cyrilzakka/clinical-trials huggingface dataset:
Prizma Pulse Oximeter Evaluation

This study is intended to evaluate performance of the new design sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically:

* SpO2 value range 70% to 100%
* 10 or more subjects, at least 3 of dark pigmentation
* At least 200 data points
* Meeting the following test required by the 2013 FDA Guidance on Pulse Oximeters - Premarket Notification Submissions and by ISO 80601-2-61 on Pulse Oximeters:
* 2013 FDA Guidance on Pulse Oximeters - Premarket Notification Submissions:

  * 4.1. ACCURACY OF PULSE OXIMETERS
  * 4.1.1 IN VIVO TESTING FOR SPO2 ACCURACY UNDER LABORATORY CONDITIONS
* ISO 80601-2-61:2011 Annex EE.2 and clause 201.12.1.101.2

  * 201.12.1.101 SpO2 accuracy of pulse oximeter equipment
  * 201.12.1.101.2 Determination of SpO2 accuracy

The device under test was the Prizma which is a phone cover biometric device that includes reflectance oximetry. This device is a spot checker that requires the patient to hold their finger on the sensor during the measurement. The subjects were asked not to move during the study. In order to get consistent measurements the fingers were taped to the test device. The tape acted mainly as a reminder, and there were some problems with finger movement. A radial arterial cannula was placed in either the left or right wrist of each subject.

Blood gas analysis to determine oxyhemoglobin saturation was performed on an OSM-3® multi-wavelength oximeter (Hemoximeter, Radiometer, Copenhagen). No subject was anemic (Hemoglobin ≤ 10gm•dl-1). Each subject had control data taken at the beginning of each experiment, with two control blood samples drawn while breathing room air. Hypoxia was induced to different levels of oxyhemoglobin saturation (between 70-100%) by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide. Oxyhemoglobin saturation was reduced to a series of targets and stabilized at the plateau value. Each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds. Two arterial blood samples were then obtained, approximately 30 seconds apart. A total of 24 samples were obtained per subject. Data were recorded by Bickler-Ye lab and provided for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female subjects
* Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile below.
* Meeting the demographic requirements listed above.

Exclusion Criteria:

* Smokers or individuals exposed to high levels of carbon monoxide that result in carboxyhemoglobin levels over 3% as tested by the BYL.
* Subjects who would be placed under medical risk under the desaturation profile listed below.
* Significant arrhythmia
* Age below 21 or over 50
* Pregnant women
The Utility of Mobile Based Application for Patient Reported Outcome Measures In Patients With Acetabular Fractures : A Randomized Clinical Trial

The primary objective of this study is to validate the feasibility of a remote patient monitoring (RPM) system using Mobile App in terms of the frequency of data interruptions and patient acceptance.

The secondary objective is to Improve quality of life and early prediction of the complications.

Acetabular fractures are articular fractures involving the hip joint that needs anatomical reduction and a strict long follow up after fixation. The percentage of patients with lost follow up is significantly high. Previously all other studies mainly focused on the radiographic outcome after acetabular fractures and rarely on patient reported functional outcomes and quality of life.The use of patient-reported outcome measures (PROMs) is increasing and may lead to modifications of treatment. Recent technologic advances, namely smartphones, capable of measuring outcomes after acetabular fractures are now very important in quantifying value-based care. This was previously accomplished through office assessments and surveys with variable follow-up, but this strategy lacks continuous and complete data. Studies show that these remote modes of follow-up are safe and that patients are as equally satisfied with them as they are with in-person follow- up care.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged more than 18 years who will have a surgery for an acetabular fracture at assiut university hospital.

Exclusion Criteria:

* Patients younger than 18years old
PTCy and and Ruxolitinib for GVHD Prophylaxis After HSCT With Thymoglobulin in Conditioning Regimen in Patients With Inborn Errors of Immunity

The aim of the current study is to evaluate the efficacy of combined regimen of GVHD prophylaxis with thymoglobulin in conditioning regimen and PTCY with ruxolitinib used after HSCT in patients with inborn errors of immunity (IEI)

Hematopoietic stem cell transplantation (HSCT) is widely used in inborn errors of immunity (IEI), and risks of graft-versus-host disease (GVHD) remain high. Use of post-transplant cyclophosphamide (PTCY) for GVHD prophylaxis revolutionized the outcomes of HSCT from mismatched related donor (MMRD). Use of ruxolitinib for GVHD prophylaxis demonstrates promising results in adult patients. Another well-known option for GVHD prevention is antithymocyte globulin. To evaluate the efficacy of combination of thymoglobulin with PTCY and ruxolitinib for GVHD prophylaxis, conditioning regimen containing treosulfan 30-42 g/m2, fludarabine 150 mg/mg, and thiotepa 10 mg/kg or melphalan 140 mg/m2 and GVHD prophylaxis regimen containing cyclophosphamide 50 mg/kg for MMRD, 25 mg/kg for matched unrelated and related donors at days +3, 4 post-HSCT and ruxolitinib at dose 7 mg/m2 from day +5 after HSCT will be used in patients with IEI.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥ 0 months and \< 21 years
2. Patients diagnosed with NBS eligible for an allogeneic HSCT
3. Signed written informed consent signed by a parent or legal guardian

Exclusion Criteria:

Concomitant severe somatic disease associated with an additional risk of severe complications
A Trial of Somatostatin With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding

Background: Efficacy of endoscopic variceal sclerotherapy in achieving initial control of acute variceal bleeding and five-day haemostasis has been shown to significantly improve when vasoactive drug is added. However, there is limited data whether addition of somatostatin, to endoscopic variceal ligation (EVL) improves the efficacy of EVL.

Aim: To compare EVL plus somatostatin versus EVL plus placebo in control of acute variceal bleeding.

Patients and methods: Consecutive cirrhotic patients with acute variceal bleeding from esophageal varices were enrolled in the trial. After emergency EVL, patients were randomized to receive either somatostatin (250 mcg/hr) or placebo infusion. Primary endpoint was treatment failure within 5 days. Treatment failure was defined as fresh hematemesis ≥2 hour after start of therapy or death.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of portal hypertension
* Having hematemesis and/or melena within 24 hour prior to admission
* Source of bleeding should be esophageal varices

Exclusion Criteria:

* Non-cirrhotic cause of portal hypertension
* Age \<12 or \>75 years
* Hepatic encephalopathy grade 3 or 4
* Renal failure with serum creatinine \>2 mg/dL
* Any evidence of bleeding from additional source apart from esophageal varices (like gastric varices, portal hypertensive gastropathy, erosions or ulcers including variceal ulcers)
* Patients already on vasoactive drugs like somatostatin or terlipressin during the current episode of bleeding
* Patients already received EVL or EST elsewhere during the current episode of bleeding prior to presenting to our hospital
* Patients with history of surgery for portal hypertension or TIPS
* Concomitant severe cardio-pulmonary disease
* Concomitant malignancy
* HVPG not possible within 24 hrs of presentation
* Patients refusing to participate in the study.
Decrease Implantation Site INFECTION : a Randomized Controlled Trial

Cardiovascular implantable electronic device (CIED) infections have been increasing out of proportion to the number of devices implanted the investigators investigated recent trends and possible causes of the increasing numbers of Cardiovascular implantable electronic device infections.

There are many studies on the preventive use of Antibiotics or povidone iodine to Cardiovascular implantable electronic device (CIED) infections.

But, studies of posterior pocket capsule removal is still limited.

The investigators had planned research on effects of posterior pocket capsule removal before cardiac devices replacement.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for cardiac devices replacement

Exclusion Criteria:

* under the age of 18
* take an antibiotic
* history of infection within 30 days
Comparing Therapeutic Hypothermia Using External and Internal Cooling for Post-Cardiac Arrest Patients

Controlled therapeutic hypothermia is a method of preserving neurological function post-resuscitation.It has been associated with improved functional recovery and reduced histological deficits in animal models of cardiac arrest.

Three randomized clinical studies have been reported showing improved neurological outcome and reduced mortality in post-resuscitation patients treated with hypothermia compared to controls. Of the various methods of inducing hypothermia, internal cooling using an endovascular catheter and external cooling using gel pads with a water based circulating system have shown the most promise. There have not been any studies looking at outcomes between the two methods of cooling.

Eligibility Criteria:
Inclusion Criteria:

1. Sustained return of spontaneous circulation (ROSC) after cardiac arrest, for more than 30 min
2. Patients aged between 18 to 80 years.
3. Patients who are hemodynamically stable, with a systolic BP \> 90 mmHg with or without inotropic support.
4. Patients comatose or unresponsive post-resuscitation

Exclusion Criteria:

1. Hypotension despite fluid and/or vasopressor support
2. Positive pregnancy test in women below 50 years
3. Premorbid status bedbound and uncommunicative
Hyperbaric Bupivacaine and Hyperbaric Levobupivacaine in C/S

Aim of the Study To compare the effects of hyperbaric bupivacaine plus fentanyl with hyperbaric levobupivacaine plus fentanyl on spinal block quality, haemodynamics and need for analgesics in patients undergoing elective cesarean section. Our hypothesis is that hyperbaric levobupivacaine will provide equal block quality, but better haemodynamic conditions compared to hyperbaric bupivacaine.

Material - Method 60 patients, American Society of Anesthesiology (ASA) group I-II, between the ages of 18-45 who were scheduled for elective cesarian section under regional anesthesia are going to be included. Patients with contraindications to regional anesthesia, known allergy, suffering from pregnancy induced hypertension or placenta previa will be excluded from the study.

Patients will not be premedicated. After routine monitorization , IV access and fluid replacement patients will be separated to two groups on a randomised manner. Under sterile conditions spinal anesthesia will be performed in the sitting position at the level L3-4 or L 4-5 via epidural-spinal combined including a 27 G spinal needle.

Group 1 will receive 8 mg hyperbaric bupivacaine plus 20 mcg fentanyl /2ml intrathecally.

Group 2 will receive 8 mg hyperbaric levobupivacaine plus 20 mcg fentanyl/2ml intrathecally.

The Hyperbaric form of Levobupivacaine is not available on market , so it will be prepared with the addition of % 30 dextrose by another anesthesiologist who will be blinded to the patients.

Preparation: 2 ml of %0,75 levobupivacaine + 0,8 mL %30 dextrose + 0,2 mL of saline will be mixed. So it will contain 5 mg levobupivacaine and %8 dextrose per ml.

Hypotension will be defined as a decrease in blood pressure more than % 30 percent of the basal measured systolic arterial pressure. Hypotension will be treated with 250 ml fast saline infusion and if no response with 5 mg of ephedrine IV. A heart rate under 50 beats/min will be defined as bradycardia and will be treated with 0.5 mg atropine i.v.. If the anesthesia is not sufficient 10 ml of % 0.25 levobupivacaine wil be administered through the epidural catheter. The level of sensory and motor block will be evaluated and recorded every 3 minutes at the beginning and after 15 minutes it will be checked every 5 minutes until the end of surgery. Maximum level of sensory block, time to reach T4 dermatome and time to regression of 2 segments will be recorded. Nausea-vomiting, pruritus and shivering will also be recorded. Baby delivery time, which will be defined as the time from spinal medication to clamping of the umbilical cord will also be recorded. Total time of surgery will also be recorded. The time for the first analgesic requirement will be noticed as well. Patient and surgeon satisfaction will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

elective cesarean section no other coexisting medical situation

Exclusion Criteria:

known contraindication to regional anesthesia coexisting pregnancy induced problem placental mislocation known allergy
Spastic Cerebral Palsy and Slackline

The aim of the present study was to assess whether supervised slackline training improves postural control in children and teenagers with spastic cerebral palsy (grade I and II of the Gross Motor Function Classification System).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis with any expression of spastic cerebral palsy and rated I-II on the Gross Motor Functional classification.
* Between 9 and 16 years of age.
* Ability to cooperate with simple instructions.
* Able to stand for at least 2 min without assistance.
* Able to walk at least 10 m without assistance.

Exclusion Criteria:

* Individuals were excluded if they underwent neuro or orto surgery during or up to one year prior to the study, botulinum toxin injection or intrathecal pump during or up to six months prior to the study and/or rotational osteotomies, if they expressed gait deviations limited by musculoskeletal contracture, presented specific medical or orthopedic conditions that precluded exercising
* or if they did not meet the eligibility criteria.
Characterization of Biliary Cell-derived Organoids from Bile of PSC and Non-PSC Patients

The purpose of this research is to create a collection of bile, bile duct brushings and medical information from people with Primary Sclerosing Cholangitis (PSC) and controls to learn more about changes that occur in the liver.

The study will ask participants to provide bile and/or bile duct cytology brushings at time of endoscopic retrograde cholangiopancreatography (ERCP) or cholecystectomy (gallbladder removal). The bile and brushings will be used to generate and perpetuate bile-derived organoids using an established matrigel-based protocol. These organoids will then be used in downstream experiments to better understand disease-specific alterations to biological pathways informative of disease pathogenesis

Eligibility Criteria:
Inclusion Criteria:

PSC

* Patients diagnosed with PSC between the age of 18 and 85.
* The diagnosis of PSC will be based on standard PSC criteria including clinical and biochemical evidence of chronic cholestasis of at least six months duration, positive cholangiographic findings and compatible liver biopsies if available.
* Women with PSC of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation. Patients with PSC and Cholangiocarcinoma will be included.

Controls

• Controls without history of PSC or evidence of other chronic liver disease of either gender that will participate in this study should be between the ages of 18-85.

Exclusion Criteria:

* Patients unable to provide inform consent.
* Prisoners and institutionalized individuals.
* PSC with orthotopic liver transplantation
* History of Roux En Y procedure
Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in NPC

This study is a multicenter, non-inferiority, open-label, randomized controlled Phase III clinical trial. It aims to compare the efficacy of modified delineation radiotherapy (experimental group) versus standard delineation radiotherapy (control group) in the prophylactic irradiation of neck lymphatic drainage areas III/IVa in nasopharyngeal carcinoma. The study evaluates the incidence of primary hypothyroidism, quality of life, and adverse events between the two groups.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged 18-70 years; 2. Pathologically confirmed nasopharyngeal carcinoma; 3. No positive lymph nodes in unilateral or bilateral regions III and IVa; 4. Clinical stage I-IVa (AJCC/UICC 8th edition), with no evidence of distant metastasis; 5. Normal thyroid function; 6. ECOG performance status of 0-1; 7. Treatment-naïve patients who have not received any prior antitumor therapy; 6. No contraindications to radiotherapy or chemotherapy; 9. Adequate organ function, meeting the following criteria: Hematologic criteria: WBC ≥ 4.0 × 10⁹/L, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L, HGB ≥ 90 g/L (no transfusion, blood products, or hematopoietic growth factors used within the past 7 days); Biochemical criteria: ALT and AST \< 1.5 × ULN, ALP \< 2.5 × ULN, total bilirubin \< ULN, BUN and creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 mL/min (calculated using the Cockcroft-Gault formula).

10. Voluntarily agreed to participate in the study, signed the informed consent form, demonstrated good compliance, and agreed to follow-up.

Exclusion Criteria:

1. History of other malignant tumors (excluding basal cell carcinoma/squamous cell carcinoma of the skin or cervical carcinoma in situ);
2. History of radiotherapy (excluding radiotherapy outside the planned target area for conditions such as melanoma);
3. History of neck surgery;
4. Any severe comorbidities that may pose risks to the study or affect compliance, such as unstable heart disease requiring treatment, kidney disease, chronic hepatitis, poorly controlled diabetes (fasting blood glucose \> 1.5 × ULN), or psychiatric disorders;
5. History of hyperthyroidism, hypothyroidism, or immune-related thyroid disorders;
6. Other family or social factors, as judged by the investigator, may force the study's early termination, compromise patient safety, or affect the collection of trial data.
The Feasibility of Drug Delivery to Infants During Breastfeeding

Parents commonly find giving medicines to babies, using oral syringes or spoons, difficult and emotionally stressful. In developing countries, additional stress arises due to hygiene difficulties and the lack of clean water. To overcome these challenges and encourage breastfeeding, we have developed the concept of a Therapeutic Nipple Shield, a delivery system that makes it possible to give medicine and nutrients to babies during breastfeeding. It consists of a silicone nipple shield that allows the release of medicine/nutrients into human milk during the feed. Presentations of a prototype to parents and staff at the Rosie Hospital was very positive, and encouraged this clinical study. This study aims to give a vitamin B12 supplement to babies during breastfeeding. The supplement will be placed into a nipple shield, both of which are commercially available, and the mother will breastfeed her baby as usual. Before and after the feed, we will 1) collect a small blood sample from the baby to see whether the vitamin levels in the infant have increased, 2) ask the mother to participate in two short interviews about her expectations and experiences using the Therapeutic Nipple Shield.


Eligibility Criteria:
Inclusion Criteria:

No known allergy or hypersensitivity against any ingredient used in the study Infant aged up to 12 months Confident breastfeeder (exclusively or non-exclusively)

Exclusion Criteria:

The participant may not enter the study if ANY of the following apply:

* Not confident at breastfeeding
* Infant not feeding properly
* Allergy or hypersensitivity against any ingredient of the commercially available Methylcobalamin Vitamin B12 Tablets (Just Vitamins Ltd, UK) used in the study (infant or mother)
* Medical conditions that could negatively influence swallowing, and thus breastfeeding
Study to Evaluate the Safety and Efficacy of JTE-051 in Subjects With Moderate to Severe Plaque Psoriasis

Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTE-051 administered for 12 weeks in subjects with moderate to severe plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with moderate to severe plaque psoriasis at least 6 months prior to Visit 1
* Plaque-type psoriasis covering ≥10% of body surface area (BSA) at Visit 1 and Visit 2;
* Psoriasis Area and Severity Index (PASI) score ≥12 at Visit 1 and Visit 2;
* Static Physician's Global Assessment (sPGA) score ≥3 at Visit 1 and Visit 2;
* Body Mass Index (BMI) ≤40 at Visit 1.

Exclusion Criteria:

* Medical history of treatment failure to any systemic agents for plaque psoriasis;
* Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis or other skin conditions at (e.g., clinically-significant eczema or severe acne) that could interfere with study evaluations at Visit 1;
* Presence or history of any itch due to underlying conditions other than plaque psoriasis which cause or influence pruritus of the skin (e.g., drug induced pruritus, significant other systemic diseases with itch) within 12 months prior to Visit 1;
* History of a clinically-significant infection (e.g., that required oral antimicrobial therapy) within 8 weeks prior to Visit 2;
* History of infections requiring hospitalization or parenteral antibiotic, antiviral, antifungal or antiparasitic therapy within 6 months prior to Visit 2 and no history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis);
Meir Medical Center Home Monitoring Clinic Registry

The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik ICD and CRTD patients.


Eligibility Criteria:
Inclusion Criteria:

* Approved indication for ICD or CRTD
* Implanted with or replaced with a Biotronik Lumax device
* Patient willing and able to sign consent form
* Willing and able to attend clinic visits and follow up schedule
* Transmission of more than 80% at 3-month follow up
* Patient older than 18 years

Exclusion Criteria:

* no indication for ICD or CRTD implant
* Life expectancy shorter than 12 months
* Pregnancy
* Participation in other clinical studies