cyrilzakka/clinical-trials huggingface dataset:
Prospective Determination of COVID-19 Infection Rate in a Chemotherapy Unit in Mexico.

Cancer patients are considered vulnerable to COVID-19 infection. During the pandemic, cancer patients may need to continue their regular treatment of chemotherapy and / or radiotherapy and therefore must visit a hospital unit. As such, they may be at risk for SARS-CoV-2 infection by means of close contact to other patients and health care workers. Hospitals may implement policies to identify symptomatic subjects and limit their access to the chemotherapy / radiotherapy unit. However, asymptomatic COVID-19 positive patients may escape these filters and potentially be contagious to other patients and their health-related workers that care for other several patients. Therefore, there is a real risk of an outbreak that affects a particularly fragile patient population. Patients and their doctors need to know what is the risk associated to visiting a chemotherapy unit in order to decide if the risk outweighs the benefits of cancer treatment in their particular case. To date, this risk is unknown. The study will test patients and health care workers for COVID-19 infection during the peak of the pandemic in a chemotherapy unit in Mexico in order to determine this risk.

In this is prospective cohort, patients with solid tumors and healthcare workers of the chemotherapy and radiotherapy unit at our center will be followed with a daily digital survey and optionally with biweekly PCR tests for SARS-CoV-2. People with symptoms and / or with a positive PCR test for SARS-CoV-2 will be notified and recommendations according to clinical state will be emitted.

Hypothesis: COVID-19 infection rate among patients with solid tumors treated with chemotherapy and / or radiotherapy will be less than 5% during the pandemic period.

Eligibility Criteria:
Inclusion Criteria:

* Patients with solid tumors receiving active oncological treatment (chemotherapy, or radiotherapy or biologic therapy) at our center.
* Age: no limit
* Gender: men and women.
* Health-related worker treating patients with solid tumors at the chemotherapy and radiotherapy unit at our center.
* People who sign an informed consent.

Exclusion Criteria:

* Patients with an hematologic cancer.
* Patients with cancer under surveillance or without active oncological treatment, or receiving treatment in another center.
Disorders of Systemic Glucose Balance

We wish to identify people with hypoglycemia (low blood sugar) and ultimately determine why the blood sugar levels are so low. To do so, we will contrast the responses of patients suspected to have hypoglycemia with those of healthy subjects during standardized tests. Those tests may include: 1) a controlled hypoglycemia produced by administration of insulin, a blood sugar-lowering hormone, and sugar, 2) a formula meal, and 3) a period of up to 72 hours without food.


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected hypoglycemia
* Healthy subjects (controls)
* Absence of known macrovascular disease or of known CNS disease by medical history, physical examination or ECG (exclusions for induced hypoglycemia)
* Ability to give informed consent
Effect Of Paricalcitol (Zemplar) On Endothelial Function And Inflammation In Type 2 Diabetes And Chronic Kidney Disease

The purpose of this research study is to study the effects of paricalcitol on endothelial function and inflammation, cardiovascular risk factors which are associated with patient populations that have Type 2 diabetes and Stage 3 and 4 Chronic Kidney Disease (CKD).

Hypothesis 1: The state of CKD is associated with oxidative stress and inflammation and impaired post ischemic endothelium dependent flow mediated vasodilation which may contribute to atherogenesis.

Hypothesis 2: The administration of paracalcitol to patients with CKD will suppress oxidative stress and inflammation and improve endothelial function and thus contribute to an anti-atherogenic action.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with Type 2 diabetes and CKD
2. Age 18 - 70 years
3. Stable anti-hypertensive and lipid lowering therapy for at least 2 months. All patients should be on an ACEI or ARB unless contraindicated because of side effects (standard of care). No changes in lipid lowering therapy during the 3 months of this study. Blood pressure doses may be changed but new therapy with ACE inhibitors will not be allowed.

Exclusion Criteria:

1. Severe co morbid conditions - e.g. Cancer, etc.
2. Congestive heart failure.
3. Inability to give informed consent or attend study related visits.
4. Have a history of abnormally high vitamin D or calcium levels in the bloodstream.
5. Unwilling or unable to complete screening or data collection procedures.
6. Have a known allergy to the study drug.
7. Pregnant or breast feeding
8. Plasma Calcium \>9 mg/dl
9. Patients should discontinue any calcium supplementation prior to entry into the study.
10. Other vitamin D analogs (eg Sensipar) and vitamin D preparations are contraindicated
Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant

Proof of concept, open-label single center study for the donation of HCV positive kidneys to HCV negative patients, with preemptive, interventional treatment to prevent HCV transmission upon transplantation.

The study objective is to determine if the administration of grazoprevir and elbasvir (with or without ribavirin) for 12-16 weeks after kidney transplantation prevents the spread of HCV infection from a donor kidney with known HCV genotype 1 or 4 infection to a HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks post treatment

Eligibility Criteria:
Inclusion Criteria:

1. Must meet Massachusetts General Hospital (MGH) transplant center criteria and already be listed for isolated kidney transplant
2. No available living kidney donor
3. Has ≤ 730 days (two years) of accrued transplant waiting time if blood type A and ≤ 1095 days of accrued transplant waiting time if blood type B or O.
4. On chronic hemodialysis or peritoneal dialysis or has a glomerular filtration rate \<15mL/min/1.73m2 at the time of screening
5. Weight ≥ 50kg
6. Serum alanine transaminase (ALT) within normal limits

Exclusion Criteria:

1. AB blood type
2. Body mass index (BMI \> 35
3. History of liver disease
4. Pregnant or nursing (lactating) women
5. Cardiomyopathy (LV ejection fraction \< 50%)
6. Positive crossmatch or positive donor specific antibodies
7. Human immunodeficiency virus (HIV) positive
8. Hepatitis C virus (HCV) RNA positive
9. Hepatitis B virus (HBV) surface antigen positive
10. Any contraindication to kidney transplant per MGH center protocol
A Study of LY3435151 in Participants With Solid Tumors

The reason for this study is to see if the study drug LY3435151 is safe in participants with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have certain types of cancer, which your study doctor will discuss with you
* Participant must have stopped other forms of treatment for cancer, which your study doctor will discuss with you
* Participant must be able and willing to provide a sample of your tumor before beginning treatment and once while on treatment. For certain tumor types, the outcome of the biopsy may exclude you from the study treatment (for Phase 1b)
* Participant must agree to use birth control
* Participant must have progressed through or are intolerant to therapies with known clinical benefit, which your study doctor will discuss with you

Exclusion Criteria:

* Participant must not have a history of tuberculosis, uncontrolled HIV or uncontrolled hepatitis B or C virus infection
* Participant must not have an autoimmune disease, which your study doctor will discuss with you
* Participant must not use corticosteroids, which your study doctor will discuss with you
* Participant must not have heart disease, Crohn's disease or brain cancer
* Participant must not be pregnant or breastfeeding
Incisional Hernia Progression Over Time

This is a prospective multicenter study of patients diagnosed with a medium to giant incisional hernia (transverse defect \>7 cm). Patients referred to the surgical outpatient clinic are invited to participate in the study. As a standard, all patients who are examined for incisional hernia undergo CT scan according to a hernia protocol, before planning of surgical repair (baseline scan). After this CT scan, patients are seen in the out-patient clinic once again and either treated conservatively without surgery, or scheduled for elective surgical repair of the hernia.

If surgery is planned, the patients participating in the study undergo an additional CT scan in hernia protocol, within two weeks prior to surgery (follow-up scan).

If a conservative non-surgical approach is chosen, patients can still participate in the study and will undergo an additional CT scan after 28-32 weeks.

