cyrilzakka/clinical-trials huggingface dataset:
A Study of Duvelisib in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)

A Two-arm, Phase 1b/2 Study of duvelisib Administered in Combination with Rituximab or Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma.

This is a two-arm, open-label, Phase 1b/2 trial designed to evaluate the safety and efficacy of duvelisib in combination with rituximab and duvelisib in combination with obinutuzumab in subjects with previously untreated CD20+ FL.

The study will be conducted in two parts, a Safety Lead-in (Part 1) followed by a randomized, 2-Stage Design in Part 2. Each treatment arm will be assessed independently for dose limiting toxicity (DLT) within Part 1.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CD20+, follicular lymphoma that has not been treated
* CD20-immunophenotyping of tumor to document B-cell follicular lymphoma
* Stage II disease with bulky disease (≥ 7cm lesion), Stage III, or Stage IV disease
* Disease that requires treatment based on the Investigator's opinion (e.g., meets GELF criteria)
* At least one measurable lesion that is \> 1.5 cm in at least one dimension
* Eastern Cooperative Oncology Group (ECOG) performance status \<=2 (corresponds to Karnofsky Performance Status \[KPS\] \>=60%)

Exclusion Criteria:

* Received systemic treatment for lymphoma such as chemotherapy, immunotherapy, radiotherapy, investigational agents, or radioimmunotherapy.
* Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3B follicular lymphoma
* Severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or known hypersensitivity to any of the study drugs
* Prior allogeneic hematopoietic stem cell transplant
* Prior, current or chronic hepatitis B or hepatitis C infection
* Human immunodeficiency virus (HIV) infection or Human T Cell Lymphotropic Virus 1 (HTLV-1) infection
5 Year Observation of Patients With PORTICO Valves

The purpose of this clinical investigation is to further assess the performance and safety profile of the commercially-available Portico™ TAVI System in patients with severe symptomatic aortic stenosis.

This is an international multicenter, prospective, non-randomized clinical investigation without concurrent or matched control, designed to assess the mid-term safety and performance of the Portico valve in patients with severe symptomatic aortic stenosis whom are high risk for surgical valve replacement. The primary endpoint is 1 year all-cause mortality. In addition, the performance and safety profile of the Portico valve will be further evaluated at 30 days, 1 year, and annually through 5 years post-implant.

The investigation will be conducted at approximately 65 centers in approximately 15 countries in Europe, Middle-East, Africa, Canada, Australia and New Zealand.

Eligibility Criteria:
Inclusion Criteria:

* Patient has signed the Patient Informed Consent prior to participating in the clinical investigation.
* Patient has been referred for a Portico Valve implant as per Heart Team decision or patient has received a Portico Valve as per participation in an SJM sponsored regulatory or first-in-human trial.
* Patient has senile degenerative aortic valve stenosis confirmed by echocardiographically derived criteria\*:

  * An initial aortic valve area (AVA) of less than or equal to (≤) 1.0 cm2 (or indexed EOA less than or equal to (≤) 0.6 cm2/m2) AND
  * A mean gradient greater than (\>)40 mmHg or jet velocity greater than (\>)4.0 m/s or Doppler Velocity Index less than (\<)0.25. If the mean gradient is \<40 mmHg and left ventricular ejection fraction (LVEF) \<55%, then the site may as well perform a dobutamine stress echo to see if the mean gradient increases to \>40 mmHg." (Baseline measurement taken by echo within 6 months of index procedure.)
* Patient has a life expectancy more than (\>) 12 months.

For patients enrolled in a French site:

* Patient is at high risk for surgery as demonstrated by a Logistic EuroSCORE equal or more than (≥) 20 and/or a Society of Thoracic Surgeon (STS) mortality risk score of more than (\>) 10% and/or by clinical judgment of the Heart Team based on the individual risk profile (comorbidities).

  * Not applicable for a patient who has received a Portico Valve as per participation in an SJM sponsored Regulatory or First-In-Human trial.

Exclusion Criteria:

* Any case in which the Portico Valve would not be indicated for the patient as per current instructions for use (i.e any "off-label" use).
* Patient has any other aortic valve than tricuspid one.
* Patient has a prosthetic valve or ring in the aortic position.
* Patient needs a concomitant structural heart procedure..
* Patient needs the usage of an embolic protection device.
* Patient is unwilling or unable to comply with all clinical investigation-required follow-up evaluations.
* Patient is pregnant
Clinical Study Investigating the Conversion of the Contraceptive Compound Norethisterone Within the Body Towards the Contraceptive Compound Ethinylestradiol

The clinical phase I study aims at investigating the conversion of the contraceptive compound norethisterone within the body towards the contraceptive compound ethinylestradiol. Therefore concentrations of ethinylestradiol will be measured from blood samples after administration of a single intramuscular dose of norethisterone. In a comparison arm concentrations of ethinylestradiol will be measured from blood samples after administration of a pill containing ethinylestradiol itself.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female subject
* Age: 18 to 45 years (inclusive) at the first screening examination / visit
* Body mass index (BMI): above or equal 18 and below or equal 30 kg / m²
* At least 3 months since delivery, abortion, or lactation before the first screening examination / visit

Exclusion Criteria:

* - Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Liver diseases, kidney diseases, metabolic disorders, thyroid disorders and known or suspected malignant or benign tumors
* Presence or a history of venous or arterial thrombotic/thromboembolic events
* Migraine with neurologic symptoms (complicated migraine)
* Clinically significant depression
* Pancreatitis or a history thereof if associated with severe hypertriglyceridemia
* Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them
Effect of Drinking Carbohydrate-containing Fluids on Gastric Residual Volume in Elderly Patients

In the past, some guidelines advised no oral intake for at least 8 hours before any surgery. However, research has shown risks associated with excessive fasting, such as postoperative insulin resistance, and advantages in shorter fasting protocols, such as reduced postoperative nausea and vomiting.

The perioperative fasting guidelines of the European Society of Anaesthesiology focus on preoperative carbohydrates. They hold that it is safe for patients to drink carbohydrate-rich fluids up to 2 hours before elective surgery and that drinking carbohydrate-rich fluids improves subjective well-being, reduces thirst and hunger, and reduces postoperative insulin resistance at an evidence level of 1++. Nevertheless, data on drinking carbohydrate fluids before surgery in elderly patients are limited.

In our institution, there are two clinical pathways for total knee arthroplasty according to the surgeons. One difference is whether carbohydrate fluids drink or not before surgery. The purpose of this study, therefore, is to assess gastric volume in fasted elderly patients using ultrasound after they drank carbohydrate fluids 2 hours before surgery and to compare with matched patients using age, body mass index, and comorbidity, who did not drink carbohydrate fluids before surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing total knee arthroplasty
* Age: 65\~85 yeas
* ASA 1\~3

Exclusion Criteria:

* Age \< 65 years
* ASA \>= 4
* Diabetes mellitus
* Chronic kidney disease
Sleep-wakefulness Status in Preterm Infants

This study was conducted to compare the effectiveness of three stair positioning pillows and positioning materials on the sleep-wakefulness status of preterm infants.

It is known that newborns have similar brain activity in the intrauterine period and REM sleep activity, and they sleep more than adults and spend most of their sleep in the REM sleep period. Therefore, sleep quality in the newborn period is directly related to healthy development. Providing a developmentally supportive position in neonatal intensive care units (NICU) is necessary not only for neuromotor and musculoskeletal development, but also for physiological function and stability, thermal regulation, bone density, neurobehavioral organization, calmness and comfort, skin integrity, optimal musculoskeletal development, facilitation of sleep, growth and brain development. Excessive noise in the NICU, prolonged bright lights, separation from the mother, frequent invasive procedures and pain experience are among the factors that disrupt, shorten and create stress in the sleep duration of preterm babies. It is very important to support the sleep of preterm babies in the NICU in order to improve their growth and development, especially their brain development. It is known that therapeutic positions, which are one of the individualized developmental care practices, are effective on sleep.This study was conducted to compare the effectiveness of three stair positioning pillows and positioning materials on the sleep-wakefulness status of preterm infants.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants who were postmenstrual age ≥30 and ≤34,
* had an appropriate weight for gestational age (AGA),
* were spontaneously breathing (extubated and not receiving any oxygen support),
* had no history of previous intubation, routinely had caffeine in their diet, and
* whose parents volunteered to participate in the study were included in the study.

Exclusion Criteria:

* Preterm infants who were \<30 and \>34 years postmenstrual,
* had bradycardia,
* received an analgesic 4 hours before that could affect sleep,
* had sepsis,
* congenital anomalies,
* intracranial hemorrhage,
* hyperbilirubinemia,
* hypoglycemia,
* underwent surgery,
* received any oxygen support, or were on mechanical ventilation were excluded from the study.
Effect of Hydroxychloroquine in COVID-19 Positive Pregnant Women

COVID-19 was declared a pandemic on March 11th. Efforts to save lives are essential as we will face increasing morbidity with rising demands on health care resources. Since pregnant women with COVID-19 have systematically been excluded from drug trials, potential treatment options for these high-risk individuals remain untested. The aim of our trial is to determine whether hydroxychloroquine given to COVID-19 positive pregnant women can reduce COVID-19-related hospital admissions, thereby allowing women to stay at home while limiting utilization of hospital resources and resulting exposure of health care providers.

Due to physiologic and immune changes, pregnant women are at high risk of severe complications and mortality from COVID-19 infections. Despite this, epidemiologic data on SARS-CoV-2 infection in pregnancy is currently limited to small case-series describing a clinical course ranging from mild to critical illness requiring extracorporeal membrane oxygenation. Chloroquine and hydroxychloroquine (HCQ) have demonstrated activity against SARS-coronaviruses in laboratory studies and are being tested in COVID-19 positive patients. HCQ appears more promising than chloroquine due to its greater effectiveness against SARS-CoV-2 in vitro and better safety profile. To date, pregnant women have been systematically excluded from trials conducted in the general outpatient population. Thus, we will carry out a randomized, placebo-controlled, double blinded trial of HCQ (considered safe in pregnancy in pregnant women with early COVID-19 infection across Canada to evaluate its effect in reducing COVID-19-related hospitalizations. This outpatient intervention is of paramount importance as its goal is to avoid overloading emergency rooms, obstetric triage, inpatient wards and critical care units. Upon completion of 6-month, our results can be directly applied to clinical care.

Eligibility Criteria:
Inclusion Criteria:

* Women with a self-reported live pregnancy \>14 weeks
* Presently in the outpatient setting (i.e. not admitted to the hospital)
* Tested positive for COVID-19 within last 7 days
* Must be living in Canada

Exclusion Criteria:

* Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Known cardiac disease (or under investigation)
* Currently taking medication contraindicated as per Health Canada list for hydroxychloroquine
* Known retinopathy
* Known hypersensitivity to 4-aminoquinoline compounds
* Already taking hydroxychloroquine
* Unwilling to answer follow-up questionnaires
* Currently in labor
* Inpatient women at time of COVID-19 diagnosis.
Prognostic Significance of the Uncertain Resection in NSCLC

The concept of residual tumor classification proposed by the Union for International Cancer Control (UICC) was used to assess the completeness of surgical resection, and non-small cell lung cancer (NSCLC) patients with incomplete resection were more likely to occur recurrence, leading to significantly poor survival. But this R classification only refers to the surgical margin and neglects other factors associated with surgical quality, such as the extent of lymph node dissection (LND). Therefore, the International Association for the Study of Lung Cancer (IASLC) proposed the definition of uncertain resection \[R(un)\], which includes the suboptimal extent of LND. However, the clinical significance of R(un) is still controversial. On the one hand, some researches demonstrated that R(un) had definite prognostic significance, with R(un) survival stratifying between R0 and R1. On the other hand, some studies indicated that in early-stage NSCLC, the suboptimal extent of LND had no impact on survival, and the concept of R(un) might be insignificant in these patients. Even in those studies supporting the prognostic significance of R(un), which kind of patients is suitable for R(un) was still unclear. Thus, the investigators explore the impact of the R(un) on the long-term survival of patients with NSCLC using a large cohort in China, to identify those patients who could really benefit from the LND required by the R0 classification proposed by IASLC.


Eligibility Criteria:
Inclusion Criteria:

1. Primary non-small cell lung cancer
2. With pulmonary resection

Exclusion Criteria:

1. Sublobar resection
2. R1/R2
3. Positive highest mediastinal lymph nodes
4. Operative death
Evaluation of YouControl-AFib, a mHealth Application for Persons With Atrial Fibrillation

This study is being done to establish the feasibility of performing a clinical trial using a mHealth application named YouControl-AFib designed to improve the cardiovascular health of persons with atrial fibrillation. The study will obtain feedback on the app design to inform future versions and will collect preliminary data to support proof-of-concept and potential effect sizes for future trial design.

Primary Objective

* To effectively recruit participants for a clinical trial and obtain user feedback on the mHealth app using the Mobile App Rating Scale and focus group sessions.

Secondary Objectives

* To evaluate the impact of the YouControl-AFib mHealth app (pilot version, 3 months of use) on physical activity in persons with atrial fibrillation.
* To obtain several additional functional and disease specific endpoints that will help establish possible effect sizes to be evaluated more formally in subsequent versions of the mHealth application.
* To obtain user feedback on the mHealth app using the Mobile App Rating Scale and focus group sessions.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and the willingness to sign a written informed consent document
* Willing to comply with all study procedures and be available for the duration of the study
* SmartPhone capable of pairing with a Fitbit Sense 2 and Fitbit App (Apple iOS 15 and higher or Android 10 or higher)
* Paroxysmal or persistent atrial fibrillation verified by 12-lead electrocardiogram (ECG) or other clinical grade monitoring
* body mass index (BMI) greater than 27

Exclusion Criteria:

* History of permanent atrial fibrillation
* Left ventricular ejection fraction (LVEF) less than 45 percent
* Myocardial infarction, coronary artery bypass grafting, or valve surgery within the last 12 months
* Moderate to severe valve disease
* Inability to participate in a structured exercise program due to musculoskeletal disease
* Already participating in a structured exercise program or achieving guideline directed physical activity
* Planned surgery or procedure during the next three months that limit ability to engage in physical activity
Biomarkers to Measure Treatment Response for Alcohol Dependence

The purpose of the research study of the K23 award is to develop a blood test that can check how much alcohol a person has consumed in the past few days. We will enroll heavy social drinkers who do not have alcohol-related problems but used to drinking 5 or more beers on a single occasion. Both men and women between ages 21 and 65 years can join the study. All participants must be of European decent.


Eligibility Criteria:
Inclusion Criteria:

* Experienced binge drinking episode(s) (5 or more standard drinks for men and 4 or more standard drinks for women consumed in about 2 hours according to NIAAA definition) in the past 30 days

Exclusion Criteria:

* DSM-IV diagnosed alcohol dependence, other drug dependencies including nicotine dependence
A Mobile Application Based Dietary Self Management Intervention in Chinese Chronic Kidney Disease Patients

This is a multi-center randomized controlled study. This study aims to investigate the acceptability and efficacy of a newly developed mobile application in the dietary management of chronic kidney disease (CKD) patients.

The prevalence of CKD has reached 10.8% in China. Increasing in prevalence of other non-communicable disease such as hypertension, diabetes and obesity is contributing to this rise in CKD and end-stage renal disease prevalence. Diet is a strong modifiable factor in these diseases. Dietary control is also an integral part in CKD disease self management. However, the complexity in the dietary management of CKD makes it hard for patients to adequately self manage. With the development of smart phone, many mobile applications have been developed to suit the need of patients with chronic diseases. But there has been a scarce of randomized trial to support the feasibility, acceptability and efficacy of these mobile applications.

Our study aims to employ a newly developed dietary logging and monitoring application in the primary care setting of CKD patients to test its acceptability and efficacy in disease control.

The application is developed by a multidisciplinary team in a tertiary care center. The main features include searching and logging foods, receiving realtime feedback on key nutrient intake levels and facilitating patient-care giving communication.

We plan to enroll 14 tertiary hospitals and 42 secondary hospitals in 7 geographical regions in China aiming to reach participants in resource poor areas. Participants will be randomized with 1 to 1 ratio to either receiving mobile application dietary intervention or usual dietary consultation. The planned intervention period is 3 months. We will monitor biochemical parameters relating to dietary control and evaluate patient-centered outcomes concerning CKD self management and control.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with CKD for more than 3 months
* Objective measures of kidney disease (fulfill one of the following): 1) eGFR≤60ml/min/1.73m\^2; 2) Proteinuria (Protein + on dipstick or 24 hour urine protein\>0.3g or albumin-to-creatinine ratio (ACR) \>30mg/mmol or protein-to-creatinine ratio (PCR) \>50mg/mmol); 3) Imaging proven kidney disease (Atrophy, stone formation, cystic kidney disease, or other structural abnormality)
* Having access to a mobile phone and is capable of using the dietary intervention application

Exclusion Criteria:

* Can not provide history of kidney disease or can not provide laboratory result for the past 3 month
* Can not use a mobile phone or deemed unfit to participate by their treating nephrologist
Impact of Resected Gastric Volume on Postoperative Weight Loss After Laparoscopic Sleeve Gastrectomy for Morbid Obesity

Impact of resected gastric volume on postoperative weight loss after laparoscopic sleeve gastrectomy for morbid obesity. Observational study with a mathematical method to approximate the calculation of the resected gastric volume after a sleeve gastrectomy and see the outcome on weight loss.


Eligibility Criteria:
Inclusion Criteria:

* BMI over 60 kg/m2 in high-risk patients,
* BMI between 50 and 60 kg/m2 in nondiabetic patients,
* BMI between 40 and 50 kg/m2 in patients refusing a complex procedure like Roux-en-Y gastric bypass,
* patients with severe gastric inflammatory disease and H. pylori infection,
* patients with previous abdominal surgery involving the intestines, and young patients refusing gastric banding

Exclusion Criteria:

* severe and documented gastroesophageal reflux disease
* previous gastric surgery.