cyrilzakka/clinical-trials huggingface dataset:
Bioavailability and Food Effect Study of TKI258 (CSF Capsule vs. FMI Tablet) in Adult Patients With Advanced Solid Tumors

This study will evaluate the relative bioavailability of 2 oral formulations of TKI258, and the effect of food on the bioavailability of TKI258, in adult patients with advanced solid tumor.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an advanced solid tumor which has progressed despite standard therapy, or for which no standard therapy exists
* World Health Organization (WHO) performance status ≤ 2
* Patient must meet protocol-specified laboratory values

Exclusion Criteria:

* Patients with brain cancer
* Patients who have concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study
* Patients who have not recovered from previous anti-cancer therapies
* Female patients who are pregnant, breast feeding, or not willing to use an effective method of birth control

Other protocol-defined inclusion/exclusion criteria may apply
Study of PEP02 as a Second Line Therapy for Metastatic Pancreatic Cancer

The purpose of this study is to see the effect of PEP02 in the treatment of metastatic pancreatic cancer.

Gemcitabine monotherapy or a gemcitabine-based combination regimen is the standard first line therapy for advanced pancreatic cancer. After disease progression, there is no standard treatment available. In animal studies and a previous phase I trial, PEP02 has shown anti-tumor activity and preliminary efficacy in pancreatic cancer. In addition, a phase II study of free-form irinotecan single agent has already shown encouraging activity as second-line treatment for patients with advanced pancreatic cancer refractory to gemcitabine. The liposome formulation of PEP02 theoretically has therapeutic advantages over free-form irinotecan, such as site-specific delivery and extended release of drug. Hence PEP02 may be able to provide better efficacy than free-form irinotecan.

The primary purpose of this phase II study is to evaluate the activity of PEP02 as a second-line therapy in patients with metastatic pancreatic cancer failed to gemcitabine treatment. The primary goal is to measure the 3-month survival rate. An optimal Simon's 2-stage design will be used for this exploratory phase II study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
* Metastatic disease
* Documented disease progression after treatment with 1 line of prior gemcitabine-based regimen
* Karnofsky performance status equal or more than 70

Exclusion Criteria:

* With active CNS metastases
* With clinically significant gastrointestinal disorder (e.g., bleeding, inflammation, occlusion, or diarrhea \> grade 1)
* Major surgery or radiotherapy within 4 weeks
* Prior participation in any investigational drug study within 4 weeks
* With prior irinotecan treatment
Incidence of Postoperative Ketosis and Metabolic Acidosis

The aim of this study is to define the incidence and nature of acidosis after major surgery using Figge's equations to directly measure acidosis. This study will also aim to compare the ability of indirect measures (base deficit, anion gap,corrected anion gap and lactate) to identify the presence of tissue acids in this population. The incidence of postoperative ketoacidosis as a contributor to tissue acidosis will be assessed through the use of point of care urinalysis.

Metabolic acidosis is a frequent occurrence following major surgery. Monitoring acid base disturbances and in particular diagnosing the aetiology of the acidosis are important parts of assessing a patient's cardiovascular status following surgery. The presence of a metabolic acidosis is frequently attributed to anaerobic metabolism leading to the generation of lactic acid due to hypovolaemia and poor tissue perfusion. This commonly results in clinicians treating postoperative patients with a metabolic acidosis by administering intravenous fluids containing 0.9% saline or Hartmann's solution (compound sodium lactate). If the cause of the metabolic acidosis is not hypovolaemia, treatment with intravenous fluids may actually exacerbate the acidosis by causing hyperchloraemia. An often overlooked cause of metabolic acidosis after surgery is starvation leading to ketoacidosis. All patients are starved for a minimum of six hours prior to general anaesthesia due to the potential risk of aspiration of gastric contents into the bronchial tree. Many patients are in fact fasted for much longer periods than this. There is, however, little data describing the incidence of ketoacidosis following surgery. In addition, there may be other causes of acidosis after surgery which often overlooked but can be determined using equations and mathematical models. The aim of this study is to define the incidence and nature of acidosis after major cancer surgery using using equations to directly determine acids. This study will also aim to compare the ability of commonly used indirect measures (base deficit, anion gap, corrected anion gap and lactate) to identify the presence of tissue acids in this population. The incidence of postoperative ketoacidosis as a contributor to tissue acidosis will be assessed through the use of point of care urinalysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone major cancer surgery
* Patients who have an arterial line in place
* Patients who have a urinary catheter in place
* Patients who will be admitted to intensive care following surgery
* Adults \>18 years
* Adults who are capable of reading and understanding English

Exclusion Criteria:

* Patient refusal
* Patients without an arterial line or urinary catheter in place
* Patients receiving glucose / sliding scale insulin for management of diabetes mellitus
Bone Marrow Mesenchymal Stem Cells Transfer in Patients With ST-segment Elevation Myocardial Infarction

To investigate the effect and safety of intracoronary autologous bone morrow mesenchymal stem cells (BM-MSCs) transplantation in patients with ST-segment elevation myocardial infarction（ STEMI） .

To investigate the safety of intra-coronary injection of autologous bone marrow mesenchymal stem cells (BM-MSCs) in patients with ST-segment elevation myocardial infarction and its effect on cardiac function and viable myocardium. We plan to include approximately 40 patients with ST-segment elevation myocardial infarction as a research object, and conduct a randomized, single-blind, parallel-controlled multi-center clinical trial. The patients were randomly divided into a BM-MSCs group and a control group, and were given the best drug treatment and percutaneous coronary intervention (PCI). The primary study endpoint was the change in myocardial metabolic activity 6 months after autologous BM-MSCs transplantation and the change in left ventricular ejection fraction (LVEF) at 12 months; The incidence of adverse events. The above indexes were evaluated by cardiac color echocardiography and single photon emission computed tomography (SPECT).

Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years old;
* Diagnosed acute ST-elevation myocardial infarction (STEMI)
* STEMI onset \<1 month
* Successful vascular remodeling, blood flow of infarct-related blood vessels recovered to TIMI level 3
* All patients included in the study signed an informed consent form and promised to complete all follow-up plans

Exclusion Criteria:

* Refractory persistent ventricular tachycardia
* High cardiac block and no pacemaker control
* Liver or renal dysfunction (ALT\>80U/ L, Cr\> 440mmol / L)
* Bleeding disorders, malignant tumors
* Autoimmune disease or any serious fatal disease
* Contraindications for coronary intervention
* Combined with other heart disease: congenital heart Disease (ventricular deficiency, atrial deficient, patent ductus arteriosus and other congenital alformations),primary valvular disease, active myocarditis, pulmonary heart disease,hyperthyroidism, mucous edema heart disease and so on
* Mental illness, no self-awareness, and no precise expression and cooperation
The Total Neoadjuvant Therapy for Soft Tissue Sarcoma of the Extremities

For localized soft tissue sarcomas (STS) of the extremities, limb-sparing or conservative surgery with perioperative radiotherapy (RT) is the standard of care. However, several challenges persist. Notably, there are exceedingly high rates of distant metastatic recurrence even after surgical resection and RT, and conventional fractionated radiotherapy has a prolonged duration (5-6 weeks). With advancements in RT technology, the gradual expansion of hypofractionated radiotherapy regimens enables significantly shorter treatment durations. Promising recent reports on 1-week hypofractionated RT regimens, such as the 5X5 Gy RT regimens, have demonstrated reasonable local control and acceptable toxicity in resectable STS.Addressing the challenge of distant metastasis, previous studies have indicated that AI regimens are expected to eliminate micrometastases and improve survival in patients with STS at a high risk of distant relapse. Therefore, the goal of this clinical trial is to investigate whether hypofractionated RT combined with a sequential chemotherapy（AI regimens）can enhance short-term treatment efficacy for extremity STS patients without compromising local control rates and increasing related toxicities


Eligibility Criteria:
Inclusion Criteria:

1. Primary soft tissue sarcoma of the extremities, with one of the following characteristics: high grade, ≥5cm or deep tumor, the need for neoadjuvant radiotherapy was determined after multidisciplinary consultation.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
3. Age 18-75 years old.
4. Histologic diagnosis of soft tissue sarcoma.
5. Can tolerate radiotherapy and AI regimen treatment.
6. The function of major organs is normal.

Exclusion Criteria:

1. There were no patients with gross tumors after unplanned mass resection in another hospital.
2. Patients with other comorbidities cannot use AI chemotherapy: drug allergy, active bleeding, ulcers, intestinal perforation, intestinal obstruction, uncontrollable hypertension, grade III-IV cardiac insufficiency (NYHA standards), severe liver and renal insufficiency ( Level IV) etc.
3. New malignant tumors within 5 years (except cervical carcinoma in situ or early cutaneous basal cell carcinoma).
4. Pathological types: nonpleomorphic rhabdomyosarcoma, Ewing sarcoma.
5. Soft tissue sarcoma curable by simple expansion.
6. Previous history of radiotherapy to the same site.
7. Combined with distant metastasis (M1) or lymph node metastasis (N1).
8. Have other severe medical comorbidities that preclude surgery or participation in the study.
9. Previous exposure to chemotherapy.
Effect of Functional Massage in Neuromuscular Response.

The study compares the effects of two types of massage: a conventional massage and a functional massage, in the neuromuscular response of the gastrocnemious muscles.


Eligibility Criteria:
Exclusion Criteria:

* Muscle injury in the last two months
* To not understand the study orders
* Suffer a musculoskeletal disorder that doesn't allow the subject to do the study protocol
Anti-hypertensive Effect of Mycelia of Antrodia Cinnamomea

This the first report undertaken to assess the effect of supplementation with oral gamma-aminobutyric acid (GABA), adenosine and antrosterol-containing AC mycelia on blood pressure among people with mild hypertension. Overall, AC mycelia consumption for 8 weeks could successfully reduce mean diastolic and systolic BP through the suppression of PRA that is linked to downstream suppresion of angiotensin II formation, which further decreases the sympathetic outflow that leads to hypertension. In addition to blood pressure lowering properties, AC mycelia also has beneficial effect in reducing oxidative stress, significantly. No adverse events were noted, suggesting that AC mycelia deserve its consideration as a candidate for safe alternative treatment to conventional anti-hypertensive medications.

This the first report undertaken to assess the effect of supplementation with oral gamma-aminobutyric acid (GABA), adenosine and antrosterol-containing AC mycelia on blood pressure among people with mild hypertension. Forty-one subjects with systolic blood pressure (SBP) between 130 and 179 mm Hg and/or diastolic blood pressure (DBP) between 85 and 109 mm Hg were randomized to receive either AC mycelia or starch placebo for 8 weeks, and had follow-up observation for an additional 2 weeks. SBP in the subjects given GABA, adenosine and antrosterol-rich AC mycelia significantly decreased compared to those who received the placebo (p\<0.05). DBP also decreased after the intake of AC mycelia. Compared to the placebo, AC mycelia significantly reduced plasma renin activity by a maximum of 25 % and 36 % on week 8. This suppression suggested that AC mycelia is a potent inhibitor of renin, and its bioavailability is sufficient to produce BP reduction after a short term of oral administration. Neither adverse events nor abnormal laboratory findings were noted throughout the study period, suggesting that GABA, adenosine and antrosterol-rich AC mycelia significantly decreased borderline hypertension, which may support its consideration as a safe alternative treatment compared to conventional anti-hypertensive medications.

Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects were untreated hypertensive men or women aged between 20 and 80 years old with SBP between 130 and 179 mmHg and/or DBP between 85 and 109 mmHg as measured in a sitting position

Exclusion Criteria:

* Subjects were excluded if they had a history of major cardiovascular disease, severe liver dysfunction, insulin-dependent diabetes mellitus or stroke. They were also excluded if they routinely consumed alcohol, were pregnant or unable to comprehend study instructions.
Oxytocin, Stress, Craving, Opioid Use Disorder

Although stress has long been linked to substance use, craving and relapse, there are no available medications that target stress-induced substance use disorder (SUD). In particular, with the rise in opioid use, there is still a crucial need for developing effective pharmacological treatments that target and integrate the complexity of this disease. The long term goal of this project is to identify the key neuroendocrine pathways that are responsible for stress-induced craving in individuals with opioid use disorder (OUD) in order to better understand how they can be effectively treated.

The goal of this research is to evaluate whether oxytocin, a hormone with anti-stress properties, dampens the effects of stress and opioid-associated cues on opioid craving and thus may be an effective adjunctive treatment for OUD.

The central hypothesis of this research is that oxytocin will reduce stress-induced opioid craving in patients with OUD treated with buprenorphine/naloxone as opioid replacement therapy (ORT). This hypothesis is based on the model of addiction (Koob, Neuron 2008) in which chronic substance use and stress lead to neurobehavioral counter-adaptations that dysregulate biobehavioral response.

In this double-blind, cross-over, placebo controlled, randomized trial, individuals with OUD (N=20 who are currently receiving treatment with buprenorphine/naloxone or methadone will be randomized to intranasal oxytocin (40 international units, IU) and oxytocin-matched placebo, administered twice/day for 7 days with a minimum of two days between the opposite condition (oxytocin or placebo). On days 5 and 7, and on days 14 and 16, participants will complete two counter-balanced sessions in which they receive yohimbine (32.4 mg) or yohimbine-matched placebo.

Eligibility Criteria:
Inclusion Criteria:

* Male or female (50%), 18 to 70 (inclusive) years of age;
* Currently meets DSM-5 criteria for OUD;
* Currently on a stable dose of buprenorphine/naloxone or methadone for at least 3 months;
* In good health as confirmed by medical history, physical examination and blood work (Liver function within 5x the Upper normal limits (AST/ALT) and renal function within 2x the Lower Normal Limit (bilirubin, creatine clearance).
* Willing to take medication and adhere to the study procedures;- Understand informed consent and questionnaires in English at an 8th grade level;
* Clinical Opiate Withdrawal Scale (COWS) = 0 at study screening and prior laboratory sessions.

Exclusion Criteria:

* Women who are breastfeeding, test positive for pregnancy or are unwilling to use medically-approved birth control;
* Suicide attempts in the last three months;
* Current substance disorder other than marijuana, nicotine and caffeine as assessed by self-report and urine toxicology screen at baseline;
* Current use of medications that may interact with study medications;
* History of hypersensitivity to study medications;
* Clinically significant electrolyte abnormalities, current rhinitis or use of vasoconstricting medications or prostaglandins.
PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells

The purpose of this study is to analyze the safety and feasibility of direct administration intrafemoral mesenchymal stem cells (MSCs) in vitro expanded autologous treatment of patients with femoral osteonecrosis.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years
* Clinical diagnosis and imaging (Rx and NMR) of idiopathic osteonecrosis of the femoral head
* Stadiums \<IIIC ARCO ranking

Exclusion Criteria:

* Those on investigator judgment not in a good position to tolerate the procedure.
* Clinical criteria and anesthetics that contraindicate surgery (eg ASA IV-V)
* Serious illness uncontrolled
* Pregnant women
* Patients with HIV infection +
* Acute infection (in the previous 15 days) or chronic (other than HIV)
* Previous treatments of osteonecrosis
* Active or previous neoplastic disease (last 5 years) except for patients undergoing allogeneic haematopoietic progenitors who are in complete remission after 2 years after transplantation.
* Lack of informed consent or revocation thereof.
Thigh Muscle Mass and Muscle Wasting in Patients in the Emergency Department

The goal of this observational study is to evaluate whether thigh muscle mass and muscle wasting are associated with mortality in patients who visit the emergency department. The main questions it aims to answer are:

* Is thigh muscle mass associated with mortality in patient who visit the emergency department?
* Does muscle wasting exist during staying in the emergency department?
* Is muscle wasting associated with mortality in patient who visit the emergency department? Participants will be evaluated for serial thigh muscle mass using point-of-care ultrasound at the emergency department.


Eligibility Criteria:
Inclusion Criteria:

* patients who visit the emergency department of Korea University Ansan Hospital during study period
* patients with age within the limits
* patients who are willing to be participate the study with informed consent
* patients who undergo point-of-care ultrasound to evaluate thigh muscle mass

Exclusion Criteria:

* patients with age out of limits
* patients who have deformities on lower leg
* patients who is unable to maintain appropriate position to undergo point-of-care ultrasound
* patients who decline to participate the study
* patients who have 'do-not-resuscitate' order or are not willing to be resuscitated
* patients of whom point-of-care ultrasound on thigh muscle mass was not performed
Factors Associated With Short Withdrawal Time and Polyp Detection Rate During Colonoscopy

Colonoscopy withdrawal times are a critical element in determining quality of colonoscopy; however, few studies have evaluated specific factors that may influence the duration of withdrawal, and specifically short withdrawal times. Other factors affecting polyp detection rate, one element of quality of colonoscopy, also need further study. By collecting data on hundreds of colonoscopies performed by 9 endoscopists, our goal was to identify factors associated with withdrawal time, inappropriately short withdrawal times, and polyp detection rate during colonoscopy.

Background:

Colonoscopy withdrawal times are a critical element in determining quality of colonoscopy; however, few studies have evaluated specific factors that may influence the duration of withdrawal, and specifically short withdrawal times. Other factors affecting polyp detection rate, one element of quality of colonoscopy, also need further study.

Objective:

To identify factors associated with withdrawal time, inappropriately short withdrawal times, and polyp detection rate during colonoscopy.

Design:

Data were prospectively collected (05/08-06/09) on 802 colonoscopies conducted by 9 blinded endoscopists, including patient age and sex, indication, colonoscope insertion and withdrawal time, biopsies performed, number/size of polyps and method of resection, bowel preparation quality, time of day, day of week, endoscopist, position of the procedure within the endoscopist's slate, and call status of the endoscopist.

Setting:

This study was conducted at a single tertiary care hospital, St. Paul's Hospital, in Vancouver, British Columbia.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients undergoing colonoscopy at St. Paul's Hospital in Vancouver, BC.

Exclusion Criteria:

* Exclusion criteria were prior colon resection and repeat colonoscopy for the purpose of endoscopic therapy for known lesions.
Effects of Human Papillomavirus Diagnosis on Relationships of Patients With Head and Neck Cancer

This trial studies the effects of human papillomavirus diagnosis on the relationships of patients with head and neck cancer. Determining the effects of human papillomavirus diagnosis on relationships may determine whether human papillomavirus-positive patients and their partners are more likely to experience decline in relationship intimacy after diagnosis than human papillomavirus-negative patients and their partners. This may help researchers provide valuable insight into the degree to which a diagnosis of human papillomavirus affects patient relationships over and above the effects of a cancer diagnosis and address the need for additional patient counseling or education following diagnosis.

PRIMARY OBJECTIVES:

I. To explore the agreement between patients' perceived intimacy level and their partners' perceived intimacy level at different time points in the course of their head and neck cancer (HNC) treatment.

II. To compare any changes in the patients' perceived intimacy scores between human papillomavirus (HPV)-positive and HPV-negative HNC patients at different time points in the course of their HNC treatment.

EXPLORATORY OBJECTIVE:

I. Identify areas of concern or misinformation among patients and partners where further patient counseling or education may be indicated.

OUTLINE:

Patients and partners complete surveys over 10 minutes prior to surgery and 3-6 months after completion of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Capable of giving informed consent
* Diagnosis of head and neck cancer (previously untreated, any stage) or in a partnered relationship with an individual diagnosed with head and neck cancer
* Tumors positive for HPV
* Tumors negative for HPV
* Treatment plan is intent to cure
* In a partnered relationship
* Willing to answer brief survey prior to treatment and again after completion of treatment
* English Speaking

Exclusion Criteria:

* Prior treatment (surgery, chemotherapy, radiation therapy \[XRT\], or chemoradiotherapy \[CRT\]) for head and neck cancer
* Partners of eligible patients undergoing active cancer treatment
* Not in a partnered relationship
* Non-English speaking