louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03864809: • Sleep Disturbance Among Patients With Psoriasis and Atopy and Comparison Between Them
Official title: • Sleep Disturbance Among Patients With Psoriasis and Atopy and Comparison Between Them
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Disturbance
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study involves the use of seven questionnaires to be given to subjects with psoriasis and a topic dermatites

Brief summary: Comparison between sleep disturbance in atopy and psoriasis and control

Detailed description: Sleep is essential for daytime functioning and health and important for both psychological and physiological wellbeing . A growing body of research indicates that chronic sleep disturbance is associated with impaired quality of life (QoL) and a risk factor for poorer health, for example depression cardiovascular disease, hypertension 1 and diabetes.

insomnia, the most common sleep disorder, is a clinical condition defined as difficulties falling asleep and/or maintaining sleep and/or poor sleep quality despite adequate opportunity for sleep resulting in significant daytime impairment.

The development of insomnia in healthy populations has a bi-directional relationship with psychological factors such as anxiety, depressive symptoms and stress, and may in clinical populations also be associated with physical symptoms, such as pain. the physical symptoms in psoriasis, such as itch, one would expect a higher prevalence of sleep disturbance in this patient group. On the other hand Sleep disturbance is common also in patients with atopic dermatitis (AD). Patients with AD often have sleep disturbances due to pruritus.

Eligibility criteria: Inclusion Criteria:

- patients with Psoriasis and Patients with A topic dermatitis

Exclusion Criteria:

* All patient have another dermatological disease

Primary outcomes:
measure: severity of the psooriasis (Psoriasis Area and Severity Index)
timeFrame: 1 hour
Secondary outcomes:
measure: 2.HRQoL (Dermatology Life Quality Index);
timeFrame: 1 hour
measure: .insomnia severity [Insomnia Severity Index (ISI)];
timeFrame: 1 hour
measure: sleep quality [Pittsburgh Sleep Quality Index (PSQI)];
timeFrame: 1 hour
measure: stress (Perceived Stress Scale);
timeFrame: 1 hour
measure: itch (Itch Severity Scale);
timeFrame: 1 hour
measure: and depressive symptoms (Beck Depression Inventory
timeFrame: 1 hour
measure: severity of a topic dermatitis
timeFrame: 1 hour
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: radwa bakr, lecturer
role: STUDY_DIRECTOR
References:
citation: Jensen P, Zachariae C, Skov L, Zachariae R. Sleep disturbance in psoriasis: a case-controlled study. Br J Dermatol. 2018 Dec;179(6):1376-1384. doi: 10.1111/bjd.16702. Epub 2018 Aug 23.
Clinical trial NCT06069609: Orientation Characteristics of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Acuvue Oasys 1-Day for Astigmatism Contact Lenses
Official title: Orientation Characteristics of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Acuvue Oasys 1-Day for Astigmatism Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2023-10-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Approximately 30 soft toric contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double-masked (subject and investigator), repeated measures insertion study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria, subjects will be dispensed study lenses according to unique randomization tables that will be provided to each Investigator. If study eligibility is met, subjects will have lenses inserted in random, successive order. Subjects will be receiving each of the study lens types once, in a randomized order. The subject will wear each of the study contact lenses for approximately 10 minutes.


Eligibility criteria: Inclusion Criteria:

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
3. Have no active ocular disease or allergic conjunctivitis
4. Not be using any topical ocular medications.
5. Be willing and able to follow instructions.
6. Have signed a statement of informed consent.

Exclusion Criteria:

The subject is not eligible to participate in the study if the subject is:

1. Participating in a conflicting study in the opinion of the Investigator.
2. Considered by the Investigator to not be a suitable candidate for participation.

Primary outcomes:
measure: Primary gaze orientation for 5 minutes
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb, Incorporated
state: New York
Study officials:
References:
Clinical trial NCT02723409: Trial of Techniques for Umbilical Reconstruction
Official title: Umbilicoplasty: A Randomized Controlled Trial of Techniques for Umbilical Reconstruction Following Abdominoplasty and Abdominally-based Free Tissue Transfer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Umbilicoplasty
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-03-30
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The primary objective of the study will be to determine which of five traditionally used umbilical reconstructive techniques offers superior aesthetic results. Additionally, secondary objectives of post-operative complications such as hypertrophic scar formation will also be measured.

Detailed description: This is a five arm, prospective, randomized, trial. Patients undergoing abdominoplasty or abdominally-based free tissue transfer (TRAM/DIEP flaps) at NYU Medical Center will be randomly assigned to receive one of five conventionally used umbilicoplasty techniques during the course of their surgery:

1. Round procedure
2. "Scarless" round procedure
3. "Inverted u" procedure
4. "Inverted v" procedure, and
5. "Y deepithelialized" procedure

As there has not yet been a superiority or inferiority comparison of these five methods, no patient will be receiving substandard care by randomization to one of the five procedures.

Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent Form
* Female patients undergoing abdominoplasty or abdominally-based free tissue transfer (TRAM/DIEP flaps)

Exclusion Criteria:

* Patients with prior history of umbilicoplasty
* History of keloid formation
* Active smokers
* Body Mass Index (BMI) over 40

Primary outcomes:
measure: Change in measurement of patient assessment post-operative and pre-operative, using a VAS survey results with a positive result indicating a favorable outcome
timeFrame: Baseline, 12 Weeks
measure: Assessment of inter-rater reliability among physicians in the assessment of the aesthetic outcomes of umbilical reconstruction.
timeFrame: 12 Weeks
measure: Comparison of aesthetic outcomes of umbilical reconstruction using five accepted techniques for umbilicoplasty following abdominoplasty or abdominally-based free tissue transfer (TRAM/DIEP flaps).
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: VIshal Thanik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01142609: Improving Substance Abuse Counseling Adherence Using Web-based Videoconferencing
Official title: Improving Substance Abuse Counseling Adherence Using Web-based Videoconferencing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse Disorder
Keywords: Web based videoconferencing
methadone
substance abuse counseling
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-06-11
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This research is being done to compare the effectiveness of standard on-site, in-person counseling with Internet web-based videoconferencing (e-therapy) in drug-dependent patients in opioid-agonist treatment programs. The study is looking to see if there are any differences in satisfaction or in treatment outcome if counseling sessions are given by e-therapy compared to standard, in-person counseling given in the clinic. The e-therapy happens in real time- it works very much like standard therapy in the clinic except that the patient is in his or her own home (or other convenient location outside the clinic) and talks to and sees the therapist through an Internet connection on the computer (the therapist will usually be at the clinic).

Detailed description: This study will be the first to evaluate the efficacy of an accredited and currently available, Internet web-based videoconferencing platform to deliver routine schedules of counseling in an opioid agonist treatment program. It has outstanding potential to help determine transportability of this technology to other treatment programs by demonstrating the benefits of integration of web-based therapy with on-site services to expand the continuum of care.

Eligibility criteria: Inclusion Criteria:

* Access to a computer with Internet capability
* Full adherence to their routine counseling schedule over the previous 30-days
* Negative urine specimens over the previous 30-days
* Patient at ATS for 90 days

Exclusion Criteria:

* No access to a computer with Internet capability

Primary outcomes:
measure: Counseling efficacy
timeFrame: Weekly for 12 weeks
measure: Reinforcement value (eGetgoing)
timeFrame: Monthly for 3 months
measure: Reinforcement value (on-site)
timeFrame: Baseline
Secondary outcomes:
measure: Program Satisfaction
timeFrame: Baseline and monthly for 3 months
measure: Treatment cost
timeFrame: Baseline and Month 3
measure: Therapeutic relationship
timeFrame: Baseline and monthly for 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Addiction Treatment Services
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Van King, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04794309: Outcomes of Circuit Training and Low Carbohydrates Diet in the Young Obese Male in KSA
Official title: Effect of Circuit Training With Low-carbohydrate Diet on Body Composition, Cardiometabolic Indices, and Exercise Capacity in Young Males With Mild to Moderate Obesity in Saudi Arabia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Majmaah University
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Seventy young males with obesity participated in this study. They were divided randomly into two groups. Group 1 received circuit training with low-carbohydrate (LC) diet intervention and Group 2 was the control group. The study variables such as exercise capacity, body composition, skinfold thickness, percentage of body fat (BF%), and lipid profile were measured at the baseline and at the end of a 12-week intervention.
Primary purpose: TREATMENT

Brief summary: Obesity is one of the common public problems that its prevalence increase incredibly in the last three decades in KSA. Thirty obese males aged 20 to 39 years will participate in the study. The participants will be evaluated on skinfold thickness, percent of body fat, lipid profile, and exercise capacity. All participants will perform a circuit training of aerobic and resistance exercises and be instructed to follow a low carbohydrate diet for eight weeks.


Eligibility criteria: Inclusion Criteria:

1. Obese young male subjects with a mass index between BMI \>30 kg/m2 and 40 kg/m2).
2. Subjects ages range from 20 to 39 years.
3. Previously sedentary, defined as no strength training and less than 150 minutes of brisk walking or moderate exercise per week and \< less than 60 minutes of vigorous exercise per week in the preceding 6 months.
4. Only subjects who are nonsmokers.
5. Subjects who are not taking insulin.
6. Had no evidence or history of coronary artery disease.

Exclusion Criteria:

1. Subjects were excluded if they reported a history of heart disease, respiratory conditions, stroke, diabetes, recent cancer, other life-threatening illness, or any condition that limited their ability to engage in moderate-intensity exercise.
2. Smoking

Primary outcomes:
measure: Cardiometabolic index
timeFrame: 12 weeks
measure: Exercise capacity
timeFrame: 12 weeks
measure: Body Weight
timeFrame: 12 weeks
measure: Height
timeFrame: 12 weeks
measure: Body mass index
timeFrame: 12 weeks
measure: Waist circumference
timeFrame: 12 weeks
measure: Hip circumference
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Majmaah
country: Saudi Arabia
facility: Majmaah University
state: Riyadh
Study officials:
References:
Clinical trial NCT06635109: Investigating the Effect of Carpal Tunnel Syndrome on Activity and Participation
Official title: Investigation of the Effect of Different Severities of Carpal Tunnel Syndrome on Activity and Participation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals between the ages of 18-65 who were diagnosed with CTS in the dominant hand and who volunteered to participate in the study were included.

Brief summary: The aim of our study was to examine the effect of different severities of Carpal Tunnel Syndrome on activity and participation within the framework of the International Classification of Functioning, Disability and Health (ICF).

Detailed description: Individuals between the ages of 18-65 who were diagnosed with CTS in the dominant hand and who volunteered to participate in the study were included. SF-36, Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH), Michigan Hand Outcomes Questionnaire and Boston Carpal Tunnel Questionnaire - Functional Status Scale will be used to assess activity and participation. The questionnaires will be filled out via Google Forms. Shapiro-Wilk test will be performed to determine the distribution of the data. Whether the dependent variables differ between groups will be analysed by One-way ANOVA (continuous). For significant F-test, an additional investigation of differences between groups will be performed with Gabriel's post hoc procedure.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of CTS in the dominant hand
* Being between the ages of 18-65
* Volunteering to participate in the study

Exclusion Criteria:

* Having systemic inflammatory disease
* Having a disease that may cause polyneuropathy such as diabetes mellitus
* Having a pacemaker
* Having a disease affecting the central nervous system
* Having cervical radiculopathy
* History of previous operation or local steroid injection due to CTS

Primary outcomes:
measure: Short Form - 36 Quality of Life Questionnaire (SF-36)
timeFrame: 15 minutes
measure: Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH)
timeFrame: 10 minutes
measure: Michigan Hand Questionnaire (MHQ)
timeFrame: 15 minutes
measure: Boston Carpal Tunnel Questionnaire - Functional Status Scale
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Science University
Study officials:
References:
Clinical trial NCT02960009: Motor Excitability Study of High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Chronic Stroke
Official title: Motor Excitability Study of High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Chronic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: High definition tDCS will be conducted to both stroke and healthy subjects on primary motor cortex area to explore the motor excitability changes before and after stimulation. In next stage, a randomized control trial with 20-session training will be conducted to evaluate the effectiveness of transient modulation of cortical excitability through multisite HD-tDCS with EMG driven robot hand training, a sham stimulation with EMG-driven robot hand training will be applied as control group.


Eligibility criteria: Inclusion Criteria:

1. Sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment;
2. Have moderate to severe motor disability at the paretic upper limb (assessed by Fugl-Meter Assessment (FMA), and Action Research Arm Test (ARAT));
3. Hemiparesis resulting from a single unilateral lesion of the brain with onset at least 6 months before data collection

Exclusion Criteria:

1. Severe hand spasticity, open hand wound or hand deformity;
2. Visual field deficits;
3. Aphasia, neglect, and apraxia;
4. History of alcohol, drug abuse or epilepsy;
5. Bilateral infracts;
6. Uncontrolled medical problems;
7. Serious cognitive deficits \[Mini-Mental State Examination (MMSE) \< 21\];
8. Major depression
9. Metal implants inside body
10. MRI, TMS and tDCS contraindications

Primary outcomes:
measure: Electroencephalography (EEG) and Electromyography (EMG)
timeFrame: Before intervention, During intervention, After intervention, 6-month after intervention
measure: Action Research Arm Test (ARAT)
timeFrame: Before intervention, After intervention, 6-month after intervention
measure: Fugl-Meyer Assessment Upper Extremity (FMA-UE)
timeFrame: Before intervention, After intervention, 6-month after intervention
Secondary outcomes:
measure: Magnetic Resonance Imaging (MRI)
timeFrame: Before intervention, After intervention, 6-month after intervention
measure: Transcranial Magnetic Stimulation (TMS)
timeFrame: Before intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Biomedical Engineering, The Chinese University of Hong Kong
Study officials:
affiliation: Department of Biomedical Engineering, CUHK
name: Raymond Kai-yu Tong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01159509: The Effect of Hypertrophic Pyloric Stenosis (HPS) on Sodium Intake in Childhood
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Hypertrophic Pyloric Stenosis
Keywords: hypertrophic pyloric stenosis
sodium intake
Healthy children with no chronic diseases
Status post HPS
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: University of Haifa
First posted: 2010-07-09
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children ages 7-13 years. Status post HPS in infancy

Brief summary: The loss of sodium during infancy causes long term changes in sodium intake. Human research shows that the loss of maternal sodium during pregnancy and neonatal after birth causes an increase sodium intake during childhood. A study that examined sodium intake among infants that were treated with diuretics during the post-natal period found changes in sodium intake compared to controls. In this study we will test sodium intake in young children who have suffered from vomiting due to Hypertrophic Pyloric stenosis during early infancy.


Eligibility criteria: Inclusion Criteria:

* Children ages 7-13 years
* Status post HPS in infancy

Exclusion Criteria:

* Children with chronic diseases
* Hospitalization due to dehydration after HPS hospitalization

Primary outcomes:
measure: Increased sodium intake
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: