louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00208741: Study To Evaluate The Effects Of Gabitril™ In Patients With Social Anxiety Disorder
Official title: A 12-Week Open-Label Study Followed By A 24-Week Double-Blind Discontinuation Exploratory Study To Evaluate The Effects Of Gabitril™ (Tiagabine Hydrochloride) In Patients With Social Anxiety Disorder (SAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Social Anxiety Disorder
Keywords: Social Anxiety Disorder
Mental Health
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Cephalon
First posted: 2005-09-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to determine how safe and effective Gabitril is for outpatients with Social Anxiety Disorder (SAD).

Detailed description: This study is being conducted at two sites in the United States. Approximately 50 patients, who are between the ages of 18 and 65 years old will be enrolled at Emory. This study consists of two parts. The first part consists of 12 weeks of open-label treatment with Gabitril. If the study doctor determines that the patients condition has improved and they have completed the initial 12 weeks of treatment they may be eligible for the second part of the study. This part is a 24-week double-blind treatment period with either Gabitril or placebo (inactive medication). There will also be a follow-up visit about 1 to 3 weeks after they have completed taking the study medication. Altogether study participation is expected to last approximately 37 weeks.

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of SAD
* CGI (S) ≥ 4 at screen
* LSAS ≥ 50 at baseline
* Covi Anxiety Scale score greater than the Raskin depression Scale total score at screen

Exclusion Criteria:

* Non-responsive to adequate trials of two or more treatment medications, if previously treated for SAD.
* HAM-D ≥15 or a score of \>2 on Item 1 at baseline
* Serious or unstable medical condition
* Alcohol or substance use disorder within 6 months prior to study

Primary outcomes:
measure: Liebowitz Social Anxiety Scale (LSAS)
measure: Clinical Global Impression-Change (CGI-C)
Secondary outcomes:
measure: Hamilton Anxiety Scale (HAM-A)
measure: Social Phobia Inventory (SPIN)
measure: Pittsburgh Sleep Quality Index (PSQI)
measure: 36-Item Short-Form Health Survey (SF-36)
measure: Clinical Global Impression-S (CGI-S).
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Long Island
country: United States
facility: Hillside Hospital of the North Shore-Long Island Jewish Health System
state: New York
city: New York
country: United States
facility: Columbia/New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Emory University
name: Philip T Ninan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05027841: Proprioception on Balance and Gait in Hemiparetics
Official title: Investigation of The Effect of Proprioception on Balance and Gait Functions in Hemiparetic Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemiparesis
Proprioceptive Disorders
Gait, Hemiplegic
Lead sponsor: Istanbul Aydın University
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemiparetic individuals

Brief summary: The loss of sensorial feedback causes gait impairment in hemiparesis. The studies show that proprioceptive impairment of knee is related to falling in these patients. The aim of this study is to investigate the effects of proprioception on balance and gait functions in hemiparetic individuals.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 20-65 and discharged from the hospital,
* Diagnosed with hemiparesis at least 4 weeks ago,
* First time and unilateral hemiparesis,
* Modified Rankin Score ≤ 3,
* Hodkinson Mental Test ≥ 6,
* Individuals who agree to receive treatment will be included in the study.

Exclusion Criteria:

* Having vision and hearing problems,
* Having other accompanying neurological, psychiatric and/or orthopedic problems other than hemiparesis,
* Medically unstable,
* Diseases that will affect the lower extremity sense,
* Individuals with open wounds, circulation problems, and skin lesions in the area to be treated will be excluded from the study.

Primary outcomes:
measure: Sensorial Assessment-1
timeFrame: 2 minutes
measure: Sensorial Assessment-2
timeFrame: 2 minutes
measure: Sensorial Assessment-3
timeFrame: 2 minutes
measure: Balance assessment
timeFrame: 30 second
measure: Gait parameters
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Aydın University
Study officials:
References:
Clinical trial NCT04016441: Cost and Quality in Consumer Sunscreen Preferences
Official title: Cost and Quality in Consumer Sunscreen Preferences
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: sunscreen
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2019-07-11
Enrollment: 487
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study is a cross-sectional study of self-identified sunscreen users age 18 years and older.

Brief summary: This study seeks to determine what price consumers are willing to pay for a sunscreen product containing their ideal combination of attributes or qualities. This study will assess consumer preferences for various sunscreen qualities, as well as the relative contribution of each preference to the consumer's monetary valuation of a complete sunscreen product. The hypothesis is that respondents' willingness to pay for each sunscreen attribute will vary by demographic characteristics, especially self-identified race and socioeconomic class


Eligibility criteria: Inclusion Criteria:

* Subjects age 18 years old or older.
* Subjects who are capable of completing an online, English survey.

Exclusion Criteria:

* Subjects less than 18 years old
* Subjects who have previously completed the study.
* Subjects who are not able to complete an online, English survey.

Primary outcomes:
measure: Frequency of sunscreen preference differences between ideal and willingness to pay
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
Clinical trial NCT06556641: A Clinical Study of GZR33 and GZR101 in Healthy Subjects
Official title: Phase Ib Clinical Study on the Safety, Tolerance, Pharmacokinetics, and Pharmacodynamics of GZR33 and GZR101 in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Gan and Lee Pharmaceuticals, USA
Sponsor class: INDUSTRY
First posted: 2024-08-16
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of GZR33 and GZR101 in healthy adult male subjects.This study consists of Part A and Part B.

Part A is a randomized, open-label, single-dose, two-sequence, two-period, cross-over design comparative study evaluating the PD and PK characteristics of GZR33 and Insulin Degludec Injection.

Part B is a randomized, double-blind, placebo-controlled, multiple-dose, parallel-group design study evaluating the safety, tolerability, immunogenicity, and PK of GZR33 and GZR101.


Eligibility criteria: Inclusion Criteria:

* 1. Voluntarily participated in the study and signed the informed consent form (ICF);
* 2.Chinese healthy male adult subjects aged 18-45 years old (including 18 and 45 years old as of the date of signing the ICF);
* 3.During screening period, the body mass index (BMI) between 19.0 and 24.0 kg/m2, inclusive, and a body weight\>50 kg (not containing 50kg).

Exclusion Criteria:

* 1.History of drug abuse within one year prior to screening.
* 2.History of alcohol abuse within 6 months prior to screening (alcohol abuse is defined as more than 14 units weekly: 1 unit of alcohol equals to 360 mL of beer, 150 mL of wine, or 45 mL of 40% alcohol).The subject who smoke more than 5 cigarettes per day within 3 months prior to screening, smoke within 48 h prior to the use of the investigational drug, and is unwilling to refrain from smoking and drinking during the trial period.
* 3.Allergic constitution, or history of bronchial asthma, hives, eczema and other allergic diseases (except mild asymptomatic seasonal allergy), or known allergy to the investigational drug or its excipients, hypersensitivity or intolerance.
* 4.Hepatitis B surface antigen (HBsAg), hepatitis C antibodies, syphilis spiral test or human immunodeficiency virus (HIV) antibodies positive.
* 5.History of needle and blood sickness, and subject couldn't tolerate venipuncture for blood collection, or be difficult to collect blood.

Primary outcomes:
measure: AUC0-24h
timeFrame: From 0 to 24 hours
measure: Incidence of adverse events (AE)
timeFrame: From Predose to Day12
Secondary outcomes:
measure: Cmax
timeFrame: From Predose to Day7
measure: tmax
timeFrame: From Predose to Day7
measure: AUC0-last
timeFrame: From Predose to Day7
Other outcomes:
Locations:
city: Xingtai
country: China
facility: Study Site
state: Hebei
Study officials:
affiliation: Gan & Lee Pharmaceuticals.
name: Clinical Transparency
role: STUDY_DIRECTOR
References:
Clinical trial NCT00674141: Nasal Administration of Dexamethasone for Multiple Sclerosis (MS) Treatment
Official title: Nasal Administration of Dexamethasone for MS Treatment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: MS Patient With Relpasing Remitting Attacks
Keywords: Multiple Sclerosis, relapsing remitting, Dexamethasone
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2008-05-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study aims to assess the safety and efficacy of nasale administration of Dexamethasone in relapsing MS patients


Eligibility criteria: Inclusion Criteria:

* MS patients with esatblished relapsing remitting attacks
* increase in EDSS of at least 1 point for a least one day

Exclusion Criteria:

* children under 18
* pregnant patients
* patients with diabetes
* known allergy to steroids
* patients who received steroids within 3 months prior to the study

Primary outcomes:
measure: reduction in the EDSS functional system score
timeFrame: four months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hebrew University, Jerusalem. Israel
name: Elka Touitou, PhD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01466699: The Study of Blood Pressure Variability to Impact Arterial Stiffness and Carotid Atherosclerosis
Official title: The Relationship of Blood Pressure Variability, Arterial Stiffness and Carotid Atherosclerosis in Beijing Residents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carotid Atherosclerosis
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2011-11-08
Enrollment: 1235
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants in this study are community residents from Being in China

Brief summary: The purpose of this study is to investigate whether and what extent blood pressure variability is associated with arterial stiffness and carotid atherosclerosis, furthermore to compare the difference in the relationship of the types of blood pressure variability with arterial stiffness and carotid atherosclerosis.


Eligibility criteria: Inclusion Criteria:

* Can step by himself/herself

Exclusion Criteria:

* Cardiovascular and cerebrovascular diseases
* Secondary hypertension
* Chronic cardiac, renal, gastro-intestinal, pulmonary or any other systemic disease process requiring chronic intake of prescription medications

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02006199: Effect of Mindfulness Based Treatment for Obsessive-compulsive Disorder
Official title: Effect of Mindfulness Based Treatment for Obsessive-compulsive Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obsessive-compulsive Disorder
Keywords: obsessive-compulsive disorder
mindfulness
meditation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 0
Sex: ALL
Minimum age (years): 17
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Hypothesis of this study is that mindfulness meditation would decrease the severity of obsessive-compulsive symptoms.

Detailed description: Before and after 8 weeks of mindfulness program, We will measure Y-BOCS scores in OCD patients. As a control program, relaxation and psychoeducation will provided to OCD patients.

Eligibility criteria: Inclusion Criteria:

* obsessive-compulsive disorder
* age 17-55

Exclusion Criteria:

* currently undergoing Cognitive Behavioral Therapy, psychotherapy
* other medical disease

Primary outcomes:
measure: Yale-Brown Obsessive compulsive scores
timeFrame: 8 weeks
Secondary outcomes:
measure: Neurocognitive profile (emotion-memory task)
timeFrame: 8 weeks
Other outcomes:
measure: HAM-D
timeFrame: 8 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University College of Medicine
name: Jun Soo Kwon, MD phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06258499: Bone Healing Accelerant (BHA) Versus Autologous Bone Grafting (ABG) for Hindfoot or Ankle Arthrodesis
Official title: A Multicenter, Randomized, Controlled, Blinded Study of the Safety and Efficacy of Bone Healing Accelerant Versus Autologous Bone Grafting in Subjects Undergoing Hindfoot or Ankle Arthrodesis and Who Require Supplementary Grafting
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Foot Deformities
Lead sponsor: Carmell Therapeutics Corporation
Sponsor class: INDUSTRY
First posted: 2024-02-14
Enrollment: 0
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: This study is being conducted to demonstrate the safety and effectiveness of Bone Healing Accelerant (BHA) product when applied to the joint space of the ankle of hindfoot (the section of the foot immediately below the ankle joint) during fusion surgery. It is hypothesized that by 6 months, the number of subjects with successful bone fusion will be greater in the BHA-treated group compared to subjects treated with standard of care alone.


Eligibility criteria: Inclusion Criteria:

* Patient has pain with weight-bearing in the joint(s) below that, in the opinion of the Investigator, warrants arthrodesis:

  1. Tibiotalar (ankle)
  2. Talocalcaneal (subtalar)
  3. Talonavicular
  4. Calcaneocuboid
  5. Double hindfoot (e.g., talonavicular and talocalcaneal joints)
  6. Triple hindfoot (subtalar, talonavicular and calcaneocuboid joints
* Joint space(s) can, in the opinion of the Investigator, be adequately filled with no more than 9 cc of graft material (BHA or ABG)
* Each fused joint can be adequately compressed and rigidly stabilized with plates, screws, staples or a combination thereof. External fixation, percutaneous Kirschner wires or intramedullary rods may not be used.
* Patient is willing and able to comply with all study requirements including all postoperative clinical and radiographic evaluations.
* If patient is a woman of childbearing bearing potential (not post-menopausal for 12 months or surgically sterile), patient has a urine pregnancy test with a negative result at screening and on the day of surgery, prior to the procedure. These trial participants must commit to adequate birth control through the 52-week follow-up

Exclusion Criteria:

* Skeletally immature patients (i.e., radiographic evidence of open physes), regardless of age
* Bone deficit, defect or void requiring a structural graft
* Condition requiring intramedullary nailing or external fixation for the arthrodesis
* Condition requiring osteotomy or fusion of any midfoot joints.
* Prior arthroplasty, arthrodesis, major surgical repair or reconstruction of the index ankle or hindfoot joints.

Primary outcomes:
measure: Successful Radiographic Fusion
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04729699: Changes and Associations Between Cervical Range of Motion, Pain, TMJ Range of Motion and Quality of Life in Migraineurs Applying Physical Therapy
Official title: Changes and Associations Between Cervical Range of Motion, Pain, Temporomandibular Joint Range of Motion and Quality of Life in Migraineurs Applying Physical Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Temporomandibular Joint Disorders
Myofascial Trigger Point Pain
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 19
Sex: FEMALE
Minimum age (years): 37
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effects of physiotherapy program and review the associations between neck movements, pain, temporomandibular joint (TMJ) movements and quality of life in individuals with migraine.

Detailed description: Migraine is one of the most common type of headaches in the world causing the greatest disability in individuals under 50 years of age. Many different health organizations (American Headache Society etc.) recommend regular physical activity and exercise for the treatment and prevention of migraine. However, the relationship between aerobic exercise and migraine is still not completely clear. Unfortunately, a research database to validate the benefits of exercise for people with migraine is still being developed.

The aim of this study is to assess the effects of physiotherapy program and review the associations between neck movements, pain, temporomandibular movements and quality of life in individuals with migraine.

The study was approved by Committee on Biomedical Research Ethics of Kaunas Region (2020-06-30 No.BEC-SR(M)-266).

Eligibility criteria: Inclusion Criteria:

* Individuals diagnosed with migraine 2 or more years ago
* Headache, occurring at least 6 times a year
* Individuals from 18 years of age
* Voluntary patient consent to participate in the study

Exclusion Criteria:

* Neurological or psychiatric disorder
* Visiting an orthodontist, taking muscle relaxants
* Head or neck injury, cervical spine hernia, facial or temporomandibular injury

Primary outcomes:
measure: Goniometry for cervical range of motion
timeFrame: Baseline to 6 weeks
measure: Algometry for pressure pain thresholds (PPT)
timeFrame: Baseline to 6 weeks
Secondary outcomes:
measure: Anthropometry for TMJ
timeFrame: Baseline and after 6 weeks
measure: Functional health and well-being - SF-36v2®
timeFrame: Baseline and after 6 weeks
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences, Department of Rehabilitation
Study officials:
References:
Clinical trial NCT00797342: A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04629991 in Healthy Volunteers
Official title: A Phase 1, Randomized, Double Blind (Sponsor Open), Placebo Controlled, Single-Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effect of PF-04629991 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: rheumatoid arthritis First in human safety pharmacokinetics pharmacodynamics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-25
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04629991 in healthy subjects. Dose exploration will proceed in a step-wise manner, beginning with low doses not expected to have significant biological effects and proceeding to doses approximating or exceeding the anticipated therapeutic level. Doses to be explored may be limited by tolerability, and will not exceed levels previously shown to be tolerable in animals.


Eligibility criteria: Inclusion Criteria:

* Healthy non-smoking men and women
* body mass index 18-30 kg/m2

Exclusion Criteria:

* Women must not be able to have children
* no current infections

Primary outcomes:
measure: Pharmacokinetics e.g., maximum concentration and area under the concentration-time curve
timeFrame: 2 weeks
measure: Safety/Tolerability e.g., reported adverse events and safety laboratory studies
timeFrame: 2 weeks
measure: Pharmacodynamics e.g., changes in a peripheral blood biomarker
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: