louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02090738: A Randomized, Open-label Study on Helicobacter Pylori Eradication With Standard Triple Regimen Plus Acetazolamide
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: H. Pylori Infection
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 0
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: TREATMENT

Brief summary: Helicobacter pylori infection is associated with several gastric diseases, including gastritis, peptic and duodenal ulcers, gastric carcinoma and MALToma. In 1994, the WHO classified the organism as a type 1 carcinogen. In order to eradicate H. pylori, at least two antibiotics and a proton pump inhibitor are used as a standard therapy regimen. Emerging antibiotic resistance to metronidazole or clarithromycin, however, has made successful treatment of infection progressively more difficult, with the success rate of standard triple therapy now at 70%, well below the 80% required for treatment of infectious diseases. Therefore, new treatment regimen is required for successful H. pylori eradication.

On the other hands, many in vitro studies revealed that bacterial carbonic anhydrase in H. pylori has an important role for surviving of H. pylori in the stomach. It was demonstrated that mutation of carbonic anhydrase affected survival of H. pylori. The investigators therefore expected that administration of carbonic anhydrase inhibitor (acetazolamide) with standard H. pylori eradication regimen would increase the eradication rate. Here, the investigators aim to evaluate the efficacy of standard triple regimen plus acetazolamide for H. pylori eradication.


Eligibility criteria: Inclusion Criteria:

1. Age, between 19 and 70
2. H. pylori infected patients

Exclusion Criteria:

1. Previous history of H. pylori eradication
2. Previous history of gastrectomy
3. Administration of PPI, H2 blocker, antibiotics, or bismuth within 1 month prior to enrollment
4. Allergy to sulfonamide
5. Electrolyte imbalance
6. Adrenal insufficiency
7. Pregnancy or breast milk feeding
8. Active infection
9. Severe hepatic dysfunction
10. Severe renal dysfunction
11. Severe bone marrow dysfunction
12. Significant neurologic or psychologic disease

Primary outcomes:
measure: H. pylori eradication rate
timeFrame: 1 month from the eradication therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: severnace Hospital
state: Seodaemun-gu
Study officials:
References:
Clinical trial NCT00716638: Trauma-focused CBT Versus EMDR in the Treatment of Posttraumatic Stress Disorder
Official title: Trauma-focused CBT vs. EMDR in the Treatment of Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
First posted: 2008-07-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effectiveness of trauma-focused cognitive behaviour therapy (TF-CBT) versus eye movement desensitization and reprocessing (EMDR) in the treatment of trauma survivors with post-traumatic stress disorder (PTSD). Patients will be randomly assigned to TF-CBT or EMDR. Follow-up assessments will be conducted at 3 and 12 months post-treatment. In addition to comparing the efficacy of the two protocols, an additional focus will lie on identifying predictors for treatment outcome.


Eligibility criteria: Inclusion Criteria:

* A full diagnosis of PTSD according to the DSM-IV or subthreshold PTSD (criteria for intrusive re-experiencing are fulfilled and either three avoidance/numbing symptoms or two hyperarousal symptoms are present)
* PTSD is related to one or more single-event traumas and participants have a clear memory of this event/these events (sufficient for constructing scenes to be used in exposure)
* Age between 18 and 70
* Sufficient fluency in Dutch to complete treatment and research protocol
* If participants are using anti-depressants, they need to be on a stable dose for at least 2 weeks before the beginning of treatment and remain on this dose throughout the treatment.

Exclusion Criteria:

* Dementia or other severe cognitive impairment
* Psychosis
* Depression with suicidal ideation
* Bipolar disorder
* Borderline Personality Disorder
* Anti-social personality disorder
* Substance dependence
* Current use of tranquilizers
* Exposure to prolonged and/or chronic trauma ("type-II-trauma")

Primary outcomes:
measure: PTSD symptom severity: (a) interviewer rating (PSS-I); (b) self-report (PDS)
timeFrame: Assessed at post-treatment, 3 months and 12 months follow-up
Secondary outcomes:
measure: Depressive symptom severity (Beck Depression Inventory, BDI)
timeFrame: assessed at post-treatment, 3 months and 12 months follow-up
measure: Severity of anxiety symptoms (Beck Anxiety Inventory, BAI)
timeFrame: assessed at posttreatment, 3 months and 12 months follow-up
measure: Trauma-related appraisal (Posttraumatic Cognitions Inventory, PTCI)
timeFrame: post-treatment
Other outcomes:
Locations:
city: Zaandam
country: Netherlands
facility: PsyQ
Study officials:
affiliation: University of Amsterdam
name: Paul MG Emmelkamp, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Amsterdam
name: Thomas Ehring, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00394238: Non Alcoholic Fatty Liver Disease in Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthritis, Rheumatoid
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2006-10-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Rheumatoid arthritis is a chronic inflammatory systemic disease. It has a worldwide distribution and can affect all age group. The peak incidence is between fourth and sixth decade. It is more prevalent in women, and it's prevalence in the general population in North America is between 0.2-1.5%. The etiology of RA is unknown, although clusters of the disease in families and high concordance in mono-zydotic twins support genetic predisposition. The prevalence of fatty liver disease in patients with rheumatoid arthritis is currently unknown. We wish to study the link between the two conditions by performing a son graphic imaging of the liver in a cohort of RA patients. If indeed a high prevalence of NAFLD will be found in the RA patients, further support will be landed for the link between inflammation and fatty liver disease. These findings may also have implications regarding the management and follow up of RA patients.

The validity of sonographic imaging for detection of fatty liver diseases is currently accepted: On ultrasonographic, fatty infiltration of the liver produces a diffuse increase in echogenicity as compared with that of the kidneys. Ultrasonography has a sensitivity of 89% and a specificity of 93% in detecting steatosis and sensitivity and specificity of 77% and 89% respectively in detecting increase fibrosis.

In view of all the above data, we expected to find higher prevalence of fatty liver in the patients with higher inflammation markers compare with patients with lower markers.


Eligibility criteria: Inclusion Criteria:

* Rheumatoid arthritis

Exclusion Criteria:

* Age below 18

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Rheumatoid Clinic
Study officials:
affiliation: Shaare Zedek Medical Center Jerusalem
name: Michal Mates, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06922838: The Effectiveness of a Virtual Reality-based Multisensory Intervention
Official title: Effectiveness of a Virtual Reality-based Multisensory Intervention for Postoperative Recovery in Patients Receiving Gynecological Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gynecological Disease
Keywords: Pain management
Virtual reality
Gynecology
Postoperative recovery
Lead sponsor: Weifang Medical University
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study explores the effectiveness of a virtual reality-based multisensory intervention for postoperative recovery in patients receiving gynecological surgery.

Detailed description: This study explores the effectiveness of a virtual reality-based multisensory intervention for postoperative recovery in patients receiving gynecological surgery. The results of the study included postoperative pain response, comfort, and anxiety of the patients.

Eligibility criteria: Inclusion Criteria: 1) significant postoperative pain response (VAS score over 4); 2) age greater than 18 years and volunteered to participate in this study.

Exclusion Criteria: 1) patients with psychosomatic disorders such as delirium, schizophrenia, and bipolar disorder; 2) patients with epilepsy, motion sickness, lightsensitivity, or other neurological diseases may have difficulty wearing the VR headset; 3) patients have severe heart, liver, kidney, blood, digestive, and nervous diseases.

Primary outcomes:
measure: Pain response
timeFrame: The pain response of patients was assessed at 0.5 hour, 3 hour, 6 hour, 12 hour, 24 hour postoperatively, and immediately after intervention.
measure: Anxiety
timeFrame: The anxiety level of patients was assessed immediately after the intervention.
measure: Sleep quality
timeFrame: The sleep quality of patients was assessed at 24 hour postoperatively.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Weifang Medical University
name: Jiang Liu, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00428038: Assessment of the Pulmonary Diffusion Capacity in Healthy Infants and Infants With Chronic Lung Disease
Official title: Assessment of the Pulmonary Diffusion Capacity in Healthy Infants and Infants With Chronic Lung Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Premature
Bronchopulmonary Dysplasia
Asthma
Keywords: Infant, Premature
Bronchopulmonary Dysplasia
Asthma
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2007-01-29
Enrollment: 68
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruitment for premature infants were through Infant Lung Disease clinic at Riley Hospital for Children and IU NICU. Healthy full term infants were recruited through advertisements in local newspapers.

Brief summary: The purpose of this study is to evaluate how easily gas can be taken up by the lung. We are comparing infants born premature \<32 weeks gestation to infants born full term \>37 weeks. We hope to evaluate the differences between the two groups in order to learn more about premature lung growth and development.

Detailed description: We hypothesize that infants who were born prematurely but are clinically without chronic respiratory disease have a lower lung diffusion capacity than healthy infants born at full term, when evaluated at comparable post-conception ages. In addition, prematurely born infants that develop chronic lung disease have an even lower diffusion capacity than healthy premature infants and full term infants. A lower diffusion capacity, when normalized to lung volume, would be consistent with decreased alveolarization and alveolar surface area in the infants born prematurely. We will study the age range of 1 to 24 month as this represents the period of rapid lung growth.

Eligibility criteria: Inclusion Criteria:

* Group 1 Infants born at \< 32 weeks gestation with Chronic lung disease
* Group 2 Infants born at \<32 weeks gestation without Chronic lung disease
* Group 3 Infants born full term at \>37 weeks

Exclusion Criteria:

* Group 1 and Group 2--No heart disease, no oxygen requirement
* Group 3--No hospitalization for respiratory illness, No asthma, No heart disease, No history of wheezing, asthma or treatment with asthma medications.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
Study officials:
affiliation: Indiana University
name: Robert S Tepper, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01083238: This Study Will Investigate How Food and Age Effect the Way the Body Handles the AZD5069 Drug Given as a Oral Dose
Official title: A Phase I, Two-part Study to Investigate the Effects of Food on the PK, Safety and Tolerability of a Single Oral Dose of AZD5069 (120 mg) in Healthy Adult Volunteers (Part A) and to Compare the PK of AZD5069 in Adult and Elderly Healthy Volunteers (Part B)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: pharmacokinetics
fasting or after a high fat meal
adult
elderly adult
COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2010-03-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: AZD5069 is a new drug being tested for the possible treatment of people with chronic obstructive pulmonary disease (COPD).

This is not the first time that AZD5069 will be administered to humans in clinical trials. We are conducting this study to determine whether AZD5069 is safe and well tolerated by healthy males and females in fed and fasted states. We will compare the way the body handles this drug in the fed and fasted states, in subjects in the age group of 18 to 65 years. We will compare the way the body handles this drug between the age groups of 18 to 65 years and above 65 years. We will also be studying how quickly AZD5069 is absorbed into and cleared by the body.


Eligibility criteria: Inclusion Criteria:

* Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg.

Exclusion Criteria:

* Has participated in another clinical study and received drug treatment within 3 months of the first administration of drug in this study.
* Subjects with a past medical history of tuberculosis (TB).
* Subjects with latent or chronic infections

Primary outcomes:
measure: Pharmacokinetic blood to measure Maximum plasma concentration (Cmax); time to Cmax (tmax); and the area under the plasma concentration-time curve from zero to infinity (AUC).
timeFrame: 0 - 72 hours postdose
Secondary outcomes:
measure: Safety and tolerability of AZD5069 by assessing Adverse events, vital signs, electrocardiograms (ECGs), laboratory variables (including high sensitivity C-reactive protein [hsCRP] and circulating neutrophils), blood pressure, pulse rate, body temperature
timeFrame: various timepoints throughout the study from predose to follow-up
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Quintiles Drug Research Unit at Guy's Hospital
name: Darren Wilbraham, MBBS DCPSA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cullberg M, Arfvidsson C, Larsson B, Malmgren A, Mitchell P, Wahlby Hamren U, Wray H. Pharmacokinetics of the Oral Selective CXCR2 Antagonist AZD5069: A Summary of Eight Phase I Studies in Healthy Volunteers. Drugs R D. 2018 Jun;18(2):149-159. doi: 10.1007/s40268-018-0236-x.
Clinical trial NCT00543738: MK0767 and Metformin Combination Study (0767-028)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-15
Enrollment: 114
Sex: ALL
Minimum age (years): 21
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to test the effects of MK0767 when added to Metformin in patients with inadequately controlled Type 2 Diabetes Mellitus.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility criteria: Inclusion Criteria:

* All women of childbearing potential must have a negative urine pregnancy test prior to starting the study
* Patients must be on a stable dose of metformin for at least 2 weeks prior to visit 2

Exclusion Criteria:

* Patients with a history of type 1 diabetes mellitus and/or history of ketoacidosis
* Patients on estrogen replacement therapy regimen or SERM
* Patients with history of, allergy to, intolerance or hypersensitivity to statins or fibric acid derivatives, including history of elevated muscle and liver function tests, jaundice, hepatoxicity, or myopathy associated with these treatments
* Patient is on a weight loss program with ongoing weight loss or starting an intensive exercise program within 4 weeks from starting the study
* Have active liver or gall bladder disease
* HIV positive

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04584138: Autobiographical Memory
Official title: Eye Movement During Autobiographical Memory in Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Autobiographical Memory
Eye Movement
Memory
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Alzheimer's disease in the mild stage

Brief summary: This study aims at the assessment of eye movement during autobiographical retrieval (i.e., retrieval of personal memories) in patients with Alzheimer's Disease.

Detailed description: There is an increased interest in the study of eye movements during the retrieval of autobiographical memories and recent research has demonstrated how retrieval of autobiographical memory can activate eye movement. This research has been however mainly concerned with young adults and, until now, little is known about the relationship between eye movement and autobiographical memory in patients with Alzheimer's Disease. The aim of the current study is therefore to evaluate eye movements during the retrieval of autobiographical memories in patients with Alzheimer's Disease.

Eligibility criteria: Inclusion Criteria :

* Diagnosis of Alzheimer's Disease at the mild stage

Exclusion Criteria :

* Neurological/psychiatric disorders (other than Alzheimer's Disease)

Primary outcomes:
measure: Number of fixations and saccades
timeFrame: Four weeks (from assessment till analysis)
measure: Duration of fixations and saccades
timeFrame: Four weeks (from assessment till analysis)
Secondary outcomes:
measure: Pupil size
timeFrame: Four weeks (from assessment till analysis)
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
References:
citation: El Haj M, M J Janssen S, Gallouj K, Lenoble Q. Autobiographical Memory Increases Pupil Dilation. Transl Neurosci. 2019 Dec 19;10:280-287. doi: 10.1515/tnsci-2019-0044. eCollection 2019.
Clinical trial NCT02807038: Assessment of Exposures of the Mother-infant Pair to the Air Pollution of São Paulo
Official title: Longitudinal Study of the Pulmonary Function Testing of Pregnant Women Exposed to Air Pollution in São Paulo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Diseases
Keywords: Respiratory Function Tests
Air pollution
Pregnancy
Spirometry
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2016-06-21
Enrollment: 120
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 41
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A single group of pregnant women who was analyzed in the first and in the third trimesters of pregnancy

Detailed description: A single group of 120 pregnant women separated in smokers (n = 17) and nonsmokers (n = 103) and first pregnancy (n = 54) or multiparous (n = 66) who underwent pulmonary function test and used the individual passive sampler in the first and third trimesters of pregnancy

Eligibility criteria: Inclusion Criteria:

* prior informed consent;
* single pregnancy;
* topical and feasible;
* gestational age of less than 13.86 weeks at the first evaluation;
* absence of preexisting maternal diseases

Exclusion Criteria:

* withdrawal from the project;
* abortion;
* inadequate pulmonary function test

Primary outcomes:
measure: Effect of air pollution in the spirometry of 120 pregnants, evaluated by individual passive samplers in the first (T1) and third (T3) trimesters of pregnancy, using the non-parametric analysis for repeated measures
timeFrame: Through study completion, an average of 3 year
Secondary outcomes:
measure: Evaluation of the influence of smoking and parity and the results of spirometry of all pregnants exposed to pollution comparing the frequency of events held by Wilcoxon and the Mann Witney test
timeFrame: Through study completion, an average of 3 year
Other outcomes:
Locations:
Study officials:
affiliation: School of Medicine, University of São Paulo
name: Luciana Duzolina M Pastro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pastro LDM, Lemos M, Fernandes FLA, Saldiva SRDM, Vieira SE, Romanholo BMS, Saldiva PHN, Francisco RPV. Longitudinal study of lung function in pregnant women: Influence of parity and smoking. Clinics (Sao Paulo). 2017 Oct;72(10):595-599. doi: 10.6061/clinics/2017(10)02.