cyrilzakka/clinical-trials huggingface dataset:
Pharmacogenomics Testing in the Optimal Use of Supportive Care Medications in Stage III-IV Cancer

This early phase I trial studies how well a genetic test called pharmacogenomics works in directing the optimal use of supportive care medications in patients with stage III-IV cancer. Pharmacogenomics is the study of how genes may affect the body's response to and interaction with some prescription medications. Genes, which are inherited from parents, carry information that determines things such as eye color and blood type. Genes can also influence how patients process and respond to medications. Depending on the genetic makeup, some medications may work faster or slower or produce more or fewer side effects. Pharmacogenomics testing may help doctors learn more about how patients break down and process specific medications based on their genes and improve the quality of life of cancer patients receiving clinical care.

PRIMARY OBJECTIVES:

I. Evaluate patient perceptions surrounding their quality of life (QOL) prior to pharmacogenomics (PGx) testing and 3 months post PGx testing.

II. Understand the clinical utility/relevancy of PGx testing in cancer patients at Mayo Clinic Arizona from the viewpoint of their providers.

OUTLINE:

Patients undergo one-time collection of saliva sample for pharmacogenomics testing. Patients also complete quality of life assessment at baseline and at 3 months after pharmacogenomics testing.

After completion of study, patients are followed for up to 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Patient enrolled to Mayo Clinic IRB: 18-000326
* Patients with stage 3 or 4 breast, colorectal, prostate/genitourinary (GU), pancreato-biliary, brain, melanoma, and ovarian cancer
* Individuals have agreed to participate and signed the study informed consent form

Exclusion Criteria:

* Patients with cancer types other than the ones mentioned above
* Patient with psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent
* Previous PGx testing with results available within Mayo Clinic electronic medical record (EMR)
Impedance Cardiography During Major Abdominal Surgery

The investigators validated ICG's(impedance cardiography) usefulness during the abdominal surgery, by comparing it with FloTrac/Vigileo™ (Edwards Lifesciences,Irvine, CA, USA)

Intrathoracic structures have relatively constant resistance except the influence of changing diameter of aorta. Great vessels in thorax has the lowest resistance, and their diameter changes by the beats of the heart. As their diameter increases, their resistance decreases. ICG measures the difference between the resistances caused by heartbeats, and calculates cardiac output.

But during the surgery, there are many interfering electrical currents made by electro cautery, patient positioning, and internal organ handling. Therefore, it has been thought that ICG is not a valid tool for measuring cardiac output during the surgery.

The investigators validated ICG's usefulness during the surgery, by comparing it with Floctac/Vigileo.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing open gastrectomy with arterial line
* ASA 1 \& 2

Exclusion Criteria:

* severe valve disease
* severe lung disease
The Effect of Anesthetics Agents on Vascular Injury and Level of Syndecan-1 During Knee Surgery

Ischeic reperfusion injury lead to a cellular dyfunction and increase in soluble glycocalyx of blood flow. syndecan-1 was a marker of glycocalyx.

The purpose of this study is to prove the variation of level of serum syndecan-1 between preoperative and postoperative period.

The patients were allocated randomly to receive propofol or desflurane. Also, a total of 6ml of blood sample was obtained for total 6 times in consecutive order.

1. Preoperation (immediate before anesthesia induction)
2. Immediate before tourniquet off
3. 5 min after tourniquet off
4. PACU
5. postoperative 6 hours
6. postoperative 24 hours

Serum in blood will be obtained and level of serum cytokine will be evaluated by enzyme-linked immunosorbent assay

Eligibility Criteria:
Inclusion Criteria:

* patients who was planned to undergo knee surgery.

Exclusion Criteria:

* age \< 20 years old
* history of previous cancer
* history of previous peripheral vascular disease
* Emergency surgery
Clinical Trial to Evaluate the Safety and Pharmacokinetics of YHP1903 in Healthy Volunteers

A randomized, open-label, single dose, crossover clinical trial to evaluate the safety and pharmacokinetics of YHP1903 in healthy volunteers

32 healthy subjects wil be randomized one of 2 groups in the same ratio. Subjects in group 1 will be administered "comparator" and "YHP1903" by cross-over design on day1, 8.

Subjects in group 2 will be administered "YHP1903" and "comparator" by cross-over design on day1, 8.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male/female aged 19 to 55 with body mass index(BMI) between 18.5 and 30kg/m2
2. Acceptable medical history, physical examination, laboratory tests and EKG, during screening
3. Subjects who has signed a written informed consent voluntarily,prior to any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug

Exclusion Criteria:

1. History of clinically significant disease
2. Sitting blood pressure meeting the following criteria at screening:

   * 140 ≤ systolic blood pressure ≤90 (mmHg)
   * 90 ≤ diastolic blood pressure ≤ 60 (mmHg)
3. Have AST(SGOT) or/and ALT(SGPT) \> 1.5 times of normal upper limit or Total bilirubin \> 2.0 mg/dl at the time of screening
4. Volunteers considered not eligible for the clinical trial by the investigator
5. Administration of other investigational products within 6 month prior to the first dosing.
A Non-interventional, Observational Study for Quality of Life (Overall Health Assessment) in Patients With Chronic Severe Pain During Targinact® Treatment

This non-interventional, observational study evaluates the efficacy of Targinact with regard to quality of life in daily clinical practice in Belgium compared to the previous analgesic treatment.

Patients are treated with Targinact® according to daily clinical practice during at least 12 weeks and are monitored during study 3 visits. Parameters assessed are overall health assessment of the patient, pain relief, constipation, use of laxatives, use of analgesic rescue medication, use of concomitant medication, quality of life and safety of Targinact® treatment. These parameters, except for safety assessment, are compared between Targinact® treatment and previous analgesic treatment.

Eligibility Criteria:
Inclusion criteria:

Patients enrolled in the study are patients who

* are eligible for Targinact® treatment according to the Targinact® SPC AND
* who have previously been treated with WHO step 1, 2 or 3 analgesics

Exclusion criteria are based on the Targinact® SPC.
Prevalence of HPV-associated Eye Infection and Cytokine Levels in Tears From Patients Diagnosed With Pterygium

Prevalence of HPV-associated eye infection and cytokine levels in tears from patients diagnosed with pterygium

The main purpose of this study is to evaluate the prevalence of HPV infection in primary and recurrent pterygium and the association of HPV types collecting from conjunctiva swab and urine. The second purpose is to compare a quantity of cytokines including IL-6, IL-18 and growth factor including VEGF found in tears of patients with primary and recurrent pterygium to participants with free of ocular disease Primary hypothesis

- The prevalence of HPV infection in primary pterygium is difference with prevalence in recurrent pterygium patients.

Secondary hypothesis

* Ocular HPV infection has association with HPV genitalia infection.
* Tears cytokine and growth factor level (IL-6, IL-18 and VEGF) are higher in pterygium HPV infection than non-HPV infection and also more than normal population

Eligibility Criteria:
Participants as primary and secondary pterygium group

Inclusion Criteria:

* Age above 18 years old
* presence of pterygium invading the cornea

Exclusion Criteria:

* Other ocular inflammation that could affect the results of the study (such as conjunctivitis, keratitis, conjunctival tumor, etc) or would preclude the enrollment for safety reasons

Participant without ocular disease Inclusion criteria

* Age above 18 years old Exclusion criteria
* Presence of any ocular inflammation diseases
Pemetrexed in Maintenance in Patients With Impaired Renal Function, 2 Dose Calculation Strategies

Pemetrexed is used in the treatment of non-small cell lung cancer (NSCLC). Its elimination is mainly renal and its nephrotoxicity requires an interruption of treatment when the CrCLCG falls below 45 mL / min. Patients with NSCLC frequently have impaired renal function by other cytotoxic drugs.

The dose adjustment of pemetrexed is performed as a function of body surface area (SC) without any pharmacokinetic rational. The challenge is to treat patients with renal insufficiency (RR) with a safe dose, based on CRCL, providing equivalent biological exposure to patients with preserved renal function.

* Primary objective: Evaluate the impact of calculating the dose of pemetrexed to be administered versus creatine clearance according to Cockcroft-Gault (CrCLCG) versus body surface area (SC) on median time before discontinuation of treatment for renal function ≤ 45mL / min in patients treated for non-small cell lung cancer predominantly non-squamous in maintenance.
* Secondary objective: To evaluate the impact of calculating the dose of pemetrexed to be administered versus CRCLCG versus SC over time to treatment discontinuation, progression-free survival (PFS), and patient overall survival.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Patient with non-small cell lung cancer predominantly non-epidermoid histologically documented
* Patient who is scheduled to initiate treatment or undergoing maintenance therapy by pemetrexed
* Neutrophils\> 1500 / mm3; Chips\> 100,000 / mm3
* Informed, dated and signed consent For patients of childbearing age, effective contraceptive method
* Creatinine clearance according to the Cockcroft-Gault formula between 70 and 45 mL / min
* PS = 0 or 1

Exclusion Criteria:

* Patient with a contraindication to pemetrexed therapy
* Patient with symptomatic brain metastases
* Pregnant or nursing women
* Patient under guardianship or curatorship or subject to a system of protection for persons of full age
* Patient not affiliated to a social security scheme (beneficiary or beneficiary)
Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT

Questionnaire to be completed by patients coming for PET to identify the predictive factors of physiological hypermetabolism of the anal canal


Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years old
* Patient referred for 18F-FDG PET

Exclusion Criteria:

* History of surgery or anal and / or perineal and / or pelvic radiotherapy, whatever the indication
* Patient deprived of liberty, under tutorship or curatorship
* Any associated socio-educational, medical or psychological condition that could compromise the patient's ability to participate in the study (eg illiteracy, mental retardation, etc.)
* Pregnant woman (classic contraindication of a PET scan)
* Opposition of the patient to participate in the study
Optimal Analgesia in Acute Gastroenteritis

The purpose of this study is to find out an optimal way of analgesia in case of acute infectious gastroenteritis the investigators are going to compare two medicines that are used on everyday basis (without being ever before subject to scientifical study): Dipyrone and papaverine The study is done in the Emergency Department setting. Thus, only first 6 hours of treatment is included in study


Eligibility Criteria:
Inclusion Criteria:

* acute gastroenteritis
* VAS scale of pain perception at least 4

Exclusion Criteria:

* pregnancy
* allergy to any one of study preparations
* blood pressure less than 85 on admission
* surgical condition (acute abdomen) suspected or diagnosed
A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera

The study is designed to evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera (PV) in maintaining hematocrit control and in improving symptoms of PV.

Phase 3 study in approximately 250 subjects previously diagnosed with polycythemia vera (PV) who require phlebotomy on a routine basis. There is a 32-week period during which rusfertide or placebo will be added-on to each subject's ongoing therapy for polycythemia vera which may include phlebotomy only or phlebotomy plus stable doses of either of hydroxyurea, interferon and/or ruxolitinib. All subjects who successfully complete the double blind 32-week portion of the study will receive rusfertide for 124 weeks. Approximately 6 and 12 months after their last dose of rusfertide, subjects will have a post-study contact (e.g. by phone) for safety.

Eligibility Criteria:
Main Inclusion Criteria: All subjects must meet ALL of the following inclusion criteria to be enrolled. There are additional inclusion criteria.

* Male and female subjects aged 18 (or the country specific minimum age of consent \>18) years or older.
* Meet revised 2016 World Health Organization (WHO) criteria for the diagnosis of polycythemia vera.
* At least 3 phlebotomies due to inadequate hematocrit control in 6 months before randomization or at least 5 phlebotomies due to inadequate hematocrit control in 1 year before randomization.
* CBC values immediately prior to randomization:

  1. Hematocrit \<45%,
  2. WBC 4000/μL to 20,000/μL (inclusive), and
  3. Platelets 100,000/μL to 1,000,000/μL (inclusive)
* Subjects receiving cytoreductive therapy at randomization must be on a stable PV therapy regimen.
* Subjects treated with phlebotomy alone at randomization must have stopped cytoreductive therapy 2 to 6 months before screening.

Main Exclusion Criteria: Subjects must meet NONE of the following exclusion criteria to be enrolled. There are additional exclusion criteria.

* Clinically meaningful laboratory abnormalities at Screening.
* Subjects who require phlebotomy at hematocrit levels lower than 45%.
* Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 2 months prior to randomization.
* Active or chronic bleeding within 2 months prior to randomization.
* History of invasive malignancies within the last 5 years, except localized cured prostate cancer and cervical cancer.
* Subjects with in situ or stage 1 squamous cell carcinoma of the skin, in situ or stage 1 basal cell carcinoma of the skin, or in situ melanoma of the skin identified during screen unless the cancer is adequately treated before randomization.
* Received Busulfan, Pipobroman or 32Phosphorus within 7 months prior to screening.
Registry of Angiovac Procedures In Detail Outcomes Database-RAPID Registry

Venous thromboembolic disease is a significant cause of morbidity and mortality. The purpose of the RAPID registry is to collect information on the Angiovac procedure and Angiovac device used in the treatment of deep venous thrombosis (DVT), right heart pathology and pulmonary embolism.

Venous thromboembolic disease is a significant cause of morbidity and mortality. Thrombolytic therapy has been shown to be a successful treatment modality, however its use is somewhat limited due to the known risk of hemorrhage (overall 22%, with up to 3% intracranial hemorrhage), and suggested risk of distal embolization where large mobile thrombi are encountered. In patients where either thrombolysis is contraindicated or unsuccessful and conventional therapies inadequate, bulk thrombectomy may be considered. Until recently this was primarily achieved with surgical thrombectomy; however the Angiovac device is posited to offer a minimally invasive alternative.

This registry will collect data on patients in whom the Angiovac device was placed into the body for management of inferior vena cava (IVC) clots, right atrial (RA) masses or pulmonary emboli (PE) will be included.

This registry is to capture high quality patient safety and effectiveness data on use of the Angiovac device for 3 separate, but overlapping conditions; a) Iliofemoral and Caval DVT, b) Right heart masses, and c) PE. The goal will be achieved by capturing a concise set of immediate and short-term functional and clinical outcome data for all patients who have the angiovac catheter deployed into the vascular system.

Any center performing Angiovac procedure and wishing to contribute patient data will be offered participation in the registry. These core sites will be required to submit the registry protocol for Institutional Review Board (IRB) review. Once documentation of IRB approval has been received, centers may transmit their data via secure REDCap (Research Electronic Data Capture) database in accordance with federal regulations in the Health Insurance Portability and Accountability Act (HIPAA

Eligibility Criteria:
Inclusion Criteria:

* All patients in whom the Angiovac device was placed into the body for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.

Exclusion Criteria:

* Angiovac device not deployed
Fertility Preservation in Cases of Klinefelter Syndrome.

Klinefelter Syndrome (KS) is the most common sex chromosomal abnormalities (1/600 newborn males), and is characterized by a hypergonadism hypogonadism. Until few years ago, mostly non-mosaic KS was considered as a model of a complete male infertility although few KS (4-8%) have an oligospermia. Recent studies in adult with non-mosaic KS reported the possibility of sperm retrieval by testicular biopsy (TESE) in around 50% cases and more than some pregnancies have been obtained after TESE with Intracytoplasmic Sperm Injection (ICSI). Since 1997, more than one hundred births are described.

As some studies shown a decrease of successful sperm retrieval with the increasing of age, we plan to compare the potential of sperm retrieval between two groups "adult" (23-55 years) and "young" after the onset of puberty (15-22 years). The study will be performed by searching spermatozoa on two seminal analyses spaced out 3 months followed by a testicular biopsy if the azoospermia is confirmed on semen analyses.


Eligibility Criteria:
Inclusion Criteria:

* Klinefelter Syndrome with 47,XXY non-mosaic
* Androgenotherapy stopped since more than 6 months

Exclusion Criteria:

* Antecedent of Radiotherapy or chemotherapy
* Psychological trouble
* Treatment interfering with spermatogenesis
* Androgenotherapy non stopped
Early Active Finger Exercises in Replanted Fingers

A controlled randomized trial, including patients undergoing finger replantation surgery. The Control Group will receive a standardized post operative rehabilitation regime, whilst the Intervention Group will receive a rehabilitation regime that includes early active exercises of the replanted digits.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Total or subtotal amputation injury of 1-4 of the four ulnar digits
* Injury distal to the MCP joint
* Must have injured flexor tendon which requires suture
* Must have a fracture
* Surgery done with a stable osteosynthesis with acceptable post-operative x-ray imaging
* The finger must have had a stable circulation for at least 5 days post-surgery

Exclusion Criteria:

* Arthrodesis/temporary fixation of the MCP joint
* Bilateral amputation injury
* Severely damage of other parts if the hand compromising the patient's ability to perform active exercises of the fingers
* Patients who cannot follow the planned controls
Jazz Music and Mindfulness for Chronic Pain

Chronic pain, including spinal pain and osteoarthritis, is the leading cause of years lived with disability world-wide and the costliest health condition in the U.S. today. Compounding these concerns, opioid analgesics remain the primary pharmacological treatment for chronic pain. An estimated 21-29% of chronic pain patients receiving long-term opioid therapy develop opioid misuse, and opioid misuse portends addiction and overdose. Clearly, chronic pain patients need better, non-addictive treatment options designed to reverse the downward spiral of chronic pain.

Group Assignments

Participants will be randomized into one of three groups.

1. Jazz Group 1: Participants in this group will watch an introduction to jazz appreciation video prior to the 4-week intervention.
2. Jazz Group 2 (Mindful Jazz) Group: Participants in this group will watch a video on mindful listening to jazz.
3. Music Waitlist Group: Participants in this group will serve as a control and will not receive any intervention until the study is completed. They will complete a baseline survey and a follow-up survey at four weeks. Some videos will be sent to this group after the study is completed, without tracking their usage.

Intervention

All groups will complete a baseline and 4-week follow-up survey.

Participants in Jazz Group 1 and Jazz Group 2 will engage in daily listening 4-week intervention.They will have access to electronic audio recordings, with the order of listening labeled for each day. It is up to them if they want to listen to the daily recordings.

Eligibility Criteria:
Inclusion Criteria:

1. Are 18+
2. Live in the US
3. Are an English-proficient adult with a chronic pain diagnosis (no restrictions placed on type)
4. Have a pain rating of four or greater in average pain on a 0-10 numeric rating scale in the preceding week
5. Have had pain for at least 3 months and for at least 15 days in the preceding 30 days
6. Have moderate to severe anxiety based on GAD-7

Exclusion Criteria:

1. Are currently using or have used prescription opioids in the past 3 months to minimize a known treatment confound and increase sample homogeneity
2. Have a current cancer diagnosis
Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants

During their first year of life, children spend more than half their time sleeping, a function essential to their neurodevelopment. This period of maturation and development of the future adult is considered extremely vulnerable to environmental exposure. During this period, the child\&#39;s diet is mainly provided by breastfeeding, where persistent chemical substances have been found. A cocktail of 19 mostly persistent substances (POPs) present in breast milk has recently been identified as the main contributor to neurodevelopmental risk. However, the reality of their impact on neurophysiological development, in particular on infant sleep, has yet to be assessed.

In this project, the sleep of children under 6 months of age will be studied using an actimetry watch worn for 7 days by the child, accompanied by a sleep diary. Exposure to environmental pollutants will be assessed by measuring their presence in the infant\&#39;s milk (breastfeeding) and wearing a silicone bracelet to collect air pollutants. A questionnaire on exposure will complement this evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Infant less than 6 months of age still on milk diet (total)

Exclusion Criteria:

* Infants with neurological or neurobehavioral disorders
* Families who wish to relocate within 7 days of inclusion
* Minor parents deprived of their parental rights, not understanding French, in a state of stress, overwhelmed or vulnerable.
* Non-affiliation to a social security system