cyrilzakka/clinical-trials huggingface dataset:
Stereotactic Pelvic Adjuvant Radiation TherApy in Cancers of the UteruS

Advanced technology has enabled radiation oncologists to more accurately and precisely target radiation to areas at risk while maximally sparing healthy tissue. A secondary result of these technologic advances has been the increased utilization of hypofractionationed treatment protocols, since the combined ability to better visualize and precisely deliver radiation to target volumes has allowed radiation oncologists to leverage the therapeutic ratio toward higher target doses whilst maintaining safe doses to the pertinent organs-at-risk. The spectrum of hypofractionation ranges from what are considered moderate (ie. 2- 5 Gy / fraction) into the realm of what is more commonly referred to as stereotactic body (SBRT), generally \>5 Gy / fraction. There is growing evidence demonstrating both safety and efficacy for SBRT. The investigators propose that these advantages are translatable to the adjuvant treatment of endometrial cancer.

The investigators submit that a prescription dose of 30 Gy in 5 fractions. Through precision delivery and careful dosimetry the treatment should be safe and well tolerated with minimal impact on patient quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed endometrial adenocarcinoma
* Patient is a candidate for adjuvant pelvic radiation (+/- vault brachytherapy), meeting one of the following conditions:

  * Patient has serous, clear cell, carcinosarcoma or differentiated histologies.
  * Outer-half myometrial invasion and FIGO grade 1-2 OR
  * FIGO stage II - IIIC1.
* Willing and able to give informed consent to participate in this clinical trial.
* Age ≥18 years.
* Are to receive adjuvant systemic therapy in addition to pelvic radiotherapy will be eligible provided that there is at minimum a 3-week interval between any radiation treatment and chemotherapy treatments.
* Willing and able to complete the QLQ-C30 questionnaire with EN-24 companion as described in the study protocol.
* Primary language of the patient must be English or, if a patient's primary language is not English, they are still able to participate provided the QLQ-C30 and EN-24 is available in their primary language.

Exclusion Criteria:

* Has had prior pelvic radiotherapy.
* Has a contraindication to pelvic radiotherapy, such as but not limited to a connective tissue disease or inflammatory bowel disease.
* Has a contraindication to iodinated CT contrast.
* Has a hip prosthesis.
360 Degree Expanded Diaphragm Breathing Pattern Training in Individuals With Urinary Incontinence

The aim of this study is to investigate the effect of transferring the healthy intra-abdominal pressure created by 360 degree expanded diaphragm breathing taught to the patient to the pelvic cavity on incontinence problems.

66 people with a score of 3 or higher on the Incontinence Severity Index will be included in the study. All participants will complete the King Health Questionnaire and Incontinence Quality of Life Questionnaires. The control group will consist of 33 people and will apply only Kegel exercises 2 sets a day, 3 days a week for 8 weeks. The experimental group will consist of 33 people and the participants will apply Kegel exercises for 8 weeks, 3 days a week, 2 sets a day. In addition to this, 360 degree expanded diaphragm breathing training will be given to the experimental group. Practices for using this breathing pattern will be done 2 sets per day, each set for 10 minutes. At the end of 8 weeks, all 3 questionnaires will be asked to be filled again. The variation between the initial results and the final results, as well as the differences between the final changes, will also be compared.

Eligibility Criteria:
Inclusion Criteria:

* Getting a score of 3 and above in the incontinence severity index.
* Be in the age range of 12-65 years.
* No neurological problems.

Exclusion Criteria:

• Having a history of surgery or childbirth in the last 3 months.
The Association of Cigarette Smoking on Exercise Capacity and Skeletal Muscle Function in Taiwan Adult Smokers

Background and purpose: Cigarette smoking would post threats to physical health. Even though studies suggested that long-term cigarette smoking would lead to cardiovascular diseases, pulmonary diseases, or even cancer development, the smoking population all around the world was still common. Before progressing into the disease stage, cigarette smokers might have presented decreasing exercise capacity, skeletal muscle function, and cardiac autonomic function as early signs of physiological function decline. The purposes of this study are (1) to investigate the difference in exercise capacity, skeletal muscle function, and cardiac autonomic function between smokers and never smokers, and (2) to test the hypothesis that cigarette smoking is an independent factor associated with exercise capacity.

Methods: This is a cross-sectional observational study. This study will invite 150 participants from community in Taipei City. The body composition will be analyzed by bioelectrical impedance analysis, and resting heart rate variability will be evaluated by the heart rate variability monitor. Besides, grip strength, exhale carbon monoxide concentration, pulmonary function test, respiratory muscle performance will be measured. Moreover, subject will have to fill up the Fagerström Test for Nicotine Dependence and Seven-Day Physical Activity Recall Questionnaire. Last will be the cardiopulmonary exercise testing. Statistical analyses will be performed by statistical software for social sciences (SPSS) statistical package v.21.0 for Windows. (IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp.) Between-group comparisons of exercise capacity, skeletal muscle function and heart rate variability parameters will be performed using independent Student's t-test. Pearson's correlation coefficient will be used to test the correlations between outcome parameters. Stepwise regression analysis will be used to examine the independent association between smoking and exercise capacity after controlling for confounders. The α level will be set at 0.05. The results of this study would provide the early effects of cigarette smoking on physical function, and highlight the importance of early detection and intervention.


Eligibility Criteria:
Inclusion Criteria:

* male 20 ≤ age ≤ 45 years old
* female 20 ≤ age ≤ 55 years old
* age and gender-matched non-smokers

Exclusion Criteria:

* uncontrolled cardiovascular diseases, neurological diseases, musculoskeletal system problems, or systemic diseases that contraindicate the exercise
* women in pregnancy or menopausal women
* any ongoing medication that has a documented effect on the autonomic nervous system (e.g., tricyclic anti-depressants)
* has been diagnosed with autonomic nervous system disorders
Artemether/Lumefantrine and Vivax Malaria

The cure rate of artemether/lumefantrine in the treatment of vivax malaria.


Eligibility Criteria:
Inclusion Criteria:

* Patients with vivax malaria

Exclusion Criteria:

* severe malaria
* pregnancy
Wide-field Optical Coherence Tomography Imaging of Excised Breast Tissue.

This is a single-arm, multi-center data collection study designed to collect WF-OCT imaging data of excised breast tissue margins with corresponding margin status from histopathology.

Data collected during this study will be used for product development by the study sponsor, Perimeter Medical Imaging.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 18 years or older
* Invasive ductal breast carcinoma and ductal carcinoma in situ having undergone breast conservation surgery
* May include neo-adjuvant treated subjects (chemotherapeutic, endocrine therapy, or radiation)
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Metastatic cancer (Stage IV)
* Lobular carcinoma as primary diagnosis
Assessment of Potential Interactions Between Cocaine and RPR 102681 - 1

The purpose of this study is to assess Potential Interactions Between iv Cocaine and RPR 102681

Phase I, Double-Blind, Placebo-Controlled Dose Escalating Assessment of Potential Interactions Between Intravenous Cocaine and RPR 102681

Eligibility Criteria:
Inclusion Criteria:

Includes but is not limited to:

* Non-treatment seekers
* DSM-IV criteria for cocaine abuse or dependence
* Ability to verbalize understanding of consent form and provide written informed consent and verbalize willingness to complete study procedures; be able to comply with protocol requirements

Exclusion Criteria:

Please contact site for more information.
Pilot Study: a Telehealth Intervention for Caregivers of Infants with Early Signs of ADHD

This project will build on the investigators' work focused on early identification of ADHD, expanding to the development of a feasibility/pilot intervention involving early intervention for such infants. The investigators will evaluate the effectiveness of a telehealth-delivered, caregiver-implemented supportive intervention for infants/toddlers show early self-regulation difficulties.

This project will build on the investigators' work focused on early identification of ADHD, expanding to the development of a feasibility/pilot intervention involving early intervention for such infants. The investigators will evaluate the effectiveness of a telehealth-delivered, caregiver-implemented supportive intervention for infants/toddlers show early self-regulation difficulties.

Primary aims of this study include:

1. Develop and test a telehealth-delivered, parent-mediated intervention targeting infant/toddler self-regulation in natural contexts, to aid both infant and caregiver learning.
2. Identify, develop, and test measures/observations that can be gathered via telehealth contacts to assess ongoing change in infant and caregiver behavior over the course of the study.
3. Test acceptability and satisfaction of the intervention and the telehealth delivery for families receiving the intervention.

Eligibility Criteria:
Inclusion Critera:

Infants must be enrolled in UC Davis IRB protocol #1077801 and

* Be between the ages of 12-18 months at the time of intake assessment,
* Have a first-degree relative with ADHD (parent or sibling),
* Exhibit early symptoms of ADHD based on examiner observation as indicated by at least 1 subscale on the Behavior Rating Inventory for Children (BRIC) rated 4 or higher,
* Expression of at least 1 concern about the child's behavior/development by the caregiver.

Caregivers must:

* Be identified as the infants' primary caregivers,
* Be English-speaking,
* Have access to wired or wireless network technology to access the internet in their homes.

Exclusion Criteria:

* Birth before 33 weeks' gestation,
* Known genetic disorders (e.g., fragile X syndrome, Tuberous Sclerosis),
* History of traumatic brain injury,
* Severe visual, hearing, or motor impairment or fragile health condition that would prevent the child from validly participating in the assessment procedures, and
* A caregiver may be excluded from participation if the caregiver is already engaging in the majority of all possible caregiver treatment target behaviors at therapeutic levels during intake (Fidelity of Implementation scores of 80% or higher on each caregiver target behavior).
Effect of Mulligan Medial/Lateral Glide w/wo Compression/Decompression Technique on Pain ROM and Function KO

The Effect of Mulligan Medial/Lateral Glide Techniques with and without Compression-Decompression on Pain, Range of Motion and Function in Patients with Knee Osteoarthritis. This study aims to investigate these effects to develop more effective, non-invasive treatment protocols for improving pain, range of motion and overall function in knee OA

patients, for the better understanding of response by both treatments (i.e Mulligan medial/lateral glide with and without compression/decompression technique). Patient which meet inclusion criteria, gave their consent.

Eligibility Criteria:
Inclusion Criteria

* Unilateral Knee OA, Males and females between 30 and 60 years of age,
* Patients with restricted ROM,
* Patients are having more than grade III strength of knee muscles,
* l Willingness to take part in the intervention and evaluations

Exclusion Criteria:

* Patients having unstable knee joint after Total Knee Arthroplasty or medical conditions affecting rehabilitation,
* l Joint infection of hip and knee,
* l Soft tissue injuries around knee joints,
* including tendinitis and bursitis,
* l Any fracture including patellar fracture, femur or tibia
CBT-I for Psychosis: Guidelines, Preliminary Efficacy, and Functional Outcomes

The goal of this project is to develop guidelines for the clinical tailoring of Cognitive Behavioral Therapy for Insomnia (CBT-I) for Veterans with psychotic disorders and insomnia, and to test the acceptability, feasibility, and preliminary efficacy of CBT-I for improving sleep-related functional outcomes in this population.

The goal of this project is to develop guidelines for the clinical tailoring of Cognitive Behavioral Therapy for Insomnia (CBT-I) for Veterans with psychotic disorders and insomnia, and to test the acceptability, feasibility, and preliminary efficacy of CBT-I for improving sleep-related functional outcomes in this population.

Specific Aim 1: Develop empirically-derived guidelines for the clinical tailoring of CBT-I materials and procedures for Veterans with psychotic disorders through an iterative process with input from Veteran clients, CBT-I experts and providers, as well as those with expertise in psychotic disorders.

Specific Aim 2: Establish the acceptability of CBT-I for Veterans with psychotic disorders and insomnia when delivered using guidelines developed in Specific Aim 1 in order to make further refinements to the guidelines in a preliminary trial with 6 Veterans with psychosis and insomnia.

Specific Aim 3: Conduct a randomized controlled trial (n=60) to test the feasibility and preliminary efficacy of CBT-I in producing positive changes at post-treatment and 3-month follow-up on the outcomes of insomnia symptoms, sleep quality, and functioning.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnostic and Statistical Manual of Disorders, 5th edition (DSM 5) diagnosis of schizophrenic disorders (295.0-295.9), affective psychoses (296.0-296.1, 296.4-296.8), or major depression with psychotic features (296.24, 296.34).
2. Self-reported symptoms of insomnia via an Insomnia Severity Index (ISI) score of 15 or greater.
3. Age between 18 and 80 as determined by medical record review.
4. Participation in outpatient mental health services at a designated study site.
5. Sufficient clinical stability to participate as deemed by a treatment provider.
6. Capacity to sign Informed Consent.

Exclusion Criteria:

1. Current problematic drug or alcohol use that impacts functioning and study engagement, as deemed by a treatment provider.
2. Currently in CBT-I treatment, determined by medical records.
3. Positive screen for sleep apnea via a portable sleep apnea screening device or a prior diagnosis of sleep apnea in medical records.
Articaine 4% Efficacy and Safety in Extraction and Pulpotomy of Primary Molars of Children Below the Age of Four Years

compare the anaesthetic efficacy and safety for pain and behaviour for extraction or pulp therapy in primary molars in young children below four years old using 4% articaine and 2% lidocaine local anesthetics.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children
* 3-6 years
* primary molar indicated for pulpotomy
* body weight not less than 15 Kg

Exclusion Criteria:

* Intellectual problem
* sever emotional problems
* previous dental experience
* Medically or mentally compromised children
FlowTriever All-Comer Registry for Patient Safety and Hemodynamics

To evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE). The use of the device will be assessed in a real-world population, with eligibility criteria that closely approximate its use in clinical practice.

Up to 300 additional patients with anticoagulation treatment as the initial planned primary treatment strategy for intermediate risk PE will also be evaluated (US only).


Eligibility Criteria:
Inclusion Criteria:

* Clinical signs and symptoms consistent with acute PE
* Echo, CTPA or pulmonary angiographic evidence of proximal filling defect in at least one main or lobar pulmonary artery
* Scheduled for PE treatment with the FlowTriever System per the Investigator's discretion\*

  * US only: Patients enrolled in the Conservative Therapy Sub-study are not required to meet this inclusion criteria but must instead be scheduled for primary anticoagulation therapy as the primary treatment strategy.

Exclusion Criteria:

* Unable to be anticoagulated with heparin or alternative
* Diagnosis with a minor PE with a less than 0.9 RV/LV ratio
* Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated\*
* Imaging evidence or other evidence that suggests, in the Investigator's opinion, the subject is not appropriate for mechanical thrombectomy intervention\*
* Life expectancy \< 30 days, as determined by Investigator
* Current participation in another investigational drug or device treatment study that, in the Investigator's opinion, would interfere with participation in this study

  * US Only Patients enrolled in the Conservative Therapy Sub-study are not required to meet these exclusion criteria
Home-Based Fluid Status Monitoring in Heart Failure Patients

This is a prospective, multi-center, single-arm study enrolling adult patients who have been hospitalized for heart failure and subsequently discharged. For the duration of study participation, patients will obtain daily at-home bioimpedance measurements. Heart failure symptoms, medications, and re-hospitalizations will be tracked. Additionally, quality of life questionnaires will be administered at the beginning and end of study participation.


Eligibility Criteria:
Inclusion Criteria:

1. Age 21 years or older
2. NYHA Class II or III at the time of study enrollment
3. Undergoing discharge following hospitalization for acute heart failure
4. Planned continued treatment for heart failure
5. Patient is able to stand or sit upright for bioimpedance spectroscopy measurements
6. Patient reports access to reliable Wi-Fi connection at home
7. Patient reports adequate space for the SOZO device at home
8. Patient provides written informed consent and authorization to use and disclose health information, including willingness to comply with study procedures

Exclusion Criteria:

1. Patient has an implanted cardiac rhythm management device (pacemaker or implantable cardioverter defibrillator)
2. Patient has a confirmed diagnosis of acute coronary syndrome during current admission
3. Patient is enrolled in a concurrent interventional study of an experimental treatment that may confound the results of this study, in the investigator's opinion
4. Patient has a clinical condition that would not allow them to complete the study
5. Patient has had surgical revascularization using saphenous vein grafting that may affect venous return
6. Patient is pregnant or lactating
7. Patient has nephrotic syndrome or nephrosis
8. Patient has end-stage renal disease requiring chronic dialysis
9. Patient has been diagnosed with lymphedema
10. Patient has chronic liver failure or cirrhosis
11. Patient has been diagnosed with thrombophlebitis or deep vein thrombosis in arms or legs in the past 90 days
12. Patient has an amputation of a limb \[Exception: amputation of digits may not affect bioimpedance spectroscopy measurements and will be permitted at the discretion of the study sponsor\]
13. Patient has any other medical condition that, in the opinion of the investigator, will impair the subject's ability to complete study procedures or participate in the protocol
Observational Study of Patients Using NovoRapid® or Soluble Human Insulin for Treatment of Type 2 Diabetes

This trial is conducted in Europe. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes in patients with type 2 diabetes treated with NovoRapid® or Soluble Human Insulin under normal clinical practice conditions.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes
* Treatment with Insulin Aspart (NovoRapid®) or Soluble Human Insulin for minimum 3 months and maximum 3 years

Exclusion Criteria:

* Patients with an end-stage renal failure
* Patients with a serious liver disease
* Patients with concomitant malignant disease
Performance Proof of the New NORMA-SENSE

This study was designed to validate the color appearance on the newly developed panty liner (NORMA-SENSE). The NORMA-SENSE liner changes color when worn by the user and comes into contact with vaginal secretion with an elevated pH level, without false positives due to urine remains or incontinence. The study will also asses the physical comfort in using NORMA-SENSE and the result reading clarity which includes the ability to visualize and interpret the NORMA-SENSE strip results.


Eligibility Criteria:
Inclusion Criteria:

1. Women, age 18 years or greater without symptoms of vaginal infection.
2. Subject is ready to sign the informed consent form.

Exclusion Criteria:

1. Subject is unable or unwilling to cooperate with study procedures.
2. Subject is currently participating in another clinical study.
3. Subject suffers from vaginal bleeding or is menstruating.
4. Subject that have had sexual relations within the last 12 hours.
5. Subject that applied local antiseptic or antibiotic or vaginal treatment within the last 3 days.
6. Subject that applied vaginal douching within 12 hours prior to the visit at the clinic.