cyrilzakka/clinical-trials huggingface dataset:
Treatment Response Prediction System of mCRC Patients Based on CTC

This study enrolling patients with metastatic colorectal cancer. Detecting CTC at different points in the treatment process. Descripting the molecular atlas of CTC in mCRC patients. Building and validating a response prediction system of mCTC patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years;

histologically proven colorectal liver metastasis

With liver-dominant disease (extrahepatic metastases limited to lung metastases)

ECOG 0-1

A life expectancy of ≥ 3 months

Adequate hematologic function: absolute neutrophil count (ANC)≥1.5×109/l, platelets≥75×109/l, and international normalized ratio (INR) ≤1.3

Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, alanine aminotransferase, aspartate aminotransferase ≤ 5x upper limit of normal, and albumin≥2.5 g/dl, serum creatinine≤2.0 mg/dl

Written informed consent for participation in the trial.

Exclusion Criteria:

* Other previous malignancy within 5 years

Have metastases other than liver and lung metastases

Receiving any treatment before first blood collection
A Study of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 in Participants With Locally Advanced, Unresectable Pancreatic Cancer

This is a Phase 1/2 trial to evaluate the safety, tolerability, and efficacy of FG-3019 administered with gemcitabine and nab-paclitaxel in the treatment of locally advanced, unresectable pancreatic cancer.


Eligibility Criteria:
Key Inclusion Criteria:

* Male, or non-pregnant and, non-lactating female
* Histologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC)
* Radiographic and pathologic staging consistent with pancreatic cancer, locally advanced, unresectable (per National Comprehensive Cancer Network® \[NCCN®\] criteria)
* Laparoscopic confirmation that PDAC is locally advanced. Biliary stents are permitted.
* Measurable disease as defined by RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate liver, bone marrow, and renal function
* Agree to use contraception per protocol
* Less than Grade 2 pre-existing peripheral neuropathy

Key Exclusion Criteria:

* Prior chemotherapy or radiation for pancreatic cancer
* Solid tumor contact with superior mesenteric artery (SMA) \>180°
* Previous (within the past 5 years) or concurrent malignancy diagnosis (expect non-melanoma skin cancer and in situ carcinomas)
* Major surgery, within 4 weeks prior to Day 1 on study
* History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies
* Exposure to another investigational drug within 42 days of first dosing visit, or 5 half-lives of the study product (whichever is longer)
* Uncontrolled intercurrent illness
* Any medical condition that, in the opinion of the Investigator, may pose a safety risk to a participant in this trial, may confound the assessment of safety and efficacy, or may interfere with study participation.
* Current abuse of alcohol or drugs
A Study of LY3502970 in Chinese Participants With Obesity or Are Overweight With Weight-related Comorbidities

The main purpose of this study is to learn about the safety and tolerability of LY3502970 when given to Chinese participants with obesity or overweight with weight-related comorbidities. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive LY3502970, or placebo given orally. For each participant, the study will last about approximately 22- and 30-weeks for both cohort 1 and 2, respectively including screening period.


Eligibility Criteria:
Inclusion Criteria:

* Are native Chinese males or females
* Have had a stable body weight for the 3 months prior to randomization (less than 5% body weight change) and body mass index of ≥ 30.0 kilograms per square meter (kg/m²) or between 27.0 up to 30.0 kg/m² with at least 1 of the following weight-related comorbidities including Hypertension, Dyslipidemia, Cardiovascular disease, Obstructive sleep apnea

Exclusion Criteria:

