louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00660192: Investigation of Efficacy and Safety of Botulinum Toxin A (Botox-Allergan Inc) in Migraine Headaches
Official title: Investigation of Efficacy and Safety of Botulinum Toxin A (Botox-Allergan Inc) in Migraine Headaches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Refractory Migraine
Keywords: Migraine, refractory migraine, Pain, Botulinum Toxin , Botox
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2008-04-17
Enrollment: 25
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: The hypothesis of this study is that injection of botulinum toxin A into the muscles around the head (frontal, temporal, posterior neck, occipital) can reduce the intensity and frequency of migraine headaches by 50%.

Detailed description: Contact PI for study details

Eligibility criteria: Inclusion Criteria:

* Adults 18 and older
* Migraine for more than three months, that fail to respond to two or more major anti-migraine drug, meeting criteria of chronic migraine

Exclusion Criteria:

* Age below 18
* Pregnant or may become pregnant
* Disease of neuromuscular junction or drugs that affect N-M junction
* Allergy to Botox
* Previous use of Botox for migraine by similar methodology

Primary outcomes:
measure: Mean Number of Days of Decrease in Pain Level Using VAS
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of Participants Satisfied With Treatment
timeFrame: 4 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Physician's Building, 800 Howard Ave, lower level,
state: Connecticut
Study officials:
affiliation: Yale- 203-737-2464
name: Bahman Jabbari, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02903992: SArcopenia Prevalence in Frail Older Adults. SAF Study
Official title: SArcopenia Prevalence in Frail Older Adults: SAF Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Frail Elderly
sarcopenia
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 225
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The age-associated loss of lean mass is a defining parameter of sarcopenia and may lead to various negative health outcomes such as impairment of physical performance and disability. Furthermore sarcopenia is considered to be one of the main factors in the pathogenesis of the frailty syndrome. However, for clinical use and for treatment and prevention strategies, reliable diagnostic criteria and cutpoints based on clinically relevant thresholds are indispensable.

This topic has recently been addressed by the Foundation for the National Institutes of Health Sarcopenia Project which identified cutpoints for appendicular lean mass (ALM) below which older adults had a higher likelihood of clinically relevant weakness reflected by low grip strength. Moreover, a low ALM-to-body mass index (BMI) ratio (\<0.789 men and \<0.512 women) was found to be associated with increased likelihood for mobility impairment.

In this context, the aim of this study is to study the prevalence of sarcopenia in a sample of community-dwelling frail and pre-frail older adults.


Eligibility criteria: Inclusion Criteria:

* Aged 70 years and over,
* Living independently (ADL score ≥ 5/6),
* Fail or pre-frail according to Fried criteria,
* Informed written consent,
* Subjects affiliated to a social security.

Exclusion Criteria:

* Robusts patients (no Fried criteria),
* Other disorders that could interfere with the interpretation of the study (like visual or hearing impairments),
* Subjects under justice protection,
* Participation in another study at the same time.

Primary outcomes:
measure: Sarcopenia Diagnostic with Dual-energy X-ray absorptiometry
timeFrame: one day (participation of subject)
Secondary outcomes:
measure: (SPPB) score
timeFrame: one day (participation of subject)
measure: (MMSE) score
timeFrame: one day (participation of subject)
measure: (MNA) score
timeFrame: one day (participation of subject)
measure: (IADL) score
timeFrame: one day (participation of subject)
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Toulouse University Hospital (CHU de Toulouse)
Study officials:
affiliation: oulouse University Hospital (CHU de Toulouse)
name: Bertrand FOUGERE, MD, Ph D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03366792: Comparative Analysis of Transperineal Versus Transrectal Approaches for MRI-Targeted Biopsy of the Prostate for the Detection and Characterization of Prostate Cancer
Official title: Comparative Analysis of Transperineal Versus Transrectal Approaches for MRI-Targeted Biopsy of the Prostate for the Detection and Characterization of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 46
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to investigate a transperineal biopsy approach (outside of the rectum) using MRI targeting to facilitate better access to the whole prostate gland and provide limited risk of infectious complications after biopsy.

Detailed description: Prostate cancer is the most common malignancy and the second most common cause of cancer death in men in the Western hemisphere. Definitive diagnosis of prostate cancer relies on biopsy of the prostate gland, which is historically performed by taking 12 random biopsies of the prostate by placing a needle through the rectum under ultrasound guidance. Recently, advances in MRI techniques have allowed identification of suspicious lesions within the prostate prior to biopsy, which has given rise to targeting biopsy cores to high-suspicion areas using fused ultrasound-MRI images. However, the most commonly used transrectal approach to biopsy is associated with a growing rate of infectious complications as well as poor sampling of the anterior region of the prostate, which is furthest from the rectum.

Eligibility criteria: Inclusion Criteria:

* No contraindication to prostate biopsy (e.g. coagulopathy, medical condition prohibiting abstinence from anti-platelet or anticoagulation therapies, anatomical considerations) Area of suspicion or known cancer focus on previously obtained mpMRI of the prostate (at least one lesion with MRI suspicion score \>3/5)

Exclusion Criteria:

* Prior pelvic radiotherapy
* Evidence of urinary tract infection or significant urinary retention
* Prostate instrumentation (e.g. prostate biopsy, transurethral prostate procedure) within 2 months prior to mpMRI
* No evidence of suspicious lesions on mpMRI
* Irreversible coagulopathy
* Contraindication to sedation

Primary outcomes:
measure: Core Cancer Length
timeFrame: 2 Months
Secondary outcomes:
measure: Percentage of High-Grade Prostate Cancer Using Gleason Score
timeFrame: 2 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Samir Taneja, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05568992: Prospective, Randomized Controlled Study to Evaluate the Effect of Artificial Intelligence Assisted Optical Diagnosis of Advanced Adenomas
Official title: Prospective, Randomized Controlled Study to Evaluate the Effect of Artificial Intelligence Assisted Optical Diagnosis of Advanced Adenomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Adenoma
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study is a clinical validation of our developed a computer-aided optical dignosis of advanced adenoma using non-magnified NBI image. This study is a randomized clinical trial comparing endoscopists' optical recognition of advanced adenoma for sending to histological examination with our computer-aided system. The hypothesis of the study is that the developed computer-aided system increases the percent of sending actual advanced adenoma Intelligence Assisted Optical Diagnosis of Advanced Adenomas

Detailed description: Colorectal polyp diagnosis is based on endoscopic resection and histological analysis. An accurate optical diagnosis could avoid histological lesion of smaller lesions, reducing the costs associated with histological diagnosis. However, it should be noted this policy could only be applied in diminutive polys considering high proposition of advanced adenomas in polyps more than 5 mm. In addition, optical diagnosis criteria of advanced adenomas have not been validated for finding advanced adenomas among adenoma polyps. If as many as advanced adenomas as possible could be differentiated from non-advanced adenomas and be further sent for histological examination, this policy could be generalized to small polyps.

Considering this situation, the investigators tried to develop computer-aided optical dignosis of advanced adenoma using non-magnified NBI image with preliminary, satisfied results. In this study, the investigators next validate the investigators' developed computer-aided system for detecting advanced adenomas by comparing endoscopists' optical detection of advanced adenomas with or without the investigators' computer-aided system.

Eligibility criteria: Inclusion Criteria:

* Endoscopists with NBI experience

Exclusion Criteria:

* Endoscopists without colonoscopy and NBI experience

Primary outcomes:
measure: Proportion of advanced adenomas for sending to histological examination
timeFrame: 1 day
Secondary outcomes:
measure: Optical diagnostic accuracy of non-advanced adenomas under high confidence
timeFrame: 1 day
measure: Proportion of high confidence optical diagnosis of polyps
timeFrame: 1 day
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine
Study officials:
References:
Clinical trial NCT04947592: SD-OCT Guided Treatment of Fungal Chorioretinitis
Official title: Outcome of SD-OCT Guided Oral Anti-fungal Treatment of Fungal Chorioretinitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fungal Retinitis
Keywords: fungal
chorioretinitis
OCT
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: at least 18 years old patient with fungal chorioretinitis

Brief summary: Fungal Chorioretinitis is a vision threatening condition.The investigators evaluate the efficacy of SD-OCT role in the treatment

Detailed description: Baseline ,and postoperative 1 ,6 and 12 months full ophthalmic examination and SD-OCT was done.Procedure included oral fluconazole treatment 1 tablet once for 14 days

Eligibility criteria: Inclusion Criteria:

- fungal chorioretinitis

Exclusion Criteria:

* vitritis
* other macular lesion
* macular scar

Primary outcomes:
measure: Best corrected visual acuity (BCVA)
timeFrame: 6 months
Secondary outcomes:
measure: optical coherence tomography (OCT) foveal thickness
timeFrame: 6 months
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: INMC
Study officials:
affiliation: Benha University
name: TAREK ELHAMAKY
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04593992: HTEMS Treatment of Diabetic Polyneuropathy
Official title: High-tone External Muscle Stimulation for Treatment of Diabetic Polyneuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Polyneuropathy
Keywords: diabetes
neuropathy
pain
HTEMS
Lead sponsor: West German Center of Diabetes and Health
Sponsor class: OTHER
Collaborators: name: gbo Medizintechnik AG
First posted: 2020-10-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: So far, there are no sufficient pharmacologic therapies for the treatment of diabetic neuropathy. Therefore, we evaluated application of high-tone external muscle stimulation (HTEMS) compared to placebo treatment in patients with diabetic neuropathy.

Detailed description: Patients (n=80) with symptomatic diabetic neuropathy will be included into this randomized controlled trial. Each intervention will be administered for a period of at least 30 min on at leat 5 days in a week. Health impairments will be assessed using the neuropathy symptom score (NSS) before, during and after intervention.

Eligibility criteria: Inclusion Criteria:

* symptomatic diabetic neuropathy
* stable oral analgesic regimen

Exclusion Criteria:

* history of drug or alcohol abuse
* cardiac pacemaker or defibrillator
* pregnancy

Primary outcomes:
measure: Neuropathy symptom score
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: West-German Centre of Diabetes and Health, Düsseldorf Catholic Hospital Group
Study officials:
References:
Clinical trial NCT01949792: A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors
Official title: An Open-label Single- and Multiple-dose Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa Following i.v. Administration of One Dose of 270 Microg/kg and Three Doses of 90 Microg/kg in Patients With Haemophilia A or B With or Without Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Congenital Bleeding Disorder
Haemophilia A
Haemophilia A With Inhibitors
Haemophilia B
Haemophilia B With Inhibitors
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-09-25
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of rFVIIa (activated coagulation factor VII) following one single injection of 270 microg/kg compared to three injections of 90 microg/kg rFVIIa in patients with haemophilia.


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Male patients with confirmed diagnosis of severe congenital haemophilia A or B (higher than 1% FVIII or FIX) with or without inhibitors to coagulation factors VIII or IX, based on medical records

Exclusion Criteria:

* Congenital or acquired coagulation disorder other than congenital haemophilia A or B
* Any clinical signs or known history of arterial thrombotic events or previous deep vein thrombosis or pulmonary embolism (as defined by available medical records)
* Use of any anticoagulant (e.g. un-fractionated or low molecular weight heparin, vitamin-K antagonists, direct thrombin inhibitors or factor Xa inhibitors)
* Bleeding prophylactic treatment or FVIII or FIX immune tolerance induction (ITI) treatment during the trial period

Primary outcomes:
measure: Thromboelastography (TEG) parameter Maximum Thrombosis Generation (MTG;'maximum velocity')
timeFrame: 10 minutes post-dose for 270 microg/kg and 10 minutes after the first injection of 90 microg/kg
Secondary outcomes:
measure: TEG parameters r-time, MTG, alpha angle, and maximum amplitude (MA)
timeFrame: Prior to and 24 hours following the administrtion of 270 microg/kg and each of the 3 administrations of 90 microg/kg
Other outcomes:
Locations:
city: Madrid
country: Spain
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00730392: Etanercept in New Onset Type 1 Diabetes
Official title: "ENBREL® (Etanercept) Administration to Patients Newly Diagnosed With Type 1 Diabetes Mellitus: Feasibility-Safety Study" ("Study")
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes, Etanercept, honeymoon period
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2008-08-08
Enrollment: 18
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesized that the administration of Etanercept to children newly diagnosed with T1DM may be able to interdict the progression of T1DM. The aim of this study is to evaluate the feasibility and safety of Etanercept administration to pediatric patients recently diagnosed with type 1 DM.

Detailed description: This is a double-blind randomized 24-week placebo-controlled feasibility and safety study. Subjects received study drug for a 24- week period, followed by 4 and 12-week wash out periods.

Eligibility criteria: Inclusion Criteria:

* Males and females subjects with T1DM aged 3-18 years
* Positive GAD 65 and/or islet cell antibody
* HbA1c at diagnosis above 6%
* Insulin regimen with 3 injection of insulin daily (as described below)
* White blood count between 3,000-10,000 and platelets \> 100,000
* Normal ALT and AST, creatinine \< 1.8 mg/dl
* T1DM duration equal or less than 4 weeks

Exclusion Criteria:

* Infection requiring IV antibiotics at diagnosis or within past 14 days from study entry
* BMI over 85th percentile for age and gender
* Unstable household
* Unable to provide compliance with study drug, insulin and study visits,
* Evidence of psychiatric disease in the potential study subject and/or primary care taker
* And chronic diseases, including additional autoimmune disorders with the exception of euthyroid autoimmune thyroiditis

Primary outcomes:
measure: The primary end points of this study are percent change from baseline for HbA1c and C-peptide area under the curve (AUC).
timeFrame: At baseline and at the end of the 24-week blind treatment
Secondary outcomes:
measure: Secondary end points are insulin dose and number of insulin injection discontinued, if any
timeFrame: At baseline and at end of the 24-week treatment period
Other outcomes:
Locations:
Study officials:
affiliation: School of Medicine and Biochemical Sciences-SUNYAB
name: Teresa Quattrin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mastrandrea L, Yu J, Behrens T, Buchlis J, Albini C, Fourtner S, Quattrin T. Etanercept treatment in children with new-onset type 1 diabetes: pilot randomized, placebo-controlled, double-blind study. Diabetes Care. 2009 Jul;32(7):1244-9. doi: 10.2337/dc09-0054. Epub 2009 Apr 14.
Clinical trial NCT05418192: Effects of Dosing and Environment on Gross Motor and Spasticity in Spastic Quadriplegic
Official title: Effects of Therapeutic Dosing Through Enriched Environment on Gross Motor Function and Spasticity in Spastic Quadriplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spastic Cerebral Palsy
Keywords: Therapeutic Dosing
Enriched Environment
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 82
Sex: ALL
Minimum age (years): 7
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study focuses on how enriched environment along with the traditional physical therapy improves the gross motor function in spastic quadriplegic cerebral palsy children. And how much dosing is required to gain that clinically significant improvement.

Detailed description: There is still a blurred area regarding dosage parameter in cerebral palsy rehabilitation. This study is focused primarily on the fact that level appropriate selection of time, type, frequency, and intensity of intervention (sensory and motor) plays a very vital role in developing gross motor functions. Secondly it is very important to establish the impact of enriched environmental inputs and foster parent capacity as an early intervention taking into account cerebral palsy (CP) specific positioning and handling along with level appropriate sensory inputs.

Eligibility criteria: Inclusion Criteria:

Age Group between 7 months to 5 years.

* Spastic Quadriplegia
* Gross Motor Function Classification System (GMFCS) level IV and V
* Modified Ashworth Scale (MAS): level 2
* Both Gender

Exclusion Criteria:

* History of fits

  * Medications
  * Dislocation and fracture
  * Visual/Auditory Impairment
  * Patients taking therapy from multiple places

Primary outcomes:
measure: Gross Motor Function
timeFrame: 5 months
Secondary outcomes:
measure: Spasticity
timeFrame: 5 months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: The University of Lahore Teaching Hospital
state: Punjab
Study officials:
affiliation: University of Lahore
name: Safa Saleem, DPT
role: PRINCIPAL_INVESTIGATOR
References: