cyrilzakka/clinical-trials huggingface dataset:
Quadruple Versus Sequential Therapy for Helicobacter Pylori Eradication

Helicobacter pylori (HP), a bacterium present in many people's stomachs, is one of the major causes of ulcers and cancers. Up to 20% of patients infected with H. pylori may develop peptic ulcers. However, failure rate is rising due to multiple resistant H. pylori infection. The eradication rate of first line clarithromycin based therapy has fallen to below 80%. Both quadruple and sequential treatment regime has been proposed as the first-line empirical regime. Nevertheless, comparison in terms of efficacy and side effects between the two regime remained unknown. The aim of this clinical trial is to compare the efficacy and tolerability of H. pylori eradication with a 10-day quadruple therapy versus sequential therapy as empirical first and second line treatment.

Helicobacter pylori (HP), a bacterium present in many people's stomachs, is one of the major causes of ulcers and cancers. Up to 20% of patients infected with HP may develop peptic ulcers. However, failure rate is rising due to multiple resistant HP infection. The eradication rate of first line clarithromycin based therapy has fell to below 80% and increasing number of patients also failed the second line quadruple therapy. The aim of this clinical trial is to compare the efficacy and tolerability of H. pylori eradication with a 10-day quadruple therapy versus sequential therapy as empirical first and second line treatment.

Methods: Eligible H. pylori positive patients were randomized to receive either QUAD (esomeprazole 20mg twice daily, bismuth subcitrate 120mg four times daily, tetracycline 500mg four times daily and metronidazole 400mg four times daily) for 10 days or SEQ (esomeprazole 20mg twice daily for 10 days, amoxicillin 1g twice daily for first 5 days, clarithromycin 500mg twice daily and metronidazole 400mg four time daily for the subsequent 5 days). All patients returned 8 weeks after completing the treatment for a Urea Breath Test (UBT) to confirm eradication. Patients who failed their respective therapy were crossover to receive the alternative regimen.

Eligibility Criteria:
Inclusion Criteria:

* patients with age 18 or above, diagnosed to have gastric HP infection

Exclusion Criteria:

* Patients with age less than 18, with past allergy to the study medications, concurrent critical illnesses, a history of previous upper gastrointestinal surgery, intake of nonsteroidal anti-inflammatory drugs, antibiotics, probiotics, bismuth preparation, proton pump inhibitors, anticoagulants or steroids in the previous one month, pregnant or breast-feeding women, drug abusers or alcoholic, history of previous H. Pylori treatment
Use of Mobile Technology for Intensive Training in Medication Management

Purpose: Assess whether intensive training with education and daily remote monitoring with provider involvement has a lasting positive impact on adherence to medication management. The study will seek to enroll 25 subjects with sickle cell disease or thalassemia, and less than 100% compliance for taking iron chelators in the previous three month prior to participation in the study. Subjects will be asked to monitor their daily iron chelator administration by taking a video recording of preparing it and ingesting at least one sip. Subjects will also use a medication log to record daily administration of medication, and meet with study staff monthly for educational activities. The data collected will be analyzed to describe patient adherence and comfort level with the process of daily recording of medication management. Mean percent adherence in the pre-study periods and each of the study periods will be analyzed and compared.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of sickle cell or thalassemia
* History of iron overload

Exclusion Criteria:

* None
A Pilot Trial of Patient Decision Aids for Implantable Cardioverter-Defibrillators (ICDs)

The purpose of this study is to test the acceptability and feasibility of a "toolkit" of patient decision aids (PtDAs) for heart failure patients who are considering an ICD implant.

Specific Aim 1: Examine acceptability and feasibility of a toolkit of patient decision aids (PtDAs) for patients with heart failure referred for primary prevention implantable cardioverter-defibrillators using a randomized control trial design across three diverse health care systems (Kaiser Colorado, The University of Colorado, and The Denver Veterans Hospital).

1. Measure the acceptability of the decision aids
2. Explore feasibility by measuring patient participation rates and adherence to the study protocol across all three sites.
3. Conduct a preliminary assessment of outcomes by measuring changes in decision quality (knowledge and value concordance), quality of life, depressive symptoms, health status, and spiritual well-being.

Specific Aim 2: Determine the relative value of the various tools in the toolkit through in-depth interviews from study participants and providers at each intervention site

Eligibility Criteria:
Inclusion Criteria:

* systolic heart failure (defined as an ejection fraction less than 35%)
* have been referred for a primary prevention ICD
* Note: Patients referred for an ICD with cardiac resynchronization therapy are NOT excluded.

Exclusion Criteria:

* Already have an ICD
* Non-English speaking (as the tools we have developed are only available in English currently)
* Other ICD indications (e.g. secondary prevention, hypertrophic obstructive cardiomyopathy)
* Cognitive Impairment defined only as people with an inability to consent
Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers

The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers


Eligibility Criteria:
Inclusion Criteria:

* healthy normal, soft contact lens wearing volunteers
* normal ocular health
* contact lens correction from +6.00 to -12.00D in each eye and astigmatism of -1.00D or less in each eye

Exclusion Criteria:

* active ocular infection
* history of ocular surgery
* use of topical ophthalmic preparations (including rewetting drops)
* pregnancy or lactation
Feasibility of MRI Workflow Alone in External Radiotherapy for the Treatment of Brain and Prostate Tumors

In radiotherapy, Magnetic Resonance Imaging (MRI) is used as a complement to the CT scanner because it provides better tissue contrast and therefore more precise delineations without the need for additional irradiation. However, MRI does not allow the definition of the electronic densities of the tissues necessary for dose calculation.

In this work, we sought to measure the feasibility of a method for generating CT-synthetic images from MRI in terms of dosimetric and geometrical precision for the purpose of MRI workflow alone (see diagram). The cerebral sphere and the prostate are the two tumor locations considered. All patients will have a planning CT (reference) and an MRI in the treatment position. The contours of the structures will be contoured by a radiotherapist on both the MRI and the reference CT. Synthetic CTs will be generated from the MRI with the method of automatic assignment of densities in five classes. The volumes bypassed and the dosimetries performed will be compared. A study of the quality of the images generated from MRI for dose calculation and images for the verification of per-treatment positioning will be performed.

This is a prospective single-center dosimetry study that exhaustively included brain tumor and prostate cancer patients treated at the ICO Site d'Angers by external radiotherapy and prior to which they were given an MRI and a simulation CT in treatment position over a 12-month period.

For patients who agree to participate in the study, CT-synthetic images will be generated from the MRI images by automatic assignment of densities (5 classes).

Reference CT images from CT and synthetic CT images from MRI will be available for comparison for all eligible patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Male or Female with a (primary) brain tumour or Male with cancer and localized (non-metastatic) prostate cancer
3. Patient having benefited from a planning MRI scan in treatment position performed according to the new acquisition modalities (allowing the generation of CT-synthetics by automatic assignment of densities) performed since January 2020 and a planning scanner in treatment position prior to external radiotherapy.
4. Good general condition (SP \< 3)

Exclusion Criteria:

1. Excluded forms of the disease,
2. MRI-specific contraindications (claustrophobia, foreign bodies)
3. Obesity preventing the placement of equipment (contention/antennae)
4. Poor general condition (SP \> or = 2) preventing the patient from standing on the table -
Effects of Post-activation Performance Enhancement Protocols on Judo-specific Performance: a Randomized Crossover Trial

The study aimed to investigate the post-activation performance enhancement (PAPE) of the special judo fitness test (SJFT) of youth judo athletes using upper-body (isometric push-ups), lower-body (standing broad jumps), or their combination as conditioning exercise (CE).

Fourteen females (aged 16.5 ± 0.8 yrs) and nine males (aged 17.0 ± 0.9 yrs) performed the three CEs or a control condition (i.e., judo-specific warm-up) in a randomized crossover method. The SJFT was conducted one minute after the CE or control condition.

Eligibility Criteria:
Inclusion Criteria:

* Minimum of 4 years of judo training and competition experience.
* Actively practicing the sport and preparing for a competition during the time of data collection
* Proficient at performing the ippon seoi-nage throwing (judo) technique

Exclusion Criteria:

* Disease or serious injury that inhibited participating in the warm-up protocols and subsequent testing sessions.
LifeVest Post-CABG Registry

This is a multi-center prospective registry of patients with an ejection fraction (EF) ≤ 35% following coronary artery bypass graft (CABG) surgery in order to test the hypothesis that wearable defibrillators (WD) will decrease overall mortality after discharge by decreasing arrhythmic death in this select population with high risk for sudden cardiac death (SCD). This is a pilot project to determine the feasibility of a larger-scale study.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone CABG surgery during current hospitalization
* Patients who have an ejection fraction ≤ 35% following the surgery.
* Patients who have dilated cardiomyopathy or prior myocardial infarction.
* Patients who are prescribed a wearable defibrillator following surgery.
* Patient who are at least 18 years old.

Exclusion Criteria:

* Patients who have an active ICD.
* Patients who have an active unipolar pacemaker.
* Patients having a chest circumference over 56 inches or under 26 inches.
* Patients who are unable to consent or unwilling to wear the WCD after discharge or who do not agree to be contacted at 90 days.
* Patients with a mental, visual, physical or auditory deficit that could impair their ability to properly interact with a wearable defibrillator.
* Patients participating in another clinical study with mortality as the primary endpoint.
* Patients unable to use a wearable defibrillator due to physical conditions (bandages preventing electrode contact, physical deformities preventing electrode contact, dextrocardia, etc.).
* Patients who have decided to forgo resuscitation.
The Oil, Fats and Oleogel Study

The aim of this study is to compare the effects of dietary fats, ingested in two physical forms, on acute energy balance, appetitive, and glycemic responses of healthy normal (BMI 18-24.9 kgm-2) or overweight (BMI\>25kgm-2) adults.

This will be a randomised, crossover study. Randomisation will be performed with an online randomisation software (www.randomizer.org). Participants will be screened (1 screening visit) and attend five test visits conducted in a whole room calorimeter (WRC). During each test visit, participants will arrive at the laboratory after an overnight fast, enter the WRC and rest for 15 minutes in a supine position,have their resting energy expenditure (REE) measured for 30 minutes and consume congee and juice alone(control), or with one of the 4 dietary fats: sunflower oil (SO) or gel (SG) and coconut oil (CO) or gel (CG) (total 5 test visits). Post-meal energy expenditure, fat oxidation, glycemia and appetite (visual analog scales) will be measured continuously for 3 hours in WRC, followed by a meal challenge where participants will eat until sated. Participants will return and repeat the protocol until all fat types and forms are completed.

Eligibility Criteria:
Exclusion Criteria:

* People with major chronic disease such as heart disease, cancer, hypertension or diabetes mellitus
* People with known food allergies, due to potential traces of allergens found in the commercially available food product used in our study (Knorr's instant congee)
* People who are claustrophobic
* Individuals who are taking insulin or drugs known to affect glucose metabolism, appetite, and body fat distribution
* Have weight change of \>5kg in the past 3 months
* People with a major medical or surgical event requiring hospitalization within the preceding three months
* People who are on a weight loss regime
* Individuals with the presence of disease or drugs which influence digestion and absorption of nutrients
Effects of Sensorimotor and Core Stabilization Exercises After Total Knee Arthroplasty

Tha aim of the study is to investigate the effects of core stabilization and sensorimotor exercise program on range of motion, proprioception, balance and functional status in patients with total knee arthroplasty. The study lasts prospective randomized controlled trial. Participants were randomly divided into sensorimotor training (SM,n=17) and core stabilization training group (CS,n=19). The exercise training program was administered for home exercise as 3-5 times a week and for a 6-week duration.

Objective :

To investigate the effects of core stabilization and sensorimotor exercise program on range of motion, proprioception, balance and functional status in patients with total knee arthroplasty.

Design :

Prospective randomized controlled trial

Subjects :

A total of 36 Ostearthritis patients (69.8 ± 5.1 years) who underwent unilateral knee arthroplasty. Participants were performed TKA surgery by the same physician and followed by the same therapist.

The following inclusion criteria were used: being volunteer, 50-85 age range, being diagnosed with stage 4 OA and undergoing unilateral TKA surgery. The following exclusion criteria were applied: having previous surgery history of affected lower limb, impaired hearing, vision or verbal problems, physical or mental disability, having a neurological or oncologic disease that may affect functional performance.

Patients who met inclusion criteria and were willing to join the study (n=52) were evaluated after being diagnosed with OA and before the operation at the clinic. A total 40 patients undergoing TKA surgery participated in our study and were randomly separated to the Sensorimotor Training Group (SM, n=20) and the Core Stabilization Training Group (CS, n=20). Group allocation was randomized in two blocks of 40 sealed envelopes without external marks, which were mixed and numbered from 1 to 40, containing a piece of paper with the group allocation. All participants were blinded to the treatment type. As a result, 36 patients completed the process.

Outcome Measures :

Patients were assessed on three separate occasions (presurgery, 2 weeks and 8 weeks postsurgery). The primary outcome was proprioception and seconder outcomes were range of motion, Knee Injury and Osteoarthritis Outcome Scale (KOOS), Berg Balance Test, Timed-up \& Go test and Sit \& Stand -Up tests.

Interventions :

Participants were randomized into two intervention groups: sensorimotor training group (SM, n=17) and Core Stabilization training group (CS, n=19). Both groups were prescribed a 6-week home based exercise programme for 3-5 sessions/week between 2 and 8 weeks postsurgery.

Eligibility Criteria:
Inclusion Criteria:

* being volunteer,
* 50-85 age range,
* being diagnosed with unilateral OA and undergoing unilateral TKA surgery

Exclusion Criteria:

* having previous surgery history of lower limbs,
* impaired hearing-vision -verbal problems, physical or mental disability,
* having a neurological or oncologic disease that may affect functional performance.
Trial Investigating the Safety of NNC 0113-0987 in Healthy Male Subjects

This trial is conducted in Europe. The aim of this trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single doses of NNC 0113-0987 in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects with good general health as judged by the investigator, based on medical history, physical examination including 12-lead electrocardiogram (ECG), vital signs, and blood and urinary laboratory assessments at the screening visit
* Body Mass Index (BMI) of minimum 18.5 and below 30 kg/m\^2

Exclusion Criteria:

* Male subjects who are sexually active and not surgically sterilised, who or whose partner are unwilling to use two different forms of effective contraception, one of which has to be a barrier method (e.g. condom with spermicidal foam/gel/film/cream) for the duration of the trial and for 3 months following the last dose of trial medication
* The receipt of any investigational product within 90 days (or 5 half-lives of investigational drug, whichever is greater) prior to this trial (screening), or is currently enrolled in any other clinical trial
* Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the current trial, as judged by the investigator
* Subjects who are known to have hepatitis or who are carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or have a positive result to the test for Human Immunodeficiency Virus (HIV) antibodies
* History of chronic or idiopathic acute pancreatitis or amylase or lipase values above 3x upper normal range (UNR)
MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma

This is a Phase 2 single arm study to evaluate efficacy and safety of Pembrolizumab before with BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab Q3week starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for autologous stem cell transplant (ASCT) with BEAM conditioning regimen
* KPS greater than 70 or ECOG ≤ 1
* Adequate organ function and blood counts within 14 days of study registration
* Participants who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
* Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.
* HIV-infected participants must have well-controlled HIV on ART

Exclusion Criteria:

* Patients with prior history of autoimmune reaction to PD-1 inhibitors greater than or equal to grade 3.
* Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.
* Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
* Has received any chemotherapy within 3 weeks prior to the first dose of study intervention
* Has known active CNS disease.
* History of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents. Exceptions: Participants with vitiligo, resolved childhood asthma or atopy, hypothyroidism, or Sjogren's syndrome, as well as participants requiring only intranasal steroids, intermittent use of bronchodilators, local steroid injections, or physiologic replacement doses of prednisone (≤ 10 mg/d) may enroll.
* Has had an allogenic tissue/solid organ transplant.
* Pregnant or breastfeeding as agents used in this study are Pregnancy Category D (positive evidence of risk). Females of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days of study registration
A Prediction Model for Chronic Ankle Instability

Chronic ankle instability is a common problem that may follow an ankle sprain. Until a patient has developed chronic ankle instability they are ineligible for surgical treatment although early surgical treatment yields better results compared to surgical treatment of subjects that have experienced recurrent ankle sprains. However, treating all patients with an ankle sprain surgically is not an option due to the high amount of unnecessary invasive interventions.

The objective of this study is to identify which patients will develop chronic ankle instability and to develop a model to predict which patients should receive early surgical treatment.

In this prospective observational cohort all patients (older than 18 years) that report at the emergency department of the participating hospitals after a lateral ankle sprain, of whom an x-ray is made after positive Ottawa Ankle Rules and on which there is no visible fracture or other pathology.

The main study parameter is a significant difference in patient characteristics, foot and ankle configuration and joint pathology between patients who develop chronic ankle instability and patients who do not experience recurrent ankle sprains and restriction during daily live after an initial sprain.


Eligibility Criteria:
Inclusion Criteria:

* At least 16 years old
* Visited the ER within one week after a lateral ankle sprain
* An anteroposterior and lateral x-ray have been made
* Agreed with being approached for this study
* Questionnaires have been returned within 4 weeks
* Reported lateral ankle pain after an ankle sprain or ankle distortion ankle

Exclusion Criteria:

* Present fracture or other joint pathology/bone matrix pathology
* A diagnosed osteochondral defect after primary inclusion
* Medial ankle instability
* Previous ankle surgery
* An unreliable x-ray due to the angle in which it is made or low quality
* Acute surgical repair of the anterior talofibular ligament and/or calcaneofibular ligament or another form of surgery within 6 months after the initial ankle sprain
The Short Physical Performance Battery in Chronic Obstructive Pulmonary Disease (COPD)

Patients with COPD often have limitations to physical performance. There are several tests for evaluating physical performance, unfortunately many of them can be time consuming and require specialized equipment an substantial space. Short physical performance battery is a simple test that requires little resources and can be performed both at institutions and in the homes of patients. SPPB has high predictive abilities in identifying older adults at greater risk for mortality, nursing home admission, hospitalization, and incidence of disability. The investigators would like to evaluate possible changes in the SPPB score after a 4-week rehabilitation program. The investigators would also like to look at possible relationships between the SPPB and other physical performance measures, dyspnea, anxiety, depression, fatigue, and health related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients with all stages of COPD
* Decision making capacity to provide informed written consent
* Ability to understand and complete the questionnaires

Exclusion Criteria:

* Exacerbation within the last four weeks
* Co-morbidities that limits the patient's physical performance more than COPD
* Any patient whom is deemed unsafe to exercise
* Patients tested on treadmill protocol 4 (i.e. Glittre testing protocol)