cyrilzakka/clinical-trials huggingface dataset:
Effect of Low Level Laser Therapy on Hamstring Muscle Tightness and Calf Muscle Spasticity in Cerebral Palsy Children.

Background :Spasticity is a motor disorder in children with cerebral palsy (CP) Cp is a non progress lesion in unmature brain lead to a group of chronic disorders that affect movement and posture development, may be accompanied by epilepsy, secondary musculoskeletal problems, deformaties and disturbances of sensation, perception, cognition, communication, and behavior Few studies demonstrate effectiveness of laser therapies in spasticity in cp.

Methodology : This study is randomize control trail aimes to evaluate the effect of low-level laser therapy (LLLT) on the spasticity of hamstring and calf muscle in children with CP over 12 session of intermittent laser exposures. Muscle tone , gross motor function, rang of motion (rom ) and poplital angle will evaluate before and after laser irradiation in 30 children with CP both geneder aged between two to six years old diaplegic clidren , exclusion children who take botox or done surgery . Muscles will irradiated with low-intensity diode laser pulses of 808-nm wavelength three times per week over one month follow up for one month.

This is a randomized controlled study, in which the 30 children with diaplegic randomly divide into control and study groups by excel sheat on computer, each group include 15child. Each child will receive laser at a frequency of three sessions per week for 12 session, in addition to conventional physiotherapy program, while the control group have 15 child will receive conventional physiotherapy. Four variables will choose to detect the effect of laser therapy: (1) muscle tone, (2) range of motion (ROM) , (3) gross movement,(4) poplital angle assessment . These values will recorde in both groups before starting treatment and after the treatment period and after one month of stop treatment .

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Eligibility Criteria:
Inclusion Criteria:

* spastic diaplegic children aged between 2 to 6years have spastic hamstring and calf muscle .

Exclusion Criteria:

* for post-operative children , children who take botox, children with contracture or fixed deformity
Prospective, Observational Clinical Investigation of the Exos Reformable Brace

This is a prospective observational single cohort trial quantifying time to radiographic union (primary endpoint) and convenience, satisfaction, pain and resource requirements (secondary) for patients with non-operatively treated distal radius fractures managed with a thermoformable Exos short-arm brace.

The trial will be a prospective trial of a convenience sample of skeletally mature patients with radiographically-confirmed distal radius fractures that can be managed without ORIF. The study population will be defined as all adult patients (\>18 years) with stable, non-displaced distal radius fractures. All patients will be independent in activities of daily living. Patients will be screened as candidates for enrollment into the study and if the patient satisfies the inclusion/exclusion criteria, a clinical research coordinator or the study PI/coPI will explain all essential elements of the clinical trial. If the patient agrees to participate, the study coordinator or PI/coPI will obtain informed consent. The patient will still be followed clinically per the PI/coPI's standard of care.

Eligibility Criteria:
Inclusion

* Age \> 18 years;
* Unilateral fracture of distal radius without misalignment (dorsal angulation \<10°, axial radial shortening \<5mm), \<2mm intraarticular stepoff;
* Independent in activities of daily living;
* Capable and willing of signing informed consent.

Exclusion

* Children under the age of 18;
* Fracture of the contralateral arm;
* Other fractures of the ipsilateral arm;
* Open fractures;
* Fractures that require reduction.
A Comparison of Ultrasound Versus Fluoroscopic Guidance for Sacral Lateral Branch Blocks

Sacral lateral branch blocks are used for the diagnosis and treatment of sacroiliac joint pain. This study will compare ultrasound and fluoroscopy guidance for sacral lateral branch blocks. Outcomes examined will include performance times and success rates.


Eligibility Criteria:
Inclusion Criteria:

* Any consenting patient over 18 years of age, undergoing a diagnostic sacral lateral branch block for suspected sacroiliac joint related pain.

Exclusion Criteria:

* Inability to consent, iodine or lidocaine allergy, pregnancy, coagulopathy (as defined by an international normalized ratio over 1.4, platelets under 100,000, or a documented bleeding disorder) and inability to visualize the target areas necessary for sensory testing (posterior superior iliac spine, dorsal aspect of SIJ) under ultrasound guidance.
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injection of JNJ-64304500 in Healthy Japanese and Caucasian Male Participants

The primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) following single-dose subcutaneous (SC) injection of JNJ-64304500 in healthy Japanese male participants.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have signed an informed consent document prior to any study related procedures indicating that they understand the purpose of the study including the procedures required and are willing to participate in the study
* Participant must be willing and able to adhere to the study visit schedule, prohibitions and restrictions specified in the protocol, and other protocol requirements
* Participant must have a body weight in the range of 60 to 90 kilogram (kg), inclusive, and a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m\^2)
* Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. This determination must be recorded in the participant's source documents and initialed by the investigator
* Participant must be a non-smoker for at least 3 months prior to study enrollment

Exclusion Criteria:

* Participant has a history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* Participant has an active acute or chronic infection (including chronic recurrent or invasive candidiasis) or diagnosed latent infection
* Participant has or has had a serious infection (example, sepsis, pneumonia or pyelonephritis), or have been hospitalized or received intravenous (IV) antibiotics for a serious infection during the 2 months prior to screening
* Participant has ever had a nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, pneumocystosis, and aspergillosis) prior to screening
* Participant has a history of active granulomatous infection, including histoplasmosis or coccidioidomycosis prior to screening
* If participant has had a chest radiograph within 3 months before study drug administration radiograph that shows an abnormality suggestive of a malignancy or current active infection, including tuberculosis (TB)
Nicotine Replacement and Counseling In Adolescents

The objective of this pilot study is to determine the feasibility and utility of using the nicotine nasal spray (NNS) in adolescent smokers who want to quit smoking.


Eligibility Criteria:
Inclusion Criteria:

* Be between 15 and 18 years-old
* Smoke 5 or more cigarettes per day (cpd) for at least 6 months and want to quit smoking.

Exclusion Criteria:

* Adolescents who were using or had used nicotine replacement in the prior week were excluded.
* Those who used bupropion (Zyban®) within the past 30 days were also excluded.
Safety and Tolerability Study of GSK1120212, a MEK Inhibitor, in Combination With Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or Nab-Paclitaxel

The purpose of this study is to determine what dose of GSK1120212 can be given safely in combination with at least one other drug that is already approved to treat cancer. This study will test the safety of up to 6 different GSK1120212 study treatment combinations (GSK1120212 plus either docetaxel, erlotinib, pemetrexed, pemetrexed + carboplatin, pemetrexed + cisplatin, or nab-paclitaxel). The doses identified in this study may be used in future trials to test whether the combination treatment is a safe and effective therapy for subjects with metastatic lung and/or pancreatic cancers.


Eligibility Criteria:
Inclusion Criteria:

* The subject has a solid tumor. Expansion cohorts are limited to non-small cell lung cancer and/or pancreatic cancer with or without a KRAS mutation.
* Tumor progression following at least one prior standard therapy, the subject refuses standard therapy, or no standard therapy exists.
* The subject has a radiographically measurable tumor.
* The subject is able to carry out daily life activities without difficulty.
* The subject is able to swallow and retain oral medication.
* The subject does not have significant side effects from previous anti-cancer treatment.
* The subject has adequate organ and blood cell counts.
* Sexually active subjects must use medically acceptable methods of contraception during the course of the study.

Exclusion Criteria:

* The subject has had major surgery or received certain types of cancer therapy within 2-3 weeks before starting the study.
* The subject has a brain tumor.
* Current severe, uncontrolled systemic disease.
* History of clinically significant heart, lung, or eye/vision problems.
* The subject has high blood pressure that is not well-controlled with medication.
* The subject has a permanent pacemaker.
* The subject is pregnant or breastfeeding.
* Positive for Hepatitis B, Hepatitis C, or HIV.
The Effect of Pomegranate Juice on Oxidative Stress in Hemodialysis Patients

Pomegranate juice (PJ) consumption by hemodialysis patients will reduce the oxidative stress and the incidence of infections, cardiovascular events and mortality.

The mortality rate in patients with end stage renal failure is substantially higher than in the general population, and deaths are mainly attributable to cardiovascular diseases and infections. There is accumulating evidence that supports the role for oxidative stress in damaging the immune system and in the pathogenesis of cardiovascular diseases in hemodialysis patients, therefore antioxidative treatment, which will reduce oxidative stress, may be beneficial.

Pomegranate juice contains antioxidants such as soluble polyphenols, tannins and anthocyanins and was shown to have anti-inflammatory, anti- bacterial and anti-atherosclerotic properties in mice and humans. However,the effects of pomegranate juice on oxidative stress, infections and cardiovascular events in hemodialysis patients are still not documented.

This is a randomized preventive intervention trial on hemodialysis patients from one dialysis centre in Israel. The patients will be enrolled and randomized to receive pomegranate juice or placebo. Patients will be followed for one year. The objective of this study is to investigate the effects of pomegranate juice (PJ) consumption by hemodialysis patients on the changes in oxidative stress and the incidence of infections, cardiovascular events and mortality.

Eligibility Criteria:
Inclusion Criteria:

* End Stage Renal Disease, stable chronic hemodialysis \> 3 months
* Informed Consent.
* Man and women over 18 years.

Exclusion Criteria:

* Hemodialysis \< 3 months
* Participation in other clinical trial
* Not eligible according to physician decision
The Adjunctive Effect of Soft Tissue Augmentation Procedures of Moderate-severe Peri-implantitis

The key objective of the study is to compare the effects of soft tissue augmentation using a volume stable collagen matrix or autogenous connective tissue graft or no soft tissue augmentation in addition to bone grafting/implantoplasty in patients who undergo surgical therapy of peri-implantitis with respect to clinical resolution of the infection.

The global burden of periimplantitis is expected to rise with the increasing popularity of dental implants as a replacement option. While many therapeutic interventions have been proposed, none have been proven superior. Surgical therapy is often indicated to gain access to the plaque infected implant threads and bone defects. Implantoplasty of suprabony defects have shown good results although adverse effects like soft tissue recession are common.

Thin mucosa results in compromised outcomes following various surgical interventions around implants with increased recession and aesthetic failures. It has also been associated with increased marginal bone loss and severity of periimplantitis. Application of autogenous connective tissue grafts during surgical therapy of periimplantitis to increase the keratinised mucosa widths or attenuate post-implantoplasty recession showed promising results.

No randomized controlled clinical trials investigating the effects of additional soft tissue augmentation with implantoplasty on periimplantitis lesions have been done so far. In addition, few have evaluated patient reported outcome measures, included non-European subjects and none reported on soft tissue alterations. The effect of soft tissue substitutes on surgical periimplantitis therapy remains unknown.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old (UZH, FRA) or \> 21 years old (SIN), male and female.
2. Diagnosed with periimplantitis of at least 1 implant in function for at least 1 year Diagnostic criteria

   * Presence of bleeding and/or suppuration on gentle probing.
   * Probing depths of ≥6 mm.
   * Bone levels ≥3 mm apical of the most coronal portion of the intraosseous part of the implant.
3. Periodontal health (including previously treated periodontitis patients with reduced but healthy periodontium)
4. Good oral hygiene (full mouth plaque score \<25%)
5. Adequate control of inflammation (full mouth BOP \<25%)
6. Signed informed consent form

Exclusion Criteria:

1. Pregnant or lactating female patient at inclusion
2. Allergy or objection to porcine and bovine implantable biomaterials
3. Allergy to Penicillin or NSAIDs
4. Known or suspected non-compliance, drug or alcohol abuse
5. Inability to follow the procedures of the study, e.g. due to language/ comprehension problems, psychological disorders, dementia, etc. of the participant
6. Smoking \> 15 cigarettes a day
7. Active periodontal disease
Molecular Characterization of Primary Mucosal Melanoma

Primary mucosal melanomas (MPM) are rarer than cutaneous melanomas, but also more severe. They are usually refractory to conventional approaches, regularly excluded from major therapeutic programs and not sensitive to new targeted therapies orphans. " The identification of therapeutic targets and accessibility to existing, developing or future targeted therapies improves the survival of patients with MPM.

The principal goal is to describe, using a large panel of genes, the prevalence of major mutations in a cohort of MPMs based on the population of a French region.


Eligibility Criteria:
Inclusion criteria:

* Incident Mucosal melanoma in the Champagne-Ardenne region 2004-2014

Exclusion criteria:

* Cutaneous melanoma
* Uveal melanoma
A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients

To characterize the safety and efficacy of fixed doses of MDL 28,574A administered alone and in combination with zidovudine ( AZT ) in patients with asymptomatic or mildly symptomatic HIV infection. To examine the demographic effects on population pharmacokinetics and pharmacodynamics of MDL 28,574A alone and in combination with AZT.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV infection.
* Asymptomatic or mildly symptomatic.
* CD4 count 100 - 300 cells/mm3.

Prior Medication:

Allowed:

* Prior antiretroviral agents for up to 6 months per agent.

Exclusion Criteria

Co-existing Condition:

Patients with the following condition are excluded:

Unable or unwilling to comply with study procedures.

Concurrent Medication:

Excluded:

* Chemoprophylactic therapy for mycobacterial infection.
* Any nonstudy prescription medications without approval of investigator.

Patients with the following prior conditions are excluded:

* History of grade 3 or 4 toxicity to \<= 600 mg/day AZT.
* History of intolerance to lactose.
* Chronic diarrhea within 6 months prior to study entry.
* Unexplained intermittent or chronic fever, defined as temperature \>= 38.5 C for any 7 days within the 30 days prior to study entry.

Prior Medication:

Excluded:

* Antiretroviral therapy within 2 weeks prior to study entry.
* Prior HIV vaccines.
* Biological response modifiers within 30 days prior to study entry.
* Prior foscarnet.
* Any investigational drug with a washout \< 5 half-lives prior to study entry.
* Any medications known to alter renal, hepatic, or hematologic / immunologic function (such as barbiturates, phenothiazines, cimetidine, immunomodulators, etc.) within 14 days prior to study entry.

Recent history of alcohol and/or drug abuse.
Water Content in E-Liquids

This study looks at the effect of manipulating the water concentration of certain e-liquids on sensory perception.

This study looks at the effect of manipulating water concentration on e-cigarettes that contain aldehyde flavor chemicals on sensory perception. Regular e-cigarette users will be asked to complete 2 lab sessions in which they will sample 4 nicotine containing e-liquids. Each e-liquid will be sampled in four water concentration manipulations. Researchers will examine influence of flavor and water concentrations on sensory experience including appeal/liking and irritation and harshness.

Eligibility Criteria:
Inclusion Criteria:

* at least 21 years old
* able to read/write
* \>/= 6 mths e-cig use
* regular e-cig use (\>/= 4 days/week)
* use of flavored e-cigs
* use of nicotine containing e-cigs
* urine cotinine \>/= 200ng/ml
* no plan to quit e-cig use

Exclusion Criteria:

* breastfeeding, pregnant, trying to become pregnant
* Medical conditions that increase risk of respiratory problems among participants
* Current use of illegal substances
* Medical conditions increasing risk of respiratory problems in nonpatient populations
* Current diagnosis of an untreated psychiatric condition
* Not fully vaccinated for Coronavirus-19
Brain Emotion Circuitry-Targeted Self-Monitoring and Regulation Therapy (BE-SMART)

New treatments to help to reduce the emotional dysregulation of mood disorders are critically needed. This is a study of an emotional dysregulation psychotherapy treatment in which participants will learn skills to help to down-regulate maladaptive emotional responses and learn beneficial, healthy habits. Investigators will perform symptom and behavioral assessments and scanning prior to the treatment and will then repeat scanning, symptom and behavioral assessments at the midpoint, and after the psychotherapy is completed. This collected information will assess whether the treatment can improve functioning of emotion regulation brain circuitry.

Aim: To use functional magnetic resonance imaging (fMRI), before, at mid point, and after an emotional regulation intervention, to assess intervention-associated changes in brain circuitry responses to emotional stimuli.

Hypothesis : The emotional regulation psychotherapy treatment will be associated with changes in emotional regulation circuitry.

At the time of registration, the primary outcome "Changes in Functioning of Emotional Brain Circuitry" was the only outcome registered. This outcome is comprised of multiple measurements and was split up individually at the time of results entry and the original primary outcome measure was deleted.

Eligibility Criteria:
Inclusion Criteria:

* participants meeting Diagnostic and Statistical Manual Fifth Edition (DSM-5) criteria for BDI, BDII or BD Other Specified Bipolar (BD-OS).
* participants with mood symptoms, such as Hamilton Depression Rating Scale (Ham-D) score ≥ 15 and/or for hypomania/mild mania such as Young Mania Rating Scale (YMRS) ≥ 12.

Exclusion Criteria:

* history of significant medical illness, particularly illness associated with possible changes in cerebral tissue or cerebrovasculature (e.g. hypertension)
* history of neurologic abnormality, including significant head trauma (defined by loss of consciousness of ≥5-minutes duration), seizure disorder, cerebrovascular or neoplastic lesion, or neurodegenerative disorder.
* contraindication to MRI scanning, e.g. presence of a ferromagnetic object, including orthodontic braces, or claustrophobia.
* intelligence quotient (IQ) lower than 70
* pregnancy
* alcohol/substance use may be permitted if participant does not meet for DSM-5 current use disorder but will not be permitted for illicit substance use in the week prior to study.
China PEACE 5r-HF Study

This study will use a two-stage random sampling design to create a nationally representative sample of patients with heart failure (HF) in China. The investigators sought to describe the clinical profiles, to assess treatment patterns and in-hospital outcomes for HF, and to identify targets for care quality improvement.

This study will use a two-stage random sampling design to create a nationally representative sample in China, and randomly sample patients with HF as a primary diagnosis, and were admitted to hospital from January 1st, 2015 to December 31st, 2015. The sample size is estimated to be 10,000.

The investigators will collect photocopies of the sampled medical records and centrally abstract detailed information, which included demographic characteristics, medical history, clinical features, diagnostic tests, in-hospital procedures, lab tests, treatments, and in-hospital outcomes. Data abstraction quality was monitored by random auditing of 5% of the medical records, with overall variable accuracy exceeding 98%.

Analyses will examine patient characteristics, diagnostic testing patterns, in-hospital treatments, in-hospital outcomes, and variation in results across regions and hospitals. Practical guidelines, quality evaluative system, and risk model will be established based on the findings, to improve patient outcomes for HF in the future.

Eligibility Criteria:
Inclusion Criteria:

* Patients with heart failure as the primary reason for hospitalization, including both new-onset HF or decompensation of chronic HF。
* Hospitalized during January 1st, 2015 to December 31st, 2015
* Aged 18 years or above

Exclusion Criteria:

* None