cyrilzakka/clinical-trials huggingface dataset:
Effect of an Exercise Rehabilitation Program on Symptoms in Hemodialysis

The purpose of this study is to determine whether participation in a 26-week exercise rehabilitation program is effective at reducing symptom burden and improving quality of life in individuals receiving chronic hemodialysis.

Individuals with end-stage kidney disease requiring HD suffer from multiple symptoms, which have limited effective treatments. Symptom burden, the combined impact of number and severity of symptoms, negatively impacts functional status and health-related quality of life (HRQOL) in HD. Small interventional trials suggest exercise can mitigate specific individual symptoms, but impact of exercise on overall symptom burden in HD is unknown. Dialysis patients have identified improving symptom burden and HRQOL as research priorities. We propose the first randomized controlled trial (RCT) investigating the effect of exercise rehabilitation on symptom burden in individuals on HD.

Hypothesis: In individuals on HD, participation in a 26-week exercise rehabilitation (rehab) program will reduce symptom burden and improve HRQOL, resulting in reduced disability and improved long-term clinical outcomes as compared with standard care.

Study Design: Single-centre RCT with one-to-one parallel design, allocation concealment and assessor blinding

Study Population: Adults receiving chronic in-centre HD for \> 3 months with at least one dialysis-related symptom; n=150

Intervention: Standard care plus 26-week structured rehab program (lifestyle education, resistance exercise and cycling during HD).

Control: Standard care (baseline exercise counseling)

Outcomes measured at baseline, 12, 26 and 52 weeks.

Data Analysis: Will be performed on an intention to treat, available case basis with t-tests or Mann Whitney U for continuous outcomes, as per data distribution and Chi square tests for categorical outcomes. Mixed effects modeling will account for repeated outcome measures over time. Poisson regression will be performed for hospitalization analysis.

Anticipated Outcomes: Mean symptom burden severity score will decrease by 20% from baseline in the intervention group at 12 weeks. Due to sustained physical activity in the intervention group, symptom burden will remain lower in this group at 6 months. In contrast, the control group will see no improvement in symptom burden from baseline.

Eligibility Criteria:
Inclusion Criteria:

* greater than 3 months after starting chronic hemodialysis
* no planned change in hemodialysis modality or relocation outside of Winnipeg during study intervention period (26 weeks)
* assessed to be safe and able to exercise by HD unit nephrologist
* ability to communicate in English and provide informed written consent

Exclusion Criteria:

* acute coronary syndrome in past 3 months
* unstable arrhythmia
* shortness of breath at rest or with minimal activity (NYHA Class 4)
* symptomatic hypoglycaemia (\> 2x/week in week prior to enrolment)
* currently participating in the Manitoba Renal Program clinical intradialytic cycling program
* score of 0 on Dialysis Symptom Index when administered at time of consent
Feasibility Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Treatment of Non-Small Cell Lung Cancer

This study is a multicenter, open-label, two-arm, randomized, parallel Phase 2 feasibility study of pemetrexed in combination with either cisplatin (Arm A) or carboplatin (Arm B) as adjuvant combination-chemotherapy in participants with completely resected, stage Ib or IIa/IIb non-small cell lung cancer (NSCLC).

A two-stage design will be employed independently for both treatment arms, with the possibility of stopping each treatment early for lack of feasibility.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven non-small cell lung cancer stage Ib, IIa or IIb
* Must have complete tumor resection by pneumonectomy or lobectomy
* Must have been surgically proven to be N2 negative

Exclusion Criteria:

* Serious concomitant systemic disorder
* Post-operative complications or other surgery related conditions
* A prior malignancy other than NSCLC unless that malignancy was diagnosed and treated at least 5 years ago
Prophylactic Quetiapine on Delirium Prevention in Critically Ill Patients

The purpose of this study is to evaluate the efficacy of low dose quetiapine for the prophylaxis of delirium in critically ill patients in medical intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 19 years of age, admitting to medical ICU, anticipated to stay more than 72hours

Exclusion Criteria:

* Female patients who are pregnant or breastfeeding
* active delirium
* Received other anti-psychotic drug before attend the study
* severe bradycardia
* alcohol intoxication
* No written consent from the legal representatives
* Being ill with renal or hepatic failure
Non-dispensing Study to Check Prescription Equivalence of Two Daily Disposable Toric Contact Lens Types

The purpose of this study is to determine whether the prescription determined for a new daily disposable toric contact lens will be a good match to a prescription determined for an existing brand of lens.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must be between 18 and 40 years old.
2. The subject must have normal eyes.
3. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
4. The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.
5. The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00 DS in each eye.
6. The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye.
7. The subject's refractive cylinder axis must be 180 +/- 30 in each eye.
8. The subject must be an adapted wearer of soft toric contact lenses in both eyes.
9. The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye.
10. Subjects must already possess a wearable pair of spectacles. -

