louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05615116: Clinical Study on the Distribution of Digestive Tract Microbiota Before and After Ileocecal Resection in Crohn's Disease
Official title: Clinical Study on the Distribution of Digestive Tract Microbiota Before and After Ileocecal Resection in Crohn's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn Disease
Microtia
Ileocecal; Lesion
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Crohn's patients before and after ileocecal resection were divided into two groups， the information of these individuals will be analyzed and some conclusions will be drawn.

Brief summary: In this study, the microbiota sequencing was used to investigate the changes of microbiota in the terminal ileum and the middle part of ascending colon, the mesenteric adipose tissue of ileum and ascending mesocolon, and oral cavity of patients with Crohn's disease before and after ileocecal resection, so as to further explore the role of ileocecal region in inducing remission of disease.


Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of Crohn's disease

Exclusion Criteria:

Serious oral diseases (e.g. dental caries, periodontal disease) Other acute or chronic gastrointestinal diseases Probiotics or prebiotic consumption and antibiotic use within 1 month

Primary outcomes:
measure: Microbial changes of intestinal mucosa
timeFrame: 6 month
Secondary outcomes:
measure: Microbial changes of mesenteric adipose tissue
timeFrame: 6 month
Other outcomes:
measure: Microbial changes of oral cavity
timeFrame: 6 month
Locations:
city: Shanghai
country: China
facility: Shanghai 10th People's Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT06947616: Effect of Mild Therapeutic Hypothermia on the Doses of Vasopressors and Inotropes in Cardiogenic Shock Complicating Acute Myocardial Infarction
Official title: Effect of Mild Therapeutic Hypothermia on the Doses of Vasopressors and Inotropes in Cardiogenic Shock Complicating Acute Myocardial Infarction: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Therapeutic Hypothermia
Cardiogenic Shock
Acute Myocardial Infarction
Vasopressors
Inotropes
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to assess the effects of mild therapeutic hypothermia (MTH) on vasopressors and inotropes in patients with cardiogenic shock (CS) due to acute myocardial infarction (AMI).

Detailed description: Cardiogenic shock (CS) is a condition characterized by a severe lack of blood flow to vital organs caused by primary malfunction of the heart, as described by the European Society of Cardiology (ESC) and the American Heart Association (AHA). Acute myocardial infarction (AMI) is a prevalent etiology of CS, constituting a minimum of 30% of the instances. 50% of CS cases manifest upon hospital admission, whereas the remaining 50% occur after hospital admission.

Eligibility criteria: Inclusion Criteria:

* Age from 50 to 70 years.
* Both sexes.
* Cardiogenic shock post AMI defined by systolic blood pressure \<90 mm Hg for \>30 minutes or motropes required to maintain a systolic blood pressure \>90 mm Hg in the absence of hypovolemia with signs of pulmonary congestion and signs of impaired organ perfusion defined by at least 1 of the following: altered mental status; cold, clammy skin; urine output \<30 mL/h; or arterial lactate \>2 mmol/L.

  2. Intubated and sedated

Exclusion Criteria:

1. Self-ventilated
2. Indication for targeted temperature management by current guidelines "out of hospital cardiac arrest with return of spontaneous circulation (ROSC)"

Primary outcomes:
measure: Incidence of stroke
timeFrame: 30 day after the procedure
Secondary outcomes:
measure: Duration of mechanical ventilation
timeFrame: Up to 7 days
measure: Length of intensive care unit stay
timeFrame: Up to 2 weeks after the procedure
measure: Duration of inotropic support
timeFrame: Intraoperatively
measure: Incidence of mortality
timeFrame: 30 days after the procedure
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT03987516: Active Intervention for Patients With Neck Pain
Official title: Effects of an Active Program in Patients With Chronic Neck Pain: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neck Pain
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 50
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: Neck pain is a complex biopsychosocial disorder often precipitated or aggravated by neck movements or sustained neck postures. More than 80 % of individuals experience neck pain and neck associated disorders. The aim of this study was to investigate the effects of a 4-week active exercising program in patients with chronic neck pain.

Detailed description: While neck pain can be severely disabling and costly, treatment options have shown moderate evidence of effectiveness. The optimal physiotherapy intervention is currently unclear. Consequently, more research in this area combining different techniques in patients with a specific clinical profile is needed. It has been previously shown that participants prefer self-care measures for the management of neck pain. The aim of this study was to investigate the effects of a 4-week active exercising program in patients with chronic neck pain.

Eligibility criteria: Inclusion Criteria:

* To suffer from chronic neck pain (at least 3 months' duration)
* Neck pain of at least 3 on a visual analogue scale.
* Participants' symptoms should be at least partly related to increased nerve mechanosensitivity in the neck and upper limb confirmed by the reproduction of participants' symptoms by median nerve upper-limb neurodynamic test.

Exclusion Criteria:

* Whiplash related neck pain.
* Previous cervical surgical intervention.
* Cognitive impairments which prevent them to follow instructions.
* Visual or acoustic limitations.

Primary outcomes:
measure: Changes in number of active trigger points
timeFrame: Changes from baseline to 4 weeks in the number of active trigger points assessed by palpation. The percentage of active trigger points is obtained.
Secondary outcomes:
measure: Severity of pain
timeFrame: Changes from baseline to 4 weeks in the severity of pain assessed using the Brief Pain Inventory. The severity and the interference of pain with daily life subscales were included. Score is the sum of the items divided by the number of items.
measure: Functionality
timeFrame: Changes from baseline to 4 weeks on functionality assessed using the Neck Outcome Score.Symptoms, sleep disturbance, every day activity and pain and participation in everyday life subscales were included. They Ranged from 0 to 100 (no simptoms).
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Department of Physical Therapy
Study officials:
References:
Clinical trial NCT01752816: Does Aerobic Training Followed by Resistance Training Enhance Aerobic Capacity in Seniors
Official title: Does Aerobic Training Followed by Resistance Training Enhance Aerobic Capacity in Seniors? A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Elderly
Keywords: endurance training,
strength training,
aerobic capacity,
muscle strenght
physical capacity
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2012-12-19
Enrollment: 33
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In healthy young subjects a single bout of strength training following endurance training has been shown to improve markers for aerobic capacity in muscle compared to a single bout of endurance training alone. The present project tests the hypothesis: 12 weeks of training with sessions of endurance training followed by strength training is superior to endurance training alone for health participants 50-65 years of age. The outcome measures are maximal oxygen uptake and knee-extension strength.


Eligibility criteria: Inclusion Criteria:

* healthy
* understanding Danish language

Exclusion Criteria:

* medical contraindication for training
* taking beta-blockers
* physical exercise training more than 2 hrs per week

Primary outcomes:
measure: maximal oxygen uptake
timeFrame: 12 weeks
measure: knee extension strength
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Næstved
country: Denmark
facility: Næstved Senior Motion klub
state: Sjælland
Study officials:
affiliation: University of Southern Denmark
name: Gisela Sjøgaard, DrMedSci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01004016: A Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Official title: A Double-blind, Placebo-controlled, Crossover Study, Followed by Open-label Study of KPS-0373 in Patients With SCD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spinocerebellar Degeneration
Keywords: Spinocerebellar degeneration
Thyrotropin-Releasing Hormone (TRH)
SCD
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-10-29
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of KPS-0373 in patients with SCD.


Eligibility criteria: Inclusion Criteria:

* Japanese SCD patients with mild to moderate ataxia

Exclusion Criteria:

* Patients with secondary ataxia
* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Primary outcomes:
measure: Scale for Assessment and Rating of Ataxia (SARA)
timeFrame: 4 weeks + 12 weeks
measure: Upper and lower extremity function
timeFrame: 4 weeks + 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Japan
country: Japan
facility: Japan
Study officials:
affiliation: Clinical Development Department, Kissei Pharmaceutical Co., Ltd.
name: Yasuhiro Omori
role: STUDY_DIRECTOR
References:
Clinical trial NCT05123716: Drug Effects on Interpersonal Interaction
Official title: Drug Effects on Interpersonal Interaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Interaction, Social
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators propose to use a Paired Partner design, in which subjects engage in a 45-min semi-structured conversation with one (novel) partner under the influence of MDMA and with another partner under the influence of placebo. At the end of each session, they will rate their feelings about the partner, and on the test day, subjects will be asked which partner they preferred and felt closer to.

Detailed description: The study will use a within-subject design with three sessions: i) MDMA and conversation with Person A, ii) placebo and conversation with Person B, iii) test session (online) assessing preference for Persons A and B. The MDMA dose will be 100 mg, administered under double blind conditions. The conversation will consist of a 45 min dialog between the participant and the partner, a person trained to engage in conversation for this purpose. The dyad will be provided with topics to discuss, at their own pace. The order of administration of drug and placebo will be counterbalanced, and the partners will be same-sex and varied across sessions. The primary outcome measures will be feelings of closeness and connection at the end of the two drug sessions, at the online test session and follow-up. After study completion, participants will be fully informed about the study.

Eligibility criteria: Inclusion Criteria:

* English fluency
* High school level education
* BMI between 19 and 30

Exclusion Criteria:

* Diagnosed medical condition
* women who are nursing, pregnant, or plan to become pregnant within 3 months
* History of psychotic disorder or family history of psychotic disorder

Primary outcomes:
measure: Profile of Mood States
timeFrame: Time Frame: Baseline-72 hours after completion of the sessions
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
References:
Clinical trial NCT04177316: Hypermethylation of VTRNA2-1 Promoter in HCC Outcome
Official title: Differential Hypermethylation Status of the VTRNA2-1 Promoter in Hepatocellular Carcinoma as an Independent Factor After Partial Hepatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma Resectable
Keywords: VTRNA2-1 promoter
recurrence
methylation
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 92
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HCC patients with curative partial hepatectomies and the pathology reports proved.

Brief summary: The clinic-pathological data were retrieved from the cancer registry database from the Cancer Center of Chang Gung Memorial Hospital, Linkou branch. Of the 92 HCC patients with partial hepatectomies enrolled. The biological specimen was studied with approval.

Detailed description: This study was approved by the Institute Review Board (IRB) of Chang Gung Memorial Hospital, Linkou Branch (IRB 201801969B0). The clinic-pathological data were retrieved from the cancer registry database from the Cancer Center of Chang Gung Memorial Hospital, Linkou branch. Of the 92 HCC patients with partial hepatectomies enrolled, all patients had curative hepatectomy and those with different cancers were excluded. HCC tumor tissue and normal tissue, 3 cm from the tumor margin, were stored immediately in a -80 degree freezer at the Central Biobank of Chang Gung Memorial Hospital. The personal information was protected with decoding and registered with number.

Eligibility criteria: Inclusion Criteria:

subjects with pathologic diagnosis of hepatocellular carcinoma curative partial hepatectomies

Exclusion Criteria:

history of different malignant disease. subjects cannot be treated with curative surgery.

Primary outcomes:
measure: disease free survival (DFS)
timeFrame: a month
Secondary outcomes:
measure: Overall survival
timeFrame: a month
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Ming-Chin Yu
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Ming-Chin Yu, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05776316: Harm Reduction Services
Official title: Culturally Response Integrated Harm Reduction Services for Black and Latinx People Who Use Drugs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Drug Use
Substance Abuse
Mental Illness
Keywords: Harm Reduction
Latinx/Hispanix
Black/African American
Drug Use
Cocaine
Opioids
Methamphetamines
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2023-03-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to assess whether an integrated harm reduction intervention (IHRI), compared to harm reduction (HR) services as usual, will improve harm reduction service utilization among Black and Latinx people who use drugs (PWUD).


Eligibility criteria: Inclusion Criteria:

* at least 18 years of age
* self-identified as misusing opioids +/- other substances (stimulants) in the past 30 days, confirmed by interview using DSM-5 criteria
* English or Spanish speaking
* able to provide informed consent.

Exclusion Criteria:

* inability to provide informed consent or participate in the study procedures as proposed in the consent
* active suicidal or homicidal ideation or an unstable psychotic disorder (schizophrenia, schizoaffective disorder) or mood disorder (bipolar disorder, severe major depressive disorder)
* an unwillingness to be randomized.
* are prisoners

Primary outcomes:
measure: Percentage of Participants who Attend At least 1 Harm Reduction (HR) Session after Introductory HR Session
timeFrame: Up to Week 8
measure: Percentage of Participants who Attend at least 3 HR Sessions in Total
timeFrame: Up to Week 8
Secondary outcomes:
measure: Change from Baseline in Number of Days of Opioid/Other Stimulant Use
timeFrame: Baseline, Week 8
measure: Change from Baseline in Overdose Risk Assessment Tool Score
timeFrame: Baseline, Week 8
measure: Change from Baseline in Brief Quality of Life Scale Score
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Orangeburg
country: United States
facility: Nathan Kline Institute
state: New York
Study officials:
affiliation: NYU Langone Health
name: Ayana Jordan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00820716: Exercise Training in Asthma
Official title: Comparison of Two Types of Exercise Training for Asthmatic Subjects : Interests and Limits
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Asthmatic subjects
Exercise training
Constant load
Alternate load
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2009-01-12
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to compare two methods of exercise training: alternate load versus constant load realized at moderate or high intensities, in order to define the interests and the limits of each one of these two methods. The finality is to make possible to the expert to choose what exercise training induces the best results quickly and to make its choice according to the therapeutic objectives which it lays down.We also evaluate the effects of these exercises training on the vagal response and the bronchial tone of the asthmatics. From a clinical point of view, a close attention will be paid to the effects of these exercises training on the control of asthma and the quality of life of the subjects


Eligibility criteria: Inclusion Criteria:

* 18 to 45 years old
* mild to moderate persistent asthma (GINA classification)
* stabilized asthma
* physical activity level between 5 and 11 (Baecke and coll, 1982)
* no contra-indication for physical training

Exclusion Criteria:

* cardiovascular pathology
* metabolic pathology
* traumatic pathology
* BMI≥30
* tobacco
* diabetes

Primary outcomes:
measure: Maximal oxygen consumption (VO2max)
timeFrame: At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
measure: Maximal power output (Pmax)
timeFrame: At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
Secondary outcomes:
measure: Exhaled NO (eNO)
timeFrame: At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
measure: Heart rate variability
timeFrame: At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
measure: Force Expiratory Volume in one second (FEV1)
timeFrame: At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Physiologie et d'Explorations Fonctionnelles - Pôle de Pathologie Thoracique - Nouvel Hôpital Civil
city: Strasbourg
country: France
facility: Service de Pneumologie - Pôle de Pathologie Thoracique - Nouvel Hôpital Civil
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Evelyne LONSDORFER, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01683916: Anesthetic Requirement and Stress Hormone Response During Surgery in Spinal Cord-injured Patients
Official title: Chonnam National University Hospital IRB
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complete Spinal Cord Injury
Surgery
Keywords: spinal cord injury
stress hormone
surgery
bispectral index value
volatile anesthetic
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2012-09-12
Enrollment: 45
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ASA physical status II, with chronic, clinically complete cord injuries scheduled for a surgery for pressure sore below the level of the neurologic lesion under general anesthesia.

Brief summary: Spinal cord injury (SCI) reduces anesthetic requirements and stress hormonal responses. Anesthetic requirements and stress hormone response are compared in SCI patients undergoing anesthesia with sevoflurane supplemented with clinically equivalent doses of either N2O or remifentanil.

Detailed description: Nitrous oxide (N2O) is often used for anesthetic adjuvant, but may be associated with side effects and toxicities. Remifentanil shares characteristics with N2O, including anesthetic-reducing and antinociceptive effects and a rapid recovery. Anesthetic requirements and stress hormone response in SCI patients undergoing anesthesia with sevoflurane supplemented with clinically equivalent doses of either N2O or remifentanil. Forty-five SCI patients scheduled to undergo pressor sore surgery below the level of the injury are randomly allocated to receive either sevoflurane alone (control, n=15), or combined with 67% N2O (n=15) or target-controlled infusions of 1.37 ng/mL remifentanil (n=15). Sevoflurane concentration is titrated to maintain a Bispectral Index (BIS) value of 40-50. Measurements include end-tidal sevoflurane concentrations, mean arterial blood pressure (MAP), heart rate (HR), and plasma catecholamine and cortisol concentrations.

Eligibility criteria: Inclusion Criteria:

* ASA physical status II, with chronic, clinically complete cord injuries scheduled for a surgery for pressure sore below the level of the neurologic lesion under general anesthesia.

Exclusion Criteria:

* Cardiovascular, pulmonary, or metabolic diseases. Patients who took medications that would influence autonomic or cardiovascular responses to the surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine
Study officials:
References: