louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04151303: The Optimal Timing for Cerclage Removal
Official title: The Optimal Timing for Cerclage Removal
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Disease of A Newborn
Keywords: RDS
CERCLAGE
CERVIX INSUFFICIENCY
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Women with singleton pregnancies with elective or emergent cerclage that was electively removed after 36 weeks of pregnancy.

Brief summary: Women with a history of cervical insufficiency can be managed with elective cervical cerclage placed at the beginning of the second trimester. The McDonald technique is the most commonly used. Though lack a robust scientific evidence, the cerclage is removed electively at 36-37 weeks of gestation in order to avoid maternal cervical laceration. In addition, the incidence of spontaneous delivery is nearly 20% within 72 hours after ceclage removal, thus elective cerclage removal at 36-37 weeks may also put the newborns at complications associated with iatrogenic late preterm/early term delivery

Detailed description: The optimal timing of cervical cerclage removal is yet unclear.

In the present study we will evaluate maternal and neonatal outcome variables after elective removal of the cerclage, and may suggest a gestational week cut-off for optimal cerclage removal/

Primary outcome:

Neonatal respiratory morbidity after cerclage removal. The respiratory outcome will be compared across each gestational week of delivery after cerclage removal, that is; group 1 (36-36.6 weeks), group 2 (37-37.6 weeks), group 3 (38-38.6 weeks), group 4 (beyond 39 weeks).

Secondary outcomes:

Time interval between cerclage removal and gestational age of delivery.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancies
* Elective or emergent cerclage in the current pregnancy
* Cerclage that was removed after 36 weeks of pregnancy

Exclusion Criteria:

* Multiple pregnancies
* Major congenital anomalies
* Cerclage removal before 36weeks of pregnancy

Primary outcomes:
measure: Cercalge removal and neonatal morbidity
timeFrame: 1 year
Secondary outcomes:
measure: The optimal timing for cerclage removal
timeFrame: 1 year
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam Health Care Campus
name: Yaniv Zipori, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02024503: A Longitudinal Study of Multimodal Resonance Imaging in Stroke Patients
Official title: A Longitudinal Study of Multimodal Resonance Imaging in Stroke Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: stroke
fMRI
DTI
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 800
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients with stroke and the some healthy volunteers recruited from community

Brief summary: Imaging of the ischaemic penumbra with a particular diffusion-weighted imaging (DWI)/ perfusion-weighted imaging (PWI) mismatch is a promising approach to the selection of patients with acute ischaemic stroke for trials of intervention. The investigators want to apply multimodal resonance imaging methods such as functional magnetic resonance imaging ( fMRI), diffusion tensor imaging (DTI), arterial spin labeling (ASL) to guide treatment and predict the prognosis of stroke.


Eligibility criteria: Inclusion Criteria:

Time from the onset of stroke till hospital within 24 hours. With clinical characteristics such as hemiplegia, headache. Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Patients must understand the nature of the study and give informed consent.

Exclusion Criteria:

The onset of stroke out of 24 hours. Pregnant women. Patients with intracranial metallic bodies from prior neurosurgical procedure, implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit or ventriculoperitoneal shunt.

Past history of seizures within one year or unexplained loss of consciousness. Family history of epilepsy.

Primary outcomes:
measure: Functional recovery
timeFrame: Participants will be followed till die or lost to follow-up,an expected average of three year.
Secondary outcomes:
measure: Over survival
timeFrame: Participants will be followed till die or lost to follow-up,an expected average of three year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital,Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Gao-jun Teng, Ph.D,MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00660803: Retrospective Brazilian Study of Fulvestrant in Advanced Breast Cancer
Official title: Retrospective Brazilian Study of Fulvestrant in Advanced Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Advanced Breast Cancer
Hormone Therapy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Dendrix - Scientific Information Architecture
First posted: 2008-04-17
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospitals and primary care clinics

Brief summary: Characterize the demographic and clinical features, as well as the main treatment results, among patients with advanced breast cancer treated with fulvestrant in Brazil.


Eligibility criteria: Inclusion Criteria:

* Positive HR or ER by immunohistochemistry
* Postmenopausal status at the time of treatment with fulvestrant
* Failure of at least one previous endocrine therapy before treatment with fulvestrant.

Exclusion Criteria:

* Patients who are still undergoing treatment with fulvestrant will not be eligible to participate in the study

Primary outcomes:
measure: Time to tumour progression
measure: Objective response
Secondary outcomes:
measure: Duration of treatment with fulvestrant
measure: Time and duration of response
measure: Overall survival
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Research Site
state: PE
city: Rio de Janeiro
country: Brazil
facility: Research Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Research Site
state: RS
city: Sao Paulo
country: Brazil
facility: Research Site
state: SP
Study officials:
References:
Clinical trial NCT00710203: Dermatosis Papulosa Nigra
Official title: Efficacy of a 585 nm Pulsed Dye Laser (PDL) for the Treatment of Dermatosis Papulosa Nigra, and Compare it to Therapy With Curettage and Electrodesiccation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Dermatoses
Seborrheic Keratoses
Keywords: Dermatosis Papulosa Nigra
seborrheic keratoses
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2008-07-04
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: DPN is a disorder among darkly pigmented patients, manifested by small, benign, variants of seborrheic keratoses, predominantly on the face.

The purpose of this study is to determine the efficacy of a 585 nm PDL for the treatment of Dermatosis Papulosa Nigra, and compare it to therapy with curettage (scraping the lesions off) and electrodesiccation (burning the lesions off).


Eligibility criteria: Inclusion Criteria:

* Over 18 years of age.
* Able to give informed consent.
* Desires removal of lesions.
* Willing to come back for six week follow-up.
* Willing to fill out post operative questionnaire.
* At least 4 lesions less than 7 mm.
* Diagnosis of Dermatosis Papulosa Nigra (DPN)

Exclusion Criteria:

* Less than 18 years of age.
* Pregnant.
* Sensitive to laser energy.
* History of Collagen Vascular Disorders.
* History of Keloids.
* History of post inflammatory hyperpigmentation.
* Incarcerated.
* Unable to give informed consent.
* Unable to follow up for post operative evaluation.
* Unable to complete patient visual analogue scale.
* Unable to understand consent process or risks.
* Unable to accept risk of scar, infection, minor bleeding, permanent or prolonged hyperpigmentation and hypopigmentation.

Primary outcomes:
measure: Percent Clearance of All Lesions
timeFrame: 6 to 12 weeks
Secondary outcomes:
Other outcomes:
measure: Evidence of Hypopigmentation
timeFrame: 6 to 12 weeks
measure: Evidence of Hyperpigmentation
timeFrame: 6 to 12 weeks
measure: Evidence of Scar
timeFrame: 6 to 12 weeks
measure: Evidence of Texture Irregularities
timeFrame: 6 to 12 weeks
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Department of Dermatology
state: California
Study officials:
affiliation: University of California, Davis
name: Daniel Eisen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05498103: Use of Methazolamide to Lower Intraocular Pressure
Official title: Use of Methazolamide to Lower Intraocular Pressure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Glaucoma, Open-Angle
Keywords: Glaucoma
Methazolamide
Primary Open Angle Glaucoma
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of methazolamide, 25 mg or 50 mg tablets once a day for a week than twice a day for a week, on lowering intraocular pressure and the safety of methazolamide.


Eligibility criteria: Inclusion Criteria:

* Males and females between 50 and 90 years old
* Current diagnosis of open angle glaucoma (OAG) in both eyes
* Ability to read and write in English

Exclusion Criteria:

* Glaucoma other than OAG
* Severe or end-stage glaucoma (cup to disc ratio \>0.8 or Mean Deviation on Visual Field worse than -12)
* Pregnant or breast-feeding women

Primary outcomes:
measure: Percent IOP change at each follow-up Visit
timeFrame: Day 1 (Pre-dosing, then 4- and 8- hours post dosing), Day 7 (Pre-dosing, then 4- and 8- hours post dosing), Day 14 (Pre-dosing, then 4- and 8- hours post dosing)
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Sue Anschutz-Rodgers Eye Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Malik Y. Kahook, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01274403: A Randomized Study With Oral Melphalan + Prednisone (MP) Versus Melphalan, + Prednisone + Thalidomide (MPT) for Newly Diagnosesd Elderly Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Elderly patients
Lead sponsor: Gruppo Italiano Studio Linfomi
Sponsor class: OTHER
First posted: 2011-01-11
Enrollment: 130
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED

Brief summary: The aim of the study is to compare efficacy and toxicity of melphalan and prednisone versus meplhalan, prednisone and Thalidomide in elderly patients with multiple myeloma or patients with multiple myeloma but not eligible for high dose treatment with stem cells support.


Eligibility criteria: Inclusion Criteria:

* newly diagnosed of multiple myeloma.
* Age \> 65 years
* ECOG \<= 3
* Written informed consent given at the time of randomization
* Patients with age \<= 65 but not eligible for high dose treatment with stem cells support

Exclusion Criteria:

* ECOG \> 3
* current neoplasm..
* contraindications to use thalidomide
* peripheral neurophaty

Primary outcomes:
measure: To assess the efficacy
timeFrame: from 8 to 12 months
measure: To assess the toxicity
timeFrame: From 1 to 12 months
Secondary outcomes:
measure: To evaluate the Overall Survival (OS) in the 2 arms of treatment
timeFrame: From 1 to 60 months
measure: To evaluate the Duration of Remission (DR) in the 2 arms of treatment
timeFrame: From 8 to 60 months
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Gruppo Italiano Studio Linfoma
Study officials:
References:
Clinical trial NCT01080703: To Determine if a Lower Extremity Strengthening Program Improve Quadriceps Muscle Strength
Official title: Does The Lower Extremity Resistance Program Improve Quadriceps Strength, Endurance, And Quality Life In Pre-Lung Transplant Patients?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease
Keywords: Lung Transplant
Quadriceps Strength
Quality of Life
Patients with pulmonary disease awaiting lung transplant.
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2010-03-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 determine if a lower extremity strengthening program as part of pulmonary rehabilitation will improve quadriceps muscle strength, endurance and functional status as well as overall quality of life.

Hypothesis:

1. Lower extremity resistance training as part of a pulmonary rehabilitation program will improve quadriceps strength, endurance and functional capacity.
2. Lower extremity resistance training as part of a pulmonary rehabilitation program will improve quality of life in patients awaiting lung transplant.

Detailed description: Objectives:

1. To determine if a lower extremity strengthening program as part of pulmonary rehabilitation is effective at increasing quadriceps strength when measured with a hand held dynamometer.
2. To determine the effectiveness of a lower extremity strengthening program as part of pulmonary rehabilitation for improving endurance and functional capacity as measured by the six minute walk test.
3. To determine if the lower extremity strengthening program as part of pulmonary rehabilitation improves overall quality of life as measured by the St. George's Respiratory Questionnaire.
4. To provide a basic framework for a larger randomized control study evaluating if a lower extremity strengthening program as part of a pulmonary rehabilitation program is more effective than a pulmonary rehabilitation program alone at improving quadriceps strength, endurance, and functional level.

Eligibility criteria: Inclusion Criteria:

* Patients preparing for lung transplant
* Diagnoses included are: Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis, Sarcoidosis, Cystic Fibrosis, or Bronchiectasis

Exclusion Criteria:

* Primary Pulmonary Hypertension
* Multi-organ transplant patients
* Re-transplant patients
* Patients requiring intubation greater than or equal to 7 days prior to transplant
* Any orthopedic condition which will prevent from participation in a lower extremity strengthening program

Primary outcomes:
measure: Quadriceps Strength
timeFrame: 10 weeks
Secondary outcomes:
measure: Quality of Life Survey
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Edward R Garrity, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04670003: Spread Analysis of COVID-19 Outbreak in France by Self-assessment Web-application
Official title: Spread Analysis of COVID-19 Outbreak in France by Self-assessment Web-application: an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Weprom
Sponsor class: OTHER
Collaborators: name: Kelindi
First posted: 2020-12-17
Enrollment: 4975
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: All users of the application contaminated with COVID 19 who have not objected to the use of their data

Brief summary: A coronavirus pandemic began on 12/31/2019 with a first Chinese patient. As of 04/04/2020, the epidemic affects more than 190 countries with more than 50 million official contaminations and 1,251,000 deaths. (Univ J Hopkins). This virus causes a pathology ranging from simple flu-like symptoms in 80% of cases to acute respiratory distress syndromes requiring intensive care in 5% of cases and a death rate of 1.4 to 4% of cases.

Viral contamination is airborne and fecal A first epidemic wave crossed France in March / April 2020 then a second in October / November with a source of contamination which began in mid-August 2020. The sources of propagation are not well known (what places, what times, what contacts...? ) In the context of the health crisis linked to the coronavirus, knowledge of the sources of propagation of this 2nd wave is an important issue to guide end of lockdown and second lockdown policies.


Eligibility criteria: Inclusion criteria:

* users of the application
* not having objected to the use of their data

Exclusion criteria:

- user who does not have a complete questionnaire

Primary outcomes:
measure: Description of the methods of contamination of patients
timeFrame: 2 months
Secondary outcomes:
measure: Evaluation in time of the spread of the virus during the 2nd epidemic wave.
timeFrame: 2 months
measure: Evaluation in space of the spread of the virus during the 2nd epidemic wave.
timeFrame: 2 months
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Institut Interrégional de Cancérologie
Study officials:
affiliation: Institut Interrégional de Cancerologie et Kelindi
name: Fabrice DENIS, MD
role: STUDY_DIRECTOR
References:
citation: Denis F, Septans AL, Le Goff F, Jeanneau S, Lescure FX. Analysis of COVID-19 Transmission Sources in France by Self-Assessment Before and After the Partial Lockdown: Observational Study. J Med Internet Res. 2021 May 4;23(5):e26932. doi: 10.2196/26932.
Clinical trial NCT02344303: Study of the Effects of TRV130, at Therapeutic and Supra Therapeutic Doses, on QTc Intervals
Official title: A Single-dose, Open-label, Fixed Sequence, Two Period Cross Over Study to Assess the Tolerability of a Supra Therapeutic Dose of TRV130 Followed by A Single Dose, Randomized, Double Blind, Comparative, Positive and Placebo Controlled, Four Period Cross-over Study of the Effects of TRV130, at Therapeutic and Supra Therapeutic Doses, on the QTc Intervals in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Trevena Inc.
Sponsor class: INDUSTRY
First posted: 2015-01-22
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Assess the electrocardiogram effects of TRV130 relative to placebo at therapeutic and supratherapeutic doses.

Detailed description: * Part A of the study will assess clinical safety data of TRV130
* Part B of the study will assess the effect of single dose TRV130 on QTc

Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 45 inclusive.
* Women must be either a) post-menopausal; b) surgically sterile; c) of child-bearing potential and practicing contraception or remaining sexually inactive.
* Men must be willing to abstain from sperm donation from the time of Screening through the Follow-up Visit and, if sexually active with a woman of child-bearing potential, must be protected by acceptable forms of effective contraception through the Follow-up Visit.

Exclusion Criteria:

* Past or present diseases including, but not limited to, significant medical abnormalities including: psychiatric, neurologic, pulmonary, cardiac, gastrointestinal, genitourinary, renal, metabolic, endocrinologic or autoimmune disorders.
* Has previously participated in another TRV130 clinical study.

Primary outcomes:
measure: Part A - Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Prior to dose through 4 hours
measure: Part B - Change from baseline in QTc
timeFrame: Prior to dose through 24 hours
Secondary outcomes:
measure: Part B - Pharmacodynamics - QTc
timeFrame: Prior to dose through 24 hours
measure: Part B - Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Prior to dose through Follow-Up Visit
measure: Part A & B - Pharmacokinetics - Cmax, tmax, AUC
timeFrame: Prior to dose through 24 hours
Other outcomes:
Locations:
city: Baltimore
country: United States
state: Maryland
Study officials:
affiliation: Trevena Inc.
name: Franck Skobieranda
role: STUDY_DIRECTOR
References:
Clinical trial NCT02564003: Oxycodone Pharmacokinetics in Preterm Infants
Official title: Oxycodone Pharmacokinetics in Preterms, Infants and Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: Admescope Ltd
First posted: 2015-09-30
Enrollment: 79
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children age from 23 gestational weeks to two years

Brief summary: The pharmacokinetics of oxycodone is well characterized in children older than six months of age. However, only one study has been published with children younger than six months, concluding that unexplained inter-individual variability is pronounced in the youngest children. The aim of the current study was to quantify oxycodone pharmacokinetics in children ranging from preterm newborn infants to children up to two years of age.


Eligibility criteria: Inclusion Criteria:

* Infants scheduled for surgery with planned perioperative or postoperative opioid analgesia were screened if the gestational age (GA) was at least 23 weeks and postnatal age (PNA) below 2 years

Exclusion Criteria:

* He/she had allergy or hypersensitivity to oxycodone or other ingredients in the formulations or had received monoamineoxidase, CYP3A (cytochrome P450 3A enzymes) or CYP2D6 (cytochrome P450 2D6 enzyme) inhibitors during the previous month or other reason that was considered to contraindicate participation.

Primary outcomes:
measure: Peak plasma concentration of oxycodone
timeFrame: time zero hours to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: