louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01233817: Progressive Strength Training in Spinal Muscular Atrophy
Official title: Pilot Study of Progressive Strength Training in Spinal Muscular Atrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Atrophy, Spinal
Keywords: Spinal muscular atrophy
Neuromuscular disorder
Progressive strength training
Children
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2010-11-03
Enrollment: 12
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed feasibility study is necessary to test if children and young adults will participate in and adhere to a 12-week, home-based, supervised progressive strength training exercise program and to obtain preliminary data that will subsequently allow us to determine the safety and impact of strength training in spinal muscular atrophy. Our pilot study will address 3 aims: (1) Ascertain the feasibility of, and potential barriers to, participation in and adherence to a 12-week home-based, supervised, progressive strength training exercise program in children and young adults aged 5-21 years with SMA types II and III; (2) Determine the safety and tolerability of progressive strength training in a pilot study sample of children and young adults with SMA types II and III; and (3) Determine candidate outcome measures.


Eligibility criteria: Inclusion Criteria:

* age 5-21 years
* diagnosis of SMA type II or III
* at least antigravity strength in elbow flexors
* ability to follow commands and stay on task
* place of residence within a 60-minute or 60-mile drive of the University of Utah

Exclusion Criteria:

* planned surgery or out-of-town trips during the proposed intervention period
* inability to travel to study center for testing
* neurological diagnosis other than SMA

Primary outcomes:
measure: Strength
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Aga Lewelt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03967717: Correlation of Clinical and Laboratory Findings and Diuretic Efficacy in Patients With Edematous States in the Emergency Department
Official title: Correlation of Clinical and Laboratory Findings and Diuretic Efficacy in Patients With Edematous States in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Edema
Keywords: Edema
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion of patients with edematous states of cardiac or renal genesis. Patients with liver cirrhosis and in need of ascites puncture and/or thoracentesis are excluded.

Brief summary: The aim of the study is the characterization of parameters from medical history, physical examination and diagnostics, which correlate with and could be used to predict diuretic efficacy.

Detailed description: This prospective observational study is conducted to identify and further isolate possible predictors for the efficacy of diuretics and to identify potential new predictors.

The study also observes if specific diuretic regimes (e.g. combination of loop diuretics and distal effective diuretics for sequential nephron blockade) have a greater diuretic effect. This is not yet proved.

The data of the study shall to help to determine criteria, allowing to choose an effective diuretic regime in different patient cohorts already at the beginning of therapy and to identify patients at high risk.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years.
* Edema (peripheral and/or pulmonal) of cardiac or renal genesis.

Exclusion Criteria:

* Persons who are in a dependency/employment relationship with the investigators.
* Accommodation in an institution by judicial or administrative order.
* Patients in need of ascites puncture and/or thoracentesis on admission day.

Primary outcomes:
measure: Multivariable regression analysis at 6±1 hours
timeFrame: 6±1 hours from timepoint of first diuretic administration in the emergency department
measure: Multivariable regression analysis 24 hours time course
timeFrame: 24 hours time course from timepoint of first diuretic administration in the emergency departmentnistration
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
Study officials:
affiliation: University Hospital of Cologne
name: Volker Burst, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01392417: Anterior Prolift Versus Posterior Prolift for Pelvic Floor Prolapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Floor Prolapse
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2011-07-12
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with pelvic floor prolapse who underwent surgery with Prolift

Brief summary: Women who had surgery for pelvic floor prolapse underwent surgery by anterior Prolift or Posterior prolift at least a year after the surgery.

The data from the charts and from telephone conversations with the patients will be entered to a database. Physical examination data will also be incorporated.


