louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01573377: Efficacy of Metformin and Diane-35 on PCOS Patients,a Randomized, Controlled, Prospective Clinical Trial
Official title: Efficacy of Metformin and Diane-35 on PCOS Patients,a Randomized, Controlled, Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Insulin Resistance
Keywords: polycystic ovary syndrome
insulin resistance
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2012-04-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Polycystic ovary syndrome (PCOS) is one of the most common endocrinopathies in reproductive-age women, and it affects 5-7% of this group. It is characterized by disturbed menstrual cycle, ovulatory dysfunction and hyperandrogenism. Over 40% of PCOS women might become the patients with impaired glucose tolerance or type 2 diabetes. It has been confirmed that insulin resistance (IR) is a common feature in PCOS and adipokines might play roles in the pathogenesis of IR and PCOS, because these adipokines have wide-ranging effects on carbohydrate and lipid metabolism.

The present clinical trial intends to compare the effects of metformin and oral contraceptives on PCOS patients, focusing on the insulin sensitivity, ovulation, and menstrual cycle etc. The investigators also aim to study the effects of metformin on serum adipokine levels(such as pigment epithelium-derived factor, progranulin etc.)in PCOS patients.


Eligibility criteria: Inclusion Criteria:

with at least two of the following features : (i) oligo-amenorrhea or chronic anovulation; (ii) clinical and/or biochemical hyperandrogenism; (iii) ultrasound appearance of polycystic ovaries

Exclusion Criteria:

- other known causes of hyperandrogenemia and ovulatory dysfunction, including 21-hydroxylase deficiency, congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors, thyroid disease, and hyperprolactinemia.

use of hormone medications (including oral contraceptives) within the past month and the use of medicines that affect insulin sensitivity (e.g., metformin or thiazolidinediones) within the past three months

Primary outcomes:
measure: the efficacy of Metformin and Diane-35
timeFrame: at 12 weeks
Secondary outcomes:
measure: changes of adipokine（PEDF,GPRN，etc）levels from baseline
timeFrame: at 12 weeks
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Qifu Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02944877: HOPE Social Media Intervention for HIV Testing and Studying Social Networks
Official title: HOPE Social Media Intervention for HIV Testing and Studying Social Networks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: National Institute of Mental Health (NIMH)
First posted: 2016-10-26
Enrollment: 900
Sex: MALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study \[HOPE: Harnessing Online Peer Education\] seeks to determine the efficacy of using online social networks to scale peer community leader models to increase HIV prevention within African-American and Latino men who have sex with men. The peer community leader model, which teaches community popular opinion leaders about how to disseminate behavior changes messages throughout the community, has been proven to increase HIV prevention behaviors. Social media and online communities, such as Facebook, may be a cost-effective platform for scaling these models. Primarily upper middle-class White populations used the Internet in its early years, however, Internet use within African-American and Latino households has recently increased dramatically, especially on social media. People using the Internet may be at the highest risk for contracting HIV and are using novel Internet approaches to find sex partners, such as through social media. This is the first study to examine the effectiveness of the HOPE social media intervention to increase HIV testing among at-risk groups in the United States.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Male
* Sexually active with another man in the last 12 months
* Willing and capable of understanding and assenting to an online informed consent form
* Has (or willing to create) a social media page.

Exclusion Criteria:

* Does not satisfy inclusion criteria

Primary outcomes:
measure: Number of Participants Requesting HIV Self-Testing
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: Sean Young
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06123377: Angiogenic Factors in the Conservative Management of Gestational Hypertension
Official title: Use of Angiogenic Factors in the Conservative Management of Gestational Hypertension. Prospective, Randomised, Controlled Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Hypertension
Keywords: Gestational hypertension
Angiogenic factors
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypertensive disorders of pregnancy (HPT) are an important cause of maternal-feto-neonatal morbidity and mortality, being one of the three leading causes of maternal death in our country and in developing countries. The only cure for THE is termination of pregnancy, which ends up being a decision in which gestational age and maternal risks must be balanced. Angiogenic factors have come to occupy an indispensable place in the arsenal of tools that can be used to separate the patient with a high likelihood of complications from those in whom prolongation of pregnancy could represent an important neonatal benefit. One of the most controversial scenarios is gestational hypertension, a group of hypertensive disorders considered the mildest form of the pre-eclamptic spectrum, where current recommendations indicate termination of pregnancy at 37 weeks. However, the decision is based on outdated guidelines developed at a time when angiogenic factors were just beginning to be known. The purpose of the study is to use angiogenic factors as a guide to decide the most appropriate gestational age for termination of pregnancy in patients diagnosed with gestational hypertension.


Eligibility criteria: Inclusion Criteria:

* Pregnant women between 24 and 40 weeks of gestation.
* Diagnosis of Gestational Hypertension based on ACOG criteria
* index sFlt-1/PIGF equal or below 33

Exclusion Criteria:

* Multiple gestation
* Maternal vasculitis
* Previous cesarean section (3 or more)
* Neurological conditions
* Chronic renal disease
* Purpura
* Heart disease
* Index sFlt-1/PIGF of 34 or more

Primary outcomes:
measure: Progression to preeclampsia
timeFrame: From the moment of randomization up until delivery. Between 1 and 17 weeks.
Secondary outcomes:
measure: Maternal / fetal morbidity
timeFrame: Up until discharge. On average, 7 days
measure: Neonatal morbidity
timeFrame: Up until discharge. On average, 3 days
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Hospital Santo Tomas
Study officials:
References:
Clinical trial NCT03185377: Registry for Chronic Obstructive Pulmonary Disease With Pulmonary Thromboembolism in China
Official title: The Study of Early Detection, Disease Course and Prognosis of Pulmonary Thromboembolism in Chronic Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
PTE - Pulmonary Thromboembolism
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 1708
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients

Brief summary: Chronic obstructive pulmonary disease (COPD) is closely related to venous thromboembolism (VTE). But it is difficult to identify VTE in COPD patients in clinical practice. Therefore, the prevalence data of PTE in COPD is limited. Pulmonary thromboembolism (PTE) is an important factor effecting patients outcomes, but existing researches only have short follow-up time less than 1 year. This study aim to develop an early detection system of PTE in COPD and explore the disease course and prognosis.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized for chronic obstructive pulmonary disease (COPD) exacerbation

Exclusion Criteria:

* Stable COPD patients
* COPD hospitalized for definite causes other than pulmonary thromboembolism
* Patients with malignant tumor
* Patients with contraindications for CT pulmonary angiography
* Psychopath

Primary outcomes:
measure: All-cause mortality
timeFrame: 3 years
Secondary outcomes:
measure: COPD exacerbations
timeFrame: 3 years
measure: venous thromboembolism recurrence
timeFrame: 3 years
measure: major bleeding
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01122277: Rational Fluid Therapy in Germany
Official title: Klinisches Register RaFTinG - Rational Fluid Therapy in Germany
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients in ICU
Keywords: Volume therapy
Fluid therapy
Patients in ICU
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: University Hospital Muenster
name: Fresenius Kabi, Bad Homburg, Germany
First posted: 2010-05-13
Enrollment: 4000
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: Patients in intensive care units with an indication for fluid/volume therapy

Brief summary: The purpose of this observational study is the prospective documentation and evaluation of the status quo of volume therapy in German intensive care units.

Detailed description: The purpose of RaFTinG is the prospective documentation and evaluation of the demographic, diagnostic and therapeutic characteristics of unselected patients and their treatment in intensive care units (ICU) in Germany.

Documentation will not only include their stay in the ICU but a follow up query 90 days after discharge from the ICU.

Eligibility criteria: Inclusion Criteria:

* ICU patients with an indication for fluid/volume therapy

Exclusion Criteria:

* Patients hospitalized by order of a court of law or a government agency

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinik für Anaesthesiologie, Klinikum der Universität München
state: Bavaria
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: Nordrhein - Westfalen
Study officials:
affiliation: Klinik für Anaesthesiologie, Klinikum der Universität München
name: Matthias Jacob, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Münster, Germany
name: Christian Ertmer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinik für Anaesthesiologie, Klinikum der Universität München, Germany
name: Bernhard Zwissler, Prof
role: STUDY_CHAIR
affiliation: Universitätsklinikum Münster, Germany
name: Hugo van Aken, Prof
role: STUDY_CHAIR
References:
citation: Ertmer C, Zwissler B, Van Aken H, Christ M, Spohr F, Schneider A, Deisz R, Jacob M. Fluid therapy and outcome: a prospective observational study in 65 German intensive care units between 2010 and 2011. Ann Intensive Care. 2018 Feb 17;8(1):27. doi: 10.1186/s13613-018-0364-z.
Clinical trial NCT03275077: To Compare TEG (Thrombelastography) and Conventional Tests in CKD Patients
Official title: A Comparative Evaluation of Thromboelastogram and Conventional Coagulation Tests To Detect Coagulopathy in End Stage Renal Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Coagulopathy
Keywords: End stage renal disease
ESRD
Thromboelastography
Fibrinogen
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 100 patients were recruited for the study based on the above criteria.Following enrollment, patients were divided into two groups as follows Group 1(Control Group): 50 patients who were healthy voluntary donors belonging to ASA PSI or ASA PSII Group 2(ESRD Group): 50 patients suffering from end stage renal disease i.e. CKD stage 5 (Defined by KDIGO 2012) who never received renal replacement therapy (RRT

Brief summary: Background: Coagulopathy in chronic kidney disease is multifactorial. Both hypocoagulopathy and hypercoaguability are seen. Conventional tests of coagulation (CCTs) end at the formation of thrombin, and do not take into account the interaction of coagulation factors, platelets, RBC etc. By overcoming the above deficiencies, thromboelastography provides a holistic picture of blood coagulation. The present study evaluated the TEG profile of ESRD patients and compared it to CCTs and to controls.

Methods: 50 ESRD patients and 50 controls were recruited for the study. Venous samples were withdrawn and platelet count, INR and fibrinogen levels were measured. Simultaneously a Thromboelastography was performed. All samples were drawn prior to initiation of dialysis.


Eligibility criteria: Inclusion Criteria:

1. Healthy voluntary donors belonging to ASA PSI or ASA PSII
2. Patients suffering from end stage renal disease i.e. CKD stage 5 (Defined by KDIGO 2012 ) who never received renal replacement therapy (RRT)

Exclusion Criteria:

1. Patients on antiplatelet drugs, erythropoietin, desmopressin
2. Patients with known bleeding disorders like haemophilia, aplastic anaemia etc
3. Patients having coexisting liver diseases
4. Patients on dialysis
5. Patients who have received PRBC, FFPs or Platelet Transfusions in the past 3 months
6. Patients less than 18 years of age
7. Pregnant patients
8. Malignancy

Primary outcomes:
measure: To compare the maximum amplitude on a thromboelastography in patients of chronic kidney disease stage 5 with normal controls.
timeFrame: 0 hr
Secondary outcomes:
measure: To correlate the maximum amplitude with platelet count and fibrinogen levels in patients of chronic kidney disease
timeFrame: 0 hr
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03028077: Effects of GS-3K8 and GINst15 on Acute Respiratory Illness
Official title: The Efficacy and Safety of GS-3K8 and GINst15 on Acute Respiratory Illness in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Infection
Keywords: ultrafiltered red ginseng
hydrolyzed ginseng
acute respiratory illness
clinical trial
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 45
Sex: ALL
Minimum age (years): 39
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was conducted to investigate the effects of daily supplementation of GS-3K8 or GINst15 on acute respiratory illness (ARI) in healthy subjects.

Detailed description: This study was a 8 weeks, randomized, double-blind, placebo-controlled trial. Forty five subjects were randomly divided into GS-3K8 (Ultrafiltered red ginseng extract) or GINst15 (Hydrolyzed ginseng extract) or placebo group. The primary clinical outcome measure was the incidence of ARI. The secondary clinical outcome measure was the development and duration of ARI symptoms.

Eligibility criteria: Inclusion Criteria:

* Age 39-65 years with healthy adults

Exclusion Criteria:

* Subjects had been vaccinated against influenza in the previous 6 months
* Subjects with symptoms of upper respiratory tract infection
* Subjects with acute/chronic disease
* History of alcohol or substance abuse
* History of disease that could interfere with the test products or impede their absorption
* Subjects taking medications such as immune or upper respiratory tract infection related drug or functional foods
* Abnormal liver or kidney function tests
* Pregnant or lactating women and heavy smokers
* Being judged by the responsible physician of the local study center as unfit to participate in the study

Primary outcomes:
measure: Incidence rate of ARI (by questionnaire)
timeFrame: 18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)
Secondary outcomes:
measure: Development of ARI symptoms (by questionnaire)
timeFrame: 18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)
measure: Duration of ARI symptoms (by questionnaire)
timeFrame: 18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Chonbuk National University Hospital
name: Jeong Hwan Hwang, M.D. Ph. D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03037177: Mediastinal Grey Zone Lymphoma From the LYSA
Official title: Mediastinal Grey Zone Lymphoma: Clinico-pathological Characteristics and Outcomes of 99 Patients From the LYSA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mediastinal Grey Zone Lymphoma
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-01-31
Enrollment: 99
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We retrospectively identified cases treated in French, Belgium and Portuguese LYSA centers suspected to be MGZL using local pathological records, records from LYSA centers and the LYMPHOPATH network, which aims to review all newly diagnosed lymphoma cases in France (14). All the FFPE blocks and immunohistochemistry (IHC) slides (obtained prior any treatment) were centralized in the LYSA-Pathology (LYSA-P) department located in Henri Mondor hospital in Paris to perform a central review by a panel of hematopathologists. Two hundred and four cases were reviewed by the panel of LYSA hematopathologists.

Brief summary: Mediastinal grey zone lymphoma, B cell lymphomas with intermediate features between classical Hodgkin lymphoma and primary mediastinal B cell lymphoma, are not well described in the literature. Investigators report the clinical characteristics and outcomes of a large retrospective series of 99 cases centrally reviewed by a panel of hematopathologists, with a consensus established for the diagnosis.


Eligibility criteria: Inclusion Criteria:

* cases with an intermediate morphology and phenotype between CHL and PMBCL were included after central pathological review

Exclusion Criteria:

* Cases of CHL with partial CD20 expression or low expression in tumoral cells were excluded and considered as CD20-positive CHL
* Exclusion of sequential form patients (with a diagnostic biopsy of PMBCL and a relapse biopsy of CHL or vise-versa) as they represent a biases for statistical analysis.

Primary outcomes:
measure: EFS in the global population of GZL
timeFrame: EFS: Event Free Survival from date of randomization until the date of first documented progression, up to 130 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre Bénite
country: France
facility: Centre hospitalier Lyon sud
state: Rhône Alpes
Study officials:
References:
Clinical trial NCT06730477: Plasma Exosomes Reveal the Efficacy of Targeted Therapy in Patients With EGFR Mutation in Lung Adenocarcinoma
Official title: Based on Plasma Exosomes Combined With Multi-omics Analysis to Reveal the Trajectory of Targeted Therapy Resistance and Novel Target Intervention Therapy in Patients With EGFR Mutation in Lung Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Lung Adenocarcinoma
EGFR Activating Mutation
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
Collaborators: name: Yichang Central People's Hospital
name: Suizhou Hospital, Hubei University of Medicine
First posted: 2024-12-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From January 2021 to December 2026, about 500 patients with EGFR-mutated lung adenocarcinoma who receive targeted therapy with or without chemotherapy as first-line treatment will be included in this cohort study

Brief summary: The objective of this observational study is to explore the therapeutic trajectory of targeted therapy in lung adenocarcinoma patients with epidermal growth factor receptor (EGFR) mutations. The main objective is to identify potential biomarkers that can predict the efficacy of targeted therapy through plasma exosomes and to explore strategies to reverse drug resistance to targeted therapy. Biological specimens and medical imaging data will be collected from patients already receiving targeted therapy as a first-line treatment, and followed-up will be conducted to analyze prognosis based on different patterns.

Detailed description: The medical imaging data will be collected retrospectively and prospectively, and the blood samples and tumor tissues will be collected prospectively.

Eligibility criteria: Inclusion Criteria:

* Pathological examination confirmed lung adenocarcinoma
* No other type of tumor was present
* Common sensitive EGFR (Ex19Del L858R or combined with other sites) mutations have been identified
* Receive targeted therapy with or without chemotherapy as first-line treatment
* ≥ 18 years and ≤80 years old

Exclusion Criteria:

* History of other malignant tumors
* Irregular treatment or poor compliance
* Incomplete clinical information or lost to follow-up

Primary outcomes:
measure: progression-free survival
timeFrame: A two-year period after starting treatment (Regular follow-up every three months after receiving targeted therapy combined with or without chemotherapy as first-line treatment)
Secondary outcomes:
measure: Overall survival
timeFrame: A three-year period after starting treatment (Regular follow-up every six months after receiving targeted therapy combined with or without chemotherapy as first-line treatment)
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union hospital, Tongji Medical college, Huazhong University of Science and Technology
state: Hubei
Study officials:
References: