cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures

Evaluated whether HA coated dynamic hip screws can improve the surgical results in trochanteric femoral fractures

Randomised study to determine the effect of HA coating on the stability of lag screws used to reduce femoral neck fractures. Stability of the screw will be determined by RSA measurements. The effect of the HA coating on bone remodeling will be determined by DEXA measurements

Eligibility Criteria:
Inclusion Criteria:

* Patients with trochanteric femoral fractures

Exclusion Criteria:
Effects of a Basketball-Specific Warm-Up, "Basket Up," on the Sports Performance of Young Basketball Players

This study evaluates the effects of a specific 9-week basketball warm-up program, "BasketUp," on athletic performance, comparing it to the FIFA 11+ program. Male and female basketball players are randomly assigned to either the BasketUp or FIFA 11+ warm-up groups, performing these routines before practice three times a week for 9 weeks. Key performance metrics-sprinting speed, countermovement jump (CMJ), and agility-are measured at the start and end of the study.

Current evidence is limited on the effectiveness of basketball-specific warm-up programs. This study evaluates the impact of a 9-week basketball-specific warm-up, "BasketUp," on sports performance, comparing it with the FIFA 11+ program. Male and female basketball athletes, are randomly assigned to either the BasketUp program or FIFA 11+. Both warm-ups are performed three times per week before basketball practice over the 9-week period. Performance measures-including sprinting, countermovement jump (CMJ), and agility-are assessed at the beginning and end of the intervention. A two-way mixed ANOVA analyzes the effect of time (baseline vs. 9 weeks) and group on these outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Have competed in at least one national basketball event within the past two years
* Consistently attend basketball practices throughout the season

Exclusion Criteria:

* Any current injury or condition restricting athletic activity
* A history of injury necessitating non-surgical treatment within the past 3 months
* A history of injury requiring surgery within the last 9 months
Omnaris Versus Levocetirizine Phase 4 Study

This i a comparison of the efficacy ciclesonide nasal spray and levocetirizine, alone and in combination.

randomized, open-label, three arm, parallel group, multi-center study

Eligibility Criteria:
Inclusion Criteria:

* Allergic rhinitis patients aged ≥ 18 years (with a history of AR of 1 years or longer)
* Moderate to severe patient according to ARIA guideline
* To have a demonstrated positive skin prick test or other serologic tests to at least 1 allergen.
* Subjects who complete the subject diary(S) at least 70%.

Exclusion Criteria:

* Nasal pathology, including nasal polyps, clinically relevant respiratory tract malformations, recent nasal biopsy (within 60 days), nasal trauma, nasal surgery, atrophic rhinitis, rhinitis medicamentosa (within 60 days), asthma requiring corticosteroid treatment
* Hypersensitivity to corticosteroid and/or hydroxyzine
* Hypersensitivity to galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption
* A history of respiratory tract infection or disorder within 2 weeks of the screening visit or had a respiratory tract infection during baseline
* Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of β-agonists
* Treated with systemic corticosteroids (within 8 weeks of study initiation) or topical corticosteroids (\> 1% hydrocortisone, within 4 weeks of study initiation) or antibiotics (within 2 weeks of first visit)
Mind-Body Training for Hand Rehabilitation

The objectives of this pilot study are to: (1) evaluate acute effects of biofeedback and mindfulness training on pain, anxiety, and stress during a hand therapy visit and (2) gain understanding of patient perceptions, preferences, and experiences with mind-body interventions.

Each year more than $5.7 billion is spent on outpatient therapy, which is projected to grow 6% annually over the next decade. Subsequently, healthcare reform is mandating more efficient, high-quality care to control spending. Thus, the long-term goal of this work is to develop an integrative health intervention for hand therapy that improves efficiency, enhances outcomes and reduce costs. Biofeedback and mindfulness training are two mind-body interventions that can increase patient engagement and self-efficacy. No research has investigated the integration of these mind-body interventions into treatment for hand therapy patients. This pilot research will explore the acute effects of these techniques in hand therapy patients. This study utilizes a repeated-measures crossover design with 20 participants to explore the effects of mindfulness training and the dynamic biofeedback with sonographic imaging on acute pain, anxiety, and stress. Additionally, the study will evaluate hand therapy patient preferences and perceptions of mind-body techniques. This patient-centered, clinical translational work will provide valuable feasibility data regarding the direct, acute effects of mind-body interventions to inform the development and further study of an integrative hand rehabilitation approach. This responds to a need for best practices for maximizing the mind-body connection and the call to investigate innovative uses of mindfulness to enhance patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Referral to USC Keck Hospital Hand Clinic
* Upper extremity pathology resulting in decreased hand use
* Pain with activity greater than 4 out of 10
* Scheduled to attend at least 2 therapy sessions per week
* Speak and read English
* Able to independently read and respond to questionnaires

Exclusion Criteria:

* Cast or open wounds in the distal upper extremity
* Bilateral upper extremity pathology involvement
* Significant visual or hearing deficit
Behavioral Economic Incentives and Cancer Health Risk Assessment

This is an RCT among UPHS employees between ages 50-64 comparing no incentive and a loss-framed incentive for completing cancer health risk assessment. Those eligible will receive the phone number for direct colonoscopy scheduling, with the incentive arm receiving an additional unconditional incentive. The primary outcome is completion of screening colonoscopy. Secondary outcomes include scheduling of colonoscopy and completion of risk assessment.

Colorectal cancer (CRC) is the second leading cause of cancer death in the United States. Despite effective screening and treatment strategies, screening rates remain at 59-65%. UPHS employees have similarly limited rates of CRC screening despite having awareness, access, and insurance coverage. There is a need to identify those who are not up-to-date on screening and eligible for outreach in this population. Financial incentives informed by behavioral economic principles could be used to encourage self-report about screening status and completion of CRC screening. This research utilizes a digital health platform, Way to Health, to evaluate the feasibility of a cancer health risk assessment. This is a single-center RCT among UPHS employees between ages 50-64 that will randomize eligible participants into one of two study arms: (1) no incentive to complete cancer health risk assessment (no incentive) or (2) loss-framed incentive to complete cancer health risk assessment (incentive). Those that are eligible for screening will receive a direct access phone number to schedule colonoscopy, with an additional unconditional incentive for those in incentive arm. The primary outcome is completion of screening colonoscopy, with secondary outcomes of colonoscopy scheduling and completion of risk assessment.

Eligibility Criteria:
Inclusion criteria:

* male and female UPHS employees between the ages 50-64
* those who live within 30 miles of the main endoscopy sites

Exclusion criteria:

-minimal exclusion criteria
"The Impact of Immunonutrition on Gut Microbiota-related Aspects in Colorectal Cancer and Gastric Cancer Patients"

Enteral immunomodulating nutrition modifies the gastrointestinal microbiota as well as improves the intestinal barrier integrity in patients with gastric and colorectal cancer in the perioperative period. As a consequence, it contributes to the reduction of the incidence of postoperative complications and diarrhea, which is a side effect of anti-cancer treatment often used preoperatively in this group of cancers.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 y.o.
* patients with gastric or colorectal cancer
* patients treated in Department of Surgical Oncology, Medical University of Gdańsk
* patients' agreement to take part in this study

Exclusion Criteria:

* age \<18 y.o.
* other types of cancer than gastric/colorectal cancer
* the presence of inflammatory bowel disease
* pregnancy
Proof of Concept Study for 1 Lead Patch Technology

This study is intended to assess the feasibility and usability of the 1 Lead Patch as a whole, on patients outside the hospital, in the out-patient setting.

This study is a two-phase evaluation of the use of a 1 Lead Patch System to monitor electrocardiogram (ECG) data and send the data to the LifeWatch Service Center, in the same manner as the existing ACT ambulatory telemetry system. It will be used in parallel with the standard 3 Lead ACT testing equipment used to monitor ECG outside the hospital. This study will not address safety or effectiveness and no comparator groups will be used. This study will not be treating any particular disease or condition and no randomization or blinding is required. Subjects will be selected in conjunction with their need for current outpatient telemetry monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female referred for 3 Lead ACT monitoring for between 7 and 14 days.
* Be recently prescribed a LifeWatch 3 Lead ACT monitor

Exclusion Criteria:

* under 21-years old
* pregnant or who may become become pregnant during the investigation period
* using internal or external defibrillators
* who are using pacemakers or implantable loop recorders
* showing skin damage on the chest, such as burns, irritation, infections, wounds, etc.
* meeting any contraindications for a patch biosensor
Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia

A study to evaluate the efficacy, safety, and pharmacokinetics of pilocarpine hydrochloride (HCl) ophthalmic solution (AGN-190584) when administered bilaterally, once daily for 30 days in participants with presbyopia.


Eligibility Criteria:
Inclusion Criteria:

- Subjective complaints of poor near vision that impact activities of daily living

Exclusion Criteria:

* History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery
* Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study
* Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes
* Corneal abnormalities (including keratoconus, corneal scar, Fuchs' endothelial dystrophy, guttata, or edema) in either eye that are likely to interfere with visual acuity
* Narrow iridocorneal angles (Shaffer grade ≤2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy
* Diagnosis of any type of glaucoma or ocular hypertension
Investigating Idiopathic Pulmonary Fibrosis in Greece

To gain further insight on the characteristics, management, disease progression and the outcomes of patients with IPF, as diagnosed and treated under real-world, clinical practice conditions in Greece. More specifically, this registry will be used to: Provide a comprehensive clinical picture of IPF, Track access to health care and cost of caring for IPF patients over time, Examine the implementation of treatment guidelines used on patients diagnosed with IPF, according to the existing diagnosis guidelines, Characterization of patients on different treatments. To provide information regarding survival and mortality causes, IPF exacerbations as well as IPF patient co-morbidities including myocardial infarction, CNS infarction, other arterial thromboembolic events, deep vein thrombosis, hemorrhage, gastrointestinal perforation and pulmonary hypertension. Data regarding IPF patient hospitalization will be collected and evaluated with regards to potential respiratory causes, and there will be documentation of treatment patterns and economic aspects. Patients will be followed up for 2 years and information regarding IPF treatment changes since the last visit will be collected.

Purpose: To gain further knowledge on the characteristics, management, progression and outcomes of patients with IPF as treated under real-world, clinical practice conditions in Greece

Study Design:

National, multi-center, observational disease registry based on new data from a significant sample size of IPF patients in Greece. Patients will be followed up for 2 years and information will be collected during this time period. This is a non-interventional study and primary data collected during study visits will be used

Eligibility Criteria:
Inclusion criteria:

* Newly diagnosed (less than 6 months) or patients previously diagnosed with IPF (more than 6 months from baseline visit), based upon the consensus statement jointly issued by ATS/ERS/JRS/ALAT in 2011 (see Annexes 6 and 7 for HRCT and histological criteria in Annex 6)

  * Exclusion of other known causes of ILD (e.g., domestic and occupational environmental exposures, connective tissue disease, and drug toxicity)
  * Assessment of IPF based on HRCT or combinations of HRCT and surgical lung biopsy, if available
* Age =40 years old at the time of inclusion
* Written informed consent for participation in the registry
* Patients that can be followed up further, during the scheduled study period

Exclusion criteria:

* Expected lung transplantation within the following 6 months
* Participation in clinical trials
PACAREG: a Multicenter Registry Trial in Pancreatic Ductal Adencarcinoma

PaCaReg is a multicenter registry trial aiming in the assessement of clinical, epidemiological and biological profiles in patients with pancreatic ductal adenocarcinoma


Eligibility Criteria:
Inclusion Criteria:

* Treatment naive histologically or cytologically proven pancreatic ductal adenocarcinoma (PDAC) or highly suspicious diagnosis (only pre-curative-intended resection)
* Age =\>18 years
* written informed consent

Exclusion Criteria:

* papillary cancer
* neuroendocrine pancreatic tumors
Study of Anti-r-HuEpo Associated Pure Red Cell Aplasia (PRCA) Treatment

Recombinant human erythropoietin (r-HuEpo) has been used to treat renal anemia and improve morbidity and mortality in chronic kidney disease. Subcutaneous use of r-HuEpo causes immunogenicity and develops anti-r-HuEpo associated pure red cell aplasia (PRCA). The treatment of anti-r-HuEpo associated pure red cell aplasia is controversial. The investigators aim to evaluate the treatment for anti-r-HuEpo associated pure red cell aplasia in this study.

Recombinant human erythropoietin was the first biotherapeutic medicinal product derived from recombinant DNA technology for the treatment of anemia in patients with chronic kidney disease (CKD). Although r-HuEpo raises hemoglobin levels in CKD and improves morbidity associated with anemia in CKD patients, the adverse immunological effect of r-HuEpo administered subcutaneously can result in anti-r-HuEpo associated PRCA. We aim to evaluate the effectiveness of two treatment protocol, cyclosporine combined with mycophenolate mofetil and cyclophosphamide combined with prednisolone for treatment of anti-r-HuEpo associated PRCA.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years old
* CKD patient with anti-r-huEpo associated PRCA

Exclusion Criteria:

* Pregnancy or lactating women
* Receiving immunosuppression
* Active infection
* Previous history of allergic reaction to cyclosporine, mycophenolate mofetil, cyclophosphamide, prednisolone
Immunity After COVID-19 Vaccination

The purpose of the research is to evaluate kinetic after vaccination to the COVID-19 coronavirus by measurements of specific and neutralizant antibodies for spike antigenic sequences .

This work will allow us to follow the efficacy and tolerance of the vaccine over a year, to evaluate the antibody profile, their kinetics, the fraction of neutralising antibodies and will also allow us to understand the attitudes to be taken to ensure the best protection for our staff

Our objective is to follow the hospital staff after vaccination, for this we will include two groups of participants:

G1: vaccinated staff who did not contract the virus (at the date of vaccination) and who had a serology \<0 at least at D7 of the date of vaccination dose 1 (known serological value) G2: vaccinated personnel who have contracted the virus with a PCR + and who have positive serology at least at D7 of the date of vaccination (known serological value)

Eligibility Criteria:
Inclusion Criteria:

RB-approved informed consent, age 18 years or older, male or female, anyone considering COVID-19 vaccination or anyone that has received COVID-19 vaccination.

Subjects can enroll at anytime after vaccination even though they may not have enrolled before vaccination.

Sampling Frequency and timing: Up to 8 total samples in 12 months -

Exclusion Criteria:

Exclusion: Failure to provide informed consent

-
Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study.

This is a multicenter open-label mode of action study. Twenty patients with moderate to severe hidradenitis suppurativa will be treated with guselkumab 200 mg Q4W subcutaneously. Main objectie is to investigate changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab, in HS lesional skin.

The total duration of the treatment period per subject is 16 weeks.


Eligibility Criteria:
Key Inclusion Criteria:

* moderate to severe HS
* treatment history of at least one systemic anti-inﬂammatory / immunosuppressive agent;
* HS diagnosis of at least 1 year;
* minimum of two anatomical locations with HS lesions
* minimum of 4 active abscesses and/or inflammatory nodules (AN).

Key Exclusion Criteria:

* contra-indication for guselkumab;
* previous use of guselkumab;
* use of treatment with biologics or any immunosuppressives for HS in the last 3 months prior to randomization;
* presence of other uncontrolled major disease;
* pregnant or lactating women
Risk Factors of Conversion From Local to General Sedation in Endovascular Stroke Therapy

Thrombectomy is now the standard of care of revascularization in acute ischaemic stroke. Data tend to show that final neurologic outcome is superior if the thrombectomy procedure was performed under conscious sedation.

The Rothschild Foundation is a high output centre with more than 400 thrombectomy procedures every year.

We report a rate of 5% of these procedures requiring general anesthesia despite conscious sedation being the standard of care. This study aims to identify clinical factors associated with a risk of conversion of a conscious sedation to a general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing thrombectomy for ischemic stroke
* age ≥ 18 years old

Exclusion Criteria:

* patient already under general anesthesia
* general sedation required
* haemorrhagic softening diagnosed before the beginning of procedure
* patient refusal to participate in the study
Efficacy and Safety of Iota-Carrageenan Eye Drops (NCX-4240)

This clinical investigation aims at demonstrating that NCX-4240 is effective and safe in decreasing the number of days where adenoviral conjunctivis is detected in the eye and in reducing the duration and/or the severity of the signs and symptoms of adenoviral conjunctivis

A multicenter, double masked, parallel, randomized 1:1 ratio clinical investigation comparing carrageenan eye drops (NCX 4240) versus placebo up to 21 days.

Total expected number of patients: 148

Randomization: patients will be randomized 1:1 between:

* Group A: eye drops containing iota-carrageenan (NCX 4240), 1 drop in each eye 8 times/day for 7 days (mandatory) then at least 4 to 8 times/day for the next 14 days until Day 21 or
* Group B: ocular lubricant eye drop (carmellose 0.5% sterile solution) 1 drop in each eye 8 times/day for 7 days (Mandatory), then 4 to 8 times/day for the next 14 days until Day 21.

Eligibility Criteria:
Inclusion Criteria:

* With uni-or bilateral acute adenoviral conjunctivis as diagnostised with adenoplus test
* Conjunctivis signs and symptoms in at least one eye AND positive adenoplus test in at least one eye whatever signs/symptoms and positive adenoplus test are from the same eye or not

Exclusion Criteria:

* Negative results with adenoplus test in both eyes
* a suspected bacterial, fungal, herpes, chlamydia or acanthamoeba co-infection, based on clinical investigation
The Effect of Facilitated-tucking and ShotBlocker on Pain Caused by Vaccination in Healthy Infants

This study will be investigated the effects of facilitated tucking, ShotBlocker and combined facilitated tucking and ShotBlocker methods on procedural pain, crying time and duration of the procedure during Hepatitis B vaccine administration in healthy term infants.

Hepatitis B vaccination is one of the painful procedures routinely performed in newborns. The pain experienced by the newborn negatively affects the prognosis of the disease, the infant's behavior, the harmony with the environment, the development of the brain and senses, as well as the family-infant interaction. Nonpharmacologic methods have been found to be effective in alleviating pain during interventions that cause pain caused by medical procedures that newborns frequently encounter. Facilitated tucking and ShotBlocker are effective methods that can be used in nonpharmacologic procedural pain management.

Studies have commonly used parent-related methods (kangaroo care, mother/father cuddling, breastfeeding, etc.) for neonatal pain management during Hepatitis B vaccine administration. In units where access to the parent is not always possible, nonpharmacologic pain methods that can be used independently of the parent can be used in the management of acute needle-related pain. In addition, no study was found in the literature comparing and combining the effect of fetal position and ShotBlocker application on hepatitis B vaccine-related pain. This study will be investigated the effects of facilitated tucking, ShotBlocker and combined facilitated tucking and ShotBlocker methods on procedural pain, crying time and duration of the procedure during Hepatitis B vaccine administration in healthy term infants.

Eligibility Criteria:
Inclusion Criteria:

* healthy term neonates
* born at 38-42 weeks gestational week,
* birth weight 2500-4400 g,
* 5th minute APGAR score above 6,
* in stable health,
* able to carry out vital activities without support,
* babies ordered Hepatitis B vaccine by the doctor

Exclusion Criteria:

* With a genetic or congenital anomaly,
* neurological, cardiological and metabolic diseases,
* in need of respiratory support,
* acute or chronic illness that causes pain,
* a complication of childbirth,
* infants of hepatitis B carrier mothers,
* nerve damage or deformity in the extremity to be vaccinated, scar tissue or incision in the vastus lateralis region,
* infants of mothers with a history of substance abuse