cyrilzakka/clinical-trials huggingface dataset:
Biologics in Chronic Rhinosinusitis With Nasal Polyposis

The prevalence of Chronic Sinusitis with Nasal Polyps (CRSwNP) in the United States is estimated at roughly 4%, which equates to over 13 million Americans. Until recently, the only medical treatment options available for patients with CRSwNP were corticosteroids, with surgery reserved for medical failure. The development of biologic medications over the last 5 years has revolutionized the treatment of CRSwNP. Three biologic medications have been FDA approved and available for the treatment of CRSwNP: dupilumab, omalizumab, and mepolizumab. However, data from the clinical trials for these drugs do not show universal improvement across all patients with CRSwNP. In fact, there is a wide range of outcomes for patients in these trials. The result is that clinicians have no way of knowing which specific biologic would be the best option for any given patient, nor do they know whether biomarkers can be used to predict response to biologics. It is hoped that findings from this study will inform whether any one biologic has superior outcomes to another and whether clinicians can identify patients at baseline who are most likely to improve on biologic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Confirmed diagnosis of chronic rhinosinusitis with nasal polyposis using ICAR-21 (International Consensus Statement 20215) criteria
* Bilateral nasal polyposis visible on sinonasal endoscopy
* Nasal polyp score \> 5
* Baseline SNOT-22 total score \> 30
* Patient elects biologic therapy for the management of CRSwNP
* Capable of receiving all 3 biologic therapy medications.
* Treatment with intranasal mometasone ≥200 μg. once daily (or equivalent of another intranasal corticosteroid) for 1-month prior to baseline visit.

Exclusion Criteria:

* Inability or unwillingness of a participant to give written informed consent or comply with study protocol
* Endoscopic sinus surgery within 6-months preceding enrollment / randomization.
* Oral corticosteroid use within 30-days preceding enrollment / randomization.
* Serum IgE level outside the dosing range for omalizumab (i.e., \<30 IU/ml. or a weight-based dose with insufficient data to determine dose as per FDA dosing chart)
* Comorbid atopic dermatitis, urticaria, or any other condition that would require a specific biologic per the standard of care.
* Currently pregnant or plan to become pregnant within the 6 months after enrollment / randomization.
* Any previous treatment with any of the 3 biologic medications.
* Comorbid cystic fibrosis, CVID, or ciliary dyskinesia.
* Comorbid systemic inflammatory disorders (e.g., GPA, EGPA, Sarcoidosis, SLE)
* Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks for participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.
Instrument Assisted Soft Tissue Mobilization Effect on Blood Flow

This study is designed to evaluate the short term change in blood flow in the superficial human tissue layers after the application of 3 min Graston instrumented assisted soft tissue mobilization on the plantar aspect of the foot and the trapezius muscle.

Instrument assisted soft tissue mobilization (IASTM) is a commonly used physical therapy intervention. Graston ® technique is a form of IASTM that requires completion of a certification course and utilizes specific stainless-steel tools. IASTM has been found to improve range of motion, pain and patient reported function in pathological individuals. One method by which these improvements are thought to occur is by increasing blood flow. Increased blood flow brings nutrients and oxygen to the area and is thought to contribute to tissue remodeling. There is very limited research investigating blood flow changes following IASTM. In order to measure blood flow changes following IASTM, doppler ultrasound may be used. There are no studies to our knowledge quantifying changes in blood flow following IASTM using ultrasound. Power doppler approximates perfusion by detecting a frequency shift from movement of red blood cells and color is then encoded proportionally to the number of red blood cells. Power doppler imaging quantification (PDIQ) is a feature of musculoskeletal ultrasound (MSK) that compares the number of color pixels and the intensity of color within these pixels to grey scale pixels within a given image. The aim of this study is to determine if there is an increase in blood flow in the trapezius, plantar fascia and medial arch of the foot measured following IASTM. Blood flow was measured by using PDIQ ratio in the doppler setting of MSK ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* A-symptomatic individuals over the age of 18

Exclusion Criteria:

* Anyone under 18 and anyone with any conditions contraindicated for IASTM including compromised tissue integrity, deep vein thrombosis (DVT), area of infection in the treatment area, or acute fracture.
Brief CBT for the Treatment of Depression During Inpatient Hospitalization

Moderately to severely depressed subjects will be randomized to the "Control Group," who will receive care as usual, or the "CBT Group," who will receive care as usual in addition to the manualized course of Cognitive Behavioral Therapy (CBT).

Participants assigned to the CBT condition will receive the usual standard of care during an inpatient psychiatric hospitalization. This includes but is not limited to medication management, group therapy, and individual therapy. If a patient is randomly assigned to the enhanced CBT group, manualized CBT, including a sequence of sessions that builds upon prior sessions and planned exercises, including worksheets and journal entries.The training M.D., who is a treating physician on HCC-10, will also intermittently and randomly observe the CBT sessions to ensure the manual properly is being followed. Although the control condition may contain elements of CBT as per the clinician completing the therapy, it is not manualized, does not include specific exercises to be completed between sessions, and is not a course that builds upon skills from the previous day, as in the CBT condition. Participants assigned to the control condition will receive the usual standard of care during an inpatient psychiatric hospitalization. This includes but is not limited to medication management, group therapy, and individual therapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with depression according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria on initial assessment on the unit.
* Demonstrates at least moderate degree of depressive symptoms on MADRS, HAM-D, and CGI-S.
* Provides written informed consent.

Exclusion Criteria:

* A mental illness other than depression that is the primary cause of treatment, as determined by the Principal Investigator.
* A cognitive or neurologic disorder that inhibits ability to engage in CBT.
The Effect of Dexamethasone on Pain After Total Knee Replacement Surgery

The purpose of this study is to examine, if a single-dose of dexamethasone given during the operation, alleviates pain after knee replacement surgery.

The purpose of this study is to examine, if a single-dose of dexamethasone given during the operation, alleviates pain after knee replacement surgery. This is also a dose-finding study comparing two doses of dexamethasone.

Total knee arthroplasty causes considerable pain. Multimodal analgesia and peripheral nerve blocks are used for treatment of pain. Some studies suggest that glucocorticoids alleviate postoperative pain. The optimal dose of dexamethasone in treatment of postoperative pain is not known. Studies on this subject in patients with total knee replacement are sparse. Potential side-effects of dexamethasone (hyperglycemia, wound infection) need to be studied.

Patients coming for primary knee replacement surgery are enrolled. The patients in each study group receive multimodal therapy for postoperative pain: etoricoxib, paracetamol, gabapentin and oxycodone. A single dose of intravenous dexamethasone (0,15 mg/kg or 0,25 mg/kg) or a placebo (saline) is administered to the patient during the operation. The effect of dexamethasone on postoperative pain is observed: main outcome is dynamic pain at 24 h postoperatively. The extent of inflammatory reaction is measured (CRP). Serial blood glucose measurements are done.

Eligibility Criteria:
Inclusion Criteria:

* primary total knee replacement surgery
* ASA (american society of anesthesiologists) class 1-3

Exclusion Criteria:

* severe coronary artery disease, heart failure, kidney failure
* insulin-dependent DM (diabetes mellitus), poorly controlled type II DM
* gastric/duodenal ulcer
* allergy/contra-indication for any drug used in the study
* corticosteroid use during last 3 months
* preoperative use of opioid drugs (excl. codeine, tramadol)
* neuropathy/sensory impairment of lower limbs
* lack of co-operation, e.g. inability to use a PCA (patient controlled analgesia)-device
The Effect of Local Injectet GH on the Collagen Synthesis in the Ligamentum Patella

Tendon and ligament injuries are a frequent problem among athletes but also in the general population. The healing process is a prolonged process, and complete recovery of tissue strength is nearly never reached. The purpose of this study is to examine the effect of local injection of human Growth Hormone on tendon collagen synthesis.

Tendon and ligament injuries are a frequent problem among athletes but also in the general population. The healing process is a prolonged process, and complete recovery of tissue strength is nearly never reached. The purpose of this study is to examine the effect of local injection of human Growth Hormone on tendon collagen synthesis.

in order to investigate the collagen synthesis potential and the influence of growth hormone, 12 elderly males age \> 50 year, is enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5 - 25.0

Exclusion Criteria:

* earlier knee injury
Test the Outdoor Usage for Sunscreen Products in Female Adults

To assess the safety of a sunscreen product when used outdoor.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be healthy, fair skinned females between the ages of 18 to 65 years with no medical conditions of the skin.
* Subjects must have Fitzpatrick Skin Types I, II, III, or IV.
* Subjects must agree to restrict their sun exposure activities for at least five days.
* Subjects must be willing and physically able to spend approximately 3 continous hours in the sun.

Exclusion Criteria:

* Subjects must not have actinic keratoses, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions as determined by the dermatological medical history.
* Subjects must not have visible erythema, blistering, or peeling that would indicate recent sunburn.
* Subjects must not have significantly tanned skin.
* Subjects must not have received any phototoxic agent or any medication to which they have a known sensitivity or allergy.
Socioeconomic Inequalities Exacerbated by Mitigation Measures to COVID-19 and Differences in Prematurity Prevalence

Objective: to assess the perinatal results in Uruguay during the semester of successful control of the COVID 19 pandemic to evaluate the impact of the crises in the public and private sub sectors of the Health System.

Methodology: An analytical observational study was carried out, comparing the semesters from March 15 to September 30, 2019 (year prior to the COVID 19 pandemic) with the same period 2020 (year of the COVID 19 pandemic), in the 2 sub sectors of public and private health care.

An analytical observational study was carried out, comparing the semesters from March 15 to September 30, 2019 with the same period 2020, in the 2 sub sectors of public health care of the private sub sector throughout the country, taking all births in that period of time.

The semester selected is based on the fact that the first months of the pandemic were the ones with the greatest mitigation measures with drastic socio-economic consequences, but it was also a period of almost zero COVID infection in pregnancy, this being an opportune moment not to have as confounding factor to the maternal and fetal biological complications of this infection.

The situation will be analyzed in the 2 sub sectors of public health care, made up of the State Health Services Administration (ASSE), police health and military health, and the UDELAR Clinic Hospital, on the one hand, and the private sub-sector. made up of the Institutions of Collectivized Medical Assistance (IAMC) of Montevideo and the Interior (FEPREMI) and the private health care insurance.

The primary variable to be analyzed in both periods and in both subsectors of the national integrated system health was the incidence of preterm births (less than 37 weeks gestational age), low birth weight (newborns with a birth weight less than 2,500 grams) and intrauterine growth restriction (marked by doctor attending the birth, as a clinical diagnosis of the current pregnancy)

For the analysis of the national data, of the study periods, the database was requested from the Ministry of Public Health. This database is provided to researchers anonymously

Eligibility Criteria:
Inclusion Criteria:

* all live birth

Exclusion Criteria:

* stillbirth
A Double-Blind Pharmacokinetic Interaction Study Evaluating the Effect of a Single IV Infusion of GGF2 or Placebo on Midazolam Pharmacokinetics in Patients With Heart Failure

The study will examine midazolam pharmacokinetics following single dose administration of 3 planned dose levels of GGF2 .

This drug-drug interaction (DDI) study evaluates the potential effect of intravenously administered GGF2 on the elimination kinetics of midazolam.

Eligibility Criteria:
Inclusion Criteria:

* If female, must be at least 2 years post-menopausal or have bilateral oophorectomy, hysterectomy or documented sterility
* If male, must have documented sterility (by verbal report or previous vasectomy), or if non-sterile, must agree to use barrier contraception for the entire duration of the trial and until 3 months after the last dose of investigational product. Must also agree not to donate sperm during the study and up to 3 months after the last dose of investigational product
* Stable coronary disease without unstable angina or acute coronary syndrome in the last 6 months
* All cardiac medications, specifically beta-blockers, renin-angiotensin system inhibitors, aldosterone antagonists, hydralazine and nitrates are at a stable dose (at least 4 weeks) prior to Day 1

Exclusion Criteria:

* Any previous exposure to GGF2 or other neuregulins
* Initiation or change of a prescription medication within the 2 weeks prior to Day 1, and/or concomitant medication regimen is expected to change during the course of the study
* Known allergic reaction to midazolam, or any of the components of midazolam syrup (including cherry flavoring), or components of GGF2 diluent
* Known specific hepatic disease; total bilirubin \>2 mg/dL, AST \> 100 IU
* History of hepatic impairment (hepatitis B and C)
* Type I Diabetes
* Documented stroke or transient ischemic attack (TIA) within 2 months of study enrollment
Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil

In this study, subjects who are attending the dermatology clinic and who have already been prescribed topical 5-fluorouracial for the treatment of actinic keratoses as part of their standard of care will be recruited. The purpose of the study is to assess patient satisfaction when engaging in follow up treatment of actinic keratosis via the HIPAA-compliant teledermatology platform called Klara. Additionally, the goal is to assess the difference in total duration of treatment between treatment and control group. A total of 50 subjects will be enrolled and will be randomly assigned into the treatment group (teledermatology group; n=25) or control group (telephone only group; n=25).

Objectives

To assess patient satisfaction when engaging in follow up treatment of actinic keratoses: Follow up of subjects with actinic keratoses (AK) who have been prescribed topical 5-fluorouracil (5-FU) therapy as part of their standard of care.

To assess the difference in total dose of exposure to 5-FU between treatment and control group.

Background

Teledermatology is a growing field within dermatology that has started to adapt the use of mobile phone technology (1). The growth of teledermatology has allowed greater access to care in both the inpatient and outpatient setting (1, 2), as well as in educational services (3). The aim of this study is to investigate how mobile phone photographic teledermatology can be adapted for use in the dermatology clinic to continually engage with the patient. More specifically, the researchers seek to understand how mobile phone technology can be used in the evaluation of subjects on topical 5-FU therapy for their actinic keratoses.

Diffuse actinic damage is typically treated with field therapy (4) that involves the use of topical 5-FU. Patients are advised to apply the cream twice daily for 2-4 weeks (5). However, many patients note misunderstanding with these instructions (6). Typical follow up has included telephone based grading and in person follow up (5). However, a return visit to the clinic can be both burdensome to the patient and fill up the clinic with follow up appointments instead of allowing the appointment slot to go to examination of a new patient, thereby reducing access to care for other patients. Telephone conversations are not based on a physical exam and thus do not allow for objective evaluation of the treatment area. For this reason, the researchers seek to use mobile phone photography to evaluate patients with actinic keratoses on topical 5-FU treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years of age or older
* Subjects who have already been prescribed topical 5-fluorouracil for treatment of scalp, facial, arm, or hand actinic keratoses but have not initiated treatment yet

Exclusion Criteria:

* Adults unable to consent
* Non English speaking or illiterate
* Subjects with known allergy to 5-fluorouracil
* Subjects who do not have access to a smartphone capable of engaging with the online teledermatology platform
* Pregnant women
* Prisoners
The Faroese Knee Cohort: Etiology and Long-term Implications of Trochlear Dysplasia and Patellar Dislocations.

The investigators intend to establish a national cohort including all persons in the ages from 15-20 years old with patellar instability (PI) or a prior knee injury (ACL-ruptur or meniscus damage) . The cohort will be nicknamed "The Faroese Knee Cohort".

The overall aim is to investigate two groups.

1. The patella instability group, in which we intend to investigate the following.

   * Prevalence of patellar dislocation and trochlear dysplasia in the Faroe Islands.
   * Risk factors for patellar dislocations-
   * Heredity of trochlear dysplasia.
   * If there is a specific gene responsible for the development of trochlear dysplasia.
   * The development of retropatellar artrhosis, its onset and its impact on quality of life and function,
2. Knee injury group (ACL-ruptur or meniscus injury)

   * The prevalence of ACL-rupture and/or meniscus injury in this specific group in the Faroe Islands.
   * The impact on quality of life and function.

The Faroese Knee Cohort aims to consist of all persons in the Faroe Island between 15-20 years old with patellar instability\* (PI) or a knee injury.

Special focus will be on PI, Patella dislocation (PD) and Trochlear Dysplasia (TD), a condition where the femoral trochlea has a dysplastic shape and lacks the lateral support of the patella. The diagnosis will be set by MRI of the knees and is in this study defined as the presence of one of the following: Crossing sign on a true lateral x-ray, lateral trochlear inclination angle \< 11 degrees or a trochlear depth \< 3 mm.

The hypothesis is that abnormal values in the following measures will be associated with increased risk of patellar dislocation and worse patient reported outcome: Caton-Deschamps index, Lateral Trochlear Inclination, Trochlear Facet Asymmetry, Trochlear Depth, Tuberostias Tibia - Trochlear Groove distance, Patello-trochlear index and Tuberositas Tibia - Posterior Cruciate Ligament distance.

Furthermore, we expect pivoting sports to be a behavioral risk factor.

The primary endpoint is measured by the number of patellar dislocations or near-dislocation the patient experiences (daily, weekly, monthly, yearly).

The secondary endpoint is the patient reported outcome measures.

\*Definition: Patellar instability (PI) is the overall term encompassing both 1) recurrent patella dislocations and 2) recurrent episodes of a clear sensation of the kneecap riding on the outer border/aspect of the knee before popping back in track. The episodes must be a severe complaint for the patient. PI usually follows after a first time patellar dislocation.

Eligibility Criteria:
Inclusion Criteria:

* Age between 15-20 years at the start of patient enrolment.
* The feeling of patellar instability, or patellar dislocation/near-dislocation.
* The person has to be from the Faroe Islands.
* All persons under the age of 18 must get written consent by their parents

Exclusion Criteria:

* Terminal illness
* Mental disabilities and illness, meaning that the patient cannot independently answer the PROM´s and cooperate to the clinical investigation.