cyrilzakka/clinical-trials huggingface dataset:
Predicting and Monitoring Outcomes in Autoimmune Encephalitis

Epilepsy is a disorder of the brain in which people have repeated seizures.

Autoimmune encephalitis (AE) is a rare cause of epilepsy. It is an inflammatory disease of the brain. This means that the body's own immune system attacks healthy brain tissue, just like it would if it were infected by a virus or a bacteria, by producing an army of proteins called 'antibodies' which go on to 'attack' healthy tissues.

Seizures in AE typically do not respond well to classic 'anti-seizure medications'. Instead, medications which suppress the immune system are used. These can have significant side-effects and some patients will still continue to have seizures or experience a recurrence of AE-related epilepsy despite treatment. It is difficult to accurately predict who will experience these outcomes.

This study aims to find ways of predicting and monitoring which people with AE are at greatest risk of these outcomes, so we can better direct them towards appropriate treatments. We will collect clinical information and samples of blood and cerebrospinal fluid (CSF, fluid surrounding the brain and spinal cord) from people with AE and 'control' participants with other neurological illnesses. Samples will be analysed for markers which may help predict or correlate with outcomes in AE and better understand this condition.


Eligibility Criteria:
Inclusion Criteria:

* AE participants over the age of 18 will be recruited if they meet the criteria for clinically probable or clinically definite Autoimmune Encephalitis as per Graus and colleagues 2016.
* Neurological Control participants undergoing lumbar puncture as part of clinical care for other, non-encephalitis disorders (e.g. for investigation of headache where meningitis or encephalitis is not detected, for investigation and treatment of idiopathic intracranial hypertension) in Beaumont hospital will be recruited.

Exclusion Criteria:

AE participants

* Under 18 years of age
* Participants without AE or those with a definitive alternate diagnosis for presentation.

Other neurological control participants will be excluded if they have a current or historic diagnosis of AE.
LTFU Study of Subjects Who Received GRNOPC1

This is a LTFU study for thoracic SCI subjects that were administered GRNOPC1 cells in the main study CP35A007.

Study CP35A008 is a Phase 1, multi-center long term follow-up (LTFU) study for five (5) subjects with complete thoracic SCI that were administered 2 million GRNOPC1 cells in the main study CP35A007. The purpose of this study is to monitor long-term safety in subjects for 15 years post GRNOPC1 administration.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who received administration of GRNOPC1 under clinical study protocol CP35A007.

Exclusion Criteria:

* There are no exclusion criteria for this LTFU study.
Rheumatic IMmune-Related Adverse Events in Patients Treated With Immune Check Point Inhibitors

RIMRA is a prospective, longitudinal, observational study including patients with de novo symptoms of rheumatic disease or a flare of established rheumatic disease after treatment with an immune check point inhibitor. The aim of the study is to describe the clinical presentation, disease course and outcome of rheumatic irAEs in patients treated with immune check point inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* De novo symptoms of rheumatic disease or a flare of established rheumatic disease after \>/= 1 dose of treatment with an immune check point inhibitor
* Adult patients (\> 18 years)
* Subject capable of understanding and signing an informed consent form

Exclusion Criteria:

• Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol difficult
A Relative Bioavailability Study of Moexipril HCl 15 mg Tablets Under Fasting Conditions

The purpose of this study is to compare the relative bioavailability of Moexipril HCl 15mg tablets (by Paddock Laboratories, Inc.) with that of Univasc® 15mg tablets (by Schwarz Pharma) following a single oral dose (1 x 15mg tablet) in healthy, adult subjects under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* Good health as determined by lack of clinically significant abnormalities in health assessment performed at screening

Exclusion Criteria:

* Positive test results for HIV or Hepatitis B or C
* History of allergy or sensitivity to Moexipril HCl or related drugs
A Study of Perturbation of Human Small Intestinal Colonic Permeability

The purpose of this study is to evaluate the effect of castor oil versus placebo on intestinal permeability in healthy individuals.

Randomized, parallel-group, placebo-controlled, blinded, dose-response study using Castor oil and see the effects it has on small bowel and colonic permeability measured in healthy female and male adults.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-obese, non-pregnant volunteers.
* 1:1 Male/Female Ratio.
* BMI \< 30 kg/m\^2.

Exclusion Criteria:

* Diabetes.
* Uncontrolled hypertension (with BP measured \> 140/90mmHg in the CRTU)
* BMI ≥ 30 kg/m\^2.
* Chronic NSAID use (\> 1 day/week).
* Use of oral antibiotics for 2 weeks prior to and during the entire 5 day study period.
* Known intolerance of castor oil.
* Diagnosis of gastrointestinal diseases that are associated with abnormal intestinal or colonic permeability such as inflammatory bowel diseases, irritable bowel syndrome and celiac disease.
* Prior intestinal or colonic resection.
* Participation in highly vigorous exercise such as running \> 5 miles per day in week prior to the permeability test.
Superior Capsular Reconstruction Versus. Partial Repair for Irreparable Rotator Cuff Tears

Rotator cuff tear is one of the common injuries that cause shoulder pain in the elderly. After the rotator cuff tendon is injured, repairing the torn rotator cuff tendon through arthroscopic surgery is an effective treatment that is currently widely used. In the rotator cuff injury, irreparable rotator cuff injury is a difficult point in treatment, especially for patients with a long injury time, the obvious shrinkage of the injured tendon, muscle atrophy and steatosis may occur, all of which lead to the poor quality of the rotator cuff tendon needed to be repaired , Poor healing ability, seriously affecting the shoulder joint function and daily life of these patients. For this part of patients, arthroscopic partial repair of torn rotator cuffs is one of the commonly used methods. In addition, in recent years, superior capsular reconstruction has been gradually applied to the clinic and has achieved good clinical effects, but there are no controlled studies to compare Clinical effect of partial repair and superior capsular reconstruction on irreparable rotator cuff injury.


Eligibility Criteria:
Inclusion Criteria:

* patients with Irreparable Rotator Cuff Tears
* underwent superior capsular reconstruction or partial repair
* at least two years follow-up

Exclusion Criteria:

* reparable Rotator Cuff Tears
* underwent reverse total shoulder arthroplasty
COVID-19 Neurological Disease: A Prospective Study

Background: Recent reports increasingly recognize neurological manifestations in COVID-19 patients. However, the full spectrum of the disease and risk factors are not well understood.

Aim: To describe the full spectrum of neurological manifestations in COVID-19 and assess the clinical characteristics, risks and prognostic factors.

Outcomes: Identification of COVID-19 associated neurological disease is the primary outcome while requirement for admission to critical care unit, mortality, length of hospital stay, quality of life, and neurological disability are the secondary outcomes.

Participants: Patients above Age more than 18 years enrolled based on new-onset acute neurological disease and COVID19 positive will serve as cases while patient with confirmed COVID-19 without neurological manifestation will serve as controls.

Design and Procedures: The study is prospective case control in design and is divided into three phases in India, Brazil and Malawi ; the first phase will address role of hypoxia in causation of neurological diseases, the second phase will compare characteristics of patients hospitalized with COVID-19 with and without neurological disease and the third phase will assess the long-term follow up (at 3 months and 9 months) of cases.


Eligibility Criteria:
Cases

Inclusion criteria:

1. Confirmed or probable new-onset acute neurological disease (according to study definitions) AND
2. Confirmed or probable COVID-19 (according to study definitions), diagnosed using tests performed no later than 5 days after presentation with neurological disease

Exclusion criteria (any of):

* Age \<18 years
* Neurological features are explained fully by a previous neurological disease
* PCR test performed \>5 days after admission to hospital, in the absence of clinical illness meeting criteria for suspected COVID-19 (to exclude those with hospital-acquired infection).
* Enrolled on the basis of new-onset acute neurological disease, but subsequently does not meet definition for probable or confirmed COVID-19.

Controls

Two controls with non-neurological COVID-19 will be recruited per case.

They will meet all of the following criteria:

* Adults, no more than 5 years younger or older than the case.
* Enrolled at a similar time since admission to hospital as the case, defined as: \<7 days; 7-13 days inclusive; or ≥14 days.
* Hospitalised patients with confirmed or probable COVID-19 (according to study definitions)
* Not meeting criteria for confirmed or probable new-onset acute neurological disease (according to study definitions).

Some potential controls may be reclassified as cases if they develop neurological manifestations at up to 30 days after admission to hospital.
Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Eczema/Dermatitis and Dermal Pruritus (MK-4117-202)

This is an efficacy and safety study of up to 12 weeks of desloratadine in Japanese participants with eczema/dermatitis and dermal pruritus. The primary hypothesis of this study is that the sum of the daytime and nighttime pruritus/itch scores for both the eczema/dermatitis group and the dermal pruritus group will be significantly improved at Week 2 compared to Baseline.


Eligibility Criteria:
Inclusion Criteria:

* Eczema/dermatitis (acute eczema, chronic eczema, contact dermatitis, atopic dermatitis, nummular eczema, seborrheic dermatitis, asteatotic eczema, neurodermatitis, etc. among eczema/dermatitis for which the observation of pruritus is appropriate)
* Dermal pruritus (generalized dermal pruritus, localized dermal pruritus)

Exclusion Criteria:

* Hypersensitivity to antihistamines or ingredients of a study drug
Effects of ITB Myofascial Release on Symptoms Associated With Knee OA.

The aim of this randomized controlled trial is to determine the effects of ITB myofascial release with graston technique on symptoms associated with knee Osteoarthritis for reducing pain, enhancing knee range of motion and decrease functional disability.

Graston technique, Instrument assisted soft tissue mobilization (IASTM) also known as myofascial release technique is a skilled myofascial intervention used for soft-tissue treatment. Graston is a myofascial release tool that decreases adhesions, trigger points and tension in muscles. Graston Technique on Iliotibial Band Syndrome resulted in a decrease in subjective symptoms and an improvement in muscle function.

Eligibility Criteria:
Inclusion Criteria:

* knee OA Grade 2 and Grade 3 according to kellgren and Lawrence grading scale
* Positive Ober's test

Exclusion Criteria:

* Patient with cardiovascular or medical illness.
* Patient with any severe trauma or surgery of knee.
* Knee deformity
* Low back pain with or without radiculopathy.
* Neurological illness
* Participants having any wound or scar on the site of treatment.
* Pregnant female
* Participants having co-morbidities such as neoplasm etc.
Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection for Urogenital Cancer

After the treatment of urogenital cancer, a person may develop lymphoedema of the leg(s) and/ or midline region. Lymphoedema is the result of a dysfunction in the lymphatic system and is characterized by excessive retention of lymphatic fluid in the interstitial compartment, adipose deposition and chronic tissue inflammation resulting in fibrosis. Clinical symptoms include abnormal tissue swelling, sensation of limb heaviness, erythema, pain, and impaired limb function.

The added value of manual lymph drainage, applied in patients with mild (early) lower limb lymphoedema and in addition to skin care, exercises and a compression stocking, has never been investigated.

Therefore, the objective of this randomised controlled pilot trial is to investigate the feasibility of a trial about the added value of manual lymph drainage (to skin care, exercises and wearing compression stocking) in patients with mild (early) lower limb lymphoedema. In fact, the investigators want to determine the sample size for a trial investigating the effectiveness of MLD and want to investigate the feasibility of the study design.


Eligibility Criteria:
Inclusion Criteria:

* Patients included in the prospective observational study and developing lymphoedema within the first year after surgery
* Before inclusion, written informed consent must be given according to ICH/GCP, and national/local regulations.

Inclusion criteria of the prospective observational study were:

* Non-metastatic urogenital cancer (i.e. prostate cancer or bladder cancer)
* Pelvic lymph node dissection

Exclusion Criteria: same as for the prospective observational study:

* Radiological evidence of metastatic disease based on pelvic CT/MRI and bone scan
* Clinical signs of chronic venous insufficiency
Study of Tamibarotene in Patients With ADPKD

Clinical trial of tamibarotene in patients with Autosomal Dominant Polycystic Kidney Disease


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as ADPKD by modified Pei-Ravine
* eGFR(CKD-EPI) is equal to or greater than 60 mL/min/1.73m\^2
* Patients who are judged to be hard to treat with tolvaptan or who do not wish to be treated with tolvaptan, at the time of obtaining consent
* Patients with systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg. For patients receiving angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists, the dose must be constant for at least 6 weeks before obtaining informed consent

Exclusion Criteria:

* Women who are pregnant or may be pregnant
* Nursing mother
* Females with childbearing potential or male subjects with a fertile partner who is unable to use contraception for the following periods:

  1. Female: From informed consent to 2 years after the last administration of the study drug
  2. Male: From informed consent to 6 months after the last administration of the study drug
* Patients within 12 weeks from the last dose of a drug that affects renal cysts, such as tolvaptan, to the first dose of the study drug
* Patients with complications of intracranial aneurysm, malignant tumor, uncontrolled diabetes, osteoporosis, uncontrolled dyslipidemia, or abnormal liver function
Ultrasound High BMI Study

This is a prospective experimental pilot study of full-term non-emergent obese parturients whose labor is being managed with epidural anesthesia to determine if neuraxial block placement with pre-procedure handheld ultrasound affects time to placement or number of needle passes. Approximately 25 patients, presenting for delivery at the University of Kentucky HealthCare Obstetrics Department, will be randomized to either the ultrasound or palpation group, between study approval and 31 July 2022.

Placement of neuraxial blocks is commonly achieved by palpating surface landmarks. This somewhat "blind" technique to identify the spinal space becomes more difficult and less reliable in obese patients. Ultrasound devices have become common and successful with blocks and venous access, both involving mostly soft tissues. Application of conventional ultrasound for neuraxial blocks has been limited by its bulkiness, limited imaging for bony structures and a long learning curve. A newly developed pocket-size ultrasound addresses these limitations by providing real-time pattern recognition for spinal bony structures and 3D overlay for recognition of midline spinous process and intervertebral space using an automated artificial intelligent algorithm. The hypothesis is that ultrasound guidance will reduce time to epidural placement and reduce number of passes in obese patients.

Eligibility Criteria:
Inclusion Criteria:

* Subject requesting and consenting for a labor epidural, aged 18-50 and BMI between 35-59.9 at admission for labor.
* Subject with American Society of Anesthesiologists score equal to or less than III.
* Subject with singleton gestation equal to or greater than 37 weeks.
* Subjects with planned labor epidural in sitting position.

Exclusion Criteria:

* Patients with urgent or emergent diagnoses involving the health of the patient or child, such as abnormal fetal heart tracing.
* Patients with major back abnormalities (back surgery, significant scoliosis).
* Patients with contra-indication to neuraxial block (bleeding risk, local anesthetic allergy).
* Patients having cesarean section or combined spinal epidural.
* Patients whose epidurals are performed by residents in first month of obstetric rotation and/or having performed fewer than 20 labor epidurals in total.
* Patient needing a translator for procedure.
* Patients who are prisoners.
Travatan Z in Ocular Surface Health in Patients With Open-Angle Glaucoma or Ocular Hypertension

The purpose of the study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older.
* Ocular Surface Disease Index (OSDI) score and corneal fluorescein staining score as specified in protocol.
* Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
* Intraocular pressure (IOP) controlled with latanoprost 0.005% (XALATAN®) for at least one continuous month prior to Visit 1.
* Willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study, including artificial tears.
* Best corrected visual acuity of -0.6 logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any medical condition (systemic or ophthalmic) that may preclude safe administration of the test article.
* Use of contact lenses within 30 days of Visit 1.
* Use of contact lenses during the study.
* Participation in an investigational drug or device study within 30 days of entering this study.
* Other protocol-defined exclusion criteria may apply.
Liposomal Bupivacaine Versus Standard Bupivacaine in the Adductor Canal for Total Knee Arthroplasty

Study will evaluate the effect of liposomal bupivacaine versus standard bupivacaine on physical therapy measures and pain scores as well as opiate consumption.

