps to " propeller " flaps, more reliable in terms of vascularization and more logical in terms of force distribution and skin tension.

The investigators found subjectively that the rate of complications was lower for the helical flaps. The investigators therefore seek to confirm this trend through a retrospective study on patients operated on in the department between January 1, 2015 and December 31, 2019.


Eligibility Criteria:
Inclusion criteria:

* Major Patient
* Patient with trochanteric, ischiatic or sacral pressure ulcer
* Patient who undergone flap surgery for pressure ulcer between January 1st, 2015 and December 31st, 2019

Exclusion criteria:

* Other loss of substance than pressure ulcer
* Combined covering with a random flap and a propeller flap
* Surgical revision of a flap without a new flap
Prognosis Predictors for Heart Failure

This study is looking for the predictors of the survival or rehospitalization of patients with heart failure with reduced ejection fraction. Participants who are discharged from an acute heart failure hospitalization are enrolled.

This study is looking for the predictors of the survival or rehospitalization of patients with heart failure with reduced ejection fraction. Participants who are discharged from an acute heart failure hospitalization are enrolled. The prognostic factors provide information about the treatment of this disease in the future. This study is a retrospective observational study. Investigators will collect data from May 2014 to July 2019 in the heart failure center of Kaohsiung Chang Gung Memorial Hospital. A follow-up is conducted at the Kaohsiung HF center until August 2020. Investigators want to know whether the risk factors such as atrial fibrillation, diabetes, nephropathy, and some biochemical indexes can be an index that predicts future survival or rehospitalization of these patients. Besides, investigators will also explore the cardiac rehabilitation can also effectively improve the survival rate of such patients.

Eligibility Criteria:
Inclusion Criteria:

* inpatient, age \>= 20 years old, male or female
* patient with heart failure with a reduced ejection fraction and discharged alive from the hospital
* received heart failure disease management program

Exclusion Criteria:

* Estimated survival time \< 6 months
* Long-term bedridden for more than 3 months
* Cannot tolerance exercise test due to muscular-skeletal disorder
* Cannot co-operate all functional studies
* Ventilator dependent
* Terminal heart status
* The family reject to participate in this project
Clinical Study of Excimer Laser and Drug Coated Balloon Versus Excimer Laser and Plain Balloon Versus Plain Balloon and Drug Coated Balloon to Treat Femoropopliteal In-stent Restenosis

This is a randomized study comparing Excimer laser and drug coated balloon Versus Excimer laser and plain balloon versus plain balloon and drug coated balloon to Treat femoropopliteal in-stent restenosis

This is a randomized study comparing Excimer laser and drug coated balloon Versus Excimer laser and plain balloon versus plain balloon and drug coated balloon to Treat femoropopliteal in-stent restenosis

Eligibility Criteria:
Inclusion Criteria:

Provides written informed consent Willing to comply with follow-up evaluations at specified times Has claudication or rest pain due to peripheral arterial In-stent restenosis Disease located within the femoropopliteal artery Patient has a In-stent restenosis lesion(s) with \>50% stenosis documented angiographically Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 or greater.

Exclusion Criteria:

They were excluded if they had one or more of the following: 1. Acute or subacute lower limb ischemia; 2. Severe calcification lesions; 3. Total occlusions lesions more significant than 10 cm or total occlusion lesions with a suspicion of subintimal wire recanalization 4. untreated ipsilateral iliac artery stenosis\>70%, or the distal runoff artery \<1 root; 5. Previously lower extremity intervention or surgical graft artery bypass; 6. Severe renal insufficiency, creatinine level greater than 2.5 mg/dL; 7. The patient's platelet count is less than 100,000/uL, antiplatelet or anticoagulant contraindications to required medications; 8. Patients with immune system diseases or malignant tumours; 9. ongoing active infection 10. decompensated congestive heart failure or acute coronary syndrome; 11. Unwillingness to return for future follow-up visits
Iodinated Contrast Agents and Risk of Hypothyroidism in Young Children in the United States

This study will estimate the incidence of hypothyroidism in a pediatric population of children under age 4, based on data from the US-based Kaiser Permanente Northern California database, which were exposed to iodinated contrast agent through having a diagnostic procedure.


Eligibility Criteria:
Inclusion Criteria:

* Children under age 4 in the Kaiser Permanente Northern California (KPNC) database, who had a diagnostic procedure with an iodinated contrast agent.
* Participants should be member of the KPNC for at least 3 months before the iodinated contrast exposure, except where the child is under 3 months of age at time of initial exposure, and 2 weeks after the exposure.

Exclusion Criteria:

* Diagnosis of hypothyroid any time prior to the iodine contrast exposure.
* Lab values for low thyroid (TSH \> 5 mU/L for children) any time before the exposure
* Thyroid replacement therapy, Hashimoto thyroiditis, or congenital hypothyroidism any time prior to exposure.
Comparison Between Insulin Pump Treatment and Multiple Daily Insulin Injections in Diabetic Type 1 Children

Comparison between insulin pump treatment and multiple daily insulin injections in 38 children with type 1 diabetes4-16 years old. Outcome metabolic control, quality of life, impact of disease and cost effectiveness.

We hypothesised that insulin pump treatment would give a better metabolic control and quality of life.

The current standard of insulin treatment in type 1 diabetes is multiple daily insulin injection therapy (MDII). In the seventies, continuous subcutaneous insulin infusion (CSII) was introduced. CSII has been gaining popularity, perhaps because of technical advances resulting in improved patient comfort. In children five randomised studies(1-5) were completed to compare MDII and CSII. No data were gained about quality of life and impact of disease.

In our trial we focussed on quality of life next to metabolic control.

The trial was an open-labelled,randomised trial. Both efficacy and safety data were collected. The trial started with a 14 weeks run in phase, during all patients started MDII.In the following randomisation phase patients were randomised to continue MDII or to CSII.This phase lasted 14 weeks.In the phase thereafter all patients used CSII for 14 weeks. The trial was concluded by a 14 weeks allocated patient preference phase.

Patients were type 1 diabetic children 4-16 years old with poor metabolic control.hypothesis: better metabolic control in CSII, better quality of life in CSII.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes,
* Diagnosed by the presence of IA-2,
* GAD-65 or islet cell cytoplasmatic auto antibodies,
* Daily insulin adminstration or 1 year of longer,
* Random C-peptide \<200 pMol,
* Hba1c\>8.0% and/or a history of repeated symptomatic hypoglycaemias,
* Attending regular school

Exclusion Criteria:

* Clinical manifest chronic complications,
* Pregnancy,
* Co-morbidity,
* Mental retardation,
* Psychiatric treatment or symptoms in child or parent,
* Insufficient Dutch language capabilities and absence of telephone at home
Therapeutic Effects of the Processing of Positive Memories Technique on Posttrauma Health

The current study will examine daily-level impacts of a technique addressing positive memory retrieval on thoughts, feelings, and health among individuals with trauma experiences.

Post-traumatic stress disorder (PTSD) is primarily a memory encoding- and retrieval-based disorder. If untreated, there are significant physical, psychological, social, and economic impacts for an individual, their families, and the society broadly. Research demonstrates that positive memory processes contribute to the etiology and maintenance of PTSD symptoms. Indeed, difficulties in retrieving and discussing positive memories are amplified among individuals with PTSD. Further, interventions capitalizing on (positive) memory retrieval have been linked to enhanced psychological well-being.

Considering this literature, the Processing of Positive Memories Technique (PPMT) was developed as a promising new treatment approach for posttraumatic stress disorder (PTSD), which involves detailed narration and processing of specific positive autobiographical memories. This study uses an innovative research protocol that combines case-series design and daily diary approaches to the effects of PPMT on daily affect, daily cognitions, and daily PTSD symptoms. It is hypothesized that at the daily level, in comparison to their an individual's pre-PPMT levels, following the PPMT intervention, participants will report (1) a lower count of endorsed daily PTSD symptoms, (2) increases in daily positive affect and decreases in daily negative affect, (3) increases in positive affect reactivity to daily positive events, and (4) decreases in daily posttrauma cognitions.

Eligibility Criteria:
Inclusion Criteria:

* being aged between 18 and 65 years
* endorsing a trauma with posttrauma symptoms
* access to an electronic device with internet capabilities
* working knowledge of English
* being a current resident of the Dallas Fort Worth metroplex
* willingness and availability to participate in approximately 10 weeks of this study (including 4 therapy sessions)
* willingness to be video-recorded during sessions for quality control purposes

Exclusion Criteria:

* active suicidal plan, suicidal attempt, homicidal plan, or homicidal attempt (past 3 months including current)
* currently in therapy with a mental health provider
The Effects of VisionPure™ on Indices of Vision Health and Cognitive Function

VisionPure™ is a softgel dietary supplement containing fish oil, lutein, zeaxanthin, and vitamin D. The intent of the VisionPure product is to assist in maintaining eye and cognitive health while helping to provide protection against blue throughout the day. In this pilot trial, approximately 16 participants will be recruited and randomly assigned to experimental and placebo conditions. Participants will consume 1 serving (2 softgels) per day of their respective study condition for 60 days. Prior to and following the 60 day supplementation period, participants will undergo a series of optometry and cognitive examinations to quantify eye health and cognitive function outcomes.

The study design is a randomized, double-blind, placebo-controlled, parallel design, pilot trial. In this pilot trial, approximately 16 participants will be recruited and randomly assigned to experimental and placebo conditions. Participants will consume 1 serving (2 softgels) per day of their respective study condition for 60 days. All study-related procedures will be carried out at 2 locations, The Applied Science and Performance Institute, as well as at True Eye Experts. Both locations are in Tampa, FL. All screening for the study and the signing of all IRB documents will be held at the Applied Science and Performance Institute. Optometry eye examination at Day 0 and Day 60 will be conducted under the supervision of a board-certified O.D. at the True Eye Experts location. Computer-based cognitive assessments using a program called CNS Vital Signs will be carried out at Day 0 and Day 60 at the Applied Science and Performance Institute. The following exams will be carried out: Verbal Memory, Visual Memory, Composite Memory, and Cognitive Attention.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 18-40 years
* English literate
* Willing to sign informed consent form

Exclusion Criteria:

* Current cataracts or prior cataract extraction
* Glaucoma
* Uveitis
* Macular hole or traction
* Retinitis pigmentosa
* Significant epiretinal membrane
* Dry eye syndrome of any form
* LASIK procedure
* Diagnosed concussion within the last 6 months
* Optic neuropathy
* Neurological disease
* Metabolic disease
* Cardiovascular disease
* Renal disease
* History of previous ocular surgery, trauma, intraocular injections or photocoagulation
* Vitamin D3, omega fatty acids, or fish oil supplementation with the last 6 months
Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis.

Patients who present rhizarthrosis diagnostic will be randomized to be treated with chondroitin sulfate or placebo during 24 weeks to study the effect of the treatment with objective and subjective indicators of pain and sensibility.


Eligibility Criteria:
Inclusion Criteria:

* both sex patients
* age between 45 to 75 years
* with mechanical pain at the trapezium-thumb metacarpal joint of more than 3 months duration
* grade II or III Eaton \& Glickel rhizarthrosis radiological diagnose
* pain at inclusion of \>= 40 mm at a visual analogue scale
* without rehabilitation treatment or infiltration in the last 6 months
* who accept to participate and sign informed consent

Exclusion Criteria:

* patients with rhizarthrosis resulted from rheumatic disease
* patients with joint surgery or traumatic background
* illiterate patients or unable to understand informed consent
* patients with previous neuropsychopathology enough severe to unable participation at the study
* patients with peripheral sensory impairment due to diabetes, peripheral neuropathy or central neurological sequelae of disease in the affected limb that can alter sensory perception
* patients with coagulopathy
* inflammation for other process at the joint at study
* in treatment with non-steroidal anti-inflammatory drug in the last 7 days and/or corticosteroid in the last 30 days
* allergy or hypersensibility at chondroitin sulfate or its excipients
* pregnant or breastfeeding woman
Evaluation Study on Corneal Lens for Vision Correction

The objective of this study is to evaluate the fitting and visual outcomes of Nexis Lens, made of silicone commonly used in the contact lens industry, on healthy eye with or without astigmatism.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with good corneal health
2. Age 18-65.
3. Patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements.
4. Best corrected visual acuity of 20/20 or better in the study eye/s

Exclusion Criteria:

1. Any other anterior segment abnormality.
2. No previous corneal procedures, including Laser Vision Correction.
3. Any abnormalities associated with the eye lids.
4. Clinically significant inflammation or infection within six (6) months prior to study.
5. Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator.
6. Participation in any study involving an investigational drug or device within the past 30 calendar days, or ongoing participation in a study with an investigational material except studies using corneal lenses.
7. Intolerance or hypersensitivity to topical anesthetics, fluorescein, or components of the material.
8. Specifically known intolerance or hypersensitivity to contact lenses.
9. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.
Official Record of Patients Diagnosed With Lymphangioleiomyomatosis (LAM)

Pulmonary lymphoangioleiomyomatosis (LAM) is a rare destructive lung disease typically affecting women of childbearing age. Currently, there is no effective therapy for the disease and the prognosis is poor.

In order to better study this disease, the National Heart, Lung, and Blood Institute (NHLBI) has developed a registry to keep an official record of patients diagnosed with LAM. This research project will collect data from 6 health care centers as well as outside physicians. Researchers hope to provide valuable information about the rate of lung destruction and quality of life in patients with LAM.

Patients participating in this study will be followed for 5 years. Tissue collected from these patients may contribute to the development of future studies on the disease processes of LAM.

LAM is a rare disease that predominantly affects women of child-bearing age. To study in more detail this rare disease, this multi-center project will establish a registry of persons with LAM. By combining data from 6 centers and outside physicians, this study may yield valuable information regarding the rate of decline in pulmonary function and quality of life in individuals with LAM. These patients will be followed over a five-year period. Tissue collected from study participants may facilitate future studies into the molecular basis of LAM.

Eligibility Criteria:
Informed consent must be obtained from the patient.

Patients must be female.

Patients must be age 18 or older.

Patients with prevalent and incident cases are eligible.

Patients with the presence or absence of underlying diagnosis or evidence of Tuberous Sclerosis Complex (TSC) are eligible.

Patients must have a diagnosis of LAM confirmed by any of the following criteria:

Lung biopsy (transbronchial, surgical, transthoracic) judged to be diagnostic by the Tissue Core pathologists;

OR

Biopsy of lymph node or other mass judged to be diagnostic by the Tissue Core pathologists;

OR

High resolution CT scan of the chest which is judged to be diagnostic of LAM with a high degree of certainty by all three of the expert radiologists making up the Imaging Core.

Patients may be enrolled in other protocols.
Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension

The primary objective of this trial is to demonstrate that following eight weeks of treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing mean seated trough cuff Systolic Blood Pressure \[SBP\] compared to the monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe hypertension. A key secondary objective is to identify the duration of treatment required to demonstrate the superiority of the FDC over both of the monotherapies.


Eligibility Criteria:
Inclusion criteria

1. Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation
2. Age 18 years or older
3. Patients with severe hypertension as defined SBP greater than 180 mmHg and DBP greater than 95 mmHg at randomisation
4. Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigators discretion)

Exclusion criteria Mean in-clinic seated cuff SBP \>/= 200 mmHg and/or Diastolic Blood Pressure \[DBP\] \>/= 95 mmHg
Exercise-Induced Gut Permeability in Normal-weight Obesity

Exercise acutely increases gut permeability and inflammation, even in healthy populations. However, whether this response differs in groups at-risk for CVD that present with low-grade inflammation (e.g., normal-weight obesity) has yet to be examined. The investigators aim to measure serum indicators of gut permeability in those with normal-weight obesity pre- and post-short, intense exercise and sustained, moderate exercise

The investigator's overall goal is to examine how indicators of gut permeability change in response to exercise in individuals with normal-weight obesity (i.e., normal body mass index \[BMI\] and high body fat percent) relative to those with a normal BMI and low body fat percent and those with a BMI in the obesity range and high body fat percent.

The investigators will examine indicators of gut permeability (specified in primary outcomes) in response to a short, intense bout of exercise (i.e., VO2 max test on a cycle ergometer) and sustained, moderate bout of exercise (i.e., 45 minutes at 65% measured VO2 max on a cycle ergometer).

Additionally, the investigators will measure basic anthropometrics, blood lipids and glucose, and body composition with DXA.

Eligibility Criteria:
Inclusion Criteria:

Control group: normal BMI, body fat percentage \< 25% (male) or \< 35% (female)

Normal-weight obesity: normal BMI, body fat percentage \> 25% (male) or \> 35% (female)

Overt obesity: BMI in obesity range, body fat percentage \> 25% (male) or \> 35% (female)

Exclusion Criteria:

* Presence of pacemaker
* Pregnant
* Postmenopausal status
* History of chronically using of tobacco products, illicit drugs, anti-inflammatory drugs (e.g., NSAIDs), lipid lowering drugs
* Recent use of antibiotics (\< 6 weeks) and NSAIDs (\< 3 days)
* Established cardiometabolic disease (e.g., cardiovascular disease, type 2 diabetes) diseases inflammatory in nature (e.g., rheumatoid arthritis, inflammatory bowel disease), and/or diagnosed irritable bowel syndrome.