louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01808963: Evaluation of Respiratory Heast Loss as a Physiologic Patient Monitor for Acute Care Medicine
Official title: Evaluation of Respiratory Heat Loss as a Physiologic Patient Monitor for Acute Care Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Heat Loss
Keywords: Enthalpy
Physiologic Monitors
Critical Care Medicine
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2013-03-12
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient undergoing elective surgery requiring arterial pressure monitoring.

Brief summary: To evaluate the utility of respiratory heat loss measurements as a physiologic monitor.

Detailed description: Respiratory Heat Loss Measured in Joules Per Minute

Eligibility criteria: Inclusion Criteria:

* Elective surgical procedures.

Exclusion Criteria:

* Severe pulmonary disease.

Primary outcomes:
measure: Evaluation of Respiratory Heat Loss as a Physiologic Patient Monitor for Acute Care Medicine
timeFrame: 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: Director, Cardiovascular and Thoracic Anesthesiology
name: Neal W Fleming, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01659463: Resin Infiltratration on the Sealing of Proximal Early Caries
Official title: Resin Infiltration on Teh Sealing of Proximal Early Caries Lesins: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth; Lesion, White Spot Lesions
Keywords: CARIES INFILTRATION
CARIES LESION
INFILTRANT
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
First posted: 2012-08-07
Enrollment: 39
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Material for caries prevention dont have better results compared with non-operatory interventions.

Detailed description: Two gruops will be compared. One using ICON and another gruop with non-operatory interventions consisted in hygiene instrutions and fluoride topical application. The caries progression will be evalueted with radiographic observation.

Eligibility criteria: Inclusion Criteria:

* Two early caries lesion in the same patient, lesion with the same radiolucencies images

Exclusion Criteria:

* Pregnancy, use of orthodontics appliences, use of drugs modified salivar flow, ausence of adjacent teeth

Primary outcomes:
measure: caries progression in the proximal surfaces
timeFrame: One year after interventions
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: Federal University of Santa Maria
state: Rio Grande Do Sul
Study officials:
affiliation: Universidade Federal de Santa Maria
name: Julio E Zenkner, MsC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00447863: Study Evaluating the Bioequivalence of Levonorgestrel/Ethinyl Estradiol Combinations in Cycling Women
Official title: An Open-Label, Single-Dose, Randomized, 2-Period, Crossover, Bioequivalence Study to Compare Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg in 2 Dosage Forms With Different Dissolution Characteristics in Healthy, Cycling Women
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Contraception
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-15
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Levonorgestrel/ethinyl estradiol (LNG/EE) is an investigational drug that is being developed as an oral contraceptive (birth control pill). The purpose of this trial is to compare different preparations of LNG/EE by assessing the way they are absorbed into the blood.


Eligibility criteria: Inclusion Criteria:

* Women aged 18 to 35 years.
* Healthy as determined by the investigator on the basis of medical history and screening evaluations.
* Must have a history of normal menstrual cycles (24 to 34 days) for the 3-month period preceding entry into the study.

Exclusion Criteria:

* Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article.
* Presence, history, or family history of thrombophlebitis, thrombosis, or thromboembolitic disorders, deep vein thrombosis, pulmonary embolism, or known coagulopathy.
* Bethesda system report of low-grade squamous intraepithelial lesion or greater for a cervical cytologic smear obtained within the last 3 months.

Primary outcomes:
measure: To assess the bioequivalence of 2 batches of LNG/EE tablets with different dissolution characteristics
Secondary outcomes:
measure: To obtain additional safety and tolerability data concerning LNG/EE in healthy, cycling women
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00831363: Minimal Invasive Versus Traditional Transgluteal Approach in Total Hip Arthroplasty: a Comparative Gait Analysis
Official title: Minimal Invasive Versus Traditional Transgluteal Approach in Total Hip Arthroplasty: a Comparative Gait Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Hip Arthroplasty
Keywords: gait analysis
minimal invasive approach
transgluteal approach
THA
Lead sponsor: Orthopedic Hospital Vienna Speising
Sponsor class: OTHER
First posted: 2009-01-28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The hypothesis for the present study was that patients receiving a minimally invasive total hip arthroplasty will show a faster improvement on walking ability and mobilization in the immediate postoperative period compared to patients with the standard Hardinge approach. Therefore, the main goal was to evaluate the differences in early rehabilitation of these two different surgical approaches by gait analysis and electromyographical examination as objective methods.


Eligibility criteria: Inclusion Criteria:

* unilateral osteoarthritis of the hip
* BMI below 30

Exclusion Criteria:

* previous surgery on the evaluated hip,
* previous arthroplasties on other joints,
* a leg length discrepancy of more than 0.5cm,
* rheumatoid osteoarthritis
* decreased mobility due to non joint related factors

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Orthopedic Hospital Speising
Study officials:
References:
Clinical trial NCT05771363: Frequency and Risk Factors for Autoimmune Disorders and Rheumatic Manifestations in Egyptian Patients With IBD
Official title: Frequency and Risk Factors for Autoimmune Disorders and Rheumatic Manifestations in Egyptian Patients With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: IBD
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cross-sectional studies are observational studies that analyze data from a population at a single point in time. They are often used to measure the prevalence of health outcomes, understand determinants of health, and describe features of a population. Unlike other types of observational studies, cross-sectional studies do not follow individuals up over time. They are usually inexpensive and easy to conduct. They are useful for establishing preliminary evidence in planning a future advanced study. This article reviews the essential characteristics, describes strengths and weaknesses, discusses methodological issues, and gives our recommendations on design and statistical analysis for cross-sectional studies in pulmonary and critical care medicine. A list of considerations for reviewers is also provided.

Brief summary: To examine the prevelance of autoimmune disorders and rheumatic manifestations in egyptian patients with inflammatory bowel diseases,and asses the relation between prevelance of autoimmune disorders ,rheumatic manifestations and disease activity of IBD


Eligibility criteria: Inclusion Criteria:

* 1-adult patients with adiagnosis of IBD according to the validated criteria. 2-patients\>18 years without aprevious diagnosis of SPA or other rheumatological manifestations.

Exclusion Criteria:

* 1- patients with active cancer or lymphoproliferative disease. 2-patients with uncontrolled diabetes. 3-patients with unstable ischeamic heart disease or congestive heart failure. 4-patients with acute renal failure. 5-patients already diagnosed with inflammatory or crystal induced arthropathies (including gout and calcium pyrophosphate dehydrate deposition disease) or other autoimmune diseases.

Primary outcomes:
measure: frequency and risk factors for autoimmune disorders and rheumatic manifestations in Egyptian patients with inflammatory bowel diseases.
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lanna CC, Ferrari Mde L, Rocha SL, Nascimento E, de Carvalho MA, da Cunha AS. A cross-sectional study of 130 Brazilian patients with Crohn's disease and ulcerative colitis: analysis of articular and ophthalmologic manifestations. Clin Rheumatol. 2008 Apr;27(4):503-9. doi: 10.1007/s10067-007-0797-5. Epub 2007 Dec 21.
Clinical trial NCT05412563: Exploring The Role Of Palliative Care In Phase 1 Enrolled Pediatric Oncology Patients
Official title: Exploring The Role Of Palliative Care In Phase 1 Enrolled Pediatric Oncology Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Quality of Life
Keywords: Palliative Care
Pediatric Oncology Patients
Caregiver
Phase I studies
Associated Distress
Hopes
Worries
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those who meet the Inclusion criteria and consent to participate

Brief summary: This study is being conducted to learn more about the patient/family experience when opting to enroll in Phase I clinical trials and their quality of life (QOL) while receiving experimental therapy. Palliative care (PC) has the potential to be beneficial for these families and further studies are needed to determine the most effective way for integration of PC into the care of patients enrolled on experimental clinical trials.

Primary Objective

* To qualitatively assess the patient and family experience, their hopes and worries and associated distress while deciding to enroll on a Phase I clinical trial.

Detailed description: Eligible Parent Research Participants (PRPs) who consent will participate in one audio recorded interview in which they are asked about 8-10 questions. The interview can be conducted in person, over the phone, or WebEx/Zoom (audio only). The interview will last about 30 to 60 minutes. PRPs can opt to complete interviews immediately or at a scheduled date that is convenient to the PRP.

Eligibility criteria: Inclusion Criteria:

* Caregiver is 18 years of age or older
* Caregiver is related to the patient in one of the following ways: biological parent, stepparent, or primary legal guardian
* If more than 1 set of parents are involved in the patient's care (e.g., 2 biologic and 2 stepparents or partners) involved, the caregiver with legal decision- making responsibilities will be eligible for participation
* Caregiver is comfortable speaking and reading English

Exclusion Criteria:

* Those who do not meet inclusion criteria

Primary outcomes:
measure: Qualitative assessment of patient and family experience
timeFrame: Up to approximately 8 months after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Cancer Institute/National Institutes of Health
state: Maryland
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Erica Kaye, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04195763: Patient Reported Outcomes in Adults With Pediatric-onset Hypophosphatasia Treated With Strensiq® (Asfotase Alfa)
Official title: A Prospective Study to Evaluate the Patient Reported Quality of Life Prior to and After Strensiq® Treatment in Adults With Pediatric Onset Hypophosphatasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypophosphatasia
Keywords: Pediatric-onset hypophosphatasia
Pediatric-onset
Hypophosphatasia
HPP
Patient reported outcome
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Xcenda, LLC
First posted: 2019-12-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female participants ≥18 years of age who have been diagnosed with pediatric-onset HPP, have been newly prescribed treatment with asfotase alfa, and are registered in the patient support program managed by OneSource will be invited to participate.

Brief summary: This observational study will evaluate the treatment effect of Strensiq (asfotase alfa) on Patient Reported Outcomes (PROs) in participants diagnosed with pediatric-onset hypophosphatasia (HPP) registered in the patient support program managed by OneSource™.

Detailed description: Participants consenting to participate in this study will be asked to complete study questionnaires by phone interviews upon consenting (Baseline), and up to 12 months following treatment initiation with asfotase alfa. Demographic and clinical characteristics of participants in the study will be characterized.

This is an observational study and no intervention will be administered. Participants will be treated in accordance with standard of care.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* Clinical diagnosis of pediatric-onset HPP
* Naïve to asfotase alfa
* Expected to begin treatment with asfotase alfa for HPP
* Registered in OneSource
* Willing and able to provide voluntary, verbal informed consent to participate in this study

Exclusion Criteria:

* Pregnant or breastfeeding
* Unable to speak and understand English
* Unable or unwilling to complete the study surveys via telephone interview at the protocol-required time points

Primary outcomes:
measure: Change From Baseline In Patient Reported Outcomes (PROs) Questionnaire Scores
timeFrame: Baseline, up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palm Harbor
country: United States
facility: Xcenda, LLC
state: Florida
Study officials:
References:
Clinical trial NCT01437163: Treatment of Androgenetic Alopecia in Males and Females
Official title: The Growth of Human Scalp Hair Mediated By Visible Red Light Laser and LED Sources.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Androgenetic Alopecia
Lead sponsor: Apira Science, Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-20
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of Low Level Laser and Light Therapy system configured in a novel product called the TopHat 655 system, for promoting hair growth in males and females diagnosed with androgenetic alopecia of the head.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of androgenetic alopecia
* Fitzpatrick Skin Phototypes I-IV
* Norwood-Hamilton IIa to V for males and Ludwig I or II for females
* Active hair loss within the last 12 months
* Willingness to refrain from using all other hair growth products or treatments
* In overall general good health as determined by the physician investigator

Exclusion Criteria:

* Photosensitivity to laser light and non-laser LED light operating at 655nms.
* Malignancy in the target treatment area
* Other forms of alopecia of the head
* Past medical history of a collagen-vascular disease, thyroid disease or other cutaneous or systemic disease that seriously effects the scalp
* Unwillingness to remove hair replacement products during the therapy sessions
* Using any medications deemed to inhibit hair growth as determined by the physician investigator

Primary outcomes:
measure: Percentage Increase of Terminal Hairs from Pre-treatment, Baseline Count
timeFrame: After 16 weeks of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Hoboken
country: United States
facility: Adolfo Fernandez-Obregon, MD
state: New Jersey
city: New York
country: United States
facility: Peter S. Halperin, MD
state: New York
city: Rochester
country: United States
facility: Raymond J. Lanzafame, MD
state: New York
city: Woodbury
country: United States
facility: Jeffrey A. Sklar, MD
state: New York
Study officials:
affiliation: Raymond J. Lanzafame, MD
name: Raymond J. Lanzafame, MD
role: STUDY_DIRECTOR
affiliation: Peter S. Halperin, MD
name: Peter S. Halperin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Adolfo Fernandez-Obregon, MD
name: Adolfo Fernandez-Obregon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Aesthetic Dermatology
name: Jeffrey A Sklar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lanzafame RJ, Blanche RR, Chiacchierini RP, Kazmirek ER, Sklar JA. The growth of human scalp hair in females using visible red light laser and LED sources. Lasers Surg Med. 2014 Oct;46(8):601-7. doi: 10.1002/lsm.22277. Epub 2014 Aug 13.
citation: Lanzafame RJ, Blanche RR, Bodian AB, Chiacchierini RP, Fernandez-Obregon A, Kazmirek ER. The growth of human scalp hair mediated by visible red light laser and LED sources in males. Lasers Surg Med. 2013 Oct;45(8):487-95. doi: 10.1002/lsm.22173.
Clinical trial NCT05803863: Efficacy Comparison of 2 Low-dose Atropine Eye Drops in Vietnamese Children Myopia Management
Official title: Efficacy Comparison of 2 Low-dose Atropine Eye Drops in Vietnamese Children Myopia Management
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Myopia
Keywords: myopia control
low-dose atropin
Vietnamese children
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 108
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, comparative, open label
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the efficacy of 2 low-dose atropine drops (0,01%; 0,05%) in Vietnamese children. The main questions it aims to answer are:

1. How is the difference in efficacy among 3 groups: atropine 0,01% vs 0,05% vs spectacles?
2. How is the difference in side effects among 3 groups: atropine 0,01% vs 0,05% vs spectacles?
3. How is the difference in rebound phenomena between 2 atropine groups?

Detailed description: The study is prospective, comparative, open label. Participants are Vietnamese children. Prescribing drops : 1 drops/eye/night/ 12 months Wash-out: 12 months The atropine drops in this study are commercially available.

Eligibility criteria: Inclusion Criteria:

* myopic 2 eyes (SE above from -0.75 D, astigmatism below -1.50D)
* 8 - 13 years old
* Vietnamese, speaking Vietnamese
* BCVA from 8/10 each eye

Exclusion Criteria:

* Using any contact lens in less than 3 months
* Other eye diseases than myopia
* History of eye trauma, surgeries
* Having chronic systemic diseases or having medications affecting eye.
* Having contraindications of atropine drops
* Pre-known allergies to atropine drops
* Undergoing another myopia control treatments

Primary outcomes:
measure: Efficacy (SE) of Atropine drops
timeFrame: 12 months
measure: Efficacy (AL) of Atropine drops
timeFrame: 12 months
Secondary outcomes:
measure: pupil size
timeFrame: 12 months
measure: amplitude of accommodation
timeFrame: 12 months
measure: adverse symptoms 1
timeFrame: 12 months
measure: adverse symptoms 2
timeFrame: 12 months
measure: rebound effect (SE)
timeFrame: 12 months
measure: rebound effect (AL)
timeFrame: 12 months
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: University Medical Center HCMC
Study officials:
affiliation: University of Medicine and Pharmacy at Ho Chi Minh City
name: Dung TM Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References: