cyrilzakka/clinical-trials huggingface dataset:
Comparison of 68Ga-FAPI-46 PET and 18F-FDG PET in Lung Cancer

This is a prospective, single-center, single arm, open label study to evaluate the performance of 68Ga-FAPI-46 for the diagnosis of primary and metastatic lesions of lung cancer with comparison to 18F-FDG PET.

FDG-PET imaging is recommended by clinical guidelines for staging of lung cancer; however, there are still limitations of FDG-PET in lung cancer staging due to false-positive and false-negative findings. 68Ga-FAPI PET images have shown high diagnostic performance with high tumor-to-background ratio in various cancers. The purpose of this study is head-to-head comparison of 68Ga-FAPI-46 PET and 18F-FDG PET for the diagnosis and staging or re-staging of lung cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 20 years
2. Informed consent obtained from patients and families
3. Patients with histology confirmed lung cancer or patients with GGO on chest CT planned to have biopsy or surgery
4. Patients scheduled to undergo FDG-PET examination
5. Performance status: 0, 1, 2, 3

Exclusion Criteria:

1. Contraindication to FAPI-PET and FDG-PET such as pregnant, or lactating patients
2. Patients with mainly malignant pleural effusion without other measurable lesions
3. Undergoing irradiation at accrual
4. Active infection or other serious underlying medical conditions not compatible with study entry
5. History of significant neurological or psychiatric disorders including dementia that would prohibit the understanding and giving of informed consent
Vaccination Against Influenza to Prevent Cardiovascular Events After Acute Coronary Syndromes

Cardiovascular disease has a great burden in the context of public health, as well as the low pharmacological adherence of patients who have chronic non-transmissible diseases. However, the investigators do not have data on the efficacy of vaccination to reduce cardiovascular events in the acute coronary syndromes, and the few studies evaluating the cardioprotective potential of the influenza vaccine were conducted in countries with well defined seasonalities, divergent of Brazil, that presents a constant viral circulation during all months of the year and distinct among its regions. Therefore, study evaluating higher dose vaccination in a period that contemplates the seasonality of the influenza virus in Brazil may bring important findings to different scientific gaps, as well as clarify questions about the possible benefit of doubled vaccination - which does not present contraindications - immediately after a atherothrombotic event. If it shows real benefit, it could also be a future therapeutic tool adjuvant to traditional drug therapy in the prevention of cardiovascular events.

Phase III, randomized, controlled, multicenter, open-label, superiority, 1:1 allocation, blind assessment of clinical outcomes and intention-to-treat analysis clinical trial to determine whether increased doses(double dose) of influenza vaccine in the hospital phase, when compared to usual dose vaccination (30 days of randomization), decreases the risk of cardiovascular and respiratory events. Hospitalizations due to COVID-19 are excluded from the respiratory infection component of the primary outcome.

Eligibility Criteria:
Inclusion Criteria

* Age \>= 18 years and older
* Acute coronary syndrome in hospital phase.

Exclusion Criteria:

* Participation in another clinical trial with vaccines;
* Refusal to provide consent;
* Hypersensitivity and/or anaphylaxis to any component of the vaccine, or Guillain-Barré within 6 weeks after previous influenza vaccine;
* Have already received the influenza vaccine with the same strains used in the study within the last 12 months of inclusion in the study
* Breastfeeding women;
* Pregnant women;
* Presenting an acute coronary syndrome during months of December, January, and February.
* Acute coronary syndrome hospitalization \>7 days
Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance (Vitamin C Study)

The main purpose of research is to examine and understanding the development of hypertension in obese adults with insulin resistance. Findings from our studies will identify unique mechanisms that can be targeted to limit increases in vascular dysfunction and reduce the excessively high prevalence of hypertension and risk for cardiovascular disease (CVD).

This study is testing the health of the blood vessels and the activity of the nerves that control the blood vessels in adults with insulin resistance. The extent to which ascorbic acid (Vitamin C) improves the function of the blood vessels will be determined. The primary outcome is blood pressure, which is the result of blood vessel health and activity of the nerves, and the reduction in blood pressure that is observed with ascorbic acid.


Eligibility Criteria:
Inclusion Criteria:

1. Obese: BMI \>30 m/kg2
2. Middle-aged: 35-65 years
3. Participants must be willing and able to discontinue taking any vitamin C or E supplements or omega-3 fatty acids beginning 2 weeks prior.
4. Able and willing to provide written informed consent

Exclusion Criteria:

1. Diabetes mellitus: fasting glucose \< 1267 mg/dL and/or HbA1c \< 6.5%
2. Currently taking a statin or antihypertension medication
3. Hyperlipidemia: Fasting triglycerides \< 250 mg/dL
4. Hypertension: \<130/80 mmHg
5. History of heart disease (e.g., myocardial infarction, stent)
6. History of vascular disease (e.g., bypass, stroke)
The Effects of Smoking on Mortality in Patients With Acute Respiratory Syndrome Coronavirus 2 Infection

This is a retrospective single centered study that was done in the ICU on patients with Covid-19 between 16th of March -16th of May in 2020 Retrospective records will be examined by examining the electronic data files of the patients.

There were two groups as smoker and non-smoker.

The aims of the present study is to see the effects of smoking prevalence, the length of stay regarding the usage of cigarettes, and the effects on the mortality of COVID-19 in our intensive care unit(ICU).

This is a retrospective single centered study that was done in the ICU on patients with Covid-19 between 16th of March -16th of May in 2020. The demographic data, comorbidity status, the units they were accepted from, clinical symptoms , respiratory support, prevalence of smoking, length of stay in the ICU and mortalities of the patients weill be recorded. There are two groups as smoker and non-smoker.

Eligibility Criteria:
Inclusion Criteria:

* All the patient's data are diagnosed with acute respiratory syndrome Covid-19 over 18 years old

Exclusion Criteria:

* Patients under 18 years of age
Iron and COVID-19 Vaccine Response

Vaccines often underperform in Africa compared to high-income countries. Why vaccines do not work as well in Africa remains uncertain. Malnutrition likely plays a role. Our study objective is to assess whether iron deficiency anaemia in young women impairs their immune response to the COVID-19 vaccine, and whether iron treatment improves their response.

Group 1 (immediate iron treatment) will receive iron treatment before vaccination. Women in both groups will receive the 1st dose of the COVID-19 vaccine. Vaccine response will be measured 28 and 56 days after the first vaccine administration in both groups. At 28 days, participants will receive the 2nd dose of the COVID-19 vaccine. Group 2 (delayed iron treatment) will receive iron treatment at study end.

Eligibility Criteria:
Inclusion Criteria:

18-55 years old Zinc protoporphyrin \> or equal 40 mmol/mol heme hemoglobin \< or equal 109 g/L no malaria no known HIV infection no medical condition that precludes study involvement no iron supplementation 1 week prior to study start no recent tuberculosis infection no vaccination of yellow fever or influenza prior to enrolment not pregnant

Exclusion Criteria:

-
Diagnosing Invasive Aspergillosis by Polymerase Chain Reaction (PCR) Based Investigation of Bronchoalveolar Lavage Samples During Antifungal Therapy

Invasive pulmonary aspergillosis (IPA) remains a major cause for morbidity and mortality in patients (pts) with hematologic malignancies. As culture-based methods only yield results in a minority of patients, using non-culture-based methods for detection of aspergillosis in clinical specimens becomes increasingly important. Analyzing bronchoalveolar lavage (BAL) samples with polymerase chain reaction (PCR) is promising, however, the influence of current antifungal drugs on the performance of this diagnostic tool remains controversial.

The aim of the trial is to elucidate on the performance of BAL PCR under antifungal treatment.

Invasive pulmonary aspergillosis (IPA) remains a major cause for morbidity and mortality in patients (pts) with hematologic malignancies. As culture-based methods only yield results in a minority of patients, using non-culture-based methods for detection of aspergillosis in clinical specimens becomes increasingly important. Analyzing bronchoalveolar lavage (BAL) samples with polymerase chain reaction (PCR) is promising, however, the influence of current antifungal drugs on the performance of this diagnostic tool remains controversial.

The aim of the trial is to elucidate on the performance of BAL PCR under antifungal treatment.

Patients with high risk of invasive aspergillosis and lung infiltrates are sampled via BAL, the sample is analyzed for fungal DNA by Apsergillus specific PCR. Clinical data including treatment data is assessed and evaluated.

Eligibility Criteria:
Inclusion Criteria:

* immunocomprimised patients with high risk of invasive aspergillosis and lung infiltrates
* informed consent

Exclusion Criteria:

* Children under the age of 5 years
* Informed consent not available
Comparison of Two Tooth-borne Expanders in Rapid Maxillary Expansion

This study will assess the dentoalveolar effects and impact on quality of life of two types of maxillary expanders in orthodontic patients with permanent dentition, from 12 to 16 years old. Half of participants will be treated using the Hyrax expander, while the other half will use the mini Hyrax expander. The null hypothesis is that there is no difference between dentoalveolar effects and impact on quality of life of the two protocols.

Transverse maxilla deficiency is characterized by narrowing of the maxillary arch with important functional and esthetic impact. In individuals which have not reached bone maturity, a rapid expansion of the maxilla by using tooth-borne expanders as Haas and Hyrax appliance are efficient and safe. A presentation of favorable results for the "mini-Hyrax inverted" expander with a small screw in the transversal correction of the maxilla in patients with cleft lip and palate, besides improving the comfort and the teeth cleaning, provoked an idea of application of this small screw to correct posterior crossbite in individuals without cleft lip and palate. The objective of this study is to compare the dentoalveolar effects and impact on quality of life of two types of maxillary expanders in adolescent patients with permanent dentition and active bone growth. The sample size calculation indicated a total sample of 28 individuals. Taking into account the loss of sample during the study, 34 subjects that have posterior crossbite and age from 12 to 16 years, will be recruited at the Dental School, Pontifical University Catholic of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil. These patients will be randomly divided into two groups, Hyrax and mini Hyrax, with 17 patients each. Digital models of both dental arches will be obtained by intraoral scanning precede the procedure (T0) and at the end of the retention period, after appliance removal (T2). OHIP-14 Oral Health Impact Profile Questionnaires, validated in Portuguese, will be applied before expansion (T0), after an expansion (T1) and at the end of the retention period (T2). In digital dental models, maxillary first and second bicuspids and first molar width, and rotation and inclination of maxillary first bicuspids and first molars will be assessed. After the normality test, the appropriate statistical test will be used in the intergroup comparison. A significance level of 5% will be regarded for all tests.

Eligibility Criteria:
Inclusion Criteria:

* Maxillary permanent dentition, except canines
* Ages ranging from 12 to 16 years old;
* Maxillary constriction associated to posterior crossbite uni or bilateral.

Exclusion Criteria:

* Cleft lip and palate;
* Craniofacial syndromes;
* Carious lesions;
* History of previous orthodontic treatment.
Cetuximab, 5-FU and Radiation as Neoadjuvant Therapy for Patients With Locally Advanced Rectal Cancer

The standard treatment for rectal cancer is to receive the chemotherapeutic drug 5-fluorouracil (5-FU) with radiation therapy before having surgery to remove the rectal cancer. This is known as neoadjuvant chemoradiotherapy. The purpose of this research study is to determine if Cetuximab improves the benefits of neoadjuvant chemoradiotherapy when given with 5-FU and radiation therapy.

The epidermal growth factor receptor (EGFR) present in normal and tumor cells is involved in signaling pathways affecting cellular growth, differentiation, proliferation and programmed cell death. Overexpression of EGFR has been associated with poorer prognosis in colorectal cancer. Cetuximab targets and blocks EGFR and has been shown to be safe and effective in treating colorectal cancer and head and neck cancers.

The primary hypothesis is that cetuximab in combination with standard 5-FU and radiation as neoadjuvant therapy would improve pathological complete response (pCR) compared to the historical rate (30% versus 10%). The regimen would be considered promising if 5 or more of 25 evaluable participants achieve pCR. The probability of observing this outcome is 0.91 and 0.10 if the true pCR rate is 30% and 10%, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the rectum that begins within 15cm of the anal verge as determined by sigmoidoscopy and/or colonoscopy, with no evidence of distant metastatic disease. A complete colonoscopy to the cecum is recommended prior to initiating protocol therapy.
* Staging with transrectal ultrasound or endorectal coil Magnetic resonance imaging (MRI) to confirm clinical stage of T3 or T4 or lymph node positive rectal adenocarcinoma
* Tumor is K-ras wildtype by method of choice at respective institution (testing codons 12 and 13)
* Performance status: Eastern Cooperative Oncology Group Performance Score (ECOG PS) less than or equal to 2
* 18 years of age or older
* No evidence of metastatic disease by abdominal/pelvic (Computed tomography) CT and chest imaging
* Adequate bone marrow, renal,and hepatic function as outlined in protocol
* All patients will be evaluated by a surgeon and considered a candidate for definitive surgery
* Coumadin or heparin management for line care of other indications is permitted. The International Normalised Ratio (INR) will be monitored weekly in patients taking coumadin.

Exclusion Criteria:

* Prior treatment for this malignancy
* Prior history of pelvic radiation therapy
* Prior history of 5-FU based or EGFR receptor inhibitor therapy
* Prior history of an allergic reaction to a monoclonal antibody
* Uncontrolled serious medical or psychiatric illness
* Significant history of uncontrolled cardiac disease
* Sexually active women of childbearing potential must use an effective method of birth control during the course of the study
* Unwilling to agree to pre and post-cetuximab sigmoidoscopy and biopsy
Antisense Oligonucleotide Treatment for PCARP Disease Due to Mutation in FLVCR1

The goal of this clinical trial is to evaluate a specific antisense oligonucleotide medication in one patient with posterior column ataxia with retinitis pigmentosa. The main question it aims to answer is: what is the safety and tolerability of this medication in a single participant.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent/assent provided by the participant (when appropriate), and/or participant's parent(s) or legally authorized representative(s).
* Genetically confirmed FLVCR1-related disease.
* Ability to travel to the study site and adhere to study-related follow-up examinations and/or procedures and provide access to participant's medical records.

Exclusion Criteria:

* Allergy to any of the ASO components
* Participant has any condition that in the opinion of the Site Investigator, would ultimately prevent the completion of study procedures.
Videolaryngoscopes for Tracheal Intubation

The primary end point of this study is the feasibility of intubation. The secondary end-points are the success to intubate in the first attempt, the intubation time, the Cormack and Lehane score view, the comparison of the intubation difficulty scale (IDS) score and the need for maneuvers to aid the endotracheal intubation comparing Imago V-Blade ® and Glidescope®.

Patients admit to the operation rooms of University of Naples "Federico II" and requiring endotracheal intubation for general anesthesia will be consecutively screened for the presence of predicted difficult airway according Italian guideline. According to this guideline, the presence of one or more of the following parameters may be considered highly predictive of difficult intubation: Mallampati class 3-4, inter-incisor distance \< 30 mm, mental-thyroidal distance \< 60 mm, large prominence of superior incisors above inferior incisors uncorrectable with jaw-thrust, reduced head and neck motility, and reduced mental-jugular distance. Patients matching more then 1 of the previous criteria stated by Italian guideline will be included in this case controlled study. Patients 1) without criteria for predicted difficult airway; 2) those requiring emergency surgery; 3) aged \< 18 years; or 4) declined consent to participate, will be excluded from this study.The primary end-point was the comparison of the intubation difficulty scale (IDS) score. The secondary end-points were the learning curve, the intubation time, the Cormack and Lehane score view, and the need for maneuvers to aid the endotracheal intubation comparing different videolaryngoscopes available in our department. Two anesthesiologists with 10 years of experience in conventional endotracheal intubation and trained for video assisted intubation will perform the maneuvers.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Mallampati class 3-4
* inter-incisor distance \< 30 mm
* mental-thyroidal distance \< 60 mm
* large prominence of superior incisors above inferior incisors uncorrectable with jaw-thrust -reduced head and neck motility
* reduced mental-jugular distance.

Exclusion Criteria:

* \< 1 criteria for predicted difficult airway
* emergency surgery
* age \< 18 years
* declined consent to participate
Comparing Visual Outcomes in Matched Patients Receiving a Low Cylinder Power Toric IOL or a Non-toric IOL

The purpose of the study is to determine if visual function is improved with implantation of a low-cylinder toric intraocular lens, relative to a non-toric intraocular lens.

The Clareon(R) T2 IOL and the Clareon (R) non-toric IOL will be randomly implanted in subjects determined to be appropriate for the T2 IOL. Visual acuity, low contrast acuity and contrast sensitivity will be measured 3 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* candidate for cataract surgery, suitable for implantation with a low cylinder toric IOL

Exclusion Criteria:

* pathology that would confound outcomes, previous ocular surgery
Comparison of Restricted Versus Unrestricted Kinematic Alignment in 1ry TKA

Knee osteoarthritis is a growing socioeconomic burden because of the ageing and obesity. By 2030, the majority of individuals undergoing knee arthroplasty in USA will be those younger than 65 years, with up to 1 million achieved annually.

The definitive treatment for knee joint degeneration is total knee arthroplasty.

Furthermore, the commonest technique is neutral mechanical alignment total knee arthroplasty. Latest studies have revealed that the mechanical alignment technique repeatedly causing substantial anatomical alterations with a widespread of complex collateral ligament imbalances, which are not repairable by collateral ligament release. Consequently, the total knee arthroplasty individuals walk with an abnormal gait, and they do not experience a normal knee joint. This may be one of the causes that up to 20% of total knee arthroplasty individuals are disappointed, and over 50% may have remaining symptoms.

Consequently, the conventional mechanical alignment technique has been recently challenged by a new alternative technique, namely unrestricted kinematic alignment proposed by Howell, as a possible solution to the high dissatisfaction following total knee arthroplasty, aiming at reproducing the constitutional tibiofemoral tridimensional alignment and knee laxity. It is almost a pure bone procedure with only exceptional collateral ligament release, which has been shown to reliably position knee components.

The restricted kinematic alignment protocol suggested by Vendittoli has been developed as an alternative to the unrestricted kinematic alignment for patients with an outlier or atypical knee anatomy. The restricted kinematic alignment is founded on five principles: hip-knee-ankle angle should be maintained within ± 3° postoperatively; a limitation to a maximum of 5° for lateral distal femoral angle and medial proximal tibial angle may be considered; restoration of collateral ligament balance should be achieved without the gap balancing technique; native femoral anatomy preservation is suggested over tibial one to maintain knee biomechanics; resurface resection must be accomplished on the unworn side with a thickness equivalent to the width of the implant;cut fine-tuning may be sought at the worn side.

Eligibility Criteria:
Inclusion Criteria:

-Patients suffered from end stage knee osteoarthritis of grade four according to Kellgren-Lawrence classification in at least one of the three knee compartments, who have an osteoarthritic knees of varus Coronal Plane Alignment of the Knee classification

Exclusion Criteria:

1. Any valgus malalignment of the knee joint.
2. Malalignment more than 10° or less than 3° varus of knee joint.
3. Ligamentous laxity of the affected knee (medial or lateral collateral ligaments)
4. any tumors or secondary neoplasia diseases
5. Knee joint infection
6. severe cardiopulmonary dysfunction.
A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.

This study will assess the efficacy of a 12-week treatment with darifenacin in increasing warning time, the time from first sensation of urgency to voiding, in patients with OAB.


Eligibility Criteria:
Inclusion Criteria:

* Three symptoms of OAB (urge incontinence, frequency and urgency) for at least six months prior to Visit 2.
* Patients capable of independent toileting and able of independently completing the patient diary.

Exclusion Criteria:

* Patients in whom the use of anticholinergic drugs was contraindicated
* Evidence of severe liver disease
* Patients with other clinically significant urinary or gynecological conditions

Other protocol-defined inclusion/exclusion criteria may apply.