cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of a High-risk Diabetic Patients Program

The purpose of this study is to determine whether case management for type 2 diabetic patients with target-organ damage improves quality of care compared to usual care.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes mellitus
* Age between 18 and 80 years old
* Target organ damage (either macrovascular or microvascular)
* Patient's acceptance to participate

Exclusion Criteria:

* Moderate to severe dementia
* Life expectancy lower than one year
* Justified negative from primary care physician to intervene the patient.
Convenience and Safety of Assisted Reproductive Technology Procedures Using a Gonal-F Filled by Mass (Fbm) Liquid Formulation Applied by Pen for Ovulation Induction and In-vitro Fertilization

This was a prospective, open-label, non-comparative, Phase IIIb trial to assess the convenience, safety and efficacy of the new Gonal-F fbm \[recombinant follicle stimulating hormone (r-FSH)\] liquid formulation, in common setting for ovulation induction (OI) and also in in-vitro fertilization (IVF).


Eligibility Criteria:
Inclusion Criteria:

* Female subjects aged between 18 and 43 years
* Ambulatory subjects
* Subjects who are willing to get pregnant and are infertile, that justifies ovarian stimulation treatment for mono-/pauci-follicular development (OI or IUI) or multiple follicular development for IVF/Intracytoplasmic Sperm Injection (ICSI) procedures
* Subjects who are able to communicate well with the investigator and to comply with the requirements of the entire study
* Subjects who have given written informed consent, prior to treatment

Exclusion Criteria:

* Subjects with enlarged ovaries or cysts unrelated to polycystic ovaries
* Subjects with extra-uterine pregnancy during the last 3 months
* Subjects with several endometriosis (Grade III \& IV)
* Subjects with history of severe ovarian hyperstimulation syndrome
* Subjects with history of thromboembolic event
* Subjects with malformative uterine pathology that could disturb either implantation or pregnancy processes
* Subjects with premature menopause
* Subjects with gynecological bleeding of unknown origin
* Subjects with ovarian, uterine, or mammary cancer
* Subjects with tumors of the hypothalamus or the pituitary glands
* Subjects with history of serious allergy or atopic asthma disease
* Subjects with known allergic reaction against one of the Follicle Stimulating Hormone (FSH) and ingredients,
* Ongoing pregnant, or breast feeding subjects
* Subjects who have participated in a trial during the last 3 months
Reactions to Reduced Nicotine Cigarettes in Young Adult Low-Frequency Smokers

The purpose of this study is to evaluate reactions to, and choices to self-administer, cigarette smoke with varying nicotine content among low-frequency, non-dependent adolescent/young adult smokers between the ages of 15-25 years.

Participants will undergo three sessions in which their reactions to fixed doses of smoke from investigational cigarettes with three different nicotine contents (15.8 mg/gram of tobacco, 2.5 mg/g, and .4 mg/g) will be assessed. Following the third fixed-dose session, participants will return to the lab to choose one of the cigarettes to self-administer.

Eligibility Criteria:
Inclusion Criteria:

* generally healthy
* between the ages of 15-25
* use nicotine or tobacco products between 1-15 days/month for at least 6 months
* smokes at least 5 cigarettes/month
* no unstable or significant medical or psychiatric conditions
* breath alcohol value=0.000
* able to provide contact information for two individuals who can corroborate smoking status

Exclusion Criteria:

* use of illegal drugs as measured by urine drug screen (excluding THC)
* serious quit attempt in the past 3 months
* plans to quit smoking in the next 2 months
* current use of nicotine replacement therapy or other tobacco cessation products
* inability to attend all required experimental sessions
* blood pressure \>160/100 mmHg
* pregnant, trying to become pregnant, or breastfeeding
A Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval

This is a prospective longitudinal study to assess the impact of repeat Cologuard testing at 3 years in average risk patients.

This is a prospective longitudinal study to assess the impact of repeat Cologuard testing at 3 years in average risk patients. Enrolled subjects will be prescribed Cologuard per approved labeling at baseline. Subjects with positive results will be referred to colonoscopy and study participation completed. Subjects with negative Cologuard results will be seen annually for 3 years. At year 3, subjects will repeat Cologuard, followed by colonoscopy, regardless of the Cologuard test outcome. Subjects who have a colonoscopy at any time during the study will be discontinued following collection of the colonoscopy and associated histopathology results.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has been prescribed Cologuard for colorectal cancer screening
2. Subject is at average risk for development of colorectal cancer
3. Subject is 50 years or older
4. Subject willing and able to sign informed consent.

Exclusion Criteria:

1. Subject had a colonoscopy in the previous 9 years
2. Subject has undergone any double-contrast barium enema, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years.
3. Subject has had a positive fecal occult blood test or FIT within the previous six (6) months.
4. Subject has any condition that in the opinion of the investigator should preclude participation in the study (e.g., subject not eligible for a diagnostic colonoscopy).
5. Subject has a history of colorectal cancer or advanced adenoma.
6. Subject has a history of aerodigestive tract cancer
7. Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease
8. Subject has had overt rectal bleeding, e.g. hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding)
9. Subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer:

   * Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.
   * 2 first-degree relatives who have been diagnosed with colon cancer. (Note: first-degree relatives include parents, siblings and offspring).
   * One first-degree relative with CRC diagnosed before the age of 60.
10. Subject has a family history of:

    * Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP).
    * Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
    * Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis.
Eccentric Exercise in Epicondylitis

There is more and more evidence of the importance of the role of kinesitherapy in the management of epicondylitis, specifically (but not exclusively) of eccentric exercise. Since eccentric kinesitherapy, when applied in a systematic way by a physiotherapist, consumes time and human resources in a significant way, and in the case of such a prevalent pathology, it is frequent that strategies of training the patient are addressed so that this is who perform the exercises after learning them. However, it is not proven that the efficacy and safety of this approach is equivalent to treatment applied by a physiotherapist.

A randomized single-blind controlled trial is conducted that compares both treatment approaches for epicondylitis (eccentric exercises applied directly by a physiotherapist for 10 sessions, and eccentric exercises applied by the patient during the same time) in terms of efficacy against pain, functionality and patient satisfaction, all this within the framework of the public health system.

The main objective of this study is:

To compare the efficacy of an eccentric exercise program applied to patients with epicondylosis by a structured manual program in ten sessions and by an illustrated booklet.

The specific objectives of this study are:

Compare the effectiveness of the above-cited approaches in terms of pain Compare the effectiveness of the above-cited approaches in terms of function Compare the effectiveness of the above-cited approaches in terms of satisfaction

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years old
* Epicondylosis of three or more months of evolution.
* Acceptance of the voluntary participation in the study and signature of the informed consent.

Exclusion Criteria:

* Generalized musculoskeletal pain.
* Rheumatological affections involving of the upper limb.
* Cervicobrachialgia.
* Previous trauma in upper limb.
* Neurological or other pathology that may interfere with the function of the upper limb.
* Being out of work or in litigation due to the pathology of the upper limb.
Effect of Gum Arabic on Gastrointestinal Transit and Permeability

The study aims to determine the effect of gum arabic on gut bacteria and GI function.

To compare the effect of placebo, low-dose prebiotic, or high-dose prebiotic on gut microbiota composition and function, GI transit and permeability, and assess development of symptoms or a change in pre-existing symptoms present, in patients with recent history of clinically diagnosed diverticulitis which has been successfully treated.

Eligibility Criteria:
Inclusion Criteria:

1. Recent diagnosis of diverticulitis (within 24 months) and at least 4 weeks post antibiotic use
2. Age 18-80

Exclusion Criteria:

1. Prior history of gastrointestinal surgeries (except appendectomy and cholecystectomy)
2. Known diagnosis of inflammatory bowel disease (Crohn's or ulcerative colitis), microscopic colitis, celiac disease, or other inflammatory condition other than diverticulitis
3. Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
4. Use of NSAIDs or aspirin within the week prior to Visit 2 and Visit 5 (permeability and transit testing visit since NSAIDs affect intestinal permeability)
5. Use of osmotic laxatives one week prior to Visit 2 and for the duration of the study
6. Use of oral corticosteroids within the previous 6 weeks and for the duration of the study
7. Ingestion of artificial sweeteners such as Splenda™ (sucralose), Nutrasweet™ (aspartame), sorbitol, xylitol, lactulose, or mannitol 2 days before and during the permeability testing days, e.g. foods to be avoided are sugarless gums or mints and diet beverages
8. Antibiotic use within 4 weeks of completion of the initial stool kit and/or Visit 2 testing appointment and for the remainder of the study (they can complete the stool kit and Visit 2 after a 4-week washout period)
9. Bowel preparation for colonoscopy less than one week prior to the completion of the first stool kit and Visit 2 and during the remainder of the study
10. Pregnancy or plan to become pregnant within the study timeframe
11. Vulnerable adults
12. Egg allergy or resistant to ingesting eggs
13. Diagnosis of diabetes
14. Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes
Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease

Aspirin and clopidogrel +/- heparin or thrombolytic co-therapy is well established and effective treatment for unstable cardiac patients. However, the major complication was gastrointestinal bleeding (GIB) due to peptic ulcer. In the prevention of GIB, anti-ulcer drug either H2-receptor antagonist (H2RA) and proton pump inhibitor (PPI) were commonly prescribed. There has been no prospective controlled study to compare the efficacy of these two classes of anti-ulcer drugs.


Eligibility Criteria:
Inclusion Criteria:

* patients admitted for acute coronary syndrome or acute myocardial infarction requiring active treatment with aspirin clopidogrel and (enoxaparin or thrombolytics.)

Exclusion Criteria:

* known active peptic ulcer disease or gastrointestinal within 8 wk
* known iron deficiency anemia with Hb \< 10 gm/dl
* mechanical ventilation
* active cancer, liver cirrhosis, end-stage renal failure
* life expectancy \< 1 yr
* known allergic to aspirin, clopidogrel, enoxaparin famotidine or esomeprazole
* pregnancy, lactation, child-bearing potential in the absence of contraception,
* co-prescription of NSAID, corticosteroid, or warfarin
* non-oral feeding or impaired GI absorption e.g. vomiting
* already on proton pump inhibitor for \> 1 day or another clinical trial drug for ulcer disease
Practice With Simulator Improves Basic ERCP Skills of Surgical Trainees

To test the benefits of ERCP Mechanical Simulator (EMS) practice in improving ERCP cannulation success rate of novice surgical trainees.

Practicing Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures using the EMS provides opportunities for novice endoscopists to learn basic ERCP skills without a patient. In two randomized controlled trials (RCT), coached EMS practice increased selective bile duct cannulation success rate of novice endoscopists. Surgical trainees do not have sufficient endoscopy experience to meet the perceived basic requirement for ERCP training. However, ERCP is done with a side-viewing scope and even experienced GI trainees have difficult initially mastering the basic skill with scope manipulation and cannulation. It is not known whether EMS can provide additional benefit to novice surgical ERCP trainees.

Eligibility Criteria:
Inclusion Criteria:

* No experienced surgical trainees receiving ERCP training

Exclusion Criteria:

* Experienced surgical ERCP trainees or who are not receiving ERCP training
MR-target Biopsy vs. TRUS-biopsy in Men With Suspicious Prostate Cancer

This paired cohort blinded trial aims to assess the detection rate of clinically significant cancer of MRI-targeted biopsy compared to standard 12-core TRUS biopsy in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy. The investigators hypothesize that additional MRI-targeted biopsy will detect more clinically significant cancers than standard TRUS biopsy.

Main objective: To compare MR-target vs. standard 12-cores TRUS-biopsy for the diagnosis of clinically significant prostate cancer.

Before prostate biopsy, all patients be preceded by mpMRI. The mpMRI is read by an experienced radiologist according to the PI-RADS version 2 scoring system. PI-RADS scoring system is used to assign a degree of doubt prostate cancer. Depending on the PI-RADS score, MR targeted biopsy is determined.

1. MR-targeted biopsy using Artemis device fusion of MRI and ultrasound images would be performed. MR targeted biopsy would be performed by radiologist.
2. Next conventional ultrasound-guided 12-core systematic biopsy would be performed by urologist. This portion will be performed without information of the MRI report.

Eligibility Criteria:
Inclusion Criteria:

* 1. Men undergoing a first-time prostate biopsy to rule out cancer
* 2. Serum PSA ≥3ng/mL, ≤20ng/mL
* 3. Age≥50 years, ≤80 years
* 4. Clinical stage ≤T2c
* 5. Patients must be able to provide written informed consent.

Exclusion Criteria:

* 1. Patients has any prior needle biopsy of the prostate
* 2. Patients has a prior history of prostate cancer
* 3. Patients has a prior history of pelvic radiation therapy or androgen deprivation therapy
* 4. Patients has a prior history of BPH operation
* 5. Patient with uncorrectable coagulopathies
* 6. Unable to tolerate a TRUS guided biopsy.
* 7. Patients had 5-alpha reductase inhibitor in the past six months.
* 8. The patient has had a urinary tract infection or acute prostatitis in the last three months.
* 9. Any contraindication to MRI (severe claustrophobia, pacemaker, MRI-incompatible prosthesis, eGFR ≤50mls/min)
Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma

Compare Hepatiis C Virus (HCV) detection between oral squamous cell carcinoma (OSCC) and normal tissues, to determine the possible relationship between HCV and OSCC.

Patient / Population: Paraffin embedded tissue samples of OSCC. Indicator: OSCC patients Control: Normal patients Formalin fixed paraffin embedded specimens from blocks retrieved from the archives of the Oral and Maxillofacial Pathology Department, Faculty of dentistry, Kasr Alini hospital setting from January 2014 till February 2018. All clinical and histopathological data from medical reports, will be reviewed and data will be collected regarding age, sex, tumor location, history of smoking and alcohol consumption, nodal status, tumor recurrences and histological classification of the patients. The specimens will be obtained from 2 groups:-

1. OSCC specimens. Histological diagnosis of H\&E stained sections will be performed according to World health organisation (WHO) guidelines by 2 independent pathologists.
2. Normal oral mucosa specimens (control).

outcome: I) Immunohistochemical detection of Hepatitis C core antigen (Hep C cAg) : sc-58144, santa cruz biotechnology, USA) a mouse monoclonal antibody raised against Hepatitis C virus will be purchased and used for immunohistochemical staining. Staining procedure using an automated system Ventana Benchmark. The four µm thick paraffin embedded tissue sections will be deparaffinized in three changes of xylene then microwaved for antigen retrieval. The slides will be incubated with primary antibody overnight in the humidity chamber at room temperature. Then, the slides will be incubated with secondary antibody. The peroxidase activity will be made visible with diaminobenzidine. Finally, counterstaining will be obtained using Mayer's hematoxylin.

The immunostained sections will be examined using analyzer computer system (Germany).

Eligibility Criteria:
Inclusion Criteria:

1. Presence of sufficient paraffin-embedded tumor material;
2. Presence of oral cavity cancer (including oral tongue, floor of mouth, gingiva, lips, buccal mucosa)
3. Absence of recurrent head and neck cancer
4. Absence of previous oncologic therapy;
5. Histological-proven squamous cell carcinoma.

   -

   Exclusion Criteria:

   subjects with missing information on age or sex will be excluded.

   -
the Effect of Instructional Method on Decision Making

In these single- blind clinical trial 67 primigravida females, gestational aged 34-36 week were selected using multi-stage sampling and assigned into two groups randomly. Decision-making (before, two weeks after and at admission in maternity department) was tested by a researcher -made questionnaire. In experiment group, advantages and disadvantages of normal delivery and cesarean-section delivery were presented by role-playing in three 90-min scenarios. It was also presented in a 90-min lecture. Data were analyzed using SPSS by mean difference test, exact fisher test, independent t-test and paired t-test.


Eligibility Criteria:
Inclusion Criteria:

primipara , single pregnancy , gestational age of 34-36 weeks ,age of 18-35 years old, no history of infertility, no indication for cesarean section, no passing educational course for delivery methods

Exclusion Criteria:

medical condition in pregnant woman, diagnosis of abnormal fetus / no possibility for delivery fetus by sonography, abnormal volume of amniotic fluid or placenta
Changing Chat: Diaper Tips to Improve Language Development

This randomized trial has two sets of diapers-- a normal one and one that has tips for how to talk to and engage your toddler. The investigators are hoping that the intervention improves language development.


Eligibility Criteria:
Inclusion Criteria:

16-18 months of age developmentally normal English speaking

Exclusion Criteria:

-
Co-administration of Low Dose hCG at the Time of GnRH Agonist Trigger or 35 Hours Later for the Prevention of OHSS

This a prospective randomized double blind study involving patients at high risk of OHSS development with peak serum E2 levels \< 4,000 pg/ml comparing the ongoing pregnancy rates in patients who receive adjuvant hCG 1,000 IU at the time of GnRH agonist trigger or adjuvant hCG 1,500 IU 35 hours after GnRH agonist trigger.

Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic complication of controlled ovarian hyperstimulation which may result in significant morbidity and rarely mortality as well as significant financial and psychological distress. GnRH agonist trigger has been shown to be effective in OHSS prevention. However, the adoption of its use has not been widely accepted in view of concerns regarding potential impairment of implantation.

Intensive luteal phase supplementation with estrogen (E2) and progesterone (P) is important due to the strong evidence of abnormal luteal phase serum E2 and P profiles. However, it has been shown that optimal conception rates is not achieved for high risk patients with peak serum E2 \< 4,000 pg/ml despite aggressive steroidal supplementation. It has been proposed that the use of adjuvant low dose hCG at the time of GnRH agonist trigger or 35 hours later will rescue some of the corpora lutea and help improve corpora lutea function and improve pregnancy rates.

The study will evaluate patients at high risk of OHSS development with peak serum E2 \< 4,000 pg/mL to determine whether timing of low dose hCG administration affects ongoing pregnancy rates or risk of OHSS. Markers of corpus luteum function such as serum 17 hydroxy-progesterone and prorenin during the luteal phase and early pregnancy will help elucidate further the effect of adjuvant low dose hCG with GnRH agonist trigger on corpus luteum function.

Eligibility Criteria:
Inclusion Criteria:

* Normal baseline serum follicle stimulating hormone, polycystic ovarian syndrome (PCOS), Polycystic ovarian morphology, Previous high responder or previous OHSS, must have \> 14 follicles of over 11 mm in diameter and with peak serum E2 levels \< 4,000 pg/mL on the day of trigger of oocyte maturation.

Exclusion Criteria:

* Hypothalamic dysfunction, Patients with \< 14 follicles \< 11 mm in diameter, peak serum E2 levels \>= 4,000 pg/mL.
Case Report in Complications After Laparoscopic Transabdominal Preperitoneal Groin Hernia Repair Using LiquiBandFIX8®

This an a case report about management and proving the strenght and resistance of LiquiBandFIX8® using for peritoneal closure in a laparoscopic transabdominal preperitoneal groin hernia repair. The patient had anticoagulation due to a mechanical valvula and postoperatively the patient developed a huge hematoma extraperitoneally. Relaparoscopy war performed to identify the problem and check the peritoneal closure.

This an a case report for proving the strenght and resistance of LiquiBandFIX8® using for peritoneal closure in a laparoscopic transabdominal preperitoneal groin hernia repair (TAPP). The patient had anticoagulation due to a mechanical valvula and postoperatively after TAPP the patient developed a huge hematoma extraperitoneally. The investigatorsperformed relaparoscopy for diagnostic and therapeutic reasons to check stop the bleeding and control the integrety of the peritoneal closure.

Eligibility Criteria:
Inclusion Criteria:

* Retrospective case report of one patient undergoing laparoscopic groin hernia repair

Exclusion criteria:

- not applicable (retrospective)