cyrilzakka/clinical-trials huggingface dataset:
A Phase II Trial of Exploring the Predictive Factors of TX and XELOX Regimen in the First Line Treatment of MGC

Platinum, fluorouracil and taxane based regimen are all acceptable in the first line treatment of metastatic gastric cancer. The TX and XELOX regimen are two common regimen used in MGC. whichever regimen is used, the average response rate is less than 50%. So a rather part of patients can't get benefit from the treatment. It is urgent to find out the predictive factors of these regimens in order to get a higher response and better survival outcome.

Patients with MGC will be treated with TX or XELOX regimen. Before treatment, 14 days after treatment and after progression, the blood sample will be collected. Primary tumor blocks will also of collected. These samples will be used to detect predictive factors of the two types first line therapy.

Eligibility Criteria:
Inclusion Criteria:

* Chemo-naive patients with metastatic, unresectable, histologically confirmed gastric or Gastroesophageal adenocarcinoma; Patients who received adjuvant chemotherapy, the duration from the last therapy to relapse at least longer than 6 months
* Patient must have at least one measurable lesions (RECIST 1.1)
* 18 Years to 75 years
* Written informed consent obtained
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Patients must have adequate organ and marrow function as defined below:
* neutrophilicgranulocyte greater than/equal to 1,500/mm3;
* platelets greater than/equal to 90,000/ mm3;
* hemoglobin greater than/equal to 9 gm/dL (may be transfused to maintain or exceed this level);
* total bilirubin less than/equal to 1.5 within institutional upper limit of normal (IULN);
* Aspartate Transaminase (AST,SGOT)/Alanine transaminase (ALT,SGPT) less than/equal to 2.5 times IULN
* serum creatinine less than/equal to 1.5 x IULN.

Exclusion Criteria:

* Active clinically serious infections (\> grade 2 NCI-CTC version 3.0, National Cancer Institute-Common Terminology Criteria for Adverse Events)
* Symptomatic metastatic brain or meningeal tumors
* History of organ allograft
* Patients undergoing renal dialysis
* chronic inflammatory bowel disease; ileus; genetic fructose intolerance
* Patients who received adjuvant chemotherapy and the duration from the last therapy less than 6 months
* Receive previously radiotherapy in measurable regions
* Pregnancy or lactating status
* Concurrent malignancy other than nonmelanoma skin cancer, or in situ cervix carcinoma
* Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months
* Acute or subacute intestinal occlusion or history of the inflammatory bowel disease
* Any factors that influence the usage of oral administration
Clinical Investigational Plan: Evaluation of the Performance of the Motus Cleansing System

The Motus GI Colon Cleansing device is intended to facilitate intra-procedural cleaning of a poorly prepared colon by irrigating the colon and evacuating the irrigation fluid and feces.

The main objective of the study is to evaluate the performance of the Motus cleansing system used in conjunction with screening, diagnostic or surveillance colonoscopy

Eligibility Criteria:
Inclusion Criteria:

1. Subjects being considered for diagnostic, screening or surveillance colonoscopy
2. Subjects in the age range of 18-75 years inclusive
3. Subjects with Body Mass Index (BMI) within the range of 18.5-35 inclusive
4. Subject has signed the informed consent

Exclusion Criteria:

1. Subjects with known Inflammatory Bowel Disease
2. Subjects with known diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease
3. Subjects with known or detected (during colonoscopy) bowel obstruction
4. History of prior surgery to colon and/or rectum
5. ASA≥IV
6. Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on medical history)
7. Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical history)
8. Subjects taking anticoagulants drugs (excluding aspirin) and dual anti-platelet therapy
9. Pregnancy (as stated by patient) or breast feeding
10. Subjects with altered mental status/inability to provide informed consent
11. Patients who have participated in another interventional clinical study in the last 2 months
The 3q25 rs2305619 Polymorphism Associates With Microvascular Obstruction in STEMI

The investigators enrolled 217 patients with acute STEMI undergoing primary PCI. The rs2305619 polymorphism was evaluated by real time PCR and plasma PTX3 concentration was assessed by human PTX3 ELISA kit.

The investigators enrolled 217 patients with acute STEMI undergoing primary PCI in a tertiary care academic cardiovascular center. The rs2305619 polymorphism was evaluated by real time PCR and plasma PTX3 concentration was assessed by human PTX3 ELISA kit. The primary outcome of the study was the incidence of coronary microvascular obstruction defined as thrombolysis in myocardial infarction (TIMI) grade \<3 flow after primary PCI or TIMI grade 3 flow with myocardial blush grade 0 or 1. Patients were grouped based on the genotypic variants (AA, AG and GG). The primary outcome was compared among the three variants, as well as the PTX3 concentration and 30-day mortality.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute STEMI with symptom onset \<12 h and treated by primary PCI

Exclusion Criteria:

* STEMI patients who received fibrinolytic therapy
Protocol to Permit the Acquisition of Circulating Tumor Material in Pancreatic Diseases

The purpose of this study is to collect blood samples to detect potential markers of pancreatic cancer in the blood and link these findings to medical and health information. Information from this study may help to provide insight into the detection of pancreas cancer in the blood before it can be found by other methods or provide a method of monitoring the status of pancreatic cancer throughout a treatment course. Another purpose of this study is to collect blood to create a biobank.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must be a patient at the Hospital of the University of Pennsylvania

   * The subject must be under evaluation and/or treatment for a pancreatic disease
   * The subject must be under evaluation and/or treatment for a non-pancreatic disease. For example, patients undergoing routine colonoscopy within the clinical practice will be asked to consent to provide control samples.
2. The subject must be able to provide informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf
3. The subject must be 18 years of age or older

Exclusion Criteria:

1. The subject or acceptable surrogate does not provide informed consent
2. Subject is a prisoner
3. Subject is under 18 years of age
Investigation of Lumbo-sacral Instability Using Custom Made Table - a Pilot Study

The aim of the study is to evaluate the feasibility and validity of conventional radiographs of the lumbo-sacral spine when the patient is lying on a special table which facilitates maximal lumbo-sacral flexion. The results gained from the radiographs with the patient on the table will be compared with those gained from standard flexion-extension radiographs of the lumbo-sacral spine.

After enrollment in the study patients will complete a set of questionnaire concerning degree, extent and quality of their low back problem. Afterwards a lateral conventional radiograph of the lumbar spine with the patient on a custom made positioning table will be taken. The table facilitates optimal flexion of the lumbar spine. Afterwards sagittal translation and rotation are measured on the flexion-extension radiographs and the radiograph taken on the custom made table. Differences between the measurements will be determined.

Eligibility Criteria:
Inclusion Criteria:

* chronic low back pain (≥ 3 months)
* clinical suspicion of lumbo-sacral instability
* functional conventional radiographs of lumbar spine
* pain intensity \> 4 / 10 on visual analogue scale
* age 20-60 years

Exclusion Criteria:

* radicular pain
* pain at more than two locations
* lumbar spine surgery
* scoliosis
* lumbar spondylolysis
* lumbar spondylodiscitis
* anatomic aberrations of lumbar spine
* unconsolidated spine fractures
* neurologic deficits
* spine tumor
* neuromuscular disease
* rheumatic disease
* severe osteoporosis
* radiotherapy within the last 5 years
* pregnancy
* insufficient German language skills
* no informed consent
Fertility After Prostate Brachytherapy

Although brachytherapy toxicity data on erectile dysfunction, urethral dysfunction and bladder and bowel impact has been collected for a number of years, there is limited information on its effect on male fertility. This study aims to investigate the effect of brachytherapy on fertility

Brachytherapy is a commonly employed technique in the treatment of all prostate cancer risk groups. It delivers a high radiation localised to the prostate gland. The effects of this on fertility have not been systematically studied. An increasing number of younger men for whom fertility is an issue are being diagnosed with prostate cancer and may be offered brachytherapy amongst their treatment choices. This study therefore addresses this issue with a systematic evaluation of sperm count and quality before and after both high dose rate and low dose rate brachytherapy.

Eligibility Criteria:
Inclusion Criteria:

* Male
* 18 years or older
* Receiving brachytherapy monotherapy; High or Low dose rate
* Ability to ejaculate
* Able to provide written informed consent

Exclusion Criteria:

* History of infertility or vasectomy
* Previous chemotherapy or pelvic radiotherapy
* Prior use of androgen deprivation therapy
* 5 alpha-reductase inhibitors within the last 4 months
* Alpha blockers within 7 days of semen collection
rhGAA in Patients With Infantile-onset Glycogen Storage Disease-II (Pompe Disease)

Glycogen Storage Disease Type II ("GSD-II"; also known as Pompe disease) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with GSD-II, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. This study is being conducted to evaluate the safety and effectiveness of recombinant human acid alpha-glucosidase (rhGAA) as a potential enzyme replacement therapy for GSD-II. Patients diagnosed with infantile-onset GSD-II who are greater than 6 months old, but less than or equal to 36 months old will be studied.


Eligibility Criteria:
Inclusion Criteria:

* The patient or the patient's legal guardian(s) must provide written informed consent prior to any study-related procedures being performed
* The patient must have a clinical diagnosis of infantile GSD-II as defined by: (a) the patient has/had documented (in a medical record) onset of symptoms compatible with GSD-II by 12 months of age; (b) the patient has documented GAA deficiency as illustrated by an endogenous GAA activity less than or equal to 2% of the mean of the normal range as assessed in cultured skin fibroblasts; AND (c) the patient has a Left Ventricular Mass Index greater than 2 standard deviations above the mean for age
* The patient is greater than 6 months old and less than or equal to 36 months old at the time of the first dose of rhGAA
* The patient and his/her legal guardian(s) must have the ability to comply with the clinical protocol

Exclusion Criteria:

* Signs and symptoms of cardiac failure and an ejection fraction less than 40%
* Major congenital abnormality
* Clinically significant organic disease (with the exception of symptoms relating to GSD-II), including clinically significant cardiovascular, hepatic, pulmonary, neurologic, or renal disease, or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the trial or potentially decrease survival
* Use of any investigational product within 30 days prior to study enrollment
* Received enzyme replacement therapy with GAA from any source
Evaluation of the Effectiveness of Pharmacists in Implementing the SCRIPT Protocol

There is a significant need for nicotine cessation programs for pregnant women in Spokane County. SCRIPT has been proven to be an effective method for smoking cessation in pregnant women. This study will evaluate the success of SCRIPT delivered by pharmacists. At the end of the study, the investigators hope to have three questions answered: 1) what is the quit rate of pregnant women in the Spokane area who receive the SCRIPT intervention delivered by pharmacists? 2) How does the quit rate compare to the quit rates of SCRIPT programs delivered by other health care providers as documented in the literature? And 3) Does the SCRIPT intervention have a significant effect on quit rates for pregnant women compared to current Spokane county quit rates? Urine cotinine tests will be used to document smoking status before delivery of the SCRIPT program, approximately one week after quit date and at \>36 wks gestation or at delivery for study participants.

1. The goal of this project is to evaluate the success of pharmacists in delivering the SCRIPT smoking cessation program. The research questions that need to be addressed are: i. What is the quit rate of pregnant women in the Spokane area who receive the SCRIPT intervention delivered by a pharmacist? ii. How does this quit rate compare to the quit rates of other SCRIPT programs given by other health care providers (social workers, nurses, etc.)? iii. Does the SCRIPT intervention have a significant effect on quit rates for smoking pregnant women compared to current Spokane county quit rates?

Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* nicotine use
* English speaking
* 18 years of age or older

Exclusion Criteria:

* Males due to pregnancy status not applicable
GSD VI and GSD IX Natural History

Collection and review of clinical information related to Glycogen Storage Disease Type VI (GSD VI) OR Glycogen Storage Disease Type IX (GSD IX) generated during clinic visits.

This natural history study will serve as a repository of clinical, laboratory, and biochemical information on individuals with GSD VI or GSD IX. This information will allow a more definitive description of glycogen phosphorylase (GP) and phosphorylase kinase (PhK) deficiency to be developed, which will permit development of treatment strategies for these diseases.

Duke will be the only site where this study takes place. However, since these are rare disorders, participants who receive care at other institutions will be included. The investigators will collect retrospective data from patient charts on diagnosed individuals, as far back as necessary to capture the clinical course of the disorder. Prospective data collected from patient charts after enrollment will be captured as well. Participant's medical records will be continually reviewed for the duration of the study.

Data will be collected from medical records and will only pertain to clinically relevant information, including, but not limited to: demographic and diagnostic information, tissue biopsy results, medical and family history, review of systems, imaging studies, results of liver and/or muscle testing, and urine and blood laboratory results.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of GSD VI or GSD IX via:

  * Two variants in the PYGL, PHKA1, PHKA2, PHKG1, PHKG2, or PHKB gene (or one variant with evidence of disease). Note: for males, one variant in the PHKA1 or PHKA2 gene is sufficient for inclusion.
  * Deficient GP activity or PhK activity per enzymology
  * Histology as confirmed by clinician
* Pregnant women with a diagnosis of GSD VI or GSD IX will be included
* Able to provide informed consent for self (adults) or affected individual (minor or adults with a legally authorized representative)
* Able to provide consent for release of medical records

Exclusion criteria:

* Unable to provide informed consent for participation for one's self or by legally authorized representative/legal guardian/parent
The Right Intervention for the Right Patient

Complicated and expensive interventions are used to treat unspecific low back pain and the intervention is not always targeted the patients specific problems.It is therefore not surprising that a large fraction of unspecific low back pain patients do not respond very well to the usual biopsychosocial intervention.

We would therefore like to identify the patients specific problems regarding the patients biomedical, psychological, and social needs.

Two quality assurance investigations are performed in the The Back Research Center Clinic, where one is published in The Spine. The systematics of Health Technology Assessment was used to throw light on important indicators in relation to Health Technology aspects, patient aspects, organisational aspects and economical aspects. At 12 months follow up in 1999, approximately one third of the patients stated that their low back pain was unchanged or worse. In 2004 in a new investigation this fraction was larger. Therefore it seems relevant to be able to identify the patients early in their course in the back ambulatory.

A Norwegian project has shown that when one divides the patients into 3 levels of severity, then the interdisciplinary biopsychosocial intervention had best effect in the intermediary and severe groups. Conversely the mono disciplinary intervention had best effect on the least severe patient group.

Therefore we would like to combine elements from the typical clinical investigation with a screening for psychosocial factors in order to sort patients according to their individual needs.

Even though the bio-psycho-social elements are a coherent continuum one can arbitrarily combine them in 4 groups of increasing complexity.

* mainly biological
* both biological and psychological
* both biological and social
* both biological, psychological and social It is probably not good enough to give more or less the same type of somatic treatment to all unspecific low back pain patients. It is important to take into account all three elements, the severity of the elements, and the combination of elements. To be able to do this it is important to use a combination of screening instruments that can isolate and quantify the manifestations of the three elements in the patients.

Eligibility Criteria:
Inclusion Criteria:

* Unspecific low back pain
* Level of low back pain must be at least equal to leg pain
* Patients must have been sick listed during the past 12 months
* Age \> 17 years and \< than 60

Exclusion Criteria:

* Modic changes as seen on MRI
* Direct or progressive paresis or Cauda equina syndrome
* Known MB Bechterew or Sacroiliitis
* Suspicion of other serious malignancy
* Alcohol or medicine abuse
* A screening result of more than 30 in the Beck Depression Inventory
Glaucoma Screening Using Dynamic Analysis of Computerized Pupillary Light Reflex Assessment Device

To explore an effective diagnostic tool of glaucoma through the dynamic analysis of computerized pupillary light reflex assessment device (CPLRAD) pupillography based on iris recognition techniques and investigate its feasibility in glaucoma screening.

Glaucoma is the leading cause of irreversible blindness worldwide, which is characterized by progressive loss of retinal ganglion cells (RGCs) and their optic nerve axons. Early diagnosis and treatment can effectively prevent the progression of the disease and avoid blindness. The damage of RGCs appears in the early stage of glaucoma, and the asymmetry of the eyes has also been observed clinically. CPLRAD may serve as an effective screening tool for glaucomatous optic neuropathy, since they can dynamically detect abnormal pupillary responses from a novel sequence of light stimuli and functionally-shaped stimuli. The current theoretical evidence of relative afferent pupillary defect/pupillary light reflex (RAPD/PLR) as a functional test for predicting nerve damage is insufficient, and pupil detection technology is not yet mature. Therefore, the investigators want to complete these tasks: 1) collect the clinical examination data and objectively measure the pupil dynamic parameters monocularly and/or binocularly as indicators from the retina and optic nerve in glaucoma patients 2) design RAPD/PLR detection technology and develop dynamic analysis system; 3) verify the feasibility of RAPD/PLR applied to early glaucoma screening through clinical trials. The pupil image dynamic analysis and iris recognition system will provide a simple, inexpensive and non-invasive screen tool, and is highly reliable and cost-effective.

Eligibility Criteria:
Inclusion Criteria:

* with open angles on gonioscopy
* best-corrected visual acuity ≥0.5
* spherical refraction within ±6.0 diopters (D), and cylinder correction within 3.0 D

Exclusion Criteria:

* eyes with any evidence of physical abnormality of the iris or pupils on slit-lamp examination
* eyes with a history of trauma or inflammation
* undergone an intraocular surgery or laser within the previous 6 months /except uncomplicated cataract surgery
* using systemic or topical medications that could affect pupil responses, including pilocarpine or atropine
* presence of any media opacities that prevented good quality optical coherence tomography (OCT) or fundus images
* presence of any retinal or neurological disease other than glaucoma abnormal ocular motility that prevents binocular fixation (eg, nystagmus, strabismus)
* with severe system diseases or psychiatric disorders
A Study Evaluating the Effect of Etoricoxib and Indomethacin in the Treatment of Acute Gout (0663-081)(COMPLETED)

A study to evaluate the effects of etoricoxib and indomethacin in the treatment of acute gout.


Eligibility Criteria:
Inclusion Criteria:

* Males or females at least 18 years of age who have acute gout.
An Observational Study of MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in First-Line in Patients With Diffuse Large B-Cell Lymphoma

This multicenter, observational study will evaluate the correlation between clinical and biological factors and International Prognostic Index (IPI) as prognostic factors in patients with diffuse large B-cell lymphoma receiving first-line treatment with MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy. Eligible patients receiving treatment according to standard of care and local guidelines will be followed for the duration of treatment (approximately 8 months) and during 1 year of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>18 years of age
* Patients with diagnosed diffuse large B-cell lymphoma in first-line treatment with R-CHOP

Exclusion Criteria:

* Prior chemotherapy treatment for diffuse large B-cell lymphoma
* Contra-indications or exclusion criteria according to the Summary of Product Characteristics for MabThera/Rituxan
A Study of MK-2225 in Healthy Participants (MK-2225-003)

The purpose of the study is to learn about the safety of MK-2225, including how well people tolerate it. Researchers also want to learn what happens to different doses of MK-2225 in a person's body over time.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is in good health before randomization
* Body Mass Index (BMI) ≤32 kg/m\^2, inclusive

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* History of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* History of hypersensitivity to the MK-2225 drug substance, its inactive ingredients or the placebo (normal saline)