louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02761005: Eradication of H. Pylori Therapy Individualized by the Mutation of 23S rRNA of H. Pylori
Official title: Eradication of H. Pylori With the Regimen Individualized Susceptibility of H. Pylori to Clarithromycin Determined by the Mutation of 23S rRNA of H. Pylori
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: H. Pylori Infection
Keywords: Eradication therapy
Mutation of 23S rRNA of H. pylori
Personalized therapy
Lead sponsor: Hamamatsu University
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients infected with H. pylori are treated with the individualized regimen which is based on the mutation of 23S rRNA of H. pylori.

Detailed description: Patients infected with H. pylori undergo the gastroscopy. During the gastroscopy, gastric mucus samples are collected, from which DNA is extracted. The DNA samples are subjected the full-auto SNP analyzer and the from A to G mutation of 23s rRNA of H. pylori at the positions of 2142 and 2143 is measured. When the mutation is detected, patients are diagnosed to be infected with clarithromycin-resistant strains of H. pylori and therefore, treated with the triple therapy with vonoprazan 20 mg bid + amoxicillin 750 mg bid + metronidazole 250 mg bid for 1 week. When the mutation is not detected, patients are considered to be infected with clarithromycin-sensitive strains of H. pylori and therefore, treated with the triple therapy with vonoprazan 20 mg bid + amoxicillin 750 mg bid + clarithromycin 200 mg bid for 1 week. The success or failure of eradication was determined based on the 13C-urea breath test performed 1 month after the therapy. The total eradication rates with this strategy was compared with that by the standard regimen in Japan performed in the same period of the study.

Eligibility criteria: Inclusion Criteria:

* Patients infected with H. pylori are invited to the study.
* Patients not allergic to the any of the drugs used for eradication of H. pylori.
* Patients who has agreed to participate to the study.

Exclusion Criteria:

* Patients allergic to the any of the drugs used for eradication of H. pylori.
* Patients who do not agree to the study.

Primary outcomes:
measure: Eradication rates
timeFrame: Eradication of H. pylori is measured 1 month after the therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine
state: Shizuoka
Study officials:
affiliation: Hamamatsu University
name: Takahisa Furuta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03593005: Acute Exposure to High Altitude on Symptoms
Official title: Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: High Altitude
Altitude related symptoms
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Including a baseline assessment and assessments at Low altitude and High altitude
Primary purpose: PREVENTION

Brief summary: Randomized crossover Trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to High Altitude (2500m above sea level) in altitude related symptoms

Detailed description: Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, 6MWT, pulmonary function test, clinical assessment and blood gas Analysis.

Randomly assigned to the order of testing, the participants will be tested at Low Altitude (Zurich, 470m) and High Altitude (2500m).

Regularly during the exposure of approximately 5 hours, the participants will be asked to complete altitude related symptom questionnaires

Eligibility criteria: Inclusion Criteria:

* Informed consent
* PH diagnosed according to internation Guidelines: mPAP ≥ 25 mmHg along with a PAWP ≤15 mmHg during right heart catheterization at the time of Initial diagnosis
* PH class 1 (PAH) or 4 (CTEPH)
* Stable condition, on the same medication for \> 4 weeks
* Patient live permanently at an altitude \< 1000m asl.

Exclusion Criteria:

* Resting PaO2 ≤7.3 kPA corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed)
* Severe daytime hypercapnia (pCO2 \> 6.5 kPa)
* Susceptibility to high altitude related diseases (AMS, HAPE, etc.) based on previous experienced discomfort at altitudes.
* Exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation
* Residence \> 1000m above sea level
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with Walking disability
* Women who are pregnant or breast feeding

Primary outcomes:
measure: Altitude related symptoms at High Altitude
timeFrame: 5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Respiratory Clinic, University Hospital of Zurich
Study officials:
affiliation: University of Zurich
name: Silvia Ulrich, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03102905: Prevalence of Replication of Human Herpes Virus 6 (HHV6) in Blood and Skin During Exanthemia, in Patients With Hemopathy. Is There a Correlation With the Etiology of the Exanthema?
Official title: Prevalence of Replication of Human Herpes Virus 6 (HHV6) in Blood and Skin During Exanthemia, in Patients With Hemopathy. Is There a Correlation With the Etiology of the Exanthema?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HHV6
Exanthema
Hemopathy
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient hospitalized in the Clinical Hematology and Cellular Therapy department of the CHU Amiens-Picardie between 01/01/2011 and 31/01/2016

Brief summary: To look for the replication of HHV6 by PCR in the skin, in these patients with haemopathies presenting an exanthema. This will make it possible to evaluate the prevalence of the positivity of this PCR in the skin. Then the investigator can investigate whether there is an association between the positivity of HHV6 PCR in the blood and / or skin and the viral etiology of the exanthema. If this association exists, it will make it possible to improve the diagnosis in the context of the exanthema and thus to improve the therapeutic management of these patients.


Eligibility criteria: Inclusion Criteria:

* Supported for any type of hemopathy.
* Allograft, autografted or ungrafted haematopoietic stem cells
* Having presented an exanthema during hospitalization, for which a cutaneous biopsy had been performed
* Having had a blood test of the HHV6 virus by PCR at least within the previous 40 days or following the rash.
* Age greater than or equal to 18 years
* Patient informed of the protocol by post, not having refused within one month of sending the said courier.

Exclusion Criteria:

* Patient who refused the search.
* Patient whose HHV6 PCR in the blood was carried out at a distance of more than 40 days from the skin biopsy.

Primary outcomes:
measure: Measurement of the prevalence of the positivity of cutaneous HHV6 quantitative PCR in the cohort studied.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT06527105: Impact of Sleep Quality on Outcomes After Cardiac Surgery
Official title: The Effects of Non-pharmacological Interventions on the Quality of Sleep in Cardiac Surgical Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep
Atrial Fibrillation
Delirium, Postoperative
Complications, Postoperative
Keywords: Cardiac surgery
Sleep quality
Lead sponsor: Amrita Institute of Medical Sciences & Research Center
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Sleep is a basic human need and is essential for good quality of life, good health. In fact, humans spend one third of their life time in sleeping or attempting to do so. However, sleep is not given due importance in intensive care unit (ICU)'s, although it is critical in healing process. Patient's usually get admitted to the hospital few days prior to the surgery, for complete evaluation, depending on the procedure planned. Hospital environment being, an entirely new place for inpatients, will invariably affect their sleep. Sleep deprivation is one of the major sources of anxiety and stress in all the patients during ICU stay. This means that most of patients are sleep deprived, by the time they are admitted to ICU.

The negative effects of sleep deprivation include postoperative brain dysfunction like inattention, restlessness, hallucinations, agitation, aggressiveness. The degree of cognitive impairment may range from subtle derangements in attention, reason, clarity of thought and capacity of decision making to confusion and delirium. Sleep deprivation can also induce hypertension, fatigue, metabolic disorders, cerebrovascular and cardiovascular disease


Eligibility criteria: Inclusion Criteria:

* Adult cardiac surgical patients aged above 18years undergoing elective cardiac surgery

Exclusion Criteria:

* Not willing to give consent
* Preoperative sleep medications use
* Preoperative psychological disorders, on mechanical ventilation for \>12hrs, dementia, cerebrovascular accident

Primary outcomes:
measure: Quality of sleep
timeFrame: 6 months
Secondary outcomes:
measure: Atrial fibrillation
timeFrame: 6 months
measure: Delirium
timeFrame: 6 months
measure: Intensive care unit stay
timeFrame: 6 months
measure: Vasoactive inotropic score
timeFrame: 6 months
measure: Mechanical ventilation
timeFrame: 6 months
Other outcomes:
Locations:
city: Kochi
country: India
facility: Dr. Nagarjuna
state: Kerala
Study officials:
References:
Clinical trial NCT00193297: Topotecan Plus Paclitaxel and Carboplatin in the Initial Treatment of Advanced Ovarian and Primary Peritoneal Carcinoma
Official title: A Phase II Study of a Three-Day Schedule of Topotecan Plus Paclitaxel and Carboplatin on Day Three in the Initial Treatment of Advanced Ovarian and Primary Peritoneal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovary Cancer
Keywords: Ovary Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2005-09-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the feasibility and toxicity of the combination of paclitaxel, carboplatin, and topotecan in patients with previously untreated, stage III or IV epithelial ovarian carcinoma or primary peritoneal carcinoma. We will also make a preliminary evaluation of the efficacy of this three drug regimen in the initial treatment of these patients.

Detailed description: Upon determination of eligibility, all patients will be receive:

Paclitaxel + Carboplatin + Topotecan

a maximum of six courses of chemotherapy will be given at 21 day intervals

Eligibility criteria: Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Epithelial ovarian carcinoma or primary peritoneal carcinoma
* Willing to consider second-look surgery to evaluate response if necessary
* No previous treatment with chemotherapy or radiation therapy
* Ability to perform activities of daily living with minimal assistance
* Adequate bone marrow, liver and kidney function
* Written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Age \< 18 years
* Brain metastases
* Recent history of significant heart disease within 6 months
* Other significant medical conditions

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Primary outcomes:
measure: Overall response rate
Secondary outcomes:
measure: Overall toxicity
Other outcomes:
Locations:
Study officials:
affiliation: SCRI Development Innovations, LLC
name: Anthony Greco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00749697: Radioiodine Dosimetry Protocol for Thyroid Cancer Metastases
Official title: Investigating Absorbed Radiation Dose Delivered to Differentiated Thyroid Cancer Metastases Following Administration of Fixed Activity of Radioactive Iodine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Carcinoma
Metastatic Sites Lung Bone Nodal
Keywords: radioiodine
differentiated thyroid cancers
dosimetry
metastases
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2008-09-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main purpose of the study is to establish a relationship between the administered activity of the radioiodine and absorbed dose in the tumor sites.

Detailed description: Study Design - the assessment of patients with multiple tumour sites with metastatic thyroid cancer to correlate the administered activity to absorbed dose. Patients will receive the standard therapy dose of 5.5 GBq as per the hospital policy and there will be no change for the protocol purpose.

Eligibility criteria: Inclusion Criteria:

* age above 18
* histological confirmation of the differentiated thyroid carcinoma available
* WHO performance score 0-2
* metastatic sites lung and/or bone and/or nodal (radiologically measurable disease \> 1 cm)
* life expectancy \> 6 months
* patient has undergone total/near total thyroidectomy
* no past history of sensitivity/reaction to 1311

Exclusion Criteria:

* non iodine concentrating tumours
* received chemotherapy or radiotherapy in 6 weeks
* pregnant or breast feeding patients
* iodine contrast injection in last 3 months

Primary outcomes:
measure: The primary outcome measure is to correlate the predicted dose from the tracer study with the actual absorbed dose measure on the therapeutic scan
Secondary outcomes:
measure: The secondary outcomes will be to assess the response at 6 months post therapy in each patient
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
state: Sutton
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Dr Kate Newbold
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02703597: Smoking Prevention Through Social Connections Among Adolescents - ASPIRE
Official title: Social Influence Strategies During a Web-based Smoking Prevention Intervention for Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Behavior
Keywords: Tobacco
Curiosity
Tobacco Cessation
Tobacco Prevention
Health improvement
Smoking prevention interactive experience
ASPIRE
Games for health
Surveys
Questionnaires
Interviews
Focus Group
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-03-09
Enrollment: 393
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The central hypothesis of this study is that the addition of social influence strategies to a web-based program called ASPIRE will boost its success in lowering intention to use tobacco among adolescents and experiencing stronger positive social influence. The study will involve a nested group randomized controlled trial with adolescents from after-school programs and schools (e.g., the PK Yonge school) in Florida.


Eligibility criteria: Inclusion Criteria:

* All participants must be of ages 11 through 18 (11 and 18 included; age group for adolescents adopted by several National Institutes of Health)
* Are members of after school program or school
* All participants will be English speaking
* Adolescents with developmental disability, mental or physical, are not excluded from the study. However, they will only be able to participate if (1) they understand the information presented to them in the consent document, and (2) they believe they are capable to engage in the board game, use the internet, and answer survey questions.
* Pregnant adolescents will be eligible to participate in the research study as requested by the NIH based on 2 principles that will be discussed at time of consent.

Exclusion Criteria:

-When participants don't meet the inclusion criteria

Primary outcomes:
measure: Susceptibility to Vaping
timeFrame: 4 weeks; Note that each survey completion has a window of 2 weeks, taking into account site availability, presence of students, holidays, and site resources.
measure: Susceptibility to Using Conventional Tobacco
timeFrame: 4 weeks; Note that each survey completion has a window of 2 weeks, taking into account site availability, presence of students, holidays, and site resources.
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Georges Khalil, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06395597: Variability of Healthy People and People After Stroke Results in the Nine Hole Peg Test
Official title: Variability of Healthy People and People After Stroke Results in the Nine Hole Peg Test
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Motor Activity
Keywords: Nine Hole Peg Test
stroke
Czech Extended Version of Manual for the Nine Hole Peg Test
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Czech healthy people and Czech people after stroke

Brief summary: Main aim of the study is to find out how many attempts of each subtest in the Nine Hole Peg Test should be done in clinical practice during testing people after stroke who are 20-64 years old.


Eligibility criteria: Inclusion Criteria:

* age: 20-64 years (inclusive)
* hospitalized patient in Rehabilitation Centre Kladruby
* women and men with Czech as their mother tongue
* signed Informed consent
* ability to maintain a stable sitting position for the duration necessary for testing
* comprehension of verbal instructions and recordings for the Nine Hole Peg Test

Exclusion Criteria:

* inability to successfully complete a pilot attempt of the Nine Hole Peg Test using the right and left hand
* severe spastic paresis of the upper limb, which would make the test impossible
* plegia of the upper limb
* failure to complete the test to visual or hearing impairment
* inability to understand verbal instructions
* inability to maintain attention during testing
* severe attention deficit disorder
* neglect syndrome
* fatigue
* external factors that prevent the complete completion of the test

Primary outcomes:
measure: results from the Nine Hole Peg Test
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kladruby
country: Czechia
facility: Rehabilitační ústav Kladruby
city: Praha
country: Czechia
facility: Department of Rehabilitation Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague
Study officials:
affiliation: Charles University
name: Kateřina Rybářová, Mgr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02238197: Postmarketing Surveillance Study of Atrovent® Inhalation Solution in Chronic Obstructive Pulmonary Disease
Official title: Postmarketing Surveillance Study (as Per §67 (6) AMG [German Drug Law]) of Atrovent® 500µg/2ml Inhalation Solution in Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-12
Enrollment: 477
Sex: ALL
Minimum age (years): 13
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic obstructive airways disease recruited at pneumologists and internists

Brief summary: To obtain further information on the tolerability and efficacy of Atrovent® 500µg/2ml inhalation solution in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice


Eligibility criteria: Inclusion Criteria:

* Patients of both genders, older than 40 years,who suffer from chronic obstructive Pulmonary disease
* Only patients who had not been treated with Atrovent® within the last year were to be considered for inclusion

Exclusion Criteria:

* Contraindication listed in the instructions for use/summary of product characteristics for Atrovent® 500µg/2ml Inhalation Solution
* Patients who exhibited adverse drug reactions

Primary outcomes:
measure: Change in total severity of the clinical picture rated on a 4-point scale
timeFrame: Up to 4 weeks after first study drug administration
measure: Investigator assessment of improvement of the clinical picture of the course on a 6-point symptoms profile
timeFrame: up to 4 weeks after first study drug administration
Secondary outcomes:
measure: Assessment of efficacy by investigator on a 4-point scale
timeFrame: Up to 4 weeks after first study drug administration
measure: Assessment of efficacy by patient on a 4-point scale
timeFrame: Up to 4 weeks after first study drug administration
measure: Assessment of tolerability by investigator on a 4-point scale
timeFrame: Up to 4 weeks after first study drug administration
measure: Assessment of tolerability by patient on a 4-point scale
timeFrame: Up to 4 weeks after first study drug administration
measure: Number of patients with adverse drug reactions
timeFrame: Up to 4 weeks after first study drug administration
Other outcomes:
Locations:
Study officials:
References: