cyrilzakka/clinical-trials huggingface dataset:
Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial (DECLARE) is a multi-center, outcome-masked, randomized clinical trial. The purpose of this study is to compare glaucoma drainage device implantation in the anterior chamber (front part of the eye) and sulcus (small space between iris and front chamber of the eye) in efforts to minimize cell loss in the eye.

The DECLARE Trial is a prospective 1:1 randomized, parallel design, double-masked clinical trial to compare endothelial cell density (ECD), intraocular pressure (IOP) and metagenomic RNA deep sequencing (MDS) between sulcus and anterior chamber (AC) tube placement after glaucoma drainage device (GDD) implantation.

The trial has fixed sample size with 12 months follow-up for primary outcome assessment and trial participants will continue to be followed to the end of grant cycle with a total of 24 months follow-up.

Patients will be randomized to 2 tube locations for GDD implantation:

* Tube placed in the AC
* Tube placed in ciliary sulcus
* Stratification: by clinical center and type of surgery (GDD alone vs GDD combined with phacoemulsification). Stratified randomization by clinical center is to ensure that a similar number of subjects will be randomized to either sulcus tube or AC tube placement for a specific clinical center. Because eyes undergoing a combined phacoemulsification with GDD implantation may be associate with larger ECL from phacoemulsification, stratified by surgery type is to ensure two tube location groups similar number of study eyes that will undergo a combined phacoemulsification with GDD implantation.

Eligibility Criteria:
Inclusion Criteria:

* Medically uncontrolled glaucoma requiring GDD or GDD combined with phacoemulsification as the planned surgical procedure
* Candidate for GDD implantation for ciliary sulcus and AC tube
* Age greater than or equal to 18 years old

Exclusion Criteria:

* Preexisting corneal condition that would affect the corneal endothelium or previous corneal transplant
* Previous GDD implantation or Xen Gel Stent or placement of Cypass Micro-stent or Preserflo MicroShunt
* Previous trabeculectomy and/or minimally invasive glaucoma surgery within the past 6 months
* AC intraocular lens
* Presence of nanophthalmos, uncontrolled uveitis, silicone oil, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure
* Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits
* No light perception vision in the study eye or fellow eye visual acuity \< 20/200
* Need for glaucoma surgery combined with other ocular procedures (i.e. corneal transplant, or retinal surgery) or anticipated need for additional ocular surgery
Prospective Pilot Study of Pre-Transplant Thymoglobulin Administration in Living Donor Renal Transplant Recipients

To determine how safe and effective giving Thymoglobulin before transplantation to patients who are going to be receiving kidney transplants.

We will evaluate the therapeutic efficacy of administering Thymoglobulin® induction pre-transplantation in renal allograft recipients. Patients receiving pre-transplant Thymoglobulin will be evaluated for acute rejection (Banff '97 criteria), survival, and safety at 6 months. Overall the use of Thymoglobulin induction pre-transplantation will be safe and effective.

Eligibility Criteria:
Inclusion Criteria:

1. Adult living donor renal transplant recipient.
2. Patient is at least 18 years of age
3. If female and of childbearing potential, have a negative serum or urine HCG within 24 hours prior to Study Day -5 (Day of 1st Thymoglobulin dose) and must practice a medically approved method of birth control for the past 30 days prior to enrollment and agree to continue this practice during the 6 month efficacy analysis.
4. Signed informed consent.

Exclusion Criteria:

1. Human Leukocyte Antibody (HLA) identical living donor transplant recipient.
2. History of a positive cross-match with the donor.
3. Patients with a peak CDC PRA \> 50% or a current CDC PRA \> 25%.
4. Patients who have previously received a kidney transplant.
5. Active donor or recipient serology positive for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
6. History of noncompliance.
7. History of chronic corticosteroid or immunosuppressive use except for inhaled corticosteroids to treat asthma. .
8. Multiple organ transplant recipient.
9. Patient with a urinary bladder that is absent or not functional (e.g. self catheterization) pretransplant.
10. Patient who does not agree to use effective birth control during the 6-month efficacy analysis.
11. Known contraindication to administration of rabbit antithymocyte globulin.
12. Initial screening laboratory evaluations will be done locally before renal transplantation and the following laboratory values will be exclusionary: Platelets \< 100,000/mm23 or WBC \< 3000/mm3
13. Currently abusing drugs or alcohol or, in the opinion of the investigator, is at high risk for poor compliance.
14. Patient who, in the opinion of the investigator, has significant medical or psychosocial problems or unstable disease states that would preclude participation in the study. Examples of significant problems include, but are not limited to, morbid obesity or severe cardiac disease.

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Comparison of Volatile Anesthetics on Cerebral Oxygenation During Controlled Hypotension

Controlled hypotension is a preferred method for reducing surgical bleeding during septoplasty operations however, the level of hypotension and bradycardia should not disrupt cerebral oxygenation. On this account, the investigators aim to investigate the effects of different volatile anesthetics combined with a short-acting opioid on cerebral oxygenation during controlled hypotension using near infrared spectroscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients in American Society of Anesthesiology (ASA) classification I and II
* Patients undergoing elective septoplasty operation

Exclusion Criteria:

* Patients in ASA classification III and higher
* Emergency surgery
* Patients in New York Heart Association classification III-IV
* Patients with known allergy to drugs used in the study
Efficacy and Safety Study of Combigan and 0.5% Timoptic in Normal Tension Glaucoma

Purpose To evaluate efficacy and safety of combigan(Brimonidine/Timolol) and 0.5% Timoptic (Timolol) ophthalmic solutions in normal tension glaucoma patients.

* Normal tension glaucoma (NTG) is the major type of glaucoma in Korea. (over 90% of glaucoma type)
* Brimonidine (selective alpha 2 adrenergic agonist): neuroprotection effect by suppression of aqueous humor production and increasement of uveoscleral outflow
* Timolol (non selective beta blocker): suppression effect of aqueous humor production
* Combigan (fixed combination of brimonidine \& timolol): more lowering effect of intraocular pressure and enhancing the compliance of glaucoma patients

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* baseline IOP under 22 mmHg,both anterior chamber angle \> Grade 3\~4 by Shaffer grading system

Exclusion Criteria:

* IOP over 22 mmHg by Goldmann applanation tonometer
* other types of glaucoma except open angle
* other IOP lowering treatment
* chronic or recurrent Hx. of ocular inflammation
* using contact lens
* any other ocular disease that could affect visual field examination (diabetic retinopathy, macular disease, uveitis, scleritis, optic neuritis, anterior ischemic optic neuropathy)
* intraocular or glaucoma surgery within 6 months
* Hx. of allergic reaction to timolol or brimonidine
* bronchial asthma
* moderate to severe chronic obstructive pulmonary disease
* heart failure
* 2\~3 degree A-V block,
* MAO inhibitor use
* anti depressant use
* untreated pheochromocytoma
* pregnant
The Effects of Diet on Small Non-coding RNA I Sperm Cells and the Possible Effects on Reproductive Success: Diet Intervention Effects on Sperm

In this study, patients with infertility treated with IVF at the Center of Reproductive Medicine in Linköping, Sweden, will receive recipes and food according to Nordic dietary guidelines. The purpose is to investigate whether a short diet intervention is sufficient to improve sperm quality and shift the small non-coding RNA profile. In our previous study sperm showed rapid response to diet.

This study is a randomized controlled trial recruiting males seeking IVF treatment with their female partner at the Center for Reproductive Medicine in Linkoping, Sweden. Men will be randomized to a control group or diet intervention group.

The intervention group will receive groceries with planned recipes during the hormonal treatment period for the woman (11-14 days) before IVF. The meal plan will be according to the Nordic dietary guidelines and individualized to match total energy expenditure.

The male partner must accept to participate in the diet intervention in order to be included and the female partner can choose to participate in the diet intervention but it is optional. Sperm samples will be collected before the start of hormonal treatment and on ovum pick-up day. Weight will be measured before and after the intervention. Sperm samples will be processed as standard practice at the fertility clinic. Sperm samples will be used for molecular analysis, such as small RNA sequencing.

Eligibility Criteria:
Inclusion Criteria:

* Male (biological) partner in infertile couple, scheduled for first IVF treatment
* Mature sperm cells in semen
* Able to speak and read Swedish
* Omnivore
* Will refrain from nicotine and alcohol during intervention
* Sperm sampled provided no more than 3 weeks before intervention start

Exclusion Criteria:

* Former or present malignant disease
* Former radiotherapy in pelvic area
* Former chemotherapy
* Known genetic/chromosomal disorder
* Food allergy
Collaborative Care for the Detection and Management of Depression Among Adults Receiving Antiretroviral Therapy in South Africa

With increasing access to antiretroviral therapy (ART) in South Africa, HIV has transitioned from a terminal illness to a long-term condition. It is likely to be accompanied by higher levels of disability and other chronic non-communicable diseases, resulting from the HIV itself, as well as adverse effects of medication. This requires an expansion of the purview of HIV care beyond direct HIV clinical care to also include a more comprehensive and integrated package of treatment and care for physical and mental conditions and their consequences. COBALT is a pragmatic cluster randomized controlled trial (RCT) in public sector primary care clinics in the North West Province of SA. It will assess mental health and HIV outcomes for depressed adults receiving ART by measuring the real-world effectiveness of a facility-based stepped care intervention combining depression case detection by non-physician clinicians with group counselling intervention delivered by lay-health workers.


Eligibility Criteria:
Inclusion Criteria:

Clinics:

1) 40 nurse-led primary care clinics providing ART in the Dr Kenneth Kaunda and Bojonala districts of the North West Province, South Africa

Patients:

1. Age ≥ 18 years and
2. Receiving ART at the time of enrollment and
3. Depressive symptoms, as indicated by a total score of 9 or more on the PHQ-9 and
4. Planning to reside in the area for the next year and
5. Capable of actively engaging in an interviewer-administered questionnaire at the time of recruitment, six and twelve months later and
6. Written consent to participate in the study

Exclusion Criteria:

Clinics:

1) Clinics which participate in the formative research and piloting of the intervention

Patients:

1) Inability to meet the above inclusion criteria
Skin Protectant Properties of Omeza Collagen Matrix on Damaged Skin

Single-blind within subject comparison study conducted to investigate the skin protectant properties of Omeza Collagen Matrix on damaged skin

This study was conducted in 22 healthy subjects to determine the skin protectant and anti-inflammatory properties of the test product.

For the skin protectant assay the test article was applied to the forearm and covered with gauze for 10 minutes before assessment of irritation and TEWL readings.

An inflammatory skin response was induced by a SLS solution 24 hours prior to application of the test article. The test article was applied for 10 minutes at the site of inflammation. The test site was then graded for irritation and TEWL readings.

Eligibility Criteria:
Inclusion Criteria:

* Subject is a healthy male or female, aged 18 years or older.
* Subject has signed a written Informed Consent.

Exclusion Criteria:

* Pregnancy or lactation.
* Inadequate precaution or procedure to prevent pregnancy (women of child bearing potential only).
* A current skin disease of any type at the test site (e.g. eczema, psoriasis)
* Heavy alcohol consumption in the opinion of the investigator.
* A fever in the last 12 hours, prior to the initial patch application.
* Significant past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease, which in the opinion of the Investigator would compromise the safety of the subject.
* History of malignant disease.
* Insulin dependent or non-insulin dependent diabetes.
* Concurrent medication likely to affect the response to the test articles or confuse the results of the study, i.e. routine high dosage use of antiinflammatory drugs (aspirin, ibuprofen, corticosteroids).
* Known sensitivity to the treatment solutions or their constituents including patch materials.
* Sensitisation or questionable sensitisation in a Repeat Insult Patch Test.
* Use of self-tanning lotion on the test area, one week previous to the start of the study.
Compliance in the Physicians' Health Study

To evaluate the relationships of compliance in taking aspirin or aspirin placebo with the risk of major cardiovascular endpoints, using data collected in the Physicians' Health Study.

BACKGROUND:

The Physicians' Health Study was a randomized, double-blind placebo-controlled primary prevention trial designed to test whether 325 mg aspirin every other day reduced risks of cardiovascular disease and whether 50 mg beta-carotene on alternate days decreased cancer incidence among 22,071 male U.S. physicians, aged 40-84 years in 1982. Compliance with study pills, the use of non-study aspirin and platelet active drugs, specific side effects of aspirin, the incidence of conditions indicating aspirin use, and study outcomes were assessed at six month intervals during the first year and annually thereafter. The blinded aspirin component of the trial was terminated early and participants were unblinded on January 25, 1988, due to the emergence of a statistically extreme benefit of aspirin on both fatal and nonfatal myocardial infarction, as well as the extraordinarily low cardiovascular mortality rates among study participants.

DESIGN NARRATIVE:

Separate dose-response relationships were estimated in the aspirin and in the placebo group to determine whether compliance in the placebo group was associated with lower risk, as had been found in some previous trials. Rates of cardiovascular endpoints in the placebo group relative to the aspirin group were adjusted for time-varying compliance with study tablets, and the use of non-study aspirin and platelet active drugs. In addition, baseline characteristics of the population and longitudinal assessment of side-effects and new conditions suggesting aspirin therapy were used as predictors of compliance in taking study pills separately in the aspirin and placebo groups. Similar longitudinal analyses determined predictors of the use of non-study aspirin and platelet active drugs. The analyses were intended to supplement the already published intent-to-treat analyses. They provided observational evidence concerning dose of aspirin and the risks of major cardiovascular endpoints. Examining modification of the aspirin effect in reducing risk of myocardial infarction according to level of compliance aided in the generalizability of results to less motivated populations. Evaluating determinants of good study compliance should be of benefit to future large scale clinical trials.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Muscle Loss and Fatigue as a Consequence of Radiotherapy

This study examines the extent of systemic muscle loss and the degree of fatigue experienced by breast cancer patients undergoing radiotherapy. This study seeks to identify whether muscle loss occurs outside the radiation fields and if muscle loss is correlated with the degree of fatigue.

This study uses a patient reported survey to assess fatigue prior to radiotherapy for breast cancer. Fatigue is measured again at the completion of radiation treatments and at one and three months following completion of radiation.

Muscle measurements are made outside the treatment area using ct scans prior to radiation treatment, at the completion of radiation treatment and at one and three months after radiation treatment. The degree of fatigue and changes in muscle will be assessed. Changes will be correlated to determine if muscle loss contributes to fatigue.

Eligibility Criteria:
Inclusion Criteria:

1. Women Age ≥ 18 years
2. Non-metastatic breast cancer for which post-operative radiation treatment has been recommended as standard of care
3. Able to provide informed consent
4. Able to complete the Brief Fatigue Inventory questionnaire -

Exclusion Criteria:

1. Pregnant
2. Inability to meet eligibility requirements -
Vital Signs Blood Pressure Trial

The purpose of this study is collect subject vitals with a blood pressure cuff, electrocardiogram (ECG), and photoplethysmogram (PPG). This data can then be used to develop a reliable, accurate, noninvasive, and continuous blood pressure monitoring device.


Eligibility Criteria:
Inclusion Criteria:

* Age \>17 and \<65 years
* BMI \>20 and \<35

Exclusion Criteria:

* Age \<18 or \>64
* BMI \<20 or \>35
* Pregnancy
Factors and Prognosis of Obstructive Pyelonephritis Patients

Acute obstructive pyelonephritis is a condition with a high risk of complications and may require admission to the intensive care unit.

Most of the available data on this condition comes from small, retrospective, single-centre series.

To date, no large-scale study has examined the factors associated with the prognosis of patients admitted to intensive care for acute obstructive pyelonephritis.

The aim of this study is to describe the population and prognosis of patients admitted to the intensive care unit for the management of acute obstructive pyelonephritis, and to identify factors associated with a poor prognosis in these patients.

The retrospective and multicenter study consists of a retrospective and pseudonymous collection of data from medical reports of patients treated, over the period 2015-2022, in each intensive care unit agreeing to participate, .

Investigators from each participating center will be responsible for screening on all hospitalized patients over the period 2015-2022. Patients who have been hospitalized for the management of acute obstructive pyelonephritis will be included, in the absence of non-inclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Hospitalized in intensive care for management of acute obstructive pyelonephritis
* Patients affiliated to a Social Security System

Exclusion Criteria:

* Pregnancy
* Opposition to data use
* Persons under legal protection (curatorship, guardianship), legal safeguards
Elongation Longitudinaux Avec Decoaption Osteo-Articulaire (ELDOA) in Lumbar Disc Protrusion

The aim of this randomized controlled trial will be to determine the effectiveness of ELDOA for treating lumbar disc protrusion. Two randomized groups of patients with lumbar disc protrusion will be treated with conservative physical therapy and the experimental group will be given ELDOA, in addition. Both, male and female patients meeting the inclusion criteria will be included. Patients having concurrent malignancy, infection, trauma or any bony deformity will be excluded

The study is aimed at determining the effects of ELDOA in treating disc protrusion at lumbar region and is being conducted in Max Rehab \& Physical Therapy Centre Islamabad and Pakistan Railway General Hospital, Rawalpindi (March 2019-June 2019). Sample size of the study is 34 with confidence interval of 95% and power of 0.8. 30 patients were screened and 29 were included in the study on the basis of inclusion criteria. Sealed envelope contained total 34 questionnaires, 17 for each group. Patients were allocated randomly on the basis of group mentioned on the Performa. Similar conservative rehabilitation protocol was designed for both control and experimental group except for experimental group had ELDOA Exercises in addition. Patients were examined at 1st visit before administration of any treatment and at 4th visit which was also the last one (after completing 4 sessions at alternate days). Baseline evaluation for demographics and symptomatology was taken. Self-reported questionnaire, ODI, NPRS, lumbar ROM and SLR were recorded at first and fourth visit for comparison. 26 patients completed the study while 1 patient from control group and 2 patients from experiment group were lost to follow up and were considered drop outs.

Eligibility Criteria:
Inclusion Criteria:

* Limited ROM (hip/lumbar spine)
* Pain more than 3 on NPRS
* Pain ≥ 3 months

Exclusion Criteria:

* Recurrent disc protrusion
* Spondylolisthesis
* Spondylosis
* Malignancy
* Infection
* Trauma
* Marked bony deformities
New Health Devices to Improve Adherence to Physical Activity in Overweight Inactive Adults

The purpose of this study is to test in overweight and inactive adults whether the new PAI eHealh APP leads to better adherence to a physical activity regimen than the wearable step counter App from the market leader FitBit, and to evaluate if improved adherence will be reflected in a better cardiovascular profile in this group.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index \> 25
* self reported exercise one time or less per week

Exclusion Criteria:

* inability to use a SmartPhone
* illness or disabilities that preclude or hinder completion of the study
* cancer that makes participation impossible or exercise contraindicated (considered individually, in consultation with physician)
* test results indicating that study participation is unsafe
* participation in other studies conflicting with participation in this study
* symptomatic valvular, hypertrophic cardiomyopathy, unstable angina, primary pulmonary hypertension, uncontrolled hypertension, heart failure or sever arrhythmia
* diagnosed dementia
* chronic communicable infectious diseases
* Bariatric surgery
* Medication for thyroid disease, diabetes, blood pressure or lipid lowering medication