louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00000910: A Study to Collect Information About HIV-Positive Pregnant Women and Their Babies
Official title: Medical Chart Abstraction of HIV-Infected Pregnant Women and Their Infants Receiving Care or Consultation at Study Sites
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Pregnancy
Keywords: Pregnancy
Anti-HIV Agents
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2001-08-31
Enrollment: 2000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to collect medical information about HIV-positive pregnant women and their babies who have been (or are being) seen at study sites. This information will be used to help design future research studies for these patients.

The population of HIV-positive pregnant women and their babies who are seen at study sites has not been officially examined. In order to design future studies to research the best care for these patients, this study will examine important characteristics and the general number of women in these trials.

Detailed description: The population served at affiliated ACTG sites has not been officially described. Anecdotal evidence, however, has surfaced regarding the characteristics of HIV-infected pregnant women and the current standard of care during pregnancy. This chart abstraction study is designed to define, more accurately, the pertinent characteristics and general numbers of women in these trials.

In this medical chart abstraction study, pertinent information is collected on all HIV-infected pregnant women and their infants who receive primary or consultative care at PACTG 367 study sites. Part A profiles all HIV-infected women who received care or consultation at study sites and who had a pregnancy outcome between January 1, 1998 through July 1, 1998. \[AS PER AMENDMENT 04/12/02: Part A is closed to enrollment.\] Part B profiles HIV-infected pregnant women who receive primary or consultative care and a pregnancy outcome following July 1, 1998.

Eligibility criteria: Inclusion Criteria

A patient may be eligible for this study if she:

* Is an HIV-positive woman.
* Is receiving care at a study site during the study period or her infant is receiving care at a study site and whose delivery information is available.
* Had a baby on or after January 1, 1998.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hosp., Div. of Infectious Disease
state: Massachusetts
city: Newark
country: United States
facility: Rutgers - New Jersey Medical School CRS
state: New Jersey
Study officials:
name: Ruth Tuomala
role: STUDY_CHAIR
name: Renee Samelson
role: STUDY_CHAIR
References:
Clinical trial NCT00376610: Prospective Clinical Evaluation of ASR/Re-Cap Resurfacing Arthroplasty
Official title: Prospective Clinical Evaluation of ASR/Re-Cap Resurfacing Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bearings
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2006-09-15
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: ASR/Re-cap versus 28 MoM


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of THA
* ASA I-II
* Willing to return for follow-up evaluations

Exclusion Criteria:

* Collum femurs \< 2 cm
* Cysts \> 1 cm
* Caput necrose

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Frederiksberg University Hospital
state: Copenhagen
Study officials:
affiliation: Frederiksberg Univesity Hospital
name: Arne Borgwardt
role: STUDY_DIRECTOR
References:
Clinical trial NCT01875510: The Influence of Fish-oil Lipid Emulsions on Neonatal Morbidities
Official title: The Effect of Fish-oil Lipid Emulsions on Neonatal Cholestasis and Retinopathy of Prematurity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinopathy of Prematurity
Neonatal Cholestasis
Lead sponsor: Dr. Sami Ulus Children's Hospital
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Docosahexaenoic acid (DHA) has been shown to be particularly important for fetal and neonatal development. Infants born prematurely are at special risk for DHA insufficiency. The source of DHA after birth for preterm babies who are not fed full enterally, are mostly fat emulsions as the component of total parenteral nutrition solutions which usually do not contain DHA. The aim of this study is to investigate if the fish oil emulsion-administered from the first day of life and during parenteral nutrition-prevents infants from cholestasis and retinopathy of prematurity.

Detailed description: During the study period, preterm infants admitted to NICU were included. Infants who weighed \<1500 gr and delivered prematurely before the 32nd week of gestation were eligible for the study. Infants with major congenital anomalies, congenital infections and inborn metabolic errors were excluded from the study.

Group 1: Fish-oil emulsion (20% SMOFLipid: soybean oil 60 g/dL, MCT 60 g/dL, olive oil 50 g/dL, fish oil 30 g/dL, egg phospholipids 12 g/dL, glycerol 25 g/dL, vitamin E 200 mg α-TE/L) Group 2: Soybean oil emulsion (20% Intralipid: soybean oil 200 g/dL, egg phospholipids 12 g/dL, glycerol 22,5 g/dL, vitamin E 57 mg α-TE/L).

Eligibility criteria: Inclusion Criteria:

* Infants below 32 gestational age and requiring parenteral nutrition

Exclusion Criteria:

* Infants with congenital anomalies, infants above 32 gestational age

Primary outcomes:
measure: Number of Participants With Retinopathy of Prematurity
timeFrame: Corrected age 32 weeks or postnatal 28th day
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dr. Sami Ulus Childrens Hospital
Study officials:
affiliation: Dr. Sami Ulus Children's Hospital
name: Serdar Beken
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pawlik D, Lauterbach R, Turyk E. Fish-oil fat emulsion supplementation may reduce the risk of severe retinopathy in VLBW infants. Pediatrics. 2011 Feb;127(2):223-8. doi: 10.1542/peds.2010-2427. Epub 2011 Jan 3.
Clinical trial NCT05553210: Internet-Based Stress Recovery Program FOREST+ for Healthcare Workers
Official title: Effects of Intervention Plan on Outcomes of Stress Recovery Program FOREST+ for Healthcare Workers: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Lead sponsor: Vilnius University
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2022-09-23
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated either to the intervention or control groups. The intervention group will use the intervention with an intervention plan and the control - without an intervention plan. Both groups will participate in the program at the same time.
Primary purpose: TREATMENT

Brief summary: The study aims to assess the efficacy of an internet-based stress recovery intervention for healthcare workers receiving therapist support with or without an intervention plan.

Detailed description: The intervention will be delivered as an internet-based stress recovery program for healthcare workers, comprising of six modules: introduction, psychological detachment, distancing, mastery, control, and keeping the change alive. These modules have been chosen after considering themes that could be most useful for healthcare workers under high stress. Each module consists of a psychoeducational and an exercise component. An intervention plan will be drawn up with the therapist prior to the start of the program, setting the intensity of engagement and the frequency of reminders. During the program, a therapist provides individual feedback on the completed exercises and can also be available on request.

The effect of the intervention will be compared with a control group that will use the program without an intervention plan. The intervention will be delivered in Lithuanian.

Eligibility criteria: Inclusion Criteria:

* licensed healthcare professionals currently working under license;
* at least 18 years old;
* comprehending Lithuanian language;
* access to internet.

Exclusion Criteria:

* acute psychiatric crisis;
* high suicide risk;
* interpersonal violence.

Primary outcomes:
measure: Change on Recovery Experience Questionnaire
timeFrame: Pre-treatment, post-treatment (after 6 weeks), 6 months follow-up
Secondary outcomes:
measure: Change on Perceived Stress Scale
timeFrame: Pre-treatment, post-treatment (after 6 weeks), 6 months follow-up
measure: Change on Patient Health Questionnaire
timeFrame: Pre-treatment, post-treatment (after 6 weeks), 6 months follow-up
measure: Change on Well-being Index
timeFrame: Pre-treatment, post-treatment (after 6 weeks), 6 months follow-up
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University
Study officials:
affiliation: Vilnius University
name: Evaldas Kazlauskas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03454581: Effectiveness of Photobiomodulation and Manual Therapy Alone or Combined in TMD Patients
Official title: Comparative Effectiveness of Photobiomodulation and Manual Therapy Alone or Combined in TMD Patients: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Temporomandibular Disorder
Keywords: Temporomandibular Diseases
Photobiomodulation
Low level laser
Treatment
Manual Therapy
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 51
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to investigate the effect of photobiomodulation (PBM) and manual therapy (MT) isolated or combined in the reduce of pain, the improve of mandibular movements, the psychosocial aspects and the anxiety symptoms of patients with TMD.

Detailed description: Temporomandibular disorders (TMD) is a complex and multifactorial disease. Therapeutic modalities, as PBM and MT, expected to relief of symptoms, improve of function and reduce the impact of the disease in patient's life. Fifty-one TMD patients were randomly allocated to three groups: PBM group (n=18) using 808 nm, 100 milliwatt (mW), 13.3 J ∕cm2, 4 J per point), MT group (n=16) with 21 minutes sessions of MT of the masticatory muscles and TMJ and Combined Therapy group (CT) (n=17) applying the 2 protocol described above. All treatments were done three times a week for four consecutive weeks. Evaluations were performed at baseline, during the treatment (days 7, 14, 21, and 28) and follow up (day 60 and day 90). Visual analogue scale (VAS), Research Diagnostic Criteria (RDC/TMD) Axis I and II, Beck anxiety inventory (BAI) were used in different moments of evaluation time.

Eligibility criteria: Inclusion Criteria:

* TMD myogenic and arthrogenic diagnosis based in RDC/TMD Axis I analysis
* Pain in temporomandibular joint (TMJ)
* Limitation in mouth opening.

Exclusion Criteria:

* Current dental or physical treatment
* Polyarthritis and other rheumatic diseases
* Use of anti-inflammatory and muscle relaxant

Primary outcomes:
measure: Change From Baseline in Visual Analogic Scale (VAS) for Pain
timeFrame: 0,7,14,21,28,60,90 days
Secondary outcomes:
measure: Change at Jaw Movements
timeFrame: 0,28,90 days
measure: Change on Chronic Pain Grades
timeFrame: 0,90 days
measure: Changes on Levels of Depression Symptoms
timeFrame: 0,90 days
measure: Change on Nonspecific Physical Symptoms With Pain
timeFrame: 0, 90 days
measure: Change on Nonspecific Physical Symptoms Without Pain
timeFrame: 0, 90 days
measure: Changes on Mandibular Function
timeFrame: 0, 90 days
measure: Changes on Levels of Anxiety
timeFrame: 0,90 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00237081: Genetics of Interstitial Cystitis
Official title: Maryland Genetics of Interstitial Cystitis (MaGIC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Cystitis
Painful Bladder Syndrome
Keywords: Interstitial Cystitis
Painful Bladder Syndrome
Genetics
Risk factors
Family history
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2005-10-12
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Time perspective: OTHER

Brief summary: The cause of interstitial cystitis is unknown. However, it tends to run in some families suggesting that there may be a genetic susceptibility to the disease. For instance, the disease is found 17 times more commonly in first-degree relatives (parent, sibling, or child) of patients with interstitial cystitis than in the general population. Furthermore, if one twin has interstitial cystitis, the disease is much more common in identical co-twins than fraternal co-twins. This evidence suggests that, in some families, genes that make a person susceptible to interstitial cystitis are being passed from one generation to the next.

The University of Maryland School of Medicine and the National Institutes of Health are performing a study to identify these genes for susceptibility for interstitial cystitis. This study is entitled the Maryland Genetics of Interstitial Cystitis (MaGIC) study. The MaGIC study will investigate several hundred families with two or more blood relatives with interstitial cystitis. The study will seek to find changes in genes that are found far more commonly in family members who have interstitial cystitis than in those who do not have the disease.Identifying these genes should lead to a better understanding of the cause of interstitial cystitis. Finding the cause is the first step to finding the cure.

This is a national study which is conducted by telephone and mail, and in which you can participate entirely from your home.


Eligibility criteria: Inclusion Criteria:

* Have interstitial cystitis, or painful bladder syndrome.
* Have at least one blood relative with interstitial cystitis, painful bladder syndrome, or urinary symptoms similar to yours.
* Are 13 years of age or older.
* Are available for a telephone, mail, or website interview.
* Live in the USA or Canada.

Exclusion Criteria:

* Are less than 13 years of age.
* Have Parkinson's disease, Multiple Sclerosis, Spina bifida, or another neurologic disease that preceeded your interstitial cystitis symptoms

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Interstitial Cystitis Center
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: John W Warren, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05936281: A Study of the Efficacy of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering (GenSci048-202)
Official title: A Randomized, Open-lable, Multi-center, Active-controlled Phase 2 Study for Evaluating Efficacy and Safety of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gout
Gout Initiating Urate-loweringUrate-lowering Therapy
Keywords: Gout
urate-loweringUrate-lowering therapy
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Huashan Hospital
First posted: 2023-07-07
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Gout patients initiating urate-lowering therapy Group A: Genakumab 100mg single injection; Group B: Genakumab 200mg single injection;Group C: Oral colchicine 0.5mg once a day for 12 weeks
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of Genakumab in prevention of acute flares in gout patients initiating urate-lowering therapyurate-lowering

Detailed description: A randomized, open-lable, multi-center, active-controlled Phase 2 study. Patients are randomized to Genakumab 100mg single injection group, Genakumab 200mg single injection group or oral colchicine 0.5mg once a day.for 12 weeks group.

Eligibility criteria: 1. Signed written informed consent before any study procedure is performed.
2. Male or female, 18 years ≤ age ≤ 75 years.
3. BMI ≤ 40kg/m2.
4. Confirmed diagnosis of gout meeting the American College of Rheumatology (ACR) 2015 preliminary criteria for the classification of arthritis of primary gout.
5. History of ≥2 gout flare within 12 months prior to screening.
6. Willingness to initiate urate-lowering therapy or having initiated urate-lowering therapy within 1 week prior to screening

Primary outcomes:
measure: Mean Number of Gout Flares Per Participant
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Proportion of Participants With at Least 1 Gout Flare Within 12 Weeks After Randomization
timeFrame: Baseline to Week 12
measure: Time from Randomization to the First Flare
timeFrame: Baseline to Week 12
measure: Mean duration of flares
timeFrame: Baseline to Week 12
measure: 5. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Baseline to Week 12
Other outcomes:
measure: 6. Immunogenic Outcome The incidence of anti-drug antibodies and the incidence of neutralizing antibody
timeFrame: Baseline to Week 12
Locations:
city: Shanghai
country: China
facility: Fudan University Affiliated Huashan Hospital
state: Shanghai
Study officials:
affiliation: Fudan University Affiliated Huashan Hospital
name: Hejian Zou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01070381: Daily Disposable Toric Comparative Trial in Europe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Astigmatism
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-02-18
Enrollment: 220
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the subjective and objective performance of two daily disposable lenses for wearers with astigmatism.


Eligibility criteria: Inclusion Criteria:

* Current soft contact lens wearers able to be fit with soft toric lenses in the protocol-specified parameters.
* Achieve 0.5 or better distance visual acuity in each eye at time of dispense.
* Achieve acceptable or optimal fit in each eye at time of dispense.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Habitual daily disposable contact lens wearer.
* Sleeps in contact lenses overnight.
* Currently enrolled in an ophthalmic clinical trial.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Overall Comfort
timeFrame: 1 week of wear
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01423981: Web Based Investigation of Natural History of Keloid Disorder, an Online Survey
Official title: Web Based Investigation of Natural History of Keloid Disorder, an Online Survey
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Keloid
Keywords: Keloid
Scar
hypertrophic scar
familial keloid
Lead sponsor: Tirgan, Michael H., M.D.
Sponsor class: INDIV
First posted: 2011-08-26
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with keloid disorder.

Brief summary: This trial intends to gather very basic clinical information about keloid, its patterns of presentation, family history, ethnic background and correlation with the type of keloid, as well as prior treatment results that patients have had received.

Detailed description: This will be a web based study, whereby patients will have to read and acknowledge the consent form online. Once patients agree and acknowledge the terms of the consent form, they will gain access to the questionnaire pages.

For those who are under age of 18, a parent or a legal guardian must sign the consent form and answer the online questions on behalf of the patient.

Eligibility criteria: Inclusion Criteria:

1. Patients must have clinically confirmed diagnosis of keloid
2. Adults, age over 18
3. Parent or legal guardian may participate if patient is under the age of 18
4. Able and willing to complete a web based survey

Exclusion Criteria:

* No one will be excluded from this study as long as the inclusion criteria are met.

Primary outcomes:
measure: Determine the prevalence different phenotypes of keloid in participants.
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Michael H. Tirgan, MD
state: New York
Study officials:
affiliation: Keloid Research Foundation
name: Michael H Tirgan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01001481: Schizophrenia Treatment Adherence Investigation (STAI)
Official title: Clinical Audit and Feedback Program to Determine Risk for Medication Adherence in Outpatients Diagnosed With Schizophrenia in Australia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Treatment review
Schizophrenia
Observational
Prospective studies
Australia
Lead sponsor: Janssen-Cilag Pty Ltd
Sponsor class: INDUSTRY
First posted: 2009-10-26
Enrollment: 550
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: Outpatient clinics

Brief summary: The primary objective of this treatment review and feedback program is to quantify the risk status for medication adherence in a cohort of Australian patients diagnosed with schizophrenia.

Detailed description: The primary objective of this treatment review and feedback program is to quantify the risk status for medication adherence in a cohort of Australian patients diagnosed with schizophrenia. Observational study - no study drug administered

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of schizophrenia or schizoaffective disorder according to DSM-IV
* Currently treated in an outpatient clinic
* Able to provide informed consent
* Concurrent enrolment in clinical trials is acceptable
* Have completed all questions on the Drug Attitude Inventory (DAI-10) and Medication Adherence Rating Scale (MARS) survey

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Primary outcome measure is the Clinical Assessment of Adherence as rated by the Investigators
timeFrame: 6 months, 12 months
Secondary outcomes:
measure: Clinical exacerbations (worsening of symptoms)
timeFrame: 6 mths, 12 mths
measure: Medication changes
timeFrame: 6 mths, 12 mths
Other outcomes:
Locations:
Study officials:
affiliation: Janssen-Cilag Pty Ltd
name: Janssen-Cilag Pty Ltd Clinical Trial
role: STUDY_DIRECTOR
References: