cyrilzakka/clinical-trials huggingface dataset:
Enzalutamide Before Surgery in Treating Patients With Kidney Cancer

This pilot phase 0 trial studies how well enzalutamide works before surgery in treating patients with kidney cancer. Androgens are a type of hormone produced by the body that may cause kidney tumors to grow. Anti-hormone therapy, such as enzalutamide, may lessen the amount of androgens produced by the body and keep kidney tumors from growing.

PRIMARY OBJECTIVES:

I. To investigate the effects of neoadjuvant enzalutamide on clear cell renal cell carcinoma (ccRCC).

OUTLINE:

Patients receive enzalutamide orally (PO) daily for 90 days in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy.

After completion of study treatment, patients are followed up every 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Clinical T1N0M0 (=\< 7 cm) renal mass as measured on cross-sectional imaging (computed tomography \[CT\] or magnetic resonance imaging \[MRI\])
* Biopsy proven ccRCC
* Tumor with androgen receptor (AR) expressed \>= 4580 copies/ug ribonucleic acid (RNA)
* Can provide informed consent
* Adequate hepatic function (\>= 1.5 x upper limit of normal \[ULN\]; patient's with Gilbert's disease are not excluded)
* Adequate renal function (estimated glomerular filtration rate \[GFR\] \> 40mL/min)
* No evidence of metastatic disease on baseline imaging (chest x-ray \[CXR\] or chest CT, abdominal CT or MRI)
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2

Exclusion Criteria:

* Prior use of androgen deprivation including enzalutamide
* Pregnant women or women who are of child bearing age who are not willing to use two (2) forms of contraception during treatment with enzalutamide and for six (6) months after treatment
* Men must use adequate methods of contraception during and at least 3 months after treatment if engaging in sexual activity with a female of child bearing age
* Known hypersensitivity to enzalutamide
* History of unprovoked deep vein thrombosis/pulmonary embolism (DVT/PE) in past twelve (12) months
* Inability to stop anticoagulants/antiplatelet therapy peri-operatively
* History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma)
* History of loss of consciousness or transient ischemic attack within twelve (12) months of enrollment
* Any unstable, serious co-existing medical conditions including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within twelve (12) months prior to screening
* Known or suspected brain metastasis or active leptomeningeal disease
* Current use of exogenous testosterone
* Retroperitoneal/hilar adenopathy concerning for locally advanced disease
* Metastatic RCC
Conducting Annual Asthma Reviews Using Telehealthcare: Comparison With Standard Care (Face-to-face Consultations)

The National Report of Asthma Deaths published in 2014 highlighted significant deficiencies in both primary and secondary care resulting in one of the highest mortality rates in Europe. A key recommendation in the report is the provision of an annual asthma review in primary care.

Telehealthcare is an alternative means of service delivery incorporating the use of telephone and e-mail consultations which may improve access and quality of patient care. There is scant data on the role of teleheathcare in asthma care.

This is a single-centre, primary care-based, randomized controlled trial to evaluate the use of telehealthcare to conduct the annual asthma review for adult patients with well-controlled asthma. This will be compared with standard care (face-to-face consultations).

Telehealthcare will consist of a telephone consultation followed by an e-mail with an attached personalised asthma action plan and a link to a video demonstrating inhaler technique.

Standard care will involve a face-to-face consultation in primary care. The two patient groups will be compared prospectively to determine whether there is a difference in the quality of care evaluated in terms of the patient experience/ satisfaction, health-related quality of life, asthma control and frequency of asthma exacerbations over a 6 month period after the asthma review.

The data will be presented in the form of frequency tables, bar charts and pie charts. Non-parametric tests will be applied to determine whether there is a significant difference in the quality of care received.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and over, registered at Balham Park Surgery
* Patients diagnosed with asthma (patients on the asthma register)
* Patients with well-controlled asthma (ACT score 20 and over; no out of hours/ A\&E attendances/ PO steroids/ hospital admissions since the last asthma review in primary care)

Exclusion Criteria:

* Patients aged less than 18
* Patients with poorly controlled asthma (ACT score 19 or less; out of hours/ A\&E attendance/ hospital admission/ PO steroids since last asthma review in primary care)
* Patients with a mental health diagnosis
* Patients without an up to date contact telephone number or with communication difficulties that would prevent or restrict their use of the technology.
30-Day Trial of Oral Valtrex or Valtrex Plus Aspirin on Shedding of HSV DNA in Tears and Saliva of Volunteers

The purpose of this study is to determine whether oral Valtrex alone or in combination with aspirin will reduce the shedding of herpes simplex virus DNA in the tears and saliva from volunteers with no evidence of ocular herpes infection. The secretion of virus into the tears and saliva might make people more susceptible to virus infection in the future if their immune system becomes deficient. The study will also try to determine if there is a correlation between shedding of viral DNA and herpes virus antibodies in serum and to determine if subjects are carriers of a special form of a gene in their blood cells, the presence of which may suggest the possibility of an increased susceptability to herpes and to Alzheimer's disease and heart disease.

Published studies have shown that treatment with oral acyclovir reduced clinical recurrences of ocular herpetic keratitis by about 40-50 %8, and treatment with valacyclovir, a more soluble prodrug of acyclovir, reduced the risk of transmission of genital herpes9, 10, 11. For this study, we will use the dose of valacyclovir that was shown effective in reducing the risk of transmission of HSV-2.9 The dose of 325 mg aspirin three times a day was chosen based on our experience with mice and other laboratory animals12. If it is effective and well tolerated at this dose, in future studies we will attempt to use lower doses and determine if they too may be effective.

Eligibility Criteria:
Inclusion Criteria:

* either sex
* any race
* over age of 21 years

Exclusion Criteria:

* have active ocular herpetic lesion
* had ocular herpetic lesion in past 30 days
* taking systemic or oral antiviral drugs
* have taken antiviral drugs in the past 30 days
* taking aspirin or NSAIDs
* have dry eyes
* have hypersensitivity to acyclovir or valacyclovir
* have hypersensitivity of contraindication to use of aspirin
* have bleeding disorder
* have GI ulcer
* have kidney impairment
* are pregnant or nursing
* have participated in a clinical trial in the past 30 days
Defining Inflammation Related to Peritoneal Carcinomatosis in Women With Ovarian or Colon Cancer.

Inflammation plays an important role in the pathogenesis of peritoneal carcinosis. Patients with elevated levels of different inflammation cytokines show a worse prognosis at the time of diagnosis. In women, ovarian and colon cancer are the main causes of peritoneal carcinosis and a comparison of these two different types of peritoneal invasion have not been conducted yet. We found interesting studying the role of immune response, in particular tumour-associated antigens (TAA) that modulate the metastatic process. We will investigate also mitochondrial defects, such as mutations in mt-DNA, potentially involved in carcinogenesis.

At the time of hospitalization all the patients will undergo a complete clinical evaluation with determination of biochemical parameters such as fasting blood glucose, blood count, hs-CRP, AST and ALT, uric acid, creatinine and BUN. An extra blood aliquot will be collected to assess the serum biomarkers under investigation.

During surgery two samples of peritoneal tissue macroscopically undamaged will be collected. On those samples will be executed separation of adipocytes cells, RNA and protein extraction for measuring of inflammatory and neoplastic biomarkers, determination of P2X7R-inflammasome activity and mitochondrial DNA analyse.

Eligibility Criteria:
Inclusion Criteria:

* histological diagnosis of peritoneal carcinosis secondary to colon cancer or high-grade ovarian cancer
* patients able to consent

Exclusion Criteria:

* previous malignancies, except for patients with cutaneous basal cell carcinoma, Cervical Intraepithelial Neoplasia (CIN) or melanoma in situ
* current chemotherapy or radiotherapy
* current steroid therapy or immunotherapy
* patients affected by systemic inflammatory disease and/or Inflammatory bowel disease (IBD)
Psychological Impact of Medical Evacuations on Families of Patients Admitted to Intensive Care Unit for Severe COVID-19

At the "Métropole Savoie" hospital, to deal with the daily influx of severe patients during the second wave of COVID-19, 23 patients had to be transferred away from their home city and far from their families as part of a medical evacuation (EVASAN).

The purpose of the study is to investigate whether there is an association between medical evacuations and the occurrence of psychological disorders such as post-traumatic stress, anxiety or depression occurring within 6 to 10 months in families of evacuated patients.

The investigators want to compare the prevalence of psychological disorders in the families of patients evacuated for a serious form of COVID-19 (cases) compared to that of families of patients not evacuated (controls) hospitalized for a serious form of COVID-19.

The case group is trusted person of evacuated patient. The control group is trusted person of not evacuated patient.

The trusted person of the group control will be matched to trusted patient of the case group on :

their relationship with the patient (spouse/ascendant/descendant/other) and on criteria specific to the patient: sex, age range ( \<75 years or ≥ 75 years), invasive ventilation and becoming at 3 months post COVID-19 (survivor / non survivor)

Eligibility Criteria:
Inclusion Criteria:

Trusted person of patients admitted to the Adult Intensive Care Unit (ICU) of the "Metropole Savoie"hospital

* during the second wave of COVID-19 in France
* for a serious form of COVID-19
* hospitalized more than 72 hours in ICU

the case group is trusted person of evacuated patient. the control group is trusted person of not evacuated patient.

Non -inclusion criteria :

Trusted Person Refusing patient Medical Evacuation
Olanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified(OL Study)

Determine the efficacy and tolerability of olanzapine for treatment of acute depression in patients with bipolar II or bipolar disorder NOS compared with lithium.


Eligibility Criteria:
Inclusion Criteria:

* major depressive episode in type2 bipolar disorder or bipolar disorder NOS.(MADRS more than 20 point)
* 18years to 65years
* subjects who sign the informed consent document

Exclusion Criteria:

* don't have Diabetes and abnormal metabolism of sugar
* not noticed as bipolar disorder
* have an organic brain disease
* pregnant or breastfeeding women
* don't have heart disease
* have actively suicidal thought(Suicidal ideation score of MADRS is 6)
* who are judged by the investigator to should be excluded from the study
Adiposity and Endothelin Receptor Function

Elevated levels of ET-1 have been implicated in cardiovascular disease and some forms of hypertension. Due to the strong, positive correlation between obesity and hypertension, the present study will explore the contribution of adiposity in ETB receptor function and aim to elucidate if ETB receptor dysfunction is a major contributor to hypertension in obesity.

The proposed study is designed to investigate the influence of adiposity on ETB receptor function and subsequent vascular responses. The combination of ET-1, ET-3, and the respective ETA and ETB receptor antagonists will be used to provide insight into the mechanisms of ETB receptor dysfunction in the presence of adiposity. Previous studies have revealed elevations in circulating ET-1 in obese individuals; therefore, we predict that obese subjects will exhibit 1) ETB receptor dysfuncton compared to lean subjects and 2) an improvement in ETB receptor dysfunction following treatment with Candesartan.

Eligibility Criteria:
Inclusion Criteria:

• If you are an adult between the ages of 18-40 year old

Exclusion Criteria:

* Evidence of cardiovascular, pulmonary, renal, hepatic, cerebral, or metabolic disease
* Evidence of pregnancy
* Using medications that affect vascular tone (i.e., nitrates, etc.)
* Use of any anticoagulants (i.e. aspirin)
* Anemia
* If you are postmenopausal
* If you have uncontrolled hypertension (treated resting SBP \>140 mm Hg or DBP \>90 mm Hg)
Reproducibility of Blood Flowmetry in Human Retina Using the Nidek Laser Speckle Flowgraphy LSFG-NAVI System

In addition to intraocular pressure blood perfusion pressure in the optic nerve is an important factor determing the cause of glaucoma. Increasing evidence suggests that in glaucoma patients retinal blood may be decreased.

According to the World Health Organization (WHO) glaucoma is the second leading cause of blindness. Glaucoma is a global problem, which is becoming even more important as the human life expectancy increases. Although the causes of glaucoma are uncertain, mainly intraocular pression (IOP), genetics, and ocular blood perfusion pressure in the optic nerve determine the cause of the disease. Increasing evidence suggests that in glaucoma patients retinal blood flow is decreased leading to progression and to damage of the optic nerve.

In order to measure the peripapillary blood flow a variety of devices using different techniques of flowmetry have been developed. In this study, the reproducibility of the retinal flowmetry measured with the LSFG-NAVI device from Nidek will be investigated. A high reproducibility is crucial for the clinical value of any measuring device.

Eligibility Criteria:
Inclusion Criteria:

* signed Patient Informed Consent form
* Be at least 18 years old
* Diagnosis of primary or secondary open-angle glaucoma or normal tension glaucoma or healthy controls

Exclusion Criteria:

* Age \< 18 years
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
* No vulnerable participants will be included in this study.
Tetrandrine Tablets Used in Hospitalized Adults With COVID-19

The primary objective of this study is to evaluate the effectiveness of tetrandrine tablets in preventing the progression of COVID-19 from severe to critical.

The primary objective of this study is to evaluate the effectiveness of tetrandrine tablets in preventing the progression of COVID-19 from severe to critical. The secondary objective is to evaluate the clinical indicators of COVID-19 with tetrandrine tablets treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Sign informed consent form voluntarily for the trial.
2. Male or female aged between 18 and 85 years (inclusive).
3. Clinically or laboratory confirmed COVID-19 within the past 7 days, as determined by a positive RT-PCR test or a positive antigen test.
4. Under resting conditions, oxygen saturation ≤93% when breathing air, or P/F value ≤ 300 mmHg (1 mmHg = 0.133 kPa).
5. No birth plan and must agree to take effective contraceptive methods.

Exclusion Criteria:

1. Received a vaccine within 4 weeks prior to the study, or plan to receive a vaccine during the study period, or received treatment with tetrandrine tables prior to enrolling in the study.
2. Patient must be on invasive mechanical ventilation/ECMO at baseline.
3. Any clinically important serious diseases unstable or uncontrolled.
4. Allergy history to any biological or other agent.
5. Patient has severe mental or psychological abnormalities, cognitive impairment or intellectual disability before being diagnosed with COVID-19.
6. Subjects who are pregnant or breastfeeding, or plan to become pregnant during the study.
7. Investigator think the subject should not participate in the study.
Effect of Vitamin D Supplementation on Bone Turnover Markers During PrEP in MSM

CCTG 595 is an open-label clinical trial of the effect of a text messaging intervention vs. standard of care on adherence to Truvada as PrEP in MSM at increased risk for HIV infection (ClinicalTrials.gov Identifier: NCT01761643). Eligible subjects for this matched case control substudy will receive vitamin D 4000 IU/day for 24 weeks, from week 24 through week 48. In CCTG 595, plasma from participants are being collected and stored at entry and every 12 weeks. These plasma samples will be used to measure P1NP, CTX, PTH, and vitamin D levels in both cases and controls at entry, week 24, and week 48.

A total of 50 HIV-uninfected men who have sex with men (MSM) and male to female (M to F) transgender individuals already enrolled in CCTG 595 will be offered participation in the sub-study at Week 24 of the main study. All subjects enrolled into the sub-study will be provided Vitamin D 4000 IU/day supplements in addition to their PrEP at Weeks 24 and 36; clinic visits will proceed normally per main study protocol. Upon completion of the sub-study subjects will continue on the main study.

The primary endpoint, bone turnover markers, will be measured from Week 24 to Week 48 via plasma samples collected through the main study. Concurrent controls who are not enrolled in the vitamin D substudy who are reporting supplementation with \< 400 IU of vitamin D/day will be matched 1:1 by randomization arm in the CCTG 595 main study (text messaging arm vs. standard of care), age (± 5 years), race/ethnicity, season of study entry, and BMI (± 3 kg/m2).

Eligibility Criteria:
Inclusion Criteria:

* All subjects must meet CCTG 595 inclusion criteria.

Exclusion Criteria:

* All subjects must meet CCTG 595 exclusion criteria.
* Current or prior use of bisphosphonate therapy.
* Current use of Vitamin D supplements greater than 400 IU/day.
* Current use of androgenic hormones or growth hormones.
* History of nephrolithiasis (kidney stones).
* History of fragility fracture.
* No use of tenofovir prior to entry into CCTG 595
Detection of Pulmonary Embolism With CECT

To compare the vascular enhancement of the two contrast agents in pulmonary Multi-detector CTA


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 yrs or older
* With suspected PE
* Referred for MDCTA of pulmonary arteries
* Signed informed consent

Exclusion Criteria:

* Pregnant and lactating females
* History of hypersensitivity to iodinated contrast agents
* Hyperthyroidism or pheochromocytoma
* Severe CHF
* Renal impairment
* Weight greater than 300 lbs
* Pacemaker
* Swan Ganz catheter
* Defibrillator or other intrathoracic metallic vascular device
* Received an investigational compound within 30 days of being in the study
Obstetric and Neonatal Outcomes of Twin Pregnancy

This multicenter study aims at assessing the natural history of twin pregnancy and developing a machine learning-based algorithm to predict clinical outcomes of twin pregnancy during pregnancy and delivery and to determine management strategies that are associated with best maternal and neonatal outcomes. This study will include at least 12 centers from different countries that present at least Europe, South America, Asia, and Africa. Data will be retrospectively collected from January 1st, 2010 to December 31st, 2019.

Twin pregnancies carry higher risks of maternal, fetal and neonatal adverse outcomes compared to singleton pregnancy.They are associated with increased perinatal morbidity and mortality, anemia, pregnancy- induced hypertension, increased incidence of cesarean section (CS), postpartum hemorrhage, prematurity and low birth weight and Increased rate of perinatal death.

This multicenter study aims at assessing the natural history of twin pregnancy, and developing a machine learning-based algorithm to predict clinical outcomes of twin pregnancy during pregnancy and delivery and to determine management strategies that are associated with best maternal and neonatal outcomes.

Medical records of eligible women will be reviewed, and data abstraction will be performed using a standardized excel sheet designed for this study. Target data include baseline demographics and clinical data (e.g. age, parity, ethnicity, smoking, IVF pregnancy, history of gynecologic surgeries, type of twin pregnancy, current medical disorders, current obstetric complications, fetal anomalies, administration of antenatal steroids, Placental site, and twin-specific complications). Information from serial ultrasound reports including fetal growth and Doppler studies will be collected and data on fetal intervention will be abstracted. Peripartum data include node of delivery, Method of induction, CS indication, and type of cesarean incision. Clinical outcomes include postpartum hemorrhage, and perinatal death, admission to neonatal intensive care unit (NICU), neonatal need for respiratory support, neonatal intracranial hemorrhage, neonatal respiratory distress syndrome and neonatal hypoxic ischemic encephalopathy. Data will not include any identifiable information.

Prediction model will be created using baseline demographic and obstetric features of pregnancy and individual maternal and perinatal complications will be set as outcomes (dependent variables). A composite outcome of major maternal and neonatal outcomes will be created separately.

Eligibility Criteria:
Inclusion Criteria:

1. Women with twin pregnancy who received their antenatal care and were delivered in the participating institute
2. Compliance to antenatal care visits

Exclusion Criteria:

1. Major fetal anomalies of one or both twins
2. Elective miscarriage
3. Authorization to use medical records was not provided by the patient