cyrilzakka/clinical-trials huggingface dataset:
mFOLFOX6 Chemotherapy With Apatinib as Postoperative Treatment in Stage IIIB or IIIC Colorectal Cancer

This study will focus on postoperative patients of stage IIIB or stage IIIC colorectal cancer. These patients will start to accept chemotherapy in 3-4 weeks after operation, these patients were randomly divided into two groups, one group will accept adjuvant chemotherapy of mFOLFOX6; another group will use mFOLFOX6 combined with apatinib. The efficacy and safety of adjuvant chemotherapy will be compared between the two groups. Disease-free survival, overall survival, incidence of adverse reaction of chemotherapy and postoperative quality of life will be recorded.


Eligibility Criteria:
Inclusion Criteria:

1. signed informed consent form;
2. confirmed as colorectal cancer by pathology, and the stage is IIIB /IIIC according to the NCCN guidelines;
3. patients with primary colorectal cancer;
4. radical resection of colon cancer (CME) or radical resection of rectal cancer (TME) has done;
5. 3\~4 weeks after radical resection ;
6. patients did not receive any radiotherapy and chemotherapy before operation

Exclusion Criteria:

1. emergency operation for colorectal cancer patients;
2. the situation after operation can not tolerance for systemic adjuvant chemotherapy (hemoglobin \<95g/L, white blood cell \<3 \* 109/L, granulocyte \<1.5 \* 109/L and platelet \<75 \* 109/L, bilirubin\>2.5N, alanine aminotransferase \>2.5N, alkaline phosphatase \>2.5N, urea nitrogen \>2.5N, creatinine \>2.5N, proteinuria, hematuria, temperature of \>38 degree);
3. serious diseases such as cardiac insufficiency, respiratory insufficiency, liver and kidney dysfunction, serious blood diseases;
4. patients participated in other clinical trials at the same time;
5. pregnant or perinatal women;
6. combined with other malignant tumors;
7. a history of neuropsychiatric disorders;
8. patients have used anti angiogenesis targeted drugs (such as bevacizumab, cetuximab);
9. patients had a history of severe trauma within 4 weeks before admission;
10. allergic to chemotherapy drugs or apatinib;
11. active bleeding, ulcers, intestinal perforation, intestinal obstruction, hypertension
Fasting Study of Liothyronine Sodium Tablets (50 Mcg) to Cytomel® Tablets (50 Mcg)

The objective of this study was to investigate the bioequivalence of Mylan's liothyronine sodium 50 mcg tablets to King's Cytomel® 50 mcg tablets following a single, oral 100 mcg (2 x 50 mcg) dose administration under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* healthy males and/or non-pregnant, non-lactating females, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days prior to start of study
* received any investigational products within 30 days prior to start of study
Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis

The purpose of this study is to determine whether miltefosine is effective in the treatment of mucosal leishmaniasis compared to meglumine antimoniate, the standard treatment.

Mucosal leishmaniasis is a rare form of the disease, that affects only 6% of the patients with cutaneous leishmaniasis in the New World. It causes deformities and may be lethal if not treated. It is part of the neglected tropical diseases because on the past sixty years there was few progress regarding other treatment options or improvement at quality of life of its patients. Also, there was little interest from the pharmaceutical industry and government authorities to develop new researches. The standard treatment, meglumine antimoniate, is toxic, invasive, requires trained personnel and has many adverse effects and restrictions. On the other hand, miltefosine is the first oral drug to demonstrate efficacy against mucocutaneous leishmaniasis. Few clinical trials have being performed in Central and South American countries, but so far, just one involved mucosal leishmaniasis patients, and compared miltefosine to amphotericin B. None studies comparing its efficacy to the standard treatment have being done.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of mucosal leishmaniasis
* Not previously treated, or last treatment must have occurred more than 6 months before the enrollment on the study
* Use of contraceptive method, if female on child bearing age
* Sign the agreement and consent form

Exclusion Criteria:

* Previous leishmanicidal treatment on the past 6 months before the enrollment on the study
* Electrocardiogram abnormalities on the pretreatment exams
* Previous kidney, liver and/or heart diseases
* Diabetes Mellitus
* Hypersensitivity to miltefosine or meglumine antimoniate
* Pregnant women or breastfeeding mothers
* Hiv patients
SP Resistance and Falciparum Malaria Transmission

The purpose of this study is to study resistance to current malaria treatments and affordable alternatives for uncomplicated malaria. Resistance occurs in areas where these treatments are used frequently. This study may help prevent future resistance. About 150 residents in Buenaventura, Colombia will participate. They will have uncomplicated malaria and they will be followed for 28 days after treatment. Physical exams and blood draws are included in study visits.

Drug-resistant Plasmodium falciparum is a major threat to global public health and new strategies are needed to deter spread of resistance to available and forthcoming antimalarial drugs. This study seeks to contribute to understanding the molecular basis of spread of drug resistance in a setting with low level of sulfadoxine-pyrimethamine (SP) treatment failure. The objectives of this study are to compare the prevalence of dihydrofolate reductase (DHFR) and dihydropteroate synthase (DHPS) point mutations associated with SP resistance before and after SP treatment of uncomplicated Plasmodium falciparum malaria episodes and to measure parasite infectivity to Anopheles mosquitoes of post-treatment gametocytes with and without DHFR and DHPR mutations. Patients with uncomplicated falciparum malaria will receive a standard SP regimen and will be closely followed for 28 days. This study will add new knowledge of the understanding of ways in which resistance is spread and is expected to provide a sound basis for the future clinical evaluation of antimalarial drug combinations designed to prevent transmission of drug-resistance malaria.

Eligibility Criteria:
Inclusion Criteria:

Age more than 5 years Positive blood smear for falciparum malaria Informed consent from participant or parent Intention to remain in the study area for at least 4 weeks from the time of enrollment

Exclusion Criteria:

Mixed Plasmodium infection Parasitemia \> 10% Hematocrit \< 15% Respiratory distress Spontaneous bleeding (from gums, nose, gastrointestinal tract, etc.) Recent seizures or coma Prostration or weakness, so that the patient cannot sit or walk, with no obvious neurological explanation Inability to drink Persistent vomiting History of allergy or adverse reaction to sulfadoxine-pyrimethamine (SP) or sulfa drugs Known pregnancy
To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated Tablets Under Non-Fasting Conditions

To demonstrate the relative bioavailability of Diclofenac Sodium 50 mg enteric-coated tablets under non-fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Expanded Access for Marizomib

This is an expanded access program (EAP) for eligible participants designed to provide access to Marizomib.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Assessment of LTP-like Pain Amplification in Chronic Low Back Pain Patients

The present study is aimed to assess the LTP-like pain amplification in chronic low back pain patients to explore the central and peripheral effect for pain LTP.

This study is a cross-sectional study. Two groups, including low back pain group and healthy subjects group will be arranged in this study. 50 subjects will be recruited in each group, The healthy subjects were matched for sex and age in relation to the low back pain group. Conditioning electrical stimulation (100 Hz, repeated 5 times with 10 s intervals, 500 impulses) using circular pin electrodes will be used in both groups to induce LTP-like pain amplification. The pain intensity changes to pinprick and light touch stimuli will be compared between two groups.

Eligibility Criteria:
1. Chronic low back pain patients

   Inclusion Criteria:
   * Age 21-80 years old.
   * People must have experienced low back pain for at least 3 months and have reported a minimal pain level of 30 (pain threshold) on the 0-100 pain numerical rating scale (NRS) in the last 7 days.

   Exclusion Criteria:
   * Age below 21 or over 80 years old.
   * Patients were excluded if they had taken pain medications on the day of the assessment or if they had serious spinal pathologies, such as fractures, tumors or inflammatory diseases, such as ankylosing spondylitis, nerve root compromise confirmed by clinical neurological tests or severe cardiorespiratory diseases. Those who were pregnant, patients with cancer and those with a cardiac pacemaker were also excluded.
2. Healthy volunteers.

Inclusion Criteria:

* Age 21-80 years old.
* These participants must not have presented episodes of low back pain for more than 7 days in the last 12 months.

Exclusion Criteria:

* Age below 21 or over 80 years old.
* These participants have presented episodes of low back pain for more than 7 days in the last 12 months.
Pilot Study With GFT505 (80mg) in Patients With Insulin Resistance and Abdominal Obesity

The purpose of this study is to demonstrate the efficacy on insulin sensitivity of GFT505 at 80mg/d in male patients with insulin resistance and abdominal obesity. Evaluation will be made using a glucose clamp technique.

The study period per patient is 26 weeks: a selection period will precede a 8-week treatment period, a 6-week wash out period, a second 8-week treatment period in the second arm of treatment and a 2- week follow-up period.

Schedule:

* Selection visit prior to treatment period (D-14 and D-1)
* D0 : randomisation visit
* Period T1: first period of treatment with GFT505 80mg or placebo for 8 weeks (D1 to D56)
* Wash out period for 6 weeks (D57 to D98)
* Period T2: second period of treatment with GFT505 80mg or placebo for 8 weeks (D99 to D154)
* Follow up period for 2 weeks (D155 to D169)

Eligibility Criteria:
Inclusion Criteria:

* Waist circumference ≥94cm.
* Body Mass Index ≤ 45kg/m2.
* Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) \> 3.

Exclusion Criteria:

* Blood Pressure \> 160 / 95 mmHg.
* Diabetes mellitus 1 or 2.
* Historical of bariatric surgery.
* Patient treated with a lipid-decreasing medication.
* A fasting plasma triglycerides concentration \> 400mg/dL or a plasma Low Density Lipoprotein Cholesterol (LDL-c)concentration \> 220mg/dL.
Korean CRC Screening Study PT13599

Korean Americans report the lowest and declined rates of colorectal cancer (CRC) screening, compared to general population in the United States. The present study aimed to evaluate the efficacy of a community-based multifaceted intervention designed to improve CRC screening among Korean Americans.


Eligibility Criteria:
Inclusion Criteria:

* Participants were eligible to participate in this study if they:

  1. were self-identified Korean Americans;
  2. were 50 years and older;
  3. did not have a colorectal polyp, CRC cancer, or a family history of CRC (first degree relative); and
  4. non-adherent to CRC screening guidelines (never had any CRC screening or were overdue for screening).

     Exclusion Criteria:
Genetic Study of Familial Acute Lymphoblastic Leukemia

Familial aggregation is well recognized in some cancers. Though a number of familial cancer predisposition syndromes have been described, the nature of inherited genetic alterations in patients with a strong history of familial cancer is currently unknown, as is the case with childhood acute lymphoblastic leukemia (ALL).

The investigators are seeking to learn more about what causes leukemia and why some people and families may be at a higher risk of developing this disease. By understanding the origin of the disease, better treatments may be identified for patients with leukemia.

PRIMARY OBJECTIVE: To identify variants in genes that are inherited, have altered gene structure and/or function, and influence the risk of developing acute lymphoblastic leukemia (ALL) and other cancers.

SECONDARY OBJECTIVE: To collect demographic, clinical and laboratory information including detailed family cancer history and response of cancers to therapy for correlation with the primary objective.

This study entails clinical interviews, submission of a peripheral germline blood sample for non-tumor DNA and permission to perform biologic studies on previously stored tumor tissue if applicable and available. Participants diagnosed with cancer at outside institutions will be requested to sign a release form to allow the outside institution to send germline and/or tumor tissue to St Jude if available. For patients who have undergone a stem cell transplant, a buccal swab or saliva sample will be requested (for germline DNA). For patients with active leukemia, non-tumor cells (for germline DNA) may be obtained using a remission blood sample, a skin biopsy (to obtain fibroblasts) or may be purified by fluorescence activated cell sorting of leukemia samples. The skin biopsy will be obtained in participants 18 years of age and older. In participants less than 18 years, the skin biopsy will be accessed only if it was already collected as part of another research protocol or for clinical care.

All patients being considered for enrollment will have a clinical genetics consult by one of the study team members at which time a family history will be taken and information about genomic testing will be introduced. Detailed medical history will be obtained which includes but is not limited to demographics, clinical data including laboratory results, cancer history/diagnosis, treatment outcomes, environmental exposures and cancer risk factors to enable phenotype/genotype correlations.

Eligibility Criteria:
Inclusion Criteria:

* Patient with acute lymphoblastic leukemia (ALL) and has a relative also diagnosed with ALL. Note: There is no upper age limit, and the index ALL case does not have to be a patient diagnosed and/or treated at St. Jude.
* Family members of the patient, either affected or unaffected by a malignancy, who are contacted by the patient (or guardian) and agree to participate in the study. Relatives may have been diagnosed with other malignant, genetic or developmental disorders.
* Research participant or legal guardian, as appropriate, must provide informed consent for this protocol.
The Effect of Turmeric on New Onset Primary Dysmenorrhea

The study was planned as 150 patients. Patients who met early-onset dysmenorrhea criteria and who met the inclusion criteria; 150 patients were divided into 2 equal groups, and NSAID during the menstrual cycle, nsai + turmeric 1 gr oral powder form treatment was planned to be started in the other group. The pain frequency and severity before and after treatment were evaluated by visual analog scale and the two groups were compared.

There are scientific publications on the use of turmeric, which constitutes the hypothesis of our study, in branches such as cardiology, neurology, infertility and chest diseases due to its anti-inflammatory, anti-aging properties.

The data are planned to be evaluated by the researchers using the SPSS(Statistical Package for the Social Sciences ) 17.0 program on computer. The responses of all groups to the VAS scores are planned to be entered into the system by using the SPSS program before and after treatment. statistics (number, percentage, mean, standard deviation), chi-square and logistic regression analysis are used to compare categorical variables. Chi-square test and Mann Whitney-U test are planned to be used in comparison between groups.When examining the difference between the groups, if the p value is less than 0.05, it is planned as a proof of significant difference.

Eligibility Criteria:
Inclusion Criteria:

1. Early-onset primary dysmenorrhea (Definition: Pain that begins in less than 6 months, is not accompanied by infection, begins on the first day of menstruation and ends on the last day of menstruation)
2. Non-pregnant and breastfeeding patients
3. Between 16-35 years old
4. No anatomic pathology or disease
5. Lack of active infection
6. No history of drug use
7. BMI is less than 25
8. Those who wish to participate in the study signed the consent form
9. Smoking, non-alcoholic patients
10. Patients who completed their treatment and came to the control
11. Regular menstruation

Exclusion Criteria:

1. Presence of vaginal infection such as Trichomonas vaginalis and candida albicans
2. Patients who do not want to participate in the study
3. Pregnant and nursing patients
4. Be under 16 years or older than 30 years
5. Systemic disease
6. Smoking, alcohol consumption
7. BMI higher than 25
8. People with organic pelvic pathology (ovarian cyst, fibroids, polyps)
9. People with a history of drug use
10. Patients who discontinue treatment and do not come to control
11. Irregular menstruation
12. Any history of contraindication to naproxen
13. Turmeric allergy history
AZD8683 Multiple Dose Study in Healthy Volunteers and Chronic Obstructive Pulmonary Disease (COPD) Patients

This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending inhaled doses of AZD8683 in Healthy volunteers and repeated inhalation of one dose level of AZD8683 in patients with chronic obstructive pulmonary disease given once daily.

A Phase I, Single Centre, Double-Blind, Randomised, Placebo- controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Inhaled Doses of AZD8683 in Healthy Volunteers and COPD patients

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers and healthy female volunteers of non-child bearing potential, aged 18 to 45 years inclusive with suitable veins for cannulation or repeated venepuncture - Healthy volunteers
* Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg inclusive - Healthy volunteers and COPD patients
* Be able to inhale from the Turbuhaler® inhaler according to given instructions as well as be able to perform spirometry -Healthy volunteers and COPD patients.
* Male COPD patients or female COPD patients of non-childbearing potential (post menopausal or surgically sterilised) aged ≥40 years at Visit 1 - COPD patients
* Female healthy volunteers and female patients ≤60 years must have a negative pregnancy test at screening and on admission to the unit - Healthy volunteers and COPD patients

Exclusion Criteria:

* Prolonged QTcF \>450 ms or shortened QTcF \<340 ms or family history of long QT syndrome - Healthy volunteers and COPD patients
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD8683 or excipients:Healthy volunteers and COPD patients
* History or presence of gastrointestinal, pulmonary, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs - Healthy volunteers and COPD patients
* Any clinically significant illness (other than COPD), medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product - COPD patients
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product - Healthy volunteers
Palatability of Experimental Cigarettes - Study 2

Smoking remains a leading cause of preventable disease and premature death worldwide. Approximately 1 out of every 5 deaths is associated with cigarette smoking, and roughly half of all daily smokers will die prematurely from tobacco-related illness. Reducing the nicotine in cigarettes to the point that they are rendered non-addictive can potentially be an effective public policy measure that can significantly reduce tobacco-related mortality and morbidity by decreasing the initiation of smoking and promoting cessation. The Family Smoking Prevention and Tobacco Control Act (FSPTCA) enables the FDA to establish tobacco product standards including placing limits on the allowable nicotine content of cigarettes. Currently, no reduced nicotine cigarettes are available that will allow studying the feasibility of this policy measure. The National Institute on Drug Abuse has contracted with Research Triangle Institute to assist in the development of cigarettes with varying nicotine content that can be made available to researchers. They have established a contract that will result in the manufacture of 9 million cigarettes to be distributed to the research community. Prior to full production, the palatability and nicotine intake of these cigarettes in smokers must be determined.

Phase 3: This descriptive study will use a between subjects, double blind design. This study will test 3 nicotine levels of nicotine, tar and ventilation. Subjects and research assistants will be blind to the cigarette type.

Eligibility Criteria:
Inclusion Criteria:

* 18-64 years old
* Regular smokers (10+ cigarettes per day and has done so for the last year)
* Inhaling when smoking
* Carbon monoxide (CO) \> 8 ppm

Exclusion Criteria:

* In the past year, suffered from any cardiovascular disease such as: heart disease, heart attack, stroke or angina, any respiratory diseases such as chronic bronchitis or chronic obstructive pulmonary disease (COPD), any type of cancer
* Currently suffering from Bipolar Disorder, General Anxiety Disorder, Schizophrenia, or a major depressive episode
* Taken any of the following drugs more than twice per week during the past month: antidepressants, anti-anxiety medications.
* Consumed more than 15 alcoholic drinks per week for the past month
* Pregnant, trying to become pregnant, or lactating (assessed by self-report)
* In the past 3 months, used nicotine replacement products (like the patch, gum, or inhaler), or the medications bupropion varenicline
* Currently trying or planning to reduce or quit tobacco use in the next 30 days
* Used other forms of tobacco 10 or more days in the past 30 days