cyrilzakka/clinical-trials huggingface dataset:
Health Benefits of a 21-day Daniel Fast

The investigators hypothesized that individuals supplementing with krill oil capsules (two grams per day) would experience enhanced improvements in health-related variables during a 21-day Daniel Fast.

One of the main purposes of the this investigation was to determine if krill oil supplementation (two grams per day for 21 days) enhances the effects of a 21-day Daniel Fast, particularly in regards to blood lipids and lipid peroxidation. The investigators were also interested in determining if adiponectin and/or resistin change in response to the fast, as these adipokines could potentially mediate the favorable glucoregulatory changes the investigators observed in our initial investigation of a 21-day Daniel Fast. Finally, the investigators sought to determine the changes in macronutrient and micronutrient intake during a Daniel Fast, and how these dietary changes affect our selected hemodynamic, anthropometric, blood lipid, glucoregulatory, oxidative stress, inflammatory, renal, and hepatic biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age or older.
* Must be willing to partake in a vegan diet for 21 days.
* Must be willing to consume either krill oil or coconut oil capsules (assigned randomly).

Exclusion Criteria:

* Smokers
* regular consumption of antioxidant supplements
* women who were pregnant or seeking to become pregnant
* poor veins (veins that made it difficult to successfully obtain a blood draw - this was determined via a visual inspection)
The Safety, Immunogenicity and Immune Effect Research of the Varicella Vaccine After the 2nd Dose Vaccination

To investigate the safety, immunogenicity and immune effect of the Varicella vaccine after the 2nd dose vaccination in Chao yang district, Bei jing, since the 2nd varicella vaccination was promoted by Beijing Center for Disease Control and Prevention in November, 2012.

"Breakthrough" varicella cases and varicella cases were monitored to evaluate the protective effective in a large population.

Make the basic evaluation of safety for the two dose of varicella vaccination

Monitoring the Varicella virus origin and virus types from illness cases in Chao yang district

Make the evaluation of healthy costs reduce for the varicella emergency vaccination after large number of varicella cases occurred.

Eligibility Criteria:
Inclusion Criteria:

* Participants were between 4-12 years old
* Participants were in good healthy determined through medical history, physical examination, clinical judgment of the investor

Exclusion Criteria:

* Having a fever (axillary temperature \>37.0℃) before enrollment;
* Having a disease history of seizures, brain and mental disease and the vaccination history of allergies and convulsions;
* Antibiotics allergy;
* Having a problem of intramuscular injection because thrombocytopenia or other blood coagulation disorder;
* Having immunodeficiency or under immunosuppression therapy, radiation therapy;
* Having respiratory diseases, acute infection, chronic disease and HIV infection;
* Having systemic skin rash, skin tinea, herpes;
* Chronic liver and kidney disease;
* Heart disease, and severe hypertension;
* Have received whole blood, plasma or immunoglobulin therapy 3 months before enrollment;
* Have not received other vaccination in 7 days before enrollment
Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis

The aim of this study is to determine whether denosumab (an FDA-approved osteoporosis therapy), in combination with teriparatide (an FDA-approved osteoporosis therapy), will increase bone mineral density more than either one alone in postmenopausal osteoporotic women.


Eligibility Criteria:
Inclusion Criteria:

Must satisfy A and B and C and D below:

* (A) Women aged \> 55
* (B) Postmenopausal
* (C) Osteoporotic with high risk of fracture

Exclusion Criteria:

* Confirmed serum alkaline phosphatase above upper normal limit with no explanation
* Liver disease (AST or ALT \> 2 x upper normal limit).
* Renal disease (serum creatinine \> 2.0 mg/dl).
* Hypercalcemia (Ca \>10.5 mg/dL)
* Elevated blood PTH (intact PTH \> 65 pg/ml)
* Serum 25-OH vitamin D \< 20 ng/ml
* HCT \< 32%.
* History of malignancy (except basal cell carcinoma) or radiation therapy.
* Significant cardiopulmonary disease including unstable coronary artery disease, stage D ACC/AHA heart failure or any other condition that the investigator deems may preclude the subject from participating safely or completing the protocol procedures.
* Major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
* Excessive alcohol use or substance abuse that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
* Known congenital or acquired bone disease other than osteoporosis (including osteomalacia, hyperparathyroidism, Paget's disease)
* Current use or use in the past 6 months of oral bisphosphonate
* Current use or use within the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin.
* Use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months.
* Any current or previous use of strontium or any parenteral bisphosphonate.
* Known sensitivity to mammalian cell-derived drug products.
* Known sensitivity to teriparatide or any of its excipients.
Improving Representative Payeeship for People With Psychiatric Disabilities and Their Families

Representative payees, mostly family members, manage Social Security Administration funds of more than one million people with psychiatric disabilities. Although studies show payeeship can be used coercively, foster dependency, reduce work incentives, lead to family conflict and even violence, there has been little systematic research on how to lower these significant barriers to community integration.

The investigators' long term goal is to promote recovery among adults with psychiatric disabilities who have payees by reducing downsides associated with what has been called "the nation's largest guardianship system." The investigators' objective in the current application is to evaluate a pilot-tested, stakeholder-informed intervention that is grounded in principles of psychiatric rehabilitation and encourages consumers with psychiatric disabilities and their family members to collaborate within the representative payee arrangement.

To do this, we will test the Steps for Achieving Financial Empowerment (SAFE) intervention by randomly assigning N=200 consumer-family payee dyads into one of two groups: (a) the SAFE intervention (n=100); or (b) a "usual care" control (n=100). The SAFE is a brief, 5 component educational intervention that aims to facilitate a cooperative consumer-payee relationship, increase accurate knowledge about representative payeeship, promote collaborative money management and effective budgeting, and prepare mutually developed plans for carrying out the payeeship in the future.

We will interview people with psychiatric disabilities and their family payees at baseline and six-months. This study aims to examine the effects of the SAFE intervention on community participation, employment, and family support of adults with psychiatric disabilities who have family representative payees. Our central hypothesis, based on strong preliminary data, is that the SAFE will benefit consumers by enhancing autonomy, boosting motivation to work, and reducing family conflict.

Eligibility Criteria:
Inclusion Criteria:

* For disability recipients:

  1. Meets DSM-IV criteria for schizophrenia, schizoaffective disorder, bipolar disorder, or depressive disorder with psychotic features;
  2. age 18-65;
  3. Has a family member (parent or sibling) as a representative payee.
* For payees:

  1. Has family member (child or sibling) with schizophrenia, schizoaffective disorder, bipolar disorder, or depressive disorder with psychotic features; and
  2. Is the family member's representative payee.

Exclusion Criteria:

* None.
Fludrocortisone for Sudden Hearing Loss

The standard of care treatment of sudden hearing loss uses a type of steroid called glucocorticoid. Examples of glucocorticoids are prednisone, methylprednisolone and dexamethasone. Not everybody recovers hearing with glucocorticoid treatment. Fludrocortisone is a different type of steroid called mineralocorticoid. Unlike glucocorticoids, which work by reducing inflammation, mineralocorticoids work by changing salt and fluid balance. In animal studies, fludrocortisone is at least as effective as glucocorticoid in preserving hearing. Fludrocortisone is not approved for the treatment of sudden hearing loss. The purpose of this study is to test whether fludrocortisone can treat sudden hearing loss.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Idiopathic sudden sensorineural hearing loss within 3 months
* Failure to recover hearing with glucocorticoid treatment or inability to tolerate glucocorticoid

Exclusion Criteria:

* Other diagnosis for the sudden hearing loss
* Concurrent systemic use of another steroid
* Hypersensitivity to fludrocortisone
* Systemic fungal infection
* Hypertension requiring two or more medications
* Pitting edema
* Cardiomegaly
* Congestive heart failure
* Electrolyte abnormality
* Concurrent use of barbiturates, phenytoin, fosphenytoin, rifampin, or rifapentine
Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) Compared to Placebo in Migraine Prevention

To evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days, in adults with episodic migraine.

Adults with a history of migraine with or without aura for ≥ 12 months and who experience ≥ 4 to \< 15 migraine days per month with \< 15 headache days per month will be randomized 1:1 to placebo or erenumab. Double-blind erenumab or placebo will be administered during the 12-week double-blind treatment phase and open-label erenumab will be administered during the 28-week open-label treatment phase.

Eligibility Criteria:
Inclusion Criteria:

* History of migraines (with or without aura) for ≥ 12 months
* Migraine frequency: ≥ 4 and \< 15 migraine days per month on average acrossthe 3 months prior to screening
* Headache (ie, migraine and non-migraine headache) frequency: \< 15 headache days per month on average across the 3 months prior to screening
* Demonstrated compliance with the eDiary

Exclusion Criteria:

* Older than 50 years of age at migraine onset.
* History of cluster headache or hemiplegic migraine headache.
* Unable to differentiate migraine from other headaches
* No therapeutic response with \> 2 categories for prophylactic treatment of migraine after an adequate therapeutic trial.
* Concomitant use of 2 or more medications with possible migraine prophylactic effects within 2 months prior to the start of the baseline phase or during the baseline phase. If only 1 prophylactic medication is used, the dose must be stable within 2 months prior to the start of the baseline phase and throughout the study
* Used a prohibited medication, device, or procedure within 2 months prior to the start of the baseline phase or during the baseline phase.
* Received botulinum toxin
* Anticipated to require any excluded medication, device, or procedure during the study.
* Active chronic pain syndromes (such as fibromyalgia and chronic pelvic pain).
* History of major psychiatric disorder.
* History of seizure disorder or other significant neurological conditions other than migraine.
* Human immunodeficiency virus (HIV) infection by history.
* Myocardial infarction (MI), stroke, transient ischemic attack (TIA), unstable angina, or coronary artery bypass surgery or other revascularization procedure within 12 months prior to screening.
* The subject is at risk of self-harm or harm to others. Previously randomized into an AMG 334 study.
* Unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures.
Imaging for Significant Prostate Cancer Risk Evaluation

The incidence of prostate cancer is rising however the number of deaths from prostate cancer is stable. Meaning the investigators are diagnosing many men with prostate cancer that will not impact on their life. The rise in incidence is mainly due to increased use of the blood test Prostate Specific Antigen (PSA), as a screening test.

Currently men suspected of having prostate cancer, identified by a raised PSA undergo trans-rectal ultrasound guided prostate biopsy (TRUS biopsy). Many men have this test unnecessarily, only 1/3 being diagnosed with prostate cancer. TRUS biopsy is problematic as it is random and performed blind-the operator does not know where the cancer is. Thus many low-risk cancers that do not need treating are diagnosed and many high risk cancers are missed or incorrectly classified. So, men with a negative biopsy or those with low risk disease are usually advised to undergo another TRUS biopsy.

An imaging test is needed that could help men and their doctors decide whether the biopsy is a true reflection of what is inside his prostate.

The investigators will test the role of two imaging tests. The first, multi-parametric magnetic resonance imaging (mp-MRI) uses magnetic signals from the body to form images. The second, Prostate HistoScanning™ (PHS) uses sound-waves. The investigators will compare the results of these tests with a detailed biopsy map-transperineal template prostate mapping biopsy (which is currently the best way to find out what is in the prostate but requires multiple biopsies to be taken under general anaesthetic. Eligible men will have undergone one or more TRUS biopsies and who have been advised to have further tests on as part of standard of care. They will be recruited from UCLH referral letters and clinics.

The investigators aim is to see if either of these tests can confidently rule out the presence of clinically important disease.


Eligibility Criteria:
Inclusion Criteria:

* Men who have undergone prior trans-rectal biopsies.
* Men undergoing further evaluation of their prostate and who are seeking characterisation using Transperineal Template Prostate Mapping Biopsy.

Exclusion Criteria:

* Previous history of prostate cancer treatment
* Men unable to have MRI scan, or in whom artefact would reduce quality of MRI.
* Men unable to have general or regional anaesthesia
* Men unable to give informed consent
Pilot Study to Investigate The Diagnostic Yield and Utility of 22g and 19g Endobronchial Ultrasound Transbronchial Needle Aspirate

Needle biopsy samples are routinely collected to evaluate cytomorphology, immunohistochemical markers and for mutational analysis. With regular use of immunotheraputic interventions, needle biospy has become more frequent and requires bigger samples for an increasing battery of tests. There has been no clear consensus on which biopsy needle yields the best biopsy sample. It is unclear if large 19g needle offers better yield than a 22 g needle. Although previous studies comparing 21, 22 and 19g needles have suggested that larger needles yield larger biopsy sizes, conflictng studies have shown that larger biopsies lead to bloodier samples with potentially smaller fragments of tissue, offering no improvement in diagnostic, yield, adequacy or sample size.

This study compares biopsy samples collected using 19g and 22g needles from patients of non small cell lung cancer (NSCLC) scheduled to undergo endobronchial ultrasound (EBUS) and transbroncial needle aspiration (TBNA).

Primary Objective To compare the diagnostic yield of 22g and 19g EBUS transbronchial needle aspirate (TBNA)

Secondary Objectives

1. To compare the sample adequacy of 22g and 19g EBUS TBNA
2. To compare the sample quality of 22g and 19 g EBUS TBNA

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing EBUS TBNA for evaluation of lymphadenopathy, lung nodule or mass
* Patients must have atypical lymph nodes. Atypical lymph nodes are characterized by \>10mm in short axis or lymph nodes 5-10mm in short axis with atypical features.
* Age \> 18 years.
* Patients must have platelets count \> 50,000
* Ability to understand and willingness to sign a written informed consent and HIPAA consent document
* WOCBP must agree not to get pregnant until the day of the procedure

Exclusion Criteria:

* Patients with uncorrectable coagulopathy will be excluded.
* Patients with hemodynamic instability will be excluded
* Patients with refractory hypoxemia will be excluded
* Patients with therapeutic anticoagulant that cannot be held for 2 days before and 1 day after the procedure.
* Patients who are unable to tolerate general anesthesia according to the anesthesiologist
* Pregnant or breast feeding.
Hormone Therapy on Serum Ischemia Modified Albumin in Menopausal Women

Women suffer from cardiovascular diseases 10 years later than men, therefore female sex has been considered as a 'protective factor'. However, the risk of cardiovascular disease in women increases rapidly after menopause and the declining levels of endogenous estrogen is thought to be the causative factor. Furthermore, Postmenopausal hormone therapy (HT) decreases the severity and intensity of menopausal symptoms and improves women's quality of life. Until the last 10 years, based on the results of observational studies, postmenopausal HT may protect women against cardiovascular events and decrease the risk of coronary artery disease by 35-50%. However, recent randomized primary and secondary prevention trials did not support the cardioprotective effect of HT.

The aim of this study is to assess the effect of hormone therapy on serum ischemia modified albumin (IMA) levels. Thirty surgical menopausal women who admitted to Karadeniz Technical University, Faculty of Medicine, Department of Obstetrics and Gynecology during 1-year period and diagnosed as menopause and planned to have hormone therapy for menopausal symptoms were enrolled for this prospective study. The serum İMA levels were recorded before and after (3 months, 6 months, 12 months later) hormone treatment (2 mg Estradiol Hemihidrat).


Eligibility Criteria:
Inclusion Criteria:

* accepting consent to participate in the trial and signing the form
* Surgical menopausal women aged 45-55 (having TAH + BSO for benign reasons)
* Presence of vasomotor or menopausal symptoms (moderate to severe);
* no systemic disease or infectious disease in the past 2 weeks
* Not taking any other hormone therapy or medication until postoperative 6th week;
* no contraindications for hormone therapy in routine menopause evaluation;
* Willingness to take hormone therapy
* No smoking.

Exclusion Criteria:

* Any systemic disease presence
* Smoking
* Contraindications for hormone therapy
* Failure to follow-up
* Inability to complete three months of hormone therapy
* quitting hormone therapy for other medical reasons during hormone therapy
* Cases reported as preinvasive and invasive genital tumors as a result of TAH + BSO
* Cases reported as suspicious findings in the mammography report
Exercise Rehabilitation in Veterans With PAD

Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) and decreased blood flow to the legs. This may cause difficulty or pain with walking or other activities that use leg muscles. Exercise may help improve blood flow in the legs and improve the ability to walk. This research project will be conducted patients with PAD that require revascularization. The goal is to examine the effects of 3 months of exercise rehabilitation or neuromuscular stimulation on leg blood flow, physical function, quality of life and general health.

Peripheral artery disease (PAD) and its associated declines in physical function impair quality of life (QOL) in nearly 20% of older Veterans and result in substantial VA health care costs. Revascularization addresses the anatomical pathology, but does not restore mobility function and QOL. Optimal therapy may require post-revascularization rehabilitation to address lingering defects in skeletal muscle that limit function; however, the current standard of care after revascularization does not include rehabilitation. Exercise training and neuromuscular electrical stimulation (NMES) may enhance function by increasing muscle perfusion to improve outcomes in older Veterans with PAD after revascularization.

The investigators will enroll Veterans (50-80 years of age) with PAD who are planned for percutaneous revascularization. Participants will complete research testing consisting of: a) Assessment of mobility function and QOL; and b) Treadmill tests to assess ambulatory capacity, and calf muscle perfusion. Participants will undergo screening prior to revascularization and will have baseline testing 2-3 weeks after revascularization. After post-revascularization testing, patients will be randomized to Exercise-only or NMES-only. After completion of the 3-month intervention, participants will repeat all tests to determine the effects of the interventions.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of peripheral arterial disease; or ankle-brachial index \<0.9.
* Planned to undergo endovascular revascularization within 6 months.

Exclusion Criteria:

* Cancer under active treatment
* Planned for lower extremity bypass surgery
* Body mass index \> 45 kg/m2
* Critical limb ischemia or lower extremity gangrene
Prevalence of Hypomineralized Second Primary Molars and Their Association with Dental Hypersensitivity in Egyptian Children

hypomineralized second primary molars and dental hypersensitivity in a group of Egyptian children

the prevalence of the condition of hypomineralized second primary molars in a group of Egyptian children and the association of this condition to dental hypersensitivity.

Eligibility Criteria:
Inclusion Criteria:

* Egyptian children
* cooperative patients both genders and included 4-9 years old children at least one HSPM affected molar and one non affected molar absence of syndromes or craniofacial anomalies

Exclusion Criteria:

* other developmental defects(amelogensis imperfecta ...) children ongoing anti-inflammatory drugs children who caregiver will not sign the informed consent
Role of Radiotherapy Following Oesophageal Stenting in Cancer

To assess the benefits of oesophageal stenting and external beam radiotherapy over oesophageal stenting alone in patients with inoperable oesophageal cancer

A majority of patients with oesophageal cancer present with inoperable disease and require rapid and long lasting palliation of dysphagia.

STUDY AIM: To compare dysphagia relief in patients treated with oesophageal stenting and external beam radiotherapy (EBRT), versus oesophageal stenting alone and to assess overall survival, treatment related complications, and quality of life in the two groups.

PATIENTS AND METHODS: Patients with inoperable oesophageal cancer with high grade dysphagia to be randomised to receive oesophageal stenting alone (Group I), versus a combination of stenting followed by EBRT (Group II). Dysphagia relief, treatment related complications, overall survival, and quality of life to be assessed in the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Oesophageal cancer patients with locally advanced unresectable cancer (such as invasion of tracheo-bronchial tree, aorta, pulmonary vascular structures, etc),
* Metastatic disease, and co-morbid conditions precluding major surgical procedure (such as severe cardiopulmonary, hepatic and renal diseases) with grade 3 and 4 dysphagia, were included in the trial.

Exclusion Criteria:

* Patients with carcinoma of the cervical oesophagus and those who had already received prior radiotherapy, chemotherapy, or any other modality of treatment were excluded