cyrilzakka/clinical-trials huggingface dataset:
Phase 2 Nab® -Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC)

This clinical study is in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. The study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of treatment. Subjects who complete the treatment will choose, with their treating physicians, what additional treatment should be given: more nab-Paclitaxel plus gemcitabine, Chemoradiation therapy, or surgery to treat the locally advanced pancreatic cancer.

This is an international, non-randomized, open-label, multi-center, Phase 2 study in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. All subjects will be treated with nab-paclitaxel plus gemcitabine for 6 cycles followed by an Investigator's Choice of continuation of treatment with nab-paclitaxel plus gemcitabine, chemoradiation therapy, or surgery.

Safety assessments by laboratory testing and physical exams will be conducted through-out the study.

Efficacy assessments by physical exam will be preformed through-out the study and tumor imaging will be conducted approximately every 2 months.

Subjects will be considered active study participants from enrollment up to, but not including, survival follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Non- metastasis, unresectable, adenocarcinoma pancreatic cancer patients
* No prior anticancer therapy for pancreatic cancer

  •≥ 18 years of age with a performance status of 0 or 1•Adequate complete blood counts, hepatic function, and renal function
* Signed informed Consent

Exclusion Criteria:

* Active bacterial, viral, or fungal infection
* Infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or receiving immunosuppressive or myelosuppressive
* Subjects with sensory neuropathy, ascites, or plastic biliary stent.
* Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders (including but not limited to connective tissue disorders, lung disease, and cardiac or seizure disorders)
* Women who are pregnant or breast feeding
Evaluation of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients

The purpose of this study is to evaluate the safety of an association with one anti-inflammatory and one gastroprotective agent compared to the one anti-inflammatory and one gastroprotective agent in patients with acute or chronic osteoarticular inflammation.

* Double-blind,randomized, multicenter
* Experiment duration: 14 days
* 03 visits
* Evaluate the safety of an association with one anti-inflammatory and one gastroprotective compared to association with one anti-inflammatory and one gastroprotective agent in patients with acute or chronic osteoarticular inflammation
* Adverse events evaluation

Eligibility Criteria:
Inclusion Criteria:

* Adults male or female aged ≥ 18 years old;
* Comply with all the purposes and procedures of the study by signing and dating the Informed Consent.
* Acute or chronic osteo-articular injury in need of of anti-inflammatory for a period of 14 days.

Exclusion Criteria:

* Pregnant women, or women in childbearing age who are not in use effective contraception or intending to become pregnant during the study period
* History of peptic ulcer or gastric surgery;
* Use of Non-steroidal anti-inflammatory (NSAIDs), aspirin, proton pump inhibitor (PPIs), H2 blocker and antacid in the past 7 days;
* Contraindication to the use of NSAIDs or PPIs;
* Renal or hepatic impairment;
Vitamin E in Preventing the Side Effects of Isotretinoin in Former and Current Smokers Who Are Receiving Isotretinoin to Prevent Lung Cancer

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of isotretinoin may be an effective way to prevent lung cancer. Vitamin E may prevent the side effects of isotretinoin therapy.

PURPOSE: Randomized clinical trial to study the effectiveness of vitamin E in preventing the side effects of isotretinoin in former and current smokers who are receiving isotretinoin to prevent lung cancer.

OBJECTIVES: I. Determine whether the addition of alpha-tocopherol (AT; vitamin E) to isotretinoin decreases the incidence of Grade II and higher toxicity of isotretinoin when administered to former and current smokers. II. Determine the compliance rate of isotretinoin of smoker and former smokers with or without AT over a six month period. III. Determine the feasibility of recruiting former and current smokers with or without AT over a six month period. IV. Determine the effect of isotretinoin administration on serum retinol and retinol-binding protein levels in these patients.

OUTLINE: This is randomized, placebo controlled study. Patients are stratified by smoking status (current smoker vs former smoker) and age (less than 50 vs 50 and over). Patients are randomized to be take alpha-tocopherol (AT) orally and isotretinoin orally daily (arm I) or isotretinoin orally plus AT placebo orally daily (arm II). Treatment in each arm continues for 6 months. Patients are followed at 1, 3, 6, and 7 months from start of treatment.

PROJECTED ACCRUAL: There will be 300 patients (150 per arm) accrued into this study over an estimated 9 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Current smokers with 20+ packs per year history of smoking OR Former smokers who discontinued smoking 1 year prior to registration (less than 5 cigarettes in the prior year) and had a 20+ packs per year history prior to discontinuing smoking

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 40 IU/mL OR SGPT less than IU/mL Renal: Not specified Other: Fasting triglycerides less than 320 mg/dL No prior malignancy in the past 5 years except nonmelanoma skin cancer or noninvasive cervical cancer No history of malabsorption syndrome Not pregnant Effective contraception required of all fertile persons

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior isotretinoin Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No prior warfarin or its derivatives At least 3 months since megadose vitamin A (greater than 25,000 IU/day) or beta-carotene greater than 30 mg/day or alpha-tocopherol at least 400 IU daily No concurrent megadose vitamin A (greater than 25,000 IU/day), beta-carotene greater than 30 mg/day, alpha-tocopherol at least 400 IU daily, or other daily supplements and tonics
STARS (Smoking Treatment And Remote Sampling) Study

This is a research study to find out if a smoking cessation medications, either varenicline or nicotine replacement products (patches or lozenges), are effective when given to smokers, remotely, as a one-time sample.

Participants will either receive a sample of varenicline, nicotine patches and lozenges, or neither. This will be decided randomly. Participants have a 50%chance of receiving varenicline, a 25% chance of receiving nicotine products, and a 25% chance of receiving neither. If the participant is assigned to a group that receives free samples, they will be mailed to them free of charge. There is no requirement to use them, and it is completely up to the participants. There is also no requirement to quit in this study.

The study lasts for six months, and will involve six total surveys. In addition, investigators ask that participants complete daily diaries (about 1 minute each) for the first 4 weeks of the study. Both varenicline and nicotine replacement products are well-established medications that help smokers quit.


Eligibility Criteria:
Eligibility criteria include:

1. age 18+;
2. daily smoker (25+ days per previous month);
3. smoking 5+ cigarettes/day;
4. smoking \> 1yr;
5. some interest in eventual quitting (\>2 on 10-point scale);
6. has a primary care doctor and has seen that doctor at least once in past year;
7. not currently pregnant, breastfeeding, or planning to become pregnant;
8. no suicidal ideation in past month, nor any lifetime suicide attempt;
9. no reports of hallucinations;
10. no reports of history of seizures; nor cardiac/renal disease
11. own a smartphone or have regular (daily) access/use of email
12. if female, willing to take a pregnancy test
13. not currently taking any medications to help quit smoking
14. no diagnosis of schizophrenia or bipolar disorder
15. no members of the same household currently enrolled in the study
A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome

To evaluate the safety and tolerability, treatment effect on abdominal pain, and dose response of MD-7246 administered orally to patients with diarrhea-predominant irritable bowel syndrome (IBS-D).


Eligibility Criteria:
Inclusion Criteria:

* Patient meets the Rome IV criteria for diagnosis of IBS-D
* Patient maintains a minimum level of compliance with daily diary
* Female patients of childbearing potential must agree to use one of the following methods of birth control:

  1. Hormonal contraception
  2. Double-barrier method
  3. Maintenance of a monogamous relationship with a male partner who has been surgically sterilized by vasectomy

Exclusion Criteria:

* Patient has clinically significant findings on a physical examination and/or clinical laboratory tests
* Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain
* Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
* Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments

NOTE: Additional inclusion/exclusion criteria may apply
The Effect of Exercise Training Programs: Step and Stability Ball on Balance and Obstacle Avoidance in Older People

Individuals of advanced age undergo both physical and cognitive deterioration. The aim of this study is to explore the effect of two types of physical activity on stability parameters.


Eligibility Criteria:
Inclusion Criteria:

* Age above 65
* Able to undergo physical activity for 45 minutes twice a week

Exclusion Criteria:

* All Others
Long-Term Immunogenicity Study of Inactivated EV71 Vaccine in Children

This study is designed to evaluate the long-term antibody titers of EV71 vaccine 4 and 5 years after first dose vaccination for subjects at the age of 2 to \< 6 years , and 3 to 5 years after first dose vaccination for subjects at the age of 2 months to \< 2 years

This is an extension study of protocol CT-EV-21, to evaluate the long-term immunogenicity of EV71vaccine.

The first study visit will be approximately 3 or 4 years after the administration of first vaccination of EV71 vaccine or placebo in CT-EV-21 study; 4 years after the first vaccination for subjects 2 to \< 6 years of age (2b), and 3 years after first dose for subjects 2 months to \< 2 years of age (2c and 2d).

Subjects of 2b will remain in the study for approximately 12 months and will have 2 clinic visits; subjects of 2c and 2d will remain in the study for approximately 24 months and will have 3 clinic visits. Immunogenicity response against EV71 virus antigen at each visit will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed participation in study CT-EV-21 part 2b, 2c, and 2d, and have received protocol specified doses of EV71 vaccine or Placebo (total of 2 doses in part 2b, and 3 doses for part 2c and 2d).
* The subjects' guardians are able to understand and sign the informed consent form.

Exclusion Criteria:

* Subjects and/or guardians who refuse to comply with the study procedures
Long-Term Followup and/or Thalidomide Maintenance Therapy for Patients Enrolled on Clinical Trial 20030165

The study seeks to provide long-term follow-up and/or to offer continued maintenance thalidomide (THALOMID) therapy to those patients enrolled in 20030165. Patients will be followed until withdrawal of consent, or death.


Eligibility Criteria:
Inclusion Criteria:

1. Enrolled on the 20030165 clinical trial.
2. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients who were discontinued from 20030165 for any reason prior to the completion of protocol-specified treatment (e.g. withdrawal of consent).
2. Uncontrolled, intercurrent serious illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and/or cardiac arrhythmia likely in the judgment of the PI to interfere with clinical study requirements.
3. Psychiatric illness/condition likely in the judgment of the PI to limit compliance with clinical study requirements.
A Study of Isoprinosine in Patients With Severe AIDS

To evaluate the effect of Isoprinosine in patients diagnosed as having AIDS relative to:

Laboratory (immunologic defects):

* Comparison of total helper and suppressor T-cell numbers among the groups.
* Comparison of changes in natural killer cell activity.
* Comparison of other laboratory findings among the groups.

Clinical changes:

* Comparison of the frequency of opportunistic infections among the groups.
* Comparison of the frequency of the development of AIDS-related malignancies.
* Comparison of other clinical manifestations relative to severity and time of onset.


Eligibility Criteria:
Exclusion Criteria

Co-existing Condition:

Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer are excluded.

Concurrent Medication:

Excluded:

* Steroids.
* Cytotoxic immunosuppressive agents.
* Radiotherapy.

The following are excluded:

* Critically ill patients.
* Patients receiving steroids, cytotoxic immunosuppressive agents, radiotherapy.
* Patients who have received any other immunotherapy.
* Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer.

Prior Medication:

Excluded:

* Any other immunotherapy.

Patients with severe AIDS and specified laboratory immunologic defects.
Post-Caesarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine

Study to compare between efficacy of post-caesarean section infiltration with lidocaine and epinephrine versus lidocaine only to reduce post-incisional pain.

assessment of adding of epinephrine to lidocaine as local infiltrator to post-caesarean section wound in prolongation of its anaesthetic effect.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing caesarean delivery under General anesthesia for various indications.
* Women refuse spinal anesthesia.

Exclusion Criteria:

* Known or suspected sensitivity to local anesthesia.
* Medical disorders induced by pregnancy (Pre-eclamptic toxemia, gestational diabetes mellitus, Hepatic diseases, homeostatic disorder)
* Medical disorders aggravated by pregnancy (cardiovascular disease, pulmonary disease, renal disease, neurological disease, metabolic or infectious diseases).
* Women who hemo-dynamically unstable.
* Lack of adequate verbal communication.
Safety and Antiviral Activity Study of Clevudine 30 mg QD in Patient With Chronic HBV

The purpose of this study is to determine safety and efficacy of 30 mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in patients with chronic HBV.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who were between 18 and 60, inclusive.
2. Patients with HBV DNA ³1 x 106 copies/mL within 30 days of baseline.
3. Patients who were documented to be HBsAg positive for \> 6 months. (The documentation of positive HBsAg for the previous 6 months included previous laboratory reports of HBsAg positive or HBeAg positive at least 6 month ago or IgM anti-HBc negative and IgG anti-HBc positive at screening).
4. Patients who were HBeAg positive.
5. Patients with ALT levels which were in the range of ≥1.2 and \< 15 times of the upper limit of normal (x ULN) and bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), and a serum albumin level of at least 3.5 g/dL.
6. Women of child bearing potential with a negative serum (β-HCG) pregnancy test taken within 14 days of starting therapy.
7. Patients who were able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.
2. Patients previously treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection.
3. Previous treatment with interferon that had ended less than 6 months prior to the screening visit.
4. Patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.
5. Patients co-infected with HCV, HDV or HIV.
6. Patients with clinical evidence of liver mass or with alpha-fetoprotein \> 50 ng/mL
7. Patients who were pregnant or breast-feeding.
8. Patients who were unwilling to use an "effective" method of contraception during the treatment and for up to 3 months after cessation of therapy. For males, condoms should be used. Females had to be surgically sterile (via hysterectomy or bilateral tubal ligation) or post-menopausal or using at least medically acceptable barrier method of contraception ( i.e. IUD, barrier methods with spermicide or abstinence)
9. Patients with a clinically relevant history of abuse of alcohol or drugs.
10. Patients with a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, biliary diseases except asymptomatic GB stone, neurological, cardiovascular, oncologic or allergic disease.

    The patients with a benign tumor were excluded if judged by an investigator that the continuation of study would be interfered by benign tumor.
11. Patients with creatinine clearance less than 60mL/min as estimated by the following formula :

(140-age in years) (body weight \[kg\]) (72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]

Patients who were found to have YMDD HBV DNA polymerase mutation at baseline were to be excluded from the overall efficacy evaluation and analyzed separately. They were to be included in the overall safety evaluation.
Perioperative Fluid Therapy Optimization in Spinal Surgery

The decision to give fluids perioperatively could be based on methods used to identify preload responsiveness, either invasive or noninvasive estimates of stroke volume variation during mechanical ventilation. This study compares fluid management using continuous noninvasive cardiac output measurement with standard perioperative fluid management.

The aim of the study is to optimise fluid managemet and to reduce perioperative risks during spinal procedures in prone position. Adequate perioperative management guided by hemodynamic monitoring can help to reduce the risk of complications and thus potentially improve outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Glasgow Coma scale 15
* ASA Physical Status Classification System I-III
* planed spinal surgery to 3 hours
* postoperative awakening
* sinus rhythm

Exclusion Criteria:

* NYHA III, IV
* BMI over 40 in females and over 35 in men
* awake operation
* postoperative artificial ventilation
Predictors of Difficult Videolaryngoscopy

The primary goal of this study was to identify parameters affecting the failure of videolaryngoscopy in clinical practice; secondly, the incidence of videolaryngoscopy use and the most frequently used patient groups.

Videolaryngoscopy is widely used in the management of patients with presumed difficult airway. It offers an improved laryngeal view compared with direct laryngoscopy and increases the likelihood of successful intubation in patients for whom direct laryngoscopy is anticipated to be difficult. It is among the most frequently preferred difficult airway devices due to its ease of use, portability and direct laryngoscopy resemblance. The use of videolaryngoscopy has been shown to improve intubation success in many cases associated with difficult intubation, such as morbid obesity, pregnancy, limitation of cervical motility, and poor mouth opening.

Eligibility Criteria:
Inclusion Criteria:

* All patients who used videolaryngoscopy for intubation

Exclusion Criteria:

-
Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase I trial to determine the effectiveness of genistein in treating patients who have stage II, stage III, or stage IV prostate cancer.

OBJECTIVES: I. Determine the safety and pharmacokinetics of genistein in patients with stage II, III, or IV prostate cancer.

OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral genistein twice daily. Arm II: Patients receive oral placebo twice daily. Treatment continues for 3 months in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 6 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed stage B, C, or D adenocarcinoma of the prostate not amenable to surgery

PATIENT CHARACTERISTICS: Age: 40 and over Performance status: ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Transaminases less than 4 times upper limit of normal Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease Other: No significant abnormalities of internal organs, neurologic status, or biochemical levels No history of seizures No concurrent serious illness No acute infection requiring antibiotic therapy except chronic urinary tract infection No other prior or concurrent malignancy within the past 2 years except nonmelanoma carcinoma of the skin No history of substance abuse or addiction No alcohol intake greater than 2 drinks/day or 14 drinks/week No diet containing more than 20 mg of genistein/day No known soy intolerance No prior breast cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: At least 3 months since prior hormonal therapy OR No concurrent estrogen Other concurrent hormonal therapy allowed if stable regimen for more than 3 months Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics At least 3 weeks since prior surgery and recovered Other: At least 6 weeks since prior antibiotics No concurrent genotoxicity therapy
Non-invasive Brain Stimulation for Auditory Verbal Hallucinations in Schizophrenia

The current study investigates the basic principles that underlie the efficacy of transcranial direct current stimulation for chronic auditory verbal hallucinations in schizophrenia in a multimodal design.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of schizophrenia
* chronic auditory verbal hallucinations
* right-handed

Exclusion Criteria:

* drug abuse other than nicotine
* severe cognitive deficits
* severe medical conditions
* severe neurological disorders
* severe microangiopathy
* history of electroconvulsive therapy
* pregnancy or lactation