louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06231758: Metformin Safety and Efficacy in Osteoarthritis.
Official title: The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Osteo Arthritis Knee
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Knee osteoarthritis (OA) is a chronic, painful disease associated with considerable morbidity, costs and disability. It is estimated that over a third of people aged over 60 have radiographic knee OA2 and over 50% of these with knee OA will go on to have a total knee replacement in their lifetime. At present there are no licensed treatments that alter disease progress and management is primarily concerned with symptom control to retain or improve joint function, although a trial of strontium ranelate showed promising results.


Eligibility criteria: Inclusion Criteria:

* Primary osteoarthritis Patients recruited were between 30 to 60 years of age.
* X-ray confirmed Kellgren-Lawrence grade II or III severity primary tibiofemoral OA according to the American College of Rheumatology criteria.

Exclusion Criteria:

Patients with age less than 30 years or more than 60 years Patients Presented with active concomitant gastroduodenal disorders, hepatic and renal impairment within last 30 days prior to receiving the study drug Patients Were diagnosed to have any inflammatory arthritis, gout or acute trauma of the knee, hip or spine; accompanying OA of the hip of sufficient severity to interfere with the functional assessment of the knee Patients had previous or ongoing treatment with oral SYSDOA (e.g., glucosamine sulphate, chondroitin sulphate, diacerein, piascledine), anti-depressants, tranquillisers, antacids or antibiotics; were having active cardiac lesion or hypertension, were pregnant females and those who were planning their pregnancy during the study Patients having a known hypersensitivity to the used medications Patients have persistent diarrhoea or laxative use; severe gastrointestinal disorders, severe obesity, severe parenchymal organ disease, or anaemia (haemoglobin\< 10.0 g/ dl or haematocrit \< 30%).

Patients who received oral, intramuscular, intraarticular or soft tissue injections of corticosteroids within last eight weeks before receiving the first dose of the study medication or had undergone joint lavage and arthroscopic procedures in the previous 6 months, were also excluded.

Primary outcomes:
measure: The primary efficacy end point will be the change of Visual Analogue Scale (VAS) pain score from baseline to post treatment.
timeFrame: 3 months
Secondary outcomes:
measure: Secondary Outcome Measures will be the change of WOMAC Osteoarthritis Index from baseline to posttreatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Mostafa Bahaa
state: New Damietta
Study officials:
References:
Clinical trial NCT06836596: Efficacy of Sensory Electrical Stimulation Versus Alternating Electromyogram (EMG) On Functional Recovery Of Hand in Chronic Stroke Survivors :Randomized Controlled Trial
Official title: Efficacy of Sensory Electrical Stimulation Versus Alternating Electromyogram (EMG) On Functional Recovery Of Hand in Chronic Stroke Survivors :Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke Survivors
Chronic Stroke Survivors With Plegic Hand
Keywords: Sensory Electrical Stimulation - Alternating Electromyogram (EMG) - Functional Recovery - Hand - Chronic Stroke Survivors
Lead sponsor: Suez University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 45
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 aims to find out which treatment works better for improving hand function in stroke patients: sensory electrical stimulation or alternating electromyogram (EMG) stimulation. Both methods use electrical stimulation to help patients regain hand movement, but they work in slightly different ways. The goal is to see if one method is more effective than the other in helping stroke survivors recover their hand abilities.


Eligibility criteria: Inclusion Criteria:

* Chronic stroke patients were between 45 and 65 years old, with a duration of illness ranging from 6 to 18 months post-stroke. They exhibited upper extremity spasticity no greater than 1+ on the Modified Ashworth Scale. Patients were cooperative, as indicated by a Mini-Mental State Examination (MMSE) score of ≥ 24, and were capable of grasping and releasing at least one block in the Box and Block Test.

Exclusion Criteria:

* Hand function impairment caused by factors other than stroke, unstable health conditions such as cardiac dysfunction, end-stage renal failure, or uncontrolled diabetes, long-term use of medications that may affect motor or sensory excitability, contractures or restrictions in wrist joint range of motion, pre-existing musculoskeletal diseases significantly impacting physical function, and a history of Botulinum Toxin injection in the hand muscles.

Primary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: 12 weeks
measure: modified Ashworth scale
timeFrame: 12 weeks
measure: Medical Research Council scale for Fingers and Wrist
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy, Cairo universuty
Study officials:
References:
Clinical trial NCT03751696: Coaching Intervention in Women At-risk of Common Mental Disorders
Official title: Coaching Intervention to Improve Mental Well-being of Community Women Who Are At-risk of Common Mental Disorders in Hong Kong: A Pilot Randomized Controlled Trials
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Common Mental Disorder
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to provide preventative intervention to 60 women who are at risk of common mental disorders in Hong Kong.

Detailed description: Participants will be recruited through the following routes: 1) by our partner non-governmental organizations, 2) by our research team through community outreach or training activities, 3) online screening tool, and 4) referral from organizations that provide service to women (e.g., Maternal and Child Health Clinics of Department of Health). Eligible subjects with informed consent provided will be randomly assigned to coaching group or SMS self-help tips. To test the effectiveness of the provided intervention programs, symptoms assessments and data collection on demographics and psychosocial data will be carried out during baseline, immediately, and 3 months post-intervention.

Eligibility criteria: Inclusion Criteria:

* Willing to provide written informed consent
* Able to understand Cantonese and read/write Chinese
* With subsyndromal or minor depressive symptoms indicated by
* Depression subscale of Depression, Anxiety and Stress Scale (DASS) score 10-20 or
* Edinburgh Postnatal Depression Scale (EPDS) scores 10-13

Exclusion Criteria:

* A positive response in items about suicidal thoughts if applicable ("Yes, quite often" and "sometimes" in EPDS) (These participants will be referred to suicidal management)
* Those mental conditions that require other treatment priorities (e.g., suicidal risk, substance abuse, current or past episodes of psychotic disorder, personality disorders)
* Those medical conditions that severely limit participation, comprehension, or adherence to treatment (e.g., epilepsy, dementia, terminal medical illness)
* Those who are receiving structured psychotherapy or counseling

Primary outcomes:
measure: Depressive symptoms
timeFrame: immediate post-intervention
measure: Anxiety symptoms
timeFrame: immediate post-intervention
Secondary outcomes:
measure: Depressive symptoms
timeFrame: 3-month post intervention
measure: Anxiety symptoms
timeFrame: 3-month post intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Eric YH Chen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02529696: Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Official title: Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anesthesia
Keywords: accelerometer
RASS
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-08-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving care from the neuro ICU at the University of Minnesota will be eligible for participation.

Brief summary: Maintenance of analgesia during a patient stay in the hospital has been an important area of investigation after demonstrating a direct correlation between level of sedation and mortality in the ICU setting. This study will investigate the use of accelerometers in determining patient sedation level.

Detailed description: The goal of the study is to use accelerometers to track patient movement while under sedation in the ICU. Analysis of patient movement may reveal objective means to measuring patient level of sedation. Average length of stay is estimated to be one week.

Eligibility criteria: Inclusion Criteria:

* Admitted to the neuro ICU at University of Minnesota

Exclusion Criteria:

* Unable to wear accelerometer device

Primary outcomes:
measure: Accelerometer movement
timeFrame: Duration of ICU stay: estimated to be one week
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: David Darrow, MD/MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01821196: Density of Neurons in the Stomach and Prognosis of Gastric Adenocarcinoma
Official title: Density of Neurons in the Stomach and Prognosis of Gastric Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stomach Neoplasms
Keywords: Tumor Markers, Biological
PGP9.5 protein, human
adenocarcinoma
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
First posted: 2013-03-29
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Preclinical studies at our institution, based on a genetic mouse model of stomach cancer, strongly suggest that innervation of the stomach wall is deeply involved in tumorigenesis of stomach cancer. The data indicate that denervation of the stomach either by vagotomy or by injection of botulinum toxin (Botox®)in the stomach wall inhibits the development of cancer as well as reduces already established tumor volume in the stomach in this mouse model. Gene expression data indicate that vagotomy suppresses protein gene product 9.5 (PGP9.5). The expression of PGP9.5 is highly specific for the density of neurons and the diffuse neuroendocrine system. The investigators will take biopsies from tumors and adjacent normal mucosa either by means of endoscopy and/or from operative specimens from participants treated or evaluated for stomach cancer at the Department of Gastrointestinal Surgery, St Olavs Hospital, Trondheim University Hospital. The biopsies will be evaluated with immunohistochemistry and gene expression studies for the presence and density of PGP9.5. These data will be correlated to stage evaluation (TNM) and survival.


Eligibility criteria: Inclusion Criteria:

* Fifteen patients evaluated- or treated for suspected or verified gastric adenocarcinoma at the Department of Gastrointestinal Surgery, St Olavs Hospital, Trondheim University Hospital
* informed consent

Exclusion Criteria:

* General contraindications for endoscopy with biopsies (i.e. bleeding disorders or use of anticoagulants).

Primary outcomes:
measure: Density of PGP9.5 in gastric adenocarcinoma related to TNM stage and survival of stomach cancer
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: St. Olavs Hospital
name: Jon Erik Grønbech, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00060996: Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures
Official title: A Randomized Placebo-Controlled, 12-Week Multicenter Study of the Safety and Efficacy of Continuous or Daily Administration of Remodulin® (Treprostinil Sodium) Injection in Patients With CLI With No Planned Revascularization Procedures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Critical Limb Ischemia
Peripheral Vascular Disease
Foot Ulcers
Rest Leg Pain
Keywords: Critical Limb Ischemia
Peripheral Vascular Disease
UT-15
Remodulin
treprostinil
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2003-05-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess and compare the safety of continuous and daily subcutaneous Remodulin therapy in patients with critical limb ischemia (CLI) with no planned vascular interventional procedures; and to determine the effect of Remodulin on wound healing and treadmill walk distance.


Eligibility criteria: Patients with Stage III or IV critical limb ischemia due to documented peripheral arterial disease with no planned interventional vascular procedures

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida College of Medicine
state: Florida
city: Worcester
country: United States
facility: University of Massachusetts Memorial Health
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Philadelphia
country: United States
facility: Presbyterian Medical Center, Philadelphia Heart Institute
state: Pennsylvania
city: Columbia
country: United States
facility: South Carolina Heart Center
state: South Carolina
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
Study officials:
affiliation: United Therapeutics
name: Michael Wade, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01134796: Assessment of GRASP Medical Device to Improve Arm Coordination After Stroke
Official title: Assessment of GRASP II Medical Device to Improve Arm Coordination After Stroke
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Stroke
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2010-06-02
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke pateints and healthy volunteers (controls)

Brief summary: Assessment of a custom made grasp device in the rehabilitation of stroke victims.


Eligibility criteria: Inclusion Criteria:

1. Damage to the following areas of the brain, all of which may be involved in coordination of reach to grasp confirmed by CT scan: parietal, cerebellar, internal capsule and basal ganglia,
2. A score of 6 or more on the arm section of the Rivermead Motor Assessment (able to reach and pick up a tennis ball and release on thigh),
3. Time between start of hand opening and start of hand transport \> 60 ms (measured with GRASP).

Exclusion Criteria:

1. Cognitive dysfunction which prevents understanding of the task,
2. Severe concurrent medical problems that prevent repetitive reaching (including shoulder pain),
3. A diagnosis of Parkinson's disease, or
4. Lack of informed consent.

Primary outcomes:
measure: Time to grasp
timeFrame: 3 sessions
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Nottingham
name: Paulette Van Vliet
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01854996: Relative Bioavailability With PF-05089771 Capsule Versus Oral Dispersion
Official title: A Phase I, Randomized, Single-Dose Study To Determine The Relative Bioavailability Of Capsule Vs Oral Dispersion And The Effect Of Food On The Pharmacokinetics Of Orally Administered PF-05089771 As Capsule In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-05-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to test plasma exposure to PF-05089771 with same formulation will be used for phase II trials (capsule).


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests). Females must be of non-childbearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative, indicating that the subject has been informed of all pertinent aspects of the trial.
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal (i.e recurrent uric nephrolithiasis), endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy)

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: 48 hours
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 48 hours
Secondary outcomes:
measure: Number of Participants With Laboratory Test Values of Potential Clinical Importance
timeFrame: 48 hours
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03223896: Treatment of Gambling Disorder With Fast Acting Opiate Antagonist, Naloxone Nasal Spray
Official title: Pilot Study: Treatment of Gambling Disorder With Fast Acting Opiate Antagonist, Naloxone Nasal Spray
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gambling
Opioid
Naloxone
Spray
Keywords: antagonist
nasal
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
First posted: 2017-07-21
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A: max 8 mg/per day naloxone nasal spray

Group B: max 16 mg/per day naloxone nasal spray
Primary purpose: TREATMENT

Brief summary: Non-controlled pilot study. Two groups: Group A: naloxone nasal spray max 8 mg/per day; Group B: naloxone max 16 mg/per day. Study duration 8 weeks. Brief intervention.

Detailed description: Non-controlled pilot study. Two groups: Group A: naloxone nasal spray max 8 mg/per day; Group B: naloxone max 16 mg/per day. Study duration 8 weeks. No supportive therapy, but brief self-help booklet. Primary outcomes: adverse events, adherence and drop out analysis. Secondary outcome: gambling expenditure.

Eligibility criteria: Inclusion Criteria:

* age over 18 years old
* South Oaks Gambling Scale (SOGS) 5 or over points
* possibility to keep a record with phone and send text messages
* fluent in Finnish Language

Exclusion Criteria:

* active drug use (specially opioids) current use - drugs screen
* nasal abnormality or mucosal irritability
* hepatitis c virus, kidney insufficiency
* psychosis, unstable mental health, risk suicide (Beck Depression Inventory)
* pregnancy and/or breast feeding
* persons according to Finnish Medical Law 188/1999 §7-10

Primary outcomes:
measure: Adverse events
timeFrame: 8 weeks
measure: Adherence
timeFrame: 8 weeks
Secondary outcomes:
measure: Gambling expenditure
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: National Institute for Heath and Welfare
Study officials:
affiliation: Finnish Institute for Health and Welfare
name: Hannu Alho, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dowling N, Merkouris S, Lubman D, Thomas S, Bowden-Jones H, Cowlishaw S. Pharmacological interventions for the treatment of disordered and problem gambling. Cochrane Database Syst Rev. 2022 Sep 22;9(9):CD008936. doi: 10.1002/14651858.CD008936.pub2.
Clinical trial NCT00310596: Cardiovascular Safety Study of Magnevist® Injection at Two Dose Levels and Two Injection Rates in Normal Subjects
Official title: Cardiovascular Safety Study of 0.1 and 0.3 mmol/kg Magnevist® Injection at Two Injection Rates (Bolus and 10 mL/15 Sec.) in Normal Subjects Following a Randomized, Cross-over Design Using Placebo and a Concurrent Positive Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: ECG safety
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-04-04
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine what effect Magnevist (gadopentetate dimeglumine) injection has on the way the heart conducts the electrical impulses that allow it to beat effectively. The study will compare Magnevist injection's effect to that of placebo (a saline injection).

Detailed description: This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* Subjects with an electrocardiogram \[ECG\] (normal sinus rhythm \[SR\], QTc \> 450 msec) without clinically significant abnormalities
* Non-smoker

Exclusion Criteria:

* History of cardiovascular disease- Pregnant or nursing- Had any contraindication to moxifloxacin

Primary outcomes:
measure: The primary study variable was heart-rate corrected QT (QTc) interval
timeFrame: Within 15 min postinjection
Secondary outcomes:
measure: Adverse event monitoring, laboratory evaluations
timeFrame: 24 hrs postinjection
measure: ECG variables and overall interpretation
timeFrame: 24 hrs postinjection
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: