louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01713452: A Randomized Trial of Ostomy Closure Techniques
Official title: A Randomized Trial of Ostomy Closure Techniques: An Outcomes Evaluation of Primary Closure Versus Pursestring Closure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Infection
Keywords: Surgical Stomas
ileostomy
surgical site infection
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Vaudois
First posted: 2012-10-24
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Stoma closure has been associated with a high rate of surgical site infection (SSI). The rate for SSI following stoma closure has been noted to be 7-41%; a rate that is higher than expected for a clean-contaminated operative classification. The ideal stoma site closure technique is still debated in the current literature. The aim of this study was to compare the rate of SSI following two different stoma closure techniques, primary closure versus a skin approximating purse string closure, in a multi-center randomized controlled trial. The investigators hypothesize that purse string closure technique will have a lower rate of SSI than primary closure technique.

Detailed description: The investigators will randomize ileostomy takedown patients to either a primary closure or purse string closure technique intraoperatively. Surgeons at both the University of Minnesota and the CHUV hospital in Switzerland will participate in the this study.

Eligibility criteria: Inclusion Criteria:

Subjects eligible are those with either a colostomy or ileostomy (end or loop) who are deemed by their surgeon to be appropriate candidates for ostomy closure. There will be no limitations based upon initial indication for formation of the ostomy. Indications for initial ostomy formation for fecal diversion can include: infection (e.g. diverticulitis) and protection of an anastomosis. (following resection for inflammatory bowel disease, benign diseases, or cancer)

Exclusion Criteria:

Subjects will be excluded from the study if:

1. The stoma site is left open to heal by secondary intention due to gross contamination (surgeon discretion)
2. The stoma site is re-used (i.e. the same stoma site used for the formation of a new ostomy)
3. A new stoma is created at a different site.

Primary outcomes:
measure: surgical site infection
timeFrame: 30 days postoperatively
Secondary outcomes:
measure: delayed wound healing
timeFrame: 30 days postoperatively
measure: patient satisfaction
timeFrame: 30 days postoperatively
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
citation: Lee JT, Marquez TT, Clerc D, Gie O, Demartines N, Madoff RD, Rothenberger DA, Christoforidis D. Pursestring closure of the stoma site leads to fewer wound infections: results from a multicenter randomized controlled trial. Dis Colon Rectum. 2014 Nov;57(11):1282-9. doi: 10.1097/DCR.0000000000000209.
Clinical trial NCT03031717: Clinical Course of Cirrhotic Patients With Portal Vein Thrombosis Treated With TIPS
Official title: Follow-up and Survival of Cirrhotic and Non Cirrhotic Patients With Portal Vein Thrombosis Treated With Transjugular Intrahepatic Portosystemic Shunt
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Portal Vein Thrombosis
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with portal vein thrombosis and with or without liver cirrhosis

Brief summary: Portal vein thrombosis (PVT) is defined as an obstruction of the portal vein. The prevalence of PVT is 10-25% and incidence is about 16% in cirrhotic patients. PVT leads to increased intrahepatic resistance, decreased portal velocities, splanchnic vasodilatation, and stagnant flow.

Portal vein recanalization (PVR) with transjugular intrahepatic portosystemic shunt (TIPS) is aimed at restoring main portal vein (PV) flow in chronic PVT. In this study, we will review the safety and outcomes of this approach.

Detailed description: Portal vein thrombosis (PVT) is a fairly common complication of liver cirrhosis. Importantly, occlusive PVT might influence the prognosis of patients with cirrhosis. Transjugular intrahepatic portosystemic shunt (TIPS) has been reported to be an effective treatment of PVT in cirrhosis, with the advantage of avoiding the risk of bleeding linked to anticoagulation. In this study, we will evaluate the outcome of TIPS for PVT in patients with and without cirrhosis and determinate survival.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Liver cirrosis or non-cirrhotic patients
* Portal vein thrombosis (degree of vessel obstruction \> 50%)

Exclusion Criteria:

* Active variceal bleeding
* Prior history of TIPS placement or shunt surgery
* Concomitant renal insufficiency
* Severe cardiopulmonary diseases
* Uncontrolled sepsis Serious medical conditions which may reduce the life expectancy
* Contraindications for TIPS

Primary outcomes:
measure: Outcome of TIPS for PVT in patients with and without cirrhosis
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubiran
name: Aldo Torre Delgadillo
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
name: Aldo Torre Delgadillo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04455217: Long--term Outcome Analysis of Fracture--related Infections
Official title: Long--term Outcome Analysis of Fracture--related Infections (Re_FRI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fracture-associated Infection (FAI)
Keywords: prosthesis infection
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with FAI attending the University Hospital Basel from January 2000 until December 2019

Brief summary: This retrospective analysis of medical records is to identify risk factors for treatment failures in fracture-associated infections (FAI) at the University Hospital Basel.


Eligibility criteria: Inclusion Criteria:

* Patients with FAI

Exclusion Criteria:

* documented denial of consent

Primary outcomes:
measure: number of flap failures at discharge from hospital
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Klinik für Plastische, Rekonstruktive, Ästhetische und Handchirurgie
Study officials:
affiliation: Klinik für Plastische, Rekonstruktive, Ästhetische und Handchirurgie; University Hospital Basel
name: Dirk Johannes Schaefer, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morgenstern M, Erichsen C, Militz M, Xie Z, Peng J, Stannard J, Metsemakers WJ, Schaefer D, Alt V, Soballe K, Nerlich M, Buckley RE, Blauth M, Suk M, Leung F, Barla JD, Yukata K, Qing B, Kates SL. The AO trauma CPP bone infection registry: Epidemiology and outcomes of Staphylococcus aureus bone infection. J Orthop Res. 2021 Jan;39(1):136-146. doi: 10.1002/jor.24804. Epub 2020 Jul 27.
Clinical trial NCT06874517: Second Toe Length and Hallux Valgus: Greek vs. Egyptian Foot
Official title: Greek vs. Egyptian Foot: The Impact of Second Toe Length on Hallux Valgus Development
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hallux Valgus
Lead sponsor: Beylikduzu State Hospital
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of 150 patients aged 60-80 years who have existing foot radiographs suitable for measurement.

Brief summary: A total of 150 patients aged 60-80 years with existing foot radiographs will be included in the study. Radiographic evaluations will include measurements of the hallux valgus angle, first intermetatarsal angle, and the metatarsal and phalanx lengths of the first and second toes. The ratio of the second toe phalanx length to the first toe phalanx length will be calculated and recorded. The relationship between the hallux valgus angle, toe lengths, and their ratios will be analyzed using statistical methods.


Eligibility criteria: Inclusion Criteria:

* Age between 60-80 years
* Presence of foot radiographs suitable for measurement
* No history of prior foot surgery

Exclusion Criteria:

* History of foot trauma or fractures
* Previous foot or toe surgery
* Presence of congenital foot deformities
* Neurological or rheumatologic conditions affecting foot structure
* Severe osteoarthritis or other degenerative foot diseases visible on radiographs

Primary outcomes:
measure: Hallux Valgus Angle
timeFrame: 0 day
Secondary outcomes:
measure: First Intermetatarsal Angle
timeFrame: 0 day
measure: First Toe (Hallux) Metatarsal and Phalanx Lengths
timeFrame: 0 day
measure: Second Toe Metatarsal and Phalanx Lengths
timeFrame: 0 day
measure: Second Toe to First Toe Phalanx Length Ratio
timeFrame: 0 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Beylikdüzü State Hospital
state: Beylikdüzü
Study officials:
References:
Clinical trial NCT04355117: A Safety Evaluation Trial of TEV-48125 Self-administered in Migraine Patients
Official title: A Multicenter, Open-label Trial to Evaluate the Safety of TEV-48125 When Subcutaneously Self-administered in Migraine Patients at the Trial Site and at Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-04-21
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial assesses the safety of TEV-48125 when subcutaneously self-administered in Japanese migraine patients using an autoinjector (AI) at home. Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses. The first dose will be self-administered at the trial site under the supervision of the investigator and the second dose will be self-administered at home.


Eligibility criteria: Inclusion Criteria:

* Patient has a history of migraine (according to the ICHD-3 criteria) diagnosis for ≥12 months prior to giving informed consent.
* Patient fulfills any of the migraine criteria(according to the ICHD-3 criteria) on ≥4 days in baseline information collected during the 28-day screening period

Exclusion Criteria:

* History of hypersensitivity reactions to injected proteins, including monoclonal antibodies
* Prior exposure to a monoclonal antibody targeting (CGRP) pathway meeting the following conditions:

  * Less than 5 months has passed since the final administration of AMG334, ALD304, or LY2951742.
  * Less than 1 year has passed since the final administration of TEV-48125

