cyrilzakka/clinical-trials huggingface dataset:
Comparison of Ambulatory and Functional Improvement by Morning Walk

The aim of this study is to determine the clinical efficacy and feasability of gait rehabilitation robot through approving functional improvement by an end-effector typed gait robot in patients underwent total knee arthroplasty.

pre-interventional evaluation; within 1 day of initiation of the intervention; 5 days after initiation of the intervention; 10 days after intervention after initiation of the intervention; 42 days after intervention start

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent Unilateral or both Total Knee Arthroplasty

Exclusion Criteria:

* brain disease, spinal cord injury, peripheral neuropathy, myopathy
* Inability to ambulate fully due to muscukoskeletal disorders
* MMSE\<23
* history of arthroplasty surgery on either of legs
* Cardiac pacemaker
* Refusal of participation
A Study to Determine the Safety and Tolerability of Escalating Doses of INS365 Ophthalmic Solution

The purpose of this study is to evaluate the safety and tolerability of INS365 Ophthalmic Solution when applied topically as eyedrops in patients with mild to moderate dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Best corrected visual acuity 20/40 in each eye
* 2 out 5 specified symptoms
* Corneal fluorescein staining score greater than or equal to 3 out of 15

Exclusion Criteria:

* Unable to stop concomitant medications
* Have had intraocular surgery in previous 90 days
* Have excluded systemic or ocular disease
* Wear contact lenses and are not willing to remove them
* Have intraocular pressure greater than 22 mg Hg
Inhaled Nitric Oxide (INO) In Hypoxic Respiratory Failure

This Phase 3, Double-blind, Randomized, Placebo controlled, multicenter study is to confirm the efficacy of inhaled nitric oxide for the management of hypoxic respiratory failure associated with pulmonary hypertension in preterm infants.

Study subjects will be administered either inhaled nitric oxide or placebo to determine if there is a change in oxygenation.

This trial will be a multi-center, double blind, placebo-controlled, randomized clinical trial. All mothers identified with prolonged rupture of membranes and/or oligohydramnios, and all inborn infants \< 30 weeks gestational age (GA) at birth will be screened for enrollment. Infants who meet all inclusion and exclusion criteria within the first 48 hours after birth will be randomized to either inhaled NO starting at 20 ppm, or matched placebo, delivered by means of a blinded INOvent® delivery device. Randomization will be stratified by center and treatment will be assigned using an interactive voice or web-based response system (IVRS). All infants will receive up to 14 days of therapy, following a dose reduction schedule. The primary outcome measure will be change in oxygenation at 1 hour after start of therapy. In order to determine the effects of iNO therapy on survival and need for mechanical ventilation, cross-over will not be allowed.

This clinical trial will attempt to demonstrate if pre-term infants may benefit from treatment with nitric oxide for inhalation. A multi-center study is necessary to recruit an appropriate number of subjects, and to reflect the variability of standard practice across the different participating centers. All treatment assignments are blinded in order to minimize the risk of bias in treatment and data collection. In addition, a concurrent placebo group has been chosen as the most appropriate control group since there may be temporal, institutional and national variations in average outcomes. Methemoglobin levels will be measured locally and will collected in a blinded manner.

Eligibility Criteria:
Inclusion Criteria:

Preterm infants who:

* Are in-born at \< 30 weeks gestational age
* Weigh 500-1250 grams
* Have hypoxic respiratory failure requiring mechanical ventilation with FiO2 \> 0.8 to maintain SaO2 ≥ 85% in the first 48 hours after birth after use of exogenous surfactant
* Have minimal parenchymal lung disease by chest X ray

Exclusion Criteria:

Preterm infants who:

* Have ten minute Apgar score \< 5
* Have life-threatening anomalies (cardiac, thoracic, chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any child who will not receive complete intensive care
* Have bilateral Grade IV Intraventricular Hemorrhage (IVH)
* Are dependent on right to left shunting to maintain the systemic circulation
* Have received prior iNO therapy
* Have had treatment with investigational medications
Effect of Brivaracetam in Photosensitive Epileptic Subjects

to assess the effect of brivaracetam on the photoparoxysmal EEG response in photosensitive epileptic subjects


Eligibility Criteria:
Inclusion Criteria:

* epileptic subjects with generalized PPR

Exclusion Criteria:

* more than 2 concomitant antiepileptic drugs
A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

The primary objective of this study is to compare the efficacy of ABP 234 with the pembrolizumab reference product (Keytruda®).


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age.
2. Histologically or cytologically confirmed stage IV non-squamous Non-Small Cell Lung Cancer (NSCLC).
3. Participant has no prior systemic treatment for advanced disease.
4. Measurable disease according to RECIST v1.1.
5. Tumor tissue from the resected site of disease must be available for biomarker analyses in order to be randomized.
6. Eastern Cooperative Oncology Group performance status score 0 or 1.
7. Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and c-ros oncogene 1, receptor tyrosine kinase of the insulin receptor family (ROS-1) negative
8. Have a life expectancy of at least 3 months.

Exclusion Criteria:

1. Small cell lung cancer (SCLC) or mixed SCLC/NSCLC histology or squamous cell carcinoma.
2. Participant has active central nervous system metastases not previously treated.
3. Participant has active or known immune-mediated disorders.
4. Participant has received prior systemic cytotoxic chemotherapy, immunotherapy (including PD-1/PD-L1), anti-neoplastic biological therapy, or targeted therapy for advanced/metastatic disease.
5. Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug, or to any component of cisplatin, carboplatin, or pemetrexed.
Antimicrobial Hernia Repair Device Clinical Study

This prospective clinical study will evaluate the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected (i.e., Class II, Class III, and Class IV) surgical fields. Up to 30 patients will be treated with the Cook® Antimicrobial Hernia Repair Device and patients will be followed for 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Patient presents with a ventral or incisional hernia that is to be surgically corrected using open repair technique

Exclusion Criteria:

* Body Mass Index (BMI) \< 25.
* Body weight \< 45 kg
* Glycosylated Hemoglobin (Hgb A1c) \> 10%
* Albumin \< 2.5 g/dL or pre-albumin \< 5.0 mg/dL
* Renal insufficiency, as determined by an estimated glomerular filtration rate (GFR) \< 60 mL/min/1.73 m2
* Known allergies to study device components
* Other relevant exclusion criteria apply
Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects.

This three-part, Phase 1 protocol will be the first clinical study of AB-101. Parts 1 and 2 will be a Phase 1a SAD/MAD of AB-101 in healthy adult subjects.

Part 3 will be a Phase 1b dose-ranging assessment of AB-101 in non-cirrhotic Chronic Hepatitis B (CHB) subjects.


Eligibility Criteria:
Inclusion Criteria: Part 1 and 2 (Healthy Volunteers)

* Male between ages 18-50 years
* Willing and able to provide informed consent

Willing to follow protocol-specified contraception requirement

Inclusion Criteria: Part 3 (CHB Subjects)

* Male or female subjects between the ages of 18-60 years
* Willing to provide informed consent
* Chronic HBV infection for at least 6 months
* Willing to follow protocol-specified contraception requirement

Exclusion Criteria: Part 1 and 2 (Healthy Volunteers)

Key Exclusion Criteria:

* Clinically significant lab abnormalities
* A history of clinically significant gastrointestinal, hematologic, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, autoimmune or other immune-mediated disease.
* HIV or Hep C positive
* Known chronic or severe infection or recent significant exposure to infections such as tuberculosis or endemic mycosis, untreated latent infections like tuberculosis, or a positive or indeterminate QuantiFERON test.

Exclusion Criteria: Part 3 (CHB Subjects)

* Have extensive fibrosis or cirrhosis of the liver
* Have or had liver cancer (hepatocellular carcinoma)
* Have a history or current autoimmune disease or has been on immunosuppressive medications within 6 months of the start of the study
* Females who breastfeeding, pregnant or who wish to become pregnant during the study
* Known chronic or severe infection or recent significant exposure to infections such as tuberculosis or endemic mycosis, untreated latent infections like tuberculosis, or a positive or indeterminate QuantiFERON test.
Cross Correlation of Pain Hypersensitivity and Clinical Features and Electromyography in Low Back Pain Patients

Diagnostic and prognostic value of pain hypersensitivity in low back pain (LBP) is not fully understood.Increased pain sensitivity in the primary area of pain (local pain) is considered a sign of predominantly peripheral pain sensitization,value of pain hypersensitivity in low back pain (LBP)is not fully understood whereas pain sensitivity in distal and remote areas is considered to present a more central phenomenon. It is suggested that pat ents with enhanced pain sensitivity report high level of disability. Despite fact that pain and disability are associated in chronic LBP the exact mechanisms of sensitivity contribution in LBP disability is unknown. It has also been suggested that muscle function changes may be driven by pain. The possible role and contribution of trunk muscles function to pain and disability phenomena remain unknown.

This study was aimed to estimate prevalence and possible correlation among pain hypersensitivity and functional and electromyography parameters of trunk muscles in patients reporting early phase of chronic LBP.


Eligibility Criteria:
Inclusion Criteria:

* Low back pain for at least 12 weeks
* Magnetic resonance imaging (MRI) confirmation of prolapsed intervertebral disc (PID)
* No meeting excluding criteria.

Exclusion Criteria:

* No response to initial contact
* Red flag symptoms
* Diabetes mellitus,
* Neurological problems and
* Cancer
* Pregnant patients
* Patients treated chirurgically for the same problem or treated with oral corticosteroids and steroid injections for any reason in the previous month.
Multimodal MRI Study of Ischemic Stroke

Stroke is the second most frequent causes of mortality in the word after cardiovascular disease and the most frequent cause of disability. The majority of strokes are ischemic (87%). Ischemic stroke may benefit from efficient therapy if the delay from stroke onset not exceeds 4H30 (intra-venous thrombolysis). In case of irreversible cerebral lesion, the long term functional recovery is largely dependent from the ability of the brain to reorganize. Conventional magnetic resonance imaging represents the most sensitive tool to diagnose stroke at the acute phase. However, up to now, no imaging tool is available to determine the time of stroke onset. Moreover, no imaging tool is available to precisely quantify the functional and structural plasticity mechanisms occurring after stroke. The main objective of the present study is to test the accuracy of sodium MRI to determine the time of stroke onset. The secondary objectives of the study are to determine the ability of non-conventional MRI techniques to quantify the degree of tissue damage and brain reorganization after stroke. Thirty patients will be included during the first 24 hours after stroke onset. Multimodal MRI (including perfusion MRI, sodium MRI, resting-state functional MRI, high resolution anatomical MRI) and clinical evaluation will be carried on at the inclusion, after 24 hours, at 3 months and at 12 months.


Eligibility Criteria:
Inclusion Criteria:

- Patient having presented a cerebral infarct beforehand confirmed by the brain imaging

* Patient having presented a cerebral infarct the hour of the beginning of which is known with certainty and dating less than 24 hours
* Patient having presented a cerebral infarct the area(extent) of which is superior to 1,5 ml

Exclusion Criteria:

* Patients presenting the usual contraindications to the MRI (pacemaker, agitation, metallic brightness, claustrophobia etc.)
* Patients presenting a risk of not compliance to the examination: disorders(confusions) of the elementary understanding, the confusion, the involuntary movements, the bad tolerance of the prolonged dorsal decubitus
Prehabilitation and Rehabilitation for Patients With Oesophageal Cancer

Patients with oesophageal cancer selected for oncological and surgical treatment with curative intent are offered supervised physiotherapy and home-based training before and after surgery.

Patients with loco-regional oesophageal cancer who will receive neoadjuvant chemotherapy or chemoradiotherapy followed by surgery and sometimes adjuvant chemotherapy are eligible to be enrolled in the trial. Study treatment is supervised group training twice weekly and home-based training three times weekly during neoadjuvant treatment and after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma in the oesophagus or cardia (Siewert I or II), cT1 N+ or cT2-4a any N, M0, according to the 8th version of the AJCC TNM classification.
* Assessed at a multidisciplinary conference to be suitable for curatively intended oncological and surgical treatment.
* Age \> 18 years.
* Performance status ECOG 0-2.
* Patient has provided written informed consent.

Exclusion Criteria:

* Previous radiotherapy in the thorax (except for tangential field radiotherapy for breast cancer).
* Inability to understand written and spoken instructions and to comply with protocol requirements.
Assessment of Early Treatment Response by Diffusion and Perfusion MRI in Patients With Brain Metastasis

Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the body using magnetic field and radio frequency pulses that can not be felt. The purpose of this study is to determine if new imaging methods can help tumor evaluation in the brain. The extra images will be obtained using diffusion and perfusion MRI techniques to assess early treatment response in patients with brain metastasis, and will be compared to methods currently being used.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and over.
* Patients/Subjects able to give informed consent
* Patients/Subjects whose weight does not exceed 275 lbs.
* Patient with metastatic brain tumors greater than or equal to 1.0 cm that will be treated with stereotactic radiosurgery and scheduled for an MRI scan as part of their routine care

Exclusion Criteria:

* Patients who are unwilling or unable to undergo MRI including patients with contra-indications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips.
Effect of Pressure Support Ventilation During Anesthetic Emergence on Postoperative Atelectasis in Infant

Atelectasis occurs in patients of all ages who receive mechanical ventilation under general anesthesia, and although fatal cases are rare, it is known as a cause of postoperative hypoxia or fever. In pediatric patients, it has a particularly high incidence of 68-100%, and the incidence is inversely proportional to age. Pediatric patients,compared to adults, have a small capacity for functional residual capacity while a high metabolic demand, making them fundamentally vulnerable to hypoxia. Increased atelectasis during anesthesia causes hypoxia not only during anesthesia but also during recovery after anesthesia. Therefore, it is important to establish and apply a strategy to minimize the occurrence of atelectasis during mechanical ventilation under general anesthesia in pediatric patients. The aim of this study is to investigate whether pressure support ventilation at emergence period could reduce the incidence of postoperative atelectasis in infants undergoing surgery under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

1. infant patients aged 0 day to 13 month
2. American Society of Anesthesiologists (ASA) classification 1\~2 who are scheduled for elective surgery under general anesthesia

Exclusion Criteria:

1. patients with symptomatic bronchopulmonary dysplasia
2. patients with uncorrected congenital heart or pulmonary disease
3. Hemodynamically unstable requiring preoperative vasopressor administration
4. fever (\>37.5°) or URI symptoms on the day of surgery
Efficacy of Ocrelizumab in Autoimmune Encephalitis

This pilot study is a randomized, double-blind, placebo controlled study of the efficacy of ocrelizumab in autoimmune encephalitis. Subjects with new diagnosis of autoimmune encephalitis will be invited to enroll in this study. Subjects will be randomized to receive ocrelizumab (an anti-CD20 therapy) or matched placebo, and will undergo three infusions over a six month period. Subjects will complete clinical visits over the study period, during which safety monitoring and neuropsychological assessments will be performed to assess for signs of clinical worsening from encephalitis. The primary outcome of this study is the proportion of patients who fail to complete the twelve month period without clinical worsening, as defined by the protocol. Subjects who experience early clinical worsening during the study may be offered open-label treatment with ocrelizumab at the discretion of the investigators.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or greater
2. Able to obtain informed consent from patient or appropriate designee
3. Possible autoimmune encephalitis as defined by Table 1:

   1. Reasonable exclusion of alternative causes
   2. Subacute onset (\< 3 months) of memory deficits, altered consciousness, and/or psychiatric symptoms
   3. One or more of the following:

      * CSF (cerebrospinal fluid) pleocytosis (\>5 cells/µl corrected, if necessary, for traumatic lumbar puncture)
      * EEG (electroencephalogram) with epileptiform or focal slow wave abnormalities involving temporal lobes
      * Brain abnormalities on T2/FLAIR MRI restricted to the mesial temporal (limbic) lobes
      * Associated dyskinesias (faciobrachial dystonic movements or orofacial dyskinesias)
4. Completed initial treatment with iv steroids (at least 3000mg solumedrol) and plasma exchange (at least 3 exchanges) within the past 8 weeks
5. Presence of one (or more) of the following autoantibodies in serum or CSF

   * NMDA receptor
   * LGI1
   * CASPR2
   * DPPX

Exclusion Criteria:

1. Prior immunosuppression treatment in past year (other than steroids, intravenous immunoglobulin and plasma exchange)
2. Active malignancy requiring chemotherapy
3. Pregnancy
4. Evidence of active hepatitis or tuberculosis infection
5. Medical condition that (in investigators opinion) precludes the use of ocrelizumab
Agitation in the Acute Psychiatric Department

Agitation is associated with a number of acute psychiatric conditions, and frequent in acute psychiatric admissions. It is associated with violence towards others, and strongly associated with in-patient suicides.

The main aims of the study are to assess different clinical presentations of agitation at admittance, and to assess the consequences of these different clinical presentations during the first three days of the stay.

The patients are assessed with three rating scales (Components of agitation, The PANSS-EC, The Brøset Violence Checklist) measuring agitation at admittance and day three thus providing a measurement of the differences during three days of in-patient stay. Therapeutic measures and interventions taken are assessed daily with a 18-item checklist. Threatening and violent incidents are recorded with The SOAS-R.

Blood samples for immunological parameters are taken at admittance and discharge giving opportunity to assess changes through the acute psychiatric condition. Urine and blood samples are taken at admittance to assess substance use and medications.

The patients are assess with two self-rating VAS-scales at discharge assessing the suicidal intentions they have had during the stay, aspects of clinical history and assessment for personality disorders.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive acutely admitted in-patients are asked for participation.

Exclusion Criteria:

* Patients not willing to sign informed consent form.
* Patients not speaking English or Norwegian.
BIOFLOW-III Sweden Satellite Registry

This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to long-term complications range from rather immediate elastic recoil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30%-50%. Such rates of recurrence have serious economic consequences.

Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in de novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20%-40% of cases, necessitating repeat procedures.

The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilised on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in a better safety profile as compared to BMS with systemic drug administration.

These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease. This observational registry is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic coronary artery disease
* Subject has signed informed consent for data release
* Subject is geographically stable and willing to participate at all follow-up assessments
* Subject is ≥ 18 years

Exclusion Criteria:

* Subject did not sign informed consent for data release
* Pregnancy
* Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media
* Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained
* Currently participating in another study and primary endpoint is not reached yet.