cyrilzakka/clinical-trials huggingface dataset:
Prospective Evaluation of Interventional Studies on Bone Metastases - the PRESENT Cohort

Bone metastases are frequent distant manifestations of cancer, with pain as a common and devastating consequence. The primary treatment for painful bone metastases, external beam radiation therapy, is moderately effective: about 60% of patients who undergo conventional radiotherapy experience (partial) pain relief. Several factors associated with treatment failure have been identified, but no attempts have been made to collapse these factors into a clinically useful prediction tool to predict treatment response. In addition, to aid in therapy selection based on expected survival time, development of survival models is essential. Finally, we need innovative treatments as alternatives or additive to standard treatment options to improve quality of life (QoL). For these reasons, we set up the PRESENT cohort study, recruiting patients at the departments of radiation oncology and orthopedic surgery.

We aim to provide detailed information about clinical data, create an infrastructure for efficient, fast and pragmatic evaluation and implementation of innovative interventions, as well as development of accurate new prediction tools.

The PRESENT cohort is set up according to the 'cohort multiple Randomised Controlled Trial' design. The basis of this design is a prospective cohort of patients with bone metastases, receiving care as usual, who give informed consent for cohort participation. At the UMC Utrecht, patients are furthermore asked for informed consent to be randomized in future RCTs conducted within the cohort. Patients are informed that they will be offered the experimental intervention if they are randomly selected. They are also informed that they otherwise might serve as controls without being notified and that their data can be used in a trial context. For each patient in the cohort, clinical and patient-reported outcomes are captured at baseline and at regular intervals during follow-up. Within this cohort, multiple RCTs can be conducted. For this purpose, eligible patients who have provided the consent required for them to participate in an RCT within the cohort are identified. From this subcohort, a random selection of patients will be invited to undergo the experimental intervention. Eligible participants who were not randomly selected receive standard care, are not informed about the experimental intervention and serve as controls. Outcomes in this control group are compared with the outcomes of those who were offered the experimental intervention, in order to estimate the effect of the experimental intervention versus usual care. Within the cohort, the same process can be repeated for trials of other interventions.

Eligibility Criteria:
Inclusion Criteria:

* Histologic proof of malignancy;
* Radiographic or histologic proof of metastatic bone disease;
* Undergoing radiotherapy;
* Age \> 18 years;
* Informed consent - at least - for use of routinely collected clinical data.

Exclusion Criteria:

* Mentally incompetent patients;
* Life expectancy \< 1 week indicated by the treating physician.
Predictors of Failure of Non-invasive Ventilation and High Flow Nasal Cannula

Comparison between some predictors of failure of non-invasive ventilation and high flow nasal cannula.

Delayed intubation after NIV / HFNC failure is associated with high mortality rate in acute respiratory failure patients.

There are Many factors to predict early failure but World still searching for new factors and comparing between each ;in order to eatablish best one that achieve the least mortality rate.

Little studies about effiecacy of HACOR Score as a predictor of failure in HFNC patients.

Little studies about effiecacy of ROX Index as a predictor of failure in NIV ventilating patients.

Eligibility Criteria:
Inclusion Criteria:

Acute respiratory failure patients who need ventilatory Support either NIV or HFNC due to :

1. RR \> 25 cycle / min
2. using accessory muscles and paradoxical breath.
3. PaO2 / FiO2 ratio \< 300

Exclusion Criteria:

1. Absolute indication for intubation like coma, haemodynamically unstable... etc
2. Contr-indication of NIV like untreated Pneumothorax.
Effect of Adductor-Canal-Blockade on High Pain Responders After Total Knee Arthroplasty

The purpose of this study is to determine whether Adductor-Canal-Blockade (ACB) is superior to placebo when it comes to analgetic efficacy in high pain responders after Total Knee Arthroplasty (TKA). High pain responders are defined as patients reporting VAS \> 60 during knee flexion the 1. or 2. day after surgery.

The patients will be included the 1. or 2. day after surgery. All TKA patients will be screened. Those reporting VAS \> 60 during active 45 degrees knee flexion will be asked to participate.

Included patients will receive 2xACB (singleshot) first placebo (30ml saline) and then ropivacaine (30ml ropivacaine 7,5mg/ml) or the other way around (randomized). There will be 45 minutes between the two blockades. The blockades will be ultrasound guided.

Eligibility Criteria:
Inclusion Criteria:

* TKA within 48 hours and VAS\>60 during active 45 degrees knee flexion despite conventional pain medication.
* Informed consent
* ASA 1-3
* BMI 18-40

Exclusion Criteria:

* Unable to communicate in Danish
* Allergic reactions toward drugs used in the
* Abuse of alcohol/drugs
* Unable to cooperate
Radiological and Biological Tumoural and Peri-tumoural Factors in Neoadjuvant Endocrine-treated Breast Cancers

The purpose of this study is to monitor the change in cancer size in women with breast cancer on anti-hormone treatment using different types of assessment including ultrasound scan (US), shearwave elastography (SWE) and magnetic resonance imaging (MRI), and assess how this corresponds to the changes in the cancer biology.

Background Endocrine resistance is a significant problem in the management of breast cancer, with increasing evidence that the tumour microenvironment is influential on tumour growth and disease resistance. The neoadjuvant setting provides an excellent opportunity to observe tumour response to treatment in vivo, allowing development of methods for monitoring and predicting response to treatment.

Aims To assess potential radiological and biological tumoural and peri-tumoural biomarkers in patients before and during neoadjuvant endocrine treatment. Our hypothesis is that there will be less response in women with abnormal peri-tumoural stroma, and that tumours with high monocarboxyl transporter (MCT4) and loss of caveolin-1 in stroma are resistant to endocrine treatment.

Techniques and Methodology Patients with primary breast cancer receiving neoadjuvant letrozole will undergo radiological assessment with digital mammogram, US including SWE, and MRI. Core biopsies will be taken at diagnosis and at surgery from tumour and peri-tumoural stroma, and assessed for biomarkers lysyl oxidase (LOX), fibronectin, collagen, proliferation, MCT4 and caveolin-1. All data will be correlated to peri-tumoural abnormalities on MRI and SWE.

Impact on breast cancer research This study will provide information on the ability of SWE and MRI to predict and detect endocrine resistance, correlated with biological markers that are associated with endocrine resistance. Identifying resistant tumours can prevent unnecessary treatment and reduce risks of recurrence as alternative or additional therapies can be utilised.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women: Defined as \>12 months amenorrhoea in absence of medical therapy known to induce this; or bilateral oophorectomy; or if last menses \<12 months before starting treatment, FSH \>35 IU/L and LH \>40 IU/L.
* ER positive (Allred score \>3) invasive breast cancer
* Staging as T1-4, N0-2, M0
* Patient agreed to neoadjuvant endocrine therapy as recommended by MDT
* Fresh tissue stored at time of diagnostic core biopsy
* Suitable for, and tolerant of MRI scan
* Fit for surgical intervention at time of entry into study

Exclusion Criteria:

* Premenopausal or unable to determine menopausal status
* Not fit for surgical intervention due to co-morbidities
* Contraindication for MRI (including severe claustrophobia)
* Current use of HRT, or HRT use at time of diagnostic core biopsy
Effect of Some Drugs on Rheumatoid Arithritis Activity

Effect of Some Drugs on Rheumatoid Arithritis Activity.

The study aims at evaluating the effect of Some Drugs on Rheumatoid Arithritis Activity.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis

Exclusion Criteria:

* liver or renal disease
Correction of Multiplanar Deformities Around the Knee With Monolateral External Fixator

Angular deformities around the knee are one of the common cause of presentation at pediatric orthopedic clinic. Although these conditions are commonly benign and self-limiting.

The mechanical axis of the lower extremity is a straight line extending from the center of the femoral head to the center of the ankle. The horizontal distance in millimeters from the center of the knee joint to the mechanical axis is the deviation of the mechanical axis.

The goal of treatment is to correct malalignment of the lower extremity and perhaps to prevent or delay the onset of osteoarthritis by normalizing the mechanical axis


Eligibility Criteria:
Inclusion Criteria:

* Genu valgus having tibio-femoral angle more than 15 degrees.
* Genu varus having metaphyseal-diaphyseal angle of more than 11 degrees
* More than one plane defirmity
* Age 10 - 16 yrs
* Range of motion:

  1. Full extension
  2. More than 100 in flextion

Exclusion Criteria:

* Genu recurvatum.
* Flexion deformity.
* Pathological conditions (e.g: bone softening diseases
* Dysplasia
* Limb length discrepancy
A Study of Islatravir (MK-8591) in Anti-Retroviral Therapy-Naive, Human Immunodeficiency Virus-1 Infected Participants (MK-8591-003)

This study will evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral therapy (ART) activity of islatravir (MK-8591) monotherapy in ART-naive, human immunodeficiency virus-1 (HIV-1) infected participants. The primary hypothesis is that at a safe and tolerable dose of islatravir, the true mean difference in the plasma HIV-1 ribonucleic acid (RNA) reduction from baseline between islatravir and placebo is at least 0.5 log (base10) copies/mL.


Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant, non-breast feeding, postmenopausal or surgically sterile female
* Female with reproductive potential agrees to use (or have male partner use) two acceptable methods of birth control
* Male agrees to use acceptable method of contraception during study and for 90 days after last dose of trial drug
* Has stable baseline health, other than HIV infection
* Has no significantly abnormal electrocardiogram
* Is HIV-1 positive
* Have a screening plasma HIV-1 RNA ≥ 10,000 copies/mL within 30 days prior to the treatment phase of this study. For inclusion in Panel Islatravir Extended Observation, participants must also have a screening plasma HIV-1 RNA ≤ 25,000 copies/mL within 30 days prior to the treatment phase.
* Is ART naive
* Has not received any investigational agent or marketed ART within 30 days of trial drug administration
* Is diagnosed with HIV-1 infection \>= 3 months prior to screening
* Is willing to receive no other ART during treatment phase of study
* Has no evidence of mutations conferring resistance to nucleoside reverse transcriptase inhibitors (NRTIs)

Exclusion Criteria:

* Is mentally or legally institutionalized/incapacitated, or has significant emotional problems, or has a history of clinically significant psychiatric disorder of the last 5 years
* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological (outside of HIV-1 infection), renal, respiratory, genitourinary, major neurological abnormalities or diseases
* Has a history of cancer (malignancy)
* Has a history of significant multiple and/or severe allergies, or had an anaphylactic reaction to drugs or food
* Is positive for hepatitis B surface antigen
* Has a history of chronic Hepatitis C
* Had major surgery or lost 500 mL of blood with 4 weeks prior to screening visit
* Has participated in another investigational trial within 4 weeks prior to dosing visit
* Will use any medications, prescribed drugs, or herbal remedies 4 weeks prior to dosing of trial drug, up to the post-trial visit
* Consumes excessive amounts of alcohol, caffeinated beverages, or tobacco products
* Uses illicit drugs or has a history of drug abuse within the prior 2 years
The Effects of Stress Reduction on Surgical Wound Healing

The purpose of this study is to investigate whether a stress reduction intervention prior to surgery can improve wound healing and recovery.The investigators hypothesise that patients who receive a psychological stress reduction intervention prior to surgery will report lower stress and higher perceived control, have lower stress hormones, better wound healing and better self-reported recovery than patients who receive standard care alone.

In previous prospective research, psychological stress has been shown to slow the healing of small superficial wounds and impair surgical healing. We will investigate whether a psychological intervention to reduce stress can improve surgical healing.

Ninety patients undergoing elective laparoscopic cholecystectomy will be randomised to receive either standard care or a brief pre-surgical psychological intervention plus standard care. Patients will complete a pre-surgical questionnaire to assess stress, anxiety, depression, illness perceptions and current health, at least 3 days prior to surgery. Then the intervention will be delivered. A second questionnaire on the morning of surgery will reassess stress, anxiety and illness perceptions to see whether the intervention has reduced stress and increased control perceptions. Plasma catecholamines and salivary cortisol will be tested to assess the effectiveness of the intervention in reducing stress-related hormones and to investigate their role in wound healing. During surgery 2 small expanded polytetrafluroethylene tubes will be inserted in the wound, which will be removed after 7 days. Wound healing will be assessed by hydroxyproline and total protein deposition in the tubes, as well as by the presence of wound infection. Patients' post-surgical recovery, including pain and fatigue, will also be assessed. If this brief psychological intervention can improve wound healing and aid recovery, it would provide a simple strategy to improve outcomes in surgery.

Eligibility Criteria:
Inclusion Criteria:

* planned elective laparoscopic cholecystectomy at Manukau Surgical Centre
* able to understand English
Malnutrition Clinical Characteristics Validation and Staffing Optimization Study (MCC Study)

The purpose of this study is to establish the validity of the adult and pediatric Malnutrition Clinical Characteristics (MCC). In addition, this project will: examine the relationship between the MCC and an objective measure of body composition; and establish the relationship between in-patient Registered Dietitian Nutritionist (RDN) care and medical outcomes for all in-patients requiring nutrition care, and specifically for malnourished patients. Sixty pediatric and 60 adult in-patient acute care facilities will participate in this research study. The total number of participants enrolled across the 120 facilities will be between 2400-9600.

The aims of the study include:

1. Assess the interrater reliability of the MCC.
2. Determine the predictive validity of the adult and pediatric MCC relative to a portfolio of patient medical outcomes.
3. Determine the relationship between the adult and pediatric MCC and body composition measurements conducted via bioelectrical impedance analysis (BIA) in a subset of patients.
4. Identify the utility of BIA for body composition analysis in clinical settings.
5. Estimate the level of RDN care necessary to improve patient outcomes within the portfolio of outcomes. Specifically: quantify the dose (minutes of care and frequency of encounters) of RDN care that is associated with improved medical outcomes in patients already identified as requiring nutrition care, after adjusting for disease severity and other potential confounders.
6. Identify the additional level of RDN care necessary to improve the medical outcomes in patients who have been identified as malnourished using the MCC.


Eligibility Criteria:
Inclusion Criteria:

* Adult and pediatric acute care patients at participating facility
* Newly identified as needing in-patient nutrition care through current facility policy
* Receive initial nutrition care one day before study enrollment day
* Patient is over one month of age, including infants, children, teenagers and adult patients who are intubated and/or sedated
* Patient, parent, legal guardian or legally authorized representative provide informed consent; children 7 and older provide assent
* Patient and/or parent, legal guardian or legally authorized representative are fluent in English or Spanish

Exclusion Criteria:

* Received nutrition care previously during current admission
* Pregnant women
* Prisoners
* Infants currently in the neonatal intensive care unit (NICU) with a diagnosis of prematurity
* Neonates of uncertain viability or non-viable neonates
* Patients receiving palliative/hospice care
* Patient admitted for long-term acute care (LTAC)
CARbon Impact of aNesthesic Gas

Assessing the impact of anesthesia practice on global warming and carbon footprint becomes part of the standard of care and is growing concern within the anesthesia community. Global Warming Potential (GWP) is a measure of how much a given mass of greenhouse gas contributes to global warming over a specified time period. Inhaled anesthetics have various GWP20: 349 for sevoflurane and 3714 for desflurane. However, GWP20 and CDE20 alone are not sufficient to evaluate the environmental impact of anesthetic gases. Other parameters must be included in the analysis: fresh gas flow (FGF), carrier gas (air, O2, N2O) and potency of the anesthetic gas. Unfortunately, the majority of trials did not fully consider the FGF reduction and the fact that desflurane can be administered with new closed or very low-flow anesthesia circuits as opposed as the recommended 2L/min that must be used for sevoflurane according to its monography in Canada. Most of the calculations were made on a purely theoretical approach that could be different from actual measurements based on a strictly monitored anesthesia practice. When continuous and accurate gas monitoring and analysis is used as recommended nowadays, the use of closed or semi-closed-circuit anesthesia with very low FGF might allow for a reduction of more than 80% of the anesthetic gas administration and its consequent pollution. By properly monitoring the anesthesia depth and analgesia adequacy, the investigators can reduce the gas consumption. The proposed study will aim at determining whether with the help of high-quality monitoring (BIS and NOL) and high-end ventilators that allow minimal fresh gas flow, the use of desflurane remains more polluting than sevoflurane.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1-3 patients,
* laparoscopic general, gynecological or urologic surgery requiring general anesthesia without additional regional anesthesia technique
* fully consented,
* BMI \< 40,
* age \> 18yo,

Exclusion Criteria:

* post-operative need for a neuraxial or regional analgesic technique
* history of active coronary artery disease
* serious cardiac arrhythmia (including atrial fibrillation)
* history of substance abuse
* chronic use of psychotropic and/or opioid drugs
* history of psychiatric diseases with the need of medication
* history of refractory PONV
* allergy or contra-indication to any drug used in the study protocol
* refusal of the patient for participation in the study
The Effectiveness of a High-Protein Liquid Dietary Supplementation

This study was a double-blind randomized controlled trial conducted to assess the effectiveness of high protein liquid dietary supplementation in malnourished hospitalized patients. The patients were assessed for their nutritional status based on ESPEN 2015 criteria. Patients who experienced malnutrition will be divided into 2 groups, namely the control group which was given a normal protein liquid diet, while the intervention group was given high protein liquid diet supplementation as much as 2 bottles (200 mL) per day for 7-10 days. Furthermore, the nutritional status of the patient was assessed.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged ≥ 18 years old to 60 years old
2. Malnutrition hospitalized patient based on European Society for Clinical Nutrition and Metabolism (ESPEN) 2015 criteria
3. Agreed to participate

Exclusion Criteria:

1. Malignancy
2. Chronic kidney disease stage III-V
3. Decompensated hepatic cirrhosis
4. Allergic to milk or lactose intolerance
5. Could not be randomised and participate in this study by clinical judgement
Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. in Rheumatoid Arthritis Patients

A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. \& Celebrex Cap. for Comparative Evaluation of Safety \& Efficacy in Rheumatoid Arthritis Patients


Eligibility Criteria:
Inclusion Criteria:

1. Adult males/Females aged 18\~80 years
2. Patient who are taking NSAIDs for the treatment of rheumatoid arthritis
3. Patients who belong to ACR functional class 1, 2, 3

Exclusion Criteria:

1. Patients who belong to ACR functional class 4
2. Patients who are hypersensitive to clinical trial medicines or excipient
3. Patients who have experience of Cerebrovascular bleeding, bleeding disorder
Comparisons of Complications Related to Two Approaches of Ultrasonography-guided Subclavian Venous Catheterization

For performing subclavian venous catheterization, two approaches (supraclavicular and infraclavicular) have been used successfully in various clinical practice. However, there remains controversy concerning which approach is safer and causes less complications during ultrasonography-guided subclavian venous catheterization. In this context, the investigators sought to compare supraclavicular approach with infraclavicular approach in terms of post-procedural complications during ultrasonography-guided subclavian venous catheterization.


Eligibility Criteria:
Inclusion Criteria:

* patients who require subclavian venous catheterization
* adult patients aged 20-79

Exclusion Criteria:

* patient's refusal
* patients with contraindication of subclavian venous catheterization (skin infection at puncture site, tumor or thrombus in the course of subclavian vein, vegetation at tricuspid valve, patients on anticoagulation)
* patients with chemoport or pacemaker in subclavian vein
* patients with right-sided breast cancer operation or with right-sided pneumonectomy