cyrilzakka/clinical-trials huggingface dataset:
The Role of Mind Body Therapy in Geriatric Rehabilitation

Background: The main goal of geriatric rehabilitation reconditioning following an acute illness is rapid restoration of normal activity. Key elements are pain control, restoration of bowel functions, sleep, appetite and general well-being, along side the physical activity.

Objective: To assess the effect of mind-body intervention as an adjunct to medical and physical rehabilitation in geriatric patients.

Design: Prospective study Setting: University affiliated large city general hospital


Eligibility Criteria:
Inclusion Criteria:

* suitable candidates had to be aged 18 years or older
* treated in the Geriatric Rehabilitation Department in the Tel Aviv Sourasky Medical Center (TASMC) and
* were willing and able to complete the study protocol.

Exclusion Criteria:

* severe unstable chronic illness (e.g., congestive heart failure, chronic renal failure, cancer).
Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live, Cold-Adapted (CAIV-T) in Healthy Children

- The purpose of this study is to determine the efficacy of CAIV-T in a diverse Asian population aged from 6 months to less than 36 months, in tropical and temperate climates, against culture-confirmed influenza illness. In addition, the trial provides the opportunity to investigate the efficacy of CAIV-T over multiple influenza seasons, and to investigate the effect of CAIV-T on acute otitis media.


Eligibility Criteria:
Inclusion Criteria:

* who are greater than or equal to 6 months and less than 36 months of age at the time of enrollment, and in good health as determined by medical history, physical examination, and clinical judgment;
* whose parent or legal guardian has provided written informed consent after the nature of the study has been explained;
* who, along with their parent or legal guardian, will be available for the duration of the study (24 months);
* whose parent/legal guardian can be reached by study staff for the post-immunization contacts \[via telephone, clinic or home visits\].

Exclusion Criteria:

* whose parents or caregiver are perceived to be unreliable or difficult to contact for evaluation or study visits during the study period;
* with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;
* with Down's syndrome or other known cytogenetic disorders;
* with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids;
* who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study;
* for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study;
* with an immunosuppressed or compromised individual living in the same household;
* who, at any time prior to entry into this study, received a dose of any influenza vaccine (commercial or investigational);
* who were administered any live virus vaccine within one month prior to study vaccination or expected receipt of another live virus within one month of vaccination in this study;
* with a documented history of hypersensitivity to egg or egg protein, or any other component of the study vaccines or placebo;
* with a respiratory illness with wheezing within two weeks prior to enrollment;
* who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrollment or for which use is anticipated during the study;
* with any medical conditions that in the opinion of the Investigator might interfere with interpretation of the study results; Note: A pregnant household member or day care provider is not considered a contraindication to enrollment.
A Study of Second Look Laparoscopy (SLL) in People With Ovarian Cancer Who Have Completed Their First Course of Chemotherapy

The researchers are doing this study to look at the health outcomes of people with advanced ovarian cancer who have a second look laparoscopy (SLL) after they complete their first course of chemotherapy. The researchers will compare the health outcomes of people who have minimal residual disease (MRD-small amounts of cancer cells in the body after a person receives treatment) at the time of SLL with the health outcomes of people who do not have MRD at the time of SLL. The researchers are also doing this study to determine if SLL is safe and practical (feasible) in people with advanced ovarian cancer who have completed the first course of therapy for their disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients assigned female at birth≥ 18 years of age
* Suspected or known stage III-IV epithelial ovarian cancer for which the patient has undergone, or is planned to undergo, attempted primary or interval debulking surgery
* Homologous Recombination Deficiency testing should be planned to be completed prior to completion of initial platinum/taxane chemotherapy. HRD testing can be determined using :

  * Confirmation of deleterious Somatic or Germline BRCA mutation
  * CLIA certified test for HRD
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

Exclusion Criteria:

* Patients with the inability to swallow oral medications or impaired gastrointestinal absorption due to gastrectomy or drainage gastrostomy tube
* Patients receiving standard of care or investigational protocol directed treatment are eligible for this study, with the exception of protocol directed treatment which would prohibit the SLL surgery from being performed
Antiresorptive Effect of Treatment With Risedronate and Vitamin D in Postmenopausal Patients

Osteoporosis is defined as a systemic disease of bone mineralization, characterized by a decrease in bone mineral density that causes bone fragility and increases the risk of fractures during menopause. Recently, a high prevalence of hypovitaminosis D has been found worldwide, which could trigger a state of secondary hyperparathyroidism that can worsen the state of postmenopausal patients with osteoporosis. An open-label, clinical trial was conducted in Mexican women with postmenopausal osteopenia-osteoporosis to determine the efficacy of the combined treatment with risedronate and high-dose vitamin D in improving bone mineral density, hyperparathyroidism, and hypovitaminosis D.

Participants were selected from the climacteric clinic of the regional hospital "1ro de Octubre-Instituto de Seguridad y Servicios Sociales para Los Trabajadores del Estado (ISSSTE)", Mexico. All participants voluntarily accepted to be part of the study and provided written informed consent.This study was approved by the institutional ethical committee of the hospital with registration number COFEPRIS 17 CI 09005135 with the internal registration number 118.2021. Every participant was clinically examined. Their metabolic state was assessed by considering height, weight, body mass index (BMI) and the percentage of Hb1Ac.

33 patients were included among 40 to 78 years with the diagnosis of postmenopausal osteoporosis with associated hyperparathyroidism, hypovitaminosis D or both conditions. All the patients were treated for 6 months with 35 mg of risedronate and 2800 IU of vitamin D once a week, with additional daily supplementation of 4000 IU of vitamin D.

Statical analysis was performed using PAST 3.0 and GraphPad Prism 8.4.3. software. Some statical parameters, such as arithmetic median (µ), and standard deviation (S.D.) were calculated using Excel-Word. Graphics were constructed with GraphPad Prism 8.4.3 and tables were done in Excel-Word. The assigned α value for this study was \<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Participants with a diagnosis of postmenopausal osteoporosis or osteopenia.
* Participants with a diagnosis of hyperparathyroidism or hypovitaminosis D.
* Participants who accepted to participate and that provided informed consent.

Exclusion Criteria:

* Participants with oncological pathologies.
* Participants with recent fractures.
* Participants with gastric intolerance or hypersensitivity to the drugs.
* Participants were under treatment with another antiresorptive or bone-forming drug, or if they were receiving treatment with thiazide diuretics, lithium, teriparatide or glucocorticoids.
* Participants with Addison's disease, pheochromocytoma or depressive disorders.
Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of Toripalimab for Patients With Recurrent Malignant Lymphoma

The primary objective is to assess the safety and tolerability of JS-001 in subjects with recurrent malignant lymphoma, and to evaluate its preliminary efficacy.

The secondary objectives are to: 1) characterize the single-dose and multi-dose pharmacokinetic (PK) profile of JS-001, 2) characterize the immunogenicity of JS-001; 3) assess the dose-efficacy relationship of JS-001 single agent, and 4) preliminarily evaluate biomarkers associated with the efficacy of JS-001.


Eligibility Criteria:
Inclusion Criteria:

* Willing to sign Informed Consent;
* Re-entry into the study is allowed with a second informed consent;
* Willing to provide blood sample for biomarker analysis(mandatory). The tissue sample is optional;
* A diagnosis of an advanced malignant tumor confirmed by histology or cytology (including typical Hodgkin's lymphoma and B cell source non-hodgkin's lymphoma);
* No standard of care for the patient;
* At least 1 measurable lesion;
* Aged 18-65 years;
* Anticipated life expectancy of at least 6 months;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
* At least 4 weeks elapsed since receiving systemic chemotherapy;
* At least 4 weeks elapsed since receiving definite radiotherapy;
* At least 2 weeks since the last dose of systemic steroid therapy (\>10 mg/day prednisone or equivalent);
* At least 4 weeks since receiving anti-cancer biotherapy;
* Recovered from previous treatment related adverse reaction; willing to use an acceptable contraceptive method;
* A negative pregnancy test for female subjects of childbearing potential;

Exclusion Criteria:

* Active central nervous system (CNS) metastases and/or carcinomatous meningitis;
* Known history of another primary solid tumor, unless the participant has undergone potentially curative therapy with no evidence of that disease for 2 years, or underwent successful definitive resection of basal or squamous cell carcinoma of the skin, or in situ cervical cancer;
* Active, known or suspected autoimmune disease.Autoimmune diseases caused by lymphoma are not included in this list;
* Patients who have had car-T cell therapy
* Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) blocking antibodies;
* Significant medical disease;
* Active infection;
* Active tuberculosis or history of tuberculosis with one year;
* Infection of Human immunodeficiency virus (HIV);
* A complication requiring immune-suppression;
* Received a live vaccine within 4 weeks prior to first dose of study drug pleural or abdominal effusion with symptoms;
* Drug or alcohol abuse (for subjects in the pharmacokinetic cohorts) ; evidence of interstitial lung disease;
* Active hepatitis B or C, or with significant risk of hepatitis reactivation;
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to monoclonal antibodies or drugs chemically related to the study drug. History of serious hypersensitivity reaction or serious hepatotoxicity related to any drug.
Evaluation of Food Insecurity in Adults and Children With Cystic Fibrosis

A survey of adults and parents of children with cystic fibrosis on food insecurity

A survey of adults and parents of children with cystic fibrosis to determine any correlation between food insecurity and BMI or food insecurity and FEV1, and to determine what level of food insecurity is present.

Eligibility Criteria:
Inclusion Criteria: have CF and are willing to complete a questionnaire during a routine clinic visit

-

Exclusion Criteria:

* NA
Descriptive Study of Receptive Fields in Lower Limb Amputees

It has been observed that patients subjected to amputations develop so called receptive fields, which time of occurrence and localization over time are yet not examined systematically.

This clinical trial aims to investigate the reliability in detecting these receptive fields as well as their incidence and changes over time.

Further it aims to evaluate the acute effect of a stimulating system ("Phantom Stimulator" (Cort X Sensorics, Spaichingen, Germany)) on selected gait parameters measured tough a gait analysis system ("OprtoGait" (Microgate, Bolzano, Italy)) as well as on phantom sensations measured through a questionnaire.

It has been observed that patients subjected to amputations develop so called receptive fields, which time of occurrence and localization over time are yet not examined systematically.

A receptive field is defined as skin area anywhere on the same side of the body as the amputation, which when stimulated by others, causes phantom sensations in the amputated extremity.

This clinical trial aims to investigate the reliability in detecting these receptive fields as well as their incidence and changes over time.

Further it aims to evaluate the acute effect of the stimulating system ("Phantom Stimulator" (Cort X Sensorics, Spaichingen, Germany)) on selected gait parameters measured tough a gait analysis system ("OprtoGait" (Microgate, Bolzano, Italy)) as well as on phantom sensations measured through a questionnaire.

Eligibility Criteria:
1. Inclusion criteria for descriptive study:

   a. Lower limb amputation (independently of side or height of amputation)
2. Inclusion criteria for Phantom stimulator:

   1. Receptive fields present at testing day 31 (last regular assessment of the receptive fields)
   2. Lower limb amputation below the knee (if both sides the system is applied to the dominant side).
3. Exclusion criteria:

   1. Implanted devices (defibrillator or pacemaker)
   2. Pregnancy
Efficiency of Antagonist Drugs of the Cellular Transcriptomic Signature of Influenza A Virus Infection.

The aim of this study is to evaluate the possibility to repropose marketed drugs as antiviral ones, based on their ability to reverse the transcriptomic signature of the infected cells. This strategy has to be considered is the context of emerging viral diseases and of increase of resistance to antivirals. Concerning infection by Influenza viruses, the main drugs were identified and evaluated on in vitro and in vivo models: diltiazem. Therefore, it will be assess the efficacy of these the drug, compared to placebo, to treat severe flu.


Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized in intensive care units,
* patients with mechanical ventilation invasive or non-invasive or Optiflow® ventilation system.
* for a suspicion of severe flu,
* with a symptoms for less than 96 hours,
* and a respiratory failure defined by the necessity to resort to mechanical ventilation, invasive or Optiflow® Ventilation System The inclusion is conditioned to the detection of Influenza A viruses by PCR on nasopharyngeal swab.

Exclusion Criteria:

* No consent.
* Hypersensibility to Oseltamivir
* Negative PCR on nasopharyngeal swab
* Symptoms for more than 96 hours.
* Moribund patients at inclusion.
* Pregnant/nursing woman.
* Patients already taking diltiazem in the 48 hours before.
* Patients having taken more than 3 intakes of oseltamivir before randomization.
* Hemodynamic instability needing a dose of noradrenaline exceeding 2mg/h

Contraindication to diltiazem:

* sinusal dysfunction without device.
* auriculo-ventricular heart block without device.
* Cardiogenic pulmonary oedema.
* Left cardiac failure
* bradycardia\<40/min
* Concomitant use of beta-blockers, antiarrythmic drugs, especially amiodarone.
* Concomitant use of ivabradine, pimozide, nifedipine, ergot alkaloids.
Safety and Effectiveness of Combretastatin A-4 Phosphate Combined With Chemotherapy in Advanced Solid Tumors

This is a study evaluating the safety and effectiveness of Combretastatin A4 Phosphate (CA4P) combined with the chemotherapy drugs, carboplatin and paclitaxel. The full treatment and observation time should be about 5 months. During this time the patient should receive 18 CA4P infusions and 6 carboplatin followed by paclitaxel treatments. Patients will be randomized into one of two CA4P dose-level groups in order to recommend a preferred dose-level for future studies. At least 2 dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) scans will be conducted to monitor the blood flow through the tumor before and after treatment with CA4P.

This is a phase II study evaluating the safety and efficacy of Combretastatin A4 Phosphate (CA4P) combined with carboplatin and paclitaxel. Treatment is for a maximum of 6 consecutive 21-day cycles. Patients are randomized onto one of two CA4P dosing arms (45 or 63 mg/m2). CA4P is administered on days 1, 8 and 15 of each cycle. Carboplatin and paclitaxel (AUC 6 and 200 mg/m2, respectively) are administered on day 2 of each cycle. At least 2 DCE-MRI scans will be performed to evaluate the change in tumor blood flow following treatment with CA4P.

Eligibility Criteria:
Inclusion Criteria:

* Advanced malignancy where treatment with carboplatin and paclitaxel is warranted.
* Minimum 28-day interval from any surgical, chemotherapy or immunotherapy treatment and a 14-day interval from radiotherapy treatment.
* Radiologically measurable disease to meet MRI perfusion criteria.
* ECOG performance status less than or equal to 1.
* Life expectancy greater than 12 weeks.
* Normal ejection fraction.

Exclusion Criteria:

* Uncontrolled brain metastasis.
* Significant cardiac abnormalities.
* Prior radiotherapy at the tumor site.
* Symptomatic peripheral vascular or cerebrovascular disease.
* Uncontrolled hypertension.
A COHORT STUDY TO EVALUATE IMMUNOGENICITY FOR CHINESE CHILDREN AT THE TIME OF CLINICAL PNEUMONIA DIAGNOSIS

This is a PAC study after PCV13 launch in China. Based on recommendation from China Agency, Pfizer was required to conduct a descriptive immunogenicity study to measure the antibody levels at the time of disease onset.


Eligibility Criteria:
Inclusion Criteria:

1. Evidence of a personally signed and dated informed consent document indicating that the parent(s)/legal guardian has been informed of all pertinent aspects of the study.
2. Subjects whose caregiver is willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
3. A diagnosis of clinical pneumonia per SCH standard of care.
4. 5 months to ≤60 months of age at the time of consent.
5. Vaccination history (ie, vaccine book or picture of vaccine book) is available for confirmation.

Exclusion Criteria:

1. Infant or child who is a family member of:

   * Investigator site staff members directly involved in the conduct of the study;
   * Site staff members otherwise supervised by the investigator;
   * Pfizer employees directly involved in the conduct of the study.
2. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
3. Blood draw is counter indicated.
4. Previous participation in this study within 30 days.
5. Previous vaccination with licensed or investigational pneumococcal vaccine. This excludes previous vaccination with 13vPnC as per the approved recommendations in China.
6. Received blood, blood fractions, plasma, or immunoglobulins within 3 months of the study blood draw.
7. Hospital acquired pneumonia (ie, onset \>48 hours after hospitalization).
Pilot Cohort Study of Rb-82 Myocardial PET Imaging to Evaluate Coronary Microvascular Dysfunction in Men With Prostate Cancer Receiving Androgen-Deprivation Therapy

To determine the feasibility of using myocardial PET imaging as a means to assess cardiovascular risk in men with prostate cancer planned for androgen- deprivation therapy with external beam radiation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Either clinically localized prostate cancer or biochemically-recurrent prostate cancer patients who are planned for at least 6 months ADT with a GnRH agonist and curative-intent radiation therapy per their oncologic providers.
* Over 50 years of age. Calculated 10-year Framingham General Cardiovascular Risk Score of ≥10% at the time of planned initiation of ADT.
* Patients must be able to read and understand English.
* Participants must sign the informed consent form.

Exclusion Criteria:

* Prior treatment with GnRH agonist therapy.
* History of active asthma or other reactive airway disease.
* Ischemic cardiac event (myocardial infarction, unstable angina) within the preceding 6 months.
Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever

Abstract Background Tick-Borne Relapsing Fever (TBRF) is an acute febrile illness. In Israel, TBRF is caused by Borrelia persica and is transmitted by Ornithodoros tholozani ticks. We examined the safety and efficacy of a post exposure treatment policy to prevent TBRF.

Methods In a double blind, placebo controlled trial 93 healthy volunteers with suspected tick exposure (51 with bite signs and 42 contacts) were randomly assigned to receive either Doxycycline (200 mg for the first day and 100mg/d for 4 days) or placebo, approximately 2 days after contact. Blood smears were examined for Borrelia at inclusion and during fever rise. Serology for Lyme disease cross- reactivity and PCR for Borrelia GlpQ gene were also performed. Cases of TBRF were defined as subjects having fever and a positive blood smear.


Eligibility Criteria:
Inclusion Criteria:

* suspected exposure to tick-borne relapsing fever
* after returning from field exercise in a tick-borne relapsing fever infected area
* having a tick bite or staying in field in close proximity to a subject with tick bite sign

Exclusion Criteria:

* known sensitivity to tetracycline or doxycycline
* febrile illness on recruitment
Step Count Monitoring as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Undergoing Radiation Therapy

This trial studies the feasibility of monitoring step count as a measure of physical activity in patients with newly diagnosed glioma undergoing radiation therapy. Physical activity measured by step count may help to improve the quality of life and symptoms for patients with newly diagnosed glioma.

PRIMARY OBJECTIVE:

I. Evaluate the feasibility of monitoring step count as a measure of physical activity in patients with newly diagnosed glioma undergoing radiation therapy (RT) at MD Anderson Cancer Center (MDACC).

SECONDARY OBJECTIVE:

I. Estimate the effects of physical activity as measured by step count on cognition, fatigue, anxiety and depression scores and assess differences between groups.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients wear a pedometer for step count monitoring over 6 weeks.

GROUP II: Patients wear a FitBit for step count monitoring over 6 weeks.

After completion of study, patients are followed up at 3 and 6 months after completing radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a glioma and going to receive at least 4 weeks of RT at MDACC at the Texas Medical Center campus with at least 20 fractions
* Karnofsky performance status (KPS) of 70 or above
* Wearable activity tracker (WAT) - naive
* Able to read and speak English
* Able to provide informed consent
* Access to a smartphone
* Access to Wi-Fi

Exclusion Criteria:

* Cognitive and/or major sensory deficits that would impede the completion of assessment instruments as deemed by the clinical team