louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01976611: Safety and Efficacy of Botulinum Toxin Type A (BOTOX®) to Treat Chronic Migraine in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine Disorders
Headache
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-11-06
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with botulinum toxin Type A for chronic migraine in clinical practice.

Brief summary: This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of botulinum toxin Type A to treat Chronic Migraine in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Patients treated with botulinum toxin Type A for chronic migraine in clinical practice.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Number of Participants with Adverse Events and Adverse Drug Reactions
timeFrame: 4 Years
measure: Headache Impact Test-6 (HIT-6) Score Using a 5-Point Scale
timeFrame: 4 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02613611: HPV Screening (Human Papilloma Virus)
Official title: Screening for Human Papilloma Virus in Urine and Pap Smear.A Comparative Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HPV Testing
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2015-11-24
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 500 females attending colposcopy kasrelaini unit aging 18_45 years

Brief summary: Examination of cervical \&urine samples for HPV

Detailed description: 500 females attending colposcopy kasrelaini unit are included. History including age and parity is taken.urine samples are taken. Colposcopy will be done. Pap smear will be taken and sent for pathology.

Eligibility criteria: Inclusion Criteria:

* all females attending colposcopy kasrelaini unit aging 18_45 years

Exclusion Criteria:

* females with known cervical cancer
* females less than 18 or more than 45

Primary outcomes:
measure: Number of patients with positive urine test for HPV Number of patients with positive pap smear.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01834911: Effect of Tetrabenazine on Stroop Interference in HD
Official title: Effect of Tetrabenazine on Stroop Interference in Huntington Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Huntington Disease
Keywords: Huntington disease
HD
tetrabenazine
Stroop
Lead sponsor: New York Medical College
Sponsor class: OTHER
First posted: 2013-04-18
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Tetrabenazine has been shown to improve gating of abnormal visual stimuli and improve postural stability in Huntington disease (HD) patients as measured by computerized dynamic posturography testing. This study aims to elucidate whether partial dopaminergic depletion via low dose tetrabenazine has a similar effect on masking out of abnormal visual stimuli on the Stroop interference test.


Eligibility criteria: Inclusion Criteria:

* Established diagnosis of Huntington disease by movement disorders expert
* Patients currently taking tetrabenazine.
* Patients should not have taken dopamine receptor blocking medication for at least three days

Exclusion Criteria:

-

Primary outcomes:
measure: Change in Stroop Interference Score
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Terence Cardinal Cooke Health Care Center
state: New York
Study officials:
References:
citation: Fekete R, Davidson A, Ondo WG, Cohen HS. Effect of tetrabenazine on computerized dynamic posturography in Huntington disease patients. Parkinsonism Relat Disord. 2012 Aug;18(7):896-8. doi: 10.1016/j.parkreldis.2012.04.029. Epub 2012 May 22.
Clinical trial NCT01255111: Adaptation to Nocturnal Noninvasive Ventilation in Patients With Chronic Respiratory Failure (ROOMILA)
Official title: Adaptation to Nocturnal Noninvasive Ventilation in Patients With Chronic Respiratory Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Respiratory Failure
Keywords: Chronic respiratory failure
Noninvasive ventilation
Patient-ventilator interactions
Sleep
Sleep fragmentation
Lead sponsor: Groupe de Recherche sur le Handicap Respiratoire
Sponsor class: OTHER
First posted: 2010-12-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic respiratory failure at stable state who are indicated to domiciliary noninvasive ventilation

Brief summary: BACKGROUND: Adaptation to noninvasive ventilation (NIV) is a critical step for acceptability and efficacy of this treatment during sleep in patients with chronic respiratory failure.

AIM: To study the variability of patient-ventilator interactions during the first nights after initiation to NIV. Recorded data will be analyzed in part by dedicated tools from the non-linear dynamics theory.

PATIENTS AND METHODS: Patients with chronic respiratory failure at stable state and indicated to home NIV will be included. All patients will perform three polysomnographies (under spontaneous breathing at D1 and under NIV at D2 and D15 after NIV initiation). All ventilatory physiological data (pressure, flow, patient-ventilator interactions, oxygen saturation, non intentional leaks) will be recorded during sleep under NIV in the Sleep Laboratory of the Department and secondarily related to sleep architecture and quality of sleep.

EXPECTED RESULTS: This study will identify objective parameters that are associated to a satisfactory adaptation to nocturnal NIV.


Eligibility criteria: Inclusion Criteria:

* Chronic respiratory failure with indication to domiciliary NIV according to the international guidelines.

Exclusion Criteria:

* Decompensated respiratory failure attested by a pH \<7.35,
* Modification of respiratory symptoms during the four previous weeks, including signs of broncho-pulmonary infection,
* Respiratory frequency \>30/min.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Pulmonary & Respiratory Intensive Care Department - Rouen University Hospital
Study officials:
affiliation: Groupe de Recherche sur le Handicap Ventilatoire
name: Pr. Antoine CUVELIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01954511: Manual Therapy and Exercises Applied to Cervical Spine in Patients With Temporomandibular Disorders
Official title: Effects of Manual Therapy and Exercises Applied to Cervical Spine in Patients With Temporomandibular Disorders: Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Temporomandibular Joint Dysfunction Syndrome
Keywords: Stomatognathic diseases;
Temporomandibular Joint Dysfunction Syndrome
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
First posted: 2013-10-01
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study was to investigate the effect of a manual therapy and exercise program, focused on the rehabilitation of cervical function, on clinical signs and mandibular function in subjects with TMD.

Detailed description: Temporomandibular disorder (TMD) is a general term that refers to disorders associated with the temporomandibular joint (TMJ) and the masticatory muscles. Among the main symptoms are pre-auricular pain (in the region of the TMJ) and/or pain in the masticatory muscles.

It's usual to observe that subjects with TMD also present cervical alteration. Beside this, cervical postural alterations produced by muscle tension can influence mandibular position.

The intervention protocol was based on manual therapy, stabilization exercises and stretching.

The technique are:.

1. Upper cervical flexion mobilization;
2. C5 central posterior-anterior mobilization;
3. Stabilization exercise: Cranio-cervical flexor stabilization exercise
4. Stretching of muscles: upper trapezius, scalenes, semispinalis capitis; splenius capitis, sternocleidomastoid

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with myogenic or mixed temporomandibular disorders

Exclusion Criteria:

* Patients diagnosed with arthrogenic or discogenic temporomandibular disorders

Primary outcomes:
measure: Changing in maximum mouth opening pain free
timeFrame: Before and 5 days follow-up intervetion
Secondary outcomes:
measure: Changing of Pain
timeFrame: Before and 5 days follow-up intervetion
Other outcomes:
measure: Changing in Mandibular Function Impairment Questionnaire -MFIQ
timeFrame: Before and 5 days follow-up intervetion
Locations:
Study officials:
affiliation: Clinical professor - UFSCar
name: Ana Beatriz Oliveira, Phd
role: STUDY_DIRECTOR
affiliation: UFSCar
name: Letícia Bojikian Calixtre, Pt
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Salamanca
name: Francisco Alburquerque Sendín, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: UFSCar
name: Melina Nevoeiro Haik, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06521411: Pilot Subsidized and Culturally-adapted Community Supported Agriculture (CSA) Program
Official title: A Pilot Study of a Subsidized and Culturally-adapted Community Supported Agriculture (CSA) Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Habit
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study aims to apply community-engaged methods to refine and implement a culturally adapted systems-level program for improving diet in low income, Chinese American immigrants. Guided by the regular partner engagement, The researchers have organically developed a systems-level program to bring a subsidized community-supported agriculture (CSA) model to the community in a way that is aligned with cultural values, and that includes culturally appropriate produce and nutrition education.

This is a single-site proof of concept pilot program that will be evaluated using a pre-post-design.


Eligibility criteria: Inclusion Criteria:

* Adult age 18 years and over
* Currently living in Brooklyn
* Willing and able to provide consent

Exclusion Criteria:

• Unable to complete the baseline survey in English, Mandarin, or Cantonese

Primary outcomes:
measure: Change in Number of Different Vegetables Consumed
timeFrame: Baseline, Week 20
measure: Change in Diet Quality - Frequency
timeFrame: Baseline, Week 20
measure: Change in Diet Quality - Quantity of Serving
timeFrame: Baseline, Week 20
Secondary outcomes:
measure: Change in Food Insecurity Score
timeFrame: Baseline, Week 20
measure: Change in Social Cohesion Score
timeFrame: Baseline, Week 20
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Stella Yi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03579511: Learning Curve of External Pop Out as a New Technique for Lower Uterine Segment Support
Official title: Delivery of Fetal Head During Cesarean Section; Acceptability and Learning Curve of External Pop Out as a New Technique for Lower Uterine Segment Support; A Cross- Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section Complications
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: B. Eligible women who will present to the hospital and fulfill the inclusion criteria during the study period will be enrolled in the study.

Brief summary: Cesarean section represent the most significant operative intervention in all of obstetrics, its development and application have saved lives of countless mothers and infants. the frequency with which its carried out continues to rise and has in many hospitals and health regions reached rates in excess of 30%(


Eligibility criteria: Inclusion Criteria:

1. Singleton term pregnancy
2. Cephalic presentation
3. Women who will accept to participate in the study

Exclusion Criteria:

1. Non-cephalic presentation
2. Congenital fetal anomalies
3. Multiple pregnancy
4. Preterm caesarean \< 37 weeks
5. Cases with marked adhesions obscuring the lower uterine segment thickness

Primary outcomes:
measure: The number of cesarean sections that are required for the obstetrician to reach turning point .
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References:
Clinical trial NCT05105711: Mobile Coaching to Improve HPV Vaccine Delivery
Official title: Evaluating the Feasibility of a Mobile Coaching Intervention to Improve HPV Vaccine Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HPV Vaccine
Provider Communication Practices
Vaccine Recommendation Practices
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
name: University of Minnesota
name: National Cancer Institute (NCI)
First posted: 2021-11-03
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to examine the feasibility of using Checkup Coach, a mobile coaching intervention, to improve the way that primary care providers recommend HPV vaccination to adolescent patients and their parents. To conduct this feasibility study, the investigators will deliver the Checkup Coach intervention to 20 Kaiser Permanente Washington primary care providers who routinely recommend HPV vaccine to adolescent patients. The investigators will use a single-arm, pre-post design. Participating primary care providers will attend a 1-hour virtual communication workshop and then use a mobile phone app to receive additional coaching for 12 weeks. Providers will complete surveys at three time points: before the communication workshop, immediately after the workshop, and at 12-week follow-up. Surveys will assess changes in providers' self-reported HPV vaccine recommendation practices and beliefs about HPV vaccine and also acceptability of the intervention. The investigators hypothesizes that providers' HPV vaccine communication will improve between baseline and 12-week follow-up.


Eligibility criteria: Inclusion Criteria:

* Primary care providers who treat 11-12 year old adolescent patients in participating Kaiser Permanente Washington pediatric and family medicine practices

Exclusion Criteria:

* Primary care providers who do not treat adolescent patients

Primary outcomes:
measure: Change in HPV Vaccine Recommendation Quality Score
timeFrame: Baseline, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Kaiser Permanente Washington Health Research Institute
state: Washington
Study officials:
affiliation: University of North Carolina
name: Melissa B Gilkey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03885011: A Multi-Center, Double-Masked Evaluation of the Efficacy and Safety of CSF-1 in the Treatment of Presbyopia
Official title: A Multi-Center, Double-Masked Evaluation of the Efficacy and Safety of CSF-1 in the Treatment of Presbyopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Presbyopia
Lead sponsor: Orasis Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2019-03-21
Enrollment: 166
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 4-visit, multi-center, randomized, double-masked, parallel group study evaluating the safety and efficacy of CSF-1 in the treatment of presbyopia.

Detailed description: This is a 4-visit, multi-center, randomized, double-masked, parallel group study evaluating the safety and efficacy of CSF-1 in the treatment of presbyopia. Approximately 150 subjects will be enrolled across 7 study centers in the United States. At Visit 2, subjects will be randomized 1:1:1 to one of three treatment arms: CSF-1, CSF-1 Component #1, or CSF-1 Component #2. All subjects will dose twice a day in both eyes with a single drop of their assigned treatment for approximately 1 week. At Visit 3, subjects randomized to CSF-1 will now receive a different concentration of CSF-1, subjects randomized to CSF-1 Component #1 will receive a different concentration of CSF-1 Component #1 and subjects randomized to CSF-1 Component #2 will continue dosing with the same concentration of CSF-1 Component #2. All subjects will continue dosing twice a day in both eyes for approximately 1 week.

Eligibility criteria: Inclusion Criteria:

* Subjects must:

  1. Have presbyopia

Exclusion Criteria:

* Subjects must not:

  1. Have any contraindications to the study medications or diagnoses that would confound the study data

Primary outcomes:
measure: Number of Subjects With ≥ 3 Lines Gain in Near Best Distance Corrected Visual Acuity (BDCVA) (at 40 cm)
timeFrame: 1 hour post dose on day 8
measure: Number of Subjects With ≥ 3 Lines Gain in BDCVA (at 40 cm)
timeFrame: 1 hour post dose on day 15
Secondary outcomes:
measure: Number of Subjects With ≥ 2 Lines Gain in BDCVA (at 40 cm)
timeFrame: 1 hour post dose on day 8
measure: Number of Subjects With ≥ 2 Lines Gain in BDCVA (at 40 cm)
timeFrame: 1 hour post dose on day 15
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Orasis Investigative Site
state: California
city: Littleton
country: United States
facility: Orasis Investigative Site
state: Colorado
city: Andover
country: United States
facility: Orasis Investigative Site
state: Massachusetts
city: Bloomington
country: United States
facility: Orasis Investigative Site
state: Minnesota
city: Cranberry Township
country: United States
facility: Orasis Investigative Site
state: Pennsylvania
city: Memphis
country: United States
facility: Orasis Investigative Site
state: Tennessee
city: Draper
country: United States
facility: Orasis Investigative Site
state: Utah
Study officials:
References:
Clinical trial NCT05120011: Carnitine Supplementation and Bone Mineral Density
Official title: Effect of Carnitine Supplementation and Resistance Training on Bone Mineral Density
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Lead sponsor: Poznan University of Physical Education
Sponsor class: OTHER
Collaborators: name: Medical University of Gdansk
First posted: 2021-11-15
Enrollment: 36
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary aim of the current research project is to explore whether carnitine supplementation and resistance training may prevent decrements in bone mineral density of aged women.

A secondary aim of this project is to investigate the effect of supplementation on body composition and blood markers.

Detailed description: The study includes postmenopausal women. The subjects participate in resistance training (twice a week) for each session consisted of 6 exercises: horizontal seated leg press, seated chest press, leg extension, shoulder press, lat pull-down seated row, seated cable row.

During the 24-weeks training programme participants are supplemented by carnitine with leucine, or leucine alone (placebo).

Eligibility criteria: Inclusion Criteria:

* postmenopausal
* lack of restrictions to perform resistance exercises

Exclusion Criteria:

* cardiovascular disease
* liver disease
* kidney disease
* neuromuscular disease
* gastrointestinal disorders (including stomach ulcers and erosions)
* diabetes
* other severe chronic diseases

Primary outcomes:
measure: Bone Mineral Density measured by dual-energy X-ray absorptiometry (DXA)
timeFrame: 24 weeks
Secondary outcomes:
measure: Body Composition: Body Fat Mass, Fat Free Mass, and Skeletal Muscle Mass using a bioelectrical impedance analyzer (InBody720).
timeFrame: 24 weeks
measure: The circulating markers modification
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Akademia Wychowania Fizycznego
Study officials:
affiliation: Poznan University of Physical Education
name: Robert Olek, PhD
role: PRINCIPAL_INVESTIGATOR
References: