louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02455232: Determine the Main Muscle Participant in the Deformation of the Elbow in Hemiplegic Patients
Official title: Determine the Main Muscle Participant in the Deformation of the Elbow in Hemiplegic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2015-05-27
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: PREVENTION

Brief summary: The aim of this study is to determinate what are the main muscles regularly involved in the spastic pattern in flexion of the elbow using the selective motor nerve blocks of the elbow flexors. Three selective motor block nerves will be carry out in order to assess the gain of the range of motion (passive and active) of the elbow after each Motor Block Nerve.

Detailed description: To assess the impact of selective motor block nerves (successively brachialis motor branch, radialis motor nerve and musculocutaneous motor branch) on passive and active ranges of motion of the elbow in stroke patients with spastic flexion pattern.

Procedure: Following the morphological landmarks already described, the brachialis motor nerve of 30 patients was blocked with 4cc of lidocaïne® 1% (electro stimulation 0.8 to 1mA) (ref). Twenty minutes after the injection, the measurement of the degree of the spasticity, the passive angle in extension and the active range of motion in flexion of the elbow were performed. Then the radialis motor nerve block was performed (at the union of the median third and lower third of the arm, medial view, 3 finger widths above the medial epicondyle) using the same procedure, in order to block the brachioradialis and the brachialis in case of double innervation. Twenty minutes after the injection, the measurement of the passive and active ranges of motion of the elbow was performed. At the end the musculocutaneous motor block nerve was performed (proximal quarter of the arm, medial view, at the base of the inferior limit of the pectoralis major and along the biceps brachii tendon) in order to make the final difference with muscle contracture if it existed a doubt.

Eligibility criteria: Inclusion Criteria:

* written consent
* Hemiplegic patient with spasticity and deformation of elbow

Exclusion Criteria:

* pregnant woman

Primary outcomes:
measure: angles of elbow as measured by means of a goniometer
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Garches
country: France
facility: Hopital Raymond Poincaré
Study officials:
affiliation: Centre d'Investigation Clinique et Technologique 805
name: François Genet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06849232: A Comparative Study of Platelet-Rich Plasma and Normal Saline Dressings in the Treatment of Chronic Wounds (PRP-NS Wound T)
Official title: A COMPARATIVE STUDY of PLATELET-RICH PLASMA and NORMAL SALINE DRESSINGS in the TREATMENT of CHRONIC WOUNDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Healing
Lead sponsor: Quaid-e-Azam Medical College
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the effectiveness of Platelet-Rich Plasma (PRP) dressings versus Normal Saline dressings in the treatment of chronic wounds. Chronic wounds are slow-healing wounds that can cause significant discomfort, increase the risk of infections, and impact a patient's quality of life.

Platelet-Rich Plasma (PRP) is derived from the patient's own blood and contains growth factors that may help promote faster wound healing. On the other hand, Normal Saline dressings are commonly used as a standard wound care approach.

Participants in this study will be randomly assigned to receive either PRP dressings or normal saline dressings. The healing progress of their wounds will be monitored over a specified period to determine which treatment leads to better and faster healing.

The findings from this study may help improve wound care management and provide evidence for using PRP as an effective treatment for chronic wounds.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-60 years of either gender were included if they had a chronic wound persisting for at least six weeks and with a size of at least 2 × 2 cm.

Exclusion Criteria:

* Patients were excluded if their wounds had existed for less than six weeks, if they had a previous history of PRP dressing use, or if they had documented hypersensitivity to PRP.

Primary outcomes:
measure: Wound Healing Rate
timeFrame: April 17, 2024, to October 16, 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Bahawalpur
country: Pakistan
facility: Bahawal Victoria Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT00000332: High Dose Nimodipine Treatment Adjunct - 1
Official title: High Dose Nimodipine Pharmacotherapy Adjunct
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Washington D.C. Veterans Affairs Medical Center
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if nimodipine is more effective than placebo in reducing stimulated craving for cocaine in cocaine dependent individuals denied access to cocaine in inpatient unit.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Stimulated and non-stimulated craving
measure: Stimulated and non-stimulated withdrawal
measure: Anxiety, depression
measure: Heart rate
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington DC VA
state: District of Columbia
Study officials:
affiliation: Washington D.C. Veterans Affairs Medical Center
name: Steven Deutsch, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01616732: Testosterone and Weight Loss
Official title: Effect of Testosterone and Diet on Weight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity in Men
Lead sponsor: Austin Health
Sponsor class: OTHER_GOV
First posted: 2012-06-12
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesise that testosterone therapy will synergize with dietary intervention to achieve weight loss. Obese men will receive diet, and be randomised to either testosterone therapy or placebo. Primary outcomes will be weight and body composition.


Eligibility criteria: Inclusion Criteria:

* BMI \>30

Exclusion Criteria:

* contraindications to testosterone therapy

Primary outcomes:
measure: weight
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
Study officials:
References:
citation: Grossmann M, Fui MNT, Nie T, Hoermann R, Clarke MV, Cheung AS, Zajac JD, Davey RA. Changes in white adipose tissue gene expression in a randomized control trial of dieting obese men with lowered serum testosterone alone or in combination with testosterone treatment. Endocrine. 2021 Aug;73(2):463-471. doi: 10.1007/s12020-021-02722-0. Epub 2021 Apr 17.
citation: Ng Tang Fui M, Prendergast LA, Dupuis P, Raval M, Strauss BJ, Zajac JD, Grossmann M. Effects of testosterone treatment on body fat and lean mass in obese men on a hypocaloric diet: a randomised controlled trial. BMC Med. 2016 Oct 7;14(1):153. doi: 10.1186/s12916-016-0700-9.
Clinical trial NCT00702832: Effect of Vestibular Rehabilitation - a Randomized Controlled Trial
Official title: Effects of Vestibular Rehabilitation in the Treatment of Patients With Acute Vestibular Loss. - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dizziness
Nausea
Nystagmus
Vestibular Diseases
Keywords: Vestibular rehabilitation
acute vestibular injury
Dizziness
Nausea
Nystagmus
Daily life activities
Balance
physiotherapy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
name: St. Olavs Hospital
First posted: 2008-06-20
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 assess if early supported vestibular rehabilitation can reduce dizziness and improve daily life activities in patients with acute vestibular injury.

The study question is: Does early supported vestibular rehabilitation have an additional effect on dizziness symptoms and daily life functions compared to standard treatment?


Eligibility criteria: Inclusion Criteria:

* acute symptoms of dizziness, nausea and nystagmus
* diagnosed by videonystagmography (at least 25% reduced caloric response in one ear)
* age 18-70 years
* inclusion within one week after symptom debut

Exclusion Criteria:

* chronic dizziness
* psychiatric diagnosis that might interfere with participation

Primary outcomes:
measure: vertigo
timeFrame: at inclusion, 10-12 weeks, 12 months
Secondary outcomes:
measure: Dizziness
timeFrame: At inclusion, 10-12 weeks, 12 months
measure: Movement provoked dizziness
timeFrame: at inclusion, 10-12 weeks, 12 months
measure: return of symptoms
timeFrame: 12 months
measure: sick leave
timeFrame: 12 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: Associate professor / senior researcher
name: Siv Mørkved, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tokle G, Morkved S, Brathen G, Goplen FK, Salvesen O, Arnesen H, Holmeslet B, Nordahl SHG, Wilhelmsen KT. Efficacy of Vestibular Rehabilitation Following Acute Vestibular Neuritis: A Randomized Controlled Trial. Otol Neurotol. 2020 Jan;41(1):78-85. doi: 10.1097/MAO.0000000000002443.
Clinical trial NCT02102932: Bioavailability of Empagliflozin/Metformin Fixed Dose Combinations (FDCs) in Healthy Chinese Volunteers
Official title: Relative Bioavailability of Empagliflozin (12.5 or 5 mg)/Metformin (850 mg or 500 mg) Fixed Dose Combination Tablets Compared to Single Tablets Administered Together to Healthy Chinese Male and Female Volunteers in an Open-label, Randomised, Single-dose, Two-way Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2014-04-03
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the trial is to assess the relative bioavailability of fixed dose combination tablets of Empagliflozin and metformin compared to the administration of single tablets (Empagliflozin and metformin ) in Chinese subjects. The availability of a fixed dose combination tablet is expected to significantly enhance patient's compliance with antidiabetic treatment, in particular with concern to the frequent polypharmacy in diabetic patients.


Eligibility criteria: Inclusion criteria:

Healthy male and female subjects

Exclusion criteria:

Any relevant deviation from healthy conditions

Primary outcomes:
measure: AUC(0-∞) for Empagliflozin
timeFrame: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
measure: AUC(0-∞) for Metformin
timeFrame: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
measure: Cmax for Empagliflozin
timeFrame: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
measure: Cmax for Metformin
timeFrame: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Secondary outcomes:
measure: AUC(0-tz) of Empagliflozin
timeFrame: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
measure: AUC(0-tz) of Metformin
timeFrame: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Other outcomes:
Locations:
city: Beijing
country: China
facility: 1276.23.86002 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT00194532: Cefpodoxime vs Ciprofloxacin for Acute Cystitis
Official title: Cefpodoxime vs Ciprofloxacin for Acute Cystitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infection
Keywords: UTI
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Urinary tract infection (UTI) is a very common problem in young healthy women, afflicting approximately one-half of women by their late 20s. One of the most common antibiotics used to treat UTIs is ciprofloxacin, usually for a total of three days. However, increasing resistance to this antibiotic has raised concerns about its overuse for cystitis and generated interest in alternative agents. An alternative antibiotic which is approved for use in UTIs is cefpodoxime. However, there are few studies evaluating the efficacy and tolerance of this compound when given in a 3-day regimen as is commonly used for treatment of UTI. The major purpose of this study is to assess the efficacy and tolerance of a 3-day regimen of cefpodoxime versus ciprofloxacin for treatment of acute uncomplicated cystitis.

Detailed description: Procedures subjects will undergo once they have read and signed the consent are:

Questions about their medical and sexual history and current symptoms of UTI. They will be asked to provide a urine and peri-urethral sample and then are randomly assigned to one of the two treatment groups.They will be given a sheet to record symptoms at home. They will be asked to return to the clinic in 5-9 and 28-30 days after completing antibiotic therapy.Follow-up questions will be asked and urine and peri-urethral will be self collected at each visit.

Eligibility criteria: Inclusion Criteria:

* Nonpregnant females in good general health with symptoms of acute cystitis

Exclusion Criteria:

* Pregnant,lactating, or not regularly contracepting: known anatomic abnormalities of the urinary tract; use of prophylactic antibiotics; history of allergy or intolerance to any of the study drugs; recent (\>2 weeks)exposure to an oral or parenteral antimicrobial; or history of UTI in the previous 1 month

Primary outcomes:
measure: Clinical Cure
timeFrame: 28-30 days post therapy
Secondary outcomes:
measure: Microbiologic Cure
timeFrame: 1-15 days post therapy
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington, Department of Medicine
name: Ann Stapleton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hooton TM, Roberts PL, Stapleton AE. Cefpodoxime vs ciprofloxacin for short-course treatment of acute uncomplicated cystitis: a randomized trial. JAMA. 2012 Feb 8;307(6):583-9. doi: 10.1001/jama.2012.80.
Clinical trial NCT00982332: Efficacy of Micro-Pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica
Official title: Efficacy of Micro-pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polymyalgia Rheumatica
Keywords: polymyalgia rheumatica
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-09-23
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will examine the efficacy of a single intramuscular injection of betamethasone dipropionate/betamethasone sodium phosphate at the dose of 20mg/8mg (injection volume 4 ml) as an induction therapy in patients with polymyalgia rheumatica. Twenty patients will be randomized to receive an injection of betamethasone or placebo (isotonic NaCl solution) immediately after diagnosis. Both groups will receive the standard-of-care steroid therapy, starting from 10 mg of prednisone every day (qd), tapered down by 2.5 mg monthly if the disease is not active (scheduled monthly follow-ups by a rheumatologist). Primary outcome measures: the total cumulative dose of glucocorticosteroids and disease duration.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of polymyalgia rheumatica

Exclusion Criteria:

* decompensated diabetes mellitus
* decompensated arterial hypertension

Primary outcomes:
measure: a total dose of glucocorticoids used in the course of the disease
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
Study officials:
References:
Clinical trial NCT00551837: Immune Response to Influenza Vaccination
Official title: Immune Response to Influenza Vaccination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Solid Organ Transplantation
Chronic Kidney Disease
Keywords: Lung Transplantation
Kidney Transplnatation
Chroinic Kidney Disease
Influenza
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: University Hospitals Cleveland Medical Center
First posted: 2007-10-31
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lung and kidney transplant recipients, patients with chronic kidney disease and healthy controls

Brief summary: The purpose of this study is to evaluate the immune response to a routine influenza vaccination. Influenza vaccination is given as part of routine standard of care in these individuals and is not part of the study protocol. The study will evaluate for a change in response to common antigens over time after influenza vaccination to determine if changes are related to the development of chronic rejection after solid-organ transplantation. We hypothesize that the influenza vaccine contributes to the alloreactivity of T cells verses common HLA types in the donor pool.


Eligibility criteria: Inclusion Criteria:

* Transplant recipients (lung or kidney) 18 years or older, more than 3 months after transplantation
* Transplant candidates (kidney) 18 years or older, to recieve influenza vaccination
* Healthy volunteers to receive influenza vaccination

Exclusion Criteria:

* Under 18 years of age
* Pregnant
* Medical contraindication for vaccine
* Transplant recipients receiving acute rejection therapy within one month
* Healthy volunteers with autoimmune disease or medications to mediate immune function
* Receipt of live, attenuated influenza vaccine, instead of injectable vaccine

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Cleveland Clinic
name: Emilio Poggio, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04606537: Drug to Drug Interaction Study of KBP-5074 in Healthy Subjects
Official title: Phase 1, Open-label, Parallel, 2-arm, Fixed-sequence Study to Investigate the Effect of Coadministration of CYP3A4 Inhibitor and CYP3A4 Inducer on the Pharmacokinetics, Safety, and Tolerability of KBP-5074 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Drug Drug Interaction
Keywords: KBP5074
Healthy Subjects
itraconazole
rifampin
Lead sponsor: KBP Biosciences
Sponsor class: INDUSTRY
Collaborators: name: Covance
First posted: 2020-10-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Open-label, parallel, 2-arm, fixed-sequence study to investigate the effect of coadministration of a CYP3A4 inhibitor (Cohort 1, itraconazole multiple dose) and CYP3A4 inducer (Cohort 2, rifampin multiple dose) on the plasma PK of a single dose of KBP-5074 in healthy male and female subjects.


Eligibility criteria: Inclusion Criteria:

* Males or females, of any race, between 18 and 60 years of age, inclusive, at screening.
* Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening.
* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations

Exclusion Criteria:

* Significant history or clinical manifestation of any medical history, as determined by the investigator not appropriate to participate in this study.
* Use of any drugs or substances known to be strong or moderate inhibitors or inducers of CYP3A4 within 30 days prior to study drug administration. Medications will be reviewed by the medical monitor to determine acceptability for the study.

Primary outcomes:
measure: Pharmacokinetic Parameter: Maximum observed concentration (Cmax)
timeFrame: Days 1 and 19 at predose (Cohort 1) and Days 1 and 21 at predose (Cohort 2) and at 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 240 hours postdose.
measure: Pharmacokinetic Parameter: Area under the concentration-time curve from time 0 to infinity (AUC0-∞)
timeFrame: Days 1 and 19 at predose (Cohort 1) and Days 1 and 21 at predose (Cohort 2) and at 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 240 hours postdose.
measure: Pharmacokinetic Parameter: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast)
timeFrame: Days 1 and 19 at predose (Cohort 1) and Days 1 and 21 at predose (Cohort 2) and at 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 240 hours postdose.
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: QPS Missouri
state: Missouri
Study officials:
affiliation: KBP Biosciences
name: James McCabe
role: STUDY_DIRECTOR
References: