cyrilzakka/clinical-trials huggingface dataset:
Stigma, Self-management, & Quality of Life in SCD

Many individuals with sickle cell disease experience both a poor quality of life and stigma. Individuals with SCD often experience high levels of stigma which can be a barrier to good self-management and hinder quality of life. The purpose of this research is to improve understanding of the relationships between stigma, self-management, and quality of life in SCD in the United States and Jamaica. The findings from this project will contribute to the development of a tool to measure self-management strategies and will also guide the development of interventions to improve SCD self-management.

The goal of the proposed study is to explore the complex relationships between perceived stigma, demographic and clinical characteristics, sickle cell disease (SCD) self-management strategies, and quality of life (QoL) in adults with SCD in the United States (US) and Jamaica, countries with important differences relevant to this study. Proposed is a cross sectional study that will use a convergent parallel mixed methods design (individual interviews and self-report surveys). Participants will be interviewed about SCD self-management strategies and how sources of stigma influence these strategies. Quantitative measures will be used to assess perceived stigma \[SCD Health-Related Stigma Scale (SCD-HRSS)\] and QoL \[Adult Sickle Cell Quality of Life Measures (ASCQ-Me): emotional impact, pain episodes, pain impact, sleep impact, social functioning impact, and stiffness impact; disease severity\]. The primary outcome of the study is stigma and the secondary outcome is QoL(emotional impact, pain episodes, pain impact, sleep impact, social functioning impact, and stiffness impact; disease severity).

The specific aims of this study are to:

Aim 1: Determine the influences of perceived stigma and demographic and clinical characteristics on SCD self-management and QoL in adults with SCD in the US and Jamaica.

Question 1: What are the influences of perceived stigma and demographic and clinical characteristics on SCD self-management? Question 2: What are the influences of perceived stigma and demographic and clinical characteristics on QoL? Aim 2: Describe the relationship between SCD self-management strategies and QoL.

Eligibility Criteria:
Inclusion Criteria:

1. at least 18 years of age,
2. ability to understand English,
3. diagnosis of SCD based on one of the following genotypes (ICD-10-CM code): HbSS (D57.0-D57.02), HbSC (D57.2-57.21), Hb SS/Bthalassemia+ or Hb SS/a-thalassemia- (D57.1, D57.4-D57.41, D57.8-D57.819).
Self-efficacy and Well-being of Patients With Fibrotic Interstitial Lung Disease

Patients with fibrotic insterstitial lung disease (ILD) participating in inpatient rehabilitation or in outpatient pulmonary care will be invited to participate in this observational study. Patients will fill out questionnaire regarding quality of life and symptoms at baseline and follow-up (at the end of rehabilitation or after the second outpatient ILD consultation). Additionally, clinical data obtained in clinical routine or for the IIP registry will be used for this project.

The aim is to assess changes in self-efficacy and quality of life over time and to establish a control cohort for a later feasibility study on a educational and self-management intervention (currently in planning).


Eligibility Criteria:
Inclusion criteria are:

* For Berner Reha Zentrum only: Diagnosis of a FILD as major indication for pulmonary rehabilitation
* For Inselspital only: Enrolled in Idiopathic interstitial Pneumonia (IIP) cohort study (Nr. 246/15 / PB_2016-01524) and agreed to further use of data for further research purpose
* Age ≥ 18 years
* Written informed consent

Exclusion criteria are:

* Cognitive inability or insufficient knowledge of project language (German) to follow informed consent or study procedures
* Sarcoidosis
Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine

This pilot study is designed to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine abortion.

The objective of this pilot study is to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine abortion.

Eligibility Criteria:
Inclusion Criteria:

* desires abortion

Exclusion Criteria:

* medically ineligible for procedure
Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery

This study is a clinical trial, prospective, randomized and double-blinded. Gabapentin oral 10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in children from 3 months to 16 years submitted unilateral limb surgery.

This study is a clinical trial, prospective, randomized and double-blinded. Gabapentin oral 10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in children from 3 months to 16 years submitted unilateral limb surgery. The children were divided into 2 groups: the gabapentin group (GG) was administered gabapentin 1 to 2 hours before procedure (N-40) and the placebo group (GP) was administered placebo 1 to 2 hours before surgery (N-44). Both groups were subjected to the same general anesthesia protocol, opioid free, and femoral and sciatic block with bupivacaine 0.125%. All patients received dipyrone and rescue analgesic used was morphine into 2/2h. The variables studied were age, gender, weight, type of surgery, hemodynamics, postoperative pain and morphine consumption .

Eligibility Criteria:
Inclusion Criteria:

Children between 3 months and 16 years who were previously healthy submitted to unilateral lower limb surgery

Exclusion Criteria:

Children cardiac, pulmonary, renal and neurological diseases and allergy and refusal of parents, caregivers and patients to participate in the study.
Kidney-Sparing Surgery Compared With Kidney Removal in Treating Patients With Kidney Cancer

RATIONALE: Kidney-sparing surgery is a less invasive type of surgery for kidney cancer, and may have fewer side effects and improve recovery. It is unknown whether kidney-sparing surgery is more effective than kidney removal in treating kidney cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to completely remove the kidney with kidney-sparing surgery in treating patients with resectable kidney cancer.

OBJECTIVES:

* Compare time to recurrence and survival of patients with single, low stage, nonmetastatic, well localized, and well delineated renal cell cancer treated with partial vs radical resection.
* Establish the side effects of kidney-sparing tumor resection in terms of morbidity and mortality in these patients.
* Study the relationship between tumor size, histologic grade, histologic type, and the extent of local control following partial resection.
* Determine which prognostic factors are important in selecting candidates for conservative surgery.

OUTLINE: This is a randomized, multicenter study.

Patients are randomized to undergo radical nephrectomy and limited lymphadenectomy (arm I) or conservative surgery (arm II).

Patients are followed every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 1300 patients will be accrued for this study over 8 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Single renal T1-2 tumor suspicious for adenocarcinoma that meets the following requirements:

  * Solitary tumor on CT scan
  * Maximum diameter 5 cm
  * Located such that negative resection margins are assured
  * N0, M0, i.e., no nodal involvement or distant metastases

    * No invasion of renal pelvis, calices, or perirenal fat as determined by CT scan or intravenous urography
  * Normal contralateral kidney present
* No von Hippel-Lindau disease

PATIENT CHARACTERISTICS:

Age:

* Any age

Performance status:

* WHO 0-2

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No second malignancy except adequately treated nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
The Correlation Among Nutrition, Muscle Strength, Masticatory and Swallow Ability of Inpatient Elders

The masticatory performance would affect the nutritional status of elderly people. the prevalence of undernutrition among elderly inpatients is %20-50%. Previous related studies investigate the masticatory performance with special chewing gum and self-reported questionnaires. This study observes the correlation of masticatory muscles sEMG, nutritional status, and handgrip force among elderly inpatients.

In this cross-sectional study, we enrolled 120 seniors aged 65 and above who are newly admitted to the Asian University Hospital. Within 24 hours they admitted to the hospital, we collected the Mini Nutritional Assessment scores, surface electromyography data, handgrip strength, self-assessment swallowing ability score, and clinical objective data. We performed the statistics for independent t-test, Pearson correlation analysis, and binary logistic regression with SPSS 23 software.

Eligibility Criteria:
Inclusion Criteria:

* new elderly inpatients aged 65 years or older who were able to communicate and were clearly conscious

Exclusion Criteria:

* Elderly individuals who were diagnosed with gastrointestinal (GI) dysfunction, dysphagia, edentulism without rehabilitation with dentures, brain disease, stroke or cancer were excluded due to the possibility of dysphagia, cachexia or masticatory muscle palsy.
Implant Stability Changes In Dental Implants Installed By Osseodensification and Conventional Methods

The aim of this study is to evaluate the effect of Osseodensification on implant stability during the healing period The objective of this study is to compare between dental implant stability after osteotomy site preparation using osseodensification technique and conventional drilling technique immediately after implant installation (primary stability) , 6 week after the insertion of implant and 12 weeks later (secondary stability)


Eligibility Criteria:
Inclusion Criteria:

