louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01921712: A Safety, Pharmacokinetic and Pharmacodynamic Study of PUR0200 in COPD Patients
Official title: A Phase I, 2-Part, Single-dose, Placebo and Active-Controlled, Dose-ranging, Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Chronic Obstructive Pulmonary Disease
Lead sponsor: Pulmatrix Inc.
Sponsor class: INDUSTRY
Collaborators: name: Quotient Clinical
First posted: 2013-08-13
Enrollment: 38
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of PUR0200. In addition, the study will look at the blood levels of different doses of PUR0200 and their affect on lung function in COPD patients.

Detailed description: This is a multi-center, 2-part, pharmacokinetic (PK), pharmacodynamic (PD) effect, safety and tolerability study of single doses of PUR0200.

Eligibility criteria: Key Inclusion Criteria:

* A clinical diagnosis of moderate to severe COPD according to the following criteria:

  * Current or ex-smokers with at least 10 pack-year smoking history
  * Post-bronchodilator FEV1 \>/= 35% and \</= 80% of predicted normal value
  * Post-bronchodilator FEV1/FVC (forced vital capacity) ratio \<0.70
  * Post-bronchodilator improvement in FEV1 \>/= 100 mL

Key Exclusion Criteria:

* Current evidence or recent history of clinically significant or unstable disease (other than COPD)
* Current diagnosis of asthma
* Presence of history of clinically significant allergy requiring treatment
* COPD exacerbation within 6 weeks
* Use of daily oxygen therapy \> 10 hours
* Thoracotomy with pulmonary resection
* Use of systemic steroids within 3 months
* Lower respiratory tract infection within 30 days
* Upper respiratory tract infection within 30 days requiring treatment with antibiotics
* History of tuberculosis, bronchiectasis, or other non-specific pulmonary disease
* Prolonged corrected QT (QTc) interval \>450 msec males and \>470 msec females, or history of long QT syndrome

Primary outcomes:
measure: Peak plasma concentration (Cmax) of PUR0200
timeFrame: 0 to 24 hours
measure: Time to reach peak plasma (Tmax) concentration of PUR0200
timeFrame: 0 to 24 hours
measure: Area under the plasma concentration versus time (AUC) of PUR0200
timeFrame: 0 to 24 hours
measure: Trough forced expiratory volume in 1 second (FEV1)
timeFrame: 24 hours
measure: Trough FEV1 difference from baseline
timeFrame: 24 hours
measure: Number of participants with adverse events
timeFrame: up to 14 days post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Medicines Evaluation Unit
city: Nottingham
country: United Kingdom
facility: Quotient Clinical
Study officials:
affiliation: Pulmatrix Inc.
name: David Hava, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05153512: ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)
Official title: ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometriosis
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
First posted: 2021-12-10
Enrollment: 350
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women between 12 and 20 years-old and suffering from dysmenorrhea

Brief summary: To date, no MRI study has been published describing the prevalence of endometriosis in adolescent girls, not even in those with significant dysmenorrhea and therefore more particularly at risk. Likewise, there are no precise data on the type of superficial or early-onset deep endometriosis that appears in adolescence. The collection of these data would allow an earlier diagnosis, because it is better documented, of endometriosis. The lesions would then be treated earlier, avoiding their development and the problems of infertility related to this pathology. The aim of this sudy is to assess the prevalence of endometriosis and its phenotypic representation in the study population consulting for dysmenorrhea with suspected endometriosis.


Eligibility criteria: Inclusion Criteria:

* Patient aged between 12 and 20 years old.
* After menarche.
* Requiring pelvic MRI for exploration of dysmenorrhea (after or not ultrasound), in the case of patients with suspected endometriosis, or for any other reason (cyst, tumor, non-obstructive urogenital malformations), in the case of patients without symptoms clinic associated with endometriosis.
* Patient affiliated or beneficiary of a social security scheme.
* Patient and her legal representative, if applicable, having been informed and not opposing this research.

Exclusion Criteria:

* Patient whose pelvic MRI is performed as part of an exploration of obstructive uterine malformations.
* Patient claustrophobic, making it impossible to perform an MRI.
* Contraindication to MRI: pacemaker, ferromagnetic object incompatible with MRI.
* Pregnant, breastfeeding or parturient woman.
* Protected patient: Major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision; Hospitalized without consent.

Primary outcomes:
measure: Number of patient with endometriosis detected on MRI
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: BLOMET clinic
state: IDF
Study officials:
References:
Clinical trial NCT04802512: Turkish Version of Telehealth Usability Questionnaire (TUQ)
Official title: Investigation of the Turkish Validity and Reliability of the Telehealth Usability Questionnaire (TUQ)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Care Acceptor
Health Knowledge, Attitudes, Practice
Patient Participation
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 170
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Turkish validity and reliability of the scale, which was created to evaluate the usability of the telehealth service for service users (patients) and providers (health professional), will be investigated.

Brief summary: The Telehealth Usability Questionnaire (TUQ) was developed to evaluate the usability of telehealth applications and services. The Turkish validity and reliability study of the scale, originally in English, has not been conducted before.

The aim of this study is to develop the Turkish version of the Telehealth Usability Questionnaire (TUQ), which is a new stability tool, and to report its reliability assessment.

Detailed description: The Telehealth Usability Questionnaire (TUQ) turkish version will be asked by using google forms to participants whom use telehealth.

Eligibility criteria: Inclusion Criteria:

Participants will undergo screening to confirm eligibility, completion of initial screening form, and MMSE evaluation. Study subjects were enrolled with MMSE scores between 29-30, inclusive (healthy/control), 25-28, inclusive (mild cognitive impairment), and 10-24 (dementia).

-

Exclusion Criteria:

* Unable to complete computerized and standard pencil-and-paper based assessments

Primary outcomes:
measure: Reliability and Validity of TUQ by Correlation Analysis.
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Hatay
country: Turkey
facility: Hatay Mustafa Kemal University
state: Merkez
city: Hatay
country: Turkey
facility: Online
Study officials:
affiliation: Mustafa Kemal University
name: Irem Huzmeli, Phd
role: STUDY_DIRECTOR
affiliation: Mustafa Kemal University
name: Esra Dogru Huzmeli, Assoc Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mustafa Kemal University
name: Mehmet Karadağ, Asist. Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT04242212: Study of Clinic-based vs. Self-use of a Misoprostol-only Regimen for Induced Abortion
Official title: A Prospective, Comparative Study of Clinical Outcomes Following Clinic-based Versus Self-use of Medication Abortion Using a Misoprostol-only Regimen
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Induced Abortion
First Trimester Abortion
Keywords: Medication abortion
Misoprostol
Lead sponsor: Ipas
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 4000
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nigerian women, age 15-49, living in the study geography, who are pregnant and seeking a misoprostol-only regimen for medication abortion, either from a patent medicine vendor or a healthcare clinic/facility.

Brief summary: The goal of the study is to determine whether important clinical outcomes differ among women who access a misoprostol-only medication abortion regimen from a patent medicine vendor when compared with those who access it from a clinic.

Detailed description: Medication abortion with a misoprostol-only regimen within the first 10 weeks of pregnancy is safe and effective. Investigators aim to assess whether self-use of early (\<9 weeks) medication abortion using a misoprostol-only regimen results in non-inferior rates of clinical outcomes when compared with clinic-based provision of medication abortion.

The investigators will prospectively recruit women who obtain misoprostol from patent medicine vendors and clinics. Follow-up will occur by telephone during three phone calls within 45 days of the first dose of misoprostol.

Eligibility criteria: Inclusion Criteria:

* Purchased a misoprostol-only abortion regimen at a PMV or from a clinic
* Be at least 15 years of age
* Have a known LMP of less than 9 weeks
* No contraindications to medical abortion
* Willing and able to give informed consent
* Have a mobile phone of which they are the independent user or be willing to be followed-up in person
* Willing to be contacted with questions about her abortion by telephone at 1-3, 10-29 and 30-45 days following initial contact.

Exclusion Criteria:

* Contraindications to misoprostol
* Age \<15 or \>49

Primary outcomes:
measure: Need for additional treatment to complete abortion
timeFrame: Final assessment at 45 days following misoprostol
Secondary outcomes:
measure: Serious complications/ morbidity
timeFrame: Final assessment at 45 days following misoprostol
Other outcomes:
measure: Uptake of postabortion contraception
timeFrame: Final assessment at 45 days following misoprostol
Locations:
city: Awka
country: Nigeria
facility: Multiple facilities
state: Anambra
city: Abeokuta
country: Nigeria
facility: Multiple facilities
state: Ogun
city: Ibadan
country: Nigeria
facility: Multiple facilities
state: Oyo
Study officials:
References:
Clinical trial NCT04400812: Attitude and Perception Towards COVID-19 Pandemic
Official title: Attitude and Perception of General Population in Sharkia Governerate Towards COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-05-26
Enrollment: 5000
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population within age range (16-70) and both sexes living in Sharkia Governerate, Egypt and accept to participate

Brief summary: Assess response and attitude of general population living in Sharkia Governerate, Egypt as regard COVID-19 pandemic through arabic questionnaire.


Eligibility criteria: Inclusion Criteria:

* General population within age range (16-70) and both sexes living in Sharkia Governerate, Egypt and accept to participate

Exclusion Criteria:

* below 16 or above 70 years
* refuse to participate
* duplicate answers
* incomplete answers

Primary outcomes:
measure: Knowledge about COVID-19 by questionnaire
timeFrame: 30 days after enrollment
measure: Perception about COVID-19 by questionnaire
timeFrame: 30 days after enrollment
measure: Attitude towards COVID-19 by questionnaire
timeFrame: 30 days after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
state: Sharkia
Study officials:
References:
Clinical trial NCT00330512: Maternal Hypotension During Cesarean Section and Short Term Neonatal Outcome.
Official title: Maternal Hypotension During Elective Cesarean Section and Short Term Neonatal Outcome.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Elective Cesarean Section
Maternal Hypotention
Keywords: regional anestesia
cesarean section
hypotention
newborn
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-05-26
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: About 20-25% of deliveries are by cesarean section. Most are elective with use of regional anesthesia (spinal/epidural). Drop of blood pressure after regional anesthesia is common. It have the risk of reduction of blood flow to the placenta and the fetus.

No studies had followed the newborns their first days of live,of mothers who developed hypotension in durins CS.

Detailed description: A reterospective study of all full term babies, born in elective cesarean section with use of regional anesthesia. Two groups will be define rgarding maternal hypotention following regional anesthesia - maternal hypotention (study group) or normal maternal BP. The definition of Maternal hypotension: decrease in 10% or more in mean BP in compared to first BP taken at admition.

Data will colect from mothers and neonates records as well as operation data. Maternal data: gravida, parity, diseases, medications, demographics, and all data regarding the operation (blood pressures, Heart rates, saturation, treatment given etc.).

Infant data: gestational age, birth weight, sex, Apgar, cord pH, clinical manifestations, medications, time of hospitalization.

Eligibility criteria: Inclusion Criteria:

* fullterm infants, born by elective cesarean section using regional anasthesia.

Exclusion Criteria:

* preterms, urgent CS, CS using general anasthesia, Multiple pregnancy, Congenital malformations.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sheba Medical Center
name: Ayala Maayan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01372046: Implementing & Testing Assessment and Referral Technologies in Juvenile Justice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Skill Development of Staff
Use of Standardized Assessment Tools
Keywords: technology transfer
skill development
organizational change
Lead sponsor: George Mason University
Sponsor class: OTHER
Collaborators: name: University of Maryland
name: National Institute on Drug Abuse (NIDA)
First posted: 2011-06-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 1. Assess the impacts of implementing a juvenile assessment, referral, placement, and treatment planning (J-ARPP) protocol, and of different strategies for transferring J-ARPP technology, on service utilization of youth entering the juvenile justice system.
2. Assess the impacts of implementing J-ARPP, and of different strategies for transferring J-ARPP technology, on measures of organizational readiness and motivation, and staff attitudes about assessment and service.
3. Assess the impacts of implementing J-ARPP, and of different strategies for transferring J-ARPP technology, on measures of systems integration.
4. Assess fidelity to the J-ARPP protocol and the relationship between fidelity to the J-ARPP protocol and service utilization of youth entering the juvenile justice system.


Eligibility criteria: Inclusion Criteria:

* all offices

Primary outcomes:
measure: Service utilization
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: State of MD, Juvenile justice offices
state: Maryland
Study officials:
affiliation: George Mason University
name: Faye Taxman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland
name: Doug Young, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01747746: Anticoagulation With Rivaroxaban in Cardioversion -The ARC Study
Official title: Anticoagulation With Rivaroxaban in Post Cardioversion Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Stroke
Thrombo-embolism
Bleeding
Keywords: Rivaroxaban
Warfarin
Anticoagulation
Stroke
Thrombo-embolism
Bleeding
Atrial Fibrillation
Cardioversion
Lead sponsor: Cook County Health
Sponsor class: OTHER_GOV
Collaborators: name: Cook County Hospital
First posted: 2012-12-12
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine that a new drug called "Rivaroxaban®" is effective in preventing patients from forming clots after their heart rhythm has been reset by the cardiologist with an electrical device.

Detailed description: Patient who are electrically cardioverted require 1 month of anticoagulation (blood thinner). Rivaroxaban a Xa-inhibitor has been shown to be non-inferior to Warfarin (Vit K antagonist) the current standard of care in many treatment areas. Rivaroxaban will be compared to Warfarin historical control group studying the safety and efficacy in electrically cardioverted patients.

Eligibility criteria: Inclusion Criteria:

* Patients with non-valvular atrial fibrillation requiring electrical cardioversion o Atrial fibrillation of unknown duration

Exclusion Criteria:

* Patients requiring extended anticoagulation after cardioversion due to concomitant risk factors as defined by CHADS2 score ≥ 1
* Significant renal dysfunction (CrCl \<15mL/min)
* Significant hepatic dysfunction (Childs-Pugh Class B or C)
* History of coagulopathy
* Active bleeding
* Hypersensitivity to Rivaroxaban
* Concomitant use of anticoagulants
* Concomitant use of potent CYP3A4/P-gp inhibitors or inducers
* Interventions requiring interruption of therapy
* Pregnancy
* Age \<18 y/o
* History of GI Bleed

Primary outcomes:
measure: Thrombosis
timeFrame: 30 days
Secondary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Hospitalizations
timeFrame: 30 days
measure: Bleeding
timeFrame: 30 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Cook County Hospital
state: Illinois
Study officials:
affiliation: Cook County Hospital
name: Pete Antonopoulos, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cook County Hospital
name: Asinul Ansari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01069146: Mild Therapeutic Hypothermia During Severe Sepsis
Official title: Mild Therapeutic Hypothermia During Severe Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Keywords: sepsis,
septic shock,
therapeutic hypothermia
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2010-02-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives: to evaluate the feasibility, the safety and the effects on physiological parameters of mild therapeutic hypothermia during septic shock.

Design: a randomized, controlled, pilot physiological study. Setting: a 15-beds university-affiliated intensive care unit of a teaching Hospital.

Patients: twenty ventilated and sedated adults patients with septic shock Intervention: Mild therapeutic hypothermia between 32 and 34°C during 36 consecutive hours using an external water cooling blanket.


Eligibility criteria: Inclusion Criteria:

* age \> 18-yrs,
* sedation and mechanical ventilation for at least 48-hrs,
* the diagnosis of septic shock according to standard guidelines.

Exclusion Criteria:

* bradycardia \< 50 bpm, or any severe ventricular rhythm disturbances,
* pregnancy,
* need for emergent surgery or any other complementary exam involving patient transport within the sixth hours following inclusion,
* decision to withdraw or withhold life support,
* predictable death within six hours.

Primary outcomes:
measure: feasibility of hypothermia induction during sepsis
timeFrame: 48 hours
Secondary outcomes:
measure: hemodynamic parameters evolution
timeFrame: 48 hours
Other outcomes:
Locations:
city: Brest
country: France
facility: Réanimation Médicale, CHU de la Cavale Blanche
Study officials:
References:
Clinical trial NCT00000346: Cognitive Correlates of Substance Abuse - 11
Official title: Cognitive Correlates of Substance Abuse, Part 1
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Amphetamine-Related Disorders
Keywords: amphetamine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 1999-09-21
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize the cognitive performance of methamphetamine abusers by comparing them with cocaine abusers and normal controls.


Eligibility criteria: Inclusion Criteria:

M/F . Meet DSM-IV criteria for cocaine or methamphetamine dependence. Agree to conditions of the study and sign informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Friends Research Institute
state: California
Study officials:
affiliation: Friends Research Institute, Inc.
name: Walter Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
References: