cyrilzakka/clinical-trials huggingface dataset:
Palliative Care in Improving Quality of Life in Patients With Newly Diagnosed Pancreatic Cancer

This pilot clinical trial studies a palliative care program in improving the quality of life of patients with newly diagnosed pancreatic cancer. Palliative care is care given to patients who have a serious or life-threatening disease, and focuses on managing disease symptoms, side effects of treatment or the disease, and improving patient quality of life. Studying a palliative care program used for other types of cancer may help doctors learn whether it can improve the quality of life of patients with pancreatic cancer.

PRIMARY OBJECTIVES:

I. To pilot-test an interdisciplinary Palliative Care Planning Intervention (PCPI) in pancreatic cancer. Specifically, to describe patients' satisfaction with the timing, content, and delivery of the PCPI intervention.

SECONDARY OBJECTIVES:

I. To pilot-test all selected measures for the study, including measures for healthcare resource utilization, overall cost, and patient/family out of pocket expenses.

II. The long-term objective of this pilot study is to conduct a larger PCPI intervention study for pancreatic cancer patients and evaluate its impact on quality of life (QOL), symptom intensity, healthcare resource utilization, and healthcare costs.

OUTLINE:

Patients receive a handbook titled "Supporting You During Cancer Treatment" with educational material on QOL issues. Patients undergo 2 education sessions on handbook material in-person or by telephone, with session 1 focusing on physical and social well-being issues and session 2 focusing on psychological and spiritual well-being issues. At the beginning of each session, patients select 3 priority topics from a list, and content is tailored to patient needs.

After completion of study, patients are followed up at 1 and 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed, new diagnosis of borderline resectable, locally advanced resectable/unresectable, or metastatic pancreatic cancer
* Patients who are scheduled to receive treatments (neoadjuvant therapy, surgery, adjuvant therapy, or palliative chemotherapy) at City of Hope (COH)
* All subjects must have the ability to understand and the willingness to provide informed consent

Exclusion Criteria:

* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
A Feasibility Study of Multimodal Exercise/Nutrition/Anti-inflammatory Treatment for Cachexia - the Pre-MENAC Study

A multicentre, open, randomized phase II study comparing a multimodal intervention (oral nutritional supplements, celecoxib and physical exercise) for cachexia versus standard cancer care.


Eligibility Criteria:
Main eligibility criteria:

* Advanced non-small-cell lung cancer (stage III-IV) or pancreatic cancer not eligible for curative therapy
* Due to commence chemo- or chemo radiotherapy
* Karnofsky Performance Score ≥ 70
* A life expectancy of ≥4 months and considered able to complete 2 months of the study
Abbreviated Breast MRI (AB-MRI) With Golden-angle Radial Compressed-sensing and Parallel Imaging (GRASP)

The purpose of this study is to use a magnetic resonance imaging (MRI) sequence called golden-angle radial compressed sensing and parallel imaging (GRASP) as a noninvasive and fast way to measure the wash-in contrast (dye) in the breast. MRI uses a strong magnetic field and radio waves to create images of structures in the body. The goal is to determine if benign and malignant breast lesions have different patterns of contrast wash in.

This study will ask woman planning to undergo a clinical breast MRI with contrast (dye) as part of their standard care.


Eligibility Criteria:
Inclusion Criteria:

* No contraindications to MRI scanning (pacemaker, implanted metallic objects, severe obesity or other condition that leads to difficulty lying in the magnet)
* Able and willing to provide informed consent

Exclusion Criteria:

* Currently undergoing neoadjuvant chemotherapy for breast cancer treatment.
Atrophic Gastritis and OLGIM Stage

Three clinical research coordinators recruited patients aged 40-75 who underwent screening endoscopy at the Digestive Endoscopy Center of Qilu Hospital from July 1, 2022, to July 30, 2024. All participating patients provided written informed consent. Baseline information such as height, weight, age, sex, smoking and alcohol consumption status, HP status, and family history of gastrointestinal tumors were recorded before endoscopy. During endoscopy, the endoscopist observed and photographed the lesser and greater curvature of the antrum, corpus, and incisura, performed the Kimura-Takemoto classification, and classified those with a Kimura-Takemoto score of C0 as non-atrophic gastritis and those with C1-O3 as atrophic gastritis. Patients with atrophic gastritis received free multiple-site biopsies for pathological assessment, including targeted biopsies of suspected IM areas and random biopsies from Sydney classification sites. At least four biopsies were taken from the lesser and greater curvature of the antrum and corpus for pathological evaluation, and OLGIM staging was calculated based on the results.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria were patients aged 40-75 undergoing painless screening endoscopy

Exclusion Criteria:

1) previous gastric surgery; 2) inability to undergo biopsy due to anticoagulant use; 3) refusal to sign informed consent; 4) history of radiotherapy or chemotherapy; 5) new diagnosis of advanced gastric cancer during endoscopy; 6) failure to complete multiple-site biopsy for atrophic gastritis; and 7) diagnosis of non-atrophic gastritis during endoscopy.
Guided Internet-based Interventions in Primary Care Effectiveness-implementation Randomized Controlled Trial

Internet-based cognitive behavioral therapy for anxiety and depression have far-reaching potential to overcome common barriers to accessing evidence-based treatment, such as waiting lists, travel distance and costs. Despite the undeniable promise of iCBT, several aspects remain poorly understood and warrants further study.

The INTERMENTAL project is a joint effort between Norwegian Institute of Public Health, Norwegian Directorate of Health and six Prompt Mental Health Care (PMHC) services, situated in 11 municipalities, to evaluate the iCBT interventions developed by the technology company "Assistert Selvhjelp" (AS-iCBT). We will conduct a large-scale hybrid effectiveness-implementation randomized controlled non-inferiority trial that will provide new knowledge on the effectiveness, cost-effectiveness and implementation of AS-iCBT in primary care.

Primary objective: Examine the non-inferiority of guided internet-based cognitive behavioural treatment "Assistert Selvhjelp" (AS-iCBT) compared to treatment as usual in the primary care service Prompt Mental Health Care (TAU-PMHC) with regard to effects on symptoms of anxiety and depression.

Secondary objectives: (i) Examine the non-inferiority of AS-iCBT compared to TAU-PMHC on other outcomes such as quality of life, functional level, specific anxiety measures (social anxiety, panic disorder), sleep and employment status; (ii) Examine the cost-effectiveness of AS-iCBT compared to TAU-PMHC; (iii) Examine to what extent moderators and mediators of change are associated with treatment effectiveness of AS-iCBT; (iv) Assess whether AS-iCBT is as acceptable and appropriate for treatment of anxiety and depression as TAU-PMHC, and examine barriers/facilitators for their further implementation.


Eligibility Criteria:
Inclusion Criteria:

* Presence of anxiety and/or mild to moderate depression.
* Being above 18 years of age and a resident in the pilot sites.
* Basic verbal and oral Norwegian proficiency.
* Having internet access and ability to use it.

Exclusion Criteria:

* Entitled to secondary care services due to eating disorder, suicide risk, bipolar disorder, severe depression, psychotic symptoms, severe substance abuse, and/or personality disorder.
* Two or more previous treatment attempts in secondary care services without effect.
* Serious physical health problem as primary problem.
* Clients that have had treatment at PMHC before and only require a booster session.
Delayed Educational Reminders in Acute Myocardial Infarction (MI)

ST segment elevation myocardial infarction (STEMI) is a common presentation of heart attack constituting approximately 30% of all cases. Clinical guidelines around the world support the prolonged use of secondary preventative medications including aspirin, clopidogrel, statin, beta-blocker and angiotensin blockers with the highest recommendations. While in-hospital and discharge prescription rates are excellent, adherence to these essential life-saving medications is far less than ideal, even a few months following hospital discharge. The investigators plan to capitalize on the existing structure of the SMART-AMI project already underway in LHIN IV to undertake a randomized controlled trial evaluating a reminder sent on behalf of the interventional cardiologists, delivered by mail, at 1, 2, 5, 8, and 11-months post-discharge, reviewing the evidence for life-saving cardiac medications and urging long-term adherence to secondary preventative cardiac medications. This will be sent to the family physician and the patient, using audience-appropriate language. If the DERLA-STEMI project is accepted by physicians and patients, found to be both feasible and effective, then this simple and low-cost intervention will be studied in all patients with an abnormal coronary angiogram.


Eligibility Criteria:
Inclusion Criteria:

* Admitted with STEMI to a hospital in LHIN IV, coronary angiogram with and without PCI at Hamilton General Hospital during hospital admission

Exclusion Criteria:

* Non-english speaking
Study To Determine The Effects Of Doses Of Relacatib On The Metabolism Of Acetaminophen, Ibuprofen And Atorvastatin

Relacatib is being developed for the treatment of osteoporosis, osteoarthritis and possibly other bone disorders. Recent results suggest that relacatib interacts with the way our bodies metabolise drugs and so some drugs which are commonly prescribed to the intended target patient population could be affected by giving relacatib at the same time. The purpose of this study is to evaluate the effect of repeat dose administration of relacatib on the way subjects bodies metabolise three commonly prescribed medications in the osteoarthritis population: ibuprofen, acetaminophen, and atorvastatin.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Postmenopausal
* Body weight \> 50 kg
* Body mass index (BMI) between 19 and 30
* The subject is willing and able to give a signed and dated written informed consent prior to admission to the study
* The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

Exclusion Criteria:

* Subjects with known morphea or sclerodermia
* Subjects with a history of myocardial infarction.
* Subjects with a history of renal/or hepatic disease unless the disease has been successfully treated and is no longer active; subjects with any evidence of renal/ or hepatic impairment on the screening physical and laboratory examination.
* Subjects with history of hypertension or systolic blood pressure
* Subjects with history of diabetes
* History of regular alcohol consumption exceeding 7 drinks/week (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
* History of use of tobacco- or nicotine-containing products within 6 months of screening, or a positive urine cotinine indicative of smoking at screening.
* Positive urine drug screen including alcohol (or alcohol breath test) at screening.
* Positive for HIV, hepatitis B virus or hepatitis C virus.
* Donation of blood in excess of 500 mL within 56 days prior to dosing
* History of sensitivity or contraindications to any of the study medications (i.e., relacatib, paracetamol, ibuprofen or atorvastatin) or components thereof.
* Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
* Subjects whom are judged by the investigator to be at risk for acute angle closure glaucoma.
Non-invasive Neuromodulation NESA Application in the Rehabilitation of Stroke Sequelae

To evaluate whether NESA microcurrents can be used as an effective treatment for various sequelae present in stroke patients, specifically in the treatment of spasticity, balance, pain; and whether it affects quality of life, performance of activities of daily living and quality of sleep.

Pilot study following a randomized controlled trial design, designed to study the feasibility of a study with a larger sample size.

Intervention of 30 stroke participants with an evolution between 6 months and 4 years since the stroke, who are able to stand upright.

These participants will be recruited voluntarily through a campaign in social networks and with the collaboration of local associations and institutions. Once the inclusion and exclusion criteria have been reviewed, they will be randomly assigned to an intervention group and a placebo group. A double-blind recruitment system will be followed in which the physiotherapist and patients will not know whether they are receiving real or simulated stimulation, for this purpose two NESA XSIGNAL® devices will be used in double-blind mode.

Treatment of 20 sessions per patient, of 1 hour duration each, with the NESA X-Signal device.

Eligibility Criteria:
Inclusion Criteria:

* People who have suffered a stroke with an evolution between 6 months and 6 years.
* Optimal cognitive capacity and mentally competent to participate in the study and complete the required questionnaires.
* People able of standing upright, including those who need technical aids.

Exclusion Criteria:

* Present some of the contraindications for a treatment with NESA XSIGNAL®: pacemakers, internal bleeding, not to apply electrodes on skin in bad condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and/or phobia to electricity.
* Not having signed the informed consent form.
* Presenting any additional injury or pathology during the study.
* Not having the optimal cognitive capacities for understanding and participating in the study.
MEdical Versus SUrgical Treatments of Rectal Endometriosis

The purpose of this study is to determine whether, in women with deep endometriosis involving the rectum and not intending to get pregnant, continuous hormonal treatment would be followed by better digestive functional outcomes than curative rectal surgery. Are included women from 35 to 50 years presenting with deep endometriosis infiltrating at least the muscular layer of the rectum and not having pregnancy intention.

The main outcome concerns the quality of digestive function 24 after the onset of the treatment, assessed using a composite variable: patient considering that digestive function is normal AND the Knowles-Eccersley-Scott-Symptom Questionnaire (KESS score) \<7 AND the Gastrointestinal Quality of Life Index (GIQLI) score \>100.

Secondary outcomes are: presence of severe constipation, increased frequency of daily bowel movements, anal incontinence, postoperative dysuria, Biberoglou \& Behrman score, quality of life SF36 score, KESS score, GIQLI, Wexner score of anal continence, Bristol stools score, the rate of postoperative complications, medical treatment adverse outcomes, the rate of additional endoscopic and surgical procedures.

The randomization is central, once the physician asses the diagnosis, explain the study's principle and rece In the arm A, the patients received triptoreline and add back therapy by estradiol during 6 months, followed by daily intake of cyproterone acetate and add back therapy during 18 months.

In the arm B, patients are managed by rectal surgery (depending on the surgeon choice: rectal shaving, rectal disc excision or colorectal resection) followed by the prevention of recurrences by daily intake of cyproterone acetate and add back therapy during 18 months.

The number of subjects required is 78 (39 on each arm). Inclusions period is estimated at 24 months. The length of the follow up is 24 months. The patients have 8 visits in the arm A, and 7 visits in the arm B.

Eleven French tertiary referral centres will enrol patients in the trial.


Eligibility Criteria:
Inclusion Criteria:

* Age 35-50
* No menopause
* Digestive complaints: defecation pain, dyskesia, diarrhea, constipation, rectorrhage
* Imaging assessment revealing deep endometriosis involving at least the muscular rectal layer
* No intention to get pregnant during the following 24 months
* Negative urinary pregnancy test
* Affiliated to the French Social Security System

Exclusion Criteria:

* Pregnant women or during the breastfeeding
* Pregnancy intention or lack of efficient contraception
* Unexpected rectal endometriosis intraoperatively revealed
* Refus of one of treatments planned in the two arms
* Severe disease requiring surgical treatment in emergency (bowel occlusion, ureteral stenosis or hydronephrosis), severe dyspareunia
* Contraindications to hormonal treatment or surgery
* Major thromboembolic factors
* Antecedents of inflammatory bowel diseases, cancer or colorectal resection
* Vaginal hemorrhage with undetermined etiology
Ventilatory Constraint, Breathing Pattern and Ventilatory Responses in Obese Postmenopausal Women

The purpose of this study was to examine the dynamic lung volumes in obese post-menopausal women (without hormone replacement therapy) during exercise and their correlations with dyspnea.

Obesity-related changes in lung volumes have shown to affect breathing mechanisms. During exercise, altered breathing mechanisms increase potential for expiratory flow limitation and compromise exercise capacity. Estrogen and progesterone are potent respiratory stimulants, and their effects in the physiologic regulation of breathing are down-regulated after menopause. Therefore, we theorized that the combined obesity and reduced sex hormone levels after menopause work as a double jeopardy to cause mechanical ventilatory constraint which aggravates dyspnea sensation during exercise, and thus a reduction in exercise capacity. The purpose of this study was to exam the dynamic lung volumes in obese post-menopausal women (without hormone replacement therapy) during exercise and their correlations with dyspnea.

From doctoral referral and advertisement, 24 obese (BMI ≧ 27 kg/m2) and 26 lean post-menopausal women were recruited for the study. Pulmonary function and body composition were measured at rest. A maximal flow volume loop (MFVL) was obtained at baseline. All subjects then performed an incremental exercise test on a cycle ergometer with workload increasing 25 watts every 3 min. During exercise, at each workload, the tidal exercise FV loops were obtained and an inspiratory capacity (IC) maneuver was conducted to assess changes in end-expiratory lung volume (EELV) and end inspiratory lung volume (EILV). Dyspnea and leg fatigue were assessed using the Borg scale. Analysis of variance with repeated measurements was used to test the significance of the mean differences between the two groups during exercise. Linear regression analysis was used to determine whether changes in dynamic lung volumes during exercise were related to changes in Borg scores. Statistical significance was established at p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women (for at least 1 year)
* Age below 69 y/o
* Not receiving hormone replacement therapy

Exclusion Criteria:

* Cardiopulmonary disease
* Musculoskeletal disease affecting results of maximal exercise test
A Pilot Study of MabThera (Rituximab) Evaluated by MRI in Patients With Rheumatoid Arthritis.

This single arm study will measure the effect of MabThera in combination with methotrexate on the progression of synovitis, the extent of bone marrow edema, and the number of erosions in the wrist and hand of patients with rheumatoid arthritis, using a new MRI technique. Patients will receive MabThera 1000mg i.v. on days 1 and 15, in combination with a stable dosage of 10-25mg/week methotrexate throughout the duration of the study. Further courses of MabThera will be provided to eligible patients. MRI will be performed 1-2 weeks before treatment initiation, and repeated 1 and 6 months after the first MabThera infusion. The anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age;
* rheumatoid arthritis for \>=3 months and \<=10 years;
* inadequate response to methotrexate (12.5-25mg/week) for \>=3 months;
* evidence of erosive disease and/or clinical synovitis in a signal joint.

Exclusion Criteria:

* autoimmune rheumatic diseases other than RA;
* surgical operations on bones/joints in 12 weeks prior to baseline visit;
* concomitant treatment with biologic agents;
* previous treatment with more than one biologic agent approved for RA, or with cell-depleting therapies.
Combination Chemotherapy and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia (CLL) That Did Not Respond to Fludarabine, CLL With Autoimmune Haemolytic Anemia (AIHA) or Richter's Transformation (RT)

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving more than one drug (combination chemotherapy) together with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with chronic lymphocytic leukemia (CLL) that has not responded to fludarabine (closed to entry as of 10/2006), CLL with autoimmune hemolytic anemia, or Richter transformation.

OBJECTIVES:

Primary

* Determine the efficacy, in terms of the rate and quality of remission, of chemotherapy comprising cyclophosphamide, doxorubicin hydrochloride, vincristine, prednisone, and rituximab (CHOP-R) in patients with fludarabine-refractory chronic lymphocytic leukemia (CLL) (closed to accrual as of 10/2006), CLL with autoimmune hemolytic anemia, or Richter transformation.
* Determine the incidence of infection in patients on CHOP-R regimen.

Secondary

* Determine the toxicity of this regimen in these patients
* Determine the progression-free and overall survival of patients treated with this regimen.

OUTLINE: This is a prospective, multicenter study. Patients are stratified according to disease (chronic lymphocytic leukemia (CLL) (closed to accrual as of 10/2006) vs CLL with autoimmune hemolytic anemia vs Richter transformation).

Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Patients also receive rituximab IV on day 1 of the second course and each subsequent course. Treatment repeats every 21 days for up to 6 (for patients with CLL) or 8 (for patients with Richter's transformation) courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Confirmed diagnosis of previously treated chronic lymphocytic leukemia (CLL) meeting the following criteria:

  * Binet stage B (Rai stages I and II) or Binet stage C (Rai stages III and IV) disease
  * Rapid disease progression, symptomatic enlarged lymph nodes, or severe B-cell symptoms
* CLL with autoimmune hemolytic anemia allowed
* Richter transformation allowed

PATIENT CHARACTERISTICS:

* Life expectancy \> 3 months
* ECOG performance status 0-3
* No severe organ dysfunction
* No other prior or concurrent neoplasms

PRIOR CONCURRENT THERAPY:

* No more than 4 prior chemotherapy regimens