louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03099473: Effects of Ocular Electroacupuncture on Trochlear Nerve Palsy
Official title: A Randomized Trial of Ocular Electroacupuncture for Trochlear Nerve Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trochlear Nerve Palsy
Keywords: electroacupuncture
trochlear nerve palsy
eyeball movement
diplopia
ocular motility disorder
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 144
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: TREATMENT

Brief summary: The purpose of the study is to testify the efficacy of treating trochlear nerve palsy with ocular electroacupuncture or ocular acupuncture, and to compare the efficacy between these two interventions.

Detailed description: The purpose of the study is to testify whether ocular electroacupuncture or ocular acupuncture is effective for trochlear nerve palsy (TNP), through treating TNP patient for 6 weeks, using self-invented acupoints according to anatomy of extraocular muscles innervated by trochlear nerve, and using sham acupuncture as controlled group, and try to provide clinical evidence for promoting these new techniques.

Eligibility criteria: Inclusion criteria;

1. patient with confirmed diagnosis of trochlear nerve palsy made by neurologist or ophthalmologist;
2. patient in stable condition after treatment for primary disease;
3. age between 18 to 80 years old without gender limitation;
4. haven't received acupuncture intervention for TNP before;
5. patient with conscious, willing to cooperate and voluntarily agreed to participate and signed informed consent forms.

Exclusion criteria:

1. those with other diagnosed medical conditions known to contribute to TNP symptoms, such as thyroid disease, myasthenia gravis, mitochondrial myopathy, congenital strabismus or received strabismus surgery;
2. those with color blindness, dyschromatopsia or abnormal retinal correspondence couldn't complete computerized diplopia test;
3. those with serious medical conditions that might limit their participation;
4. those with eye or other location with serious infections;
5. women who had a positive pregnancy test or who were planning to become pregnant during the study period;
6. those with bleeding tendency, blood coagulation dysfunction or taken anticoagulant drugs;
7. who had participate in other clinical trials, which may affect the results.

Primary outcomes:
measure: Change from Baseline in Angle of diplopia deviation at 6 Weeks
timeFrame: 6 week
Secondary outcomes:
measure: The quality of life questionnaire for ocular motor nerve palsy
timeFrame: 6 week
Other outcomes:
Locations:
city: Harbin
country: China
facility: The first affiliated hospital of Harbin Medical University
state: Heilongjiang
Study officials:
affiliation: First Affiliated Hospital of Harbin Medical University
name: Lingyun Zhou, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03602573: Liver Fibrosis in Peri-menopausal Women
Official title: Nonalcoholic Fatty Liver Disease and Associated Liver Fibrosis in Peri-menopausal Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nonalcoholic Steatohepatitis
Liver Fibroses
Menopause
Keywords: Nonalcoholic steatohepatitis
Liver fibrosis
Menopause
Hormone
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 200
Sex: FEMALE
Minimum age (years): 46
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Females, age of 46-55 years, premenopause and postmenopause

Brief summary: This is a prospective observational study in a single medical center.

The aim is to evaluate the status of fibrosis and steatosis of liver parenchyma in peri-menopausal women using noninvasive methods of vibration-controlled transient elastography (VCTE) with controlled attenuation parameter (CAP) and serum biomarkers.

Recruitment period: 2018/08/01 to 2019/07/31

Patient number: 200 females

Inclusion criteria:

1. Females, age of 46-55 years
2. Willing and able to comply with the study requirements
3. Willing and able to provide written informed consent to participate in the study

Exclusion criteria:

1. Unable to complete the noninvasive procedure of VCET and CAP
2. Unwilling to provide written informed consent to participate in the study

Laboratory tests and examinations:

Baseline and two follow-up visits (every 6 months):

1. Blood pressure
2. BW, BH, waist circumference, BMI
3. Complete blood cell (CBC) count
4. Albumin, AST, ALT, alkaline phosphatase, total bilirubin, r-GT, uric acid, hsCRP
5. Sugar (fasting), HbA1c, insulin, HOMA-IR
6. DM lipid profiles, adiponectin, leptin
7. Liver ultrasound, FibroScan touch 520
8. FSH, Estrodiol (E2), LH
9. TSH, free T4
10. HBsAg, anti-HCV, HBV DNA, HCV RNA, HBsAg quantification, HBV genotype (if HBsAg or anti-HCV positive)
11. ANA, Anti-mitochondrial antibody
12. Review history of drug and menstruation cycles


Eligibility criteria: Inclusion Criteria:

1. Females, age of 46-55 years
2. Willing and able to comply with the study requirements
3. Willing and able to provide written informed consent to participate in the study

Exclusion Criteria:

1. Unable to complete the noninvasive procedure of VCET and CAP
2. Unwilling to provide written informed consent to participate in the study

Primary outcomes:
measure: The impact of estrogen level on liver steatosis by FibroScan touch 520
timeFrame: 1 year
measure: The impact of estrogen level on liver fibrosis by FibroScan touch 520
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yi-Cheng Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06575673: An Internet-based Dialectical Behaviour Therapy-informed Skills Training for Reducing Alcohol Consumption and Improving Psychological Distress of Adult Smokers.
Official title: Effect of an Internet-based Dialectical Behaviour Therapy-informed Skills Training for Promoting Smoking Cessation and Improving Psychological Distress of Smokers: A Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Smoking
Keywords: Dialectical behaviour therapy
Skills training
Internet-based intervention
Psychological distress
Adult smokers
Smoking
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 1. To determine the feasibility, acceptability, and preliminary effects of an internet-based DBT-ST for promoting smoking abstinence/reduction and improving psychological distress/emotional regulation in adult smokers
2. To explore the participants' experiences and perceptions (e.g., perceived benefits/weaknesses) towards the proposed intervention


Eligibility criteria: Inclusion Criteria:

* Hong Kong Chinese aged 18-64 years
* Had smoked at least one cigarette per day over the previous three months
* Indicate psychological distress as measured by the Depression, Anxiety, and Stress Scale-21
* Have an intention to stop smoking
* Have an electronic device and are willing to receive interventions via the internet

Exclusion Criteria:

* Experiencing psychotic disorders/cognitive impairment/communication problems
* Participating in other smoking cessation programs or related psychosocial interventions

Primary outcomes:
measure: Biochemically validated 7-day PPA (an exhaled CO test and a salivary cotinine test)
timeFrame: Baseline, 3-month post-intervention
measure: Level of psychological distress
timeFrame: Baseline, 3-month post-intervention
Secondary outcomes:
measure: Self-reported 7-day PPA
timeFrame: Baseline, 3-month post-intervention
measure: Self-reported smoking reduction of at least 50%
timeFrame: 3-month post-intervention
measure: Quit attempts
timeFrame: Baseline, 3-month post-intervention
measure: Emotion dysregulation
timeFrame: Baseline, 3-month post-intervention
measure: Distress tolerance
timeFrame: Baseline, 3-month post-intervention
Other outcomes:
measure: Acceptability
timeFrame: 3-month post-intervention
measure: Feasibility of the intervention
timeFrame: 3-month post-intervention
measure: Feasibility of the intervention
timeFrame: 3-month post-intervention
measure: Feasibility of the intervention
timeFrame: 3-month post-intervention
measure: Semi-structured interview
timeFrame: 3-month post-intervention
Locations:
city: Hong Kong
country: Hong Kong
facility: Hospital Authority
Study officials:
References:
Clinical trial NCT01235273: Treatment of the lOw IGF-1 Syndrome aSsociated With Chronic Heart fAilure: A Randomized, Placebo-Controlled, Double-Blind Study.
Official title: Phase 2 Study of Growth Hormone Administration in Patients With Chronic Heart Failure and Low IGF-1 Levels
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Chronic Heart Failure
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2010-11-05
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to determine whether treatment of the low IGF-1 syndrome in patients with CHF is able to modify some functional parameters, recognized as valid surrogate end-points of CHF progression.


Eligibility criteria: Inclusion Criteria:

* patients of either sex affected by CHF NYHA class II-III, secondary to ischemic or idiopathic dilated cardiomyopathy
* age range 30-80 years
* stable medications for at least two months prior to randomization, including ACE inhibitors or AT1 antagonists and beta-blockers (unless untolerated).
* LV ejection fraction 40% or less
* Peak VO2 consumption during a CPET ≤ 16 ml/kg/min.
* LV end-diastolic dimension 55 mm or more
* low IGF-1 levels and a satisfactory response to an IGF-1 generation test
* informed consent

Exclusion Criteria:

* haemodynamic clinically significant primary valvular disease or significant congenital heart disease
* acute pericarditis/myocarditis
* inability to perform a bicycle exercise test
* Poorly controlled diabetes mellitus (HbA1c \>8.5)
* active proliferative or severe non-proliferative diabetic retinopathy
* active and/or history of malignancy
* evidence of progression or recurrence of an underlying intracranial tumor
* unstable angina or recent myocardial infarction (less than 5 months)
* severe liver disease
* serum creatinine levels \>2.5 mg/dl
* Inability to cooperate or administer the study drug
* Patients participating in any other clinical study, within 30 days prior to screening visit and/or during this particular study period

Primary outcomes:
measure: increase of peak VO2 consumption by at least 2.5 ml/kg/min during maximal physical exercise test.
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Antonio Cittadini
Study officials:
References:
Clinical trial NCT00283673: Effect of Exercise Intervention on Various Physiologic Factors That Change With Increasing Age
Official title: Impact of Aerobic Exercise Training on Age Related Changes in Insulin Sensitivity and Muscle Oxidative Capacity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2006-01-30
Enrollment: 102
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study randomized healthy sedentary people age 20-80 years to 16 weeks of supervised exercise versus no exercise. Several end points were evaluated after 16 weeks including insulin sensitivity and muscle physiology.

Detailed description: Healthy subjects performing \< 30 min exercise twice per week were studied prior to randomization and after of sixteen weeks exercise. They were randomized to sixteen weeks of supervised exercise performed on a stationary bike vs. placebo exercise (a series of flexibility exercises performed at home). Intensity, duration and frequency of exercise were gradually increased to four sessions per week lasting forty minutes each and achieving 80% target heart rate. Participants were weighed perioidically and counseled appropriately when weight changed by \> 2 %. Insulin sensitivity and muscle mitochondrial protein synthesis were studied.

Eligibility criteria: Healthy subjects performing \< 30 min exercise twice per week. Age 20-90 years. Willing to be randomized to exercise versus no exercise. Willing to be studied in General Clinical Research Center with studies including Muscle Biopsy.

Primary outcomes:
measure: Insulin sensitivity
Secondary outcomes:
measure: Muscle Mitochondrial Protein Synthesis
measure: mRNA of mitochondrial genes
measure: mRNA of genes involved in mitochondrial biogenesis
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: K. Sreekumaran Nair, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Short KR, Vittone JL, Bigelow ML, Proctor DN, Rizza RA, Coenen-Schimke JM, Nair KS. Impact of aerobic exercise training on age-related changes in insulin sensitivity and muscle oxidative capacity. Diabetes. 2003 Aug;52(8):1888-96. doi: 10.2337/diabetes.52.8.1888.
Clinical trial NCT05352373: The Role of Dietary Calcium for the Treatment of Osteopenia in Girls With Rett Syndrome
Official title: The Role of Dietary Calcium for the Treatment of Osteopenia in Girls With Rett Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rett Syndrome
Keywords: Low bone mass
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 32
Sex: FEMALE
Minimum age (years): 5
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double blind
Primary purpose: TREATMENT

Brief summary: Randomized, placebo-controlled trial of oral calcium supplementation for osteopenia in girls and women with Rett syndrome

Detailed description: Objective: The investigators conducted a randomized, double-blind, placebo-controlled trial to determine the safety and efficacy of oral calcium supplementation for the treatment of bone mineral deficits in individuals with Rett syndrome (RTT).

Methods: The investigators measured total body bone mineral content (BMC) and bone mineral density (BMD) by dual-energy x-ray absorptiometry and biomarkers of bone turnover by clinical laboratory techniques before and one year after oral calcium or placebo supplementation in 32 pre- and post-pubertal girls and young women with RTT. The calcium supplement was calculated to provide a twofold increase in the recommended dietary allowance of calcium for age.

Eligibility criteria: Inclusion Criteria

* clinical diagnosis of Rett syndrome

Exclusion Criteria

* parathyroid disease
* renal disease

Primary outcomes:
measure: Bone mineral content (BMC)
timeFrame: change from baseline to 1 year thereafter
measure: Bone mineral density (BMD)
timeFrame: change from baseline to 1 year thereafter
Secondary outcomes:
measure: Osteocalcin
timeFrame: change from baseline to 1 year thereafter
measure: Bone alkaline phosphatase
timeFrame: change from baseline to 1 year thereafter
measure: C-telopeptide
timeFrame: change from baseline to 1 year thereafter
measure: Calcium/creatinine ratio
timeFrame: change from baseline to 1 year thereafter
Other outcomes:
Locations:
Study officials:
affiliation: Baylor College of Medicine
name: Kathleen J Motil, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06578273: NeuroGlove PD Study Clinical
Official title: Peripheral Sensory Stimulation of the Hand and Synchronized Deep Breathing in the Treatment of Parkinson's Disease: Assessing Safety and Feasibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Parkinson Disease
Lead sponsor: NeuroGlove LLC
Sponsor class: INDUSTRY
First posted: 2024-08-29
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, homebased, interventional clinical study in which 8 subjects will be enrolled. Eight (8) subjects who suffer from Parkinson's disease will receive treatment using the NeuroGlove.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Safety and Feasibility of Peripheral Sensory Stimulation of the Hand in the Treatment of Parkinson's Disease

Detailed description: This is a prospective, homebased, interventional clinical study in which 8 subjects will be enrolled. Eight (8) subjects who suffer from Parkinson's disease will receive treatment using the NeuroGlove.

Up to 8 subjects enrolled and complete study procedures. There will be a single cohort in the study consisting of the subjects with PD who will receive treatment with NeuroGlove.

Eligibility criteria: Inclusion Criteria:

1. Able to and willing to provide informed consent. Legally authorized representatives (LARs) will not be allowed to consent on behalf of the subject.
2. Men and women ≥18 and \<85 years of age.
3. Carry an active diagnosis of PD
4. Suffer from PD symptoms that impact subject's daily activities and quality of life

   Exclusion Criteria:
5. Physical limitations of the upper extremity (e.g., fracture, joint deformity, severe spasticity/contracture, wounds, skin breakdown, lymphedema, etc.)
6. Lacks the ability to comprehend or follow instructions, or for any reason, in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements.
7. Currently participating in another interventional clinical trial (observational clinical trial participation is allowed for study enrollment.)

Primary outcomes:
measure: Use the UPDRS to Evaluate safety and feasibility of device
timeFrame: 4 weeks
measure: Use Custom Satisfaction Scale to Rate and severity of adverse events related to the use of the NeuroGlove.
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: NeuroGlove
state: Minnesota
Study officials:
References:
Clinical trial NCT05054673: Clinical Performance of Self-cured Universal Adhesive for Restoring Cervical Lesions in Geriatric Patients
Official title: Clinical Performance of Newly Introduced Self-cured Universal Adhesive for Restoring Cervical Lesions in Geriatric Patients Over One Year (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Universal Adhesive
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-09-23
Enrollment: 28
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel assignment
Primary purpose: TREATMENT

Brief summary: the study is conducted to evaluate the clinical performance of PALFIQUE universal adhesive (Tokuyama self-cure universal adhesive), Versus 3m ESPE™ single bond Universal Adhesive, for restoring cervical lesions in geriatric patients over one year.


Eligibility criteria: Inclusion Criteria:

* The patient had to be in good general health
* Geriatric patients
* Have an acceptable oral hygiene level
* Class V cavities in anterior and posterior teeth
* Males \& females included
* Anticipated availability for recalls (6 months and 12 months) through the 1-year study period

Exclusion Criteria:

* Lack of written informed consent to participate
* Poor oral hygiene,
* Severe bruxism
* Severe or chronic periodontitis
* Allergies to components of the materials used
* Underage patients
* Non vital pulp

Primary outcomes:
measure: Measuring the Marginal adaptation
timeFrame: 1 year
Secondary outcomes:
measure: level of Retention
timeFrame: 1 year
measure: Level of Marginal discoloration
timeFrame: 1 year
measure: Rate of Secondary caries
timeFrame: 1 year
measure: level of Postoperative sensitivity
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01976273: A Pilot Study Testing 1064nm Q-switch Laser Versus Glycolic Acid Peels for the Treatment of Melasma
Official title: A Pilot Study Comparing the Efficacy of 1064 Q-switch Laser vs. Glycolic Acid Peels for the Treatment of Melasma: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanosis
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2013-11-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out the safety and effectiveness of 1064 Q-Switch Laser Therapy compared to Glycolic Acid Chemical Peels for the treatment of melasma.

Detailed description: Participants in this study will be patients at the dermatology clinic who are clinically diagnosed with at least a 2X2 cm patch of melasma on each side of their face (forehead or cheek). Starting at 2 weeks before treatment (week 2), both sides will be pretreated and primed with 4% hydroquinone with, if necessary, 2.5% hydrocortisone cream BID. On the treatment day (2-weeks) and 6-weeks one half of the subject's face will receive glycolic acid peels and the other half of the face will receive 1064nm Q-switch laser. This study is a pilot study designed to determine feasibility of these procedures.

Eligibility criteria: Inclusion Criteria:

1. Subjects aged 18 years or older
2. Subjects with at least a 2 x 2 cm patch of melasma on each side of the face (forehead or cheek)
3. Subjects in general good health
4. Subjects must be willing and able to understand and provide informed consent for the use of their tissue and communicate with the investigator
5. Subjects must be willing to not apply other treatment options for melasma during the course of the study

Exclusion Criteria:

1. Subjects under 18 years of age
2. Subjects who are pregnant and/or lactating
3. Subjects who are unable to understand the protocol or to give informed consent
4. Subjects diagnosed with mental illness
5. Subjects who have concurrent active uncontrolled disease to facial area (i.e uncontrolled acne)
6. Subjects who have had a chemical peel in the past 3 months
7. Subjects who have used a prescribed retinoid in the past 3 months
8. Subjects with a bleeding disorder
9. Subjects with a history of abnormal wound healing
10. Subjects with a history of abnormal scarring
11. Subjects who report being allergic to glycolic acid

Primary outcomes:
measure: Visual Analog Scale (VAS) of Improvement Rated by a Blinded Dermatologist From at Week 10
timeFrame: Week 10
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References: