cyrilzakka/clinical-trials huggingface dataset:
Healthy Outcomes for Muscle with Exercise in T1D

Over 300,000 people in Canada suffer from Type 1 Diabetes (T1D), a chronic condition whose incidence rate has been increasing in Canada every year by 5.1% (higher than the global average). While exogenous insulin injections allow those with T1D to live, it is not a cure, and those with T1D develop severe complications (kidney failure, cardiovascular disease). Strategies to regress the development of these complications, minimize healthcare system burden, and save the lives of Canadians are urgently needed.

Undertaking regular exercise is an obvious strategy for those with T1D and has many well-established health benefits. Despite these benefits, adults with T1D exercise less frequently due to fear of severe hypoglycemia and a lack of knowledge of effective exercise strategies. Adding to this complexity, the investigators have recently shown that males and females elicit differential impairments in skeletal muscle metabolism in response to T1D. These differences may extend to the peripheral microvasculature and may lead to sexual dimorphism in the health benefits of exercise for those with T1D. Ultimately, developing a healthy muscle mass, including microvasculature, will help mitigate dysglycemic and dyslipidemic fluctuations and improve insulin sensitivity.

The overarching purpose of this proposed study is to determine the impact of T1D on human skeletal muscle and its microvasculature over the lifespan in males and females, and its responses to exercise training and detraining.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18-30 or 45-65
* Sedentary or recreationally active, as defined by self-reported activity levels below the recommended 150-minute minimum of moderate-to-vigorous intensity physical activity per week

Exclusion Criteria:

* Chronic use of anti-inflammatory, glucocorticoid, or other pain-relief medication
* History of daily cannabis, tobacco, or nicotine use within six months of study initiation
* BMI \>30kg/m2
* Prediabetes
* Type 2 diabetes
* Health conditions that put the subject at risk to participate in exercise during this study
* Atypical or Grade 2b diabetic sensorimotor polyneuropathy
* More than one lifetime event of hospitalization for diabetic ketoacidosis
Chinese Research Group of Gallbladder Cancer

The Chinese Research Group of Gallbladder Cancer (CRGGC) is a retrospective multicenter registry cohort, collecting electronic medical records of patients diagnosed with gallbladder cancer from hospitals in collaboration.

The objectives of the CRGGC are as follows:

1. To study the current diagnosis and treatment of gallbladder cancer in China.
2. To clarify the prognostic role of debated risk factors associated with gallbladder cancer.
3. To improve the accurate staging of gallbladder cancer.
4. To standardize the treatment with gallbladder cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients with at least clinical diagnosis of gallbladder cancer, including C23.9 and part of C24.0 (cystic duct cancer).
* Patients with accessible electronic medical record

Exclusion Criteria:

* Patients with undetermined primary site of cancer.
The Evaluation of a New Sleep Algorithm

A new device is being developed to screen for sleep-breathing disorders. Within this device is a new software algorithm which will determine sleep/wake states. The aim of this study is to evaluate the performance of this new algorithm. This prototype will be compared against a commercially available device which monitors sleep/wake patterns. Volunteers will be asked to wear the prototype and comparative devices for 1-2 nights. The data from both devices will be downloaded after the completion of the study and analysis wil be performed to compare the two recordings.


Eligibility Criteria:
Inclusion Criteria:

* =\> 18yrs old
* can read and write English
* Provide informed written consent

Exclusion Criteria:

* Unable to participate for the full duration of the study
* An individual who is deemed unsuitable to participate in the opinion of the investigator
Evaluating Attitudes Towards Organ Donation in the United States on MTurk

The study is conducted to investigate the effects of priming different cultural orientations on participants' decisions on whether to donate their organs, in an opt-out donation system scenario where the default is a presumed consent on the part of the individual.

Participants complete a survey where they respond to scales measuring their baseline cultural and power distance orientations, and answer questions on their demographics such as gender, race, employment etc.

24 hours later, participants fill in a 2nd survey where they are instructed to complete 1 out of 2 possible priming tasks. The possible tasks consist of an Individualistic priming condition and a Collectivistic priming condition; both tasks require participants to answer 3 statements each to 3 questions regarding the self or their social group. Participants then indicate their choice on whether to donate their organs (default or opt-out), rate their confidence regarding their choice and complete the same scales measuring their cultural and power distance orientations.

Eligibility Criteria:
Inclusion Criteria:

* Aged 21 and above
* Lives in the United States of America

Exclusion Criteria:

* Below age 21
* Does not live in the United States of America
Rheopheresis for Raynaud's and Digital Ulcers in Systemic Sclerosis

In this feasibility study, we aim to explore therapeutic Rheopheresis (RheoP) as a novel treatment option for SSc-associated Raynaud's phenomenon and/or digital ulcers and compare it to the standard of care treatment (intravenous iloprost. RheoP has been used for RP/DU with some success in observational studies, nevertheless, the optimal treatment modality, duration, or frequency of RheoP (and PEX in general) in SSc has not been established as of yet.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients fulfilling ACR/EULAR classification criteria for SSc
2. Presence of RP with or without DU
3. Failure of at least one standard of care treatment (CCB or iloprost) for at least three months
4. RCS \> 4
5. Possibility to obtain venous access (either through a peripherally or centrally inserted catheter)

Exclusion Criteria:

1. Significant anemia (\<8 g/dL)
2. Clinically relevant hemorrhagic diathesis or coagulopathy
3. Diabetes mellitus
4. Serious acute or chronic kidney (eGFR\<30 ml/min/1.73m2) or liver failure
5. Hypotension with systolic blood pressure \<100 mmHg
6. Chronic viral infections (HIV, Hepatitis B, C)
7. Epilepsia, psychosis, dementia, or other relevant neurologic condition precluding the conduct of plasmapheresis
8. Malignant disease or any other condition with life expectancy \<12 months
9. Known history of alcohol or drug abuse
10. Long-term serious tobacco abuse with documented severe vascular disease (Fontaine \>III).
11. Severe hyperlipoproteinemia, defined as a significant elevation of Lp(a) or LDL cholesterol despite standard doses of medical therapy
Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency

The purpose of this phase II trial is to determine the efficacy and safety of testosterone replacement therapy (TRT) in improving the symptoms of androgen deficiency and health-related quality of life in men with prostate cancer who have undergone radical prostatectomy.

The overall objective is to conduct a proof-of-concept double-blind, placebo-controlled, parallel group, randomized trial to determine the efficacy and safety of testosterone replacement therapy (TRT) in improving the symptoms of androgen deficiency (sexual symptoms, low energy, and physical dysfunction) and overall health-related quality of life in men with prostate cancer who have undergone radical prostatectomy for organ-localized disease (pT2,N0,M0), Gleason score \< 7 (3+4), who have undetectable PSA (\<0.1 ng/mL using a sensitive PSA assay) for \> 2 years after radical prostatectomy, and who have androgen deficiency.

Eligibility Criteria:
Inclusion Criteria:

Men with prostate cancer, who have Stage pT2, N0, M0 lesions (confined to the gland); Combined Gleason score of 7 (3+4 elements) or less; Preoperative PSA less than 10 ng/ml; Stable and undetectable PSA level (PSA less than 0.1 ng/mL using an assay that has a functional sensitivity of 0.1 ng/mL) for at least two years after radical prostatectomy.

* Age: 40 years and older
* Presence of symptoms related to sexual dysfunction, fatigue/low vitality, or physical dysfunction.
* An average of two fasting, early morning serum testosterone levels, measured by LC-MS/MS, less than 275 mg/dL and/or free testosterone by equilibrium dialysis \<60 pg/mL. middle-aged and older men with mean testosterone levels \> 300 ng/dL.
* Ability and willingness to provide informed consent

Exclusion Criteria:

* Men who have undergone radiation therapy
* Men receiving androgen deprivation therapy will be excluded.
* Hemoglobin \<10 g/dL or \>16.5 g/dL
* Severe untreated sleep apnea
* Allergy to sesame oil
* Uncontrolled heart failure
* Myocardial infarction, acute coronary syndrome, revascularization surgery, or stroke within 3 months
* Serum creatinine \>2.5 mg/dL; ALT 3x upper limit of normal;
* Hemoglobin A1c \>7.5% or diabetes requiring insulin therapy
* Body mass index (BMI) \>40 kg/m2
* Untreated depression. Subjects with depression who have been on stable anti-depressant medication, or undergoing CBT for more than three months are eligible.
* Men with axis I psychiatric disorder, such as schizophrenia, will be excluded.
* Subjects who have used the following medications within the past 6 months: testosterone, DHEA, estrogens, GnRH analogs, antiandrogens, spironolactone, ketoconazole, rhGH, megestrol acetate, prednisone 20 mg daily or equivalent doses of other glucocorticoids for more than two weeks
Allosure in Simultaneous Pancreas Kidney Transplant

This study will observe donor derived cell free DNA percentages (via the Allosure test) in combined kidney-pancreas transplant recipients to establish both stable and dysfunctional Allosure assay levels

Simultaneous kidney-pancreas transplantation is the optimal treatment for select patients with type 1 diabetes and kidney failure. Limited biomarkers are utilized to monitor the health of the allografts. For kidney transplantation serum creatinine remains the most commonly monitored biomarker; for the pancreas allograft blood glucose and serum amylase and lipase are measured. However, these biomarkers are imprecise and non-specific for rejection.

In kidney transplantation cell free donor derived DNA at of value of \>1% has emerged as an effective immune monitoring tool as a marker for renal allograft rejection and injury. Thus far, a discriminatory donor derived cell free DNA value for a stable and rejecting allografts has not been established for recipients of combined kidney-pancreas transplants.

Study aim will be to help establish a normal range of donor derived cell free DNA in stable kidney-pancreas graft function in combined kidney pancreas transplant recipients while determining changes in cell free DNA in kidney-pancreas recipients with biopsy proven allograft rejection.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Kidney-pancreas transplant recipients
* Patient must have stable creatine, lipase, amylase for at least a two month span after transplant OR patient must receive a biopsy within one year post transplant

Exclusion Criteria:

* Presence of non-renal or pancreas transplanted organ
* Patient is not enrolled within 1 year after transplant
Treating Depression and Anxiety in the Cardiac Rehabilitation Pathway

Cardiac rehabilitation (CR) services aim to improve heart disease patients' health and quality of life, and reduce the risk of further cardiac events. Depression and anxiety (distress) are common among CR patients: 37% of patents have significant anxiety and/or depressive symptoms. Distressed patients are at greater risk of death, further cardiac events and poorer quality of life than those without distress and they use more healthcare. Available drug and psychological treatments have only small effects on distress and quality of life, and no effects on physical health. Therefore, it is essential that more effective treatments for depression and anxiety are integrated into CR services. Extensive evidence shows that a particular style of thinking dominated by rumination (dwelling on the past) and worry maintains emotional distress. A psychological intervention (metacognitive therapy) that reduces this style of thinking alleviates depression and anxiety in mental health settings. The investigators aim to conduct a pilot trial of the group intervention and in work stream 2 the investigators will undertake a full-scale trial to evaluate whether adding the group intervention to standard CR is more effective at alleviating anxiety and depression than standard CR alone.


Eligibility Criteria:
Inclusion Criteria:

* Heart disease patients referred to CR with: Acute coronary syndrome
* Following revascularisation; stable heart failure
* Stable angina, implanted cardioverter defibrillators
* Heart valve repair/replacement
* Heart transplantation and ventricular assist devices
* Adult congenital heart disease
* Must have a score of 8 or more on either the depression or anxiety subscale of the HADS
* Competent level of English language skills

Exclusion Criteria:

* Cognitive impairment which precludes informed consent/ability to participate
* Acute suicidality
* Active psychotic disorders
* Current drug/alcohol abuse
* Concurrent psychological intervention for emotional distress
* Antidepressant or anxiolytic medication initiated in previous 8 weeks
* Life expectancy of less than 12 months
Ambu AuraGain Laryngeal Mask Airway and I-gel in Children

Children aged below 7 years are randomly assigned to AuraGain Group or I-gel group. After anesthetic induction, AuraGain or I-gel is inserted and mechanical ventilation is started. Oropharyngeal leak pressure, peak inspiratory pressure, success rate for insertion, ease for insertion, ease for gastric tube insertion and fiberoptic bronchoscopic views will be compared between two groups.


Eligibility Criteria:
Inclusion Criteria:

* Children \< 7 years old who scheduled for general anesthesia using supraglottic airway

Exclusion Criteria:

* Children who require tracheal intubation
* Emergency operation without nil per os
* History of C-spine surgery or disease
* History of Esophageal disease or surgery
Metformin Use and Clinical Pregnancy Rate in Women With Unexplained Infertility

The aim of this study is to asses the effect of metformin on clinical pregnancy rate in women with unexplained infertility (randomized controlled trial).

This study will be conducted in infertility clinic,Ain Shams university maternity hospital,170 women with unexplained infertility will be enrolled in this study.

Statistical analysis of the data will be performed .

Metformin is usually used with induction regimen in patients with PCOS as it improves ovulation rate by direct effect on ovarian tissue,Metformin will be used in combination with clomiphene citrate in women with unexplained infertility with previous failed cycle to asses its efficacy on clinical pregnancy rate.

Study will be conducted in infertility clinic,Ain Shams university maternity hospital.Study population comprises women with unexplained infertility aged 20-35 years with total sample size of 170 who willbe randomized into two groups with 85 women in each group.

Group A:is case group who will receive metformin plus clomiphene citrate. Group B:is control group who will receive clomiphene citrate plus placebo. Metformin will be started at time of booking and will be continued till pregnancy is confirmed in a dose of 850 mg twice daily in form of tablet.

Vaginal ultrasound is done for all in day 2 to exclude presence of ovarian cyst and to identify normal appearance of ovaries,then folliculometry on day 9 followed by serial folliculometry every other day till reaching dominant follicle 18 mm or more where HCG intramuscular injection will be given in a dose of 10000 iu .

serum pregnancy test will be done after 16 days. Transvaginal ulterasound will be done on day 35.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-35 years old.
* BMI 20-\<30
* FSH 12 IU/L or less
* Normal transvaginal ulterasound(normal uterus and ovaries with no congenital anomalies).
* Patent fallopian tubes assesd by hysterosalpingogram or laparoscopy.
* Normal semen analysis.
* Infertile women with history of previous failed induction cycle.

Exclusion Criteria:

* Women younger than 20 or elder than 35 years old.
* Women with BMI equal to or more than 30.
* Uncorrected congenital or acquired uterine anomaly.
* Other causes of infertility rather than unexplained infertility.
* Patient with Diabetes Mellitus.
Application of Transcranial Direct Current Stimulation (tDCS) for Gait Function Improvement of Parkinson's Disease Patient

The purpose of this study was to investigate the effect of simultaneous application of transcranial direct current stimulation (tDCS) and treadmill gait training for gait function recovery in Parkinson's disease patients with gait impairment.


Eligibility Criteria:
Inclusion Criteria:

* Age: 50 - 75 years
* Modified Hoehn and Yahr stages 1 to 4

Exclusion Criteria:

* Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
* Difficult to understand experimental tasks because of extremely severe cognitive impairment (Korean-Mini-Mental State Examination, K-MMSE≤10)
* History of psychiatric disease
* Implanted objects that would contraindicate tDCS
Functional Knee Phenotypes of Patients Operated on for Total Knee Arthroplasty

The aim of this study was to analyze the coronal alignment of a large population of patients undergoing total knee arthroplasty using a modern classification of the knee phenotypes found in a population of non-osteoarthritic patients.

Methods Five hundred and four navigated total knee arthroplasties will be analyzed. The following angles will be measured with a computer image free navigation system: medial femorotibial mechanical angle without stress and with maximum manual stress to reduce deformation, and medial distal femoral mechanical angle. The native medial distal femoral and medial proximal tibial angles will be calculated. The data will be analyzed as numerical and categorical data. These data will be then compared with those published in a non-arthritic population, considered as a control group.

The main criterion will be the percentage of subjects with normal overall coronal alignment, defined by the association of a normal native medial distal femoral angle and a normal native medial proximal tibial angle. The secondary criteria will be the percentages of subjects with normal medial femorotibial mechanical angle, normal native medial distal femoral angle and normal native medial proximal tibial angle. The influence of gender on primary and secondary criteria in the study group will be analyzed. The most frequent phenotypes in the study group will be identified.

Eligibility Criteria:
Inclusion criteria:

* Patient aged ≥ 18 years
* Patient operated between 01/01/2011 to 02/28/2021 by two experienced surgeons of a total knee prosthesis using a navigation system without image (OrthoPilot ®, Aesculap, Tuttlingen, FRG) allowing to measure during the intervention the anatomical parameters of the subject before implantation;
* Records including a complete intraoperative anatomical analysis;
* Subject who has not expressed his opposition, after being informed, to the reuse of his data for the purposes of this research.

Exclusion criteria:

* Subject who expressed their opposition to participating in the study
* Impossibility of giving the subject informed information (difficulties in understanding the subject, etc.)
* Incomplete or absent anatomical analysis
* Subject under guardianship, curatorship or safeguard of justice
Aesculus Hippocastanum L. on Fontan Circulation

Patients after the Fontan operation at a single institution will be randomized to receive a standardized extract of Aesculus hippocastanum L. (horse chestnut) or placebo for 4 months in a crossover clinical trial. The primary outcome will be the mesenteric artery resistance measured by Dopple sonography.


Eligibility Criteria:
Inclusion Criteria:

* Underwent Fontan surgery

Exclusion Criteria:

* Severe adverse reaction
* Personal or parental request
A Study to Investigate the Pharmacokinetics and ECG Effects of Linaprazan Glurate

This is a Phase I, single-center, double blind, placebo-controlled, parallel-group, randomized study designed to evaluate the PK, cardiodynamic ECG effects, safety, and tolerability of 2 single ascending oral doses of linaprazan glurate. The study will explore the PK properties of linaprazan glurate and linaprazan as well as the cardiodynamic ECG effects, safety, and tolerability after the administration of single doses (300 mg, 600 mg, 200 mg and a final dose level of maximum 400 mg) of linaprazan glurate, using 25 mg base formulation (300 mg and 600 mg doses) and 25 mg and 100 mg HCl formulation (200 mg and final dose level of maximum 400 mg) oral tablets.


Eligibility Criteria:
Main inclusion Criteria:

1. Willing and able to give written informed consent for participation in the study.
2. Healthy male or female aged 18 to 65 years
3. Body mass index ≥18.5 and ≤35.0 kg/m2.
4. Prospective subjects, as well as their partners, must agree to contraception requirements

Main exclusion criteria:

1. Female subjects of childbearing potential unless they agree to use highly effective methods of contraception (failure rate of \<1%) from 2 weeks prior to dosing until the end-of-study visit.
2. Male subjects with a partner of childbearing potential, unless they agree to use method of contraception from 2 weeks prior to dosing until the end-of-study visit.History of or current clinically significant disease as defined in the protocol
3. History of or current clinically significant disease as defined in the protocol.
4. History of GERD, significant acid reflux.
5. Subjects who are pregnant, currently breastfeeding, or intend to become pregnant (female subjects) or father a child (male subjects) during the course of the study (i.e., from screening to end of study visit).