cyrilzakka/clinical-trials huggingface dataset:
Somatic Symptom and Related Disorders: A Treatment Group and Mixed-Methods Investigation

The purpose of this study is to evaluate the effectiveness of a new cognitive behavioural therapy (CBT) group for individuals with a somatic symptom disorder (i.e., Somatic Symptom and Related Disorders from the DSM-5). Patients with somatic symptom and related disorders are underserved by the medical system. Further, there is currently a paucity of research aimed at evaluating treatments for patients with somatic symptom disorders. The limited existing research literature supports CBT as an efficacious treatment in this population, but a standardized means of modifying CBT for somatic symptom disorders has not been developed, and it is unclear if group CBT is effective. In this study, the investigators will evaluate the effectives of a new six session CBT group designed specifically to address commonly-reported difficulties among individuals with somatic symptom disorders, such as somatic symptoms, psychological distress, and related cognitive interference. This study will allow us to validate a new intervention for somatic symptom disorders, and will help to fill the current void of evidence-supported evaluation and treatment protocols to better serve patients with somatic symptom disorders.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older,
2. formally diagnosed with a somatic symptom or related disorder,
3. registered patients of St. Joseph's Healthcare Hamilton, and
4. subjective psychological complaints and somatic complaints causing distress and/or functional impairment.

Exclusion Criteria: individuals with

1. acute and severe depression/suicidal ideation,
2. severe PTSD symptoms,
3. current psychosis,
4. current substance use disorder, or
5. severe cognitive impairment will be excluded from the study and referred to a more appropriate intervention.
Does Consuming Modified Plant Seed Oil Containing Fish Oil Fatty Acids Act in the Same Way as Consuming Fish Oil?

Fish oil and oily fish contain omega 3 long chain polyunsaturated fatty acids known to be beneficial to health. Many people consume little, despite UK government recommendations to eat at least one portion of oily fish per week. Furthermore, despite modest consumption, fish stocks are declining due to over fishing. Therefore, there is a need for an alternative, sustainable and cost efficiently produced dietary source. A seed oil source of these fish oil-type fatty acids has been achieved by adding genes from other plant sources to the oil seed plant Camelina sativa. Camelina sativa, related to mustard and cabbage, has provided seed oil for human consumption for thousands of years. It was the most important oil seed plant in Europe until the 1900's. This research is being done to see if consuming fish oil-type fatty acids in Camelina seed oil allows the body to take up and use the fish oil fatty acids in the same way as it does from fish oil.

This research is being done to see if consuming fish oil-type omega 3 long chain polyunsaturated fatty acids in Camelina seed oil allows the body to take up the fish oil fatty acids in the same way as it does from fish oil.

In the first study (A) the Camelina oil will be used in a meal. The volunteers (healthy men and women) will be asked to consume the meal and provide blood samples in the following 6 hours to look at immediate uptake of the fish oil fatty acids. This will be repeated (for comparison) with fish oil.

The second study (B) will look at consumption over a longer period. Volunteers will be asked to consume the Camelina oil daily for 8 weeks and provide blood samples at the visits at the start and end of that period. This will be repeated (for comparison) with fish oil.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female
2. 18 to 30 years or 50 to 65 years
3. Body mass index 18.5-30.0 kg/m2
4. Health screening results that are within normal clinical ranges
5. Not consuming fish oil or other oil supplements
6. Not eating more than one oily fish meal per week
7. Willing to adhere to the study protocol
8. Being able to provide written informed consent

Exclusion Criteria:

1. Aged \< 18 years; 31-49 years or \> 65 years
2. Body mass index \< 18.5 or \> 30 kg/m2
3. Current smoker
4. Fasting blood cholesterol or glucose concentrations outside the normal concentration range
5. Diagnosed chronic illness (for example diagnosed cardiovascular disease, diabetes, cancer)
6. Use of prescribed medicine to control inflammation
7. Use of prescribed medication to control blood lipids (e.g. statins, fibrates (fenofibrate), Omacor)
8. Use of prescribed medication to control blood pressure (ACE inhibitors, angiotensin 2 receptor blockers, calcium channel blockers, α-inhibitors, thiazide diuretics)
9. Use of fish oil or other oil supplements
10. Chronic gastrointestinal problems (e.g. IBD, coeliac disease, cancer)
11. Pregnant or planning to become pregnant within the study period
12. Participation in another clinical trial
The Current Study Aimed to Evaluate the Therapeutic Features and Complications of Liver Hydatid Cyst in Patients Who Underwent Surgery for CE in Fars Province, Southern Iran.

