cyrilzakka/clinical-trials huggingface dataset:
A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes that have already been treated with basal insulin.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with basal insulin and up to 3 of the following oral antihyperglycemic medication (OAM):

  * dipeptidyl peptidase-4 (DPP-4) inhibitors
  * sodium-glucose cotransporter (SGLT-2) inhibitors
  * biguanides
  * alpha-glucosidase inhibitors
  * sulfonlyureas
* HbA1c value of 6.5% to 10%, inclusive
* Body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m2), inclusive

Exclusion Criteria:

* Type 1 diabetes mellitus or latent autoimmune diabetes
* Any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
* Any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
* Acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
* Estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73 m2
* Active or untreated malignancy
* Chronic (\>14 days) systemic glucocorticoid therapy
Study of Focal Cryoablation in Low-Risk Prostate Cancer

The purpose of this study is to find out if men, with low-risk prostate, can have the small amount of cancer within their prostate removed by freezing, called Focal Cryoablation or Cryotherapy.


Eligibility Criteria:
A two-step consenting process will be in place for all patients being enrolled to this study. The two-step method is necessary because all patients being enrolled will need to have a repeat transrectal biopsy after meeting the initial study requirements. The two step consent process would enroll patients considering focal cryotherapy into the initial part of the study (QOL assessment at baseline, PCA3 test, and repeat biopsy); those deemed eligible after the re-staging biopsy would be consented to participate in the remainder of the study (focal cryotherapy, QOL studies, repeat biopsy at 6 months for efficacy, PCA3 test).

First Step Enrollment

Inclusion Criteria:

* Men ≥ 21 years of age with a life expectancy estimated to be \> 10-years.
* Diagnosis of adenocarcinoma of the prostate and confirmed by MSKCC review
* No prior treatment for prostate cancer
* ECOG performance status of 0 or 1
* Prostate cancer clinical stage T1c-T2a
* PSA \< 10ng/mL (this will be the PSA level prompting the prostate biopsy)
* Prostate Size \<60 cc on transrectal ultrasound
* Exclusion Criteria:
* Medically unfit for anesthesia
* Histology other than adenocarcinoma
* Men who have received any hormonal manipulation (antiandrogens; LHRH agonists) within the previous 6 months
* Men who are currently receiving anticoagulant drugs (e.g.: Coumadin, warfarin)

Second Step Enrollment

Inclusion Criteria:

* Repeat transrectal prostate biopsy that must meet the following parameters:
* Minimum of 12 biopsy cores
* No Biopsy Gleason grade 4 or 5
* Unilateral cancer (only right-sided or left-sided, not bilateral)
* No more than 50% cancer in any one biopsy core
* No more than 25% of cores containing cancer

Exclusion Criteria:

* Medically unfit for anesthesia
* Histology other than adenocarcinoma
* Men who have received any hormonal manipulation (antiandrogens; LHRH agonists) within the previous 6 months
* Men who are currently receiving anticoagulant drugs (e.g.: coumadin, warfarin)
EFFECT SGLT2 INHIBITORS ON CONTRAST MEDIUM INDUCED ACUTE KIDNEY INJURY

Chronic kidney disease and type 2 diabetes mellitus patients are with in high-risk patients in coronary arterial diseases and increasing number of coronary angiography and coronary interventional procedures have been performed in these population. As well as the risk factors have been identified by many studies preventive measures are lacking.

In our study we found that SGLT2 inhibitors are beneficial in terms of reducing contrast media induced acute kidney injury in both diabetic and CKD patients.This is one of the leading studies in the literature pointing that SGLT2 inhibitors may have a potentially beneficial role in reducing or preventing the development of PC-AKI.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent coronary artery imaging or percutaneous coronary intervention procedures using contrast media
* Patient ages were between 18 and 75 years
* Estimated glomerular filtration rates (eGFRs) between 25 and 115

Exclusion Criteria:

* Patients with acute myocardial infarction, acute renal injury, history of kidney transplantation, severe heart failure (HF, New York Heart Association IV), malignancy, also patients who received other PC-AKI preventive medications like as N-acetylcysteine, sodium bicarbonate, or incomplete medical records were excluded from the analyses.
Down Syndrome and Continuous Positive Pressure Therapy

The purpose of this study is to evaluate the efficacy and tolerability of Continuous Positive Pressure for SAOS in Down Syndrome patients.


Eligibility Criteria:
Inclusion Criteria:

* Down Syndrome patients with an Obstructive Sleep Apnea Syndrome
* more than 18 years old

Exclusion Criteria:

* predictable non-compliance of device
* non-compensated cardiopathy
* non-stable thyroxin treatment
* non-stable diabetes
Thrombosomes® in Acute Thoracic Aortic Dissections

The hypothesis is that administration of Thrombosomes® (TBX®) as hemostatic support when terminating the cardiopulmonary bypass (CPB) in patients undergoing emergency surgery for acute thoracic aortic dissection (aTAD) is safe and least as effective when compared to standard Platelet Concentrates (stPC).

The study is designed as an exploratory phase 2a, single-center randomized, controlled pilot investigator-initiated trial of administration of Thrombosomes® (TBX®) versus standard platelet concentrates (stPC) in 20 aTAD patients per arm. The patients will be enrolled in the study over a period of 15 months.

TBX® is a novel, human platelet (thrombocyte) derived lyophilized (freeze dried) hemostatic blood product for treatment of bleeding due to thrombocytopenia, dysfunctional platelet disorders or platelet consumption.

The patients will be randomized to administration of either TBX®, or stPC, as part of the Massive Transfusion Protocol (MTP) at the time of termination of the cardiopulmonary bypass (CPB) in addition to standard goal-directed hemostatic optimization based on results from thrombelastography (TEG).

Eligibility Criteria:
Inclusion Criteria:

* Patient eligible for emergency surgery on cardiopulmonary bypass pump for acute thoracic aortic dissections
* Age ≥ 18 years

Exclusion Criteria:

* Documented refusal of blood transfusion
* Aortic dissection due to trauma
* Withdrawal from active therapy
* Known hypersensitivity to TBX: the active substance, any of the excipients
* Pregnancy (non-pregnancy confirmed by patient being postmenopausal (women \>55 years of age) or having a negative urine-hCG).
What is the Optimal Follow-up for Patients With Systemic Sclerosis?

Systemic sclerosis (SSc) is a complex multisystem rheumatic autoimmune disease. Currently, evidence based guidelines for frequency and intensity of follow-up of SSc patients are not available. Based on expert consensus annual extensive evaluation is recommended. To provide comprehensive multidisciplinary care integrated with evaluation of organ involvement and as such, reducing health care utilization while improving the quality of care for the patient, the "Leiden Combined Care in SSc (CCISS) pathway" was started in 2009. Data collected on disease progression in the patients that participate in this care pathway show that 50% of the patients have relatively mild disease, without any disease progression over time. Therefore there is a need for tailor made care in SSc patients in accordance to disease activity. To enable this, a prediction model was developed that can identify patients with low risk for disease progression.

Objectives: To evaluate in SSc patients with low risk for disease progression 1) whether assessment in an outpatient clinic setting is an acceptable alternative for evaluation in the Care Pathway. Outcome parameters we will evaluate include 1) health care utilization, 2) patients' perception of the disease and delivery of care, 3) health-related quality of life and 4) disease progression. Health care utilization as primary outcome is defined as number of contacts with heath care providers during 12 months.

Study population: Patients with a clinical diagnosis of SSc that participated in the Combined Care in Systemic Sclerosis cohort from Leiden University Medical Center (LUMC), or in the comparable care pathway of the Haga hospital and Haaglanden Medical Center (HMC), and that have had at least two care pathway evaluations are eligible to participate in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Participation in the prospective Haga, HMC or LUMC cohort
2. Clinical diagnosis of SSc
3. Age of ≥18 years
4. \>= two evaluations in the Care Pathway
5. Low or intermediate risk for disease progression according to the prediction model
6. Written informed consent

Exclusion Criteria:

1. Patients with SSc who are part of ongoing (randomized) trials
2. Patients who have had an autologous stem cell transplantation in the past five years
3. Patients with SSc who were categorized as high risk for disease progression according to the prediction model.
Functional Food Application of Okara Protein Hydrolysate (OPH)- for Anti-exercise-fatigue

The aim of this study is to investigate the anti-exercise-fatigue effects of okara protein hydrolysate (OPH) in men

Each subject must undergo a cardiopulmonary capacity test to assess the maximum oxygen uptake 1 week before the intervention (day 1), and then eat the test food for 4 weeks (day 8 to day 35). Before and after the intervention (the 8th and 35th day), posture measurement, diet questionnaire survey and endurance exercise ability test were carried out. The trial period was 35 days. The subjects will take blood samples before, during, after, and 30 minutes and 60 minutes after the end of the two endurance exercise tests. During the whole period of participating in the program, blood will be collected 10 times, each with a blood volume of 15 mL. Gas is collected during the period and within 1 hour after exercise. Gas is collected every 15 minutes and 1 minute at a time. Analyze his exercise time, oxygen intake and blood biochemical value.

Eligibility Criteria:
Inclusion Criteria:

* The subject is a male and aged 20-40.
* The subject has a usual exercise habit (exercising 2 times or more per week) and did not participate in professional sports competitions or professional sports training during the study period.
* No smoking or drinking habits.
* No food allergies and the liver function is normal.
* No cardiovascular diseases or other chronic diseases, and no serious illnesses requiring hospitalization during the study period.
* The subject can understand the test process described in the consent form and the possible potential risks and benefits, and can sign the consent form.
* The subject can accept dietary control during the trial period.

Exclusion Criteria:

* Those who have taken nutritional supplements containing branched-chain amino acids.
* Those who cannot complete the endurance exercise ability test.
* Those who are diagnosed with kidney disease, heart disease, or cancer and are still under active treatment.
* Have used other drugs, whose pharmacological effects may affect fatigue.
* Subjects who have systemic infections and require systemic antibiotics.
Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH)

The primary objective of this study is to evaluate the safety and tolerability of study drug(s) in participants with nonalcoholic steatohepatitis (NASH).


Eligibility Criteria:
Key Inclusion Criteria:

* Historical liver biopsy consistent with NASH with stage 2-3 fibrosis according to NASH Clinical Research Network (CRN) classification OR clinical diagnosis of nonalcoholic fatty liver disease and screening FibroTest, magnetic resonance imaging - proton density fat fraction (MRI-PDFF), and FibroScan
* Screening laboratory parameters, as determined by central laboratory:

  * Alanine aminotransferase (ALT) ≤ 5 x upper limit of the normal range (ULN)
  * Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as calculated by the Modification of Diet in Renal Disease (MDRD) study equation
  * HbA1c ≤ 9.5%
  * International normalized ratio (INR) ≤ 1.2, unless due to therapeutic anti-coagulation therapy
  * Platelet count ≥ 100,000/μL
  * Total bilirubin \< 1.3 x ULN unless alternate etiology such as Gilbert's syndrome present
  * Calcitonin ≤ 100 ng/L
* Body Mass Index (BMI) \> 23 kg/m\^2 and body weight of \> 60 kg

Key Exclusion Criteria:

* Any historical liver biopsy consistent with cirrhosis
* Any history of decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding
* Other causes of liver disease, including but not limited to: alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders (eg, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency requiring treatment
* History of liver transplantation
* History of hepatocellular carcinoma
* History of pancreatitis (acute or chronic)
* Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
* Treatment with glucagon-like peptide-1 receptor agonists (GLP-1 RA) in the period from 90 days prior to the date of the Screening Visit
* Individuals on antidiabetic medications must be on a stable dose for at least 90 days prior to the date of the Screening Visit and in the period between the date of the Screening Visit and Enrollment (Day -14)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Dexamethasone for Treatment of Radiation-related Fatigue in Patients Receiving RT for Head-neck and Lung Cancer

This study will look at how dexamethasone and placebo influence radiation fatigue, quality of life and number of treatment days missed during radiation therapy or radiation therapy and chemotherapy for cancer.

Subjects will randomly receive either dexamethasone or placebo and begin the study medication during the midpoint of their radiation treatment. Study medication will be taken for 14 straight days then stopped. Fatigue and quality of life will be measured weekly with short patient completed surveys. The number of breaks taken during radiation treatment will also be tracked. For safety, blood sugar levels will be checked with finger stick blood draws because dexamethasone is known to cause these levels to increase. Study participation will be approximately 3 months.

Eligibility Criteria:
Inclusion Criteria:

* confirmation of head \& neck cancer (stage I-IV) or non-small cell lung cancer (stage II \& III)
* Undergoing treatment with either radiation alone or in combination with chemotherapy
* Normal cognition and willingness to complete fatigue and quality of life forms, patient observation form, and pill diary

Exclusion Criteria:

* Hypersensitivity to dexamethasone or corticosteroids or Equal sugar substitute
* Corticosteroid within the past 30 days prior to study enrollment for greater than one week duration
* Planned Stereotactic Body Radiation Therapy (SBRT)
* Active psychosis
* Current pregnancy
* Active peptic ulcer disease or evidence of gastrointestinal bleed
* Current active tuberculosis or systemic fungal infection
* Previous diagnosis of diabetes mellitus
* Acute febrile illness
* Known human immunodeficiency virus or acquired immunodeficiency syndrome
* Major surgery within two weeks of study enrollment of which the patient has not recovered
* Psychostimulant use in the past 30 days prior to registration
* History of phenylketonuria (PKU)
A Study To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-03864086 In Healthy Male Subjects

The purpose of this study is to determine the safety and tolerability of PF-03864086 in healthy male human volunteers. Determine the pharmacokinetics (calculations of the rate of elimination of PF-03864086 from the body once the compound is ingested).


Eligibility Criteria:
Inclusion Criteria:

* healthy male volunteers
* no drug history
* no other medication for 28 pre-dose

Exclusion Criteria:

* age below 21 years
* age above 55 years
Laparoscopic Single-site Surgery Versus Conventional Entry in Ovarian Cystectomy

The aim of this work is to evaluate the postoperative consequences of laparoendoscopic single site surgery relative to conventional laparoscopy in presumed benign ovarian cyst.

The hypothesis is that single incision technique might offer advantages over the standard multi-port laparoscopy as potentially leading to less postoperative pain and improved cosmoses from a relatively hidden umbilical scar, as well as risk reduction of postoperative wound infection, hernia formation and elimination of multiple trocar site closure


Eligibility Criteria:
Inclusion Criteria:

* The patients are aged 18 to 45 years with BMI \< 35 kg/m2 and that they exhibit a surgical indication for a presumed benign ovarian pathology (PBOP) according to RCOG Guideline no. 62. 2011:

  * simple ovarian cysts \>7cm and \<15cm.
  * Persistent simple cyst for more than 3 months.
  * Symptomatic patients with complicated cyst (e.g. hemorrhagic cyst, torsion, etc)

Exclusion Criteria:

* • Previous midline laparotomies as suspected massive adhesions affecting intraoperative maneuvers and time.

  * Chronic pelvic pain, endometriosis or pelvic inflammatory diseases will be excluded to avoid pelvic adhesions and bias in the quantification of postoperative pain.
  * Do not possess a native umbilicus giving difficult access to single port.
  * The 'risk of malignancy index' (RMI) should be used to exclude those women at greater risk of malignancy. Using an RMI cut-off of 200, a sensitivity of 70% and specificity of 90% can be achieved. if features suggestive of malignancy are encountered, a gynecological oncologist should be consulted regarding further evaluation and staging.
  * Benign teratomas for the difficulty of extraction after removal that affects the intraoperative maneuvers and time.
  * Contraindication to any laparoscopy like any medical condition worsened by pneumoperitoneum or the Trendelenburg position.
  * Contraindication to general anesthesia as all laparoscopic procedures are done under GA.
  * Contraindication to non-steroidal anti-inflammatories, paracetamol, or tramadol.
Molecular Detection of Antibiotic Resistance and H Pylori Eradication

H pylori eradication failure with recommended triple therapy is mainly related to antibiotic resistance. However,IN VITRO culture of H pylori is uneasy and is not performed in routine practice. A molecular test of antibiotic resistance easy to perform is now available. The aim of the study was to compare eradication rates obtained with the standard treatment and with a treatment guided by the results of the molecular detection of antibiotic resistance.

At the present time, H pylori infection is treated with a standard triple therapy. Treatment of naïve patients with triple therapy ( PPI+amoxicillin+clarithromycin for 7 days) markedly decreased last years to reach 70% due to a clarithromycin resistance rate about 20% in France. In case of failure, the recommended second line treatment (PPI+amoxicillin+metronidazole for 14 days) gives a success rate of 60%. However, as culture is uneasy and is only possible in specialised labs sensitivity to antibiotics is not currently studied before treatment.

The aim of the study was to evaluate clinical and medico-economic benefit of the molecular detection of antibiotic resistance in order to guide the treatment.

The test is performed after DNA extraction from biopsy specimens taken at gastroscopy allowing rapid detection of H pylori and clarithromycin or quinolone resistance.

Patients with bacteriologically proven H pylori infection will be randomly allocated to either empirical usual treatment with PPI , amoxicillin 1g, clarithromycin 500 mg X 2 /day for 7 days in naïve patients and PPI, amoxicillin 1g,metronidazole 500 mg X 2 /day for 14 days in patients who failed a first line treatment , or to treatment guided by the molecular test: PPI , amoxicillin 1g, clarithromycin 500 mg X 2 /day for 7 days in case of sensitivity to clarithromycin.In case of resistance to clarithromycin, quinolone should be given and in case of resistance to quinolone clarithromycin should be given. In case of resistance to both antibiotics metronidazole should be given.

Eradication will be assessed by performing 4 weeks after the completion of treatment with Urea Breath Test.

Eligibility Criteria:
Inclusion Criteria:

* H pylori infection bacteriologically confirmed
* Age \> 18 years
* Naïve patient or one failure of the first line recommended treatment
* Patient referred to one out of the centres participating in the study

Exclusion Criteria:

* H pylori positive patient with at least failure of two lies of treatment
* patients with previous adverse event with PPI, amoxicillin, clarithromycin, levofloxacin or metronidazole
* PPI or antibiotic treatment in progressor stopped for less than 4 weeks
* patient with other severe sickness