louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01057979: Motivational Interventions for Lifestyle and Exercise in College Students
Official title: Motivational Interventions for Exercise in Hazardous Drinking College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
Keywords: exercise
college students
Sedentary college students
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2010-01-28
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Engagement in substance-free activities, such as exercise, has an inverse relationship to substance use in college students. While exercise has numerous physical and mental health benefits, the majority of college students are sedentary, infrequently engaging in exercise. Although exercise interventions to date often suffer from significant attrition and poor adherence, motivational interventions for exercise are beginning to show promise. In this pilot study we propose to develop and evaluate a novel exercise intervention combining Motivational Enhancement Therapy (MET) with contingency management (CM) in sedentary college students who use alcohol.


Eligibility criteria: Inclusion Criteria:

* Sedentary college students who drink alcohol.

Exclusion Criteria:

* Medical contraindications for exercise.

Primary outcomes:
measure: Exercise engagement
timeFrame: 2 month, 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut Storrs
state: Connecticut
Study officials:
affiliation: St. Louis University
name: Jeremiah Weinstock, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weinstock J, Petry NM, Pescatello LS, Henderson CE. Sedentary college student drinkers can start exercising and reduce drinking after intervention. Psychol Addict Behav. 2016 Dec;30(8):791-801. doi: 10.1037/adb0000207. Epub 2016 Sep 26.
Clinical trial NCT04066179: Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients.
Official title: Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients -A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcoholic Hepatitis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 126
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: TREATMENT

Brief summary: The patients of Severe Alcoholic Hepatitis (SAH) will be included in study based on inclusion and exclusion criteria. The patients will be then randomized in 3 groups for therapy. They will receive either steroid or Granulocyte-Colony Stimulating Factor (GCSF) or both. They will be followed for atleast 90 days for improvements in symptoms and various predefined parameters. Primary outcome will be improvement in survival at 90 Days. Patients will be monitored at every follow up for disease progression and complications of therapy. The study results will be analyzed for differences in survival rate and complications in different groups to propose new therapeutic guideline in SAH patients.


Eligibility criteria: Inclusion Criteria:

* Severe alcoholic hepatitis patients \[Maddrey's score \> 32\] aged between 18 to 65 years.

Exclusion Criteria:

* Presence of active infections
* Acute Gastrointestinal bleed
* Hepatorenal syndrome
* Patient unwilling
* Discriminant Function \>90
* Autoimmune hepatitis
* Hepatitis B, Hepatitis C, Human immunodeficiency Virus cases
* Pregnancy
* Hemophagocytic lymphohistiocytosis (HLH)
* Hb\<8 and baseline White Blood Cell\>25000

Primary outcomes:
measure: increase in Survival at 90 days in all the groups.
timeFrame: 90 days
Secondary outcomes:
measure: Improvement in CTP (Child-Pugh Score) in all the groups.
timeFrame: Day 28
measure: Improvement in CTP (Child-Pugh Score) in all the groups.
timeFrame: Day 180
measure: Improvement in MELD (Model for End Stage Liver Disease) in all the groups.
timeFrame: Day 28
measure: Improvement in MELD (Model for End Stage Liver Disease) in all the groups.
timeFrame: Day 180
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT05392179: A Study in Subjects With Retinitis Pigmentosa
Official title: An Open-label, Phase II Study of ADX-2191 in Subjects With Retinitis Pigmentosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Retinitis Pigmentosa
Keywords: ADX-2191
Methotrexate
Retinitis Pigmentosa
Rhodopsin Mutation P23H
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-26
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An open-label Phase II clinical trial, 8 (eight) subjects with retinitis pigmentosa due to rhodopsin mutations (including P23H) will be identified and treated with serial intravitreal injections of ADX-2191 in the worse seeing eye. Ocular structure and function will be evaluated.


Eligibility criteria: Inclusion Criteria:

1. Up to 8 adult patients age 18 or older
2. Diagnosis of retinitis pigmentosa due to rhodopsin gene mutation, including P23H
3. Impairment on Visual Field as determined by perimetry

Exclusion Criteria:

1. Age \< 18 years
2. Pregnant
3. Previous inflammatory/infectious events involving the eyes

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in visual acuity
timeFrame: 16 weeks
measure: Central retinal sensitivity
timeFrame: 16 weeks
measure: Change in dark-adapted retinal sensitivity
timeFrame: 16 weeks
measure: Assessment for change in central subfield foveal thickness and ellipsoid zone area/width
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
Study officials:
References:
Clinical trial NCT03568279: Jaw-thrust on Postoperative Sore Throat
Official title: Influence of Two-handed Jaw Thrust on Postoperative Sore Throat
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: General Anesthesia
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 96
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of two-handed jaw thrust maneuver in patients undergoing endotracheal intubation for general anesthesia.


Eligibility criteria: Inclusion Criteria:

* ASA I-III
* Patients scheduled for general anesthesia with endotracheal intubation

Exclusion Criteria:

* Difficult airway
* Mallampatti scores greater than 2
* Recent sore throat
* Cervical spine disease
* Recent upper respiratory infection
* Recent analgesics
* History of head and neck surgery
* Friable teeth
* Multiple intubation attempts

Primary outcomes:
measure: Number of participants with postoperative sore throat for postoperative 24 hour
timeFrame: At postoperative 24 hour
Secondary outcomes:
measure: Number of participants with postoperative sore throat
timeFrame: At postoperative 2, 4, and 24 hour
measure: Postoperative sore throat scores
timeFrame: At postoperative 2, 4, and 24 hour
measure: Number of participants with postoperative hoarseness
timeFrame: At postoperative 2, 4, and 24 hour
measure: Number of participants with postoperative shivering
timeFrame: At postoperative 2, 4, and 24 hour
measure: Wound pain scores
timeFrame: At postoperative 2, 4, and 24 hour
measure: Number of participants with jaw discomfort
timeFrame: At postoperative 2, 4, and 24 hour
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Hyun-Chang Kim
state: Non-US/Canada
Study officials:
References:
citation: Huh H, Go DY, Cho JE, Park J, Lee J, Kim HC. Influence of two-handed jaw thrust during tracheal intubation on postoperative sore throat: a prospective randomised study. J Int Med Res. 2021 Feb;49(2):300060520961237. doi: 10.1177/0300060520961237.
Clinical trial NCT00608179: Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia
Official title: Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: epinephrine
glucose clamp
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2008-02-06
Enrollment: 32
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: This study will look at two FDA approved medications that improve how the pancreas works in patients with Type 2 Diabetes. In order to understand how these medications work in patients with diabetes we must first measure the normal response in healthy volunteers without diabetes. We will be looking at the body's normal physiological response to low blood sugar and whether this will be modified by these medicationsThe hypothesis would be that glimepiride induced insulin secretion will be inhibited by hypoglycemia.

Detailed description: In patients with type 2 diabetes, sulfonylurea drugs are a mainstay for effective glucose control. These agents produce their hypoglycemic effects via stimulation of endogenous insulin secretion. Oversecretion of insulin, per se, or a continued relative increase of the hormone even when plasma glucose is normal will result in hypoglycemia. This latter situation commonly occurs if a patient decides to omit, delay, or reduce the size of a meal. An important defense against hypoglycemia in the above situations is glucose dependent regulation of insulin secretion. In other words, a low ambient glucose concentration could regulate the magnitude of the amount of insulin released in response to a sulfonylurea. Thus during hypoglycemic conditions, the sulfonylurea would result in little or no insulin secretion, whereas its effects during hyperglycemia would be amplified. Glimepiride and glyburide are both second-generation sulfonlyurea drugs used commonly for treatment of type 2 diabetes. This study will compare the two and ask the following question:

Is Glimepiride insulin secretion dependent upon glucose concentration in-vivo?

Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects aged 30-60
* Body Mass Index 21-30 kg/m2
* All potential volunteers will have routine blood test to screen for hepatic, renal, and hematological abnormalities
* EKG treadmill stress test for volunteers over 40 years of age.
* Female volunteers of childbearing potential will undergo HCG pregnancy test.

Exclusion Criteria:

* Prior or current history of poor health
* Abnormal results following screening tests
* Pregnancy
* History of allergy to sulfonylurea or related drugs

Primary outcomes:
measure: catecholamines
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University
name: Stephen N. Davis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02511379: Clinical Evaluation of Systane® Balance in Dry Eye Subjects
Official title: Clinical Evaluation of Systane® Balance on Corneal Staining in Indian Subjects With Dry Eye
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2015-07-30
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Systane® Balance following 90 days of QID (4 times/day) dosing among Indian subjects with dry eye.

Detailed description: This study was conducted in India.

Eligibility criteria: Inclusion Criteria:

* Sign informed consent and willing and able to attend all study visits;
* Dry eye in both eyes diagnosed by an ophthalmologist;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential who are pregnant or breastfeeding;
* Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study;
* Ocular surgery or ocular trauma requiring medical or pharmacological treatment within 1 year of Screening;
* Use of topical ocular prescription or non-prescription medications, RESTASIS or topical ocular steroids within 14 days of Screening;
* Use of any artificial tears/gels/lubricants/rewetting drops within 4 hours of Screening;
* Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in Corneal Staining Total Score
timeFrame: Baseline (Day 0), Day 45, Day 90
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Alcon Research, Ltd
role: STUDY_DIRECTOR
References:
Clinical trial NCT02121379: Randomized Clinical Trial of 8 Weeks Pulmonary Rehabilitation in Advanced Stage Lung Cancer Patients With COPD During Cytotoxic Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Lung Cancer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-04-23
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pulmonary rehabilitation might be benificial in advanced lung cancer patients with COPD who undergo cytotoxic chemotherapy.

We will compare two groups, 8 week pulmonary rehabilitation group and usual care group.


Eligibility criteria: Inclusion Criteria:

* pathologically proven lung cancer
* chronic obstructive pulmonary disease
* age \> 20
* ECOG 0-1
* cytotoxic chemotherapy

Exclusion Criteria:

* other history of cancer within 5 years
* other major disease associated with heart, lung, neurology, mental and metabolic disorders
* osteolytic bone metastatis to weight bearing site
* uncontrolled infection

Primary outcomes:
measure: difference of VO2 max
timeFrame: 8 weeks
Secondary outcomes:
measure: difference of Saint George's Respiratory Questionannaire (SGRQ) score
timeFrame: 8 weeks
measure: difference of pulmonary function test
timeFrame: 8 weeks
measure: difference of 6 min walk test
timeFrame: 8 weeks
measure: difference of depression test
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT05479279: Effectiveness of Neck Stabilization Training Program With Conventional Therapy in Management of Text Neck Syndrome
Official title: Effectiveness of Neck Stabilization Training Program in Management of Text Neck Syndrome Among Smart Gadget Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Syndrome
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. To compare the effectiveness of neck stabilization training program with conventional physical therapy in management of neck pain and disability in individuals with text neck syndrome.
2. To compare the effectiveness of neck stabilization training program with conventional physical therapy in improving muscle strength and range of motion of cervical spine in individuals with text neck syndrome.

Detailed description: The text neck syndrome was described as a compilation of signs and symptoms due to the repetitive load, stress and pain in the body regions including; neck, shoulder joints, shoulder muscles, and thoracic region initiated by the excessive usage of smartphones for the prolonged time. The text neck syndrome is also called as 'Turtle neck neck syndrome' or 'anterior head syndrome.

Neck flexion in forward direction for using any smart phone could directly affects the cervical and upper thoracic spine. It is stated that increased tilt of the head forward to fifteen degrees exaggerate about 13 Kgs of mechanical force on the cervical spine.

Likewise it progresses to 18 Kgs at 30 degrees, 23 Kgs at 45 degrees and 28 Kgs at 60 degrees of forward neck flexion. The pathological consequences caused by incase of not managing the text neck could be alike to occupational overuse disease or repetitive stress and strain pathology.

Eligibility criteria: Inclusion Criteria:

* Gender (both men and women)
* Age: 18-30 years
* Participants using smart phones, laptops and tablets with screen time \>3 hours daily, for \>6 months.
* Patient diagnosed with text neck syndrome
* Trigger points in cervical muscles (trapezius, levator scapulae and scalene muscles)

Exclusion Criteria:

* Patient diagnosed with neck pain other than text neck syndrome

Primary outcomes:
measure: Neck disability index
timeFrame: 6th week
measure: NPRS
timeFrame: 6th week
measure: Range of motion
timeFrame: 6th Week
measure: Cranio-vertebral angle
timeFrame: 6th Week
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Railway General Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: maria Khalid, MSOMPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00038779: Blood Transplantation for Patients With Hematologic Malignancies or Bone Marrow Failure States
Official title: Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation for Patients With Hematologic Malignancies or Bone Marrow Failure States
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Leukemia
Non Hodgkin's Lymphoma
Aplastic Anemia
Keywords: Lymphoma
CML
CLL
AML
ALL
MDS
AA
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2002-06-07
Enrollment: 7
Sex: ALL
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess early treatment failure within 100 days and to assess the effect of this regimen on engraftment, GVHD, immune recovery, relapse of malignancy and survival.


Eligibility criteria: * Patients with acute leukemia, lymphoma that failed to respond or relapsed after chemotherapy or CML beyond first chronic phase.
* Patients with aplastic anemia or myelodysplasia which failed to respond to primary therapy are eligible.
* Patients with low grade lymphoma or CLL will only be eligible if they failed two chemotherapy regimens and have stage IV disease.
* Patients must be \<age 50 with a related haploidentical donor (phenotypically one, two or three HLA A, B and DR antigen mismatched) donor.
* Patients should have adequate hepatic and renal function with a bilirubin of less than or equal to 1.5mg%, SGPT less than or equal to 3x the upper limits of normal, and creatine less than or equal to 1.5mg%.
* Patients with serious intercurrent medical illness are not eligible.
* Patients and their donors must provide written informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
References:
Clinical trial NCT00524979: Digital Voice Analysis in Patients With Schizophrenia
Official title: Digital Voice Analysis in Patients With Schizophrenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Lead sponsor: BeerYaakov Mental Health Center
Sponsor class: OTHER_GOV
First posted: 2007-09-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Schizophrenic patients
* Other mental disease patients
* Healthy people

Brief summary: There is a differences in voice frequency of schizophrenic patients compared to patients with other mental diseases and compared to mentally healthy people.


Eligibility criteria: Inclusion Criteria:

* Schizophrenic patients
* Other mental disease patients
* Healthy people
* People above age 18

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Yaakov
country: Israel
facility: Beer Yaakov MHC
Study officials:
affiliation: Beer Yaakov Mental Health Center
name: Ilana Vaintraub, MD
role: PRINCIPAL_INVESTIGATOR
References: