cyrilzakka/clinical-trials huggingface dataset:
Web-based Visit for Colorectal Surgery

The purpose of this study to evaluate how well an online format would work for the first post-operative visit after a patient undergoes colon and rectal surgery. This online format is integrated into Epic MyChart. This study aims to determine whether the online format is feasible and acceptable to patients and surgeons as a standard post-operative visit.

Participants were asked to complete a post-operative survey using an online patient portal, EPIC MyChart, after elective abdominal colon or rectal resection. Participants were also asked to do upload a picture of their incisions. Colorectal surgeons reviewed responses/pictures and communicated concerns/recommendations via the same patient portal. At the in-person follow-up visit, both patients and colorectal surgeons completed a satisfaction survey regarding the both visit types.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. Planned/underwent surgery that was performed by a surgeon in the Division of Colon and Rectal Surgery
3. Requires a post-operative follow-up outpatient visit 2-3 weeks from surgery or from discharge from hospital
4. Has access to a smart mobile phone, tablet or computer to access online web interface for the web-based visit
5. Patients with an Epic MyChart account set up.
6. Has ability to take photographs of surgical incision or has access to someone who can take a picture for them.

Exclusion Criteria:

1. Requires visiting nurse services at discharge from hospital
2. Cannot use web-based interface or unable to complete questions online
3. Cannot read English, speak English, or would require interpreter services. The reason for excluding these patients is there are not yet MyChart services available in non-English languages at Umass Memorial. It would not be fiscally possible to acquire these for a pilot feasibility study. As the MyChart experience is meant to be completed at home, it would not be possible to provider a medical interpreter in a non-office or hospital setting.
4. Adults unable to consent (adults lacking capacity)
5. Individuals who are not yet adults (infants, children, teenagers)
6. Prisoners
7. Pregnant women
8. Patients undergoing anal surgery
Ph II Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA NSCLC

RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving carboplatin together with docetaxel after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving carboplatin together with docetaxel works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.

OBJECTIVES:

Primary

* Evaluate the feasibility of adjuvant carboplatin and docetaxel in patients with resected stage I, II, or IIIA non-small cell lung cancer.

Secondary

* Determine the toxicity of this regimen in these patients.
* Determine the survival patterns of patients treated with this regimen.
* Assess the patterns of recurrence in patients treated with this regimen.

OUTLINE: Patients receive carboplatin IV on day 1 and docetaxel IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Inclusion criteria:

* Histologically confirmed non-small cell lung cancer

  * Stage I-IIIA disease
* Must have undergone a complete resection
* Must begin adjuvant chemotherapy within 8 weeks of surgical resection

PATIENT CHARACTERISTICS:

* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Absolute neutrophil count ≥ 1,500/mm\^3
* Hemoglobin ≥ 8.0 g/dL
* Platelet count ≥ 100,000/mm\^3
* Serum creatinine normal OR creatinine clearance ≥ 40 mL/min
* Bilirubin normal
* Alkaline phosphatase (AP), Aspartate aminotransferase (AST), and Alanine transaminase (ALT) must meet 1 of the following criteria:

  * AP normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
  * AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN
  * AP ≤ 5 times ULN AND AST and ALT normal
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 3 months after study therapy

Exclusion criteria:

* Patients with a history of severe hypersensitivity to docetaxel or polysorbate 80 are excluded.
* Women who are currently or planning to breast feed.
* Those with peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

* 2-8 weeks since prior surgery and recovered
A Study of the C3 Inhibitor AMY-101 in Patients With ARDS Due to COVID-19 (SAVE)

The study is a prospective, randomized, placebo-controlled, single-blind phase 2 clinical study of the efficacy and safety of AMY-101, a potent C3 inhibitor, for the management of patients with ARDS caused by SARS-CoV-2 infection.

We will assess the efficacy and safety, as well as pharmacokinetics (PK), and pharmacodynamics (PD). The study will assess the impact of AMY-101 in patients with severe COVID19; specifically, it will assess the impact of AMY-101 1) on survival without ARDS and without oxygen requirement at day 21 and 2) on the clinical status of the patients at day 21.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Acute Respiratory Distress Syndrome due to SARS-CoV-2 infection (severe Covid-19), according to the following criteria:

  1. Demonstration of SARS-CoV-2 RNAemia in nasopharyngeal swap or bronchio-alveolar lavage (BAL)
  2. A ratio of the partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2), PaO2/FIO2, ≤300 mmHg

     * Mild ARDS (PaO2/FIO2, ≤300 and \>200 mm Hg);
     * Moderate ARDS (PaO2/FIO2, ≤200 and \>100 mm Hg);
     * Severe ARDS (PaO2/FIO2, ≤100 mm Hg);
  3. Pulmonary infiltrates suggestive of SARS-COV-2-related ARDS: e.g., bilateral infiltrates at chest X-ray or B-lines at lung US scan.
* Dated and signed informed consent from patient or legal represantative.

Exclusion Criteria:

* Intubated patients
* Demonstrated or suspected uncontrolled systemic severe infection, such as sepsis (e.g.: positive blood culture, or procalcitonin ≥0.25 µg/L)
* Demonstrated local extrapulmonary abscess
* ARDS due to cardiac failure or fluid overload
* Concomitant treatment with immunomodulatory /immunosuppressive drugs , which have potential activity against the disease
* Multi Organ Failure (MOF)
* Severe renal failure (CKD, by defition glomerular filtration rate \<30 ml/min)
* Neisseria meningitidis infection that is not resolved
* Current treatment with a complement inhibitor
* Intravenous immunoglobulin (IVIg) within 3 weeks prior to Screening
* Participation in another interventional treatment study within 30 days before initiation of the study treatment (Day 1 in this study) or within 5 half-lives of that investigational product, whichever is greater.
* Chemotherapy for less than 3months
* Pregnancy
* Age \<18.
Phase I Mitomycin Combined With Bacillus Calmette-Guérin (BCG) for Bladder Cancer

The study aims to establish the safety and toxicity of a combined intravesical mitomycin C with BCG for patients with bladder cancer.

Urine Sample Collection and Handling: Voided urine will be collected pre and post BCG procedure. Urinalysis will be performed if participant presents with urinary symptoms. Analysis of urinary cytokines as predictors of response to therapy will be conducted by ELISA kits.

Tissue Sample Collection and Handling: Tissue biopsy specimens will be collected pre BCG procedure. Analysis of gene expression will be conducted.

TEST PROCEDURES Subjects will be given one of three concentrations of Mitomycin C (MMC) (10 mg in 20 mL, 20 mg in 20 ml or 40 mg in 20 ml) for 30 minutes followed by a 10 minute washout period. Followed by three concentrations of BCG including ¼ strength, ½ strength, and full strength for 2 hours. Dose escalation will take place among subsequent patients and not within each patient.

Approximately 30 subjects will be enrolled to reach the target completion enrollment of 10 subjects.

Long-term Follow-up A Chart review will be conducted every three months for 2 years after initial 6 month study data collection. Patient charts will be reviewed to assess disease progression and any data supporting findings. Long-term follow-up is necessary to determine recurrence rates and long-term safety and efficacy of Mitomycin/BCG treatment therapy as well as BCG therapy in the control group.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed or recurrent multi-focal Ta, large Ta, high-grade Ta, CIS, or T1 bladder cancer
2. In urologist's opinion a good candidate for BCG induction therapy
3. Be able to give informed consent
4. Be age 18 or older.

Exclusion Criteria:

1. Inadequate marrow function (defined as granulocytes less than 1,500 cells/mm3 and platelets less than 150,000 cells/mm3)
2. Immunosuppressed state (e.g. HIV, use of chronic steroids)
Motivational Interviewing for Weight Loss

The investigators studied the effect of motivational interviewing (MI) on self-efficacy, health behaviors, and health outcomes in overweight children and adolescents (ages ranging from 10 to 18 years).

One empirically supported intervention with a large evidence base for improving adult outcomes in behavioral health-related disorders is Motivational Interviewing (MI). MI is strongly rooted in the client-centered therapy of Rogers (1951). Its relational stance emphasizes the importance of understanding the client's internal frame of reference and displaying unconditional positive regard for the client. Motivational interviewing can thus be defined as a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence. MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.

Adolescent participants exposed to motivational interviewing in conjunction with usual care (diet and exercise program) are expected to endorse greater self-efficacy, report increased engagement in healthy behaviors, demonstrate a decrease in body weight and report improved psychological outcomes. While motivational interviewing has been shown to increase adults' motivation to make healthy behavior changes, few adolescent studies have demonstrated this effect.

Eligibility Criteria:
Inclusion Criteria:

* Obese youth (with Body Mass Index (BMI) ≥ to 85th percentile for age and gender (as classified by the Center for Disease Control))
* ages 10-18 years
* attending a local obesity clinic ("Healthy Weights" clinic)

Time of entry into the weight-loss program was controlled for; however, both new and current participants had the option to participate in the study.

Exclusion Criteria:

* taking medication whose side effects may influence weight gain or weight loss
* did not speak English
* demonstrated a developmental delay
* reported being pregnant and/or reported having an eating disorder
Seizure Rescue Medication: Caregiver Education in a Simulation Setting

1. Design an educational quality improvement program to assess the most effective educational approach on caregiver seizure RM application. The investigators hypothesize that this educational program will improve caregiver comfort, knowledge of emergent seizure care, and time to medication application.

Specifically, the aims include:

1. Create an educational video reviewing RM administration
2. Develop and validate a simulation training model/mannequin for rectal diazepam administration
3. Expand training to other seizure RMs (e.g. intranasal midazolam, buccal lorazepam) and transition the most effective educational model back to the clinics/bedside to standardize caregiver teaching throughout the department/hospital

The investigators will implement an intervention jointly with a simulation program to determine the most effective training model: verbal instructions, instructional video, or use of a mannequin. Caregivers will undergo a training curriculum, and 60 caregivers (20 assigned to each educational model) will be matched into three groups and assigned to participate in one of three educational models in the SIM Center. Pre-and post-training questionnaires will be distributed to assess provider knowledge and comfort level. Scoring of caregiver technique administering rectal diazepam to a mannequin and time to RM administration will be obtained to compare between the three educational arms of the study. Thirty additional patients (10 per group) will not receive an assessment of caregiver technique administering RM to the mannequin prior to the educational intervention to control for exposure to the mannequin. Ultimately, the most effective educational method in this simulation pilot study will be expanded to other RM types (e.g. intranasal midazolam, buccal lorazepam), standardized, and brought back to the clinics/bedside throughout the hospital.

Eligibility Criteria:
Inclusion Criteria:

1. Adult caregivers of patients with epilepsy followed at BCH with the following:

   1. At least one seizure \>5 minutes
   2. Prescription for rectal diazepam rescue medication
   3. Admission for seizure/neurologic problem or neurology/epilepsy clinic visit during the enrollment period
2. Adult caregivers of patients without epilepsy

Exclusion Criteria:

1. Adult caregivers of epilepsy patients without a rectal diazepam prescription
2. Non-English-speaking caregivers
DuraSorb® in Prosthetic Breast Reconstruction

This study compares outcomes of prospective mesh-based breast reconstructions to historical control breast reconstructions with no mesh.

Plastic surgeons have a variety of biologic and synthetic mesh available for use. However, no mesh has adequately evaluated safety and effectiveness for FDA approval or clearance for use in breast reconstruction. Therefore, no mesh is an appropriate comparator for a randomized clinical study.

This multi-center, prospective, clinical study with matched historical controls of total submuscular 2-stage breast reconstructions with no mesh will evaluate the safety and effectiveness of DuraSorb® monofilament surgical mesh when implanted in subjects undergoing 2-stage breast reconstruction.

Women scheduled for mastectomy and immediate 2-stage breast reconstruction will sign informed consent and satisfy eligibility criteria prior to the first stage of surgery and DuraSorb® implantation.

Maximum study follow-up is through one year after definitive reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* Female between the inclusive ages of 22 and 70 at the time of initial expander surgery
* Scheduled to undergo either unilateral or bilateral mastectomy with immediate 2-stage breast reconstruction
* Is able to understand the study requirements and is willing to provide written informed consent
* Is willing and able to return for all scheduled study visits

Exclusion Criteria:

* Is pregnant or planning to become pregnant during study participation
* Has a history of failed tissue expansion or breast implantation at the intended reconstruction site
* has a residual gross tumor at the intended reconstruction site
* has been treated for a systemic infection or a local infection at the surgical site that the investigator determines will affect the safety of the subject during breast reconstruction and/or mesh use
* has, as determined by the investigator, unsuitable tissue integrity for immediate 2-stage breast reconstruction
* has undergone previous radiation therapy to the reconstruction site or chest wall
* is scheduled to undergo post-operative radiation therapy at the reconstruction site
* has a Body Mass Index (BMI) \< 14 or \> 44
* has used nicotine products within 90 days of screening
* is currently taking medications including non-NSAID anti-coagulants, immunosuppressants (including systemic steroids), or other medications determined by the investigator to place the subject at an increased risk of local complications of breast reconstruction
* has been diagnosed with a comorbid condition determined by the investigator to place the subject at an increased risk of complications
* has participated in any other clinical study that the investigator feels may interfere with this clinical study
Par-4 and Telomere-telomerase System in Type 2 Diabetes Patients Who Received GLP-1 or Metformin Treatment

Objectives: To investigate the treatment effect between insulin,metformin and Liraglutide; in Type 2 Diabetes in our hospital, in order to investigate the possible mechanism about telomere-telomerase system and Par-4.

160 Type 2 diabetes in our hospital will divide into 4 groups: group A (40 healthy volunteers), group B (40 patients who give basal and insulin treatment, group C（40 patients who give basal and Liraglutide treatment),group D（40 patients who give basal and metformin treatment). The age, height, weight, blood glucose, glycosylated hemoglobin A1c（HbA1c）,homeostasis model assessment(HOMA-IR), lipid, blood pressure, course of disease, telomere length,telomerase activity will record respectively. And High-sensitive C-reactive protein (HsCRP), Par-4, GST,SOD,GSH-PX,ATF-6,CHOP,XBP-1 and Tumor necrosis factor-α（TNF-α） will detect as Baseline. After each group's treatment, Change from baseline of all indexes will record, Multifactor logistic regression will be analyzed the correlations between each positive indexes.

Eligibility Criteria:
Inclusion Criteria:

* Newly dignosised type 2 diabetes according to WHO criteria.glycated hemoglobin (HbA1c) was more than 10%;
* Seronegative for antibodies against insulin, islet cells and glutamic acid decarboxylase (GAD);

Exclusion Criteria:

* Type 1 diabetes mellitus,presence of autoimmune diabetes indicated by antibodies to insulin, islet cells, and GAD；
* Gestational diabetes;
* patients with heart, liver, or renal function impairment;presence of severe infections or cerebrovascular disease;
Exercise for Advanced Prostate Cancer: a Multicomponent Feasibility Trial

This feasibility study will investigate whether men with metastatic prostate cancer can take part in and progress through a home-based exercise program. This study will evaluate the effects of exercise on a range of disease and treatment-related outcomes.

This 12 week multicomponent, tailored, progressive program will consist of both moderate intensity walking and strengthening exercises at home. This single centre, single arm study will incorporate a behavioural change consultation at baseline and weekly behavioural support throughout. This study will follow-up patients at 24 weeks to determine exercise maintenance. Outcome measures will be completed at baseline, 12 and 24 weeks. A qualitative evaluation will be conducted after the 24 week follow-up to determine impact, patient experience and measures that might assist in refining the program.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented adenocarcinoma of the prostate with progressive systemic metastatic disease despite castrate levels of testosterone (\<50ng/dL).
* At enrolment, patients must have demonstrated progressive disease since the most recent change in therapy.
* Patients must be on ADT with a GnRH agonist/antagonist or prior bilateral orchiectomy. All patients must be on ADT during the study period.
* ≥ 4 weeks since last surgery and fully recovered.
* No known contraindications to moderate intensity exercise such as (but not limited to) brain metastases, acute congestive heart failure, unstable angina, serious or non-healing wound, peripheral neuropathy greater than or equal to Grade 3. Recent myocardial infarction.
* Age ≥ 18 years.
* ECOG performance status 0-2.
* Medical clearance by treating clinician.

Exclusion Criteria:

* Men currently exceeding ACSM recommended exercise guidelines (150 mins of moderate and/or 60 mins of high intensity exercise per week).
* Men with brain metastases.
* Men with a currently active second malignancy other than non-melanoma skin cancer.
* Congestive heart failure or recent serious cardiovascular event.
* Chest pain brought on by physical activity.
Ursodeoxycholic Acid in C. Difficile Infection

The primary objective of the study is to assess tolerability and adherence to treatment with ursodeoxycholic acid


Eligibility Criteria:
Inclusion Criteria:

* Completion of a course of antibiotic treatment for C. difficile infection within the previous 7 days

Exclusion Criteria:

* • Pregnant or Breast-feeding

  * Gall bladder inflammation
  * Frequent episodes of biliary colic
  * Occlusion of the common bile duct or cystic duct
  * Active small intestinal inflammation
  * Previous resection of distal small intestine
  * Treatment with bile salt binding agents, ciclosporin or ciprofloxacin
  * Diarrhoea (from any cause) at study initiation
  * hypersensitivity to bile acids or any excipient of the formulation
  * Life expectancy less than 6 months
Ultrasound-guided Serratus Plane Block for the Quality of Recovery After Modified Radical Mastectomy

Regional anesthesia improves quality of recovery after surgery in many studies. Ultrasound-guided serratus plane block is a novel technique which may be a viable alternative to current regional anesthetic techniques. This randomized, controlled trial is to examine the effects of ultrasound-guided serratus plane block anesthetic on the QoR after breast tumor resection.

A total of 72 subjects (36 patients for each groups) were enrolled in this study. Patients were allocated to either the general anesthesia group (group control) or SPB (serratus plane block) + general anesthesia groups (group SPB) using randomized central computer-generated sequence software (SAS 19.0). The allocation ratio was 1:1 for the two groups. Group assignment was concealed by opaque sticking envelops. The major research content is to evaluate the quality of recovery using 40 questionnaire (QoR-40).

Eligibility Criteria:
Inclusion Criteria:

* Patients of American Society of Anesthesiologists' (ASA) Physical Status class I-II scheduled for first modified radical mastectomy were included.

Exclusion Criteria:

* Patients with chronic ethanol
* long-term use of psychotropic drugs (e.g. sedative drugs and antidepressant);
* contraindications for serratus plane block including coagulopathy, infection at the puncture site;
* unable to cooperate with this research due to cognitive impairment, psychopathy or not willing for the hospital follow-up;
* administration of other test drugs or joining in other clinical study in 3 months before our study;
* received radiotherapy or chemotherapy before surgery;
* other conditions not allocated for this study out of the researchers' consideration.