cyrilzakka/clinical-trials huggingface dataset:
The Longitudinal CONQUER Study of Rare Neuroimmunologic Disorders

This study seeks to determine the biologic causes of inflammation in patients with Transverse Myelitis (TM) Neuromyelitis Optica Spectrum Disorder (NMOSD) and related conditions. While patients will be treated according to decisions with their treating physician, this study will collect data and samples from patients prospectively to gain a better understanding of the disease. We are seeking to understand why some patients respond to medications, while others do not. We also seek to understand what happens biologically, preceding relapses. Gathering these data and samples will allow researchers to identify new ways of diagnosing and treating these diseases. Data and samples will be shared with researchers around the world to support collaborative efforts to treat these conditions.

This study seeks to determine the biologic causes of inflammation in patients with Neuromyelitis Optica (NMO), Transverse Myelitis (TM), optic neuritis (ON), related conditions and healthy controls. While patients will be treated according to decisions with their treating physician, this study will collect data and samples from patients prospectively to gain a better understanding of the disease. We are seeking to understand why some patients respond to medications, while others do not. We also seek to understand what happens biologically, preceding relapses. Gathering these data and samples will allow researchers to identify new ways of diagnosing and treating these diseases. Data and samples will be shared with researchers around the world to support collaborative efforts to treat these conditions.

Patients will agree to share medical records, complete questionnaires and donate samples on a timed basis.

Eligibility Criteria:
Inclusion Criteria:

* Age 6 years or greater
* Male or Female
* Patient or Parent (in the case of a minor) able to give informed consent
* For patients 10 to 17, patient able to assent
* Patient diagnosed with NMO, NMOSD, TM or ON

Exclusion Criteria:

* Unable to maintain scheduled visits
* Patient has known HIV or hepatitis C infection
North American Prodromal Synucleinopathy Consortium

This study will enroll participants with idiopathic rapid eye movement (REM) sleep behavior disorder (RBD), for the purpose of preparing for a clinical trial of neuroprotective treatments against synucleinopathies.

REM sleep behavior disorder (RBD) is a rare disorder where people act out their dreams. People with RBD often, but not always, develop Parkinson's Disease, dementia with Lewy bodies, multiple system atrophy, or other neurodegenerative diseases of the synucleinopathy type. The North American Prodromal Synucleinopathy (NAPS) Consortium was formed with the purpose of enrolling participants with RBD, in anticipation of a future clinical trial of a neuroprotective treatment against synucleinopathies. The NAPS Consortium will collect standardized clinical assessments, biofluids, and other data in order to develop biomarkers for synucleinopathies in the prodromal (presymptomatic) stage as well as a trial-ready registry of participants. Participants procedures will include a \~2-hour clinical assessment (medical history and physical exam), questionnaires, blood draw, and (at select sites) optional lumbar puncture.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic REM sleep behavior disorder

Exclusion Criteria:

* REM sleep behavior disorder secondary to another cause (ex: narcolepsy, dementia, Parkinson's Disease, etc)
* Other neurological disorder
Echocardiographic Changes During Adjuvant Therapy in Hispanic Women With Her-2 Neu Expressing Breast Cancer

This study retrospectively looks at changes in Echocardiographic parameters while using transtuzumab

Transtuzumab based chemo-immunotherapy is commonly administered to patients diagnosed with early stage HER-2 expressing breast cancer, because it decreases the risk of relapse.

Transtuzumab affects cardiac function and potential benefits in decreasing cancer recurrence have to be balanced against short and long term toxicity.

We have previously identified a high prevalence of metabolic syndrome and type II diabetes mellitus in our patients with breast cancer. These patients may be particularly susceptible to cardiotoxic effects of transtuzumab based therapy.

Aim of this study is to assess the changes in the cardiac function of women who are undergoing transtuzumab based therapy for early stage breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Stage 1,2,3 breast cancer
* Her2+

Exclusion Criteria:

* Stage 4 cancer
Promus - Registry Experience at the Washington Hospital Center, Drug-eluting Stent (DES)

Single-center registry of patients treated with at least one Promus, everolimus-eluting, Stent, with the primary objective to assess clinical success and safety at 30 days, 6 months and 1 year post-implantation.

Interventional cardiology was revolutionized by the invention of stents, initially with the bare-metal stents (BMS) and recently with the drug-eluting stents (DES). The everolimus eluting stents have shown very promising results in randomized clinical trials, demonstrating a reduction of clinical and angiographic restenosis in comparison to BMS, and comparable clinically-driven target lesion revascularization rates in comparison with sirolimus-eluting stents. While registry data is available from outside of the United States, it will be important to collect "real-world" data regarding the stent usage and outcomes in the United States. In this study we propose to follow patients who received at least one Promus® Stent for at least 1 year post initial stent implantation.

Eligibility Criteria:
Inclusion Criteria:

* Patients, male or female, \>18 years of age
* Patients who received at least one Promus drug-eluting stent at the Washington Hospital Center

Exclusion Criteria:

* N/A
TOCILIZUMAB IN FIBROUS DYSPLASIA OF BONE

Bone pain due to fibrous dysplasia of bone is usually treated with bisphosphonates. A small proportion of patients fail to respond adequately. Mutated bone cells produce large amounts of Interleukin-6 (IL-6), with increased bone resorption as a result. Inhibition of IL-6 may be of interest to reduce bone resorption and therefore bone pain. TOCIDYS is a placebo-controlled randomized cross-over trial to test the hypothesis that tocilizumab can reduce bone resorption in those patients with fibrous dysplasia who have already received bisphosphonates.


Eligibility Criteria:
Inclusion Criteria:

* fibrous dysplasia of bone
* previously treated with IV bisphosphonates
* persistent bone pain and increased bone remodeling

Exclusion Criteria:

* Chronic renal failure
* serious infectious diseases
* liver enzymes abnormality
* pregnancy
* dyslipidemia
A Study of GC33 (RO5137382) in Patients With Advanced or Metastatic Hepatocellular Carcinoma

This randomized, placebo-controlled, multicenter study will evaluate the efficacy and safety of GC33 (RO5137382) in previously treated patients with unresectable advanced or metastatic hepatocellular carcinoma. Participants will be stratified according to the level of GPC-3 expression in tumors and randomized to receive either GC33 (1600 mg intravenously) or placebo on Days 1 and 8 of Cycle 1 and every 2 weeks thereafter. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically confirmed hepatocellular carcinoma (without fibro-lamellar subtype)
* Prior treatment with at least 1 systemic agent, with documented progressive disease after systemic agent(s), or documented adverse event(s) associated with prior systemic agent(s) that resulted in discontinuance of that (those) agent(s)
* Not a candidate for curative treatments (e.g. resection, transplantation)
* Child-Pugh A (score of 5-6)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate hematologic, hepatic and renal function
* Ability to provide, for central review, a tumor tissue sample to determine the level of GPC-3 expression by IHC
* Measurable disease by RECIST criteria

Exclusion Criteria:

* Child Pugh B or C
* Known hepatocellular carcinoma with fibro-lamellar histology
* Known brain or leptomeningeal metastases
* Active infectious diseases requiring treatment except for hepatitis B and C
* History of organ allograft including liver transplant
* Anticipated or ongoing administration of anticancer therapies other than those administered in this study
* Anticancer treatment within 2 weeks prior to entering the study
* Patients who have not fully recovered from toxicities associated with previous HCC loco-regional or systemic therapies
* Patients receiving interferon therapy
* Pregnant or lactating women
* Known HIV positivity or AIDS-related illness
* History of significant hypersensitivity to similar agents (monoclonal antibody, protein-included drugs, Chinese hamster ovary products)
A Phase II Double Blind Comparative Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

The purpose of this study is to evaluate the efficacy and safety of KPS-0373 compared to placebo in patients with Spinocerebellar Degeneration (SCD).


Eligibility Criteria:
Inclusion Criteria:

* Japanese SCD patients with mild to moderate ataxia

Exclusion Criteria:

* Patients with secondary ataxia
* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Dexmedetomidine as an Adjuvant for Femoral Nerve Block and Functional Recovery After Total Knee Arthroplasty

Femoral nerve block (FNB) is a first-line analgesic technique for multimodal analgesia after total knee arthroplasty (TKA). Recent studies and meta-analysis indicate that dexmedetomidine combined with local anesthetics for FNB can prolong the analgesic duration, improve the analgesic efficacy, inhibit local inflammatory response, and reduce narcotic consumption. The investigators hypothesize that dexmedetomidine combined with ropivacaine for FNB can also improve functional recovery in aged patients after TKA.

Many patients following total knee arthroplasty (TKA) complain moderate to severe postoperative pain. Multimodal analgesia, a combination of different techniques and analgesic agents, plays an increasingly important role to relieve pain after TKA. Femoral nerve block (FNB) is a first-line analgesic technique for multimodal analgesia after TKA. But local anesthetics alone often exert limited potency of analgesia and are insufficient to avoid supplemental opioid usage. Dexmedetomidine, a selective alpha 2-adrenergic receptor agonist, is widely used in clinical settings due to its properties of sedation, anxiolysis, analgesia, and sleep promotion. Recent studies and meta-analysis indicate that dexmedetomidine combined with local anesthetics for FNB can prolong the analgesic duration, improve the analgesic efficacy, inhibit local inflammatory response, and reduce narcotic consumption. The investigators hypothesize that dexmedetomidine combined with ropivacaine for FNB can also improve the functional recovery in aged patients after TKA.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥65 years but \<90 years;
* Scheduled to undergo unilateral total knee arthroplasty;
* Planned to use femoral nerve block and patient-controlled intravenous analgesia (PCIA) for multimodal analgesia.

Exclusion Criteria:

* Scheduled for bilateral total knee arthroplasty or revision surgery;
* Contraindications to femoral nerve block;
* Preoperative history of schizophrenia, myasthenia gravis, inability to communicate because of coma, severe dementia, or language barriers;
* Preoperative history of hemorrhagic disease or coagulopathy;
* Preoperative obstructive sleep apnea (diagnosed sleep apnea syndrome or a STOP-Bang score ≥3 combined with a serum bicarbonate ≥28 mmol/L);
* Sick sinus syndrome, severe sinus bradycardia (\< 50 beats per minute), or second-degree or above atrioventricular block without pacemaker;
* Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (requirement of renal replacement therapy before surgery), or American Society of Anesthesiologists physical status \>III;
* Preexistent delirium (diagnosed by Three-Dimensional Confusion Assessment Method);
* Under treatment with dexmedetomidine or clonidine.
Effect of Airway Video Library on Intubation in Novices

Endotracheal intubation requires significant training and expertise. This experience can be quite stressful for novice users. To accelerate the learning curve of newly enrolled trainees to assess and secure airway, the investigators propose supplementing current training techniques with access to an airway video library consisting of real- life clinical videos of airway and endotracheal intubations.

Timely and correctly performed endotracheal intubation is important. It can be stressful especially among beginners and requires significant expertise. Studies suggest that endotracheal intubation success rates are below 50% for the first 10 intubations among novices and the learning curve of laryngoscopy does not plateau above a 90% success rate until a mean of 57 attempts. Although simulation, which is currently the mainstay of training for airway management help orient a novice user, it is siloed from the actual experience. Endotracheal intubation requires significant training and expertise. This experience can be quite stressful for novice users. To accelerate the learning curve of newly enrolled trainees to assess and secure airway, the investigators propose supplementing current training techniques with access to an airway video library consisting of real- life clinical videos of airway and endotracheal intubations.

Eligibility Criteria:
Inclusion Criteria:

* Incoming anesthesia resident (CA-1 year)

Exclusion Criteria:

* Participants with prior experience of more than 60 intubations
Stress Management for Couples Undergoing In Vitro Fertilization (IVF)

The investigators are trying to determine stress management strategies in couples undergoing In Vitro Fertilization (IVF).

The investigators are trying to determine two different stress management techniques in couples undergoing IVF. One arm will be randomized to learning these techniques by themselves by watching and following instructions on a digital video disc (DVD). The other arm will have an in-person class that will teach the couples different stress reduction techniques.

Eligibility Criteria:
Inclusion Criteria:

* Women with clinical infertility, either primary or secondary, who are recommended for IVF for the first time as part of their treatment for infertility
* Women with a partner, and both are willing to provide consent for study participation as a couple
* Couples that can be reached by telephone for follow-up

Exclusion Criteria:

* Women less than 18 years of age
* Women equal or greater than 40 years of age
* Women with a history of recurrent pregnancy loss
* History of current or recent psychotic episode within past 6 months for either the woman or her partner
* Couples needing a interpreter for their clinical encounter
SAL067 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

This is the first phase 3 randomized, double-blind, placebo/active-controlled clinical study to evaluate the efficacy and long-term safety of SAL067 in treatment-naive T2DM patients uncontrolled with diet and exercise intervention, comprising 24 weeks of double-blind treatment period followed by an open-label treatment period, making up a total of 52 weeks.

All eligible subjects would enter the 24 weeks of double-blind treatment period and were randomized into the SAL067 group (12 mg once daily) or alogliptin group (25 mg once daily) or placebo group at a 2:1:1 ratio. After 24 weeks of double-blind treatment, subjects would enter the extended open-label treatment period. Subjects in the placebo group were to be switched to SAL067 (12 mg once daily) treatment, while patients in the SAL067 and alogliptin groups continued the same treatment until the end of the whole 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes patients who meet the diagnostic criteria for diabetes issued by the World Health Organization (WHO) in 1999;
2. Men or women aged 18 to 75 years old at the day of signing the informed consent;
3. Body mass index: BMI 19kg/m2 to 35kg/m2, \[BMI=weight (kg)/height 2 (m2)\];
4. Glycated hemoglobin (HbA1c): Screening period: HbA1c 7.5% to 10.5% (tested by the research center), when randomly enrolled: HbA1c 7.0% to 10.0% (central laboratory test) Measurement);
5. Screening period and random time fasting blood glucose \<=13.9mmol/L;

Exclusion Criteria:

1. Drug compliance during the introduction period \<80% or \>120%;
2. Use other hypoglycemic drugs other than test drugs during the introduction period;
3. The patient may have any contraindications, allergies or hypersensitivity to fuglitagliptin (including study drug and placebo) or its excipients, DPP4 drugs, metformin;
4. Before screening, have any of the following endocrine-related medical history or evidence:

   * Diabetes other than type 2 diabetes, such as type 1 diabetes, single-gene mutation diabetes, diabetes caused by pancreatic injury or secondary diabetes, such as diabetes caused by Cushing's syndrome or acromegaly;
   * diabetic ketoacidosis, hyperglycemia and hyperosmolarity, lactic acidosis and other acute complications of diabetes within 6 months before screening;
   * severe hypoglycemia episodes (such as sleepiness caused by hypoglycemia, unconsciousness, nonsense, and even coma), or a serious history of unconscious hypoglycemia;
5. Before screening, there is a history or evidence of any of the following diseases:

   * Unstable angina, stroke or transient ischemic attack, myocardial infarction, coronary artery bypass graft or percutaneous coronary intervention (diagnostic angiography is allowed of);
   * Decompensated heart failure before screening (New York Heart Association NYHA heart function grades III and IV, persistent and clinically significant arrhythmia;
   * A history of acute and chronic pancreatitis, symptomatic gallbladder disease or history of pancreatic injury, etc. may lead to high risk factors for pancreatitis;
Unrestricted Rehabilitation Following Primary THA

The purpose of this study is to determine whether the form of rehabilitation following primary total hip arthroplasty has an influence on patient satisfaction or functional performance in the eighteen weeks following surgery.

The current standard of care following total hip replacement is to restrict patient activity and range-of-motion with the goal of avoiding dislocation of the operative hip. These restrictions are commonly referred to as "hip precautions". Several recent studies have demonstrated these precautions may be safely abandoned with no increased risk of dislocation when the surgery is carried through an anterior/lateral approach. Previous work has failed to address the issue of patient satisfaction and functional performance when patients are managed with an unrestricted rehabilitation protocol post-operatively. We propose a prospective, randomized clinical trial to determine whether an unrestricted postoperative rehabilitation protocol has an impact on patient satisfaction and functional performance following primary total hip arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 50 years
* Undergoing primary total hip arthroplasty at Holland Orthopaedic and Arthritic Centre

Exclusion Criteria:

* Any previous surgery about the ipsilateral hip
* Patients being considered for simultaneous bilateral total hip arthroplasty
* Patients with a neuromuscular disorder or recognized hypermobility syndrome
* Patients without sufficient language skills to communicate in spoken and written English
Image Quality and Radiation Dose in Angiography

ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose significantly. This is realized by anatomy-specific optimization of the full acquisition chain (grid switch, beam filtering, pulse width, spot size, detector and image processing engine) for every clinical task individually. Furthermore, smaller focal spot sizes and shorter pulses are used, which are known to positively influence image quality . The final effect on the clinical image quality is investigated in this study.

The advent of interventional neuroradiology (INR) has changed the treatment of neurovascular diseases by reducing the procedural invasiveness and the recovery time needed by patients, thus improving clinical outcome. However, INR procedures often require many high-quality digital substraction angiography (DSA) runs and long total fluoroscopy times, which can result in patients being exposed to considerable radiation doses levels.

In order to introduce a dose reduction technology the most important aspect is to validate the diagnostic image information. Philips has developed a real-time noise reduction algorithm for DSA in neuroradiology that is capable to reduce the patient entrance dose by 75% without loss of image quality.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* Normal kidney function
* Neurologically intact
* Planned for diagnostic angiography or endovascular treatment

Exclusion Criteria:

* Pregnancy
* Other conditions that limit the use of contrast media or ionizing radiation
The Effect of Curcumin Against Colistin-induced Nephrotoxicity

The goal of this study is to investigate the possible nephroprotective effect of curcumin in critically ill patients receiving colistin.

The study will investigate the possible nephroprotective effect of curcumin when added to patients infected by MDR Gram-negative bacteria and require intravenous colistin therapy, curcumin will be given concurrently with colistin and discontinued at the same time as Colistin.

Eligibility Criteria:
Inclusion Criteria:

* All critically ill adult patients (18-65 years old) who are infected by MDR Gram-negative bacteria and require intravenous colistin therapy

Exclusion Criteria:

* Patients receiving intravenous colistin therapy for \< 72 hours.
* Patients receiving renal replacement therapy (RRT).
* Patients with diseases that may contribute to renal impairment such as systemic lupus erythematosus, acute myocardial infarction, cancer, HIV infection, glucose-6-phosphate-dehydrogenase deficiency, or urinary tract stone.
* Pregnancy or breastfeeding.
* Known allergy to the study medications.
* Patients with chronic kidney diseases (creatinine clearance \< 60 mg/dL).
* Elevated total liver enzymes (AST, and ALT) three times above the upper limit of normal.
* Patients with acute decompensated heart failure signs and symptoms requiring intravenous loop diuretics and/or intravenous inotropes and/or ACE inhibitors.
* Uncontrolled diabetes (Glycosylated hemoglobin (Hb A1C) \>8%).
* Hypotensive patients defined as decrease in blood pressure less than 90/60 mm Hg.
* Recent use of vitamins with antioxidant properties such as beta carotene, vitamin E, vitamin C, selenium, or N-acetylcysteine or any other medications known to have nephroprotective activities.
* Patients receiving other nephrotoxic drugs at enrollment (e.g., aminoglycosides, vancomycin, or amphotericin B) or administration of contrast medium within 7 days.