cyrilzakka/clinical-trials huggingface dataset:
Hyperemic Efficacy of IV Adenosine in HFrEF

Little is known about the hyperemic efficacy of IV adenosine as well as safety in patients with heart failure with reduced ejection fraction (HFrEF) because they were excluded from the major FFR studies. We will evaluate the feasibility and hyperemic efficacy of IV adenosine in patients with HFrEF in comparison with IC nicorandil for invasive physiological assessment using a coronary pressure wire.

Little is known about the hyperemic efficacy of IV adenosine as well as safety in patients with heart failure with reduced ejection fraction (HFrEF) because they were excluded from the major FFR studies. We will evaluate the feasibility and hyperemic efficacy of IV adenosine in patients with HFrEF in comparison with IC nicorandil for invasive physiological assessment using a coronary pressure wire. Patients with an angiographically intermediate lesion (40-70% diameter stenosis) in a major epicardial coronary artery and with left ventricle ejection fraction ≤40% will be prospectively enrolled. FFR under the various hyperemic stimulation using IV adenosine 140 \& 180, IC adenosine, and IC nicorandil will be measured sequentially.

Eligibility Criteria:
Inclusion Criteria:

* angiographically proven epicardial intermediate stenosis (40-70%)
* echocardiographically proven LV dysfunction (LVEF ≤40%)

Exclusion Criteria:

* infarct-related artery, less than 2 weeks
* Killip class 3 and 4
* bronchial asthma
* second degree or third degree AV block
* any contraindications to adenosine
Selective Lymph Node Dissection for cT1N0M0 Invasive NSCLC With CTR>0.5 Located in the Apical Segment (ECTOP-1018)

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1018. The goal of this clinical trial is to confirm the theraputic effect of selective lymph node dissection for cT1N0M0 invasive non-small cell lung cancer with CTR\>0.5 located in the apical segment. The main questions it aims to answer are:

The 5-year overall survival of patients having cT1N0M0 invasive non-small cell lung cancer with CTR\>0.5 located in the apical segment; The post-operative lymph node metastasis and recurrence-free survival. Participants will receive selective lymph node dissection as the surgical procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who sign the informed consent form and are willing to complete the study according to the plan;
2. Aged from 18 to 80 years old;
3. ECOG equals 0 or 1;
4. Not receiving lung cancer surgery before;
5. Resectable peripheral cT1N0M0 tumors with CTR\>0.5 located in the apical segment;
6. Non-lepidic predominant invasive NSCLC dignosed by frozen section;
7. Not receiving chemotherapy or radiotherapy before.

Exclusion Criteria:

1. Not cT1N0M0;
2. Nodules not located in the apical segment or CTR≤0.5;
3. Pre-invasive lung adenocarcinoma, lepidic predominant adenocarcinoma, or not lung adenocarcinoma diagnosed cytologically or pathologically;
4. Receiving lung cancer surgery before;
5. Receiving radiotherapy or chemotherapy.
Cloud Based Follow up of CPAP Treatment

Obstructive sleep apnea (OSA) is treated with a continuous positive airway pressure, so called CPAP. A new technology that enables telemetric monitoring of CPAP therapy. This study randomizes 560 patients to A) conventional follow up procedures or B to a telemedicine based follow up procedure. Main endpoint parameter is CPAP treatment compliance at 3 months after start of treatment.

Background:

Obstructive sleep apnea (OSA) is treated with a continuous positive airway pressure, so called CPAP, during sleep. CPAP startup and follow-up is performed at four sleep clinics in the West Swedish Region (SU / S, SÄS, SkaS, NÄL). Patient volumes are high, waiting times are long and long-term follow-up is inconsistent. A new technology that enables telemetric monitoring of CPAP therapy based on transfer of therapy data to a data cloud has been introduced. Healthcare personnel can identify patients with therapy problems.

Data from minor studies suggest several benefits of this telemedicine solution (increased therapeutic capacity, lower patient and community costs and a time benefit for the sleep medicine unit). Today, the sleep Clinical in the region use different procedures for monitoring CPAP treatment.

Scientific question:

Is telemedicine monitoring of CPAP treatment an adequate solution for follow up in all patients ? Is the additional cost of a telemedicine solution balanced by a better outcome after therapy?

Hypothesis:

Intensive telemedicine monitoring, especially at the start of CPAP therapy, leads to improved CPAP care at the participating sleep units.

Method:

The study randomizes 560 patients (moderate to severe sleep apnea) to different CPAP treatment follow up procedures: A) the current routine of the sleep clinic or B) the new telemedicine solution (1: 1 randomization). The main outcome parameter of the study is the mean CPAP use after 3 months of treatment. Secondary outcome parameters include the reduction of sleep apnea intensity, daytime sleepiness, and patient-related outcome measures (PROM).

Aim:

The aim of the study is to map the pros and cons of a telemedicine solution in CPAP therapy regarding treatment outcomes, patient quality of life and resource utilization at the sleep center.

Eligibility Criteria:
Inclusion Criteria:

* Verified sleep apnea diagnosis according to ICSD II criteria
* Indication for CPAP treatment according to Swedish national guidelines
* Capacity to read and understand the Swedish language
* Willingness to test CPAP treatment

Exclusion Criteria:

* Instable concomitant disease requiring frequent hospitalization
* Alcohol and drug abuse
* Non-availability during the follow up during 3 months (e.g. frequent or long-term travelling)
* Hypoventilation syndrome with PCO2\>7kpa
Platelet Rich Plasma for Insufficient Endometrium

To determine the effectiveness of an intrauterine PRP infusion on endometrial thickness and in vitro fertilization (IVF) outcomes in a population of infertile women with a history of unresponsive thin endometrium.

Patients with a history of thin endometrium will be randomized to either an intrauterine infusion of PRP vs. a placebo infusion of normal saline. This is a double-blind, placebo controlled prospective RCT. Patients will then proceed with a frozen embryo transfer of a single euploid embryo per routine.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have previously undergone at least 2 unsuccessful frozen embryo transfer cycles, defined as failure to achieve a sustained clinical pregnancy (visualization of intrauterine gestational sac on ultrasound or a cancelled embryo transfer cycle due to inadequate endometrial thickness
* Patients with a diagnosis of thin endometrial lining (less than or equal to 6 mm maximum thickness) during prior unsuccessful or canceled embryo transfer cycles.

Exclusion Criteria:

* Fewer than 2 prior unsuccessful or canceled frozen embryo transfer cycles.
* Most recent unsuccessful embryo transfer prior to January 1, 2017.
* Mullerian anomalies, excluding arcuate uterus
* Concurrent submucosal fibroids, unrepaired uterine defects or present indication for uterine surgery
* Communicating hydrosalpinx without plans for surgical correction prior to study enrollment.
* Failure of patient to agree to enrollment in study with written consent.
* Concurrent pregnancy
* Anticoagulation use for which plasma infusion is contraindicated
* History of thrombosis
* Thrombophilia either inherited or acquired
* Concomitant use of adjunctive therapies for proliferation. These must be discontinued upon enrollment.
* Embryo planned to be used for transfer generated from surgically obtained sperm due to a diagnosis of non-obstructive azoospermia
* Recurrent/persistent endometrial fluid in prior cycles
The Effect of Pilates Group Exercise Program

INTRODUCTION AND AIM: The Pilates exercises were introduced by Joseph Pilates in the 1920s, originally called 'centering'. These exercises work on 6 simple principles with or without special equipment. These principles are; centering, concentration, tenderness, flow and respiration. (Yamato et al., 2016) Functional movement analysis is a screening system developed by physiotherapist Gray Cook. Functional deficits of the person are detected by 7 different movements (Cook, Burton and Hoogenboom 2006a, Cook, Burton and Hoogenboom 2006b). In a single study they compared in the literature that assessed the effect of Pilates exercises on functional movement, this activity was explored on recreational runners (Laws, Williams and Wilson 2017). The aim of this study was to investigate the effect of 12-week pilates group exercise training on functional movement scores in sedentary women. Secondarily; posture, depression level and quality of life will be evaluated.

MATERIAL-METHODS: This study has been reviewed by Ethics Committee of Non-Interventional Researches of the University of Medipol in Istanbul and its ethical conformity has been approved. (10840098-604.01.01-E.45484). Participants were informed of the voluntary consent form and signed the consent form.

Participants 20 sedentary women were included in the study between 30-50 years of age.

Evaluations

Demographic information (Age, Occupation, Height, Weight) of the persons will be recorded.Functional Movement Analysis; Postural Analysis, Depression level; Health Related Life quality will be recorded.

Application Pilates exercises will be applied by a qualified physiotherapist with an internationally recognized certificate on the subject. Participants will be asked to come up with suitable outfits. the exercise room will be set at the ideal temperature and well ventilated. The exercises to be done in the form of group exercises will be started with an entry level, and the level of the exercises will be increased appropriately in the following weeks. Each group will consist of no more than 10 people and the exercises will continue for three sessions per week for 12 weeks. The evaluations will be repeated before exercise, at the end of 12 weeks of exercise and after 3 months from finish of the exercise period.


Eligibility Criteria:
Inclusion Criteria:

* Have not had a surgical operation involving the musculoskeletal system in the past six months.
* Not to have a systemic disease leading preventing from exercise.
* Not having had any exercise in the last 3 months.

Exclusion Criteria:

* Do not want to continue exercises.
* To feel pain, discomfort during tests.
Use of 1 Minute Sit to Stand Test for Physical Capacity and Effort Related Desaturation in Amyotrophic Lateral Sclerosis

The aim of this study is to investigate the usability of the 1 Minute Sit to Stand Test (1 MSTS) in evaluating physical capacity and effort-related desaturation in individuals with Amyotrophic Lateral Sclerosis (ALS). In this context, patients diagnosed with ALS who meet the inclusion criteria will be included in the study. For the physical capacity assessment of patients with ALS at different ambulatory levels included in this study, a 6 minutes walking test (6 MWT) and a 1 MSTS will be applied. Before and at the end of the test, the severity of dyspnea and leg fatigue of the patients will be determined by the Modified Borg Scale; effort-induced desaturation and heart rate by fingertip pulse oximetry; peripheral muscle strength (for the quadriceps femoris muscle) will be evaluated with a hand held dynamometer. When the studies are examined, it has been determined that the 6 MWT is relatively difficult to tolerate in individuals with ALS, it may be difficult to provide the necessary space and equipment for the test, and a shorter, easy-to-apply, and practical evaluation method that can be used instead of this test in the clinic is needed. As a result of this study, the usability of the 1 MSTS in individuals with ambulatory ALS in evaluating physical capacity and desaturation due to effort will be revealed.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ALS
* 18 years and over
* Ambulatory
* Volunteer to participate in the study

Exclusion Criteria:

* Having a comorbidity that may affect the results of the study (orthopedic, cardiopulmonary, orthopedic, psychiatric, etc.)
* Not willing to participate in the study
Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients .

Increase in the prevalence and survival rates has led to the assessment of disease activity and quality of life of SLE patients as targets in treatment. Cholecalciferol supplementation was considered as having a role in reducing disease activity and improving quality of life.This research was a double blind, randomized, controlled trial was conducted on female outpatients aged 18-60 years with SLE, consecutively recruited from September to December 2021 at Cipto Mangunkusumo Hospital. Sixty subjects who met the research criteria were randomized and equally assigned into the cholecalciferol and placebo groups. The study outcomes were measured at baseline and after 12 weeks of intervention. we measured he level of vitamin D before and after intervention, the disease activity by MEX-SLEDAI score and the quality of life by Lupus QoL


Eligibility Criteria:
Inclusion Criteria:

* Women subjects aged 18-60 years old with hypovitaminosis D

Exclusion Criteria:

* declining consent to participate, late stage chronic kidney disease (staged 4-5), decompensated liver cirrhosis, consumption of glucocorticoids (equivalent to prednisone 20 mg/day) in the past 30 days, pregnant or lactating, patients with acute infection, hypercalcemic patients, anticonvulsant consumption.
High-Intensity Interval Training on Pre-Hypertensive Subjects

Despite exercise training decrease blood pressure in 'average' terms, there is a wide interindividual variability after exercise training, being yet unknown what mode of exercise (e.g. endurance, strength, concurrent, or high intensity interval training) produce more/less non-responder (NR) prevalence (i.e., percentage of subjects who experienced a non-change/worsened response after training in some outcome).

Despite exercise training decrease blood pressure in 'average' terms, there is a wide interindividual variability after exercise training, being yet unknown what mode of exercise (e.g. endurance, strength, concurrent, or high intensity interval training) produce more/less non-responder (NR) prevalence (i.e., percentage of subjects who experienced a non-change/worsened response after training in some outcome).

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent;
* Interested in improving health and fitness;
* Systolic blood pressure \> 120 mmHg and \< 140 mmHg, and/or DBP ≥ 80 and \< 90 mmHg according with standard classification;
* No drug therapy during the previous 3 months;
* Body mass index (BMI) 25 and 35 kg/m2); (c) physically inactive (according to the International Physical Activity Questionnaire previously validated in Chilean population)
* Normal /mild altered lipid profile (total cholesterol \[TC\] \~200 and ≤250 mg/dL, low-density lipids \[LDL-C\] \~140 mg/dL and ≤200 mg/dL, high-density lipids \[HDL-C\] ≥20 and \~40 mg/dL, triglycerides \~150 and ≤250 mg/dL) according with standard classification.

Exclusion Criteria:

* Cardiovascular contraindications to exercise histories of stroke;
* Asthma and chronic obstructive pulmonary disease;
* Musculoskeletal disorder such as low back pain;
* Smokers in the last 3 months were not included in the study.
The Effects of Logotherapy Based Psychosocial Support Program on Nursing Students on the Meaning of Life and Life Satisfaction

This study is a psychosocial intervention program designed to intervene in the meaning of life and existential problems and life satisfaction in nursing students, especially during the epidemic. In the short term, it expects that students will gain awareness, especially in areas such as life satisfaction, anxiety, aimlessness, the meaning of life, deterioration in functionality, and in the long term, the individual's ultimate issues (death, loneliness, meaning and responsibility) and provide a perspective that can cope with the problems that may arise in these areas. Based on all these, it is aimed to raise awareness of the meaning of life and life satisfaction in nursing students, who constitute a young population, with the existential approach and logotherapy-based psychosocial support program.

H1. The existential approach and logotherapy-based psychosocial support program will affect the experimental group's meaning and purpose of life scale scores.

H2. The existential approach and logotherapy-based psychosocial support program will affect the experimental group's life satisfaction scale scores.

H3. After the existential approach and logotherapy-based psychosocial support program, there will be a significant difference between the experimental and control groups' meaning and purpose of life scores.

H4. After the existential approach and logotherapy-based psychosocial support program, there will be a significant difference between the experimental and control groups' life satisfaction scores.


Eligibility Criteria:
Inclusion Criteria:

* Completed mental health and psychiatric nursing course
* Agreeing to participate as a result of the research announcement
* No acute psychiatric problem
* Those who have not lost their first-degree relative due to Covid-19

Exclusion Criteria:

* Having an acute psychiatric problem
* Those who lost their first-degree relative due to Covid-19
Evaluation of Effect of Combination With Telmisartan and Hydrochlorothiazide in Hypertensives Uncontrolled on Amlodipine

The purpose of this study is to compare depressor effect and safety between combination therapy with telmisartan plus low-dose hydrochlorothiazide and amlodipine in hypertensive patients.

In hypertensive patients whose blood pressure (BP) does not reach less than 140/90 mmHg with 5mg/day of amlodipine are divided the following two groups and BP response, laboratory data, and adverse effects are compared. Group 1: 12 week combination therapy with telmisartan plus low-dose hydrochlorothiazide. Group 2: Amlodipine is continuously administered.

Eligibility Criteria:
Inclusion Criteria:

* 5 mg/day of amlodipine is administered for more than 3 months
* Systolic or diastolic blood pressure \>= 140/90 mmHg (more than 2 times measurements at outpatient clinic before start of the study)
* Outpatients

Exclusion Criteria:

* Secondary hypertension including renovascular hypertension with single kidney or bilateral stenosis
* Administration of antihypertensives other than amlodipine
* Cardiovascular disease (cerebral hemorrhage, cerebral infarction, TIA, angina, myocardial infarction, acute renal failure) occurs less than 6 months before start of the study
* Serum creatinine \>= 2.0 mg/dl
* Severe hypertension (systolic or diastolic blood pressure \>= 180/110 mmHg) or malignant hypertension (hypertensive organ damage is rapidly developing)
* Chronic heart failure (NYHA class\>=III to VI)
* Contraindication of telmisartan or hydrochlorothiazide
* Hyper- (\>= 5.5 mEq/L) or hypo- (\<=3.5 mEq/l) potassemia
* Untreated hyperuricemia or uncontrolled hyperuricemia (serum uric acid \>= 8.0 mg/dl)
* Diabetic patients who require insulin therapy, uncontrolled diabetic patients (hemoglobin A1c \>=9.0%), or patients who possess the risk of hypoglycemic attack
* Patients inadequate for the study
Pain Management for Cystoscopy: A Prospective Randomized Study Focused on Understanding the Role of the "Bag Squeeze" to Manage Pain for Patients Undergoing Cystoscopy

The purpose of this study is to determine whether utilization of the "bag squeeze" technique during flexible cystoscopy changes pain scores using a study questionnaire designed by the team which comprises a validated Lingard pain rating scale.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Undergoing flexible cystocopy at University Health Network that have undergone a flexible cystocopy and did not demonstrate difficulty during exploration (meatal stenosis or urethral stricture), simultaneous removal or ureteral stents or bladder biopsies or have a chronic history of pelvic pain

Exclusion Criteria:

- Patients that do not meet the inclusion criteria.
Effects of Spironolactone on Collagen Metabolism in Patients With Pulmonary Arterial Hypertension

The purpose of this study is to determine the effects of spironolactone on collagen markers in a large number of patients with pulmonary hypertension. In addition, safety and tolerability of spironolactone, an aldosterone receptor antagonist, in patients with pulmonary arterial hypertension, will be determined.

Pulmonary arterial hypertension (PAH) is an orphan disease characterized by pulmonary artery hypertrophy, and resulting vascular remodeling of involved vessels, often leading to right heart failure. Accumulating evidence from vascular biology, animal models, and therapeutic drug trials suggests significant contributions of the neurohormonal milieu to the disease process, morbidity, and mortality. The renin-angiotensin-aldosterone system (RAAS) is an important neurohormonal pathway that induces collagen synthesis in the myocardium and systemic vasculature. There is paucity of data regarding the contribution of RAAS in the pathogenesis of PAH and the effects of aldosterone blockade in the amelioration of PAH. Thus, the overall goal of this proposal is to investigate the contribution of RAAS to the pathogenesis of PAH, and to explore the effects of an aldosterone blocker, spironolactone, in PAH.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Body weight \> 40 kg
* PAH Diagnostic Group I
* Stable subjects with no change in PAH specific therapy within the last 4 weeks
* No change in dose of background therapy (digoxin, diuretic) within the last 2 weeks excluding anticoagulation

Exclusion Criteria:

* Unable to give informed consent
* Hemodynamically unstable subjects
* Pregnant or breast feeding
* Have significant renal insufficiency (serum creatinine \>2.5 mg per deciliter or required hemodialysis)
* Have significant liver dysfunction (AST or ALT more than three times upper limit of normal)
* Currently on aldosterone receptor blocker (spironolactone or eplerenone) or ACE inhibitor
* PH due to left heart disease
* Unable or unwilling to comply with study procedures
A Clinical Trial of Retinal Gene Therapy for X-linked Retinitis Pigmentosa Using BIIB112

The objective of the study is to evaluate the safety, tolerability and efficacy of a single sub-retinal injection of BIIB112 in participants with X-linked retinitis pigmentosa (XLRP).

This study was previously posted by NightstaRx Ltd. In October 2020, sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Key Inclusion Criteria:

Part 1:

* Participants with genetically confirmed diagnosis of XLRP (with RPGR mutation).
* Participant with active disease clinically visible within the macular region in both eyes.

Part 2:

- Participant with mean total retinal sensitivity in the study eye as assessed by microperimetry ≥ 0.1 dB and ≤8 dB.

Key exclusion Criteria:

Parts 1 and 2:

* Participant with history of amblyopia in either eye.
* Participated in a gene therapy trial previously or a clinical trial with an investigational drug in the past 12 weeks or received a gene/cell-based therapy at any time previously.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.