cyrilzakka/clinical-trials huggingface dataset:
Study To Assess the Pharmacokinetics of AZD1656 During Coadministration With Simvastatin

To assess the pharmacokinetics of AZD1656 during coadministration with Simvastatin.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of T2DM for at least 1 year, treated with any metformin or metformin with one other oral anti-diabetic drug (OAD)
* Body mass index between greater than or equal to 19 and less than or equal to 42 kg/m2
* HbA1c greater than 6.5% at enrollment

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma, as judged by the Investigator, within 2 weeks before the first administration of the IP
* Significant cardiovascular event within the last 6 months prior to enrollment (eg, myocardial infarction/acute coronary syndrome, revascularisation procedure, stroke or transient ischaemic attack) or heart failure New York Heart Association (NYHA) class III-IV
A Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South Africa

The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK Biologicals' human rotavirus (HRV) vaccine given concomitantly with routine vaccines including OPV in HIV positive infants. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

HIV infected infants as determined prior to study entry (screening) and asymptomatic or mildly symptomatic (WHO stages I and II) of disease will be enrolled. The study will have two groups: Group HRV and Group Placebo. Three-dose immunisation will be administered at approximately 6, 10, and 14 weeks of age. Routine EPI (Expanded Program on Immunisation) vaccinations will be administered concomitantly with the study vaccines. At the time of first dose, subjects will be aged 6 to 10 weeks. This study will evaluate safety, reactogenicity and immunogenicity of the HRV vaccine relative to the placebo.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female between, and including 6 and 10 weeks of age at the time of the first vaccination.
* Written informed consent obtained from the parents or guardians of the subject
* Documented HIV status of the subject as confirmed by PCR.
* HIV asymptomatic and HIV mildly symptomatic; Stages I and II disease according to WHO's most recent classification for HIV stages in infants and children.
* Born after a gestation period of 36 to 42 weeks.

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Previous routine vaccination except OPV, BCG and HBV vaccination at birth
* Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
* History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
* Acute disease at time of enrolment.
* Gastroenteritis within 7 days preceding the study vaccine administration.
* Previous confirmed occurrence of RV gastroenteritis.
* Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
* HIV moderately and severely symptomatic: stages III and IV according to WHO's recent classification.
* Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
Good Intentions Study

The purpose of this study is to explore the effects of an intervention designed to help increase physical activity and decrease screen time.

The purpose of this study is to investigate attendance, exercise, and screen time habits in fitness center members. Because they are the population under investigation, recruitment will take place via the fitness center facilities. This population is under investigation because much of this population is sedentary and does not exercise at recommended levels, despite access to physical fitness facilities. This research will investigate methods to encourage physical activity in this population.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index from 18-45 kg/m2

Exclusion Criteria:

* have any medical conditions that prevent participant from safely taking part in physical activity
* currently a smoker
* are pregnant, breastfeeding, or plan to become pregnant
* have visited fitness centers more than eight times in the past two months
* exercise outside of fitness centers more than once a week for one hour at a time in the past month
* do not engage in more than 14 hours a week of screen-based activities
* do not have a primarily sedentary job
Pilot Study of the Feasibility of Multicenter NIRS Data Collection and Interventions for Desaturation in Cardiac Surgery

Using the 9 centers (Appendix B) involved with the planned multicenter NIRS comparative effectiveness trial the specific aims of this study are:

1. To demonstrate the feasibility of collecting rScO2 data from patients undergoing cardiac surgery in a multicenter study design.
2. To demonstrate the feasibility of using a standard algorithm for treating rScO2 desaturations during cardiac surgery in a multicenter study design.

Brain injury after cardiac surgery is a chief source of patient mortality and healthcare costs and can significantly impair quality of life. Reducing the burden of this complication has wide public health implications. The broad manifestations of perioperative brain injury include stroke, delirium, and cognitive decline.5 All forms of injury are believed to result primarily from cerebral embolism and/or reduced cerebral blood flow (CBF). The risk for cerebral hypoperfusion is likely the highest during cardiopulmonary bypass (CPB), when mean arterial pressure (MAP) is kept low (\~60 mmHg), particularly for patients who are aged and who have cerebral vascular disease. Near-infrared spectroscopy (NIRS) is used increasingly to monitor regional cerebral oxygen saturation (rScO2) in patients undergoing cardiac surgery, although limited data show that it improves patient outcomes. Regardless, clinical evidence supporting the efficacy of NIRS-based monitoring is needed urgently because the cost of NIRS sensors (\~$220/patient) could add $132 million annually to hospital costs for cardiac surgery. We must address this issue quickly because the rising prevalence of NIRS use and advocacy by experts and industry will likely soon result in NIRS becoming a standard of care. We are in the process of submitting a multicenter, prospectively randomized comparative effectiveness trial to assess the efficacy of NIRS monitoring in patients who are undergoing coronary artery bypass graft (CABG) surgery with CPB, and/or valve surgery, and who are at risk for brain injury. The goal of the planned proposal is to determine whether interventions to correct rScO2 desaturations (value \<50% or 20% reduction from room air baseline) reduce the frequency of neurologic and other complications compared with standard care (no clinical monitoring). In order to demonstrate feasibility of our proposal we need to demonstrate the ability of the team to collect rScO2 data from multiple centers and to show the ability of the team to properly follow an algorithm for treating rScO2 desaturations that occur during surgery. Thus, the aim of the current study is to collect preliminary data to support our larger comparative effectiveness trial.

Eligibility Criteria:
Inclusion Criteria: Patient inclusion criteria will be male or female patients \>50 years of age undergoing primary or re-operative CABG and/or cardiac valve surgery that requires CPB who will have NIRS monitoring for clinical indications.

-

Exclusion Criteria: Emergency surgery

-
The University of Freiburg Medical Center Extracorporeal Organ Support Device Registry

A prospective registry collecting pseudonymized clinical and treatment data from all patients treated with extracorporeal organ support (i.e., VV ECMO, VA ECMO, ECPR, Impella, IABP, and others) on the wards of the Department of Interdisciplinary Medical Intensive Care at the Freiburg University Medical Center.


Eligibility Criteria:
Inclusion Criteria:

* Treatment with any kind of extracorporeal organ support

Exclusion Criteria:

* none
Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Advanced Cancer Patients

The purpose of this study is to evaluate the use of olanzapine for the treatment of cancer patients with chronic nausea and/or vomiting unrelated to chemotherapy or radiation in a randomized placebo-controlled pilot trial.

Patients with advanced cancer experience a variety of physical and psychosocial symptoms that significantly affect the patients' quality of life. Chronic nausea is a particularly distressing symptom present in \>60% of patients with advanced cancer. A number of palliative care studies have evaluated treatments of nausea with limited success. Olanzapine with its unique formulation and decreased drug interactions compared to many other drugs appears to be a reasonable candidate for further evaluation. Olanzapine has significant potential for use in the prevention and treatment of nausea in a palliative care setting with a once-daily dosing.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age
* Have histologically or cytologically-confirmed malignant disease in an advanced incurable stage
* Have not received chemotherapy or radiation for \>14 days (advanced cancer patients receiving hormonal therapy or targeted therapy that does not come with a recommendation for prophylactic anti-emetic therapy are eligible)
* Have chronic nausea that has been present for at least one week (worst daily score \>3, 0-10 visual analogue scale) or vomiting at least five times over past one week
* Have serum creatinine \< 2.0 mg/dl and serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) \< 3 times upper limits of normal ≤120 days prior to registration
* Absolute neutrophil count (ANC) \>1500 mm3 \<120 days prior to registration
* Women of childbearing potential must consent to use adequate contraception throughout protocol therapy; females of childbearing potential must have a negative urine pregnancy test \<7 days prior to registration.

Exclusion Criteria:

* Not be receiving treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for less than or equal to 30 days prior to registration or planned during protocol therapy (patients may have received prochlorperazine and other phenothiazines as prior anti-emetic therapy)
* Not have concurrent use of ethyol
* Not have severe cognitive compromise
* History of central nervous system (CNS) disease (e.g. brain metastases, seizure disorder)
* Concurrent use of amifostine, concurrent abdominal radiotherapy; concurrent use of quinolone antibiotic therapy
* Chronic alcoholism (as determined by the investigator)
* Known hypersensitivity to olanzapine
* Known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the previous six months
* History of uncontrolled diabetes mellitus (stable insulin dose and/or stable oral hypoglycemic agent permitted)
* Planned chemotherapy or radiation during the 7 days following study initiation.
Clinical Trial to Evaluate Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19

This clinical trial is a randomized, blinded, two arms, placebo controlled, clinical trial to evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per hospital practice to prevent COVID 19 in subjects at risk of getting infected with COVID 19.

Approximately eligible 4000 subjects who are at risk of getting infected with COVID-19 (i.e. person living in same household as COVID-19 patients / healthcare workers providing direct care to COVID-19 patients) will be enrolled in to the study after due consent and based on the eligibility criteria.

Initially, 400 subjects at risk of getting infected with COVID-19 will be enrolled in the study and randomized in 1:1 ratio to receive either Mw (n=200) or placebo (n=200). After the interim analysis from the data of these 400 subjects for safety and efficacy and based on review and recommendations from DSMB / MC, modification in study design, objective or sample size will be considered.

Study duration for each subject will be of 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects of either gender, age ≥ 18 years, with recent history of close contact with COVID-19 patients.
* Subjects with SARS Cov 2 negative test (ICMR approved test kit) at screening visit.
* Female subject who are currently using reliable methods of contraception (barrier methods and intrauterine contraceptive device), with a negative urine pregnancy test during screening and agree to informed compliance of contraceptive method until at least months post-dosing.
* The subject must be able and willing to comply with the study protocol, available and willing to complete all the study assessments and must have signed an Informed Consent Form.

Exclusion Criteria:

* Any febrile illness with oral temperature \> 100°F within 3 days prior to randomization.
* Subject with past history of COVID-19 infection.
* Pregnant and / or lactating female subjects.
* Presence of any illness requiring hospital referral.
* Any confirmed or suspected immune-deficient condition based on medical history and physical examination and a family history of congenital or hereditary immunodeficiency or Individuals on immunosuppressant's as Azathioprine, Cyclosporine, Mycophenolate etc.
* History of allergic reactions or anaphylaxis to Mw or its component.
Comprehensive Surgical Coaching

Simulation in surgical skills training is widely accepted as a necessary step to improve surgical training outside the operating room. Simulation predominately focuses on teaching a specific task or procedure. Once this task is acquired ongoing optimization of technique is desirable. Commonly ongoing skills assessment occurs in the form of peer feedback throughout training rotations. This feedback is frequently subjective and of variable educational use. Identifying ongoing technical training needs and enabling personalized objective feedback represents an important training concept that has not yet been formally used in resident training.

The specific goal of this study is to prove the effect of a comprehensive surgical coaching (CSC) approach which combines concepts of behavior modeling training, task debriefing and error recognition to improve overall surgical technique without additional technical skills training.

Design The study design is a randomized, controlled trial involving evaluation of a study and a conventionally trained group at pretest and posttest.

Participants The study and control groups will consist of senior surgical residents (PGY 3-5) and surgical fellows involved in minimally invasive surgery (MIS).

Inclusion: Since concurrent operative training in the operating room (OR) in the technique of MIS is a prerequisite for this study, only residents and fellows on rotations with a practice focus on MIS during the time period of the study will be eligible for participation.

Exclusion: Individuals with severe illnesses precluding performance in the OR will not be included.

Outcome measures: Surgical performance will be assessed using a global rating scale as well as through tabulation of observed intraoperative technical errors. Primary outcome measure is surgical skill level before and after targeted training.

Eligibility Criteria:
Inclusion Criteria:

* surgical residents and fellows on rotations with a practice focus on minimally invasive surgery during the time period of the study

Exclusion Criteria:

* individuals with severe illnesses precluding performance in the OR
Evaluating a Fasting-mimicking Diet in Combination With Immunotherapy in Patients With Non-small Cell Lung Cancer

The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment.

Cancer cells use an increased supply of glucose to make energy and do not have protection against fasting that normal cells do. Because of this, researchers would like to study how fasting may help immunotherapy target cancer cells. Initial studies suggest that fasting may decrease the side effects of immunotherapy and increase the chances of your cancer responding to the immunotherapy. Patient populations will have non-small cell lung cancer in which pembrolizumab have been recommended to treat the cancer as part of standard care

Eligibility Criteria:
Inclusion Criteria:

* 18 years at the time of informed consent
* Ability to provide written informed consent and HIPAA authorization.
* Eastern cooperative group (ECOG) performance status of 0 to 2
* Newly diagnosed histologically or cytologically confirmed stage IV Non-Small Cell Lung Cancer (NSCLC). Patients with locally advanced NSCLC that are not candidates for definitive therapy but are candidates for trial are allowed per investigator discretion.
* BMI 19 kg/m2
* Patients should be enrolled prior to starting standard of care immunotherapy for the treatment of stage IV NSCLC. Patients should be on PD (L)1 inhibitor alone (i.e., with PD-L1 expression 50%) in the metastatic setting. The investigators will allow single agent pembrolizumab only as the checkpoint inhibitor.
* Patients requiring palliative radiation or definitive radiation to an oligometastatic disease prior to the initiation of single agent checkpoint inhibitors are allowed once radiation has been completed and patients have recovered from toxicities.

Exclusion Criteria:

* Self-reported weight loss of \> 10% in the 6 weeks prior to study entry
* History of symptomatic hypoglycemia or uncontrolled diabetes
* Prior therapies with inhibitors of insulin growth factor I(IGF-1) such as Linsitinib or Picropodophyllin
* Concurrent use of somatostatin
* Concurrent use of immunosuppressive medications including sirolimus, tacrolimus, mycophenolate mofetil, azathioprine, prednisone, dexamethasone, or cyclosporine
* Significant food allergies which would make the subject unable to consume the food provided.
* History or current evidence of any uncontrolled medical or psychiatric condition, therapy that may confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the participating subject as deemed by the treating investigator.
* Pregnant or lactating females are not eligible.
Two Approaches to Lower the Chances of Recurrence of Anal Fistula After Surgery

A total of 80 patients with complex fistula in ano of both genders were included. All patients in Group A underwent a loose seton technique. In group B, video-assisted fistula tract surgery (VAAFTS) was performed.Twice daily Sitz baths, analgesics, and stool bulking agents (bran) were used in follow-up care. Repeated examinations were carried out every four weeks and recurrence was noted at the end of three months

Patients were equally allocated into two groups i.e. Group A \& Group B by lottery method. In both groups, the lower bowel was emptied by an enema about an hour before the operation. All patients in Group A underwent the loose seton technique. The procedures were performed in the operating room with the patient in the lithotomy position. Probing of the fistula tract was done with a metallic malleable probe. The incision was given from the external opening of the fistula to the anal verge, involving the skin, subcutaneous tissue, superficial part of the external sphincter, and superficial part of the internal sphincter. After the insertion of loose Seton, a non-absorbable suture was left loosely and kept in situ for three months.

In group B, video-assisted fistula tract surgery (VAAFTS) was performed. The patients were positioned in the lithotomy position. The fistuloscope was then introduced into the external opening and the procedure was performed, except for the closure of the internal opening, which was performed with either a "figure of eight" suture or an advancement flap, rather than using a stapler. The tracts were destroyed using electrocautery, the necrotic tissues were removed, and the external openings were cored out and left open for drainage. The patients were discharged the day following the procedure. Twice daily Sitz baths, analgesics, and stool bulking agents (bran) were used in follow-up care. Repeated examinations were carried out every four weeks and recurrence was noted at the end of three months. The information (age, gender, duration of disease, BMI, diabetes mellitus, hypertension, place of living, and recurrence) was collected through pre-designed Performa (Annexure I).

Eligibility Criteria:
1. Inclusion Criteria:

   * complex fistula in ano (as per operational definition)
   * with a duration of disease \>1 month,
   * either gender
   * history of previous surgery for fistula in ano
2. Exclusion Criteria:

   * Pregnant females
   * bleeding disorder
   * history of pulmonary or systemic tuberculosis
Ischemic Preconditioning and Thiol-disulfide Balance

Various strategies have been proposed to prevent or mitigate the effects of ischemia-reperfusion injury following the use of tourniquets in orthopedic surgery cases. One of them is applying "remote ischemic preconditioning." This randomized controlled trial is planned to evaluate the effectiveness of remote ischemic preconditioning in preventing tourniquet-induced ischemia-reperfusion injury in total knee arthroscopy with dynamic thiol-disulfide homeostasis.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III patients who will undergo total knee arthroplasty surgery under elective conditions

Exclusion Criteria:

* emergency operation,
* Underlying neurological disorder,
* Underlying peripheral vascular disease,
* other types of concurrent surgery.
Detection of SARS-CoV-2 in Semen of COVID-19 Positive Males

The objectives of the study, are to describe detection of SARS-CoV-2 in the semen of COVID-19 positive patients, the duration of positive semen and to investigate the impact on semen quality, thereby providing insights into the early impact on male reproductive function.

SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), a novel coronavirus reported in late December 2019 in Wuhan, China, has spread world-wide with over 1,000,000 coronavirus disease 2019 (COVID-19) cases reported. New developments in molecular virology and immunobiology of SARS-CoV-2, improve our understanding about COVID-19 prevention, management, and possible long-term effects. Although viral transmission occurs predominantly through respiratory droplets, SARS-CoV-2 has been isolated in blood samples and feces from COVID-19 patients, raising questions about viral shedding in other bodily fluids, including semen, as well as alternative modes of transmission.

The objectives are to describe detection of SARS-CoV-2 in the semen of COVID-19 positive patients, the duration of positive semen and to investigate the impact on semen quality, thereby providing insights into the early impact on male reproductive function.

Eligibility Criteria:
Inclusion Criteria:

* Male
* PCR on nasopharyngeal swab positive for SARS-CoV-2
* Age: ≥ 18y - ≤ 50y
* Signed informed consent
* When undergoing ART treatment: ICSI treatment

Exclusion Criteria:

* Negative test of SARS-CoV-2 on nasopharyngeal swab sample
* History of immunosuppression
* Impossibility to deliver a semen sample at UZ Brussel on a weekly base
* When undergoing ART treatment: IVF treatment