cyrilzakka/clinical-trials huggingface dataset:
Amlodipine/Atorvastatin Combination to Reduce the Health Risk of High Blood Pressure and High Cholesterol Levels

The purpose of the study is to measure the effect of the amlodipine/atorvastatin combination pill in reducing both elevated blood pressure and cholesterol levels to levels suggested by guidelines


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of both elevated blood pressure and low density lipoprotein cholesterol levels, requiring medication

Exclusion Criteria:

* Patients with blood pressure adequately maintained at goal with or without medication
* Patients currently treated with both amlodipine and atorvastatin or not at blood pressure or lipid level while taking the highest dose of amlodipine or atorvastatin, respectively
A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)

The purpose of this study was to assess the safety and tolerability of ABBV-951 (Foslevodopa/Foscarbidopa) in participants with Parkinson's disease (PD).

This was a single-arm study with preplanned analyses conducted by dose subgroup (Low Dose or High Dose) based on the modal total daily dose (most frequent dose) over the treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Participants with diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa-responsive
* Participants must be judged by the investigator to be inadequately controlled by current therapy, have recognizable/identifiable "Off" and "On" states (motor fluctuations), and have a minimum of 2.5 hours of "Off" time per day

Exclusion Criteria:

* Participant is cognitively impaired and is not able to safely and effectively manage the drug delivery system and the diaries and is not able to adhere to the study
* Participant is considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason
S9031-S9126-S9333-S9500-A, Studying Bone Marrow and Blood Samples From Patients With Acute Myeloid Leukemia

RATIONALE: Studying samples of bone marrow and blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at bone marrow and blood samples from patients with acute myeloid leukemia.

OBJECTIVES:

* To determine whether the expression of previously identified acute myeloid leukemia (AML)-specific and age-associated genes have prognostic significance in adult patients with AML.
* To examine, preliminarily, if AML-specific and age-associated expression changes occur in the most primitive hematopoietic leukemia blasts (i.e., CD34+/38-).
* To examine, preliminarily, whether methylation or histone modification of the IRF8 CPG island/promoter region is correlated with IRF8 gene expression in AML.

OUTLINE: This is a multicenter study.

Previously collected specimens of RNA from pre-treatment marrow or peripheral blood are obtained from a repository of SWOG clinical trials (SWOG-S9031, SWOG-9126, SWOG-9333, and SWOG-9500). Samples are analyzed for absolute expression levels of 23 selected genes and relative expression levels of splice variants via quantitative RT/PCR and GeneScan assays and linked to clinical and outcome data from the main SWOG database. Samples from a subset of patients are analyzed to confirm aberrant expression of acute myeloid leukemia-specific and age-associated genes in highly enriched population of leukemic blasts (CD34+/CD38- and CD34+/CD38+). DNA samples are also analyzed for correlation of IRF8 gene expression with methylation or histone modification of the IRF8 CPG island/promoter region.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Pretreatment RNA specimens\* available from patients with acute myeloid leukemia (AML) registered for front-line therapy on the following clinical trials:

  * SWOG-9031
  * SWOG-9126
  * SWOG-9333
  * SWOG-9500
* Cryopreserved pretreatment cell specimens\* available from a subset of patients (those who obtained a complete response \[CR\] and remained in CR without relapse for ≥ 2 years vs those with resistant disease \[i.e., failed to achieve CR with evidence of persistent AML following induction therapy\]) NOTE: All specimens currently available in the Southwest Oncology Group Myeloid Leukemia and MDS Repository at the University of New Mexico

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Sleep in Women With Bilateral Salpingo-Oophorectomy

The purpose of this research study is the compare objective and subjective sleep characteristics in women who have undergone removal of both ovaries (bilateral salpingo-oophorectomy) before natural menopause compared to women who did not undergo this procedure.


Eligibility Criteria:
Inclusion Criteria:

* Women who participate in the parent SCORE studies (NCT03821857)

Exclusion Criteria:

* Night shift workers will be excluded
A Study of Mircera for the Treatment of Anemia in Dialysis Patients

This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* dialysis therapy for at least 2 weeks before screening.

Exclusion Criteria:

* women who are pregnant, breastfeeding or using unreliable birth control methods;
* administration of any investigational drug within 4 weeks before screening.
Climatotherapy At The Dead Sea For Atopic Dermatitis

The purpose of this study is to evaluate the improvement in severity of Atopic Dermatitis and quality of life after 4 weeks of treatment in the Dead Sea.

28 days treatment period, sun exposure and possibly Dead Sea baths after an exact given plan, discontinuation of all local Cortisone preparations, unlimited use of maintenance drags, doctor visit twice a week, continuous checks by the nurse.

Determination of the SCORAD index by the same doctor on arrival and departure. Before and after the treatment, the patient will answer written questionnaires regarding quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years old

Exclusion Criteria:

* Skin type - I
* Psoriasis patient in addition to Atopic Dermatitis
* Pregnancy
* Past malignancy
* Less then 2 weeks of treatment
The Effect of Dystonia Severity on Participation in Daily Living Activities and Caregivers in Children of Cerebral Palsy With Secondary Dystonia

Dystonia is the most common movement disorder in the pediatric population after spasticity. It can affect normal motor development and cause significant motor retardation. The presence of dystonia may affect motor function, pain, and ease of care in CP. Additionally, it can cause serious difficulties in daily living activities and social participation and long-term joint deformity. The increase in the severity of dystonia in CP children with secondary dystonia may affect the quality of life, activity and participation of the children, as well as the caregiver. The importance of caregivers is an undeniable fact, especially in these patient groups. This study aims to investigate the burden of dystonia severity on the participation in daily living activities and caregivers of children with CP with secondary dystonia.

It's an observational study. Purpose of the study: Investigating the burden of dystonia severity on the participation in daily living activities and caregivers of children with CP with secondary dystonia.

* Does dystonia severity affect participation in daily life activities in CP children with secondary dystonia?
* Does the severity of dystonia in children with CP with secondary dystonia affect the burden on the caregiver?
* Are the participation in daily living activities and caregiver burden of children with CP with secondary dystonia related to each other?

Total of 20 CP cases with secondary dystonia who applied to Acıbadem University Department of Pediatric Neurosurgery will be included in the study.

Dystonia severity of these cases will be evaluated with the Barry-Albright Dystonia Scale (BADS). Children's participation in daily living activities will be evaluated with The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD), and the burden on the caregiver will be evaluated with the Care and Comfort Hypertonicity Questionnaire (CCHQ).

Eligibility Criteria:
Inclusion Criteria:

* Total of 20 cases CP with secondary dystonia, aged between 3-15 years were included in the study.
* Obtaining voluntary consent from the family.

Exclusion Criteria:

* Having a surgical operation procedure on the musculoskeletal system.
* Receiving BoNT-A in the last 6 months.
PräVaNet - Structured, Intersectoral, Multiprofessional, Digitized Program to Optimize Cardiovascular Prevention

PräVaNet is a prospective, 1:1 randomized, controlled trial to investigate the efficacy of a new, digitalized prevention strategy ("ePrevention") in cardiovascular high-risk patients with type 2 diabetes mellitus in the outpatient sector.

PräVaNet is an interdisciplinary and digitally supported prevention concept based on a specialist online board, close patient care by a specially trained nurse, an E-Health platform with physician cockpit, patient App, a smart sensor kit (ECG-capable pulse watch, digital blood pressure monitor, digital blood glucose meter if required) and a telemonitoring/alarm system.

The aim of PräVaNet is to prevent a worsening of the condition of cardiovascular high-risk patients with type 2 diabetes through intensified and continuous risk factor monitoring as well as guideline- and needs-based patient treatment and care. Serious, cost-intensive (especially cardiovascular) secondary diseases are to be avoided and the quality of life of those affected is to be maintained or improved. PräVaNet includes intensive patient education to improve personal responsibility and self-management of the disease and the individual cardiovascular risk.

PräVaNet is the first clinical study evaluating effectiveness and safety of an ePrevention-concept in cardiovascular high-risk patients with type 2 diabetes mellitus in Germany.

Eligibility Criteria:
Inclusion Criteria:

Included are patients who at baseline:

* Are at least 18 years or older
* Living in the German federal states of Berlin or Brandenburg
* Insured by the cooperating German SHI company
* Diagnosed with type 2 diabetes mellitus at least 3 months prior to study entry and who
* Require drug therapy for diabetes mellitus type 2; i.e., received at least 1 oral antidiabetic drug or insulin therapy for at least 3 months prior to study entry; such a need for drug therapy should also exist at the start of the study for the next year and beyond

and

* Fulfill at least one of the following criteria:

  1. metabolic syndrome: 3 of the following 4 criteria: Waist-to-hip ratio (WHR) \> 94 cm/80 cm; triglycerides ≥ 150 md/dl or cholesterol- or lipid-lowering therapy; high density lipoprotein (HDL) \< 40/50 mg/dl or cholesterol- or lipid-lowering therapy; hypertension ≥ 135/85 mmHg or antihypertensive therapy;

     and/or
  2. macrovascular manifestations (coronary artery disease (CAD) and/or peripheral arterial disease (CAD) and/or carotid stenosis)

     and/or
  3. microvascular manifestation (chronic renal failure with estimated glomerular filtration rate (eGFR) \< 60ml/min/1.73m2).

     Exclusion Criteria:

     Patients with at least one of the following characteristics are excluded from participation:
* Chronic disease and, in this context, an anticipated life expectancy of less than 21 months;
* Renal failure requiring dialysis;
* Lipid metabolism disorder and indication for lipid apheresis;
* Mental illness requiring therapy;
* Lack of ability to use E-Health technologies;
* Participation in another intervention study.
Initial Assessment of an Internet-based Symptom Management Intervention in Early Stage Breast Cancer

In order to determine the acceptability of a breast cancer-specific cognitive behavioral therapy intervention, as well as to obtain preliminary data to assess efficacy in managing symptoms, the investigators will ask 45 breast cancer survivors with moderate insomnia, fatigue, and/or pain to use the investigators' internet-based intervention for 8 weeks and to complete patient-reported outcomes assessments before and after the 8 week intervention.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Stage 0-III invasive carcinoma of the breast
* Surgical resection and axillary assessment, radiation therapy, and/or chemotherapy, as indicated, completed at least 3 months prior to enrollment.
* Concomitant trastuzumab and anti-endocrine therapies are permitted. If taking anti-endocrine therapy must have been taking for at least 3 months prior to enrollment.
* Must report at least one of the following:

  1. Fatigue in the week prior to enrollment at least 4 on a 10 point scale (with 0 = not tired at all and 10 = extremely tired)
  2. Insomnia in the week prior to enrollment
  3. Pain in the week prior to enrollment at least 4 on a 10 point scale (with 0 = no pain and 10 = extremely severe pain)
* Has access to and is able to operate a computer with internet access.
* Able to read and understand English.
* Willing and able to sign an informed consent document.

Exclusion Criteria:

- Diagnosis of sleep apnea or restless leg syndrome that is currently interfering with sleep
Safety and Effectiveness of Giving Combinations of Three or Four Anti-HIV Drugs to HIV-Infected Patients

The purpose of this study is to see if it is safe and effective to give combinations of three or four anti-HIV drugs to HIV-infected patients. The drugs used in this study are delavirdine (DLV), nelfinavir (NLF), didanosine (ddI), and stavudine (d4T).

This is a multicenter, open-label study. Patients are stratified by HIV-1 RNA levels (20,000 to 200,000 copies/ml and greater than 200,000 copies/ml). Patients are equally randomized to one of four groups and receive antiretroviral therapy for 24 weeks. Group 1 receives delavirdine (DLV) plus nelfinavir (NFV) plus stavudine (d4T). Group 2 receives DLV plus NFV plus didanosine (ddI). Group 3 receives NFV plus d4T plus ddI. Group 4 receives DLV plus NFV plus d4T plus ddI. Patients are evaluated for drug safety and viral burden. Patients may opt to continue on the study for 24 additional weeks, at the discretion of the investigator.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are at least 18 years old.
* Are HIV-positive.
* Have a CD4 count of at least 50 cells/mm3.
* Have a viral load of at least 20,000 copies/ml.

Exclusion Criteria

You will not be eligible for this study if you:

* Have taken d4T.
* Have taken protease inhibitors, including NFV.
* Have taken nonnucleoside reverse transcriptase inhibitors.
* Have taken ddI for 1 month or more.
Blood Transplantation for Patients With Hematologic Malignancies or Bone Marrow Failure States

The purpose of this study is to assess early treatment failure within 100 days and to assess the effect of this regimen on engraftment, GVHD, immune recovery, relapse of malignancy and survival.


Eligibility Criteria:
* Patients with acute leukemia, lymphoma that failed to respond or relapsed after chemotherapy or CML beyond first chronic phase.
* Patients with aplastic anemia or myelodysplasia which failed to respond to primary therapy are eligible.
* Patients with low grade lymphoma or CLL will only be eligible if they failed two chemotherapy regimens and have stage IV disease.
* Patients must be \<age 50 with a related haploidentical donor (phenotypically one, two or three HLA A, B and DR antigen mismatched) donor.
* Patients should have adequate hepatic and renal function with a bilirubin of less than or equal to 1.5mg%, SGPT less than or equal to 3x the upper limits of normal, and creatine less than or equal to 1.5mg%.
* Patients with serious intercurrent medical illness are not eligible.
* Patients and their donors must provide written informed consent.
Identifying Functional and Psycho-social Complaints After Hospitalization for SARS-CoV-2 Infection( COVID 19)- REPERCOV

Since December 2019, China and then the rest of the world have been affected by the rapid spread of a new coronavirus infection called SARS-CoV-2 (severe acute respiratory syndrome coronavirus), the clinical expression of which is called Covid-19 (Coronavirus Disease 2019).

It is estimated that around 20% of symptomatic patients will be severe enough to warrant hospitalization, of which around 5% will be in intensive care.

Organ damage is multiple in Covid infection: respiratory, digestive, renal, neurological, cardiovascular due to the infection or its care. There is also a psychological and social impact of the infection or of the care that should be measured.

In this context, investigator will assess the physical and psychological complaints of patients who have presented a severe form of SARS-CoV-2 infection.

The final objective being to identify the needs to offer follow-up adapted to this emerging pathology.


Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized for severe Covid-19 infection between March 1 and June 30, 2020 in a conventional unit, intensive care unit, at the Centre hospitalier du Mans and alive at the time of the investigation at 2 to 3 months
* Patient having given their express consent, after having received the research information letter upon discharge from hospital or having given their express consent after sending the information letter
* Age ≥ 18 years
* Patient having contracted a SARS-CoV-2 infection proved by RT-PCR and / or retrospective serology and / or a Covid-19 syndrome with suggestive chest scanner (during the period from March 1, 2020 to June 30, 2020)

Exclusion Criteria:

* Patient opposition to participate in the cohort
* Non-French speaking patient
* Patients who cannot read or write
* Patient subject to a protective measure
* Patient not affiliated to a social security or equivalent health insurance
Microcirculatory Alteration and Biomarkers: New Approach for Early Assessment of Septic Multi-organ Dysfunction

The aim of this study is to investigate associations between early structural cellular injury and microvascular alteration with progression of septic organ dysfunction according to total SOFA-Score (an ICU-scoring system - the Sequential Organ Failure Assessment Score). Patients will be monitored for renal (TIMP-2, IGFBP7), and intestinal biomarkers (plasma i-FABP) in conjunction with kidney and muscle vascular bed microvascular perfusion analysis assessed by contrast-enhanced ultrasonography (CEUS). In parallel, a comprehensive analysis of patients' immunological status will be conducted using an established, on-site immune monitoring panel.

The ultimate goal of this study is an early identification of septic patients developing multiorgan dysfunction which may facilitate a timely novel intervention in the future to improve outcome.


Eligibility Criteria:
Inclusion Criteria:

Patients ≥18 years of age with severe sepsis and fulfill the following criteria at the admission to ICU:

* Peritonitis (abdominal infection) and performed source control (either surgically or interventionally)
* 2 or more criteria for systemic inflammatory response syndrome (temperature \>38° or\<36°; heart rate \>90 beats per minute; respiratory rate \>20 breaths per minute or paCO2 \<32 mmHg; white blood cell count \>12,000/mm3, \<4000mm3 or \>10% immature forms) and serum lactate level of 4mmol/l and more or refractory hypotension - mean arterial pressure \<65mmHg or systolic blood pressure \<90mmHg after fluid challenge of 1000ml or more /30min
* Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Written informed consent prior to any study procedures

Exclusion Criteria:

* Pre-existing renal-replacement therapy in the pre-operative course
* Pre-existing shock
* Acute coronary syndrome
* Active hemorrhage
* Trauma
* Known allergy to ultrasound contrast media
* Anemia with hemoglobin concentration \< 7g/dl
* Patients not able to give written informed consent
Rasburicase in Tumor Lysis Syndrome

The purpose of this study is to determine whether rasburicase is effective and safety in correcting hyperuricemia.


Eligibility Criteria:
List of inclusion Criteria:

* Acute hyperuricemia patients(uric acid\>8.0 mg/dl) before/during chemotherapy for hematologic malignancies.

List of exclusion Criteria:

* Hypersensitivity to uricases or any of the excipients.
* Known history of hemolytic anemia (G6PD deficiency).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
CAlming Touch for People With Agitation or Other Behavioural Symptoms of DEMentia - A Randomized Feasibility Trial

Dementia is an increasing health challenge among elderly citizens in Denmark. An estimated 87,000 Danes live with dementia, and this number is expected to increase to 130,000 in 2030. Psychiatric symptoms and behavioral changes decrease quality of life for patients and their spouses and is a challenge for caretakers. Behavior changes include agitation which can be divided in four sub-groups: 1) physical aggression, 2) physical non-aggression, 3) verbal aggression, and 4) verbal non-aggression. Pharmaceutical management of behavioral changes is common and may be associated with negative side-effects including drowsiness and falls. Though non-pharmaceutical interventions such as music, massage and social activities have been recommended the underlying evidence is limited. In this randomized feasibility trial, we will investigate the feasibility and acceptability of therapeutic touch aiming to reduce agitated behavior in people living with dementia in a nursing home that specializes in the care of people living with severe dementia.

The success criteria of this randomized feasibility trial are as follows:

1. Nursing home residents can be recruited and accept the treatment 'CAlming Touch for People with Agitation or Other Behavioral Symptoms of DEMentia' (CADEM) and complete the feasibility project's test protocol.
2. The treatment concept, which involves the nursing staff in charge of the follow-up treatment, can be implemented in practice.
3. The treatment (CADEM) shows a tendency towards less restless and aggressive behavior for demented citizens evaluated based on a validated measuring tool.


Eligibility Criteria:
Inclusion Criteria:

* Citizens who are residents of the care center due to dementia
* Citizens living at a care center in Naestved Municipality
* Demented citizens who exhibit agitated / aggressive behavior (nursing staff observe whether the citizen exhibits agitated behavior within at least one of the subgroups

Exclusion Criteria:

* Citizens in palliative care
* Citizens who have received BBAUM treatment within the last month
Activity Trackers for Monitoring During Rehabilitation After Total Knee Arthroplasty

This study aims to estimated the change of the steps of daily life of osteoarthritis patients before and in 6 weeks, 3 months, 6 months, 1 year after the total knee arthroplasty (TKA) through a kind of activity tracker: Fitbit ONE.

A total of 100 participants who will receive total knee arthroplasty will be recruited in this study. Fitbit ONE, the activity tracker, will be used for all of them to monitor the daily steps during the rehabilitation, to be exact, before and at 6 weeks, 3 months, 6 months, 1 year after TKA. Moreover, pain score, self reported questionnaire will also be estimated at those time points.

Eligibility Criteria:
Inclusion Criteria:

* Ready to receive single-side TKA

Exclusion Criteria:

* contraindication of surgery
* self-reported diseases that cause lower limb disability (for example, cerebrovascular disease especially stroke)