cyrilzakka/clinical-trials huggingface dataset:
Vaccine Therapy in Curative Resected Prostate Cancer Patients

In this study the investigators will include patients with high risk of PSA relapse scheduled to receive curative surgical treatment. This include patients with high Gleason score (9-10) or micrometastatic disease (tumor cells detected in specimens obtained from bone marrow). They are scheduled for regular follow-ups with PSA measurements. We have previously published that some patients with metastatic prostate cancer may respond to DC-vaccination with tumor mRNA, with a decrease in PSA. PSA response is related to immunological response. Patients receiving DC-vaccination may have a reduced risk of PSA relapse or increased time to PSA relapse. Previous experience with different DC-vaccine protocols in our hospital has resulted in only minor side-effects (grade 1-2 fever, rubor, fatigue, local swelling or pain).


Eligibility Criteria:
Inclusion Criteria:

* Radical prostatectomy. Preferably accessible tumor tissue with enough volume and quality for vaccine production (extraction of tumor mRNA).
* Pathological stage pT2 - pT3b and Gleason score 7B-10, pN0, pN+ or pNx.
* Must be ambulatory with an ECOG performance status 0 or 1.
* Tumor cells detected in bone-marrow samples (micrometastatic disease). Patients with Gleason score 9-10 or pT3b Gleason score 8 may also be included with negative bone-marrow aspiration. Bone-marrow aspirates and plasma for microRNA will be obtained before start of surgery.
* Must be at least 18 years of age and less than 75 years.
* PSA \< 0.2 µg/L within 6 weeks after surgery.
* Must have lab values as the following:

ANC ≥ 1.5 x 109/L; Platelets ≥ 100 x 109/L; Hb ≥ 9 g/dL (≥ 5.6 mmol/L); Creatinine ≤ 140 μmol/L (1.6 mg/dL)- if borderline, the creatinine clearance ≥ 40 mL/min; Bilirubin within the upper limit of normal; ASAT and ALAT ≤ 2.5 the upper limit of normal; Albumin levels above lower normal value

* No metastasis on bone scans or MRI, last 3 months before inclusion.
* Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH/GCP, and national/local regulations.

Exclusion Criteria:

* Previous treatment with LHRH (Luteinizing Hormone-Releasing Hormone) agonist.
* Previous anti-androgen treatment (Casodex).
* History of prior malignancy within the last 5 years, with the exception of curatively treated basal cell carcinoma.
* Active infection requiring antibiotic therapy.
* Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.
* Adverse reactions to vaccines such as asthma, anaphylaxis or other serious reactions.
* History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome.
* Positive testing for syphilis (treponema pallidum), HIV, Hepatitis B and C
* Use of systemic glucocorticoids.
* Any reason why, in the opinion of the investigator, the patient should not participate.
Acupuncture for Symptom Control in Hematopoietic Stem Cell Transplantation Patients

This is a prospective randomized controlled trial to obtain preliminary data for the design of a future definitive efficacy study. A randomized controlled trial is needed because comparison to historical data would be biased. The investigators will use sham acupuncture as the control to account for effect from attention from and interaction with the therapist.


Eligibility Criteria:
Inclusion Criteria:

* Age 21 or above (those age below 21 are usually treated in the Pediatric Transplant Service)
* Diagnosis of multiple myeloma
* Scheduled to receive conditioning chemotherapy followed by upfront or salvage autologous peripheral blood hematopoietic stem cell transplantation

Exclusion Criteria:

* Absolute neutrophil count less than 200/microliter
* Platelet count less than 20,000/microliter
* Acupuncture treatment in the preceding 4 weeks prior to Day 1
Study Of Asthma And Genetics In Patients To Be Treated With Fluticasone Propionate/Salmeterol Or Salmeterol Xinafoate

This study may last up to 36-38 weeks. Patients will visit the clinic 11 times. A blood sample will be taken at Visit 1 to look at subjects' genes. Breathing tests will be done during the study. Study medicines and procedures will be provided at no cost. Patients will be treated with VENTOLIN (8 wks), ATROVENT (8 wks), then ADVAIR or SEREVENT (16 wks). ADVAIR and SEREVENT are FDA approved for the treatment of asthma in patients 4 years of age and older.

A Randomized, Parallel Group, Double-Blind, Comparative Trial Assessing Lung Function and Other Measures of Asthma Control in Adults and Adolescents, at least 12 Years of Age, with Persistent Asthma, Who Have Either a B16-Arg/Arg, a B16-Gly/Gly or a B-16 Arg/Gly Genotype and are Treated With Fluticasone Propionate/Salmeterol DISKUS™ Combination Product 100/50mcg or Salmeterol DISKUS 50 mcg BID

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of persistent asthma for 3 months.
* Use of short-acting beta-agonist medication like VENTOLIN.

Exclusion criteria:

* Hospitalization for asthma 6 months before study.
* Other serious diseases like congestive heart failure, uncontrolled hypertension, TB.
* Current use of inhaled or oral corticosteroids.
Optimisation and Performance of Reduced Preparation CT Colography

To ascertain which of four combinations of low residue diet, reduced laxative dose and oral contrast agent is best tolerated by patients and optimally prepares the colon prior ro CT colonography

CT colonography has been shown to be accurate in detection of colorectal neoplasia in enriched patient populations and is generally preferred by patients to conventional endoscopy and barium enema. It is advocated as an acceptable alternative for colorectal cancer screening and is increasingly used in the investigation of symptomatic patients. Ideally, like conventional colonoscopy, CT colonography requires a clean colon, free of residual stool and fluid. There is however good evidence that the arduous bowel purgation regimes required may produce adverse effects such as electrolyte imbalance, and are more detrimental to overall patient experience and compliance than any subsequent investigation. An ability to perform CT colonography with reduced bowel purgation, whilst maintaining acceptable diagnostic accuracy, would undoubtedly make the technique a more attractive proposition both for population screening and investigation of symptomatic patients.

Interest has been generated in the use of orally ingested dilute barium or ionated contrast medium prior ro CT colonography to "label" or "tag" residual fluid or faecal matter reduced laxative. Such oral contrast agents are highly attenuating to X-rays such that labeled residual bowel contents appear white on CT scanning and are readily distinguished from true colonic pathology.

Despite the early promise of a few limited studies, there is no consensus as to the optimum oral contrast type, dose and concentration. Anecdotally barium tends to best label solid residue whereas iodinated contrast best labels fluid, but this assumption has not been proven. Furthermore it is known that iodinated contrast tends to draw fluid into the bowel, producing a wet colon, which may not be suited to CT colonography. However, this indrawing of fluid by iodinated contrast such as gastrograffin produces a mild laxative effect, which may obviate the need for further formal purgation.

The study aims to establish the optimum reduced preparation-tagging regimen, establish patient experience and document diagnostic performance compared to conventional colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are under investigation for suspected colonic neoplasia and over 50 years old:

  1. Symptomatic patients eg. change in bowel habit, rectal bleeding etc.
  2. Polyp surveillance
  3. Strong family history
  4. suspected neoplasia on previous investigation (e.g. barium enema)

Exclusion Criteria:

* patients under 50 patients undergoing surveillance for inflammatory bowel disease (due to poor diagnostic use of CT colonography in this specific patient cohort)
Evaluate the Efficacy and Safety of 'Immuncell-LC' in Patients Undergoing Liver Transplantation

The purpose of this study is to investigate and validate the maximum tolerated dose (MTD) or maximum available dose (MFD), safety and efficacy on patients with hepatocellular carcinoma beyond Milan criteria who undergo liver transplantation.

ILC-IIT-07 is open-label, phase 1/2 clinical trial to confirm safety on patients with hepatocellular carcinoma beyond Milan criteria who undergo liver transplantation. For primary outcome, maximum feasible dose (MFD) or maximum tolerated dose (MTD) will be evaluated.

For secondary outcome, Time to Recurrence(TTR), Recurrence-Free Survival(RFS), Overall Survival(OS) will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are more than 20 and less than 80 years old.
* Patients whose expected life expectancy is at least 16 weeks (4 months).
* Patients who receive liver transplants exceeding the Milan Criteria.
* ECOG Performance Status (ECOG-PS) score is 0-2.
* Patients who satisfy the following conditions of the blood test and kidney, liver function test.

Absolute neutrophil count \> 500x10\^6L Hemoglobin ≥ 7.5 g/dL Platelet count \> 20,000/㎣ Total bilirubin \< 15mg/㎗

•Patients who have agreed to participate in the study voluntarily by signing on informed consent form.

Exclusion Criteria:

* Patients who have received in vitro radiation therapy, systemic chemotherapy within 4 weeks based on sign date of Informed consent form.
* Patients who undergo ABO incompatible Liver Transplantation.
* Patients who had previously administered cell therapy.
* Patients who are confirmed with Acquired Immune Deficiency Syndrome (AIDS).
* Patients who are currently receiving dialysis.
* Patients who participated in another clinical trial and received treatment in 4 weeks or have a plan for administration of another clinical trial treatment since Informed consent form sign date.
* Patients who have uncontrollable or serious disease.
* Patients who are unable to use appropriate methods of contraception during the study period.
* Patient whose tumor has not been removed or liver metastasis is confirmed.
Study of Bacteria on Mood and Bowel Symptoms in Patients With Irritable Bowel Syndrome

The purpose of this study is to determine whether probiotic bacterium Bifidobacterium longum (B. longum) can improve mood and bowel symptoms in patients with Irritable bowel syndrome (IBS). The patients will be treated with probiotic or placebo for 6 weeks. Their mood, memory, general well-being and bowel symptoms will be assessed before, at the end of the treatment and 4 weeks later. Brain activation pattern, changes in gut bacteria, metabolic profile and inflammatory markers will be also measured.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Irritable Bowel Syndrome based on Rome III Criteria
* Symptoms of mild to moderate anxiety and depression

Exclusion Criteria:

* Concurrent systemic disease and/or laboratory abnormalities considered by Investigators to be risky or that could interfere with data collection.
* Concurrent organic Gastrointestinal (GI) pathology other than benign polyps, diverticulosis, hemorrhoids, lipomas and melanosis coli.
* Psychiatric diagnosis other than anxiety or depression.
* Patients treated with therapeutic/standard doses of antidepressants and/or anxiolytics
* History of active cancer in the last 5 years, other than skin basal cells cancer
* Pregnant or breastfeeding women
* Treatment with antibiotics during the three months prior the study.
* Known or suspected allergies to the study products (eg maltodextrin).
* Patients who have heart pacemakers, metal implants, metal chips or clips in or around the eyeballs, artificial heart valves, metallic ear implants, bullet fragments or fixed brackets.
* High fiber diet (\>35 g/day for males, \> 25 g/day for females), consumption of high inulin containing foods (\>5 g/day).
* Consumption of any type of yoghurts or probiotic-containing products in the 4 weeks prior to the beginning of the study.
Sorafenib vs.TransArterial Chemoembolization Plus RadioTherapy in Hepatocellular Carcinoma With Macrovascular Invasion

To evaluate and compare the efficacy and safety of sorafenib versus trans-arterial chemoembolization plus external beam radiation therapy in patients with hepatocellular carcinoma invading major intrahepatic vessels

Current practice guidelines recommend only sorafenib for patients with hepatocellular carcinoma invading major intrahepatic vessels. However, recent data from observational studies suggest that the combination of transarterial chemoembolization and external beam radiotherapy would be as effective as sorafenib.

Eligibility Criteria:
Inclusion Criteria:

* Age \>19 years
* Child-Pugh class A liver function
* Performance status: Eastern Cooperative Oncology Group (ECOG) score 0 or 1
* Hepatocellular carcinoma (HCC) confirmed by dynamic CT or MRI, or by biopsy
* HCC invasion of first or second branch portal vein or hepatic vein or inferior vena cava
* Reserved unilateral portal blood flow at least in partial
* HCC size larger than 1 cm and less than 50% of total liver volume
* No confirmed extrahepatic metastasis
* Adequate hematopoietic function Hemoglobin ≥ 8.5 g/dL Absolute neutrophil count ≥ 750/mm3 Platelet count ≥ 30,000/mm3
* Creatinine \< 1.5mg/dL
* No plan for pregnancy or breast feeding. Active contraception.
* Willing to give informed consent

Exclusion Criteria:

* Prior history to or exposure of transarterial chemoembolization, external beam radiation to liver, or sorafenib
* Complete obstruction of hepatic outflow
* Confirmed extrahepatic metastasis of HCC
* HCC occupying more than 50% of liver volume
* Uncontrolled ascites of hepatic encephalopathy
* Prior liver transplantation
* Positive for human immunodeficiency virus (HIV)
* Active gastric or duodenal ulcer
* Other uncontrolled comorbidities or malignancy
* Inability to give informed consent
Physiologic Pacing for Symptomatic First-Degree Heart Block

The purpose of this study is to determine if physiologic pacing will improve symptoms and outcomes in patients with symptomatic first-degree heart block (pr interval ≥250ms).

The purpose of this study is to determine if physiologic pacing will improve symptoms and outcomes in patients with symptomatic first-degree heart block (pr interval ≥250ms). Patient will undergo a comparative effectiveness study where patients with symptomatic first-degree heart block (pr interval ≥250ms) undergo left bundle pacing (3830 lead) and are randomized to DDD-50 vs Managed Ventricular pacing-50 (MVP-50; AAI-DDD 50) and undergo a crossover at 3 months. This study will compare two standard of care options utilizing Food and Drug Administration (FDA) approved devices. Patients are evaluated at baseline, 3 months, and 6 months in terms of patient symptoms, exercise capacity, arrhythmia burden, and patient activity.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or above
* Ventricular Ejection Fraction (EF) \> 50%
* New York Heart Association (NYHA) class II-IV
* PR interval ≥250ms
* Narrow QRS duration (≤140ms) or prolonged QRS duration with typical Right Bundle Branch Block (RBBB) morphology on 12 lead ECG and sinus rhythm

Exclusion Criteria:

* Permanent atrial fibrillation (AF)
* Patients who are unable to perform a 6 minute hall walk
* Other serious medical condition with life expectancy of less than 1 year
* Lack of capacity to consent
* Pregnancy
* Contraindication to use of the relevant study device or leads (as per current manuals from manufacturer)
Trial of Nivolumab With FOLFOX After Chemoradiation in Rectal Cancer Patients

This is a phase II, prospective, open label, one-center study for evaluation of the addition of nivolumab to the chemotherapy phase of the neoadjuvant treatment for locally advanced rectal cancer patients. Subjects must have received no prior treatment for rectal cancer (chemotherapy, radiotherapy or surgery) and no prior treatment with checkpoint inhibitors.

Eligible subjects will receive chemoradiation for a period of 5 weeks, 6 cycles of chemo-immunotherapy (mFOLFOX6 + nivolumab) for a period of 12 weeks, once every 2 weeks, and will undergo surgery after 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Signed written IRB approved informed consent
* Age ≥ 18 years
* ECOG PS 0-1
* Subjects with histologically confirmed primary (non-recurrent) locally advanced rectal adenocarcinoma
* Stage T3-4 N0 or TX N+ according to baseline rectal EUS and PET-CT
* Patients who are planned for neoadjuvant chemoradiation and are surgical candidates
* No prior chemotherapy, radiotherapy or surgery for rectal cancer
* No prior radiotherapy to the pelvis, for any reason
* Presence of adequate contraception in fertile patients
* Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug
* Women must not be breastfeeding
* Ability to swallow tablets
* No previous (within the last 5 years) or concurrent malignancies, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix or basal cell carcinoma of the skin

Exclusion Criteria:

* Active autoimmune disease. \[Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll\]
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
* Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
* Pregnancy or breastfeeding
Flavopiridol, Gemcitabine, and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors

This phase I trial is studying the side effects and best dose of flavopiridol when given together with gemcitabine and irinotecan in treating patients with unresectable or metastatic solid tumors. Drugs used in chemotherapy, such as flavopiridol, gemcitabine, and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose and recommended phase II dose of flavopiridol in combination with gemcitabine and irinotecan in patients with unresectable or metastatic solid tumors.

II. Determine the toxicity profile of this regimen in these patients.

OUTLINE: This is a dose-escalation study of flavopiridol.

Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 15. Patients also receive flavopiridol IV over 60 minutes on days 2 and 16. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed solid tumor that is metastatic or unresectable
* Standard curative or palliative measures do not exist or are no longer effective
* No known brain metastases
* Performance status - ECOG 0-2
* Performance status - Karnofsky 60-100%
* More than 12 weeks
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin normal
* AST and ALT ≤ 2.5 times upper limit of normal
* Creatinine normal
* Creatinine clearance ≥ 60 mL/min
* No venous thrombosis within the past 6 months
* No thrombotic cerebrovascular accident within the past 6 months
* No myocardial infarction within the past 6 months
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No ongoing or active infection
* No prior allergic reaction attributed to compounds of similar chemical or biological composition to study agents
* No other concurrent uncontrolled medical condition that would preclude study participation
* No psychiatric illness or social situation that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Prior biologic therapy allowed
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
* Prior endocrine therapy allowed
* More than 4 weeks since prior radiotherapy and recovered
* Prior surgery allowed
* No other concurrent investigational agents
* No concurrent combination antiretroviral therapy for HIV-positive patients
Denosumab Fracture Intervention Randomized Placebo Controlled Trial in Japanese Patients With Osteoporosis

Evaluate the efficacy and safety of denosumab in the treatment of involutional (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral fracture(s)


Eligibility Criteria:
Inclusion Criteria:

* Involutional (postmenopausal and senile) osteoporosis with prevalent fragility vertebral fractures

Exclusion Criteria:

* Any underlying condition,(other than BMD) that might have resulted in abnormal bone metabolism
Asking People With Psoriasis About Lifestyle and Eating

The APPLE Study aims to understand if specific diet and lifestyle patterns are present in individuals with psoriasis and if these factors are correlated with psoriasis severity.

Prospective participants will be invited to read an information sheet and provide informed consent. Once informed consent is obtained, participants will be screened for eligibility with a short online screening questionnaire. Upon successful completion, participants will be directed to start the online multiple-choice survey with questions on psoriasis, diet and lifestyle patterns and complete a 4-day diet diary.

Eligibility Criteria:
Inclusion Criteria:

Adults (18 years of age or older) Dermatologist diagnosis of psoriasis Residents in the United Kingdom (UK) Fluent in English

Exclusion Criteria:

Minors (17 years of age or younger) Not medically diagnosed with Psoriasis Non-UK residents