cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of 24 Weeks of Oral Treatment With BIIL 284 BS in Adult and Pediatric Patients

The purpose of this study is to determine the effect of 24 weeks of treatment with BIIL 284 BS compared with placebo on pulmonary function and incidence of pulmonary exacerbation in adult and pediatric cystic fibrosis patients.


Eligibility Criteria:
INCLUSION CRITERIA:

* Male or female patients \>= 6 years pediatric 6-17 years inclusive; adult \>= 18 years)
* Body weight \>= 20 kg (determined at Visit 1)
* Confirmed diagnosis of CF
* Able to perform acceptable spirometric maneuvers, according to American Thoracic Society standards .
* FEV1 25-85% predicted
* Clinically stable
* The patient or the patient's legally acceptable representative must be able to give informed consent.
* The patient must be able to swallow the BIIL 284 BS tablets whole.
* Patients taking a chronic medication must be willing to continue this therapy for the entire duration of the study.

EXCLUSION CRITERIA:

* Patients with a significant history of allergy/hypersensitivity (including medication allergy) which is deemed relevant to the trial as judged by the Investigator. "Relevance" in this context refers to any increased risk of hypersensitivity reaction to trial medication; there are no specific issues of concern currently identified with respect to use of BIIL 284 BS in allergic patients per se.
* Patients who have participated in another study with an Investigational drug within one month or 6 half-lives (whichever is greater) preceding the screening visit.
* Patients with known relevant substance abuse, including alcohol or drug abuse.
* Female patients who are pregnant or lactating, including females who have a positive serum pregnancy test at screening (pregnancy tests will be performed for all females of child bearing potential).
* Female patients of child bearing potential who are not using a medically approved form of contraception.
* Patients who are unable to comply with food requirements prior to dosing.
* Patients with documented persistent colonization with Burkholderia cepacia.
* Patients chronically using oral corticosteroids or high-dose ibuprofen.
* Patients with hemoglobin \< 9.0 g/dL; platelets \< 100x10 to the 9th power/L; SGOT (ALT) or SGPT (AST) \> 2.5 times the upper limit of normal; creatinine \> 1.5 times upper limit normal.
* Clinically significant disease or medical condition other than Cystic Fibrosis or Cystic Fibrosis-related conditions that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data.
Acute and Cronic Evaluation of AV/PV and VV Delay IEGM Based Optimisation Algorithm-QuickSept Study

AtrioVentricular (AV) and InterVentricular (VV) delay optimization can improve ventricular function in Cardiac Resynchronization Therapy (CRT) and is usually performed by means of echocardiography. St Jude Medical has developed an automated algorhythm which calculates the optimal AV and VV delays (QuickOptTM) based on Intracardiac ElectroGrams, (IEGM), within 2 minutes. So far, the efficacy of the algorhythm has been tested acutely with standard lead position at right ventricular (RV) apex. Aim of this project is to evaluate the algorhythm performance in the mid- and long-term with RV lead located in mid-septum.

Primary end-point was to evaluate the relationship between the series of aortic flow Velocity Time Integral (aVTI) values calculated by the two methods at the PV, AV, and VV interval settings recommended by both the QuickOptTM and the standard ECHO optimization in CRT-D patients, at three index times: pre-discharge, at 6-month and at 12-month follow-ups.

Secondary end-point was to define the correlation between the optimal AV, PV and VV intervals defined by ECHO, using aVTI measurements and by the QuickOptTM algorithm, IEGM-based.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CRT-D
* stable and safe placement of an active-fixation RV lead on mid-interventricular septum;
* achievement of an efficacious LV intravenous pacing from a Coronary Sinus (CS) branch.

Exclusion Criteria:

* AF
* Patients without spontaneous rhythm
Fat Quality on Blood Lipids and Immune Response

The purpose of this study is to investigate blood LDL-cholesterol and level of inflammatory markers after intake of food items with different fatty acid composition.


Eligibility Criteria:
Inclusion Criteria:

* hsCRP \< 10 mg/L
* total cholesterol 5-7.8 mmol/l(50-70 y)
* total cholesterol 5.0-6.9 mmol/l (30-49 y)
* total cholesterol 5.0-6.1 mmol/l (25-29 y)
* LDL-cholesterol at or above 3.5 mmol/l
* triglycerides at or lower 2.6 mmol/l
* BMI 20-35
* Stable bodyweight last 3 months.

Exclusion Criteria:

* Chronic diseases
* fasting glucose \> 6.0 mmol/l
* increased ASAT and ALAT
* medications affecting lipidmetabolism and inflammation
Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing

The proposed clinical investigation plan is a pivotal controlled study with two parallel groups, has a total duration of 12 months and involves the recruitment of 34 pediatric patients suffering from acquired brain injury.

The primary objective of the clinical study is to evaluate the improvement of joint stiffness through the use of sensorized pseudoelastic orthoses for the rehabilitation of pediatric patients with acquired brain injury.

The effectiveness of the treatment in terms of joint stiffness (primary outcome) will be assessed and the effect of the treatment will be quantified with clinical evaluation scales and instrumental measurements by means of an optoelectronic system and isokinetic machine. The tolerability and acceptability of the device will also be checked.


Eligibility Criteria:
Inclusion Criteria:

1. Quadriplegia or acquired hemiplegia.
2. Age 6-20 years.
3. Dystonic, dyskinetic, spastic.
4. Chronic phase patients (\> 1 year post event).
5. Spastic syndrome with Ashworth Score (AS) for the limb of interest\> 1.
6. Collaborative.

Exclusion Criteria:

1. Fixed limitations of the joint.
2. Joint pain.
3. Skin allergies.
4. Behavioral and psychiatric disorders (eg, emotional problems, anxiety, panic attacks).
The Body Project: Comparing the Effectiveness of an In-person and Virtually Delivered Intervention.

This present study will compare the efficacy of in-person versus virtually-delivered Body Project groups. It will also evaluate whether this body acceptance class produces greater reductions in eating disorder risk factor symptoms (pursuit of the thin ideal, body dissatisfaction, dieting, dietary restraint, negative affect, eating disorder symptoms, and the future onset of eating disorders over a 3-month follow-up in this population. It will also evaluate the effectiveness of this body acceptance class's ability to impact social appearance anxiety, body compassion, and self-stigma surrounding attaining help.

Dozens of eating disorder prevention programs have been evaluated, but only the 4-hr Body Project has reduced eating disorder symptoms and future eating disorder onset over 3-4 year follow-up, produced larger reductions in outcomes than credible alternative interventions, been shown to engage the intervention target (valuation of the thin beauty ideal), and produced effects in trials from several independent teams. The proposed study will evaluate the effectiveness of a peer-implemented, virtually delivered, body acceptance class compared to a peer-implemented, in-person delivery of the same class. Participation in the intervention will last four weeks. Participants will be randomly assigned to the in-person or virtual body acceptance class. Assessments will take place at pre-intervention, post-intervention, and 3-month follow-up.

Eligibility Criteria:
Inclusion Criteria: Participants had to express body image concerns and all gender identities besides cisgender and transgender men were eligible.

Exclusion Criteria:

* Cisgender and transgender men were excluded due to the fact that The Body Project is typically administered with groups of all cisgender women.
Ultra-high Density Mapping With Multielectrode Catheter vs Conventional Point by Point Mapping for Ventricular Tachycardia Substrate Ablation

Ultra-high density mapping with multielectrode catheter may improve slow conduction channels identification in ventricular tachycardia substrate ablation procedures compared to conventional point by point mapping.

This study compares the ability of both mapping catheters to detect slow conduction channels in areas of myocardial scar and their utility to assess substrate modification after ablation.

This is a prospective, randomized controlled study. Twenty patients with sustained ventricular tachycardia and structurally abnormal ventricle(s) will be prospectively enrolled. In all patients a detailed pre and post-ablation electroanatomical mapping will be performed, and these maps will be merged with CT and/or MRI images. Patients will be randomly assigned to two groups. In Group A patients both pre and post-ablation mapping will be performed firstly by conventional point by point mapping using a Navistar Thermocool catheter, and secondly by multielectrode contact mapping using a Pentaray catheter. In this group, target ablation sites will be guided by point by point map. In Group B patients, both pre and post-ablation mapping will be performed firstly by multielectrode contact mapping using a Pentaray catheter, and secondly by conventional point by point mapping using a Navistar Thermocool catheter. In this group target ablation sites will be guided by multielectrode contact mapping.

Slow conduction channels will be identified by color-coded voltage map adjustment of the lower and upper thresholds and also the presence of fractioned electrograms with the delayed component showing sequential orthodromic activation. The entrances of these channels will be the target of the ablation sites (scar dechanneling technique).

Eligibility Criteria:
Inclusion Criteria:

* Patients with indication for ventricular tachycardia substrate ablation.

Exclusion Criteria:

* Pregnant woman.
* Reduced expectancy of life (less than 12 months)
* Patient participating in another clinical study that investigates a drug or device
* Psychologically unstable patient or denies to give informed consent
* Any cause that contraindicate ablation procedure or antiarrhythmic drug
Anisakis Blastocystis Cryptosporidium Fish Serology

Anisakidae frequently infect fish species that are commonly eaten by humans. Some of them are recognized as zoonotic diseases agents, and have a high impact on human health.

Infestation results from the ingestion of living larvae from contaminated fishes. It can be asymptomatic or symptomatic, resulting in acute gastric, acute intestinal or chronic forms. Allergic manifestations are frequently encountered in gastric forms, but allergic symptoms can also occur in isolation, after ingestion of Anisakidae antigens contained in raw or cooked fish, and may masquerade as fish allergy.

In this study, we aim to characterize the relationship between Anisakidae and/or fish sensitization and the presence of allergic manifestations in patients recruited in the general population and presenting fish allergy resulting from ingestion, cutaneous or respiratory contact. We will also determine the respective role of Anisakidae or fish sensitization in patients with fish allergy. Then, we will determine the prevalence of previous Anisakidae infections among these patients and a matched control population. We will also compare the performances of serological tests (ImmunoCAP, immunoelectrophoresis and Western Blot) for the diagnosis of Anisakidae allergy or infection. Lastly, we will explore the relationship between domestic exposure to Anisakidae or fish antigens and the occurrence of associated pathologies (Anisakidae or fish allergy/sensitization; Anisakidae infection).

First, 51 patients with fish allergy will be recruited from the Parasitology-Mycology and Immunology Laboratories of Lille University Hospital databases (serology for anti-Anisakis or anti-fish detection). Then, clinical (characteristics of allergic manifestations) and epidemiological (domestic exposure to fish) data will be collected, and anti-fish or Anti-Anisakis antibodies will be detected using ImmunoCAP (IgE), or ImmunoCAP, immunoelectrophoresis, Western Blot, respectively. Similar serological tests will be performed for a control group of 51 matched subjects who will be recruited among Lille University Hospital workers.

Eligibility Criteria:
Inclusion Criteria:

ALLERGIC PATIENTS:

* Previous serological assessment for anti-Anisakis or anti-fish antibodies detection (ImmunoCap and/or immunoelectrophoresis) in Lille University Hospital Center, and volume of serum conserved ≥500 µl
* Allergic manifestations after contact with fish (asthma, allergic rhinitis, conjunctivitis, chronic or acute urticaria, dermatitis/eczema, eosinophilic gastroenteritis, gingivostomatitis, angioedema, bronchospasm, anaphylaxis)

CONTROL SUBJECTS:

* Serological assessment for infectious disease during a routine occupational health consultation in Lille University Hospital Center
* Absence of fish allergy

Exclusion Criteria:

* Pregnant or breast-feeding female
* Patient with no social insurance
* Patient unwilling to comply with the protocol
* Patient unable to understand the study and its objectives
* Patient under guardianship
Clinical Performance of Chairside CAD/CAM Restorations

This investigation will be a longitudinal clinical trial to study the long-term clinical performance of a resin cement for chairside CAD/CAM restorations. Lithium disilicate chairside CAD/CAM onlays will be adhesively bonded using a selective enamel etch technique with an adhesive.

Full contour zirconia crowns will be cemented using a self-adhesive resin cement.

A wide variety of restorative materials are available for dental restorations. The most popular current materials include glass ceramics and full contour zirconia. Glass ceramic materials are generally preferred for their high translucency mimicking enamel-like esthetics of natural teeth and zirconia is preferred for high strength applications. Both of these materials are available for clinical treatment using chairside CAD/CAM technology.

The introduction of an induction sintering oven (SpeedFire oven/Dentsply Sirona) opened the opportunity for chairside full contour zirconia crowns by decreasing sintering times for zirconia to under 30 minutes. 3M Chairside Zirconia (3M) was marketed in 2019 and offers improved esthetics and high strength for monolithic zirconia restorations with an efficient processing time.

This investigation will be a longitudinal clinical trial to study the long-term clinical performance of CAD/CAM restorations. Lithium disilicate chairside CAD/CAM onlays (IPS emaxCAD/Ivoclar) will be adhesively bonded using a selective enamel etch technique with a universal adhesive (3M) and a resin cement (3M). Full contour zirconia crowns (3M Chairside Zirconia/3M) will be cemented using a self-adhesive technique.

Eligibility Criteria:
Inclusion Criteria:

* Subject in need of crown and/or onlay restoration
* Subject age 18 or above
* Subject with healthy / treated periodontal status (max. degree of movement 1)
* Subject agrees to participate in the study and signed informed consent and HIPAA form

Exclusion Criteria:

* Devital or sensitive teeth
* Teeth diagnosed with symptoms of incomplete tooth fracture
* Teeth with prior endodontic treatment of any kind
* Teeth with a history of direct or indirect pulp capping procedures
* Subjects with uncontrolled bruxism or parafunctional habits
* Subject has known allergies to any product used in this study
* Subject will not be available for the study duration
* Subjects with significant untreated dental disease to include periodontitis and rampant caries
* Pregnant or lactating women
Core Strengthening Versus Lower Limb Proprioceptive Neuromuscular Facilitation Techniques in Chronic Stroke Patients

Stroke is a global healthcare issue that causes increased death rates. Good trunk stability is essential for balance and extremity use during daily functional activities and higher-level tasks. The anticipatory activity of trunk muscles is impaired in stroke patients. The trunk is the central column of the body; therefore, proximal trunk control is a prerequisite for distal limb movement control, balance, and functional activities. The purpose of the study is to highlight the most appropriate rehabilitation technique for trunk stability.

A randomized clinical trial will be performed in which 42 patients with strokes will be included. The data will be collected from Riphah Rehabilitation center Lahore and Ittefaq hospital Lahore. Consecutive sampling technique will be used to collect data. The duration of the study will be 10 months. Trunk impairment scale and berg balance scale will be used as the data collection tool. Data collection will be started after taking informed consent from all the patients. Patients will be allocated to intervention groups by randomization. The patients in group A will be given core strengthening exercise for 4 weeks. The patient in group B will be given PNF exercise for the treatment of trunk for 4 weeks. After data collection analysis of pre and post values will be done by using SPSS version 25.

Eligibility Criteria:
Inclusion Criteria:

* Chronic stroke patients (6 months to 2 years).
* Participants with first ever ischemic stroke of right or left half of the body.
* Participants should be able to walk without support for 10 m.
* MMSE score is ≥ 24.

Exclusion Criteria:

* Participants with recurrent stroke; brainstem or cerebellar stroke or hemorrhagic stroke will be excluded.
* Patients with speech problem after stroke
* Patients with other neurological disorders including: Parkinson's disease, multiple sclerosis, epilepsy, etc.
A Trial to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Oral Semaglutide in Healthy Male Japanese and Caucasian Subjects

This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), pharmacodynamics (the effect of the investigated drug on the body), safety and tolerability of oral semaglutide in healthy male Japanese and Caucasian subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male Japanese and Caucasian subjects
* Age between 20 and 55 years (both inclusive) at time of signing informed consent
* Body weight of above or equal to 54.0 kg
* Body mass index (BMI) between 20.0 and 25.0 kg/m\^2 (both inclusive)
* Glycosylated haemoglobin A1c (HbA1c) below or equal to 6.0%

Exclusion Criteria:

* Presence or history of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, GI (gastrointestinal), endocrine, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders, as judged by the investigator. Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
* History of chronic pancreatitis or idiopathic acute pancreatitis
* Smoking of more than 5 cigarettes (including nicotine substitute products), or the equivalent, per day or unwilling to refrain from smoking whenever required for the trial procedure
* Use of prescription drugs within 3 weeks or 5 times the half-life, whichever is longer, prior to Visit 2 (Day 1), non-prescription drugs within 1 week prior to Visit 2 (Day 1). The use of vitamins and minerals, and the occasional use of paracetamol (acetaminophen) or acetylsalicylic acid are permitted
* Any blood drawn in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
* Previous GI surgery such as invasive and corrective procedures involving the oesophagus, stomach, duodenum, gallbladder (e.g., cholecystectomy), pancreas or intestinal resections. Exempt are subjects that underwent uncomplicated surgical and diagnostic procedures such as appendectomy, hernia surgery, polypectomy, biopsies, as wells as colonic and gastric endoscopy
Risk Factors and Outcomes in Coronary Chronic Total Occlusion

This study aims to assess the risk factors and evaluate the long-term outcomes of patients with coronary chronic total occlusion (CTO) treated with percutaneous coronary intervention or medical treatment.

Coronary artery disease (CAD) is still one of the major contributors to global mortality. CTO is a special lesion type of CAD, defined as complete occlusion of at least one major epicardial coronary artery more than 3 months. Compared to non-CTO patients, those with CTO have worse prognosis. The prognosis of CTO patients is related to many factors including the baseline characteristics, modality of treatment and the degree of coronary collateral formation. Figuring out the factors which can indicate the outcomes of CTO is essential to clinical decision making. In this single center, observational study, we collect patient's clinical characteristics and blood samples to investigate potential factors associated with the development of coronary collateral formation and outcomes in patents with stable coronary artery disease.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years; Patients with angina or silent ischemia and documented ischemia; Patients with CTO ≥ 3months

Exclusion Criteria:

* eGFR\<15mL/(min·1.73m2); Chronic heart failure with NYHA grade ≥3; Had a history of coronary artery bypass grafting; Had received a percutaneous coronary intervention within the prior 3 months; Malignant tumor or immune system disorders; Pulmonary heart disease
The Effects of Antibiotic Combinations on Stem Cells

The purpose of this study was to evaluate the indirect effects of antibiotic combinations. SCAP viability, proliferation and apoptosis of the cells were evaluated. Osteocalcin (BGLAP), dentin sialo phosphoprotein (DSPP) and alkaline phosphatase (ALPP) gene expression levels were also evaluated.

The purpose of this study was to evaluate the indirect effects of triple (TAP- ciprofloxacin, metronidazole and minocycline), double (DAP- ciprofloxacin and metronidazole) and modified triple antibiotic pastes (mTAP- ciprofloxacin, metronidazole and cefaclor) on mesenchmal stem cells derived from apical papilla (SCAP). SCAP were isolated from the impacted third molar teeth of the young adults. TAP, DAP and mTAP treatment (14-day medication and 28-day medication) were applied on SCAP and viability, proliferation and apoptosis of the cells were evaluated after four weeks. Osteocalcin (BGLAP), dentin sialo phosphoprotein (DSPP) and alkaline phosphatase (ALPP) gene expression levels were also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with open apex third molar teeth for extraction indication

Exclusion Criteria:

* Patients with mature apex third molar teeth for extraction indication