cyrilzakka/clinical-trials huggingface dataset:
A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures

The main purpose of this study is to demonstrate acceptable performance and assess safety of the HARMONIC 700 Shears device in a post-market setting when used per the instructions for use in pediatric and adult surgical procedures.


Eligibility Criteria:
Inclusion Criteria:

Pediatric participants

* Non-emergent procedure (general) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU
* Less than 18 years of age at the time of procedure
* Participant's parent/legal guardian must give permission to participate in the study and provide written informed consent for the participant Adult participants
* Elective procedure (general, gynecological, urological, or thoracic) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU
* Elective procedure (general, gynecological, urological, or thoracic) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU

Exclusion Criteria:

Preoperative

* Physical or psychological condition which would impair study participation
* Participants of childbearing potential who are pregnant
* Enrollment in a concurrent interventional clinical study that could impact the study endpoints Intraoperative
* HARMONIC 700 Shears were not attempted to be used for at least one single vessel transection during the surgical procedure
Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With Moderate Hypertension

The purpose of this clinical research is to learn if moderate hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.


Eligibility Criteria:
Inclusion Criteria:

* Willing to provide written informed consent
* Subjects must have uncontrolled hypertension defined as:

  * average systolic blood pressure between 160 mmHg and 180 mmHg (while diastolic blood pressure is less than 110 mmHg) or
  * average diastolic blood pressure between 100 mmHg and 110 mmHg (while systolic blood pressure is between 130 mmHg and 180 mmHg)
* Subjects must be willing to discontinue their antihypertensive medication, if applicable.
* Men and women, ages 18 and older will be included.
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to one week after the study in such a manner that the risk of pregnancy is minimized. WOCBP must have a negative serum or urine pregnancy test within 72 hours prior to the start of study medication.

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Known or suspected secondary hypertension
* Hypertension emergencies or stroke within the past 12 months.
* Heart attack, angina or bypass surgery within the past six months.
* Significant kidney disease
* Significant liver disease
* Systemic lupus erythematosus
* Gastrointestinal disease or surgery that interfere with drug absorption
* Cancer during the past five years excluding localized squamous cell or basal cell carcinoma of the skin
* Currently pregnant or lactating
* Mental condition (psychiatric or organic cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the study
* Drug or alcohol abuse within the last five years
* Known allergy to irbesartan or diuretics
Warm Versus Conventional 2% Lignocaine for IANB Efficacy

The study compares the anesthetic efficacy of warm versus conventional 2% lignocaine for inferior alveolar nerve block in mandibular molars, evaluating success rates and onset time.

The study will be conducted following approval from the Institutional Ethics Review Committee, AFID (ANX "A"). A total of 200 eligible patients visiting the Operative Dentistry Department at the Armed Forces Institute of Dentistry will be invited to participate. The procedure will be explained to the patients in Urdu, and written informed consent will be obtained (ANX "B").

Patients will be screened for eligibility through medical history, clinical examination, necessary tests, and peri-apical radiographs. Those meeting the inclusion criteria will be randomly assigned to one of two groups using a scientific random number table.

Group 1: Patients will receive conventional 2% lignocaine (at room temperature).

Group 2: Patients will receive pre-warmed 2% lignocaine (at 42°C). Root canal treatment will begin after the inferior alveolar nerve block (IANB) is administered. 1.8 mL of the local anesthetic will be delivered over 60 seconds using a 27-gauge needle. The first investigator will randomize participants by having them choose one of two differently colored balls to determine which anesthetic preparation (conventional or pre-warmed) they will receive. The conventional 2% lignocaine will be commercially available 2% lignocaine hydrochloride with 1:200,000 epinephrine, while the pre-warmed solution will be heated in a thermostatically controlled water bath or feeder bottle warmer (Philips AVENT) to 42°C.

The second investigator, who will be blinded to group allocation, will evaluate pain immediately after the block is administered by asking patients to rate their discomfort on a Visual Analog Scale (VAS). The onset of anesthesia will also be measured by performing gingival probing every 15 seconds. After rubber dam isolation, access cavity preparation will be performed, and pulp therapy will be initiated by the first investigator. The pulp therapy will be completed as needed, and the teeth will be restored with light-cured composite resin.

Eligibility Criteria:
Inclusion Criteria:

* Permanent teeth with acutely inflamed pulp without swelling or draining sinus.
* Patient who have carious mandibular molars.
* Patients of either gender aged between 18-50 years old.
* Systemically healthy patients.
* Patients who agree to attend for recall appointments and provide a written consent

Exclusion Criteria:

* Patients on preoperative analgesics and antibiotics.
* Teeth with calcified canals and previously treated teeth.
* Pregnant and lactating mothers.
* Patients who are immunocompromised, anxious and mentally handicapped.
* Patients who are allergic to lignocaine.
* Non-vital or necrosed teeth.
HIV Screening in the Emergency Department Setting

Late diagnosis of HIV infection is believed to be responsible for high rates of HIV transmission. The purpose of this study is to determine whether targeted screening versus routine screening will identify a greater number of HIV infected participants. This study will also compare the costs of the resources used for targeted screening versus routine screening.

Novel strategies are needed to reduce HIV transmission, particularly among individuals who are unaware of their HIV status. Emergency departments (EDs) routinely receive individuals in a medical setting where an opportunity exists to screen them for HIV. The purposes of this study are to determine whether the proportion of tested participants identified as HIV infected by targeted screening exceeds routine screening and to determine whether the program resources used per infected patient identified are lower for targeted screening than for routine screening.

Participants will be recruited from the University of Cincinnati Emergency Medicine Clinical Trials Center. The existing ED-based clinical HIV counseling and testing program in a lower HIV prevalence area will randomly alternate between two strategies for offering testing to ED participants: 1) targeted screening based on self-reported HIV risk and 2) routine screening. Participants will be randomly assigned to the targeted or routine screening group based on their presence in the ED during randomized days and times.

At study entry an interview, blood collection, and counseling will occur. Participants will be telephoned following their ED visit to be given their negative results. Participants with positive results will be asked to return to the ED for notification, counseling, and connections to subsequent care. Participants who are HIV infected will be transferred to the University of Cincinnati Infectious Disease Center for care.

Eligibility Criteria:
Inclusion Criteria:

* Adult participants presenting for care in the ED

Exclusion Criteria:

* Participants cognitively unable or unwilling to consent for voluntary HIV counseling and testing
The Prospective Cohort Study to Evaluate the Preventive Efficacy of HPV Vaccine in Japanese Women Aged 27-45 Years

A nonrandomized, non-double blinded prospective cohort study to evaluate the preventive efficacy of quadrivalent HPV6/11/16/18 vaccine for the persistent infection of HPV16 genotype or HPV18 genotype in Japanese women aged 27-45 years.

A series of evidence for HPV vaccines has demonstrated the efficacy in young women (Aged less than 26) across the globe. In contrast, limited evidence are available for the efficacy of the quadrivalent HPV6/11/16/18 vaccine in adult women (Aged 27+). Most importantly, evidence for Japanese adult women is not available to date. Nevertheless, , we hypothesize that the quadrivalent HPV6/11/16/18 vaccine demonstrate the efficacy also in Japanese adult women. The outcome from this trial will be the first local evidence, which brings a considerable impact in OB/GY academia where local evidence is weighed heavily compared with global evidence - serves as a strong basis to support catch up program of HPV vaccines for young adults. As a consequence, we believe this study will develop a local supportive evidence for prevention of HPV infection by an HPV vaccine in young adults, which results in substantial public health improvement through prevention of HPV infection in Japan where active recommendation is halted long time.

Eligibility Criteria:
Inclusion Criteria:

* Women with normal cytology results confirmed in cervical cancer screening programs from May 2019 to March 2020
* 27-45 years-old
* Intact uterus
* Willing to undergo the HPV-DNA test (cobas4800) within 12 months

Exclusion Criteria:

* Pregnant women
* Undergo treatment or the follow-up evaluation for CIN within the previous 12 months

  * Previously administered HPV vaccine
Malignant Progression of Anal Intra-epithelial Neoplasia in a Cohort of Patients

Evaluation of the 3-years anal carcinoma (AC) incidence in patient with anal AIN3 lesions, and factors associated with this AC. A retrospective cohort study will be conducted (2000-2013) followed by a prospective cohort study (starting in 2013) with new diagnoses of anal AIN3 lesion. The main outcome is histology proven AC. The 3-years incidence rate of AC will be calculated. Factors associated with AC will be estimated using a multivariate Cox regression model.

"Background : Incidence of anal carcinoma (AC) is considerably increasing, but no data on risk of AC in patient with anal AIN3 lesions are available, nor french recommendations about screening and treatment of anal AIN3 lesions.

Objective : Evaluation of the AC incidence in patient with anal AIN3 lesions, and factors associated with this AC.

Population : Patients with a diagnosis of anal AIN3 lesion will be included and followed for 3 years. Patients with past history of AC won't be included.

Study design : Retrospective cohort study will be conducted from 2000 using diagnostic codes of anal AIN3 lesion in histo-pathology departments. Then a prospective cohort study will be conducted with new diagnoses of anal AIN3 lesion.

Outcome : The main outcome is histology proven AC. AC identification can be done either by using diagnostic codes of AC in histo-pathology departments (for retrospective cases), or prospectively.

Statistics : The incidence rate of AC will be calculated. Factors associated with AC will be estimated using a multivariate Cox regression model.

Number of patients : 1000 Number of centers : 35 Length of follow-up: 3 years at least Length of study : 3 years of inclusion and 3 years of follow-up at least"

Eligibility Criteria:
Inclusion Criteria:

To be included in the cohort, patients have to:

- have an anal AIN3 (including Bowen's disease) diagnosed by histology (screening population, post-operative discovery...)

* Aposteriori for patients with a history of anal AIN3 complicated or not by an anal cancer. These cases will be identified from data bases of anatomopathology laboratories in hospitals since January 1st 2000.
* At the diagnostic for the new anal AIN3 Units care involved in the study are those involved in the follow-up of patients with anal pathologies en France, especially anal cancer. Samples are analyzed by the laboratories of anatomopathology of the hospitals where the patients are diagnosed. These points make the histological data bases reliable and allow clearly identifying cases of anal ain3 retrospectively since 2000.

Taking in account the number and quality of the units care involved in the study and the way cases are identified, we think our recruitment will be exhaustive in France, to limit selection bias.

- Patient's non opposition to study

Exclusion Criteria:

* history of anal carcinoma without any history of anal AIN3 lesion
* impossible follow-up for the duration of the study (3 years or more)
* patient aged under 18
Effect of Lumbo-sacral Magnetic Stimulation on Colonic Motility

The purpose of this study is to evaluate the effect of sacral nerve magnetic stimulation on the colonic motility in healthy subjects, in incontinent and constipated patients.


Eligibility Criteria:
Inclusion Criteria:

healthy volunteers

Exclusion Criteria:

pregnant women metallic material implanted organic digestive disease neuro-surgery
Prefatory Study to Explore Changes in Nasal Mucociliary Clearance and to Standardize Nasal Scraping Procedure

This study intends to evaluate the nasal mucociliary clearance (NMC) by determining the value obtained for saccharin transit time (STT) test over the course of 12 hours following a single cigarette use in adult smokers, to compare it relative to never smokers, and to examine the relationship between plasma nicotine levels and STT value in smokers and never smokers. Safety will also be monitored during the study.

The planned maximum study duration for a single study participant from Screening through completion of study will be 33 days.


Eligibility Criteria:
Inclusion Criteria to be met at Visit 1 and Visit 2:

* Male smokers aged ≥25 to ≤45 years old.
* Male never smokers aged ≥25 to ≤45 years old.
* Subject's BMI is comprised between 18.0 kg/m2 to 32.0 kg/m2, inclusive.
* Subject is healthy, as judged by the Investigator.

Additional Inclusion Criteria to allocate subjects in one of the two groups:

* Non-menthol cigarette smokers:

  * A positive urine cotinine test (≥200 ng/mL).
  * Smoked at least 20 cigarettes per day for at least the past 5 years.
  * eCO levels \>10 parts per million (ppm).
  * No plans to quit smoking in the next 3 months.
* Never smokers:

  * Subject who has smoked less than 100 cigarettes throughout their lifetime and no cigarettes in the past 3 years.
  * A negative urine cotinine test (\<200 ng/mL).
  * eCO levels ≤ 5 ppm.

Exclusion Criteria:

* As per the Investigator's judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
* Inability to taste sweet within 60 minutes in the STT test.
* Any condition the Principal Investigator or designee has cause to believe would interfere with the procedures for upper or lower airway function. This could include, but is not limited to, nasal/septum deviations, or nasal polyps or nasal allergies.
Collection of Anonymized Samples

This is a generic sample collection study for collecting blood, stool, rectal swabs, nasal washes, nasopharyngeal aspirates, nasopharyngeal swabs, throat swabs, nasal swabs, and urine from human sources. Subjects will be recruited from BioFire Diagnostics employees and from the general community. Subjects may be asked about recent or ongoing illness at the time of specimen collection and these symptoms will be recorded and attached to the sample. No other identifying information will be collected and the samples will be kept anonymous.The samples may be used internally or by external sites, such as the clinical study sites, for evaluating and determining performance characteristics of in vitro diagnostic devices.


Eligibility Criteria:
Inclusion Criteria:

* Consenting adult

Exclusion Criteria:

* Weigh less that 110 lb for blood collection
Mechanism of Action of Fluticasone Furoate in Childhood Obstructive Sleep Apnea Syndrome

The purpose of this research is to find out how a nasal spray (fluticasone furoate), sometimes given to children with obstructive sleep apnea syndrome (OSAS), works on certain cells within a child's adenoids. We hypothesize that intranasal steroids lead to an upregulation of T regulatory cells in the adenoid tissues of children with OSAS. This will result in a local reduction in inflammation and edema explaining the improvement in OSAS.

The objective was to determine the effect of intranasal corticosteroid therapy on T-regulatory cells and other inflammatory cytokines in adenoid tissues in children with obstructive sleep apnea syndrome.Children were randomized to either no treatment or treatment with fluticasone furoate nasal spray, 55 μg/nostril daily, for 2 weeks before adenotonsillectomy. Adenoid tissue was obtained at the time of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Age: between 2 and 12 years
* Polysomnogram results showing AHI \>5/hr irrespective of saturations
* No other significant medical problems except well controlled asthma
* No chronic medication intake except bronchodilators and leukotriene receptor antagonists
* No systemic steroids within the past month
* No intranasal steroids within the past 2 weeks

Exclusion Criteria:

* Patients with OSAS who are overweight (BMI\>95th percentile for age) or who have neurological or craniofacial abnormalities as these tend to have OSAS related to these factors per se.
* Females of the specified age group who have already had their first period.
A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection

This is a multicenter, open label, randomized Phase 3 clinical study to evaluate the efficacy and safety of the combination of tobevibart + elebsiran for the treatment of chronic hepatitis delta in comparison to delayed treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ages 18 to 70 years at screening
2. Chronic HDV infection for \>/= 6 months
3. On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA \< 20 IU/ml at screening, currently on locally approved NRTI therapy
4. Serum ALT \> ULN and \< 5x ULN
5. Non-cirrhotic or Compensated Cirrhotic Liver Disease at screening

Exclusion Criteria:

1. Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation.
2. History of significant liver disease from non-HBV or non-HDV etiology
3. History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients.
4. History of anaphylaxis
5. History of immune complex disease
6. History of autoimmune disorder
7. History or evidence of alcohol or drug abuse within 6 months before screening or a positive drug screen at screening unless it can be explained by a prescribed medication
Effect of Ultrasound-guided Insertion on Peripheral Catheters Related Complications.

The purpose of this study is to compare the appearance of complications after the insertion of peripheral venous catheters with two different techniques (traditional and ultrasound-guided).

All patients, whose parents were informed about the study and give written informed consent, will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to visualization/palpation or ultrasound-guided peripheral catheter insertion. All participants undergo a 10 days monitoring of the catheter status.

Eligibility Criteria:
Inclusion Criteria:

* Age between 0 and 18 years
* Patients in need of a peripheral venous catheter

Exclusion Criteria:

* Inability of insertion in both forearms (i.e. burnt, amputation)
* Patients in need of a central venous catheter
Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Obeticholic Acid (OCA) Compared to Placebo in Pediatric Participants With Biliary Atresia, Post-hepatoportoenterostomy

This study will evaluate the efficacy, safety and tolerability, as well as PK/PD of OCA in eligible pediatric participants with biliary atresia with successful hepatoportoenterostomy (HPE, also known as a Kasai portoenterostomy). The double-blind period comprises of 2 phases: dose titration phase and age expansion treatment phase.


Eligibility Criteria:
Inclusion criteria:

* Male or female pediatric participants from birth to \<18 years old. Note: Participants aged \<2 years old will not be enrolled until after review of safety data during the planned interim analysis and agreement from the Data Safety Monitoring Board (DSMB) that there is sufficient safety data to enroll this age group.
* Diagnosis of non-syndromic biliary atresia.
* Demonstrated successful HPE as defined by total bilirubin \<2 milligrams per deciliter (mg/dL) (34.2 micromoles per liter \[μmol/L\]) at least 3 months post-HPE procedure.

Exclusion criteria:

* Prior liver transplant or active status on transplant list.
* Participants diagnosed with biliary atresia splenic malformation (BASM).
* Conjugated (direct) bilirubin ≥ upper limit of normal (ULN) of site-specific reference range. If conjugated bilirubin is not available: total bilirubin ≥2 mg/dL (34.2 mol/L).
* Platelets \<120,000/μL
* International normalized ratio (INR) ≥1.5.
* Current or history of complications of decompensated chronic liver disease including:

  1. Gastroesophageal varices and/or variceal bleeding
  2. Clinically evident ascites related to portal hypertension
  3. Hepatic encephalopathy
  4. Prior placement of portosystemic shunt
  5. Hepatopulmonary syndrome or portopulmonary hypertension
  6. Hepatorenal syndrome
  7. Any evidence of portal hypertension based on imaging (e.g., cavernous transformation of portal vein, abdominal varices, etc.)
  8. Hepatocellular carcinoma
  9. Childs-Pugh B or C
* Height and weight Z-score \<-2 per site-specific reference ranges.
* Acholic (pale) stools.
* Aspartate aminotransferase (AST) \>4x ULN.
* Alanine aminotransferase \>4x ULN
* GGT \>500 Units per Liter (U/L)
* On anticoagulation therapy
* Albumin \<3.5 grams per deciliter (g/dL).
* Inability to swallow tablets (i.e., tablet or mini-tablet formulations).