cyrilzakka/clinical-trials huggingface dataset:
Apatinib Plus Docetaxel as 2nd Line Treatment in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer

The purpose of this Phase II, Open-label, single arm, exploratory study is to evaluate the efficacy and the safety of Apatinib（500mg/d）with docetaxel (60 mg/m²) in advanced Non-squamous Non-small cell lung cancer after failure of first line chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 and ≤ 75 years of age
* Histologically or cytologic confirmed advanced non-squamous and non-small cell lung cancer.
* EGFR mutation testing negative of sensitive mutations
* At least one measurable lesion which has not received radiotherapy (larger than 10 mm in diameter by spiral CT scan)
* Have failed for 1 lines of chemotherapy
* ECOG performance scale 0 - 1.
* Life expectancy of more than 3 months.
* Duration from the last therapy is more than 6 weeks for nitroso or mitomycin
* More than 4 weeks after operation or radiotherapy
* More than 4 weeks for cytotoxic agents
* Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 80×10\^9/L, neutrophils ≥ 1.5×10\^9/L, total bilirubin within 1.25×the upper limit of normal(ULN), and serum transaminase≤2.5×the ULN (If liver metastases, serum transaminase≤5×the ULN), serum creatine ≤ 1.5 x ULN, creatinine clearance rate ≥ 50ml/min,
* Signed and dated informed consent.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion Criteria:

* Received more than one kind of chemotherapy regimens
* NSCLC received other VEGFR inhibitors (except beacizumab) or docetaxel chemotherapy
* Existing therapy related toxicity of prior chemotherapy and/or radiation therapy
* Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
* Any factors that influence the usage of oral administration
* The center of the tumor invaded local large blood vessels
* Within 4 weeks before the first use of drugs, occurs pulmonary hemorrhage (≥ CTCAE class 2) or other parts' hemorrhage (≥ CTCAE class 3).
* Within 6 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc.
* Less than 4 weeks from the last clinical trial
Influence of Multi-dimensional Wellness Program on Quality of Life

The purpose of this study is to determine whether multi-dimensional wellness program (diet, art and biofield therapy) influences the quality of life for those with different health status in Japan.

Combination of wellness programs may be one of the best approaches to improve quality of life; however, the effectiveness of a treatment that combines various programs is also yet to be clarified. This study investigated the influence of Okada Health and Wellness program on the quality of life for healthy people and those with illness in Japan. Okada Health and Wellness program consists of 3 components: diet, art and biofield therapy.

Eligibility Criteria:
Inclusion Criteria:

* Those who were interested in practicing the diet program and art therapy established by the MOA International Corporation.
* Able to receive Okada Purifying Therapy, a domain of biofield therapy at least once a week.
* Competent to answer the Japanese questionnaires for quality of life
* Aged 16 years or older

Exclusion Criteria:

* Those who did not match the inclusion criteria
Effect of a Nasal Bolus Allergen Challenge on Inflammatory Markers

The current study will investigate nasal inflammatory markers obtained by filter paper collection techniques, in subjects with allergic rhinitis, determining the most appropriate time points and handling conditions, prior to running a larger study with subjects with allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects with allergic rhinitis, that have a positive skin prick response to Phleum pratense.

Exclusion Criteria:

* Subjects with a history of asthma. Current smokers, or recent ex-smokers and subjects that have had a respiratory tract infection in the previous 4 weeks.
Active Screening of Latent TB Infection, Treatment and Long Term Follow-up in Prison

LTBI Treatment is effective in prison

LTBI treatment will be conducted in a prison with either isoniazid or rifampin

Eligibility Criteria:
Inclusion Criteria:

* all people who is LTBI, and have ability to sign the informed concent

Exclusion Criteria:

* previously adverse effect from anti-TB medication complete treatment of TB in the pass; active TB AST, ALT \> 3 times of normal limit platelet \< 150 k/mm3 T-bil \> 2 times of normal limit
Biomarkers in Blood Samples From Young Patients With Newly Diagnosed Brain Tumors Undergoing Standard Radiation Therapy and Chemotherapy

RATIONALE: Studying samples of blood in the laboratory from patients receiving radiation therapy and chemotherapy may help doctors learn more about the effects of this treatment on cells. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research study is studying biomarkers in blood samples from young patients with newly diagnosed brain tumors undergoing standard radiation therapy and chemotherapy.

OBJECTIVES:

Primary

* Evaluate the fraction of peripherally circulating T-regulatory cells (T_regs) in pediatric patients with newly diagnosed medulloblastoma and compare it to the levels found in a control group of patients undergoing craniectomy for Chiari malformation.
* Evaluate the longitudinal effects of standard radiotherapy and chemotherapy regimens on the overall population of lymphocytes as well as the fraction of T_reg cells in patients with medulloblastoma.

Secondary

* Determine the baseline fraction of T_reg cells in those with non-medulloblastoma posterior fossa tumors compared to levels found in patients undergoing decompression for Chiari malformation.

OUTLINE: This is a multicenter study.

Patients with Chiari malformation and patients with posterior fossa tumor undergo standard surgery. Patients with posterior fossa tumor also receive standard radiotherapy and chemotherapy.

Blood samples are collected at baseline and periodically to measure the level of circulating T-regulatory cells.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Histologically confirmed posterior fossa tumor

    * Newly diagnosed disease
    * Medulloblastoma OR non-medulloblastoma (pilocytic astrocytoma, ependymoma, atypical rhabdoid tumor, or others)
    * Scheduled to undergo craniotomy and tumor resection
  * Chiari malformation

    * Requires craniectomy for decompression

      * No secondary decompression

PATIENT CHARACTERISTICS:

* No unexplained febrile illness
* No active infection
* No autoimmune disorders such as inflammatory bowel disease, juvenile rheumatoid arthritis, or systemic lupus erythematosus
* No other immunosuppressive disorders (e.g., HIV infection)

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
A Study of Teclistamab in Japanese Participants With Relapsed or Refractory Multiple Myeloma

The purpose of the study is to evaluate the safety and tolerability in Japanese participants with relapsed or refractory multiple myeloma (RRMM) at the recommended Phase 2 dose (RP2D) identified in Study 64007957MMY1001 (NCT03145181) in Phase 1 part and to evaluate the efficacy of teclistamab at RP2D for Japanese participants in Phase 2 part.


Eligibility Criteria:
Inclusion criteria:

* Documented diagnosis of multiple myeloma (MM) according to International Myeloma Working Group (IMWG) diagnostic criteria
* Participant must have measurable disease defined by any of the following: Serum M-protein level greater than or equal to (\>=) 1.0 gram per deciliter (g/dL); Urine M-protein level \>= 200 milligrams per 24 hours (mg/24 hours); or Light chain MM, for participants without measurable disease in the serum or urine: serum Ig-free light chain (FLC) \>=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa-lambda FLC ratio; or if central laboratory assessments are not available, relevant local laboratory measurements must exceed the minimum required level by at least 25 percent (%)
* Participant must be relapsed or refractory to established therapies with known clinical benefit in relapsed/refractory MM or be intolerant to established MM therapies and a candidate for teclistamab treatment in the opinion of the treating physician. Prior lines of therapy must include a proteasome inhibitors (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody in any order during the course of treatment. Participants who could not tolerate PI, immunomodulatory drugs, or anti-CD38 antibody are allowed
* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and immediately before the start of study treatment administration
* Woman of childbearing potential must have a negative pregnancy test at screening and within 24 hours prior to the first dose of study treatment using highly sensitive pregnancy test either serum (beta-human chorionic gonadotropin \[beta-hCG\]) or urine

Exclusion criteria:

* Prior treatment with any B cell maturation antigen (BCMA)-targeted therapy
* Toxicities from previous anticancer therapies that have not resolved to baseline levels or to less than or equal to (\<=) Grade 1 except for alopecia or peripheral neuropathy
* Received a cumulative dose of corticosteroids equivalent to \>=140 mg of prednisone within the 14-day period before the first step-up dose of study treatment (does not include pretreatment medication)
* Stem cell transplantation: An allogeneic stem cell transplant within 6 months. Participants who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease; Received an autologous stem cell transplant less than or equal (\<=) 12 weeks before the first step-up dose of study treatment
* Central nervous system involvement or clinical signs of meningeal involvement of MM. If either is suspected, whole brain magnetic resonance imaging (MRI) and lumbar cytology are required during screening
Determining the True Incidence of Atrial Fibrillation Before and After Lung Resection

Lung resections for pulmonary malignancies offer the best chance of survival for patients, but these procedures carry a significant burden of post-operative morbidity and mortality. Patients are particularly at high risk for post-operative atrial fibrillation (a condition involving irregular heart rhythm). Atrial fibrillation with symptoms can increase the risk of stroke - a blockage in a major blood vessel in the brain, which can potentially result in a disability or even death. The objective of this study is to establish the feasibility of using ambulatory heart rate monitoring to determine the total incidence of atrial fibrillation in the peri-operative period before and after anatomic lung resection for malignancies. The study will also investigate the correlation between atrial fibrillation and rates of stroke and other adverse events, as well as serve to identify the patients that are at a higher risk of developing atrial fibrillation.

Novel literature suggests that atrial fibrillation that is asymptomatic may just be as problematic as atrial fibrillation that presents itself with symptoms. The objective of the study is to establish the feasibility of tracking the total incidence of atrial fibrillation in the peri-operative period, including both symptomatic and asymptomatic events, using an ambulatory heart monitor. Additionally, the study aims to estimate the overall incidence of peri- and post-operative atrial fibrillation. These will be accomplished through usage of iRhythm ZIO XT, a small pebble shaped device that will be adhered to the patient's chest for 14 days before and after surgery, to measure how often atrial fibrillation occurs.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be at least 18 years of age and competent to consent
* Patients must be diagnosed with resectable lung cancer or metastatic lung disease eligible to complete metastasectomy
* Patients must have one of: Male gender, age greater than 65, hypertension, obesity, and recent tobacco use within the past year
* Patients must be booked for pneumonectomy, lobectomy or anatomical segmentectomy resection.

Exclusion Criteria:

* Patients undergoing emergent lung resection
* Patients undergoing lung resection for non-oncologic indications (lung biopsy, bullectomy)
* Patients with an existing neurostimulator
* Patients with pre-existing cardiac disease, defined as:

  * Patients with atrioventricular blockage of any degree or sick sinus syndrome;
  * Patients with known previous atrial fibrillation or flutter lasting more than 1 month;
  * Patients with any persistent diagnosed preoperative arrhythmia
  * Patients with implanted external defibrillators or pacemakers
* Patients with known adhesive allergies
* Inability to comply with or understand ambulatory monitoring.
The Role of HIF-2a in the Pathogenesis of Reflux Esophagitis

The purpose of this study is to determine the role of hypoxia inducible factor (HIF)-2a on the production of inflammatory cytokines that lead to reflux esophagitis.

Reflux esophagitis is thought to be caused by gastric acid that refluxes into the esophagus, causing injury. Newer data suggest that reflux of gastric juice into the esophagus stimulates HIF-2a, which increases production of inflammatory cytokines. These cytokines are thought to lead to reflux esophagitis. The investigators plan to study the relationship of HIF-2a to inflammatory cytokines in patients with known gastroesophageal reflux disease and reflux esophagitis.

Eligibility Criteria:
Inclusion Criteria:

* U.S Veteran
* History of Los Angeles Grade C erosive esophagitis

Exclusion Criteria:

* Inability to provide informed consent
* Esophageal varices
* Warfarin use
* Coagulopathy that precludes safe biopsy of the esophagus
* Comorbidity that precludes safe participation in the study
* Allergy to fluorescein sodium
* Pregnancy
A Study Evaluating AMG 193 in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion

The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted gastrointestinal, biliary tract, or pancreatic cancers. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted gastrointestinal, biliary tract, or pancreatic cancers.


Eligibility Criteria:
Subprotocol B

Inclusion:

* Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
* Histologically or cytologically confirmed diagnosis of metastatic and/or unresectable (locally advanced) adenocarcinoma of the pancreas.
* Tumor tissue (FFPE sample) or an archival block must be available. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before dosing.
* Homozygous MTAP-deletion.
* Disease measurable as defined by RECIST v1.1.
* Adequate organ function as defined in the protocol.

Exclusion:

* Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.
* Radiation therapy within 28 days of first dose.
* Major surgery within 28 days of first dose of AMG 193.
* Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
* Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis).
* History of solid organ transplantation.
Allium Sativum Extract as an Irrigant

Garlic extract as herbal compound has potent antibacterial properties and can be used safely as an irrigant for pulpectomy procedure of primary molars root canals with high clinical and radiographic outcomes

Aim: This study indented to assess the clinical and radiographic assessment of garlic extract as an intracanal irrigant for pulpectomy of primary molars.

Methodology: 91 child with 100 teeth submitted into this study were equally categorized into the test group (group 1) which irrigated with garlic extract and control group (group 2) that received sodium hypochlorite (NaOCl). Then, each group has been subjected to further specification according to the tooth preoperative clinical and radiographic features into has been into 2 subgroups. Clinical and radiographic success rates were checked at 3, 6 and 12 months. Fisher's exact test for binary variable was used for data analysis with p-value ≤ 0.05.

Eligibility Criteria:
Inclusion Criteria:

1. Class I or II according to American Society of Anesthesiologists (ASA)
2. Irreversible pulpititis recognised through; (1) profuse bleeding from root canal orifices after complete debridement of coronal pulp tissue and cannot be dominated by moist cotton pellet. (2) History of lingered thermal pain spontaneous nocturnal pain
3. Necrotic pulp tissues which may be asymptomatic or manifested with dull ache pain
4. Pathological tooth mobility
5. Percussion sensitivity
6. Swelling close to involved tooth accompanied with or without fistula Radiographic characteristics of the root and supporting structures

1. Normal radiographic findings

2. Interruption of lamina dura

3. Furcation radiolucency

Exclusion Criteria:

* Specifications of exclusion

  1. Uncooperativeness of child and/or parents or caregivers behavior
  2. Unrestorable tooth
  3. Presence of internal root resorption
  4. Presence of calcific metamorphosis inside root canals
  5. Presence of root resorption exceeding one third of its length
Effect of Naringenin and Beta Carotene on Energy Expenditure

This study is designed to test the effects of the combination of naringenin (from an extract of sweet oranges) and beta carotene on energy expenditure and glucose metabolism in a single human subject.

The subject will be treated for 8 weeks with the combination of naringenin + beta carotene.

We will conduct the following assessments before the treatment and at the end of eight weeks.

1. Resting metabolic rate
2. Oral glucose tolerance test with glucose and insulin
3. Ambulatory blood pressure
4. Recording of adverse events
5. Body weight

Eligibility Criteria:
Inclusion Criteria:

* Fasting blood glucose \< 200mg/dL

Exclusion Criteria:

* Known allergy to citrus fruits
Continuous Fetal Monitoring During Vacuum Delivery

The investigators have added an additional electrode to the vacuum device for birth in which they can monitor the fetus during delivery.

The investigators have added an additional electrode to the vacuum device for birth in which they can monitor the fetus during delivery. The electrode is a standard one inserted in the vacuum device.

Eligibility Criteria:
Inclusion Criteria:

* All fetuses at vacuum delivery

Exclusion Criteria:

* None
Limb Remote Ischemic Preconditioning for Heart and Intestinal Protection During Laparoscopic Colorectal Surgery

Remote ischaemic preconditioning may confer the cytoprotection in critical organs. The investigators hypothesized that limb remote ischemic preconditioning (RIPC) would reduce heart and gastrointestinal function injury in middle-aged and elderly patients undergoing elective laparoscopic colorectal surgery.


Eligibility Criteria:
Inclusion Criteria:

* age \>40 years old
* ASA I-II
* receive elective laparoscopic colorectal surgery
* written informed consent can be obtained

Exclusion Criteria:

* coagulation disorders
* patients with cardiac pacemaker
* patients with severe cardiac,or pulmonary,hepatic,renal disease ,or can not tolerate laparoscopic surgery
* patients with peripheral vascular disease affecting the upper limbs
* patients with mental,or hearing, vision disorder, who is not able to communicate with physicians
* difficult airways that can not receive rapid induction
Wide Excision Alone As Treatment for Ductal Carcinoma in Situ of the Breast

The purpose of this study is to determine if wide excision (surgical removal) alone is adequate treatment for small, grade 1 or 2 ductal carcinoma in situ (DCIS) of the breast.

* Patients with DCIS are usually treated with the combination of breast-conserving surgery and radiation therapy or breast-conserving surgery alone. The purpose of this study is to evaluate whether localized low- or intermediate-grade DCIS, diagnosed with modern mammography and careful pathologic evaluation, could be treated with wide excision alone (omission of radiation therapy) and result in acceptably low local recurrence rates.
* Follow-up consists of physical examinations at least every 6 months by the surgeon or radiation oncologist. Mammograms of the affected breast will be obtained every 6 months for 5 years and then annually. Mammograms of the unaffected breast will be performed annually.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have high quality mammogram including magnification views of the area containing suspicious calcifications.
* A specimen radiograph is required. If the specimen radiograph does not assure removal of all suspicious microcalcifications, a post-operative mammogram showing removal of all suspicious calcifications is required.
* The clinical extent of DCIS must be less than or equal to 2.5 cm.
* Grade 1 or 2 DCIS; patients with lobular carcinoma-in-situ (LCIS) in addition to DCIS in the breast are eligible. Negative margins are not required on the LCIS.
* Patients must undergo a wide excision. A re-excision after the initial biopsy might be needed. Complete resection of the area of DCIS with a histologic margin of at least 1 cm must be achieved.
* Patients must be enrolled on this protocol within 3 months of the last surgical procedure.

Exclusion Criteria:

* Patients with invasive carcinoma including microinvasive disease
* Carcinoma found in the sampled lymph nodes if axillary dissection is done
* Patients with nipple discharge
* Patients with adjuvant chemotherapy or Tamoxifen
* Patients with a history of prior malignancies other than squamous or basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
* Patients with a history of ipsilateral or contralateral breast carcinoma or DCIS or simultaneous bilateral DCIS.
Fatty Acid Levels and Memory in Breastfed Children

Purpose: To explore the relation between breastmilk nutrients and the cognitive abilities of breastfed infants.

Phase 1: Near 3 months of age child and mother saliva samples for DNA obtained with breast milk sample.

Phase 2: At 6 months of age child participates in electrophysiology session to test recognition memory.

Phase 3: At 26 or 38 months of age, children will complete behavioral, dietary, and physical assessments.


Eligibility Criteria:
Inclusion Criteria:

* typically-developing
* exclusively breastfed
* unremarkable delivery

Exclusion Criteria:

* non-English speaking
* history of seizure activity