cyrilzakka/clinical-trials huggingface dataset:
A Comparison of the Ambu AuraGain Versus LMA Supreme in Children

The purpose of this study is to determine whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain and the Laryngeal Mask Airway (LMA) Supreme.

The goal of this prospective randomized study is to compare whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain (sizes 1.5 and 2) and the Laryngeal Mask Airway (LMA) Supreme. Parameters of clinical relevance such as insertion success rates, fiberoptic view of the glottic opening, ease and speed of gastric tube placement, airway stability, and peri-operative complications will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for surgery utilizing a supraglottic airway device
* ASA (American Society of Anesthesiologists) I-III classification
* Weighing between 5 - 20 kilograms

Exclusion Criteria:

* Active respiratory infection
* History of difficult mask ventilation
* Diagnosis of congenital syndrome with difficult airway management
* Active gastrointestinal reflux
* Coagulopathy
* Significant Pulmonary disease
* Emergent surgery
Best Surgical Technique for Optimal Lead Placement in Sacral Neuromodulation - a Comparative Cadaver Study

Sacral neuromodulation (SNM) is an established treatment option for patients with faecal incontinence. The location of the stimulating electrode is considered to be essential for treatment success. The purpose of this study was to evaluate the position of SNM electrodes after using the conventional implantation technique and to compare our results with those of the preliminary study, where the standardised fluoroscopy-guided implantation technique was used.

In this cadaver study, SNM electrodes will be implanted bilaterally in 5 lower body specimens. After electrode placement the pelvis was dissected to describe the exact position of the SNM electrodes.

Sacral neuromodulation (SNM) is an established treatment option for patients with faecal incontinence. The location of the stimulating electrode is considered to be essential for treatment success. The purpose of this study was to evaluate the position of SNM electrodes after using the conventional implantation technique and to compare our results with those of the preliminary study, where the standardised fluoroscopy-guided implantation technique was used.

However, to date no studies exist comparing different surgical techniques. The present cadaver study was designed to assess the distance between lead and sacral nerves by comparing two different surgical techniques: the new fluoroscopy guided "H" technique and the commonly conducted non radiological lead implantation using anatomical landmarks.

In this cadaver study, SNM electrodes will be implanted bilaterally in 5 lower body specimens.Afterwards the cadaver will be dissected and the exact location to the nerve, as well as a perforation of the sacral fascia will be noted.

The results will be compared to the preliminary study of Mueller et al., where they used the new fluoroscopy guided "H" technique in five cadavers.

Eligibility Criteria:
Inclusion Criteria:

* Cadaver study
* All of these individuals had donated their bodies to medical education and research in form of an informed consent.

Exclusion Criteria:

* none
Validation and Testing of a Novel Continuous Glucose and Continuous Ketone Monitoring Device in Healthy Volunteers

Diabetic ketoacidosis (DKA) is a severe complication of type 1 diabetes (T1D) that can have life-threatening consequences. It occurs when there is a high level of glucose in the blood and the body produces excessive amounts of ketone bodies. To manage this condition, individuals with T1D need to constantly monitor their levels of ketone bodies and glucose. While continuous glucose monitoring (CGM) devices have made significant advancements in providing non-invasive or minimally invasive glucose measurements, there has been little progress in developing methods for continuous monitoring of ketone bodies (CKM). Currently, the commonly used approaches involve self monitoring with commercially available blood or urine strips. However, these tools have limited adoption, provide only single time point measurements, and can be costly for some patients.

In our project, which is funded by Breakthrough T1D (2-SRA-2022-1167-M-B), we address this challenge by utilizing a minimally invasive biosensor based on hydrogel microneedle (HMN). This biosensor enables simultaneous and continuous measurement of the primary biomarker for ketone formation, 3-β hydroxybutyrate (β-HB), as well as glucose levels. By doing so, we intend to reduce the risk of diabetic ketoacidosis in patients with T1D. We plan to test the developed CGM-CKM device on human subjects, including both healthy volunteers (HV) and patients with T1D. The HV testing will take place at the laboratory of Dr. Poudineh and Dr. Devries-Aboud in Waterloo, while the validation involving patients with T1D will be conducted in collaboration with Dr. Lal at Stanford.


Eligibility Criteria:
The age range for the healthy volunteers (HVs) will be between 18 and 45 years old and with no family history of Diabetes (T1D or T2D, specifically biological parents and siblings).

Exclusion criteria included: (i) currently taking any medications (except for birth control for females); (ii) following a low-carbohydrate diet or consuming nutritional ketone supplements; (iii) considered competitive athlete engaged in competition or intensive training, (iv) have been diagnosed with Diabetes (T1D or T2D), hypertension, cardiovascular disease, kidney disease, and thyroid disorder. (v) Having an allergy to any of the ingredients in the products used in the study, which will be explained to you in detail.
Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Rituximab Pateinets With Aggresive NHL

We now propose to investigate the combination of CHOP-Rituxan plus PEG-Filgrastim (PEG-filgrastim) and GM-CSF. PEG-Filgrastim would be given in order to allow us to administer the chemotherapy courses every 2 weeks with the practical advantage of requiring only one dose of PEG-filgrastim instead of daily doses of G-CSF.

1.1 Primary Objective:

1. To identify the ideal dose of the combination of CHOP-R with PEG-Filgrastim (Neulasta) using first a fixed dose of Neulasta and an escalating dose of GM-CSF (Leukine) up to 250 mcg. When that dose is reached, if possible, the dose of Neulasta will be increased stepwise. CHOP-R will be delivered every 14 days at a fixed standard dose with dose adjustments of PEG-Filgrastim and GM-CSF upwards and downwards according to nadir or zenith blood counts.

   1.2 Secondary Objective:
2. To generate preliminary pilot data as to the effectiveness of the regimen in inducing very early remissions as measured by the CT-PET scan technique.

Eligibility Criteria:
Inclusion Criteria:

* Patients with previously untreated aggressive non-Hodgkin's Lymphoma. Aggressive histologies include follicular large cell, diffuse large cell, peripheral T cell, transformed lymphomas, Lymphoblastic lymphomas, Burkitt and Burkitt like lymphomas.
* Must have measurable or evaluable disease.
* Stage I-IV patients are eligible
* Patients must be 18 years or older.
* No evidence of grade 3 or more neurosensory or neuromotor dysfunction (see appendix- toxicity criteria)
* Written Consent

Exclusion Criteria:

* HIV positive patients and those with Hepatitis B or C will be excluded from this protocol.
* Patients with inadequate bone marrow and organ function as defined below:
* Neutrophils \<1,000/l
* Platelets \<100,000/l
* Billirubin \>2
* Creatinine \>2.0 or estimated CrCl \<30 cc/min
* CNS involvement by Lymphoma.
* Uncontrolled intercurrent disease including arrhythmias, angina pectoris, Class III-IV Congestive heart failure (CHF symptoms on less than ordinary exertion or at rest) or active infection.
* Active infection or fever \> 38.2 degrees C unless due to lymphoma.
* Subject is not using adequate contraceptive precautions.
* Pregnancy or breast feeding
Erythrocyte Complement Receptor 1 and Alzheimer Disease

Main objective: investigate whether a functional polymorphism of CR1 (length, number of binding sites in C4b C3b, erythrocyte density, rate of soluble CR1 ...) so determined genetic or acquired, is a susceptibility factor for the disease Alzheimer's.


Eligibility Criteria:
Inclusion Criteria:

* caucasians people with a Alzheimer dementia defined on DSMIV criteria for patients and without Alzheimer disease for control subjects

Exclusion Criteria:

* diseases modifying CR1 physiology
A Study of the Safety and Effectiveness of Levofloxacin Compared With Lomefloxacin in the Treatment of Complicated Urinary Tract Infections

The purpose of the study is to compare the safety and effectiveness of oral levofloxacin (an antibiotic) with that of oral lomefloxacin in the treatment of complicated urinary tract infections in adults.

Levofloxacin is an antibacterial agent used for the treatment of a broad spectrum of acute infections in adults. This is a randomized, open-label study of the safety and effectiveness of levofloxacin compared with lomefloxacin in the treatment of adults with complicated urinary tract infections. Patients in one group are treated with 250 mg of levofloxacin, taken once daily for 7 to 10 days, and the other group is treated with 400 mg of lomefloxacin, also an antibacterial agent, taken once daily for 14 days. Patients are followed for 5 to 9 days after completion of treatment (post-therapy) to assess clinical signs and symptoms of infection. Long-term follow up (4 to 6 weeks after the end of treatment) of those patients who respond to therapy provides further evaluation of clinical signs and symptoms. The primary assessments of effectiveness include the clinical response (the resolution of signs and symptoms at post-therapy compared with those at the start of study) and the microbiological response (the eradication at post-therapy of the infectious organism identified at the start of study) An additional assessment of efficacy includes the overall clinical response, which is described as cured, improved, or failed. Safety assessments include the incidence of adverse events throughout the study, clinical laboratory tests (hematology, serum chemistry, and urinalysis) and physical examinations at the start of the study and post-therapy. The study hypothesis is that levofloxacin is at least as effective therapeutically as lomefloxacin in the treatment of adults with complicated urinary tract infections. Levofloxacin tablets, an oral dose of 250 mg taken once daily for 7 to 10 days. Lomefloxacin tablets, an oral dose of 400 mg taken once daily for 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a urinary tract infection with complicating factors such as anatomical or functional abnormalities
* capable of taking medication by mouth
* previous antibacterial therapy of less than 24 hours, or previous antibacterial therapy of greater than 24 hours that did not eliminate or stabilize the infection.

Exclusion Criteria:

* Patients having any medical condition that requires antimicrobial therapy to be given intravenously or by hypodermic needle
* complete obstruction of any part of the urinary tract
* previous allergic or serious adverse reaction to similar antibiotics
* inflammation of the prostate gland
* pregnant or nursing females, or those lacking adequate contraception.
Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus

The objective of the study is to investigate the long-term safety and efficacy of BI 10773 given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 2 diabetes mellitus with insufficient glycaemic control.


Eligibility Criteria:
Inclusion criteria:

* .Diagnosis of type 2 diabetes mellitus prior to informed consent
* Male and female patients, on diet and exercise regimen, who are pre-treated with one of the following oral antidiabetic drugs: sulfonylurea, glinide, biguanide, Alpha-glucosidase inhibitor (a-GI), dipeptidyl peptidase-IV (DPP-IV) inhibitor or thiazolidinedione
* glycosylated haemoglobin (HbA1c) at Visit 1: \>=7.0 to =\<10.0% (national glycohemoglobin standardization program)

Exclusion criteria:

* Uncontrolled hyperglycaemia with a glucose level \>240 mg/dL (\>13.3 mmol/L)
* Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent
* Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN)
Pompe Gene Therapy- Screening for Eligibility

The purpose of this study is to determine eligibility for the future clinical trial of gene therapy in adults with late-onset Pompe disease.

This screening protocol will enroll up to 20 adults patients (\>=18 yo) with late-onset Pompe disease. Study assessments include review of medical history, vital signs, physical examination, muscle function testing, lung function testing, blood and urine collection, serum pregnancy test and ECG.

The study results will be collected to perform descriptive statistical analysis and used to determine eligibility for the proposed clinical trial of gene therapy in the future.


Eligibility Criteria:
Inclusion Criteria

* Diagnosis of Pompe disease by blood or skin fibroblast GAA assay and two pathogenic variants in the GAA gene.
* Age: at least 18 years at enrollment.
* Subjects are capable of giving written consent.
* Receiving ERT at a stable dose for at least 104 weeks.

Exclusion Criteria

* Any condition that would interfere with participation in the study as determined by the principal investigator.
* Pregnancy or nursing mothers.
* History of active hepatitis B, hepatitis C, or cirrhosis
* Receiving any investigational agent.
The Effectiveness of Heat Treatment on Knee Pain in Patients with Osteoarthritis - an International, Multicenter Clinical Investigation

This post-market clinical follow-up, open-label, multicenter clinical investigation is designed to investigate the effectiveness, safety and tolerability of ThermaCare® Knee Heatwraps in the painful knee joint due to osteoarthritis. Approximately 80 patients, 19-69 years old inclusive, with moderate knee osteoarthritis (without acute flares or inflammation) will be enrolled. The overall duration of the investigation is expected to be 11 days, including screening days. The maximum treatment duration for each patient is 7 days (8h/d).


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent before inclusion in the investigation.
* Any gender, any ethnic origin, 19-69 years old inclusive.
* Body Mass Index 18.5-40 kg/m2 inclusive.
* Full comprehension: ability to comprehend the full nature and purpose of the clinical investigation.
* Patient with diagnosis of mono or bilateral moderate knee osteoarthritis with knee pain intensity \> 40 mm on a 0-100 mm VAS, able to independently ambulate without walking aid.
* Availability of a radiography of the selected knee not older than 6 months.
* Patient is either not of childbearing potential or must agree not to start a pregnancy from the signature of the informed consent up to the final visit

Exclusion Criteria:

* Clinically significant abnormal physical findings which could interfere with the objectives of the investigation
* History of anaphylaxis to drugs or allergic reactions in general, which could affect the outcome of the clinical investigation.
* Significant history of diseases that may interfere with the aim of the clinical investigation.
* History of (in the last 6 months) or ongoing intra-articular injection involving the selected knee. History of ongoing physical therapy involving the selected knee.
* Presence of flares, inflammation, effusion and swelling at the selected knee.
* Any skin injury, wound, irritation, rash, bump, sore and/or discoloration at the application area.
* Surgery at the selected knee in the 12 months preceding the clinical investigation.
* Any medication that could interfere with the investigation procedures or investigation outcome.
* Use of other hot or cold therapies for the selected knee.
* Positive pregnancy test at screening; pregnant or breastfeeding women
* History of (within the past 12 months) or current drugs or alcohol abuse
* Individuals unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced because of a compromised position, expectation of benefits or fear of retaliatory response.
An Expanded Access Study to Assess Brensocatib for Participants With Non-Cystic Fibrosis Bronchiectasis

The purpose of this study is to allow early access to brensocatib for participants with non-cystic fibrosis bronchiectasis (NCFBE) who have successfully completed the INS1007301 ASPEN Clinical trial.

Participants will receive brensocatib 10 mg, oral tablets, once daily.

Eligibility Criteria:
Inclusion Criteria:

* Participant had agreed to provide their informed consent to participate per local requirements.
* Participant had successfully completed Clinical Trial INS 1007-301 ASPEN, including the End of study Visit 12 prior to receiving treatment.
* Requests for Post-Trial access for brensocatib had come from ASPEN investigator.
* Had received brensocatib treatment.

Exclusion Criteria:

* Participant had experienced a serious adverse event deemed to be related to brensocatib during the study and required permanent participant is continuation.
* The participant is immunocompromised or chronically treated with any investigational or commercialized immunomodulatory agent that is directed to any component of the adaptive or innate immune systems.

Note: The use of any immunomodulatory agents (including but not limited to: bortezomib, ixazomib, thalidomide, cyclophosphamide, mycophenolate, Janus kinase inhibitors, IFN-γ, and azathioprine) is prohibited during the program.

* The participant had undergone continuous use of high dose non-steroidal anti-inflammatory drugs.
* The participant had undergone chronic use of systemic steroids for any chronic condition, except steroids with topical anti-inflammatory activities (ie, oral budesonide).
* Participant had planned to receive live attenuated vaccines during the program (treatment must be postponed until 4 weeks after the last dose of drug).
* Participant had planned to use investigational drugs.
Postoperative Morbidity and Mortality After Gastric Cancer Surgery

Gastric cancer is still one of the main health care issue and gastrectomy with lymph node dissection is the only chance to be cure. Trials show that the postoperative course differs significantly between eastern and western centers, as well as between clinics within Russian Federation. Postoperative 30-day postoperative mortality after gastric cancer surgery ranges from 1% to 5%, and postoperative complication rates range from 10% to 40%. To improve the quality of further studies and recommendations for standardization of surgical treatment of gastric cancer and its complications, there is a need to study the differences in 90-day postoperative morbidity and mortality in different clinics and centers of the Russian Federation.

According to 2018 World Health Organization (WHO) data, gastric cancer is the fourth most common malignant disease and the third leading cause of cancer-related deaths worldwide. Surgery with lymphadenectomy remains the standard of care. Despite significant changes in gastric cancer treatment protocols, surgery is still associated with high risks of complications, with rates varying from clinic to clinic. And currently, the use of multimodal treatments and standardization of surgical procedures are proposed as strategies to improve outcomes. In addition, the use of laparoscopic and robotic techniques have been proposed to provide better short-term results compared to open surgery and comparable long-term oncological outcomes. Randomized trials show that the postoperative course differs significantly between eastern and western centers, as well as between clinics within Russian Federation. Postoperative 30-day postoperative mortality after gastric cancer surgery ranges from 1% to 5%, and postoperative complication rates range from 10% to 40%. While mortality is easier to quantify, there are no standardized criteria for calculating postoperative complication rates. To improve the quality of further studies and recommendations for standardization of surgical treatment of gastric cancer and its complications, there is a need to study the differences in 90-day postoperative morbidity and mortality in different clinics and centers of the Russian Federation.

Eligibility Criteria:
Inclusion Criteria:

All consecutive patients with primary gastric malignancy (including Siewert III) undergoing elective surgery with curative intent (either total or partial gastrectomy) via open, laparoscopic or robotic approach between 18th March 2024 and 18th September 2024.

Exclusion Criteria:

* Patients with clinical evidence of metastatic disease, including positive peritoneal cytology on previous staging laparoscopy,
* Patients with known synchronous cancer;
* Patients with Gastrointestinal stromal tumors (GIST)
* Presence of gastroesophageal junction (Siewert I and II) malignancy;
* Patients submitted to Emergency surgery or surgery without curative intent;
* Patients undergoing additional surgery (except cholecystectomy) along with surgery for gastric cancer.
Soft Tissue Massage Along With Mobilization Technique on Symptoms and Functional Status of Carpal Tunnel Syndrome

The objective of this experimental study is to determine the effect of soft tissue massage along with mobilization technique on intensity of pain by visual analog scale and functional status by using Jamar hand-held dynamometer, Pinch Gauge and Boston Scale for carpal tunnel syndrome questionnaire in Carpal tunnel syndrome patients. It is being conducted on patients with Carpal tunnel syndrome at Sindh Institute of Physical Medicine and Rehabilitation, Karachi and Neurological outpatient department of Dr. Ruth K. M. Pfau, Civil Hospital Karachi among Sixty participants with mild and moderate severity of Carpal Tunnel Syndrome will be randomly allocated in two groups after initial screening by a consultant physiatrist according to CTS-6 scale. Written informed consent will be taken from each participant. Group A will be treated with soft tissue massage (Medenci hand massage technique) along with joint (radiocarpal and inter-carpal) and median nerve mobilization slider technique while group B will be treated with joint (radiocarpal and inter-carpal) and median nerve mobilization slider technique only. Participant will be evaluated by visual analog pain scale, Boston scale of carpal tunnel syndrome, dynamometer and -pinch gauge, Center for Epidemiologic Studies Depression Scale and Pain Anxiety Symptoms Scale on day 1 and last treatment session.


Eligibility Criteria:
Inclusion Criteria:

* Consultant Physiatrist will be diagnosed patients of carpal tunnel syndrome on electro diagnostic test i.e. Nerve Conduction Studies.
* Mild and moderate severity of Carpal tunnel syndrome.
* Age: 18-50 years
* Both gender patients with unilateral involvement of the hand

Exclusion Criteria:

* Exclusion Criteria:

  * In electro diagnostic test, either motor or sensory deficit in the ulnar nerve and radial nerve.
  * Other Neurological problems ( cervical myelopathy, motor neuron disease like amyotrophic lateral sclerosis
  * Neoplasm around the affected arm
  * Presence of other musculoskeletal problems of upper quadrant (for example: rheumatoid arthritis or fibromyalgia, cervical radiculopathy)
  * Any recent history of trauma of upper extremity on affected side