cyrilzakka/clinical-trials huggingface dataset:
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure

Primary care visits are a key aspect of clinical care focused on helping patients to close care gaps related to preventive care such as vaccination, diabetes testing, statin therapy and cancer screening. However, less than 50% of care gaps are closed during these visits and new approaches are needed to prime patients for a discussion during these visits. In this study, the study team will evaluate a health system initiative that uses text messaging to patients in days preceding a primary care visit to prime patients to be amenable to ordering of vaccination, diabetes testing, cancer screening, and statin prescribing.

The United States Preventive Services Task Force has recommended tests and treatments for vaccination, diabetes testing, statin therapy, and cancer screening. These preventive services have been demonstrated to reduce illness and improve quality of care. Yet, more than 50% of open care gaps go unaddressed during primary care visits.

Nudges are subtle changes to the way information is framed or choices are offered that can have a significant impact on behavior. In a previous randomized clinical trial, text messages sent to patients prior to primary care visits increased vaccination by up to 11% relative to control. The most effective message told patients the influenza vaccine was "reserved for you," and sent two text messages to patients in the 3 days preceding a primary care appointment.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Have documented consent to communicate electronically
* Have a visit scheduled with a primary care practice
* Have at least one open care gap among those in the intervention

Exclusion Criteria:

* No phone number on file to send text messages
A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics and Safety of an Oral Contraceptive in Healthy Volunteers

The purpose of this study is to investigate whether there is a drug-drug interaction between multiple doses of canagliflozin (JNJ-28431754) and single doses of an oral contraceptive containing ethinyl estradiol and levonorgestrel. The safety and tolerability of canagliflozin will also be assessed in healthy volunteers.

This study will be an open-label (all volunteers and study staff know the identity of the assigned treatment), single-center, fixed-sequence study (all volunteers receive the same medication on the same days), to determine how canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) affects the pharmacokinetics (ie, how the body affects the drug) of an oral contraceptive containing ethinyl estradiol and levonorgestrel. The study will consist of 3 phases; a screening phase, an open-label treatment phase, and an end-of-study (or follow-up) phase. Each volunteer will participate in the study for approximately 33 days.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer must have a body mass index (weight \[kg\]/height \[m2\]) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
* Volunteer must be a non-smoker (has not used tobacco or nicotine products in 6 months)

Exclusion Criteria:

* History of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
* History of, or presence of, disorders commonly accepted as contraindications to sex hormonal therapy and contraindications to therapy with combined oral contraceptives
* Volunteer has used, or is currently using, any hormonal contraceptive within 30 days of admission to the study center or has received Depo Provera (or other combined contraceptive injection or hormonal contraceptive implant) in the 6 months prior to screening
* Volunteer is breast-feeding
Antimicrobial Photodynamic Therapy as an Adjunct Treatment for Periodontal Disease in Down's Syndrome Patients

The aim of this study was to evaluate the effectiveness of antimicrobial photodynamic therapy as an adjuvant of scaling and root planning for treatment of periodontal disease in patients with Down's Syndrome. After scaling and root planning, half of patients received antimicrobial photodynamic therapy with methylene blue dye and laser and the sessions were repeated after 3, 7 and 14 days. The other half received only scaling and root planning.

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Antimicrobial photodynamic therapy (aPDT) has been widely used in Periodontics to obtain reduction of periodontopathogenic bacteria with absence of systemic side effects and minimal bacterial resistance. Therefore, a good adjuvant alternative for periodontal disease treatment arises, especially for patients with Down syndrome (DS) who present greater severity and high prevalence of periodontal disease. Usually aPDT is used as an adjunct therapy to scaling and root planning.

Eligibility Criteria:
Inclusion Criteria:

Down's Syndrome Diagnose characterized by the whole chromosomal aneuploidy 15 to 52 years Absence of severe hearing loss could impair the comprehension about the dental treatment Absence of severe visual loss that could impair the comprehension about the dental treatment Presence of at least four teeth being one for hemiarch. Diagnose of gingivitis and periodontitis Absence of acute periodontal disease and necrotizing periodontal disease

Exclusion Criteria:

Smokers Use of alcohol Menopause Pregnancy Absence of all teeth Uncontrolled diabetes mellitus Uncontrolled hyperthyroidism Angina Uncontrolled hypertension Coagulopathy Use of illicit drugs Head and neck radiotherapy Chemotherapy Non-cooperative patients or patients with other diseases as autism.
Prevention of Postpartum Smoking Relapse in Mothers of Infants in the Neonatal Intensive Care Unit (NICU)

The investigators hypothesized that an enriched focus on mother-infant bonding during a newborn's hospitalization in the Neonatal Intensive Care Unit would reduced the rate maternal postpartum smoking relapse and would prolong the duration of breastfeeding in mothers who had quit smoking during or just prior to pregnancy.

Mothers of newborns admitted to the Neonatal Intensive Care Unit (NICU), who had quit smoking during or just prior to pregnancy where randomized to either the Standard of Care or Smoking Relapse Prevention group. Mothers in both groups were encouraged to remain smoke free following the birth of their babies and were given routine lactation support for breastfeeding during their babies' hospitalization in the NICU. Mothers in the Smoking Relapse Prevention group were also given the study intervention, which was enhanced support for maternal-infant bonding by providing information about their newborn's behaviors using books, DVDs, and handouts that were appropriate for their baby's gestational age and by encouraging frequent skin-to-skin holding.

Primary outcomes included duration of smoke-free status and duration of breastfeeding.

Eligibility Criteria:
Inclusion Criteria:

* Mothers:

  * Who had quit smoking during pregnancy or within one year prior to pregnancy
  * Who had newborns \< 1 week old at the time of admission to our NICU.

Exclusion Criteria:

* Mothers:

  * Who were smokers at the time of delivery
  * Whose infant's length of stay \< one week
  * Who were not available (jail, adoption)
  * Who had a history of drug use
  * Who did not speak English
Effect of Renal Impairment on Enpatoran Pharmacokinetics

The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics of enpatoran.


Eligibility Criteria:
Inclusion Criteria:

For Control Group 1 (Normal Renal Function):

* Medical history and physical examination without any ongoing clinically relevant findings as judged by the Investigator
* No clinically relevant findings (only minor deviations) in biochemistry, hematology, coagulation, and urinalysis examinations for the age of the participant, as judged by the Investigator; absolute lymphocyte count and absolute neutrophil count must be within normal limits

For Group 2 (Impaired Renal Function):

* Medical history and physical examination without any ongoing clinically relevant findings except for the underlying disease leading to renal impairment and consequence diseases thereof
* Chronic kidney disease
* For participants under medication, stable medication for at least 1 month
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* History or presence of respiratory, gastrointestinal (including bariatric or other gastric surgeries, or other conditions that may affect drug absorption), hepatic (including hepatorenal syndrome), hematological, lymphatic, cardiovascular (such as ventricular dysfunction and congestive heart failure, cardiac arrythmia), psychiatric, neurological, genitourinary, immunological, dermatological, connective tissue diseases, or disorders that may affect the safety of the participant.
* History of drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other hypersensitivity reaction in general, which may affect the safety of the participant and/or outcome of the study per the Investigator's discretion
* History or presence of epilepsy, neurological disorders with seizure propensity or undiagnosed loss of consciousness, severe head trauma within 6 months or severe depression within 12 months prior to Screening), or neuropsychiatric conditions
* History of serotonin syndrome
* Prior history of cholecystectomy or splenectomy, and any clinically relevant surgery within 6 months prior to Screening, which might interfere with the objectives of the study or the study procedures
* Other protocol defined exclusion criteria could apply
A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain

This is a multicenter randomized, double-blind, placebo-controlled phase 2 study to evaluate efficacy, safety, tolerability, pharmacokinetics, and target engagement of GSK3858279 in adult participants with chronic Diabetic Peripheral Neuropathic Pain (DPNP). The primary objective of the study is to assess the efficacy of GSK3858279 in participants with DPNP who have been unable to sufficiently manage their pain.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be 18-75 years of age inclusive, at the time of signing the informed consent.
* Type I or Type II diabetes with painful, distal, symmetrical, sensory motor neuropathy attributed to diabetes, of at least 6 months duration.
* A pain score ≥4 and less than or equal to (≤) 9 by the 11-point NRS (0-10) for average daily pain intensity over the past 24 hours at the screening visit.
* Body mass index (BMI) within the range 18-40 kilogram per meter square (kg/m\^2) (inclusive)
* Capable of giving signed informed consent.

Exclusion Criteria:

* History or presence of cardiovascular, renal, gastrointestinal, lymphatic disorders which in the opinion of the investigator would interfere with the study procedures and/or assessments.
* Participant has current painful peripheral neuropathy due to a cause other than diabetes (e.g. pernicious anemia, hypothyroidism, post-herpetic neuralgia).
* History of significant allergies to monoclonal antibodies.
* Current enrolment or past participation in a clinical study of an investigational medicinal product intervention within the last 30 days or 5 half-lives (whichever is longer) of signing consent.
* Participants who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits, inability to complete the eDiary daily etc.) and/or otherwise considered by the Investigator to be unlikely to complete the study.
Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy

The use of nasogastric (NG) decompression after pancreaticoduodenectomy (PD) is a current practice. NG tube is associated with a high rate of morbidity including pulmonary morbidity, delayed gastric emptying and finally an increased length of hospital stay.

The absence of NG decompression could be the corner stone of the concept of the enhanced recovery program after PD.

The use of nasogastric (NG) decompression after pancreaticoduodenectomy (PD) is a current practice. NG tube is associated with a high rate of morbidity including pulmonary morbidity, delayed gastric emptying and finally an increased length of hospital stay. In the era of the enhance recovery after major abdominal surgery, the place of the NG tube remains unproven after PD even if NG tube is clearly abandoned in liver, stomach and colonic surgery. Nowadays, only few retrospective series had reported the feasibility of the absence of nasogastric tube after PD, but not with a randomized control trial. The absence of NG decompression could be the corner stone of the concept of the enhanced recovery program after PD.

The objective of this prospective randomized monocentric study is to evaluate the impact of the absence of NG decompression after PD.

The aim of the study is to decrease postoperative morbidity after PD including pulmonary and delayed gastric emptying complication. The impact of the absence of systematic NG decompression could be interesting in terms of public health with a decreased of length of hospital stay. Furthermore, this is the first randomized study comparing NG tube decompression after PD to absence of NG tube after PD which would bring relevant elements to improve the recovery after PD.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years and ≤ 75 years
* patient requiring a PD for benign of malign pathology of the bilio and pancreatic intersection
* patient giving free and informed consent

Exclusion Criteria:

* previous gastric of esophagus surgery
* sever comorbidity such as : end stage renal disease, respiratory failure, heart failure (≥ 3 NYHA)
* Person with a measure of legal protection (guardianship)
* Pregnant woman or nursing mother
What Are the Determinations of Adult Progressive CKD? The Renal Impairment In Secondary Care (RIISC) Study

Chronic kidney disease (CKD) affects up to 16% of the adult population and is associated with significant morbidity and mortality. People at highest risk from progressive CKD are defined by a sustained decline in estimated glomerular filtration rate (eGFR) and/or the presence of significant albuminuria/proteinuria. Accurate mapping of the bio-clinical determinants of this group will enable improved risk stratification and direct the development of better targeted management for people with CKD. To address these requirements we have established the Renal Impairment in Secondary Care (RIISC) study; RIISC is enrolling a cohort of patients at high risk from progressive CKD and compiling a comprehensive and detailed bio-clinical phenotype, including vascular and oral health phenotyping, at enrolment and on subsequent follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Decline of eGFR of ≥5mls/min/year or ≥10mls/min/5years
* and/or urinary albumin-creatinine ration (ACR) ≥70 mg/mmol on three occasions
* and/or CKD 4 or 5 (pre-dialysis)

Exclusion Criteria:

* renal replacement therapy
* immunosuppression
A Study to Evaluate the Safety and Effectiveness Assessments of Restylane-Defyne for Punctual Occlusion

A study which participants with mild to moderate dry eye disease will have a punctum of one eye injected with 0.1ml Restylane Defyne and the other eye injected with 0.2ml Restylane Defyne. Participants will be evaluated over four visits.


Eligibility Criteria:
Inclusion Criteria:

* 21 to 80 years of age
* Baseline OSDI score of at least 13 with no more than 3 responses of "not applicable"
* In both eyes, a baseline Schirmer test with anesthetic of ≤ 10mm/5 minutes
* Literate, able to speak English and able to complete the questionnaire independently
* Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol.

Exclusion Criteria:

* Use of ophthalmic cyclosporine or lifitegrast within 30 days prior to Day 0
* History of surgical punctal occlusion (e.g., cautery), canalicular infection or canalicular surgery
* Corneal transplant in either eye
* Ocular surgery (such as cataract surgery or LASIK) in either eye within six months of the Baseline Visit
* A systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease)
* The history or presence of any ocular disorder or condition in either eye that, in the opinion of the investigator, would interfere with the interpretation of the study results (e.g., significant corneal or conjunctival scarring, pterygium or nodular pinguecula; current ocular infection (except mild blepharitis), conjunctivitis or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; history of ocular herpetic infection; evidence of keratoconus; lid or lacrimal cancer.
* Active severe systemic allergy, seasonal allergies, rhinitis or sinusitis requiring changes in treatment within 30 days prior to the study or likely to require changes in treatment during the course of the study (i.e. antihistamines, decongestants, oral, topical or aerosol steroids)
* Participation in a clinical trial during the past 30 days
* Women who are pregnant, planning a pregnancy, or nursing at study entry.
Eosinophil-guided Reduction of Inhaled Corticosteroids

Clinical trial on eosinophil-guided time-updated person-specific reduction of inhaled corticosteroid (ICS) therapy and prophylactic azithromycin therapy in patients with severe or very severe chronic obstructive pulmonary disease (COPD) receiving long-acting b-agonist (LABA) / long-acting muscarinic receptor antagonists (LAMA) / ICS treatment.

Inhaled corticosteroid (ICS) treatment is recommended by Global Initiative for Obstructive Lung Disease (GOLD) for patients with frequent and/or servere exacerbations and blood eosinophils \> 0.3 x 10\^9 cells/L and in those with ≥ 0,1 x 109 cells blood-eosinophils and recurrent exacerbations while on bronchodilators. ICS treatment, however, is associated with side effects such as diabetes, osteoporosis and pneumonia which is costly for both patients and society. By studying the effects of a personalized, eoseosinophil-guided approach to direct ICS in COPD patients with frequent AECOPDs through a randomized clinical trial this study will examine the possibilities of reducing ICS overtreatment and thus ICS-related adverse events.

Long term ICS treatment is known for affecting the bacterial load in stable COPD patients. Azithromycin exerts multiple effects on the structure and composition of the lower airway microbiota and has anti-inflammatory effects. This study will, moreover, investigate whether an oral low-dose prophylactic treatment with Azithromycin 250 mg three times weekly can reduce the number of moderate-severe AECOPD and improves time alive and out of hospital.

This study is a randomized, double-blinded, multicentre, four-arm intervention clinical trial and is conducted based on the principles of good clinical practise (GCP).

Eligibility Criteria:
Inclusion Criteria:

* COPD (verified by a specialist in respiratory medicine + spirometry)
* GOLD class E anytime within the last 2 years (corresponding to 2 ≥ AECOPD and/or ≥1 AECOPD leading to hospitalization during a 12 months period within the last 2 years) and/or FEV1\<30%.
* Treatment for last 4 weeks including LAMA, LABA and ICS
* Informed consent

Exclusion Criteria:

* Known asthma.
* Male \< 40 years.
* Female \<40 years, if non-menopausal (had menstruation within the last 12 months) conditioned by a negative urine HCG test
* Severe mental illness which considerably complicates co-operation.
* Language problems that considerably complicate co-operation.
* Current treatment with systemic corticosteroids corresponding to \> 5 mg prednisolone per day.
* Systemic antibiotic treatment (if to participate in microbiota sub-study) or systemic corticosteroid treatment within 14 days (also prophylactic Azithromycin).
* Contra-indication to treat with Azithromycin (as listed by the producer).
* Non-bacterial exacerbation per investigator judgement in the last 3 months.
Vibrotactile Stimulation for Upper-Extremity Stroke Rehabilitation

The goal of this clinical trial is to investigate upper-extremity vibrotactile stimulation with wearables in stroke patients. The main questions it aims to answer are:

Are the wearables well-tolerated by patients? Does the vibrotactile stimulation help regain arm function?

Participants will wear vibrotactile stimulation gloves and shirts for 5 hours daily during their stay at the rehabilitation unit, in addition to conventional therapy. Researchers will compare the treatment group (vibrotactile stimulation wearables) with a control group (conventional therapy only) to see the effects of the vibrotactile stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Inpatients at rehabilitation units
* Unilateral left or right sided ischemic stroke within the previous 2 weeks
* Have Upper-Extremity Fugl-Meyer scores between 6 and 58
* Have at least 20 degrees of active shoulder elevation and elbow flexion
* Expected to stay 1-3 weeks in the rehabilitation unit

Exclusion Criteria:

* Under anti-spasticity therapy
* Patients that are dependent on pacemakers
* Patients that have defibrillators
* Have lymphedema or AV fistula for dialysis on an arm
An Analysis of the Quality of Life and Sexual Quality of Life of Cervical Cancer Radiotherapy Patients

Cervical cancer radiotherapy patients have a decline in quality of life and sexual quality of life

Objective: To investigate the quality of life and sexual quality of life and its influencing factors in cervical cancer undergoing radiotherapy patients.

Methods:The cervical cancer cancer scale (FACT-Cx4.0) and the female sexual function index (FSFI) in the cancer treatment function evaluation system were used. The quality of life and sexual quality of life of cervical cancer patients undergoing radiotherapy in PUMC Hospital were analyzed and scored to analyze the effects of age, education level, clinical stage and treatment methods on the quality of life and sexual quality of life of cervical cancer radiotherapy patients

Eligibility Criteria:
Inclusion Criteria:

* adult female
* diagnosed with cervical cancer' and acquire therapy as part of treatment
* undertaken or have finished radiotherapy in Peking Union Medical College Hospital
* agreed with informed consent

Exclusion Criteria:

* with cognitive dysfunction or cannot fulfilled the questionaire
* refuse or quit the research
* submit questionnaire with missing information
Vivity Outcomes in Patients With Early Stage Glaucoma

The goal of the study is to determine the visual outcomes in patients with mild, pre-perimetric glaucoma who undergo cataract surgery with implantation of the Alcon Vivity Extended Range Intraocular Lens (IOL).


Eligibility Criteria:
Inclusion Criteria:

1. Patients at least age 45 years of age undergoing uncomplicated cataract surgery with optional concomitant minimally invasive glaucoma surgery (MIGS)
2. Subjects with documented diagnosis of pre-perimetric glaucoma
3. Calculated lens power within Vivity/Vivity toric range
4. Willing and able to comprehend informed consent and complete 4-6 month post-op visit
5. Potential postoperative BCDVA of 20/20 or better in each eye based on Investigator's medical opinion

Exclusion Criteria:

1. Ocular comorbidity, other than pre-perimetric glaucoma, that could reduce the potential postoperative BCDVA
2. Previous ocular surgery including refractive surgery
3. Subjects who are pregnant or plan to become pregnant during the course of the study.