cyrilzakka/clinical-trials huggingface dataset:
Energy Supply in Athletes and Untrained Persons With Bronchopulmonary Diseases

Study of the energy supply of bicycle ergometric load in athletes and untrained persons with bronchopulmonary diseases (community-acquired pneumonia, bronchitis, chronic obstructive pulmonary disease and acute respiratory viral infections, to justify the timing of the resumption of training, as well as determination of the volume and intensity of physical activity in training and competitive processes.

1. The aim of the study is to assess energy supply of bicycle ergometric load in athletes and untrained persons who have suffered diseases of the bronchopulmonary system (community-acquired pneumonia, bronchitis, chronic obstructive pulmonary disease and acute respiratory viral infections, to justify the timing of the resumption of training, as well as determining the volume and the intensity of physical activity in the training and competitive processes.
2. In addition to a comprehensive general clinical, radiological (for community-acquired pneumonia) and laboratory examination, all the subjects under study will undergo special studies: spirography and spiroergometry, electrocardiography (ECG), and bicycle ergometry.
3. The main indicators of the functional state of the cardio-respiratory system of the study participants are indicators of the function of external respiration and gas exchange, recorded in the initial state, after load and in the recovery period of 10 and 30 minutes.

Patients with diseases of the bronchopulmonary system will receive treatment according to generally accepted standards of drug treatment.

Eligibility Criteria:
Inclusion Criteria:

1. the presence of written informed consent of the patient to participate in the study;
2. athletes (men and women) with a diagnosis of community-acquired pneumonia / bronchitis / chronic obstructive pulmonary disease / acute respiratory viral infection on days 28-31 from the onset of the disease, i.e. in the stage of clinical recovery;
3. untrained individuals (men and women) with a diagnosis of community-acquired pneumonia / bronchitis / chronic obstructive pulmonary disease / acute respiratory viral infection;
4. age 17 - 25 years.

Exclusion Criteria:

1. refusal of the patient from further participation in the study;
2. non-compliance with treatment recommendations and regimen.
WalkIT Arizona: Walking Interventions Through Texting

The purpose of this study is to develop adaptive (AI) and micro-incentive (MI) interventions and test them against static (SI) and delayed-incentive (DI) interventions in a 4-arm randomized factorial trial to increase MVPA adoption and maintenance among inactive adults. Using neighborhood walkability and socioeconomic status, participants will be recruited from four neighborhood types: "high walkable/high SES," "high walkable/low SES," "low walkable/high SES," and "low walkable/low SES." We will evaluate synergistic or antagonistic effects of interventions and neighborhood factors on MVPA adoption by 12 months and maintenance by 24 months.


Eligibility Criteria:
Inclusion Criteria:

* women and men of all races/ethnicities living in Maricopa County, Arizona

Exclusion Criteria:

* Live in one of the eligible neighborhood quadrants in Maricopa County, Arizona
* Adult men and women between 18 and 60 years old
* Inactive as screened by the International Physical Activity Questionnaire (IPAQ) short form and confirmed by baseline accelerometer measures
* No history of heart failure or type 2 diabetes
* No contraindications to exercise testing or requirement for medically supervised exercise (assessed by Physical Activity Readiness Questionnaire+ (PAR-Q+).
* Not currently pregnant and not planning to becoming pregnant in the next 2 years
* Not currently participating in physical activity, diet, or weight loss programs
* Daily access to a mobile phone with text messaging capabilities or an iOS or Android smartphone
* Willing to wear a small accelerometer on the wrist daily for 1 year
* Willing to send and receive 2-3 text messages per day for 1 year
* Not planning to be outside of Maricopa County for \> 30 days consecutively in the next 2 years
* Not planning to move from their current home in the next 2 years
Comparison of Posterior Ocular Changes Between Singleton Pregnancy and Multifetal Pregnancy.

It has been known that a pregnant women undergoes significant anatomical and physiological changes that mainly caused by hormonal and hematologic changes during pregnancy. Due to advance in reproductive medicine, the incidence of multifetal pregnancy was increased to 3% of livebirth. Multifetal pregnancies produce much more physiological changes in the body compared to the singleton pregnancies.

Physiologic ocular changes during pregnancy are the followings

* Melanogenesis of eyelid and facial skin
* Cellular alteration of lacrimal and meibomian gland
* Increased corneal thickness and corneal curvature
* Increased lens thickness
* Increased retinal vascular density
* Increased choroidal thickness Decreased intraocular pressure -

From the literature review, there was only on study of ocular changes in twin pregnancies. Alim et al evaluated the choroidal and retinal thickness in singleton versus twin pregnancies. They included 20 single and 20 twin pregnant women in their 3rd trimester with 20-age-matched healthy non-pregnant women as a control group. They found that there was an increase in choroidal thickness in the 3rd trimester of pregnancies and it was prominent in twin pregnancies. There was a statistically significant difference in choroidal thickness between pregnant and non-pregnant women, but not significant difference between singleton and twin pregnancies. The mean retinal nerve fiber layer thickness was significantly higher in the twin pregnancy group than in the singleton pregnancy group. However, no study of retinal vascular density in twin pregnancies has been published before.

Eligibility Criteria:
Inclusion Criteria:

* 24-37 years
* 30-36 weeks of gestational age
* clear ocular media
* written informed consent

Exclusion Criteria:

* high risk pregnancies such as pre-eclampsia, gestational diabetic mellitus and asthma
* history of refractive error, spherical equivalent \> 3 diopters
* history of retinal diseases such as central serous chorioretinopathy and retinal vascular occlusion
* history of intraocular inflammation or endophthalmitis
* history of intraocular laser treatment
* history of intraocular surgery
The Effect of Aromatherapy Massage on Pain, Anxiety and Comfort

Patients in the intensive care unit (ICU) experience physical and psychological discomfort, including pain. Anxiety is a condition frequently encountered in the ICU. The hospital environment, especially the ICU, is reported as a significant cause of anxiety for patients. Comfort is a holistic, subjective and multidimensional concept that is affected by physical, environmental, social and psycho-spiritual contexts and changes over time and space. Comfort in intensive care is often associated with pain relief and end-of-life care. Assessment tools have been developed to measure patient comfort in the ICU, including levels of pain, delirium, and sedation. This work; Patients who are monitored in intensive care under high-flow and oxygen are treated with a mixture of lavender, thyme and eucalyptus oil (20 ml; lavender oil 5 drops, thyme oil 4 drops, eucalyptus oil 3 drops and 20 ml almond oil) twice a day for three days. This study was conducted to determine the effect of aromatherapy massage applied for a total of 30 minutes on some physiological parameters, pain, anxiety and intensive care comfort of the patients.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and over,
* Conscious patients,
* Staying in intensive care for 24 hours or more,
* Those with stable hemodynamic status,
* Receiving O2 therapy,
* Intubated patients, patients who have passed 24 hours after being extubated,
* Those whose saturation level is 85 and above

Exclusion Criteria:

* Patients with peripheral neuropathy or quadriplegia,
* Patients with open wounds on their body,
* Patients receiving analgesia and sedation infusion,
* Patients who are sedated,
* Patients in delirium,
* Patients with an allergy detected before starting the application,
* Patients with a GKS (Glasgow Coma Scale) score of 3 and below
The Aboriginal Youth Mentorship Program

Building on the successes of a communal, relationship based approach to Aboriginal youth mentoring in an after school physical activity program (AYMP), the investigators are evaluating a peer-led approach for diabetes prevention.

Building on the successes of a communal, relationship based approach to Aboriginal youth mentoring in an after school physical activity program (AYMP), the investigators are evaluating a peer-led approach for diabetes prevention. High school students volunteer as mentors, and develop an after-school program that they then deliver to children in grade 4. The mentors meet twice a week. The first day, they develop an activity plan and decide roles and responsibilities to ensure successful delivery of each activity. The second day, they deliver the program to the grade 4s, which incorporates a healthy snack, 45-minutes of physical activity, and educational games/activities. Our primary goal is to determine the health benefits of AYMP; guided by our youth mentors and community advisors, the investigators will also develop a number of research questions that will help us to better understand the social, emotional, physical and spiritual outcomes of the peer-led mentor program. To answer these questions, the investigators will train community members in both qualitative and quantitative methods. The quantitative outcomes of this study include physical activity, waist circumference, obesity rates, and self-esteem. Qualitative methods may include photovoice and focus group interviews. All of these will be used to assess the social determinants of health and contextual features of the program.

Eligibility Criteria:
Inclusion Criteria:

* Grade 4 students. We chose to intervene with youth in grade 4 for four primary reasons: (1) the large majority of youth in grade 4 are in tanner stage 1 and will not experience puberty-related weight gain during the school year; (2) previous experience by our group revealed that attendance throughout the school year is higher in students in grade 4 relative to students in grade 5 or 6; (3) students in grade 4 are old enough to perform low organized games included in the intervention; and (4) retention rates in the intervention are greater than students in grades 5 and 6.

Exclusion Criteria:

* While all students will be invited to participate in the intervention, for measurement purposes, we will exclude data from those students who may not respond to the intervention or would be unable to participate in the physical activity aspects of the component. This includes children with: (1) musculoskeletal injuries that limit physical activities; (2) treatment for chronic conditions that would elicit weight gain or limit participation in physical activity (insulin, corticosteroids, blood pressure medications); (3) poor attendance (\<60% of school days) in the first semester; (4) children whose parents are unwilling to provide consent. Note: the intervention will be offered to youth with chronic conditions, however their data will not be included in the final analysis, due to confounding effects of medications.
The Diagnostic Performance of Tilt Test in Athletes

In the present study the investigators evaluate the sensitivity and specificity of passive tilt test in athletes, as well as their haemodynamic responses and autonomic nervous system activity during head-up tilt. Moreover, the investigators try to apply a novel algorithm for the improvement of diagnostic yield of tilt test in athletes.

We examine athletes with a history of reflex syncope and athletes without history of reflex syncope.All subjects undergo a tilt test, for the evaluation of haemodynamics, heart rate variability (HRV) and baroreflex sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* 14-40 years old,
* more than 5 years of exercise training experience and competition at a regional level at different sports

Exclusion Criteria:

* smoking,
* recent alcohol consumption,
* presence of any chronic disease and use of drugs
Simultaneous Versus Staged Resection for Initially Resectable Synchronous Rectal Cancer Liver-limited Metastasis

The purpose of this study is to investigate the safety and efficacy of simultaneous liver resections compared to staged hepatectomies of rectal cancer with liver metastasis and to compare the short and long-term survival between the two groups.

The optimal surgical strategy for treatment of patients with resectable synchronous rectal liver metastases remains controversial. To answer whether synchronous rectal cancer liver metastases (SLM) should be resected simultaneously with primary cancer or should be delayed, We conducted a randomized, controlled trial to compare the safety and efficacy of simultaneous versus delayed resection of the rectum and liver. Patients with rectal cancer and resectable SLM were randomly assigned to either simultaneous or delayed resection of the metastases. The primary outcome was the rate of major complications (Clavien-Dindo grade≥III) within 30 days following surgery. Secondary outcomes included disease-free and overall survival. A consecutive patients of rectal cancer with liver metastasis from ZhongShan hospital, Fudan university were enrolled and randomly assigned to simultaneous liver resections and staged hepatectomies. Post-operative complications, peri-operative mortality, long-term survival were compared.

Eligibility Criteria:
Inclusion Criteria:

* age\>=18 and \<= 75 years
* resectable primary rectal tumor
* remnant liver volume \>= 60%
* without other organ metastasis or peritoneum metastasis
* without contradiction of cardiac and pulmonary diseases
* American Society of Anesthesiologists (ASA) class I - II
* Histologically proved rectal adenocarcinoma

Exclusion Criteria:

* age \> 75 years
* unresectable primary rectal tumor
* remnant liver volume \< 60%
* with other organ metastasis or peritoneum metastasis
* with contradiction of cardiac and pulmonary diseases
* Tumors assessed as clinical complete response after preoperative radio- or chemoradiotherapy
* Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery
* Multiple colorectal tumors or other schedules needing for synchronous colon surgery
* Co-existent inflammatory bowel disease
* Pregnancy or lactation
* Patients received treatment other than preoperative radio- or chemoradiotherapy
Evaluation of Introcan Safety 3 Closed IV Catheter

Incidence and time of occurrence of blood leakage with the closed intravascular catheter Introcan Safety 3 in comparison to Introcan Safety


Eligibility Criteria:
Inclusion Criteria:

* need for intravenous access

Exclusion Criteria:

* n. a.
Spurring Innovation to Promote HIV Testing: An RCT Evaluating Crowdsourcing

Crowdsourcing may be a powerful tool to spur the development of innovative videos to promote HIV testing among key populations such as men who have sex with men (MSM) and transgender (TG) individuals. The purpose of this randomized controlled trial is to compare the effect of a crowdsourced video and a conventional video on first-time HIV testing among MSM and TG in China. The crowdsourced video was developed using an open contest, formal transparent judging, and an incentive of marketing promotion. The hypothesis is that a crowdsourced video will be equivalent (within a margin of 3%) to a conventional video in terms of self-reported first-time HIV testing within 3-4 weeks of watching the video.


Eligibility Criteria:
Inclusion Criteria:

* Born biologically male or identify as transgender
* 16 years or older
* Lifetime anal sex with another man
* Providing informed consent and active mobile phone number

Exclusion Criteria:

* HIV-infected
* HIV-tested ever in the past
Evaluating the Effectiveness of a New Way of Organizing Primary Health Care to Improve the Management of Alzheimer's Disease

The objective of the present study is to evaluate the effectiveness of a general practitioner (MG) management strategy guided by a multidimensional evaluation on the multidimensional score of fragility of patients with mild to moderately severe dementia, compared to those currently implemented (without the provision of such an assessment). The measurement of the respective effectiveness of the two types of care in primary care will itself be based on a multidimensional evaluation performed independently in the memory center having established the diagnosis of Alzheimer's disease. The secondary objectives are the evaluation of the impact of the strategy on the functional abilities of patients, the incidence of geriatric syndromes, cognitive functions, quality of life of the patient and the burden of the primary caregiver. The efficiency of the strategy will be assessed through a cost-effectiveness analysis. A survey of opinions will also be conducted among primary health care providers, carers and CMs on the implemented system.


Eligibility Criteria:
Inclusion Criteria:

* Patients with probable Alzheimer's disease, according to the criteria usually used in memory centers
* Aged over 64 years with mild to moderately severe dementia syndrome
* Volunteers for medical follow-up for a period of 20 months; Which the general practitioner attending agrees to participate in the research

Exclusion Criteria:

* Patients under 65 years old
* presenting with early cognitive decline or severe dementia
* Not meeting the clinical diagnostic criteria for Alzheimer's disease
* Refusing or unable to sign informed consent to participate
* Not voluntary for medical follow-up for a period of 20 months
* Whose general practitioner refuses to participate in the research
Medical Marijuana Use in HIV+ Patients: Probability Survey

More scientific information is needed about medical marijuana use among HIV positive patients. There is conflicting information about the use of marijuana, use of medical marijuana, and the associations between them and health status/health risk behaviors/health care utilization. In addition, it is not clear whether patients who participate in prospective clinical studies differ from participants who do not participate; if there are differences between those two groups, then this would limit generalizability of knowledge about these issues.

The goal of this project is to describe the use of marijuana among HIV positive patients and its association with health status/health risk behaviors/health care utilization.

Participants will answer questions about marijuana, medical marijuana, and other drug use. We will also ask about health and steps participants take to keep healthy. The study will take up to one hour to complete.

Participants will also be asked to sign a release of information form. This form would allow us to look at medical records at the HIV clinic.

Eligibility Criteria:
Inclusion Criteria:

* Patients in the HIV clinic
* HIV positive

Exclusion Criteria:

* Lack of english
Clinical Study of PTFE Covered Stent for Treating Portal Hypertension

To validate the safety and efficacy of TIPS (Transjugular Intrahepatic Portosystemic Shunt) using PTFE covered stent in the treatment of portal hypertension.

This trial is a prospective multi-center single-arm confirmatory study. A total 177 subjects will be enrolled in multiple centers nationwide. Subjects who meet the trial requirements, fulfill the inclusion criteria, voluntarily participate in the study, and provide informed consent will undergo TIPS using the PTFE covered stent for the treatment of portal hypertension. Follow-up assessments will be conducted at discharge, as well as at 30 days, 90 days, 180 days and 360 days postoperatively. Secondary endpoint measures include surgical success rate, all-cause mortality, device/procedure-related mortality, incidence of adverce events, and serious adverse event rates. The trial aims to comprehensively assess the safety and efficacy of the PTFE covered stent produced by Enlight Medical Technologies (Shanghai) Co., Ltd..

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible for this study:

* Age 18-85 years;
* Cirrhotic portal hypertension required for TIPS;
* Willingness to comply with the protocol requirements and ata collection procedures, ability to understand the purpose of the trial, voluntary participation, and signing of informed consent by the subject or legal guardian.

Exclusion Criteria:

Subjects meeting any of the following criteria are not eligible for this study:

* Concomitant chronic heart or lung disease;
* Presence or suspicion of active systemic, hepatobiliary or ascitic fluid infection;
* Severe hepatic failure (with bilirubin levels of \>51.3μmol/L or Child-Pugh \>13 or MELD \>18);
* Hepatic encephalopathy;
* Coagulation disorders;
* Portal vein thrombosis;
* Allergies to device components;
* Extrahepatic malignancy;
* Pregnant or brestfeeding women or those planning pregnancy during the trial peroid;
* Intending or currently participating in another interventional clinical trial;
* Other conditions deemed inappropriate for participation in this study by the investigator.
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo

The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI.
* Total body vitiligo area does not exceed 10% BSA.
* Pigmented hair within some of the areas of vitiligo on the face.
* Must agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit.
* For sexually active participants (except participants who are prepubescent) willingness to avoid pregnancy or fathering a child from screening through 30 days after the last application of study cream.

Exclusion Criteria:

* Diagnosis of other forms of vitiligo (eg, segmental).
* Other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).
* Any other skin disease that, in the opinion of the investigator, would interfere with the study drug application or study assessments.
* Prior or current use of depigmentation treatments (eg, monobenzone).
* Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including application of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
* Use of protocol-defined treatments within the indicated washout period before baseline.
* Current or previous use of JAK inhibitors, systemic or topical.
* Protocol-defined clinically significant abnormal laboratory values at screening.
* BMI-for-age \< 5th percentile or ≥ 85th percentile according to the CDC BMI Percentile Calculator for Child and Teen.
* Pregnant or lactating participants or those considering pregnancy during the period of their study participation.
* In the opinion of the investigator, unable or unlikely to comply with the application schedule and study evaluations.
* Living with anyone participating in any current Incyte-sponsored ruxolitinib cream study.
* Employees of the sponsor or investigator or are otherwise dependents of them.
* Known allergy or reaction to any component of the study cream formulation.

Other protocol-defined Inclusion/Exclusion Criteria may apply.