cyrilzakka/clinical-trials huggingface dataset:
High-resolution Oximetry to Diagnose Obstructive Sleep Apnea

The aim of this study was to compare an overnight digital monitoring device (ODM) with home sleep apnea testing (HSAT) using respiratory flow and effort parameters in a large population sample, who were in a waiting list for Polysomnography (PSG).

Obstructive Sleep Apnea (OSA) is extremely common has prompted the popularization of home sleep test (HST). HST record a limited number of respiratory signals, provide a more comfortable testing option to the patient at a lower cost. HST has a performance as good as PSG among patients with suspected OSA and no significant co-morbidities.

Our study was designed to investigate the performance of a simple solution that consists of a high-resolution wireless oximeter with a built-in accelerometer linked to a smartphone application and automated cloud algorithm for detection of oxygen desaturation, described herein as Overnight Digital Monitoring (ODM) (BilogixTM). We will compare the results of ODM with HST performed by ApneaLink Air by Resmed®.

We have already compared ODM to PSG with excellent results in a prior study and intend to see the results in uncontrolled environment (home) .

Population: Men and women from the São Paulo Department of Health, who are awaiting examination for diagnosis of OSAS.We intend to compare the ODM with the HST. Patients with indication for CPAP titration will be excluded. The participants will wear a wireless oximeter (Oxistar, Biologix Sistemas Ltda., Brazil) with a built-in accelerometer on a finger of the same hand as the HST oximeter and we will compare both methods for diagnosing OSA.

All HST studies will be scored by 2 independent certified technicians blinded to the ODM results. Hypopnea will be defined as a peak signal excursion drop by ≥ 30% of pre-event baseline nasal pressure signal lasting ≥ 10 sec. Hypopneas will be scored according the acceptable AASM criteria for hypopnea (≥ 4% reduction in SpO2). Mild, moderate and severe OSA will be defined according to the current standards (5 ≤ AHI \<15; 15 ≤ AHI \<30 and AHI ≥30 events/h, respectively).ODI results from ODM will be expressed as the number of desaturations per recording time and will be automatically analyzed at the cloud. In order to compare with TST-AHI4%, ODM will be matched using 4% desaturation criteria (ODM-ODI4%, respectively).

Eligibility Criteria:
Inclusion Criteria:

* Adult ambulatory patients who are in a waiting list for polysomnography that are able to properly place the oximeter and home sleep test at home

Exclusion Criteria:

* patients under treatment for OSA
Investigation of The Effectiveness of Antioxidant Therapy in Oligoasthenoteratozoospermic Infertile Men

Approximately 30% of the factors that cause male infertility are due to idiopathic causes. Increased reactive oxygen species (ROS) due to many known and unknown factors cause male infertility by affecting spermatogenesis and sperm maturation. In this study, the effects of physical activity and antioxidant food supplementation on seminal antioxidant capacity, sperm DNA fragmentation index, sperm chromatin quality and sperm parameters were investigated in infertile cases.

Material and Method: The study included subfertile men with idiopathic oligoasthenoteratozospermia seen at Ondokuz Mayıs University Faculty of Medicine between March 2021 and November 2021.

All subjects were recommended to do moderate physical activity for at least 45 minutes (at least 150 minutes-600 METs per week) 3-4 days a week for three months. A total of 48 cases were divided into two groups by computer-assisted (www.randomizer.org) complete (simple) randomization. In the first group (Group 1), 2000 mg L-carnitine, 2000 mg fructose, 932 mg acetyl L-carnitine, 225 mg vitamin C, 115 mg citric acid, 50 mg coenzyme Q10, 14 mg zinc, 115 µg selenium, 3750 µg Food supplement containing vitamin B12 and 500 µg folic acid was recommended as one sachet in the morning and evening, while antioxidant food supplement was not given to the second group (group 2). Before and after treatment, semen parameters, Hormone analyzes with ELISA method, physical activity evaluation with IPAQ questionnaire, seminal antioxidant capacity with Trolox equivalent antioxidant capacity (TEAC) measurement method, DNA fragmentation index with TUNEL method. and sperm chromatin structure was evaluated by aniline blue staining.

Student's t test was used for the variables showing normal distribution in independent groups, and Mann Whitney U test was used for the variables that did not fit the normal distribution. Paired t test was used for the variables showing normal distribution in the dependent groups, and Wilcoxon test was used for the variables that were found not to fit the normal distribution.

Eligibility Criteria:
Inclusion Criteria:

1) Clinical diagnosis of idiopathic oligoasthenoteratozoospermia

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Exclusion Criteria:

1. Vasectomy
2. Azoospermia or severe oligozoospermia
3. Current use of a treatment or drug
4. Cancer, heart disease or cirrhosis history
5. Uncontrolled diabetes mellitus -
rTMS Effects on Smoking Cessation and Cognition in Schizophrenia

Patients with schizophrenia have high rates of cigarette smoking and tobacco dependence, and great difficulties in quitting smoking. The development of novel and more effective treatments for tobacco dependence in this population is thus needed. This study will test the hypothesis that repetitive transcranial magnetic stimulation (rTMS) may facilitate smoking cessation with the transdermal nicotine patch (TNP) in patients with schizophrenia motivated to quit smoking. A total of N=40 smokers with schizophrenia would be assigned to either active rTMS (N=20) or sham rTMS (N=20) as a treatment regimen of 5X/week treatments for four weeks. All subjects would receive TNP (21 mg/24h) and weekly group behavioral therapy for smoking cessation for a total of 10 weeks. The investigators predict that active rTMS will be well-tolerated and superior to sham rTMS for enhancing smoking cessation rates in smokers with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia or schizoaffective disorder
* Smoking at least 10 cigarettes per day and a Fagerstrom score of at least 4.
* Willing to quit smoking in the next 30 days.

Exclusion Criteria:

* Active alcohol or illicit drug abuse or dependence in the past 3 months
* A history of seizures, head trauma or space occupying lesions.
* A history of alcohol or illicit drug abuse in the past 6 months.
* Intolerance of the nicotine patch or its excipients
* Evidence for psychiatric instability as judged by acute psychotic exacerbations, suicidal or homicidal ideation.
* Females who are pregnant.
The Effect of Mandala Coloring on Anxiety and Mental Fatigue in Pregnant Women Diagnosed With Threatened Preterm Labor

The research will be conducted in a pre-test-post-test control group randomized control design. The aim is to examine the effect of mandala work on anxiety and mental fatigue in pregnant women diagnosed with threatened preterm labor. Hypotheses

1. Mandala coloring work reduces the level of anxiety related to pregnancy in pregnant women diagnosed with threatened preterm labor.
2. Mandala coloring work reduces the level of anxiety in pregnant women diagnosed with threatened preterm labor.
3. Mandala coloring work reduces the level of mental fatigue in pregnant women diagnosed with threatened preterm labor.

Pregnant women who meet the inclusion criteria will be given general information about the research before randomization, their consent will be obtained and pre-test data will be collected. Pregnant women whose pre-test data are collected will be assigned to the intervention and control groups using the simple randomization method.

Intervention group: Participants in the intervention group will be given a set of colored markers and a mandala coloring page and will be asked to color them at any time of the day and in any way they want during their hospitalization. Participants will be asked to take a picture of the mandala they colored and send it to the researcher after they are finished. Participants will be reminded daily so that they do not forget to do the activity. Research data will be collected a total of four times before randomization, on the 1st day, 2nd day and 3rd day after the mandala application was started.

Control Group: No intervention other than routine care will be made to the control group of the study, and research data will be collected at simultaneous time intervals with the experimental group.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who can read and write Turkish,
* Diagnosed with threatened preterm labor,
* Are between 32-36 weeks of gestation,
* Primiparous,
* Hospitalized,
* Open to communication (able to understand and answer questions) will be included in the sample.

Exclusion Criteria:

* Pregnant women with a history of miscarriage or stillbirth,
* Those who voluntarily withdrew from the study,
* Those with a history of psychiatric illness (self-report),
* Those who do not have a physical disability that would prevent them from coloring mandalas will be excluded from the study.
Safety Study of CTS21166 to Treat Alzheimer Disease

This study is the first human exposure for the drug candidate CTS21166 in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male \> age 21;
* non-smoker (minimum 6 months);

Exclusion Criteria:

* History or evidence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,neurologic, psychiatric, oncologic, or allergic (including anaphylactic drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease
* History or evidence of intravenous illicit drug use, human immunodeficiency virus (HIV), hepatitis B, or hepatitis C;
* Participation in another clinical trial within 30 days prior to dosing
The Efficacy of Nasal High Flow Oxygen Therapy With Rehabilitation in the Patients With Chronic Respiratory Failure

The purpose of this study is to compare the exercise endurance between oxygen therapy with rehabilitation and nasal high flow therapy with rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.

In patients with chronic respiratory failure, pulmonary rehabilitation is recognized as an evidence-based treatment in improving exercise capacity, muscle strength, dyspnea, and quality of life. Oxygen supplementation during exercise induced dose-dependent improvement in endurance and symptom perception in chronic obstructive pulmonary disease patients. Recently, nasal high flow therapy which consists of high flow gas with an FiO2 ranging from 0.21 to nearly 1.0 adjusted by an oxygen blender, brought to body temperature, and saturated with water through an in-line humidifier is available.

The present study is randomised to compare the effect of exercise endurance between oxygen therapy with rehabilitation and nasal high flow therapy with rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with chronic respiratory failure receiving long-term oxygen therapy for more than 3 months.

Exclusion Criteria:

* Subjects with severe cardiovascular disease, diabetes, neurological disease, and renal failure.
* Subject who are unable to undergo rehabilitation.
Study to Evaluate the Effect of Megestrol Acetate in Weight Loss in Dementia Patients

The purpose of this study is to demonstrate the efficacy of megestrol acetate in the gain of body weight in patients with primary or mixed Dementia with a weight loss.

In all geriatric patients with dementia it was prove a weight loss independently if they are institutionalized or not.There are some previous studies that indicates the effect of the megestrol acetate in the weight gain of patients with cachexia-anorexia related with neoplasia. It seems that the mechanism of development could be the same between these patients and patients with dementia. It was described an important role of a group of cytokines ( Il-6, leptin, neuropeptide Y, TNFalfa) in the development of this nutritional alteration.

Some previous pilots studies indicates that megestrol acetate has and effect in geriatric and dementia patients with a weight loss of at least 5% in the last 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed of primary or mixed dementia (CIE 10criteria)
* Weihgt loss \>5% of habitual weight in the last 6 months and proteic-caloric malnutrition (MNA \<17)
* Outpatients
* Patients that accept the participation in the study

Exclusion Criteria:

* Vascular pure Dementia and secondary dementias( vascular dementia, Parkinson disease,etc)
* Dementia in a terminal phase: category of FAST 7c in the Reisber scale
* Concomitant treatment with steroids, androgens or other drugs with progestagens
* Weight loss secondary to neoplasia
Study on Clostridium Difficile Infection in Infants

This study aims to investigate the epidemiological characteristics and biomarkers of Clostridium difficile infection in infants . By analyzing historical medical data and patient questionnaires, this retrospective cohort study will identify potential high-risk factors and establish baseline biomarkers to improve diagnosis and treatment for affected patients.

This retrospective cohort study focuses on Clostridium difficile infection (CDI) in infants n, a relatively rare infection. The study will utilize data from hospital and community to identify the prevalence, risk factors, and unique biomarkers associated with CDI in pediatric patients. Key objectives include: (1) analyzing demographic and clinical characteristics of affected patients, (2) evaluating the high-risk factors of CDI, and (3) identifying biomarkers that can aid in early detection and treatment planning. Findings from this study are expected to contribute to the improvement of CDI management in pediatric care.

Eligibility Criteria:
Inclusion Criteria:

* Infants ( aged 0-2 years). Medical records and patient questionnaires available with confirmed Clostridium difficile infection (for case group) or without infection (for control group).

Exclusion Criteria:

* Infants beyond the age of 2 years at the time of diagnosis. Incomplete medical records or missing essential information related to infection status, feeding methods, or antibiotic exposure.Patients with other severe gastrointestinal conditions that may confound results.
Effect of Whey Protein on Soccer Performance

Rationale: During exercise protein breakdown in muscles is larger than protein synthesis. This negative muscle protein balance leads to increased muscle damage and thereby to a reduced muscle tissue recovery. To achieve a positive muscle protein balance and reduce muscle damage, many athletes use proteins. In professional soccer players, considerable stress is placed on the musculoskeletal system. Recovery time is often too short for these players to restore homeostasis, which results in catabolic processes. This increases playing errors and will lead to lapses in concentration. Therefore, it is of great importance for a professional soccer team to be in optimal condition and a fast recovery after exercise is desirable to accomplish maximum performance. Supplementation with whey proteins is thought to support this.

Objective: To assess whether post-exercise supplementation with whey protein will lead to a better muscle recovery than supplementation with carbohydrates in Dutch soccer players between the age of 15 and 18 years old.

Study design: A double blind randomised controlled cross-over trial.

Study population: Healthy soccer players of the A and B selection of AJAX between the age of 15 and 18 years old.

Intervention: Supplement, containing either whey proteins or an isocaloric carbohydrate placebo. Each supplement will be administered for 2 weeks separated by a 7 day washout period. Treatment order will be randomly assigned.

Main study parameters: The main study parameter will be the Yo-Yo intermittent recovery test level 2 score and the vertical jump test. The scores will evaluate the soccer players' ability to repeatedly perform intense exercise and his potential to recover from this exercise.


Eligibility Criteria:
Inclusion Criteria:

* performing soccer \>1 year
* part of A \& B selection of AJAX

Exclusion Criteria:

* presence of lactose intolerance
* presence of illness
* presence of injury
Adaptive vs. Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease

The objective of the CLOSE-PD study is to compare the efficacy of adaptive deep brain stimulation (aDBS) with continue deep brain stimulation (cDBS) in patients with Parkinson's disease. The main question it aims to answer is:

- whether the change in daily mean ON time without troublesome dyskinesia in aDBS is greater than cDBS over a six-month follow-up period?

Researchers will compare aDBS to regular continue deep brain stimulation (cDBS).

Participants will:

* be randomized 1:1 to aDBS or cDBS;
* follow-up will be six months;
* complete PD Home diary at baseline, two months, four months and at six months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic PD based on the UK Brain Bank criteria (Hughes et al. 1992);
* Age older than 18 years;
* Previous implantation of Medtronic PerceptTM PC/RC DBS electrodes bilateral targeting the STN;
* Reliable beta peak in at least one STN;
* Able to provide informed consent and comply with the study protocol;
* Understand the Dutch language.

Exclusion Criteria:

* Legally incompetent adults;
* Patients with ongoing participation in other clinical trials involving neurological interventions;
* Inability to recognize the difference between the motor ON or OFF state;
* Mild cognitive impairment or dementia;
* Pregnancy.
Developing and Piloting an Online, Self-help Intervention (STAGE) for Anxiety

This study pilots a novel, brief, online, self-help training course for anxiety management, aimed at adults experiencing moderate to moderately-severe anxiety.

This study is a pilot randomised controlled trial (RCT) comparing a brief, online self-help, anxiety management training course ('STAGE') with a wait-list control. A battery of self-report measures will be administered online at baseline (week 0), post-intervention (week 3) and at follow-up (week 5).

Eligibility Criteria:
Inclusion Criteria:

* having a score, at baseline, on the Generalised Anxiety Disorder 7 (GAD-7) scale of between 8 and 15, inclusive;
* having regular internet access;
* being based in the UK.

Exclusion Criteria:

* significant risk issues in the last year;
* currently receiving another psychological intervention, whether it be self-help or face-to-face;
* having recently (within the last six months) completed a psychological intervention.
Entospletinib in Combination With Idelalisib in Adults With Relapsed or Refractory Hematologic Malignancies

This study will evaluate the efficacy of the combination entospletinib and idelalisib in participants with relapsed or refractory hematologic malignancies. Participants will be enrolled who have one of the following hematological tumor types: chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), or indolent non-Hodgkin lymphomas (iNHL; including follicular lymphoma (FL) and lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia \[LPL/WM\], small lymphocytic lymphoma \[SLL\], or marginal zone lymphoma \[MZL\]).


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of B-cell indolent non-Hodgkin lymphoma (iNHL),diffuse large B-cell lymphoma (DLBCL),mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) as documented by medical records and with histology based on criteria established by the World Health Organization
* For institutions that have Phase 3 or Phase 4 protocols studying idelalisib (Zydelig®; GS-1101); individuals with malignancies being studied in these protocols must have failed screening and be registered as a screen failure in the respective idelalisib protocol
* Prior treatment for lymphoid malignancy
* Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy
* Discontinuation of all therapy for the treatment of cancer ≥ 3 weeks before the start of study drug
* All acute toxic effects of any prior antitumor therapy resolved to Grade ≤ 1 before the start of study drug
* Karnofsky performance status of ≥ 60
* Life expectancy of at least 3 months

Key Exclusion Criteria:

* Known histological transformation from iNHL or CLL to an aggressive form of NHL (ie, Richter transformation)
* Known active central nervous system or leptomeningeal lymphoma
* Presence of known intermediate- or high-grade myelodysplastic syndrome
* Current therapy with agents that reduce gastric acidity, including but not limited to antacids, H2 inhibitors, and proton pump inhibitors
* Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of start of study drug
* Ongoing liver injury
* Ongoing or recent hepatic encephalopathy
* Ongoing drug-induced pneumonitis
* Ongoing inflammatory bowel disease
* Ongoing alcohol or drug addiction
* Pregnancy or breastfeeding
* History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
* Ongoing immunosuppressive therapy
* Concurrent participation in an investigational drug trial with therapeutic intent

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation (ACHIEVE)

The ACHIEVE study is a single-arm, open-label, prospective, post-market follow-up study to include up to one hundred (100) eligible patients as defined within the clinical investigational plan, with a twelve month follow-up period. The ACHIEVE study was originally designed in accordance with the 2007 ESH ESC guidelines for resistant hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Resistant hypertension, as defined in the 2007 ESH-ESC guidelines
* 18 years of age or older
* Negative pregnancy test for female patients of childbearing potential
* Willing and able to comply with follow-up requirements
* Signed informed consent

Exclusion Criteria:

* Secondary hypertension
* Main renal arteries length \< 20 mm
* Main renal arteries diameter \< 4 mm
* Renal artery stenosis
* Iliac/femoral artery stenosis precluding insertion of the catheter
* Untreated allergy to contrast media
* Currently participating in the study of an investigational drug or device
* Moderate to severe renal insufficiency