louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03258190: Lime Powder Regimen (LPR) for Prevention of Renal Stone Recurrence
Official title: Lime Powder Regimen Supplement Alleviates Urinary Metabolic Abnormalities to Prevent Urolithiasis Recurrence.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urolithiasis
Keywords: Urolithiasis
Recurrence
Citrate
Antioxidants
Lime Powder Regimen
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Sanpasitthiprasong Hospital
name: Burapha University
First posted: 2017-08-23
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: PREVENTION

Brief summary: Lime powder regimen (LPR) is a lime-derived composition enriches with citrate/citric acid and potassium. LPR was invented to treat the renal stone patients with high risk of stone recurrence after stone removal. LPR should have equal or higher efficacy and lower adverse effect than current standard medicine.

Detailed description: Lime powder regimen (LPR) is a mixture of lime-derive component with adjuvants containing high concentration of citrate, and moderate amount of potassium, magnesium and antioxidants. LPR was tested and verified to be very less toxic in cell culture and animal models. The clinical trial phase II showed that LPR reduced urinary metabolic abnormalities that enhance stone formation, such as hypocitraturia, hypokaliuria and acidified urine. Adverse effect of LPR was very low.

Eligibility criteria: Inclusion Criteria:

* Renal stone patients who were identified and stone was removed by surgical method.

Exclusion Criteria:

* Chronic kidney disease, chronic liver disease, history of coronary artery disease, or person who takes any medication that alters urinary metabolic profiles

Primary outcomes:
measure: Renal stone recurrence
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn University
Study officials:
References:
citation: Chariyavilaskul P, Poungpairoj P, Chaisawadi S, Boonla C, Dissayabutra T, Prapunwattana P, Tosukhowong P. In vitro anti-lithogenic activity of lime powder regimen (LPR) and the effect of LPR on urinary risk factors for kidney stone formation in healthy volunteers. Urolithiasis. 2015 Apr;43(2):125-34. doi: 10.1007/s00240-015-0751-y. Epub 2015 Jan 15.
Clinical trial NCT02626390: Information Provision During Early Gait Training Post Stroke
Official title: How do Different Styles of Information Provision Affect Learning During Early Gait Training Post Stroke? A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stroke
Lead sponsor: University of Southampton
Sponsor class: OTHER
First posted: 2015-12-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examined the feasibility of using implicit and explicit learning approaches during gait rehabilitation in the early phase following stroke. It was a double blind trial (participants and assessors) using a matched pairs design. Participants were recruited from an acute stroke unit, and were randomised to receive gait rehabilitation over three consecutive days using either an implicit or explicit approach. Guidelines for each were developed empirically, including differences in the amount, timing, and attentional focus of therapists' verbal communication. Sessions were recorded and their content analysed to establish concordance with the guidance. Clinical measures were taken at baseline and 24 hours post intervention using the Berg Balance Scale and the Step Test. Therapists were able to adhere to the guidance. Both approaches were found to be acceptable to both patients and therapists. The findings will be used to design an appropriately powered RCT.


Eligibility criteria: Inclusion Criteria:

* Patients receiving rehabilitation for their first episode of stroke which resulted in hemiplegia
* Able to give informed consent to take part in the study.
* Currently receiving physiotherapy for the re-education of gait (at minimum is able to stand, weight bear and take one step with assistance of one person).

Exclusion Criteria:

* Patients with a history of:

  * any other neurological conditions including previous stroke
  * any pre-stroke musculoskeletal condition that either: i. limited walking to less than 100 metres and/or ii. resulted in a noticeable gait abnormality and/or iii. required use of a bilateral walking aid (e.g. 2 walking sticks or a walking frame)
* Patients with marked receptive dysphasia (not able to follow 3-stage commands) - confirmed through liaison with multi-disciplinary team, including Speech and Language Therapists where necessary

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 24 hours post final treatment session
Secondary outcomes:
measure: Step Test
timeFrame: 24 hours post final treatment session
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01114490: Pharmacokinetics of Anacetrapib (MK0859) in Patients With Hepatic Insufficiency (MK-0859-039)
Official title: A Single Dose Study to Investigate the Pharmacokinetics of MK0859 in Patients With Hepatic Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemia
Keywords: Hepatic Insufficiency
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-05-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the Area Under the Curve (AUC(0 to infinity)) of anacetrapib.


Eligibility criteria: Inclusion Criteria:

* Female subjects of reproductive potential test negative for pregnancy and agree to use two acceptable methods of birth control throughout the study
* Subject is in good health
* Subject agrees to refrain from consumption of red wine, grapefruit, orange and apple juices throughout the study

Exclusion Criteria:

* Patient has a history of cancer
* Patient is a nursing mother
* Patient is unable to refrain from or anticipates the use of any prescription or non-prescription medication during the study
* Patient consumes excessive amounts of alcohol or caffeine
* Patient has had major surgery, donated blood or participated in another investigational study within the past 4 weeks

Primary outcomes:
measure: Area Under the Curve (AUC(0 to infinity)) of anacetrapib
timeFrame: through 168 hours post dose
Secondary outcomes:
measure: Tolerability of a single dose administration of 100mg anacetrapib, measured by the number of clinical and laboratory adverse events
timeFrame: through 14 days post dose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Lauring B, Li XS, Liu Y, Corr C, Lazarus N, Cote J, Larson P, Levonas AO, Lasseter KC, Preston RA, Smith WB, Lai E, Wagner JA. Influence of renal and hepatic impairment on the pharmacokinetics of anacetrapib. J Clin Pharmacol. 2014 Nov;54(11):1247-55. doi: 10.1002/jcph.320. Epub 2014 Jun 6.
Clinical trial NCT05435690: Evaluation of a New Navigation System in Computer-assisted Total Knee Arthroplasty
Official title: Evaluation of a New Navigation System in Computer-assisted Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gonarthrosis
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind, randomised, prospective comparative study in two parallel groups (conventional or computer-assisted arthroplasty).
Primary purpose: TREATMENT

Brief summary: Evaluation of a new navigation system in computer-assisted total knee arthroplasty.

Detailed description: Single-blind, randomised, prospective comparative study in two parallel groups (conventional or computer-assisted arthroplasty).

The patient will be evaluated during 3 visits: inclusion D0 (before arthroplasty), M3 (intermediate visit 3 months after arthroplasty) and M12 (final visit 12 months after arthroplasty).

Eligibility criteria: Inclusion Criteria:

* Adult man or woman who has signed the informed consent for participation in the study,
* Patient with primary uni or bilateral gonarthrosis
* For whom an indication for total knee arthroplasty has been given

Exclusion Criteria:

* History of fracture, arthroplasty or osteotomy of the knee
* Severe preoperative laxity warranting a constrained prosthesis
* Inflammatory rheumatic disease or any other progressive concomitant condition that may impact on the patient's functional prognosis
* Traumatic articular or extra-articular deformities of the lower limb
* Neurological disease, after-effects of a stroke
* Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol
* Patient not affiliated to the French social security system
* Patient under legal protection, guardianship or curatorship
* Patient already included in another therapeutic study protocol or having participated in another trial in the previous three months

Primary outcomes:
measure: KSS M12
timeFrame: Month 12
Secondary outcomes:
measure: KSS M3
timeFrame: Month 3
measure: KOOS JR M3
timeFrame: Month 3
measure: KOOS JR M12
timeFrame: Month 12
measure: EQ-5D M3
timeFrame: Month 3
measure: EQ-5D M12
timeFrame: Month 12
measure: FJS M3
timeFrame: Month 3
measure: FJS M312
timeFrame: Month 12
measure: Surgery duration
timeFrame: Day 0
measure: Hospitalization duration
timeFrame: Month 1
measure: Lower limb alignment
timeFrame: Month 12
measure: Postoperative outcome predictive factor
timeFrame: Month 1
measure: Safety analysis
timeFrame: Month 12
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Privé Jean Mermoz
Study officials:
References:
Clinical trial NCT05729490: Techniques and Pitfalls of Multi-Slice CT Coronary Angiography
Official title: Techniques and Pitfalls of Multi-Slice CT Coronary Angiography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Computed Tomography Angiography
Coronary Artery Disease
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this study is to describe the techniques for coronary multi-slice CT angiography and to illustrate the spectrum of artifacts that can simulate coronary artery stenosis and lead to non-assessable segments using 128- and 160 multi-detector row CT scanners and discuss post-processing pitfalls with each. In addition, to review the normal anatomy and anatomic variants of the coronary arteries and discuss effective strategies for improving the diagnostic accuracy of coronary CT angiography.


Eligibility criteria: Inclusion Criteria:

* Male and female patients of at least 18 years of age, with suspected symptomatic CAD.

Exclusion Criteria:

* Un cooperative patients.
* Those who have allergy to iodinated contrast material or contrast-induced nephropathy,
* Elevated serum creatinine level (1.5 mg/dl) or creatinine clearance \>60 ml/min.
* Atrial fibrillation.
* Aortic stenosis.
* Percutaneous coronary intervention within the past 6 months.
* Intolerance to beta-blockers.
* Body mass index \> 40
* Patients with Agatston calcium scores of \>400

Primary outcomes:
measure: Number of techniques
timeFrame: 2 months
measure: Number of pitfalls
timeFrame: 3 months
measure: Number of possible strategies to overcome the pitfalls of the study
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University hospitals
Study officials:
References:
citation: Maroules CD, Rajiah P, Bhasin M, Abbara S. Current Evidence in Cardiothoracic Imaging: Growing Evidence for Coronary Computed Tomography Angiography as a First-line Test in Stable Chest Pain. J Thorac Imaging. 2019 Jan;34(1):4-11. doi: 10.1097/RTI.0000000000000357.
citation: Tridandapani S, Banait-Deshmane S, Aziz MU, Bhatti P, Singh SP. Coronary computed tomographic angiography: A review of the techniques, protocols, pitfalls, and radiation dose. J Med Imaging Radiat Sci. 2021 Nov;52(3S):S1-S11. doi: 10.1016/j.jmir.2021.08.014. Epub 2021 Sep 24.
citation: Sun Z, Choo GH, Ng KH. Coronary CT angiography: current status and continuing challenges. Br J Radiol. 2012 May;85(1013):495-510. doi: 10.1259/bjr/15296170. Epub 2012 Jan 17.
citation: Donnino R, Jacobs JE, Doshi JV, Hecht EM, Kim DC, Babb JS, Srichai MB. Dual-source versus single-source cardiac CT angiography: comparison of diagnostic image quality. AJR Am J Roentgenol. 2009 Apr;192(4):1051-6. doi: 10.2214/AJR.08.1198.
Clinical trial NCT03394690: Effects of Green Coffee Extract Supplementation on Leptin, Ghrelin, Adiponectin,Anthropometric Measurements, Lipid Profile in Breast Cancer Survivors
Official title: the Evaluation of Green Coffee Extract Supplementation on Leptin, Ghrelin, Adiponectin,Anthropometric Measurements, Lipid Profile in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer Survivors
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2018-01-09
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effects of green coffee supplement on leptin, adiponectin, ghrelin, anthropometric measurements, lipid profile in breast cancer survivors.50 breast cancer survivors who their treatment is over and referred to follow breast cancer clinic with will be randomly allocated to receive placebos or 2 capsules green coffe for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, leptin, adiponectin, ghrelin, anthropometric measurements, lipid profile will be assessed and compared between groups.


Eligibility criteria: Inclusion Criteria:

* Age of 18 to 70 years
* Body Mass Index (BMI) between 25-40 treatment is over

Exclusion Criteria:

* -Taking any kind of supplement for weight reduction
* pregnancy or lactation
* Professional athletes

Primary outcomes:
measure: gherlin
timeFrame: 12 weeks
measure: Adiponectin
timeFrame: 12 weeks
measure: Leptin
timeFrame: 12 weeks
Secondary outcomes:
measure: body mass index
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: National Nutrition and Food Technology Research Institute
Study officials:
References:
Clinical trial NCT06437990: Arteriovenous Loop Graft for Free Functional Gracilis Transfer in Brachial Plexus Surgery
Official title: Pilot Study of Arteriovenous Loop Graft for Free Functional Gracilis Transfer in Brachial Plexus Injured Patients With Insufficient Flow of Donor Artery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Brachial Plexus Injury
Keywords: brachial plexus injury
brachial plexus palsy
free functional muscle transfer
arteriovenous loop graft
subclavian artery injury
axillary artery injury
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Late-onset brachial plexus injury patient with concomitant subclavian or axillary artery injury
Primary purpose: TREATMENT

Brief summary: Free functional muscle transfer (FFMT) using the gracilis muscle as a donor muscle has become a standard treatment for reconstructing late-onset brachial plexus injuries. Successful implementation of this procedure relies on the availability of functional donor vessels in the injured limb to supply the muscle flap. However, some brachial plexus injuries are accompanied by subclavian or axillary artery injuries, which compromise the viability of the muscle flap due to insufficient vascular supply. To address this, arteriovenous (AV) loop grafts have been employed to extend donor vessels to the flap and have been utilized in various body regions, including the upper extremity. Despite their widespread use, AV loop grafts have not been previously utilized in FFMT for late-onset brachial plexus injuries with concurrent subclavian or axillary artery injuries. This study aimed to assess the feasibility of this surgical approach and report the long-term outcomes of the procedure.


Eligibility criteria: Inclusion Criteria:

* Age equal or more than 20 years old
* Patients with brachial plexus injury with depletion of blood flow to the injured limb which confirmed by abnormal computed tomography arteriogram

Exclusion Criteria:

* Patients who had sufficient thoraco-acromial or thoraco-dorsal artery blood flow for standard free functional muscle transfer operation without the need of an AV loop graft

Primary outcomes:
measure: Viability of the flap
timeFrame: 1 month
Secondary outcomes:
measure: Motor power
timeFrame: 12 months, 18 months
measure: Complications
timeFrame: 1 month
measure: Operative time
timeFrame: 1 month
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Siriraj Hospital
name: Panai Laohaprasitiporn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02684890: Detection of Emotions in a Spoken Language Among Tinnitus Patients
Official title: Detection of Emotions in a Spoken Language Among Tinnitus Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tinnitus
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-02-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with tinnitus

Brief summary: Tinnitus may affect the ability of patients to detect emotions in spoken language. This study will compare this ability between tinnitus patients and non-tinnitus patients.


Eligibility criteria: Inclusion Criteria:

* Tinnitus lasting 3 months and longer
* Hebrew speakers

Exclusion Criteria:

* Tinnitus which began less than 3 months ago Learned Hebrew after the age of 5

Primary outcomes:
measure: Emotion scores
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson Medical Centre
Study officials:
References:
Clinical trial NCT01094990: Efficacy of Dexamethasone for Prevent Vomiting in Leukemic Children Who Receive Intrathecal Chemotherapy
Official title: Efficacy of Dexamethasone for The Prevention of Nausea and Vomiting Associated With Intrathecal Chemotherapy and Ketamine Sedation in Children With Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Leukemic Patients in Children
Keywords: crossover; double blinded; intrathecal chemotherapy; dexamethasone; ketamine;vomiting
Lead sponsor: Phramongkutklao College of Medicine and Hospital
Sponsor class: OTHER
First posted: 2010-03-29
Enrollment: 32
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Null hypothesis The proportions of vomiting are not different between dexamethasone and placebo in the patient after sedation with intravenous ketamine and lumbar puncture with intrathecal chemotherapy Alternative hypothesis The proportions of vomiting are different between dexamethasone and placebo in the patient after sedation with intravenous ketamine and lumbar puncture with intrathecal chemotherapy

Detailed description: Does intravenous dexamethasone 0.25 mg/kg (8 mg/m2/dose) have an effect in the reduction of vomiting and retching after sedation with intravenous ketamine and lumbar puncture with intrathecal chemotherapy comparison with placebo?

Eligibility criteria: Inclusion Criteria:

* Patients aged between 2-15 years who underlying acute lymphoid or nonlymphoid leukemia and need to receive ketamine and intrathecal chemotherapy.
* Personally signed and dated informed consent and assent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to study entry.

Exclusion Criteria:

* Patients who had a known allergy to ketamine or dexamethasone.
* Patients who had contraindication for ketamine or dexemethasone such as hypertension, increased intracranial pressure or central nervous system mass lesion, major psychiatric , and hyperglycemia.
* Patients who concurrent with nausea and vomiting during that time.
* Patients who received ondansetron or other antiemetic before doing Procedure.
* Patients who received other chemotherapy before or after 24 hours.

Primary outcomes:
measure: : To determine whether vomiting and retching associated with intravenous ketamine and intrathecal chemotherapy may be reduced by the addition of prophylactic dexamethasone
timeFrame: 24 hours
Secondary outcomes:
measure: To determine whether severity of the nausea after procedure may be reduced by the addition of prophylactic dexamethasone.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Phramongkutklao hospital
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
Study officials:
affiliation: Phramongkutklao College of Medicine and Hospital
name: chanchai traivaree, MD
role: PRINCIPAL_INVESTIGATOR
References: