cyrilzakka/clinical-trials huggingface dataset:
Managing Cancer and Living Meaningfully (CALM): A Study to Evaluate the Effectiveness of a Psychological Intervention for Cancer Patients

The purpose of this study is to test the effectiveness of a brief manualized individual psychotherapy, called Managing Cancer and Living Meaningfully (CALM), to reduce distress and promote psychological well-being in patients with various types of cancer, including metastatic disease.

We have developed and pilot-tested a brief manualized individual psychotherapy, called Managing Cancer and Living Meaningfully (CALM), to reduce distress in patients with various types of cancer, including metastatic disease. We propose to conduct a two-arm randomized controlled trial (RCT) to test the effectiveness of CALM against usual care (UC) for the reduction of distress in patients with various types of cancer, including metastatic disease. Usual care at our center includes routine screening for depression and other distress in oncology outpatient clinics, communication of screening information to the medical treatment team, and referral as needed for non-standardized, and primarily instrumental, psychosocial care and psychiatric assessment and treatment.

The design will be an unblinded RCT consisting of two conditions (CALM and UC), with a baseline assessment and follow-ups at three and six months. The trial will take place in Princess Margaret Cancer Centre, University Health Network, a comprehensive cancer center in Toronto, Canada. Participants will be outpatients with various types of cancer, including metastatic disease.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Fluency in English
* Confirmed diagnosis of stage III or IV lung cancer; any stage of pancreatic cancer, unresectable cholangiocarcinoma, unresectable liver cancer, unresectable ampullary/peri-ampullary cancer, or other stage IV (metastatic) gastrointestinal cancer; stage III or IV ovarian and fallopian tube cancers, or other stage IV gynecological cancers; and stage IV breast, genitourinary, sarcoma, melanoma or endocrine cancers (all with expected survival of 12-18 months)

Exclusion Criteria:

* Major communication difficulties (including language barriers)
* Inability to commit to the required 3-6 psychotherapy sessions
* Cognitive impairment indicated in the medical record, or by the attending oncologist, or as indicated by a score \< 20 on the Short Orientation-Memory-Concentration test, unless deemed suitable at the recruiter's discretion
* Actively seeing a psychiatrist or psychologist in the Department of Supportive Care (formerly the Department of Psychosocial Oncology and Palliative Care) at Princess Margaret Cancer Centre at the time of study approach
Bladder Thermal Distention for Patients With Refractory Overactive Bladder

In this study, the investigators will evaluate the efficacy of Bladder Thermal Distention (BTD) in patients with overactive bladder syndrome who failed previous treatment of anticholinergic drugs.

The investigators' hypothesis is that it will improve the storage symptoms.

Inclusion criteria:

1. Patients with overactive bladder syndrome
2. Detrusor Overactivity proven in urodynamic test

Exclusion criteria:

1. Mixed urinary incontinence
2. Active urinary tract infection
3. Urethral Stricture

Outcome measures:

1. Bladder Diaries
2. Urgency questionnaire

Eligibility Criteria:
Inclusion Criteria:

* Patients with overactive bladder syndrome
* Detrusor Overactivity proven in urodynamic test

Exclusion criteria:

* Mixed urinary incontinence
* Active urinary tract infection
* Urethral Stricture
Prolactin Levels in Type 2 Diabetic Patients With Stage III Periodontitis

evaluate the role of prolactin hormone in the pathogenesis of periodontitis by assessing its local gingival levels and assess clinical parameters in patients who have type two diabetes

Periodontal Examination At baseline, all participants received a full-mouth clinical examination, and the following periodontal parameters will be recorded: Plaque Index (PI) (19), Gingival Index (GI) (20), Pocket Depth (PD), and Clinical Attachment Loss (CAL).

Initial periodontal examination, full mouth scaling and root planning (SRP), clinical measurements before and after treatment, gingival crevicular fluid sampling as well as reinforcement of oral hygiene at baseline and during follow-up evaluations will be performed by the same periodontist (E.A.). Reinforcement of oral hygiene will be done every month for 3 months.

Gingival fluid sampling:

Gingival crevicular fluid (GCF) collection will be done the second day after clinical examination to prevent the contamination of sample with blood associated with the probing of inflamed sites. Samples will be collected from the buccal aspects of two interproximal sites in teeth that had the highest signs of inflammation and attachment loss for periodontitis groups, this will be done before, and 3 months after SRP. For the control group, samples will be collected from the upper first molar.

The samples will be assayed for PRL by using an enzyme linked immunosorbent assay (ELISA) kits.

Patient's examinations:

Glycosylated Hemoglobin (Hemoglobin A1c) test and Body Mass Index will be measured to all participants.

Eligibility Criteria:
Inclusion Criteria:

* Age range from 18 to 60 years
* Stage III periodontitis
* Type 2 diabetes
* Only patients signing informed written consents

Exclusion Criteria:

* Pregnancy or lactation
* Any known systemic disease
* Any type of previous periodontal treatment (surgical or non-surgical) in the preceding 6 months
* Smoking (former or current)
Patient Provider Partnership: Improving Diabetes Care in the Community

With the advent of managed care, increasing responsibility for the care of patients with diabetes is being placed on primary care physicians. Evidence exists that physicians are not meeting established practice guidelines, and outcomes in patients with diabetes are less than optimal. It is thus the objective of this study to institute a community-based diabetes education intervention for both physicians and patients to enhance adherence to guidelines and improve patient outcomes.

We will conduct a chart review (submitted under a separate IRB: #000733) in primary care practices to determine health status and guideline adherence. Following the chart review, physician practices will be assigned to one of three groups: physician + patient education, physician education alone, and usual care. Following the intervention, a repeat chart review will be conducted. Pre and posttest comparisons will be conducted to examine changes primarily in glycemic control, quality of life, patient knowledge, and physician adherence to practice guidelines. Secondarily, we will examine changes in therapeutic intervention, body mass index, and barriers to diabetes care. We will also examine individual barriers to diabetes care and their influence on outcomes in this population. The last phase of the study will encompass a second follow-up visit in which we will examine behavioral factors related to clinical change and sustainability of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* over age 18, diagnosed diabetes, physician is participating in study

Exclusion Criteria:

* pregnancy, imprisonment
Undisplaced Femoral Neck Fractures

Purpose The purpose of this study is to compare the clinical outcome and the rate of reoperations in a cohort of patients with undisplaced femoral neck fractures treated with internal fixation and patients with displaced femoral neck fractures treated with hip arthroplasty.

Methods In a consecutive series of patients we compared the results of internal fixation for undisplaced femoral neck fractures with those of hip arthroplasty for displaced fractures (control group) of elderly patients. Risk of reoperation and patient reported hip function assessed with Harris hip score and WOMAC were used as outcome measurements.


Eligibility Criteria:
Inclusion Criteria:

Above 65 years old Displaced femoral neck fracture treated with hip arthroplasty Undisplaced femoral neck fracture treated with internal fixation

Exclusion Criteria:

* Pathologic fracture
The Effect of SHR20004（Noiiglutide ） on Body Weight in Obese Subjects Without Diabetes

The study is being conducted to assess the efficacy and safety of SHR20004 on body weight in obese subjects without diabetes.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent obtained prior to any trial-related activities
2. Body mass index (BMI) between 28 and 40 kg/m2(both inclusive)
3. Diet and exercise management for at least 3 months before screening and less than 5% change in body weight during the previous 3 months（self-reported）.

Exclusion Criteria:

1. History of endocrine disease or treatment that may significantly affect body weight prior to screening visit
2. History of diabetes
3. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2)
4. History of pancreatitis
5. Previous surgical treatment of obesity
6. Screening calcitonin of 20 ng/L or above
Study of Treatment Effects of Combination Therapy of Lucentis Plus Reduced Fluence PDT With Visudyne in Patients With Exudative AMD

The purpose of this study is to determine the benefits, if any, of combination therapy with Lucentis plus reduced fluence photodynamic therapy with Visudyne.

The study will have two treatment groups. Each group will receive intravitreal injections (injection of medication in the jelly-like part of the back of the eye). One group (Group1) of approximately 15 patients will receive 0.5 mg of Lucentis™ followed by reduced fluence Photodynamic Therapy (PDT) with Visudyne ® 1-2 weeks later. The other group (Group 2) of approximately 15 patients will receive 0.5 mg of Lucentis™ followed by Photodynamic Therapy with Visudyne on the same day. patients will be assigned at random to receive one of the two treatments arms in the study. The dose received at the first injection will be the same dose received throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Ability to give informed consent
* Treatment- naïve patients with active, subfoveal, exudative AMD
* Patients with visual acuity of 20/40-20/320 in the study eye
* Subfoveal choroidal neovascularization (CNV) must be at least 50% of the total lesion size Total area of lesion components other that CNV must be less than 50% of the total lesion size
* The lesion must be \< 5400microns in greatest linear dimension (GLD)
* Lesion size \< 10 DA
* Occult with no classic CNV lesions must have presumed recent disease progression:

  1. Blood associated with the lesion at baseline
  2. Loss of visual acuity in the previous 3 months: a: \> 5 letter loss (ETDRS equivalent) or b: 2 or more lines using a snellen or equivalent chart
  3. \> 10% increase in GLD as assessed by fluorescein angiography in the previous 3 months
* Previous treatment for CNV with anti-VEGF agents, intraocular steroids and/or Photodynamic therapy with Visudyne® in the study eye
* Geographic atrophy or fibrosis in the study eye
* Intraocular surgery within 6 weeks of enrollment
* Subretinal hemorrhage \> 50% of the total lesion
* Patients with intraocular pressure greater than 30 mm/Hg on 2 pressure-lowering medications
* Patients with severe disciform scarring.
* Inability to make study visits
* Advanced glaucoma
* Allergies to porfins or a known hypersensitivity to any component of Visudyne®
* Patients with porphyria
* Pregnancy or lactation
Development of Urologic Registry for Personalized Medicine in Patients With Urological Malignancy by Analyzing Circulating Tumor DNA

Urological malignancies such as prostate cancer and renal cell cancer in Korean population have been increased due to the aged population and the westernized lifestyles. With the advancement of sequencing technologies, use of genetic mutation profiles in cancer detection and progression has been increased. However, use of circulating tumor DNA in urological malignances have been limited and few studies have been reported. Therefore, we tried to evaluate the usefulness of circulating tumor DNA in detection and monitoring of urological malignancies in Korean population. This study aims to use circulating tumor DNA in plasma and urine for the diagnosis, disease progression monitoring and therapeutic response evaluation. This study plan includes building big databases for circulating tumor DNA of urological malignancies in Korean population and to develop optimized circulating tumor DNA platform.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients diagnosed as urological malignances (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer)
* 2. Patients who have undergone surgeries due to urological malignancies in Severance Hospital, Sinchon from 2019.12 and 2029.11
* 3. Those who agree to give permission to use their human source information - 4. Those who agree with this study

Exclusion Criteria:

* 1. Those who do not agree with this study
* 2. Vulnerable participants who are likely to be vulnerable to coercion or undue influence or lack decision-making
Cognitive Training on Sleeping Disorders in Stroke

Cognitive impairment and sleeping disturbance following stroke diagnosis are common symptoms that significantly affect the quality of life.

40 patients from both sexes will participate in this study. All the patients have to be diagnosed as stroke patients. The patients will be divided into two groups; group A (20 patients): which will receive cognitive training combined with instructive conventional treatment for a sleeping disorder, and group B (20 patients): which will receive instructive conventional treatment for sleeping disorder all the patients will be assessed pre and post-treatment using 1- Epworth sleeping scale, 2-Pittsburgh sleep quality index ( PSQI) 3- MINI mental cognitive scale

Eligibility Criteria:
Inclusion Criteria:

* stroke onset at least 5 months prior to study enrolment
* with sleeping disturbance
* age will range from 40:55
* upper extremity spasticity ranging from
* according to Modified Ashowrth Scale.

Exclusion Criteria:

* difficulty to communicate
* other neurological conditions that cause sleeping disorders
* severe depression or other psychiatric symptoms.
Effect of Treatment With Insulin VIAjectTM Compared to Regular Human Insulin and Insulin Lispro on Mealtime Blood Vessel Stress in Patients With Type 2 Diabetes Mellitus.

The purpose of this study is to compare the effects of insulin VIAject with Regular Human Insulin and Insulin Lispro on measures of mealtime blood vessel stress and blood flow.


Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes mellitus according to the ADA criteria
2. HbA1c between 6.5 % and 9.9 %
3. Treatment with sulfonylurea and/or metformin in a stable dosage within the last 3 months
4. Age between 40 and 75 years
5. BMI \< 40

Exclusion Criteria:

1. Type 1 diabetes mellitus
2. Pre-treatment with insulin within the last 6 months prior to screening
3. Pre-treatment with PPARy-agonists or glucosidase inhibitors within the last 4 weeks prior to screening
4. Untreated hypertension stage II-III according to WHO criteria
5. Planned or anticipated change in antidiabetic and/or concomitant medication during study participation
6. Total cholesterol \> 300 mg/dl (anamnestically)
7. Major micro- or macrovascular complications as judged by the investigator
8. Tobacco use within the last 6 months prior to screening
9. Drugs with major impact on endothelial function like nitrates etc.
10. History of drug or alcohol abuse which in the opinion of the investigator will impair subject safety or protocol compliance
11. History of hypersensitivity to the study drugs or to drugs with similar chemical structures
12. History of severe or multiple allergies
13. Treatment with any other investigational drug within 3 months prior to screening
14. Progressive fatal disease
15. History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT \> 3 times the normal reference range), renal (creatinine \> 1.1 mg/dL in women and \> 1.5 mg/dL in men), neurological, psychiatric and/or haematological disease as judged by the investigator
16. Pregnancy or breast feeding
17. Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner
18. Lack of compliance or other similar reason that at the discretion of the investigator precludes satisfactory participation in the study
19. Hypopotassemia (K\<3.5 mmol /l)
Electro-acupuncture (EA) in Children Undergoing Procedures for Congenital Heart Defects.

This is a single site, randomized, blinded, sham controlled, parallel group study to identify whether electro-acupuncture (EA) is a beneficial anesthesia adjunct in children undergoing procedures on their congenital heart defects (CHD).

This investigation is a single site, randomized, blinded, sham controlled, parallel group study to identify whether EA is a beneficial anesthesia adjunct in children undergoing procedures on their congenital heart defects.

Study subjects age's birth to eighteen years, undergoing cardiac surgery for their congenital heart lesions will be considered for entrance into the study. The randomized subjects will receive either EA or sham during their surgery for CHD. Subjects are expected to remain in the hospital 48 hours post procedure. Standard of care blood samples will be obtained pre-operative and post-operative. The only study specific blood sample will be Troponin I levels which will be obtained before surgery begins after the IV lines have been placed, and 6 hours after bypass. Urine samples will be obtained before surgery after placement of the foley catheter and every 6 hours post bypass aortic cross clamp removal for 48 hours while the foley catheter is still in place.

Eligibility Criteria:
Inclusion Criteria:

* Patients 0-18 years of age undergoing procedures on their congenital heart defects where an aortic cross clamp will be placed.

Additionally, patients with coarctation of the aorta for repair will be considered as a separate group and eligible for enrollment.

* Willing to provide written Assent/Consent in English.

Exclusion Criteria:

* Patients with skin lesions over more than 50% of EA sites.
* Patients in renal failure.
* Patients on chronic opioid therapy.
* Unwilling to provide written Assent/Consent in English.
Safety and Preliminary Efficacy of the Treatment of Kidney Allografts With Curcumin-containing Preservation Solution

The safety and preliminary efficacy of the addition of an aqueous curcumin-cyclodextrin complex (CDC) solution to graft perfusion solution is studied. CDC has proved safe and highly effective in preventing primary graft non-function, delayed graft function and chronic dysfunction in pre-clinical kidney transplantation animal models. The hypothesis is that addition of CDC to the graft perfusion solution will decrease the incidence of delayed graft function in human kidney transplantation subjects.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ESRD assigned for kidney transplantation, written informed consent

Exclusion Criteria:

* None
Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease

This randomized, intra-patient comparative study is designed to investigate the combination regimen of 5-fluorouracil cream (5FU) and Photodynamic Therapy (PDT), versus PDT alone, for its ability to generate significantly elevated levels of the target photosensitizer, protoporphyrin IX (PpIX), in lesions of actinic keratoses (AKs) and to more effectively treat and prevent recurrence of AKs. The target population comprises patients with solid organ transplants (renal, hepatic), as well as normal (immunocompetent) subjects to control for possible influences of immunosuppression.

This clinical trial will test a new combination of 5-fluorouracil cream (5FU) and methylaminolevulinate photodynamic therapy (MAL-PDT), versus MAL-PDT alone, as treatment for actinic keratoses (AKs) in immunosuppressed organ transplant recipients (OTRs) and an immunocompetent control group. Objectives: 1) Determine whether topical pretreatment with 5-FU selectively increases the amount of photosensitizer (PpIX) produced within AK lesions, relative to non-pretreated lesions. 2) Determine whether the combination treatment improves lesion resolution and reduces the incidence of new AKs. 3) Determine whether biomarkers in tissue and blood are predictive of patient responsiveness to 5FU (PpIX induction, new lesion incidence, and clinical toxicity).

We plan to enroll 20 organ transplant recipients and 20 normal patients, with AKs on face, scalp, ears, forearms or back of the hand through Dermatology and Transplant Clinic at Cleveland Clinic. Women of childbearing age must use contraception and have a negative pregnancy test.

Study participants will apply 5FU daily for 6 days; MAL/PDT is administered on 7th day. PpIX will be measured in lesions using a noninvasive dosimeter. Biopsies will be taken from selected lesions, and AKs will be photographed. Participants will be asked to complete a questionnaire to document adverse events. Patients are evaluated at day 14, and months 3, 6, 9, 12, to document AK clearance and new lesion appearance.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* At least four (4) actinic keratoses, located on face, ears, scalp, forearms and/or dorsal hands. - Patients in the solid organ transplant arm of the study must have had either a kidney or liver transplant, and the transplantation surgery must have occurred at least 2 years prior to enrollment.

Exclusion Criteria:

* Pregnant or nursing
* Currently participating in another clinical trial
* Using any topical treatment for their actinic keratoses
* Currently being treated for other cancers with medical or radiation therapy
* Patients with a known hypersensitivity to 5-aminolevulinic acid, 5-fluorouracil or any component of the study material
* Patients with a history of a photosensitivity disease, including porphyria cutanea tarda