cyrilzakka/clinical-trials huggingface dataset:
Effect of Metformin and Cholecystokinin-mediated Gallbladder Emptying on GLP-1 Secretion in Type 2 Diabetes

Accumulating evidence suggests that bile acids in our intestines may constitute essential components in the complex mechanisms regulating gut hormone secretion and glucose homeostasis. Thus, it is likely that modification of the enterohepatic circulation of bile acids can lead to changes in gut hormone secretion and consequently affect glucose homeostasis.

The current study is a human interventional randomized controlled cross-over study including four study days for each participant. Metformin will be applied as a tool to reduce bile acid reuptake in the small intestine; thereby increasing bile acid concentration in the more distal parts of the gut where GLP-1-secreting L cell are abundant. Interestingly, metformin has been shown to reduce the active reabsorption of bile acids in the ileum and cause increased faecal elimination of bile acids. Clinical data has suggested that metformin causes an increase in the postprandial secretion of GLP-1 in humans including patients with type 2 diabetes. Intravenous infusion of cholecystokinin will be used to elicit gallbladder contraction and emptying. The aim is to examine how (and if) modification of bile acid reabsorption can influence postprandial glucagon-like peptide-1 (GLP-1) secretion and glucose homeostasis in patients with type 2 diabetes.

The investigators hypothesize that higher luminal concentrations of bile acids in the distal gut will elicit changes in gut hormone secretion. The current study will help to clarify this hypothesis and improve our general understanding of the association between bile acid circulation and signalling, gut hormone secretion and glucose metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least 3 months (diagnosed according to the criteria of the World Health Organization (WHO))
* Men and postmenopausal women
* Metformin applied as the only anti-diabetic drug
* Caucasian ethnicity
* Normal haemoglobin
* BMI \>23 kg/m2 and \<35 kg/m2
* Informed and written consent

Exclusion Criteria:

* Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) \>2 times normal values) or history of hepatobiliary disorder
* Gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery
* Nephropathy (serum creatinine \>150 µM and/or albuminuria)
* Hypo- and hyperthyroidism
* Hypo- and hypercalcaemia
* Hypo- and hyperphosphataemia
* Active or recent malignant disease
* Treatment with medicine that cannot be paused for 12 hours
* Treatment with oral anticoagulants
* Any treatment or condition requiring acute or sub-acute medical or surgical intervention
* Any condition considered incompatible with participation by the investigators
Malignant Genito-urinary Tumors in Children: South Egypt Cancer Institute Experience

The aim of this study is to identify demographic \& disease characteristics in pediatric oncology patients diagnosed with one of genitourinary tumors \& treatment outcomes in these patients.

Background:

Tumors of the kidney, bladder, prostate, testis, and adrenal represent a large part of the adult urologic practice, but are relatively infrequent in children.

Genitourinary tumors contribute to pediatric solid tumors. Wilms tumor, rhabdomyosarcoma, and germ cell tumors are the most common malignant genitourinary tumors in children.

The natural history and management of these tumors in the pediatric age is different from that of the adults. As result of the successful work of several clinical trial groups in recent decades, there has been a significant improvement in their cure rates.

Patients \& Methods:

From January 2001 till December 2015, retrieval \& analysis of the medical records of pediatric patients with genitourinary tumors will be made at the pediatric oncology department, South Egypt Cancer Institute which represents the largest referral center in Upper Egypt. These data will be categorized according to demographic characteristics, clinico-pathologic features, treatment modalities received, and outcomes of treatments in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients whose age less than or equal to 18 years.
* Patients diagnosed with any of neoplasms affecting the genitourinary system.

Exclusion Criteria:

* Patients whose age more than 18 years.
Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients

The purpose of this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.


Eligibility Criteria:
Inclusion Criteria:

* Full-term or gestational age \>/= 28 to 44 weeks
* In-patient in Neonatal Intensive Care Unit, special care nursery, or equivalent
* Patient must be on a stable mode of feeding or with minimal variations for at least 2 days prior to randomization

Exclusion Criteria:

* Patients with a need for resectional or reconstructive surgery of the gastrointestinal tract
* Patients with any condition that may require surgery during the course of the study
* Patients with acute respiratory distress within 72 hours prior to enrollment
Effect of Tetrix on Alleviation of Burning,Itching Associated With Lesions of Contact Dermatitis

To determine if Tetrix Cream, when applied to the skin lesions on patients with contact dermatitis, improves the symptoms of burning and itching.


Eligibility Criteria:
Inclusion Criteria:

1. Normal subjects with sensitivity to nickel
2. Subjects with hand eczema

Exclusion Criteria:

under 18 years of age
The Impact of Using a Smartphone Health Application in the Improvement of Cardiovascular Disease Risk Factors

This study investigates the effectiveness of Mobile health application (mHealth apps) in the improvement of cardiovascular disease risk factors including metabolic and behavioral factors. The app will be tested on patients with any of the modifiable risk factors of CVD such as hypertension, obesity, hyperlipidemia, and impaired glycemic control/type 2 diabetes mellitus .

The investigators aim in this study to reduce the risk of cardiovascular disease in patients with hypercholesterolemia, diabetes, obesity and hypertension. This will be achieved by motivating healthy lifestyle among the participants such as increasing physical activity and intake of healthy diet and reducing alcohol and tobacco consumption. The tool which will be used to motivate healthy lifestyle is a smartphone application which will be specifically designed to motivate behavioral change. Thus, the investigators hypothesis is that participants who have full access to the mobile application will show improved healthy lifestyle, reduced blood pressure, cholesterol and glucose and reduced BMI compared to the participants who don't have access to the mobile application.

Eligibility Criteria:
Inclusion Criteria:

* Presentation with at least one of the following metabolic abnormalities:
* Hypertensions (systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥ 85 mmHg)
* Obesity (waist circumference ≥ 80 cm (women) or ≥ 94 cm (men) and BMI ≥ 25 kg/m2)
* Dyslipidemia (triglycerides ≥ 1.7 mmol/L or/and HDL-cholesterol ≤ 1.29 mmol/L (women) or ≤ 1.02 mmol/L (men) or/and LDL-Cholesterol \> 5.18 mmol/L, serum total cholesterol ≥ 5.2 mmol/l)
* Impaired glycemia/type 2 diabetes (fasting plasma glucose ≥ 5.6 mmol/L)
* Arabic or English language speaking and able to read and write in one of these languages
* Possession of a smart mobile phone Willing to utilize a mobile application for CVD management.

Exclusion Criteria:

* A history of stroke, myocardial infarction or any related cardiovascular complications Complicated diabetes mellitus e.g., Proliferative diabetic retinopathy, end-stage renal disease
* Unavailability of a smartphone or any reason that will not allow the participant to use the app properly. (such as; difficulty or inability to use mobile applications, unavailability of network services...etc.).
* Medical conditions that restrain the participant to be physically active.
* High chance of loss to follow up at the FAMCO clinic (due to upcoming travel, temporary employment and thus eligibility to be treated at the clinic, irregular visits due to distance from home...etc.)
Effect of Propranolol on the Autonomic Nervous System and Muscle Pain

The project's primary purpose is to test the hypothesis that oral administration of a low single dose of β-antagonist propranolol (40 mg) reduces pain sensitivity in patients with masticatory muscle pain.


Eligibility Criteria:
Inclusion Criteria:

* Meet Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) for myofascial TMD diagnosis corresponding to group 1a or 1b
* Characteristic Pain Intensity (CPI) more than or equal to 20 (Axe II, RDC/TMD questionnaire)
* Women of childbearing potential must use adequate contraception
* Signed consent statement

Exclusion Criteria:

* Other acute pain cause such as acute toothache or a pain condition the investigator estimates to be contraindicated for participation in the experiment
* Recognized existing malignancy or within last 5 years
* Known HIV
* Abuse of drugs including alcohol
* Recognized Raynaud's syndrome
* Former sympathectomy
* Known cardiovascular disease including abnormal EKG and blood pressure (ECG-12 is recorded before the first trial session and assessed by the physician)
* Recognized lung insufficience, including bronchial asthma
* Known severe hepatic or renal dysfunction
* Known diabetes mellitus
* Known severe depression
* Pregnancy (tests performed in both sessions 1 and 2 before the start of a session)
* Fertility Treatment
* Lactation
* Post-menopausal
* Previous adverse reaction when taking beta-blocker, including hypersensitivity to propranolol or to any of the excipients
* Patients who can not read and understand the written information
* Patients who can not follow the protocol
* Patients who do not agree to comply with the requirements for participation in both studies regarding food intake, physical activity, etc.
Effects of Integrated And Isolated Resisted Exercise on Strength, Power And Endurance

Resistance training and strength training are synonymous terms used to denote a component of sport and exercise training that is designed to enhance muscular strength, muscular power, and local muscular endurance for general exercise or competitive sports. Resistance training is a specialized method of conditioning that involves the use of different modes of training with a wide range of resistive loads, from body weight to barbells. Resistance-training programs may include the use of free weights (barbells and dumbbells), weight machines, medicine balls, kettlebells, elastic tubing, or a person's own body weight to provide the resistance needed to increase strength.

Objective of study is to compare the effects of integrated and isolated resisted exercise on strength, power and endurance in gym beginners. Design of the study is randomized clinical trial. Data will be collected from body choice gym township, Lahore. Performance, strength, power and endurance will be measured by using Borg Rating of Perceived Exertion (RPE) scale, 1RM maximum, Anthropometry. One Group participants will received integrated resisted training session and other group will train with isolated resisted training.

The objective of this study is to compare the effects of integrated and isolated resisted exercise on strength, power and endurance in gym beginners.Resistance training is one of the most popular training approaches adopted by coaches professionals. Due to the limited number of literature on athletes, it's forever a challenge for physiotherapists in to enhance functional performance in players by implementing these techniques.

The basic purpose of this research is to find and compare the effects of integrated and isolated training on strength, power and endurance in gym beginner. The study can help coaches and trainers to identify the most effective training methods for improving strength, power and endurance.Previous literature show that resisted exercises play effective role in gym trainer for strengthening, power and endurance. But there is a limited literature on comparing the effects of integrated and isolated resisted exercise so our focus is to measure the role of these techniques for strength, power and endurance in gym beginners.

Eligibility Criteria:
Inclusion Criteria:

* • Age: 18-30 years

  * Male gender only
  * Participants join the gym having duration less than 6 months

Exclusion Criteria:

* Engaged in regular exercise program within the past 6 months

  * History of lower limb injuries or surgeries within the past 6 months
  * Chronic diseases that affect physical function, such as cardiovascular disease, diabetes, or neurological disorders
Procalcitonin in Hepatocellular Carcinoma

the value of serum procalcitonin in differentiation between bacterial infection and non infectious inflammation in febrile HCC patients following locoeregional treatment for HCC.


Eligibility Criteria:
Inclusion Criteria:

1. - Hepatocellular carcinoma patients who will undergo TACE and/or radio-frequency.
2. - Fever more than 38C after 48 hours post intervention.

Exclusion Criteria:

1. HCC Patients who does not develop fever after intervention.
2. Proven infection elsewhere (e.g. UTI, chest infection..)
Vertical GBR LPRF Block vs. Autogenous Bone With DBBM

split-mouth RCT, 25 months follow up. GBR protocol with LPRF as grafting material in the test group and autogenous bone with DBBM as grafting material in the control group.

6 patients were included in this split-mouth RCT. In control sites a horizontal GBR procedure was performed using a titanium reinforced dPTFE membrane with a graft consisting of 50% autogenous bone and 50% DBBM. In test sites a titanium reinforced dPTFE membrane was used, with a graft consisting of an LPRF block. This was left to heal for 9 months. Subsequently an implant was placed. At time of implant placement a bone biopsy was taken. After 4 months of osseointegration the abutment connection was performed. 1 year after loading of the implants a final check was done. CBCT scans were taken at intake, immediately after reconstruction, 9 months after reconstruction, before implant placement and 1 year after loading of the implants.

Primary outcome measure is the bone volume as measured on the CBCT scans. Secondary outcome measures are bone quality in the biopsy, buccal bone thickness around the oral implant, number and type of complications, cumulative survival rates of the implants 1 year after loading.

Eligibility Criteria:
Inclusion Criteria:

* Males or females, with ASA I or II, between 18 and 80 years old
* 2 implant sites requiring vertical bone augmentation prior to implant placement
* Both sites in the same jaw
* Good general health as documented by self-assessment

Exclusion Criteria:

* Any systemic medical condition that could interfere with the surgical procedure, planned treatment or healing of the patient
* Immunosuppression, Diabetes, Anticoagulation or Antiaggregatory medication.
* Current pregnancy or breast feeding/ lactating at the time of recruitment.
* Radiotherapy or Chemotherapy in head and neck area.
* Intravenous and oral bisphosphonate therapy.
* Smoking
* Unwillingness to return for the follow-up examination.
* Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unrealistic expectations
* Presence of osseous pathologies, that might interfere with normal wound healing
* Presence of oral lesions (such as ulceration, malignancy)
* Local inflammation, including untreated periodontitis
* Patients with inadequate oral hygiene or unmotivated for adequate home care
A Study to Investigate the Bioequivalence of Lacosamide 200mg Administered as Intravenous Solution and Oral Tablet in Healthy Chinese Male Subjects

The purpose of this study is to assess the bioequivalence of a 200 mg single dose Lacosamide (LCM) intravenous (iv) solution with a 200 mg single dose LCM oral tablet in healthy Chinese male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a Chinese male between 18 and 40 years of age
* Subject has no clinically significant cardiovascular, renal, gastrointestinal, hepatic, metabolic, endocrine, neurological, or psychiatric abnormalities and is in general good health
* Subject confirms that during the study and for a period of 3 months after the final dose of study drug, when having sexual intercourse with a woman of childbearing potential, an acceptable birth control method will be used

Exclusion Criteria:

Clinically relevant

* out of range values for hematology and clinical chemistry variables
* abnormality in physical examination or vital signs
* ECG finding

Any clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study
SHARPEN - Parkinson's Disease Dementia

The purpose of this single arm study is to evaluate the feasibility and safety of treatments with a non-invasive neuromodulation device in adults diagnosed with mild/moderate Parkinson's disease dementia (PDD). A non-invasive device is a device that stays outside of the body and is not implanted and does not penetrate the skin.

Neuromodulation means that the device stimulates activity in the brain.

Up to 12 participants will self-administer treatments twice daily in the home setting over a period of 12 weeks. There are 4 study center visits, including an eligibility visit, as well as multiple phone calls.

Eligibility Criteria:
Inclusion Criteria:

* Participants with clinical diagnosis of probable PDD
* Positive response to levodopa and have been treated with levodopa-based therapies for minimum of one years
* Participants must be willing and able to comply with all study requirements
* Participants must expect that the participant will be able to remain on a stable regimen of concomitant therapies used for the management of PD and not to introduce new medications used to treat PD (motor or non-motor symptoms) during the study
* Participant must have a study partner (defined as someone who sees the participant for more than three hours a day, 5x per week) that is willing to consent and participate in the trial.

Exclusion Criteria:

* Participant anticipates being unable to attend all visits and complete all study activities during the trial
* Women of child-bearing potential who are pregnant or plan to become pregnant during the course of the trial
* Has experienced a heart attack, angina, or stroke within the past 12 months or transient ischemic attack (TIA) within the past 6 months
* Are being treated with another neurostimulation device
* Demonstrate suicidality
* Have been previously diagnosed with either central vestibular dysfunction (lifetime) or have experienced l peripheral vestibular dysfunction within the last 12 months.
* Have active ear infections, perforated tympanic membrane or labyrinthitis, as identified by a general ear examination
* Have a recent history of frequent ear infections (≥ 1 per year over the past two years)
* Have a cochlear implant, myringotomy tubes or hearing aids that cannot be easily/reliably removed for treatment
* Have chronic tinnitus
Feasibility of Home Based Transcutaneous Spinal Cord Stimulation for Persons With SCI

The proposed study will focus on the feasibility of and effectiveness to a home-based program for persons with chronic SCI focused on upper limb training augmented with a transcutaneous neurostimulator supported via a video telehealth platform.

The overarching goal of this study is to train participants with tetraplegia and their companion to operate a non-invasive surface applied neurostimulation unit (ONWARD, ARCex) while performing a prescriptive functional task based upper extremity home program for 2 months. Participants will be supported with video-telehealth to assist with any difficulties that may arise and to progress their upper extremity home program. Evaluations will assess the feasibility of this video telehealth supported model as measured by the ease of use of the technology (QUEST 2.0, NASA-TLX) as well as participants ability to attend and complete all the training visits. Changes in upper extremity physical function will be measured using validated clinical tools (GRASSP, CUE-Q, DASH, COPM) as well as detailed evaluation of upper extremity muscle activation from surface EMG and strength measurements of pinch and grasp.

The primary outcome measure of this study is feasibility, and the secondary outcome measure is to capture changes in upper extremity performance.

Eligibility Criteria:
Inclusion Criteria:

1. Veteran
2. Age 18-65
3. All gender, any ethnicity
4. Cervical Spinal Cord Injury C2-8
5. American Spinal Injury Association (ASIA) Impairment Scale (AIS) B, C or D
6. GRASSP-Prehension Score \>10 or GRASSP Strength Score \>30
7. Greater than 1 year post injury
8. Able to identify a companion to assist with neurostimulator setup in home environment.
9. Internet connection to support video telehealth connection
10. Willingness to travel to the VA Palo Alto Medical Center

Exclusion Criteria:

1. Cardiopulmonary disease or cardiac symptoms,
2. Autonomic dysreflexia that is uncontrolled or severe,
3. Implanted medical device(s),
4. Uncontrolled spasms that could limit participation in exercise training,
5. Skin breakdown or active pressure injury in areas of electrode placement.
6. Participants must not be engaged in any concurrent drug or device trial
7. Pregnant, are planning to become pregnant, or breastfeeding
8. The study is not deemed safe or appropriate in the opinion of the investigators
Postoperative Pain Management After Minimally Invasive Aortic Valve Surgery

The study evaluates the efficacy of local anesthestic application through the catheter in the surgical wound for the postoperative pain relief after minimally invasive aortic valve surgery. The patients will be enrolled in two different groups according to the protocol of the local anesthetic and saline administration:

1. group: continous infusion of the local anesthetic plus bolus on demand
2. group: continous infusion of saline plus bolus on demand For all patients metamizol every 12 hours plus bolous of piritramid on demand.

Patients undergoing minimally invasive aortic valve replacment surgery will be enroled in the study, after giving a signed informed consent.

The study evaluates the efficacy of local anesthestic application through the catheter in the surgical wound for the postoperative pain relief after minimally invasive aortic valve surgery.

Patients will then be randomised in two groups according to the protocol:

1. group: continous infusion of the local anesthetic plus bolus on demand
2. group: continous infusion of saline plus bolus on demand

All patients will receive Metamizol every 12 hours plus bolus of piritramid on demand.

Analgesia effectivness will be checked hourly according to the visual analogue scale (VAS). According to protocol, bolus will be given every time the score of VAS scale is \>3.

The catheter will be removed 48 hours after the protocols' start.

Eligibility Criteria:
Inclusion Criteria:

* Patients after minimally invasive aortic valve surgery
* Patients agreement with the study

Exclusion Criteria:

* Age under 18 years
* Allergy to local anesthetic