cyrilzakka/clinical-trials huggingface dataset:
Combined, Intensified and Modulated Adjuvant Therapy in Prostate Carcinoma

Patients with high risk prostate cancer may benefit from radiotherapy after radical prostatectomy. The investigators postulated that adjuvant androgen deprivation therapy (ADT), radiation dose escalation, and selective pelvic irradiation may improve outcome. A phase II trial was designed to prove that combined-intensified-modulated-adjuvant (CIMA) treatment may improve 5-year biochemical relapse free survival (bRFS) from 75% to 90% in high risk patients. The delivered dose to tumor bed and pelvic nodes was 64.8-70.2 Gy and 45 Gy (57% of patients), respectively, and 69% received ADT.

Prostate cancer patients at high risk of loco-regional recurrences may benefit from postoperative radiotherapy (RT) following radical prostatectomy (EORTC trial 22911). However, despite an improvement in biochemical relapse-free survival (bRFS), the risk of recurrences remained high for those patients. The investigators postulated that adjuvant androgen deprivation therapy (ADT), radiation dose escalation, and selective pelvic irradiation for patients at risk for regional failures may improve the outcome. The combined-intensified-modulated-adjuvant (CIMA) as described may improve survival through a reduction of loco-regional and systemic failures.

A phase II trial was designed to test the hypothesis that CIMA treatment may improve 5-year bRFS by 15%. Patients less than 80 years old, with a histological diagnosis of prostate adenocarcinoma without distant metastases, stage pT2-4 N0-1, no previous treatments and an ECOG performance status of 0-2 were selected. All patients had at least one of these pathologic features: extracapsular extension, positive surgical margins, or seminal vesicle invasion. Radiation dose to the tumor bed ranged from 64.8 to 70.2 Gy. Pelvic lymph nodes were treated to 45 Gy in selected patients at risk of regional failures (57%). Selected patients at risk for distant metastases (69.1%) received hormonal therapy.

Eligibility Criteria:
Inclusion Criteria:

* \< 80 years old
* histological diagnosis of prostate adenocarcinoma
* no distant metastases
* stage pT2-4
* N0-1
* ECOG performance status of 0-2
* One of these pathologic features: extracapsular extension, positive surgical margins, or seminal vesicle invasion. extracapsular extension, positive surgical margins or seminal vesicle invasion, or positive lymph-nodes
* No surgical complications such as pelvic infections or lymphocele, intraoperative rectal injury or severe urinary incontinence
* Preoperative and postoperative PSA test, bone scan and CT-scan or MRI of abdomen and pelvis prior to enrolment
* Normal bone marrow function

Exclusion Criteria:

* Previously treated with Radiotherapy
* Previously treated with androgen deprivation therapy
* Previously treated with chemotherapy for prostate cancer. They also had to be free
Physiological Responses in Robotic Neurorehabilitation

Robotic rehabilitation is very useful for improving functional recovery in neurological patients, there is not much evidence on its role in improving physiological responses (i.e. intestinal motility, orthostatic pressure), which are often abnormal in these patients.

To this end, we designed a randomized controlled experimental study on neurological patients, with the aim of evaluating the effects of robotic neurorehabilitation using Lokomat on physiological responses, compared to traditional therapy.


Eligibility Criteria:
Inclusion criteria: diagnosis of neurological disease; age between 18 and 75; and Caucasian ethnicity; a FIM motor score equal to or greater than 30.

Exclusion criteria: patients with a history of concomitant brain surgery; severe cognitive or language impairment; systemic, bone or joint disorders; presence of disabling sensory alterations; concomitant medical and psychiatric illness that could interfere with VR training.
Intervention Program With Perpetrators of Intimate Partner Violence

The current project aims to develop, implement and assess the effectiveness of an intervention program for perpetrators of intimate partner violence (both volunteers and court-mandated) that incorporates Motivational Interviewing techniques (MIT) as well as cognitive-behavioral and psychoeducational strategies implemented in a community setting. The intervention focuses on ending violence against the intimate partner and promoting the batterer's personal and social skills. The study uses pre- and post-treatment measures, with an experimental group (intervention) and two control groups (a group without intervention and a group without MIT). Data were collected at pre-test, post-test, and follow-up.


Eligibility Criteria:
Inclusion Criteria:

* being an adult male;
* having perpetrated physical, psychological, and/or sexual violence against a female intimate partner or ex-partner;
* be able to read and write.

Exclusion Criteria:

* psychotic disorders;
* cognitive impairment;
* psychological and/or personality disorders;
* substance abuse.
Prevalence, Strain Circulation and Disease Burden Study of Seasonal Influenza A and B in Panama, Selected Countries of Central America and the Caribbean From the Year 2010 to 2015

The purpose of this study is to assess the prevalence, strain circulation and disease burden of seasonal Influenza A and B in Panama, selected countries of Central America and the Caribbean from the Year 2010 to 2015.

The Gorgas Memorial Institute for Health Studies (ICGES) is a public health institution established in Panama dedicated to health research and disease prevention. It has been performing virological isolations of influenza and is a part of the World Health Organisation (WHO) Global Influenza Surveillance and Response System (GISRS) and a direct collaborator of the Centre for Disease Control and Prevention (CDC).

From 2010 a sentinel surveillance program is being conducted in Panama within the ICGES to collect data on influenza and other respiratory viruses using CDC guidance for Respiratory Disease Surveillance. This study aims to utilize this data source for analyzing the burden of influenza within the region.

Eligibility Criteria:
Inclusion Criteria:

* All subjects diagnosed with seasonal influenza A and/or B, reported in the ICGES database of Panama, from January 2010 to December 2015.

Exclusion Criteria:

* N/A.
"Iron Overload and Endocrinological Diseases"

Patients with hemochromatosis or Thalassemia develop progressive tissue and organs damages secondary to iron overload. Iron overload can result both from transfusional hemosiderosis and excess gastrointestinal iron absorption. Iron deposition in the heart, liver, and multiple endocrine glands results in severe damage to these organs, with variable degrees of endocrine and organ failure.

Although patients with iron overload often present endocrine disorders, the pathogenetic mechanisms underlying endocrinopathies are not completely clear. In particular it is not elucidated if the spectrum of endocrinopathies could change with advancing age. All endocrinological comorbidities can develop from a primary damage of the target gland, from pituitary secondary failure or from both.

The aim of this study is to investigate the prevalence of endocrinological diseases in adult patients with iron overload due to β-thalassemia or hemochromatosis and their impact on well-being and quality of life.

The study design is a prospective cross-sectional clinical study. All subjects enrolled will be evaluated for the endocrine diseases. The study protocol will include data collection from family and patients' history of diseases, physical examination, hormonal assessment for all endocrine axes and instrumental examinations.

The results will provide evidence on the prevalence of endocrine diseases in patients with iron overload and will add information to characterize the type and the degree of endocrine deficiencies, and on the pathogenic mechanisms involved, in order to individualize diagnostic and therapeutic approaches.


Eligibility Criteria:
Inclusion Criteria:

* Certain diagnosis of β-thalassemia major or intermedia
* Certain diagnosis of Hereditary Hemochromatosis
* Adult patients with an age between 18 and 65 years

Exclusion Criteria:

* Subjects with an age \< 18 and \> 65 years
the Effect of Music on Pain and Women Satisfaction During Diagnostic Outpatient Hysteroscopy in Postmenopausal Women

The aim of this study is to demonstrate the value of music in diagnostic outpatient hysteroscopy on patients' level of pain and satisfaction in postmenopausal women


Eligibility Criteria:
Inclusion Criteria:

* Menopausal patients with an indication for ofﬁce hysteroscopy (postmenopausal bleeding or abnormal ultrasound ﬁndings)

Exclusion Criteria:

* patients with cervical pathology retroverted uterus (detected by transvaginal ultrasound) previous cervical surgery patients with severe vaginal bleeding
Safety Study of Multipotent Progenitor Cells for Immunomodulation Therapy After Liver Transplantation

MultiStem ® is a new biological product, manufactured from human stem cells obtained from adult bone marrow. Factors expressed by MultiStem cells are believed to regulate immune system function and augment tissue repair.

Standard of care pharmacological immunosuppression after liver transplantation can achieve reasonable survival of liver grafts and patients. The side effects of this treatment, however, are clinically significant and diminish the overall success of organ transplantation as a curative therapy. It is therefore the objective of this study to implement cellular immunomodulation therapy with MultiStem as an adjunct to standard pharmacological immunosuppression with the ultimate goal of significantly reducing drug-based immunosuppression.

As this is the first study with MultiStem in this subject population it has been designed as a safety and feasibility trial. However, first evidence of a potential benefit for this patient population will be explored cautiously.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years of age undergoing allogeneic liver transplantation
* Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Written informed consent prior to any study procedures

Exclusion Criteria:

* Known allergies to bovine or porcine products or any other ingredients of the product
* Patients older than 65 years of age
* Patients listed in a high-urgency status that would not allow proper preparation of the study interventions
* Patients receiving a secondary liver graft (Re-Transplantation)
* Double organ transplant recipients
* Pre-existing renal failure that requires or has required hemodialysis within the last year
* Pulmonary function: FEV1, FVC, DLCO ≤50% predicted
* Cardiac function: left ventricular ejection fraction ≤50%
* HIV seropositive, varicella virus active infection or any other clinically relevant infection
* History of any malignancy (including lymphoproliferative disease and hepatocellular carcinoma) except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence
* Unstable myocardium (evolving myocardial infarction), cardiogenic shock
* Females of childbearing potential (hormonal status and gynecological consultation required)
* Patients with portal vein thrombosis
* Patients with a history of pulmonary embolism
Aggressive Cholesterol Therapy to Inhibit Vein Graft Events After CABG (ACTIVE Trial)

During coronary artery bypass graft surgery (CABG), saphenous vein from the leg is used to bypass the atherosclerotic blockages in the arteries of the heart. Unfortunately, vein bypasses themselves develop blockages over time, a process termed saphenous vein graft disease. By lowering cholesterol levels in the blood, statin medications are used after surgery to prevent the development of atherosclerotic blockages in the vein bypasses. Recently, higher doses of statin medications have been introduced, with some studies showing that they are more effective than traditional doses when used in heart attack patients. Furthermore, laboratory tests have shown that higher doses of statin medications can slow the development of atherosclerosis. Despite these benefits, very little is known regarding the use of high-dose statin therapy after bypass surgery in humans.

The goal of this study will be to see if high-dose statin therapy will prevent the development of vein graft occlusion during the first year after bypass surgery. Patients will be randomized to receive either high-dose statin therapy or conventional moderate-dose statin therapy starting within 4 days of surgery and continuing for the duration of one year after the operation. The statin medication will be given in capsule form. During the course of this study, neither the patient nor the health care team will know which treatment each patient is receiving. One year after bypass surgery, a computed tomography (CT) coronary angiogram will be performed to evaluate the patency of the vein bypasses.

The current clinical guidelines recommend treatment to achieve LDL levels \<100 mg/dL after surgical coronary revascularization. However, recent studies have illustrated that even more intensive lipid reduction with high-dose statins can further improve cardiovascular outcomes. Targeting LDL levels to 70 mg/dL after CABG with intensive statin therapy may prevent the process of postoperative saphenous vein graft disease and lead to improved graft patency. Therefore, in the ACTIVE Trial, we will conduct a randomized controlled trial comparing high-dose (80 mg atorvastatin) to moderate-dose (10 mg atorvastatin)statin therapy in patients undergoing CABG with saphenous vein grafts. The effect of aggressive cholesterol therapy on the process of vein graft disease will be examined with computed tomography (CT) coronary angiography one year after CABG. This study will address the subject of postoperative high-dose statin therapy and help determine the optimal lipid-lowering strategy following CABG.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing first-time CABG with at least 1 saphenous vein graft

Exclusion Criteria:

* Redo-CABG
* Statin allergy
* Severe renal dysfunction
* Severe liver disease
A Single Dose Of GSK189075 Taken By Mouth Containing Small Amounts Of Radioactivity Studied In Healthy Male Volunteers

This study will look at the relative amounts of GSK189075 that are found in samples of blood, urine, and feces of healthy male volunteers. Results of the study will be used to understand how the drug is converted in the body and how it is eliminated.


Eligibility Criteria:
Inclusion Criteria:

* Are a healthy, non-smoking male.
* Are 30 to 55 years old, inclusive.
* Have a Body Mass Index (BMI) between 19-30 kg/m2, inclusive; and a body weight \>110 lbs.
* Have a history of regular bowel movements (at least 4 times per week).
* Are willing and able to provide written informed consent before the start of any study-related procedures.

Exclusion Criteria:

* Have any significant laboratory abnormality or history of liver or kidney disease.
* Have any significant abnormality in your electrocardiograms (ECG) which are recordings of your heart rhythm.
* Have a current condition(s) that alters normal gastrointestinal (GI) function (such as constipation or removal of your gallbladder).
* Have an illness that requires treatment by a physician in the 30 days before screening or a fever and illness in the 5 days before dosing.
* Have blood pressure that is outside the normal range.
* Have a resting pulse rate that is outside the normal range.
* Have had surgery within 3 months before screening, unless approved by the GSK medical monitor.
* Have a drug allergy which the investigator feels would make it unsafe for you to participate in the study.
* Have a history of or current abuse of alcohol.
* Have a history of or current use of illicit drugs, or a positive drug screen.
* Have used tobacco products within 3 months prior to screening or have a positive cotinine test result.
* Are unable to refrain from foods or beverages containing coffee, tea, or chocolate for 72 hours before dosing with study drug and until 24 hours after dose.
* Have a positive test for human immunodeficiency virus (HIV) antibody or hepatitis B surface antigen or hepatitis C antibody.
* Have taken prescription or non-prescription drugs, including vitamins, herbal products, or plant-derived supplements (including St John's Wort) within 14 days (or less than 5 half-lives) before the first dose of study medication, unless approved by the GSK medical monitor
* Have participated in an investigational drug study within the 30 days before screening, or participated within the last 12 months in a study with another radio labeled drug product.
* Have a total radiation exposure from the previous 3-year period that is over 10 mSv (either from your work or through participation in other research studies). Clinical (therapeutic or diagnostic) exposure will not be included.
* Have donated blood (450 mL or more) within the previous 12 weeks.
* Are in an occupation which requires monitoring for radiation exposure, nuclear medicine procedures or have had excessive x-rays within the past 12 months.
* Are not able to follow the study directions.
Ussing Experiments to Evaluate the Role of Medication-induced Microscopic Colitis

Medication use, especially NSAIDs and PPIs, prior to diagnosis is considered a risk factor for MC development. However, the exact pathophysiological mechanism is unclear. It is hypothesized that NSAIDs, PPIs, and SSRIs may have an effect on the colon permeability, due to an idiosyncratic reaction which results in a local immune response. MC patients are considered to be susceptible hosts, prone to react on administration of abovementioned drugs. In order to test this hypothesis and to generate new insights in the pathophysiology of MC, we want to perform an Ussing chamber experiment using fresh colon tissue samples. The primary objective is to assess ex vivo the effect of NSAIDs and PPIs on epithelial permeability of colon biopsy specimens of MC and non-MC patients, using the Ussing chamber system


Eligibility Criteria:
Inclusion Criteria:

* The indication for colonoscopy is a relapse of MC (active) / MC in remission (remission) / no MC (control)
* Patient is not treated with NSAIDs / PPI / SSRI in week before inclusion

Exclusion Criteria:

* Age below 18 years at the time of diagnosis
* Use of anticoagulants or immunosuppressive drugs
* Severe co-morbidities hindering an endoscopic procedure
* A previous history of any type of chronic colitis, IBS, IBD, colon carcinoma or (partial) colectomy
* A recent (last year) diagnosis of infectious diarrhea or radiation proctitis.
* Use of medication known to influence intestinal permeability
* Excessive alcohol usage (\>20 standard units per week)
* Not capable of signing an informed consent
New Triple Hop Test Quality Assessment Tool

This study will develop a new jump assessment tool for the Triple Hop Test, and will test its reliability on adolescent and adult, healthy and post- anterior cruciate ligament (ACL) population.

Creating a new assessment test for a jump test that incorporates the known movement components that are important after an ACL injury can improve patient evaluation, decision for return to sport activity and injury prevention.

Study population- Adults, women and men aged 20-45, boys and girls aged 12-15. uninjured population: non symptomatic subjects, without major injury in their history. Injured population: ACL injured subjects, 9-12 month after beginning of treatment/surgery.

Stages of study:

stage 1- The investigators will create a new high-quality literature-based assessment test for the triple hop test (NTHT). The test will have 10 sections, its score ranges from 0 to 14 points and a high score means poor performance.

Stage 2- Performing reliability tests between and within the testers for NTHT. The tests will be done with the help of video photography of NTHT.

Stage 3- Performing NTHT and THT tests on healthy adult and adolescent subjects and on ACL adult and adolescent subjects, assessing the NTHT by watching video performance.

Eligibility Criteria:
Inclusion Criteria uninjured population:

* non symptomatic subjects
* without major injury in their history.

Inclusion Criteria injured population:

* ACL injured subjects
* 9-12 month after beginning of treatment/surgery.

Exclusion Criteria uninjured population:

* acute pain
* knee instability symptoms
* history of lower leg injury
* unable to jump on one leg
* knee ligament injury.

Exclusion Criteria Injured population:

* late in rehabilitation program
* unable to jump or run
* instability symptoms.
Multicenter CTS Pre-and Post-Transplantation Covid-19 Serum Studies

The Covid-19 Serum Study is a prospective case-control study in

1. kidney or liver transplanted patients being hospitalized due to an infection with Severe Acute Respiratory Syndrome Coronavirus Type 2 (SARS-CoV-2) after transplantation (TX) (POST-TX Covid-19 Serum Study)

   or
2. patients receiving kidney or liver transplantation after having had a SARS-CoV-2 infection (PRE-TX Covid-19 Serum Study)

The aim of this study is to evaluate the development of de novo donor specific antibodies (dnDSA) in transplanted patients being hospitalized due to an infection with SARS-CoV-2 (POST-TX Covid-19 Serum Study) as well as in patients receiving kidney or liver transplantation after having had an infection with SARS-CoV-2 prior to transplantation (PRE-TX Covid-19 Serum Study).

Further, the investigators will evaluate possible consequences of having had a SARS-CoV-2 infection prior or after liver or kidney transplantation with regard to graft survival and incidence of graft rejection episodes as well as SARS-CoV-2 specific antibody development after SARS-CoV-2 infection.


Eligibility Criteria:
Inclusion Criteria:

* Kidney-transplant recipients and full-size liver-recipients (de-novo or re-transplanted)
* Participant or legal guardian is willing and able to give informed consent for participation in the trial
* SARS-CoV-2 infection before transplantation (PRE-TX Covid-19 Serum Study) or after transplantation (POST-TX Covid-19 Serum Study)

Specific Inclusion Criteria for PRE-TX Covid-19 Serum Study:

* Kidney or liver transplantation between Dec 17,2020 - Dec 17, 2021

Specific Inclusion Criteria for POST-TX Covid-19 Serum Study:

* Hospitalization due to SARS-CoV-2 infection in between Dec 17,2020 - Dec 17, 2021

Exclusion Criteria:

* Participants not meeting the inclusion criteria
* multi-organ transplant recipients
Validity of a Supersimplified Device for Diagnosis of Patients With Suspected Obstructive Sleep Apnoea-hypopnoea (OSAH)

The diagnosis of OSASH requires expensive sleep tests that generate long waiting lists, so we need simplified and rapid diagnostic tools. The ApneaLinkTM, is a device that allows the assessment of respiratory events by measuring the flow ventilation with a nasal cannula connected to a pressure transducer.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 to 75 years of both sexes.
2. clinical suspicion of OSAH defined as subjects with breathing pauses during sleep and / or asphyxiated sounds, with or without excessive daytime sleepiness as measured by the Epworth scale and who have asked for a sleep test to rule out OSAH.
3. Informed consent signed by the patient.

Exclusion Criteria:

1. Place of residence more than 100 km from the hospital.
2. inability to perform psychophysical study at home.
3. cardio-vascular disease, cerebro-vascular or respiratory or acute severe unstable as to preclude the proper conduct of studies at home and / or PSG in the laboratory.
4. Patients with chronic insomnia or recognize sleep less than six hours.
5. Patients with depression (both point 4 and 5 are the potential causes of false negatives in a PR for lack of sufficient sleep time).
6. nasal obstruction complete or nearly complete, which prevents obtaining a quality signal with MicroMESAM