cyrilzakka/clinical-trials huggingface dataset:
Effects of Sitagliptin on Type 2 Diabetes Mellitus Patients on Treatment With Metformin and Insulin

The purpose of the study is to determine the efficacy and safety of sitaglipin in the treatment of Type 2 diabetes mellitus (T2DM) patients with inadequate glycemic control using metformin and insulin.

DPP-4 inhibitors enhance function of endogenous incretin that helps with glucose homoeostasis. DPP-4 inhibitors have been proved to promote glycemic control without increasing risk of hypoglycemia and weight gain. In addition, they may improve beta-cell function and do not have any known associations with overt cardiovascular or hepatic safety risks.

Addition of sitagliptin to treatment of T2DM patients poorly controlled on insulin +/- metformin has been shown to reduce HbA1c while being generally well-tolerated.

It could be clinically useful to add sitaglipin to treatment regimen of T2DM patients on stable therapy with insulin \& metformin. Apart from glycemic reduction, secondary effects like prevention of weight gain, reduction in insulin dose, improved cardiovascular risk profile, etc. may be expected from addition of sitagliptin to treatment.

Eligibility Criteria:
Inclusion Criteria:

* T2DM patients on metformin and biphasic or basal regimens of insulin
* HbA1c ≥7.3% to ≤8.5%
* Age: 25 to 60 yrs
* Insulin TDD \> 10 IU

Exclusion Criteria:

* Use of acarbose, pioglitazone or short-acting insulin analogues at time of run-in phase
* History of type 1 diabetes mellitus
* Creatinine clearance ≤50 mL/min
* Chronic liver \& kidney diseases, SGOT/PT≥2.5x upper limit of normal, uncontrolled thyroid disorders , cardiac failure, hemochromatosis, autoimmune disorders, corticosteroid intake.
* BMI \>40 kg/m2
Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders

This study is being done to evaluate cutaneous nerve biopsies from patients with refractory gastrointestinal motility disorders. The purpose of the study is to evaluate skin biopsies for signs of small fiber neuropathy in GI dysmotility patients, which may provide a better understanding of the underlying pathology of their condition. Specifically, identifying any small fiber neuropathy that may exist in the peripheral nervous system may help us to better understand the mechanism of presumed enteric neuropathy that may be involved in causing GI dysmotility.

1. Gather basic, clinical information and perform small 3-6mm skin biopsies.
2. Identify characteristics of epidermal nerve fibers in patients with symptoms of gastrointestinal dysmotility
3. To isolate skin-derived precursor cells from skin biopsies and test their ability to generate neurons in vitro and in immune-deficient mouse models.

Eligibility Criteria:
Inclusion Criteria:

* Individual with a gastrointestinal motility disorder that has failed both clinical and surgical options for symptomatic management

Exclusion Criteria:

* Child 17 years of age or younger
* Individuals incapable of informed consent
* Patient with diseased skin or on drugs which affect skin biology.
Clinical Study to Evaluate the Maximum Tolerated Dose of BAY79-4620 Given Every 2 Weeks to Patients With Advanced Solid Tumors

Clinical study to determine safety, tolerability, to measure how the drug is metabolized by the body and to determine the maximum tolerated dose of BAY79-4620 given every 2 weeks to patients with advanced solid tumors


Eligibility Criteria:
Inclusion Criteria:

* The informed consent must be signed before any study specific tests or procedures are done
* Male or female patients aged \>18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
* Life expectancy of at least 12 weeks
* Patients with advanced, histologically or cytologically confirmed solid tumors, refractory to any standard therapy, have no standard therapy available, or patients must have actively refused any treatment which would be regarded standard, and/or if in the judgment of the investigator or his designated associate(s), experimental treatment is clinically and ethically acceptable
* Radiographically or clinically evaluable tumor
* Adequate bone marrow, liver, and renal functions as assessed by the following laboratory requirements to be conducted within 14 days prior to start of first dose

Exclusion Criteria:

* History of cardiac disease: congestive heart failure (CHF) \> NYHA Class II; myocardial infarction within 3 months prior to study entry; new onset angina within 3 months or unstable angina or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
* Uncontrolled hypertension defined as systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>95 mmHg, despite optimal medical management
* Symptomatic metastatic brain or meningeal tumors unless the patient is \>6 months from definitive therapy, has no evidence of tumor growth on an imaging study within 2 weeks prior to study entry, and is clinically stable with respect to the tumor at the time of study entry.
* Patients with severe renal impairment or on dialysis
* Known human immunodeficiency virus (HIV) infection or patients with an active hepatitis B or C infection necessitating treatment. Patients with chronic hepatitis B or C are eligible
* Active clinically serious infections of Common Terminology Criteria for Adverse Events Version 3 (CTCAE v3.0) \> Grade 2
* Serious, non-healing wound, ulcer, or bone fracture
* Major surgery, open biopsy, or significant trauma within 4 weeks prior to the first dose of study drug
* Anticancer chemotherapy, experimental cancer therapy, or immunotherapy within 2 weeks of start of first dose
* Radiotherapy to the target lesions within 3 weeks prior to Cycle 1 Day 1 (first dose of study drug). Palliative radiotherapy will be allowed as described in the study protocol. Radiotherapy to the target lesions during study will be regarded as progressive disease
A Study to Evaluate the Safety of MAX-40070 in Healthy Subjects

This is a First-in-Human phase I study to evaluate the safety, tolerability and pharmacokinetic characteristics of MAX-40070 in Healthy SubjectThe study will be comprised of 2 parts; Part A and Part B. Part A will be conducted at NZCR, and Part B will be conducted at both NZCR and another site(s) in China (if required). Part A will include approximately 48 participants, and Part B will include approximately 30 participants.


Eligibility Criteria:
Inclusion Criteria:

* Weigh at least 50kg (females) or 55kg (males) and have a BMI between 20.0 kg/m2 - 30.0 kg/m2.
* Subjects having no ulceration, damage, sunburn, redness, rash, acne, folliculitis, pigmentation, uneven skin tone, excessive freckles on the skin of the target application area and fever.

Exclusion Criteria:

* An abnormality related to the comprehensive physical examination, laboratory test, 12-lead ECG, and other diagnostic tests and which is determined by the investigator as clinically significant (CS).
* A history of CS diseases of heart, liver, lung, kidney, digestive tract, blood, or neuropsychiatric system.
* Intolerance to venipuncture for blood collection and/or having blood or needle phobia.
Does Concurrent Hydrocortisone With Venlafaxine XR Speed Antidepressant Response?

The primary purpose of this study is to examine whether IV hydrocortisone can speed up the time required for Venlafaxine XR to work.

Participants will be treated with Venlafaxine XR for 6 weeks. The dose of Venlafaxine XR will begin at 37.5 mg/day and be gradually increased to a maximum of 225 mg/day. The dose may be kept as low as 75 mg/day if necessary. Study doctor will be assessing mood to determine if some patients respond more quickly than the several weeks often required for an antidepressant to begin working. On the first day of treatment with Venlafaxine XR, participant will be randomly assigned (similar to a flip of a coin) to receive hydrocortisone 15 mg /day or placebo for two days. Placebo is an inactive substance, like a sugar pill. This dose of hydrocortisone is less than a typical replacement dose for patients who are not producing cortisol (hydrocortisone) naturally. The hydrocortisone is administered intravenously (in a vein) over the course of 2 hours for two consecutive days. Neither participant nor study doctor will know which treatment participant is receiving. However, this information is available to study doctor if it is needed.

Eligibility Criteria:
Inclusion Criteria::- outpatients at least 18 years of age

* current major depressive episode
* HDRS greater than or equal to 21
* good physical health Exclusion Criteria:- history of sensitivity, intolerance, or non-response to venlafaxine
* history of sensitivity to hydrocortisone
* history of bipolar 1 illness
* meets DSM-IV criteria for a current or past psychotic disorder
* meets DSM-IV criteria for substance abuse or dependence in previous 6 months
* significant imminent suicide risk
* medical condition that would compromise participation in the study
* woman of child bearing potential not using adequate birth control in the opinion of the investigator
London Asthma Diagnostics Study

The goal of this trial is to learn if the addition of oscillometry with reversibility testing increases diagnostic accuracy in adult asthma diagnosis, when added to current standard of care tests: spirometry with reversibility testing and Fractional Exhaled Nitric Oxide (FeNO). The main question it aims to answer is:

- Does oscillometry with reversibility testing increase diagnostic accuracy in detection of asthma in adults when added to spirometry with reversibility and FeNO?

Researchers will evaluate the diagnostic accuracy of this approach with the reference standard, which is a clinically adjudicated diagnosis of asthma by two respiratory clinicians based on history and investigation results.

Participants will

* Undergo oscillometry testing alongside their routine asthma investigations within their scheduled clinic visit
* Optionally participate in our sub-studies on new breath and nasal swab tests for asthma
* Optionally participate in our qualitative substudy on patients views and attitudes to asthma testing and oscillometry


Eligibility Criteria:
Inclusion Criteria:

* Patients referred by GP with either (a) possible incident asthma or (b) a diagnostic label of asthma without prior confirmatory objective diagnosis
* Age≥18 years
* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study
* Able to give informed consent

Exclusion Criteria:

* Age \<18 years
* A chest infection or exacerbation requiring antibiotics or steroids within 4 weeks of testing
* Contraindications to spirometry testing
* Established or coded diagnosis of COPD
* Pregnancy or lactating
* Other medical condition that in the opinion of the investigator would preclude compliance with the study protocoll
* Inability to understand English
* Involvement in Clinical Trial of an Investigational Medicinal Product
Evaluating the Association Between Changes in the Gut Microbiome, Fatigue, and Chemotherapy-Induced Nausea in Early Stage Breast Cancer

This pilot study seeks to understand how changes in the bacteria composition (microbiome) of the gut may be associated with the occurrence of fatigue and chemotherapy-induced nausea (CIN) in women undergoing chemotherapy for early stage breast cancer. Patients undergoing chemotherapy may experience fatigue or nausea as a result of their treatment. Known risk factors for fatigue and CIN do not explain the differences in fatigue and CIN occurrence between patients, but changes in the functions of the gut microbiome may be related to the occurrence of fatigue and CIN. This study collects stool samples from breast cancer patients before and after chemotherapy to evaluate how changes in the microbiome may be associated with fatigue and CIN.

PRIMARY OBJECTIVES:

I. Evaluate the feasibility of patient recruitment and retention, as well as specimen collection.

II. Estimate the effect size for changes in gut microbiome composition profiles and metabolites in stool as well as blood from time of first stool sample collection prior to chemotherapy (T1) to time of second stool sample collection after chemotherapy (T2) that are associated with the occurrence of fatigue and CIN.

III. Evaluate associations between patient reported demographic and clinical characteristics, comorbidities at T1, and changes in gastrointestinal and neuropsychological symptoms, food intake as well as exercise from T1 to T2 with the occurrence of fatigue and CIN.

OUTLINE: This is an observational study.

Patients undergo collection of stool and blood samples and complete questionnaires on study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of early stage breast cancer planning to receive moderate to highly emetogenic chemotherapy will be recruited at Mayo Clinic Health Systems including Mankato and Albert Lea; Mayo Clinic Arizona; Mayo Clinic Rochester (Minnesota); and Mayo Clinic Florida
* At least 20 years of age
* Last chemotherapy more than 3 years ago
* Scheduled to receive moderate to highly emetogenic chemotherapy with or without targeted therapies including immunotherapies

Exclusion Criteria:

* Metastatic disease
* Concurrent radiation therapy
* Concurrent antibiotic treatment
Lung Ultrasonography After Laparoscopic Gynecologic Surgery

This study evaluates the influence of surgical and anesthesia-related variable on atelectasis formation during laparoscopic gynecologic oncologic surgery by lung ultrasound.

Approximately 50% of patients undergoing general anesthesia are hypoxemic. Anaesthesia, paralysis, high concentrations of oxygen, inadequate level of PEEP, capnoperitoneum, Trendelenburg position all result in persistent atelectasis. Lung ultrasound is a safe and accurate bedside tool useful to study lung aeration. The aim of the investigator's study was to assess the impact of general anesthesia and laparoscopic gynecologic oncologic surgery on post-operative atelectasis and related oxygenation changes using lung ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 yo undergoing laparoscopic surgery for gynecologic surgery who provide written informed consent.

Exclusion Criteria:

* age \< 18 yo;
* pregnancy;
* refused to partecipate;
* known pulmonary metastasis;
* preexisting pulmonary conditions (COPD, pleural effusion, pulmonary consolidations, lung edema, pulmonary embolism);
* anesthesia with mechanical ventilation in the 2 weeks.
Biomarker Changes in Samples From Young Patients With Acute Myeloid Leukemia

RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the laboratory may help doctors learn about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarker changes in samples from young patients with acute myeloid leukemia.

OBJECTIVES:

* Map key histone modifications and cytosine methylation in leukemia cell lines with defined oncogenic mutations.
* Acquire genome-wide maps of key histone modifications and cytosine methylation for primary leukemia in samples from patients with acute myeloid leukemia (AML).
* Investigate functional relationships between genetic and epigenetic landscapes in AML.

OUTLINE: Archived samples are analyzed in vivo and in vitro (cell line) for histone modification and cytosine methylation. Genome-wide locations of 5 histone modifications are analyzed using chip-Seq, as well as DNA methylation analysis at nucleotide-resolution by high-throughput bisulfite sequencing. These epigenetic data are correlated with genomic data (sequence analysis, expression array, SNP array).

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia
* Primary leukemia samples from the Children Oncology Group (COG) bank with sufficient number of cells (500,000-1 million cells) with \> 80% of leukemia blasts

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Trial of 6% HES130/0.4

The study shall evaluate the efficacy and safety of two different hydroxyethyl starch solutions (artificial colloids 6% HES130/0.4 and 6% HES70/0.5, Salinhes®) for intra-operative therapy of hypovolemia and maintenance of circulating blood volume in patients undergoing orthopedic surgery. The primary efficacy endpoint will be the required volume of colloid solution infused from start until end of surgery. It is the aim of the clinical trial to demonstrate that comparable volumes of colloid solution are used between treatment groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an expected blood loss of ≥ 300 mL undergoing elective orthopedic surgery
* Patients with a body weight (BW) ≥ 50 kg

Exclusion Criteria:

* Known or suspected allergy to hydroxyethyl starch, including its ingredients (inclusive corn) and related drugs
* ASA classification ≥ IV
* Renal disease (serum creatinine ≥ 2mg/dL)
* Known bleeding disorders
* Congestive heart failure
* Fluid overload
* Intracranial bleeding
* Severe hypernatremia
* Severe hyperchloremia
Effectiveness of Dual Task Training in Total Knee Arthroplasty

This study was planned to investigate the effectiveness of usual care and dual task program in patients who underwent total knee arthroplasty surgery. It is aimed to evaluate pain intensity, disability level, mini mental status, coordination, reaction time and functional status of the patients. The study will be conducted with volunteer patients who are followed up by the Orthopedics and Traumatology outpatient clinic of Bursa Cekirge State Hospital and who have undergone total knee arthroplasty surgery. It is aimed to evaluate at least 26 patients for the study. The first evaluation will be performed 6 weeks post-operatively and the second evaluation will be performed 2 months after the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Having undergone unilateral total knee arthroplasty surgery and being 6 weeks postoperative
* Participate in all necessary follow-up assessments
* 60 years of age or older
* Understand simple commands
* Signing the consent form

Exclusion Criteria:

* A previous history of total knee arthroplasty
* Presence of revision surgery
* Presence of severe osteoarthritis in the contralateral knee
* Severe acute metabolic neuromuscular and cardiovascular diseases
* Extreme obesity (bmi\>35)
* Presence of malignancy
* Have any other orthopedic or neurological problem that may affect treatment and assessments
* Situations that prevent communication
* Lack of cooperation during the study
Combination of Strength and Sensorimotor Training

AIM:

Strengthening and sensorimotor training (e.g with the aim to improve balance) are widely used in rehabilitation. There is little knowledge about the best ways to combine strengthening and sensorimotor training. Therefore, the investigators want to evaluate two types of combinations in healthy participants.

Interventions:

* Group A: 1.) warm-up; 2.) sensorimotor training; 3.) strength training (nine sessions in four weeks)
* Group B: 1.) warm-up; 2.) one strengthening exercise, followed by a sensorimotor exercise, alternating (nine sessions in four weeks)

Tests (Before first training and after four weeks):

* isokinetic test of knee extensors and flexors (60°/s; 120°/s; 180°/s; 240°/s.)
* squat jumps and countermovement jumps
* static balance test on an unstable underground (measured with accelerometer)
* dynamic balance: star excursion balance test, (a) on stable ground, (b) on unstable ground. Balance tests will be performed (c) in recovered state and (d) fatigue (i.e. after a fatiguing exercise).

Hypotheses

1. Group B (alternating sensorimotor and strength exercises) will improve more in the balance tests than Group A (sensorimotor first, strength afterwards).
2. Group B will improve more in the countermovement jump than Group A.
3. There will be no differences in the improvements in the strength, power and squat jump tests between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Able to perform strength and sensorimotor training
* At least 18 years old

Exclusion Criteria:

* Injury that does not allow training and testing
* Illness that does not allow training and testing
* Pregnancy
* Pain during exercising
Association Between Inflammatory Biomarkers in CVD Patients on Empagliflozin.

The association of novel inflammatory biomarkers with cardiovascular diseases is still obscure. The present study aimed to investigate the relationship of various inflammatory biomarkers with the existence as well as the extent of heart failure (HF) and coronary artery disease (CAD), suggesting a link between inflammation and cardiovascular diseases and all-cause 30- and -90 day of hospital readmission. Methods: We enrolled a total of 120 patients with HF, asymptomatic CAD and 60 healthy controls (HC) without cardiovascular diseases.

* The present study aimed to investigate the relationship of various inflammatory biomarkers with the existence as well as the extent of heart failure (HF) and coronary artery disease (CAD), suggesting a link between inflammation and cardiovascular diseases and all-cause 30- and -90 day of hospital readmission in patients on empagliflozin 10 mg once daily for 6 months before the beginning of the study.
* We enrolled a total of 60 patients with HF, 60 asymptomatic CAD patients and 60 healthy controls (HC) without cardiovascular diseases.

Group I: 60 Healthy Subjects. Group II: 60 Patients with Stable Angina (asymptomatic CAD). Group III: 60 Patients with Heart Failure.

* Clinical parameters, glycemic and lipid profile, vaspin, visfatin, high-sensitivity C-reactive protein, sortilin, homocysteine, troponin I, fetuin A and lipoprotein A levels were assayed.
* Patients will be followed up to assess all-cause 30- and -90 day of hospital readmission.

Eligibility Criteria:
Inclusion Criteria:

* Either sex, aged 18 years or older.
* new-onset AHF or acute decompensation of chronic HF,
* CAD (including previous myocardial infarction, previous percutaneous or surgical coronary revascularization, or angiographic evidence that one or more major coronary arteries had narrowed by 50% or more).
* On empagliflozin 10 mg once daily for 6 months before the beginning of the study.

Exclusion Criteria:

* severe liver/
* kidney dysfunction;
* severe systemic disease (such as the diseases of respiratory system/ digestive system/ nervous system etc.);
* malignant tumor;
* acute/ chronic infectious diseases;
* autoimmune disease or connective tissue disease;
* major trauma or surgical operation over the past three months.