cyrilzakka/clinical-trials huggingface dataset:
The Efficacy of Silymarin on the Prevention of Hepatotoxicity From Antituberculosis Drugs

Hepatitis is one of the most common adverse effect from anti-tuberculosis. Silymarin showed its efficacy to decreased serum alanine transaminase enzyme in animal models from recent study. No confirmed this efficacy was performed in human.

A prospective, double-blind, placebo-controlled trial was carried out according to Good Clinical Practice Guideline. This study is to define the efficacy of silymarin to prevent hepatotoxicity from anti-tuberculosis drugs. Informed consent is obtained prior to the study. New patients diagnosed with tuberculosis are enrolled. Patients with liver diseases, current alcohol drinking more than 20 g/day, regular use of herbal or other potential hepatotoxic drugs are excluded. Patients are treated with a standard regimen of four anti-tuberculosis therapy. They will randomize to receive either placebo or silymarin (140 mg) thrice daily. Liver function test (LFT) and clinical changes are assessed at 2- and 4-week after initiation of the treatment. DILI from anti-tuberculosis drugs ('atb-DILI') is defined as: i) a rise of alanine aminotransferase (ALT) to 2 times above normal upper limit, or ii) an elevation of total bilirubin more than 2 mg/dl with or without ALT elevation. The study endpoints are the level of ALT by week 4 and the number of patients who developed atb-DILI.

Statistical analysis is used to compare the differences in ALT and number of atb-DILI

- Prevention of antituberculosis-related drug induced liver injury with silymarin is investigated.

Eligibility Criteria:
Inclusion Criteria:

* tuberculosis cases
* treated with isoniazid, rifampicin, ethambutol and pyrazinamide

Exclusion Criteria:

* no known liver disease (HBV, HCV), and HIV infection
* normal ALT level before enrollment
* refuse to participate
Families in Balance: Enhancing Household Routines and Reducing Early Childhood Obesity Among Families With Low-income

This study will evaluate the effects of two different approaches to support healthy family mealtime, sleep, and screentime routines: A parent leader-guided online program that promotes parent and child self-regulation as a means to improve healthy family routines versus an asynchronous program that provides parents information about healthy family routines. Families will be randomly assigned to either of these programs and changes in parent and child outcomes will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Parents must be the legal and custodial guardian of a 2 through 5-year-old child
* Parents must report that their child is eligible for public health insurance
* Parents must be able to complete the study activities in English
* Parents must be able to complete study activities at a study location or at home, and online/via Zoom.

Exclusion Criteria:

- Children must not have serious medical problems that affect weight, sleep, activity, or eating.
The Effect of Ischaemic-Reperfusion and Ischaemic Preconditioning on the Endogenous Fibrinolysis in Man

Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the heart. Current treatments are designed at relieving this blockage as quickly as possible to minimise damage to the heart muscle. However in restoring the supply of blood local damage known as "ischaemia-reperfusion injury" may occur. The aim of this study is to assess how clot forming and clot dissolving pathways are affected during this process, and examine the role of a natural inflammatory hormone, bradykinin. This will help us to understand the mechanism by which ischaemia-reperfusion injury may occur and to devise new treatments for heart attacks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males between 18-65 years of ages, non-smokers.

Exclusion Criteria:

* Any concurrent illness or chronic medical condition. Concurrent use of vasoactive medication. Smoking history.
Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

To evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time.

This trial is a single institution non-randomized study to evaluate the efficacy and safety of the da Vinci® Robotic Surgical System. This study will evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time. This is a robotic system used by surgeons to perform surgery in a less invasive manner.

Eligibility Criteria:
Inclusion Criteria:

* Head and neck lesions requiring surgical resection, biopsy, or invasive treatment;
* Lesion amendable to robotic assisted surgery treatment;
* Age \> 19 years;
* Patient must sign informed consent.

Exclusion Criteria:

* Psychological condition that renders the patient unable to understand the informed consent;
* Poor mouth opening, with maximal opening less than 1.5 cm.
Outcomes of Digital Alerting Systems in Secondary Care

Why? The investigators are trying to find out if participants that suddenly deteriorate on the ward can be identified sooner by wearing a wearable sensor. This is an important study to see if the sensor works correctly in recording continuous vital observations of heart rate, respiratory rate and temperature. This information can help doctors and nurses identify un-well participants.

What? The investigators will ask the participants to wear a light wearable sensor on the chest that can be worn for 5 days. If the participants are still in hospital after this time the sensor can be changed. All sensors are disposable. The participants would not have to actively do anything to the sensor. We will also participants to complete a short questionnaire about the sensor.

Who? All participants on the ward that are admitted with a new medical or surgical problem can take part in the study. Participants undergoing a surgical procedure that require at least one overnight stay are eligible to take part in this study.

Where? This study is being conducted at West Middlesex University Hospital and St Marys Hospital Paddington. Only certain wards are being included at both sites, if the participant moves wards the sensor will be removed.

How? The study will last around 5 years and we aim to recruit 1000 participants.


Eligibility Criteria:
Inclusion Criteria:

* Admitted adults on a general medical or surgical ward, identified as suitable by the clinical team.
* Able to provide written consent

Exclusion Criteria:

* pacemaker/ICD
* open chest wound injury
* skin condition preventing sensor to be worn
* participant whom withdraws consent
Role of Enhancing Serotonin Receptors Activity for Sleep Apnea Treatment in Patients With SCI

The purpose of this study is to look at the effect of exciting using drugs to target a specific pathway in the body, that relies on a natural chemical the body produces called 'serotonin', in patients with spinal cord injury (SCI) during sleep. During this part of the study participants will be asked to take buspirone (Buspar) (15-50mg per day), trazodone (100mg per day) and a placebo in a random fashion, each for a 2 week period (drug period) of time followed by two weeks without drugs (washout period). The drugs will not be taken all at the same time, but each will be taken separately for two weeks followed by a night study to look at the effect the medication/placebo pill has on the way the body responds during sleep.

Randomized placebo controlled cross-over study. Each subject will be studied on three separate occasions: (1) Buspirone vs. Trazodone vs. placebo for 2 weeks; the patients will be blinded to whether they are taking trazodone or placebo; buspirone cannot be blinded because it is dosed twice a day and is up titrated during the two weeks of administration. The initial dose of Buspirone is 15 mg daily (7.5 mg bid.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day until a maximum dose 30mg/day is reached. After the two week treatment a sleep study will be repeated. Trazodone will be given at 100 mg dose before bed-time. (2) Cross over medication for two weeks will be followed by a second sleep study followed by two weeks washout. (3) Cross over medication for two weeks will be followed by another sleep study. To assess the clinical effect of the drug on breathing during sleep a qualitative polysomnography will be performed for 2 hours the same night after taking the drug/placebo. This will allow the determination of ventilatory changes and the determination of the number of respiratory events (apnea/hypopnea index).

Eligibility Criteria:
Inclusion Criteria:

* Adults with SCI (\>6months after spinal cord injury) at the T6 level/above

Exclusion Criteria:

* Pregnant and lactating females
* Heart failure, vascular disease, or stroke
* Advanced chronic obstructive pulmonary disease (COPD), liver disease, and chronic kidney disease
* BMI \>38 kg/m2
* Mechanical ventilation dependence
* The following medications are not allowed (potential interaction with buspirone or inhibition of the CYP3A4 system):

  * cimetidine
  * ketoconazole
  * ritonavir
  * itraconazole
  * erythromycin
  * diltiazem
  * verapamil
  * Monoamine oxidase (MAO) inhibitors \[such as Marplan, Nardil, Parmate, Emsam\]
  * Other prohibited concomitant medications include haloperidol, trazodone, or triazolam
Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity in Healthy Subjects

This is a randomized, placebo-controlled, double-blinded crossover design. Fifteen healthy subjects will be randomized to receive either ketone bodies (KE4) or placebo delivered by KetoneAid. After a period of 5-days treatment, effect variables will be measured (experiment day 1). After a washout period of 14 days, the subjects are crossed over to a similar treatment period with the other treatment. The study is terminated by measuring effect variables after the second treatment period (experiment day 2).

Background: Renewed interest in ketone bodies has emerged, partly driven by the recent success of selective sodium glucose co transporter 2 (SGLT-2) inhibition in preventing cardiovascular deaths in patients with diabetes mellitus (DM) and chronic kidney disease (CKD). Effects of ketosis are of importance in order to understand the beneficial effects of SGLT-2 inhibitors and to account for the full therapeutic potential of this treatment.

Hypothesis: Ketosis increases renal blood flow and glomerular filtration rate (GFR).

Methods: It is a randomized, placebo-controlled double-blinded cross over study. Fifteen healthy subjects will be randomized to receive either ketone bodies (KE4) or for 5 days. After a wash out period of at least 14 days, the subjects are crossed over to receive the other treatment. After each treatment period effect variables will be measured including Technetium(Tc)99m - Diethylenetriamine pentaacetate (DTPA) clearance and water based positron emission tomography computed tomography (PET/CT)

Perspectives: The study has the potential to provide information regarding the therapeutic potential of treatment with ketone bodies and understanding of conditions characterized by ketosis, such as SGLT2-inhibitor treatment.

Eligibility Criteria:
Inclusion Criteria:

* BMI \< 30 kg/m2
* Safe contraception if women in childbearing age
* Normal biochemical screening

Exclusion Criteria:

* Pregnancy or breast feeding
* Major heart-, liver-, kidney-, lung-, neurological- or endocrine disease
* Daily use of prescription drugs (expect for contraceptives)
* Alcohol or drug abuse
* Periodic fasting
* Routinely intake of ketogenic diet
A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With Durvalumab Versus Nivolumab Monotherapy in Participants With Select Advanced Malignancies

To evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination with Durvalumab versus Nivolumab Monotherapy in Participants with Select Advanced Malignancies.

This is a multicenter, open-label, Phase 1/2 study to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of MEDI0680 in combination with durvalumab or nivolumab monotherapy in adult immunotherapy-naïve participants with selected advanced malignancies.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years or older
* Eastern Cooperative Oncology Group performance status of 0-1
* Adequate organ function
* At least 1 prior line of therapy

Exclusion Criteria:

* Concurrent enrollment in another clinical study, unless in follow-up period or it is an observational study
* Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
* Prior treatment with immunotherapy
Bioequivalence of Ezetimibe Tablets in Healthy Subjects

According to the relevant provisions of bioequivalence test, ezetimibe Tablets (test preparation, T, 10mg / tablet) provided by China Resources Saike Pharmaceutical Co., Ltd. were compared with Ezetrol ® (reference preparation, R, 10mg / tablet) produced by MSD Pharma (Singapore) Pte. Ltd. to evaluate the bioequivalence of single dose in healthy subjects under fasting and fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects ≥18 years of age, with appropriate sex ratio;
* The body mass index is in the range of 19.0-26.0 kg/m2 (including the critical value). The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg.
* The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG, breath test for alcohol, drug abuse test and Nicotine test.
* The subjects have no family planning within 3 months and could select contraceptive method.
* Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.

Exclusion Criteria:

* Alanine aminotransferase \>1.0×ULN ,Aspartate aminotransferase \>1.0×ULN or Total bilirubin \>1.0×ULN.
* Subjects with allergic constitution.
* Being allergy to the study medications, smoking, alcohol abuse.
* Participation in another clinical trial within 3 months.
GlowCaps Adherence Randomized Control Trial

This randomized control trial will explore interventions to promote medication adherence using a novel electronic device that can track daily pill use. 500 subjects will be randomized into 4 arms of the experiment. In addition to a control arm, our three arms will be: reminders, financial incentives, and reminders and financial incentives.

The investigators aim to study simple "behavioral economics" interventions that rely on consumer engagement to overcome cognitive and motivational barriers to medication adherence. Our goals are threefold: (1) to analyze which interventions are most effective in promoting medication adherence; (2) to analyze which interventions are most effective in promoting long-term habits that persist even when the interventions are removed; and (3) to understand how various patient characteristics (e.g. age or risk preferences) predict adherence or treatment receptivity. The investigators plan to track daily adherence of patients to a prescribed chronic disease drug using a new technology that electronically monitors when a pill bottle has been opened. In our control condition, patients will be monitored but not be provided with any reminders, adherence information, or incentive to adhere to their medication. Our three additional treatments will be either: (1) provide the patient with a daily email, text message, or phone call reminder to take the pill; (2) pay patients for each day that they take their pill (3) provide the patient with a daily email, text message, or phone call reminder to take the pill and pay patients for each day that they take their pill.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with chronic disease
* age 18-84

Exclusion Criteria:

* all patients not meeting inclusion criteria
* people who report that they currently use a day-of-the-week pill bottle
* people for whom AT\&T does not have reliable wireless service for the Glowcap to communicate with the Way To Health platform
Vascular Changes Due to Different Treatments of Lymphedema Secondary to Postoperative Breast Cancer

The objective of this study is to evaluate the effect of elastic compression, functional compressive bandaging (ECF) and active exercises in the bloodstream of the upper member ipsilateral to the surgical procedure for the treatment of breast cancer.

With increasing survival of women treated for breast cancer, it becomes necessary to evaluate the effect of therapeutic resources in morbidity due to surgical treatment of breast cancer. The objective of this study is to evaluate the effect of elastic compression, functional compressive bandaging (ECF) and active exercises in the bloodstream of the upper member ipsilateral to the surgical procedure for the treatment of breast cancer. The study will be conducted according to design random cross over and wash out period of 7 days. They will be evaluated 30 volunteers aged between 45 and 70 years, submitted to treatment of breast cancer. The volunteers will be submitted to three different therapeutic procedures applied randomly by lot: active exercises, functional compressive bandaging with active exercises and elastic compression with active exercises. The profile of blood flow, including speed and direction, will be assessed by Doppler ultrasound before and after, at 0, 15, 30 minutes. Normality will be verified by the Shapiro-Wilk test, and the effect of behavior between pre- and post-intervention will be evaluated by ANOVA two-way followed by post-hoc test Friedman followed rank, p \<0.05 . The data obtained in the study are intended to enhance the forms of physical therapy intervention in the face of circulatory morbidities resulting from breast cancer treatments.

Eligibility Criteria:
Inclusion Criteria:

* women diagnosed with breast cancer undergoing surgical treatment combined with axillary dissection or sentinel node biopsy
* diagnosed with moderate to severe unilateral lymphedema

Exclusion Criteria:

* Women with muscle-tendon injury and / or joint damage in the -affected limb,
* skin disorders,
* diabetes,
* circulatory disease not controlled, -chemotherapy
* radiotherapy,
* diagnostic with metastasis in the upper limb
* women pregnancy.
A Study of Therapy Selected by Molecular/Metabolic Profiling in Patients With Previously Treated Metastatic Pancreatic Cancer

The purpose of the study is selecting second line therapy for patients with pancreatic cancer using molecular profiling will improve 1 year survival.

Following first-line therapy with a gemcitabine based regimen, a significant number of patients will maintain an adequate performance status and be able to tolerate a second-line therapy. A recent phase III trial randomized patients to either 5-flurouracil (5FU), folinic acid or to the addition of weekly oxaliplatin to the same regimen of 5FU/folinic acid. The interim results showed a statistically significant survival advantage for the oxaliplatin containing arm (26 versus 13 weeks, P= 0.014). However the outcome of patients who have progressed on a first-line gemcitabine regimen is still poor with median survival of about 2-6 months.

Almost all patients with advanced APC, treated with gemcitabine alone or a gemcitabine based combination therapy will exhibit resistance to therapy. In patients treated with gemcitabine alone, the time to progression (TTP) is about 3-4 months. Thus most patients will exhibit progression and /or toxicity and will require second line therapy at 4-6 months into first line therapy. The best one year survival reported in a phase II trial is only 24%. However there is no standard second line therapy for APC, a rapid progression of tumor is seen in this setting, and new strategies based on rational target identification are needed. In this study we propose to select therapy based on the molecular profiling of each patients tumor.

Eligibility Criteria:
Inclusion Criteria:

* metastatic adenocarcinoma of the pancreas
* male or non-pregnant female
* 18 years of age or greater
* one prior therapy for the treatment of metastatic disease
* must start continuation therapy within 9 months of starting first line treatment
* have adequate organ and bone marrow function
* must have a Karnofsky performance status greater than or equal to 70
* one or more metastatic tumors measurable by CT scan and accessible for biopsy

Exclusion Criteria:

* operable or locally advanced pancreatic cancer
* metastatic tumor that is not amendable to biopsy
* known brain mets unless previously treated and well controlled
* active, uncontrolled bacterial, viral or fungal infections
* known infection with HIV, hepatitis B or hepatitis C
* pregnant or breast-feeding patients
The Effect of Non-invasive Hemoglobin Measurement in Hip Surgeries

Bleeding is one of the most important causes of mortality and morbidity in patients.

Hb levels are the most prevalently utilized monitoring parameter in hemorrhagic patients in the hemodynamic sense. Hemoglobin determination is studied at laboratories along with blood gasses or complete blood analysis. Recently, non-invasive techniques where measurement is made from the fingertips have been offered for use. One of these techniques is non-invasive hemoglobin (SpHb) measurement. SpHb is used as a trend monitor. Based on the severity of bleeding, the compensatory mechanisms of patients may be disrupted. This situation may lead to lower levels of toleration of anemia during bleeding. The relationship between blood transfusion and mortality is under debate.


Eligibility Criteria:
Inclusion Criteria:

* 18-60 years old
* General anesthesia undergoing hip surgery
* American society of anesthesiology (ASA) scores I-II-III

Exclusion Criteria:

* Receiving inotropic support
* Uncontrolled diabetes
* Arrhythmia
* Hypothermia
* Hyperbilirubinemia
* Jaundice
* Dark skin pigmentation
* Without voluntary consent
* Hypovolemia,
* hypotension,
* sepsis,
* blood diseases
Variation in Body Composition on the Fate of Older Subjects During SSR Hospitalization

The aim of this study is to correlate weight variation as well as body composition with mortality and unscheduled readmission of geriatric population

Weight loss in obese adults confers health benefits, while weight loss in the elderly is associated with an increased risk of mortality.

There are a large number of studies associating weight loss and mortality but the relationships between changes in body composition (ratio between fat mass and lean mass) and mortality are often contradictory and poorly understood in elderly subject. The aim at this study is to request at this question.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥70 years old
* Hospitalized in SSR for less than 7 days
* No patient opposition

Exclusion Criteria:

* patient with a pacemaker
* lake of nutritional assessment on admission
* lake of assessment of autonomy at admission
* Patient under guardianship or curatorship
* Patient participating in another clinical research
* Patient for whom a short stay (\<21 days) is planned in SSR