This is a prospective multicenter study of patients diagnosed with a medium to giant incisional hernia (transverse defect \>7 cm). Patients referred to the surgical outpatient clinic are invited to participate in the study. As a standard, all patients who are examined for incisional hernia undergo CT scan according to a hernia protocol, before planning of surgical repair (baseline scan). After this CT scan, patients are seen in the out-patient clinic once again and either treated conservatively without surgery, or scheduled for elective surgical repair of the hernia.

If surgery is planned, the patients participating in the study undergo an additional CT scan in hernia protocol, within two weeks prior to surgery (follow-up scan). In case no baseline scan in hernia protocol exists, patients will undergo this scan immediately after inclusion in the study. Furthermore, patients will be asked to fill out a questionnaire on physical activity (IPAQ) and hernia-related quality of life (HerQLes) at the time of the baseline and follow-up scans. IPAQ is a well-validated questionnaire, which assesses patients' physical activity within the last 7 days. The outcome is metabolic minutes per week, a numerical value which places the responder in one of three categories: Low, moderate or high physical activity. HerQLes is a validated questionnaire assessing the hernia-related quality of life. This questionnaire has been translated into Danish using a standardized protocol. The outcome is a numerical score of 0-100, with 100 being the highest hernia-related quality of life. Currently, the time from planning of hernia repair to surgery is approximately 30 weeks. Thus, the mean time between the two CT scans should be around 28-32 weeks.

If a conservative non-surgical approach is chosen, patients can still participate in the study and will undergo an additional CT scan after 28-32 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Suspected incisional hernia with a horizontal fascial defect \> 7 cm

Exclusion Criteria:

* Inability to read or speak Danish
Futility of Exhaled Breath Condensate pH Measurements in Ventilated Patients in Intensive Care Unit (ICU)

Measurement of pH in Exhaled breath condensate has been mentioned as a robust variable from lung inflammation. It is non-invasive and reproducible. The investigators measured pH in the water condensed in the trap of expiratory arm of ventilator.In ICU the investigators measured pH in condensed water without interfering with patients treatment. A group of critically ill patients mechanically ventilated due to non pulmonary cause were followed until successful weaning, death or pneumonia. The investigators found that pH did not change along the study and it did not predict worsening condition.

Collection of exhaled breath condensate (EBC) became a promising method for obtaining samples from the lungs. In this prospective clinical trial we aimed to answer if spontaneous EBC in the trap of the expiratory arm of the ventilator could replace EBC collected by coolant chamber with gas standardization with Argon as an inert gas. Second, if EBC pH could predict ventilator associated pneumonia (VAP) and mortality. We included a group of critically ill patients, that required mechanical ventilation due to non-pulmonary cause. The patients were followed up until development of VAP, successful weaning or death.EBC pH spontaneously collected in the trap of expiratory arm of the ventilator. We measured pH with a blood gas analyzer, named Radiometer ABL5 Copenhagen. For the coolant chamber EBC pH measurement, the expiratory arm was passed through the chamber at -3ºC and in 10 min at least 2 ml was collected. The rest of the EBC was collected in Ependorff tube and pH was measured after de-aeration of the condensate with argon (350 ml/min) for 10 min as a gas standardization procedure as previously described by Hunt and colleagues. \[Hunt JF, Fang K, Malik R, Snyder A, Malhotra N, Platts-Mills TAE, Gaston B. Endogenous airway acidification: implications for asthma pathophysiology. Am J Resp Crit Care Med 2000; 161: 694-699. \]

Eligibility Criteria:
Inclusion Criteria:

* Endotracheal intubation and mechanical ventilation for at least 48 hours due to non-pulmonary cause
* For whom their close acquaintances gave the informed consent

Exclusion Criteria:

* Pregnancy, denied surrogate decision-makers to give informed consent.
* Patients that required mechanical ventilation due to: pneumonia, severe respiratory infection, massive haemoptysis, acute severe asthma, bronchiectasis, COPD exacerbation, or acute lung injury. Finally, patients that expected to be ventilated less than 2 days.
Treatment of Patients With RAD001 With Progressive Sarcoma

The purpose of this multicenter, three-arm, exact binomial single-stage, phase II trial is to determine the preliminary efficacy and safety of RAD001 in patients with histological evidence of progressive or metastatic bone or soft tissue sarcoma.


Eligibility Criteria:
Inclusion Criteria:

Histological evidence of progressive or metastatic bone or soft tissue sarcoma.

The following tumor types are included:

* malignant fibrous histiocytoma
* liposarcoma
* synovial sarcoma
* malignant paraganglioma
* fibrosarcoma
* leiomyosarcoma
* angiosarcoma including haemangiopericytoma
* malignant peripheral nerve sheath tumor
* STS, not otherwise specified
* miscellaneous sarcoma including mixed mesodermal tumors of the uterus
* osteosarcoma
* Ewing's sarcoma
* rhabdomyosarcoma
* gastrointestinal stromal tumor (only after failure or intolerance of imatinib or sunitinib in 1st and 2nd line)
* alveolar soft part sarcoma (ASPS)

  * Objective progression of disease may be documented by RECIST criteria. Any of the following would be sufficient according to RECIST:
* a 20% increase in the sum of unidimensionally measured target lesions
* a new lesion
* unequivocal increase in non-measurable disease.

  * Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent.
  * ECOG performance status 0 - 2.

Exclusion Criteria:

Anticancer therapy within 3 weeks of enrollment including chemotherapy, hormonal therapy, immunotherapy, or radiotherapy.

* The following tumor types will not be included:

  * gastrointestinal stromal tumor (except for patients after treatment with imatinib or sunitinib in 1st and 2nd line)
  * chondrosarcoma
  * malignant mesothelioma
  * neuroblastoma.
* Prior therapy with RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus).
* Neurotoxicity \> grade 2 CTC.
* Radiation of the lung.

Other protocol-defined inclusion/exclusion criteria may apply
Effects of Massage Therapy and Kinesthetic Stimulation on Pre-Term Infants

The purpose of this study was to determine whether massage with or without physical exercise impacted weight gain or length of hospital stay for premature infants.

Premature infants are often cared for in a fashion that minimizes physical activity in order to reduce stress and stress-related complications. Previous studies have indicated that massage therapy may increase weight gain and enabled earlier discharge of premature infants.

In this study, premature infants were randomly assigned to one of three groups:

A: Control Group

B: Massage Group, 15 minutes twice a day;

C: Massage and physical exercise group 15 minutes each, twice a day.

Eligibility Criteria:
Inclusion Criteria:

* low birth weight, less than 1500 grams
* weight of at least 1000 grams at time of entry into study
* must be at least one week of age
* must have relative medical stability
* gestational age between 28-32 weeks

Exclusion Criteria:

* infants with major congenital anomaly
* those that require mechanical ventilatory support
* those that are restricted in their movement or ability to undergo the intervention
Modulation of Fear Extinction Processes Using Transcranial Electrical Stimulation

The aim of this study is to examine the effects of transcranial electrical stimulation on processes associated with fear extinction in healthy humans.

Research links the processes of fear conditioning and extinction to the treatment of anxiety and stress-related disorders. Moreover, considerable translational research examines the neural correlates of these processes. However, virtually no research in humans manipulates neural correlates of these processes, which limits basic-clinical integration. The present study aimed to use transcranial electrical stimulation (tES) to modulate processes associated with fear extinction in order to assess the potential utility of tES in enhancing exposure-based treatment. To this end, healthy participants underwent a three-day fear conditioning and extinction paradigm. Participants were randomly assigned into 3 groups, differing in terms of tES applied during the extinction learning phase (Day 2) and targeting the medial prefrontal cortex: 1) direct current (DC) stimulation, aimed at enhancing extinction learning; 2) alternate current (AC) stimulation, aimed at interfering with reconsolidation of the fear memory activated during the extinction phase; and 3) sham stimulation. The outcome measures (outlined next) involve the assessment of extinction recall during a test phase (Day 3). Successful modulation of extinction learning by tES would be reflected in enhanced extinction recall.

Eligibility Criteria:
Inclusion Criteria:

Exclusion Criteria:

* Self-reported major psychiatric condition
* Screening specific for electrical stimulation (psychotropic medication, metal implants in head, epilepsy or seizure history)
An Open-Label Phase 1/2 Study to Assess the Safety, Efficacy and Dose of Study Drug UX003 Recombinant Human Beta-glucuronidase (rhGUS) Enzyme Replacement Therapy in Patients With Mucopolysaccharidosis Type 7 (MPS 7)

UX003-CL201 is an open-label Phase 1/2 study to assess the safety, efficacy, and dose of UX003 in MPS 7 patients via intravenous (IV) administration every other week (QOW) for 36 weeks with up to an additional 36 weeks from the optional continuation period. Up to 5 participants, who are between 5 and 30 years of age inclusive, will be enrolled and treated with UX003.

The initial 12-week treatment period will be followed by a 24-week forced dose titration period to assess the optimal dose. Participants who complete both the initial treatment and forced dose titration periods will continue treatment in a 36- week continuation period.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of MPS 7 based on leukocyte or fibroblast glucuronidase enzyme assay or genetic testing confirming diagnosis.
* Elevated urinary glycosaminoglycan (uGAG) excretion at a minimum of 2-fold over normal.
* Between 5 and 30 years of age, inclusive (approximately 2 subjects between the ages of 20-30 years).
* Willing and able to provide written, signed informed consent, or in the case of subjects under the age of 18 (or 16 years, depending on the region), provide written assent (if required) and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures.
* Sexually active subjects must be willing to use an acceptable method of contraception while participating in the study.
* Females of childbearing potential must have a negative pregnancy test at Screening and be willing to have additional pregnancy tests during the study. Females considered not of childbearing potential include those who have had tubal ligation at least one year prior to Screening, or who have had total hysterectomy.

Exclusion Criteria:

* Has undergone a successful bone marrow or stem cell transplant or has any degree of detectable chimaerism with donor cells.
* Any known hypersensitivity to rhGUS or its excipients that, in the judgment of the Investigator, places the subject at increased risk for adverse effects.
* Pregnant or breastfeeding at Screening or planning to become pregnant (self or partner) at any time during the study.
* Use of any investigational product (drug or device or combination) within 30 days prior to Screening, or requirement for any investigational agent prior to completion of all scheduled study assessments at any time during the study.
* Has a condition of such severity and acuity, in the opinion of the Investigator, that it warrants immediate surgical intervention or other treatment or may not allow safe study participation.
* Has a concurrent disease or condition that, in the view of the Investigator, places the subject at high risk of poor treatment compliance or of not completing the study, or would interfere with study participation or affect safety.
Effect of Tailored Preventive Program on Caires Incidence Using International Caries Classification and Management System (ICCMS) A Randomized Clinical Trial

This study will be conducted to evaluate The Effect of tailored preventive program on caries incidence using International Caries Classification and Management System (ICCMS) at a follow up periods of 3 ,6 and 12 months.

A total number of 144 high caries risk dental students were selected based on the applied caries risk assessment method (CAMBRA). In the study group they were given a preventive program as homecare program including tooth brushing 2/day with a fluoride toothpaste( 5000 ppm F) following the instructions in addition to fluoride mouth rinse. For the clinical approach motivational engagement was done by discussing with patients how to improve oral health behavior including amount of sugar, fibrous food and junk food. This in addition to pits and fissures sealant, F- varnish 2 times /year. Recalls up were done at 3, 6 and 12 months by recording the caries prevalence , application of fluoride varnish every 6 months and dietary intake interventions. In the Control group participants assigned to the control condition will be advised to maintain their existing lifestyles. For ethical reasons, if the program shows its effectiveness, it will be made available to all groups at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Dental student.
* No malocclusion.
* Medically free

Exclusion Criteria:

* Compromised medical history.
* Severe or active periodontal disease.
* Heavy bruxism or a traumatic occlusion