louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02702557: Unsupervised Elastic Band Exercises Performed by Frail Elderly Hospitalized Patients Monitored by the Bandcizer
Official title: Feasibility Study of Unsupervised Elastic Band Exercises Performed by Frail Elderly Hospitalized Patients Monitored by the Bandcizer as a Supplement to Usual Supervised Physiotherapy Sessions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly
Keywords: Frail Elderly
Elastic Band Exercises
Unsupervised Exercises
Monitoring Technology
Bandcizer
Adherence
Feasibility
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Aalborg University
name: Amager Hospital
name: Hvidovre University Hospital
name: University of Copenhagen
First posted: 2016-03-08
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This feasibility study investigates if frail elderly and hospitalized patients are able to perform unsupervised elastic band exercises as a supplement to their usual supervised physiotherapy sessions and how much training they perform during their hospitalization. It is also investigated how the frail elderly and the health personnel experiences the unsupervised elastic band exercises.


Eligibility criteria: Inclusion Criteria:

* Frail elderly and hospitalized patients with a minimal score of 5/15 measured by the Tilburg Frailty Indicator
* Able to read and understand Danish

Exclusion Criteria:

* Frail elderly and hospitalized patients with a score of \<5 measured by the Short Portable Mental Status Questionnaire
* Frail elderly and hospitalized patients where resistance training and physical activity is contraindicated (evaluated by a geriatrician and/or physiotherapist)

Primary outcomes:
measure: Total number of sets performed
timeFrame: From inclusion-discharge from hospital - up to 6 weeks
Secondary outcomes:
measure: The total number of repetitions performed
timeFrame: From inclusion-discharge from hospital - up to 6 weeks
Other outcomes:
measure: Mean deviation from the prescribed TUT per repetition in seconds during the course of the intervention
timeFrame: From inclusion-discharge from hospital - up to 6 weeks
measure: Difference in score of two tests: The 30-s chair stand and the de Morton Mobility Index (DEMMI)
timeFrame: From beginning of hospitalization to discharge from hospital - up to 6 weeks
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: North Region Denmark
Study officials:
affiliation: Department of Occupational Therapy and Physiotherapy, Aalborg University Hospital
name: Jane Andreasen, ph.d. stud.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rathleff CR, Bandholm T, Spaich EG, Jorgensen M, Andreasen J. Unsupervised progressive elastic band exercises for frail geriatric inpatients objectively monitored by new exercise-integrated technology-a feasibility trial with an embedded qualitative study. Pilot Feasibility Stud. 2017 Nov 13;3:56. doi: 10.1186/s40814-017-0202-3. eCollection 2017.
Clinical trial NCT01836757: Effect of Methyl-Sulphonyl-Methane on Osteoarthritis and Cartilage
Official title: The Effect of Methyl-Sulphonyl-Methane on Osteoarthritis and Joint Cartilage Associated With the Degeneration of the Chondrocyte
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Osteoarthritis
Keywords: osteoarthritis
CAM treatments
MSM
Lead sponsor: G.Papanikolaou Research Group
Sponsor class: OTHER
First posted: 2013-04-22
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To delineate the effect of MSM on osteoarthritis

Detailed description: Objective: To delineate the effect of MSM on osteoarthritis of large joints. Design: Randomized, double-blind, placebo-controlled trial including an intervention and a placebo group. One hundred men and women, with hip and/or knee OA to be divided in 2 groups. Intervention is either MSM 3 gr twice a day for 26 weeks (6 gr/day total) for one group and placebo for the other. Outcomes measured are the Western Ontario and McMaster University Osteoarthritis Index visual analogue scale (WOMAC), patient and physician assessments and SF-36 (overall health-related quality of life).

Eligibility criteria: Inclusion Criteria:

* Knee and hip OA
* men and women \>45 years of age

Exclusion Criteria:

* any other type of arthritis
* chronic pain syndrome
* arthroscopic surgery in the past 8 months
* intra-articular corticosteroidsin the past 8 months
* hyaluronic acid injections in the past 8 months
* narcotic pain killers use
* renal or hepatic disease
* body mass index (BMI) \>45 kg/m2
* cancer

Primary outcomes:
measure: Number of participants with improved Mobility
timeFrame: 26 weeks
Secondary outcomes:
measure: Pain Scores on the Visual Analog Scale
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: G. Papanikolaou Hospital
Study officials:
affiliation: Aristotle's University of Thessaloniki
name: Thomas Pagonis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02836457: ELIQUIS (APIXABAN) Regulatory Post-Marketing Surveillance In Clinical Practice for Venous Thromboembolism (VTE) Treatment and Prevention Of Recurrent VTE
Official title: ELIQUIS (APIXABAN) Regulatory Post-Marketing Surveillance In Clinical Practice for Venous Thromboembolism (VTE) Treatment and Prevention Of Recurrent VTE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-07-19
Enrollment: 1134
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: The primary objectives of this study is to estimate the real-world safety profile of Eliquis in Japanese Venous Thromboembolism patients and to estimate the risk factors likely to affect the incidence of bleeding. Lastly, the secondary objective of this study is to estimate the real-world effectiveness profile of Eliquis in Japanese Venous Thromboembolism patients.


Eligibility criteria: Inclusion Criteria:

* Patients who are initiating Eliquis for the treatment of VTE or prevention of recurrent VTE for the first time

Exclusion Criteria:

* Prior treatment with Eliquis for nonvalvular atrial fibrillation or VTE
* Patients initiating Eliquis for the treatment of atrial fibrillation
* Off-label use of Eliquis

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: The incidence of all treatment-related adverse events ( AE)
timeFrame: 52 Weeks
measure: The incidence of serious adverse events (SAE)
timeFrame: 52 Weeks
measure: The incidence of unexpected treatment-related adverse events
timeFrame: 52 Weeks
measure: The incidence of bleeding
timeFrame: 52 Weeks
Secondary outcomes:
measure: The incidence of venous thromboembolism (VTE)
timeFrame: 52 Weeks
Other outcomes:
Locations:
city: Shinjuku-ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02430857: Osteopathy and Latent Hypothyroidism
Official title: Osteopathy and Latent Hypothyroidism: Effectiveness of Osteopathic Treatment on TSH in Patients With Latent Hypothyroidism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Latent Hypothyroidism
Lead sponsor: Diekmann, Emanuel Amier
Sponsor class: INDIV
First posted: 2015-04-30
Enrollment: 40
Sex: FEMALE
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: This study evaluates the effectiveness of stimulating the neurological segments c8-th5 in patients with latent hypothyroidism.

One half of the participants will receive an osteopathic manuel treatment in order to stimulate the relevant segments, the other half will receive no treatment.

Detailed description: Patients with latent hypothyroidism show an increased hormone status in TSH and a normal hormone status in fT4. A study has shown that osteopathic treatment had positive effects to some symptoms in patients with latent hypothyroidism. The study was using the pain inventory as the instrument to measure the effect. In this study we want to evaluate the effectiveness of the treatment on the hormone status (TSH, fT4) The intervention group will receive a neurological osteopathic stimulation over 5 weeks. A parallel control group will not receive any therapy.

A follow up blood screening (TSH, fT4) will be done. The results of both groups will be compared.

Eligibility criteria: Inclusion Criteria:

* latent hypothyroidism

Exclusion Criteria:

* Factors that Alter Thyroxine and Triiodothyronine Binding in Serum
* Increased thyroxin-binding globulin
* Decreased thyroxin-binding globulin
* Binding inhibitors
* Inherited Salicylates
* Pregnancy
* Androgens
* Furosemide
* Neonatal state
* Anabolic steroids
* Free fatty acids
* Estrogens
* Glucocorticoids
* Phenytoin
* Hepatitis
* Severe illness
* Carbamazepine
* Porphyria
* Hepatic failure
* nonsteroidal antiinflammatory drug (variable, transient)
* Heroin
* Nephrosis
* Heparin
* Methadone
* Nicotinic acid
* Mitotane L-Asparaginase
* 5-Fluorouracil
* SERMS (e.g., tamoxifen, raloxifene)
* Perphenazine
* spinal pathologies

Primary outcomes:
measure: Change in TSH Concentration
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Praxis fuer Osteopathy
name: Emanuel Diekmann, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02025257: Effects of Exercise in Patients With Coronary Artery Disease Aged 80 Years or Older
Official title: Effects of Exercise in Patients With Coronary Artery Disease Aged 80 Years or Older - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
elderly
exercise
exercise-based cardiac rehabilitation
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2014-01-01
Enrollment: 34
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of exercise for patients with coronary artery disease (CAD) aged 80 years and older, with special reference to maximum aerobic capacity, muscle endurance, physical functioning, level of physical activity, health related quality of life, anxiety, depression and endothelial function, compared to a control group.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute coronary artery disease
* Aged 80 years or older

Exclusion Criteria:

* Inability to understand or speak the Swedish language
* Serious physical or psychological disease interfering with participation in an exercise intervention
* Patients are already exercising three times or more/week

Primary outcomes:
measure: Change in maximum aerobic capacity
timeFrame: At baseline and after 4 months
Secondary outcomes:
measure: Change in level of physical activity
timeFrame: At baseline and after 4 months
measure: Change in muscular endurance
timeFrame: At baseline and after 4 months
measure: Change in physical functioning
timeFrame: At baseline and after 4 months
measure: Change in health related quality of life
timeFrame: At baselline and after 4 months
measure: Change in anxiety and depression
timeFrame: At baseline and after 4 months
measure: Change in endothelial function
timeFrame: At baseline and after 4 months
measure: Change in transthoracic evaluation of resting coronary flow velocity
timeFrame: At baseline and after 4 months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Department of physiotherapy, Sahlgrenska University Hospital
state: Select A State…
Study officials:
affiliation: Department of Physiotherapy, Sahlgrenska University Hospital, Gothenburg, Sweden
name: Maria Bäck, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden
name: Per Albertsson, PhD
role: STUDY_CHAIR
References:
citation: Brosved M, Hirlekar G, Philip Wigh J, Sundberg H, Ziden L, Karlsson T, Albertsson P, Back M. Effects of Cardiac Rehabilitation on Physical Fitness, Physical Function, and Self-reported Outcomes in Patients >/=80 yr: A RANDOMIZED CONTROLLED TRIAL. J Cardiopulm Rehabil Prev. 2022 Sep 1;42(5):331-337. doi: 10.1097/HCR.0000000000000683. Epub 2022 Mar 31.
Clinical trial NCT04422457: Specific Molecular Imaging of DX600 Labeled by PET Radionuclide Targeting ACE2 in Patients
Official title: Specific Molecular Imaging of DX600 Labeled by PET Radionuclide Targeting ACE2 in Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solid Tumor
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Angiotensin-converting enzyme 2 (ACE2) plays an important role in renin-angiotensin system (RAS) and has been reported to relate with cancer. Recently, it has also been proved as the key target for COVID-19 infection.

DX600 is a polypeptide that can specific binding to ACE2 specifically with nanomolar affinity reported in literature. This study constrcuted a radio-tracer, DX600 Labeled by PET Radionuclide, to monitoring biodistribution ACE2 in human beings, evaluate the detection ability of radio-tracer in ACE2 over-expression tumors and dynamic changes of ACE2 expression under therapy.


Eligibility criteria: Inclusion Criteria:

* Age 18-75 years old; both sex;
* ECoG 0 or 1;
* Patients that would undergo biopsy or surgical operation with high ACE2 expression tumors such as colorectal cancer, renal cancer, pancreatic cancer, gastric cancer, liver cancer, lung cancer, brain cancer or suspected tumor.
* use 18F-FDG PET/CT as baseline evaluation

Exclusion Criteria:

* Significant hepatic or renal dysfunction;
* Is Pregnant or ready to pregnant;
* Cannot lie on their back for half an hour;
* Suffering from claustrophobia or other mental diseases;
* Refusal to join the clinical study;

Primary outcomes:
measure: SUV
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Ethics Committee of Peking University Cancer Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03039426: Postoperative Cesarean Delivery Pain Relief; Diclofenac Versus Bupivacaine
Official title: A Randomized Comparison of Bupivacaine Peritoneal and Subcutaneous Infiltration Versus Diclofenac Intramuscular Injection for Postoperative Pain Relief in Patient Undergoing Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cesarean Delivery
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2017-02-01
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized controlled trial, compared postoperative pain score in patient undergoing cesarean delivery between bupivacaine peritoneal and subcutaneous infiltration and diclofenac intramuscular injection

Detailed description: Postoperative cesarean delivery was painful that can effect daily activity, resulted in poor quality of life and required morphine injection to relief pain which had both maternal and breastfeeding infancy side effect. So this study compare efficacy of diclofenac and bupivacaine by measured the pain score and requirement of morphine injection.

Eligibility criteria: Inclusion Criteria:

* Patients undergo elective or urgency cesarean delivery at Rajavithi Hospital in 2016-2017

  * Urgency conditions: CPD, fail induction of labor, antepartum hemorrhage without hypovolemic shock, dystocia, previous cesarean section and active labor, malpresentation in labor, macrosomic presentation in labor
* Pregnant women more than 20 years of age
* Gestational age more than 37 week
* Cesarean section under regional or general anesthesia
* Ability to communicating, writing and reading Thai language

Exclusion Criteria:

* Inability to communicating or writing or reading Thai language
* Contraindicated to bupivacaine or diclofenac or morphine
* Pregnant women with emergency conditions
* Have one or more complication of pregnancy
* Intraoperative arrhythmia
* Pregnant women less than 20 years of age
* Regional anesthesia with morphine

Primary outcomes:
measure: Compared pain score change from baseline at 2, 6 and 24 hours at post-operation between 2 groups by visual analogue scale
timeFrame: 2, 6 and 24 hours post-operation
measure: Compared rescued dose of morphine injection
timeFrame: Within 24 hours post-operation
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Natthida Mekwongtrakarn
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
References:
Clinical trial NCT03789526: Ultrasound-guided Intervention and Hand Tenosynovitis in Patients With Diabetes Mellitus
Official title: Ultrasound-guided Intervention and Hand Tenosynovitis in Patients With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasound Guided Injection
Keywords: Tenosynovitis
ultrasound
diabetes mellitus
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2018-12-28
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Group one: 26 patients DM patients with tenosynovitis were injected by triamcinolone under ultrasound guidance.
* Group two: 26 patients DM patients with tenosynovitis were injected by triamcinolone under clinical guidance.
Primary purpose: TREATMENT

Brief summary: Evaluates the efficacy of ultrasound guided versus clinically guided steroid injection in the management of tenosynovitis in DM patients.

Detailed description: The current study will based on follow up study, conducted among patients presenting at outpatient rheumatology clinics of Al-Azhar University Hospitals, Egypt. with Diabetes mellitus duration at least 3 years and tenosynovitis of hand tendons with Richie tenderness grade 3.

All patients will randomized in two groups: Group one: 26 patients DM patients with tenosynovitis were injected by triamcinolone under ultrasound guidance. Group two: 26 patients DM patients with tenosynovitis were injected by triamcinolone under clinical guidance.

The affected tendons will scanned and scored for inflammation using ultrasound in all patients before the triamcinolone injection and then to be reassessed one month after the injection to determine the change in the tendons in both groups.

Eligibility criteria: Inclusion Criteria:

* • Diabetes mellitus.

  * Disease duration 3 years or more.
  * Tenosynovitis of hand tendons with Richie tenderness grade 3.

Exclusion Criteria:

* • Patients with recent hand trauma.

  * Patients with inflammatory hand arthritis.
  * Previous tendon surgery.
  * Previous tendon injection.
  * Patients with contraindication for injection as related infection, uncontrolled DM or bleeding tendency.

Primary outcomes:
measure: change in Tenosynovitis pain
timeFrame: one month
measure: change in Tenosynovitis tenderness
timeFrame: one month
measure: changes in ultrasound images of the Tenoasynovitis.
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar university hospitals
Study officials:
References:
Clinical trial NCT00856726: Racial Differences in Phosphorus Metabolism
Official title: Racial Differences in Phosphorus Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Control
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2009-03-06
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators aim to study potential racial differences in renal phosphorus handling by provocatively testing urinary phosphorus excretion using parathyroid hormone infusions in healthy white volunteers compared to healthy black volunteers.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Body mass index (BMI) within 20% ideal for their age and gender

Exclusion Criteria:

* Abnormal urinalysis
* Pregnancy or breast-feeding
* Medical conditions impacting phosphorus metabolism-primary hyperparathyroidism; diabetes mellitus; gastrointestinal malabsorption disorders; hyper- or hypothyroidism
* Medications known to affect phosphorus metabolism- current use of phosphorus supplements, phosphorus binders, calcitriol or calcitriol analogues, regular antacid or laxative use, calcitonin, etidronate, anticonvulsants
* Hyper- or hypophosphatemia (≥ 4.6 mg/dl or ≤ 2.5 mg/dl respectively), hyper- or hypocalcemia (≥ 10.6 or ≤ 8.5 mg/dl respectively), or severe anemia (Hgb \< 8 g/dl for women and \< 9 g/dl for men)

Primary outcomes:
measure: Urinary Phosphorus Excretion
timeFrame: six hours
Secondary outcomes:
measure: Fibroblast Growth Factor 23
timeFrame: six hours
measure: Serum Phosphorus
timeFrame: six hours
measure: Serum Calcium
timeFrame: six hours
measure: Parathyroid Hormone
timeFrame: six hours
measure: Fractional Excretion of Calcium
timeFrame: six hours
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Orlando M Gutierrez, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gutierrez OM, Smith KT, Barchi-Chung A, Patel NM, Isakova T, Wolf M. (1-34) Parathyroid hormone infusion acutely lowers fibroblast growth factor 23 concentrations in adult volunteers. Clin J Am Soc Nephrol. 2012 Jan;7(1):139-45. doi: 10.2215/CJN.06240611.