cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE)

The purpose of this study is to evaluate the safety and tolerability of TAK-079 in comparison with matching placebo, administered once every 3 weeks over a 12-week dosing period in participants with active SLE who are receiving stable background therapy for SLE.

TAK-079 is being tested in a study population with moderate to severe SLE. This study will evaluate the safety and biologic activity of TAK-079 or matching placebo in combination with stable SLE background therapy.

The study will enroll approximately 24 participants across 3 sequentially enrolling cohorts. Each cohort will enroll 8 participants, where 6 participants will be assigned to TAK-079 injection, and 2 participants will be assigned to Placebo. Participants will receive TAK-079 or matching placebo in combination with principal investigator directed background therapy for SLE.

This multi-center trial will be conducted in the United States. Participants will make multiple visits to the clinic, and will be followed up for the safety assessment for the additional 12 weeks up to Week 24 after receiving their last dose of study drug. Based on the clinical assessments, participants may complete or may advance to long-term safety follow up period for an additional 12-week safety monitoring period up to Week 36.

Eligibility Criteria:
Inclusion Criteria:

1. The participant been diagnosed with SLE as defined by either the 2012 Systemic Lupus International Collaborating Clinics or the American College of Rheumatology diagnostic criteria.
2. The participant has a systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score greater than or equal to (\>=) 6.
3. The participant is positive for anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies and/or anti-extractable nuclear antigens (ENA) antibodies.

Exclusion Criteria:

1. The participant had an opportunistic infection less than or equal to (\<=)12 weeks before initial study dosing or is currently undergoing treatment for a chronic opportunistic infection, such as tuberculosis (TB), pneumocystis pneumonia, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria.
2. The participant currently has, or recently had, an acute or chronic infection requiring one or more of the following interventions: Hospitalization \<=30 days before the screening visit. - Administered parenteral (IV or intramuscular) antibacterial, antiviral, antifungal, or antiparasitic agents \<=30 days before the screening visit.
3. The participant has drug-induced SLE or any other rheumatologic or autoimmune disease (excluding secondary Sjögren syndrome or mixed connective tissue disease).
Miniaturized Extracorporeal Circulation Study

Rationale:

Contemporary coronary artery bypass grafting (CABG) continues to be associated with a significant risk of postoperative bleeding. Utilization of miniaturized extracorporeal circulation (miECC) significantly reduces the risk of postoperative bleeding but the underlying mechanisms are poorly understood.

Primary Objective:

To assess the impact of miECC compared to conventional extracorporeal circulation (cECC) on thrombin generation as indicator of the overall haemostatic capacity after CABG.

Secondary Objectives To evaluate the impact of miECC versus cECC on blood loss and transfusion requirement, coagulation and fbrinolysis, inflammatory response, haemodilution and haemolysis, endorgan protection, seasibility and safety

Study design:

Single-center, double-blind, parallel-group randomized controlled trial

Study population:

60 Patients undergoing non-emergent primary isolated CABG with ECC randomized 1:1 to receive either miECC or cECC

Blood samples will be obtained at the following time points:

* T0; preoperative after induction of anaesthesia (after insertion of central venous line)
* T1; after weaning of the ECC prior to protaminization
* T2; 10 minutes after full protaminization
* T3; six hours after the end of the ECC
* T4; 1. postoperative day (16-20 hours following end of surgery)

Eligibility Criteria:
Inclusion Criteria:

* Non-emergent CABG with ECC
* Current use of low-dose acetylsalicylic acid
* Agreement of eligibility by the multidisciplinary heart team

Exclusion Criteria:

* Inability to give informed consent
* Emergent treatment required (\< 24 hours)
* Concomitant cardiac surgery
* Previous cardiac surgery
* Severely reduced kidney function (eGFR \< 30ml/min/1.73m2 or on dialysis)
* Severely reduced ejection fraction (EF \< 45%)
* Diagnosis of bleeding disorders
* Non-aspirin antiplatelet drugs stopped \< 5 days preoperatively (Clopidogrel, Prasugrel, Ticagrelor, Ticlopidine)
* Current use of systemic glucocorticoid therapy
* Current use of vitamin K antagonists or new oral non-vitamin K anticoagulants
* Platelet count \> 450 or \<100 x 109/l prior to surgery
* Pregnant women or women of child bearing potential without negative pregnancy test
* Active participant in any other intervention trial
The PreNAPS Study: FI, Nutrition, and Psychosocial Health Outcomes at Gulu Regional Referral Hospital

The Prenatal Nutrition and Psychosocial Health Outcomes (PreNAPS) study was a two year collaboration between Gulu, Makarere, Cornell, and Tufts Universities. The PreNAPs study's primary goals were: a) to determine the differential impacts of food insecurity on gestational weight gain and prenatal depression, and b) to elucidate the mechanisms underlying the relationship between food insecurity and weight gain and/depression among HIV infected and HIV uninfected pregnant women in Gulu, Northern Uganda.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Known HIV status
* Receiving antiretroviral therapy (if HIV-infected)
* Attending antenatal care at Gulu Regional Referral Hospital
* \>18 years of age

Exclusion Criteria:

* Pregnant women \<18 years of age
* Unknown HIV status
* Not receiving antiretroviral therapy (if HIV-infected)
* Not attending antenatal care at Gulu Regional Referral Hospital
An Open-Trial of Web-Prolonged Exposure (Web-PE) Among Active-Duty Military

It is urgent to make evidence-based treatments (EBTs) for military personnel readily accessible in order to meet the growing demand for effective and efficient treatment for posttraumatic stress disorder (PTSD) in a timely manner. Effective EBTs for PTSD are available, but barriers to accessing care can deter military personnel from receiving treatment. Web-treatments represent an innovative way to overcome these barriers. The efficacy of previously developed web-treatments for PTSD appear promising, however, they are not based on treatment protocols with strong empirical support for their efficacy. No study to date has examined web-treatment of PTSD using a well-established treatment program.

The purpose of this open trial is to examine the efficacy of 10 sessions of a web-version of Prolonged Exposure (PE), "Web-PE," delivered over 8-weeks in 40 active-duty military personnel and veterans with PTSD who deployed post 9-11. Up to 60 individuals will be consented to obtain data from 40 for analysis. Participants will be assessed at pre-treatment and 1- and 3-months after treatment completion.


Eligibility Criteria:
Inclusion Criteria:

* Active-duty military personnel and veterans who have deployed post 9/11
* Seeking treatment for PTSD
* Significant PTSD symptoms as determined by a PCL-5 score greater than or equal to 31
* Has experienced a Criterion A event that is a specific combat-related event or high magnitude operational experience that occurred during a period of recent military deployment
* Able to speak and read English and access to an internet-connected computer
* Indication that the participant plans to be able to participant in the study for the next three months following the first assessment

Exclusion Criteria:

* Diagnosis of bipolar disorder or psychotic disorder, as determined by participant self-report)
* Current substance dependence, as determined by participant self-report)
* Diagnosis of a moderate or severe traumatic brain injury, as determined by participant self-report)
* Current suicidal ideation severe enough to warrant immediate attention, as determined by participant self-report)
* Currently engaged in evidence-based treatment for PTSD (e.g. Prolonged Exposure Therapy or Cognitive Processing Therapy), as determined by participant self-report.
Radiofrequency Ablation With Gradual Radiofrequency Energy Increment for Hepatocellular Carcinoma Treatment

To evaluate local tumor progression rate at 12 months after percutaneous radiofrequency ablation with gradual radiofrequency energy delivery mode with Octopus electrodes in patients with hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Child-Pugh Class A or B
* chronic hepatitis B or liver cirrhosis
* contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) within 60 days of scheduled radiofrequency ablation (RFA) date
* clinically diagnosed hepatocellular carcinoma (HCC), equal or less than 4 cm

Exclusion Criteria:

* number of HCC, equal or more than 3
* largest tumor size over 4 cm
* Child-Pugh class C
* presence of vascular invasion by HCC
* platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50%
* presence of extrahepatic metastasis
Pattern Recognition Prosthetic Control

This study investigates whether simultaneous electromyographic (EMG)-based pattern recognition control of an upper limb prostheses increases wear time among users. In contrast to conventional, seamless sequential pattern recognition style of control which only allows a single prosthetic hand or arm function at a time, simultaneous control allows for more than one at the same time. Participants will wear their prosthesis as they would normally at home using each control style for an 8-week period with an intermittent 1-week washout period (17 weeks total). Prosthetic usage will be monitored; including, how often participants wear their device and how many times they move each degree of freedom independently or simultaneously. The primary hypothesis is that prosthetic users will prefer simultaneous control over conventional control which will result in wearing their device more often. The secondary hypothesis is that simultaneous control will result in more efficient prosthesis control which will make it easier for participants to perform activities of daily living. The results of this study will help identify important factors related to prosthetic users' preferences while freely wearing their device within their own daily-life environment.


Eligibility Criteria:
Inclusion Criteria:

* Subjects have an upper-limb difference (congenital or acquired) at the transradial (between the wrist and elbow), elbow disarticulation (at the elbow), transhumeral (between the elbow and shoulder), or shoulder disarticulation (at the shoulder) level.
* Subjects are suitable to be, or already are, a Coapt pattern recognition user (Coapt Complete Control Gen2 device).
* Subjects are between the ages of 18 and 70.

Exclusion Criteria:

* Subjects with significant cognitive deficits or visual impairment that would preclude them from giving informed consent or following instructions during the experiments, or the ability to obtain relevant user feedback discussion.
* Subjects who are non-English speaking.
* Subjects who are pregnant.
Tirofiban for the Prevention of Neurological Deterioration in Acute Ischemic Stroke

Currently, dual antiplatelet therapy with aspirin and clopidogrel (with loading doses) is widely used for patients with acute ischemic stroke. However, immediate, potent and reversible inhibition of platelet aggregation is not possible. Additionally, more than 5% patients have aspirin resistance and more than 15% patients have clopidogrel resistance. Therefore, an intravenously administered GPIIb/IIIa receptor inhibitor (Tirofiban) receptor blocker with fast onset and offset of actions will provide more desired antiplatelet effects in the setting of acute ischemic stroke, especially in patients with high risk of neurological deterioration. This study will measure the anti-platelet effects of Tirofiban in patients with acute ischemic stroke who had high risk of neurological deterioration.


Eligibility Criteria:
Inclusion Criteria:

1. Acute ischemic stroke with 24 hours of symptom onset.
2. NIHSS≥4 and ≤20 points, and the paralyzed limbs is able to actively move the muscle (standardized motor examination rating scale of 2 or much higher).
3. Age 18-80 years old.
4. Informed consent obtained from patient or acceptable patient's surrogate.

Exclusion Criteria:

1. Treated with intravenous or endovascular thrombectomy for the indexed acute ischemic stroke.
2. Acute ischemic stroke caused by determined or suspected cardioembolism.
3. Acute ischemic stroke caused by other determined caused, including moyamoya disease, artery dissection, arteritis, and etc.
4. Pre-stroke mRS ≥2 or the paralyzed limbs are dyskinesia before stroke.
5. Known hematochezia, gastrointestinal bleeding and any other bleeding.
6. Allergy to tirofiban or its solvents.
7. Patients suffered from severe diseases, including malignant tumor, liver cirrhosis, kidney failure, congestive heart failure, and etc.
8. Gastrointestinal or genitourinary tract bleeding within 1 years.
9. Determined coagulation disorders, platelet dysfunction, or platelet count \<100\*109/L.
10. Major surgical operation or severe trauma within 1 month.
11. Hemorrhagic retinopathy.
12. Chronic hemodialysis.
13. Uncontrolled hypertension with systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg.
14. Acute pericarditis.
15. Other conditions that determined by the investigators.
CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a)

This open-label, randomized, 3-arm study will evaluate the efficacy and safety of obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m\^2 cycle 1, 500 mg/m\^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is \>6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.

Protocol BO21004 is divided into 3 separate Unique Protocol IDs for reporting results on clinicaltrials.gov because there are 3 separate primary analyses conducted at different time-points.

* BO21004 (Stage 1a) \[NCT01010061\] includes the analysis of 2 of the 3 arms obinutuzumab plus chlorambucil (Glb) compared to chlorambucil (Clb) reported here.
* BO21004 (Stage 1b) \[NCT01998880\] includes the analysis of 2 of the 3 arms rituximab plus chlorambucil (RClb) compared to chlorambucil (Clb) reported separately.
* BO21004 (Stage 2) \[NCT02053610\] includes the analysis of 2 of the 3 arms obinutuzumab plus chlorambucil (Glb) compared to rituximab plus chlorambucil (RClb) reported separately.

Eligibility Criteria:
Inclusion Criteria:

* Adults \>/=18 years
* Documented Cluster of Differentiation Antigen 20 (CD20) + B-Cell Chronic Lymphocytic Lymphoma (B-CLL)
* Previously untreated Chronic Lymphocytic Leukemia (CLL) requiring treatment according to the National Cancer Institute (NCI) criteria
* Total Cumulative Illness Rating Scale (CIRS) \> 6 and/or creatinine clearance \< 70 ml/min

Exclusion Criteria:

* Prior CLL therapy
* Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
* History of other malignancy unless the malignancy has been in remission without treatment for \>/=2 years prior to enrolment, and except for carcinoma in situ of the cervix, basal or squamous cell skin cancer, surgically treated low-grade prostate cancer, or ductal carcinoma in situ (DCIS) of the breast treated with lymphectomy alone
* Positive hepatitis serology (HBV, HCV) or positive HIV or Human T Cell Leukemia Virus (HTLV) testing
* Patients with active infection requiring systemic treatment
Long Term Study Of Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is Insufficient

To investigate the safety and efficacy of the long-term use of amlodipine 10 mg in subjects who will be able to enter a long-term study after completing the parent study "A double-blind comparative study between amlodipine 5 mg and 10 mg in patients with essential hypertension for whom amlodipine 5 mg is insufficiently effective" (Protocol No.: A0531085).

NCT00415623 (protocol A0531085)

Eligibility Criteria:
Inclusion Criteria:

* Patients who had completed the preceding study A0531085, Phase III study, who the investigator judged to be able to further treatment of long term administration in terms of efficacy and safety
* Patients who had a treatment compliance rate of at least 80%

Exclusion Criteria:

* The patient who met the discontinuation criteria in the preceding study A0531085
New Truncal Nerve Blocks for Thoracoscopic Surgery and Open Heart Surgery.

This study is divided to two sub-studies. First sub-study evaluates if Serratus Anterior Plane block (SAPB) reduces opioid consumption after thoracoscopic surgery. Secondly continuous SAPB is compared to continuous intercostal blockade. Second sub-study evaluates if Subpectoral Interfascial Plane block (SIP) reduces opioid consumption after medial sternotomy.

Serratus anterior plane block (SAPB) - sub-study

In this sub-study 120 patients will be randomly assigned to one of four groups:

SAPB group A 30ml of Ropivacaine 7,5mg/ml is injected above m. serratus anterior after thoracoscopic lung surgery. Injection is done under ultrasound guidance.

SAPB group B 30ml of Sodiumchloride 0.9 is injected above m. serratus anterior after thoracoscopic lung surgery. Injection is done under ultrasound guidance.

SAPB group C 30ml of Ropivacaine 7,5mg/m is injected above m. serratus anterior after thoracoscopic lung surgery. Also a multi-holed catheter is left in place. Through catheter 20ml Ropivacaine 2mg/ml is injected every 12 hours after surgery.

SAPB group D A multi-holed catheter is placed in single intercostal space under thoracoscopic visualization. 20ml of Ropivacaine 7,5mg/ml is injected after application of the catheter, also a continuous infusion of ropivacaine 2mg/ml is started. Rate of the infusion is determined by patients weight.

Subpectoral Interfascial Plane block (SIP) - sub-study

In this sub-study 80 patients will be randomly assigned to one of two groups:

SIP group A 20ml of ropivacaine 7,5mg/ml is injected under both pectoralis major muscles before medial sternotomy. Injection is done under ultrasound guidance.

SIP group B 20ml of sodiumchloride 0.9 is injected under both pectoralis major muscles before medial sternotomy. Injection is done under ultrasound guidance.

Every patients postoperative pain is treated with intravenous oxycodone PCA-pump.

The investigators will evaluate post operative pain based on the Numeric rating Scale, 24 hours oxycodone consumption. The investigators will also evaluate post operative chronic pain using three questionnaires: EQ5D, STAIT-TRAIT and Pain Detect. In SAPB sub-study the questionnaires are done three weeks and 6 months post. operatively. In SIP sub-study the questionnaires are done 6 months and 12 months post.operatively.

Eligibility Criteria:
Inclusion Criteria:

* Elective thoracoscopic lung surgery or elective open heart valve surgery

Exclusion Criteria:

* DM1 with complications, lack of co-operation, refusal, chronic pain, chronic intake of opioids or use of SNRI or tricyclic antidepressants.
Assessment of Facial Measurements, the Length of Mouth Corner-mandible Angle and Incisors-mandible Angle, for Determining the Proper Sizes of Oropharyngeal Airway

The purpose of this study is to assess the facial measurements for determining the proper sizes of oropharyngeal airway. Investigators hypothesized that the length between incisors and mandible angle is more appropriate to estimate the size of oropharyngeal airway compared with the length between mouth corner and mandible angle.


Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing surgery that requires general anesthesia

Exclusion Criteria:

* anticipated difficult intubation
* patients without teeth or with loose teeth
* cervical spine disease
* upper airway disease
* body mass index over 35 kg/m2
* pregnancy
The Efficacy of Methylprednisolone in the Treatment of Patients With Ocular Involvement in Behcet's Disease

The goal of this study is to examine the efficacy of 1gram/day intravenous pulses of methylprednisolone on 3 consecutive days in Behcet's patients with ocular involvement. A total of 34 Behcet's patients referring to Behcet's clinic in Shariati hospital whose problem was confirmed with new international criteria of Behcet's disease (ICBD) will be randomly assigned into one of the two equal groups of intervention or control. Behcet's patients are those with ocular involvement who were under the same cytotoxic treatment with cyclophosphamide and azathioprine. For the patients in the intervention group, intravenous infusion of 1000 mg methylprednisolone in 100cc D/w 5% or 100cc D/w5% on 3 consecutive days will be added to treatment diet. Then treatment will begin with oral prednisolone, 0.5 mg/kg. After that, all the patients were followed up with no other therapeutic intervention by study group. The patients will be visited every 2 months by an ophthalmologist and study group for 6 months in 3 settings. To estimate the ocular inflammation of patients, we use visual acuity, retinal and ocular posterior chamber inflammation index.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed Behcet's disease according to international criteria
* New or relapse of retinal vasculitis who received any cytotoxic or glucocorticoid since 2 months ago
* New or relapse of severe posterior uveitis who are candidate for cyclophosphamide and azathioprine according to their physician

Exclusion Criteria:

* Not Signing the informed consent
* Visual acuity lower than 1/10 by Snellen chart
* Presence of infectious diseases such as TB
* Presence of diabetes mellitus, hypertension, heart disease, liver disease, renal disease, or edema
* Presence of other glucocorticoid consumption contraindications
Electroencephalography in the Management of Neuroelectric Stimulation in Patients With Severe Traumatic Brain Injuries

The goal of this observational retrospective study is to evaluate the electroencephalography (EEG)'s poficiency in the treatment of neuroelectric stimulation in patients with severe traumatic brain injuries (TBI).

The main questions it aims to answer are:

1. Whether EEG of patients with severe TBI will change after they receiving neuroelectrial stimulation? If yes, how does it change?
2. How can EEG be used to evaluate the condition of patients with severe TBI?


Eligibility Criteria:
Inclusion Criteria:

* 7 days after severe traumatic brain injuries (GCS score 3-8);
* Over 18 years old, regardless of gender;
* The patient's legal representative is informed and voluntarily signs the consent form.

Exclusion Criteria:

* Unstable vital signs;
* History of mental disorders or neurodegenerative diseases;
* Uncontrolled epilepsy;
* Severe arrhythmias or patients with implanted cardiac pacemakers;
* Various conditions that interfere with scalp EEG collection;
* Pregnant women.