cyrilzakka/clinical-trials huggingface dataset:
OBese Patients With Obstructive Sleep Apnea Syndrome(OSAS) and EXercise Training

The study was designed to test the following hypotheses:

In obese patients with OSAS, the benefit of the combination of exercise training + continuous positive airway pressure (CPAP) will be higher than CPAP alone in term of functional capacity, metabolic, inflammatory, cardiovascular and sleep parameters and quality of life.

In obese patients with OSAS, the benefit of training using ventilatory assistance (NIV) during cycloergometer \[cycloergometer with NIV\] or respiratory muscles training (spirotiger) in addition to cycloergometer \[cycloergometer + spirotiger\] will be higher than cycloergometer training alone \[cycloergometer\] in term of functional and exercise capacities.

Dyspnea during walking test and respiratory muscle strength at baseline could influence the response to combined exercise training such as \[cycloergometer + NIV\] or \[cycloergometer + spirotiger\]

Background: Obesity and sleep apnea syndrome lead to metabolic troubles and increasing cardiovascular risk. Furthermore, both diseases are associated with reduced exercise tolerance. We hypothesized that exercise training could be complementary to nocturnal ventilatory treatment in restoring metabolic disturbances, exercise tolerance and sleep parameters in obese patients with SAS.

Objective: To evaluate the effect of training on exercise tolerance (walking distance and dyspnea during walk)(main objective), systemic inflammation, vascular endothelial function, insulin resistance, quality of sleep and quality of life in obese patients treated by CPAP for OSAS (secondary objectives)

Methods: We proposed to conduct a controlled, randomized clinical trial comparing the efficacy of 3 different modalities of training in obese patients with SAS. After a 6-week control pre-inclusion period, patients are included in either \[cycloergometer\] vs. \[cycloergometer with ventilatory assistance\] vs. \[cycloergometer + respiratory muscle exercises\]. Before and after the control period, and both immediately and 9 month after training, patients perform walking test, maximal incremental test on cycloergometer, blood sampling and cardiovascular function, body composition, muscle function, quality of sleep and quality of life assessments as well as spontaneous physical activity measurement. During the 5 years following inclusion in the training program, the number of cardiovascular event is recorded every year.

An interim analysis will be carried out when 30 will have completed the third evaluation session (after the training program). The Peto's method will be used to correct the p-values.

Eligibility Criteria:
Inclusion Criteria:

* OSAS (AHI \> 30 before CPAP treatment)
* \> 4h/d CPAP treatment adherence
* Obese patients with 35 \< BMI \< 45 kg/m2
* Patients who give written consent
* Patients who subscribed social insurance

Exclusion Criteria:

* Cardiovascular or respiratory failure discovered at the moment of the inclusion in the study
* Contraindication to exercise
* Pregnant or breast-feed woman
* Patients under guardianship
* Imprisoned patients
Vitamin D Reabsorption in Adolescents and Young Adults With HIV Infection

The purpose of this study is to test the effects of Vitamin D on renal phosphate and bone loss, which are common in HIV infected adolescents and young adults being treated with tenofovir.

ATN 063 tests the hypothesis that in a population of adolescents and young adults with HIV infection who are being treated with tenofovir as part of an antiretroviral (ARV) combination regimen, vitamin D supplementation will decrease renal phosphate loss, increase plasma phosphate, decrease plasma PTH, and improve markers of bone turnover, including a decrease in plasma N-telopeptide and BAP.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and 0 days through 24 years and 364 days
* HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA at any time prior to study entry
* Currently being treated with a stable FDA-approved ARV combination therapy, containing \> 3 antiretrovirals, for \> 28 days, according to HRSA guidelines. Treatment regimen will not be started or changed for the purposes of participation in this study. Subjects will be receiving therapy at the direction of their treating physician
* Willingness to remain on the same ARV combination therapy for the 12-week duration of the study
* Ability and willingness to participate in the study by providing written informed consent
* Willingness to be randomized to receive either vitamin D or placebo

Exclusion Criteria:

* Prior hypersensitivity to vitamin D
* History of arteriosclerosis, renal stones, glomerulonephritis, nephrotic syndrome, or hypercalcemia
* Lactation or current pregnancy
* Active therapy for malignancy
* Known presence of gastrointestinal disease that would interfere with drug administration or absorption
* Serological evidence of Hepatitis B surface antigen (HBsAg)
* Confirmed creatinine clearance \< 90 ml/min (calculated GFR from serum creatinine using the MDRD formula)
* Grade 3 or higher clinical toxicity
Intra- and Inter-fraction Changes in Radiation Therapy

Analysis to quantify intra-fraction, inter-fraction and post-treatment changes in tumor target volumes and surrounding normal organs in radiation therapy.

The accurate and detailed knowledge of the changes (e.g., anatomically/biologically intra- and inter-fraction changes) to be obtained from this study would allow the research team to determine how Adaptive Radiation Therapy (ART) should be performed for a given tumor site/type. Radiation oncologists then can choose a proper ART strategy for a given tumor type to account for the anatomic/biological intra- and inter-fraction changes, improving accuracy of radiation therapy delivery, and in turn reducing treatment related toxicities and/or improving tumor local control.

Eligibility Criteria:
Inclusion Criteria:

°Completed radiation therapy

Exclusion Criteria:

°Subjects who refuse voluntary participation
Management of Intracerebral Hemorrhage With Aminocaproic Acid - Pilot Study

This is single-arm, open-label, safety and feasibility pilot study of ɛ-aminocaproic acid in ICH patients.

Consecutive ICH volume with hematoma volume less than 30 mL by ABC/2 method presenting within 3 hours of symptom onset, meeting all inclusion criteria, and without exclusions will be consented and enrolled. Subjects will receive 5 grams of intravenous ɛ-aminocaproic acid over 1 hour, followed by the same at 1 mg/hour for 23 hours. Comupted tomography (CT) head will be done at 24 hours in order to follow hematoma size. Electrocardiogram, lower extremity venous Doppler and NIHSS will also be done at 24 hours. The patient will be followed in the clinic 30-90 days post discharge for functional status.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 years
2. Supratentorial ICH ≤ 30 mL in volume and seen on ≥ 2 slices on a 0.5 mm CT head
3. IVH involving \< 50% of the ipsilateral lateral ventricle will be allowed
4. Treatment initiated within 1 hour of baseline CT and 3 hours of onset or last known normal

Exclusion Criteria:

1. Baseline mRS ≥ 2
2. Infratentorial hemorrhage (brainstem/cerebellum)
3. Any supratentorial hemorrhage extending to the brainstem
4. ICH \> 30 mL
5. Patients who undergo surgical evacuation
6. Presenting outside of the 3 hour window
7. Intraventricular extension \> 1/2 of one lateral ventricle
8. Intraventricular extension into the 3rd or 4th ventricle, or the aqueduct or involving \>50% of the ipsilateral lateral ventricle
9. ICH due to trauma
10. ICH due to aneurysm of arteriovenous malformation
11. ICH due to underlying neoplasm or infectious mass
12. ICH due to Warfarin or other oral or intravenous anticoagulants
13. International normalization ratio \> 1.4
14. Life expectancy \< 1 year (prior to ICH onset); due to any cause.
15. History of recent ischemic stroke (within the past 3 months)
16. History of deep vein thrombosis or pulmonary embolism
17. History of recent myocardial infarction (within the past 3 months)
18. Known history of hypercoagulable state
19. History of cancer
20. Glomerular filtration rate \< 60 mL/min
21. Received any hemostatic therapy for any indication (last 14 days)
22. Received any investigational therapy in last 90 days
23. "Do Not Resuscitate" order in place or expected, advance directives that could limit aggressive treatment measures.
A Study to Investigate the Effects of ACT-541468 on Nighttime Respiratory Function in Patients With Mild to Moderate Obstructive Sleep Apnea

This study is conducted to investigate the effects of ACT-541468 on nighttime respiratory function in patients with mild to moderate obstructive sleep apnea


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
* Male and female subjects aged ≥ 18 years at Screening.
* Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Screening Visit 2 and on Day 1 pre-dose of the first period. They must agree to consistently and correctly use a highly effective method of contraception with a failure rate of \< 1% per year.
* Women of non-childbearing potential, i.e., postmenopausal, with previous bilateral salpingectomy, bilateral salpingo-oophorectomy or hysterectomy, or with premature ovarian failure, XY genotype, Turner syndrome, and/or uterine agenesis.
* Diagnosis of OSA according to the International Classification of Sleep Disorders documented by medical history and confirmed in a sleep laboratory in the context of diagnosing OSA within the last 3 years.
* Patient with mild to moderate intensity of OSA determined during OSA diagnosis and confirmed on the screening night PSG and defined as apnea/hypopnea index (AHI) ranging from 5 to \< 30.

Exclusion Criteria:

* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
* Pregnant or lactating women.
* Modified Swiss Narcolepsy Scale total score \< 0 at Screening, or history of narcolepsy or cataplexy.
* Subjects with clinically significant abnormality on the screening night PSG as per investigator judgment, including evidence of severe insomnia (i.e., sleep time \< 5 h) periodic limb movement disorder with arousal index ≥ 10/h, restless legs syndrome, circadian rhythm disorder, REM behavior disorder, parasomnia including nightmare disorder, sleep terror disorder, and/or sleepwalking disorder.
* Need for continuous positive airway pressure device or a dental appliance device within the preceding 7 days prior to Screening Visit 2 and during the course of the study, i.e., from Screening Visit 2 to EOS.
* Evidence of any other clinically significant active pulmonary disease such as chronic obstructive pulmonary disease (COPD) (as per Global Initiative for Obstructive Lung Disease), based on investigator's judgment.
* History of surgical intervention for obstructive sleep apnea, except nose surgery.
* SaO2 \< 90% during wakefulness or mean non-apneic SaO2 (i.e., outside events of apnea/hypopnea) \< 85% for \> 5 consecutive min during the screening night PSG.
Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth

Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. In singleton gestations a short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB.

The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with a short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on the use of cervical pessary in pregnancy or guidelines for management have been assessed.


Eligibility Criteria:
Inclusion Criteria:

* 18-50 years of age
* Singleton pregnancy (limits the participants to female gender)
* Short cervical length (less than or equal to 25 mm) on second trimester transvaginal ultrasound at 18-23 6/7 weeks gestation

Exclusion Criteria:

* Multiple gestation
* Prior spontaneous preterm birth 16-36 6/7 weeks
* Ruptured membranes
* Lethal fetal structural anomaly
* Fetal chromosomal abnormality
* Cerclage in place (or planned placement)
* Vaginal bleeding
* Suspicion of chorioamnionitis
* Ballooning of membranes outside the cervix into the vagina or CL = 0 mm on transvaginal ultrasound
* Painful regular uterine contractions
* Placenta previa
Evaluation of the Antipruritic Effect of PAC-14028 Cream in Skin Pruritus

The objective of this study was to find a clinically appropriate dose of PAC-14028 cream by comparatively evaluating the efficacy and safety of PAC-14028 cream of Amorepacific Corporation in patients with dermal pruritus.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients at the age of 20 to 65 years old (both inclusive)
* Pruritus test ≥ 5cm (10cm Visual Analogue Scale \[VAS\]) at baseline
* Eczema or dry skin on the study drug application site
* Women of childbearing potential should have a negative urine pregnancy test at screening and agree to employ an effective method of birth control (surgical sterilization or oral contraceptives, barrier method with spermicides, intrauterine device, etc.) during the study period.
* Voluntarily signed written informed consent forms for study participation.

Exclusion Criteria:

* Pruritus due to other medical (liver disease, renal failure, etc.), psychotic, or neuropathic causes rather than as a skin disease.
* Chronic skin diseases such as malignant tumor or chronic urticaria, among skin diseases.
* Simple pruritus caused by allergic substances such as scabies or insect bites.
* Presence of symptoms of generalized infection at the time of study participation.
* Previous local treatment or antibiotics administration for pruritus within 7 days prior to study participation.
* Previous use of oral steroids within 1 month and local steroids within 2 weeks prior to study participation.
* History of physical treatment for pruritus, including phototherapy, within 1 month prior to study participation.
* Patients who are treated with prohibited concomitant drugs or considered to inevitably require treatment with prohibited concomitant drugs during the study period.
* Renal function impairment with creatinine level
* Hepatic function impairment with aspartate aminotransferase (AST)/ alanine aminotransferase (ALT)
* Pregnant and lactating women
* Participation in another clinical study within 1 month prior to screening.
* Patients considered ineligible for study participation by the principal investigator or sub-investigator for other reasons; pruritus due to other medical (liver disease, renal failure, etc.), psychotic, or neuropathic causes rather than as a skin disease.
Utility of Lung Ultrasonography As a Predictor of Fast Track Extubation

Fast-tracking in cardiac surgery refers to early extubation to reduce costs and perioperative morbidity. The use of lung ultrasound is recently accepted as a tool in the assessment of several lung conditions. The aim of this study was to assess the use of lung ultrasound score as a quantitative method to assist in the decision of early extubation.

background: Fast-tracking in cardiac surgery refers to early extubation to reduce costs and perioperative morbidity. The use of lung ultrasound is recently accepted as a tool in the assessment of several lung conditions. The aim of this study was to assess the use of lung ultrasound score as a quantitative method to assist in the decision of early extubation.

Methedology: in this prospective, observational study, 45 pediatric patients who will go elective repair of congenital acyanotic heart diseases were included and were examined with Lung ultrasound together with arterial blood gases preoperative and postoperative and given a score range from 0-3 according to number of B lines in each region and sensitivity of post-operative lung ultrasound score to extubation within 6 hours was examined Demographic data: Patients' name, age, sex, diagnosis, relevant medical and surgical history. And Assessment data: Baseline arterial blood gases and lung ultrasound score assessment after induction of anesthesia and at the end of surgery.

Primary outcome will be the sensitivity of lung ultrasound scores immediately at the end of pediatric cardiac operation in prediction of extubation. and Secondary outcome will be correlation between lung ultrasound score and Po2/Fio2 ratio at the end of operation

Eligibility Criteria:
Inclusion Criteria:

* were Age 6 months to 7 years
* Patients suffering from Acyanotic congenital heart diseases.

Exclusion Criteria:

* Age is less than 6 months and more than 7 years,
* Preoperative mechanical ventilation,
* Preoperative inotropic support.,
* Trisomy 21,
* Patient with cyanotic heart diseases
* Coagulopathy INR \>1.5
Efficacy of Eye Movement Desensitization & Reprocessing vs Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan

This Randomized Controlled Trial will check the efficacy of Eye Movement Desensitization \& Reprocessing vs Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan

This Randomized Controlled Trial will check the efficacy of Eye Movement Desensitization \& Reprocessing vs Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan.

It will be a single blind multi-center RCT with two arms (EMDR and CBT). This study will broadly work on following aims:

1. Initially the comparative efficacy of EMDR and CBT (i.e., standard face-to-face protcols) will be determined on large scale in Pakistan by:

   1. Examining whether EMDR is non-inferior to CBT in the treatment of PTSD and its two comorbidities in Pakistan.
   2. Studying changes in the symptoms (i.e., reduction in the PTSD and comorbid symptoms with the passage of time) after administering EMDR and CBT. The level of change in the symptoms will ultimately help in determining the extent of effectiveness of both therapies.
   3. Examine the reciprocal relationship between PTSD and comorbid symptoms for knowing whether any reduction in the PTSD symptoms can help in reducing the comorbid symptoms after administering EMDR and CBT.
2. At the mean time work on the design and development of virtual EMDR and CBT therapies (i.e., Web-based and Mobile Applications) will also be started. The initial prototypes will be tested for its comparative efficacy. Later once the final versions will be developed then it will be also tested for its comparative efficacy on large scale in Pakistan.

Eligibility Criteria:
Inclusion Criteria:

reverse of the exclusion critera

Exclusion Criteria:

The following patients will be excluded:

1. Patients below the age of 15 years and above 60 years, since this study is neither on children nor on old aged patients;
2. Patients who can't move their hands and eyes/or can't perform basic movements;
3. Patients who are unconscious for longer periods and unable to recover consciousness;
4. Patients not meeting the basic screening criteria of PTSD/ PTSD is not the main problem;
5. Patients with severe intellectual impairments, since such patients are difficult to communicate
The Elderly ACS II Trial

The objective of this study is to compare reduced-dose prasugrel and standard dose clopidogrel in patients older than 74 years with ACS, including non-ST-elevation (NSTEACS) and ST-elevation (STEMI) patients, undergoing early PCI. The primary endpoint of the trial will be the one-year composite of (all-cause)death, myocardial infarction, stroke and re-hospitalization due to cardiovascular reasons or bleeding.


Eligibility Criteria:
Inclusion Criteria:

- Patients \>74 years of age hospitalized for an ACS, with or without STE, with an onset of symptoms during the previous 72 hours, and candidates to an early PCI.

* STEMI patients may be randomized upon first diagnosis, provided they do not meet any exclusion criteria. STEMI patients should not exceed 50 percent of the global population of the study
* Eligible NSTEACS patients may be randomized after coronary angiography. To be eligible, NSTEACS patients must have at least one of the following characteristics:

  * elevated troponin levels;
  * diabetes mellitus;
  * prior MI;
  * at least one new ischemic episode while on standard treatment during the index hospitalization;
  * ACS due to stent thrombosis.

Exclusion Criteria:

* History of stroke or transient ischemic attack (TIA)
* Gastrointestinal or genitourinary bleeding of clinical significance within 6 weeks prior to randomization.
* Hemoglobin level on admission \<10 g/dl, unless this is considered to be secondary to renal dysfunction or known myelodysplasia.
* Secondary causes of acute myocardial ischemia.
* Known current platelet count \< 90,000 cells/mL.
* Ongoing oral anticoagulant treatment or an INR known to be \>1.5 at the time of screening.
* Concomitant severe obstructive lung disease, malignancy or neurologic deficit limiting follow-up or adherence to the study protocol.
* Participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days prior to randomization
* Inability to give at least verbal informed consent to the study.
* Contraindications to the use of clopidogrel or prasugrel as per package leaflet.
Combining Resting Blood Flow Restriction with Neuromuscular Electrical Stimulation: Effects on Blood Lactate Levels and Lower Limb Muscle Function

The current research landscape shows studies indicating increased muscle strength and hypertrophy through neuromuscular electrical stimulation combined with blood flow restriction. However, there is a lack of research specifically on the effects of this combination during rest periods. Therefore, the primary objective of this study is to investigate the impact of resting blood flow restriction training combined with neuromuscular electrical stimulation on blood lactate levels and changes in lower limb muscle function in healthy male adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males in their 20s,
* Individuals who answered less than one item on the PAR-Q (Physical Activity Readiness Questionnaire),
* Participants who consented to the use and publication of their physical function evaluation data and expressed a desire to participate in the exercise experiment.

Exclusion Criteria:

* Individuals with severe hypertension (blood pressure above 170/110 mmHg),
* Individuals with a history of deep venous thrombosis,
* Individuals with endothelial dysfunction,
* Individuals with peripheral vascular disease,
* Individuals with one or more of the following conditions: diabetes, infection, cancer,
* Participants who expressed a desire to withdraw during the study period or whose participation rate was below 80% were excluded from the study.