louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06724198: Bowel Dysfunction After Low Rectal Resection. An Pilot Study Using Psyllium Husk In Rectal Cancer Patients.
Official title: Quality of Life (QoL) and Symptom Burden After Low Rectal Resection. An Open, Effect Pilot Study With Psyllium Husk Treatment in Rectal Cancer Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Anterior Resection Syndrome
Quality of Life (QOL)
Keywords: rectal cancer, LARS, quality of life, Psyllium
Lead sponsor: Sykehuset Telemark
Sponsor class: OTHER_GOV
First posted: 2024-12-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label, effect study
Primary purpose: TREATMENT

Brief summary: Rectal cancer constitutes 1/3 of more than 4500 annually diagnosed cases of colorectal (CRC) in Norway. With the advances in radiochemotherapy, and surgical techniques, the long-term survival rate is increasing after surgery regardless of the rising incidences, with a 73% 5-year survival rate in Norway (89% for stage I-III cancer). Low anterior resection (LAR) is the most commonly performed surgical procedure with curative intent with over 500 procedures per year in Norway alone. 80 % of patients subjected to LAR suffer from the LAR syndrome (LARS) which includes grades of bowel incontinence, urgency and tenesmus contributing to reduced quality of life (QoL). Suggested means of management have been advocated without preceding randomized trials. Psyllium husk has been suggested as a nutritional supplement for symptom reduction in patients suffering from LARS, but data is limited and no larger, randomized studies regarding its effect on patients with low anterior resection syndrome have been conducted. In this pilot study preceeding a placebo-controlled RCT, the investigators aim to improve documentation of a proposed management strategy. The investigators anticipate that a reduction in intestinal symptomburden will increase QoL for this large patientgroup.


Eligibility criteria: Inclusion Criteria:

* Operated with low rectal resection for rectal cancer
* LARS score \>20 at 12 months or more after surgery
* Written consent

Exclusion Criteria:

* Various conditions rendering the patient unable to answer questionnaire
* LARS score 0-20
* Contraindications to Psyllium husk (hypersensitivity, intestinal obstruction, reduced esophageal function, rare congenital medical conditions such as sucrase-isomaltase deficiency, fructose intolerance and glucose-galactose malabsorbtion)

Primary outcomes:
measure: LARS score
timeFrame: At baseline, at 4 and 8 weeks of intervention
Secondary outcomes:
measure: Quality of Life (QoL)
timeFrame: At baseline, at 4 and 8 weeks of intervention
Other outcomes:
Locations:
city: Skien
country: Norway
facility: Sykehuset Telemark HF
state: Telemark
Study officials:
affiliation: Sykehuset Telemark
name: Silje S Holte
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02843698: Effects of Dexmedetomidine on Oxygenation and Lung Mechanics in Morbidly Obese Patients Undergoing Bariatric Operations
Official title: Effects of Dexmedetomidine on Oxygenation and Lung Mechanics in Morbidly Obese Patients Undergoing Bariatric Operations: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Restrictive Lung Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 42
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: The study aims to investigate the effect of dexmedetomidine on oxygenation and lung mechanics in morbidly obese patients

Detailed description: The patients of interest are morbid obese patients scheduled for bariatric surgery. Dexmeditomidine will be infused intraoperatively after induction of anesthesia. lung mechanics (dead space and compliance) as well as oxygenation (PF ratio) will be monitored intraoperatively and postoperatively

Eligibility criteria: Inclusion Criteria:

- Morbid obese (body mass index \> 40) with documented restrictive lung disease scheduled to bariatric operation.

Exclusion Criteria:

* Heart failure
* ِِِِArrhythmia
* Heart block
* Severe liver or kidney impairment.

Primary outcomes:
measure: Oxygenation
timeFrame: 2 hours
Secondary outcomes:
measure: Lung mechanics
timeFrame: 2 hours
measure: arterial blood pressure
timeFrame: 2 hours
measure: plateau airway pressure
timeFrame: 2 hours
measure: heart rate
timeFrame: 2 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Head of research committee section in anesthesia department
name: Ahmed Mukhtar, Professor
role: STUDY_DIRECTOR
References:
citation: Hasanin A, Taha K, Abdelhamid B, Abougabal A, Elsayad M, Refaie A, Amin S, Wahba S, Omar H, Kamel MM, Abdelwahab Y, Amin SM. Evaluation of the effects of dexmedetomidine infusion on oxygenation and lung mechanics in morbidly obese patients with restrictive lung disease. BMC Anesthesiol. 2018 Aug 14;18(1):104. doi: 10.1186/s12871-018-0572-y.
Clinical trial NCT05420298: Short Term Effect of Cervical Mobilization vs Manipulation on Blood Pressure in Hypertensive Subjects
Official title: Short Term Effect of Cervical Mobilization vs Manipulation on Blood Pressure in Hypertensive Subjects( Randomized Control Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 27
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spinal pain or misalignment is a very common disorder affecting a significant number of populations resulting in substantial disability and economic burden. Various manual therapeutic techniques such as spinal manipulations and mobilizations can be used to treat and manage pain and movement dysfunctions such as spinal malalignments and associated complications. These manual therapeutic techniques can affect the cardiovascular parameters .

-

Detailed description: Group A group (n=20). All participants will receive only single session of neck mobilization. Grade IV unilateral posteroanterior pressure and sustained extension to be applied restricted joints and muscle energy technique.

- Group B (n=20) will receive single session of neck manipulation with high-velocity, low-amplitude thrust over restricted joints (one at a time) with the goal of restoring normal range of motion in the joint.

Eligibility criteria: Inclusion Criteria:

* SBP ranging from 135 to 159 mm Hg or DBP ranging from 85 to 99 mm Hg over 3 qualifying BP screening visits
* The age of participants will range from 27 to 60 years old.
* Body mass index of participants will range between \< 39 kg/m².

Exclusion Criteria:

* cardiovascular diseases or surgery, including second- or third-degree heart block, angina pectoris, defibrillator, valvular disease, recent myocardial infarction, cardiac surgery in the past 12 months.
* history of stroke.
* body mass index (BMI) greater than 39 kg/m2.
* pregnancy.

Primary outcomes:
measure: systolic blood pressure measurement
timeFrame: it will be measured immediately before and after single session treatment
Secondary outcomes:
measure: diastolic blood pressure
timeFrame: it will be measured immediately before and after single session treatment
measure: oxygen saturation
timeFrame: it will be measured immediately before and after single session treatment
measure: perfusion index
timeFrame: it will be measured immediately before and after single session treatment
measure: pain assessment
timeFrame: it will be measured immediately before and after single session treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT00229398: Medical and Psychiatric Co-Morbidity Among Treatment Resistant Patients With Major Depression Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-09-29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE

Brief summary: Assessing psychiatric and physiological co-morbidity in TRD and non-TRD patients


Eligibility criteria: Inclusion Criteria:

* Diagnosis of MDD
* Received at least one adequate treatment

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tel Aviv University
name: Joseph Zohar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05356598: Help-seeking Intentions of ROTC Trainees
Official title: Impact of Peer-delivered Versus Authority-delivered Information on Help-seeking Intentions of ROTC Trainees
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Help-Seeking Behavior
Musculoskeletal Injury
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Online survey measuring pre-post stigma and intentions to seek care for musculoskeletal injuries using peer and authority-delivered health promotion videos.

Detailed description: The survey will be hosted via QualtricsXM and accessible via an anonymous link. When participants open the survey, they will be presented with the survey's information sheet explaining the study's purpose and procedures. The information sheet will make it clear that completing the survey is voluntary and cadets may cease the survey at any time. Data from unfinished surveys will not be included in final analyses for any reports produced from this survey. Participants will complete demographics questions. Then, participants will answer injury reporting intentions and stigma questions, presented in a randomized order to reduce respondent fatigue. Participants will then watch a health promotion video that encourages reporting musculoskeletal injuries while in ROTC. Participants have the potential to be shown one of three videos: an officer-delivered health promotion, cadet-delivered health promotion, and a video of an officer exercising. Participants will be randomly assigned to one of the three videos using the in-built randomization function within Qualtrics. After watching the video, participants will answer the stigma and intentions questions again. After, participants will be asked to provide an email address that will be used to send them a link to complete the survey a second time. The follow-up portion will ask for their unique identifier as described above and have the participants answer the stigma and intentions questions again. All data will be de-identified when exporting responses from Qualtrics. No reference will be made to any individual participant in any way when presenting or reporting these data.

Eligibility criteria: Inclusion Criteria:

* Age 18-39
* Actively participating in a college or university senior ROTC program (Army, Air Force, or Naval)

Exclusion Criteria:

* Anyone who does not meet inclusion criteria

Primary outcomes:
measure: Changes in Stigma and Help-seeking Intentions Measured Before and After Health Promotion with Three-week Follow-up
timeFrame: Three weeks (baseline, immediately post intervention, and three weeks post intervention)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Nevada, Las Vegas
name: Kara Radzak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00803998: Ocular Hypertension Treatment Study (OHTS)
Official title: Ocular Hypertension Treatment Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ocular Hypertension
Glaucoma
Lead sponsor: The New York Eye & Ear Infirmary
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2008-12-08
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: The Ocular Hypertension Treatment Study is a multi-center clinical trial sponsored by the National Eye Institute, designed to determine the efficacy and safety of topically administered eye lowering medication


Eligibility criteria: Inclusion Criteria:

* Qualifying IOP in at least one eye of each participant must be more than or equal 24 mmHg but less than or equal to 32 mm HG calculated from two separate consecutive determination taken at least 2 hours, but not greater than 12 weeks apart.
* Normal and reliable 30-2 Humphrey Visual Fields in both eyes.
* Normal Optic disc in both eyes on clinical examinations and stereoscopic photographs as determined by the Optic Disc Reading Center.

Exclusion Criteria:

* Visual acuity worse than 20/40 in either eye on qualifying exam.
* Previous intraocular surgery: laser trabeculoplasty, laser iridotomy, filtering surgery, combined cataract extraction/filtering procedures, penetrating keratoplasty and retinal detachment repair.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine at St. Louis, St. Louis, Missouri
name: Michael Kass, MD
role: STUDY_CHAIR
References:
citation: Gordon MO, Beiser JA, Brandt JD, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Kass MA. The Ocular Hypertension Treatment Study: baseline factors that predict the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):714-20; discussion 829-30. doi: 10.1001/archopht.120.6.714.
Clinical trial NCT02219698: Symptomatic Treatment of Acute Uncomplicated Diverticulitis
Official title: Symptomatic Treatment of Acute Uncomplicated Diverticulitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diverticulitis
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Vatsatautien tutkimussäätiö - foundation
name: Mary and Georg Ehrnroot's foundation
name: Finnish Surgical society
name: Martti I. Turunen Foundation
name: Governmental competitive funds (EVO)
First posted: 2014-08-19
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and efficacy of symptomatic treatment (i.e. without antimicrobial drugs) of acute uncomplicated diverticulitis.


Eligibility criteria: Inclusion Criteria:

* Computed tomography-diagnosed acute uncomplicated\* diverticulitis

  * No abscess, fistula, obstruction and distant intra- or retroperitoneal air. Pericolic air allowed.

Exclusion Criteria:

* Already commenced antimicrobial medication
* Immunosuppression (e.g. diabetes, corticosteroid medication, immunosuppressive medication, chemotherapy, chronic liver disease)
* Suspicion of generalized peritonitis
* Organ dysfunction
* Another infection requiring antimicrobial medication
* Pregnancy
* Age \< 18 years or \> 90 years
* Missing written consent

Primary outcomes:
measure: Complications of diverticulitis
timeFrame: 30 days from allocation
Secondary outcomes:
measure: Length of hospital stay (days)
timeFrame: At the end of the hospital stay, an expected average of 2 days
measure: Rate of re-admissions
timeFrame: 30 days from discharge
measure: Recurrence of diverticulitis
timeFrame: 10 years
measure: Mortality
timeFrame: 30 days from allocation
measure: Need for elective sigmoid resection
timeFrame: 10 years
measure: Need for emergency surgery for diverticulitis on another admission
timeFrame: 10 years
measure: Commencement of antimicrobial drug
timeFrame: For the duration of hospital stay, an expected average of 2 days
measure: Late complication of diverticulitis
timeFrame: 10 years
measure: Stoma rate
timeFrame: 10 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
Study officials:
References:
citation: Mali JP, Mentula PJ, Leppaniemi AK, Sallinen VJ. Symptomatic Treatment for Uncomplicated Acute Diverticulitis: A Prospective Cohort Study. Dis Colon Rectum. 2016 Jun;59(6):529-34. doi: 10.1097/DCR.0000000000000579.
Clinical trial NCT02397798: Improved Ability to Cope With Everyday Life Through a Person-centered Training Program in Elderly Patients With Rheumatoid Arthritis - PEP-walk Study
Official title: Improved Ability to Cope With Everyday Life Through a Person-centered Training Program in Elderly Patients With Rheumatoid Arthritis - PEP-walk Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2015-03-25
Enrollment: 75
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to examine whether person-centered high-intense aerobic / strength training during five months reduces inflammation and disease activity, improve immune cell function, and increases muscle strength, fitness and ability of the individual independence in elderly patients with rheumatoid arthritis.


Eligibility criteria: Inclusion

* Patients 65 years or older with RA diagnosed according to the ACR / EULAR 1987/2010 criteria,
* disease duration 2 years or more,
* disease activity as measured by DAS28 \<5.1

Exclusion

* Comorbidities, such as unstable coronary artery disease, uncontrolled cardiac arrhythmia, or uncontrolled high blood pressure, which prevents moderate to intense exercise.
* Joint surgery completed within 6 months prior to study entry.
* Ongoing training at moderate to high level 2 or more times per week

Primary outcomes:
measure: Ability to manage daily activities as measured by the rheumatoid arthritis-specific measure of the Health Assessment Questionnaire (HAQ).
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: VastraGotaland
Study officials:
References:
citation: Andersson SEM, Lange E, Kucharski D, Svedlund S, Onnheim K, Bergquist M, Josefsson E, Lord JM, Martensson IL, Mannerkorpi K, Gjertsson I. Moderate- to high intensity aerobic and resistance exercise reduces peripheral blood regulatory cell populations in older adults with rheumatoid arthritis. Immun Ageing. 2020 May 16;17:12. doi: 10.1186/s12979-020-00184-y. eCollection 2020.
citation: Lange E, Kucharski D, Svedlund S, Svensson K, Bertholds G, Gjertsson I, Mannerkorpi K. Effects of Aerobic and Resistance Exercise in Older Adults With Rheumatoid Arthritis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2019 Jan;71(1):61-70. doi: 10.1002/acr.23589.
Clinical trial NCT01424098: Balance Training in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Randomized Controlled Trial of Balance Training in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: West Park Healthcare Centre
Sponsor class: OTHER
Collaborators: name: Ontario Lung Association
First posted: 2011-08-26
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A growing body of evidence suggests that individuals with chronic lung disease have important deficits in balance control that may be associated with an increased risk of falls. The main purpose of this study is to examine the effects of a balance training program on measures of balance and fall risk in people with chronic lung disease.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD; a self-report of decline in balance or fall in the last 5 years or a recent near fall; smoking history greater than 10 pack years; and are able to provide written informed consent.

Exclusion Criteria:

* Inability to communicate because of language skills, hearing or cognitive impairment; and evidence of a neurological or musculoskeletal condition that severely limits mobility and postural control (e.g., cerebrovascular accident, advanced Parkinson's disease, amputation).

Primary outcomes:
measure: Berg Balance Scale
timeFrame: All outcomes will be assessed upon admission to pulmonary rehabilitation (baseline) and again upon completion of the program, an expected average of 6 weeks from baseline.
measure: Balance Evaluation Systems Test
timeFrame: At baseline and 6 weeks.
Secondary outcomes:
measure: Balance confidence/falls self-efficacy
timeFrame: At baseline and 6 weeks.
measure: Functional strength
timeFrame: At baseline and 6 weeks.
measure: Self-reported physical function
timeFrame: At baseline and 6 weeks.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: West Park Healthcare Centre
state: Ontario
Study officials:
affiliation: University of Toronto
name: Dina Brooks, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: West Park Healthcare Centre
name: Roger S Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Marla K Beauchamp, MSc.PT
role: STUDY_CHAIR
affiliation: West Park Healthcare Centre
name: Tania Janaudis-Ferreira, PhD
role: STUDY_CHAIR
References:
citation: Beauchamp MK, Janaudis-Ferreira T, Parreira V, Romano JM, Woon L, Goldstein RS, Brooks D. A randomized controlled trial of balance training during pulmonary rehabilitation for individuals with COPD. Chest. 2013 Dec;144(6):1803-1810. doi: 10.1378/chest.13-1093.
Clinical trial NCT00014898: Attention Deficit Disorder and Exposure to Lead
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Disorder
Keywords: Lead exposure
Bone lead
Attention deficit
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-04-13
Enrollment: 500
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE

Brief summary: We are examining the past exposure to lead in 250 well characterized children with ADHD, and a suitable group of controls. Our measure of past exposure is bone lead levels obtained by XRay fluorescence spectroscopy, a relatively new way of estimating bone lead concentrations, and by inference, body lead burdens. By comparing the lead concentrations in these two groups, controlling for other factors which could confound, we will estimate odds ratios for ADHD given elevated bone lead, and estimate the contribution of lead to this disease of childhood.


Eligibility criteria: Case subjects are drawn from adolescents aged 10 to 18 previously seen at Western Psychiatric Institute and Clinic for evaluation, and meet the DSM-IIIR criteria for diagnosis of ADHD based on a structured parent interview and standardized parent and teacher rating scales. Cases were also systematically observed and evaluated in the summer treatment program between 1987 and 1996 at WPIC. Controls are demographically matched non-ADHD adolescents, recruited from surrounding communities and pediatric practices.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References: