cyrilzakka/clinical-trials huggingface dataset:
The Effects of JNJ-42165279 on the Neural Basis of Anxiety Disorders in Healthy Male Volunteers

The purpose of this study is to evaluate the potential efficacy of JNJ-42165279 in treating anxiety disorders through evaluation of brain activation patterns using imaging technology in healthy volunteers.

This is a single site, double-blind (neither investigator nor the participant knows the treatment that the participant receives) study. The study will consist of a screening phase (1-2 visits), a treatment phase (4 visits), and a post treatment phase (follow-up safety visit, 7 to 14 days after the last dose of the study drug). During the screening phase, participants will be evaluated to determine if they meet the study eligibility criteria, which will include collection of blood and urine samples. During the treatment phase, eligible participants will be assigned by chance (like a toss of a coin) to receive either JNJ-42165279 100 mg or placebo once daily during 4 consecutive visits to the clinic. Placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect. The potential of the drug to treat anxiety will be assessed on Day 4 of the treatment phase. The primary assessment, Blood Oxygen Level Dependent Functional Magnetic Resonance Imaging (BOLD-fMRI), will measure brain activity patterns while participants complete 3 emotionally-provoking tasks. Additionally, participants' startle responses (eye blinks) will be evaluated in two emotionally-provoking behavioral tasks outside of the scanner. Questionnaires will be completed to evaluate participants' mood, and blood samples will be collected to measure concentrations of JNJ-42165279 and biomarkers of drug activity.

Safety will be monitored throughout the study, including adverse events, vital signs (blood pressure and heart rate), 12-lead ECGs, physical examinations, clinical safety laboratories, evaluation of suicidal risk, and a Walk and Turn test. The total study duration will be approximately 46 days.

Eligibility Criteria:
Inclusion criteria

* Good general health
* Body mass index between 18 and 30 kg/m2 and body weight not less than 50 kg
* Must adhere to required contraception during and for 3 months after study
* Must agree to not donate sperm during and for 3 months after study
* Must agree to not donate blood during and for 1 month after study
* Able to speak and understand English fluently

Exclusion criteria:

* Clinically significant medical or psychiatric illness
* Any contraindication to magnetic resonance imaging
* Unable to pass hearing test
* Alcohol or substance abuse; excessive nicotine or caffeine use
* Recently received an investigational drug, vaccine, or invasive medical device
* Unable to abide by protocol restrictions on use of other medications
Effects of EMS Training on Muscle Strength

The goal of this study is to determine the effects of EMS induced muscle strengthening on muscle strength and muscle bulk in young healthy adults. The main question it aims to answer is:

Will Electrical muscle stimulation significantly improve muscle strength in young adults.

The participants falling in our inclusion criteria will be given a brief description about the exercise protocol. After informed consent, the participants will be randomized into two groups: Group A (Experimental group) and group B (Control group). Both groups will perform 10 minutes of same warm up exercises (Arm swings, jogging on the spot, Walks on treadmill). After warm up exercises, the participants in Group A (Experimental group) will perform resistance exercises with induced EMS while Group B (Control group) will perform same resistance exercises without EMS.

The Electrical muscle stimulation (EMS) is a popular technique in the fields of physical therapy, rehabilitation, and sports training for decades. EMS involves the use of electrical impulses to stimulate muscle contractions, which can help prevent muscle atrophy, improve blood flow to the area, and promote healing. It has also been used to increase muscle strength and endurance, making it an effective tool for rehabilitation and sports training.

Some research has suggested that EMS may improve muscle mass, but this is likely to be a result of increased muscle activation and recruitment, rather than actual muscle hypertrophy (i.e., an increase in the size of individual muscle fibers). In other words, EMS may help to strengthen existing muscle fibers and improve muscle tone, but it is unlikely to result in significant increases in muscle size

The aim of this study is to investigate the potential effects of electrical muscle stimulation (EMS) training on muscle strength in young and healthy adults. EMS involves the use of electrical impulses to stimulate muscle contractions, and it has been suggested as a time-efficient and effective method for increasing muscle strength and overall fitness. However, there is limited scientific evidence on the effectiveness of EMS training on muscle strength in young and healthy adults. Therefore, this study aims to address this gap in the literature by examining the effects of EMS training on muscle strength in this population.

Eligibility Criteria:
Inclusion Criteria:

* Male.
* 18-35 years.
* Training for more than 6 months

Exclusion Criteria:

* Any systemic disease.
* Any musculoskeletal disorder.
* Any structural deformity.
* Recent injury or trauma.
* Individuals with implanted medical devices.
Adductor Canal Block Versus Patient Controlled Analgesia, in the Surgical Stress Response for Anterior Cruciate Ligament Repair

To evaluate the surgical stress response in anterior cruciate ligament repair with an adductor canal block versus patient controlled endovenous analgesia.

Preoperative, 2 hours and 24 hours stress biomarkers will be evaluated in two groups of patients, continous adductor canal block and morphine patient controlled endovenous analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Male,
* 18-65 years,
* traumatic Anterior Cruciate Ligament tear, scheduled for elective arthroscopic repair with Semitendinous-Gracillis technique at first time in the morning, with full articular range,
* no other traumatologic lesions.

Exclusion Criteria:

* denied consent to participate,
* chronic steroids user,
* diabetes type 1 or 2,
* insulin resistance,
* concurrent infectious disease,
* cognitive failure, coagulopathy,
* allergy to study drugs,
* surgery scheduled in the afternoon
Acute Food INtake Effect of Hemp Protein (A FINEH Protein) Trial - Part 2

The objectives of this trial are to investigate whether the effects of hemp protein on glycemic and appetite control are insulin-dependent by measuring 1) blood glucose, insulin and appetite for one hour following consumption, 2) blood glucose, insulin and appetite following a fixed energy meal to determine the "second meal effect" of hemp protein versus soybean protein and a non-protein control.

The objectives of this trial are to investigate whether the effects of hemp protein on glycemic and appetite control are insulin-dependent by measuring 1) blood glucose, insulin and appetite for one hour following consumption, 2) blood glucose, insulin and appetite following a fixed energy meal to determine the "second meal effect" of hemp protein versus soybean protein and a non-protein control. The objectives of this trial are to investigate whether the effects of hemp protein on glycemic and appetite control are insulin-dependent by measuring 1) blood glucose, insulin and appetite for one hour following consumption, 2) blood glucose, insulin and appetite following a fixed energy meal to determine the "second meal effect" of hemp protein versus soybean protein and a non-protein control.

Eligibility Criteria:
Inclusion Criteria:

* Normoglycemic (\<5.6 mmol/L)
* Body mass index (BMI) of 18.5-29.9 kg/m2.

Exclusion Criteria:

* Restrained eaters
* Regularly skip breakfast
* Smokers
* Those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year.
To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Children Aged From 24mons-15yrs

The purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis A vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2 doses administered with 6 months interval).

The purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis A vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2 doses administered with 6 months interval).

This study is a two-group comparative study using a marketed inactivated hepatitis A vaccine (HAVRIX®, manufactured by GSK) as a control. The study will demonstrate non-inferiority of the test vaccine compared to the control vaccine.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female children ≥ 24 months and ≤ 15 years old on the day of first vaccination
2. Subjects with no history of hepatitis A and no previous vaccination against hepatitis A
3. Written informed consent obtained from the subject's legal representative (parents or representative)
4. Children who no health issues based on medical history and physical examination as judged by the investigator

Exclusion Criteria

1. Tympanic temperature of 38.0℃ or above within 48 hours prior to vaccination or on the day of vaccination
2. Uncontrolled epilepsy or neurological disorder
3. History of thrombocytopenia or has a risk of bleeding
4. History of hypersensitivity to the following: neomycin, formaldehyde, gentamicin sulfate, any vaccine
5. Severe acute or chronic infectious disease on the day of vaccination
6. Congenital / acquired immunodeficiency or receiving immunosuppressive therapy
7. Received immunosuppressive dose of systemic corticosteroids within 12 weeks prior to the first vaccination with the IP (Investigational Product) (equivalent potency of ≥ prednisolone 20 mg/day or equivalent potency of ≥ prednisolone 2.0 mg/kg/day in \< 10kg of body weight for ≥ 14 consecutive days)
8. Administration of any other vaccine within 4 weeks prior to Screening
9. Planned administration of any other vaccine within 4 weeks after the last vaccination of the investigational product
10. Administration of immunoglobulins or blood products or received blood transfusion within 12 weeks prior to Screening
11. Currently participating in another clinical trial or administered / applied other investigational product / medical device within 6 months prior to Screening
12. Ineligibility for participate in the study for other reasons as determined by the investigator
Ambulatory Measurements of Physiological Parameters

Ambulatory monitoring of physiological variables is important in following the health status of individuals in non-hospital controlled situations. The investigators are developing a non-invasive sensor based on dynamic light scattering that is able to measure pulse, blood flow and coagulability. Oxygen saturation can also be detected with minor modification of the apparatus. The investigators plan to validate the investigators sensor by applying it to patients in the intensive care unit, or to patients undergoing cardiac stress tests. The results of the investigators sensor will not be utilized for any therapeutic decisions, but will be collected for later comparison with conventional monitoring of pulse and oxygenation with standard monitors. The monitor is worn like a wrist watch, and will collect data into a small data storage disc for later analysis.

Subjects to be studied will be either individuals undergoing routine cardiac stress tests, or patients admitted to the pulmonary ward of Meir Hospital who are being monitored in conventional manner. Normal volunteers will also be tested, under the following conditions: at rest, while running, while performing calisthenics, and while crawling on the ground. If non-inferiority of the new sensor is established compared to the standard clinically used sensors, then additional studies will be performed on acutely ill patients, such as patients admitted with multi-trauma.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are able to sign informed consent.
* Patients undergoing standard cardiac stress tests who are able to sign informed consent.
* Patients with pulmonary disease who are being monitored in a routine manner who are will ing to sign informed consent.

Exclusion Criteria:

* Children
* Patients unable or unwilling to give consent
Different Injection Site Maps & Intravesical Botulinum Toxin

Botulinum toxin injection into the bladder is used in current practice in urological diseases such as overactive bladder or interstitial cystitis. As far as is known, botulinum toxin injection sites have not been clearly defined. In this study, investigators are planning to compare botulinum toxin effectiveness with different injection site maps.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Interstitial cystitis patients
* Overactive bladder

Exclusion Criteria:

* younger than 18 years
Immunogenicity, Safety and Optimal Dose Finding Study of Recombinant Influenza H5N1 Vaccine in Healthy Young Adults

UMN-0501 is a purified recombinant influenza HA vaccine (A H5N1/Vietnam/1203/2004).

The purpose of the present study is to evaluate immunogenicity, safety and optimal dose among three different doses of UMN-0501 following two same-dose vaccinations of UMN-0501 per patient with a 3 week interval between vaccination in healthy young adults.

Immunogenicity will be confirmed by both microneutralization (MN) antibody and hemagglutination inhibition (HAI) titer levels in the serums of subjects after receiving different doses of UMN-0501. There will be three dose groups with 30 subjects per group for a total of 90 healthy young adults aged 20-40 years enrolled in this study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult as determined by medical history, physical examination, laboratory test, and clinical judgment of the investigator.
* Males and females aged 20-40 years.
* Provides signed informed consent form after received a detailed explanation of the study protocol prior to any study procedures.

Exclusion Criteria:

* Body Mass Index (BMI) 30 kg/m2 and above.
* Has a history of a A/H5N1 influenza virus infection and subjects had received other A/H5N1 influenza vaccine.
* Has a history of allergic reaction by food and medicine including vaccine, and acute fever illness (greater than 39.0C) within 2 days of vaccination.
* Has a history of Guillain-Barre syndrome or acute disseminated encephalomyelitis (ADEM).
* Has severe allergic diseases.
* Has asthma.
* Has a history of convulsions.
* Has a history of any serious disease.
* Known impairment of imune function.
* Known rheumatism and autoimmune disease.
* Receipt of medicines that would affect evaluation of immunogenicity.
* Receipt of any live virus vaccination or receipt of any inactivated vaccine/toxoid prior to enrollment.
* Blood donation prior to enrollment.
* Receipt of another investigation agent prior to enrollment.
* History of alcohol or drug abuse.
* Females who are pregnant or potentially childbearing or are breastfeeding.
* Ineligible subject based on the judgement of the investigator.
A Maintenance Program for the Be Fit Employee Wellness Program

This research study is being done: 1) to determine if the MGH Be Fit program helps employees to change their nutrition and exercise habits and lower their risk for chronic diseases, such as heart disease and diabetes and 2) to determine if a maintenance program following the Be Fit 12 week program will help employees to keep the positive health changes.

The main objectives of this trial are to determine if employees who participate in the Be Fit 12 week program and are randomized to a 9 month maintenance program are more likely to maintain weight loss, physical activity level, and reduction of other clinical risk factors for disease compared to the control group. Secondary objectives are to determine if employees who participate in the maintenance intervention have fewer chronic diseases related to lifestyle factors and lower health care costs at 3 years.

Eligibility Criteria:
Inclusion Criteria:

* MGH (benefited) employees who enroll in the Be Fit program
* Able to commit to 1 year of active research participation

Exclusion Criteria:

* Not enrolled in the Be Fit program
* Decline participation in the research study
* Withdrawal from the Be Fit 12 week program prior to completion
* Women who are currently pregnant or suspect they may be pregnant
* Plans to leave MGH within 3 months from enrolling in Be Fit
Testing a Self-affirmation Intervention for Use in a Mobile Application

The aim of these studies is to adapt the self-affirmation kindness questionnaire for use in a mobile application. Two studies will be conducted to test hypotheses that simplifying and shortening the original questionnaire in systematic ways will result in comparable effectiveness (compared to the original version) in promoting reduced defensive avoidance, less reactance, greater yielding, and higher intentions to quit smoking among a sample of smokers.

Research has shown that self-affirmation interventions, in which people are instructed to focus on their strengths and values, can offset self-threats and promote healthier behaviors, such as smoking cessation. A commonly used self-affirmation intervention is known as the "kindness quiz." The original kindness questionnaire (Reed \& Aspinwall, 1998) consists of 10 yes/no questions, and participants are asked to think about and write down an example of each. For example, one item is "Have you ever been considerate of another person's feelings? ____ YES ____NO; IF YES, WRITE ABOUT A SPECIFIC EXAMPLE." The items were written so that all participants should be able to say "yes" in response to each question, which will affirm a positive view of themselves.

The purpose of these studies are to test shorter and simpler versions of this kindness questionnaire so that it can be implemented on mobile phones. In Study 1, we will test whether written examples are necessary for the effectiveness of the self-affirmation intervention (compared to no examples or imagined examples) compared to a control. In Study 2, we will again test whether written examples are necessary, as well as whether shorter questionnaires (i.e., 5 items or 3 items) are as effective as the original 10 item questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Currently live in the US
* 21-65 years (several states have 21 as minimum legal age to smoke)
* self-identified every day or some day smoker
* no prior diagnosis of lung cancer, chronic obstructive pulmonary disease, or emphysema (the most common and well-known smoking-related diseases

Exclusion Criteria:

* Not currently living in the US
* Less than 21 years of age or older than 65
* Nonsmoker
* Prior diagnosis of lung cancer, chronic obstructive pulmonary disease, or emphysema (the most common and well-known smoking-related diseases
Efficacy of Retinal Nerve Fiber Layer (RNFL) / Retinal Thickness Ratio by Cirrus OCT Utilizing Spectral -Domain Technology as a Diagnostic Predictor of Glaucoma

Glaucoma is presumed to be an axonal disease which starts at the lamina cribrosa. This assumption has led to the monitoring of the retinal nerve fiber layer thickness for the diagnosis and monitoring of progression of glaucoma. However, varying disc size, myopia and tilted discs affect the thickness of the retinal nerve fiber layer. This study aims to ascertain the ration of the retinal nerve fiber layer against full retina as a predictor of glaucoma diagnosis and progression.


Eligibility Criteria:
Inclusion Criteria:

* Primary open angle glaucoma
* Myopia
* Myopia with evidence of glaucoma
* Normal controls

Exclusion Criteria:

* Evidence of retinal disease
* BCVA \< 0.4
* Secondary glaucoma due to intraocular inflammation
* Lens induced glaucoma
* Tumor induced glaucoma
* Neovascular glaucoma
Comparison of Tacrolimus 0.1% and Clobetasol 0.05% in the Management of Symptomatic Oral Lichen Planus

This clinical study is carried out to assess the efficacy of Tacrolimus and Clobetasol in symptomatic Oral Lichen Planus.


Eligibility Criteria:
Inclusion Criteria:

* Clinically and Histologically proven Oral Lichen Planus
* Symptomatic

Exclusion Criteria:

* topical/ systemic medication for OLP in the previous three months
* contraindication for medications use such as a history of allergy to either corticosteroids/ tacrolimus
* immunosuppression, or pregnant / lactating females
* lichenoid reactions either drug induced or due to dental amalgam
* diabetes mellitus and on oral hypoglycemic drugs
* systemic involvement such as concurrent skin/genital lesions
Compliance With American Diabetes Association Treatment Guidelines for Adult Ketoacidosis

At this time, Saint Mary's Medical Center is currently in the process of implementing a standardized diabetic ketoacidosis (DKA) protocol. The first main goal of this project will be to evaluate patient outcomes to determine the effects of treating patients without a standardized protocol and to establish a baseline on how patients are being treating with DKA. The final goal of the project will be to compare outcomes of those patients not placed on the protocol to those that were treated using SMMC newly implemented DKA protocol. The overall goal of this project is to determine the benefit of an institutional DKA protocol.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to St. Mary's Medical Center with DKA
* \>/= 18 years of age

Exclusion Criteria:

* \< 18 years of age