cyrilzakka/clinical-trials huggingface dataset:
Mothers Living With HIV and Their Adolescent Children

* Context: Mothers living with HIV (MLH) and their children face predictable challenges: maintaining physical and mental health, parenting while ill, and addressing HIV-related stressors.
* Objective: To evaluate the efficacy of a family-based intervention over time; to contrast the life adjustments of HIV-affected families and their non-HIV-affected neighbors in the current treatment era.
* Design: Randomized controlled trial of MLH and a longitudinal comparison of MLH to a neighborhood cohort using random effect regression.
* Participants and Intervention: MLH (n = 339) and their school-age children (n = 259) were randomly assigned to receive 1) an intervention of 16 sessions in a cognitive-behavioral, small-group format; or 2) control. MLH and their children were compared to non-HIV-affected families recruited at shopping markets. Participant retention was high: 84% at 6 months, 83% at 12 months, and 78% at 18 months.
* Main Outcome Measures: Family functioning and conflict, mental and physical health, sexual behavior, and substance use.


Eligibility Criteria:
Inclusion Criteria for Intervention/Control, mother living with HIV:

* Mother or primary female caregiver
* Enrolled in HIV-related clinical cares
* At least one child between the age of 6 and 20 years

Inclusion Criteria for neighborhood control, non-HIV-affected mother:

* Mother or primary female caregiver
* not HIV-positive
* At least one child between the age of 6 and 20 years

Exclusion Criteria (Intervention/Control/Neighborhood):

* Mother less than 18 years old
* Unable or willing to give informed consent
* Psychosis or neurological damage as judged by the investigator in consultation with clinical supervisor
Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma

This phase II trial studies how well stem cell transplant with or without tbo-filgrastim works in treating patients with multiple myeloma or non-Hodgkin lymphoma. Eliminating the use of tbo-filgrastim after transplant may still help maintain a similar time to discharge.

PRIMARY OBJECTIVE:

I. To demonstrate non-inferiority in the number of days to discharge readiness after a granulocyte colony-stimulating factor (G-CSF) + plerixafor-mobilized autologous stem cell transplant in patients receiving versus not receiving post-transplant growth factor support.

SECONDARY OBJECTIVE:

I. To compare days to absolute neutrophil count (ANC) \> 500, days to platelet engraftment, febrile days, days of febrile neutropenia, documented infections, and number of antibiotic days in patients receiving versus not receiving post-transplant growth factor support.

EXPLORATORY OBJECTIVE:

I. To evaluate immunological recovery (lymphocyte number including CD 3/4 and CD3/8 T cell subsets) at day + 60 in patients receiving versus not receiving post-transplant growth factor support.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing autologous stem cell transplant for one of the following diagnoses:

  * Multiple myeloma
  * Non-Hodgkin lymphoma
* Karnofsky performance status of \>= 70%
* Patients must meet the Thomas Jefferson University Hospital (TJUH) bone marrow transplant (BMT) standard of procedure (SOP) guidelines for "Patient Criteria for Autologous HSCT"
* Left ventricular ejection fraction (LVEF) of ≥ 40%
* Adjusted Carbon monoxide diffusing capability (DLCO) \> 45% of predicted corrected for hemoglobin
* Serum bilirubin \< 1.8
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 2.5 X upper limit of normal
* Serum creatinine =\< 2.0 mg/dl and/or creatinine clearance of \> 40 ml/min (excludes multiple myeloma patients receiving high dose melphalan conditioning)
* Willingness to use contraception if childbearing potential
* Has the ability to give informed consent, or for cognitively or decisionally impaired individuals (vulnerable population), the availability of a family member or guardian to give consent and assist in the consent process
* Life expectancy of \> 12 months (exclusive of the disease for which the auto HSCT is being performed)
* Patients must have undergone stem cell mobilization with the combination of G-CSF and plerixafor as per TJUH BMT SOP guidelines
* Collection of an adequate number of CD34+ stem cells, i.e. \>= 4-6 x 10\^6/kg from apheresis

Exclusion Criteria:

* Uncontrolled human immunodeficiency virus (HIV)
* Uncontrolled bacterial infection
* Active central nervous system (CNS) disease
* Pregnancy or lactation
* Evidence of another malignancy, exclusive of a skin cancer that requires only local treatment
Pharmacokinetics of Patupilone After a Single Intravenous Administration in Patients With Advance Solid Tumor Malignancies.

The main purpose of this study is to characterize the distribution, metabolism, and elimination (ADME) of Patupilone after a single intravenous administration in patients with advanced solid tumor malignancies


Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. World Health Organization (WHO) Performance Status Score of: 0- you are fully active and more or less as you were before your illness, 1 - you cannot carry out heavy physical work, but can do anything else.
3. Adequate hematological laboratory parameters
4. No major impairment of renal or hepatic function
5. Female patients must have a negative serum pregnancy test at screening.

Exclusion Criteria:

1. Severe and/or uncontrolled medical disease;
2. Severe cardiac insufficiency with uncontrolled and/or unstable cardiac or coronary artery disease;
3. Known diagnosis of human immunodeficiency virus (HIV) infection;
4. Presence of any other active or suspected acute or chronic uncontrolled infection;
5. Symptomatic brain metastases or leptomeningeal disease.

Other protocol-defined inclusion/exclusion criteria may apply.
Saga Stories in Health Talks in Primary Child Healthcare

Primary child healthcare in Sweden is an important arena for health promotion interventions as nurses regularly meet parents and children from birth to five years of age. To date there is a lack of evidence-based material for child healthcare nurses to use in health promotion talks within primary child healthcare. Therefore, the aims of this study are to: (i) evaluate the effectiveness of Saga Stories in health talks on parental self-efficacy to promote healthy diet, physical activity, and screen time behaviours in 5-year-old children and (ii) evaluate the implementation of Saga Stories in health talks with regards to acceptability, appropriateness, feasibility, fidelity, adoption, sustainability, satisfaction, and usage.


Eligibility Criteria:
Inclusion Criteria:

* The parent the accompanies the child to the 5-year check-up at primary child healthcare needs to be able to understand Swedish sufficiently well in order to provide informed consent and partake in the Saga Stories health talk.

Exclusion Criteria:

* None
NK-ORB Expression of Mu Receptor on Lymphocytes in Rehabilitation

Chronic pain is a serious disorder that causes physical suffering and emotional distress.

NK cells are cytotoxic granular cells playing a crucial role in innate immunity.

Recent studies described modulation of the percentage of B lymphocytes and NK cells expressing the μ opioid receptor as a potential marker for measuring pain. Neuropathic pain sufferers have decreased NK cell function, highlighting the need of further investigating the effect of opioid receptor expression on lympoid cells defining their potential relevance as a pain monitor marker. Opioid receptors expressed on NK, B and T cells are a possible candidate for objective monitoring of pain in patients.

Pain is a serious global problem Based on the preliminary data, peripheral blood of pain suffering patients who have entered a neurorehabilitation program will be investigated to confirm the modulation of the percentage of Mu-positive NK cells and to evaluate if they could be eligible as predictive markers of chronic pain.

All patients in the experimental group will undergo three blood sample collections at specific time points to evaluate the percentage of Mu-positive NK cells, and its modulation according to rehabilitation programs: the day of the enrollment (T0), at half part of the neuro rehabilitation programs (T1) and at the end of neuro-rehabilitation programs (T2). Particularly, the two study groups involved will be in a experimental group (50 consecutive patients who have an NRS \>5); a control group (50 patients who have an NRS \<5).

Peripheral blood will be incubated with different fluorochrome-conjugated antibodies, specific for natural killer cells, in combination with anti-Mu Opioid Receptor (MOR) and the data will be analyze usin flow cytometer and FlowJo. The level of statistical significance will be fixed at p \< 0.05. Analyses will be carried out using GraphPad Prism software (v8.00; GraphPad Software). The results are expressed as mean ± SEM The expected results from this study could support the hypothesis that modulation of the µ opioid receptor on NK cells is a valid method for pain measurement, helping to establish an innovative approach in a rehabilitation program.

Eligibility Criteria:
Inclusion Criteria:

IRCCS San Raffaele Roma patients who entered the neuro-rehabilitation program, aged 18 years older, able to sign a written informed consent.

Exclusion Criteria:

* Patients with oncological or psychiatric diseases.
* Pregnant patients
* Patients with a severe psychiatric disorder (excluding mild depression) or mental/cognitive impairment
Evaluating Barriers to Stroke Screening and Prevention in Children With Sickle Cell Disease

DISPLACE is a three part, multi-center U.S. based study to evaluate the barriers to stroke screening and prevention in children with sickle cell anemia (SCA). In the United States, TCD (Transcranial Doppler ultrasound) is a proven method of screening children with SCA for stroke. However, many children are not getting the screening they need. This study will examine the issues that hinder and help children get the screening at 28 different hospitals and sickle cell centers to improve care for all children with sickle cell anemia. The investigators will then plan a study (part 3) aimed to improve stroke screening and prevention in sickle cell anemia.

DISPLACE (Dissemination and Implementation of Stroke Prevention: Looking At the Care Environment) is a multi-center, national NHLBI-funded grant to evaluate the real world implementation of the STOP protocol in which transcranial Doppler (TCD), a measure of cerebral blood vessel velocity, is used to screen for stroke risk in children ages 2-16 with sickle cell anemia (SCA). Based on the STOP (Stroke Prevention Trial in Sickle Cell Anemia) protocol, children identified as high risk of stroke by TCD are initiated on chronic red cell transfusion therapy (CRCT) for stroke prevention. Children with normal TCD are screened annually from the age of 2 until they are 16 years of age.

This will be a THREE-part study beginning with Part 1 - a retrospective case record review followed by Part 2 - a multi-level qualitative assessment of barriers and enablers to TCD screening and initiation of chronic red blood cell transfusions and later adding Part 3 - a multi-center implementation clinical trial.The investigators will compare two implementation interventions to improve TCD screening.

There are three aims of the grant and each aim is equivalent to the respective parts of the grant (i.e. Part 1 covers 1 aim). There are a total 28 consortium sites. The Medical University of South Carolina is the lead institution for this study.

Eligibility Criteria:
Inclusion Criteria:

* Age is \>2 and \<16 at time of review (from 2012-2016)
* have documented sickle cell anemia
* primary language is English
* patient at a DISPLACE consortium institution

Caregiver Characteristics:

Parent or guardian of patient who meets above criteria Primary language is English Has the cognitive capacity to complete questionnaires

EXCLUSION CRITERIA:

Child Characteristics:

Experiencing current acute complications of sickle cell disease requiring hospitalization or an acute care visit (e.g., pain crises, acute chest syndrome, acute cerebrovascular events/stroke or active infection/fever)

Caregiver Characteristics:

Has a child experiencing current acute complication of sickle cell disease, such as pain crisis, acute chest syndrome, stroke, or infection.
INVSENSOR00027 Fall Detection Clinical Performance Study

This study assesses INVSENSOR00027's clinical performance for fall detection.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 45 years old
* Physical status of ASA I or II
* Subjects must be able to read and communicate in English
* Has signed all necessary related documents, e.g. written informed consent, volunteer payment form, confidentiality agreement
* Has completed Health Assessment Questionnaire and passed health assessment screening

Exclusion Criteria:

* Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study
* Inability to tolerate physical activities including jumping and fall simulation
* Nursing female volunteers
* Excluded at the Principal Investigator's discretion
* Refusal to take the pregnancy test (for female subjects)
* Positive pregnancy test for female subjects of child bearing potential. This is done for the safety of this population.
* Refusal to shave hair (chest) off areas where sensors will be applied (male subjects)
Repeat Ivermectin Mass Drug Administrations for MALaria Control II

RIMDAMAL II is a double-blind, cluster randomized trial in Burkina Faso designed to test whether repeated ivermectin mass drug administrations, integrated into a monthly delivery platform with standard malaria control measures of seasonal malaria chemoprevention and insecticide-treated bed net distribution in the Sahel, will reduce childhood malaria incidence.

The RIMDAMAL II trial is designed to determine the efficacy of adding seasonal ivermectin mass drug administrations to the standard-policy malaria control measures in the Sahel (seasonal malaria chemoprevention in children, maximum long-lasting insecticidal net coverage, intermittent preventive treatment in pregnancy), for reducing the incidence of uncomplicated malaria episodes in enrolled village children (≤ 10 years of age) assessed by active case surveillance. The investigators will also examine the safety of the intervention, as well as entomological and parasitological endpoints. This is a double-blind, cluster randomized trial in that will occur in villages in southwestern Burkina Faso over two consecutive rainy seasons. For the intervention, mass administration of ivermectin or placebo will be given monthly over 4 months of each rainy season to the eligible village population, each as 3-day course of 300 µg/kg/day. These mass drug administrations will occur simultaneously with the distribution of seasonal malaria chemoprevention drugs on the same monthly schedule to eligible children aged 3-59 months.

Eligibility Criteria:
Inclusion Criteria (for being enrolled in the study):

* Residence in selected study village
* Able to understand the information and willing to give consent or assent (age 12-18) and parent/guardian consent if study participant age is \< 18 years of age.

Exclusion Criteria (for participating in the intervention \[ivermectin or placebo MDA\]):

* Residence outside of the study village
* Height \< 90 cm (\*note: if subject becomes ≥90cm over course the trial, this exclusion criteria will no longer be valid in subsequent MDA)
* Current treatment with SP+AQ as part of SMC (restricted to children 3-59 months old) (\*note: if subject discontinuous SP+AQ treatment because they become older than 59 months over course the trial, this exclusion criteria will no longer be valid in subsequent MDA)
* Permanent disability or serious medical illness that prevents or impedes study participation and/or comprehension
* Pregnancy (screened for in women of child-bearing age \[ages 15-45\] using a pregnancy urine rapid test \[e.g. SD Bioline hCG\] the week prior to each MDA)
* Breast feeding if infant is within 1 week of birth
* Known allergy to ivermectin
* Possibility of Loa loa infection as assessed by travel history to Angola, Cameroon, Chad, Central African Republic, Congo, Democratic Republic of Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria, and Sudan.
* Enrolled in any other active clinical trials
Short Versus Standard Intramedullary Nail for Trochanteric Hip Fractures

In England each year over 65,000 people fracture their hip. Most of these patients are elderly females with the fracture occurring after a simple trip or stumble. Approximately half of these fractures are classified from their relationship to the hip joint capsule as extracapsular. The majority of these fractures are treated surgically by internal fixation using, either a plate and screws (sliding hip screw) or nail and screws (intramedullary nail).

Recent randomised studies from Peterborough involving 1000 patients have indicated that there are modest benefits for treating this type of fracture with an intramedullary nail in comparison to a sliding hip screw. This study aims to progress from these earlier studies to determine if a slightly thinner and shorter intramedullary nail (175mm in length), has any significant advantages or disadvantages to the standard length (220mm) intramedullary nail.

Both implants to be used in this study are in routine use around the world and are being used within their licenced indication. The study is therefore using two different designs of implant within their recommended area of use, but in which there is uncertainty as to which is the best design.

The trial will be run as close to the ideal trial methodology for a randomised trial as specified by the CONSORT statement as possible. This will include secure randomisation, intention to treat analysis, full reporting of outcomes and clinical follow-up by a person who is blinded to the prosthesis used. The trial will follow the code of good clinical practice as specified by the hospital trusts Research and Development Committee.

In Peterborough all hip fracture patients are admitted to the acute trauma ward and transferred to the care of the Chief Investigator (Mr Martyn Parker (MJP)). Those patients that are willing to participant in this randomised trial are consented prior to surgery. Treatment follows standard evidence based protocols with follow-up of all patients in a hip fracture clinic. A comprehensive database is maintained for all patients containing both audit and research data. Included in this is a standardised assessment of outcome.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to Peterborough City Hospital with a trochanteric hip fracture (type A1 type A2) that is to be treated by internal fixation with an intramedullary nail.

Exclusion Criteria:

* Patients who decline to participate or in whom consent or assent is not available

  * Patients admitted when MJP is not available to supervise treatment
  * Patients with pathological fractures from Paget's disease of bone secondaries from tumour
  * Patients with a Subtrochanteric fracture and those of the reversed and transverse fracture type (A3 fractures)
Ezetimibe and Statins on Postprandial Lipemia in Type 2 Diabetes

The purpose of this study is to determine whether ezetimibe in association with statins is more effective than statins alone on postprandial lipemia in type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes since at least two years
* Stable metabolic control (HbA1c\<8.0%) for at least six months on diet or diet+oral hypoglycemic drugs (insulin secretagogues or metformin), not to be changed during the study period.
* BMI\<30 kg/m2 and body weight stable during the last six months.
* Both sexes; only post-menopausal women.
* LDL-cholesterol \>130 mg/dl, plasma triglycerides \<400 mg/dl.
* No use of hypolipidemic drugs in the last three months.

Exclusion Criteria:

* Patient with renal (serum creatinine \>1.5 mg/dl) or hepatic (serum transaminases \>three times upper normal values) impairment.
* Patients with history of cardiovascular disease.
* Pre-menopausal women.
* Any other acute or chronic degenerative disease.
* Anemia (Hb\<12 g/dl).
* Uncontrolled blood pressure.
* Use of any drugs able to interfere with the study medications
Turner Syndrome Prenatal Diagnosis Study

The goal of this study is to compare the features of Turner syndrome in girls who are diagnosed before birth because of fetal concerns versus those who are diagnosed when their mother has an amniocentesis for another reason.

This is an observational study which will look at girls who are diagnosed with Turner syndrome before they are born. Girls will be divided into two groups: 1) those diagnosed because of features seen on ultrasound which raised the question of Turner syndrome and 2) those diagnosed incidentally when their mother had an amniocentesis for another reason such as advanced maternal age.

No clinical procedures nor interventions will be done as part of this data collection study which will occur for the first 3 to 6 years of the girl's life. The investigators will be looking to see if girls who are diagnosed incidentally have less features of Turner syndrome than those girls who are diagnosed because of fetal ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Turner syndrome diagnosed prenatally
* Less than 4 months of age at time of enrollment

Exclusion Criteria:

* Turner syndrome diagnosed postnatally
* Older than 4 months of age at time of enrollment
The New Golden Standard: the Early Warning Score Algorithm

The objective is this study is the development and implementation of a smart algorithm to compute an early warning indicator able to predict early patient deterioration.

Data will be collected at the three sites using the SomnoTouchTM and MOXTM devices, commercially available and CE approved. Every month, the data will be sent to the KUL and UM to develop the algorithm. Study centers will also send some pre-defined patient characteristics extracted from the patient's EMR to better contextualize the data.

The EWS formula has a free interpretation of the vital parameters weighting and the vital parameters to be taken into account in the scoring system. Therefore, many variants of the EWS arose the past decade (i.e. MEWS, NEWS). The algorithm developed in this study should define an objective approach for the EWS formula, diminishing the discordances regarding the weight per parameter. Using a patient-personalized approach, the definite algorithm should be based on the patient's vital parameter measured during his/her whole hospitalization, generating a patient-personalized weight per parameter and an overall reliable EWS scoring system.

The EWS score is often only measured twice per day per patient, creating a large window for disease worsening. The algorithm developed in this study could be deployed along the wearable device developed in the WearIT4Health project. The device would continuously feed the algorithm with data acquired from its sensors. Thus, the EWS would be computed every 10 seconds.

The EWS scoring system has already been proven to be an effective approach in reducing clinical deterioration, reducing the admission to intensive care units and thus overall reducing mortality. However, as mentioned above the EWS is measured in a rather low frequency. Therefore, estimation of the EWS score via continuous monitored parameters should further increase patient survival.

The primary objective of the EAGLE study is to collect continuously monitored vital and activity parameter data and use it to develop an algorithm that can early identify clinical deterioration to optimize the application of the EWS system.

Eligibility Criteria:
Exclusion Criteria:

* Suffering from infectious disease
* Participating to another study that could intervene with the study results (e.g. experimental medication that could affect the heart rate).