cyrilzakka/clinical-trials huggingface dataset:
Clinical Study About Blood Pressure Measurement Efficacy on Multifunction KEITO

The purpose of this trial is to determine the accuracy of the Blood Pressure (BP) measurement of multifunction KEITO devices under test requirements of the Standard American National Standards Institute(ANSI)/Association for the Advancement of Medical Instrumentation(AAMI)/International Organization for Standardization (ISO): ANSI/AAMI/ISO 81060-2:2009.

Nowadays is important controlling our basic health parameters. Due this, the multifunction KEITO Devices was designed to offer to the general public a convenient way to do so easily in the public sites.

One of the most important parameter is the Blood Pressure (BP)measurement. To warrant their efficacity and accuracy, was essential to perform this trial to ensure that the measurements obtained meet with the requirements of the specific U.S. standard about Non-invasive sphygmomanometers.

By Validating with auscultatory reference sphygmomanometer, as defined on the ANSI/AAMI/ISO 81060-2:2009 , we have been intending to demonstrate that the multifunction KEITO devices, particularly about the Blood Pressure (BP) Measurement, have the same efficacy and accuracy as the conventional auscultatory sphygmomanometers.

To include most of the groups of Blood Pressure (BP) measurements types on this clinical trial, a great variety of BP ranges have been selected, always in accordance with the standard.

Eligibility Criteria:
Inclusion Criteria:

* Wrist circumference: 12 to 20 Cm
* At least 5% of the readings shall have Systolic BP\<=100 mmHg
* At least 5% of the readings shall have Systolic BP\>=160 mmHg
* At least 20% of the readings shall have Systolic BP\>=140 mmHg
* At least 5% of the readings shall have Diastolic BP\<=60 mmHg
* At least 5% of the readings shall have Diastolic BP\>=100 mmHg
* At least 20% of the readings shall have Diastolic BP\>=85 mmHg

Exclusion Criteria:

* Pregnant Women
Clinical Outcomes of Zirconia-reinforced Lithium Silicate Partial Coverage Crowns Compared to Lithium Disilicate Partial Coverage Crowns

The purpose of this randomized controlled clinical trial is to evaluate the clinical outcomes of Partial Coverage Restorations fabricated with zirconia-reinforced lithium silicate ceramic system compared to partial coverage restorations fabricated with lithium disilicate ceramic system.

This study is constructed to assess in patients with carious vital posterior teeth whether the use of Vita Suprinity® (VITA Zahnfabrik H. Rauter GmbH \& Co.KG- Germany) Zirconia reinforced lithium silicate partial coverage restorations will result in higher survival rates and better patient related outcome scores compared to IPS-e.max® CAD (Ivoclar Vivadent AG, Schaan - Liechtenstein) lithium disilicate partial coverage restorations.

Eligibility Criteria:
Inclusion Criteria:

* Participants:
* Good oral hygiene, papillary bleeding index (PBI) \< 35%.
* Positive patient acceptance to participate in the trial.

Teeth:

* Carious class II or MOD lesions
* Vital upper or lower posterior teeth with no signs of irreversible pulpitis.
* Normal occlusion
* Single tooth restoration (no edentulous space that requires fixed prosthesis)

Exclusion Criteria:

* Participants
* Pregnancy.
* Disabilities.
* Systemic disease or severe medical complications.
* Bad oral hygiene
* Heavy smoking.
* Xerostomia.
* Lack of compliance.
* Evidence of severe bruxism, clenching, or temporomandibular disorders.

Teeth:

* Deep carious defects (close to pulp, less than 1 mm distance).
* Periapical pathology or signs of pulpal pathology.
* Tooth hypersensitivity.
* Rampant caries.
* Non-vital or endodontically treated teeth.
* Sever periodontal affection.
* Tooth mobility
Dose-finding Study Using Pentostatin for Injection in the Treatment of Steroid-refractory aGvHD

To determine a safe and effective dose of pentostatin in steroid-refractory aGvHD and to identify the minimal effective dose of pentostatin defined as the lowest dose that produces a response in 20% or more of patients while producing treatment failure (defines as death, grade 3/4 toxicity, or progressive disease) in 40% or less of patients.


Eligibility Criteria:
Inclusion:

* Patients 6 months of age with grade 2 GVHD that is steroid-refractory
* Must be engrafted with ANC 1000/mL, may still be transfusion dependent for platelets and PRBC
* Time post stem cell infusion \< 100 days
* Written informed consent
* Must have adequate renal function (creatinine clearance 40 mL/min/1.73 m2)

Exclusion:

* Post-transplant lymphoproliferative disease
* Uncontrolled infection
* Mental illness or other condition preventing full cooperation with the treatment and monitoring requirements of the study
* ATG within the previous 14 days
* Other immunosuppressive agents (including monoclonal antibodies) when initiated within the previous 7 days
A Digital Art Activity to Enhance Self-Disclosure and the Detection of Psycho-social Distress in Adult Cancer Patients

To look at how a digital art activity may help cancer patients improve their ability to express their distress, symptoms, and lived experience.

Primary objective:

* To evaluate how engaging in a digital art activity might potentially cause changes in symptom reporting, based on pre/post self-reporting on the Edmonton Symptom Assessment System (ESAS) at time T3.

Secondary objectives:

* To evaluate the changes in symptom reporting, based on pre/post self-reporting on ESAS at different times of the study (T1, T2).
* To evaluate how a specific creative art making activity (T3), compared to an active control condition (T2; music listening) may or may not impact reporting ESAS.
* To monitor potential changes in distress disclosure, based on the self-report scoring on the Distress Disclosure Index score at T0, T2 and T3.

Eligibility Criteria:
Inclusion Criteria:

1. Age equal or greater than 18 years
2. Patients who are admitted in the hospital and have received a cancer diagnosis.
3. Suffering from solid cancer or hematological malignancy and receiving active treatment for their cancer.
4. Voluntary written consent.
5. Fluent in English or Spanish.

Exclusion Criteria:

1. Not being able to use a digital tablet
2. Being speech impaired or vision impaired
3. Patients who are cognitively impaired and unable to read or consent for the study
4. Pregnant women
NETs Formation in Patients With Recurrent Pyogenic Infections (NETS)

We aim to study if pathological NETs formation could be the underlying pathology among patients with recurrent infections and a normal screening of the immune system.

Our laboratory at Meir Medical Center, Kfar Saba, is the country's main center for neutrophil function, and serves about 80% of Israel's population. Patients are referred subsequent to recurrent, persistent, or unusual infections and after completing preliminary screening of the immune system and ruling out a humoral, cellular or complement immune deficiency. Initial workup includes chemotaxis, superoxide production (SOP), and bactericidal activity (BA). Based on test findings, further evaluation for a qualitative phagocytic disorder is conducted. Overall, impairment of phagocytic activity is found in about 33% (impaired chemotaxis in 16%, SOP in 6%, and BA in 24%). In the other 67%, no impairment of the immune function is found that can explain their tendency for recurrent pyogenic infections.

In 2004 a novel function of the neutrophil was identified: formation of neutrophil extracellular traps (NETs). Apparently, neutrophils are able to extrude part of their cellular contents in the form of DNA, histones and proteases, to form extra cellular NETS that trap and kill bacterial pathogens without the need for phagocytosis. We aim to study if pathological NETs formation could be the underlying pathology among these patients with recurrent infections and a normal screening of the immune system.

Eligibility Criteria:
Inclusion Criteria:

* Patients with recurrent, persistent, or unusual infections
* Referred for Neutrophil Functions

Exclusion Criteria:

* None
Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE

The goal of this randomized, double-blind, placebo-controlled clinical trial is to investigate the immunological effects of influenza vaccination outside of the influenza season on arterial inflammation in patients with a recent acute myocardial infarction (AMI). The primary objective is to compare the effects of influenza vaccination to those of a placebo in reducing post-myocardial infarction coronary inflammation as measured by coronary computed tomography angiography (CCTA). The main questions it aims to answer are:

Does influenza vaccination reduce arterial inflammation as measured by CCTA at week 8 after percutaneous coronary intervention (PCI) in comparison to baseline? Does influenza vaccination modulate systemic inflammation as measured by blood biomarkers and in-vitro challenge tests at week 8 after PCI in comparison to baseline? Researchers will compare the effects of influenza vaccination with those of a placebo.

Following informed consent patients are randomized in a 1:1 fashion to influenza vaccination or placebo up to 7 days following PCI. Blood tests for immune cell phenotyping and transcriptomic and proteomic analyses will be collected at baseline and 8 weeks after study inclusion. Patients will undergo CTCA at baseline (≤ 7 days of an AMI) and 8 weeks after PCI.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of non-ST-segment elevation myocardial infarction
* A finalized coronary PCI
* Male or non-fertile female subjects ≥18 years. (Females without childbearing potential, postmenopausal women and women with a history of hysterectomy or other medical conditions that preclude pregnancy)
* Written informed consent
* A CCTA can be scheduled within 7 days after PCI

Exclusion Criteria:

* Has received influenza vaccination within 6 months
* Other vaccination planned within 8 weeks (including covid-19 booster doses)
* Severe allergy to eggs or previous allergic reaction to influenza vaccine
* Cardiac surgery or staged PCI planned within 8 weeks
* Coronary stent involving the proximal RCA
* Suspicion of febrile illness or acute, ongoing infection
* Hypersensitivity to the active substances or ingredients of Vaxigrip or against any residues, such as eggs (ovalbumin or chicken proteins), neomycin, formaldehyde and octoxinol
* Subjects with endogenic or iatrogenic immunosuppression that may result in reduced immunization response
* Inability to provide informed consent
* Previous randomization in the ELIMINATE trial
* Any non-cardiovascular condition, e.g. malignancy, with a life expectancy of less than 1 year based on the investigator´s clinical judgement.
* Contraindication to coronary CT angiography (e.g., inability to lie flat, contraindication to glyceryl trinitrate, previous contrast allergy or contrast-induced nephropathy, severe renal impairment \[eGFR \<30 mL/min/1.73 m2\])
* Atrial fibrillation
* Uncontrolled chronic inflammatory disease
* Unable to comply with protocol requirements
Impact of CYP3A4*1G Polymorphism on Non-analgesic Effects of Fentanyl in Chinese Han Patients

Purpose: This study aimed to investigate the impact of CYP3A4\*1G genetic polymorphism on non-analgesic effects of fentanyl in Chinese Han patients. Methods: 200 patients receiving elective surgery under general anesthesia were recruited into this study. Venous blood was withdrawn for genotyping of CYP3A4\*1G before operation. Fentanyl 2 µg/kg was administered preoperatively. Bispectral Index (BIS), Respiratory rate(RR), etc at Tb (entering room), T0 (drug administration), T1 (2min), T2 (4min), T3(6min), T4(8min), T5(10min), T6(20min) were recorded.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists GradeⅠ-II,Patients undergo elective surgery for benign Reproductive diseases (including laparoscopic ovarian cyst removal, laparoscopic tubal ligation, laparoscopic tubal drainage, laparoscopic salpingoplasty, etc.) or breast disease.
* Aged 18-45 years
* Body Mass Index 18-25kg/m2,body weight 40-65 kilograms
* Agreed to participate the research

Exclusion Criteria:

* Difficult airway
* upper respiratory tract infection within 2 weeks
* history of allergy or long-term use of propofol and opioids
* self-rating anxiety scale before operation indicates anxiety
* pregnancy or lactation.
Turmeric Effect on Reduction of Serum Prolactin and Related Hormonal Change and Adenoma Size in Prolactinoma Patients

Prolactinoma is the most prevalent anterior hypophysis tumor. The principal treatment for this disorder is Dopamine agonist drugs including bromocriptin and Cabergoline. However, 50% of Bromocriptin treated and 17% of Cabergoline treated patients are resistant to these drugs. Curcumin is the main derivative of turmeric ,an old spice which is used frequently in Indian and Iranian cuisine. It has been proved that curcumin can reduce mammotrope cells proliferation and also intracellular hormone production. The purpose of this study is to evaluate the effect of turmeric on prolactinoma patients.


Eligibility Criteria:
Inclusion Criteria:

* hyperprolactinemia
* microprolactinoma

Exclusion Criteria:

* pregnancy
* macroadenoma
* neurologic signs due to tumor
A Study to Assess the Safety of Adacel® Vaccine

The objective of this study is to describe the safety of Adacel® vaccination in adults subjects in Vietnam. This study is conducted in accordance with Vietnamese regulation in support to Adacel® registration.

Primary objective:

To monitor the adverse effects of the vaccine ADACEL® from day 0 to day 30 after immunization.

Participants will receive a single dose of Adacel® vaccine and will be followed closely during 30 minutes post-vaccination period; a home visit will be made daily during 7 days following vaccination in order to monitor safety.

An additional visit will be conducted 30 days post-vaccination to collect safety information.

Eligibility Criteria:
Inclusion Criteria :

* Male or female (not pregnant) from 18-45 years of age.
* Healthy, with no current illnesses.
* Have not been immunized against diphtheria, pertussis and tetanus in the past 5 years.
* Women of childbearing age will agree to use birth control during the study.
* In good health, as verified by the following criteria: Heart rate, blood pressure, temperature and health history.
* Able to understand and comply with requirements of the study.
* A voluntary consent form is required before participating in the study.

Exclusion Criteria :

* History of allergy to any ingredient in the vaccine.
* A positive pregnancy test (for women of childbearing age) or women who are breastfeeding.
* Compromised immune system due to treatment of a progressive disease.
* Currently on oral or injected steroids, inhaled high-dosage steroids or other immunodeficiency or toxic drugs.
* History of taking Immunoglobulin or other products during the 3 months prior to participating in the study.
* Received other vaccines during the 4 months prior to participating in the study.
* Has an acute or chronic condition that affects safety (including but not limited to: chronic liver disease, some kidney pathologies, progressive or unstabilized nerve disorders, diabetes and organ transplants).
* Experienced a severe adverse event after receiving ADACEL® vaccine.
* History of acute illness with temperatures over 37.5ºC during the week before receiving the vaccine.
* Human immunodeficiency virus (HIV) infection.
* History of alcohol or drug addiction during the past 5 years.
* Plans to travel outside of the study area between shots and visits.
* History of Guillain-Barré syndrome.
Cosmetic Outcome Study of Lid Laceration Repair With Suture Versus Tissue Adhesive

This project is a randomized, controlled trial investigating wound cosmetic appearance after repair of traumatic lid lacerations with three different approaches to skin closure: absorbable sutures, non-absorbable sutures, and tissue adhesive. Photographs will be taken at two intervals after repair and later blindly assessed using standard cosmetic assessment scales. The investigators hypothesize that cosmetic wound outcome will be equivalent in across all three treatment arms.

This project is a randomized, controlled trial investigating the cosmetic appearance after repair of traumatic lid lacerations with three different approaches to skin closure: absorbable sutures (surgical gut suture), non-absorbable sutures (polypropylene suture), and tissue adhesive (octyl-2-cyanoacrylate). The population will include patients presenting to Memorial Hermann Hospital requiring repair of traumatic lid lacerations. The study will include partial thickness, full-thickness, and margin-involving lacerations where first standard layered tarsal and marginal suture repair will be performed if necessary, and then the patient will be randomized to superficial skin closure with either polypropylene suture closure, surgical gut suture closure, or tissue adhesive closure. Subjects will be followed in an outpatient setting at 1 week and 1 month post-repair at which time standardized photographs will be taken and later assessed using two standardized appearance assessment tools: Visual Analogue Scale (VAS) and Hollander Wound Evaluation Score (HWES).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Any laceration caused by trauma and involving the skin of the upper and/or lower eyelid.
* Must be able to understand and sign an informed consent when applicable and Health Insurance Portability and Accountability Act(HIPAA) form that has been approved by an Institutional Review Board (IRB) or follow standard informed consent procedure of the IRB

Exclusion Criteria:

* Eyelid lacerations that include avulsion or missing eyelid tissue
* Patients with known hypersensitivity to octyl-2-cyanoacrylate or previous poor reaction to octyl-2-cyanoacrylate
* Eyelid lacerations resulting in necrosis or ischemia of tissue prior to repair
* Patients who demonstrate intoxication or mental status changes that would make them unfit to provide informed consent for repair
Contraceptive Pathway and Contraception Continuation Rates

Women seeking contraception will be randomized to "usual care" or to a "Contraceptive Pathway"

Patients who present to the gynecology clinic for an annual, postpartum or contraceptive visit will be asked if they are interested in obtaining contraception by the front desk staff. If they respond yes, they will be seen in a triage or exam room by study personnel/medical assistant (MA) who will ask them if they would like to participate in the study, review the study and then randomize them to either the contraceptive pathway or usual care. The randomization will be done by opening sequentially numbered envelopes once they consent and while in the triage/exam room.

Patients triaged to the pathway will be handed an electronic tablet questionnaire while they are waiting to see the physician/(Advanced practice nurse (APN). The tablet contains a link to bedside.org, a public website which reviews contraceptive options. Vital signs will be collected as per usual care and recorded on both the questionnaire and in the electronic medical record(EMR). Study personnel will be available to offer the patient additional information on their choice of contraception or assist them with the link for information. The completed survey will be printed and placed in the subject room for review by the physician/APN. A copy will be kept in the subject binder and another will be scanned into the EMR.

Patients triaged to usual care will wait for their physician without the pathway questionnaire and will be asked the usual questions by the MA which will be recorded in the EMR. Vital signs will be collected and recorded in the EMR.

The physician/APN will see the subject as usual, review either the questionnaire or the EMR, review contraception options and initiate the contraception.

At completion of the visit, all woman will be asked if she would complete a satisfaction survey for her visit. She will be called at 2 weeks, 3, 6 and 12 months to discuss contraception initiation and continuation.

Eligibility Criteria:
Inclusion Criteria

* Women at risk for pregnancy
* Women able to read and write in English

Exclusion Criteria

* Women who have undergone permanent sterilization
* Women not sexually active with a male partner
* Women who intend to become pregnant in the next 12 months
Pivotal Observational CHLOE Study

This pivotal study is an observational, prospective assessment, multi-center, databank based, clinical study aimed to evaluate the performance of CHLOE™ algorithm in prediction of blastocyst formation.

This pivotal study is an observational, prospective assessment, multi-center, databank based, clinical study aimed to evaluate the performance of CHLOE™ algorithm in prediction of blastocyst formation.

Day 3 morphological grading will be performed by three clinical embryologists (hereafter "Assessors"), who will use standard embryo grading assessment techniques and will be blinded to the CHLOE™ information and to the actual blastocyte status (Yes/No).

Five independent embryologists (hereafter "Panelists") who will be masked to imaging data, to actual blastocyst status, and to each other evaluations will be provided with the morphological grading information performed earlier by the 3 assessors and with the age of subject or egg donor. All data will be presented to Panelists as full cohorts of embryos for each mother. Then they will provide their prediction on blastocyst status of each embryo twice: once the prediction will be based on morphology only and once on morphology plus CHLOE™ assigned score ("High", "Medium+", "Medium-", or "Low"). The two assessments will be done with a washout period of at least 2 weeks and no information will be provided to link the two assessments.

Eligibility Criteria:
Inclusion Criteria:

1. Women undergoing fresh IVF treatment using their own eggs or donor eggs.
2. Women at least 18 years of age; in case of a donor egg the donor shall be at least 18.
3. Total antral follicle count (AFC) of at least 12 as measured by ultrasound prior to stimulation (in cases where AFC is performed).
4. Basal follicle-stimulating hormone (FSH) level \< 10 IU or AMH \> 1.2 ng/ml
5. At least 8 normally fertilized eggs at bipronuclear (2PN) stage in this in-vitro fertilization cycle.
6. Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
7. At least 2 cells embryo.
8. Embryos were cultured in a Embryoscope ES-D (i.e., EmbryoScope model D - 6 spaces for patients, 12 wells each, resolution - 500\*500). The EmbryoScope was configured to the default values provided by EmbryoScope manufacturer.

Exclusion Criteria:

1. Gestational carriers
2. Concurrent participation in another clinical study
3. Previous enrollment in this clinical study (i.e., previous cycles of the same women)
4. History of cancer
5. Use of re-inseminated eggs
6. Embryos that underwent day 3 biopsy for preimplantation genetic testing (PGT)
7. Embryos that underwent biopsy at cleavage stage
8. Non-2PN embryos
9. Embryos with video frames in which the embryo is not clearly visible. Namely, videos with empty well, Bad Focus, Cropped Embryo, Air Bubble (see Annotation protocol, embryos with "Technical Errors" states)