cyrilzakka/clinical-trials huggingface dataset:
First in Human Study to Determine the Safety, Tolerability and Preliminary Efficacy of an Anti-CXCR4 Antibody in Subjects With Acute Myelogenous Leukemia and Selected B-cell Cancers

The purpose of this study is to assess the safety and tolerability of BMS-936564 (MDX-1338) in relapsed Acute myelogenous leukemia (AML) and other selected B-cell cancers and to determine the maximum tolerated dose (MTD) of the drug alone in relapsed/refractory AML


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

A. Common to All Indications:

* Life expectancy at least 12 weeks
* ECOG Performance Status of 0-2

B. For Acute myelogenous leukemia (AML) Subjects:

* First Relapse and primary induction failure in AML (M3 excluded)
* Secondary AML subjects from myelodysplastic syndrome (MDS) or prior chemotherapy are eligible. MDS-only subjects are not eligible

C. For Follicular Lymphoma (FL), Diffuse Large B-Cell Lymphoma (DLBCL) Subjects:

* Must be at least 4 weeks (for FL) or 2 weeks (for DLBCL) since prior cytotoxic, biologic, monoclonal antibody, or investigational therapy
* Ability to undergo tumor biopsy pre-treatment and at end of monotherapy period (though not mandatory for all subjects)
* Subjects must have a histologically confirmed diagnosis of relapsed or refractory disease

D. For Chronic lymphocytic leukemia (CLL) Subjects:

* Subjects must have a histologically confirmed diagnosis of relapsed or refractory disease
* Must be at least 4 weeks since prior cytotoxic, biologic, monoclonal antibody, or investigational therapy, including corticosteroids

Exclusion Criteria:

A. Common to All indications:

* Prior anti-CXCR4 therapy including BMS-936564 (MDX-1338)
* Less than 3 months from prior hematopoietic stem cell transplant
* Presence of active graft versus host disease

B. For AML Subjects:

* Acute promyelocytic leukemia (M3)
* Left ventricular ejection fraction \< institutional limits of normal

C. For FL, DLBCL Subjects:

* (For DLBCL): Inadequate renal function defined as creatinine clearance (by Cockcroft-Gault formula) \< 60 mL/min
* Major surgery, not related to debulking procedures, within 21 days of first dose
* Myocardial infarction within 6 months prior to screening or Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
* Myelodysplastic syndrome (MDS)

D. For CLL Subjects:

* No progression to more aggressive B-cell cancers, such as Richter's syndrome
* Major surgery within 21 days of Cycle 1, Day 1. Patients undergoing debulking procedures and minor surgery are allowed after a recovery period, in the judgment of the Investigator
* Myocardial infarction within 6 months prior to screening Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
Exercise in Pregnancy and Risk of Postpartum Depression

The prevalence of postpartum depression (PPD) varies between 11.9% and 19.2% during the perinatal period. PPD refers to minor and major depression incidents that occur during pregnancy or shortly after (up until 12 months after birth). The symptoms of PPD embrace feeling sad or having a depressed mood, being uninterested in the new-born, unreasonable crying and fear of injuring or harming the baby. Consequently, PPD can negatively impact the mother's well-being and the baby's development. The impact on a child can be short for cognitive and motor development . Although medication is a feasible alternative, many women have constraints due to continuing breastfeeding. Therefore, exercise can be an alternative that could help to deal with PPD. Exercise can be used as a preventive or treatment of mild depression at an early stage and as an addition to a treatment plan for major depressive disorder. Exercising during pregnancy and postpartum improves psychological health and also benefits physical fitness, weight gain control and the prevention or reduction of musculoskeletal discomfort and pain. Therefore, the American College of Obstetrics and Gynaecologists has recommended that women during pregnancy and postpartum engage in moderate-intensity physical activity almost every day for 30 min a day

The prevalence of postpartum depression (PPD) varies between 11.9% and 19.2% during the perinatal period. PPD refers to minor and major depression incidents that occur during pregnancy or shortly after (up until 12 months after birth). The symptoms of PPD embrace feeling sad or having a depressed mood, being uninterested in the new-born, unreasonable crying and fear of injuring or harming the baby. Consequently, PPD can negatively impact the mother's well-being and the baby's development. The impact on a child can be short for cognitive and motor development . Although medication is a feasible alternative, many women have constraints due to continuing breastfeeding. Therefore, exercise can be an alternative that could help to deal with PPD. Exercise can be used as a preventive or treatment of mild depression at an early stage and as an addition to a treatment plan for major depressive disorder. Exercising during pregnancy and postpartum improves psychological health and also benefits physical fitness, weight gain control and the prevention or reduction of musculoskeletal discomfort and pain. Therefore, the American College of Obstetrics and Gynaecologists has recommended that women during pregnancy and postpartum engage in moderate-intensity physical activity almost every day for 30 min a day

Eligibility Criteria:
Inclusion Criteria:

* singleton gestation
* low risk pregnancy
* age between 20 and 40

Exclusion Criteria:

* high risk pregnancy
* multiple gestation
* prior post partum depression
* any psychiatric disase
* controindication for exercise
* lung or heart disease
* prior preterm birth
* IVF pregnancy
* women who already perform agonistic sport activity
Analisys of Neuromuscular Response, Postural Balance and Quality of Life of Diabetics Type 2 After Sensory-motor Training: Blind Random Controled Clinical Trial

Background: The individual's ability to sustain itself in the upright position, effectively adjusting the body's movements and reacting to external stimuli, postural control strategies represent essential activities of daily living. Diabetes mellitus type 2 (DM-2) is considered a more problem of Public Health as having complications deficit in functional performance of the lower limbs and falls, which can interfere with the maintenance of balance, and is a strong predictor of functional limitations self referred. Aim: To assess quality of life and the answers neuromuscular balance and baropodometric after sensory-motor training in patients with type 2 diabetes. Method: To be recruited 50 volunteers aged between 45 to 64 years with DM-2, of both sexes, divided into two groups: 1) Guidelines and 2) Guidelines + sensory-motor training. Biomechanical data will be collected (balance, baropodometry, electromyography strength and joint position sense), as well as questionnaires ADDQoL and BESTest. The intervention will be twice a week for 45 minutes for 12 weeks, divided into three phases: heating, sensory-motor training and cool-down, with monitoring of blood pressure and blood glucose. There will be a follow up after 3 months of intervention. Statistical analysis will be used normality test to verify the data distribution and consistent statistical test for the appropriate comparisons within and between groups, and adopted a significance level of 5%. Expected Results: Considering previous studies that demonstrate improvement in postural balance static and dynamic responses under the forward training protocol sensorimotor disease Diabetes mellitus type 2, is expected to improve neuromuscular, balance, distribution plant, the joint position sense and the quality of life of voluntary DM-2.

Keywords: physical therapy modalities, exercise therapy, postural balance, Diabetes Mellitus, quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes mellitus type 2 with controlled blood glucose
* Absence of skin lesions or fractures of the lower limbs in the last 6 months -Plantar malformations
* Severe postural abnormalities and limb length difference.

Exclusion Criteria:

* Use of medications that can have negative effects on the function of cognition, attention and psychomotor (ie, opioids, antiepileptics, anxiolytics, antipsychotics, hypnotics and sedatives)
* Diagnosis of cardiovascular, neurological, rheumatological and musculoskeletal disorders that may interfere with activities of daily living
* Presence of vestibular disorders
Effectiveness of Intravenous Immunoglobulins (IVIG) in Toxic Shock Syndromes in Children

IGHN2 is an international, multicenter, double blind, randomized controlled trial aimed at assessing the efficacy on organ dysfunctions of Intravenous Immunoglobulins (IVIG) treatment in the acute phase of streptococcal or staphylococcal toxic shock syndrome in children.


Eligibility Criteria:
Inclusion Criteria:

* Child/adolescent: 1 month \< Age \< 17 year-old,
* admitted to PICU with a strong suspicion of staphylococcal or streptococcal infection; at least one following criterion, with at least one following criteria:

  1. Toxic Shock Syndrom as defined by Centre for Disease Control criteria
  2. or group A Streptococcus necrotizing fasciitis (positive streptest)
  3. or varicella with infected lesions and rash or positive streptest
  4. or erythrodermic rash in menstrual period
  5. or pleuropneumonia with erythrodermic rash or positive streptest in pleural fluid
  6. or erythrodermic rash and biological fluid positive to streptococcus A or staphylococcus (articular, pericardial, bronchopulmonary, pharynx)
* With shock resistant to fluid resuscitation, defined as existence, despite 40 ml/kg of fluid bolus within 1 hour, of:

  1. hypotension (\< 5th percentile)
  2. or systolic blood pressure \< 2 SD regarding age
  3. or need for vasoactive drugs in order to maintain blood pressure at a normal level (dopamine \> 5µg/kg/min or dobutamine, adrenaline, noradrenaline, milrinone whatever the dose)
  4. or 2 signs of hypo perfusion among:

     1. metabolic acidosis with base deficit \> 5
     2. lactate x 2 normal laboratory value
     3. diuresis \< 0,5 ml/kg/h
     4. capillary refill time \> 5 sec
     5. Skin/central temperature difference \> 3°C
* With informed consent signed by at least one parent before any procedures or treatments related to the study.

Exclusion Criteria:

* First signs of shock appeared more than 24h ago
* Known hypersensitivity to one of the components (study treatment or placebo , see below)
* Hypersensitivity to homologous immunoglobulins, specifically in very rare cases of Ig A deficit, when the patient has anti-IgA antibodies
* Known hyperprolinemia
* Immunodeficiency (acquired or not),
* Immunosuppressive drugs
* No health cover
MOTIVATE AF Motivational Support for Patients With Atrial Fibrillation to Promote Weight Loss

This study is designed to look at the impact that support and motivation has on patients with Atrial Fibrillation's ability to lose weight and maintain this. We believe that weight loss has a positive impact on the reduction of symptoms of atrial fibrillation and can decrease the likelihood of the arrhythmia returning following cardio version.

This study is designed for patients who have a diagnosis of Atrial Fibrillation and have a Body Mass Index greater than 27.

In the study, we plan to provide support and motivation to patients with atrial fibrillation to encourage weight loss. There are several weight loss strategies available to follow. Information will be provided about each strategy to encourage informed choices. If the initial strategy chosen is not working, this can be change to a more suitable one as required. Follow up will be by telephone at 2 and 4 weeks then every month thereafter where you will be asked your weight and to clarify the weight loss strategy you are following. You will be seen at 6 and 12 months where you will have an ECG, BP check and your weight measured. A final telephone assessment will take place at 24 months.

We hope that the research will in the future help patients with Atrial Fibrillation manage and maintain their weight loss to improve their symptoms and prevent recurrence of the arrhythmia. The results of this study could potentially change practice in our centre by providing more structured weight loss clinics for patients with Atrial Fibrillation


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* BMI\>27
* Symptomatic AF
* Committed to monthly follow up phone calls and bi annual visits.

Exclusion Criteria:

* Any co morbidity that would reduce life expectancy to within the year.
* Unable to commit to follow up.
* Patients recruited to weight loss studies that are on going
Perioperative Assessment of Physical Capacity in Elderly Patients Undergoing Laparoscopic Colorectal Surgery

Evaluation of preoperative physical capacity and its evolution in the postoperative period in older patients after undergoing laparoscopic surgery for colorectal cancer, with the test:

- Short Physical Performance Battery (SPPB)

After the inclusion of the first 10 patients, a preliminary feasibility study will be carried out and thus we have coverage of this pilot study.


Eligibility Criteria:
Inclusion Criteria:

* Patients age ≥65 years.
* ASA I-III
* Patients with absence of cognitive deficit.
* Informed consent signed prior to surgery.

Exclusion Criteria:

* Refusal of the patient to participate in the study.
* Patients with disabilities to give their consent.
* ASA IV-V.
* Pregnancy or lactation.
* Health status that prevent physical exercise, such as unstable heart disease, severe systematic disease, or serious orthopedic conditions
Realizing Opportunities for Self Empowerment

The purpose of this study is to determine whether priority-based patient navigation will improve patient satisfaction, quality of life (QOL), and depression when compared to screening-and-referral for socioeconomically disadvantaged women's health patients with depression. The investigators goal is to establish patient-driven, effective, generalizable, and disseminable interventions to reduce depression-related disparities and improve outcomes.

* In this comparative effectiveness study, 200 participants who are patients at the University of Rochester Women's Health Practice or Highland Woman's Health and report significant depressive symptoms will be randomized to either PSP (Personal Support for Progress) or ESR (Enhanced Screening and Referral). Participants assigned to PSP will work with a patient navigator to prioritize their concerns, develop a personalized care plan, and implement their plan. Participants assigned to ESR will receive a personalized report of community resources that may be helpful for their identified needs.
* The investigators will use a simple 1:1 randomized design with treatment assignment being conducted using a random number generator. All analyses will follow an intent-to-treat protocol, such that all participants randomized will be followed for data collection and analyzed according to her randomized condition
* Each participant will be assessed 4 times for outcome changes: at baseline, post treatment (4 months), and two follow up ( at 7 and 10 months).
* Assessments are self report on iPads and they are linked directly to a Red Cap database.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with depression (PHQ9 score 10 or higher)
* Patient of University of Rochester Women's Health Practice or Highland Women's Health
* Monroe County resident
* English speaking

Exclusion Criteria:

* Currently receiving case management services
* In need of acute psychiatric services
* Unable to commit to the duration of the project
Reliability of Polish-Version Overactive Bladder Syndrom Scores (OABSS)

The aim of this study was to develop and assess the effectiveness of a Polish version of OABSS and to correlate the OABSS with urodynamic study results and UDI-6, IIQ-7 questionnaires

The translation into Polish followed standardized procedures. Women aged between 18-75 years were included into the study. All patients were recruited from women attending the Outpatient Clinic of the 2nd Gynecology Department of the Medical University in Lublin. SUI was observed in 290 cases; OAB in 283 patients and 249 had MUI (confirmed by medical history, and urodynamic investigation). All patients completed the Polish version of the OABSS on two separate visits: Week 0 and Week 2 and additionally UDI-6, IIQ-7 during visit- Week 2.

Eligibility Criteria:
Inclusion Criteria:

* confirmed Urinary Incontinence in Urodynamic study (SUI, OAB, MUI)
* female aged 18-75 years old

Exclusion Criteria:

* malignant disorders
* uncontrolled diabetes
* inability to understand informed consent
Effects of Bobath Technique Versus Task Oriented Training on Gross Motor Function in Cerebral Palsy Children

Cerebral palsy is the most familiar motor disorder of childhood. Consistent with the results of recent scientific researches BOBATH approach in physical restoration of youngsters with cerebral palsy promotes formation of motor skills. Improvement in mobility has been primary goal in treatment of CP. There are only a few studies available within the efficacy of "task-oriented training" to improve gross motor function in CP child. Hence, this comparative study is undertaken to gauge the effect of task-oriented training verses neurodevelopmental training on gross motor function in cerebral palsy child. Objective of this study is to find out the effects of BOBATH technique and Task Training on gross motor function in cerebral palsy children. A Convenient sample of Cerebral Palsy children fulfilling inclusion and exclusion criteria, from physiotherapy OPD of Allied \& DHQ hospitals of Faisalabad will be considered. Informed consent will be taken from all patient's caregivers. Patients will be divided into two groups through chit draw randomization. Age of children will be 3 years to 10 years without discrimination of gender. Group A will receive BOBATH training and Group B will receive task training. Data will be collected through Gross Motor Function Measure (GMFM-88). Data analyses using SPSS version 25 as a statistical tool.


Eligibility Criteria:
Inclusion Criteria:

Male and female patient Age 3- 10 years. Diagnosed with CP by a specialist. Children with CP GMFCS level I-II. Types of Cerebral palsy (spastic diplegic, quadriplegic, hemiplegic,) without severe abnormalities Cognitive ability should be sufficient that he/she follow simple verbal commands and instructions during training

Exclusion Criteria:

Patient with fixed contracture Patient receiving treatment that affects motor function such as botulinum injection and orthopedic surgery

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Characterization of the Changes in the Signalling Pathways During Spinal Cord Injury-induced Skeletal Muscle Atrophy

Atrogin-1 and muscle RING finger-1 are skeletal muscle specific genes, with ubiquitin ligase activities, that are upregulated during muscle atrophy in mice. The Akt/GSK3 and Akt/mTOR pathways are involved in muscle hypertrophy in mice. Recent studies by the investigators team and others have demonstrated the implication of these signalling pathways in the control of muscle mass in humans. However no study has yet investigated the involvement of these systems in the early stages of spinal cord injury induced human skeletal muscle atrophy.

The investigators propose to investigate the level of expression of the different components of the ubiquitin-proteasome system together with the level of expression and activity of the Akt/mTOR and Akt/GSK3 signalling pathways after SCI in humans during the first months following the injury.

A second aim of this project is to assess if a novel apparatus of electrical stimulation which generate movements by closed-loop electrical muscle stimulation may improve strength and muscle mass in these patients.

The patients will be recruited jointly at the Clinique Romande de Réadaptation (CRR) in Sion and the Swiss paraplegic centre in Nottwil. They will be randomly divided into two groups, a first group of patients will undergo a conventional treatment of rehabilitation while a second set of patients will be treated using a brand new system of electro-stimulation called MotionMaker TM. Biopsies will be obtained in the first weeks after admission; two other biopsies will be taken respectively 3 and 6 months post-lesion.

Our results will provide an increased understanding of the molecular mechanisms contributing to skeletal muscle atrophy during the early stages following SCI and a characterization of the impact of endurance training in the no more voluntary innervated muscle. Moreover this study will also investigate the potential improvement in the rehabilitation process by using a new system of electro-stimulation.

Measures:

For each group, the muscle biopsies will be divided into 3 samples which will be used for a) real-time PCR to quantify the gene expression of the different components of the ubiquitin-proteasome system (Atrogin-1, MuRF1, Nedd4, UBB and Psma) b) Western blotting, using anti-phospho-site specific antibodies to quantify the activities of the Akt/GSK3 and Akt/mTOR pathways and of their downstream regulators of protein synthesis, eIF2B, p70S6K and PHAS-1/4E-BP1and c) fiber type analysis to quantify the variation in MHC expression.

Eligibility Criteria:
Inclusion Criteria:

* acute, motor complete SCI
* lesion level C5-T12

Exclusion Criteria:

* diabetes type I
* pregnancy
* oral anti-coagulation
* osteosyntheses of the femur
* hepatitis B,C or D
* HIV
Comparison of Basal (Fasting) Glycemic Control in Type 1 Diabetic Patients With CSII Achieved by the Circadian Slide Ruler Scale or Flat Basal Rate

This is a pilot trial to establish study procedures that allow comparison of various starting basal rate profiles used in Continuous Subcutaneous Insulin Infusion (CSII). Glycemic control achieved by circadian 'slide ruler scale' basal rate versus that achieved by one constant basal rate (flat profile) will be compared during a composite fasting day as well as therapeutic success after 2 weeks of normal activity.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>= 18 years of age
* Type 1 diabetes
* Diabetic for \>2 years, and treated with CSII for \>= 3 months
* HbA1c \<=8.5%

Exclusion Criteria:

* Excessive fibrosis or lipo-hypertrophy at injection or infusion sites
* Unstable chronic disease other than type 1 diabetes
* Severe hypoglycemic event within last week prior to study start
* Severe diabetic ketoacidosis within last month prior to study start