cyrilzakka/clinical-trials huggingface dataset:
A Trial of Thymalfasin in Adult Patients With Hepatocellular Carcinoma

The objective of this Phase II trial is to compare the efficacy and safety of 6 months of treatment with thymalfasin plus trans arterial chemoembolization (TACE) with TACE alone in adult patients with non-surgical hepatocellular carcinoma (HCC).


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent.
* Diagnosis of HCC by:

  1. Presence of HCC on biopsy (core biopsy), or, if biopsy is strongly contra-indicated due to safety or patient-related concerns, then the diagnosis of HCC can be determined by:
  2. A new hepatic defect on imaging with an AFP \> 1000 ng/ml, or
  3. A new hepatic defect on ultrasound or CT with an AFP \< 1000 ng/ml when one of the following is present:

     1. At least two additional imaging techniques show signs characteristic of HCC, or
     2. The new hepatic defect has doubled in diameter over time, or
     3. The AFP has progressively risen to \> 200 ng/ml and triples the mean baseline.
* HCC must be unresectable and non-transplantable.
* Hematocrit \> 30%, platelet count \>= 50,000 per microliter, WBC \> 2.0 x 109/L, and polymorphonuclear white cell count \>= 1.0 x 109/L.
* Adequate renal function as demonstrated by serum creatinine level \< 1.5 mg/dl.
* If the patient is a woman, she is using a definitive method of birth control in consultation with her physician, or is surgically sterile or post-menopausal.

Exclusion Criteria:

* Concomitant chronic use of any drug known to be hepatotoxic, or of any immunosuppressive drug (Use of oral contraceptives will not exclude an otherwise eligible patient).
* Presence of main portal vein thrombosis or hepatic artery malformation.
* HCC amenable to treatment by surgical resection or hepatic transplantation.
* HIV infection diagnosed by HIV seropositivity and confirmed by Western blot.
* Concomitant or prior history of malignancy other than HCC within the last 10 years, except for curatively treated skin cancer or surgically cured in situ carcinoma of the cervix.
* Active infectious process that is not of a self-limiting nature. TB and AIDS are examples of infectious processes that are not of a self-limiting nature.
* Pregnancy as documented by a urine pregnancy test. Women with reproductive potential must agree to practice an adequate method of birth control for the duration of the study.
* Alcohol or intravenous drug abuse within the previous 1 year.
* Previous treatment with thymalfasin.
* Patients with known hypersensitivity to iodine.
* Simultaneous participation in another investigational drug study, or participation in any clinical trial involving investigational drugs within 30 days of study entry.
DPP-4 Inhibitors and Acute Myocardial Infarction:Effects on Platelet Function

Cardiovascular events are the main cause of mortality in diabetic patients ,on the other hand,during an acute myocardial infarction(AMI),hyperglycemia increases mortality and is related to different pathophysiologic processes.

More important evidence regarding the effect of glycemic control on AMI patients prognosis is contradictory,and the potential benefits of dipeptidyl peptidase-4 inhibitors(DPP4-i) in this setting is unknown.

The aim of this study is to assess the presence of pleiotropic effects of DPP4-i(sitagliptin or saxagliptin) and their relationship with glycemic control during in-hospital phase of AMI.

Randomized clinical trial,double-blinded,placebo-controlled, in a single center, to assess the influence of DPP4-i on platelet aggregability in type 2 diabetic patients with acute myocardial infarction in use of dual anti platelet therapy (DAPT) .

Others exploratory analysis include:glycemic control ,infarct size,genetic analysis and cholesterol metabolism.

After giving signed informed consent,eligible subjects will be randomly allocated to receive saxagliptin or placebo, in the first 48 hours (+-24) after the beginning of an AMI.

The investigator and subjects will be blinded to trial treatment,and a person not involved in trial conduct will prepare the doses of study drug.The doses will be administered by mouth,in a once daily basis by the investigator.

Blood samples will be collected by the investigator according to pre-specified outcomes and time frames.

Evaluation of glycemic control by CGM will be carried out by the investigator,including insert and withdrawal of the device.

Treatment of the acute event,(AMI) will be done according to routine procedures from coronary care unit.

Serious adverse event report taking into consideration all-cause mortality, cardiovascular mortality, hospitalization for heart failure and pancreatitis, will be done according to presence of these events.

Eligibility Criteria:
Inclusion Criteria:

* previous diagnosis of type 2 diabetes mellitus,with treatment including insulin and/or oral antidiabetic agent;
* subjects without previous diagnosis of diabetes,but HbA1c admission \>= 6,5% during current hospital-stay
* AMI with or without ST-elevation;
* use of double antiplatelet therapy;
* signed informed consent term

Exclusion Criteria:

* GFR \<30 ml/min;
* use of DPP4 inhibitors or glucagon- like peptide-1(GLP1) analogue in the past 6 months;
* use of strong inhibitors of cytochrome P450(CYP3A4/5) ou glucocorticoids;
* severe systemic decompensation requiring insulin infusion;
* Killip classification of myocardial infarction grade \>2;
* previous history of pancreatitis
A First-In-Human Study With a Single Dose UCB4019 in Healthy Volunteers

This study is designed to evaluate the safety and tolerability of single ascending doses of UCB4019 administered by subcutaneous injection in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Good physical and mental health
* At least 18 and less than 65 years of age
* Female subjects of childbearing potential must agree to use a highly effective method of birth control, during the study and for a period of 3 months after their last dose of study drug

Exclusion Criteria:

* Total Immunoglobulin G \<7 g/L or \>16 g/L at the Screening Visit
* Absolute neutrophil count \<1.5x10\^9/L and/or lymphocyte count \<1.0x10\^9/L
* Known viral hepatitis, has a positive test for Hepatitis B surface antigen or is Hepatitis C virus antibody positive
* Positive test to Human Immunodeficiency Virus (HIV) 1/2 antibodies
* Past medical history or family history of primary immunodeficiency
* Evidence of latent/active Tuberculosis (TB)
* Active infection or a serious infection within 6 weeks before the first dose of IMP
* Renal impairment
* Hepatic impairment
* Vaccination within 6 weeks before the Screening Visit or intent to have a vaccination before Day 43 of the Safety Follow-up Period
* Subject is splenectomized
* received any IMP or experimental procedure within 90 days before the first dose of IMP
* received UCB7665 in a clinical study
Evaluation of Levemir® for the Treatment of Type 1 and 2 Diabetes

This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using Levemir® under normal clinical practice conditions.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Type 2 diabetes
* Candidates of use of a basal insulin as part of their diabetes regimen

Exclusion Criteria:

* Unwilling to adhere to therapy or follow up
* Pregnancy
A Study Comparing DMSB01 and Rejuran® for Temporary Crow's Feet Lines Improvement

The objective of this Pilot Study is to verify the safety and efficacy of DMSB01 in the temporary improvement of Crow's Feet Lines


Eligibility Criteria:
Inclusion Criteria:

1. Among those who desire improvement in both sides of the crow's feet and have a Crow's Feet Grading Scale (CFGS) score of 2 or higher for both relaxed and maximum smile conditions
2. Individuals who have consented to abstain from any other dermatological procedures or treatments, including treatments for wrinkle reduction in the facial area, during the duration of this study

Exclusion Criteria:

1. Individuals with abnormal findings in visual-related tests (visual acuity test, Confrontational visual fields test, ocular motility test), specifically those with low vision (best-corrected visual acuity of 0.3 or less in the better eye).
2. Individuals who need to take anticoagulants from 2 weeks before the application of the investigational medical device to 2 weeks after the final application (with the exception of low dosage aspirin 100mg (up to a maximum of 300mg/day))
3. Individuals who need to take Vitamin E preparations, NSAIDs, or collagen preparations from 1 week before the application of the investigational medical device to 1 week after the final application.
4. History of bleeding disorder in past or present
A Trial for a Personalized Medication Management Platform to Improve Medication Adherence

Taiwan has attracted much attention for its National Health Insurance (NHI) and healthcare system around the world with many countries in Europe and the United States using it as a benchmark. However, increasing medication costs over the past two years account for more than 25% of total expenditure, surpassing every OECD member and mounting increasing pressure on the NHI. Nevertheless, patient medication adherence is relatively low. Thus, the investigators assessed the effectiveness of a personalized medication management system for improving the medication adherence for patients, in order to save long term medication costs.

Design, Setting and Patients: The investigators developed a mobile personalized medication management platform (PMMP) to reduce delayed and missed medications. The investigators conducted a randomized control trial in medical centers of northern Taiwan from January 2010 to July 2012 using 1198 participants that missed or delayed their medications during past three days. They received a minimum 7-day to 14-day maximum medication prescription.

Interventions: Patients were randomized into a control group which non-received any SMS reminder for medication using and an intervention group which received a SMS reminder everyday in mobile devices.

Primary Outcome(s) and Measure(s): The primary outcomes were compared patient medication adherence among experimental and control groups.

Eligibility Criteria:
Inclusion Criteria:

* Delayed or forgot to take medications over the last 3 days
* Received a min. 7-day medication prescription
* Able to receive SMS using mobile phones / devices
* 20 years or older
* Having intention to receive active treatment

Exclusion Criteria:

* Unable to receive SMS via mobile phones
* Illiterate and \< 20 years of age
* Received outpatient prescription drugs for ≤ 7 days
* External use, injections and traditional Chinese medicine
* Planned to go abroad
* Cold, cough, or prescribed with analgesics
Prehabilitation - Enhanced Recovery After Colorectal Surgery

The purpose of this study is to determine whether a combined cardiorespiratory and strengthening training prior to colorectal surgery decreases the rate of surgery-related complications.

This single site study investigates whether a preoperative training reduces the number and severity of perioperative complications in patients undergoing elective colorectal surgery according to the Enhanced Recovery After Surgery (ERAS) pathway.

The study will be approved by a local ethical committee and conducted in compliance with the protocol, the current version of the Declaration of Helsinki, the ICH-GCP as well as all national legal and regulatory requirements. Before inclusion informed written consent will be obtained from all patients.

Once the indication for the surgical intervention is given patients may be included into the study. Patients of the experimental group will be provided with a tailored training program aiming at maximally improving physical fitness in order to withstand the surgical stress. Depending on the urgency of the operation this training program will last between two and six weeks. Three weekly trainings are foreseen of which two will be performed in a setting supervised by a physiotherapist and one at the patient's home.

Patients assigned to the control group receive the usual care i.e. information about the upcoming procedure and the advice to remain physically active.

From the point of the operation both groups will be treated equally. Outcome measures will be obtained from the inclusion into the study up to one month after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥ 18 years) suffering from colorectal diseases needing an operative treatment and treated along our ERAS pathway
* Patients suffering from colorectal cancer, diverticulosis, benign tumors such as polyps or inflammatory bowel disease and surgically treated (i.e. rectosigmoid resection, anterior resection of rectum, ileocaecal/right hemicolectomy, left hemicolectomy, abdominoperineal resection or total/subtotal colectomy), and patients undergoing reversal of Stoma and Hartmann procedures will be included.
* Informed Consent as documented by signature

Exclusion Criteria:

* Patients suffering from severe dementia or other cognitive impairment, what hinders them to give informed consent
* Patients with a physical impairment, who can't perform the necessary physical Training
* Patients, who are not able or willing to attend the physical training at the institute of physiotherapy of the Kantonsspital Winterthur
* Inability of the participant to follow the procedures of the study, e.g. due to language problems, psychological disorders, etc.
* Participation in another study with investigational drug within the 30 days preceding and during the present study
* Enrolment of the investigator, his/her family members, employees and other dependent persons
Mass Evaluation of Lateral Flow Immunoassays for the Detection of SARS-CoV-2 (Covid-19) Antibodies

DESIGN Observational epidemiological study

AIMS - To determine:

1. The proportion of immunosuppressed people who have detectable SARS-CoV-2 antibodies following a primary vaccine course (3 doses), and the demographic, disease, and treatment characteristics that influence antibody status.
2. If the detection of antibodies inversely correlates with subsequent risk of severe acute respiratory syndrome coronavirus-2 infection and/or severity of disease in immunosuppressed people.

The aim of this proposal is to assess at a population level; 1) the proportion of immunosuppressed people who have detectable SARS-CoV-2 antibodies following a primary vaccine course (3 doses), and the sociodemographic, disease, and treatment characteristics that influence antibody status; 2) if the detection of antibodies inversely correlates with subsequent risk of SARS-CoV2 infection and/or severity of disease in immunosuppressed individuals.

The investigators aim to target patient groups least likely to mount an immune response to vaccination; a) solid organ transplant recipients; b) patients with a rare autoimmune disease c) patients with haematological malignancies, specifically lymphoid malignancies. The investigators will use comprehensive registries to identify and recruit patients from these groups, and utilise the existing linkages these registries already have to obtain COVID-19 outcome information.

The investigators hypothesise that a sizeable proportion of immunosuppressed people will have no detectable SARS-CoV-2 antibodies following a three vaccine doses, and that this cohort is particularly susceptible to SARS-CoV-2 infection and death.

Eligibility Criteria:
Inclusion Criteria:

Adults and young people over 12 years of age, and are classified as being part of one of the following patient groups:

1. A solid organ transplant recipient (n=12,000)
2. Patients with a rare autoimmune disease (n=12,000)
3. Patients with lymphoid malignancies (n=12,000) -

Exclusion Criteria:

-
The Efficacy of Combination of Traditional Tibetan and Remote Ischemic Conditioning on High Altitude Polycythemia

A multicenter, randomized controlled trial was designed to evaluate the effectiveness and safety of the comprehensive traditional Tibetan medicine program combined with remote ischemic conditioning on high altitude polycythemia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with high-altitude polycythemia aging 18 to 65 years.

Exclusion Criteria:

* Allergic to Tibetan medicine ingredients;
* Inappropriate to receive Tibetan medicine treatment and/or remote ischemic conditioning.
Effects of tDCS Combined With VR on Anxious Ruminations in Healthy Subjects With a Vulnerability to Rumination

This study proposes: to evaluate 1) whether the combination of virtual reality (VR) and active tDCS provides better rumination attenuation than the combination of VR and tDCS placebo 2) the acceptability and experiential experience of combining these two well known medical devices.

Inclusion visit:

* Confirmation of eligibility criteria
* Written informed consent

Visit 1 and 2 (or end of study visit) :

Before first ruminations induction :

* Completion of Brief State Rumination Inventory (BSRI), State-Trait Anxiety (STAI), Inventory, Visual Analogic Scale (VAS), Ruminative Response Scale - Short Form (RRS-SF), Beck depression Inventory (BDI)
* EEG recording

Then Procedure for inducing ruminations using a pre-recorded voice listened to in an audio headset alternating statements promoting a positive, neutral and negative introspection and self-judgment attitude (the latter are heard at the end to initiate the rumination process) over 8 minutes

Then

* Completion of Brief State Rumination Inventory (BSRI), Inventory, Visual Analogic Scale (VAS), Beck depression Inventory (BDI),
* EEG recording
* Pulse and blood pressure measurements

Then immersion in a relaxing virtual environment for 20 minutes with active or sham placebo.

• Cutaneous conductance measurement and eye-tracking during immersion

At the end of immersion :

* Completion of Brief State Rumination Inventory (BSRI), Inventory, Visual Analogic Scale (VAS), Beck depression Inventory (BDI), IGroup presence questionnaire (IPQ)
* Pulse and blood pressure measurements

Then again procedure for inducing ruminations .

At the end of ruminations induction :

* Completion of Brief State Rumination Inventory (BSRI), State-Trait Anxiety (STAI), Inventory, Visual Analogic Scale (VAS), Beck depression Inventory (BDI), tolerance questionnaires
* Debriefing

Eligibility Criteria:
Inclusion Criteria:

* Without any particular ethnic and psychosocial criteria
* Subject to ruminations (personality trait) documented by a RRS-SF score \>30
* Subjects with score to BDI scal \<14 assessed during first visit
* Subjects without psychiatric or addictive disorders.
* Subjects who do not meet all the diagnostic criteria for an anxiety disorder or characterized depressive episode.

Exclusion Criteria:

* contraindication to tDCS (neurosurgical history, intracranial device, skin problems)
* current virtual reality intolerance
* history of psychiatric or addictive disorders
* Use of psychotropic drugs
* Use of non psychotropic treatments significantly influencing mood or level of anxiety
* pregnant or breast-feeding women
* Neurological pathology, locomotor disability, or sensory (vestibular, visual, auditory ...)
Microvascular Dysfunction in Adults with Congenital Heart Disease and the Effect of Exercise Training

The goal of this prospective cohort study is to deepen the understanding of the pathophysiology in adults with congenital heart disease (CHD). Through this research, the investigators aim to identify potential strategies to improve the prevention and treatment of these patients. In this context, the effects of exercise training will also be assessed. The main questions it aims to answer are:

* Is coronary microvascular dysfunction (MVD) present in adults with diverse types of CHD?
* Is peripheral MVD present in adults with diverse types of CHD?
* Are coronary and peripheral MVD correlated in adults with diverse types of CHD?
* Is microvascular function correlated with inflammation and oxidative stress in adults with diverse types of CHD?
* Are inflammation and oxidative stress correlated with ventricular function in adults with diverse types of CHD?
* Are MVD and diminished ventricular function interrelated and associated with reduced exercise capacity in adults with diverse types of CHD?
* Does exercise training in adults with CHD result in improvements in coronary and peripheral microvascular function, inflammation and oxidative stress, biventricular function, muscle strength, exercise capacity and quality of life?

For the last research question, patients were randomized to receive either conventional care or home-based aerobic and strength exercise training.


Eligibility Criteria:
Inclusion Criteria:

* adults with congenital heart disease: as many different types of CHD as possible were incorporated
* New York Heart Association (NYHA) class I-II
* who visited the out-patient clinic at the Antwerp University Hospital

Exclusion Criteria:

* smoking
* body mass index \>35 kg/m²
* professional endurance athlete
* the presence of macrovascular coronary artery disease
* diabetes mellitus
* a systemic disease (e.g., malignancies, acute and chronic inflammatory diseases in the preceding 3 months)
* a contraindication for adenosine administration.
Reflexology's Effect on Polycystic Ovary Syndrome (PCOS)

Polycystic Ovary Syndrome (PCOS) is very common, affecting approximately 5% of women of reproductive age, and impacts not only on quality of life, but also has long-term health consequences for many sufferers, such as increased risks of developing Type II diabetes, cardiovascular disease and cancer of the womb. The symptoms that may occur such as irregular periods; lots of body hair; thinning hair on scalp, obesity and infertility, can also lead to poor self-esteem. Whilst treatments can help fertility, other treatments to correct the other symptoms are less successful. Alternative methods to regulate periods would be helpful, especially ones which avoid the long-term use of steroids in patients who may already be overweight. Reflexology is poorly represented in scientific papers, with nothing published regarding reflexology and its effect upon PCOS. However patients who use reflexology report more regular periods, thicker hair on scalp and greater wellbeing. Therefore we aim to investigate the effect of reflexology on:

1. The menstruation cycle (normal being every 21-35 days).
2. Imbalances in hormone, insulin and blood sugar levels associated with PCOS.
3. Other problems associated with PCOS such as thinning hair on scalp, excessive body hair, and obesity.
4. Quality of life. Government and NHS agendas agree that if there's evidence of an effective complimentary therapy the NHS should provide it. Therefore the results may have an influence on the care pathways of patients with PCOS towards a more holistic, patient centred and empowered approach. It is also non invasive and liable to result in higher patient satisfaction regarding their treatment. This research may also inform policy makers so that complementary medicine provision is provided on a wider basis within the NHS, which at the moment is dictated by the individual Trust's budget allocation. However this research could save money overall as in America, the yearly cost of treating PCOS is $4.36 billion.


Eligibility Criteria:
Inclusion Criteria:

* Women with PCOS

Exclusion Criteria:

* Use of complimentary therapies within 6/12 prior to recruitment
* BMI \>35
* Taken combined oral contraceptives, metformin, or cyclical progestogens within 3/12 prior to recruitment