* Have any prior diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), or rare forms of diabetes mellitus
* Have used or intend to use any prescription or over-the-counter medications or traditional Chinese treatments within 3 months prior to screening, exception of medications for the treatment of concurrent medical conditions with a stable dose
* Have known allergies to GLP-1RAs, LY3502970, related compounds, any components of the formulation, or have a history of significant atopy
* Are overweight or have obesity induced by other endocrinological disorders, diagnosed monogenetic, or syndromic forms of obesity
* Have or plan to have a surgical, endoscopic or device-based treatment for obesity
* Have a history or presence of psychiatric disorder, a moderately severe or severe depression status, or a significantly risk for suicide
* Have a history of acute or chronic pancreatitis
* Have a known self or family history of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma
* Have other acute, chronic, or uncontrolled medical conditions, vital organ failure or abnormal laboratory value in the judgment of the investigator would make the participant inappropriate for entry into this study
Effect of Intraoperative Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Major Abdominal Surgery

To observe the effect of intraoperative dexmedetomidine on the incidence of postoperative delirium, postoperative analgesic drug requirements and pain scores in elderly patients undergoing major abdominal surgery.

This study is a multicenter, randomized, double-blind, placebo-controlled trial. Three hundred patients undergoing elective major abdominal surgery were randomized to the intervention and control groups. Patients in the intervention group were given a loading dose of 0.6 μg/kg of dexmedetomidine by intravenous infusion within 10 minutes after intubation, followed by a continuous infusion at a rate of 0.4 μg/kg/h until 30 min before the end of the procedure; patients in the control group were given an equal volume of saline. Data were collected at 1-5 days and 1 month postoperative follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 65 years old
* Patients undergoing elective major abdominal surgery
* Written informed consent was obtained

Exclusion Criteria:

* Patients with severe preoperative cognitive impairment (MMSE ≤ 20) who are unable to undergo a follow-up evaluation.
* Patients with history of psychiatric or neurological disorders.
* Patients with body mass index ≤ 18 or ≥ 30
* Patients with severe bradycardia (heart rate less than 40 beats per minute)
* Patients with pathological sinus node syndrome or grade 2 or greater AV block
* Patients with severe hepatic or renal insufficiency.
* Patients with severe hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg)
Clinical and Electrographic Changes in Responsive Neurostimulation System (RNS) Patients with Acupuncture Treatment

The purpose of this study is to determine effects of Acupuncture on a Patient's mood and cognition,evaluate changes in clinically-reported seizure frequency and severity and analyze effects of Acupuncture on electrographic epileptiform activity stored by the RNS System


Eligibility Criteria:
Inclusion Criteria:

* Patient implanted with the RNS system
* Patient can undergo 12 weeks of acupuncture
* Patient is able remain on stable medications for 12 weeks
* Patient is able to remain on stable Detection and Stimulation settings for 12 weeks
* Patient or/and caregiver is able to understand and sign informed consent and HIPAA authorization
* Patient or caregiver able to maintain a seizure diary for duration of study

Exclusion Criteria:

* Patient and /or caregiver is unable to sign informed consent to study
* Patient has a bleeding disorder, pacemaker, or pregnant
Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma

This is a Phase 1 dose escalation study following a 3+3 study design. The purpose of the TRAVERSE study is to assess the safety, efficacy, and cell kinetics of ALLO-316 in adults with advanced or metastatic clear cell renal cell carcinoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647 to define a Phase 2 dose.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed renal cell carcinoma with a predominant clear cell component.
* Must have received a checkpoint inhibitor and a VEGF inhibitor in the advanced and/or metastatic setting.
* At least one measurable lesion as defined by RECIST version 1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
* Absence of donor (product)-specific anti-HLA antibodies (DSA).
* Adequate hematological, renal, liver, pulmonary, and cardiac functions.

Exclusion Criteria:

* Central nervous system (CNS) metastatic disease (unless controlled and stable for at least 4 weeks), leptomeningeal disease, or cord compression.
* Clinically significant CNS dysfunction.
* Any other active malignancy within 3 years prior to enrollment.
* Prior treatment with anti-CD70 therapies.
* Current thyroid disorder (including hyperthyroidism) with the exception of hypothyroidism controlled on stable dose of hormone replacement therapy.
* Prior treatment with anti-CD52 monoclonal antibody in the past 12 months.
* Patients unwilling to participate in the extended safety monitoring period.
Prophylactic Infusion of Donor Lymphocytes in Cord Blood Transplantation

Pilot, multicentric, open-label, single-arm, phase I-II clinical trial to evaluate the safety and efficacy of a novel Umbilical Cord Blood Transplantation (UCBT) platform, that consists of a UCBT of the 80 fraction, followed by a Donor Lymphocyte Infusion (DLI) of the 20 fraction (between 60 and 90 days after transplantation).

Multicenter, open-label, single-arm, phase I-II pilot study in which a minimum of 20 patients will enter the study with the primary objective to assess the safety and secondary objective to assess efficacy in relation to immune reconstitution followed by a new platform of treatment consisting of initial cord blood unit 80 fraction transplantation, followed by a prophylactic donor lymphocyte infusion (DLI) of the fraction 20 of the cord blood unit. The second infusion will take place between 60 and 90 days after transplantation.

Eligibility Criteria:
Inclusion Criteria:

At the time of transplantation:

* Patients under 60 years with proposal UCBT according to assistance protocol
* Diagnosis of high-risk acute leukemia with an indication of allogenic transplantation
* Frozen UCB bag split into two bags: one with the 80% of the product and another with the 20%
* Presence of at least 1.2E9 total nucleated cells and\> 1E5 CD34 / kg and\> 6E6 CD34 + in fraction 80%
* 4/6 or better compatibility taking Human Leukocyte Antigen (HLA) HLA-A, HLA-B by antigenic resolution and DRB1 by allelic resolution
* The patient (or legal representative if required) has signed the informed consent

At the time of DLI:

* Documented cord blood engraftment
* The patient has had no Graft Versus Host Disease (GVHD) during the first 60 days post-transplantation or, if present, receives less than 10 milligrams of prednisone at the time of the DLI or \<0.2 mg / kg / day of prednisone for pediatric patients (\<16 years).
* The patient has less than 200 CD4 + cells per microliter on peripheral blood at 60 days (± 7 days) post-transplantation
* The patient (or legal representative if required) has signed the informed consent

Exclusion Criteria:

At the time of transplantation:

* Simultaneous participation in another clinical trial or treatment with other research phase product within 30 days prior to inclusion in the study.
* Pregnant women or those who intend to become pregnant within 12 months after the signing of the informed consent or not taking proper contraceptive measures according to investigator criteria.
* Breastfeeding women
* Other pathologies or circumstances that may compromise the patient's participation in the study according to the criteria of the investigator.

At the time of DLI:

* Grade III-IV GVHD after allogeneic UCB
* Prednisone treatment (\> 10 mg total per day in adults or\> 0.2 mg / kg / day prednisone for pediatric patients)
Different Modalities Interventions Post Supracondylar Humeral Fracture in Pediatrics

the aim of the study is comparing the effects of LLLT and PEMFT on range of motion of elbow and radioulnar joint ,pain ,muscles strength of upper limb and hand function in children with post-operative type II and III supracondylar humeral fracture.

intervention study describe the effects of low level laser and pulsed electromagnetic field in children with supracondylar humeral fracture . All children will be randomly classified by envelope method into two study groups of equal number. study group A and study group B. Both groups will receive designed physical therapy program, 20 minutes, 3 times per week for six weeks in addition to study group A will receive LLLT, 5 minutes and study group B will receive the same physical therapy program, in addition to PEMF, 20 minutes.

Eligibility Criteria:
Inclusion Criteria:

1. Age ranges from 6 to 10 years of both genders.
2. All subjects have unilateral extension type II and III supracondylar humeral fracture requiring closed reduction and percutaneous pinning (CRPP).
3. The study will be start immediately after removal the splint.
4. Children clinically and medically stable.
5. Children able to follow verbal commands.
6. Children sample will represent those children who enrolled in schools and other not yet.

   -

Exclusion Criteria:

The patients will be excluded if they have one of the following criteria;

1. Previous soft tissue injury at the same affected side of fracture.
2. Presence of associated fractures on the ipsilateral or contralateral upper limb.
3. Active infection near the fracture site.
4. Children with congenital or acquired skeletal deformities in the upper limbs.
5. Children with neurological deficits such as convulsions, involuntary movements, receiving muscle relaxants.

   -
Narcotics vs NSAIDs for Post-operative Analgesia in Outpatient Rhinoplasty

The purpose of this study is to compare the efficacy and safety of oral opiate pain medication vs non-steroidal ant inflammatory drugs (NSAIDs) in the treatment of postoperative rhinoplasty pain. This study will also evaluate potential contributing factors affecting the efficacy of these pain control methods. Patients will be randomized to receive either NSAIDs in the form of 400mg of Ibuprofen or Norco (hydrocodone 5mg- acetaminophen 325mg) to be used for post-operative pain. The study will then compare which is more effective in controlling post operative pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18-70 years old undergoing septorhinoplasty or rhinoplasty for either obstructive or aesthetic reasons. All approaches to rhinoplasty and surgical techniques utilized will be included. This will include patients that undergo additional procedures during the rhinoplasty including osteotomies, turbinate reduction, septoplasty, nasal valve repair and ear cartilage graft.

Exclusion Criteria:

* Patients who undergo a rhinoplasty requiring a rib cartilage graft for the procedure as this is known to cause significant pleuritic chest pain.
* Patients receiving functional endoscopic sinus surgery concurrently with the rhinoplasty will be excluded.
* Patients with known history of gastrointestinal bleeds, peptic ulcer disease or who have other comorbidities that prevent them from taking NSAIDs.
* Patients with a history of radiation, active head and neck malignancy or other pain disorders such as various rheumatologic diseases will be excluded to decrease confounding factors in the control of pain.
Flooring for Injury Prevention Trial

This study will evaluate the efficacy of novel compliant flooring in reducing injuries due to falls in a long-term care facility, determine the cost effectiveness of this intervention, and assess perceptions about compliant flooring among staff, residents, and families.

The investigators hypothesize that compliant flooring will (1) reduce the incidence of injuries due to falls in long-term care residents; (2) represent an overall cost-savings when material and implementation costs are considered relative to direct and indirect costs associated with injuries due to falls; and (3) be received positively by staff, residents, and their family members.

Falls are the number one cause of unintentional injury among older adults in Canada, and are responsible for economic costs in excess of $1 billion CAD annually. In high-risk environments, such as long-term care (LTC) facilities, 60% of residents will experience at least one fall each year. Moreover, approximately 30% of falls in LTC residents result in injury, and 3 to 5% cause fractures.

A promising strategy for reducing the incidence of fall-related injuries in LTC facilities is to decrease the stiffness of the ground surface, and the subsequent force applied to the body parts at impact. Purpose-designed compliant flooring can reduce the force applied to the hip during a fall by up to 35 % (to allow a raw egg to be successfully bounced without cracking). Yet, few LTC facilities have flooring designed to reduce the impact of falls. This study will address this gap.

Resident rooms at a local LTC facility will be randomly assigned to installation of compliant flooring or control (non-compliant) flooring. Following installation, primary and secondary outcomes, including fall-related injuries and falls, will be monitored for 4 years and compared between resident rooms with and without compliant flooring. In addition, health resource utilization and their costs will be compared between resident rooms with and without compliant flooring. Perceptions about compliant flooring will be assessed among staff, residents, and their families.

Eligibility Criteria:
Inclusion Criteria (for rooms):

* Resident rooms across four units at New Vista Society Care Home, a long-term care facility in Burnaby, BC, Canada

Exclusion Criteria (for rooms):

* Resident rooms across four units at New Vista Society Care Home in which new flooring cannot be installed
An Evaluation of JUST Court in Yuma County, AZ

Arizona has created a pilot program for juvenile probationers called Juveniles under Supervision and Treatment (JUST), which includes swift and certain, but modest responses, to technical violations of the terms of juvenile probation. JUST targets high- and medium-risk juvenile probationers and its stated objective is to reduce violations and overall incarceration of youth in the program. The JUST pilot is being implemented under the authority of the Arizona Governor's Office for Children, Youth and Families (GOCYF) and the Administrative Office of the Courts (AOC).

Arizona's Juveniles Under Supervision and Treatment (JUST) Court is a pilot project initiated by the Arizona Governor's office. It is designed to test whether the principles of Swift, Certain, and Fair (SCF) Supervision-clear rules, close monitoring, and swift and certain, but modest, penalties for each violation can succeed when applied to juveniles under community supervision. The Arizona Administrative Office of the Courts piloted JUST in two counties: Yavapai and Yuma. The Yuma program was launched in March 2011. The goal of JUST is to (a) reduce the violation rate so as to reduce the number of petitions filed to revoke probation (the purpose is to reduce the use of juvenile detention), and (b) reduce recidivism overall. All juveniles in Yavapai are supervised under JUST (evaluation using an RCT is therefore unfeasible). JUST in Yuma is now being scaled up, which affords the opportunity for an RCT. The goal of the RCT is to compare the performance of youth supervised under JUST with those supervised under probation-as-usual.

Eligibility Criteria:
Inclusion Criteria:

* Newly probated
* At least 13 years old
* No older than 17 years and 3 months
* At least nine months remaining on supervision
* Must be on standard probation with a supervision level of moderate to maximum
* Must be able to participate in the program for at least nine months

Exclusion Criteria:

* Not meeting all inclusion criteria
* Sex offender
* Dangerous offenses
A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial)

The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg plus Abacavir/Lamivudine once daily versus Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate (ATRIPLA® a trade mark of Bristol-Myers Squibb and Gilead Sciences LLC) over 48 weeks; non-inferiority will also be tested at Week 96. This study will be conducted in HIV-1 infected ART-naïve adult subjects. Long term antiviral activity, tolerability, safety, and development of viral resistance will be evaluated.

ING114467 is a Phase 3 randomized, double-blind, double dummy, active-controlled, multicenter, study conducted in approximately 788 HIV-1 infected ART-naïve subjects. Subjects will be randomized 1:1 one of the following treatment arms:

GSK1349572 50 mg plus abacavir/lamivudine fixed-dose combination once daily (approximately 394 subjects)

OR

Atripla once daily (approximately 394 subjects)

Analyses will be conducted at 48 weeks and 96 weeks. Subjects randomized to receive GSK1349572 and who successfully complete 96 weeks of treatment will continue to have access to GSK1349572 plus abacavir/lamivudine fixed-dose combination through the study until it is locally available-as long as they continue to derive clinical benefit, until they meet a protocol-defined reason for discontinuation, or until development of the compound is terminated.

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship

Eligibility Criteria:
Inclusion Criteria:

* Screening plasma HIV-1 RNA ≥1000 c/mL
* Antiretroviral-naïve (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection)
* Ability to understand and sign a written informed consent form
* Willingness to use approved methods of contraception to avoid pregnancy (women of child bearing potential only)
* Age equal to or greater than 18 years
* A negative HLAB\*5701 allele assessment

Exclusion Criteria:

* Women who are pregnant or breastfeeding;
* Active Center for Disease and Prevention Control (CDC) Category C disease
* Hepatic impairment
* HBV co-infection
* Anticipated need for HCV therapy during the study
* Allergy or intolerance to the study drugs or their components or drugs of their class
* Malignancy within the past 5 years
* Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
* Treatment with radiation therapy, cytotoxic chemotherapeutic agents or any immunomodulator within 28 days of Screening
* Exposure to an agent with documented activity against HIV-1 in vitro or an experimental vaccine or drug within 28 days of first dose of study medication
* Primary viral resistance in the Screening result
* Verified Grade 4 laboratory abnormality
* ALT \>5 xULN
* ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with \>35% direct bilirubin);
* Estimated creatinine clearance \<50 mL/min
* Recent history (≤3 months) of upper or lower gastrointestinal bleed