cyrilzakka/clinical-trials huggingface dataset:
Teens-Connect: Preventive Psycho-education for Transitioning Teens With Diabetes

The purpose of this study is to evaluate the use of a state-of the art internet psycho-educational program in clinical practice (Teens-Connect), compared to use of a standard and widely available internet diabetes program for youth (Planet D™) in a mixed-method randomized clinical trial design.

The aims are:

1. To evaluate the efficacy and cost-effectiveness of provider-prescribed Teens-Connect (TEENCOPE™+Managing Diabetes) in pediatric diabetes practice compared to prescription of Planet D™.

   The hypotheses to be studied are:
   1. Youth who participate in Teens-Connect will have better metabolic control (A1c) and quality of life (QOL) than those who participate in Planet D.
   2. These effects will be mediated by improvements in stress/coping, self-efficacy, diabetes problem-solving, and self-management.
   3. Teens-Connect prescribed by providers in diabetes clinics will be a cost-effective approach to reduce A1c and improve quality-adjusted life years (QALYs) for youth with T1D.
2. To compare the reach, efficacy, adoption, implementation, and maintenance (RE-AIM) of the two provider-prescribed psycho-educational internet programs.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 1 diabetes for at least 6 months
* Age 11 to 14 years
* English-speaking
* Assent
* Parent/guardian consent to participate in study

Exclusion Criteria:

\*Previous exposure to TEENCOPE and/or Managing Diabetes
The Effect of Self-Efficacy Promoting Program Using Computer Game on Proteinuria in Thai Children With Nephrotic Syndrome

Nephrotic syndrome is a medical condition where the kidneys release substantial amounts of protein into the urine, resulting in various issues such as tissue swelling and an increased susceptibility to infections. Emphasizing the importance of adequate nutrition and symptom monitoring is crucial in managing urine protein levels and mitigating associated complications.

The purpose of this study was to boost self-efficacy through a computer game-based program, aiding pediatric patients with Nephrotic syndrome in the adoption of healthy eating habits and efficient management of urine protein levels.

This study was Quasi-experimental Research. Two group pre-test post-test with repeated measures design. Forty school-age children diagnosed with nephrotic syndrome were randomly allocated into two groups, with the participants distributed between an experimental group and a control group, each comprising 20 individuals. The experimental group underwent a program that aimed to enhance self-efficacy through computer games for a duration of 5 weeks, whereas the control group received regular nursing care. Information was gathered through personal record forms, urine protein assessments with test strips, dietary behavior surveys for school-age children with nephrotic symptoms, and self-efficacy surveys related to dietary behavior within the same group. The data underwent analysis using repeated measures analysis of variance. Statistical significance was defined as p \< .05.

Eligibility Criteria:
Inclusion Criteria:

* Confirmation of nephrotic syndrome diagnosis by a physician and continuous hospital treatment for a minimum of 3 months.
* Presence of proteinuria levels at 1+ or higher during morning awakening or a urine protein quantity exceeding 30 mg/dL within the past 6 months (verified through medical records).
* Proficient communication skills in the Thai language.
* Ownership of a telephone or device suitable for gaming and internet connectivity.
* Willingness and cooperation from both the family and the child to actively participate in the research.
* Discontinuation of steroid medication by school-age patients.

Exclusion Criteria:

* involve symptoms indicative of a critical condition, such as entering a crisis or severe complications like heart failure or pleural effusion.
* school-age patients whose treatment plan has been modified by a physician, including the use of injectable medication instead of oral drugs or those receiving treatment in an inpatient setting.
Description and Prognostic Evaluation of Four Biological Parameters of Blast Cells in Adult Acute Lymphoblastic Leukemia

Adult acute lymphoblastic leukemia treatment approaches relie on risk stratification, including cytogenetics. We want to study at diagnosis several blast cells parameters on frozen samples of GRAALL protocols enrolled patients:

1. A CD45-DNA double staining analysed by flow cytometry will allow mesurement for each blastic clone of DNA ploidy, percentage of cells in S-phase, CD45 fluorescence index.
2. The proteine P16 metabolic way, involved in cell cycle regulation, will be studied by Western Blot analysis.

The comparison between these parameters, and main haematological data, will be followed by a prognostic analysis, based on blast corticosensibility in vivo, chimiosensibility, complete remission, and survival.

Combination of the studied parameters will allow to appreciate a clonal diversity. This will help to predict, at diagnosis, high probability of resistance to treatment.


Eligibility Criteria:
Inclusion Criteria:

* All GRAALL 2003 and 2005 enrolled patients with available frozen blast cells

Exclusion Criteria:

* None
Comparison of Optical Quality With Different Placement of Refractive Multifocal Intraocular Lens

The study aims to compare postoperative optical quality between two different implanting position of a rotationally asymmetric MIOL \[SBL-3 Lenstec; +3.00 diopters (D)\], angle kappa based implantation and 0 to 180 degree implantation, in order to find out the optimal implantation position for SBL-3.

SBL-3 has been proved to provide patients with good near, intermediate and distant visual acuity, but there is not much study on the impact of SBL-3 position on postoperative visual acuity.The regional refractive design of SBL-3 means it could be affected by pupil center shift (described by angle kappa: the difference between visual axis and pupil axis), the investigators assume that maintaining the ideal ratio of distant and near segment(50% vs 42%) in the pupil center could yield both good distant and near postoperative visual acuity postoperatively. Therefore, the investigators designed the implantation by placing the IOL based on angle kappa to make sure the ratio of distant and near segment exposure in the pupil center close to 50:42. In this study, the investigators assessed the optical quality in patients with SBL-3 implantation based on angle kappa and 0 to 180 degree to provide surgeons with information for choosing appropriate implantation position for optimum postoperative satisfaction of SBL-3.

Eligibility Criteria:
Inclusion Criteria:

* age related cataract
* underwent bilateral cataract surgery and SBL-3 implantation
* corneal astigmatism \<1.5D

Exclusion Criteria:

* patients with active ocular inflammation
* neuro-ophthalmic disease and macular disease
* previous corneal or intraocular surgery, corneal opacities or disease
* patients had surgical complications, pupillary trauma, inability to place the lens in the capsular bag
* IOL tilt or decentration deviated from intraoperative positioning
* difficulties with examinations and follow-up
Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products

Multiple-dose nicotine pharmacokinetics with three oral nicotine replacement products. A study in healthy smokers.

Fifty (50) healthy male or female subjects between the ages of 19 and 50 years, inclusive, smoking at least 20 cigarettes daily during at least one year preceding inclusion. Multiple doses of all study treatments are given either every 60 minutes or every 90 minutes, respectively. All products will be administered in accordance with labeling, on five separate treatment visits. The subjects will abstain from smoking from 8 pm in the evening before and until the end of each visit.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects, smoking at least 20 cigarettes daily during at least one year preceding inclusion.
* BMI between 17.5 and 30.0 kg/m2 and a total body weight of at least 55.0 kg.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.
* Willing and able to comply with all scheduled visits and study procedures

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy.
* Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.
* Any medical condition or history that might, per protocol or in the opinion of the investigator, compromise subject safety or trial results.
Survival Rates and Quality of Life According to Follow-up Period After Gastrectomy for Gastric Cancer (STOFOLUP)

This study is a multi-center, prospective, randomized controlled study. The aim of this study is to compare survival rates and to observe quality of life and nutritional status according to follow-up period in patients who underwent radical gastrectomy for stage 2 or 3 gastric cancer.

The hypothesis of this study is that the survival rates would be different between the 3 months and 6 months follow-up groups. The investigators expected survival differences of 6% and the anticipated 3-year overall survival is 83% in the 6 months follow-up group based on the previous 3 phase clinical trial. On the basis of this hypothesis, the sample size was calculated as 886 patients.

Patients who were diagnosed as stage 2 or 3 gastric cancer after gastrectomy will be assigned to 3 months or 6 months follow-up group. The planned examinations including blood test, X-ray , CT, endoscopy, and nutritional markers will be performed according to the protocol and each patients will be followed up for 3 years after enrollment.

The primary endpoint is 3 year overall survival and secondary endpoints are other survivals such as 3-year disease-free survival and gastric cancer specific survival, quality of life, and nutritional parameters.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 19 years or more
* Patients who are diagnosed with pathological stage II or III gastric adenocarcinoma according to the AJCC 8th edition
* Patients who can understand all information about the trial and decide for themselves whether to participate in this study

Exclusion Criteria:

* Vulnerable patients such as pregnant and intellectual disability
* Patients who cannot undergo CT owing to poor kidney function or severe adverse effects
* Patients who are already in another study and cannot follow the schedule for this trial
* Patients who are diagnosed with a cancer other than gastric cancer within five years before the gastrectomy
* Patients being treated for a cancer other than gastric cancer
Effect and Efficacy of Xpedition™/Alpine™, Everolimus-eluting Stent for Coronary Atherosclerosis

The objectives of this study are

1. To establish a prospective registry of the whole patients who received percutaneous coronary intervention with Xience Xpedition™/Alpine™ stent
2. To evaulate the long-term efficacy and safety of coronary stenting with the Xience Xpedition™/Alpine™ stent
3. To compare the long-term efficacy and safety of coronary stenting between the Xience Xpedition™/Alpine ™ stent and other contemporary drug-eluting stents which had established their own registry

Secondary endpoints of this study are

Stent thrombosis-24 hours(acute), 30 days(subacute), 1 year(late), every 1 year till 3 years(very-late) after index PCI

Target vessl failure

Composite rate of cardiac death and any MI, 3 years

Composite rate of all death and any MI

Composite rate of all death, any MI, and any repeat revascularization

Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy

Eligibility Criteria:
Inclusion Criteria:

* The patient agrees to participate in this study by signing the informed consent form.

Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form

Exclusion Criteria:

* There are no exclusion criteria for this registry.
Multi-Treatment PNN Modulation for Chronic Rhinitis

Feasibility of treatment at multiple sites with the ClariFix cryoablation device for treatment of chronic rhinitis


Eligibility Criteria:
Inclusion Criteria:

* Presence of moderate to severe rhinorrhea symptoms and mild to severe nasal congestion symptoms for \>3 months.
* Documented allergy test within the last 10 years that defines whether or not subject has allergies to perennial and seasonal allergens, or is willing to have one performed prior to study exit.
* Able to provide informed consent and willing to complete study activities and visits per protocol.

Exclusion Criteria:

* Clinically significant anatomic obstructions that limit access to the posterior nose.
* Prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose.
* Moderate to severe ocular symptoms as determined.
* History of epistaxis in the past 3 months.
* History of rhinitis medicamentosa.
* Prior head or neck irradiation.
* Active or chronic nasal or sinus infection.
* Pregnant.
* Allergy or intolerance to anesthetic agent.
* Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and/or, open and/or infected wounds at or near the target tissue.
* Currently participating in another clinical research study.
* Any physical condition that, in the investigator's opinion, would prevent adequate study participation or pose increased risk.
Detection of Mycoplasma Pneumoniae

The objective of this Clinical Trial is to define the methods to be used to document that illumigene® Mycoplasma Direct meets its intended use claims, using the illumipro instrument, with throat swab samples collected from symptomatic patients.


Eligibility Criteria:
Inclusion Criteria:

* The subject has willingly given written informed consent.
* Specimens provided from subjects with symptoms of upper respiratory infections which may be attributable to Mycoplasma pneumoniae, or from patients suspected of having Mycoplasma pneumoniae.
* Dual throat swab collected per subject.

Exclusion Criteria:

* Subjects who are unwilling to sign the written informed consent.
* Multiple sets of specimens collected from the same subject.
* Subjects who are unwilling or unable to provide the required number of throat swabs.
Availability of Spine Neuronavigation in Africa

In this study, the availability of spine neuronavigation in Africa was evaluated. Access to surgical equipment is an important goal of global surgery and global neurosurgery. The study findings show that there are regional differences in access to spine neuronavigation techniques and highlight that the major barriers to increased prevalence are cost and lack of trained personnel.


Eligibility Criteria:
Inclusion Criteria:

* Neurological and orthopedic surgery residents, fellows and consultants working in Africa.

Exclusion Criteria:

-
Evaluation of a Smartphone Intervention to Reduce Sedentary Behavior

Participants (N = 300) will be randomly assigned to: 1) an equipment-only comparison group that receives a smartphone and an activity monitor wristband but does not receive smartphone intervention prompts, or 2) the intervention group who will receive an activity monitor wristband that works in conjunction with a smartphone to reduce sedentary time via smartphone prompts during prolonged sedentary bouts. All participants will be provided with a Fitbit® wristband activity monitor and an Android smartphone on the same day of the week (i.e., Mondays). Participants will complete a 1-week baseline accelerometer and EMA period prior to the start of the intervention. Participants will be followed for 26 weeks after the intervention begins with follow-up visits at 6, 13, and 26 weeks. The primary outcome will be accelerometer-measured time spent in sedentary activity. Sedentary breaks, total active time, and time spent in light, moderate, and vigorous activity will be additionally evaluated as outcomes. Contextual variables and potential treatment mechanisms will be assessed via traditional questionnaire measurement and daily random EMAs at baseline and all follow-up visits. Brief smartphone-based daily diary assessments will be completed daily for the duration of the study.


Eligibility Criteria:
Inclusion Criteria:

* A score of ≥ 4 on the REALM-SF85 indicating \> 6th grade English literacy level, must be at least 18 years of age
* A BMI ≥ 25 (overweight/obese), not meeting current physical activity guidelines as measured by the 7-Day Physical Activity Recall
* Do not have a contraindication for physical activity based on the Physical Activity Readiness Questionnaire (PAR-Q)
* Able to attend all study visits, and possess a valid home address and a functioning telephone number.

Exclusion Criteria:

* Participants who have physical disabilities that restrict lower limb function and/or reading skills below a 7th grade reading level.
Predictors of Post Operative Morbidity in Older Women With Pelvic Organ Prolapse

The Investigators hypothesize that functional status scores in elderly women undergoing surgery for pelvic organ prolapse will be lower at 6 weeks post-operatively but will have returned to baseline at 12 weeks post-operatively.

The Investigators hypothesize that greater co-morbidity, frailty and worse functional status before surgery are associated with slower functional recovery, prolonged length of stay in a hospital or nursing care institution and greater post-operative complications following surgery for pelvic organ prolapse.

An increasing number of elderly women are undergoing surgical treatment for pelvic organ prolapse (POP). Based on US Census data1 and the estimated prevalence of pelvic organ prolapse in women 60 and over, an estimated 1.6 million women over 60 are currently affected with pelvic organ prolapse (POP). This number is expected to increase to 3.4 million by 2050. Prior studies show that geriatric patients have unique physiologic vulnerability, and elderly women undergoing surgery are at risk for worse post-operative outcomes than younger women. However, data from the urogynecology literature are conflicting. Some studies show an increased risk for complications as women age while other studies show no significant increased risk. Other evidence suggests that elderly women still are below their baseline quality-of-life status 6 weeks post-operatively. Return to baseline functional status at 6 weeks post-operatively was not improved when these women were randomized to enhanced pre-operative geriatric assessment versus routine care. These studies were limited by low numbers of very old women and women undergoing obliterative surgery, usually recommended for women with higher co-morbidities and lower functional status.

Post-operative outcomes have been traditionally measured in terms of medically documented complications such as infection, organ injury, cardiac and pulmonary complications. However, studies from other surgical specialties suggest that older subjects undergoing surgery can suffer from significant worsening of functional status resulting in disability, need for long-term care, and dependency at home. Objective markers of functional status, co-morbidity and frailty are potential useful predictors of post-operative complications following surgery in the elderly. However, there is lack of data on the functional status of elderly women undergoing POP surgery, as well as on factors influencing recovery from surgery. The goal of our study is to explore the utility of pre-operative markers of functional status, co-morbidities and frailty to explain post-operative morbidities in elderly women undergoing surgical treatment for pelvic organ prolapse.

Eligibility Criteria:
Inclusion Criteria:

* Women over age 60 undergoing either reconstructive or obliterative surgery (for Stage 2 or greater POP 2) English speaking

Exclusion Criteria:

* Women under the age of 60 will be excluded.
Randomized Trial of Interventions to Improve Warfarin Adherence

The purpose of this research study is to see if a lottery which provides the opportunity to win money, a reminder system using a "Med-eMonitor", or the combination of both might be useful in helping patients to achieve better control of their anticoagulation therapy. Selection for the arms of the study is randomized by the study computer. Some will participate in the daily lottery only, some with the reminder system only, some with the reminder system and the daily lottery, and some with neither the lottery nor the reminder system.

Eligible subjects will be enrolled in one of the 4 arms of the RCT and followed for 6 months, with the primary outcome of out-of-range INRs. Subjects will be given a Med-eMonitor to connect to their home phone line. For all subjects, these will be used to measure daily adherence. Subjects in the incentive group will be eligible for a daily lottery prize only if, prior to the lottery being resolved, their adherence device has registered adherence to their prescribed warfarin regimen. Subjects in the MM group will have the reminder/feedback features of the Med-eMonitor turned on to provide reminders to take their warfarin as prescribed and standardized messages that will be used to provide feedback in response to their adherence. Subjects in the combined group will be exposed to both the lottery and the activated Med-eMonitor. This trial is a randomized controlled trial.

Both men and women who are at least 18 years of age and have been prescribed anticoagulation medication are eligible to participate.

Eligibility Criteria:
Key Inclusion Criteria

The study population will include all patients at the study sites who:

1. are in the maintenance phase of their warfarin treatment (defined using the standard method as the period of time following 2 consecutive visits, at least 7 days apart, of stable target INR after initiation of the drug)
2. whose providers indicate are expected to stay on treatment for at least 6 months
3. have a target INR of 2 to 3.5
4. had at least one INR out of the participant's target range within 90 days prior to enrollment (excluding the baseline visit) and/or INR at the baseline visit was below the participant's target range
5. have a working analog telephone line.

Of note, patients do not have to be within their target INR range to enroll; we specifically want to include those who are below the target range at the time of study entry because they may be the patients most likely to be non-adherent.

Key Exclusion Criteria Patients will be excluded if they do not meet the above inclusion criteria,

1. have an INR at screening above the target range
2. are less than 18 years of age and cannot or will not give consent
3. cannot read above a 6th grade reading level
4. are enrolled in a clinical trial of warfarin therapy
5. are unable to adequately follow study procedures