cyrilzakka/clinical-trials huggingface dataset:
Celebrex and HO Study

The primary goal of this observational study is to demonstrate the incidence of heterotopic ossification (HO) in patients with cementless total hip joint replacement surgery over time and secondly, demonstrate the relationship between celecoxib and HO formation. Lastly, investigators will examine the relationship between HO and patient-reported outcome measures (PROMs).

Heterotopic ossification (HO) is characterized by the pathologic formation of mature lamellar bone in muscle and soft tissue. It presents clinically with localized pain, reduced motion, and swelling. The process of HO occurs due to abnormal tissue repair, and most commonly occurs in young adults. Significant predisposing factors include total hip arthroplasty (THA), fractures, spinal cord and traumatic brain injuries, and thermal injuries. The overall incidence of HO is up 42% to 57% after THA, and the incidence of extensive HO post THA is 2% to 7%. Certain patient and surgical-related factors have been associated with an increased risk of HO. Patient aspects include a history of Paget's disease, ankylosing spondylitis, and hypertrophic osteoarthritis; surgical factors include the use of cemented implants and prolonged time of ischemia. Post-operative celecoxib use has been associated with a significant lower incidence of HO compared to controls. Furthermore, among COX-2 selective inhibitors, celecoxib has been associated with the lowest incidence of HO.

This study looks at patients who have been referred to our orthopaedic clinic and undergone cementless total hip joint replacement surgery through a retrospective review of our pre-existing departmental database. All the data from all patients who meet the inclusion criteria will be collected from our database. Specifically, the age, gender, BMI, pre-operative diagnosis, post operative radiotherapy, preoperative patient-reported outcome measures (PROMs), post-operative PROMs, operative characteristics, and complications. Data from the available PROMs database will need to be converted into a manageable format that is suitable for data analysis. This study looks at the Harris Hip Score, the UCLA Activity Score, and SF-12 PROMs that are collected from each patient as standard of care. Descriptive statistics and para/nonparametric statistics will be used to analyze the data through IBM SPSS software platform for statistical analysis. The independent student t-test and multivariable logistic regression analysis will be used to examine outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* All primary total hip replacements with Cementless Tri-lock BPS (Depuy, Warsaw, IN) with minimum 2 years follow up.

Exclusion Criteria:

* Revision surgery
* Infections
* Other implants
CA125 Levels and Other Inflammatory Markers in Laparoscopic Ventral Hernia Repair

The study aims to show variation in CA-125 and other inflammatory markers assumed to be a response to trauma and peritoneal inflammation in the perioperative period of laparoscopic ventral hernia repair

CA-125 and other inflammatory markers as body temperature, CRP, PCT, leucocytes and neutrophils measured pre- and post-operatively - correlated to trauma size i.e. area of dissection, mesh size, number of fixation points etc.

Eligibility Criteria:
Inclusion Criteria:

* Adults admitted for ventral or incisional hernia repair

Exclusion Criteria:

* Loss-of-domain
* ASA above III
* Liver failure
* Abnormal CA-125 prior to surgery
Biofeedback Training on Shoulder Muscles Strength Post Mastectomy

PURPOSE:The purpose of the study is to evaluate the effect of biofeedback on shoulder muscles strength post mastectomy.

BACKGROUND:

* The most common complications following mastectomy are pain, ipsilateral lymphedema of the upper limb (UL), reduced range of motion (ROM) of the shoulder, flexion and abduction is limited to 90°, and external rotation is limited to 40°, and there are postural changes
* One of the most common complications after breast cancer surgery is a functional limitation of the upper body. Up to 67% of breast cancer patients experience arm or shoulder impairment, including pain, numbness, loss of strength, and reduced ROM, after surgery
* Shoulder problems in breast cancer patients affect their daily activities, such as pulling a sweater overhead, fastening a bra, zipping up a back zipper, reaching overhead, and carrying heavy bags.
* Biofeedback is a mind-body technique in which individuals learn how to modify their physiology for the purpose of improving physical, mental, emotional and spiritual health. Much like physical therapy, biofeedback training requires active participation on the part of patients and often regular practice between training sessions. Clinical biofeedback may be used to manage disease symptoms as well as to improve overall health and wellness through stress management training. Research has shown that biofeedback interventions are efficacious in treating a variety of medical conditions, and many Americans are turning to biofeedback and other less traditional therapies for their (Dana et al., 2010).

HYPOTHESES: null hypothesis

RESEARCH QUESTION: Does biofeedback give effect on shoulder muscles strength post mastectomy?

27 patient per group to G power 90% a Inclusion Criteria:

The subject selection will be according to the following criteria:

* Female patients with age range between 40-60 will participate in the study.
* All patients with their informed consent.
* All patients with unilateral mastectomy
* All patients have shoulder muscle weakness within 2 to 4 months post mastectomy
* All patients with chemo or radio therapy 1.2.b Exclusion Criteria:

The potential participants will be excluded if they meet one of the following criteria:

* metastasis
* Psychological Disorder
* Lymphedema
* Neurological or musculoskeletal disorders

Eligibility Criteria:
Inclusion Criteria:

* The subject selection will be according to the following criteria:
* Female patients with age range between 40-60 will participate in the study.
* All patients with their informed consent.
* All patients with unilateral mastectomy
* All patients have shoulder muscle weakness within 2 to 4 months post mastectomy
* All patients with chemo or radio therapy

Exclusion Criteria:

* The potential participants will be excluded if they meet one of the following criteria:
* metastasis
* Psychological Disorder
* Lymphedema
* Neurological or musculoskeletal disorders
A Study of Tocilizumab (RoActemra/Actemra) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous Tumor Necrosis Factor (TNF) Antagonist Therapy

This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of tocilizumab (RoActemra/Actemra) in patients with ankylosing spondylitis (AS) who had an inadequate response to previous tumor necrosis factor (TNF) antagonist therapy. Patients were randomized to receive tocilizumab at a dose of either 8 mg/kg or 4 mg/kg intravenously (iv) or placebo every 4 weeks for 24 weeks. The double-blind treatment period was followed by open-label treatment with tocilizumab 8 mg/kg iv every 4 weeks until Week 104 for all patients.

This study and all further clinical development of tocilizumab AS was halted after a review of 12-week data from Study NA22823, a randomized double-blind, placebo-controlled study in TNF antagonist naïve AS patients, failed to demonstrate efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years of age.
* Ankylosing spondylitis as defined by the modified New York criteria for ≥ 3 months prior to baseline.
* Active disease at screening and baseline (Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] ≥ 4.0, spinal pain visual analog scale \[VAS\] ≥ 40).
* Inadequate response or intolerant to 1 or more previous non-steroidal anti-inflammatory drugs (NSAIDs).
* Inadequate response to treatment with etanercept, infliximab, adalimumab, or golimumab because of inadequate efficacy.
* Tumor necrosis factor (TNF) antagonist therapy must have been discontinued at least 8 weeks prior to baseline (etanercept 4 weeks).
* Traditional disease-modifying anti-rheumatic drugs (DMARDs) must be withdrawn for at least 4 weeks prior to baseline (methotrexate, sulfasalazine, and hydroxychloroquine or chloroquine may be allowed if at stable dose for at least 4 weeks prior to baseline).
* Oral corticosteroids (≥ 10 mg/day prednisone or equivalent) and NSAIDs/cyclooxygenase-2 \[COX-2\] inhibitors must be at stable dose for at least 4 weeks prior to baseline.

Exclusion Criteria:

* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after randomization.
* Total ankylosis of spine (as determined by investigator).
* Inflammatory rheumatic disease other than ankylosing spondylitis.
* Active, acute uveitis at baseline.
* Previous treatment with tocilizumab.
* Intra-articular or tendon injections or parenteral corticosteroids within 4 weeks prior to screening.
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
* Active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infection.
* History of or currently active primary or secondary immunodeficiency.
* Body weight \> 150 kg.
Study of Association Between Digital Osteoarthritis and Lower Limb Osteoarthritis

Among the risk factors for lower limb osteoarthritis, if obesity is probably the most studied, digital osteoarthritis received increasing interest in recent years. Recent publications have highlighted a link between obesity and digital osteoarthritis, but also a very probable link between digital osteoarthritis and structural progression of knee osteoarthritis. Few data including hip exist and need to be confirmed on larger scale studies. We have with "Khoala" a national multiregional cohort of symptomatic gonarthrosis and coxarthrosis representative of the general population (which is rarely the case in the literature) including X ray, clinical and biological follow-up (hips and / or knees).


Eligibility Criteria:
Inclusion Criteria:

* men or women aged 40 to 75 years
* with symptomatic osteoarthritis of the hip and / or knee (femoro-tibial), unilateral or bilateral
* with a confirmed diagnosis (criteria of the American College of Rheumatology :ACR) and Kellgren and Lawrence radiological stage ≥ 2.

Exclusion Criteria:

* painful hip or knee prosthesis
* osteotomy in the past
COgnitive Dynamics in Early Childhood

The goal of this accelerated longitudinal observational cohort study is to advance our understanding of cognitive variability in children aged 7 to 10 at first measurement. The CODEC study aims to integrate experience sampling methods, longitudinal designs, deep phenotyping cohorts, and state-of-the-art statistical methodologies to investigate three core questions:

1. How does cognitive variability differ between individuals?
2. What are the neural, psychological, and environmental mechanisms that underlie cognitive variability?
3. What are the long-term consequences and outcomes associated with differences in cognitive variability?


Eligibility Criteria:
Inclusion Criteria:

* In order to be eligible to participate in the behavioural arm of this study, a subject must meet all of the following criteria:

  * Between the ages of 7 and 10 years at the moment of the first assessment. In order to be eligible to participate in the imaging arm of this study, a subject must meet all of the following criteria:
  * Between the ages of 8 and 10 years at the moment of the first assessment.

Exclusion Criteria:

* A potential subject will be excluded from participation in the study if the participant indicates not understanding the instructions of the behavioural tasks due to a language barrier. In the imaging arm of the study, a potential subject who meets any of the following criteria will further be excluded from participation in the imaging arm of the study:

  * History of neurological or psychiatric illness.
  * History of using psychotropic medications.
  * Contraindications for MRI.
  * Metal parts that cannot be removed, are present in or on upper body, e.g. plates, screws, aneurysm clips, metal splinters, piercings or medical plasters. (exception: dental fillings, crowns, a metal wire behind the teeth, tattoos and contraceptive coils).
  * Body containing metal fragments, in particular in the eye, e.g., caused by injuries when working with metal.
  * History of brain surgery.
  * Active implant(s) (e.g. pacemaker, neurostimulator, insulin pump, ossicle prosthesis)
  * Using a medical plaster that cannot or may not be taken off (e.g. nicotine plaster)
ED-LEAD: Emergency Departments Leading the Transformation of Alzheimer's and Dementia Care

The purpose of this study is to improve the care of persons living with dementia (PLWD) and their informal care partners by addressing emergency and post-emergency care through different combinations of three PLWD-care partner dyad focused interventions. The primary aims are to use coaching to help connect PLWD and their care partners with community support and services to improve transitional care, quality of care, care satisfaction and reduce future ED visits and hospitalizations.


Eligibility Criteria:
Inclusion Criteria:

* patients age 66 and older
* have two or more ICD-10 visit diagnoses (one of which must be ambulatory) for Alzheimer's Disease or Alzheimer's Disease Related Dementias (AD/ADRD)
* care partners age 18 and older

Exclusion Criteria:

* patients who are under 66 years old
Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of BIBB 1464 MS in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food

Safety, pharmacodynamics and pharmacokinetics of 0.25, 0.75, 2.0, 6.0, and 10 mg BIBB 1464 p.o once daily in a rising dose group-comparison (placebo controlled, double blind, randomized per dose level).

Relative Bioavailability of 0.75 mg or 2 mg or 6 mg ( tablet vs. solution, intraindividual comparison), preliminary assessment of food effects (interindividual comparison)

Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase).

MS (Tablet) in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food of the Dose of 0.75 mg or 2 mg or 6 mg (Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase).


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects as determined by results of screening
* Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
* Age \> 18 and \< 55 years
* Broca \> - 20% and \< + 20%

Exclusion Criteria:

* Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance.
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal (including thyroid) disorder
* Surgery of the gastro-intestinal tract (except appendectomy)
* Disease of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) (\<= 1 month prior to administration or during the trial)
* Use of any drugs which might influence the result of the trial (\<= 10 days prior to administration or during the trial)
* Participation in another trial with an investigational drug (\<= 2 month prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars or \>3 pipes/day)
* Inability to refrain from smoking during the period of the study
* Known alcohol (\>60 g/day) or drug abuse
* Blood donation (\<=1 month prior to administration)
* Excessive physical activities (\<5 days prior to administration)
* Any laboratory value outside the normal range of clinical relevance
* History of hemorrhagic diatheses
* History of gastro-intestinal ulcer, perforation or bleeding
* History of bronchial asthma
Clinical and Genetic Profile of Pediatric Patients With Cystic Fibrosis in Sohag.

Cystic fibrosis (CF) is an autosomal recessive genetic disorder caused by mutations in the gene encoding CF transmembrane conductance regulator (CFTR), which is located at 7q31.2 and encodes 1480 amino acids. CFTR protein is responsible for regulating the transport of electrolytes and chloride across epithelial and mucus-producing cell membranes.

The discovery of the CFTR gene in the late 1980s triggered a surge of basic research that enhanced understanding of the pathophysiology and the genotype-phenotype relationships of this clinically variable disease of cystic fibrosis. More than 2000 variants of CFTR gene have been reported, and they are grouped to six classes depending on the pathophysiology of the CFTR protein ,The most common genetic defect reported in CF is the delta F508 mutation, Moreover, the degree of CF severity depends on the type of mutation, which typically affects the function and quantity of CFTR channels. When the CFTR protein is mutated, chloride ions accumulate in mucus-producing cells, resulting in a thick, sticky mucus that obstructs various pathways and hinders pulmonary, digestive, exocrine and male reproductive functions. Furthermore, mucus buildup increases a patient's susceptibility to airway obstruction, bacterial lung infection, pancreatic insufficiency, malabsorption and infertility. CF is characterized by significant clinical heterogeneity.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents aged 2 days - 18 year.
* patients clinically suspected or diagnosed with cystic fibrosis
* patients diagnosed with cystic fibrosis and attending or referred to the Pediatric pulmonology clinic at Sohag University Hospital.

Exclusion Criteria:

* Patient with cystic fibrosis like symptoms with another confirmed diagnosis ex. primary ciliary dyskinesia
A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia

The purpose of the study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

This is a multi-center, randomized, double-blind, placebo-controlled study in 617 participants. Participants will be randomized to receive olezarsen or placebo in a 53-week treatment period. The length of participation in the study will be approximately 78 weeks, which includes an up to 12-week screening period, a 53-week treatment period, and a 13-week post-treatment evaluation period or transition to open-label extension (OLE) study with up to 1-year treatment.

Eligibility Criteria:
Key Inclusion Criteria:

* Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification
* Patients must be on lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines. Lipid-lowering medications should be optimized and stabilized for at least 4 weeks prior to Screening to minimize changes in these medications during the study.

Key Exclusion Criteria:

* Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening
* Alanine aminotransferase or aspartate aminotransferase \> 3.0 × upper limit of normal
* Total bilirubin \> upper limit of normal unless due to Gilbert's syndrome
* Estimated GFR \< 30 mL/min/1.73 m\^2
Triclosan Toothpaste and Third Molar Surgery

Triclosan containing dentifrices are effective in the prevention of inflammatory complications following third molar surgery through reducing preoperative oral bacteria load.

This study may provide evidence on the effect of triclosan containing dentifrice on oral bacteria and oral inflammation prior to third molar surgery, and on the incidence of inflammatory complications after the surgery. If proven effective, dentifrice containing triclosan may be recommended prior to tooth extractions and replace antibiotics and other antimicrobial products as a prophylactic procedure before oral surgery procedures.

Eligibility Criteria:
Inclusion Criteria:

* must include at least one mandibular third molar with partial or full bony impaction
* no sign of active pericoronal (around the crown) infections
* must have not taken antibiotics for any reason in the past 30 days
* must be healthy and between 18 and 35 years of age
* must be able to read and sign an informed consent

Exclusion Criteria:

* Subjects with systemic diseases and pregnant or lactating women
* Subjects with advanced periodontal diseases or having two or more untreated caries lesions
* Subjects who cannot read and sign an informed consent
* Subjects with signs of pericoronal infections
Time to Eat Study - Pilot

The goals of this pilot study is to evaluate the safety and feasibility of time restricted feeding in an older adult population.

For this 4-week pilot study, the study team will recruit 10 overweight, older adults who are at risk for, or have, mobility impairment, as measured by slow gait speed and self-reported mobility difficulty and self-reported sedentary lifestyle. All participants will receive the time restricted feeding intervention, which will consist of limiting the time in which food is consumed to 8 hours per day and fasting for 16 hours per day. The study will also assess the variance of inflammatory markers, walking speed, physical and cognitive function, grip strength, body measurements, perceived fatigability, health related quality of life and activity level. This allows the refinement of the design, recruitment yields, target population, adherence, retention, and tolerability of a larger scale study.

Eligibility Criteria:
Inclusion Criteria:

* Consent to participate in the study
* Men and women ≥ 65 years old
* Self-reported difficulty walking ¼ mile or climbing a flight of stairs
* Self-reported sedentariness (\<30 minutes structured exercise per week)
* Walking speed \<1 m/sec on the 4 m walk test
* Able to walk unassisted (cane allowed)
* Have a body mass index between 25 - 40 kg/m2 (inclusive)

Exclusion Criteria:

* Current dietary habits

  * Fasting \>12 hours per day
  * Actively trying to lose weight by participating in formal weight loss program or significantly restricting calorie intake
  * Weight loss \> 5 lbs in the past month
* Medical history or conditions

  * Resting heart rate of \>120 beats per minute, systolic blood pressure \> 180 mmHg or diastolic blood pressure of \> 100 mmHg
  * Unstable angina, heart attack or stroke in the past 3 months
  * Continuous use of supplemental oxygen to manage a chronic pulmonary condition or heart failure
  * Rheumatoid arthritis, Parkinson's disease or currently on dialysis
  * Active treatment for cancer in the past year
  * Insulin dependent diabetes mellitus
* Taking medications that preclude fasting for 16 hours (e.g. must be taken with food at least 12 hours apart)
* Any condition that in the opinion of the investigator would impair ability to participate in the trial