cyrilzakka/clinical-trials huggingface dataset:
Effect of Short-term Chinese Tea-flavor Liquor Consumption

Human studies of Chinese liquor are sparse. The investigators hypothesize that short-term Chinese Tea-flavor liquor (TFL) consumption may be beneficial to inflammation biomarkers and CVD risk factors. Guizhou Meijiao Liquor (GML) is a traditional Chinese liquor, fermented from sorghum, corn, sticky rice, wheat and rice, while TFL is a novel Chinese liquor fermented from above 5 grains plus green tea.

Forty-five volunteers(23 males, 22 females) were selected to participate a paralleled randomized trial drinking 30 mL two kinds of Chinese liquors: TFL and GML respectively with meal every day for 28 days. Serums of volunteers were collected for analyzing serum lipids, inflammation biomarkers and CVD risk factors.

TFL could significantly decrease systolic blood pressure of males, but increase diastolic blood pressure of females. TFL could also decreased blood lipid of volunteers, especially for females. Both liquor significantly decrease serum uric acid and glucose in males and females. The effect of the two liquors on inflammation biomarkers were complicated and needs further research work.

TFL may possess more beneficial effect on CVD risk factors than GML probably because of the special fermentation products of green tea with other grains.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers

Exclusion Criteria:

* Subjects with a history of liver disease, diabetes, or heart disease
* Smokers
Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis

Six hundreds patients with chronic hepatitis B clinically diagnosed as compensated liver cirrhosis are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir alone for the first 0.5 year, entecavir plus thymosin-α for 1 year, entecavir for another additional 0.5 year.Patients will be assessed at baseline, at every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan;


Eligibility Criteria:
Inclusion Criteria:

1. Patients from age 18 to 65 years ;
2. Male or female;
3. Treatment-naive patients of clinically diagnosed as HBV-induced compensated cirrhosis(meet one of the following two criterions);

   1. endoscopy: esophageal varices , exclusion of noncirrhotic portal hypertension
   2. if no endoscopy,should meet two of the four Criterias:

      * Imaging (US, CT or MRI, et al) showing Surface nodularity: Echogenecity
      * Platelet (PLT) \< 100×10 \< 9 \>/L , no other interpretation
      * Albumin (ALB) \< 35.0 g/L, or International Standard Value (INR) \> 1.3 (Prothrombin Time (PT) prolonged \> 3s), or Cholinesterase (CHE) decrease
      * Liver stiffness measurement value \> 12.4 kpa (ALT\<5×ULN)
4. HBeAg-positive, HBVDNA \> 2×10\<3\> IU/ml or with HBeAg-negative patients, HBVDNA \> 2×10\<2\> IU/ml;
5. Agree to be followed up regularly;
6. Signature of written inform consent.

Exclusion Criteria:

1. Patients with decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma;
2. Patients who are allergic to entecavir, thymosin or their components, and those considered not suitable for medicine in this study;
3. Patients with HCV or HIV infection, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, severe non-alcoholic fatty liver disease or other chronic liver diseases;
4. Patients with baseline AFP level higher than 100ng/ml and possible malignant lesion on image, or AFP level higher than 100ng/ml for more than three months;
5. Creatinine \> 1.5×ULN;
6. Patients with other uncured malignant tumors;
7. Patients with severe diseases of heart, lung, kidney, brain, blood system or other organs;
8. Patients with any other reasons not suitable for the study.
The Role of Diet and Lifestyle in Breast Cancer Survival

Diet has been found to influence hormone production and metabolism which in turn could affect the incidence of hormone related cancers. Consumption of soy-containing foods, known to be rich in phytoestrogens, is thought to be one of the chemoprotective factors against breast cancer in Asian populations. Phytoestrogens have a wide range of metabolic effects and may have a role in effecting breast cancer risk. Although there is mounting evidence of the positive influence of phytoestrogens on breast cancer risk, very little research has been carried out in humans as to the effects of phytoestrogens on breast cancer recurrence and survival. The DietCompLyf study aims to explore this effect by carrying out an observational study in 3,000 breast cancer women in the UK. The effects of diet, lifestyle practices and use of complementary treatments will also be investigated. Participants are recruited 9-15 months post-diagnosis and followed up for 5 years. Questionnaires as well as blood and urine samples are collected annually.

Women matching the eligibility criteria are consented at breast cancer follow-up hospital visits. Blood and urine samples are then collected and questionnaires are provided for the participants to take away and return within 4 weeks. The process of sample collection and questionnaire provision is repeated for visit at years 3 and 5.

Year 2 and 4 study visit vary in that questionnaires including a 7 day food diary are sent to participants at home to be filled in 7 days before their scheduled follow-up appointment. At hospital, blood and urine samples are collected as usual.

Eligibility Criteria:
Inclusion Criteria:

* Women with histologically confirmed invasive primary breast cancer grades I to III.
* age up to and including 75 years old

Exclusion Criteria:

* Previous cancer with the exception of basal cell carcinoma
* Concomitant primary cancer
* Bilateral cancer of the breast
* Psychological problems
* Cognitive impairment
* Poor understanding of English
A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS

This study is being done to evaluate the safety, tolerability and antitumor activity of oral CG-806 (luxeptinib) for the treatment of patients with Acute Myeloid Leukemia (except APML), secondary AML, therapy-related AML, or higher-risk MDS, whose disease has relapsed, is refractory or who are ineligible for or intolerant of intensive chemotherapy or transplantation.

This is a multicenter, open-label, Phase 1 a/b dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the MTD or recommended dose in patients with relapsed or refractory Acute Myeloid Leukemia (except APML), secondary AML, therapy-related AML, or higher-risk MDS whose disease has relapsed, is refractory or who are ineligible for or intolerant of intensive chemotherapy or transplantation. This is to be followed by a cohort expansion phase.

Eligibility Criteria:
Key Inclusion Criteria:

* Age ≥18 years
* Life expectancy of at least 3 months
* ECOG Performance Status ≤ 2
* Patients must be able to swallow capsules
* Adequate hematologic parameters, unless cytopenias are disease caused
* Adequate renal, liver and cardiac functions

Key Exclusion Criteria:

* Patients with GVHD requiring systemic immunosuppressive therapy
* Uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and clinically significant disease related metabolic disorder
* Clinically significant leukostasis
* Treatment with other investigational drugs or receipt of cytotoxic therapy within 14 days prior to first study treatment administration
* Receipt of cellular immunotherapeutic agents within 4 weeks prior to first study treatment administration
Insomnia in Patients Undergoing Chemotherapy and Radiation Therapy for Head and Neck Cancer

RATIONALE: Learning about insomnia and quality of life in patients undergoing chemotherapy and radiation therapy for cancer may help doctors learn about the effects of treatment and plan the best treatment.

PURPOSE: This clinical trial is studying insomnia in patients undergoing chemotherapy and radiation therapy for head and neck cancer.

OBJECTIVES:

* To assess the prevalence of insomnia, extent of sleep disturbance, and possible contributing factors to sleep disturbance in head and neck cancer patients undergoing chemoradiotherapy.
* To evaluate the relationships between insomnia and symptom burden, quality of life, mood, fatigue, and tumor/treatment variables in these patients.

OUTLINE: Patients complete a demographic survey and a questionnaire packet comprising The Pittsburgh Sleep Quality Index, The Head and Neck Symptom Survey, Profile of Mood States, Suspected Causes of Insomnia Survey, and a Quality of Life Survey on day 1 of chemoradiotherapy to obtain baseline data on sleep quality, possible causes of sleep disruption, head and neck symptoms, mood state, fatigue, quality of life, and patient demographics. Questionnaires are administered weekly thereafter during therapy visits for up to 6-7 weeks and take 15-30 minutes to complete.

Medical records are reviewed to obtain information regarding medications and tumor- and treatment-related variables.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of head or neck carcinoma
* Currently undergoing chemoradiotherapy

PATIENT CHARACTERISTICS:

* Able to communicate in English
* Able to give informed consent

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Role of Inflammatory Mediators in AERD

The purpose of this research study is to learn new information about the underlying cause of aspirin-exacerbated respiratory disease (AERD) and the benefit of high-dose aspirin therapy. AERD is a disease that involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other nonsteroidal anti-inflammatory drugs. This study will be conducted on individuals with AERD who are referred to the Brigham and Women's Hospital AERD Center for clinical evaluation and potential aspirin desensitization. Desensitization to aspirin and subsequent treatment with daily high-dose oral aspirin is standard of care for patients with AERD who do not respond adequately to steroids and have recurrent nasal polyposis or symptomatic asthma. This study will involve five visits to Brigham and Women's Hospital and will align closely with the standard of care for the treatment of AERD.


Eligibility Criteria:
Inclusion Criteria:

* History of asthma
* History of nasal polyposis
* History of at least one clinical reaction to oral aspirin or other nonselective COX inhibitor with features of both lower (cough, chest tightness, wheezing, dyspnea) and upper (rhinorrhea, sneezing, nasal obstruction, conjunctival itching and discharge) airway involvement
* Stable asthma (post-bronchodilator FEV1 of ≥70%, no use of oral or systemic steroids for at least 1 month, and no hospitalizations or emergency room visits for asthma for the prior 6 months) at the time of entry into the study
* Currently taking montelukast as part of standard asthma treatment for at least 4 weeks before the V1 visit

Exclusion criteria:

* Pregnancy or current breastfeeding
* History of bleeding diathesis or use of anticoagulant or antiplatelet drugs
* History of thrombocytopenia \< 50 x 10\^9/L
* Hypersensitivity to montelukast
* Peptic ulcer disease
* Unstable asthma (post-bronchodilator FEV1 of less than 70%, use of oral or systemic steroids for at least 1 month prior to visit 1, or hospitalizations or emergency room visits for asthma for the prior 6 months)
* Use of zileuton (which can mask symptoms of aspirin-induced reaction) within 1 month prior to the V1 visit
* Age under 18 or over 75 years
* Current smoking
First in Human Study of TORL-1-23 in Participants with Advanced Cancer

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer


Eligibility Criteria:
Inclusion Criteria:

* Advanced solid tumor
* Measurable disease, per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate organ function

Exclusion Criteria:

* Has not recovered \[recovery is defined as NCI CTCAE, version 5.0, grade ≤1\] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements
* Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-1-23
* Progressive or symptomatic brain metastases
* Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
* History of significant cardiac disease
* History of myelodysplastic syndrome (MDS) or AML
* History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded
* If female, is pregnant or breastfeeding
Effect of High Intensity Exercises in Treatment of Patients With Shoulder Impingement Syndrome

Purposes of the study

To investigate the effect of adding High-Intensity Exercises to conventional physical therapy in patients with Shoulder Impingement Syndrome

Patients will be randomized into either High-intensity shoulder exercise group or Conventional physical therapy group. Patients will receive the intervention for six weeks. Outcomes will be assessed at baseline and post-intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Athletic patients
2. Age of the patients between 18 - 35 years
3. Unilateral shoulder pain more than 3 months.
4. Positive Hawkins test.
5. Positive empty or full cane test.
6. Pain at night or incapable of lying on the shoulder.
7. Pain with active shoulder elevation in the scapular plane.
8. History of pain in the C5-C6 dermatome.
9. Pain with palpation of the rotator cuff tendons.
10. The patient had pain with resisted isometric abduction

Exclusion Criteria:

1. History of shoulder instability (positive Sulcus sign, positive apprehension test, and history of shoulder dislocation).
2. Clinical sign of cervical radiculopathy.
3. History of acromio -clavicular pain.
4. Rheumatoid Arthritis.
5. Adhesive capsulitis.
6. Tumors
7. Labrum lesions
8. Capsular or ligamentous tears or avulsions
9. Cartilage lesions
Tolerability And Efficacy Of High Dose Escitalopram In The Treatment Of Patients Suffering From Schizophrenia And Obsessive-Compulsive Disorder (OCD) - An Open Label Study

The purpose of the study is to evaluate tolerability and efficacy of escitalopram (Cipralex) treatment in doses beyond 20mg (20-40 mg/d) in patients with OCD and schizophrenia, non responsive or partially responsive to recommended doses (evaluation according to Y-BOCS).

An open label, prospective study. The study will include 20 patients recruited from the inpatient wards and from the outpatient clinic who have a DSM-IV diagnosis of schizophrenia or schizoaffective disorder and OCD.

Before entering the study all patients will be interviewed by 2 senior board certified psychiatrists in order to confirm the diagnosis of schizophrenia or schizoaffective disorder and OCD according to DSM-IV criteria.

After confirming the diagnosis of schizophrenia/schizoaffective disorder and OCD each patient will be evaluated by PANSS, Y-BOCS and GCI-S scales. Those patients who score above 12 points on the Y-BOCS will be eligible for the study.

Rating scales (PANSS, Y-BOCS, CGI-S, CGI-I) will be completed on a weekly basis during the whole 13 weeks period. In addition patients will be asked to report medication side effects and will also be clinically evaluated for side effects by the physician. Special attention will be paid to worsening of psychosis or OC symptoms. All patients whose mental status will deteriorate or those who cannot tolerate the drug will be dropped-out and intent to treat analysis will be made.


Eligibility Criteria:
Inclusion Criteria:

* All patients will be men and women over 18 years of age who meet DSM-IV criteria for schizophrenia/ schizoaffective disorder and OCD.
* Previous to entering the study all patients should be stabilized on antipsychotic medication for at least 3 months.
* Patients should score above 12 points on Yale Brown Obsessive Compulsive Scale (Y-BOCS) (Cut off point of Y-BOCS total score \> or =7 is the common practice in similar studies) (Kayahan et al 2005).

Exclusion Criteria:

* All patients who are under antidepressant treatment (including SSRIs and clomipramine).
* In patients who were on clomipramine or SSRI in the past are included, at least 2 weeks must have been elapsed since stopping the medication.
* In case the patient has received an antidepressant which is not an SSRI or clomipramine, there will be a washout period of one week before entering the study.
* If the patient received a MAO-inhibitors there will be a washout period of at least 2 weeks except for fluoxetine for which a washout period of 5 weeks is required due to its long half-life.
* Known contraindication for the use of citalopram or escitalopram.
* Abnormal ECG findings at baseline
* Unable to understand and give informed consent.
Diagnostics and Pharmacotherapy for Severe Forms of TB (DMID 15-0100)

Major Research Aim: To study novel molecular diagnostics and the pharmacokinetic variability among a spectrum of TB disease states, including severe forms of TB like disseminated TB, TB meningitis and drug resistant TB, among adults and children from multiple international sites.

Aim 1. Measure pharmacokinetics to anti-tuberculosis (TB) medications in severe TB syndromes (including multidrug-resistant TB, pediatric TB, TB sepsis and TB meningitis) from diverse geographies (including Tanzania, Uganda, Bangladesh, and Siberia) and correlate these findings to TB treatment outcome (TB treatment failure: death/ default/ relapse/ further acquired drug resistance).

Aim 2. Decipher mechanisms of pharmacokinetic variability to TB drugs, particularly malabsorption due to concurrent gastrointestinal disease.

Aim 3. Deployment of quantitative susceptibility testing (minimum inhibitory concentration-MIC) and rapid MIC-informed molecular methods (e.g., TaqMan Array Card-TAC) for M. tuberculosis.

In addition to the stated aims, the primary elements of capacity building requisite for this project include the training in and deployment of the fieldable molecular diagnostic platforms, onsite pharmacokinetic monitoring, and a broad strengthening of longitudinal cohort management for clinical research.

Eligibility Criteria:
Inclusion Criteria:

Patients admitted to one of the study site hospitals with at least ONE of the following:

1. Clinical suspicion for TB in a child, as defined by NIH Consensus Case Definitions for TB research in children, and started on TB treatment
2. Clinical suspicion for TB meningitis, as defined by the International TB Meningitis Workshop Consensus Case Definitions for TB Meningitis
3. Clinical suspicion for TB sepsis, as defined by the Uganda/PRISM-U definitions
4. Microbiologic evidence of MDR-TB from a respiratory specimen within the past 6 months

Exclusion Criteria:

1. Pregnant women-self reported
2. Patient unable per treating physician discretion to undergo sample collection
3. Patient or representative/guardian unable to sign written informed consent
4. Patient unable to return for follow-up or be contacted by phone for follow-up
Immune Function Status and the Prevalence of Hepatitis in Postpartum Pregnant Women With CHB Infection

To date, several studies have manifested that high levels of adrenal corticosteroids and oestrogen hormones during pregnancy can lead to increased HBV viraemia. These hormonal and immune function status changes can result in minimal fluctuations in liver function tests. Serum alanine aminotransferase (ALT) tends to increase in late pregnancy and the postpartum period. Peripartum hepatitis flares leading to hepatic decompensation have been reported.Therefore, the investigators aim to detect and observe the immune function status and incidence of hepatitis in pregnant women with chronic hepatitis B virus infection in late pregnancy and the postpartum period.To provide a clinical evidence for the administration of chronic hepatitis B virus infection pregnant women.

In this trial, pregnants who were positivity for serum HBsAg for more than 6 months and HBeAg , HBV DNA \>106IU/mL, alanine aminotransferase (ALT) below 35 IU/mL (ULN=40IU/mL) and no received nucleoside analogue antiviral therapy were enrolled into group A, In addition ,the CHB infection pregnants with undetectable HBVDNA were enrolled into group B(control group).In which, all pregnants were chronic HBV infection without compensated cirrhosis,hepatic adipose infiltration,ICP, hypertension ,heart disease, postpartum hemorrhage. None of the mothers were co-infected with hepatitis A,C,D,E,or HIV;syphilis, Epstein-Barr virus.Serum HBV DNA load(Roche, Pleasanton, CA, USA), HBsAg/anti-HBs level, HBeAg/anti-HBe routine blood test, liver function, renal function will be tested piror to delivery and postpartum 2,6,12 weeks. plasmacytoid dendritic cells(pDCs) and natural killer(NK)cells,CD4＋T cells and regulatory T (Treg) cells were detected by flow cytometry. Plasma cytokines Interferon-alpha 2(IFN-α2) / Interferon-gamma (IFN-γ) / Transforming growth factor beta1 (TGF-β1) / Interleukin-2 (IL-2) / Interleukin-6 (IL-6)/Interleukin-10(IL-10) / Interleukin-17A (IL-17A) / tumor necrosis factor-α1(TNF-α1)were measured by Luminex at the above time point except 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* pregnants who were positivity for serum HBsAg for more than 6 months and HBeAg , HBV DNA \>106IU/mL/undetectable HBVDNA ,alanine aminotransferase (ALT) below 35 IU/mL (ULN=40IU/mL) and no received nucleoside analogue antiviral therapy

Exclusion Criteria:

* compensated cirrhosis,hepatic adipose infiltration,ICP. hypertension ,heart disease. postpartum hemorrhage. pregnants who were co-infected with hepatitis A,C,D,E,or HIV;syphilis,Epstein-Barr virus.