cyrilzakka/clinical-trials huggingface dataset:
A Study to Find Out How Nusinersen is Processed in the Body When Given Through the ThecaFlex DRx™ System in Adult and Pediatric Participants With Spinal Muscular Atrophy (PIERRE-PK)

In this PIERRE-PK study, researchers will learn how the body processes nusinersen when it is given through the ThecaFlex DRx™ System, compared to when nusinersen is given by lumbar puncture (LP). The ThecaFlex DRx system is an investigational implantable medical device developed by Alcyone Therapeutics, Inc. It consists of a catheter, which is a flexible tube, connected to a port which is placed under the skin. Alcyone Therapeutics, Inc. has an ongoing study called PIERRE to test the ThecaFlex DRx system. Participants with spinal muscular atrophy (SMA) in the PIERRE study may be enrolled in the PIERRE-PK study.

The main objective of the PIERRE-PK study is to learn how the body processes nusinersen when given by the ThecaFlex DRx system compared to a lumbar puncture. The main questions researchers want to answer are:

* What is the highest amount of nusinersen found in the blood after dosing?
* How much nusinersen is found in the blood over the first 24 hours after dosing?

The PIERRE-PK study will be done as follows:

* Participants will be screened to check if they can join the study. The screening period will be up to 30 days for this study and may overlap with the PIERRE study.
* Participants will receive a dose of nusinersen by lumbar puncture.
* The ThecaFlex DRx system will be implanted after the lumbar puncture, as part of the PIERRE study.
* Participants will receive a dose of nusinersen by the ThecaFlex DRx system, as part of the PIERRE study.
* Researchers will take blood samples before and after each dose. The last blood sample will be taken 24 hours after the dose.
* The total study duration for each participant in the PIERRE-PK study will be up to 5 months. This period will overlap with the participant's first 5 months in the PIERRE study.


Eligibility Criteria:
Key Inclusion Criteria:

* Participant is on regular maintenance dosing of nusinersen (12 milligrams \[mg\] dose) every 4 months, with 4 months (± 2 weeks) between the LP-delivered study dose and the last nusinersen dose prior to study enrollment.
* Participants must be enrolled in the PIERRE study to be eligible for enrolment in the PIERRE PK study

Key Exclusion Criteria:

* Ongoing participation or participation within 6 months or 5 half-lives of the agent (whichever is longer) of enrolment in other interventional clinical trials for the treatment of SMA (except for the PIERRE study).
* Participant is naïve to nusinersen treatment.
* Participant is receiving nusinersen at a dose other than 12 mg.
* Participant has already undergone implantation of the ThecaFlex DRx system.
* Participant is pregnant, currently breastfeeding, or intending to become pregnant during the study.

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply
Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control

To investigate efficacy, safety and tolerability of BI 1356 versus placebo


Eligibility Criteria:
Inclusion criteria:

* Male or female patients with type 2 diabetes and insufficient glycaemic control.
* Age 18 or over and not older than 80 years

Exclusion criteria:

* Use of more than one oral antidiabetic agent within 10 weeks prior to informed consent, insulin, glitazones or GLP-1 analogues within 3 months.
* Myocardial infarction, stroke or transient ischaemic attack within 6 months prior to informed consent.
BEST (Burn Center Evaluation of Standard Therapies) Ventilator Mode Study-

The purpose of this study is to compare High Frequency Pressure Ventilation (HFPV) to conventional mechanical ventilation.

Hypothesis: Patients placed on HFPV will have significantly higher number of ventilator-free days compared to patients placed on a conventional volume mode.

This is a prospective, randomized, controlled trial comparing HFPV to conventional ventilator modes in the support of burn patients with respiratory failure. Burn patients who develop the need for mechanical ventilation present a variety of challenges that call for innovative therapeutic options. Even in the absence of smoke inhalation injury,decreased chest wall compliance from full thickness burns as well as massive fluid requirements are just a few variables that make it difficult to achieve gas exchange goals when attempting to apply conventional lung protective strategies recommended by the ARDS Net investigators.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are deemed to require ventilatory support for more than 24 hours from the time of screening.

Exclusion Criteria:

* Anticipated extubation within 24 hours of screening
* Patients who are pregnant Patients not expected to survive for more than 24 hours
Concurrent Nab-P/Carboplatin and Thoracic Radiotherapy in Squamous Cell Lung Cancer

Nab-paclitaxel and carboplatin showed better treatment response compared with cremophor-based paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer, especially for squamous cell cancer. The regimen of weekly nab-paclitaxel, carboplatin and concurrent radiotherapy was well tolerated in a phase I study. Given nab-paclitaxel, carboplatin and concurrent radiotherapy in patients with local advanced squamous cell lung cancer may have promising result.

This study was conducted to explore the efficacy and toxicity of concurrent chemoradiotherapy with nab-paclitaxel, carboplatin and thoracic radiotherapy in unresectable local advanced squamous cell lung cancer. Patients will be given nab-paclitaxel weekly at a dose of 60mg/m2, in combination with carboplatin (AUC 2) weekly during concurrent chemoradiotherapy. Thoracic radiation was administered at a dose of 66 Gy/33 fractions, both 3 dimensional conformal and intensity modulated radiation therapy are allowed. Two cycles of consolidation therapy with full dose nab-paclitaxel (260 mg/m2 on day 1) and carboplatin (AUC 6 on day 1) every 21 day will be delivered.

Eligibility Criteria:
Inclusion Criteria:

* Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
* Previously untreated, histological documented, inoperable stage IIIA or IIIB squamous cell carcinoma of lung, excluding those with pericardial, pleural effusion, and those with contralateral hilar or contralateral supraclavicular lymph nodes.
* Patients must have measurable disease according to RECIST criteria, and all detectable tumor can be encompassed by radiation therapy fields.
* Weight loss ≦ 5% in the previous six months.
* Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
* Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
* Patients must sign a study-specific informed consent form prior to study entry.

Exclusion Criteria:

* Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
* Previous chemotherapy or previous biologic response modifiers for current lung cancer.
* Patient has previously had thoracic radiation therapy.
* Prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for five years or more.
* Serious concomitant disorders that would compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator.
* History of significant neurological or mental disorder, including seizures or dementia.
PENG Block With Two Diffirent Volume

Hip fractures are morbid conditions, especially in elderly patients, and their treatment is usually surgical. Pericapsular nerve group block is a newly defined block and targets the hip capsule. The aim of this study is to investigate and compare the perioperative analgesic efficacy of PENG blocks applied in two different volumes in patients undergoing hip fracture surgery under spinal anesthesia.

Hip fractures are morbid conditions, especially in elderly patients, and their treatment is usually surgical. Pericapsular nerve group block is a newly defined block and targets the hip capsule. The aim of this study is to investigate and compare the perioperative analgesic efficacy of PENG blocks applied in two different volumes in patients undergoing hip fracture surgery under spinal anesthesia.

60 ASA I-III patients between 35-90 years of age who will be operated for femoral head/neck fractures will be included in the study. US-guided block procedure will be applied 30 minutes before the start of surgery. The patients will be divided into two groups, Group I, PENG block 20ml bupivacaine (n:30) and Group II, PENG block 30ml bupivacaine (n:30) using the closed envelope method in the operating room. Randomization will be performed by one of the researchers for each patient. Randomization information of patients will be used for all follow-up and data collection. The anesthetist applying the block will not take any part in collecting the data or performing the analysis. Numerical rating scale (NRS) will be used to evaluate pain. Patients will be given spinal anesthesia 30 minutes after PENG block. The primary outcome measure was determined as pain during positioning. NRS scores will be recorded after entering the operating room before, immediately before, during, and immediately after any analgesic intervention. Secondary outcome measures will be determined as the time required for LA performance (measured from the start of the position maneuvers to removal of the spinal needle), the quality of the patient position for LA performance ("unsatisfactory", "satisfactory", "good", "very good" to define SA). Questionnary 15 test will be applied to the patients 24 hours after the operation to measure patient satisfaction and to measure patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for total hip replacement surgery under spinal anesthesia
* ASA(American Society of Anesthesiology) 1-3
* Receiving consent that accept regional analgesia

Exclusion Criteria:

* contraindications for spinal anesthesia and PENG block
* impaired cognition or dementia
* multiple fractures
Development of the Eating Behaviour Lapse Inventory Survey Singapore (eBLISS):An Exploratory Mixed-method Study

An exploratory mixed-method study will be conducted to develop an instrument for early detection and prevention of overconsumption.


Eligibility Criteria:
Inclusion Criteria:

1. Above the legal age of 21 years old
2. Have a BMI ≥ 23kg/m2
3. Able to understand and read English language
4. Uses a smart phone that can download apps
5. Able to provide informed consent

Exclusion Criteria:

1. Diagnosed with a pre-existing psychological disorder such as anxiety and depression except binge eating disorder
2. Participating in a concurrent weight management intervention that is beside the usual care
GALLANT 4 Tesaglitazar vs. Glibenclamide

This is a 52-week randomized, double-blind, parallel-group, multi-center, active-controlled (glibenclamide) study of tesaglitazar in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 6 week placebo single blind run in period followed by a 52-week double blind treatment period and a 3-week follow-up period. Tesaglitazar and glibenclamide will be titrated to optimal effect or highest tolerable dose during the first 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Provision of a written informed consent
* Men or women who are \>=18 years of age
* Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
* Diagnosed with type 2 diabetes
* Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents

Exclusion Criteria:

* Type 1 diabetes
* New York Heart Association heart failure Class III or IV
* Treatment with chronic insulin
* History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
* History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
* Creatinine levels above twice the normal range
* Creatine kinase above 3 times the upper limit of normal
* Received any investigational product in other clinical studies within 12 weeks
* Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
Pilot Study of Virtual Gait Training in Older Adults

Older individuals suffer from falls and fear of falling. The purpose of this study was to determine the effectiveness of a novel virtual gait training on walking performance and fear of falling in older adults, and to evaluate the feasibility of the virtual gait training program. The investigators hypothesize that virtual gait training in older adults over a three week period will both improve gait parameters as measured by a GAITRite® electronic walkway system, and reduce their fear of falling as measured by the Falls Efficacy Scale-International version.

The objectives of this study are to determine the effectiveness of virtual gait training on walking performance and fear of falling in older adults and to evaluate the feasibility of the virtual gait training. This prospective interventional study plans to include twelve residents of senior assisted living facilities in Basel, Switzerland, aged 65 years or older with no severe physical or cognitive disabilities, and who had fallen at least once in the preceding 12 months. Each participant will complete 14 12-minute virtual gait training sessions within a three-week period. Gait parameters will be quantified with the GAITRite® electronic walkway system, and fear of falling evaluated with the Falls Efficacy Scale-International version. The investigators hypothesize that 14 virtual gait training sessions in older adults over a three week period will both improve gait parameters as measured by a GAITRite® electronic walkway system, and reduce their fear of falling as measured by the Falls Efficacy Scale-International version.

Eligibility Criteria:
Inclusion Criteria:

* older than 65 years of age
* fall within last 6 months

Exclusion Criteria:

* cognitive deficits
* physical disability
Bridging the Treatment Gap by Expanding Access to Care for People with Epilepsy in Kenya (BEACON)

This cluster randomized trial aims to learn about the effectiveness of task-sharing supported by an epilepsy medical records system (EMRS) (hereafter referred to as BEACON) with patient-tracking data in improving treatment adherence and retention in care in people with epilepsy in western Kenya.

Epilepsy is a serious neurological condition and a major cause of morbidity and mortality. Globally, epilepsy prevalence is highest in sub-Saharan Africa, and Kenya has a high disease burden. Delay in treatment initiation and non-adherence increase disease-related burden in terms of low quality of life, high healthcare costs, risk for seizure-related injuries, and premature death

The BEACON intervention is grounded in existing evidence-based intervention. Task-sharing, an intervention advocated by the World Health Organization and the Institute of Medicine. Researchers will compare patients receiving the BEACON intervention to those receiving usual care to see if there are any differences in treatment adherence and retention in care between the groups. Researchers will test BEACON's ability to: (1) improve care retention and treatment adherence; and (2) reduce seizure severity and perceived stigma and improve quality of life (QoL). The cost-effectiveness of the intervention will also be assessed. Data will be collected at baseline, 12 and 18 months (if warranted).

This project will also build clinical and research capacity for epilepsy work in western Kenya.

Eligibility Criteria:
Inclusion Criteria:

* Individuals ≥12 years
* Residents of Busia or Trans Nzoia County
* Diagnosed with possible epilepsy through initial screening and confirmed diagnosis by an epilepsy-trained professional with the BEACON project or physician
* Have a diagnosis of epilepsy but are not adherent to antiseizure medication treatment.

Exclusion Criteria:

* Individuals receiving care from a neurosurgeon or neurologist for a serious brain disorder
* Unable or unwilling to provide voluntary informed consent or assent (12-18 years)
Choline Supplementation As a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study

This is a randomized, double-blind controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The study is comparing two administration durations (3 months vs. 6 months) of choline. The primary outcome measures are cognitive measures.

This project is the fourth in a series of randomized, double-blind controlled trials of choline bitartrate in children ages 2-5 (under 6) years with prenatal alcohol exposure. Pre-clinical data suggests that choline may attenuate the cognitive deficits caused by prenatal alcohol exposure (especially memory deficits). This study will evaluate the effects of daily choline supplementation in two dosing regimens (3 months choline vs. 6 months choline). Outcome measures include an elicited imitation memory paradigm, IQ measures, and measures of memory and executive functioning, and behavior.

Eligibility Criteria:
Inclusion Criteria:

* Ages 2.5 years to 5 years old (\<6 years of age) at enrollment
* Prenatal alcohol exposure
* Available parent or legal guardian capable of giving informed consent for participation.

Exclusion Criteria:

* History of a neurological condition (ex. epilepsy, traumatic brain injury)
* History of a medical condition known to affect brain function
* Other neurodevelopmental disorder (ex. autism, Down syndrome)
* History of very low birthweight (\<1500 grams)
Brain Blood Vessel Responses to Changes in Blood Flow

Brain blood flow will be measured during a simulated postural change test and while breathing increased levels of carbon dioxide using magnetic resonance imaging.

Global cerebral blood flow (CBF) decreases with advancing age; however, some adults have accelerated declines in CBF, placing them at a greater risk of cognitive impairment. However, there is a lack of human studies that investigate the cause or consequence of altered blood flow regulation in the brain. This study will systematically address this gap in knowledge by examining cerebrovascular control in adults during acute physiological challenges (simulated postural change test and breathing increased carbon dioxide) that stimulate a change in CBF.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 55-69 years
* Have a BMI ≤34.5 kg/m2
* Nonsmoker
* Females must be postmenopausal

Exclusion Criteria:

* Diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's disease (AD)
* History or evidence of hepatic disease, hematological disease, or peripheral vascular disease; severe kidney injury requiring hemodialysis
* History of cardiovascular disease including: severe congestive heart failure, coronary artery disease, ischemic heart disease (stents, coronary artery bypass grafts) and tachycardia
* Uncontrolled hypertension
* History of clinically significant ischemic or hemorrhagic stroke, or significant cerebrovascular disease
* Severe untreated obstructive sleep apnea
* History of diabetes with HbA1c greater than 9.5%
* Major neurologic disorders other than dementia (e.g., MS, ALS, brain surgery, etc.)
* Current or recent (\&amp;lt;1 year) major psychiatric condition (Axis I) or addictive disorders
* Significant surgical history
* Other significant medical conditions at investigators' discretion
* Contraindications to MRI
* Prescribed medications that interfere with prazosin
* Lactose allergy
Azithromycin in Combination With Chloroquine Versus Chloroquine in the Eradication of Asymptomatic Plasmodium Falciparum

The purpose of this study is to determine if Azithromycin in combination with chloroquine is superior to chloroquine alone in eradicating P. falciparum asexual parasitemia in asymptomatic, semi-immune adults in Western Kenya.

The trial was terminated prematurely 9 November 2004 due to the inability to recruit the planned number of subjects. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult: male or female
* Asymptomatic mono-infection with P. falciparum parasitemia with a parasite density of 1000 - 30,000 parasites/Î¼L
* Age 18 years to 60 years
* Willingness to sign and ability to understand consent form
* Willingness and ability to return for scheduled follow up visits

Exclusion Criteria:

* Mixed malaria infection by Giemsa smear
* History of allergy to or hypersensitivity to chloroquine, Azithromycin or other macrolides (e.g. erythromycin, clarithromycin)
* Any of the following: a.) Antimalarial therapy administered in the past 4 weeks, including quinine therapy or an artemisinin derivative; or b.) An antibacterial with known antimalarial activity (including, erythromycin, doxycycline, clindamycin, cotrimoxazole) within one week prior to enrollment into the study
* Fever, history of fever in past 48 hours, or signs/symptoms of malaria (including acute or subacute headache, nausea, or vomiting)
* Inability to swallow oral medication
* Laboratory evidence or history of significant cardiovascular, liver, hematologic or renal functional abnormality
* Any situation which could prevent the patient from returning to follow up visits
* Pregnancy or breast feeding
* Any other concurrent illness that may confound the result
* Any other condition or circumstance that in the opinion of the Investigator may pose a threat to the study participant or study