cyrilzakka/clinical-trials huggingface dataset:
Non-standardized Vs. Standardized Screening for Dysphagia

The purpose of this study is to compare two different screening tests for detecting dysphagia (difficulty swallowing) as well as the risk for aspiration (silent swallowing of liquids/solids into the lungs) in patients after an ischemic stroke (when a blood clot blocks or narrows an artery leading to the brain).


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years old
* Patients admitted to Lynn Rehabilitation Center with an admitting diagnosis consistent with acute ischemic stroke within the past 1 month
* Patients able to provide informed, written consent. If patients are not cognitively able to give informed consent, then consent will be obtained from patient proxy in person or over the phone
* Able to read and comprehend verbal instruction in English and/or Spanish

Exclusion Criteria:

* Adults \> 80 years old
* Pregnant women
* Prisoners
* Those with a prior history of dysphagia
* Those with any diagnoses that include acute intracranial hemorrhage, subdural hematoma, subarachnoid hemorrhage, traumatic brain injury
Intraosseous Access During Pediatric Resuscitation

The purpose of this study was to compare the Jamshidi, the BIG, the Cook, the EZIO intraosseous devices to standard peripheral venous catheterization during pediatric resuscitation.


Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* minimum 1 year of work experience in emergency medicine
* experienced emergency medical personnel - EMS-paramedics

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
Pharmacokinetic and Mass Balance Study of Orally Administered [14C]-AZD4205 in Healthy Adult Male Volunteers

This is a phase I, open label, healthy volunteers, ADME study with single oral administration of \[14C\]-AZD4205.

Phase I study to evaluate the excretion of AZD4205 radioactive dose, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of \[14C\]-AZD4205 in healthy male volunteers. The purpose of this study is to investigate ADME properties of AZD4205 by analyzing blood, urine and feces collected during the study

Eligibility Criteria:
Inclusion Criteria:

* 1. Healthy male subjects aged 18 to 65, who must be willing to use reliable methods of contraception, even if their partners are postmenopausal, surgically sterile, or using an effective hormonal method of contraception or intrauterine coil.
* 2. In addition, subjects must agree to continue to take similar contraceptive precautions until 6 months after administration of AZD4205 and avoid procreative sex as well as sperm donation for 6 months after administration of AZD4205.

Exclusion Criteria:

* 1. Any clinically relevant abnormalities in physical examination, vital signs, hematology, clinical chemistry, urinalysis or ECG at screening or baseline in the opinion of the investigator.
* 2. Subjects who may have been exposed to radiation for therapeutic or diagnostic reasons at levels above background (e.g,, through X-ray examination other than dental X-rays or plain X-rays of thorax or bony skeleton) of \> 5 mSv in last year, \> 10 mSv over last 5 years or a cumulative total of \> 1 mSv per year of life.
Performance of PLR as Predicting Preload Responsiveness

We aimed to establish current practice of correct application and interpretation of the PLR in critical care patients.

The points of concern for PLR include the following: the indication and contraindication of PLR; the choice of initial position: starting from a semi-recumbent position or supine position for PLR; how to interpret and apply the changes of CO, blood pressure, and central venous pressure (CVP) to identify fluid response during PLR; and how to identify spontaneous variation and sympathetic stimulation during PLR.

Eligibility Criteria:
Inclusion Criteria:

* All Critical care physicians of different medical disciplines

Exclusion Criteria:

* not completely responses
SelfWrap-Assisted Arteriovenous Fistulas

This is a single-center, prospective, single-arm clinical study to evaluate the feasibility, safety, and performance of VenoStent's SelfWrap® Bioabsorbable Perivascular Wrap on arteriovenous fistulas (AVFs). All participants are chronic kidney disease (CKD) patients already receiving hemodialysis treatments that are referred for creation of a new arteriovenous fistula (AVF).


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years, male or female;
2. Subjects already receiving hemodialysis treatments that are ultimately referred for a new AVF, per current US KDOQI Clinical Practice Guidelines for Vascular Access updated in 2019 which recommend an AVF or arteriovenous graft (AVG) consistent with patient life-plan, overall goals of care, and anticipated duration of hemodialysis; if life expectancy \> 1 year, recommend forearm AVF, forearm AVG, or upper arm AVF; if \< 1 year, recommend forearm AVG/upper arm AVG; if urgent start, early cannulation AVG or central venous catheter (CVC);
3. Target cephalic vein inner diameter ≥ 2.5 mm and target artery ≥ 2.0 mm as measured via duplex ultrasound with a tourniquet applied;
4. For radial AVFs, a nonpathological modified Allen test;
5. Triphasic arterial flow and intact venous outflow;
6. A vascular access site being used for hemodialysis that is either positioned contralateral to the planned AVF creation surgery or located in the groin. If the catheter is positioned on the same side as the planned AVF, the catheter will be moved to the other arm prior to the AVF created surgery.
7. Participant is willing and able to comply with study requirements and sign an informed consent.

Exclusion Criteria:

1. Planned index procedure to revise or repair an existing fistula;
2. Twelve months or longer with a catheter, on the planned side of AVF creation; or if there has been any previously failed AVF and AVG on the planned side of AVF creation.
3. Significant (\> 50%) stenosis at the target vein on the side of surgery, as diagnosed by preoperative ultrasound;
4. Known central venous stenosis \> 50%;
5. Amputated limb;
6. Use of a peripherally-inserted central catheter (PICC) line;
7. Abnormal cardiac rhythm;
8. Known coagulation disorder;
9. Known or suspected active infection at the time of surgery;
10. Congestive heart failure NYHA class 4;
11. Prior steal on the side of surgery;
12. Enrolled in another investigational drug, device, or biological study and has not completed the primary endpoint(s), or was previously enrolled in this study;
13. Life expectancy less than 12 months;
14. Patient expecting to undergo kidney transplant surgery within 12 months of enrollment;
15. Patient has a comorbid condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol or confound data interpretation.
16. Unwillingness or inability to give consent and/or comply with the study follow up schedule.
Histological Analysis of Sacrococcygeal Pilonidal Sinus Specimens

Minimally invasive techniques have been widely used routinely and reliably in the treatment of pilonidal sinus. In some of these methods, the cavity of sinus remains in the patient; this condition caused us to question the necessity of pathological examination. Except for prolonged duration of disease, elderly age, macroscopic suspicion, and recurrence; We think that routine pathological examination of the pilonidal sinus is unnecessary.

Pilonidal sinus is a benign disease. In the histopathological examination of pilonidal sinus specimens, malignancy can be detected rarely. Minimally invasive techniques have been widely used routinely and reliably in the treatment of pilonidal sinus. In some of these methods, the cavity of sinus remains in the patient; this condition caused us to question the necessity of pathological examination. The investigators aimed to discuss the pathological findings of patients who were operated for pilonidal sinus in our clinic in light of the literature. The fact that the rate of malignancy in the literature does not show parallelism with minimally invasive procedures that pathology samples are not taken and whose applications are increasing supports this prediction. Except for prolonged duration of disease, elderly age, macroscopic suspicion, and recurrence; the investigators think that routine pathological examination of the pilonidal sinus is unnecessary.

Eligibility Criteria:
Inclusion Criteria:

* sacrococcygeal pilonidal sinus

Exclusion Criteria:

* non-sacrococcygeal pilonidal sinus
* minimally invasive treatment without histopathological examination
Aerobic Exercise Training in Pulmonary Arterial Hypertension

Decreased exercise capacity, peripheral muscle strength and quality of life and increased dyspnea and fatigue perception is prevalent in patients with pulmonary arterial hypertension. It was demonstrated exercise training has beneficial effects in patients with pulmonary arterial hypertension. However, no study investigated the effects of upper extremity aerobic exercise training, therefore effects of upper extremity aerobic exercise training on outcomes in patients with pulmonary arterial hypertension.

Patients were diagnosed with pulmonary arterial hypertension according to the Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of f the European Society of Cardiology (ESC) and European Respiratory Society (ERS). Primary outcome measurement was exercise capacity, secondary outcomes were respiratory and peripheral muscle strength, physical activity, quality of life, fatigue, dyspnea and depression.

Eligibility Criteria:
Inclusion Criteria:

* Clinically stable
* Under standard medication
* Group 1 pulmonary arterial hypertension patients
* Having no exacerbation or infection

Exclusion Criteria:

* Cognitive disorders
* Orthopedic and neurological problems
* Pneumonia or acute infection
* Stage 4 heart failure
* Having no comorbidity to avoid performing evaluation and training
Safety, Tolerability and Pharmacokinetics of AUT00206 in Patients With Schizophrenia, and Also Explores the Effects of AUT00206 on Relevant Central Biomarkers.

This study will investigate the safety, tolerability, PK and PD profile of AUT00206 after repeated doses in patients with stable but symptomatic schizophrenia, taking one or two established anti-psychotic drugs. The subjects will undergo brain imaging, tests of cognition and tests of auditory function and electrophysiological measures in addition to routine safety monitoring. Because of the pioneering and novel mechanism of action of this drug, a key objective is to characterize this range of biomarkers which will inform the future development of the drug.


Eligibility Criteria:
Key inclusion Criteria:

* Male patients with a diagnosis of schizophrenia no more than 5 calendar years (before screening);
* Positive and negative symptoms assessed by PANSS;
* Medically and psychiatrically stable;
* On a stable dose of antipsychotic drugs;
* Able to give fully informed written consent and likely to comply with the requirements of the trial.

Key exclusion Criteria:

* clinically relevant, as assessed by a physician, abnormal findings at the screening assessment;
* sensitivity to excipients of the trial medication;
* current use of contraindicated drugs;
* participation in another clinical trial of unlicensed medicines within the previous 30 days;
* loss of more than 400 mL blood, within the previous 3 months; history of drug or alcohol dependence in the last year;
* significant acute or chronic illness;
* significant medical history or concurrent medical condition that warrants exclusion;
* objection by subject's physician
EA Treatment with Different Waveform for Subacute BP:study Protocol for a Randomized Controlled Trial

Bell palsy (BP) is a relatively common clinical disease, which leads to functional and esthetic disturbances for patients and results in a lowered quality of life. Electroacupuncture received attention in the management of BP. The aim of this study is to evaluate the curative effect of different waveform of electroacupuncture on peripheral facial paralysis in subacute stage and to screen out the optimal waveform.

This parallel-group, multicenter randomized clinical trial (RCT) will be conducted at the outpatient clinic of three hospitals in China.A total of seventy-five eligible patients will be randomly divided into low frequency continuous wave(n=25) ,discontinuous wave(n=25) and dilatational wave (n=25) groups.All groups will receive traditional acupuncture treatment at selected acupoints (BL2,GB1,GB14,ST2,SI18,ST4,ST6,ST7,SJ17,EX-HN16,EX-HN5,LI4),additionally,receive different waveform of electroacupuncture treatment for 20 minutes three times per week for four weeks.Facial Nerve Grading System 2.0 (FNGS 2.0) will be used to assess the curative effect at baseline and at 4 weeks after treatment, as the primary outcome.Sunnybrook facialgrad-ingsystem(SFGS) and Facial Disability Index (FDI)Scale will be measured and analyzed at baseline and at 4 weeks after treatment, as secondary outcomes.In addition,amplitude ratio of the affected/healthy side will be another secondary outcome tested by ENoG at bsaeline.

Eligibility Criteria:
Inclusion Criteria:

1. Patients meet the clinical classification criteria for BP, diagnosed by specialist.
2. 1-3 weeks from onset.
3. Male or female patients aged 18-65 years.
4. FNGS2.0≥4
5. Clearly aware, able to complete normal communication, signed informed consent.

Exclusion Criteria:

1. Facial paralysis due to other causes, such as stroke, Guillain-Barre syndrome, multiple sclerosis, encephalitis, facial nerve tumors, skin tumors, parotid tumors, and facial nerve trauma;.
2. Patients with Hunter's syndrome.
3. Patients with bilateral facial nerve palsy.
4. Patients with hemifacial spasm as the the main clinical symptoms.
5. Patients with severe cardiovascular and cerebrovascular diseases, liver, kidney, hematopoietic system diseases, malignant tumors and systemic organ failure, pregnant or lactating patients.
6. Patients with a tendency to bleed easily, who are not suitable for electroacupuncture such as installing a pacemaker, or who cannot cooperate with treatment for other reasons.
7. Participants in other clinical trials within the last 3 months.
Phase 3 Extension Study of Dexpramipexole in ALS

The purpose of the study is to collect long-term safety data from subjects with Amyotrophic Lateral Sclerosis (ALS) exposed to dexpramipexole.

Amyotrophic Lateral Sclerosis (ALS) is a rapidly progressive, degenerative disease of motor neurons in the brain and spinal cord that leads to muscle atrophy and spasticity in limb and bulbar muscles resulting in weakness and loss of ambulation, oropharyngeal dysfunction, weight loss, and ultimately respiratory failure. The purpose of this study is to collect long-term safety data from subjects with Amyotrophic Lateral Sclerosis (ALS) exposed to dexpramipexole.

Eligibility Criteria:
Inclusion Criteria:

* Subject has the ability to understand the purpose and risks of the study and provide signed and dated informed consent (or have the consent confirmed by a witness if unable to write) and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
* Subject was enrolled in either CL211 (NCT00931944) or Study 223AS302 (NCTO1281189).
* Subject has completed their last visit in Study CL211 (NCT00931944) or Study 223AS302 (NCTO1281189).
* Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 1 month (females) or 3 months (males) after their last dose of study treatment.

Exclusion Criteria:

* Subject withdrew prematurely from Study CL211 (NCT00931944) or Study 223AS302 (NCTO1281189).
* Subject permanently discontinued study treatment in Study CL211 (NCT00931944) or Study 223AS302 (NCTO1281189) for any reason other than enrollment into this study.
* Subject from Study CL211 (NCT00931944) or Study 223AS302 (NCTO1281189) has a significant change in medical history (including laboratory tests or a clinically significant condition) that in the opinion of the Investigator would impair the subject's medical fitness for participation and preclude treatment.
* Female subject who is pregnant or breastfeeding.
* Subject is currently enrolled in any investigational drug study other than Study CL211 (NCT00931944) or Study 223AS302 (NCTO1281189).
* Subject is taking pramipexole, other dopamine agonists, any other agent with dopaminergic activity, or any other disallowed concomitant medication.
* Subject is unwilling or unable to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol. At a minimum, subjects who are not able to travel to the study site must be willing to agree to remote blood draws for clinical laboratory evaluations and telephone visits to report Adverse Events, concomitant medications, and Amyotrophic Lateral Sclerosis Functional Rating Scale (revised) (ALSFRS-R) scores.
Different Limb Lengths in Gastric Bypass Surgery

Obesity and type 2 diabetes mellitus (T2DM) are reaching epidemic proportions in the developed world. In morbidly obese patients only surgical treatment (bariatric operations) leads to a sustained weight loss and relief of co-morbidities in the majority of patients. One of the most frequently performed operations is the laparoscopic proximal Roux-en-Y gastric bypass (LRYGB). There is still lack of knowledge why some patients respond much better than others to an identically performed procedure. Therefore, a number of variations of this operation have been introduced over the past 50 years. Increasing the length of small bowel being bypassed has the potential to improve the effect of the operation but buries the risk of nutrient deficiencies. The metabolic effect of LRYGB occurs, in part, independently of weight loss. The mechanisms underlying metabolic improvement through metabolic surgery are not yet fully understood.


Eligibility Criteria:
Inclusion Criteria:

* informed consent as documented by signature
* patients with BMI of 35 kg/m2 or higher who comply with the regulatory rules for bariatric surgery in Switzerland

Exclusion Criteria:

* general contraindications to kind of surgery
* known or suspected non-compliance, drug or alcohol abuse
* inability to follow the procedures of the study, e.g. due to language problems, psychological disorders etc. of the participant
* participation in another study
* age \< 18 years or \> 65 years
* BMI \> 60 kg/m2
* height \< 145 cm
* CL length of \< 180 cm as measured intraoperatively
* ASA physical status classification \> III
* inflammatory bowel disease
Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma

The study included 246 RCC patients who were at high risk for recurrence after nephrectomy (T2G3-4 or T3-4 or N1). They were randomly divided to receive axitinib plus PD-1 + surgery or surgery alone at a ratio of 1:1, so as to determine the efficacy of the neoadjuvant combination of axitinib plus PD-1.

Given the good results of TKI plus PD-1 in our previous cases and its good effect on advanced RCC, we plan to eliminate tumor micrometastases and improve anti-tumor immunity with the neoadjuvant combination of axitinib plus PD-1, so as to improve patient outcomes. The study included 246 RCC patients who were at high risk for recurrence after nephrectomy (T2G3-4 or T3-4 or N1). They were randomly divided to receive axitinib plus PD-1 + surgery or surgery alone at a ratio of 1:1, so as to determine the efficacy of the neoadjuvant combination of axitinib plus PD-1 and provide evidence-based medical evidence for clinical perioperative treatment of these patients.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females between 18 years old and 80 years old;
2. Histopathologically confirmed clear cell carcinoma;
3. Staged as T2G3-4 or T3-T4 or N1

Exclusion Criteria:

1. With distant metastasis
2. Severe liver and renal dysfunction, combined with other serious diseases;
3. Serious cardiovascular disease, including any of the following: myocardial infarction or arteritis or venous thrombosis (such as pulmonary embolism) in the past 1 year;
4. Severe/unstable angina pectoris; uncontrolled hypertension;
5. Class III or IV heart failure by New York Heart Association (NYHA) Functional Classification;
6. Ventricular arrhythmia requiring drug treatment.
Evaluation of the Spectra Optia® Mononuclear Cell Collection Procedure

The purpose of this investigation is to establish that hematopoetic stem cells collected on a new centrifugal blood separator, CaridianBCT's Spectra Optia Apheresis System, are able to reconstitute the hematopoetic systems of patients treated with myeloablative therapy, equivalent to hematopoetic cells harvested on the predicate COBE® Spectra platform.

This is a multi-center (3-5) single-arm study that will compare the performance of the Spectra Optia Apheresis System's MNC protocol to that of the historical performance of the COBE Spectra MNC protocol. In order to demonstrate the substantial equivalence of the two devices, a non-inferiority design will be used. The study will enroll patients with multiple myeloma who are to be treated with myeloablative chemotherapy, followed by bone-marrow rescue with an autologous peripheral blood stem-cell transplant. Peripheral blood stem cells will be collected using the Spectra Optia MNC protocol and re-infused following myeloablative chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Histologic confirmation of Multiple Myeloma
* Patients intended to be treated with myeloablative therapy and autologous hematopoetic stem-cell transplant within one month of stem-cell collection
* Patients whose stem-cell mobilization regimen includes G-CSF (granulocyte-colony stimulating factor)
* Males or non-pregnant females, who are 18 years of age or older
* Karnofsky score of ≥70%

Exclusion Criteria:

* Patients with pre-mobilization platelet count \< 75,000/µL
* Patients who have received pelvic bone marrow irradiation as part of their conditioning therapy
* Patients who have had a previous hematopoetic stem-cell transplant
* Patients who have had a previous hematopoetic stem-cell collection failure
* Impaired cardiac function, as evidenced by left ventricular ejection fraction \<40%.
* Impaired hepatic function, as evidenced by alanine transaminase \>2.5 x normal
* Impaired pulmonary function as evidenced by diffusion capacity of the lung for carbon monoxide (adjusted for patient hematocrit, if indicated) or forced expiratory volume in 1 second \<50% of predicted
* Impaired renal function, as evidenced by a creatinine clearance \< 40 mL/min
* Impaired coagulation, as evidenced by a prothrombin time (PT) \> twice normal
* Pregnancy or lactation
* Seropositivity for Human Immunodeficiency Virus-1/2, Hepatitis B Virus, or Hepatitis C Virus
* Documented bacterial or fungal infection that requires intravenous antibiotics to be started or continued while undergoing apheresis collection on the Spectra Optia device
* Subjects enrolled in study protocols that could affect number of CD34+ cells (pluripoten hematopoetic stem stells) collected or kinetics of neutrophil recovery
* Altered mental status, as evidenced by the inability to provide effective informed consent