cyrilzakka/clinical-trials huggingface dataset:
Genomics of Chronic Renal Allograft Rejection (The GoCAR Study)

Doctors have had success preventing certain types of kidney transplant rejection by suppressing the immune system. However, an individual's genetic make-up and the strength of an immune response to a transplant may also determine whether a transplanted organ is rejected. The purpose of this study is to look at the genetic profile and immune response of people who have had kidney transplants and to correlate the findings with kidney transplant rejection episodes. Donor genetic profiles will also be studied and correlated with the recipient's information.

New immunosuppressive drugs have improved short-term transplant survival but have not affected long-term transplant survival. Rejection is caused by both immunological and non-immunological factors from both the donor and the recipient. Although the exact cause of chronic rejection is not known, it is associated with the presence of C4d, a degradation product of the antibody response cascade, and the presence of circulating donor-specific antibodies (DSAs). The purpose of this study is to determine the role of cell- and antibody-mediated responses in chronic rejection of transplants, to determine the gene expression profile associated with the development of chronic rejection, and to determine whether variants of specific genes cause susceptibility to rejection.

This is an observational study of people who will be receiving kidney transplants and participants will be followed for 2 years. Study visits for kidney transplant recipients will occur at study entry and at months 3, 6, 12, 18, and 24 after transplant. At these visits, adverse event assessment, rejection assessment, medication history questionnaire, and blood collection will occur. At some visits, a physical exam and a kidney biopsy will occur. Blood will also be collected from living kidney donors at the time of donation if both donor and recipient agree to be in the study. This study will be take place at 4 clinical sites: Mount Sinai School of Medicine, University of Wisconsin-Madison, Westmead Hospital, and Northwestern Memorial Hospital. Brigham and Women's Hospital and Massachusetts General Hospital will also participate in the study as central laboratories.

Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant candidates from living or deceased donors
* Male or female, ages 18-75 years
* Subject must be able to understand and provide written informed consent
* Living Donors - Recipient also consents to participate in the study

Exclusion Criteria:

* Presence of Donor Specific Antibodies in living donor recipients prior to transplantation OR positive cross match according to site-specific technique in cadaveric donor recipients
* Recipients of multiple organ transplants, with the exception of kidney/pancreas transplants.
* Inability or unwillingness to comply with the study protocol.
Tai Chi Quan Improving Biochemistry and Quality of Life in Type 2 Diabetes

In this study, the hypothesis that the 12-week Tai Chi Quan training would have better control of blood sugar, biochemistry profile, and also better quality of life and activity of autonomic nerve system (ANS). The subjects were randomize assigned to either Tai Chi group or control group. The outcome measures before and after 12-week intervention include basic demographic characteristics, HbA1c, fasting blood glucose(FBG), triglycerides (TG), high and low density lipoprotein (HDL, LDL), creatinine(Cr), eGFR, GPT, ACR, quality of life, and activity of automatic nerve system.

In this study, the hypothesis that the 12-week Tai Chi Quan training would have better control of blood sugar, biochemistry index, and also better quality of life and activity of automatic nerve system. In the study, type 2 diabetes mellitus(T2DM) patients will be recruited as subjects. The subjects were randomized to either Tai Chi group or control group. Tai Chi group would take Tai Chi Quan training for 1hr, twice a week for 12 weeks. There were 10-minute warm-up, 40-minute Tai Chi lesson, and 10-minute cool-down exercise in the training. In this study, the 1st section of Yang style 108 form is chosen for the experiment group. Both group were given diabetic patients care education and the exercise recording book for encouraging the daily exercise habits. The outcome measures before and after 12-week intervention include basic demographic characteristics, HbA1c, fasting blood glucose, triglycerides, high and low density lipid, creatinine, eGFR, GPT, ACR, quality of life, and activity of automatic nerve system.

Eligibility Criteria:
Inclusion Criteria:

* 40\~80 years old
* Diagnosed type 2 diabetes mellitus, and without changing dietary pattern and medical treatment for blood glucose or blood lipid.
* Consciousness clear and is voluntary to attend the project and with the agreement.
* The functional movement ability is independent

Exclusion Criteria:

* Pregnant or plan to be pregnant in six months, and breast feeding.
* Severe complication in six months such as myocardial infarction, stroke, severe traumatic injury, major surgery. Other diseases evaluated by the doctor that are not suitable for the project.
* Evaluated that the compliance for the intervention is not appropriate.
* The blood glucose \> 300mg/dl and unable to do vigorous exercise.
Telehealth Delivery (Tele-B6)

The research team has developed an interventional group program for young men living with HIV and will be adapting it for telehealth delivery. The purpose of the study is to determine whether or not this program can help improve social connections and the health of young men in online delivery and evaluate its potential for implementation in a community setting. The study has three phases: (1) engaging a community advisory board to create and adapt the intervention for online delivery, (2) a randomized clinical trial of the online intervention, and (3) evaluation of the program for community implementation with our partner organization. Participants in the second phase of the study will meet with a study team member to discuss the research process and provide informed consent. The community organization employees will provide consent online prior to completion of a survey and indicate whether they consent to be contacted further for in-depth interviews.

Subjects will participate in synchronous, online discussion sessions via videoconference for two hours per week over a six-week period. Sessions will include engaging educational components and interactive activities including discussions of case scenarios and sharing of personal experiences where desired. At the end of each videoconference session, participants will be asked to complete a brief session evaluation form in which they will rate the content, facilitation, and overall experience for the week. The long-term goal is to improve engagement across the HIV continuum of care (HIV-CoC) by enhancing individual- and community-level resilience processes among young Black gay, bisexual and other men who have sex with men (YB-GBMSM) living with HIV. To this end, the research team has used community-based participatory research methods to develop Brothers Building Brothers by Breaking Barriers (B6), a novel group-level intervention designed to affirm intersectional identities and augment social capital among YB-GBMSM. The goal of this current study is to adapt and pilot B6 for telehealth delivery (creating tele-B6) within the context of an established community-based organization (CBO), as a strategy for enhancing feasibility and scalability prior to a larger efficacy trial.

Eligibility Criteria:
Inclusion Criteria:

* Black race, inclusive of multiracial identities; male gender, inclusive of transgender men;
* self-identification as gay, bisexual, or another non-heterosexual orientation, and/or any history of consensual anal or oral sex with men;
* HIV-positive serostatus;
* age 18-29 years inclusive;
* residence in the Atlanta Metropolitan Statistical Area;
* available and interested to meet for two hours weekly over a six-week period.

Exclusion Criteria:

* Age \< 18 years or \> 30 years
* Unwilling or unable to provide written informed consent
* Enrollment in one phase of the study is an exclusion criterion for enrollment in other phases
Subjective and Objective Results With CI Electrode Types

Background The authors' aim was to compare the influence of various electrode designs on selected objective and subjective clinical outcomes for cochlear implant recipients using the same model of receiver-stimulator, Cochlear™ Nucleus® Profile Series and sound processor.

Methods A multicenter study with subjects with profound sensorineural hearing loss, who were implanted and followed up in two tertiary centers. A total of 54 ears were implanted with Cochlear™ Nucleus® CI532, 51 with Cochlear™ Nucleus® CI522 and 54 with the Cochlear™ Nucleus® CI512. Implant loss and intraoperative electrophysiological tests (electrically evoked stapedial reflex threshold \[ESRT\], neural response telemetry threshold \[T-NRT\] and impedance), postoperative data (C-level, T-level, dynamic range, T-NRT and power consumption) and intracochlear position of the active electrode were analyzed with Nucleus Custom Sound 4.4 software.


Eligibility Criteria:
Inclusion Criteria:

* successful cochlear implantation with CI532 or CI512 or CI522
* gave informed consent

Exclusion Criteria:

* unsuccessful cochlear implantation
Effectiveness of Reduced GCSF Dosing in Patients With a Low to Moderate Risk of Febrile Neutropenia

The study aims to confirm that a reduced dosage of GCSF is effective in preventing febrile neutropenia among patients with breast cancer, treated with chemotherapy and presenting with a low to moderate risk of developing febrile neutropenia.


Eligibility Criteria:
Inclusion Criteria:

Breast cancer Chemotherapy administration (new line) Chemotherapy type : FEC, EC, AC, docetaxel containing regimen Chemotherapy setting : adjuvant or neoadjuvant

Exclusion Criteria:

Eligibility to receive reimbursed GCSF
Improvement of Range of Motion in Frozen Shoulder in Breast Cancer Survivors

The prevalence of shoulder joint disease is high in breast cancer patients. The cause of adhesive capsulitis is not clearly identified. However, the following are known as relevant factors that are the restriction of the use of the arm after surgery, inflammation due to autoimmune action, radiation therapy, and adhesion of the surgical site. The purpose of this study is to compare and analyze the effect of intrathecal steroid injection in breast cancer survivors with adhesive capsulitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent breast cancer surgery within 6 months.
* Patients with shoulder pain and limited range of motion

Exclusion Criteria:

* Patients with infection
* Bilateral shoulder pain patient
* Patients with uncontrolled diabetes
Sirolimus vs Mycophenolate With Tacrolimus in Simultaneous Pancreas and Kidney Transplantation

This is prospective randomized open single center clinical study to compare effect of sirolimus vs mycophenolate tacrolimus based protocol on pancreas and kidney graft survival in simultaneous pancreas and kidney recipients.

MTOR (mammalian target of rapamycin) inhibitors represent group of immunosuppressive drugs with mechanism of T-cell blockade complementary to calcineurin inhibitors. The investigators presume that combination of sirolimus with tacrolimus will result in better survival of pancreatic and kidney grafts in simultaneous pancreas and kidney transplantations.

The study is proposed as a single-center extension of EUROSPK 002 trial originally started in 2004 by the EUROSPK Study Group. Recruitment of recipients started in 2004 with approval of EUROSPK 002. The patient recruitment has continued in a single center (Institute for Clinical and Experimental Medicine in Prague, Czech Republic) using the same inclusion and exclusion criteria. The recipients of primary kidney and pancreas transplantation have been randomized into 2 arms.

* In the intervention arm sirolimus is added to protocol at a dose of 5 mg immediately before transplantation, the dose is adjusted to maintained trough sirolimus trough levels between 5-10ng/ml.
* In the control arm mycophenolate mofetil was added to tacrolimus. Starting with 1g before transplantation, the dose has been increased to 1g bid afterwards.

Induction protocol at day 0. consists of ATG (antithymocyte globulin)induction 8mg/kg , Tacrolimus 0.05mg/kg, Methylprednisolone 125mg. Dosing of tacrolimus has been adjusted to maintain trough levels between 5-10ng/ml. ATG was administered at 3mg/kg on days 1.-3. Steroids have been gradually tapered from a dose of 20 mg prednison orally and withdrawn by 6w after transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus
* End stage kidney failure
* Negative CDC crossmatch
* Female patients of childbearing age must have a negative pregnancy test
* Patient must have signed the Patient Informed Consent Form.
* Patient must receive a primary simultaneous pancreas/kidney (SPK) cadaver transplant,

Exclusion Criteria:

* Patient is pregnant or breastfeeding.
* Patient is allergic or intolerant to Mycophenolate Mofetil, Sirolimus, ATG, Tacrolimus
* Patient has malignancy or history of malignancy, with the exception of adequately treated localized squamous cell or basal cell carcinoma, without recurrence.
* Patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior to randomization.
* Patient has any form of substance abuse or psychiatric disorder or condition, which invalidate communication.
* Severe cardiac failure or severe liver failure diagnosed at the time of transplantation
N-Acetyl-Cysteine (NAC) in Early Phase Schizophrenia Spectrum Psychosis

The investigators seek to examine the effect of add-on N-Acetyl-Cysteine (NAC) in the early phase of schizophrenia spectrum illness in collaboration with researchers Kim Do, PhD, and Philippe Conus, MD in Switzerland. Modifications of brain structure are thought to occur during the pre-illness phase and around the transition to psychosis. Therefore, studying new treatments that could target changes occurring during this period is of critical importance.

Aims:

Does add-on NAC treatment in early psychosis influence:

* positive and negative symptoms
* extrapyramidal side-effects of other medication
* plasma concentration of glutathione
* Mismatch Negativity, a physiological marker

The study proposes that a glutathione deficit leading to an abnormal response to oxidative stress is a vulnerability factor, combined with other brain specific factors, in brain functioning of some individuals with schizophrenia (Do et al., 2010). N-acetyl-cysteine is hypothesized to cross the blood-brain barrier and increase glutathione in the brain.

Eligibility Criteria:
Inclusion Criteria:

* Capacity to provide informed consent
* DSM IV TR diagnosis of schizophrenia, schizophreniform, schizoaffective
* Psychiatric and medical stability
* Prescribing clinician's premission to participate, assurance of medical stability
* Having met threshold criteria for psychosis on CAARMS (Comprehensive Assessment of at Risk Mental States Scale) Psychosis subscale
* Up to 12 months of antipsychotic treatment

Exclusion Criteria:

* Severe medical comorbidities
* Previous cerebral trauma
* Substance induced psychosis or organic psychosis
* Mental retardation
* NAC allergy
* Pregnancy, females and males planning pregnancy
* Treatment with antioxidants
* Insufficient command of English
Carboplatin and Temozolomide (Temodar) for Recurrent and Symptomatic Residual Brain Metastases

Purpose: The primary objective of this study is to determine if chemotherapy with carboplatin and temozolomide significantly affects the response rates, or size of disease, in patients with brain metastases, originating from cancer in other parts of the body, compared to patients who have already been treated with radiation. Survival, causes of death, recurrence of disease in the central nervous system, toxicity, and quality of life will all be measured as secondary objective in this study.

Rationale: Surgery and radiation are often used as treatments for brain metastases, or tumors in the brain that originate from other parts of the body. It is currently unknown whether patient survival or time to progression would experience additional benefits through the addition of chemotherapy. Previous research does appear to suggest that a chemotherapy regimen may improve outcomes of patients with brain metastases previously treated with radiation. The current study further evaluates this research question by providing patients with recurrent or symptomatic residual brain metastases with carboplatin and temozolomide, two chemotherapy agents. Temozolomide has demonstrated clinical antitumor efficacy against malignant gliomas and has been tested with some efficacy against several other types of cancer. This drug appears to have less adverse effects compared to other commonly used cancer drugs. Recent research indicates that temozolomide also has some efficacy against brain metastases. In addition, previous research indicates carboplatin's lack of severe toxicity in patients with this disease.

Treatment: Study participants will be treated with carboplatin and temozolomide. Carboplatin will be administered through intravenous infusions. Temozolomide will be given through oral pills. Before these drugs are administered, study participants will undergo a pre-treatment evaluation with physical and neuropsychological examinations, neuro-imaging, laboratory tests, quality of life assessment, and other procedures. Carboplatin will be given for two consecutive days. Temozolomide will be taken by study participants daily for five consecutive days. Both of these treatment schedules will be repeated every 28 days. Several tests and exams will be given throughout the study to closely monitor patients. Study treatments will be discontinued due to disease growth or unacceptable adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed systemic cancer

Exclusion Criteria:

* Pregnant
* Known CNS meningeal involvement with cancer
An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADH

This is a retrospective chart review non-interventional study designed to collect real world data on the use and outcomes of tolvaptan for the treatment of patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone (SIADH) secretion.


Eligibility Criteria:
Inclusion Criteria:

* Provision of patient informed consent unless a) not required by local regulations, b) it would take a non reasonable effort or c) if the source patient is deceased or untraceable.
* Female and/or male patients aged 18 years and over.
* Patients who received at least 2 doses of tolvaptan, for the treatment of one occurrence of hyponatraemia secondary to SIADH.

Exclusion Criteria:

* A patient cannot take part in this study if participating in any other clinical study in which the medicinal product aims to treat the causes or symptoms of hyponatraemia at the time of the hyponatraemia episode being documented in the current study.
Health Condition of Cannabis Consumers in the Canadian Population

This study evaluates the health condition and its evolution with time of Cannabis consumers in the Canadian population.

In Canada, legalization of recreational use is likely to have decreased the perception of risks associated with Cannabis use, and means that the reported adverse effects of Cannabis are not so important, suggesting that Cannabis may be useful for their illness as an alternative or complementary therapeutic.

More Canadian physicians prescribed Cannabis for their patients. Both Recreational and medical use of Cannabis increase and will continue to grow up in the next coming years. Regardless, the typology of Cannabis use, more information on the health condition of Cannabis consumers may be helpful for the medical prescription of Cannabis, in particular in older adults who are more at risk of side effects.

Eligibility Criteria:
Inclusion Criteria:

* Living in Canada the last 20 years
* Being 60 years and over
* Being consumer of cannabis

Exclusion Criteria:

* Living outside Canada the last 20 years
* Have never consumed cannabis
An Evaluation of a Dynamic Web-Based Visualization of Community Immunity

This study is a PhD project conducted by Ms. Hina Hakim, supervised by Dr. Holly O. Witteman, PhD, and co-supervised Dr. Daniel Reinharz, professors and researchers at the Faculty of Medicine at Laval University. The purpose of this study is to evaluate the effects of visualization conveying the concept of community immunity or herd immunity on risk perception (towards individual, family, community and vulnerable people in communities) (primary outcome) and on emotions, attitudes, knowledge, and behavioural intentions (secondary outcomes).

Visualization is a powerful communication mechanism that uses pre-attentive processing to communicate large amounts of information rapidly in understandable and compelling ways (Healey and Enns 2012). A systematic review demonstrates that there are some interventions available for conveying the concept of community immunity, and very few evaluate interventions for their effects on vaccine intentions and uptake as well as their precursors, such as knowledge, attitudes, knowledge and none on emotions (Hakim et al. 2018).

The purpose of this study is to evaluate the effects of visualization conveying the concept of community immunity on risk perception (to individual, family, community and vulnerable people in communities) (primary outcome) and on emotions, attitudes, knowledge, and behavioural intentions (secondary outcomes).

Eligibility Criteria:
Inclusion Criteria:

* Members of the general population in Canada
* At least 18 years old
* Able to provide free and informed consent
* Able to read and understand French or English
* Able to use a computer

Exclusion Criteria:

- No internet access
Clinical Study to Prove Safety in Use (Irritability and Sensitization in Genital Mucosa) of an Intimate Lubricating Gel

The purpose of this study is to check the safety under normal conditions of use through the emergence of signs of irritability and sensitization of the genital mucosa.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age between 25 to 55 years old
* Regular Menstrual Cycle
* Intact skin in product analysis área
* No prior reactions to topical products
* Being a user of products from the same category
* Reading, understanding, agreement and signature of the informed consent form

Exclusion Criteria:

* Pregnancy or risk of pregnancy
* Lactation
* Use of anti-inflammatory and immunosuppressive from 30 days up to three months prior to selection;
* Diseases that cause imune suppression;
* Endocrine disorders such as thyroid, ovarian or adrenal gland disorders;
* Any infection in the region where the product will be analyzed diagnosed at enrollment;
* Other conditions considered by the investigator physician as reasonable for the disqualification of the individual's participation in the study.