cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccines in the United Kingdom.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 2 months (42 to 98 days) at the time of enrollment.
2. Available for entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
3. Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
4. Parent(s)/legal guardian(s) had to be able to complete all relevant study procedures during study participation.

Exclusion Criteria:

1. Previous vaccination with licensed or investigational pneumococcal vaccine.
2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or meningococcal vaccines.
3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, pneumococcal conjugate, or meningococcal conjugate vaccines.
5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
6. Known or suspected immune deficiency or suppression.
7. History of culture-proven invasive disease caused by S pneumoniae, Neisseria meningitidis, or Hib.
8. Major known congenital malformation or serious chronic disorder.
9. Significant neurological disorder or history of seizure, including febrile seizure, or significant stable or evolving disorders, such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. This did not include resolving syndromes due to birth trauma such as Erb palsy.
10. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
11. Participation in another investigational trial. Participation in purely observational studies was acceptable.
12. Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.
Primary vs Secondary Closure of Tracheo-cutaneous Fistulas

The mean of this study is to compare primary and secondary closure of tracheo-cutaneous fistulas and evaluate the differences in outcomes between both techniques.

In this study the investigators wish to recruit patients with a tracheotomy that has been installed for various reasons and that is ready for closure. The investigators intend to randomly allocate them a mean of closure, either primary or secondary. Once the fistula is closed, the investigators will follow them over a substantial period of time to compare outcomes of each mean of closing. Different questionnaires will be used to best evaluate a range of variables.

Eligibility Criteria:
Inclusion Criteria:

* Being covered by the RAMQ
* Having a tracheostomy either percutaneous or surgical
* Being ready for canula removal and closure of the fistula

Exclusion Criteria:

* Presenting a contraindication to primary tracheotomy closure (granuloma)
* Unable to consent
* Refusal to participate
Study to Assess the Effectiveness of AboBoNT-A Injections for Adult Lower Limb Spasticity in a Real Life Cohort

The purpose of the protocol is to assess the longitudinal attainment of person-centered and function related goals of patients who receive AbobotulinumtoxinA (aboBoNT-A) injections for adult lower limb spasticity over a period of 16 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult male and female subjects ≥18 years of age
* Primary diagnosis with unilateral adult lower limb nonprogressive spasticity.
* Subject able to take more than five steps with or without assistance.
* Decision to treat the lower limb with aboBoNT-A by the care provider made prior to, and independently from, the decision to enroll the subject in the observational study as per country label.
* Previously untreated with BoNT-A (i.e. naïve to BoNT-A), or previously treated with a BoNT-A (i.e. non-naïve to BoNT-A). For those who were previously treated with BoNTA, they should have responded to BoNT-A treatment and at least 12 weeks should have elapsed from prior injection.
* Signed informed consent prior to participation in the study.

Exclusion Criteria:

* Prior history of nonresponsiveness to BoNT-A therapy
* Previous treatment with BoNT-A of less than 12 weeks prior to enrolment in study.
* Current participation in any other clinical study or have participated within the 12 weeks prior to the Inclusion visit (Visit 1) of this study.
* Severe limitations in passive range of motion/contractures in the affected limb (MAS=4 in at least one of the joints in the lower limb).
* Limb surgery or intrathecal baclofen therapy placement for spasticity within 3 months.
* Nonambulatory subject.
* Pregnant and lactating women.
* Progressive neurological conditions or diagnosis of cerebral palsy.
Vascular Physician Offer and Report (VAPOR) Trial

The purpose of the study is to see if vascular physicians (your provider) using a combination of proven smoking cessation tools in an organized way can help vascular patients quit smoking better than usual.

The doctors where you are being treated have been chosen to either provide:

the combination therapy of giving you advice, considering prescribing medications to help you quit smoking, and referring you to a phone quitline, or to continue their usual smoking cessation practices (which may include all, some, or none of the treatments above).


Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Current smoker
* Plan to have a Vascular Quality Initiative (VQI) procedure in \> 7 days

Exclusion Criteria:

* Pregnant Women, Fetuses and Neonates
* Children
* People with impaired decision-making capacity
E-health Cognitive Behavioral Therapy in Women Treated by in Vitro Fertilization (IVF)

Yearly, 15,000 Dutch in vitro fertilization (IVF) cycles are performed for subfertility with a pregnancy rate of 26%. A failed cycle has great emotional impact; 20-25% of the women has relevant forms of depression/anxiety even after 6 months. For such maladjustment a risk profile has been identified and translated into a screening tool. Identification of women at risk enables a timely and tailored (individual's needs) cognitive behavioral therapy (CBT), which reduces more serious maladjustment and corresponding costs.

Aim: To investigate the effectiveness of an e-health CBT (digital coaching, Digicoach) in women ongoing IVF and having been screened at risk.

Design: A single-centered randomised controlled trial comparing Digicoach (intervention) with standard care (control).

Digicoach: an e-health CBT with 4-12 weekly sessions starting before an IVF cycle, following a woman's IVF course and covering in modules the main problems: depressed mood, anxiety, strong focus on child wish and acceptance.

Main outcome measures: anxiety and depression occurrence rate 3 weeks after an unsuccessful IVF cycle. Secondary outcome measures: 1. (para)medical consumption, 2. quality of life, 3. productivity loss and 4. IVF outcome. Data are collected by questionnaires, diaries, medical record audit and page view registrations.

Process evaluation: Individual's use (e.g. module progress, completion rate), experiences, (e.g. satisfaction and usability) and potential barriers for implementation are evaluated.

Economic evaluation: studied during the Digicoach exposures from a societal perspective. Incremental costs (costs/%avoidance of depression/anxiety) are determined by comparing both study groups.

Power/data analysis: To detect a 29% difference in the depression/anxiety occurrence rates (alfa=0.05 and beta=0.80) 58 unpregnant IVF women are evaluated.


Eligibility Criteria:
Inclusion Criteria:

* women screened as 'at risk' for emotional maladjustment after In vitro fertilization (IVF) by a screening tool

Exclusion Criteria:

* impossibility to use Internet
* impossibility to write or read the Dutch language
* high screening scores requiring immediate intervention
Phase I/II Trial of KRN7000 in Patients With Chronic Hepatitis C Infection

Phase I/II trial of KRN7000 in patients with chronic hepatitis C.

Study objectives: To evaluate and compare the safety and tolerability of 3 ascending doses of a-GalCer.

The primary efficacy parameter: HCV-RNA response at the end of treatment. Secondary efficacy parameter: Serum ALT response. Further objectives of the study are to evaluate the effect of a-GalCer on serum cytokines IFNg and TNFa and on iNKT cells.

Number of dose levels: 3 Investigational product: KRN7000 Route of administration: intravenous Dosages and frequency: 0.1, 1, 10 mcg/kg, monthly injection, 3 times (day 0, day 28 and day 56)

Phase I/II trial of KRN7000 in patients with chronic hepatitis C.

This study is a multicenter double-blind randomized placebo-controlled phase I/II dose-escalation trial. The protocol is conducted in The Netherlands, Belgium and Germany. Patients with chronic hepatitis C who met the inclusion criteria are assigned to receive a-GalCer (KRN7000 ((2S, 3S, 4R)-1-O-(a-D-galactopyranosyl)-N-hexacosanoyl-2-amino-1,3,4-octadecanetriol), Kirin Pharmaceutical Co., Ltd., Gunma, Japan) or placebo intravenously, thrice with intervals of 4 weeks. Cohorts of 12 patients are entered at each of the three dose levels (0.1, 1 and 10 mg/kg body weight). Three patients per dose level are randomized to the placebo arm.

Dose escalation to the next cohort are decided after evaluation by a safety review board of all the safety data collected on all the patients who had completed 3 weeks after the first injection in the preceding dose cohort. After completion of 8 weeks of treatment, with injections at 0, 4 and 8 weeks, patients are monitored without further therapy for an additional 16 weeks.

Study objectives: The objective of the study is to evaluate and compare the safety and tolerability of 3 ascending doses of a-GalCer. The primary efficacy parameter is the response at the end of treatment, based on serum hepatitis C virus ribonucleic acid (HCV RNA) levels. As a secondary efficacy parameter serum ALT levels are evaluated. Further objectives of the study are to evaluate the effect of a-GalCer on serum cytokines IFNg and TNFa and on iNKT cells.

Eligibility Criteria:
Inclusion Criteria:

Chronic hepatitis C Liver biopsy within 3 years of entry into the study HCV RNA \> 10000 copies/mL Age 18-70 years ALT \> 1.2 times ULN written informed consent Adequate contraception

Exclusion Criteria:

Cirrhosis Decompensated liver disease ALT \> 10 times ULN Pregnancy Major other illness
Pilot for a Community Pharmacy Service Model: Impact of a Pharmacist Monitored Patient Blood Pressure Readings

This study is designed to explore whether routine measurement of blood pressure by community pharmacists can improve patient adherence to blood pressure medications. The study will utilize an incentivized care approach, in which patients receive a $10 gift card for every time they come to the pharmacy for blood pressure management (up to 2 times/month). The investigators hypothesize that the simple process of coming in for a blood pressure measurement (without any other scripted interventions, counseling, or consultation) will be feasible and sufficient to improve adherence to medications. The investigators will also collect preliminary data to help estimate how these hypothetical improvements in adherence might result in improved blood pressure control, fewer office visits, and (ultimately) fewer adverse cardiovascular outcomes (i.e. heart attacks, strokes, etc).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Diagnosis of hypertension
* Current prescription for ≥2 antihypertensive medications for primary diagnosis of hypertension
* Prior use of ≥1 antihypertensive medication for ≥6 months at the same Kroger's Pharmacy (#523)
* Willing and able to provide written informed consent

Exclusion Criteria:

* Age \<18 years
* New diagnosis of hypertension within the prior 6 months
* Current pregnancy or lactation
* Limited English Proficiency
* Use of antihypertensive medications for secondary prevention of cardiovascular events. Patients with history of acute myocardial infarction, stroke, heart failure will be excluded, however, patients with diabetes will be eligible for participation.
Thread Lift by Use of Retaining Ligaments

In facial rejuvenating surgery, the current trend calls for fewer and less noticeable scars with desired results. Especially to improve the jowls and nasolabial folds, the thread lift is a simple and inexpensive technique for patients who do not wish to undergo the typical facelift surgery, but the weak points of it are less effective and shorter duration than the conventional facelift.The investigators propose the new method of the thread lifting the subdermal and subcutaneous layer with a fiberoptic needle by use of the retaining ligaments with two fixation points on both temporal fascia and retaining ligaments. For the intraoperative evaluation the tensiometer was applied and for the postoperative evaluation the FACE-Q applied.

In facial rejuvenating surgery, the current trend calls for fewer and less noticeable scars with desired results. Especially to improve the jowls and nasolabial folds, the thread lift is a simple and inexpensive technique for patients who do not wish to undergo the typical facelift surgery, but the weak points of it are less effective and shorter duration than the conventional facelift.The investigators propose the new method of the thread lifting the subdermal and subcutaneous layer with a fiberoptic needle by use of the retaining ligaments.

Retrospective analysis was performed on 369 consecutive patients undergoing the suture suspension technique between January of 2012 and December of 2015, so called thread lift, using 3-0 V-Loc 180 device for facial rejuvenation with (n=305) or without additional facial procedures (n=64). The follow-up period ranged from 22 months to 43 months postoperatively, with a mean of 34.3 months. There are asymmetry(n=2), scar revision(n=1), revision(n=4), dimpling(n=1), suboptimal outcomes(n=9), and stitch abscess(n=1). The thread lift by use of the retaining ligaments with V-lock barbed sutures can be recommended as an alternative technique in the facelift.

Eligibility Criteria:
Inclusion Criteria:

* primary case
* secondary case

Exclusion Criteria:

* wide scar tissue on face
* allergy to foreign body(thread)
* no skin excess
A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China

This study is primarily designed to evaluate the IgG immune responses to the 13 pneumococcal serotypes induced by 13vPnC compared with the immune responses induced by 7vPnC when measured 1 month after the infant series, and to evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events and adverse events.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 42 to 77 days (approximately 2 months) at the time of enrollment.
2. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.

Exclusion Criteria:

1. Previous vaccination with licensed or investigational pneumococcal vaccine.
2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
3. Contraindication to vaccination with pneumococcal vaccines.
Pulmonary Hemodynamics During Exercise - Research Network

The purpose of this Clinical Research Collaboration is to investigate the prognostic implications of pulmonary hemodynamics during exercise based on a large scale multi-centre approach by using retrospective and prospective analysis of hemodynamic data.


Eligibility Criteria:
Inclusion Criteria:

* Patients (females and males; age: above 18yrs) with intermediate or high echocardiographic probability of PH and/or unexplained dyspnea, and/or associated conditions for PAH as clinical indication for RHC at rest and exercise
* Written informed consent of participating subjects after being fully briefed (for prospective analysis)

Exclusion Criteria:

* Patients with incomplete hemodynamic data at rest or exercise
* Patients without sufficient follow-up data (information on survival / lung transplantation)
* advanced tumour disease or other diseases with a short life expectancy, except pulmonary vascular diseases
* advanced heart failure with pulmonary arterial wedge pressure (PAWP) \> 18 mmHg at rest
* uncontrolled systemic arterial hypertension (RR values \> 160/100 mmHg at rest)
* FEV1\<50% predicted
* TLC\<60% predicted
IC-8 Apthera IOL New Enrollment Post Approval Study

The purpose of this study is to verify the post-market safety of the IC-8 Apthera IOL after the treatment of posterior capsular opacification (PCO), an expected complication related to IC-8 Apthera IOL implantation.

Prospective, multi-center, single-group, non-randomized new enrollment post approval study to assess the post-market safety of the IC-8 Apthera IOL after Nd:YAG laser capsulotomy following sufficient surgeon training of the sponsor-recommended standardized Nd:YAG laser capsulotomy technique. All subjects will undergo approximately 6 study visits and will be followed 24 months post IC-8 Apthera IOL implantation. There is one study group: subjects previously implanted with the IC-8 Apthera IOL and who have developed posterior capsular opacification (PCO) which requires treatment with Nd:YAG laser capsulotomy.

Eligibility Criteria:
Inclusion Criteria:

* 22 years of age or older, any race and any gender;
* Posterior capsule opacification (PCO) requiring treatment in the IC-8 Apthera IOL eye
* Able to comprehend and have signed a statement of informed consent;
* Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits;
* Clear intraocular media in both eyes;
* Preoperative corneal astigmatism ≤1.5 D in the IC-8 Apthera IOL eye prior to IC-8 Apthera implantation;
* Prior IC-8 Apthera IOL implantation in one eye and a monofocal/monofocal toric IOL in the other eye in accordance with the directions for use (DFU) for each IOL.

Exclusion Criteria:

* Pharmacologically dilated pupil size less than 7.0 mm in the IC-8 Apthera IOL eye;
* Irregular astigmatism in either eye;
* History of retinal disease;
* Active or recurrent anterior segment pathology;
* Presence of ocular abnormalities;
* Diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye treatment;
* Previous corneal or intraocular surgery, except cataract surgery;
* History of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention;
* Acute, chronic or uncontrolled systemic disease that would, in the opinion of the investigator, confound the outcomes of the study;
* Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with hormonal fluctuation that could lead to refractive changes and dry eye;
* Concurrent participation or participation in any clinical trial up to 30 days prior to the first visit in the study.
* Subjects who plan to be traveling, relocating or otherwise unavailable to attend any of the visits
Hexoskin Feasibility Study With COVID-19 Patients

This pilot study aims to investigate the feasibility of using Hexoskin cardiorespiratory and activity data, as well as patient symptomatology, to provide an AI model for disease progression that will be at the service of the clinical team to recommend the best customized and evolving care trajectory for each patient.

The following protocol proposes a mixed methods pilot study, whereby the immediate purpose is to generate quantifiable information regarding the feasibility of a virtual trial with the Hexoskin Platform, collection of data quality in COVID-19 patients, and values for algorithm construction. In essence, sixteen participants with a confirmed COVID-19 diagnosis will be invited to wear the Hexoskin biometric garment during the course of several hours per week, over a period of 28 days. In addition to the biometric data collection, participants will be invited to complete four questionnaires. The biometric data will be combined to the sociodemographic information and patient symptomatology to construct an algorithm which can accurately predict patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Minimum waist size of 24 inches, and maximum waist size of 45 inches
* Confirmed COVID-19 diagnosis from a licensed healthcare practitioner
* Permanent resident or citizen of the United States
* Access to a smartphone
* Access to a functional email
* Access to a thermometer
* Access to a measuring tape
* Experiencing at least three of the following COVID-19 symptoms (fever, cough, difficulty breathing, intense fatigue, sudden loss of smell and/or taste without nasal congestion, sore throat, headache, aching muscles, loss of appetite, diarrhea).

Exclusion Criteria:

* Hexoskin should not be used by people with allergies to the following materials: polyester, synthetic fibers. Usage must be stopped if the product causes skin irritation or rashes.
* Hexoskin should not be used by people with Pacemakers or Implantable Cardioverter-Defibrillator (ICD) devices.
* Hexoskin must not be used simultaneously with a Holter Monitor, as the equipment would interfere with the placement of the Hexoskin sensors.
* Hexoskin must not be used in an MRI machine as it contains metallic parts.
* Individuals who do not fit any of the Hexoskin Shirts sizes (Men: between 2XS - 6XL, Women: between 2XS - 4XL).
* Individuals who have a documented medical condition or illness requiring intensive medical treatment.
* Women of Childbearing Potential whom are not using effective contraceptive measures
Prevention of Melasma Relapse During Summertime

Main objective is to show that a photoprotective sunscreen having a protection against the visible light is more effective than a sunscreen having the same UVA AND UVB protection but with a low (weak) protection against the visible, to prevent the relapses of the melasma during the summertime.

40 melasma affected women will be included and randomized in two parallel groups (one group protected by a UVA+UVB+visible extended sunscreen and one group group protected by a UVA+UVB sunscreen).

There will be 3 visits: Baseline, T2.5months and T5months (final visit).

Products application frequency: twice daily(morning and afternoon) and additional applications every 2 hours in case of solar exposure.

Main evaluation criterion: the MASI score assessed from standardized photographs (system VISIA, Canfield Scientific, USA) at Baseline, middle and end of study.

Eligibility Criteria:
Inclusion Criteria:

* Melasma

Exclusion Criteria:

* Other pigmentary disorders associated (including PIH)
Incidence and Predictive Factor of Irritable Bowel Syndrome After Acute Diverticulitis in Korea

The pathogenesis of irritable bowel syndrome (IBS) is considered immune reaction of gastrointestinal tract. Therefore there is growing evidence that IBS could occur after gastroenteritis. However, little is known about the incidence of IBS after acute diverticulitis. We thought that post diverticulitis status could induce IBS because diverticulitis was also bowel inflammatory disorder. This survey was designed to identify incidence of post-diverticulitis IBS and risk factor in Korea.


Eligibility Criteria:
Inclusion Criteria:

* 20 years or over
* Patients who diagnosed diverticulitis by CT scan from 2006 to 2010 (Case)
* Patients who admitted to hospital because of non-gastrointestinal disorder (Control)

Exclusion Criteria:

* Patients who diagnosed IBS before diverticulitis (Case)
* Patients who diagnosed IBS before admission (Control)
* Patients with bowel resection surgery except for laparoscopic appendectomy
* Pregnancy
* Do not agree the consent of this study
* Patients who dose not understand telephone survey such as foreigner, mental retardation.