louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03683680: Prospectively Collected Pleural Biopsies for Validation of Malignant Pleural Mesothelioma Prognostic Biomarkers
Official title: Prospectively Collected Pleural Biopsies for Validation of Malignant Pleural Mesothelioma Prognostic Biomarkers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mesothelioma
Keywords: Mesothelioma
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-09-25
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This research study is evaluating a new method for determining stage and prognosis of individuals with malignant pleural mesothelioma.

Detailed description: The purpose of this research study is to test a new method for determining the stage and prognosis of patients with malignant pleural mesothelioma. Currently, it is not possible to accurately determine cancer stage prior to surgery or another treatment. This new method may allow doctors to better classify cancer stage and give a better estimate for prognosis prior to surgery or another treatment.

In this research study, the investigators would like to use biopsied tissue to study certain characteristics that will help test the new method for determining cancer stage and estimating prognosis.

In this research study, the investigators are...

* Obtaining pleural specimens at the time of routine diagnostic biopsy during the participant's standard treatment.
* Storing your biopsied tissue
* Studying the tissue to determine if the new method of staging and prognosis is accurate and valid

Eligibility criteria: Inclusion Criteria:

* All adult patients with a diagnosis of malignant pleural mesothelioma undergoing

  * diagnostic pleural biopsy
  * pleuroscopy
  * and/or VATS resections
* Participants must be 18 years of age or older.

Exclusion Criteria:

-Any patient who is found to be unsuitable for

* surgery,
* treatment
* diagnosis,

Primary outcomes:
measure: Pre-treatment Prognostic Algorithm Validation
timeFrame: 4 years
Secondary outcomes:
measure: Evaluation of Molecular Tests Base on RNA Expression
timeFrame: 4 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Raphael Bueno, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00204880: Aging and Cancer Effects (ACE) Study
Official title: Aging and Cancer: The Effects of Comorbidities on Cancer and it's Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lung Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 34
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women over the age of 55 newly diagnosed with lung, breast, colon or rectal cancer, and with an anticipated life expectancy of at least 2 years for breast cancer patients,1 year for patients with lung cancer, and 2 years for patients with colon or rectal cancer. There is no upper age limit for participation in this study.

Brief summary: Hypotheses:

1. Subjective self-reported data can be used to accurately reflect functioning across the 5 key domains.
2. Cancer and its various treatment modalities will exert detrimental effects on the 5 key domains in older adults with cancer.
3. Some aspect of baseline patient characteristic will be predictive of cancer-related outcomes.


Eligibility criteria: Inclusion Criteria:

* Willing to do memory testing
* Willing to participate in activities of daily living assessment
* Can use a cane or walker
* Willing to complete a balance performance assessment, if able.

Exclusion Criteria:

* Currently receiving treatment for cancer.
* Has a previous history of brain cancer
* Significant neurological disease other than AD that might affect cognitive function, such as stroke, Parkinson's disease, multiple sclerosis, or serious traumatic brain injury.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Sanjay Asthana, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06404580: The Benefits of R Anastomotic Technique for Billroth-II Reconstruction With Braun Anastomosis During Totally Laparoscopic Distal Gastrectomy: a Propensity Score Matching Analysis
Official title: The Benefits of R Anastomotic Technique for Billroth-II Reconstruction With Braun Anastomosis During Totally Laparoscopic Distal Gastrectomy: a Propensity Score Matching Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: the Incidences of Clavien-Dindo Grade II or Higher
Anastomotic Time
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 246
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: between March 2019 and September 2022 at Northern Jiangsu people's hospital were prospectively collected, and data from patients who underwent conventional anastomosis (control group) were retrospectively collected from the same prospectively maintained database of patients who underwent TLDG between January 2010 and February 2019 at Northern Jiangsu people's hospital.

Brief summary: Between March 2019 and September 2022 in our centre, R anastomosis was performed on 123 patients undergoing TLDG for distal gastric cancer. A retrospective review of a prospectively collected database identified patients who underwent TLDG between January 2010 and September 2022. Patients who underwent R anastomosis were matched in a 1:1 ratio with patients who underwent conventional anastomosis using a propensity score based on age, sex, preoperative BMI, American Society of Anesthesiologists (ASA) score, and the history of abdominal surgery. Surgical and postoperative outcomes and clinicopathological data were analyzed for both groups.


Eligibility criteria: Inclusion Criteria:

1. elective surgery for endoscopic and pathological diagnosis of malignant tumour of the gastric antrum or body with no distant metastases confirmed by multilayer spiral computed tomography;
2. patients who underwent B-II-B anastomosis during TLDG; and (3) patients who could be followed up postoperatively.

Exclusion Criteria:

(1) patients who had received preoperative neoadjuvant radiotherapy or chemotherapy; (2) patients undergoing emergency surgery; (3) the presence of other malignant tumours concurrently; and (4) patients who were lost to follow-up.

Primary outcomes:
measure: the incidences of Clavien-Dindo grade II or higher
timeFrame: 2010-2022
measure: anastomotic time
timeFrame: 2010-2022
Secondary outcomes:
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT01053780: Effects of Remote Intercessory Prayer
Official title: Effects of Remote Intercessory Prayer in Outcomes of Pregnants Women: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Remote Intercessory Prayer
Keywords: Intercessory Prayer, pregnants
Lead sponsor: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Sponsor class: OTHER
First posted: 2010-01-21
Enrollment: 565
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intercessory prayer can improve the outcome of pregnancies?


Eligibility criteria: Inclusion Criteria:

* be pregnant, belong to the public health system

Exclusion Criteria:

* no consent to participate in the research

Primary outcomes:
measure: Apgar score
timeFrame: birth . The time to collect the outcome must be at least the tenth day after making randomization. If the birth occurs before the patient will be excluded from the study.
Secondary outcomes:
measure: type of delivery complications in childbirth
timeFrame: birth or abortion. There isn't a pre-determined time. Must be at least 9 days after randomization to allow time to be done the intervention (intercessory prayer)
Other outcomes:
Locations:
city: Criciúma
country: Brazil
facility: Maria Inês da Rosa
state: Santa Catarina
city: Criciúma
country: Brazil
facility: Universidade do Extremo Sul catarinense
state: Santa Catarina
city: Criciuma
country: Brazil
facility: Universidade do Extremo Sul Catarinense
state: SC
Study officials:
References:
Clinical trial NCT03701880: Early Use of Ivabradine in Heart Failure
Official title: The Impact of Ivabradine Administration on Clinical Outcome and Biomarkers of Decompensated Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Decompensated Heart Failure
Keywords: Decompensated Heart Failure
Ivabradine
ST2 Biomarker
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Sadat City University
First posted: 2018-10-10
Enrollment: 50
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 aim of the work is to Evaluate the efficacy, quality of life and safety of early addition of ivabradine to B-blocker in reduced EF heart failure patients after acute decompensation compared to the standard treatment.

Detailed description: this study is a Prospective randomized open label study will be conducted on Egyptian patient with heart failure with reduced ejection fraction(rEF HF). Each of the eligible patients will be randomized to one of these groups, early administration of Ivabradine and B-blocker group or control group which follows American Heart Association treatment guidelines of rEF HF.

The objectives include the following:

1. Physical examination (heart rate, blood pressure, dyspnea and orthopnea symptoms)
2. NYHA class
3. Pro-NT-BNP serum level, ST2 serum level
4. Echocardiography (left ventricular ejection fraction)
5. Score of Minnesota Living with Heart Failure Questionnaire these objectives will be measured baseline, 2 weeks and after 3 months

Eligibility criteria: Inclusion Criteria:

1. Patient with acute heart failure either newly diagnosed or decompensated heart failure after stabilization
2. Patients \> 18 years old
3. Left ventricular ejection fraction less than 40 % of presumed irreversible etiology
4. Clinically stable 24-48 hours after admission
5. Sinus rhythm with heart rate above 70 bpm
6. No previous treatment with ivabradine

Exclusion Criteria:

1. Patients less than 18 years.
2. Arterial fibrillation before inclusion.
3. Ventricular dysfunction due to acute event (Myocarditis, AMI). 4- cardiogenic shock

5. Patients are taking drug interact with ivabradine. 6- carrier or candidate for pacemaker, heart transportation, cardiac surgery or other cardiovascular procedure

Primary outcomes:
measure: serum Pro-BNP level
timeFrame: 3 months
Secondary outcomes:
measure: ST2 serum level
timeFrame: 3 months
measure: The effect on patient quality of life using Minnesota Living with Heart Failure Questionnaire
timeFrame: 3 months of follow-up.
measure: NYHA class assessment
timeFrame: 3 months
measure: Heart rate
timeFrame: 3 months
measure: Left ventricular ejection fraction assessment
timeFrame: 3 months
measure: Blood pressure
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: El Demerdash Hospital
Study officials:
References:
Clinical trial NCT04215380: Effects of Gum Arabic Ingestion on Hormonal and Metabolic Changes in Patients With Polycystic Ovary Syndrome
Official title: Effects of Gum Arabic Ingestion on Hormonal and Metabolic Changes in Patients With Polycystic Ovary Syndrome: Two Arm Randomized Double Blind Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Al-Neelain University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effects on hormonal and metabolic changes in the PCOs patients after ingestion of Arabic gum

Detailed description: Polycystic ovary syndrome (PCOS) affects 5-20% of women of reproductive age worldwide it increases the risk for type 2 diabetes mellitus, cerebrovascular and cardiovascular events and not to mention it is one of the main causes of infertility. in the management of PCOS life style modification like weight reduction is necessary and recently it was discovered that GA ingestion causes significant reduction in BMI and body fat percentage among healthy adult females.so if GA could also affect the hormones and the metabolic changes in PCOs is going to be useful in decreasing the comorbidities and even treating PCOs.

Eligibility criteria: Inclusion Criteria:

* Patients who are diagnosed with PCO by independent Gynecologist

Exclusion Criteria:

* Diabetic patients
* Menopausal women
* History of allergy to Gum Arabic

Primary outcomes:
measure: hormonal changes
timeFrame: 12 weeks
Secondary outcomes:
measure: Metabolic change Serum cholestrol
timeFrame: 12 weeks
measure: Metabolic change HBA1C
timeFrame: 12 weeks
measure: Body Mass index
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Khartoum
country: Sudan
facility: Banoon center for assisted reproduction and, obstetrics and gynecology
Study officials:
affiliation: Alneelain University
name: Imad M Fdl-Elmula, PhD
role: STUDY_DIRECTOR
References:
citation: Babiker R, Elmusharaf K, Keogh MB, Saeed AM. Effect of Gum Arabic (Acacia Senegal) supplementation on visceral adiposity index (VAI) and blood pressure in patients with type 2 diabetes mellitus as indicators of cardiovascular disease (CVD): a randomized and placebo-controlled clinical trial. Lipids Health Dis. 2018 Mar 20;17(1):56. doi: 10.1186/s12944-018-0711-y.
citation: Esmaeilzadeh S, Andarieh MG, Ghadimi R, Delavar MA. Body mass index and gonadotropin hormones (LH & FSH) associate with clinical symptoms among women with polycystic ovary syndrome. Glob J Health Sci. 2014 Sep 28;7(2):101-6. doi: 10.5539/gjhs.v7n2p101.
citation: Kaddam L, Fadl-Elmula I, Eisawi OA, Abdelrazig HA, Saeed AM. Acacia Senegal (Gum Arabic) Supplementation Modulate Lipid Profile and Ameliorated Dyslipidemia among Sickle Cell Anemia Patients. J Lipids. 2019 Jun 18;2019:3129461. doi: 10.1155/2019/3129461. eCollection 2019.
Clinical trial NCT03453580: CT Portography in Grading of Liver Cirrhosis
Official title: Role of Multi Slice Computed Tomography Portography in Grading of Liver Cirrhosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CT Portography Grading of Liver Cirrhosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: liver cirrhosis

Brief summary: Esophageal variceal bleeding and hepatic encephalopathy are serious complications of hepatic cirrhosis, and they may lead to high mortality rate and severely threaten life quality of the patients

Detailed description: The occurrence and development of Esophageal variceal bleeding and hepatic encephalopathy are closely related with portal vein system diseases, such as collateral circulation of portal hypertension and portal vein thrombosis.

The prevention of Esophageal variceal bleeding and hepatic encephalopathy in hepatic cirrhosis has become a hot spot in clinical practice.

Three-dimensional reconstruction of images obtained by multi-slice spiral computed tomography portography (MSCTP) is clear, realistic, and accurate.

It can directly and quickly display all anatomical information of collateral portal vein system, and is recognized as a good method to display blood vessels

Eligibility criteria: Inclusion Criteria:

* Patients with cirrhosis and\\or portal hypertension diagnosed by; laboratory or radiological parameters.

Exclusion Criteria:

* Patients with ligation, disconnection or shunting of esophageal varices. Patients with combined hepatic malignant tumor Patients with splenectomy. Patients with renal dysfunction or iodine allergy.

Primary outcomes:
measure: Grading of liver cirrhosis
timeFrame: 15 min
Secondary outcomes:
measure: prediction of esophageal varices and hepatic encephalopathy
timeFrame: 20 min
Other outcomes:
Locations:
Study officials:
References:
citation: Biecker E. Gastrointestinal Bleeding in Cirrhotic Patients with Portal Hypertension. ISRN Hepatol. 2013 Jul 22;2013:541836. doi: 10.1155/2013/541836. eCollection 2013.
citation: Bajaj JS. Review article: potential mechanisms of action of rifaximin in the management of hepatic encephalopathy and other complications of cirrhosis. Aliment Pharmacol Ther. 2016 Jan;43 Suppl 1:11-26. doi: 10.1111/apt.13435.
citation: Chu Q, Li Z, Zhang SM, Hu DY, Xiao M. Relationship between encephalopathy and portal vein-vena cava shunt: value of computed tomography during arterial portography. World J Gastroenterol. 2004 Jul 1;10(13):1939-42. doi: 10.3748/wjg.v10.i13.1939.
Clinical trial NCT03801980: Phase 3 Study of SK-1403
Official title: Phase 3 Study of SK-1403 ; Double-blinded Parallel Group in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Secondary Hyperparathyroidism
Lead sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-01-14
Enrollment: 153
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of treatment with SK-1403 for 24 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Serum PTH\>240 pg/mL at the screening
* Serum corrected Ca≧8.4 mg/dL at the screening
* Stable chronic kidney disease patients who undergo hemodialysis or hemodialysis filtration

Exclusion Criteria:

* Primary hyperparathyroidism
* Severe liver disease
* Severe Cardiac disease
* History or family history of long QT syndrome
* Malignant tumor
* Uncontrolled diabetes mellitus
* Uncontrolled hypertension
* History of severe drug allergy

Primary outcomes:
measure: Rate of participants who achieved a mean serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL from 22 to 24 week.
timeFrame: 24 weeks
Secondary outcomes:
measure: Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point.
timeFrame: 24 weeks
measure: Measured values and Changes from baseline in serum PTH
timeFrame: 24 weeks
measure: Measured values and Changes from baseline in Ca
timeFrame: 24 weeks
measure: Measured values and Changes from baseline in ionized Ca
timeFrame: 24 weeks
measure: Measured values and Changes from baseline in P
timeFrame: 24 weeks
measure: Measured values and Changes from baseline in serum Ca x P product
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Investigational site (there may be other sites in this country)
Study officials:
References:
Clinical trial NCT05614180: Chronic Total Occlusive Lesions CMR Study
Official title: Chronic Total Occlusive Lesions CMR Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Total Occlusion
Image
Revascularization
Keywords: Chronic Total Occlusion
Cardiac magnetic resonance
Revascularization
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population includes patients presenting with a diagnose of coronary chronic total occlusions undergoing percutaneous coronary intervention.

Brief summary: This registry will include consecutive patients presenting with at least one chronic total occlusion on coronary angiogram who will be treated by percutaneous coronary intervention in our center. All patients will undergo a non-invasive assessment for myocardial ischemia/viability using cardiac magnetic resonance (CMR) prior to revascularization therapy. Follow up CMR will be repeated in all participants after three months and one year. Additionally, clinical outcomes and quality of life will be evaluated at baseline and at follow-up. Primary objective of this study is to investigate the the reduction in ischemia (as evaluated by follow-up CMR) and the severity of angina according to clinical evaluation (including Seattle Angina Questionnaires \[SAQ\], Canadian Class Score\[CCS\] and 6-mins walking test).


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Presence of at least one untreated CTO at basal angiography (defined as a total occlusion in any major coronary vessel or relevant side branches \[reference vessel diameter ≥2.5mm or as judged by two independent interventional cardiologists\], with TIMI 0 in the distal segment and at least 3 months old
* Patient has a clinical indication to perform CTO PCI
* Willing to participate and able to understand, read and sign the informed consent document.

Exclusion Criteria:

* CMR contraindications
* Contraindications to adenosine or dobutamine
* Severe chronic kidney disease (estimated Glomerular Filtration Rate \[eGFR\] \<60 mL/min/1.73m2 or serum creatinine level \>2.5 mg/dL)

Primary outcomes:
measure: Change in ischemia
timeFrame: 3 months; 12 months
Secondary outcomes:
measure: Rate of target lesion failure (TLF).
timeFrame: 12 months
measure: Changes in angina paramteres
timeFrame: 3 months; 12 months
measure: Change of left ventricular structure and function
timeFrame: 3 months; 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing anzhen hospital
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Lin Zhao, MD
role: PRINCIPAL_INVESTIGATOR
References: