cyrilzakka/clinical-trials huggingface dataset:
Text Reminders for Immunization Compliance in Kids (TRICKS) Pilot Study

As a participant in these research program you will be a parent of a child born at Wesley Medical Center who plan to use Carriage Park Pediatric Clinic for your child's care. Mobile phone text messages will be sent to remind you of your child's immunizations.

The long term research goal is to increase childhood immunization rates by improving parental health literacy through an innovative text messaging system regarding immunization schedules for children under the age of six.


Eligibility Criteria:
Inclusion Criteria:

* parent or caregiver of a well child born at Wesley Medical Center;
* planning to utilize the Carriage Park Pediatric Clinic for his/her child's medical home; (
* adult (\> 18 years of age);
* present use of a mobile phone for sending and receiving text messages;
* English or Spanish speaking;
* able to provide informed consent.

Exclusion criteria include:

* personal or religious beliefs against immunizations;
* inability to complete enrollment information.
A Non-inferiority, Multicenter and Randomized, Multiple-Dose Study About a Treatment to Hypolactasia

The primary objective is to determine the compared clinical efficacy of Lactase Eurofarma (test drug), showing non-inferiority to Lactaid® (comparative drug) in the supportive treatment of lactose intolerance and to assess the safety and tolerance of Lactase Eurofarma (test drug) in the supportive treatment of lactose intolerance.


Eligibility Criteria:
Inclusion Criteria:

* To have participated in the single-dose clinical study (EF099) previously performed, with the clinical response being considered as satisfactory by the investigator
* The patient should be a male or female, aged between 18 and 60 years old
* Have a medical history consistent with lactose intolerance, confirmed by the test of hydrogen in the expired air
* The female patients should agree to use birth control methods during the study participation
* To be able to meet the study instructions and all the visits required
* To give a free consent to participate in the study and sign the informed consent form (ICF).

Exclusion Criteria:

* Smoking
* Secondary hypolactasia
* Gastrointestinal inflammatories diseases - present diverticular disease, diabetic gastropathy or neoplasias
* Colonoscopy or colon cleaning procedure 4 weeks before the start of study
* Latrogenic: unnoticed intake of laxatives in over-the-counter drugs or alternative medicine, intake of cereal bran or probiotics
* Diagnosis of HIV, immunodepression of any origin, or cancer under treatment.
* Diagnosis of other comorbidity that, at the investigator's discretion, may compromise the study participation (e.g., systemic infection during the study or use of antibiotics in the last 4 weeks, diabetes mellitus, uncontrolled hypertension or renal failure),
* Hypersensitivity or previous laboratory or clinical adverse event related to the use of lactase or any of the components of the formulations used in the study
* Incapacity to understand and complete the study questionnaires, including the questions that require the use of the Visual Analogue Scale and ICF
* Pregnancy or lactation
* Use of alcohol, exceeding 3 doses daily
* Participation in another clinical study on the last 12 months
* Patient having some chronic pulmonary disease that, in the investigator's opinion, may harm or interfere with the expired hydrogen test (e.g., cystic fibrosis).
Essen Coronary Artery Disease Registry

The ECAD registry is a registry of patients undergoing coronary angiography at the West German Heart and Vascular Center. The registry anticipates to determine predictors of patient outcome after coronary angiography.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing invasive coronary angiography at the West German Heart and Vascular Center

Exclusion Criteria:

* None
Effect of Global Postural Correction Exercises on Stress Urinary Incontinence During Pregnancy: A Randomized Controlled Trial

Background: One of the many consequences of pregnancy that may negatively affect a woman's quality of life is stress urinary incontinence caused by activities of daily living especially those associated with increased intraabdominal pressure. Objective: This study aimed to investigate the effect of global postural correction exercises on stress urinary incontinence among pregnant women. Participants and Methods: Forty primigravida women (aged between 30-39 years), with a single fetus, diagnosed with stress urinary incontinence participated in the study. Participants were assigned randomly into two groups: Study group (group A; n=20) and control group (group B; n=20). The participants were tested twice, before and after a 12-week period, during which group A received global postural correction exercises in addition to Kegel exercises, while group B performed only Kegel exercises. A perineometer was used to evaluate the change in vaginal squeeze pressure both before and after conducting the study. Urogenital Distress Inventory Questionnaire (UDI-6) was used to assess changes in incontinence severity symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Forty primigravida women with singleton fetus in their third trimester and diagnosed with pregnancy related SUI participated in this study.

All participants suffered from a mild to moderate grade of SUI identified by clinical grading (Ingelman-Sundberg) (Wlazlak et al., 2015) as follows: Grade I (mild), the leakage of urine occurs on straining; and grade II (moderate), the leakage occurs following abrupt movement

Exclusion Criteria:

* Females were excluded from the study if they had severe grade SUI; infections in their lower urinary tract; neurological conditions; gestational diabetes; and chronic chest diseases. Females who smoked, used any medications or medical/surgical interventions for SUI, or who suffered any other type of urinary incontinence were also excluded from the study
Efficacy and Safety Study of OSI-211 (Liposomal Lurtotecan) to Treat Recurrent Small Cell Lung Cancer

The purpose of this study is to determine whether OSI-211 (Liposomal Lurtotecan) is an effective and safe treatment for patients with recurrent small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed recurrent small cell lung cancer.
* One prior treatment of chemotherapy.
* At least three weeks since last chemotherapy treatment and recovery from any related side effects.
* At least three weeks since last chest radiotherapy and at least 10 days since head irradiation and recovery from acute side effects.
* At least one target tumor less than or equal to 20 mm (or less than or equal to 10 mm on spiral CT-scan).
* If a patient has had previous documented Central Nervous System (CNS) involvement, only controlled disease is acceptable.

Exclusion Criteria:

* Superior vena cava syndrome.
Elastic Band Resistance Training on Physical Fitness and Risk of Falls in Elderly.

A lack of studies has applied elastic band resistance training exercises on hospitalized elderly, so the effect of elastic band resistance training exercises on physical fitness and risk of falls was unclear. Therefore, the purposes of this study were to investigate the effectiveness of elastic band resistance training on improving physical fitness and reducing the risk of falls in hospitalized elderly with high risk of falls. This study is an experimental study. The experimental group was given 3 times a week for 2 consecutive weeks of elastic band resistance training, while the control group was given regular rehabilitation exercises. The differences in physical fitness and fall risk between the two groups were examined.


Eligibility Criteria:
Inclusion Criteria:

1. Elders are over 65 years old and admitted to this medical ward due to acute/chronic disease
2. Elders have no physical impairment
3. Elders have a clear cognition, can follow movement commands in Chinese or Taiwanese
4. Elders have greater than 4 points in lower extremity muscle strength measured by the Manual Muscle Power Test
5. Elders have greater than 45 points in the Morse Fall Scale, which indicate a high risk of falling

Exclusion Criteria:

1. Unclear consciousness
2. Unable to follow the execution of elastic band resistance training
3. With restricted activities, musculoskeletal disorders, or nerve diseases
4. Unsuitable athletic trainers
Supplementary Motor Area is a Potential Target for Speech Disturbance in Parkinson Disease

Speech disturbance is common in patients with Parkinson disease. Pharmacotherapy improves motor symptoms but has inconsistent effects on speech disturbance in PD patients. Transcranial magnetic stimulation (TMS) is a safe and non-invasive tool used for brain stimulation. Repetitive transcranial magnetic stimulation (rTMS) has positive effects on motor function of PD. Yet, its effect on speech disturbance seems to be inconclusive. Previous rTMS studies mainly focused on the primary motor cortex for PD speech disturbance. Nevertheless, we think supplementary motor area (SMA) may be a better target. Speech disturbance in PD may be associated with basal ganglia-thalamocortical motor circuits and SMA involves in the cortex part. In addition, neuroimaging studies showed that SMA were under-activation in PD patients. Therefore, we conduct this 3-year study including two experiments. The aim of the study is to determine if rTMS over SMA can improve the speech function of PD patients and change the functional connectivity of speech pathway in the brain. This will be the first study to investigate the effect of rTMS over SMA on speech.


Eligibility Criteria:
Experiment 1

Inclusion Criteria:

* right-handed healthy adult volunteers who understand and agree on the informed consent of the study

Exclusion Criteria:

* pregnancy or possibility of pregnancy
* history of seizure
* family history of epilepsy
* metals in any part of the body.

Experiment 2

Inclusion Criteria:

* PD patients with speech disturbance who understand and agree on the informed consent of the study. The speech item scored 2 or 3 in the unified Parkinson's disease rating scale (UPDRS) part III.

Exclusion Criteria:

* dementia
* the history of stroke, brain lesion, other central nervous system diseases
* the contraindication of TMS which described above
* any contraindication of MRI
Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens

The objective of this study is to evaluate clinical outcomes following sub-2 mm micro-incision cataract surgery (MICS) and intraocular lens (IOL) implantation. This study is evaluated in two Phases

* V4 (6M) endpoint: primary analysis
* V5 (12M) and V6 (34M): EPCO score and Nd Yag incidence analysis


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have clear intraocular media other than cataract in the study eye.
* Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with micro-incision phacoemulsification cataract extraction in the study eye.

Exclusion Criteria:

* Subjects with ocular malformation in the study eye.
* Subjects who have had previous surgery in the study eye.
* Subjects with uncontrolled glaucoma in either eye.
* Subjects with any anterior segment pathology for which micro-incision phacoemulsification cataract surgery would be contraindicated
* Subjects using medications known to potentially complicate cataract surgery.
Multidimensional Accurate Diagnosis and Treatment Technology and Clinical Transformation of Type 2 Diabetes Nephropathy

Diabetes nephropathy (DN) is one of the most serious microvascular complications of diabetes, and also an important cause of death and disability of diabetes patients. There is no specific clinical staging of type 2 diabetes nephropathy at home and abroad, and there is no comprehensive study to comprehensively describe the occurrence and development of type 2 diabetes nephropathy through sensitive biomarkers, microvascular disease imaging and functional detection, digital markers and other multi-dimensional diagnosis and evaluation methods. Therefore, our research aims to establish a long-term follow-up queue for the whole cycle of diabetes nephropathy, develop multi-dimensional diagnostic and progress digital markers for diabetes nephropathy, develop a multimodal non-invasive diagnostic model and a new clinical staging/typing, and create a multi-dimensional accurate diagnosis and treatment system for type 2 diabetes nephropathy combining traditional Chinese and western medicine.


Eligibility Criteria:
Inclusion Criteria:

Age ≥ 18 years old, regardless of gender; Type 2 diabetes; Having a complete medical history and clinical data; If the patients with type 2 diabetes combined with CKD underwent renal biopsy, the pathological diagnosis should be clear; Patients voluntarily signs an informed consent form.

Exclusion criteria:

Incomplete medical history or clinical data; Patients with hereditary kidney disease; Combined urinary tract infection; Merge autoimmune system diseases; Patients with malignant tumor were expected to survive less than 6 months; Pregnancy and lactation.
Pharmacokinetics of Carnosine

The absorption kinetics of dietary carnosine (β-alanyl-L-histidine) will be determined in the healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult
* normal hematological parameters, normal serum albumin, normal liver function, normal kidney function

Exclusion Criteria:

* History of smoking or alcoholism
Surgery in Treating Patients With Prostate Cancer

RATIONALE: Prostatectomy may be an effective treatment for prostate cancer that has not responded to radiation therapy.

PURPOSE: This phase II trial is studying how well prostatectomy works in treating patients with recurrent or persistent prostate cancer that has not responded to radiation therapy.

OBJECTIVES:

* Determine the characteristics of failure-free survival, disease-free survival, overall survival, surgical morbidity and mortality, and quality of life of patients treated with salvage prostatectomy for the recurrence of persistent disease after treatment with prior radiotherapy for localized prostate cancer.
* Develop expertise in the use of salvage prostatectomy prior to a possible phase III trial of salvage prostatectomy in this population versus a control arm such as hormonal therapy or cryotherapy.
* Determine the quality of life measures in these patients.
* Determine the preliminary data on the quality of life of patients undergoing salvage radical prostatectomy and use the data to design a phase III study.
* Determine the histologic and morphometric characterization of the carcinoma.

OUTLINE: Patients undergo modified bilateral pelvic lymph node dissection.

Patients with negative nodes undergo salvage prostatectomy via either retropubic or perineal approach. Patients with positive nodes may undergo radical prostatectomy at the discretion of the investigator.

Postoperative hormonal therapy may be given at time of symptomatic disease progression or a newly positive bone scan, or for a consistently rising prostate-specific antigen. Adjuvant hormonal therapy is also allowed.

Quality of life is assessed prior to surgery and at 3, 6, 12, 18, and 24 months after surgery.

Patients are followed at least every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven recurrent or persistent prostate cancer
* Prostate-specific antigen (PSA) no greater than 20 ng/mL
* Must have been previously treated with at least 60 cGy of external beam radiotherapy or brachytherapy for clinical stages T1-2NXM0 with PSA no greater than 30 ng/mL
* No metastatic disease at time of biopsy

PATIENT CHARACTERISTICS:

Age:

* 75 and under

Performance status:

* CALGB (Zubrod) 0-1

Life expectancy:

* At least 5-10 years

Other:

* No other "currently Temporarily closed" malignancy except nonmelanoma skin cancer

  * Patients are not considered to have a "currently Temporarily closed" malignancy if they have completed therapy and are considered to be at less than 30% risk of relapse

PRIOR CONCURRENT THERAPY:

Endocrine therapy:

* At least 3 months since prior adjuvant hormonal therapy

Radiotherapy:

* See Disease Characteristics
* At least 18 months since prior external beam or interstitial radiotherapy
A Clinical Comparison in Cervical Epidural Pressure Changes Between Midline and Paramedian Approaches

Ligamentum flavum in the cervical region is thin or not fused at the midline. The investigators inferred that the size and elasticity of the ligamentum flavum, in combination with mildline appraoch, the gaps could be responsible for a failure to recognize a LOR in some patients. If so, the investigators hypothesized that the paramedian approach would be advantageous for finding cervical epidural space more easily during cervical epidural steroid injections (CESIs).

Ligamentum flavum in the cervical region is thin or not fused at the midline. The distinct elastic resistance offered by the ligamentum flavum before entering the epidural space when using the loss of resistance (LOR) technique may be blunted or even absent. The investigators inferred that the size and elasticity of the ligamentum flavum, in combination with mildline appraoch, the gaps could be responsible for a failure to recognize a LOR in some patients. If so, the investigators hypothesized that the paramedian approach would be advantageous for finding cervical epidural space more easily during cervical epidural steroid injections (CESIs). Therefore, the investigators randomly divide our patients into 2 groups; the midline approach group and the paramedian group. Then, the investigators examine the patterns of the pressure changes at the moment of a puncture of the ligamentum flavum during CESIs.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 80 yr
* Cervical radicular pain caused by herniated nucleus pulposus, spinal steonosis, or other conditions, including herpes zoster-associated pain and whiplash injury for more than 3 months
* Pain intensity \> 4 of maximum 10 NRS
* Failure to improve with conservative treatment
* Cervical epidural location of needle confirmed by the fluoroscopic images

Exclusion Criteria:

* Acute infection
* Patient refusal
* Previous cervical spine surgery
* Structural spinal deformities or A space-occupying epidural mass
* Rapidly worsening pain, numbness, weakness, hyperreflexia, changes in bladder function, and other neurological symptoms that should prompt a reevaluation and surgical evaluation
* Pregnancy
* Allergy to contrast media or drugs to be used in the procedure
Eliquis (VTE Treatment and Prevention of Recurrent VTE) rPMS

To assess the real-world safety/effectiveness of Eliquis in Korean venous thromboembolism (VTE) patients and patient characteristics that are associated with bleeding among patients taking Eliquis. To identify factors that might be associated with the safety and effectiveness profile in Korean VTE patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥19 years of age) patients who are initiating treatment with Eliquis for the treatment of VTE or prevention of recurrent VTE for the first time in accordance with the Korean package insert will be enrolled in the study

Exclusion Criteria:

* Patients with prior treatment with Eliquis before enrollment in this study
* Patients receiving Eliquis treatment for an indication not approved indication in Korea
* Patients meeting any of the following criteria will not be included in the study:

  i) Hypersensitivity to the active substance or to any of the excipients

ii) Clinically significant active bleeding

iii) Hepatic disease associated with coagulopathy and clinically relevant bleeding risk

iv) Patients with increased bleeding risk due to such as following diseases:

1. Recent gastrointestinal ulceration history
2. Recent intracranial or intracerebral haemorrhage history
3. Intraspinal or intracerebral vascular abnormalities
4. Recent brain, spinal or ophthalmic surgery history
5. Recent brain or spinal injury
6. Known or suspected oesophageal varices
7. Arteriovenous malformations
8. Vascular aneurysms
9. Patients with malignant neoplasms at high risk of bleeding

   * Concomitant treatment with any other anticoagulant agent:

i) Unfractionated heparin (UFH)

ii) Low molecular weight heparins (enoxaparin, dalteparin, etc)

iii) Heparin derivatives (fondaparinux, etc)

iv) oral anticoagulants (warfarin, rivaroxaban, dabigatran, etc) except under the circumstances of switching therapy to or from apixaban or when UFH is given at doses necessary to maintain a patent central venous or arterial catheter

* Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption
Effects of Shotblocker and Manual Pressure on Pain and Satisfaction

This study aims to determine the effects of shotblocker and manual pressure applied during peripheral venous catheter placement on pain and satisfaction. 81 patients hospitalized in the Urology clinic will be included in the study. Patients will be assigned to three groups as shotblocker (n=27), manual pressure (n=27) and control group (n=27) by block randomization method.

Research Hypotheses

* H1-1: The mean pain scores of the intervention group to which shotblocker was applied during peripheral intravenous catheterization are different from the control group.
* H1-2: The mean pain scores of the intervention group to which manual pressure was applied during peripheral intravenous catheterization are different from the control group.
* H1-3: The mean satisfaction scores of the intervention group to which shotblocker was applied during peripheral intravenous catheterization are different from the control group.
* H1-4: The mean satisfaction scores of the intervention group to which manual pressure was applied during peripheral intravenous catheterization are different from the control group.


Eligibility Criteria:
Inclusion Criteria:

* Admission to the urology clinic,
* No verbal, perceptual and visual communication problems,
* Between the ages of 18 and 65,
* Literate,
* Volunteer to participate in the study,
* Not using medication that will create a chronic analgesic effect,
* Not having chronic or acute pain,
* No intervention has been performed on the vein where the PIC is placed in the last month,
* No scar tissue or infection in the areas where the PIC will be placed,
* Not having a disease that will cause problems in feeling pain (such as neuropathy)

Exclusion Criteria:

* The individual wants to leave the study,
* Feels unwell during the PIC placement (such as dizziness, palpitations),
* Uses sedatives or alcohol,