cyrilzakka/clinical-trials huggingface dataset:
Improving Secretion of Insulin in New Onset Diabetes After Renal Transplantation

New onset diabetes after transplantation (NODAT) is a frequent and feared complication after kidney transplantation and leads to an increase in cardiovascular complications as well as in the rate of graft loss. Very little data exist on how patients in which NODAT has been diagnosed should be treated. It is suspected that Cylosporine A (Sandimmun, TM) is less diabetogenic than Tacrolimus (Prograf, TM). Furthermore, it has been described that early initiation of insulin treatment in Diabetes mellitus type 2 can preserve and improve the function of the insulin secreting cells in the pancreas. Therefore, the investigators test the effects of conversion from Tacrolimus to Cyclosporine A in patients with newly diagnosed NODAT who have just started early treatment with insulin. The hypothesis is that patients who are treated with insulin and who are switched to Cyclosporine A have improved glucose metabolism compared to patients who are treated with insulin and who remain on Tacrolimus therapy.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed NODAT defined by pathologic OGTT (2h, 75mg glucose):

glucose ≥ 200mg/dl

* Defect in insulin secretion as judged by OGTT and HOMA B
* Renal transplantation (deceased or living donor) and treatment with the standard immunosuppression at our center, consisting of tacrolimus, mycophenolate mofetil, prednisone triple therapy without any induction
* stable graft function for more than 3 months post transplant
* informed consent of the patient

Exclusion Criteria:

* patients with prior history of type 1 or type 2 diabetes
* time since transplantation more than 20 years
* allergy against long-acting insulin or cyclosporine A
* body mass index (BMI) \> 35
* pregnancy
D-cycloserine Adjunctive Treatment for Posttraumatic Stress Disorder (PTSD) in Adolescents

The purpose of this study is to show whether D-cycloserine in combination with cognitive behavioral therapy (CBT) is more effective than CBT plus placebo to reduce symptoms of posttraumatic stress disorder (PTSD) in 13-18 year-old children.

While most individuals with PTSD treated with cognitive behavioral therapy (CBT) show improvement, they still have some enduring symptoms and functional impairment. Accordingly, there is a need for treatment advances. D-cycloserine (DCS), an antibiotic that has been used for over 50 years, has also been found to have positive effects on cognition and anxiety. DCS was found to enhance learning and memory, and also facilitates extinction of fear reactions. However, DCS only produces an extinction effect when paired with behavioral training, not when simply given alone. Thus, the medication only needs to be given for seven doses in this research and youth do not need to take the medication long term. The research also includes a three-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Certain number of PTSD symptoms plus functional impairment
* Must be able to swallow pills

Exclusion Criteria:

* Serious kidney or liver disease
* Epilepsy
* Bipolar disorder
* Psychosis
HPV Vaccination Among Daughters of Latina Immigrants

The overall goal of this study to promote HPV vaccine uptake among daughters of Latina immigrants between the ages of 9 and 12.

Objective: Implementation and examination of the efficacy of a culturally relevant, community-based HPV vaccination intervention among daughters of Latina immigrants 9-12 years of age in Alabama.

Methods: Group-randomized controlled trial evaluating two interventions: 1) promotion of HPV vaccination and 2) promotion of healthy eating using "place of residence" as the unit of randomization. Between May 2013 and October 2017, forty locations with 317 mother-daughter dyads were enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Latina immigrant
* Resident of selected randomization unit (place of residence)
* 18 years of age and older
* At least one HPV unvaccinated daughter between the ages of 9 and 12

Exclusion Criteria:

-
The Dads in Gear Program: An Innovative Men-centered Approach to Smoking Cessation

The purpose of this feasibility study is to evaluate Dads in Gear, a tailored program to support expectant and new fathers efforts to quit smoking. The 8 week group program integrates peer support and resources to support cessation, physical activity, and knowledge and skills related to fathering.

Using a prospective, non-comparative design, the DIG program is implemented and evaluated in 6 communities in this feasibility study. The program is offered by trained facilitators to fathers who currently smoke and want to quit. The RE-AIM framework is used to guide the evaluation. Open-ended questions in participant surveys, and semi-structured interviews and weekly telephone de-briefs with facilitators provide data for a process evaluation. Estimates of effectiveness include smoking behavior, fathering and physical activity measures at baseline, end of program, and 3-month follow up.

Eligibility Criteria:
Inclusion Criteria:

* Fathers of any age
* Currently smoking and want to quit smoking, or recently quit smoking (within last 2 months)
* Have at least one child under 5 years old or expecting a child (Men do not have to be residing with their children to be eligible)
* Able to attend the group program

Exclusion Criteria:

- Non smokers
A Non-interventional Implementation Study to Evaluate Treatment With Inclisiran (Leqvio®) and Other Lipid Lowering Treatments in a Real-world Setting

This is a multicenter, non-randomized, non-interventional three-cohort study with prospective collection of primary data of treatment with newly initiated oral Lipid lowering treatment on top of a statin (Oral LLT cohort), newly initiated Inclisiran (Inclisiran cohort) and newly initiated Inclisiran on top of lipid apheresis (Apheresis plus Inclisiran cohort) in routine clinical care. All procedures, treatment adaptions and laboratory assessments are part of clinicla routine and conducted independent of this study.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who provide written informed consent to participate in the study
2. Male or female patients ≥ 18 years of age
3. Oral LLT Cohort: Patients with documented ASCVD newly initiated on an oral lipid lowering treatment on top of a statin (e.g. ezetimibe, bempedoic acid, cholestyraimin)
4. Inclisiran Cohort: Patients newly initiated on Inclisiran fulfilling the restricted reimbursement criteria or individual access requirements who are not at LDL-C goal as per their CV risk as recommended in the 2019 EAS/ESC guidelines (Mach et al., 2020). At least 60% of the documented patients must be PCSK9-inhibitor naive
5. Apheresis plus Inclisiran Cohort: Patients with Inclisiran on top of regular weekly or bi-weekly lipoprotein apheresis (LDL-c or LP(a)).

Exclusion Criteria:

1. Oral LLT Cohort: Patients who receive a PCSK9-mAB or other PCSK9-targeted therapy
2. Inclisiran 1 Cohort: current or previous PCSK9-targeted treatment
3. Contraindication for Inclisiran according to the SmPC
4. Patients who have received Inclisiran previously
5. Patients with homozygous FH
6. Any underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results.
7. Simultaneous or planned participation in an interventional research study
A Safety, Efficacy Study of CombiflexOmega Versus SmofKabiven in Patients With Parenteral Nutrition

The purpose of this study is to compare the safety and efficacy of CombiflexOmega in comparison to SmofKabiven in postoperative patients requiring parenteral nutrition.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20 and older
* Patients are expected to require PN for more than 5 days
* Patients who voluntarily signed the consent form

Exclusion Criteria:

* Patients are expected difficult to survive more than 5 days
* Pregnant or breast-feeding women
* BMI \> 30 kg/m2
* Patients with severe blood coagulation disorders
* Patients with congenital amino acid metabolism disorders
* Patients with acute shock
* Patients with uncontrollable diabetes mellitus
* Patients with hemophage syndrome
* Patients with hypopotassemia (K \< 3.0mEq/L)
* Patients having the history of myocardial infarction
* Patients reported the following laboratory value

  * fasting TG \> 250mg/dl, TC \> 300mg/dl
  * ALT/AST ≥ 2×ULN, Bilirubin ≥ 3mg/dl (Exception : patients with periampullary carcinoma including biliary tract or pancreas)
  * Creatinine ≥ 1.5mg/dl
  * Ca \> 11.2mg/dl, Na ≥ 145mEq/L, Mg ≥ 2.1mEq/L, K ≥ 5.5mEq/L
* Patients having hypersensitivity to any peanut-, fish-, soy-, egg protein, or investigational drug
* Patients having the history of drug or alcohol abuse
* General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, cardiac decompensation
* Patients are in unstable conditions
* Patients with difficult peripheral intravenous
* Patients with parenteral nutrition within 7 days prior to start of the trial
* Participation in another clinical study with an investigational drug or an investigational medical device within 28 days prior to start of study
* Patients judged to be unsuitable for this trial by investigators
Trendelenberg Versus Left Lateral Position for Colonoscopy

The purpose of this study is to determine if the trendelenberg (TD) position (position in procedures that involves placing the patient at an angle so that their head is lower than their feet on the procedure bed) in select patients undergoing colonoscopy is superior than the left lateral (LL) position (patient laying on their side, traditionally used for colonoscopies) in terms of decreasing time necessary to pass the colonoscope through the left colon, and decreasing the difficulty of the procedure.

The colonoscopists will be asked to rate their prediction of difficulty of the procedure prior to the colonoscopy and to rate the ease of procedure after the colonoscopy. The clinical experience of the study investigators is that TD positioning is superior to LL positioning in patients with risk factors for having a difficult colonoscopy (thin women; those with diverticulosis- small bulging pouches present in the colon; or prior pelvic surgery).

Patients with risk factors for difficult colonoscopy will be randomized to undergo colonoscopy while positioned in the TD position or the LL position during advancement of the colonoscope through the sigmoid colon. The sigmoid colon is a section of the colon, proximal to the rectum, that is curved. The sigmoid colon is a normal component of GI tract anatomy, although due to it's shape, especially with the risk factors listed previously; can cause challenges to inserting the colonoscope.

Eligibility Criteria:
Inclusion Criteria:

1. Personal history of pelvic surgery
2. Diverticulosis, identified by patient report or review of previous colonoscopy or imaging studies.
3. BMI \< 25.

Exclusion Criteria:

1. Patients who do not meet inclusion criteria.
2. Patients who have undergone colonic resection
3. Patients with glaucoma
4. Patients with uncontrolled acid reflux disease or active nausea/vomiting.
5. Patients who are unwilling or unable to consent.
6. BMI \> 30
Difference Between Central and Peripheral Arterial Blood Oxygen Saturation With Different CPB Strategy

Femoro-femoral cardiopulmonary bypass with retrograde perfusion is needed for totally thoracoscopic cardiac surgery. one of the major complication of retrograde perfusion is organ hypoperfusion.

Arterial blood gas analysis can help to detect hypoperfusion or hypoxia during retrograde perfusion. However,whether the arterial oxygenation status from different parts of the body are the same in the condition of retrograde perfusion have not been studied.

The present study is aimed to determine if there is difference in the arterial oxygenation between peripheral arterial and aortic root during the period of retrograde perfusion.In addition, the impact of artificial ventilation on the difference of arterial oxygenation will also be investigated.

All patients included will be assigned into two different groups according to the surgical approach,one group is named "NP" with normal perfusion,and the other is named "RP" with retrograde perfusion.

For all the patients,we will obtain 0.5ml blood from both peripheral arterial and aortic root for blood gas analysis at some specific time points.

We will focus on the differences of arterial oxygenation between peripheral arterial and aortic root at each group.At the same time,we will analyse the impact of artificial ventilation on it.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* undergoing totally thoracoscopic cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* without informed consent
* pregnancy
Comparing Standard of Care Biopsy System to a Novel Biopsy Needle System by Computational Pathologic Analysis

Prostate biopsy is the definitive examination to establish the diagnosis of prostate cancer, but up to 40% of these biopsies overestimate or underestimate the severity of the disease. A novel biopsy needle system captures substantially more tissue than standard of care needles, but it is important to assess the retrieval of tissue for pathologic analyses. This study will compare quality and quantity of tissue retrieved by both systems. Further, tissue will be analyzed using computational pathology algorithms for atypical small acinar proliferation and Gleason scores in terms of tissue area, tissue length, and tissue tortuosity.

Prostate tissue captured in needle biopsy procedures are used to diagnose prostate cancer, but current biopsy systems (standard of care control device) have been shown to underperform when compared to a new novel needle biopsy system (test device). The objectives of the study are to (1) compare tissue quality between test and control devices; (2) compare diagnostic ambiguity between the two devices; and (3) compare tissue area, length, and tortuosity from the samples with a computational pathology algorithm. Tissue analyses will be completed by pathologists blinded to the biopsy system used.

Eligibility Criteria:
Inclusion Criteria:

* Adult males with PSA density greater than or equal to 0.15
* Lesions are visible under MRI
* PIRADS score is greater than or equal to 3
* Able to and willing to provide consent

Exclusion Criteria:

* Subject has had previous local prostate therapy, focal therapy, brachytherapy, ADT, surgery, or chemotherapy for prostate cancer
* History of dementia, cognitive impairment, or deep vein thrombosis (DVT)
* Is a prisoner currently or has a history of incarceration
* Unable to understand English
* Has metastatic prostate cancer or a tumor stage of T2c, T3, or T4
* Has concurrent malignancies
* Is positive for HIV, HBV, and/or HCV infection
* Has low-performance status
A Prospective Evaluation of the Strattice-LIFT to Treat Anal Fistula

This clinical trial will evaluate the safety and efficacy of the Strattice-LIFT procedure to treat anal fistulas.

The treatment of anal fistulas remains a challenging clinical problem. Fistulotomy is highly effective, but carries a significant risk of postoperative incontinence. A variety of surgical procedures that do not divide the sphincter muscle may be offered to patients, however none of them are as effective as fistulotomy.

The LIFT (ligation of intersphincteric fistula tract) procedure is a newer option for the treatment of transsphincteric fistulas. Initial results have been promising. However, some fistulas recur after the LIFT procedure because the divided ends of the fistula tract recanalize. Insertion of a barrier into the intersphincteric space may prevent this process. Strattice is acellular porcine dermis, will be used for this purpose.

This prospective trial will evaluate the safety and efficacy of the Strattice-LIFT procedure for the treatment of transsphincteric anal fistulas.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 22 years of age or older
2. Subject is willing to comply with study related procedures
3. Subject is not pregnant
4. Subject has a transsphincteric fistula
5. Subject is medically fit to undergo LIFT
6. Subject has a draining seton for a minimum of 6 weeks

Exclusion Criteria:

1. Crohn's disease
2. Pelvic radiation treatment
3. Known or suspected HIV/AIDS
4. Known sensitivity to pork products
5. Abscess or fistula etiology other than cryptoglandular
6. Abdominal malignancies
7. Patients with \<1 year life expectancy
8. History of smoking
9. Known anorectal dysfunction (fecal incontinence)
10. Chronic use of steroids or other agents which may affect wound healing
11. ASA ≥ 2
12. Unable to consent to study
13. Unable to complete 1 year follow up
Observational Pharmacokinetic Study Of GW679769 In Subjects With Renal Impairment

The purpose of the study is to evaluate how subjects with mild or moderate kidney problems process or breakdown the study drug GW679769 in their bodies as compared to healthy subjects.


Eligibility Criteria:
Inclusion criteria:

* Healthy or have mild or moderate renal impairment.
* Females must be of non-childbearing potential(hysterectomy, bilateral oophorectomy, post-menopausal) OR childbearing and must have a negative pregnancy test and meet/comply with one of the following: abstinence, double-barrier contraception, vasectomized partner).
* Be negative for Hepatitis B and C.
* Have negative results on drug, alcohol and HIV tests.
* Have stable renal function.

Exclusion criteria:

* Have a peptic ulcer.
* Abuse drugs or alcohol.
* Are pregnant or lactating.
* Have heart failure.
* Have uncontrolled emesis.
* Have an infection.
* Have taken or received inducers or inhibitors of CYP3A4 or CYP3A5 within 14 days of study start.
* Active peptic ulcer disease.
* Digoxin use.
* Laboratory results that show low iron or pepsinogen levels, AST and CK level \>1,5 ULN, or that show stool is positive for occult blood.
Validation of a New Generation of Orthopedic Brace for Treating Adolescent Idiopathic Scoliosis by Using Growth Modulation

Adolescent Idiopathic Scoliosis affects 3-4% of the Canadian population, of which about 10% will need a brace treatment during pubertal growth spurt. Our team has developed an innovative conception method for brace design by simulating the growth modulation using numerical models. Those models are customized to each patient. In this project, the investigators will evaluate the effectiveness of this platform customized treatment and validate its clinical application.


Eligibility Criteria:
Inclusion Criteria:

* AIS diagnosis
* Risser 0-2
* Primary curve angles 20 degrees - 40 degrees
* If female, either premenarchal or less than 18 months postmenarchal.

Exclusion Criteria:

* Patients with a pre-existing cardiovascular condition
* Patients with a symptom of a neurological disorder
* Patients with any other disorder of the musculoskeletal system affecting the lower limbs
STEMI Versus NSTEMI: Clinical and Angiographic Differences

The purpose of this study is to assess differences in the risk profile and in the coronary angiographic presentation between STEMI and NSTEMI. Moreover possible relationship between myocardial infarction presentation and renal function will be investigated.

Assessment of risk profile. Diabetes mellitus diagnosed when fasting blood glucose (FBG) was \>= 126mg/dL or if patients were taking oral hypoglycaemic drugs or were on insulin treatment. Hypertension defined as blood pressure \>= 140/90 mmHg or history of antihypertensive treatment. Hypercholesterolemia,adjudicated when cholesterol levels were \>= 200 mg/dL or with patients on lipid lowering treatment. Hypertriglyceridemia adjudicated on fasting triglyceride levels\>= 200 mg/dL or triglyceride-lowering therapy . Obesity, defined as BMI \>= 30 kg/m2.

Patients with STEMI, who had not been previously treated with thrombolysis, and those who had been undergone to an unsuccessful thrombolysis, as well as patients with NSTEMI with a TIMI score\> 3 who were immediately referred to the Cat Lab and whenever possible treated with PTCA and stenting of the culprit lesion. The other patients who were referred to Cat Lab within 48 hours from the beginning of chest pain, unless their general conditions did not strongly suggest to delay the procedure after 2 more days.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted in the coronary care unit (CCU) of the Department of Clinical and Experimental Medicine at the Federico 2nd University Hospital;
* Patient with indication to angiographic study even if not immediately;
* Patients referred to CCU with the diagnosis of acute myocardial infraction (AMI), type STEMI, or NSTEMI, based on pre-admission assessment of troponin I (TpI) and myocardial band creatin kinase (CK-MB;
* Diagnosis of NSTEMI/STEMI performed according to standard criteria

Exclusion criteria:

* Patients who could not undergo angiographic study
Efficacy and Safety of Platycodon Grandiflorus Extract(GCWB107) on Decrease of Body Fat

This study was conducted to investigate the effects of daily supplementation of Platycodon grandiflorus extract(GCWB107) on decrease of body fat.

This study was a 12-week, randomized, double-blind, placebo-controlled human trial. 80 subjects were randomly divided into Platycodon grandiflorus extract(GCWB107) group and a placebo group. It is to evaluate the changes in the displayed evaluation items when taking Platycodon grandiflorus extract(GCWB107) extract once a day, in comparison with taking a placebo.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged between 19 and 65 years at the screening
* Participants who were BMI 25\~29.9 kg/m\^2
* Participants who have fully understood the information provided about the study voluntarily decided to participate and agreed to comply with precautions

Exclusion Criteria:

* Participants who decrease 10% more of weight within 3 months period to the screening examination
* Participants taking for products affecting body weight within 4 weeks before the screening examination(i.e., Improvement of body fat Healthy functional food, contraceptive, steroid drug treatment, female hormone drug treatment) (However, participation is possible after a 4-week withdrawal period prior to the first intake day)
* Participants who drink more than 14 units/week of alcohol intake
* Patients with a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry system, musculoskeletal system, inflammatory and hematologic
* Patients with diabetics who are taking oral hypoglycemic agents and insulin (at the screening)
* Participants with a past history of gastrointestinal diseases (e.g., Crohn's disease) or gastrointestinal surgery (but, excluding simple cecal surgery and hernia surgery) that can affect the absorption of products of the human trial
* Participants who have a history of clinically significant hypersensitivity to balloon flower and saponin components
* Participants receiving antipsychotic medication within 2 months prior to the screening examination
* Participants who were doubtful about drug abuse
* Participants who have participated in other clinical trials within 3 months prior to the screening examination
* Participants who have SBP≥180 mmHg and DBP≥110 mmHg
* Menopause women
* Participants who show the following relevant results in a Laboratory test

  * Aspartate Transaminase(AST), Alanine Transaminase(ALT) \> Reference range 3 times upper limit
  * Serum Creatinine \> 2.0 mg/dl
* Women who are pregnant or breastfeeding
* Women who may become pregnant and have not used appropriate contraceptives
* Participants who the principal investigator judged inappropriate for the participant in this study because of a laboratory test result, etc