cyrilzakka/clinical-trials huggingface dataset:
Resistive/Cardiovascular Training Study

This is a training study in healthy volunteers to characterize gains in lower-body resistive strength and cardiovascular capacity with exercise on a Combined Countermeasure Device (CCD) we have developed for the National Space Biomedical Research Institute. The CCD is a single platform which contains interchangeable modules for cardiovascular stepping exercises and lower body resistive exercises including squats, heel raises, abductor and adductor exercises and knee extension and flexion. The platform has the capability to tilt, yaw and pitch, and to translate in three dimensions in order to challenge the neurovestibular system. The underlying goal of the project is to provide a compact and efficient exercise modality that will prevent deterioration of the cardiovascular and musculoskeletal systems, and the neurovestibular system, in long-duration spaceflights. The goal of the current study is simply to test the hypothesis that in healthy volunteers, the exercise prescription proposed for the device will improve strength and VO2 max. Subjects are tested for lower body resistive strength and V02max at baseline, then are trained for 12 weeks, and tested again at followup to test for a change. 36 subjects, allowing for a 20% attrition rate, allows sufficient power to detect 95% percent confidence intervals in the changes in the strength and V02max measures of roughly 10-20%. If we observe gains in these indices which are similar to those reported in the literature for simultaneous cardiovascular and resistive strength protocols, then we believe that there is sufficient evidence to test CCD in a bedrest model of long-duration spaceflight.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* 25-55 years old
* Do not exercise on a regular basis

Exclusion Criteria:

Have not been diagnosed with hypertension, diabetes, high cholesterol, cardiovascular disease or asthma and other pulmonary disorders
The Efficacy and Safety of Huai er in the Adjuvant Treatment of COVID-19

In December 2019,a new type of pneumonia caused by the coronavirus (COVID-2019) broke out in Wuhan ,China, and spreads quickly to other Chinese cities and 28 countries. More than 70000 people were infected and over 2000 people died all over the world.There is no specific drug treatment for this disease. This study is planned to observe the efficacy and safety of Huaier granule in the adjuvant treatment COVID-19.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18 and 75 years, extremes included, male or female
2. Patients diagnosed with mild or common type COVID-19, according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)"
3. patients can generally tolerable for treatment recommended by the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)"
4. Patients have not been accompanied by serious physical diseases of heart, lung, brain, etc.,Eastern Cooperative Oncology Group score standard:0-1
5. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Female subjects who are pregnant or breastfeeding.
2. patients who are allergic to this medicine
3. patients meet the contraindications of Huaier granule
4. Patients with diabetes
5. Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.
6. patients can't take drugs orally
A Study of LW231 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection

To Evaluate the Tolerability and Pharmacokinetics of LW231 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects .

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of LW231 tablets in healthy volunteers and in chronic hepatitis B (CHB) patients after single and multiple doses. In addition, the study will evaluate the initial antiviral efficacy of LW231 in CHB patients following a multiple dosing regimen.

Eligibility Criteria:
Inclusion Criteria:

1.18-55 years old male or female. 2.Body Mass Index (BMI) between 18 to 28 kg/m2 (inclusive) and body weight equal to or over 45 kg for females and 50kg for males.

3.Healthy status will be defined as the absence of evidence of any active or chronic disease following a detailed medical and surgical history, concomitant drug use (including hormonal supplements), a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology, and urinalysis.

Exclusion Criteria:

1. Any clinically significant abnormalities in laboratory test results at screening. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility.
2. Participants who have donated over 450 mL of blood or blood products or had significant blood loss within three months prior to screening.
3. Heavy smokers (those who smoke greater than or equal to 5 or more cigarettes a day within three months prior to screening).
MIND (Management of Traumatic Brain Injury Diagnosis)

Procure blood specimens from individuals presenting to the emergency department with suspected brain injury.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent Form Signed
* 18 years of age or older
* For women of child-bearing age: Not known to be pregnant AND
* Head Trauma within 6 hours of ED presentation with Glasgow Coma Scores from 3-8 (Severe Injury), 9-13 (Moderate Injury), or 14-15 (Mild Injury); OR
* Head trauma within 6 hours of ED presentation with Glasgow Coma Score of 15; OR
* Bone fracture or poly-traumas, both with no head trauma

Exclusion Criteria:

* Known pre-existing neurological condition that causes observed symptoms
* Recent history of head injury or seizures (within 1 year of current ED presentation)
* Prisoner
Evoked Responses as Pharmacodynamic Biomarkers in Healthy and Schizophrenic Participants (MK-4334-007)

The primary purpose of this randomized, double-blind, placebo-controlled cross-over study was to record and measure 40 Hz-auditory steady-state response (ASSR) in healthy controls (HC) and participants with mild-to-moderate schizophrenia (SZ) to determine if the mean inter-trial coherence (ITC) magnitude derived from the 40 Hz-ASSR is lower in SZ than in HC at baseline.

This is a 2-part study. Part 1 was a 2-period study in which participants received either 21 mg nicotine patches and then placebo patches or vice versa, with each patch co-administered with placebo capsules, in a counterbalanced order. In Part 2, participants were randomized to receive either MK-4334 250 mg capsule or placebo capsule, each with placebo patches.

Eligibility Criteria:
Inclusion Criteria:

HC Participants:

* Is in generally good health
* Has no history of clinically relevant neuropsychiatric illness
* Is a mild-to-moderate tobacco user of ≥1-year duration, smoking the equivalent of \~10-15 cigarettes/day

Participants with Mild-to-Moderate SZ:

* Has a current diagnosis of SZ with a duration ≥1 year
* Is clinically stable and in the residual (non-acute) phase of illness for ≥12 weeks prior to the study
* Is stably maintained on a regimen of up to 2 first- or second-generation antipsychotics with no dose changes \>50% in combination with concomitant medication commonly prescribed to this population for ≥8 weeks prior to screening and during the study
* Is a mild-to-moderate tobacco user of ≥1-year duration, smoking the equivalent of \~10-15 cigarettes/day

All Participants:

* For males, agrees to be abstinent from heterosexual intercourse, or use an approved contraception method, during the study and for 90 days after the last dose of study drug
* For females, is not of childbearing potential
* Is willing to comply with restrictions on the use of nicotine or nicotine-containing products during the study

Exclusion Criteria:

HC Participants:

* Has known biological family history of psychotic disorder in a first or second degree relative

Participants with Mild-to-Moderate SZ:

* May be excluded from participation by the investigator based on treatment history and/or performance on various screening tests

All Participants:

* Is positive for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus (HIV)
* Is at imminent risk of self-harm
* Has had major surgery or donated blood within 4 weeks prior to screening
* Has evidence of cognitive impairment or significant mental disability
* Has a history of clinically significant abnormality or disease
* Has a history of cancer (malignancy)
* Is unable to refrain, or anticipates use, of any non-prescription drugs or herbal remedies
* Has participated in another clinical study within 6 weeks or 5 half-lives (whichever is greater) prior to screening
Tele-rehabilitation Versus Home Exercise Program in COVID-19

The aim of the study is to investigate the potential effects of face-to-face supervised tele-rehabilitation to home exercise program on walking speed, handgrip strength, muscle endurance, quality of life, physical activity level and perceived respiratory disability in COVID-19 patients who hospitalized in ICU due to ARDS and discharged from hospital.

COVID-19 could cause respiratory distress in a minority of cases and requires intensive care and mechanical ventilation. When patients recover and are discharged from hospital, physical, cognitive and emotional complications known as post-intensive care syndrome is seen in the majority of patients and requires rehabilitation.

Pulmonary rehabilitation is a comprehensive intervention consists of assessment of patient, exercise training and education in order to improve physical and psychological condition of people with chronic respiratory disease.

The patients with COVID-19 with post-intensive care syndrome will be randomized two groups: Tele-rehabilitation group and home exercise group. There will not be a non-exercising control group due to the ethical issues. The exercise program of both groups will be prescribed by a physiatrist based on the physical examination and the functional capacity of the patients.

Tele-rehabilitation group will perform the exercise program 3 days/week for 10 weeks. One session will include aerobic, flexibility and strengthening exercises for lower and upper extremity and breathing exercise.

The trainings will start with low-intensity exercises and intensity and duration of the exercises will progress according to the condition of the patient.

Intensity of the exercises will be monitored by Borg scale based on dyspnea and exertion symptoms during the sessions.

Home exercise group will perform the exercises at their home on their own, 3 days/week for 10 weeks. The patients will be trained about the individualised exercise program as the first session provided at the hospital. The physiotherapist will call the patients weekly, modifications in the exercise program will be made according to the patient's reports.

Outcomes will be measured at baseline, within 1 week of completion the program, 6th months and 12th months following the rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* To be older than 18 years
* To be discharged from ICU with a diagnosis of ARDS or severe pneumonia due to COVID-19
* To have ability to walk independently

Exclusion Criteria:

* To have dementia or cognitive impairment, symptomatic psychiatric illness, hearing or visual impairment that might interfere to follow the instructions
* To have a severe co-morbidity that exercise is contraindicated
Effects of Ramelteon on Driving Ability

The primary purpose of this study is to investigate the effects of bedtime administration of a single dose of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on next-morning on-road driving performance. In addition, the drugs' effects on balance are evaluated during the night, and the next morning residual effects on memory and psychomotor performance.


Eligibility Criteria:
Inclusion Criteria:

1. The subject is male or female, 21 - 55 years of age, inclusive
2. The subject is capable of understanding and complying with the protocol requirements.
3. The subject or the subject's legally acceptable representative signs a written, informed consent form prior to the initiation of any study procedures.
4. The subject, if female, is non-pregnant and non-lactating.
5. Possession of a valid driver's license for at least 3 years and a reported history of having driven at least 5000 km per year on average, for the last 3 years prior to entering into the trial.
6. An SDLP level at the end of the driving test of the dress rehearsal that does not exceed 24 cm. This dress rehearsal is performed at Visit 1.

Exclusion Criteria:

1. The subject has a known hypersensitivity to ramelteon, zopiclone or related compounds, including melatonin.
2. The subject has participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first night of double-blind study medication, whichever is longer.

5.History or presence of any clinically significant gastrointestinal, cardiovascular, hepatic, renal, haematological, endocrine, respiratory, neurological or psychiatric disease 6.History of primary insomnia (DSM IV-TR criteria) within the past 6 months. 7.The subject has used any medication with psychotropic effects (e.g. antidepressants, anxiolytics, antihistamines) within 30 days of the initial visit.
Post Mastectomy Hypofractionated Radiotherapy in High Risk Breast Cancer

The purpose of this study is to compare the efficacy and toxicities of hypofractionated radiotherapy with conventional fractionated radiotherapy in high risk breast cancer patients treated with mastectomy. It's hypothesized that the efficacy and toxicities are similar between the two groups.

Eligible breast cancer patients with mastectomy and axillary dissection are divided into two groups: conventional fractionated (CF) radiotherapy of 50 Gray (GY) in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region, and hypofractionated (HF) radiotherapy of 43.5 Gray (GY) in 15 fractions within 3 weeks to the same region. During and after radiotherapy , the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Ipsilateral clinically diagnosed and histologically confirmed invasive breast cancer
* Undergone total mastectomy and axillary dissection T 3-4 and/or 4 or more positive axillary lymph nodes.
* Fit for chemotherapy ( if indicated) , endocrine therapy (if indicated), and postoperative irradiation.
* Written informed concent.
* C T3-4 , or C N2, or pathological positive axillary lymph nodes during mastectomy for patients who had received neoadjuvant chemotherapy or hormone therapy.
* No supraclavicular or internal mammary nodes metastases.
* No distant metastases .Enrollment date no more than 8 months after surgery or no more than 2 months after chemotherapy for patients who did't receive neoadjuvant therapy.
* Enrollment date no more than 2 months after surgery for patients who had received neoadjuvant systemic therapy and did't need adjuvant chemotherapy.

Exclusion Criteria:

* Patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region
* Previous or concurrent malignant other than non melanomatous skin cancer
* Bilateral breast cancer.
* Immediate or delayed ipsilateral breast cancer reconstruction.
Treatment of Osteoarthritis of the Hip Joint With Intra-articular Injection of Microfractured Autologous Adipose Tissue Containing Mesenchymal Stromal Cells.

The aim of the study is to evaluate the safety and efficacy up to 12 months of MF-AT in the echo-guided infiltrative treatment of hip OA through clinical, subjective and objective evaluations.

For this pilot study, will be enrolled 30 patients with OA of the hip. All patients will be treated with a single infiltration of MF-AT obtained by the Lipogems® method. All activities of the present trial will be carried out at the Rizzoli Orthopaedic Institute (selection and enrollment, abdominal sampling, infiltrative treatment and follow-ups).

Patients will undergo infiltrative treatment after collecting informed consent for study participation and biographical data. Thereafter, patients will be followed up with clinical evaluation at 1-3-6-12 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 40 and 70 years;
2. Signs and symptoms of hip OA (pain intensity of at least 4 points and not more than 8 of VAS pain - 0-10 scale in the previous week);
3. Radiographic signs of hip OA (Grade 1-2 according to Tonnis classification) or MRI signs (chondropathy or minimal labrum degeneration without acute lesions) even if Grade 0.
4. Unilateral involvement;
5. Ability and consent of patients to actively participate in clinical follow-up;
6. Signature of informed consent.