Exclusion Criteria:

1. Ocular or systemic allergies or disease that may interfere with contact lens wear.
2. Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear.
3. Clinically significant corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
4. Clinically significant tarsal abnormalities that might interfere with contact lens wear.
5. Any ocular infection.
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
7. Pregnancy or lactation
8. Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
9. Diabetes
10. Strabismus -
Auricular Acupuncture for Primary Insomnia

This double-blind RCT will evaluate the therapeutic effectiveness and safety of auricular acupuncture(AA) for primary insomnia(PI) .

Investigators will conduct a 2-year clinical trial on auricular acupuncture (AA) for primary insomnia (PI), which is a double-blind (patient-blind and assessor-blind) RCT. 288 patients will be randomly assigned into 2 groups: the treatment group (Group A) and the control group (Group B). Group A will be treated with AA plus oral Eszopiclone, while Group B will be treated with sham AA plus oral Eszopiclone. All patients will receive a continuous 4-week treatment and 28-week follow-up. The data will be analyzed by the third party who is not clear about allocation and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnosis of PI according to DSM-5;
* Aged 18-64 (including 18 and 64);
* Provided a signed written consent form.

Exclusion Criteria:

* The patient has somatic disease like severe respiratory, circulatory, endocrine system disease and hepatic/renal insufficiency;
* The patient suffers from moderate / major depression (BDI score ≧ 8 points), moderate / severe anxiety disorder (SAS score ≧ 61 points) or any other serious mental disease;
* The patient who abuse drug alcohol or substance;
* The patient suffers from dementia or any other severe cognitive impairment;
* The patient is in pregnancy or lactation period;
* Patient who is a night worker or stick to irregular sleep pattern, and can't or don't want to terminate this kind of work mode;
* The patient has history of suicide or suicidal tendency;
* The patient is allergic to Eszopiclone or any other sedative-hypnotic drugs;
* The patient who has taken psychiatric, hypnotic or antihistamine drugs during the last 4 weeks before baseline, however, the patient who use the prescription or nonprescription hypnotic drugs no more than twice a week can be recruited as soon as drug withdrawal;
* The patient who is receiving ongoing psychological treatment;
* The patient who has obstructive sleep apnea, restless leg syndrome, sleep rhythm disorders, parasomnias, etc.
Sex Steroids, Sleep, and Metabolic Dysfunction in Women

Increased plasma triglyceride concentration is a common feature of the metabolic abnormalities associated with obesity and a major risk factor for cardiovascular disease. Obesity is a major risk factor for two conditions that appear to be increasing in prevalence in women: the polycystic ovary syndrome (PCOS) and sleep disordered breathing. PCOS affects 5-8% of women. Sleep disordered breathing affects up to 10% of women. Obstructive sleep apnea (OSA) is the most common cause for sleep disordered breathing and particularly prevalent in obese women with PCOS (\~50%). Both PCOS and OSA augment the increase in plasma triglyceride (TG) concentration associated with obesity, and the effects of PCOS and OSA on plasma TG concentration appear to be additive. The mechanisms responsible for the adverse effects on plasma TG metabolism are not known. The primary goal of this project, therefore, is to determine the mechanisms responsible for the increase in plasma TG concentration in obese women with PCOS and OSA. It is our general hypothesis that alterations in the hormonal milieu that are characteristic of these two conditions are, at least in part, responsible for the increase in plasma TG concentration in obese women with the conditions. Furthermore, we hypothesize that the hormonal aberrations characteristic of the two conditions are particularly harmful to obese, compared with lean, women.

The effects of PCOS on skeletal muscle protein metabolism are also not known. However, sex hormones are thought to be important regulators of muscle protein turnover suggesting that muscle protein metabolism is likely to be affected by PCOS. We will examine this by determining the effect of individual sex hormones on muscle protein metabolism and hypothesize that testosterone administration will stimulate muscle protein metabolism while estrogen and progesterone administration will inhibit muscle protein metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-75 years and men 45-75 years
* Healthy lean, overweight and obese women (BMI 18-40 kg/m2) and obese men (BMI 30-40 kg/m2)
* Obese women (BMI 30-40 kg/m2) with OSA or PCOS

Exclusion Criteria:

* Pregnant, lactating, peri- or postmenopausal women will be excluded from the study because of potential confounding influences of these factors and potential ethical concerns (pregnant women)
* Women taking medications known to affect substrate metabolism and those with evidence of significant organ dysfunction (e.g. impaired glucose tolerance, diabetes mellitus, liver disease, hypo- or hyper-thyroidism) other than PCOS and OSA
* Severe hypertriglyceridemia (fasting plasma TG concentration \>400 mg/dl)
* Subjects with OSA who have an apnea-hypopnea index (AHI) score \>30 (the total number of obstructive events divided by the total hours of sleep) will be excluded and instructed to seek medical care
Modified Surgical Technique for Lateral Block Augmentation Prior to Implant Installation

Evaluation of the surgical result (augmentation volume, proportion of newly formed bone) after perforation of the bone block in the course of lateral block augmentation prior to planned implant installation.


Eligibility Criteria:
Inclusion Criteria:

* single tooth gap in need of lateral bone augmentation prior to implant installation

Exclusion Criteria:

* untreated periodontal disease
* systemic disease and/or medication intake with significant effect on bone healing
Effector and Regulatory T Cell Receptor Repertoire Analyses in Patients Affected by COVID-19

The specificity of the adaptive immune response (AIR), and its balance between effector T cells (Teffs) and regulatory T cells (Tregs), is most likely a major determinant of the outcome of a Covid-19 infection.

We aim to analyze (i) the cellular components and (ii) the specificity of the AIR to COVID-19 in 60 patients with moderate and severe form of the disease. This should have important implications for (i) understanding the pathophysiology of the disease, (ii) discovering biomarkers of severity and (iii) designing treatments and vaccines.

The quality of the adaptive immune response (AIR) to COVID-19 probably determines the course of the disease. Therefore, a comprehensive knowledge of the immune response to COVID-19 is required to better anticipate its outcome and identify vaccine targets. In particular, the quality of an AIR can be investigated by immunophenotyping (enumerating immune cells and assessing their fitness) and by analyzing the T cell receptor (TCR) repertoire.

The cellular components of the AIR will be analyzed by a deep immunophenotyping generating \>800 measures assessing immune cells quantitatively and qualitatively (Pitoiset et al.,2018). Combined with supervised and unsupervised analyses, it has the power to detect subtle/hidden abnormalities.

The specificity will be analyzed by studying the global T cell receptor (TCR) repertoire of separated Tregs and Teffs from peripheral blood, as well as by single cell sequencing of cells from bronchoalveolar lavages.

These combined approaches should uncover parameters/abnormalities of the AIR linked to the infection severity and outcome, and lead to a better understanding of the nature of the Tregs and Teffs repertoires against COVID-19. This will have important implications for (i) understanding the pathophysiology of the disease, (ii) discovering biomarkers of severity and (iii) designing treatments and vaccines.

Eligibility Criteria:
Inclusion criteria :

* Age≥18 and ≤75 years
* Presenting a confirmed diagnosis of COVID-19 disease in accordance with WHO diagnostic criteria;
* Good venous capital ;
* Affiliation to a social security system;
* Having declared his/her non-opposition to participation in research (for patients hospitalized in intensive care units who are not able to communicate, the non-opposition of a trusted person will be sought.)

Exclusion criteria :

* Still under the exclusion period from another biomedical study
* Psychiatric illness or addiction that could interfere with the ability to comply with the requirements of the protocol or to give consent to participate in the study;
* Patient benefiting from a legal protection measure
The Exploration for Pharmacodynamics and Pharmacokinetics of YH4808 New Formulation in Healthy Subjects

The objective of this clinical trial is to explore pharmacodynamics and pharmacokinetics of YH4808 New Formulation in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. healthy adult age 20 to 55 over 55kg with ideal body weight(BMI) 18.5 \~ 25
2. Subject who has no congenital, chronic disease and disease symptoms in medical examination result
3. negative to Helicobacter pylori in 13C urea breath test
4. Subject who judged to be eligible according to various test results including laboratory test(serum test, hematologic/blood chemistry examination, urine test, etc.) and 12-lead ECG test performed within 4 weeks before the first IP administration.
5. Subject who agreed to maintain contraception and comply with medically verified contraception methods (including infertility)

Exclusion Criteria:

1. Subject who has history or presence of clinically significant disease in liver, kidney, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, reproductive, musculoskeletal system, mental disorder, ophthalmologic disease, and skin disease in investigator's judgement.
2. Subject who has history of surgical operation or disease related to gastrointestinal symptoms (e.g. crohn's diseas, ulcer, etc. except for appendectomy or simple hernia) which could have influence on the absorption of IP.
3. Subject who is hypersensitive to components contained in YH4808 and other drugs(aspirin, antibiotics, etc.)
4. pregnant or lactating woman.
5. Other exclusions apply.
Calcium Dobesilate Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

The purpose of this study is to compare the effect of oral Calcium Dobesilate to oral Cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent intracytoplasmic sperm injection (ICSI).

Two hundred and twenty women at risk of ovarian hyperstimulation syndrome during ICSI cycles will be randomly scheduled into two equal groups. In group A, (Calcium Dobesilate group), 1 cap / 8 hs Doxium ( 500mg) will be given at day of HCG injection and for 21 days; while in group B (Cabergoline group), 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for 8 days.

Eligibility Criteria:
Patients enrolled in the study were infertile women undergoing ICSI with one of the following criteria: previous episodes of OHSS, polycystic ovaries (i.e., \> 24 antral follicles present on baseline ultrasound examination), high AMH (\> 3.0 ng/mL), large number of small follicles (8 to 12 mm) seen on ultrasound during ovarian stimulation, high s.E2 at hCG trigger (E2 \>3000 pg/ml or rapidly rising s.E2), presence of \> 20 follicles by ultrasound on day of retrieval or large number of oocytes retrieved (\> 20).

Exclusion Criteria:

* None
Increasing Household Purchase and Child Consumption of Calcium Products

The objective of this research is to test the effectiveness of persuasive messages targeted at parents who have children who consume inadequate amounts of calcium. Specifically, the effectiveness of the intervention material on increase a) the purchase of calcium-rich products by parents, and b) the consumption of calcium-rich products in the parent and child will be examined in 400 families across Canada. Families will receive either the targeted intervention materials or standard of care generic nutrition materials retrieved from Health Canada's website. Materials will be delivered to parents during weeks 0, 8, 16, and 22 of the study. Monitoring of parents' calcium product purchases and consumption behaviour in both parents and children will occur at week 0,12, 24 weeks (immediately post-intervention) and at 52 weeks (i.e., 6-month follow-up). Purchases will be verified by grocery receipts made during the aforementioned weeks. Parents will self-report on their dietary consumption as well as their child's using a food frequency questionnaire. The study hypotheses are as follows:

1. Parents in the experimental condition will purchase more calcium-rich products as compared to parents in the control condition.
2. Parents and children in the experimental condition will consume more calcium rich products as compared to parents and children in the control condition.
3. Perceived outcome expectancies of consuming calcium-rich products will increase to a greater extent in parents in the experimental condition as compared to parents in the control condition.
4. Self-regulatory efficacy to consume calcium-rich products will increase to a greater extent in parents in the experimental condition as compared to parents in the control condition.
5. Perceived social support and role modelling behaviour will be highest in parents in the experimental condition as compared to parents in the control condition.
6. Self-regulatory efficacy and outcome expectancies will mediate the changes in calcium-rich product purchases and consumption.


Eligibility Criteria:
Inclusion Criteria:

* Parent of a child between the ages of 4 and 10
* The child consumes less than the recommended daily intake of calcium (1300mg for youth aged 9-10 and 1000mg for children aged 4-8)
* Parent and child have no dietary restrictions, allergies, or medical reasons for limiting intake of dairy products
* Parent can read and speak English

Exclusion Criteria:

* Dietary restrictions, allergies, or medical reasons for limiting intake of dairy products
Impact of COVID-19 Pandemic on Early Spontaneous Abortions and Early Termination of Pregnancy

To see the impact the COVID-19 pandemic has had on early spontaneous abortions and early termination of pregnancy in the first trimester

To date, the research has focused on the complications of SARS-CoV-2 in pregnant women. There is no research in the literature that has compared the rates and behavior of miscarriage during the time of the COVID-19 pandemic to before the time of the pandemic. As described in the literature, there is an established connection between COVID-19 and stress, anxiety, and depression. There is also an established connection between stress, anxiety, and depression and rates of miscarriage. The investigators hereby wish to analyze the effect of the COVID-19 pandemic on miscarriages.

In this study, The investigators will analyze the number of early missed abortions and number of termination of pregnancies in the first trimester before and during the COVID-19 pandemic. The investigators will also analyze the time interval between diagnosis of missed abortion and attendance to E.R in missed abortions during the COVID-19 pandemic. In addition, The investigators will be comparing the reasons for termination of pregnancy during this time, as well as analyzing age, religion, and demographic variables during the COVID-19 pandemic compared to years prior.

Eligibility Criteria:
Inclusion Criteria:

* All women attending for early missed abortion or termination of pregnancy receiving treatment between March 11th - November 30th during the years 2017-2020 Gestational age until 12 weeks 6 days (1st trimester only)

Exclusion Criteria:

* Incomplete and complete abortions
* Gestational age \>13 weeks