cyrilzakka/clinical-trials huggingface dataset:
The PowerSpiral Antegrade Investigational Device Exemption (IDE) Study

To evaluate safety and efficacy

The purpose of this study is to evaluate the safety and efficacy of the PowerSpiral™ Enteroscopy System, when used in subjects undergoing antegrade (per-oral) enteroscopy of the small bowel.

Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 22 years of age
* Medical indication for antegrade enteroscopy
* Willing and able to provide informed consent

Exclusion Criteria:

* Any medical contraindication to standard enteroscopy
* Any test that is done as part of the standard of care that would prevent the enteroscopy from being performed for safety reasons
* Unable or unwilling to provide informed consent
* Female and of child-bearing age who is currently pregnant or planning to become pregnant within the study period
* Presence of any intra-luminal or extra-luminal foreign body in the abdominal cavity
* Any prior gastric, small bowel or colonic surgery, or implantable devices in these locations (cardiac pacemakers and non-abdominal implants are acceptable)
* Known or suspected bowel obstruction, or history of bowel obstruction
* Taking anti-platelet agents or anticoagulants (other than aspirin) within last 7 days
* Known coagulation disorder
* Known or suspected esophageal stricture or Schatzki ring
* Known gastric or esophageal varices
* Suspected perforation of the gastrointestinal (GI) tract
* Previous abdominal radiation
* Inability to tolerate general anesthesia for any reason
* Inability to tolerate endotracheal intubation
* Known need for endoscopic retrograde cholangiopancreatography (ERCP) during enteroscopy
* American Society of Anesthesiologists (ASA) Classification 4 or greater
Dietary Fructose on Microbiota and Hepatosteatosis

The consumption of sugar-sweetened beverages (SSB) has increased steadily over the past decades, resulting in the dramatic increase of fructose intake as it is one of the main ingredients of artificial sweeteners. Recently, large epidemiological studies have documented the association between a high-fructose-diet and hepatic steatosis, and other metabolic disorders. So it is interesting for scientists to explore the underlying mechanism. This study aims to investigate the effect of dietary fructose and gut microbiota and the hepatosteatosis in healthy men. Serum and fecal metabolomics will be investigated.

This is a single center, randomized, controlled study. 60 healthy men will be recruited according to the inclusion criteria. All subjects are randomly allocated to Group A and Group B, who orally takes 75g and 150g fructose daily respectively. Subjects in Group A will be instructed to drink fructose solution containing 75g fructose per day, and those in Group B will be instructed to drink fructose solution containing 150g fructose per day. The intervention will last four weeks. The anthropomentric data will be collect with questionnaire and serum and fecal samples collected at baseline and the end of the intervention. The effect and mutual interaction of dietary fructose and microbiota will be explored. The effect of dietary fructose on hepatosteatosis will be investigated as well.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy men aged from 18 to 40 (including both ends);
2. Body mass index (BMI) ranges from 18.5 to 23.9 kg/m2 (including both ends);
3. The body weight has not changed dramatically in the past 3 months (±3kg);

Exclusion Criteria:

1. Subjects who have received antibiotic-related treatment, proton pump inhibitor treatment, or glucocorticoid hormone treatment within 1 month before enrollment;
2. Subjects with diabetes or cardiovascular disease or other chronic diseases who require long-term medication;
3. Subjects who suffered from an acute gastrointestinal diseases within the past month, or who have an history of chronic gastrointestinal disease or hepatitis;
4. Subjects with a history of gastrointestinal surgery;
5. Subjects with abnormal liver or kidney function, or severe cardiovascular diseases;
6. Subjects with mental disorders or impaired cognitive function;
7. Poor compliance;
8. Participates enrolled in other clinical research at the same time;
9. Other unsuitable occasions judged by clinicians..
Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes

1. Determine the feasibility of generation of autologous Acute Myelogenous Leukemia (AML) or Chronic Myelogenous Leukemia in myeloid blast crisis (CML/BC) derived dendritic cell activated lymphocytes (DC/AL) in poor prognosis patients.
2. Determine the toxicity of autologous leukemia derived dendritic cell activated lymphocytes (DC/AL) in patients with AML or CML/BC.
3. Quantitate circulating immune effector cells in patients after infusion of DC/AL.
4. Record the efficacy of AML or CML/BC derived dendritic cells and activated lymphocytes in promoting and sustaining remission in patients with AML or CML/BC.

Most patients relapsing with AML either fail to achieve second remission or have only brief remissions. Patients more than 60 years of age or having histories of antecedent hematological disorders, prior chemotherapy, or poor risk cytogenetics have generally only short remissions and as a group have two year survivals of less than 10%. Equally patients with myeloid blast crisis of CML often fail to achieve remission or have responses of only brief duration. Laboratory studies have shown that AML leukemic blasts may be induced in culture to differentiate into dendritic cells which in turn may be used activate autologous lymphocytes to acquire leukemia specific cytotoxicity. This trial will assess the feasibility of generation of dendritic cell activated lymphocytes, and toxicity and efficacy of these activated cells given after reinduction chemotherapy. Before this study begins some toxicity information will have been generated in a trial of similar cells given to CML patients.

Eligibility Criteria:
Inclusion:

* AML patients either after first relapse or at diagnosis a) with high-risk cytogenetics such as -7, -5, +8, chromosome 9 or 11 abnormality, or b) WBC \> 50,000, or c) age \> 60 years\*.
* AML patients are eligible for cell collection if they have \> 1000 circulating blasts/mm at diagnosis.
* CML patients in myeloid blast crisis with \> 1000 circulating blasts/mm.
* Creatinine \<2, Bilirubin \<3.
* Age \>18.

Exclusion:

* Factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.
* Concurrent or expected need for therapy with corticosteroids.
* Positive antibody to human immunodeficiency virus I.
* Acute promyelocytic Leukemia (FAB-M3).
* History of overt cardiac failure, systemic autoimmune disease or expected need for steroid therapy.

  * Patients \>60 will be eligible for study but if found to have good prognosis cytogenetics (inversion (16) or t(8;21)) will subsequently be withdrawn from study and treated off protocol without infusion of autologous leukemia derived cells.
Study of the Effect of Dosing on Clozapine Levels

The objectives of this 15-day study are:

1. To compare steady-state trough plasma concentrations of clozapine and its metabolite norclozapine when given once daily and twice daily (at the same total daily dose)
2. To determine if frequency of clozapine administration has an effect on:

   1. Symptoms of schizophrenia
   2. Adverse effects of clozapine
   3. Fasting blood glucose, lipids, creatinine, and urea
   4. Weight and waist circumference

It is important that clinicians do everything possible to optimize the use of clozapine in individuals with treatment-resistant schizophrenia. To our knowledge, there are no published studies evaluating whether twice daily administration of clozapine is better than once daily administration in terms of effectiveness and tolerability. Although this may seem trivial at first, when we consider that clozapine has a relatively short half-life and dissociates quickly from the dopamine D2 receptor, it justifies further consideration. It takes on even more significance knowing that the established threshold clozapine plasma concentration for therapeutic response (i.e., 350-420 ng/ml) was determined using steady-state trough plasma samples (i.e., approximately 12 hours after the evening dose) in patients administered clozapine twice rather than once daily.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be between the ages of 19 - 65
* Participants must be fluent in English
* Participants must have a psychiatric diagnosis and are currently treated with clozapine once daily in the evening
* Participants must be on a stable dose of clozapine for at least one week to ensure steady-state has been achieved

Exclusion Criteria:

* Participants who are hypersensitive to clozapine
* Participants who are pregnant or lactating
* Participants who are of childbearing age and not using reliable contraception
* Participants who have postsurgical complications of the gastrointestinal tract that might impair absorption
* Participants who have any clinically relevant abnormalities of laboratory parameters
* Participants who have had a potent CYP1A2 metabolic inducer (e.g., carbamazepine; rifampin) or inhibitor (e.g., amiodarone; cimetidine; efavirenz; fluoroquinolone antibiotics; ticlopidine) added to and/or removed from their medication regimen in the past two weeks
Streptococcus Mutans Cariogenicity by Real-time PCR in High Caries Risk Patients

In patients with high caries risk, will the use of cinnamon extract or chlorohexidine based mouthwashes have an effect on the percentage of recovery and cariogenicity of Streptococcus mutans (SM) detected by real-time Polymerase Chain Reaction (PCR) over one month follow up

This clinical study will be held in the clinic of conservative dentistry department, Faculty of Dentistry, Cairo University. The operator in charge will be Mostafa Mahmoud El-Ghazali. Patients will be examined and selected according to inclusion and exclusion criteria, the purpose and method of the study will be explaned to the selected patients, written informed consent will be obtained from the patients for participation in the study. In the first visit, ADA caries risk assessment model will be done. Participants will be divided into two groups according to the tested mouthwashes.

All patients will be instructed not to have breakfast and to refrain any oral hygiene measures on the day of sample collection to avoid the inﬂuence of food consumption and contamination on the composition of saliva. The patient will sit in an erect position on the dental chair and will be given paraffin block to chew. The stimulated saliva will be collected after 2 minutes of paraffin chewing in sterile containers held near the mouth. The containers will be properly labeled. The study will be carried over a period of one month, the saliva samples for each patient will be collected on the ﬁrst dental visit. These samples will be then sent to the laboratory for microbiological assessment. Patients will be provided with mouthwashes according to the tested groups and they will be instructed to use it 2 times per day for 1 minute each time and no eating or drinking permitted for a minimum of 30 minutes post rinsing. Each patient will be given the same instructions with respect to oral hygiene measures. They will be advised to continue on same diet and will be instructed not to change their dietary habits. Patients will come after 2 weeks for salivary samples collection and samples will be sent to the laboratory for microbiological assessment. After treatment continuity for another 2 weeks, patients will come for the last visit to collect the salivary samples which will be sent to the laboratory for microbiological assessment.

Eligibility Criteria:
Inclusion Criteria:

* Adults will be recruited in this study, all the volunteers participated in this experiment will be healthy looking with free medical history.
* Age range 20-50 years
* High caries risk patients according to ADA caries risk assessment model.
* High plaque index (\>score 2)
* Non-smoking patients.
* Patients with normal salivary rate (0.3-0.4 ml/min).

Exclusion Criteria:

* Patients with a compromised medical history.
* Participants with low caries risk.
* Patients with severe or active periodontal disease.
* Participants with a history of allergy to any of the drugs or chemicals used in the study.
* Patients on any antibiotics during the past month
* Smoking patients.
* Patients with abnormal salivary rate.
* Pregnant female patients
Comparison of Medifast's 5 & 1 Plan to a Food-based Plan of Equal Calories

Portion-controlled meal replacements have been shown to be an effective weight control strategy in overweight and obese individuals. Thus, the investigators plan to evaluate the effect of Medifast's 5 \& 1 program compared to an food-based diet plan of equal calories on the following indices: weight loss and maintenance of weight loss, satiety during weight loss, changes in biochemical markers of inflammation and oxidative stress following weight loss, and compliance and retention rates.


Eligibility Criteria:
Inclusion Criteria:

* Adult males and females (age between 18 and 65)
* Obese (BMI \>=30.0 kg/m2 and \<50.0 kg/m2)
* Non-smokers
* No known food allergies to wheat, gluten, soy or nuts
* \<14 alcoholic beverages per week
* Willing and able to give informed consent
* Not currently using appetite-affecting medications (e.g SSRIs, steroids, Ritalin)
* Not pregnant or lactating
* Primary care physician's permission for weight loss, normal labs and electrocardiogram (EKG) within past 1 year

Exclusion Criteria:

* Actively dieting
* Eating Attitudes Test (EAT) \> 30
* Chronic uncontrolled health problems (not including obesity or diabetes)
* Pacemaker or other internal electronic medical device
* Schizophrenia, history of bipolar disorder, current Major Depressive Disorder
* Dependence on alcohol or sedative-hypnotic drugs (e.g. benzodiazepines)
* Cognitive impairment severe enough to preclude informed consent
* Taking weight loss or appetite-suppressant medications
* Taking appetite affecting medications (e.g. SSRIs, steroids, Ritalin)
* Food allergies to wheat, gluten, soy, or nuts
* Pregnant or lactating
Purified CD34+ Cells Versus Peripheral Blood Mononuclear Cells in Treatment of Critical Limb Ischemia

To compare the efficacy and cost-effectiveness between purified CD34+ cells and peripheral blood mononuclear cells in treatment of critical limb ischemia


Eligibility Criteria:
Inclusion Criteria:

* Rutherford scale of 4-5
* thromboangiitis obliterans, peripheral arterial disease, or arteritis caused by other etiologies, such as collagen diseases
* surgical or endovascular procedures are considered unlikely to have successful long-term revascularization, or have failed
* more than 4 weeks of critical limb ischemia
* if present, a non-healing ulcer after more than 4 weeks of optimal care by a wound care physician and a nurse

Exclusion Criteria:

* within 3 months of an acute myocardial infarction
* any contraindication for the administration of granulocyte colony stimulating factor (G-CSF)
Prospective Database for Prediction of Atrial Fibrillation in Pacemaker and ICD Patients

Atrial fibrillation (AF) is associated with a five-fold increased risk of cerebrovascular stroke. While the risk of stroke in patients with known AF can be calculated via AF stroke prediction risk scores, the prediction of AF occurrence per se in individual patients remains difficult.

We will recruit 250 patients with an implanted dual-chamber Pacemaker (PM) or an implantable cardioverter Defibrillator (ICD) with atrial lead to ensure continuous rhythm monitoring during follow up. At baseline, we will gather clinical and device data of patients. For AF prediction based on surface Electrocardiography (ECG), 24-h Holter ECG monitoring will be performed. After 6 months, we will assess the occurrence of AF during the study period via interrogation of PM/ICD. The resulting data will be used to develop algorithms including clinical, device and ECG data for prediction of the development of AF in individual patients. If possible, we will develop a risk score of high accuracy by combination of demographical, clinical and technical parameters of device patients. The resulting risk score could potentially help to facilitate the decision if anticoagulation is necessary in patients with either risk of AF or embolic stroke of unknown origin. Furthermore, Hayn et al. (AIT Austrian Institute of Technology) are currently developing algorithms to predict the occurrence of AF surface ECG data. It is an additional aim of this project to support the development of this algorithm in pacemaker and ICD patients and to increase the accuracy of AF prediction with clinical parameters and other parameters available to patients with implanted pacemaker (PM) or implanted cardioverter-defibrillator (ICD).


Eligibility Criteria:
Inclusion Criteria:

* Implanted pacemaker or implanted cardioverter defibrillator (ICD) with atrial lead
* CHADS-VASc Score of 2 or more
* Sinus rhythm or atrial paced rhythm
* Atrial stimulation rate 50% or less
* ModeSwitch rate 50% or less since last pacemaker interrogation

Exclusion Criteria:

* pacemaker or ICD malfunction
* atrial fibrillation (AF) at time of pacemaker / ICD interrogation
* AF during 24-hour Holter ECG monitoring
* permanent AF
Preoperative Prophylactic Antibiotic Duration in Moderate to High Risk Ureteroscopy

The goal of this non-inferiority randomized controlled trial: is to test the hypothesis that the that there is no additional benefit from a longer course (7 days) versus a shorter course (2 days) of pre-operative antibiotics in patients with moderate to high risk of infection undergoing ureteroscopy. The main questions it aims to answer are:

1. Determine the safety and efficacy of a short course (2 days) as compared to a long course (7 days)
2. Identify secondary predictors of post-operative infectious complications

Post-operative infectious complications including urinary tract infection (UTI), systemic inflammatory response syndrome (SIRS), and sepsis are uncommon but potentially devastating complications after ureteroscopy. The clinical guidance from the American Urologic Association (AUA) and the European Association of Urology (EAU) is to provide treatment for symptomatic urinary tract infections however the management for asymptomatic patients with positive cultures or those patients who are otherwise at high risk of urinary tract colonization is unclear. As a result, there is significant practice variation in pre-operative prophylactic antibiotic prescription, even amongst fellowship trained endourologists, with some providers prescribing over ten days of pre-operative antibiotics while others offer none. This is a critical gap in our understanding of pre-operative prophylactic antibiotic utilization in a population of patients not only at higher risk of harboring multi-drug resistant (MDR) organisms but are also more susceptible to deleterious outcomes due to their frailty. Recent randomized trials have demonstrated that short courses of pre-operative antibiotics are no less protective than long courses in patients undergoing percutaneous nephrolithotomy (PCNL) for stone removal. Ureteroscopy is the most commonly performed stone surgery worldwide. Establishing an evidence-based approach for antibiotic prophylaxis in the ureteroscopic surgical patient population will be impactful for a large number of patients. The goal of this study is to implement a well-designed randomized clinical trial to establish the standardized antibiotic protocol necessary to minimize unnecessary antibiotic use which may otherwise lead to adverse reactions and proliferation of multi-drug resistant organisms.

Eligibility Criteria:
Inclusion Criteria:

* age (greater than or equal to 18 years)
* indwelling ureteral stent in place
* nephrostomy tube in place
* indwelling foley catheter, suprapubic catheter or clean intermittent catheterization
* asymptomatic bacteriuria
* bowel interposition (such as ileal conduit, neobladder)
* immunosuppression (such as for transplant recipients, active chemotherapy use)

Exclusion Criteria:

* pregnancy
* active infection
* received antibiotics within 7 days preceding surgery that were not prescribed for the study
Throwing Velocity and Patient Reported Outcomes in Elite Level Handball Players After Completion of Shoulder-Pacemaker Strength Training

The successful application of treatment protocols using motion-triggered neuromuscular electrical stimulation (NMES) for treatment-resistant functional posterior shoulder instability was recently demonstrated. The purpose of this study is to evaluate the concept of a motion-triggered NMES training protocol through objective clinical outcome parameters and its impact on external rotational (ER) shoulder strength and throwing velocity in healthy, elite-level handball players.

The aim of this study is to evaluate the concept of a motion-triggered NMES training protocol through objective clinical outcome parameters and its impact on external rotational (ER) shoulder strength and throwing velocity in healthy, elite-level handball players. It is hypothesized that a 6-week motion-triggered NMES shoulder strengthening training protocol in elite-level handball players would lead to an increase in throwing velocity due to an improved motor ability and ER shoulder strength.

Eligibility Criteria:
Inclusion Criteria:

* Elite level handball players healthy and actively competing at the time of the study
* Patients must be at least 18 years at the time of signing the informed consent
* Pregnancy must be ruled out in the case of female participants (e.g., pregnancy test)
* Patient must be available for all specified assessments throughout the study duration
* All patients are required to give written informed consent before enrollment

Exclusion Criteria:

* age \&lt;18,
* history of type I or II shoulder instability according to the Stanmore classification12,
* existing pain syndrome (defined by pain at rest or during motion that is not caused by dislocation and impedes training),
* recent shoulder surgery (\&lt;1 year).
* Contraindication to SPM treatment (e.g., cardiac pacemaker)
* Neurological disorders or nerve injuries causing the instability
* Uncontrolled alcohol or substance abuse