cyrilzakka/clinical-trials huggingface dataset:
Thulium Fiber Laser Prospective Trial

This is a multi-center, prospective clinical trial to assess the effect of TFL for the lithotripsy of kidney stones.

Flexible ureteroscopy is considered the first-line therapy for renal stones \< 2 cm. The Holmium: YAG laser (Ho:YAG) is established as gold standard in urology practice. Despite its limitations, it is widely used to break stones into fragments small enough to remove or pass spontaneously through the ureter. Advances in the understanding of laser energy delivery have led to the recent commercialization of the 'Thulium Fiber Laser' (TFL) with unique characteristics and promising improvements of ablation efficiency, dusting capacity, operating time and deflection. A a multi-center, prospective clinical trial to further assess those advantages for the lithotripsy of kidney stones will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Solitary renal stone 8 to 20 mm in size or in the case of multiple stones the conglomerate diameter of 8-20 mm is required
* Must be a suitable operative candidate for flexible ureteroscopy per urologic guidelines
* Must be 18 years or older
* Must be able to give consent
* Bilateral ureteroscopy will be permitted but only the first side will be included in the study

Exclusion Criteria:

* Concomitant stones in the ureter
* Prior ipsilateral upper urinary tract reconstructive procedures or history of ipsilateral ureteral stricture
* Prior radiotherapy to the abdomen or pelvis
* Neurogenic bladder or spinal cord injury
* Pregnancy
* Untreated Urinary Tract Infection (UTI)
Effects of Microcrystalline Titanium Dioxide With Covalently Linked Monovalent Silver Ions on Complications After Total Hysterectomy

Total hysterectomy is one of the most performed surgical procedures in the world and it is associated with post-operative complications. The postoperative morbidity rate is estimated to vary from 3% to 8% with a readmission rate of 5-7%. The most frequent postoperative complications are urinary tract infections, wound infection of the vaginal vault, vault cellulitis, bleeding, suture dehiscence, pelvic abscess. The introduction of routine antibiotic prophylaxis has significantly reduced the risk of infectious complications, which however remains higher than other "clean" surgery, mainly due to contamination by the vaginal bacterial flora. In this scenario, the introduction of adjuvant factors acting on bacterial flora, can contribute to reduce the risk of post-surgical complications.

The cationic silver ions (Ag +) stabilized by covalent link with Titanium dioxide (TiO2), the TIAB, maximizes the properties of silver by optimizing the antibiotic action and disruptive properties of the pathogenic biofilm of bacteria and fungi. Thanks to these properties, TIAB is able to enhance the antibiotic action by reducing the risk of antibiotic resistance and recurrent infections linked to the biofilm. Re-establishing the optimal vaginal microenvironment represents a fundamental step reducing the risk of infections in the surgical site, since the vagina is a non-sterile environment populated by bacterial species that can generate biofilm and potentially infect the site of surgery. In addition to microbicidal and disruptive biofilm activity, TIAB has demonstrated a direct action on tissue regeneration processes by stimulating the production of collagen and its modeling.

Different clinical trials have reported a cicatrizing and re-epithelializing action of TIAB administered vaginally in the context of cervical conization for pathology related to HPV. Without showing any notable adverse effects or a negative action on lactobacillary flora with an overall good therapy tolerance by patients.

On the basis of the available evidence, we conduct a randomized controlled clinical trial to determine if TIAB treatment in the formulation of vaginal capsules TIAGIN (TIAB (microcrystalline titanium dioxide with covalently linked monovalent silver ions), Sodium Hyaluronate, Aloe Barbadensis Extract) is able to reduce the incidence of infectious complications, that are related to altered healing of post-hysterectomy vaginal suture.


Eligibility Criteria:
Inclusion Criteria:

* Women underwent laparoscopic total hysterectomy for benign gynecological pathology

Exclusion Criteria:

* Women underwent non-laparoscopic total hysterectomy
* Women underwent laparoscopic total hysterectomy for malignant pathology
* Patients with diabetes mellitus in insulin therapy
* Smoking patients
* Patients suffering from chronic rheumatic diseases or chronic diseases not in adequate control.
Measures of Mitochondria Dysfunction in PD

This study evaluates metabolic and functional parameters in the skeletal muscle of Parkinson's disease patients for comparison to a set of healthy age-matched controls.

The goal of this study is to identify the unique signature of bioenergetic markers and mitochondrial (dys)function in muscle of individuals with PD, who are 65-85 of age, read and speak English, have a Hoehn \& Yahr score between 2 and 3 (bilateral disease, not severely disabled) and have a clinical diagnosis of PD. Bioenergetic markers and muscle functional properties will be compared to a control dataset collected over the last few years from healthy elderly subjects in the same age range to provide a foundation for future intervention studies.

Eligibility Criteria:
Inclusion Criteria:

* Age 65-85 years.
* Ability to attend a 3-hour study visit in Seattle, WA.
* Ability to read and speak English.
* Hoehn \& Yahr Stage 2-3. (bilateral disease, not severely disabled.)

Exclusion Criteria:

* Any contra-indication to magnetic resonance imaging
* A history of epilepsy, stroke, brain surgery, or structural brain disease.
* The presence of other serious illnesses
* Current or recent enrollment in a clinical trial involving an investigational product or device.
* Supplementation with NAD, nicotinamide mononucleotide (NMN), nicotinamide riboside (NR), and other nutraceuticals designed to target NAD for 30 days prior to baseline study visit.
* Current drug or alcohol use or dependence.
* Inability/unwillingness to provide informed consent. (e.g. diagnosis of dementia, confusion about study goals or participation.)
* Acute infection (e.g. upper respiratory, dermal) in the previous 30 days.
* Right limb tremor or dyskinesia that cannot be comfortably controlled for 90 minutes.
Calcium Electroporation in Patients With Cell Changes in the Esophagus

The aim of this first-in-man study is to evaluate the safety of calcium electroporation used in patients with Barrett's esophagus high-grade dysplasia through an endoscopic system.

After being informed about the study and potential risks, all patients give written informed consent. Thereafter, patient will get calcium electroporation with biopsies and digital photographs on day 0. We expect to discharge all patients same evening. Between day 3-7 an examination is followed by gastroscopy with biopsies and digital photographs. On day 14 the patients are followed in our outpatient clinic. 6 weeks after treatment the patients will undergo endoscopic mucosa resection (EMR) or endoscopic submucosa dissection (ESD) surgery and thereby the standard care of treatment for Barrett's esophagus high-grade dysplasia.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥18 years old.
2. Histological verified Barrett's esophagus high-grade dysplasia (BE HGD)
3. Expected survival \> 3 months.
4. Performance status Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) ≤ 2.
5. Platelets ≥ 50 billion/l, International Normalized Ratio (INR) \< 1.5. Medical correction is allowed, e.g. correction of a high International Normalized Ratio (INR) using vitamin K.
6. Subjects must be willing and able to comply with the procedure, such as agreed follow-up visits.
7. Sexually active men and fertile women must use adequate contraception during this trial
8. Subjects must give written informed consent.

Exclusion Criteria:

1. Coagulation disorder that cannot be corrected.
2. Subjects with a clinically significant cardiac arrhythmia.
3. Concurrent treatment with an investigational medicinal product
4. Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements.
5. Pregnancy or lactation

A medical doctor will always be responsible for final inclusion of the subject.
Nutrition Education and e-Texting to Increase Access to Fresh Produce

The proposed project, Nutrition Ed, Access and Texting (NEAT): Combining the Hartford Mobile Market with e-Marketing , uses an e-technology social marketing strategy to promote use of a recently launched mobile produce market among SNAP-Ed recipients. This study will potentially increase fresh produce access and intake by combining an innovative food system change (produce mobile market) with existing SNAP-Ed nutrition education curriculum and the use of e-marketing technology.

The proposed project, Nutrition Ed, Access and Texting (NEAT): Combining the Hartford Mobile Market with e-Marketing uses an e-technology social marketing strategy to promote use of a recently launched mobile produce market among SNAP-Ed recipients. This study will potentially increase fresh produce access and intake by combining an innovative food system change (produce mobile market) with existing SNAP-Ed nutrition education curriculum and the use of e-marketing technology. Thus, the study combines key elements that have been deemed necessary for increasing produce intake among low income communities. The goal of the NEAT study is to assess the impact of a texting-based social marketing campaign on SNAP-Ed participants' access to and purchase of fresh produce on a recently launched mobile produce market, and their subsequent produce intake. Objectives include: 1) Compare the impact of nutrition education alone to nutrition education plus promotional text messaging on purchase of fruits and vegetables; 2) Compare the impact of nutrition education alone to nutrition education plus promotional text messaging on consumption of fruits and vegetables; and 3) Assess the effectiveness of coupon distribution on coupon redemption at a mobile produce market. The NEAT design will be a randomized controlled trial using a pre-post assessment comparing change in behavior. Both intervention and control groups will receive SNAP-Ed education as currently delivered by the Hispanic Health Council. The intervention group will receive additional promotional text messaging related to use of the mobile market. The control group will receive text messaging about free activities taking place at the Hartford Public Library and other community locations. Participants will be interviewed via phone at baseline, then randomized to intervention and control groups, and re-interviewed again 6 weeks after they start receiving the text messages, which it will be 2 weeks after the one-month texting period ends.

Eligibility Criteria:
Inclusion Criteria:

* SNAP eligible participants with children under 5 years old living at home.
* Living in Hartford, CT.
* Having a cell phone with unlimited smart phone data plans.

Exclusion Criteria:

* Not living in Hartford Less than 18 years old
The Effect of Total Intravenous Anesthesia and Volatile Anesthesia on Shedding of the Endothelial Glycocalyx in Patients Undergoing Laparoscopic or Robotic Assisted Gastrectomy

The aim of this study was to investigate the effects of total intravenous and inhalation anesthesia on the damage of endothelial glucocorticoids by comparing the concentration of syndecan-1 before and after laparoscopic or robotic assisted gastrectomy.

A commercial TIVA(Total Intravenous Anesthesia and Volatile Anesthesia ) pump was used for target-controlled infusion (TCI) of remifentanil and propofol. In the volatile group, anesthesia was induced with an intravenous bolus of propofol 1.5-2 mg/kg and TCI of remifentanil (effect-site concentration \[Ce\] of 4.0 ng/ml). In the TIVA group, anesthesia was induced with TCI of propofol (Ce of 4.0-4.5 μg/ml) and remifentanil (Ce of 4.0 ng/ml). In the volatile group, anesthesia was maintained with sevoflurane (0.8-1 age-adjusted minimum alveolar concentration \[MAC\]) and TCI of remifentanil, while in the TIVA group, anesthesia was maintained with TCI of propofol and remifentanil. Anesthesia depth was adjusted to maintain a PSI(Patient State Index) of 25-50. Endotracheal intubation was performed after administration of intravenous rocuronium 1.2 mg/kg and neuromuscular blockade depth was maintained to a target of train-of-four of 0-2 with infusion of rocuronium during pneumoperitoneum.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients over 20 years old with ASA class I-III
2. Scheduled laparoscopic or robotic assisted laparoscopic gastrectomy

Exclusion Criteria:

1. emergency surgery
2. patients unable to make their own decisions, illiterate, foreigners
3. Allergy / hypersensitivity to sevoflurane or propofol 4, Current or past history or thrombosis / thromboembolism

5. patients who are taking oral contraceptives 6. Patients with renal insufficiency (eGFR 60 ml / min / 1.73 m 2 or less) 7. Patients receiving anticoagulants 8. pregnant and lactating women 9. Patients with history of psychiatric disease or neurological disease
DOAC ADRs Retrospective Study

This retrospective study's objective is to evaluate if Cipherome's algorithm could have predicted the serious adverse drug reactions (ADRs) experienced by patients while on direct oral anti-coagulants (DOACs).

Using the latest next generation sequencing tools, this study will evaluate adverse drug reactions (ADRs) (e.g., major bleeding or treatment failure) in study participants while on direct oral anticoagulants (DOACs). A web-based program will analyze the data obtain from sequencing, and generate a drug safety score (DSS). The DSS risk score will be compared with pre-specified serious ADRs associated with DOAC therapy. A secondary analysis will involve discovery of novel variants that arise from our analysis and may potentially affect the outcome of DOAC treatment.

Eligibility Criteria:
Inclusion Criteria:

* Any adult patient 18 years and older, who experienced a serious adverse drug reaction while taking a DOAC and is able to provide informed consent.

Exclusion Criteria:

* Failure to provide informed consent
Safety and Feasibility of the NeurolyserXR for Sacroiliac Joint Pain

Pilot study to evaluate the safety and the effectiveness of the Neurolyser XR as a treatment for sacroiliitis

Pilot, Interventional, Prospective, Open label, Single Arm study to evaluate Non-invasive thermal ablation of the posterior sacral nerve branches as a treatment of painful sacroiliac joint (SIJ) using High Intensity Focused Ultrasound delivered by the Neurolyser XR.

Patient would be treated and then followed for up to 6 months. Primary safety endpoint will be measured by the incidence and severity of treatment related adverse events Primary effectiveness endpoint will be measured by the changes in average pain score and Rolland Morris Disability Questionnaire between baseline and 6 and 12 months

Eligibility Criteria:
Inclusion Criteria:

1. Adult male and females, legally able and willing to participate in the study and come for follow-up visits
2. Able and willing to fill the research questionnaires and to communicate with investigator and research team
3. Patient with bilateral or unilateral sacroiliac joint pain of \> 6 months duration
4. Patients presenting with a) a positive (\>70% pain relief) to a previous nerve ablation procedure of the sacroiliac joint and / or b) with a positive (\>70% pain relief) to a previous nerve block procedure of the sacroiliac joint within the last six months)
5. Average pain score of 4 or higher in the last month, (on 0-10 scale).

Exclusion Criteria:

1. Pregnant or breastfeeding patient
2. Patients younger than 18 or older than 80 years
3. Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain).
4. Patients with history of lumbar and / or sacral spine surgery
5. Patients with the presence of metal hardware at the lumbosacral spine
6. Patients with history of pelvic pathology that may increase procedural risk and / or influence symptoms and / or generate unrelated adverse event (per the discretion of the study PI)
7. Patients unable to understand and complete the research questionnaires in Hebrew.
8. Patients presenting with any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome.
9. Patient with extensive scarring in the skin and tissue overlying the treatment area.
10. Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project
Attentional Bias Modification Training for E-cigarette Users

Aims are to (1) evaluate attentional bias to e-cigarette cues between the intervention and control groups at post-intervention as compared to the pre-intervention; and (2) test the feasibility and efficacy of the intervention at post-intervention. To accomplish these aims, a theory-driven parallel, controlled 2-arm randomized clinical trial will be conducted with young adult e-cigarette users (approximately N = 50). Outcomes are attentional bias to e-cigarette cues and abstinence outcomes including nicotine dependence, and arousal/urges for e-cigarette use.


Eligibility Criteria:
Inclusion Criteria:

* 18 and 29 years
* Those who use ENDS exclusively, not combining with other tobacco, for 3 consecutive months
* Those who own a smartphone.

Exclusion criteria:

* Current medication or psychosocial treatment for ENDS dependence
* Serious alcohol-use problems (≥ 26 points on the Alcohol Use Disorders Identification Test)
* Ophthalmic conditions impeding eye-tracking
* Current psychiatric/psychosocial treatment for other mental health disorders in the DSM-5 (e.g., schizophrenia)
* Pregnancy.
A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults

The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.

The primary goal of this Phase III study is to compare three lots for consistency of manufacture.

Eligibility Criteria:
Inclusion Criteria:

* healthy men or women,
* age 18 to 45 years inclusive;
* normal medical history and physical examination
* Women must have a negative pregnancy test.

Exclusion Criteria:

* travel to a cholera endemic area in the previous 5 years;
* abnormal stool pattern or regular use of laxatives;
* Currently active unstable or undiagnosed medical conditions
* current or recent antibiotic use;
* pregnancy or nursing;
* Previously received a licensed or investigational cholera vaccine
* History of cholera or enterotoxigenic E. coli infection
* History of Guillain-Barré Syndrome
* Received or plans to receive any other licensed vaccines, except for seasonal influenza
* Recipient of bone marrow or solid organ transplant
* Malignancy (excluding non-melanotic skin cancers) or lymphoproliferative disorders diagnosed or treated during the past 5 years
* Use of systemic chemotherapy in the previous 5 years prior to the study
* any immunosuppressive medical condition
Nebulized vs. Oral Midazolam Sedation in Pediatric Anesthesia: A Randomized Comparative Study

This study is to be carried out to compare nebulized and oral midazolam in achievement of a satisfactory level of sedation, Ramsey Sedation Score (RSS) of 4, within 30 mins of midazolam administration in pediatrics.

This study is to be carried out to compare nebulized midazolam and oral midazolam in achievement of a satisfactory level of sedation, Ramsey Sedation Score (RSS) of 4, within 30 mins of midazolam administration in pediatric surgical patients.

In Pediatric Specialized Hospital, Cairo University 72 pediatric patients scheduled for undergoing general or uro-surgical operations under general anesthesia will be included in this double-blinded study. Patients will be randomly assigned into two equal groups, each group including 36 patients. In one group 36 children will receive nebulized midazolam 0.2 mg/kg in 3 ml normal saline plus 5 ml clear juice (orally) 30 min before undergoing general anesthesia. In the other group 36 children will receive oral midazolam 0.5 mg/kg in 5 ml clear juice plus nebulizer of 3 ml normal saline 30 min before undergoing GA.

level of sedation will be compared between both groups

Eligibility Criteria:
Inclusion Criteria:

* Patients from 2 to 6 years undergoing uro-surgery and general surgical procedures.
* Duration of surgery 1-2 hours
* Gender eligible for the study: both.
* ASA I-II.

Exclusion Criteria:

* ASA III-IV
* Patients with elevated levels of serum ALT, Creatinine.
* Emergency surgeries.
* Pre-existing neurologic disease.
* Parent refusal.
* History of allergy to midazolam.
* Patients with atopy or a history of asthma.
* Lengthy procedures of more than 2 hours
Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure Therapy™ in Diabetic Foot Ulcers

To determine if topical negative pressure therapy delivered by the V.A.C.® device is clinically efficacious and cost effective in the treatment of diabetic foot ulcers.

The purpose of this study is to compare the effectiveness of V.A.C.® Therapy to moist wound therapy of diabetic foot ulcers. The primary objective is to determine the effect of V.A.C.® Therapy on the incidence of complete wound closure.


Eligibility Criteria:
Inclusion Criteria:

* Presence of a calcaneal, dorsal or plantar diabetic foot ulcer ≥ 2 cm2 in area after debridement. (If more than one ulcer is present, all wounds will be treated using the same method, but only one ulcer will be studied.)
* DFU equivalent to Stage 2 or greater, as defined by Wagner's Scale system (See Appendix E)
* Evidence of adequate perfusion by one of the following on the affected extremity,(within the past 60 days):Dorsum transcutaneous oxygen test (TcPO2) with results of ≥30 mmHg, or ABIs with results of ≥0.7 and ≤1.2 and toe pressures with results of ≥30 mmHg, or Doppler arterial waveforms, which are triphasic or biphasic at the ankle in the affected leg.
* Age ≥ 18 years of age
* HbA1c ≤ 12% (collected within the last 90 days.)
* Evidence of adequate nutrition by one of the following:
* Lab results reflecting Pre-Albumin \>16 mg/dl and Albumin level is \>3 g/dl (during the seven days prior to the study period), or a nutritional consult will be done and with appropriate supplementation started. Proper documentation on CRFs is needed.

Exclusion Criteria:

* Patients with recognized active Charcot abnormalities of the foot, as evidence by clinical symptoms that interfere with either randomized treatment group
* Ulcers resulting from electrical, chemical, or radiation burns, or venous insufficiency
* Untreated infection or cellulites at site of target ulcer
* Presence of untreated osteomyelitis
* Collagen vascular disease
* Malignancy in the ulcer
* Presence of necrotic tissue
* Uncontrolled hyperglycemia
* Concomitant medications that include (washout period of 30 days for corticosteroids, immunosuppressive medications, or chemotherapy)
* Open amputations
* Prior V.A.C. therapy within 30 days.
* Current or prior normothermic (Warm-UP®) or HBO therapy within 30 days.
* Current or prior treatment with recombinant or autologous growth factor products within the past 30 days. (Examples: Regranex or Procuren)
* Current or prior treatment with skin or dermal substitutes and dressings (Examples: Apligraft, Dermagraft, or Integra) with living cells capable of producing growth factors (Example: Oasis) within the past 30 days.
* Current use of any enzymatic debridment agent (Example: Acuzyme /Panafil) during the active treatment phase of the study
* Pregnant or nursing mothers.