louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01967329: CANHelp Working Group Treatment Trials
Official title: Canadian North Helicobacter Pylori (CANHelp) Working Group Treatment Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Innovates Health Solutions
name: ArcticNet
name: Canadian Institutes of Health Research (CIHR)
First posted: 2013-10-22
Enrollment: 338
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The CANHelp Working Group Treatment Trials are part of a comprehensive research program carried out by the Canadian North Helicobacter pylori (CANHelp) Working Group. The treatment component involves a series of community-specific trials designed with community input and varying on the specific treatment regimens and number of treatment arms among other study details.

Detailed description: The CANHelp Working Group is a collaborative team that links University of Alberta researchers with Canadian northern community leaders and health officials in a collaborative effort to investigate H. pylori infection with the goal of finding solutions to community concerns about health risks. The research program uses a community-driven research approach in northern communities to characterize the burden of disease from H. pylori infection and exchange knowledge with community members and decision makers to identify ways to reduce health risks from this infection.

For the participating communities, the treatment trials aim to:

1. Estimate the effectiveness of alternate H. pylori treatment regimens to identify optimal regimens for the local setting
2. Identify factors external to the treatment regimen that influence short- and long-term treatment success

Eligibility criteria: Inclusion Criteria:

* Over 15 years of age
* Identified as H. pylori infected with a positive urea breath test and/or biopsy-based evidence of H. pylori infection

Exclusion Criteria:

* Allergy to amoxicillin, metronidazole or clarithromycin
* Antibiotic therapy within 4 weeks prior to randomization
* Pregnant or breastfeeding
* Severe cardio-respiratory, pulmonary, endocrine, hepatic or renal disease

Primary outcomes:
measure: Post-treatment H. pylori status by urea breath test
timeFrame: A minimum of 10 weeks after participant has completed treatment
Secondary outcomes:
measure: Adherence to treatment regimen
timeFrame: An expected average of 1 week after treatment is completed
Other outcomes:
measure: Frequency of adverse effects
timeFrame: From the time treatment is started to an expected average of 1 week after treatment is completed
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Karen Goodman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00121329: 4% Intrauterine Lidocaine Infusion for Pain Management in First Trimester Abortions
Official title: 4% Intrauterine Lidocaine Infusion for Pain Management in First Trimester Abortions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Pain with procedures
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2005-07-21
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Recent studies have investigated the use of local anesthetics (i.e. lidocaine, mepivacaine) to lessen the pain experienced with minor gynecologic procedures such as endometrial biopsy and office hysteroscopy. Local anesthetic injected into the uterine cavity has been demonstrated effective in some studies at decreasing patient pain associated with these intrauterine procedures at an anesthetic concentration of at least 2%. Based on this evidence, we hypothesized that an intrauterine lidocaine infusion may reduce patient pain during first trimester abortions.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* Good general health
* English speaking
* Confirmation of gestational age by ultrasound
* Body weight \> 100 lbs.
* Pregnancy \< 11 weeks

Primary outcomes:
measure: VAS scores during cervical dilation and uterine aspiration
Secondary outcomes:
measure: Patient satisfaction, symptoms, lidocaine levels
Other outcomes:
Locations:
city: Portland
country: United States
facility: Planned Parenthood of the Columbia Willamette
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Alison B Edelman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04319029: Assessment of Dyslipidemic Patients' Knowledge, Quality of Life, and Adherence
Official title: Assessment of Patients' Knowledge, Quality of Life, and Adherence for Medication in Dyslipidemia - a Randomized Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemias
Lead sponsor: Al-Rasheed University College
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A randomized, parallel two-arm interventional study, the patients were divided into 1:1 ratio, in which both groups offered optimal pharmacological therapy also one group (interventional) offered predesign pharmaceutical care plan aimed to improved patients knowledge, adherence, satisfaction, and quality of life, while the other group (non-interventional) received conventional pharmaceutical care plan.


Eligibility criteria: Inclusion Criteria:

Patients diagnosed with dyslipidemia and received at least one statin therapy (in the previous 6 months), and patients on the same class of pharmacological therapy (statins).

Exclusion Criteria:

1. Pregnant women
2. Nephrotic syndrome
3. Active steroid user
4. Hypersensitivity for any mediation during the trial
5. History of a major cardiovascular event in the previous 3 months
6. Patients with mental disease or disability
7. Had a stroke in the previous 6 months

Primary outcomes:
measure: Change in the patient satisfaction
timeFrame: Baseline, and At 6 months
measure: Change in the medication adherence in intervention group vs. non-intervention group
timeFrame: Baseline, at 3 months, and at 6 months
measure: Change in the hyperlipidemia-Patient Knowledge in intervention group vs. non-intervention group
timeFrame: Baseline, and At 6 months
measure: Change in the quality of life in intervention group vs. non-intervention group
timeFrame: Baseline, and At 6 months
Secondary outcomes:
measure: Change in Serum LDL in intervention group vs. non-intervention group
timeFrame: Baseline, and At 6 months
measure: Change in Serum HDL in intervention group vs. non-intervention group
timeFrame: Baseline, and At 6 months
measure: Change in Serum cholesterol in intervention group vs. non-intervention group
timeFrame: Baseline, and At 6 months
measure: Rate of Medication-related problems manged
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Al-Rasheed University College
state: AL-Adhmia
Study officials:
affiliation: Al-Mustaffa University College
name: Hayder F Al-Tukmagi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Al-Rasheed University College
name: Hayder A Fawzi, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05268029: Making HD Voices Heard
Official title: Making HD Voices Heard - A Pilot Study on the myHDstory™ Platform
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Huntington Disease
Lead sponsor: Huntington Study Group
Sponsor class: NETWORK
First posted: 2022-03-07
Enrollment: 698
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who have been diagnosed with Huntington disease.

Brief summary: The Pilot Study, Making HD Voices Heard, will ask people living with HD to report what they experience and how they function.

Detailed description: The Huntington Study Group (HSG) myHDstory™ Platform is an online, observational research platform that will host the Pilot Study, Making HD Voices Heard. The Pilot Study will ask people living with HD to report what they experience and how they function. Participants will provide self-reported information using their own compatible smartphones, laptops, desktops, or tablets. Participants will be asked to reply to a series of questions, including open-ended questions that will be transcribed by voice (microphone voice-to-text transcription) or keyboard-entered text to record what they experience in their own words.

Eligibility criteria: Inclusion Criteria:

* Adults age 18 years and older
* Willing and able to provide informed consent electronically.
* Individuals answering as a participant must self-report they have been diagnosed with HD by a doctor.
* Ability to answer online questions or direct someone else to enter answers for them.
* Ability to ambulate independently and take care of some of his or her personal needs.
* Ability to read and understand English.
* Willing to create a unique identifier based on personal demographic information.
* Residing in the United States or its territories
* Owning or having access to an electronic device and secure internet connectivity

Exclusion Criteria:

An individual who does not meet all the inclusion criteria will be excluded from participation in this study.

Primary outcomes:
measure: The ability to successfully consent and enroll at least 200 HD participants who have early to mid-stage manifest HD.
timeFrame: 3 months
measure: Participants' ability to successfully complete online self-reported questionnaires.
timeFrame: 3 months
measure: Utility and informativeness of data collected.
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Huntington Study Group
state: New York
Study officials:
affiliation: Georgetown University
name: Karen E Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01759329: Health Effects of Coffee Consumption
Official title: Health Effects of Coffee Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: overweight
body weight
coffee
Lead sponsor: West German Center of Diabetes and Health
Sponsor class: OTHER
Collaborators: name: Tchibo GmbH
First posted: 2013-01-03
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Epidemiological studies have indicated a positive health impact of coffee. Nevertheless, intervention studies testing the effect of daily coffee consumption over a longer period are lacking so far. Moreover, there is a lack of knowledge about the properties of different coffees and their influence on weight development. Therefore, we tested the effect of two coffees differing in their alkyl pyridine content over a period of 3 months on weight development.

Detailed description: Participants were randomly associated to two groups, a test coffee group and a control coffee group. After coffee abstinence of 1 months, participants in both groups got a coffee machine and coffee pads for three months. Clinical data have been assessed before and after coffee abstinence and after 3 months of coffee consumption.

Eligibility criteria: Inclusion Criteria:

* age 18-69 years
* BMI ≥27 kg/m2
* coffee consumption of ≥3 cups per day

Exclusion Criteria:

* new diagnosed type 2 diabetes during the last 6 months
* severe diseases with hospital stay during the last 3 months
* change of body weight of more than 2 kg per week during the last 4 weeks
* smoking cessation during the last 3 months or planned during the study
* acute infects
* chronical diseases with except of type 2 diabetes mellitus
* regular pharmacological therapy with except of oral antidiabetic medication or contraception
* lack of contraception in women
* breastfeeding
* physical activity of more than 1 hour per day

Primary outcomes:
measure: body weight
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: West German Center of Diabetes and Health
Study officials:
affiliation: WDGZ
name: Stepahn Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kempf K, Kolb H, Gartner B, Bytof G, Stiebitz H, Lantz I, Lang R, Hofmann T, Martin S. Cardiometabolic effects of two coffee blends differing in content for major constituents in overweight adults: a randomized controlled trial. Eur J Nutr. 2015 Aug;54(5):845-54. doi: 10.1007/s00394-014-0763-3. Epub 2014 Sep 10.
Clinical trial NCT02752529: The Establishment of Multiple Point Prediction Model About Tacrolimus Metabolic Differences Based on Genetic Network After Liver Transplantation and the Application of Multicenter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cirrhosis, Liver
Keywords: Liver Transplantation
Individualized Therapy
Polymorphism
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-04-27
Enrollment: 415
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: Combined with the clinical data of FK506 and the database of GO and Kyoto Encyclopedia of Genes and Genomes（KEGG）, the investigators aim to carry out the bioinformatic analysis and build a muti-locus genetic model, then muti-center assess the predictive accuracy of FK506 metabolic differences.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of end-tage liver diseases
* 18 years old or above
* Han nationality
* Therapeutic regimen：TAC

Exclusion Criteria:

* Less than 18 years old
* Other races
* Therapeutic regimen：cyclosporine

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of Tacrolimus
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References:
citation: Ou B, Liu Y, Zhang T, Sun Y, Chen J, Peng Z. TLR9 rs352139 Genetic Variant Promotes Tacrolimus Elimination in Chinese Liver Transplant Patients During the Early Posttransplantation Period. Pharmacotherapy. 2019 Jan;39(1):67-76. doi: 10.1002/phar.2204. Epub 2019 Jan 8.
citation: Zhang T, Liu Y, Zeng R, Ling Q, Wen P, Fan J, Peng Z. Association of donor small ubiquitin-like modifier 4 rs237025 genetic variant with tacrolimus elimination in the early period after liver transplantation. Liver Int. 2018 Apr;38(4):724-732. doi: 10.1111/liv.13597. Epub 2017 Oct 4.
Clinical trial NCT02938429: Physical Activity Measured Through Accelerometers and Its Association With Endothelial Function in Young Patients With Fontan Physiology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Defects
Keywords: congenital
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 25
Sex: ALL
Minimum age (years): 24
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study will be a cross sectional assessment of physical activity as measured through accelerometers and its association with endothelial function of children with Fontan circulation and healthy age and gender matched controls who are followed at the University of Alberta - Stollery Children's hospital.


Eligibility criteria: Inclusion Criteria:

1. Children with Fontan physiology between the ages 24 months to 18 years at the Stollery Children's Hospital
2. Informed written consent obtained prior to enrolment
3. At least 6 months post Fontan procedure

Exclusion Criteria:

1. Patient hospitalized within the previous 2 weeks
2. Patient unable to ambulate independently
3. Underwent coarctation of the aorta repair using a subclavian flap.

Primary outcomes:
measure: Physical activity measured by accelerometers
timeFrame: Once consent/assent is obtained, participants will be asked to wear an Actigraph GT3X+ accelerometers for seven consecutive days, during waking hours.
measure: Endothelial function measured by Digital Thermal Monitoring (DTM) via the automated, operator-independent protocol (VENDYS-6000, Endothelix Inc., Houston, TX) and the Endothelial Pulse Amplitude Test (Endo-PAT, Itamar Medical).
timeFrame: Once consent/assent is obtained, endothelial function will be measured one time during a routine clinical visit.
Secondary outcomes:
measure: Vascular health questionnaire
timeFrame: Once during routine clinical visit after informed consent/assent.
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Jennifer Conway, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04584229: Chemsex, Perceived Risks and Coping Strategies.
Official title: Chemsex Among Men Who Have Sex With Men : Perceived Risks and Coping Strategies, a Qualitative Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexual; Sexual Desire
Illicit Drugs
MSM
Keywords: screening
MSM
Qualitative research
HIV transmission
men who have sex with men
Risk Reduction Behavior
Harm Reduction
recreational drugs
Sexualised drug use
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: men who have sex with other men

Brief summary: The research hypothesis is that access to prevention and harm and risk reduction associated with the use of psychoactive substances in a sexual context is insufficient for MSM practicing chemsex. This would lead to a lack of awareness of the risks taken and insufficient or inadequate strategies to protect themselves.

This qualitative study has a comprehensive objective. The aim is to identify the risks perceived by MSM practicing Chemsex and their coping strategies. The study is based on individual semi-directed interviews and focus group. The criteria for inclusion are: an age greater than or equal to 18 years, being a man having sex with men and having used psychoactive substances in a sexual context at least once in the past 12 months. Participants were recruited through a gay geo-social networking app on mobile phones on a voluntary basis. At the same tim+e, flyers presenting the study are also distributed to the "chemsex" consultations at the Montpellier University Hospital in France as well as to an association fighting against AIDS in Montpellier.

Data are subjected to an inductive method analysis, bringing out by constant comparison conceptualizing categories illustrating the experience and making it possible to identify and understand the risks felt and the coping strategies.


Eligibility criteria: Inclusion criteria:

* an age greater than or equal to 18 years
* being a man having sex with men
* having used psychoactive substances in a sexual context at least once in the past 12 months.

Exclusion criteria:

- to refuse to participate to the study

Primary outcomes:
measure: Chemsex Paretic Risk Assessment
timeFrame: 1 day
Secondary outcomes:
measure: Description of the population leaving Chemsex
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Hélène Donnadieu-Rigole, MD, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06798129: Use of Extracorporeal Blood Purification Therapies for Acute Poisoning
Official title: Use of Extracorporeal Blood Purification Therapies for Acute Poisoning in Jiangsu Province, China: a Multi-center Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Poisoning
Extracorporeal Blood Purification Therpay
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 4178
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: history of acute poisoning

Brief summary: Extracorporeal blood purification therapy, including intermittent hemodialysis (HD), continuous renal replacement therapy (CRRT), plasma exchange (PE), and hemoperfusion (HP) are potentially life-saving treatments for some poisonings. This study aimed to determine extracorporeal blood purification's effect on clinical outcomes in critically poisoned patients in Jiangsu Province, China.


Eligibility criteria: Inclusion Criteria:

* 12 years of age and older
* history of acute poisoning

Exclusion Criteria:

* missing records in survival outcome

Primary outcomes:
measure: Survival outcome
timeFrame: 28 days within the index date of presentation at emergency department
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT01265329: Methods for Objective Selection of Competent Sperm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sperm Selection
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2010-12-23
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In spite of the achievements and developement of the assisted reproduction techniques in the last years, there is still an elevated percentage of unsuccessful treatments, needing sometimes repeated attempts to reach pregnancy.

The molecular physiology of sperm is being better characterized, and some reports have demonstrated the implication of different molecular processes in the pathophysiology of male infertility.

Recently, different sperm selection methods have been based on these molecular differences, showing a better quality of the sperm population after selection.

The main objective of this research project is to clinically apply these techniques in order to increase the pregnancy rates per cycle in infertile couples attending assisted reproduction treatments.


Eligibility criteria: Inclusion Criteria:

MEN:

- \>3million sperm after swimming process

WOMEN:

* \< 37 YEARS OLD
* NO GYNECOLOGICAL ANOMOLIES
* HORMONAL VALUES WITHIN CLINICAL RANGE

Exclusion Criteria:

* NONE

Primary outcomes:
measure: Gestation
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: IVI Valencia
Study officials:
affiliation: IVI Valencia
name: Nicolas Garrido, PhD
role: PRINCIPAL_INVESTIGATOR
References: