louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01952041: A New Paradigm for Illness Monitoring and Relapse Prevention in Schizophrenia
Official title: A New Paradigm for Illness Monitoring and Relapse Prevention in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
Schizoaffective Disorder
Mobile Application
Relapse
SMI
EHealth
E-Health
Health Technology
mHealth
m-Health
Mobile Health
Serious Mental Illness
Electronic Health
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2013-09-27
Enrollment: 149
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 was a 2-arm randomized control trial (RCT) designed to test a multi-modal smartphone data collection system that provided mobile monitoring of schizophrenia to detect early signs of relapse. The RCT compared an arm with participants who received treatment as usual with an arm that received the smartphone system for a year.


Eligibility criteria: Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria for schizophrenia, schizoaffective disorder, or psychosis not otherwise specified based on a chart diagnosis
* 18 years or older
* An inpatient psychiatric hospitalization, daytime psychiatric hospitalization, outpatient crisis management, or short-term psychiatric hospital emergency room within 12 months before study entry
* Willing and able to provide informed consent

Exclusion Criteria:

* Hearing, vision, or motor impairment that make it impossible to operate a smartphone (determined using a demonstration smartphone for screening)
* 6th grade reading level (determined by Wide Range Achievement Test- 4th Edition)

Primary outcomes:
measure: Relapses in Participants
timeFrame: 1 year
measure: Time to Relapse
timeFrame: From randomization date until first relapse (evaluated approximately every 3 months until their last study visit which occurred approximately 12 months from randomization for those who completed the study).
Secondary outcomes:
measure: Psychotic Symptom Severity
timeFrame: Assessed at baseline and every three months for one year.
measure: Depression
timeFrame: Assessed at baseline and every three months for one year.
measure: Social Functioning
timeFrame: Assessed at baseline and every three months for one year.
Other outcomes:
Locations:
city: Glen Oaks
country: United States
facility: Zucker Hillside Hospital
state: New York
Study officials:
affiliation: University of Washington
name: Dror Ben-Zeev, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00800241: Budesonide/Formoterol for Maintenance and Reliever Therapy Among Asthma Patients in Thailand
Official title: Budesonide/Formoterol for Maintenance and Reliever Therapy: A Medication Use Evaluation Among Persistent Asthma Patients in General Practice in Thailand
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma
Symbicort SMART
Thai patient eligibility
Persistent asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-12-02
Enrollment: 1020
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient aged 12 years or older who established persistent asthma and currently treated with Symbicort SMART for 3 months or longer.

Brief summary: The purpose of this study is to determine the incidence of misuse, i.e., over-use and under-use, of Budesonide/formoterol for maintenance and reliever therapy in usual-care setting.


Eligibility criteria: Inclusion Criteria:

* Established persistent asthma
* Currently treated with Symbicort SMART for 3 months or longer

Exclusion Criteria:

* currently participating or have participated in a study with an investigational compound within the last 30 days
* current diagnosis of chronic obstructive pulmonary disease (COPD)
* smoked more than 10 pack-year

Primary outcomes:
measure: Number of budesonide/formoterol use per patient
timeFrame: On the survey date
Secondary outcomes:
Other outcomes:
Locations:
city: Buriram
country: Thailand
facility: Research Site
city: Chanthaburi
country: Thailand
facility: Research Site
city: Chiang Mai
country: Thailand
facility: Research Site
city: Mahasarakham
country: Thailand
facility: Research Site
city: Nakhon Phanom
country: Thailand
facility: Research Site
city: Nakhon Srithammarat
country: Thailand
facility: Research Site
city: Nakhonpathom
country: Thailand
facility: Research Site
city: Phattalung
country: Thailand
facility: Research Site
city: Phitsanulok
country: Thailand
facility: Research Site
city: Rayong
country: Thailand
facility: Research Site
city: Roi Et
country: Thailand
facility: Research Site
city: Samutsakhon
country: Thailand
facility: Research Site
city: Surat Thani
country: Thailand
facility: Research Site
city: Trang
country: Thailand
facility: Research Site
Study officials:
affiliation: Department of Biostatistics and Demography, Faculty of Public Health, Khon Kaen University
name: Bandit Thinkhamrop, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Medicine, Faculty of Medicine, Khon Kaen University
name: Watchara Boonsawat, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03909841: Neuropathic Pain in Elderly People With Diabetes: Impact on Quality of Life and Cognition
Official title: Neuropathic Pain in Elderly People With Diabetes: Impact on Quality of Life and Cognition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Diabetic Peripheral Neuropathy
Cognitive Impairment
Quality of Life
Diabetic Peripheral Neuropathic Pain
Lead sponsor: Queen Elizabeth Hospital, Hong Kong
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with Diabetes Mellitus attending the diabetes clinic and / or pain clinic

Brief summary: This study was set out 1) Evaluate the impact of Diabetic Peripheral Neuropathy (DPN) and DPN-P (Diabetic Peripheral Neuropathic Pain) on the overall Quality of Life (QoL) in elderly with Diabetic Mellitus (DM) and 2) Evaluate the association between cognition impairments and DM in the elderly, and the contributions of DPN and/or DPN-P


Eligibility criteria: Inclusion Criteria:

* Aged 50 or above
* Diagnosis of diabetes mellitus (Type 1 or Type 2)

Exclusion Criteria:

* major psychiatric conditions
* recent cardiovascular events within the last six months
* blindness radiculopathy
* spinal cord injury, multiple sclerosis
* carpal tunnel syndrome
* trigeminal neuralgia
* Subjects who were incompetent in giving written consent

Primary outcomes:
measure: Cognition
timeFrame: Day 1
Secondary outcomes:
measure: Quality of Life: The Chinese (Hong Kong) 12-item Short-Form Health Survey version 2
timeFrame: Day 1
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: Queen Elizabeth Hospital
Study officials:
affiliation: Research Ethics Committee (Kowloon Central/ Kowloon East)
name: Research Ethics Committee (Kowloon Central/ Kowloon East)
role: STUDY_CHAIR
References:
Clinical trial NCT06482619: Effects of Creatine and Rehabilitation Programin Athletes With Patellar Tendinopathy
Official title: Effects of Creatine Supplementation in Combination With a Rehabilitation Program Physical in Athletes With Patellar Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Creatine
Patellar Tendinopathy
Keywords: Ergogenic aid
Dietary
Injury
Nutrition
Sport Nutrition
Lead sponsor: Universidad Pontificia Comillas
Sponsor class: OTHER
Collaborators: name: Universidad de Córdoba
name: University of Bologna
name: Technical University of Madrid
name: Lavras University
First posted: 2024-07-01
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study are to analyze the effect of creatine ingestion in pain, histological properties of the tendon, body composition, strength and vertical jump performance in athletes with patellar tendinopathy that follow a physical rehabilitation program that include eccentric exercise combined with stretching and extracorporeal shock wave therapy.

Detailed description: Nutrition could play an important role in the rehabilitation from sport injuries. This afirmation is based on studies that analyze the impact of different dietary supplements along immobilization periods, stablishing that creatine, leucine and omega-3 fatty acid supplementation could ameliorate muscle loss, while creatine could potentiate the hypertrophy along the rehabilitation process. For this reason, the aim of this study are to analyze the effect of creatine ingestion in pain, histological properties of the tendon, body composition, strength and vertical jump performance in athletes with patellar tendinopathy that follow a physical rehabilitation program that include eccentric exercise combined with stretching and extracorporeal shock wave therapy.

Eligibility criteria: Inclusion Criteria:

* Athletes diagnosed with patellar tendinopathy by sport medicine doctor.
* Age (\>18 years and \<49 years).
* To be federated in a sport modality that involves high repetitive impact in the knee; iii) to train more than 3 sessions weekly.
* Not having undergone knee surgery.
* Not having undergone any infiltration of analgesics or platelet-rich plasma during the last year.
* Not intake any sport performance supplement in the previous year;
* Smoker person.

Exclusion Criteria:

* Not being diagnosed with patellar tendinopathy by a doctor
* Age (\<18 years and \> 50 years).
* Involved in a sport modality without high repetitive impacts during sports activity.

Primary outcomes:
measure: Pain evaluation
timeFrame: 8-weeks
measure: Tendon thickness.
timeFrame: 8-weeks
Secondary outcomes:
measure: Neuromuscular function
timeFrame: 8-weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Pontificia Comillas
Study officials:
affiliation: Universidad de Córdoba
name: Angela Sánchez-Gómez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03418519: A Comparative Analysis on Physical Activity Performance and Motor Function of Affected Upper Extremity Before and After a CIMT Program in Young Children With Hemiparetic Cerebral Palsy
Official title: A Comparative Analysis on Physical Activity Performance and Motor Function of Affected Upper Extremity Before and After a CIMT Program in Young Children With Hemiparetic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemiplegic Cerebral Palsy With Spasticity (Diagnosis)
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-02-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates CIMT(Constraint Induced Movement Therapy) in the treatment of physical activity performance and motor function of the weaker extremity in young children with cerebral palsy. Half of participants will receive CIMT while the other half will receive no treatment.

Detailed description: Constraint-induced movement therapy (CIMT) is a short-term, intensive treatment to promote functional arm and hand skills in people with hemiparesis. It usually involves constraint of the non-involved extremity and intensive movement practice of the weaker extremity.

Eligibility criteria: Inclusion Criteria:

* diagnosed with spastic hemiplegic cerebral palsy
* age between 18 months and 36 months
* Mini-MACS level 1-4

Exclusion Criteria:

* botox injection in upper extremity within 6 months
* poor cooperation with cognitive impairment
* any musculoskeletal disease
* visual or hearing impairment
* uncontrollable epilepsy
* skin damage that makes impossible for participant to wear a splint
* Mini-MACS level 5

Primary outcomes:
measure: Accelerometers(physical activity performance)
timeFrame: 3 days
measure: Pediatric Motor Activity Log(PMAL)
timeFrame: 30 minutes
Secondary outcomes:
measure: Pediatric Evaluation of Disability Inventory(PEDI)
timeFrame: 30 minutes
measure: Peabody Developmental Motor Scales-2(PDMS-2)
timeFrame: 30 minutes
measure: Gross motor function measure - 66(GMFM-66)
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
citation: Hwang YS, Kwon JY. Effects of Modified Constraint-Induced Movement Therapy in Real-World Arm Use in Young Children with Unilateral Cerebral Palsy: A Single-Blind Randomized Trial. Neuropediatrics. 2020 Aug;51(4):259-266. doi: 10.1055/s-0040-1702220. Epub 2020 Mar 6.
Clinical trial NCT01033019: To Evaluate the Safety, Local Tolerability, PK and PD of LDE225 on Sporadic Superficial and Nodular Skin Basal Cell Carcinomas (sBCC)
Official title: Double-blind, Randomized, Vehicle-controlled Proof of Concept Study on the Efficacy, Safety, Local Tolerability, PK and Pharmacodynamics of Multiple Topical Administrations of LDE225 on Sporadic Superficial and Nodular Skin Basal Cell Carcinomas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Sporadic Superficial and Nodular Skin Basal Cell Carcinomas
Keywords: Basal cell carcinomas,
sporadic,
superficial and nodular,
skin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-12-16
Enrollment: 25
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: This was a double-blinded, randomized, vehicle-controlled study in sporadic superficial BCC (sBCC) and nodular BCC (nBCC) patients which consisted of a 21-day screening period, a treatment period of 6 weeks (topical 0.75% LDE225 cream application b.i.d) ending with post treatment biopsies, as safety visit one week after final study drug administration (Day 50), a visit on Day 83 for excision of the treated BCC, and an end of study evaluation (Day 90).


Eligibility criteria: Inclusion Criteria:

* Patients with one histologically confirmed superficial and nodular basal cell carcinoma (8-20 mm) eligible for surgical excision on selected body areas (scalp, arm, frontal trunk, posterior trunk, upper legs)

Exclusion Criteria:

* Previous treatment of the sBCC that are selected for treatment.
* Any systemic treatment which is known to affect BCCs esp. cytostatic treatments, retinoids and photodynamic treatments.
* Dark-skinned persons whose skin color prevents readily assessment of skin reactions

Other protocol defined Incl./Excl. criteria may apply.

Primary outcomes:
measure: Clinical Evaluation of sBCCs Tumors
timeFrame: Day 43
Secondary outcomes:
Other outcomes:
Locations:
city: Benowa
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Woolloongabba
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT03308019: Adjunct Photodynamic Therapy in Chronic Periodontitis Among Cigarette-smokers.
Official title: Effectiveness of Scaling and Root Planing With and Without Adjunct Antimicrobial Photodynamic Therapy in the Treatment of Chronic Periodontitis Among Cigarette-smokers and Never-smokers: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Smoking
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2017-10-12
Enrollment: 83
Sex: MALE
Minimum age (years): 42
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of scaling and root planing with and without adjunct antimicrobial photodynamic therapy (aPDT) in the treatment of chronic periodontitis (CP) among cigarette-smokers and never-smokers.

Detailed description: The following inclusion criteria were entailed: (a) Self-reported habitual cigarette-smokers; (b) self-reported never-smokers; (c) patients with CP (presence of at least 30% sites with ≥ 3 mm of CAL and PD ≥ 3 mm 18, 19 ). The exclusion criteria were as follows: (a) patients with systemic diseases such as acquired immune deficiency syndrome/HIV and diabetes mellitus; (b) habitual smokeless tobacco product and alcohol users; (c) third molars and fractured teeth with embedded root remnants and edentulous individuals; (d) patients with misaligned teeth; and (e) patients that reported to have used antibiotics, non-steroidal anti-inflammatory drugs and/or steroids within the past 90 days.

Demographic information was collected using a questionnaire. Cigarette-smokers (group-1) and never-smokers (group-2) with chronic periodontitis were included. Treatment wise, these individuals were divided into two subgroups as follows: (a) SRP alone and (b) SRP with adjunct aPDT. Periodontal parameters (plaque index \[PI\], bleeding on probing \[BOP\], clinical attachment loss \[CAL\] and probing pocket depth ≥4mm \[PD\] were measured at baseline and at 1 month and 3 months' follow-up.

Eligibility criteria: Inclusion Criteria:

* Self-reported habitual cigarette-smokers.
* Self-reported never-smokers.
* Patients with chronic periodontitis (presence of at least 30% sites with ≥ 3 mm of CAL and PD ≥ 3 mm.

Exclusion Criteria:

* Patients with systemic diseases such as acquired immune deficiency syndrome/HIV and diabetes mellitus.
* Habitual smokeless tobacco product and alcohol users.
* Third molars and fractured teeth with embedded root remnants and edentulous individuals.
* Patients with misaligned teeth.
* Patients that reported to have used antibiotics, non-steroidal anti-inflammatory drugs and/or steroids within the past 90 days.

Primary outcomes:
measure: Probing depth
timeFrame: 3 months
measure: Clinical attachment level gain
timeFrame: 3 months
Secondary outcomes:
measure: Plaque index
timeFrame: 3 months
measure: Bleeding on probing
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06920719: Bioequivalence Study betweenYHP2406 and YHR2501 in Healthy Subjects
Official title: An Open-label, Randomized, Fasting, Single-dose, Oral Administration, 2- Sequence, 2-period, Crossover Study to Evaluate Bioequivalence Study Between YHP2406 and YHR2501 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Subject
Keywords: Pharmacokinetics
Bioequivalence
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2025-04-10
Enrollment: 62
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2406 and YHR2501 in healthy volunteers

Detailed description: 62 healthy subjects will be randomized to one of the 2 groups in the same ratio.

Subjects in group 1 will be administered "comparator" and "YHP2406" by crossover design on period 1, 2. Subjects in group 2 will be administered "YHP2406" and "comparator" by crossover design on period 1, 2.

Eligibility criteria: Inclusion Criteria:

* BMI 18-30 kg/m2
* Those without clinically significant congenital or chronic diseases

Exclusion Criteria:

* Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational products in 6 months prior to the first administration.
* Others who are judged ineligible to participate in the trial by the principal investigator.
* Female volunteers who are pregnant, suspected to be pregnant or breastfeeding.

Primary outcomes:
measure: Area under the plasma drug concentration-time curve [AUCt]
timeFrame: 0-8 hours
measure: Maximum plasma concentration [Cmax]
timeFrame: 0-8 hours
Secondary outcomes:
measure: Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]
timeFrame: 0-8 Hours
measure: Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]
timeFrame: 0-8 Hours
measure: Time of peak concentration [Tmax]
timeFrame: 0-8 Hours
measure: Terminal phase of half-life [t1/2]
timeFrame: 0-8 Hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus Yangji Hospital
Study officials:
affiliation: H Plus Yangji Hospital
name: Seoung Hyun Kang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06405919: Risk of Malignancy in Endemic Long Standing Nodular Goitres: a Prospective Cohort Study
Official title: Risk of Malignancy in Endemic Long Standing Nodular Goitres: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incidence of Thyroid Cancer in Long Standing MNG
Keywords: : goitre, long standing, malignant risk, incidental.
Lead sponsor: University of Khartoum
Sponsor class: OTHER
Collaborators: name: Sudan Medical Specialization Board
First posted: 2024-05-09
Enrollment: 160
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: Patients with long standing goitres presenting for surgery in Khartoum Teaching Hospital March 2017-September 2018

Brief summary: To determine the incidence of thyroid cancer in patients with long standing goitres presenting for surgery.

Detailed description: This is a prospective cohort study The objective is to determine the incidence of cancer in patients with long standing goitres( more than 10 years ) who present for surgery in Khartoum Teaching Hopspital - Sudan.

Introduction: goitre is endemic in Sudan with prevalence ranging between 5-42% in different regions of the country. Patients are referred for surgery only if they develop pressure symptoms.

The incidence of thyroid carcinoma is high in endemic goitrous areas. Determining the risk of cancer in patient with long standing goitres may help in early early referral and early surgical intervention.

Methods: This is prospective cohort study including 160 patients with long standing goitrers of 10 years or more who presented from March 2017 to September 2017 to Khartoum Teaching Hospital-Sudan

Eligibility criteria: Inclusion Criteria:

* All patients with long standing goitres of 10 years or more

Exclusion Criteria:

* Non

Primary outcomes:
measure: Rate of malignancy
timeFrame: March 2017-September 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Khartoum
country: Sudan
facility: Faculty of Medicine University of Khartoum
Study officials:
affiliation: University of Khartoum -Faculty of Medicine
name: Mohamed Elmakki Abdella, MS,FRCSI
role: STUDY_DIRECTOR
References: