cyrilzakka/clinical-trials huggingface dataset:
INSPIRIS RESILIA Aortic Valve, Valve-in-Valve Surveillance Study

The primary objective of the INSPIRIS RESILIA Aortic Valve-in-valve (ViV) Surveillance Study ("the Study") is to capture Adverse Event information and valve measurement data from dysfunctional INSPIRIS RESILIA aortic valves before and after Valve-in-valve (ViV) treatment.

This is a single-arm observational study which includes both prospective and retrospective data.

At least fifty (50) Subjects enrolled prospectively prior to the ViV procedure, or retrospectively after the ViV procedure (within 37 days post-ViV procedure) with dysfunctional 19mm-25mm INSPIRIS aortic valves, will participate in this study.

All subjects will be followed for up to 1 month after the TAVR ViV procedure.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following Inclusion Criteria:

1. 18 years or older at the time of the TAVR ViV treatment
2. Has an INSPIRIS RESILIA aortic valve implanted in the aortic position confirmed to be size 19mm, 21mm, 23mm or 25mm
3. A ViV procedure using an Edwards transcatheter aortic heart valve (TAVR) has been scheduled; or completed within 37 days from time of consent
4. The participant agrees to attend a follow-up assessment at 1 month post ViV procedure
5. The participant provides written informed consent prior to the post-ViV procedure CT scan

Exclusion Criteria:

Subjects must not meet any of the following Exclusion Criteria:

1. The INSPIRIS RESILIA aortic valve size is

   * Unconfirmed, or
   * Confirmed to be 27mm or 29mm
2. Prior re-interventions have been performed on the INSPIRIS RESILIA aortic valve
3. The INSPIRIS RESILIA aortic valve has been subjected to balloon aortic valvuloplasty (BAV) prior to the baseline quantitative area measurement of the valve area
4. The Subject is pregnant or desires to become pregnant within 40 days of the ViV procedure
5. Subjects with a known contraindication or hypersensitivity to contrast media that cannot be adequately pre-medicated per hospital guidelines
The Effect of Severe Weight Loss and Protein Intake on Bone

The purpose of this study is to learn whether the amount of dietary protein can influence bone health during the weight loss after weight loss surgery.

It is unclear whether the amount of protein in the diet during caloric restriction influences bone density. This information is important for determining optimal nutrient requirements during weight loss. This study will examine usual and higher dietary protein intake during severe weight loss following weight loss surgery on bone turnover, mass and quality in women, with the hypothesis that higher protein intake will reduce bone turnover and loss, and/or prevent the changes in bone quality associated with severe weight loss in women ages 18 to 70 years.

Participants will be randomly assigned to one of 2 groups: A) weight loss with recommended level of protein intake, or B) weight loss with higher protein intake. A dietitian will provide instructions for a reduced calorie, well balanced diet throughout the 12-month study using a nutrition-education behavior- modification program. Participants will have the opportunity to speak with the dietitian about their diet by phone, or on-site twice per month. In addition they will be asked to take a daily vitamin/mineral supplement and, depending on their usual food intake, they may be asked to take a calcium tablet to meet the recommended intake throughout the study period. Bone, mineral, protein and lipid markers, and hormones that influence bones will be measured. These measurements will provide information about body composition (fat, muscle mass, and bone mineral density).

Eligibility Criteria:
Inclusion Criteria:

* Women ages 18 to 70 who are undergoing gastric bypass surgery
* Must live in the geographic vicinity of Rutgers University

Exclusion Criteria:

* Currently on any medication known to influence calcium or bone metabolism, including HRT, or with evidence of diseases known to influence calcium metabolism (i.e. metabolic bone disease, hyperparathyroidism, untreated thyroid disease, significant immune, hepatic, or renal disease, significant cardiac disease \[i.e., heart attack or stroke in the past 6 months., abnormal EKG\], active malignancy or cancer therapy within the past year)
* History of kidney stones
* Weight gain or weight loss (5% of body wt) within 3 months prior to recruitment
* Participation in other investigational studies during the 12-month study period
* Usually have a very high or low intake of calcium (more than 1500 or less than 500 mg per day)
Accuracy of Implant Placement for Patients With Mandibular Reconstruction Using Dynamic Navigation and Static Guides

To evaluate and compare the accuracy of implant placement using dynamic navigation technique versus static template technique in patients with bone tissue flap reconstruction of mandibular defects, thus further guiding the clinical application of dynamic navigation systems to assist in conventional implant placement in patients with mandibular defects.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients between the ages of 18 and 70 (inclusive)
* Mandibular defects (including Class I defects, limited to the body of the mandible; Class II defects, muscular-mandibular region defects and Class III defects, chin protrusion-muscular-mandibular region defects), which have been reconstructed by mandibular vascularization of free iliac bone, and fibular composite muscular flap grafts for greater than 3 months
* Normal mouth opening (≥ 40 mm)
* Trialists voluntarily signed an informed consent form before performing any research-related experimental steps.

Exclusion Criteria:

* Presence of localized inflammation in adjacent teeth, including uncontrolled periodontitis (periodontal probing to a depth of \>4 mm)
* Presence of untreated acute and chronic apical periodontitis in adjacent teeth
* Oral mucosal lesions (e.g., lichen planus)
* Adjacent teeth with space-occupying lesions (including cysts, tumors, etc.)
* Systemic diseases affecting bone healing, wound healing and dental implant treatment (e.g., uncontrolled diabetes mellitus, fasting blood glucose ≥ 8.8 mmol/L despite medication)
* Uncontrolled and unstabilized severe hypertension
* Contraindications to routine implant surgery and oral surgery
* Heart disease (Class II or above)
* Patients with liver or kidney insufficiency or abnormality
* Obese patients with body mass index (BMI) \> 28 kg/m2
* Patients with a history of full-dose radiotherapy, localized radiotherapy to the head or neck
* Patients requiring long-term high-dose steroid therapy
* Patients who are receiving or have received in the last 3 months medications (e.g., bisphosphonates) that may affect or promote bone metabolism
* Consecutive antibiotic therapy or chronic anti-inflammatory therapy (≥3 times per week) within the first 4 weeks of starting the procedure
* Alcohol or chronic substance abuse
* Immunocompromised patients
* Smoking/tobacco equivalents/chewing tobacco \>10 cigarettes per day
* Physical or mental impairment that interferes with the performance of oral hygiene care
* Female patients who are pregnant or breastfeeding
* Patients who, in the opinion of the investigator, have poor compliance and cannot participate in the trial
* Patients who have participated in a clinical trial of another drug or device within 30 days prior to the start of the procedure (Study Day 0)
Echinacea Purpurea and Osteopathy in Children With Recurrent Otitis Media

This study was designed to evaluate the efficacy of the herb Echinacea purpurea and of cranial osteopathic manipulative treatment to prevent otitis media (middle ear infections) in young children.

The use of complementary and alternative therapies by parents of young children remains common despite the lack of clinical trials demonstrating either the efficacy or safety of these treatments. Two of the more common complementary therapies used in young children with a history of recurrent otitis media are preparations of the herb Echinacea purpurea and cranial osteopathic manipulative treatment. This study represents one of the first double-blinded, placebo controlled trials of each approach in a population of young children who presented with three or more recent episodes of acute otitis media.

Eligibility Criteria:
Inclusion Criteria:

* 3 or more separate episodes of acute otitis media within a 6 month period, or
* 4 episodes of acute otitis media in one year,

Exclusion Criteria:

* Congenital malformations of the ears, nose, or throat
* Known or suspected allergy to echinacea
* Immune deficiency including HIV infection
* Tuberculosis
* Current use of prophylactic antibiotics
* Tympanostomy tubes in place
* Unwillingness of child to participate
Effect of Terlipressin on the Incidence of Early Postoperative Acute Kidney Injury in Liver Transplantation Patients

The goal of this clinical trial is to evaluate the effect of intraoperative terlipressin on the incidence of early postoperative acute kidney injury in deceased doner liver transplantation. Patients were randomly divided into experimental group and control group by numerical randomization table. The experimental group was injected with terlipressin perioperative and the control group was injected with placebo

acute kidney injury is a relatively common complication in patients with liver transplantation. Most centers have established prediction models for acute kidney injury after liver transplantation, but the incidence cannot be reduced through perioperative anesthesia management. As an vasopressin receptor agonist, terlipressin can increase blood pressure and improve kidney perfusion at the same time, and perioperative application may reduce the incidence of postoperative acute kidney injury

Eligibility Criteria:
Inclusion Criteria:

* 1) Patients who plan to undergo liver transplantation in our hospital 2) Patients or family members sign informed consent

Exclusion Criteria:

* Patients \<18 years old;② Patients undergoing autologous liver transplantation or combined transplantation;③ Patients with lower extremity artery stenosis;(4) Patients with severe heart disease、lung disease、kidney disease;⑤ Patients with severe lung disease;⑥ Patients who used renal replacement therapy before surgery;⑦ the depth of one kidney from the body surface is greater than 4cm;⑧ Patients treated with terlipressin within 2 weeks before surgery⑨ Patients allergic to terlipressin.
High Sensitivity Cardiac Troponin T in Patients With Atrial Fibrillation Admitted to an Emergency Department (ED)

The purpose of this study was to collect data on the prevalence and clinical significance of elevated cardiac troponin in a large registry of unselected patients with atrial fibrillation presenting to an emergency department.


Eligibility Criteria:
Inclusion Criteria:

* documented atrial fibrillation in admission EKG or diagnosis of atrial fibrillation at admission.

Exclusion Criteria:

* no patients are excluded.
Clinical Trial of YHD1119 in Patients With Peripheral Neuropathic Pain

A Randomized, Double-blind, Active-Controlled, Multi-center, Phase 3 Trial to Compare the Safety and Efficacy between YHD1119 and Pregabalin in Patients with Peripheral Neuropathic Pain


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* HbA1c ≤ 9.5% diabetes mellitus patients with pain over 6 months in Diabetic Peripheral Neuropathy or postherpetic Neuralgia patients at least 3 months pain after diagnosis of skin rash due to herpes zooster

Exclusion Criteria:

* Have Brittle diabetes mellitus
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524) After Dosing for a Second Season in Children

The primary objective of this study was to determine the effect on immune reactivity to motavizumab (MEDI-524) of monthly intramuscular (IM) doses of motavizumab (MEDI-524) administered for a second season in children.

This was a Phase 1/2, randomized, double-blind study in which motavizumab (MEDI-524) or palivizumab was administered to children who previously participated in MI-CP104. Children who received at least 3 doses of motavizumab in MI-CP104 were eligible for enrollment. Subjects were randomized 1:1 to receive motavizumab or palivizumab at 15 mg/kg by IM injection every 30 days for a total of 4-5 injections during the 2004-05 RSV season subsequent to the season in which they were participants of MI-CP104. All subjects were evaluated prior to and 30 minutes after each injection of study drug with 2 follow-up evaluations, one at 30 days and the other at 90-120 days after the last dose.

Eligibility Criteria:
Inclusion Criteria:

* Previous participation in MI-CP104 and received at least 3 injections of MEDI-524 in MI-CP104
* The child must be less than or equal to 24 months of age at time of entry into the study (child must be entered on or before their 24-month birthday)
* The child must be able to complete the follow-up visits through 3-4 months after last dose (total length of participation of 6-8 months)
* Written informed consent obtained from the patient's parent(s) or legal guardian

Exclusion Criteria:

* Currently hospitalized
* Receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including continuous positive airway pressure \[CPAP\])
* Evidence of infection with hepatitis A, B, or C virus
* Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection
* Suspected serious allergic or immune mediated events with prior receipt of MEDI-524
* Acute illness or progressive clinical disorder
* Active infection, including acute respiratory syncytial virus (RSV) infection at the time of enrollment
* Previous reaction to IGIV, blood products, or other foreign proteins
* Have ever received palivizumab
* Received within the past 120 days or currently receiving immunoglobulin products (such as RSV-IGIV \[RespiGam(R)\], IVIG), or any investigational agents (except MEDI-524)
* Currently participating in any investigational study
Intubating Video Stylet Versus Fiberoptic Intubating Bronchoscope.

the video stylet (VS), it is considered one of the newer devices in this category. It is a portable device with liquid crystal-display module screen for visualization of vocal cords. It is considered an alternative to the flexible fiberoptic endoscope especially in the developing countries where the device cost is the main limiting factor. It has many benefits such as being light weight, easy to clean, durable, chargeable, less expensive and reusable. However newer video stylet devices have not been formally evaluated for tracheal intubation in case of laterally positioned patients.

Following approval from Ethics and Research Committee of Theodor Bilharz Research Institute, the study protocol will be explained to the patients after taking their consent.

Upon arrival to the operating room, a 20 G cannula will be sited intravenously and infusion of Ringer's solution will be started. Intravenous midazolam in a dose of 0.05 mg/ Kg will be given. Then, a five-lead electrocardiogram (GE-Datex Ohmeda 5 lead ECG cable), a pulse oximeter (GE- Datex Ohmeda adult finger spO2 sensor) and a non-invasive blood pressure monitor (GE-Datex Ohmeda NIBP cuff, adult double tube with bag) will be attached to the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patient age 18- 60 years.
* Both sexes
* American Society of Anesthesiologists(ASA) physical status classes I and II.
* Non-obese patients ( BMI \<35)

Exclusion Criteria:

* Difficult intubation; mallampati 3 or 4, Dental abnormalities, Cervical spine pathology that limits neck mobility , obese patients ( BMI ≥ 35) .
* Cardiovascular disease, hypertensive patients, Pregnant and nursing women, High risk of pulmonary aspiration.
* Patients at risk of bleeding either impaired bleeding profile or receiving anticoagulants
Calcium Hydroxide Versus Premixed Bioceramic Putty in Direct Pulp Capping of Primary Molars

The trial will be conducted to evaluate and compare calcium hydroxide and premixed bioceramic putty regarding the clinical and radiographic outcomes of direct pulp capping in primary molars.

The current equivalent parallel randomized controlled trial will be conducted to evaluate and compare calcium hydroxide and premixed bioceramic putty regarding the clinical and radiographic outcomes of direct pulp capping in primary molars over a 24-month follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* 1. Clinical:

  1. Children categorized as class I or II according to American Society of Anaesthesiologists (ASA) scale.
  2. Children rated as no. 3 or 4 in Frankl behaviour rating scale (FBRS).
  3. Presence of a small carious or traumatic pulp exposure (1 mm or less). 2. Radiographic:

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  1. Presence of at least two-thirds of root length.
  2. Normal lamina dura and periodontal ligament space.

Exclusion Criteria:

* 1. Clinical:

  1. History of spontaneous unprovoked toothache.
  2. Extensive crown destruction that preclude coronal restoration.
  3. Gingival swelling, sinus tract or other soft tissue pathology.
  4. Abnormal tooth mobility.
  5. A frank pulp exposure (i.e., greater than 1.0mm), requiring pulpotomy.
  6. No evidence of visible pulp exposure.

     2. Radiographic:

  <!-- -->

  1. Furcation/periapical radiolucency.
  2. Pathological internal/external root resorption.
  3. Absence of underlying permanent successor
Cognitive Function in Melanoma Patients Treated With Adjuvant Immune Checkpoint Inhibitors

Immune checkpoint inhibitors (ICIs) are a group of novel immunotherapies that boost the body's own defense against the cancer by improving the immune system's ability to recognize and destroy cancer cells. While it is relatively well-documented that conventional cancer treatments (e.g., chemotherapy) are associated with cognitive impairment, virtually nothing is yet known about effects on cognition during and after ICI treatment. Due to significantly improved survival rates after ICI treatments, it becomes important to map possible adverse effects associated with these treatments. The investigators therefore investigate possible changes in cognitive function in a group of cancer patients from prior to ICI treatment to nine months later. A gender- and age- matched healthy control group will serve as a comparison. The study has the potential to broaden our understanding of associations between cognition, the brain, and the immune system and to provide clinically relevant knowledge about possible cognitive impairments associated with immunotherapy.

This controlled prospective observational study will include two groups with a total of 84 participants. A total of 42 patients diagnosed with melanoma, referred to treatment with ICI will be enrolled in the study and examined prior to treatment with ICI (baseline), at eight weeks following baseline (T2), at 24 weeks following baseline (T3) and 12 weeks after treatment completed (T4). A total of 42 gender- and age- matched healthy controls will be included and assessed at similar time points. Assessments will include a battery of neuropsychological tests, questionnaires, blood samples, and Magnetic Resonance Imaging (MRI).

The main objectives of the study are to investigate:

1. Changes in cognitive functions over the course of treatment with ICIs.
2. Possible associations between changes in cognitive function and immune markers during and following ICI treatment.
3. Possible associations between changes in cognitive function and changes in brain morphology.
4. Changes over time in other possible adverse effects of ICI treatment, including psychological distress, sleep disturbances, and fatigue.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of melanoma and scheduled for ICI treatment at Aarhus University Hospital (AUH), Denmark. The healthy control group will consist of an age- and gender- matched sample of participants.

Exclusion Criteria:

* Previous treatment with immunotherapy
* Neurodegenerative diseases (dementia etc.)
* Substance abuse
* Known progressive psychiatric diseases (e.g., Schizophrenia)
* Other confirmed diagnoses with underlying cognitive impairment
* Insufficient Danish proficiency
Significance of Synbiotics on Inflammation and Proliferation of Colonic Mucosa

There is a constant exchange between the gut epithelium and lumen, including microbial interplay. The aim of this study was to investigate dietary test products on inflammatory proliferation markers in the gut, and thereby if the products had positive effects in the gut as well as in other parts of the body.

The hypothesis was that the test products would reduce the inflammatory and proliferation activity of the gut epithelium by fermentation of normal food products and by converting dietary phenolic compounds into anti-inflammatory substances.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old,
* Able to understand oral and written information,
* Informed consent

Exclusion Criteria:

* Ongoing immune suppressive treatment, incl. cortisone,
* Ongoing antibiotic treatment or antibiotic treatment ended within 4 weeks,
* History of inflammatory bowel disease
Phase II Clinical Study of GemOX Hepatic Arterial Infusion Combined with Lenvatinib and Toripalimab for Advanced and Unresectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer

For advanced unresectable intrahepatic cholangiocarcinoma and gallbladder cancer, the current standard first-line treatment is a combination of chemotherapy and immunotherapy. However, the efficacy rates remain low. Hepatic artery infusion chemotherapy can reduce systemic drug dosages while increasing local drug concentrations, which is expected to enhance overall efficacy and minimize drug toxicity and side effects.

This study utilized a hepatic artery infusion chemotherapy regimen that combines gemcitabine with oxaliplatin, along with the small molecule tyrosine kinase inhibitor lenvatinib and the immune checkpoint inhibitor toripalimab. The aim was to improve treatment efficacy and create opportunities for conversion surgery. The primary endpoint was the objective response rate, while the secondary endpoints included the surgical resection rate, complete pathological response rate (pCR), overall survival (OS), and the incidence of adverse reactions.


Eligibility Criteria:
Inclusion Criteria

1. Age 18 or above
2. Histopathological or cytological diagnosis of intrahepatic cholangiocarcinoma or gallbladder cancer
3. A tumor that cannot be removed by three independent surgeons.
4. Expected lifespan ≥ 12 weeks
5. ECOG PS score 0-1 points
6. The patient voluntarily participates and signs an informed consent form;
7. Expected compliance is good, able to follow up on efficacy and adverse reactions according to the protocol requirements.

Exclusion criteria:

1. Use any systemic research anti-cancer drugs
2. Active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which may include hormone replacement therapy)
3. Asthma requires the use of bronchodilators for medical intervention
4. Congenital or acquired immune dysfunction, such as human immunodeficiency virus (HIV) infection
5. Clinical symptoms or uncontrolled heart disease
6. Severe infection within 4 weeks before the first use of medication
7. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
8. Vaccination with attenuated live vaccine within 4 weeks before treatment
9. Other systemic malignant tumors in the past 5 years