louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04436536: Gait Speeds and Demands in Chronic Stroke Patients: A Multi-dimensional Investigation
Official title: Gait Speeds and Demands in Chronic Stroke Patients: A Multi-dimensional Investigation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Stroke
Keywords: stroke
gait
dual tasks
motor learning
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
Collaborators: name: Tainan Hospital, Ministry of Health and Welfare
First posted: 2020-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigated the effect of treadmill walking training with and without random speed changes in persons in the chronic stage of stroke. It was hypothesized that random speed change group will show less attention and balance demands for speed change in level walking.

Detailed description: This study includes chronic stroke patients who will be randomly assigned to blocked or random walking speed change group to receive 30 min per session, 3 sessions per week for 2 weeks' walking training on a treadmill. The outcome measures include gait characteristics under 3 tasks x 3 speed conditions x 2 attention conditions on an obstacle-free walk way. The three tasks are normal walking, narrow based walking and obstacle crossing. The three speed conditions are constant (preferred) speed, speeding up (preferred to maximum speed), and slowing down (maximum to preferred speed). The two attention conditions are none and serial subtraction of 3 during walking. Clinical sensorimotor function assessment, including hand grip strength, plantar sensitivity, stroke rehabilitation assessment of movement and Fugl-Meyer lower extremity motor scale will be conducted for subject characterization.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with first stroke for at least 6 months
* Able to walk for at least 20 minutes independently without exhaustion
* Residual gait deficits
* Resting blood pressure is lower than 150/90 mmHg

Exclusion Criteria:

* Unable to follow experimental instructions during the process
* Any pain, inflammation, or other neuromuscular or musculoskeletal conditions in the lower limbs that affect walking ability
* Unstable health problems

Primary outcomes:
measure: stride characteristics
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
affiliation: National Cheng Kung University
name: Lin Sang-I, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00844636: A Trial of Blunt Needles for the Reduction of Needlestick Injuries During Cesarean Section
Official title: A Randomized Trial of Blunt Needles for the Reduction of Needlestick Injuries During Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glove Perforations
Needlestick Injuries
Keywords: Needlestick injuries
Glove perforations
Blunt Needles
Glove perforations of surgeons, assistants
Needlestick injuries of same
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2009-02-16
Enrollment: 194
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study was to determine if blunt needle use during cesarean section closure protects against glove perforation and percutaneous injury to the surgeon and surgical assistant. A secondary objective was to determine physician satisfaction with blunt needles during the surgery.


Eligibility criteria: Inclusion Criteria:

* Female
* Pregnant
* Undergoing a cesarean section

Exclusion Criteria:

* Under age 18
* Non-English speaking

Primary outcomes:
measure: Number of observed glove perforations
timeFrame: 1 day
Secondary outcomes:
measure: Physician satisfaction with the needle assignment
timeFrame: 1 day
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Scott A Sullivan, MD
role: STUDY_DIRECTOR
References:
citation: Sullivan S, Williamson B, Wilson LK, Korte JE, Soper D. Blunt needles for the reduction of needlestick injuries during cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2009 Aug;114(2 Pt 1):211-216. doi: 10.1097/AOG.0b013e3181ae9b4a.
Clinical trial NCT04106336: Cortical Excitability and Role of rTMS in Cannabis Use Disorder
Official title: Cortical Excitability and Role of rTMS in Cannabis Use Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Cannabis Use Disorder, Moderate
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Repetitive transcranial magnetic stimulation (rTMS) and cortical excitability have a role in cannabis use disorder


Eligibility criteria: Inclusion Criteria:

* 18to 50 years of age
* cannabis use disorder according to DSM 5 definition
* clear consent to participate in study

Exclusion Criteria:

* cardiac peacemaker
* metal implant in the head as participate will be applied to magnetic field of TMS
* current intake of any medication affect cognition (as anti psychotic and anti epileptic)
* current history of neurological , psychiatric or general medical disease .current or previous drug (other than cannabis )or alcohol abuse or participation in another trial during the past 8 weeks .
* age younger than 18 and older than 50 years

Primary outcomes:
measure: Determination of role of rTMS for reducing cannabis craving
timeFrame: 1 year
Secondary outcomes:
measure: Estimation of cortical excitability in cannabis addict
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04441736: Post -Extubation Respiratory Failure
Official title: Different Oxygenation Modalities for Early Post Extubation Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Insufficiency
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: comparing high flow nasal cannula , conventional oxygen tharapy and non invasive ventilation post-extubation period for patients mechanically ventilated due to respiratory failure regarding re-intubation rate, ICU outcome \& 28 days mortality

Detailed description: patients with respiratory failure either type I or type II planned for extubation will be divided into 3 groups post extubation :

Group I: will receive high flow nasal cannula giving oxygen 60 litres / minute flow group II: will receive nasal cannula up to 10 litres / minute group III: will receive non invasive ventilation

Data of the patients will be collected for 28 days post-extubation and analysed

Eligibility criteria: Inclusion Criteria:

* respiratory failure type I and Type II

Exclusion Criteria:

* Mechanical ventilation due to other cause such as disturbed conscious level or respiratory muscle weakness

Primary outcomes:
measure: Number of participants with post extubation respiratory failure
timeFrame: 7 days
Secondary outcomes:
measure: Rate of ICU stay and mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Cairo University
name: Yasser Nassar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04224649: To Evaluate the Efficacy and Safety of Injection With HARA as Compared to Restylane® Lidocaine in Temporary Correction of Nasolabial Folds
Official title: A Single Center, Randomized, Subject & Evaluator-blind, Matched Pairs, Active-controlled Design Pivotal Study to Evaluate the Efficacy and Safety of Injection With HARA as Compared to Restylane® Lidocaine in Temporary Correction of Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nasolabial FOLD
Lead sponsor: Huons Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Humedix Co., Ltd.
First posted: 2020-01-13
Enrollment: 67
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * Investigational Device : HARA (Hyaluronic Acid Filler)
* Title : A Single center, Randomized, Subject \& Evaluator-blind, Matched pairs, Active-controlled design Pivotal study to Evaluate the Efficacy and Safety of Injection with HARA as Compared to Restylane® Lidocaine in temporary Correction of Nasolabial folds
* Sites and investigators : Chung-ang University Hospital(Seoul), Beom-Joon Kim, M.D, Ph.D
* Objective : To compare the non-inferiority of HARA with Restylane® Lidocaine for evaluation of the efficacy and safety on Nasolabial Folds


Eligibility criteria: Inclusion Criteria:

1. Those who agreed to this treatment and signed the Informed Consent Form
2. Those who are 19 years old or more and desire to take correction of nasolabial folds
3. Those who have an intention of refraining from other cosmetic treatment(other filler injection, laser or chemical peeling, Botox injection or wrinkle reduction) during the clinical study period
4. Those whose Wrinkle Severity Rating Scale (WSRS) is more than 2 points at least

Exclusion Criteria:

1. Those who are sensitive to lidocaine or other amide anesthesia
2. Those who are sensitive to control device
3. Those who are pregnant or lactating, or expect pregnancy
4. Those who are judged by the subinvestigator to be improper for this study

Primary outcomes:
measure: Assessment By independent evaluator
timeFrame: Week 24 From baseline Visit(=Investigational Device Injection)
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Huons
Study officials:
References:
Clinical trial NCT03808649: Individualized Volume of Oral Contrast Agent in CT Enterography
Official title: Individualized Volume of Oral Contrast Agent Based on the Clinical Risk Factor in CT Enterography: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CTE
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2019-01-17
Enrollment: 180
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: OTHER

Brief summary: Small bowel distension is mandatory for the assessment of the bowel wall in CT enterography, but some patients were sufferring inadequate small bowel distension. So, it is important to prescribe personalized regimen according to patient's personal characteristics.

Detailed description: CT enterography has become an important tool in the evaluation of small bowel diseases, especially in patients with inflammatory bowel diseases. Small bowel distension is mandatory for the assessment of the bowel wall. So, it is important to find clinical risk factors for inadequate small bowel distension and prescribe personalized regimen according to patient's personal characteristics to reduce patient acceptance.

Eligibility criteria: Inclusion Criteria:

* patients undergoing CT enterography

Exclusion Criteria:

* patients with a history of GI surgery
* patients with known or suspected bowel obstruction or perforation
* patients with severe chronic renal failure (creatinine clearance\<30 ml/min)
* patients with uncontrolled hypertension (systolic blood pressure\>170 mm Hg, diastolic blood pressure\>100 mm Hg)
* patients with acute upper GI bleeding
* patients with severe inflammatory bowel disease or megacolon
* patients with documented allergy to intravascular contrast agent
* patients with pregnancy or lactation
* patients hemodynamically unstable
* patients unable to give informed consent.

Primary outcomes:
measure: Clinical risk factors for inadequate small bowel distention
timeFrame: 2 month
measure: Adequate small bowel distention
timeFrame: 4 month
Secondary outcomes:
measure: Side effects
timeFrame: 4 month
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Yanqing Li, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00907049: Association Between Neck Pain and Quality of Sleep
Official title: Study of the Association Between Neck Pain and the Quality of Sleep
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Neck Pain
Disability
Keywords: quality of sleep
neck pain
disability
catastrophizing
depression
Lead sponsor: Kovacs Foundation
Sponsor class: OTHER
First posted: 2009-05-22
Enrollment: 424
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen for neck pain in the primary care centers participating in the study.

Brief summary: A prospective study to assess the association between the change in quality of sleep and the change in intensity of pain in Spanish patients seen for subacute or chronic neck pain. The objective is to determine the prevalence of sleep alterations, the association between quality of sleep and intensity of pain, degree of disability, intensity of catastrophizing and depression.


Eligibility criteria: Inclusion Criteria:

* patients with nonspecific neck pain of more than 14 days duration
* seen in health centers participating in the study
* patients who accept to participate and sign the consent form
* without age limits and regardless of gender

Exclusion Criteria:

* inability to complete the questionnaires (illiteracy, dementia)
* inflammatory rheumatologic disease, fibromyalgia, cancer in last 5 years

Primary outcomes:
measure: Assessment of the association between neck pain and quality of sleep in patients with subacute or chronic nonspecific neck pain.
timeFrame: 3 months
Secondary outcomes:
measure: Assessment of the association between quality of sleep and disability, catastrophizing and depression in patients with subacute or chronic nonspecific neck pain.
timeFrame: 3 months
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Kovacs Foundation
state: Balearic Islands
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
Study officials:
affiliation: Kovacs Foundation, Palma de Mallorca, 07012, Spain
name: Francisco M Kovacs, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Ramón y Cajal, Unidad de Bioestadística Clínica, Madrid, Spain
name: Víctor Abraira, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fejer R, Kyvik KO, Hartvigsen J. The prevalence of neck pain in the world population: a systematic critical review of the literature. Eur Spine J. 2006 Jun;15(6):834-48. doi: 10.1007/s00586-004-0864-4. Epub 2005 Jul 6.
citation: Moldofsky H. Sleep and pain. Sleep Med Rev. 2001 Oct;5(5):385-396. doi: 10.1053/smrv.2001.0179.
citation: McCracken LM, Iverson GL. Disrupted sleep patterns and daily functioning in patients with chronic pain. Pain Res Manag. 2002 Summer;7(2):75-9. doi: 10.1155/2002/579425.
Clinical trial NCT01971749: Register of Treatment of Unprotected Left Main Coronary Artery Stenosis in Andalucía
Official title: Multicenter, Prospective, Observational Study of of Treatment of Unprotected Left Main Coronary Artery Stenosis in Andalucía
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Unprotected Left Main Coronary Artery Stenosis
Keywords: Coronary stent procedure (CSP
Coronary-artery bypass grafting (CABG)
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
First posted: 2013-10-29
Enrollment: 315
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with unprotected left main coronary artery stenosis in Andalucia who can follow a year monitoring in participating centers

Brief summary: Register of treatment of unprotected left main coronary artery stenosis in Andalucia (RETRATO).


Eligibility criteria: Inclusion Criteria:

* New diagnosed of unprotected left main coronary artery stenosis (lesion ≥50%)
* Have signed informed consent

Exclusion Criteria:

* Participating in other research protocol
* Inability to follow a monitoring

Primary outcomes:
measure: Measure the MACE survival in the coronary-artery bypass grafting (CABG) group and in the coronary stent procedure (CSP) group, to identify the differences between both groups in the short and medium-term follow up
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Hospital Torrecárdenas
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez
city: Málaga
country: Spain
facility: Hospital Carlos Haya
city: Málaga
country: Spain
facility: Hospital Clínico Universitario Virgen de la Victoria
Study officials:
affiliation: Hospital Carlos Haya
name: Carlos Sánchez González
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04738149: Effect of Microneedling, Bimatoprost and Excimer in Vitiligo Treatment
Official title: A Proof of Concept, Split Study Measuring the Effectiveness of Topical ProstaglandinF2alpha, Microneedling and Excimer Laser in the Treatment of Vitiligo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Vitiligo
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to treat vitiligo with a topical PGF2α, microneedling and excimer laser. The goal is to have greater repigmentation than the standard of care (excimer) after 12 weeks of treatment.

The study is a pilot, split study meaning the patient will receive one experimental and one standard of care treatment on symmetric lesions of similar location, geometrics and size.

Enrolled subjects will present biweekly to clinic on the same two days for twelve weeks. One lesion will be treated with microneedling, topical PGF2α and calibrated excimer laser, while the parallel lesion will be excimer laser alone. Physical exam, photographs, and a review of of the subjects medical records will occur in the study. Changes in size, appearance, and adverse events will be monitored throughout the study. The patient will also agree to close up photographs of their lesions throughout the study.

The possible benefit of joining this study is that the treatment received may be more effective than the other study treatment or then other available treatments for vitiligo, although this cannot be guaranteed.


Eligibility criteria: Inclusion Criteria:

* All patients 18 years and older with the diagnosis of Vitiligo.

Exclusion Criteria:

* Female patients currently pregnant or lactating
* Female patients with plans to come pregnant during the next 3 months
* Allergic reactions to topical or oral prostaglandins
* Uncontrolled skin disease
* History of glaucoma
* Concomitant disease or therapy that interferes with the diagnosis that might interfere with vitiligo diagnosis sand evaluation.
* Patients currently using other treatments for Vitiligo, such as topical steroids, calcineurin inhibitors, and Vitamin D analogs within 2 weeks of study initiation
* Inability or unwillingness of subject or legal guardian/representative to give

Primary outcomes:
measure: Percentage of skin repigmentation after 12 weeks
timeFrame: Post treatment (at week 12)
measure: Number of patients with perceived improvement after 12 weeks.
timeFrame: Week 12
Secondary outcomes:
measure: Change in quality of life
timeFrame: Baseline and post treatment approximately 12 weeks
measure: Change in quality of life
timeFrame: Baseline and post treatment approximately 12 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT02702349: The Frequency of Positive Challenge Test to Penicillin in Children Suspected to Have Allergy to Penicillin
Official title: The Frequency of Positive Challenge Test to Penicillin in Children Suspected to Have Allergy to Penicillin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Penicillin Allergy
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-03-08
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The incidence of reactions during penicillin challenge tests among children with suspected penicillin allergy

Detailed description: children who are suspected to have penicillin allergy due to a suspected allergic reaction during penicillin treatment are sent for allergy investigation to role out allergy. Patients go through penicillin test and if negative are challenged by oral administration under medical observation. The investigators would like to check the incidence among our pediatric pediatric patients.

Eligibility criteria: Inclusion Criteria:

* Children older then 6 month with suspected penicillin allergy

Exclusion Criteria:

* Children under 6 month old

Primary outcomes:
measure: The incidence of reactions during penicillin challenge tests among children with suspected penicillin allergy
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hillelyaffe medical center
name: vered schichter- konfino, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03332849: Multiple Ascending Dose Study of HM12470 in Type 1 and Type 2 Diabetes Mellitus
Official title: A Phase 1, Multiple Ascending Dose Glucose Clamp Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of HM12470 in Comparison to Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type1 Diabetes Mellitus
Type2 Diabetes Mellitus
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a phase 1 multiple ascending dose (MAD) study, conducted in subjects with Type 1 and Type 2 diabetes mellitus


Eligibility criteria: Inclusion Criteria:

* T1DM or T2DM
* Female subjects must be non-pregnant and non-lactating

Exclusion Criteria:

* Pregnant or lactating women
* Participation in an investigational study within 30 days prior to dosing

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 1 month
Secondary outcomes:
measure: Cmax of HM12470
timeFrame: 1 month
measure: AUC of HM12470
timeFrame: 1 month
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Hanmi Investigative Site
state: California
Study officials:
References: