louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06669533: Use Misoprostol to Optimize Prevention of Cervical Cancer
Official title: Misoprostol to Optimizing Prevention of Cancer of the Cervix: A Double-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancers
Keywords: cervical cancers
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Cameroon Baptist Convention Health Core
First posted: 2024-11-01
Enrollment: 420
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This is a double-blind randomized controlled trial of 420 non-pregnant women undergoing cancer screening by visual inspection with acetic acid (VIA) who have Type 3 transformation zone (TZ) and randomized to receive either Misoprostol or placebo.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Type 3 TZ confirmed on exam prior to randomization
* Age 25 years or older

Exclusion Criteria:

* With Type 1 or 2 TZ prior to randomization
* Currently pregnant
* History of hysterectomy
* Any cancerous lesions
* Active cervicitis

Primary outcomes:
measure: Conversion rate from Type 3 transformation zone (TZ) to Types 1 or 2
timeFrame: Approximately 2-3 hours and approximately 4-6 hours since drug administration
Secondary outcomes:
measure: Comparison of the rate of patients converted from Type 3 TZ to Type 1 or 2 TZ between 2-3 hours and 4-6 hours
timeFrame: Approximately 2-3 hours vs approximately 4-6 hours
Other outcomes:
Locations:
city: Yaoundé
country: Cameroon
facility: Cameroon Baptist Convention Health Core, EtougEbe Baptist Hospital Yaoundé
state: Center Region
Study officials:
affiliation: University of Alabama at Birmingham
name: Warner K Huh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06249633: Inhaled Nitric Oxide for ARDS-related Pulmonary Hypertension
Official title: A Pilot Study of Inhaled Nitric Oxide for ARDS-related Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Acute Respiratory Distress Syndrome
Pulmonary Hypertension
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2024-02-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open-label pilot study of early inhaled nitric oxide (iNO) for patients developing de novo pulmonary hypertension during Acute Respiratory Distress Syndrome (ARDS.) The study aims to determine whether iNO has possible hemodynamic and clinical benefits when given early in the course of ARDS to patients with evidence of elevated pulmonary artery pressure.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ARDS based on the Berlin criteria
* Mechanically ventilated
* Age ≥ 18 years

Exclusion Criteria:

* Primary cardiogenic shock
* History of more than mild pulmonary hypertension preceding ARDS diagnosis
* Presence of pre-existing significant valvular disease
* Presence of pre-existing left ventricular dysfunction or significant hypertrophy
* Consent cannot be obtained from the patient or his/her surrogates
* Refusal of consent
* Opinion of treating physicians that enrolling the patient in the study would be detrimental to his/her outcome

Primary outcomes:
measure: Determining improvement in pulmonary artery pressure in response to iNO
timeFrame: Approximately 4 days
measure: Determining improvement in tricuspid annular plane systolic excursion in response to iNO
timeFrame: Approximately 4 days
measure: Determining improvement in right ventricular fractional area change in response to iNO
timeFrame: Approximately 4 days
Secondary outcomes:
measure: Improvement in urine output in response to iNO
timeFrame: Approximately 4 days
measure: Improvement in serum creatinine in response to iNO
timeFrame: Approximately 4 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Yuri Matusov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04463433: Psychological Intervention for Parent-child Relationship and Couple Relationship Under COVID-19 in China
Official title: Psychological Intervention for Parent-child Relationship and Couple Relationship Under COVID-19 in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parent-child Relationship and Couple Relationship Under COVID-19 in China
Keywords: COVID-19
Parent-child Relationship
Couple Relationship
Lead sponsor: Beijing Normal University
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Under the COVID-19, individuals who were home Quarantine experienced new challenges on their parent-child relationship and couple relationship. The current project aimed to provide psychological interventions for both parents and couples in order to improving their relationship. The online intervention of group intervention and individual intervention are going to be conducted. The relationship between parent-child, couples and emotion regulation will be tested.


Eligibility criteria: Inclusion Criteria:

1. Parents of students in primary and secondary school.
2. Parents must had primary school education or above.

Exclusion Criteria:

1. Parents cannot speak or read Chinese.
2. Parents have severe mental or physical illness.

Primary outcomes:
measure: Parent-child conflict
timeFrame: 2 weeks
measure: Parent-child communication
timeFrame: 2 weeks
measure: Parent-child Relationship
timeFrame: 2 weeks
measure: Couple Relationship Quality
timeFrame: 2 weeks
measure: Marital Stability
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Normal University
state: Beijing
Study officials:
References:
Clinical trial NCT02934633: Parent Training in Child Safety Practices
Official title: Parent Training in Child Safety Practices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Injury
Keywords: injury
child
cars
pedestrians
child safety
interactive
computer
prevention
internet
CD-ROM
Lead sponsor: Oregon Center for Applied Science, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2016-10-17
Enrollment: 414
Sex: ALL
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This project completed an intervention designed to teach parents of children aged 0-2 years of age how to prevent injuries to their child. The intervention consisted of a two DVD package with information on creating a safe home environment and correctly choosing and installing an appropriate car safety seat. The study hypothesis was that parents who used the intervention would score significantly higher on measures of knowledge, motivation, intention and self-efficacy in implementing injury prevention strategies.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Parent whose oldest child is 0-24 months old
* Speak and read English
* Have internet access (online study only)

Exclusion Criteria:

* Parents who do not have legal or physical custody
* Subjects live in a household in which a family member had an overnight stay in the hospital as a result of an injury in the last 2 years

Primary outcomes:
measure: Change in parent motivation to implement injury prevention strategies
timeFrame: 7 day and 30 day post intervention
measure: Change in parent knowledge of injury prevention practices
timeFrame: 7 and 30 day post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Oregon Center for Applied Science
state: Oregon
Study officials:
affiliation: Oregon Center for Applied Science
name: Lynne H Grilley Swartz, MPH, CHES
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05693233: Effect of Soft Robotic Exosuit Assistance in Healthy People
Official title: Effect of Soft Robotic Exosuit Assistance in Healthy People
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Person
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to find out what effect there is on the difference in energy use efficiency and gait analysis when walking while wearing knee and hip assist robots based on flexible power structures for normal people. Energy consumption efficiency will measure the amount of energy metabolism and heart rate during walking for a set period of time, and for gait analysis, kinetic and kinematic data will be analyzed through 3D motion analysis. In addition, after completing the evaluation, we intend to help in future improvement of the product by collecting usability and satisfaction evaluation and improvements through questionnaires.


Eligibility criteria: Inclusion Criteria

* Healthy adults aged 19 years or older with no disabilities in walking in daily life and who have not had back or knee surgery in the past
* Those who have no problem wearing knee and hip assist robots
* A person who understands this research, has a willingness to participate voluntarily, and agrees to participate

Exclusion Criteria

- researcher judges that participation in this research is inappropriate

Primary outcomes:
measure: oxygen consumption measured
timeFrame: Simultaneous measurement of variables while walking on a treadmill_up to 24 weeks
Secondary outcomes:
measure: 3D Motion Capture
timeFrame: Simultaneous measurement of variables while walking on a treadmill_up to 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Deog Young Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05015933: Intrathecal Pump Refills at Home
Official title: Feasibility, Safety and Effectiveness of Intrathecal Pump Refills at Home: a Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrathecal Drug Delivery
Implantable Pump
Telemedicine
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this pilot study is to evaluate the feasibility, safety and effectiveness of intrathecal pump refill procedures at home. It is our hypothesis that a refill at home will be safe, effectiveness and feasible, as is demonstrated in The Netherlands, and preferred by patients.


Eligibility criteria: Inclusion Criteria:

* Patient receives intrathecal drug therapy
* Patient is at least 18 years old
* Native French-or Dutch speaking persons.

Exclusion Criteria:

* Patients \< 18 years old.
* No native Dutch or French speaking persons.

Primary outcomes:
measure: Patient satisfaction
timeFrame: Once, at the moment of the study visit, immediately after the pump refill
measure: Successful pump refill
timeFrame: Once, at the moment of the study visit, immediately after the pump refill
measure: Patient safety
timeFrame: Once, at the moment of the study visit, immediately after the pump refill
measure: Physician safety
timeFrame: Once, at the moment of the study visit, immediately after the pump refill
Secondary outcomes:
measure: Environmental safety
timeFrame: Once, at the moment of the study visit, immediately after the pump refill
measure: Clean, sterile procedure
timeFrame: Once, at the moment of the study visit, immediately after the pump refill
measure: An objective confirmation of correct injection in the pump by ultrasound.
timeFrame: Once, at the moment of the study visit, immediately after the pump refill
measure: Adverse events
timeFrame: Once, at the moment of the study visit, immediately after the pump refill
measure: Patient feasibility
timeFrame: Once, at the moment of the study visit, immediately after the pump refill
measure: Quality of teleconsultant connection by teleconsultant
timeFrame: Once, at the moment of the study visit, immediately after the pump refill
measure: Time burden for teleconsultant
timeFrame: Once, at the moment of the study visit, immediately after the pump refill
measure: Physician feasibility
timeFrame: Once, at the moment of the study visit, immediately after the pump refill
measure: Quality of teleconsultant connection by physician
timeFrame: Once, at the moment of the study visit, immediately after the pump refill
measure: Time burden for physician
timeFrame: Once, at the moment of the study visit, immediately after the pump refill
measure: Patient preference
timeFrame: Once, at the moment of the study visit, immediately after the pump refill
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
Study officials:
References:
Clinical trial NCT05634733: Change in MAPSE During Treatment of Sepsis
Official title: Evaluation of Mitral Annulus Systolic Plane Excursion (MAPSE) in Emergency Department Patients With Sepsis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Keywords: POCUS
Emergency Department
echocardiography
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 50
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: adult emergency department patients who present with sepsis

Brief summary: Patients with bloodstream infections (sepsis) have been found in prior studies to have infection-related heart dysfunction, even if they did not have preexisting heart problems. Factors related to the infection may cause the heart to not pump as well as it should, causing critical illness in the form of low blood pressure (shock) and heart failure. Ultrasound is frequently used in the emergency department to evaluate why a patient might have low blood pressure. Part of that evaluation may include obtaining ultrasound images and making measurements about how well or poorly the heart is pumping. The investigators will evaluate a certain measurement that relates to cardiac function, determine how it changes in patients before and after they are treated for septic shock. This will involve placing an ultrasound probe on the patient's chest, measuring the upward and downward movement of the mitral valve, the mitral annulus systolic plane excursion (MAPSE), and comparing the measurements before and after treatment is started. The investigators are attempting to determine if this measurement improves before and after treatment.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Sepsis or Septic Shock

Exclusion Criteria:

* Age equal to or less than 17
* patient in the emergency department
* Unable to perform POCUS exam due to medical necessity
* Patients without sepsis
* unable to obtain consent or have a legal representative consent

Primary outcomes:
measure: Change in MAPSE measurement
timeFrame: 1 hour after treatment initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
References:
Clinical trial NCT00519233: AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer
Official title: A Phase I Investigation of the Intravenous Administration of AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: HRPC
Advanced hormone refractory prostate cancer
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Agensys, Inc.
First posted: 2007-08-22
Enrollment: 13
Sex: MALE
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: The present study will investigate the safety, tolerability and spectrum of side effects of AGS-1C4D4. As such, this study will characterize the dose limiting toxicities (DLT) and potentially the maximum tolerated dose (MTD) of AGS-1C4D4 in patients with advanced HRPC.

Detailed description: Cohorts of 1-6 patients will be administered AGS-1C404 in sequentially rising dose levels. Dose escalation will continue until the MTD of AGS-1C4D4 is established or the maximum planned dose is reached.

Eligibility criteria: Inclusion Criteria:

* Patient has hormone-refractory metastatic prostate cancer

Exclusion Criteria:

* Patient has had chemotherapy, radiotherapy, or biological therapy within the past 4 weeks or has not recovered from side effects
* Patient is currently participating or has participated in an investigational study within the past 30 days
* Patient has illness or circumstance that could limit compliance with the study requirements
* Patient uses illicit drugs or had a recent history of drug or alcohol abuse within the last year
* Patient has Hepatitis B or C

Primary outcomes:
measure: Safety, tolerability and side effects of AGS-1C4D4 in adult patients with advanced HRPC.
timeFrame: 3 Months
Secondary outcomes:
measure: The pharmacokinetic profile of AGS-1C4D4 in adult patients with advanced HRPC.
timeFrame: 3 Months
Other outcomes:
Locations:
city: Baltimore
country: United States
state: Maryland
city: New York
country: United States
state: New York
Study officials:
affiliation: Agensys, Inc.
name: Central Contact
role: STUDY_DIRECTOR
References:
citation: Antonarakis ES, Carducci MA, Eisenberger MA, Denmeade SR, Slovin SF, Jelaca-Maxwell K, Vincent ME, Scher HI, Morris MJ. Phase I rapid dose-escalation study of AGS-1C4D4, a human anti-PSCA (prostate stem cell antigen) monoclonal antibody, in patients with castration-resistant prostate cancer: a PCCTC trial. Cancer Chemother Pharmacol. 2012 Mar;69(3):763-71. doi: 10.1007/s00280-011-1759-9. Epub 2011 Oct 22.
Clinical trial NCT05487833: Insulin and Standard Management in Hypertriglyceridemic Acute Pancreatitis
Official title: Comparison of Insulin and Standard Management in Hypertriglyceridemic Acute Pancreatitis in Patients Without Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertriglyceridemia
Acute Pancreatitis
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of infusion containing insulin and infusion without insulin on reduction of triglycerides in acute hypertriglyceridemic pancreatitis


Eligibility criteria: Inclusion Criteria:

* acute pancreatitis
* triglycerides \> 15 mmol/l

Exclusion Criteria:

* diabetes on peroral therapy or insulin
* blood glucose \> 11 mmol/l
* pregnancy

Primary outcomes:
measure: %triglyceride reduction
timeFrame: after 18 hours of treatment
Secondary outcomes:
measure: incidence of hypoglycemia
timeFrame: during treatment with insulin, up to day 5
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04651933: A Training Set for the HRD Model in EOC
Official title: A Training Set for the Homologous Recombination Deficiency Scoring Model With Loss of Heterozygosity Status in Epithelial Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epithelial Ovarian Cancer
BRCA Mutation
Loss of Heterozygosity
Prognosis
Platinum Resistance
Homologous Recombination Deficiency
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with known BRCA1/2 mutation status and resistance to platinum-based chemotherapy

Brief summary: A homologous recombination deficiency (HRD) scoring model based on loss of heterozygosity (LOH) is little explored in epithelial ovarian cancer (EOC) patients. This study would recruit 200 Chinese EOC patients with known BRCA1/2 mutation status and resistance to platinum-based chemotherapy. A LOH-HRD model is to be constructed based on the genetic testing in these patients. The mutated genes, HRD score model and their relationship with the prognosis, would provide a full description of for the Chinese EOC patients, and a potential explanation of platinum-resistance in such population.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Pathological confirmation of epithelial ovarian cancer
* With available tumor tissues
* Given consents to participate the study

Exclusion Criteria:

• Not meeting all of the inclusion criteria

Primary outcomes:
measure: Homologous recombination deficiency (HRD) score
timeFrame: Two years
Secondary outcomes:
measure: Progression-free survival
timeFrame: Five years
measure: Overall survival
timeFrame: Five years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: