louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02743884: Evaluating Heat Transfer With the Esophageal Cooling Device
Official title: Prospective, Interventional Study Evaluating Heat Transfer With the Esophageal Cooling Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-cardiac Surgery
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Cross-over.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: An esophageal heat exchange tube will be inserted in anesthetized surgical patients. Each patient will have 30 minutes of cooling (circulating fluid at 7 degrees C) and 30 minutes of warming (42 degrees C) with 15-minute recovery break in between. The primary outcome will be heat transfer, determined from inflow and outflow temperatures and fluid flow rate for cooling and warming modes.

Detailed description: The ECD is made with medical-grade silicone and has 3 ports; 2 coolant ports and a central port. The coolant ports of the ECD are connected to external heat exchanger while a third, central lumen simultaneously allows gastric decompression and drainage. The ECD can be inserted like a standard gastric tube.

The aim of this prospective, interventional study is to quantify heat transfer during warming and cooling using the Esophageal Cooling Device in anesthetized patients having non-cardiac surgery.

An esophageal heat exchange tube will be inserted in anesthetized surgical patients. Each will have 30 minutes of cooling (circulating fluid at 7 degrees C) and 30 minutes of warming (42 degrees C) with 15 -minute break in between; the order of the cooling and warming will be randomized. The primary outcome will be heat transfer, determined from inflow and outflow fluid temperatures and fluid flow rate assessed for both cooling and warming modes.

Eligibility criteria: Inclusion Criteria:

* Elective non-cardiac surgery;
* Age 18-80 years;
* Surgery expected to last \>2 hours;
* General anesthesia with endotracheal Intubation;
* Volatile anesthesia;
* BMI \< 38 kg/m2;
* ASA physical status 1-3.

Exclusion Criteria:

* Weight \< 45 kg;
* Unstable blood pressure;
* Known esophageal deformity or evidence of esophageal trauma or esophageal disease that in the opinion of the attending anesthesiologist precludes safe use of ECD.

Primary outcomes:
measure: Mean heat transfer at cooling, kcal/h
timeFrame: 15-60 minutes after intubation during elective non-cardiac surgery
measure: Mean heat transfer at warming, kcal/h
timeFrame: 15-60 minutes after intubation during elective non-cardiac surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Dept Chairman
name: Daniel Sessler, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT02729584: Gene Polymorphism of Taste Receptors and Circulating Endocannabinoids in Normal Weight and Obese Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutritional Physiological Phenomena
Lead sponsor: University of Cagliari
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera Brotzu
First posted: 2016-04-06
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: White Caucasians

Brief summary: The study aims at evaluating in normal weight and obese subjects those factors such as taste sensitivity and circulating endocannabinoids in influencing dietary choice and thereby lipid and energy metabolism in order to design personalized nutritional strategies.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI), range for normal weight subjects 17.5-24.95, for obese subjects 29.6-52.20
* No intake of nutritional supplements for at least six months before the trial

Exclusion Criteria:

* major diseases (diabetes, kidney disease, etc.),
* pregnancy or lactation;
* food allergies;
* the use of medications that interfere with taste or smell (e.g., steroids, antihistamines, certain antidepressants).

Primary outcomes:
measure: Endocannabinoid plasma levels
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00100984: A 48 Week Study Comparing Treatment With Saquinavir + Lopinavir/Ritonavir in Combination With Enfuvirtide HAART Versus Saquinavir + Lopinavir/Ritonavir + Other Nucleoside Combinations to See the Efficacy of These Treatments in Patients Infected With HIV-1
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: HIV Infection
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2005-01-10
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to compare the safety and efficacy of an enfuvirtide containing regimen to a nucleoside combination regimen. Resistance information will also be collected.


Eligibility criteria: Inclusion Criteria:

* CD4 cell count greater than 50 cells/mm\^3
* HIV-1 RNA viral load greater than or equal to 5000 copies/mL
* Patients must be HIV treatment experienced
* Patients diagnosed with HIV-1 infection

Exclusion Criteria:

* Female patients must not be able to have children or must be under effective contraceptives
* Female patients who are pregnant
* Have taken enfuvirtide and/or T-1249 before
* Have serious kidney problems
* Alcohol and/or drug abuse
* Have had an organ transplant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hobson City
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Washington, D.C.
country: United States
state: District of Columbia
city: Washington, D.C.
country: United States
state: District of Columbia
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Macon
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Jackson
country: United States
state: Mississippi
city: Saint Louis
country: United States
state: Missouri
city: Newark
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Huntersville
country: United States
state: North Carolina
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT00000484: Treatment of Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Diseases
Heart Diseases
Hypertension
Vascular Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 1999-10-28
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: To determine whether the long-term treatment of essential hypertension without significant target organ disease materially influenced mortality and/or cardiovascular renal morbidity.

Detailed description: BACKGROUND:

This grant-supported, cooperative, fixed-protocol clinical study was initiated in 1966 and followed a cooperative study of the treatment of renal hypertension initiated in 1960 to evaluate the relative efficacy of several recognized drug regimens for reduction of blood pressure. Six centers (USPHS hospitals) and a coordinating center were involved in the trial.

DESIGN NARRATIVE:

Randomized, double-blind, fixed sample. Three hundred and eighty nine eligible patients were assigned to drug therapy consisting of chlorothiazide plus Rauwolfia serpentina or to placebo.

The study completion date listed in this record was inferred from last publication listed in the Citations section of this study record.

Eligibility criteria: Men and women, ages 21-55. Mild essential hypertension (diastolic blood pressure over 90 mm Hg.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: USPHS Hospital
name: Anthony Damato
affiliation: USPHS Hospital
name: Richard Thurm
affiliation: USPHS Hospital
name: Christfried Urner
affiliation: USPHS Hospital
name: John Vaillancourt
affiliation: USPHS Hospital
name: J. Warbasse
affiliation: USPHS Hospital
name: Robert Wells
References:
citation: U.S. Public Health Service Hospitals Cooperative Study Group. Smith WM, et al: Intervention Trial in Mild Hypertension. Epidemiology and Control of Hypertension. Paul, O (Ed.), Symposia Specialists, Miami, l975, pp. 46l-483.
citation: Smith WM. Mild essential hypertension: benefit of treatment: discussion. Ann N Y Acad Sci. 1978 Mar 30;304:74-80. doi: 10.1111/j.1749-6632.1978.tb25573.x. No abstract available.
citation: Smith WM, Edlavitch SA, and Krushat WM: U.S. Public Health Service Hospitals Intervention Trial in Mild Hypertension. Hypertension, Determinants, Complications, and Intervention. Onesti G, and Klimt C, (Eds.), Grune & Stratton, New York, l979, pp. 38l-399.
citation: Smith WM: Hypertension--Effectiveness of Early Treatment in Preventing Sequellae. Proceedings of the Eisenhower Medical Center. Preventive Interventions in the Practice of Medicine, Spring, l979, pp. 8l-87.
citation: Smith WM, Edlavitch SA, and Krushat WM: Prevention of Stroke in Mild Hypertension: Public Health Service Hospitals Trial. Perspectives in Cardiovascular Research, Vol. 4. Prophylactic Approach to Hypertensive Diseases, Yamori Y, Lovenberg W, and Freis ED, (Eds.), Raven Press, New York, l979, pp. 53-62.
Clinical trial NCT06416384: Post-Dialysis Fatigue and Recovery Time in Hemodialysis Patients
Official title: The Effect of Hand Massage on Post-Dialysis Fatigue and Recovery Time in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hemodialysis
Fatigue
Massage
Keywords: hemodialysis patient
fatique
hand massage
nursing
recovery time
Lead sponsor: Amasya University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a randomized controlled, single-blind, experimental study.
Primary purpose: OTHER

Brief summary: This study aims to examine the effect of hand massage on patients receiving HD treatment on the severity of post-dialysis fatigue and post-dialysis recovery time.

Detailed description: After obtaining the necessary permissions for the research, informing the patients about the purpose, importance and method of the study by the researcher, and having the volunteer patients read and sign a consent form, the patients were randomly divided into two groups. Randomization of the groups was done in a computer environment.

Eligibility criteria: Inclusion Criteria:

* Those who are 18 years or older,
* Receiving hemodialysis treatment for at least 3 months,
* Receiving hemodialysis treatment three times a week,
* Does not have any open wounds in the area to be applied,
* No active fistula in the arm to be treated,
* Does not have a hearing impairment,
* Sufficient to understand the questions,
* Open to communication and cooperation,
* Volunteer and willing for research

Exclusion Criteria:

* Having an active oncological problem or receiving oncological treatment,
* Those with health problems that require contact isolation,
* The number of dialysis sessions changed during the study,
* Those who lost their lives while working,
* Those who had a kidney transplant during the study,
* Those who want to leave voluntarily at any stage of the study

Primary outcomes:
measure: fatigue severity
timeFrame: one week= first session
measure: recovery time
timeFrame: One week= first session
Secondary outcomes:
measure: fatique severity
timeFrame: After 4 weeks
measure: recovery time after dialysis
timeFrame: After 4 weeks
Other outcomes:
Locations:
city: Amasya
country: Turkey
facility: Amasya University İnstitute of Health Sciences
state: Merkez
Study officials:
affiliation: Amasya University
name: Eylem Topbaş, Phd
role: STUDY_DIRECTOR
affiliation: Amasya University health sciences institute
name: Seyit Ahmet KORKMAZ
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02122484: Colchicine in Coronary Artery Bypass Graft (CABG)
Official title: Study of Anti-inflammatory Treatment With Colchicine in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery to Reduce Reperfusion Damage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Elective Coronary Artery Bypass Graft Surgery
Keywords: reperfusion damage
Lead sponsor: G.Gennimatas General Hospital
Sponsor class: OTHER
Collaborators: name: Evangelismos Hospital
First posted: 2014-04-24
Enrollment: 60
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: TREATMENT

Brief summary: There is evidence that inflammatory processes may play a key role during surgical myocardial reperfusion. The hypothesis of this study is that colchicine, an anti-inflammatory agent, may lead to reduction in periprocedural infarct size, when administered during elective coronary artery bypass graft surgery.


Eligibility criteria: Inclusion Criteria:

* The study will enroll patients 18 years old or older who are eligible to undergo CABG surgery.

Exclusion Criteria:

Excluded are patients:

* with age \> 80 years old
* scheduled for concomitant valve surgery
* scheduled for coronary surgery without cardiopulmonary bypass
* with peripheral vascular disease aﬀecting the upper limbs
* with acute coronary syndrome within the previous 4 weeks
* on inotropic or mechanical circulatory support before induction of anaesthesia
* with any disorder that could potentially increase preoperative cTnI concentrations (eg, percutaneous coronary intervention within the previous 6 weeks)
* with active inflammatory diseases, infectious diseases or known malignancy
* under treatment with corticosteroids, anti-inflammatory agents or disease modifying agents
* with known hypersensitivity-allergy to colchicine
* under chronic treatment with colchicine
* with severe renal failure (eGFR \< 35 ml/min/1.73 m2)
* with hepatic failure (Child - Pugh class B or C)

Primary outcomes:
measure: Myocardial damage marker levels
timeFrame: Days 1-2 post-CABG
Secondary outcomes:
measure: All cause mortality
timeFrame: At one and at six months after CABG
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Athens General Hospital "G. Gennimatas"
state: Attika
Study officials:
affiliation: Athens General Hospital "G. Gennimatas"
name: Spyridon Deftereos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Giannopoulos G, Angelidis C, Kouritas VK, Dedeilias P, Filippatos G, Cleman MW, Panagopoulou V, Siasos G, Tousoulis D, Lekakis J, Deftereos S. Usefulness of colchicine to reduce perioperative myocardial damage in patients who underwent on-pump coronary artery bypass grafting. Am J Cardiol. 2015 May 15;115(10):1376-81. doi: 10.1016/j.amjcard.2015.02.036. Epub 2015 Feb 18.
Clinical trial NCT02782884: A Prospective Study of Post-operative Opioid Use in General Surgery Patients
Official title: A Prospective Study of Post-operative Opioid Use in General Surgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: post-operative pain
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2016-05-25
Enrollment: 50
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: \>= 18 years of age undergoing one of 9 elective outpatient operations: partial mastectomy, partial mastectomy and sentinel node biopsy, melanoma wide excision and sentinel node excision, thyroidectomy, parathyroidectomy, open inguinal hernia repair, laparoscopic inguinal hernia repair, laparoscopic cholecystectomy OR an inpatient on the general surgery service who took at least one oral narcotic in the 24 hrs prior to discharge

Brief summary: Patients undergoing approximately 10 common outpatient general surgical operations will be given a narcotic prescription for a specified number of pills.

Inpatients who are about to be discharged after surgery or trauma will be given narcotic prescriptions for a specified number of pills. Patients will be given a patient report form which they will use to record the number of pills they take each day and their daily pain score on a scale of 0-10.


Eligibility criteria: Inclusion Criteria:

* \>= 18 years of age
* undergoing one of 9 elective outpatient operations: partial mastectomy, partial mastectomy and sentinel node biopsy, melanoma wide excision and sentinel node excision, thyroidectomy, parathyroidectomy, open inguinal hernia repair, laparoscopic inguinal hernia repair, laparoscopic cholecystectomy OR
* an inpatient on the general surgery service who took at least one oral narcotic

Exclusion Criteria:

* allergic to all narcotics
* chronic opioid use
* history of opioid or benzodiazepine abuse

Primary outcomes:
measure: number of pills to satisfy 80% of patients opioid needs
timeFrame: 1 yr
Secondary outcomes:
measure: proportion of patients requiring narcotic refills when specified number of pills is given
timeFrame: 1 year
measure: patient pain level, daily
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Richard J Barth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02940184: GLP-1 Signaling in Truncally Vagotomized Subjects
Official title: Vagal Mechanisms Mediating the Effects of Glucagon-Like Peptide 1 (GLP-1) on the Endocrine Pancreas - the Entero-endocrine Axis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physiology
Keywords: Physiology
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2016-10-20
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Investigation of the importance of vagal signaling for the glucohomeostatic effects of GLP-1. The study will include physiological studies of truncally vagotomized participants and matched controls.


Eligibility criteria: Truncally vagotomized individuals:

Inclusion Criteria:

* Normal fasting plasma glucose
* Normal haemoglobin concentration
* Cardiaresection with a pyloroplasty
* Informed consent

Exclusion Criteria:

* Diabetes mellitus
* Disposition for diabetes mellitus
* Intestinal disease (apart from cardia resection+pyloroplasty)
* Disposition of inflammatory bowel disease
* Intestinal resection (apart from cardia resection+pyloroplasty)
* Body mass index (BMI) \> 27,5 kg/m2
* Tobacco use
* Nephropathy (se-creatinine\> 130 µM and/or albuminuria)
* Liver disease (ALAT and/or ASAT \>2 × refference value)
* known heart condition
* medicinal use, that may not be paused for 12 hours
* Obstipation
* swallowing difficulties
* previous problems with intestinal tube placement
* Latex allergy
* Fructose malabsorption
* Known diseases in the pharynx
* Previous facial or cranial fractures
* Sinusitis
* Bleeding diathesis

Matched controls:

Inclusion Criteria:

* Normal fasting plasma glucose
* Normal haemoglobin concentration
* Informed consent

Exclusion Criteria:

* Cardiaresection with a pyloroplasty
* Diabetes mellitus
* Disposition for diabetes mellitus
* Intestinal disease (apart from cardia resection+pyloroplasty)
* Disposition of inflammatory bowel disease
* Intestinal resection tarmresektion (apart from cardia resection+pyloroplasty)
* Body mass index (BMI) \> 27,5 kg/m2
* Tobacco use
* Nephropathy (se-creatinine\> 130 µM and/or albuminuria)
* Liver disease (ALAT and/or ASAT \>2 × refference value)
* known heart condition
* medicinal use, that may not be paused for 12 hours
* Obstipation
* swallowing difficulties
* previous problems with intestinal tube placement
* Latex allergy
* Fructose malabsorption
* Known diseases in the pharynx
* Previous facial or cranial fractures
* Sinusitis
* Bleeding diathesis

Primary outcomes:
measure: Insulin secretion
timeFrame: up to 4 hours
Secondary outcomes:
measure: Glucagon secretion
timeFrame: 4 hours
measure: Glucose levels
timeFrame: 4 hours
measure: Pancreatic Polypeptide levels
timeFrame: 4 hours
measure: GIP secretion
timeFrame: 4 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Surgery C, Rigshospitalet
Study officials:
References:
Clinical trial NCT00047684: Brief Integrative Therapy for Post-Traumatic Stress Disorder
Official title: Development and Initial Evaluation of Brief Integrative Therapy for PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: Child Abuse, Sexual
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2002-10-16
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to refine Brief Integrative Therapy (BIT) and to evaluate its effectiveness in treating women with Post-Traumatic Stress Disorder (PTSD) following childhood sexual abuse. This study will also promote the development of skills that are necessary for increasing quality of life and improving self-esteem.

Detailed description: BIT integrates interpersonal, problem solving, affect regulation, and psychoeducational components. In this study, BIT is used to encourage women to focus on current issues and problems. The BIT therapist will help patients identify the impact of PTSD on their functioning, help them identify effective coping strategies for dealing with trauma-related distress, and encourage them to establish and maintain a certain degree of independence from the therapist.

Patients receive 15 weekly sessions of BIT. Assessments occur pre-treatment, post-treatment, and at a 3-month follow-up, and include self-report measures, clinician administered PTSD scale questions, interviews, and evaluations of lifetime stressors.

Eligibility criteria: Inclusion Criteria:

* Post-Traumatic Stress Disorder (PTSD) diagnosis
* Childhood sexual abuse, defined as any sexual contact before the age of 16 with someone 5 or more years older
* At least 1 clear, detailed memory of sexual abuse

Exclusion criteria:

* Substance abuse or dependence
* Psychotic disorder, bipolar disorder, or dissociative disorder
* 2 or more suicidal or parasuicidal acts in the past year
* Domestic violence involvement
* Pregnancy or attempting to become pregnant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: White River Junction
country: United States
facility: National Center for PTSD
state: Vermont
Study officials:
References: