cyrilzakka/clinical-trials huggingface dataset:
Antineoplaston Therapy in Treating Patients With Recurrent or Stage IV Lung Cancer

Current therapies for Recurrent or Stage IV Lung Cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Recurrent or Stage IV Lung Cancer.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Recurrent or Stage IV Lung Cancer.

Recurrent or Stage IV Lung Cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with Recurrent or Stage IV Lung Cancer, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in patients with Recurrent or Stage IV Lung Cancer.
* To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed recurrent or stage IV bronchoalveolar cell lung cancer unlikely to have a curative response to existing standard regimens
* Measurable disease by MRI or CT scan

  * At least 2 cm in diameter

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* At least 2 months

Hematopoietic:

* WBC at least 2,000/mm\^3
* Platelet count at least 50,000/mm\^3

Hepatic:

* Bilirubin no greater than 2.5 mg/dL
* SGOT/SGPT no greater than 5 times upper limit of normal
* No hepatic failure

Renal:

* Creatinine no greater than 2.5 mg/dL
* No renal insufficiency
* No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

* No severe heart disease
* No uncontrolled hypertension
* No history of congestive heart failure
* No history of other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

* No severe lung disease (e.g., chronic obstructive pulmonary disease)

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 4 weeks after study participation
* No serious active infections
* No other concurrent serious disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior immunotherapy and recovered
* No concurrent immunomodulating agents

Chemotherapy:

* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
* No concurrent antineoplastic agents

Endocrine therapy:

* Concurrent corticosteroids allowed

Radiotherapy:

* At least 8 weeks since prior radiotherapy and recovered

Surgery:

* Recovered from prior surgery

Other:

* No prior antineoplaston therapy
* Prior cytodifferentiating agent allowed
Evaluation of the Role of Prostaglandins in Radiation-induced Mucositis

This study will evaluate the role of cyclooxygenase pathways in radiation-induced and chemoradiation-induced mucositis.

Oral mucositis is a significant toxicity of radiation therapy and chemoradiation therapy in head and neck cancer patients. However the mechanisms that induce such mucositis are not completely understood. Previous work evaluating mucositis in bone marrow transplant patients has suggested that prostaglandin levels may be associated with the appearance of mucositis.

The present study will measure the levels in saliva of the prostaglandins PGE2 and PGI2 before, during, immediately after, and several weeks after radiotherapy for head and neck cancer. These salivary levels will be correlated with clinical observation of mucositis and patient reporting of pain levels.

Improved understanding of the mechanism of mucositis may lead to the development of more effective targeted agents to prevent this problem.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven locoregional Stage 4 squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx
* Receiving radiation therapy or chemoradiation therapy to the oropharynx
* Older than 18 years old
* ECOG performance status of 0-2
* Life expectancy greater than 2 months
* Signed informed consent

Exclusion Criteria:

* Previous chemotherapy for this malignancy
* Previous radiotherapy to the head and neck
* Other cancer diagnosis within the last 5 years except for non-melanoma skin cancer or non-metastatic prostate cancer
* Patient taking NSAIDs
A Phase I Study of TS-142 in Healthy Participants (Single Doses)

The purpose of this study is to investigate the safety and pharmacokinetics of single dosing of TS-142 to healthy Japanese non-elderly participants in fasting and after meal condition.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥18.5 and \<25.0 kg/m\^2 at screening inspection

Exclusion Criteria:

* History of clinically relevant disease of some organ systems that may be considerd inappropriately for this study
* History of drug and food allergy
Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction

the investigators purpose is to predict hypotensive condition that can develop after general anesthesia induction by measuring the Tricuspid Annular Plane Systolic Movement (TAPSE), which is an echocardiographic parameter.

Intraoperative hypotension development might increase myocardial damage, acute kidney damage, and septic complications, and have an effect on mortality increase. For this reason, prevention of an unwanted hypotensive event has an important role in reducing mortality and morbidity. The prediction of the risk of hypotension is generally based on the evaluation of the comorbid status and volume status of patients .It is already known that right ventricular systolic dysfunction has prognostic value in various pathological cases. It is quite difficult to evaluate the RV function with echocardiography because of the complex geometry of RV. Although RV function has been evaluated only visually for many years, guidelines have been published as a result of recent studies by the American Society of Echocardiography. In this respect, abnormal RV function should be suspected when one of the criteria of S '\<10 cm /s, TAPSE \<16 mm, RVFAC \<35%, or R-MPI (Tissue Doppler)\> 0.55. Normal and abnormal function is distinguished more reliably when combining more than one RV function measures. TAPSE is a parameter with which the apex-basal shortening can be easily measured, providing specific data on global RV function. It depends less on optimal image quality than other RV function measurements, and is an easy-to-measure criterion. Low TAPSE is not very common; however, it was measured in people with no heart disease due to diagnostic misclassification and excessive ends of the normal spectrum. the investigators think that despite the lack of cardiac disease, cardiac reserve functions of each patient may have limits in terms of development of hypotension in general anesthesia induction. The investigators considered that TAPSE, which decreased within normal limits in patients without cardiac disease, could predict hypotension development in general anesthesia induction, and planned study for this purpose.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective surgery
* Patients who will receive general anesthesia
* Patients between 18-65 years of age
* Physical status I or II according to the American Society of Anesthetists (ASA) in preoperative evaluation
* Those without known heart disease
* Patients with TAPSE value above 1.6 cm

Exclusion Criteria:

* Patients under the age of 8 and over 65,
* Pregnant patients,
* Patients who refuse to participate in the study,
* ASA III and above,
* Patients with known heart disease,
* Patients with TAPSE value of less than 1.6 measured with Transthoracic Echocardiography will not be allowed to be included in the study.
* Patients with difficult airway management or difficult intubation will be excluded from the study.
A Study of Sublingually Administered (S)-Ketamine Oral Solution in Healthy Participants

The purpose of this study is to characterize the plasma pharmacokinetic (PK) profile following the single ascending dose (SAD) levels of an (S)-ketamine oral solution for sublingual administration in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 20.0 and 28.0 kilogram per meter square kg/m\^2 inclusive (BMI = weight/height\^2) with a minimum weight of 60 kilogram (kg) and a maximum of 100 kg
* Participant must be healthy based on clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology or urinalysis are outside the normal reference ranges, retesting of an abnormal lab value that may lead to exclusion will be allowed once during the screening phase
* Non-smoker (not smoked for 3 months prior to screening)
* A woman must have a negative serum beta-human chorionic gonadotropin (beta-hCG) at screening and a negative urine pregnancy test prior to dosing on Day 1
* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 1 month after the last study drug administration

Exclusion Criteria:

* Cardiac arrhythmias or other cardiac disease, hematological disease, hypertension, lipid abnormalities, respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, glaucoma, epilepsy or any other illness that the Investigator considers should exclude the participant
* Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies at screening visit
* Drinks, on average, more than 5 cups of tea/coffee/cocoa or 8 cans of cola per day
* Clinically significant acute illness within 7 days prior to study drug administration
* Donation of 1 or more units (approximately 450 milliliter \[mL\]) of blood or acute loss of an equivalent amount of blood within 90 days prior to study drug administration
PORTHOS - PORTuguese Heart Failure Observational Study

This study aims to determine the prevalence of heart failure in the resident population in mainland Portugal aged 50 years or above, using a contemporary, guideline-based diagnostic approach, to optimize patient management and improve strategic healthcare decision-making

The contemporary prevalence of heart failure in Portugal is largely unknown and may differ from that reported in early studies, which were conducted in the late 1990s-early 2000s with the diagnostic techniques available at the time and did not include neither advanced echocardiographic parameters nor natriuretic peptides measurements. Thus, a large and representative study is needed to address knowledge gaps on the epidemiology, characteristics and burden of heart failure in Portugal. The study aims to determine the prevalence of global heart failure, as well as heart failure subtypes. It also aims to assess the distribution of comorbidities among patients with heart failure, as well as patients' health-related quality of life. The Investigators will conduct a population-based study with a three-stage design approach, enrolling 5616 subjects aged 50 years or above, randomly selected through multi-stage sampling, using the National Health Service as reference: PHASE 0 - Participant selection/enrollment through phone call; PHASE 1 - Screening (NT-proBNP levels determination), health-related quality of life evaluation and sociodemographic characterization; PHASE 2 - Confirmatory assessment with a 12-lead electrocardiography, comprehensive transthoracic echocardiography, extended symptoms assessment and biomarkers assessment; PHASE 3 - Heart failure with preserved ejection fraction exertion testing through a non-invasive echocardiographic diastolic stress test.

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling citizens living in Mainland Portugal;
* Registration in a primary care centre;
* Age ≥50 years at recruitment;
* Voluntary signed informed consent.

Exclusion criteria:

* Living in institutions (e.g., nursing homes, prisons, military facilities, hospitals);
* Non-Portuguese speakers;
* Reduced physical and/or cognitive ability hampering participation (e.g., blindness, deafness, or cognitive impairment).
Finding Opportunities for Clinical Care and Trial Participation Among Underrepresented Samples

Focus groups for Hispanic women who are pregnant and their close family members to assess attitudes, barriers and cultural beliefs involved in participation in clinical trials

This is a qualitative study conducted with Hispanic pregnant women and their families. Focus groups for Hispanic pregnant women will run concurrent to groups for their close family member, but in separate rooms. Each focus group session of approximately 8-10 participants is expected to last 60-90 minutes and will be led by an experienced moderator who is fluent in Spanish. All discussions will be audio taped and will be kept confidential. Information learned will be used to refine clinical trial procedures and ensure our model of recruitment and retention in the parent ADORE Trial (NCT02626299) is culturally and linguistically acceptable and feasible.

Eligibility Criteria:
Inclusion Criteria:

* Hispanic women between the ages of 18.0-49.99 yrs old who have been pregnant within the past 5 years OR a close family member
* Speak and understand Spanish

Exclusion Criteria:

-
Dual Triggering in Patients With a High Immature Oocyte Rate

In in vitro fertilization (IVF) cycles, even after adequate triggering, some patients present a high rate of immature oocytes retrieved after controlled ovarian stimulation. In vitro oocyte maturation is still an experimental technique, with poorer results than conventional IVF. For that reason improve in in vivo maturation could have a better impact on reproductive outcome.

Investigators performed an observational study analyzing the difference in the percentage of mature oocytes retrieved in patients with more than 50% immature oocytes in a previous IVF cycle triggered with human chorionic gonadotropin (rhCG) compared to the rate of mature oocytes retrieved in subsequent cycles, triggered with both gonadotropin-releasing hormone agonist (GnRHa) and (hCG). The main outcome measure was the number and percentage of mature oocytes retrieved.

Eligibility Criteria:
Inclusion Criteria:

* BMI of 18-30 kg/m2
* Male factor required for ICSI

Exclusion Criteria:

-
The Basophil Activation Test For Egg Allergy

In this study, basophil activation test (BAT) established by the investigators' lab was evaluated for its sensitivity and specificity in child egg allergy diagnosis. Children with suspected IgE mediated allergy to egg will be recruited in the study. Specific IgE to egg allergen and BAT will be detected. The diagnostic accuracy of the BAT will be assessed against clinical diagnosis based on history, clinical symptoms and laboratory results.

In china, the prevalence of food allergy in in preschool children was about 7%. Diagnosis of food allergy is mainly based on a combination of clinical history, clinical manifestations and related supplementary examinations, including skin prick testing (SPT), serum specific IgE testing (sIgE), and oral food challenge (OFC). Although OFC is the gold standard for allergy diagnosis, it is rarely conducted in clinic for the low safety. Until now, serum specific IgE assays against allergen are the most commonly used in vitro diagnostic approach in China. However, specific-IgEs are sensitive, but not specific for diagnosis of food allergy. Moreover, food allergy could not be excluded when sIgE results are negative (\<0.35KU/L). Thus, more accurate and safer test is needed. BAT was shown to have good accuracy for food allergy diagnosis. BAT is an ex vivo functional assay that measures by flow cytometry the degree of basophil activation after stimulation with an allergen. However, experimental strategies for BAT reported in the literatures are different. Some research even used 12 kinds of antibodies to identity basophils. In previous study, the investigators established BAT using 4 kinds of antibodies. Basophils could be distinguished well from other cells. In this study, children aged 4 months to 6 years who visit pediatric and emergency department, and are suspected with egg allergy will be included in study. Detailed information about clinical history and manifestations will be collected. Serum sIgE to food and BAT will be detected. The proposed study intends to analyze sensitivity and specificity of the established BAT according to the clinical comprehensive diagnosis results, and evaluate its efficacy to diagnose food allergy in children.

Eligibility Criteria:
* 1.Children older than 4 months and younger than 6 years old
* 2.Suspected egg allergy with one or more of the following complaints after intake of egg: Skin or mucous symptoms (e. g. urticaria, increased eczema, or swollen lips) Respiratory symptoms (tight throat or shortness of breath with signs of bronchial obstruction) loss of consciousness Gastrointestinal symptoms (nausea, vomiting, abdominal pain, diarrhea) Ocular symptoms (conjunctival erythema, pruritus, tears) and other related symptoms
* 3. Sign informed consent by parents/guardians

Exclusion Criteria:

* 1.Patients with hematological tumors, autoimmune diseases, organ transplantation, and immunodeficiency diseases
* 2.Take immunosuppressants, immunomodulators, statins, and inject anesthetics within 3 weeks
Intravitreal Adalimumab in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration

Adalimumab is a humanized recombinant monoclonal antibody fragment targeted against tumor necrosis factor. This study will assess the safety and efficacy of intravitreal adalimumab administered in patients with choroidal neovascularization secondary to age-related macular degeneration non-responders to the conventional treatment with intravitreal ranibizumab.


Eligibility Criteria:
Inclusion Criteria:

- Choroidal neovascularization secondary to age-related macular degeneration non-responders to the conventional treatment with ranibizumab (active choroidal neovascularization after loading phase of one injection per month for three consecutive months, followed by a maintenance phase with 5 injections in the last 12 months or 3 injections in the last 6 months

Exclusion Criteria:

* Only one functional eye
* Hypersensitivity to adalimumab or any component of the formulation
* Previous systemic treatment with adalimumab
* Cancer
* Life expectancy \<1 year
Aneuploidies and Different Stimulation Protocols

Our working hypothesis is that patients undergoing "in vitro" fertilization (IVF) with higher response to ovarian stimulation protocols recover a higher number of oocytes and, this elevated response could be translated into increased incidence of chromosomally abnormal embryos. Our objective is to develop a prospective study on healthy young donors, with a previous cycle with high ovarian response (\>20 oocytes and/or E2 levels the day of the hCG injection \>3000 pg/mL), but without developing mild or severe hyperstimulation syndrome. After signing a proper written consent, these donors would agree to undergo two subsequent stimulation cycles following two different protocols. In one cycle the stimulation pattern would be similar to the previous one, with elevated response and, in another cycle the amount of gonadotropins would be cut down in order to obtain lower ovarian response. Oocytes obtained in each cycle would be donated to anonymous recipients and after fertilization, embryo quality and chromosomal status of the resulting embryos would be evaluated. Preimplantation genetic diagnosis (PGD) will be performed on day-3 embryos and chromosomes 13, 15, 16, 17, 18, 21, 22, X and Y would be analyzed by fluorescence "in situ" hybridization (FISH).


Eligibility Criteria:
Inclusion Criteria:

* Healthy women between 18 - 29
* with previous cycle with standard dosis of Gonadotrophin and high response to the treatment (\> 20 oocytes)
* No symptom of OHSS

Exclusion Criteria:

* donors with 2 previous miscarriages
* PCO
* Severe Male Factor
Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event

To explore two modalities of treatment initiation (Pre-discharge, and Post-discharge) with LCZ696 in HFrEF patients following stabilization after an ADHF episode.


Eligibility Criteria:
Inclusion Criteria:

1. Patients hospitalized due to acute decompensated HF episode (ADHF) as primary diagnosis) and consistent Signs \& Symptoms
2. Diagnosis of HF New York Heart Association class II-to-IV and reduced ejection fraction: Left ventricular ejection fraction ≤ 40% at Screening
3. Patients did not receive any IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for ADHF to Randomization
4. Stabilized (while in the hospital) for at least 24 hours leading to Randomization.
5. Meeting one of the following criteria:

   * Patients on any dose of ACEI or ARB at screening
   * ACEI/ARB naïve patients and patients not on ACEI or ARB for at least 4 weeks before screening.

Exclusion Criteria:

1. History of hypersensitivity to the sacubitril, valsartan, or any ARBs, NEP inhibitors or to any of the LCZ696 excipients.
2. Symptomatic hypotension and/or a SBP below 110 mm Hg or SBP above 180 mm Hg prior to randomization
3. End stage renal disease at Screening; or estimated GFR below 30 mL/min/1.73 m2 (as measured by MDRD formula at Randomization.
4. Serum potassium above 5.4 mmol/L at Randomization.
5. Known history of hereditary or idiopathic angioedema or angioedema related to previous ACE inhibitor or ARB therapy
6. Severe hepatic impairment, biliary cirrhosis and cholestasis