cyrilzakka/clinical-trials huggingface dataset:
Effect of Kinesio-taping of Lower Limbs

The goal of this clinical trail is to test if kinesio-taping on lower limbs has an effect on balance and gait in children with diplegic cerebral palsy. Children in study group will have designed physiotherapy for gait and balance, the control group will have designed physiotherapy in addition to kinesio-taping on both lower limbs.

Diplegic cerebral palsy is the most prevalent type of cerebral palsy. The main challenge for spastic cerebral palsy is gross motor dysfunction. The motor problems of spastic cerebral palsy arise fundamentally from central nervous system dysfunction, which interferes in the development of normal alignment postural control against gravity and impedes normal motor development.

Positive effects of kinesio taping for improving range of motion in patients with different disorders are reported in some of the studies. In the present study, kinesio taping along with physiotherapy treatment is considered an effective method for postural control improvement in diplegic cerebral palsy children.

Given the importance of motion and functional mobility in daily life, design and execution of accurate scientific interventions is necessary for health care systems economically and ethically.

Research on this field and accurate analysis of functional mobility, spasticity, and range of motion are rare. The main goal of physical therapy in the rehabilitation of cerebral palsy is to improve motor function and increase the ability to control movement. therefore, the present study aims to explore the effects of kinesio taping of lower limbs on gait and balance of children with spastic diplegic cerebral palsy.

Eligibility Criteria:
Inclusion Criteria:

1. A medical diagnosis of spastic diplegic cerebral palsy made by pediatricians or pediatric neurologists.
2. Children with spasticity grades ranged from 1 to 1 plus according to Modified ashworth scale.
3. Their age range from 6 to 10 years.
4. Children who can stand with poor balance and recognize and follow verbal orders and commands included in both testing and training techniques
5. No orthopedic surgeries

Exclusion Criteria:

1. Children who have skin sensitivity for using kinesio-taping.
2. A history of cardiac or orthopedic disability.
3. Children having visual or auditory defects.
4. They had a permanent deformity.
Clinical Study of Effectiveness of Radiotherapy Before Surgery in High-risk Relapse Hepatocellular Cancer Patients

This study aims to evaluate the effectiveness of radiotherapy before surgery in high-risk relapse hepatocellular cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of HCC
2. In high risk of recurrence of HCC but still can endure palliative resection
3. KPS scores are \>90
4. With Child-Pugh Class A liver funcion, serum bilirubin\< 1.5\*normal maxism; ALT and AST\< 1.5\*normal maxism; normal creatinine and urea nitrogen; WBC\>4×109/L, Hb\>110g/L, PLT\>90X109/L.
5. Have signed informed consent

Exclusion Criteria:

1. HCC cannot be operated
2. With Child-Pugh Class B/C
3. Have other organ cancer, excluding curative non-melanotic skin cancer and carcinoma in situ of cervix
4. Have other severe disease
5. With active hepatitis
6. Have accepted local radiation therapy in other hospitals
7. KPS scores≤70
8. Tumor edges cannot be defined
9. Have severe cirrhosis complication
10. Intensity modulated radiation therapy cannot reach required dose
11. Cannot cooperate
12. Lactant or pregnant
13. Cannnot be informed
Complementary Therapies for the Reduction of Side Effects During Chemotherapy for Breast Cancer

The purpose of this study is to determine wether a complementary therapy consisting of a combined medication of selenium, milk thistle, goldenrod and bromelain and a consultation concerning nutrition and physical activity can reduce side effects of a chemotherapy in breast cancer patients.

patients were randomized to receive: (a) individual nutrition consultation with recommendations for physical activity before or on the first day of chemotherapy together with daily oral medication consisting of selenium (sodium-selenit 100 microg/d), milk thistle (silibin 280 mg/d), goldenrod (solidago 1,680g/d) and pineapple enzyme (bromelaine 3.000 F.I.P. units/d) during the first three cycles till 3-5 weeks later, (b) individual nutrition consultation with recommendations for physical activity only and (c) a leaflet "5-a-day" for the control group.

Primary endpoint was the difference of the global health status from the EORTC QLQ-C30 before and 3-5 weeks after the third cycle of chemotherapy. Secondary endpoints were the other subscales of the EORTC QLQ C3o and BR 23 and anxiety and depression from the HADS-D.

Eligibility Criteria:
Inclusion Criteria:

* Indication for chemotherapy for breast cancer for at least 3 cycles

Exclusion Criteria:

* Prior chemotherapy within 12 months
* use of herbal or nutritional supplements or other complementary or alternative medications ≥ 7 days prior to start of chemotherapy and during the trial
* allergy to study medication
* Selenium intoxication
* Current use of cumarins or other medication influencing the coagulation system
* Edema in case of impaired cardial or renal function
* Other severe medical condition
* Psychiatric or central neurological disorders
* Regular fluid intake \< 2000 ml per day
An Observational Study of Peginterferon Alfa-2a Plus Ribavirin for Hepatitis C Virus (HCV) Infection in Austria

This noninterventional, open-label study will observe the safety and tolerability of peginterferon alfa-2a in combination with ribavirin among Austrian participants treated for HCV infection according to routine practice.


Eligibility Criteria:
Inclusion Criteria:

* Ongoing treatment with peginterferon alfa-2a and ribavirin at the discretion of the prescribing physician
* HCV infection

Exclusion Criteria:

* None specified
Atezolizumab and Bevacizumab With Combined Radiotherapy for Advanced Hepatocellular Carcinoma

Atezolizumab plus Bevacizumab combination therapy (AtezoBev) is well-known 1st-line therapy for advanced hepatocellular carcinoma (HCC). However, there are unmet needs for patients with advanced HCC who do not respond to AtezoBev. External beam radiotherapy (RT) is another well-known locoregional therapy for HCC that induces inflammatory cascade and abscopal effect as a systemic anticancer effect and enhances the effect of AtezoBev. Therefore, the investigators aim to verify the effect of AtezoBev plus RT for advanced HCC through this single-center, prospective phase II one-armed cohort study over three years. This study recruits 51 patients to verify the effect of the intervention. Atezolizumab (1200mg) and Bevacizumab (15mg/kg) are administered to patients once for each cycle at 3-week intervals, and additional radiotherapy for the mass or portal vein tumor thrombosis is performed before second cycle of AtezoBev. The primary endpoint is progression-free survival by using response evaluation with modified RECIST.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥19;
2. clinically or histologically diagnosed HCC;
3. HCC with Vp2-Vp4 portal vein invasion;
4. intact liver function with Child-Pugh class A;
5. adequate size of RT field;
6. intact performance with ECOG below 2;
7. non-pregnant with acceptable contraception in premenopausal women);
8. without other life-threatening diseases;
9. ability to provide written informed consent and to comply with all study conditions.

Exclusion Criteria:

1. Active uncontrolled infection;
2. Current or history (\< or = 5 years) of advanced malignancies in the other organs;
3. History of liver transplantation;
4. miliary HCC which incompatible external beam RT
Structure and Function of the Gastro-esophageal Junction

Aims of research project:

To identify key features of the gastro-esophageal junction (structure and function) that protects the esophagus from gastro-esophageal reflux investigated by combined high resolution manometry and magnetic resonance imaging.

Hypothesis:

1. Functional factors including GEJ function (e.g. sphincter pressure) and proximal gastric distension determine whether or not TLESR occurs; however
2. Structural factors including separation of GEJ anatomy, intra-gastric distribution of the meal and secretions determine whether TLESR is accompanied by no reflux event, gas reflux (belching) or reflux of ingested food and gastric secretion ('true reflux').
3. Initial findings by descriptive studies in healthy volunteers (study #1) and patients with mild to moderate gastro-esophageal reflux disease (study #2) will be further interrogated by a randomized, double-blind control trial of baclofen in patients with GORD; a medication that inhibits reflux by effects on GOJ function (study #3) .


Eligibility Criteria:
Inclusion criteria:

Study #1:

* healthy male and female volunteers
* aged at least 18 and not more than 49 y
* no history of gastrointestinal symptoms
* able to communicate well with the investigators and to comply with the requirements for the entire study
* who provided written informed consent before participating in the study, after being given a full description of the trail.

Study #2 and #3:

* male and female patients with mild to moderate gastro-oesophageal reflux disease defined by presence of (1) reflux symptoms (2) pathological esophageal acid exposure between 5-10% on 24 hour ambulatory testing
* aged at least 18 and not more than 49 y
* no history of gastrointestinal symptoms
* able to communicate well with the investigators and to comply with the requirements for the entire study
* who provided written informed consent before participating in the study, after being given a full description of the trail.

Exclusion criteria:

* with present psychiatric disorders or mental impairment limiting the ability to comply with study requirements
* with use of medications influencing upper GI motility within one week of the study (i.e. beta- blocker, calcium channel blockers, nitrates, prokinetic drugs, macrolide antibiotics)
* with regular intake of medication; occasional use of analgesic e.g. aspirin, paracetamol is allowed
* with symptoms or a history of gastrointestinal disease other than gastro-esophageal reflux disease (in study #2 and #3)
* suffering from known liver, kidney, cardiovascular, neurological or pulmonary disease
* with any evidence of infectious disease
* with evidence or history of drug or alcohol abuse
* with insufficient knowledge of the German language • who, for any reason, are unable to complete the study
Meditation-Relaxation (MR Therapy) for Sleep Paralysis.

The aim of the study is to evaluate, with a small-scale pilot study, the efficacy of Meditation Relaxation therapy for Sleep Paralyses in patients with narcolepsy. The study involves two arms, with intervention with Meditation Relaxation therapy or sham over a period of three months.


Eligibility Criteria:
Inclusion Criteria:

* Narcolepsy (type 1 and 2) based on polysomnography, Multiple Sleep Latency Test \[MLST\] and CSF hypocretin level testing).
* Patients had to have experienced SP at least four times in the last month.

Exclusion Criteria:

* Psychiatric comorbidity.
Oral Hygiene Procedures on Reduction of Oral Malodor

The purpose of the study is to evaluate the effect of various oral hygiene procedures on reduction of oral malodor.

Thirty volunteers who matched with including criteria were divided randomly into two groups. Both groups were instructed to brush their teeth with a scrubbing method for the first one week. Then, each group received the different additional oral malodor reduction regimen- in addition to tooth brushing tongue cleaning in one group and chlorine dioxide (ClO2) mouthwash in another group for three consecutive weeks. After that, all the participants were instructed to practice all the three oral hygiene procedures (tooth brushing, mouth washing, tongue cleaning) the last one week. Total volatile sulfur compounds (VSCs) measured by breathtron, tongue coating, plaque score and bleeding on probing (BOP) were outcomes of this study.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of oral malodor
* At least 20 functional teeth
* No systemic diseases
* No severe dental diseases

Exclusion Criteria:

* Habit of smoking and betel quid chewing
* Oral malodor by food and other craniofacial abnormalities
* Current use of any kind of mouthwash
Uptake and Biodistribution of 18F-fluorocholine in Histiocytic Disorders by PET Imaging and Biopsy Measurement

The main purpose of this study is to discover how 18F-cholineFCH distributes in the body, and see if it can distinguish active histiocytes (tumor) from inflammatory (non- tumor) cells. This tracer has the potential to give the investigators' team more information when trying to identify the tumor cells that are most important to collect with biopsy. In addition, the study will measure levels of 18F-cholineFCH in the biopsy tissue.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Suspected but pathologically unconfirmed diagnosis of Erdheim-Chester disease or Langerhans cell histiocytosis or other histiocytic disorder on the basis of clinical diagnosis, radiologic features, or findings from prior biopsies

Or

* Confirmed diagnosis of Erdheim-Chester disease or Langerhans cell histiocytosis or other histiocytic disorder and requiring additional diagnostic imaging and biopsy to determine mutational status in order to determine therapeutic options.

Exclusion Criteria:

* Inability to undergo or cooperate with PET/CT scan (e.g., claustrophobia)
* Pregnant or nursing female
Safety and Feasibility of Amniotic Fluid as a Treatment for COVID-19 Patients

The purpose of this study is to explore the effectiveness of processed human amniotic fluid as a treatment for COVID-19.

Past use of human amniotic products (i.e., membrane and fluid) has previously been FDA-approved as a human cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) under 21 CFR 1271 for tissue injury; and has been used to reduce inflammation and fibrosis in patients with a variety of ailments. Given this, the investigators hypothesize that intravenously (IV) administered processed sterile filtered amniotic fluid will reduce inflammation in COVID-19 patients, and improve secondary clinical outcomes. Specifically, the investigators hypothesize that patients who receive IV administered hAF will see a 50% reduction in mean C-reactive protein levels following treatment.

Data sharing: Trial results will be published in peer reviewed publications upon completion of analysis.

Eligibility Criteria:
Inclusion criteria:

1. Age \>18
2. SARS CoV-2 laboratory positive test, obtained within 14 days of enrollment
3. Hospitalized
4. COVID-19 symptomatic (cough, fevers, shortness of breath, and/or sputum production)
5. Has a room air pulse oximetry of ≤94% and requires supplemental oxygen therapy
6. Patients of childbearing potential who agree to use acceptable methods of contraception for 90 days after last administration of study investigational product (IP)
7. Patients who are receiving standard of care therapies for COVID-19 that are not FDA approved are eligible for this study
8. Subjects must be able to consent to the study (i.e., Glasgow Coma Scale score of ≥14)
9. Patients are required to have controlled blood pressure of \<160/96 and a pulse of \<110.

Exclusion criteria:

1. Patients on invasive mechanical ventilation (e.g., endotracheal intubation)
2. Chronic home oxygen utilization
3. Home or current use of immunosuppressive medications (including steroids)
4. Women who are pregnant, breastfeeding, or become pregnant during the study
5. Patients on non-invasive positive pressure ventilation
6. Patients on \>12 liters per minute via non-rebreather (NRB) or \>80% oxygen via high flow nasal cannula
7. Patients who, in the opinion of the PI, have impending respiratory failure, defined as requiring rapidly escalating oxygen supplementation
8. Patients with a hemoglobin \<9 mg/dL
9. Patients diagnosed with Stage 4 or 5 chronic kidney disease (CKD)
10. Patients with diagnosed New York Heart Association (NYHA) class 4 or 5 congestive heart failure
11. Patients with a left ventricular assist device (LVAD)
12. Patients with thromboembolic phenomena
13. Patients with Type 2 and above heart block
14. Patients with established positive bacterial blood cultures prior to enrollment
15. Patients with ongoing pericardial effusion or ascites
16. Patients with clinically significant arrhythmia
17. Patients with liver function tests (ALT or AST) \>3x normal
18. Patients with untreated HIV infection
19. Patients diagnosed with end-stage organ disease
The Effects of Cathodal tDCS on Muscle Strength in Healthy Adults

To investigate the effects of different intensity of cathodal tDCS on muscle strength in healthy adults.

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that can modulate cortical excitability. In 2000, Nitsche and Paulus reported the polarity-dependent effect of tDCS in humans, i.e., anodal tDCS facilitates cortical excitability while cathodal tDCS decreases it. (Nitsche \& Paulus, 2000). TDCS studies have been replicated by many researchers and reported similar effects of tDCS in humans when using anodal and cathodal tDCS with an intensity of 1 mA. The linear effect of tDCS also has been reported by various studies, i.e., when increase intensity, the polarity-dependent effect of tDCS also enhances. However, conflicting results of cathodal tDCS efficacy have been reported.

Cortical excitability has been used to represent the efficacy of tDCS on neuroplasticity. The linear effect of cathodal tDCS on cortical excitability have been reported by researchers when using intensities at 1, 2, and 3 mA stimulated at the primary motor cortex in healthy participants (Batsikadze et al., 2013; Jamil et al., 2017; Kuo et al., 2013; Mosayebi Samani et al., 2019; Nitsche et al., 2003). Nevertheless, some studies showed the non-linear effects of cathodal tDCS (i.e., when increases intensity, cathodal tDCS enhances the cortical excitability) when using intensities at 1.5 and 2 mA in healthy participants (Batsikadze et al., 2013; Jamil et al., 2017; Mosayebi Samani et al., 2019). Hence, cathodal tDCS efficacy on cortical excitability is still controversy.

Muscle performance is an outcome that represents clinical change induced by tDCS. Previous studies reported the tendency of cathodal tDCS efficacy in decreasing muscle performance of both upper and lower extremities in healthy participants (Cogiamanian et al., 2007; Tanaka et al., 2009). However, previous studies used a single intensity of tDCS in each study. Hence, there was no direct comparison between different intensities of cathodal tDCS on muscle performance in healthy participants.

In our study, we aim to investigate the effect of different intensities of cathodal tDCS on muscle strength in healthy participants.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female healthy adults
2. Age range between 18 - 60 years old
3. Right-handed dominant identified by the Edinburg Handedness Inventory
4. No recent muscle injuries of both limbs for a past 6-months

Exclusion Criteria:

1. Consumed caffeine within 24 hours prior the experiment
2. History of neurological symptoms i.e. seizures, weakness, loss of sensation or unclear history of pass illness
3. Presence of metal implantation, intracranial shunt, cochlear implantation or cardiac pacemakers
4. Presence of opened wound or infectious wound around scalp
5. Presence of pain in evaluating muscle groups
6. History of surgery in evaluating limbs
Bone Quality Lyon Orleans

QUALYOR is a prospective study on the predictive value for fragility fracture of various new techniques assessing bone quality, among postmenopausal women with low bone mass.


Eligibility Criteria:
Inclusion Criteria:

* 50 or older women
* post-menopausal since at least one year
* with osteopenia (T-score between -1.0 and -2.5 (with clinical factor risk) or -3.0 (without clinical factor risk)

Exclusion Criteria:

* corticosteroid therapy \> 3 months, at least 7.5mg/day equivalent prednisolon (stopped since at least 1 year)
* osteoporosis treatment antecedent
* fragility fracture antecedent
* on going post-menopausal hormonal treatment
* clinical signs of hepatic, cardiac or respiratory insufficiency, diseases possibly affecting bone metabolism
* life expectancy \< 4 years, mental or serious illness
A Multicenter, 4-week Crossover (Total Duration 12 Weeks) to Determine the Impact of QVA149 on Nocturnal Oxygen Levels in Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study was to determine whether a fixed dose combination of indacaterol and glycopyrronium (QVA149) has an impact on night-time blood oxygen levels in Chronic Obstructive Pulmonary Disease.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COPD (according to GOLD guidelines, updated 2014) with a post-bronchodilator FEV1/FVC \<0.70
* Patients with a post-bronchodilator FEV1 ≥30% and \<60% of the predicted normal value
* Resting daytime oxygen saturation levels measured by pulse oximetry of ≤95% SpO2
* Smoking history of at least 10 pack years (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years)

Exclusion Criteria:

* An exacerbation of COPD (treatment with oral or parenteral antibiotics and/or glucocorticosteroids and/or hospitalization related to COPD) within 4 weeks prior to screening or during the run-in period
* Diagnosed asthma
* Patients receiving regular long term oxygen therapy (LTOT)
* Ongoing / planned rehabilitation during the study period
* Three or more awakenings during the night leading to toilet visit or other reasons for exiting the bed during the last week prior to the screening visit due to non-COPD reasons

Other protocol-defined inclusion/exclusion criteria may apply.