cyrilzakka/clinical-trials huggingface dataset:
Daytime Impact Sleep Study

This trial will investigate the relationship of sleep, daytime performance and nocturia in patients treated with Desmopressin or placebo. Male and Female patients will be administered Desmopressin or Placebo every day for 3 months.


Eligibility Criteria:
Inclusion Criteria:

* At least 2 night time voids per night
* Habitual sleep of 6-9.5 hours per night
* Experiencing symptoms of Nocturia greater than 6 months

Exclusion Criteria:

* Greater than 10 night time voids
* History of sleep apnoea and PLMS (Periodic Limb Movements of Sleep)
* Other sleep disorders
* Signs or symptoms of: Bladder outlet obstruction, severe lower urinary tract symptoms (LUTS), interstitial cystitis, moderate to severe overactive bladder (OAB), moderate to severe as judged by the investigator stress urinary incontinence
* Urological malignancies
* Neurogenic detrusor over activity (e.g. Parkinson, spinal cord damage, etc.)
* Central or nephrogenic diabetes insipidus
* Habitual or psychogenic polydipsia (fluid intake resulting in a urine production exceeding 40ml/Kg/24hrs)
* Syndrome of inappropriate antidiuretic hormone (SIADH)
* Cardiac failure evidence based on physical examination, cardiac medical history and electrocardiogram (ECG) output
* Uncontrolled hypertension
* Uncontrolled diabetes mellitus
* Hyponatraemia with sodium \<135 mmol/L
* Renal insufficiency
* Known or suspected clinically significant hepatic and/or biliary diseases
Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema

The treatment of lymphoedema and its associated complications represent a considerable drain on increasingly limited NHS resources. Intermittent pneumatic compression (IPC) represents an innovative treatment for this condition, however the efficacy of IPC as a treatment for lower limb lymphoedema needs to be investigated via robust clinical research.

The primary aim of this research is to evaluate the effectiveness of intermittent pneumatic compression (IPC) as a treatment for lower limb lymphoedema as a whole, and to compare the effectiveness of a new generation device, in this case the LymphAssist (Huntleigh Healthcare), against older sequential models. The study methodology consists of a pilot randomised control trial of two groups - Intervention group A will continue to receive their standard lymphoedema care but will also be provided with a LymphAssist IPC device to use, mimicking manual lymph drainage therapy. Participants in intervention group B will receive their standard care plus an IPC device that uses sequential therapy. Each participant will act as a control for a 5 week period continuing with their standard treatment only. Outcome measures include impact on limb volume, skin stiffness and elasticity score and impact on quality of life scores.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over,
* Able to provide written consent,
* Confirmed diagnosis of lower limb ISL stage II or III.

Exclusion Criteria:

* • Unable to provide written consent

  * Severe congestive heart failure
  * Severe skin problems, lower limb ulcers or wounds.
  * Presence of cognitive impairment (permanent or intermittent) which would prevent patients from using the IPC device safely or adhering to instructions/study protocol.
  * Non-pitting chronic lymphoedema.
  * Known or suspected deep vein thrombosis.
  * Pulmonary embolism.
  * Thrombophlebitis.
  * Acute inflammation of the skin (erysipelas, cellulitis).
  * Uncontrolled/severe cardiac failure.
  * Pulmonary oedema.
  * Ischaemic vascular disease.
  * Active cancer diagnosis.
  * Active metastatic diseases affecting the oedematous region.
  * Oedema at the root of the extremity or truncal oedema.
  * Severe peripheral neuropathy.
Prognostic PET/CT Model in Non Small Cell Lung Cancer

Prospective validation of a prognostic model based on advanced PET/CT image analysis in non small cell lung cancer

Validation on a prospective cohort of patient of a predictive model for survival based on image derived parameters

Eligibility Criteria:
Inclusion Criteria:

* non small cell lung cancer
* initial fluorodeoxygluoces (FDG) PET/CT before treatment

exclusion criteria:

* none
Dynamic Contrast Enhancement Computed Tomography for Evaluating Tumor Perfusion in Patients with Metastatic Renal Cell Carcinoma Receiving Targeted Therapies: Renal Cell Carcinoma (RCC) Scramble

This is a companion protocol to MD Anderson Cancer Center study 2010-0085 (Sequential Therapy in Advanced Renal Cell Carcinoma Therapy: The "START" Trial).

The goal of this clinical research study is to learn if dynamic contrast enhanced computed tomography (DCE-CT) scans can help researchers learn if the study drug received as part of study 2010-0085 (either everolimus, bevacizumab, or pazopanib) is working.

To perform a DCE-CT scan, a small amount of a special dye (called "CT contrast medium") is injected by vein into the body. Several CT images are then taken over a few minutes to learn how much dye spreads outside of the tumor. This can show how much blood flows to and from the tumor. By performing DCE-CT scans after several weeks on treatment, researchers may learn if changes in blood flow may be a sign that the treatment is working.

Study Procedures:

If you are found to be eligible to take part in this study, you will have a DCE-CT scan to check the status of the disease at the following times:

* Within about 4 weeks before you begin treatment on study 2010-0085.
* Eight (8) weeks after starting treatment on study 2010-0085.

Before each of the DCE-CT scans are performed, blood (about 1 tablespoon) will be drawn to check your kidney function.

If your doctor thinks it is needed, you will also have a standard-of-care CT scan at these timepoints to check the status of the disease.

Length of Study:

Your participation in this study will be over after the scan(s) 8 weeks after starting treatment on study 2010-0085. You will be taken off of this study if you leave the 2010-0085 study early.

This is an investigational study. The DCE-CT scan is commercially available. Using DCE-CT scans to check the status of kidney cancer is investigational.

Up to 120 patients will take part in this study. All will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Patient must be enrolled or being considered for enrollment on protocol 2010-0085.
2. Patients must have metastatic renal cell carcinoma (RCC).
3. Age \>/= 18 years.
4. Subjects must have adequate renal function as defined by serum creatinine \< 1.5x upper limit of normal.

Exclusion Criteria:

1. Radiotherapy: Subjects may not have received prior radiotherapy to the index lesion within 4 weeks
2. Female subjects who are pregnant or lactating.
3. Female subjects of childbearing potential (unless they have a negative serum or urine pregnancy test within 3 days prior to start of study treatment).
4. Allergy to CT contrast media requiring the administration of steroid prophylaxis.
Study to Evaluate Safety and Efficacy of ASC42 Combined With ETV and PEG-IFN α-2a in Subjects With HBV

This is a phase2, randomized, single-blind, placebo controlled and multi-center study in adults with chronic hepatitis B virus. The study is aimed at evaluating efficacy and safety of ASC42 in combination with entecavir and pegylated interferon α-2a in subjects with chronic hepatitis B virus.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old (including 18 and 65 years old);
* Chronic HBV infection confirmed by serological, etiological and clinical diagnosis (HBsAg positive for more than 6 months);
* HBV-DNA negative after nucleoside (acid) treatment;
* Laboratory test values meet the following requirements :

  * Liver function : AST, ALT ≤ 3×ULN; serum total bilirubin≤2×ULN; direct bilirubin≤1.5×ULN; serum albumin≥35 g/L (blood collection is not within 2 weeks before transfusion of albumin);
  * Hematology: white blood cell count\>3.0×109/L, ANC\>1.5×109/L; platelet\>1×ULN; hemoglobin 120g/L. (No blood transfusion (including transfusion of red blood cells and platelets) and EPO, TPO, leukocyte-stimulating factor were required within 2 weeks before blood collection) ;
  * Renal function: serum creatinine≤1×ULN;
  * Thyroid function: TSH and T4 in normal range or thyroid function can be completely controlled ;
  * Determination of serum immunoglobulin : IgM≤ULN;
  * Coagulation function: International normalized ratio: INR≤1×ULN;

Exclusion Criteria:

* Chronic HBV with unexplained portal hypertension;
* Subjects with liver cancer or serum AFP \>1×ULN;
* Previously received FXR therapy;
Egyptian Hypertrophic Cardiomyopathy Program

Egyptian HCM program aims at defining incidence, severity, phenotype, genotype and determinants of the disease in Egypt, and providing state-of-the-art treatment strategies including medical, surgical and interventional procedures which are patient- and disease-specific.

This project aims to:

* Define incidence, severity, phenotype, genotype and determinants of the disease in Egypt.
* Characterise the phenotype and genotype of several large cohorts with inherited muscle disease and their relatives.
* Provide state-of-the-art treatment strategies including medical, surgical and interventional procedures which are patient- and disease-specific.
* Study the basic mechanisms responsible for the different phenotypes at a molecular and cellular level including genotype-phenotype correlation.
* Provide a special focus for studying patients who are genotype positive and phenotype negative which we believe could yield critical data regarding the evolution of the disease.
* Develop sophisticated laboratory studies for single cell electrophysiology and immunocytochemistry and others focusing on the explanted human material from the surgical program.
* Define the role of microvascular coronary artery in the development and progression of the disease.
* Training Egyptian cardiologists, cardiac surgeons and scientists on state-of-the-art diagnosis and management of heart muscle disease including the latest developments in imaging, novel surgical techniques, coronary physiology, next generation sequencing, bioinformatics and cellular electrophysiology.

Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed with hypertrophic cardiomyopathy (index patients) who are willing and consented to participate in the registry.
* All family members of index patients who are willing and consented to participate in the registry.

Exclusion Criteria:

* Refusal to consent to participate in the registry program.
US Expanded Access Program for Magrolimab in Patients With Relapsed or Refractory Acute Myeloid Leukemia

The goal of this expanded access program is to provide rapid access to magrolimab free-of-cost material, to treat patients in the United States suffering from relapsed or refractory acute myeloid leukemia (AML).


Eligibility Criteria:
Key Inclusion Criteria:

* Individuals with confirmation of acute myeloid leukemia (AML) according to WHO 2016 classification who are refractory or relapsed, ineligible for all known drugs with proven efficacy, and ineligible for existing clinical studies; and the treating physician has assessed that the potential benefits of magrolimab outweigh the risks.
* Eastern Cooperative Oncology Group performance status score of 0 to 3.
* Treating physician plans to administer magrolimab in combination with azacitadine/venetoclax or magrolimab in combination with azacitadine alone, following the indication-specific combinations described in the protocol.

Key Exclusion Criteria:

* Known hypersensitivity to magrolimab, azacitidine, venetoclax, their metabolites, or formulation excipients, if applicable to planned treatment regimen.
* Prior treatment with cluster of differentiation (CD)47 or signal regulatory protein alpha (SIRPα)-targeting agents.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Systolic Function and Weaning-induced Pulmonary Edema (SystoWean Study)

The purpose of this study is to determine if the left and right ventricular systolic function is involved in the development of weaning failure related to weaning-induced pulmonary edema.

Weaning from mechanical ventilation remains a central step in the management of critically-ill patients, since weaning failure and prolonged duration of mechanical ventilation are not only associated with an increase in the length of stay in intensive care but also with greater morbidity and mortality. One of the well-recognized causes of weaning failure is weaning-induced pulmonary edema (WIPO), which accounts for almost 60% of the causes of weaning failure and ranging up to 75% in high-risk patients, i.e. patients with medical history of chronic heart disease, chronic respiratory failure and obesity.

Echocardiography is increasingly used in intensive care and allows non-invasive assessment of diastolic function as well as left ventricular (LV) and right (RV) systolic function, including during a spontaneous breathing test. Although LV diastolic dysfunction appears to be a major determinant of WIPO, the role of LV and RV systolic dysfunction is less unequivocal and has been poorly studied so far. Scarce data showed that patients experiencing WIPO tended to exhibit more frequently LV systolic dysfunction, as demonstrated by a lower LV ejection fraction (LVEF) and no study but two have investigated the potential role of RV systolic function. Moreover, assessing LV systolic function with LVEF measurement suffers from several limitations, especially in critically-ill patients.

Thus, the main goal of this study is to investigate whether LV and RV systolic function is involved in the development of WIPO. The second goal of this study is to determine the best echocardiographic parameter to assess LV and RV systolic function during the weaning process.

Eligibility Criteria:
Inclusion Criteria:

1. Invasive mechanical ventilation for more than 48 hours
2. Patients indicated, according to intensivists, for carrying out a spontaneous breathing trial weaning test, based on the presence of all of the following criteria:

   1. SpO2\> 90% with FiO2 ≤40% and PEEP ≤5 cmH2O
   2. Cough effectiveness on tracheal aspirations
   3. Lack of hemodynamic instability and of disorders of consciousness
3. Patients at high risk of weaning-induced pulmonary edema (WIPO), defined by one or more of the following criteria:

   1. Obesity, defined by a body mass index\> 30 kg/m²
   2. Chronic obstructive pulmonary disease
   3. Chronic heart disease

Exclusion Criteria:

1. Age \<18 years and pregnant women
2. Patients with a decision of not to resuscitate
3. Poor echogenicity
4. Severe mitral valve disease (leakage and/or stenosis, bioprosthesis)
5. Patients with pacemaker
6. Tracheostomy
7. Chronic neuromuscular or neurodegenerative diseases
Dietary Oxalate and Innate Immunity in Kidney Stone Disease

This study will test whether oxalate stimulates urinary crystals and impacts the immune system in healthy subjects using two controlled diets (low and high oxalate).

Oxalate is a small molecule found in plants and plant-derived food. It has been shown that meals containing high amounts of oxalate can increase urinary oxalate excretion, which is a risk factor for calcium oxalate kidney stones (CaOx KS). Small increases in oxalate can stimulate urinary crystals to form which can elicit an immune response. This study consists of having healthy subjects consume both low and oxalate enriched diets to evaluate the effect of oxalate on urinary crystals and immune responses. Participants will receive a low or high oxalate diet for 4 days prior to having a wash out period for 6 days. Participants will then crossover to the opposite oxalate diet for four more days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects (men and women) between the ages of 18 and 60 years of age
* No calcium oxalate kidney stones or other medical conditions
* Normal comprehensive metabolic panel (CMP)
* Non tobacco users
* Not pregnant
* BMI between 20-30 kg/m2
* Willing to abstain from vigorous exercise and vitamins/supplements during the study
* Willing to consume only provided diets, accurately collect 24-hour urine samples, and have blood drawn

Exclusion Criteria:

* Inability to sign and read the informed consent
* Any medical, psychiatric, or social conditions that would prohibit participants from abiding by the study requirements
* Physician refusal
* Pregnant women
* Active medical problems
* History of kidney stones or any medical condition that could influence absorption or excretion of oxalate
* Tobacco users
* Taking medications or dietary supplements
* BMI \>30 or \<20
Using Re-inforcement Learning to Automatically Adapt a Remote Therapy Intervention (RTI) for Reducing Adolescent Violence Involvement

This study will use a randomized control trial (RCT) design to administer two versions of a multisession remote behavioral intervention for youth seeking Emergency Department care for a violent injury with the goal to reduce their violence involvement and associated negative behaviors and consequences. The study examines two versions of the remote therapy intervention - a standard RTI (S-RTI) and an Artificial Intelligence RTI (AI-RTI). The application of a just-in-time adaptive strategy to address youth violence is an important and novel direction for this research, particularly given the need to understand best practices for delivering behavioral interventions among lower-income populations.

The Specific Aims for the proposed study are to refine the Remote Therapy Intervention (RTI) for delivery using a standardized remote therapy package (S-RTI; 1 ED + 5 remote sessions) based on a piloted RTI and an adaptive RTI that optimizes bi-weekly dose and intervention intensity between four levels of therapy (remote therapy+, remote therapy; automated electronic tailored therapy; none) based on a reinforcement learning (RL) algorithm \[AI-RTI\]. A total of 750 youth (age=14-24) seeking ED care for a violent injury will be enrolled and randomly assigned (stratified by age/gender) to the S-RTI (n=250), AI-RTI (n=300), and a control (EUC; n=200) condition. In addition to the randomized assignment, all youth will take a daily assessment over the course of the intervention timeline. Outcomes will be assessed at 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Youth will be eligible if they screen is positive for seeking treatment in the ED for a violent injury, age 14-24, and report ownership of a smartphone with texting capability and internet access.

Exclusion Criteria:

* Youth will be excluded if they do not understand English, cannot provide informed consent due to mental incompetence, incarceration or medical instability (unstable patients will be recruited if they stabilize within 72 hours), are 14-17 years old and presenting without an accessible parent/guardian, are presenting for suicide attempt/intent, sexual assault, and/or child abuse (due to high intensity of social services needed for such patients during their ED visit).
Does Emotional Support Decrease In Vitro Fertilization Stress?

In vitro fertilization for infertility has been associated with a significant amount of treatment related stress for patients. In addition,stress levels increase between embryo transfer and pregnancy test, during this waiting period. The investigators evaluated whether or not brief interventions by phone by trained social workers influenced stress levels. Our data showed that these interventions did not change levels, but confirmed that stress did increase during this time and that patients report wanting additional emotional support to improve stress during this period.


Eligibility Criteria:
Inclusion Criteria:

* All women (ages 18-45) undergoing their first fresh cycle of IVF using autologous oocytes where an embryo transfer occurred

Exclusion Criteria:

* \> 2nd cycle of IVF IVF using donor eggs or a gestational carrier
* Transfers with Cryopreserved embryos
* Day 5 embryo transfers
* Self-reported history of depression or anxiety
* Already seeing a mental health professional
* Inability to speak or read English
Rapid Evaluation of Acute Kidney Injury With NGAL in Acutely Ill Patients in the ICU

This is a multi-center, prospective, observational study of patients that are admitted to the intensive care unit (ICU). This study does not include any treatment or intervention and it is considered Nonsignificant Risk.

The study will be conducted in two phases. Phase One is specimen acquisition and subject diagnosis adjudication. Phase Two is biomarker testing.

Phase One

Approximately 850 adults admitted to general ICUs will be enrolled within 12 hours of receipt of ICU admission orders. Study specific whole blood and urine specimens will be collected.

There is an Adjudication Committee for this study. This committee is comprised of qualified, board-certified nephrologists.

Phase Two

During Phase Two, the plasma specimens will be divided amongst three clinical sites representative of the intended end users of this assay, and tested under a separate testing protocol.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 21 years of age or older.
* Subjects must be admitted to an Intensive Care Unit (medical or surgical) and must be enrolled into this study within 12 hours of receipt of ICU admission orders.
* Subjects must be assessed as likely to be alive in the ICU for a minimum of 48 hours after enrollment.
* The following plasma/serum creatinine values must be available:
* Subjects that are admitted to the ICU following an elective surgery or procedure must have at least one pre-surgical/ pre-procedure creatinine value obtained in the 7 days prior to presentation to the ICU.
* Subjects that are admitted to the ICU for any reason other than following an elective surgery or procedure must have at least one creatinine value obtained greater than 7 days and up to 6 months prior to presentation to the ICU.

Exclusion Criteria

* Subjects either receiving or in imminent need of Renal Replacement Therapy.
* Subjects with evidence of chronic kidney disease stages 4 and 5 as evidenced by a pre-enrollment estimated GFR of less than 30 mL/min/1.73M2 (according to the 4-variable MDRD22).
* Subjects with any obstructive uropathy at the time of presentation to the ICU.
* Subjects with any known urothelial, urological or kidney malignancies.
* Subjects that have had any urologic procedure or surgery immediately prior to admission to the ICU.
* Subjects that have had any renal transplant or nephrectomy.
* Subjects that have had cardiovascular surgery involving cardiopulmonary bypass within the previous 7 days.
* Subjects that have participated in an interventional clinical study within the previous 30 days including studies with any investigational and non-investigational drugs.
* The inability to obtain written Informed Consent from the subject or an authorized representative.
* Subjects that have been previously enrolled in this study during a prior admission to the ICU.