cyrilzakka/clinical-trials huggingface dataset:
Implementation of Optical Diagnosis of Diminutive Colorectal Polyps: DISCARD3 Study (Incorporating AI-DETECT)

This is a prospective feasibility study. The aim of this work is to assess the acceptability and feasibility of optical diagnosis-led care in bowel cancer screening patients undergoing colonoscopy. This study will determine whether bowel cancer screening colonoscopists are able to consistently record and diagnose diminutive adenomas suitable for a resect and discard strategy allowing assignment of surveillance intervals according to Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) criteria. A practical quality assurance program around optical diagnosis will be introduced. The use of a CAD polyp-detection system will also be evaluated (AI-DETECT).


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 60-74

  * with +ve Faecal Occult Blood/Faecal Immunochemical test attending for screening colonoscopy within BCSP (Bowel Cancer Screening Programme)
  * with an established history of adenomas attending for surveillance colonoscopy within BCSP
* Patients aged 55 - referred for screening colonoscopy following positive Bowel Scope Screening flexible sigmoidoscopy

Exclusion Criteria:

* Patients with a risk profile (due to family history or other) whose follow-up will be outside standard BCSP
* Patients with inflammatory bowel disease
* Unable to consent
* Pregnancy
The Effect of Motivational Interviewing Based on the COM-B Model

This research will be conducted to determine the effect of motivational interviewing based on the COM-B model on women's cervical cancer health beliefs and participation in screening.

Cancer is an important public health problem in terms of mortality and morbidity in the world and in our country, and ranks second among the causes of death. It can reduce the mortality and morbidity rate in cancer with early diagnosis and screening studies. One of the cancers for which early diagnosis and screening studies are carried out in women is cervical cancer, and it is the 4th most frequently diagnosed cancer type that causes death in women. Although early diagnosis and screening studies are carried out, women do not participate in enough cervical cancer screenings for different reasons. Interventions are needed to increase women's motivation to participate in screening. This research will be conducted to determine the effect of motivational interviewing based on the COM-B model on women's cervical cancer health beliefs and participation in screening. The research is planned as a parallel group single-blind randomized controlled experimental study and will be conducted on women between the ages of 30-65 who are registered at Altınordu Central Family Health Center in Ordu Province. The population of the research will be women between the ages of 30-65 who are registered at Altınordu Central Family Health Center, and the sample will be 74 women who meet the research criteria and agree to participate in the research. The data of the research will be collected with the "Information Form", "Cervical Cancer and Pap Smear Test Health Belief Model Scale", "Cervical Cancer Screening Status Evaluation Form" and "Satisfaction Evaluation Form". A motivational interview program based on the COM-B Model will be applied to the women in the experimental group for 1 month (1st week face-to-face, 2nd, 3rd and 4th weeks online). No intervention will be applied to the control group during the research process. The analysis of the data will be done in a computer environment by an expert statistician. Necessary institutional permissions and ethics committee approval will be obtained for the research.

Eligibility Criteria:
Inclusion Criteria:

* Registered at Altınordu Central Family Health Center,
* A woman,
* Between 30-65 years of age,
* The one who is married,
* Have not had a Pap Smear test in the last 5 years,
* Has a smart phone
* Has an internet connection,
* Open to communication and collaboration,
* Women who volunteer to participate in the study will be included in the study.

Exclusion Criteria:

* Who had total hysterectomy surgery,
* The pregnant one,
* Those diagnosed with cervical cancer and
* Women with a psychiatric diagnosis will be excluded from the study.
Universal Hemoglobin A1c Versus Risk-based Screening for Early Gestational Diabetes Mellitus (EARLY GDM): A Randomized Controlled Trial

The goal of this randomized controlled trial is to compare the rate of large-for-gestational-age neonates between universal screening with glycated hemoglobin (A1C) and early risk-based screening with a glucose tolerance test (GTT) among pregnancies that present to prenatal care at \<16 weeks 6 days.


Eligibility Criteria:
Inclusion Criteria:

* Presenting to prenatal care ≤16 6/7 weeks of gestation
* Intend to deliver at TJUH

Exclusion Criteria:

* Multifetal gestation
* Pre-pregnancy diagnosis of diabetes mellitus
* History of malabsorptive gastric bypass surgery
* Hemoglobinopathy
Orebro Musculoskeletal Screening Questionnaire-12

The research is a study with methodological design. The validity, reliability and practicality of the Örebro Musculoskeletal System Screening Questionnaire-12 will be investigated. In this context, a questionnaire will be applied to the participants to take part in the study after the translation process is completed.

Musculoskeletal disorders are quite common in developed and developing countries. Musculoskeletal disorders cause economic burdens in the individual and social field. In addition, getting reports is one of the main causes of reduced productivity and work disability. Therefore, inexpensive and easily applicable screening questionnaires are needed to determine the patient population with high risk musculoskeletal disorders. The Örebro Musculoskeletal Screening Questionnaire is a practical questionnaire that can evaluate musculoskeletal disorders and is tailored to the WHO-ICF themes. For this reason, the aim of the study is to translate the Örebro Musculoskeletal System Survey-12 into Turkish intercultural translation and to investigate the construct validity, reliability and practicality.

Eligibility Criteria:
Inclusion Criteria:

* Having any musculoskeletal problems (spine, upper or lower extremities)
* Being in the age range of 18-65

Exclusion Criteria:

* Pregnancy
* Having of red flag signs.
Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study

The purpose of the study is to evaluate how well tolerated and effective an angiotensin receptor-neprilysin inhibitor (sacubitril-valsartan) is in patients with contemporary durable continuous flow left ventricular assist device (CF-LVAD) implantation compared to usual care oral vasodilator therapy.

The aim of this pilot study is to prospectively determine the short-term (at 3 months) and long-term (at 6 and 12 months) safety and efficacy of an angiotensin receptor-neprilysin inhibitor (sacubitril-valsartan) in patients with contemporary durable continuous flow left ventricular assist device (CF-LVAD) implantation compared to standard-of-care (usual care) oral vasodilator therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Adults (age ≥ 18 years)
2. Durable CF-LVAD for any indication
3. NYHA II to IV classification
4. LVEF \< 40%
5. Written informed consent

Exclusion Criteria:

1. Inability to comply with the conditions of the protocol
2. Any patient with durable CF-LVAD who has any one of the following:

   i. symptomatic hypotension or MAP \< 60 mm Hg at randomization,

   ii. eGFR \< 30 mL/min/1.73 m2 at randomization,

   iii. potassium \> 5.4 mM at randomization,

   iv. history of angioedema at randomization,

   v. history of unacceptable side effects with ACE inhibitor, ARB, or sacubitril-valsartan therapy at randomization,

   vi. use of vasoactive agents (e.g., dobutamine, dopamine, epinephrine, norepinephrine, phenylephrine, vasopressin, nitroglycerin, nitroprusside, epoprostenol) or parenteral diuretics in 24 hours preceding randomization.
Clinical Efficacy of a Toothpaste on Hypersensitivity Reduction

Tooth sensitivity reduction after dentifrices use


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, ages 18-70, inclusive.
* Availability for the three month duration of the study.
* Two sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession.
* Qualifying response to tactile stimuli (Yeaple probe) as defined by a score between 10-50gms. of force.
* Qualifying response to the air blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.
* Subjects need to satisfy the qualifying response to stimuli for both the parameters assessed (tactile or air) on two teeth to be entered into the study.
* Good general health with no known allergies to products being tested.
* Use of a non-desensitizing dentifrice for three months prior to entry into the study.
* Signed Informed Consent Form.

Exclusion Criteria:

* Gross oral pathology, chronic disease, or history of allergy to test products.
* Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months.
* Sensitive teeth with mobility greater than one.
* Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.
* Subjects that began to take anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, or daily analgesics within one month prior to the start of the study or who have to start taking these during the course of the study.
* Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past three months.
* Current participation in any other clinical study.
* Pregnant or lactating subjects.
* Allergies to oral care products, personal care consumer products, or their ingredients.
* Medical condition which prohibits not eating/drinking for 4 hours.
Evaluating the Effectiveness of STRIMVELIS Risk Minimization Measures (RMMs)

STRIMVELIS is a medicinal product that restores adenosine deaminase (ADA) function in hematopoietic cell lineages, thereby preventing impaired immune function. STRIMVELIS is indicated for the treatment of patients with ADA- severe combined immunodeficiency (SCID), for whom suitable human leukocyte antigen (HLA)-matched related stem cell donor is not available. The objective of this study is to evaluate the effectiveness of routine and additional risk minimization measures by assessing the understanding of referring health care providers (HCPs) and parents/carers (hereby referred as participants) with regard to the specific risks associated with STRIMVELIS. In this cross-sectional study, surveys will be provided to referring HCPs and parents/carers of children approximately six months after treatment with STRIMVELIS. The study will recruit for approximately two years or until a maximum of 10 referring HCPs and 10 parents/carers have completed their respective surveys, whichever occurs first.


Eligibility Criteria:
Inclusion Criteria:

* HCPs or HCPs' close family members may not have been employees of Orchard, Pharmaceutical Product Development, LLC (PPD), the Food and Drug Administration (FDA), or the European Medicines Agency (EMA).
* HCPs must be licensed
* An HCP must not have previously completed a survey regarding STRIMVELIS educational materials.
* An HCP must have previously referred a patient for STRIMVELIS treatment.
* Parents/carers or parents'/carers' close family members may not have been employees of Orchard, PPD, FDA, or EMA.
* A parent/carer must not have previously completed a survey regarding STRIMVELIS educational materials.
* A parent's or carer's child must have previously received treatment with STRIMVELIS

Exclusion Criteria:

* No exclusion criteria
Awareness of Osteoporosis in Diabetes Mellitus Patients

Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Diabetes mellitus patients are at increased risk for developing osteoporosis. Identifying whether multiple sclerosis patients have information and awareness about this disease is crucial. This study is aimed to investigate awareness and knowledge of osteoporosis in diabetes mellitus patients.

Osteoporosis is a common disease of bone loss. The reduced bone strength predisposes an increased risk for fractures in older individuals. It can affect people from different ethnicity. Many factors increase the risk of osteoporosis, including age, postmenopausal state, glucocorticoid use, low body weight, calcium, vitamin D, immobility, and chronic inflammation. Patients with multiple sclerosis are at high risk of developing osteoporosis due to chronic inflammation and their medications. Patients' knowledge and awareness about osteoporosis are essential for early detection, implementation of lifestyle changes, and treatment compliance. This study aimed to investigate osteoporosis awareness and knowledge about osteoporosis in patients with diabetes mellitus.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of diabetes mellitus
* Must be between the ages of 18 and 99
* Must give consent to participate in the study

Exclusion Criteria:

• Not giving consent
Comparison of SureCALL® Labor Monitor® and Tocodynamometer Measurement in Preterm and Term Pregnant Women

This measurement study was designed to evaluate the performance of SureCALL® Labor Monitor® (SureCALL®) compared to the predicate Tocodynamometer device (TOCO) in preterm and term pregnant patients.

The SureCALL® Labor Monitor® (SureCALL®) is a transabdominal electromyography monitor intended to measure uterine activity. It is intended for use on pregnant women, with singleton pregnancies, using surface electrodes on the maternal abdomen. The device is intended for use by healthcare professionals in a clinical setting.

This measurement study was designed to evaluate the performance of SureCALL® Labor Monitor® (SureCALL®) compared to the predicate Tocodynamometer device (TOCO) in pregnant laboring preterm patients, nonlaboring preterm patients, and nonlaboring term patients.

This study involved 25 women at a Gestational Age of 36 weeks or less and 5 women at a Gestation Age of greater than 36 at five clinical sites. Each study subject was instrumented with two technologies for measuring uterine activity:

1. Standard tocodynamometer attached to the maternal abdomen,
2. SureCALL® with a set of abdominal surface electrodes for uterine electromyography attached to the maternal abdomen

Subjects did not recieve any interventions as a part of this study.

Eligibility Criteria:
Inclusion Criteria:

* Singleton Pregnancy
* Informed Consent Required

Exclusion Criteria:

* Multifetal Pregnancy
* Informed Consent Not Given
Comparison of Two Drugs Regimen in Treatment of Complicated Typhoid Fever in Children

This study evaluates whether XDR Typhoid fever in children can be effectively treated with monotherapy (meropenum alone), or a combination (meropenum and azithromycin).

Complicated XDR Enteric fever is a very serious systemic disease, caused by an extremely resistant mutant strain of Salmonella Typhi ( the H58 S. Typhi superbug,) that as the name suggests is resistant to not only the first but also the second tier drugs conventionally used for treatment of the same. And as such, warrants immediate antibiotic therapy, but in view of the extended antimicrobial resistance the treatment options are limited to only two effective drugs viz Carbepenem and Azithromycin, as per culture sensitivity.

So far, in the absence of universal standardized treatment protocols for XDR complicated typhoid fever in children, random use of either one or both in combination is the current practice.

However, keeping antibiotic stewardship in mind, it is imperative to ascertain whether meropenum alone is effective or should be combined with azithromycin in the treatment of this serious disease.

Our study therefore compares the efficacy of monotherapy with meropenum or combination with azithromycin based on clinical and microbiologic remission, shortened hospital stay and less chances of relapse in order to then formulate a standardized protocol to treat complicated XDR typhoid in children thus preventing yet further antimicrobial resistance.

Eligibility Criteria:
Inclusion Criteria:

Patients with extended drug resistant typhoid fever defined as culture proven typhoid fever caused by Salmonella Typhi or Para typhi resistant to Ampicillin, Chloramphenicol,Co trimoxazole,Quinolones and Ceftriaxone along with two or more of the following condition

* High grade fever spikes for more than three days
* Refusal to eat or drink
* Drowsy or Unconscious
* Convulsions
* Dehydration due to diarrhea or vomiting
* Abdominal distension with or without tenderness
* Bleeding diathesis like petechial rash, gum bleed, melena
* Jaundice or alanine transaminase more than twice of the normal range
* Thrombocytopenia less than fifty thousand
* Increase Prothrombin time and activated partial thromboplastin time
* Electrolyte imbalance like hyponatremia, hypernatremia, hypokalemia, hyperkalemia, metabolic acidosis
* Hypoglycemia
* Signs of shock like cold and mottled skin, feeble pulses, tachycardia, decreased blood pressure

Exclusion Criteria:

* Not given informed consent
* Children who need ventilator or two inotrope support
* Severe malnutrition/immunocompromised patient
Neutrophil Extracellular Traps as a Biomarker to Predict Portal Vein Tumor Thrombosis in Patients With Hepatocellular Carcinoma

The aim of this study was to investigate whether NETs markers can enhance predict portal vein tumor thrombosis in patients with live cirrhosis, so as to establish a novel predictor to guide clinical decision-making.

Eighty-six patients with patients treated at the Affiliated Hospital of Qingdao University (China) from September 2020 to January 2021 were recruited for this study, including 14 patients with portal vein tumor thrombosis, 28 patients without portal vein tumor thrombosis and 44 patients without hepatocellular carcinoma. NETs markers (Myeloperoxidase, Neutrophil elastase, Citrate histone H3), and anti-β2 glycoprotein I were detected in plasma using capture ELISA and specific ELISA kits. T-test was performed to analyze whether there was a statistical difference between the two groups, and regression analysis was performed between NETs markers and tissue factor and anti-β2 glycoprotein I to investigate whether there was a correlation. This study without any intervention measures, will not cause harm.

Eligibility Criteria:
Inclusion Criteria:

（1) Clinical diagnosis of HCC with liver cirhosis (2) Clinical diagnosis of portal vein tumor thrombosis

Exclusion Criteria:

(1) secondary liver malignancy (2)hematologic diseases (3) Bud-Chiah syndrome (4) incomplete data
Chemotherapy in Treating Children With Relapsed Acute Leukemia, Acute Myeloid Leukemia, or Blastic Phase Chronic Myelogenous Leukemia

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of topotecan in treating children who have relapsed acute leukemia, acute myeloid leukemia, or blast phase chronic myelogenous leukemia.

OBJECTIVES: I. Determine the response rate of patients with relapsed acute lymphocytic leukemia, acute myeloid leukemia, or blastic phase chronic myelogenous leukemia treated with oral topotecan. II. Determine the toxic effects and pharmacokinetics of this regimen in these patients.

OUTLINE: Patients are stratified by disease type (acute lymphocytic leukemia vs acute myeloid leukemia). Patients receive oral topotecan once daily on days 1-21. Courses repeat every 28 days in the absence of blasts in the blood, M3 bone marrow, or unacceptable toxicity. Patients are followed every 6 months until death.

PROJECTED ACCRUAL: A total of 50 patients (25 per stratum) will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven relapsed acute lymphocytic leukemia, acute myeloid leukemia, or blastic phase chronic myelogenous leukemia Refractory to conventional therapy and other therapies of higher priority May have concurrent extramedullary relapse except for testicular relapse or other extramedullary sites that may require concurrent radiotherapy

PATIENT CHARACTERISTICS: Age: 21 and under Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 times normal SGOT or SGPT less than 5 times normal Renal: Creatinine no greater than 1.5 times normal Other: Able to take oral liquid medication No GI neuropathy No other condition that may affect absorption of drug No diabetes mellitus Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior bone marrow transplantation (BMT) or peripheral blood stem cell transplantation (PBSCT) allowed and recovered At least 2 weeks since prior cytokine therapy and recovered No concurrent immune modulator therapy No concurrent cytokines including interleukin-11, interleukin-2, and epoetin alfa Chemotherapy: At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered No more than 3 prior chemotherapy regimens No other concurrent chemotherapy Endocrine therapy: No concurrent steroids Radiotherapy: No prior craniospinal radiotherapy Prior total body irradiation allowed as part of BMT or PBSCT and recovered Concurrent radiotherapy for localized painful lesions allowed Surgery: Not specified Other: No concurrent metoclopramide or cisapride to maintain motility or gastric emptying No concurrent H2 antagonists No concurrent proton pump inhibitors No concurrent antacids for gastritis, gastroesophageal reflux, or ulcers (gastric or duodenal) No antacid therapy for 6 hours before and for 90 minutes after topotecan administration
Cardiovascular Effects of Muscle Relaxation During Laparoscopic Surgery

Many surgical procedures are performed using the laparoscopic approach. However, insufflation of the abdomen (pneumoperitoneum) has detrimental hemodynamic effects. The investigators intend to investigate the effect of deep neuromuscular block and nociception guided anaesthesia on hemodynamic variables during pneumoperitoneum for lower abdominal laparoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

ASA 1-3;

* Scheduled for lower laparoscopic abdominal surgery;
* Ability to give oral and written consent;

Exclusion Criteria:

* Known or suspected neuromuscular disorders impairing neuromuscular function;
* Allergies to muscle relaxants, anesthetics or narcotics;
* A (family) history of malignant hyperthermia;
* Women who are or may be pregnant;
* Preexisting cardiac disease (any);
* Untreated or uncontrolled hypertension;
* COPD gold 3 or higher
* Preexistent esophageal pathology (stricture, tumor, diverticulum)
* Any increased risk factor for upper gastro intestinal tract bleed:
* History of GI surgery;
* History of GI bleed;
* Esophageal varices;
* Gastric or esophageal inflammation;
* Severe thrombocytopenia (less than 50k) or severely elevated INR (\>4).