cyrilzakka/clinical-trials huggingface dataset:
Precision Chemotherapy Based on Organoid Drug Sensitivity for Colorectal Cancer

The purpose of this study is to investigate whether chemotherapy guided by patient-derived tumor organoid drug test can improve the outcomes of stage IV colorectal cancer.

Fluorouracil-based chemotherapy is the standard treatment for stage IV colorectal cancer patients. However, the effects of chemotherapy remains limited. Patient-derived tumor organoids are increasingly used as tools for drug test and predicting drug response in the clinic, and have been showed to faithfully predict clinical outcomes of patients with CRC. A prospective clinical trial is needed to validate whether the in vitro sensitivity to chemotherapy regimens in organoids drug test is associated with a longer PFS in stage IV colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70
* Histological confirmed colorectal cancer
* Stage IV
* American Society of Anesthesiologists (ASA) score I\~III
* No contraindication for chemotherapy
* No evidence of other malignant tumor

Exclusion Criteria:

* Refusing chemotherapy
* Pregnant or breast-feeding women
* Severe organ damage after chemotherapy, surgery or unable to continue to systemic chemotherapy
Magnesium Sulfate as an Adjunctive Analgesic in Prostate Surgery

The purpose of this clinical trial is to determine if receiving magnesium sulfate as an adjunctive analgesic for prostate surgery is effective in reducing pain. Subjects will be randomized to receive magnesium or not receive it, as part of a standardized general anesthetic for prostate surgery. The primary objective is to demonstrate improved pain scores in patients receiving magnesium sulfate as an adjunctive analgesic during surgery. Secondary objectives include demonstrating reduced requirements for other opioids, reduced postoperative shivering, improved discharge home and adequate neuromuscular blockade reversal, measured by quantitative train of four monitoring.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and older.
2. Undergoing a robotic prostatectomy under general anesthesia.
3. Is willing and able to provide consent to participate in the study.

Exclusion Criteria:

1. Patients younger than 18 years
2. Patients with end-stage renal disease
3. Known allergy to magnesium sulfate preparations
4. Any patient that the investigators feel cannot comply with all study related procedures
Progesterone Supplementation for HIV-positive Pregnant Women on Anti-Retrovirals

In pregnancy, cART is considered optimal for maternal health and for preventing the emergence of resistance that could compromise further care. In Canada, the majority of HIV-positive pregnant women receive a PI-based cART regimen. In the past, therapy was generally deferred until after the first trimester (if not required for maternal health) to minimize any unknown risk of teratogenicity. However, as treatment is now started earlier in HIV infection and as perinatal transmission rates are lowest in those with prolonged suppression of viral load during pregnancy, women are increasingly commencing cART either before conception or earlier in pregnancy.

Multiple reports and cohort studies provided data suggesting an association between PI-based cART use and preterm birth, low birth weight, and small for gestational age (SGA) babies, although conflicting data exist.

In the general population progesterone supplementation is widely used, is well tolerated, is considered safe, and is beneficial to prevent recurrent pre-term birth and increase birth weight. The investigators experimental findings suggest that PI use during pregnancy is associated with declines in progesterone levels that correlate with fetal growth, and that progesterone supplementation can improve PI-induced fetal growth restriction. The investigators preliminary findings in HIV+ pregnant women suggest that PI-use is associated with declines in progesterone levels, which correlate with birth weight percentile. Since HIV-positive women have higher rates of pre-term delivery and low birth weight that may be magnified by the use of PIs, then progesterone supplementation could be of benefit to neonatal health in the context of HIV-positive pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Documented HIV-1 infection
* On (stable) or initiating a cART regimen containing either ritonavir-boosted lopinavir (LPV/r), atazanavir (ATZ/r) or darunavir (DRV/r)
* Pregnant up to 24 weeks gestational age
* Singleton pregnancy
* 18 years or older
* Ability to give informed consent

Exclusion Criteria:

* Hypersensitivity or allergy to soya or peanut (non-active ingredient supplement in Prometrium)
* Contraindications to intravaginal progesterone use including:

  * documented hypersensitivity to Prometrium
  * active or history of breast cancer,
  * active or history of arterial thromboembolitic disease (e.g. stroke, myocardial infarction, coronary heart disease)
  * active or history of venous thromboembolism (e.g. deep venous thrombosis or pulmonary embolism) or active thrombophlebitis
  * any prior neoplasia, except for skin
  * abnormal vaginal bleeding
* Known lethal fetal anomaly
* Any contraindication to continuation of pregnancy
* Inability to communicate in English
* Prior participation in this trial
An Observational Study to Assess Change in Disease Activity and Adverse Events in Adolescent and Adult Participants With Moderate to Severe Active Crohn's Disease (CD) in Japan

Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world. Adverse events and change in disease activity will be assessed.

Upadacitinib is a drug approved for the treatment of CD. All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 240 participants will be enrolled in Japan.

Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 64 weeks.

There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with moderately to severely active Crohn's disease (CD).
* Has been prescribed upadacitinib for CD as per most current local approved label after its approval for CD in Japan.
* Within 14 days from the commencement of upadacitinib induction treatment for CD at the participating institution.

Exclusion Criteria:

* Currently participating in another interventional clinical research.
* Participants for whom upadacitinib is contraindicated.
* Has been treated with upadacitinib for CD before and continue treatment with upadacitinib for CD at the participation to this study.
Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis

OBJECTIVES:

I. Compare the efficacy of low-dose oral pulse methotrexate (MTX) and ursodiol versus colchicine and ursodiol in patients with primary biliary cirrhosis (PBC).

II. Determine the optimum dose and duration of MTX treatment.

III. Investigate the role of fibrogenic cytokines (FC) in PBC pathogenesis and the effect of treatment on FC production.

PROTOCOL OUTLINE:

This is a randomized, double-blind study. Patients are stratified by prior/concurrent medical management.

Patients in the first group are treated with oral methotrexate 3 times a week and a daily oral placebo.

Patients in the second group are treated with daily oral colchicine and an oral placebo 3 times a week.

Therapy continues for 10 years. Beginning year 2, daily oral ursodiol is administered to all patients. Patients with disease progression are crossed to the alternate group or undergo liver transplantation if clinically indicated.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Biopsy proven primary biliary cirrhosis (PBC); Disproportionate increase in alkaline phosphatase; Positive antimitochondrial antibody test OR Symptoms consistent with PBC, e.g.: pruritus, fatigue, malaise, jaundice, elevated bilirubin

No clinically advanced PBC, i.e.: bilirubin greater than 10 mg/dL or albumin less than 2.5 g/dL, determined by 2 analyses 10 weeks apart; bleeding esophageal varices or congestive gastropathy; chronic hepatic encephalopathy; chronic ascites

--Prior/Concurrent Therapy-- No concurrent drugs associated with chronic liver disease

--Patient Characteristics--

Hematopoietic: WBC at least 2500 Platelets at least 100,000 (unless due to hypersplenism); Hematocrit at least 30%

Renal: No renal disease that could cause liver dysfunction

Other: No history of alcohol abuse; No other medical illness that might cause liver dysfunction, e.g., severe cardiac failure; No pregnant women
18F-AV-1451 Autopsy Study

This study is designed to test the relationship between ante-mortem flortaucipir Positron Emission Tomography (PET) imaging and tau neurofibrillary pathology associated with Alzheimer's disease (AD), as measured at autopsy.


Eligibility Criteria:
Inclusion Criteria:

* Have a projected life expectancy of ≤ 6 months
* Can tolerate a 20 minute PET scan
* Give informed consent or have a legally authorized representative to consent for study procedures and brain donation consistent with the legal requirements of the State in which they die

Exclusion Criteria:

* Aggressively being treated with life sustaining measures
* Known to have a structural brain lesion that would interfere either with PET imaging or pathological assessment
* Clinically significant infectious disease
* Currently receiving any investigational medications except with permission from the study sponsor
* Participated in an experimental study with an amyloid or tau targeting agent
* Suspected encephalopathy due to alcoholism or end-stage liver disease
* Females of childbearing potential
* History of risk factors for Torsades de Pointes or are currently taking medication known to cause QT prolongation
Immune Boost In Non-Small Cell Lung Cancer

Insufficient migration and activation of tumour specific effector T cells seems to be the one important reason for inadequate host anti-tumour immune response. Ionizing radiation can induce a variety of immune responses. The goal of this randomized trial is to assess if a preoperative single fraction low dose radiation is able to improve anti-tumour immune response in operable early stage lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven clinical stage I to IIA pulmonary adenocarcinoma
* Lung tumor is felt to be curatively resectable by the treating physicians
* Sufficient pulmonary function for lobectomy according to current guidelines
* The patient is free of distant metastases as confirmed by contrast-enhanced chest and upper abdomen CT-scan and by contrast-enhanced CT or MRI of the brain
* Age over 50years at the time of consent due to federal radiation protection law
* In female patients of childbearing potential there must be a negative pregnancy test
* Eastern Cooperative Oncology Group performance status of 0,1, 2 or 3 at the time of randomization
* Patients who the investigator believes can and will comply with the requirements of this protocol
* Written informed consent according to good clinical practise and national/regional regulations

Exclusion Criteria:

* The patient shows clinical signs of pneumonia
* The patient receives immunosuppressive drugs (alkylating agents, antimetabolites, methotrexate, azathioprine, mercaptopurine, cytotoxic antibodies, ciclosporin, tacrolimus, sirolimus, interferon, mycophenolate, small biological agents)
* The patient has been diagnosed with a potential immune mediated disease
* Elevated blood leukocyte count or erythrocyte sedimentation rate
* Pregnancy
* The patient has received any cancer specific treatment, including radiotherapy, immunotherapy, hormonal therapy or chemotherapy
* The patient is diagnosed with a concomitant malignancy and/or has a history of malignancy within the past five years or has had a malignancy that has been in complete remission for less than 5 years
* The patient needs chronic long term oxygen therapy
* The patient has undergone splenectomy
* The patient is known to be HIV positive
* The patient has an uncontrolled bleeding disorder
Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors

The purpose of this research study is to test the safety of chloroquine in combination with carboplatin and gemcitabine and see what effects (good and bad) it has on advanced solid tumors.

Also, the research study will be increasing the dose of chloroquine to find the highest dose of chloroquine that can be given in combination with carboplatin and gemcitabine without causing severe side effects.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of a malignancy that is metastatic or unresectable and for which either standard curative measures do not exist or are no longer effective and carboplatin/gemcitabine is considered a reasonable treatment option whether first line or acceptable and approved combination therapy.
* Age \>18 years of age.
* Performance status less than or equal 2 (Karnofsky \>60%)
* Life expectancy of greater than 3 months.
* Adequate labs
* Measurable disease

Exclusion Criteria:

* Current treatment with any other investigational agents.
* Patients with untreated brain metastases
* History of allergic reaction attributed to compounds of similar chemical or biologic composition to chloroquine or other agents used in study.
Promacta Pregnancy Registry

Since Idiopathic Thrombocytopenic Purpura (ITP) affects women who are of reproductive capacity and taking into account the lack of data concerning Eltrombopag (Promacta) use during pregnancy, the Eltrombopag (Promacta) Registry will be an essential component of the ongoing risk management for Eltrombopag (Promacta). The Registry will detect and record the events (live births, spontaneous abortions, stillbirths, elective terminations, therapeutic terminations, any serious pregnancy outcome, major and minor congenital anomalies, outcomes including preterm, small for gestation age, or intrauterine growth restriction adverse adverse effects on the following: immune system development, platelet number and function, neoplasm formation, bone marrow reticulin formation, thrombotic events) in the mother and/or the neonate/infant. The adverse events in the infant will be assessed through at least the first year of life. The Pregnancy Registry will compare the pregnancy and fetal outcomes of women exposed to eltrombopag Tablets during pregnancy to an unexposed control population. This study will be a prospective observational, exposure follow-up study.

The outcomes of pregnancy are: live births, spontaneous abortions, stillbirths, elective terminations, therapeutic terminations, any serious pregnancy outcome, major and minor congenital anomalies, outcomes including preterm, small for gestation age, or intrauterine growth restriction adverse effects on the following: immune system development, platelet number and function, neoplasm formation, bone marrow reticulin formation, thrombotic events in the mother and/or the neonate/infant.

Eligibility Criteria:
Inclusion Criteria:

Documentation that Eltrombopag is being taken during pregnancy. Timing of the prenatal exposure to Eltrombopag (i.e. best estimation of which trimester in pregnancy that there was exposure to Eltrombopag for stratification and reporting purposes). Sufficient information to determine whether the pregnancy is being prospectively or retrospectively registered. Whether the outcome of pregnancy was known at the time of the report. Source of the report (i.e. health care professional, patient). Full provider contact information to allow for follow-up (name, address, etc.)

Exclusion Criteria: None
Ruptured Aneurysms Treated With Hydrogel Coils

To determine safety and occlusion rates when second-generation hydrogel coils are used in the treatment of ruptured intracranial aneurysms.

RAGE is a prospective, non-randomized, multicenter, post-market study. The RAGE study is designed to determine the safety and occlusion rates of hydrogel coils in the ruptured aneurysm study population. Secondary objectives include determining clinical outcomes, packing density, occlusion stability, rates of recurrence, rebleed, retreatment, and adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is ≥ 18 and ≤ 80 years of age.
2. Patient has a previously untreated, ruptured saccular intracranial aneurysm 2 - 15 mm in diameter for which the clinical decision to treat with hydrogel coil embolization has been made independent of the decision to participate in the study described in this protocol.
3. Patient has a baseline Hunt and Hess Score of I, II, or III.
4. Patient or patient's legally authorized representative has provided written informed consent.
5. Patient must be considered by the treating physician to be available for and able to complete all followup visits.
6. Patient has not been previously entered into this study.

Exclusion Criteria:

1. Inability to obtain written informed consent.
2. Patient is \< 18 or \> 80 years of age.
3. Patient has a baseline Hunt and Hess score of IV or V.
4. Target aneurysm is dissecting, fusiform, mycotic, blister-like, tumoral, or AVM-related.
5. Target aneurysm maximum diameter is \> 15 mm or \< 2 mm.
6. Target aneurysm was previously treated via clipping or coiling.
7. Target aneurysm is deemed by the treating physician to be unsuitable for coiling or unlikely to be successfully treated by endovascular techniques.
8. Target aneurysm has not been confidently determined by the treating physician to be the source of SAH.
9. Planned use of a flow diverter or intrasaccular device as a component of the target aneurysm treatment plan.
10. Intended use of a coil-assist stent as a component of the target aneurysm treatment plan, unless use of a stent is 1) planned as a subsequent stage of a staged coiling procedure or 2) used for bailout purposes.
11. Patient has a known, untreatable hypersensitivity to contrast dye, iodine, hydrogel, or any other component of the treatment device.
12. Patient has a contraindication to heparin or aspirin.
13. Patient has vascular anatomy/tortuosity preventing access to the target aneurysm.
14. Patient is unable to undergo DSA or DSA is determined unsuitable or outside standard of care by the treating physician.
15. Patient has a serious or life-threatening comorbidity that could confound study results.
16. Patient is at high risk of noncompliance due to a history of substance abuse, psychosocial issues, etc.
17. Patient is unable to complete scheduled followup assessments due to comorbidities, geographical limitations, or a life expectancy of less than 18 months.
18. Patient is pregnant, breastfeeding, or plans to become pregnant prior to completion of followup.
19. Patient is enrolled in another device or drug study in which participation could confound study results.
Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Cardiac Surgery

The primary endpoint of this study is the completion time of hemostasis treatment when administered Fresh frozen plasma (FFP) and frozen powder coagulation factor concentrate (PCC) in goal-directed bleeding management for cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing cardiac surgery

Exclusion Criteria:

* thrombocytopenia
* oral anti-coagulant
* anti platelet agents
Sleep Self-Regulation Using Mental Imagery

This randomised controlled trial assessed the efficacy of four mental imagery techniques for improving sleep and its related behaviour: (1) imagery focused on reducing arousal levels; (2) imagery incorporating implementation intentions (a strategy designed to link specified behaviour with the anticipated context) for sleep-related behaviour; (3) a combination of imagery using arousal reduction and implementation intention strategies; or (4) a condition where participants were asked to imagine their typical post work activities.

Sleep deprivation is a significant health issue in the modern workplace. We conducted a randomized controlled trial to test the efficacy of techniques involving mental imagery promoting relaxation (arousal reduction; AR) and simulation of the appropriate sleep behavior in the likely environments (implementation intentions; II) in a population of daytime employees

Eligibility Criteria:
Inclusion Criteria:

* ability to read and write in English;
* full-time employment;
* work shifts during daytime hours (i.e., participants were excluded if they worked night shifts either through the organization or through a secondary job) in a position that provided daily access to email;
* a score of five or greater on the Pittsburgh Sleep Quality Inventory (PSQI) which indicates at least moderate difficulties in two or more areas (e.g., sleep quality and daytime dysfunction);

Exclusion Criteria:

* An identifiable biological cause of current sleep deprivation (e.g., sleep apnoea, narcolepsy, restless leg syndrome, periodic limb movement disorder, or pregnancy)
* An identified psychological disorder
* Caring for a child under the age of 5 or have a reason outside of work that caused them to regularly lack sleep.
* Incomplete data (over 50% of daily data missing or missing final follow-up assessment
Great Posture, Great Health

The purpose of this study is to examine the effect of a posture intervention on specific areas of daily function and health: physical, psychological, cognitive, social, and environmental characteristics.

This project promotes community health through postural movement to demonstrate strong physical and mental health benefits. Specifically, Great Posture, Great Health will address two of the top five priorities of general health concerns: 1) obesity and 2) mental health. First, obesity is on the rise although more individuals are meeting or exceeding the current federal physical activity guidelines based on the data provided by the US Department of Health and Human Services (2020). Obesity is a common problem in adults with all socioeconomic status and all races, except Asians. In fact, Asians have low rates of heart disease, asthma, cancer, and a longer life expectancy than other races, potentially due to health behaviors, environment, and stress coping strategies (Acciai et al., 2015). Therefore, we should not overlook the importance of stress coping strategies practiced in Asian countries on obesity. It is becoming more evident that chronic stress (such as elevated cortisol levels) and steroid-based medications are strongly associated with obesity and chronic diseases. It is critical to develop and validate community health strategies to address both priorities. Great Posture, Great Health will introduce one of the most common mind-body postural exercises practiced in Asian countries to a large and diverse population.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be physically capable (defined as easy to moderate physical activities daily at least 60 minutes).
* Participants also must have a normal (18.5-24.9kg/m2) or overweight BMI (25-29.9kg/m2).
* Participants must be able to speak, listen, read, and understand sentences written in English.

Exclusion Criteria:

* More than two risk factors for coronary artery disease (high blood pressure, high blood cholesterol level (LDL), family history (a close relative with heart disease), diabetes mellitus, chronic kidney disease
* History of falls, osteoporosis, osteoarthritis, or orthopedic or neurological conditions (i.e., stroke)
* Medications that cause dizziness or slow movement
* Smoke
* Body mass to height squared ratio greater than 30kg/m2 or less than 18.4kg/m2, blood pressure greater than 140/90 mmHg, or a history of heart conditions.
* Individuals with progressive cognitive, neurologic disorders, cancer treatment, chronic heart failure, or unstable medical conditions