louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01742234: RELIVE Informed Consent Study
Official title: Renal and Lung Living Donors Evaluation (RELIVE) Informed Consent Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Living Donors
Tissue Donors
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2012-12-05
Enrollment: 624
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: People who will be donating at kidney at the University of Minnesota, Mayo Clinic, or University of Alabama or people who will be donating a lung at University of Washington Medical School or the University of Southern California

Brief summary: An organ transplant is frequently the best option and, in some cases, the only option to save the lives of transplant recipients. Receiving an organ from a living donor eliminates the need to wait for a deceased donor, an option that many transplant recipients do not survive. However, donating an organ presents health concerns to the donor as well. This study will use surveys to evaluate the understanding of risk and psychological pressure that living organ donors felt when making the decision to donate. It will also compare participants' answers across geographic, racial and socio-economic backgrounds.


Eligibility criteria: Inclusion Criteria:

* Living donor of a kidney or lung

Exclusion Criteria:

* Unable to give informed consent

Primary outcomes:
measure: Questionnaire Score 1
timeFrame: Change from 1 week prior to donation and 3 months after donation
measure: Questionnaire Score 2
timeFrame: Change from 1 week prior to donation and 3 months after donation
measure: Questionnaire Score 3
timeFrame: Change from 1 week prior to donation and 3 months after donation
Secondary outcomes:
measure: Questionnaire Score Secondary Endpoint 1
timeFrame: Change from 1 week prior to donation and 3 months after donation
measure: Questionnaire Score Secondary Endpoint 2
timeFrame: Change from 1 week prior to donation and 3 months after donation
measure: Questionnaire Score Secondary Endpoint 3
timeFrame: Change from 1 week prior to donation and 3 months after donation
measure: Questionnaire Score Secondary Endpoint 4
timeFrame: Change from 1 week prior to donation and 3 months after donation
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota, Center for Bioethics
name: Maryam Valapour, MD
role: STUDY_CHAIR
References:
citation: Valapour M, Kahn JP, Bailey RF, Matas AJ. Assessing elements of informed consent among living donors. Clin Transplant. 2011 Mar-Apr;25(2):185-90. doi: 10.1111/j.1399-0012.2010.01374.x. Epub 2010 Dec 16.
Clinical trial NCT04703634: The Effect of Ultrasound-guided Erector Spinae Block on Postoperative in Patients Undergoing Nephrectomy.
Official title: The Effect of Ultrasound-guided Erector Spinae Block on Postoperative Analgesic Consumption in Patients Undergoing Nephrectomy. Prospective Randomized Single-center Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nephrectomy
Keywords: erector spinae block
nephrectomy
ultrasound
Lead sponsor: Namik Kemal University
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: It is a single centre, randomized, prospective method comparison study.
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the postoperative effect of erector spinae block in patients undergoing nephrectomy that causes both visceral and somatic pain.

Detailed description: After being informed and potential risks about the study, all patients have given written consent will undergo 24 hours screening for the analgesic effect of erector spinae block after nephrectomy. Patients meeting the criteria were randomly selected in double-blind manner 1:1 ratio to erector spiane block or not.

Eligibility criteria: Inclusion Criteria:

1. To undergo partial or total nephrectomy surgery
2. To be in ASA I-II classification
3. To be between the ages of 18-65.
4. Not having problems that prevent erector spinae block application such as local anesthetic drug allergy, infection at the injection site, and structural anomaly.
5. Being in good mental and psychological health
6. To accept to participate in the study.

Exclusion Criteria:

1. Being in ASA III or IV class with a high risk of anesthesia
2. Being outside the age range of 18-65
3. Having problems such as local anesthetic drug allergy, infection at the injection site, and structural anomaly prevents block application.
4. Not being mentally and psychologically healthy
5. Those who are allergic to the active substance, patients using antiepileptic drugs
6. Those with severe hepatic and renal failure
7. Those who have long-term use of nonsteroidal anti-inflammatory and opioid analgesic,
8. Those with diabetes and other neuropathic diseases
9. Patients who cannot use patient-controlled analgesia (PCA) device

Primary outcomes:
measure: Numerical Rating Scale (NRS)
timeFrame: 24 hours
Secondary outcomes:
measure: Recovery analgesia
timeFrame: 24 hours
measure: postoperative nausea and vomiting
timeFrame: 24 hours
Other outcomes:
Locations:
city: Tekirdağ
country: Turkey
facility: Namık Kemal University
state: Süleymanpaşa
Study officials:
affiliation: Namık Kemal University Medicine Faculty
name: Ayhan ŞAHİN
role: STUDY_CHAIR
References:
Clinical trial NCT03008434: Traumatic Brain Injury and Yoga
Official title: Traumatic Brain Injury and Yoga
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Traumatic Brain Injury
Keywords: yoga
Traumatic Brain Injury
Lead sponsor: Colorado State University
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This long-term goal of this project was to advance best practices in occupational therapy in conjunction with yoga. To address the long-term goal, this research team developed a pilot yoga intervention. The intervention was designed to focus on balance, balance confidence, body responsiveness, pain, physical ability and quality of life. Assessments were then chosen to address these areas pre and post yoga intervention. A manual and protocol were developed for the intervention and then the intervention was implemented with a group of individuals with chronic traumatic brain injury.

