louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00936260: Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis
Official title: Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: osteoporosis
postmenopausal
alendronate
Lead sponsor: Ciudad Universitaria, Spain
Sponsor class: OTHER
First posted: 2009-07-10
Enrollment: 228
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the duration of the treatment with alendronate in postmenopausal women with osteoporosis.

Detailed description: The duration of the treatment with alendronate is not well established. The investigators recruited 228 women with postmenopausal osteoporosis. They all received alendronate during the first 3 years of monitoring and were later on randomized to whether different regimens of intermittent treatment or to carry on 3 years more.

Eligibility criteria: Inclusion Criteria:

* postmenopausal osteoporosis under densitometric criteria of the World Health Organization

Exclusion Criteria:

* secondary osteoporosis
* alteration in analytic parameters (total proteins, calcium, phosphorus, vitamin D, parathyroid hormone, thyroid hormone, transaminase, creatinine)

Primary outcomes:
measure: Bone mineral density
timeFrame: Every year
Secondary outcomes:
measure: Fractures
timeFrame: Every year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: University San Carlos Hospital
Study officials:
affiliation: university san carlos hospital
name: Carlos Lozano Tonkin, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05278260: Hydrogen-rich Water and Treatment of Mucositis Caused by Radiation Therapy in Head and Neck Cancer Patients
Official title: Hydrogen Rich Water to Mitigate Acute Mucositis During Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Mucositis Oral
Keywords: head and neck cancer
radiation therapy
supportive care
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: DrinkHRW
First posted: 2022-03-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study explores the effects of hydrogen-rich water on alleviating the radiation-induced acute mucositis in head and neck cancer patients


Eligibility criteria: Inclusion Criteria:

* Diagnosis of a biopsy proven head and neck cancer, early or advanced stage, primary or recurrent tumor,
* Planning to receive daily fractionated radiotherapy for over 4 weeks' duration
* Karnofsky Performance Score (KPS) of at least 70
* Able to describe pain
* Able to swallow food and water
* Able to sign consent

Exclusion Criteria:

-

Primary outcomes:
measure: Number of participants who develop grade 3 oropharyngeal mucositis
timeFrame: 3 months after completing radiation therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook Cancer Center
state: New York
Study officials:
affiliation: Stony Brook University
name: Kartik Mani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01984060: Feasibility of an Exercise Intervention
Official title: Feasibility of an Exercise Intervention In HIV+ Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Aging
Physical Activity
Physical Function
HIV
Frailty
Autonomous Motivation
Depression
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2013-11-14
Enrollment: 74
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall purpose of this research is to evaluate the effect of a home-based exercise program on physical function and to improve the health and quality of life for the HIV-infected older adult community.

Detailed description: Subjects are being asked to participate in this study if they are infected with the human immunodeficiency virus (HIV), and they are 45 years of age or older.

Eligibility criteria: Inclusion Criteria:

* HIV positive, both genders, all races, English speaking individuals, age 45 years or older, on HAART before enrollment. .

Exclusion Criteria:

* Subject will be excluded if he/she has history or currently has severe cardiopulmonary illness, severe orthopedic or neuromuscular impairments, significant cognitive or sensory impairments, history of active malignancy, untreated depression, manic or psychotic disorder, and normal PPT score.

Primary outcomes:
measure: Change in Feasibility
timeFrame: At day zero of the study and after 12 weeks of intervension.
Secondary outcomes:
measure: Change in Efficacy
timeFrame: At day zero of the study and after 12 weeks of intervension.
measure: Change in Autonomy
timeFrame: At day zero of the study and after 12 weeks of intervension.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester/ Strong Memorial Hospital
state: New York
Study officials:
affiliation: University of Rochester
name: Krupa Shah, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah KN, Majeed Z, Yoruk YB, Yang H, Hilton TN, McMahon JM, Hall WJ, Walck D, Luque AE, Ryan RM. Enhancing physical function in HIV-infected older adults: A randomized controlled clinical trial. Health Psychol. 2016 Jun;35(6):563-73. doi: 10.1037/hea0000311. Epub 2016 Feb 11.
Clinical trial NCT03103360: Pupillary Pain Index and Reaction to Skin Incision
Official title: Relationship Between the Pupillary Pain Index Measured One Minute Before Incision and the Motor, Hemodynamic and Electroencephalographic Reaction to Skin Incision in Patients Under General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Anesthesia
Surgery
Lead sponsor: Hôpital Armand Trousseau
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 53
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children under general anesthesia for an elective or emergent surgery requiring a skin incision in a body area not covered by regional anesthesia

Brief summary: During routine general anesthesia (not standardized, left to the discretion of the attending anesthesiologist), pupillary pain index was measured one minute before skin incision. Then, variations in heart rate, blood pressure and bispectral index during the three minutes following skin incision were recorded, as well as the occurrence of movements.


Eligibility criteria: Inclusion Criteria:

* patient requiring general anesthesia
* surgical procedure involving a skin incision
* no regional anesthesia
* written informed consent

Exclusion Criteria:

- neurologic or ophthalmic disease

Primary outcomes:
measure: Relationship between pre-incision pupillary pain index and post-incision heart rate increase
timeFrame: 4 minutes: one minute before incision, 3 minutes after incision
measure: Relationship between pre-incision pupillary pain index and post-incision blood pressure increase
timeFrame: 4 minutes: one minute before incision, 3 minutes after incision
measure: Relationship between pre-incision pupillary pain index and post-incision bispectral index increase
timeFrame: 4 minutes: one minute before incision, 3 minutes after incision
measure: Relationship between pre-incision pupillary pain index and post-incision movement occurrence
timeFrame: 4 minutes: one minute before incision, 3 minutes after incision
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Departement d'anesthesie Hopital Armand Trousseau
Study officials:
affiliation: University Hospital Armand Trousseau
name: Isabelle Constant, MD-PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01081860: Stiffness of the Skin and Joints in Relation to Carpal Tunnel Syndrome
Official title: Correlation of Joint Stiffness and Stiffness of the Skin and the Prevelation of Carpal Tunnel Syndrome (CTS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal tunnel syndrome
CTS
Skinstiffness
Jointstiffness
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2010-03-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting with complaints of:

* Carpal tunnel syndrome
* Trigger finger
* Dupuytren contracture
* an acute trauma to the hand

Brief summary: The exact etiology of CTS remains yet unknown. A rise in carpal tunnel pressure is well documented, but why this phenomenon occurs is yet unknown in most patients. There is an absolute or relative narrowing of the carpal tunnel, which results in a compression of the median nerve.

The investigators postulate, that a stiffer flexor retinaculum (roof of carpal tunnel) will be less compliant. As a consequence of this stiffer retinaculum the pressure in the carpal tunnel will rise more quickly in stiff patients resulting in CTS-complaints.

A relation between connective tissue composition and joint stiffness is proven. This relationship possibly extends to a relation between stiffness of the skin, joint stiffness and the prevalence of CTS.


Eligibility criteria: Inclusion Criteria:

* Caucasian
* Carpal tunnel release OR Trigger finger OR Dupuytren OR an acute trauma to the hand

Exclusion Criteria:

* Hypo-/hyperthyroidism
* Diabetes
* Arthritis
* Pregnancy
* Obesity (BMI \>30)
* Anatomical anomalies

Primary outcomes:
measure: Joint stiffness
timeFrame: In the 1st month
measure: Stiffness of the skin
timeFrame: in the 1st month
Secondary outcomes:
measure: Physical activities
timeFrame: In the 1st month
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St Antonius Hospital
state: Utrecht
Study officials:
affiliation: St. Antonius Hospital
name: A.B. Mink van der Molen, dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00557960: ADDERALL XR (Mixed Salts of a Single-entity Amphetamine) and STRATTERA ( Atomoxetine Hydrochloride) Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With ADHD
Official title: A Phase IIIb Study to Evaluate the Efficacy and Time Course of Treatment With ADDERALL XR and STRATTERA Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2007-11-14
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Evaluate the efficacy of treatment with ADDERALL XR and STRATTERA compared to placebo on simulated driving safety and performance of young adults with ADHD as measured by Driving Safety Scores derived by the Driving Simulator.


Eligibility criteria: Inclusion Criteria:

* primary diagnosis of ADHD
* not naive to pharmacologic ADHD treatment
* valid driver's license with a minimum of 3 years driving experience

Exclusion Criteria:

* recent history of drug dependence or substance use disorder
* any specific cardiac condition that would, in the opinion of the investigator, require exclusion
* history of seizure in last 2 years, tic disorder or Tourette's disorder
* female subject is pregnant or lactating

Primary outcomes:
measure: Overall Driving Safety Score derived by the driving simulator
timeFrame: Weeks 3 & 6
Secondary outcomes:
measure: Driving Safety Scores at individual time points
timeFrame: 2, 7, and 12 hours post-dose at Weeks 3 & 6
measure: Cog-Screen Aviator Predictor Score, ADHD-RS, CGI, Self-rating of driving simulator performance questionnaire
timeFrame: Weeks 3 & 6
measure: AEs, laboratory screens, PE, vital signs, ECG
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Neuropsychological Institute, LLC
state: District of Columbia
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Kay GG, Michaels MA, Pakull B. Simulated driving changes in young adults with ADHD receiving mixed amphetamine salts extended release and atomoxetine. J Atten Disord. 2009 Jan;12(4):316-29. doi: 10.1177/1087054708322986. Epub 2008 Sep 24.
Clinical trial NCT02158260: A New Method To Reduce Gastric Missing Areas in Capsule Endoscopy
Official title: A New Method To Reduce Gastric Missing Areas in Capsule Endoscopy: a Single Center, Prospective and Self-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Capsule Endoscopy
Keywords: Capsule endoscopy
Patient position changing
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2014-06-06
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: It is a single center, prospective and self-controlled trial. We'd like to explore a new method by changing position to reduce gastric missing areas in Capsule Endoscopy(CE)

Detailed description: Background:Capsule endoscopy is widely used to observe small intestine.While it may miss important areas in stomach，especially in fundus.So far,physicians have no methods to observe stomach without no-missing areas by capsule endoscopy.

Objective:To explore a new method to reduce the areas missed by CE.

Methods:Subjects were prospectively enrolled.Every subjects will undergo 2 capsule endoscopies and 1 gastroscope.First capsule endoscopy,every subject have a better gastric preparation before swallowing CE and change position during the procedure.Second capsule endoscopy,every subject have a conventional CE. And then, every subject have a gastroscope.

Measurements:The primary measurements included safety, gastric preparation, visualization of gastric mucosa and rate of lesion detection.

Eligibility criteria: Inclusion Criteria:

* Subjects don't have swallowing difficulties, motility disorders, or a medical history that included abdominal surgery or obvious gastrointestinal strictures are included.

Exclusion Criteria:

* Subjects with swallowing difficulty, motility disorders, diabetes, life-threatening conditions, mental disorders, or patients that could be pregnant, have a cardiac pacemaker, electrical implant, or any other condition that would preclude compliance with the study requirements and/or device instructions are excluded from the study.

Primary outcomes:
measure: visualization of gastric mucosa
timeFrame: 1 year
Secondary outcomes:
measure: rate of lesion detection
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Side Liu, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00673660: Observational Study On Compliance Of Statin Treatment Of Patients With High Blood Cholesterol Levels
Official title: Assessment Of Statin Treatment Compliance In Dyslipidemia Patients: An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemia
Keywords: Statins
Compliance
Dyslipidemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-05-07
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with dyslipidemia and taking or planning to take statin treatment. Patients living in the same city of the study center. Patients aged 18 years old and over.

Brief summary: The purpose of the study is to show the compliance rates of the patients to statin treatment and the reasons of non-compliance.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with dyslipidemia and taking or planning to take statin treatment.
* Patients living in the same city of the study center. o Patients aged 18 years and over.

Exclusion Criteria:

* Patients with severe systemic disease
* Patients with alcohol and drug addiction and/or mental disease
* Patients nursing or pregnant, or planning to get pregnant during the study

Primary outcomes:
measure: Percentage of Participants Who Were Compliant With Statin Treatment
timeFrame: Month 12
Secondary outcomes:
measure: Available Lipid Profiles of Compliant and Non-compliant Participants
timeFrame: Month 12
measure: Number of Participants With Reasons of Compliance to Statin Treatment
timeFrame: Month 12
measure: Number of Participants With Reasons of Non-compliance to Statin Treatment
timeFrame: Month 12
Other outcomes:
Locations:
city: Mecidiyekoy
country: Turkey
facility: Pfizer Investigational Site
state: Istanbul
city: Bolu
country: Turkey
facility: Pfizer Investigational Site
city: Haseki/Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01898260: Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses
Official title: Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Refractive Error
Keywords: contact lenses
daily disposable contact lenses
silicone hydrogel
contact lens comfort
near-sighted
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-07-12
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to compare the subjective performance of two daily disposable contact lenses with respect to comfort and handling.


Eligibility criteria: Inclusion Criteria:

* Adapted soft contact lens wearer;
* Spherical distance contact lens prescription between -1.00 and -6.00 diopter (inclusive);
* Spectacle cylinder ≤0.75 diopter in the least astigmatic eye, ≤1.00 diopter in the other;
* Correctable to 6/9 (20/30) in both eyes;
* Read, understood and signed the informed consent;
* Willing to comply with the wear schedule;
* Willing to comply with the study visit schedule;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any active corneal infection, injury or inflammation;
* Systemic or ocular allergies which might interfere with contact lens wear;
* Systemic or ocular disease which might interfere with contact lens wear;
* Strabismus or amblyopia;
* Corneal refractive surgery and any anterior segment surgery;
* Use of systemic/topical medication contraindicating contact lens wear;
* Use of gas permeable contact lenses within 1 month preceding the study;
* Participation in any concurrent clinical trial or in the last 30 days;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Initial Comfort
timeFrame: Baseline
Secondary outcomes:
measure: End of Day Comfort
timeFrame: Day 7
measure: Overall Comfort
timeFrame: Day 7
measure: Overall Handling at Time of Removal
timeFrame: Day 7
Other outcomes:
Locations:
city: Surrey
country: United Kingdom
facility: Alcon Investigative Site
Study officials:
affiliation: Alcon Research
name: Joachim Nick, Dipl. Ing.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03553160: Caloric Titration Method of Weight Loss and Maintenance
Official title: Caloric Titration Method of Weight Loss and Maintenance in the Cornell Community: A Longitudinal Analysis of Psychological Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Cornell University
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Study examined the effectiveness of daily self-weighing to prevent age related weight gain.

Detailed description: Were given scales to weigh themselves daily. Change in weight was measured at the beginning and end of the two year observation period.

Eligibility criteria: Inclusion Criteria:

* over the age of 18
* not pregnant
* not trying to gain or lose weight

Exclusion Criteria:

* diabetes
* history of an eating disorder
* Body Mass Index (BMI) greater than 27.0 kg/m2.

Primary outcomes:
measure: Prevention of age related weight gain by weighing daily
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ithaca
country: United States
facility: Dorms or student houseing
state: New York
Study officials:
References: