cyrilzakka/clinical-trials huggingface dataset:
Benefit of Orthopedic Navigation in the ARThroplasty of the Hip

This study was initiated to investigate the impact of the computer based image free navigation on the precision of the cup implantation. The implantation of the acetabular component (cup) is known to be a critical step in hip endoprosthetics. The cup position influences significantly the function, the absence of pain and the longevity of the artificial hip joint. The image free navigation system OrthoPilot is used to control the positioning of the cup during surgery.


Eligibility Criteria:
Inclusion Criteria:

* Indication for primary cementless total hip endoprosthesis implantation with Bicontact stem and Plasmacup
* Diagnoses: primary or secondary coxarthrosis, rheumatoid arthritis, femoral head necrosis
* Age ≥ 50 Years
* ASA score \<4
* Patient signed the informed consent

Exclusion Criteria:

* Excessive damage to the hip joint (e.g. dysplasia)
* Severe deformities of the pelvis, femoral bone or knee
* Unfeasibility of landmark palpation (e.g. due to adiposity)
* Acute or chronic infection
* Pregnancy
* Patients not available for follow-up-examination at the center
* Patients exceeding 10 mSv effective radiation dose because of previous scientific or clinical exposition during the past 10 years
A Study to Evaluate the Preliminary Efficacy Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-remitting Multiple Sclerosis

The purpose of this study is to determine whether BMS-188667 will decrease multiple sclerosis disease activity on MRI examinations, as well as decrease the rate of clinical MS exacerbations, compared to placebo


Eligibility Criteria:
Inclusion

* relapsing-remitting MS
* at least 1 exacerbation in preceding 2 years
* at least 1 MRI lesion
* stable for 2 months prior to dosing

Exclusion

* progressive MS
* currently treated with an immunomodulatory therapy
* previously treated with an approved MS drug where treatment was discontinued for lack of efficacy
* active bacterial or viral infections
Early MOtion Total Ankle Artroplasty

Evaluate the clinical and radiographic results of patients undergoing total ankle arthroplasty and treated in the post-operative period in a randomized manner with early mobilization of the ankle joint or with cast immobilization for 3 weeks


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (aged between 18 and 80).
* Male or female patients;
* Signature of the informed consent for participation in the study;
* Patients prepared and motivated to comply with the scheduled follow-up visits and the completion of the study questionnaires

Exclusion Criteria:

* main diagnosis other than osteoarthritis, history of ankle infection
* need to carry out surgical interventions associated with total prosthesis ankle (e.g., calcaneal osteotomy, knee lowering osteotomy).

first metatarsal bone, supramalleolar osteotomy, etc.)

* intraoperative complications (for example a malleolar fracture) which require a different post-operative protocol
* peripheral vascular disease
* marked osteoporosis of the ankle and foot
* osteonecrosis of the talus
* neurological disorders affecting the lower limb inability to understand study information or respond to questionnaires due to cognitive or linguistic deficits
* patients who are pregnant or breastfeeding
Study to Evaluate Safety, Tolerability and Pharmacokinetics of IDB-011

Phase 1 randomized, double-blind, placebo-controlled trial to evaluate safety, tolerability, pharmacokinetics (PK) and immunogenicity of IDB-011 following intramuscular (IM )administration of single ascending doses to healthy adult participants.

This is a randomized, double blind, placebo-controlled, dose escalation, first-in-human, Phase I clinical trial to assess the safety, tolerability, PK and immunogenicity of IDB-011 in healthy volunteers aged 18-64. IDB-011 is comprised of IDB-774 and IDB-898, which will be administered as separate, consecutive intramuscular injections.

Volunteers will be recruited into sequential dosing cohorts. Within each cohort, eligible volunteers will be randomly allocated (6:2) to receive either IDB-011 or placebo (0.9% normal saline). A sentinel dosing scheme will be employed for the first 2 volunteers in each dosing cohort.

Volunteers will stay in a clinical research unit for up to 4 consecutive days and be followed for up to 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female
* Body mass index (BMI) within 18.0 kg/m2 to 30.0 kg/m\^2, inclusively
* Female participants must not be pregnant, breastfeeding or intend to become pregnant through 1 year post-administration
* Male subjects must agree to not cause pregnancy or donate sperm for 1 year post-administration
* Non-smoker
* Agree to abstain from alcohol for 72 hours and caffeine for 48 hours prior to administration and during the confinement period
* Agree to not donate blood or plasma during study participation
* Agree not to travel to Rift Valley fever virus (RVFV) endemic areas during participation

Exclusion Criteria:

* Known history of RVFV infection
* Previous receipt of RVFV vaccine
* Illness with fever within 5 days prior to administration
* History of malignancy within prior 5 years
* History of significant cardiovascular, pulmonary, gastrointestinal, liver, kidney, hematologic, neurological, psychiatric, endocrine, immunologic, dermatologic disease
* History of hypersensitivity reaction
* History or clinical evidence of alcohol abuse
* Human immunodeficiency virus (HIV) positive
* Hepatitis C virus positive
* Hepatitis B virus positive
* Received immunoglobulin or antibody product within 6 months of administration
* Vaccine within 28 days of administration
* Received investigational agent within 3 months or \< 5 half-lives (whichever is longer) prior to administration
* Donation of plasma, 1 unit or \> 500 mL blood donation in 56 days prior to administration
Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair

The objective this study is to collect post-market data on the performance of the Zenapro™ Hybrid Hernia Repair Device when used to reinforce or bridge the abdominal wall for the repair of ventral hernias.


Eligibility Criteria:
Inclusion Criteria:

* Primary or recurrent ventral hernia
* Need for abdominal wall repair with reinforcement or bridging material to obtain the desired surgical result

Exclusion Criteria:

* Age \< 21 (i.e., infants, children)
* Device intended to be used in an infected wound
* Known sensitivity to porcine material
* Pregnant or planning pregnancy in the future
* Life expectancy of less than 12 months from the date of the index procedure
* Hernia too large to be covered with a single device with at least 4-5 cm of tissue overlap on all sides
Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the mHSPC

Evaluate whether the combination of Rezvilutamide and androgen deprivation therapy (ADT) with docetaxel improves overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to the combination of Rezvilutamide and ADT.

To investigate the value of chemotherapy in the treatment of high-burden of mHSPC on the background of next-genertion of AR inhibitors.

Eligibility Criteria:
Inclusion Criteria:

1. Males aged ≥40 years and ≤80 years.
2. Histologically or cytologically confirmed prostate adenocarcinoma.
3. Metastatic disease.
4. Eligible for ADT and Docetaxel.
5. Started or not started first-generation androgen deprivation therapy (ADT), but not exceeding 12 weeks before randomization.
6. ECOG score of 0 or 1.
7. Laboratory tests meet the following requirements:

   * Hematology: neutrophils ≥1.5×10\^9/L, platelets ≥100×10\^9/L, hemoglobin ≥9g/dL.
   * Renal function: serum creatinine ≤1.5× upper limit of normal (ULN).
   * Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN, total bilirubin (TBIL) ≤1.5× ULN.
   * Coagulation function: international normalized ratio (INR) \<1.5.
8. Study subjects: Patients with mHSPC have a confirmed pathology of prostate adenocarcinoma with high tumor burden, which is defined by having at least one of the following conditions:

1) Bone scan showing ≥4 bone metastatic lesions (with at least one site outside the pelvis or spine).

2) CT/MRI revealing visceral metastatic lesions (excluding lymph nodes).

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible to participate in this study:

1. Prior use of LHRH agonists/antagonists; second-generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide (ODM-201), or other investigational AR inhibitors; CYP17 enzyme inhibitors such as abiraterone acetate or oral ketoconazole for anti-tumor treatment of prostate cancer; chemotherapy or immunotherapy for prostate cancer prior to randomization.
2. Received radiation therapy/radiopharmaceutical treatment within 2 weeks before randomization.
3. Any of the following conditions within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary artery/peripheral artery bypass surgery, congestive heart failure (New York Heart Association class III or IV).
4. Previous malignancy, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin or superficial bladder cancer not invading the deeper muscle layer (i.e., pTis, pTa, and pT1) and any other cancer in complete remission for at least 5 years before randomization.
5. Gastrointestinal diseases or procedures that are expected to significantly interfere with the absorption of study treatment.
6. Inability to take oral medication.
Supportive Oncology Care at Home for Patients With Pancreatic Cancer Receiving Preoperative FOLFIRINOX

The goal of this research is to study an intervention, which the investigators call "Supportive Oncology Care at Home," that entails both remote patient monitoring (e.g. patient-reported symptoms, home monitored vital signs, and body weight) and a Medically Home care model (e.g. triggers for phone calls and visits to patients' homes to address and manage any concerning issues identified). Specifically, the investigators will conduct a single arm pilot study (N=20) in patients with pancreatic cancer who sign consent for parent trial of neoadjuvant FOLFIRINOX (18-179) receiving preoperative FOLFIRINOX to assess the feasibility and acceptability of Supportive Oncology Care at Home.

Preoperative treatment can cause significant morbidity and often result in hospitalizations. Patients receiving preoperative FOLFIRINOX often experience numerous side effects, including nausea, vomiting, diarrhea, fatigue, fever, neuropathy, and loss of appetite. Frequently, patients require hospital admissions to help address uncontrolled symptoms related to their cancer and side effects related to the treatment,

Interventions targeting patients' symptoms and delivering care to patients at their homes have the potential to improve patient outcomes. Studies show that interventions targeting patients' symptoms can improve symptom management, enhance quality of life (QOL), and prevent hospitalizations.

Medically Home interventions have shown the potential to enhance patient outcomes. The Medically Home model of care is an alternative to a hospital admission for acute care and treatment of a clinical condition. Medically Home interventions entail providing medical care to acutely ill patients in their home. In addition, research in the general medicine literature has demonstrated that interventions involving remote patient monitoring with 'triggers' for visits to patients' homes for worrisome symptoms can enhance care outcomes.

Although this research demonstrates promising results, these studies have not been conducted among patients with cancer. Notably, the prior work involving home monitoring with visits as needed has lacked patient-reported outcomes, such as symptom monitoring. Thus, efforts are needed to develop and test interventions containing both symptom monitoring and the potential for home visits when necessary in a population of patients with cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Within three weeks of signing consent for parent trial of neoadjuvant FOLFIRINOX
* Planning to receive care at Massachusetts General Hospital
* Ability to read and respond to questions in English
* Residing within 50 miles of Massachusetts General Hospital

Exclusion Criteria:

-Uncontrolled psychiatric illness or impaired cognition
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of VSA003 in Chinese HoFH Patients

Significant reduction in ANGPLT3 levels is expected to reduce plasma LDL-C and TG levels and may lead to the reduction of risk of coronary heart disease and cardiovascular events associated with hypertriglyceridemia and LDL-C in subjects with persistent dyslipidemia. In this clinical study, the efficacy and safety of VSA003, an RNAi-based therapeutic targeting ANGPTL3, will be evaluated in subjects with HoFH.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥ 12 years and weighing ≥ 40 kg at the time of ICF signature;
* Patients with HoFH who meet genetic or clinical diagnosis;
* Willing to follow a daily low-fat diet for the duration of the study;
* Receiving stable and tolerable lipid-lowering therapy prior to LDL-C testing during the screening period;
* Fasting LDL-C ≥ 2.6 mmol/L.

Exclusion Criteria:

* Have received or are receiving targeted ANGPTL3 treatment within 5 months or 5 half-lives, whichever is longer, prior to screening;
* Fasting TG ≥ 4.5 mmol/L at screening;
* Presence of uncontrolled endocrine disease affecting lipids or lipoproteins;
* Weight change of more than 10% in the 4 weeks prior to randomisation;
* Initiation of a new dietary plan or significant differences from previous dietary structure and habits within 4 weeks prior to screening;
* Women who are pregnant (including planned pregnancies) or breastfeeding;
* Refusal to limit alcohol consumption to moderate limits and below during the study period, specifically no more than 14 units per week;
* Uncontrolled hypertension (blood pressure \> 160/100 mmHg at screening);
* New York Heart Association (NYHA) class IV heart failure or left ventricular ejection fraction \<30% within 12 months prior to screening;
* History of major surgery within 12 weeks prior to baseline, or planning to undergo major surgery during the study;
* Known allergy to any component of the study drug.
Effects of Low Intensity, High Intensity Eccentric Resistance Training Associated With Blood Flow Restriction

Introduction: studies on resistance training of low intensity associated with blood flow restriction in recent years, although there are still gaps that can be explored in relation to their physiological phenomena when associated with eccentric training. In this way, from there the exploration becomes relevant the investigation of eccentric training associated to an RFS. Objective: To analyze and compare the effects of a high intensity and low intensity intensive resistance training associated with an RFS (TREAI-RFS and TREBI-RFS) with a high intensity eccentric resistance training without RFS (TREAI) in knee extensors. Method: The study will consist of 45 male participants, allocated from a stratified randomization into three groups: TREAI (n = 15), TREAI-RFS (n = 15) and TREBI-RFS (n = 15). Participants underwent a training program with a minimum of 40% without RFS, 80% with RFS and 40% with CVS of CVIM, 3 times a week, and the outcomes of muscle strength, muscle structure, power test and Endothelial growth will be assessed one week before, the fourth week and one week after the end of the training program. In addition, clinical markers of perception and recovery effort are investigated before and after a session. The graph used is descriptive and descriptive, as it is used as a model of analysis of variance for the analysis of replications without a two-factor scheme, which provides detailed information on how the measures are repeated, neither. A whole statistical analysis can reach the level of significance of 5%.


Eligibility Criteria:
Inclusion Criteria:

* male sex;
* healthy;
* aged between 18 and 35 years

Exclusion Criteria:

* smokers;
* alcoholics;
* use drugs that influenced cardiac autonomic activity;
* cardiovascular, metabolic or endocrine diseases.
Preventing Catheter-Associated Urinary Tract Infections With a Virtual Simulation Game

Objective: The purpose of this study was to investigate the effectiveness of a virtual simulation game in improving nursing students' knowledge and abilities in preventing catheter-associated urinary tract infection (CAUTI).

Method: The study was designed as a parallel-group, randomized controlled trial. A pre-test on knowledge and abilities will be administered to all students participating in the study. Following the pre-test evaluation, a training session on "CAUTI Prevention" will be held. The present training approach (lecture method) in the curriculum will be employed in this session. Following the training, the students in the sample group will be randomly divided into the experimental group (students using virtual simulation game application) and the control group (students learning with the existing education method) based on their general weighted grade averages using the stratified randomized approach. The experimental group will play the virtual simulation game for seven days. Knowledge and competence assessments (post-test) of the control and experimental groups will be conducted seven days following the training. The virtual simulation game application will be evaluated by the students in the experimental group after the post-test evaluations. The students' positive, negative, and constructive feedback on the virtual simulation game will be solicited during the assessment. In addition, these students will score in a 5-point Likert type to evaluate the statements about the virtual simulation game.

Hypothesis: H0-1: There is no difference in knowledge about preventing CAUTI between students using the virtual simulation game method and students in the control group.

H1-1: There is a difference in knowledge about preventing CAUTI between students using the virtual simulation game method and students in the control group.

H0-2: There is no difference in CAUTI prevention skills between students using the virtual simulation game method and students in the control group.

H1-2: There is a difference in CAUTI prevention skills between students using the virtual simulation game method and students in the control group.


Eligibility Criteria:
Inclusion Criteria:

* To be enrolled in Nursing Profession Courses Practice-II for the first time
* To agree to participate in the study
* To have internet access and smartphone or computer

Exclusion Criteria:

* Not filling in the data collection forms of the research at any stage
* Answering the data collection forms of the research incomplete
* Not having received the first or last skill assessments
* Not attending the training on preventing CAUTI
* Not playing/completing the virtual simulation game
Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification in Arresting Early Childhood Caries

Arresting dental caries using silver diamine fluoride (SDF) has gained attention recently for the management of early childhood caries (ECC). However, black staining is one of its drawbacks. A possible affordable alternative can be Sodium Fluoride (NaF) supported with good oral hygiene induced by parental Motivational Interviewing (MI).

The trial aims to compare the impact of SDF versus NaF supported by MI on lesion activity in preschool children.


Eligibility Criteria:
Inclusion Criteria:

1. Children aged ≤ 4 years old.
2. The presence of at least one active carious lesion on a primary tooth, with scores 3 and higher (according to the International Detection and Assessment System- ICDAS II)
3. Children whose caregivers have means of communication (mobile phones).
4. Completion of an informed consent to participate in the study.

Exclusion Criteria:

1. Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling and/or abscess.
2. Parental refusal to participate in the study.
3. Allergy or sensitivity to silver or any of the materials included in the study.
The Effect of Music Therapy on Vital Signs and Heart Rate Variability of Pediatric Patients During the Extubation Process.

The extubation process is critical to the future health outcomes of the pediatric patient because it tests the ability of the respiratory system to function without the support of mechanical ventilation. However, extubation can cause stress, pain, anxiety, or discomfort in the patients, which results in an increased likelihood of reintubation. Music therapy has been shown to be effective in reducing anxiety and stress levels in ventilated adult patients, but studies evaluating the effect of music therapy on vital signs in pediatric patients during extubation are lacking.

The aim is to determine the effect of music therapy on vital signs and heart rate variability of pediatric patients during extubation in in two high-complexity health care institutions in Colombia.

This study is a Randomized clinical trial (RCT) with two parallel arms. The intervention group (IG) will receive standard care during the extubation process + music therapy and the control group (CG) will receive standard care only. The primary outcome measure is heart rate (HR) measured every minute for 5 minutes before extubation, during extubation, and up to 10 minutes after extubation. Secondary measures are: oxygen saturation, respiratory rate, blood pressure, duration of the procedure, number of reintubations, and heart rate variability.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients hospitalized who are undergoing an extubation process.

Exclusion Criteria:

* Pediatric patients with accidental extubation or deterioration of the respiratory pattern after extubation that precludes monitoring for 10 minutes post-extubation will be excluded.
Clinical and Ultrasound Incidence of Rheumatologic Immune Related Adverse Events in Stage IIB-IV Melanoma Patients

Rheumatologic adverse events are expected to affect between 3% and 7.5% of patients undergoing immunotherapy and are likely to be underdiagnosed.

The main aim of this observational prospective study is to investigate the clinical and ultrasonographic incidence of rheumathologic immune related adverse events in a cohort of patients affected by stage IIB, IIC, III and IV melanoma undergoing treatment with immune-checkpoint inhibitors.

Patients will:

* receive immune-checkpoint inhibitor therapy, according to disease stage and current National Guidelines.
* undergo dermatologic visit prior to the start of immune-checkpoint inhibitor therapy and at scheduled follow-ups.
* undergo rheumatologic visit prior to the start of immune-checkpoint inhibitor therapy and at scheduled follow-ups.
* receive a quality of life questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0) prior to the start of immune-checkpoint inhibitor therapy and at scheduled follow-ups.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients affected by stage IIB, IIC, III and IV melanoma who start systemic therapy with immune-checkpoint inhibitors.
* Signature of the patient consent to the study.

Exclusion Criteria:

* Patients aged below 18 years of age.
* Patients who are unable to express consent to the study.
* Patients with a diagnosis of chronic joint diseases: inflammatory arthritis, arthrosis, microcrystalline arthritis, septic arthritis etc.
* Systemic diseases with likely joint involvement (inflammatory bowel disease, etc.)
* Previous treatments with immune-checkpoint inhibitors or previous adjuvant therapy with immune-checkpoint inhibitors.