cyrilzakka/clinical-trials huggingface dataset:
Expressive Writing for Heart Healing

This study will determine whether the psychological and physical benefits of expressive writing extend to obese in-patients with Ischemic Heart Disease (IHD)referred to cardiac rehabilitation

Expressive writing, for as little as 3-5 sessions of 20 minutes, has been found to improve both physical and psychological health based on health outcome measures such as number of doctor's visits and hospital days, blood pressure control, lung and immune function, pain, anxiety and depression. Given its simplicity and obvious advantages in terms of cost-effectiveness, expressive writing has great potential as a therapeutic tool or as a means of self-help, either alone or as an adjunct to traditional therapies. This modality has not been studied in obese patients with Ischemic Heart Disease.

Eligibility Criteria:
Inclusion Criteria:

* obesity
* Ischemic Heart disease
* Signed informed consent

Exclusion Criteria:

* Visual or manual limitations that preclude reading and writing
* Unwilling to participate
Risk of Hypoglycemia in Type 2 Diabetes

The aim of this study is to establish the risk and frequency of non-symptomatic hypoglycemia in type 2 diabetes under previous therapy with glibenclamide. Participants will be monitored via a continuous glucose monitoring system in a standardized clinical setting during day and night time, implementing meals and exercise of moderate intensity performed in the postprandial state.

The day-to-day change of blood glucose is associated with the frequency of vascular complications and the quality of life of diabetic patients. In this study the frequency of hypoglycemic events in combination with postprandial hyperglycemia in type 2 diabetic patients on oral insulinotropic therapy will be observed. Using more sophisticated technology than before the probability of type 2 diabetic patients on glibenclamide to experience hypoglycemic episodes will be registered. Hypoglycemia is prone to cardiovascular complications in type 2 diabetic patients due to concomitant dysregulation of blood flow. With standardized test meals followed by exercise in a clinical setting hormonal counterregulation and cardiovascular parameters associated with hypoglycemia will be identified. The acute effect of different conditions of exercise and a single dose of either glibenclamide or placebo will be followed each day during the total three-day observation period. Thus we will evaluate the frequency of and the risk factors associated with hypoglycemia and meal-related hyperglycemia in type 2 diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes on glibenclamide with or without
* Glycated hemoglobin ≤ 7.5%
* Stable dosage for three weeks

Exclusion Criteria:

* HbA1c \> 7.5%
* Fasting C-peptide below normal
* Concurrent infectious disease
* Pregnancy
* Malignant disease
* Inability to give informed consent
The Impact of Clavicular Length Restoration in the Treatment of Non-unions of Clavicular Midshaft and Lateral Fractures

Evaluating the impact of plate treatment and cortical bone grafting of clavicular midshaft and lateral non- unions on restoration of clavicular length and bony healing and its association with functional outcome.


Eligibility Criteria:
Inclusion Criteria:

* clavicular midshaft and lateral non- union treated by plate and iliac crest bone grafting
* minimal follow- up of two years after surgery
* written informed consent

Exclusion Criteria:

* legal incompetence
* non- union of pathologic fractures
* current pregnancy
* German language barrier to complete questionnaires
Reconstruction of Diffusely Diseased Left Anterior Descending with Left Internal Mammary Artery On-lay Patch or Saphenous Vein Patch Without Endarterectomy by Opening the Whole Wall of the Diseased Segment(s) Has Less Risk and Fewer Complications Compared to Endarterectomy Technique

The objective of this study is to compare different surgical strategies for management of severely diseased LAD artery during CABG i.e. LIMA on-lay patch vs. saphenous vein patch and the distal in situ LIMA and saphenous vein graft (LIMA+ SVG).

Total myocardial revascularization is the primary aim of coronary artery bypass grafting (CABG) . Conventional CABG does not attain sufficient myocardial revascularization in severely diseased left anterior descending coronary artery (LAD). Coronary endarterectomy for severely atherosclerotic LAD was first introduced by Bailey and his coworkers , but it has a higher risk of morality and poor outcomes. The reconstruction of LAD with saphenous vein or left internal mammary artery (LIMA) combined with endarterectomy was described by Fundaro and others surgeons for better long-term patency of LIMA graft and to avoid the drawbacks of endarterectomy. Reconstruction of diffusely diseased LAD with LIMA on-lay patch or saphenous vein patch without endarterectomy by opening the whole wall of the diseased segment(s) has less risk and fewer complications compared to endarterectomy technique. However, the superiority of LIMA path versus saphenous vein patch is still controversial.

In addition, the LIMA patch is occasionally not available as a bypass to LAD, for example with relatively shorter LIMA due to enlarged left ventricle, difficulty in harvesting the proximal LIMA, accidental injury of the LIMA pedicle during harvesting, calcification of the middle or distal LIMA or mismatching between the LAD and distal LIMA. To overcome this, an end-to-end anastomosis with the distal in situ LIMA and saphenous vein graft (SVG) was performed to establish a composite graft to bypass the LAD.

Eligibility Criteria:
Inclusion Criteria:

* included patients with long-segment diffusely diseased LAD, with good ejection fraction and elective surgery.

Exclusion Criteria:

* Patients with associated valve surgery, left ventricular EF less than 40%, and severe comorbidities (renal or liver failure), preoperative dialysis, and hemodynamic instability, emergency operations were excluded.
Clinical Evaluation of the Efficacy of Fractional Radiofrequency for the Treatment and Reduction of Stretch Marks

This is a prospective, single centre, evaluator-blind study of the performance of fractional radiofrequency (RF) for the treatment and revision of stretch marks. The study will evaluate the progress of 15 subjects requesting treatment of stretch marks. The study will involve four treatments on both sides of the face with 4 week intervals between each treatment. Subjects will be followed at 12 and 16 weeks after their last treatment. Analysis will be performed on all subjects who receive at least one treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy, male or female subjects, 18-60 years of age who are seeking treatment for their stretch marks
2. Fitzpatrick skin type I-IV
3. Able to read, understand and voluntarily provide written Informed Consent.
4. Able and willing to comply with the treatment/follow-up schedule and requirements.

Exclusion Criteria:

1. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
2. Subjects with any implantable metal device in the treatment area
3. Permanent implant in the treated area, such as metal plates and screws (excluding dental implants), or an injected chemical substance.
4. Current or history of any kind of cancer, or dysplastic nevi in the treated area.
5. Severe concurrent conditions, such as cardiac disorders.
6. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
7. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.
8. Poorly controlled endocrine disorders, such as diabetes.
9. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
10. History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
11. History of bleeding coagulopathies, or use of anticoagulants.
12. Use of isotretinoin (Accutane®) or other systemic retinoids limited up to 10mg/day or as per investigators discretion.
13. Treating over tattoo or permanent makeup.
14. Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
A Drug-Drug Interaction Study of Ambroxol and Levodropropizine

The purpose of this study is to evaluate the drug-durg interaction between ambroxol and levodropropizine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male
* Age between 20 and 55
* Signed informed consent

Exclusion Criteria:

* Has a history of hypersensitivity to IP ingredients
* Hypotension or hypertension
* Has a history of acute infection within 14 days of screening
Study to Evaluate Safety and Efficacy of PreCrea® on Subjects With Higher Than Normal Blood Sugar Levels

The purpose of the study is to evaluate the efficacy and safety of PreCrea® on subjects with higher than normal blood sugar levels.

A Prospective, Double Blind, Placebo-Controlled, Randomized, Multicentric, study to evaluate the efficacy and safety of PreCrea®, a twice-daily dietary supplement in people with higher than normal blood sugar levels.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years to ≤ 65 years
2. Newly diagnosed Male or Female participants with higher than normal blood sugar levels (FPG \>100 mg/dL) on of Pre-Diabetes and Diabetes Mellitus during screening and not on any treatment
3. Ability to understand and willingness to sign and date a written Informed Consent Document at the screening visit before any protocol- specific procedures are performed and willing to adhere to the protocol and entire trial procedures

Exclusion Criteria:

1. Subjects with Type 1 Diabetes Mellitus
2. Participants on insulin therapy and other oral anti-diabetic agents or having uncontrolled diabetes.
3. Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months.
4. Cardiac status New York Heart Association class III-IV
5. Uncontrolled blood pressure \> 150 mmhg systolic and \> 100 mmhg diastolic
6. Impaired renal function as shown by but not limited to serum creatinine ≥ 1.5 mg/dl for males and ≥ 1.4 mg/dl for female
7. Clinically significant peripheral edema
8. Clinical evidence of active liver disease or serum alenine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5 times the upper limit of the normal range (2.5 X ULN)
9. Participants on steroid
10. Pregnancy or lactating women
11. Known hypersensitivity to any of the study drugs
12. Any malignancy within the last 5 years, with exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated carcinoma insitu.
13. Current addiction or current alcohol abuse or history of substance or alcohol abuse within the last 2 years
14. Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
15. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study. Subject unlikely to comply with protocol e.g. uncooperative attitude, inability to return for follow up visits and unlikelihood completing of the study.
16. Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study.
Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish

To assess discoloration of carious primary teeth after application of silver diamine fluoride versus sodium fluoride varnish.

The American Academy of Pediatric Dentistry's (AAPD) guidelines (2017) stated that Silver diamine fluoride (SDF) is a brush-on liquid that arrest 87.7% of dental caries lesions. The success rate is similar for restorations placed under GA. One of the most exciting aspects of SDF is the 67±4% decrease in new lesions on untreated surfaces, achieved simply by treating active lesions .This is not the same as incidence of any new lesions (elaborated above for treatment under GA), however the relation warrants further investigation.

Benefit to the patient

* No pain and infection.
* Enhance child cooperation.
* Enhance better patient compliance.
* Decrease cost of dental treatment and may eliminate the need for General Anesthesia.

Benefit to the dentist

* Develop an effective fast easy method to arrest the caries by using SDF.
* Ease of dental treatment.
* Better cooperation with the child.
* The procedure is simple.
* Inexpensive and non-invasive.
* It does not require expensive equipment or support infrastructure, such as pipe water or electricity.

Benefit to the population

* Reduce the harmful impact of oral health problems in preschool children from low income families.
* SDF can be considered a user-friendly material for use in dental clinics as well as remote areas, schools or deprived communities.

Children aged 2-5 years can benefit from the use of SDF, an easy anticaries treatment. Furthermore, children in this age group may benefit from delayed dental treatment and overall caries arrest, thus reducing potential pain and infection, expensive future emergency room visits, the need for general anesthesia or traumatic dental experiences on uncooperative children.

Eligibility Criteria:
Inclusion Criteria:

1. Children with carious primary teeth before eruption of permanent teeth
2. High caries risk patients with anterior or posterior carious lesions
3. Uncooperative children without access to or with difficulty accessing dental care.

Exclusion Criteria:

1. Children with spontaneous or elicited pain from caries
2. Tooth mobility
3. Signs of pulpal infection
4. Severe medical conditions that would not allow management in the clinic
Use of a Colorectal Cancer Screening Decision Support Tool in Primary Care

The research question we pose is, Does a colorectal cancer (CRC) screening decision support tool offered in advance of primary care visits increase CRC screening completion rates? Our work aims to answer this question by evaluating the effectiveness of an MGB decision support tool to 1) promote informed decisions about CRC screening for average risk patients ages 45-75, 2) deploy a decision support tool as part of a primary care bundle questionnaire, and 3) support patients in completing their preferred method of CRC screening.

As part of usual care, a CRC screening electronic decision support tool developed by Mass General Brigham has been integrated into Epic. This decision support tool is part of routine clinical care and is sent electronically to patients aged 45-75 who receive the Annual Visit Primary Care Screening Bundled Questionnaire in advance of their annual visit. Patients complete the tool on Patient Gateway prior to the visit or via an iPad at the visit. The decision support tool guides patients through the CRC screening options (e.g., FIT, colonoscopy, Cologuard) to help them select their preferred screening method. As part of routine care, the patient will be prompted to complete the tool as part of the bundled questionnaire, and the results will be available in the Epic encounter in the Screenings tab with the other screening bundle responses. The primary care clinician can then discuss the options and/or screening preference with the patient. Depending on what the patient and clinician decide, a CRC screening test may be ordered for the patient. As a secondary outcome, a random sample of 1000 patients will be surveyed to understand their involvement in the decision making process and 300 providers will be surveyed to understand how the decision tool impacted the conversation with the patient. The IRB to conduct surveys of patients and providers was approved by the Mass General Brigham IRB (Protocol # 2024P002568).

Eligibility Criteria:
Inclusion Criteria:

Adults aged 45-75 overdue for CRC screening at average risk of CRC have an annual visit scheduled with participating practices

Exclusion Criteria:

* high risk of CRC
A Pharmacokinetic Study on Co-administration of Tamiflu (Oseltamivir) and Rimantadine in Healthy Volunteers

This open label, randomized, three-period crossover study will evaluate the effect of co-administration of Tamiflu (oseltamivir) and rimantadine on the pharmacokinetics of Tamiflu and rimantadine. Healthy volunteers will receive multiple oral doses of Tamiflu, rimantadine or Tamiflu plus rimantadine in random order, with a minimum wash-out period of 7 days between treatments. Anticipated time on study is up to 11 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adults, aged 18 to 45 years
* Healthy as judged by general physical examination, medical history, vital signs, 12-lead ECG and laboratory tests
* Body Mass Index (BMI) 18-34 kg/m2
* Willing not to participate in any other trial including an investigational drug for 3 months following the last dose
* Male subjects must agree to use a barrier contraception during the study and for 3 months after discontinuation of treatment
* Female subjects of non-child bearing potential or under effective contraception who are either post-menopausal, surgically sterile, or who agree to use barrier contraception during the whole study in addition to an intrauterine device or hormonal contraception for at least 3 months prior to 1st dose, during the study and for 3 months after discontinuation of treatment

Exclusion Criteria:

* History of or current clinically significant disease or disorder
* Positive Hepatitis B, Hepatitis C, HIV 1 or 2 test result
* Positive pregnancy test or lactating women
* Clinically relevant history of allergy or hypersensitivity
* Clinically relevant history of abuse of alcohol or other drugs; tobacco smoking is allowed (\</= 10 cigarettes a day or equivalent of tobacco in cigars or pipe)
* Any major illness within 30 days prior to screening examination
* Administration of any medication during the 7 days prior to drug administration, except for paracetamol and aspirin (up to 48 hours before first dose) and oral contraceptives
* Participation in a clinical study with an investigational drug within 3 months prior to study day 1
* Donation or loss of more than 500 mL of blood within the 3 months prior to study day 1
A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease

The study hypothesis is to establish the safety and tolerability of long-term open-label (OL) CP-690,550 therapy in subjects with Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who complete 26-week maintenance treatment of the A3921084 study or subjects who withdraw early due to A3921084 study treatment failure (see Appendix 5).
* Women of childbearing potential must test negative for pregnancy prior to study enrolment.
* Sexually active females of childbearing potential are required to use adequate contraceptive methods during the study period and until completion of the follow-up procedures. No specific contraceptive measures are required in male subjects during study participation.

Exclusion Criteria:

* Subjects who have been discontinued due to protocol violation(s) (as determined by the Sponsor) in the A3921084 study.
* Subjects who were discontinued from the A3921084 study due to an adverse event.
* Subjects likely to require any non-elective surgery or surgery requiring overnight stay (with the exception of minor same day outpatient procedures that will not interfere with study drug dosing).
A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms

Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. There is an unmet medical need for effective treatment in pediatric patients and this study is being done to evaluate risankizumab in pediatric participants with moderate to severe plaque psoriasis. This study will assess the change in disease symptoms.

Risankizumab is a drug being studied for the treatment for plaque psoriasis in pediatric participants. This study has 4 parts.

Part 1: Participants aged 12 \< 18 will receive a fixed dose of risankizumab. Part 2: Participants aged 12 \< 18 will receive;

* Period A: Risankizumab or ustekinumab based on body weight followed by;
* Period B: Risankizumab or no treatment.
* Period C: Re-treatment with risankizumab (if needed).

Part 3: Participants aged 6 \< 12 will receive risankizumab based on body weight.

Part 4: Participants aged 6 \< 12 will receive risankizumab based on body weight (Japan only: Participants aged 12 \> 18 will receive risankizumab based on body weight).

Around 132 participants will be enrolled in approximately 50 sites worldwide.

Risankizumab and ustekinumab are given as a subcutaneous (under the skin) injection.

Parts 1, 3, and 4: Risankizumab for 40 weeks with a follow-up call 20 weeks later for a study duration of approximately 65 weeks.

Part 2:

* Period A: Risankizumab or ustekinumab for 16 weeks.
* Period B: Risankizumab or no treatment for 36 weeks.
* Period C: Re-treatment with risankizumab for 16 weeks. Follow-up call 20 weeks later for a study duration of approximately 81 weeks. Participants from each Part who meet eligibility criteria for an open-label extension (OLE) study may continue on risankizumab for 216 additional weeks.

There may be a higher burden for study participants compared to standard treatment. Participants will attend monthly visits and medical assessments will check the effect of treatment through blood tests, questionnaires, and checking for side effects.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic plaque psoriasis for at least 6 months before the Baseline Visit.
* Stable severe or moderate to severe plaque psoriasis as defined in each study part by body surface area (BSA) psoriasis involvement and scores on the Psoriasis Area and Severity Index (PASI) and Static Physician Global Assessment (sPGA).
* Candidate for systemic therapy as assessed by the investigator and meet the disease activity criteria at both the Screening and Baseline Visits per the protocol.

Exclusion Criteria:

- Concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the participant's participation in this study, would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk by participating in the study.