cyrilzakka/clinical-trials huggingface dataset:
GRACE - Study of AGN1 LOEP in Osteopenic and Osteoporotic Patients

The study is designed as a retrospective, single-center study for subjects previously treated with the AGN1 LOEP Kit. This will be a non-randomized and non-blinded study. The study will collect retrospective data on the safety and performance of AGN1 LOEP of all subjects treated outside of any other clinical study protocols between September 2019 and November 2022. A prospective questionnaire will be included to evaluate self-reported subject experiences.


Eligibility Criteria:
Inclusion Criteria:

* Subject has previously received AGN1 LOEP treatment between September 2019 and November 2022.
* Subject has willingness to participate in the study.
* Subject can give written informed consent to allow for data collection.

Exclusion Criteria:

* The subject's AGN1 LOEP treatment was previously performed as part of a prior protocoled clinical study.
Pilot Trial of Novel Circumcision Device

The investigators are testing a novel surgical device to facilitate safe circumcision among adult males. The investigators hypothesize that this device will allow non-medical providers to perform safe surgical circumcision without adverse events.

Objective: To conduct a proof-of-concept study to determine the potential utility of a novel, adjustable single-visit, disposable device to facilitate rapid adult circumcision.

Design: Prospective pilot trial of a novel surgical device Setting: Tertiary care Veterans Administration medical center Patients: 5 adult males Interventions: Circumcisions performed by junior trainees using an adjustable, single-size surgical-assist device constructed by the University of Washington Applied Physics Laboratory.

Main Outcome Measure(s): The attending surgeon and trainees completed standardized forms after each procedure to assess technical problems and ease of use. Follow-up visits were scheduled to evaluate adverse events, post-operative pain, cosmetic outcomes and participant satisfaction at 3, 8, 30 and 90 days post-operatively.

Eligibility Criteria:
Inclusion

1. Uncircumcised males
2. Aged\>18
3. Sexually active
4. No plans for moving in next 6 months
5. Consent to participate

Exclusion

1. History of a bleeding disorder
2. History of a documented concurrent STI of appearance of an STI on initial physical exam
3. Keloid formation or other condition that might unduly increase risk of elective surgery
4. Asprin, anti-coagulants or other clinical contra-indications
Effect of an Optimal Heart Team Protocol on Decision-making Stability

This study is aimed to evaluate the effect of the optimal heart team implementation protocol on the stability of decision-making for patients with complex coronary artery disease.

Current guidelines recommend a heart team in the decision making for patients with complex coronary artery disease (CAD). Previous study reported that the agreement between heart teams for revascularization decision-making in complex CAD patients was moderate. Potential factors associated with decision discrepancies were summarized in several aspects and a detailed heart team implementation protocol was generated and further validation is needed. This study is designed to evaluate the effect of the optimal heart team implementation protocol on the stability of decision-making for patients with complex coronary artery disease.

Eligibility Criteria:
Eligibility Criteria for patients:

Inclusion Criteria:

Patients with stable CAD according to the National Cardiovascular Data Registry (NCDR) CathPCI criteria (stable angina, no or silent myocardial ischemia) and angiographically confirmed 3-vessel disease or left main disease.

Exclusion Criteria:

1. prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG);
2. cardiac troponin I (CTnI) greater than the local laboratory upper limit of normal or recent myocardial infarction with CTnI levels still elevated;
3. concomitant severe valvular disease, macrovascular disease, or huge ventricular aneurysm requiring surgery;
4. concomitant atrial fibrillation or severe arrhythmia

Eligibility Criteria for specialists:

Inclusion Criteria for interventional cardiologists:

1. Annual PCI volume ≥200
2. Annual left main PCI volume ≥25
3. Capable of chronic total occlusion(CTO) PCI
4. Clinical researcher experience in coronary revascularization
5. Proficient in clinical guidelines

Inclusion Criteria for cardiac surgeons:

1. CABG total volume ≥200
2. Proficient in both on-pump and off-pump CABG
3. Clinical researcher experience in coronary revascularization
4. Proficient in clinical guidelines

Inclusion Criteria for non-interventional cardiologists:

1) Proficient in clinical guidelines
The Treatment of Knee Osteoarthritis With Balanced Buttress Absorbable Spacer

The investigators randomly divided the knee osteoarthritis patients met the inclusive criteria into two groups (study group and control group). Placement of balanced buttress absorbable spacer and total knee arthroplasty were conducted. The clinical outcome of two groups were compared in this study.

Knee osteoarthritis, caused by non-uniform settlement of medial and lateral tibial plateau, was not uncommon in clinic. Medial stenosis was the most type of the disease. The symptoms included knee pain during walking and varus deformity of lower limbs. Total knee arthroplasty and tibial osteotomy were two common conventional treatment of the knee osteoarthritis, which were not minimally invasive and bring great financial burden to patients' family. The investigators planned to recruit 150 patients of knee osteoarthritis into this study, which were randomly divided into two groups (study group and control group). For the patients of study group, a balanced buttress absorbable spacer was placed into the gap after the osteotomy of tibia and fibula to modify the lower limb line. However, total knee arthroplasty was conducted for the patients of control group. The patients were followed up and the clinical outcomes were compared in this study.

Eligibility Criteria:
Inclusion Criteria:

* 40-80 years old
* Medial stenosis of the knee
* Varus deformity less than 20 degrees

Exclusion Criteria:

* Lateral stenosis of the knee
* Hepatic renal dysfunction
* Refuse to participate the study
A Study of Zilovertamab Vedotin (MK-2140/VLS-101) in Participants With Solid Tumors (MK-2140-002)

This is a study evaluating the efficacy, safety, and pharmacokinetics of zilovertamab vedotin in participants with metastatic solid tumors including previously treated cancers of triple-negative breast cancer (TNBC), non-TNBC human epidermal growth factor receptor 2 (HER2)-negative breast cancer, non-squamous non-small-cell lung cancer (NSCLC), gastric cancer, pancreatic cancer, and platinum-resistant ovarian cancer. The study will evaluate a null hypothesis that the objective response rate (ORR) is ≤5% against the alternative hypothesis that it is ≥20%.

Participants enrolled prior to Amendment 3 will receive zilovertamab vedotin at 2.5 mg/kg given intravenously on Day 1 of repeated 21-day cycles. Participants enrolled after Amendment 3 will receive zilovertamab vedotin at 1.75 mg/kg given intravenously on Day 1 and Day 8 of repeated 21-day cycles. Treatment will continue until progressive disease or discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* Has a confirmed diagnosis of solid tumor for one of the following types of cancer: previously treated cancers of triple-negative breast cancer (TNBC), non-TNBC HER2-negative breast cancer, non-squamous non-small-cell lung cancer (NSCLC), gastric cancer, pancreatic cancer, or platinum-resistant ovarian cancer.
* Has metastatic disease that has progressed during or following previous treatment appropriate for the disease type
* Presence of radiographically measurable disease.
* Is willing to provide tumor tissue
* Has adequate organ function
* Has a negative test or adequate therapy for human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C.
* Has completed all prior therapy.
* Female subjects of childbearing potential must have a negative serum pregnancy test.
* Both male and female subjects must be willing to use adequate contraception.

Exclusion Criteria:

* Has peripheral neuropathy of Grade \>1.
* Has a malignancy involving the central nervous system.
* Has another major cancer.
* Has an uncontrolled ongoing infection.
* Has significant cardiovascular disease.
* Has a known diagnosis of liver cirrhosis.
* Is pregnant or breastfeeding.
* Has had major surgery within 4 weeks before the start of study therapy.
* Has known tumor resistance or intolerance to a prior MMAE-containing drug.
* Is concurrently participating in another therapeutic or imaging clinical trial.
Comparison of Regional Block, Caudal Block and Wound Infiltration in Inguinal Hernitomy

Background: Although Inguinal herniotomy in children is taken as a day care procedure, post-operative pain management still remain controversial in these cases and superiority of wound infiltration, caudal block or regional block over each isn't known.

Objective: The objective of the study was compare regional block, caudal block and wound infiltration for post-operative pain management in children undergoing inguinal herniotomy

Three hundred patients rom the department of pediatric surgery, KEMU/Mayo Hospital, were randomized in three study groups by a computer generated table. Regional block group (Group A), wound infiltration group (Group B), caudal block group (Group C). . Patients were assessed for postoperative pain intensity using FLACC pain scale at 0, 1, 2, 4, 8, 24 hours after surgery in children less than 8 years of age. Wong-Baker Faces pain Scale at 0, 1, 2, 4, 8, 24 hours after surgery in children more than 8 years of age. Patients were discharged after 24 hours. If pain score ≥ 4 was given intravenously, Ketoralac. Urinary retention was observed after 24 hours, wound infection was observed after 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Both Male and female inguinal hernia patients
* Patients from 3-12 years age Exclusion Criteria
* History of allergy to any drugs used in study documented on history .Infection at the site of regional, caudal or local infiltration, documented on clinical examination.

.Irreducible, obstructed or strangulated hernia, documented on clinical examination.
An Open Label Study to Allow Patients Continuous Use of the HemoCare™ Hemodialysis System

This study is designed to monitor and assess the safety of continued access to the HemoCare™ Hemodialysis System used during the review of the pre-market notifications for the devices in the HemoCare™ Hemodialysis System.


Eligibility Criteria:
Inclusion Criteria:

* Completed DEKA Protocol DKPL 00057 001 and are qualified to enter the study based on the assessment of the Investigator.
* Are willing to comply and capable of complying with the study requirements for therapy with the HemoCare™ Hemodialysis System.
* Have a trained study care partner able to support subject for all at-home study treatments.
* Subject and care partner can read and understand English and provide written informed consent.
* Have a stable functioning vascular access as judged by the treating physician.

Exclusion Criteria:

* Have a current self-reported pregnancy or are actively planning to become pregnant within the next 12 months, lactating, or not using medically acceptable means of contraception during the study.
* Have any any other clinically significant medical disease or condition or subject responsibility that, in the Investigator's opinion, may interfere with a subject's (and/or care partner's) ability to give informed consent, adhere to the protocol, interfere with assessment of the investigational product (IP), or serve as a contraindication to the subject's participation in the study.
* Have a significant psychiatric disorder or mental disability that could interfere with the subject's ability to provide informed consent and/or comply with study procedures.
* Are participating or planning to participate in any other interventional studies except DKPL-00057-001.
Home Versus Hospital Based Action Observation Therapy in Diaplegic Cerebral Palsy

Effects of Home Versus Hospital Based Action Observation Therapy on Balance, Mobility and Cognition in Diaplegic Cerebral Palsy. It will be a RCT we want to identify the effects of action observation therapy on patients coming to the hospital as compared to the patients at home. We will also identify the retaining effects of AOT. Our sample size will be 40 diplegic patients having no cognitive issues and able to walk with assistive device. We will exclude the patient who will suffer with severe comorbidities and visual impairment. We will randomly assign the patients into two groups A and B.A will receive Action observation therapy three times a day along with stretching exercises .while group B we perform AOT and stretching exercises at home with same frequency.


Eligibility Criteria:
Inclusion Criteria:

* Participants falling in this category will be recruited into the study.

  * Diagnosed Diaplegic CP Children between the age of 5 to 11 years.
  * Without visual impairment and visual field defects.
  * Able to follow the researcher's instruction.
  * GMFCS (gross motor function classification system) level I-III.

Exclusion Criteria:

* Participants failing to fall in this category will be excluded of the study.

  * Children with a Modified Ashworth scale (MAS) of 3 or more
  * Unable to walk
  * Children with severe co-morbidities. (2)
Influenza Vaccine in Lung Transplant Patients - Persistence of Antibodies

This a sub-study of a 5-year study designed to investigate how antibody and T cell responses following influenza vaccine compare among lung transplant patients, patients waiting for lung transplantation, and healthy individuals.

This study is designed to investigate influenza vaccine-induced antibodies in lung transplant patients between seasons.

In the recent past, immunization policy-making bodies advised against immunizing too early in the influenza season because vaccine-specific antibody may wane before the end of the influenza season. This recommendation was based on only a small amount of data in frail elderly individuals, and further examination of the evidence shows that influenza vaccine antibody may last much longer. The influenza immunization timing recommendation is now changed to immunize when vaccine is available and continue throughout the season.

These changes led the investigators to the question of duration of influenza vaccine-induced antibody in lung transplant patients. No published studies of antibody persistence in this population could be found.

As part of a 5-year study of influenza antibody response in lung transplant patients, in patients awaiting lung transplantation, and in healthy controls, serum was obtained before and 2-4 weeks after influenza immunization for each season. Therefore, a serum sample was collected on each participant approximately 11 months after influenza vaccine administration for each of 4 years.

To investigate duration of influenza antibody titers, antibody concentrations to the previous season's vaccine antigens were measured.

The hypothesis is that immunosuppressed lung transplant patients would maintain protective concentrations of influenza antigen-specific antibodies (an antibody titer of at least 1:40) beyond the influenza season.

\[This substudy that was originally registered to NCT00205270 and subsequently registered to its own NCT number for the purpose of clarity in linked results\]

Eligibility Criteria:
Inclusion Criteria:

* Receiving care pre- or post-lung transplant at University of Wisconsin Hospital
* Healthy adult

Exclusion Criteria:

* Allergy to eggs
* Moderate to severe febrile illness
* Active treatment for acute rejection
* Received season's influenza vaccine prior to enrollment
Gait Metric Validation of the Cionic Neural Sleeve

The purpose of this study is to determine the validity of the Neural Sleeve gait metrics compared to gait parameters assessed with a Protokinetics Zeno pressure sensitive walkway. The spatiotemporal gait parameters obtained from the Zeno walkway have been rigorously validated and will represent the "gold standard" ground truth measurements in the proposed protocol. Confirming the validity of the Neural Sleeve metrics offers benefit to individuals who utilize the device by providing confidence that calculated gait reports are accurate and can be used to inform usage of the device and associated gait changes over time. Findings of innaccuracy would still offer benefit in the form of knowing that the Neural Sleeve metrics need to be used with caution and/or updated to provide correct outcomes to users.

The study aims to validate the gait metrics of the Neural Sleeve in healthy adult volunteers. All participants will wear a Neural Sleeve on their dominant leg. The Zeno pressure gait mat will be laid flat on the ground and used for all walking conditions. Overall, participants will perform three, 5 minute walking bouts without electrical stimulation. Two walking conditions will be performed while wearing the Neural Sleeve, however, no electrical stimulation will be utilized. The movement sensors on the Neural Sleeve will collect motion data that permits the comparison of gait metrics from the Sleeve to those measured by the gait mat. During the walking trials participants will be told that they can take a break if needed. Condition order will be randomized and participants will be offered 5 minutes of rest between consecutive trials. Validity of gait metrics of the Neural Sleeve will be compared against the Zeno walkway.

Eligibility Criteria:
Inclusion Criteria:

* Persons between the ages of 22-64
* Ability to ambulate at least 30 minutes during a two hour period

Exclusion Criteria:

* Lower motor neuron disease or injury (e.g. peripheral neuropathy)
* Absent sensation in the legs
* Demand-type cardiac pacemaker or defibrillator
* Malignant tumor in the legs
* Existing thrombosis in the legs
* History of lower limb injury or orthopedic issues leading to impaired walking
Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab

Determine the plasma concentration profile after single and multiple dosing of Sufentanil NanoTabs


Eligibility Criteria:
Inclusion Criteria:

* Non smoking
* Ages 18 to 45 year, inclusive
* BMI between 18 and 30

Exclusion Criteria:

* Subjects taking any prescription or OTC medications or vitamins or supplements
* Pregnant females
* Subjects with pulmonary disease or sleep apnea
Needle-Free Jet Injection of Lidocaine During Lumbar Puncture

Background: The J-Tip Device allows an intradermal needle-free jet injection of 1% buffered lidocaine. This study compares needle-free jet injection of lidocaine to saline in reducing pain prior to lumbar puncture in infants.

Methods: Randomized, double-blinded, placebo controlled trial involving infants, less than 3 months of age, presenting to the emergency department meeting clinical criteria for a lumbar puncture. All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture.

Background: Lumbar puncture is an essential procedure in the emergency department for the evaluation of meningitis. Subcutaneous injection of lidocaine prior to lumbar puncture for local anesthesia is not a pain free procedure. The J-Tip Device allows an intradermal needle-free jet injection of 1% buffered lidocaine. This study compares needle-free jet injection of lidocaine to saline in reducing pain prior to lumbar puncture in infants.

Methods: Randomized, double-blinded, placebo controlled trial involving infants, less than 3 months of age, presenting to the emergency department meeting clinical criteria for a lumbar puncture. All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture. Vital signs were recorded during the procedure. Facial expressions as well as crying times were video recorded from start to finish. Independent reviewers assigned pain scores based on the validated Neonatal Facial Coding System with possible scores ranging from 0-5.

Eligibility Criteria:
Inclusion Criteria:

* fever in infants less than 3 months

Exclusion Criteria:

* toxic appearance, altered level of consciousness, age greater than 3 months or less than 4kg of weight
Parecoxib in Renal Colic

This is a phase III, multicenter, randomized, single blind study designed to evaluate the efficacy and tolerability of a single dose of parecoxib compared with diclofenac in the treatment of acute pain due to renal colic.

This study was prematurely discontinued May 3, 2004 due to slow recruitment. The decision to terminate the trial was not based on any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of renal colic;
* baseline pain \> 50 mm on VAS;

Exclusion Criteria:

* evidence of neoplasm or any other severe disease of any organ, including any psychiatric illness;
* active GI disease (e.g. Crohn's disease or ulcerative colitis) or any evidence of concomitant disease which may lead to early termination of the study
A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037)

The purpose of the study is to estimate the response rate and compare overall survival of patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or Carboplatin and Paclitaxel


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Men \& women ≥ 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
* Histologically confirmed Stage III (unresectable)/Stage IV melanoma
* Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
* Objective evidence of disease progression (clinical or radiological) during or after at least 1 (V600 Wildtype) or at least 2 (V600 mutation positive) prior treatment regimens
* Pre-treatment fresh core, excision or punch tumor biopsy
* Archival Formalin-fixed paraffin-embedded (FFPE) tumor material if available

Exclusion Criteria:

* Any treatment in a BMS-936558 (Nivolumab) trial
* Subjects with condition requiring systemic treatment with either corticosteroids (\> 10mg daily prednisone/equivalent) or other immunosuppressive medications within 14 days of study drug administration
* Active, known or suspected autoimmune disease
* Unknown BRAF status
* Active brain metastasis or leptomeningeal metastasis
* Ocular melanoma
* Prior therapy with anti programmed death-1 (anti-PD-1), anti programmed death-ligand 1 (anti-PD-L1) or anti-programmed death-ligand 2 (anti-PD-L2)