cyrilzakka/clinical-trials huggingface dataset:
Monoclonal Antibody Therapy in Treating Patients With Advanced Kidney Cancer

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them.

PURPOSE: Randomized phase II trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have advanced kidney cancer that cannot be surgically removed.

OBJECTIVES: I. Determine the effect of monoclonal antibody VEGF on time to progression, angiogenesis, and overall survival in patients with unresectable advanced renal cell cancer.

II. Evaluate serum antibody levels and biologically active vascular endothelial growth factor levels in the plasma of patients treated with this regimen.

III. Evaluate the toxicity of this regimen in these patients.

PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by prior interleukin-2 therapy (yes vs no).

Patients are randomized to receive either placebo or one of two doses of monoclonal antibody VEGF. Following an initial loading dose, patients receive one dose of the study drug intravenously every 2 weeks for up to 2 years in the absence of disease progression. Patients who are given placebo and experience disease progression are offered monoclonal antibody VEGF and thalidomide if there are no contraindications.

PROJECTED ACCRUAL:

A total of 150 patients will be accrued for this study over 2 years.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Histologically proven unresectable advanced renal cell cancer Measurable disease Must have received or not be a suitable candidate for interleukin-2 therapy No papillary or collecting duct renal cell cancer No CNS metastases --Prior/Concurrent Therapy-- Biologic therapy: See Disease Characteristics No prior thalidomide At least 4 weeks since other prior biologic therapy No other concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior endocrine therapy No concurrent corticosteroid therapy Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: WBC at least 1,000/mm3 Platelet count at least 75,000/mm3 No coagulation disorder, active bleeding, or wound healing problem Hepatic: Total bilirubin no greater than 2.0 mg/dL (for patients with Gilbert's disease, direct bilirubin less than 0.5 mg/dL) SGOT or SGPT no greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No coronary artery disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No clinically evident preexisting peripheral neuropathy
Myo-inositol Versus Metformin in Obese Women With Polycystic Ovary Syndrome

The aim of this study is to compare the effects of six months treatment of two insulin-lowering therapies on the clinical and endocrine-metabolic parameters in obese women affected by polycystic ovary syndrome. The study group includes 40 patients, randomly allocated to subgroup A (metformin 1500 mg/day) and subgroup B (myo-inositol 1500 mg/day). The investigations include menstrual pattern and hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycemic hyperinsulinaemic clamp and lipid profile at baseline and after six months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* women with Polycystic Ovary Syndrome, diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003;
* BMI\>25 kg/m2;
* age 18-35 years.

Exclusion Criteria:

* pregnancy;
* significant liver or renal impairment;
* other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs);
* neoplasms;
* unstable mental illness;
* diagnosis of diabetes mellitus or impaired glucose tolerance;
* use of drugs able to interfere with gluco-insulinaemic metabolism for at least three months prior to entering the study.
Evaluation of the Dexcom G6 Continuous Glucose Monitoring System With a Non-Interferent Sensor

The objective of the study is to demonstrate effectiveness of the G6 sensor membrane, in preventing acetaminophen's interference effect on glucose sensing.

The interference effect of the sensor will be evaluated by comparing the bias in the glucose values exhibited from the G6 CGM system after administration of acetaminophen. Bias will be evaluated by comparing CGM values to a laboratory referenceusing venous sample measurements.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 or older
* Diagnosis of diabetes

Exclusion Criteria:

* Pregnancy
* Known gastroparesis
* Abnormal liver function
Peripheral Blood and/or Bone Marrow, Including Detection of Occult Metastases, in Patients With Melanoma

The purpose of this study is to determine if tumor cells can be detected in the peripheral blood and/or bone marrow of patients with melanoma.

Patients with melanoma can succumb to subclinical metastatic disease, not detectable at presentation by conventional physical examination, hematologic and biochemical screening, or radiologic evaluation. More intensive radiologic evaluation with CT or radioisotope scanning has not proven to be useful. What may be useful is a more sensitive method of staging melanoma patients at presentation, specifically evaluating them for subclinical systemic disease.

Eligibility Criteria:
Inclusion Criteria:

MSK Patients with histologically confirmed melanoma of any site and at least one of the following:

* Primary tumor \> 4.0 mm thick (AJCC Stage IIB)
* Clinically or histologically positive regional nodes (AJCC Stage III)
* Any in transit disease (AJCC Stage III)
* Any systemic metastases (AJCC Stage IV)
Exhaled Breath Particles in Lung Transplantation

Lung transplantation (LTx) is the only effective treatment for patients with end stage lung disease. Of the major organs transplanted, survival following LTx is the lowest with a mean of 5 years. Despite improvements, primary graft dysfunction (PGD) remains the leading cause of early mortality and contributes to the development of chronic lung allograft dysfunction (CLAD) that remains the leading cause of late mortality. Earlier detection of rejection after LTx is of substantial importance as it would improve the possibilities of treatment and could increase survival.

The investigators have shown in previous work that exhaled breath particles (EBP) reflect the composition of respiratory tract lining fluid (RTLF). EBP and particle flow rate (PFR) can be used as non-invasive methods for early detection and monitoring of airway diseases such as acute respiratory distress syndrome (ARDS). It has also been shown that the particle flow prolife after lung transplantation differs between patients who develop PGD and those who do not and that the composition of EBP differs between patients with and without bronchiolitis obliterans syndrome (BOS), an obstructive form of CLAD.

Samples of EBP and measurements of PFR will be collected from lung transplanted patients. Membranes with EBP will be saved for molecular analysis. The investigators aim to identify potential particle flow patterns and biomarkers for earlier detection of rejection after lung transplantation.

Samples of EBP and measurement of PFR will be done on patients undergoing lung transplantation at Skåne University Hospital (SUS) Lund. Measurements of EBP and PFR and collection of blood will be done repeatedly postoperatively when the patient is still in the hospital, at three months post-transplantation, at six months post-transplantation, at 12 months post-transplantation and annually after that. An additional preoperative blood sample will also be obtained. Furthermore, the investigators will collect bronchoalveolar lavage fluid (BALF) and lung biopsies when the patient is scheduled for routine bronchoscopies in the follow-up period.

This study involves measurements of EBP and PFR done by the particles in exhaled air (PExA) system on lung transplanted patients with and without acute or chronic rejection. The patients who do not develop any form of rejection will serve as a control group to the ones who develop rejection. Furthermore, each patient will serve as their own control.

The purpose of this study is to find better means of identifying rejection of transplanted lungs in earlier stages, and to explore candidate biomarkers. Earlier diagnosis of rejection of the transplanted organ can lead to better treatment possibilities and a positive impact on survival after LTx.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone LTx at Skåne University Hospital, SUS Lund

Exclusion Criteria:

* None
Observational Study of Conjunctivitis in the Setting of DUPIXENT® Treatment for Atopic Dermatitis

The primary objective of the study is to characterize the clinical phenotype(s) of DUPIXENT®-associated conjunctivitis events.

The secondary objectives of the study are to characterize the course of conjunctivitis events during the observation period and collect and assess data on treatment for conjunctivitis events and its effectiveness.


Eligibility Criteria:
Key Inclusion Criteria:

* Treatment with DUPIXENT® for AD (per the current US Prescribing Information) should be ongoing, and have been initiated at least 8 weeks prior to study enrollment. NOTE: A single missed dose in the 8 weeks prior to enrollment is allowed.
* Patients with protocol-specified conjunctivitis events must present with active bilateral conjunctivitis (with or without cornea or eyelid involvement) diagnosed by the ophthalmologist (investigator) which meets all of the following criteria:
* Developed (or significantly worsened) while receiving treatment with DUPIXENT® for AD
* Is clinically significant (eg, moderate-to-severe, extensive, persistent, etc) as determined by the investigator
* There is a suspected causal relationship between DUPIXENT® and conjunctivitis because:
* Conjunctivitis is a new-onset condition or an unusual worsening of a preexisting condition (eg, significantly more severe, more extensive, or more protracted than ever before) AND
* No alternative explanation is more plausible, in the opinion of the investigator
* Reference patients must have AD treated with current ongoing treatment with DUPIXENT® for equal or longer duration as compared to group 1, with no clinical signs of ocular inflammation noted during the entire DUPIXENT® treatment

Key Exclusion Criteria:

* Any known medical, social, or personal limitations that are likely to restrict the patient's ability to undergo study visits and complete study procedures (as assessed by the investigator), including hypersensitivity or other contraindications to the anesthetic eye drops used during the ophthalmological examination.

NOTE: Other protocol defined inclusion/exclusion criteria apply.
Role of Nutritional Intervention in Critically Ill Child

* Assess the nutritional status of critically ill children using different nutritional assessment tools in management.
* Assess accuracy and validity of screening tools in diagnosis of malnutrition by the following:

  * Strong kids
  * Stamp
  * PYMS
* Assess the effect of early versus late enteral nutrition on the outcome and predict the complication associated with enteral feeding.

Malnutrition affects millions of children throughout the World. According to ESPEN nutritional risk screening tools have been designed to detect protein and energy under nutrition and predict if under nutrition may develop or worsen. The Screening was validated Tool for Assessment of Malnutrition in Pediatrics (STAMP) that evaluates patient's clinical diagnosis, nutritional intake during hospitalization and anthropometric measurements, developing a care plan based on the child's overall malnutrition risk. The Screening Tool for Impaired Nutritional Status and Growth (STRONG kids) consists of four items: clinical assessment, high-risk diseases, nutritional intake and losses, weight loss or poor weight gain.

The Pediatric Yorkhill Malnutrition Score (PYMS) is adopted among patients between 1 and 16 years of age assesses four items: BMI, history of recent weight loss, changes in nutritional intake and the expected effect of current medical condition on patient's nutritional status.

Indirect calorimetry, calculated from analysis of the inspired and expired gases, is the best method for evaluating individual energy expenditure.

Protein requirements are highe. The catabolic effects of illness lead to negative nitrogen balance. Randomized protein-supplemented enteral diet achieved 3.1g/kg/day protein and positive nitrogen balance by PICU day 5.

Enteral nutrition is more physiological, simpler, can be started more quickly and cheaper, it does not require special preparation, and it can be started and modified at any time.

Par enteral nutrition has reserved for those patients with intestinal obstruction or severe gastrointestinal damage, ischemia, inflammation, hemorrhage, peritonitis and paralytic ileus.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill children aged 1-5 years admitted to PICU.

Exclusion Criteria:

* Infants before the age of one year and children after the age of five years.
* Any child with chronic illness.
* Patients with multiorgans failure.
* Children with congenital anomalies.
* Children on renal dialysis.
A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Weekly Procrit Given to Gastric or Rectal Patients

To demonstrate the effectiveness of epoetin alfa on reduction in red blood cell transfusions in gastric and rectal cancer patients undergoing preoperative chemoradiation therapy followed by surgery.

Anemia and fatigue are common problems in gastric and rectal cancer subjects at the completion of chemoradiation therapy and surgery. Results of several studies in cancer subjects suggest that treatment with epoetin alfa may be effective in maintaining hemoglobin levels, thereby reducing fatigue, decreasing transfusion requirement, and potentially improving quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years of age or older
* Must have a confirmed diagnosis of gastric or rectal cancer for whom the treatment plan is preoperative chemoradiation followed by surgery
* Must have a baseline hemoglobin \>/= 10 g/dl and \< 15 g/dl
* Must have adequate hematologic function
* Must have life expectancy of more than 6 months
* Karnofsky performance status of at least 50%
* Must have adequate renal function
* Patients with reproductive potential must use an adequate contraceptive method during treatment and three months after completing treatment
* Patients must be able to read, understand, and complete the three Quality of Life questionnaires in English.

Exclusion Criteria:

* Prior chemotherapy for patients with rectal cancer
* Gastric cancer patients who have received more than 2 cycles of chemotherapy
* Anemia due to factors other than cancer/chemotherapy
* Patients with prior treatment with epoetin alfa or any investigational forms of erythropoietin within the previous 6 months
* Known hypersensitivity to mammalian-cell derived products or to human albumin
* Pregnant or lactating women
* Untreated Central Nervous System metastases
* Any significant, uncontrolled disease/dysfunction of any of the major organs
* Uncontrolled hypertension or history of uncontrolled cardiac arrhythmias, pulmonary embolism, thrombosis
* New onset or poorly controlled seizures
* History of active second malignancy
* Major infection requiring hospitalization and antibiotics or surgery within 14 days of study entry
* Blood transfusion within 1 month of study entry
* Androgen therapy within 2 months of study entry
Huandao Conditioning Application for Allergic Rhinitis Treatment

The goal of this clinical trial is to learn if the Huandao Conditioning Application works to treat allergic rhinitis in adults. It will also learn about the safety of this application. The main questions it aims to answer are:

Does the Huandao Conditioning Application improve allergic rhinitis symptoms as measured by the Rhinitis Control Assessment Test (RCAT) and nasal airway resistance tests? What medical problems do participants have when using the Huandao Conditioning Application?

Researchers will compare the therapeutic version of the application to a placebo version (a look-alike application that contains no therapeutic effect) to see if the Huandao Conditioning Application works to treat allergic rhinitis.

Participants will:

Use either the therapeutic or placebo version of the application daily for 1 week in Phase 1 Take a 2-week break with no application use Use the opposite version of the application daily for 1 week in Phase 2 Visit the clinic at the beginning and end of each phase for checkups and tests Complete symptom assessment questionnaires before each application use and 1-2 hours after use Be monitored for any adverse reactions throughout the study period

Detailed Description:

Allergic rhinitis (AR) is a chronic respiratory condition affecting 15% of the global population. The study investigates a novel mobile application-based intervention utilizing Traditional Chinese Medicine (TCM) meridian theory.

Study Design:

Randomized, double-blind, placebo-controlled crossover trial Two 1-week treatment periods separated by 2-week washout 1:1 randomization to active/placebo app sequence

Intervention Details:

Therapeutic app: Energy-balancing effects based on TCM meridians Placebo app: Visually identical without therapeutic properties Daily 5-10 minute self-administered sessions Symptom tracking before and 1-2 hours post-application

Assessment Schedule:

Baseline: RCAT, allergen screening, nasal resistance Treatment weeks: Daily symptom monitoring, Day 4 phone follow-up End of phases: RCAT, nasal resistance, adverse events Study completion: Additional allergen screening

Target Population:

95 participants Recruitment via posters at Hualien Tzu Chi Hospital Expected 70 evaluable subjects for analysis

This study aims to evaluate the efficacy and safety of a TCM-based digital therapeutic for AR symptom management.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* RCAT score \< 21
* Positive allergen screening (\> 0.35 KU/L for house dust, microbial, or pet dander)
* Capable of operating mobile app and completing follow-up

Exclusion Criteria:

* Recent diagnosis, active treatment, or recurrence risk of head/neck cancer
* Current or previous immunotherapy
* Any condition that may compromise participant safety or interfere with trial assessment per investigator judgment
A Study of the Immunogenicity of BCG, Delivered Intradermally in Healthy Volunteers

To assess the immunogenicity of M. bovis BCG (SSI strain), given intrademally in the standard dose used in clinical practice and to measure the development of the immune response in the first six months after administration. M. bovis BCG is a fully licensed vaccine that has been in routine clinical use for the last 50 years. It is the most widely administered vaccine in the world today and has an excellent safety record.

Volunteers for the study will be recruited through advertisements. Each volunteer will have received an information sheet concerning the study and will have agreed to participate in writing.

Volunteers will be given at least 48 hours between reading the information leaflet and agreeing to participate. Female volunteers will have a pregnancy test prior to enrollment. Volunteers will give signed consent for their GP's to be notified about their participation in the trial. The GP will be faxed a letter on the day of screening and asked to reply if they know of a reason why the volunteer should not take part. The signed consent form will also be faxed with the letter.

A week after the screening visit and after a negative Heaf test, subjects will receive a single intradermal injection of 106 cfu M. bovis BCG in 0.1ml just inferior to the insertion of the deltoid muscle. Blood tests will be taken at the screening visit and day of immunisation, 1 and 2 weeks, and 1, 2, 3 and 6 months after the immunisation. 75mls will be taken on the screening visit, and 60mls will be taken on all subsequent visits. Screening samples will be tested for full blood count, biochemical screen and immunological assays to determine vaccine immunogenicity. Peripheral blood mononuclear cells will be prepared for cellular immunological assays to be performed without or following cryopreservation. Other serological measures of immune response, i.e.

antibody titres, will be assayed on frozen plasma samples. All blood tests will be taken within 1-3 days of the due date as described in the schedule above.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult aged 18-65 years.
* Normal medical history and physical examination.
* Normal urine dipstick, blood count, liver enzymes, and creatinine.

Exclusion Criteria:

* Exposure to TB/BCG vaccination at any point. Previous residence in a TB endemic area.
* Clinically significant history of skin disorder (eczema, psoriasis, etc.), allergy, immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness, psychiatric disorder, drug or alcohol abuse.
* Oral or systemic steroid medication or the use of immunosuppressive agents.
* Positive HIV or core HBV antibody test.
* Positive Heaf test
* Positive ANA or serum anti-DNA antibody.
* Confirmed pregnancy