Primary outcomes:
measure: Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
timeFrame: [1] Baseline (Day 1) to Day 28, [2] Visit 3 (Day 29) up to end of treatment (Day 57)
Secondary outcomes:
measure: Execution Status of Self-administration - Amount of Drug Solution Remaining in the AI
timeFrame: Baseline (Day 1) and Visit 3 (Day 29)
measure: Execution Status of Self-administration - Leakage of Drug Solution on the Skin
timeFrame: Baseline (Day 1) and Visit 3 (Day 29)
measure: Subject Compliance With the Self-administration Procedure
timeFrame: Baseline (Day 1) and Visit 3 (Day 29)
measure: Number of Deficiencies With the AI Device
timeFrame: Baseline (Day 1) and Visit 3 (Day 29)
Other outcomes:
Locations:
city: Sendai
country: Japan
facility: Sendai Zutsu No-Shinkei Clinic
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Takehisa Matsumaru
role: STUDY_DIRECTOR
References:
Clinical trial NCT05120817: Emphasizing the Personal Versus the Social in Educational Interventions For Decreasing Vaccine Hesitancy
Official title: Me or We? Emphasizing the Personal Versus the Social in Educational Interventions For Decreasing Vaccine Hesitancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaccine Hesitancy
Communication
Keywords: vaccine hesitancy
education
COVID-19 vaccine
Lead sponsor: National Research University Higher School of Economics
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2021-11-15
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This experimental study aims to investigate the effect of different types of educational interventions on overcoming Coronavirus disease 2019 (COVID-19) vaccine hesitancy among the Higher School of Economics (HSE) bachelor students in Russia.

Detailed description: The researchers aim to investigate the effectiveness of three types of educational interventions on overcoming COVID-19 vaccine hesitancy among the HSE bachelor students. The study design implies the comparison of three types of educational interventions which differ in the message that they deliver to the participants: the personal, the social, and a combination of the two. The effects of these interventions will be compared to the control group with no intervention.

Participants in these three experimental groups will receive a link to an educational video about the benefits and costs of vaccination against COVID-19. The videos for the three groups will contain information about vaccination, but each of them will have a different focus.

The participants will be hired on a voluntary basis. All the participants will sign the informed consent form, and the measures will be taken to ensure that their personal data will be protected.

Eligibility criteria: Inclusion Criteria:

* HSE bachelor students from 18 to 25 years old, who agreed to participate in the study.

Exclusion Criteria:

* Students who have got vaccinated already.

Primary outcomes:
measure: Real vaccination status
timeFrame: 1-3 months
Secondary outcomes:
measure: Knowledge, attitudes, and self-reported behaviors
timeFrame: 1-3 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Higher School of Economics
Study officials:
affiliation: Stanford University
name: Prashant Loyalka, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03215017: Effect of Treatment of Low Anterior Resection Syndrome After Rectal Cancer Surgery
Official title: A Randomized Controlled Study of the Effect of Treatment of Low Anterior Resection Syndrome (LARS) After Rectal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Anterior Resection Syndrome
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2017-07-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial (RCT) in patients who underwent sphincter preserving surgery due to rectal cancer. The study will analyze the effect of Transanal irrigation (TAI) and medication that can help control of the bowel movement in patients with low anterior resection syndrome.

Detailed description: A randomized controlled trial (RCT) in patients who underwent sphincter preserving surgery due to rectal cancer.

The study will analyze the effect of Transanal irrigation (TAI) and medication that can help control of the bowel movement in patients with low anterior resection syndrome.

An interim analysis will be made after 40 included patients in the study.

Eligibility criteria: Inclusion Criteria:

* Patients that have undergone surgery for rectal cancer (sphincter saving surgery, low anterior resection)
* Adult ≥ 18 years old
* Have scoring major LARS (according to the Low anterior resection syndrome score)

Exclusion Criteria:

* stoma
* recurrent disease
* Another colorectal surgery
* Inflammatory bowel disease (IBD)

Primary outcomes:
measure: Bowel function
timeFrame: 1 year
measure: Bowel function, Low anterior resection syndrome (LARS)
timeFrame: 1 year
Secondary outcomes:
measure: Quality of Life (QoL)
timeFrame: 1 year
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Danderyd Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Stockholm
country: Sweden
facility: Stockholm South General Hospital
Study officials:
affiliation: Karolinska Institutet
name: Mirna Abraham-Nordling, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pieniowski EHA, Bergstrom CM, Nordenvall CAM, Westberg KS, Johar AM, Tumlin Ekelund SF, Larsson KR, Pekkari KJ, Jansson Palmer GC, Lagergren P, Abraham-Nordling M. A Randomized Controlled Clinical Trial of Transanal Irrigation Versus Conservative Treatment in Patients With Low Anterior Resection Syndrome After Rectal Cancer Surgery. Ann Surg. 2023 Jan 1;277(1):30-37. doi: 10.1097/SLA.0000000000005482. Epub 2022 Jul 7.
Clinical trial NCT00303017: Safety, Efficacy and Acceptability of Flavocoxid (Limbrel)A Pilot Study
Official title: Safety, Efficacy and Acceptability of Flavocoxid (Limbrel) Compared With Naproxen in Subjects With Osteoarthritis of the Knee. A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Primus Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: safety, efficacy and acceptability of Flavocoxid

Detailed description: Safety, Efficacy and acceptability of Flavocoxid (Limbrel) compared with Naproxen in Subjects with Osteoarthritis of the Knee. A Pilot Study

Eligibility criteria: Inclusion Criteria:

OA of the knee,K-L grade 2-3 in general good health is currently taking an NSAID or COX-2 inhibitor -

Exclusion Criteria:

pregant or nursing women grade 1 or 4 OA any significant medical condition that in the opinion of the physician might put the subject at risk in this study any form of arthropathy other than OA any condition that might confound the evaluation of the pain, stiffness or function of the target joint intra-articular cotticosteroid inkection in the target joint within 3 month of the screening visit concomitant use of other anti-inflammatory or anti arthritic medication or products(including OTC and herbal preparations) Low dose aspirin for cardio-protection is allowed concomitant use of coumadin or other anticoagulant or anti-platelet medication concomitant use of gastro-protectiv medications including, but not limited to, H2 blockers and proton pump inhibitors, including OTC and herbal products History of allergy to Flavonoids

-

Primary outcomes:
measure: compare efficacy
Secondary outcomes:
measure: evaluate safety
Other outcomes:
Locations:
city: Melbourne
country: United States
facility: Timothy Truitt MD
state: Florida
Study officials:
affiliation: Sun Valley Arthritis Ltd, 6525 W. Sack Drive Suite 108 Glendale AZ 85308 Phone 623-825-5591 Fax 623
name: Joy Schechtman, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: MIMA Century Research Associates 65 E. Nasa Blvd. Suite 106 Melbourne FL 32901 Phone 321 723-1203 Fax 321-725-3602
name: Timothy Truitt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levy RM, Saikovsky R, Shmidt E, Khokhlov A, Burnett BP. Flavocoxid is as effective as naproxen for managing the signs and symptoms of osteoarthritis of the knee in humans: a short-term randomized, double-blind pilot study. Nutr Res. 2009 May;29(5):298-304. doi: 10.1016/j.nutres.2009.04.003.
Clinical trial NCT04270617: The Effect of Yoga Practice on Chronic Back Pain
Official title: A Prospective, Randomized-controlled Study to Evaluate the Effect of a Standardized Yoga Practice on Chronic Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Back Pain
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic low back pain is notoriously difficult to treat and is a primary contributor to lost work days and excessive health expenditures, and whose treatment has, in part, contributed to the opioid crisis. Surgery is only an option in a minority of these patients, usually confined to those with structural instability. Yoga is an ancient modality whose benefits are currently being studied.

Detailed description: The purpose of this research study is to determine whether a 6 week standardized yoga practice is superior to usual conservative therapies in the treatment of chronic back pain at 6 months. There is enough data that the most recent ACP guidelines have included yoga as a treatment for chronic back pain, but more data needs to be generated regarding the efficacy of this modality in treating the chronic back pain population.

Eligibility criteria: Inclusion Criteria:

* Willingness to and ability to participate in study procedures
* Chronic back pain (pain above the gluteal cleft of at least 3 months duration)

Exclusion Criteria:

* Indication for surgery (i.e., fracture, infection, scoliosis, spondylolisthesis)
* Cardiac, pulmonary or other medical comorbidities that preclude participation in yoga practice

Primary outcomes:
measure: Changes in VAS(visual analog scale)
timeFrame: Enrollment visit, 6 months after enrollment visit
measure: Changes in ODI (Oswestry Disability Index)
timeFrame: Enrollment visit, 6 months after enrollment visit
measure: Changes in SF-36 (Short Form (36) Health Survey )
timeFrame: Enrollment visit, 6 months after enrollment visit
Secondary outcomes:
measure: Long term changes in VAS after intervention
timeFrame: Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit
measure: Long term changes in ODI after intervention
timeFrame: Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit
measure: Long term changes in SF-36 after intervention
timeFrame: Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit
Other outcomes:
Locations:
city: New York
country: United States
facility: NYULangone
state: New York
Study officials:
affiliation: NYU Langone Health
name: Erich Anderer
role: PRINCIPAL_INVESTIGATOR
References: