cyrilzakka/clinical-trials huggingface dataset:
A Lot-to-Lot Consistency Study to Evaluate Safety, Tolerability, and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Healthy Adults (V212-014)

The study will evaluate the consistency of 3 lots of inactivated VZV vaccine for safety, tolerability, and immunogenicity in healthy adults. The primary hypothesis of the study is that the 3 lots of inactivated vaccine will demonstrate similar immunogenicity at 28 days after the fourth dose.


Eligibility Criteria:
Inclusion Criteria:

* Afebrile (\<=100.4 °F \[\<=38.0 °C\]) oral or equivalent on Day 1 before the first vaccination
* Any underlying chronic illness that is not in stable condition
* History of varicella, antibodies to VZV, or residence (for \>=30 years) in a country with endemic VZV infection
* Female participants of childbearing potential must have a negative pregnancy test. A female not of reproductive potential has reached natural menopause, or is 6-weeks postsurgical bilateral oophorectomy and/or hysterectomy or bilateral tubal ligation
* Male, or female of childbearing potential who agrees to remain abstinent or use 2 acceptable methods of birth control from 2 weeks before enrollment to 6 months after the last study vaccination

Exclusion Criteria:

* History of allergic reaction to any vaccine component, or an anaphylactic/anaphylactoid reaction to neomycin (not including contact dermatitis to neomycin)
* Prior history of herpes zoster
* History of receipt or expects to receive any varicella or zoster vaccine during the study period
* Is pregnant or breastfeeding, or expects to conceive from 2 weeks before enrollment to 6 months after the last study vaccination
* Has received a live virus vaccine or is scheduled to receive any live virus vaccine from 4 weeks before the first dose of study vaccination and throughout the study
* Has received any inactivated vaccine or is scheduled to receive any inactivated vaccine from 7 days before to 7 days after any study vaccination
* Received immunoglobulin or any blood products or is scheduled to receive them from 5 months before the first dose of study vaccination and throughout the study
* Has participated in an investigational drug or vaccine study within 30 days before enrollment
* Has any acute illness or significant underlying illness that may interfere with interpretation of the study
* Receiving immunosuppressive therapy (including systemic corticosteroid doses exceeding physiological replacement doses within 14 days prior to the first vaccination), except topical, ophthalmic, or inhaled corticosteroids or intra-articular or soft-tissue injections of steroids
* Has known or suspected immune dysfunction
Randomized Phase II Study of Epirubicin vs Caelyx in Pretreated Metastatic Breast Cancer

DOXORUBICIN is recognized as one of the most active drugs for breast cancer, but its clinical utility is limited because of a cumulative dose-dependent cardiac myopathy that can lead to potentially fatal congestive heart failure. Caelyx (pegylated liposomal doxorubicin) was designed to reduce the cardiotoxicity of doxorubicin while preserving its antitumor efficacy

To compare the efficacy of pegylated liposomal doxorubicin versus epirubicin as second line chemotherapy in patient with advanced breast cancer

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate bone marrow function (Absolute neutrophil count \>1000/mm\^3, Platelet count\>100000/mm\^3, Hemoglobin\>9gr/mm\^3)
* Histologically- or cytologically- confirmed breast adenocarcinoma
* No prior anthracycline-based chemotherapy as treatment of advanced breast cancer
* No prior chemotherapy with ≥ 300mg/m2 doxorubicin or ≥ 540mg/m2 epirubicin as adjuvant setting
* At least 4 weeks interval since prior anticancer treatment
* Measurable disease as defined by the presence of at least one measurable lesion(except bone metastases, ascites or pleural effusions)
* Life expectancy \> 3 months
* Written informed consent

Exclusion Criteria:

* Pregnancy or nursing
* Documented history of congestive heart failure (CHF), serious arrhythmia, or myocardial infarction (within 6 months)
* Other invasive malignancy except nonmelanoma skin cancer or acute infection.
* Radiation of measurable disease (except brain metastases)
* Progressive brain metastases according to clinical or radiological criteria.
* Brain metastases without prior radiation therapy
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder in PLWH

The purpose of this study is to learn more about how accelerated theta burst stimulation affects methamphetamine craving and brain activity. Theta burst stimulation is a unique transcranial magnetic stimulation (TMS) paradigm that is efficient and potent.

The investigators will compare how two theta burst paradigms, intermittent theta burst stimulation (iTBS) and continuous theta burst stimulation (cTBS), compare with sham TMS in changing methamphetamine craving and brain activity. iTBS, cTBS, and sham TMS will be delivered in an accelerated fashion (two sessions daily, separated by 50 minutes). iTBS will be delivered to the left dorsolateral prefrontal cortex (left dorsolateral prefrontal cortex), and cTBS will be delivered to the frontal pole. A brain MRI scan will be done before and after the iTBS/cTBS/sham TMS sessions. The study involves four visits. Each visit will last three hours. Hence, participants will spend a total of 12 hours in the study.

Eligibility Criteria:
Inclusion Criteria:

* Adults in the age group 18-65 years
* Able to read and understand English
* Able to provide informed consent
* Diagnosed with HIV
* History of current or previous Methamphetamine Use Disorder
* Endorse craving for methamphetamine
* Demonstrate an attentional bias for methamphetamine

Exclusion Criteria:

* Traumatic brain injury
* h/o seizure disorder
* h/o or current diagnosis of schizophrenia
* intracranial metal shrapnel
* previous adverse effects with TMS
* sub-threshold consistency while performing behavioral tasks
* lack of attentional bias to methamphetamine cues
* a positive pregnancy test for female participants
De Quervain Syndrome Among Medical Students with Smart Phone Addiction

To investigate the prevelance of the de quervain tenosynovitis among the Egyptian medical students with smartphone addiction

Addictive participants will be assigned and enrolled in the study according to there addiction score on smartphone addiction scale.

Participants will receive a Finkelstein test for both dominant and non dominant hand for the de quervain tenosynovitis.

Then the strentgh of both hand grip and pinch grip for both hands will be tested using hand grip strength dynamometer and pinch strentgh dynamometer.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic students with normal healthy state
* Any student in all the academic years with age 18-25
* Addictive smart phone users with score over 31 for male and 33 for female students in smart phone addiction scale.
* Who own or use mobile.
* Both genders: male and female
* Willing to participate.
* Egyptian students

Exclusion Criteria:

* Those who don't have mobile phone.
* Any previous injury or trauma or surgery and a history of rheumatoid arthritis, osteoarthritis, and deformities and changes in the shape of the finger joints.
* Those who are not willing to participate.
* Non-Egyptian students.
Hypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Bronchiectasis

The investigators hypothesise that nebulised hypertonic saline (6%) will increase the volume of sputum expectorated over a 24 hour period compared to nebulised isotonic saline (0.9%) in patients with mild to severe stable bronchiectasis.


Eligibility Criteria:
Inclusion Criteria:

* Non CF Bronchiectasis
* 18-80 years
* FEV1 less than 90%
* Chronic sputum production
* Clinical stable

Exclusion Criteria:

* Intolerance to HTS
* Use of HTSaline or antibiotics 14 days prior to study
* Clinically unstable
* Smokers
A Pilot Evaluation of the Impact of Alcohol Use on Airway Inflammation and Mechanics in Asthmatics

Since 1980, the number of people in the United States diagnosed with asthma has increased dramatically. Studying what causes and triggers asthma is an important part of understanding and subsequently managing this disease. Although some have suggested that alcohol consumption may affect asthma, little is known about how consistent alcohol use affects the amount of inflammation present in the lungs and whether consistent alcohol use makes the airways more narrow and stiff.

Participation in this study involves 2 visits in order to complete questionnaires, various pulmonary function tests, as well as the collection of blood, urine, and exhaled breath condensate specimens.

This study includes optional genetic and bronchoscopy substudies.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years of age
* Literate in English (i.e., read study materials at 6th grade level) so as to understand, and complete the ratings scales and questionnaires accurately
* Physician-diagnosed asthma requiring treatment in the past year with a post bronchodilator FEV1/FVC \>0.70 and at least 12% reversibility after bronchodilator usage
* Alcohol usage groups: 1) those who rarely or who do not drink alcohol (≤2 drinks per month); or 2) those who drink 3 or more alcoholic beverages per day on average

Exclusion Criteria:

* Social drinkers (\>2 drinks in a month but \<3 drinks per day)
* Asthma exacerbation within the past month
* Current upper respiratory infection
* Active allergies with uncontrolled symptoms
* Current DSM-IV diagnosis of illicit substance dependence (not alcohol)
* History of serious pulmonary problems other than asthma
* Other significant non-pulmonary comorbidities
* Pregnancy or currently lactating
* Daily use of Prednisone or other corticosteroids
* Tobacco smoking within the past year or \>10 life-time pack-years of smoking
* Positive breath alcohol level at the time of the study assessments
* Positive urine cotinine test at enrollment (indicates nicotine usage)
Effects of Labetalol on Nicotine Administration in Humans - 14

The purpose of this study is to investigate the effects of labetalol in response to intravenous nicotine

The purpose of this study is to determine whether labetalol, an alpha and beta adrenergic blocker, will block the subjective and physiological effects of intravenously administered nicotine in humans. A total of 12 subjects will participate in the double blind placebo controlled, outpatient study. Subjects will have 3 separate experimental sessions 3-9 days apart. On each of the experimental sessions, a single oral dose of low (100mg) or high dose of labetalol (200mg ), or placebo will be administered. Two hours after labetalol or placebo treatment, subjects will receive 15 variance grams nicotine base/kg intravenously. Several physiological endocrine and subjective measures will be obtained during the sessions. We propose that blockage of adrenergic receptors by labetalol will significantly block the physological and subjective effects of nicotine.

Eligibility Criteria:
Inclusion Criteria:

Male/Female, aged 21-55 years with a smoking history of at least 1 pack of cigarettes daily for at least 1 year. In good health as verified by medical history, screening examination, and screening laboratory tests.

Exclusion Criteria:

History of heart disease, peripheral vascular disease, COPD, any other medical condition which physician investigator deems inappropriate for subject participation. Pregnant or lactating or not using adequate birth control methods. Use of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics and recent psychiatric history). Chronic use of systemic steroids or antihistamines. Abuse of alcohol or any other recreational or prescription drug. Regular use of any other tobacco products, including smokeless tobacco and nicotine products.
First-time Fathers' Experiences of Childbirth in Lorraine

The primary aim of this study is to evaluate first time father's experience during childbirth in three different maternity hospitals in Lorraine.

Secondary aims of this study is to identify domains that need improvement in order to enhance fathers's experience during childbirth.


Eligibility Criteria:
Inclusion Criteria:

* First time father after a physiological pregnancy and delivery of a healthy newborn of more than 37 gestational weeks.

Exclusion Criteria:

-
Study on Lymphocyte Subsets of Peripheral Blood in Patients With Nonmyopathic Dermatomyositis Complicated With Pulmonary Interstitial Disease

To detect the changes of lymphocyte subsets in peripheral blood of non-myopathic dermatomyositis with pulmonary interstitial disease, classical dermatomyositis with pulmonary interstitial disease, rheumatism with non-inflammatory myopathy with pulmonary interstitial disease and healthy adults among the 4 groups, and to detect the related cytokines secreted by lymphocyte subsets Th1,Th2 and Th17. Clinical features, distribution of peripheral lymphocyte subsets ratio and related cytokine content secreted by each lymphocyte subset were analyzed in each group, so as to explore the pathogenesis characteristics of nonmyopathic dermatomyositis complicated with pulmonary interstitial disease, in order to facilitate clinical guidance for diagnosis and treatment.


Eligibility Criteria:
Inclusion Criteria:

1. The experimental group met the diagnostic criteria of Sontheimer and was diagnosed as CADM with pulmonary interstitial disease.
2. Control group 1: The diagnosis was consistent with the diagnostic criteria of Bohan and Perter classification system, and it was confirmed that dermatomyositis was combined with pulmonary interstitial disease;
3. Control group 2: The diagnosis meets the classification criteria of systemic lupus erythematosus revised by the American College of Rheumatology (ACR) in 1997 and is confirmed as systemic lupus erythematosus combined with pulmonary interstitial disease, or the diagnosis meets the diagnostic criteria of rheumatoid arthritis introduced by ACR in 1987 or ACR in 2010 and is confirmed as rheumatoid arthritis combined with pulmonary interstitial disease.
4. Age 18-70 years old;
5. Have a good understanding of their own illness and physical condition, have self-knowledge, can communicate well with others;
6. Voluntarily join the study, understand the significance of the experiment and the indicators to be measured, and sign the informed consent.

Exclusion Criteria:

1. Severe infection: fever, cough, phlegm, sore throat, abdominal pain, diarrhea, carbuncle and other skin and soft tissue infection and other clinical manifestations, blood routine white blood cell count beyond the normal range (10×109/L);
2. Severe cardiovascular disease: including chronic heart dysfunction grade 3 or above and various arrhythmias;
3. Infectious diseases: hepatitis active stage, AIDS, syphilis, etc.
4. Tumor markers of patients suggest the possibility of tumor.
5. Patients with neuromuscular disease, inflammatory bowel disease, functional gastrointestinal disease;
6. The patient has other connective tissue diseases or disorders.
Low Dose Spinal Bupivacaine for Total Knee Replacement and Recovery Room Wait Time

This study plans to investigate whether a reduced dose of bupivacaine (a local anesthetic numbing drug) injected into the spinal space for a total knee replacement will result in a shorter time to discharge from the recovery room while maintaining adequate surgical anesthesia.

With the doses of bupivacaine currently being used in spinal anesthetics at our institution, patients' sensory blocks are often much higher than needed to achieve adequate surgical anesthesia. This translates into a prolonged waiting period in the recovery room before the level regresses down to the pre-existing standard for discharge to the ward, as well as the pre-existing level before a post-operative nerve block for extended pain relief can be performed. This prolonged period in the recovery room leads to general delays in operating room usage and thus surgical cancellations. The excessive drug doses currently used also put patients at risk for increasing side effects including low blood pressure, slow heart rates, and nausea and vomiting.

By using a reduced dose of bupivacaine in a spinal anesthetic for a one sided knee replacement, we hope to significantly reduce the recovery room waiting times until the criteria for recovery room discharge or completion of a post-operative nerve block are met, while still providing adequate surgical anesthesia.

Patients will receive either 9 mg (intervention dose) or 13 mg (control dose) of bupivacaine through a spinal injection. Once the patients enter the recovery room after surgery the level of their sensory block will be tested as per usual protocol by the recovery room nurses every 15 minutes until a predefined level has been reached, and the two groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective one-sided total knee replacement for osteoarthritis at our institution where spinal anesthesia has been chosen by the patient and the anesthetist

Exclusion Criteria:

* Contraindications to spinal anesthesia (such as increase pressure in brain, bleeding disorder, serious valvular heart disease, serious infection in the blood or on your lower back, certain neurological disorders such as multiple sclerosis, desire for a general anesthetic)
* Allergies to local anesthetics, morphine or fentanyl
* Both knees being done at same surgery
* Revision of a previous knee replacement
* Knee replacement for reasons other than osteoarthritis (such as rheumatoid arthritis)
* Potential for difficult intubation in case of need for general anesthetic
* Patients under 150 cm or over 200 cm
* BMI greater than 40
* Lack of patient consent or patient refusal
IGNITE Firefighters' Health

Investigators hope to learn about potential dietary intervention strategies (specifically a whole-food, plant-based diet) that may help lower cancer markers in firefighters.

The purpose of the San Francisco (SF) Firefighter's Diet Study is to determine if a diet low in processed foods, mostly plant-based, with added fermented foods, can lower the risk of cancer in firefighters. We will assess this by randomly assigning SF firefighters to either a whole-food, plant-based diet or their usual firehouse meals. Participants will be followed for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+
* Active SF firefighter
* Willing to consume a plant-based diet (vegetables, fruit, whole grains, legumes, etc.)
* Willing to complete 4 clinic visits

Exclusion Criteria:

* Weight \< 110 lb
* BMI \>= 40
* Self-reported uncontrolled hypercholesterolemia, hypertension or diabetes
* Pregnant, lactating, or planning to become pregnant during the course of the study.
* Use of any of the following drugs/supplements within the last 2 months:

  * systemic antibiotics, antifungals, antivirals, or antiparasitics (intravenous, intramuscular, or oral);
  * corticosteroids (intravenous, intramuscular, oral, nasal or inhaled);
  * cytokines;
  * methotrexate or immunosuppressive cytotoxic agents.
* Chronic, clinically significant, or unstable (unresolved, requiring ongoing changes to medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional abnormality, as determined by medical history, Type 1 diabetes, dialysis
* History of active cancer in the past 3 years except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision
* Unstable dietary history as defined by major changes in diet during the previous month, where the subject has eliminated or significantly increased a major food group in the diet.
* Recent history of chronic excessive alcohol consumption defined as more than five 1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer or five 5-ounce servings of wine per day; or \> 14 drinks/week.
* Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (primary or acquired) including HIV infection, multiple sclerosis, and Graves' disease.
* Surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time.
* Regular/frequent use of smoking or chewing tobacco, e-cigarettes, cigars or other nicotine-containing products
* Regular use of prescription opiate pain medication
Behavioral Interventions for Improvement of Adherence at Exercise-based Cardiac Rehabilitation (ECRA)

The purpose of this study is to investigate the effects of an extended behavioral intervention in exercise-based CR for improvement of physical capacity, adherence, psychological and physiological parameters, compared with usual care.

Consecutive patients will be included at the coronary care unit (CCU), Linköping University Hospital, Sweden. Physiotherapists ask patients for informed consent at the CCU and book an appointment at the exercise-based CR 2-3 weeks after discharge for baseline tests. After baseline testing patients will be randomized to either extended intervention or routine care. Randomization will be stratified by submaximal exercise capacity. Patients randomized to the extended intervention group receive an additional appointment to a physiotherapist within a week. Thereafter patients in both groups start the exercise-based CR program, including aerobic exercise and resistance exercise, 3 times/week for 16 weeks, according to international guidelines for exercise-based CR.

The extended intervention is based on components from behavioral medicine including: specific goal-setting, self-monitoring and feed-back.

Changes in the endpoint variables will be measured from baseline to first (16 weeks at end of intervention) and second (12 months after index event) follow-up visits.

Sample size calculations are based on previous clinical data from a similar exercise-based CR setting (n=50) on differences in aerobic exercise capacity measured by submaximal exercise test (watts) before vs after finished exercise-based CR. With a power of 80% and a two-sided significance level of p\<0.05 and least mean difference at 10 watts (SD 20 watts) and a calculated loss of follow-up of 20%, the estimated sample size is 160 patients.

Eligibility Criteria:
Inclusion Criteria:

* Primary care event due to coronary artery disease and/or percutaneous coronary intervention (PCI) at the coronary care unit, Linköping University hospital
* Age \<75 years

Exclusion Criteria:

* Serious physical or psychological disease interfering with participation in exercise-based CR
* Inability to understand the Swedish language