cyrilzakka/clinical-trials huggingface dataset:
The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer

The study was a three-arm, active-control, multi-centre, parallel group study.


Eligibility Criteria:
Main Inclusion Criteria:

* Patients, aged 18 years or over, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
* Baseline testosterone \>1.5 ng/mL.
* Life expectancy of at least 12 months.
Efficacy and Safety of Gastric Suctioning During Neonatal Resuscitation

The stomach of the newborn baby is often emptied soon after birth to prevent breathing problems (respiratory distress). Babies born with meconium-stained amniotic fluid and those with increased secretions associated with birth by C-section are thought to be at particular risk of breathing problems during the first minutes of life. Emptying the stomach by sucking out all its contents (gastric suctioning) is alleged to lessen the risk of aspiration and improve respiratory distress. This study will evaluate the usefulness of gastric suctioning during neonatal resuscitation.


Eligibility Criteria:
Inclusion Criteria:

* Term infant with meconium stained amniotic fluid or born by C-section

Exclusion Criteria:

* Prematurity
* Congenital Abnormality
Collagen Cross-linking in Infectious Keratitis Trial

The purpose of this study is to evaluate the efficacy of collagen cross-linking for treatment of infectious keratitis.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of corneal ulcer grade II or III (bacteria or fungal, or presumed bacterial or fungal)
* Age more than 6 year
* Patients can understand and can follow the study protocol

Exclusion Criteria:

* Pregnancy by history or urine test
* Evidence of herpetic keratitis
* Evidence of corneal perforation
* Evidence of autoimmune disease
* Known allergy to study medication
Evaluating a Family-based Nutrition and Garden Intervention in Rural Guatemala

This is a pilot quasi-experimental study to evaluate the impact of adding a family garden intervention to an existing wrap-around nutrition intervention for children with chronic malnutrition and their family. The existing nutrition intervention is provided by community health workers affiliated with Wuqu' Kawoq \| Maya Health Alliance. A single community in rural Guatemala will participate in the intervention, with the goal to recruit approximately 70 families in the combined nutrition/garden intervention. A nearby community, also participating in the nutrition intervention, will serve as a nonrandom contemporaneous control.

Aims of the study include:

1. Evaluate the impact of the garden intervention on maternal and child dietary diversity, child growth and household food insecurity.
2. Use the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to conduct a preliminary implementation analysis, to guide a future, well-controlled study.


Eligibility Criteria:
Inclusion Criteria:

* Children who are already scheduled to be enrolled in Maya Health Alliance's intensive home-based nutrition program (non-investigational, standard of care) who are 6-24 months of age at the time of enrollment with a height-for-age Z scores of \<= -2.5
* At least one caregiver willing to provide written informed consent
* Caregiver of a child enrolled in the study (for caregiver/head of household outcomes), including women who may be pregnant
* Planned residence in the study area for the next 18 months

Exclusion Criteria:

* Children with acute malnutrition (weight for length Z scores of \<= -2.0)
* Children with a severe medical illness that affects growth (e.g., heart disease, kidney disease, genetic condition) as determined by a Maya Health Alliance staff physician.
* Caregivers with cognitive impairments that prevent them from being able to provide informed consent
Effect of Sedatives on Perioperative Electroencephalogram in Elderly Patients Undergoing Spinal Anesthesia

In the present study, we observe perioperative findings of electroencephalogram in sedated and non-sedated elderly patients undergoing total knee arthroplasty under spinal anesthesia.

In the present study, we observe perioperative findings of electroencephalogram in sedated and non-sedated elderly patients undergoing total knee arthroplasty under spinal anesthesia. Electroencephalogram is performed before, during, and 1 day after surgery.

After the induction of anesthesia, sedation is performed according to the patient's request. If a patient want to be sedated during surgery, one of the three sedatives (dexmedetomidine, propofol, and midazolam) is administered.

Eligibility Criteria:
Inclusion Criteria:

* Eldery patients scheduled for spinal anesthesia

Exclusion Criteria:

* MMSE ≤ 23
* Hemodynamic unstability
* Liver disease
* Renal disease
Molecular and Diagnostic Classification of Non-Small Cell Lung Cancer From Fine Needle Aspirates

The goal of this study is to demonstrate the feasibility of using a novel, validated panel of Non-Small Cell Lung Cancer (NSCLC) histology-predictive genes (the "A/S signature) as a diagnostic tool for use with small-volume Fine Needle Aspirate (FNA) biopsies.

Objectives:

1. To establish FNA biopsy requirements for FNA-based subtype classification of NSCLC.
2. To define a "fixed statistical model" of histologic subtype prediction in NSCLC.

Study methods: To establish FNA biopsy requirements for gene expression-based subtype classification of NSCLC, patients with presumed newly diagnosed NSCLC, where radiographic studies and clinical description favor a probable diagnosis of NSCLC, will undergo FNA biopsy according to current standard techniques . For this part of the study, approximately 40 biopsies of confirmed NSCLC will be collected for analysis.

To define a fixed statistical model of histologic subtype prediction in NSCLC, we will prospectively collect 50 FNAs. These FNAs will represent Adenocarcinoma (AC) and Squamous Cell Carcinoma (SCC) cases at a ratio of approximately 1:1. Additional cases of not otherwise specified (NOS), should they be encountered, may also be collected for later analysis. FNA samples qualified based on cell number or ribonucleic acid (RNA) yield (depending on the findings of our primary objective)will be assayed on the QGS platform.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a diagnostic FNA by the following diagnostic modalities utilizing FNA: Trans-thoracic Needle Biopsy (TNB), Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA), Trans-esophageal Ultrasound Scanning with FNA (EUS-FNA).
* Patients must have radiographic evidence for presumed lung cancer or have a previously diagnosed NSCLC with potential recurrence. Patient undergoing FNA of potential NSCLC metastatic lesions are also included (e.g., patients with hepatic metastases).
* Age \>18 years. Used to define adult age who can independently provide consent.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients whose FNA biopsy is unable to provide subtype classification by pathology or is non-diagnostic.
The Effect of Motivational Support Program Applied to Adolescents on Sleep Quality and Academic Achievement

It was planned as a randomized controlled experimental study with a single-blind technique, pretest-posttest control group and repetitive measurements, in order to determine the effect of motivational support program applied to adolescents and education on sleep quality.


Eligibility Criteria:
Inclusion Criteria:

* No language disorders
* No hearing disorders
* No mental disorders
* Bad sleep quality
* No chronic disease

Exclusion Criteria:

* Sleeping pill
* Psychiatric illness
Laparoscopic Versus Open Appendectomy

Comparison of open and laparoscopic appendectomy

Adult patients with presumptive diagnosis of acute appendicitis were were operated by laparoscopic appendectomy or open appendectomy group during a three-year period (between 2007 and 2009).

Eligibility Criteria:
Inclusion Criteria:

* patients older than 16 years with presumptive diagnosis of acute appendicitis

Exclusion Criteria:Appendectomy performed during diagnostic laparoscopy and incidental appendectomies patients with:

* cirrhosis
* ascites
* coagulation disorder
* diffuse peritonitis
* shock on admission
* large ventral hernia. Appendectomy performed during diagnostic laparoscopy and incidental appendectomies were also excluded
Correlation of FeNO, Blood Eosinophils, Bronchoalveolar Lavage Findings and Bronchial Epithelium Histopathology in Patients With Chronic Obstructive Pulmonary Disease and Asthma

Scientific research focuses on "eosinophilic inflammation" as it seems to guide the therapeutic regimen in patients with asthma and COPD. The primary objective of this prospective trial is to evaluate which parameter(s) best reflects eosinophilic inflammation by correlating tissue eosinophils (endobronchial biopsy, protected specimen brush sampling) with FeNO, peripheral blood eosinophils, and eosinophils in the bronchoalveolar lavage of patients with obstructive pulmonary disease.

This is a multicenter prospective trial. Enrollment will continue until 150 patients with chronic obstructive pulmonary disease and 50 patients with severe asthma have been entered into this trial and have completed bronchoscopic evaluation. In this trial, the following parameters are to be evaluated:

* Blood eosinophils (absolute and relative)
* FeNO
* Eosinophils in bronchoalveolar lavage
* Tissue eosinophilia (protected specimen brush sampling, endobronchial biopsy)

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of COPD or asthma (according to the guidelines)
* Age \>18 years
* Indication for bronchoscopy for medical reasons (not study-related)
* Ability to provide informed consent

Exclusion Criteria:

* paO2 \<60 mmHg on 4L 02 /min, paCO2 \> 55 mmHg on room air
* FEV1 \<20%
* Pulmonary infection or exacerbation within the last 4 weeks
* Additional pulmonary diseases (pneumonia, lung cancer, tuberculosis, interstitial lung disease)
* Contraindication for BAL, PSB sampling or endobronchial biopsy
* Current use of anticoagulants that can not be stopped for bronchoscopy
* Heart failure with left ventricular ejection fraction \<30%
* Myocardial infarction in previous 6 months
* Significant pulmonary hypertension (PAPS \>45 mmHg, right heart failure \[echocardiography\] and/or PAPm \>35 mmHg \[right heart catheter\])
Comparison of Plant and Animal Proteins on Amino Acid Concentrations

The study purpose is to assess various protein blends, which differ in protein quality, and the impact on blood amino acid response in male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, resistance-trained adult men 18-35 years of age, inclusive, at the screening visit.
* BMI between 18.5 and 29.9 kg/m² inclusive at sceening
* Self-reported resistance training experience of no less than two years , and have participated in resistance training of at least 1h two days per week for the past six months.
* Willing to abstain from any protein supplements for 1 day prior to the study intervention phase (i.e. from the randomised visit, Visit 2)

Exclusion Criteria:

-
Intensification of Care to Improve Adherence to Anti-hypertensives

The aim of the study is to evaluate the effectiveness of a social-psychological intervention to improve anti-hypertensives adherence in primary care. Its is a pragmatic clinical trial.

We will study two groups of 198 people with hypertension treated in ten health care units. One group will receive usual care dispensed in units (control). The other group (intervention) will be offered six individual assistance with health care worker physician or nurse) during the period of 9 months with a minimum interval of 30 days, plus 9 monthly visits structured by community health agents. Adherence will be measured in both groups at baseline and months 3, 6, 9 and 12, through validated questionnaire and pill count. Also evaluated clinical outcome measures (blood pressure, hospitalizations and deaths). The analysis will be done by intention to treat comparing adherence measures and clinical outcome between groups (Student t test and chi-square test) and within groups over time (paired t test and McNemar). It will be accepted p value \<0.05.

Eligibility Criteria:
Inclusion Criteria:

* persons with hypertension aged 18 years and older

Exclusion Criteria:

* those with physical or mental impaired that cannot go to health care units or cannot answer a questionnaire
* pregnants
Different Endoscopic Gastric Cancer Risk Assessments

The Kimura-Takamoto classification established in Japan can observe the extent of gastric atrophy in real-time under endoscopy, and diffuse atrophy also indicates an increased risk of gastric cancer. Recent studies have found that the evaluation of intestinal metaplasia score (EGGIM score) of various stomach parts by electronic staining can well identify OLGIM III\\ IV patients. Although the Kimura-Takamoto classification and EGGIM score can evaluate the risk of gastric cancer in patients, only in cross-sectional studies, it is not clear the diagnostic value of risk assessment in population screening. Early gastric cancer has the characteristics of hidden lesions and a high rate of clinical missed diagnosis. Concentrating high-risk groups through risk scores is expected to guide endoscopic doctors to conduct a targeted careful examination. However, it is not clear whether Kimura-Takamoto classification and EGGIM score can improve the detection rate of early gastric cancer in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 40-80 years undergoing gastroscopy
* Patients intend to undergo ESD treatment

Exclusion Criteria:

* patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who cannot participate in gastroscopy
* Patients with previous surgical procedures on the stomach
* patients with contraindications to biopsy
* Patients who refuse to sign the informed consent form.
Study to Determine the Effectiveness of Pillar Palatal Implants to Treat Obstructive Sleep Apnea

The Pillar palatal implant procedure is a minimally invasive and commercially available treatment for mild to moderate obstructive sleep apnea (OSA) in the United States and Europe. The implants are placed into the soft area in the roof of the mouth providing support to the soft palate. This research is being done to compare daytime sleepiness and sleep related quality of life after palatal implants.

Patients will be enrolled into the study based on sleep study results, a physical exam and inclusion/exclusion criteria. Once enrolled, patients are randomized into either the Pillar palatal implant group or a placebo/sham group.

In both cases, patients come into the office for placement of the implants. This is an outpatient procedure. Patients are followed at one week, one month and 3 months. At each follow-up visit, patients will undergo a physical exam and complete questionnaires related to sleep and quality of life. Patients will also undergo reaction time testing on hand-held device similar to a pocket video game. At the three month visit, patients will return to the sleep lab for another sleep study.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Body Mass Index equal to 32 or less
* Apnea-Hypopnea Index greater than/equal to 10 and less than/equal to 30
* Symptoms of daytime sleepiness

Exclusion Criteria:

* Septal deviation or nasal obstruction
* Nasal polyps
* Severe seasonal allergies
* Soft palate length insufficient to accommodate implants
* Fujita Modified Mallampati Class 3
* Large tonsils
* Lingual tonsil hypertrophy
* Hypopharyngeal obstruction
* Previous pharyngeal surgery
* Previous upper respiratory tract cancer or radiation therapy
* Active respiratory tract infection
* Dysphagia or speech disorder
* Neurologic disorder
* Unstable psychiatric disorder
* Pregnant or breastfeeding
* History of falling asleep driving or MVA due to sleepiness
* Currently on CPAP therapy or other device for OSA
* Other sleep disorders
Long-term Outcome of RIPC After IV Thrombolysis in AIS Patients

The goal of this observational study is to learn about the long-term efficacy of our previous study in acute ischemic stroke(AIS) patients who underwent either remote ischemic postconditioning(RIPC) or sham treatment after intravenous thrombolysis. The main questions it aims to answer are:

* Dose the RIPC treatment combined with IV thrombolysis can improve the long-term functional outcome in AIS patients?
* Dose the RIPC treatment combined with IV thrombolysis can improve the incidence rates of all-cause and cardiovascular mortality, recurrent stroke/TIA, new-onset clinical AF on this long-term follow-up? A single rater (A.E.P.) trained by an experienced stroke physician (S.T.E.) contacted patients, relatives, and family physicians to gather all available medical information on the following issues: 1) survival status, 2) date of death in those who died (based on information of the treating physicians), 3) mRS score at the time of the interview, 4) recurrent stroke/TIA, 5) new onset atrial fibrillation, 6) other cardiovascular events, including myocardial infarction, pulmonary embolism, deep venous thrombosis, peripheral arteriopathy.

Researchers will compare RIPC group and control group to see if the RIPC treatment have a long-term effect in AIS patients.


Eligibility Criteria:
Inclusion Criteria:

* All patients who completed the previous interventional rater-blinded controlled study were invited for the follow-up session.
Acute Lung Injury in Children: Epidemiology and Natural History. PEDIATRIC ALIEN.

The investigators propose to perform a one-year prospective audit of all Acute lung injury (ALI)and cute respiratory distress syndrome (ARDS) pediatric patients managed in several ICUs in Spain. The investigators intend to collect data from all children (from 1 month to 18 years of age) admitted with or developing ALI/ARDS with the aim to understand the epidemiology and natural history of acute lung injury in the pediatric setting. These ICUs are scattered through the Spain and are representative of the demographic differences across the country.

Acute lung injury (ALI) is a clinical syndrome of rapid onset of non-cardiogenic pulmonary edema manifested clinically by hypoxemia (PaO2/FiO2≤300 mmHg) and bilateral pulmonary infiltrates. When the hypoxemia is severe (PaO2/FiO2≤200 mmHg) it is termed the acute respiratory distress syndrome (ARDS). It represents a significant public health issue. Patients with ALI or ARDS require admission into critical care units for advanced life support and utilize considerable health care resources.

An immense plethora of translational knowledge has been acquired since the first description of ARDS in 1967. At the present, estimates of the incidence of ARDS and ALI in children are unknown. In adults, the estimates of ALI/ARDS incidence have varied widely, and the true magnitude of this health problem still remains unclear. Current estimates of the incidence of adult ALI/ARDS range from 15 to 80 cases per 100.000 population, or almost 40.000 cases per year in Spain. Combined mortality rates for adult ALI/ARDS range between 30-45% but it is not clear whether this figures can be translated in the pediatric population. ALI and ARDS occur as a complication or as the primary cause of critical illness in patients, usually after severe infection or trauma.

Published epidemiological studies on ALI and ARDS in the last 20 years are difficult to compare. Some reports have used different definitions for ALI and ARDS and others have evaluated the incidence during a short period of time (from days to several weeks) and then extrapolated their data to estimates of a one-year incidence. Very few studies have collected information for an entire year, and none of them have evaluated the degree of hypoxemia under standard ventilatory settings, as it has been proposed recently by the HELP Network (Am J Respir Crit Care Med 2007; 176:795-804).

Eligibility Criteria:
Inclusion criteria:

* All patients, age ranging from 1 month to 15 years old
* Must be able to meet the American European Consensus definition of ALI and ARDS(no indication of heart failure or a pulmonary capillary wedge pressure of greater than 18 mmHg, with pulmonary infiltrates in all four quadrants and a PaO2/FIO2 of \> 200 to \<300 mmHg (ALI) or ? 200 mmHg (ARDS).

Exclusion criteria:

* Younger than 1 month or older than 15 years old
* Cardiac disease
A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours

This first-in-human study evaluates safety, tolerability and distribution of \[225Ac\] FPI-1966, \[111In\]-FPI-1967, and vofatamab in patients with FGFR3-expressing solid tumors.

In phase 1, cohort 1, the potential impact of pre-dose administration of vofatamab on the dosimetry, PK, safety, and tolerability of \[225Ac\]-FPI-1966 and \[111In\]-FPI-1967 will be evaluated.

In later phase 1 cohorts, \[225Ac\]-FPI-1966 will be evaluated at ascending dose levels. Participants will receive \[111In\]-FPI-1967 during the imaging screening period to assess FGFR3 expression and to determine biodistribution and estimate radiation exposure to critical organs.

Once the recommended phase 2 dose (RP2D) or regimen is established and confirmed, three tumour-agnostic expansion cohorts may be initiated in parallel.

Eligibility Criteria:
Key Inclusion Criteria:

* Signed ICF prior to initiation of any study-specific procedures
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Histologically and/or cytologically documented diagnosis of locally advanced, inoperable, or metastatic solid tumours
* Refractory to all standard treatments, or for whom standard treatment is not available, or tolerable, or is contraindicated, or the participant refuses standard therapy
* Measurable disease per RECIST v. 1.1
* Available tumour tissue (archival or fresh biopsy)
* Adequate bone marrow, heart, liver, and kidney function

Key Exclusion Criteria:

* Prior systemic radiopharmaceutical therapy within six months prior to the first dose of \[111In\]-FPI-1967
* Prior radiation therapy (RT) to bone marrow \> 20 Gy
* RT within 30 days prior to the first dose of \[111In\]-FPI-1967
* Prior anti-cancer treatment (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, or investigational agents) within a certain amount of time prior to administration of the first dose of \[111In\]-FPI-1967
* Concurrent serious co-morbidities that could limit participants' full participation and compliance
Italian Multicenter Database for Open Conversions After EVAR

Late endovascular abdominal aneurysm repair (EVAR) complications not amenable to endovascular correction can undergo either late open conversion (LOC) or semi-conversion (SC).

LOC is defined as a total or partial endograft explantation \>30 days after the initial EVAR.

SC is defined as open or laparoscopic surgery for endoleak (EL) correction with complete endograft preservation.

The aim of this study is to collect in a prospective database the technical aspects of a multicenter experience of LOC and SC, and to analyse early and long-term outcomes of these two treatments.


Eligibility Criteria:
Inclusion Criteria:

* open or laparoscopic surgery for EVAR complications, with or without endograft explantation

Exclusion Criteria:

* endovascular reinterventions
* extra-anatomical bypass surgery (e.g. femoro-femoral crossover bypass) not associated with direct aorta/endograft surgery