cyrilzakka/clinical-trials huggingface dataset:
Parkdale Infant Nutrition Security Targeted Evaluation Project: Focus Groups & Interviews

In Toronto Ontario, the Parkdale Community Health Centre operates a community outreach program entitled Parkdale Parents' Primary Prevention Project (5P's). The 5P's provides weekly pre- and post-natal support and education programs for clients. This includes an infant feeding program for mothers with infants 0-6 months (Feeding Tiny Souls). The 5P's has a diverse client-base; the program is aimed at women who are in challenging life circumstances, therefore, clients may include low-income or single mothers and newcomers to Canada.

The overall goal of this research is to optimize the existing 5P's program. Program acceptability is an essential component of the process evaluation to understand the experiences of mothers and the perceived supports and barriers of the program. Specifically, the aim of this project is twofold: 1) to investigate the perceptions and experiences of accessibility of a postnatal community program and 2) to explore the perceptions of, and attitudes toward, a community infant feeding program offering lactation consultant and breast pump resources. This study will use a qualitative approach by way of semi-structured focus groups and interviews. The study population will consist of women who enrolled in 5P's prenatally and have delivered their infant. This will include women who did and did not continue to participate in the postnatal program and/or Feeding Tiny Souls after delivery. The investigators will specifically seek women who participated in the prenatal program, but did not take part in the postnatal program and/or Feeding Tiny Souls to understand why participants did not access these resources and gather information on their views of these postnatal program components. The hypothesis is that the postnatal community program is a source of support for clients, but that it needs to be expanded to include more clients and the infant feeding program is an important support for helping clients to provide breast milk to their infant.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in Parkdale Parents' Primary Prevention Project (5P's) prenatally
* Delivered their infant between June 1, 2016 and August 16, 2017

Exclusion Criteria:

* Unavailable to participate in a focus group or interview
* Only attended Parkdale Parents' Primary Prevention Project (5P's) postnatally
The Effects of Scapulohumeral Rehabilitation on Scapula Kinematics and Upper Extremity Functionality in Individuals with Parkinson's Disease

With this study, individuals diagnosed with PD in Burdur province in Turkey will be provided with a physiotherapy and rehabilitation program for the upper extremity, and it is thought that the treatment received by both groups will have a positive effect on the functionality of the individuals. According to the results of our study, it will be determined whether the scapula kinematics and upper extremity functionality of individuals diagnosed with PD are different from healthy individuals of the same age and gender. After the intervention programs applied to the individuals, it is thought that it will contribute to the physiotherapy and rehabilitation programs of individuals with PD by determining whether the scapulohumeral rehabilitation program is superior to the upper extremity neurorehabilitation program.


Eligibility Criteria:
Inclusion Criteria:

* For the intervention group:

  * Having been diagnosed with Parkinson's Disease
  * Being between 1-3 according to the Hoehn \& Yahr staging
* For the control group:

  * Being of the same age and gender as the individuals diagnosed with Parkinson's disease included in the study

Exclusion Criteria:

* For the intervention group:

  * Refusing to participate in the study
  * Having a full-thickness rotator cuff muscle rupture
  * Having a history of humerus, clavicle, scapula or shoulder surgery
  * Having a history of humerus, clavicle, scapula or shoulder fracture
  * Having a history of any other disease that may affect the ability to stand independently
* For the control group:

  * Refusing to participate in the study
  * Having a full-thickness rupture of the rotator cuff muscles
  * Having a history of humerus, clavicle, scapula or shoulder surgery
  * Having a history of humerus, clavicle, scapula or shoulder fracture

Study Exclusion Criteria for Volunteers:

* Failure to complete the tests included in the study
* Failure to comply with the study schedule, failure to complete sessions
* Incomplete data
* Failure to attend 3 consecutive sessions
* Voluntary withdrawal
Treatment of Adult-Onset Immunodeficiency With Bortezomib

This is pilot study aimed to investigate the application of proteosome inhibitor, Bortezomib in treatment of patients with neutralizing autoantibody to IFN-γ. The investigators hypothesis is that bortezomib will reduce the antibody level and restore interferon-gamma function, resulting in clinical improvement and should be well-tolerated and safe for use in patients with autoantibody to IFN-γ.

The patients with autoantibody to IFN-γ and past or current history of proven opportunistic infection will receive 2 treatment cycles of bortezomib subcutaneously (4 injections of 1.3 mg Bortezomib /m2 body surface per cycle), followed by low dose oral cyclophosphamide for 4 month after completion treatment with bortezomib.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 - 60 years
* Positive anti-interferon-gamma autoantibody
* Anti-HIV negative
* Past or current infection with opportunistic infection (OI) such as nontuberculous mycobacteria, proven by culture
* Ability to give written consent, informed written consent
* Negative pregnancy test in premenopausal woman
* Receving antimicrobial for treatment of OI for at least one month.

Exclusion Criteria:

* Pregnancy or lactation
* Absolute neutrophil count \<1.5 × 109/ L or platelet count \<100× 109/ L or hemoglobin level \< 8 g/dL
* Past history of myocardial infarction or heart failure within 6 months before enrollment or prolonged QT interval \> 450 msec at screening
* Renal insufficiency (GFR \< 30 ml/min)
* Abnormal liver function test (AST\> 3 times of UNL)
* Known cancer or receiving other immunosuppressive agent
* Known intolerability to Bortezomib
Safety of Purified Meningococcal Vaccine With Serogroups ACWY, in 3,000 Filipino Subjects Aged > 2 Years

GlaxoSmithKline Philippines has submitted a registration file for its Purified Meningococcal Polysaccharide of Serogroup ACWY Vaccine (Mencevax ACWY). This study is being conducted to collect clinical data in the local target population in order to assess the occurrence of rare adverse events after vaccination as per the requirement of Philippines Bureau of Food and Drugs Directive.

All subjects will receive a single dose of GSK Biologicals' Mencevax ACWY vaccine according to the prescribing information. Subjects will be stratified into the following age groups:

2 to 5 years 6 to 17 years \> 18 years The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they and/or their parent/guardian can and will comply with the requirements of the protocol.
* A Filipino male or female \> 2 years of age at the time of the first vaccination.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Written informed consent obtained from the subject and/or from the parent/ guardian of the subject.

Exclusion criteria:

* Subjects suffering from acute severe febrile illness.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Pregnant or lactating female.
* Female planning to become pregnant.
* History of chronic alcohol consumption and/or intravenous drug abuse.
* Any contraindications as stated on the Prescribing Information.
Social Influences on Adolescents' Snack Purchases

The purpose of this study is to assess the effects of peer influences on snack purchases in adolescents. During the session teens will be given a certain amount of money to use to purchase foods and beverages in a hypothetical convenience store setting.

The investigators hypothesize that overweight youth will be less responsive to own-price elasticity for high calorie foods and less likely to show cross price elasticity for low calorie foods when the price of the high calorie for nutrient foods increases. The investigators also predict that overweight youth will show more cross price elasticity for low calorie foods when in the presence of peers; whereas lean youth's food purchases and price sensitivity will not be affected by the presence of peers.


Eligibility Criteria:
Inclusion Criteria:

* Boys and girls ages 12-14
* Youth must have at least a moderate liking of study foods used
* Youth must be at or above the 15th BMI percentile

Exclusion Criteria:

* Youth should have no dietary restrictions
* Youth should have no food allergies
* Youth should have no medical conditions that alter the body's ability to absorb nutrients or that can otherwise influence the participants' response to food
Clinical Trial of Intravitreal Microplasmin in Infants and Children Scheduled for Vitrectomy

To evaluate the safety and preliminary efficacy of intravitreal microplasmin as an adjunct to conventional vitrectomy for the treatment of pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female infants or children 16 years of age or younger
2. Patient must be a suitable candidate for conventional 2-port or 3-port pars plana vitrectomy
3. Patient with attached vitreous somewhere in posterior pole
4. Patient's parent or guardian must be willing and able to comply with follow-up requirements
5. Patient's parent(s) must sign informed parental permission form and in the case of school-age children the patient must sign assent form

Exclusion Criteria:

1. Patient diagnosed with Stage 1, 2, 3 or 5 retinopathy of prematurity (ROP) at the time of surgery
2. Unclear media, which precludes assessment of the posterior pole such as a cataract or vitreal opacity
3. Active parental/guardian drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with parent's or guardian's adherence to study requirements
4. Medical problems that make consistent follow-up over the treatment period uncertain.
5. Patient must not have participated in an investigational drug or device study in the prior 30 days
6. Female Patients of childbearing potential must not be pregnant or lactating.
Influence of Education on Acceptance of Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Among Women

The goal of this research study is to measure what percentage of women who suspect they have symptoms of ADHD will go on to be diagnosed with ADHD using accepted practice standards. The study will also evaluate the influence education on the genetics of ADHD has on a woman in her deciding to receive behavioral health treatment for ADHD.

Attention Deficit Hyperactivity Disorder (ADHD) affects approximately 10-12% of school-aged children in the United States, making it one of the most common psychiatric disorders in children. It is characterized as inattention and hyperactivity-impulsivity, which has persisted for at least 6 months to a degree that is maladaptive and inconsistent with developmental level (DSM-IV-TR). ADHD is a non-fluctuating illness unlike many other psychiatric co-morbid conditions.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be females, 18 through 59 years of age
* Subjects must think they have ADHD or have been previously diagnosed with ADHD but may not have received any treatment for ADHD
* Subjects must be able to participate in the informed consent process and give their written consent to participate in the study

Exclusion Criteria:

* Subjects who have been treated (at any time) for ADHD will be excluded from the study
* Potential subjects consuming greater than 21 units of alcohol (1 unit=12.0 ounces beer, 1.5 ounces hard liquor or 5.0 ounces wine) a week will be excluded from the study
* Potential subjects currently experiencing suicidal ideation or who have been hospitalized within the past six months for suicidal ideation will be excluded from the study
An Open-label Trial of Clevidipine for Controlled Hypotension During Spinal Fusion

The current study would prospectively evaluate the dosing requirements, efficacy and safety of clevidipine for controlled hypotension during spinal surgery in the pediatric population. As the investigators currently have projects underway which include those patients having scoliosis surgery for idiopathic scoliosis, this trial would include only those undergoing scoliosis surgery for neuromuscular disease.

This would basically be an observational study without a significant change in our current practice. There would be no change in the standard and usual anesthetic care including premedication, anesthetic induction, intraoperative anesthetic management, and intraoperative monitoring. Our usual anesthetic routine includes:

1. Intravenous or oral premedication with midazolam
2. Inhalational or intravenous induction based on the preference of the patient
3. Facilitation of endotracheal intubation with a dose of rocuronium with placement of intraoperative monitors including an arterial cannula
4. Maintenance anesthesia to include desflurane titrated to maintain the bispectral index at 40-60, fentanyl 2-4 µg/kg followed by a remifentanil infusion to maintain the mean arterial pressure at 55-65 mmHg.
5. Tranexamic acid to limit intraoperative bleeding
6. As needed, agent to control blood pressure to maintain the MAP at 55-65 mmHg if remifentanil in doses up to 0.3 µg/kg/min are ineffective.

As needed, clevidipine will be started at 1 µg/kg/min and titrated up in 1 µg/kg/min every 1-2 minutes to achieve an MAP at 55-65mmHg. Vital signs including heart rate will be recorded every 1 minute until the target MAP is achieved and then at 15 minute increments after that.

Eligibility Criteria:
Inclusion Criteria:

* Spinal fusion for neuromuscular scoliosis.

Exclusion Criteria:

* Allergy to dihydropyridine calcium channel antagonists
* Allergy to soy or eggs
* Non-neuromuscular causes of scoliosis
* Disorders of lipid metabolism (clevidipine is in a lipid base)
Special Drug Use-results Survey for Long-term Use (Fostamatinib)

The purpose of this survey is evaluating the safety and efficacy of long-term administration of fostamatinib for Japanese patients with chronic idiopathic thrombocytopenic purpura under actual conditions of use.

The purpose of this survey is evaluating the safety and efficacy of long-term administration of fostamatinib for Japanese patients with chronic idiopathic thrombocytopenic purpura under actual conditions of use.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic idiopathic thrombocytopenic purpura who are treatment with fostamatinib for the first time.
A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received Up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks

The primary objective of this study is to compare PFS (progression-free survival) rate at 6 months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks with nivolumab 240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC (non-Sq and Sq).


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histologically or cytologically documented Squamous or non-Squamous Non-small cell lung cancer (NSCLC) (Stage IIIB/IV), or recurrent or progressive disease following multimodal therapy
* Patients must have received pre-study nivolumab for up to 12 months and have 2 consecutive tumor assessments confirming Complete response (CR), Partial response (PR), or Stable disease (SD)
* Measurable disease before start of pre-study nivolumab treatment
* Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2

Exclusion Criteria:

* Carcinomatous meningitis
* Untreated, symptomatic Central nervous system (CNS) metastases
* Symptomatic interstitial lung disease

Other protocol defined inclusion/exclusion criteria could apply
Split-Face Study Comparing Botox and Jeuveau in Treating Glabellar Lines

The purpose of this study is to compare the efficacy and side effects of Botox and Jeuveau for glabellar lines.

After being informed about the study and potential risks, all patients given consent will receive Botox on one side of their face and Jueveau on the other. A random number generator will generate a list of 20 combinations of "1,2" or "2,1". "1,2" means the Botox (onabotulinumtoxin A) will be placed on the right side and "2,1" means that the Botox will be placed on the left. The other side will be injected with PrabotulinumtoxinA. 8-10 units will be injected into the designated glabella in 3 sites.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Willingness to participate in the study and able to provide informed consent

Exclusion Criteria:

* Inability to follow up for study duration
* Prior neurotoxin injection in the last 4 months
* Prior surgery to the glabellar area
* Any planned aesthetic procedure to the glabellar area during the study period
* Cardiac Patients
Environmental Temperature and White Adipose Tissue in Cancer Patients

The investigators aimed to retrospectively identify the association between the thermogenic capacity of white adipocytes and the environmental temperature, in cancer patients.

Obesity is characterized by excessive white adipose tissue (WAT) that increases risk for disease. About 700 million adults are obese worldwide, designating the need of reducing excessive WAT in humans and subsequently the risk for disease. For this reason, previous research focused on the thermogenic capacity of white adipocytes in response to cold exposure. Cold exposure represents a main stimulus for increased thermogenic capacity in human white adipocytes, which may have an impact on body weight loss and subsequently on obesity phenomenon.

In a cohort of 202 cancer patients (male=126), who undertook a Positron Emission Tomography (PET/CT), we retrospectively investigated the association between Tenv and thermogenic capacity of subcutaneous WAT (dorsolumbar region near vertebrae L3 and abdominal region). These patients undertook a PET/CT examination in order to define their disease status. They were given instructions in advance to refrain from smoking, exercise and excessive muscle stressors 24-hour prior to their examination. On the day of the measurements they advised to transport themselves by car to the PET/CT Laboratory between 08:00 am to 12 pm, following at least a 6-hour fasting. Patients were first injected an appropriate dose of 18F-FDG (based on their body weight) and then they were remained in a sitting relaxed position within a quiet room of 22-24°C for 60 minutes. Following this period, patients undertook the PET/CT examination, which included on average eight bed positions, while four minutes scanning per bed position was used.

PET/CT imaging analysis for WAT activity (dorsolumbar region near vertebrae L3 and abdominal region) was performed by two independent trained physicians, using previous methodology.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients who undertook a PET/CT examination independently of their disease status

Exclusion Criteria:

* Examinations prior to 2016
To Study The Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction in Decompensated Cirrhotics Undergoing Less Than 5 Litres Of Ascitic Fluid Tap With Or Without Albumin Infusion.

All consecutive patients admitted in ILBS from MAY 2015 to DECEMBER 2016. Decompensated cirrhosis patients will be randomized into Group 1: MVP (Moderate Volume Paracentesis) of less than 5 litres with iv albumin at a dose 8 gms/l of ascitic fluid Group 1: MVP (Moderate Volume Paracentesis) of less than 5 litres without albumin .


Eligibility Criteria:
Inclusion Criteria:

1. All Cirrhotics decompensated with ascites admitted in the hospital.
2. Grade II/III ascites
3. Need for paracentesis.

Exclusion Criteria:

1. Age \<12 or \> 75 years
2. Hepatocellular carcinoma
3. Non cirrhotic ascites such as malignancy or tubercular peritonitis
4. Serum Cr \>1.5mg%
5. Refractory septic shock
6. Grade III/IV hepatic encephalopathy
7. Abdominal wall cellulitis
8. Active variceal bleed
9. Respiratory, cardiac and renal failure
10. Refusal to participate in the study
BCI-controlled NMES in Subacute Stroke

Stroke patients with severe upper limb movement deficits have limited treatment options and often remain severely handicapped at the chronic stage.

Recent findings have suggested that poor motor recovery can be due to severe damage of the cortico-spinal tract (CST), the neural fibres connecting the movement regions of the brain to the spinal cord. Hence, to improve recovery of upper limb movements it will be crucial to re-establish and strengthen CST projections.

Recent studies provided evidence that closed-loop brain computer interface-driven electrical stimulation of the paretic muscles can induce clinically important and lasting recovery of upper limb function, even in patients with chronic, severe motor affection. In this treatment approach, movement intentions of the patients are detected with electroencephalography and real-time analyses. This triggers an electrical stimulation of affected upper limb muscles.

In this study, the investigators hypothesize that neuromuscular electrical stimulation (NMES) applied contingent to voluntary activation of primary motor cortex, as detected by a brain-computer interface (BCI), can help restore CST projections. This might improve recovery of patients with severe upper limb movement deficits. Treatment will be started within the first 8 weeks after stroke onset.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic or hemorrhagic stroke
* Stroke onset ≤ 8 weeks
* Severe, unilateral motor upper extremity hemiparesis (≤15 Fugl-Meyer Score)
* Ability to give informed consent

Exclusion Criteria:

* Second stroke during rehabilitation
* Skull breach
* Cardiac pacemaker
* Metallic implants in the brain
* Delirium or disturbed vigilance
* Inability to follow treatments sessions
* Severe language comprehension deficits
* Severe dystonia or spasticity
* Severe co-morbidity (ex, traumatic, rheumatologic, neurodegenerative diseases)
* Pregnancy