louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00733278: Intrauterine Contraceptive Device (IUD) Placement at Time of C-Section
Official title: Acceptability and Technical Feasibility of Insertion of a Copper IUD at Time of Elective C-section: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Keywords: Postpartum contraception
Copper IUD
Lead sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Sponsor class: OTHER
First posted: 2008-08-13
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study of up to 10 women, which will test the hypothesis that the placement of copper IUDs through the uterine incision at the time of uncomplicated elective C-section is technically feasible and acceptable to women seeking long-term contraception.

Detailed description: Women will be enrolled in this study during late prenatal care. Consent for placement of the IUD will be verified prior to elective C-section. After removal of the placenta, the copper IUD will be placed through the incision at the fundus and the tail strings will be delivered through the cervix. Data will be collected about patient bleeding and possible infection during the immediate postoperative period. The visibility of the strings will be verified at discharge and at 2 and 6 weeks postpartum. Fundal placement of the IUD will be verified by ultrasound at the patient's last visit.

Eligibility criteria: Inclusion Criteria:

* Pregnant woman
* Requires elective C-section
* Desires long-term contraception

Exclusion Criteria:

* Contraindications to copper IUD

Primary outcomes:
measure: Successful Retention of IUD
timeFrame: 6 weeks
Secondary outcomes:
measure: Visibility Within the Vagina of IUD Strings at All Times.
timeFrame: At 3 days, 2 weeks and 6 weeks postpartum
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Los Angeles BRI
state: California
Study officials:
affiliation: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
name: Anita L Nelson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05255978: A Prospective/Retrospective, Observational Follow-up Study of Chronic Hepatitis B With Non-alcoholic Fatty Liver Disease.
Official title: A Prospective/Retrospective, Observational Follow-up Study of Chronic Hepatitis B With Non-alcoholic Fatty Liver Disease.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: the Effect of NAFLD on CHB
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: age \> 18 years chronic hepatitis B patients

Brief summary: This is a prospective/retrospective, observational follow-up study of effects of fatty liver on chronic hepatitis B. Patients will join this study who undergo transient elastography with liver stiffness (LS) and CAP measurements or Ultrasonic examination. All recruited subjects will undergo comprehensive clinical, anthropometric and laboratory assessments at the time when transient elastography or Ultrasonic examination is performed. We plan to compare the relationship between chronic hepatitis B and non-alcoholic fatty liver disease. Patients will be divided into several groups based on the demand.


Eligibility criteria: Inclusion Criteria: age \> 18 years, chronic hepatitis B patients -

Exclusion Criteria: patients with chronic hepatitis C or D and human immunodeficiency virus co-infection, excessive alcohol intake (≥30 g/d for men, ≥20 g/d for women), other chronic liver diseases (e.g. primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis, Wilson's disease), or on medications known to induce hepatic steatosis (including corticosteroids, methotrexate, and tamoxifen), and pregnancy.

-

Primary outcomes:
measure: disease progression
timeFrame: 3 years to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department and Institute of Infectious Disease
state: Hubei
Study officials:
References:
Clinical trial NCT06714578: Construction of a Risk Screening Tool for New Psychoactive Substance Misuse Among Adolescents and Young Adults
Official title: Construction of a Risk Screening Tool for New Psychoactive Substance Misuse Among Adolescents and Young Adults
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Drug Misuse
Addiction
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 1035
Sex: ALL
Minimum age (years): 14
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents and young adults aging 14-35 years old

Brief summary: The goal of this observational study is to construct a risk tool available for screening young adults and adolescents at high risk of drug misuse and provides a chance for early intervention to young adults and adolescents at high risk of drug misuse, which prevent the onset and development of drug addiction in the future.The main question it aims to answer is:

1. Explore the occurrence and influencing factors of new psychoactive substance misuse among young adults and adolescents;
2. Construct a risk prediction model for new psychoactive substance misuse among young adults and adolescents and conduct internal verification of the model;
3. Based on the results of the prediction model, select the optimal model to initially form a concise scale "Screening Tool for the Risk of New Psychoactive Substance Misuse among Young Adults and Adolescents";
4. Conduct external verification of the tool, and revise and improve the screening tool, form the final version of the screening tool, and verify the application performance of the screening tool.


Eligibility criteria: Inclusion Criteria:

* Adolescents and young adults who were aged 14-35 years;
* Adolescents and young adults could read and communicate in Chinese were invited to participate in this study

Exclusion Criteria:

* Adolescents and young adults who were unable to complete the questionnaire due to physical or psychological reasons.

Primary outcomes:
measure: Perceived risks associated with drug abuse
timeFrame: baseline
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline
measure: Prosocial Tendencies Measure (PTM)
timeFrame: baseline
measure: Achenbach Youth Self Report (YSR)
timeFrame: baseline
measure: Brief Sensation Seeking Scale for Chinese (BSSS-C)
timeFrame: baseline
measure: Power of Food Scale (PFS)
timeFrame: baseline
measure: Permissive attitude towards drug abuse
timeFrame: baseline
measure: Refusal Self-Efficacy Scale (Self-Efficacy List for Drug Users, SELD)
timeFrame: baseline
measure: Adverse childhood experiences, ACEs
timeFrame: baseline
measure: Peers drug-misuse situation
timeFrame: baseline
measure: Work experiences in special venues
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT02189278: Improving Adherence to Recommended Surveillance in Breast Cancer Survivors
Official title: Improving Adherence to Recommended Surveillance in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Surveillance
Mammography
Adherence
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-07-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evidence-based guidelines recommend cancer surveillance procedures for breast cancer survivors including physical examination, mammography, breast self-exam, and gynecologic follow-up. The early detection of recurrent and new cancers can best be achieved through the combined, on schedule use of these surveillance procedures. Yet, data suggest that up to 55% of breast cancer survivors do not undergo these procedures as recommended. This study tests a telephone-based psychosocial intervention aimed at improving adherence to recommended surveillance in breast cancer survivors. The psychosocial intervention for improving adherence is compared to treatment as usual.


Eligibility criteria: Inclusion Criteria:

* 21 years of age or older
* Diagnosis of Stage I to IIIA breast cancer
* Within 1 to 5 years post primary cancer treatment (i.e., surgery, chemotherapy, and/or radiation therapy)
* No diagnosis of recurrent breast cancer or a new primary cancer
* Able to provide meaningful consent

Exclusion Criteria:

* \< 21 years of age
* Unable to provide meaningful consent
* Surgically treated with bilateral mastectomy

Primary outcomes:
measure: Surveillance adherence
timeFrame: 15 month follow-up
Secondary outcomes:
measure: Gynecologic exam adherence
timeFrame: 15 month follow-up
measure: Breast self-exam adherence
timeFrame: 6 month follow-up
Other outcomes:
measure: Perceived benefits of surveillance
timeFrame: 6 month follow-up
measure: Perceived barriers to breast cancer surveillance
timeFrame: 6 month follow-up
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Rebecca A Shelby, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00370578: Aspiration Device in Myocardial Infarction Trial
Official title: Aspiration Device Myocardial Infarction Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Angioplasty
Keywords: STEMI, THROMBUS, ASPIRATION DEVICE, NO REFLOW
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2006-08-31
Enrollment: 100
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: Early promising data are published focusing on the role of manual thrombus aspiration devices in patients with ST segment elevation (STEMI).

The aim of our single center randomized study is to evaluate the early and late effect of thrombus aspiration device (AD) after every stage during Primary PCI in the set-up of STEMI population.

Our hypothysis is that preforming thrombus aspiration after every stage of primary PCI may give early and late advantages compared to the standard primary PCI technique.

Detailed description: ADMIT-Randomized Single Center Study with two arms:

Standard PCI versus Primary PCI, using thrombus aspiration device after ever step of the procedure.

Issues to be examined are:

1. Immediate angiographic differences between the study arms. By evaluation of: TIMI FLOW GRADE,TIMI FRAME COUNT,MYOCARDIAL BLUSH GRADE. No reflow phenomenae,
2. Infarc size evaluated by serum markers and non invasive parameters
3. In hospital major adverse cardiac events
4. Major adverse cardiac events during 30\& 180 days of follow up

Eligibility criteria: Inclusion Criteria:

* patients with STEMI\<12 from synptoms onset
* eligble for primary PCI regardless of initial TIMI flow grade.
* patients for rescue PCI after failed thrombolysis will also be included

Exclusion Criteria:

* womwn with known pregnancy or who are lactating
* pts with allergy to aspirin, clopidogrel or heparin
* inability to obtain informed consent
* known existence of life threatening diseases with a life expectency less than 6 months

Primary outcomes:
measure: Limitation of infarct size
measure: Early and follow up related (MACE)-major adverse cardiac events
Secondary outcomes:
measure: Efficacy of using aspiration device after every stage of Primary angiplasty
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek Medical Center
Study officials:
affiliation: Technion-school of medicine, Haifa, Israel
name: Yoav Turgeman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04488978: Phase 2 Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypetension
Official title: A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Essential Hypertension
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-28
Enrollment: 440
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypertension


Eligibility criteria: Inclusion Criteria:

* Patients who are 19 years or older / 75 years or younger on screening
* Signed informed consent
* Patients with Essential Hypertension
* Other inclusion applied

Exclusion Criteria:

* Orthostatic hypertension with symptom
* Other exclusion applied

Primary outcomes:
measure: The change in MSSBP between baseline and Week8.
timeFrame: Baseline and Week8
Secondary outcomes:
measure: The change in MSSBP between baseline and Week4.
timeFrame: Baseline and Week4
measure: The change in Mean Sitting Diastolic Blood Pressure between baseline and Week4 / Week8.
timeFrame: Baseline and Week4/8
measure: The proportion of patients having reached MSSBP < 140 mmHg and MSDBP < 90 mmHg at W4 and at W8.
timeFrame: Baseline and Week4/8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
References:
Clinical trial NCT06792578: Surgical Start Time and Prognosis
Official title: Association Between Surgical Start Time and Postoperative Mortality, Morbidity, and Healthcare Utilization in Elective Non-cardiac Surgeries: a Retrospective, Single-center Study Using Propensity Score Matching
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Non Cardiac Surgery
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 291051
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: The study population includes adult patients aged 18 years or older who underwent elective non-cardiac surgeries at a tertiary hospital. Patients with emergency surgeries, incomplete data on surgical start times, or missing follow-up information were excluded from the analysis. The study focuses on evaluating the impact of surgical start times (morning, afternoon, and nighttime) on postoperative outcomes, including mortality, complications, and ICU admission.

Brief summary: Surgical start times significantly impacted mortality, morbidity, and resource utilization, particularly in high-risk patients.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older
* Patients who underwent non-cardiac surgery

Exclusion Criteria:

* Emergency surgeries
* Cadaver surgeries
* Transplantation surgeries
* Patients with incomplete or missing data, such as follow-up information, operation start times, or laboratory values

Primary outcomes:
measure: 30-Day Postoperative Mortality
timeFrame: 30 days post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT06158178: Evaluation of the Predictive Role of Choline PET/CT on the Survival of Patients Affected by Prostate Cancer.
Official title: Evaluation of the Predictive Role of Choline PET/CT on the Survival of Patients Affected by Prostate Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 520
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients suffering from prostate cancer undergoing choline PET/CT at the San Raffaele hospital for restaging of the disease.

Brief summary: the increase in the serum PSA (prostate specific antigen) value following radical treatment commonly involves subsequent treatment which, in the absence of morphological evidence of disease recovery, is conducted empirically through local radiotherapy or systemic hormonal therapy. The use of PET with choline is therefore of extreme clinical interest as it allows to identify the site of disease recurrence, thus being able to direct towards a specific therapeutic treatment. The diagnostic accuracy of choline PET in identifying the location of the disease has been widely demonstrated in the literature and is comparable to those of conventional diagnostic methods previously described for the restaging of patients with prostatic disease. The real advantage of this method is the possibility of obtaining the same information as conventional methods by carrying out a single exam.


Eligibility criteria: Inclusion Criteria:

* adult patients suffering from prostate cancer who have undergone choline PET/TC

Exclusion Criteria:

* patients \< 18 years

Primary outcomes:
measure: Choline PET-CT for the restaging of patients with prostatic disease.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Irccs San Raffaele
state: Italia
Study officials:
References:
Clinical trial NCT00432978: Effect of Bosentan on Exercise Capacity at High Altitude
Official title: Effect of Bosentan on Exercise Capacity at High Altitude
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Altitude
Pulmonary Hypertension
Keywords: hypoxia
endothelin
exercise
Lead sponsor: VA Loma Linda Health Care System
Sponsor class: FED
Collaborators: name: Actelion
First posted: 2007-02-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is to determine whether bosentan will alter exercise capacity after rapid ascent to high altitude.

We hypothesize that bosentan administration will improve arterial oxygenation and exercise capacity.

Detailed description: Both the prostacyclin and the nitric oxide pathways are important in modulating hypoxic pulmonary vasoconstriction (HPV). There is little information about the role of the endothelin pathway at high altitude. The endothelin pathway involves the activation of two distinct receptors, A and B. Bosentan is a nonpeptide, specific, competitive, dual antagonist of both endothelin receptor subtypes. The primary objective of this study will be to determine the effect of endothelin receptor blockade with bosentan on exercise performance and HPV. This is a prospective, double blind, placebo-controlled, randomized cross-over study involving healthy subjects aged 25-55 years of age. Subjects will undergo echocardiography and exercise testing at low altitude (\< 500m) and at 3800m. Subjects will receive either bosentan vs. placebo and will be studied at low and high altitude on two occasions in a crossover design. Primary outcome measures will be pulmonary artery systolic pressure measured by echo-Doppler and exercise capacity. A better understanding of the role of the endothelin pathway in HPV may lead to improved treatments for some patients.

Eligibility criteria: Inclusion Criteria:

* Normal healthy subjects aged 18 - 55 years

Exclusion Criteria:

* Pregnancy
* Heart, lung or liver disease
* Use of glyburide, cyclosporin A

Primary outcomes:
measure: Exercise Capacity
measure: Pulmonary artery systolic pressure
Secondary outcomes:
measure: Hemoglobin oxygen saturation
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: VA Loma Linda Healthcare System
state: California
Study officials:
affiliation: VA Loma Linda Healthcare System
name: James D Anholm, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Loma Linda University
name: Katja Ruh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seheult RD, Ruh K, Foster GP, Anholm JD. Prophylactic bosentan does not improve exercise capacity or lower pulmonary artery systolic pressure at high altitude. Respir Physiol Neurobiol. 2009 Feb 28;165(2-3):123-30. doi: 10.1016/j.resp.2008.10.005. Epub 2008 Oct 11.
Clinical trial NCT03377478: Expanding the Pool in Lung Transplantation
Official title: Expanding the Pool in Lung Transplantation: The Use of Hepatitis C Positive Donor Lungs in Hepatitis C Negative Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Lung Transplant
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To perform a study (20 patients) utilizing Hepatitis C positive (HCV Ab+/NAT -) donor lungs for hepatitis C negative recipients with post-operative surveillance and treatment only if a recipient infection occurs.

Detailed description: The investigators are proposing a study of efficacy, in which positive donors will be used for HCV negative patients. Following lung transplantation patients will undergo HCV antibody, virus PCR, and liver function testing. Recipients whom test positive for HCV viremia for 2 consecutive tests at any point will complete 12 weeks of Sofosbuvir/velpatasvir therapy.

This initial study would enroll 20 patients and utilize donors that are young, otherwise healthy whom are Hepatitis C antibody positive but Nucleic Acid Amplification Testing (NAT) negative (HCV Ab+/NAT-). The recipients would be limited to those patients who have previously consented to receive a high risk lung transplant, consented to participant in this study, and who are physiologically optimized for transplantation (e.g., low risk for lung transplantation).

Eligibility criteria: Inclusion Criteria:

* Patients who sign the informed consent for this study
* Patients whom agree to receive a PHS high risk organ
* Patients listed for heart transplantation
* Age 18-65

Exclusion Criteria:

* Patients who do not sign informed consent for this study
* HIV Seropositivity
* HBV Seropositivity (HBcAb and/or HBsAg positive)
* Abnormal liver enzymes - 3 times the normal liver function values (Bilirubin, INR, AST, ALT)
* Acute or chronic renal insufficiency (creatinine clearance \<50 ml/min) or history of dialysis
* Patients on ECMO
* Respiratory insufficiency requiring mechanical respiratory support (ventilator, BiPAP)
* Liver insufficiency
* Prior history of hepatitis C
* Allergy to Sofosbuvir/velpatasvir
* Pregnancy

Primary outcomes:
measure: HCV Viremia
timeFrame: at 2 years
measure: Seroconversion
timeFrame: at 2 years
measure: Liver Function Testing
timeFrame: at 2 years
measure: Survival
timeFrame: at 2 years
Secondary outcomes:
measure: Rejection
timeFrame: at 2 years
measure: Waitlist
timeFrame: at 2 years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
Study officials:
affiliation: Assistant Professor of Surgery/University of Pittsburgh
name: Pablo Sanchez, MD
role: PRINCIPAL_INVESTIGATOR
References: