cyrilzakka/clinical-trials huggingface dataset:
Vitamin D Supplementation for Treatment of Dyslipidemia

This study will be conducted to Assess possible reduction in lipid profile (LDL-Triglecerides-cholesterol) among pre-menopausal women in vit D group compared to standard treatment group after 3 months \& 6 month of follow up as prophylaxis step for atherosclerosis.

Vitamin D receptor gene mutations have been associated with increased incidence of arterial hypertension. While, hyperlipidemia and lipoprotein oxidation in bone is leading to osteoporosis by inhibiting osteoblastic differentiation It has been reported that vitamin D supplementation has shown pro-atherogenic effects in rats, and its deficiency is associated with the deterioration of atherogenesis These contradictory findings on the progression of atherosclerosis were examined in this study.

Aim: This study will be conducted to assess possible reduction in lipid profile (LDL-Triglycerides-cholesterol) among pre-menopausal women in vitamin D group compared to standard treatment group after 3 months \& 6 month of follow up as prophylaxis step for atherosclerosis.

Subject and methods: Randomized clinical trial with double blinding will be performed on two groups study group and control group. The cases will recruited from outpatient clinic of medicine department in Mansoura university Hospital.

Sample size: based on pilot study after start of trial

Study groups:

Intervention group: High dose vitamin D3 IM treatment group according to vitamin D3 level after laboratory assessment.

Standard treatment group: Balanced diet mix of Carbohydrate, lipid, protein and fat diet minerals and vitamins for same period of follow up.

Inclusion criteria : pre-menopausal females (35-45 years old)

* No co morbidity
* Negative history of contraceptive pills or drug history of cholesterol lowering drugs
* Absent chronic diseases

There is possible recruiting of postmenopausal women according to difficulty in finding pre-menopausal women.

Methods: study patients will be subjected to:

* Full history taking,clinical examination, Anthropometric measurements.
* Laboratory investigations: Vitamin D3 assessment for all study patients.

Outcome that will be measured before and after follow up:

1. Serum 25 hydroxy Vitamin D3
2. C reactive protein
3. Serum Calcium level
4. Complete Lipid profile: LDL-HDL-Triglycerides -Total cholesterol quantitative and qualitative assessment.Patient will be fasting for at least 12-14 h then 5 mL venous blood sample will be drawn from each patient into plain tube and left to clot. Serum for routine analysis and the other aliquot will be stored at -21°C analysis will be separated by centrifugation into two aliquots; one will be used

Eligibility Criteria:
Inclusion Criteria:

* premenopausal females (35-45 years)

Exclusion Criteria:

* no co morbodity
* no lipid lowering drugs or contraceptive pills
The Effect of Motivational Interviewing and Education Based on Watson's Theory of Human Caring in Hemodialysis

* Motivational interviewing and education based on Watson's Theory of Human Caring have an effect on increasing adherence to fluid intake in individuals receiving hemodialysis treatment.
* Motivational interviewing and education based on Watson's Theory of Human Caring have an effect on increasing adherence to diet in individuals receiving hemodialysis treatment.
* Motivational interviewing and education based on Watson's Theory of Human Caring have an effect on increasing adherence to drug management in individuals receiving hemodialysis treatment.
* Intervention group who receiving Motivational interviewing and education based on Watson's Theory of Human Caring would satisfied with introduced intervention.
* Motivational interviewing and education based on Watson's Theory of Human Caring have an effect on increasing quality of life in individuals receiving hemodialysis treatment.

The intervention group received 15 minute motivational interviewing based on Watson's Theory of Human Caring once a month for 12 weeks and one session 30 minutes education with educational booklet based on Watson's Theory of Human Caring. The control group received usual care. Adherence to fluid intake, diet and drug management, physical parameters and quality of life was measured at baseline and 12th week. The patient satisfaction was measured in the intervention group at 12th week.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were receive hemodialysis at Hemodialysis Unit of University Hospital in Antalya, Turkey
* Patients who had 1 and above from Diet And Fluid Non-Adherence Questionnaire total score
* Patients who had 0 or 1 score from 1.2. and 6. questions or 3., 4. and 5. questions in the Modified Morisky Scale.
* Patients who receiving Hemodialysis treatment for at least 3 months
* Patients who were over 18 years of age,
* Patients who had orientation of individual, place and time
* Patients who were literate
* Patients who no barriers to written or verbal communication
* Patients who agree to participate in the study

Exclusion Criteria:

* Patients who had psychiatric disease
* Patients who had diagnosis of malignancy
Incidence of Metal Failure During First Year Following Transpedicular Screws Fixation of Dorsolumbar Spine Fracture

Recording incidence of metal failure in transpedicular screws fixation of dorsal umbra spine fracture during first year follow up


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* post traumatic dorsolumbar spine fracture fixed with short or long segment transpedicular screws
* With or without decompression

Exclusion Criteria:

* pediatric patients
* Pathological fractures
Breast Cancer Risk in Women Who Are BRCA1/BRCA2 Mutation Carriers

This research study is looking at breast cancer risk in women who are BRCA1/BRCA2 mutation carriers. Studying samples of DNA in the laboratory from women who are BRCA1/BRCA2 mutation carriers may help doctors identify biomarkers related to cancer.

OBJECTIVE:

I. To identify potential genetic modifiers of breast cancer risk in women who are carriers of the breast cancer susceptibility genes, BRCA1/2, by collecting data and genetic information from GOG-0199 and contributing it to the Consortium of Investigators of Modifiers of BRCA-Associated Breast Cancer (CIMBA), an international consortium of clinical cancer genetics investigators.

OUTLINE: This is a multicenter study. Patients are stratified by study, country of residence, ethnicity, and birth cohort. Joint analyses of BRCA1 and BRCA2 mutation carriers are further stratified by mutation.

Previously collected DNA samples and associated clinical information obtained from BRCA mutation-positive participants enrolled on GOG-0199 are studied. DNA samples are analyzed by mutation testing for variants (i.e., single nucleotide polymorphisms \[SNPs\]) in candidate genes of interest. Once genetic testing for a given set of variants has been completed, the coded laboratory data file is merged with selected demographic, clinical, and epidemiological data obtained from the GOG-0199 baseline questionnaire and submitted to the Consortium of Investigators of Modifiers of BRCA-Associated Breast Cancer (CIMBA) Central Database to analyze and publish the data. The epidemiological and SNP data contributed to the central database are then distributed to the investigators responsible for analysis of a particular SNP or set of SNPs from a candidate gene or genetic pathway.

Eligibility Criteria:
Inclusion Criteria:

* Women with or without a personal history of breast cancer prior to enrollment in Gynecologic Oncology Group (GOG)-0199

  * Known currently to be BRCA1/2 mutation carrier either by confirmed outside report or by research testing

    * No BRCA1/2 mutation-negative or mutation-unknown status
* Enrolled on clinical trial GOG-0199 AND meets the following criteria:

  * Completed baseline questionnaire (BQ-199)
  * Provided information on previous breast cancer history, including date of diagnosis
  * Provided complete data from the DNA analysis on the genetic variants of interest
* Available DNA samples for analysis
* Hormone receptor status not specified
* Pre- or post-menopausal status
Comparison of Innovative Rehabilitation Treatments and Examination of Their Effectiveness in Stroke Patients

We perform a comparison of several groups. We would like to determine how robotic and virtual therapy is most effective in the treatment of stroke patients. We place great emphasis on walking speed, quality of life, coordination and changes in walking distance.


Eligibility Criteria:
Inclusion Criteria:

post stroke 6MWT : 120\> minimum after stroke 3 days be a stroke patient first stroke hemiplegia

Exclusion Criteria:

multiple strokes, inability to stand and walk, cognitive function disorder does not reach 50 meters with a minimal walking aid Alcohol Sever heart problem sever demeanor alcoholism drug problems Drug
Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia-CP Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial

The purpose of this study is to assess whether dasatinib can be discontinued without occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in complete molecular remission (CMR) while on dasatinib.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Myeloid Leukemia in the Chronic Phase.
* Patients with BCR-ABL-negative checks.
* 15 years old over.
* ECOG performance status (PS) score 0-2.
* Adequate organ function (hepatic, renal and lung).
* Signed written informed consent.

Exclusion Criteria:

* A case with the double cancer of the activity.
* Women who are pregnant or breastfeeding.
* Patients with complications or a history of severe.
* Patients with mutation of T315I、F317L、V299L.
* Patients with additional chromosome abnormalities.
* The case of Pleural effusion with poor control.
* Patients with a history of hematopoietic stem cell transplantation.
Patient-reported Outcome Measures After Post-anesthesia Care Unit Delirium

To assess self-reported cognitive function and health-related quality of life in patients with and without early postoperative delirium

Neurocognitive disorders including postoperative delirium are a serious complication after surgery and anesthesia in the elderly. Postoperative delirium is an acute-onset diffuse brain dysfunction that is characterized by a fluctuating course of confusion, disorganized thinking, inattention, irritability, disturbances of the circadian rhythm, and disorders of consciousness. Post-anesthesia care unit (PACU) delirium occurs immediately after emergence from anesthesia and affects up to 45% of patients after elective surgery.

It is unclear, whether PACU delirium is associated with intermediated or long-term adverse outcomes including neurocognitive disorders or mortality. The aim of this prospective observational was to assess self-reported cognitive function and health-related quality of life in patients with and without PACU delirium three months after radical prostatectomy.

Eligibility Criteria:
Inclusion Criteria:

* elective radical prostatectomy
* \>60 years
* fluent in German

Exclusion Criteria:

* preexisting cognitive impairment
* cerebrovascular disease
Evaluation of Different Anchorage-supported Appliances and Expansion Procedures for Face Mask Treatment

The purpose of this study is to assess and compare the effect of two appliances (Hybrid-Hyrax expander/ Bonded rapid maxillary expander (RME)) supported by different anchorage units and two different expansion procedures (routine rapid maxillary expansion protocol (routine)/ alternative rapid expansion and constriction protocol (alt-RAMEC)) on maxillary protraction during face mask (FM) treatment.

Face mask therapy is an effective method in the treatment of class III malocclusions due to maxillary insufficiency. In face mask treatment, various intraoral devices are used to transmit protraction forces to the maxilla. According to the anchorage unit, these appliances are divided into tooth-supported and bone-supported. The traditional bonded rapid maxillary expander (RME) is a tooth-supported appliance that allows expansion and is generally used with face masks. However, it causes many side effects due to the transmission of protraction forces through the teeth. Hybrid appliances supported by skeletal and dental anchorage may be preferred over bonded RME in the maxilla for face mask treatment based on their lower dental side effects and high skeletal contribution.

Before transferring the protraction forces to the maxilla using a face mask, expansion is first performed with intraoral devices according to the patient's needs. For this purpose, two different expansion procedures are currently used: routine rapid maxillary expansion (routine) and alternative rapid maxillary expansion and contraction (alt-RAMEC). In the routine rapid maxillary expansion procedure, the expander screw is turned twice a day until the expansion phase is complete. Unlike the routine procedure, in the alt-RAMEC procedure, each week of expansion is followed by a week of contraction. The duration of the expansion-contraction process varies between 7-9 weeks, depending on the patient's need for expansion. These opening and closing phases are increased maxillary protraction by loosening the intermaxillary sutures.

The main purpose of this study is to compare the effects of different combinations of appliances and procedures on maxillary protraction during face mask treatment and determine the most powerful method. Sixty patients who were planned to apply face mask treatment were included in the study and divided into four groups (n=15) (Group 1: Hybrid-Hyrax expander and alt-RAMEC procedure, Group 2: Bonded RME and alt-RAMEC procedure, group 3: Hybrid Hyrax expander and routine protocol, group 4: Bonded RME and routine protocol). To investigate skeletal changes, lateral cephalometric films were taken before (T0) and after (T1) treatment. Dolphin Imaging software and AutoCad 2023 software were used for cephalometric measurements.

Eligibility Criteria:
Inclusion Criteria:

* Skeletal class III
* Prepubertal growth stage
* Reverse overjet

Exclusion Criteria:

* Previous orthodontic treatment history
* Patients with craniofacial abnormalities and syndromes.
* Systemic diseases
Registry in Patients With Aorto-iliac or Iliac Aneurysms

The PLIANT II registry is undertaken to examine the real-world outcome after treatment of consecutive patients with uni- or bilateral aorto-iliac or iliac aneurysms using the E-liac Stent Graft System.

In this study, patients will be observed who receive one or two E-liac Stent Graft(s) for aorto-iliac or iliac aneurysms. The E-liac Stent Graft(s) will be implanted at the discretion of the treating physician. Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the E-liac Stent Graft System. Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before intervention and before data are being collected.

The period of data collection will be 60 months starting from the intervention for each patient. 100% verification of patient informed consent and essential study documents will be performed at each study site. 60% of patient´s source documentation will be randomly monitored.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 85 years
* Patient must have an aorto-iliac or iliac aneurysm
* Patient must have a unilateral or bilateral iliac aneurysm
* Patient´s anatomy must be suitable for stent graft placement on preoperative angio CT scan
* Patient must be available for the appropriate follow-up times for the duration of the study
* Patient has been informed of the nature of the study, agrees to its provisions and has signed the informed consent form prior to intervention

Exclusion Criteria:

* Female of child bearing potential
* Patients with ruptured iliac aneurysms
* Patients with juxtarenal, pararenal or suprarenal aneurysms
* Patients pretreated with Nellix (Endologix) or Altura (Lombard Medical)
* Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
* Patient with malignancy needing chemotherapy or radiation
* Patients with life expectancy of less than 3 years
* Patient minor or under guardianship
Survey on Patient and Parental Perceptions of EEG-monitoring During Paediatric Anaesthesia Care

Electroencephalographic (EEG) monitoring during general anaesthesia (GA) is not typically part of standard care during GA. The recent availability of non-invasive commercial EEG monitors for children has made EEG monitoring more popular. Several studies have shown that monitoring EEG while under GA allows customization and titration of GA. However, the usefulness of EEG monitoring in children have not been established. It is a relatively new technology for some and will involve additional costs. The investigators aim to understand the perceptions of participants regarding EEG monitoring during paediatric anaesthesia care by administering a survey before and after GA.


Eligibility Criteria:
Inclusion Criteria:

* All parents of children 1-16 years old and patients 12-16 years old coming for elective surgery requiring GA at KK Women's and Children's Hospital will be invited to voluntarily participate in an electronic survey on Form SG.

Exclusion Criteria:

* Parents and patients coming for emergency surgery will not be invited for the survey.
Long-Term Safety Study of TAK-438 in the Maintenance Treatment of Healed Erosive Esophagitis

The purpose of this study is to determine the safety of long term use of TAK-438, once daily (QD), for the maintenance treatment of healed erosive esophagitis.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must have successfully completed the preceding phase 3 double-blind study (TAK-438/CCT-002: preceding study) and have endoscopically healed EE at Week 2, 4, or 8 in the preceding study.\*

   \* "Endoscopically healed EE" is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the Los Angeles (LA) Classification Grading System.
2. Outpatient (including inpatient for examination)

Exclusion Criteria:

1. Participants with an esophagus-related complication (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal stenosis, etc.), a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) or Barrett's esophagus are allowed to be included.
2. Participants who have received surgery or treatment affecting gastroesophageal reflux (cardioplasty, dilation of esophageal stenosis \[excluding Schatzki's ring\], etc.), or who have a history of surgery of stomach or duodenum (excluding removal of benign polyp under endoscopy)
3. Participants who have acute upper gastrointestinal bleeding, gastric or duodenal ulcer (mucosal defect with white coating) within 30 days prior to Visit M-1 (initiation of study drug administration). However, participants with gastric or duodenal erosions are allowed to be included.
4. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorder
Early Management Strategies of Acute Heart Failure for Patients With NSTEMI

There are always poor outcomes in patients with acute myocardial infarction(AMI) combined with elevated BNP/NT-proBNP level. An elevated BNP/NT-proBNP level highly indicates acute heart failure(AHF).Levosimendan is recommended in many clinical trials of heart failure and Chinese heart failure guidelines. As a result, the investigators form a hypothesis that when patients with AMI combined with elevated BNP/NT-proBNP level are in conditions before AHF, to use levosimendan may reduces the risk of heart failure and improve the outcome.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with NSTEMI in outpatient service or admitted to hospital;
2. Patients with an elevated NT-proBNP level;
3. Patients sign the informed consent;

Exclusion Criteria:

1. Patients with hypotension(systolic pressure\<100mmHg), creatinine clearance rate\<30ml/min or be allergic to levosimendan;
2. Patients whose heart function grade of Killip are Level III\~IV;
3. Patients suffering from hepatic failure, renal failure or other diseases which may shorten the lifetime to 6 months(for example tumor);
4. Patients with valvular heart diseases influencing haemodynamics, hypertrophic or restricted cardiomyopathy, constrictive pericarditis, severe pulmonary hypertension or myocarditis;
5. Patients with serum potassium level\<3.5mmol/L;
6. Pregnant and lactating women;
7. Patients participating in other relevant clinical studies.
Study to Evaluate the Safety and Efficacy of IV Infusion Treatment With Omecamtiv Mecarbil in Subjects With Left Ventricular Systolic Dysfunction Hospitalized for Acute Heart Failure (ATOMIC-AHF)

The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV) omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure. This is a multicenter, randomized, double-blind, placebo-controlled study with 3 dose cohorts enrolled sequentially in order of ascending dose strength of omecamtiv mecarbil. In each cohort, subjects are randomized 1:1 to omecamtiv mecarbil or placebo.

This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 - 85 years
* Hospitalized for worsening heart failure, within 24 hours of initiating IV loop diuretic
* Dyspnea due to heart failure, at rest or with minimal exertion
* History of left ventricular ejection fraction (LVEF) ≤ 40%
* Elevated brain natriuretic peptide (BNP) or N-terminal fragment BNP (NT-proBNP)

Exclusion Criteria:

* Receiving IV vasopressor (excluding low dopamine), inotropic or mechanical support
* Acute coronary syndrome (ACS)
* Within 30 days prior to enrollment: cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD) implantation, ACS, coronary revascularization, transient ischemic attack (TIA) or stroke, sustained ventricular arrhythmia, or major surgery
* Severe valvular stenosis, hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease
* Estimated glomerular filtration rate (eGFR) \< 20 mL/min/1.73m2