cyrilzakka/clinical-trials huggingface dataset:
Specifying the Anti-inflammatory Effects of Ziltivekimab

The goal of this randomized, double blind, placebo controlled trial is to study whether ziltivekimab therapy reduces arterial wall inflammation as assessed by imaging, and reduces the systemic inflammatory tone as assessed by circulating monocytes, inflammatory biomarkers and proteomics.

Considering that ziltivekimab is currently undergoing a phase 3 CVOT trial, it is of great importance to elucidate its mechanistic effects. The objective of this study is to research whether ziltivekimab therapy for 20 weeks reduces arterial wall inflammation, as assessed by state-of-the-art imaging modalities, and reduces systemic inflammatory tone, as assessed by in depth phenotyping of circulating monocytes, inflammatory biomarkers and proteomics. The imaging modalities used in this study are 68Ga-DOTATATE PET/CT and CCTA. This study is designed as a single center, randomized, double-blinded, placebo-controlled intervention study in 40 atherosclerotic patients of 50 years and older with hsCRP levels of 2 mg/L and above.

Eligibility Criteria:
Inclusion Criteria:

* Aged 50 years and older.
* Multi-vessel coronary artery disease (defined as CAD-RADS ≥2).
* Serum hsCRP level ≥2 mg/L.

Exclusion Criteria:

* Coronary stents in situ.
* Chronic or recent (\<1 month) (serious) infections and/or clinical signs of acute (serious) infection.
* History of severe auto-immune diseases, or other (severe) (recurrent or chronic) inflammatory disorders.
* Use of preventive systemic antibiotics (antibiotics used to treat latent tuberculosis are exempted).
* Stable lipid lowering treatment for less than 4 weeks, including statins, ezetimibe and PCSK9 inhibition.
* Untreated latent tuberculosis, active hepatitis B (positive HBsAg and/or positive anti-HBc with detectable HBV DNA) or C, human immunodeficiency virus (HIV) not on stable antiretroviral regimen
* Uncontrolled diabetes (HbA1c \>90 mmol/mol).
* Renal insufficiency, defined as eGFR \<45 ml/min/1.73 m2.
* Platelet count \<120,000 and \>450,000 /mm3.
* Elevated liver enzymes (\>3 ULN of liver transaminases), acute liver failure or known (severe) liver disease.
* Premenopausal women not using birth-control.
* History of gastrointestinal perforation, active diverticulitis (within 5 years) or active inflammatory bowel disease (within 12 months).
* Uncontrolled hypertension (systolic \>180 mmHg; diastolic \>110 mmHg).
* Diagnosis of (active) malignancy in last 5 years.
* Standard contra-indications to 68Ga-DOTATATE PET, and CT based on physician's experience and current practices.
* Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
Safety And Efficacy In Long Term Use Of Lyrica (Regulatory Post Marketing Commitment Plan)

The objective of this investigation is to evaluate the safety and efficacy of long term use with Lyrica in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Lyrica will be monitored during the survey period, and whether an additional treatment outcome investigation and/or a post-marketing clinical study is required in the future will be determined.

Patients who fulfill criteria below:

1. Patients who have previously enrolled in A0081261.
2. Patients who have been administered Lyrica for more than 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients need to be administered by Lyrica for over 52 weeks in order to be enrolled in the surveillance.

Exclusion Criteria:

* Patients not administered Lyrica.
Open Label Study of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine

This study is an open-label extension study to evaluate the safety, tolerability and efficacy of BOTOX® as headache prophylaxis in Chinese patients with chronic migraine who have successfully completed the double-blind study: 1313-301-008.


Eligibility Criteria:
Inclusion Criteria:

-Has successfully completed the double-blind study (1313-301-008).

Exclusion Criteria:

* Has met any of the withdrawal criteria in the double-blind study or has clinical significant abnormal laboratory or electrocardiogram (ECG) findings
* Headache attributable to another disorder (eg, cervical dystonia, craniotomy, head/neck trauma)
* Any medical condition that may put the patient at increased risk with exposure to Botulinum Toxin Type A, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.
Pilot Trial of a System for Motor Function Recovery

This is a multi-center, prospective, blinded, pilot feasibility study to evaluate improvement in sensory and motor function with sham.


Eligibility Criteria:
Inclusion Criteria:

* Traumatic chronic spinal cord injury

Exclusion Criteria:

* Active implanted medical device
* Internal metallic objects of unknown or foreign origin
* Implanted anti-spasticity pumps, Botox injections in prior 3 months or other current anti-spasticity regimen
* BMI \> 40.0
* Acute medical conditions under active treatment that would contraindicate standard rehabilitation including open wounds
* Pregnancy or planned pregnancy
* Unhealed bone fractures, peripheral neuropathies or painful musculoskeletal dysfunction
* Cardiopulmonary disease or ventilator dependency
* Uncontrolled epilepsy or seizures
* Clinically significant depression, psychiatric disorders or ongoing substance abuse
Ginkgo Biloba Extract and the Insulin Resistance Syndrome

The purpose of this study is to examine whether the ingestion of the herbal dietary supplement Ginkgo biloba extract has any effect on the efficacy of three classes of diabetic medications - (Glucotrol, Glucophage and Actose). Additionally, the study will examine the effect of Ginkgo biloba extract on pancreatic insulin production in non-diabetic subjects between the ages of 20 and 75 years old.

Herbal remedy is popular among those with chronic diseases, who may already be taking several prescription medications, thereby increasing the risk of drug-herb interactions. Ginkgo biloba extract is a popular dietary supplement that is ingested by the general population to enhance mental focus and by the elderly to delay onset of age-acquired loss of cognitive function. In subjects with non-insulin dependent diabetes (NIDDM), ingestion of Ginkgo biloba may decrease efficacy of the hypoglycemic agents and increase whole body insulin resistance. Because aging is a significant risk factor for the development of NIDDM as a result of a progressive decline in pancreatic function, and because the elderly chronically take multiple prescription medications, the increased use of Ginkgo biloba in this population may increase drug-herb interactions. Therefore, we shall examine the effect of Ginkgo biloba on the pancreatic function in the elderly to determine whether it may produce pancreatic dysfunction and a potential for the development of insulinopenia. The results of this study should provide valuable information for designing new therapeutic strategies for the treatment of diseases in the insulin resistance syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes mellitus and taking oral diabetes medications - Glucotrol, Glucophage and Actose or Avandia
* Must be able to swallow
* Healthy individuals without diabetes aged 20 to 80 years of age

Exclusion Criteria:

* Type 1 diabetes mellitus
* Type 2 diabetes mellitus taking insulin injections
* Regular use of anti-inflammatory drugs
* Chronic anemia
Dutch Cangrelor Registry

Cangrelor is a fast and directly acting platelet aggregation inhibitor. It is potentially indicated for several types of patients who are undergoing PCI. A nationwide cangrelor registry has up until now not been performed and with the introduction of cangrelor in the Netherlands its efficacy and safety will be determined.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* One of the following criteria:
* Patients naïve for P2Y12 inhibition undergoing PCI
* Patients with suboptimal P2Y12 inhibition undergoing PCI (patients who vomited after P2Y12 loading, out of hospital cardiac arrest (OHCA) patients with restoration of spontaneous circulation (ROSC), patients loaded with P2Y12 inhibitors though platelet inhibition still insufficient (\<2 hours after oral loading dose)
* (N)STEMI patients loaded with P2Y12 inhibitors with large thrombus burden (thrombus grade 4 or 5) on initial coronary angiography (CAG) and undergoing primary PCI with expected insufficient P2Y12 inhibition

Exclusion Criteria:

* Patients on current/chronic treatment with P2Y12 inhibitors
* Patients (pre) treated with a GPI
* Patients with recent major bleeding complications or contraindication to dual antiplatelet therapy:
* hypersensitivity or allergy to and known contra-indication for aspirin, clopidogrel, ticagrelor or cangrelor
* history of major clinical bleeding or known coagulopathy
* active bleeding
* history of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke
* known severe liver dysfunction
* Patients that received any organ transplant or are on a waiting list for any organ transplant
* Patients undergoing dialysis
* Pregnant or lactating female
* Patients currently participating in another investigational drug or device study
Etoposide, Oxaliplatin and Capecitabine in Advanced Hepatocellular Carcinoma (HCC)

Various cytotoxic agents have been evaluated in advanced hepatocellular carcinoma, but response rates have been low with significant toxicity, most often due to parenchymal liver disease. The three agents etoposide, oxaliplatin and capecitabine each has sparse efficacy as single agents, but the combination may act synergistically with an acceptable toxicity profile.

Design:

Open phase II study.

Purpose:

Response rate for the combination of etoposide, oxaliplatin and capecitabine given every 3 weeks on an outpatient basis.

Secondary endpoint are safety, time to progression and survival

Treatment:

Etoposide are administered intravenously 100 mg/m2 on day 1 and orally 200 mg/m2 on days 2 and 3.

Capecitabine (Xeloda) are administered 1000 mg/m2 twice daily with 12 hours interval for two weeks and one week off

Oxaliplatin are administered intravenously 100 mg/m2 on day 1 in each cycle as a 2 hours infusion.

One cycle is 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Histologically verified intra- or extrahepatic inoperable hepatocellular carcinoma or hyperdense liver lesion at computed tomography and concurrent elevated alpha-feto-protein \> 400 ng/ml
* PS 0-2
* Age 18-75
* Life expectancy \> 12 weeks
* Normal bone marrow function (neutrophiles \> 1,5 x 109/l and platelets \> 100 x 109/l)
* Bilirubin \< 2 x UNL
* Transaminases \< 3 x UNL
* Normal renal function, Cr-EDTA clearance \> 50 ml/min
* No chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion
* No uncontrolled, severe concurrent medical disease
* Fertile women must have a negative pregnancy test
* Fertile women must use adequate contraceptives during and 3 months after trial exposure
* Signed informed consent

Exclusion Criteria:

* Chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion
* Experimental therapy \< 8 weeks prior to inclusion
* Known DPD-deficiency
* Known neuropathy
* Uncontrolled, severe concurrent medical disease
* Prior malignancy during the last 5 years, except for non-melanoma skin cancer and carcinoma in situ cervix uteri.
The Influence of Output on Skin Covered by Adhesive With Topfilm

The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive with topfilm and a standard adhesive with a topfilm.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had an ileostomy for more than one year
4. Have intact skin on the area used in the evaluation
5. Has an ileostomy with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
5. Participating in other interventional clinical investigations or have previously participated in this evaluation -
Effect of a Brace on the Adolescent Idiopathic Scoliosis Breathing

This study intends to investigate the effect of bracing on respiratory function in the treatment of adolescent idiopathic scoliosis (AIS). In particular, it will look at the effect of the brace on respiratory function and 3D volume of the thoracic cage. An additional evaluation of the pressure forces of the brace, using a connected t-shirt, will be carried out. The investigators hypothesise that the brace will decrease the respiratory parameters and 3D volume of the thoracic cage, especially during deep breathing.

Scoliosis is a 3D deformity of the spine with curvatures occurring in the three planes of space.

The brace is widely used for adolescent idiopathic scoliosis. The Cheneau-Toulouse-Munster (CTM) brace is a rigid brace, classically indicated for thoracic and lumbar curves. However, scoliosis induces structural deformation of the rib cage. This can lead to changes in thoracic volume associated with a respiratory disorder, mainly restrictive. But the effect of bracing on pulmonary function currently remains unclear.

Few studies in the literature have looked at the impact of the brace on lung function. In those studies, the findings were based on Pulmonary Function Test (PFT) results only. In the CTM biomec study, the investigators propose to evaluate lung function by PFT associated with biplanar radiography using EOS® system, which allows 3D modelling of the rib cage. An additional evaluation of the pressure forces of the CTM brace, using a connected t-shirt, will be carried out to better understand the biomechanics of the brace. It will allow us to observe the stress surfaces on the thorax during the respiratory cycle and to compare them with the adaptation kinematics of the thoracic cage.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent girls aged 12 to 16
* With a right thoracic or thoraco-lumbar curvature (right and left)
* With a Cobb angle between 20 and 40°.
* Treated with a Cheneau-Toulouse-Munster brace for more than 1 month
* With a duration of brace wearing of more than 12/24h
* Affiliated to a social security system

Exclusion Criteria:

* Male gender
* Having a secondary scoliosis (neuromuscular, syndromic, post-traumatic, congenital pathology)
* Having a respiratory pathology prior to the diagnosis of scoliosis
* Have a history of spinal surgery
* Having already benefited from a brace treatment
Feasibility of Semaglutide in Advanced Lung Disease

The goal of this clinical trial is to learn whether semaglutide, an FDA-approved treatment for diabetes and obesity, is feasible and tolerable in patients with advanced lung disease.

The main question\[s\] it aims to answer are:

1. Are patients with advanced lung disease able to tolerate semaglutide therapy?
2. Are we able to titrate semaglutide therapy to a target weight?

Participants will be asked to perform pulmonary function, physical function and body composition testing, as well as a blood draw before and after 12-weeks of semaglutide therapy. While on therapy, subjects will be surveyed regarding any adverse events or side effects.

This is a small open-label pilot clinical trial of semaglutide in adults (age 18 or older, n=8) with obesity (BMI≥30 kg/m2), and chronic advanced lung disease (interstitial lung disease, sarcoidosis, chronic obstructive pulmonary disease, or pulmonary hypertension requiring supplemental oxygen on exertion). This study will evaluate medication adherence and side effects to determine semaglutide tolerability. Markers of physical function and pulmonary function will be evaluated before therapy and after 12 weeks of therapy to determine the effect of semaglutide on function. Measures of fat and muscle, will be performed before therapy and after 12 weeks of therapy to evaluate how semaglutide alters body composition in this population. Study participants will be monitored for 12 weeks while receiving semaglutide therapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of one of the following lung diseases: interstitial lung disease, sarcoidosis, chronic obstructive pulmonary disease, or pulmonary hypertension
* Age \> 18
* BMI \> 30 kg/m2
* Requires supplemental oxygen on exertion
* Stable treatment regimen X 90 days
* Use of disease-modifying therapy

Exclusion Criteria:

* Diabetes
* Pregnant or Breastfeeding
* Recent weight loss
* Recent or chronic GI complaints
* History of gastroparesis
* History of scleroderma
* Hospitalized at time of evaluation
* Use of weight loss medication in last 90 days
* Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia (type 2)
* Uncontrolled thyroid disease
* History of acute/chronic pancreatitis
* Prior suicide attempt
* Suicidal ideation in last 90 days
* Presence of a pacemaker or defibrillator
Safety and Efficacy of Intravenous Natalizumab in Acute Ischemic Stroke

The primary objective of the study is to assess the clinical effects of natalizumab versus placebo in acute ischemic stroke on clinical measures of functional independence and activities of daily living. The secondary objective of the study is to explore dose and exposure response and the clinical treatment effects of natalizumab versus placebo in acute ischemic stroke on the following: measures of independence, activities of daily living, neurologic function, quality of life, cognition, and safety and tolerability


Eligibility Criteria:
Key Inclusion Criteria:

* Clinical diagnosis of supratentorial acute ischemic stroke defined by LKN ≤24 hours prior to study treatment initiation.
* Score of 5 to 23 points, inclusive, on the NIHSS at Screening for subjects initiating treatment ≤9 hours from LKN. Note: NIHSS eligibility must be confirmed within 60 minutes prior to randomization.
* Score of 5 to 15 points, inclusive, on the NIHSS at Screening for subjects initiating treatment \>9 to ≤24 hours from LKN. Note: NIHSS eligibility must be confirmed within 60 minutes prior to randomization.
* Prior to index stroke, patient was able to perform basic activities of daily living without assistance: dressing, eating, walking, bathing, and using the toilet.
* For those subjects who underwent a cranial MRI, there is at least 1 acute infarct with a diameter of ≥2 cm on baseline brain diffusion-weighted imaging.

Key Exclusion Criteria:

* Lacunar or isolated brainstem or cerebellar stroke based on clinical assessment and available acute imaging studies performed under the standard of care.
* Presence of acute intracranial hemorrhage on acute brain CT or MRI. However, petechial hemorrhages of ≤1 cm are not exclusionary.
* Severe stroke defined by imaging criteria based on either one of the following:
* Alberta Stroke Program Early CT (ASPECT) score of 0 to 4 based on head CT or
* Acute infarct volume on MRI diffusion weighed imaging greater than or equal to 70 mL
* Seizure at the onset of stroke.
* Known history of prior treatment with natalizumab.
* Known history of active viral hepatitis B or C.
* Signs and symptoms of active or acute infection.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Efficacy and Safety of NicVAX® Co-administered With Varenicline (Champix®)

The purpose of this study is to evaluate the efficacy and safety of NicVAX co-administered with varenicline as an aid in smoking cessation over a one-year period in smokers who want to quit smoking.


Eligibility Criteria:
Inclusion Criteria:

* Smokes at least 10 cigarettes per day
* Good general health
* Negative pregnancy test prior to study entry

Exclusion Criteria:

* Prior exposure to NicVAX or any other nicotine vaccine
* Known allergic reaction to alum or any of the components of the vaccine
* Use of systemic steroids, immunosuppressive agents or other medication that might interfere with an immune response
* Cancer or cancer treatment in the last 5 years
* HIV infection
* History of drug or alcohol abuse or dependence within 12 months
* Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease
* Previous intolerance to varenicline
* Inability to fulfill all visits for approximately 54 weeks
A Clinical Trial to Assess Three Different Doses of OPS-2071 in Patients With Bacterial Enteritis

To assess safety, efficacy and pharmacokinetics of multiple dosesin patients with Bacterial Enteritis caused by Clostridium difficile infection(CDI) or Enteric infection.


Eligibility Criteria:
Inclusion Criteria:

* The patient provides written, informed consent before the clinical trial is initiated
* The patient has distinctive symptoms and findings of bacterial enteritis
* The patient has bacterial enteritis with one or more of the following causative pathogens either proven or presumed: C. difficile, Salmonella, Campylobacter, pathogenic E. coli, and other bacteria estimated to cause bacterial enteritis
* The patient and his/her partner are willing to take contraceptive measures from initiation of investigational medicinal products (IMPs) to 4 weeks after administration of IMPs

Exclusion Criteria:

* The patient has severe or progressive underlying disease or complication, making it difficult to ensure safety in the study or proper efficacy assessment
* The patient has a current diagnosis or history of convulsive disorders, such as convulsion and epilepsy
* The patient has a severe hepatic dysfunction
* The patient has a severe cardiac dysfunction
* The patient has cardiac arrhythmia or congenital or sporadic long QTc syndrome. Or the patient is treated with a drug reported to prolong QTc interval
* The patient has a moderate or severe renal dysfunction
* Women with confirmed or suspected pregnancy or breast-feeding women
* Patients judged to be ineligible by the investigator for any other reasons
Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer

The purpose of this study is to compare the combination of pemetrexed and carboplatin with the combination of docetaxel and carboplatin in terms of survival without Grade 3 or 4 toxicity in previously untreated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Patient with locally advanced or metastatic (Stage IIIB/IV) NCSLC with no prior chemotherapy for advanced disease or molecular target treatment
* Easter Cooperative Oncology Group (ECOG) performance status 0 to 2
* Estimated life expectancy of at least 8 weeks

Exclusion Criteria:

* Known or suspected brain metastases
* Concurrent administration of any other tumor therapy
* Serious concomitant disorders
* Pregnancy or breast feeding
* Inability or unwillingness to take folic acid or vitamin B12 supplementation