cyrilzakka/clinical-trials huggingface dataset:
Purified Anthocyanins Supplementation in Type 2 Diabetes Mellitus

Anthocyanins, the water-soluble compounds that make plants appear different colors, have been shown to prevent insulin resistance, reduce the blood glucose and oxidative stress in rodents. The purpose of our study is to evaluate a potential protective effect of purified anthocyanins supplement on type 2 diabetes mellitus patients.

The study was designed as a randomized, double-blind label, interventional study on patients with T2DM. The eligible Participants are randomly assigned to control and Anthocyanins supplement group. During the 12 weeks trial period,the participants were instructed to consume two anthocyanin capsules or placebo capsules twice daily (30 min after breakfast and supper).

Eligibility Criteria:
Inclusion Criteria:

* Subject is diagnosed with type 2 diabetes mellitus according to the Chinese type 2 diabetes prevention guide 2010, diagnostic criteria are as follows:(1) Diabetes symptoms (polydipsia, polyphagia, polyuria, weight loss, skin itching, blurred vision and other acute metabolic network disorder that caused by high blood sugar)combined with random blood sugar ≥11.1 OR,(2)fasting plasma glucose(FPG)≥7.0 OR (3)2h blood sugar after oral glucose tolerance test(OGTT)≥ 11.1
* Subject is between 25 and 75 years of age, inclusive.
* Subject BMI is ≥18.5 kg/m2 and ≤35 kg/m2

Exclusion Criteria:

* Subject that is diagnosed as type 1 diabetes, gestational diabetes and other kinds of diabetes expect type 2.
* Subject that use exogenous insulin for glucose control.
* Subject that has a history of diabetic ketoacidosis.
* Subject that has coronary artery disease, mental disorder, cancer, cirrhosis, renal disease and hepatic disease.
* Subject that has had operation less than six months prior to screening visit.
* Subject that uses supplementation with vitamins or antioxidants.
Efficacy of an Assisted Therapy Optimizing Module to Improve Physician Adherence

Heart failure patients within the HM programme

A prospective, randomized, multi-sectoral multi-centre study with parallel group design.

Application of guideline-directed medical therapy (GDMT) improves quality of life and decreases hospitalization for heart failure and mortality.

GDMT is in general underused. This also applies to patients who are cared for in the integrative, telemedicine-supported disease management program Herzmobil Tirol (HMT). The Assisted Therapy Optimizing Module has been designed to actively assist network physicians in adhering to and improving guideline-based medical therapy.

Eligibility Criteria:
Inclusion Criteria:

AMPEL, CIP, Version: 1.2 Date: 27.03.2024

1. Written, signed and dated informed consent for inclusion in the HM programme
2. Male and female patients over 18 years of age.
3. Hospitalised for decompensated heart failure requiring intravenous diuretics
4. Need for iv diuresis in nonhospital setting because of impending hospitalization for cardiac decompensation

Exclusion Criteria:

1. Multimorbidity (Charlson Comorbidity Index \> 6)
2. Dementia
3. Lack of willingness to participate
Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

This protocol is a prospective, open-label, multicenter, population pharmacokinetic and pharmacodynamic study of selected anti-infective agents in pregnant women being treated for suspected or documented infections.


Eligibility Criteria:
Inclusion Criteria:

* Women in their second or third trimester of pregnancy
* Women currently receiving treatment or whose physician has made the decision to start treatment with ciprofloxacin, azithromycin or gentamicin for a suspected or documented infection
* Of childbearing potential and who either have never been pregnant or whose most recent pregnancy ended 3 months previously (control group)
* Women greater than 3 months postpartum and currently breast-feeding (substudy)

Exclusion Criteria:

* Women with significant gastrointestinal disease which may be expected to interfere with the absorption of the orally administered anti-infective agents
Rituximab Combined With Cyclosporine Versus Rituximab Alone in the Treatment of iMN

The primary objective of this study is to determine whether or not cyclosporine (CsA) combined with RTX is more effective than RTX alone in the treatment of idiopathic membranous nephropathy (iMN).

To date, the first-line immunosuppressive therapy of iMN includes corticosteroids combined with cyclophosphamide or Rituximab (RTX) which has been used more and more widely due to superior safety profiles. But the long term remission rate of RTX monotherapy is only 60% and it takes effect relatively slowly.

2 pilot studies reported that the combination therapy of cyclosporine (CsA) and RTX had better efficacy for inducing remission for iMN, with the long term remission rate up to 85%. CsA and RTX may have synergistic effect in the treatment of iMN because they have different time of action and different effects on the immune system and podocytes.

Based on the previous rationale, the investigators designed this trial to determine whether combination of CsA and RTX is more effective than RTX alone in the treatment of iMN.

Eligibility Criteria:
Inclusion Criteria:

* idiopathic MN with or without diagnostic biopsy
* Female, must be post-menopausal, sterile or have effective method of contraception
* must be off steroid or mycophenolate mofetil for \>1 month and alkylating agents for \> 6 months
* Angiotensin-converting-enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for ≥3 months prior to randomization with controlled blood pressure or if patients is intolerant to ACEI/ARB
* proteinuria ≥4g/24h using the average from two 24-hour urine samples collected within 2 weeks of each other, and decreased ≤50% from baseline.
* estimated glomerular filtration rate (eGFR) ≥40ml/min/1.73m2

Exclusion Criteria:

* presence of active infection or a secondary cause of MN
* diabetes mellitus: to exclude proteinuria secondary to diabetic nephropathy.
* pregnancy or breast feeding
* history of resistance to CsA or other calcineurin inhibitors(CNI), RTX or alkylating agents.
* Patients who previously achieved remission after treatment of CNI, RTX or alkylating agents but relapsed off CNI after 3 months, or relapsed off RTX or alkylating agents after 6 months, are eligible.
Endpoint Validation Study (0524A-015)

To determine the most effective daily dose of MK0524A when compared with placebo after the 8-week treatment period for Niacin Induce Flushing (NIF).


Eligibility Criteria:
Inclusion Criteria:

* Patients must be male or female between 18 to 70 years
* Qualified women must be sterile (through surgery) and/or post-menopausal, and/or agree to use birth control

Exclusion Criteria:

* You are a woman who is having hot flashes, receiving Hormone Replacement Therapy (HRT), and/or other therapies for hot flashes
* You are currently using Niacin/or Niacin containing products with a daily dose over 50 mg/day
* You are sensitive to niacin
* You have a history gout
* You drink more than 2 glasses of alcohol per day and you are not willing to stop
* You don't have access to a telephone
Temozolomide in Treating Patients With Low-Grade Glioma

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with supratentorial low-grade glioma.

OBJECTIVES:

Primary

* Determine the efficacy of temozolomide, defined as response rate (complete and partial response), in patients with supratentorial mixed low-grade glioma.

Secondary

* Assess the safety profile of temozolomide in patients with supratentorial low-grade glioma.
* Assess the time to tumor progression in patients treated with temozolomide.

OUTLINE: Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven supratentorial low-grade (grade II) glioma of any of the following histologic subtypes:

  * Oligodendroglioma
  * Astrocytoma
  * Oligoastrocytoma
* Has undergone surgical resection or biopsy within 35 days after diagnosis of low-grade glioma

  * Study treatment must begin between 14 days and 4 months after surgical resection or biopsy
* Evaluable disease by gadolinium-MRI

PATIENT CHARACTERISTICS:

* Karnofsky performance status 60-100%
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10 g/dL
* Creatinine \< 1.5 times upper limit of normal (ULN)
* BUN \< 1.5 times ULN
* Bilirubin \< 1.5 times ULN
* SGOT \< 2.5 times ULN
* Alkaline phosphatase \< 2 times ULN
* Life expectancy \> 12 weeks
* No nonmalignant systemic disease resulting in the patient being a poor medical risk
* No acute infection requiring intravenous antibiotics
* No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction)
* No other concurrent malignancies except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin

  * Prior malignancies must be in remission for ≥ 5 years
* No known HIV positivity
* No AIDS-related illness
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior radiotherapy, interstitial brachytherapy, or radiosurgery for low-grade glioma
* No prior biological therapy or chemotherapy for low-grade glioma
* No other concurrent chemotherapy
* No concurrent radiotherapy or biological therapy
* No concurrent prophylactic growth factors
* No concurrent epoetin alfa
* No other concurrent investigational drugs
Copeptin Registry (proCORE) Biomarkers in Cardiology (BIC)-19

Registry of an interventional Study-proved Strategy (BIC-8) using Copeptin and Troponin for the Early Rule-Out of Acute Myocardial Infarction (AMI) in Patients with Suspected Acute Coronary Syndrome (ACS) and a low-to intermediate risk profile.

Registry of an interventional Study-proved Strategy (BIC-8) using Copeptin and Troponin for the Early Rule-Out of Acute Myocardial Infarction (AMI) in Patients with Suspected Acute Coronary Syndrome (ACS) and a low-to intermediate risk profile.

Primary objective:

To monitor the safety of the early rule-out strategy using combined testing of copeptin and troponin at admission of patients with signs and symptoms suggestive of ACS and a low- to intermediate risk profile, who are discharged or moved to another hospital after testing copeptin and troponin negative (defined as copeptin below 10 pmol/l and cardiac troponin below 99th percentile URL).

Secondary objectives:

* To monitor routine application of the early rule-out strategy, patient characteristics, risk profile of all patients tested for copeptin and troponin at admission, irrespective of their biomarker test result
* To monitor diagnoses, clinical course and outcome of all patients tested for copeptin and troponin at admission

Eligibility Criteria:
Inclusion Criteria:

* Admission to the Emergency Department or CPU with signs and symptoms consistent with acute coronary syndrome
* Low-to intermediate risk profile (GRACE-score below 140 and a low- to intermediate likelihood of ACS as judged by the treating physician)
* Patients eligible for the early rule-out strategy using combined copeptin and troponin testing at admission, irrespective of biomarker test results and disposition decision
* full-aged patient

Exclusion Criteria:

* none
Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer

GEMINI-Hepatobiliary study will assess the efficacy, safety and tolerability of novel immunomodulators alone and in combination with other anticancer drugs in participants with specified advanced solid tumors.

This Phase II, open-label, uncontrolled, multicentre study evaluating the preliminary efficacy and safety of Volrustomig or Rilvegostomig as monotherapy (MONO) and/or in combination with anticancer agents (COMBO) in participants with advanced hepatobiliary cancer (e.g., HCC, BTC, etc.).

This study has a modular design with independent substudies. In Substudy 1, Volrustomig and Rilvegostomig will be evaluated as monotherapy and/or in combination with other anticancer drugs in approximately 200 evaluable participants with advanced HCC.

In Substudy 2, the efficacy and safety of Rilvegostomig or Volrustomig plus gemcitabine and cisplatin are investigated in approximately 60 evaluable participants with advanced BTC who have not received previous treatment for advanced/metastatic disease.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years at the time of signing the ICF.
* Provision of a signed and dated written ICF.
* Confirmed locally advanced or metastatic solid tumor specified in substudy based on histopathology.
* Adequate organ and bone marrow function.
* At least 1 measurable not previously irradiated lesion per RECIST 1.1
* Life expectancy of at least 12 weeks at the time of screening.
* Willing and able to provide an adequate tumor sample.

Exclusion Criteria:

* History of allogeneic organ transplantation.
* Active or prior documented autoimmune or inflammatory disorders.
* Uncontrolled intercurrent illness.
* History of another primary malignancy, leptomeningeal carcinomatosis, and active primary immunodeficiency.
* Active infection, brain metastases or spinal cord compression.
* Participants co-infected with HBV and hepatitis D virus (HDV).
* Previous treatment in the present study.
* For substudy 1, history of hepatic encephalopathy within 12 months prior to treatment allocation.
A Study to Learn More About How Drug Aflibercept Works in Canadian Patients With Reduced Vision Caused by New Blood Vessels Growing in the Eye (Myopic Choroidal Neovascularization or mCNV)

Being short sighted means that vision is blurry when looking at things far away. People with a condition called "pathologic myopia" are short sighted due to problems in the back layer of their eyes, also known as the retina. Some people with pathologic myopia can develop a serious condition called myopic choroidal neovascularization (mCNV). In people with mCNV, new blood vessels grow into the retina. These blood vessels can break, leaking blood or fluid into the retina. This can cause blurry vision or a loss of vision.

In this study, researchers will find out more about how well drug aflibercept works and how safe it is in Canadian patients with mCNV.

The researchers in this study will review information from the patients' eye doctor visits. The patients in this study will include Canadian men and women who started receiving aflibercept between May 2017 and August 2019. These patients were at least 18 years old and had not received treatment for their mCNV before.

The researchers will look at the results of vision tests to find out how well the patients could read from a distance after they received aflibercept for 6 months. They will compare the results of these tests to before the patients received treatment. They will also learn more about how safe it is to have aflibercept injection into the eye.


Eligibility Criteria:
Inclusion Criteria:

* Adult (Age ≥ 18 years) female or male patient.
* Anti-VEGF treatment naïve patients diagnosed with mCNV.
* Initiation of treatment with aflibercept was made as per investigator's routine treatment practice between 01 MAY 2017 and 31 AUG 2019.

Exclusion Criteria:

* Any participation in an investigational program with interventions outside of routine clinical practice.
* Patients who have previously been treated with anti-VEGF intravitreal injections, systemic anti-VEGF or pro-VEGF treatments, as well as other intravitreal steroids or steroid implants for the study eye.
* Patients with another retinal disease (e.g. wet age-related macular degeneration,-wAMD; diabetic macular edema-DME; retinal vein occlusion-RVO), patients with advanced cataracts or glaucoma, or patients with scarring, fibrosis, or atrophy involving the center of the fovea.
Social Facilitation of Emotion Regulation in Adolescence

The goal of this project is to test whether regulating emotions with help from a friend is more effective and long-lasting in adolescents than regulating alone, and to characterize age-related differences in the neural mechanisms supporting social versus cognitive emotion regulation. Participants will complete a psychology experiment while undergoing fMRI scanning.

Participants will complete a novel paradigm during functional magnetic resonance imaging (fMRI) to examine whether adolescents (N = 50) and adults (N = 50) are more effective at down-regulating negative affect when a friend provides them with reinterpretations of negative stimuli (i.e. social reappraisal), as compared to when they reinterpret stimuli alone (i.e., cognitive reappraisal). Specifically, participants will look at pictures of upsetting events while undergoing fMRI scanning. For some pictures, they will be instructed to just look at the image. For other pictures, they will be told to listen to their friend's voice as their friend helps them to regulate their emotions. For other pictures, they will be told to regulate their emotions on their own. The primary comparison of interest is how participants regulate emotion on their own versus when their friend helps them.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent participants must be 13-15 year of age
* Adult participants must be 20-25 years of age
* Proficient in English

Exclusion Criteria:

* Auditory, visual or cognitive impairment
* Any health conditions that are contraindicated for MRI
Onabotulinum Dose Comparison in Chronic Migraine Superior to 100 Units?

The study will enroll patients through the Neurology Department at Naval Medical Center San Diego (NMCSD). Eligible participants will meet criteria for chronic migraine, but will not be excluded based on the presence of significant comorbidities. Participants with comorbidities and medication regimens commonly exhibited within real-world DOD medical settings will not be excluded, such as pain disorders, psychiatric illness, medication overuse, and those who have used prophylactic medication during the baseline period.

This will comprise "Group A". A carefully screened group will comprise "Group B" and meet exclusion criteria designed to approximate that of the PREEMPT2 trial. Within each group, half of the patients (155U Arm) will be randomly selected to receive the standard 155U over 31 fixed sites every 12 weeks while the other half (100U Arm) will receive 100U over 19 fixed sites every 12 weeks. Minimum sample size for the entire cohort is 132 participants (maximum n = 180), with a minimum of 66 participants per comparison.


Eligibility Criteria:
Inclusion Criteria:

Chronic migraine headache - Diagnostic criteria:

A. Headache (tension-type-like and/or migraine-like) on 15 days per month for \>3 months2 and fulfilling criteria B and C B. Occurring in a patient who has had at least five attacks fulfilling criteria B-D for 1.1 Migraine without aura and/or criteria B and C for 1.2 Migraine with aura

C. On 8 days per month for \>3 months, fulfilling any of the following 3 :

1. criteria C and D for 1.1 Migraine without aura
2. criteria B and C for 1.2 Migraine with aura
3. believed by the patient to be migraine at onset and relieved by a triptan or ergot derivative D. Not better accounted for by another ICHD-3 diagnosis. -

Exclusion Criteria:

Previous exposure at any time to any botulinum toxin serotype Pregnancy, breastfeeding or plans to become pregnant within 6 months Age \<18 years Failure to complete at least 20 days of headache diary in the 28 day baseline period
Study to Assess Adverse Events and Compare How Oral Ubrogepant and Oral Atogepant Moves Through the Body of Healthy Female Adult Volunteers

This study will assess adverse events and compare how ubrogepant and atogepant tablets move through the body of healthy adult lactating female participants.

Ubrogepant and atogepant are approved drugs for treatment of migraine in adults. Participants will be assigned to one of the 2 treatment arms to receive atogepant or ubrogepant. Approximately 24 healthy adult lactating female participants will be enrolled at 3 sites in the United States

Participants will receive oral tablets of ubrogepant or atogepant on Day 1 and will be followed for 30 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, lactating, female volunteers who delivered one or more normal-term infants and established lactation from 1 - 6 months post-partum at the time of enrollment.
* Had a normal pregnancy (gestation of 37-42 weeks) with no clinically significant complications.
* Willing to permit the use of pasteurized donor milk, infant formula, or previously pumped/stored human milk to feed the infant.
* Agree to the use of provided breast pumps for the pumping of breast milk during the milk collection regimen of the study.

Exclusion Criteria:

- Prior exposure to ubrogepant or atogepant within the past 30 days.
TNS for Treating Nicotine Craving

Electrical stimulation provides direct modulatory effects on subcortical regions. Indeed, neuroimaging studies show changes in neural activity in specific brain regions such as the amygdala, insula, precentral gyrus, hippocampus and thalamus. The neuroanatomical connections established with the trigeminal nerve have been associated with the mechanism called "bottom-up" neuromodulation. According to this hypothesis, the spread of electrical stimulation follows a path from the peripheral nerves towards the brain stem was then advertise for cortical and subcortical regions. Connections to structures involved in the reward system as the amygdala and hippocampus could theoretically modulate dysfunctional brain activity in these regions, which may induce favorable clinical effects.


Eligibility Criteria:
Inclusion Criteria:

1. patients over 18 years
2. both genres
3. diagnosed with nicotine related disorder for at least 12 months according to the diagnostic criteria of DSM-IV administered by a psychiatrist.
4. Also we will adopt as inclusion criteria a score of Nicotine Dependence Fagerstrom Test greater or equal to 5 points.
5. Finally, patients should be able to read and understand the portuguese language.
6. Patients will be selected from spontaneous demand. In accordance to informed consent -

Exclusion Criteria:

1. other psychiatric diagnosis such as bipolar Affective Disorder, alcohol dependence, schizophrenia and dementia.
2. Also excluded patients with severe neurological or medical diseases, such as neurodegenerative diseases, stroke, cancer in activity, congestive heart failure or chronic obstructive pulmonary disease stage III or IV.
3. Finally, patients with severe suicidal ideation (structured planning suicide or attempted suicide in the past 4 weeks) will be excluded. In this case, the patient will be seen immediately by a psychiatrist of the research itself that will take the appropriate clinical management according to the severity of suicidal thinking.

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