cyrilzakka/clinical-trials huggingface dataset:
Intermediate-Size Expanded Access Protocol (EAP) for LP352

This is an intermediate-size expanded access program (EAP) study. The purpose of this EAP is to provide continued access to LP352, an investigational drug product being investigated in participants with DEEs. The EAP study will allow continued treatment with LP352 for eligible participants diagnosed with treatment resistant DEEs who successfully completed an LP352 Clinical Trial (Enrollment by Invitation) or an immediate family member who has the exact same gene mutation resulting in the same DEE epilepsy syndrome phenotype or a patient who previously participated in the lorcaserin EAP.


Eligibility Criteria:
Inclusion Criteria:

1. Participant and/or participant's legally authorized representative is willing and able to provide a written informed consent or assent form before participation in this EAP. An assent should be obtained from the patient, if possible. Assent must be obtained for adolescent EAP patients (\<18 years of age) as required by local regulations.
2. Participant with DEE who has successfully completed an LP352 Clinical Trial.
3. Participant currently has clinical benefit from LP352 treatment, as assessed by their Treating Physician.
4. Participant currently tolerates LP352 treatment and has no safety issue which would prevent continued treatment.

Exclusion Criteria:

1. Participant was discontinued from an LP352 Clinical Trial for any reason.
2. Any serious and/or unstable new medical condition, psychiatric disorder, or other conditions at the time of transition to this EAP that could interfere with patient's safety, obtaining informed consent, assent, or compliance to this EAP protocol, in the opinion of the Treating Physician.
Individual Patient Data Analysis of Viabahn for Peripheral Arterial Disease

To evaluate the effectiveness of the VSX device in pre-determined patient populations to understand the patient characteristics that impact outcomes.

Rationale: Studies on the efficacy of self-expanding covered stents for the treatment of patients with superficial femoral artery (SFA) occlusive disease have mainly focused on stent patency. Subgroup analysis was often not feasible, related to small sample sizes. This pooled analysis of individual patient-level data provides larger sample sizes and a more heterogeneous population, which allows for the ability to perform subgroup analyses to identify patients that will most benefit from VSX treatment. The current analysis will provide insights into the effectiveness of the VSX device for specific subgroups.

Objective: To evaluate the effectiveness of the VSX device in pre-determined patient populations to understand the patient characteristics that impact outcomes.

Study design: Multicenter retrospective individual patient data meta-analysis. Study population: Patients treated with a VSX device for de novo or restenotic lesions of the superficial femoral artery and previously enrolled in a prospective VSX study whom were treated for SFA disease with the latest generation heparin-bonded Viabahn, and published in peer reviewed journals.

Main study parameters/endpoints: The primary study parameter is primary patency at 12-months. In addition, for all subjects and for subgroups as described further below, the following secondary endpoints will be evaluated through follow-up: primary patency at 24 months, primary assisted patency, secondary patency, freedom from Target Lesion Revascularization (TLR) at 12 and 24 months, clinical Improvement, minor and major amputation, mortality. The following subgroup analysis will be performed if sufficient data are available: critical limb threatening ischemia patients (Rutherford 4-6), patients with intermittent claudication (Rutherford 1-3), chronic total occlusions, by gender, by number of runoff vessels, lesion length, TASC II lesion classification, calcified lesions, by device diameter.

Eligibility Criteria:
Inclusion Criteria:

1. Patient was enrolled and treated with the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface device in a Gore-sponsored or physician-sponsored study for de novo or restenotic lesions of the femoropopliteal artery.
2. Lesions ≥10 cm in length and TASC C or D classification will be included
3. Patient-level data can be obtained and pooled with other studies

Exclusion Criteria:

1. Patient was not formally enrolled in their corresponding study (e.g., training cases)
2. Patient was enrolled for treatment of in-stent restenotic lesions.
3. Patient has incomplete or missing data that does not allow for analysis.
4. Case reports (n\<10 patients)
Effects of a Longitudinal Health Literacy Training Program on Family Medicine Residents

1. Briefly describe the purpose of this protocol: This study is designed to evaluate the effectiveness of an educational training program on the topic of health literacy for Family Medicine residents. The hypothesis being tested is that training residents about health literacy will result in improvements in residents' knowledge, skills, and attitudes with respect to health literacy.
2. Briefly summarize how participants are recruited: OHSU Family Medicine Interns attending mandatory trainings on the topic of health literacy throughout the three years of the residency program will be invited to participate in the study.
3. Briefly describe the procedures subjects will undergo: Completion of a short self-administered anonymous survey before and after a variety of learning sessions on the topic of health literacy.
4. If applicable, briefly describe survey/interview instruments used: A 12-item pre-test questionnaire and 13-item post-test questionnaire designed to assess individuals' knowledge about health literacy, and intended clinical practices with respect to health literacy.
5. If this is a clinical trial using an experimental drug and/or device, or an approved drug and/or device used for an unapproved purpose, briefly describe the drug and/or device: n/a
6. Briefly describe how the data will be analyzed to address the purpose of the protocol: Demographics and responses to individual items will be reported as frequencies and percentages within the sample. We will use a chi-square analysis to stratify responses by demographic groups and t-tests to measure possible changes over time


Eligibility Criteria:
Inclusion Criteria:

-Family medicine resident entering in summer 2011 at OHSU Department of Family Medicine
The CASCADE HF Soft Launch and Calibration Phase I and II

Invasive telemonitoring has shown promising results in reducing readmissions and health service utilization, and improving patient outcomes; however, such evidence is lacking for non-invasive telemonitoring. Our proposal is to deploy a wearable solution that predicts physiological perturbation comparable to invasive devices and to perform continuous remote patient monitoring; this will be connected to a structured, cascading, escalation pathway involving home health nurses, advanced practitioner providers, specialists, and surgeons, and has the potential to transform care management in the post-discharge period, where patients are the most vulnerable for readmission.


Eligibility Criteria:
Inclusion Criteria:

* Patient is an inpatient at NorthShore University HealthSystem
* Patient is on the heart failure consult list
* Patient has a history of heart failure
* Patient received at least one dose of IV diuretics at index hospitalization
* Patient is discharging with NorthShore Home Health services
* Symptoms corresponding to New York Heart Association function class II-IV
* Patient has heart failure with reduced left ventricular ejection fraction (LVEF)\<40%, or HF with mid-ranged ejection fraction (LVEF 40-50%), or HF with preserved ejection fraction (LVEF≥50%)
* Patient is in the top 50% risk of readmission across NorthShore University HealthSystem's CAPE 30-day readmission model
* Patient is at least 18 years of age
* Patient is fluent in English
* Patient agrees to protocol-required procedures

Exclusion Criteria:

* Patient has cognitive or physical limitations that, in the opinion of the investigator, limit the patient's ability to maintain patch, phone
* Patient has allergy to hydrocolloid adhesives
* Patient has present skin damage preventing them from wearing a study device
* Patient has renal dysfunction requiring dialysis
* Pregnancy
Prehabilitation Exercise Program in Breast Cancer: Effects on Quality of Life and Tumor Microenvironment (PEP_BC)

To improve the health and quality of life of breast cancer (BC) patients, researchers are focusing on prehabilitation strategies like physical exercise, preparing patients both mentally and physically for clinical and surgical procedures, potentially reducing complications. Physical exercise is also recognized as pivotal in optimizing chemotherapy. It can improve blood flow and oxygen supply in the microenvironment of the tumor (MT), potentially enhancing chemotherapy effectiveness. Although previous research has shown the benefits of preoperative exercise combined with chemotherapy in various cancer types, including BC, further investigation is needed into the exact effects of prehabilitation exercise (PE) on MT physiology.

This study aims to provide valuable insights into the potential benefits of PE for BC patients and its impact on the tumor microenvironment. The hypothesis is that PE in BC patients will improve their quality of life, reduce fatigue, increase muscle mass, decrease fat mass, and enhance physical fitness. Additionally, beneficial acute hemodynamic changes, particularly increased blood flow following PE sessions, and hemodynamic adaptations involving higher levels of oxygenated hemoglobin, increased blood flow, greater oxygen saturation, and a higher metabolic rate of oxygen, are expected.

The study will include 76 participants aged 18-65 years, meeting specific criteria such as a diagnosis of hormone receptor-positive BC, no medical contraindications for exercise, no metastatic cancer, and no structured exercise in the last six months. These participants will be randomly assigned to a PE group or a control group. The study will consist of three phases: Phase 1 involves pre-intervention assessments, Phase 2 includes a 4-week PE intervention with three weekly sessions, and Phase 3 encompasses post-intervention and post-surgery assessments. The 4-week PE intervention in Phase 2 will include strength and aerobic training. Quality of life and fatigue assessments will use questionnaires, and measurements will be made for fat mass, lean mass, bone density, and cardiorespiratory fitness. Strength measurements will be taken, and shoulder mobility will be evaluated. Hemodynamics of the MT will be assessed using a hybrid device combining Near-Infrared Spectroscopy and Diffuse Correlation Spectroscopy with ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* Be aged between 18 and 65 years.
* Have a diagnosis of hormone receptor-positive breast cancer (ER and PR).
* Have no medical contraindications that prevent them from participating in physical exercise.
* Have four weeks period between diagnosis and surgery

Exclusion Criteria:

* Being diagnosed of another primary and/or secondary tumor or being in metastatic stage.
* Presence of uncontrolled serious medical illness
* Presence of any medical, psychological or social problem that could seriously interfere with the patient's participation in the study
* Those who have engaged in structured physical exercise in the last 6 months.
Incidence and Clinical Progression of Asymptomatic PICC-Related Thrombosis in Solid Cancer Patients

In this prospective cohort study, the investigators evaluated the incidence of superficial vein thrombosis, deep vein thrombosis, and fibroblastic sleeve formation in solid cancer patients undergoing chemotherapy. The study aimed to shed light on the clinical progression of venous thrombosis in cancer patients with central venous catheters, with a particular focus on certain cancer types associated with a higher risk of venous thromboembolism (VTE).

The investigators believe that such findings hold significant clinical relevance as a substantial portion of the study population was affected by pancreatic cancer, a cancer type known to carry a high risk of thrombotic events. This research adds valuable insights into understanding asymptomatic PICC-related thrombosis in this specific subgroup of cancer patients, which can aid in developing effective management strategies for venous access in this challenging population.

The study employed an ultrasound-guided approach for follow-up at 30 and 90 days after catheter insertion, enabling us to detect and treat asymptomatic PICC-VTE in a timely manner. Identifying independent risk factors for catheter-related thrombosis, including age and cancer type, has further enhanced the clinical applicability of our findings.

Managing venous access in cancer patients is challenging, and peripherally inserted central catheter-ports (PICC-ports) have emerged as a promising option for safety and efficacy. However, understanding the clinical progression of venous thrombosis in cancer patients with central venous catheters remains limited, especially in certain cancer types associated with a higher risk of venous thromboembolism (VTE).

In this prospective cohort study of solid cancer patients receiving chemotherapy, the investigators will evaluate the incidence of superficial vein thrombosis, deep vein thrombosis, and fibroblastic sleeve formation through ultrasound follow-up at 30 and 90 days after catheter insertion. The investigators will analyze clinical factors associated with PICC-related VTE (PICC-VTE) and compare incidence rates between PICC-ports and traditional PICCs.

Ultrasound follow-up is valuable for detecting asymptomatic PICC-VTE, enabling timely and effective initiation of therapy, especially in elderly patients and those with high-risk thrombotic cancers.

Eligibility Criteria:
Inclusion Criteria:

* patients with:

  1. a documented active malignancy;
  2. PICC or PORT placement for systemic chemotherapy;

Exclusion Criteria:

* patients with:

  1. a communication disorder;
  2. contraindications to anticoagulation therapy;
  3. hematopathy;
  4. expected survival of less than one month;
  5. were lost to follow-up.
Phase III Cat-PAD Study

The purpose of this study is to compare the treatment effect of two treatment regimens of Cat-PAD vs placebo and to evaluates the treatment effect of Cat-PAD on symptoms, rescue medication usage and Quality of Life.


Eligibility Criteria:
Inclusion Criteria

* Male or female, aged 12-65 years.
* Moderate to severe rhinoconjunctivitis on exposure to cats for at least 2 years.
* Subjects may optionally also have GINA Step 1 controlled asthma.
* Positive skin prick test to cat hair.
* Cat dander specific IgE ≥0.35 kU/L.

Exclusion Criteria

* Asthma falling under the GINA definitions "partly controlled" and "uncontrolled" or Steps 2 to 5.
* FEV1 \<80% of predicted.
* Clinically significant confounding symptoms of allergy to seasonal allergens during the final evaluation period.
* Skin prick test 5 mm greater than the negative control to perennial allergens or animal dander (other than cat) which cannot be avoided during the study.
* Significant symptoms of another clinically relevant illness that is likely to affect scoring of rhinoconjunctivitis symptoms.
* Clinically relevant abnormalities detected on physical examination.
* History of severe drug allergy, severe angioedema or anaphylactic reaction to food.
11C-choline PET/CT Based Helical Tomotherapy as Innovative Treratment Approach for Bone Metastases in Prostate Cancer Patients.

The number of metastases may reflect the biological aggressiveness of the tumor and may determine the possibility of performing potential curative interventions such as surgery or high-dose targeted radiotherapy (RT). Until a few years ago, the treatment of choice for metastatic prostate cancer was androgen deprivation (TDA). This treatment was carried out as palliative care in order to postpone the progression of the disease or reduce symptoms. Patients with prostate cancer with a limited number of metastases, similarly to patients suffering from other solid tumors, can be considered as patients with disease that has limited capacity to cause further secondary effects. In this scenario, the primary treatment in patients with carcinoma localized prostate, is characterized by radical prostatectomy, followed by measurement of prostate specific antigen (PSA) during follow-up. After primary prostatectomy, PSA values \> 0.2 ng/mL are indicative of disease recurrence, but it is not possible to determine whether the recurrence is local or distant. Furthermore, imaging modalities, such as bone scanning and computed tomography (CT), do not have sufficient sensitivity to detect the presence of metastatic disease in patients with low PSA levels. Positron emission tomography/CT with 11C-choline is able to detect local or distant metastases with a sensitivity and specificity greater than 85% in patients with biochemical disease recurrence. 11C-Choline PET/CT can be a valid tool both for diagnosis and for guiding radiotherapy treatments in these patients for whom it is not possible to obtain a definitive diagnosis with conventional diagnostic procedures. There are currently few studies that have described the use of 11C-choline PET/CT to guide treatment for bone metastases; the limitations of these studies concern the small number of patients and the short follow-up. The aim of this retrospective observational study was to evaluate the efficacy of 11C-choline PET/CT as a guide to the treatment of helical tomotherapy for an innovative therapeutic approach in bone metastases in a population of patients affected by prostate cancer with a limited number of metastasis.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with less than 3 bone lesions found on C11-Choline PET/CT
* availability of clinical follow-up using serial PSA assays.

Exclusion Criteria:

\<18 years patients
Effects of Forest Therapy on Physical and Psychological Parameters in the General Population - a Randomized Controlled Trial

In recent years, nature and forest therapy has increasingly become the focus of medical research. Recent scientific findings indicate overall positive effects of nature and forest therapy on physical and mental health. In Asia and Australia, it has already been implemented as a public health concept of prevention and health promotion. The aim of the project is to replicate the experience gained in Asia over the last three decades on the physical and psychological effects of nature/forest therapy in the context of the German forest and to investigate it further scientifically.


Eligibility Criteria:
Inclusion Criteria:

- Ability to Consent

Exclusion Criteria:

* Serious acute or chronic illness
* Immobility or limitation of mobility due to orthopedic, neurologic, or other medical causes
* Participation in another study
* Serious mental illness
* Pregnancy and lactation.
TBR-760 in Adult Patients With Non-Functioning Pituitary Adenomas

This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, efficacy, PK, and PD of the chimeric dopamine-somatostatin receptor agonist, TBR-760, in adult patients with NFPA over 52 weeks.

This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, efficacy, PK, and PD of the chimeric dopamine-somatostatin receptor agonist, TBR-760, in adult patients with NFPA over 52 weeks. Approximately 150 patients will be enrolled.

Eligibility Criteria:
Key Inclusion Criteria:

* Confirmed diagnosis of NFPA (defined as lack of clinical and biochemical evidence of adenohypophyseal hormone excess), and be status-post one TSS with a NFPA remnant of ≥ 10mm (maximum diameter)
* Study subjects must be capable of giving informed consent and reading and signing the informed consent form after the nature of the study has been fully explained by the Investigator or Investigator designee
* Study subject must be willing and able to complete all study assessments and procedures and to communicate effectively with the Investigator and site staff.

Key Exclusion Criteria:

* Has undergone more than one TSS, or had TSS \<6 months prior to screening, or is anticipated to require TSS within 6 months of Screening
* Has undergone radiation therapy to the head for any reason, or is already planned to have or anticipated to require radiation therapy during the study period;
* Has any contraindications to magnetic resonance imaging including allergy or intolerance to gadolinium or gadolinium-based contrast;
* In the opinion of the Investigator, the patient is unable to meet the requirements of the study.
Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD)

The purpose of this study is to assess the efficacy, safety and pharmacokinetics after administration of 10mg/kg TA-650 every 8 weeks to patients with Crohn's disease showing an insufficient response to previous treatment with 5 mg/kg of REMICADE every 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Crohn's disease
* Patients who have relapsed with symptoms associated with Crohn's disease within 8 weeks in spite of maintenance treatment with 5mg/kg REMICADE every 8 weeks, and who are judged to be showing an insufficient response to the previous treatment by their physician

Exclusion Criteria:

* Severe intestinal strictures (which may have an effect on the number of loose stools or diarrhea or dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy), a diagnosis of short bowel syndrome, or previous stoma surgery
* The presence of significant internal fistula (possibility that surgery might be needed, etc.) is confirmed
* A history of a serious infusion reaction to REMICADE
* Pregnant, lactating, and probably pregnant women
* Patients who have participated in other trials and have been administered other investigational products within 12 weeks before consent
* Patients judged to be inadequate to participate in this study by their physician
Effect of Visceral Osteopathic Manipulations on Low Back Pain

Forty female patients with age ranging from 30-40 years old were suffering from low back pain due to visceral dysfunctions participated in this study. They were recruited from a private clinic. They were assigned into two groups equal in number; Group (A): included twenty patients who received osteopathic manipulative techniques, 1 session per week for 3 weeks, and Group (B): included twenty patients who received only analgesic drugs.

Twenty patients received osteopathic manipulative techniques including Suboccipital release technique, diaphragmatic release.,mesentery release and Colonic manipulation were applied to the study group according to the patients' needs.

The treatment program comprised a total of 3 sessions for 3 weeks at one session per week for an average of 50 minutes per session. Twenty patients in the second group (control ) took only analgesics during the three weeks.

Eligibility Criteria:
Inclusion Criteria:

* Non-specific low back pain for more than 12 weeks

Exclusion Criteria:

* Malignant tumor
* Pregnancy
* Acute ischemic bowel disease,
* Intestinal obstruction,
* surgery in the last six months