Total knee arthroplasty (TKA) can be associated with a large amount of postoperative pain. This pain can oftentimes be severe enough to limit participation in physical therapy and ultimately delay discharge resulting in increased cost. Several strategies have been developed in an effort to decrease postoperative pain following TKA while maintaining lower extremity strength and maximizing participation in physical therapy. Recently, adductor canal blockade has gained popularity as it is reported to provide analgesia to the anterior knee without resulting in significant quadriceps muscle weakness. One downside of single shot peripheral blockade is the duration of analgesia can oftentimes be short lived. The advent of depot local anesthetics has made this an attractive option, especially in busy practices where placing peri-neural catheters may not be practical or cost effective. This study aims to carefully evaluate this relationship using a physical therapy evaluation method that relies on both motor strength and pain control. In addition, we hope to carefully evaluate motor strength using a novel method of strength measurement in an effort to further evaluate the impact of depot local anesthetic injection into the adductor canal on physical therapy and analgesia.

Eligibility Criteria:
Inclusion Criteria:

1. The subject is scheduled for elective unilateral TKA;
2. The subject is ≥ 18 years and ≤ 80 years;
3. The subject's weight is between 65-130 kg;
4. The subject's primary anesthesia care team has planned for a neuraxial anesthetic (i.e. spinal, epidural or combined-spinal epidural);
5. The patient agrees to receive an adductor canal block;
6. American Society of Anesthesiologists class 1-3.

Exclusion Criteria:

1. Subject is \< 18 years of age or \>80 years of age;
2. Subject is non-English speaking;
3. Subject is known or believed to be pregnant;
4. Subject is a prisoner;
5. Subject has impaired decision-making capacity per discretion of the Investigator;
6. Symptomatic untreated gastroesophageal reflux or otherwise at risk for perioperative aspiration;
7. Any condition for which the primary anesthesia care team deems neuraxial anesthesia inappropriate;
8. Significant pre-existing neuropathy on the operative limb;
9. Significant renal, cardiac or hepatic disease per discretion of the investigator;
10. American Society of Anesthesiologists class 4-5;
11. Known hypersensitivity and/or allergies to local anesthetics;
12. Chronic Opioid Use (daily or almost daily use of opioids for \> 3 months).
Study Evaluating Etanercept in Patients With Rheumatoid Arthritis Who Completed Trial 0881A1-301-EU in Spain

The purpose of this study is to evaluate long-term safety of etanercept in patients with rheumatoid arthritis who successfully have completed open-label safety study 0881A1-301-EU


Eligibility Criteria:
Inclusion Criteria:

* To have completed 0881A1-301-EU study in Spain
* Clinical diagnosis by ACR revised criteria of rheumatoid arthritis.

Exclusion Criteria:

* Hypersensibility to etanercept or any of its components
* Significant concurrent medical disease
Evaluation on the Efficacy of Bronchodilator Nebulization Via High Flow Nasal Cannula

High-humidity nasal cannula (HFNC) has been shown to be effective in improving oxygenation and avoiding intubation in multiple randomized control trials, it is also suitable and feasible for long term use. Aerosol delivery via HFNC will minimize interruptions and improve patient compliance, bench study and radionuclide imaging study done in healthy volunteers demonstrated that aerosol can be effectively delivered using HFNC. This study aims to evaluate the efficacy of bronchodilator delivered via HFNC in chronic pulmonary obstructive disease or asthma patients.

Chronic obstructive pulmonary disease or asthma patients who have positive response in bronchodilator test will be consented and enrolled, patients come back for the second bronchodilator assessment within one to three days after the initial bronchodilator test. Albuterol with different concentration will be provided to the patients via HFNC, patients will be assessed by spirometry after each concentration until bronchodilator response is positive and does not improve after the next dose.

Eligibility Criteria:
Inclusion Criteria:

* Diagnose with COPD or asthma
* Bronchodilator test is positive (According to ATS guidelines, FEV1 change from initial more than 12% and FEV1 absolute change more than 200 mL);
* Age \> 18yrs and \< 90yrs

Exclusion Criteria:

* Recent pulmonary exacerbation
* Mental disease
* Uncooperative
* Reluctant to participate
* Patients who are unable to come back to get the second spirometry within three days
* Contraindicated to Albuterol (Ventolin, GSK)

  * Rest HR \> 100 beats/min
  * Serum K+ \< 2.8 mmol/L