cyrilzakka/clinical-trials huggingface dataset:
Impacts on Health Outcomes and Resources Utilization of Hospital-at-home for Elderly Patients With Multiple Myeloma

The study aims to compare the overall survival adjusted to quality of life of 2 groups of patients with multiple myeloma, depending on the type of care: (1) day hospitalization exclusively or (2) day hospitalization combined with hospital-at-home.

As secondary objectives, the study aims to compare the impacts of the two types of care organization on:

* the survival of patients and response to treatments according to criteria of the International Myeloma Working Group,
* psychological status of patients,
* specific toxicity related to treatment used (haematological and infectious toxicity, neurotoxicity, ...),
* health outcomes,
* the caregiver's burden,

This study is combined with a qualitative study about the incentives and the barriers, and in order to set up the patient's typology.

Multiple myeloma, a malignant blood disease with about 5000 new cases diagnosed annually in France, essentially in the elderly population, is associated with alteration of quality of life resulting from pathology and therapies.

Multiples cycles of chemotherapies are administered in a regular manner, as outpatient treatment or day hospitalization.

In this study aiming to explore the impacts on health outcomes and resources utilization of hospital-at-home for elderly patients with multiple myeloma, all patients will be treated by 4 standardized protocols of treatment including bortezomib by subcutaneous administration.

9 centers will participate to the study. The study will not change the usual practices of care of these centers:

* 6 centers organize patient care through day hospitalization combined with hospital-at-home,
* 3 other centers rely exclusively on day hospitalization.

The study will target overall the inclusion of 300 patients for the 9 centers and 70 participants (35 for each arm: 10 patients, 10 caregivers, 15 from healthcare team) for the qualitative study.

The individual follow up of each patient will last 12 months. The patient's vital status will be documented at the 24th month.

Eligibility Criteria:
Inclusion Criteria:

* Patient \> 65 years;
* Resident of the departments in Île-de-France region (75, 92, 93 and 94);
* Symptomatic multiple myeloma (relapsed or no);
* Patient planned to receive one of the following chemotherapy protocols including bortezomib (VELCADE®): VMP (Velcade, Melphalan, Prednisone), VCD (Velcade, Cyclophosphamide, Dexamethasone), VelDex (Velcade, Dexamethasone), VRD (Velcade, Revlimid, Dexamethasone);
* Ineligible for autologous hematopoietic stem-cell transplantation (ASCT);
* Covered by a health insurance;
* Patient who does not oppose to the use of his/her medical data for the purpose of clinical research.
* Adult patients under guardianship will can be enrolled in the study, a consent of tutor is needed completed by patient's consent.

Exclusion Criteria:

* Resident of the departments of 77, 78 and 91 in Île-de-France region;
* Asymptomatic myeloma;
* Life expectancy \< 6 months;
* Patient does not understand French language.
Comparison of Two Different Skin-to-skin Contact Techniques: Sustained Diagonal Flexion vs. Traditional

This is a prospective, controlled randomized study designed to compare the effects of two methods of skin-to-skin positioning of preterm infants: the prone positioning method currently used (according to the World Health Organization's recommendations) and the recent "sustained diagonal flexion" method (SDF) on the daily duration of skin-to-skin contact.

This is a prospective, controlled, randomized, non-blinded trial, recruiting premature infants between 27- 34 weeks of gestational age during the first 4 days of life.

80 parent-infant dyads will be recruited in the Department of Neonatology (GA between 27 and 34 weeks) and randomly divided in two groups. Each dyads will be assigned to one of the two skin-to-skin positions.

The study aims to investigate if the sustained diagonal flexion method (SDF) provides additional benefits for both the child and their parents, such as increase in daily skin-to-skin time and its continuation after discharge.

The investigators will analyze the daily duration of skin-to-skin, the cardiorespiratory stability of the child (number of incidents recorded by standard monitoring), the presence of pain during: installation /skin-to-skin/ after the return to the incubator, the continuation of skin-to-skin, breastfeeding after discharge, the risk of postpartum depression in the mother, parental stress, joint mobility and muscle tension of the child and their parents, and also the comfort and satisfaction with the type of skin-to-skin.

Eligibility Criteria:
Inclusion Criteria:

* Premature infant born between 27 and 34 weeks of gestational age
* Aged between 24 hours and maximum 4 days at the beginning of the study
* Approval from the neonatologist in charge of the patient to participate in the study
* Informed consent of the parents to participate in the study
* At least one of the two parents must have a good knowledge of French.

Exclusion Criteria:

* Infant with severe secondary neurological or medical conditions, e.g., neurological deficits due to vascular hemorrhage (grade III or IV)
* Infant or parent who requires or has required surgery during their neonatal stay
* Triplets
* Parent who suffers from a physical disability or severe psychological illness, a psychosocial situation that does not allow skin-to-skin care
* Infant with an arterial line
Polymorphism of Estrogen Genes in Stroke

The purpose of this study is to explore the association between the genetic polymorphisms of estrogen-related genes, including estrogen synthesis, metabolizing, and receptor genes, and ischemic stroke. Furthermore, independent and joint effects of traditional risk factors and estrogen related genes on risk of stroke in young adults will also be examined in this study.

Cerebrovascular diseases are the third leading cause of death in Taiwan in 2007. It is also the most important reason for disability among elderly adults. Sex hormones are well reported to be associated with cardiovascular disease risk. Several studies showed that estrogens have been shown to have beneficial effects on the cardiovascular system via favorable effects on anti-inflammatory effects. Genetic polymorphisms of estrogen related genes are speculated to influence estrogen level and will count for human susceptible to risk of stroke in young adults. In addition, several studies showed that the decrease in estrogen-induced vascular inflammatory markers including adhesion molecules and chemokines might be the mechanism for vascular protection. Recently, a novel and unique mechanisms for 17β-Estradiol (E2) anti-inflammatory activity which is E2 prevents inflammatory gene transcription induced by inflammatory agents by inhibiting NF-κB intracellular transport was found. Therefore, we proposed a study to explore the association between the genetic polymorphisms of estrogen-related genes, including estrogen synthesis, metabolizing, receptor genes, and NF-κB and ischemic stroke in young adults.

Eligibility Criteria:
Inclusion Criteria:

* incident ischemic stroke patients diagnosed by CT or MRI.

Exclusion Criteria:

* non ischemic stroke patients
Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly

The purpose of this study is to determine the safety and effectiveness of a specific brand of cranial remolding orthosis (a custom made helmet), which is new to the United States market

The purpose of this study is to determine the safety and effectiveness of a specific brand of cranial remolding orthosis (a custom made helmet), which is new to the United States market. Serkel is an Australian company that specializes in the fabrication of 3D printed cranial remolding orthoses (CRO) to treat infants with deformational head shapes. Serkel has made over 600 helmets that have treated children with deformational head shapes in Australia, however it's specific helmet design is not FDA approved to provide treatment in the United States market. Serkel is seeking FDA approval of their brand of CRO by providing CRO's for pre market fitting. The study includes treatment for children who have been screened and diagnosed with a positional deformational head shape. Those who qualify for a FDA approved CRO treatment and were given the option to participate in the study. If they were interested, an inform consent provided and reviewed together. Cargivers then had the option to enroll. In total, 18 participants were enrolled. Fabrication scans were taken of the subjects head, and they returned 2 weeks later for fitting of the 3D printed cranial remolding orthosis, and seen for follow up every 2-4 weeks until treatment was complete (head shape corrected or participant outgrew CRO).

Eligibility Criteria:
Inclusion Criteria:

* Participants between the ages of 4-18 months at evaluation
* Participants with physician prescription of CRO treatment
* Participants with physician diagnosis of deformational plagiocephaly
* Participants who skulls measurements qualify them for standard CRO treatment (CVA measurement is greater than 6mm and Cephalic Index is greater than 92%)

Exclusion Criteria:

* Participants younger than 4 months at evaluation
* Participants older than 18 months at evaluation
* Participants without physician prescription for CRO treatment
* Participants without physician diagnosis of deformational plagiocephaly
* Participants whos skull measurements or asymmetries do not qualify them for standard CRO treatment
Long-term MOno-Antiplatelet Drug Strategy After PerCutanEous CoronAry InterveNtion

The OCEAN (long-term mOn-antiplatelet drug strategy after perCutanEous coronANy intervention) study is the largest prospective multicenter data base to investigate the long-term incidence and prognosis of the use of agents for antiplatelet-induced GI injury symptoms (AI-GIS) or GI hemorrhage among patients undergoing PCI. The OCEAN study will provide evidence of the long-term incidence and prognosis of use of agents for AI-GIS among patients undergoing PCI. It has the potential to provide an optimal long-term mono-antiplatelet strategy.

This is a multicenter prospective observational study that will collect data on \>1000 alive patients who have undergone PCI between 1 and 1.5 years prior at 9 hospitals from October 2018. Adult patients (aged ≥18 years) undergoing PCI and prescribed mono-antiplatelet agents (such as aspirin, dihydroxyaluminum aminoacetate-heavy magnesium carbonate-aspirin, and clopidogrel) are eligible for enrollment. In phase 1, patients will be investigated in a cross-sectional manner for the withdrawal rate of dual antiplatelet agents within 1 year after stent implantation. In phase 2, patients will be followed up at 1, 3, and 6 months for AI-GIS and other outcomes. The primary endpoint is AI-GIS (according to the Gastrointestinal Symptom Rating Scale score) or gastrointestinal hemorrhage. Secondary outcomes will include bleeding, antiplatelet replacement/discontinuation, health economic cost, utilization ratio of gastrointestinal-protective drugs, and MACE.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Currently alive at 1-1.5 years after PCI
3. Considered by the physician to be suitable for long-term treatment with mono-antiplatelet agents and is currently using a mono-antiplatelet drug (aspirin, clopidogrel, or dihydroxyaluminum aminoacetate-heavy magnesium carbonate-aspirin \[ASIDE\])
4. Provided written informed consent for this study.

Exclusion Criteria:

1. Refusal to sign the informed consent form
2. Acute coronary syndromes
3. Cerebral thrombosis within 1 month or cerebral hemorrhage within 1 year
4. Hematopathy or non-GI bleeding tendency
5. Allergy to aspirin
6. Severe uncontrolled hypertension (\>180/110 mmHg)
7. Pregnancy or lactation
8. Drug or alcohol abuse
9. Malignant tumor or \<1-year life expectancy
Posterior Corpectomy in Thoracolumbar Spinal Metastatsis

To analyze the short-term outcomes of posterior corpectomy of patients with thoracolumbar spinal metastasis in spine unit in Assiut University hospital regarding the pain control , neurological status , complication and ambulatory status as well as mortality rate.

The metastasis is the spread of cancer from one part of the body to another. Two-thirds of patients with cancer will develop bone metastases. Breast, prostate and lung cancer are responsible for more than 80% of cases of metastatic bone disease. A spinal metastasis may cause pain, instability and neurological injuries.

* The spine is the most common site of bone metastasis . It is estimated that over the 10% of patients with cancer will develop a symptomatic spinal metastasis . Algra et al. suggest that the initial anatomic location of metastases within vertebrae is in the posterior portion of the body.
* Spinal metastases are the most common tumors of the spine, comprising approximately 90% of masses encountered with spinal imaging. Within the spinal column, metastasis is more commonly found in the thoracic region, followed by the lumbar region, while the cervical region is the least likely place professionals find metastasis .
* Spinal metastases most commonly affect the vertebral bodies of the spinal column, and spinal cord compression is an indication for surgery. Commonly, an open posterior approach is employed to perform a transpedicular, costotransversectomy or lateral extracavitary corpectomy. Because of the short life expectancies in patients with metastatic spinal disease, decreasing the morbidity of surgical treatment and recovery time is critical.
* At present, both surgical and nonsurgical treatments are used for the treatment of spinal tumors, however, treatment outcome is dependent on various factors, such as patient age, overall health of the patient .
* When treating patients with vertebral metastases, surgical strategy is mainly based on life expectancy, primary site of tumor, and staging. This helps determine which patients will benefit from surgery and the type of procedure. Tokuhashi developed a score to determine life expectancy in order to facilitate the treatment modality decision .
* Vertebral corpectomy refers to the removal of one or more vertebral bodies from the spine, as well as the intervertebral discs above and below the surgical level.

Corpectomies may be accomplished through a multitude of approaches. Posterior approaches have been associated with less intraop- erative blood loss, complications, shorter operative time, and better pul- monary function post-operation compared to anterior approaches .

Eligibility Criteria:
Inclusion Criteria:

Patients \> 18 years old Patient diagnosed as cancer Intractable pain Progressive neurologic comprise Radioresistant tumors

* Failure of radiotherapy
* Failure of chemotherapy
* Fit for surgery

Exclusion Criteria:

Patient younger 18 years old spinal 1ry tumor
Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study B

The purpose of this study is to test the feasibility of trials that change the dialysis ultrafiltration rate (UFR) by limiting the maximum rate and to estimate the extent to which limiting the ultrafiltration rate reduces the risk of abnormal heart rhythms in people with kidney failure who are being treated with chronic hemodialysis.

Within four weeks of consent, subjects will have an Implantable Loop Recorder (ILR) (Medtronic LINQ) device implanted. Subjects will be given a transmitter/charger and a Patient Care Assistant which they will be required to keep for the duration of their participation in the study. ILR tracings will be uploaded automatically and reviewed by the study team for the occurrence of clinically significant arrhythmia.

Following ILR implantation, subjects will alternate between weekly periods in which the ultrafiltration rate can be unlimited or in which the ultrafiltration rate is limited to ≤10mL/kg/hour.

Eligibility Criteria:
Inclusion Criteria:

* Maintenance hemodialysis therapy for end-stage renal disease
* Age 18-85 years (subjects between 18-40 years old will be required to have at least one of the following: history of congestive failure, diabetes, coronary or peripheral vascular disease, or arrhythmia)
* \>30 days since dialysis initiation
* Ability to provide informed consent
* Interdialytic weight gain necessitating an UF rate of ≥13mL/kg/hour of dialysis to achieve the target post-dialysis weight in at least half of the dialysis sessions (≥6 sessions) in the month prior to enrollment

Exclusion Criteria:

* Expected survival \<6 months-to allow trial completion
* Renal transplant, transfer to home or peritoneal dialysis, or to non-study hemodialysis facility anticipated within 6 months
* Prisoners or cognitive disability preventing informed consent
* Pregnancy. A pregnancy test will be required for women of child bearing potential prior to enrollment. A pregnancy test will not be required for women past the age of child-bearing potential \>55 years old, women with a history of surgical sterilization, or for women \<55 years of age who have not had a menses within the past 12 months
* Skin condition, immune dysfunction, history of multiple infections or other condition which increases risk of local infection with ILR placement
* Bleeding disorder or anti-coagulation that cannot be reversed for ILR placement
* Existing pacemaker, implantable monitor or defibrillator which precludes device placement
* Chronic, persistent AF (defined as the presence of persistent AF on all available EKGs at time of recent screening)
Single Cohort 4-period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine

The purpose of this study is to evaluate the effect of steady-state ranolazine on the steady state PK of metformin in subjects with type 2 diabetes mellitus (T2DM).

The primary objective of this study is as follows:

• To evaluate the effect of steady-state ranolazine on the steady state PK of metformin in subjects with T2DM.

The secondary objectives of this study are as follows:

* To examine the safety and tolerability of metformin when co administered with ranolazine at steady-state in subjects with T2DM.
* To determine the steady-state PK of ranolazine in subjects with T2DM receiving metformin.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, 30 to 65 years old, inclusive
* Documented history of T2DM
* HbA1c = 6.5%-10%, inclusive
* Fasting serum glucose ≤ 270 mg/dL at Screening
* Fasting C-peptide ≥ 1 ng/mL at Screening
* Stable metformin monotherapy (metformin 1000 to 2000 mg total daily dose for at least 4 weeks prior to Screening)
* Body mass index (BMI) = 25 to 40 kg/m2, inclusive, at Screening
* Creatinine Clearance \> 80 mL/min at Screening
* Females of child-bearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1 and must agree to use highly effective contraception methods from Screening throughout the duration of the Treatment Period and for 14 days following the last dose of study drug

Exclusion Criteria:

* Type 1 Diabetes Mellitus (T1DM)
* Use of insulin therapy \< 3 months prior to Screening
* History of ketoacidosis, ketosis-prone diabetes, or lactic acidosis
* Clinically significant complications of diabetes
* History of hypoglycemia
* Any non-insulin antidiabetic therapy (other than metformin) \< 2 months prior to Screening
* Any clinically significant cardiovascular event \< 2 months prior to Screening
* Clinically significant, inadequately controlled, or unstable hypertension
* Hospitalization \< 2 months prior to Screening or major surgery \< 3 months prior to Screening
* History of gastrointestinal disease or surgery that could impact drug absorption
* History of substance of alcohol or substance abuse
* Positive urine drug screen for drugs of abuse
* Positive alcohol breath test
* Any other clinically significant existing medical or psychiatric condition or one requiring further evaluation
* Treatment with selected medications
* Hemoglobin \< 12 g/dL for males; or \< 11 g/dL for females at Screening
* Active thyroid disease (hypo- or hyperthyroidism)
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5x upper limits of normal
* QTc interval \> 500 msec at Screening
* Females who are pregnant or are breastfeeding
An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.

To evaluate the potential pharmacokinetic interaction between nevirapine and clarithromycin, and to determine the effects of nevirapine on cytochrome P450 3A4 (CYP3A4) activity in vivo.

The study is conducted in two separate groups. Patients in Group I receive clarithromycin orally for 32 days and nevirapine orally for 28 days.

Patients in Group II receive erythromycin intravenously on days 0, 14, 28, and 43 and nevirapine orally for 28 days.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

Antiretroviral drugs (i.e., zidovudine, zalcitabine, stavudine, lamivudine, didanosine, indinavir, saquinavir) provided that there has been no change in dosing of the medication \> 25% within 4 weeks of study entry.

Patients must have:

* HIV positive status.
* CD4 count \>= 100 cells/mm3.

Prior Medication:

Allowed:

Patients may be on clarithromycin at study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions are excluded:

Malabsorption, severe chronic diarrhea, or inability to maintain adequate oral intake.

Concurrent Medication:

Excluded:

Macrolide antibiotics (erythromycin, azithromycin, dirithromycin), azole fungals (ketoconazole, fluconazole, itraconazole), rifampin, rifabutin, phenytoin, terfenadine, astemizole, cisapride, triazolam, midazolam, other non-nucleoside reverse transcriptase inhibitors, antibiotics containing clavulanic acid, and Augmentin.

Patients with the following prior conditions are excluded:

* History of drug allergy or known drug hypersensitivity.
* History of clinically important disease including hepatic, renal, cardiovascular, or gastrointestinal disease.

Prior Medication:

Excluded:

* Investigational drugs or antineoplastic agents within 12 weeks of study entry.
* Participation in a clinical trial that used ERMBY within one year of study entry.
* Systemic treatment with drugs known to be potent hepatic enzyme inducers or inhibitors (e.g., oral macrolide antibiotics, azole antifungals, cimetidine, rifampin, rifabutin, and carbamazepine) within 28 days of study entry.
* Use of protease inhibitors; ritonavir, nelfinavir, indinavir, or non-nucleoside reverse transcriptase inhibitor compounds e.g., delavirdine) within 4 weeks of study entry.

Prior Treatment:

Excluded:

Radiotherapy within 12 weeks of study entry.

Risk Behavior:

Excluded:

Current history (within the last year) of IVDA, ETOH, or substance abuse.