cyrilzakka/clinical-trials huggingface dataset:
Prophylactic or Preemptive Entecavir in Patients With Gastric Cancer Who Are Inactive Hepatitis B Carriers

There has been no report on whether the patients with gastric cancer who are also inactive Hepatitis B carriers should receive prophylactic use or preemptive Use of an Anti-viral Drug Entecavir. This open, randomized controlled clinical trial aims to compare the impact of the prophylactic use or preemptive use of an anti-viral drug Entecavir on the outcomes of patients with gastric cancer who are also inactive hepatitis B carriers during chemotherapy and the subsequent follow-ups.

Patients with gastric cancer who are also inactive hepatitis B carriers are enrolled and randomized into two groups as following. Patients in experimental group are treated with entecavir prophylactically in the dose of 0.5mg p.o. every day from the initiation of chemotherapy till 6 months after the end of chemotherapy.Patients in active comparator group are only treated with entecavir in the dose of 0.5mg p.o. every day from the time that the DNA copies of hepatitis B virus are more than 100 IU/ml till 6 months after the end of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with age between 18 and 75
2. Patient with histology-proven gastric adenocarcinoma.
3. Patients with Eastern Cooperative Oncology Group performance status (ECOG) of 0-1
4. Patients planned for at least 4 cycles of cytotoxic chemotherapy (either as part of curative therapy or as palliative therapy)
5. Patients with at least 6 months' life expectancy from date of recruitment
6. Patients with positive Hepatitis B Surface-antigen (HBsAg)
7. Patients with normal liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase alkaline (AST), phosphatase (ALP), gamma glutamyl-transpeptidase (GGT), and bilirubin
8. Patients with negative HBV-DNA
9. Patients with no known history of radiological \&/or histological diagnosis of chronic active hepatitis or cirrhosis of any cause, or history of prior hepatitis B reactivation, or prior chronic therapy for HBV within 6 months
10. Patients with no evidence of autoimmune hepatitis, hepatitis C or D virus infection, HIV infection or radiological evidence of liver metastasis
11. adequate bone marrow, hepatic, and renal function within 14 days before recruitment
12. patients who sign the informed consent
13. Patients with good compliance during chemotherapy and follow-ups

Exclusion Criteria:

1. Patients planned for radiation or radionuclide therapy
2. Pregnant female patients
3. Patients with a history of psychiatric drugs abuse and can't quit or with a mental disorder
4. Patients with immunodeficiency, other congenital or acquired immunodeficiency, or transplantation history
5. According to the investigators' judgment, patients with concomitant disease that seriously harms patients' safety or the completion of study.
Acupuncture for Stroke Recovery

Based on the evidence, a pre-post test pilot study design will be implemented to clarify the benefits of an acupuncture intervention before and after treatment. The initial assessment will contain a brief demographic interview and a review of medical records, and both pre and post-intervention evaluations will comprise an imaging protocol that includes RS-fMRI, pCASL, diffusion kurtosis imaging (DKI), and a brief cognitive assessment, as described in greater detail below. Several quantitative measures within DMN regions will be generated and compared between pre- and post-acupuncture therapy. These include 1) RS-fMRI measures such as connectivity strength and fractional amplitude of low frequency fluctuations (fALFF); 2) regional CBF measured with pCASL; 3) water diffusion measures for microstructural changes with DKI.

A pilot sample of 5 individuals with left CVA's will participate in a 6 session acupuncture intervention. Pre and post fMRI and cognitive data will be compared.

The objectives of this study are 1) to determine the effects of acupuncture in improving cognitive performance in a pilot sample of 5 individuals who have experienced a left CVA and 2) to clarify the mechanism of improvement via functional brain imaging.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have experienced a left Cerebrovascular Accident (CVA) at least one year prior to study participation and the injury timeframe is 1-10 years post stroke
* Be able to participate in the cognitive testing that has been validated with English-speaking samples
* Be right hand dominant
* Have an educational level between 14-18 years
* Evidence history of cognitive decline post-stroke without significant impairment
* Have adequate vision, hearing, communication, and motor skills

Exclusion Criteria:

* Evidence cognitive impairment that would negatively impact capacity to understand and participate in this study
* Be participating in active therapeutic treatments that may independently improve cognitive function
* Have had a change in medication over two weeks before the start of study procedures or through the study protocol
* Have contraindications for acupuncture or MRI.

Contraindications to fMRI include:

* having a pacemaker, defibrillator or wires other than sternal wires.
* Metallic foreign body in the eye - these might move or heat during scanning resulting in serious eye injury.
* Deep brain stimulator
* Swan-Ganz catheter
* Bullets or gunshot pellets - near great vessels or vital organs, such as the lungs, heart or brain,
* Cerebral aneurysm clips - if magnetic, can move. Also not scanned if type unknown.
* Cochlear implant - malfunction.
* Magnetic dental implants - loss of magnetic hold to keep the implant in place.
* Certain Drug infusion devices
* Main contraindications for acupcunture in this study include: Pregnancy, IV anticoagulant therapy, uncontrolled coagulation blood disorders like haemophilia, malignant tumors, and fear of needles.
Laparoscopic Transvaginal Hybrid Anterior Resection: a Prospective Data Collection

Transvaginal hybrid procedures are of interest as an available NOTES-Procedure for the clinical routine. Few authors have demonstrated the feasibility and safety of such procedures (e.g. cholecystectomy) in selected patient collectives. In 2008 Lacy at al. published the experience with a transvaginal sigmoidectomy as a first in human report. The aim of this prospective data collection is to evaluate the feasibility and safety of the transvaginal hybrid anterior resection in the clinical routine.

Therefore all patients giving the informed consent to the transvaginal hybrid anterior resection will be included and assessed concerning feasibility to perform the transvaginal approach and complete the operation transvaginally.


Eligibility Criteria:
Inclusion Criteria:

* given informed consent
* sigmoid diverticulosis (two or more attacks)
* sigmoid diverticulitis (Hinchey I and II)

Exclusion Criteria:

* ASA IV
* emergency surgery
* liver-malfunction or coagulation disorders
* acute diverticulitis (Hinchey III and IV)
* malignancy
* acute vaginal infection
* refusal of mandatory preoperative gynecological examination
* pregnancy
* endometriosis
* previous surgery of colon and rectum
* strongly retroflexed uterus
* acute pelvic disorders, infection
Dose Response Study of a Topical Gel for the Treatment of Raynaud's Phenomenon

The Purpose of this study is to determine the response to two different strengths of a topical gel containing nitroglycerin in patients with Raynaud's disease.

The Purpose of this clinical study is to determine, in a controlled fashion, the response to two dosage strengths of a topical gel formulation of Nitroglycerin, MQX-503, in the determination of changes in finger blood flow and skin temperature in the fingers of patients with moderate to severe primary Raynaud's phenomenon and with Raynaud's phenomenon secondary to autoimmune diseases, such as scleroderma. The dosage strength response in the treatment of the symptoms (pain, tingling, numbness) will also be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients, 18 to 75 years
* Clinical Diagnosis of Raynaud's, or observed event by study physician, or symptoms with reduced blood flow as meausred using laser doppler equipment
* Agree to have test gels applied to finger
* Discontinue current vasodialator therapeis for Raynaud's treatment
* Four weeks from last clinical trial participation
* Agree not to use any other investigational medications or therapies to treat Raynaud's and its symptoms while participating in this study including other dosages or forms of nitroglycerin, isosorbide dinitrate, fenoldopam mesylate, milrinone lactate, nifedipine, diltiazem, felodipine, nimodipine, nisoldipine, and verapamil
* Negative pregnancy test for women prior to study start and agree to use effective contraception throughout
* Must be able to give written informed consent and comply with all study requirements

Exclusion Criteria:

* Concurrent use of any nitrate medication or medications known to interact with Nitroglycerin such as sildenafil, and other treatments for erectile dysfunction
* Patients who have a known allergy to Nitroglycerin or common topical gel ingredients
* Patients with a history of migraine, cluster or vascular headaches, or those who suffer from chronic pain
* Patients with a history of an unstable medical problem or any current condition that would interfere in participation in the study
* Patients unable to complete pain assessment instructions
* Patients who in the last three months have had a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension or uncontrolled hypertension
* Patients who have participated in another investigational drug study within four weeks of the first study treatment
* Patients with out of range laboratory screening values
* Patients who have had major abdominal, thoracic or vascular surgery within six months of the first study treatment
* Patients with open lesions or skin conditions where gel is to be applied
* Pregnant or nursing women
* Women who will not agree to comply with contraceptive requirements
* Patients with a history of poor compliance, poor cooperation or unreliability
Adipose Tissue Pre and Post Bariatric Surgery

Published data suggest that inflammation and fibrosis of adipose tissue could be factors favoring the development of insulin resistance in obese individuals and that a decrease in the activity of the AMP-activity kinase protein (AMPK) could lead to these dysfunctions. However, very few data are available in humans.

There is also growing interest in persistent organic pollutants (POPs) as a cardiometabolic and type 2 diabetes (T2D) risk factor. There is some evidence to suggest that POPs directly contribute to lipid metabolism dysfunction and insulin resistance. Additionally, POPs are stocked in adipose tissue. The accumulation of POPs in adipose tissue therefore limits their bioavailability to other organs, thus reducing their systemic toxicity. It has been observed that a large amplitude weight loss leads to a significant increase in POPs in the blood.

The goal of this project is to identify adipose tissue factors/dysfunctions that contribute to insulin resistance and type 2 diabetes associated with obesity in humans and thus raise avenues for screening and treatment of these metabolic complications. More specifically, the objectives are:

* To study the relationship between AMPK, fibrosis and inflammation of adipose tissue and their role in the development of insulin resistance and T2D associated with obesity;
* To examine the relationship between POPs and the cardiometabolic profile.


Eligibility Criteria:
Inclusion Criteria:

1. Awaiting bariatric surgery
2. BMI ≥ 35 kg/m2 without cardiometabolic complications or ≥ 30 kg/m2 if presence of type 2 diabetes or hypertension
3. ≥ 18 years old
4. Non smoker
5. Sedentary (less than 3 hours of regular physical activity per week)

Exclusion Criteria:

1. Type 1 diabetes
2. Acute event in the last 3 months (myocardial infarction, cerebrovascular hemorrhage or transient cerebral ischemia, unstable angina, peripheral vascular disease, revascularization or angioplasty, recent hospitalization for more than 4 days)
3. Infection in the last month (fever, antibiotics treatment)
4. Cancer in the last 3 years
5. Chronic inflammatory disease
6. Pharmacologic treatment (any medication affecting glucose metabolism (except those for diabetes), hypotensive medication unless stable dose for at least 1 month, lipid-lowering medication unless stable dose for at least 1 month)
7. Uncontrolled disease of pituitary or thyroid gland
8. Bleeding disorders
9. Alcohol or drug abuses
10. Claustrophobia
Incidence and Progression of Glaucoma in the Tema Eye Survey Cohort

Aim 1: To determine the incidence of glaucoma in Ghana in subjects previously found to be non-glaucomatous in the Tema Eye Survey.

Aim 2: To characterise the progression of glaucoma and the outcomes of subjects diagnosed with glaucoma in the Tema Eye Survey.


Eligibility Criteria:
Inclusion Criteria:

- glaucomatous and non-glaucomatous patients previously seen in the Tema Eye Survey who are selected and invited to participate

Exclusion Criteria:

- patients not previously seen in the Tema Eye Survey
Nutritional Assessment Tool and Nutritional Intervention in Childhood Chronic Liver Disease

Children (Exclusively breast fed: 6mo - 3yrs, and who are not exclusively breast fed 3mo to 3 yrs) with infantile cholestasis syndrome will be randomized to either recieve indigenously prepared oral nutritional supplement (energy dense supplement appox. 2 kcal/mL, prepared from locally available, affordable, socially acceptable food items - milk, sugar, edible coconut oil, egg and custard powder as base) in addition to standard nutritional counseling by a trained dietician (Group A). The control group (Group B) in comparison will receive standard nutritional counseling from a trained dietician but will not receive any additional nutritional supplement. All the children will be followed up at 1 month, 3 months, 6 months, 9 months and 1 year after inclusion. Clinical, nutritional assessment and laboratory data will be collected at each visit. Additionally IL-6 levels will be done at each visit in children of both arms of the intervention group.

The outcomes of interest will be growth and improvement of nutritional status parameters, hepatic morbidity (ascites, gastrointestinal bleeding, encephalopathy, {SBP (Spontaneous Bacterial Peritonitis), HRS (Hepatorenal Syndrome), etc and outcome (improvement, death or Liver Transplantation}.

All children will receive individualized standard treatment for infantile cholestasis syndrome including vitamin supplements/endotherapy/ beta blockers/ prophylaxis for SBP (Spontaneous Bacterial Peritonitis)/cholangitis (to at risk children) and drug therapy wherever indicated (steroids/ copper chelation/ UDCA).


Eligibility Criteria:
Inclusion Criteria:

1. Nutritional intervention in children with moderate and severe malnutrition as pr standard anthropometric measures children (Exclusively breast fed: 6mo - 3yrs, and who are not exclusively breast fed : 3mo to 3 yrs) with infantile cholestasis syndrome)
2. Hindi/English speaking family

Exclusion Criteria:

1. Any metabolic or endocrinal diseases independently affecting nutritional status
2. Refusal to give written informed consent to participate in the study
Integrated Care for Frail Older People

This is a qualitative interview study investigating patients', carers' and providers' perspectives on integrated care and integrated care pathways for frail older people in Lambeth and Southwark, south London.


Eligibility Criteria:
Inclusion Criteria:

1. Frail older people aged 65 years and over, including men and women with different levels of frailty.
2. Carers (family member, friend or neighbor) identified by the frail older participant as a main carer.
3. Health and social care professionals, care workers, service managers and commissioners working in different parts of the local health and care system (primary, secondary, community, social and voluntary care), reflecting a range of roles.

Exclusion Criteria:

1. Older people not identified as frail.
2. Frail older people who are unable to provide their informed consent to take part in the study, for example due to significant cognitive impairment.
Right For Me: Birth Control Decisions Made Easier

Right For Me is a study that aims to improve the conversations patients and health care providers have about birth control. Right For Me will test two different strategies for improving these conversations. The first strategy is to give patients a video to watch that encourages them to ask three specific questions in their health care visit, as well as a prompt card that reminds them of the three questions. The second strategy is to give health care providers a set of decision aids that describe available birth control methods, as well as training in how to use them with patients during the health care visit. Right For Me will test whether introducing one or both of these strategies leads to better conversations than providing health care as usual.


Eligibility Criteria:
Inclusion Criteria:

1. Completed a health care visit at a participating clinic
2. Assigned female sex at birth
3. Aged 15 to 49 years
4. Able to read and write English or Spanish
5. Not previously participated in the study

Exclusion Criteria:

1. Not completed a health care visit at a participating clinic (including a patient's parent or a person acting as a patient's legal proxy)
2. Not assigned female sex at birth
3. Aged under 15 or over 49 years
4. Unable to read and write English or Spanish
5. Previously participated in the study
Volanesorsen Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS)

The purpose of this program is to provide expanded access to volanesorsen for up to 100 Patients with Familial Chylomicronemia Syndrome (FCS).

The Program is intended to provide expanded access to volanesorsen for eligible patients with FCS who have limited or no available treatment options.

Eligibility Criteria:
Inclusion Criteria:

* Patients who participated in the APPROACH Open Label trial, must have completed the open label extension trial for volanesorsen for a length of time consistent with the study protocol (≥ 1 year). Patients in the APPROACH open Label trial for less than a year require approval from Akcea to participate in the EAP. Patients who did not participate in the APPROACH open label trial require approval from Akcea for entry into EAP.
* Patients not participating in the APPROACH open label trial must have a diagnosis of FCS as determined by the participating physician, as outlined in the Volanesorsen EAP protocol. Akcea will review each application to determine eligibility.
* Male patients and female patients of childbearing potential must continue to use appropriate contraception with their partners, or refrain from sexual activity

Exclusion Criteria:

* Patients who have any new conditions or worsening of existing conditions which in the opinion of the Physician would make the patient unsuitable for treatment with volanesorsen.
* Volanesorsen naïve patients with baseline platelet values ≤ 140,000/mm3
* Patients not willing to adhere to mandatory blood draws for platelet monitoring
* Patients who in the opinion of Akcea's medical team, are not eligible candidates for volanesorsen therapy.
* Any patient who plans to or becomes pregnant.
* Any patient who was withdrawn from the APPROACH open label study due to a serious adverse event related to volanesorsen therapy.
Sleep-Disordered Breathing in Heart Failure - The SchlaHF-Registry

Objective target of the registry is to investigate the prevalence of SDB as well as the clinical characteristics of patients with and without SDB as well as the predominant type of sdb.

For this purpose data from patients suffering from chronic, symptomatic heart failure with impaired left ventricular ejection fraction will be collected prospectively.

Despite recent advances in pharmacological treatment, congestive heart failure (CHF) continues to cause debilitating symptoms, frequent hospital admissions and a high mortality. Despite of therapy with beta-blockers and ACE-inhibitors many patients have persistent symptoms and most will eventually die of cardiovascular causes, often from progressive heart failure.

Sleep Disordered Breathing (SDB) is known to cause consequences, which have negative effects on heart failure.

Objective target of the registry is to investigate the prevalence of SDB, clinical characteristics, symptoms and the degree and type of SDB in patients with chronic HF.

For this purpose data from patients with chronic heart failure will be collected prospectively.In the registry several cardiologists in private practice or hospital and cooperating sleep laboratories shall participate.

Cardiologists screen patients with Chronic Heart Failure (chronic HF) prospectively. In case of suffering from chronic HF for at least 12 weeks since diagnosis, with NYHA III-IV or NYHA class II with at least one hospitalisation for HF in the last 12 months. Written informed consent for data privacy aspects must be obtained before screening for SDB. Patients who satisfy to all inclusion- and exclusion criteria will be included consecutively into the registry.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be over 18
* Chronic heart failure (at least 12 weeks since diagnosis) according to the current applicable guidelines
* Left ventricular systolic dysfunction (LVEF ≤ 45% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging) documented less than 12 weeks
* NYHA class III or IV at the time of inclusion or NYHA class II with at least one hospitalisation for HF in the last 24 months
* Patient is able to fully understand study information and signed informed consent

Exclusion Criteria:

* Life expectancy \< 1 year for diseases unrelated to chronic HF
* Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months
* CRT-implantation (either CRT-D or CRT-P) scheduled or within 6 months
* Transient ischemic attack (TIA) or Stroke within 3 months
* Hemodynamically significant uncorrected primary valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery
* Acute myocarditis/pericarditis within 6 months
* Current CPAP or bilevel therapy
ICG Indocyanine Green in Reconstructive Surgery

The success or failure of a reconstruction is largely related to the vascularization of the operated area. Near infrared fluorescence (also near infrared fluorescence angiography, NIR FA) with ICG administration is an innovative technique to quantify tissue perfusion. Based on the results obtained in other subspecialties, NIR fluorescence appears to be a promising way to quantify tissue perfusion in reconstructive surgery. Fluorescence research has previously been used in the context of microsurgery and breast reconstructions using implants, but structural objective determinations are lacking. Our study is successful if we are able to determine a cut off value for the absolute or relative perfusion parameters.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or older
* Undergoing debridement and/or reconstructive surgery included in the aforementioned groups

Exclusion Criteria:

* allergy or hypersensitivity to sodium iodide, iodine, ICG or shellfish
* patients with hyperthyroidism and patients with autonomic thyroid adenoma
* pregnancy or lactation
* epilepsy
* severe liver failure
* renal failure with a GFR \<60.