cyrilzakka/clinical-trials huggingface dataset:
A Physical Activity Intervention to Promote Cognitive Health, Cardiovascular Health and Sleep in Older Latinos

This study is a randomized, single-blind, controlled trial that will test a multilevel intervention, Tiempo Juntos para la Salud, (Time Together for Health) designed to promote moderate-intensity physical activity; theoretically grounded mediators; and secondary outcomes of cardiovascular health, sleep and cognitive function. Participants will have 4 visits over a year long period. Data collection will occur at baseline, 3 months, 6 months, and 12 months among 216 Spanish language-dominant Latinos aged 55 and older with Mild Cognitive Impairment (MCI) \[Montreal Cognitive Assessment (MoCA) score 23 to 26 for Latino populations\].


Eligibility Criteria:
Inclusion Criteria:

* Can provide informed consent
* 55+ years
* Self-identify as Hispanic/Latino
* Spanish as primary language
* Willing to attend intervention / education sessions
* Access to phone/cell
* less than 150 min of activity / week (sedentary)
* Montreal Cognitive Assessment (MoCA) score (score ≥ 23 to 26 for Latino populations)

Exclusion Criteria:

* Cannot provide informed consent
* Mobility disability
* Musculoskeletal problem / co-morbidity (prevents moderate PA)
Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS

Polycystic Ovary Syndrome (PCOS) is associated with hyperandrogenism, hyperinsulinemia and insulin resistance starting in the perimenarchal period. Insulin resistance also increases the risk of developing glucose intolerance, type 2 diabetes, hypertension, dyslipidemia and cardiovascular disorders. Studies on adult women with PCOS show that their aerobic capacity is affected. Therefore, in this study; it was aimed to compare the physical and cardiovascular fitness levels of adolescent PCOS patients with healthy adolescents.

Polycystic Ovary Syndrome (PCOS) is associated with hyperandrogenism, hyperinsulinemia and insulin resistance starting in the perimenarchal period. Insulin resistance also increases the risk of developing glucose intolerance, type 2 diabetes, hypertension, dyslipidemia and cardiovascular disorders. Studies on adult women with PCOS show that their aerobic capacity is affected. Therefore, in this study; it was aimed to compare the physical and cardiovascular fitness levels of adolescent PCOS patients with healthy adolescents.Total fat and muscle ratios will be measured with the bioelectrical impedance test (BIA) instrument for body composition evaluation of individuals in both groups. Body mass index (BMI), waist/hip and waist/height ratios will be recorded. The level of cardiovascular fitness will be evaluated with the PACER test, which is among the Fitness Gram Test Protocol. For physical fitness level, muscular strength parameter will be evaluated with hand dynamometer and knee extensor muscle strength, and muscular endurance parameter will be evaluated with sit-up and push-up tests. Participants' physical activities will be evaluated with the Adolescent Physical Activity Questionnaire (PAQ-A).The quality of life of individuals with PCOS will be evaluated with the Polycystic Ovary Syndrome Quality of Life-50 Scale.

Eligibility Criteria:
Inclusion Criteria of patients :

* Being between the ages of 14-24,
* Collecting Polycystic Syndrome according to Rotherdam,
* Not having had Covid-19.

Exclusion Criteria of the patients :

* Not to be between the ages of 14-24,
* Not showing the symptoms of Polycystic Ovary Syndrome (PCOS),
* Having had Covid-19,
* Having a chronic disease diagnosed other than PCOS,
* Having cognitive impairment that will affect their cooperation with tests.

Healthy group inclusion criteria

* Being a female adolescent between the ages of 14-24,
* Not having been diagnosed with any chronic disease,
* Adolescents with regular menstrual cycles,
* Not taking any medication known to affect hormone, lipid and carbohydrate metabolism,
* Not having clinical signs of hyperandrogenism,
* Not having had Covid-19.

Healthy group exclusion criteria

* Not to be between the ages of 14-24,
* Having a chronic disease,
* Having had Covid-19,
* Having cognitive impairment that will affect their cooperation with tests.
Prophylactic Use of Milrinone After Congenital Heart Surgery in Infants

This randomized, multi-center, double-blinded, placebo-controlled study is designed to evaluate the efficacy and safety of milrinone compared with placebo in participants after corrective surgery for congenital heart disease. Participants will be randomized in a 1:1 ratio within 90 minutes after arriving in the intensive care unit (ICU), to receive either intravenous milrinone or placebo for 36 hours. Participants will be stratified according Vasoactive Inotrope Score after arriving in the ICU.


Eligibility Criteria:
Inclusion Criteria:

* Age younger than 12 months
* Without pre-operative low cardiac output syndrome
* Bi-ventricular repair of congenital heart disease involving cardiopulmonary bypass
* Informed consent obtained from each participant's parent or guardian

Exclusion Criteria:

* A body weight \<2 kg
* Prematurity (birth \<36 weeks postconceptual age)
* Renal dysfunction ( Creatinine\>1.5mg/dL 48 hours before surgery)
* Low cardiac output syndrome or hypotension on arrival to ICU from OR
* Cardiopulmonary resuscitation before surgery
* Platelet count\<80,000/mm3 before surgery
* Left ventricular outflow tract obstruction before surgery
* Ventricular arrhythmia before surgery
* Without femoral artery catheter before arriving in the ICU
* Consent was withdrawn by participants' parent or guardian.
A Post-market Observational Study With the easyEndoTM Universal Linear Cutting Stapler in Standard Laparoscopic and Robot-assisted Laparoscopic Roux-en-Y Gastric Bypass (RYGB) Surgery

The primary purpose of this observational registry is to evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical when used to create anastomoses during standard and robot-assisted laparoscopic Roux-en-Y Gastric Bypass (RYGB) surgery. Stapler performance during surgery as well as post-operative pain and the clinical efficacy of the procedures will be determined as secondary objectives.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years of age at study entry.
* Patient and investigator signed and dated the informed consent form prior to the index-procedure.
* Patient has a BMI ≥ 35 kg/m2 with one or more related co-morbidity.
* Patient has a BMI ≥ 40 kg/m2.
* Patient is eligible for standard laparoscopic or for robotic-assisted laparoscopic RYGB surgery.

Exclusion Criteria:

* Patient is unable / unwilling to provide informed consent.
* Patient has a history of bariatric surgery.
* Patient is unable to comply with the study protocol or proposed follow-up visits.
* Patient has a contra-indication for standard laparoscopic or robot-assisted laparoscopic RYGB surgery.
SAD/MAD Study in Healthy Subjects and Adults With UC to Evaluate Safety, Tolerability, PK, PD of AMT-101

A randomized, double-blind placebo-controlled first in human study in approximately 36 male healthy subjects and approximately 20 male and female patients with active UC who have had an inadequate response to or demonstrated intolerance to 5-ASA.

A randomized, double-blind placebo-controlled first in human study in approximately 36 male healthy subjects and approximately 20 male and female patients with active UC who have had an inadequate response to or demonstrated intolerance to 5-ASA.

Subjects may but are not required to have been exposed to corticosteroids, or immunosuppressive agents. In case the subject has been exposed to any of these treatments, he/she must have had either an inadequate response, failed response or demonstrated intolerance.

Patients may be

1. naïve to anti-TNFα therapy or
2. have failed or demonstrated intolerance to anti-TNF-α therapy.

Eligibility Criteria:
Inclusion Criteria:

PART A (Healthy Volunteers)

* Male subject in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at screening
* Between 18 and 45 years of age, inclusive.
* Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive).

PART B (Adult Ulcerative Colitis)

* Male and Female patients 18 years and older
* Documented diagnosis of UC for at least 3 months duration
* Stable mild to moderate UC, as defined by the following criteria: Total Mayo score (excluding PGA) at least 3 but not greater than 7:
* Patients must have failed or demonstrated intolerance to aminosalicylates (e.g., 5-aminosalicylic acid, mesalamine)

Exclusion Criteria:

PART A and PART B

* Known hypersensitivity or allergy to AMT-101 or excipient contained in the drug formulation.
* Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including kidney panel, and urinalysis).

PART B

* Clinical findings of Crohn's disease
* A prior history of surgery for UC
* Prior use of integrin antagonists (vedolizumab, natalizumab), JAK kinase inhibitors (tofacitinib), cyclosporin or tacrolimus
Genomic BRCA and Extensive ovArian Cancer Testing

This is a prospective observational French multicenter cohort in patients with ovarian and/or primitive peritoneal and/or fallopian tubes carcinoma, histologically confirmed, with an advanced stage at diagnosis (stage III to IV FIGO 2014). The objective is to constitute a clinico-biological database that allows to correlate clinical and progressive features of ovarian cancer patients based on tumor genomics and molecular detected abnormalities.

This is a prospective observational French multicenter cohort in patients with ovarian and/or primitive peritoneal and/or fallopian tubes carcinoma, histologically confirmed, with an advanced stage at diagnosis (stage III to IV FIGO 2014). The objective is to constitute a clinico-biological database that allows to correlate clinical and progressive features of ovarian cancer patients based on tumor genomics and molecular detected abnormalities.

Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years.
* Patient with ovarian and/or primitive peritoneal and/or fallopian tubes carcinoma, histologically confirmed, with an advanced stage at diagnosis (stage III to IV FIGO 2014)
* Patient in first line therapy
* Available tumor sample fixed in formalin and included in paraffin (FFPE):

  * in pre-chemotherapy, insofar as possible
  * having a sufficient tumor surface, with a final cellularity of at least 20%
* Identification of a molecular genetics' cancer platform participant in GREAT and an onco-geneticists team working with the investigator team
* Patient consenting her data to be collected and submitted through an automated processing
* Patient beneficiary from the French social security

Exclusion Criteria:

* Patient with a mucinous ovarian carcinoma
* Patient pregnant or breastfeeding
* Patient under legal protection (guardianship or court order) or unable to consent
VIDAZA-DLI Pre-emptive Azacitidine and Donor Lymphocyte Infusions Following Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Acute Myeloid Leukemia and Myelodysplastic Syndrome

Patients included in the study with high risk acute myeloid leukemia or myelodysplastic syndrome as defined will receive an allogeneic transplantation conditioned by either myeloablative or reduced regimen. Following allogeneic transplantation, patients will receive a maintenance regimen combining chemotherapy with azacitidine (aza) and immunotherapy with donor lymphocyte infusion.


Eligibility Criteria:
Inclusion Criteria:

* Patients with high risk acute myeloid leukemia undergoing allogeneic transplantation with either a familial or an unrelated donor.

High risk AML is defined as :

* AML in CR1 with unfavorable cytogenetics defined by complex caryotype, autosomal monosomy combined or not with other cytogenetics abnormalities inv(3)/t(3,3), t(6;9), t(6;11), t(11;19), del(5q), del(7q).
* AML in CR2 or greater remission prior allogeneic transplantation
* AML in PR or relapse prior allogeneic transplantation
* Or Patients with high risk myelodysplastic syndrome undergoing allogeneic transplantation with either a familial or an unrelated donor.

High risk MDS is defined as :

* MDS with intermediate-2 group and higher risk group according to IPSS criteria
* Age 18 - 70 years.
* Availability of an HLA identical family donor or unrelated donor with matching in 10/10 alleles (HLA-A, B, C, DRB1, DQB1) or maximum of 1 allele or antigen mismatch OR family donor with maximum 1 allele mismatch.
* Conditioning regimen to allogeneic transplantation may be either myeloablative or reduced.
* Be able to understand and sign informed consent.
* Affiliation number to National Health Care System
* Men and women of childbearing potential must use effective contraception during and up to 3 months after treatment.

Exclusion Criteria:

* The presence of any one exclusion criteria renders the patient ineligible:
* Patient in full relapse post-transplant (\>20% blasts in the bone marrow) following allogeneic transplant
* Documented leukemic infiltration of CNS/cerebrospinal fluid.
* Karnofsky performance score below 60%.
* Acute and chronic heart failure (NYHA Class III or IV) or symptomatic ischemic heart disease.

following allogeneic transplant

* Severe liver failure (bilirubin \>30 μmoles/L, SGPT \> 4 X upper limit of normal).
* Hepatic malignancy in advanced stage.
* Severe neurological or psychiatric disorders
* Acute GVHD grade II-III. Patient with grade I GVHD may be included (see annex 1 for GHVD grade definition).
* Active uncontrolled infection.
* Denied informed consent.
* Treatment with other investigational drugs following allogeneic transplantation.
* No effective contraception
* Lactating females
* Pregnant woman
Comparison of the Effect of a Novel Starch (Glycosade) Versus Gastrostomy Tube-Dextrose Infusion on Overnight Euglycaemia Control in Children With Glycogen Storage Disease Type I: Open Label Demonstration Trial

