louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06009263: Effect of Open Chain Versus Closed Chain Segmental Control Exercises on CSA of Lumbar Multifidus Muscle in Chronic MLBP
Official title: Effect of Open Chain Versus Closed Chain Segmental Control Exercises on Cross Sectional Area of Lumbar Multifidus Muscle in Chronic Mechanical Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mechanical Low Back Pain
Keywords: Mechanical LBP
Cross Sectional Area
Multifidus muscle
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group will receive ultrasound and TENS as conventional treatment
Primary purpose: TREATMENT

Brief summary: To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on pain intensity, lumbar ROM, and CSA of multifidus muscle.

Detailed description: * To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on pain intensity.
* To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on lumber ROM.
* To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on CSA of multifidus muscle.
* To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on lumber function.

Eligibility criteria: Inclusion Criteria:

1. Patients with chronic low back pain from both genders their age will be ranged and divided into three groups from 25-55 years.
2. Participants with chronic low back pain lasting for more than 6 Months.
3. A patient who can follow the command.
4. A patient who can do exercise.

Exclusion Criteria:

1. Low back pain patients with a history of severe neurological disease or orthopedic disease.
2. History of Psychological Disorder.
3. Unhealthy Patient.
4. Pregnant women.
5. Patient with a spinal tumor.
6. History of any operation related to spine. Ex. Vertebral fracture or dislocation.

Primary outcomes:
measure: Cross sectional area of multifidus muscle
timeFrame: Pre and Post measurement (12 weeks)
measure: Pain intensity
timeFrame: Pre and Post measurement (12 weeks)
Secondary outcomes:
measure: ROM of lumbar spine
timeFrame: Pre and Post measurement (12 weeks)
measure: Functional ability of lumbar spine
timeFrame: Pre and Post measurement (12 weeks)
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
state: Dokki
Study officials:
affiliation: Cairo University
name: Haytham M Elhafez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00029263: Screening Herbs for Drug Interactions
Official title: R-21 Project: Screening Herbs for Drug Interference
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2002-01-10
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to detect potential herb-drug interactions in volunteers.

Detailed description: The use of herbal medicines in the treatment of various medical and psychiatric conditions has accelerated in the last decade. It has also become evident that herbal medications are being used concomitantly with conventional prescription and over-the-counter medications. However, the systematic evaluation of the potential of these agents to interact with conventional medications has been generally neglected. Compounding this problem is the fact that even single entity herbal products can contain a multitude of naturally occurring chemicals which serve as candidates for potential herb-drug interactions by inhibiting or inducing specific hepatic isozymes. Numerous reports document the importance of pharmacokinetic interactions involving inhibition or induction of the cytochrome P450 (CYP) enzyme system. In this study, the ten most commonly used herbal products in the US will be systematically evaluated for inhibition of CYP 3A4 and 2136, and induction of CYP 3A4. Collectively, these enzyme systems are involved in the metabolism of approximately 80% of all marketed medications.

Participants in this study will receive a single dose of the prescription drug alprazolam and the over-the-counter cough suppressant, dextromethorphan on two occasions. A combination of probe drugs will be given to normal volunteers both in the absence and presence of herbal medications. The plasma and urine concentration of these agents and their respective metabolites will be determined in order to evaluate individual herbal products degree and specificity of enzyme inhibitory or inductive effects.

Eligibility criteria: Inclusion Criteria:

* Normal healthy volunteers who are taking no medications.
* Must be non-smokers.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Institute of Psychiatry, Medical University of SC
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: John Markowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00237263: An Extension Study of Entacapone in Patients With Parkinson's Disease With End-of-dose Wearing-off. This Study is Not Recruiting in the United States
Official title: An Extension Study to Phase IIb Dose-finding Study of Entacapone in Patients With Parkinson's Disease With End-of-dose Wearing-off
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Parkinson's disease, end-of -dose wearing-off, entacapone
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 285
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of the long-term treatment of entacapone in patients with Parkinson's disease with end-of-dose wearing-off.

This study is not recruiting patients in the United States.

Detailed description: The purpose of this study is to evaluate the safety and efficacy of the long-term treatment of entacapone in patients with Parkinson's disease with end-of-dose wearing-off.

Eligibility criteria: Inclusion Criteria:

* Attended the Phase IIb study
* Able to fill out the patient diary

Exclusion Criteria:

* Serious heart, pulmonary, renal, hepatic or gastrointestinal disease
* Dementia symptoms
* Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Incidence of adverse events during the long term treatment (maximum 3 years)
measure: Blood pressure at every 12 weeks
measure: Laboratory test at every 16 weeks
measure: ECG at every 16 weeks
Secondary outcomes:
measure: On time based on patient diary (up to 104 weeks)
measure: UPDRS score at every 16 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
Clinical trial NCT06591663: Can Cognitive Therapy Rating Scale (CTRS) be Used Across Cultures? Enhancing Cultural Relevance of CTRS
Official title: Can Cognitive Therapy Rating Scale (CTRS) be Used Across Cultures? Enhancing Cultural Relevance of CTRS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Depression
Lead sponsor: Pakistan Association of Cognitive Therapists
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Translate and adapt the Cognitive Therapy Rating Scale (CTRS) into Urdu language and establishing the psychometric properties (reliability, validity, and norms) of the translated scale

Detailed description: The purpose of this study is to increase the accessibility and accuracy of clinical assessments, ultimately improving the quality of mental health care delivery and advancing research in the field of clinical psychology within Urdu-speaking communities

Eligibility criteria: Inclusion Criteria:

* Individuals aged 18 to 65 years At least 5 years of education Score of 8 or higher on Hospital Anxiety and Depression Scale-Depression or Anxiety scales as measured by their primary care clinician

Exclusion Criteria:

* Substance use disorder according to DSM-5 TR criteria Significant cognitive impairment (for example, profound learning disability or dementia) Active psychosis as determined by their primary care clinician

Primary outcomes:
measure: Establishing the psychometric properties of the translated CTRS scale
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Pakistan Association of Cognitive Therapists
state: Punjab
Study officials:
References:
Clinical trial NCT03335163: The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users
Official title: The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Migraine
Migraine;Menstrual
Contraception
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2017-11-07
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on serum ENG levels in contraceptive implant users
Primary purpose: TREATMENT

Brief summary: A prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on serum Etonogestrel (ENG) levels in contraceptive implant users.


Eligibility criteria: Inclusion Criteria:

* Healthy women, who have had an ENG implant for 12-36 months at the time of enrollment;
* Will maintain their implant during the study without modifications.

Exclusion Criteria:

* Women who are taking any medications or supplements known to be

  1. Cytochrome P-450 enzyme inducers, inhibitors, or substrates, and
  2. are not willing to abstain from any of these medications or supplements during the entire course of the study.
* Women with liver disease (i.e. hepatitis, fatty liver disease), and
* Women with abnormal liver or renal function, or
* Women with abnormal electrolytes on their screening blood work.

Primary outcomes:
measure: Serum Etonogestrel Concentrations
timeFrame: Enrollment (Baseline), 4 weeks (Visit 2), 5 weeks (Visit 3), 6 weeks (Visit 4)
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado School of Medicine
name: Stephanie Teal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lazorwitz A, Pena M, Sheeder J, Teal S. Effect of Topiramate on Serum Etonogestrel Concentrations Among Contraceptive Implant Users. Obstet Gynecol. 2022 Apr 1;139(4):579-587. doi: 10.1097/AOG.0000000000004697. Epub 2022 Mar 10.
Clinical trial NCT01864863: To Compare the Pharmacokinetics of Traclear 62.5 mg Tablets and HGP1206 125mg 1 Tablet in Healthy Male Volunteers
Official title: An Open-label, Randomized, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetics of Traclear 62.5 mg 2 Tablets and HGP1206 125mg 1 Tablet in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2013-05-30
Enrollment: 28
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the pharmacokinetics of two Traclear 62.5 mg tablets and one HGP1206 125 mg tablet in healthy male volunteers.

Detailed description: An Open-label, Randomized, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetics and safety of Traclear 62.5 mg Tablets and HGP1206 125mg Tablet in Healthy Male Volunteers.

Eligibility criteria: Inclusion Criteria:

* Healthy male
* Age between 20 and 55
* Signed informed consent

Exclusion Criteria:

* Has a history of Primary pulmonary hypertension to investigational product ingredients
* Hypotension or hypertension

Primary outcomes:
measure: AUClast
timeFrame: 0-24h
measure: Cmax
timeFrame: 0-24h
Secondary outcomes:
measure: Tmax
timeFrame: 0~24h
measure: AUCinf
timeFrame: 0~24h
measure: t1/2
timeFrame: 0~24h
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
affiliation: Samsung Medical Center
name: Wooseong Huh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03105063: Evaluation of the AIIS Using Hip Ultrasound(AIISUS)
Official title: Evaluation of the AIIS Using Hip Ultrasound(AIISUS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: AIS
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-04-07
Enrollment: 50
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 anatomy of the acetabulum is well described in the past literature, yet the understanding of the clinical importance of the anatomical morphology of the AIIS has grown in recent years. Hetsroni et al. (2013) proposed a morphological classification of AIIS. In this classification, three types AIIS are identified based on the relationship between the distal extension of the acetabular rim and the AIIS. Unfortunately classifying the morphology of the AIIS using standard AP pelvis examination is misleading and requires additional imagery, a specific radiographic projection - false profile pelvis or 3d imaging techniques such as CT or MRI.

The objective of this study is to evaluate AIIS morphology using ultrasound as compared to golden standard (MRI)


Eligibility criteria: Inclusion Criteria:

* adult patients (18 years and older) admitted to the TLVMC sports medicine outpatient clinic due to

hip related complaints

Exclusion Criteria:

* Patient refusal

  * Inability to consent
  * Unavailable 3d imaging the hip joint

Primary outcomes:
measure: AIIS morpholgy
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hapa O, Bedi A, Gursan O, Akar MS, Guvencer M, Havitcioglu H, Larson CM. Anatomic footprint of the direct head of the rectus femoris origin: cadaveric study and clinical series of hips after arthroscopic anterior inferior iliac spine/subspine decompression. Arthroscopy. 2013 Dec;29(12):1932-40. doi: 10.1016/j.arthro.2013.08.023. Epub 2013 Oct 18.
citation: Ryan JM, Harris JD, Graham WC, Virk SS, Ellis TJ. Origin of the direct and reflected head of the rectus femoris: an anatomic study. Arthroscopy. 2014 Jul;30(7):796-802. doi: 10.1016/j.arthro.2014.03.003. Epub 2014 May 2.
citation: Lee WA, Saroki AJ, Loken S, Trindade CA, Cram TR, Schindler BR, LaPrade RF, Philippon MJ. Radiographic Identification of Arthroscopically Relevant Acetabular Structures. Am J Sports Med. 2016 Jan;44(1):67-73. doi: 10.1177/0363546515612083. Epub 2015 Nov 20.
Clinical trial NCT00827463: Early Detection of Anaemia During the Maternity
Official title: The Early Detection of Anaemia During the Maternity Decreases the Anaemia at the End of the Maternity.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Keywords: aneamia
aneamia during the maternity
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Estimate the efficiency of a strategy of premature screening of the maternal anaemia during the first quarter of pregnancy versus the usual strategy of screening of the anaemia during the sixth month.

Detailed description: A part of the patient will have a NFS and dosage of the cast-iron, during the results of the beginning of the pregnancy at the first quarter.

The other part of the patients will have a NFS and at the first quater of the pregnancy.

All the patient will have a NFS at the results of the sixth month of the pregnancy.

A NFS will be done during the results at the end of the pregnancy like we do now.

Then a NFS at 48 hours after the birth. A treatment with iron will be done and according to the results

Eligibility criteria: Inclusion Criteria:

* Every patient followed at the HME at the beginnig of the pregnancy

Exclusion Criteria:

* pregnency women who don't speak french
* pregnancy women affected by béta thalassemia
* pregnancy woman having had a périconceptionnel treatment against the anaemia

Primary outcomes:
measure: primary outcomes: is the rate of heamophilia at the end of the pregnancy.
timeFrame: six months
Secondary outcomes:
measure: Secondary outcomes: - the percent of treatment of intravenous irons during the pregnancy and the following layers. - the percent of transfusion and the following layers.
timeFrame: 6 months
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU limoges
state: Limousin
Study officials:
affiliation: Limoges UH
name: Vincelot anne, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05372263: Safety Surveillance of Targeted Drugs for Pulmonary Hypertension Using a Computerized Follow-up System: a Nationwide Cohort Study
Official title: Safety Surveillance of Targeted Drugs for Pulmonary Hypertension Using a Computerized Follow-up System: a Nationwide Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Hypertension
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2022-05-12
Enrollment: 700
Sex: ALL
Minimum age (years): 3
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatients or inpatients with pulmonary hypertension

Brief summary: Recruit at least 700 PH patients, follow up every 6 months based on a computerized follow-up system. Primary outcomes are adverse drug events and all-cause death.


Eligibility criteria: Inclusion Criteria:

* Age from 3 months to 85 years, no sex preference;
* Right heart catheter meet the following conditions simultaneously: mPAP≥25mmHg, and PVR \> 3 Wood units(in children PVRi \> 3 WU x m2), and PAWP≤15 mmHg at rest;
* Patients diagnosed with group 1,2,4,5 PH according to the WHO classification, detailed description is as follows: Pulmonary arterial hypertension, Lung disease / chronic hypoxia associated pulmonary hypertension, Pulmonary hypertension associated with pulmonary artery stenosis / obstruction and Pulmonary hypertension caused by other multiple factors
* Take at least one pulmonary hypertension targeted drug or calcium antagonist;
* Signed written informed consent.

Exclusion Criteria:

* Patients diagnosed with pulmonary hypertension related to left heart disease;

Primary outcomes:
measure: Adverse drug events
timeFrame: through study completion, an average of 6 months
measure: All-cause Mortality
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Lu Hua, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00735735: Measurement of Substance P in Saliva of Low Back Pain Patients
Official title: Study of the Measurement of Substance P in the Saliva of Patients With Low Back Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
chronic
Substance P
Lead sponsor: Kovacs Foundation
Sponsor class: OTHER
First posted: 2008-08-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare the levels of Substance P in saliva, in patients with severe chronic low back pain and in subjects without it. In addition, to explore a possible cutoff point, in order to define normal and pathological levels of Substance P in saliva. The ultimate objective would be to design a measurement method for use in routine clinical practice.


Eligibility criteria: Inclusion Criteria:

* Patients referred to the Kovacs Back Pain Unit in Palma de Mallorca for chronic low back pain
* A pain level of 6 or greater on the PI-NRS scale (0=no pain, 10= worst pain possible)
* Seen at the Unit between 9 and 13 hours (due to the circadian rhythm of Substance P in saliva and to avoid great variability in the results)

For healthy subjects:

* Volunteers with no pain (anywhere)
* That in the past year have had no more than 40 days with pain, and no episode of more than 7 days of continuous pain.

Exclusion Criteria:

* Subjects with pain that is additional to or different from chronic low back pain

Primary outcomes:
measure: Levels of Substance P in the saliva
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Kovacs Foundation
state: Balearic Islands
Study officials:
affiliation: Kovacs Foundation, Palma de Mallorca, 07012, Spain
name: Francisco M Kovacs, MD, PhD
role: STUDY_DIRECTOR
affiliation: Kovacs Foundation,Palma de Mallorca, Spain
name: Mario Gestoso, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: LeVasseur SA, Gibson SJ, Helme RD. The measurement of capsaicin-sensitive sensory nerve fiber function in elderly patients with pain. Pain. 1990 Apr;41(1):19-25. doi: 10.1016/0304-3959(90)91104-Q.
citation: Morton CR, Hutchison WD. Release of sensory neuropeptides in the spinal cord: studies with calcitonin gene-related peptide and galanin. Neuroscience. 1989;31(3):807-15. doi: 10.1016/0306-4522(89)90443-0.
citation: Kowalski ML, Sliwinska-Kowalska M, Kaliner MA. Neurogenic inflammation, vascular permeability, and mast cells. II. Additional evidence indicating that mast cells are not involved in neurogenic inflammation. J Immunol. 1990 Aug 15;145(4):1214-21.
citation: Thomas KL, Andrews PV, Khalil Z, Helme RD. Substance P induced hydrolysis of inositol phospholipids in rat skin in an in vivo model of inflammation. Neuropeptides. 1989 Apr;13(3):191-6. doi: 10.1016/0143-4179(89)90091-7.