cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Romosozumab vs. Zoledronic Acid Effect in Patients With Spinal Cord Injury and Low Bone Mineral Density

This is a randomized study to determine the effects of monthly romosozumab for one year or one-time zoledronic acid on bone mineral density (BMD) and biochemical markers of bone formation and resorption, in patients with spinal cord injury (SCI) and low BMD.

This is a randomized open-label study to determine the effects of monthly romosozumab for 12 month or one-time zoledronic acid infusion on bone mineral density (BMD) and biochemical markers of bone formation and resorption, in patients with spinal cord injury (SCI) and low BMD.

Patients: Thirty women between 20-70 years of age with spinal cord injury and low bone mass (BMD T-score lower than -2.0 in at least one location: Lumbar Spine, Femoral Neck or Total Hip sites) will receive study medication.

Primary outcome:

Total hip BMD change during a one-year treatment period.

Secondary outcome:

Change in Femoral neck BMD at 12 months, Bone turnover markers change over time (3, 9 and 12 month): C-terminal telopeptide of type I collagen (CTX), N-terminal propeptide of type I procollagen (P1NP).

Study population:

Thirty women between 20-70 years of age with spinal cord injury that occurred more than 24 month ago and low bone mass (BMD T-score lower than -2.0 in at least one location: Lumbar Spine, Femoral Neck or Total Hip sites)

Eligibility Criteria:
Inclusion Criteria:

* BMD T-score ≤ -2.0 at the lumbar spine, total hip or femoral neck
* SCI of at least 24-month but less than 7 years duration,
* American Spinal Injury Association (ASIA) Impairment Scale A-C

Exclusion Criteria:

* myocardial infarction (MI) or stroke within the preceding year
* high cardiovascular risk, 10 years Framingham score over 20 %.
Effects of Neutrophil Extracellular Traps and Damage-associated Molecular Pattern Molecules on Long Term Use of Macrolides in Adults With Chronic Respiratory Disease

The purpose of this study is to investigate the effects of neutrophil extracellular traps and damage-associated molecular pattern molecules on long term use of macrolides in adults with chronic respiratory disease.

This study is a prospective, observational, non-interventional cohort study to explore investigate the effects of neutrophil extracellular traps and damage-associated molecular pattern molecules on long term use of macrolides in adults with chronic respiratory disease.The study subjects were adult patients with chronic respiratory disease who met the inclusion criteria in the outpatient department from August 2021 to August 2023. A face-to-face questionnaire survey was conducted. ACT score was used for asthma control evaluation. Baseline data such as pulmonary function, FeNO, blood routine, induced sputum cell count, etc. were obtained. The use of hormones and other drugs was recorded. Inflammatory biomarkers were detected. 20ml venous blood was drawn to extract neutrophils to detect the expression of neutrophil extracellular traps and RT-PCR and ELISA were used to detect the expression of DAMPs. The total study duration was 2 years, with telephone visits every 3 months to assess chronic respiratory disease control and record subject compliance, unscheduled outpatient, emergency, and inpatient status.

Eligibility Criteria:
Inclusion Criteria:

* 1）Age ≥ 18 years; 2）Gender: not limited; 3）Diagnosis of asthma according to GINA guidelines (version 2021). 4）COPD was diagnosed according to GOLD guidelines (version 2021). 5）ACOS was diagnosed according to the consensus criteria for asthma-chronic obstructive pulmonary overlap syndrome (version 2021).

Exclusion Criteria:

* 1) Acute heart failure, severe organ failure, malignant tumors; 2) Other lung diseases such as pulmonary infection，pulmonary hypertension,tumor which seriously affect lung function, sputum cell classifi cation and other test results; 3) Pregnancy and lactation; 4) Recent surgery history.
Distal Femur Fracture Nonunion - Statistical Analysis Plan

Here the investigators describe the statistical analysis plan for the study assessing the prediction of fracture nonunion leading to secondary surgery in patients with distal femur fractures.

See attached PDF.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 16 years
* AO/OTA type A or C distal femur fracture
* Fracture located on the metaphyseal area of the distal femur (square method)
* Operative treatment in the Helsinki University Hospital with a distal femur anatomic lateral locking plate
* Operative treatment within 1 month after trauma
* Operative treatment between years 2009 and 2018

Exclusion Criteria:

* Stress fracture
* Pathological fracture
* An epicondylar or subchondral fracture
* A ligament sprain in distal femur
* Treatment with a double-plating method or with both plate and nail
* Non-surgical treatment and patients who died before the treatment
* Treatment with an unconventional plate (other than distal femur plate)
* Patients whose follow-up criteria not fulfilled
Dimensional Changes in Single Crowns Supported by Short Transmucosal Implants With Diverging or Converging Neck Profiles in the Esthetic Zone

The goal of the present randomized clinical trial is to assess the long-term osseous and peri-implant soft tissue changes as well as the success rate of short implants (6 mm) with a converging collar with micro threads or a diverging polished collar placed in the esthetic zone of the maxilla on partially edentulous patients. The main questions it aims to answer are:

* what are the long-term bone and soft tissue changes around implants with a converging collar with micro threads compared to a diverging polished collar placed in the esthetic zone of the maxilla?
* What is the success rate of implants with a converging collar with micro threads compared to a diverging polished collar placed in the esthetic zone of the maxilla? Dental implants with a converging collar with micro threads or a diverging polished collar will be placed in the esthetic zone of the maxilla of the included participants and the measurements regarding the bone and soft tissue level will be compared.

The objectives of the present randomized clinical trial are to evaluate the clinical and radiographic changes over time of hard and soft tissues around implants with a convergent or divergent collar. Twenty volunteer participants with two edentulous regions in the maxillary esthetic zone (from the right second premolar to the left second premolar) will be included in the study. Two implants will be randomly installed, one with a convergent collar and one with a divergent collar. After 3 months of healing, individual crowns will be installed. At each visit the following parameters will be evaluated: plaque index, probing depth, bleeding on probing, the recession of the mucosal margin, intraoral radiographs, likewise control CBCT, and impressions will be performed. The visit will take place at 6 and 12 months and then annually for a minimum of 3 years. Changes at the level of the marginal bone will be assessed overtime on the radiographs. Dimensional changes will be clinically evaluated during control evaluations and later through digital impressions.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least two edentulous areas in the esthetic region of the maxilla (from right to left from second premolar to premolar, preferably first premolars and incisors)
* Alveolar bone ≥ 8 mm in height and ≥ 5 mm in thickness assessed on CBCT.
* Age of ≥ 21 years.
* Need for an implant-supported prosthetic restoration.
* Be in good general health with no contraindications to oral surgical procedures.
* Not be pregnant.
* Patients who agree to participate in the study and sign the informed consent.

Exclusion Criteria:

* The presence of any uncontrolled systemic disease.
* History of past or ongoing chemotherapeutic or radiotherapeutic treatments.
* Heavy smokers (\>10 cigarettes per day).
* Previous bone regeneration procedures in the area of interest
Preventing Respiratory Health Problems in Bakery Employees

The study is a follow-up of investigations done in the years 1999-2002 in bakery employees. The main purposes are to look at the associations between flour dust exposure and respiratory disease, and to find out the best ways to reduce the flour dust levels in the working environment.

Background and Methods:

Supported by the The Confederation of Norwegian Enterprise (CNBI) Working Environment Fund a follow-up study of 184 bakery workers in 5 bakeries was done in 2012, appr. 10 years after a similar study in 1999-2002. In addition a cross-sectional study in 2 other bakeries (one 'bread-factory', and a traditional bakery with three small bake shops) was added.

Altogether 253 participants, among them 61 former bakery workers, were investigated with use of questionnaires, allergy-testing (skin prick testing, and blood samples for specific IgE and total IgE), spirometry with reversibility testing, exhaled NO-measurement, and nasal measurements.

As in 1999-2002 an extensive exposure assessment was performed including personal samples of total dust (Gelman), inhalable dust (PAS6), as well as direct reading measurements of dust (Dust Track). A Job Exposure Matrix (JEM) was created enabling each participant to be assigned an exposure value of probable mean daily flour-dust exposure based on work-tasks and bakery.

Aim of study:

* Follow-up of the participants in the 1999-2002 study, both still active bakery workers and former workers, on health-status focusing on respiratory disease, sensitization to common and occupational allergens, level of sick-leave and reasons for quitting as a baker.
* Inclusion of 'new' bakery workers into the cohort as a cross-sectional study, and to compare health-status in two cross-sectional cohorts.
* To assess personal exposure to flour-dust among workers in 7 bakeries, as part of the cross-sectional study described above.
* To identify implemented flour-dust exposure reduction measures in bakeries participating in 1999-2002, and to assess the potential impact of these measures on the exposure to flour dust.

Eligibility Criteria:
Inclusion Criteria:

* Employed in a bakery for more than 6 months
* and/or participant of the investigations done in 1999-2002 in 6 bakeries
Sperm Pathology Samples and Morphokinetics

The embryo kinetics may be a new prognostic factor for choosing the embryos with the highest implantation potential. In order to identify the factors that may affect the rate of embryo cleavage, there are many studies about morphokinetics and culture medium, oxygen tension, oocyte quality or type of medication used for ovarian stimulation. However there are no published data with respect to the influence of semen quality in the embryo kinetic.

In this study The investigators propose that the sperm quality may has influence in the embryo division.


Eligibility Criteria:
Inclusion Criteria:

* Sperm samples with more than 15 mill/ml of sperms, more than 40% of mobile sperms
* Sperm samples with less than 5 mill/ml of sperms, less than 10% of mobile sperms

Exclusion Criteria:

* sperm samples between 5 to 15 mil/ml of sperms and between 10% to 40% of mobile sperms
Time and Type Dependent Evaluation of Different Techniques for Correction of Cleft Maxillary Hypoplasia

Maxillary hypoplasia in CLP deformities results from congenital reduction in midfacial growth and the effects of the surgical scar from CLP repair.Turvey et al. suggested that this disproportionate jaw growth is the biologic consequence of prior surgical intervention for closure of the soft tissues and is not related to the congenital cleft deformity, Midfacial hypoplasia is commonly treated by performing conventional Le Fort surgery to displace the maxilla anteriorly and stabilization afterward with rigid fixation along with orthodontics treatment. .

Midface hypoplasia cleft patient has the following characteristics: concave facial profile, inverted nasal tip, wide alar base, acute nasolabial angle, and excessive exposure of sclera. Intraoral findings are anterior and posterior crossbite, CLP, accentuated curve of Spee, Class III dental malocclusion, multiple missing teeth, oronasal communication, and residual cleft. Speech disturbances are also usually present due to velopharyngeal incompetency and oronasal communication.


Eligibility Criteria:
Inclusion Criteria:

* Cleft patients either cleft alveolus or cleft alveolus and palate.
* Surgically fit patients.
* Patients ready for orthognathic assessment undergoing either surgical or orthodontics correction.

Exclusion Criteria:

* Non- cleft cases .
* Previous correction.
* History of active infection or underlying disease such as hematologic disorders neoplasm, and immune deficiency.
* Patient refused to sign an informed consent.
A Study of the Effect of Multiple Doses of Rifampin on the Single Dose Pharmacokinetics of RO5424802

This single center, open-label, 3-period, fixed-sequence study will evaluate the effect of multiple oral doses of rifampin on the pharmacokinetics of a single oral dose of RO5424802 in healthy volunteers. Subjects will receive a single dose of RO5424802 on Days 1 and 17 and rifampin daily from Days 8 to Day 20.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers, 18 to 55 years of age inclusive. Healthy status will be defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, and a complete physical examination
* Body mass index (BMI) between 18 to 32 kg/m2 inclusive
* Nonsmoking subjects and former smoking subjects (who have not smoked for the past six months before first dosing)
* Female subjects must be surgically sterile or postmenopausal for the past year
* Male subjects and their partners of childbearing potential must be willing to use two effective methods of contraception, one of which must be a barrier method (e.g., condom) during the study and for 90 days after the last drug administration

Exclusion Criteria:

* Women of childbearing potential, pregnant or lactating women, or males with female partners who are pregnant or lactating
* Positive urine test for drugs of abuse, alcohol, or cotinine test at screening or prior to admission to the study unit
* Suspicion of regular consumption of drug(s) of abuse including marijuana
* Current smokers or subjects who have discontinued smoking less than six months prior to first dosing
* History (within three months of Screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol). Alcohol consumption will be prohibited 72 hours prior to entry in the clinical site center and throughout the entire study (including the washout period) until discharge
* Positive for hepatitis B, hepatitis C, or HIV infection
* Participation in an investigational drug or device study within 45 days or 5 half-lives (whichever time period is longer) or 6 months for biologic therapies prior to first dosing
* Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, absorption, distribution, metabolism or excretion of study medication, or that would, in the opinion of the PI, pose an unacceptable risk to the subject in this study
* History of hypersensitivity to any of the additives in the RO5424802 formulation (lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, sodium lauryl sulphate, magnesium stearate)
* Any history of hypersensitivity to or contraindication to the use of rifampin or other rifamycins or history of severe drug-related allergic reactions or hepatoxicity
Visualization of the Stomach During Fasting and Measurement of Intragastric Volume After Ingestion of Fluid: Feasibility and Application of Three Dimensional Ultrasound in Healthy Subjects

Aspiration pneumonia is a dreaded complication of anaesthesia because of its prevalence (1/3,886 cases in elective anaesthesia and 1/895 cases in emergency settings) and its high morbidity and mortality (3 to 9%). This chemical and/or infectious pneumonia is secondary to passage of the gastric contents into the unprotected upper airways during general anaesthesia. The prognosis depends on three factors: the presence of food debris, and the acidity and volume of the gastric contents. To prevent this complication, the French society of anaesthesia and intensive care recommends preoperative fasting rules and, in patients presenting risk factors for aspiration, the use of antacids and rapid sequence intubation. This preventive strategy is associated with certain adverse events: deferred operative procedures, discomfort and hypoglycaemia secondary to fasting, more frequent anaphylactic complications, and memory of anaesthetic induction.

Over recent years, ultrasound has become more widely used by anaesthetists for local anaesthesia, vascular catheterization, haemodynamic monitoring and, more recently, 2D ultrasound estimation of intragastric volume. However, 2D ultrasound estimation of intragastric volume presents several limitations: because of the complex shape of the stomach, this technique requires a long learning curve and the measured volume is poorly correlated with reference techniques (MRI and 99Tc scintigraphy). Two studies have recently measured intragastric volume by three dimensional ultrasound with promising results.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers over the age of 18 years employed by Amiens University Hospital and covered by French national health insurance.
* Fasting (last meal \> 6 hours and last drink of water, tea or coffee \> 2 hours)
* Signature of the free and informed written consent form.

Exclusion Criteria:

* Pregnant woman.
* Presence of diseases or treatments that alter (slow or accelerate) gastric emptying.
* Presence of swallowing disorders.
* History of gastric or supramesocolic surgery.
A Study to Compare to PK Characteristics and Safety Profiles Between AD-227 and Co-administration of AD-227A and AD-227B

Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-227 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body weight equal to or greater than 50kg (Female 45kg) and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
* The Age equal to or greater than 19 in healthy volunteers at the time of screening visit

Exclusion Criteria:

* Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
* Other exclusions applied
Development of Exercise Training Programme for Older People with Musculoskeletal Pain in the Community

The rate of musculoskeletal pain among older people is increasing worldwide and significantly impacts the quality of life. Regular exercise can help prevent and manage chronic musculoskeletal pain because older individuals who are not physically active may have less muscle strength and a higher risk of impairment and injury than physically active persons. As a result, a tailored exercise program may prevent the loss of health-related quality of life among diverse elderly. This study aimed to develop a structured exercise module and identify its effect on musculoskeletal pain and the quality of life of older adults.

Background: The rate of musculoskeletal pain among older people is increasing worldwide and significantly impacts the quality of life. Regular exercise can help prevent and manage chronic musculoskeletal pain because older individuals who are not physically active may have less muscle strength and a higher risk of impairment and injury than physically active persons. As a result, a tailored exercise program may prevent the loss of health-related quality of life among diverse elderly.

Objectives: This study aimed to develop a structured exercise module and identify its effect on musculoskeletal pain and the quality of life of older adults.

Method: A quasi-experimental study was conducted among 60 older adults who experienced musculoskeletal pain in the East Coast Malaysia; Pahang, Terengganu, and Kelantan between January and February 2021. A set of questionnaires contained three parts; Part A: Socio-demographic Background, Part B: Musculoskeletal Pain (Pain Score), and Part C: Functional Limitation. Data was collected using a self-administered questionnaire through an online survey. Data collection processes go through three phases. Phase I: pre-intervention phase, Phase II: intervention session, and Phase III: post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Older adults aged 60 years old and above
* Lives in East Malaysia; Pahang, Kelantan, and Terengganu
* Have the mental capacity to give informed consent
* Had musculoskeletal pain

Exclusion Criteria:

* Had severely impaired hearing and sight that may have affected their ability to use the self-report scales
* Had neurological diseases or cognitive impairment
* Had a recent self-reported history of stroke or major surgery (in the past 6 months).
Intraosseous With Intra-articular Injection of Platelet Rich Plasma in Treatment of Knee Osteoarthritis

The aim of this study was to compare the efficacy of treatment in three groups of patients with knee osteoarthritis (OA) given a combination of intraosseous with intra-articular injection of platelet rich plasma (PRP), intra-articular injection of PRP and a single application of hyaluronic acid (HA).

Methods Eighty-six patients from January 2015 to June 2015 with grade II to grade III knee osteoarthritis according to the Kellgren-Lawrence classification were randomly divided into 3 groups to receive either PRP or HA. Group A received intra-articular injection of PRP 2 ml combination with medial tibial plateau and medial femoral condyle injection of PRP 2 ml (once more 2 weeks later). Group B were treated with 2 ml of PRP intra-articular injection every 14 days for a total of two injections. Group C received intra-articular injection of hyaluronic acid 2 ml every 7 days for five injections. All patients were evaluated by the Visual Analogue Scale (VAS) and the Western Ontario and McMaster Universities (WOMAC) score before the treatment and at 1st, 3rd, 6th, 12th and 18th months.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral symptomatic knee with pain for at least 1 month or swelling.
* Radiographic findings of knee degeneration (Kellgren-Lawrence score of II - III).
* Age 40-73 years.
* Body mass index (BMI) 18-32.5).
* Knee stability without a severe trauma history.

Exclusion Criteria:

* Bilateral knee osteoarthritis indicative of treatment for both knees.
* Kellgren-Lawrence score greater than III.
* BMI \>32.
* Age \>73 years.
* Systemic autoimmune rheumatic diseases and blood disorders.
* Active immunosuppressive or anticoagulant therapy.
* Intra-articular injection to the knee within the previous 1 year or previous joint infection.
* use of corticosteroids for 3 weeks before the procedure.
* use of nonsteroidal anti-inflammatory drugs (NSAIDs) in the 3 weeks before treatment.