cyrilzakka/clinical-trials huggingface dataset:
COA-APTIC Cognitive Interview Study of Caregiver and Clinician Assessment of Acute Pain in Infants and Young Children

Evaluate the content validity and comprehensibility of a caregiver observer-reported outcome assessment and clinician-reported assessments for acute pain in children aged 0 to \<2 years. The primary objective of the Qualitative Protocol in the UH3 phase study is to establish or create reliable Clinical Outcome Assessments (COAs) and endpoints that can assess acute pain during clinical trials of pain therapeutics specifically designed for infants and young children (0 - \<2 years).

The study aims to assess understandability (clarity) and content validity of the newly designed clinician-reported outcome (ClinRO) and the existing clinician-reported outcome (ClinRO) measures of acute pain in infants and young children who are 0 to \<2 years of age.

This qualitative research employs 60-minute cognitive interviews conducted through phone or zoom by a trained interviewer. The study involves caregivers with children aged 0 to \<2 years old who are experiencing or have experienced acute pain, and clinicians who dedicate at least half of their clinical time caring for pediatric patients within the same age range.

The data analysis will be of a qualitative nature and rely on in-depth interviews conducted with relatively limited sample sizes.

The study entails utilizing standard interview techniques and poses a negligible amount of risk. However, there is the potential risk of loss of confidentiality.

Eligibility Criteria:
Inclusion Criteria:

Caregivers

* Cares for a child who is both: Between 0 and \<2 years of age and experiencing or has experienced acute pain in the past four weeks in one of the following categories: Malignant or non-malignant visceral or hematologic disease; Surgery (or other procedure); Trauma or injury ; Congenital conditions
* Is over the age of 18 years
* Can speak and understand English or Spanish
* Is capable of and willing to provide informed consent for interview participation and to collect data from the child's medical record.

Clinicians

* Practicing clinician in a clinical care environment
* Treats or works with pediatric patients who are between 0 and \<2 years of age AND being treated for acute pain.
* Cares for pediatric patients \>50% of their clinical time.
* Holds one of the following titles/positions: physician, clinical pharmacist (Pharm D), nurse practitioner, physician's assistant, nurse (with a BSN/RN or higher)
* Is over the age of 18 years
* Can speak and understand English
* Is capable of and willing to provide informed consent for interview participation.

Exclusion Criteria:

* Lack of access to a telephone or computer for interview
* For caregivers, has a child with acute pain who is premature at less than 32 weeks corrected gestational age at the time of enrollment and no other eligible child.
Who Will Benefit From Bariatric Surgery for Diabetes?

A study investigating the influence of fat distribution, genetic susceptibility markers for type 2 diabetes (T2DM) and fat distribution, epigenetic and transcriptomic changes and gut hormone responses to a mixed meal on diabetes remission following bariatric surgery.


Eligibility Criteria:
Bariatric surgery group

Inclusion Criteria:

* Males and females planning to undergo RYGB
* 18-80 years
* Type 2 diabetes mellitus or prediabetes
* Stable weight for at least 3 months
* Obese (BMI ≥30kg/m2)
* Eligible for surgery on the National Health Service (NHS) under The National Institute for Health and Care Excellence (NICE) 2014 criteria

Exclusion Criteria:

* Current pregnancy
* Inability to give informed consent
* Type 1 diabetes
* Low fasting C-peptide
* Secondary diabetes or absence of β-cell function
* Unable to undergo DEXA, cirrhosis, ascites, or other condition that may modify body fat composition e.g. underlying malignancy
* Current smoker
* Participation in another (interventional) trial within the last 3 months
* Unable to understand English

Healthy volunteers

Inclusion criteria:

* Aged 18-80 years
* Male or female
* Body mass index 19 - 25 kg/m2
* Stable weight for at least three months

Exclusion criteria:

* Abnormal glucose tolerance and fasting glucose
* History of any medical, or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study
* Without access at home to a telephone, or other factor likely to interfere with ability to participate reliably in the study
* Pregnancy or breastfeeding
* Unable to maintain adequate contraception for the duration of the study
* Donated blood during the preceding 3 months or intention to do so before the end of the study
* Current smoker
* Participation in another trial within the last 3 months
* Unable to understand English
Sexual Dimorphism in Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes

Sex might interact with cardioautonomic neuropathy (CAN) in the development of macrovascular disease in patients with type 1 diabetes (T1D). The regulation of the autonomic system shows sexual dimorphism, and may contribute to the cardiovascular risk overload in women with T1D.

The aims of this project are:

A.1) Determining the prevalence of CAN and subclinical atherosclerosis in a large cohort of consecutive patients with T1D as a function of sex (cross-sectional study).

A.2.) Addressing the progression of CAN and subclinical atherosclerosis in patients with T1D as a function of sex (longitudinal prospective study).

A.3.) Investigating the influence of sex steroids and circulating biomarkers in the development and progression of CAN and subclinical atherosclerosis.

Research designs:

A cross-sectional design/prevalence screening study determining the prevalence of CAN as a function of sex in 320 consecutive individuals with DM1.

A longitudinal prospective study: the cohort of prevalence screening study will be prospectively followed, and the assessment of cardiovascular autonomic function and subclinical atherosclerosis will be repeated over time.


Eligibility Criteria:
Inclusion Criteria:

- Diagnosis of type 1 diabetes mellitus, as defined by ADA criteria

Exclusion Criteria:

* Renal transplantation or renal replacement therapy;
* prior diagnosis of macrovascular disease (CHD, cerebrovascular disease, carotid disease, PAD, or atherosclerotic aortic aneurism);
* ongoing pregnancy;
* diagnosis of types of diabetes mellitus other than type 1;
* diagnosis of types of neuropathy other than diabetic neuropathy.
Study to Assess the Safety and Effectiveness of the Penumbra System

This clinical evaluation is a prospective, single-arm, multi-center trial.

The purpose of this clinical evaluation is to assess the safety and effectiveness of the Penumbra System in the revascularization of patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease.

Purpose:

The purpose of this clinical evaluation is to assess the safety and effectiveness of the Penumbra System in the revascularization of patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease. Up to 125 evaluable patients will be enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

* Clinical signs consistent with acute ischemic stroke
* 18 to 79 years of age
* Neurological deficit resulting in an NIH Stroke Scale (NIHSS) score \> 8
* TIMI 0 or TIMI I flow in vessels accessible to the Penumbra System
* Signed informed consent
* Present within 8 hours of stroke symptom onset; ineligible or refractory to intravenous tissue plasminogen activator (t-PA) therapy if presenting within 3 hours of symptom onset.

Exclusion Criteria:

* Evidence of rapidly improving neurological signs of stroke at time of enrollment
* NIHSS \> 30 or coma
* Females who are pregnant
* Vessel tortuosity too difficult to allow endovascular access
* Known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an International Normalized Ratio (INR) \> 3.0
* Partial thromboplastin time (PTT) greater than 2 times the lab normal
* Admission platelets \< 30,000
* Pre-existing neurological or psychiatric disease that could confound the study results
* Known severe allergy to contrast media
* Uncontrolled hypertension
* Computed tomography (CT) evidence of significant mass effect with a midline shift
* CT reveals evidence of large hypodensity region \> 1/3 of the middle cerebral artery territory
* CT reveals evidence of intracranial hemorrhage
* CT reveals significant mass effect with midline shift
* Angiographic evidence of an arterial stenosis proximal to the occlusion that could prevent thrombus removal
* Angiographic evidence of preexisting arterial injury
* Life expectancy of less than 90 days
* Participation in another clinical investigation that could confound the evaluation of the study device.
Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis

To evaluate in combination with corticosteroid and local standard medical care the efficacy and safety of long-acting octreotide compared to placebo for the treatment of symptoms of inoperable bowel obstruction in patients with peritoneal carcinomatosis


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptoms and signs of inoperable bowel obstruction confirmed by a surgeon or clinic and radiographic assessment (CT scan or at least abdominal X-ray);
* Confirmed peritoneal carcinomatosis (with one of the following criteria : surgery, imaging and/or cytology);
* No corticotherapy at dose more than 1mg/kg equivalent-methylprednisolone, in the previous 2 weeks ;
* No chemotherapy in the previous week;
* No radio or chemotherapy planned at the inclusion and within the two weeks following inclusion
* Authorized concomitant treatments for local standard medical care : antiemetics, antispasmodics, anti-Histamine2 (H2) drugs blockers or proton pump inhibitor, analgesics; nasogastric tube

Exclusion Criteria:

* Abnormal coagulation (prothrombin time \< 60%, platelets \< 50x10\^9/L).
* Non authorized concomitant treatments :

  1. Anticholinergics such as scopolamine
  2. Other somatostatin analogues

Other protocol-defined inclusion/exclusion criteria may apply
Pilot Trial of Deferasirox in the Treatment of Porphyria Cutanea Tarda

To determine the efficacy and tolerability of deferasirox in the treatment of Porphyria Cutanea Tarda.

Primary objective - the elimination of all blistering within 6 months of treatment.

Secondary objective - decrease in total body iron levels.

Phlebotomy is the standard therapy for Porphyria Cutanea Tarda (PCT), but it can be inconvenient and cause anemia in some patients.

Deferasirox is a new class of tridentate iron chelators with high affinity and selectivity for iron. The medication is administered orally, which if effective for PCT would make it a more convenient and possibly more tolerable option for patients.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Porphyria Cutanea Tarda based on clinical exam and 24-hour urine porphyrin levels
* have Porphyria Cutanea Tarda for at least 3 months prior to enrollment with active blistering (3 blisters or erosions per month)
* women of childbearing potential must use an effective method of contraception during the study, however this cannot include hormonal contraception (oral contraceptives, hormone patches, Depo-Provera injections, NUVA Ring, etc.)
* treatment naive patients or patients unresponsive or intolerant of phlebotomy
* Ferritin level is greater than or equal to 25ng/mL

Exclusion Criteria:

* patients with serum creatinine above the upper limit of normal
* patients receiving phlebotomy who are controlled on this therapy
* pregnant or breast feeding females
* patients with liver transaminases more than 5 times the upper limit of normal
* patients with a history of hypersensitivity to deferasirox
* patients with a history of pre-existing renal condition, or receiving medication that depresses renal function
* patients on other chelators
* history of non-compliance to medical regimens.
An Efficacy and Safety Study of Periarticular Parecoxib Sodium for Pain Management in Total Knee Arthroplasty

Primary Research Objective:

The primary objective of this study is to determine efficacy of periarticular parecoxib sodium in a multimodal cocktail versus intravenous parecoxib injections for pain management in total knee arthroplasty

Secondary Research Objective:

* To determine if perioperative use of parecoxib sodium was associated with improved clinical outcomes
* To evaluate the safety, in terms of adverse events; serious adverse events and tolerability of parecoxib sodium in periarticular injections in a multimodal cocktail

This is a multi-center, open label, parallel randomized trial designed to evaluate the efficacy and safety of periarticular parecoxib sodium compared to intravenous parecoxib sodium.

125 patients with primary knee osteoarthritis from 4 participating sites who meet inclusion/exclusion criteria will be enrolled into the trial. After initial screening, patients will attend clinic for baseline examination. Subjects will then randomly allocated to periarticular parecoxib sodium or intravenous sodium in ratio of 1:1. patients are observed at post-operative 6, 12, 24 hours, subsequently daily for 4 days and finally at 2 week follow-up

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary knee osteoarthritis on treatment and planned for unilateral total knee arthroplasty and on spinal/general anesthesia
* Subjects age more than 50 and less than 85 years
* Patients with body weight at least 50 kg and not more than 50%above ideal body weight
* Written informed consent obtained from patient or guardian

Exclusion Criteria:

* Female patients who are attempting to conceive/pregnant
* Known allergy or hypersensitivity to cocktail regime or to COX-2 inhibitors
* History of bleeding disorders or coagulation defect
* Patients with abnormal liver profile
* Patients with history of stroke or major neurological defect
* Patients with neuropathic pain/sensory disorder
* Patients with peptic ulceration or anticoagulant use within 1 month
* History of previous major knee surgery/trauma
* Patients with renal insufficiency
* History of revision total knee arthroplasty
* Patients with knee deformity \> 20 degrees
* Patients planned for bilateral knee arthroplasty during the same setting
* Patients with significant bone loss requiring augmentation
* Patients with history of using NSAIDs 24 hours before the surgery
Bipolar RFA Using Twin ICW Electrodes vs. Switching Monopolar RFA for Recurrent HCC

This study was conducted to provide preliminary data for the main trial to compare efficacy between bipolar radiofrequency ablation (RFA) using twin internally cooled-wet electrodes and switching monopolar RFA using separable clustered electrodes in the treatment of recurrent hepatocellular carcinoma (HCC) after locoregional treatment.


Eligibility Criteria:
Inclusion Criteria:

* radiologic or pathologic diagnosis of HCC recurrence after locoregional treatment
* HCC nodules measuring 1 cm or larger and smaller than 5 cm

Exclusion Criteria:

* more than three HCC nodules
* tumors with major vascular invasion or abutment to the central portal or hepatic vein with a diameter \> 5mm
* extrahepatic metastasis
* Child-Pugh class C
* severe coagulopathy (platelet cell count of less than 50,000 cells/mm3 or prothrombin time international normalized ratio (PT-INR) prolongation of more than 50 %)
A Study of Safety and Efficacy Comparing ABT-874 Versus Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis

This study is being conducted to compare the efficacy of ABT-874 versus Methotrexate in subjects with moderate to severe plaque psoriasis.

This study is only being conducted in the EU and Canada

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Psoriasis for 6 MO.. BSA 10%, PASI 12 or above, PGA 3 or above

Exclusion Criteria:

* Previous exposure to anti-IL 12
Improving HIV Prevention Among Heterosexual Cisgender Men Seeking STI Services in Malawi

To evaluate the potential benefit(s), acceptability, and associated costs of a systems navigator-delivered HIV prevention intervention in promoting and supporting persistent use of evidence-based HIV pre-exposure prophylaxis (PrEP) among heterosexual cisgender men receiving care for sexually transmitted infections (STIs) in Lilongwe, Malawi.


Eligibility Criteria:
Inclusion Criteria:

1. Cisgender adult and adolescent cisgender men who meet all of the following criteria are eligible for inclusion in this study as a participant initiating PrEP:

   * Age ≥18 years, or age 15-17 (with assent and parent/guardian consent)
   * Able to provide informed consent
   * No plans to move outside study area for at least 26 weeks after study enrollment
   * Willing to provide contact/locator information, including phone number, to facilitate tracing
   * Willing to participate in study activities, including specimen collection
   * Willing to participate in study activities, including systems navigation, counseling, and point of contact STI testing
   * Sought STI clinic services within 7 days of enrollment
   * Initiated on PrEP at STI clinic within 7 days of enrollment
   * Reports at least one cisgender female sex partner in the 6 months prior to enrollment
   * Self-identifies as heterosexual
2. Individuals who meet all of the following criteria are eligible for inclusion in this study as other key stakeholders:

   * Age ≥18 years at the enrollment visit
   * Able to provide informed consent
   * Involved in provision of clinical service navigation, systems navigation, STI or HIV care or prevention (including clinic management or oversight), or development of HIV prevention policy or programs at local or national level

Exclusion Criteria:

1. Cisgender adult and adolescent men who meet any of the following criteria are ineligible for inclusion in this study as a participant initiating PrEP:

   * Appearance of psychological disturbance or cognitive impairment that would limit the ability to understand study procedures, as determined by the investigators
   * Any other condition that, in the opinion of the investigators, would make participation in the study unsafe, or otherwise interfere with the conduct of the study
   * Current participation in any HIV prevention study or other study considered to interfere the interpretation of study outcomes (see Section 4.4).
2. Individuals who meet any of the following criteria are ineligible for inclusion in this study as other key stakeholder:

   * Appearance of psychological disturbance or cognitive impairment that would limit the ability to understand study procedures, as determined by the investigators
   * Any other condition that, in the opinion of the investigators, would make participation in the study unsafe, or otherwise interfere with the study activities
Safety and Tolerability Study of MBS2320 in Healthy Subjects and Subjects With Rheumatoid Arthritis

Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent of patients don't respond to current treatments. MBS2320, the drug being tested in this trial, represents a new approach to treating RA, with the potential not only to reduce levels of inflammation but to also directly inhibit bone damage.The aim of this study is to test the safety of MBS2320 in healthy volunteers, to find out how MBS2320 levels change in the blood with dose, and to test the safety and compatibility of giving MBS2320 to patients with RA in combination with an existing treatment, methotrexate.

The study will be conducted in 4 parts (parts A to D). The principal aim of this study is to obtain safety and tolerability data when MBS2320 is administered orally as single and multiple doses to healthy subjects (parts A to C). The effect of MBS2320 on the pharmacokinetics (PK) of the first-line rheumatoid arthritis (RA) therapy, methotrexate (MTX), and the effect of MTX on the PK of MBS2320, will also be evaluated in a cohort consisting of subjects with RA (Part D).

Eligibility Criteria:
Principal Inclusion Criteria:

Parts A, B, and C.

* Healthy males or females between 18 and 60 years of age.
* A body mass index (BMI) between 18.0 and 30.0 kg/m2.
* Female subjects will be of non-childbearing potential or postmenopausal as defined by the protocol.
* Female subjects must not be pregnant.

Part D

* Subjects will be otherwise healthy males or females with a diagnosis of RA between 18 and 70 years of age.
* Subjects will have a BMI between 18.0 and 30.0 kg/m2.
* Female subjects must not be pregnant.
* Subjects must have been treated with, and tolerated, oral or subcutaneous MTX for a minimum of 3 months prior to screening entry.

Principal Exclusion Criteria:

Parts A, B, and C.

* Male subjects who do not agree to use appropriate contraception.
* Female subjects who are receiving HRT who do not agree to use appropriate contraception.
* Subjects who have donated blood in the 3 months, plasma in the 7 days or platelets in the 6 weeks prior to screening.
* Subjects who consume more than the permitted alcohol requirement, who have a significant history of alcoholism or drug/chemical abuse.
* Subjects who are unwilling to abstain from alcohol as required.
* A positive urine drug screen, alcohol breath test at screening or first admission.
* Subject has received a live virus vaccination within the 30 days prior to first dose administration.
* Subjects with a positive test for tuberculosis.

Additional Part D Exclusions

* Subjects who have received any medication (except MTX) known to chronically alter drug absorption or elimination processes within 30 days prior to the first dose administration.
* Subjects currently taking any medications other than those allowed per protocol guidelines.