louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00059267: Prevention of Recurrent Hepatitis B After Liver Transplantation
Official title: Prevention of Recurrent Hepatitis B After Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Cirrhosis
Acute Liver Failure
Hepatocellular Carcinoma
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: University of Michigan
First posted: 2003-04-23
Enrollment: 317
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients listed for liver or combined liver-kidney transplantation for hepatitis B including hepatitis B cirrhosis, hepatitis B liver cancer and fulminant hepatitis B.

Brief summary: Hepatitis B accounts for approximately 5000 deaths per year in the United States. Liver transplantation offers the only hope for patients who develop end-stage liver disease. Early results of liver transplantation for hepatitis B were poor with recurrence rate of 80% and 1-year survival of only 50%. Recent studies found that preventive therapy using hepatitis B immune globulin (HBIG) or antiviral medications such as lamivudine can reduce the recurrence rate to roughly 30% with accompanying improvement in survival. However, HBIG when given as intravenous infusion in high doses is very expensive, while long-term use of lamivudine is associated with drug resistance. Some studies found that preventive therapy using both HBIG and lamivudine may decrease recurrence rate to less than 10% but the dose and duration of HBIG needed when used in combination with lamivudine is not clear. Adefovir, a new antiviral medication, is effective against lamivudine resistant hepatitis B but its role in liver transplantation is uncertain because of the risk of kidney damage. Many studies showed that the risk of recurrent hepatitis B is related to the viral load before transplant. Thus, it may be possible to tailor the preventive therapy according to the risk. The aim of this study is to establish the most cost-effective preventive therapy for recurrent hepatitis B after liver transplantation.


Eligibility criteria: Inclusion criteria: adult patients listed for liver or liver-kidney transplant for hepatitis B.

Exclusion criteria: patients with contraindications to use of prophylactic antiviral therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Anna S Lok, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Degertekin B, Han SH, Keeffe EB, Schiff ER, Luketic VA, Brown RS Jr, Emre S, Soldevila-Pico C, Reddy KR, Ishitani MB, Tran TT, Pruett TL, Lok AS; NIH HBV-OLT Study Group. Impact of virologic breakthrough and HBIG regimen on hepatitis B recurrence after liver transplantation. Am J Transplant. 2010 Aug;10(8):1823-33. doi: 10.1111/j.1600-6143.2010.03046.x. Epub 2010 Mar 23.
Clinical trial NCT00956267: Letrozole or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome.
Official title: Letrozole Versus Laparoscopic Ovarian Diathermy for Ovulation Induction in Clomiphene-resistant Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic ovary syndrome
clomiphene resistance
letrozole
Laparoscopic ovarian diathermy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2009-08-11
Enrollment: 260
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare and determine the efficacy of letrozole administration to that of laparoscopic ovarian diathermy (LOD) in infertile women with Polycystic ovary syndrome(PCOS)not responding to treatment with Clomiphene alone.

Detailed description: In the letrozole group, withdrawal bleeding was achieved using 10 mg of dydrogesterone tablets for 10 days before stimulation, then 2.5 mg of letrozole oral tablets (Femara; Novartis Pharma Services, Switzerland) daily from day 3 of the menses for 5 days up to six cycles. All patients in the control group underwent laparoscopic ovarian diathermy, then followed up for 6 months.

Eligibility criteria: Inclusion Criteria:

* CC resistant PCOS

Exclusion Criteria:

* Congenital adrenal hyperplasia
* Cushing syndrome
* Androgen secreting tumors

Primary outcomes:
measure: occurrence of ovulation and midcycle endometrial thickness (mm).
Secondary outcomes:
measure: occurrence of pregnancy, miscarriage, multiple pregnancy and live birth rates.
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospitals,OB/GYN department
state: Dakahlia Governorate
Study officials:
affiliation: Mansoura University Hospital
name: Hatem Abu Hashim, MD. MRCOG
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University Hospital
name: Abdel Maged Mashaly, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University Hospital
name: Ahmed Badawy, MD.PhD.
role: STUDY_CHAIR
References:
citation: Holzer H, Casper R, Tulandi T. A new era in ovulation induction. Fertil Steril. 2006 Feb;85(2):277-84. doi: 10.1016/j.fertnstert.2005.05.078.
citation: Bayram N, van Wely M, Kaaijk EM, Bossuyt PM, van der Veen F. Using an electrocautery strategy or recombinant follicle stimulating hormone to induce ovulation in polycystic ovary syndrome: randomised controlled trial. BMJ. 2004 Jan 24;328(7433):192. doi: 10.1136/bmj.328.7433.192.
citation: Farquhar C, Lilford RJ, Marjoribanks J, Vandekerckhove P. Laparoscopic 'drilling' by diathermy or laser for ovulation induction in anovulatory polycystic ovary syndrome. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD001122. doi: 10.1002/14651858.CD001122.pub3.
Clinical trial NCT03462667: Intensive Preoperative Ostomy Education for the Radical Cystectomy Patient
Official title: Intensive Preoperative Ostomy Education for the Radical Cystectomy Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stoma Ileostomy
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2018-03-12
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to learn if the stoma boot camp is a good and effective way to help people adapt to life with a stoma after surgery.

Detailed description: Bladder cancer is the fifth most common cancer in the USA. The primary treatment for invasive bladder cancer is a radical cystectomy (RC) with a urinary diversion. Patients that have this procedure must deal with a stoma that requires daily care and manual skills. A stoma is an artificial opening that allows urine to pass from the ureters outside the body. Having a surgery that results in a stoma can dramatically change a person's life.

This study is being done to test a new education session called the stoma boot camp. The session was created to help people deal with changes in their post-surgery life and living with a stoma.

The session requires a one time visit to the study site and lasts about two hours. Participants can bring a support person to the boot camp if they choose. During the two hour session, nurses will provide teaching, counseling, and hands on practice with an artificial stoma.

Eligibility criteria: Inclusion Criteria:

* Patients must be presumed to undergo a radical cystectomy with ileal conduit diversion
* Diagnosis of bladder cancer

Exclusion Criteria:

* Patients undergoing a radical cystectomy with ileal conduit for any reason other than bladder cancer will not be allowed to participate

Primary outcomes:
measure: Ostomy adjustment scale
timeFrame: Change from Baseline to 30 Days After Date of Surgery
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Date of Admission to Date of Discharge, up to 7 days
measure: Count of un-planned stoma-related interventions in community after discharge
timeFrame: 30 Days After Date of Surgery
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Moben Mirza, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05330767: DermaClose DUKE Fasciotomy and Wound Study
Official title: DermaClose Continuous External Tissue Expander for the Management of Four-Compartment Fasciotomy and Full-Thickness Wounds.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Wound of Skin
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
Collaborators: name: Duke University
First posted: 2022-04-15
Enrollment: 7
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: The study population will include patients who have acute full thickness wound(s) of the skin (including four-compartment leg fasciotomy) and in whom DermaClose and/or DermaClose XL, or conventional dressing is used.

Brief summary: To evaluate the clinical performance of DermaClose and DermaClose XL Continuous External Tissue Expander (CETE) devices to reduce wound size and/or assist with closure in acute full thickness wounds of the skin and assess the need for skin grafting for patients undergoing a four-compartment leg fasciotomy.


Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years of age at the time of consent.
* Patient with a full thickness acute wound(s) of the skin:

  1. On either the upper or lower extremity (including four-compartment leg fasciotomy), in whom DermaClose and/or DermaClose XL is applied during surgery, OR
  2. Undergoing a four-compartment leg fasciotomy requiring conventional wound dressing.
* Patient has signed a written informed consent form (ICF) per 21 Code of Federal Regulations (CFR) Part 50.55(e).

Exclusion Criteria:

* Patient in whom the product was used off-label (except for patients who have the device on for longer than 14 days)
* Patient with wound(s) that exhibit any of the following:

  * Ischemic tissue,
  * Infected tissue,
  * Acute burned tissue,
  * Fragile tissue at the edges of the wound(s).
* Patient, who in surgeon's opinion, does not fit the criteria for this study.

Primary outcomes:
measure: Proportion of investigator-confirmed wound size reduction or assistance with closure of acute full thickness wounds
timeFrame: Up to 14 Days (or longer if deemed necessary by surgeon)
Secondary outcomes:
measure: Mean percentage of wound size reduction
timeFrame: Up to 14 Days (or longer if deemed necessary by surgeon)
measure: Median number of days until wound closure
timeFrame: Up to 14 Days (or longer if deemed necessary by surgeon)
measure: Proportion of wounds treated with subsequent reconstruction with a skin graft after fasciotomy
timeFrame: Up to 60 Days
measure: Proportion of wounds requiring subsequent surgical procedure(s) for wound closure
timeFrame: Up to 60 Days
measure: Number of days until hospital discharge
timeFrame: Up tp 60 Days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References:
Clinical trial NCT02214667: Treating Co-Occurring Substance Use and Mental Disorders Among Jail Inmates
Official title: Treating Co-Occurring Substance Use and Mental Disorders Among Jail Inmates
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Co-occurring Mental and Substance Use Disorders
Crime
Criminogenic Thinking
Implementation
Adaptation
Keywords: Jail
co-occurring disorders
implementation
acceptability
feasibility
fidelity
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: Boston University
First posted: 2014-08-12
Enrollment: 8
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: Treatment adaptation and implementation study for adult jail inmates with co-occurring substance use disorders.

Detailed description: We will adapt dual-diagnosis motivational interviewing and integrated group therapy for jail inmates with co-occurring substance use and mental health disorders and to evaluate the feasibility of implementing the adapted interventions and associated research and communication protocols.

Eligibility criteria: Inclusion Criteria:

* (1) drug or alcohol abuse or dependence and SMI (major depressive disorder; depressive disorder not otherwise specified \[NOS\]; bipolar disorder I, II, or NOS; schizophrenia spectrum disorder; schizoaffective disorder; schizophreniform disorder; brief psychotic disorder; delusional disorder; or psychotic disorder NOS);
* (2) resident of Wake County and detained in The Jail;
* (3) \>18 years of age; (4) able to speak/read English; and (5) able to provide informed consent.

Exclusion Criteria:

-

Primary outcomes:
measure: Acceptability
timeFrame: Study months 21 through 34
Secondary outcomes:
measure: Feasibility of Adapted Interventions
timeFrame: Study months 21 through 34
measure: Fidelity
timeFrame: Study months 21 through 34
measure: Substance use
timeFrame: Study months 20 through 30
measure: Psychiatric symptoms
timeFrame: Study months 20 through 30
measure: Health status
timeFrame: Study months 20 through 30
measure: Service use
timeFrame: Study months 20 through 30
measure: Externalizing behaviors
timeFrame: Study months 20 through 30
measure: Quality of life measure
timeFrame: Study months 20 through 30
measure: Arrest
timeFrame: Study months 20 through 30
measure: Treatment preferences
timeFrame: Study months 20 through 30
Other outcomes:
Locations:
city: Research Triangle Park
country: United States
facility: RTI International
state: North Carolina
Study officials:
affiliation: RTI International
name: Richard A Van Dorn, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Dorn RA, Desmarais SL, Rade CB, Burris EN, Cuddeback GS, Johnson KL, Tueller SJ, Comfort ML, Mueser KT. Jail-to-community treatment continuum for adults with co-occurring substance use and mental disorders: study protocol for a pilot randomized controlled trial. Trials. 2017 Aug 4;18(1):365. doi: 10.1186/s13063-017-2088-z.
Clinical trial NCT00964067: Aerobic Interval Training in Cardiac Rehabilitation
Official title: Effect of High Intensity Aerobic Interval Training in Cardiac Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Coronary Artery Disease
Keywords: rehabilitation outcome
cardiac patients
exercise intensity
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2009-08-24
Enrollment: 90
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: The purpose of the study is to compare home-based aerobic interval training with supervised interval training performed in groups or on a treadmill at the hospital.

Detailed description: Cardiac rehabilitation is usually first offered in hospitals, but there are several studies that show that home-based rehabilitation is equally efficient. How this comes out when exercise is organized as aerobic interval training is not known.

Eligibility criteria: Inclusion Criteria:

* coronary artery disease
* age over 18
* referred to cardiac rehabilitation
* exercise tolerance demonstrated

Exclusion Criteria:

* severe arrhythmia
* heart failure
* drug abuse
* pregnancy

Primary outcomes:
measure: VO2peak
timeFrame: baseline, after 12 weeks and after 1 year
Secondary outcomes:
measure: quality of life
timeFrame: baseline, 12 weeks and 1 year
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St.Olavs University Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Asbjørn Støylen, PhD
role: STUDY_DIRECTOR
References:
citation: Aamot IL, Karlsen T, Dalen H, Stoylen A. Long-term Exercise Adherence After High-intensity Interval Training in Cardiac Rehabilitation: A Randomized Study. Physiother Res Int. 2016 Mar;21(1):54-64. doi: 10.1002/pri.1619. Epub 2015 Feb 16.
citation: Aamot IL, Forbord SH, Gustad K, Lockra V, Stensen A, Berg AT, Dalen H, Karlsen T, Stoylen A. Home-based versus hospital-based high-intensity interval training in cardiac rehabilitation: a randomized study. Eur J Prev Cardiol. 2014 Sep;21(9):1070-8. doi: 10.1177/2047487313488299. Epub 2013 Apr 23.
Clinical trial NCT02033967: Vasodilator-induced Hypovolemia in Living Liver Donors
Official title: Vasodilator-induced Hypovolemia in Living Liver Donors: Central Venous Pressure-guided vs Stroke Volume Variation-guided Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CVP and SVV During Living Donor Hepatectomy
Surgical Field Grade (Condition of Surgical Field; Bleeding, Tension of the IVC)
Keywords: liver donor
hepatectomy
vasodilator
central venous pressure
stroke volume variation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-01-13
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Induced hypovolemia is known to improve surgical field during living donor hepatectomy. This procedure is conventionally guided by monitoring the central venous pressure (CVP). Stroke volume variation (SVV) is a novel method to substitute with CVP to monitor cardiac preload. The investigators try to evaluate the relationship between CVP and SVV during CVP-guided vasodilator induced hypovolemia (validation study). Then, feasibility of vasodilator induced hypovolemia using the SVV calculated from the validation study will be tested (feasibility study).

Detailed description: This is a 2-phases study.

first phase validation study : Evaluation of the relationship between CVP and SVV during CVP-guided vasodilator induced hypovolemia

second phase feasibility study

: Comparison of the surgical field grade between validation study group(CVP guided group) and feasibility study group(SVV guided group)

Eligibility criteria: Inclusion Criteria:

* adult (20-60 yr)
* elective living liver donors

Exclusion Criteria:

* not obtained informed consent

Primary outcomes:
measure: target value of SVV
timeFrame: during living donor hepatectomy
Secondary outcomes:
measure: surgical field
timeFrame: during living donor hepatectomy
measure: use of inotropics
timeFrame: during living donor hepatectomy
measure: estimated blood loss
timeFrame: during living donor hepatectomy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national University Hospital
Study officials:
References:
citation: Lee J, Kim WH, Ryu HG, Lee HC, Chung EJ, Yang SM, Jung CW. Stroke Volume Variation-Guided Versus Central Venous Pressure-Guided Low Central Venous Pressure With Milrinone During Living Donor Hepatectomy: A Randomized Double-Blinded Clinical Trial. Anesth Analg. 2017 Aug;125(2):423-430. doi: 10.1213/ANE.0000000000002197.
Clinical trial NCT06433167: Investigation of Gait Pattern in Idiopathic Scoliosis
Official title: Investigation of Gait Pattern in Idiopathic Scoliosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Idiopathic Scoliosis
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include 30 scoliosis patients who visited the Department of Orthopedics and Traumatology at Gazi University Hospital and were diagnosed with idiopathic scoliosis by a specialist physician and 30 healty control without scoliosis.

Brief summary: Scoliosis is a condition characterized by an abnormal curvature of the spine, which can affect an individual's gait. Scoliosis can alter body balance and weight distribution. Pedobarographic analysis identifies imbalances and abnormal pressure points by measuring the distribution of pressure applied to the sole of the foot. This examination helps detect abnormalities in the gait mechanics of individuals with scoliosis. Gait analysis can identify long-term foot and leg problems caused by scoliosis at an early stage, allowing for early interventions to prevent more serious issues.

The aim of this study is to analyze gait in individuals with idiopathic scoliosis and compare it with that of healthy individuals. The study will include 30 scoliosis patients who visited the Department of Orthopedics and Traumatology at Gazi University Hospital and were diagnosed with idiopathic scoliosis by a specialist physician. The gait patterns of the patients will be evaluated using pedobarography. Information about the type and degree of scoliosis will be obtained from hospital records. The results of this study may provide an objective and detailed evaluation of gait and pressure distribution disorders in individuals with scoliosis and may contribute to more effective treatment plans.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic scoliosis by an orthopedist
* The Cobb angle measured on the standard scoliosis radiograph should fall within the range of 10°-45°.

Exclusion Criteria:

* Presence of any orthopedic or neurological disease affecting trunk and extremity mobility, excluding scoliosis.
* History of previous spine or orthopedic surgery.

Primary outcomes:
measure: Pedobarography
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Hospital
Study officials:
affiliation: Gazi University
name: İnci H Ayas, Msc
role: STUDY_DIRECTOR
affiliation: Gazi University
name: Furkan Aral, MD
role: STUDY_CHAIR
affiliation: Gazi University
name: Burak Oklaz, MD
role: STUDY_CHAIR
affiliation: Gazi University
name: Ulunay Kanatlı, MD
role: PRINCIPAL_INVESTIGATOR
References: