louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02609412: Immediate Effects of Self-myofascial Release on Latent Trigger Point Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigger Points
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Latent myofascial trigger points (LMTRP) which impair neuromuscular performance occur in both, patients and asymptomatic subjects. As evidence suggests that LMTRP can transform into active trigger points, therapy seems warranted. Besides other modalities, self-massage using foam rollers (self-myofascial release) has been applied as a treatment. However, there is no data on the efficacy of this method concerning LMTRP. Thus, the present study aims to evaluate the effects of different forms of self-myofascial release on LMTRP pain.

Healthy patients with LMTRP in the calf are randomly allocated to one of three groups: 1) 90s static compression of the most sensitive LMTRP by means of the foam roll, 2) dynamic self-myofascial release rolling back and forth on the calf muscles for 90s using a foam roller, 3) placebo laser acupuncture of the most sensitive LMTRP. All subjects participate in a familiarization session with the foam roller one week prior to treatments. As an outcome, pressure pain threshold is assessed with an algometer. The investigators hypothesize, that static compression can reduce pressure pain of LMTRP more effective than dynamic self-myofascial release. The investigators further expect that placebo treatment will be the least effective method.


Eligibility criteria: Inclusion Criteria:

* at least one diagnosed latent myofascial trigger point in the calf
* age 18 to 65 years
* written informed consent

Exclusion Criteria:

* active myofascial trigger point in the calf
* regular intake of drugs or within past 48 hours
* severe psychiatric, neurological, orthopaedic, cardiovascular or endocrine diseases
* pregnancy or nursing period
* any condition that negatively influences current quality of life

Primary outcomes:
measure: Change in pressure pain threshold [kg/cm²] assessed by pressure algometer
timeFrame: Baseline (M1) - 3 minutes (M2)
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt/Main
country: Germany
facility: Goethe University Frankfurt/Main
Study officials:
affiliation: Department of Sports Medicine, Goethe University Frankfurt/Main
name: Winfried Banzer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00832312: Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee
Official title: Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis
Knee
Pain management
Ozone therapy
Intraarticular injection
Lead sponsor: Ben-Gurion University of the Negev
Sponsor class: OTHER
First posted: 2009-01-30
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether an intraarticular injection of Ozone into the knee joint is an effective therapy for pain control in patients with osteoarthritis of the knee.

Detailed description: Ozone, as a gas made of three atoms of oxygen with a cyclic structure, has been used as a medical therapy from the mid ninetieth century. Today, this therapy is a recognized modality in many European and Latin American nations for orthopedic problems, infections, ischemic diseases, and skin problems. However, despite of this wide use internationally, there is minimal mention of this treatment modality in the Anglo-American literature.

The present is the first of a series of studies planned to scientifically test the effectiveness of ozone as a main-stream therapy, introducing it to the Anglo-American literature. In this first study we will check whether intraarticular injections of Ozone into the knee joint are effective as a therapy for pain control in patients with osteoarthritis of the knee.

Eligibility criteria: Inclusion Criteria:

- Osteoarthritis of knee

Exclusion Criteria:

* Positive rheumatologic serologic tests
* Cognitive impairment
* Adjacent osteomyelitis
* Bacteremia
* Hemarthrosis
* Impending (scheduled within days) joint replacement surgery
* Infectious arthritis
* Joint prosthesis
* Osteochondral fracture
* Periarticular cellulitis
* Poorly controlled diabetes mellitus
* Uncontrolled bleeding disorder or coagulopathy.

Primary outcomes:
measure: Pain control
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Ben Gurion University
Study officials:
affiliation: Ben GurionUniversity
name: Howard B Tandeter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00485212: Compression Bandage in Local Infiltration Analgesia Afte Total Knee Arthroplasty
Official title: The Effect of a Compression Bandage in Local Infiltration Analgesia After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Knee Arthroplasty
Keywords: postoperative pain
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2007-06-12
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: purpose: to determine wether a compression bandage prolongs analgesia of local infiltration analgesia after total knee arthroplasty

Detailed description: patients are randomised to receive a compression bandage or a non-compression bandage

Eligibility criteria: Inclusion Criteria:

* scheduled for total knee arthroplasty
* speak and understand Danish

Exclusion Criteria:

* severe obesity
* allergies to local anaesthetics

Primary outcomes:
measure: pain, Visual Analogue Scale
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Lasse Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04421612: COVID-19 - No Health Without Mental Health
Official title: COVID-19 - No Health Without Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Anxiety
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group one recieve a new module every three days. Group two recive a new module every 5 days.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Corona pandemic is affecting the whole world and since March 12.th 2020 there has been strict qurantene and social isolation interventions in Norway. The aim of this intervention is to reduce the negative and fatal effects of the pandemic. The pandemic and the restrictions that follows it is assumed to affect the mental health of the general population. In this research project we want to examine the use and the effects of a digital self-guided psychological intervention with the aim to increase coping and to reduce psychological problems during and after the pandemic. The participants will be randomized to either an intensive group (new module every 3rd day) or to an ordinary group (new module every 5th day).

Detailed description: The intervention was developed in a crossdiciplinary and cross-sectorial team within the framework of the research project INTROMAT, an ICT Lighthouse research project funded by the Norwegian Research Council. The content of the digital covid-19 intervention was based on four previously developed digital interventions, all based on systematic user-involvement and user-testing, from our group. The person-based approach inspired the development of the intervention. Based on the research literature and experience from our existing digital interventions we started the development with establishing guiding principles. The intervention consists of 8 modules.

Eligibility criteria: Inclusion Criteria:

* read and write norwegian
* above 18 years
* Mild and moderate stress

Exclusion Criteria:

* current treatment for mental health disorders
* history or present severe mental health disorder

Primary outcomes:
measure: The Patient Health Questionnaire
timeFrame: 6 months
measure: The Generalized Anxiety Disorder Scale
timeFrame: 6 months
Secondary outcomes:
measure: Positive and negative affect
timeFrame: 6 months
measure: Perceived Stress Scale
timeFrame: 6 months
measure: Client Satisfaction Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
References:
Clinical trial NCT01659112: Effects of Core Stabilization Approach on Patients With Upper Extremity Injuries
Official title: Does Core Stabilization Enhance Neuromuscular Control and Functional Status of the Upper Extremity?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Extremity Injuries
Keywords: core stabilization, upper extremity, kinetic chain, movement
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2012-08-07
Enrollment: 27
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the effects of the addition of core stabilization exercises to a traditional upper extremity rehabilitation program in upper extremity injuries.

Detailed description: Abnormal movement patterns are one of the most challenging problems during rehabilitation of the patients with upper extremity injuries. They usually decrease the functional status of the upper extremity and prevent isolated muscle activations. Dysfunction of the kinetic chain system plays an important role in the development of these movement patterns. Thus, multi-segmental rehabilitation strategies has recently gained considerable importance in upper extremity rehabilitation. Core stabilization is one of the most popular rehabilitation approaches preferred to enhance functional stability of the kinetic chain system and dynamic postural alignment during activities. The purpose of this study is to determine the effects of core stabilization approach on functional status of the upper extremity and the amount of abnormal movement patterns. In addition, the factors affecting the abnormal movement patterns will be determined.

Eligibility criteria: Inclusion Criteria:

* Traumatic distal segment injuries (elbow and wrist)
* Patients in their subacute stage.

Exclusion Criteria:

* Multiple joint problems
* Bilateral extremity problems
* Reflex sympathetic dystrophy
* Trunk and lower extremity problems
* Non-union fractures
* Malignant ans systemic diseases

Primary outcomes:
measure: Upper extremity functional status
timeFrame: 30 minutes
Secondary outcomes:
measure: Measurement of abnormal movement patterns
timeFrame: 1 hour
Other outcomes:
measure: Trunk muscle strength
timeFrame: 5 minutes
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
Study officials:
affiliation: Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
name: Edibe Ünal, PhD, Prof
role: STUDY_DIRECTOR
References:
citation: Ayhan C, Unal E, Yakut Y. Core stabilisation reduces compensatory movement patterns in patients with injury to the arm: a randomized controlled trial. Clin Rehabil. 2014 Jan;28(1):36-47. doi: 10.1177/0269215513492443. Epub 2013 Jul 3.
Clinical trial NCT01150812: Oral AZD8165 After Single Oral Ascending Doses in Healthy Male Subjects
Official title: A Phase I, Single-center, Single-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD8165 After Single Oral Ascending Doses in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Thrombin Inhibition
Keywords: First time in man
healthy
thrombin inhibitor
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-06-25
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate the safety and tolerability of AZD8165 and the pharmacokinetics of the metabolite AZ12971554 and plasma levels of the prodrug AZD8165 after escalating single oral low doses.


Eligibility criteria: Inclusion Criteria:

* Suitable veins for cannulation or repeated venipuncture
* Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and nor more than 100 kg

Exclusion Criteria:

* History of any clinically significancy disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms.

Primary outcomes:
measure: Safety variables (adverse events, Electrocardiograms, vital signs, safety labs)
timeFrame: Approximately 64 days including a screening period, 3 treatment periods, 2 washout periods, and a follow-up period.
Secondary outcomes:
measure: Plasma and urine levels of AZD8165 and its active metabolite AZ12971554
timeFrame: Serial blood and urine samples will be taken over 24 hours after oral administration to evaluate AZD8165 and its active metabolite AZ12971554
measure: Coagulation times (namely Activated Partial Thromboplastin Time,Ecarin Clotting Time, Thrombin Clotting Time
timeFrame: Serial blood samples will be taken over 24 hours after oral administration to evaluate Activated Partial Thromboplastin Time (APTT), Ecarin clotting Time (ECT), Thrombin Clotting Time (TCT)
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
affiliation: Quintiles, Inc.
name: Ralph Schutz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Peter Held
role: STUDY_DIRECTOR
References:
Clinical trial NCT05322512: Nectin-4 Targeting ADC Probe for PET Imaging in Solid Tumors
Official title: Nectin-4 Targeting ADC Probe for PET Imaging in Solid Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Solid Tumor
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To study the normal physiological distribution of the probe 124I-EV in human body and its ability to detect overexpression of Nectin-4 in tumor lesions.

Detailed description: Nectin-4 is highly expressed in different types of cancer and is involved in various aspects of tumor proliferation, angiogenesis, metastasis, tumor recurrence, and DNA repair. Therefore, the development of nuclear medicine molecular probes targeting Nectin-4 is of great significance for improving the specificity and accuracy of Nectin-4 related cancer diagnosis.

EV (Enfortumab vedotin) is the first and only drug targeting Nectin-4 so far. By exploring the diagnostic efficacy of 124I-EV in tumors with high nectin-4 expression, it will not only provide evidence for the early diagnosis of tumors. At the same time, the Nectin-4 expression in tumors can be used to develop effective and precise treatment for patients.

Eligibility criteria: Inclusion Criteria:

1. 18-75 years old, male or female;
2. Patients recommended by clinicians to undergo PET/CT examination for tumor diagnostic staging;
3. The subject patients could fully understand and voluntarily participate in the experiment, and signed the informed consent.
4. Normal heart function;
5. Good follow-up compliance;
6. presence of at least one measurable target lesion according to RECIST1.1 criteria
7. Women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days before the start of the test; Fertile men and women must agree to use effective contraception to prevent pregnancy during the study period and for 3 months after the test.

Exclusion Criteria:

1. Serious abnormality of liver, kidney and blood;
2. Pregnant patients;
3. Pregnant and lactation women;

3) unable to lie flat for half an hour; 4) Refuse to join the clinical investigator; 5) Suffering from claustrophobia or other mental diseases; 6) Other conditions that researchers deem unsuitable for participating in the experiment.

Primary outcomes:
measure: SUV (Standardized Uptake Value)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00344812: Opioid Maintenance Medications Comparison Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid Dependence
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2006-06-27
Enrollment: 220
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A 17 week, double-blind, randomized, parallel group, four arm design outpatient study comparing LAAM, buprenorphine and two dose levels of methadone for the treatment of opioid dependence.


Eligibility criteria: Inclusion

* age 21 to 55 years
* diagnosis of opioid dependence by criteria of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
* evidence of recent opioid use on toxicologic screening

Exclusion

* serious medical or psychiatric illness requiring long-term medication
* positive pregnancy test

Primary outcomes:
measure: Study retention
measure: Drug use
Secondary outcomes:
measure: Safety
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Behavioral Pharmacology Research Unit; Johns Hopkins Bayview Campus
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Rolley E Johnson, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnson RE, Chutuape MA, Strain EC, Walsh SL, Stitzer ML, Bigelow GE. A comparison of levomethadyl acetate, buprenorphine, and methadone for opioid dependence. N Engl J Med. 2000 Nov 2;343(18):1290-7. doi: 10.1056/NEJM200011023431802.
Clinical trial NCT00907712: Cardiovascular Assessment Before and After Limb Amputation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diagnostic Techniques, Cardiovascular
Keywords: amputation
vascular
below knee
above knee
cardiovascular
echo
cardiovascular assessment
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2009-05-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Vascular lower limb amputees have an increased morbidity and mortality. The aim of the study is to evaluate the hemodynamic changes after amputation and its relation to outcome.


Eligibility criteria: Inclusion Criteria:

* all vascular or diabetic patients before leg amputation

Exclusion Criteria:

* traumatic amputation
* sepsis patient
* urgent surgery

Primary outcomes:
measure: cardiovascular assessment
timeFrame: week
Secondary outcomes:
measure: complications
timeFrame: month
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center
Study officials:
References:
citation: Izumi Y, Satterfield K, Lee S, Harkless LB. Risk of reamputation in diabetic patients stratified by limb and level of amputation: a 10-year observation. Diabetes Care. 2006 Mar;29(3):566-70. doi: 10.2337/diacare.29.03.06.dc05-1992.
citation: Izumi Y, Satterfield K, Lee S, Harkless LB, Lavery LA. Mortality of first-time amputees in diabetics: a 10-year observation. Diabetes Res Clin Pract. 2009 Jan;83(1):126-31. doi: 10.1016/j.diabres.2008.09.005. Epub 2008 Dec 20.
citation: Remes L, Isoaho R, Vahlberg T, Hiekkanen H, Korhonen K, Viitanen M, Rautava P. Major lower extremity amputation in elderly patients with peripheral arterial disease: incidence and survival rates. Aging Clin Exp Res. 2008 Oct;20(5):385-93. doi: 10.1007/BF03325142.
citation: Papazafiropoulou A, Tentolouris N, Soldatos RP, Liapis CD, Dounis E, Kostakis AG, Bastounis E, Katsilambros N. Mortality in diabetic and nondiabetic patients after amputations performed from 1996 to 2005 in a tertiary hospital population: a 3-year follow-up study. J Diabetes Complications. 2009 Jan-Feb;23(1):7-11. doi: 10.1016/j.jdiacomp.2007.11.008. Epub 2008 Apr 16.
Clinical trial NCT00688012: Safety Study of SPC3649 in Healthy Men
Official title: A Placebo-controlled, Double-blind, Randomized, Single Dose, Dose Escalating Trial in Healthy Men to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPC3649
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Keywords: antisense
microRna antagonist
anti-miR-122
Safety in healthy volunteers
Hepatitis C
Lead sponsor: Santaris Pharma A/S
Sponsor class: INDUSTRY
First posted: 2008-06-02
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: A placebo-controlled, double-blind, randomized, single dose, dose escalating trial in healthy men to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPC3649.


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers
* BMI: 19-28 kg/m2
* No clinically significant disease/disorder
* Screening laboratory tests without clinically significant abnormalities, must agree to use condoms during intercourse for one week after study drug infusion
* Following receipt of verbal and written information about the study, the subject must provide signed informed consent before any study related activity is carried out.

Exclusion Criteria:

* Heavy exercise within the past 7 days
* Alcohol intake\> 21 units weekly
* Regular smoker
* Received experimental drug within 30 days of study entry
* Planned participation in any experimental study during the study period
* HIV-Ab, HBsAg and/or HCV Ab positive
* History of specific allergy
* Current use of any drug or narcotics.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: PhaseOne Trials, Hvidovre University Hospital
Study officials:
References: