cyrilzakka/clinical-trials huggingface dataset:
Use of the Amniotic Membrane in Large Wound Epithelialization

The purpose of this study is to analyze the security application of the amniotic membrane in extensive wounds in the granulation phase.


Eligibility Criteria:
Inclusion Criteria:

* Acute wounds in granulation phase with a minimum area of 100 cm2.
* Patients 18 or more years.
* Patients offering sufficient guarantees of adherence to protocol.
* Sign the written informed consent.
* Meet all inclusion criteria.

Exclusion Criteria:

* Patients with symptomatic chronic arterial insufficiency.
* Patients who are pregnant
* Patients in active lactation
* Patients physically fertile, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation precludes intercourse with a man and women whose partners have been sterilized by vasectomy or other methods, UNLESS they are using reliable contraception. This method of contraception can be:

  * Complete abstinence from sexual intercourse
  * Surgical sterilization (tubal ligation)
  * Surgical sterilization of the partner (vasectomy)
  * Implanted or injectable hormonal contraceptives, oral \*
  * Because hormonal contraceptives have a risk of thrombosis, should consider other methods of birth control.

These reliable contraception must be maintained during their participation in the study.

* Patients with heart, kidney, liver, systemic immune may influence the survival of the patient during the test.
* Participation in other clinical trials.
* Inability to understand informed consent.
The Effect of Pressure Ulcer Care Package on the Risk of Pressure Ulcer Development

This study aimed to determine the effect of pressure ulcer care package use on the risk of pressure ulcer development due to surgery in patients undergoing orthopedic surgery. It was planned as a randomized controlled study. The population of the study will consist of patients who underwent surgery in the Orthopaedics and Traumatology Clinic of Doğubayazıt Dr.Yaşar Eryılmaz State Hospital Hospital Hospital of Ağrı Provincial Health Directorate. The sample of the study will consist of patients who volunteered to participate in the study that meets the inclusion criteria. To obtain research data, the Personal Information Form developed by the researcher in line with the literature, 3S Operating Theatre Pressure Wound Risk Assessment Scale, Pressure Wound Regions and Stages Monitoring Form prepared according to NPUAP (2016) Pressure Wound Staging System Form will be used. Statistical analysis of the data obtained from the study will be performed using the SPSS 25 (Statistical Package of Social Science) package program.


Eligibility Criteria:
Inclusion Criteria:

* Orthopaedics and traumatology department
* Those who have undergone general or spinal anesthesia
* Without any communication problems
* Patients who volunteered to participate in the study

Exclusion Criteria:

* Patients with pre-operative pressure ulcer
* Those who are bedridden
* Patients referred to the intensive care unit after surgery
* Patients who wish to leave the study will be excluded from the study.
The Safety Study of Autologous TILs Therapy for Patients With Glioblastoma Multiforme.

The study is to evaluate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy for patients with maligant glioblastoma multiforme. Autologous TiLs should be given by intravenous infusion after 5 days of lymphodepletion treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 to 80 years old;
2. Has at least one measurable tumor foci;
3. ECOG score range : 0-2;
4. Expected survival time: ≥ 3 months;
5. All screening labs should be performed 7 days prior to registration.The laboratory results need to meet below criteria:

   * Absolute white blood cell counts (WBC) ≥ 3.0×10\^9/L；
   * Platelet count (PLT) ≥ 100×10\^9/L；
   * Hematological Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L；
   * Hemoglobin (HGB) ≥ 90g/L;
   * Albumin (absolute) ≥ 2.8g/dL;
   * Serum ALT/AST ≤ 2.5×ULN (for patients with liver metastasis ≤ 5×ULN);
   * Total bilirubin (TBIL) ≤ 1.5×ULN (for patients with liver metastasis ≤ 2×ULN);
   * Renal Serum creatinine OR measured or calculated a creatinine clearance (CR) ≤1.5×ULN OR≥ 50 mL/min for participant;
   * AST/ALT (SGOT) ≤ 2.5×ULN (for patients with liver metastasis ≤ 5×ULN);
   * International Normalized Ratio (INR) ≤ 1.5;
   * Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN;
6. Female participant of childbearing potential should have a negative result of human chorionic gonadotropin (HCG) test. The participants must take contraception during the entire clinical follow-up.
7. Be willing and able to provide written informed consent/assent for the trial.

Exclusion Criteria:

1. Has systemic active infection and requiring treatment;
2. Has severe physical or mental illness;
3. Has active rheumatic disease;
4. Has any kinds of organ transplantation;
5. Being pregnant or lactating;
6. Enrolled in other clinical trials within 4 weeks prior to registration;
7. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C;
8. Other conditions that the researcher considered to be excluded;
9. Has taken blow treatment before enrollment:

   * Received systemic immunosuppressive treatments, aside from corticosteroids within 14 days of treatment;
   * Plan to get inactivated vaccine 28 days prior/during, or 60 days post the treatment.
Postoperatory Recovery in Advanced Ovarian Cancer, Fast-Track Protocol vs. Classical Management

The concept of Fast-trak or Enhanced Recovery After Surgery ( ERAS) represents a new approach to the management of patients undergoing major surgery that re-examine traditional practices, replacing them if necessary with the best evidence based practices, creating a multimodal perioperative care pathway designed to achieve early recovery. In Colorectal Cancer Surgery , as well as in a number of other procedures it has been shown to reduce Hospitalization by more than 30% without increasing the rate complications or readmissions.

However information on the results of Fast-track protocols when applied to Gynecological patients is sparse, being especially notorious the lack of data regarding the efficacy of Fast-track in the management of Advanced Gynecological cancer.

Hypothesis: the application of a Fast-Track protocol in the management of patients with advanced Ovarian Cancer( Stage III, IV and relapses) may improve the postoperatory recovery of these patients allowing for an early discharge and significant cost reduction, when compared with de usual management, without increasing the number readmission or surgery related complications.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or more
* Advanced ovarian cancer ( FIGO Stages III-IV, and relapses) tributary to laparotomic surgical management.
* Patient accepts participation in the study and signs informed consent.

Exclusion Criteria:

* ASA IV
* Active ischemic cardiac condition
* Advanced cirrhosis ( Child-Pugh B -C).
* Severe Psychiatric condition ( patient not capable of giving her informed consent properly, not capable or not willing to attend Follow-up visits).
Remote Participation (Within USA) Trial of Sana Pain Reliever

Randomized controlled trial to assess the effectiveness and patient perception of the benefit of the Sana Pain Reliever in individuals with chronic neuropathic pain.The study is fully remote with four study visits taking place over teleconferencing and the study devices mailed to the participants to use at home for 8-14 weeks.

Chronic neuropathic pain (NP) is an extremely debilitating condition with few treatment options and many of which with multiple side effects. This will be a randomized, sham-controlled trial that will investigate the effectiveness of a novel wearable device called the Sana Pain Reliever (Sana PR) at reducing chronic neuropathic pain. The Sana PR is a device comprised of a Mask to be worn over the eyes with a pair of ear buds to be worn in ears. It displays light and sounds in a predetermined algorithm which runs for 16 minutes at a time. The underlying mechanism of action for the Sana PR is Audio Visual Stimulation (AVS), a form of non-pharmacological intervention that induces a brain wave response called Frequency Following Response (FFR), which has been used for both performance enhancement and symptom management. The device will be used with a compatible tablet application that will collect data from each session that the device is used. This data will be collected through user inputs of responses to several questionnaires. This will be an at-home trial and participants will be loaned the Sana Pain Reliever device and a tablet device to run the application for the duration of the study. The trial will last a total of 14 weeks and will involve four study visits, either in-person at the Abilities Research Center at Mount Sinai Hospital in New York City, or remotely using a video call. The trial includes two baseline sessions on weeks 0 and 2, 8 weeks of the at-home intervention, and post-intervention sessions at the end of weeks 10 and 14. Participants will be instructed to use the device at the end of the day prior to going to sleep as well as whenever they experience greater than typical pain during the day . Data during the at home portion of the trial will be recorded daily via the application. The application will also prompt participants to answer fortnightly weekly questionnaires and send out compliance reminders. Additionally, a series of pain, sleep and quality of life assessments will be completed by participants at both baseline visits, a post-intervention visit and a 4-week follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed clinical diagnosis of neuropathic pain
* Age of 18 years or older at time of consent
* Fluent in English
* Consistent medications for the last 4 weeks prior to the first baseline visit (week 0)

Exclusion Criteria:

* Diagnosis of photosensitive epilepsy
* Active ear or eye infection
* Vision impairments that affect perception of light in one or both eyes
* Deafness in one or both ears
* Severe depression (Score higher than 30 points on the Beck's Depression Inventory)
Evaluating the Cologuard Test for Use in Lynch Syndrome

This study is aiming to enroll 90 patients with genetically confirmed Lynch Syndrome (LS) from Geisinger's High Risk Colorectal Cancer Clinic (HRC). Upon enrollment in the study, a Cologuard test will be ordered and the results will be blinded until data analysis. Patients enrolled in the study will also undergo a colonoscopy as part of their routine HRC visit.

The primary aim is to perform a pilot study to gain information toward the implementation of a larger prospective study that will compare the performance of Cologuard with the gold-standard colonoscopy in identifying advanced adenomas and colorectal cancers in LS. Data regarding rate of consent, and adherence to the protocol will be recorded. Since patients with known genetic predisposition to cancers tend to view screening tests more positively than the general population, a second aim of the study is to evaluate patient satisfaction with bowel preparation, colonoscopies, and Cologuard testing. Up to 90 individuals with genetically confirmed LS will be recruited via Geisinger's HRC to complete a goal of 90 Cologuard studies. Upon enrollment, Cologuard will be ordered by the study team at no cost to the subject and will be completed according to the standard instructions for use. Results will be securely obtained and blinded until the time of data analysis. Subjects will undergo colonoscopy as part of their routine HRC visit. Results from the colonoscopy (and biopsy as indicated) will be retrieved from the Electronic Health Record (EHR) and documented in a research-associated spreadsheet. If repeat colonoscopy is clinically indicated, repeat Cologuard may be completed if the subject meets inclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18-89
* Diagnosis of genetically confirmed LS
* Scheduled for standard of care colonoscopy within 60 days of enrollment

Exclusion Criteria:

* Diagnosis of other inherited genetic disorders that increase risk for Colorectal Cancer (CRC) (Familial Adenomatous Polyposis (FAP), Cowden's syndrome, Turcot syndrome, Gardner syndrome, and Peutz-Jeghers syndrome)
* Diagnosis of other inherited Inflammatory bowel disease (i.e. Crohn disease, ulcerative colitis)
* Others with elevated risk of CRC outside of the inclusion criteria (i.e. ≥2 first-degree relatives who have been diagnosed with CRC without a defined inherited genetic disorder, Hereditary Non-Polyposis Colon Cancer (HNPCC) without genetic confirmation of LS)
* Participation in any interventional clinical study within the previous 30 days
* Personal history of CRC not in full remission (5 consecutive cancer-free years)
* Current active treatment with chemotherapy
* Treatment with chemotherapy within 12 months prior to consent date
Safety and Tolerability Study of Macitentan in Patients With Idiopathic Pulmonary Fibrosis

The MUSIC OL study is an open-label extension study, in which all eligible patients having completed the double-blind AC-055B201/MUSIC study as scheduled receive macitentan 10 mg once daily. The study objective is to assess the long-term safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis (IPF).


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to initiation of any study-related procedure.
* Patients with IPF and having completed the double-blind AC-055B201/MUSIC study as scheduled, i.e., having remained in the study until the sponsor-declared end-of-study (EOS), whether or not study treatment was prematurely discontinued.
* Women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception during study treatment and for at least 28 days after study treatment termination.

Exclusion Criteria:

* Any major violation of protocol AC-055B201/MUSIC.
* Premature discontinuation of study treatment during the AC-055B201/MUSIC study due to an adverse event (AE) assessed as related to the use of macitentan, excluding events of IPF worsening.
* Pregnancy or breast-feeding.
* AST and/or ALT \> 3 times the upper limit of the normal range.
* Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
* Known hypersensitivity to drugs of the same class as macitentan, or any of the excipients.
Effects of Episodic Food Insecurity in African American Women With Obesity

The objective of this exploratory/developmental study is to investigate the episodic nature of food insecurity as a stressor via responses in body weight and psychological and physiological parameters longitudinally. Sixty African American women with obesity will be enrolled. Pennington Biomedical Research Center will coordinate this longitudinal study and measure 1) daily body weight remotely over 22 weeks and 2) psychological and physiological parameters via clinic assessments at the beginning and end of 22 weeks as well as assess episodes of food insecurity and stress on a weekly basis.


Eligibility Criteria:
Inclusion Criteria:

* willing to provide written informed consent
* female
* self-reported race of African American or more than one race in which African American is identified
* 18 to 65 years of age
* BMI 30 to 50 kg/m2
* reported income ≤ 250% of the federal poverty level
* ability to complete questionnaires in English
* willing to archive blood and urine samples
* willing to fast for a minimum of 8-10 hours prior to clinic visits

Exclusion Criteria:

* male
* self-reported race other than African American or more than one race in which African America is not identified
* reported income \> 250% of the federal poverty level
* given birth within the past 6 months, currently pregnant, or plans to become pregnant within 6 months
* currently breastfeeding
* currently participating in a weight loss program
* current use of prescription or OTC medication specifically for weight loss
* recent weight loss (+/-5% weight change in last 6 months by self-report). If ppt is on a prescription medication that impacts weight but meets weight stability criteria (+/-5% weight change in last 6 months by self-report), ppt will be deemed eligible
* past bariatric surgery within the past 5 years or plans for bariatric surgery within 3 months
* active cancer or cancer treatment
* serious digestive disorders that significantly alter metabolism and weight (like uncontrolled inflammatory bowel disease)
* other conditions that affect metabolism or body weight
* current diagnosis and active treatment for alcoholism or other illicit drugs of abuse
* uncontrolled significant thyroid disorder (controlled = 6 months of medication)
* uncontrolled significant diabetes (FBS \>250) or hypertension (BP \>180/100)
* current diagnosis or treatment for heart failure
* serious psychiatric illness, including bipolar disorder and schizophrenia
* current or recent diagnosis (within last 5 years) of an eating disorder
* persons who weigh more than 380 pounds (due to scale)
* not willing to be able to re-contacted
* are unable to utilize devices and/or applications as required for study participation
* have another member of the household (same address) that is a participant in RESPONSES
* other conditions that affect metabolism or body weight as determined by the PIs and MI
* presence of any cognitive, psychiatric, behavioral, or medical disorder that, in the opinion of the PIs or MI may interfere with study participation
Canadian Real-World Outcomes of Omnipod Initiation in People With T1D

The current study aims to assess clinical outcomes in adults with type 1 diabetes (T1D) who have switched from traditional multiple daily injection (MDI) therapy to continuous subcutaneous insulin infusion (CSII) therapy with the Omnipod insulin system.

Poor glycemic control is associated with increased risk of diabetes-related complications in persons with type 1 diabetes (T1D). Despite advancements in insulin therapies and an increase in diabetes technology use, only 21% of adults with T1D are meeting their targeted glycated hemoglobin (A1C) levels. The Omnipod insulin system is a patch pump that consists of a handheld controller and disposable pod that delivers insulin. A retrospective analysis of medical records in the United States found that there was a significant reduction in A1C three months after initiating Omnipod in pediatric, adolescent and adult populations with T1D who switched from either MDI or traditional CSII. Currently, the real-world effectiveness of the Omnipod compared to MDI in adults with T1D on glycemic control, weight, and insulin dose, is not established.

The Canadian Real-World Outcomes of Omnipod Initiation in People with T1D: Evidence from the LMC Diabetes Registry (COPPER) study is a retrospective, observational study using demographic and clinical data from the LMC Diabetes Registry, which consists of over 42,000 active patients with diabetes across 3 Canadian provinces. The overall objectives of this study are to assess clinical outcomes in adults with T1D who switch from MDI to CSII therapy with Omnipod, and to compare clinical outcomes in the Omnipod cohort to a matched cohort of MDI users.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of T1D ≥ 12 months prior to initiating the Omnipod
* Age ≥ 18 years
* Switched from MDI to Omnipod (Omnipod cohort)
* Persistent with OmniPod treatment for ≥ six months
* No change in basal insulin type or bolus insulin type between baseline and follow up (matched MDI cohort)
* ≥ one A1C measurement during the baseline and follow-up period

Exclusion Criteria:

* Switched from traditional CSII to OmniPod
* Use of non-insulin diabetes therapies
Investigating the Impact of Proactive Palliative Care

This study will test whether adding personalized supportive care to medical treatment on a clinical trial affects the study participants' ability and desire to discuss their symptoms, their concerns about the future, and their approach to coping with cancer. The effects of supportive care on participants' responses to questions about these topics will be compared with those of other study participants who are being treated for cancer in a clinical trial, but are not receiving personalized supportive care.


Eligibility Criteria:
Inclusion Criteria:

* Patients with disease progression on at least one standard chemotherapy regimen, and now eligible and consented to begin Phase I, Phase I/Ib, Phase I/II and non-randomized Phase II (including basket studies) investigational targeted and immune-based therapeutics in MSK medical oncology, EDD, or ITC clinics
* Able to speak, read, and understand English well enough to complete study assessments in the judgment of the consenting professional
* 18 years of age and older
* Has a progressive or metastatic solid tumor cancer with MSK pathology confirmation at the primary or metastatic anatomic site

Exclusion Criteria:

* Patients who already are receiving specialty supportive care (already referred for a supportive care consultation) prior to enrollment in a Phase I protocol.
* Patients will be excluded if the Phase I, Phase I/Ib, Phase I/II or Phase II trial involves known active drugs in combination with experimental drugs, in which the patient has not previously received the known active drug or active drugs of the same class. For example, a patient with metastatic pancreatic cancer who has not received gemcitabine/nab-paclitaxel, but enrolls on a study that tests an experimental drug in addition to gemcitabine/nab-paclitaxel, will be excluded.
* Significant psychiatric or cognitive disturbance in the primary clinician"s or investigator"s judgment, to preclude providing informed consent or participating in the interventions (i.e. acute psychiatric symptoms which require individual treatment)