cyrilzakka/clinical-trials huggingface dataset:
Internet Enhanced, Patient-Centered Orthopedic Care: A Prospective, Randomized, Controlled Pilot Trial

The investigators have previously reported on patient utilization of an eRehab patient education web portal that utilizes streaming, clinician prescribed video instruction to motivate and inform patients in self-care of their orthopedic condition, focusing on the importance of a home exercise program. The greatest barrier to patient use of this web-based home exercise treatment plan was the initial access to the program. The purpose of this study is to compare an Internet-based patient education rehab portal (eRehab) to formal physical therapy (PT) in terms of patient costs and outcomes.

This is a prospective, randomized, controlled pilot study. Twenty-four patients who were candidates for a knee or shoulder orthopedic outpatient physical therapy referral were randomized to a 6-week treatment course of either PT or eRehab. Patients were evaluated for outcome scores (KOOS or DASH), pain NRS-11 scores, patient subjective outcomes and cost of treatment.

Eligibility Criteria:
Inclusion Criteria:

* patient diagnosed by board certified orthopedic surgeon to be in need of formal physical therapy referral
* had the ability to access and use the Internet and email
* English-speaking
* non-pregnant adults
* had not received formal physical therapy for their current diagnosis

Exclusion Criteria:

* work-related injuries
* pain NRS-11 score greater than or equal to 6
Sugammadex: Effect on the Awareness Monitoring and Hemodynamics

Sugammadex is used to reverse the neuromuscular blocking effect of steroid neuromuscular blockers. Its cardiovascular effects and effect on brain cortex, if any, may be associated to the reversal of the neuromuscular block. The aim of the study was to investigate the pure effects of sugammadex in the absence of the agonist.

Three groups of patients undergoing elective major surgery and given cis-atracurium for muscle relaxation are studied.

Group 1 receives 2 mg/kg of sugammadex when a count of two of the train of four appears Group 2 receives 4 mg/kg of sugammadex when a posttetanic count 1-3 appears Group 3 receives 16 mg/kg of sugammadex three minutes after administration of cis-atracurium.

Heart rate, arterial blood pressure, oxygen saturation, end-tidal CO2, entropy and bispectral index are recorded every three minutes

Eligibility Criteria:
Inclusion Criteria:

* patients ASA I-III scheduled for elective major surgery
* both sexes

Exclusion Criteria:

* patients hypertensive
* treated with antihypertensive drugs
A Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in ALLO-ASC-CD-101 Clinical Trial

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-CD injection in phase 1 clinical trial (ALLO-ASC-CD-101) for 36 months.

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-CD injection in phase 1 clinical trial (ALLO-ASC-CD-101) for 36 months.

ALLO-ASC-CD is intravenous infusion containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells are directed to injured tissue, and reduce inflammation. Furthermore their immunomodulatory effects are significant for treating immune-related disease, such as crohn's disease. Finally, ALLO-ASC-CD may provide a new option in treating a crohn's disease.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are injected with ALLO-ASC-CD in phase 1 clinical trial of ALLO-ASC-CD-101.
2. Subjects who are able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Subjects who are considered not suitable for the study by the principal investigator.
Effect of Virtual Reality Intervention on Stress Levels of Surgical Nurses

The aim this crossover designed study is to examine the effect of watching a relaxing video with using virtual reality glasses (VR-G) during the break period of a working shift on the stress levels of surgical nurses.

Nurses will be asked to watch a relaxing video with using VR-G for 20 minutes at their break time (the first procedure).

After one-week wash-out period, researchers will compare second procedure (no video watch with VR-G) to see if there is any difference on the stress levels of the nurses.

Allocation of the nurses to the procedure groups (with VR-G and no VR-G procedures) is done with using Random Allocation Software program.

Among the with VR-G procedure:

The nurses were asked to watch a relaxing video with using VR-G for 20 minutes at their break time. The researcher visited the nurses at the beginning of the working shift and asked the nurse stress scale items to them in the nursing room, scheduled a break period with them individually and visited them again at the scheduled time. Then, the researcher prepared the video and googles, asked nurses to sit on the chair in the nursing room at the surgical unit, helped them to wear the VR-G and let them alone to watch the video for 20 minutes.

At the end of their working shift, the researcher visited them and asked the scale items once again.

Among the no VR-G procedure:

The nurses did not watch any video and copleted their routine working shift and break times. The researcher visited the nurses at the beginning and at the end of their working shift and asked the nurse stress scale items to them in the nursing room.

Eligibility Criteria:
Inclusion Criteria:

* working in a surgical unit for at least one year
* able to use virtual reality glasses
* volunteering to participate in this study

Exclusion Criteria:

* having a visual and/or audial problems
* leaving surgical unit for any reason
FlexWave Trial: Efficacy of Extracorporeal Shock Wave Therapy in Post-Stroke Upper Limb Spasticity

Extracorporeal shock wave therapy (ESWT) has emerged as an effective therapeutic intervention for addressing post-stroke limb spasticity. This research aims to explore the therapeutic implications of focused ESWT for wrist and finger flexor muscles in patients suffering from post-stroke upper limb spasticity.

This study aimed to evaluate the effects of focused Extracorporeal Shock Wave Therapy (ESWT) on upper limb flexor spasticity in stroke patients. Participants were randomized into two groups: an experimental group receiving targeted ESWT on specific forearm flexor muscles, and a control group receiving placebo treatments mimicking the shockwave therapy, with treatments administered twice weekly over two weeks for a total of four sessions.

The efficacy of the treatment was measured using a comprehensive set of assessment tools, including range of motion, hand grip strength, pain levels, spasticity scales, functional assessments, as well as measures of daily living activities, ultrasound strain elastography, and electromyography. The outcomes were evaluated at multiple points in time: before treatment, and 1, 4, 12, and 24 weeks after the therapy concluded, to assess both immediate and sustained effects of the treatment on upper limb function and spasticity in stroke survivors.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 years or older with unilateral cerebral stroke.
* Wrist and finger flexor muscle tone with a score greater than 1 on the Modified Ashworth Scale.
* Stable medical condition and vital signs.
* Conscious and able to comply with instructions.

Exclusion Criteria:

* History of more than one stroke, traumatic brain injury, or cerebral neoplasm.
* Coexisting central nervous system disorders (e.g., spinal cord injury, Parkinson's disease) or other musculoskeletal diseases affecting muscle tone assessment.
* Contraindications for shockwave intervention, such as malignancies, coagulopathies, local infections, or use of cardiac pacemakers.
* Undergone shockwave therapy or botulinum toxin injections for post-stroke spasticity in the past three months.
* Cognitive, consciousness, or language impairments preventing participation in the intervention or functional assessments.
Adiponectin, Leptin, h-CRP Values in Obese Children - Important Markers for Metabolic Syndrome?

Obesity is a chronic inflammatory disorder in which leptin, adiponectin and C reactive protein (CRP) play an important role. This study aimed to investigate the relationship between markers of adiposity like leptin, adiponectin and high sensitive C reactive protein (hsCRP) in obese children, and to determine whether these adipokines are significant markers in defining metabolic syndrome in pediatric population

The idea that adipose tissue is just a form of energy storage has changed dramatically in recent years. Currently, adipose tissue is considered to be a true endocrine gland that fulfills multiple roles in regulating different biological functions. Communication between adipose tissue and the rest of the systems is accomplished through bioactive mediators (adipokines) Adipokines control energy homeostasis and are involved in metabolic, endocrine and immunological processes.This study aimed to investigate the relationship between markers of adiposity like leptin, adiponectin and high sensitive C reactive protein (hsCRP) in obese children, and to determine whether these adipokines are significant markers in defining metabolic syndrome in pediatric population.The current retrospective observational study was conducted at the "Louis Turcanu" Emergency Hospital Timisoara over a period of one year, from July 2013 and June 2014. All inborn patient files were analyzed as anonymised limited data sets from archived records of the Endocrinology, Diabetology and Cardiology department.

Eligibility Criteria:
Inclusion Criteria:

* obese children (BMI\> 95th percentile)

Exclusion Criteria:

* obesity caused by endocrine disease, syndromic obesity, systemic disease or acute illness.
Prolonged Treatment for Infected Abortion After Hospital Discharge.

Patients with infected abortion will be treated with dilatation and curettage, intravenous antibiotics. The purpose of this study is to verify if it is necessary to keep the use of oral antibiotics after hospital discharge.

The use of 7-10 days of treatment for infected/septic abortion is not based on clinical trials. A recent evidence showed that endometritis post cesarean section needs no treatment after hospital discharge. The objective of this study is to verify if this finding also applies to infected abortions.

After in hospital treatment, the patients will be randomized to the traditional treatment (metronidazole and doxycycline) or to placebo until 10 days of treatment is completed. Active follow-up will be done every 2 days, and the patient will be reevaluated at the end of treatment.

Cure will be defined as the absence of fever, pain and bleeding. Failure of treatment will be considered as the need for hospitalization or additional antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* History of intrauterine manipulation with contaminated objects.
* Vaginal secretion with fetid odor
* Presence of pus flowing through the cervical uterine
* Presence of peritonitis
* Leucocytosis (\> 14,000 leucocytes/mL)
* Vasodilatation, bounding pulse and paradoxically warm periphery with tachycardia (Heart rate\> 110 bpm)
* Cyanosis and/or paleness
* tachypnea(\> 30mpm)
* Arterial hypotension (SAP\< 90mmHg)
* Oliguria
* Fever (\> or = than 37,8°C)

Exclusion Criteria:

* Refusal to participate in the project
* Prior use of antibiotics within one week
* Known allergy to Doxycycline or Metronidazole
* Presence of tubo-ovarian abscess
An Open-Label Extension Study to Evaluate the Safety and Effectiveness of RWJ 333369 in Patients With Epilepsy

The purpose of this study is to evaluate the safety and preliminary effectiveness of the novel compound RWJ-333369 in patients with partial onset seizures who are currently being treated with 1 or 2 concomitant antiepileptic drugs.

333369EPY2002 is the open-label extension study that follows the double-blind study 333369EPY2001. In an open label study such as 333369EPY2002, both the physician and the patient know the name of the assigned study medication. In a double blind study such as 333369EPY2001, neither the physician nor the patient knows the name of the assigned study medication. Patients who complete the double-blind treatment phase of study 333369EPY2001 will be eligible to enter the open-label extension study during which patients will transition through a blinded period to an open-label period with carisbamate (also referred to as RWJ-333369). RWJ-333369 is a new chemical compound with anticonvulsant activity that is currently under investigation as a treatment for epilepsy. Patients electing to enter the open-label extension phase will be supplied with both open-label carisbamate (RWJ-333369) and blinded study medication for the transition phase. During this transition phase (up to 21 days in length), the patient's dose of double-blind study drug will be gradually reduced and stopped and treatment with open-label RWJ-333369 will be started. Throughout the remainder of the open label extension phase, investigators will be allowed to make further adjustments of the dosage and schedule of carisbamate, including independent adjustment of the morning and evening doses, but a dosage of 1,200 mg/day may not be exceeded and increases in dosage must be in increments of no more than 200 mg/day. Patients who, in the judgment of the investigator, continue to benefit from treatment with RWJ-333369 may continue to receive the drug with follow up clinic visits every 3 months until RWJ 333369 is available by prescription or the program is terminated by the sponsor. Initial dose RWJ-333369 is 1 capsule (250 milligram (mg) taken twice daily. Dosage may be changed at weekly intervals. The maximum permitted dose will be 4 capsules (1000 mg), twice daily during dose titration. Double blind-treatment duration is up to 71 days with the option to continue treatment in an open-label study. Maximum dose in open-label study is 1200 mg/day

Eligibility Criteria:
Inclusion Criteria:

* In order to enter the open label extension, the patient must have completed Study 333369EPY-2001.

Exclusion Criteria:

* Patients who have seizures that cannot be quantitated accurately
* patients with a history of nonepileptic seizures, serious systemic disease, progressive neurologic disorder, a major psychiatric disorder, status epilepticus in the past 3 months, vagal nerve stimulation discontinuation within the past 3 months
* patients with a history of drug or alcohol abuse within the past 2 years
* patients currently taking felbamate, vigabatrin, or tricyclic antidepressants
* and female patients who are pregnant or nursing.
Colchicine in Coronary Artery Bypass Graft (CABG)

There is evidence that inflammatory processes may play a key role during surgical myocardial reperfusion. The hypothesis of this study is that colchicine, an anti-inflammatory agent, may lead to reduction in periprocedural infarct size, when administered during elective coronary artery bypass graft surgery.


Eligibility Criteria:
Inclusion Criteria:

* The study will enroll patients 18 years old or older who are eligible to undergo CABG surgery.

Exclusion Criteria:

Excluded are patients:

* with age \> 80 years old
* scheduled for concomitant valve surgery
* scheduled for coronary surgery without cardiopulmonary bypass
* with peripheral vascular disease aﬀecting the upper limbs
* with acute coronary syndrome within the previous 4 weeks
* on inotropic or mechanical circulatory support before induction of anaesthesia
* with any disorder that could potentially increase preoperative cTnI concentrations (eg, percutaneous coronary intervention within the previous 6 weeks)
* with active inflammatory diseases, infectious diseases or known malignancy
* under treatment with corticosteroids, anti-inflammatory agents or disease modifying agents
* with known hypersensitivity-allergy to colchicine
* under chronic treatment with colchicine
* with severe renal failure (eGFR \< 35 ml/min/1.73 m2)
* with hepatic failure (Child - Pugh class B or C)
A Randomised, Assessor-Blind, Comparative Efficacy Clinical Trial of 3 Pediculicides.

Objective

To compare the cure rates (defined as the complete absence of live lice, adults or nymphs, as diagnosed by wet-combing of three Australian approved head lice products for the treatment of primary school children with head lice infestation. The study design will be randomised and assessor-blind using three comparative parallel treatment groups.

The study population will consist of Queensland state primary school children (up to Year 7) with live head lice (adults or nymphs) on the hair or scalp who have not used any head lice product in the four weeks prior to the study.

All products were used according to the manufacturer's instructions. KP24 and Banlice were applied twice separated by a one week interval. MOOV Head Lice Treatment was applied on Day 0, Day 7 and Day 14. The cure rate (absence of live lice) one day after the first administration for all products was a secondary outcome measure. The cure rate at 7 days after the final administration (Day 14 for Banlice or KP24 and at Day 21 for MOOV Head Lice Treatment) was the primary outcome measure. Siblings were treated if these were found to be infected as an enrolment criteria.

Eligibility Criteria:
Inclusion Criteria:

* Male or female primary school children.
* Presence of live head lice (adults or nymphs) on the hair or scalp. The presence of live lice will be determined from a visual inspection of the hair and scalp and Dry-combing of the hair. Combing will stop immediately once live lice are observed. The presence of lice eggs alone is not a sufficient condition for inclusion in the trial.
* Be available for the duration of the trial.
* Parent / Guardian is willing not to use other head lice products or methods (e.g. combs) to treat their child's head lice for 21 days after the first treatment.
* Parent / Guardian has given written informed consent to their child's participation in the trial.

Exclusion Criteria:

* History of allergies or adverse reactions to head lice products or the components of the specific products being tested.
* Treatment with any head lice product in the month prior to Day 0.
* Presence of scalp disease(s).
* If a subject has a sibling in Grade 1-7 this sibling must also be enrolled in the study and treated on Day 0 otherwise the subject must be considered ineligible for enrolment.
* Subjects must have one fixed place of residence
Neurotherapy to Promote Emotion Recognition in Autism

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder, more prevalent than previously thought and heterogeneous in expression, though uniformly characterized by severe social disability. The social disability that defines ASD pervades other areas of adaptive behavior, is predictive of secondary mental health problems, and adversely affects long-term outcome. Although ASD is a chronic condition, there has been little research on interventions for adults with ASD. This study proposes to first establish the neural plasticity of specific brain mechanisms underlying difficulties with facial emotion recognition, a core deficit believed to be pivotal in the behavioral expression of ASD-social disability. The investigators will then develop a novel, computer-based intervention using real-time feedback, to the user, to ameliorate emotion recognition deficits.

Individuals with autism spectrum disorder (ASD) are known to have difficulty in the recognition of facial emotion. Such deficits in facial emotion recognition (FER) are thought to cause or exacerbate social disability in ASD by preventing 1) accurate detection of social/emotional information conveyed through the face and, subsequently 2) the deployment of emotionally appropriate responses. Consistent with this model, FER deficits are correlated with social disability in ASD and confer morbidity above and beyond core symptoms.

The long-term goal is to understand how FER networks can be manipulated for therapeutic and preventative purposes. In this trial, investigators are testing the feasibility of an intervention that capitalizes on our previously developed brain-computer interface (BCI) to promote FER in a mixed virtual reality world. The new "FER Assistant" tool (deployed on a tablet - iPad) is intended to aid users in detecting emotions and intents of 'avatars' inhabiting a virtual world, and will provide users with a highly realistic testbed for practicing FER skills in concert with BCI.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of ASD

Exclusion Criteria:

* No severe psychopathology which warrants other immediate treatment
To Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

This is a 12-week chronic-dosing study to assess the efficacy and safety of BGF MDI compared to BFF MDI in subjects with moderate to very severe COPD.

This is a multicenter, randomized, double-blind, parallel-group, 12-week chronic-dosing study to assess the efficacy and safety of BGF MDI compared to BFF MDI in subjects with moderate to very severe COPD. The study has a total of 7 visits over a Screening Period of up to 28 days and a Treatment Period of 12 weeks followed by a telephone follow-up call 14 days after the last dose of study drug.

Eligibility Criteria:
Key Inclusion Criteria:

* Signed Informed Consent
* Subjects with an established clinical history of COPD
* Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be \<0.70 and FEV1 must be \<80% predicted normal value
* All subjects must have been on 2 or more inhaled maintenance therapies for the management of their COPD for at least 6 weeks prior to Screening
* Current or former smokers with a history of at least 10 pack-years of cigarette smoking
* Women of Non-childbearing potential
* Women of childbearing potential and sexually active agree to prevent pregnancy by using acceptable contraceptive methods consistently

Key Exclusion Criteria:

* Significant diseases or conditions other than COPD, which in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study
* Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception
* Current diagnosis of asthma
* Uncontrolled sleep apnea
* Other Serious Respiratory Disorders
* Hospitalized due to poorly controlled COPD within 6 weeks
* Poorly Controlled COPD
* Immune deficiency and/or severe neurological disorders affecting control of the upper airway
* Hypersensitivity to β2-agonists, corticosteroids, or muscarinic anticholinergics
Effect of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Infants in China

The purpose of this study is to determine the effect of infant formula with high percentage of palmitic acid at the sn-2 position (InFat™) on improving fat absorption and general gastrointestinal tolerance in Chinese formula-fed term infants.

The purpose of this study is to assess the efficacy of infant formula with high percentage of palmitic acid at the sn-2 position (InFat™) as compared to standard vegetable oil based infant formula on general gastrointestinal tolerance and fat absorption, reducing calcium soaps formation and stool hardness in Chinese formula-fed term infants.

Eligibility Criteria:
Inclusion Criteria:

* Parental/legal guardian written informed consent;
* The mother had unequivocally decided not to breast-feed (for formula fed infants) or to breastfeed (for human milk fed infants).
* Term infant of Chinese origin born at 37-42 gestation weeks
* Birth weight appropriate for gestational age (AGA), 2500-4000grams
* The infant is apparently healthy at birth and entry of study.

Exclusion Criteria:

* Adverse maternal, fetal or infant medical history that can potentially affect efficacy parameters, tolerance, growth and/or development
* The infant is not a singleton newborn