cyrilzakka/clinical-trials huggingface dataset:
ICON1: Treatment Decisions and Outcomes in Pediatric Refractory ITP

The purpose of this study is to understand physician treatment decisions in selecting specific second line treatments in pediatric ITP and to determine the effectiveness of different second line ITP treatments. Eligible patients are those ages 1-18 years who are starting on a new second line treatment for ITP, defined as any treatment other than IVIG, steroids, anti-D globulin, or aminocaproic acid. Enrolled patients remain on the study for approximately one year.

The purpose of this observational study is to model factors that determine physician treatment decisions in selecting specific second line agents in pediatric ITP and to determine the comparative effectiveness of second line ITP treatments by bleeding measures, platelet counts, and patient reported outcome measures. This prospective observational, longitudinal, multicenter cohort study will aim to collect routine clinical care data, quality of life information from patients, and decision making data from clinicians at enrollment and at regular clinical intervals for at least one year. The primary and secondary objectives are as follows:

Primary Objectives:

1. To model factors that determine physician treatment decisions in selecting specific second line agents in pediatric ITP.
2. To assess patient reported outcomes with relation to specific second line pediatric ITP therapies.
3. To determine the comparative effectiveness of second line ITP treatments in terms of bleeding and platelet counts.

Secondary Objectives:

1. To describe phenotypic variation among patients with refractory ITP;
2. To assess side effects and complications related to specific treatments for refractory ITP;
3. To describe monitoring and follow up practices among pediatric hematologists with each second line agent;
4. To weight factors that physicians use when deciding to treat pediatric ITP patients with second line agents;
5. To determine whether physician perception of patient quality of life correlates with patient derived quality of life measures;
6. To measure the correlation between the ITP Bleeding Scale and the Bleeding Assessment Tool in refractory pediatric ITP patients.

Eligibility Criteria:
Inclusion Criteria:

* Immune Thrombocytopenia or Evans Syndrome
* Ages \> 12 months to \<18 years
* Starting a new second line therapy as defined as any therapy except IVIG, steroids, anti-D globulin, or aminocaproic acid
* Starting a single agent/monotherapy

Exclusion Criteria:

* Evans Syndrome with a history of or current evidence of autoimmune hemolytic anemia
* Unwillingness to be followed for 1 year
* Physician providing care is unwilling to participate
* Patient is starting multiple second line agents simultaneously
Prevalence and Prognostic Relevance of Tricuspid Regurgitation in Different Heart Failure Entities

The present study includes patients with tricuspid regurgitation and heart failure diagnosed with echocardiography. The aim is to evaluate the physical performance of patients with tricuspid regurgitation and heart failure, to observe the course of the diseases and to allow a better understanding of new therapy options.

Moderate to severe tricuspid regurgitation (TR) is a frequent result of left heart failure causing a limiting prognosis. The new interventional therapies have given more relevance to the questions of the prognostic significance of severe TR in the various heart failure entities.

Important but currently unanswered questions for the establishment of successful, interventional therapies of TR are:

1. What effect does TR have on patients with heart failure?
2. Which patients at which stage of the disease benefit from interventional TR-therapies? In order to answer these questions, the aim of the study is to prospectively record the prevalence of TR (including quantification) in all heart failure patients at the Charité, followed by long-term observation to assess its prognostic relevance.

In addition to answering the above-mentioned questions, the project will allow a central registration of all symptomatic heart failure patients. A comparative outcome analysis per propensity score matching with the untreated patients of the registry would allow to give first considerations which patients are ideal candidates for interventional therapies.

Primary endpoint: death Secondary endpoint: hospitalization due to cardiac decompensation, exercise capacity according to NYHA classification

Eligibility Criteria:
Inclusion Criteria:

* Patients with transthoracic echocardiography (TTE) and heart failure
* Reported heart failure symptoms within the last two years
* \>18 years
* Written, documented consent

Exclusion Criteria:

- Patients in care or unable to consent
The PK/PD, Efficacy, Safety and Tolerability Study of SHR3824 in Combination With Metformin in Type 2 Diabetes Mellitus Patients

The purpose of this study is to evaluate the efficacy and safety of 3 different doses of SHR3824 compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of type 2 diabetes mellitus;
* Hemoglobin A1c levels \>=7.5% and \<=10.5%;
* Body mass index (BMI) 25 to 45 kg/m2;
* Patient either has been treated with metformin for more than 8 weeks with dose more than 1500mg/day.

Exclusion Criteria:

* Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, Cushing's syndrome, etc.);
* Past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage III or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy);
* Systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg on the start or end day of the run-in period;
* History of myocardial infarction, unstable angina, or cerebrovascular disorder within 6 months before the start of the run-in period;
* Past or current history of malignant tumor;
* Past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;
* Pregnant women, lactating mothers, or women of childbearing potential;
* Any condition that subjects are assessed to be ineligible by the investigator (sub investigator).
Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)

The purpose of this study is to provide long-term safety data for rivastigmine capsule and transdermal patch treatments, in particular the effect of rivastigmine on worsening of the underlying motor symptoms of Parkinson's Disease (PD), in patients with mild to moderately severe dementia associated with PD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's disease, according to the UK Parkinson's disease Society Brain Bank criteria
* Diagnosis of Parkinson's disease dementia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, with onset of symptoms of dementia at least 2 years following the first diagnosis of idiopathic Parkinson's disease
* Mini Mental State Examination score of ≥10 and ≤ 26 (at Screening Visit only)

Exclusion Criteria:

* An advanced, severe, or unstable disease of any type that may interfere with the primary and secondary variable evaluations
* A score of 5 (wheelchair bound or bedridden) in the "on"-state on the Modified Hoehn and Yahr Staging (UPDRS Part V)
* A current diagnosis of any primary neurodegenerative disorder other than idiopathic PD
* A current diagnosis of any treatable dementia (hypothyroidism, syphilis, vitamin B12 or folate deficiency) that is verified by the investigator to be the cause of dementia.
* A current diagnosis of probably vascular dementia according to the National Institute of Neurological Disorders and Stroke and the Association International pour la Recherche et l'Enseignement en Neurosciences (NINDS-AIREN) criteria
* A current diagnosis of a major depressive episode according to DSM-IV criteria
* A history of stereotaxic brain surgery for Parkinson's disease
* A known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar to rivastigmine or to other cholinergic compounds

Other protocol-defined inclusion/exclusion criteria may apply.
Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients

Hyperparathyroidism (HPT) is common in people with a kidney transplant. Patients with HPT often have high parathyroid hormone (PTH) levels and may have large parathyroid glands in the neck. Patients with HPT can develop bone disease (osteodystrophy). This bone disease can cause bone pain, fractures, and poor formation of red blood cells. Other problems from HPT may include increases in blood levels of calcium (hypercalcemia) and low blood levels of phosphorus (hypophosphatemia). The high calcium levels may cause calcium to deposit in body tissues. Calcium deposits can cause arthritis (joint pain and swelling), muscle inflammation, itching, gangrene (death of soft tissue), heart and lung problems or kidney transplant dysfunction (worsening of kidney transplant function). The purpose of this study is to evaluate the effects of cinacalcet (Sensipar/Mimpara) on high calcium levels in the blood in patients with HPT after a kidney transplant.


Eligibility Criteria:
Inclusion Criteria:

* Received a kidney transplant ≥ 9 weeks at time of Screening and ≤ 24 months before first dose
* May be the first kidney transplant or a repeat kidney transplant.
* Subjects with a functional, stable kidney transplant, defined as MDRD estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m² (chromic kidney disease stage 3 or better) at Screening.
* Men or women ≥ 18 years at the start of Screening (ie, time of informed consent).
* Corrected total serum calcium \> 10.5 mg/dL (2.63 mmol/L), defined as the mean of 2 values in Screening period.
* iPTH \> 100 pg/mL (10.6 pmol/L), during the Screening period (obtained at either Screen 1 or Screen 2).

Exclusion Criteria:

* Received cinacalcet therapy post-transplant for more than 14 days cumulatively post-transplant. If cinacalcet therapy was received for a total of 14 days or less post-transplant, there must be a 4-week washout before subject is eligible for screening (Note: This does not exclude pre-transplant use of cinacalcet).
* Anticipated parathyroidectomy within 6 to12 months after Randomization.
* Ongoing therapy with bisphosphonates or use within 6 months prior to Screening.
* Ongoing use of 1,25-dihydroxyvitamin D3 (including other active vitamin D metabolites or analogues) or use within 30 days prior to Screening.
* Ongoing use of calcium supplements or use within 30 days prior to Screening.
* Ongoing use of phosphate binders (calcium or non-calcium containing) or use within 30 days prior to Screening.
* Ongoing use of a thiazide diuretic.
* Subjects with a history of seizures who had a seizure within the 3 months prior to Randomization, which required adjustments to the seizure medication.
* Acute Kidney Injury (AKI) or renal biopsy within 6 weeks prior to Screening, unless it is an institutional protocol-driven biopsy.
Impact of Availability of Showerpatch for Patients With Intravenous Catheters

Venous catheters are necessary for the treatment of many patients. Showering with a venous catheter is often prohibited due to the infection risk when the insertion site becomes wet. Therefore these patients are challenged to keep the catheter insertion site dry and always covered with a dressing. Washing themselves is often impossible without assistance of a nurse or significant other. For patients with a catheter connected to an infusion line, it is even more difficult. Showerpatch is a newly developed dressing that safeguards the insertion site of an IV catheter from water during bathing activities. The purpose of this trial is to evaluate the impact of the availability of Showerpatch by comparing the outcomes in patients regarding the patient's autonomy in bathing activities, the material use and the time needed from caregivers in home care. Additionally qualitative data on patient's bathing activities and the use of Showerpatch will be collected.


Eligibility Criteria:
Inclusion Criteria:

* able to read and speak Dutch and to fill out a web-based questionnaire
* patients with an IV catheter (peripheral catheter, midline, peripherally inserted central catheter (PICC), Central Venous catheter (CVC), tunnelled catheter or implantable port) with an expected dwell time IV therapy of at least 14 days and with or without a prospect of discharge to the home setting with the IV catheter in situ in the foreseen study period
* physically able to wash themselves
* with access to the internet

Exclusion Criteria:

* Bedridden patients
* Patients who have already participated in an earlier stage of the ISIC study
* Patients with more than one lumen of the catheter continuously connected to an infusion line
Precision-Based Approach to Matching Evidence-Based Interventions to Students With Externalizing Behaviors

Although prevalent across schools in the US, the "One-Size-Fits-All" (OSFA) approach to selecting evidence-based interventions (EBIs) for student externalizing behaviors often yields lackluster outcomes, due to the mismatch between the EBI and students' heterogeneous needs. Emerging literature highlighted the promise of the precision approach to intervention (e.g., Student Intervention Matching System; SIMS), whereas EBIs were selected based on the match between a student's individual needs and the active components of EBIs. This pilot study tested the efficacy, feasibility, and acceptability of SIMS to match EBIs to students with externalizing behaviors. The investigators ran a double-masked randomized waitlist-controlled trial in a diverse urban district. Students at risk for externalizing behaviors were recruited and randomly assigned to the treatment (EBIs matched via SIMS) or control condition (mismatched social-skill training). Students received EBIs based on assigned condition for 10 weeks. Students' externalizing behaviors were assessed via a multi-method approach at baseline and 10-week posttest. Teachers rated the feasibility and acceptability of SIMS at 10-week posttest. The investigators used cluster-adjusted ANCOVAs to compare efficacy of matched EBIs via SIMS against that of the mismatched social skill training in reducing student externalizing behaviors.


Eligibility Criteria:
Inclusion Criteria:

* with a moderate risk for externalizing behavioral problems, which was indicated by a score between 4 and 8 on the Student Risk Screening Scale-Externalizing.
* receiving the majority of services in general education settings
* in 3rd, 4th, or 5th grade level.

Exclusion Criteria:

* severe risk for externalizing problems, which was indicated by a score exceeding 8 on the Student Risk Screening Scale-Externalizing. The students at severe risk will be referred to the school counselor for appropriate service.
Campus Health Intervention Projects UBC Site

The goal of the study is to test the efficacy of brief physician advice in reducing the frequency of high risk drinking and alcohol-related harm in a population of university students seeking routine care at UBC Student Health Service. It is hypothesized that receiving the intervention will reduce the amount of alcohol consumed and the incidence of alcohol-related harm among the students in the intervention group, as compared to the control group.

We estimate that roughly 3000 students will need to be screened to obtain sufficient eligible participants to randomize 150 students. High-risk drinkers will be identified by means of an embedded alcohol screening survey, which will be distributed through Student Health Services. Those deemed eligible through the screening survey and who have agreed to be contacted will be invited to attend a baseline interview, which will further define eligibility and assign interested students to the control or intervention group. Those randomized to the usual care control group will receive a self-help health booklet and will be contacted to complete a follow-up telephone interview at 6, 12, 18 and 24 months. Those randomized to the intervention group will receive the same booklet and will meet with a Student Health Service physician. There will be two face-to-face meetings with the physician and two follow up phone calls by the physician. The physicians use a scripted workbook, diary cards and other materials designed to reduce alcohol use and the frequency of high risk drinking. Those in the intervention group will also be contacted to complete a follow-up telephone interview at 6, 12, 18 and 24 months. Outcome data will also be sought, with participants' permission, from campus organizations including Campus Housing, Security, the RCMP and the Registrar.

Eligibility Criteria:
Inclusion Criteria:

Full time students 18 and older; students seeking routine care at UBC Student Health Services; students who report high risk drinking in the last 28 days; students able to read and communicate in English

Exclusion Criteria:

Students graduating or leaving campus before the first intervention is complete; students who are acutely ill; students who are under 18 years; female students who are pregnant; students who are suicidal; students consuming more than 200 drinks in the past 28 days
Comparison of Nevirapine and Efavirenz for the Treatment of HIV-TB Co-infected Patients (ANRS 12146 CARINEMO)

The purpose of this study is to determine whether the use of Nevirapine in HIV patients already treated against tuberculosis by Rifampicin is as efficient and as well tolerated as Efavirenz.

Anti Retroviral Therapy (ART) reduces tuberculosis (TB) incidence in HIV-infected patients and reduces mortality among TB patients with deep immune suppression. The Fixed Drug Combination (FDC) nevirapine (NVP)-lamivudine-stavudine is the first line ART available for low-income countries. Rifampicin (RMP), due to its liver induction effect, reduces significantly NVP plasma concentration, raising concerns regarding the risk of resistance and subsequent treatment failure. Therefore, in co-infected patients, WHO recommends delaying ART or using efavirenz (EFV)-based ART. Although EFV is also reduced at lower level, longitudinal studies report good efficacy and safety when given concomitantly with RMP.

In low-income countries, poor access to EFV, contradiction during pregnancy and absence of FDC containing EFV lead to difficulties in HIV-TB treatment.

Despite 2 limited retrospective studies and a non-randomised prospective study, which report good virological response at 6 months in co-infected patients receiving NVP and RMP co-administration, existing data are too limited to change the recommendation.

The aim of the study is to compare, in terms of therapeutic efficacy and clinical safety, the nevirapine-based HAART to the standard efavirenz-based HAART, in HIV/TB co-infected patients receiving a rifampicin-based TB treatment.

The study will evaluate one year after TB treatment initiation, whether the HAART efficacy (virological outcome, death or lost of follow-up) induced by NVP-based HAART is non-inferior to those induced by EFV based HAART, in patients receiving concomitantly HAART and RMP-based TB treatment.

Eligibility Criteria:
Inclusion Criteria:

* Person HIV infected
* Aged of 18 years or more
* Signed informed consent
* New case of tuberculosis: patient who never received TB treatment or for less than 1 month
* Patients receiving rifampicin based TB regimen since 4 to 6 weeks
* CD4 cell count \< 250 cell/mm3 in the 4 weeks following the TB diagnosis
* Naïve of HAART
* For women of childbearing age, to have a negative plasmatic test for pregnancy and to accept to take a contraception or declare no wish of pregnancy in the coming year.

Exclusion Criteria:

* To have a positive plasmatic test for pregnancy
* Karnofsky score \<60%
* ALAT \> 4N (Hepatitis grade 3 or 4)
* Ongoing psychiatric pathology
* Refuse to participate in the study

Amendment :

* bilirubin \> grade 3
* any grade 4 clinical sign or biological result at time of inclusion
Radiotherapy for NSCLC to a Individualized MLD

Our group has shown in a modeling study that increasing the radiation dose to pre-specified normal tissue dose constrains could lead to increased TCP with the same NTCP. In a subsequent phase I trial, the investigators showed the safety of this approach. Here, the investigators want to investigate its efficacy in a prospective study in patients with stage I-III NSCLC, who are selected for radical radiotherapy

Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes to the following MLD (Mean Lung Dose):

* MLD=19 Gy when Fev1 and DLCO \> 50% of the predicted value
* MLD=15 Gy when Fev1 and/or DLCO 40-49% of the predicted value
* MLD=10 Gy when Fev1 and/or DLCO \<40% of the predicted value

Other dose-constrains: spinal cord max: 54 Gy, brachial plexus (Dmax):66 Gy Minimum tumor dose:79.2 Gy.

Radiotherapy will be delivered in twice-daily fractions of 1.8 Gy with 8 to 10 h as interfraction-interval, 5 days per week.

The radiation doses will be specified according to ICRU 50. Lung density corrections will be applied, as well as all standard QA procedures. Technical requirements are the same as in standard practice at MAASTRO clinic.

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological proven NSCLC
* UICC stage I-III
* Performance status 0-2
* FeV 1 and DLCO at least 30% of the age-predicted value

Exclusion Criteria:

* Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma)
* UICC stage IV
* Performance status 3 or more
* FeV 1 and DLCO \< 30% of the age-predicted value
Effect of Biodanza on Desire, Excitation and Sexual Inhibition

the objective of this study was to examine the effects of a 10 weeks biodanza program on the sexual desire and inhibition/arousal of a sample of healthy young adults.

A randomized clinical study was carried out, involving a total of 86 young adults divided into Intervention Group (BG) and Control Group (CG), carrying out biodanza sessions during 10 weeks. The Sexual Desire Inventory (SDI) and the Sexual Inhibition/Sexual Arousal-Short Form Scale (SIS/SES-SF) were completed before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* having correctly completed the online questionnaire.
* to attend a minimum of eight Biodanza sessions.

Exclusion Criteria:

* exceed 30 years old.
* the presence of some type of physical or mental disability that could prevent their participation in the therapy or the completion of the questionnaires.