cyrilzakka/clinical-trials huggingface dataset:
Anesthesia and Cancer Recurrence im Malignant Melanoma

Studies in animals and retrospective studies in humans show that regional anesthesia reduces metastatic cancer dissemination.

The investigators hypothesize that in patients suffering from malignant melanoma who have to undergo radical inguinal lymph node dissection immune function will be less compromised and long term survival will be superior when spinal anesthesia is compared to general anesthesia.

Results of basic science indicate that regional anesthesia prevents perioperative immunosuppression and reduces postoperative metastatic cancer dissemination. If this would occur in humans, optimised anesthetic management might improve long-term outcome after cancer surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for inguinal lymph node dissection because of malignant melanoma of the lower limb
* Signed informed consent

Exclusion Criteria:

* Age \< 18 years
* Female patients who are pregnant or nursing
* Multiple organ failure
* Contraindications
Exploring Semi-Quantitative Pregnancy Tests and Their Impact on Reproductive Health Service Provision

This study will examine the feasibility, practicality, utility and usability of a semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit) recently approved by the food and drug administration (FDA) for both Professional (physician office) and over-the-counter (consumer) use. The study seeks to:

1. Assess the correlation of this pregnancy test results with serum values (as distinct from urine) hCG.
2. Assess whether or not time of day of urine collection has any impact on the outcome of the dBest test.
3. Assess user comprehension of the pregnancy test, especially assessment of the result.

This study will examine the feasibility, practicality, utility and usability of a semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit) recently approved by the food and drug administration (FDA) for both Professional (physician office) and over-the-counter (consumer) use. The study seeks to:

1. Assess the correlation of this pregnancy test results with serum values (as distinct from urine) hCG.
2. Assess whether or not time of day of urine collection has any impact on the outcome of the dBest test.
3. Assess user comprehension of the pregnancy test, especially assessment of the result.

Eligibility Criteria:
Inclusion Criteria:

* Women 18 years or older, presenting for early abortion, pre-natal care, or fertility services.
* If pregnant, gestational age \< 84 days by LMP, ultrasound or clinical assessment.
* Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up.
* Able to consent to study participation.

Exclusion Criteria:

* Women less than 18 years of age.
* Women who are not pregnant, except if presenting for IVF services.
NIRS Monitoring to Detect AKI in Preterm Infants

This study will examine the relationship of oxygen levels, using Near-infrared spectroscopy (NIRS) monitoring, and kidney injury in infants born prematurely. NIRS is a skin sensor which detects the amount of oxygen going to different organs, most often used to monitor the brain and kidney.

This prospective, single-center study was conducted at UnityPoint Health-Meriter Hospital (Madison, WI, USA) in preterm neonates admitted to a level III NICU from April 2018 to August 2019. The primary study aim was to assess changes in RrSO2 with continuous renal NIRS monitoring to detect AKI during the first 7 days of age.

The INVOS 5100 C (Somanetics, Troy, MI, USA) four channel NIRS monitors were used to measure RrSO2 (measured at the right or left flank) and Cerebral regional Somatic tissue Oxygenation (CrSO2; measured at the forehead) for all neonates. At each measurement site, for skin protection, subjects had a transparent Mepitel (with Safetac Technology, Norcross, GA) adhesive dressing placed with the adhesive neonatal NIRS sensor (INVOS OxyAlert NIRSensor, Covidien) adhered over the Mepitel dressing. Neither cerebral or kidney sensors were placed with ultrasound guidance. Tissue oxygenation was recorded every 3 seconds until 7 days of age, and the sensor was changed one time when the patient reached three to four days of age per the company's recommendation. There were no restrictions on positioning or handling of neonates; nurses re-positioned neonates every 3-6 hours per unit protocol to prevent skin pressure injuries. Researchers, staff, and parents were blinded to RrSO2 values.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants \< 32 weeks
* Admitted to Unity Point Health(UPH) Meriter Newborn Intensive Care Unit (NICU)
* Application of NIRS by 48 hours of age

Exclusion Criteria:

* Congenital anomaly of the kidney or urinary tract (CAKUT)
Study for HER2-Overexpressed MBC Patients Treated by Cipterbin® Plus vinorelbinE

Breast cancer is the most common malignant disease and the most frequent causes of cancer mortality in females worldwide. The situation is same as the world in China. Trastuzumab has been proved valuable treatment for HER2-positive breast cancer patients. Cipterbin® is developing by Shanghai CP Guojian Pharmaceutical Co.Ltd.Now we carried on the phase III trial in order to prove Cipterbin® 's efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

* signed ICF
* pathologic diagnosis breast cancer
* HER2+ status defined as IHC3+ Staining or in situ hybridization positive at least 1 measurable lesion as per RECIST criteria age from 18y to 70y KPS\>=70

Exclusion Criteria:

* More than three prior chemotherapy lines for advanced disease LVEF\<50%
* prior exposure vinorebine for breast cancer
* prior exposure Trastuzumab for breast cancer
* uncontrolled brain metastasis
* breastfeeding or pregnant
Assessing the Impact of Opioid-Free Anesthesia Using the Modified Mulimix Technique.

The effective management of post-operative pain in the setting of bariatric surgery presents significant hurdles for both anesthesiologists and surgeons. The objective of this study was to assess the effects of opioid-free anesthesia (OFA) using the modified mulimix technique on the levels of plasma interleukin-2 (IL-2) and interleukin-6 (IL-6) as the primary outcome. Additionally, the study aimed to evaluate the duration of analgesia and the analgesic requirements within the first twenty-four hours after surgery.

Objectives: The effective management of post-operative pain in the setting of bariatric surgery presents significant hurdles for both anesthesiologists and surgeons. The objective of this study was to assess the effects of opioid-free anesthesia (OFA) using the modified mulimix technique on the levels of plasma interleukin-2 (IL-2) and interleukin-6 (IL-6) as the primary outcome. Additionally, the study aimed to evaluate the duration of analgesia and the analgesic requirements within the first twenty-four hours after surgery.

Methods: 60 patients were systematically selected and randomly assigned to Group A (OFA) and Group B (Opioid-Containing Anesthesia, OCA), with the modified Mulimix technique employed. Serum samples were collected from all patients, both at the onset of the skin incision and after the surgical procedure. These samples were then used to assess interleukin-2 (IL-2) and interleukin-6 (IL-6) levels. Additionally, the post-operative analgesic consumption was documented.

Eligibility Criteria:
Inclusion Criteria:

* both genders
* aged between 20 and 50 years
* patients fall under the American Society of Anesthesia (ASA) categories II-III
* body mass index (BMI) ranging from 35-50.

Exclusion Criteria:

* patients who declined participation in the trial
* pregnant women
* patients who encountered challenges in communication that could potentially impede a dependable postoperative evaluation
DEBOXA for Inoperable NET Liver Metastases

A prospective clinical trial to study the safety and effectiveness of Transcatheter Artery Chemotherapy and Embolization (TACE) using CalliSpheres Drug-Eluting Beads with oxaliplatin (DEBOXA) in treating patients who have inoperable neuroendocrine neoplasm (NEN) liver metastases.

OBJECTIVES:

I. Determine the safety and effectiveness of Transcatheter Artery Chemotherapy and Embolization (TACE) using CalliSpheres Drug-Eluting Beads with oxaliplatin (DEBOXA) in patients with inoperable neuroendocrine neoplasm (NEN) liver metastases.

II. Determine the response rate (RR) of intrahepatic lesions in patients treated with this regimen.

III. Determine the overall survival (OS), progression-free survival time (DFS), time to hepatic progression (THP), and quality of life (QOL) in patients treated with this regimen.

IV. Safety assessment: adverse events (AEs) and severe adverse events(SAEs)

OUTLINE: This is a single-arm, multi-center, prospective study.

Patients receive D-TACE. Embolization agent: CalliSpheres Drug-Eluting Beads. Chemotherapy agent: oxaliplatin. Treatment repeats every 5 weeks in the absence of progression of hepatic lesions, or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis is confirmed by biopsy or clinical data, primary site is resected or primary site is not resected but without risks of bleeding, obstruction in the near future.
* Failure of ≥ 1 system treatment, such as long-acting somatostatin or EP chemotherapy regimen.
* Standard surgical resection can not be performed because of extent liver involvement （liver involvement ≥ 2 lobes or ≥ 2 major vessels）, or patients who are not willing to accept surgical operation.
* Predicted survival \>3 months.
* Child Pugh Score: ≤ 7
* ECOG score for performance status: 0-1
* Informed consensus is achieved.

Exclusion Criteria:

* Metastases to other organs or sites besides liver.
* Prior TACE for liver tumors in 1 year.
* Obvious hepatic arterio-venous shunt or arterio-portal shunt.
* Prior or concurrent malignancy (Except basal carcinoma or squamous carcinoma of skin or carcinoma in situ of cervex uteri which has been cured).
* Platelet count \< 50,000/mm\^3 or white blood cell count \<3,000 /mm\^3 without hypersplenism.
* Creatinine greater than upper limit of normal (ULN)
* AST or AST \> 5 times ULN
* Compromised coagulation: INR (International normalised ratio) \>1.5, current anti-coagulation therapy or hemorrhagic disorders.
* History of severe diseases involving heart, kidney, marrow, lung or central neural system.
* Infection diseases which need antibiotics treatment before less than 1 month.
* Co-existing morbidity or social environment which may lead patients not to obey study protocol or threat patients' safety.
Kinesiotape on Quadriceps and Gluteus in Counter Movement Jump and Sprint in Soccer Players

The main objective of this study is to analyse the effect of KT on countermovement jump (CMJ) and sprint immediately and 24 hours after its application on the quadriceps and gluteus maximus.

Kinesiotape (KT) is a technique commonly used in sports practice. It may be beneficial in enhancing muscle function by additional cutaneous afferent stimulation. The objective of this study was to analyze the effect of KT on countermovement jump (CMJ) and 20-m sprints immediately and 24 hours after its application on the quadriceps and gluteus maximus. A total of 37 male soccer players (19.7 ± 0.9 years old) were randomly assigned to one of 3 groups: experimental group: KT activation (KTact), placebo group: sham tape (KTst), and control group (CG). Participants performed a 30-minute preliminary warm-up, after which they conducted CMJ and 20-m sprint tests. These tests were repeated later (with KT application or not) and after 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* soccer players;
* age of 18-25 years;
* a regular attendance at training sessions

Exclusion Criteria:

* history of L1-L5 radiculopathy or lumbo-sacral pathology ;
* any treatment with KT on quadriceps or gluteus in the month prior to the study;
* history of systemic diseases that may affect the nervous system, musculoskeletal injuries or surgeries in the lower limb during the year prior to the study;
* use of analgesics or nonsteroidal anti-inflammatory drugs.
A Single-arm Safety Study of Transplantation Using Umbilical Cord Blood and Human Placental-derived Stem Cells From Partially Matched Related Donors in Persons With Certain Malignant Blood Diseases and Non-malignant Disorders

To investigate the safety of partially matched related human placental-derived stem cells (HPDSC) administered in conjunction with umbilical cord blood (UCB) stem cells from the same donor in subjects with various malignant or nonmalignant disorders potentially curable with stem cell transplantation and to assess potential restoration of normal hematopoiesis and immune function in subjects with these disorders


Eligibility Criteria:
Inclusion Criteria:

* suitable UCB collected from partially or fully HLA matched related donor
* subject requires umbilical cord transplantation

Exclusion Criteria:

* any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
* major anticipated illness or organ failure incompatible with survival from stem cell transplant
Drug-Drug Interaction Study in Healthy Adult Volunteers

The primary objective of this study is to assess the effects of cyclosporine on the pharmacokinetics of K-877 in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
* Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
* Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges or is showing no clinically relevant deviations, as judged by the investigator at Screening.

Exclusion Criteria:

* Subject has clinically relevant abnormalities in the screening or check in assessments.
* Subject has a blood pressure (as measured at Screening during the collection of vital signs) after resting supine for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic (for males) and 50 mm Hg diastolic (for females).
* Subject has a supine pulse rate (as measured at Screening during collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute.
Germline BRCA1 and BRCA2 Mutations in Jewish Women Affected by Breast Cancer

The purpose of this project is to further characterize inherited predisposition to breast cancer mediated by specific BRCA alleles (BRACA1 185delAG and 5382insC; BRCA2 6174delT) among Jewish women.


Eligibility Criteria:
Inclusion Criteria:

* Patients are eligible for the study if they are over 18 years of age, identify their ancestry as Jewish (both Sephardic and Ashkenazi Jews are eligible), have or have had a diagnosis of breast cancer, and are able to give informed consent.
* Relatives, age 18 or older, of the patients who meet eligibility criteria above and are found to have a specific BRCA1 or BRCA2 mutation if they are able to give informed consent.
Lung Cancer Screening Program in Mexico

This prospective study aims to detect early-stage lung cancer using low-dose computed tomography (LDCT) in Mexicans aged 50 or older who are current or former heavy smokers, non-smokers exposed to significant wood smoke, or diagnosed with COPD. Annual LDCT, spirometry, and serum biomarker tests will be conducted over 3 years, and a follow-up lasting up to 10 years.

This prospective cohort study aims to detect lung cancer in early stages using LDCT scans in Mexican individuals aged 50 years or older. Eligible participants comprise current smokers with a history of ≥ 20 pack-years, former smokers who have quit within the past 15 years, non-smokers exposed to wood smoke more than 100 hours/year, or patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD).

Secondary objectives include assessing the 10-year mortality rate, the association of lung cancer with immunologic biomarkers, the demographic characterization of participants, the psychological impact of an LC screening program, the histological profiling of positive cases, lung function changes in at-risk individuals, and the clinical staging distribution at diagnosis.

The study will conduct annual LDCT scans, lung function tests (spirometry), anxiety and depression assessments, and serum biomarkers tests over 3 years. Positive LDCT results will adhere to LUNG-RADS guidelines and be managed by a multidisciplinary team. Prevention strategies, including tobacco cessation treatments, will be provided. Follow-up will continue for 5 and 10 years or until an event of completion occurs (cancer diagnosis, end of follow-up, or death).

Eligibility Criteria:
Inclusion Criteria:

Eligible participants over fifty years old and one of the next criteria:

* Current smokers (\>20 pack-years)
* Former smokers (\>20 pack-years) who have quit within the past 15 years,
* Non-smokers exposed to wood smoke more than 100 hours/year
* Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD).

Exclusion Criteria:

* Subjects who cannot be examined by tomography due to physical limitations such as weight.
* History of any type of cancer within the last five years, except non-melanoma skin cancer.
* Symptoms consistent with some malignant neoplasm.
* People with a poor physical-emotional condition that reduces their life expectancy or does not ensure adherence to the study.

Elimination Criteria

• Withdrawal of informed consent
Exploring and Establishment of Combined Extracorporeal Life Support(CELS) in Critically Ill Children

Multiple organ failure (MODS) is still the leading cause of death in children in ICU. The treatment of MODS is mainly organ function monitoring and organ replacement therapy. Life support technology in vitro mainly includes mechanical ventilation, continuous renal replacement therapy (CRRT), non-biological artificial liver and extracorporeal membrane oxygenation technology (ECMO). However, critically ill patients who have multiple organ failure often require multiple organ support meanwhile. Combined extracorporeal life support (CELS) is still in its infancy to be applied in the treatment of critical illness due to nonstandard technology and theory without key breakthroughs and evidence-based medicine in the treatment of severe children organ failure.Solving the system problems supported by CELS can effectively reduce the mortality and disability rate of critically ill children and enhance health care in Shanghai, even across China.

The whole study is described below. To investigate the timing ,curative effect and mode of CRRT and ECMO treatment for critically ill children,we choose sepsis children especially those who are combined with septic shock as research object.

Furthermore,refractory shock is the therapeutic indications of ECMO. According to their clinical manifestation and severity of the disease,they are treated by CRRT or/with ECMO in a non-randomized way.

Comparing the laboratory index and prognosis of critically ill children treated by CRRT and those treated by ECMO,we aim to investigate the the timing ,curative effect of ECMO in the treatment of septic shock especially refractory shock.

The critically ill children who treated by CRRT are divided into three groups according to their treatment mode of CRRT. The laboratory index and prognosis are also be compared to investigate curative effect of CRRT in the treatment of septic shock.

The study also include severe sepsis children without CRRT or ECMO treatment as a control group.

Eligibility Criteria:
Inclusion Criteria:

* Children with severe sepsis and refractory shock admitted to the PICU of four study centers.

The informed consent of the guardians

Exclusion Criteria:

* active hemorrhage difficult catheter placing Irreversible brain damage patients enrolled in other clinic trial
Pramipexole and Morphine for Renal Colic

Opioid analgesics are among the most commonly prescribed class of medications in the US. While opioids may effectively control pain and other sensory disorders under acute conditions, the rates of misuse/abuse and accidental overdose have reached epidemic proportions. Clinicians are being challenged to find alternatives to opioid analgesics, or to reduce their use in treating pain whenever possible. Pre-clinical studies have shown that combining morphine (opioid drug) with pramipexole (dopamine 3 receptor agonist with some D2/D4 action) provides superior analgesia against painful stimuli than morphine alone. This analgesia is maintained even when the dose of morphine is lowered to a dose that is not effective on its own. A recent case report describes the use of this combination to restore pain control in a patient with restless legs syndrome, for which opioids alone have lost their effectiveness (Happe S, Clemens S and Brewer KL, In Review). This application proposes to establish a new therapeutic approach for treatment of a pain associated with renal colic (a common painful condition) using a novel combination of 2 existing, FDA-approved drugs. The immediate goal is to demonstrate that this drug combination can provide similar analgesia to opioid alone, and that analgesia is maintained when the opioid dose is reduced by 50%.

This is a double-blinded randomized controlled trial to take place in the Vidant Medical Center (VMC) Emergency Department (ED). A convenience sample of 96 participants will be drawn from patients presenting to the ED presentation with pain associated with suspected renal colic who do not experience pain relief after initial treatment with nonsteroidal anti-inflammatories.

Written informed consent will be sought by a study team member after screening to ensure all inclusion criteria and no exclusion criteria are met. Once a patient has consented, they will be randomized into 1 of 2 study arms: Arm 1 (Control arm) = 0.1mg/kg of intravenous morphine + placebo pill, single dose Arm 2 (Study arm) = 0.05mg/kg intravenous morphine + 0.25mg pramipexole, single dose. Both arms include a maximum dose of 10mg/kg for the IV morphine. Pain scores will be obtained prior to administration of study drugs, and at 15-minute intervals (+/- 2 mins) after treatment for up to 2 hours, or discharge from the ED. Subjective response to each drug treatment will also be assessed every 15 minutes (+/- 2 mins) after treatment for up to 2 hours, or discharge from ED. Morphine will have a max dose of 10mg IV.

Eligibility Criteria:
Inclusion Criteria:

* Age 19 - 65
* ED presentation with pain associated with suspected renal colic
* Patient reported failure to achieve pain relief with NSAID treatment in ED (additional pain treatment needed per treatment team)

Exclusion Criteria:

* Age \< 19 or ≥ 66
* Allergy to any study medication
* Known pregnancy or breastfeeding
* Received opioid prior to enrollment
* Received IV Lidocaine during current ED visit
* Known chronic renal disease
* Currently taking any dopamine receptor agonist or antagonists (Do I need to list?)
* Unable to consent