cyrilzakka/clinical-trials huggingface dataset:
Use of Smart Glasses for Ultrasound Guided Peripheral Venous Access

Investigators aimed to explore the feasibility of smart glasses connected to a wireless ultrasound transducer for the peripheral venous access. Residents who have basic skills of ultrasound guided procedure participate in the simulation. Each participant plays the following two roles for ultrasound guided peripheral venous access; ultrasound guided peripheral venous access with and without wearing smart glasses. The order of performing two roles is determined by a randomized process and the gap between two roles are five days. The primary outcome is the time of successful blood aspiration, and secondary outcomes are first time success rate, the number of skin puncture, the number of needle redirection, the number of head movement, and subjective difficulty.


Eligibility Criteria:
Inclusion Criteria:

* Doctors who have basic skill for the ultrasound guided procedures and agree to participate the simulation

Exclusion Criteria:

* Doctors who do not agree to participate the simulation
* Doctors who do not have basic skill for the ultrasound guided procedures
Can Overall Adenoma Detection Rate Replace Screening Adenoma Detection Rate ? Multicenter Study

This is a prospective equivalence colonoscopy study evaluating whether overall adenoma detection rate (ADR) is a reliable alternate for screening ADR. Overall indication includes screening, surveillance, and diagnostic indications.

This multicenter study will be conducted by 18 colonoscopists from 5 hospitals in Taiwan, including Evergreen general hospital, E-da hospital, E-da Dachang hospital, Linkou Chang Gung memorial hospital, and Keelung Chang Gung memorial hospital, and plans to recruit 2700 prospective participants in a 2-year period. Felix W. Leung from Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System (USA) will be involved in the study design, and will participate in data analyses and report preparation. Consecutive patients aged ≥50 years undergoing colonoscopy are eligible for enrollment. Positive fecal immunochemical test (FIT+) is considered as an independent indication category and the colonoscopy indications are categorized into 4 groups: screening, surveillance, diagnostic, and FIT+. Overall indication will be subdivided into overall excluding FIT (overall-non-FIT) group and overall including FIT (overall-FIT) group. In this study, the investigators plan to (1) compare individual ADR across 4 colonoscopy indication categories (screening, surveillance, diagnostic, FIT+); (2) explore correlations between screening ADR and overall-non-FIT and overall-FIT ADRs, respectively.

Eligibility Criteria:
Inclusion Criteria:

* consecutive patients aged ≥50 years undergoing colonoscopy are eligible for enrollment.

Exclusion Criteria:

* high risk family history of colorectal cancer (CRC) e.g., familial adenomatous polyposis, hereditary non-polyposis CRC syndrome, multiple first degree relatives with CRC, or a single first degree relative with CRC at \<60 years
* serrated polyposis syndrome
* inflammatory bowel disease
* colonoscopy to remove a large neoplastic polyps
* obstructive lesions of the colon
* gastrointestinal bleeding
* current participation in other studies
* hospitalized patients
* mental retardation
* pregnancy
* refusal to provide a written informed consent.
Efficacy and Safety of 675-nm Laser for Dorsal Hand Rejuvenation

This study aimed to evaluate efficacy and safety of 675-nm laser for dorsal hand rejuvenation in Thai patients. Twenty-six subjects aged 50 to 65 years diagnosed with wrinkle and solar lentigines on both dorsums of hands were included and treated with RedTouch for 3 times every 4 weeks. Then, they were follow up at 3 and 6 months after the final treatment. The measurement of 5-point Global Aesthetic Improvement Scale scores by physicians and subjects were conducted. Moreover, pigmentation level, wrinkle and texture were also recored using Antera. Elasticity was measured using Cutometer.

RedTouch parameter included Moveo, power 5 W, Energy/DOT 500 mJ/DOT, then Standard, power 4 W, spacing 2000 μm, 1 pass per side.

Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with wrinkles and solar lentigines on both dorsum of hands

Exclusion Criteria:

* Pregnant or lactation
* Sugjects with a history of allergy to near-infrared wavelength or photosensitizing agents
* Subjects who have been treated with any kind of energy-based device on both dorsum of hands 6 months prior to the inclusion
* Subjects who have been injected with filler, or platelet-rich plasma on both dorsum of hands on their faces 6 months prior to the inclusion
* Active skin infections
* History of hypertrophic scars or keloids
Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes

This trial is conducted in Asia and Oceania. The aim of this trial is to compare the efficacy and safety of human insulin produced by the current process and the NN729 process in type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Duration of diabetes for at least 12 months
* Basal/bolus treatment with human insulin for at least 2 months preceding trial start
* Body Mass Index (BMI) lesser than or equal to 35.0 kg/m2
* HbA1c lesser than or equal to 12.0%

Exclusion Criteria:

* Proliferative retinopathy or maculopathy requiring acute treatment or laser treatment within the last 6 months
* Any condition that the investigator and/or sponsor feel would interfere with trial participation
* Known or suspected allergy against trial product or related products
Study of Giant Viruses of Amoebas Infections in Children Suffering From Gastroenteritis

The discovery in 2003 by isolation of amoebas Mimivirus, the world's largest virus at the Research Unit on Tropical and Emerging Diseases in Marseille revealed fascinating information about the definition and evolution of viruses. Its genome encodes about 1,000 proteins. Three other viruses were then isolated from amoebas in this unit:Two other giant viruses, Mamavirus Marseillevirus then, and the first virus a virus, named virophage, which led to highlight the role of amoeba (Acanthamoeba spp. ) such as spawning giant viruses and compounds of bacterial origin or cellular proteins This project focuses on the detection and analysis of new viral agents (viruses and virophages giant amoeba environmental) and their involvement in human pathology.

The objectives of this study are observational: detect and document the presence of giant viruses and virophages of amoebae in the faeces of children presenting to the pediatric emergency reception service of the North Hospital in AP -HM with or without clinical evidence of gastroenteritis.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted in the Pediatric Emergency Service of Northern Hospital, Marseille, France
* Patient aged ≤ 15.3 years, male or female;
* Patient for whom a microbiological exam should be performed during the clinical management, with or without a clinical diagnosis of gastroenteritis (ie including diarrhea which will be defined by the issuance of at least three molded or watery stools per day for more than 24 hours) at the time of the collection of stool;
* Patient for whom informed consent was read, understood, signed by a parent or legal representative.

Exclusion criteria

* Patient aged \> 15.3 years;
* Patient for whom informed consent is not signed by a parent or legal representative.
Ischemic Preconditioning to Prevent Acute Kidney Injury

The purpose of this study is to learn about the impact of ischemic preconditioning in reducing contrast induced kidney damage in people with pre-existing kidney problems who are undergoing cardiac catheterization procedures.

Ischemic preconditioning is thought to work by down-regulating pro-inflammatory gene expression and up-regulating anti-inflammatory gene expression in leukocytes. There is a local release of vasodilators, including adenosine and nitric oxide that are thought to have renal protective effects \[16\]. More is known regarding ischemic preconditioning in the heart, where it has been shown to decrease the adenine nucleotide pool, increase creatine phosphate and intracellular glucose, decrease ATP depletion, and lactate and H+ accumulation. This leads to sodium maintenance of the transmembrane sodium gradient that prevents intracellular edema. Ischemic preconditioning is thought to yield protection in the first minutes of reperfusion. Activation of the adenosine A1, bradykinin, and opioid receptors is thought to trigger protection. This is supported by the interference with protection if an adenosine receptor antagonist is administered. The role of reactive oxygen species as part of the protective mechanism has also been described via mitochondrial mKATP channels which lead to increased production of protective superoxide. Protein kinase C may also be involved in the protective mechanism of ischemic preconditioning, however the exact mechanism is unknown and controversial.

Eligibility Criteria:
Inclusion Criteria:

* Stage III-IV chronic kidney disease (with serum creatinine at or above 1.4 mg/dl and eGFR 15-55 ml/min/1.73m2 calculated by the Modification of Diet in Renal Disease formula)
* Undergoing planned coronary angiography (including both cardiac and peripheral vascular) and/or intervention at KUMC

Exclusion Criteria:

* Patients with normal renal function (stage 0 to 2 chronic kidney disease and/or serum creatinine less than 1.4 mg/dl)
* Inability or unwillingness to provide consent
* Patients undergoing hemodialysis or peritoneal dialysis therapy
* Patients with renal artery stenting
* Hemodynamically unstable patients
* Patients with acute or acute on chronic heart failure
* Patients who are unable to undergo the study procedure due to any upper extremity problems such as prior amputation, prior radical mastectomy, etc
* Patients who have not been hydrated prior to procedure using the standard protocols
Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults

The study employs tau positron emission tomography (PET) imaging in a well-characterized multi-racial/ethnic cohort to examine the extent to which tau pathology is associated with cognition, differences in tau pathology across racial/ethnic groups, and the relationship between MRI markers of small-vessel cerebrovascular disease and tau pathology. The study also investigates amyloid-dependent tau spreading.

Deposition of hyperphosphorylated tau protein is observed in several neurodegenerative diseases including Alzheimer's Disease (AD), progressive supranuclear palsy, corticobasal degeneration, chronic traumatic encephalopathy, and frontotemporal lobar degeneration. Tau is a microtubular protein and its native function is to provide structural support to neurons. Paired helical filaments composed of dysfunctional tau protein are found in several neurodegenerative diseases. In AD, the clinical progression of dementia has been shown to correlate with the amount and topographical spread of tau throughout the brain. Therefore, detecting and quantifying tau aggregate load in brain would have diagnostic and prognostic potential in clinical management of several neurological diseases. As disease modifying drugs that target tau are being developed, there is a critical need for a reliable method of detecting tau aggregates to confirm pathology in patients entering clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Aged 35 - 85 years
* Have either mild cognitive impairment or mild clinical Alzheimer's disease; or have no problem with memory or thinking.
* Able to participate in all scheduled evaluations and to complete all required tests and procedures
* Considered likely to comply with the study protocol and to have a high probability of completing the study

Exclusion Criteria:

* Past or present history of a certain brain disease other than mild cognitive impairment or mild clinical Alzheimer's disease.
* Certain significant medical conditions. Examples are uncontrolled epilepsy or multiple serious injuries.
* Unable to lie still for PET scans.
* Radiation exposure for research studies in the last year that would put you past allowable limits if included in this study.
* Participation in the last year in a clinical trial for a disease modifying drug for AD unless it can be determined that your received placebo and not active drug.
* Conditions that preclude entry into the scanner (e.g. claustrophobia, etc.).
* Inability to have a catheter in your vein for the injection of the radioligand (dye).
* Currently pregnant or breastfeeding.
The Effects, Perceptions, and Attitudes of Previously Sedentary Individuals Starting an Exercise Program

To examine whether starting an exercise program with or without education can influence dietary choices in previously sedentary of 20-40 years.

Subjects will complete an InBody test, demographic and physical activity survey, and food-frequency questionnaire via Qualtrics. Also, subjects may participate in a focus group and an individual interview.

A minimum of 150 minutes of moderate exercise required each week and must be spread out in at least 2 days.

Over the course of the study, subjects will complete InBody assessments, Food Frequency Questionnaire (items subjects are eating before, during, and after the investigator's study), and possible focus group questions (open-ended questions about thoughts and perceptions on exercise, nutrition knowledge, and health and nutrition history).

Eligibility Criteria:
Inclusion Criteria:

* Men and Women between 20 and 50 years.
* Previously sedentary for at least 6 months but have been exercising between one week and three months.
* Must be able to perform moderate intensity exercise at least two days per week in at least 30-minute sessions.

Exclusion Criteria:

* Pregnant women (self-reported).
* Currently injured that would prevent subjects from exercising.
Evaluation on Immunogenicity and Safety Profile of Trivalent OPV (tOPV Bio Farma)

The objective of this study is to compare the antibody response 30 days after two doses of t OPV

The trial design is phase II, randomized, double blind, prospective intervention study. The subject study are 240 healthy, full term, newborn infants.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, full term, newborns infants
* newborn residing within a relatively short and easily accessible distance A(\<30km) from the study clinic(s) and not planning to travel away during the entire study period
* Infant born after 37 weeks of pregnancy
* Infant weighing 2.5kg or more at birth (birth weight \>= 2.5kg)
* Healthy newborns, with no history of asphyxia or meconium aspiration
* Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
* Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial
* Mother at least elementary school graduate

Exclusion Criteria:

* Child concomitantly enrolled or scheduled to be enrolled in another trial
* Known history of congenital or acquired immunodeficiency (including HIV infection)
* Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature \>=37.5oC
* Newborns requiring hospitalization at birth
* Infant immunized with non-scheduled OPV or IPV during trial
Sensory Reconstruction of the Digits

A retrospective study is conducted with 151 patients who has a soft tissue defect of digit treated with the sensate flaps from February 2005 to March 2014. Based on the different regions of soft tissue defects, the patients in the study are divided into four groups: (1) thumb group treated with the bilaterally innervated and traditional kite flaps; (2) distal finger group treated with the single- and dual-innervated dorsal digital flaps; (3) proximal finger group treated with heterodigital neurocutaneous island flap; and (4) awkward region group treated with Litter flap. The main outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap, and pain and patient satisfaction.

At final follow-up, sensory restoration of the flap is measured using the static 2PD test and Semmes-Weinstein monofilament test. Using the visual analogue scale (VAS) that consists of a 10 cm line, patients are asked to report pain sensations of the recipient site. Patients report their satisfaction with functional recovery of the injured finger according to the Michigan Hand Outcomes Questionnaire that is based on a 5-point response scale.

Eligibility Criteria:
Inclusion Criteria:

* thumbtip degloving injury with a projecting tip of exposed bone or/and pulp defect; the defect ≥2 cm in length associated with the transected digital nerves in both sides; necessity to preserve thumb length; patient at or younger than 55 years of age

Exclusion Criteria:

* injury to the dorsum of the proximal or/and middle phalanx of the index finger; injury to the course of the FDMA; thumb nail bed defect; radial or ulnar portion of thumbtip or pulp defect
Physiotherapy in Knee Osteoarthritis

Osteoarthritis symptoms can be managed with non-drug treatments such as patient education, exercise or weight loss interventions. Cryotherapy is one of the effective method to reduce joint inflammation, pain and improve function. Another method is joint mobilization, which can also reduce pain and improve function. Based on this theory, it was hypothesized that cryotherapy will have better effect on pain and the quality of life, whereas joint mobilization will be more effective on knee function. The aim of the study was to compare the effects of different physiotherapy methods on pain, knee joint function and quality of life in individuals with osteoarthritis.

Study included 63 participants with knee osteoarthritis. All subjects were randomly assigned to one of 3 groups: exercise group (n=21), exercise + cryotherapy group (n=21), or exercise + joint mobilization group (n=21). VAS scale was used to assess the pain, quality of life was evaluated with Short Form 36 Health Survey Questionnaire (SF-36) questionnaire, knee ranges of motion were measured using a goniometer, strength of the muscles was assessed on the Oxford 5 point scale, The Western Ontario and McMaster Universities Arthritis Index (WOMAC) was used to evaluate knee osteoarthritis. All the participants received 30 intervention sessions.

Eligibility Criteria:
Inclusion Criteria:

* stage II of the knee OA;
* affected knee joint;
* pain of at least 3 points on the VAS.

Exclusion Criteria:

* Severe cardiovascular disease;
* Oncological Disorders;
* Allergy to cold / cold intolerance;
* Impaired lower limbs blood circulation;
* Fear of confined spaces;
* Pregnancy or lactation.
Evaluation of Structural and Functional Integrity of the Rotator Cuff After Total Shoulder Arthroplasty

The purpose of this study is to examine the rotator cuff muscles in your shoulder at one and two year post total shoulder replacement surgery.


Eligibility Criteria:
Inclusion Criteria:

* age \>45yrs
* primary diagnosis of osteoarthritis of the shoulder
* total shoulder replacement performed by Dr. Armstrong
* administered a local anesthetic mixture and not regional anesthesia
* all genders
* Fluent in written and spoken English
* Patients capable of giving informed consent

Exclusion Criteria:

* Known contraindications to CT/EMG
* Inability to provide informed consent
* History of recent trauma to the shoulder
* Atypical shoulder pain
* Other suspected shoulder pathology (i.e. tumor, infection)
* Pregnancy
* Bilateral total shoulder arthroplasty
Phase 3 Study of SNF472 for Calciphylaxis

The primary objectives are to assess the efficacy, safety, and tolerability of SNF472 compared to placebo when added to background care for the treatment of calciphylaxis (CUA).

The formation and growth of calcified deposits in arterioles and other small blood vessels appears to be fundamental to the development of CUA especially in end stage renal disease patients. This phase 3 double-blind, randomized, placebo-controlled study is designed to assess the effect of SNF472 when added to background care to improve wound healing, as evaluated using Bates-Jensen Wound Assessment Tool (BWAT) scoring and pain as reported by the subject using a VAS scale. The study consists of a double-blind, randomized, placebo controlled period of 12 weeks followed by an open-label period of 12 weeks.. .

Eligibility Criteria:
Inclusion Criteria:

* Female or male subjects, 18 years of age or older
* Receiving maintenance HD in a clinical setting for at least 2 weeks prior to screening
* Clinical diagnosis of CUA by the Investigator including ≥1 CUA lesion with ulceration of the epithelial surface
* CUA wound-related pain shown by a Pain VAS score ≥50 out of 100
* Primary lesion that can be clearly photographed for the purpose of protocol-specified wound healing assessments.
* Willing and able to understand and sign the informed consent form and willing to comply with all aspects of the protocol

Exclusion Criteria:

* History of treatment with bisphosphonates within 3 months of baseline
* Severely ill subjects without a reasonable expectation of survival for at least 6 months
* Subjects with a scheduled parathyroidectomy during the study period
* Expectation for kidney transplant within the next 6 months based on Investigator assessment or identification of a known living donor
* Pregnant or trying to become pregnant, currently breastfeeding, or of childbearing potential (including perimenopausal women who have had a menstrual period within one year) and not willing to comply with protocol required contraception criteria
* Significant noncompliance with dialysis
* History of active malignancy within the last year with the exception of localized basal cell or squamous cell carcinoma
* Clinically significant illness other than CUA within 30 days
* Participation in an investigational study and receipt of an investigational drug or investigational use of a licensed drug within 30 days prior to screening.
* History or presence of active alcoholism or drug abuse as determined by the Investigator within 6 months
* Mental impairment, current significant psychiatric disease, or other conditions or circumstances that would make the subject unlikely to complete the study or comply with the study procedures.
* Subjects whose CUA lesions exhibit significant improvement, in the opinion of the Investigator, between the first and second screening visit
Pain Relief After Forefoot Surgery

The aim to test whether continues local anaesthetic infusion via tibial catheter or wound catheter will improve pain relief following forefoot surgery

In this sequential prospective randomised, controlled clinical trial,75 Patients undergoing forefoot surgery will be randomized into three groups (tibial, wound, control). All groups will receive ankle block ± general anesthetic (standard technique). The tibial group will have a tibial catheter inserted through which local anaesthetic will be infused. The wound group will have a catheter inserted directly into the wound immediately after surgery. The control group will have a sham catheter (covered by a bandage across foot) attached to a pump which will not infuse. Patient maximum pain scores (primary outcome measure), nausea/ vomiting, analgesia use, satisfaction and sleep disturbance will be recorded postoperatively. All groups will be then followed by telephone calls 48 hours. Patients will be instructed to come to the clinic on the 4th postoperative day where the catheter will be removed.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older (ASA I \& II)
* Able to give written consent
* Patients having elective forefoot surgery with a planned ankle block.
* Expected postoperative pain to be at least moderate in severity the day following surgery

Exclusion Criteria:

* Refusal
* Inability to communicate
* History of alcohol or opioid abuse (also chronic opioid user)
* Mental or medical conditions which may affect quantifying pain scores (VAS)