cyrilzakka/clinical-trials huggingface dataset:
Autologous Tumor-Infiltrating Lymphocyte (GTE-001 Injection ) for Treatment of Patients with Advanced Lung Adenocarcinoma

This study is a Multiple centers, open design aimed at evaluating the safety,efficacy and Production feasibility of Autologous Tumor-Infiltrating Lymphocyte (GTE-001 injection ) for treatment of patients with Advanced lung adenocarcinoma,And evaluate potential biomarkers related to GTE-001 activity.


Eligibility Criteria:
Inclusion Criteria:

* 1. Voluntarily join the study, signed informed consent form， willing and able to comply with the study protocol;
* 2. Age ≥18 years old;
* 3. Advanced lung adenocarcinoma that progresses after recurrence or first-line chemotherapy；
* 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
* 5. Expected survival time of ≥ 3 months;
* 6. Good function of vital organs;
* 7. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.

Exclusion Criteria:

* 1.Subject has previously received an allogeneic stem cell transplant or organ allograft,Subject has previously received engineered cell therapy,Prior FOLR1 directed therapy is not allowed unless it had been with an approved agent in the indication;
* 2.Subject has undergone surgery or received radiotherapy, immunotherapy, targeted therapy agents, anticancer vaccines, systemic steroids, or chemotherapy within 2 weeks of enrolment. Targeted agents, such as tyrosine kinase inhibitors, may be continued until 5 half-lives before enrolment;
* 3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 12 months after cell infusion;
* 4.History of central nervous system (CNS) disorder,History of autoimmune disease,History of primary immunodeficiency;
Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study

Primary objective :

To evaluate the efficacy (in terms of change in HbA1c readings starting from baseline then after 13 weeks \& at the end of the study which will be after 26 weeks) in subjects with type I diabetes mellitus.

Secondary objective :

* Recording the average daily dose of both insulin Glulisine \& insulin Glargine in type I DM.
* Recording adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed type I diabetic patients
* Type I diabetes treated with basal-bolus regimen including 3 or more injections of Regular Human Insulin per day
* BMI, 26-40 kg/m2
* HbA1c, 7.5%-10%
* Median 2Hrs post -prandial more than or equal to 140 mg/dl (more than or equal to 7.8 mmol/L)
* FPG more than or equal to 120 mg/dl (more than or equal to 6.7 mmol/L)
* Willingness to accept, and ability to inject insulin Glargine therapy

Exclusion Criteria:

* Pregnancy : The use of LANTUS \& APIDRA during pregnancy is not contraindicated. However, in the absence of supportive data, Sanofi- Aventis Pharmaceuticals cannot specifically recommend the use of Lantus in this patient population

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Rosiglitazone In Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin

This 24-week study will compare the effects of adding the drug rosiglitazone (2mg and 4mg) or placebo to insulin in patients with Type 2 diabetes mellitus (non-insulin-dependent) who have not achieved their blood glucose goal using insulin alone. This study requires a total of seven visits during 28 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have Type II diabetes mellitus (non-insulin-dependent).
* Females must be post-menopausal (\> 12 months without a menstrual period), surgically sterile, or must be using oral contraceptive, Norplant, Depo-provera, an IUD, or a diaphragm with spermicide or condoms. Females of childbearing potential must use acceptable contraceptive measures for at least one month prior to screening and for 30 days after completing the study.
* Must have been on insulin therapy alone continuously for at least 8 weeks prior to screening (minimum dose of 30 units per day). Patients taking insulin in combination with a single oral antidiabetic agent may have their oral agent discontinued and their insulin dose optimized over an 8 week period prior to screening if they are considered good study candidates in all other respects.
* HbA1c \> 7.5% at Pre-screen or at Screen for subjects who discontinue their antidiabetic agent at pre-screening.
* Provide signed Informed Consent.

Exclusion Criteria:

* Females who are lactating, pregnant, or planning to become pregnant.
* Use of any drug called a thiazolidinedione within 6 months prior to screening, or more than one oral antidiabetic agent (including combinations of agents such as Glucovance) in combination with insulin in the 3 months prior to screening.
* Use of any investigational drug for blood glucose control within 3 months of screening regardless of the treatment regimen, or use of any other investigational agent within 30 days preceding study entry.
* Use of niacin (not including doses found in multivitamins) or oral corticosteroids within 3 months of screening.
* Patients with ongoing swelling due to fluid accumulation or history of such requiring treatment with a drug in the 12 months prior to screening.
* Patients with a documented history of significant hypersensitivity (e.g., difficulty swallowing, difficulty breathing, tachycardia or skin reaction) to the drugs called thiazolidinediones or similar drugs, or with prior fluid related intolerability to thiazolidinediones.
* Presence of clinically significant kidney or liver disease.
* Anemia.
* Presence of unstable or severe angina or coronary insufficiency.
* Patients with ongoing CHF (chronic heart failure) or history of CHF.
* Recent history or suspicion of current drug abuse or alcohol abuse.
This Study Will Describe the Burden of DENgue Fever Virus (DENV) Illness Among Household Members Aged 6 Months to 50 Years of Selected Communities in Latin America and Southeast Asia

The purpose of this study is to describe the burden of DENV illness among household members aged 6 months to 50 years of selected communities in Latin America and Southeast Asia.


Eligibility Criteria:
Inclusion Criteria:

* Written and signed informed consent (and assent if the subject is below the legal age of consent) obtained from the subject/from subject's parent(s)/LAR(s). For a subject below the legal age of consent is, his/her signature will be obtained on the informed assent form, if applicable.
* A male or female between, and including 6 months and 50 years of age at the time of enrolment (Subjects become ineligible on their 51st birthday).
* Subject and/or the subject's parent(s)/LAR(s) who the investigator believes can comply with the requirements of the protocol (e.g., willingness to go to the hospital/healthcare centre for visit(s) in case of acute febrile illness, able to observe the signs of dengue and to understand how to take and report body temperature, etc).
* Subject who plans, at the time of enrolment, to remain at same residence/study area during the one or two year study period (as applicable).
* Household should be reachable by phone (residence phone or mobile phone). Note: Pregnant or lactating female or female planning to become pregnant can be recruited into the study.

Exclusion Criteria:

* Child in care.
* Participation (current or planned) in another epidemiological study or in a clinical trial that would conflict with the current study, based on investigator's judgement.
* Terminal illness or severe mental incapacity.
Study of FYU-981 in Hyperuricemia With or Without Gout

The purpose of this study is confirmatory investigation of safety and efficacy of FYU-981 administered orally to hyperuricemic patients with and without gout for 34 or 58 weeks by the method of multicenter, open label and ascending dose regimen.


Eligibility Criteria:
Inclusion Criteria:

* Hyperuricemic or gout patients
* Serum urate level:

\>= 7.0mg/dL in patients with history of gout, or \>= 8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or \>= 9.0mg/dL

Exclusion Criteria:

* Gouty arthritis within two weeks before start of study treatment
* Secondary hyperuricemia
* HbA1c: \>= 8.4%
* Uric acid-overproduction type in the classification of hyperuricemia
* History of, clinically significant cardiac, hematologic and hepatic disease
* Kidney calculi or clinically significant urinary calculi
* eGFR: \< 30mL/min/1.73m\^2
* Systolic blood pressure: \>= 180 mmHg
* Diastolic blood pressure: \>= 110 mmHg
Causes and Characteristics of Occupational Eye Injuries in Western Turkey

Patients with work-related eye injuries (WREI) admitted to the center in the four-year period were enrolled in this prospective study. Institutional Review Board approval was obtained before commencement of the study. A special data recording system was developed for the study. The study sample comprised only the casualties occurred at workplace and while working de facto. The data were abstracted via face to face contact in the emergency department (ED). The data sheets comprised sociodemographic and injury-related information brought together in 15-item questionnaire. Causes of occupational injuries as reported by the victims were assigned to either of two groups: "Worker-related causes" and "workplace-related causes".

Since workers are known to be pressured by the workplace to work in unsafe ways, an isolated room in the ED was used for this purpose in order to prevent bias and the patients were not accompanied by any person other than the medical personnel in charge of due medical care. The patients were also assured that the information obtained by the survey are to be used for research purposes only and no feedback is to be given to employers or related persons.

Patients who did not give consent for the study, fatal accidents and patients younger than 15 years of age were excluded from the analysis.

All data obtained in the study were recorded in and analyzed using the Statistical Package for Social Sciences for Windows, Version 17. Numerical variables were given as mean and standard deviation (SD), while categorical variables were given as frequencies (n) and percentages.

Eligibility Criteria:
Inclusion Criteria:

* The study sample comprised only the casualties occurred at workplace and while working de facto

Exclusion Criteria:

* Other
A Study of Safety and Efficacy of Infliximab (Remicade) in Patients With COPD

The purpose of this study is to evaluate the safety and effectiveness of infliximab (Remicade) in patients with Chronic Obstructive Pulmonary Disease (COPD). Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.

Chronic Obstructive Pulmonary Disease (COPD) is a smoking-related inflammatory lung disease that results in reduced lung function, causing the symptoms or problems that you have when breathing. COPD includes both chronic bronchitis and emphysema. The symptoms of COPD are cough, sputum (phlegm) production, breathlessness, and wheezing. Advanced disease may also involve changes in appetite and weight loss. The drug used in this study is called Remicadeâ, and the active component is called infliximab. Infliximab binds to and blocks the activity of a naturally occurring substance in the body called tumor necrosis factor alpha or TNFa, which may be associated with inflammation and a decrease in lung function.The purpose of this study is to evaluate the safety and effectiveness of infliximab in the treatment of patients with symptoms of moderate to severe COPD.Patients will be receive infusions of either placebo, 3 mg/kg infliximab or 5mg/kg infliximab at weeks 0, 2, 6, 12, 18, and 24.Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. Patients will receive infusions of either placebo, 3 mg/kg infliximab or 5mg/kg infliximab at weeks 0, 2, 6, 12, 18, and 24.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have moderate or severe COPD
* Patients must have at least one episode of COPD-related symptoms (eg, cough, sputum production, shortness of breath) within 2 months prior to screening Exclusion Criteria:
* Patients must not have asthma as main component of obstructive airway disease
* Patients must not have had a moderate or severe exacerbation of COPD within previous 1 month
Effect of Intrathecal Dexamethasone on Intra-operative Hemodynamic in Elderly Patients Undergoing Urologic Endoscopic Surgery

Correction of Post-spinal anesthesia hypotension by fluids pose the risk of volume overload or compromising cardiac conditions. Intravenous Dexamethasone in some studies is used to treat conditions manifested by decrease of peripheral vascular resistance Many advantages were investigated for the addition of dexamethasone to bupivacaine in spinal anesthesia as prolongation of anesthesia time, postoperative analgesia and prophylaxis for shivering.

In this study the investigators will investigate the ability of dexamethasone to blunt post-spinal anesthesia hypotension in elderly patients undergoing urological endoscopic surgery, and hence, if it decreases amount of fluids and dose of vasoactive drugs.

Spinal anesthesia is the most consistent block for lower abdomen and lower limb surgery. Spinal anesthesia avoids the risks of general anesthesia such as aspiration of gastric contents and difficulty with airway management.

Post-spinal anesthesia hypotension in elderly patients is challenging. Correction of Post-spinal anesthesia hypotension by fluids either colloids or crystalloids or by vasoconstrictors pose the risk of volume overload or compromising cardiac conditions. Intravenous Dexamethasone in some studies is used to treat conditions manifested by decrease of peripheral vascular resistance.

Many advantages were investigated for the addition of dexamethasone to bupivacaine in spinal anesthesia as prolongation of anesthesia time, postoperative analgesia and prophylaxis for shivering. Avoidance of complications of opioids is a great issue as, postoperative nausea, vomiting, respiratory depression, urinary retention, prolonged hospital stay and immunosuppression.

In this study the investigators will investigate the ability of dexamethasone to blunt post-spinal anesthesia hypotension in elderly patients undergoing urological endoscopic surgery, and hence, if it decreases amount of fluids and dose of vasoactive drugs.

Eligibility Criteria:
Inclusion Criteria:

* Age: \> 60 years old
* Gender: Males and females
* ASA grade I - II - III
* Patients undergoing elective endoscopic urological procedures.

Exclusion Criteria:

* Patient refusal.
* Suspected massive bleeding.
* Transition to open abdominal surgery
Could Tai-chi Help Maintain Balance of Spinocerebellar Ataxia Patients

Spinocerebellar atrophy is the most common autosomal dominant inherited ataxia. There are over thirty subtypes, which characterize neurologic features differently. They all have obvious substantial cerebellar atrophies in image, and unstable gait、ataxia. In general a prevalence of about three cases per 100 000 people is assumed, but this may be an underestimate. Progressive neurologic degeneration, in about 10-20 years, will leads to disability or wheelchair-dependent. Accompanying with fatigue, downhill course of the disease often made patients depressive and hopeless. The recent review of researches concludes no effective therapy for the disease. The purpose of the investigator's study is to explore the Tai-chi exercise effect for spinocerebellar ataxia.


Eligibility Criteria:
Inclusion Criteria:

* progressive ataxia accompanied with the observation of cerebellar atrophy on magnetic resonance or computed tomography images
* SARA score of less than 20

Exclusion Criteria:

* Patients with complicated cerebellar disorders, such as multiple system atrophy, Parkinson-plus syndromes, secondary cerebellar degeneration from encephalitis, trauma, hypoxia, cerebrovascular diseases, and toxic- or drug-induced cerebellar degeneration
* SARA score of larger than 20
Cognitive Outcomes of Brain Stimulation As a Later-in-Life Treatment

This is a pilot study being done to attempt to improve episodic memory problems in persons with mild cognitive impairment (MCI) or dementia. The pre-supplemental motor area (preSMA) and dorsal anterior cingulate cortex (dACC) have been shown to play a role in episodic memory and language retrieval. Prior studies have suggested that neurostimulation targeting this region can improve episodic memory and word recall. The purpose of this study is to examine the efficacy of high-definition transcranial direct current stimulation (HD-tDCS) to the preSMA/dACC region and its influence on word retrieval and other cognitive functions in patients with MCI or dementia. Entraining the preSMA/dACC circuit with 10 sessions of HD-tDCS will allow us to study whether neurostimulation may be an effective treatment.

The research objective of this study is to examine the efficacy of HD-tDCS to the preSMa/DaCC region and its influence on word retrieval and other cognitive functions in patients with MCI or dementia after 10 sessions of HD-tDCS. There will be two treatment arms: active HD-tDCS (1 mA) and a sham group. For Phase 1, participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) or sham across 2 weeks. Word retrieval and other cognitive tasks will be completed at baseline, immediate follow-up after session 10, and a 2-month follow-up. For Phase 2, participants randomized into the sham group will have the opportunity to return after 2 months and receive the active treatment while being unblinded to their treatment condition. Following 10 active treatment sessions, word retrieval and other cognitive tasks will again be completed immediately following the last HD-tDCS session and then a 2-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

Active diagnosis of mild cognitive impairment or dementia, Female and male subjects, All races/ethnicities, Age 55 years and older, Fluent in English,

Exclusion Criteria:

Lifetime history of major neurologic syndromes (e.g., epilepsy, brain tumor, etc), Substance use disorder within the past year, Has metal fragments in skull/head, Current vision or hearing impairment that interferes with testing, Current medication use known to alter HD-tDCS reactivity
Respiratory Trends During Blood Transfusions in Newborns.

The prevalence of transfusion reactions is between 1 and 11% of transfusions. Most reactions are mild and do not pose a life-threatening risk to the patient. More serious problems may be the only manifestations that lead to suspicion of a transfusion reaction.

Most noninfectious transfusion reactions are immune-mediated. Two main types of reactions can be distinguished: TACO (transfusion associated cardiac overload, which is a cardiogenic pulmonary edema) and TRALI (transfusion related acute lung injury, non-cardiogenic pulmonary edema).

Although TRALI are diagnoses of exclusion, the presence of noncardiogenic pulmonary edema and respiratory problems in the vicinity of blood product transfusions should raise suspicion. Other signs of TRALI are hypotension and tachycardia, while in TACO arterial hypertension with positive water balance can be observed.

According to previous reports, the prevalence of transfusion reactions in the neonatal population is approximately 8%. Factors associated with these reactions are low birth weight and low gestational age. However, diagnostic criteria of respiratory transfusion reactions are not uniform across studies, and often the generic terms "acute lung injury" have been used.

Therefore, the primary objective of this study is to evaluate the respiratory trend during blood transfusions; secondary objectives are the study of risk factors for the development of respiratory worsening and the possible association with complications.


Eligibility Criteria:
Inclusion Criteria:

* admitted newborns requiring blood transfusions as per local practice and/or international guidelines

Exclusion Criteria:

* newborns with major malformations
* need for palliative care
* lack of informed consent
MRI in Finding Hypoxia in Patients Undergoing Chemo and Radiation for Head and Neck Cancer

RATIONALE: Diagnostic procedures, such as functional MRI, may help measure oxygen levels in tumor cells and may help in planning cancer treatment.

PURPOSE: This phase I trial is studying functional MRI to see how well it works in finding hypoxia in patients undergoing chemotherapy and radiation therapy for stage III or stage IV head and neck cancer.

OBJECTIVES:

* Determine the undertaken oxygen sensitive MRI for the detection of hypoxia in patients with Stage III-IV head and neck cancer.
* Correlate MRI parameters with histology, gene expression, and plasma osteopontin.
* Correlate tumor hypoxia measurements with patient prognosis and treatment response.

OUTLINE:

* Pre-therapy MRI: Patients undergo blood oxygen level dependant (BOLD) contrast MRI on room air breathing over 2 minutes and with oxygen gas over 15 minutes. Patients also undergo MR-spectroscopy over 15 minutes to measure choline and lactate markers, and dynamic contrast MRI with gadolinium contrast over 8 minutes.
* Chemoradiotherapy: Patients receive platinum based chemotherapy every two weeks. Patients also undergo radiation therapy for 6 weeks.
* Post-radiation MRI: Patients undergo MRI as before chemoradiotherapy. Blood and tumor samples are collected at baseline for biomarker analysis associated with tumor progression or response.

After completion of study, patients are followed every 3 months for up to 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed squamous cell carcinoma of the head and neck

  * Stage III or IV disease
* Measurable disease
* Scheduled to undergo standard treatment including radiation therapy and chemotherapy
* Participation on study # 092004-010 for tissue procurement

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Serum creatinine ≤ 1.5 OR creatinine clearance ≥ 40
* Body mass index ≤ 34 Kg/m\^2
* Not claustrophobic
* No other contraindications to MRI (i.e., implanted pacemaker device)
* Not pregnant or nursing
* Negative pregnancy test
* No allergy to gadolinium

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics