cyrilzakka/clinical-trials huggingface dataset:
Efficacy of ICG-based NIR Imaging in Intralesional Curettage of Giant Cell Tumors of Bone in Limbs: a Prospective, Single-center, Single-arm, Open Study

ICG fluorescence imaging will be applied during the intralesional curettage of giant cell tumor of bone in the limbs. This study aims to preliminarily explore whether ICG fluorescent-guided curettage could find small residual tumors and reduce the recurrence rate of tumor.

Recurrence is a problem in the treatment of giant cell tumor of bone(GCTB). With the application of high-speed burr and other adjuvant therapy (phenol, liquid nitrogen freezing, cauterization, etc.), the recurrence rate is greatly reduced, but it is still as high as 20%. The main cause of local recurrence is the difficulty in distinguishing small residual tumor lesions by the naked eye. The application of frozen section is limited due to the long-term decalcification of bone specimens.

Intraoperative near-infrared (NIR) imaging is a promising technology expected to solve the above problems. It allows for real-time scanning of a wide area with tumor showing fluorescence. Such intraoperative fluorescent signals provide objective evidence for the surgeon and are more reliable than subjective visual and tactile information.

This study aims to explore whether ICG-based NIR imaging guided curettage could find small residual tumors and reduce the recurrence rate of GCT.

Eligibility Criteria:
Inclusion Criteria:

1. . Aged 18-65.
2. Biopsy confirmed giant cell tumor of bone.
3. The lesions located in the limbs.
4. This operation is the initial treatment.
5. Denosumab and diphosphonates are not used before surgery.
6. Planned operation is intralesional curettage and filling bone defects with bone cement.
7. Preoperative bone scan and thin layer (layer thickness ≤3.5mm) chest CT plain scan confirmed that the lesion is a single occurrence without metastasis.
8. Subjects fully understand the benefits and risks of this experiment and are still willing to participate and sign the informed consent.

Exclusion Criteria:

1. . Known allergy to iodine contrast, indocyanine green or bone cement.
2. . Severe hepatic and renal insufficiency.
3. . During pregnancy or lactation.
4. . Have other malignant tumors and are receiving related medical treatment.
Effects of Dietary Nitrate From Vegetable/Fruit Juice on Cerebral Blood Flow Parameters

Nitrate provides the body with an alternative source of Nitric Oxide which plays a large role in promoting blood flow and reducing blood pressure. Nitrate supplementation with vegetable/fruit juice has recently been shown to reduce blood pressure and reduce energy expenditure during low intensity exercise. Such findings combined with the previously known biological effects of nitric oxide would suggest that nitrate supplementation would also impact on blood flow. The aim of this study is to examine the effects of dietary nitrate supplementation via vegetable/fruit juice drink on cerebral (brain) blood flow (using Near Infrared Spectroscopy).


Eligibility Criteria:
Inclusion Criteria:

* healthy young (18-35 years) male and female adults, not vulnerable.

Exclusion Criteria:

* smoke or consume any tobacco products (even occasionally)
* not proficient in English
* pregnant (or are seeking to become)
* currently taking recreational, over the counter/prescription medication (excluding the contraceptive pill), and/or dietary/herbal supplements.
* any food allergies or sensitivities that are relevant to the study
* history of/current head trauma, learning difficulties, ADHD, dyslexia, migraines or any gastric problems.
Degarelix Neo-Adjuvant Radical Prostatectomy Trial

To assess the effect of neo-adjuvant GnRH antagonist, degarelix, versus LHRH agonist on intratumoral levels of androgens.


Eligibility Criteria:
Inclusion Criteria:

* Men \>18 and =\< 75 years of age
* Willing and able to provide informed consent, either alone or with the aid of a translator
* Histologically confirmed prostate cancer as determined by transrectal ultrasound (TRUS) guided prostate biopsy performed within 6 months of study enrolment
* Gleason Score \>= 7and/or prostate cancer that is clinical stage T2 disease.
* Candidates for open radical prostatectomy considered surgically resectable by urologic evaluation
* Normal organ and marrow function as defined by the following criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion Criteria:

* Previous or current use of hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, megestrol acetate, and ketoconazole)
* History of receiving radiation to the pelvic area.
* Previously received therapy with 5-alpha reductase inhibitors finasteride and/or dutasteride 4 weeks prior to randomization.
* History of bilateral orchiectomy, adrenalectomy, or hypophysectomy.
* History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
* Known hypersensitivity towards any component of the investigational medicinal product or Casodex (bicalutamide) or their excipients.
* Marked baseline prolongation of QT/QTcF interval (e.g. repeated demonstration of a QTcF interval \>450 ms).
* History of risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, or family history of Long QT Syndrome).
* Previous history or presence of another malignancy, other than prostate cancer or treated squamous / basal cell carcinoma of the skin, within the last five years.
* Clinically significant laboratory abnormalities (e.g. severe renal or hepatic impairment) which in the judgment of the Investigator would affect the patient's health or the outcome of the trial.
* Clinically significant disorder (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient's health or the outcome of the trial as judged by the Investigator.
* Use of natural medicines thought to have endocrine effects on prostate cancer (e.g. saw palmetto and St. John's Wort) 4 weeks prior to randomization.
* Mental incapacity or language barrier precluding adequate understanding or co operation.
* Use of an investigational drug within the last 28 days preceding the Screening Visit or longer if considered to possibly influence the outcome of the current trial.
* Previously participated in any degarelix trial.
Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease

The purpose of this randomised, double-blind, placebo-controlled, parallel group study is to assess the safety and efficacy of orally administered DS102 capsules versus placebo in the treatment of adult patients with Chronic Obstructive Pulmonary Disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* Patients (male or female) aged 40-75 years with stable COPD at the time of screening.
* Patients who are current or ex-smokers who have a smoking history of at least 10 pack years (Ten pack- years are defined as 20 cigarettes a Day for 10 years, or 10 cigarettes a Day for 20 years).
* Patients whose pre-study clinical laboratory findings do not interfere with their participation in the study, in the opinion of the Investigator.
* Patients who are able to communicate well with the Investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent.

Exclusion Criteria:

* Patients with a history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
* Patients with significant systemic or major illness other than pulmonary disease, including coronary artery disease, liver disease, cerebrovascular disease, renal insufficiency, serious psychiatric disease, respiratory or hypertensive disease, as well as diabetes and arthritis that, in the opinion of the Investigator, would preclude the patient from participating in and completing the study.
* Patients with known hypersensitivity to any ingredients of the study treatment.
* Patients, in the opinion of the Investigator, not suitable to participate in the study
Urine Sample Collection From FOP Patients

The purpose of this study is to collect urine samples from patients with fibrodysplasia ossificans progressiva (FOP) for the assessment of biomarkers related to disease, disease progression and for prediction of flare-ups of the disease. Disease related biomarkers in these patients are currently unknown. This study aims to support the development of novel therapy/ies for this disease.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ≥ 5 and ≤ 35 years of age with a diagnosis of FOP.
* Physically able to provide first-morning urine sample of at least 30 mL
* Able to communicate well with the investigator, to understand and comply with the requirements of the study
* About half of the patients enrolled should have a flare-up, which is defined as an acute exacerbation of disease activity characterized by two or more of the following symptoms: pain, swelling, decreased range of motion, impaired function

Exclusion Criteria:

* Diagnosis of diabetes
* Diagnosis of other systemic inflammatory disorder (juvenile idiopathic arthritis, systemic lupus erythematosus, etc.)
* Diagnosis of cancer other than nonmelanomatous skin cancer.
Telcagepant (MK-0974) Long-Term Safety Study in Adult Participants With Acute Migraine (MK-0974-012)

The purpose of this study is to investigate the safety and tolerability of telcagepant (MK-0974) in the long-term treatment of acute migraine in adult participants. The primary hypothesis of this study is that telcagepant is well tolerated in the long-term treatment of acute migraine in adult participants.


Eligibility Criteria:
Inclusion Criteria:

* At least 1 year history of migraine (with or without aura)
* Females of child bearing potential must use acceptable contraception throughout trial
* In general good health based on screening assessment

Exclusion Criteria:

* Pregnant/breast-feeding (or is a female expecting to conceive during study period)
* History or evidence of stroke/transient ischemic attacks, heart disease, coronary artery vasospasm, other significant underlying cardiovascular diseases, uncontrolled hypertension (high blood pressure), uncontrolled diabetes, or human immunodeficiency virus (HIV) disease
* Major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
* History of gastric, or small intestinal surgery, or has a disease that causes malabsorption
* History of cancer within the last 5 years
General Anesthetics-related Changes in Prefrontal EEG During Pediatric Surgical Anesthesia

The change profiles of indices derived from pEEG such as phase-amplitude coupling and bicoherence based on individual general anesthetics in children have not been examined in previous literature. Whether those indices have the abilities to predict individual drug-related anesthesia depth in children need to be explored.

The need to maintain a proper depth of general anesthesia during pediatric surgery is an important aspect of anesthesiology. An inappropriate anesthesia depth increases the risk of intraoperative awareness or delay in recovery in children undergoing surgery. Current modalities for anesthesia depth monitoring showed limited accuracy in children. The electroencephalogram (EEG) can be analyzed in its raw form for characteristic drug-induced patterns of change or summarized using mathematical parameters as a processed electroencephalogram (pEEG). The change profiles of indices derived from pEEG such as phase-amplitude coupling and bicoherence based on individual general anesthetics in children have not been examined in previous literature. Whether those indices have the abilities to predict individual drug-related anesthesia depth in children need to be explored.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 0-18 years, American Society of Anesthesiologists Physical Status I-II, scheduled for elective surgery in Peking University First Hospital.

Exclusion Criteria:

* Preterm patients;
* Height and weight not within the standard ranges for respective ages;
* Surgery for head or heart;
* Patients with muscular, neurologic or psychiatric diseases;
* Patients with Congenital anomaly or hereditary diseases;
* Patients with medication abuse;
* Allergy to medication including propofol, sevoflurane, and ketamine;
* Allergy to beans;
* Refusal to participate the study by guardians.
Effect of Phytalgic in Osteoarthritis (OA)

The objective of the study is to test the effects of a herbal supplement, Phytalgic, on the symptoms of osteoarthritis of the knee or hip, in patients with OA using NSAIDs or analgesics on a regular basis.


Eligibility Criteria:
Inclusion Criteria:

* knee or hip osteoarthritis
* regular NSAIDs/analgesic treatment
* signed inform consent

Exclusion Criteria:

* incapacity to understand study
* irregular NSAID treatment
The Use of an "Anal-Tape" in Patients With Fecal Incontinence

Fecal incontinence (FI), defined as the involuntary passage of stool for more than 3 months and is a devastating disease. The negative impact on quality of life has been consistently demonstrated. The prevalence of FI is probably underestimated in most studies. Currently conservative treatment is only modestly effective and surgical treatment is complex and expensive with less than optimal efficacy.

The investigators developed an "anal tape" using a commercially available elastic band with a special adhesive that is approved for use in the skin. A special design of the tape can be applied to the skin surrounding the anus providing support and additional pressure forces to the anal sphincter.

This is a 4 week, prospective, non blinded, cross-over study to explore the efficacy and safety of this device in patients with FI. The primary endpoint will be improvement in quality of life.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Fecal incontinence for more than 6 months
* Willing to participate
* Understand the study procedures
* Is able to apply and remove the "anal tape" without significant assistance of others.
* Have done sigmoidsocopy or colonoscopy and anal manometry within five year of screening visit

Exclusion Criteria:

* Advanced full thickness rectal prolapse.
* Injured, inflamed or any significant disease in the peri-anal skin.
* Allergy to any component of the device, either known or developed during testing in the screening visit.
* Moderate to severe proctitis of any etiology.
Sulphadoxine-Pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Uganda

The effectiveness of sulfadoxine-pyrimethamine (SP) as intermittent preventive treatment in pregnancy in malaria-endemic areas the effectiveness and efficacy of SP may be compromised by increased SP resistance. This study will evaluate the efficacy of SP by giving SP to asymptomatic parasitemic pregnant women and following them to determine the rates of parasite clearance.


Eligibility Criteria:
Inclusion Criteria:

* 16-26 weeks gestation based on LMP or ultrasound or fundal height
* Axillary temperature \<37.5 degrees C
* Informed consent
* HIV status known and negative
* Blood smear positive for falciparum malaria

Exclusion Criteria:

* History of hypersensitivity reaction to SP or components of SP
* Axillary temperature ≥37.5 degrees C
* History of receipt of antimalarials or antibiotics with antimalarial activity\* in the past month
* Residence \> 30 km from the ANC clinic or unwillingness to return for follow-up visits
* Hemoglobin level \< 5 gm/dL

  * These medications include all antimalarials, rifampin, doxycycline, clindamycin, tetracycline, erythromycin, azithromycin, chloramphenicol.
Augmented Pacing for Shock in the Cardiac Intensive Care Unit

The goal of this clinical trial is to learn if backup pacing at an increased rate improves hemodynamics in adults with relative bradycardia, a permanent pacemaker, and cardiogenic shock. The main question it aims to answer is:

Does increasing the backup pacing rate to 100 beats per minute lead to improved cardiac index compared to a backup pacing rate of 75 beats per minute

Participants who are already hospitalized in the Cardiovascular Intensive Care Unit with a permanent pacemaker and pulmonary artery catheter in place will be enrolled in this study. Participants will be exposed to each pacemaker rate in a randomized order with hemodynamics assessed after 10 minutes at each rate.


Eligibility Criteria:
Inclusion Criteria:

* Adults (age 18 and older)
* Located in the CVICU
* FDA approved permanent pacemaker in place (inclusive of dual-chamber and Bi-Ventricular ICDs) with labeling that allows backup pacing setting at 100 bpm.
* Receiving a vasopressor or Inotrope for at least 4 hours
* Average HR ≤ 75 bpm over the last hour (on Telemetry review)
* Pulmonary artery catheter in place with functioning thermistor and pulmonary artery port.

Exclusion Criteria:

* Single chamber Implantable Cardiac Defibrillator
* Sinus rhythm with a leadless pacemaker
* Ventricular Tachycardia or Ventricular Fibrillation arrest in last 48 hours
* Hemodynamic instability within the last 4 hours, defined as an increase in the dose of norepinephrine \> 10 mcg/min, an increase of epinephrine \> 10 mcg/kg/min, or initiation of a second vasopressor
* Alternative indication for pacing rate change (i.e Torsade de Pointes, Recurrent Ventricular Tachycardia)
* Comfort-focused care or anticipated death within 24 hours
* Mechanical circulatory support in place
* Newly discovered pacing system malfunction (lead displacement, loss of capture, elevated capture threshold, significant lead impedance change, battery depletion, undersensing or oversensing)
* Non-English Speaking
Probiotics: is it Really That Good? Cost-Effectiveness of Treating the in-Patient

Medical literature has dealt with various perspectives of probiotic therapy - prevention of antibiotic associated diarrhoea, Clostridium difficile, etc.

However, there have been no published results which can provide a basis for a generalized recommendation or discouragement of probiotic use among various groups of hospitalized patients.

The hypothesis is that the benefit in probiotic therapy in the admitted patient is by far larger than the actual cost of therapy. This assumption is probably true for all admitted patients and for patients on antibiotic therapy in particular.

Probiotics are known as a food supplement available worldwide as an OTC drug, with minimal side effects. Probiotics have also been recommended as a food supplement to patients suffering of antibiotic side effects and to those suffering of IBD or IBS.

All patients admitted to Internal Medicine and the Medical Intensive Care Unit will be randomly divided in a double blind fashion into two groups. Group One will be provided with the probiotic mixture - one capsule, two times per day. Group Two will receive a placebo. Group Three will receive no therapy.

Objective parameters such as duration of hospital stay, mortality and diarrhea frequency will be recorded. In addition, the frequency of CDT as well as blood and urine cultures will be examined. Furthermore, subjective measures will be examined by use of a questionnaire to be filled by the patient and/or his/her family members, or by the treating nurse.

Later the data will be processed and analyzed to compare between all the study participants and between the subgroups of the study (i.e. patients on specific antibiotic therapies).

For each patient, the experiment will last throughout his/her entire hospital stay.

The study is to last for one year and until 120 patients have participated.

Eligibility Criteria:
Inclusion Criteria:

* All patients hospitalized in the Department of Internal Medicine for a minimum duration of 3 days.
* Age (all \>18) and gender are to have no impact on the usage of the drug.

Exclusion Criteria:

* patients who do not agree to participate in the study
* patients on an NPO (nothing per os) order, if NPO includes medications
* patients who suffer of Celiac disease
The Influence of Gene Polymorphism on Clinical Outcomes in Patients Undergoing PCI

Dual antiplatelet therapy with aspirin and thienopyridines is an essential treatment in patients undergoing percutaneous coronary intervention (PCI). However, despite intensified antiplatelet treatment, some of the patients undergoing PCI develop thrombotic stent occlusion, suggesting incomplete platelet inhibition due to thienopyridine resistance. Some patients develop bleeding event because of the improper dosage and covariation. This observational study is designed for clarifying the Influence of gene polymorphism on clinical outcomes in patients undergoing PCI.

Patients undergoing PCI who received dual antiplatelet therapy with both aspirin (100mg) and P2Y12 inhibitors in standard dosage were enrolled. Investigators examined plasma biomarkers for platelet activation and DNA in those patients, and then analyzed the CYP2C19 genetic polymorphism to examine the influence of this genetic variation on the several biomarkers for platelet activation and bleeding event.

Eligibility Criteria:
Inclusion Criteria:

1. The patients undergoing PCI
2. More than 18 years old
3. Treated with aspirin and P2Y12 inhibitors (clopidogrel or ticagrelor)

Exclusion Criteria:

Inability to provide written informed consent
Inflammation and Postoperative Tramadol Analgesia

Patients will be admitted in the intensive care unit after major abdominal surgery. All patients will receive 100 mg of tramadol intravenously every 6 hours. Pain will be assessed before and half an hour after tramadol administration by verbal Numeric Rating Scale.

To all patients included in the study from the blood sample taken prior to the operation the leukocytes counts, c-reactive protein (CRP), procalcitonin (PCT) and lactate level will be performed, as well as arterial blood gas analysis.

After admission to the intensive care unit, all patients will receive 100 mg of tramadol intravenously every 6 hours. Pain will be assessed before and half an hour after tramadol administration by verbal Numeric Rating Scale (NRS). Pain score will be compared between patients with and without systemic inflammation. Systemic inflammation is defined as fulfilling at least two of the following major criteria: fever \> 38 oC or hypothermia \< 36 oC, tachycardia \> 90 beats/minute, pCO2 in arterial blood \< 4.3 kPa and leukocytes \> 12.000/mm3 or \< 4.000/mm3. Also, preoperative values of CRP \> 50 mg/L and PCT \> 0.5 ng/ml was also considered systemic inflammation.

Eligibility Criteria:
Inclusion Criteria:

* elective and emergency open abdominal surgery
* ICU admission

Exclusion Criteria:

* tramadol allergy
* surgery performed laparoscopically
* age younger of 18 years and older the 90 years