cyrilzakka/clinical-trials huggingface dataset:
The Norwegian Antirheumatic Drug Register

NOR-DMARD is a register-based longitudinal observational study of which the main objectives are to study the effectiveness of treatment of inflammatory joint diseases with biological disease modifying anti-rheumatic drugs (DMARDs) in clinical practice, by measuring disease activity, health related quality of life, function and joint damage, and to study the long-term safety of such treatment. Other objectives include the assessment of cost-effectiveness of treatment, to identify and and validate clinical, genetic and immunological predictors of efficacy and adverse events, to assess the impact of treatment with biological DMARDs on work participation and work productivity, to investigate different strategies for use of biological DMARDs, to assess the performance of different outcome measures, and to ensure a systematic and timely follow-up of patients treated with biological DMARDs.

This study is a modification, and an extension, of the NOR-DMARD study that was conducted in 5 Norwegian rheumatology departments in the period 2000-2012. The study includes a structured follow-up with study visits at baseline (start of biological drug) and after 3, 6, 12 months and every 12 months thereafter. Each study visit includes clinical assessment, patient-reported outcomes and measurement of acute-phase reactants. The data collection also includes blood samples for biobank at baseline and 3 months. Serious adverse events data will be systematically recorded, but other adverse events can also be retrieved by linkage to other registers.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Diagnosis of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, spondyloarthritis, adult juvenile idiopathic arthritis, undifferentiated arthritis, or any other inflammatory arthritis
* Clinical indication to start a new treatment with a biological disease modifying anti-rheumatic drug or a kinase inhibitor

Exclusion Criteria:

* Unwillingness or unability to give written informed consent
* Psychiatric or mental disorders, alcohol abuse or other abuse of substances, language barriers or other factors which makes adherence to the study protocol impossible
* Participation in blinded RCTs or other studies incompatible with the NOR-DMARD study protocol
Prostate Diffusion Imaging With Distortion Correction

There has been literature demonstrating the effectiveness of correcting these MRI images by using an additional measurement of the magnetic field, but the implied improvement in lesion detection in these common distorted regions in the prostate has yet to be shown.

We propose that introducing this distortion correction would greatly improve the DWI images used for tumour detection. For this study we propose testing this hypothesis as a primary objective, and as a secondary objective including additional b-values to further refine the ADC value. The study involves adding one additional distortion correcting scan to the standard clinical study, adding approximately 2 minutes to the study.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Aged 18 and over
* No contraindication to MR scanning
* Smokers and non-smokers
* Patients who have had a complete scan on the 3T scan MRI at Norfolk and Norwich University Hospital and have gone on to have a biopsy at the Norfolk and Norwich University Hospital

Exclusion Criteria:

* Previous diagnosis of prostate cancer, prostatic biopsy or treatment for prostate cancer
Rehabilitation Exercise and Education of Airway Clearance Technique in NTM-PD: A Prospective Cohort Study

* The goal of this observational study is to evaluate the effects of pulmonary rehabilitation and airway clearance education in adults with nontuberculous mycobacterial pulmonary disease (NTM-PD). The main questions it aims to answer are:

  * Does pulmonary rehabilitation and airway clearance training improve lung function, symptom relief, and quality of life in patients with NTM-PD?
  * Does this non-pharmacological intervention contribute to better sputum culture conversion rates?
* Participants will:

  * Undergo pulmonary rehabilitation and airway clearance training over an 8-week period (biweekly sessions).
  * Receive evaluations at baseline, during the intervention, and follow-up assessments at 2 months, 6 months, and final study visit.
  * Undergo tests including pulmonary function tests (PFT), symptom assessments, bacteriologic evaluations, radiographic imaging (CT/X-ray), and quality of life surveys (EQ-5D-5L, CAT score).
* This study aims to provide clinical evidence supporting the role of non-pharmacological treatments in the management of NTM-PD, potentially informing future treatment guidelines and improving patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age 20 years or older at the time of enrollment.
* Diagnosis of nontuberculous mycobacterial pulmonary disease (NTM-PD) according to the 2020 American Thoracic Society (ATS) guidelines.
* Identification of clinically significant NTM species, including:

Mycobacterium avium / Mycobacterium intracellulare / Mycobacterium abscessus / Mycobacterium massiliense / Mycobacterium kansasii /

* Able to undergo pulmonary rehabilitation and airway clearance training as part of the study protocol.
* Willing to provide written informed consent to participate in the study.

Exclusion Criteria:

* Currently pregnant or actively breastfeeding.
* Unable to participate in pulmonary rehabilitation due to severe mobility impairment or neuromuscular disorders.
* History of massive hemoptysis or other medical conditions where airway clearance techniques may be contraindicated.
Retrospective Chart Analysis in the Effective Use of FloSeal in Post-Operative Joint Replacements

The purpose of this analysis is to compare Hemoglobin and Hematocrit levels following total hip or knee arthroplasty. The utilization of FloSeal intraoperatively will improve hemostasis postoperatively. Decreasing bleeding time will decrease the drop in level of Hemoglobin and Hematocrit which usually occurs postoperatively.

Retrospective Analysis of charts on patients having undergone Total Hip or Total Knee Arthroplasty. During the patient's hospitalization, lab values of Hg and Hct will be recorded for further analysis. Preoperative levels will be also noted to establish baselines.

Primary Data interest will be Hemoglobin (Hgb) level documented during hospitalization along with Hematocrit (HCT) and Red Blood Cell (RBC) data also collected.

Secondary Data gathered will consist of the following:

* patient Demographics
* Component Profile
* Length of Stay
* Anesthesia used
* Anesthesiologist
* EBL
* drain type
* Amount of drainage fluid recorded at 12 hour increments until discharge
* Amount of FloSeal used
* Type of Arthroplasty

  500 patients in Total
* 100 Historical Control Patients, knees - no FloSeal (retrospective)
* 100 Patients, knees - 5mL FloSeal (retrospective)
* 100 Patients, knees- 10mL FloSeal (prospective)
* 100 Historical Control patients, hips-no FloSeal (retrospective)
* 100 retrospective patients, hips-5mL of FloSeal (retrospective

Patients scheduled for Total Knee Arthroplasty will be asked if they wish to participate in the part of the study utilizing 10mL of FloSeal. These patient will be consented and the their data will be retrospectively gathered.

Eligibility Criteria:
Inclusion Criteria:

* Total Knee and Total Hip Patients
* Surgical Time less than 2 hours

Exclusion Criteria:

* Patients who require greater than 2 hour surgeries
* Patients who are undergoing revision arthroplasty
* Patients with known allergies to materials of bovine origin
Immunogenicity of RSV Vaccines in Residents of Long-Term Care Facilities (LTCF)

This clinical trial is studying the newly licensed RSV vaccines in adults over age 60 years living in long-term care facilities (nursing homes) by comparing the immune response to their vaccine to adults over age 60 years living in the community.


Eligibility Criteria:
Inclusion Criteria:

* ≥60 years of age who live in skilled nursing facilities or reside independently in the community
* Life expectancy of \>6 months, as assessed by the investigator
* Able to sign informed consent or to provide consent via a legally authorized representative (LAR)

Exclusion Criteria:

* History of a current immunosuppressive condition or receipt of chemotherapy or other immunosuppressive or cytotoxic therapy, including chronic prednisone use of ≥ 20 mg/day for more than 14 days within 3 months of study vaccination
* History of hypersensitivity or reaction to any vaccine component
* Simultaneous administration of another vaccine (influenza, SARS-CoV-2) or within a 14-day window before or after intervention
* Previous receipt or intended receipt of an RSV vaccine outside the study
* Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.
* Documented RSV infection within 2 months prior to study intervention.
The Effect Of Multiple Occupational Therapies On Functional Remission And Subjective Recovery For Schizophrenia

Objective: This study aimed to evaluate the effect of multiple occupational therapies on functional remission and subjective recovery of individuals with schizophrenic disorder. Methods: 26 people with schizophrenic disorder were divided into two groups using a random number table. The intervention group participated in routine community mental health center services and a total of 24 sessions of occupational therapies three times a week, while the control group participated in routine community mental health center services.

Background: Occupational therapies are one of the psycho-social intervention methods used in the treatment of serious mental disorders characterized by disability, such as schizophrenia.

Objective: This study aimed to evaluate the effect of multiple occupational therapies on functional remission and subjective recovery of individuals with schizophrenic disorder.

Methods: 26 people with schizophrenic disorder were divided into two groups using a random number table. The intervention group participated in routine community mental health center services and a total of 24 sessions of occupational therapies three times a week, while the control group participated in routine community mental health center services. Data were collected using the Subjective Recovery Assessment Scale and the Functional Remission of General Schizophrenia Scale.

Eligibility Criteria:
Inclusion Criteria:

* Being in the 18-65 age group
* have been diagnosed with schizophrenia for at least one year
* be in remission of the disease
* volunteering to participate in research
* not have any physical health problems that would prevent their participation in the research

Exclusion Criteria:

* have a physical health problem that prevents participation in the research
* Having a communication problem
* not willing to participate in research
Dietary Supplementation to Increase Serum Choline Levels

The goal is to assess whether, in adult women during the luteal phase of their menstrual cycle, supplementing their diet with either phosphatidylcholine or betaine increases their serum choline levels.

Elevated maternal serum free choline has the potential to improve fetal brain development . However, in humans, choline can be metabolized by gut flora into two metabolites with adverse outcomes: trimethylurea (which causes body odor) and Trimethylamine (TMA) which is then, once absorbed, metabolized into Trimethylamine-N-Oxide (TMAO). There is some concern that TMAO may be atherogenic and thus, if elevated over an extended period of time, may increase risk for cardiac disease. Thus, while maternal choline supplementation may improve fetal brain development, there is a potential for maternal adverse effects.

However, humans have an active choline metabolic pathway, and other components of the choline metabolic pathway (e.g. phosphatidylcholine and betaine) may be interchangeable with choline post absorption but are resistant to gut bacteria metabolism (i.e. serum TMA does not increase). Thus, these other compounds would be expected to increase serum but with no impact on TMA or trimethylurea levels. An initial study of phosphatidylcholine supplementation in pregnant women was consistent with this hypothesis; infant offspring demonstrated improved cerebral inhibition; while no adverse events were identified for either mother or infant.

Unfortunately, because of the lipid groups incorporated into phosphatidylcholine, its molecular weight is high and reasonable doses require consuming several large capsules a day. The study represents the first attempt to determine if betaine, an alternative compound within the same metabolic pathway but with a much lower molecular weight, also increases serum choline levels. As the first step, this proposal seeks to address this in non-pregnant women. Specifically, the goals are to (a) assess whether changes in serum choline levels in response to molar equivalent supplementation of phosphatidylcholine versus betaine are similar, and (b) whether, for betaine, there is a dose response relationship between supplementation dose and serum choline levels.

Eligibility Criteria:
Inclusion Criteria:

1. premenopausal
2. No nicotine use
3. No marijuana use
4. No illicit substance use
5. Weight \>= 90 pounds

Exclusion Criteria:

1. self-reported body odor of unknown etiology
2. personal or family history of cystathionine beta synthase deficiency (homocystinuria)
3. personal or family history of trimethylaminuria, renal or liver disease, Parkinson's disease
Corneal Collagen Crosslinking and Intacs for Keratoconus and Ectasia

This study will determine the efficacy of corneal collagen crosslinking (CXL) combined with Intacs for the treatment of keratoconus and corneal ectasia. The goal of CXL is to decrease the progression of keratoconus, while Intacs has been shown to decrease corneal steepness in keratoconus. This study will attempt to determine the relative efficacy of the two procedures either performed at the same session versus CXL performed 3 months after Intacs.

The purpose of this is to ascertain the possible additive effect of the two treatments to both improve the quality of the corneal optics (i.e. improve corneal topography regularity) and to stabilize the cornea. Previous investigations have shown that Intacs surgery, indeed, does improve corneal topography and improve contact lens tolerance and spectacle corrected visual acuity, as well as uncorrected visual acuity in some patients. Investigations of CXL have shown the procedure not only to decrease keratoconus progression, but also to decrease the steepness of the cone and improve uncorrected and best corrected visual acuity in some cases. Since the mechanism of improvement differs between the procedures, this suggests a potential additive effect of the two on the patient's ultimate visual outcome. Thus, the patient would be afforded two potential benefits: (1) the potential of a more robust visual outcome and (2) stabilization of the keratoconic cornea on the longer term.

Eligibility Criteria:
Inclusion Criteria:

* 21 years of age or older
* Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery (e.g., LASIK, photorefractive keratectomy \[PRK\], or epi-LASIK)
* Subjects who meet the manufacturer's nomogram recommendations for Intacs segments
* Topography consistent with keratoconus or post-surgical corneal ectasia.
* BSCVA worse than 20/20 (\<55 letters on ETDRS chart)

Exclusion Criteria:

* Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme.
* Corneal pachymetry ≤ 400 microns at the thinnest point measured by Pentacam in the eye(s) to be treated when the isotonic riboflavin solution is used or ≤ 300 microns when the hypotonic riboflavin us used, provided that the corneal thickness after treatment with the hypotonic riboflavin solution is \> 400 microns. Corneal pachymetry ≤ 450 microns at the proposed insertion site for the Intacs
* Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications
* History of corneal disease
* History of chemical injury or delayed epithelial healing in the eye(s) to be treated.
* Pregnancy (including plan to become pregnant) or lactation during the course of the study
* A known sensitivity to study medications
* Subjects with nystagmus or any other condition that would prevent a steady gaze during the CXL and Intacs treatment or other diagnostic tests.
* Subjects with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
Gastric Cancer Risk Factors Associated With EU and CELAC Populations

The study uses a case-control design that examines the differences in types of exposures between cases defined with a pathological confirmation of GC diagnosis, and controls, defined as patients to whom a gastroscopy was indicated and confirmed absent of GC i

GC is associated to several known risk factors. Epidemiological and molecular features of GCs can vary widely. The reasons behind these differences are multiple and complex and may include genetic susceptibility, strains of the bacterium Helicobacter pylori (H. pylori), Epstein Barr virus infection, dietary factors and others. These factors can influence GC outcomes. There is little knowledge regarding how these risk factors are associated with GC in CELAC and EU populations.

The primary objectives of this study are to:

1. Identify risk factors associated with GC in the CELAC and EU populations participating in this study including Argentina, Spain, Mexico, Netherlands, Chile, Portugal and Paraguay.
2. Identify clinical, demographic, and epidemiological differences among the populations participating in this study

Eligibility Criteria:
Cases

* Inclusion criteria

  * Subjects ≥18 years old.
  * GC diagnosis (including gastroesophageal junction cancer) from IPATIMUP, INCAN, VUMC, PUC, VHIO, IAF, INCLIVA and GENPAT centres, in the last six months before his/her inclusion in the study.
  * Has given and signed the IC to participate in this study.
* Exclusion criteria:

  * Patients diagnosed with GC (including gastroesophageal junction cancer) from other centres/ countries not participating in this proposal.
  * Patients with suspected with GC diagnosis but not confirmed by the pathological report.

Controls

* Inclusion criteria

  * Subjects ≥18 years old.
  * Subjects to whom a gastroscopy was indicated in its medical care and confirmed absent of GC in the same centres will be matched in age (+/- 10 years), gender and pertaining from the same region of the GC case. Thus, to match our GC cases same number of controls is expected to be recruited.
  * Has given and signed the IC to participate in this study.
* Exclusion criteria:

  * Subjects from a different geographic area from the cases.
  * Patients with high suspicion of GC (including gastroesophageal junction cancer) or previous personal history known of document chronic gastritis diagnosed by endoscopy and confirmed by histology.
The Effect of Rhomboid Intercostal Block and Serratus Anterior Plane Block on Postoperative Respiratory Functions

Rhomboid intercostal block is used to block lateral cutaneous branches of intercostal nerves between T3 and T9 dermatomes. Serratus anterior plane block is used to block lateral cutaneous branches of intercostal nerves between T2 and T6, in addition, it is also known to block thoracodorsal nerve and long thoracic nerve. Both of the blocks are usually performed for postoperative analgesia following breast surgery. The primary hypothesis of the study is that FEV1 value of the patients who will receive modified radical mastectomy (MRM) and rhomboid intercostal plane (RIP) block combined with serratus anterior plane (SAP) will be higher than FEV1 value of the patients in the no-block group. The secondary hypothesis is that RIP+SAP blocks will provide reduction in the pain scores and opioid consumption in the postoperative first 24 hours.

The patients who are scheduled for MRM under general anesthesia, aged between 18-65 years and ASA scores I-II will be included in the study. Respiratory functions (FEV₁, FVC, FEV₁/FVC, PEF, FEF25-75) of the patients will be measured by a hand-held spirometry device prior to the operation in the surgical ward. The induction of anesthesia will be provided similarly in all patients, then patients will be intubated and randomly divided into two groups. One group will receive RIP+SAP block using 40 milliliters of %0.25 bupivacaine and patients in the control group will receive no block procedures. The standard analgesia will be provided by intraoperative intravenous (iv) infusion of dexketoprofen 50 mg and iv tramadol 1 mg/kg which will be administered in 15 minutes before end of the surgery. Respiratory functions of the patients will be measured at the postoperative 2nd, 4th and 24th hours. Pain intensity of the patients will be evaluated by Numerical Rating Scale (NRS) which is a scale ranges between 0 (no pain) and 10 (the worst pain that a person can stand). NRS scores will be evaluated at the postoperative 15th, 30th minutes and 1st, 2nd, 6th, 12th and 24th hours, and opioid consumption will be recorded at the postoperative 24th hour.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients
* Female
* Ages between 18-65
* Patients who will receive breast cancer surgery under general anesthesia

Exclusion Criteria:

* Known respiratory diseases
* Rhinitis and atopic dermatitis story
* New York Heart Association Class equal to higher than class 2
* Respiratory diseases story in the last two weeks
* Alchol or substance or chronic opioid consumption story
* Any pain killers intake in the last 24 hours prior to surgery
* Active smokers or ex-smokers
* Body mass index over 35 kg/m2
* İnfection at the injection sites
* Known allergy to local anesthetics
* Known psychiatric diseases
* Operations longer than 3 hours
Effect of Sodium Bicarbonate Buccal Infiltration on the Success of Inferior Alveolar Nerve Block

The purpose of this prospective, randomized, double blind study was to evaluate the effect of a buccal infiltration of sodium bicarbonate on the anesthetic success of the inferior alveolar nerve block (IANB) in patients with mandibular first molar experiencing symptomatic

Several studies have been done by adding Sodium Bicarbonate to local anesthesia in dentistry based on the theory that the amount of local anesthetic in the free-base un-ionized form will decrease to provide greater lipid penetration of the nerve and this could be cause of the failure of local anesthesia injected into the inflamed tissue with low PH and conflicting results were obtained. But, there are no study that evaluate effect of increasing PH in periradicular tissue on hindrance of resistance channels with supplementary infiltration injection of Sodium Bicarbonate

Eligibility Criteria:
Inclusion Criteria:

* vital mandibular molar tooth
* diagnosis of symptomatic irreversible pulpitis

Exclusion Criteria:

* younger than 18 years old
* history of significant medical conditions
* allergies to local anesthetics or sulfites
* pregnancy
* taking any medications that might influence anesthetic assessment
* active sites of pathosis in area of injection
* inability to give informed consent