The current study aimed to evaluate the therapeutic features and complications of liver hydatid cyst in patients who underwent surgery for CE in Fars province, southern Iran.

A total of 293 patients who underwent surgery for liver hydatid cyst from 2004 to 2018 in Fars Province, southern Iran, were retrospectively evaluated. The clinical records of patients were reviewed and the demographic and clinical characteristics of each patient were assessed.

Fars province with the capital of Shiraz in one of the thirty-one provinces of Iran located in the southwest part of the country with a population of more than 4.6 million people of which 67.6% living in urban areas, 32.2% in rural areas and 0.3% live as nomad tribes. The average temperature of Fars province is 17.8 °C, ranging between 4.7 °C and 29.2 °C and the annual rainfall is 261mm. Animal farming and agriculture are of great importance as they are considered as two main economic bases of this province. This type of livelihood has facilitated the presence of some of the zoonotic diseases such as CE and toxocariasis and leishmaniasis.

Data Collection Hospital records of a total of 293 patients who underwent surgery for liver hydatid cyst from 2004 to 2018 in two major university-affiliated hospitals in Fars Province, southern Iran, were retrospectively evaluated. In all cases, the preliminary diagnosis of hydatid cyst has been confirmed by postoperative pathological findings. So, the inclusion criterion of operation with the diagnosis of CE was considered while reviewing the records.

Information such as age, sex, presenting signs and symptoms of hydatid cyst, number and the specific location of cystic structures, history of relapse, reoperation, characteristics of the cyst (calcification, puss discharge, multicystic, multiloculated, daughter cyst, rupture, inflammation, superimposed infection, and septation), early postoperative complications, diagnostic procedures such as ultrasound scanning, computed tomography, X-rays, pathology reports, lab data, operation information and, drug therapy were extracted from the hospital records of each patient. The surgical procedure used for the patients, radical or conservative, was noted.

Eligibility Criteria:
Inclusion Criteria:

Having a surgery due to Hydatid cyst

Exclusion Criteria:

Surgeries other than hydatid cyst.

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Targeted Fluorescence Imaging in AMD

Rationale:

To track performance of intravitreal distribution of anti-VEGF-A (Bevazicumab-800CW) and provide information about neovascularization and inflammation in Age-Related Macular Degeneration (AMD), thereby predicting progression and optimizing treatment

Objective:

To determine the safety and feasibility of fluorescence imaging of the eye with the fluorescent tracer bevacizumab-800CW for identification AMD with scanning laser angiography

Study design:

A non-randomized, non-blinded, prospective, single-center feasibility study.

Study population:

Patients group: patients with naïve wet AMD and wet AMD aged \>60 years old with current treatment of anti-VEGF intravitreal.

Control group: patients with naïve wet AMD and wet AMD aged \>60 years old with current treatment of anti-VEGF intravitreal

Intervention (if applicable):

Intravenous injection of bevacizumab-800CW in the patient group.

Main study parameters/endpoints:

Safety and feasibility of the intravenous tracer bevacizumab-800CW in patients with naïve wet AMD and wet AMD by observing the uptake in retinal, choroid and neovascular tissue.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No risk described in other (running) studies on intravenous injection with bevacizumab-800 CW. Patients need to come back 48-96 hours after injection and the eye measurements take about half an hour longer.

There is no benefit with participation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with either naïve wet AMD or wet AMD receiving standard care of anti-VEGF therapy
* Aged \>60 years old

Optional: Patients already included in fluorescence study which involves Bevacizumab-800CW

Exclusion Criteria:

* Eye pathology interfering with retinal imaging;
* Patients with psychological diseases or medical issues who are not able to sign informed consent form;
* Concurrent uncontrolled medical conditions;
* Received a different investigational drug within 30 days prior to the dose of bevacizumab-800CW;
* History of infusion reactions to bevacizumab or other monoclonal antibody.
Effects of DHEA/Exercise on Bone, Muscle and Balance

The purpose of this study is to examine whether muscle strength and balance will improve in women with frailty selected for dehydroepiandrosterone sulfate (DHEAS) levels below 550 ng/dl treated with DHEAS supplementation and Hatha yoga. Investigators believe the effects of both treatments will improve outcomes more than either treatment alone and may be additive; in addition, lean body mass, skeletal muscle mass, markers of bone turnover and physical performance will improve following treatment with DHEA and/or yoga.

Dehydroepiandrosterone (DHEAS) and yoga may mitigate or reverse the effects of aging and frailty on bone, muscle and balance loss. The mechanism of the effects may be direct - working through androgen or estrogen receptors in bone, muscle or brain. Or the effects may be indirect, countering effects of the stress response.

The specific aims of this study are:

1. To determine the effects of dehydroepiandrosterone sulfate (DHEAS) supplementation and/or Hatha yoga on muscle strength, balance, body composition and physical performance measures over 6 months in women with osteopenia and some degree of frailty
2. To determine the effect of dehydroepiandrosterone sulfate (DHEAS) supplementation and/or Hatha yoga on function (physical and cognitive), bone metabolism, and cardiovascular risk factors.

Eligibility Criteria:
Inclusion Criteria:

* Women over age 65 years
* Bone mineral density t-score less than -1
* At least one of the five components of the frailty phenotype (low hand grip strength, low walking speed, low physical activity, weight loss or sense of exhaustion)
* DHEAS levels less than 550 ng/dl
* Able to come or be brought to the University of Connecticut Health Center (UCHC) for outpatient visits
* Mammogram within the preceding 12 months

Exclusion Criteria:

* Disease or medication known to affect bone or muscle metabolism (i.e., Paget's disease, osteomalacia or 25OHD level less than 10 ng/dl, hyperparathyroidism: current use of corticosteroids, calcitonin, heparin, phenytoin, phenobarbital, methotrexate, bisphosphonates, calcitonin, selective estrogen receptor modulator or PTH)
* Use of androgen or estrogen in the preceding year
* Use of psychiatric medications including antipsychotic medications and SSRI
* Metastatic or advanced cancer (other than skin cancer)
* History of breast cancer
* Active cardiac ischemia by history of angina or myocardial infarction in the preceding 6 months
Interleukin 33 in Juvenile Idiopathic Arthritis Patients

The aim of this study is to measure serum and synovial fluid levels of IL 33 and its relative mRNA expression in peripheral blood mononuclear cells in juvenile idiopathic arthritis (JIA) patients and to correlate it with the clinical and laboratory characteristics, disease activity and musculoskeletal ultrasound findings.

SUBJECTS AND METHODS

Subjects:This study will be a case-control study including sixty children with juvenile idiopathic arthritis attending pediatric rheumatology clinic of Benha University Hospital and Benha children hospital and thirty apparently healthy children as controls. They will be classified into:

* Group (I) study group:60 cases of children with juvenile idiopathic arthritis.
* Group (II) Control group:60 of apparently healthy children matched for age and sex

A)Full history taking

B) Full clinical examination

C) Clinical assessment of disease activity

D) Laboratory Investigations:

All subjects will be investigated by

1. complete blood count.
2. Erythrocyte sedmentation rate.
3. C-reactive protein .
4. Liver enzymes: ALT and AST.
5. Rheumatoid factor.
6. Antinuclear antibody (ANA).
7. serum ferritin
8. serum and synovial fluid Interleukin 33 by ELISA and its relative expression in peripheral blood mononuclear cells by PCR

E) Musculoskeletal Ultrasound examination

Eligibility Criteria:
Inclusion Criteria:

* Children less than 16 years old diagnosed according to ILAR classification criteria of juvenile idiopathic arthritis

Exclusion Criteria:

* 1-Exclusion other causes of arthritis in children as:

  1. Other autoimmune diseases Vasculitis- SLE- Rheumatic fever- Dermatomyositis- Polymyositis- Enteropathic arthritis- Behcet disease- Sjogren-Scleroderma- Mixed connective diseases
  2. Infectious disease or septic arthritis.
  3. Metabolic diseases.
  4. Endocrine diseases.
  5. Neuropathic diseases.
  6. Heritable bone disease.
  7. Neoplastic diseases including leukemia.
  8. Sarcoidosis.
  9. Familial Mediterranean fever. 2-Exclusion of children with diseases that affect serum level of IL 33 as:

  <!-- -->

  1. Inflammatory diseases of airway e.g asthma
  2. Inflammatory bowel disease
  3. Systemic lupus erythmatosus
  4. Inflammatory skin disease e.g :atopic dermatitis
  5. Cancer
Comparison of Different Prophylaxis Regimens for Moderate to Severe Hemophilia A Pediatric Patients

Title: Comparison of different prophylaxis regimens for hemophilia A pediatric patients Principal Investigator: Assistant Professor Darintr Sosothikul, MD Research Question: Does different factor VIII dosage effect outcome of hemophilia treatment in term of breakthrough bleeding, number of hospital stay and day-off from school? Type Research: Clinical research

Study design: Single center clinical trials

Concise methodology:

1. Study Population: Children with hemophilia A who received treatment at KCMH from May 2015 to March 2016 will be enrolled in this study. The consent will be obtained before the study.
2. Observation and measurement:

   1. History, interesting clinical data and laboratory data will be recorded in Clinical record Form (CRF)
   2. Measurement:

   i. Complete blood count (CBC), Factor VIII level, Factor VIII inhibitor level ii. Number of breakthrough bleedings, number of hospital stay and day-off from school iii. Joint score from Hemophilia Joint Health Score 2.1 iv. EQ-5D-5L quality of life assessment score
3. Data analysis: The p-value of less than 0.05 will be considered statistically significant. Mann-Whitney test will be used to test correlation of these variables (CBC, Factor VIII level, Factor VIII inhibitor level, Number of breakthrough bleedings, number of hospital stay, day-off from school, Hemophilia Joint Health Score 2.1, EQ-5D-5L quality of life assessment score) Sample size: 16 patients

Potential impacts:

The outcomes of different factor VIII concentrate dose between 15-20 U/kg/dose 2 times/week and 35-40 U/kg/dose 1 time/week will be revealed. These outcomes include number of breakthrough bleeding, number of hospital stay, day-off from school, joint health and quality of life. The result of this study will guide further study on optimal dose and duration of factor VIII treatment of hemophilia A patients in the future.


Eligibility Criteria:
Inclusion Criteria:

* Hemophilia patients with moderate (factor level 1-3%) or severe (factor level \<1%) severity

Exclusion Criteria:

* Platelet count less than 100,000 /mm3 or other bleeding tendency
* Hemophilia patients who have FVIII inhibitor \>0.6 BU (modified Nijmogen method)
* Hemophilia patients who have no bleeding symptoms
Dose-response Effects of Soybean Oil in Salad Dressing on Carotenoid/Fat-soluble Vitamin Bioavailability in Salad Vegetables

The objectives will be to evaluate the dose-response between the amount of soybean oil in salad dressing and the absorption of: 1) carotenoids, phylloquinone, and tocopherols in salad vegetables; 2) retinyl palmitate formed from the provitamin A carotenoids, alpha- and beta-carotene.


Eligibility Criteria:
Inclusion Criteria:

* General good health as determined by interview, blood biochemistry profile, complete blood count, and plasma lipid and lipoprotein profile

Exclusion Criteria:

* Cigarette smoking, frequent alcohol consumption
* Use of vitamin/mineral supplements
* Lactose intolerance
* Known food allergies
* Body mass index (BMI) 30 or higher
* Eating disorder or restrained eating
* Vegetarianism
* Hyperlipidemia
* Current or planned pregnancy
* Use of hormonal contraceptives (affects chylomicron clearance); use of plant sterols or medications known to affect lipid metabolism
Efficacy of Pegamotecan (PEG-Camptothecin) in Localized or Metastatic Cancer of the Stomach or Gastroesophageal Junction

The purpose of this study is to evaluate the safety and efficacy of pegamotecan (PEG-camptothecin) in patients with pathologically-diagnosed locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction who have relapsed or progressed following one prior chemotherapy treatment regimen.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed diagnosis of adenocarcinoma of the stomach or gastroesophageal junction.
* Disease measurable in at least one dimension.
* Target tumors outside of prior radiation field(s).
* An Eastern Cooperative Oncology Group (ECOG) performance scale score of 0 or 1
* Adequate hematologic profile, as determined by hemoglobin, platelet, and neutrophil count.
* Adequate renal function, as determined by serum creatinine and serum albumin measurements.
* Adequate liver function, as determined by total bilirubin and transaminases levels. Transaminases may be \<= 5.0x ULN if due to metastatic disease in the liver.
* Fully recovered from prior surgery.
* No history of hemorrhagic cystitis.
* No microscopic hematuria (\>10 RBC/hpf) unless documented to be due to an infection or non-bladder origin.
* Capable of understanding the protocol requirements and risks and providing written informed consent.

Exclusion Criteria:

* Concurrent serious medical illness unrelated to tumor within the past 6 months.
* Known chronic infectious disease, such as AIDS or hepatitis (screening for hepatitis and HIV will not be performed).
* Positive screening pregnancy test or is breast-feeding.
* Female or male subject of reproductive capacity who is unwilling to use methods appropriate to prevent pregnancy during the course of this study.
* Receiving concurrent chemotherapy, investigational agents, radiotherapy, surgery, or has received wide field radiation within the previous 4 weeks.
* History of another malignancy (except basal and squamous cell carcinomas of the skin and carcinoma in situ of the cervix) within the last 5 years.
* Known or clinically suspected brain metastases.
* Received more than one prior regimen of chemotherapy for locally advanced or metastatic adenocarcinoma of the stomach or GE junction.
* Received prior neoadjuvant and/or adjuvant cytotoxic chemotherapy
* Received any investigational drug within the last 30 days.
* Not fully recovered from any prior, and from any reversible side effects related to the administration of cytotoxic chemotherapy, investigational agents, or radiation therapy.
* Prior treatment with a camptothecin analog.
A 6-month Follow-up Study of Patients With Severe Fever With Thrombocytopenia Syndrome

This is a multi-center, retrospective clinical study to analyze the clinical features, laboratory indicators, imaging changes, treatment options and long-term prognosis in patients with sever fever with thrombocytopenia syndrome. All hospitalized patients with sever fever with thrombocytopenia diagnosed between 2016 and 2022 were included from the electronic medical record system of 8 centers, and demographics, hospitalization information, clinical information, laboratory or imaging examinations, treatment options, and outcomes were collected.


Eligibility Criteria:
Inclusion Criteria:

* Age and gender are not limited;
* Hospitalized patients diagnosed with severe fever with thrombocytopenia syndrome have at least one of the following laboratory test results: serum severe fever with thrombocytopenia syndrome bunyavirus (SFTSV)-specific IgM antibody positive or IgG antibody level increased more than 4 times; or positive for SFTSV RNA; or positive for SFTSV nucleic acid detected by real-time fluorescent quantitative RT-PCR; or SFTSV isolated from case specimens.

Exclusion Criteria:

* Patients who were found to be positive for other tick-borne pathogens by PCR analysis of blood samples in the acute phase;
* It is difficult to conduct outpatient follow-up due to mental disorders, dementia, combined diseases such as osteoarthropathy, stroke, pulmonary embolism, etc. that lead to inability to move freely;
* No outpatient follow-up visit after discharge, and repeated confirmation by phone call still unable to get in touch;
* Due to living in other places, nursing homes, welfare homes, unable to participate in outpatient follow-up after making an appointment by phone;
* Currently participating in clinical trials of other drugs or medical devices;
* The researchers think it is not suitable for inclusion.