cyrilzakka/clinical-trials huggingface dataset:
Effect of Noninvasive Brain Stimulation on Hypokinetic Dysarthria in Parkinson's Disease

Hypokinetic dysarthria (HD) is common in Parkinson's disease (PD) patients and responds only partially to pharmacotherapy and surgery. The investigators will explore long-term effects of repetitive transcranial magnetic stimulation (rTMS) applied over right superior temporal gyrus, brain area known to be engaged in the feedback control of voiced speech. The project results will allow for the identification of potential therapeutic effects of rTMS as a tool that could contribute to the speech therapy of HD in PD patients. The results will also enhance our understanding of brain mechanisms underlying specific long-term effects of rTMS.

A two parallel group, randomized, placebo controlled design will be used. Twenty PD patients will be stimulated in a two weeks long therapeutical sessions (10 sessions). Other twenty PD patients will be stimulated with the same protocol using sham stimulation. An MRI protocol consisting of T1, EPI BOLD, and DTI (diffusion tensor imaging) sequences and speech evaluation (acoustic signal processing and 3F test) will be performed prior to and after 10 days of rTMS and then repeated after 4, 8 and 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* patients with clinically established PD (Postuma et al. 2016)

Exclusion Criteria:

* psychiatric disorders, including major depression, hallucinations
* any MRI-incompatible metal in the body
* epilepsy
* lack of cooperation
* presence of dementia
Laser Treatment for Lichen Sclerosus

Fractional ablative laser treatment for Lichen Sclerosus lesion


Eligibility Criteria:
Inclusion Criteria:

* Female aged 18 years or older
* Biopsy-proven vulvar lichen sclerosus lesion
* Experiencing one or more of the following symptoms of LS:

  1. Dryness
  2. Itching
  3. Burning
  4. Bleeding
  5. Blistering
  6. Soreness
  7. Easily bruises
  8. Easily tears
  9. Ulcerated lesions
  10. Painful intercourse
* Negative urine pregnancy test if subject is of childbearing potential before enrollment
* Absence of vulvovaginal infection i.e. fungi, bacterial vaginosis, and STI
* Ability to understand and sign informed consent, questionnaires, and all investigation requirements
* Willing to consent to clinical photographs of the treatment area
* Willing to consent to ultrasound images of the treatment area
* Willing and able to logistically follow schedule of treatments and follow-up visits

Exclusion Criteria:

* Pregnancy, less than 3 months postpartum, or planning to become pregnant during the investigation to protect integrity of the data
* Is a nursing mother
* History of uncontrolled malignant disease
* Active urogenital infection or chronic infection (i.e., candida, herpes, herpes simplex, bacterial vaginosis, trichomoniasis, or other infection)
* Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich syndrome)
* Subjects with genital skin disease, psoriasis due to risk of koeberizing
* Subjects on immunosuppressants: mycophenolate, retinoids, azathioprine, cyclosporin
* Known allergy or intolerance to local anesthesia
* Known history of connective tissue disease
* Known propensity for keloid formations
* Known medical condition that may affect wound healing
* Any reason that the investigator deems prohibits participation in the investigation
Tolerance and Efficiency of an Intrabuccal Biological Film to Enhance Oral Dryness Sensation: The "PREDELFI" Clinical Pilot Study

Xerostomia affects at least a quarter of the population. This prevalence is increased in postmenopausal women and people over 65 years of age. Associated with age are systemic diseases such as Sjögren's Syndrome, diabetes, Parkinson's disease or cancer. It handicaps the patient in his social life, but also in terms of his well-being by the consequences it generates in the oral cavity. This dryness may be the consequence of taking certain medications, head and neck radiotherapy, but also being a symptom of an underlying pathology whose screening will allow early treatment and avoid complications. Today, no single therapeutic solution is enough and patients are waiting for new therapeutic innovations in this area. This study proposes to evaluate the tolerance of an adhesive film containing prebiotics by comparing it to a placebo control film.

The purpose of this study is to evaluate the tolerance of an adhesive film containing prebiotics on the improvement of signs and symptoms related to dry mouth by comparing it to a placebo film.

The primary endpoint is the assessment of tolerability assessed using a visual analogue scale (VAS) from 0 to 100 at the end of the 1-month period of both treatment periods (D30 and D90). In this study, the efficacy and tolerance of the adhesive film containing prebiotics will be analyzed.

Each participant in this study will receive two galenic forms of the medical device whose allocation order was previously defined by a randomization list.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 or over
* Complaining of xerostomia and validated by a standardized question
* With hyposialia diagnosed by the measurement of stimulated salivary flow (DSS) and unstimulated (DNS)
* Patient having signed a consent
* Registered with Social Security

Exclusion Criteria:

* The patient having known sensitivity to any of the products or components of the biofilms (milk protein, soy derivatives, sodium alginate, vegetable glycerin, caramel and beta carotene)
* Allergic to birch and / or peanut
* Having an ethyl intoxication (\> 2 glasses of wine / day), smoking (\> 10 cigarettes / day)
* Unable to complete self-assessment questionnaires or to follow study protocol procedures (unable to read and / or write).
* Participant in another clinical study at the time of inclusion or having participated in the 30 days preceding recruitment in this study
* Having a life-threatening condition for the duration of the study
* Treated with sialogogues (pilocarpine hydrochloride) within 30 days prior to inclusion
* Using salivary substitutes
* Protected persons within the law (articles L1121-5 to L1121-8)
Technology-based Analysis of Movement Disorders

Objectives: To generate pilot data to investigate the feasibility and the potential use in clinical practice of technology based objective measures of motor performances in patients affected by different movement disorders. To correlate kinematics findings with demographic and clinical details. Trial design and methods: Participants enrolled in prof. Bhatia's movement disorders clinic, will be classifies according to the main movement disorder, specifically, tremor, parkinsonism, dystonia, chorea, ataxia. In the study visit (one day only), they will undergo a clinical evaluation using the appropriate clinical scales (respectively, Fahn-Tolosa-Marin tremor rating scale, MDS-UPDRS Part III, Toronto Western Spasmodic Torticollis Rating Scale 2, Unified Hungtington Disease Rating scale and Scale for the Assessment and Rating of Ataxia) and a kinematic evaluation, using wearables and an infra-red and LED markers system. Then the protocol is concluded and they will continue the routine clinical follow-up


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of parkinsonism and/or dystonia and/or tremor due to:

  1. idiopatic parkinson's disease
  2. atypical parkinsonism
  3. sporadic or inherited/genetic dystonia
  4. young-onset Parkinson's disease
  5. Ataxia syndrome
  6. Choereic syndrome
  7. Essential tremor
  8. Dystonic tremor
* 18 to 80 years of age
* Willing and able to provide informed consent
* able to walk unassisted

Exclusion Criteria:

* Change in pharmacological therapy in the last 3 months.
* Participated in a clinical drug trial up to 3 months before inclusion into the present study
* Orthopaedical comorbidities affecting gait or posture.
* Cognitive deficit
A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus Infection

The purpose of this study was to evaluate the safety and efficacy of entecavir in pediatric patients with chronic hepatitis B virus infection


Eligibility Criteria:
Key Inclusion Criteria

* Males and females, aged 2 to \<18 years
* Hepatitis B surface antigen-positive
* Detectable hepatitis B e (HBe) antigen, and no detectable anti-HBe antibodies
* Alanine aminotransferase (ALT) 1.5 to \<10 times the upper limit of normal at screening and within 8 to 24 weeks prior to screening
* Evidence of the presence of hepatitis B virus DNA at least 4 weeks before screening and \>100,000 copies/mL at screening

Key Exclusion Criteria

* Any prior therapy with entecavir
* At least 12 weeks of prior therapy with any nucleoside or nucleotide antiviral agent
* Therapy with interferon alpha, thymosin alpha, or nucleototide antiviral agents within 24 weeks of screening
* Coinfection with HIV, hepatitis C virus, or hepatitis D virus
* Decompensated liver disease
* Liver transplant recipients
* Other forms of acute and chronic conditions which may cause increased ALT levels
* Children who were breastfed while their mothers received lamivudine or whose mothers received lamivudine during pregnancy
Cancer Genome Study Using Samples From Patients Treated on Clinical Trial SHR1020-SHR-1210-II-OS

RATIONALE: Studying samples of tumor tissue from patients with advanced osteosarcoma refractory to chemotherapy in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to osteosarcma treatment combining anti-angiogenesis tyrosine kinase inhibitors and anti-PD-1 antibody.

PURPOSE: This research study is looking at the cancer genome using tumor samples from patients with advanced stage osteosarcoma treated on clinical trial SHR1020-SHR-1210-II-OS.

OBJECTIVES:

To investigate the clinical relevance of conducting comprehensive molecular analyses on clinically annotated high-quality tumor specimens from patients with advanced stage osteosarcoma.

OUTLINE: This is a single-center study.

Biological specimens are collected from participating clinical site and analyzed by transcription profiling of RNA and microRNA; detection of DNA copy number changes and chromosomal rearrangements; epigenetic modifications analyses; and sequencing of genomic segments, genes, and regulatory regions to assess sequence variation. Clinical information associated with each specimen donor is also collected.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of high-grade osteosarcoma
* refractory to chemotherapy and intended to receive famitinib and camrelizumab following the protocols of SHR1020-SHR-1210-II-OS
* Available tumor tissue samples collected before study drug and after first progression
* Must have matching frozen samples of normal tissue and blood

Exclusion Criteria:

* Patients with concurrent malignancy; patients with prior or concurrent malignancy will be allowed as long as the treating physician considers it unlikely to impact the clinical outcome of the patient
* Serious medical illness including but not limited to uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction or cerebrovascular event with 6 months of registration, history of chronic active hepatitis or history of human immunodeficiency virus (HIV) or an active bacterial infection will not be eligible
* Pregnant or lactating women
Ventilator Asynchrony as a Predictor of Weaning Failure

Patient ventilator asynchrony is a common problem in mechanically ventilated patients .It is associated with adverse effects including increased work of breathing, patient discomfort, increased need for sedation, prolonged mechanical ventilation , weaning difficulties and weaning failure. 100 mechanically ventilated COPD patients were enrolled in this prospective study .Detection of patient ventilator asynchrony was done on 30-minute sessions at 12, 24, 36, and 48 hours following intubation by visual assessment of pressure, flow and volume graphs on ventilator .

Patient-ventilator asynchrony is defined as a lack of organization between the patient and ventilator timing of both inspiration and expiration . It is a commonly reported problem during mechanical ventilation. Thille et al. found that 24% of patients developed asynchrony in at least ten percent of their breaths, moreover they stated that the most frequent asynchronies was each of ineffective triggering and double triggering . Eighty percent of chronic obstructive pulmonary disease (COPD) patients experienced ineffective triggering, where it is considered the most frequent asynchrony in this group of patients. Asynchrony between Patient and ventilator also leads to prolonged duration of invasive ventilation, and increase possibility of weaning failure.

Both spread and intensity of asynchrony during the early phase of weaning in COPD patients has never satisfactorily described. The aim of the current study was to describe the patient-ventilator asynchrony and its impact on weaning outcome in mechanically ventilated COPD patients.

Eligibility Criteria:
Inclusion Criteria:

All COPD patients who were diagnosed after history ,physical examination radiology and pulmonary function tests and required mechanical ventilation.

Exclusion Criteria:

1. Age \< 18 years
2. Tracheostomy
3. Failure to trigger breaths even in cases of receiving neuromuscular blocking agents.
4. Encephalopathy which is not caused by hypercapnia or hypoxemia either post arrest or due to cerebrovascular stroke
5. Patients with unplanned weaning
6. COPD patients where intubation not related to exacerbation e.g. acute pulmonary edema.

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Effects of Beer (Alcohol) on Social Cognition

The present study aims to evaluate effects of beer (alcohol) on social cognition.

Alcohol is one of the most widely used recreational drugs and it is often used in social settings to enhance sociability. There are few data showing that acute alcohol consumption affects facial emotion recognition. However the acute effects of alcohol in social drinkers on different aspects of social cognition are largely unknown. In the present study, we will therefore evaluate effects of beer (alcohol) on social cognition. The study will include 60 subjects (30 male, 30 female) and use a placebo-controlled, crossover design with the two experimental conditions alcoholic beer (individually calculated amount aiming to achieve a blood-alcohol concentration of 0.4g/kg), and non-alcoholic beer (placebo). We primarily aim to evaluate whether beer (alcohol) affects the ability to correctly decode emotions in facial expressions using different facial emotion recognition Tasks. Additionally, appraisal of visual erotic stimuli following alcohol consumption will be evaluated. Subjective social and mood effects will be assessed using validated questionnaires. Blood samples will be collected to assess plasma levels of the "social hormone" oxytocin as well as blood alcohol levels to test possible associations with effects on emotional processing.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 50 years
2. Sufficient understanding of the German language
3. Subjects understand the procedures and the risks associated with the study
4. Participants must be willing to adhere to the protocol and sign the consent form
5. Participants must be willing to refrain from drinking alcohol in the evening preceding the study session
6. Participants must be willing to abstain from excessive drinking and from taking illicit psychoactive drugs during the study.
7. Participants must be willing not to eat or drink xanthine-containing liquids (such as coffee, black or green tea, red bull, chocolate) 3 h prior to the study session
8. Participants must be willing not to drive a traffic vehicle or to operate machines for 3h after the sessions
9. Women must have a negative pregnancy test at the beginning of each session.

Exclusion Criteria:

1. Chronic or acute medical condition.
2. Current or previous personal history of psychotic or major affective disorder.
3. Prior or current alcohol abuse, dangerous drinking behavior (\>15 points in the AUDIT questionnaire).
4. Family history of alcoholism (first-degree relative).
5. Alcohol hypersensitivity
6. Prior illicit drug use (except Tetrahydrocannabinol (THC)-containing products) more than 15 times or any time within the previous week.
7. Use of medications that are contraindicated or interfere otherwise with the effects of the study (monoamine oxidase inhibitors, antidepressants, sedatives etc.)
8. Pregnant or nursing women.
9. Participation in another clinical trial (currently or within the last 30 days).
FBnTP Imaging of Breast Cancer

Our preclinical studies suggest the capacity of the positron emission tomography imaging agent 18F-fluorobenzyl triphenyl phosphonium (FBnTP) to detects early-stage small breast tumors (e.g., DCIS), and differentiates benign from malignant masses with better accuracy than that obtained by existing breast imaging tools.

Breast cancer is the most widespread type of cancer among women in the USA, and the second leading cause of death. The National Cancer Institute estimates that in 2013, in the USA, 226,870 women will be diagnosed with breast cancer and 39,510 women will die of breast cancer, most of them of progressive metastatic disease. Early detection and treatment of the disease, when the tumor is still localized and at a high curability state, is the outmost important determinant of disease-free survival of breast cancer patients. Survival rate of women first diagnosed with pure early-stage noninvasive tumor (ductal carcinoma in situ- DCIS) is nearly 98%, which drops to 48% in patients with advanced disease.Yet, early detection of breast cancer is relatively poor. This is best exemplify by the astonishing percentage of benign biopsies; 80% of 1.7 million biopsies in the USA, at a cost of $3 billion; whereas, only small fraction (\~20%) of newly diagnosed women are found to have pure DCIS.

Our preclinical studies suggest the capacity of the positron emission tomography (PET) imaging agent 18F-fluorobenzyl triphenyl phosphonium (FBnTP) to detects early-stage small breast tumors (e.g., DCIS), and differentiates benign from malignant masses with better accuracy than that obtained by existing breast imaging tools. Accordingly, the present protocol is designed to extend the preclinical findings into clinical studies in breast cancer women, and to assess the effectiveness of 18F-FBnTP in detecting breast malignant lesions, in comparison with magnetic resonance imaging and fluorodeoxyglucose PET imaging.

Eligibility Criteria:
Inclusion Criteria:

* Female patients with newly-diagnosed invasive and/or intraductal breast cancer detected by core needle or vacuum-assisted biopsy (i.e., index cancer)
* Age \> 25 Ability and willingness to sign informed consent prior to any study procedure.
* Positive indication of disease on mammogram or MRI scan.
* Candidate for breast cancer surgery on the basis of recommendation of a breast cancer surgeon.
* Ability to undergo up to 90 minutes of PEM imaging.

Exclusion Criteria:

* Any active or chronic illness that, in the opinion of the investigators, would make the study unsafe or limit compliance with study procedures.
* Past or present history of active substance abuse (drug or alcohol).
* Inability to tolerate venous access.
* Pregnant females are excluded from this study. All females of child-bearing potential will undergo a serum pregnancy test within 48 hours prior to FBnTP administration.
Anaerobic Power and Salbutamol

Athletes using inhaled β2-adrenoreceptor agonists (IBAs) win a disproportionate number of medals. However, most previous research has shown that β2 agonists do not improve exercise performance in either asthmatic or non-asthmatic athletes. Although the majority of these studies do not show an ergogenic effect, the small number of studies with extended exercise bouts (\~60 minutes) do show an advantage. The investigators believe that a controlled yet sport-specific exercise protocol will elucidate this ergogenic effect. Because IBAs may have different effects on these two groups of athletes, the investigators will measure exercise performance in both female and male elite cyclists. The investigators hypothesize that athletes will perform better during a combination steady-state/sprint exercise task following salbutamol administration.


Eligibility Criteria:
Inclusion Criteria:

* maximal oxygen consumption of ≥60 and ≥55 mL⋅kg-1⋅min-1 or ≥5⋅L⋅min-1 and ≥4⋅L⋅min-1 for men and women

Exclusion Criteria:

* pregnant women
* any history of uncontrolled respiratory or cardiac disease
* smokers
* diabetics
Study to Assess Pharmacokinetics, Safety, and Tolerability of MT-7117 in Subjects With Normal and Impaired Hepatic Function

An Open-label, Single-center, Parallel-group Study to Assess Pharmacokinetics, Safety, and Tolerability of a Single Dose of MT-7117 in Subjects with Normal and Impaired Hepatic Function


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 18 to 75 years of age inclusive
* BMI 18 -35 kg/m2
* If female, you are nonpregnant, non-lactating and willing to utilize approved methods of birth control.

Exclusion Criteria:

* Subjects who have mild or moderate hepatic impairment according to Child-Pugh classification system at Screening (except normal healthy matches)
* Subjects who have a known clinically significant (CS) hypersensitivity to MT-7117 or related compounds, including melatonin.
* Subjects who have previously participated in a study involving MT-7117 or taken any other investigational drug within 30 days or 5 half-lives prior to the first dose of IMP, whichever is longer.
* Subjects who have a CS or unstable neurological, renal, cardiovascular, gastrointestinal, pulmonary, or hematologic disease for 14 days prior to enrollment.
* Subjects who have used any prescription or over-the-counter (OTC) medication within 14 days prior to first dose of IMP, except for occasional use of acetaminophen (\< 1 g/day for normal hepatic subjects, and \< 2 g/day for hepatically impaired subjects) or any other medication approved by the sponsor (a case-by-case basis). For hepatic impaired subjects, prescribed medication or OTC may be permitted by the Investigator and sponsor on a case-by-case basis.
Endovenous Radiofrequency Ablation Closure System in the Treatment of Varicose Veins

The goal of this clinical trial is to evaluate the effectiveness and safety of the endovenous radiofrequency ablation closure system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. for the treatment of varicose veins.

In this prospective, multi-center, randomized controlled study, 176 patients who were diagnosed with varicose veins and met the inclusion criteria without any exclusion criteria were randomly divided into the experimental group (Hongyuan Endovenous Radiofrequency Ablation Closure System)and control group (Medtronic's ClosureFast™ Radiofrequency Ablation System) at 1:1. The effectiveness of the product was evaluated by the vascular closure rate at 6 months after the operation, and the safety of the product was evaluated by the incidence of adverse events and serious adverse events within 6 months after the operation.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 years old, no gender limit.
2. Great saphenous varicose, CEAP grade C2-C6.
3. The diameter of the diseased vein is ≥2mm, ≤15mm.
4. Expected survival period ≥ 6 months.
5. The informed consent form can be signed by the patient or the legal representative.

Exclusion Criteria:

1. Are pregnant or breastfeeding.
2. Participating in clinical trials of other devices or drugs.
3. Deep vein thrombosis in the affected limb.
4. Uncorrectable coagulation dysfunction and obvious abnormal blood picture, with obvious bleeding tendency (platelets≤30x109/L).
5. Acute thrombosis in the main saphenous vein of the affected limb.
6. The investigator judged that it is not suitable to participate in the clinical trial.