louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00569088: Study of the Pathogenesis and Molecular Mechanism of "YURE" in Internal Intractable Diseases
Official title: "973" Project for Pathology of Traditional Chinese Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stroke
Keywords: hemorrhagic stroke
Chinese Medicine
pathogenesis
YURE
Lead sponsor: Nanjing University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2007-12-06
Enrollment: 300
Sex: ALL
Minimum age (years): 40
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 whether the Chinese herbs formula is effective in the treatment of hemorrhagic stroke and to find out Chinese pathogeny and pathogenesis in the disease.

Detailed description: Blood stasis and blood heat are two pathogens in the theory system of Chinese Medicine, which can cause many diseases independently. But in internal intractable diseases, such as viral hepatitis, stroke, and epidemic hemorrhagic fever, blood stasis and blood heat always accompany with each other. So the hypothesis is raised that blood stasis with heat (YURE) is a compound pathogen and key pathogenesis in internal intractable diseases. This study was aimed to verify the role that the compound pathogen played in hemorrhagic stroke and to observe the progress of the key pathogenesis. A randomized and controlled trial would be conducted in five hospitals, where 300 hospitalized patients with hemorrhagic stroke in the acute phase would receive different intervention with basic modern medicine treatment or Chinese herbs formula combined with the former. The Chinese herbs formula, which was designed under the guidance of the theory system of Chinese Medicine, was supposed to cool blood heat and dissolve blood stasis. Clinical efficacy and safety would be evaluated after the 21-days intervention.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of hemorrhagic stroke
* hospitalized in 48 hours after hemorrhagic stroke happens

Exclusion Criteria:

* Subarachnoid Hemorrhage
* intracranial hemorrhage caused by tumor, trauma or blood diseases

Primary outcomes:
measure: Chinese symptoms
timeFrame: 21 days
Secondary outcomes:
measure: blood loss determined by brain CT
timeFrame: 21 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Institute of Internal Intractable Diseases, Nanjing University of Traditonal Chinese Medicine
state: Jiangsu
Study officials:
affiliation: Nanjing Uinversity of Traditional Chinese Medicine
name: Mianhua Wu, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00892788: A Behavioral Intervention for Reducing Obesity
Official title: A Behavioral Intervention for Reducing Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Overweight
Obesity
Contingency Management
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: UCHC/Storrs and Regional Campus Incentive Grants
First posted: 2009-05-05
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine a contingency management (CM) intervention designed to provide incentives for losing weight versus participating in a manual-guided behavioral weight loss intervention alone. Participants in the CM condition will earn the opportunity to win prizes by losing weight and completing activities that contribute to weight loss, such as keeping daily food and physical activity diaries, choosing healthy foods, exercising, and using other weight loss strategies. The investigators will determine if the CM improves weight loss relative to the usual care manual-guided intervention alone.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 65 years
* body mass index in kg/m2 (BMI) between 30.0 and 39.9
* seated blood pressure of 100/60-140/90 mmHg
* ability to speak English and read at the 6th grade level
* willingness to be randomly assigned to one of two groups

Exclusion Criteria:

* any serious acute or chronic medical problems that may impact dietary or exercise regimens or impact weight loss
* psychiatric exclusions

Primary outcomes:
measure: absolute and relative weight loss
timeFrame: Weeks 1-12
measure: changes in waist circumference
timeFrame: Week 1 and Week 12
measure: proportion of participants achieving clinically significant weight loss (5% or more of baseline weight)
timeFrame: Week 1 and Week 12
Secondary outcomes:
measure: indices of treatment retention
timeFrame: Weeks 1-12
measure: changes on measures of diet quality, physical activity, and physiological parameters such as blood pressure, lipoproteins, insulin, and glucose levels
timeFrame: Week 1 and Week 12
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Nancy M Petry, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01302288: Endolumenal Partial Myotomy for the Treatment of Esophageal Achalasia
Official title: Endoscopic Submucosal Tunnel Dissection for Endolumenal Partial Myotomy of the Lower Esophageal Sphincter for Achalasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Achalasia
Keywords: endolumenal myotomy, per oral endoscopic myotomy
Lead sponsor: The Oregon Clinic
Sponsor class: OTHER
First posted: 2011-02-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Achalasia is a primary esophageal motility disorder where the lower esophageal sphincter fails to relax in response to swallowing with no well understood underlying cause. Surgical myotomy represents an appropriate therapeutic option. The purpose of this study is to evaluate flexible endoscopic myotomy, a novel therapeutic approach to overcome the need for invasive surgery.

Detailed description: In this study, the investigators propose the use of a recent endolumenal technique for partial myotomy in patients suffering from esophageal achalasia.

Under general anesthesia patients will have upper endoscopy. Submucosal injection and mucosal incision is created for entry into the submucosal space. A submucosal tunnel is then created using a needle knife or blunt dissection as appropriate. Dissection will continue distally beyond the lower esophageal sphincter. The inner circular muscle fibers will then be divided to achieve an adequate myotomy length. The mucosal entry is then closed appropriately.

Results will be compared to historical data of conventional Heller myotomies.

Eligibility criteria: Inclusion Criteria:

* Candidate for elective Heller myotomy
* Ability to undergo general anesthesia
* Ability to give informed consent

Exclusion Criteria:

* Previous mediastinal or esophageal surgery
* Contraindications for EGD

Primary outcomes:
measure: Esophageal function testing
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life score
timeFrame: 6 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Good Samaritan Hospital, Legacy Health System
state: Oregon
Study officials:
References:
citation: Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.
Clinical trial NCT03699488: Messaging Therapy for Depression and Anxiety: A Longitudinal Effectiveness Study
Official title: Asynchronous Messaging Therapy for Depression and Anxiety: A Longitudinal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Symptoms
Anxiety Disorders
Keywords: technology
messaging psychotherapy
depression
anxiety
telehealth
Lead sponsor: Talkspace
Sponsor class: INDUSTRY
Collaborators: name: Columbia University
name: New York University
First posted: 2018-10-09
Enrollment: 12980
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals seeking psychotherapy services through digitally-mediated application who present with and are diagnosed with a depression and/or anxiety related disorder.

Brief summary: Therapies delivered via technology have been developed to improve accessibility, however, there is limited research regarding messaging therapy in particular, and none that we know of utilizing a longitudinal effectiveness design. The aim of this study was to investigate the overall effectiveness of messaging therapy, identify any contributors to its effectiveness, and to evaluate a dosage effect for this type of treatment.


Eligibility criteria: Inclusion Criteria:

* Diagnosed Depression and/or Anxiety Disorder

Exclusion Criteria:

* Any psychosis related symptoms or disorders

Primary outcomes:
measure: Change from Baseline in Depressive symptoms on the Patient Health Questionnaire - 9
timeFrame: Up to 52 weeks
measure: Change from Baseline in Anxiety symptoms on the Generalized Anxiety Disorder - 7
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Mean number of words sent from patient to therapist
timeFrame: Up to 52 weeks
measure: Mean number of words sent from therapist to patient
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: New York University
name: Matteo Malgaroli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hull TD, Malgaroli M, Connolly PS, Feuerstein S, Simon NM. Two-way messaging therapy for depression and anxiety: longitudinal response trajectories. BMC Psychiatry. 2020 Jun 12;20(1):297. doi: 10.1186/s12888-020-02721-x.
Clinical trial NCT00968188: Internet-based HIV/STI Prevention for Young MSM Receiving HIV Testing
Official title: A Randomized Control Trial of an Internet-based HIV/STI Prevention for Young MSM Receiving HIV Testing.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
HIV Infections
Keywords: HIV Risk
Internet Intervention
Homosexuality, Male
HIV Seronegativity
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-08-28
Enrollment: 102
Sex: MALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to develop an empirically validated, scientifically-based HIV and STI prevention program that can be delivered online to young men who have sex with men (YMSM) who were recently tested for HIV.

Detailed description: Presently, there are a limited number of proven HIV interventions culturally tailored to young men who have sex with men (YMSM). This is alarming because Men who have sex with men comprise 68% of HIV/AIDS diagnoses in men, despite representing a much smaller proportion of the population. In addition, MSM are reporting more sexual risk behavior than in previous years and there is significant concern that HIV infection rates may once again be on the rise after more than a decade of remaining relatively stable.

The Internet is a viable intervention avenue because of it's high percentage of accessibility and usage, especially among young adults. Moreover, it might hold a strong appeal for YMSM, since its anonymity confers a sense of perceived safety against stigma surrounding HIV prevention information.

The purpose of this study is to compare two different versions of an online HIV/STI intervention for YMSM. This study is part of an overall program of research designed to understand and prevent HIV infection among high-risk youth. Participation in this study will help us to determine the usefulness of an tailored and interactive HIV Internet-assisted intervention.

Eligibility criteria: Inclusion Criteria:

* Between 18 and 24 years of age
* Self-identify as a biological male
* Understand and read English
* Have tested HIV negative at an approved clinic within 6 weeks
* Report at least one (male) sex partners in the past three months, and unprotected anal sex with at least one male sex partner in the past three months.

Exclusion Criteria:

* Have been diagnosed with HIV within the past three months
* Participation in another HIV prevention program
* No access to the Internet or an email address

Primary outcomes:
measure: Sexual Risk Behavior
timeFrame: 3 months
Secondary outcomes:
measure: HIV knowledge, Decisional Balance, condom errors, safer sex self-efficacy, intentions
timeFrame: 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Howard Brown Health Center
state: Illinois
Study officials:
affiliation: Northwestern University
name: Brian S Mustanski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06528288: Effects of Erector Spinae Plane Block on Postoperative Pain Following Lumbar Fusion Surgery
Official title: Opioid Usage and Patient Reported Outcome Comparison Following Erector Spinae Plane Block or Subcutaneous Anesthetic in Spinal Fusion Procedures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fusion of Spine, Lumbar Region
Anesthesia, Local
Pain, Postoperative
Opioid Use
Keywords: Erector Spinae Plane Block
Spinal Fusion
Patient Reported Outcomes
Opioid Usage
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 66
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: The purpose of this study is to determine if the method for injecting local anesthesia affects patients' pain and opioid usage after surgery. The investigators will compare subcutaneous anesthesia, injections of anesthesia under the skin, to a method called erector spinae plane block (ESPB). An ESPB injection involves placing local anesthesia along the muscles and bones in the back, using a special type of x-ray called fluoroscopy for guidance. The Investigators will use patient reported outcomes (PROs) and track subjects' opioid usage to find out if there is a difference between ESPB and subcutaneous anesthesia. The investigators hypothesize that patients who get ESPB injections will use less opioids and report less pain after lumbar fusion surgery compared to patients who receive subcutaneous anesthesia injections.


Eligibility criteria: Inclusion Criteria:

* The individual has signed and dated a study specific informed consent form approved by the Institutional Review Board at UMMHC.
* The individual is at least 18 years of age.
* The individual is skeletally mature (over the age of 18).
* The patient is scheduled for a one or two level lumbar spinal fusion.

Exclusion Criteria:

* Patients unable to consent for themselves.
* Pregnant women.
* Non-English speaking subjects.
* Prisoners.
* Spinal fusion procedures for a diagnosis of fracture, tumor, and/or infection.
* Patients who have used greater than 150 morphine milligram equivalents of opioids in the month prior to their operation.
* Patients with a body mass index (BMI) of 40 or greater.

Primary outcomes:
measure: MOS 36 Item Short Form Health Status Survey (SF-36)
timeFrame: 3 months
measure: Oswestry Disability Index
timeFrame: 3 months
measure: Postoperative Opioid Usage
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Chan Medical School/UMass Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: UMass Chan Medical School
name: Michael Stauff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00760188: Prospective Data Collection on Cementless Oxford Partial Knee
Official title: Prospective Clinical Evaluation of the Cementless Oxford Partial Knee
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Arthroplasty, Replacement, Knee
Keywords: knee replacement
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-09-26
Enrollment: 0
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: Patients Who Received Cementless Oxford Partial Knee for Its Indications for Use/Intended Uses - primary diagnoses in the medial compartment of the knee:

* Osteoarthritis,
* Avascular necrosis

Brief summary: Prospective data collection on clinical and radiographic outcomes of Cementless oxford Partial Knee.

Detailed description: Prospective radiographic and clinical data collection on outcomes of Cementless oxford Partial Knee. Screened radiographs are taken postoperatively and after 12 months. Oxford Knee Scores, SF12 Health Questionnaires and American Knee Society Radiographic Assessment are taken at 12 month follow-up.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing primary knee arthroplasty
2. Patients with one of the following primary diagnoses in the medial compartment of the knee:

   * Osteoarthritis,
   * Avascular necrosis

Exclusion criteria:

1. Inability to co-operate with and complete the study.
2. Inadequate fixation of cementless components. If either before or after randomization the surgeon feels that cementless fixation is inadequate, cemented components should be inserted.

Primary outcomes:
measure: American Knee Society Score
timeFrame: 1 yr
Secondary outcomes:
measure: Radiographic Assessment
timeFrame: 1yr
measure: Oxford Knee Score
timeFrame: 1 yr
measure: Short Form 12
timeFrame: 1 yr
Other outcomes:
Locations:
city: Penrith
country: Australia
facility: Rami Sorial , FRACS
Study officials:
affiliation: Zimmer Biomet
name: N Hunt
role: STUDY_DIRECTOR
References:
Clinical trial NCT00229788: Impact of Race and Re-Transplantation
Official title: Impact of Race and Re-Transplantation in Childhood: Analysis of Data From the United Network of Organ Sharing
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Orthotopic Heart Transplantation
Keywords: orthotopic heart transplantation
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-09-30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: For children who develop graft failure following cardiac transplantation, retransplantation is often considered. While some centers have reported equivalent results for retransplantation as compared to primary transplantation, this strategy remains controversial. We seek to examine outcomes following re-transplantation in children and identify risk factors for mortality. In addition, adult African-Americans have been reported to have lower survival following heart and other solid-organ transplantation. The relationship of recipient race to survival following pediatric heart transplantation has not previously been reported.

Detailed description: Objective 1: For children who develop graft failure following cardiac transplantation, retransplantation is often considered. While some centers have reported equivalent results for retransplantation as compared to primary transplantation, this strategy remains controversial. We seek to examine outcomes following re-transplantation in children and identify risk factors for mortality.

Objective 2: Adult African-Americans have been reported to have lower survival following heart and other solid-organ transplantation. The relationship of recipient race to survival following pediatric heart transplantation has not previously been reported.

Methods: We would like to review the United Network for Organ Sharing database. We plan on reviewing database records of heart transplantation subjects \<18 years of age from 1987 to 2004. Indications for retransplantation and patient race characteristics will be collected and evaluated. Analysis will be performed using proportional hazards regression controlling for other potential risk factors. The contribution economic disparity, insurance status and HLA mismatching to disparities in outcome will also be explored.

Eligibility criteria: Inclusion Criteria:

* orthotopic heart transplantation
* \< 18 years of age

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory University and Children's Healthcare of Atlanta
name: William Mahle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04773288: Handy Hygiene of Children: Understanding the Effect of Live Feedback on Handwashing Behavior
Official title: Handy Hygiene of Children: Understanding the Effect of Live Feedback on Handwashing Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Hygiene
Handwashing
Lead sponsor: Otto-Friedrich-University Bamberg
Sponsor class: OTHER
Collaborators: name: University of Turku
First posted: 2021-02-26
Enrollment: 127
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Objective of the randomized controlled trial is to assess the impact of a digital intervention on hand hygiene of young children. Children in intervention kindergartens / elementary schools will see live instructions and feedback on their current hand washing activity while washing hands. We hypothesize that the digital intervention will improve hand hygiene practices of children in kindergarten / elementary school.


Eligibility criteria: Inclusion Criteria:

* children aged between 2 and 7 years of age
* children attending kindergarten

Exclusion Criteria:

* none

Primary outcomes:
measure: Main effects of live feedback on handwashing of children
timeFrame: Up to 3 months
measure: Effect of one-time education session on handwashing of children
timeFrame: Up to 1 month
measure: Habit formation through live feedback on handwashing of children
timeFrame: Up to 3 months
measure: Habit formation through live feedback on handwashing of children
timeFrame: Up to 3 months
measure: Acquisition of competences of children
timeFrame: Up to 3 months
measure: Acquisition of competences of children
timeFrame: Up to 3 months
measure: Self-efficacy of children
timeFrame: Up to 3 months
measure: Attitude towards technology of parents
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: University of Turku
city: Bamberg
country: Germany
facility: Otto-Friedrich-University
Study officials:
affiliation: Otto-Friedrich-University Bamberg
name: Thorsten Staake, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Otto-Friedrich-University Bamberg
name: Joanna Graichen, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Otto-Friedrich-University Bamberg
name: Carlo Stingl, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turku
name: Sanna Salanterä, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turku
name: Anni Pakarinen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turku
name: Riitta Mieronkoski
role: PRINCIPAL_INVESTIGATOR
References: