cyrilzakka/clinical-trials huggingface dataset:
Selecting the Right Hip Prosthesis for Young Patients

There have been no previously published clinical randomized studies comparing Primoris®, short stem, hip prosthesis with standard uncemented hip arthroplasty in relation to bone density and function development. This is the subject for this study.

The overall purpose of this study is to show whether the Primoris® hip prosthesis results in a smaller loss of bone density than standard hip prosthesis, which in the longer term may result in an improved survival of prosthesis No. 2 after revision / replacement of a Primoris® hip prosthesis.

The primary outcome is periprosthetic bone quality in Primoris® hip prosthesis compared to standard hip prosthesis measured by DXA scanning.

The secondary outcomes are to assess:

1. The hip function measured by gait analysis.
2. Hip strength at pressure gauge.
3. Prosthetic migration / migration measured by radio-stereometric analysis (RSA).
4. Patient satisfaction measured by PROMs.

Eligibility Criteria:
Inclusion Criteria:

Women ≤ 45 years or men ≤ 55 years with hip osteoarthritis, suitable for hip prosthesis.

Patients who wish to participate in the project and give written consent after oral and written information.

Exclusion Criteria:

1. Patients with previous bone disease, metabolic disease, including diabetes, or the use of drugs that affect bone density.
2. Smoking more than 20 cigarettes daily
3. Patients with fracture in the femur or acetabulum.
4. Patients who do not understand the given patient information
5. Competing disorder requiring treatment with antiinflammatory drugs (NSAIDs, steroid, cytostatics).
6. Estimated residual life \<10 years
7. Rheumatoid arthritis or other arthritis (eg psoriasis arthritis).
8. Previous surgery on the relevant hip joint.
9. Co-Morbidity (ASA Group 3-5).
10. Neurological disorder that compromises motor skills and rehabilitation.
11. Pregnancy.
12. Osteoarthritis secondary to mb. Calvé-Legg-Perthes / Avascular Caput Necrosis, Epiphysiolysis Capitis Femoris and Multiple Epiphysic Dysplasia.
13. Acetabular dysplasia with secondary subluxation (Crowe grade II to IV).
14. Previously detected osteoporosis or osteoporosis detected by current DXA scanning.
15. Ongoing treatment with osteoporosis medicine (bisphosphonates, estrogen receptor modulators and parathyroid hormone, etc.).
16. Aseptic caput necrosis (posttraumatic, idiopathic).
17. Varus or valgus deformity in proximal femur (collum angle \<125 ° or\> 145 °.)
18. Collum femoris assessed too retro- or anteverted.
Effect of Simulator Practice on Trainees' Endoscopic Retrograde Cholangiopancreatography (ERCP) Performance in the Early Learning Period

In a RCT, mechanical simulator practice enhances clinical ERCP performance of novice trainees during the first 3 months of usual ERCP training.

Background: The impact of mechanical simulator practice on clinical ERCP performance has not been reported.

Hypothesis: Practice with mechanical simulator improves clinical ERCP performance of novice trainees.

Design: A prospective randomized controlled trial.

Method: 8 trainees without prior ERCP experience from 2 hospitals attended didactic lectures on ERCP. They were randomized in pairs (per hospital) to receive simulator practice and usual training (S) versus usual training only as control (C). Simulator practice included selective bile and pancreatic duct cannulation using a catheter and/or guide wire with different artificial papillae (flat, standard, dual channels) and settings (standard, rotated papilla or duodenum), and exchange of guide wire/accessories and biliary stenting. Local trainers tracked trainees' subsequent clinical ERCP performance for 3 months. Evaluation of trainee skills included success of diagnostic CBD and deep CBD cannulation. Trainer blinded to the randomization provided assessment (1=poor, 5=excellent) of each trainee performed ERCP.

Statistics: Fisher exact test and Mann-Whitney U test.

Eligibility Criteria:
Inclusion Criteria:

* GI trainees who met the minimum endoscopy training experience

Exclusion Criteria:

* GI trainees with no endoscopy experience
Surufatinib Combined With Toripalimab and Chemotherapy in the Treatment of Non-Small Cell Lung Cancer

A phase II study to assess the efficacy and safety of Surufatinib Combined With Toripalimab and Chemotherapy as a first-line treatment in patients with advanced non-squamous non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary provision of informed consent.
2. Males or females aged 18-75.
3. Histological or cytologically confirmed NSCLC, metastatic or non-resectable (stage IIIB-Ⅳ).
4. At least one lesion can be measured by imaging.
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
6. Life expectancy ≥ 12 weeks.
7. None previous chemotherapy or targeted therapy(Arm:wild-type genotype).
8. Patients should be confirmed acquired EGFR T790M mutation and received adequate EGFR-TKI treatment(Arm:EGFR mutation).
9. Female of childbearing age must have a negative pregnancy test (serum or urine) within 7 days before enrolment.

Exclusion Criteria:

1. Histological or cytologically confirmed small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC.
2. Diagnosed with other malignant diseases other than NSCLC within 5 years.
3. Have participated in other interventional clinical research treatments now or within 4 weeks.
4. Have previously received multi-targeted kinase inhibitors therapy.
5. Have active autoimmune diseases requiring systemic treatment within 2 years.
6. Received systemic glucocorticoid therapy or immunosuppressive therapy within 2 weeks.
7. Clinically uncontrollable pleural effusion/abdominal effusion.
8. Vaccinated vaccines or attenuated vaccines within 4 weeks before the group;
9. Pregnant or breastfeeding females.
10. Other serious hazards to the safety of patients.
VIVO European Observational Registry

A multi-center, observational registry conducted in Europe and the UK to prospectively review VIVO in a clinical setting in 125 patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients must at least 18 years of age Patients who have signed an IRB/EC approved patient informed consent and applicable patient privacy protection authorization per local law
* Patients who have previously had contrast cardiac imaging or will have cardiac imaging ordered per standard of care
* Patients will be selected without regard to gender.

Exclusion Criteria:

• Patients that are unable to receive contrast cardiac imaging (MR or CT)
Liposomal Daunorubicin in Treating Patients With HIV-Related Kaposi's Sarcoma

RATIONALE: Drugs used in chemotherapy, such as liposomal daunorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This clinical trial is studying how well liposomal daunorubicin works in treating patients with HIV-related Kaposi's sarcoma.

OBJECTIVES:

Primary

* Determine the effect of liposomal daunorubicin citrate on Kaposi's sarcoma-associated herpes virus (KSHV) viral gene expression in tumors of patients with HIV-related Kaposi's sarcoma.

Secondary

* Determine the effect of this drug on KSHV viral gene expression in peripheral blood mononuclear cells.
* Determine the effect of this drug on KSHV viral load in plasma.
* Correlate viral load with viral gene expression and/or tumor regression in these patients.

OUTLINE: This is a multicenter, pilot study.

Patients receive liposomal daunorubicin citrate IV days 1 and 15. Treatment repeats every 4 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity.

Biopsies are performed at baseline and once during treatment to evaluate Kaposi's sarcoma- associated herpes virus (KSHV) viral gene expression in tumors and skin tissue using reverse transcriptase-quantitative polymerase chain reaction. Blood samples are collected at baseline and periodically during treatment to evaluate KSHV viral gene expression in peripheral blood mononuclear cells and viral load in plasma.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed Kaposi's sarcoma (KS) involving the following:

  * Skin
  * Lymph nodes (palpable disease only)
  * Oral cavity
* Must have ≥ 5 measurable, previously nonirradiated, cutaneous lesions that can be used as indicator lesions
* Must have 2 lesions ≥ 5 x 5 mm that are accessible for 4 mm punch biopsy
* Serologically confirmed HIV positivity
* Concurrent antiretroviral therapy required, except for patients who have exhausted all available treatment options

  * Must be on a stable dose for ≥ 4 weeks

PATIENT CHARACTERISTICS:

* Life expectancy ≥ 3 months
* No other neoplasia requiring cytotoxic therapy
* Not pregnant or nursing
* Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior anthracycline therapy
* At least 4 weeks since prior antineoplastic treatment for KS, including any of the following:

  * Chemotherapy (6 weeks for nitrosoureas or mitomycin C)
  * Radiotherapy
  * Local therapy
  * Biological therapy
  * Investigational therapy
* At least 60 days since prior local therapy of any KS indicator lesion unless lesion has clearly progressed since treatment
* No other concurrent investigational drugs, cytotoxic chemotherapy, or KS-specific treatment
A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma

This is a Phase 1, multicenter, open-label study of CC-98633, BCMA-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in participants with relapsed and/or refractory multiple myeloma.

The study will consist of 2 parts: dose-escalation (Part A) and dose-expansion (Part B). The dose-escalation part (Part A) of the study is to evaluate the safety and tolerability of increasing dose levels of CC-98633 to establish a recommended Phase 2 dose RP2D(s); and the dose-expansion part (Part B) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of CC-98633 at the RP2D(s).


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Signed written informed consent prior to any study procedure.
3. Relapsed and/or refractory multiple myeloma (MM).

   1. Subjects must have documented progressive disease as per International Myeloma Working Group (IMWG) criteria during or within 12 months of completing treatment with the last anti-myeloma treatment regimen before study entry. Also, subjects with confirmed progressive disease within 6 months prior to start of Screening and who are refractory (or non-responsive) to their most recent anti-myeloma treatment regimen afterwards will be also eligible.
   2. Part A and Part B Cohort A: Subjects must have confirmed at least 3 prior antimyeloma treatment regimens.
   3. Part B Cohort B only: Subjects must have received at least 1 but no greater than 3 prior antimyeloma treatment regimens, including a proteasome inhibitor and immunomodulatory agent.
   4. Subjects must have previously received all of the following therapies:

   i) Autologous stem cell transplant ii) A regimen that included an immunomodulatory agent (eg, thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib), either alone or combination iii) Anti-CD38 (eg, daratumumab), either alone or combination Subjects in Cohort B do not require prior anti-CD38 antibody therapy.
4. Measurable disease
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Adequate organ function

Exclusion Criteria:

1. Known active or history of central nervous system (CNS) involvement of MM
2. Active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis
3. Prior treatment with CAR T-cell or another genetically modified T-cell therapy
4. Part A and Part B Cohort A only: Prior treatment with investigational therapy directed at BCMA
5. Uncontrolled or active infection
6. Active autoimmune disease requiring immunosuppressive therapy
7. History or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
Cardiac Output Monitoring in Critically Ill Patient Undergoing Intubation

Collect hemodynamic data, such as heart rate, blood pressure, and cardiac output to help understand the effect of pre and post intubation.

A Non-invasive physiologic monitor, Non-Invasive Cardiac Output Monitor (NICOM), will be utilized for this study. This is the first completely non-invasive hemodynamic device approved by the FDA and available for clinical use produced by Cheetah Medical and utilizes Bioreactance (Tel Aviv, Israel). It performs accurately and with precision in all patient's studied and requires only 4 adhesive gel pads on the skin to measure continuous cardiac output and to calculate Stroke Volume Variation (SVV). Other physiologic data (blood pressure, total peripheral resistance (TPR), stroke volume (SV), and heart rate) will be analyzed in real time and recorded on the device and downloaded into an excel database. The data on the device will be downloaded weekly onto the excel database and deleted on the device. The Study personnel will be trained in its use prior to study initiation.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring endotracheal intubation in the intensive care unit.

Exclusion Criteria:

* Patients previously enrolled in this study.
* Patients requiring intubation outside of the intensive care unit.
Expanded Access Program for Epcoritamab

The purpose of this program is to provide investigational epcoritamab, an antibody also known as GEN3013 (DuoBody-CD3xCD20), in an expanded access setting for eligible patients with relapsed and/or refractory (R/R) large B-cell lymphoma (LBCL) who have a high unmet medical need with no other treatment options. It is a requirement that patients do not qualify for an ongoing epcoritamab clinical program or are unable to participate due to logistical reasons.

Access to investigational epcoritamab can be requested by contacting preapprovalaccessprograms@genmab.com.

This is a multicenter program conducted within the United States. The program will consist of screening, treatment (Cycle 1 Day 1 until epcoritamab discontinuation), safety follow-up, post-treatment and/or survival follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age or older
* R/R CD20+ mature B-cell neoplasm
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, 1, or 2
* ≥ 2 prior lines of antineoplastic therapy, including ≥ 1 anti-CD20 monoclonal antibody (mAb)
* Fluorodeoxyglucose (FDG) positron emission tomography (PET)-avid and measurable disease by computed tomography/magnetic resonance imaging (CT/MRI)
* Patients considering the EAP should have no other available therapeutic option and cannot be eligible for other epcoritamab trials.
* Patients considering the EAP must be located in proximity to a US site given that the EAP is currently available only in the United States.
* Prior to initiating any program-related assessments or procedures, patients (or their legally acceptable representative) must sign an informed consent form (ICF), which indicates the purpose of the program, the procedures required for the program, and confirms the patient's willingness to participate in the program.

Exclusion Criteria:

* Any prior therapy with an investigational bispecific antibody targeting CD3 and CD20
* Prior treatment with CAR-T therapy within 100 days prior to first epcoritamab administration
* Primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma
* Confirmed history of or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy. Low-dose prednisolone for rheumatoid arthritis or similar conditions is allowed.
* Active hepatitis B or hepatitis C
* Known clinically significant cardiac disease
* Pregnancy or breastfeeding
* Known hypersensitivity to allopurinol or rasburicase
Prolonged Mechanical Ventilation in Neurosurgical Patients:

The study was carried out at the neurosurgical operating theater and neurosurgical intensive care unit, Maharaj Nakorn Chiang Mai University-Hospital. The study design was a retrospective Cohort study, recruited elective adult neurosurgical patients during December 1, 2021 to December 31, 2022. The patients were excluded if they had pre-operative definite airway control. The primary outcome was extubation success in the operating theater. Prolonged mechanical ventilation (PMV) means the patients who could not undergo the weaning protocol and extubation in 48 hours of surgery. The secondary outcome was the features associated with the prolonged mechanical ventilation.

Extubation in operating theater after elective intracranial surgery is superlative. Early extubation strategy should be planned in preoperative period jointly with neurosurgical team. Any deviations from the plan should be identified, whether they originated from surgical aspects or anesthetic managements. The time-point for extubation in neurosurgical patients is more challenging compared to other non-brain surgeries. We identified some potential prognostic impacts to prolonged mechanical ventilation in elective neurosurgical patients.

The study was approved by the Institution Research Ethics Committee Panel 5, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. (ANE-2565-09317). The study was carried out at the neurosurgical operating theater and neurosurgical intensive care unit, Maharaj Nakorn Chiang Mai University-Hospital. The study design was a retrospective Cohort study, recruited elective adult neurosurgical patients during December 1, 2021 to December 31, 2022. The patients were excluded if they had pre-operative definite airway control. The primary outcome was extubation success in the operating theater. Prolonged mechanical ventilation (PMV) means the patients who could not undergo the weaning protocol and extubation in 48 hours of surgery. The secondary outcome was the features associated with the prolonged mechanical ventilation. For continuous data, we used the student's t-test. For categorical data, we used the Fisher's exact or Chi-square test. Univariate analysis and multiple logistic regression were used to identified the prognostic factors. P values \&lt; 0.05 indicated statistical significance.

Eligibility Criteria:
Inclusion Criteria:

* adult neurosurgical patients
* undergo elective surgery

Exclusion Criteria:

* already intubation before neurosurgical procedures
* tracheostomy
Healthy Meals: A Restaurant-based Study to Promote Healthy and Allergy Adapted Diet

This study evaluates the effect of a multicomponent intervention applied to restaurant staff about training and nutritional quality of menu improvement, in order to promote a healthy diet and a better management of allergies and intolerances addressed to each family member satisfying the customers with specific needs (allergies and intolerances of food).

The aim is to test the effect of a multicomponent intervention applied to restaurant staff about training and nutritional quality of menu improvement, in order to promote a healthy diet and a better management of allergies and intolerances addressed to each family member satisfying the customers with specific needs (allergies and intolerances of food).

The study is a 12-month restaurant-based intervention study, randomized, controlled and parallel.

Eligibility Criteria:
The inclusion and exclusion criteria were about restaurants, as a unit of randomization. This study is randomized.

Inclusion Criteria:

* to have signed informed consent by the restaurant owner,
* to have minimum 5 tables of service,
* to offer local or Mediterranean food and recipes on the menu,
* to have the recipes with ingredient and cooking steps details, and
* to share the food products information used in the restaurant with the research team.

Exclusion Criteria:

* To be an ethnic restaurant, fast-food restaurant or a restaurant with a single product like only pizza, sushi, etc
* Lack of one of the inclusion criteria
Treatment With Duloxetine for OCD Patients

Testing the efficacy of the SNRI medication Duloxetine for treating OCD patients who did not respond to SSRI


Eligibility Criteria:
Inclusion Criteria:

* OCD as main diagnosis according to DSM-IV
* Age 18 to 65
* Men and women
* YBOCS score is 18 or more, or 12 or more in case of only obsessions

Exclusion Criteria:

* Patients treated with Duloxetine, currently or in the past
* Patients having comorbid schizophrenia or psychotic disorder or bipolar disorder Patients with substance abuse disorder in the last 6 months Patients who were suicidal or did serious suicide attempt in the last year Pregnant or lactating women, or woman of childbearing potential, which is not using adequate contraception Patients with neurologic disturbance or disorder Patients with serious or imbalanced medical condition Patients with allergic response to SSRI or duloxetine Patients who started new treatment (CBT or pharmacology) in less than 3 months
Selenium in Treating Patients With Prostate Cancer

RATIONALE: Selenium may prevent or slow the growth of prostate cancer.

PURPOSE: This randomized phase II trial is studying how well selenium works in treating patients with prostate cancer.

OBJECTIVES:

* To investigate the ability of selenium to prevent progression in patients with adenocarcinoma of the prostate.
* To investigate the ability of selenium to effectively modulate biomarkers of prostate cancer.
* To determine if selenium modifies the progression of prostate cancer based on an analysis of initial biopsy, subsequent blood biomarkers, and urological symptoms.
* To further establish the safety of chronic supplementation with selenium in these patients.

OUTLINE: Patients are stratified according to Gleason score (low vs moderate). Patients are randomized to 1 of 3 treatment arms.

* Arm I: Patients receive oral placebo once daily for 48 months in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive low-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity.
* Arm III: Patients receive high-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity.

Blood and tissue samples are collected periodically for biomarker laboratory studies. Blood samples are analyzed for levels of prostate-specific antigen, chromogranin A, alkaline phosphatase, alpha tocopherol, lycopene, and other vitamins; levels of selenium by atomic absorption spectrometry; and oxidative damage to DNA. Tissue samples are analyzed for levels of Bcl-2, p53, Ki-67, thioredoxin reductase, thioredoxin, and glutathione peroxidase by immunohistochemistry and for apoptotic index by TUNEL assay.

Patients complete urological symptom questionnaires and other questionnaires periodically.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Biopsy-proven adenocarcinoma of the prostate within the past 48 months
* Prostate-specific antigen \< 50 ng/mL
* Gleason score \< 8
* Currently undergoing "watchful waiting" for prostate cancer
* No metastatic disease

PATIENT CHARACTERISTICS:

* Life expectancy ≥ 3 years
* AST and ALT ≤ 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 1.5 times ULN
* Bilirubin ≤ 1.5 times ULN
* Creatinine ≤ 1.5 times ULN
* No other malignancy within the past 5 years, except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

* No prior hormone therapy, radiotherapy, chemotherapy, or surgery for prostate cancer
* At least 90 days since prior and no concurrent selenium (as a dietary supplement or as part of a multivitamin) exceeding 50 mcg/day