cyrilzakka/clinical-trials huggingface dataset:
Efficacy of 10-day Concomitant Regimen Versus High Dose Dual Therapy in Anti-Helicobacter Pylori Rescue Therapy

Currently, a 10-day concomitant therapy has been reported to be equally effective and safe to the 10-day sequential therapy for 1st-line anti-Helicobacter pylori(H. pylori) therapy. To our knowledge, there has been no report concerning the efficacy of this regimen used as a rescue therapy.

The aims of this study are:

1. to compare the efficacy of high dose dual therapy and concomitant therapy as rescue regimen in H. pylori eradication;
2. to compare the patient adherence and adverse effects of these treatment regimens;
3. to investigate factors that may influence H. pylori eradication by these treatment regimens.

Patients, aged 18, having H. pylori-positive chronic gastritis with/without peptic ulcers will be recruited. All undergo endoscopy with biopsy before treatment. Four to eight weeks after termination of treatment, H. pylori infection status will be examined by endoscopy with biopsy or the Carbon 13-urea breath test if the patients refuse the second endoscopy. The cytochrome P450 (CYP)2C19 genotype of each participant will be analyzed by the polymerase chain reaction-based restriction fragment length polymorphism (PCR-RFLP) method. A computed generated random numbers sequence will be blocked into two subgroups, say A and B.

If the patients had received anti-H. pylori therapy previously, they will be invited to enter the study for evaluating the efficacy of rescue regimens. After giving their written informed consent, all patients will be labeled with numbers by enrolling order. Each patient will be randomly allocated to one of two treatment groups which receives medications for 10 to 14 days:

group A - high dose dual therapy (rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days); group B - concomitant therapy (rabeprazole 20 mg + amoxicillin 1000 mg + metronidazole 500 mg + clarithromycin 500 mg, bid for 10 days).

All patients will be asked to complete a questionnaire and to record symptoms and drug consumption daily in a diary card during the treatment period. Post-treatment, the patients will be seen at the Outpatient Clinic to investigate patient adherence and adverse effects of treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients having H. pylori related chronic gastritis with/without peptic ulcers who are aged greater than 18 years and are willing to received eradication therapy.

Exclusion Criteria:

* pregnant or nursing woman
* serious concomitant illness and malignant tumor of any kind
* history of hypersensitivity to test drugs
* serious bleeding during the course of this ulcer
* previous gastric surgery
* receiving bismuth salts, proton pump inhibitors, or antibiotics in the previous month.
Effect of a Micro-finance-based Intervention for the Prevention of Intimate-partner Violence and HIV

The high rates of HIV infection in women have brought into sharp focus the problem of violence against women. There is a growing recognition that women and girls' risk of and vulnerability to HIV infection is shaped by deep-rooted and pervasive gender inequalities violence against them in particular. The links between intimate partner violence and HIV/AIDS are explained by biological as well as sociocultural and economic factors.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old;
* Must plan to reside in study areas for the next 12 months
* Must visit camp at least 1 time per week
* Must provide contact information of friend or family member

Exclusion Criteria:

* Unwilling to provide local information
* Psychological disturbance, cognitive impairment or threatening behavior
NCCN Renal Cell Registry

This study will consist of three parts: 1) a retrospective chart review of patients treated for mRCC from July 2013 until the start of the educational intervention; 2) an educational program for DCN community oncology providers and DCN community patients with mRCC, lasting 8 - 10 months, and 3) a second retrospective chart review of patients treated for mRCC starting at the time of the educational intervention until the intervention is completed.

The initial retrospective cohort will serve as the pre-education control, and the second cohort will be the experimental group to assess the efficacy of the educational intervention to change care of patients with mRCC.

Chart Reviews. This study will begin with a multi-site chart review conducted at the Duke Cancer Network affiliated sites. The chart review will begin in late fall, 2015. The Duke Cancer Network team will perform chart abstraction for this study, with a goal of reviewing at least 60 charts of patients treated between July 2013 and October 2015.

The second data collection period will collect data on patients with mRCC seen at DCN sites after the date in fall 2015 when the educational intervention is rolled out. The target will again be at least 60 charts of patients treated during the time the educational intervention is actively available.

Eligibility Criteria:
Inclusion Criteria:

* Oncology providers (physicians, nurse practitioners, physicians' assistants) at DCN affiliated sites will be invited to use the performance support system and participate in the online virtual tumor boards for CME credit.

Exclusion Criteria:

* Non DCN affiliated sites providers
Advanced Understanding of Staphylococcus Aureus Infections in Europe - Surgical Site Infections

ASPIRE-SSI is a prospective, observational, multicentre cohort study among adult surgical patients, which aims to determine the incidence of healthcare-associated S. aureus infections, particularly S. aureus surgical site infections (SSIs), across Europe and to assess the most important risk factors for this type of infection.

The primary objective of ASPIRE-SSI is to determine the incidence of S. aureus infections, particularly S. aureus SSIs, in various adult surgical patient populations, and to identify the patient-related, pathogen-related, and contextual risk factors for the development of S. aureus SSI. Using this information, a SSI prediction tool will be derived for future clinical trials and public health interventions aimed at SSI prevention. Furthermore, immunologic features protective against S. aureus SSI will also be assessed.

The knowledge obtained by this study will enable identification of the surgical patients most at risk of developing S. aureus infections, particularly S. aureus SSI, and who would probably benefit most from new interventions given prophylactically and specifically to prevent S. aureus infections.

Eligibility Criteria:
Inclusion Criteria:

* The subject is 18 years of age or older.
* The subject is undergoing 1 of the protocol-defined surgical procedures. The surgical procedure is planned or unplanned.
* The subject has been screened for S. aureus colonization from three body regions: nose, throat, and perineum within 30 days prior to surgery, and based on the preoperative S. aureus colonization status of the subject, the subject qualifies for enrolment in the study cohort.
* Written informed consent has been obtained prior to enrollment in the study cohort.

Exclusion criteria:

* Parallel participation in any experimental study of an anti-Staphylococcus preventive intervention.
* An active diagnosis of a SSI as the reason for surgery.
* Not able to comply with study procedures and follow-up based on Investigator judgment.
Quantification of Arm Non-Use After a Stroke

Reproducibility assessment of a quantitative measure of the amount of trunk compensation by kinematic analysis in a grasping task in stroke patients.This "maladaptive trunk compensation" is suspected to be underlined by "arm non-use" in some patients, since this abnormal movement impairs the ability of patients to correctly flex their shoulder and extend their elbow during grasping.


Eligibility Criteria:
Inclusion Criteria:

* · Patient hemiparetic

  * Hemiplegic Patient
  * Patient can perform a global task with the gripping limb

Exclusion Criteria:

* Patient can not actively tender elbow of the affected limb,

  * Patient who can not actively flex the shoulder of the affected limb,
  * Patient with a passive extension deficit elbow\> 30 °,
  * Patient with a shoulder flexion passive deficit\> 60 °,
  * Patient with severe neglect
  * Patient bearer severe cognitive impairment
  * A patient with aphasia understanding disorders
Prospective System Analysis of the Seasonal Influenza Virus Transmissions and Evolution in the City of Basel Basel

The project aims to use epidemiological tools to understand the transmission and evolution of influenza viruses at an individual and population level within a small-scale city (Basel) through a combination of experimental, clinical, and mathematical advances. Investigators aim to quantitatively characterize the viral transmission using novel molecular-epidemiological tools based on whole genome sequencing.

Samples will be collected such as whole blood, serum and DNA, nasopharyngeal swamps to diagnose influenza by polymerase chain reaction (PCR) and to determine colonization rates with Staphylococcus aureus and Streptococcus pneumonia. All samples except the first naso-pharyngeal swab for influenza diagnostics will be stored in a biobank and analysed in batches. Each influenza virus isolate will be sequenced using a "whole genome sequencing" approach. The viral transmission and evolution will be analysed using whole genome data for a detailed molecular and phylogenetic tree analysis, respectively. The epidemiological and geographical data will be incorporated into the phylogenetic model.

Eligibility Criteria:
Inclusion Criteria:

* Each pediatric or adult patient, which fulfill the World Health Organization (WHO) definition of Influenza like illness.
* The case definition includes an acute respiratory infection with coughing, fever ≥38°C, and start of symptoms within the last 10 days.
* Presentation of the patient with influenza-like illness on the emergency ward of the University Hospital Basel or the University Children Hospital of both Basel or a collaborating private practise.

Exclusion Criteria:

- Case definition for influenza like illness is not fulfilled
Swiss National Iodine Survey 2015

The aim of this study is to monitor iodine nutrition in Switzerland in order to inform the authorities regarding iodine content in iodized salt. As a proxy for the entire population the investigators will study school aged children, pregnant women and women of reproduction age.

In a national sample of school aged children (n=990), pregnant women (n=700) and women of reproductive age (n=700) urinary iodine will be determined in order to assess iodine nutrition in Switzerland. In addition, in both groups of women a blood sample will be taken for the determination of thyroid hormones, iron- and folate status. Questionnaires will be used for the determination of dietary iodine and salt intake as well as sociodemographic parameters.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Living in Switzerland for at least 1 year
* For pregnant women: singleton pregnancy

Exclusion Criteria:

* Major known medical illness: thyroid dysfunction, gastrointestinal or metabolic disorders and taking chronic medications
* For women of reproductive age: pregnancy, breastfeeding
* Use of X-ray or CT contrast agent or iodine containing medication within the past year
Influence of Intrathecal Dexamethasone Administration for Proximal Femoral Fractures

Spinal anesthesia blocks acute pain in older patients with femur fracture. Delirium is a common complication seen after femur fracture, affecting approximately 10-16% of patients. It is associated with increased mortality at 1st year, delayed rehabilitation efforts, prolonged length of hospital stay, poorer functional outcomes, and increased risk of nursing home placement.

Intrathecal dexamethasone administration improves quality of anesthesia in patients with femur fracture compared to conventional spinal anesthesia.

The aim of this research was to establish the influence of intrathecal dexamethasone administration in spinal anaesthesia with levobupivacaine on postoperative pain and changes of consciousness, values of cortisol levels and quality of treatment for patients with femoral fractures compared to spinal anaesthesia with only local anaesthetic.

The study was planned as a prospective, observational, randomised clinical trial. A total of 60 patients ASA2 and ASA3 status, scheduled for surgical procedures were sorted into two groups and underwent surgery in spinal anesthesia with levobupivacaine with or without dexamethsone.

Eligibility Criteria:
Inclusion Criteria:

* cooperative ASA 2 and ASA 3 status patients with proximal femoral fractures of one leg
* agreed to be enrolled in the study (Informed Consent signed)

Exclusion Criteria:

* patients refused to be enrolled in the study
* patients with pre-existing cognitive disturbances before surgery
* conditions or diseases with corticosteroid therapy, long term corticosteroid, diabetes mellitus, neurological conditions or tumors, neuroendocrine disorders or tumors
* breaking the study protocols
* patients who no longer wanted to be enrolled in the study
* unexpected events when the study already started
Effects of Whey Protein and Collagen Supplementation

The present project aims to investigate the effects of high-quality protein (whey protein) vs. low-quality protein (collagen) on muscle mass and function (e.g., strength and power) during a 10-wk resistance training program in young adults. It will be tested the hypothesis that leucine-matched collagen should promote similar gains on muscle function and mass compared to whey protein supplementation.

The purpose of this study will be to investigate the effects of whey protein vs. leucine-matched collagen supplementation on muscle mass and function after a 10-wk resistance training program. Initially, all participants will be submitted for a 2-wk familiarization period, and then randomized into two groups (N = 11 / group): whey protein group and leucine-matched collagen group. The following variables will be assessed from pre-to post-training: anthropometric, muscle thickness from vastus lateralis and biceps brachii muscles using ultrasound, training load, mean power and peak torque for unilateral arm flexion exercise using a isokinetic dynamometer, countermovement vertical jump, nutritional intake, and testosterone-to-cortisol ratio . Shapiro-Wilk and Levine tests will be used to test the normality and homogeneity of the measurements, respectively. Two-way ANOVA (group x time) tests for repeated measures will be performed to assess changes over time and between groups for all dependent variables. Violation of sphericity will adjust using Greenhouse- Geyser correction. The Bonferroni post-hoc test will detect specific differences between groups. When appropriate, the percentage of change (∆%) will be reported according to the following equation: ∆% = \[(pre-average post average) / pre-average mean\] × 100. Values will be express as mean ± standard deviation. O significance level α will be 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18-35 years
* To be eutrophic (not overweight or obese)

Exclusion Criteria:

* To present a history of musculoskeletal disorders
* Be attending a systematized weight training program for at least six months
* To make use of medicines that could affect muscle function.
* To have used ergogenic supplements and anabolic steroids for at least six months before study
* To have restrictions for exercises practice considering Physical Activity Readiness Questionnaire (PAR-Q) responses.
A Study to Investigate the Efficacy and Safety of MS-553 in CLL/SLL

This is a Phase I/II, single arm, multi-center, open-label clinical trial of MS-553 in patients with CLL/SLL whose disease relapsed after or was refractory to at lease 1 prior therapy (chemotherapy and/or targeted drug therapy, which must include BTK inhibitor therapy) and who are indicated for treatment per IWCLL2018.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older, male or female.
* Diagnosis of CLL/SLL per IWCLL2018 criteria.
* Patients with relapsed or refractory CLL/SLL who have failed at least 1 prior therapy (chemotherapy and/or targeted drug therapy, which must include BTK inhibitor therapy), are indicated for treatment per IWCLL2018.
* Measurable lesions detected by contrast-enhanced computed tomography (CT): at least one lymph node with a maximum axis of more than 1.5 cm and one measurable vertical dimension.
* WHO/ECOG performance status of 0 to 2.
* Patients with an estimated survival of more than 3 months.

Exclusion Criteria:

* Biopsy-proven and pathologically confirmed current or past transformation to Richter's syndrome.
* Patients with active and uncontrolled autoimmune cytopenia, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura.
* Patients who have received any of the following treatments within 14 days prior to the first dose:

  * Major surgery;
  * Glucocorticoids (at a dose equal to or greater than 20 mg/day prednisone or equivalent), unless used by inhalation, topical or intraarticular route, or unless necessary for premedication before and after iodinated contrast dye. After discussion with the Sponsor, steroid therapy at high doses for an extended period may be allowed under the following circumstances:

    1. Treatment of autoimmune hemolysis or autoimmune thrombocytopenia associated with CLL/SLL;
    2. Short-term (within 14 days) use to treat inactive infections of diseases unrelated to CLL/SLL (e.g. arthritis, asthma), which results in acute exacerbation, including steroid dose modifications required for adrenal insufficiency;
  * Cytotoxic chemotherapy or biologic therapy, excepting BCR pathway kinase inhibitors for which a washout of 24 hours prior to the first dose is required.
* Toxicity from prior anti-tumor therapy (chemotherapy, radiotherapy, or biotherapy) did not restore to ≤ Grade 1 (except for alopecia); atrial fibrillation from prior treatment with BTK inhibitors did not restore to ≤ Grade 2.
* Central nervous system (CNS) leukemia or lymphoma, including a history of asymptomatic, previously treated CNS disease.
Condensed Digital Prolonged Exposure for Individuals Treated Within Somatic Trauma Care.

The purpose of the study is to investigate the feasibility of implementation aspects, treatment effects and change processes regarding a brief trauma-focused Internet-based CBT treatment, for patients who have been treated in trauma care at Karolinska University Hospital and who exhibit symptoms of psychological consequences of the traumatic event. Another aim is to explore factors (predictors, moderators and mediators) that influence the effect of the treatment, in order to better understand who responds to the treatment.

The study is un-controlled with 250 participants that will undergo a brief trauma-focused Internet-based CBT treatment, delivered as a three-week treatment comprising of four modules (psychoeducation/rational, in vivo exposure, imaginal exposure and relapse prevention). The primary outcome is the PCL-5. Secondary outcomes are level of depression (PHQ-9), quality of life (WSAS) and predictors, moderators and mediators of clinically meaningful change in symptoms, dropout rate, rates of inclusion, attrition, adherence,and negative effects.

Self-reported, qualitative data from participants will be gathered at treatment completion to capture participants' experiences of participating in the intervention, as well as their views on how to further improve the intervention. The treatment effects will be evaluated using a within-group design with repeated measurements. Participants in the study will be will recruited from patients treated in the somatic trauma care at the Karolinska University Hospital in Stockholm, Sweden.

Eligibility Criteria:
Inclusion Criteria:

* Exposed to trauma in the past two months according to criterion A for PTSD in the DSM-5 (exposed to death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence).
* PCL-5 total sum score\>10
* ≥ 18 years
* Situated in Sweden
* Signed informed consent

Exclusion Criteria:

* Other serious comorbidity as primary concern (ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, borderline personality disorder, high suicidal risk according to the MINI)
* Unable to read and write in Swedish
* Receiving other psychological trauma-focused treatment
* Ongoing trauma-related threat (e.g., living with a violent spouse)
* Not stable dose of antidepressant medication the last two weeks
A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)

The primary objectives of this study are to:

* estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-tetanus response at Week 24
* estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-meningococcal response at Week 24


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years to 54 years with a diagnosis of AD according to the American Academy of Dermatology (AAD) Consensus Criteria (2014) present for at least 12 months
* History of inadequate response to topical corticosteroids (TCS) of medium, high, or higher potency (with or without topical calcineurin inhibitors)
* Subjects with previous systemic treatment for AD are also considered as inadequate responders to topical treatments and are potentially eligible to be included in the study after appropriate washout.
* Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score ≥ 3

Exclusion Criteria:

* Treatment with a biologic product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1
* Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:

  * Systemic corticosteroids
  * Systemic immunosuppressants
  * Phototherapy
  * Janus kinase inhibitors
* Treatment with any of the following medications or therapies within 1 week, prior to Day 1:

  * TCS of any potency
  * Topical calcineurin inhibitors (TCI)
  * Topical Phosphodiesterase-4 inhibitors (PDE4)
  * Other topical immunosuppressive agents
  * Combination topical agents containing a corticosteroid or calcineurin inhibiting component, PDE4 inhibitors, or other topical immunosuppressive agents
* Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 pre-randomization.
* Treatment with any meningococcal vaccine within 1 year prior to screening, or treatment with any tetanus-, diphtheria-, or pertussis containing vaccine within 5 years prior to screening
Probiotic Intervention for Acute Stress

Efficacy of probiotics on acute stress


Eligibility Criteria:
Inclusion Criteria:

* 19-35 years
* SMBQ-score ≥3.75
* Understand Swedish in spoken and written terms
* Willing and able to give written informed consent for participating in the study
* Intake of probiotics within two weeks prior to the start of the study

Exclusion Criteria:

* BMI\> 30
* Pregnant
* Antibiotic treatment in the last three months
* Known disease (diabetes, pulmonary or cardiovascular disease, celiac disease, thyroid problems, gastrointestinal disease) or mental illness
* Use of psychotropic drugs, beta blockers, asthma or rheumatoid arthritis drugs, steroid drugs or local steroid treatment