Detailed description: This was an 8-week yoga intervention, focused on demonstrating the preliminary feasibility and efficacy of yoga for individuals with chronic traumatic brain injury. The study was a mixed-methods longitudinal study. Assessments were conducted 8 weeks prior to the yoga intervention and then just following the 8 week yoga intervention. The objectives of this feasibility and efficacy study was to 1) further develop, standardize, and manualize the yoga for the traumatic brain injury intervention and 2) assess change in balance, balance confidence, body responsiveness, pain, physical ability, and quality of life.

Eligibility criteria: Inclusion Criteria:

* chronic TBI (\>6 months)
* greater than or equal to 18 years of age
* no consistent practice of yoga in the last year

Exclusion Criteria:

* inability to provide informed consent
* less than 18 years of age
* self-report of exercise restriction
* consistent yoga practice within the last year
* inability to attend sessions based on transportation restrictions

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Activities Balance Confidence Scale
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
affiliation: Colorado State University
name: Arlene Schmid, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00881634: To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fed Conditions
Official title: A Single-Dose Comparative Bioavailability Study of Two Formulations of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergies
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-04-15
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 53
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg ER tablets under fed conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pharma Medica Research, Inc.
name: Xueyu (Eric) Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05971134: Acupressure and Fistula Needle Insert Pain Management
Official title: The Effect of Acupressure Applied to Different Fistula Area on Fistula Needle Insert Pain: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease Stage 5 (Disorder)
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 131
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Introduction: This study was conducted to determine the effectiveness of acupressure application on Hegu (LI4) point on the severity of acute pain caused by fistula needle in patients with brescia-cimino, snuff-box and antecubital fistula.

Methods: This study was randomized control study which was conducted with 66 intervention and 65 control participants. The participants in the intervention group were divided into 3 groups according to the fistula area. Data were collected using Descriptive Information Form and pain scale.

Detailed description: This study is determined that finger acupuncture at L14 point reduces the severity of pain felt by the patient during fistula needle insertion. Acute pain during puncture of arteriovenous fistula is a common problem in hemodialysis patients. Moreover, patients experience this acute pain three times a week. Accordingly, acupressure applied to the L4 acupuncture point can be considered as an effective, simple and low-cost non-pharmacological method to reduce acute pain during needle insertion in patients. Since this application is non-invasive and does not carry the risk of complications, it can be taught to patients and/or nurses to contribute to the management of acute pain. In addition, in this article, we examined the effect of acupressure applied only to the LI4 acupuncture point on pain intensity during fistula needle insertion, therefore, we suggest designing different studies with different acupuncture points (effective in reducing pain).

Eligibility criteria: Inclusion Criteria

18 years or older have brescia-cimino, snuff-box or antecubital fistula speak Turkish have hemodialysis(HD) treatment three times a week have not used analgesics in the last 6 hours had no pain who volunteered to participate in the study.

Exclusion Criteria With aneurysmatic fistula had soft tissue damage infection in extremities has coagulations and bleeding problems.

Primary outcomes:
measure: Numeric Rating Scale was used to determine the severity of acute pain experienced by patients during fistula needle insertion.
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University
state: Türkiye
Study officials:
affiliation: Baskent University
name: Assistant prof. GÜLAY TURGAY
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00279734: Vaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers
Official title: An Exploratory Study to Evaluate the Effect of Abatacept (BMS-188667) on the Antibody Response Following Tetanus Toxoid and 23-Valent Pneumococcal Vaccinations in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-01-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to assess the ability of healthy subjects to build anitbodies to tetanus and pneumococcal vaccines after receiving a single intravenous dose of Abatacept, a drug which is being developed for the treatment of Rheumatoid Arthritis and which can affect the immune system.


Eligibility criteria: Inclusion Criteria:

* Healthy Subjects
* Body Weight between 60 and 100 kg.
* Males and Females must be using adequate contraceptive methods during study and for 10 weeks after dose of study mediciation.

Exclusion Criteria:

* Females who are prgnant or breastfeeding
* History of autoimmune disorder, immunodeficiency, or infection within past 3 months.
* Active TB requiring treatment within the previous 3 years.
* Positive breast cancer screen, PPD test.
* Vaccination with tetanus or pneumococcal vaccine within 5 years.
* Vaccination with any live vaccine within 4 weeks.
* History of drug or alcohol abuse.
* Any significant allergy.

Primary outcomes:
measure: Assess effect of single 750mg dose of Abatacept on antibody response to tetanus toxioid and 23-valent pneumococcal vaccines.
Secondary outcomes:
measure: Assess safety and tolerability of Abatacept given in conjunction with tetanus toxoid and 23-valent pneumococcal vaccines.
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Qutintiles Phase I Services
state: Kansas
city: Baltimore
country: United States
facility: Parexel International Corp
state: Maryland
city: Austin
country: United States
facility: PPD Development
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Tay L, Leon F, Vratsanos G, Raymond R, Corbo M. Vaccination response to tetanus toxoid and 23-valent pneumococcal vaccines following administration of a single dose of abatacept: a randomized, open-label, parallel group study in healthy subjects. Arthritis Res Ther. 2007;9(2):R38. doi: 10.1186/ar2174.
Clinical trial NCT03094234: 8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) Plus Propranolol for Prevention of Variceal Rebleeding in Patients With Child A Cirrhosis
Official title: 8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) Plus Propranolol for Prevention of Variceal Rebleeding in Patients With Child A Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Portal Hypertension
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 72
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: The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm expanded polytetrafluoroethylene(ePTFE)-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding in patients with Child A cirrhosis

Detailed description: For the prevention of recurrent esophageal variceal bleeding, previous clinical studies and meta-analysis show that patients treated with transjugular intrahepatic portosystemic shunt (TIPS) have lower rebleeding rates compared with endoscopic therapy. However, TIPS is associated with higher rates of portosystemic encephalopathy and does not show survival benefit. TIPS with a small-diameter may achieve sufficient portal decompression and reduce the incidence of hepatic encephalopathy. The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm ePTFE-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.

Eligibility criteria: Inclusion Criteria:

Cirrhosis Patients who had bled from esophageal varices (≥5days and ≤28days) Child-Pugh A -

Exclusion Criteria:

The presence of gastric varices Non-cirrhotic portal hypertension Portal vein thrombosis The history of hepatic encephalopathy Total bilirubin ≥51.3 umol/L Previous treatment of TIPS or surgery Proven malignancy including hepatocellular carcinoma Contraindications to TIPS、EVL or propranolol End-stage renal disease under renal replacement therapy; Cardiorespiratory failure Pregnancy or patients not giving informed consent for endoscopic procedure

-

Primary outcomes:
measure: Variceal rebleeding rate
timeFrame: 3 years
Secondary outcomes:
measure: Hepatic encephalopathy rate
timeFrame: 3 years
measure: TIPS dysfunction rate
timeFrame: 3 years
measure: The incidence of complications
timeFrame: 3 years
measure: Mortality rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West china hospital
Study officials:
References:
citation: Simonetti RG, Perricone G, Robbins HL, Battula NR, Weickert MO, Sutton R, Khan S. Portosystemic shunts versus endoscopic intervention with or without medical treatment for prevention of rebleeding in people with cirrhosis. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD000553. doi: 10.1002/14651858.CD000553.pub3.
Clinical trial NCT02543034: Compare of Petrolatum Gauze, Allevyn, and New Dressing, Betafoam® in the Management of Split-Thickness Skin Graft Donor Site
Official title: Randomized, Controlled, Phase IV Study of Petrolatum Gauze, Allevyn, and New Dressing, Betafoam® in the Management of Split-Thickness Skin Graft Donor Site
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Graft
Lead sponsor: Mundipharma Korea Ltd
Sponsor class: INDUSTRY
First posted: 2015-09-07
Enrollment: 105
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a randomized, controlled, multi-centre, open-label, phase IV study.

Total 81 patients will be enrolled in this study. Patients will be randomly assigned to Betafoam®, petrolatum gauze or Allevyn for donor site wounds after skin graft operation.


Eligibility criteria: Inclusion Criteria:

1. Patients who is same as or more than 19 years old
2. Patients who will receive elective skin harvest operation
3. Patients who is in lateral thigh or buttock with donor site area from 50 to 150 cm2
4. Female patients who use method of contraception for the study
5. Patients who voluntarily sign the informed consent

Exclusion Criteria:

1. Patients who are pregnant
2. Patients who are known to have allergy to the dressing product including PVPI
3. Known hyperthyroidism or other thyroid dysfunction such as nodular thyroid goiter, endemic goiter and Hashimoto's thyroiditis or patients who receive radioiodine therapy
4. Co-morbidities which may adversely affect wound healing for example a patient with uncontrolled diabetes (HbA1c \> 8%), chronic renal failure, autoimmune disease, or immunocompromised patient
5. Patients who receive anticoagulants, steroids or immunosuppressants
6. Patients who have signs and symptoms of infection on enrollment and adversely affect wound healing
7. Patients who have skin lesion such as Herpes zoster on donor site
8. Burn of \>20% total body surface area
9. If the donor site had been harvested on a previous occasion
10. Patients who is limited cognitive ability
11. Patients who are participating in or will plan to participate in other clinical trials
12. Other various conditions that the investigators judge inappropriate for enrolment

Primary outcomes:
measure: Efficacy as measured by speed of wound healing
timeFrame: 6 months
Secondary outcomes:
measure: Efficacy as measured by adverse event collection
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital, The Catholic University of Korea
name: Jongwon Lee, Dr.
role: PRINCIPAL_INVESTIGATOR
References: