cyrilzakka/clinical-trials huggingface dataset:
SHR-A1811 Combined With Bevacizumab in HER2-positive Breast Cancer With Brain Metastases

This study aimed to evaluate the use of SHR-A1811 and bevacizumab in HER2-positive Breast Cancer with brain metastases


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old;
2. Pathologically confirmed HER2-positive breast cancer;
3. At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;
4. More than 2 weeks from last systemic treatment; patients with new brain lesions after craniocerebral surgery were admitted if no radiotherapy was performed.
5. Prior HER2-target treatment, endocrine therapy and chemotherapy was allowed;
6. Adequate function of major organs-

Exclusion Criteria:

1. Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor;
2. Previous treatment with bevacizumab;
3. Participated in other drug clinical trials within 4 weeks before admission;
4. History of clinically significant lung disease；
5. Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.
6. According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.).
7. Any other conditions that researchers believe that patients are unsuitable for this study.

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Peri-implant Soft Tissue Conditioning of Immediate Posterior Implants by CAD/CAM Socket Sealing Abutments

One of the major challenges one clinician can face while performing immediate placement on posterior area, is the ability of obtaining a hermetic primary closure of the soft tissue. The use of socket sealing abutment may provide advantages in maintaining the existing soft tissue architecture, preserving crestal bone height and reducing the risk of premature loading of the immediate implant during healing

One of the major challenges one clinician can face while performing immediate placement on posterior area, is the ability of obtaining a hermetic primary closure of the soft tissue. This technical skill is nearly always combined with invasive surgical procedures and significant post op recovery (displacement of the muco-gingival line, periosteal releasing incision, flaps, sutures, membrane stabilization, ...).the use of customized healing abutment may provide advantages in maintaining the existing soft tissue architecture, preserving crestal bone height and reducing the risk of premature loading of the immediate implant during healing.

Moreover, customized healing abutment can passively accommodate the definitive prosthesis with minimal or no pressure placement preventing biological or mechanical trauma during the prosthetic phases. This may lead to better long-term tissue stability and avoid the pain perceived by the patients from compression of tissues in case of standard healing abutment.

the primary aim of this randomized controlled clinical study is to clinically evaluate and compare the soft tissue outcomes of final immediate implant restorations placed in maxillary posterior sites that were conditioned by CAD/CAM fabricated socket sealing abutments versus standard healing abutments.

The secondary aim of this study is to radiographically assess peri-implant bone level changes of the final immediate implant restorations placed in maxillary posterior sites for the two experimental groups.

Eligibility Criteria:
Inclusion Criteria:

* 1. The patients ≥18 years old. 2. Non-restorable maxillary posterior teeth with intact adjacent teeth. 3. Sufficient bone to insert a dental implant with a minimum length of 8 mm and at least 3.5 mm in diameter.

  4. Type1 extraction socket according to Elian et al, 200742 (Labial bone plate and associated soft tissues are completely intact).

  5. Sufficient mesio-distal, bucco-lingual, and inter-occlusal space for placement of the definite restoration.

  6. Adequate oral hygiene (full mouth plaque score \< 25% and full mouth bleeding score \< 25%).

  7. Patients capable of understanding and giving informed consent.

Exclusion Criteria:

* 1. Alcohol or drug abusers. 2. Heavy smokers (\> 10 cigarettes/day). 3. Presence of acute periapical infections. 4. Radiotherapy to the head and neck region for malignancy. 5. Bruxism or TMJ dysfunction. 6. Intake of drugs affecting bone metabolism. 7. Uncontrolled diabetic patients. 8. Pregnant women.
COVID-19 Vaccine Education at the Point of Testing to Increase Vaccine Uptake in Vulnerable Communities in SE Louisiana

This project is a 2-year study to investigate vaccine hesitancy and vaccine completion among vulnerable communities in the Southeastern Louisiana region. This study will be used to track COVID-19 vaccine completion among patients who seek testing, either as in-person or purchasing at home COVID testing, from pharmacies, urgent cares and clinics using a rapid vaccine education model delivered at the point of care.

This project is a 2-year study to investigate vaccine hesitancy and vaccine completion among vulnerable communities in the Southeastern Louisiana region. This study will be used to track COVID-19 vaccine completion among patients who seek testing, either as in-person or purchasing at home COVID testing, from pharmacies, urgent cares and clinics. The proposal will introduce a rapid vaccination education model to be delivered at the point of COVID-19 testing by pharmacy students, pharmacy technicians, nurse's aides and other health care personnel and includes monitoring for COVID-19 vaccine completion among enrolled patients. Investigators anticipate an increase in COVID-19 vaccine completion rates for those who participate in the rapid vaccination education model.

Eligibility Criteria:
Inclusion Criteria:

* Unvaccinated adult participants, 18-99 years of age, able to provide informed consent, and to communicate in English, Spanish or Arabic. Also, individuals with incomplete vaccination (primary series or COVID-19 booster).

Exclusion Criteria:

* Persons fully vaccinated for COVID-19 (including primary series and boosters), persons with any documented allergies to components of the COVID-19 vaccines, or contraindications to receiving a COVID-19 vaccine.
Side Specific Withdrawal Times for Colonoscopy: Impact on Adenoma Detection in the Proximal and Distal Colon

Adenoma detection in the main goal of screening colonoscopy. In order to detect adenomas it is mandatory to spend a long enough time investigating the colonic mucosa. A minimum observation time of 6 minutes has been proposed as a quality criterion for screening colonoscopy. However, different locations of the colon (proximal, distal) may require specific observation time periods. The colon can be divided into a proximal (right) and distal (left) part. Until now, it is unclear whether observation time has a significant impact on adenoma detection in both parts of the colon. The aim of this study therefore is to conduct a trial in which side-specific observation times and adenoma detection rates are measured in order to investigate this correlation in particular for the right colon.


Eligibility Criteria:
Inclusion Criteria:

* indication for colonoscopy
* age ≥ 40 years

Exclusion Criteria:

* American Society of Anesthesiologists class IV or higher
* pregnant women
* indication for colonoscopy: inflammatory bowel disease
* indication for colonoscopy: polyposis syndrome
* indication for colonoscopy: emergency colonoscopy e.g. acute bleeding
* contraindication for polyp resection e.g. patients on warfarin
Does Radial Extracorporeal Shockwave Therapy Applied to the Achilles Tendon Influence Ankle Functionality?

Radial Extracorporeal Shockwave Therapy has been shown to restore shortened muscles and normalize fibrotic tissues in muscles or fascia. Shockwave therapy can soften fibrotic tissues and alleviate pain. While there are various methods to relax muscles and fascia, radial extracorporeal shockwave therapy can achieve good results in a short treatment time. Although there is research on the pain-related effects of radial extracorporeal shockwave therapy for conditions such as plantar fasciitis and knee osteoarthritis, there is a lack of literature on its functional effects. Therefore, this study aims to investigate the improvement of ankle functionality through the application of radial extracorporeal shockwave therapy.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who have ankle-related pain scores of 0 to 2 on the Numeric Pain Rating Scale (NPRS).
* Individuals with no functional impairment in the ankle.

Exclusion Criteria:

* Individuals who have undergone surgical procedures such as ankle joint arthrodesis.
* Individuals showing signs of functional impairment in ankle functionality.
* Individuals with ankle-related pain rated above 3 on the NPRS.
* Individuals with acute ankle fractures.
Intravenous Methocarbamol for Acute Pain After Spine Surgery

The goal of this target trial emulation is to evaluate the impact of intravenous (IV) methocarbamol on postoperative pain and opioid use in adults undergoing elective spine surgery. The main questions it aims to answer are:

* Does IV methocarbamol reduce pain in the 6 hours following surgery?
* Does IV methocarbamol decrease the need for opioid pain medications in the same period?

Participants who receive IV methocarbamol as part of their routine postoperative care will have their pain scores and opioid consumption tracked for 6 hours after treatment. Pain levels will be measured using standard assessments, and opioid use will be quantified in oral morphine equivalents.

The IMAPSS study is a target trial emulation evaluating the effect of intravenous (IV) methocarbamol on postoperative pain management and opioid consumption in adult patients undergoing elective spine surgery. The study employs a target trial emulation design to simulate the conditions of a randomized controlled trial using observational data extracted from electronic medical records. The main focus is to determine if administering IV methocarbamol within two hours after surgery reduces postoperative pain scores and opioid use.

Patients will be tracked from the point of their first recorded pain score in the Post-Anesthesia Care Unit (PACU) after surgery to assess for treatment assignment eligibility. Data will be collected at 15-minute intervals, which corresponds to the standard assessment frequency in Phase I PACU care, for up to 12 hours postoperatively for each patient. The primary analysis will use time-varying propensity score matching (TV-PSM) to control for baseline and time-varying confounders. Pain levels will be measured using a time-weighted average (TWA) of pain scores, and opioid consumption will be quantified in oral morphine equivalents (OME).

The primary analysis will utilize TV-PSM, with propensity scores estimated through a Cox proportional hazards model. Matching will create balanced treatment groups at each 15-minute interval. Generalized estimating equations (GEE) will then estimate the effect of IV methocarbamol on the primary outcome (TWA pain) and secondary outcome (cumulative OME) over a 6-hour postoperative period. As a sensitivity analysis, a marginal structural model (MSM) using inverse probability weighting (IPW) will assess the robustness of the findings to the time-varying confounder adjustment.

This study's findings will aim to inform evidence-based recommendations for postoperative pain management and opioid-sparing strategies, potentially providing safer alternatives to conventional opioid-based regimens.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Undergoing one of the following three elective spine surgeries: (i) Anterior Cervical Discectomy and Fusion (ACDF), (ii) Posterior Spinal Fusion, or (iii) Laminectomy, Laminotomy, or Discectomy

Exclusion Criteria:

* Emergency Surgery
* Pregnancy
* Sensitivity to methocarbamol (allergy)
* End-stage renal disease (ESRD)
* Myasthenia gravis
Treatment of Obesity With Vitamin D (40.000 IE Per Week for 1 Year)

The purpose of the study is to evaluate if supplementation with vitamin D in doses of 20.000IU per week and 40.000 IU per week will result in weight loss in obese subjects as compared to placebo during 1 year.

We will include 450 obese subjects that will be devided in 3 groups: 40.000IU cholecalciferol per week, 20.000 IU cholecalciferol per week, and placebo. All subjects will be given 500 mg calcium per day. There will be visits every tird month. In addition to weight reduction, we will also evaluate the calcium metabolism (blood test and urin samples), insulin sensitivity, muscle strenght, blood pressure and depression.

Eligibility Criteria:
Inclusion Criteria:

* BMI 30 - 40
* serum calcium \< 2.55 mmol/L

Exclusion Criteria:

* serious diseases
* reduced kidney function
* renal stone disease
* using psychopharmaca
* using drugs for weight reduction
Neurofeedback and Neural Plasticity of Self-Processing and Affect Regulation Circuits in Suicide Attempting Adolescents

A non invasive treatment study including participants at risk for suicide attempts and undergoing neurofeedback training. Neurofeedback is controlling your brain activity in real time inside the scanner.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents with a history of suicide attempts

Exclusion Criteria:

* Psychotic disorders.
* Primary substance use disorder.
* Primary anorexic disorder.
* Autism Spectrum Disorder.
Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers Syndrome

The purpose of this study is to investigate if combination treatment with Bosentan and Sildenafil to patients with Eisenmenger syndrome is beneficial.

Eisenmengers syndrome is condition with severe pulmonary arterial hypertension due to a shunting of blood from the left side of the heart to the right side of the heart. When the pressure in the pulmonary arteries levels the systemic blood pressure, blood begins to shunt from the right side of the heart to the left side of the heart leading to a condition with cyanosis, impaired physical capacity and increased mortality (Eisenmengers syndrome).

Several clinical trials have shown that there is a beneficial effect of treating patients with primary pulmonary arterial hypertension with Bosentan or Sildenafil and that a combination of these may have an additive or even synergistic effect. No clinical trials with Sildenafil and Bosentan has been conducted for patients with Eisenmengers syndrome. Observational studies and case stories indicate however that the effect of Bosentan or Sildenafil in patients with Eisenmengers syndrome may be as promising in these patients as in patients with primary pulmonary arterial hypertension.

We would like to examine the effect of treating patients with Eisenmengers Syndrome with a combination of Bosentan and Sildenafil.

The primary end point is change in physical performance measured with six minutes walking test.

Secondary end points is change in saturation, NYHA class, cardiac output (cardiac catheterization and innocor measurement), pulmonary vascular resistance (cardiac catheterization) shunt ratio (MRI), strain of right ventricle (BNP and echocardiography), quality of life and serum erythropoitin.

The trial is designed as a randomized, single centre, placebo controlled, double blind cross over study.

Twenty patients with Eisenmengers syndrome is included. All patients will be treated in three months with Bosentan. There after patients will be randomized to receive either Sildenafil (50 mg tid) or placebo as add on therapy for three month. Hereafter a cross over will be made and patients in combination treatment will receive only their native treatment and vice versa.

Examinations for primary and secondary endpoints will be made at baseline, before cross over and at the end of the study. All up titrating of medication will be performed during admittance. Patients will during the study period be close monitored with registration of adverse advents, physical examination and blood tests.

Eligibility Criteria:
Inclusion Criteria:

* Eisenmenger syndrome
* Negative pregnancy test

Exclusion Criteria:

* Elevated liver enzymes to more than 3´times normal value
* Hypotension (SBP \< 90 mmhg).
* Mandatory treatment with nitrates
* Myocardial infarction within 3 months
* Stroke within 3 months
* Known allergy to Bosentan or Sildenafil
* inherited degenerative diseases in retina
* Breast feeding
* Suspicion of risc of noncompliance.
Exercise Training and Endothelial Function in Type 1 Diabetes

Endothelial dysfunction and vasoreactivity disorders are early subclinical complications of type 1 diabetes (T1D). In a preventive setting, in T1D patients still free of complications, the research of non-pharmacological interventions to improve endothelial function appears fundamental.

In this randomized controlled trial, the effects of exercise training on endothelial function will be evaluated in T1D adults. Secondary objectives are to evaluate the exercise training effects on the micro and macrovascular function and exercise-induced tissue vasoreactivity and their possible neurometabolic consequences.

An improvement in vascular function, particularly endothelium-dependent, as well as in neurometabolic profile, through this non-pharmacological strategy is expected


Eligibility Criteria:
Inclusion Criteria:

* Covered by social security
* With a T1Diabete, diagnosed for at least 1 year, and free from macrovascular and microvascular diabetic complications.

Exclusion Criteria:

* type 1 diabetes diagnoses for less than 1 year
* MODY diabetes, mitochondrial diabetes or type 2 diabetes
* presence of macrovascular and/or microvascular diabetic complications (retinopathy, nephropathy, neuropathy ,...)
* Obesity (Body Mass Index \> 30 kg/m²
* Smokers
* Hypertension
* Disabling painful discomfort for trunk, upper or lower limb movements
* Active chronic disease or in remission (excluding type 1 diabetes)
* Head trauma in the past
"Impact of a Nursing Intervention in the Management of Oncological Patients With Lung Cancer Under Treatment With Immunotherapy"

Introduction. Lung cancer is very common worldwide with 2.09 million cases in 2018. Immunotherapy has become a mainstay in cancer treatment. There is insuficient knowledge about the impact of altered needs, as well as the interventions developed by the nurse that are aimed at cancer patients in immunotherapy treatment.

Objectives. Describe the needs of non-microcytic lung cancer patients in immunotherapy. And, evaluate the effectiveness of a nurse intervention program aimed at these patients in decreasing comorbidities, increasing satisfaction, early detection of symptoms and management of toxicities, quality of life and monitoring of anthropometric indicators.

Methodology. Phase 1: descriptive, cross-cutting and prospective study. Phase 2: quasi-experimental pre-post study. The sample is patients of the Hospital de la Santa Creu i Sant Pau, with non-microcytic lung cancer in treatment with Checkpoints inhibitor antibodies. The dependent variables: sociodemographic variables, clinical variables, satisfaction, quality of life, nutritional status, psychological impact, toxicities, number of unscheduled visits and health costs. Independent variable: nurse intervention program.

Implications for practice: Knowing the needs of patients in immunotherapy treatment will allow the development of a nurse care program to meet these needs and evaluate the program.


Eligibility Criteria:
Inclusion Criteria:

* Patient of legal age (\> or equal to 18 years), either male or female.
* Patient diagnosed with lung cancer regardless of subtype and / or stage. Except for small cell lung cancer, since this subtype of lung cancer is very different from the others and requires its own study.
* Patient receiving immunotherapy regardless of the treatment line.
* Patient who receives immunotherapy regardless of whether it is monotherapy or combination of chemotherapy.
* Patient who is able to consent to participate in the study.
* Patient who can read, understand and can communicate verbally.

Exclusion Criteria:

* Patient diagnosed with lung cancer synchronously with another neoplasm.
* Patients with speech disorders.
* Patients who do not understand or speak Spanish, Catalan or English.
Pan Tumor Rollover Study

Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.


Eligibility Criteria:
Inclusion Criteria:

* Signed Written Informed Consent.
* Eligible to receive continued study treatment per the Parent Study, including treatment beyond progression per investigator assessment in the Parent Study.
* On treatment hold in the Parent Study following long-lasting response or are eligible for treatment rechallenge as defined in the Parent Study.
* WOCBP and male participants who are sexually active must agree to follow instructions for method(s) of contraception as described below and included in the ICF.

Exclusion Criteria:

* Participant is not eligible for study treatment per the Parent Study eligibility criteria.
* Participants not receiving clinical benefit as assessed by the Investigator.
* Any clinical adverse event (AE), laboratory abnormality, or intercurrent illness which, in the opinion of the Investigator, indicates that participation in the study is not in the best interest of the participant.
* Other protocol-defined Inclusion/Exclusion Criteria apply
Balloon Palpation vs Loss of Resistance Syringe for Safe Endotracheal Tube Cuff Pressure; a Randomized Clinical Trial

This study is aimed at establishing whether use of loss of resistance syringe (LOR) that is traditionally used for identifying epidural space, is a better method for providing safe cuff pressures in adults intubated with cuffed endotracheal tubes. The conventional method is the use of pilot ballon palpation (PBP) to approximate cuff pressures but this is associated with airway damage.

The study hypothesis states that both the loss of resistance syringe method and the pilot balloon palpation methods achieve the recommended endotracheal tube intracuff pressures.


Eligibility Criteria:
Inclusion Criteria:

* American society of anesthesiologists (ASA) physical status classes I-IV

Exclusion Criteria:

* Known or anticipated laryngo-tracheal abnormalities.
* Patients with cough, sore throat, dysphagia and dysphonia.
* Patients in whom intubation is attempted more than twice