Exclusion Criteria:

1. Patients unable to express consent;
2. Patients undergoing infiltration of other substance in the previous 6 months;
3. Patients undergoing lower limb surgery to be treated in the previous 12 months;
4. Patients with malignant neoplasms;
5. Patients with rheumatic diseases;
6. Patients with uncontrolled diabetes;
7. Patients with uncontrolled thyroid metabolic disorders;
8. Patients abusing alcoholic beverages, drugs or medications;
9. Body Mass Index \> 35;
10. Pregnant and/or fertile women.
11. Pain intensity less than 4 points or greater than 8 in accordance with the VAS scale.
12. Patients with other hip pathologies: acetabular protrusion, concentric migration of the femoral head, presence of excessive deformity resulting from acetabular or femoral head dysplasia, collapse deformity, and deformed femoral head sequelae of Perthes disease or osteonecrosis of the femoral head.
13. Previous extensive surgery of the reference joint (osteotomy around the hip, open or arthroscopic osteochondroplasty for femoro-acetabular conflict).
The Effect of Disaster Midwifery Education Program on Disaster Risk Perception and Self-Efficacy Levels of Midwifery Students

This research was planned to examine the effect of disaster midwifery education on the disaster risk perception and self-efficacy levels of midwifery students. The research universe will consist of third-year students studying at the Department of Midwifery, Hamidiye Faculty of Health Sciences (HSBF), Health Sciences University (SBU) in the spring semester of the 2023-2024 academic year (N: 80).

In this semi-experimental pre-test and post-test design and control group planned research, in order to determine the sample size; the data were normally distributed, the standard deviation of the main mass was estimated as 1 and the effect size (effect size, difference) as 0.8.

For the analysis to be conducted, it was calculated that the highest power value of the research would be 0.942182 in the case of taking two independent n₁=40, n₂=40 samples at a 5% significance level. The G-power analysis result is given below. Students who volunteer to participate in the study will be assigned to the intervention and control groups using the computer-aided simple random sampling method. Computer-aided randomization will be used in the study, and the number of cases will be entered through the program with the URL address https://www.randomizer.org and random assignment will be made to the intervention and control groups. The study will be conducted single-blind. Midwifery students will be administered the "Disaster Risk Perception" and "Self-Efficacy Scale in Disaster Intervention" before and 8 weeks after the first training. Each training period is limited to 60 minutes, once a week.


Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in the research.
* Health Sciences University, Hamidiye Health Sciences Faculty Midwifery Department Being an active student in the 3rd year.

Exclusion Criteria:

* Being a passive student in the 3rd year of the Department of Midwifery, Hamidiye Faculty of Health Sciences, University of Health Sciences.
The Effect of Immediate Smoking Cessation Interventions for Smokers With Chronic Airway Diseases

Smoking cessation support is provided by smoking cessation outpatient clinics in our country. Smokers with chronic airway diseases can also apply to these services by making an appointment from quit lines. Quit rates of that group patients were found to be similar to the general population. In novel smoking cessation support approaches immediate cessation support is reported to be more effective than routine practice. The sample in these studies consists of individuals who applied for lung health screening programmes. There is no study in the literature examining the effect of this immediate support on patients with chronic airway diseases' quit success. Our aim with this study is to examine impact of immediate cessation support by getting an appointment to the same cessation clinic instantly on our sample's cessation success.

Patients who are current smokers (who have smoked at least 100 cigarettes in their lifetime and still smoke daily or some days) will be randomized in a 1:1 ratio to the two arms in sequential order of presentation, after they have been identified and given written informed consent about the study. Demographic and clinical features will be filled. A brief smoking cessation intervention will be applied to one group and they will be recommended to apply to smoking cessation outpatient clinics by obtaining appointment from quit lines, as the way of current routine practice. Those randomized to the other group will have an immediate appointment at the smoking cessation outpatient clinic in addition to the brief smoking cessation intervention. Both patient groups will be called after 1 week by phone to inquire about their smoking cessation status and their application to smoking cessation outpatient clinics. Both groups will be called again in the 3rd month and their smoking cessation status, their application to smoking cessation outpatient clinics, and the duration/status of using pharmacological smoking cessation treatments will be questioned.

Eligibility Criteria:
Inclusion Criteria:

1. Being age 18 years and over,
2. Having diagnoses of asthma and/or COPD and/or bronchiectasis for at least 6 months,
3. Applying to the chest diseases outpatient clinics,
4. Being an current smoker,
5. Those who agree to participate in the study,
6. Patients who can be reached by phone calls at 1 week and 3 months after randomization.

Exclusion Criteria:

1. Those with active psychiatric disorders
2. Patients with impaired cognitive functions.