cyrilzakka/clinical-trials huggingface dataset:
Antioxidant Supplement and Reduction of Metachronous Adenomas of the Large Bowel: a Double Blind Randomized Trial

The trial was aimed at evaluating the efficacy of a multiagent antioxidant compound (vitamin A, C, E, selenium and zinc) in reducing the incidence of metachronous adenomas of the large bowel after endoscopic polypectomy. This is a randomized study: a 50% reduction in the incidence of metachronous adenomas was expected in patients allocated to the "active" compound (intervention) arm as compared to those assigned to a placebo.

Adenomatous polyps (or adenoma) are benign lesions of the large bowel that are frequent in people aged 60 or more: about one in four of them has at least one adenoma. In time, adenoma could progress to cancer. Even though only a small rate of adenomas will develop into cancer almost 70-80% of colorectal cancer origin from an adenoma and colorectal cancer is one of the most frequent malignant tumors in the western world. Several epidemiological studies showed that subjects who had low intake and/or low blood levels of selenium were at increased risk of developing colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* age 25-75 years
* at least one histologically confirmed adenoma endoscopically removed from the large bowel resulting in a polyp-free colon-rectum (clean colon).

Exclusion Criteria:

* polypectomy performed more than 6 months before enrolment in the trial
* history of Familial Adenomatous Polyposis
* inflammatory bowel disease
* adenoma with invasive carcinoma
* ten or more adenomas
* large sessile adenoma (3 cm or more
* colorectal resection
* invasive cancer at any site
* life-threatening and/or chronic heart, liver or kidney diseases
* current use of vitamin or calcium supplements
* mental disability
Digitally Assisted Recovery Coach

The aims of this proof-of-concept study are to determine the feasibility of 1) using a smartphone app ("Lifeguard") to facilitate engagement with a peer recovery coach, 2) monitoring post-detox using a modified Brief Addiction Monitor, and 3) assessing linkage to care post-detox.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 to 65
* Diagnosis of DSM-5 alcohol use disorder
* Admitted to Brigham and Women's Faulkner Hospital (BWF) inpatient Addiction Recovery Program to treat alcohol withdrawal
* Own either an iOS or Android smartphone device
* Have an active email address
* English speaking

Exclusion Criteria:

* Inability to provide informed consent due to delirium or other cognitive impairments
* Current psychosis, suicidality or homicidality
Effect of Probiotics on Mycoplasma Pneumoniae Pneumonia

To evaluate the effectiveness and safety of compound probiotic in shortening the course of illness in children with mycoplasma pneumoniae pneumonia, in comparison with placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria for pneumonia in "Zhufutang Practical Pediatrics" (7th Edition), and is diagnosed with Mycoplasma pneumoniae pneumonia using tNGS technology;
2. Infants and young children aged 6 months to 3 years;
3. The course of the disease is \<48 h;
4. The family members of the children are informed about the study and sign the informed consent form.

Exclusion Criteria:

1. Previous history of wheezing;
2. Cardiovascular disease and congenital tracheal dysplasia;
3. pneumonia induced by other causes;
4. Dysplasia of bronchial and pulmonary tracts;
5. premature infants;
6. Combined with immunosuppressive diseases;
7. Presence of mental illness.
Saliva Insulin as Biomarker of Risk Factors for Metabolic Dysregulation and Caries

Saliva insulin shows promise as a non-invasive biomarker of high carbohydrate intake and/or insulin resistance, key risk factors for metabolic dysregulation and caries.

Saliva insulin monitoring could potentially inform the planning and evaluation of interventions to prevent child obesity, diabetes and caries, without relying on self-reported measures from children, parents, child care providers or teachers.

School-based public health screening programs, which have staff and data collection infrastructure in place to regularly and systematically collect saliva during oral health screening, have opportunity to monitor saliva insulin.

This randomized controlled trial explores if saliva insulin is responsive to the kinds of obesity and caries intervention currently in progress in schools, namely drinking water intervention. Public health programs may justify adding saliva collection to protocol already in place if saliva insulin data are found to be actionable, i.e. sensitive to risk and intervention.

This randomized controlled trial explores if saliva insulin is responsive to the kinds of obesity and caries intervention currently in progress in schools, namely drinking water intervention.

The specific aims of this randomized controlled trial are to:

Determine if the standard serving (500 ml) of drinking water normalizes saliva insulin to a greater extent, within 60 min, than no beverage or a standard serving (200 ml) apple juice in elementary school age children.

Determine if, in line with lower saliva insulin, 500 ml drinking water significantly alters macronutrient metabolism, within 60 min, relative to no beverage or 200 ml apple juice.

Determine if 500 ml drinking water reduces caries risk factors, improves saliva osmolality, pH, buffering capacity and immune response to a greater extent, within 60 min, than no beverage or 200 ml apple juice.

Eligibility Criteria:
Inclusion Criteria:

UCSF Pediatric Dental Clinic patients New patient exam or recall exams Caregiver and child speak English, Spanish or Chinese Ages 5-10 years San Francisco residents Non-acutely ill (healthy enough to attend school, no fever and no systemic conditions)

Exclusion Criteria:

Child and caregiver do not speak English, Spanish or Chinese Not a San Francisco resident Under age 5 years Over age 10 years Child unwilling to accept randomized drink assignment Child unable or unwilling to drink water or apple juice Child unable or unwilling to give saliva Child is presenting to the dental clinic for an operative procedure Acute illness, fever, infection or condition that would prevent the child from attending school No remaining space in study group (weight-specific recruitment is complete).
Comprehensive Add on Study in Japan

The objective of the current study is to investigate the safety and efficacy of linagliptin (5mg / once daily) given for 52 weeks as add-on therapy to patients with type 2 diabetes mellitus and insufficient glycaemic control despite diet, exercise, and treatment with one approved antidiabetic drug.


Eligibility Criteria:
Inclusion criteria:

1. Diagnosis of type 2 diabetes mellitus
2. Male and female patients on diet and exercise regimen who are treated with one antidiabetic drug

Exclusion criteria:

1. Myocardial infarction, stroke, transient ischemic attack, or pulmonary embolism
2. Impaired hepatic function
3. Glitazone, glinide, and sulfonylurea group: renal failure or renal impairment defined as estimated glomerular filtration rate \<30 ml/min (severe renal impairment) at Visit 1, Biguanide group: renal failure or renal impairment defined as estimated glomerular filtration rate \<60 ml/min (moderate renal impairment) at Visit 1
4. Treatment with anti-obesity drugs
rATG Versus rATG Combined With Intravenous Immunoglobulin (IVIG) Induction Immunosuppression in HLA Incompatible Transplantation (INHIBIT)

This study aims to prove similar efficacy of PE/rATG (intervention) and PE/rATG/IVIG (centre standard of care) induction regimens to prevent biopsy proven antibody-mediated changes and TCMR as composite endpoint within 12 months after HLA incompatible kidney transplantation.

There have been no published clinical studies evaluating rATG/IVIG induction protocol in comparison with rATG alone in defined cohort of HLA incompatible kidney transplant recipients. Prescribing IVIG in management of prevention of transplant rejection is considered off-label use, however IVIG remains part of induction protocols in many transplant centres. IVIG therapy is demanding due to high cost and limited resources of these human origin products. Trial participants will be end-stage renal disease (ESRD) patients listed for deceased donor / living donor kidney transplantation with anti HLA antibody screening performed within 12 months before transplantation and with last DSA 1 000 - 5 000 Mean Fluorescence Intensity (MFI) and negative CDC (Complement-dependent cytotoxicity crossmatch test) prior to transplantation. Participants will be randomized into one of the treatment groups (PE/PP(Plasmapheresis) + rATG + IVIG, PE/PP + rATG) and as a primary outcome a composite endpoint defined as occurrence of antibody- or T-cell mediated rejection within 12 months after transplantation will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Primary deceased donor or living donor kidney transplantation (first transplantation or re-transplantation)
* Recipient age ≥ 18 years and \< 70 years
* Donor age \< 70 years
* Written Informed Consent and Consent for Processing Personal Data
* Last anti-HLA screening no longer than 12 months with positive results
* MFI DSA 1 000 - 5 000 (anti-HLA A, B, DR), MFI DSA 1000-15000 for anti DQ when available at randomization)

Exclusion Criteria:

* Combined kidney transplantation with another organ
* Immunosuppressive therapy up to 6 months before transplantation
* AB0i (AB0 incompatible) transplantation
* Women in childbearing potential without adequate contraception
* HIV positivity
* Leukopenia \< 3 000, thrombocytopenia \< 75 000
* Tuberculosis history
* Anti-HCV (Hepatitis C Virus) positivity, HBsAg (Hepatitis B Surface Antigen) positivity or HBV (Hepatitis B Virus) DNA positivity
* DSA (anti A, B, DR) measured by Luminex with MFI \> 5 000 known at screening prior to transplant, anti DQ \> 15000 if known
* FACS (flow-cytometry) T and B crossmatch positivity known at screening prior to transplant
* Positive CDC prior to transplantation
* Planned PP/PE and RTX (Rituximab) treatment post-transplant
* Advanced liver disease (Child-Pugh C or laboratory values of ALT or AST more than 3 times upper limit of normal range)
* Pregnancy, breastfeeding
* Study medication is contraindicated according to the SmPC
* Patient is enrolled in other clinical trial
Understanding HIV Susceptibility in the Female Genital Tract

There is great variability in susceptibility from one person to another, and less than one in a hundred sexual exposures to HIV results in infection. In addition, some recent trial of methods to prevent HIV - including vaccines and microbicides - have actually increased HIV acquisition among trial participants for reasons that we do not fully understand. While we know that immune differences in the genital lining are an important determinant of whether a person is infected after a sexual HIV exposure, we don't know enough about these differences to be able to accurately assess a person's individual HIV risk. Therefore, the development of safe and non-invasive laboratory tests to estimate a person's susceptibility in the genital tract would be useful in clinical studies of new HIV prevention tools.

Heterosexual intercourse is the most common mode of transmission of HIV, but the risk of HIV acquisition after exposure is so low that studies to assess HIV risk must have a huge sample size. The goal of this study is to assess the suitability of a prototype pseudovirus assay to identify early HIV target cells in the female genital tract, using cervical cytobrush samples collected from healthy women, and to optimize assay sensitivity.

This novel HIV entry assay may overcome the need for a large sample size by directly measuring how susceptible a person is by using a sample similar to a PAP test. The assay is performed on immune cells obtained from a cervical cytobrush and enables assessment of HIV cell entry within 24 hours. If the assay works, this technique may have the potential to assess the impact of clinical parameters such as stage of menstrual cycle, or sexually transmitted infections and their treatment on HIV susceptibility in the female genital tract. Therefore, the assay may serve as an important monitoring tool in clinical trials of HIV prevention, serving as an invaluable intermediate endpoint to assess HIV acquisition risk, rather than relying on actual participant HIV seroconversion/infection.

Eligibility Criteria:
Inclusion Criteria:

* women over the age of 18 years

Exclusion Criteria:

1. pregnant
2. actively menstruating
3. known HIV infection
4. genital ulceration or discharge on history or physical examination
Telerehabilitation in Rheumatic Diseases

Telerehabilitation (TR) became more popular during COVID-19 pandemic due to social isolation and curfew. Exercise is one of treatments for patients with rheumatic diseases that are known to have low levels of physical activity.

Telerehabilitation (TR) aims to decrease barriers such as distance, time and cost by using technology to patients and clinicians. It provides to obtain rehabilitation for patients who cannot go to a medical center due to physical, environmental or economic inadequacies. COVID-19 is a contagious respiratory disease that is caused Severe Acute Respiratory Syndrome causing Coronavirus-2 (SARS-CoV-2). It was firstly seen in December 2019 in Wuhan, China and spread rapidly all over the world. World Health Organization (WHO) was declared COVID-19 as a pandemic in March 2020. The most common symptoms are fever, cough and dyspnoea. Social isolation and staying home have been suggested to reduce the spreading rate of COVID-19 pandemic in many countries. In addition, curfew except necessity was applied in some countries and time of curfew varied by country. Patients with rheumatic diseases are at higher risk of infections because of disease activity and immunosuppression. In addition, old age and having concomitant chronic disease are among risk factors for coronavirus. Therefore, national health services recommend patients to practice self-isolation and self-quarantine. However, social isolation was concluded with more increased physical inactivity and sedentary lifestyle. Physical inactivity and disuse are proven to cause joint destruction, decreased aerobic capacity and muscle atrophy in patients with rheumatic diseases.The importance and requirement for TR were observed better during the COVID-19 pandemic. Therefore, aim of this study was to investigate the effects of TR on fatigue, depression, anxiety, sleep quality, disease activity and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 to 65
* Have diagnosed with Romatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erthematosus or Fibromyalgia

Exclusion Criteria:

* Being pregnant
* Diagnosed with malignancy
* Had changes of medical treatment in the last 3 months
* Had dysfunction that limited physical activity such as severe neurological impairment, immobility or cooperation deficits
* Had regular exercise habit (minimally three days in a week)
* Had cardiac symphtoms according to New York Heart Association
Clinical Evaluation of Cordio Application in Adult COVID-19 Virus Positive Patients

Study on adult patients positive to COVID-19 virus. After signing informed consent and undergoing screening assessments, eligible patients will record few times a day several pre-defined sentences to the Cordio App installed in a smartphone/tablet.

The app will upload the vocal data to the sponsor's servers for analysis. The patient will record at hospital admittance (COVID-19 positive) until patient defined as COVID-19 negative and free of relevant clinical symptoms.


Eligibility Criteria:
Inclusion Criteria:

1. 18+ years old
2. Diagnosed with COVID-19 positive patients according to medical center guidelines, with symptoms of cough and or dyspnea. Patients that diagnosed with pneumonia, should be confirmed by X-ray and/or CT.
3. Able to understand and provide written informed consent (manually or electronically or giving their consent via the telephone to the study investigator in case of isolated patients).

Exclusion Criteria:

1. Subjects, in the Investigator's opinion, unable to comply with the daily use of the application including mental disorders (e.g., depression, dementia).
2. Patients with severe alcohol or drug use.
3. Women who are pregnant or lactating.
4. Participating in another investigation therapy that may interfere with study results (according to investigator discretion)
A Study of Famitinib in Combination With HS-10296 in Patients With EGFR-mutant NSCLC

The study is being conducted to evaluate the efficacy, safety and tolerability of famitinib combined with HS-10296 in subjects with advanced EGFR-mutant NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Subject's written informed consent obtained prior to any process, sampling, or analysis related to the study.
* Male or female, no less than 18 years old.
* Confirmed as NSCLC by histology or cytology.
* Locally advanced or metastatic NSCLC and not suitable for radical surgery or radiotherapy.
* Have not received EGFR Tyrosine Kinase Inhibitor (TKI) therapy.
* At least one baseline tumor lesion.
* Can swallow pills normally.
* Eastern Cooperative Oncology Group (ECOG) performance status 0\~1 points, expected survival≥12 weeks.
* Adequate organ function.

Exclusion Criteria:

* Clinically symptomatic central nervous system metastases.
* Ascites, pleural effusion or pericardial effusion with clinical symptoms.
* Other malignant tumors in the past 5 years or at the same time.
* High blood pressure which are not well controlled.
* Heart disease that are not well controlled.
* Coagulation dysfunction, bleeding tendency or receiving thrombolysis or anticoagulant therapy.
* History of bleeding.
* Known hereditary or acquired bleeding and thrombophilia.
* Any serious or uncontrolled ocular lesion.
* Interstitial lung disease or non-infectious pneumonia treated with corticosteroids.
* Congenital or acquired immunodeficiency.
* Other factors that may affect the results of the study or cause the study to be terminated midway.
Eyelid Movement Sensor Device- Blinking Characterizing

The investigators have developed a simple to use device that facilitates the monitoring of the upper eyelids motion, acquires the eyelid vertical movement and enables analysis and graphic presentation of the results. the device system consists 3 components : glasses for the patient including magneto sensitive probes, hardware and dedicated software.

Our purpose is to characterize eyelid motion in normal population. The methods include measuring each patient 10 minutes during watching a short movie.

Essentially, for Hall-probes monitor the magnetic field generated by a tiny magnets attached to the upper eyelid.

Eligibility Criteria:
Inclusion Criteria:

* healthy 18-67 year olds with no eye medical history

Exclusion Criteria:

* pregnancy
* head trauma history
* using contact lens
Combined Anticholinergic Medication and Sacral Neuromodulation to Treat Refractory Overactive Bladder

This study is a retrospective chart review including all patients who received surgical placement of a SNM device with Dr. Noblett from 2001 to the present.

The following data will be collected from patient charts: age at time of surgery, gravidity/parity, body mass index, pre-existing medical conditions/surgical history, current medications, menopausal status, form and severity of OAB symptoms, other previously or currently used interventions, method of SNM device placement, observed motor/sensory response, percent improvement of symptoms, follow-up OAB symptoms, frequency of InterStim settings adjustments, adverse events, significant changes in health, and incidence/reason for drop out.

Eligibility Criteria:
Inclusion Criteria:

* Female patients with symptoms of OAB, namely urge incontinence and urgency-frequency.
* Ages 18 and older.

Exclusion Criteria:

* Any patient who received surgical placement of an SNM device to treat non-obstructive urinary retention, or the symptoms of an underlying neurologic pathology, such as Parkinson's or Multiple Sclerosis.
The Effect of Esmolol on Clinical Prognosis of Patients With Severe Sepsis

The purpose of this study was to investigate the effect of esmolol on hemodynamic parameters,tissue perfusion and the clinical prognosis of patients with severe sepsis

enrollment:151 patients

Inclusion criteria: (1) age \> 18 years; (2) severe sepsis (acute organ dysfunction secondary to infection )diagnosis according to Campaign to Save Septic Patients: 2008 Treatment Guidelines for Severe Sepsis and Septic Shock, who (3) mechanical ventilation via endotracheal intubation with a tidal volume of 6 mL/kg; and (4) satisfactory sedation and analgesic treatment, with HR \> 100 bpm.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years;
* severe sepsis (acute organ dysfunction secondary to infection )diagnosis according to Campaign to Save Septic Patients: 2008 Treatment Guidelines for Severe Sepsis and Septic Shock,
* mechanical ventilation via endotracheal intubation with a tidal volume of 6 mL/kg;
* satisfactory sedation and analgesic treatment, with HR \> 100 bpm.

Exclusion Criteria:

* pre-existing cardiac dysfunction, valvular heart disease, high-degree atrioventricular block;
* acute or chronic pulmonary heart disease;
* a history of serious asthma;
* chronic renal insufficiency;
* cancer, autoimmune diseases, or contraindications for placement of deep venous catheter;
* insulin-dependent diabetes.
Nilotinib for Patients With Chronic Myeloid Leukemia in First Line and Any Subsequent Line

This was a non-interventional observational study within the routine chronic myeloid leukemia treatment practice; no further tests were required apart from the assessments routinely performed for Chronic myeloid leukemia patients treated with nilotinib.

The observation period per patient was 24 months. All patients were treated with nilotinib in accordance to the clinical routine at the respective institution and the summary of product characteristics (SmPC).

The observation intervals (documentation at baseline and at about 3, 6, 9, 12, 18 and 24 months) were not fixed and were aligned with the regular treatment schedule and the clinical symptoms of each patient. The medical decision about the schedule as well as therapeutic and diagnostic measures was made solely by the responsible physician. Patients who discontinued treatment within two years of the observation period were followed until starting a new TKI therapy line, however with a maximum time period of six months. All other patients that reached the official end of treatment after completion of the 24-month observation period were followed up for 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients diagnosed with Ph+ CML (or evidence of BCR-ABL transcript) treated with nilotinib under routine medical practice and the SmPC, as amended, in first or any subsequent line, if the current therapy with nilotinib has not been in place for more than twelve months. Retrospective documentation of patients for up to one year will be permitted.
* Patients who have already had an interruption/discontinuation of nilotinib therapy.
* Patients who have been informed about this NIS and have personally dated and signed their informed consent form.

Exclusion Criteria:

* There are no exclusion criteria, apart from the contraindications mentioned in the SmPC. Participating patients are not allowed to take part in a clinical trial in parallel,