cyrilzakka/clinical-trials huggingface dataset:
A Study of 5-FU Versus MTX+5-FU in Gastric Cancer With Peritoneal Metastasis

To develop effective chemotherapy regimen against gastric cancer with peritoneal metastasis

Peritoneal metastasis is common in advanced gastric cancer and is considered an incurable disease state. Peritoneal metastasis may cause serious complications, such as intestinal obstruction, massive ascites, and hydronephrosis associated with the clinical presentation of abdominal pain and fullness, vomiting, constipation, malnutrition and renal dysfunction.5-FU continuous infusion remains the mainstay for chemotherapy against gastric cancer. On the other, sequential MTX+5-FU was reported to be effective in advanced gastric cancer with peritoneal metastasis in some phase II studies. Therefore, the randomized phase III study of 5-FU versus sequential MTX+5-FU in gastric cancer with peritoneal metastasis was conducted.

Eligibility Criteria:
Inclusion Criteria:

1. histologic confirmation of gastric adenocarcinoma
2. inoperable metastatic disease or recurrent metastatic disease after surgery
3. disease with peritoneal metastasis
4. 20 years or more but less than 75 years
5. performance status 2 or less on the Eastern Cooperative Oncology Group scale
6. no prior treatment for gastric carcinoma except for surgery and adjuvant chemotherapy
7. no prior chemotherapy or radiotherapy for other disease except for gastric cancer
8. adequate bone marrow function, adequate liver function, and adequate renal function
9. no prior transfusion for anemia
10. provision of written informed consent

Exclusion Criteria:

1. Massive pleural effusion
2. brain metastasis with symptoms
3. severe diarrhea
4. other severe medical conditions (infection, diabetes, hypertension, acute myocardial infarction, unstable angina, liver cirrhosis, intestinal pneumonia, pulmonary fibrosis)
5. other active malignancies
Nicotine Pharmacokinetics and Pharmacodynamics, Safety and Tolerability of P3P

This is a single-center, open-label, randomized, crossover study to evaluate the pharmacokinetic (PK) profiles of four P3P variants (differing in nicotine aerosol particle size, nicotine concentration and in the absence or presence of a flavoring system), following a fixed puffing regimen and an ad libitum use period. In addition, pharmacodynamic (PD) effects (subjective effects and related behavioral assessments), as well as human puffing topography, will be evaluated, to provide further insights on product safety, acceptance, and use.

The goal of the proposed study is to evaluate the pharmacokinetic profiles of four P3P variants. Variants with two different nicotine contents (1 mg/product and 2 mg/product), two different nicotine aersol particle sizes and presence/absence of a flavoring system will be tested to identify which one would yield plasma nicotine concentrations as close as possible to those achieved after smoking a single cigarette. All of the subjects will initially use the lowest nicotine content product (P3P 3). Subject will continue the study using the three remaining products (P3P 1, P3P 2 and P3P 4) containing 2 mg nicotine/product in a randomly assigned sequence.

Two product use regimens: fixed puffing and ad libitum use will be applied to provide insight into nicotine absorption. The fixed puffing regimen with consistent use conditions across subjects will be applied in order to minimize variability. The 1 hour ad libitum use period will provide information on nicotine PK and product acceptance when subjects use the P3P according to their own puffing behavior which is closer to a real-world setting.

Safety and tolerability will also be assessed throughout the study.

Eligibility Criteria:
Inclusion criteria:

* Subject has signed the Informed Consent Form (ICF) and is able to understand the information provided in the ICF.
* Subject is between 21 and 65 years old.
* Subject is Caucasian.
* Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the screening period.
* Subject has been smoking at least 10 commercially available cigarettes per day at least for the last 4 weeks prior to Screening Visit. Smoking status will be verified based on a urinary cotinine test (cotinine ≥ 200 ng/mL).
* Subject has been smoking for at least the last 3 years prior to Screening Visit.
* Subject does not plan to quit smoking in the next 2 months after the Screening Visit.

Exclusion criteria:

* Female subject is pregnant or breastfeeding.
* Female subject uses estrogen-containing hormonal contraception or hormone replacement therapy.
ADME Study of [14C]-Ibrexafungerp in Healthy Male Subjects

This is a Phase 1, open-label, single-centre, non-randomised study to evaluate the absorption, distribution, metabolism, and excretion (ADME) of an oral solution of \[14C\]-ibrexafungerp following administration in healthy male subjects.

Each subject will receive a single dose of \[14C\]-ibrexafungerp and will be followed for up to 20 days. During this period total radioactivity will be measured in blood, urine and faeces.

This is a Phase 1, open-label, single-centre, non-randomised study to evaluate the absorption, distribution, metabolism, and excretion (ADME) of an oral solution of \[14C\]-ibrexafungerp following administration in healthy male subjects.

Each subject will receive a single dose of \[14C\]-ibrexafungerp and will be followed for up to 20 days. During this period total radioactivity will be measured in blood, urine and faeces.

All subjects will undergo preliminary screening procedures for the study at the screening visit. Subjects will be admitted to the clinical unit on the evening prior to dosing (Day -1). A single oral dose containing \[14C\]-ibrexafungerp oral solution will be administered to subjects. Individual subjects will be released from the clinical unit following study-related procedures on Days 8 to 20 according to their % of radioactivity collected in relation to the dose administered.

Eligibility Criteria:
Key Inclusion Criteria:

* Healthy males
* Age 30 to 65 years of age at the time of signing informed consent
* Must be willing and able to participate in the whole study
* Must provide written informed consent
* Must agree to adhere to the contraception requirements

Key Exclusion Criteria:

* Subjects who have received any investigational drug in a clinical research study within the 90 days prior to Day 1
* Current smokers
* Recent radiation exposure
* Subjects who have been enrolled in a 14C ADME study in the last 12 months
* An acute or chronic disease determined by the investigator to be clinically significant
* Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis at screening as judged by the investigator
* Evidence of renal impairment at screening
* History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder
Targeted Vs Generic Print Materials on Physical Activity and Quality of Life in Young Adult Cancer Survivors

Young adult cancer survivors (YACS) are an understudied group in cancer survivorship research that have unique psychosocial, medical and survivorship issues. Physical activity (PA) has important effects on health-related outcomes in middle-aged and older cancer survivors and preliminary research suggests similar benefits in YACS (18-39 years). Unfortunately, only about half of YACS report meeting public health PA guidelines and there are no interventions or resources available to help YACS increase their PA. The purpose of this study is to test a physical activity guidebook that was developed for YACS based on the theory of planned behavior (TPB). The PA guidebook will be evaluated in a randomized controlled trial. Specifically, 300 YACS will be randomly assigned to (a) Canada's PA guidelines for adults or (b) the YACS PA guidebook. YACS will complete assessments of PA, quality of life, and psychosocial variables at baseline (prior to randomization), 1 month, and 3 months. The primary endpoint in the trial will be change in self-reported PA minutes from baseline to 3 months. Secondary endpoints will include changes in TPB constructs and quality of life. It is hypothesized that the group receiving the YACS PA guidebook (TARG) will report a greater increase in PA minutes compared to the group receiving Canada's PA guidelines (CPAG).


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with cancer in Alberta, Canada
* Still living in Alberta, Canada
* Read English

Exclusion Criteria:

-
A Study to Investigate the Effect of Mirabegron (YM178) on Subjects With Mild or Moderate Hepatic Impairment Compared to Healthy Subjects

The study aims to investigate and compare the effect of Mirabegron (YM178) on subjects with mild and moderate hepatic impairment compared to healthy subjects.

Healthy subjects and subjects with mild and moderate hepatic impairment are admitted on Day 1. Subjects receive a single oral dose of Mirabegron in the morning of Day 1 and will remain in the unit till Day 5 with outpatient visits on Days 6 and 7 for healthy subjects and Days 6, 7, 9 and 11 for subjects with hepatic impairment. Blood sampling for PK assessment will be up to 144 hrs post dose for healthy subjects and up to 240 hrs post dose for subjects with hepatic impairment. An additional blood sample was obtained for all subjects 4 hrs post dose for protein binding.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index more than or equal to 18.0 and less than 32.0 kg/m2 (men and women)
* Subject is genotyped as an extensive metabolizer for CYP2D6
* For subjects with mild/moderate hepatic impairment: Hepatic dysfunction scored as mild impairment ((between 5-6 in the Child-Pugh's classification) and moderate impairment (between 7-9 in the Child-Pugh's classification)
* Healthy subject with normal hepatic function

Exclusion Criteria:

* Known or suspected hypersensitivity to mirabegron or any components of the formulations used
* A marked prolongation at screening of QT/QTC interval demonstrated by a mean QTcF interval \>450 ms for male subjects and a mean QTcF interval \>470 ms for female subjects (based on 3 ECGs)
* Abnormal pulse rate and/or blood pressure measurements at the pre-study visit taken in triplicate by means of an automatic device, after subject has been resting in supine position for 5 min: •Pulse rate \<40 or \>90 bpm; Mean systolic blood pressure \<90 or \>160 mmHg; Mean diastolic blood pressure \<40 or \>95 mmHg
* Healthy subjects: use of any prescribed or OTC drugs (except paracetamol, with a maximum of 3g/day) in the 2 weeks prior to admission to the clinical unit
VAC-Stent Registry

This registry is intended to collect data on quality assurance and use of the VAC-Stent® and thus verify the suitability of the VAC-Stent® for sealing leakages in the oesophagus or colon. Furthermore, the safety and efficacy of the VAC-Stent® shall be proven.

For this registry, quality assurance data will be prospectively collected from all patients who receive the VAC-Stent®. The VAC-Stent® combines a vacuum sponge, which lies intraluminal and conditions the wound, with a covered stent, which seals the sponge from the lumen and thus ensures passage. Due to its design, the new medical device VAC-Stent® offers a solution for the most important problems of the covered stent, the stent migration and the lack of drainage function, as well as for those of the endoluminal vacuum sponge, the blockage of the gastrointestinal lumen and the difficult application. The VAC-Stent® is the technical advancement for all indications of the covered stent and for the indication of the endoluminal vacuum sponge, so that a very good effectiveness with reduced complications can be expected for these clinical situations.

The VAC-Stent® therefore offers the prospect of an innovative further development in the endoscopic treatment of leaks in the gastrointestinal tract, without any new and unknown risks being associated with it.

The primary aim of this registry is to collect data on the quality assurance and application of the VAC-Stent® and thus to evaluate the suitability of the VAC-Stent® for sealing leaks in the oesophagus or colon. In addition, the safety and efficacy of the VAC-Stent® will be demonstrated.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* treatment with the VAC-Stent®

Exclusion Criteria:

- accommodation in an institution under court or administrative order
A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (MIUC)

The main purpose of the study is to evaluate the efficacy of adjuvant treatment with autogene cevumeran plus nivolumab compared with nivolumab in participants with high risk MIUC.

In this study participants will be enrolled in a safety run-in phase to receive autogene cevumeran + nivolumab. This phase will be conducted to monitor and ensure the safety of study participants. After all participants in the safety run-in have been enrolled to receive autogene cevumeran + nivolumab, further participants will be randomization in either autogene cevumeran + nivolumab or the saline + nivolumab arm.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed muscle-invasive UC (also termed TCC) of the bladder or upper urinary tract
* TNM classification (UICC/AJCC 7th edition) at pathological examination of surgical resection specimen of (y)pT3-4 or (y)pN+ and M0
* Surgical resection of MIUC of the bladder or upper tract
* Participants who have not received prior neoadjuvant cisplatin chemotherapy (NAC) must be ineligible to receive adjuvant cisplatin therapy due to patient refusal, cisplatin ineligibility or investigator decision
* Tumor tissue must be provided for biomarker analysis
* Absence of residual disease and absence of metastasis, as confirmed by a negative baseline Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan of the pelvis, abdomen, and chest no more than 28 days prior to randomization.
* Full recovery from cystectomy or nephroureterectomy within 120 days following surgery
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Negative HIV test at screening
* No evidence of active hepatitis B, defined as having a negative hepatitis B surface antigen (HbsAg) test at screening
* Negative hepatitis C virus (HCV) antibody test at screening, or a positive HCV antibody test followed by a negative HCV RNA test at screening

Exclusion Criteria:

* Partial cystectomy in the setting of bladder cancer primary tumor or partial nephroureterectomy in the setting of renal pelvis primary tumor
* Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
* Any prior neoadjuvant immunotherapy
* Adjuvant chemotherapy or radiation therapy for UC following surgical resection
* Malignancies other than UC within 5 years prior to randomization
* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
WAVE~Ripples for Change: Obesity Prevention in Active Youth

Intervention targets youth ages 14 - 19 participating in soccer teams. The intervention group will be given face to face nutrition lessons and have access to an online immersive learning environment. The comparison group will not. The project will test if the immersive learning environment is effective in preventing unhealthy weight gain.

Active youth are just as likely to develop poor dietary habits that can contribute to obesity later in life, after high school sports has ended. However, youth in sports may provide a key "window of opportunity" to teach them about eating health foods if that information is tied to sport performance. This project will test to see if that is true.

The virtual world is an idea medium for learning for this project. The project will test whether it indeed can result in behavior change more effectively than just more traditional face to face learning.

Eligibility Criteria:
Inclusion Criteria:

* youth ages 14 - 19 at baseline
* enrolled in a high school soccer program
* living with a parent/caregiver in Oregon
* without medical condition that hinders them from consuming normal healthy diets
* has assess to the internet during the 2-year study
* proficient in English

Exclusion Criteria:

* non-English speakers (youth)
* prisoners
Massage of the Low Back Muscles Assessed With Ultrasound Scanning

The aim of the study is to use diagnostic ultrasound to compare the thickness of soft tissues in the low back in a group of patients with chronic low back pain treated with massage to a control group of non-treated patients.

It is hypothesized that on average, soft tissue thickness in the lumbar region will change in the group receiving massage compared to the control group.

A specialized form of massage designed to reduce fascial restrictions will be compared to a no-treatment control group based on a change in thickness of the lumbodorsal fascia as determined by ultrasound imaging.

Eligibility Criteria:
Inclusion Criteria:

* History of chronic low back pain far at least 3 months
* Able to read and write English
* Between 18-64 years of age

Exclusion Criteria:

* Prior lumbar surgery
* Infected or broken skin over the lumbodorsal fascia
* Major structural spinal deformity
* Specific cause of low back pain, such as tumor, infection, fracture
* Bleeding disorders or use of anticoagulant medications
* Pregnancy
* Litigation for low back pain
* Systemic infection
Vitamin D and Painful Diabetic Neuropathy

The main objective of this study is to evaluate the effect of vitamin D3 on diabetic individual with painful neuropathy in a tertiary healthcare.

The people with diabetes (type 1 and type 2) who have a Douleur Neuropathique 4 (DN4) score ≥4 will be considered eligible in this prospective study. Their serum samples will be subjected to pre-and post-biochemical screening of serum 25 (OH) D and HbA1c. The individual having Vitamin D insufficiency and deficiency will be administered a single dose of oral Vitamin D3 (Soft Gel capsule 200,000 IU), and follow-up for post-biochemical screening after 3 months.

Painful diabetic neuropathy (PDN) is the most common diabetic complication in patients who have had diabetes mellitus for a long time. Diabetic peripheral neuropathy is the common cause of neuropathy globally. About 50-60% of individuals with long-term diabetes develop diabetic neuropathy. Several recent observational studies in diabetic individuals have provided a correlation between vitamin D insufficiency and diabetes. Despite the fact that the pathogenesis of diabetic neuropathy is complex, recent investigations revealed that deficiency of vitamin D is an important factor in the development of diabetic neuropathy. Also, vitamin D supplementation was found to be effective in treating neuropathic pain and preventing neuronal degeneration.

Aims and Objectives:

The assessment of the effect of single-dose, oral vitamin D in patients with painful diabetic neuropathy.

Materials and Methods:

Study Drug: Oral cholecalciferol (Vitamin D3 capsule 200,000 IU).

A single oral dose of 200000 IU vitamin D will be administered in people with diabetic neuropathy, and the effect will be observed after 3 months.

* Sample size = 216 type 1 and 2 diabetic subjects
* Recruitment time = 4 months
* Treatment duration = 3 months

Ethical Approval:

The ethical approval for this study will be taken from the Institutional Review Board (IRB) of Baqai Institute of Diabetology and Endocrinology (BIDE)

Study Area and Duration:

This study is going to be conducted from October 2021 to March 2022 in the outpatient department (OPD) of BIDE.

Data Analysis and Statistics:

The primary analysis will compare the change from baseline. Comparisons within each treatment group across time will also be considered. The analysis will be performed with the Statistical Package for the Social Sciences (SPSS).

Assessment during the Treatment Period:

* Change from baseline in DN4
* Change from baseline in serum 25 (OH) D,
* Change from baseline in HbA1c

Eligibility Criteria:
Inclusion Criteria:

* Insulin dependent diabetes
* Insulin independent diabetes
* Age range between 25 to 80 years
* Glycated hemoglobin (HbA1c) level must be ≥ 6.5%
* Apparently no symptoms of Vitamin D Deficiency

Exclusion Criteria:

* History of hyperparathyroidism
* Pregnant women
* Lactating mothers
* History for rickets and osteomalacia
* On Vitamin D supplementation
* On Multivitamin
* On anti-epileptics
* On steroids
* On bisphosphonates
* On oral contraceptives
* Subjects who refuse to participate in the study
The Patency Period of the New Plastic Anti-reflux Biliary Stent

The aim of this study is to determine the average patency period of the new anti-reflux biliary stent on patients with malignant bile duct strictures and to determine if this stent remains patent for a longer period of time comparing with the ordinary plastic Tannenbaum biliary stent.

Bile duct related cancer is a condition quite commonly seen among Asians. Predisposing conditions for primary bile duct cancer include recurrent infections and autoimmune diseases such as recurrent pyogenic cholangitis (RPC) and primary sclerosing cholangitis (PSC) as well as congenital problem such as choledochal cyst. Peri-ampullary tumour, pancreatic tumour and metastatic tumours with bile duct compression are other causes of bile duct obstruction. As many of these tumours are discovered at a late stage, curative treatment is usually not feasible. Palliative endoscopic stenting of the obstructed biliary system remains the treatment of choice for the majority.

The main problem with endoscopic stenting of the biliary system is the short stent patency period. There are some reports on modifications to plastic biliary stenting method in recent years including changes in stent designs, use of a different material or coating, administrating prophylactic antibiotics and the use of special drugs. All these have failed to show any conclusive effect on the stent patency period.

A preliminary study has demonstrated some promising results in the use of a stent with an anti-reflux property very similar to the stents the investigators are using in this study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years old
* Patients who have cholangiographic evidence (on ERCP) consistent with a malignant extrahepatic biliary stricture (below bifurcation of the common hepatic duct) who require plastic stenting
* Patients with peri-ampullary tumours, pancreatic tumours, gall bladder cancer and metastatic tumours with suspected extrinsic bile duct compression
* Patients with stent or nasobiliary drain in-situ without previous sphincterotomy will qualify for the study if they satisfy the above inclusion criteria.

Exclusion Criteria:

* Patients fit for surgery.
* Patients who have dominant biliary strictures involving the hilum or more proximal biliary segments.
* Previous sphincterotomy.
* Other medical conditions that will result in a life expectancy of less then 3 months (ASA class \>4)
* Pregnancy