cyrilzakka/clinical-trials huggingface dataset:
Lifestyle Intervention for Improving Insulin Resistance and Concern for Health

The primary objective of this study is to test the effect of a diet and exercise program in older adults with insulin resistance and a motivation disorder known as apathy. The main questions the study aims to answer are:

1. Does the diet and exercise program improve insulin resistance and apathy?
2. Does the addition of soybean to the diet enhance the effect? Participants will be given all meals for 12 weeks and will exercise under supervision. They will undergo a test of insulin sensitivity and complete questionnaires.

Researchers will compare the groups given:

1. A diet to moderate the blood glucose response that contains soybean; and
2. A diet to moderate the blood glucose response that does not contain soybean.

This randomized trial will examine the blood glucose moderating effect of a diet and exercise program in 40 older adults with obesity, insulin resistance, and apathy. The primary objective of this study is to examine the effect of a diet and exercise program on insulin sensitivity and apathy and determine if the addition of soybean to the diet enhances the effect. The primary outcomes of the study are insulin sensitivity measured using the hyperinsulinemic euglycemic clamp test and apathy evaluated using the Apathy Evaluation Scale.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) greater than or equal to 30kg/m2
* Mini-Mental State Examination (MMSE) \> 25
* Geriatric Depression Scale-15 (GDS-15) \< 6
* Apathy Evaluation Scale - score \> 30 or GDS-15 Apathy subscale - score ≥ 2
* Homeostatic model assessment of insulin resistance (HOMA-IR) ≥ 3
* Sedentary: \< 90 minutes of moderate to vigorous physical activity/week.

Exclusion Criteria:

* Subjects with a diagnosis of Type 2 diabetes received more than five years ago.
* Participants who have type 1 diabetes
* Participants being treated with prescription or over the counter medications that have a significant effect on insulin resistance, obesity, high density lipoprotein cholesterol, triglycerides, metabolic rate and those that significantly increase body weight.
* Participants who are on concomitant therapy with glucocorticoids.
* Participants with evidence and/or history (within the preceding 6 months) of significant gastrointestinal dysfunction.
* Participants that have had a fluctuation in body weight \>5% in the preceding 2 months.
* Any other conditions that may impede testing of the study hypothesis.
Effect of Vitamin D Supplementation on the Efficacy and Adverse Effects of Neoadjuvant Therapy in Patients with Breast Cancer

This randomized controlled Phase III trial was designed to evaluate the impact of supplemental vitamin D (VD) on the efficacy and side effects of neoadjuvant therapy in patients with breast cancer.

This is a parallel-group, open-label randomized controlled trial designed to investigate the effects of supplemental vitamin D (VD) on the outcomes and side effects of neoadjuvant therapy in patients with breast cancer. Both groups will receive standard neoadjuvant therapy on day 1 and for each subsequent cycle. Additionally, vitamin D2 will be randomly administered to both groups.Blood samples and imaging results will be collected and analyzed prior to the initiation of neoadjuvant therapy and after every two cycles. Key outcomes to be recorded include the pathological complete response rate (pCR), objective response rate (ORR), disease control rate (DCR), and grade III or higher adverse effects related to neoadjuvant therapy. The primary and secondary study findings, along with adverse events, will be thoroughly evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 80 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
2. Primary diagnosis of breast cancer confirmed by preoperative pathological examination.
3. Serum 25(OH)D levels less than 20 ng/ml (50 nmol/L).
4. Patients who have not previously received chemotherapy and who plan to undergo at least 4 cycles of 5.neoadjuvant chemotherapy or combined targeted therapy.

6.Life expectancy of at least 6 months. 7.No other uncontrolled benign diseases at the time of recruitment. 8.All patients must have complete clinical medical records. 9.Willingness to voluntarily sign an informed consent form.

Exclusion Criteria:

1. History of invasive breast cancer.
2. Prior systemic treatment for the treatment or prevention of breast cancer.
3. Known allergic reactions to vitamin D or calcium compounds.
4. Comorbidities that may affect vitamin D or calcium balance or bone health.
5. Vitamin D or calcium supplementation in the past 3 months.
6. Presence of other tumors.
7. Pregnant or lactating women.
8. Individuals who do not wish to participate in the study.
Effectiveness of Golimumab in Patients With Ulcerative Colitis: Results of a Real-life Study in Switzerland

TNF inhibitors have improved treatment options for patients with inflammatory bowel disease (IBD) and three TNF inhibitors, infliximab, adalimumab and golimumab are available for treatment of ulcerative colitis in Switzerland. However, these drugs have been tested under ideal conditions in randomized controlled trials. Real-world data are needed to complement this information. It is the aim of the investigators to study, whether patients with ulcerative colitis can be effectively treated with golimumab in a real world setting in Switzerland.

The investigators used data from the Swiss IBD cohort study (SIBDC) in Switzerland and identified all SIBDC patients with UC treated with Golimumab and performed a retrospective chart review. The investigators acquired patient reported outcomes and objective measures for inflammation at baseline, at 6-10 weeks and at 6 and 12 months after golimumab treatment. Primary endpoint was clinical response (i.e. meaningful improvement) at 6-10 weeks. Secondary endpoints were clinical response at 6 and 12 months and clinical remission (i.e. free of symptoms of disease).

Ulcerative colitis patients from the Swiss IBD cohort study treated with golimumab were identified. The investigators performed a retrospective chart review and assessed patient reported outcomes and objective measures of inflammation to assess response and remission.

As clinical response in UC the investigators defined a composite end point of: Marked improvement in partial Mayo score AND improvement in one or more of the following parameters (acquired during chart review):

* Endoscopy data
* Ultrasonography
* Calprotectin (cut off 100microg/g)
* CRP
* Anemia resolution

Marked improvement was defined as: Clinical response based on partial Mayo Score (including physician global assessment): decrease in partial Mayo score ≥ 2 points and ≥ 30% from baseline and a decrease in rectal bleeding subscore ≥ 1 point or absolute rectal bleeding score ≤ 1. Improvement in lab work was defined as a reduction of the difference between baseline values and the next limit of normal by ≥ 30%. Improvement in endoscopy/ ultrasonography was defined as a reduction of colitis in the same technique compared to baseline substantiated by images (endoscopy) or measurements of diameter of the bowel wall.

As clinical remission in UC we defined normalization (i.e. absence of pathology) of patient reported outcomes (Frequency of stool, blood in stool) AND no evidence of residual disease activity in all of the following parameters:

* Endoscopy data
* Ultrasonography
* Calprotectin (cut off 100microg/g)
* CRP and anemia

Eligibility Criteria:
Inclusion Criteria:

* Patient of the Swiss IBD cohort study
* Diagnosis of ulcerative colitis
* Past treatment with golimumab (at least one dose)

Exclusion Criteria:

* none
Biodex Sit2Stand for Individuals With Cardiac Disease

Patients with cardiac disease have been shown to have deficits in activities such as standing up from a chair. The Biodex Sit2Stand Trainer is a new device meant to improve sit to stand performance by providing a lifting force through the seat to help the individual stand. The amount of lift can be graded to help improve leg strength, endurance, and function over time. The device has the potential to be a form of training for those in cardiac rehabilitation who have limitations in standing from a chair.

Patients who are diagnosed with cardiovascular disease and enter cardiac rehabilitation present with limitations in activity and restrictions in their abilities to participate in society. Even after a standard course of cardiac rehabilitation, some individuals will still present with deficits. One area this is seen is the ability to stand up from a chair. A new device, the Biodex Sit2Stand Trainer, has been designed to help improve the standing movement in those with lower extremity weakness. The trainer provides a graded lift or push through the seat to help the participant reach a standing posture. This study will whether a six week training program using the trainer will lead to improvements in strength, function and quality of life for those individuals who have recently completed a cardiac rehabilitation program. This study is a pilot study to help determine the ideal dosage of training and identify any limitations in using the device with this population. Based on the results of this pilot work, a larger intervention study will be conducted to examine the effectiveness of the trainer in a cardiac rehabilitation program.

Eligibility Criteria:
Inclusion Criteria:

Individuals nearing the end of their cardiac rehabilitation program will be asked to participate. Inclusion criteria include the following:

* Completion of a cardiac rehabilitation
* Ability to walk 50 feet independently with or without an assistive device
* Inability to stand from a standard chair five times without the use of their arms or unable to complete five sit to stands in less than 15 seconds.
* No major cardiac arrhythmias during cardiac rehabilitation sessions.
* Ability to attend 14 sessions over a 7-8 week period

Exclusion Criteria:

* Not meeting inclusion criteria
Dual Diagnosis Self-Help Referral

This project will help counselors in substance abuse treatment programs make effective referrals of dually diagnosed patients (those with a co-occurring psychiatric disorder) to self-help groups.

Background:

Dual diagnosis (psychiatric and substance use) patients' (DDPs) participation in 12-step mutual-help groups is linked to lower relapse and treatment utilization rates. However, under usual referral, many DDPs do not attend, or sustain attendance of, substance-focused groups (SFG). DDPs may benefit from dual-focused groups (DFGs).

Objectives:

(1) Implement and validate procedures to help counselors make effective referrals to DFGs. DDPs were assigned to a standard- or intensive-referral to DFG condition to determine the extent to which intensive referral, compared to standard referral, increased patients' mutual-help group participation. (2) Determine whether DDPs who received intensive referral had better substance use and psychiatric outcomes.

Methods:

DDPs entering VA outpatient mental health treatment received either standard (N=145) or intensive (N=142) referral. Standard referral consisted essentially of the counselor recommending DFG participation. The keys to intensive referral were a DFG orientation and the counselor facilitating direct contact between the patient and a DFG member, and following up on recommendations for mutual help. Patients were followed at six months (80%), one year (81%) and two years (80%) to determine whether intensive referral resulted in more DFG and SFG participation, and better substance use and psychiatric outcomes.

Status:

Completed.

Eligibility Criteria:
Inclusion Criteria:

* Dually diagnosed veterans entering outpatient mental health treatment

Exclusion Criteria:

* Unable to correctly answer the Orientation and Registration questions of the Mini-Mental State Examination
Yoga Intervention Study on Episodic Tension Type Headache

The present study was designed to evaluate effect of yoga intervention on patients having frequent tension type headache.


Eligibility Criteria:
Inclusion Criteria:

* aged between 18 to 60 years
* more than 5 but fewer than 15 headache episodes per month
* headache intensity moderate to severe

Exclusion Criteria:

* Patients on anti-psychotic, antidepressant or any prophylactic medication
* pregnancy
* Taking psychotherapy or any other alternative medicine
* migraine headache more than 1 day a month
* pain disorder, psychiatric or medical disorder requiring immediate treatment,
* headache due to sinusitis, eyestrain, cervical spondylosis and posttraumatic headaches
The Newborn Project: Examining the Oxygenation of Brain Tissue During General Anesthesia

This study will be an observational, prospective trial that will measure the cerebral oxygenation of infants scheduled to undergo general anesthesia at Boston Children's Hospital.

Data will be collected from the Near Infrared Spectroscopy (NIRS) monitor and the patient's medical record. When the NIRS sensor is attached to the patient's forehead the oxygenation of brain tissue will be continuously monitored. All other information will be routinely recorded as standard clinical care and this information will be obtained from the patient's medical record. The NIRS monitor data will by time synched to the anesthesia record and downloaded to a secured password protected file.

In the post-operative period, patient data will be collected including: 1) any skin findings related to the placement of the NIRS or pulse oximetry probes 2) any unanticipated need for hemodynamic support, 3) laboratory values including hemoglobin levels, electrolytes, and blood gases, 4) new neurological findings (seizures etc.)

Eligibility Criteria:
Inclusion Criteria:

* Children less than 6 months of age
* Undergoing a scheduled or emergent procedure with anesthesia at Boston Children's Hospital

Exclusion Criteria:

* Placement of NIRS sensor that will interfere with surgery
* Child has an allergy to medical grade adhesives or pre-existing skin irritation at the sensor site
* Scheduled for a cardiac procedure
* Patient's care team or patient's family declines participation
* American Society of Anesthesiologists (ASA) criteria of IV or greater
* Infants who are being treated with sympathomimetic medications intraoperatively
Osteogenesis Imperfecta (OI) Quality of Life Survey Pilot Project 2

The purpose of this study is to explore the patient perspective of disease burden in Osteogenesis Imperfecta (OI). Participants will complete a web-based survey of questions which are usually administered within the Patient-Reported Outcome Measurement Information System (PROMIS) and provide feedback regarding the appropriateness of the questions for someone with OI.

Participants will be recruited through the RDCRN BBD Contact Registry. An email invitation will be sent to all RDCRN BBD Contact Registry participants that meet the inclusion criteria to complete the online PROMIS CAT instruments. The email invitation will contain a link to the informed consent form. Once participants have consented to the study, they will have access to the online instruments. Follow-up emails will be sent to participants that have not completed any of the instruments. Reminder emails will be sent to participants with partially completed instruments.

Data will be collected and stored by the RDCRN DMCC at USF.

Data from patients co-enrolled in the "Longitudinal Study of Osteogenesis Imperfecta" and the BBD RDCRN Contact Registry will be linked and compared. Additional disease specific information will be collected by the survey (e.g., information on OI type and diagnosis, height, number of fractures, concurrent medication use, utilization of any mobility aid, hearing aid, or other device that they may use.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in the RDCRN BBD Contact Registry English speaking Age 2 to adult

Exclusion Criteria:

* Inability to provide informed consent Inability to complete instruments
Effects of Compression Wear on Muscle Soreness

The study address two main topics:

1. The effect of compression garment on whole-body electromyostimulation (WB-EMS) induced muscle soreness in young adults
2. The repeated bout effect of one intense session of WB-EMS as determined by various regeneration parameters

Using a cross-over design we applied 2 intense WB-EMS training sessions either with or without subsequent wearing of compression garments (long tights) for 5 days at baseline and after a washout period of 4 weeks. Healthy young to middle aged athletes used compression garments immediately postexercise for 24 hours and further 12 h during the day. Blood samples, questionnaires, resting metabolic rate and performance test were applied prior and 24, 48,72 and 96 h post-exercise consistently without wearing compression garments.

Eligibility Criteria:
Inclusion Criteria:

* healthy athletes with \>5 years of experience in competition balls sports and corresponding discipline specific resistance exercise

Exclusion Criteria:

* diseases and medication affecting muscle metabolism
* contraindication for WB-EMS
PACE30: 30 Years in Cardiac Pacing

Limited data exist regarding temporal trends in permanent pacemaker (PPM) implantation. To describe trends in incidence and comorbidities of PPM recipients, the investigators aim to conduct a retrospective population-based cohort study using record linkage, over a 32 year period.


Eligibility Criteria:
Inclusion Criteria:

* All patients with pacemakers
Comparison of the Efficacy of Irrigation With Epinephrine or Tranexamic Acid on Visual Clarity

The primary aim of this report is to determine whether there is a difference between Epinephrine and Tranexamic acid in providing visual clarity during arthroscopic rotator cuff tear repair.


Eligibility Criteria:
Inclusion Criteria:

* • Age \> 18 years

  * American Society of Anesthesiologist Physical Status Classification System : 1-2
  * Undergoing a full arthroscopic double-row repair due to full-thickness cuff tear
  * Being willing to participate the study

Exclusion Criteria:

* • Age \< 18 years

  * American Society of Anesthesiologist Physical Status Classification System ≥3
  * Concomitant cardiac diseases
  * Concomitant bleeding disorder or coagulopathy
  * Diabetes mellitus
  * Being pregnant
  * Use of contraceptive pills
  * A history of previous shoulder surgery
  * Uncontrolled hypertension during the operation (\>180/110 mm Hg)
  * Unrepairable rotator cuff tears
  * Being unwilling to participate the study
A Prospective Clinical Study to Assess the Clinical Utility of Turbidity in Patients Using In-Home Peritoneal Dialysis

This study aims to determine if the CloudCath device can detect infections related to peritoneal dialysis (peritonitis) as fast or faster than the current standard methods used by patients and doctors to detect such infections.

This study will evaluate the safety and effectiveness of the CloudCath System to detect the onset of peritonitis as compared to standard of care.

Study Participants will connect the CloudCath System to their home peritoneal dialysis unit and the CloudCath System will analyze the effluent dialysis solution for changes associated with peritonitis. The system will alert the participant and healthcare provider if it detects a possible infection so they can be formally diagnosed by their healthcare provider.

Following enrollment, Study Participants will use the CloudCath System for 12 continuous months.

Study results from the ACT study will be compared to the results of the CATCH Study (Protocol number CC-P-001; NCT04515498). In CATCH, the Study Participants used a CloudCath System; however, the notification capabilities (per the CloudCath System algorithm) were deactivated.

Eligibility Criteria:
Key Inclusion Criteria:

* currently using peritoneal dialysis
* provides informed consent
* willing to comply with the requirements of the study
* has cellular data coverage at home

Key Exclusion Criteria:

* active or history of cancer requiring chemotherapy within prior 6 months
* signs or symptoms of an active infection within 14 days prior to enrollment
* peritonitis diagnosis within 30 days prior to enrollment
* participating in another investigational device or drug study that may potentially affect study results
* other medical, social or psychological problems that, in the opinion of the investigator, exclude the study participant from the study
Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects

The primary objective of this Phase I exploratory study is to determine the effects of mipomersen on the hepatic production of apolipoprotein-B (apo B) in very low density lipoprotein (VLDL) compared to baseline levels. The study will consist of a Screening Period, a 1-week Run-in Period to establish a stable diet, an approximate 11-week Treatment Period with Placebo or Mipomersen, and a 25-week Post-Treatment Follow-up Period. The total duration of any given subject's participation will be approximately 40 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant, non-lactating, surgically sterile, postmenopausal, abstinent, or the subject or partner is compliant with an acceptable contraceptive regimen for 4 weeks prior to Screening and willing to remain compliant with the contraceptive regimen throughout treatment and for 25 weeks after the last investigational product dose
* Body weight \>50 kg, body mass index (BMI) ≤38 kg/m2, and stable weight (i.e., within 5% of mean body weight) for \> 8 weeks prior to Screening
* Fasting TG levels of ≤170 mg/dL, fasting serum blood glucose of ≤115 mg/dL, and an HbA1c ≤6.5%

Exclusion Criteria:

* Presence of any clinically significant abnormal laboratory profiles, physical exams, vital signs, or ECGs
* History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, infectious, or psychiatric disease
* Malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for \>1 year) at Screening
* History of relevant food and/or drug allergies (i.e., allergy to heparin or any significant food allergy that could preclude a stable diet)
* The subject is receiving prescription lipid-lowering therapies such as statins, bile acid sequestrants, niacin/nicotinic acid, and/or fibrates or over-the-counter (OTC) fish oils, flaxseed, red rice or nutrient supplements that might affect lipid levels
* The subject is unwilling to limit alcohol consumption for the entire duration of the study
* The subject smokes \>5 cigarettes per day
Extension Block Technique Versus Splinting in Mallet Finger Fracture.

Mallet finger is an avulsion of the extensor tendon at its insertion on the base of the distal phalanx, with or without fracture.

Treatment af mallet finger fractures involving more than 1/3 of the articulating surface is controversial. There are to our knowledge no randomized controlled trials comparing splinting and surgical treatment with extension block technique.

The aim of this study is to compare splinting and surgical extension block fixation of mallet finger fractures in a randomized controlled trial.Our hypothesis is that conservative treatment with splinting is comparable to surgical treatment concerning functional outcome, and may even reduce the complication rates.

The original protocol was designed to include participants with non-subluxated and subluxated mallet finger fractures. However this study only included participants with non-subluxated fingers.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Mallet finger fractures with a \>1mm displaced fragment involving one-third or more of the articular surface and/ or subluxation of the distal phalanges.
* Fractures with a delay of \< 2 weeks.
* With reference to Wehbé and Schneider's established classification, fractures type IB and IC are included.

Exclusion Criteria:

* Open injuries
* Mallet finger fracture of the thumb
* Co-existing rheumatologic illness in the fingers
* No-compliance patient