louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03676855: Comparison Between Bladder Dissection Before and After Uterine Incision in Cesarean Section for Morbidly Adherent Placenta
Official title: Comparison Between Bladder Dissection Before and After Uterine Incision in Cesarean Section for Morbidly Adherent Placenta
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Morbidly Adherent Placenta
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison between bladder dissection at the beginning of cesarean section For morbidly adherent placenta and between delaying dissection until planning for cesarean hysterectomy


Eligibility criteria: Inclusion Criteria:

1. Women with BMI at or under 35 Kg/m2.
2. Women having previous two cesarean section or more.
3. Women with gestational age more than 32 weeks with viable fetus.
4. Women with any degree of placenta previa .
5. Patient with morbidly adherent placenta on cesarean scar only.

Exclusion Criteria:

1. Patient who are haemodynamically unstable before skin incision.
2. Patient with clinically evident intraamniotic infection.
3. Patient with previous history of bladder injury .

Primary outcomes:
measure: Operative time
timeFrame: icluding all cs over the period of one year
measure: Blood loss
timeFrame: icluding all cs over the period of one year
measure: - Incidence of urological
timeFrame: during cs and post operative delayed complication icluding all cs over the period of one year
Secondary outcomes:
measure: Neonatal APGAR score
timeFrame: after delivery of the baby during the 1st 15 minutes
measure: Time taken to create bladder flap
timeFrame: from the start of bladder dissection icluding all cs over the period of one year
measure: 3 months post operative filling cystometry
timeFrame: 3 months post operative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
References:
Clinical trial NCT00380055: Reducing Cancer Disparities for American Indians in the Rural Intermountain West
Official title: Reducing Cancer Disparities for American Indians in the Rural Intermountain West
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Colorectal Cancer
Breast Cancer
Cervical Cancer
Lung Cancer
Keywords: Cancer Screening
Navigators
Community Outreach
Behavioral Change
Access
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Sletten Cancer Institute
name: Centers for Medicare and Medicaid Services
First posted: 2006-09-25
Enrollment: 1800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this demonstration is to evaluate the effectiveness of using community outreach workers (navigators) to help American Indians living in rural areas overcome barriers to appropriate cancer screening, diagnosis, and treatment.

Detailed description: Even for American Indians who have coverage with Medicare, disparities have been noted in the provision of cancer screening, diagnosis, and treatment. These disparities have been related to a variety of health-system, health-financing, geographic, and cultural barriers. We hypothesize that the use of lay community outreach workers will be an effective means of identifying and overcoming these barriers in order to improve the proportion of Medicare-eligible American Indians who receive recommended screening and diagnosis for prostate, breast, colon, and cervical cancer, and the proportion of individuals receiving appropriate treatment for prostate, breast, colon, cervical, and lung cancer. Community clusters randomized to this form of cancer navigation will be compared with community clusters randomized to receive educational outreach only.

Eligibility criteria: Inclusion Criteria:

* Enrolled in Medicare Part B
* Self-reported American Indian

Exclusion Criteria:

* Have cancer other than study cancer
* Medicare Part C enrolled

Primary outcomes:
measure: Proportion of individuals receiving recommended screening for prostate, breast, colorectal, and cervical cancer.
timeFrame: four years
Secondary outcomes:
measure: Proportion of individuals receiving recommended diagnostic follow-up for prostate, breast, colorectal, and cervical cancer.
timeFrame: four years
measure: Proportion of individuals receiving recommended treatment for prostate, breast, colorectal, cervical, and lung cancer.
timeFrame: four years
measure: Cost-effectiveness of using community navigators to improve cancer care among rural Native Americans.
timeFrame: 10 years
Other outcomes:
Locations:
city: Great Falls
country: United States
facility: Sletten Cancer Institute
state: Montana
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: Huntsman Cancer Institute
name: Randall W. Burt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01553955: Efficacy of Training in Manual Preparation of Platelet Rich Plasma
Official title: Efficacy of Training in Preparation of Platelet Rich Plasma Using a Standard Centrifuge and Manual Pipetting Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Platelet Rich Plasma Production
Keywords: PRP,
Platelet
Manual
Lead sponsor: Peterson, Noel, N.D.
Sponsor class: INDIV
First posted: 2012-03-14
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a device study in some respects, in that specialized centrifuges are commonly used to make platelet rich plasma, and we are studying the use of standard laboratory equipment to do so. However, it is primarily interventional in that we will evaluate the percentage success of trainees in the concentration of viable platelets to more than 4X baseline using a generic speed centrifuge and a single spin method.


Eligibility criteria: Inclusion Criteria:

* English speaking medical practitioners(N.D., D.O. or M.D.)or their office staff

Exclusion Criteria:

* History of difficult blood draws
* Platelet count \< 150,000

  * Hb \< 37%
* History of blood disorder
* History of altered platelet function
* History of chemotherapy or radiation therapy.

Primary outcomes:
measure: Platelet Concentration Ability After 8 Hours of Training.
timeFrame: 8 Hours After Onset of Training
Secondary outcomes:
measure: Retention of Platelet Concentration Ability At One Month.
timeFrame: Minimum 30 days after training day.
Other outcomes:
Locations:
city: Lake Oswego
country: United States
facility: Noel Peterson, N.D.
state: Oregon
Study officials:
affiliation: Noel Peterson, N.D.
name: Noel Peterson, N.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: K. Dean Reeves, M.D., P.A.
name: K. Dean Reeves, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05483114: Comparison of Precision in Brackets Position in Two Indirect Bonding Materials
Official title: Comparison of the Precision in the Position of Brackets With Two Indirect Bonding Materials: Polyvinylsiloxane and Thermal Glue. Split-mouth Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthodontic Appliance Complication
Malocclusion
Keywords: indirect bonding
Lead sponsor: Fundación Universitaria CIEO
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Split-mouth randomized clinical trial study, with 15 participants.
Primary purpose: TREATMENT

Brief summary: Objective: To compare the cementation precision of self-ligating brackets between two indirect bonding materials: polyvinylsiloxane and thermal glue.

Methods: Split-mouth randomized clinical trial study, with 15 participants. The study will be divided into two groups, Group 1: Polyvinylsiloxane and Group 2: Thermal glue.

Detailed description: Patients from the self-ligation clinic who meet the inclusion criteria will be invited to participate and sign the informed consent. For the cementation of the brackets in each patient, the upper arch (right and left) will be divided from the second premolar on the right side to the second premolar on the left side, randomly assigned, to be cemented with a polyvinylsiloxane transfer tray and the other with thermal glue (materials selected for the study).

Eligibility criteria: Inclusion Criteria:

* Permanent dentition with the presence of teeth 15-25 with
* Crowding in the upper arch according to Little's irregularity index,
* Teeth with healthy enamel (without hypoplasias, fluorosis, amelogenesis imperfecta),
* Fully erupted teeth

Exclusion Criteria:

* Absence of teeth selected for the study or that required premolar extractions before starting alignment and leveling
* Patients with rehabilitation such as crowns, veneers, fractured dentition, atypical morphology
* Teeth whose bracket loosens at the time of the procedure due to failure of the union
* Poor oral hygiene
* Patients with any significant displacement of the tooth that could prevent seating of the transfer tray
* Study models with bubbles.

Primary outcomes:
measure: Linear mesio-distal position
timeFrame: 2 weeks
measure: Linear occlusal-gingival position
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fundacion universitaria CIEO - Unicieo
name: Maria M Zamora, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03136614: Prognostic Value of the Arteriograph in the Surgical Theatre and at the Intensive Care Unit
Official title: Prognostic Value of the Arteriograph in the Surgical Theatre and at the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anaesthesia
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: To investigate how pulse wave velocity, aortic augmentation index and the arterial pulse wave given by the Arteriograph contributes to preoperative assesment, intraoperative and intensive care monitoring.


Eligibility criteria: Inclusion Criteria:

For the "preoperative" arm:

* Signed informed consent form
* Arterial catheter for hemodynamic monitoring

For the "intraoperative" arm:

* Signed informed consent form
* Arterial catheter for hemodynamic monitoring
* The operation will presumably last for more than 2 hours

For the "intensive care unit" arm:

* Signed informed consent form
* PiCCO monitor for hemodynamic monitoring

Exclusion Criteria:

For the "preoperative" arm:

* Pregnancy
* Subject belongs to a vulnerable group (ISO 14155:2011) e.g.: study member, medical student

For the "intraoperative" arm:

* Pregnancy
* Subject belongs to a vulnerable group (ISO 14155:2011) e.g.: study member, medical student
* Measuring blood pressure on both arms is not possible
* Insertion of an arterial catheter is not necessary or contraindicated
* Insertion of a central venous catheter is not necessary or contraindicated

For the "intensive care unit" arm:

* Pregnancy
* Subject belongs to a vulnerable group (ISO 14155:2011) e.g.: study member, medical student

Primary outcomes:
measure: Number and degree of hypotensive episodes predicted by preoperative values of pulse wave velocity.
timeFrame: One year
measure: Correlation between systemic vascular resistance and aortic augmentation index
timeFrame: One year
measure: Identity of cardiac output given by the PiCCO monitor and cardiac output given by the Arteriograph
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: Department of Anaesthesiology and Intensive Therapy
state: Csongrád
Study officials:
References:
Clinical trial NCT02558114: Ribavirin for Severe Acute and Chronic Hepatitis E Virus Infection.
Official title: Randomized Study of Two Treatment Strategies With Ribavirin for Chronic Hepatitis E and Severe Acute Forms
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hepatitis E
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2015-09-23
Enrollment: 5
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: The purpose of the study is to compare the efficacy, safety and recurrence rate of two therapeutic strategies with ribavirin in patients with chronic hepatitis E and severe acute hepatitis E: fixed duration of treatment for 12 weeks vs variable duration depending on the viremia within 4 weeks of the start of treatment (12 vs 24 weeks).

The purpose of the study is also improve the safety of treatment with Ribavirin by optimizing dose adjusted to renal function, plasma levels of drug and hemoglobin.


Eligibility criteria: Inclusion Criteria:

* Age equal or greater than 18 years.
* To comply with any of the following diagnoses:
* chronic Hepatitis E: HEV RNA detectable in patients with elevated transaminase levels for at least 6 months and / or HEV RNA detectable in two separated determinations by an interval of six months .
* severe acute Hepatitis E: alanine aminotransferase (ALT) levels greater than 10 times the normal limit, with HEV RNA positive, and signs of acute liver injury (International normalized ratio(INR\> 1.5)); or with extrahepatic manifestations or liver failure in patients with previous liver disease.
* Signed informed consent

Exclusion Criteria:

* Terminal illness with a expected life expectancy of less than 6 months
* Patients with contraindications for treatment with Ribavirin:
* pregnancy or lactation.
* Severe hepatic impairment or decompensated cirrhosis.
* hemoglobinopathies (thalassemia, sickle cell anemia).
* history of severe pre-existing cardiac disease, including unstable heart disease.

Primary outcomes:
measure: Sustained virological response measured by HEV RNA
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari vall d'Hebron
Study officials:
References:
Clinical trial NCT05955014: Data Collection Protocol for Patients With Von Hippel Lindau Disease
Official title: Data Collection Protocol for Patients With Von Hippel Lindau Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Von Hippel Lindau Disease
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: M D Anderson Cancer Center

Brief summary: To collect information from patients with vHL disease. Information collected will include data on the status of the disease, any surgeries or therapies patients have received for vHL disease, and quality of life.

Detailed description: Primary Objectives:

* Obtain prospective and retrospective data on lesion development, surgical history and systemic therapy use in patients with vHL disease
* Assess genotype-phenotype correlation between VHL mutation type and patterns of lesion development
* Assess genotype-phenotype correlation for response to belzutifan in an organ-specific manner

Secondary Objectives:

--Obtain quality of life data in patients with vHL disease

Eligibility criteria: Inclusion Criteria:

* Presence of genetic confirmation or clinical criteria consistent with vHL disease.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Patients with psychiatric illness/social situations that would limit compliance with study requirements.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: ejonasch@mdanderson.org
name: Eric Jonasch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06504914: Preparing FIM-BCS - A Lifestyle Modification for African-American Breast Cancer Survivors
Official title: Developing FIM-BCS: A Lifestyle Modification for African-American Breast Cancer Survivors With Cardiovascular Risk Factors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Obesity
Nutrition, Healthy
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hypertension and obesity are both major risk factors for cardiovascular disease (CVD), a leading cause of death for Black women in the United States. The investigators propose examining the feasibility and acceptability of the 12-week RN-CHeFRx (Real Nourishment and Cooking Healthy Food is Rx) intervention

- grocery delivery, cooking classes, and nutrition education - for Black women with hypertension and obesity to improve nutritious eating habits and blood pressure control.

