cyrilzakka/clinical-trials huggingface dataset:
A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC

The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan, and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected pancreatic ductal adenocarcinoma (PDAC) who have not received prior systemic anti-cancer treatment for PDAC and have no evidence of disease after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of PDAC
* Pancreatic cancer tumor, lymph node, metastasis (TNM) pathological staging values of T1-T3, N0-N2, and M0 per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual
* Macroscopically complete (R0 or R1) resection of PDAC
* Unequivocal absence of disease after surgery as assessed by the investigator within 28 days prior to randomization
* CA19-9 level measured within 14 days prior to initiation of study treatment
* Interval of between 6 and 12 weeks since resection of PDAC
* Full recovery from surgery and ability to receive atezolizumab, autogene cevumeran, and mFOLFIRINOX in the investigator's judgment
* Adequate hematologic and end-organ function
* Female participants of childbearing potential must be willing to avoid pregnancy during the treatment period and for 28 days after the final dose of autogene cevumeran, for 9 months after the last dose of chemotherapy, and for 5 months after the final dose of atezolizumab. They must refrain from donating eggs for 9 months after the last dose of chemotherapy.
* Male participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use specified contraceptive methods during the treatment period and for 28 days after the final dose of autogene cevumeran and for 6 months after the last dose of chemotherapy. Men must refrain from donating sperm during this same period.

Exclusion Criteria:

* Prior adjuvant, neoadjuvant, or induction treatment for pancreatic cancer
* Plan for further adjuvant anti-cancer therapy for PDAC (e.g., radiotherapy and/or chemotherapy), not mandated per protocol, to be initiated after completion of mFOLFIRINOX treatment
* Absence of spleen; distal pancreatectomy with splenectomy is exclusionary
* Preexisting Grade \>/=2 neuropathy
* Known complete dihydropyrimidine dehydrogenase (DPD) deficiency including homozygous or compound heterozygous mutations of DPYD genetic locus associated with DPD deficiency
* Disorders of the colon or rectum, or postoperative complication leading to Grade \>/=2 diarrhea
* Pregnancy or breastfeeding
* Active or history of autoimmune disease or immune deficiency
* Treatment with brivudine, sorivudine, or their chemically-related analogues, which are inhibitors of DPD, within 4 weeks prior to initiation of study treatment
* Current or planned treatment with strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) and/or uridine diphosphate glucoronosyltransferase 1A1 (UGT1A1).
24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared With Acarbose When in Combination With Metformin in Patients With T2D Inadequately Controlled With Metformin Monotherapy

SMART Study - A 24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared with Acarbose when in Combination with Metformin in Patients with Type 2 Diabetes Mellitus (T2D) Inadequately Controlled with Metformin Monotherapy


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with type 2 diabetes mellitus
2. Men and women (non-pregnant and using a medically approved birth-control method) aged at least 18 years at screening.
3. T2D patients treated with stable metformin monotherapy for at least 8 weeks prior to screening. Metformin dose should be ≥ 1500 mg/day (or individual maximally tolerated dose), but not more than the maximum dose specified in the label
4. HbA1c ≥ 7.5% and ≤ 11.0% at screening or within 4 weeks prior to screening (by local laboratory) and HbA1c ≥ 7.0% and ≤ 11.0% at pre-randomization visit (by central laboratory)
5. FPG ≤ 13.3 mmol/L (≤ 240 mg/dL) at pre-randomization visit (by central laboratory)
6. Able and willing to provide written informed consent and to comply with the study protocol

Exclusion Criteria:

1. Women who are pregnant, intending to become pregnant during the study period, lactating females, or women of child-bearing potential not using highly effective, medically approved birth control methods.
2. Diagnosis or history of:

   1. Type 1 diabetes mellitus, diabetes resulting from pancreatic injury or secondary forms of diabetes, eg, acromegaly or Cushing's syndrome.
   2. Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months.
3. Previous treatment with any dipeptidyl peptidase-4 (DPP4) inhibitor or GLP-1 receptor agonists within the past one year.
4. History of hypersensitivity reaction (e.g., anaphylaxis, angioedema, exfoliative skin conditions) to dipeptidyl peptidase-4 inhibitor (DPP4) or Acarbose.
5. Treatment with any anti-diabetic medication for more than 7 consecutive days other than metformin in the last 8 weeks prior to screening
Sitagliptin for the Treatment of Non-alcoholic Steatohepatitis in Patients With Type 2 Diabetes

This is a randomized, double-blind, placebo-controlled trial evaluating the impact of sitagliptin therapy in patients with concomitant type 2 diabetes and non-alcoholic steatohepatitis (NASH) on improving liver disease based on biopsy results. The effect of sitagliptin on other measures such as hormones modifying insulin release and sensitivity (termed adipocytokines), fat distribution, and biomarkers of cardiovascular risk will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Known DM2 (receiving lifestyle management and/or metformin and/or sulfonylurea
* Stable therapy for DM2 for the past 3 months
* All other medications and doses stable for past 3 months
* HbA1c 8.9% or lower (can be done in past 30 days)
* Known NASH based on the accepted American Gastroenterological Association Criteria:

  1. Alcohol consumption (\< 10g/day in women and \<20g/day in men)
  2. Cause of liver disease other than NAFLD (negative investigations for: viral hepatitis, iron overload, a-1 antitrypsin, ceruloplasmin, autoimmune disease)
  3. Liver histology demonstrating macrovesicular fatty change of hepatocytes, with evidence of steatohepatitis, manifested by the presence of Mallory Bodies, ballooning degeneration, lobular neutrophilic inflammation and perisinusoidal fibrosis. (If liver biopsy done within 2 years prior to screening for this trial, that biopsy will be reviewed to ensure it meets criteria for diagnosis).

Exclusion Criteria:

* Any contraindication for undergoing MRI
* Child class B or C cirrhosis
* Participation in another clinical trial
* Use of thiazoledinedione (rosiglitazone or pioglitazone) in past 6 months
* Current use of plavix
* Previous exposure to sitagliptin
* Prior history of pancreatitis
* History of anaphylaxis to another Canadian-marketed DPP-IV inhibitor (saxagliptin)
* Creatine clearance \<30 ml/min
* Anaemia (haemoglobin \< 110 mg/dL)
* Platelet count \< 50 000 cells/mm3
* Known heart or kidney failure
* Comorbid condition that decreases natural life span (e.g. known cancer)
* Pregnant or breastfeeding or wishing to become pregnant in the next 6 months
* Current or past treatment with medications that can induce steatohepatitis (e.g. glucocorticoids, methotrexate, amiodarone etc.)
The Effectiveness of a Bacteriophobic Coating on Urinary Catheters

To assess if a bacteriophobic coating prevents biofilm and host protein accumulation on urinary catheters and inflammatory protein release in urine following catheterization

The purpose of the study is to provide pilot information on the characteristics of the biofilm formed on the coated catheter compared to a standard catheter. The two objectives are;

1. to evaluate the catheter's on-label performance in customary clinical use.
2. to quantify biofilm formation on the catheter surface, and to compare it with biofilm formation on the hospitals current uncoated catheters.

Eligibility Criteria:
Inclusion Criteria:

1. All patients undergoing colorectal resection routinely requiring a urinary catheter as part of their standard post-operative care.
2. Patients aged 18-85 years will be eligible for the study.
3. Able to give informed consent.

Exclusion Criteria:

1. Patients that have or recently (within 3 weeks) had a urinary catheter, or those with signs of current urinary tract infection.
2. Pregnant patients.
3. Patients with a potentially immunocompromised condition (steroids, HIV)
4. Patients who are unable to give informed consent
The Application of Sling Exercise Training in People With Chronic Stroke

The purpose of this single-blinded, randomized controlled study aims to investigate the effects of sling exercise training (SET) for core muscle on gait performance in people with chronic stroke.

Background and purpose: Balance and gait performance are often impaired in people post stroke. Evidence showed positive correlations between trunk control and balance and walking ability. Previous studies applying core muscle training reported positive effects on improving trunk control and sitting balance among patients with chronic stroke, but benefits on standing balance and gait performance remain undetermined. Sling exercise training (SET) has been suggested for improving core muscle stability and strength in people with stroke. However, studies about effects of SET on gait performance in stroke populations are limited. Therefore, the present study aims to investigate the effects of SET for core muscle on gait performance in people with chronic stroke.

Methods: Thirty-eight individuals with chronic stroke will be recruited and assigned to one of the two groups by randomization, sling exercise training group and conventional training group. The training is 30 minutes per session, 3 sessions per week for total of 4 weeks. Gait performance is the primary outcome to include gait speed, stride length, single leg support time and temporal and spatial symmetry measured by GAITRite® System. Secondary outcomes include balance, timed up-and-go (TUG) test and trunk performance. All outcomes will be assessed before, after the 4-week training program and at 4-week follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Stroke after onset ≥ 6 months
* Trunk impairment scale (TIS) score ≤ 21 at baseline
* Brunnstrome stage ≥ IV over the affected lower extremity
* Ability to independently walk for 10 meters with or without assistive devices
* Intact cognition with mini-mental state examination (MMSE) ≥ 24

Exclusion Criteria:

* Any other significant musculoskeletal disorder, neurological disease or cardiovascular disease that may affect the participation in this study.
* Vision or language deficit that may affect participating in this study.
Delta Healthy Sprouts: Intervention to Promote Maternal Weight Control and Reduce Childhood Obesity in the MS Delta

The Delta Healthy Sprouts Project is a randomized, controlled trial evaluating the enhancement of an existing Mother, Infant, and Early Childhood Home Visiting Program in 150 African American women in their early second trimester of pregnancy. The control arm, Parents as Teachers, is an evidence-based approach to increase parental knowledge of child development and improve parenting practices. The experimental arm, Parents as Teachers Enhanced, builds on the Parents as Teachers curriculum by including nutrition and physical activity components specifically designed for the gestational and postnatal periods. Both arms of the intervention will be implemented by community-based, trained Parent Educators. The comparative effectiveness of the two intervention arms on weight status, dietary intake, and health behaviors of mothers and their infants will be assessed. The Delta Healthy Sprouts Project will determine if a novel, scalable, lifestyle intervention can improve the health of African American women and their children at high-risk for obesity and chronic disease.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Less than 18 weeks pregnant with first, second, or third child
* Resident of Mississippi counties of Washington and Bolivar

Exclusion Criteria:

* Pregnant with more than one fetus
A Study to Evaluate the Effect of Vildagliptin on the Maximum Insulin Secretion in Patients With Type 2 Diabetes

Type 2 diabetes results when the body does not produce enough insulin to regulate blood sugar. This study is designed to measure the effect of vildagliptin on the maximum insulin secretion by the pancreas.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes for at least 6 months
* Patients whose diabetes is controlled by diet and exercise only or patients taking metformin
* BMI in the range 22-45
* Blood glucose criteria must be met

Exclusion Criteria:

* Pregnancy or lactation
* Type 1 diabetes or diabetes resulting from pancreatic injury
* Cardiovascular complications as defined by the protocol
* Significant diabetic complications as defined by the protocol

Other protocol-defined inclusion/exclusion criteria may apply
Study to Examine Lesions of the Skin Using Confocal Laser Microscopy

Using ex-vivo confocal laser scanning microscopy, a reliable statement can be made about the extent, histological structure and possible significance of a skin change without having to send tissue samples for demanding and lengthy histological examinations.

Using ex-vivo confocal laser scanning microscopy, a reliable statement can be made about the extent, histological structure and possible significance of a skin change without having to send tissue samples for demanding and lengthy histological examinations.

Eligibility Criteria:
Inclusion Criteria:

* Patients with benign and malignant skin tumors

Exclusion Criteria:

* Patients unable to consent
Support and Tracking to Achieve Results (Project STAR)

The investigators propose to conduct a randomized controlled trial assessing the impact of phone-based extended care delivered on an ADAPTIVE (when participants are at "high risk" for weight regain as assessed by a predictive algorithm) vs. STATIC (gold-standard, once-per-month frequency) schedule on weight loss maintenance. The study team will provide participants with an initial behavioral weight management program, and then randomize participants who successfully achieve a clinically-significant weight loss of ≥5% to one of the two extended-care conditions

Obesity remains a substantial public health challenge in the United States. While behavioral lifestyle interventions have been demonstrated to produce weight losses of 8-10% in adults with overweight and obesity, long-term outcomes are suboptimal, limiting effectiveness for long-term weight loss maintenance.

The study team will evaluate methods for providing phone-based extended-care to support weight loss maintenance. The investigators propose to conduct a randomized controlled trial assessing the impact of phone-based extended care delivered on an ADAPTIVE (when we determine that participants are at "high risk" for weight regain) vs. STATIC (once-per-month frequency used in gold-standard extended-care programs) schedule on weight loss maintenance. Participants will be provided with an initial in-person, group-based behavioral weight management program. Participants who successfully achieve a clinically-significant weight loss between baseline and Month 4 (defined by the Institute of Medicine as a reduction in weight of ≥ 5% from baseline) will be randomized into the clinical trial. Follow-up visits will occur at Month 12 and Month 24 after initial intervention baseline.

Eligibility Criteria:
Inclusion Criteria:

* BMI 30.0-45.0 kg/m2
* Own a smartphone \[Apple iPhone (5s or newer) or Android smartphone (KitKat OS 4.4 or newer)\] with a cellular and data plan
* Weight ≤ 396 pounds (due to scale limit)
* Lose ≥ 5% of baseline weight during the initial weight loss intervention (Month 0 to Month 4)
* Completion of baseline assessment measures

Exclusion Criteria:

* History of bariatric surgery
* Current use of weight loss medications
* Weight loss of ≥ 10 lb in prior 6 months
* Physical limitations that prevent walking ¼ mile without stopping
* Use of a pacemaker
* Currently pregnant
* Currently breastfeeding
* Less than 1 year post-partum
* Plans to become pregnant within the study period
* Lack of written approval for participation from potential participant's physician if the participant has been diagnosed with type 2 diabetes, hypertension, or has a history of coronary heart disease
* More than one participant per household (enrollment limited to one participant per household)
* Medical conditions that contraindicate weight loss or prevent completion of the study (e.g., current diagnosis of cancer or terminal illness, dementia, or plans to relocate during the study period)
A Multicenter, Double-Blind, Phase III, Adjuvant-Controlled Study of the Effect of 10 Units of HIV-1 Immunogen (Remune) Compared to Incomplete Freund's Adjuvant (IFA) Alone Every 12 Weeks on AIDS-Free Survival in Subjects With HIV Infection and CD4 T-Lymphocytes Between 300 and 549 Cells/microL Rega

To determine the effect of HIV-1 immunogen (Remune) on AIDS-free survival, defined as the time prior to development of an AIDS-defining condition or death.

Patients receive 10 units of HIV-1 immunogen in IFA or IFA alone every 12 weeks, then are followed for 104-148 weeks.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Antiretrovirals if on a stable dose for at least the past 3 months.

Patients must have:

* HIV-1 infection with CD4 count 300-549 cells/mm3.
* No AIDS-defining condition.
* Been on a stable dose of antiretroviral for the past 3 months, if taking antiretrovirals.

NOTE:

* KS is permitted if not requiring systemic therapy.

Prior Medication:

Allowed:

* Prior antiretrovirals.

Exclusion Criteria

Concurrent Medication:

Excluded:

* Systemic chemotherapy for KS.
* Treatment for malignancy other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.

Patients with the following prior conditions are excluded:

* History of any illness that would interfere with study.
* Acute infection requiring prescription therapy within the past month, other than genital herpes and oral or vaginal candidiasis.

Prior Medication:

Excluded:

* Prior HIV-1 Immunogen. Unwilling to use effective safe sex practices. Active substance abuse.
FitJoints: Getting Fit for Hip and Knee Replacement

Total hip or knee replacement is an important and cost-effective surgical intervention to relieve pain and improve independence and function in patients with osteoarthritis. The number of people waiting for elective surgeries has spiked in the COVID-19 pandemic. Prior to COVID-19, up to 40% of patients receiving joint replacement were frail and this number is rapidly increasing with longer wait-times and deconditioning associated with COVID-19 physical distancing. There is an urgent need to be responsive to the evolving challenges of healthcare. The proposed study is the first multi-site randomized controlled trial (RCT) to examine whether a multimodal frailty reduction intervention before surgery will improve postsurgical outcomes for this population. The COVID-19 adapted hybrid model includes a multimodal frailty intervention that may be implemented either in person or virtually and is aligned with international consensus guidelines on frailty reduction.

To utilize the FitJoints multimodal frailty intervention to build resilience of patients undergoing joint replacement surgery to improve post-operative outcomes. The investigators hypothesize the FitJoints multimodal frailty intervention, with exercise, nutrition and medication optimization, will reduce frailty and pain while improving function and quality of life.

Building upon the success of the FitJoints feasibility study (n=69) in Hamilton, Ontario, in the proposed multi-site RCT (n=192), older adults (≥60 years) undergoing hip or knee joint replacement surgery who are frail will be randomized to either the 3 to 6-months of multimodal intervention or usual care until the date of their surgery at multiple sites (Hamilton Health Sciences \& St Joseph's Healthcare Hamilton, ON; London Health Science Centre, London, ON; Foothills Hospital, Calgary, AB),The FitJoints evidence-based, multimodal intervention includes a hybrid model that can be implemented either in person or virtually:

1. Physiotherapist supported multi-component exercise program
2. Nutrition and protein optimization including dietary counseling
3. Medication review with prescribing recommendations


Eligibility Criteria:
Inclusion Criteria:

* Pre-frail (score of 1 or 2) or frail (score of 3-5)
* ≥ 60 years old
* Receiving elective unilateral total hip or knee replacement
* Waiting time for surgery is estimated to be between 4 to 15 months

Exclusion Criteria:

* Renal disorder
* A neuromuscular disorder
* Active cancer
* Inflammatory arthritis
* Unable to speak or understand English and has no caregiver for translation
* Participating in another trial that involves protein supplementation
* Participating in an exercise program
Lanreotide and Octreotide Long Acting Release (LAR) for Patients With Advanced Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

An observational time and motion study in a clinical oncology setting is utilized in order to measure and compare product attributes and overall product efficiency between lanreotide and octreotide LAR.


Eligibility Criteria:
Inclusion Criteria:

* Men and women must be 18 years of age or older
* A current diagnosis of advanced, unresectable GEP-NET
* Provided written informed consent to participate in the study
* Currently receiving lanreotide or octreotide LAR and has received at least one prior injection of current somatostatin analogues (SSA).

Exclusion Criteria:

* Receiving treatment with lanreotide or octreotide LAR as part of a clinical trial
* Scheduled to receive a dose of lanreotide or octreotide LAR that would necessitate more than 1 injection on the same day
* Scheduled to receive any other treatment in the infusion center/room on the same day and as part of the same appointment
* Known hypersensitivity to somatostatin analogues
Effects of Emotional Stimulation on the Stress Levels of Healthy Persons

The purpose of this study is to evaluate the effects of a short-term emotional stimulation on the mood of healthy persons.

The trial assesses the effects of a emotion-centered stimulation on the mood of healthy persons. The outcomes will be evaluated with standard questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 45
* Ability to speak German

Exclusion Criteria:

* Physical or psychiatric disorders
* Consume of drugs or alcohol 24 previous to the test