louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06739733: Effectiveness of Soft Robotic Glove Versus EMS on Hand Function and Quality of Life in Stroke Survivors (RCT)
Official title: Effectiveness of Soft Robotic Glove Versus EMS on Hand Function and Quality of Life in Stroke Survivors. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will evaluate the effectiveness of soft robotic gloves versus electrical muscle stimulation (EMS) in improving hand function and quality of life in stroke survivors. Stroke often leads to impaired hand mobility, impacting daily activities and reducing overall quality of life. Soft robotic gloves, designed to assist with hand movement, will provide mechanical support and encourage voluntary muscle activity. EMS, on the other hand, will stimulate muscle contraction through electrical impulses, potentially enhancing muscle strength and coordination.

Detailed description: Participants will be divided into two groups: one will receive treatment using soft robotic gloves, and the other with EMS. Outcomes will be assessed using standardized hand function tests and quality-of-life questionnaires over a specified period. Results are expected to indicate that both interventions will improve hand function and quality of life, with the robotic gloves showing a marginally greater improvement in dexterity and grip strength, while EMS will yield benefits in muscle reactivation and endurance. Stroke survivors in the robotic glove group are anticipated to report greater ease in performing daily tasks, while the EMS group will note an increase in muscle engagement.

Eligibility criteria: Inclusion Criteria:

* Had ischemic or hemorrhagic stroke ≤6 months.
* Mini-mental status exam scores \> 24(7).
* GCS score 11 to 15(2)
* FMA-UE score \< 21(3)

Exclusion Criteria:

* Participants with severe vision or hearing impairment.
* Neurological disorders including epilepsy, Alzheimer's disease, vertigo, Parkinson disease, and , muscular disorders which limit functional activity (OA, RA, etc).
* Peripheral vestibular disorder.
* Medications that affect balance, severe cardiovascular conditions, recent lower limb injury or surgery.
* Contraindications for EMS: Patients with certain medical conditions, such as pacemakers, implantable cardioverter-defibrillators, or metal fragments in their body, that contraindicated the use of EMS were excluded.

Primary outcomes:
measure: The Fugl-Meyer Upper Extremity Assessment (FMA-UE)
timeFrame: 12 Months
measure: The Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Ahmad block garden town canal road
state: Punjab
Study officials:
References:
Clinical trial NCT00527033: A Study of YM178 in Patients With Symptomatic Overactive Bladder
Official title: A Randomized, Double-blind, Parallel-group, Placebo-controlled Study in Patients With Symptomatic Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Bladder, Overactive
Keywords: YM178
Urinary Bladder, Overactive
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-09-10
Enrollment: 842
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: Examine which dose of YM178 is the best in terms of efficacy, safety and tolerability compared to placebo

Detailed description: To investigate the dose-response relationship of YM178 in terms of efficacy, safety and tolerability, and also the superiority of YM178 over placebo.

Eligibility criteria: Inclusion Criteria:

* Patients over 20 years suffering from overactive bladder

Exclusion Criteria:

* Pregnant and breastfeeding women
* Any clinically significant abnormal conditions which in the opinion of the investigator makes the patient unsuitable for the study

Primary outcomes:
measure: Overactive bladder symptoms
timeFrame: 12 weeks
Secondary outcomes:
measure: Overactive bladder symptoms (QOL)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kanto
country: Japan
city: Kyusyu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_CHAIR
References:
citation: Yamaguchi O, Marui E, Igawa Y, Takeda M, Nishizawa O, Ikeda Y, Ohkawa S. Efficacy and Safety of the Selective beta3 -Adrenoceptor Agonist Mirabegron in Japanese Patients with Overactive Bladder: A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study. Low Urin Tract Symptoms. 2015 May;7(2):84-92. doi: 10.1111/luts.12053. Epub 2014 Mar 11.
Clinical trial NCT05118633: Technology Assisted Treatment for Trichotillomania
Official title: Technology Assisted Treatment for Trichotillomania
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trichotillomania
Keywords: Hair Pulling Disorder
Body-Focused Repetitive Behaviors
Trichotillomania
Lead sponsor: HabitAware Inc.
Sponsor class: INDUSTRY
Collaborators: name: Kent State University
First posted: 2021-11-12
Enrollment: 70
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: Trichotillomania is characterized by recurrent hair pulling resulting in hair loss causing significant distress and impairment which persists despite repeated attempts to stop. Behavioral based therapies focused on increasing awareness of hair pulling followed by the use of an incompatible behavior have proven effective. In an effort to enhance awareness, a wrist worn motion detection device and a companion mobile application was created. In this study, we will test the initial efficacy of the HabitAware device and accompanying app as a system for delivering self-administered habit reversal training (HRT).


Eligibility criteria: Inclusion Criteria:

* Willingness to participate;
* Current diagnosis of TTM (as assessed via TDI);
* Regular access to a smartphone with GPS capabilities (i.e., available for completing assessment probes throughout the day);

Exclusion Criteria:

* Currently receiving psychotherapy
* Other psychiatric condition requiring more immediate care
* Have previously used any behavior awareness devices (e.g. Keen)

Primary outcomes:
measure: Improvement in clinical symptoms amongst participants
timeFrame: Eight weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00400933: Evaluation of a Six-session Psycho-education Group Program
Official title: Evaluation of a Six-session Psycho-education Group Program Delivered to Family Members and Close Friends of Patients Suffering From Eating Disorders and Co-morbid Personality Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Eating Disorders
Personality Disorders
Keywords: Psycho-education
Eating disorders
Personality disorders
Relatives and close friends
Caregiver burden
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: The Royal Norwegian Ministry of Health
First posted: 2006-11-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this project is to analyze the impact of a psycho-educational group program on the family members and close friends of persons with eating disorders and co-morbid personality disorders.

Detailed description: The aim of this project is to analyze the impact of a six session psycho-educational group program on the family members and close friends of persons with eating disorders and co-morbid personality disorders.

Measurements: General health, perceived caregiver burden, and relation to the patient at the following point of time: pre -, post- and follow up, with waiting list control.

Eligibility criteria: Inclusion Criteria:

* Relatives and close friends to persons receiving treatment for their eating disorder and comorbid personality disorder.
* \> 18 years,
* Speak and understand norwegian language, and
* Informed consent to participate for both relative and patient.

Primary outcomes:
measure: Scores on perceived caregiver burden (Experience of Caregiving Inventory [ECI])
timeFrame: 1 year
Secondary outcomes:
measure: Scores on general health and relational variables
timeFrame: 1 year
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Østmarka Psychiatric Department, St Olavs Hospital, University Hospital of Trondheim
Study officials:
affiliation: Norwegian University of Science and Technology
name: Are Holen, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04993833: Inter-Device Reliability of the NPi-300 Pupillometer
Official title: Inter-Device Reliability of the NPi-300 Pupillometer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Neuropathy
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: NeurOptics Inc.
First posted: 2021-08-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient Cohort: Patients admitted with a neurological or neurosurgical diagnosis that place them at risk for cerebral edema.

Healthy Cohort: Faculty/Staff who interact with patients at the enrolling site

Brief summary: The purpose of this study is to explore the inter-device reliability between the NPi-200 and NPi-300.

Detailed description: Paired assessments will be made on patients who are consented; and on healthy controls who have verbally assented to participate. We plan to enroll 20 patients and 50 healthy controls. Assessments will be made at the convenience of the patient and healthy controls. Each assessment will include bilateral PLR reading within a 5 minute interval. The first assessment will be completed with the NPi-200 and the second assessment will use the NPi-300. The data will be entered into a CRF.

If there is a significant difference between readings from the NPi-200 and the NPi-300, we will repeat the bilateral assessment in the following hour and the regularly scheduled time.

Eligibility criteria: Inclusion Criteria (Patient Cohort):

* Subjects will be included if they are adults (\>18 years of age) and have a neurological or neurosurgical diagnosis that place them at risk for cerebral edema. Subjects also have to be admitted to the enrolling site. Persons consenting for the study (whether patient or LAR) will need to be able to consent for the study in English.

Exclusion Criteria (Patient Cohort):

* Patients that will be excluded from the study are those that are prisoners, under 18 years of age, or pregnant women.

Inclusion Criteria (Healthy Control Cohort):

* Staff in the enrolling site

Exclusion Criteria (Healthy Control Cohort):

* None

Primary outcomes:
measure: Pupil's reaction to light as measured by Neurological Pupil Index (NPI)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Clements University Hospital
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: DaiWai M Olson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01061333: Early Airway Response to Allergen in Asthmatics (MK-0000-176)
Official title: A Two-Part, Randomized, Placebo-Controlled, Crossover Trial to Evaluate the Differential Effects of Inhaled Nedocromil, Oral Montelukast, and Inhaled Mometasone on Markers of the Early Airway Response to Allergen in Asthmatics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-02-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will assess the Early Airway Response (EAR) associated change in forced expiratory volume in one second (FEV1) and plasma 9α-11ß-PGF2 ('9P') after single dose pretreatment of nedocromil, montelukast, and mometasone.


Eligibility criteria: Inclusion Criteria:

* History of mild to moderate Asthma
* In good general health (except for asthma)
* Stable and free of respiratory infection
* Nonsmoker
* Females highly unlikely to conceive (surgically sterilized, postmenopausal, or agrees to use 2 acceptable methods of birth control)

Exclusion Criteria:

* Nursing mother
* Recent or ongoing upper or lower respiratory tract infection
* Unable to refrain from or anticipates the use of any prescription and non-prescription drugs
* Consumes excessive amounts of alcohol or caffeine
* History of stroke, chronic seizures, or major neurological disorder
* History of cancer
* Received a vaccination within the past 3 weeks

Primary outcomes:
measure: Change in Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Pre-allergen challenge and 20 minutes after allergen challenge
measure: Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes
timeFrame: Pre-allergen challenge and 5 minutes post allergen challenge
measure: Change in Plasma 9P at 20 Minutes
timeFrame: Pre-allergen challenge and 20 minutes post allergen challenge
Secondary outcomes:
measure: Allergen-induced Changes in Urinary 9P
timeFrame: Baseline and 2 hours post allergen challenge
measure: Allergen-induced Changes in Urinary Leukotriene (LT) E4
timeFrame: Baseline and 2 hours post allergen challenge
measure: Allergen-induced Concentrations of Sputum LTC4
timeFrame: 2 hours post allergen challenge
measure: Allergen-induced Concentrations of Sputum LTD4
timeFrame: 2 hours post allergen challenge
measure: Allergen-induced Concentrations of Sputum LTE4
timeFrame: 2 hours post allergen challenge
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05385133: Condyle Repositioning Using PSI and Prebent Plates Osteosynthesis Versus Conventional Mandibular BSSO Set-back Surgery
Official title: Condyle Repositioning Using Patient Specific Guides and Prebent Plates Osteosynthesis Versus Conventional Mandibular Bilateral Sagittal Split Osteotomy Set-back Surgery: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthognathic Surgery
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 20
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with skeletal class III malocclusion were allocated to two groups. Both proximal and distal segments were repositioned using osteotomy/screw holes and plate locating surgical guides with pre-bent plates osteosynthesis in the intervention group, while manual free hand condylar segment seating was used for proximal segment positioning in the control group.

Detailed description: Twenty patients with skeletal class III malocclusion were randomly allocated to two groups. Both proximal and distal segments were repositioned using osteotomy/screw holes and plate locating surgical guides with pre-bent plates osteosynthesis in the intervention group, while manual free hand condylar segment seating was used for proximal segment positioning in the control group. Accuracy of condylar position was assessed using computed tomography.

Eligibility criteria: Inclusion Criteria:

* Adult patients complaining of skeletal class III malocclusion that require BSSO for correction of their deformity

Exclusion Criteria:

* Patients require bi-maxillary orthognathic surgery
* patients with temporomandibular joint dysfunction

Primary outcomes:
measure: Condylar deviation
timeFrame: 1 week postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
Clinical trial NCT05204433: Correlation Between SFRP1 and Colorectal Cancer and Adenoma
Official title: Correlation Between Methylation Site of SFRP1 Gene Promoter and Colorectal Cancer and Adenoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Early Diagnosis of Colorectal Cancer and Adenoma
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: consecutive adult patients undergoing an outpatient endoscopy

Brief summary: In summary, our study demonstrated the methylation sites of SFRP1 gene promoter in patients with colorectal cancer and adenoma and found SFRP1_16_17_18 CpG site was good performance as a diagnostic marker of colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* consecutive adult patients undergoing an outpatient endoscopy and histopathologically diagnosed as colorectal cancer or adenoma. Also, healthy individuals were invited to be enrolled.

Exclusion Criteria:

* Lynch syndrome
* Familial adenomatous polyposis
* MUTYH associated polyposis
* Peutz-Jeghers syndrome
* Juvenile polyposis syndrome
* Serrated polyposis syndrome

Primary outcomes:
measure: effectiveness of methylation markers from stool samples
timeFrame: 3 years
Secondary outcomes:
measure: assess the capacities of RF model in screening potential clinical biomarkers.
timeFrame: 3 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Jie Liang
state: Shaanxi
Study officials:
References:
Clinical trial NCT00523133: Research on Individualized Treatment for Alcoholism
Official title: Posttreatment Effects of Naltrexone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Dependence
Keywords: alcoholism
naltrexone
motivational enhancement therapy
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: VA Boston Healthcare System
name: Brown University
name: George Washington University
First posted: 2007-08-31
Enrollment: 185
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the effects of two psychosocial treatments that differed in scope and intensity (Broad Spectrum Treatment and Motivational Enhancement Treatment) combined with 3 or 6 months of treatment with naltrexone on alcohol drinking behaviors in alcohol dependent patients.


Eligibility criteria: Inclusion Criteria:

* men and women between the ages of 21-65
* current DSM-IV diagnosis of alcohol dependence
* abstinent for a minimum of 3 and maximum of 21 days prior to treatment initiation
* able to participate in an 18-month outpatient study
* live within a one hour or less commute to Fairbanks
* fluent in English
* women of child-bearing potential must have a negative pregnancy test and use effective contraceptive methods.
* score as contemplators or greater on the Readiness For Change Scale

Exclusion Criteria:

* severe hepatic disease (gGGT, SGOT or other liver functions greater than 4 times normal)
* opiate use (for any reason) in the last 14 days or a history of opioid dependence in the past year
* pregnant or lactating females or those unwilling to use birth control
* inability, according to the opinion of the interviewer, to follow medication instructions and safety precautions
* comorbid substance dependence (but not abuse) diagnosis in the past 6 months, excluding nicotine or marijuana dependence
* concomitant use of medications intended to decrease drinking (e.g. disulfiram)
* meeting current DSM criteria for bipolar disorder, schizophrenia, bulimia/anorexia, dementia, major depression

Primary outcomes:
measure: Percent Days Abstinent
timeFrame: 18 months
Secondary outcomes:
measure: Percent Heavy Drinking Days
timeFrame: 18 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: University Hospital, Psychiatry Outpatient Clinic
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Dena Davidson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04763733: Laparoscopic Splenectomy in Children
Official title: Prognostic Scoring System of Laparoscopic Splenectomy in Children With Benign Hematological Diseases.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Laparoscopic Splenectomy
Children
Benign Blood Diseases
Keywords: laparoscopic splenectomy,
children
prognostic score
benign hematological diseases
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 137
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Laparoscopic splenectomy (LS) gained popularity since it has been described for the first-time during nineties of past century. It has become "golden method" for splenectomy in all ages including children

Detailed description: Background: laparoscopic splenectomy (LS) gained popularity during the last years in pediatric age group. Benign hematological diseases represent the main indications of that procedure. There are some score systems of difficulty of the technique but they are for adult patients. The aim is to develop a prognostic score system of LS in children with benign hematological diseases.

Methods: LS was performed in all children with benign hematological diseases. LS was done by the same team. They operated children in lateral decubitus position. The control of pedicle was achieved using bipolar sealing devices, polymer clips or endoscopic linear staplers. Preoperative, operative, and postoperative data were recorded and analyzed. Children were divided into two groups A and B according to the development of complications.

Eligibility criteria: Inclusion Criteria:

* children with benign hematological diseases

Exclusion Criteria:

* malignant hematological diseases

Primary outcomes:
measure: prognosis of procedure
timeFrame: from day 0 to 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: