cyrilzakka/clinical-trials huggingface dataset:
Assessment of Bone Biomarkers for TKI Response in RCC With Bone Metastases, HRQoL and Comparison of Imaging Techniques

Prospective observational study to assess bone predictive biomarkers for TKI response in RCC patients with bone metastasis and HRQoL with TKI in these patients as well as the sensitivity and specificity of whole body magnetic resonance versus bone scintigraphy and versus CT in the assessment of metastatic lesions at bone level and at other sites.

Prospective observational study to assess:

* Bone predictive biomarkers for tyrosine kinase inhibitor (TKI) response in renal cell carcinoma (RCC) patients with bone metastasis - Health Related Quality of Life (HRQoL) with TKI
* Comparison of the sensitivity and specificity of whole body magnetic resonance versus bone scintigraphy and versus Computerized tomography (CT) in the assessment of metastatic lesions at bone level and at other sites.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a stage IV renal cell carcinoma with confirmed presence of bone metastases, subsidiary of treatment with an TKI in first line
* 18 years old or more
* Life expectancy \> 12 weeks
* Eastern Cooperative Oncology Group Performance Status (ECOG PS): 0 - 2
* Capability of understanding the study and completing the numerical pain scale, diary of analgesics and Quality of Life forms
* Patient who has given informed consent
* Adequate renal, hepatic and hematologic functions

Exclusion Criteria:

* Pregnancy, breastfeeding or fertile patients who do not use adequate contraceptive methods
* Non-clear cell histology
* Non irradiated brains metastases
* Symptomatic brain metastases
* Inability to undergo any of the medical tests of the study
* A history of breast cancer or melanoma. Other tumors are accepted as long as the patients has been for at least 5 years free of disease
* Synchronic diagnosis of another neoplasm
* Presence of an active infection
* Any decompensated disease or metabolic disorder
* Cardiac events or pulmonary embolism in the 12 months previous to inclusion
The Effect of Constructing Virtual Patient Cases

The aim of the study was to explore the effect of actively constructing Virtual patient (VP) cases compared with solving VP cases using 'Web-SP', Stockholm University, Stockholm, Sweden on knowledge gains and skills transfer in a group of pre-clerkship medical students.

Solving VP cases is associated with large improvements in learning but its effectiveness is dependent on active student involvement. Constructing VP cases rather than solving them may engage students more actively in encoding new information and integrating it with previous knowledge.

Fourth-year medical students were included and randomized to constructing (intervention) or solving (control) four cardiopulmonary VP cases. The participants were presented with a short case overview. The control group solved the cases, whereas the intervention group also received the final diagnosis and had to complete the history, physical findings, and lab results. After a week, participants completed a transfer test involving two standardized patients presenting a respiratory case and a cardiology case, respectively. Performances were video-recorded and subsequently assessed by two blinded raters using the Reporter-Interpreter- Manager-Educator (RIME) framework. Knowledge gains were assessed using a pre- and post-test of a 95-item Multiple-Response-Questionnaire (MRQ).

Eligibility Criteria:
Inclusion Criteria:

* fourth-year medical students, University of Copenhagen
* pre-study participation in the mandatory patient encounter skills course

Exclusion Criteria:

* medical students who had taken the three pre-clerkship years at other universities, because of curriculum discrepancies
Randomized, Blinded, Sham-controlled Trial of Acupuncture for the Management of Joint Pain in Patients With Psoriasis

The purpose of this study is to determine whether acupuncture is helpful for patients with joint pain associated with psoriasis

In this study, patients with psoriasis and joint pain will receive either real acupuncture or sham acupuncture to see if acupuncture can be an effective treatment of joint pain in patients with psoriasis.

Eligibility Criteria:
Inclusion Criteria:

* Plaque psoriasis
* Pain from at least two peripheral joints and/or inflammatory back pain
* No or stabile treatment of the psoriasis the last 3 months
* No or stabile pain treatment the last 3 months
* Oral and written information given
* Written consent signed

Exclusion Criteria:

* Arthritis with Ultrasound verified intra articular fluid og clinical verified joint swelling
* Pregnancy og breastfeeding
* Previous treatments with acupuncture
* Treatment with anticoagulants (vitamin K-antagonists, low molecular weight heparin, unfractionated heparin, direct thrombin inhibitors, direct factor Xa inhibitors)
* Unwilling to follow protocol
Evaluation of the Contribution of Lower Limb And/or Abdominal Compression on Orthostatic Hypotension

Orthostatic hypotension (OH) is associated with an increased risk of myocardial infarction, stroke, heart failure and neurocognitive disorders. In the elderly, OH is an independent predictor of falls and mortality. Non-drug treatments are used as the first-line treatments. Among non-drug treatments, compression of the lower limbs and abdominal compression have been shown to help reduce OH and associated symptoms. As these studies were solely based on ankle-to-thigh bandages, the effectiveness of other medical devices developed, such as compression socks and tights, needs to be evaluated. In addition, data comparing the efficacy and tolerability of several approaches, single or combined, of several levels of compression, provided by socks, tights and an abdominal belt are scarce. The HYPOFLEX study aims to provide new data to enable better management of OH.

Patients will be recruited from a single center, over a 12-month inclusion period. The clinical investigation will focus on CE-marked Class I medical devices, used for their intended purpose, as part of a post-market clinical follow-up with additional non-invasive, non-invasive procedures. Randomization will be carried out to determine the order of the 5 conditions studied:

* No compression,
* Class 2 compression socks,
* Class 3 compression socks,
* Class 2 compression tights,
* Dynabelt abdominal belt + Class 2 compression socks. Conditions will be tested over half a day.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 60 or over,
* Patients hospitalized at Broca Hospital with orthostatic hypotension,
* Patient able to stand,
* Patient who has been medically stable for at least 48 hours,
* Patient whose measurements are compatible with Thuasne compression device sizes,
* Patient having been informed, having received answers to his questions and having signed the informed consent form prior to his participation in the study,
* Patient affiliated or entitled to a social security number.

Exclusion Criteria:

* Patients presenting, according to the investigator, a contraindication to lower limb and/or abdominal compression,
* Patients presenting any contraindication mentioned in the instructions for use of the medical devices under investigation.
* Patient presenting, according to the investigator, a major cognitive impairment incompatible with participation in a clinical trial,
* Patient taking part in another clinical investigation conducted to establish the conformity of a medical device having an impact on the outcomes,
* Vulnerable patient according to article L1121-6 of the Public Health Code, subject to a judicial protection measure or incapable of consenting to a clinical trial or incapable of giving informed consent.
Evaluation of Apical Root Resorption in Dental Deep Bite Correction by Twin Slot Orthodontic Bracket

Evaluate the possible apical root resorption during deep bite correction by double slot bracket with low level slot versus high level slot using CBCT.

Group (A): Patients will be treated with double slot brackets using low level slot in deep bite correction. Group (B): Patients will be treated with double slot brackets using high level slot in deep bite correction.

Eligibility Criteria:
Inclusion Criteria:

1. Female patients to avoid any sexual dimorphism which may affect the comparison.
2. Age range from 18 to 23year.
3. Patients with anterior dento alveolar deep bite.
4. Angle class I or class II malocclusion with minimal crowding.
5. Healthy compliant and motivated patient.
6. No missing of any tooth except wisdom teeth

Exclusion Criteria:

* 1. Previous orthodontic treatments. 2. Any systemic or bone diseases. 3. Pregnant and lactating patient. 4. Prosthetic replacement in lower anterior teeth. 5. periodontitis with pocket depth more than 5 mm
The Ameliorative Effects of GLP-1RA on Diabetic Cardiac Autonomatic Neuropathy

Diabetic cardiac autonomic neuropathy (DCAN) is a common chronic complication that reduces survival in patients with diabetes. Epidemiological surveys have shown that the prevalence of DCAN is 25-75% in people with type 2 diabetes. The onset of DCAN is insidious and easy to be ignored in the early stage. With the progression of the disease, the following clinical symptoms gradually appear, including reduced heart rate variability, exercise intolerance, resting tachycardia, orthostatic hypotension, painless myocardial infarction and even sudden death, which seriously endanger the life and health of type 2 diabetes patients. Existing literature has shown that glucagon-like peptide-1 receptor agonist (GLP-1RA) can improve diabetic peripheral neuropathy and diabetic cognitive dysfunction, but there are few studies on improving diabetic autonomic neuropathy. Insulin resistance is an important risk factor for DCAN. Patients with type 2 diabetes are characterized by insulin resistance, and GLP-1RA is recognized as a drug to improve insulin resistance and control blood sugar in patients with diabetes. In this study, GLP-1RA was used to intervene patients with type 2 diabetes, and the changes in blood sugar control and insulin resistance status of patients were followed up. Special attention was paid to the improvement of autonomic neuropathy in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18-70 years
2. Patients with T2DM who meet the diagnostic guidelines
3. The patient signed the relevant informed consent form
4. Being overweight or obese

Exclusion Criteria:

1. \<18 years old
2. Pregnant or lactating women
3. Acute and chronic pancreatitis
4. Recent acute complications of diabetes
5. Arrhythmia or taking drugs that affect heart rate
6. Thyroid disease
7. Severe organ dysfunction
8. Denial of informed consen
Detection of CTCs in Stage III Rectal Cancer Patients Undergoing Neoadjuvant Therapy

The purpose of this study is to evaluate the value of dynamic change in detecting CTCs in peripheral blood from stage III rectal cancer patients undergoing neoadjuvant Folfox treatment and chemoradiotherapy,before and after surgery.

Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time biopsy' of tumor biological activity. Enumeration of CTCs in rectal cancer patients could play an important role in diagnosis, predicting the risk for tumor recurrence and effectiveness of neoadjuvant therapy.

The investigators choose several timepoints to detect the dynamic change of CTCs,1 day before the 1st ,3rd and 5th(if the patient needs before surgery) neoadjuvant therapy course,1 day before and 7days ,3 month,6 month after surgery. Approximately 7.5-mL ethylene diamine tetraacetic acid(EDTA)-blood was drawn by vein puncture from patients with rectal cancer . Briefly, the number of CTCs will be count by the cellsearch system , recorded and analysed by the investigator.

Eligibility Criteria:
Inclusion Criteria:

1. Age: \>18 years old.
2. Diagnosis of stage III rectal cancer based on histology.
3. Will receive neoadjuvant treatment using Folfox or chemoradiotherapy .
4. Life expectancy: Greater than 3 months.
5. Patients have no severe inflammation, such as vasculitis.
6. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other primary tumor except rectal cancer.
2. History of coagulation disorders or anemia.
I-ACT With Check Yourself

Adolescents have some of the highest rates of risk behaviors of all age groups and health behaviors developed in adolescence can persist into adulthood. These behaviors carry significant risks for subsequent disease, disability, and healthcare burden. Despite these risks, health risk screening in primary care is infrequently performed and results are rarely followed by targeted intervention. In response to the need for screening-linked interventions, our study team has developed a web-based, electronic Personalized Motivational Feedback tool which we refer to as "Check Yourself." Based on motivational interviewing, a technique to mobilize personal change, Check Yourself is designed to promote healthy choices for the multiple behaviors relevant to adolescents as well as to provide information to providers to promote discussions around health behaviors between providers and adolescents.

Building on electronic health interventions, primary care providers can play an essential role in helping adolescents to make healthy behavior choices. Emerging evidence suggests that the consistency of preventive counseling can be increased through provider training and the provision of screening tools; yet, we know very little about the quality of such counseling, and if it impacts outcomes that are important to adolescent patients themselves.

This study is a stepped-wedge, controlled trial comparing the effectiveness of an interactive adolescent-centered training for primary care providers (I-ACT) and Check Yourself to usual care. This study will take place in six pediatric practices. The purpose of this study is to determine whether this system of interventions (i.e., I-ACT, Check Yourself, and the summary report) is more effective than usual care in reducing health risk behaviors, improving adolescent motivation for health, and improving quality of care among adolescents receiving primary health care services.


Eligibility Criteria:
Inclusion Criteria:

* Eligible adolescent participants will be 13-18 years of age and caregiver participants will be 18 years of age or older and able to understand English. Eligible participants will have an appointment (or have a child with an appointment) with a participating medical practice.

Exclusion Criteria:

* Adolescents will be excluded from the study if they do not meet age requirements, do not have an appointment with a participating provider at a PSPRN clinic, lack the means to complete follow-up interviews (i.e., have neither telephone nor internet access), have a sibling who has been/is being enrolled in the study or have previously participated in our previous trial comparing Check Yourself to usual care, and/or are not able to understand English.
* Caregivers will be excluded from the study if they do not speak English; or if their child is not eligible or declines to participate in the study .
Dose-Titration Study of Sevelamer Carbonate in Chronic Kidney Disease (CKD) Patients on Hemodialysis

The study aims to evaluate the efficacy and safety of sevelamer carbonate in reducing serum phosphorus and serum lipids (total and LDL-cholesterol) in Chronic Kidney Disease Patients on dialysis.


Eligibility Criteria:
Inclusion Criteria:

* On hemodialysis regimen scheduled for four hour duration three times per week for a minimum 30 days prior to Visit 1 and throughout the study
* Have a central laboratory serum iPTH measurement less than 1000 pg/mL at Visit 1
* Have a central laboratory serum phosphorus measurement greater than 5.5 mg/dL at Visit 1a

Exclusion Criteria:

* Active dysphagia or swallowing disorder; or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal (GI) motility disorders including severe constipation
* Documented poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, human immunodeficiency virus infection, or any clinically significant unstable medical condition
Safety and Efficacy of the Sterile Single-use Circular Stapling Device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China)

Evaluation of the safety and efficacy of the sterile single-use circular stapling device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China) in comparison with circumcision in adults patients with pathological foreskin (phimosis, stenosis, redundant prepuce)


Eligibility Criteria:
Inclusion criteria :phimosis, stenosis of foreskin, redundant prepuce

Exclusion criteria : active inflammation of foreskin
Biomarker for Rapid Diagnosis of Hemispheric Stroke

The aim of the study is to estimate the diagnostic accuracy of a combined biomarker test (including NMDA-Receptor fragments \[NR2-peptide\] and Glial fibrillary acidic protein) used to differentiate between cerebral ischemia and intracerebral hemorrhage in patients with acute hemispheric stroke.


Eligibility Criteria:
Inclusion Criteria:

* hemiparesis
* at least one sign of cortical involvement (e.g., aphasia, neglect, gaze deviation, reduced level of consciousness)
* hospital admission within 4.5 hours after symptom onset

Exclusion Criteria:

* stroke/TIA within the last 3 months
* traumatic brain injury within the last 3 months
* history of brain tumor
HIV Study on MEasuring the Reservoir on Cellular Level to CUre Infection

The aim of this study is to gain new insights into HIV latency and reversal through extensive blood and tissues sampling (lymph node and colon biopsies) from 25 individuals under ART.


Eligibility Criteria:
Inclusion Criteria:

* Documented HIV-1 subtype B infection
* Able and willing to provide written informed consent
* Age = or \>18 years and \< 65 years
* CD4 count at screening \> 350/μl
* Viral load \< 40 copies/ml determined by CobasTaqMan HIV-1 test v2.0 assay for at least 2 years (one blip \< 200 copies/ml is allowed)
* Ability and willingness to have blood and tissue samples collected and stored for 20 years and used for various research purposes.

Exclusion Criteria:

* Previous or current history of opportunistic infection (AIDS defining events as defined in category C of the CDC clinical classification), consisting of chronic HIV-1 infection.
* Evidence of active HBV infection (Hepatitis B surface antigen positive or HBV viral load positive in the past and no evidence of subsequent seroconversion (=HBV antigen or viral load negative and positive HBV surface antibody)).
* Evidence of active HCV infection: HCV antibody positive result within 60 days prior to study entry with positive HCV viral load or, if the HCV antibody result is negative, a positive HCV RNA result within 60 days prior to study entry.
* Current or known history of cardiomyopathy or significant ischemic or cerebrovascular disease.
* Current or known history of cancer.
* History of HIV-related thrombocytopenia.
* Pregnancy or breastfeeding.
* Any conditions, including preexisting psychiatric and psychological disorders, which will in the opinion of the investigator interfere with the trial conduct or safety of the participant.
* Previous participation in a trial evaluating an immune modulating agent.
* Abnormal results of standard of care laboratory tests:

  1. Confirmed haemoglobin \<11g/dl for women and \<12 g/dl for men
  2. Confirmed platelet count \<100 000/µl \*
  3. Confirmed neutrophil count \<1000/μl
  4. Confirmed AST and/or ALT \>10xULN
* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Acute or serious illness, in the opinion of the site investigator, requiring systemic treatment and/or hospitalization within 60 days prior to entry.
* The following treatment will be prohibited three months before screening and during the study:

  1. immunosuppressive drugs (inclusive corticosteroids) except for drugs used for topical use.
  2. Immunomodulatory drugs including but not limited to Granulocyte-colony stimulating factors, Granulocyte-monocyte colony-stimulating factor, interleukin 2, 7 \& 15.
Screening for TB in Pregnancy. on HIV-Infected Pregnant Women

Pregnant women who develop active Tuberculosis (TB) are at increased risk of poor maternal and infant outcomes. Our data from South Africa show that up to 3% of HIV-infected pregnant women have active TB , many with advanced disease, contributing to the 40% of maternal mortality associated with TB or HIV in South Africa . Screening for TB in pregnant women in this setting is therefore essential to reduce maternal mortality. Symptom-directed screening for TB has been recommended by the World Health Organization and by the South African National Department of Health; however, no implementation framework is in place to operationalize the guidelines. Symptom-based testing is an efficient process that limits use of diagnostic tests, but may miss many cases. In Soweto, we found that 0.7% (700/100,000) of HIV-infected women had active TB when a symptom-based strategy was employed once, but in Klerksdorp we found that 3.3% (3,300/100,000) had active TB when universal testing, regardless of symptoms, was performed; most TB cases were newly diagnosed among women who reported no symptoms .


Eligibility Criteria:
Inclusion Criteria:

1. HIV seropositive by two rapid tests, or documented history of a positive Enzyme Immunoassay EIAs, or HIV RNA \>1000 copies/mL
2. Pregnancy confirmed by urine pregnancy test or clinical exam
3. Estimated gestational age of 13 weeks or older
4. Age 18 years or greater
5. Willing to provide verbal consent

Exclusion Criteria:

1. Currently diagnosed with TB
2. Completed TB treatment within the last 6 months
3. Inability to communicate in one of the study languages.
4. Lack of comprehension of the study based on inability to meet basic understanding questions during the screening process.