cyrilzakka/clinical-trials huggingface dataset:
Prospective Observational Multicenter Study of Patients With AH and CKD Markers in Kazakhstan (PROGRESS-CKD)

Multicenter, non-interventional PRospective Observational study with retrospective analysis to describe the rate of CKD diaGnosis in patients with aRtErial hypErtenSion and CKD markerS in Kazakhstan

Primary endpoints:

The proportion of patients with markers of chronic kidney disease (CKD) among patients with arterial hypertension such as: albuminuria/proteinuria; GFR \<60 ml/min/1.73 m2 (CFR categories C3a-C5).

Secondary endpoints:

The following secondary endpoints will be evaluated in all patients with AH and markers of CKD included in the study (Full Analysis Sampling - FAS) (Secondary Aim 1) and in the subgroup of patients with a diagnosis of CKD confirmed during the study (Modified Full Analysis Sampling - mFAS), i.e., at Visit 1 or

Visit 2 (Secondary Aim 2):

Eligibility Criteria:
Inclusion Criteria:

Age ≥18 years at the time of inclusion;

* Patient signed and dated written informed consent form (ICF) in accordance with ICH GCP and local legislation prior to inclusion in the study for the prospective observational cohort;
* Established diagnosis of hypertension, diagnosed in accordance with current clinical guidelines for hypertension, i.e. in adults, i.e. systolic blood pressure (SBP) ≥140 mmHg and/or diastolic blood pressure (DBP) ≥90 mmHg. when measured at two different visits
* Laboratory markers of CKD (eGFR \<60 mL/min/1.73 m2 and/or albuminuria/proteinuria\*) measured during the period ≥3 and ≤12 months prior to inclusion in the study without a recorded diagnosis of CKD in the primary medical record prior to inclusion;

  \* any of the following: urine albumin/creatinine ratio (UACR) ≥30 mg/g (3 mg/mmol), urine total protein(protein)/creatinine ratio ≥150 mg/g (15 mg/mmol), albuminuria ≥30 mg/d or proteinuria ≥0.15 mg/d.
* Absence of documented diagnosis of CKD in the patient's medical records prior to inclusion in the study

Exclusion Criteria:

* Absence of a signed ICF in patients in the prospective follow-up group

  * Participation in any randomized controlled trial within 3 months prior to inclusion in this study or during participation in this study
  * An established diagnosis of type 1 or type 2 diabetes mellitus.
  * Diagnosis of symptomatic chronic heart failure (CHF), NYHA functional class III-IV, documented in the patient's medical records
  * Diagnosis of AH of secondary genesis
Evaluation of Losartan and Perindopril in Blacks Type 2 Diabetics Patients

The aim of this study is to compare the short-term effects of ACEi and angiotensin II receptor blockers on cardiac and renal protection in black type 2 diabetics patients CARE-PLP is a double-arm, double-blind, randomized and parallel clinical trial conducted at the National Obesity Center in the Yaoundé Central Hospital. A population of Type 2 diabetes patients, with hypertension and / or microalbuminuria and who are not taking ACEi or angiotensin receptors blockers, is randomize into two groups. Depending on the group, 10 mg Perindopril or 100 mg Losartan is add to the usual treatment for each patient. The patients are followed-up for a period of 08 weeks. The primary outcome is the variation of exercise induced urinary albumin excretion after 08 weeks of intervention.

Given the particularity of the renin-angiotensin system in black subjects, the CARE-PLP study fulfills this objective with the comparison of Losartan and Perindopril after 08 weeks of administration in a subsaharan African population.

Aim: The aim of this study is to compare the short-term effects of ACEi and angiotensin II receptor blockers on cardiac and renal protection in black type 2 diabetics patients

Methods: CARE-PLP is a double-arm, double-blind, randomized and parallel clinical trial conducted at the National Obesity Center in the Yaoundé Central Hospital. A population of Type 2 diabetes patients, with hypertension and / or microalbuminuria and who are not taking ACEi or angiotensin receptors blockers, is randomize into two groups. Depending on the group, 10 mg Perindopril or 100 mg Losartan is add to the usual treatment for each patient. The patients are followed-up for a period of 08 weeks. The primary outcome is the variation of exercise induced urinary albumin excretion after 08 weeks of intervention.

Progress: Recruitment for CARE-PLP was completed in february 2018 with 29 patients.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetics subjects
* Urinary albumin excretion \>30 g/day or Blood pressure \> 140/90
* On a stable antidiabetic and antihypertensive therapies (determined by the investigator) for at least 3 months with no classes changes. The pharmacological treatment should not include an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker
* Subject must not present any contraindication to exercise
* Before any study-specific procedure, the appropriate written informed consent must be obtained.

Exclusion Criteria:

* Side effects affecting life quality of patients (determined by the Data Safety Monitoring Board).
* Signs of exercise intolerance
* Out of sight.
* Withdrawal of consent
Evaluate Women After Vaginal Surgery for Urinary Symptoms and Sexual Function

Assess the outcomes of vaginal surgeries and its impact on sexual function and urinary symptoms.

Currently, up to 43% of women in the United States have female sexual dysfunction (FSD). In a recent study of 109 sexually active women in a urogynecology practice, FSD was noted using the validated Female Sexual Function Index (FSFI) in 64% of the women. Difficulties with sexual function are also associated with pelvic organ prolapse and urinary incontinence. One in nine women will have surgery for incontinence or prolapse in her lifetime. The impact of vaginal surgeries on sexual function and urinary symptoms has been scarcely reported in the literature. The methodology of most of those studies is flawed by the use of questionnaires that were not validated, small sample sizes and no comparison control group. In addition, several studies only focused on one surgical intervention, specific types of incontinence or prolapse, or both. It is difficult to make sense out of the discordant research findings when applying it to our patient population.

This is a prospective study of women with incontinence or pelvic organ prolapse. Subjects will be selected from three urology practices. All patients will be asked to complete a short patient history form. If the woman meets the study criteria, the study will be explained and if she agrees to participate in this study, informed consent will be obtained. She will then complete the FSFI, SF-12 and PFDI-20 questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Women at least 18 years of age
* Having urinary incontinence or pelvic organ prolapse
* Capable of giving informed consent
* Capable and willing to follow all study related procedures

Exclusion Criteria:

* Reported history of urethral obstruction (not secondary to prolapse), stricture, bladder calculi or bladder tumor in the last 2 years.
* Pregnant as confirmed by urine pregnancy test or plans to become pregnant during the study period.
* Breast feeding
* Currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function
* Cannot independently comprehend and complete the questionnaires.
* The subject is deemed unsuitable for enrollment in this study by the investigators based on their history or physical examination.
Efficacy and Mechanism of TCCRP in Patients With Chronic Coronary Syndrome Under Fusion Cardiac Rehabilitation Model

This study is a prospective, multi-center, randomized controlled clinical study. It developed an innovative Tai Chi Cardiac Rehabilitation Program (TCCRP) for patients with chronic coronary syndrome (CCS) and evaluated the efficacy, acceptability and safety of TCCRP on patients with CCS in order to explore the possible mechanism of its feasibility.

This study is a prospective, multi-center, randomized controlled clinical trial of 100 participants with chronic coronary syndrome (CCS) that compares Tai Chi cardiac rehabilitation program (TCCRP) with conventional exercise rehabilitation programs (CERP), with an allocation ratio of 1:1. A total of 6 months study period, including 1 month in-hospital rehabilitation, 2 months home-based rehabilitation and 3 months follow-up. The main outcome indicators were measured at baseline, 1 month, 3 months and 6 months. The secondary outcome measures will be measured at baseline and at 3 months.

Eligibility Criteria:
Inclusion criteria

1. Male or non-pregnant women aged from 18 to 80 years;
2. Patients who met the stable angina pectoris in accordance with coronary heart disease;
3. NYHA class Ι, Π or Ш;
4. Participants were able to understand the purpose of clinical trials and voluntarily participate and sign informed consent.

Exclusion criteria

1. Acute myocardial infarction (AMI) within 2 weeks;
2. Severe aortic stenosis;
3. Hypertrophic cardiomyopathy;
4. Severe valvular heart disease;
5. Malignant tachyarrhythmia;
6. The patient compliance was poor and the clinical trial could not be completed according to the requirements.
7. Combined exercise can cause deterioration of the nervous system, motor system disease, or rheumatic disease.
8. In the past 3 months, those who regularly practice Tai Chi;
9. Patients with gastrointestinal diseases, infectious diseases, renal insufficiency, and a history of gastrointestinal surgery within one year
Two Bedside Ultrasound Techniques and Standard Methods for Confirmation of Endotracheal Tube Insertion in Intensive Care Patients

This cross-sectional observational study aims to predict the sensitivity and specificity of ultrasonography using suprasternal and subxiphoid methods to confirm the correct placement of endotracheal tubes compared to standard methods in intensive care patients.

Endotracheal intubation is the primary medical procedure used for securing the airway, confirmation of endotracheal tube (ETT) placement is essential to prevent hypoxia and aspiration. The best primary approach to confirm endotracheal tube placement is observation of the tube passage through the vocal cords followed by assessment based on chest and epigastric auscultation.

Ultrasound machines are now increasingly available in emergency departments and intensive care units. It is a non-invasive, portable and serves as a real-time diagnostic tool with rapid and accurate results.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old.
* Both sex.
* All patients requiring prophylactic airway management e.g (patient with Glasgow Coma Scale \<8) with endotracheal intubation in the intensive care unit.

Exclusion Criteria:

* An abnormal airway anatomy.
* Tracheal or endobronchial lesion.
* Significant cervical trauma.
* Cervical abnormality.
* Neck swelling.
* Patients who need cardiopulmonary resuscitation.
Combined Cognitive Remediation and Behavioral Intervention for Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)

The objective of this study is to evaluate a novel sequenced combination of a promising, computerized cognitive training program targeting working memory (WM) deficits in children with attention-deficit/hyperactivity disorder (ADHD) in combination with behavioral parent training, a well-established, evidence-based intervention for ADHD.

The combined active intervention, compared to the combined control intervention will result in improvement in primary psychosocial (i.e., parent/teacher reported child impairment; parental stress; parenting behavior; and observed child academic achievement) and psychiatric (parent/teacher rated ADHD, ODD, and CD symptoms; observed activity level and attention) outcomes at post-treatment and follow up assessment, with the combined active intervention resulting in greater improvements in these outcomes.


Eligibility Criteria:
Inclusion Criteria:

- Diagnosis of ADHD Children 7-11 year olds English Speaking

Exclusion Criteria:

- Pervasive Developmental Disorder IQ\< 80
Thoracic Epidural for Postoperative Ileus

The investigators try to find whether thoracic epidural analgesia (TEA) shortens the first gas-out time compared to iv-PCA and promotes earlier discharge after major upper abdominal surgery.

Postoperative ileus (POI) is a prolonged inhibition of coordinated bowel activity after surgery. Half of patients undergoing major abdominal surgery experience POI making it one of the limiting factors for early recovery.

The pathogenesis of POI is multifactorial, and includes neurogenic, inflammatory and pharmacological mechanisms. Thoracic epidural analgesia (TEA) can induce sympathetic block, attenuate inflammatory reaction and limit use of systemic opioids. In addition, sympatholysis induced by TEA can improve microcirculation of bowels and parasympathetic activation can increase gastrointestinal motility.

However, studies comparing TEA and iv-PCA on POI are rare in major upper abdominal surgeries. This study, therefore, compares TEA and iv-PCA in terms of bowel function recovery as a primary endpoint in major upper abdominal surgeries. Secondary endpoints are side effects and hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists' (ASA) physical statusⅠ-Ⅲ

Exclusion Criteria:

* ASA status of Ⅳ, or more
* Body mass index 30 kg.m2-1 or more
* Severe renal, hepatic, or neurologic diseases
* Opioid or systemic analgesic preoperatively
Effect of Beta-Glucan on Cholesterol Lowering

The primary aim of this study is to determine whether the cholesterol-lowering efficacy of barley b- glucan varied as function of molecular weight (MW) and the total daily amount consumed. Our second aim is to investigate the mechanism responsible for the action, specifically, whether β-glucan lowers circulating cholesterol concentration via inhibiting cholesterol absorption and synthesis. Thirdly, we aim to determine if any gene-diet interactions are associated with cholesterol lowering by barley β-glucan. In addition, we aim to investigate the alteration of the gut microbiota after β-glucan consumption and the correlation between the altered gut microbiota and cardiovascular disease risk factors.

This study consists of four dietary phases which are separated by \>28 days wash-out period. During the treatment phase, participants will be provided with all meals for the 35 day period. Breakfast meals will be consumed under the supervision of the research staff and lunch, dinner and snacks will be provided to take home in take-out packaging. While subjects are on the wash-out period they will return to their normal diet. The meals are on a 7 day rotating schedule that reflect an average Canadian diet. Changes in blood lipids, body weight, and waist circumference will be measured during each treatment phase. Cholesterol absorption and synthesis will be examined by stable isotope method. Single nucleotide polymorphisms (SNPs), rs3808607 of gene CYP7A1and rs429358 and rs7412 will be determined byTaqMan® SNP Genotyping assay following the manufacturer's protocol. Fecal samples will be collected at the end of each intervention phase and will be subjected to Illumina sequencing of 16S rRNA genes.

Eligibility Criteria:
Inclusion Criteria:

* BMI 20-40 kg/m2
* Fasting cholesterol levels of 5.0-8.0 mmol/L
* Fasting serum LDL cholesterol levels of 2.7-5.0 mmol/L

Exclusion Criteria:

* Pregnant or lactating
* Taking lipid lowering medication or nutritional supplements that affect blood lipids
* Dietary restrictions which would affect consuming the study diet for 5-wk for four study phases.
* Not deemed healthy by study physician
Multicenter Study of Peritransplantation Immunosuppression for Mismatched Hematopoietic Cell Transplantation After Reduced Intensity Conditioning

Feasibility and toxicity of peritransplantation immunosuppression with ATG, sirolimus, mycophenolate mofetil and rituximab in patients receiving mismatched allogeneic HCT after a reduced intensity conditioning regimen with fludarabine/treosulfan


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for mismatched allogeneic HCT
* Unrelated donor with maximal 2 antigen or allelic mismatches in HLA-I or HLA-II
* Age \>=75, \>=18 years
* Patients Age \<=50 if a HCT-CI score \> 2 \[acc. to Sorror et al., 2005\]
* Karnofsky Index \>60%
* Patients with:

  * Acute myeloid leukemia in CR (\<5% blasts)
  * Acute lymphoblastic leukemia in CR (\< 5% blasts)
  * Myelodysplastic syndrome with up to 20% blasts
  * Osteomyelofibrosis
  * Chronic lymphocytic leukemia
  * High grade Non-Hodgkin Lymphoma in CR or PR
  * Low grad Non-Hodgkin Lymphoma in CR or PR
  * M. Hodgkin in CR or PR
  * Chronic myeloid leukaemia in chronic phase or CR of blast crisis

Exclusion Criteria:

* Patients with \>5% blasts in BM at the time of transplantation
* Progressive or chemorefractory disease
* Less than 3 months after preceding HCT
* CNS involvement with disease
* Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month.
* Liver function abnormalities with bilirubin \>2 mg/dL and elevation of transaminases higher 2x upper limit of normal.
* Chronic active viral hepatitis
* Ejection fraction \<40 % on echocardiography
* Patients with \> grade II hypertension by CTC criteria
* Creatinine clearance \<50 ml/min
* Proteinuria \>800 mg/24 h
* Respiratory failure necessitating supplemental oxygen or DLCO \<30%
* Allergy against murine antibodies
* Known allergy/intolerance against sirolimus or one of it's excipients
* HIV-Infection
* Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control during study treatment and for at least 12 months thereafter. (Women of childbearing potential must have a negative serum pregnancy test at study entry)
* Concurrent severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study
* Patients with a history of psychiatric illness or condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction)
* Patients unwilling or unable to comply with the protocol
* Unable to give informed consent
* Enrollment in an other trial interfering with the endpoints of this study
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children

The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy children.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged \>= 6 months to \< 9 years at the time of the first study vaccination.
* For children \< 3 years of age at the time of first vaccination, born at or after 36 weeks of gestation.

Exclusion Criteria:

* Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thiomersal, neomycin, polymyxin, or any components of the Study Vaccine.
Medication Reconciliation in Hospitalized CKD Patients : a Quasi-Experimental Study

This study aimed to evaluate the impact of combining medication reconciliation with medication review on reducing medication discrepancies at discharge and all-cause readmissions among CKD patients, in comparison to a retrospective control group that received usual care, which may or may not have included medication reconciliation.


Eligibility Criteria:
Inclusion Criteria:

Adult (18 years or older) admitted patients with CKD (stages 2-5 ), who were using at least three chronic medicines at home, and were hospitalized for at least 48 hours.

Exclusion Criteria:

Patients with kidney transplantation . Patients who have difficulties in responding to interviews and did not have family member or caregiver on behave, and those who refused to provide a written informed consent.
Bedside Ultrasound Measurement of the Inferior Vena Cava Correlates to Central Venous Pressure

This study proposes to examine the correlation of central venous pressure to measures of the diameter of the inferior vena cava as determined by bedside ultrasonography.

Central venous pressure (CVP) is a key physiologic estimate of preload, which in turn helps define the vascular fluid status. It is a particularly important parameter to measure in critically ill and injured patients who may require resuscitation. Unfortunately, measurement of the CVP requires invasive central venous catheters which can be difficult or time-consuming to insert. A non-invasive means of inferring the CVP would provide clinicians with an alternative. Preliminary data suggests that the diameter of the vena cava may reflect the CVP. Ultrasonography can provide reliable measures of internal body structures including the vena cava, and therefore may be useful in this regard. Collecting simultaneous values of vena cava diameter and CVPs will allow for the identification and quantification of correlation.

Eligibility Criteria:
Inclusion Criteria:

* CVP or right heart catheter that is already in place and functioning properly

Exclusion Criteria:

* Supine position or placement of ultrasound probe on abdomen is contraindicated.
Stereotactic Image-Guided Navigation During Breast Reconstruction in Patients With Breast Cancer

Many hospitals, including the Ohio State University Medical Center, will take pictures of the blood vessels in a patient's abdomen before they decide to perform a breast reconstruction using the patient's own tissue. These pictures are called computed tomography (CT) angiograms and are like a map of each patient's anatomy. However, no study has been reported that determined how accurate these pictures are at showing the surgeon where all of the blood vessels were located. This study will try to determine if these pictures are missing any blood vessels that are found during surgery and if the pictures show the correct location of the vessels

PRIMARY OBJECTIVES:

I. To analyze the accuracy of preoperative CT angiography in determining the location of perforator vessels. Through the use of an intraoperative navigation system, we will objectively locate perforators during surgery and compare the results to the preoperative imaging assessment of the flap's vascular anatomy.

II. To determine whether the preoperative CT angiogram allows the microsurgeon to correctly identify the perforators that are ultimately used as the pedicle for the flap.

OUTLINE:

Patients undergo deep inferior epigastric perforator (DIEP) flap breast reconstruction using the StealthStation navigation system.

After completion of study treatment, patients are followed up at 1-2 weeks and 1 month, then every 3 months for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed breast carcinoma or breast carcinoma in situ desiring unilateral or bilateral deep inferior epigastric perforator (DIEP) flap breast reconstruction
* Patients must be candidates for elective surgery, without clinically significant cardiac or pulmonary disease (New York Heart Association \[NYHA\] class III/IV), without infection requiring antibiotics, and without serious illness requiring the use of steroids
* Patients must have normal kidney function and no allergy to intravenous (IV) dye

Exclusion Criteria:

* Patients with previous abdominal donor site flaps will be excluded along with patients with previous extensive surgery to the anterior abdomen
* Patients with a weight of over 300 pounds or a body size not supported by the CT scanner will be excluded
* Patients who are expected to undergo postoperative radiation therapy will be excluded