cyrilzakka/clinical-trials huggingface dataset:
Exercise Training to Improve Cognitive Function

This project is assessing the feasibility of a novel home-based exercise intervention to improve episodic memory in individuals with mild cognitive impairment.

Background/Rationale:

Alzheimer's disease (AD) afflicts nearly 6 million Americans, a number projected to grow in coming decades. AD is known to have a long preclinical phase in which pathophysiologic processes develop many years, even decades, before the onset of clinical symptoms. During this preclinical phase there is evidence of unremitting decline in cognitive function, particularly in episodic memory. Thus far, evidence of the efficacy of pharmacological interventions to slow this decline in cognitive function has been limited, leading to increasing interest in the utility of nonpharmacological interventions including exercise.

Objective:

The investigators propose to assess the feasibility of a novel home-based exercise intervention to improve episodic memory in Veterans with mild cognitive impairment (MCI).

Methods:

The investigators will estimate the difference between the intervention (n=30) and the control group (n=30) on 6-month change in episodic memory (Rey-Osterrieth Complex Figure Test, Wechsler Logical Memory Test) as well as the effect size, which will be used as a basis for sample size calculation for a proposed larger study. Participants will be male and female Veterans 50 years of age or older with amnestic MCI.

Eligibility Criteria:
Inclusion Criteria:

* Amnestic MCI
* Ability to use a telephone without assistance

Exclusion Criteria:

* Angina Pectoris
* History of myocardial infarction within 6 months
* History of ventricular dysrhythmia requiring current therapy
Validation of the Genetic Signature 354849 as a Prognostic Method

This prospective study is focused on the validation of the genetic signature of 27 genes as a predictor of the response to concomitant chemotherapy treatment followed by brachytherapy in patients with locally advanced cervical cancer. The genes included are: ZNF238; SAP30; C10orf137; UHRF1; SUZ12; HMGN4; RBBP4; PPP1CB; SLFN11; FLJ39378; ENDOGL1; RECQL; TRPC1; TRIO; DNAH6; GNL3L; SLC36A2; SRP9; RPE; LDOC1L; PUS7L; CCDC89; LOC644921; PLEKHG1; FAM111B; RPRD2 y ETAA16.

There are several studies of genes or genetic signatures associated with the response to treatment in cervical cancer, but so far it has not been possible to standardize the use of any biomarker or biomarker signature as a predictor of the response to treatment with reproducible results. Therefore, there is still a need to develop an effective method to predict the response to chemo-radiotherapy in locally advanced cervical cancer. This prospective study included 189 patients with cervical cancer clinical stages IB2-IVA, without previous treatment.

Tumor samples will be obtained at the confirmatory diagnostic biopsy. All samples will be processed by the pathology laboratory as usual. The RNA will be extracted from the paraffin blocks with the RNeasy FFPE Kit (Qiagen) according to the manufacturer's recommendations. The RNA will be stored at -20°C until use. Quantitative PCR (qPCR) will be performed with the kit High-Capacity cDNA Reverse transcription Kit (Thermo Fisher Scientific). Primers for the 27 genes will be developed. The relative expression will be calculated using the 2- ΔΔCt method, using the expression of β-actin as a normalizing gene.

In order to obtain the prognostic score, the score assigned by the classifier for the sample will be calculated from the 2-ΔΔCt values obtained for each gene. This will be done by a computer-readable medium containing the type expression profiles related to a good and a bad response to the standard treatment.

Eligibility Criteria:
Inclusion Criteria:

* Women over 18 years old
* Cervical Cancer at IB2-IVA FIGO´s clinical stages
* Histology: squamous, adenosquamous or adenocarcinoma
* No previous treatment
* No distance metastases, discard by PET/CT
* Functional State ECOG (Eastern Cooperative Oncology Group) 0-2
* Candidates to receive standard chemoradiotherapy treatment followed by brachytherapy

Exclusion Criteria:

* Previous chemotherapeutic, surgical and/or radiotherapy treatment for female reproductive tract pathologies
* Previous invasive neoplasia (except non-melanoma skin cancer) unless there is complete remission of the disease of 3 years minimum.
* Previous systemic chemotherapy for the current cervical cancer.
A Study of CD8+ T Cell Imaging During Treatment in People With Non-Small Cell Lung Cancer

The purpose of this study to learn whether PET/CT (positron emission tomography/computed tomography) scans using an imaging agent (radiotracer) called zirconium Zr 89 crefmirlimab berdoxam is a safe and effective way to identify CD8+ T cells


Eligibility Criteria:
Inclusion Criteria:

* Patient must be 18 years of age or older at the time of signing the informed consent.
* Patient has a histologically confirmed diagnosis of metastatic non-small cell lung cancer
* Patient is enrolled in the engineered TIL cell therapy protocol OBX115-23-01, but has not received the treatment yet.
* Men and women of child-producing potential, use of effective double barrier contraceptive methods during the study, up to 30 days after the last administration of the investigational product.
* Patient or legally authorized representative provided signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* Patient or legally authorized representative provided written authorization for use and disclosure of protected health information.

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patients with a history of splenectomy or significant splenic dysfunction (e.g., as evidenced by splenomegaly or a history of recurrent infections due to impaired immune function)
Clinical Trial to Assess the Efficacy and Safety of Combination Therapy of Motireb 5/100 mg in Functional Dyspepsia Patients.

A phase Ⅲ, multi-center, randomized, double-blinded, placebo and active comparator clinical trial to assess the efficacy and safety of combination therapy of Motireb 5/100 mg in functional dyspepsia patients.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female aged 19 years or older
2. Patient with functional dyspepsia met the ROME III criteria or symptom assessment form

Exclusion Criteria:

1. Patient with peptic ulcer or gastroesophageal reflux disease
2. Patients with previous gastrointestinal surgery
3. Patients with history of gastrointestinal bleeding, mechanical obstruction, perforation
4. Patients with history of gastrointestinal cancer
5. Patients with pancreatic disease (pancreatitis, pancreatic cancer, etc), biliary disease, inflammatory bowel disease, acute gastritis.
6. Patients with Zollinger-Ellison syndrome
7. Patients with irritable bowel syndrome
8. Pregnant or lactating women
9. Patients with hepatic abnormality
10. Patients with renal dysfunction or chronic kidney disease
11. Patients who are judged by the investigators to be unsuitable to participate in the clinical trial.
Treatment of Rheumatoid Arthritis With Marine and Botanical Oils

The object of this study is to determine whether treatment of rheumatoid arthritis (RA) with a combination of fish oil and borage seed oil is superior to treatment with either oil alone. This study will also investigate the biochemical, immunological, and molecular mechanism responsible for the therapeutic effects of these fatty acids. Each patient will be followed for eighteen months.

See Brief Summary

Eligibility Criteria:
Inclusion Criteria

* Definite RA with onset at \> 16 years, with total disease duration of at least 6 months
* Active disease as manifested by at least 3 joints that are swollen and 6 joints that are tender at time of enrollment, and either an erythrocyte sedimentation rate \>_28, or a CRP \>1.4, or morning stiffness of at least 45 min
* Stable dose of DMARDs for 2 mos before baseline visit, with total duration of DMARD for 6 mos.
* All standard therapy for RA, including DMARDs and combinations of DMARDs will be allowed as long as doses have been stable for 2 mos
* Stable NSAID for 1 month before baseline if on an NSAID
* Stable prednisone dose of \< 10 mg/day for 1 month before baseline visit, if on prednisone
* Ability to give and understand all elements of informed consent
* Absence of comorbid condition which, in the opinion of the physician-investigator, would render the patient unsuitable for the study
* Willingness to adhere to the clinical protocol.

Exclusion Criteria

* A diagnosis of inflammatory arthritis other than rheumatoid arthritis
* Chronic anticoagulation
* Hypersensitivity to fish or fish products or plant products
* A dose of prednisone of \> 10 mg/day, or either a change in the prednisone dose or intra-articular corticosteroid injection within one month of the baseline evaluation
* An inability or unwillingness to use an effective form of contraception (females) during the duration of the study
* Pregnant and breast-feeding females
* Inability or unwillingness to adhere to the study diet
* Platelet count \< 100,000/mm 3
* Hemoglobin \< 9 g/dl
* Albumin \< 3.3 g
Exercise Training on a Mirror for Intermittent Exotropia Control Post Strabismus Surgery

The study aims to explore the impact of mirror therapy on exodeviation control, near and far strabismus angles, and quality of life in intermittent exotropia control post strabismus surgery, as well as its effects on near and far strabismus angles.

Strabismus is a common childhood disorder causing eye deviation, affecting life quality and cosmetic appearance. Early detection and management improve binocular function and psychosocial problems. Intermittent exotropia is a common type. Surgery is the most common method for correcting strabismus, but complications can be difficult to treat. Physical therapy programs are limited in treating strabismus after surgery, and adding mirror therapy to traditional treatments may help maintain surgery results. This thesis aims to decrease this knowledge gap and improve the treatment of strabismus.

Eligibility Criteria:
Inclusion Criteria:

1. 40 boys and girls with ages from 5 to 15 years
2. History of strabismus surgery from 6 months presence of intermittent exotropia.
3. Normal sensory and motor fusion, equal visual acuity. Good general health condition.
4. Ability to understand and do the exercises at home

Exclusion Criteria:

1. systemic diseases as myasthenia gravis, multiple sclerosis and diabetes
2. Optic nerve injury, organic ocular disease, attention disorder and mental disorders
3. Attention disorder and learning disability
The Effect of Different Dose of Ketamine With Low Dose Rocuronium in Children

Rocuronium is suitable for rapid induction within 60-90 seconds and its effect last 24-40 minute after single bolus injection. For outpatient surgery with short operation time, low dose rocuronium is frequently used for rapid recovery at the expense of compromised intubating condition. For better intubating condition, ketamine can be used. However, appropriate dose of ketamine with low dose rocuronium is not established yet. This study, 3 different doses of ketamine with low dose rocuronium will be compared for appropriate intubating condition.


Eligibility Criteria:
Inclusion Criteria:

* ASA class I, II

Exclusion Criteria:

* upper respiratory infection within 14 days
* anticipated difficult intubation
Pharmacokinetics Study of CKD-11101 and NESP After SC Administration in Health Male Volunteers

The purpose of this study is to investigate the pharmacokinetics of CKD-11101 and NESP after SC administration in health male volunteers

Healthy volunteers are administrated CKD-11101 60μg and NESP 60μg once subcutaneously. (crossover) Every time before and after taking each medication, PK parameters and safety of CKD-11101 60μg and NESP 60μg are performed using a blood sample and conducting some tests(Laboratory test, V/S and Physical Examination, etc) respectively.

Eligibility Criteria:
Inclusion Criteria:

* Signed the informed consent form prior to study participation.
* A healthy male volunteer between 20 and 55 years old.
* Body weight between 55kg and 90kg, BMI between 18 and 27.
* Appropriate subject for the study judging from investigator(physical examination, laboratory test, interview, etc.)

Exclusion Criteria:

* Have the medical history of allergic diseases including hypersensitivity against drug or clinically significant allergic diseases
* Clinically significant hepatic, renal, respiratory system, endocrine system, nervous system, immune system, hematologic, psychiatric, circulatory system, tumor or have history of tumor
* Have abnormal laboratory result.

  * Hemoglobin \< 12g/dL or \> 17g/dL
  * Vitamin B12 \< 200pg/mL
  * Ferritin \< 21.8ng/mL
  * Transferrin \< 190mg/dL
  * Reticulocyte over the normal limit
  * Positive for the Triage TOX drug on urine (cocaine, amphetamines, barbiturates, opiates, benzodiazepine, cannabinoids)
  * Positive for HIV antibody, HBsAg, HCV antibody test
* A heavy smoker (cigarette \> 10 cigarettes per day)
* Administer EPO, darbepoetin, immunoglobulin or IV iron within 3 months prior to the first IP administration
* Have hypersensitivity reactions history for EPO, darbepoetin, excipient of IP or iron tablets
* sit SBP \< 90mmHg or sit SBP \> 140mmHg or sit DBP \< 55mmHg or sit DBP \> 90mmHg or Pulse rate \> 100 per/min
* History of hemoglobinopathy or inflammatory disease or drug abuse within 6 months before screening
* Subject takes ethical drug or herbal medicine within 14 days, OTC or vitamin supplements within 7 days before the first IP administration
* Participated in the other clinical trials and administrated IP within 8 weeks prior to the first IP administration
* A heavy alcohol consumer (alcohol \> 21 units/week) or cannot stop drinking
* Bleed or donate blood (\> 400mL) within 8 weeks before the first IP administration
* Participated in this clinical trials and administrated IP
* Have a diet within 2 days before the first IP administration or cannot stop having

  * food containing grapefruit
  * food containing caffeine
* Disagree to avoid getting pregnant during clinical trial
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result, other reason
Irbesartan-Hydrochlorothiazide Phase IV Study: Treatment of Hypertension in Chinese Population

To analyse the control rate of irbesartan/hydrochlorothiazide(HCTZ) (COAPROVEL) in the treatment of patients with mild to moderate primary hypertension.


Eligibility Criteria:
Inclusion criteria:

* Systolic blood pressure \< 180 mmHg
* 90 mmHg ≤ Diastolic blood pressure \< 110 mmHg

Exclusion criteria:

* Pregnancy or lactation. Women of child bearing potential (not post-menopausal) should be using a reliable contraceptive method
* Known or suspected secondary hypertension (e.g., coarctation of aorta, renovascular stenosis, etc.)
* Presence of clinically significant ventricular or supraventricular arrhythmias, or second or third degree atrioventricular block, or sick sinus syndrome
* ALAT\[SGPT\]\>2 times of upper limit，
* ASAT\[SGOT\]\>2 times of upper limit
* Patients with known renal disease
* Serum potassium \> normal upper limit
* Uncontroled BD（FBG\>10mmol/L or PBG\>12.22mmol/L)
* Patients treated with tricyclic antidepressants
* Clinical hematological disease.
* Patients with a history of irbesartan, or hydrochlorothiazide sensitivity defined as irbesartan, or hydrochlorothiazide discontinuation due to medically significant adverse effects.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Pharmacokinetic Variability of Daptomycin During Prolonged Therapy for Bone and Joint Infections

Daptomycin is a cyclic lipopeptide that has been proposed as an alternative therapeutic option in patients with prosthetic joint infection caused by Staphylococcus or Enterococcus species in the latest Infectious Diseases Society of America (IDSA) guidelines.

The population pharmacokinetics (PK) of daptomycin have been described in various groups of patients in previous publications. However, little information exists on the PK of daptomycin in patients with bone and joint infections (BJI). Also, previous population studies did not investigate daptomycin PK over prolonged therapy, and, to our knowledge, no study has reported the intraindividual PK variability of this drug.

The aim of this study is to describe the inter- and intraindividual PK variability of this drug.


Eligibility Criteria:
Inclusion Criteria:

* patients treated with daptomycin for BJI in Lyon Center in 2012 and 2013

Exclusion Criteria:

-
Prophylactic Use of Filgrastim SD/01 in Patients With Hodgkin's Disease Receiving ABVD Chemotherapy

Prophylactic use of Filgrastim SD/01 for patients with Hodgkin's lymphoma receiving ABVD chemotherapy.


Eligibility Criteria:
INCLUSION:

* Previously untreated Hodgkin's disease patients who are scheduled to receive standard ABVD chemo.
* Histologically proven diagnosis of Hodgkin's disease of any type.
* Bidimensionally measurable disease.
* Signed informed consent.
* Age \>/= 16 yrs.
* Adequate bone marrow reserve (ANC\>1000/uL, Platelet \>100,000/uL.
* LVEF\>/=50% by MUGA scan or echocardiogram.
* Serum creatinine \<2mg/dL; serum bilirubin\<2mg/dL.

EXCLUSION:

* HIV positive.
* Pregnant women and those of child bearing age who are not using adequate contraception.
* Prior chemotherapy.
* Severe pulmonary disease including COPD and asthma.
* History of prior sensitivity to E.coli derived products.
A Phase I-c Study of Recombinant GM-CSF Herpes Simplex Virus to TreatⅣ M1c

Recombinant human GM-CSF herpes simplex virus injection (OrienX010) is a genetically engineered from Chinese patients oral separation of wild type 1 herpes simplex virus (HSV) as the carrier insert GM-CSF gene therapy drug.After gene recombination technology successively removing ICP34.5, ICP47 and insert the deactivation ICP6 gene, and at the site of the original ICP34.5 insert guided by IE promoter of hCMV human gm-csf gene.The drug after tumor site local injections of dosing, on the one hand, because of the soluble tumor characteristics of herpes simplex virus, reconstructing it after HSV-1 virus carrier at the injection site specific "soluble tumor" kill tumor cells;Viral vector expressed in tumor site, on the other hand, to produce high concentrations of GM-CSF enhance the antitumor immune function, play "beside the destruction effect", have inhibition effect on the distant metastases.

Subjects were tested drugs within 8 x 107 pfu/ml tumor injection treatment, the injection quantity according to tumor lesion size, injection amount shall not exceed 10 ml each time, injection frequency for every 2 weeks, 4 times per cycle treatment, treatment 2 cycles. Completed at the end of the second cycle after curative effect evaluation, such as the researchers determine continue to medicine can bring benefit to the subjects, can continue to offer benefits to the subjects' potential drug until disease progression, smaller, not tolerance toxicity or participants to withdraw consent.

Eligibility Criteria:
Inclusion Criteria:

* By histological and/or cytology diagnosis Ⅳ M1c malignant melanoma patients with liver metastasis, the lack of an effective method for the conventional or the failure of conventional therapy or recurrence
* General physical status score (ECOG) 0-2 points
* Lifetime is expected to more than 4 months
* Always anti-tumor treatment (including/radiation therapy, immune therapy, targeted therapy, endocrine therapy, etc.) to end more than 4 weeks (using the nitroso urea class and mitomycin chemotherapy drug withdrawal over 6 weeks), and always treat the adverse reaction of restored or stability

Exclusion Criteria:

* In the group treated with other experimental drugs within 4 weeks before, but in the intervening clinical research (except such as epidemiological studies)
* In group of four weeks before received the treatment of herpes simplex virus, such as acyclovir, ganciclovir, respectively.there is galloway, vidarabine, etc
* In group of four weeks before too much surgery
* Screening stage HSV - 1 antibody IgG and IgM are negative
A Drug Interaction Study of GDC-0032 Co-administered With Rifampin or Itraconazole in Healthy Volunteers

This open-label, two-arm, drug interaction study will investigate the effect of co-administration of rifampin or itraconazole on the pharmacokinetics of GDC-0032 in healthy volunteers. In Arm A, volunteers will receive GDC-0032 and rifampin; in Arm B, volunteers will receive GDC-0032 and itraconazole. The anticipated time on study treatment is approximately 30 days.


Eligibility Criteria:
Inclusion Criteria:

* Female volunteers will be non-pregnant, non-lactating, and either postmenopausal for at least 1 year or surgically sterile
* Male volunteers will either be sterile, or agree to use adequate methods of contraception
* Body mass index (BMI) range 18 to 32 kg/m2, inclusive
* No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs; and clinical laboratory evaluations
* Negative hepatitis B virus, hepatitis C virus and negative HIV antibody screens

Exclusion Criteria:

* Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
* History of stomach or intestinal surgery or resection that would alter absorption and/or excretion of orally administered study drugs
* History of alcoholism or drug addiction within 1 year prior to Check-in
* History of chronic proton pump inhibitor (PPI) use within 6 months of Check-in, or use of PPIs, H2-receptor antagonists, or antacids within 1 month prior to Check-in and during the entire study
* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
* History type 1 or 2 diabetes and/or elevated fasting glucose at baseline
* Malabsorption syndrome or other condition that would interfere with enteral absorption
* Use of any tobacco- or nicotine containing- products
* Participation in any other investigational study drug or biologic agent trial in which receipt of an investigational study drug occurred within 5 half-lives or 30 days, whichever is longer to Check-in and during the entire study duration