cyrilzakka/clinical-trials huggingface dataset:
Study of the Immunity of Patients With Lung Cancer and COVID-19 Infection

Observational, retrospective data collection and prospective IgG analysis, and multicenter study.

The main objective of the study is th description of the characteristics and evolution of patients with lung cancer who have acquired COVID-19 infection.

For the identification of patients who contract COVID-19 infection, the IgG+ blood test by ELISA method will be used.

Non-post-authorization study, retrospective of data collection and prospective of IgG analysis, observational and multicenter.

The study will be extended to all the sites of the Spanish Lung Cancer Group, more than 170 centers and 500 professionals, and it is expected that around 1,500 IgG tests will be carried out.

The study has three phases:

The scope of phase I is the identification of acquired immunity (IgG) in patients with lung cancer, whether or not they have presented symptoms of having suffered from COVID19. In addition, the description of the characteristics and evolution of patients with lung cancer who have contracted COVID-19 infection will be carried out.

For the identification of patients who contract COVID-19 infection, the IgG+ test in blood will be used by ELISA method.

The scope of phase II is the confirmation of the presence of antibodies (IgG) in patients who tested positive in Phase I of the study a few weeks after the first diagnosis made through the SOLID study.

The scope of phase III is the confirmation of the presence of antibodies (IgG) in patients with lung cancer who have been vaccinated with any of the available and authorized vaccines for SARS-COV2 and 6 months after said administration.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with lung cancer at any stage of the disease
2. Age ≥ 18
3. Patients who have signed the informed consent for this study

Exclusion Criteria:

1. Patients who have not signed or do not wish to sign the informed consent for this study
Efficacy of Genicular Nerve Radiofrequency

In patients with knee pain, local anesthetics and radiofrequency applications to superolateral, superomedial and inferomedial genicular nerves that innervate the knee joint are also preferred methods besides analgesic and physical therapy. When necessary, total knee replacement is the preferred method for primary knee arthrosis.

However, continuing knee pain is reported in approximately 20% of patients after total knee replacement. In similar cases; In the painful knees, the blockages of the genicular nerves are successfully applied.

In this study; the efficacy of imaging-guided radiofrequency application will be investigated in patients presenting with knee pain after total knee replacement.

Although simple analgesic and physical therapy methods are applied, some patients suffer from pain. Genicular nerve blocks and radiofrequency methods are performed usually for this reason. This procedure is performed with ultrasound and / or fluoroscopy, sterile staining and covering of painful knee to the middle of thigh and leg, localization of superomedial, superolateral, inferomedial genicular nerves are tested and then conventional radiofrequency is applied to all 3 nerve regions.Fifty patients who had total knee prosthesis for gonarthrosis in the Orthopedics and Traumatology Clinic at least 3 months postoperatively had knee pain (infection, mechanical causes and radicular pain) were included in the study.The VAS and WOMAC values recorded at the time of application and the VAS and WOMAC values recorded at the 1st week, 1st month and 3rd month after the procedure will be used to evaluate the effectiveness of the method.

Eligibility Criteria:
Inclusion Criteria:

* knee pain

Exclusion Criteria:

* with communication problems (VAS and WOMAC scores could not be evaluated)
* infectious-mechanical pain-related conditions,
* with radicular pain
Optimizing the Social Engagement System in Prader-Willi Syndrome: Insights From the Polyvagal Theory

The Polyvagal Theory focuses on how function and structure changed in the vertebrate autonomic nervous system during evolution. The theory is named for the vagus, a major cranial nerve that regulates bodily state. As a function of evolution, humans and other mammals have a "new" vagal pathway that links the regulation of bodily state to the control of the muscles of the face and head including the middle ear muscles. These pathways regulating body state, facial gesture, listening (i.e., middle ear muscles), and vocal communication collectively function as a Social Engagement System (SES). Because the Social Engagement System is an integrated system, interventions influencing one component of this system (e.g., middle ear muscles) may impact on the other components.

Individuals with Prader-Willi Syndrome (PWS) exhibit many behaviors that are consistent with a compromised Social Engagement System. Atypical function of the Social Engagement System results in problems associated with state regulation (e.g., impulsivity, tantrums, and difficulty with change in routine), ingestion (e.g., difficulties in sucking at birth, hyperphagia), coordination of suck/swallow/breathe, intonation of vocalizations, auditory processing and hypersensitivity, and socialization. We propose to confirm that several features of the behavioral phenotype of PWS may be explained within the context of a dysfunctional SES (Specific Aim I), which may be partially rehabilitated via an intervention designed as a 'neural exercise' of the SES (Specific Aim II).

Specific Aims:

Aim I: To demonstrate that children with PWS have atypical regulation of the SES. We hypothesize these effects will be manifested by dampened vagal regulation of the heart (low parasympathetic tone); poor middle ear muscle regulation resulting in auditory hypersensitivities and poor auditory processing; lack of voice intonation (prosody), and difficulties in accurately detecting the emotions of others.

Aim II: To demonstrate the effectiveness of the Listening Project Protocol (LPP) in decreasing the atypical features of the SES in adolescents with PWS. We hypothesize that individuals who complete the LPP will have improved vagal regulation of the heart, improved middle ear muscle regulation, increased voice intonation and improved ability to accurately detect the emotions of others.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must be current residents at Latham Centers (LC) School in Brewster MA
2. Participants must meet criteria for Prader-Willi Syndrome
3. Participants must be between ages 13 - 25 years
4. Participants must have normal hearing
5. Participants must have normal vision (or corrected vision)

Exclusion Criteria:

1. Individuals with current (or a history of) heart disease
2. Individuals who are hearing-impaired
3. Individuals who are being treated for seizure disorder
4. Individuals who do not read/speak English
5. Individuals who are sight-impaired without correction
Laser Therapy Following Radiotherapy for Gynecological Cancer

Women with a history of pelvic radiotherapy due to gynecological cancer, will receive laser therapy for the management of genitourinary syndrome of menopause.


Eligibility Criteria:
Inclusion Criteria:

* History of gynecological cancer treated with pelvic radiotherapy
* last radiotherapy \>1 year
* women sexually active or willing to resume sexual activity
* symptoms of dyspareunia, vaginal dryness, itching/burning and vaginal bleeding related to sexual intercourse

Exclusion Criteria:

* Relapse of gynecological cancer
* prolapse stage \>1
* active genital infection (i.e herpes, vaginitis)
* underlying pathologies that could interfere with patients compliance to the protocol (i.e any psychiatric condition)
A Study of the Immune Response to Heplisav in Healthy Older Adults

This study will investigate the response of the immune system to a hepatitis B (HB) vaccine in healthy adults 50 to 70 years of age. This study is partially funded by the National Institute of Allergy and Infectious Diseases.

The purpose of this study is to examine how the immune system responds to vaccination with HEPLISAV.

Eligibility Criteria:
Inclusion Criteria:

* 50 to 70 years of age, inclusive
* In good health in the opinion of the principal investigator, based upon medical history and physical examination
* Serum negative for HBsAg, anti-HBs, antibody to hepatitis B core antigen (anti-HBc), hepatitis C virus (HCV), and human immunodeficiency virus (HIV)
* If female of childbearing potential, agree to consistently use a highly effective method of birth control from the screening visit through Week 12/Visit 10

Exclusion Criteria:

* Pregnant, breastfeeding, or planning a pregnancy
* Known history of an autoimmune disease
* Previously received any hepatitis B vaccine (approved or investigational)
* Body-mass index (BMI) \>30 kg/m2, diabetes mellitus (type 1 or 2), or other chronic medical condition that in the opinion of the principal investigator might interfere with the immune response to hepatitis B vaccination
Check of Optical Features and Accuracy of the Zeiss ZO Lens After Selection and Calculation With OKULIX

It is planned to implant the intraocular lenses XL Stabi ZO and Invent ZO into the eyes of patients for whom a cataract operation is medically indicated. The lenses are marketed and CE certified. Their implantation is clinical routine.

In the trial the accuracy of prediction of target refraction and the difference between calculated and measured contrast vision will be examined for both lens types.


Eligibility Criteria:
Inclusion Criteria:

* Indication for cataract operation
* Written informed consent of patient after information

Exclusion Criteria:

* Immobility
* Limited capacity of understanding
* Diseases that hamper a follow-up examination
* Astigmatism \>2.0 D
* Patients with ocular diseases who may be expected to show a vision of less than 0.63 (decimal) two months after cataract surgery with implantation of intraocular lens
* Complications during surgery, especially complications with positioning of the intraocular lens and with capsulorhexis
Insulin Modulation of fMRI Connectivity in Healthy Adults

This study evaluates the effects of changing insulin levels on brain activity. Participants will complete functional magnetic resonance imaging (fMRI) scans during fasting conditions, then during an insulin infusion.

Insulin is a hormone released by the pancreas in response to increases in glucose levels that result from food intake. In addition to stimulating glucose uptake in the periphery, insulin signals the central nervous system to induce satiety and inhibit feeding behavior.

To begin to identify the specific effects of circulating insulin on brain networks, the current study will recruit healthy participants who will undergo two functional magnetic resonance imaging scans. One scan will be performed in the fasted state, and the alternate scan will be conducted during an isoglycemic hyperinsulinemic clamp.

This project will allow us to identify the specific effects of circulating insulin on brain reactivity to palatable food.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18 and 24
* HOMA-IR \< 1.55 (homeostatic model assessment of insulin resistance - ((glucose x insulin) / 405)).

Exclusion Criteria:

* Current or lifetime history of any cardiovascular disease or surgery (including hypertension, stroke, myocardial infarction, congestive heart failure, atrial or ventricular arrhythmias, coronary bypass, carotid artery, or peripheral vascular surgery)
* Current or lifetime history of cancer, a chronic kidney or liver condition, type I or II diabetes, or any pulmonary or respiratory disease
* Current or lifetime diagnoses of any substance abuse
* Positive urine drug screen
* Current or lifetime use of glucocorticoid medications for \>1 month
* A previous cerebrovascular accident or trauma involving loss of consciousness
* Previous neurosurgery or history of a neurological condition
* Pregnancy (females)
* Claustrophobia
* Ferrous metallic implants or any surgically placed medical device not cleared for safety at 3Tesla MRI strength
* Peripheral vascular disease
* Liver, kidney, or active blood disease
* Peripheral neuropathy
* Anemia (hematocrit \<34%)
* Inability and/or willingness to comply with the protocol as written
* Fasting glucose \> 126 mg/dL
* Currently taking blood thinners such as coumadin, Lovenox, etc.
* Currently taking any medications that can alter glucose homeostasis (steroids, glucocorticoids, nicotinic acid)
* Current use of any psychotropic medications (SSRI, SNRI, etc.)
* Currently taking thiazolidinediones or insulin
* Currently use of statins or anti-hypertensive medications
* Use of medications related to HIV that can affect insulin sensitivity. We will NOT specifically test for HIV serostatus.
* Females currently on hormone replacement therapy (HRT) less than 6 months
* Participants will be instructed to abstain from eating, drinking (other than water), smoking and exercise for the 12 hours prior to each study visit.
* Being left handed
* Body mass index above 24 or below 18
* Milk allergy / lactose intolerance
* Polycystic ovary syndrome
Rapamycin Treatment for Activated Phosphoinositide 3-Kinase δ Syndrome

The purpose of this proposed research is to evaluate the efficacy and safety of the rapamycin therapy in patients with activated phosphoinositide 3-kinase δ syndrome (APDS).

Activated phosphoinositide 3-kinase δ syndrome (APDS) is a recently described autosomal dominant primary immunodeficiency (PID), caused by the mutations in PIK3CD gene. The manifestations of APDS mainly include recurrent respiratory tract infections, persistent Epstein-Barr virus (EBV)/ cytomegalovirus (CMV)infections, lymphadenopathy, splenomegaly, CD4+T cells lymphopenia, and hyper-IgM syndrome. PIK3CD encodes p110δ, the catalytic subunit of phosphatidylinositol 3-kinase (PI3K) which mainly expresses in leukocytes, being critical for their proliferation, activation and survival. Gain-of-function (GOF) PIK3CD mutations lead to PI3Kδ hyperactivity, with the downstream mediators Akt and mammilian target of rapamycin (mTOR) hyperphosphorylated. Patient-derived lymphocytes had increased levels of phosphatidylinositol 3,4,5-trisphosphate and phosphorylated AKT protein. Hyperactivation of mTOR increases phosphorylation of kinases and increased glycolysis that results in enhanced proliferation and senescence of terminally differentiated CD8+ Tcell populations.

The optimal treatment for these APDS patients is not yet determined; however, there are many kinds of therapeutic approaches (anti-infection prophylaxis, immunoglobulin replacement, conventional immunosuppressants, PI3K/mTOR inhibitors and hematopoietic stem cell transplantation). The APDS patients frequently receive treatment with immunoglobulin replacement and antibiotics. Hematopoietic stem cell transplantation (HSCT) has been currently curative in APDS patients; however, longer-term follow-up to determine the degree of donor chimerism and efficacy is required. There are several subjects without a prompt suitable matched donor or for whom the critical disease conditions force to postpone HSCT.The mammalian/mechanistic target of inhibitor rapamycin was reported to improve circulating T-cell profiles. Individual patients in previous studies experienced a decrease in nonneoplastic lymphoproliferation while taking rapamycin.

The investigators in this study hope to evaluate the efficacy and safety of rapamycin in the treatment for carefully selected patients with APDS.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with activated phosphoinositide 3-kinase δ syndrome
2. No more than 18 years old

Exclusion Criteria:

1. Patients with serious fungous infection
2. Patients with serious complications
3. Lack of parental consent
ESOS (Endoscopic Saphenous Harvesting With an Open CO2 System) Trial

The ESOS (Endoscopic Saphenous harvesting with an Open CO2 System) trial is a prospective randomized trial for coronary artery bypass grafting (CABG) surgery to compare endoscopic open CO2 harvesting system versus conventional vein harvesting.

The ESOS (Endoscopic Saphenous harvesting with an Open CO2 System) trial is a prospective randomized trial for coronary artery bypass grafting (CABG) surgery to compare and to test improvement in wound healing, quality of life, safety/efficacy, cost-effectiveness, short and long-term outcomes and vein-graft patency after endoscopic open CO2 harvesting system versus conventional vein harvesting.

Eligibility Criteria:
Inclusion Criteria:

* Elective planned CABG surgery
* First isolated CABG surgery

Exclusion Criteria:

* Emergency revascularization: patients with hemodynamic instability or requiring inotropic or intra-aortic balloon support
* Previous cardiac surgery
* Planned concomitant valve surgery
* Very varicous veins
* Previous saphenectomy
* History of deep vein thrombosis
* History of suffered trauma on the lower extremity
* Preoperative legs immobilization
* Previous leg wound complications
* Coexisting illness with life expectancy \< five years
Mg Wire for Augmentation of ACL Reconstruction

Background: ACLR with autologous tendon graft is commonly used for the treatment of ACL injury. However, as the BTI healing is poor, this can lead to a failure rate of 5% in the first-year post-operation; a long and unpredictable rehabilitation period is expected and 35 % of patients never return to preinjury level of sports. Biological enhancement of BTI healing will help to cut down the medical cost related to poor prognosis. As a biodegradable metal, Mg has been developed as implants in orthopaedics for decades, yet without clinical implants developed for ACLR. Our team has been working on this area in the past 10 years preclinically. Our animal studies showed that supplementation of magnesium wire significantly promotes osteogenesis at BTI and improves mechanical strength in ACLR. Recently, our team developed a highly pure (99.99%) Mg wire (Fig 2) in collaboration with metallic engineers for tendon graft braiding during ACLR and with its improved physical quality and strength, it is suitable for graft braiding and then its degradation in vivo can promote tunnel bone formation and bone tendon interface integration.

Objective: To investigate if anterior cruciate ligament (ACL) reconstruction augmented with magnesium (Mg) wire enhances osteogenesis at the bone-tendon interface (BTI), improving post-op rehabilitation and leading to better clinical outcomes.

Hypothesis: Patients with ACL reconstruction using Mg wire will experience improved osteogenesis at the BTI, more effective rehabilitation, and superior knee strength and function.

Design and Subjects: A multicentre, double-blinded, randomized controlled trial will recruit patients aged 18-30 with unilateral ACL tear for primary ACLR with a hamstring graft at four sites.

Instruments: Mg-based wire.

Interventions: Participants will receive either 99.99% purity Mg wire or 2-0 vicryl as a control.

Main Outcomes: Osteogenesis will be assessed by High-Resolution Peripheral Quantitative Computed Tomography (HR-pQCT), muscle strength via Biodex tests, and functional recovery with International Knee Documentation Committee (IKDC) and Tegner scores at multiple post-op intervals. Knee stability will be checked with KT-1000 arthrometer. Blood samples will be analyzed for inflammatory markers and metabolic effects related to Mg wire.

Data Analysis and Expected Results: A repeated-measures ANOVA will be utilized for data analysis. The expectation is that Mg wire augmentation will significantly enhance osteogenesis at the BTI and improve rehabilitation outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-40
* Unilateral ACL tear for primary ACLR (Single bundle, Hamstring) confirmed clinically and radiologically.

Exclusion Criteria:

* Concomitant multiple ligament injuries requiring additional surgical procedures,
* Preoperative radiographic signs of arthritis,
* Revision ACLR
* Femoral tunnel interference screws
* Contralateral knee with ACL deficiency or reconstruction
* Medical co-morbidities
* Long-term steroid intake
* Non-compliance to our rehabilitation protocol.
A Trial to Evaluate the Effect of C21 on Endothelial Dysfunction in Subjects With Type 2 Diabetes

This trial is a single-centre, randomized, double-blind, placebo-controlled, 2-way cross-over phase 1b trial evaluating the pharmacodynamic effect of C21 on endothelial dysfunction and safety in subjects with type 2 diabetes mellitus (T2DM).


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient aged ≥ 40 years at the time of the screening visit (Visit 1).
* Documented diagnosed with T2DM prior to the screening visit (Visit 1).
* An RHI score ≤ 2 as assessed by EndoPAT at the time of the screening visit (Visit 1).

Exclusion Criteria:

* Known, active hepatitis B, C, or human immunodeficiency virus (HIV) infection (i.e., HIV with a CD4 (cluster of differentiation 4) count \<500 cells/mm³).
* Impaired hepatic function or clinically significant liver disease, which in the investigator's opinion makes the subject inappropriate for this trial.
* Severe renal impairment (i.e., estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m2).
* Prolonged QTcF (QT interval with Fridericia's correction) (\>450 ms), atrial fibrillation, clinically significant arrhythmia or other clinically significant abnormality in the resting ECG (electrocardiogram) at screening (Visit 1), as judged by the investigator.
* Unstable or deteriorating cardiac condition.
* Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I.
Thermosensitive Gels for the Vaginal Delivery of Sildenafil Citrate

The aim of this study was to develop and characterize in situ thermosensitive gels for the vaginal administration of sildenafil as a potential treatment of the endometrial thinning that occurs as a result of the use of clomiphene citrate in induction of ovulation in women with World Health Organization type II EU gonadotrophic anovulation.


Eligibility Criteria:
Inclusion Criteria:

* women with polycystic ovaries

Exclusion Criteria:

* women with other causes of infertility