cyrilzakka/clinical-trials huggingface dataset:
Piloting Text Messages to Promote Positive Affect and Physical Activity

The focus of the study is to assess the feasibility and acceptability of a pilot one-arm project delivering text messages related to positive psychology (PP) activities (e.g., recalling positive events) and health behavior text messages (e.g. having a heart-healthy diet, becoming more physically active). The messages will be sent for 4 weeks among patients with a prior acute coronary syndrome (ACS).

This is a single-arm study of text messaging in post-ACS patients. The convenience sample for this pilot study will be enrolled from two sources: (a) participants prospectively enrolled from inpatient cardiac units at MGH admitted for an ACS, and (b) participants in prior post-ACS studies performed with the investigators' team.

A total of 28 intervention text messages (1/day for 4 weeks) will be sent to participants following the baseline assessment. After each message is sent, participants will receive a second text message asking them to rate the utility of the message, and this rating will be used by a machine learning algorithm to select subsequent messages. This will ensure that, over time, participants will receive messages that they are more likely to find useful.

In the first part of the study, participants will receive 28 fixed text messages that alternate between physical activity and positive psychology messages. In the second part of the study, participants will receive 14 fixed text messages that range in topics from positive psychology to physical activity, diet, and medication adherence. In the second part of the study, participants will first receive a set of 14 pre-selected daily messages that contain a broad range of attributes to allow sufficient participant feedback to clearly identify preferences. After the first 14 messages, new messages will be selected based on the prior preferences of participants.

The messages will be sent using the Twilio texting program used by REDCap, which also uses Amazon Web Services. Twilio allows software developers to programmatically make and receive phone calls and send and receive text messages using its web service. The investigators have purchased a Twilio account to allow messages to come from an anonymous phone number rather than the phone of a study staff member.

Eligibility Criteria:
Inclusion Criteria:

1. Prior acute coronary syndrome.

   Acute myocardial infarction (MI):
   * Elevation of cardiac biomarkers (cardiac troponin T) in addition to one or more of the following:
   * symptoms of ischemia (e.g., acute chest pain)
   * ischemic changes on electrocardiogram
   * imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.

   Unstable angina (UA):
   * crescendo angina
   * new onset (within 1 month) angina with minimal exertion
   * angina with minimal exertion or at rest.
2. Ability to receive text messages via cellular phone.

Exclusion Criteria:

* A periprocedural ACS
* Terminal illness
* An unrelated condition limiting physical activity
* An inability to communicate in English, or
* cognitive disorder assessed by 6-item cognitive screen
Post Marketing Surveillance of Safety and Efficacy for Cholib in Korean Patients Under the "New Drug Re-examination".

Post marketing surveillance of safety and efficacy for Cholib in Korean patients under the "New Drug Re-examination"

The objective of this surveillance is to identify problems and questions on Cholib® and on the following matters under the condition that the investigational product is in use.

1. Serious adverse event and adverse drug reaction profile

   * Death or a life-threatening condition
   * Hospitalization or prolonged hospitalization
   * Persistent or significant disability/incapacity
   * Congenital anomaly/birth defect
   * Other medically significant events
2. Unexpected adverse event/adverse drug reaction profile
3. Known adverse drug reaction profile
4. Non-serious adverse drug reaction profile
5. Other information related to the product safety
6. Efficacy evaluation
7. Study of extended follow-up Surveillance of the safety and efficacy of the subjects who received Cholib® for long-term use at least 24 weeks.
8. Study of special patient Analysis of specific patients such as elderly patients (65 years and above), patients with renal/hepatic disease

Eligibility Criteria:
Inclusion Criteria:

- Clinical diagnosis of mixed dyslipidaemia who has high triglycerides and low HDL cholesterol level while LDL cholesterol levels are adequately controlled with the corresponding dose of simvastatin monotherapy

Exclusion Criteria:

* Patients who are hypersensitive (allergic) to peanuts, soybean or any of the ingredients of the medicine
* Patients who experienced photoallergy or phototoxic reactions during treatment with fibrates or ketoprofen
* Patients who have active hepatic disorder or have serum transaminase increased continuously without identified reason
* Patients who have gallbladder disease
* Patients who have chronic or acute pancreatitis except acute pancreatitis due to severe hypertriglyceridemia
* Patients who have moderately or severely reduced kidney function(estimated glomerular filtration rate \< 60mL/min/1.73m2)
* Cholib® administration combined administration with fibrates, statins, danazol, cyclosporine or strong cytochrome P450(CYP)3A4 inhibitor
* 145/40mg Cholib® Combined administration with amiodarone, verapamil, amlodipine or diltiazem
* Children \<19 years
* Pregnant or breast-feeding women
* Patients with biliary cirrhosis
* Patients who have myopathy and/or previously had rhabdomyolysis or myopathy while taking statins and/or fibrates or had 5 times more creatine phosphokinase than Upper limit of Normal (ULN) while taking statins previously
* Patients who have rare hereditary problems with lactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption since this drug contains lactose
* Patients who have rare hereditary problems with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency since this drug contains sucrose
* Patients who have LDL Cholesterol ≥130 mg/dL and triglyceride \< 150mg/dL and HDL cholesterol ≥60mg/dL Investigators will refer to the product market authorization (label) for inclusion/exclusion criteria
Clofazamine for the Treatment of Mycobacterium Avium Intracellulare(MAI)

This protocol is an single patient IND to provide clofazamine to treat one patient who has MAI and is resistant to or can not tolerate standard of care. The drug is not otherwise available.


Eligibility Criteria:
Inclusion Criteria:

* Treatment of one patient with MAI

Exclusion Criteria:

* No other patients will be treated
Blood Flow and Bone Density in Healthy Adult Women

This project will test the efficacy of using a non-invasive neuromuscular stimulation on the plantar surface of the feet to prevent and/ or reverse bone loss in a sample of healthy adult women.

Women between the ages of 30 and 60 years of age who work in positions that require them to be seated at desks for a large portion of each day, are capable of following the protocol for one year, have a t-score \>- 2.5 (do not have osteoporosis), and respond to plantar stimulation will be asked to participate. Women will be excluded who are receiving medications for osteoporosis, taking hormone replacement therapy, taking steroids (either oral or inhaled), have metal implants in the tibia, hip and spine that interfere with DEXA (bone density) scanning, are professional or semi-professional athletes, have hyperparathyroidism, have a history of pulmonary embolism, deep vein thrombosis, peripheral vascular disease or varicose veins, have a Body Mass Index greater than 40 Kg/m2, have any type of neuromuscular disease, or are pregnant . Once the inclusion and exclusion criteria are met, 45 subjects will be randomized into 3 groups including 1) a group of 15 subjects who will use the device (stimulation) for up to 4 hours a day, 2) a group of 15 subjects that will use the device for up to 8 hours a day, and 3) a control group who will not use the device. Subjects in the two treatment groups will be asked to place their feet on a mechanical device that will deliver a slight vibration while they are seated at work. Vibrations between 30-60 Hz has been shown to stimulate the Meissner's corpuscles which in turn stimulate contraction of the deep muscles of the calves. This contraction has been shown to increase venous and lymphatic return from the lower extremities thus improve bone metabolism. Bone density readings and venous circulation will be measured at the onset of this research and will be repeated after 12 months of using the device.

Eligibility Criteria:
Inclusion Criteria:

* healthy women 30 - 60 years old
* work in seated positions

Exclusion Criteria:

* weigh more than 350 pounds
* pregnant or plan to become pregnant
* professional athlete
* currently on Hormone Replacement Therapy
* currently taking medication for osteoporosis
* currently on corticosteroids
* metal implants in tibia hip spine forearm
* diagnosed with hyperparathyroidism
* diagnosed with neuromuscular disease
* pulmonary embolism
* deep vein thrombosis
* peripheral vascular disease
* medications for hypertension
Dose Response Study of Patients With Erythematous Rosacea

The purpose of this study is to evaluate the dose-response relationship (effect) of four concentrations of V-101 Cream in patients with erythematous(redness) rosacea.

Patients must have moderate to severe erythematous (facial redness) rosacea

* Male and female patients must be at least 18 years old and in good general health
* Female patients must not be pregnant or nursing

Eligibility Criteria:
Inclusion Criteria:

* male or females at least 18 years of age
* diagnosis of stable erythematous rosacea
* \< 3 inflammatory lesions
* in good general health
* females must be non-pregnant and non-lactating
* must be willing to sign a consent form

Exclusion Criteria:

* have ocular, phymatous or other types of rosacea
* allergy to any ingredient in study drug
* participation in other investigational studies within 30 days of enrollment
* use of systemic steroids within 28 days of Baseline
* use of tetracycline antibiotics within 28 days of baseline
* use of products containing oxymetazoline within 14 days of baseline
* use of topical steroids witin treatment area 14 days prior to baseline
* use of Rx or OTC products for treatment of acne or rosacea within 14 days of baseline
* use of any product for reducing redness within the treatment area witin 14 days prior to baseline
* use of monoamine oxidase (MAO) inhibitors
* use of niacin \>/= 500mg/day
Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation

Post-market, on-label, double-blind, randomized, prospective, interventional, tolerability and clinical outcomes study to determine the number of patients achieving their final assigned VNS Therapy dose settings in patients with drug-resistant epilepsy who are being treated with adjunctive VNS Therapy using new titration protocols.

Post-market, on-label, double-blind, randomized, prospective, interventional, tolerability and clinical outcomes study is designed to determine which VNS Therapy titration paradigm allows more patients to achieve a therapeutic dose within a specified time frame. Additionally, the study will collect data on the acute tolerability and clinical outcomes for patients with drug-resistant epilepsy treated with adjunctive VNS Therapy employing three different titration paradigms.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must agree to be treated with VNS Therapy. The decision to treat with VNS Therapy must have been made independent of and prior to participation in the study.
2. Patients must be 12 years or older and have partial onset seizures or must follow the indication for use statement for VNS Therapy.
3. Patient and/or caregiver must be able and willing to give accurate side effect reports, global impressions data and complete study instruments with minimal assistance throughout the study.
4. Patient or legal guardian understands study procedures and voluntarily signs an informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional policies. In the event the patient is under the age of 18, the patient will also be required to sign an assent affirming agreement to participate in research according to local IRB requirements.
5. Patient must be taking at least 1 anti-epileptic drug treatment

Exclusion Criteria:

1. Patient currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
2. Patient is expected to require MRI using a body coil for transmission of RF during the clinical study.
3. Patient has a progressive neurological condition (e.g. brain tumor etc.).
4. In the investigator's opinion, the patient or legal guardian is unable to comply with the frequency of clinic visits during the study.
5. Patient is currently using an investigational device or pharmacologic medication not approved by the FDA.
6. Patient was previously implanted with VNS Therapy.
7. In the investigator's opinion, the patient is considered a suicide risk or is otherwise not a good candidate for this study.
8. Patient/Caregiver is unable to complete the required study follow-up visits and assessments.
Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor

To investigate safety and efficacy of single agent sunitinib malate in Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor.


Eligibility Criteria:
Inclusion Criteria:

* Histologically-proven diagnosis of malignant GIST (Gastrointestinal Stromal Tumors).
* Evidence of unidimensionally measurable disease
* Failure of prior treatment with imatinib or intolerant to imatinib
* Male or female, 18 years of age or older.
* ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.
* Resolution of all acute toxic effects
* Adequate organ function.

Exclusion Criteria:

* Anticancer treatment after last dose of imatinib
* Major surgery within 4 weeks or radiation therapy within 2 weeks.
* Grade 3 hemorrhage within 4 weeks prior to starting the study treatment.
* Diagnosis of second malignancy within the last 5 years.
* History of brain disease.
* Cardiac disease within 12 months.
* Thyroid function abnormality.
* Ongoing cardiac dysrhythmias.
* Uncontrolled hypertension.
* Ongoing treatment with anticoagulant and CYP3A4 inhibitors and inducers.
* HIV or AIDS related illness.
* Pregnancy or breastfeeding.
Registry Study of T Cell Depleted Allo Non-Myeloablative Stem Cell Transplant

Allogeneic transplantation is used to treat many malignant and non-malignant diseases. The investigators and others have shown that less toxic preparative regimens (reduced intensity or 'mini' transplants) allow reliable allogeneic engraftment and durable remissions, significantly broadening the population of patients who may be offered this therapy to those who are older and more infirmed. The field is now focusing on the period post transplant for approaches to immune recovery leading to improved outcomes.

The primary objective of this registry is to catalogue data from patients who undergo standard of care reduced intensity allogeneic transplantation.

Subjects will have toxicity monitored and reported per the Center for International Blood and Marrow Transplant Research (CIBMTR) program standard and as required by law for bone marrow transplant (BMT) reporting in the USA. Data will be collected from physical exam, laboratory studies, radiographs that are performed for clinical purposes. The tests and procedures are not in addition or in excess of our standards for allogeneic transplant outside of this registry. Data about donors will also be collected.

Eligibility Criteria:
Recipient Inclusion Criteria:

* Subjects ≥ 18 years of age undergoing a reduced intensity allogeneic transplant

Exclusion Criteria:

* Subjects \< 18 years of age
* Subjects not undergoing nonmyeloablative or ablative allogeneic transplant
ONO-4538 Study in Patients With Advanced Non-Small Cell Lung Cancer

The objective of the study is to investigate the safety and efficacy of ONO-4538 in subjects with stage IIIB/IV or recurrent non-small cell lung cancer unsuited to radical radiotherapy and resistant to a platinum-based chemotherapeutic regimen.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 20 years of age
* Histologically or cytologically confirmed non-small cell lung cancer
* Diagnosis of NSCLC in stage IIIB/IV unsuited to radical radiotherapy according to UICC-TNM classification (7th edition) or recurrent NSCLC
* Has at least one measurable lesion, as defined by the RECIST guideline (version 1.1)

Exclusion Criteria:

* Current or prior severe hypersensitivity to another antibody product
* Multiple primary cancers
E-bibliotherapy for Informal Caregivers of People With Dementia

The objective of this study is to test the efficacy of e-bibliotherapy on improving the psychological well-being of informal caregivers of people with dementia as compared with a control group.

This project is a two-arm randomized controlled trial evaluating the effects of e-bibliotherapy on improving the psychological well-being of informal caregivers of people with dementia. One hundred and ninety-two informal caregivers of people with dementia will be recruited. Participants in the intervention group will receive eight weekly e-bibliotherapy sessions. The control group will get access to the same e-bibliotherapy app but accept only general daily living knowledge. Psychological well-being, caregiving appraisal, mental health, biomarker of stress, and health-related quality of life will be measured to test the effects of e-bibliotherapy immediately post-intervention, three months post-intervention, and six months post-intervention. Focus group interviews will be conducted immediately post-intervention to explore caregivers' experiences participating in this study.

Eligibility Criteria:
Inclusion Criteria:

* primary caregivers aged 18 or above;
* provide unpaid regular care to a person with mild to moderately severe dementia (measured by Global Deterioration Scale, GDS=4\~6);
* have cared for the care recipient for at least six months;
* assist with at least one of the care recipient's daily activities;
* use a smartphone or tablet;
* can read Chinese.

Exclusion Criteria:

* caregivers with unstable physical or mental conditions;
* have cognitive impairment;
* are undergoing acute treatment or have not yet stabilized on their chronic medication;
* are involved in another interventional study
Integrative Therapy in Alcoholism

The main aim of this project consists in the investigation of the interaction of behavior therapy and Acamprosate in the outpatient treatment of alcoholic patients in a randomized, prospective and (regarding study medication Acamprosate vs. Placebo) double blind design. A total of 371 patients has been randomly assigned immediately after detoxification to one of three different outpatient treat-ment conditions.

The objective of this multi-center study is to optimize the long-term treatment of patients with alcohol dependence. This investigation should contribute to the issue of effective relapse prevention. Each treatment condition is lasting 6 months: a) Behavior Group Therapy + Acamprosate, b) Behavior Group Therapy + Placebo and c) support and counseling + Acamprosate. Follow-up examinations carried out 3 and 6 months after the end of treatment.

Eligibility Criteria:
Inclusion Criteria:

* DSMIV criteria of alcoholism
* Age between 25 and 60
* Informed consent

Exclusion Criteria:

* Residence outside of the catchment area
* Legal reasons
* Insufficient knowledge of the German language
* Substance abuse or addiction other than alcohol or nicotine
* Pregnancy
* Serious physical illness
* Organic brain disease
* Contraindication to Acamprosate treatment
Discriminant Ability of the Shock Index, Modified Shock Index, and Reverse Shock Index Multiplied by the Glasgow Coma Scale on Mortality in Adult Trauma Patients: A PATOS Study

We evaluated a cohort of adult trauma patients transported to emergency departments. The first vital signs were used to calculate the SI, MSI, and rSIG. The areas under the receiver operating characteristic curves (AUROCs) and test results were used to compare the discriminant performance of the indices on short-term mortality and poor functional outcome. A subgroup analysis of geriatric patients, traumatic brain injury, penetrating injury, and non-penetrating injury was performed.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years) EMS-transported from January 2016 to December 2020

Exclusion Criteria:

* Patients with missing entries of age, sex, triage, SBP, DBP, HR, or GCS were excluded.
* Entries with missing records of in-hospital mortality or 30-day mortality were excluded from the short-term mortality cohort analyses.
* Patients without a Modified Rankin Scale (MRS) record at discharge were excluded from the functional outcome cohort analyses.
Study on Lipid Profile Changes in Plasma and Intestinal Mucosa of Patients With Inflammatory Bowel Disease

This study aimed to demonstrate the characteristic lipid profile changes in patients with inflammatory bowel disease.

This study aimed to demonstrate the characteristic lipid profile changes in patients with inflammatory bowel disease.

The investigators followed up with patients with different stages of IBD and collected plasma and lesion tissues from patients and healthy volunteers for lipid metabolism-related substances to assess the changes in lipid metabolism in patients with different stages of IBD and their impact on disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients with inflammatory bowel disease; aged 18-80 years; all cases agreed to participate in the study.
* Healthy volunteers who agreed to participate in the study.

Exclusion Criteria:

* Patients with severe heart disease; patients with severe kidney disease; patients with low blood pressure; patients with severe infections such as sepsis or pneumonia; patients who have used immunosuppressants such as 6-mercaptopurine, imidazole thiopurine, and cyclosporine within a short period, and women during pregnancy; patients who are post-colon resected; patients who disagreed to participate in the study.