louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00775047: Pharmacist-Administered Injections for Contraception
Official title: Pharmacist-Administered Injections of Depo-Medroxyprogesterone Acetate for Contraception: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: depo medroxyprogesterone acetate
Depo Provera
contraceptive compliance
pharmacists
Compliance in receiving additional Depo Provera injections
Satisfaction in receiving Depo Provera injections at a pharmacy compared with usual clinic
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-10-17
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to see if it is a feasible arrangement to have women receive their second and third birth control injection (with Depo-Provera) at a pharmacy compared with receiving it a Planned Parenthood Clinic. Compliance with returning for injections as well as patient satisfaction with the method, providers, and location where injection was received will be assessed and compared between the two sites. The hypothesis is that there will be no difference in return rates for injections at either the pharmacy or the clinic site.

Detailed description: Women who want to use or are currently using Depo-Provera for contraception will be randomized to receive their next two injections either back at the Planned Parenthood clinic or at a local pharmacy where pharmacists are trained to give injections. After each injection, women will be asked to complete a questionnaire to assess their attitudes about the method of birth control, their providers, and the location where they received the injection.

Eligibility criteria: Inclusion Criteria:

* At least 18 y.o., English speaking/reading, presenting to Planned Parenthood to use Depo Provera (restarting, first use, or continuing use)

Exclusion Criteria:

* Under 18 years of age, English illiterate (reading and verbal)

Primary outcomes:
measure: Compliance in returning for 3 month and 6 month injections
timeFrame: 3 months and 6 months after first injection
Secondary outcomes:
measure: Attitudes about clinical setting
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Planned Parenthood of Central North Carolina
state: North Carolina
Study officials:
affiliation: Dept. of Social Medicine, University of North Carolina
name: Carla Picardo, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05053347: The Effect of Alpha Linolenic Acid Intake on Patients With Elevated Glycemic Status
Official title: The Effect of Alpha Linolenic Acid Intake on Patients With Elevated Glycemic Status: a Double-blind Randomized Controlled Cross-over Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Elevated Blood Sugar
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 128
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The findings of previous experiments suggested that alpha linolenic acid (ALA) has been linked to anti-hyperglycemic, and reducing the risk of diabetes.This is a randomized double-blind cross-over trial, aims to study the effect of ALA on glycemic status and human metabolism. Firstly, the investigators will investigate the efficacy of ALA on improving the indexes of glucose metabolism. Secondly, next generation sequencing (NGS), ultra-high performance liquid chromatography-tandem mass spectrometric (UPLC-MS/MS) and gas chromatography-mass spectrometry detection will be conducted to explore the role of ALA on gut microbiota as well as metabolites. Thirdly, single nucleotide polymorphism will be genotyped by Time-of-flight mass spectrometry to find the gene-environment interaction effect.


Eligibility criteria: Inclusion Criteria:

* Fasting blood glucose 6.1-8.4mmol /L;
* HBA1c 5.7-7.0%;
* OGTT 2h or postprandial blood glucose 7.8-11.1 mmol/L;
* Patients with previously diagnosed type 2 diabetes with stable drug hypoglycemic treatment and blood glucose controlled well.

Exclusion Criteria:

* Under 30 years old or over 75 years old;
* Suffering from severe obesity, thyroid disease, or other serious diseases, such as mental illness;
* Take nutritional supplements, such as fish oil capsules, Perilla seed oil and flaxseed oil capsules, for nearly one month;
* Intake more than 20g walnuts per day or more than 100g fatty fish per week in the last month;
* Daily cooking oil is linseed oil or rapeseed oil and other α -linolenic acid rich vegetable oil;
* Have been diagnosed with type 2 diabetes and are currently receiving insulin injection;
* Allergic to the content of intervention;
* Failure to eat the tested sample as prescribed and affect the efficacy or safety judgment.

Primary outcomes:
measure: changes of HbA1c
timeFrame: 0 week，12th week, 20th week and 32th week in the intervention period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04327947: Evaluation of Gynecological Acceptability of 3 Health Care Products
Official title: Evaluation of Gynecological Acceptability of 3 Health Care Products (Intimate Gel)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrophic Vaginitis
Vaginal Disease
Lead sponsor: Herbarium Laboratorio Botanico Ltda
Sponsor class: INDUSTRY
First posted: 2020-03-31
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical trial, triple arm, randomized
Primary purpose: TREATMENT

Brief summary: The research was conduct with 3 different products for use in the intimate region in up to 70 research participants, that use the investigational product by 35 ± 2 days. The subjects were follow up throughout the study by a gynecologist for verification of safety, effectiveness and possible adverse events.

Detailed description: At this study, 70 female participants, 18 to 70 years, healthy with complaints of vaginal dryness used the 3 investigational product, each one by 9 days. Between the changes of product use, there were 4 days of wash out. At the 9th day, the participants answered assessment questionnaire.

Eligibility criteria: Inclusion Criteria:

* Health volunteers
* Non-injured mucosa in the test region;
* Agreement to adhere to study procedures and requirements and attend the institute on the day(s) and time(s) determined for the evaluations;
* Ability to consent to their participation in the study;
* Age from 18 to 70 years old;
* Female participants;
* Vaginal dryness (slight minimum) - according to questions from the gynecologist.

Exclusion Criteria:

* Pregnancy or breastfeeding;
* Skin pathology in the area of application of the product;
* Diabetes Mellitus type 1; insulin-dependent diabetes; presence of complications due to diabetes (retinopathy, nephropathy, neuropathy); presence of diabetes-related dermatoses (plantar ulcer, lipoid necrobiosis, annular granuloma, opportunistic infections); history of episodes of hypoglycemia, diabetic ketoacidosis and/or hyperosmolar coma;
* Current use of the following medications for topical or systemic use:

corticosteroids, immunosuppressants and antihistamines;

* Skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis;
* History of reaction to the category of the tested product;
* Other diseases or medications that may directly interfere with the study or endanger the health of the research participant.

Primary outcomes:
measure: Perceived hydration
timeFrame: 9 days
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Allergisa Pesquisa Dermato-Cosmética Ltda
Study officials:
References:
Clinical trial NCT06621147: Application of Machine Learning Algorithms to Identify Optimal Candidates for Primary Tumor Resection in Patients with Metastatic Non-small Cell Neuroendocrine Tumors
Official title: Application of Machine Learning Algorithms to Identify Optimal Candidates for Primary Tumor Resection in Patients with Metastatic Non-small Cell Neuroendocrine Tumors: Propensity Score Matching
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer - Non Small Cell
Keywords: lung cancer
machine learning
non-small cell neuroendocrine tumor
Lead sponsor: Nanchang University
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Nanchang University
First posted: 2024-10-01
Enrollment: 1776
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with metastatic non-small cell neuroendocrine tumors

Brief summary: This study was based on public use data from the SEER database. The study did not require informed consent from the SEER registered cases, and the authors obtained Limited-Use Data Agreements from SEER.

Detailed description: This study utilized publicly available data from the SEER (Surveillance, Epidemiology, and End Results) database, which is a comprehensive source of information on cancer statistics in the United States. The authors did not need to obtain informed consent from individuals whose cases are registered in the SEER database because the data is anonymized and is meant for public use. Instead, the authors acquired Limited-Use Data Agreements with SEER, which are legal contracts that allow researchers to access and use specific datasets under certain conditions while ensuring that the privacy of the individuals in the database is maintained. This agreement outlines the terms of data use, ensuring that the researchers adhere to guidelines for the ethical handling of data while still enabling them to conduct their research.

Eligibility criteria: Inclusion Criteria:

* Pathologic Diagnosis of Non-Small Cell Neuroendocrine Carcinoma
* Known Surgical Information

Exclusion Criteria:

* Small cell lung cancer
* Age less than 18 years

Primary outcomes:
measure: Overall survival
timeFrame: The estimated time period for assessing events was January 2000 through December 2021. It is the time from random assignment to death from any cause (last follow-up for lost patients; end of follow-up for patients still alive at the end of the study).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04013347: Outcomes of Resection at Different Times Between the End of Neoadjuvant Treatment and Surgery
Official title: Evaluation of Anatomopathological, Oncological and Surgical Outcomes in Relation to the Different Times Between the End of Neoadjuvant Treatment and Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoadjuvant Chemoradiotherapy
Rectal Tumor
Surgery
Surgery--Complications
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: One hundred and sixty-seven patients with rectal adenocarcinoma who underwent to resection after combined NRCT at University Campus Bio-Medico di Roma from January 2005 to March 2015 were retrospectively analysed.

Brief summary: Neoadjuvant radio-chemotherapy (NRCT) represents a milestone in the treatment of selected rectal tumours. Ideal time interval between the end of NRCT and surgery is still debated; a 6-8 weeks time interval is considered optimal, but shorter or longer intervals have been associated with better oncological outcomes. Moreover, there is a lack of data about clinical postoperative outcomes and different time intervals after the end of NRCT. Here, effect that different time intervals have on postoperative complications with particular regard to the anastomotic dehiscence have been evaluated.

Methods One hundred-sixty-seven patients underwent surgery after long-course NRCT. Three different time intervals were considered: (0-42; 43-56; \>57 days).

Detailed description: Neoadjuvant radio-chemotherapy (NRCT) represents a milestone in the treatment of selected rectal adenocarcinoma. Even though a 6-8 weeks' time interval after the end of NRCT and surgery is considered ideal, the optimal time for surgery is still controversial.

Eligibility criteria: Inclusion Criteria:

- patients with rectal adenocarcinoma who underwent to resection after combined NRCT at University Campus Bio-Medico di Roma from January 2005 to March 2015.

To evaluate the anastomotic dehiscence were excluded patients undergone to Abdomino-perineal resection (APR) and 4 patients for whom data were not available.

Primary outcomes:
measure: number of patient with low tumor regression grade
timeFrame: 1 week after surgery
measure: number of patient with surgical complications
timeFrame: 1 month after surgery
Secondary outcomes:
measure: number of patient with anastomotic dehiscence
timeFrame: 1 month after surgery
Other outcomes:
Locations:
Study officials:
References:
citation: Caputo D, Angeletti S, Fiore M, Ciccozzi M, Coppola A, Cartillone M, La Vaccara V, Spagnolo G, Trodella L, Coppola R. Delayed surgery after radio-chemotherapy for rectal adenocarcinoma is protective for anastomotic dehiscence: a single-center observational retrospective cohort study. Updates Surg. 2020 Jun;72(2):469-475. doi: 10.1007/s13304-020-00770-1. Epub 2020 Apr 18.
Clinical trial NCT06859047: The Echodynamic Approach
Official title: Comprehensive Hemodynamic Assessment Via Echocardiography: the Echodynamic Approach Compared to Right Heart Catheterization
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Echocardiography, Transthoracic
Right-heart Hemodynamics
Keywords: hemodynamics
right heart catheterization
echocardiography
echodynamics
Lead sponsor: IRCCS Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 200
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: The study population consists of patients from multiple centers who received, within a short time frame (the same day), an invasive assessment of hemodynamic parameters through right heart catheterization and a non-invasive assessment through echocardiography.

Brief summary: The aim of this prospective observational study is to assess the accuracy of non-invasive hemodynamic parameter estimation via trans-thoracic echocardiography (TTE) compared to the invasive gold standard of right heart catheterization (RHC). This study will include patients who undergo both TTE and RHC on the same day, under the same hemodynamic conditions. The primary research question is: how does the echodynamic evaluation perform compared to right heart catheterization?

Detailed description: The non-invasive echocardiographic assessment will be used to esimate via mathematic formulas all the direct and indirect paramethers obtained from the right side catheterization. Each value obtained from the model using echocardiographic paramethers will be compared to the invasive finding.

Eligibility criteria: Inclusion Criteria:

* Clinical need for an invasive hemodynamic assessment and an echocardiographic evaluation on the same day

Exclusion Criteria:

* Incomplete hemodynamic assessment for any reason

Primary outcomes:
measure: Cardiac output
timeFrame: Baseline
measure: Pulmonary artery pressure
timeFrame: Baseline
measure: Pulmonary vascular resistance
timeFrame: Baseline
measure: Right atrial pressure
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Ospedale Generale regionale "F.Miulli"
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo Pavia
Study officials:
References:
Clinical trial NCT01374347: Brain SPECT Following Cialis (Tadalafil ) Administration
Official title: Brain SPECT Perfusion Imaging Following Cialis (Tadalafil ) Administration in Patients With Vascular Risk Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Change in Brain Perfusion
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-06-15
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients in the age range of 35-75 years.

Brief summary: The study will be an open label one and will include 30 patients who underwent ischemic stroke 3 month to 3 years prior to the study. All patients will undergone a baseline brain SPECT perfusion study. 15 patients will take one dose of 20 mg cialis, and will have a second brain SPECT 24 hours after cialis administration. 15 other patients (age and risk factor matched) will be prescribed 5 mg of cialis once daily for 7 days, and a second SPECT study will be performed 24 hours after the last dose.


Eligibility criteria: Inclusion Criteria:

* Male and female patients in the age range of 35-75 years.

Exclusion Criteria:

1. known allergic reaction to TF
2. Medical contraindication to use TF
3. Hemorrhagic stroke including intracerebral hemorrhage and subarachnoid hemorrhage
4. Acute stroke or cardiac ischemic event up to 3 month prior to study.
5. Other neurological brain diseases including degenerative diseases, multiple sclerosis, brain tumors, post severe brain injury (TBI) and migraine headache.
6. Sensory aphasia.
7. Cognitive impairment with disability to sign a consent form.Patients' Assessment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05387798: A Phase 3 Extension Study of RAD011 (Cannabidiol Oral Solution) in Patients With Prader-Willi Syndrome
Official title: A Phase 3, Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of RAD011 (Cannabidiol Oral Solution) in Patients With Prader-Willi Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Prader-Willi Syndrome
Lead sponsor: Radius Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-24
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 3 open-label extension (OLE) study in patients diagnosed with Prader-Willi Syndrome (PWS) who completed the Maintenance Period of the randomized, placebo-controlled Phase 2/3 study SCOUT-015.

The primary objective of this study is to assess the long-term safety and tolerability of RAD011.


Eligibility criteria: Inclusion Criteria:

* Presence of a parent/legal guardian that is able to consent for their participation. Parent/caregiver/legal guardian can complete the required assessments throughout the study. Patient Consent/Assent will be obtained if the patient is 8 years of age or older and has the mental capacity to understand and sign a written consent/assent form and/or give verbal assent;
* Patient completed treatment on the SCOUT-015 study through Visit 14 (Week 34);
* If female, is either not of childbearing potential (defined as premenarchal or surgically sterile \[bilateral tubal ligation, bilateral oophorectomy, or hysterectomy\]) or practicing one of the following medically acceptable methods of birth control up to 4 weeks after the last dose of

RAD011 or placebo:

Exclusion Criteria:

* Significant acute condition (active infection, uncontrolled diabetes, any other uncontrolled chronic condition) including but not limited to clinically significant laboratory abnormality, or medical or psychosocial condition that may preclude the patient from participating in the study, at the Investigator's discretion;
* Positive urine test for drugs of abuse, including tetrahydrocannabinol (THC), or known history of drug, alcohol, or substance abuse;
* Significant risk of committing suicide based on history, psychiatric examination, or based on the Investigator's judgment;
* Significant non-compliance issues (IP misuse or abuse, study visit participation, etc.) during the patient's SCOUT-015 participation based on the Investigator's judgement.
* Pregnant (determined by a positive urine pregnancy test) or lactating female;
* Concurrent participation in any other interventional study involving an investigational product, gene therapy, or device.

Primary outcomes:
measure: Assess the safety of RAD011 by evaluating the incidence and severity of adverse events reported
timeFrame: Baseline through Week 52
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: