cyrilzakka/clinical-trials huggingface dataset:
An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Participants With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Blast Crisis

This extension II study allowed for further follow-up of the disease under treatment with imatinib mesylate and allow the participants to continue to receive imatinib mesylate.


Eligibility Criteria:
Inclusion Criteria:

1. Participants with Philadelphia chromosome positive chronic myelogenous leukemia (CML) in myeloid blast crisis (including both newly diagnosed and the participants who received prior therapy for accelerated or blastic phases), defined as either:

1. ≥ 30% blast in peripheral blood and /or bone marrow
2. by flow cytometry criteria

2. To be categorized as "newly diagnosed", participants with CML in blast crisis were not to have received specific therapy for CML accelerated or blast phases, with the exception of interferon-alpha or hydroxyurea.

3. serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (SGPT) not more than 3 times the upper limit of the normal range (ULN) (or not more than 5 times the ULN if clinically suspected leukemic involvement of the liver), serum creatinine concentration not more than 2 times the ULN, and total serum bilirubin level not more than 3 times the ULN at the laboratory where the analyses were performed.

4. A negative pregnancy test in participants of childbearing potential.

Exclusion Criteria:

1. Participants with an eastern cooperative oncology group (ECOG) performance status score ≥ 3.
2. Participants previously treated for blast crisis were not to have received any of the following with respect to Day 1 of the study: busulfan within six weeks, interferon-alpha within 48-hours, hydroxyurea within 24-hours, homoharringtonine within 14 days, low-dose, moderate dose or high dose cytosine arabinoside within 7, 14 and 28 days respectively, anthracyclines, mitoxantrone, or etoposide within 21 days.
3. Participants receiving any hematopoietic stem cell transplantation within six weeks of Day 1.
4. Participants receiving any other investigational agents within 28 days of Day 1.
5. Participants with Grade 3/4 cardiac disease or any other serious concurrent medical conditions.

Other protocol-defined inclusion/exclusion criteria may apply.
Spectroscopy in Ovarian Cancer

Ovarian cancer is the eighth most common cause of cancer death in the world. Advanced stage at diagnosis is associated with lower survival rates, thus early detection appears to have an important role.

Raman Spectroscopy is a non-invasive technique that uses the interaction of light to identify the composition of the sample tested.

The aim of the project is to explore the use of spectroscopic techniques in the detection of ovarian cancer. There are two different assessments within the project:

1. Identify ovarian cancer in blood - Raman spectroscopic analysis will be performed on blood plasma taken from patients with suspected ovarian cancer.
2. Detect active cancer within post chemotherapy fibrotic tissue - Ex vivo Raman spectroscopic analysis of peritoneal, omental or ovarian tissues collected from patients undergoing surgical treatment for ovarian cancer.

The results of the spectroscopy will be correlated to clinical outcome and histological diagnosis respectively.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Symptoms suggestive of ovarian cancer
* Patients undergoing treatment of Ovarian Cancer

Exclusion Criteria:

* Less than 18 years of age
* Unable to consent to the study due to communication difficulties
* Unable to consent to the study due to lack of capacity
Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery

This study is safety and proof-of-concept study for oral prednisolone in the treatment of esophageal stricture after esophageal surgery. The patients who develop the severe esophageal strictures from 28 days after esophageal surgery are included. Primary outcomes are Safety and Success rate of this treatment.

Esophageal strictures are common complications after surgery and aggressive endoscopic submucosal dissection (ESD) for early-stage esophageal cancer and adenocarcinoma. However, patients, who develop esophageal strictures after extensive operations, usually develop refractory strictures. Although there are several treatments for refractory strictures, their utility is limited.

Yamaguchi and colleagues have developed new treatments using oral prednisolone. They have shown the safety and potential efficacy to prevent esophageal strictures after ESD. However, the efficacy and safety of oral prednisolone is not evaluated to esophageal stricture after esophageal surgery.

This study is safety and proof-of-concept study for oral prednisolone in the treatment of esophageal stricture after esophageal surgery. The patients who develop the severe esophageal strictures from 28 days after esophageal surgery are included. Primary outcomes are Safety and Success rate of this treatment.

Eligibility Criteria:
Inclusion Criteria:

* The patients who develop the severe esophageal strictures from 28 days after esophageal surgery

Exclusion Criteria:

* Pulmonary and cardiac disorders
* Liver and renal dysfunctions
* Allergic
* Pregnancy
* infectious disease
* Unsuitable condition
Quality of Life in RECTal Cancer - a Prospective Multicenter Cohort Study

Rectal cancer is a common type of cancer occuring more frequently in men but also common in women. Almost 60% of the patients survive 5-years and the treatment has been continuously developed in the last three decades. The aim of the QoLiRECT study is to increase the knowledge about symptoms, functional impairments, quality of life (QoL) and psychological and socioeconomic burden in an unselected population of rectal cancer patients.

Rectal cancer is more frequent in men than in women and is relatively uncommon before the age of 50. The prognosis for rectal cancer has improved over the last decades2. Almost 60% of all patients survive more than five years, and because of advances in early detection and treatment, this number is expected to increase in the future1. Treatment of rectal cancer varies depending on the stage of the disease at diagnosis. For some patients, operation is the only treatment. For others, surgery is combined with radiotherapy, chemotherapy or both. The two most common operative procedures are the sphincter-preserving anterior resection (AR) and the abdominoperineal resection (APR) - the latter results in a permanent colostomy. Patients with generalised disease at diagnosis receive palliative treatment, which may include chemotherapy and radiotherapy as well as surgery.

Rectal cancer comes with a high risk of local recurrence, i.e. return of the tumour within the pelvis after a presumed curative resection. Local recurrence is difficult to treat and often very painful and distressing for the patient. Some local recurrences will be candidates for second line surgery, as is also true for some distant metastases.

The aim of the QoLiRECT study is to increase the knowledge about symptoms, functional impairments, quality of life (QoL) and psychological and socioeconomic burden in an unselected population of rectal cancer patients. Symptoms such as incontinence, pain, fatigue and impaired sexual function3 are common with this disease. Bodily changes, caused by the treatment or the disease itself, may lead to functional impairments and psychological, social, emotional and economical restraints. Conventional outcome measures such as morbidity and survival reveal little about these things.

Eligibility Criteria:
Inclusion Criteria:

* All patients presenting at the participating hospitals with newly diagnosed rectal cancer, regardless of stage at diagnosis and plans for treatment, will be eligible for inclusion.

Exclusion Criteria:

* Age below 18 years at diagnosis.
* No informed consent received or withdrawal of informed consent.
Single-Ascending Dose Study of AMG 333 in Healthy Subjects and Subjects With Migraines

The primary purpose of this study is to determine whether AMG 333 is safe and well tolerated in healthy subjects and subjects with migraines. As part of the secondary objectives, this study will characterize the pharmacokinetic (PK) profile of AMG 333, as well as characterize the effect of AMG 333 on the cold pressor test (CPT)-induced increase in blood pressure after single oral doses in healthy subjects and subjects with migraines

This is a randomized, double-blind, placebo-controlled, ascending single-dose study evaluating AMG 333 in healthy subjects and subjects with migraines. The study will consist of 8 cohorts: 7 cohorts of healthy subjects and 1 cohort of subjects with migraines. For cohorts 1 to 7, 8 subjects each will be enrolled, and subjects will be randomized such that 6 subjects will receive AMG 333 and 2 subjects will receive placebo (3:1 ratio). In cohort 8, up to 24 subjects with migraines will be enrolled, depending on enrollment rate and emerging safety and tolerability data. These migraine subjects will be randomized to receive AMG 333 or placebo in a crossover fashion. Both healthy and migraine subjects will be monitored in house for 4 days then allowed to return home for the remainder of the 14 day observation period. Both healthy and migraine subjects will keep headache diaries.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects with or without migraines ≥18 and ≤55 years of age at the time of screening, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the Amgen physician.

Exclusion Criteria:

* History or evidence of a clinically significant disorder, condition, or disease that, in the opinion of the investigator and Amgen physician, would significantly impair pain perception (eg, history of stroke, history of neuropathy) or interfere with evaluation, procedures, or study completion.
Ertapenem Versus Meropenem/Imipenem for ESBL+ Gram-negative Infections

Adult patients with ESBL-producing Gram negative infections are randomized to receive ertapenem or meropenem/imipenem. Clinical and microbiological responses between both groups are compared.

Ertapenem is active against ESBL-producing Gram negative bacteria. This study is conducted to determine if ertapenem is effective against ESBL-producing Gram negative infections similar to meropenem/imipenem.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients aged \>18 years with documented ESBL +ve GNB infection
* Receive meropenem or imipenem/cilastatin as empiric antibiotic therapy

Exclusion Criteria:

* Having been treated with meropenem or imipenem/cilastatin for longer than 72 hours
* Have active P. aeruginosa co-infection
* Pregnancy or breast feeding
* Allergy to carbapenems
Effect of Vitamin D on Outcome of Assisted Reproductive Technology(ART);

Vitamin D has many biological functions. Vitamin D receptors are widely distributed in the male and female reproductive system. Animal experiments have shown that vitamin D deficiency can affect hormone synthesis and gamete formation, reduce sperm motility, and may be related to diseases such as PCOS and endometriosis. Population studies suggest that vitamin D may be related to androgen levels and sperm quality, but whether vitamin D affects the outcome of assisted reproduction is controversial and inconclusive. This study intends to explore whether vitamin D affects the outcome of assisted reproduction through a large sample cohort study.

Vitamin D plays an important role in reproduction, while there is high prevalence of vitamin D deficiency. Serum 25(OH)D was categorized according to clinically accepted ranges for vitamin D deﬁciency (\<20 ng/mL), insufﬁciency (20-30 ng/mL), and replete (\>30 ng/mL).

This is a retrospective cohort study of about 2000 infertile couples who undergo their ﬁrst IVF/ICSI and IUI cycle at Reproductive Medicine Center of Peking University Third Hospital. Patients will be excluded if they refuse to be recruited. Serum samples are collected the day when patients first time to Reproductive Medicine Center and were stored at -20℃ until assayed. Life style of patients is collected by questionair. Vitamin D status is measured by assessing circulating levels of 25(OH)D in frozen, never previously thawed serum samples using radioimmunoassay.

The investigators will comapere the ART outcomes in different groups according to serum 25(OH)D status.

In female, the primary outcome is clinical pregnancy rates deﬁned as the presence of an intrauterinesac with an embryonic pole demonstrating cardiacactivity at 7 weeks of gestation. Secondary outcomes are quality of embryo, positive hCG rates and live birth rates.

In male, the primary outcome is semen quality, such as semen volume, sperm concentration, sperm motility, morphologically normal percent and progressive motile spermatozoa percent. Secondary outcomes are clinical pregnancy rates and live birth rates.

Eligibility Criteria:
Inclusion Criteria:

infertile couples who undergo their ﬁrst IVF/ICSI and IUI cycle at Reproductive Medicine Center of Peking University Third Hospital.

Exclusion Criteria:

refusing to be recruited.
Learning Curve of Double-wire Cannulation Technique During Endoscopic Retrograde Cholangiopancreatography (ERCP)

Selective cannulation is considered the most challenging step for most of endoscopic retrograde cholangiopancreatography (ERCP). Wire-guided cannulation is the standard technique for initial cannulation. When meeting difficulty, double wire technique (DWT) is widely used. With one guidewire occupying pancreatic duct(PD) , the following cannulation of CBD with a sphincterome preloaded with another guidewire often becomes feasible.

When performing DWT, a sphincterotome should enter the common duct of papilla through a small orifice and be placed in the left and upper direction of PD guidewire. Then another guidewire can be advanced into bile duct. As an advanced cannulation technique, DWT can be successfully performed in up to 80% of difficult patients. However, it can be technically difficult, especially for trainees or endoscopists without adequate experience.

Here we planned to prospectively record the procedures of double-wire cannulation by two trainees without prior experience of DWT. This study aims to delinate the learning curve of DWT and its safety by trainees.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-90 with native papilla
* patients with diffcult cannulation of bile duct
* Inadvertent pancreatic duct cannulation

Exclusion Criteria:

* Contraindications of ERCP
* Major or minor pancreatic duct as the targeted duct
* Prior EST or needle-knife precut before DWT
* Surgically altered gastrointestinal anatomy
* Papillary carcinoma or stone impaction within papilla
* Complete pancreas divisum
* Pregnant or breastfeeding women
* Unwilling or inability to provide consent
Comparison Study of Vasovist® Magnetic Resonance Angiography (MRA) and an MRA With a Conventional Extracellular Contrast Agent With X-ray Angiography in Patients With Peripheral Artery Disease

The particular aim of this study is the comparison of the diagnostic results of MRA images upon application of Vasovist (gadofosveset), a contrast agent not yet available on the market, with the MRA images upon application of a conventional extracellular contrast agent. A catheter angiography, which will be performed as a routine diagnostic procedure for vascular diseases, will serve as an evaluation standard.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a certain circulation disorder (aortoiliac disease Fontaine-stage IIb / IV) and an indication for the evaluation of the peripheral run-off arteries from the infrarenal aorta to the calves
* Patients who are scheduled for X-ray angiography and magnetic resonance angiography (MRA) of the arteries mentioned above
* Patients who have had a contrast-enhanced MRA examination of the arteries mentioned above using a standard extracellular contrast agent performed within 1 - 7 days prior to the study MRA examination

Exclusion Criteria:

* Less than 18 years of age
* Women who are pregnant, breast feeding or who are of childbearing potential and have not had a negative urine pregnancy test the same day as the study MRA examination
* Requiring immediate therapy for their vascular disease or in whom conduct of all three angiographic procedures is not possible
* Not being able to remain lying down for at least 45 - 60 min
* Patients with a history of serious allergic reactions to any allergen including drugs and contrast agents or with a history of sickle cell disease or other hemolytic anemia
* Having any contraindication to magnetic resonance imaging (MRI) examination or specifically for MRA (e.g. pacemaker, recent wound clips, and severe claustrophobia)
A Study of the Effect of Vemurafenib on the Pharmacokinetics of Acenocoumarol in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy

This open-label, multicenter, 3-period, fixed-sequence study will evaluate the effect of multiple doses of vemurafenib on the pharmacokinetics of a single dose of acenocoumarol in participants with BRAFV600 mutation-positive metastatic malignancies. Participants will receive a single dose of acenocoumarol 4 mg orally on Day 1 and Day 23, vemurafenib 960 mg orally twice daily on Days 4-26. After completion of pharmacokinetic assessments on Day 26, eligible participants will have the option to continue treatment with vemurafenib as part of an extension study (GO28399 \[NCT01739764\]).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18-70 years of age
* Patients with either unresectable Stage IIIc or IV BRAFV600 mutation-positive metastatic melanoma or other malignant BRAFV600 mutation-positive tumor type and who have no acceptable standard treatment options
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Full recovery from any major surgery or significant traumatic injury at least 14 days prior to the first dose of study treatment
* Adequate hematologic and end organ function
* Female patients of childbearing potential and male patients with female partners of childbearing potential must agree to use 2 effective methods of contraception as defined by protocol during the course of the study and for at least 6 months after completion of study treatment

Exclusion Criteria:

* Prior treatment with vemurafenib or other BRAF inhibitor within 42 days of Day 1
* Prior anti-cancer therapy within 28 days (6 weeks for nitrosureas or mitocyn C, or 14 days for hormonal therapy or kinase inhibitors) before the first dose of study treatment Day 1
* Palliative radiotherapy within 2 weeks prior to first dose of study treatment Day 1
* Experimental therapy within 4 weeks prior to first dose of study treatment Day 1
* History of clinically significant cardiac or pulmonary dysfunction, including current uncontrolled Grade \>/=2 hypertension or unstable angina
* Current Grade \>/=2 dyspnea or hypoxia or need for oxygen supplementation
* History of myocardial infarction within 6 months prior to first dose of study treatment
* Active central nervous system lesions (i.e. participants with radiographically unstable, symptomatic lesions)
* History of bleeding or coagulation disorders
* Allergy or hypersensitivity to vemurafenib or acenocoumarol formulations
* History of malabsorption or other condition that would interfere with the enteral absorption of study treatment
* Participants with VKORC1 mutations (1639G\&#8594;A, 1173C\&#8594;T) in either one allele (heterozygous)or two alleles (homozygous)
* Participants with CYP2C9\*3 mutations in either one allele (heterozygous) or two alleles (homozygous)
* History of clinically significant liver disease (including cirrhosis), current alcohol abuse, or active hepatitis B or hepatitis C virus infection
* Human immunodeficiency virus (HIV) infection requiring antiretroviral treatment, or AIDS-related illness
* Pregnant or lactating women
Web-based Patient Education Program to Manage Side Effects of Allogeneic Stem Cell Transplant

The purpose of this study is to develop an interactive web-based patient education program to help educate patients about the increased risk of MS and its cardiac risk factors following allo-SCT and to inform and motivate patients how to make lifestyle changes. This program will be used in addition to counseling at participants clinic visits. The investigators are not changing the recommendations for prevention and management of these conditions, but rather are trying to improve the way they provide this education to patients.


Eligibility Criteria:
Inclusion Criteria:

* The option to participate will be offered to male and female allo-SCT patients at MSK ≥ 21 years of age who are greater than 90 days post-transplant and followed in or referred to the adult allo-SCT survivorship clinic at MSK
* The option to participate will be offered to male and female allo-SCT patients at MSK ≥ 21 years of age who are greater than 90 days post-transplant and disease free, but have not yet been referred to the survivorship clinic
* Able to understand written and oral English

Exclusion Criteria:

* Patients less than 90 days post-transplant
* Patients without internet access
* Adult post-transplant patients who have relapsed prior to study recruitment
Study of Immune Cells in Obese Patients With Type 2 Diabetes Mellitus Treated With Liraglutide

The purpose of this study is to determine the effect of exogenous glucagon-like peptide-1 on the immune system i.e on the regulation of immune cells important in diseases such as obesity and diabetes.

The hypotheses are:

* Glucagon-like peptide-1 has an immunological effect observed by studying immune cells in the blood
* Treatment with glucagon-like peptide-1 increases the number of immune cells in the blood
* Treatment with glucagon-like peptide-1 leads to a more anti-inflammatory cytokine profile in the blood


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* BMI \> 27 kg/m2
* Planed start of treatment with liraglutide
* Age \> 18 years

Exclusion Criteria:

* Infection or active inflammatory disorder
* Immunomodulating treatment (i.e nonsteroidal antiinflammatory drugs, glucocorticoids)
* Smoking
* Alcohol consumption \> 14 beverages/week
* Former bariatric surgery
Fibromyalgia, Exercise Adherence and Barriers

We aimed to investigate adherence to exercise and perceived barriers to exercise in patients with fibromyalgia who were advised to exercise.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with fibromyalgia according to ACR 2016 criteria
* Female
* To be informed about the benefits of exercise, the importance of exercise compliance and to be shown the exercise program in practice and to be given a printed form

Exclusion Criteria:

* Having a systemic or mental disease that may prevent exercise
Simple Home-Based Exercise for Knee Osteoarthritis

1. Simple home-based standing balance training and isometric knee extension exercise for 4 weeks would improve functional ability and knee muscle strength of patients with knee osteoarthritis.
2. The outcome of standing balance training is different from isometric knee extension exercise.


Eligibility Criteria:
Inclusion Criteria:

* Clinical criteria for knee osteoarthritis

Exclusion Criteria:

* cardiovascular disease
* Parkinsonism
* osteoporosis
* inability to walk for 15 meters
* intra-articular injections