cyrilzakka/clinical-trials huggingface dataset:
Television Viewing (TVV) & Puberty on Lunchtime Food Intake

The investigators hypothesize that television viewing will affect food intake in adolescent girls, and will depend on pubertal stage. Food intake will be measured at 30 min following a glucose(1 g of glucose/kg body weight) or sweetened noncaloric beverage with or without the presence of TV. Subjective appetite will be measured as well.


Eligibility Criteria:
Inclusion Criteria:

* healthy girls with no emotional, behavioral or learning problems

Exclusion Criteria:

* boys
Open-label Extension Study Of RN624

Study RN624-CL007 is planned to be an open-label protocol to enroll subjects who have previously participated in Study No. RN624-CL006. In this study, subjects will receive RN624 on an open-label basis.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in Study RN624-CL006

Exclusion Criteria:

* The occurrence of any adverse event or condition during the controlled studies that, in the opinion of the Investigator, should exclude the subject from participating in the open-label extension
* Pregnant or lactating female subjects or subjects who do not agree to use an appropriate form of birth control throughout the study and for 3 months after completing the study
Photodynamic Therapy and Topical Antifungal for Onychomycosis in Patients With Diabetes.

There are different therapeutic alternatives for onychomycosis. Systemic therapy is widely used due to its easy accessibility, low cost and high efficacy, but may be associated with systemic adverse events and drug-drug interactions, so its use in patients with diabetes, immunocompromised and frequently take more than five drugs is not recommended even though these individuals are at serious risk of fungal infection. On the other hand, laser therapy would be contraindicated in patients with neuropathy or peripheral vascular disease (diabetic foot patients) because of possible burns. Topical antifungals or lacquers are associated with a low risk of systemic adverse events and drug-drug interactions and would therefore be the most appropriate treatment for patients with diabetic foot. However, they require very long treatment periods, are generally applied daily for 12 months to allow the normal nail to grow and replace the regions damaged by the infection and have a lower cure rate.

Because of all the above difficulties, there is a need to augment topical treatments in routine clinical practice with adjunctive therapies such as photodynamic therapy for the treatment of onychomycosis in patients with diabetes.

The main aim of this study is to observe the effectiveness and safety of the combination of photodynamic therapy with the usual antifungal treatment in consultation in patients with diabetes. Secondary aims have been defined as follows:

To determine whether 3 sessions of photodynamic therapy combined with topical therapy, over a period of 6 months, is sufficient to achieve clinical, mycological and complete cure of onychomycosis; And to analyse the influence of the type of onychomycosis (ODL, total dystrophic, superficial), the causal fungal agent (dermatophyte, mould or yeast) and the degree of severity of onychomycosis (through the OSI) on the response to treatment.

Patients included in the study will be visited every 2 weeks during the first two months, applying photodynamic therapy during visits 2, 3 and 4. Subsequently, a check-up will be performed two weeks after the last application of photodynamic therapy and monthly visits for the remainder of the study. At each visit and at subsequent check-ups, the nail plate and peri- and subungual hyperkeratotic tissue will be debrided and reamed in order to improve the effects of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes diagnosed with toenail onychomycosis with positive microbiological culture/PCR.

Patients over 18 years of age.

Exclusion Criteria:

* Patients who have received topical or systemic antifungal treatment in the previous month.
3D Team Care for Cognitively Vulnerable Older Adults

This study addresses how to achieve better outcomes for cognitively vulnerable community-dwelling older adults and their families. Cognitive vulnerability means living with dementia, depression, and/or a recent episode of delirium (the 3Ds). The investigators will test the effectiveness of a team care model focused on the 3Ds (Home Based Care Team) guided by nurse practitioners with expertise in geriatrics and geriatric psychiatry. Specific aims are to determine Home Based Care Team effects on hospitalization or emergency department use, and other outcomes including depression, disability, and quality of life.

This study addresses how to achieve better outcomes for cognitively vulnerable community-dwelling older adults and their families. Cognitive vulnerability means living with dementia, depression, and/or a recent episode of delirium (the 3Ds). Cognitive vulnerability in older adults is often overlooked by primary care and hospital-based providers, and represents a marker for overall vulnerability or frailty often missed when disease-specific approaches are emphasized in the care for older adults. Such patients often cannot adequately self-manage their comorbidities. Many studies of older adults and their families have demonstrated the great burden of living with cognitive vulnerability. The investigators will test the effectiveness of a team care model focused on the 3Ds (Home Based Care Team) guided by nurse practitioners with geriatrics expertise. Other team member disciplines will include pharmacy, social work, occupational and physical therapy, nutrition, and community health worker. Long-term objectives are to determine whether this care model can become a widely available approach for improving healthcare systems for older adults with cognitive vulnerability and their families, while improving outcomes of importance to these patients and families. A project Steering Committee, including cognitively vulnerable patients and family caregivers, will provide extensive input into many aspects of the research process.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of dementia, depression, and/or delirium, based on diagnostic codes found in medical claims data and based on screening at time of study screening.
* Living in the community, including assisted living facility, at time of randomization
* Plan to live in geographic area for 12 months
* Speak or understand English
* Willing to be randomly assigned to intervention or active comparator group

Exclusion Criteria:

* Diagnosed schizophrenia or bipolar disorder
* Bedbound and non-communicative
* Life expectancy \<12 months
* Already enrolled in active comparator program
* For individuals with dementia, family caregiver is unavailable or unwilling to enroll in study
The Effect of Panax Notoginseng Powders on Rheumatic Pain

The purpose of this study is to evaluate the effect of Panax Notoginseng Powders on Rheumatic Pain.


Eligibility Criteria:
Inclusion Criteria:

* had a diagnosis of classic or definite RA
* without conflict to the written, informed consent signed prior to the enrollment.

Exclusion Criteria:

* uncontrolled medical problems
* organic brain syndrome
* major psychiatric disturbances
* major communicative disorders
* a history of severe noncompliance
* less than 7 years of formal education, or illiteracy
* being included in other clinical trial within the last 4 weeks
* with abnormal liver or kidney function (more than 1 time above the high normal)
* with serious cardiovascular disease
* with hematologic disease
* being in pregnancy, lactation period or under a pregnancy plan
* with severe gastrointestinal disease
* with contraindication or being allergic to the test drugs
* being under the treatment of drugs within 1 previous week, that might affect the results of the trial, such as non-steroidal anti-inflammatory drugs
* being not compatible for the trial medication, or other circumstances at the discretion of investigators
* without legal capacity or only with limited legal capacity
Molecular Characterization of Gliomas Using a Broad Next Generation Sequencing (NGS)Panel

Gliomas are the most common malignant primary brain tumors with poor prognosis. The genotyping of tumors using NGS platforms enables the identification of genetic alterations that constitute diagnostic, prognostic and predictive biomarkers.Here in, we investigated the molecular profile of 32 tumor samples from 32 patients with high grade gliomas by implementing a broad 80-gene targeted NGS panel while reporting their clinicopathological characteristics and outcomes.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of high grade glioma based on tissue biopsy

Exclusion Criteria:
Topical Ibuprofen for Delayed Onset Mulscle Soreness

The objective of this study is to compare the efficacy and safety of Ibuprofen 5% Topical Gel versus placebo administered two or three times daily for the treatment of pain associated with delayed onset muscle soreness following intense eccentric exercise of the elbow flexor muscles.


Eligibility Criteria:
Inclusion Criteria:

Males or females, 18 to 65 years of age, who have not engaged in upper extremity fitness activities for a minimum of 3 months prior to entry in the study; subjects must be willing to refrain from use of pharmacologic or non pharmacologic treatments (ie, heat, ice, massage) and other forms of soreness relief during the study

Exclusion Criteria:

Use of corticosteroids or short- or long-acting non-steroidal anti-inflammatory drugs
Impact of Swallowing Impairment on Individuals With Parkinson Disease

In this online study, investigators will explore the psychosocial burdens of swallowing difficulties in people with Parkinson's Disease. This study is completely virtual, so you can participate from wherever you live in the United States. Participation requires you to complete a one-hour Zoom interview and a brief questionnaire. You will be compensated with a $25 Walmart gift card. To learn more, please use the "send email" feature. Thank you!

This is a mixed methods study. The investigators will collect qualitative data from participants by conducting 1-2 hour semi-structured interviews on Zoom. The interview questions are designed to systemically inquire about patient experiences, affective reactions, coping strategies, social support, self-identity issues, and treatment experiences. The investigators will collect quantitative data by asking participants to complete The Brief Illness Perception Questionnaire. The data will be analyzed using a comprehensive stress and coping model, which has not been done previously in the field. The investigators hope to discover themes about psychosocial burdens and related coping mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* Participants must currently have oropharyngeal dysphagia and Parkinson Disease
* Participants must be at least 18 years of age
* Participants must speak English.

Exclusion Criteria:

* Participants whose receptive and expressive language skills will not allow them to participate in one-on-one interviews
Electromyographic´s Differences Between Dry Needling in Tonic or Phasic Skeletal Muscle Fibers.

The aim of this study is to compare the surface electromyography (EGM) changes between dry needling in the upper trapezius, is a prevalence tonic fiber or lower trapezius is a prevalence phasic fiber.

Several studies already found a disturbed surface electromyography activity in myalgic muscle tissue and in the vicinity of myofascial trigger points, however studies about the effect of dry needling in this fibers type on these disturbances in EMG activity are scarce.

The surface electromyography of upper trapezius is related with a tonic muscle dysfunction, for example muscle contracture; and the lower fiber of trapezius is related with atrophy muscle.

Dry needling is an effective method for the treatment of myofascial trigger points for immediate reduction of pain. There are some studies about latent myofascial trigger point and motor activity, but we don't know any research about the effect of dry needling in the differences fibers.

Eligibility Criteria:
Inclusion Criteria:

* Presence latent myofascial trigger point in the upper/lower trapezius asymptomatic subjects

Exclusion Criteria:

* neck or shoulder pain at the moment or 6 month ago. whiplash injury previous spine or shoulder surgery pregnancy diagnosis of radiculopathy or myelopathy
Bridge Occlusion Balloon in Lead Extraction Procedure

To evaluate the use of an occlusion balloon (Bridge™ Occlusion Balloon, Spectranetics) within the Superior Vena Cava in lead extraction patients.

This study will evaluate the use of an occlusion balloon (Bridge™ Occlusion Balloon, Spectranetics) within the Superior Vena Cava in lead extraction patients. This will be performed in a non-emergent setting to allow for evaluation of how best to integrate this new technology into the investigators clinical practice. The study will focus on the effect of the Bridge balloon on the patient preparation clinical workflow, ease of insertion/positioning/deployment, and the ability to recognize proper inflation and vein sealing under fluoroscopy. Understanding these factors will help build a more robust clinical workflow with the goal of better patient outcomes in the case of an Superior Vena Cava injury. The images and data generated during this study can help in dissemination of the practical use knowledge to fellow lead extractors.

At the time of the protocol registration, the timeframe 12 months was entered, this was actually the anticipated length of the study at registration. The timeframe was corrected to 33 minutes (average time) at the time of results entry.

Eligibility Criteria:
Inclusion Criteria:

* Subject age more than 18 years
* Lead extraction patients

Exclusion Criteria:

Lead extraction patients with:

* Superior Vena Cava occlusion or stenosis.
* Significant vegetation.
* Hemodynamic instability.
* Class IV heart failure
* Creatinine \> 2.0mg/dL
* Patients \> 85 years old
High Dose of Vitamin C on Mechanically Ventilated Septic Patients in Intensive Care Unit

Prospective, Randomized clinical trial study will be carried out in intensive care unit in Ain Shams University Hospitals on 40 forty septic patients admitted to ICU and mechanically ventilated.

This study will be carried out in intensive care unit in Ain Shams University Hospitals , Cairo,Egypt on 40 patients admitted to ICU that are septic patients and mechanically ventilated which will be recruited into the study . After approval from ethical committee, an informed consent will be obtained from relatives of all patients. All data of patients will be confidential with secret codes and private file for each patient. Each patient's relative will receive an explanation for the purpose of the study. The study design will be prospective , randomized clinical trial.

Methodology:

All patients will be subjected to:

1. Complete history taking.
2. Full clinical examination
3. Evaluation and monitoring of(pulse oximetry , ECG, NIBP, temperature)
4. CBC , Blood gas (for determination of (PaO2/FiO2), Blood cultures,serum Creatinine and total bilirubin were recorded daily for the first 7 days.
5. Severity scores by calculating Acute physiology and chronic health evaluation (APACHE II)score

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Age from age≥18 years
* Septic patient admitted to ICU and mechanically ventilated diagnosed by sepsis criteria proposed by the American College of Chest Physicians/Society of Critical Care Medicine
* Expected to survive and remain in the ICU for at least 96 hours after study entry

Exclusion Criteria:

* Age\<18 years
* Pregnant females
* Patients with history of aspiration before intubation
* Respiratory distress syndrome
* Ischemic reperfusion injury
* Cancer as the cause of SIRS or sepsis
* Chronic kidney diseases
* Ongoing shock
* Allergy from interventional drug on the study
An Open-label Extension Trial to Investigate Possible Drug-drug Interactions Between Stiripentol or Valproate and Cannabidiol in Patients With Epilepsy

This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive the same dose of GWP42003-P. However, investigators may subsequently decrease or increase the participant's dose until the optimal dose is found.


Eligibility Criteria:
Note: Participants who enroll in France or Sweden must be aged 18-55 years.

Key Inclusion Criteria:

* Participant must have a documented magnetic resonance imaging/computerized tomography of the brain that ruled out a progressive neurologic condition.

Key Exclusion Criteria:

* Participant has clinically significant unstable medical conditions other than epilepsy.
* Participant has a history of symptoms related to a drop in blood pressure due to postural changes (e.g., dizziness, light-headedness, blurred vision, palpitations, weakness, syncope).
* Participant has any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the C-SSRS in the last month.
* Participant is currently using felbamate and has been taking it for less than 12 months prior to screening visit of the blinded phase of the trial.
* Participant is currently using or has in the past used recreational or medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex®) within the 3 months prior to trial entry.
* Participant has any known or suspected history of any drug abuse or addiction.
* Participant is unwilling to abstain from recreational or medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex) for the duration for the trial.
* Participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the Investigational Medicinal Product (IMP), e.g., sesame oil.
Cidofovir as a Treatment for Herpes Simplex in Patients With AIDS

The purpose of this study is to see if cidofovir gel (Forvade) is safe and effective in treating herpes simplex in patients with AIDS who do not respond to acyclovir.

Patients receive open-label treatment with cidofovir gel.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* AIDS diagnosis per CDC criteria.
* At least partially external mucocutaneous HSV infection confirmed by culture of current outbreak.
* Current HSV outbreak that is unresponsive to \>= 10-day course of acyclovir at 1-4 gm/day po or 15 mg/kg/day IV or in vitro resistance of HSV isolate to acyclovir demonstrated within 60 days of study.
* Signed, informed consent from parent or legal guardian for patients less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

Evidence of cervical intraepithelial neoplasia class III (CIN III) on Pap smear (Pap smear required within 6 months of starting study drug).

Concurrent Medication:

Excluded:

Acyclovir, valacyclovir, famciclovir, ganciclovir, foscarnet, topical trifluride, cidofovir injection or other systemic or topical drugs with anti-herpes activity.

Required:

\>= 10 day course acyclovir at 1-4 gm/day po or 15mg/kg/day IV (not required if there is confirmed in vitro resistance to acyclovir).
Intensive Physiotherapy in Children Affected by Posterior Fossa Tumors

The objective of the current study is to describe the effectiveness of conventional and intensive physiotherapeutic intervention in improving gross motor skills (i.e. postural changes, walking and balance skills) in children affected by posterior fossa tumors

The surgery aimed to remove tumors located in the cranial posterior fossa can lead, as a consequence, to a clinical condition of ataxia.

Children affected by this condition are commonly referred to physiotherapy treatment, even though the level of scientific evidence in the field of motor rehabilitation is still lacking.

The objective of the current study is to describe the effectiveness of conventional and intensive physiotherapeutic intervention in improving gross motor skills (i.e. postural changes, walking and balance skills) in children affected by posterior fossa tumors.

By conventional physiotherapy intervention we mean a therapeutic path with a 1:1 operator-patient ratio and which does not make use of robotic or virtual reality devices.

By intensive we mean that it occurs twice a day, 5 days a week, for a duration of four weeks.

Given the high variability in the severity of the clinical pictures, the primary objective will be the patient's improvement in gross motor skills as a whole, which will be identified with the Gross Motor Function Measurment (GMFM) scale.

Changes will also be monitored with respect to the autonomy and assistive care in the daily life of the recruited patients (scored through WeeFIM or FIM), the risk of fall (scored through the Pediatric Balance Scale) and with a sign-specific scale on ataxia (Scale for Assessment and Rating of Ataxia) Finally, for walking patients, walking resistance will be assessed through the 6 minute walking test (6MWT)

Eligibility Criteria:
Inclusion Criteria:

* subjects who underwent to surgical resection of tumors located in posterior fossa, age between 0 and 25 years

Exclusion Criteria:

* Subjects that are currently addressed to rehabilitative protocols availing of technological devices
Action Plan to Enhance Self-management and Early Detection of Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients

The purpose of this randomized controlled trial is to evaluate the hypothesis that the 'written' action plan, a self-management tool developed by the project group, enhances early detection and prompt action measures and consequently isbeneficial in exacerbation outcome (i.e., health status recovery time).

Early detection of exacerbations by COPD patients initiating prompt interventions has shown to be clinically relevant. Until now, research failed to identify the effectiveness of a written individualized Action Plan (AP) to achieve this. The current multicenter, single-blind RCT with a follow-up period of 6 months, evaluates the hypothesis that individualized AP's reduce exacerbation recovery time. Patients are included from regular respiratory nurse visits and allocated to either usual care or an additional AP providing individualized treatment prescriptions (pharmaceutical and non-pharmaceutical) related to a colour coded symptom status (reinforcement at 1 and 4 months). Although usually not possible in self-management trials, we ensured blinding of patients, using a modified informed consent procedure in which patients give consent to postponed information. Exacerbations in both study arms are defined using the Anthonisen symptom diary-card algorithm. The Clinical COPD Questionnaire (CCQ) is assessed every 3-days. CCQ-recovery time of an exacerbation is our primary outcome. Additionally, healthcare utilisation, anxiety, depression, treatment delay, and self-efficacy are assessed at baseline, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio \< 70%
* age \> 40 years
* complaints of chronic cough
* smoking history of more than 20 years or 15 pack-years
* diagnosis of COPD as major functionally limiting disease and
* current use of bronchodilator therapy.

Exclusion Criteria:

* primary diagnosis of asthma
* primary diagnosis of cardiac disease
* presence of disease that could either effect mortality or participation in the study (e.g. confusional states).