louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01336517: Evaluation of the Effect of an Ankle Foot Orthoses for Ambulatory Function
Official title: Comprehensive Evaluations of the Effect of an Ankle Foot Orthoses for Ambulatory Function in Adults With Hemiplegia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemiplegia, Spastic
Keywords: Stroke
Hemiplegia
AFO
Gait
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2011-04-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a history of hemiplegia secondary to stroke, between the ages of 18 and 75, who are greater than 6 months post and have been prescribed a custom molded AFO for assistance with gait deviations

Brief summary: The main purpose of this investigation is to evaluate the effect of a lower leg brace on walking efficiency and community walking in people who have weakness in one side of the body caused after a stroke. The evaluation will consist of several tests that will evaluate movement, tightness, balance and sensation in affected leg.

Detailed description: To comprehensively evaluate the effect of an AFO on ambulatory function and loading in hemiplegic gait. This study is addressing important questions regarding the effect of an AFO on gait and introduces technology for quantifiable objective assessment of AFO effectiveness. It will attempt to identify if AFO wear compliance increases community ambulation and walking efficiency bilaterally. Research is needed to fully understand how compliance affects mobility outcomes.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and 75
* Have sustained a stroke at least 6 months prior to study enrollment
* Use a prescribed custom brace while walking
* Have no history of injury, orthopedic or other medical problem in the normal leg
* Be able to walk independently or with close supervision for 25 feet without a brace or cane
* Wear shoes sizes 5 1/2 - 11 US womens or size 6-13 US mens

Exclusion Criteria:

* Orthopedic problems or history that will interfere with walking or limit the range of motion of legs
* Neurological illness, history, or conditions that my interfere with walking except for stroke
* Psychiatric conditions or history that would interfere with the ability to walk or follow directions
* Serious lung or heart condition that could severely limit the ability to walk

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation Research Center
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Karen Nolan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00593541: Development of New Software Capabilities for Use With Cardiovascular Magnetic Resonance Imaging
Official title: Development of New Software Capabilities for Use With Cardiovascular Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Abnormalities, Cardiovascular
Keywords: MRI
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2008-01-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Noraml volunteers and patients with known or suspected cardiovascular disease

Brief summary: This Protocol is intended to facilitate development and testing of new cardiovascular MRI software capabilities by UC Davis Research Faculty, as well as to facilitate the evaluation of new software capabilities provided by GE and Siemens.

Detailed description: This protocol will permit normal subjects, as well as patients with suspected or proven medical conditions, to undergo MRI studies using the new software capabilities. This Protocol is not restricted to imaging of a particular organ system or disease. The Protocol does not involve injection of any contrast agent, or other minimally-invasive or invasive procedure. It is intended only for those cases for which the only requirement of the subject is to relax and lie still while imaging is being performed.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Ability to give informed, written consent
* Not Pregnant or breastfeeding

Exclusion Criteria:

* Electrically, magnetically, or mechanically activated implants (for example, cardiac-pacemakers)
* Ferromagnetic implant, such as an aneurysm clip, surgical clip, or prosthesis
* History of uncontrolled claustrophobia

Primary outcomes:
measure: Extend or generalize certain capabilities, such as new data acquisition pulse sequences, new image processing and analysis software for structural and functional analysis of the MR images
timeFrame: Post-scanning
Secondary outcomes:
measure: Improve image quality by various techniques (e.g. reducing the effects of motion)
timeFrame: Post-scanning
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Davis
name: Michael H Buonocore, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02717741: A Study of Tafetinib in Chinese Patients With Advanced Solid Tumor
Official title: A Phase I Study to Determine the Safety and Pharmacokinetic Study of Tafetinib in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Nanjing Yoko Biomedical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-03-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Tafetinib is an oral multitargeted tyrosine kinase inhibitor that inhibits Vascular Endothelial Growth Factor Receptor (VEGFR).

This phase I trial was conducted to evaluate the pharmacokinetics (PK), safety, and preliminary efficacy of tafetinib in Chinese patients with advance solid tumor. The study are conducting in Cancer Hospital Chinese Academy of Medical Sciences.


Eligibility criteria: Inclusion Criteria:

* Adult patients with histologically confirmed advanced solid malignancies.
* ECOG score 0-1.
* 18-65 years old.
* Withdrawal other chemotherapy drugs more than 30 days. No nitrosoureas or mitomycin C within the previous 6 weeks.
* Function of organs must meet the following requirements:
* Neutrophil count ≥1500/ul;
* AST and ALT≤1.5 times the upper limit of normal (ULN);
* Total serum bilirubin≤1.5 times ULN;
* Hemoglobin≥90g/L;
* Platelet≥100000/ul;
* The creatinine in the normal range or creatinine clearance rate ≥60ml/min;
* Left ventricular ejection fraction (LVEF) ≥50%;
* Females of childbearing age are required to be practicing effective contraceptive measures and to have a negative serum or urine pregnancy test before study.
* Written informed consent is obtained.

Exclusion Criteria:

* included a history of or current brain metastases, clinically significant cardiovascular disease or uncontrolled hypertension.

Primary outcomes:
measure: Dose-limiting toxicity
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01199341: A Drug-Drug Interaction Study to Study the Effect of AZD1981 on Warfarin
Official title: A Phase I, Open Label, Randomised, Parallel Group Study of Repeated Oral Doses of AZD1981 (100 mg Twice Daily and 400 mg Twice Daily) for Two Weeks and Single Doses of Warfarin (25 mg) to Evaluate the Pharmacokinetic Interaction of AZD1981 and Warfarin and the Effect of AZD1981 on Warfarin Pharmacodynamics in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmakokinetic
Keywords: Phase 1
Drug-Drug interaction
warfarin
AZD1981
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-09-10
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of this study is to determine whether the treatment with AZD1981 affect the exposure of Warfarin.


Eligibility criteria: Inclusion Criteria:

* Have a body mass index between 19 and 30 kg/m2 and weight at least 65 kg and no more than 100 kg
* Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to screening
* Volunteers must be willing to use barrier methods of contraception during study and 3 months after the end of their participation in the study

Exclusion Criteria:

* Volunteer that is inferred to have an increased sensitivity to warfarin based on genotype of CYP2C9 and VKORC1.
* Any clinically significant disease or disorder
* Any clinically relevant abnormal findings in physical examination

Primary outcomes:
measure: Pharmacokinetics for (R)- and (S)-Warfarin, respectively measured by Cmax and Area Under the Curve (AUC)
timeFrame: PK sampling will be performed regularly from Day 1 to Day 22
Secondary outcomes:
measure: Explore possible changes in the anticoagulative activity of Warfarin measured by INR .
timeFrame: Will be performed at screening and at all visits during the study period.
measure: Pharmacokinetics for AZD1981 measured by AUCτ, Css,max, tmax,ss and CLss/F
timeFrame: PK sampling will be performed regularly from Day 15 to Day 22.
measure: Safety and tolerability of AZD1981
timeFrame: Safety will be monitored continuously and safety assessments will be made on several occasions throughout the whole study.
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Christer Hultqvist, MD
role: STUDY_DIRECTOR
affiliation: Quintiles AB
name: Aslak Rautio
role: PRINCIPAL_INVESTIGATOR
affiliation: Quintiles AB
name: Wofgang Kühn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00522041: A Study to Determine the Effect of Nitroglycerin Ointment 0.4% (Cellegesic) on the Pain Associated With Chronic Anal Fissures
Official title: A Randomized. Double-blind, Placebo-controlled, Multi-national Study to Determine the Effect of Cellegesic Nitroglycerin Ointment 0.4% (Cellegesic) on the Pain Associated With a Chronic Anal Fissure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fissure in Ano
Pain
Keywords: Pain associated with chronic anal fissure
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2007-08-29
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anal fissure is a solitary ulcer in the squamous epithelium of the anus causing intense anal pain especially during defecation and for 1 or 2 hours afterwards. There are no approved drugs in the United States (US) for this condition and surgery is often the treatment choice. Strakan is conducting this confirmatory study so the product can be submitted for regulatory approval in the US. Strakan currently markets this product throughout Europe.

The objective of this study is to determine the effect of nitroglycerin ointment 0.4% (Cellegesic) versus placebo on average pain intensity over every 24 hour period for up to 21 days of treatment in 250 patients.


Eligibility criteria: Inclusion Criteria:

* Consenting patients of either sex.
* Between 18 and 75 years of age.
* With a single, chronic, posterior midline anal fissure.
* Defined as having anal pain for the 6 weeks prior to Screening.

Exclusion Criteria:

* More than one anal fissure.
* A fistula-in-ano or anal abscess.
* Inflammatory bowel disease.
* Fibrotic anal stenosis.
* Anal fissure secondary to an underlying condition.
* Any anal surgery.
* Concomitant medication that may interfere with study evaluation.

Primary outcomes:
measure: Change From Baseline in Pain Intensity at Days 14-18
timeFrame: Baseline to Day 18
Secondary outcomes:
measure: Time to an Improvement in Pain Intensity
timeFrame: Baseline to Day 21
measure: Percentage of Responders
timeFrame: Baseline to Day 18
Other outcomes:
Locations:
Study officials:
affiliation: Strakan Pharmaceuticals, Inc.
name: Gemma Clark
role: STUDY_DIRECTOR
References:
citation: Berry SM, Barish CF, Bhandari R, Clark G, Collins GV, Howell J, Pappas JE, Riff DS, Safdi M, Yellowlees A. Nitroglycerin 0.4% ointment vs placebo in the treatment of pain resulting from chronic anal fissure: a randomized, double-blind, placebo-controlled study. BMC Gastroenterol. 2013 Jul 1;13:106. doi: 10.1186/1471-230X-13-106.
Clinical trial NCT03917641: Effectiveness of Khat on Eyelid Wound Healing After Oculoplastic Surgery - a Prospective Study.
Official title: Effectiveness of Khat on Eyelid Wound Healing After Oculoplastic Surgery - a Prospective Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hematoma
Surgical Wound
Surgery
Eye Bruise
Edema
Keywords: Oculoplastic Surgery
Khat leaves
Post operative care
Edema
Hematoma
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-04-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each participant is his own control
Primary purpose: TREATMENT

Brief summary: The post operative routine after Oculoplastic Surgery includes usage of cold compressions for symptomatic relief and decreasing of the edema and local hematomas in the first few days after the surgery. Khat (Catha edulis) is a plant that is used mainly for chewing and has a known stimulating effect, some patients report major improvement after including these leaves in the compressions they use after surgery. Khat contains the chemical ingredients Cathine and Cathinone, which are amphetamine-like alkaloids and probably the main contributors for its active effects. Our main goal is to use compressions that include the Khat leaves and check their effect on reducing the edema and hematomas after oculoplastic surgery.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent blepharoplasty and/or ptosis repair

Exclusion Criteria:

* Patients who were operated on one eye only
* Patients who underwent a different surgery in each eye

Primary outcomes:
measure: Edema
timeFrame: 7 days post op
measure: Hematoma
timeFrame: 7 days post op
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba_Medical_Center
Study officials:
References:
citation: Malhotra R, Ziahosseini K, Poitelea C, Litwin A, Sagili S. Effect of Manuka Honey on Eyelid Wound Healing: A Randomized Controlled Trial. Ophthalmic Plast Reconstr Surg. 2017 Jul/Aug;33(4):268-272. doi: 10.1097/IOP.0000000000000743.
Clinical trial NCT03163641: Safety and Effectiveness of OBG vs.a Bandage Contact Lens for Large Corneal Epithelial Defects in Patients Post-PRK.
Official title: A Randomized, Masked (Reading Center), Prospective Pilot Study of the Safety and Effectiveness of the EyeGate Ocular Bandage Gel, a 0.75% Crosslinked Hyaluronic Acid Applied Topically, Versus a Bandage Contact Lens for Acceleration of Re-epithelialization of Large Corneal Epithelial Defects in Patients Having Undergone Photorefractive Keratectomy (PRK).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Epithelial Wound
Keywords: Photorefractive Keratectomy, Corneal Defect
Lead sponsor: Eyegate Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-23
Enrollment: 45
Sex: ALL
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized (Reading Center), masked, controlled study in up to 45 subjects who have undergone bilateral PRK with epithelial removal using alcohol in a 9.0 mm well or trephine at the time of surgery to ensure consistency of the size of the ablation area.

Detailed description: This is a prospective, randomized (Reading Center), masked, controlled study in up to 45 subjects who have undergone bilateral PRK with epithelial removal using alcohol in a 9.0 mm well or trephine at the time of surgery to ensure consistency of the size of the ablation area. Subjects will be assigned to one of three treatment arms on Day 0.

Eligibility criteria: Inclusion Criteria:

* Able and willing to comply with the protocol

Exclusion Criteria:

-

Primary outcomes:
measure: Time to corneal re-epithelization post PRK
timeFrame: Day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston, Texas
state: Texas
Study officials:
affiliation: Eyegate Pharmaceuticals, Inc.
name: Barbara Wirostko, M.D.
role: STUDY_DIRECTOR
References:
citation: Durrie DS, Wolsey D, Thompson V, Assang C, Mann B, Wirostko B. Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy. J Cataract Refract Surg. 2018 Mar;44(3):369-375. doi: 10.1016/j.jcrs.2018.01.018.
Clinical trial NCT04965441: CAS Versus Traditional Freehand Technique for Mandibular Reconstruction With Free Vascularized Fibular Flap
Official title: Computer-assisted Versus Traditional Freehand Technique for Mandibular Reconstruction With Free Vascularized Fibular Flap: A Matched-pair Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Operation Time
Complication of Surgical Procedure
Keywords: Computer-Assisted Surgeries
Mandibular Reconstruction
Matched-Pair Analysis
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 153 patients who underwent mandibular reconstruction by VFF were included from Jan 1999 to Dec 2019.

Brief summary: A total of 153 patients who underwent mandibular reconstruction by VFF were included from Jan 1999 to Dec 2019. The mandibular resection and reconstruction were performed by four experienced oral and maxillofacial surgeons. Reasons for reconstruction were oncologic, osteoradionecrosis, trauma, and osteoporosis. All the patients were followed up postoperatively for at least one year. Eighteen pairs were formed with the matched cohort consisting of a total of 36 patients who underwent primary mandibular reconstruction without additional combined flaps. The surgery-related and patient-related continuous and categorical parameters were assessed in both groups.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of head and neck cancer
* Received mandibular reconstruction
* All patients were followed up postoperatively for at least one year

Exclusion Criteria:

* Patients received bone graft for jaw reconstruction before mandibular reconstruction

Primary outcomes:
measure: operation time
timeFrame: within the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
Clinical trial NCT02899741: Efficacy of Omega-3 as Adjunctive Therapy for Medically Intractable Epilepsy: A Prospective Open-label Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Epilepsy
Keywords: Medically intractable epilepsy, Omega-3
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether omega-3 is effective in the treatment of medically intractable epilepsy as adjunctive therapy.

Detailed description: This study will enroll total 30 patients with medically intractable epilepsy. The patients will be fully assessed on the enrollment, and then seizure frequency will be counted for three months without changing medication. After three months, Omega-3 will be administered for next three months. Seizure frequency, questionnaires evaluating mood and QOL, and adverse events are evaluated at each visit.

Eligibility criteria: Inclusion Criteria:

* Patients with medically intractable, focal or generalized, epilepsy: Patients with localization-related partial onset or generalized tonic/clonic seizure according to the International League Against Epilepsy (ILAE) can be included. Medically intractable epilepsy means that recurrent seizures occur even though two or more anti-epileptic drugs have been used appropriately for over one year.
* Seizure frequency criteria: three seizures per one month for recent 3 months before enrollment
* Seizure criteria: simple partial, complex partial, or tonic-clonic seizures
* Subjects with normal cognitive function: patients who can perform normal daily life. If not definite, enrollment will be done with K-MMSE score over 27.

Exclusion Criteria:

* Poor general medical condition: comorbid with heart, lung, liver diseases
* Patients who have history of pseudo-seizure
* Anti-epileptic drugs has been changed in recent one month.
* Chronic alcoholic
* Seizure count cannot be done since seizures occur successively.
* Allergy to fish
* High risk of bleeding such as trauma or operation
* Liver function abnormality
* Pregnant or lactating women, or women who plans to have children
* Patients who have participated in the other clinical trial in recent one month

Primary outcomes:
measure: Seizure frequency
timeFrame: three months
Secondary outcomes:
measure: Depressive mood
timeFrame: three months
measure: Anxiety
timeFrame: three months
measure: Quality of Life
timeFrame: three months
measure: Adverse events
timeFrame: three months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kon Chu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: