cyrilzakka/clinical-trials huggingface dataset:
rTMS Posterior Parietal Cortex Modulation and Upper Limb Movement After Stroke

This study evaluates the effect of a unique session of inhibitory rTMS (cTBS) over the contralesional posterio parietal cortex (PPC) on the spatio-temporal parameters of a pointing movement performed by stroke patients with their paretic upper limb. It will also assess the effects on the resting motor threshold of both hemispheres and on parietopremotor connectivity.

To achieve theses aims, the real cTBS stimulation will be randomly counterbalanced with a SHAM stimulation (in a second session) in a crossover design. Assessments will be performed before and after each stimulation session.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80y
* Right-handed
* Right hemispheric stroke confirmed by a 3D imaging technique
* at the chronic phase (\>6months)
* subject being able to perform a pointing movement of at least 20cm in the anterior space without compensatory movements of the trunk
* informed consent
* Social security affiliation

Exclusion Criteria:

* Severe comprehension troubles (language, cognitive or psychiatric disorders)
* History of neurological disorders in addition to the stroke
* Locomotor troubles affecting the paretic arm
* Contraindication to rTMS : epilepsy, intracranial metallic foreign body, cochlear implant, unstable fracture of the skull bones, deafness
* pregnancy or breastfeeding
* adult subject to guardianship
Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response

This prospective, single-arm feasibility study will include patients with prostate cancer that have controlled local disease diagnosed with oligorecurrent para-aortic nodal disease and/or common iliac nodal disease detected by PSMA PET or conventional CT/MRI imaging, and these patients will undergo CT-guided online adaptive SBRT to the tumor and elective SBRT to adjacent at-risk nodal regions.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed prostate adenocarcinoma.
2. Oligorecurrent para-aortic +/- common iliac nodal disease planned for SBRT.
3. ≤10 involved para-aortic (defined as between L1/L2 interface and L4/L5 interface) +/- common iliac LN on PSMA PET imaging.
4. ECOG performance status 0-2.

Exclusion Criteria:

1. Prior radiotherapy to the nodal echelon (PA +/- common iliac).
2. Active secondary malignancy, except for adequately treated non-melanoma skin cancer.
3. Presence of significant comorbidities or medical conditions that may compromise the ability to undergo radiotherapy or participate in the study.
4. Contraindication to radiation.
Assessment of Frailty as a Risk Factor for Cardiac and Vascular Surgery

The purpose of this study is to assess the impact of frailty as a multidimensional risk factor on the outcomes of adult cardiac and vascular surgery. For the purpose of defining patient frailty a multimodal questionnaire has been developed including measurement of psychological, socioeconomical, neurological and behavioral aspects. This study also features an investigation of the possible relationship between sudden regional weather changes, individual meteorological susceptibility of the patients and the outcomes of adult cardiac and vascular surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients, 18 years or older, admitted to the hospital for elective cardiac or vascular surgery.

Exclusion Criteria:

* Not willing to participate.
* Pregnant women.
* During active psychiatric hospital care.
* Patients with defined legal incapability or limited capability.
* Congenital or acquired speech impediment and locomotion disability of any kind.
* Non-evaluable patient due to communication problems and insufficient clinical information for the judgement of frailty (CFS).
* Patients admitted solely for elective surgery of the varices of the lower extremities.
* Patients with a transplanted heart.
Nivolumab With Chemotherapy in Refractory MDS

There is evidence of involvement of checkpoint pathways, including PD-1, in the pathogenesis and resistance of myelodysplastic syndrome (MDS). However monotherapy with checkpoint inhibitors was ineffective in a number of studies, indicating the presence of several mechanisms of resistance. This pilot study evaluates the safety and preliminary efficacy of nivolumab combination with currently existing treatments in MDS patients who failed at least one line of therapy. The study evaluates if there is a combination which induces objective responses.


Eligibility Criteria:
Inclusion Criteria:

* Patients with myelodysplastic syndrome (MDS) (up to 20% blasts) of any risk. Patients with lower risk MDS (low and int-1 by IPSS) should have failed prior non-hypomethylating agent therapy (ie growth factors or lenalidomide). Patients with higher risk MDS (int-2 or high by IPSS) should have failed prior at least one therapy with a hypomethylating agent or Ara-C.
* Age 18 years or older.
* No severe organ dysfunction: creatinine \<=2.5 x ULN; serum bilirubin \<=2.5 x ULN; AST and ALT \<=5 x ULN.
* Karnofsky index \>=70%
* Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (beta-hCG) pregnancy test result within 24 hours prior to the first dose of treatment and must agree to use an effective contraception to avoid pregnancy for 24 weeks
* Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 24 weeks after the last dose of nivolumab.

Exclusion Criteria:

* Another malignancy requiring treatment at the time of inclusion
* History of interstitial lung disease or pneumonitis
* Patients with any other known concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure NYHA Class III or IV, myocardial infarction within 6 months, and poorly controlled hypertension; chronic renal failure; or active uncontrolled infection) which, in the opinion of the investigator could compromise participation in the study
* Active, known or suspected autoimmune disease requiring treatment at the time of inclusion
* Pregnancy or breastfeeding
* Patients unwilling or unable to comply with the protocol
* Somatic or psychiatric disorder making the patient unable to sign informed consent
* Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA4 therapy
Shear Wave Elastography for Diagnosis of Heart Failure With Preserved Ejection Fraction

The diagnosis of heart failure with preserved ejection fraction (HFpEF) is often complex. Echocardiography has the advantages of being a non-invasive, simple operation, low price, and high repeatability, and is of great value in the diagnosis of HFpEF. However, the current echocardiographic assessment of left ventricular diastolic dysfunction and elevated filling pressure is based on multi-parameter indirect judgment, and new parameters are urgently needed to achieve accurate judgment of left ventricular diastolic function and an accurate diagnosis of HFpEF. Myocardial stiffness refers to the ability of the myocardium to undergo stress and strain. It is an important part of the pathophysiology of cardiac diastolic dysfunction and an important parameter for clinical evaluation of the diastolic function of HFpEF. Shear-wave elastography is a novel ultrasound-based elastography technology. Based on the shear wave generated by the remote induction of the radiation force of the focused ultrasound beam, the hardness of myocardial tissue can be measured quantitatively, locally, and noninvasively, and the change in myocardial stiffness in patients with HFpEF can be directly reflected. Currently, no relevant studies have applied shear-wave elastography to the diagnosis of HFpEF. This study aims to identify changes in myocardial stiffness measured by shear-wave elastography in patients with HFpEF based on a multicenter study and apply myocardial stiffness parameters to the diagnosis of HFpEF.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old
2. Clear epidemiological and population characteristics of HFpEF
3. Symptoms and/or signs of heart failure
4. Echocardiographic examination of LVEF≥50%
5. Objective evidence of cardiac structural and/or functional abnormalities consistent with left ventricular diastolic dysfunction and/or elevated left ventricular filling pressure, including elevated levels of natriuretic peptides
6. HFpEF score ≥6 or HFA-PEFF score ≥5

Exclusion Criteria:

Any one item per patient was excluded from the study:

1. Arrhythmia.
2. ischemic heart disease.
3. Valvular heart disease or congenital heart disease with severe hemodynamic changes.
4. History of pacemaker implantation or other cardiac surgery.
5. Poor ultrasonic image quality cannot meet the parameter measurement and analysis.
Pneumococcal Conjugate Vaccine With Pneumococcal Polysaccharide Vaccine and Tetanus/Diphtheria Vaccine

The purpose of this study is to learn whether or not giving a tetanus/diphtheria vaccination ("tetanus shot") before giving pneumococcal vaccine makes the pneumococcal vaccine more effective without causing too many side effects.

The only vaccine licensed in the United States for protecting adults against pneumococcal disease (PPV23) protects against invasive disease in observational studies but has generally been poorly effective against pneumonia or all-cause mortality in randomized clinical trials. Another vaccine containing seven polysaccharide antigens conjugated to diphtheria toxoid (PCV7) is licensed for children and under investigation in adults.

In this pilot study, we are comparing the safety and immunogenicity of three immunization schedules in adults:

* Td vaccine, 2-week interval, PCV7, 4-month interval, PPV23
* PCV7, 4-month interval, PPV23
* PPV23

We aim to:

* compare the safety profiles of pneumococcal vaccines given on each of the three schedules
* compare serotype-specific ELISA antibody response to pneumococcal antigens given on each of the three schedules
* compare functional serotype-specific antibody responses to pneumococcal antigens given on each of the three schedules
* study the influence of diphtheria antibody levels at the time of pneumococcal conjugate vaccine administration on the magnitude of the immune response to pneumococcal antigens

Eligibility Criteria:
Exclusion Criteria:

* Participation in any other investigational clinical trials except purely observational studies within 4 weeks prior to study start
* Any vaccination within 2 weeks prior to first study vaccine
* Evidence of systemic or local infection within one week prior to first study vaccine
* HIV infection
* Renal failure
* Receipt of a pneumococcal or Td vaccine within 5 years
* Current receipt of therapy for neoplastic disease
* Current receipt of immunosuppressive therapy
* Terminal illness withlife expectancy less than 3 months
Effect of Conventional Therapy and Low Level Laser Therapy on Pain and Function in Patients With Temporomandibular Joint Dysfunction

This study was to determine the effect of conventional therapy and low level laser therapy on pain and function in patients with temporomandibular joint dysfunction. sixty patients with myofascial pain syndrome of TMJ are randomly classified into two groups with thirty patients in each group; Group I received traditional exercise. Group II received low level laser therapy in addition to traditional exercise. All outcome measures including Pain and function, were evaluated before and after the treatment program.

METHODOLOGY

Subjects: This prospective study was conducted on thirty patients of both genders with myofascial pain syndrome of TMJ in the department of physical therapy at October 6 university Hospital from December 2016 to October 2017. The Patients were selected to be enrolled into this study according to the following criteria:

Eligibility Criteria:
Inclusion Criteria:

* All patients are diagnosed as myofascial pain syndrome of TMJ.

Exclusion Criteria:

* Presence of systematic musculo-articular pathologies.
* Pregnant women.
* History of facial trauma.
* Facial palsy.
* Fractures of the facial bones.
Effects of Growth Hormone Releasing Hormone in HIV

HIV-infection and its treatment are often associated with an increase in belly fat, as well as abnormal cholesterol and problems metabolizing sugar. People with HIV infection and increased belly fat often have decreased growth hormone (GH) levels. Low GH levels may contribute independently to increased belly fat and to increased cardiovascular risk through effects on sugar metabolism, inflammation, and other mechanisms. Tesamorelin, a growth hormone releasing hormone (GHRH) analogue, has been shown to to reduce belly fat in patients with HIV-associated abdominal fat accumulation. However, the effects of tesamorelin on fat accumulation in the liver and muscle, sugar metabolism, and cardiovascular health are not yet known. The current study is designed to determine the effects of tesamorelin treatment on fat accumulation in the muscle and liver, insulin sensitivity and sugar metabolism, and markers of cardiovascular health including blood vessel thickness (carotid intima media thickness \[cIMT\]) and markers of inflammation in the body. The investigators hypothesize that tesamorelin will decrease fat accumulation in the liver and muscle and will decrease markers of inflammation, with either neutral or beneficial effects on glucose metabolism.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women age 18-65
2. Previously diagnosed HIV infection
3. Stable antiviral regimen for at least 12 weeks prior to enrollment
4. WC\>95 cm and WHR\>0.94 for male, WC\>94 cm and WHR\>0.88 for female occurring in the context of treatment for HIV disease
5. Subjective evidence of at least one of the following recent changes, occurring during the treatment of HIV disease: increased abdominal girth, relative loss of fat in the extremities, or relative loss of fat in the face
6. For female subjects 40yo or older, negative mammogram within one year of baseline

Exclusion Criteria:

1. Use of anti-diabetic agents, Megace, testosterone or any steroid use within 6 months of the study. Stable use of testosterone (\> 6 mos) at dose equivalent to 200 mg IM q 2 weeks or \< 10g/day to skin will be permitted.
2. Use of GH or GHRH within the past 6 months
3. Change in lipid lowering or antihypertensive regimen within 3 months of screening
4. Fasting blood sugar \> 126 mg/dL, SGOT \> 2.5 times ULN, HgB \< 12.0 g/dL, creatinine \> 1.4 mg/dL, CD4 count \< 200
5. Severe chronic illness or active malignancy or history of pituitary malignancy or history of colon cancer
6. For men, history of prostate cancer or evidence of prostate malignancy by PSA \> 5 ng/mL
7. Prior history of hypopituitarism, head irradiation or any other condition known to affect the GH axis
8. For women, positive urine hCG
9. Oral contraceptives, depo provera or combined progesterone-estrogen injections, transdermal contraceptive patches, estrogen or progestin coated IUD's within 6 months of the study.
10. Routine MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clip.
Elastic-explosive Strength Training Combined With Active Joint Mobilizations in Basketball Players

The specific training of the elastic-explosive force of the muscles involved in vertical jump and active mobilizations is used to improve the quality of the jump. It is also intended to reduce the loss of centimeters, recovery times and fatigue produced during a series of vertical jumps.

The objective of the study is to assess the effectiveness of active mobilizations together with specific training in lower limbs, in ankle mobility, the perception of effort and the height and resistance of vertical jumping in amateur basketball players.

Randomized clinical study. 50 basketball players from 20 to 35 years will be randomized to the study groups: control group (resistance strength exercises, elastic-explosive force) and experimental group (resistance strength exercises, elastic-explosive force together with active mobilizations). The dependent variables will be: repeated jump (15 second Jump test, my Jump 2), maximum vertical jump (CMJ free arms, my Jump 2), subjective perception of effort (Borg scale) and ankle dorsiflexion (goniometer). The sample distribution will be calculated using a Kolmogorov-Smmirnof analysis. The changes after each evaluation will be analyzed with the t-student test and with an ANOVA of repeated measures the intra and intersubject effect will be observed. The effect size will be calculated using Cohen's formula.

It is expected to observe an improvement in the resistance of vertical jumps, with a decrease in the loss of centimeters in the repetitions of jumps.


Eligibility Criteria:
Inclusion Criteria:

* Basketball players in the Community of Madrid
* Male
* With an age range of 18 to 35 years
* Federated

Exclusion Criteria:

* Athletes who present an injury at the time of the study
* Who are receiving some parallel physiotherapy intervention
* Have an injury during the experimental or follow-up phase
* Have not signed the informed consent document
Creating and Assessing a Voice Dataset for Automated Classification of Chronic Obstructive Pulmonary Disease

This work aims to evaluate whether voice recordings collected from patients diagnosed with COPD and healthy control groups can be used to detect the disease using machine learning techniques.

Voice data and sociodemographic data on gender and age will be collected through the "VoiceDiganostic" application from the company Voice Diagnostic, which allows one to participate without location dependency. Participants with a diagnosis will be marked as the COPD group, and others will be marked as the healthy control group. Private information such as known comorbidities, personal security numbers, health parameters and communication information will be separately noticed in a participation table for each group.

The collected data will be transformed into mathematical vocal measures called voice features. A dataset consisting of voice features in conjunction with demographics and health data will be constructed for further usage as an input to ML techniques.

Descriptive statistical analysis will be held on attributes containing information on input data and gained outcomes from ML algorithms. The achieved results will be presented in the form of summary tables and graphs.

Eligibility Criteria:
Inclusion Criteria:

* being 18 years old and older.

Exclusion Criteria:

* being under 18 years old.
Cardiac Septal Hypertrophy in the Fetus of Diabetic Mother and Its Effect on Postnatal Cardiac Function

Good glycemic control is superior to poor glycemic control in reducing risk of interventricular septum thickness among fetuses of diabetic mothers

Good glycemic control is superior to poor glycemic control in reducing risk of interventricular septum thickness among fetuses of diabetic mothers specially during third trimester of pregnancy

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* gestational age 36 weeks

Exclusion Criteria:

* congenital anomalies
* obstetric complications
* medical disorders other than diabetes
Perioperative CSF Leak Management - an Opinion Study

Cerebrospinal fluid (CSF) leak is a rare condition. When it involves the ventral skull base, a surgical closure may be achieved using endoscopic skull base surgery techniques. The major principles remain in achieving a watertight closure that can also support the brain (and avoid brain sagging) in case of extensive skull base defects. Surgical techniques are well described. Many clinical factors may influence the successful rate of the reconstruction. However, there is a lack of clinical study on perioperative management of CSF leaks. The purpose of this study is to gather the opinion of skull base surgeons on the post-operative management of patients to avoid CSF leak recurrence.

•Methods: The investigators will collect data from skull base surgeons using an electronic survey questionnaire (Google Form, Google, Mountain View, California, U.S.A.) submitted by e-mail to the members of the French Association of Rhinology, to the European Rhinologic Society, to the French college of neurosurgeons, to the Italian skull base society members, and to the former students of the European endoscopic skull base diploma. This is an anonymous 60-items survey. Questions were classified in eight sections: general questions, material used at the end of the surgical procedure, post-operative resting position, drugs, CSF depletion, post-operative advices, explorations in case of early recurrence of the rhinorrhoea, and follow-up modalities.

•Discussion: The investigators aim to understand the actual practice of skull base surgeons after closure of ventral skull base CSF leaks. This can serve as a basis for conducting clinical studies in the future.


Eligibility Criteria:
Inclusion criteria

An individual must fulfill all of the following criteria in order to be eligible for study enrollment:

* Active skull base surgery practice (ENT surgeon or neurosurgeon)
* Volunteering

Non inclusion criteria

* Subject unable to read or/and write
* Undergraduate students
* Refusal to participate
Liposomal Doxorubicin Plus Gemcitabine Versus Oxaliplatin Plus Fluorouracil/Leucovorin for Hepatocellular Carcinoma

The purpose of this study is to determine that Liposomal Doxorubicin(LD) plus Gemcitabine(GEM) is superior to Oxaliplatin（OXA） Plus Fluorouracil/Leucovorin(FOLFOX4) in prolonging progression-free survival（PFS） in patients with Advanced Hepatocellular Carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients were age 18 to 75 years;
* The patients had histologically, cytologically,or clinically diagnosed unresectable HCC;and were ineligible for local invasive treatment. Clinically diagnosed patients had to have: (1) evidence of HBV or HCV with hepatic cirrhosis; (2) a-fetoprotein levels 400g/L; and (3) morphologic evidence of hypervascular liver tumor. Patients had to have at least one measurable lesion according to RECIST (version 1.0; ≥2 cm on computed tomography \[CT\]; 1 cm on spiral CT or magnetic resonance imaging). Lesions that had undergone previous interventional or local therapy were not considered measurable lesions.
* ECOG score≤2;
* life expectancy 3 months;
* Barcelona Clinic liver cancer (BCLC) stage B or C disease;
* Child-Pugh stage A or B disease;
* Adequate organ and marrow function, with neutrophil count≥1.5X10e9/L, platelet count≥75×10e9/L, AST or ALT﹤2.5×upper limit of normal (ULN), total bilirubin \<1.5×ULN, international normalized ratio \<1.5;normal baseline left ventricular ejection fraction_lower limit of normal for the institution. Patients with AST and ALT\< 5 ×ULN could be recruited if total bilirubin was in the normal range.
* Patients had to provide signed informed consent to participate.

Exclusion Criteria:

* documented allergy to platinum compounds or other study drugs; any previous OXA or DOX treatment, except adjuvant treatment ﹥12 months before random assignment;
* Previous liver transplantation;
* concomitant use of any other anticancer therapy, including interferon alfa and herbal medicine approved by the local authority to be used as anticancer medicine (except palliative radiotherapy to a nontarget lesion);
* CNS metastasis;
* Other serious illness or medical condition.