cyrilzakka/clinical-trials huggingface dataset:
Phase III Study for Glimepiride + Metformin Hydrochloride (Amaryl M) Slow Release (SR)

Primary:

To show the equivalence in terms of efficacy glycated hemoglobin (HbA1c) of glimepiride/metformin slow-release combination tablet (Amaryl M SR 2/500) once daily compared with fixed-dose glimepiride/metformin combination tablet (Amaryl M 1/250) twice a day on HbA1c in patients with type 2 Diabetes Mellitus (DM)

Secondary: To compare the following parameters in two treatment arm

* Efficacy; Fasting Plasma Glucose (FPG) and Post-prandial two hours plasma glucose (PP2h)
* Response rates in terms of HbA1c, FPG
* Patient compliance

Safety:

* episodes of hypoglycemia
* adverse events
* laboratory values including hematology blood chemistry and urinalysis
* vital sign and physical examination


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 DM diagnosed for at least 3 months but no longer than 10 years before screening;
* - BMI ≤ 40 kg/m²;
* A negative pregnancy test for all females of childbearing potential

Exclusion Criteria:

* A history of acute metabolic complications such as diabetic ketoacidosis or hyperosmolar nonketotic coma within 3 months before screening;
* Current therapy with any oral anti-diabetic drugs or previous use in the 4 weeks other than sulfonylureas or metformin (8 weeks in case of thiazolidinedione) before screening;
* Concomitant treatment prohibited during the study period;
* Any oral anti-diabetic drugs other than study medication
* Any insulin therapy over 7 days consecutively or intermittently in order to treat acute metabolic decompensation or systemic infection during the study
* Intermittent use of systemic corticosteroids or large dose of inhaled steroids
* Subjects with clinically significant renal (serum creatinine level \>1.5 mg/dL in male and \>1.4 mg/dL in female) or hepatic disease (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>2x upper limit of normal (ULN));
* Subjects with acute and severe cardiovascular disease (e.g. heart failure, myocardiac infarction, stroke etc.)
* Clinically significant laboratory abnormality on screening labs or any medical condition that would affect the completion or outcome of the study in the opinion of the investigator and/or sponsor;
* Pregnant or lactating females;
* History of drug or alcohol abuse;
* Subjects with known hypersensitivity to glimepirides, or metformin; Night-shift workers;
* Treatment with any investigational product in the last 3 months before study entry;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Effects of Chronic Use of Doxazosin in Men With Benign Prostatic Hyperplasia

In this study, we investigate the changes of the expression of alpha adrenergic receptor in the prostate tissue during 2-yr medication period in the man with benign prostatic hyperplasia. And we also evaluate the efficacy and safety of 24 mo-treatment with doxazosin (4mg, 8mg)

To compare the expression of alpha-1 adrenergic receptors, we will use various methodologies such as

* Real-time RT-PCR
* Radioligand receptor binding
* Western blot
* Immunohistochemistry

Eligibility Criteria:
Inclusion Criteria:

* 50 yrs or greater
* International prostatic symptom score \>= 8
* Maximal flow rate \< 15mL/sec
* baseline PSA 2.5-10 ng/mL
* Pathologically proven BPH
* No medication history for BPH
* Able to give fully informed consent

Exclusion Criteria:

* Previous use of alpha-blocker, 5-alpha reductase inhibitor
* Previous surgery for BPH
* Urologic cancer history
* Urethral stricture
* baseline PSA \> 10ng/mL
* BP \< 90/70 mmHg
* Orthotopic hypotension with syncope
* Serum Cr \> 2.0 mg/dl, alanine aminotransferase \> 1.5 times of normal limit
* Bacterial prostatitis within 1 year
* Urinary tract infection(UTI) more than 2 times within 1 year
* Active UTI or prostate biopsy within 1 month
* Unable to void
* Ped use because of incontinence
* Hypersensitivity to alpha-blocker that include quinazoline
* Unstable angina, Myocardial infarction, or cerebrovascular accident within 6 months
* Neurogenic bladder dysfunction (ex. multiple sclerosis, Parkinson's disease, Spinal injury etc.)
* Psychiatric problem
* Alcohol abuse or other drug abuse history
* Severe comorbidities unable to perform long-term trial
* seems not to be appropriate to this study because of any other reasons
Safety and Efficacy of Sugammadex (Org 25969, MK-8616) in Participants With or Having a Past History of Pulmonary Disease (19.4.308) (P05932) (MK-8616-017)

The purpose of the trial is to research the safety and to show faster recovery after administration of 2.0 mg/kg or 4.0 mg/kg sugammadex (Org 25969, MK-8616) given as a reversal agent for 0.6 mg/kg (0.15 mg/kg maintenance dose) rocuronium (Zemuron®) in participants diagnosed with or having a history of pulmonary disease. All drug administration will be via the intravenous (IV) route.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Class 1 to 3;
* Has been diagnosed with or having a past history of pulmonary disease;
* Is scheduled for elective surgical procedure under general anesthesia requiring neuromuscular block with the use of rocuronium;
* Is scheduled for surgery in supine position;
* Has given written informed consent;

Exclusion Criteria:

* Is expected to have a difficult intubation due to anatomical malformations;
* Has known or suspected of having neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction;
* Has known or suspected of having a (family) history of malignant hyperthermia;
* Has known or suspected of having an allergy to narcotics, muscle relaxants or other medications used during surgery;
* Is receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and Mg2+;
* Is a female who is pregnant or breast-feeding;
* Is a female of childbearing potential not using an acceptable method of birth control \[condom or diaphragm with spermicide, vasectomized partner (\> 6 months), IUD, abstinence\] or using only hormonal contraception as birth control;
* Has already participated in a sugammadex trial including Protocol 19.4.308;
* Has participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.308.
A Clinical Trial of A Pacifier-Activated Music Player

Neonatal intensive care unit infants are at high risk for oromotor difficulties including poor coordination of sucking swallowing and breathing. These feeding difficulties often result in prolonged hospitalization, with increased physiologic stressors and poor growth. In preliminary studies, Pacifier Activated Lullaby (PAL) use showed potential increased oromotor skills and decreased length of hospitalization.

The investigators propose to test the hypothesis that a week-long PAL intervention can improve feeding skills and decrease stress compared to standard of care parental interactions in infants in the late preterm period. The investigators also hypothesize that these improvements will result in shorter hospital stays and increased growth in the intervention group.

Our study design is a prospective randomized controlled trial design of 94 infants (Post-conceptional ages 34-36 weeks). The 47 intervention-group infant/mother dads will receive a book library with one lullaby book and record her voice to the PAL, which the music therapist will then administer in 15-minute sessions for 5 consecutive days. The 47 participants in the control group will receive the same library but no recording will be made or PAL used. Outcomes measured will include time to full oral feeds, suck rate and efficiency, salivary cortisol levels before and after intervention, daily growth parameters and nutritional data, and hospital length of stay.

Objectives: We conducted a randomized trial to test the hypothesis that the mother's voice played through a pacifier-activated music (PAM) player during nonnutritive sucking would improve the development of sucking ability and promote more effective oral feeding in preterm infants.

Methods: Preterm infants between 34 0/7 and 35 6/7 weeks postmenstrual age, including those with brain injury, who were taking at least half their feedings enterally and less than half orally, were randomly assigned to receive 5 daily 15-minute sessions of either PAM with mother's recorded voice or no PAM, along with routine nonnutritive sucking and maternal care in both groups. Assignment was masked to the clinical team.

Eligibility Criteria:
Inclusion Criteria:

* All infants at 34 0/7 to 35 6/7 weeks post-conceptional age cared for in the Vanderbilt NICU who are receiving more than 50 % of their nutrition as enteral feeds, and are in individual rooms or in the room with their sibling.

Exclusion Criteria:

* infants on ventilators or Continuous Positive Airway Pressure (CPAP),
* infants determined to be unsafe to feed orally by the medical team or the feeding/speech specialists at Vanderbilt.
The Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment

To explore the efficacy and safety of CDK4/6 inhibitors combined with endocrine neoadjuvant therapy for stage II-III HR-positive/HER2-negative breast cancer.

This study adopts a single-arm, open-label design, and plans to include 40 patients with stage II-III HR+/HER2- breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old.
2. Premenopausal and postmenopausal stage II-III females or males (patients with multicenter and/or multifocal early-invasive breast cancer) if all histopathological examination of tumors meet the pathological criteria of ER and/or PR\>10% and HER2- (HER2 expression 0 or 1+ or 2+ and negative FISH test).
3. Patients must have histologically confirmed ER and/or PR \>10%, HER2-, early invasive breast cancer.
4. Intolerance or insensitivity to neoadjuvant chemotherapy: 2 cycles of neoadjuvant chemotherapy, tumor evaluation PD/SD, advanced age, and inability to tolerate chemotherapy with underlying diseases.
5. ECOG PS score 0-2.
6. Patients must be able and willing to swallow and retain oral medications.
7. Premenopausal women within 14 days of enrollment, or women with amenorrhea for less than 12 months at the time of enrollment, must have a negative serum or urine pregnancy test.
8. Patients who have received neoadjuvant endocrine therapy are eligible for enrollment as long as they are enrolled within 6 months of initial histologic diagnosis and have completed no more than 2 months of neoadjuvant endocrine therapy.
9. Absolute neutrophil count ≥ 1500/µL, platelet ≥ 100000/mm3, hemoglobin ≥ 10g/dL

Exclusion Criteria:

1. Prior treatment with any CDK inhibitor.
2. Inflammatory breast cancer or stage IV breast cancer or bilateral breast cancer.
3. History of anaphylaxis caused by chemical or biologic components similar to dalsily.
4. Patients who have received any drugs or substances with effective CYP3A isoenzyme inhibitors or inducers within 7 days of enrollment.
5. Uncontrolled intercurrent illness that would limit compliance with study requirements.
6. Pregnant women or women of childbearing potential with a negative pregnancy test within 14 days prior to admission.
7. Patients with any history of malignancy are not eligible.
8. Patients who have received endocrine therapy within 5 years prior to the diagnosis of the current malignancy.
Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS

The purpose of this study is to compare the efficacy of CHG regimen (low-dose cytarabine, homoharringtonine with G-CSF priming) to decitabine in the treatment of higher-risk myelodysplastic syndromes(MDS).

Patients with higher-risk myelodysplastic syndrome (MDS) have a survival rate of 0.4 to 1.2 years as well as a high risk of their disease progressing to acute myeloid leukemia (AML). The only treatment with a curative potential is allogeneic stem cell transplantation. However, in the majority of patients, this treatment is not applicable, mainly due to the age of the recipients and comorbid conditions. Low-dose chemotherapy CHG regimen (low-dose cytarabine, homoharringtonine with G-CSF priming)has been used to treat higher-risk MDS in China and achieve high response rate. Hypomethylating agents 5-aza-2'-deoxycytidine (decitabine) is nucleoside analogs that covalently bind to the DNA methyltransferases, irreversibly inhibiting their function, leading to the progressive loss of methylation and reversal of gene silencing. The purpose of this study is to compare the efficacy and safety of CHG regimen to Decitabine in higher-risk MDS.

Eligibility Criteria:
Inclusion Criteria:

* Age rang from 16 to 80 years;
* diagnosis of higher-risk MDS (with≥ 5% blast in bone marrow);
* a performance status of 0-3 according to the Eastern Cooperative Oncology Group (ECOG);
* no evidence of severe concurrent cardiac, pulmonary, neurologic, or metabolic diseases;
* adequate hepatic (serum bilirubin level \<2×upper normal limit) and renal (serum creatinine \<2×upper normal limit) function tests.

Exclusion Criteria:

* Female with pregnancy;
* a performance of 4-5 according to ECOG score;
* HIV positive;
* uncontrolled severe fungal infection or tuberculosis;
* with other progressive malignant diseases.
Effect of The Foot Care Protocol Applied to Elderly People

The study was carried out randomized-controlled experimental research to determine the foot health status and factors affecting it among elderly individuals, to develop a protective and developmental protocol for foot health of elderly individuals and to determine the effect of this protocol on foot health problems, foot care knowledge levels and foot care behaviors.

Data for the foot health status and factors affecting it among elderly individuals were collected from 28 April 2017 to 5 February 2018. The population of the study comprised 132 elderly individuals living in Nursing Home linked to the Ministry of Family and Social Policies in Ordu Central County. In the research, 118 individuals in the nursing home were reached, the research began with 65 elderly individuals abiding by the inclusion criteria randomized into experimental and control groups and was completed with 57 individuals (experiment: 28, control: 29). Data were collected using the standardized mini mental test, elderly descriptive form, foot examination form, foot care knowledge level form, foot care behavior scale, falling form.. Ethics committee permission, organization permission and written informed consent from individuals were obtained. Five interviews were performed with elderly individuals in the experimental group, while only two interviews were held with elderly individuals in the control group to apply the data collection tools.

Eligibility Criteria:
Inclusion Criteria:

Living in nursing home during the research process, Not dependent on bed, Self-sufficient, No communication problem, Elderly people have good cognitive functions ,(According to the revised mini mental test) Elderly people with any foot problem (dermatological, orthopaedic, circulation, sensory problems, problems related to the feet, self-care problems),

Exclusion Criteria:

Elderly people who are diagnosed with Diabetes Mellitus
Efficacy and Safety of Everolimus With Enteric-Coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion-free Regimen Compared to Standard Therapy in de Novo Renal Transplant Patients

The purpose of this study is to assess whether a calcineurin inhibitor (CNI)-free regimen with enteric-coated mycophenolate sodium (EC-MPS) and everolimus is as safe and well-tolerated as the standard regimen containing enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion, but results in better renal function.


Eligibility Criteria:
Inclusion Criteria :

The following inclusion criteria had to be present at BL 1 (Screening visit prior to transplantation):

1. Males or females, aged 18 - 65 years
2. Recipients of de novo cadaveric, living unrelated or living related kidney transplants
3. Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at BL 1, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility
4. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained

   Of all patients included into the study at BL 1 (prior to transplantation), those who continued into the randomized study period had to meet the following condition at BL 2, prior to randomization:
5. Patients had to be on an immunosuppressive regimen with EC-MPS (target dose; 1440 mg/day, if tolerated; minimal dose: 720 mg/day), cyclosporine and corticosteroids
6. Patients with an actual serum creatinine =\< 3.0 mg/dl

Exclusion Criteria:

The following exclusion criteria must not be present at BL 1 (Screening visit prior to transplantation):

1. More than one previous renal transplantation
2. Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
3. Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
4. Patients who are recipients of A-B-O incompatible transplants
5. Patients with a historical or current peak PRA of \> 25%
6. Patients with already existing antibodies against the HLA-type of the receiving transplant
7. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception

   Of all patients included into the study at BL 1 (prior to transplantation), those who met one or more of the following criteria at BL 2, prior to randomization, should not continue into the randomized study period:
8. Graft loss or death
9. Changes to the immunosuppressive regimen prior to randomization due to immunologic reasons
10. Patients who suffered from severe rejection (\>= BANFF II acute rejection), recurrent acute rejection, or steroid resistant acute rejection
11. Proteinuria \> 1g/day

Other protocol-defined exclusion criteria may apply.
Effects of Walking Apnea At High Lung Volume on Hypoalgesia

The aim of this randomized controlled study is to explore the hypoalgesic response of a 6 minutes of intermittent walking apneas training session at high lung volume in healthy subjects; also, as secondary objectives, to analyze the cardiovascular and respiratory response produced during the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic subjects aged between 18 and 64 years.

Exclusion Criteria:

* Cardiovascular, respiratory, metabolic, neurological or osteomuscular signs or pathologies.

  * History of epilepsy.
  * Pregnant
  * Pharmacological treatment.
  * Participants who present any type of pain on the day of the measurements or who have frequently suffered pain during the previous 4 weeks.
Safety and Efficacy Study of IMM 124-E (Bovine Colostrum) for Patients With Nonalcoholic Steatohepatitis

This is a multi-center, randomized, placebo-controlled, double-blind, dose-selection, multiple dose administration study comprising three groups, with up to 40 patients in each active treatment and placebo group. Patients with biopsy proven nonalcoholic steatohepatitis (NASH) and elevated liver enzymes will be randomized to undergo a liver MRI scan and to receive Imm 124-E or placebo for 24 weeks. During this period, patients will be followed for clinical and laboratory effects. At the end of 24 weeks of treatment, patients will undergo a second liver MRI scan. Patients will be followed for an additional 4 weeks for safety after completion of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Men and women age 18 to 75 years (inclusive)
* Subjects with biopsy proven NASH (NAS ≥ 4) within one year prior to screening
* Elevated liver enzymes at screening and at least once within past 6 months (ALT \> 30 women, ALT \> 40 men)
* Normal or only slightly impaired synthetic liver function (serum albumin \>3.5gm%, INR 0.8-1.5)
* BMI 18 to 40 (inclusive)
* Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study
* Women of child bearing potential must be using adequate contraception

Exclusion Criteria:

* Cow milk allergy or lactose intolerance
* Excessive alcohol use (Women \> 20 grams/day, Men \> 40 grams/day).
* Current treatment with Insulin or Incretins
* Decompensated liver disease
* Other or concomitant cause of liver disease (viral hepatitis, autoimmune liver disease, metabolic liver disease, vascular liver disease)
* Subjects who known to be HIV positive
* Subjects who have undergone surgery within the last 3 months
* Subjects who have had a prior gastrointestinal surgery
* Subjects who have a history of Inflammatory Bowel Disease
* Subjects who are receiving an elemental diet or parenteral nutrition
* Subjects with an infectious, immune-mediated or active malignant disease (during the last 3 months)
* Subjects with known clinically significant systemic disease
* Subjects treated with other anti-NASH therapy(s) - thiazolidinediones, vitamin E, SAM-e, betaine, milk thistle, gemfibrozil, anti-TNF therapies and probiotics) - within 3 months of the liver biopsy
* Subjects who have been treated with any type of immune modulatory drug, including systemic steroids or NSAIDs, within the last 3 months
* Subjects who have received either Immuron, 6-MP, Methotrexate, Cyclosporine, anti-TNF alpha therapies (Infliximab, Adalimumab, Etanercept) or anti-integrin therapies (namixilab) within the past 12 months
* Known history of drug or alcohol abuse, including positive urinary drugs of abuse screen at the screening visit
* Subjects who are pregnant as confirmed on screening test
* Any acute medical situation (e.g. acute infection) within 48 hours of study start that is considered of significance by the Principal Investigator