cyrilzakka/clinical-trials huggingface dataset:
Thermal Insulation System in Inadvertent Hypothermia

This study compares the effectiveness of a new layered thermal insulation system (SIT-3c) versus the traditional thermal body protection (warmed forced air system) for patients under total knee arthroplasty, during the intra-operative phase.

Protecting patients from the cold in the operating room is a complex problem that has encouraged the search for better and more effective thermal protection systems. Some disadvantages have been observed in the daily use of the recommended thermal protection system (forced warm air).

This study intends to design and evaluate the effectiveness of a three-layer thermal insulation system, comparing its effect with the forced warm air system on temperature variation, shivering incidence and comfort perception, in patients undergoing total knee arthroplasty under neuro-axial anesthesia, during the intra-operative phase.

Participants are randomly assigned to the experimental group (EG) or control group (CG). The experimental group receives as a skin protection the three-layer thermal insulation system (SIT-3c) and the control group receives the usual recommended system (forced warm air).

Both systems are placed at the entrance to the operating room and held on patients during the entire intra-operative phase.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years, with the diagnosis of gonarthrosis, to undergo total elective knee arthroplasty, under neuroaxial anesthesia, who agreed to participate in the study.

Exclusion Criteria:

* With hypothermia or hyperthermia, scheduled for general anesthesia, pregnancy
Prevention of Persistence of Bacterial Vaginosis

This purpose of this study will be to conduct a double-blind, randomized, controlled clinical trial to determine the association between intravaginal high dose metronidazole (750mg), intravaginal high dose metronidazole combined with an antifungal agent(750mg metronidazole + 200mg miconazole) and low dose (37.5mg) intravaginal metronidazole, with the rate of persistent bacterial vaginosis.


Eligibility Criteria:
Inclusion Criteria:

* women 18-40 yrs old
* abnormal vaginal discharge or malodor
* positive QuickVue test
* positive KOH whiff test
* Positive finding of clue cells greater than or equal to 20% on wet mount
* Able to give informed consent
* willing to abstain from alcohol during the 5 day therapy and 1 day following

Exclusion Criteria:

* immunocompromised women
* symptomatic VVC
* pregnancy or positive pregnancy test
* menstruating or breastfeeding women
* other oral or vaginal antifungal or antimicrobial drugs w/in past 2 wks
* women with MPC, PID
The Role of Intestinal and Vaginal Microbiota, Estrogenic Activity, Metabolic Profile & Nutritional Status in Endometriosis

Endometriosis (EMs) is one of the most prevalent benign gynaecological diseases, and it is an inflammatory oestrogen-dependent condition. Several authors have proposed that anatomical, genetic, endocrine, immunological, environmental, hormonal, and inflammatory factors may influence tissue implantation outside the uterus. An approach to EMs aetiology that involves defining a profile to the vaginal and gut microbiota, estrogenic activity, and exposure to xenoestrogens and also metabolic and nutritional status of women with EMs may help identify some important patterns to better characterize this disease and also to define more personalized nutritional strategies, also predicting patients' predisposition to therapy success. This is an observational study on premenopausal woman, diagnosed with EMs, who will be recruited on the outpatient gynaecology appointment, to evaluate the vaginal and intestinal microbiome, measure the total estrogenic activity, assess the metabolic biomarkers and the nutritional status.


Eligibility Criteria:
Inclusion Criteria:

* Premenopause;
* Diagnose of endometriosis by clinical and/or imaging criteria (associated adenomyosis is accepted);
* BMI between 18.5 and 30.0 kg/m2

Exclusion Criteria:

* Postmenopause;
* Vegetarian diet;
* Pregnancy or breastfeeding;
* Continuous hormonal therapy for endometriosis;
* Laparoscopic surgery for endometriosis purpose;
* Gastrointestinal or vaginal infections;
* Intaken antibiotics and/or probiotics within the last 8 weeks;
* Medications to treat vaginal infections in the past 3 months.
A Phase 2 Safety and Exploratory Skin Lesion Measurement of TR-701 FA Study

Characterization of the safety profile of TR-701 Free Acid (FA) in patients with major cutaneous abscess or cellulitis/erysipelas.

This is an open-label, multicenter study of oral TR-701 FA 200 mg once daily for 6 days for the treatment of major cutaneous abscess or cellulitis/erysipelas in patients 18 years of age or older. This study is designed to further characterize the safety profile and gather additional lesion measurement data of TR-701 FA in patients with major cutaneous abscess or cellulitis/erysipelas.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥ 18 years of age
* Suspected or documented gram-positive infection from baseline Gram stain or culture.
* Cellulitis/erysipelas or major cutaneous abscesses at Screening

Exclusion Criteria:

* Postsurgical or open wound infections
* Severe sepsis or septic shock
* Uncomplicated skin and skin structure infections such as furuncles, minor abscesses (\< 75 cm2 or area of suppuration not surrounded by cellulitis/erythema), and impetiginous lesions
* Infections associated with, or in close proximity to, a prosthetic device
* Known bacteremia or osteomyelitis at time of screening
Ofatumumab as Front-Line Therapy in Treating Elderly Participants With Chronic Lymphocytic Leukemia

This phase II trial studies how well ofatumumab works as front-line therapy in treating elderly participants with chronic lymphocytic leukemia. Monoclonal antibodies, such as ofatumumab, may interfere with the ability of cancer cells to grow and spread.

PRIMARY OBJECTIVES I. To evaluate the overall response rate of ofatumumab in the upfront setting in elderly, unfit patients with chronic lymphocytic leukemia (CLL).

SECONDARY OBJECTIVES:

I. To determine the overall survival with ofatumumab in upfront setting in elderly, unfit CLL patients.

II. To evaluate the complete response rate and time to progression to therapy of ofatumumab in elderly, unfit patients with CLL.

III. To determine the plasma levels of ofatumumab in elderly, unfit patients. IV. To evaluate predictive capability of micro ribonucleic acid (RNA) (miRNAs) detection in plasma samples.

OUTLINE:

Participants receive ofatumumab intravenously (IV) over 4 hours once a week for 4 weeks, then monthly thereafter. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic lymphocytic leukemia requiring treatment at the time of signing informed consent.
* Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 2-3 and a Cumulative Illness Rating Scale (CIRS) or Charlson co-morbidity score of 2 or higher.
* Creatinine \< 2mg/dL.
* Estimated glomerular filtration rate (eGFR) more than 30cc/minute.
* Bilirubin \< 2mg/dL.
* Patients with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman.
* Patients with Gilbert's syndrome are eligible.

Exclusion Criteria:

* Patients with documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).
* Known positivity for human immunodeficiency virus (HIV).
* Hepatitis B (HB) defined as a positive test for hepatitis B surface antigen (HBsAg). In addition, if negative for HGsAg but hepatitis B core antibody (HBcAb) positive (regardless of HBsAb status), a HB deoxyribonucleic acid (DNA) test will be performed and if positive the subject will be excluded.
* Prior treatment for chronic lymphocytic leukemia.
* Concurrent chemotherapy, radiotherapy, or immunotherapy, including other monoclonal antibodies. Localized radiotherapy to an area not compromising bone marrow function does not apply. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received.
* Any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the study.
* Any known hypersensitivity to ofatumumab or its components.
Tranexamic Acid for Preventing Progressive Intracranial Haemorrhage in Traumatic Brain Injury

The study's objective is to evaluate the effectiveness and safety of tranexamic acid for adult patients with moderate to severe TBI.With the research question as "Does TXA reduce the incidence of progressive intracranial haemorrhage by 50% compared to placebo in moderate to severe adult TBI patients at Khon Kaen Hospital?"

Traumatic brain injury (TBI) is a major public health problem with poor outcome especially with progressive intracranial haemorrhage (PIH) in severe patients. There are links between coagulopathic change after brain injury and delayed traumatic haemorrhage revealed by CT brain. Antifibrinolytic treatment can reduce blood loss after surgery and perhaps in moderate to severe TBI by similar haemostatic responses. It is justified to determine benefit for reversing hyperfibrinolysis after TBI. Tranexamic acid (TXA) has been shown to have significant clinical benefit in effectively reducing surgical bleeding in systematic reviews. It has been shown to have no effect on coagulation parameters and no demonstrated harmful effect in systematic reviews. This study is designed to determine the effectiveness of TXA in preventing PIH in patients with moderate to severe TBI. The treatment regimen if effective can be applied in general trauma practice worldwide.

Eligibility Criteria:
Inclusion Criteria:

* moderate to severe injuries(post-resuscitation scores GCS 4-12)
* age \>= 16 year
* non-penetrating TBI in 8 hours onset
* first CT brain in 8 hours onset
* non neurosurgical OR in 8 hours onset

Exclusion Criteria:

* patients with coagulopathy
* serum creatinine over than 2 mg%
* with associated major organ injury requiring surgery within 8 hours of injury
* pregnancy
* receiving any medication which affects haemostasis
Evaluation and Optimization of PB127 Myocardial Perfusion Echocardiography on Ultrasound Systems

The purpose of this clinical trial is to evaluate various commercially available ultrasound systems and to identify imaging parameters to be used with these systems (along with the contrast agent PB127) as well as to further evaluate the safety of PB127.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women

1. Normal volunteers (18 30 years old), with no history of CAD
2. Patients (≥ 18 years old) with known or suspected CAD, scheduled for or undergone clinically indicated coronary angiography within 28 days prior to or following Study Day 1

Exclusion Criteria:

1. Unable to provide written informed consent
2. Women who are pregnant or lactating
3. Known hypersensitivity or known contraindication to:

   1. Dipyridamole
   2. Ultrasound contrast agents (including PB127 and excipients)
   3. Blood, blood products, albumin, egg whites, or protein
4. Use of caffeine or xanthine containing products within the 24 hours prior to PB127 administration on Study Day 1
5. Previous exposure to PB127
6. Inadequate echocardiographic windows
7. Heart transplant
8. Known right to left shunt, including atrial septal defect
9. History of CABG
10. Current uncontrolled ventricular tachycardia, atrial fibrillation, atrial tachycardia, or atrial flutter
11. Pacemaker or defibrillator
12. Unstable angina grade CCS Class IV severity with ongoing symptoms and/or ongoing infusion of IV nitroglycerin
13. Second degree or greater heart block
14. Hypertension (SPB \>200 and/or DBP \>110 mmHg on two consecutive readings within 1 hour prior to PB127 administration)
15. Hypotension (SPB \<90 mmHg on two consecutive readings within 1 hour prior to PB127 administration)
16. Severe aortic stenosis (\>100 mmHg peak transvalvar gradient or \<0.6 cm2 estimated valve area)
17. Pulmonary edema within the 7 days prior to Study Day 1
18. Resting oxygen saturation of less than 90%
19. Q wave MI within the 7 days prior to Study Day 1
20. PTCA within the 28 days prior to Study Day 1
21. Chronic obstructive pulmonary disease or bronchospastic airway disease which, in the opinion of the Investigator, is significant enough to contraindicate dipyridamole
22. Known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of \>50 mmHg
23. Liver disease, characterized by or including one or more of the following

    1. Elevated total bilirubin \>upper limit of normal
    2. Currently elevated hepatic enzymes \>3X upper limit of normal
24. Medical conditions or other circumstances that would significantly decrease the chances of obtaining reliable data or achieving the study objectives (i.e., drug dependence, psychiatric disorder, dementia, or associated illness); extenuating circumstances or medical conditions that make it unlikely that a patient can complete the clinical trial or follow up evaluations; or other reasons for expected poor compliance with the clinical investigator's instructions
Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors

The study is being conducted to determine the maximum tolerated dose, overall safety and tolerability profile, and pharmacokinetic profile of CP-751,871 and sunitinib when given in combination with advanced solid tumors.

The study was closed to enrollment on 14 Jan 2011 and terminated secondary to excessive screen failure rate and for business reasons associated with Pfizer's business decision to stop development of the figitumumab compound. Safety concerns did not contribute to the decision to terminate this clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced solid tumors relapsed or refractory to standard therapy or for whom no standard therapy exists.
* ECOG Performance Status of 0 or 1;
* Total IGF-1 level ≥100 ng/ml;
* ECOG Performance Status of 0 or 1
* Adequate bone marrow, renal, and hepatic function

Exclusion Criteria:

* Concurrent treatment with any antitumor agents with the exception of LHRH agnosits for prostate cancer patients
* Treatment with any other investigational therapy within 4 weeks prior to study treatment
* Major surgery within 4 weeks of study treatment
* Prior treatment that may increase the risk of cardiac complications
* Ongoing cardiac dysrhythmias of NCI CTCAE Grade 2 or greater
* Significant active cardiac disease, including hypertension that cannot be controlled by medications
* Greater than three (3) prior lines of cytotoxic therapy;
* Active infection
* Prior IGF-IR targeted therapy;
Physiologic Evaluation of Anomalous Right Coronary Artery Stenosis

The anomalous origin of right coronary artery (RCA) is a rare coronary anomaly. Recently, the detection of this anomaly has been more frequent as the use of cardiac multidetector computed tomography has become more popular. It can cause myocardial ischemia, syncope and sudden cardiac death. Surgical repair is generally recommended for symptomatic patients. However, there is controversy concerning the proper evaluation and treatment strategy for patients without documented myocardial ischemia.

The stenotic lesion of anomalous origin of RCA will be assessed by fractional flow reserve (FFR).


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed as anomalous origin of right coronary artery from left coronary cusp

Exclusion Criteria:

* poor compliance
* need for percutaneous coronary intervention to significant coronary lesion
* failure of FFR for anomalous origin of right coronary artery
Addressing Psychosocial Needs and HIV Risk in Indian MSM

This study will develop and pilot test a combined individual and group-level behavioral HIV prevention intervention for men who have sex with men (MSM) in Chennai, India, addressing HIV risk within the context of broader psychosocial issues, including self-acceptance, substance use and social support.

MSM in India are at increased risk for HIV in a stigmatizing environment that includes discrimination and violence. There is a need for evidence-based MSM HIV prevention interventions that address HIV risk in the context of these psychosocial issues. This study consists of formative qualitative work followed by the development and testing of a pilot behavioral HIV prevention intervention for MSM in Chennai, India. Study goals are to maximize intervention feasibility and acceptability, estimate an effect size for a power analysis, and prepare for a full-scale trial to follow.

PHASE 1-Intervention Development. This phase involved the collection of formative data through MSM focus groups and key informant interviews to develop a subsequent pilot behavioral intervention.

PHASE 2-Open Pilot. Following Phase 1, the team conducted an open-phase non-randomized pilot of the intervention. Enrollment involved a baseline assessment that included an interviewer-administered behavioral assessment and voluntary counseling and testing for HIV and the STIs, syphilis, gonorrhea and chlamydia. Eleven MSM in Chennai then completed 6 group sessions and 4 individual sessions over 3 months. A follow-up behavioral assessment was administered upon completion of all sessions, and 6 months after baseline participants were again administered the questionnaire and HIV/STI testing.

PHASE 3-Pilot Randomized Controlled Trial. The study is currently in Phase 3, and the data articulated in this registry is for Phase 3. We are now conducting a pilot randomized controlled trial (RCT) of the intervention among 6 "batches" of 8 MSM in each group (n=48). Comparison groups (n=48) will receive the same baseline assessment and voluntary HIV/STI counseling and testing as the intervention groups. Based on Phase 2 findings, the intervention groups will meet for 4 group sessions and 4 individual sessions. Those assigned to receive the comparison condition will not receive these sessions. Participants complete the assessments approximately 3 months after randomization, and again 3 months after that.

Eligibility Criteria:
Inclusion Criteria:

* Man who has had unprotected sex with another man in past 3 months
* Resident of Tamil Nadu state, India
* Identifies as Khothi or Double-decker

Exclusion Criteria:

* Does not identify as a man (i.e. Hijra/ Ali/Transgendered)
* Under age 18
* Unable to complete or understand informed consent procedures
Efficacy of Low Dose Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding

We prepare this study to compare the efficacy of intermittent intravenous PPI infusion (relatively low dose PPI therapy) than continous PPI infusion method. Our hypothesis is that intermittent (40mg as a bolus injection daily for 72 hours) PPI therapy is not inferior to conventional high dose therapy.

Background Current guidelines recommend an intravenous bolus dose of a proton pump inhibitor(PPI) followed by continuous PPI infusion after endoscopic therapy in patients with high-risk peptic ulcer bleeding. However, intermittent PPI have not been inferior to continuous PPI infusion regimens in recent studies.

Objective The aim of this study was to compare the effect of intermittent (40mg as a bolus injection daily for 72hours) versus continuous (40mg as a bolus injection followed by continuous infusion at 8mg/hr for 72hours) intravenous pantoprazole for prevention of bleeding after endoscopic therapy of peptic ulcer bleeding. Also, the same comparison was performed in high-risk patients (Rockall scores ≥6).

Methods This single center cross-sectional study was conducted from january 2010 through december 2013. Patients who presented with overt or suspected upper gastrointestinal bleeding based on hematemesis and/or melena were eligible. These eligible patients were required to have a peptic ulcer with bleeding on emergency endoscopy performed within 24 hours after hospitalization. Exclusion criteria were refusal of endoscopy, gastrointestinal malignancy, Mallory-Weiss syndrome, variceal bleeding, bleeding d/t endoscopic procedure, small bowel bleeding, serious medical disease, etc. Demographic and medical data were obtained from the patients' medical records. Current or past history of medical diagnosis and drug history were also recorded. Statistical analysis performed using SPSS 21.0 software.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older who had undergone gastroscopy for melena, hematochezia or hematemesis due to bleeding peptic ulcers were eligible. These eligible patients were required to have a peptic ulcer with bleeding on emergency endoscopy performed within 24 hours after hospitalization

Exclusion Criteria:

* refusal of endoscopy, gastrointestinal malignancy, Mallory-Weiss syndrome, variceal bleeding, bleeding d/t endoscopic procedure, small bowel bleeding, serious medical disease
Tumor Electric Fields Treatment System for Glioblastoma

This early phase I trial will investigate the safety and feasibility of applying the Tumor Electric Fields Treatment System to subjects with recurrent glioblastoma.

Subjects who have previously completed radiotherapy and at least two cycles of chemotherapy with imaging or pathological evidence of tumor recurrence will receive Tumor Electric Fields Treatment System. The main objective is to evaluate the safety of applying the Tumor Electric Fields Treatment System to subjects with recurrent GBM.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pathological diagnosis of glioblastoma at first surgery (WHO Grade IV, supratentorial location);
* Age between 18 and 65 years, male or female;
* Previously completed radiotherapy and at least two cycles of chemotherapy;
* With imaging or pathological evidence of tumor recurrence;
* Karnofsky performance score (KPS) score ≥ 70 before intervention;
* With a life expectancy more than 3 months;
* Adopted effective contraceptive measures at child-bearing age;
* Provided written informed consent.

Exclusion Criteria:

* Patients unwilling to use the equipment ≥ 18h per day;
* With poor compliance or live too far from the research center, who cannot keep regular follow-up or adjust the electrode position of the treatment equipment, and who refuse to receive follow-up to terminal survival;
* With poor healing of scalp wound, poor scalp condition, large skull defect or other cases where electrodes are not suitable for wearing;
* Within 3 months from radiotherapy;
* Within 4 weeks from the last cycle of chemotherapy;
* Within 4 weeks from surgery for recurrence;
* Participated in other clinical trials.
* Pregnant;
* Epilepsy symptoms not effectively controlled;
* Blood and biochemical indicators in the following range: A. Liver function impairment: AST or ALT \> 3 times the upper limit of normal; B. Total bilirubin\> upper limit of normal value; C. Renal impairment: serum creatinine\>1.7mg /dL (\>150 mol/L); D. Coagulopathy: PT or APTT \>1.5 times normal; E. Platelets counts \< 100x10\^9/L; F. Absolute neutrophils count \< 1x10\^9/L; G. Hemoglobin \< 100g/L;
* With severe infectious diseases, such as acute severe infection and HIV positive;
* Other conditions, such as an implanted cardiac pacemaker or deep brain stimulator, severe intracranial edema, increased intracranial pressure resulting in midline shift\>5mm, clinically significant papilledema, or reduced level of consciousness, allergy to conductive coupling agent, gel, and other serious life-threatening diseases.
* Other circumstances considered inappropriate to participate in the research by the investigator.