louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01512875: S1119 Peruvian H. Pylori Water Contamination Study
Official title: Gastric Cancer and Helicobacter Pylori Infection in Lima, Peru: The Role of Water Contamination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
water contamination
Lima, Peru
Lead sponsor: SWOG Cancer Research Network
Sponsor class: NETWORK
Collaborators: name: University of Michigan
name: Hope Foundation
First posted: 2012-01-19
Enrollment: 107
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of the following districts of Lima, Peru: Brena, Chorrillos, Comas, El Agustino, La Victoria, Lince, Los Olivos, Miraflores, Puente Piedra, Rimac, San Isidro, San Juan de Lurigancho, San Luis, San Martin de Porres, Via El Salvador, Villa Maria del Triunfo.

Brief summary: The objective of this study is to elucidate the role of drinking water derived from the public source in Lima, Peru and transmission of H. pylori infection using genotypic techniques.

Detailed description: The objective of this study is to detect the presence of Helicobacter Pylori in the drinking water derived from the public network by molecular and genomic techniques in districts of Lima (Brena, Chorrillos, Comas, El Agustino, La Victoria, Lince, Los Olivos, Miraflores, Puente Piedra, Rimac, San Isidro, San Juan de Lurigancho, San Martin de Porres, Villa El Salvador, and Villa Maria del Triunfo) with high and low incidence of gastric carcinoma. The secondary objective of this study is to establish correlations between the findings in water and those of the stomach of patients with symptoms of dyspepsia who live in those districts.

Eligibility criteria: Inclusion Criteria:

* adults between the ages of 21-70 years old who have lived for more than 10 years in the Lima districts listed in protocol,
* who have a biopsy proven diagnosis of infection by H. pylori.
* participants must be in good general condition, mentally competent and able to provide informed consent;
* must not show evidence of dehydration or jaundice;
* must be willing to complete the patient questionnaires.
* participants must not have known allergies to any of the antibiotics used in the study.

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Detect H. pylori in public drinking water of Lima Peru
timeFrame: within 1 year of receving last sample
Secondary outcomes:
measure: Correlation of H. pylori in water and those of stomachs of patients with symptoms
timeFrame: Within 1 year of receiving last sample
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Universidad Peruana Cayetano Heredia
Study officials:
affiliation: SWOG Cancer Research Network
name: Manuel Valdivieso, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00431275: Study to Compare Two Formulations of CP-675,206 Monoclonal Antibody
Official title: An Open Label, Randomized Clinical Comparability Study Of The Current Liquid And Commercial Liquid Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Melanoma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-02-05
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label, 2-arm study in which patients are randomized to receive either the formulation that is being used in clinical trials or the formulation that will be used when if the drug becomes commercially available. The purpose of this study is to compare the pharmacokinetics of the two formulations.


Eligibility criteria: Inclusion Criteria:

* Stage III or Stage IV melanoma
* No evidence of disease following resection of melanoma lesions
* Recovered from all prior surgical or adjuvant treatment-related toxicities

Exclusion Criteria:

* History of chronic inflammatory or autoimmune disease
* History of inflammatory bowel disease

Primary outcomes:
measure: Pharmacokinetics: maximum plasma concentration of CP-675,206
timeFrame: 1 hour
measure: Pharmacokinetics: AUC, defined as the area under the concentration -time curve
timeFrame: Time 0 to Day 85
Secondary outcomes:
measure: Human-anti-human antibodies
timeFrame: 1 year
measure: Adverse events
timeFrame: 1 year
measure: Safety laboratory tests
timeFrame: 1 year
measure: Proportion of patients alive and free of disease at 1 year
timeFrame: 1 year
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Aventura
country: United States
facility: Research Site
state: Florida
city: Miami Beach
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: New York
country: United States
facility: Research Site
state: New York
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00567775: Comparison of Human Insulin to Insulin Inhalation Solution in Children With Type 1 Diabetes
Official title: Comparison of Pharmacokinetic Profiles of Human Soluble Insulin With Insulin Inhalation Solution in Paediatric Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-12-05
Enrollment: 27
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to compare the pharmacokinetic profile of two different methods of insulin administration in children with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* Treatment for at least 12 months
* HbA1c lesser or equal to 11.0%
* Body weight between 25 and 80 Kg
* Capable to use the device

Exclusion Criteria:

* Any diseases other than diabetes requiring prescriptive medication
* Known or suspected allergy to trial product or related products
* Active proliferative retinopathy as judged by the Investigator
* Recurrent severe hypoglycaemia as judged by the Investigator
* The receipt of any investigational drug within 4 weeks prior to this trial

Primary outcomes:
measure: Area under the serum insulin curve
timeFrame: from 0 to 5 hours post-dosing
Secondary outcomes:
measure: Maximum serum insulin concentration
timeFrame: in the interval from 0 to 5 hours post-dosing
measure: Time to maximum serum insulin concentration
timeFrame: in the interval from 0 to 5 hours post-dosing
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04467775: Sagittal Balance Through Ages
Official title: Sagittal Balance Through Ages
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Deformity
Keywords: Spinal Deformity
Low back pain
Sciatica
Cervico brachial neuralgia
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 2000
Sex: ALL
Minimum age (years): 5
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject having carried out a telecolonne or EOS type X-ray for spinal balance (low back pain, sciatica, cervico-brachial neuralgia, inequality of length of the lower limbs) in spinal surgery consultation

Brief summary: The parameters of the sagittal balance of the cervical, thoracic and lumbar spine vary according to the types of spino-pelvic organization (types 1-4 according to Roussouly). These parameters have been described as a function of age in previous scientific work without taking into account the pelvic anatomy (pelvic incidence and spino-pelvic organization). This work, carried out within the framework of a round table of the French Society of Spinal Surgery (SFCR), would make it possible to provide a more detailed repository of existing radiographic parameters.


Eligibility criteria: Inclusion criteria:

* Minor or major subject aged 5 to 100
* Subject having carried out a telecolonne or EOS type X-ray for spinal balance (low back pain, sciatica, cervico-brachial neuralgia, inequality of length of the lower limbs) in spinal surgery consultation
* Subject not having expressed its opposition, after information, to the re-use of its data for the purposes of this research.

Exclusion criteria:

* Subject with surgical history, fractures, osteoporotic packing, vertebral deformation (scoliosis, kyphosis, spondylolisthesis grades 2-5), vertebral osteolysis (spondylodiscitis, tumor or metastasis).
* Subject who expressed his opposition to participate in the study
* Subject under guardianship or curatorship
* Subject under judicial protection

Primary outcomes:
measure: Retrospective study of the radiographic parameters measured by the KEOPS software
timeFrame: files analysed retrospectily from from January 1, 2014 to December 31, 2019 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie du Rachis
Study officials:
References:
citation: Charles YP, Prost S, Pesenti S, Ilharreborde B, Bauduin E, Laouissat F, Riouallon G, Wolff S, Challier V, Obeid I, Boissiere L, Ferrero E, Solla F, Le Huec JC, Bourret S, Faddoul J, Abi Lahoud GN, Fiere V, Vande Kerckhove M, Campana M, Lebhar J, Giorgi H, Faure A, Sauleau EA, Blondel B; French Spine Surgery Society (SFCR). Variation of cervical sagittal alignment parameters according to gender, pelvic incidence and age. Eur Spine J. 2022 May;31(5):1228-1240. doi: 10.1007/s00586-021-07102-w. Epub 2022 Jan 6.
Clinical trial NCT06810375: Erector Spinae Versus Intercostal Nerve Blocks With Liposomal Bupivacaine for Analgesia in Thoracic Surgery
Official title: Erector Spinae Versus Intercostal Nerve Blocks With Liposomal Bupivacaine for Analgesia in Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Lung Cancers
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial compares efficacy in postoperative pain management in thoracic surgery between erector spinae block versus liposomal bupivacaine injections.


Eligibility criteria: Inclusion Criteria:

* Video assisted pulmonary resection, pleurodesis or decortication

Exclusion Criteria:

* Allergy to local anesthetics
* Patient undergoing bilateral surgery
* Surgery is emergent as deemed by the principal investigator

Primary outcomes:
measure: Postoperative pain control assessment
timeFrame: Up to 48 hours postoperatively
measure: Morphine equivalent assessment
timeFrame: Up to 72 hours postoperatively
Secondary outcomes:
measure: Postoperative pain control assessment
timeFrame: Up to 72 hours postoperatively
Other outcomes:
Locations:
city: Washington
country: United States
facility: The George Washington University Hospital
state: District of Columbia
Study officials:
References:
Clinical trial NCT04419675: The Course of Low Back Pain
Official title: The Course of Low Back Pain: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Type of Leg Pain (Radicular, Non-radicular)
Lifestyle (Sedentary Behavior and Physical Activity)
Start Back Screening Tool
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with low back pain contacting physical therapy for treatment of low back pain

Brief summary: This study aims to research the possible associations of education level, sedentary lifestyle, and type of low back pain (radicular vs non-radicular) with the course of low back pain and recovery rate.


Eligibility criteria: Inclusion Criteria:

* Low back pain
* Age 18 years or older

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Functional Limitations
timeFrame: Measurement at baseline
measure: Functional Limitations
timeFrame: Measurement at 6 weeks
measure: Functional Limitations
timeFrame: Measurement at 12 weeks
measure: Functional Limitations
timeFrame: Measurement at 26 weeks
measure: Functional Limitations
timeFrame: Measurement at 52 weeks
measure: Recovery rate
timeFrame: 26 weeks after inclusion
measure: Recovery rate
timeFrame: 52 weeks after inclusion
measure: Pain with Numeric Pain Rating Scale
timeFrame: measurement at baseline
measure: Pain with Numeric Pain Rating Scale
timeFrame: measurement at 6 weeks
measure: Pain with Numeric Pain Rating Scale
timeFrame: measurement at 12 weeks
measure: Pain with Numeric Pain Rating Scale
timeFrame: measurement at 26 weeks
measure: Pain with Numeric Pain Rating Scale
timeFrame: measurement at 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amersfoort
country: Netherlands
facility: Fysius Amersfoort
city: Arnhem
country: Netherlands
facility: Fysius Arnhem
city: Eindhoven
country: Netherlands
facility: Fysius Eindhoven
city: Nijmegen
country: Netherlands
facility: Fysius Nijmegen
city: Rotterdam
country: Netherlands
facility: Fysius Rotterdam
city: Winterswijk
country: Netherlands
facility: Fysius Winterswijk
Study officials:
References:
Clinical trial NCT00830375: Memantine Treatment of Compulsive Buying
Official title: Memantine Treatment of Compulsive Buying: An Open-Label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Compulsive Buying
Keywords: Buying
Shopping
Impulse Control
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2009-01-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an 8-week, open-labe study of memantine in the treatment of compulsive buying.

Detailed description: The goal of the proposed study is to evaluate the efficacy of memantine in the treatment of compulsive buying. Sixteen subjects meeting criteria for compulsive buying will receive 8 weeks of open-label memantine. The hypothesis to be tested is that memantine will be effective and well tolerated in patients with compulsive buying. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Eligibility criteria: Inclusion Criteria:

1. men and women age 18-65
2. current CB using the clinician-administered Structured Clinical Interview for Compulsive buying (SCI-CB)
3. buying behavior within 2 weeks prior to enrollment

Exclusion Criteria:

1. infrequent buying (i.e. less than one time per week) that does not meet proposed criteria for CB
2. unstable medical illness or clinically significant abnormalities on laboratory tests or physical examination at screen
3. history of seizures
4. myocardial infarction within 6 months
5. current pregnancy or lactation, or inadequate contraception in women of childbearing potential
6. a need for medication other than memantine with possible psychotropic effects or unfavorable interactions;
7. clinically significant suicidality;
8. current Axis I disorder determined by the SCID and SCID-compatible modules for impulse control disorders, except for nicotine dependence
9. lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any psychotic disorder determined by SCID
10. current or recent (past 3 months) DSM-IV substance abuse or dependence;
11. positive urine drug screen at screening
12. initiation of psychotherapy or behavior therapy within 3 months prior to study baseline
13. previous treatment with memantine
14. treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline

Primary outcomes:
measure: Yale Brown Obsessive Compulsive Scale Modified for CB (CB-YBOCS)
timeFrame: from study start to study end (8-weeks) and is Investigator rated
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Ambulatory Research Center
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jon Grant, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05130775: Measurement of Tricuspid Regurgitation Volume for Assessment of Tricuspid Regurgitation Using 3D Transesophageal Echocardiography
Official title: Measurement of Tricuspid Regurgitation Volume for Assessment of Tricuspid Regurgitation Using 3D Transesophageal Echocardiography
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Tricuspid Regurgitation
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 years and older with all grades of tricuspid regurgitation

Brief summary: This study is a prospective observational chart review. The aim of the study is to evaluate tricuspid regurgitation volume using 3D volumetric assessment as an accurate method for tricuspid regurgitation severity in comparison to VCA.


Eligibility criteria: Inclusion Criteria:

-All degrees of tricuspid regurgitation minimal, mild, moderate and severe will be included

Exclusion Criteria:

* Exclusion criteria will be non-sinus rhythm, more than mild pulmonary regurgitation, more than trace aortic regurgitation.

Primary outcomes:
measure: Tricuspid regurgitation volume
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT02079675: Study to Assess the Efficacy and Safety of SKI3246 in Subjects With Non-Constipation Irritable Bowel Syndrome
Official title: Multi-center, Randomized, Double Blinded, Parallel Group, Placebo-controlled, Phase II Trial to Assess the Efficacy and Safety of SKI3246 in Subjects With Non-Constipation Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-constipation Irritable Bowel Syndrome
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-03-06
Enrollment: 279
Sex: ALL
Minimum age (years): 20
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 determine the efficacy and safety of different doses of SKI3246 compared with placebo in the treatment of patients with irritable bowel syndrome with non-constipation.


Eligibility criteria: Inclusion Criteria:

* Have been diagnosed as non-constipation by ROME III.
* Patients who voluntarily signed written informed consent may participate in the study.

Exclusion Criteria:

* Pregnant or lactating female.
* Patients with a history of inflammatory bowel disease.
* Severe neurological or psychological disease
* History of allergic reaction to the medications used in this study
* Use of other investigational drugs within 30 days prior to the study.
* Patients that investigators consider ineligible for this study

Primary outcomes:
measure: Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)
timeFrame: 12 weeks
Secondary outcomes:
measure: Patient satisfaction using 5- Likert Scale
timeFrame: 4 weeks
measure: Subject Self Reported Adequate Relief of Pain
timeFrame: 4 weeks
measure: Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey
timeFrame: 12 weeks
measure: Visual Analog Scale (VAS)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SK Chemicals
Study officials:
affiliation: Gangnam Severance Hospital, Yonsei University College of Medicine
name: Hyo Jin Park, M.D.
role: STUDY_CHAIR
References: