cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate Long Term Immunogenicity up to 10 Years After the First Booster Immunization With Tick Borne Encephalitis Vaccine in Adults Who Received 1 of 3 Different Primary Vaccination Schedules

The aim of this study is to investigate the immunogenicity response in adults up to 10 years after one booster dose. Data collected from this study will allow for greater information to prescribers who administer TBE vaccine, so that they can appropriately time the administration of booster vaccinations to individuals who received different vaccination schedules and who live in tick borne encephalitis endemic regions.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed prior study - V48P7E1.

Exclusion Criteria:

* Subjects whose antibody responses to booster vaccine received in the parent study fell below protective levels, subjects who have been exposed to TBE or flavivirus vaccine, subjects with immunosuppression.
A Prospective Evaluation of Hemorrhoidal Surgery Outcome in Istanbul

This study aims to evaluate the effect of surgical treatments on the quality of life in hemorrhoidal disease. All available treatment methods will be included in this 1-year cohort which is going to collect data from a big metropol.


Eligibility Criteria:
Inclusion Criteria:

* Surgical interventions under local and/or general anesthesia
* Elective or emergency interventions (including thrombectomy)
* Surgical interventions in operation room or office
* Any kind of excision, sclerotherapy, ligation, suturation, ablation, mucopexy

Exclusion Criteria:

* Any accompanying perianal disease (anal fistula, anal fissure, perianal abscess, anal condyloma extending into the anal canal)
* Previous surgery for hemorrhoids (any intervention other than medical treatment)
* Previous perianal surgery (internal sphincterotomy, fistula surgery)
* Pelvic and/or perineal radiotherapy
* Previous obstetric or perianal injury and/or sphincter repair
* Previous rectal surgery (distal colectomy for benign or malignant etiology)
Gastric Motor Function Measurement in Dyspepsia and Normal Subjects

This study is being done to measure the functions of the stomach after eating a meal and to develop a new method that will simultaneously measure both gastric emptying and the relaxation of the stomach after a meal using nuclear medicine testing. This would make the testing more convenient for patients and will also offer better understanding of these two gastric functions.


Eligibility Criteria:
Inclusion criteria:

Dyspeptic Subjects:

* Recurrent episodes of upper abdominal pain or discomfort including early satiety, fullness, bloating, or nausea for at least 3 months in the prior year.
* A baseline impaired satiety test (maximum tolerated volume 25% of normal or 1000cc).
* No evidence on esophagogastroduodenoscopy of erosions, peptic ulcer, pyloric obstruction, esophagitis or malignancy in the prior 3 years.

All Subjects:

* No history suggestive of small bowel obstruction.

Exclusion criteria

* No structural or metabolic diseases/conditions that affect the gastrointestinal system.
* Unable to stop medications 48 hours prior to the study that:

  * Alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, SSRI and newer antidepressants.
  * Analgesic drugs including opiates, NSAID, COX 2 inhibitors
  * Systemic antifungal drugs
  * Carbamazepine, glucocorticoids, phenobarbital, phenytoin, rifampin, but also grapefruit juice.
  * Benzodiazepines NOTE: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection and birth control pills or depot injections are permissible.
* Female subjects who are pregnant or breast feeding.
* Significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study.
* Subjects who have participated in another clinical study within the past 30 days.
* Previous gastric or intestinal surgery (except appendectomy , cholecystectomy or hysterectomy).
Proton Radiation Therapy Registry

The Johns Hopkins Proton Therapy center is establishing a registry to capture the full 3D radiation dosimetry delivered to the patient, baseline clinical data, and disease, toxicity and quality of life outcomes. The goal is to have all patients treated at the proton center to be included in the registry to enable future comparisons of treatment outcomes to assist in understanding which patients can benefit from the use of protons.

Proton based radiation therapy has considerable dosimetric advantages over the standard photon based radiation therapy, with a significantly higher cost. The clinical advantages, however, may not be realized for all patient populations, even with the improved dose distributions. Establishing the clinical efficacy of proton therapy requires years of experience treating patients. The goal is to accelerate the knowledge gain through the use of the registry that allows for detailed information to be captured and is inclusive of every patient treated.

Eligibility Criteria:
Inclusion Criteria:

* All patients treated at the proton center.

Exclusion Criteria:

* Any other than what is supplied in the inclusion criteria
Study to Evaluate the Prospective Payment System

To describe trends in treatment patterns of Small Dialysis Organizations (SDOs) prior to and during the implementation of the Centers for Medicare and Medicaid Services' (CMS') policy \[End Stage Renal Disease (ESRD) Prospective Payment System (PPS)\] to bundle reimbursement for all dialysis services. Specifically, to describe CMS ESRD PPS quality performance measures for dialysis centers over time.


Eligibility Criteria:
Patient Inclusion Criteria:

* Adults ≥ 18 years of age who have given written informed consent
* Documented physician diagnosis of ESRD requiring dialysis and receiving care at a participating dialysis center
* Undergoing dialysis on the dialysis schedule assigned to the site

Patient Exclusion Criteria:

* Patients will be ineligible for the study if they do not consent to have their data collected for research purposes.
Functional Exercise for Sarcopenia

Sarcopenia is one of the major causes of functional decline and negative health outcomes among older adults. Prominent evidence suggests exercise interventions can reverse sarcopenia. However, past studies mainly focus on structured exercise programs, automatically excluding many older adults who are not motivated and lack the time/resources to conduct the structural exercise. Therefore, we propose to examine the effect of the Sarcopenia Translation functional Exercise Program (the STEP program) on community-dwelling older adults. The STEP is a functional exercise program designed to address low motivation and other time/resources barriers for rapid translation in community settings. The 12-week STEP program teaches older adults to apply functional exercise activities incorporating resistant training principles in their daily routines.

With a dual focus apriori in assessing clinical effectiveness and potential implementation strategies for future community implementations, we will conduct a single-blind randomized control trial among 60 community-dwelling older adults at risk or with sarcopenia. The study's purposes are threefold: (1) to assess the effect of the functional exercise intervention compared to usual care on primary outcomes of sarcopenia (muscle strength, muscle mass, and physical function); (2) to assess the long-term effects of the functional exercise intervention on primary outcomes of sarcopenia; (3) explore potential implementation strategies for rapid community implementation including development of a communityappropriate protocol for tracking long-term effects such as metabolomic biomarkers. This study aims to develop an effective functional exercise program as an alternative to structured exercise programs. Additionally, the goal is to accelerate the translation of the functional exercise program for older adults at risk or with sarcopenia in real-world settings.


Eligibility Criteria:
Inclusion Criteria:

1. age 65 or older
2. reside in northern Taiwan
3. at risk of /with sarcopenia determined by AWGS diagnostic guidelines

Exclusion Criteria:

1. meets physical activity guidelines for older adults: conduct at least 150 minutes of moderate-intensity activity or 75 minutes of vigorous-intensity activity weekly
2. needs 24-hour resistance for the activity of daily living activities
3. has severe knee or back pain
4. severely impaired mobility or wheelchair bounded (ruling out possible secondary sarcopenia patients)
5. unstable cardiac conditions such as ventricular dysrhythmias, pulmonary edema, or other musculoskeletal conditions
6. impaired cognition (Mini-Mental State Examination \[MMSE\] score \< 24, or \<17 for participants with lower education level)
7. has a metal clip, implant, or pacemaker
Study Comparing Lecozotan SR Two 5-mg Tablets Vs. Lecozotan SR One 10-mg Tablet in Healthy Subjects

To determine the bioequivalence between two 5-mg tablets of lecozotan and the new 10-mg tablet of lecozotan.


Eligibility Criteria:
Inclusion criteria:

* Generally healthy, man and women, aged 18 to 50 years.

Exclusion criteria:

* History or active presence of clinically important medical disease.
REMAP Trial for Optimizing Surgical Outcomes at UPMC

The purpose of this project is to determine the effect of various interventions to improve patient outcome as defined by hospital free days at day 90 for adult patients undergoing elective surgery. Within this project, multiple studies may be conducted.

The structure of this project permits:

* the testing of multiple treatments at the same time within the same patient
* the use of early study results to provide better treatment options to future patients
* the removal of treatments which are shown to be less effective than the other treatments
* the addition of new treatments

The first study to be conducted under this project (IRB STUDY19090186) is the Strategies to Promote ResiliencY (SPRY) clinical trial (IRB PRO18060038).

The SPRY clinical trial will determine the effectiveness of Metformin on improving surgical outcomes among nondiabetic older adults who are scheduled for elective surgery.


Eligibility Criteria:
UPMC REMAP

Inclusion Criteria:

* Adult patient evaluated pre-operatively for elective surgery at UPMC
* Minimum lead time before surgery to provide domain specific intervention (range 7-180 days pre-operatively)
* Age greater to or equal to 18 years of age

Exclusion Criteria:

* Death is deemed to be imminent or inevitable
* Emergency surgical procedure without suitable lead-in time
* Previous participation in this REMAP within the last 90 days, flagged by elective or emergency surgical encounter at UPMC in the past 90 days

SPRY Domain

Inclusion Criteria:

* Age \>= 60 years
* Age \< 60 but evidence of comorbidity risk as represented by a Charlson Comorbidity Index of \> 2 in 12 months prior to enrollment
* Able to take an oral medication in non-crushable pill form
* Women must be post-menopausal, which is defined as not having a menstrual period within the last 12 months

Exclusion Criteria:

* The treating clinician believes that participation in the domain would not be in the best interest of the patient
* Pre-existing diabetes type I or II
* Women of child-bearing potential
* Hospital stay \<24 hours
* Presently taking metformin or prior use in the past 6 months
* Evidence of an absolute or relative contraindication to Metformin therapy

  * Known allergy to metformin
  * Acute or chronic metabolic acidosis with or without coma
  * Hemodialysis, end-stage renal disease, or Glomerular Filtration Rate (GFR) \< 45 in the prior 30 days
  * Ongoing treatment with therapy known to have significant drug-drug interaction with metformin (carbonic anhydrase inhibitors, cimetidine, gliptins)
  * History of lactic acidosis
  * History of excessive alcohol intake
  * Severe hepatic dysfunction
Thumb Basal Joint (CMC I) Arthritis - Preoperative Anxiety/Depression, Outcome Instruments, Carpal Cinematics and Cost-utility

A project aiming to promote evidence based practice when treating thumb basal joint (CMC I) arthritis. We will aim to: 1) provide the minimal clinical difference of two general outcome instruments, 2) evaluate the association between pre-operative anxiety and/or depression and outcomes following trapeziectomy, 3) evaluate the effect of trapziectomy on carpal cinematics, 4) determine the cost-utility-ratio of trapeziectomy


Eligibility Criteria:
Inclusion Criteria:

* Eaton-Glickel \>2 arhritis
* Symptom duration \>3 months
* Pain VAS \>30mm
* No significant comorbidities, ASA I-II
* Fluent in Finnish language

Exclusion Criteria:

* Eaton-Glickel \<2
* Duration of symptoms \<3 months
* VAS \<30mm
* ASA \>II
* Inflammatory joint disease
* Systemic corticosteroid or immunomodulatory medication
* Upper limb symptoms not explained with CMC I artritis
* Heavy smoking (\> 20 cigarettes per day)
* Alcohol or drug abuse
* Neurological condition affecting upper limb function
* Other ipsilateral upper limb condition requiring surgery
The Effect of Sarpogrelate and High Dose Statin on the Reduction of Coronary Spasm

The aim of the study was to to evaluate the effect of sarpogrelate, a selective serotonin receptor antagonist, and high dose statin on the reduction of coronary spasm in the patients with variant angina.


Eligibility Criteria:
Inclusion Criteria:

* Clinical history of chest pain compatible with variant angina; morning chest pain aggravated by cold exposure.
* Angiographically proven coronary spasm; TIMI flow \< 3 by spontaneous coronary spasm or intracoronary ergonovine spasm provocation test.

Exclusion Criteria:

* Cardiac arrest by coronary spasm
* Left main coronary spasm
* Significant fixed coronary artery stenosis; Diameter stenosis \> 70% in the major epicardial artery by coronary angiography
* Left ventricular ejection fraction \< 30%
* Coagulation disorders or bleeding tendency (Platelet count \< 50k, PT INR \> 2.0)
* Significant liver disease (AST or ALT \> 100 U/ml)
* Renal failure (S-Cr \> 2.0 mg/dl)
* hypersensitivity for statin
* Pregnancy
High-Dose Vitamin D3 Supplementation in the Treatment of Human Immune Deficiency Virus Patients Trial

High-Dose Vitamin D3 in the Treatment of Human Immune Deficiency Virus Patients, A Double-Blind Randomized Control Trial Human immunodeficiency virus is a key challenge for global health. Vitamin D deficiency is common in people living with HIV infection. Antiretroviral therapy may create unique risk factors for vitamin D insufficiency, including alterations of vitamin D metabolism by ART.

The study is designed to evaluate the effect of high dose Vitamin-D supplementation in the treatment of HIV patients with Antiretroviral therapy.

Furthermore, in secondary outcomes study will evaluate the effects of high dose vitamin-D supplementation by Pre \& Post assessments of CD4 count and PCR count.

Secondary outcomes also includes the effects of high dose vitamin-D supplementation by Pre \& Post assessments of SGPT, SGOT, ALP and Bilirubin.

Tertiary outcomes includes the effects of high dose vitamin-D supplementation by Pre \& Post assessments of Hb, Lymphocytes, Monocytes, Eosinophil, Platelet count and Basophil count.

A sample size of 95 patients were recruited in Said Mitha Teaching Hospital Lahore.

Study is planned in two groups including 1) ARV + Vitamin-D3 2) ARV + Placebo. Methods/design: A randomized placebo controlled double-blind clinical trial of patients with age 19-50 years.

The primary outcome will be assessed by analyzing the difference change in the Vitamin-D Levels from Day 1 to Week 12. Secondary outcomes including viral load count, CD4 count, elevated levels of LFTs, will also be assessed by analyzing the mean difference in their values on week 12 after the supplementation of high dose Vitamin-D. Tertiary outcomes (Hematology) including Hb, HCT, TLC, Eosinophil's count, Neutrophils count, Monocytes and Platelets Data will be collected on a predefined Performa. All information will be entered in SPSS for the analysis.

Discussion: High dose Vitamin D supplementation in HIV-infected patients has not been previously investigated in Pakistan and it is unknown whether increasing levels is associated with improved clinical outcome or not. Therefore, it is significant to conduct a study to know the effect of vitamin D in the treatment of HIV patients with antiretroviral therapy.

Keywords: AIDS, HIV, anti-retroviral therapy, high dose 25-hydroxy Vitamin-D level, CD4 count, viral load.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 19 years and above
2. Vitamin-D levels less than 20ng/ml
3. Not taking any kind of Vitamin-D supplementation or Mega Doses for last six months
4. Written Informed Consent Form
5. PCR Positive Patients

Exclusion Criteria:

1. Pregnant and Lactating Women
2. Ability to take Study Medication Orally
Stereotactic Body Radiotherapy for Oligometastases From Colorectal Cancer

Single arms prospective phase II study of SBRT for oligometastatases from colorectal cancer

Single arms prospective phase II study of SBRT for oligometastatases from colorectal cancer, the primary concerns are treatment efficacy and toxicities.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years
* Eastern Cooperative Oncology Group (ECOG) performance score ≤ 1
* Diagnosis by pathological examination
* Primary lesion is under control by surgery
* Adequate blood counts:

  * White blood cell count ≥3.5 x 109/L
  * Haemoglobin levels ≥100g/L
  * Platelet count ≥100 x 109/L
  * Creatinine levels ≤1.0× upper normal limit (UNL)
  * Urea nitrogen levels ≤1.0× upper normal limit (UNL)
  * Alanine aminotransferase (ALT) ≤1.5× upper normal limit (UNL)
  * Aspartate aminotransferase (AST) ≤1.5× upper normal limit (UNL)
  * Alkaline phosphatase (ALP) ≤1.5× upper normal limit (UNL)
  * Total bilirubin (TBIL) ≤1.5× upper normal limit (UNL)

Exclusion Criteria:

* Primary lesion is not under control
* Pancreatic carcinoma
* Oligometastases could not be located
* Pregnancy or breast feeding
* Symptoms or history of peripheral neuropathy
Incidence of Incomplete Postoperative Neuromuscular Recovery From Anesthesia (P07535)(Completed)

This is a multicenter, observational study in adult participants undergoing different types of elective surgical procedures requiring general anesthesia. During the first study period, there will be a cross-sectional evaluation of neuromuscular blockade level upon participant arrival at Post Anesthesia Care Units (PACUs). During the second study period, hospital discharge data from the participants will be collected. The purpose of this study is to determine the incidence of incomplete postoperative neuromuscular recovery from anesthesia at PACUs in Portuguese hospitals. This is a cross-sectional and retrospective study.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Informed consent signed
* Admission for elective surgery
* Administration of nondepolarizing NMBAs during surgery

Exclusion Criteria:

* Admission for emergency surgery
* Reoperation on the same hospital admission
Early Onset Alzheimer's Disease Genomic Study

The purpose of this study is to collect samples from patients with Early-Onset Alzheimer's disease (AD) and their immediate family members for molecular analysis. Samples will be studied in order to understand how molecular changes in the body are related to the development of the disease. Researchers will study your DNA and RNA in order to help doctors diagnose, treat, and monitor people at risk of developing Early-Onset AD in the future.

About 50 people will be asked to take part in this study at this location. This will include participants with early-onset AD and their parents and siblings. Participants will be asked to: Sign this consent form or have a Legally Authorized Representative sign and provide the participant' health history. The study staff will review the participant's medical history and test results to see if the participant can be part of this study, The study staff will need to know any over-the-counter or prescription drugs, vitamins, or herbs taken by the participant. The study staff will discuss what is required to be part of this study. Participants cannot take part in this study if they have: Family history of early or late-onset Alzheimer's disease, Uncontrolled concurrent illness including psychiatric illness or situations that would limit compliance with the study requirements or the ability to willingly give written or verbal consent. If the participant agrees to take part in this study, one 8mL blood sample (about 2 teaspoons) will be collected from them. If the participant is receiving a clinically indicated blood draw, the blood collections for this study will occur at the same time. Participants may be required to have a research-specific blood draw if they are not scheduled for a blood draw during a regularly scheduled visit.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of early-onset Alzheimer's disease based on the NIA-AA diagnostic criteria as determined by the clinician. (Those patients with severe dementia due to Alzheimer's disease or who have impaired decisional capacity, may participate only if their legally authorized representative gives their consent.)
* Male and female patients ≥40 and ≤65 years of age.
* Parents and siblings of the participant with Alzheimer's disease.

Exclusion Criteria:

* Family history of early or late-onset Alzheimer's disease.
* Uncontrolled concurrent illness including psychiatric illness or situations that would limit compliance with the study requirements or the ability to willingly give written or verbal informed consent