cyrilzakka/clinical-trials huggingface dataset:
Prevalence and Topography of Adenomas in 40-49 Year Old Patients With a Family History of Colon Cancer

Conflicting guideline recommendations for screening colonoscopy result due to scant data upon which to develop appropriate recommendations. No previous study has compared the prevalence of advanced adenomas or adenomas (any size) among 40-49 year old individuals with a first degree relative (FDR) with colorectal cancer (CRC) versus 40-49 year old average risk individuals with no family history of CRC. The purpose of this study is to determine the prevalence of colon adenomas in 40-49 year old individuals and identify risk factors associated with the presence of advanced adenomas. This data will provide evidence to determine appropriate colon cancer screening guidelines in 40-49 year old persons with a family history of colon polyps or colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* 40-49 year old asymptomatic men and women referred for colorectal cancer screening with a family history of CRC in a first degree relative;
* 40-49 year old asymptomatic men and women referred for colorectal cancer screening with a family history of polyps in a first degree relative;
* 40-49 year old men and women without a family history of CRC or polyps in a first degree relative who are referred for colonoscopy to evaluate scant hematochezia characterized as red blood on toilet tissue after wiping or small droplets of blood on stool or in toilet water after evacuating stool, abdominal discomfort or altered bowel habits characterized as constipation or diarrhea.

Exclusion Criteria:

* Personal history of iron deficiency anemia within six months of referral;
* Personal history of iron deficiency without anemia within six months of referral;
* Personal history of (+) FOBT within one year of referral;
* Personal history of previous colonoscopy or barium enema within the past 10 years;
* Personal history of previous flexible sigmoidoscopy in the past 5 years;
* Personal history of adenoma, colorectal cancer, inflammatory bowel disease, HNPCC, or familial adenomatous polyposis (FAP);
* Unintentional weight loss \> 10 lbs within the previous six months;
* Individuals with family history of CRC AND scant hematochezia;
* Inability to speak and read English.
Open-label Study to Investigate the Safety, Tolerability, PK, and Pharmacodynamics of the AKT Inhibitor GSK690693

This study is a first time in human, Phase I, open-label study to determine recommended doses and schedules, based on maximum tolerated doses and biologically active doses, for the AKT inhibitor GSK690693.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of solid tumor malignancy or lymphoma that is not responsive to standard therapies or for which there is no approved therapy
* Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.

Exclusion Criteria:

* Prior anti-cancer therapy within the prior 28 days.
* History of diabetes.
* Coronary artery disease/myocardial infarction, acute coronary syndromes within the past 6 months.
* Use of theophylline and warfarin within 14 days prior to the first dose of study drug.
* Current use of oral corticosteroids (note: Inhaled corticosteroids are permitted.)
* Participation in an investigational study within the prior 28 days.
* Pregnant or breast-feeding.
An Expanded Access Protocol for Apalutamide Treatment of Participants With Non-Metastatic Castration-Resistant Prostate Cancer

The purpose of this study is to collect additional safety data until apalutamide is commercially available for participants with non-metastatic castrate-resistant prostate cancer (NM-CRPC).


Eligibility Criteria:
Inclusion Criteria:

* Participants with confirmed prostate cancer, with evidence of castration resistance, with a rising prostate-specific antigen (PSA) while on androgen deprivation therapy (ADT), and for whom the treating physician believes additional therapy is indicated in the non-metastatic castrate-resistant prostate cancer (NM-CRPC) setting

  a) Willingness to continue gonadotropin releasing hormone analog (GnRHa) throughout study if the participant is medically castrated
* Must sign an informed consent form (ICF) (or the participant's legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
* To avoid risk of drug exposure through the ejaculate (even participants with vasectomies), participants must use a condom during sexual activity while on study drug and for 3 months following the last dose of study drug. Donation of sperm is not allowed while on study drug and for 3 months following the last dose of study drug
* Willingness and ability to comply with prohibitions and restrictions specified in this protocol, scheduled visits, treatment plans, laboratory, and other study procedures, including ability to swallow study drug tablets

Exclusion Criteria:

* Previously enrolled in another apalutamide study or eligible for enrollment in another ongoing clinical study of apalutamide
* Enrolled in another interventional clinical study of anti-neoplastic agents
* Ongoing grade greater than (\>) 1 acute toxicity due to prior therapy or surgical procedure
* Concurrent therapy with medications known to lower the seizure threshold must have been discontinued or substituted at least 4 weeks prior to study entry
* Current or prior treatment with anti-epileptic medications for the treatment of seizures. History of seizure or condition that may predispose to seizure (including, but not limited to prior cerebrovascular accident, transient ischemic attack, or loss of consciousness within 1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as a schwannoma or meningioma that is causing edema or mass effect)
Study of Abdominal Drainage in LCBDE+PC

Common bile duct stones in clinical manifestations of biliary colic, obstructive jaundice, cholangitis, pancreatitis and other symptoms. At present, thanks to the rapid development of minimally invasive surgery and the concept of ERAS, laparoscopic common bile duct incision and primary suture has been gradually used as a routine surgical approach in clinical application. However, whether or not to place the abdominal drainage tube after surgery, so far has not yet reached a consensus. Therefore, this study focuses on the clinical advantages of LCBDE+PC placed abdominal drainage.

On the basis of the analysis of 7 cases were selected by laparoscopic treatment of cholecystolithiasis complicated with choledocholithiasis bile duct suture in patients with a clinical data of our hospital were prospectively divided into peritoneal drainage group of 40 cases, no abdominal drainage group of 40 cases, compared two groups of operation time, hospitalization time and cost, operation cost, operation bleeding and postoperative bilirubin recovery, complication and return to hospital again and so on, and to explore the clinical significance of indwelling drainage tube.

Eligibility Criteria:
Inclusion Criteria:

* cholecystocholedocholithiasis or simple choledocholithiasis, no intrahepatic bile duct stones, bile duct diameter greater than 8 mm;
* no acute suppurative cholangitis or severe acute biliary pancreatitis;
* all patients were treated with internal medicine before operation, such as anti inflammation, liver protection, correction of anemia, hypoproteinemia, disturbance of electrolyte and acid-base imbalance;
* there was no obvious stenosis of common bile duct;
* aged from 18 to 80 years;
* BMI\<30 kg / m2;
* American Society of anesthesiologists (ASA) anesthesia risk rating of 1 or 2.

Exclusion Criteria:

* severe anemia or thrombocytopenia in patients with 50\*109/L, PT is greater than 15s and can not correct the coagulation disorders;
* severe heart and lung complications can not tolerate pneumoperitoneum and other laparoscopic surgery contraindications;
* IgG4 associated cholangitis and other immune system diseases;
* there is a serious systemic disease. The patients with the following conditions:

  * there was inflammatory stenosis or Oddi sphincter hyperemia and edema at the lower end of the common bile duct;
  * in acute inflammation in patients with obstructive jaundice, such patients have biliary dilatation, the bile duct wall edema obviously and easily with bile duct opening at the lower end of the inflammatory edema, biliary high pressure, suture of bile duct after prone to bile leakage;
  * the presence of severe cholangitis requiring emergency biliary drainage;
  * it is difficult to get a combination of intrahepatic bile duct stones and choledochoscopy;
  * Mirizzi syndrome type II-IV.
Glycemic Response to Oral Nutrition Supplements

This will be a randomized, cross-over study of two oral nutrition supplements in individuals with Type 2 Diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Age 20-75 yrs
* Type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (Amaryl), glipizide (Glucotrol/Glucotrol XL) and glyburide (DiaBeta, Micronase, Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alpha-glucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
* Hemoglobin A1C less than 9.0%
* Fasting blood glucose less than 180 mg

Exclusion Criteria:

* Allergy to milk protein or any other component of the formula
Mazindol in Children With ADHD : Open-label, Efficacy, Safety and Pharmacokinetic Pilot Trial

This prospective pilot trial will evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) and pharmacodynamic (PD) properties of mazindol.

The most common intervention for Attention Deficit Hyperactivity Disorder (ADHD) is pharmacological treatment with methylphenidate (MPH). Effects of MPH on ADHD symptoms in children is extremely well-informed. Mazindol is a psychostimulant and a wake-promoter agent which may have similar actions to MPH in the central nervous system. However, there is no record of the effects, safety, tolerability of Mazindol in children with ADHD. Mazindol (dose 0.5 or 1.0 mg/day) should prove to be useful in the treatment of ADHD symptoms in children. Based on clinical assessments and serum concentrations after oral administration of mazindol to children (6-12 years) with ADHD, this prospective pilot trial will evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) and pharmacodynamic (PD) properties of mazindol.

Eligibility Criteria:
Inclusion Criteria:

* Subjects can be boys or girls
* Subjects must be aged between 6 to 12 years,
* Tanner 1 ou 2
* Subjects with a diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV) criteria
* ADHD-RS score of ≥ 31 as determined by investigator at screening visit.
* Drug free including psychostimulants (10 days before the screening visit)
* Informed Consent Form signed by the subject and both parents
* Healthy on the basis of a physical examination, medical history and the results of blood hematology tests.

Exclusion Criteria:

* Any clinically unstable psychiatric condition including, but not limited to the following: acute mood disorder, bipolar disorder, obsessive-compulsive disorder (OCD), autism or Asperger...
* Sleep Disorders including narcolepsy, hypersomnia (according to International Classification of Sleep Disorders (ICSD) criteria
* Chronic diseases (e.g. asthma...)
* Current eating disorder (e.g. bulimia, anorexia nervosa) or history of an eating disorder during infancy
* Mental retardation (IQ \< 80)
* Hyperthyroidism
* Subjects with history of seizures, glaucoma or familial hypertension
* Heart pathologies
Confocal Endomicroscopy During Endoscopy

The main objective of this study is to determine the role of epithelial cell homeostasis in the pathogenesis of intestinal diseases.

Background: Alterations in intestinal barrier function may play a significant role in the pathogenesis of chronic intestinal diseases such as inflammatory bowel disease (IBD). The intestinal epithelium functions as a barrier to the luminal contents, thereby preventing undesirable solutes, micro-organisms and other luminal antigens from entering the body. Confocal endomicroscopy has recently been shown that increased epithelial cell shedding may contribute to increased intestinal permeability, at least locally. In our study, we want to determine the contribution of epithelial cell shedding to intestinal permeability in vivo in patients with inflammatory bowel disease compared to controls.

Scope:

In inflammatory bowel disease patients and controls (patients undergoing endoscopy for other indications).

Methods:

We will perform confocal endoscopy during the patient's endoscopic procedure.

Procedure:

The patient will receive intravenous fluorescein, followed by confocal imaging of the gastrointestinal tissue. The images are captured on the computer. The proposed study will provide important insights into epithelial cell shedding as a contributor to altered intestinal permeability.


Eligibility Criteria:
Inclusion Criteria for patients includes:

1. Subjects over 18 years of age.
2. Subjects undergoing endoscopic procedures such as gastroscopy, colonoscopy, endoscopic retrograde cholangiopancreatography and endoscopic ultrasound will all be included.

Exclusion Criteria:

1. Under 18 years of age.
2. Cognitively impaired.
3. Residing in institutions (eg. prison, extended care facility)
4. Employees of research(s)' organization
5. In emergency or life-threatening situations
6. Have language barriers (eg. illiterate, not English-speaking, dysphasic) preventing adequate consent process
7. Resides in another country
The Psychometric Properties of the Turkish Version of Interpersonal Communication Questionnaire

In a study conducted by Lewis et al. in 2008, an "interpersonal communication" questionnaire was developed to measure the perceived interpersonal skills of physiotherapy and rehabilitation students regarding patient interaction. It was determined that the questionnaire used especially after the simulated patient training increased the communication of physiotherapy and rehabilitation students after the simulated patient training. However, the questionnaire was not translated into Turkish and its validity and reliability were not investigated. Therefore, in this study, the authors aim to investigate the Turkish validity and reliability of the Interpersonal Communication Questionnaire as the primary purpose. Secondly, to investigate the effect of simulated patient experience on the perceived interpersonal skills of physiotherapy and rehabilitation students regarding patient interaction at the time of the clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Students taking the Measurement and Evaluation II course in Physiotherapy and Rehabilitation

Exclusion Criteria:

* Not volunteering
* Those who are being treated with any psychiatric diagnosis
* Students who fail the course or fail to pass it successfully
Can Differentiated Birth Care Improve the Service?

Prospective evaluation of birth complication in three differently staffed and equipped units in the same hospital.

The study will include approximately 1000 normal births in a county hospital. The mothers are randomly assigned to one of three different maternal wards; one run by midwives, one normally equipped according to national standards for a county hospital and one prepared for complicated births. Endpoints are number of operative births and complications.

Eligibility Criteria:
Inclusion Criteria:

* Healthy mother, normal pregnancy, no prior operations on the uterus, no prior birth complications, no condition with negative effect on pregnancy or birth,one fetus in head position, spontaneously going into birth between week 36,1 and 41,6 of pregnancy,normal cardiotocograph test BMI of 32 or less, smoking no more than 10 cigarettes per day, wants to participate in the study and signs the consent form.

Exclusion Criteria:

* Any condition that has negative effect on the pregnancy or the birth, more than one fetus, all other positions than head position, induction of labor,pre term or post term birth, BMI of more than 32, smoking more than 10 cigarettes per day, does not want to participate.
A Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults

The purpose of the current ZOSTER-101 long-term follow-up (LTFU) study of ZOSTER-049 (NCT02723773) study, an extension of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) primary studies, is to assess the long-term vaccine efficacy (VE) against Herpes Zoster (HZ) (approximately 11-15 years post primary vaccination in ZOSTER-006/022 studies), persistence of immunogenicity and safety of GSK's Herpes Zoster subunit (HZ/su) vaccine in older adults. The persistence of immunogenicity and safety of 1 or 2 additional doses (0, 2-month schedule) of HZ/su vaccine administered to a small group of participants in ZOSTER-049 study (approximately 5 years after the initial vaccination in ZOSTER-006/022 studies) will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Participants and participant's caregiver, who, in the opinion of the investigator, can and are willing to comply with the requirements of the protocol.
* Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study-specific procedure.
* Medically stable participants as established by medical history and clinical examination before entering into the study.
* Participants who completed ZOSTER-049 study (following at least 1 dose of HZ/su in ZOSTER-006/022 studies).

Exclusion Criteria:

Medical conditions

* Any clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.

Prior/Concomitant therapy

* Use of any investigational or non-registered product (drug, vaccine or medical device) for the treatment of HZ or Varicella Zoster Virus (VZV) infection at the time of enrolment or their planned use during the study period.
* Previous vaccination against VZV or HZ and/or planned administration during the study of a VZV or HZ vaccine (including an investigational or non-registered vaccine other than HZ/su administered in studies ZOSTER-006/022 or ZOSTER-049).

Prior/Concurrent clinical study experience

* Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device) for the prevention and/or treatment of HZ or VZV and which may have a possible activity against VZV.
Lomustine and Intermediate Dose Cytarabine in Older Patients With AML

A multicenter randomized trial was performed comparing induction therapy (IC: Idarubicin and Cytarabine, 5+7) to ICL (the same drugs plus lomustine (CCNU), 200mg\\m2 orally at day 1). Patients in complete remission (CR) were then randomized to receive either maintenance therapy or intensification with intermediate-dose cytarabine and idarubicin followed by maintenance therapy.

Induction therapy: Patients were randomized to receive idarubicin plus cytarabine (IC) or the same drugs plus lomustine (ICL), the latter given at the dose of 200 mg/m2 orally at day 1. Patients with persistent leukemia in the bone marrow, defined by at least 20% marrow cellularity with more than 5% blasts on day 14 or at a subsequent time point following initiation of induction therapy, received a second course of induction chemotherapy identical to the initial induction course. Non-responders to the second induction course were taken off the protocol.

Consolidation therapy: After completing induction treatment, patients who were in complete remission after 1 or 2 induction courses received a course of consolidation (IC') therapy with idarubicin and subcutaneous cytarabine. Subsequently, if stable remission persisted, the patients received maintenance therapy or maintenance therapy preceded by a second consolidation (IIC) with intermediate-dose cytarabine. Randomization was performed as soon as CR was achieved.

Maintenance therapy: This was conducted in all patients with persisting CR one month after completing the first (IC) or second (IIC) consolidation and consisted of the following: five courses of combination chemotherapy at 1, 3, 6, 9 and 13 months from the last consolidation, namely cytarabine (subcutaneously) and idarubicin and between these courses for one year: a continuous regimen of methotrexate and 6-mercaptopurine, as alternating 10 day-courses .

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 60 years and older with de novo AML according to FAB criteria
* With normal cardiac function with left ventricular ejection fraction \>= 50%, absence of unstable cardiac arrhythmia or unstable angina.
* Unimpaired renal (creatinin \<180µmol\\L)
* Unimpaired liver (bilirubin \<35µmol\\L) functions.
* Performance status \<3
* Signed and dated informed consent.

Exclusion Criteria:

* Acute promyelocytic leukemia
* Patients with myeloproliferative syndromes prior to diagnosis of AML
* Patients who previously had myelodysplastic syndrome
* Patients pretreated with chemo- or radiotherapy
* Performance status \<2
* Positive serology for HIV
Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Advanced NSCLC

This randomised, controlled, open-label, prospective trial is designed to assess the efficacy and safety of icotinib maintenance therapy after sequential Icotinib plus chemotherapy versus Icotinib maintenance therapy after chemotherapy in stage IIIB/IV non-small cell lung cancer patients with EGFR mutation.


Eligibility Criteria:
Inclusion Criteria:

* Stage IV or IIIB advanced non-small cell lung cancer patients
* Positive EGFR Mutation
* Non-progressive disease after first-line gemcitabine/cisplatin therapy
* Measurable lesion according to RECIST 1.1 with at least one measurable lesion

Exclusion Criteria:

* Previous anti-EGFR (epidermal growth factor receptor) monoclonal antibody or small molecular agent such as gefitinib, erlotinib and so on
* Patients with wild-type EGFR
* Evidence of interstitial lung diseases
* Severe hypersensitivity to icotinib or any of the excipients of this product.
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
Phase 2 Study of NGM282 in Patients With Type 2 Diabetes

The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Type 2 Diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Males or females, between 18 and 70 years of age, inclusive
* BMI range of 24-40 kg/m2, inclusive
* No active coronary artery disease
* Resting heart rate in the range of 40-100 bpm

Exclusion Criteria:

* Diagnosis of Type 1 diabetes
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance