cyrilzakka/clinical-trials huggingface dataset:
Effect of Light-emitting Diode (LED) Photobiomodulation Therapy on Muscular Fatigue in University Handball Athletes

Introduction: Low-intensity laser therapy (LBI) is a therapeutic modality with a large number of clinical studies in recent years, taking into account its effectiveness in tissue repair, pain control and, more recently, to increase performance. It is known that LED therapy has immediate effects. Therefore, analyzing the TLED in the infrared spectrum for acute responses at different times along with fatigue resistance capabilities, heart rate variability and biochemical response to fatigue in handball athletes becomes necessary. Objective: To analyze the acute effects of LED phototherapy (940nm) on fatigue resistance and recovery after strenuous exercises of university athletes. Method: The study sample will consist of 32 and 36 male athletes, for biceps brachii and quadriceps femoris, respectively. The athletes will be randomly assigned into four groups: Immediate TLED (TLED-I), TLED 15Min (TLED-15), Immediate Sham (Sham-I) and Sham 15Min (Sham-15). The tests performed will involve bioimpedance evaluation, blood lactate, electromyographic analysis and evaluation of maximum voluntary contraction by means of the maximal repetition test (1RM). Thus, the TLED will be applied on the muscle group to be evaluated, unilaterally, the same tests being repeated in the sequence. For analysis of the data, normality test will be used to verify the distribution and adequate statistical tests for the appropriate intra and intergroup comparisons, being considered two factors in the comparisons, time and group. A significance level of 5% will be adopted.

It is a blinded randomized clinical trial. The athletes will undergo a previous evaluation (day 1) comprised by anamnesis and evaluation of the bioimpedance to analyze the body composition, will still carry out the evaluation of the load for a maximum repetition. Thus, 7 days after (day 2) the previous evaluation in the times immediately after and after 15 minutes of the LED application will be carried out new tests. These will involve assessment of blood lactate, heart rate variability and electromyography. In addition, during the execution of the fatigue protocol will be collected the number of repetitions of muscle contraction and its total execution time.

Due to the number of athletes that make up the university team (n = 19), cross-over will be necessary, where all athletes will initially be distributed to the 04 pre-defined groups in each subproject, and after the 7 days, they will be divided again.

Eligibility Criteria:
Inclusion Criteria:

* Handball practitioners;
* Absence of musculoskeletal injury in the last three months;
* Absence of anti-inflammatory and / or analgesic drugs 72 hours before the evaluations

Exclusion Criteria:

* Use of anabolic steroids;
* Presence of cardiovascular disease
* Use of alcohol and illicit drugs during the collection period
GenI: a Tool to Generate Paramedical Research Ideas

In order to develop paramedical research culture, the paramedical staff need adapted tools and methods. The GenI project (Research ideas generation) has for main objective the design and validation of a tool that will allow the identification of paramedical research ideas. This tool will be built based on paramedical staff views. Our hypothesis is that the use of the GenI tool will help to detect research ideas in paramedical health care that could lead to research projects.


Eligibility Criteria:
Inclusion Criteria:

* paramedical staff working in one of the 4 hospitals involved in the study

Exclusion Criteria:

* paramedical staff with a research degree
* paramedical staff that are paramedical coordinator in the hospital
Expanded Access Use of Ladiratuzumab Vedotin in Advanced Solid Tumors

The purpose of this study is to provide the option of Ladiratuzumab Vedotin treatment to eligible patients in studies SGNLVA-005.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease (MK-0431-073 AM1)

The purpose of the study is to compare sitagliptin and glipizide in lowering blood sugar in participants with type-2 diabetes mellitus (T2DM) and end-stage renal disease on dialysis who do not have adequate glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* Participant has T2DM.
* Participant is on dialysis on day of signing informed consent.
* Participant is unlikely to conceive or uses acceptable methods of birth control: hormonal contraceptive, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, or vasectomy.
* Participant has hemoglobin A1c ≥7% and ≤9% measured at or within 2 weeks prior to Visit 4/Week -2.
* Participant is ≥85% compliant with study medication during the single-blind placebo run-in (as determined by tablet/capsule count) and compliant with diet, exercise and other run-in treatments during the run-in period.

Exclusion Criteria:

* Participant has a history of type 1 diabetes mellitus or a history of ketoacidosis.
* Participant is losing weight in a weight loss program and is not in the maintenance phase (defined as \<2 kg weight loss in 2 months), or intends to be involved in weight loss intervention outside that prescribed by the study.
* Participant has a clinically significant hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia).
* Participant has cirrhosis or active liver disease.
* Participant has been on dialysis for \< 6 months.
* Participant has been diagnosed with a significant cardiovascular disorder and has new or worsening signs or symptoms of congestive heart failure within 3 months of signing informed consent.
* Participant has severe active peripheral vascular disease.
* Participant has a history of malignancy ≤ 5 years prior to signing informed consent, or \> 5 years without documentation of remission/cure.
* Participant is under treatment for hyperthyroidism.
* Participant has a hypersensitivity or contraindication to glipizide.
The Effects of TMS on Memory-consolidation in Human Primary Visual Cortex

Rapid Transcranial Magnetic Stimulation will be used in order to examine whether the human primary visual cortex is essential to visual memory consolidation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Right handed

Exclusion Criteria:

* Active/past neurological/psychiatric disorder
* Personal/first-degree history of seizures
* Cardio-vascular disorder or disease including hypertension chronic use of medication
* Metal/electronic device implant
* Pregnancy
Phytomedicines Versus Hydroxychloroquine as an Add on Therapy to Azythromycin in Asymptomatic Covid-19 Patients

Our previous work on plants has indicated significant antimalarial and antiviral activities. Of these plants, two recipes are proposed for evaluation for COVID-19. It is Cinchona, an antimalarial and a combination of 4 plants with antiviral, antimalarial, antitussive and anti-inflammatory properties.

The phase II clinical trial, with three arms and at a rate of 77 patients per arm, received the approval of the National Committee for Ethics and Health Research. This is a non-inferiority test aimed at comparing the therapeutic impact in "add on" to Azithromycin, phytomedicines versus Hydroxychloroquine in asymptomatic COVID-19 patients.

After 10 days of treatment, viral clearance and symptom progression will be assessed on days 3, 6 and 14. Clinical, paraclinical and laboratory tests will be performed throughout the 3-month trial. Ethical and deontological considerations will be applied

All consenting subjects who meet the inclusion criteria will benefit from an individual file which will include data relating to general information, the complete clinical examination and the paraclinical examination. They are distributed randomly into three parallel groups, each arm having a different treatment modality. A balanced randomization by permutation block of 5 will be applied using the "Randomizer for Clinical Trial" application developed by the company Medsharing). Laboratory examinations are carried out according to the procedures and method by laboratories accredited in Guinea for the diagnosis of COVID19. Data is encoded, entered and processed using statistical software.

The comparison between the three cohorts will be made using either the Anova test for continuous variables or the chi-square test for categorical variables. The rate of change over time of virologic clearance, fever and other symptoms values as well as the differences for these rates between treatment arms will be tested using mixed-effects modeling.

The biological samples will be stored at the biobank of the National Institute of Public Health of Guinea.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients are adults with COVID-19 confirmed by a positive PCR (Polymerase Chain Reaction) test and without symptoms

Exclusion Criteria:

* any patient hypersensitive to hydroxychloroquine or under traditional herbal treatment in the two weeks preceding inclusion,
* any patient with other acute or chronic illnesses such as heart failure, arterial hypertension, renal failure, hepatocellular failure, tuberculosis or unable to take the oral treatment;
* any patient for whom one of the treatments under study is contraindicated according to the doctor's opinion.
* pregnant women,
* severe neurological manifestations
"Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients"

The aim of this study is to evaluate the effect of pentoxifylline 400 mg twice daily administration on the prevention of paclitaxel-Induced peripheral neuropathy in breast cancer patients.

Paclitaxel induced peripheral neuropathy (PIPN) starts early during therapy and may worsen even after cessation and affect mainly sensory neurons. The symptoms of neuropathy include pain, tingling, cold-sensitivity and numbness that typically presents in a stocking glove distribution. The pathogenesis of PIPN may be attributed to drug accumulation in dorsal root ganglia causing increase in inflammatory cytokines, immune mediators and dysregulation of calcium subunits which in turn increases pain. It also causes oxidative stress in sensory axons leading to axon demyelination, increased sensitization to signal transduction, release of pro-inflammatory mediators and activation of apoptosis.

Many animal studies and clinical trials have shown pentoxifylline to have a significant anti-inflammatory and antioxidant effect. It also preserved nerve conduction velocity and ameliorated mechanical hyperalgesia. Pentoxifylline showed a prominent reduction in neuropathic pain in diabetic patients. These effects were mainly due to the ability of pentoxifylline to reduce TNF-α and MDA levels. So, pentoxifylline is a drug of interest due to its ability to ameliorate neuro-inflammation and oxidative stress which play a critical role in PIPN pathogenesis.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18-80 years old).
* Female patients.
* Pathologically proved breast cancer.
* Breast cancer patients who will receive adjuvant and neoadjuvant weekly paclitaxel for 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance ≤ 2
* Adequate bone marrow function.
* Adequate liver and kidney function.

Exclusion Criteria:

* Patients with preexisting clinical neuropathy.
* Patients with diabetes mellitus.
* Metastatic breast cancer.
* Patients receiving medications that ameliorate neuropathy like; antidepressants, anticonvulsants, opioids, adjuvant or topical analgesics.
* Patients treated with medications that increase the risk of neuropathy.
* Hypersensitivity to pentoxifylline or xanthine derivatives.
* Patients with recent (within 1 month) surgery, myocardial infarction (MI), intracranial or retinal bleeding or active peptic ulcer.
* Patients at high risk for bleeding or taking medications that increase risk of bleeding.
Study to Evaluate the Efficacy and Safety of CKD-350

The purpose of this study is to compare the efficacy and safety of CKD-350 in patients with dry eye syndrome

Active controlled, randomized, double-blind, multi-center, phase 3 trial to evaluate the efficacy and safety of CKD-350 eye drops in patients with dry eye syndrome

Eligibility Criteria:
Inclusion Criteria:

1. More than the age of 19 years old
2. Subjects with dry eye symptoms for at least 3 month prior to screening
3. Subjects who have following values 1) ≥ 2 point of corneal staining score 2) ≤ 10 seconds of Tear Break-up Time 3) ≤10mm/5min of Schirmer I Test
4. Subjects who have a visual acuity equal to or better than 0.2 in both eyes
5. Subjects who sign on an informed consent form willingly

Exclusion Criteria:

1. Subjects who have clinically significant ocular surface diseases, abnormal corneal susceptibility and abnormal epiphora
2. Subjects who have medical history following 1) Abnormal eyelids function including abnormality of eyelid or eyelash 2) Ophthalmology operation within 1 year 3) Active ocular infection at present or treatment of allergic eye diseases 4) Herpetic keratopathy, conjunctiva scar from cicatricial keratoconjunctivitis(alkali injuries, stevens-johnson syndrome, ocular cicatricial pemphigoid), pterygium, congenital lacrimal gland absence, neural keratitis, keratoconus
3. Subjects who have received occlusion therapy with lacrimal or punctal plugs within 3 months or have a surgery plan in clinical trial
4. Subjects who wore contact lenses within 3 months or need to wear contact lenses during the study
5. Subjects who take steroidal or immunosuppressive drug within 1 month
6. Over 22mmHg IOP(Intraocular Pressure)
7. Subjects who have malignant tumor within 5 years
8. Subjects with known hypersensitivity to investigational product
9. Women who are nursing, pregnant or planning pregnancy during the study
10. Subjects who have received any other investigational product within 1 month prior to the first dosing
11. Impossible subjects who participate in clinical trial by investigator's decision
Status Telemetry for Cochlear Implantations

Cochlear implants (CIs) are well-established neuroprosthesis used to restore hearing for patients with partial or complete deafness. However, the audiological outcomes of these implants can vary widely, and one reason for this is suboptimal electrode placement. The gold standard for measuring electrode positions is computed tomography (CT) scans, but they are expensive and expose patients to additional radiation, which is especially harmful for children.

This study investigates an alternative approach using impedance telemetry data to estimate electrode positions without exposing patients to radiation. For this purpose, an extended telemetry version of a CE-certified cochlear implant software is used. The advanced impedance telemetry software can measure impedance subcomponents with improved measurement resolution that could be used for more accurate estimation of electrode insertion depth using specially designed estimation software.

Ultimately, the investigators want to demonstrate the potential to improve audiological outcomes of cochlear implant recipients without exposing them to additional radiation.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent signed by the subject
* Subjects scheduled for CI surgery according to clinical routine
* Subjects who will receive a cochlear implant of the MED-EL portfolio (FLEX series arrays)
* No radiological contraindications
* Stated willingness to comply with all study procedures for the duration of the study

Exclusion Criteria:

* Lack of compliance with any inclusion criteria
* Subjects incapable of giving informed consent
* Age under 18 years
* Pregnancy
Safety and Efficacy of Insulin Aspart in Children With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to evaluate safety and efficacy in children with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Treatment with insulin for at least 6 months prior to inclusion
* HbA1c below or equal to 11.0 %
* Currently treated with short acting, intermediate acting, long acting human insulin or analogues or a self-mix of these insulins at least 1 month prior to inclusion

Exclusion Criteria:

* The receipt of any investigational drug within one month prior to this trial
* Recurrent severe hypoglycaemia or hypoglycaemic awareness as judged by the investigator
* Total daily insulin doses at least 1.80 IU/kg
* Treatment with oral hypoglycaemic agents
* Known or suspected allergy to trial product or related products
A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer

SHR-1316 as Maintenance therapy for limited stage small cell lung cancer without progression after first line platinum based concurrent chemoradiotherapy


Eligibility Criteria:
Inclusion Criteria:

1. The age is 18-75 years old (including both ends), regardless of gender;
2. Histologically confirmed limited stage small cell lung cancer ;
3. ECOG PS 0 \~ 1;
4. Patients received at least 2 cycles of platinum based chemotherapy and radiotherapy, and completed within 1 to 42 days before the first medication.
5. The last chemotherapy must be finished before or at the same time of radiotherapy.
6. The disease did not progress after concurrent chemoradiotherapy;
7. The expected survival time was more than 3 months;
8. Pulmonary function: FEV1 \> 70%;

Exclusion Criteria:

1. The subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
2. Mixed SCLC or NSCLC confirmed by histology;
3. Locally advanced small cell lung cancer receiving sequential chemoradiotherapy;
4. Have received anti-tumor therapy of systemic immune checkpoint inhibitors for SCLC;
5. Extensive SCLC;
6. Operable SCLC (clinical stage T1-2N0, except for those who are contraindicated or refuse surgery);
7. Interstitial pneumonia
8. History of active, known or suspected autoimmune diseases and autoimmune diseases, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.
9. HIV, active Hepatitis B or Hepatitis C infection
Outcome of FFR-guided Intervention Strategy

The investigator will evaluate the clinical outcomes of the patients in whom the treatment strategy for their coronary stenosis were determined by fractional flow reserve measurement.

Inclusion criteria

* Coronary stenosis
* Successful measurement of fractional flow reserve

Clinical outcomes

* Death
* Cardiac death
* Target lesion revascularization
* Target vessel revascularization

Eligibility Criteria:
Inclusion Criteria:

* Coronary stenosis
* Successful fractional flow reserve measurement

Exclusion Criteria:

* Contraindication to adenosine
* Expected life expectance \< 1year
Brief Intervention to Prevent Alcohol Socialization (BIPAS Alcohol)

Early alcohol socialization occurs within the family. This multi-level, high-reach, low-intensity intervention to prevent early alcohol use capitalizes on the influence of providers, immunization timing, and pediatric guidelines that advise healthcare providers to give anticipatory guidance about early alcohol use. In conjunction, the intervention capitalizes on the power of technology to reinforce and expand upon pediatrician messages.

The study seeks to understand the feasibility and effectiveness of a pilot intervention designed to prevent alcohol socialization through education of parents of rising 6th grade students.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older;
* Parent or guardian of an enrolled child at a study clinic;
* Cohabitate part time (2 days/week) or more with enrolled child;
* Be able to complete study activities in English;
* Be able to give informed consent;
* Own a phone with text message capabilities and access to internet.

Exclusion Criteria:

* Families in which the 10-to-12-year old child is actively receiving treatment for alcohol use disorder.
Defining Outcome Measures for Behavioural and Emotional Problems in Dystrophinopathies

Study aims to develop and to evaluate the neurophysiological and physiological response to a classical conditioning task.To better understand how Duchenne Muscular Dystrophy (DMD) and Becker Muscular Dystrophy (BMD) impacts mental health and how to assess it. Participants invited to complete questionnaires about behaviour, cognitive function and social interactions, complete computer tasks and have an optional MRI brain scan,

The investigation aims to develop and to evaluate the neurophysiological and physiological response to a classical conditioning task, which is comparable to findings that have been made in the mdx dystrophic mouse (deficient in Dp427). The investigators will assess correlations between the specific DMD/BMD genotype and susceptibility to conditioning, as well as the relationship between conditioning and behavioural/emotional characteristics of the syndrome. At the end of the study, the objective is to deliver a comprehensive test battery that is suitable for use in a trial of AON delivery to improve brain function.

Eligibility Criteria:
Inclusion Criteria:

* DMD patients:

  1. Male
  2. Age range 7-17 years
  3. A genetically proven diagnosis of DMD.
  4. A genetic mutation that abrogates expression of Dp427 alone (assigned in DMD Group 1: Dp427-/Dp140+) or both Dp427 and Dp140 (assigned to DMD Group 2: Dp427-/Dp140-).
  5. Ability to consent/assent

BMD patients:

1. Male
2. Age range 7-17 years
3. A genetically proven diagnosis of BMD.
4. A genetic mutation that decreases expression of Dp427 alone (assigned to BMD Group 1), of both Dp427 and Dp140 (assigned to BMD Group 2).
5. Ability to consent/assent

Control participants:

1. Male
2. Age range 7-17 years.
3. Ability to consent/assent

Exclusion Criteria:

* DMD \& BMD patients:

  1. Significant visual or hearing impairment
  2. Specific phobias or sensory sensitivities to stimuli similar to the ones used in this study
  3. Current participation in a clinical trial investigating a new drug involved in dystrophin modulation.
  4. Inability to consent (for parents/guardians or self-reporting participants aged 16 and 17) or assent. This will exclude the rare individuals with extremely severe learning disability, as the assent in these patients is impossible (or the consent in self-reporting participants aged 16 and 17).

Control participants:

1. Significant visual or hearing impairment
2. Specific phobias or sensory sensitivities to stimuli similar to the ones used in this study
3. Any diagnosis of neurological or psychiatric condition

General exclusion criteria for MRI:

1. Claustrophobia
2. Pacemakers and defibrillators
3. Nerve stimulators
4. Intracranial clips
5. Intraorbital or intraocular metallic fragments
6. Cochlear implants
7. Ferromagnetic implants (e.g. thoracic implant for scoliosis)
8. Inability to lie supine during less than 45 minutes
9. Not having a general practitioner
10. Severe learning disability which will require a general anaesthetic