cyrilzakka/clinical-trials huggingface dataset:
Study of Tissue, Blood, and Urine Samples From Patients With Advanced Prostate Cancer

RATIONALE: Studying samples of tissue, blood, and urine from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat the cancer.

PURPOSE: This research study is looking at tissue, blood, and urine samples from patients with advanced prostate cancer.

OBJECTIVES:

* To study molecular pathology and mechanisms of disease progression.
* To develop novel treatment strategies for patients with advanced prostate cancer.
* To evaluate novel markers and treatment and epidemiological approaches.

OUTLINE: This is a multicenter study.

* Program I (Molecular Signaling in Advanced Prostate Cancer): Researchers from Newcastle, York, and Bristol analyze androgen receptor (AR) (i.e., AR regulated genes and AR co-activators and co-repressors) and fibroblast growth factor (FGF) signaling and examine the cross-talk between these two systems and the insulin-like growth factor (IGF) axis.
* Program II (Mechanisms of Skeletal Metastases): Researchers from Newcastle, Sheffield, Bristol, and Manchester analyze mechanisms of skeletal metastases and candidate factors responsible for skeletal metastases (e.g., BMP-6, TGF-β1, IL-6, and IL-6 receptor). The balance between proteases and their inhibitors is also analyzed.
* Program III (Prostate Targeting, Models, and Novel Approaches to Therapy): Researchers from Newcastle, Sheffield, York, and Manchester analyze and develop reagents and methods that will facilitate novel gene-based approaches to therapy, including prostate tissue specific gene expression, model systems of gene function and therapeutic studies, translational gene-based therapies, and effectors for potential gene therapy.
* Program IV (Developmental Therapeutics): Researchers from Newcastle, York, and Manchester analyze novel proteins identified during the study to synthesize novel reagents aimed at disrupting pathways and signaling molecules that have been shown to be of critical importance to prostate cancer (e.g., AR and FGF signaling).
* Program V (Biorepository and Database): Tissue, DNA, blood, serum, and urine samples from Newcastle, Sheffield, and Manchester biorepositories are stored and used for analysis in programs I-IV. Support for tissue and data collection as well as database management is provided to enable these resources to be made available to the wider research community.
* Program VI (Clinical Trials and Health Services Research): Researchers from Newcastle, Sheffield, Manchester, and Bristol participate in phase I trials using dendritic cells and gene-directed enzyme prodrug therapy (GDEPT) approaches to analyze environmental interactions with the genotype and evaluate prevention strategies (e.g., diet) that may underlie variations in the incidence of prostate cancer.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of advanced prostate cancer

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
App-based Symptom Tracking After Corona Vaccination (CoCoV)

The study investigates the side effects of different COVID-19 vaccines.

In this observational study side effects of COVID-19 vaccines will be documented using an open-source mobile application. Participants are invited to answer a questionnaire on a daily basis. Common and unknown events are queried and collected. The primary result of this study will be a descriptive analysis of the collected data.

Eligibility Criteria:
Inclusion Criteria:

* received COVID-19 vaccination
* age ≥ 18 years
* mobile device (iOS or Android)

Exclusion Criteria:

* No knowledge of German or English language
* No written informed consent
Determining Prognostic Immune Markers in Patients With Ovarian Cancer

The IMPRoVE study is a prospective, non-interventional, explorative cohort study to determine prognostic immune markers in patients with epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer (EOC).

Tumor material, ascites (if possible) and blood samples for immune monitoring will be collected from patients with primary and recurrent EOC undergoing surgery, chemotherapy and/or immunotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with (suspicion of) primary or recurrent EOC with an indication for surgery, chemotherapy and/or immunotherapy.
* Age ≥18 years.
* WHO performance status 0-2.
* Accessible for treatment and follow-up.
* Written informed consent.

Exclusion Criteria:

* Other active malignancy in past 5 years prior to entry into the study, except for treated non-melanoma skin cancer.
* Any known severe infection like HIV, hepatitis A, B and C.
* Receiving immune suppressive treatment.
* Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
A Study of Lithium and Enlicitide in Healthy Adult Participants (MK-0616-034)

Researchers have designed a new study medicine called enlicitide decanoate (MK-0616) as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called "enlicitide" from this point forward. Lithium (also called lithium carbonate) is a medicine used in bipolar disorder.

Researchers want to learn about lithium when taken at the same time with enlicitide.

They want to:

* Measure a person's blood to find out if the amount of lithium in the blood is the same when lithium is taken alone or with enlicitide
* Learn about the safety of lithium when taken alone or with enlicitide and if people tolerate it


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is medically healthy with no clinically significant medical history
* Is a continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history or presence of clinically significant medical or psychiatric condition or disease
* Has a history of cancer
Inflammation-Induced CNS Glutamate During Breast Cancer Treatment

The purpose of this study is to try and provide data linking the impact of increased inflammatory cytokines as a result of chemotherapy and their relationship with increased levels of CNS glutamate and related behavioral and cognitive consequences in breast cancer patients. The investigators will use neuropsychiatric assessments, blood sampling and Magnetic Resonance Spectroscopy (MRS) to collect study data.

Approximately 70% of women with breast cancer experience behavioral and/or cognitive symptoms during treatment with chemotherapy and approximately 30% of women continue to experience these symptoms months to years after treatment completion. There is mounting data to suggest that inflammation may be involved and indicate that chemotherapy-treated breast cancer patients exhibit higher inflammatory markers than non-chemotherapy-treated patients, and inflammatory markers including interleukin (IL)-6 and soluble tumor necrosis factor (sTNFR2) have been associated with chemotherapy-induced depression and fatigue.

Eligibility Criteria:
Inclusion Criteria:

* Female breast cancer patients will have undergone surgery (lumpectomy or mastectomy) with or without neoadjuvant or adjuvant chemotherapy
* Age between 21-65 years

Exclusion Criteria:

* Taking trastuzumab
Effects of Green Tea on Level of Serum Uric Acid in Healthy Individuals

Green tea has been extensively investigated for several potential health benefits. Previous studies have suggested that green tea may lower serum uric acid level in human. The purpose of this study is to investigate uric-lowering properties of green tea in healthy individuals.

Elevated serum uric acid is related to the risk of development of gout, the most common inflammatory arthritis in men. Allopurinol, a xanthine oxidase inhibitor, is one of the uric-lowering agents commonly used in patients suffering from recurrent and chronic gout. Nevertheless, its use is limited by adverse effects and serious allergic reaction in some patients.

Green tea is one of the most frequently consumed beverages, particularly in Japan. Green tea contains high level of catechins, in which Epigallocatechin gallate (EGCG) is the most abundant compound among other types of catechins. Antioxidant effect contributes to various potential health benefits of green tea. Several in-vitro studies have found that green tea inhibits xanthine oxidase activity and subsequently decreases reactive oxygen species (ROS) and uric acid production. We therefore would like to investigate the hypouricemic effects of green tea.

The study consists of three periods with a total duration of four weeks. The first week is the control period. The following two weeks is the interventional period and the last week is the follow up period. Thirty healthy participants will be randomly assigned into three experimental groups, receiving 2 gm/day, 4 gm/day and 6 gm/day (in capsule, two times after meal) of green tea extract during interventional period. Blood and urine samples will be taken at the beginning and at the end of each study period.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Healthy individuals
* Normal renal and liver function from blood tests

Exclusion Criteria:

* Presence of co-morbidity or currently ill
* Currently using any medication or nutritional supplement product that may affect serum uric acid level
* Serum creatinine higher than 1.5 mg/dl
* Abnormal serum Aspartate aminotransferase (AST) and/or Alanine transaminase (ALT)
* Greater than 15% change in serum uric acid during control period
Dual-task Obstacle Crossing Training in Ambulatory Subjects With Spinal Cord Injury

Is dual-task obstacle crossing training more efficiently than single-task obstacle crossing training on the improvement of walking ability, balance ability, and lower extremity muscle strength in ambulatory subjects with spinal cord injury

To compare immediate effects of dual-task and single-task obstacle crossing training in ambulatory subjects with spinal cord injury

Eligibility Criteria:
Inclusion Criteria:

* independent ambulatory subjects with
* traumatic causes or non-progressive diseases
* sub-acute and chronic stage of injury (at least 3 month after injury)
* body mass index (BMI) between 18.5-29.9 kg/m2
* walk independently for at least 17 meters with or without assistive devices (Functional Independence Measure Locomotor (FIM-L) scores 5-7)
* able to read Thai

Exclusion Criteria:

* pain in the musculoskeletal system with a pain scale more than 5 out of 10 on a the visual analog scale (VAS)
* deformity in the joints that affect ambulatory ability
* unable to understand the commands and tests used in the study
Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement

This study is to prospectively compare Ultrasound guided (US-G) Ventriculoperitoneal Shunt (VPS) placement to stereotactic navigation in a randomized controlled fashion with the surgical intervention time as primary outcome. All patients entering the University Hospital of Basel for elective or emergent VPS surgery will be randomized in 1:1 fashion to one of the study groups at admission or the day before the operation.

Ventriculoperitoneal shunt (VPS) placement is one of the most frequent procedures in neurosurgical practice. The position of the proximal ventricular catheter is important since it influences possible malfunction of the VPS. For the improvement of accuracy in proximal VPS placement, navigation-based insertion techniques have been developed. VPS placement using stereotactic navigation has shown a high accuracy of catheter placement been developed. VPS placement using stereotactic navigation has shown a high accuracy of catheter placement, while the main limitations are that for referencing, the head of the patient needs to be fixed in a head holder and the preoperative set-up can be time-consuming. US-G VPS placement using a burr hole probe was described as an alternate for image-guided VPS placement technique. For US-G VPS placement head fixation or preoperative registration is not needed. This study is to prospectively compare Ultrasound guided (US-G) Ventriculoperitoneal Shunt (VPS) placement to stereotactic navigation in a randomized controlled fashion with the surgical intervention time as primary outcome.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Patients undergoing elective or emergent VPS placement (frontal or occipital shunt )

Exclusion Criteria:

* Revision surgery due to former VPS placement using the same side and location for VPS placement or when no complete shunt is revised (proximal and distal), resulting in a shorter operation time
* Ventriculoatrial or ventriculopleural Placement
* Women who are pregnant or breast feeding
* Intention to become pregnant during the course of the study
* Previous enrolment into the current study
* Enrolment of the investigator, his/her family members, employees, and other dependent persons
Effectiveness of a Pain Education Program on Chronic Neck Pain Patients

This project aims to study the effectiveness of a pain education program in the improvement of chronic pain and disability/impairment. Assuming the definition established in the United States in 1975 on the fourth working group of the National Conference on Preventive Medicine: "Health education must be a process that informs, motivates and helps people to adopt and maintain practices and healthy lifestyles, environmental advocates changes necessary to facilitate these objectives and professional training and directs research towards the same objectives. " Once the need of educating patients is stablished on subjects with diseases, it is necessary to encourage them to actively participate on the control of them and to achieve significant improvement of adherence

BACKGROUND AND PURPOSE:

Patient education over the knowledge of pain causes and perpetuating psicosocial factos, so as a gradual physical therapy intervention may success in modifying habits, and consequently emotional state and behaviour in order to maintain or recover subject's social participation being this program effective in pain diminution over chronic neck pain.

Main goal: To evaluate the effectiveness of a pain education program for patients with chronic neck pain, to decrease the intensity of pain in front of one physiotherapy program (TENS and exercise)

Experimental group: Will receive five group sessions of 60-120 minutes twice a week with a maximum of 10 participants.

Control group: Five individual sessions twice a week, will be performed of transcutaneous electrical nerve stimulation (TENS) on neck area an exercises.

OUTCOMES

Primary outcome

* Intensity of pain, measured by the visual analog scale: VAS. The mean of the values wil be calculated described in the assessment, the mean of the last week was also compiled.
* The degree of neck disability/impairment measured using the Northwick Park Pain Questionnaire (NPPQ)

Eligibility Criteria:
Inclusion Criteria:

* Subjects over 18 years old
* Subjects diagnosed with chronic neck pain.

Exclusion Criteria:

* Patients with acute and subacute neck pain. Those presenting inflammatory, neurologic, rheumatic or heart disease or pacemakers. Patients with severe osteoporosis, fractures, dislocations, vertebrobasilar insufficiency, infection, metastatic tumor, pre and post-surgical etiology recent (less than one year after the intervention).

Psychopathology patients diagnosed by their doctor. Subjects who do not understand or speak the Spanish language.
Validation Study of Coronary CT Angiography as a Screening Tool in Asymptomatic Diabetes

The purpose of this study is to evaluate the prevalence and clinical predictors of subclinical coronary atherosclerosis and to validate the usefulness of coronary CT angiography as a screening tool in asymptomatic patients with type 2 diabetes mellitus.

Coronary artery disease (CAD) is the leading cause of death in patients with diabetes. Patients with diabetes are known to have silent myocardial ischemia more frequently than those without diabetes. Furthermore, CAD in patients with diabetes frequently manifested in advance stage, and morbidity and mortality are higher than those without diabetes. Early screening and treatment of CAD in asymptomatic patients with diabetes might reduce high morbidity and mortality.

In recent advance in technology, coronary CT angiography makes it more accurately and easier in detecting CAD not only in symptomatic patients but also in asymptomatic population. In asymptomatic population, coronary CT angiography could detect subclinical coronary atherosclerosis with high sensitivity and specificity. However, there is a paucity of information on the role of coronary CT angiography as a screening method in high risk asymptomatic population, i.e. asymptomatic patients with diabetes.

Therefore in our study, we will evaluate the prevalence and clinical predictors of subclinical coronary atherosclerosis and to validate the usefulness of coronary CT angiography as a screening tool in asymptomatic patients with type 2 diabetes mellitus.

In this study, we will recruit asymptomatic patients with diabetes. At the time of enrollment, patients will be randomly assigned to coronary CT angiography group or control group using web-based randomization table. One-half of patients will be assigned to coronary CT angiography imaging and follow-up, whereas the other half will be randomized to medical treatment and follow-up only.

When the patients are eligible for study, investigators will give information about the study and obtain written consent. The presence of chest pain symptom will be screened with Rose questionnaire. Medical history and physical examination will be performed, and baseline laboratory work-up will be performed. Investigators will evaluate the status of diabetic complication (retinopathy/nephropathy/cardiac autonomic neuropathy).

After initial clinical and laboratory evaluation, all patients will be followed for adverse cardiac events for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Age 50 \~ 75 years

Exclusion Criteria:

* angina pectoris or anginal equivalent symptoms
* insulin pump user or history of ketoacidosis
* history of myocardial infarction, heart failure, or coronary revascularization
* electrocardiographic evidence of Q-wave myocardial infarction, ischemic ST- segment or T-wave changes, or complete left bundle branch block
* uncontrolled arrythmia
* hypersensitivity to contrast dye
* renal failure
* uncontrolled arrythmia
* hypersensitivity to contrast dye
* renal failure
Growth Hormone to Improve the Clinical Outcome of Assisted Fertility in Young Patients With Decreased Ovarian Reserve

This study was a prospective randomized controlled trial. Patients aged \<35 years with decreased clinical reserve function (AFC\<5, Follicle stimulating hormone \> 10miu/ml, Anti-mullerian hormone \< 1.1μg/L) and receiving IVF/ICSI assisted ovulation induction in our hospital were included in this study. After randomization using Excel(Microsoft Corporation, Albuquerque, USA), these patients were divided into two groups. Group A was the experimental group, which was treated with growth hormone for 3 months (2 units per day) before IVF/ICSI. Group B was the control group, which was directly assisted by IVF/ICSI.


Eligibility Criteria:
Inclusion Criteria:

1. Age \< 35 years;
2. AFC≤5
3. Follicle stimulating hormone \> 10miu/ml;
4. Anti-mullerian hormone \< 1.1μg/L

(2 out of 2-4 items can be met)

Exclusion Criteria:

1. Severe male factors: spermatozoa collected by testicular sperm aspiration (TESA) or percutaneous epididymal sperm aspiration (PESA) was used for intracytoplasmic sperm injection (ICSI) cycle of single spermatozoa;
2. Patients with severe adenomyosis, endometriosis, intrauterine adhesions and other diseases that significantly affect embryo implantation;
3. Diabetes mellitus, insulin resistance;
4. chromosomal karyotype abnormality in either spouse;
5. Any pregnancy or contraindications of assisted reproductive technology;
This Study Aim is to Compare the Effect of Oral Methyl Prednisolone on Different Radiological Patterns of Hypersensitivity Pneumonitis as it Was Found That Not All Patients Get Satisfying Therapeutic Effect After Taking Corticosteroids.

The Aim of This Work is to Compare the Effect of Oral Methyl Prednisolone on Different Radiological Patterns of Hypersensitivity Pneumonitis and to Evaluate the Patient's Clinical and Functional Status After Taking the Required Dose of Methyl Prednisolone. Not All Hypersensitivity Pneumonitis Patients get the Same Therapeutic Effect after taking Corticosteroid so by Comparing the Effect of Methyl Prednisolone on Patients With Different Radiological Pattern we Will be Able to Select the Patient Who Really Need to Take Corticosteroid and Who Don't so we Will Protect the Patient Who Doesn't Need to Take Oral Corticosteroids From Its Numerous Side Effects All Patients Will Undergo the Following Assessment Before and After Taking 0.5 mg/kg/Day of Methyl Prednisolone for 8 Weeks : High Resolution CT (HRCT) of Chest , Chest X-ray , Spirometry, 6 Minute Walk Test to Evaluate the Patient's Functional Status and Oximetry to Measure Percentage of Oxygen in Blood

hypersensitivity Pneumonitis patients will be divided in two groups : non- fibrotic hypersensitivity Pneumonitis patients ( nfHP) and fibrotic hypersensitivity Pneumonitis patients ( fHP), based on HRCT findings.

All patients will undergo the following assessment at the beginning of the study: High resolution CT (HRCT) of chest , Spirometry to assess forced expiratory volume in 1 second (FEV1), Forced vital capacity (FVC) and FEV1 to FVC ratio , 6minute walk test , Oximetry to measure percentage of oxygen in blood. Then all patients took methyl prednisolone 0.5mg/kg /day orally for 8 weeks .

During the treatment period Pulmonary spirometry will be done every 2 weeks and 6 minute walk test will be done every 4 weeks as follow up At the end of the treatment period all these assessments will be repeated to compared the patients functional and clinical statues before and after taking methylprednisolone.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of hypersensitivity pneumonitis.
2. Adults (older than 18 years).
3. Having history of exposure to allergen
4. Steroid naïve patients -

Exclusion Criteria:

1. Patients with respiratory co-morbidities. 2. Patients with other type of interstitial lung diseases. 3. Patients already taking steroids. 4. Pregnant or nursing female

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