cyrilzakka/clinical-trials huggingface dataset:
An Interactive Empowerment Tool for Breast Cancer Patients

The study is aimed to verify the effect of an online interactive tool on patient empowerment. The tool is based on a validated psychological questionnaire administrated to breast cancer patients before their first encounter with physician.

The study is intended to develop an IEm (Interactive Empowerment) tool aimed at enhancing physician-patient experience by providing physicians a personalized patient's profile, accompanied by a list of recommendations to suggest him how to interact with that specific patient on the basis of his/her personal profile. Developed in the framework of the FP7 project "P-Medicine", the IEm tool uses the ALGA-BC questionnaire, a recent validated instrument specifically developed to perform a brief evaluation of the breast cancer patients' psychological status, to provide the physician a patient's profile based on 8 factors. As soon as the questionnaire has been completed, the patient's answers are automatically elaborated and sent to the physician's computer. Provided to the physicians at the very beginning of the visit, such information is supposed to be crucial for them to find a tailored way to communicate with the patient. Moreover, in order to help physicians to correctly interpret the patient's score, any time the scores are out of a certain range (normal values) they will receive a recommendation that helps them to find the best way to interact with the patient. Supposing that the patient empowerment can be reached through the improved patient's participation in the clinical process, we argue that a more effective and personalized interaction between patient and physician may have a key role in promoting it.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is aged 18 to 74 years at randomisation.
2. The patient has been diagnosed as having a primary breast cancer requiring a radical surgery
3. The patient is able to understand the Informed Consent Form, and understand study procedures.
4. The patient has signed the Informed Consent Form.

Exclusion Criteria:

1. The patient has a recurrent breast cancer diagnosis
2. The patient has an overt psychiatric illness that would interfere with the measurement of the psychological variables included in the questionnaire
3. Inability to freely consent to take part in the study
4. Inability to understand the study materials.
5. Current participation in another clinical trial relating to the breast cancer treatment
6. Any condition that, in the researcher's opinion, compromises the subject's ability to meet protocol requirements or to complete the study.
Comparative Study Using Dermabrasion vs CO2 Laser & Collagen Dressing vs Vaseline Gauze in MKTP

The purpose of this study is to:

1. Compare two different techniques in the melanocyte keratinocyte transplant procedure: Use of carbon dioxide laser versus use of dermabrasion
2. Compare two different dressings in the melanocyte keratinocyte transplant procedure: vaseline impregnated gauze versus collagen dressing

The melanocyte keratinocyte transplant procedure (MKTP) has been shown to be effective in treating vitiligo and other conditions with depigmented skin. MKTP involves the transplantation of melanocytes and keratinocytes from normal skin onto the depigmented skin in order to repigment the skin.

Both dermabrasion and carbon dioxide lasers have been used effectively in MKTP to denude the epithelium. This study will compare the efficacy of these two techniques.

The study will also compare the efficacy of two different dressings used in MKTP, vaseline impregnated gauze and collagen dressings.

Eligibility Criteria:
Inclusion Criteria:

* Depigmented patches of skin

Exclusion Criteria:

* History of Acral Vitiligo
* Unstable Vitiligo, defined as new areas of depigmentation or enlarging areas of depigmentation within the last 6 months
* History of hypertrophic scarring or keloids
* History of koebnerization (new patches of vitiligo at sites of injury or trauma)
Janagliflozin Treat T2DM Monotherapy

The purpose of this study is to assess the effect of Janagliflozin relative to placebo on glycated hemoglobin (HbA1c) after 24 weeks of treatment, and to assess the efficacy after 52 weeks of treatment, overall safety and Population pharmacokinetics.

A multicentre, randomized, double-blind, parallel group, placebo-controlled study(24 weeks core period followed by 28 Weeks Extension period), to evaluate the efficacy and safety of Janagliflozin (25 mg and 50 mg) compared to placebo in patients diagnosed with T2DM who are not achieving an adequate response from diet and exercise to control their diabetes. Approximately 390 patients with inadequate glycemic control with diet and exercise will receive once-daily double-blind treatment with Janagliflozin 25 mg or 50 mg once daily for 52 weeks, or 24 weeks of double-blind treatment with placebo followed by 28 weeks of single-blind treatment with Janagliflozin 25 mg or 50 mg. During the treatment, if a patient's glycemic level remains high despite treatment with study drug and reinforcement with diet and exercise, the patient will receive treatment with metformin (rescue therapy) consistent with local prescribing information. Study drug will be taken orally once daily.

Eligibility Criteria:
Inclusion Criteria:

* All patients must have a diagnosis of T2DM (meet the diagnostic criteria for diabetes issued by the World Health Organization in 1999)
* Patients must have a hemoglobin A1c (HbA1c) level ≥7.5% and ≤11% at screening, and ≥7.0% and ≤10.5% at baseline.
* Drug -naïve (never received anti-diabetic medication or did not receive anti-diabetic medication within 8 weeks before screening).
* Body Mass Index: 18.0\~35.0 kg/m2 (both inclusive)

Exclusion Criteria:

* History of type 1 diabetes mellitus (T1DM), diabetes caused by pancreatic injury, or secondary diabetes (e.g., diabetes caused by Cushing's syndrome or acromegaly)
* More than 10% change in body weight within the 3 months before screening
* Any laboratory test indicators meet the following standards:

  * fasting plasma glucose ≥ 15 mmol/L
  * aspartate aminotransferase, alanine aminotransferase levels \> 3 times the upper limit of normal (ULN); total bilirubin \> 1.5 times ULN
  * hemoglobin \< 100 g/L
  * eGFR \< 60 mL/min/1.73m2
  * fasting triglycerides \> 5.64 mmol/L (500 mg/dL)
Enhancement of Postocclusive Reactive Hyperaemia by Dipyridamole

The purpose of this study is to determine whether dipyridamole enhances postocclusive reactive hyperaemia by increasing extracellular adenosine concentrations during ischemia and reperfusion. Furthermore we hypothesize that dipyridamole augments postocclusive reactive hyperaemia by increasing adenosine receptor stimulation.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers between 18 and 50 years

Exclusion Criteria:

* none specified
Infant Colic Treatment With Probiotics

This study evaluates the efficacy of Bifidobacterium breve CECT7263 and the mixture B. breve CECT7263/Lactobacillus fermentum CECT5716 in the treatment of infant colic. Group 1 will receive B. breve CECT7263 (2x10E8 CFU/day) one dose per day, group 2 will receive B. breve CECT7263 (1x10E8 CFU/day) and L. fermentum CECT5716 (1x10E8 CFU/day) in one dose per day, group 3 (control group) will receive simethicone 20 mg 4 times a day.

Infant colic affects between 3-40% depending on the different criteria used for diagnosis. Recent studies carried out in healthy infants have shown that the consumption of B. breve CECT7263 and L. fermentum CECT5716 during the first months of life are related to a lower risk to present episodes of crying characteristic of infantile colic.

The objective of the present study is to compare the effect of B. brevis and B. brevis\\L mixture. fermentum with respect to simethicone.

It is a multicenter, controlled, randomized, blind, parallel-group, 4-weeks nutritional intervention study which will be conducted in 18 public and private hospitals and health centers from Spain.

Eligibility Criteria:
Inclusion Criteria:

* Infants from 3 to 12 weeks of age
* Born at least at week 34
* Birth weight equal to or greater than 2000 grams
* Fulfill the criteria of Rome III
* Informed consent signed by parents or guardians

Exclusion Criteria:

* Failure to thrive
* Antibiotic treatment less than 2 weeks before the study or during the study
* Take probiotics as a treatment, different from the one that could contain the powdered infant formula
* Abandon breastfeeding and switch to infant formula
* Failure to comply with the study protocol
A Study of GDC-0084 in Patients With Progressive or Recurrent High-Grade Glioma

This open-label, multicenter, Phase I, dose-escalating study will evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and efficacy of GDC-0084 in patients with progressive or recurrent high-grade glioma. Stage 1 is the dose escalation part of the study. Stage 2, patients will receive GDC-0084 at a recommended dose for future studies.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Interval of at least 12 weeks from completion of adjuvant radiotherapy for gliomas to study entry
* Karnofsky Performance Status of \>/= 70 at screening
* Confirmed measurable disease per RANO
* Adequate hematologic and organ function

Patients enrolled in Stage 1:

* Histologically documented recurrent or progressive high-grade gliomas (WHO Grade III-IV)
* Prior treatment with at least one regimen for gliomas (radiotherapy with or without chemotherapy for Grade III gliomas and radiotherapy with chemotherapy for Grade IV gliomas) and/or not considered to be a candidate for regimens known to provide clinical benefit

Patients enrolled in Stage 2:

* Histologically documented recurrent or progressive glioblastoma (WHO Grade IV gliomas)
* Prior treatment with one or two regimens for glioblastoma (with the initial regimen consisting of radiotherapy with chemotherapy)

Exclusion Criteria:

* Treatment with anti-tumor therapy (approved or experimental) within 4 weeks prior to initiation of study drug
* Requirement for anticoagulants such as warfarin or any other warfarin-derivative anticoagulants; low-molecular-weight heparin is permitted
* Any contraindication to MRI examination
* Evidence of Grade \>/= 1 intracranial hemorrhage
* Active congestive heart failure or ventricular arrhythmia requiring medication
* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse or cirrhosis
* Unresolved toxicity from prior therapy with the exception of lymphopenia (for patients with prior temozolomide) and alopecia
* Pregnant or lactating women
Safety of Hormonal Contraceptives Therapies in Polycystic Ovary Syndrome (PCOS) Women

The purpose of this study to assess early markers of cardiovascular disease in women with polycystic ovary syndrome in use of oral contraceptive containing ethynilestradiol and chlormadinone acetate alone or associated with Spironolactone.

Polycystic ovary syndrome (PCOS) is associated with comorbidities that may contribute to increased risk of cardiovascular disease (CVD). Oral contraceptives (OC) have been the mainstay of PCOS pharmacological therapy for decades. However, in non-hyperandrogenic women, OC use is associated with higher risk of cardiovascular disease, raising concern about a possible worsening of the unfavorable metabolic and cardiovascular profile of PCOS patients. There is lack of evidence about the impact of PCOS pharmacological therapies on cardiovascular risk markers and the long-term safety of these drugs in PCOS has not been established. The aim of this study is to compare the effect of an OC alone or associated with an anti-androgenic drug (spironolactone) on echografic cardiovascular risk markers, metabolic and hemostatic variables.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 35 years
* diagnosis of PCOS by Rotterdam Consensus

Exclusion Criteria:

* smoking, alcoholism, drug addiction;
* current pregnancy;
* current or previous use (up to two months before the study) of oral, vaginal, monthly injectable, or transdermal combined hormonal contraceptives;
* current or previous use (up to six months before the study) of a long-lasting hormonal contraceptive method (injectable, implant, or intrauterine device);
* antiandrogenic or hypoglycemic drugs, anti-inflammatory drugs, or statins;
* presence of systemic diseases (DM2, cardiovascular disease, autoimmune diseases, liver disease, thyroid disease, or congenital renal hyperplasia);
* personal history of arterial or venous thrombosis; chronic or acute inflammatory processes;
* puerperium of 12 weeks or less
Study of Chemo-Immunotherapy in Head and Neck Cancer Patients

The purpose of this study is to determine safety and feasibility of Chemo-Immunotherapy using cyclophosphamide, docetaxel, OK-432, and autologous immature dendritic cells for patients with relapsed and refractory head and neck squamous cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. The patients with relapsed and refractory head and neck squamous cell carcinoma
2. 20 years and older
3. ECOG performance status 0-1
4. More than 4 weeks must have elapsed from the time of radiation therapy and the last dose of chemotherapy
5. Tumor lesions are accessible to intratumoral dendritic cells injection
6. Patients who are able to do oral ingestion
7. Patients must have normal organ and marrow functions as follows:

   * Hb\>9.0 mg/dl
   * Ht\>25%
   * WBC\>4000/mm3
   * Platelet count\>100,000/mm3
   * T-Bil\<1.5mg/dl
   * GOT\<x2.5 institutional upper limit of normal
   * GPT\<x2.5 institutional upper limit of normal
   * Creatinin\<1.5mg/dl
8. signed informed consent

Exclusion Criteria:

1. Less than 20 years
2. Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV.
3. Patients with clinically active infection
4. Patients with uncontrolled concurrent illness including cardiovascular disease, pulmonary disease, and bleeding tendency
5. Concomitant malignant diseases, brain metastases
6. Psychiatric illness
7. Treatment with steroids
8. Decision of unsuitableness by physician
Identification to Elimination in HCV-Infected Individuals

Approximately 3.5 - 5 million Americans are living with hepatitis C virus (HCV) in the United States. HCV significantly impacts rural Pennsylvania. It is estimated that 160,000 adults in Pennsylvania are living with hepatitis C. In 2010, Center for Rural Pennsylvania estimated that 27% of population of PA live in one of Pennsylvania's 48 rural counties. Under this estimate, there are over 43,000 individuals affected with chronic HCV living in rural Pennsylvania. Rural county residents often experience barriers to health care by having fewer primary care providers and limited specialty care physicians available to them to address their healthcare needs.

RQ1: Will the community based delivery system for Hepatitis C screenings see an increase in positivity rates?

HO1: There is no relationship between the community based delivery system with an increase in the Hepatitis C screening positivity rates.

HA1: There is a relationship between the community based delivery system with an increase in the Hepatitis C screening positivity rates.

In rural Pennsylvania, transportation is considered a socioeconomic barrier and social detriment to personal health. Using an evidence-based model of population health by bringing the care into the high-risk population's community setting reduces the transportation and socioeconomic barriers of the most vulnerable at risk populations.

It is estimated that 35% to 65% of Opioid Substitution Treatment Patients (OST), are infected with HCV. Therefore, OPT programs that are already operating will be engaged and will be a primary focus for patient screening and recruitment for these services. In addition, high volume venues attracting high-risk populations will also be targeted to encourage HCV screening, education, and treatment.

Primary Objectives:

To screen Opioid Substitution Treatment Patients (OST), high-risk individual at Opioid Treatment Programs (OTP), and/or all high-risk populations in outlying sites (Anti-HCV prevalence)

To initiate HCV treatment of OST patients and other high-risk individuals at OTP facilities and/or high risk populations in outlying sites (linkage of care)

To maintain the successful HCV therapy and cure \[Sustained Viral Response (SVR)\] in OST patients and other high-risk individuals at OPT facility and/or high risk populations in outlying sites (retention)

To facilitate the use of a patient navigator and nursing case management staff to reduce barriers to initial screening and patient education

Eligibility Criteria:
Inclusion Criteria:

Subjects will be included in the study if the following criteria is met:

1. The subject must be an Opioid Substitution Treatment patient.
2. The subject must fall into another high-risk population for the HCV.

Exclusion Criteria:

Subjects may be excluded from the study if the subject falls into an exclusion category as identified as:

1. The subject cannot be or suspected of being pregnant
2. The subject cannot be under the age of 18 years.
3. No subjects requiring a legally authorized representative will be enrolled
Examining the Use of a Novel Immersive Motion Tracking Upper Extremity Exercise Program for Acute Hospitalized Patients

The objective of this study is to evaluate the feasibility of the MoveMend Health software program as an integrated supplement to traditional acute care/in-hospital occupational therapy for patients following liver and kidney transplants, as determined by recruitment rates, program completion, intervention adherence, safety incidence, and patient feedback on device/program performance.


Eligibility Criteria:
Inclusion Criteria:

* English speaking (software program is currently only available in English)
* Status post kidney or liver transplant this admission
* Physician orders for occupational therapy evaluation and treatment
* Orientation Log \> 25
* Negative for delirium per the Confusion Assessment Method

Exclusion Criteria:

* Orthopedic or surgical precautions that limits shoulder range of motion beyond 90 degrees
* Upper extremity hemiplegia with inability to lift upper extremity against gravity
* Accommodation code of Intensive Care Unit
Post-Operative Cognitive Dysfunction in Normal Aging Patients Undergoing Elective Orthopedic Surgery

Post-operative cognitive dysfunction (POCD) is a common concern for aging patients undergoing elective orthopedic surgery and significantly effects health outcomes. This study aims to evaluate the incidence of and risk factors associated with post-operative cognitive dysfunction in aging patients without prior history for mild cognitive impairment or dementia.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥50 and ≤90
* Any patient undergoing elective orthopedic surgery for hip, knee, or shoulder replacement (as defined by diagnostic codes: M16.0, M16.12, M16.11, M17.0, M17.12, M17.11, M19.011, M19.012)

Exclusion Criteria:

* History of cognitive impairment of dementia
* Montreal cognitive assessment (MoCA) \<26
* History of Parkinson's disease, progressive supranuclear palsy, corticobasal degeneration, normal pressure hydrocephalus, Huntington's disease, stroke, seizure disorder, brain tumor, or brain surgery
* History of surgery requiring anesthesia within the past 3 months
Bimetric-10: Investigation of Patients Who Have Underwent Total Hip Arthroplasty With a Cemented Bi-Metric Stem

This is a 10 year follow-up investigation of patients who have underwent total hip arthroplasty with a cemented Bimetric stem.


Eligibility Criteria:
Inclusion criteria:

* Osteoarthrosis

Exclusion criteria:

* Malignancies
Pacemaker and Defibrillator Lead Extraction Registry

Implanted cardiac devices are commonly used to treat a wide variety of heart diseases, including arrhythmias, cardiac resynchronization in select heart failure patients, and life threatening heart rhythms. Approximately 400,000 devices are implanted annually, and more than 3 million patients currently have implanted devices1.

Implanted cardiac devices are made to 2 components, the can and the leads. The can contains the electric circuits and the battery, which must be replaced every 5-10 years. The can is connected to external leads which pass through the subclavian vein, and depending on the device, into the vena cava, right atrium, right ventricle, and/or coronary sinus. Leads typically last longer than the battery, and are simply reconnected to a new can at the time of replacement.

Certain clinical situations necessitate lead removal, including pocket infection, device related endocarditis, venous stenosis or occlusion with the need for new access, and removal of abandoned or malfunctioning leads. Removing the leads is technically difficult due to fibrosis, and requires specialized equipment. Compared to lead implantation, extraction of leads is relatively rare, with a life time risk of a device patient needing an extraction in the 1-5% range. Given that this is a relatively rare procedure and is only done at a few centers, documentation of our experiences with lead extraction can lead to ongoing improvements in both procedural techniques and outcomes.

Study Procedures

This is a retrospective review of data on patient characteristics (such as age, gender, co-morbidities), procedure specifications and indications, and outcomes of lead extraction done at OHSU.

Patients who have undergone either pacemaker or defibrillator lead extraction will have their charts reviewed for the desired data, which will then be compiled into a database. All procedures will be part of routine clinical care.

Data Analysis:

This is an observational registry study; there are no primary or secondary outcomes. Data will be analyzed to determine patient and procedural characteristics, procedure indications, complications and outcomes

Eligibility Criteria:
Inclusion Criteria:

- Undergoing lead extraction

Exclusion Criteria:

* registry--n/a
Randomized Trial of Colonic Stents as a Bridge to Surgery

The objective of this randomized controlled trial was to evaluate the role colonic self-expanding metal stent (SEMS) placement as a bridge to surgery in patients with acute malignant left-sided colonic obstruction. The study was designed to test the hypothesis that SEMS placement could be effectively and safely used in this group of patients to relieve colonic obstruction thereby allowing safe recovery and medical stabilization before proceeding to elective surgery


Eligibility Criteria:
Inclusion Criteria:

* Acute intestinal obstruction secondary to left-sided colonic cancer

Exclusion Criteria:

* Distal rectal cancers
* Patients with signs of peritonitis suggestive of bowel perforation