cyrilzakka/clinical-trials huggingface dataset:
A Multi-center Study for Eradication of Helicobacter Pylori With Triple Therapy Using Clarithromycin

As the resistant rate of the Helicobacter pylori to some common antibiotics was rising，the eradication rate of the Helicobacter pylori with the standard triple therapy failed to exceed 70% in China，and had to drop out of the first-line treatment recommendations. However, with the increase of treatment time, patients burden, adverse reactions of antibiotics or proton pump inhibitor (PPI) will also increase. Resistance to clarithromycin is the major cause of the failure to eradicate Helicobacter pylori. But, in terms of population, there are still more than 70% of the patients with clarithromycin sensitive. Under the guidance with susceptibility test，7-day standard triple therapy could be used. In this study, investigators will select the patients with infection of H. pylori and with clarithromycin sensitive. Eradication of Helicobacter pylori with triple therapy based on accurate susceptibility testing of clarithromycin will be studied. The treatment time will be assigned into 7 days,10 days and 14 days groups. Then, investigators will perform a sequencing for failed treatment patients in groups, such as drug resistance gene mutation, phenotype and genotype. Finally, investigators will compare the differences between the patients with triple therapy and traditional quadruple therapy.The incidence of adverse effects in the eradicate treatment will reduce at least 10% and avoid patients' unnecessary economic losses at least 400RMB per person.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18\~70 years old, male or female, the first eradication therapy of H. pylori infection patients.
2. Symptoms of abdominal pain, bloating, acid efflux, belching, nausea, vomiting, heartburn, chest pain, vomiting, melena, etc.
3. Unused antibiotics, bismuth, H2 receptor antagonists or PPI by nearly 4 weeks
4. 13C-labelled urea breath test positive.
5. Agreed to Helicobacter pylori culture and sensitivity testing taken by endoscopy gastric biopsy specimens,and the result of culture was positive.
6. Agreed to Helicobacter pylori eradication therapy and cooperate with the eradication efficacy follow-up survey.

Exclusion Criteria:

1. Severe heart, liver, kidney dysfunction.
2. Pregnant or lactating women.
3. Complications of bleeding, perforation, pyloric obstruction, cancer.
4. Within 3 months before with the drugs involved in other drugs research.
5. Esophageal,gastrointestinal surgery history.
6. Patients can not properly express their complaints,such as psychosis, severe neurosis.
7. Taking NSIAD or alcohol abusers.
8. Allergic to amoxicillin or clarithromycin tested by susceptibility testing.
A Study of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults

The purpose of this Phase 1/2 study is to generate sufficient safety and immunogenicity data of mRNA-1018 pandemic influenza candidate vaccines in healthy adults ≥18 years of age to enable the initiation of a large Phase 3 trial with one selected vaccine candidate. The study will be conducted in 2 Parts (Part A and Part B) that will enroll and run concurrently. Part A of the study will evaluate 4 vaccine candidates (H5N8, H7N9, H5 only, and H7 only). Part B of the study will evaluate a single vaccine candidate (H5 only-CG).


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and results of electrocardiogram testing.
* Body mass index of 18 kilograms (kg)/square meter (m\^2) to 39 kg/m\^2 (inclusive) at the Screening visit.
* For female participants of childbearing potential: negative pregnancy test, adequate contraception, and not currently breastfeeding.

Key Exclusion Criteria:

* Participant is acutely ill or febrile (body temperature ≥ 38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) 72 hours prior to or at the Screening Visit or Day 1.
* History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
* Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
* Participant has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 180 days prior to Screening Visit (for corticosteroids ≥10 milligrams \[mg\]/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
* Participant has received any vaccine authorized or approved by local health agency including mRNA vaccine ≤28 days prior to study intervention (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after the study intervention.
* Participant has participated in an interventional clinical study within 28 days prior to the Screening visit based on the medical history interview or plans to do so while participating in this study.

Other inclusion/exclusion criteria may apply.
HMB Cerebral Palsy Pilot Study

This is a pilot study of β-hydroxy-β-methylbutyrate (HMB) + Vitamin D3 supplementation in adolescents with cerebral palsy. The primary objective is to quantify safety, compliance, and acceptability of daily combined HMB + Vitamin D3 supplementation for 12 weeks in adolescents with CP. The secondary objective is to quantify changes in lower extremity muscle mass, strength, and functional mobility after daily combined HMB + Vitamin D3 supplementation for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cerebral palsy
* Spastic or mixed tone
* GMFCS Level I-III (i.e., ambulatory)
* 13-17 years old
* Physical training level expected to remain relatively constant over the study period
* Ability to follow directions, including swallowing multiple pills daily and complying with reproductive risk recommendations (post-menarchal females)
* Within reasonable driving distance to the University of Minnesota - Twin Cities
* Reads English

Exclusion Criteria:

* Pregnant, lactating, or trying to become pregnant
* Surgery in the past 9 months
* Botulinum toxin injections in past 3 months
* Selective dorsal rhizotomy in the past 12 months
* Upcoming invasive treatment within the study period that may affect strength or functional mobility (e.g., surgery, botulinum toxin injections, intrathecal baclofen pump or dosage change)
* Liver disease or liver disorder
* Kidney disease or disorder
* Prescription drug or nutrition supplement contraindications
* Excessive research or medical-related radiation exposure in the past 12 months (approximately 500 mrem or greater)
Feasibility of a Cytokine Expression Profile in Immune Cells as an Orientation Tool in Therapeutic Decisions for Auto-inflammatory and Auto-immune Diseases

This study will assess the feasibility of using cytokine expression profiles in blood samples as a method for evaluating rheumatoid polyarthritis


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* Patient is at least 18 years old
* Subjects included as patients have rheumatoid polyarthritis according to ACR EULA 2010, DAS28\>3.2 criteria
* Subjects included as controls are healthy volunteers who have no overexpression of cytokines

Exclusion Criteria:

* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient has had at least 3 months of specific treatment that can potentially impact cytokine profile
Fertility Surgery, Prospective Analysis

From September 2006 a prospective cohort study is conducted among all patients operated at the Leuven University Fertility Centre to evaluate clinical and economical outcome after CO2 laser laparoscopic fertility surgery.

The main outcome measurements are postoperative complications, pain, quality of life, sexual satisfaction, economic life circumstances, cumulative pregnancy rate and cumulative recurrence rate of endometriosis.

Eligibility Criteria:
Inclusion Criteria:

* All patients
* operated at the Leuven University Fertility Centre of the Department of Obstetrics and Gynaecology of the University Hospitals Leuven, Leuven,Belgium,
* from September 2006 to August 2008.

Exclusion Criteria:

* patients of other than the Dutch language
RSA-Study of Cemented Hip Prostheses With Five Different Articulations

The purpose of this study is to compare wear and migration of the following hip prostheses:

1. Charnley monoblock 22.2mm caput and OGEE polyethylene acetabular component
2. Spectron EF stem with Reflection polyethylene cup and 28 mm CoCr caput
3. Spectron EF stem with XLPE cup and 28 mm CoCr caput
4. Spectron EF stem with Reflection polyethylene cup and 28 mm Oxinium caput
5. Spectron EF stem with XLPE cup and 28 mm Oxinium caput

Detailed description in:

Wear and migration of highly cross-linked and conventional cemented polyethylene cups with cobalt chrome or Oxinium femoral heads: a randomized radiostereometric study of 150 patients.

Kadar T, Hallan G, Aamodt A, Indrekvam K, Badawy M, Skredderstuen A, Havelin LI, Stokke T, Haugan K, Espehaug B, Furnes O.

J Orthop Res. 2011 Aug;29(8):1222-9. doi: 10.1002/jor.21389

Eligibility Criteria:
Inclusion Criteria:

* arthritis
* dysplasia

Exclusion Criteria:

* obesitas
* charcots
* paget
* malignancy
Scapular Positioning in Standing Position Using Sonography

The objective of this study is to analyse the positioning of the scapula in standing position and compared to the supine position (CT scan) in 3 dimensions (3 rotations of the scapula) using a non-radiant, portable system, combining an ultrasound probe with marker and a camera integrated into a Tablet for the three-dimensional location of the marker (probe).

This is a mono-center trial. Patients in the process of pre-operative care of a reverse shoulder arthroplasty (CT Scan already available as part of the care course in supine position) will be offered the study. A localizer ultrasound will be performed during surgical consultation or the day before the surgery in standing position (duration: 1/2 day). This consultation takes place during the course of the surgical consultation or when the patient is admitted the day before his surgical procedure.

Eligibility Criteria:
Inclusion Criteria:

* Major patients and agreeing to participate in the study after oral and written information.
* Care course patients for a reverse shoulder arthroplasty on a native shoulder joint

Exclusion Criteria:

* Patients under the age of 18
* Patients refusing to participate in the study
* Patients whose condition does not allow informed consent
* Patients who are subject to legal protection (safeguarding of Justice, curatorship, guardianship), persons deprived of their liberty
* Unaffiliated patients and non-beneficiaries of a health insurance plan
Evaluation of Resin Composite Posterior Restorations Using Modeling Resin Insertion Technique in Class I Lesions

Evaluation of Resin Composite Posterior Restorations Using Modeling Resin Insertion Technique versus Conventional Composite Placement Technique in Class I Lesions: Randomized Clinical Trial

Statement of the problem In a restorative procedure, an important objective is to obtain restorations with smooth surfaces. Surface roughness has a major influence on plaque accumulation, secondary caries, and gingival irritation. Further, it may directly influence wear behavior and the marginal integrity of composite restorations. A roughened surface of a resin composite restoration is also likely to be stained by exogenous sources, such as coffee, tea, or red wine, leading to the discoloration of the material.

One of the main drawbacks of sculpting composite restorations is that some materials are sticky, reducing the ease of handling and insertion of the material into the tooth cavity. Some materials readily adhere to the composite instruments; thus, limiting reestablishment of the shape and anatomical contour of the tooth. As a result, the application of lubricants on the composite instrument such as modeling liquids/resins between the layers of composite have been proposed.

Rationale Modeling resins can be directly applied between the layers using a brush or can be used as a lubricant on manual instruments. In both the aforementioned techniques, the ease of instrumentation during the placement of esthetic restorations is superior, compared to the traditional restorative techniques. Moreover, any pores or gaps on the surface of the composite placed by means of the layering technique can be easily resolved. Hence, the modeling resin facilitates the reduction of defects in the body of the restoration and aids in improving the mechanical properties.

Although these methods are widely used, a potential shortcoming is that these techniques may adversely affect the physical and surface properties of the resin composite. However, it is unknown whether different compositions of adhesives or modeling agents may affect the surface microhardness, surface roughness, and color stability of composites over time.

Eligibility Criteria:
Inclusion Criteria:

Participants:

1. Adult Patients (25-45).
2. Good oral hygiene (plaque index score 0 or 1).
3. Absence of damaging habits (e.g. bruxism, nail biting, tooth clenching and mouth breathing).

Teeth:

1. Vital teeth with a normal appearance and morphology.
2. Primary carious lesions in molar teeth.

Exclusion Criteria:

Participants:

1. Patients with bad oral hygiene.
2. Patients with known allergic or adverse reaction to the tested materials.
3. Any uncontrolled systemic disease, pregnant or lactating women and any patient incapable to be present at recall follow up visits.

Teeth:

1. Non-vital, fractured, or cracked teeth.
2. Teeth with secondary caries or in need of replacement of existing restorations.
3. Defective restorations adjacent to or opposite the tooth restored in the study.
4. Rampant caries, atypical extrinsic staining of teeth.
A Longitudinal Study to Explore the Impact of Gut Microbiome on Brain Health in Alzheimer's Disease

Gut microbiota dysfunction is associated with Alzheimer's disease (AD). However, the potential modulatory mechanism remains unclear. Previous studies have shown that gut-derived metabolites short-chain fatty acids (SCFAs) may be the key mediators between gut microbiota and brain, participating in the modulatory pathway "gut microbiota-SCFAs-brain networks". In this project, high-throughput targeted metabolomics technique will be used to explore the differences of SCFAs in the spectrum of AD, including cognitively normal individuals, subjective cognitive decline (SCD), mild cognitive impairment (MCI), and AD dementia. Then, the gut microbiome and multi-modal MRI techniques will be combined to elucidate potential interaction mechanisms of "gut microbiota-SCFAs-brain networks". Finally, based on multi-omics features extracted from gut microbiome, metabolomics, and neuroimaging after five years, the diagnostic model of SCD due to preclinical AD will be established using machine learning methods.


Eligibility Criteria:
Inclusion Criteria:

* Cognitively normal group:

  1. normal performance on standardized cognitive tests;
  2. with no cognitive complaints or any concerns (worries).
* SCD group:

  1. self-experienced persistent decline in memory, rather than other domains of cognition;
  2. normal performance on standardized cognitive tests;
  3. failure to meet the criteria for MCI or dementia;
  4. age at onset of SCD ≥ 60 years old;
  5. onset of SCD within the last 5 years;
  6. concerns (worries) associated with SCD;
  7. feeling of worse performance than others of the same age group.
* MCI group:

  1. having impaired scores on both measures in at least one cognitive domain (memory, language, or speed/executive function);
  2. having impaired scores in each of the three cognitive domains (memory, language, or speed/executive function);
  3. the Functional Activities Questionnaire (FAQ)≥9.
* AD dementia group:

  1. meet the criteria for dementia and have impaired daily functional activities;
  2. episodic memory deficit; 3) Clinical Dementia Rating (CDR) ≥ 1.

Exclusion Criteria:

* a history of stroke;
* major depression and anxiety;
* other central nervous system disorders that may cause cognitive impairment, such as Parkinson's disease, tumors, encephalitis, and epilepsy;
* cognitive impairment caused by traumatic brain injury;
* systemic diseases, such as thyroid dysfunction, syphilis and HIV;
* psychosis or congenital mental developmental delay;
* a history of using antibiotics, probiotics, prebiotics, or synbiotics within 3 months;
* the use of corticosteroid, immune stimulating medications, and immunosuppressive agents;
* major gastrointestinal tract surgery in past 5 years;
* severe gastrointestinal diseases, such as irritable bowel syndrome, infammatory bowel disease, severe gastritis, other dysfunction in digestion and absorption, which has been reported to infuence gut microbiota
Dexmedetomidine an Effective Drug in Reducing Anesthetic Requirements in External Dacrocystorhinostomy (DCR) Patients

Assessing the intra and postoperative hemodynamic stability in patients undergoing external dacrocystorhinostomy under general anesthesia using Dexmedetomidine as a preoperative sedation compared to traditional technique with intraoperative analgesia and assessing decreased anesthetic requirements intra and postoperative

Dexmedetomidine is a highly selective alpha 2 adrenoceptor agonist, having characteristics of natural sleep like sedation, can reduce pain intensity and opioid consumption without influencing the time of recovery from general anesthesia

Eligibility Criteria:
Inclusion Criteria:

patients of both sexes 16 years to 75 years of age ASA (American society of Anesthesiologists) I-III

Exclusion Criteria:

* Pediatric age group
* ASA more than III
Optical Coherence Tomography (OCT) Trial in Multiple Sclerosis

This is a 3-year, pharmacologically non-interventional study to evaluate OCT as an outcome measure in patients with relapsing remitting multiple sclerosis (RRMS).

Approximately 350 RRMS patients, either untreated or treated with an approved MS disease-modifying therapy and approximately 70 reference subjects without ophthalmologic or neurologic disease are enrolled. No study medications are provided. Patients on disease-modifying therapy are treated according to the local prescribing information. For each MS patient and each reference subject, the study consists of Screening (up to 1 month), Baseline, and a 36-month longitudinal data collection phase. Eligibility will be confirmed during Screening.


Eligibility Criteria:
Multiple sclerosis patients

* A diagnosis of MS as defined by the 2005 revision to the McDonald criteria with a relapsing-remitting course
* MS disease duration of more than one year (from diagnosis of MS) before study entry

Healthy volunteers

- Matched to MS patients based on age, gender, ethnicity and visual refraction
Bad News- Diagnosis: Epilepsy in Childhood

"Bad news" are defined as"any information which adversely and seriously affects an individuals' view of future. Families of chronic ill children are exposed to a high stress load. This project is to investigate the stress burden directly after diagnosis of epilepsy in childhood and coping capabilities in the course of time and how quality of communication at the time of diagnosis effects stress perception and coping behaviour in the following 12 months.

Perceived/ experienced advisory skills of the physician will be assessed by parents and children (older than eleven) on the basis of SPIKES - a Six-Step Protocol for Delivering Bad News.

The subjective perception regarding quality of dialogue in relationship to childrens and their parents quality of life and their coping strategies will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed epilepsy (according to International League Against Epilepsy (ILAE) criteria):
* at least two unprovoked epileptic fits at intervals of at least 24 hours or
* one unprovoked epileptic fit and a recurrence risk of at least 60% or
* epilepsy syndrome

Exclusion Criteria:

* children with intensive care treatment as inpatients
* parents with insufficient German language capabilities
* parents and children with exposure to traumatic events in the past three months that could probably lead to post traumatic distress (loss of a loved person, severe traffic accident, raid, violence, sexual assault, war)
A Study of Galcanezumab (LY2951742) in Participants With Episodic Migraine

The reason for this study is to see if the drug galcanezumab is safe and effective in participants with episodic migraine. The study will last about 53 weeks and may include up to 12 visits.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 (1.1 or 1.2) (ICHD-3 2018) with a history of migraine of at least 1 year prior to screening and migraine onset prior to age 50
* Prior to screening, participants must have a history of 4-14 migraine headache days and at least 2 migraine attacks per month on average within the past 3 months

Exclusion Criteria:

* Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
* Current use or prior exposure to galcanezumab or another calcitonin gene-related peptide (CGRP) antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody
* Participants who are taking, or are expected to take, therapeutic antibodies during the course of the study (for example, adalimumab, infliximab, trastuzumab, bevacizumab, etc.)
* Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab
* Women who are pregnant or nursing
* History of chronic migraine, daily persistent headache, cluster headache, medication overuse headache, migraine with brainstem aura, or hemiplegic migraine