Eligibility criteria: Inclusion Criteria:

* Women who underwent surgery by anterior Prolift or posterior Prolift for pelvic floor prolapse

Exclusion Criteria:

* Women who did not have surgery by Prolift for pelvic floor prolapse

Primary outcomes:
measure: Symptoms of pelvic floor prolapse
timeFrame: One year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Department of Obstetrics and Gynecology, Western Galilee Hospital
city: Tel Aviv
country: Israel
facility: Clinics of Dr Neuman
Study officials:
References:
Clinical trial NCT01839617: Study Comparing Early and Late Nutrition in Cancer Patients Undergoing Abdominal Surgery
Official title: Early Versus Late Parenteral Nutrition in Cancer Patients Undergoing Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Abdominal Surgery
Parenteral Nutrition
Keywords: parenteral nutrition
early nutrition
abdominal surgery
cancer
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 335
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: The aim of this study is to find which is the best nutritional strategy in cancer patients undergoing abdominal surgery regarding postoperative complications.

Detailed description: There is a controversy regarding the timing of initiation of parenteral nutrition in cancer patients undergoing abdominal surgery in whom caloric targets cannot be met by enteral nutrition alone.

This is a randomized and controlled trial comparing early initiation with late initiation of parenteral nutrition.

Early-initiation group: patients will be randomized to initiate parenteral nutrition in the 2nd day after surgery.

Late-initiation group: patients will be randomized to initiate parenteral nutrition in the 7th day after surgery.

Calculations regarding the caloric goal included protein energy and were based on corrected ideal body weight, age and sex. When oral or enteral nutrition covered 80% of the calculated caloric goal, parenteral nutrition was reduced and progressively stopped.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years
* Laparotomy for abdominal cancer surgery: urological, gynecological, digestive, abdominal sarcomas and melanomas, lymphomas and abdominal vascular.
* Informed consent form signed by the patient or legal guardian.

Exclusion Criteria:

* Reoperation within one year from the previous surgery. using previously parenteral nutrition.
* Participation in another research protocol.

Primary outcomes:
measure: Clinical complications
timeFrame: 30 days
Secondary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Length of stay in ICU and in hospital
timeFrame: 30 days
measure: ICU readmission rate
timeFrame: 30 days
measure: Duration of pharmacologic hemodynamic support
timeFrame: 30 days
measure: Levels of C-reactive protein
timeFrame: 7 days
measure: Duration of mechanical ventilation
timeFrame: 30 days
measure: Liver dysfunction
timeFrame: 30 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: ICESP
state: SP
city: São Paulo
country: Brazil
facility: Cancer Institute of the State of Sao Paulo
state: SP
Study officials:
affiliation: Instituto do Cancer do Estado de São Paulo
name: Patricia Marques, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02279017: mHealth Messages to Sustain Recent Weight Loss - Phase 2
Official title: Mobile Health Messages to Sustain Recent Weight Loss - Phase 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Keywords: Mobile Technology
Diet and Fitness
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-10-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To assess the feasibility to translate an automated weight loss message intervention to a weight loss clinic population.

Aim 1: To assess feasibility of translating the intervention in a clinic for patients who recently completed a structured weight loss program.

Aim 2: To assess the ability to capture a trajectory of self-reported weight over 6 months through an automated intervention.

Detailed description: The investigators will recruit 100 participants who are clients at the Duke Diet and Fitness Center. At baseline the investigators will collect demographic information such as, their age, weight, education. When participants complete their respective program at the DFC they will receive a daily weight loss sustaining text message at 8:00 A.M. for 60 days. Participants will also receive weekly messages for 6 months asking them to self-report their weight. Thereafter, they will receive an automated message monthly for 18 months asking them to self-report their weight.

Eligibility criteria: Inclusion Criteria:

* A client of Duke diet and Fitness Center (DFC)
* Are able to speak and read English
* Should complete a diet and fitness program at the DFC.
* Client should own a mobile smart phone to personally receive text messages.
* Client should have access to a web-based survey to self-report their weight.

Exclusion Criteria:

* No exclusions

Primary outcomes:
measure: Subject's weight loss
timeFrame: 2 years
measure: Percentage of subjects who self-report weight to the clinic
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center, Diet and Fitness Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Ryan Shaw, RN, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00355017: BNP Guided Care in Addition to Multidisciplinary Care
Official title: NT-BNP Guided Care in Addition to Multidisciplinary Care in Patients With Chronic Heart Failure A Three-Arm, Prospective, Randomised Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Decompensated Heart Failure
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2006-07-20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: HF is associated with repeated hospitalisations and poor prognosis.The aim of this study is to investigate whether BNP-guided care (BGC) in addition to multidisciplinary management(MM) improves outcome compared to HNC alone or usual care (UC) for decompensated HF patients after discharge.

Patients hospitalised with cardiac decompensation in 9 Viennese hospitals are randomised to BGC, MM alone, or UC. MM includes 2 consultations of a heart failure (HF) specialist 10 days and 2 months after discharge for recommending medical optimisation and care by a specialised HF nurse including 4 home visits and telephone contact. In addition, BGC includes intensified increase of medical treatment during repeated follow-up visits in a HF clinic in patients with an Nt-BNP level above 2200pg/ml at discharge.


Eligibility criteria: Inclusion Criteria:

1. Clinical signs and symptoms of cardiac decompensation during the present hospitalisation
2. NYHA class III or IV at time of admission
3. Cardiothoracic ratio \> 0.5, and/or left ventricular ejection fraction \<40% documented by echocardiography

Exclusion Criteria:

-

Primary outcomes:
measure: Heart failure rehospitalisation rate;
measure: combined endpoint death or heart failure rehospitalisation;
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Vienna
name: Richard Pacher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berger R, Moertl D, Peter S, Ahmadi R, Huelsmann M, Yamuti S, Wagner B, Pacher R. N-terminal pro-B-type natriuretic peptide-guided, intensive patient management in addition to multidisciplinary care in chronic heart failure a 3-arm, prospective, randomized pilot study. J Am Coll Cardiol. 2010 Feb 16;55(7):645-53. doi: 10.1016/j.jacc.2009.08.078.
Clinical trial NCT04784117: Out-of-hospital Cardiac Arrest Epidemiology and Outcomes in Kaunas 2016-2021
Official title: Out-of-hospital Cardiac Arrest Epidemiology and Outcomes in Kaunas 2016-2021
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Out-Of-Hospital Cardiac Arrest
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Egle Vaitkaitiene
name: Dinas Vaitkaitis
name: Asta Krikscionaitiene
name: Ilona Kajokaite
name: Nerijus Mikelionis
First posted: 2021-03-05
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: OHCA patients of all ages more than 18 years-old with resuscitation commenced or continued by EMS personnel

Brief summary: Out-of-hospital cardiac arrest rate is common problem, because of high mortality rate. It is not clear incidence rate, epidemiology and outcomes in Lithuania and Kaunas city included.

Detailed description: This data reported according to UTSTEIN guidelines could be compared with other countries from the region although not much data is available, but it will be a baseline for future references about processes in patient management, demographics, incidence rate and OHCA outcomes.

Eligibility criteria: Inclusion Criteria:

* OHCA patients of all ages more than 18 years-old with resuscitation commenced or continued by EMS personnel were included.

Exclusion Criteria:

* obviously dead patients, were excluded

Primary outcomes:
measure: The detection of death will be shorter
timeFrame: 31 Dec 2021
Secondary outcomes:
measure: The survival rate will increase
timeFrame: 31 Dec 2021
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Kaunas city ambulance station
city: Kaunas
country: Lithuania
facility: Lithuanian university of health sciences hospital Kaunas clinics
Study officials:
References:
Clinical trial NCT06407817: Comparative Effects Of Spencer and Reverse Distraction Technique In Patients With Adhesive Capsulitis
Official title: Comparative Effects Of Spencer and Reverse Distraction Technique In Patients With Adhesive Capsulitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adhesive Capsulitis
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effects of spencer and reverse distraction technique in patients with adhesive capsulitis

Detailed description: Adhesive capsulitis, also known as frozen shoulder, is an inflammatory condition characterized by shoulder stiffness, pain, and significant loss of passive range of motion. Adhesive capsulitis has a prevalence of approximately 2% to 5% in the general population, with a mean onset of age of 55.

A randomized clinical trial will be conducted at Ibne Sina Hospital, Multan . Non probability convenience sampling technique will be applied on 50 patients who will be allocated through computerized randomization into group A \& group B to collect data. Group A will be given spencer technique and group B will be given reverse distraction technique along with baselines. The study will be completed within the time duration of ten months. Primary Outcome measures of the research will be pain, range of motion, function, muscle strength, disability and quality of life will be measured pre and post intervention. The whole treatment protocols will be given for four weeks. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility criteria: Inclusion Criteria:

* Age group 40-60 years
* Male and female
* Positive Capsular pattern (ER more limited than Abd which is more limited than IR)
* Limitation in shoulder ROM ; Flexion \<180 , Abduction \<180 , External Rotation \<50
* Patients of stage 2 and 3 of adhesive capsulitis

Exclusion Criteria:

* History of surgery of the affected shoulder
* Fractures in around the shoulder
* Neurological disorders leading to altered muscle activity
* Systemic arthritic conditions (RA, Osteoporosis)
* Disorders of the cervical spine

Primary outcomes:
measure: pain : numerical pain rating scale
timeFrame: 6 weeks
measure: range of motion : universal goniometer
timeFrame: 6 weeks
measure: shoulder pain and impairment : SPADI
timeFrame: 6 weeks
measure: 36-Item Short Form Health Survey questionnaire (SF-36)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Johar Pain Relief Center
state: Punjab
Study officials:
affiliation: Riphah International University
name: Rabiya Noor, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04192617: A Study to Evaluate the Safety and Efficacy of SM03 in Patients With Rheumatoid Arthritis Receiving Methotrexate
Official title: A Randomized,Placebo Controlled, Double-blind, Parallel Group, Phase II Study to Evaluate the Efficacy and Safety of SM03, Compared to Placebo, in Patients With Moderate-to-Severe Active Rheumatoid Arthritis Receiving Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: SinoMab BioScience Ltd
Sponsor class: INDUSTRY
First posted: 2019-12-10
Enrollment: 156
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: This study evaluated the safety and efficacy of SM03 compared to placebo in patients with active rheumatoid arthritis(RA) receiving methotrexate


Eligibility criteria: Inclusion Criteria:

* Adult patients 18-75 years of age.
* Rheumatoid arthritis (RA) for ≥ 12 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis.
* Moderate to severe active RA with swollen joint count (SJC) ≥ 8 (66 joint count), and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.
* At screening, either C-reactive protein (CRP) ≥ 0.6 mg/dL (6 mg/L), or Erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour, or Morning stiffness of joint for ≥ 45 minutes
* Inadequate response to methotrexate, having received and tolerated at a dose of 7.5-20 mg/week for ≥ 12 weeks, at a stable dose over the past 4 weeks.

Exclusion Criteria:

* Rheumatic autoimmune disease other than RA.
* Use of any biological DMARDs for RA within past 6 months.
* Concurrent treatment with any Disease Modifying Anti-Rheumatic Drug (DMARD) other than methotrexate
* Active infection, or history of serious or chronic infection

Primary outcomes:
measure: Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 4,8,12, 16
timeFrame: Week 4,8,12,16
measure: Percentage of Participants With an ACR50 Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants With an ACR70 Response at Week 24
timeFrame: Week 24
measure: Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Adverse Events
timeFrame: Week 0 to 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hostipal
Study officials:
References:
citation: Li J, Li M, Wu D, Zhou J, Leung SO, Zhang F. SM03, an anti-human CD22 monoclonal antibody, for active rheumatoid arthritis: a phase II, randomized, double-blind, placebo-controlled study. Rheumatology (Oxford). 2022 May 5;61(5):1841-1848. doi: 10.1093/rheumatology/keab699.