louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02242175: Efficacy of Hydrogen Breath Test in the Patients With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 147
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Irritable bowel syndrome is characterized by abdominal discomfort and bowel habit change. It is increasing worldwide. But the pathophysiology of the irritable bowel syndrome is not proven. So, the treatment's target is the relief of the symptoms.

Small intestinal bacterial overgrowth considered as the cause of the irritable bowel syndrome. Because, it is related to the postprandial abdominal discomfort and the abdominal discomfort could be relieved after taking antibiotics. There are several diagnostic methods for small intestinal bacterial overgrowth. hydrogen breath test is non-invasive method for diagnosis of the small intestinal bacterial overgrowth. But, there is no standardized cut-off value for the hydrogen breath test. So, we want to compare the hydrogen breath test between the irritable bowel syndrome patients and normal people. And then, we want to analyze the efficacy of hydrogen breath test for the diagnosis of irritable bowel syndrome.


Eligibility criteria: Inclusion Criteria:

1. over 19 years old, male and female
2. normal people (control group, who has no abdominal symptoms - diarrhea, constipation etc.)
3. irritable bowel syndrome patients (irritable bowel syndrome means that within the last 3 months abdominal discomfort more than three days for a month and satisfies over the below two items) 1) symptom relived after defecation 2) bowel habit change, the times of defecation changed 3) the change of the morphology of the stool

Exclusion Criteria:

1. patients who do not agree for participation
2. patients who have history for treatment of irritable bowel syndrome
3. patients who is uncontrolled diabetes mellitus
4. patients who have small bowel or large bowel diseases
5. patients who had surgery for abdomen
6. patients who are taking antibiotics, anti-depressants within 1 week
7. patients who are taking proton pump inhibitors or opioids for analgesics
8. patients who have history of bowel adhesion

Primary outcomes:
measure: The difference of H2 elevation level through the hydrogen breath test between the irritable bowel syndrome patients and the normal people
timeFrame: Within the 24 hours after 8-12 hours fasting
Secondary outcomes:
measure: The difference of methane level through the hydrogen breath test between the irritable bowel syndrome patients and the normal people
timeFrame: Within the 24 hours after 8-12 hours fasting
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sevrance hospital
Study officials:
References:
Clinical trial NCT05106075: Pilot Study to Validate ex Vivo Expression of Specific Biomarkers of Human Resolutive Macrophages
Official title: Pilot Study to Validate ex Vivo Expression of Specific Biomarkers of Human Resolutive Macrophages
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammation
Keywords: macrophage
inflammation
inflammation resolution
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Human resolutive macrophages are essential immune cells in the resolution of inflammation. This particular type of macrophages remains poorly known and currently there are no biomarkers to identify them in vivo. Within UMR1098-RIGHT, specific biomarkers (secreted molecules and membrane receptors) of human resolutive macrophages (healthy volunteers) have been identified in vitro, but their existence in vivo remains an outstanding issue. An exploratory study (lack of data from the literature) will validate the ex vivo expression of these markers in samples of patients whose inflammation is not, or little, supported by the available therapies (NSAIDs, biotherapies, corticosteroids).


Eligibility criteria: Inclusion Criteria:

* Age Limits (18-80 years)
* Information and non-opposition for participating in the study
* Patients suffering from periodontitis grade III ou IV
* Patients suffering from microcristalline arthritis
* patient with health insurance

Exclusion Criteria:

* patient under corticotherapy
* pregnancy
* non-compliant patient
* patient with no health insurance
* patient in exclusion period from an other study
* legal incapacity

Primary outcomes:
measure: Quantification of cytokine concentrations in samples by ELISA
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHRU Besançon
city: Montbéliard
country: France
facility: Dentist'S Office
Study officials:
References:
Clinical trial NCT01749475: Hypnosis vs Midazolam for Sedation for TEE
Official title: Hypnosis for Sedation in Transesophageal Echocardiography: Comparison With Midazolam
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clinical Indications for Transesophageal Echocardiography
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2012-12-13
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitting to cardiology department for transesophageal echocardiography (TEE)

Brief summary: Most of the reports on hypnosis in the literature have focused on pain control during minor operations. With this study we aimed to evaluate the role of hypnosis on sedation for transesophageal echocardiography and compare it with commonly used sedative midazolam.


Eligibility criteria: Inclusion Criteria:

* indications for TEE
* American Society of Anesthesiology (ASA) physical status I-III

Exclusion Criteria:

* mental illness,
* psychotropic medication use,
* hypersensitivity to drugs
* a body mass index over 30.

Primary outcomes:
measure: Sedative effects of hypnotherapy and the drug "midazolam" indicated by anxiety scores and bispectral index (BIS) monitoring
timeFrame: during transesophageal echocardiography
Secondary outcomes:
measure: measurement of alertness after sedation with continuous performance test (CPT)
timeFrame: the same time frame
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Dr Sadi Konuk Training Hospital
Study officials:
References:
Clinical trial NCT00515775: Influence of a Inhaled Corticosteroid Therapy Versus Corticosteroid + LABA Therapy on the FeNO of Asthmatic Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Asthma
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2007-08-14
Enrollment: 27
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Allergic asthmatics

Brief summary: The purpose of the study is to investigate, whether the FeNO concentration of asthmatic children is influenced differently by inhaled corticosteroid compared to inhaled corticosteroid + long acting beta agonist. The study hypothesis is that the FeNO concentration is more decreased in patients with a combination therapy compared to those with a corticosteroid mono therapy.


Eligibility criteria: Inclusion Criteria:

* allergic asthma since \> 6 months equal or lower corticosteroid therapy before study entry FEV1\>50%

Exclusion Criteria:

* severe asthma respiratory infection within the last 4 weeks smoking

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Children´s Hospital, Technical University of Dresden
Study officials:
affiliation: University Children´s Hospital, Technical University of Dresden
name: Christian Vogelberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03161275: Measurement of the Cerebral Saturation for Assessment of Safety of Epidural Anaesthesia During Abdominal Surgery
Official title: Measurement of the Cerebral Saturation for Assessment of Safety of Epidural Anaesthesia During Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Complications From General Anesthesia
Cerebral Ischemia
Anesthesia; Reaction
Keywords: cerebral saturation
epidural anaesthesia
Near Infrared Spectroscopy (NIRS)
Regional cerebral oxygen saturation
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One hundred and one (101) subsequent and non-randomised patients, age between 35 and 84 years (mean 64±10) hospitalised at the 1st Department of General, Oncologic and Gastroenterologic Surgery of the UJ CM in Krakow, qualified for abdominal surgeries were enrolled.

Brief summary: Subsequent and non-randomised patients, adult patients qualified for major abdominal surgeries were enrolled


Eligibility criteria: Inclusion Criteria:

* scheduled for major abdominal surgery for at least 2 h
* under general anesthesia
* American Society of Anesthesiologists（ASA）physical status : II \~ III
* Age \> 18

Exclusion Criteria:

* refuse of patients
* patient with results of test: "The Mini Mental State Examination"" less then 24 before operation
* neurosurgery history of patients

Primary outcomes:
measure: cerebral saturation
timeFrame: every 5 minutes throughout the surgery
Secondary outcomes:
measure: the Mini Mental State Examination test
timeFrame: Baseline, 4 day after surgery
Other outcomes:
Locations:
city: Cracow
country: Poland
facility: University Hopital
state: Małpololskie
Study officials:
affiliation: University Hospital in Cracow
name: Tomasz Składzień, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT01187875: Resistant Starch and Satiety
Official title: Satiety Response of Resistant Starches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy Adults
Keywords: satiety, dietary fiber
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2010-08-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Dietary fiber consumption may contribute to weight regulation by improving satiety. In an earlier study the investigators found that a muffin containing resistant starch was more effective than other fibers in altering satiety. The objective of this study is to determine if 2 resistant starches consumed in muffins alter satiety and whether a mixture of resistant starches is more effective than either alone in enhancing satiety.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* Age 18-64 years
* Non-smoking
* Not taking medication
* Non dieting (weight stable in prior 3 months)
* BMI 18-27
* English literacy

Exclusion Criteria:

* Do not regularly consume breakfast
* Food allergies to ingredients found in the study products
* BMI \<18 or \>27
* Diagnosed cardiovascular disease, renal disease, hepatic disease, or diabetes mellitus
* Cancer in previous 5 years
* Any gastrointestinal disease or condition
* Recent bacterial infection (\< 3months)
* Recent or concurrent participation in an intervention research study
* History of drug or alcohol abuse in prior 6 months
* Use of lipid lowering, anti-hypertensive, or anti-inflammatory steroid medication
* Eating disorder
* Vegetarians
* People who eat more than approximately 15 grams of fiber per day
* Women who are pregnant or lactating
* Women with irregular menstrual cycles

Primary outcomes:
measure: Satiety response using visual analogue scales
timeFrame: 0 minutes postprandially
measure: Satiety response using VAS
timeFrame: 15 minutes postprandially
measure: Satiety response using VAS
timeFrame: 30 minutes postprandially
measure: Satiety response using VAS
timeFrame: 45 minutes postprandially
measure: Satiety response using VAS
timeFrame: 60 minutes postprandially
measure: Satiety response using VAS
timeFrame: 90 minutes postprandially
measure: Satiety response using VAS
timeFrame: 120 minutes postprandially
measure: Satiety response using VAS
timeFrame: 180 minutes postprandially
measure: Satiety response using VAS
timeFrame: 240 minutes postprandially
Secondary outcomes:
measure: Ad libitum food intake
timeFrame: 240 minutes postprandially and over 24 hours
measure: Breath hydrogen response
timeFrame: 0, 240 minutes
measure: Gastrointestinal tolerance using visual analogue scales (VAS)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Joanne L Slavin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01590875: Validation Durability Adenosine Effect in Verification Pulmonary Vein Isolation
Official title: Validation of the Durability of the Adenosine Effect in Verification of Pulmonary Vein Isolation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
ablation
pulmonary veins
adenosine
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2012-05-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Adenosine is used clinically to assess permanency of electrical isolation of pulmonary veins during atrial fibrillation ablation, however, the methodology has not been validated either in terms of the reproducibility of the adenosine response or the effect on clinical outcomes, namely whether using pulmonary vein reconnection to guide additional ablation lowers rate recurrent atrial fibrillation post ablation. Study will test the hypothesis that the response to adenosine used in this manner is reproducible over time.

Detailed description: Patients undergoing pulmonary vein isolation as part of atrial fibrillation ablation will be randomized to treatment and control groups. Treatment group subjects will received 12 mg IV adenosine to evaluate pulmonary vein reconnection after initial electrical isolation is documented. If electrical reconnection is not observed at 5 minutes, a second dose of adenosine will be administered, monitoring again for electrical reconnection. Control patients will be observed for 10 minutes post initial electrical isolation of the pulmonary vein for spontaneous electrical reconnection. If reconnection is observed, veins will be re-isolated per standard clinical practice. This procedure will be repeated for each of a patient's pulmonary veins. Patients will be followed up at clinical visits to examine for adverse effects of procedure and/or adenosine administration as well as atrial fibrillation recurrence.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing atrial fibrillation ablation, pulmonary vein isolation by catheter for standard clinical indications

Exclusion Criteria:

* allergy or contraindication to adenosine,
* inability to give informed consent,
* currently taking dipyridamole,
* verapamil or theophylline and
* breast-feeding mothers.

Primary outcomes:
measure: Pulmonary Vein Reconnection
timeFrame: 5 minutes post infusion first dose adenosine
measure: Pulmonary Vein Reconnection
timeFrame: Pulmonary vein reconnection will be monitored for 5 minutes post second dose of adenosine, or on average for 15 minutes after initial electrical isolation of the pulmonary vein.
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Marcie G Berger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04145375: Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol
Official title: Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
PHASE2
Conditions: mCRPC
Keywords: Zenith
prostate cancer
Lead sponsor: Zenith Epigenetics
Sponsor class: INDUSTRY
First posted: 2019-10-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol

Detailed description: This is an open label, non-randomized, single-arm continuation protocol study using ZEN003694. Patients who have completed participation in their original ("parent") ZEN003694 protocol and have clinical benefit as determined by the investigator may continue to receive treatment with ZEN003694 in the continuation protocol. The patient must have been enrolled in a Zenith Epigenetics sponsored ZEN003694 therapeutic study to be eligible for participation in this continuation protocol.

Eligibility criteria: Inclusion Criteria:

1. Protocol-defined completion in a parent ZEN003694 trial
2. Patient has clinical benefit as determined by the investigator at the time of entry to the continuation protocol
3. ECOG performance status of 0 or 1
4. Acceptable ZEN003694 tolerability, in the judgment of the investigator
5. Initiation of dosing in this continuation trial to occur within two weeks (14 days) of completing dosing in the parent trial, unless more time is approved by the sponsor in writing

Exclusion Criteria:

1. Concurrent participation in another clinical investigational treatment trial
2. Require addition of or change to a new concomitant therapy to adequately treat the malignancy under study
3. Discontinued ZEN003694 or withdrew consent to participate in original Zenith Epigenetics-sponsored ZEN003694 study
4. Any other reason that in the opinion of the Investigator would prevent the patient from completing participation or following the study schedule

Primary outcomes:
measure: Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Evaluate radiographic response rate by RECIST 1.1 criteria
timeFrame: Up to 3 years
measure: Evaluate Overall survival (OS): Time from date of first dose of ZEN003694 in the parent protocol or randomization to the date of death from any cause
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco Medical Center
state: California
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References:
Clinical trial NCT01667575: Efficiency Study of Clarithromycin and Bismuth-containing Quadruple Therapy to Treat H.Pylori
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Functional Dyspepsia
Peptic Ulcer
Helicobacter Pylori
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2012-08-17
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to observe the efficacy of ten day triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment.

Detailed description: The success rate of currently recommended triple therapy with a proton pump inhibitor (PPI) plus amoxicillin and clarithromycin has fallen into the unacceptable range. The purpose of this study is to observe the efficacy of ten day triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment, while ten day triple therapy is used as control.

Eligibility criteria: Inclusion Criteria:

* patients who presented with upper gastrointestinal symptoms and endoscopically proven H.pylori-positive functional dyspepsia and scarred peptic ulcers

Exclusion Criteria:

* patients less than 18 years old, with history of H. pylori infection treatment, with previous gastric surgery, pregnancy, lactation, major systemic diseases, administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks, or allergy to any one of the given medication in the regimens.

Primary outcomes:
measure: Eradication rate of Helicobacter pylori
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Hong Lu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01401075: RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients
Official title: Prospective Controlled Randomized Comparative Study About Quality of Life (QoL), Immunomodulation and Safety of Adjuvant Mistletoe Treatment in Patients With Gastric Carcinoma Receiving Chemotherapy After Operation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastric Cancer
Keywords: Quality of Life
QoL
EORTC QLQ-C30
EORTC QLQ-STO22
5-FU
Viscum album
Lead sponsor: Abnoba Gmbh
Sponsor class: INDUSTRY
First posted: 2011-07-25
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evaluation of safety and efficacy of a standardized mistletoe extract (abnobaVISCUM® Quercus, aVQ) in patients with gastric cancer receiving oral chemotherapy.


Eligibility criteria: Inclusion Criteria:

* postoperative UICC stage Ib/II gastric carcinoma
* indication for oral chemotherapy with doxifluridine
* ECOG performance status 0 or 1
* normal liver and kidney function

Exclusion Criteria:

* inability to answer the QoL scales
* concomitant therapy with steroids or biological response modifiers
* individual hypersensitivity to mistletoe preparations
* pregnancy or lactating
* participation in another clinical trial

Primary outcomes:
measure: Quality of Life
timeFrame: 24 weeks
Secondary outcomes:
measure: Immunomodulation
timeFrame: 24 weeks
measure: Safety and tolerability
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: ASAN Medical Center
Study officials:
affiliation: ASAN Medical Center, Seoul
name: Byung-Sik Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim KC, Yook JH, Eisenbraun J, Kim BS, Huber R. Quality of life, immunomodulation and safety of adjuvant mistletoe treatment in patients with gastric carcinoma - a randomized, controlled pilot study. BMC Complement Altern Med. 2012 Oct 3;12:172. doi: 10.1186/1472-6882-12-172.