cyrilzakka/clinical-trials huggingface dataset:
Rebound Exercise in Neurological Disorders

This study will be a pretest-posttest interventional trial investigating the use of rebound exercise in community-dwelling individuals with neurological disorders.

Neurological disorders are linked to various problems, including but not limited to movement impairments, balance, fear of falls, reduced exercise tolerance, loss of muscle strength, reduced functional independence, sedentary behaviour and reduced quality of life. These impairments can lead to physical deconditioning, functional dependency and extreme disability if left unmanaged, creating the need for prompt treatment. Rebound exercise is an effective and safe form of aerobic exercise that has been successfully used in some populations. It can be included in rehabilitating people with neurological disorders for its beneficial effects on humans and minimal stress on the heart and joints. Its fun-giving experience makes it easier to engage regularly compared to traditional exercise tools that may feel like a task. It is also more affordable and less time-consuming than other standard modalities. The few available studies on rebound exercise in neurological disorders were mostly in inpatients, and evidence is scarce on the use of rebound exercise in community-dwelling individuals with neurological disorders. It is thus necessary to investigate its use in the community context as well as the minimal effective dosage of the intervention. This study will investigate the frequency of rebound exercise necessary to effect changes in physiological and functional outcomes such as heart rate, blood pressure, physical activity level, walking speed, risk of falls, cognitive function and quality of life. The enrolled participants will undergo 12 weeks of rebound exercise training once or twice weekly, depending on their frequency choice.

Ethical approval has been sought and obtained from the Research Ethics Committee of Buckinghamshire New University. Eligible volunteer participants will be asked to sign the informed consent after the study has been explained to them. They will be assured of data confidentiality by anonymising their information and will also be informed of their right to withdraw at any point.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of a neurological disorder of upper motor neurone origin such as stroke, multiple sclerosis, Parkinson's disease, traumatic brain injury etc
* must score 3 or less on the Modified Rankin Scale for disability status
* must be able to walk with or without walking aids for at least 2 minutes
* have a body weight of \<120 kg
* must be able to understand therapy instructions.

Exclusion Criteria:

* Pregnancy
* Other significant comorbidities
* cardiovascular or respiratory system disorders
* musculoskeletal disorders
* visual or auditory sensory disorders.
* cancer
* genu recurvatum
Analysis of Cisatracurium Consumption in Balanced Anesthesia With 1% Sevoflurane, and With Only Sevoflurane, Using a Closed-loop Computer Controlled System Infusion.

The aim in this study was to quantify the difference in cisatracurium and sufentanil consumption, and its recovery period, when patients are under balanced general anesthesia with 1% sevoflurane and patients under only sevoflurane general anesthesia, using a closed loop computer control infusion. Investigators further investigated this effect on its recovery period and sufentanyl consumption.

156 patients of American Society of Anesthesiologists (ASA) physical status I and II were assigned to three groups. The patients were all on schedule for elective general surgery under general anesthesia with duration of at two to four hours. All patients were induced with Etomidate (0.2mg/kg), Midazolam (0.05-0.1mg/kg), Sufentanil (0.3-0.5µg/kg) and a bolus dose of Cisatracurium (0.15mg/kg). Patients were aged between 20 and 65. The maintenance of anesthesia in each group varies as follows: Patients in Group 1 were all maintained with Total Intravenous Anesthesia, Group 2 with Sevoflurane at 1% and propofol infusion, Group 3 with only sevoflurane. Muscle paralysis is maintained using a closed-loop computer gated infusion of Cisatracurium which kept T1 \<1% by giving increasing the infusion rate intra-operatively when required. Analgesia was maintained by intermittent bolus dose of 10-20 µg of Sufentanil.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20 and 65.
* Patients with ASA 1 and 2.
* Patients for elective abdominal general surgery

Exclusion Criteria:

* Patients with the following diseases are excluded, since they are known to cause generalized neuromuscular weakness:

Neuromuscular junction disorders (e.g.. myasthenia gravis) Myopathies (e.g.. Muscular Dystrophies, Rhabdomyolysis) Peripheral Neuropathies (e.g. Guillain-Barre Syndrome, Polyneuropathies) Encephalopathies (Septic and Toxic-metabolic Encephalopathy) Patients with renal and liver diseases.

* Patients who are sent intubated to ICU after surgery.
* Patients refusal
Care Outcomes in Preterm Infants Following the Implementation of Family-centered Interventions

The proposed study evaluates the effects of two family-centered interventions on the length of stay and outpatient visits and growth of preterm infants.The interventions are 1) the Close Collaboration with Parents training for the staff and 2) moving from traditional neonatal intensive care unit architecture to single-family room architecture.

The Close Collaboration with Parents training targeted to the health care team of neonatal intensive care units to facilitate parental involvement in infant care and to support parenting. The training program involves a structured education process, where trained mentors educate staff in neonatal units. The duration of the training program is 18 months per unit. The training program has been implemented in eleven neonatal units in Finland since 2009; another 12 units haver not gone through the training.

The other intervention, single-family room architecture, provides facilities for parents to stay in the room of their infant throughout there 24 hour day. This intervention has been carried out in four neonatal units in Finland since 2014; in one by restructuring the existing unit, and in three by building a new unit/hospital.

In this study, the investigators are going to use national, population-based registers (the Medical Birth Register, the small Preterm Infant Register and the Hospital Discharge Register) governed by the Finnish National Institute for Health and Welfare. These registers have been widely used for observational studies, and contain data on all newborn infants in the country.

There are currently 23 neonatal units in Finland. Three units have undergone both interventions, nine units have undergone one intervention, and 12 units have undergone neither. Preterm infants (born before 35 gestational weeks) discharged from any unit will be divided into those who have been cared for all, part or no time in a hospital with an intervention, separately for each intervention. The outcome measures of interest will be related to health care utilization such as the length of stay and unscheduled outpatient visits, and to clinical outcomes such as postnatal growth parameters.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants (gestational age \<35 weeks) born in Finland between 2006 and 2020

Exclusion Criteria:

* Missing data on key variables (gestational age, place of birth, length of stay)
: SOCKET SHIELD TECHNIQUE VERSUS EMPTY SOCKET TECHNIQUE

To evaluate the clinical and radiographic outcomes of socket shield technique compared with conventional immediate implant placement.

To evaluate the clinical and radiographic outcomes of socket shield technique compared with conventional immediate implant placement.

PICO

* P: patient require immediate dental implant placement for esthetic consideration
* I: socket shield technique
* C: conventional immediate implant placement
* O:

Outcome name Measuring device Measuring unit Primary outcome Vertical and horizontal bone level Cone beam Computer Tomography (CBCT) Millimeter Secondary outcome (a) Pocket probing depth Periodontal probe Millimeter Secondary outcome (b) Labial Alveolar crestal bone height compared with the lingual side Cone beam Computer Tomography (CBCT) Millimeter

Eligibility Criteria:
Inclusion Criteria:

1. Patients with remaining roots in the esthetic zone with intact periodontal condition indicated for extraction.
2. Physically able to tolerate conventional surgical and restorative procedures
3. Signing of an informed consent form
4. Implant insertion torque \> 32 N cm with good primary stability

Exclusion Criteria:

1. Systemic diseases contraindicating implant placement eg uncontrolled diabetes
2. Severe bruxism
3. Active infection in the teeth to be treated
4. Vertical root fractures with displacement in the teeth of the surgical area
Home Based Exercise Program for Brain Injury Children

The purpose of this study is to examine whether simple home-base aerobic exercise program have beneficial effect on walking abilities and balance performance in children with brain damage


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of CP or ABI Must be able to stand with or without aid.

Exclusion Criteria:

Can not follow simple commands
Validation of a Prediction Model for Inadequate Bowel Preparation

We have developed a novel inadequate bowel preparation prediction model based on a systematic review and meta-analysis. The goal of this observational study is to validate the accuracy of this model.

A total of 615 patients undergoing colonoscopy will be enrolled. The primary outcome is quality of bowel preparation. The secondary outcomes include polyp/adenoma detection rate, willingness of undergoing colonoscopy again and adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. adult patients (age is ≥18 years old);
2. patients undergoing colonoscopy;
3. written informed consent.

Exclusion Criteria:

1. patients undergoing emergent colonoscopy;
2. patients with major psychiatric disorders;
3. pregnant or breast feeding patients;
4. patients with contraindications for colonoscopy (e.g., heart failure, renal insufficiency);
5. patients suspected to have intestinal obstruction, stenosis or perforation;
6. patients previously enrolled in this study.
Respiratory Kinematics of Cough in Healthy Older Adults and Parkinson's Disease

The purpose of this research study is to test cough function in individuals with Parkinson's disease and healthy older adults. Cough is a complex, defensive function which involves movement of the chest and lungs. The investigators want to compare the movement of the chest wall and the lungs during voluntary and reflex cough.

The long-term goal of this research is to develop treatments for people with cough dysfunction. Cough dysfunction increases the risk for respiratory infections such as pneumonia. The results from this study will provide information to help researchers understand the difference between reflex and voluntary cough more fully.

If the participant agrees to participate, the investigators will first test pulmonary (lung) function. Next, the investigators will test voluntary and reflex cough. After this first round of cough testing, the investigators will ask participants to cough long and hard during voluntary and reflex cough testing. Finally, the investigators will view the larynx (voice box) with an endoscopic camera inserted through the nose. This test is done to see if there are any changes in the larynx that may influence cough.

Eligibility Criteria:
Inclusion Criteria:

* Age 55-85 years
* Ability to provide informed consent

For participants with Parkinson's disease (PD):

- Diagnosis of PD (Hoehn \& Yahr stages II-IV) by a University of Florida Movement Disorders fellowship trained neurologist having completed a clinical assessment of each participant's PD severity and arriving at the diagnosis of PD by applying strict United Kingdom brain bank criteria.

Exclusion Criteria:

Participants with PD:

- History of neurological disorders other than PD (e.g. multiple sclerosis, stroke, brain tumor, etc)

Healthy older adults:

* History of neurological disease including PD
* History of head and neck cancer
* History of breathing disorders or disease (i.e. chronic obstructive pulmonary disease, asthma)
* History of smoking for more than 5 years at any one time (as this reduces the sensitivity to capsaicin)
* History of chest infection the last 5 weeks
* Failure of a screening test of pulmonary function (e.g. forced expiratory volume in one second/forced vital capacity\<75%)
* Difficulty complying due to neuropsychological dysfunction (i.e. severe depression)
Clopidogrel High Dose Evaluation for the Patient With Coronary Artery Disease in Japan

The purpose of this study is to evaluate the effect of high dose clopidogrel as the antiplatelet therapy on inhibition of platelet aggregation in Japanese patients scheduled for percutaneous coronary intervention due to ischemic heart disease.

Dual antiplatelet therapy of aspirin and thienopyridine is used to prevent stent thrombosis after percutaneous coronary intervention (PCI). Clopidogrel is the most popular thienopyridine. Following the 300mg clopidogrel loading dose (LD) at first day, patients take 75mg maintenance dose (MD) to inhibit platelet aggregation after coronary stent implantation. 600mg high LD inhibit platelet aggregation more rapidly and strongly than standard LD and prevent thrombotic event around the PCI. Similarly high MD inhibit platelet aggregation more strongly. Interindividual variability of clopidogrel anti-platelet effect has been reported. In Japanese, there are many non or hyporesponders to clopidogrel compared to the Western population. The purpose of this study is to evaluate the effect of high dose clopidogrel as the antiplatelet therapy on inhibition of platelet aggregation in Japanese patients scheduled for PCI due to ischemic heart disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for percutaneous coronary intervention due to ischemic heart disease
* Patients taking aspirin 81-100mg at least 1 week.

Exclusion Criteria:

* Patients with ST elevation myocardial infarction
* Patients have contraindication of aspirin or clopidogrel
* Patients taking warfarin
* Patients received thrombolytic therapy within 2 weeks
* Patients taking anti-platelet agents except aspirin within 1 month
* Patients taking corticosteroid.
* Patients taking proton pump inhibitor
Fast-Acting Subperception Study (FAST)

Study to Demonstrate the Value of Fast-Acting Subperception (FAST) using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain


Eligibility Criteria:
Key Inclusion Criteria:

* Chronic pain of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain.
* 22 years of age or older at time of enrollment
* Able to independently read and complete all questionnaires and assessments provided in English
* Signed a valid, IRB-approved informed consent form (ICF) provided in English

Key Exclusion Criteria:

* Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes
* Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
* Breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception
* Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study
Umbilical Cord Care for the Prevention of Colonization

Umbilical catheters are necessary for many infants admitted to the Newborn Intensive Care Unit (NICU)and utilized when indicated for up to 7 to 14 days. Bacterial colonization can occur at the umbilical stump and potentially lead to serious bloodstream infections (BSIs). This study is a prospective, randomized controlled feasibility trial to evaluate three types of hygiene products on umbilical line stumps, on the effect of line colonization and subsequent infections. Infants admitted to the NICU with an umbilical line(s) will be randomized into one of four study groups, three products against standard of care (no product). The three products that will be evaluated are currently being used in different capacities for skin care in the University of Virginia (UVA) NICU. The study hypothesizes that twice daily topical application of 1 or more antiseptic to the top of the umbilical stump will decrease colonization of the umbilical stump while umbilical lines are in place.

Umbilical catheter associated infections are higher (4.4 vs. 3.4 CLABSIs per 1000 line days) than other central lines such as peripherally inserted central catheters (PICCs) and surgically placed central venous lines (CVL) in the NICU. (www.CDC.gov - NSHN 2010 Report). Routine care of the skin entry site (e.g. central line dressing care) is standard for other central lines, but there is no standard for care of the umbilical stump while umbilical lines are in place.

In a pilot study to evaluate the relationship of umbilical stump colonization with gestational age, the number of days the catheter was in place, and the type of organisms, colonization was detected in 78% of patients. There was a direct correlation with colonization and line days as well as an inverse relationship with lower gestational age.

This pilot data supported the need for the study of interventions to reduce umbilical stump colonization, which may help decrease blood stream infections (BSIs) associated with umbilical lines in the NICU. The proposed study will evaluate feasibility of twice daily product application.

Eligibility Criteria:
Inclusion Criteria:

\*≤7 days of life

\*Umbilical line(s) in place (Umbilical arterial catheter=UAC and/or Umbilical venous catheter=UVC)

Exclusion Criteria:

\*Not meeting inclusion criteria
Efficacy and Safety of 2 Raltegravir Doses in Naive HIV-1-infected Patients Receiving Rifampin for Active Tuberculosis

Raltegravir is a potent antiretroviral agent that could be used as an alternative to efavirenz in HIV-1 infected patients with tuberculosis. However due to pharmacokinetic interactions, the optimal dose of raltegravir to be used in combination with rifampin is currently unknown.

This phase II open-label randomized multicenter trial is designed to estimate the antiviral efficacy of two doses of raltegravir and one dose of efavirenz at week 24, in HIV-1 naive patients co-infected with active tuberculosis (TB) treated with rifampin.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (at least 18 years old)
* Plasma HIV RNA \> 1000 copies/ml
* HIV-1-infection confirmed by ELISA and Western blot or Immunofluorescence
* ART naïve patients or
* ART for less than 3 months and more than 6 months ago ; an HIV resistance genotype at baseline showing no mutation to NNRTI and TDF or 3TC will be required
* For women of childbearing age, negative urinary test for pregnancy and to accept contraceptive methods: condom use and intra-uterine device when possible or declare no wish of pregnancy in the coming year.
* Confirmed or probable TB
* TB treatment including rifampin started since 2 to 8 weeks before randomisation
* Signed informed consent form
* For French patients, to be affiliated to the National Health Care System

Exclusion Criteria:

* HIV-2 infection (single or with HIV-1)
* Woman who is pregnant or likely to become so, is breastfeeding or refuses to use contraception
* ALT\>2.5N, Hb \<7g/dl, neutrophils \< 750/mm3, platelet\<50 000/mm3, bilirubin \>5N, lipase \>3N
* Creatinine clearance \<60ml/min as assessed by the Cockcroft method
* Ongoing psychiatric pathology or any condition (including, but not limited to, the consumption of alcohol or drugs) which might, in the investigator's opinion, compromise the safety of treatment and/or patient compliance with the protocol
* Concomitant treatments including phenytoin or phenobarbital (compounds interacting with UGT1A1)
* Prior TB with a Mycobacterium tuberculosis strain resistant to rifampin
* TB treatment started for more than 8 weeks before randomisation
Fertility-sparing Management Using High-dose Oral Progestin in Young Women With Endometrial Cancer

This registry aims to evaluate the efficacy of using high-dose oral progestin in young women with stage I endometrial adenocarcinoma with grade 2 differentiation or superficial myometrial invasion as a fertility-sparing management.

The standard treatment for endometrial cancer is total hysterectomy and bilateral salpingo-oophorectomy, peritoneal cytology, and lymph node dissection. However, young patients who desire to preserve their potential for fertility may find this standard treatment difficult to accept. Therefore, the conservative treatment for these patients has remained a challenge. A number of studies have reported the effectiveness of hormonal therapy using systemic progestin in women clinically diagnosed with early endometrial adenocarcinoma at stage IA, grade 1, who want to maintain reproductive potential. However, there have been few prospective studies about hormonal therapy in young women with stage I endometrial adenocarcinoma with grade 2 differentiation or superficial myometrial invasion as a fertility-sparing management.

\[Primary endpoint\]: To evaluate the complete response rate \[Sencondary endpoint\]: To evaluate of disease-free survival rate, fertility outcomes and side effects of high-dose oral progestin.

To analyze predictive and prognostic biomarkers and clinicopathologic factors about response and recurrence after therapy, To analyze patient-reported outcomes.

\[TREATMENT METHODS\] Patients with histologically confirmed grade 1 endometrioid adenocarcinoma with superficial myometrial invasion or patients with histologically confirmed grade 2 endometrioid adenocarcinoma that is presumably confined to the endometrium or patients with histologically confirmed grade 2 endometrioid adenocarcinoma with superficial myometrial invasion are administered medroxyprogesterone Acetate(MPA) at a dosage of 500 mg/day for 12 months.

Follow-up and treatment response assessment were implemented at a 3-month interval with MRI and dilatation and curettage (D\&C) procedure. The biopsy findings are compared.

\[INVESTIGATIONAL PRODUCT\] General Name/Brand name:Farlutal tab. 500mg/ Pfizer

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed grade 1 endometrioid adenocarcinoma with superficial myometrial invasion based on Magnetic resonance image(MRI)
* Patients with histologically confirmed grade 2 endometrioid adenocarcinoma that is presumably confined to the endometrium based on MRI
* Patients with histologically confirmed grade 2 endometrioid adenocarcinoma with superficial myometrial invasion based on MRI
* Patients who desire to preserve fertility potential
* Patients signed the written informed consent voluntarily

Exclusion Criteria:

* Patients who have severe underlying disease or complication
* Under treatment of metastatic cancer from other organs or less than 5 years after previous cancer therapy
* Acute liver disease or kidney disease
* Thrombosis or phlebothrombosis requiring treatment, Hyperlipidemia, Smoker