cyrilzakka/clinical-trials huggingface dataset:
A Urinary Tumor Marker (Kidney Injury Molecule-1) for the Detection of Renal Cell Carcinoma

The ultimate goal of this project is to develop a simple non-invasive method to screen patients for potential kidney tumors.

In the United States there were 38,900 cases and 12,840 deaths from renal cell carcinoma in 2006. Renal cell carcinoma represents 2% of all cancers worldwide. The majority of kidney tumors are discovered incidentally during investigation of unrelated complaints. However, nearly 30% of patients present with metastatic disease at the time of diagnosis and 30-40% of patients with clinically localized kidney cancer will have a recurrence. The diagnosis and monitoring of kidney cancer requires expensive and frequent imaging examinations. There is a significant need to find diagnostic and prognostic biomarkers to screen, diagnose, and monitor renal cancers.

A reliable urinary assay for kidney cancer would have major implications for tumor screening in high risk patients, in selection of patients for adjuvant therapy, in surveillance and prognosis and possibly as a surrogate marker for response to therapy. Human kidney injury molecule-1 (KIM-1) has been found to be a sensitive and specific biomarker in identifying kidney injury. The urine levels of KIM-1 are increased in the patients with kidney failure and major types of kidney tumors. The purpose of the study is investigate how urine KIM-1 and a routine blood marker for renal failure (creatinine) can distinguish kidney tumors from non-tumor kidney injury. The ultimate goal of this project is to develop a simple non-invasive method to screen patients for potential kidney tumors.

Eligibility Criteria:
Inclusion Criteria:

* Patients demonstrate normal serum creatinine and no radiological evidence of a renal tumor.

OR

* Patients diagnosed with renal cancer and normal creatinine.

Exclusion Criteria:

* None.
Octreotide in Severe Polycystic Liver Disease

This study will evaluate the effect of Octreotide LAR® on the liver volumes of patients with severe polycystic liver disease who are not candidates or decline surgical treatments such as liver cyst fenestration, liver resection or liver transplantation. A total of 42 patients will be recruited -14 who will receive placebo and 28 the study drug. Preliminary evidence indicates that this drug is safe and non-toxic in other disease states. Treatment with this drug holds promise not only for individuals with liver involvement, but also for many more patients with polycystic kidney disease.

The primary aim of this study is to compare the effect of Octreotide LAR® Depot on the liver volume of patients with severe polycystic liver disease who are not candidates or decline surgical treatments such as liver cyst fenestration, liver resection or liver transplantation compared with placebo. The secondary aims of the study are: (1)Assess the effect of Octreotide LAR® Depot on the total kidney volume and iothalamate clearance in patients with polycystic kidney disease associated with severe polycystic liver disease who are not candidates or decline surgical treatments such as liver cyst fenestration, liver resection or liver transplantation. (2)Evaluate quality of life changes associated with the administration of Octreotide LAR® Depot in these patients. (3)Assess toxicity of Octreotide LAR® Depot in patients with polycystic liver disease (PLD).

Note: Subjects who completed this 1 year randomized trial were offered enrollment into an open-label (all subjects received Octreotide) extension trial for an additional two years of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age - 18 years and older
* Diagnosis of Polycystic Liver Disease (PLD) associated with ADPKD or isolated Autosomal Dominant Polycystic liver Disease (ADPLD)
* Severe PLD defined as a liver volume greater than 4000 mL or symptomatic disease due to mass effects from hepatic cysts
* Not a candidate for or declining surgical intervention

Exclusion Criteria:

* Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception
* Creatinine greater than 3mg/dL or hemodialysis dependent
* Cancer or major systemic disease that could prevent completion of the planned follow-up or interfere with data collection or interpretation
* Uncontrolled diabetes mellitus as defined by blood glucose levels of greater than or equal to 250 mg/dL on 2 or more consecutive daily readings despite antidiabetic therapy
* Neurologic/psychologic conditions preventing appropriate informed consent
* Symptomatic gallstones or biliary sludge
* Variceal bleeding or hepatic encephalopathy within prior 30 days
* Uncontrolled hypertension (Systolic blood pressure greater than 160 mmHg; Diastolic blood pressure greater than 100 mmHg)
* Current, or prior use of somatostatin analogue (octreotide, lanreotide) in past 6 months
* History of significant adverse reaction to a somatostatin analogue
Evaluation of Navigation Assisted Reconstruction of Posttraumatic Zygomatic Deformity

Treatment of late deformities following fractures of the orbitozygomaticomaxillary complex can be considered a formidable challenge, even to the skilled surgeon. However, the development of Computer-Assisted Navigation technology Offers new opportunities in the treatment of such deformities. With the help of navigation system,pre- and intraoperatively,the objective of any supporting medical device for reconstruction of the orbitozygomaticomaxillary complex would be visualization of the real and desired positions of the zygoma. In this randomized controlled trial, the investigators would like to evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation.

Treatment of late deformities following fractures of the orbitozygomaticomaxillary complex can be considered a formidable challenge. Even to the skilled surgeon, over-or underestimation of the displacement is likely to occur, leading to an unsatisfactory result caused by over- or undercorrection.However,The development of Computer-Assisted Navigation technology Offers new opportunities in the treatment of such deformities. With the help of navigation system,pre- and intraoperatively,the objective of any supporting medical device for reconstruction of the orbitozygomaticomaxillary complex would be visualization of the real and desired positions of the zygoma. In this randomized controlled trial, we would like to evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation.

Eligibility Criteria:
Inclusion Criteria:

1. post-traumatic unilateral deformities of the zygomaticomaxillary complex
2. The interval after the primary injury should be more than 21 days
3. Meet the operation indication
4. Voluntarily join this study with informed consents

Exclusion Criteria:

1. Obviously asymmetric of craniofacial structure
2. Poor compliance of patient
3. Any other condition that do not fit to participate in the study
Awareness of Osteoporosis in Patients With Hyperthyroidism

Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Multiple sclerosis patients are at increased risk for developing osteoporosis. Identifying whether multiple sclerosis patients have information and awareness about this disease is crucial. This study is aimed to investigate awareness and knowledge of osteoporosis in patients with hyperthyroidism.

Osteoporosis is a common disease of bone loss. The reduced bone strength predisposes an increased risk for fractures in older individuals. It can affect people from different ethnicity. Many factors increase the risk of osteoporosis, including age, postmenopausal state, glucocorticoid use, low body weight calcium, vitamin D, immobility, and chronic inflammation. Patients with hyperthyroidism are at high risk of developing osteoporosis due to chronic inflammation and their medications. Patients' knowledge and awareness about osteoporosis are essential for early detection, implementation of lifestyle changes, and treatment compliance. This study aimed to investigate osteoporosis awareness and knowledge about osteoporosis in patients with multiple sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hyperthyroidism
* Must be between the ages of 18 and 99
* Must give consent to participate in the study

Exclusion Criteria:

• Not giving consent
The Efficacy of Vitamin K2 n Human Osteoporosis, Blood-vessel Calcification and Sclerosis

This study used the generally recognized as safe (GRAS) grade of Bacillus subtilis natto to produce Vitamin K2, Menaquinone-7(MK-7), via fermentation, for functional evaluation. There are four major objectives for this study: (1) bioavailability of calcium; (2) evaluation of bone density improvement; (3) evaluation of blood-vessel calcification and sclerosis improvement; (4) safety evaluation.


Eligibility Criteria:
Inclusion Criteria:

1. Men and non-pregnant women who are at least 20 years and under 75 years of age; and
2. Female subjects cannot be pregnant or breast feeding.
3. Patients who are, in the opinion of the Investigator, able to comply with the requirements of the study; and
4. Patients who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving study medication.

