cyrilzakka/clinical-trials huggingface dataset:
Relative Contribution of Brain Insulin Action for Postprandial Metabolism

The goal of this clinical trial is to clarify (i) the contribution of brain insulin action on regulation of systemic metabolism, (ii) sex-specific differences in the central regulation and (iii) the influence of the menstrual cycle in women.

Therefore, participants will undergo oral glucose tolerance tests combined with a double tracer dilution technique. This approach will be compared between days with insulin delivery to the brain as nasal spray and days with placebo spray.

This research project aims to investigate to what extent brain insulin action is responsible for the control of postprandial metabolism compared to direct effects of insulin in peripheral target tissues. Furthermore, the study will investigate sex differences and the influence of the menstrual cycle on brain-derived coordination of postprandial signaling for metabolic control.

Therefore, insulin action in the brain will be introduced by application of insulin as nasal spray (on one day) versus carrier solution as placebo nasal spray (on another day) in a randomized, blinded fashion. Spray administration will be performed 15 minutes before a 75 gram oral glucose tolerance test that will introduce a postprandial state. On placebo day, the known spillover of tiny amounts of nasal insulin into the systemic circulation will be mimicked by an appropriate i.v. insulin bolus. This approach will be combined with a double-tracer dilution technique. Labeled glucose (\[6,6-2H\]glucose) will be infused 120 minutes before and during the OGTT (180 min) and will be used to address endogenous glucose production. The glucose drink from the OGTT will be enriched with \[U-13C6\]glucose to compute the glucose appearance rate (Ra). Basal endogenous glucose production will be calculated as well as post-load endogenous glucose production and rates of glucose disappearances (Rd). Using this approach, brain-derived regulation of postprandial metabolism including endogenous glucose production, glucose disappearance, insulin secretion, and secretion of proglucagon-cleavage products (incretins) will be examined.

Eligibility Criteria:
Inclusion Criteria:

* BMI \< 24 kg/m2
* no known primary diseases
* no hormonal contraception

Exclusion Criteria:

* Alcohol or drug abuse
* Smoking
* At screening: Hb \< 12 g/dl for women and Hb \< 14 g/dl for men
* Any (clinical) condition that would endanger participant's safety or question scientific success according to a physician's opinion.
Diagnosis of Oral Precancers and Cancers Using Optic Coherence Tomography

Diagnosis of oral precancers and cancers using optic coherence tomography

Diagnosis of oral precancers and cancers using optic coherence tomography

Eligibility Criteria:
Inclusion Criteria:

* oral cancer, oral precancers

Exclusion Criteria:

* other diseases
Managing Infliximab Reinduction After Temporary Discontinuation of Drug

The primary purpose of the project is to determine what is the best schedule for restarting infliximab in patients with inflammatory bowel disease (IBD) specifically ulcerative colitis and Crohn's disease, who have undergone infliximab infusions before. The primary endpoint would be the failure rate; the need to discontinue infliximab or change treatment. A secondary aim will be to determine if infliximab drug and antibody levels can predict clinical outcomes at 1 year. Other secondary outcomes include comparing short-term and long-term steroid free remission rate, and serum and fecal inflammatory markers in response to infliximab.


Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years or older who are willing and able to provide informed consent
* HIstory of IBD (Crohn's disease, ulcerative colitis, indeterminate colitis) by standard clinical, histological, and radiographic date.
* History of stable clinical response to prior IFX induction and regular maintenance dosing, as determine by enrolling clinician.
* Prior to drug holiday, was on stable dose of infliximab for at least 3 infusions at regular maintenance intervals
* Infliximab drug holiday for at least 12 weeks.

Exclusion Criteria:

* Inability or unwillingness to provide informed consent
* Pregnant patients
* Prior history of serious infusion reaction to IFX
Digital Game Addiction and Cyberbullying in Adolescents

With the widespread use of technology and internet, digital game addiction and cyberbullying behaviors have increased among adolescents. Effective interventions are needed to prevent these behaviors. The aim of the study is to determine the effect of health education supported by motivational interviewing on digital game addiction and cyberbullying behaviors in adolescents. The research will be conducted with a randomized controlled trial design. The intervention group will receive six sessions of motivational interviewing-supported health education. Within the scope of the intervention, the first two sessions will be health education and the last four sessions will be motivational interviewing. It is planned that each session will be 35 minutes and the sessions will be implemented one week apart.


Eligibility Criteria:
Inclusion Criteria:

* Continuing 9th grade education
* Volunteering to participate in the research
* Being given permission by their families to participate in the study

Exclusion Criteria:

* Having problems understanding and speaking Turkish
* Visual-hearing impairment
* Having a neuropsychiatric disease
Asthma Learning Project

The purpose of this study is to determine the effect on knowledge and behavior of playing an educational asthma computer game during a pediatric Emergency Department (ED) asthma visit among children ages 7 - 15 years. The ED cares for a high-risk population of children who have difficulty accessing preventive care well. The addition of a computer game to usual asthma emergency care could be a simple, effective, enjoyable way to improve patients' asthma knowledge, beliefs, and management practices. This project has the potential to lead to larger studies evaluating the benefit of education with and without behavioral interventions such as motivational interviewing.

This project plans to implement and evaluate the use of a goal setting activity and the educational asthma computer game, "Quest for the Code" (Starlight Starbright Children's FoundationTM), in the ED of Seattle Children's Hospital. In a randomized trial of Spanish and English speaking children ages 7 - 15 years receiving ED care for their asthma, the investigators will evaluate the effects of the game on children's asthma knowledge, attitudes, and behaviors.

The investigators aim to compare the change in asthma knowledge and locus of control after 3 months, for children who play the computerized asthma game, versus those who receive standard care in the ED. The investigators will also compare changes in asthma severity and activity limitations over 3 months, for children who play the asthma game without goal-setting, children who playing the game with goal-setting, and children who receive standard care.

Overall, the investigators hypothesize that educational asthma game play by pediatric patients with acute asthma will improve asthma knowledge, compared with standard care.


Eligibility Criteria:
Inclusion Criteria:

* Age 7 - 15 years, inclusive.
* Patient has a history of asthma or asthma-like symptoms on at least 1 occasion, occurring at least 3 months prior to the current episode (may be verbal per patient/caregiver).
* Patient is presenting to the ED for an acute asthma exacerbation of any type or severity.
* Available for phone call or mail questionnaire in 2 weeks and 3 months.
* Parent able to read English or Spanish.
* Child able to understand spoken English or Spanish.
* Child able to use a computer and mouse or stylus.
* Provider believes the patient is likely to remain in ED for at least one hour.
* Informed consent by parent and assent from child

Exclusion Criteria:

* Child has previously participated in this study.
* Child has a hearing impairment uncompensated for by assistive listening devices.
* Significant mental disorder or cognitive impairment that the parent believes would preclude competent informed assent or game play.
* Child has a baseline motor disorder and the parent is unable to assist using a mouse and keyboard
* Child has significant medial conditions that have a pulmonary component, in addition to their asthma
The Effect of Omega-3 Supplementation on Muscle Functioning, Inflammation and Muscle Signaling

Elderly are supplemented with either Omega-3 (3 x 1.1g per day) or placebo (corn oil) during 14 weeks. The last 12 weeks, supplementation is combined with resistance exercise training (3x per week) focusing on upper leg strength. In the present project, the investigators study whether differences in muscle strength and/or muscle mass between conditions can be explained by omega-3-induced effects on systemic or muscle inflammatory signaling, or differences in muscle molecular signaling.

Elderly are supplemented with either Omega-3 (3 x 1.1g per day) or placebo (corn oil) during 14 weeks. The last 12 weeks, supplementation is combined with resistance exercise training (3x per week) focusing on upper leg strength. In the present project, the investigators study whether differences in muscle strength and/or muscle mass between conditions can be explained by omega-3-induced effects on systemic or muscle inflammatory signaling, or differences in muscle molecular signaling.

Eligibility Criteria:
Inclusion Criteria:

* aged \>= 65 years

Exclusion Criteria:

* BMI \< 20; BMI \> 35
* regular NSAID intake in the last 3 months
* omega-3 supplementation in the last year
* regular resistance exercise in the last year
* cancer, liver and renal disease, unstable cardiovascular disease, musculoskeletal disease
* cognitive limitations that might interfere with the (adherence to) the intervention or with the testing of outcome parameters
* unstable body weight
* smoking
Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body

1. purpose: To conduct the relative bioavailability study of a single dose and multiple doses of imatinib mesylate capsule (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus Glivec (Novartis Pharma Stein AG).
2. Experimental Design： Two-period crossover design
3. Test drug: imatinib mesylate capsule Reference drug: Glivec
4. Sample size：20

To conduct the relative bioavailability study of a single dose and multiple doses of imatinib mesylate capsule(Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus Glivec (Novartis Pharma Stein AG) and compare the bioequivalence and pharmacokinetics of the two products in 20 patients with chronic myeloid leukemia.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic myeloid leukemia;
* Age: 18-65 years,gender:both.
* Weight: standard weight ± 20% within, and avoid weight disparity is too large;
* No previous radiation therapy, chemotherapy, or surgery within 1 weeks before treatment with imatinib;
* Performance status 0 to 3 (WHO scale); Life expectancy greater than 3 months;
* No other malignancy;
* Adequate hepatic, renal, and bone marrow function (WBC≥3.0×109/L，ANC≥1.5×109/L，PLT≥80×109/L. Serum bilirubin≤1.5×the institutional upper limit of normal, ALT、ALP≤2.5×the institutional upper limit of normal, creatinine≤1.5×the institutional upper limit of normal);
* Ability to understand objectives of the study, the study procedure, the pharmacological properties of the drug and possible adverse reactions and the willingness to sign a written informed consent.

Exclusion Criteria:

* Suffering from heart, liver, kidney disease or severe acute and chronic gastrointestinal diseases;
* Pregnant or lactating women and be sensitive to drug;
* Subjects are thought unsuitable for the study by investigators;
* Inability to comply with protocol or study procedures in the opinion of the investigator;
* Attending other clinical trials or attended other clinical trials 3 months ago.
Novel Esophago-Jejunal Anastomosis Method During Totally Laparoscopic Total Gastrectomy

Laparoscopic gastrectomy became a good option for early gastric cancer. Surgical trend is gradually changed to totally laparoscopic gastrectomy from laparoscopy-assisted gastrectomy requiring mini-laparotomy. Various types of intracorporeal anastomosis have been introduced for esophagojejunostomy during total gastrectomy. We invented a novel anastomosis method using linear stapler for total gastrectomy. Three procedures (Jejunal resection, esophageal resection and closure of common entry hole after anastomosis) was performed with only one stapler. Therefore, the novel method is simple and fast. Also, this new technique is better economically than previously introduced anastomosis using linear stapler because lesser number of stapler is required. We want to demonstrate the feasibility of novel intracorporeal anastomosis method during laparoscopic total gastrectomy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma in stomach
* Males or Females, aged≥20 years and ≤80 years
* Without serosa invasion, extraperigastric lymph node metastasis and other organ metastasis stage in preoperative evaluation, (cT1-3N0-1M0)
* Beyond the indication of ESD
* Tumor location in high body of stomach or requiring total gastrectomy
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry
* American Society of Anesthesiolosists (ASA) score of 1 to 3
* The patient has given their written informed consent to participate in the study

Exclusion Criteria:

* Simultaneous malignancy in other organ
* Experience of previous laparotomy
* Experience of gastric resection including wedge resection
* Vulnerable subject
Assessment of Autonomic Neuronal Changes During Moderate Rise of Intracranial Pressure in Human

The purpose of this project is to determine during moderate rise of intracranial pressure (ICP) in awake patient, the change in autonomic function and its influence on cerebral and systemic haemodynamics.

From preliminary data, we know that changes in ICP influences both systemic and cerebral haemodynamics, introducing the concept of intracranial baroreflex We have to i) confirm the presence of this intracranial baroreflex, ii) analyze the changes in autonomic function during moderate rise in intracranial pressure (ICP) in human, and iii) correlate the changes in cerebral and systemic haemodynamics with autonomic function.

Eligibility Criteria:
Inclusion Criteria:

* patient suspect of hydrocephalus with gait problems, urine incontinence and mild cognitive impairment.
* signed consent

Exclusion Criteria:

* psychiatric problems
* severe cognitive decline
Dysregulation of Glutamine Activity in the Pathogenesis of Multiple Myeloma

This clinical trial studies the utilization of glutamine by the bone marrow plasma cells from patients with monoclonal gammopathy of undetermined significance (MGUS) compared to multiple myeloma (MM). Results from this study may identify metabolic differences between pre-malignant and malignant clonal plasma cells in MGUS and MM, respectively. It may also allow researchers better determine the transition from MGUS to MM for the development of potential early diagnostic purposes of preventative strategies.

PRIMARY OBJECTIVE:

I. Compare the glutamine anaplerosis activity in bone marrow clonal plasma cells (cPCs) between patients with MGUS and MM using an in vivo and an ex vivo approach.

SECONDARY OBJECTIVES:

I. Compare the tricarboxylic acid (TCA) isotopomer enrichment in the bone marrow plasma obtained from patients with MGUS and MM with the in vivo approach.

II. Determine the peripheral blood enrichment of 13C in the TCA cycle intermediates from patients with MGUS and MM with the in vivo approach.

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP I (EX-VIVO): After an overnight fast of 6 hours, patients undergo collection of blood samples.

GROUP II (IN VIVO): After an overnight fast of 6 hours, patients receive 13-carbon labeled glutamine or 13-carbon-labeled glucose intravenously (IV) over 90 minutes. Patients also undergo collection of blood and bone marrow aspirate samples.

After completion of study, patient are followed up for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* International Myeloma Working Group (IMWG) criteria for the diagnosis of either MGUS or MM

Exclusion Criteria:

* Unable to provide consent
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) \> 3
* Hemoglobin \< 8 g/dL
* Women who are pregnant
* Prior history of adverse events with conscious sedation
Treatment of Antenatal Chlamydia Infection

PREGNANT WOMEN IN ANTENATAL CLINIC WILL BE SCREENED FOR CHLAMYDIA TRACHOMATIS INFECTION WITH ENDOCERVICAL SWAB.THOSE THAT TEST POSITIVE AND SATISFY THE INCLUSION CRITERIA WILL BE COUNSELLED AND ENROLLED INTO THE STUDY AFTER OBTAINING INFORMED CONSENT.THE PARTICIPANTS WILL BE RANDOMISED INTO ONE OF THE TWO GROUPS.THE DRUGS WILL BE TAKEN FOR I WEEK AND THE SEXUAL PARTNER(S) WILL ALSO BE TREATED WITH DOXYCYCLINE FOR 1 WEEK. BARRIER CONTRACEPTION WILL ALSO BE USED DURING THE TREATMENT.THE SEXUAL PARTNERS WILL BE CONTACTED THROUGH TELEPHONE CALLS AND THE BENEFITS OF PARTICIPATING IN THE STUDY WILL BE EXPLAINED TO THEM. LATEX MALE CONDOM WILL BE GIVEN TO THE WOMEN. ALSO, FOLLOW-UP TELEPHONE CALLS WILL BE PUT ACROSS TO THEM DURING THE TREATMENT WEEK TO ENHANCE COMPLIANCE. A REPEAT ENDOCERVICAL SWAB WILL BE TAKEN 4 WEEKS AFTER TREATMENT TO CHECK FOR MICROBIOLOGICAL CLEARANCE. A STUDY PROFORMA WILL BE FILLED DURING THIS VISIT. THE DATA WILL BE ANALYSED USING STATISTICAL PACKAGE FOR SOCIAL SCIENCES VERSION 17.

AIM(S) OF THE RESEARCH TO ASSESS THE EFFICACY AND TOLERABILITY OF AMOXICILLIN COMPARED TO ERYTHROMYCIN IN TREATMENT OF ANTENATAL CHLAMYDIA INFECTION

OBJECTIVES OF THE RESEARCH

* TO DETERMINE THE PREVALENCE OF CHLAMYDIA TRACHOMATIS INFECTION IN PREGNANCY
* TO COMPARE THE PROPORTION OF SUBJECTS WITH CLEARANCE OF ANTENATAL CHLAMYDIA TRACHOMATIS INFECTION BETWEEN THE ERYTHROMYCIN AND AMOXICILLIN GROUPS
* TO COMPARE THE OCCURENCE OF SIDE EFFECTS BETWEEN THE TWO GROUPS
* TO COMPARE THE DRUG DISCONTINUATION RATES BETWEEN THE TWO GROUP

Eligibility Criteria:
Inclusion Criteria:

1. Test positive to Chlamydia rapid screening kit
2. Estimated gestational age less than 36 weeks
3. Consent to participate in the study
4. Willingness or ability to comply with follow-up schedule

Exclusion Criteria:

1. Antenatal patients whose gestational age is more than 36 weeks
2. History of reaction to any of the drugs
3. Women with low lying placenta or placenta Praevia
4. History of other antibiotics intake within two weeks of recruitment
Satisfaction, Confidence and Naturalness in Men With Psychogenic Erectile Dysfunction (ED)

Context and Objectives: Erectile dysfunction severely compromises not only sexual satisfaction, which is well known to be closely linked to overall life satisfaction but is also associated with a lower quality of life, lower self-esteem, depression, anxiety and adverse effects on interpersonal relationships. The objective was to assess the efficacy of psychotherapy and/or sildenafil for psychogenic erectile dysfunction.

Design and Settings: randomized controlled single-blind trial performed at Institute of Psychiatry of the Medical School of at Universidade de São Paulo, São Paulo, Brazil Methods: Thirty patients with mild and moderate psychogenic erectile dysfunction (ED) were randomized to receive for six months: group psychotherapy (GP) plus 50mg sildenafil on demand, or 50mg sildenafil exclusively, on demand, or GP exclusively. Changes in score from baseline for three questions of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) were evaluated at end-point and after 3-months follow-up.

Results: satisfaction with the treatment, confidence and naturalness increased in GP plus sildenafil and GP exclusively groups (p=0.001) from baseline to endpoint. The treatment-by-time comparison was not significant at end point versus 3-month follow-ups, in the three groups. No difference was observed in the sildenafil group in the three study periods (P \>0.05) Conclusions: Patients with mild and moderate psychogenic ED had higher treatment satisfaction, confidence and naturalness in engaging in sexual activity when receiving GP plus sildenafil or GP exclusively, when compared with sildenafil exclusively, as assessed by these three EDITS questions after 6-months treatment


Eligibility Criteria:
Inclusion Criteria:

1. exclusive diagnosis of psychogenic ED, using a checklist for DSM-IV criteria.Morning erections, situational erections (masturbatory or with another partner), or acute onset are characteristics of psychogenic ED;
2. age between 25 and 50 years;
3. mild and moderate erectile dysfunction according to the International Index of Erectile Function (IIEF);
4. stable heterosexual relationship for at least 1 year, and in accordance with inclusion criteria during short-time psychotherapy focused on sexuality; (f) informed consent from the patient.

Exclusion Criteria:

Patients were excluded if presenting significant clinical diseases, major depressive disorder or other severe mental disorder, primary no erectile sexual disorder (e.g., hypoactive sexual disorder), penile anatomic defects; users of medications that could interfere with sexual function; patients with any kind of physical limitations for the use of sildenafil citrate (current use of nitrates, past history of retinitis pigmentosa, allergies); and significant drug, alcohol or tobacco use
Prophylactic Phenylephrine Co-administration During Caesarean Section

This single centre prospective alternating intervention study will aim to compare prophylactic phenylephrine given in the first litre of Ringers lactate as co-load in healthy patients having an elective caesarean section under spinal anaesthesia at Edendale Hospital to the existing national protocol guideline - for the treatment of obstetric spinal hypotension.

Spinal anaesthesia is currently standard of care for patients undergoing caesarean section. Obstetric spinal hypotension is a common and important problem, related to important maternal and foetal outcomes. The prevention and treatment of spinal hypotension has been well researched in resource-rich settings, a context different from that encountered in the South African setting. It has been previously shown that a prophylactic phenylephrine infusion is effective in resource-limited settings, but this method is still dependent on the availability of an infusion pump.The ideal dose offering the best risk to benefit profile is 25 to 50 mcg/min. It has recently been shown that a prophylactic phenylephrine infusion, administered by an infusion pump, appears safe and effective in resource-constrained environments. However, some institutions in South Africa are limited by a lack of available infusion pumps. There is an urgent need to translate these research findings into a pragmatic management strategy that is safe and effective where this equipment is lacking. A 18g Jelco allows flow of approximately 100 ml/min in the absence of a pressure bag: therefore with 500 mcg in 1000 ml of ringers lactate and a fully opened line, a maximum dose of 50 mcg.min-1 will be achieved. If the rate is 50 ml/min (20 minutes for the first litre) the dose will be 25 mcg.min-1. This dose range will offer maximum benefit with low risk of side effects.

This exploratory study will establish if a phenylephrine (500 mcg) bolus, added to the first litre of Ringers lactate given as a co-load, is an effective and safe means to prevent post obstetric spinal hypotension. This regime will be compared to the existing South African national protocol of the management of obstetric spinal hypotension. The findings of this study will provide valuable information regarding a safe and potentially effective means to prevent obstetric spinal hypotension.

Eligibility Criteria:
Inclusion Criteria:

* All ASA 1-2 patients undergoing elective caesarean

Exclusion Criteria:

* ASA grade \>2 Hypertensive disease in pregnancy Dysrhythmia Failed spinal requiring conversion to a general anaesthetic