cyrilzakka/clinical-trials huggingface dataset:
Immunotherapy of Natural Killer(NK) Cells in Human T Lymphotropic Virus Type 1(HTLV-1) Associated Myelopathy(HAM)

HTLV-1 Associated Myelopathy is a chronic disease of the spinal cord, caused by a virus called human T lymphotropic virus type 1（HTLV-1）. Natural Killer cells provide rapid responses to viral-infected cells, acting at around 3 days after infection, and respond to tumor formation. In this trial, the investigators aim to study the therapeutic safety and the effect on HTLV-1 virus. This in turn will improve the knowledge and understanding of the disease and should lead to better therapy.

HAM is a chronic disease of the spinal cord, caused by a virus called HTLV-I. Natural Killer cells provide rapid responses to viral-infected cells, acting at around 3 days after infection, and respond to tumor formation. In this trial, the investigators aim to study the therapeutic safety and the effect on HTLV-1 virus. This in turn will improve the knowledge and understanding of the disease and should lead to better therapy.

In a single-center, one year open-label trial, 5 HAM patients will be treated with single intravenous injection of NK cells (0.9\~1\*10\^9). Then, the the clinical effect was evaluated by dynamic analysis of Osame's Motor Disability Score and other related physiological indices, such as HTLV-1 antibody titer in blood and cerebrospinal fluid.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of HTLV-1 associated myelopathy

Exclusion Criteria:

* HIV infection
* Hepatitis B \& C viral infections
* Pregnant
Dysphagia in Cardiac Surgical Patients_

The proposed study seeks to determine the incidence of dysphagia and vocal fold mobility impairment (VFMI) in individuals undergoing cardiovascular surgical procedures. It also seeks to determine the impact of postoperative swallowing impairment on health-related outcomes.

Swallowing impairment and VFMI are common, yet often overlooked, complications of cardiovascular surgical procedures. The true incidence of both dysphagia and VFMI in this patient population is unclear due to a lack of rigorous study using instrumental assessment techniques and validated outcomes in all patients undergoing cardiovascular surgery. The study is therefore aimed to determine the incidence of dysphagia and VFMI in this patient population and to characterize impairment profiles related to swallowing safety and efficiency. In addition, the study is also aimed to assess the relative impact of VFMI and dysphagia on health-related outcomes such as length of hospital stay, pneumonia, sepsis, reintubation, and discharge status. We will identify risk factors for postoperative dysphagia and VFMI in cardiovascular patients to build a practical electronic risk-stratification tool. We also aim to identify sensitive bedside clinical markers of dysphagia in postoperative cardiovascular patients to develop a bedside screening tool. All participants will undergo two research visits (one preoperatively and one postoperatively) where they will undergo an instrumental swallowing test and complete several patient report outcomes and clinical tests. If they are found to have dysphagia after surgery, they will be offered no-cost follow up swallow tests at months 1 and 6. Finally, health-related outcomes will be indexed in enrolled participants to determine the impact of dysphagia.

Eligibility Criteria:
Inclusion Criteria: 1) individuals over 18 years of age, 2) undergoing a cardiovascular procedure at the University of Florida Heart and Vascular Hospital, 3) confirmed negative COVID-19 test result, 4) no allergies to barium, 5) not pregnant (female participants), and 6) willing to participate in research exams.

Exclusion Criteria: 1) individuals under the age of 18, 2) patients with a confirmed positive COVID-19 test result, 3) participants with allergies to barium, 4) pregnant women, or 5) unwilling to participate in research exams.
Driving Pressure in Laparoscopic Surgery

The effect of driving pressure (DP)-guided positive end expiratory pressure (PEEP) on early postoperative pulmonary ventilation is to be determined for patients undergoing laparoscopic surgery. Patients are recruited to receive volume controlled ventilation with either a fixed PEEP (5cmH2O) or DP titrated PEEP. Early postoperative regional distribution of lung ventilation, expressed as center of ventilation (COV) is evaluated by electrical impedance tomography (EIT), a noninvasive, radiation free modality. Perioperative ventilatory parameters, arterial oxygenation index (PaO2/FiO2) , serum indicators and postoperative pulmonary complications are secondary outcome variables.

After screened for preoperative risk factors, 48 patients undergoing elective laparoscopic surgery and planned to be extubated in the operating room are randomly assigned to two groups: (1) PEEP = 5cmH2O; (2) driving pressure (DP)-guided PEEP. The ventilation protocol consists of volume-controlled mechanical ventilation (Datex Ohmeda S/5 Advance; General Electric Company Healthcare, Helsinki, Finland) at a tidal volume (VT) of 8 ml/kg predicted body weight (PBW), fresh gas of 2 litre /min, inspiratory to expiratory ratio of 1:2, and a respiratory rate adjusted to normocapnia (arterial carbon dioxide partial pressure between 35 and 45 mmHg). For group 2, trial for the lowest DP was started 10 min after pneumoperitoneum and position adjustment by increasing PEEP from 5 to 15 cm H2O incrementally. DP was calculated as "plateau pressure - PEEP". Each PEEP level was maintained for 10 respiratory cycles, with DP in the last cycle recorded. Then the PEEP level producing the lowest DP was identified and maintained intraoperatively. A plateau pressure of no more than 30 cmH2O is targeted in each group.

Early postoperative distribution of regional ventilation as COV (center of ventilation) is the primary endpoint evaluated by EIT (electrical impedance tomography), which was performed by a trained technician who is blinded to randomization. Arterial blood gas is tested, with inflammatory and oxidative mediators from venous sample. Postoperative pulmonary complications within 3 days are also recorded.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent has been obtained
* Elective laparoscopic surgery with Trendelenburg position
* Expected ventilation duration \> 2 hours
* Scheduled to be extubated in the operation

Exclusion Criteria:

* Mechanical ventilation of \> 1 hour within the last 2 weeks before surgery
* Body mass index ≥ 35 kg/m2
* Acute respiratory failure (pneumonia, acute lung injury or acute respiratory distress syndrome)
* Emergency surgery
* Severe cardiac disease
* Progressive neuromuscular illness
* Pregnancy
* Refusal to participate
* Contradicted to EIT scan
A Study of the Effect of Vemurafenib on the Pharmacokinetics of Phenprocoumon in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy

This open-label, multicenter, parallel study will evaluate the effect of multiple doses of vemurafenib on the pharmacokinetics of a single dose of phenprocoumon in patients with BRAFV600 mutation-positive metastatic malignancies. Patients will be randomized to receive either treatment A: a single oral dose of phenprocoumon 6 mg on Day 1 (Eligible patients will have the option to continue treatment with vemurafenib as part of an extension study (NCT01739764).), or treatment B: vemurafenib 960 mg orally twice daily on Days 1-29 plus a single oral dose of phenprocoumon 6 mg on Day 22 (with the option to receive vemurafenib in the extension study after completion of pharmacokinetic assessments).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18-70 years of age
* Patients with either unresectable Stage IIIc or IV BRAFV600 mutation-positive metastatic melanoma or other malignant BRAFV600 mutation-positive tumor type and who have no acceptable standard treatment options
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Full recovery from any major surgery or significant traumatic injury at least 14 days prior to the first dose of study treatment
* Adequate hematologic and end organ function
* Female patients of childbearing potential and male patients with female partners of childbearing potential must agree to use 2 effective methods of contraception as defined by protocol during the course of the study and for at least 6 months after completion of study treatment

Exclusion Criteria:

* Prior treatment with vemurafenib or other BRAF inhibitor within 42 days of Day 1
* Prior anti-cancer therapy within 28 days (6 weeks for nitrosureas or mitocyn C, or 14 days for hormonal therapy or kinase inhibitors) before the first dose of study treatment Day 1
* Palliative radiotherapy within 2 weeks prior to first dose of study treatment Day 1
* Experimental therapy within 4 weeks prior to first dose of study treatment Day 1
* History of clinically significant cardiac or pulmonary dysfunction, including current uncontrolled Grade \>/=2 hypertension or unstable angina
* Current Grade \>/=2 dyspnea or hypoxia or need for oxygen supplementation
* History of myocardial infarction within 6 months prior to first dose of study treatment
* Active central nervous system lesions (i.e. patients with radiographically unstable, symptomatic lesions)
* History of bleeding or coagulation disorders
* Allergy or hypersensitivity to vemurafenib or phenprocoumon formulations
* History of malabsorption or other condition that would interfere with the enteral absorption of study treatment
* History of clinically significant liver disease (including cirrhosis), current alcohol abuse, or active hepatitis B or hepatitis C virus infection
* Human immunodeficiency virus (HIV) infection requiring antiretroviral treatment, or AIDS-related illness
* Pregnant or lactating women
Neurorehabilitation Using a Virtual Reality-based Mirror Therapy

In the proposed study, the investigators assumed that mirror therapy combined with virtual reality technology will provide a better treatment effects than traditional mirror therapy for the patients with unilateral stroke. The aim of the study is to examine the difference in the treatment effects among the combination of task-oriented training with either virtual reality based mirror therapy, mirror therapy or traditional occupational therapy on the upper extremity function and brain activity of the stroke patients.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of stroke with unilateral side involved;
2. A score of Mini-mental state examination greater than 24 for proving higher mental function;
3. Time of onset \> 6 months before treatment begins, and
4. Premorbid right-handedness.

Exclusion Criteria:

1. Vision loss;
2. Major cognitive-perceptual deficit;
3. Other brain disease.
CP1150 Sound Processor Speech Perception Compared With the Next Generation of Signal Processing Technology

This clinical study aims to investigate speech performance in quiet with an OTE Sound Processor with modified firmware compared with the commercially available CP1150. The study also investigates CP1110 and CP1150 with Forward Focus.

This study will build on the evidence previously collected on OTE and BTE Sound Processors and will support the design goals for access to the same sound processing algorithms across future OTE and BTE variants, including evidence required on the automation of FF and future implant compatibility.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or older
2. Post lingually deafened
3. Implanted with the CI600 Series, CI500 Series or Freedom Series
4. At least 6 months experience with a cochlear implant.
5. At least 3 months experience with a CP910/920, CP950, CP1150, or CP1000 Sound Processor
6. MAP Total Stimulation Rate of 7.2kHz or greater
7. Able to score 30% or more with CI alone on a monosyllabic words in quiet test
8. Willingness to participate in and to comply with all requirements of the protocol
9. Fluent speaker in English as determined by the investigator
10. Willing and able to provide written informed consent

Exclusion Criteria:

1. Additional disabilities that would prevent participation in evaluations.
2. Implant location that would result in undesirable hearing performance or discomfort with an off-the-ear sound processor, as determined by the investigator.
3. Unable or unwilling to comply with the requirements of the clinical investigation, as determined by the Investigator.
4. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
5. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
6. Currently participating or participated in another interventional clinical study/trial in the past 30 days unless (if less than 30 days) the prior investigation was Cochlear sponsored and determined by the investigator to not impact clinical findings of this investigation.
7. Implanted with other active implantable medical devices (e.g. pacemaker, defibrillator).
Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease

The study described below is designed to assess the safety and device performance for the drug coated balloon (DCB) for the treatment of urethral stricture.


Eligibility Criteria:
Inclusion Criteria:

1. Male subjects ≥ 18 years' old
2. Visual confirmation of stricture via cystoscopy or urethrogram
3. Single lesion anterior urethral stricture less than or equal to 3 cm
4. Two (2) or more prior diagnosis and treatment of stricture treatments (including self-catheterization) including DVIU (direct visual internal urethrotomy), but no prior urethroplasty
5. Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent UTI's (urinary tract infections).
6. IPSS (International Prostate Symptom Score) score of 13 or higher
7. Lumen diameter \<12F by urethrogram
8. Able to complete validated questionnaire independently
9. Qmax \<12 ml/sec
10. Guidewire must be able to cross the lesion

Exclusion Criteria:

1. Strictures greater than 3.0 cm long.
2. Subjects that have more than 1 stricture.
3. Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
4. Subjects who have a suprapubic catheter
5. Previous urethroplasty within the anterior urethra
6. Stricture due to bacterial urethritis or untreated gonorrhea
7. Stricture dilated or incised within the last 3 months
8. History of over active bladder or stress incontinence
9. Previous radical prostatectomy
10. Previous pelvic radiation
11. Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the past 6 months.
12. Presence of a penile implant, artificial urinary sphincter, or stent(s) in the urethra or prostate
13. Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function
Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus

The objective of this study is to evaluate and compare efficacy of 3 dose levels of PF-04236921 to placebo in subjects with generalized lupus using a measure called the Systemic Lupus Erythematosus (SLE) Responder Index. The study will evaluate secondary and exploratory measures as well.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between ages of 18 and 75 years old at time of signing consent.
* Have a clinical diagnosis of SLE according to 1997 update on the revised 1982 American College of Rheumatology (ACR) criteria.
* Have a unequivocally positive anti-nuclear antibody (ANA) test result.
* Active disease at screening defined by both: SLEDAI-2K score greater than or equal to 6 and BILAG Level A disease in more than or equal to 1 organ system (except renal or central nervous system) or BILAG B disease in more than or equal to 2 organ systems if no level A disease in present.

Exclusion Criteria:

* Any prior history of treatment with PF-04236921, or anti-IL-6 agent;
* Have received any of the following within 364 days of day 1: a biologic investigational agent other than B cell targeted therapy; required 3 or more courses of systemic corticosteroids for concomitant conditions; history of previously untreated or current evidence of active or untreated latent infection with Tuberculosis (TB), evidence of prior untreated or currently active TB by chest radiography, residing with or frequent close contact with an individual with active TB.
Comparison of Educational Services and Outcomes for Patients Treated for Childhood Cancer

The purpose of the study is to evaluate some educational outcomes of children treated for childhood cancer.

The aim of this telephone survey was to test the efficacy of systemic educational program services in improving school outcomes as compared to hospitals who provide educational liaison services in an ad hoc manner.Data from this study will be used to help secure funding to surther investigate the broader use of educational liaison services.

Eligibility Criteria:
Inclusion Criteria:

* must have had childhood cancer or brain tumor and been diagnosed between 1994-2001 and at least 6 years of age at diagnosis.
* must have been treated at Golisano Children's Hospital or Children's Hospital of Pittsburgh

Exclusion Criteria:

* less than 6 years of age
Genomics of Sudden Cardiac Arrest

Sudden cardiac arrest (SCA) is a sudden, unexpected loss of heart function. It is a leading cause of death, and more than 400,000 people in the United States die each year as a result of SCA. This study will analyze genetic samples of people who have experienced SCA and people who have not experienced SCA to determine if there is a genetic basis for SCA.

SCA occurs when the heart suddenly and unexpectedly stops beating. When this happens, blood stops flowing to the brain and other vital organs. Ninety-five percent of people who experience SCA die from it, most within minutes. SCA is usually caused by abnormal heart rhythms, known as arrhythmias, which can be triggered by several factors, including coronary artery disease, physical stress, and structural changes in the heart. Certain genetic factors may also increase the likelihood of experiencing SCA. Study researchers will analyze genetic samples from people affected by SCA and people unaffected by SCA to identify and characterize genetic variations that are associated with an increased risk of SCA in European Americans and African Americans.

This study will examine previously collected blood samples from people who have experienced SCA and were participants in the Cardiac Arrest Blood Study (CABS) and the Cardiovascular Health Study (CHS). These participants will not attend any study visits or be contacted by study researchers. People who experience SCA in the first 4 years of this study will have blood drawn from paramedics at the time of SCA. If these participants survive, they will be asked whether study researchers can review their medical records. Study researchers will also examine previously collected blood samples from participants who have not experienced SCA and were participants in CABS, CHS, and the Heart and Vascular Health Study. These participants will not attend any study visits or be contacted by study researchers. Study researchers will also enroll a new control group of people who have not experienced SCA. These participants will attend one study visit for blood collection and a medical record review.

Eligibility Criteria:
Inclusion Criteria for People with SCA:

* Experienced incident SCA

Inclusion Criteria for People without SCA:

* Matched to people with SCA on age, gender, and ethnicity

Exclusion Criteria for People with SCA and without SCA:

* Members of a vulnerable population
Comparison of Perfusion Index, T Wave Amplitude, Systolic Blood Pressure and Heart Rate

The purpose of this study is to determine whether changes in perfusion index can be used for detecting intravascular injection of an epinephrine in anesthetized adults and to compare its reliability with criteria using changes in heart rate, systolic blood pressure or T-wave amplitude.

Intravenous injection of local anesthetics could result in life-threatening complications during general anesthesia. Physicians usually use local anesthetics containing epinephrine to detect intravascular injection. Existing methods including heart rate, systolic blood pressure and T-wave amplitude are unreliable to detect intravascular injection during anesthesia and a method using changes in perfusion index was recently suggested. This study was designed to determine whether perfusion index is a reliable method to detect intravascular injection of epinephrine containing local anesthetics and to compare its reliability with conventional criteria in sevoflurane anesthetized adults.

We will randomize patients to 2 groups: a saline group and an epinephrine group. Changes in perfusion index, systolic blood pressure, heart rate and T-wave amplitude will be measured during 5 minutes after injection of 3 mL of saline or 1% lidocaine containing epinephrine. we will determine sensitivity, specificity, positive predictive value and negative predictive value.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1 patients undergoing general anesthesia for elective surgery

Exclusion Criteria:

* emergent operation
* those who are taking anticoagulant medication, calcium channel blockers, or b-blockers
* laparoscopic operation
* history of smoking
The Evaluation of the Effectiveness and Safety of Nalbuphine Hydrochloride Injection for Analgesia in ICU Patients: A Multicenter, Randomized, Single-blinded, Parallel, Two-step Trial

The analgesic effect of nalbuphine hydrochloride injection will be evaluated in a multicenter, randomized, single-blind, parallel, positive-controlled approach in two steps: step 1, to explore the optimal dosage of nalbuphine hydrochloride injection with 2 experimental arms and 1 positive control and step 2, to evaluate the effectiveness and safety of nalbuphine hydrochloride injection in mechanically ventilated ICU patients at a dosage determined in step 1 with the same positive control.


Eligibility Criteria:
Inclusion Criteria:

1. ICU patients who are intubated are expected to require mechanical ventilation for more than 6h
2. patients or their guardians have a full understanding of the purpose and significance of this trial, and voluntarily participate in this clinical trial and sign an informed consent form

Exclusion Criteria:

1. Allergy or unsuitability to any composition of study drugs or propofol
2. Living expectancy of less than 48 hours
3. Neurological disorder and any other condition interfering with sedation assessment
4. Gastrointestinal obstruction
5. Asthmatic
6. Abdominal compartment syndrome
7. Serious hepatic dysfunction (CTP 10-15)
8. Acute kidney injury (KDIGO stage 2 or 3) or Chronic kidney disease with glomerular filtration rate (GFR) \< 29 ml/min/1.73m2
9. Circulatory instability (the need for a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain proper blood pressure)
10. Need deep sedation or paralytics
11. Anticipation to receive operations (including tracheotomy)
12. Abuse of controlled substances or alcohol
13. Pregnancy, lactation, or an intention of gestation in 6 months
14. Inclusion in another interventional trial in the past 30 days
15. Other conditions deemed unsuitable to be included