Detailed description: The objective of this study is to conduct the RN-CHeFRx (Real Nourishment and Cooking Healthy Food is Rx) for 12 weeks among Black women who are obese and hypertensive living Chicago. We propose to 1) Pilot the RN-CHEFRx intervention and measures that will be used to assess blood pressure, BMI status, and sodium intake with 20 Black women diagnosed with hypertension and BMI ≥ 30. We will assess the efficacy of the evaluation tools to be used in a future clinical trial at three-time points (baseline, 12 weeks, and 6 months); and 2) Assess the feasibility and acceptability of the RN-CHeFRx intervention using interviews, surveys, and documentary analysis. Findings from this study will inform a larger efficacy trial of RN-CHeFRx to improve dietary behaviors and blood pressure control among Black women with hypertension and obesity

Eligibility criteria: Inclusion Criteria:

* self-identified as Black or of African descent
* female
* ≥ 18 years old
* baseline blood pressure ≥130/85 or diagnosed with hypertension and BMI ≥ 30

Exclusion Criteria:

* inability to cook in their homes
* cognitive deficits impeding the ability to participate or provide informed consent
* current treatment for cancer
* liver or renal disease
* pregnancy
* lack of English language proficiency

Primary outcomes:
measure: Number of participants who complete the 12 week intervention
timeFrame: [Time Frame: Up to 12 weeks]
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
Study officials:
References:
Clinical trial NCT05942014: Correlation of Children's Electronic Screen Time Exposure and Dental Anxiety and Behavior
Official title: Correlation of Children's Electronic Screen Time Exposure and Dental Anxiety and Behavior in a Group of Egyptian Children
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Children's Screen Exposure
Keywords: dental anxiety
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 211
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All medically free male and female Egyptian children with age from 6 to 8 years that have a first dental visit

Brief summary: This study aims to detect the correlation between children's electronic screen time exposure and dental anxiety and behavior in a group of Egyptian children


Eligibility criteria: Inclusion Criteria:

* Healthy children aged 6-to-8-years old
* First dental visit
* Both genders

Exclusion Criteria:

* Children with Mental or neurological disorders.
* Children with Systemic disorders.
* Children who use medications that could interfere with the central nervous system
* Children with previous hospitalization

Primary outcomes:
measure: Child dental anxiety
timeFrame: "through study completion, an average of 1 year"
measure: Assessment of the child's behavior during the dental visit
timeFrame: "through study completion, an average of 1 year"
Secondary outcomes:
measure: Exposure to electronic screens
timeFrame: "through study completion, an average of 1 year"
Other outcomes:
Locations:
Study officials:
References:
citation: Mobarek NH, Khalil AM, Talaat DM. Exposure to Electronic Screens and Children's Anxiety and Behavior During Dental Treatment. J Dent Child (Chic). 2019 Sep 15;86(3):139-144.
citation: Alaki SM, Al-Raddadi RA, Sabbagh HJ. Children's electronic screen time exposure and its relationship to dental anxiety and behavior. J Taibah Univ Med Sci. 2023 Jan 10;18(4):778-786. doi: 10.1016/j.jtumed.2022.12.021. eCollection 2023 Aug.
Clinical trial NCT05039814: Prediction of Postoperative Acute Kidney Injury in Patients With Acute Type A Aortic Dissection Using Cystatin C
Official title: Prediction of Postoperative Acute Kidney Injury in Patients With Acute Type A Aortic Dissection Using Cystatin C
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Dissection
Acute Kidney Injury
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients sufferred acute type A aortic dissection

Brief summary: The research aimed to predict postoperative acute kidney injury in patients with acute type A aortic dissection preliminarily by exploring the correlation of preoperative cystatin C level and incidence of postoperative acute kidney injury and combining with relevant risk factors.


Eligibility criteria: Inclusion Criteria:

1. 18-80 years old
2. Acute type A aortic dissection diagnosed by CT angiography

Exclusion Criteria:

1. History of chronic kidney disease
2. History of cardiovascular operation
3. Pregnancy status

Primary outcomes:
measure: postoperative acute kidney injury
timeFrame: From date of operation until the date of acute kidney injury or date of death from any cause, whichever came first, assessed up to 30 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Department of cardiac surgery, Qilu Hospital, Shandong University
name: Xin Zhao
role: PRINCIPAL_INVESTIGATOR
References: