cyrilzakka/clinical-trials huggingface dataset:
Can Dance Therapy Improve Motor Learning in Parkinson's Disease (PD)?

In order to find the most effective rehabilitative therapies for Parkinsonian patients, the present study is aimed to evaluate whether, in a multidisciplinary intensive rehabilitation treatment, the dance therapy, applied to the motor learning, promote additional benefits.


Eligibility Criteria:
Inclusion Criteria:

* Stage 2.5-3 according to the Hoehn and Yahr scale (H\&Y);
* Stable pharmacological treatment for the last 6 weeks before the enrolment and during the hospitalization;

Exclusion Criteria:

* Any focal brain lesion detected in brain imaging studies (CT or MRI) performed in the previous 12 months;
* Drug-induced dyskinesias;
* Disturbing resting and/or action tremor, corresponding to scores 2-4 in the specific items of UPDRS III;
* Behavioral disturbances (evaluated with Neuropsychiatric Inventory);
* Visual and auditory dysfunctions according to the general clinical evaluation and medical history;
* cognitive decline (MMSE correct score \< 24)
Effects of Topical Local Anesthesia of Pulmonary Vein Combined With Vagus Nerve Block on the Incidence of Atrial Fibrillation After Thoracic Surgery

This study intends to explore a new therapy to reduce the incidence of atrial fibrillation in thoracic patient who receive video-assisted thoracoscopic lobectomy .The results of the study are to assess the effects of this new intervention on the incidence，duration of atrial fibrillation and other complications including postoperative delirium after video-assisted thoracoscopic lobectomy .And reducing the burden of POAF on patients and their families, hospitals and public resources.


Eligibility Criteria:
Inclusion Criteria:

* Thoracoscopic lobectomy and bilobectomy
* ASA class I-III
* Age is greater than or equal to 50 years old
* Han Nationality, mother tongue is chinese
* The people signed informed consent

Exclusion Criteria:

* history of chronic atrial arrhythmia
* sick sinus syndrome
* history of second-degree atrioventricular block
* taking class I or class III antiarrhythmic drugs or β-receptor blocker
* history of radiofrequency ablation
* hyperthyroidism
* contraindications of ropivacaine, lidocaine
* pregnancy and lactation
CLN-418 Study on Subjects With Advanced Solid Tumors

Study to evaluate the safety and tolerability of the study drug CLN-418, to determine the maximum tolerated dose and/or recommended Phase 2 study dose of CLN-418.

This is a study to evaluate the safety and tolerability of the study drug CLN-418, and to determine the maximum tolerated dose and/or recommended Phase 2 study dose of CLN-418.

The study will also look at the anti-tumor activity, pharmacokinetics and immunogenicity of CLN-418.The study consists of 2 parts. In Part 1, patients are enrolled into different cohort doses in order to identify the appropriate recommended phase 2 dose (RP2D) or maximum tolerated dose (MTD). In Part 2, participants with metastatic / unresectable Non small cell lung cancer (NSCLC), Triple Negative Breast Cancer (TNBC) will receive the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) established in Part 1 of the study. In Part 1 and Part 2, participants will be administered treatment every 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Willingness to sign a written informed consent document.
2. Male or female subject aged ≥18 years old at the time of screening.
3. Histologically or cytologically confirmed advanced solid tumors (e.g., breast cancer, ovarian cancer, endometrial cancer, cervical cancer, squamous cell non-small cell lung cancer (sNSCLC), cholangiocarcinoma, esophagus cancer, urothelial carcinoma, head and neck squamous cell carcinoma (HNSCC)), followed by dose-expansion cohorts (Part 2) of subjects with advanced and/or metastatic non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC).or recurrent and progressed since last antitumor therapy for which no alternative, curative standard therapy exists.
4. Adequate organ and bone marrow function.

Exclusion Criteria:

1. Prior used anti-B7H4 and/or anti-4-1BB antibody treatment.
2. Immuno-oncology therapy or targeted anti-cancer therapy within 4 weeks prior to first dose of investigational product, any other anti-cancer therapy within 2 weeks prior to first dose of investigational product.
3. Not yet recovered from surgery or (immune-related) toxicity related with previous treatment.
4. Known history or active infection of hepatitis B or C.
5. History of cirrhosis or non-alcohol steatohepatitis, alcohol or drug-related, autoimmune hepatitis.
6. Known brain metastases or other central nervous system metastases that are either symptomatic or untreated that require concurrent treatment.
7. Active infection that requires treatment with antibiotics or antiviral treatment within 3 weeks prior to first dose of investigational product.
8. Known history of infection with human immunodeficiency virus or known acquired immunodeficiency syndrome (AIDS).
9. Known autoimmune disease.
10. Clinically significant cardiac condition.
11. Pregnant or breastfeeding women.
Primary Nasal Cell Culture as a Tool for Personalized Therapy in Cystic Fibrosis

characterization of CFTR function and expression in nasal primary cells collected from patients with cystic fibrosis in comparison to their parents, healthy heterozygotes and healthy controls

3 groups of subjects are enrolled CF subjects according to their genotypes (aiming to enroll patients carrying 2 CF causing mutations with no CFTR expression/function, and patients carrying at least 1 mutation with residual function, such R117H) Parents or siblings of the CF subjects, as healthy hétérozygotes healthy controls All these subjects experience nasal brushings. From these nasal brushings,nasal cells are expanded, and cultured in air liquid interface to obtain polarized epithelium. This epithelium is then studied in Ussing chamber experiments to characterize the level of cAMP dependant Chloride transport and Sodium reabsorption. Apical expression of CFTR is assessed by immunofluorescence.

Results will allow to define the variability of CFTR function and expression criteria in subjects with the same genotype. Such data are crucial for interpretation of the effect of CFTR modulators.

Eligibility Criteria:
Inclusion Criteria:

* patients with Cystic Fibrosis with 2 mutations in CFTR
* healthy heterozygotes with 1 mutation in CFTR
* healthy subjects with no familial history of Cystic Fibrosis and no symptoms suggesting Cystic Fibrosis

Exclusion Criteria:

* smoking
Effect of Autologous Peripheral Blood Stem Cell Treatment on Articular Cartilage Regeneration

The purpose of this study was to compare histologic and MRI evaluation of articular cartilage regeneration in patients with chondral lesions treated by arthroscopic subchondral drilling followed by postoperative intra-articular injections of hyaluronic acid (HA) with and without peripheral blood stem cells (PBSC)

The purpose of this study was to compare histologic and magnetic resonance imaging (MRI) evaluation of articular cartilage regeneration in patients with chondral lesions treated by arthroscopic subchondral drilling followed by postoperative intra-articular injections of hyaluronic acid (HA) with and without peripheral blood stem cells (PBSC)

Eligibility Criteria:
Inclusion Criteria:

* Patients who have signed informed consent form
* Patients with only unilateral isolated or multiple knee articular cartilage lesions demonstrated MRI scanning, with up to one previous operation on that knee
* Patients who are either male or female aged between 18 to 50 years old, corresponding to availability of normative International Knee Documentation Committee (IKDC) data.
* Female patients of childbearing age must have negative pregnancy tests and are advised to take contraceptive precautions throughout the study.

Exclusion Criteria:

* Patients with bilateral knee lesions
* Patients with the presence of ligamentous injury which would require reconstruction, varus or valgus deformity greater than 10 degrees, previous open total menisectomy requiring osteotomy, and cases that require complex surgery prior to cartilage regeneration
* Patients with significant cognitive impairment, non-ambulatory status or lower extremities amputation other than toes, serious illness or medication affecting operative risk or wound healing (e.g. steroid intake, anticoagulation), and poorly controlled diabetes mellitus with a baseline HbA1c more than 8
* Patients with significant peripheral vascular disease as indicated by absent dorsalis pedis or posterior tibial pulses.
* Patients who cannot read English will be excluded from the study as they will be unable to complete the study questionnaires in an objective manner
* Female patients who are pregnant
* Patients with any contradictions to MRI scanning
* Patients with body mass index (BMI) of over 35
Point-of-care EEG in the Pediatric Emergency Department

The researchers investigate the use of a simplified electroencephalogram (point-of-care EEG) in the pediatric emergency department for children with impaired consciousness or an ongoing epileptic seizure ("status epilepticus"). In addition, the researchers will compare the simplified EEG with the conventional EEG in the epilepsy outpatient clinic.

Non-traumatic, acute central nervous system (CNS) disorders are amongst the most frequent emergencies in childhood. In Switzerland, CNS disorders are the top ranking presentation of critically ill children. Many pediatric neurological emergencies such as coma, acute encephalopathies with impaired consciousness or agitation, or acute focal deficits, are associated with changes of cortical electrical activity detectable by the electroencephalogram (EEG). Of particular concern are status epilepticus (SE) and non-convulsive status epilepticus (NCSE). Previous studies have shown that an EEG can yield important diagnostic information and aid in decision-making. However, conventional EEG-recordings are resource intensive (time, staff), and hardly available outside of regular working hours. Point-of-care EEG (pocEEG) has proven helpful for evaluating impaired consciousness, detecting NCSE, and monitoring therapy in ongoing SE. In a retrospective cohort study from Japan patients with impaired consciousness were diagnosed with non-convulsive seizures in pocEEG, supporting the view that pocEEG can be applied by ED physicians, even in the absence of a neurologist, and can aid the detection and treatment of non-convulsive seizures. Another study, also from Japan, reported that abnormalities were detected in 20% of patients by using pocEEG in an ED setting. The aims of this study are:

* To prospectively assess the feasibility and utility of pocEEG for NCSE detection in children presenting with impaired consciousness in the PED
* To evaluate the interpretation accuracy of pocEEG by pediatric emergency medicine (PEM) providers after a teaching module.
* To compare pocEEG to the "gold standard" of simultaneously recorded conventional EEG in patients undergoing routine cEEG in the epilepsy outpatient clinics.

Eligibility Criteria:
Inclusion Criteria:

General:

PED:

* Pediatric patients with unexplained impaired consciousness, suspicion of NCSE, active SE presenting to the PED
* Informed consent of patient of parents/persons responsible, if possible, otherwise emergency situation procedure (according to national regulations for research in emergency situations)

CLINIC:

* Informed consent as documented by signature
* Pediatric patients undergoing cEEG in the outpatient epilepsy clinics
* Either suspected/ to rule out epilepsy or established diagnosis of epilepsy

Exclusion Criteria:

PED:

* AMS of known etiology or another diagnosis
* Declined informed consent

CLINIC:

* Failure to provide signed informed consent
* Changes in health condition which might interfere with the EEG recording.
Open Label Study of IV Brincidofovir in Adult Transplant Recipients With Adenovirus Viremia

This is a randomized, controlled, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetic (PK), and adenovirus (AdV) antiviral activity of multiple ascending doses of IV brincidofovir (BCV). Approximately 30 eligible subjects will be sequentially enrolled into 1 of 3 planned cohorts. Within each cohort, subjects will be randomized in a 4:1 ratio to receive IV BCV dosed twice weekly (BIW) (on Days 1, 4, 8, and 11) or to receive investigator-assigned standard of care (SoC).


Eligibility Criteria:
Inclusion Criteria:

* Be ≥ 18-years-old (or per local law or regulations on legal age of consent).
* Have received an allogeneic hematopoietic cell transplant (HCT) within the previous 100 days.
* Have plasma AdV DNA viremia ≥ 1,000 copies/mL (via quantitative polymerase chain reaction assay; local results must be confirmed by the designated central virology laboratory).

Exclusion Criteria:

* Diarrhea meeting the US National Institutes of Health (NIH)/National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater
* Acute graft versus host disease (GVHD)

  1. NIH Stage 2 or higher acute GVHD of the gut (i.e., diarrhea \> 1,000 mL/day, or severe abdominal pain with or without ileus) or liver (i.e., bilirubin \> 3 mg/dL : \> 51 μmol/L) within 7 days prior to Day 1
  2. Any NIH Stage 3 or Stage 4 acute GVHD within 7 days prior to Day 1
* Concurrent human immunodeficiency virus or active hepatitis B or C infection
* An estimated creatinine clearance of \< 30 mL/min, and/or use of renal replacement therapy within 7 days prior to Day 1.
* Poor clinical prognosis, including active malignancy, irreversible organ failure, use of vasopressors, requirement for mechanical ventilation, resting oxygen saturation \< 88%, or Pulmonary Arterial oxygen (PaO2) ≤ 55 mm Hg without supplemental oxygen at any time within 7 days prior to Day 1.
* Receiving or anticipated to start systemic cyclosporine immunosuppressant treatment during study participation.
* Received treatment with CDV within 14 days prior to Day 1.
* Previous receipt of cell-based anti-AdV therapy within 6 weeks prior to Day 1 or prior receipt of an anti-AdV vaccine at any time.
* Consumed food products containing sesame seeds, sesame oil, or dietary supplements containing sesamin within 3 days prior to Day 1.
* Received any investigational drug within 28 days prior to Day 1 or currently participating in another interventional study.
* Pregnant or breastfeeding.
High-definition Transcranial Electrical Stimulation for Lower Limb Stroke Rehabilitation

Transcranial electrical stimulation (tCES) is a non-invasive and safe treatment, which uses a low direct current or alternating current to change the excitability of the cerebral cortex. The tCES has been applied in clinical trials related to rehabilitation research in recent years, and the safety and effectiveness have also been established. However, the existing tCES products effect on the whole brain networks and lack special waveforms. We developed a wearable high-definition tCES (HD-tCES) with special waveforms. This novel stimulation system will result in more precise and focal stimulation of selected brain regions with special waveforms to display better neuromodulation performance. In this study, we will preliminarily examine the effects and safety of the HD-tCES on lower extremity in patients with stroke. We expect that the HD-tCES combined with the lower extremity rehabilitation can shorten the duration of rehabilitative periods, improve stroke patients' activity of daily living, reduce the care burden of patients' family, and subsequently decrease the cost of health care insurance.


Eligibility Criteria:
Inclusion Criteria:

1. With a diagnosis of stroke.
2. Age ≥ 20 years.
3. Hemiplegia, Brunnstrom stage III-V.
4. 6 months to 5 years after stroke.
5. Muscular inelasticity (spasticity) 1-3 on the affected lower limb, evaluated by the Modified Ashworth Scale.
6. Ability to walk for 10 min non-stop with no gait aids or ability to walk 20 m with supervision or slight assistance.

Exclusion Criteria:

1. Intolerance to electrical stimulation.
2. Contracture on lower extremities, and limitation in joint range of motion.
3. Severe spasticity.
4. Ossification or inflammation in muscle tissue.
5. A history of arrhythmia.
6. Implantable medical electronic devices (e.g., like pacemaker).
7. Metal implants in the head or neck.
8. Wounds on the skin of head.
9. A history of brain surgery or severe brain trauma.
10. Severe cognitive or psychiatric disorders (e.g., schizophrenia, depression or bipolar disorder).
11. A history of seizure or other brain pathology.
12. Drug or alcohol abuse.
13. Malignant neoplasm or rheumatism disorder (e.g., SLE, RA, AS, IBD)
14. Undergoing other non-invasive brain stimulation.
15. Intra-cerebral lesions (such as brain tumors, arteriovenous tumors).
16. History of encephalitis or meningitis.
17. Stroke lesion in cerebellum or brainstem.
18. Leg amputation.
19. Sleep deprivation.
20. Severe or recent heart disease.
21. Subjects who use drugs that may lower the seizure threshold.
22. Pregnant or breastfeeding women.
HealthySteps + PlayReadVIP

This study aims to investigate the effectiveness and implementation outcomes for the integration of two evidence-based practices and interventions (EBPIs) within pediatric primary care settings: HealthySteps (HS), which provides parenting support, and PlayReadVIP, which promotes relational health through video coaching. Families will be randomized to receive either the integrated HS + PlayReadVIP model or traditional HS, and investigators will examine impacts on parenting, parent-child relationships, and child development, as well as feasibility, acceptability, and appropriateness of the integrated intervention.


Eligibility Criteria:
Inclusion Criteria:

* Parent is a biological parent or legal guardian and at least 18 years of age
* Infants must be ≤6 months old at the time of enrollment.
* Parents/guardians must speak either English or Spanish to ensure they can fully engage with the intervention and assessments.
* Families must be identified as Tier 3 HealthySteps participants, indicating higher levels of need based on clinic screening for factors such as:Adverse Childhood Experiences (ACEs) and parenting challenges or vulnerabilities.
* Parent is able to willing to provide consent for their own and their child's participation.

Exclusion Criteria:

* Non-singleton child
* Parent is unable to provide consent
* Parent does not speak English or Spanish, as study materials (e.g., questionnaires) are available in those languages
* Parent has a severe medical or psychiatric impairment (e.g., intellectual disability, psychosis) that would interfere with study participation
* Parent has plans to discontinue care at NYU Langone Health - Sunset Park Family Health Centers
Effect of Docosa-Hexanoic Acid (DHA) Supplements During Pregnancy on Newborn Outcomes in India.

The 'DHANI randomized controlled trial" seeks to examine the effects of prenatal DHA supplementation on newborn anthropometry where in healthy pregnant will be assigned to receive either 400 mg of DHA or a placebo daily from ≤20 weeks gestation through delivery.

A double-blinded, randomized, placebo controlled trial would be conducted among pregnant women in India to test the effectiveness of supplementing pregnant Indian women with 400 mg/d algal DHA compared to placebo from mid-pregnancy through delivery. Eligible participants would be randomized to receive either 400 mg of DHA or a placebo baseline measures would be taken before the enrollment of the participant in the study. This study would assess the effect of maternal DHA supplementation on:

1. New born anthropometry (birth weight, length and head circumference)
2. New born APGAR score

Eligibility Criteria:
Inclusion Criteria:

* 18 to 35 year old pregnant women (singleton) at \<=20 weeks of gestation (calculated from the LMP by study physician).
* Willing to participate in the study and perform all measurements for self, husband and the offspring including anthropometry, dietary assessment, questionnaires and biological samples (blood and breast milk).
* Willing to provide signed and dated informed consent.

Exclusion Criteria:

* Women allergic (if aware) to any of the test products.
* Women at high risk for hemorrhagic bleeding, clotting (if aware).
* Women with high-risk pregnancies (history and prevalence of pregnancy complications, including abruptio placentae, preeclampsia, pregnancy-induced hypertension, any serious bleeding episode in the current pregnancy, and/ or physician referral); and/or diagnosed chronic degenerative disease(s) such as diagnosed heart disease, cancer, stroke or diabetes (as omega-3 could raise blood sugar and lower insulin production).
* Women consuming omega-3 supplements or having used these in 3 months preceding the intervention period.
* Reported participation in another biomedical trial 3 months before the start of the study or during the study (not to get the results of the present study contaminated).
Effect of Photodymamic Therapy With Urucum and LED in the Reduction of Halitosis

Halitosis, also known as bad breath, is a term used to define an unpleasant and foul odor that emanates from the mouth and may have local or systemic origin. This project aims to observe the presence of halitosis and to verify if the treatment with antimicrobial photodynamic therapy (aPDT) is effective against it. The investigators will select 45 students or UNINOVE employees, from 18 to 25 years old, with a diagnosis of halitosis, presenting sulfite (SH2) ≥ 112 ppb on gas chromatography. Patients will be randomly divided into 3 groups of 15, which will receive different treatments: Group 1: treatment with tongue scraper; Group 2: aPDT applied in the back region and middle third of the tongue; Group 3: combined treatment of tongue scraper and aPDT. For the aPDT we will use urucum manipulated in the concentration of 20% (Fórmula e Ação®) in spray, to be applied in sufficient quantity to cover the middle third and back of the tongue (5 sprinkles) for 5 minutes for incubation, associated with a LED (Valo Cordless Ultradent®). 6 points will be irradiated on the back of the tongue with a distance of 1 cm between the points, considering the halo of light scattering and effectiveness of aPDT. The apparatus shall be precalibrated at wavelength 440-480nm for 60 seconds per point, irradiance of 450mW/cm and the light shall be irradiated so that a halo of 2cm diameter is formed per point. The results of the halimetry will be compared before and immediately after the treatment, besides the microbiological analysis of the tongue coating, before and after the treatment. The normality of the data will be measured using the Shapiro-Wilk test, and in the case of normality the Variance Analysis (ANOVA) test will be applied, and in the case of non-parametric data, the Kruskal-Wallis test will be used. To analyze the results of each treatment in both periods of the study, the Wilcoxon test will be used.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 25 years;
* Sulphide (SH2) ≥ 112 ppb in the gas chromatography.

Exclusion Criteria:

* Dentofacial anomalies (such as cleft lip and cleft palate);
* Undergoing orthodontic and/or orthopedic treatment;
* Undergoing oncological treatment;
* Systemic alterations (gastrointestinal, renal, hepatic);
* Treatment with antibiotics up to 1 month before the survey;
* Pregnant.