The objective of this demonstration project is to compare a novel long-acting starch, Glycosade, a hydrothermally processed high amylopectin maize starch, versus gastrostomy tube-dextrose infusion in maintaining euglycaemia overnight in children with GSD-I. Glycosade has been reported to increase the duration of euglycaemia. Its slow release and longer periods of normal blood sugar achieved would preclude the need for the overnight dextrose infusion and eliminate the need for the surgical insertion of a gastrostomy tube for this purpose. Glycosade also reportedly causes fewer gastrointestinal side effects, thus potentially improving compliance to therapy. The investigators intend to evaluate Glycosade in our patients and determine its efficacy on glucose control, on the length of normoglycemia achieved and to determine if there are reduced side effects in our patients with GSD-I. This will be accomplished by an open label study of Glycosade in GSD-I patients who consent to the protocol.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of GSD Type 1
* Age \>5 years

Exclusion Criteria:

* n/a
Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis

This observational study will be a documentation of the prescribing and administration practices of Enbrel® and their impact on ankylosing spondylitis patients outcome in a real life setting.

The study population will be described using standard descriptive statistics for demographic, clinical, medical, characteristics, as well as for standard health-related quality of life and functional disability questionnaires .

Eligibility Criteria:
Inclusion Criteria:

* Proven diagnosis of Ankylosing Spondylitisin accordance with local guidelines
* Patients treated as an outpatient

Exclusion Criteria:

* Patients who suffer from hypersensitivity to the active substance Etanercept or to any of the excipients of Enbrel®.
* Treatment with Enbrel® should not be initiated in patients with active infections including chronic or localised infections.
* Patients with sepsis or risk of sepsis should not be treated.
A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation

The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

* Subjects who have used bupropion (Zyban or Wellbutrin) previously.
Clinical Value of Adding Dapagliflozin in Patients With Nephrotic Syndrome

Conducted as a randomized controlled clinical trial, this study aims to assess the potential benefits of incorporating dapagliflozin, an SGLT-2 inhibitor, into the treatment regimen of patients diagnosed with primary nephrotic syndrome. The primary focus is on examining the impact of dapagliflozin on two key parameters: proteinuria and estimated glomerular filtration rate (eGFR).

The trial involves adult participants who have been definitively diagnosed with primary nephrotic syndrome through renal biopsy. In conjunction with their standard care, these participants will receive a daily dose of dapagliflozin at 10 mg. Over a span of six months, they will undergo comprehensive monthly assessments. These assessments will involve the collection and analysis of urine samples to quantify proteinuria and perform urinalysis. Additionally, blood samples will be taken to determine the estimated eGFR, lipid profile, glycated hemoglobin. Participants will also be encouraged to report any potential side effects resulting from their medication intake.


Eligibility Criteria:
Inclusion Criteria:

* eGFR \> 25 mL/min/1.73m2
* Evidence of primary nephrotic syndrome by renal biopsy
* Non-diabetic kidney disease

Exclusion Criteria:

* Nephrotic syndrome secondary to lupus nephritis, AAV, amyloidosis, or secondary membranous nephropathy
* Hepatic impairment \[AST or ALT \>3 times ULN or total bilirubin \>2 times the ULN\] at the time of enrolment
* Pregnant or breast-feeding females
Multinational Observational Study to Describe Diagnostic Stage Shift in Patients With Lung Cancer Using Medical Records

Multinational observational study to describe diagnostic stage shift in patients with lung cancer using medical records. Increased lung cancer screening programs and increased utilization of other screening modalities such as large increase in community chest radiography referral rates in response to public awareness campaigns, as well as unintentional detections through cardiac CT(computed tomography) angiograms, or screening for coronary disease may help in detecting the disease at earlier curable stages. Availability and increased access to novel therapies increase the likelihood of an early-stage diagnosis aiming for improved survival.

This is a multicentric, multinational, observational study to describe the shift in stage at diagnosis of lung cancer over the time- period from baseline year to EOS (end of study). The study will be implemented in the AstraZeneca International Region (ie, non-US, non-European countries). The participating countries and sites will be selected based on the availability and accessibility of secondary data sources such as lung cancer databases or EMR (electronic medical records) in the target countries. Once countries and databases are selected, the protocol will be adapted for the specific country including details about the patient databases. The study will be conducted in compliance with the local legal, ethical, and regulatory requirements of the selected countries. The study-specific data will be extracted from the databases and recorded using eCRF (electronic case report form). This study does not involve direct recruitment of the patients. Aggregated data from the databases for each consecutive year starting from the baseline year until EOS, of patients with lung cancer meeting the inclusion criteria will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Adult female and male patients ≥18 years old.
* Confirmed diagnosis of lung cancer (either cytologically or histologically)

Exclusion Criteria:

* Patients presenting with recurrent or relapsed lung cancer.
* Patients with a concomitant cancer at the time of diagnosis of lung cancer, except for nonmetastatic nonmelanoma skin cancers, or in situ or benign neoplasms: a cancer will be considered concomitant if it occurs within 5 years of lung cancer diagnosis.
Ultrasound Guided Positioning of Central Venous Catheters

The current standard for (correct) position control of a central venous catheter (CVC) is X-ray control, which is associated with X-rays for the patient. In some clinics, radiological services are not offered "around the clock". Therefore, an alternative that is not burdensome for patients and is available on all sides would be desirable. The possibility of a sonographic CVC position control is to be investigated.

The correct position of a central venous catheter is important. Complications/failure must be detected early/immediately. In addition to the X-ray of the thorax, a position control by means of an ECG derivative (α-card derivative) is available for position control. The method is easy to perform, but an epicardial or an arterial position of the CVC cannot be detected without the use of additional imaging in case of doubt.

For the reasons mentioned above, sonography is a suitable method to show the inflow of injected 0.9% sodium chloride solution into the right atrium, which allows to conclude the correct position of the CVC.


Eligibility Criteria:
Inclusion Criteria:

* elective insertion of a central venous catheter.

Exclusion Criteria:

* emergency insertion of a central venous catheter
Midodrine and Albumin in Patients With Refractory Ascites

Refractory ascites is seen in 5-10% of patients with cirrhosis.Decompensated cirrhosis with refractory ascites has a mortality rate of around 40% in a year and a median survival of 6 months.Portal hypertension and splanchnic vasodilation are major factors in the development of ascites.The treatment of refractory ascites involves salt restriction, diuretics, large volume paracentesis (LVP), transjugular Intrahepatic Portosystemic shunt (TIPS) and Liver Transplantation (LT). Currently the only curative treatment is LT. However, LT is limited due to organ shortage and high cost.

Long-term human albumin (HA) administration in patients with uncomplicated and refractory ascites, has shown to improve survival or delay the complications of cirrhosis. Midodrine, an oral α1- adrenergic agonist has been used in refractory ascites with variable results. However, there is no study on the use of long term Midodrine and HA in patients with refractory ascites. Therefore, we plan to study the effect of long term midodrine and HA in patients with refractory ascites.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 80 years
2. Refractory ascites in cirrhosis of any etiology

Exclusion Criteria:

1. Mixed ascites: cirrhosis plus another cause of ascites
2. Gastrointestinal bleed within 7 days of enrolment.
3. Presence of hepatorenal syndrome
4. Hepatic encephalopathy grade 2 or higher
5. Infection within 1 month preceding the study
6. Cardiovascular disease (ejection fraction \< 35% or abnormal ECG) or arterial hypertension (BP \> 140/90 mm of Hg)
7. Abnormal urine analysis with proteinuria \> 500 mg/24 hour or 50 red blood cells/high power field, or granular casts or ultrasonographic evidence of intrinsic renal disease
8. Presence of hepatocellular carcinoma or portal vein thrombosis
9. Treatment with drug with known effects on systemic and renal hemodynamics within 7 days of inclusion excepting beta-blockers
10. Patient not willing for study.
11. Patient opting for liver transplantation/ transjugular intrahepatic portosystemic shunt