cyrilzakka/clinical-trials huggingface dataset:
Virtual Reality in Motor Performance and Quality of Life in Patients With Parkinson's Disease

Treatment with Nintendo wii is higher to physical therapy conventional in the quality of life and motor performance in patients with Parkinson's disease.

The aim of this study is to assess if the treatment of rehabilitation with Nintendo wii is higher to the conventional in the quality of life and motor performance in patients with Parkinson's disease.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Parkinson's disease
* Both the sex with age between 50 and 80 years
* To be in it I serve as apprentice of 1 the 3,0 in the scale of Hoehn Yahr

Exclusion Criteria:

* Cognitive impairment
* Poorly controlled arterial hypertension
* Poorly controlled Cardiopathy
A PET Study With RO5545965 in Healthy Male Volunteers

This single center, open-label study will evaluate the PK-PDE10A Enzyme Occupancy Relationship of RO5545965 after a single dose in healthy male volunteers by positron emission tomography (PET).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects, 25 to 50 years of age, inclusive; healthy status is defined by absence of evidence of any active or chronic disease
* Body mass index (BMI) 18 to 30 kg/m2 inclusive
* Male subjects with female partners of child-bearing potential must use two methods of contraception, one of which must be a barrier method (i.e. condom), for the duration of the study and for 30 days after the last dose

Exclusion Criteria:

* History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, haematological or allergic disease, metabolic disorder, cancer or cirrhosis
* History of clinically significant hypersensitivity or allergic drug reactions
* Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse
* Regular smoker (\> 5 cigarettes, \> 1 pipeful or \> 1 cigar per day)
* Positive for hepatitis B, hepatitis C, or HIV infection
* Evidence of significant cardiovascular disease or disorder
* Participation in an investigational drug or device study within 3 months prior to first administration of the study drug or within 6 times the elimination half-life, whichever is longer
* Previous inclusion in a research and/or medical protocol or any clinical procedures involving nuclear medicine, PET, occupational exposure to ionizing radiation or radiological investigations with significant exposure to radiation, excluding dental X-ray and common X-rays of chest or extremities
* Subject has any condition that would prevent an MRI from accurately or safely being performed \[eg, claustrophobia, cardiac pacemaker, metallic implants or clips\]
* Subject unable to lie on his back in the PET or MRI scanner for a period of 90 minutes
* Contraindication for arterial cannulation
* Unsuitable veins for repeated venipuncture
Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH

The main goal of this study is to determine the effects of combination medical therapy (Riociguat and Macitentan) and balloon pulmonary angioplasty (BPA) on hemodynamics and right ventricular (RV) function (including advanced assessments of RV-pulmonary artery (PA) coupling from invasive hemodynamics) in participants with inoperable or post-PTE residual CTEPH.

Recent presented but unpublished results from trials of BPA vs riociguat for inoperable CTEPH (NCT02634203) have demonstrated that BPA provides a more significant hemodynamic benefit than medical therapy. The investigators hypothesize that participants who are treated with upfront combination medical therapy followed by BPA will have significant improvements in their hemodynamics and RV-PA coupling that can be monitored over time.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

1. Age ≥ 18 years' old
2. Diagnosis of CTEPH
3. Not a candidate for PTE
4. Candidate for BPA based on suitable anatomy and disease burden
5. Treatment-naïve (no CTEPH or pulmonary arterial hypertension (PAH)-specific medical therapies) with plans for initiation of CTEPH/PAH-specific medical therapy and treatment with BPA.
6. Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed).

Exclusion Criteria:

* Subjects presenting with any of the following will not be included in the trials:

  1. Moderate to severe heart disease (LVEF \< 45% or severe LV Hypertrophy)
  2. Sarcoidosis
  3. Active cancer
  4. Sickle cell anemia
  5. Liver disease (Childs-Pugh class C)
  6. Prisoners
  7. Pregnant, planning pregnancy or lactating
  8. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
  9. Contraindication to riociguat or macitentan
  10. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab) and Xeloda (Capecitabine) in Patients With HER2-Positive Breast Cancer

This single arm study will assess the efficacy and safety of Avastin in combination with Herceptin and Xeloda as first-line treatment of patients with HER2-positive locally recurrent or metastatic breast cancer. Patients will receive 3-weekly treatment cycles of Herceptin (8mg/kg iv on day 1 of first cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles), Xeloda (1000mg/m2 bid po on days 1-14 of each treatment cycle) and Avastin (15mg/kg on day 2 of first treatment cycle,and on day 1 of each subsequent cycle).The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* breast cancer with measurable locally recurrent or metastatic lesions;
* candidate for chemotherapy;
* HER2-positive disease;
* ECOG PS of \<=2.

Exclusion Criteria:

* previous anticancer therapy for metastatic breast cancer;
* previous radiotherapy for metastatic breast cancer (except for adjuvant radiotherapy \>=6 months before enrollment);
* chronic daily treatment with corticosteroids (\>=10mg/day), aspirin (\>325 mg/day) or clopidogrel (\>75mg/day);
* other primary tumor within last 5 years, except for adequately treated cervical cancer in situ, squamous or basal cell skin cancer;
* uncontrolled hypertension or significant cardiovascular disease.
Acute Effects of a Heat-not-burn Tobacco Product on Pulmonary Function

Background: IQOS ("I-Quit-Ordinary-Smoking,") is a type of the growing class of "heat-not-burn" (HNB) tobacco products. The effect of the acute exposure to IQOS smoke on the pulmonary function of healthy smokers has not been studied extensively.

Objectives: Evaluation of the acute effects of IQOS on pulmonary function.

Methods: Healthy non symptomatic smokers, underwent exhaled CO measurement, spirometry including flows, volumes and diffusion capacity, and measurement of their respiratory resistances at 5, 10 and 20 Hz (R5Hz, R10Hz and R20Hz) with the use of an impulse oscillometry system (IOS) before and 15 min after the use of an IQOS.

All participants underwent pulmonary function tests (PFT) (MasterScreen PFT, Jaeger, Wurzburg, Germany) and total respiratory resistances measurement with an impulse oscillometry system (IOS)( (Viasys Jaeger MasterScreen IOS system).From the basic pulmonary measurements (flows and dynamic lung volumes), Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), Tiffenau index (FEV1/FVC, FEV1%), Peak Expiratory Flow (PEF), Maximal Expiratory Flow (MEF) at 25%, 50%, and 75% of vital capacity, Functional Residual Capacity (FRC), Total Lung Capacity (TLC), Residual Volume (RV), Diffusion Capacity (DLCO) were measured. Each manoeuvre was repeated for at least three technically acceptable forced expiratory flow curves in order to attain the best results. Respiratory impedance at 5 Hz (Z5Hz) and respiratory resistance at 5, 10, and 20 Hz (R5Hz, R10Hz, and R20Hz, respectively), reactance at 5, 10, and 20 Hz and resonant frequency were assessed with IOS.

After smoking heated tobacco (IQOS): 5 minutes after smoking IQOS , they repeated again PFTs and IOS measurements.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy smokers,
2. \>10 pack/years
3. receiving no medications
4. no co morbidity

Exclusion Criteria:

1. aged \<18 years
2. pregnant
3. receiving any medications
4. any co morbidity
Ranibizumab Therapy for Choroidal Neovascularization (CNV) Asociated With Angioid Streaks

The purpose of this study is to determine whether injections of ranibizumab into the eye are safe and well tolerated when given to subjects in multiple doses.

Choroidal neovascularization is a hallmark of angioid streaks, and presumably VEGF-driven. Ranibizumab has been shown to be effective in CNV secondary to age-related macular degeneration. Therefore, we hypothesize that ranibizumab may be efficacious in the treatment of CNV secondary to angioid streaks

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 18 years
* Angioid streaks
* Subfoveal CNV of recent onset with the following characteristics
* Absence of subfoveal fibrosis
* Fibrosis less than 25% of the lesion
* Presence of blood, subretinal fluid, and/or lipid
* New onset symptoms within 12 weeks
* Visual acuity 20/40 to 20/800 on an ETDRS chart

Exclusion Criteria:

* Prior treatment of subfoveal CNV in the study eye
* Age-related macular degeneration
* Uncontrolled glaucoma
* High myopia (\> -10.00 D spherical equivalent)
* Prior retinal detachment
* Media opacity preventing adequate view of the retina
* Planned cataract surgery in the next 3 months
* Current chemotherapy for cancer
* Immunocompromised state
* Pregnancy (positive pregnancy test) or lactation
* Premenopausal women not using adequate contraception.
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Participation in another simultaneous medical investigation or trial
* History of any previous treatment for angioid streaks
Determining Clinical Trial Experiences of Lung Cancer Patients

Participation in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This trial will admit a wide range of data on the clinical trial experience of lung cancer patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future lung cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been diagnosed with lung cancer
* Patient has self-identified as planning to enroll in an observational clinical trial
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Pregnant or nursing patients
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form
Pain Evaluation in Radium-223 Treated Castration Resistant Prostate Cancer Patients With Bone Metastases

This observational prospective single arm cohort study is designed to assess pain and bone pain related quality of life of metastatic Castration Resistant Prostate Cancer (mCRPC) patients receiving Radium-223 in a real life nuclear medicine practice setting. In addition, overall survival, time to next tumor treatment (TTNT), time to first symptomatic skeletal event (SSE), course of blood counts, and safety will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Adult male patients diagnosed with CRPC with symptomatic bone metastases without known visceral metastases
* Decision to initiate treatment with Radium-223 was made as per investigator's routine treatment practice

Exclusion Criteria:

* Patients participating in an investigational program with interventions outside of routine clinical practice or participating in another observational study with Xofigo
Seasonal Affective Disorder and Visual Impairment

As a subtype of major depressive disorder, seasonal affective disorder (SAD) or winter depression causes severe reductions in both quality of life and productivity and results in high morbidity and frequent sick leave (1). SAD is a prevalent disorder with rates as high as 3-5% in central European countries and 8-10% in Scandinavian countries. In our recent screening survey among persons with severe visual impairment or blindness (visual acuity \< 6/60), we found a strikingly high prevalence of SAD of 17 % compared to 8% in the fully sighted control group. Persons with maintained light perception had a highly increased SAD prevalence of 18 % whereas no light perception (NLP) respondents had an SAD prevalence of 13 %. Light is unquestionably of great importance in the development and treatment of SAD. It is suggested that a reduced retinal sensitivity to light leads to sub-threshold light input to the brain and consequently to the development of SAD. The novel retinal non-visual photoreceptors, the intrinsically photosensitive retinal ganglion cells (ipRGCs), are involved in the regulation of circadian rhythm and mood and their function are in part independent of the function of the classical rod and cone photoreceptors which form the basis of conscious visual perception. Function of the ipRGCs can be assessed by chromatic pupillometry where the sustained pupillary contractions following blue light stimulation (PIPR) is the main outcome. In persons with SAD without eye disorder the function of the ipRGCs is reduced. We here wish to investigate associations between ipRGC function and SAD symptoms, circadian profile and treatment response to light therapy in persons with visual impairment.

Persons with visual impairment (SAD and non-SAD) are assessed for ipRGC function with chromatic pupillometry, for seasonal mood variation by interview and questionnaire and for diurnal melatonin secretion by saliva analysis summer and winter. In winter SAD participants are treated with daily morning bright light for 6 weeks. Reduction in depression scores and tolerability is recorded.


Eligibility Criteria:
Inclusion Criteria:

Seasonal affective disorder. Visual impairment (Snellen visual acuity \< 6/18) or visual field reduction (MD\<10).

Exclusion Criteria:

Alcohol or drug abuse. Current or planned pregnancy. Other neuropsychiatric disorder. Antidepressant medication. Regular use of melatonin.
Orexin Gene in Anorexia Nervosa

The objectives of this study will be to determine the methylation of the promoter of the Orexin A (OX-A) and B (OX-B) genes in young women (\> 18 years) with Anorexia Nervosa (AN), compared with a control group; and to evaluate the relationship of promoter methylation of the genes for OX-A and OX-B with the severity of the eating disorder, psychiatric comorbidities (in particular, depression), and sleep quality.


Eligibility Criteria:
Patients with Anorexia Nervosa:

Inclusion Criteria:

* Female sex
* Age 18 years and older
* Anorexia Nervosa
* Hospitalized at the Division of Eating and Nutrition Disorders, Istituto Auxologico Italiano, IRCCS, Piancavallo, Italy

Exclusion Criteria:

* Absence of signed informed consent

Control group:

Inclusion Criteria:

* Female sex
* Age 18 years and older
* Body Mass Index between 18.5 and 24.9 kg/m2

Exclusion Criteria:

* Absence of signed informed consent
* Presence of any physical and mental pathology
Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With Schizophrenia

Study to evaluate the safety and efficacy of luvadaxistat compared with placebo on improving cognitive performance in participants with schizophrenia.

A Phase 2, randomized, double-blind, parallel, placebo-controlled study with a 6- or 12-month open-label extension. The study is designed to evaluate the efficacy, safety and tolerability, and pharmacokinetics (PK) of treatment with luvadaxistat when administered orally once daily as an adjunctive treatment on improving symptoms of cognitive impairment associated with schizophrenia (CIAS).

Eligibility Criteria:
Key Inclusion Criteria:

Participants must meet all of the following inclusion criteria:

1. Completed written informed consent.
2. Participant must be 18 to 50 years of age (inclusive) and able to comply with all protocol procedures.
3. Diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
4. The initial diagnosis of schizophrenia must be ≥1 year before screening.
5. The participant is currently receiving a stable regimen of psychotropic medications.
6. Participant has stable symptomatology ≥3 months before the screening visit.
7. The participant must have an adult informant.
8. A body weight of at least 45 kilograms (kg) and a body mass index (BMI) of 18.0 to 45.0 kg/meter squared (m\^2), inclusive.

Key Exclusion Criteria

Participants will be excluded from the study if they meet any of the following criteria:

1. Pregnant or breastfeeding or plans to become pregnant during the study.
2. Exhibit more than a minimal level of extrapyramidal signs/symptoms.
3. Schizophrenia diagnosis occurred before 12 years of age.
4. Lifetime diagnosis of schizoaffective disorder, bipolar disorder, or obsessive-compulsive disorder.
5. Recent occurrence of panic disorder, depressive episode, or other comorbid psychiatric conditions.
6. Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within 6 months before screening.
7. Diagnosis of moderate or severe substance use disorder (with the exception of nicotine dependence) within 12 months prior to screening.
8. Positive drug screen for disallowed substances.
9. Any other medical or psychiatric condition or cognitive impairment that may interfere with study conduct or clinical assessments.
Microarray Expression Profiling to Identify Stereotypic mRNA Profiles in Human Parturition

The understanding of the biological mechanisms underlying preterm birth is very limited, making prevention of preterm birth difficult. The incidence of preterm birth worldwide varies between 6%-11% in singleton pregnancies, and 64-93% of preterm deliveries occur after the spontaneous onset of labor (preterm labor). The risk factors associated with preterm birth include demographic variables such as ethnic group, past obstetric history, and complications of the current pregnancy such as infection and fetal congenital anomalies. The current study aims to investigate the basic mechanisms of preterm labor by systematically cataloging the changes in expression levels of all expressed genes whose sequences are available. The goals will be accomplished by using microarray technology followed by subsequent confirmative or complementary analyses.

The understanding of the biological mechanisms underlying preterm birth is very limited, making prevention of preterm birth difficult. The incidence of preterm birth worldwide varies between 6%-11% in singleton pregnancies, and 64-93% of preterm deliveries occur after the spontaneous onset of labor (preterm labor). The risk factors associated with preterm birth include demographic variables such as ethnic group, past obstetric history, and complications of the current pregnancy such as infection and fetal congenital anomalies. The current study aims to investigate the basic mechanisms of preterm labor by systematically cataloging the changes in expression levels of all expressed genes whose sequences are available. The goals will be accomplished by using microarray technology followed by subsequent confirmative or complementary analyses.

Eligibility Criteria:
* INCLUSION CRITERIA:

Consecutive patients admitted with the following diagnoses from four different ethnic groups (Hispanic, African American, Asian, and Caucasian):

1. Preterm labor with intact membranes and with

   1. acute inflammation;
   2. chronic villitis;
   3. vascular pathology;
   4. no identifiable lesions.
2. Preterm delivery without labor because of the following reasons:

   1. pre-eclampsia;
   2. abruptio placentae;
   3. fetal anomalies;
   4. Other complications (e.g. automobile accidents) that necessitate immediate delivery.
3. PROM leading to preterm delivery and with

   1. acute inflammation;
   2. chronic villitis;
   3. vascular pathology;
   4. no identifiable lesions.
4. Term delivery without labor and no identifiable lesions.
5. Term delivery in spontaneous labor and no identifiable lesions.
6. Term delivery with chorioamnionitis.
7. Term delivery with failed labor leading to ceasarean section.

EXCLUSION CRITERIA:

1. Refusal of written informed consent
2. Fetal or maternal conditions mandating immediate delivery (i.e. fetal distress, significant hemorrhage, etc.)
A Study of MY008211A in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

The main purpose of this study is to evaluate the efficacy of MY008211A in adult patients with PNH , showing signs of active hemolysis, in China.

The purpose of this study is to determine whether MY008211A is efficacious and safe for the treatment of PNH patients who are naive to complement inhibitor therapy, including anti-C5 antibody.

Eligibility Criteria:
Inclusion Criteria:

* Male and female participants ≥ 18 years of age, BMI≥18 kg/m2，with a diagnosis of PNH confirmed by laboratory tests, according to the PNH diagnostic criteria in the Chinese Guidelines for the Diagnosis and Treatment of Rare Diseases (2019 edition) , and flow cytometry with clone size ≥ 10%.
* Mean hemoglobin level \<100 g/L.
* LDH \> 1.5 x Upper Limit of Normal (ULN)
* Vaccination against Neisseria meningitidis infection is required prior to the start of study treatment. If not received previously, vaccination against Streptococcus pneumoniae and Haemophilus influenzae infections should be given.

Exclusion Criteria:

* Patients with reticulocytes \<100x10\^9/L; platelets \<30x10\^9/L; neutrophils \<0.5x10\^9/L.
* Were using a complement inhibitor before the first administration of MY008211A tablets or had discontinued a previous complement inhibitor for less than five half-lives or 120 days, whichever was the longest.
* History of recurrent invasive infections caused by encapsulated organisms, e.g. meningococcus or pneumococcus.
* Known or suspected hereditary complement deficiency
* Previous bone marrow or hematopoietic stem cell transplantation.
* Previous splenectomy.
* A history of malignancy within 5 years before screening, except cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.