Exclusion Criteria:

1. Women who are pregnant, as determined by a urine pregnancy test, or breast-feeding.
2. Presence or history of congestive heart failure (NYHA class III/IV) within the prior 12 weeks.
3. Recent myocardial infarction (within the prior 12 weeks).
4. Unstable angina pectoris.
5. Known or suspected renal insufficiency defined as creatinine\>1.5mg/dl.
6. Known or suspected hepatic insufficiency defined as abnormal liver function tests (GOT/GPT) \>3x upper normal limit (i.e., 120 U/l).
7. Known hypomotility syndrome: (such as hypothyroidism or scleroderma).
8. Recent major trauma within the prior 12 weeks.
9. Recent surgery requiring anesthesia including coronary artery bypass graft (within 12 weeks).
10. Recent hospitalization (within 12 weeks)
11. Uncontrolled hypertension (defined as a systolic blood pressure\>180mmHg or a diastolic blood pressure \>105mmHg).
12. Uncontrolled hyperlipidemia (defined as total cholesterol\>240mg/dL or triglyceride \>200mg/dL).
13. Uncontrolled diabetes (defined as HbA1c\>7%).
14. Cigarette smoker (\>=1/day).
15. Acute infection requiring current antibiotic therapy.
16. Current use of anticoagulant medication (e.g., warfarin).
17. Recent or abrupt change (within 1 month) in usual diet.
18. Use of an investigational drug (within 30 days prior to enrollment).
19. Known allergies to the component of study medication
20. Patients have acute disease, and in the opinion of investigators, are not suitable to participate in this study.
Quantification of the Time and Effort Required for Peripheral Blood Stem Cell Collection -The European Perspective

This study aims to observe the effects of the availability of plerixafor on the time and effort associated with autologous peripheral blood stem cell collection.

This non interventional study will consist of two parts:

I. Retrospective study:

A medical record review will be conducted covering 200 patients file undergoing peripheral blood stem cell mobilization in some European centers.

II. Prospective study :Time/Motion evaluation of actual apheresis - 20 events each center The actual apheresis events will be measured in consecutive patients scheduled to be candidates for peripheral blood stem mobilization in the apheresis area of the hospital. Each apheresis will be considered as one event . Should the patient receive more than 1 apheresis, each apheresis will be considered as one different event.

Eligibility Criteria:
Inclusion Criteria:

Patients must satisfy the following for the part 1

* Oncology patients diagnosed with Non-Hodgkin lymphoma who are candidates for autologous hematopoietic stem cell transplantation (HSCT)
* A patient that fails to achieve a target CD34+\>20 cells/µl, before or on the first day of apheresis
* Age \> 18 years

Exclusion Criteria for the part 1

Patients with:

* Age \< 18 years;
* Primary diagnosis other than Non-Hodgkin lymphoma
* Undergone prior autologous hematopoietic stem cell transplantation (HSCT)
Breast Cancer During Pregnancy

Patients are managed clinically according to ad hoc standards and scientific knowledge by a multidisciplinary team. Clinical decisions are made after a patient physician discussion. Blood and tissue samples are collected. Diagnostic, obstetric management surgical treatment, systemic treatment, perinatal results and follow up data are collected.


Eligibility Criteria:
Inclusion Criteria:

* Patients with breast cancer diagnosed during pregnancy

Exclusion Criteria:

* Patients who refuse informed consent
Do Generic Volar Locking Plates Provide Similar Outcomes at a Reduced Cost?

Across orthopedics, the investigators will be using the generic volar locking plates for patients undergoing open reduction and internal fixation (ORIF) of the distal radius using a block schedule, meaning one month we the generic implants and one month we use conventional implants from the surgeon's brand of choice. At the end of each month the health system will switch which type of implants (generic vs. conventional) they will use at their facilities. From a quality perspective each patient will be monitored both short and long term for complication and reoperation. This will be done through chart review.

Patients will be consented to surgery per a standard surgical consent form. Six surgeons who regularly perform distal radius fracture (DRF) ORIF are included (five hand and one orthopaedic trauma fellowship-trained). Per the practice protocol, patients will either be treated with a generic plate or a brand name plate as described above. Ultimately, the decision to use a generic volar locking plate (VLP) is left up to surgeon discretion. All surgical and follow-up data will be collected. Implants used, age at time of surgery, weight, height, gender, race, ethnicity, comorbidities (diabetes, heart disease, etc.), complications including, but not limited to: readmission, reoperation, non-union, wound dehiscence, and lab tests will be collected. This will be evaluated all within 90 days following surgery. Implants will be cross referenced with the institution's data base to determine cost. All data will be collected on a secure server and be kept password protected. The primary outcome was 90-day postoperative complications (readmissions, reoperations, and mortality rates) by implant vendor type (generic vs. conventional). Secondary outcomes consisted of implant costs, estimated blood loss, and tourniquet time. An a priori power analysis was conducted to estimate the minimum sample size needed to adequately detect a difference in reoperation rates with a large effect size (Cohen's d=0.8). At a Type I error rate of 0.05, a power of 80%, and a 1:1 group allocation, the estimated sample size was 36 patients (18 generic VLPs vs. 18 conventional VLPs). Statistical significance was set to p≤0.05.

Eligibility Criteria:
Inclusion Criteria:

* Isolated distal radius fracture
* Treated surgically with a volar locking plate

Exclusion Criteria:

* Volar locking plate not used
* Additional fixation was used
* Polytrauma (non-isolated injury)
* Open fracture
* \<18 years old
Perioperative Three Dimensional Right Ventricular Function

This study addresses the influence of anesthesia induction, ventilation and influence of cardiac surgical procedures and cardio-pulmonary-bypass on right ventricular function. Influence on patient outcome is also studied. Three dimensional echocardiography is applied.


Eligibility Criteria:
Inclusion Criteria:

* informed consent given
* cardiac surgical procedure
* left sided cardiac surgery or bypass surgery, ascending aortic surgery, assist device implantation

Exclusion Criteria:

* pregnant patients
* contraindication for transesophageal echocardiography
Web-based Study for Cancer Survivors

In this parallel group study, participants were randomized to either 1 of 3 conditions (a) fruit and vegetable consumption, (b) dietary fat and added sugars, or (c) physical activity.

In this study, the investigators will evaluate the feasibility and preliminary results of a 3-month web-based lifestyle intervention 500 female cancer survivors.

Specific aim 1: to determine the rates of recruitment, retention, attendance, satisfaction, adverse events, and barriers to participation in the proposed intervention.

Specific aim 2: to determine whether a home-based intervention is associated with greater improvements in mean minutes of moderate to vigorous physical activity, diet quality, body size, constructs of Social Cognitive Theory, and health-related quality of life than participants randomized to a sedentary behavior reduction condition.

Eligibility Criteria:
Inclusion Criteria:

* Previously diagnosed with breast cancer;
* 18-80 years old at time of cancer diagnosis;
* English-Speaking;
* Have access to high-speed internet.

Exclusion Criteria:

* Be currently enrolled in another intervention study or recently completed a study promoting healthy lifestyle behaviors (diet and/or exercise).
* Participants answering 'Yes' to one or more of the questions on the physical activity readiness questionnaire (PAR-Q) will need to obtain approval from a physician before they can participate in the intervention.
* Pregnant women will be excluded from the protocol.
Effects of Kinesiotaping and Electrical Muscle Stimulation on Low Back Pain and Disability

To compare the effects of kinesiotaping and electrical muscle stimulation on low back pain and disability associated with diastasis recti.


Eligibility Criteria:
Inclusion Criteria:

* Diastasis recti more than 2 or 2.5cm
* 6 weeks' postpartum cesarean section females
* Primigravida females
* Low back pain due to DR

Exclusion Criteria:

* Normal vaginal delivery
* Episiotomy
* Multigravida women's
* History of abdominal hernia
* History of any abdominal surgery
So-Lo-Mo Intervention Applied to the Smoking Cessation Process

This is a randomized open-label parallel-group trial. 240 subjects will be recruited during 8 months and a 12 months follow-up will be carried out for each one of them. The sample will split in two groups: control group (n=120) who will receive usual psycho-pharmacological therapy and the intervention group (n=120) who will receive usual therapy plus So-Lo-Mo app.

The main objective of this study is to analyze the efficacy and efficiency of the So-Lo-Mo intervention applied to the smoking cessation process compared to usual care.

Secondary objectives are:

1. To monitor usual psycho-pharmacological therapies (bupropion, varenicline and behavioural therapy).
2. To monitor healthy lifestyle and physical exercise habits.

Eligibility Criteria:
Inclusion Criteria:

* Smoking population attending to the Smoking Cessation Unit of "Virgen del Rocío" University Hospital.
* Subjects \>18 years old who want to give up smoking.
* Android-based smart phone availability.
* Ability to interact with the smart phone.
* To sign an Informed Consent Form.

Exclusion Criteria:

* Subjects had some previous adverse effects related to the pharmacological treatment included in the study
Abscopal Effect of Radiotherapy and Nivolumab in Relapsed Hodgkin Lymphoma After Anti-PD1 Therapy

The aim of the trial is to improve efficacy of nivolumab in patients with relapsed or refractory HL who recently progressed on anti-PD1 therapy. Nivolumab is highly effective and well tolerated in rrHL, nevertheless CR-rates are low and a considerable proportion of patients suffers from progressive disease. Localized RT induces an immunogenic effect which might work synergistically and facilitate augmented systemic (i.e. abscopal) responses in combination with nivolumab.


Eligibility Criteria:
Inclusion Criteria:

* Progression of refractory or relapsed cHL during treatment with an anti-PD1 agent
* At least two distinct FDG-avid HL-lesions with at least 5 cm distance between them, and one of them considered eligible for irradiation with 20Gy based on localization and prior RT exposure
* Age at registration ≥ 18 years

Exclusion Criteria:

* Nodular-lymphocyte predominant HL (NLPHL) or composite/greyzone lymphoma
* Lymphoma involving the central nervous system
* Naïve to treatment with anti-PD1 targeting antibodies
Remimazolam in the Extraction of Impacted Wisdom Teeth

Benzodiazepines, represented by midazolam, are often used for sedation in outpatient surgery in dentistry. However, midazolam has the problems of slow consciousness recovery and long recovery time, which brings trouble to the patients. Remimazolam is a new type of ultra short acting sedative anesthetic. Compared with other similar products, remimazolam has faster effect, rapid metabolism and has no accumulation, which may mean that compared with midazolam, remimazolam has a better clinical application prospect in dental outpatient surgery.

The patients were randomly divided into midazolam group and remimazolam group. The onset time of drugs, postoperative recovery time, vital signs, anterograde amnesia and other complications were observed.

Eligibility Criteria:
Inclusion Criteria:

Consenting patients will be eligible if they:

1. Have mandibular impacted wisdom teeth that need to be extracted;
2. Have a body mass index (BMI) between 18.5 and 30 kg/m2;
3. Are aged between 18 and 60 years;
4. Have American Society of Anesthesiology (ASA) classification grade of I-II;
5. Have Modified Dental Anxiety Scale (MDAS) score \> 15; and
6. Volunteered to accept intravenous sedation.

Exclusion Criteria:

Patients will be ineligible if they:

1. Are pregnant;
2. Experience respiratory infections, asthma attack or persistent state;
3. Have contraindications to anaesthesia or a previous abnormal surgical anaesthesia recovery history;
4. Have severe cardiopulmonary insufficiency;
5. Have preoperative blood pressure \> 160/100 mmHg or diastolic blood pressure \> 100 mmHg, or blood pressure \< 90/60 mmHg;
6. Have a neuromuscular or mental disorder that renders them unable to communicate or cooperate effectively or sign informed consent;
7. Are suspected of abusing narcotic analgesics or sedatives;
8. Have a known allergy or contraindication to benzodiazepines; or
9. Have participated in other drug trials within 6 months.