1. medically fit patients ≥ 18 years of age including both genders
2. alveolar ridges of sufficient vertical and horizontal dimensions
3. bone density less than 850 Hounsfield units (HU) which corresponds to D3-D5 bone density according to Misch bone classification based on preoperative CBCT findings

Exclusion Criteria:

1. Patients with high bone density (more than 850 HU which corresponds to D1 and D2 according to Misch classification are not suitable for osseodensification.
2. Patient with severe buccal plate undercut or concavity
3. Active infection or inflammation in the implant zone
4. Presence of any uncontrolled systemic diseases.
5. Any patient need advance treatment such as sinus lifting and bone augmentation.
A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel Plus or Minus Sorafenib (BAY 43-9006) in Chemonaive Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)

A randomized controlled trial comparing safety and efficacy of carboplatin and paclitaxel plus or minus sorafenib in chemonaive patients with stage III-IV non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Stage IIIB (with effusion) or Stage IV NSCLC any histology
* No prior chemotherapy
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Greater than or equal to 18 years of age
* Life expectancy at least 12 weeks
* Adequate bone marrow, liver and renal function

Exclusion Criteria:

* Prior systemic anti cancer therapy
* Known brain metastasis. Patients with neurological symptoms should undergo at computed tomography (CT) scan/magnetic resonance imaging (MRI) of the brain to exclude brain metastasis
* Pulmonary hemorrhage/bleeding event \> Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 within 4 weeks of first dose of study drug
* Thrombotic or embolic events including Transient ischemic attack (TIA) within the past 6 months
* Uncontrolled hypertension
* Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug
* Major surgery within 4 weeks
* Evidence or history of bleeding diathesis or coagulopathy
Discrimination of P and T Waves With Linq and Holter

Currently loop recorders diagnose arrhythmias and send automatic alerts to physicians based on R to R relationships only. We believe arrhythmia diagnostics could be improved if accurate detection of P and T waves as well as QRS complexes were possible.

There is no technique available for long term outpatient monitoring of QT intervals for patient at risk of torsade de pointes when receiving QT prolonging drugs. We believe that if an accurate T wave detection algorithm were developed loop recorders could be used to monitor the QT interval, and perhaps even provide alerts for patients at risk.

The objective of this study is to see if an algorithm can be developed to accurately define P and T waves using data from an implantable loop recorder.

Pilot Study of 20 prospective cardiology patients with loop recorders currently implanted for standard clinical indications.

Eligible Subjects will be brought into the office of John Wilson, MD or Marshall Winner, MD. After informed consent is obtained from Hatton Research Staff the following will be performed:

* subjects will have an initial loop recorder download to USB flash drive
* 12 lead EKG
* Annotated QT intervals on a 30 second rhythm strip
* 24 hour Holter monitor placed by Hatton Research Staff in order to confirm the loop recorder data.
* Subjects will be instructed on the Holter monitors care and use.
* Subjects will be scheduled to come back to the office after 24 hours to return the Holter monitor and have a final loop recorder download completed.
* Data from the loop recorder, Holter monitor, 12 lead EKG, and 30 second rhythm strip will be downloaded and de-identified per Hatton Research Staff.
* All de-identified data from the initial loop recorder download, 12 lead EKG, 30 second rhythm strip, final loop recorder download, and Holter monitor will be sent to Medtronic for algorithm development.

Independent Variables: These variables include age and race Dependent Variables: These variables include the data from the loop recorder, 12 lead EKG, Holter monitor and 30 second rhythm strip.

Intervention or experimental aspect of the study Subjects will have a 12 lead EKG performed with 30 second rhythm strip Subjects will complete a period of 24 hours in which they will wear a Holter monitor applied by Hatton Research Staff.

Statistical Analysis

* Descriptive statistics (mean, standard deviation) will be calculated for all continuous variables. Continuous variables will be compared using Student's - T test or ANOVA as appropriate.
* Frequency and percentages will be calculated for all categorical variables.
* Categorical data will be compared using chi square or Fisher's Exact Test as appropriate
* Data variables will be assessed by Hatton Research Specialist

Eligibility Criteria:
Inclusion Criteria:

* Subject currently has a Medtronic loop recorder implanted
* Subject has large enough P and T wave amplitudes present per discretion of MD.

Exclusion Criteria:

* Subjects with inadequate sized P and T waves
Observational Study for Melanoma Adjuvant Treatment With Tafinlar® + Mekinist® (Dabrafenib + Trametinib)

The primary objective for this non-interventional study was to assess the quality of life of melanoma patients under adjuvant treatment with dabrafenib and trametinib in real world setting in Portugal through disease specific FACT-M questionnaire and generic EQ-5D-3L questionnaire. The secondary study objectives were to assess the usage of adjuvant dabrafenib and trametinib in clinical practice and to evaluate clinical outcomes in patients that started adjuvant treatment with dabrafenib and trametinib. In addition, this study aimed to explore if treatment discontinuation affects clinical outcomes in real-world practice.

The prospective registration of completely resected high-risk stage III melanoma patients treated with dabrafenib and trametinib in the adjuvant setting was planned to be based on collaboration with 8 centers of excellence on melanoma patients treatment, according to their expertise and experience.

Patients were recruited from participating centers in the routine setting. This was done only if the decision about starting treatment with dabrafenib and trametinib had already been made. All patients that complied with the inclusion criteria and that started treatment with dabrafenib+ trametinib during the recruitment period were considered to participate in the study, at investigator discretion.

Health related quality of life had to be assessed by FACT-M and EQ-5D-3L questionnaires after treatment initiation in a quarterly base, according to clinical practice, including the first visit after treatment completion.

Eligibility Criteria:
Inclusion Criteria:

* Patients with complete surgical resection of histologically confirmed AJCC (8th edition) clinical stage III (IIIA, IIIB, IIIC, IIID) melanoma, in whom a decision for adjuvant treatment with dabrafenib and trametinib has been made before entering the study

  * V600E/K mutation-positive cutaneous melanoma
  * Adjuvant treatment with combination therapy of Dabrafenib (Tafinlar®) and Trametinib (Mekinist®) as indicated in the SmPC and by prescription, that has been started before inclusion of the patient into the study;
  * ≥ 18 years of age
  * Written informed consent signed.

Exclusion Criteria:

* Lack of basic demographic (gender, age, age at diagnosis) and staging data (Stage at diagnosis; Breslow index; Clark level; BRAF mutation; BRAF test date; Surgery date).
A Multi-Centered Study of the Long-Term Effect of Salmeterol and Albuterol in Cystic Fibrosis

Long term use of bronchodilators in CF is beneficial to the improvement of pulmonary function and symptoms. This study is investigating the long-term benefit of administration of the drug Salmeterol, a bronchodilator. Salmeterol will be compared to albuterol or placebo. The medication will be inhaled twice a day for 6 months.

Patients that have been diagnosed with cystic fibrosis and are above 5 years and below 45 years of age are eligible. Subjects will be randomized into 1 of 3 groups. One group will get Salmeterol by multi-dose inhaler (MDI) 2 puffs 2 times a day, one group will get albuterol by MDI 2 puffs 2 times a day and the other will get placebo by MDI 2 puffs 2 times a day. Height and weight along with pulmonary function testing and vital signs will be monitored at the beginning of the study and at Visits 2, 3, and 4. Peak flow monitoring will be done each morning before study medication at home. A daily diary will be kept of this measurement. Subjects will be seen in the research center at visits 1,2,3, and 4. Telephone contact will be done at Day 15, 60, 120, and 150. Individual outcomes include a potential increase in pulmonary function testing and a decrease in frequency of pulmonary exacerbations, hospitalizations, and usage of antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* Ability to perform reproducible spirometry
* FEVI \> 50% and \< 90% (Knudsen)
* A CF pulmonary exacerbation within the last year or an FEVI\<80%
* At least one delta f508 allele on CF mutation analysis
* Ability to demonstrate use of inhaled medicine and FEVI and PEFR monitor
* Written informed consent
* Negative serum pregnancy test on enrollment
The Dental Care Revolution: Health Education Using AI or Humanized Counseling on Plague Control and Periodontal Treatment Outcome in Patients With Periodontal Disease

The aim of this study was to evaluate the long-term effectiveness of an AI dental monitoring intervention on patients' periodontal disease, preventive behaviors and motivation. This randomized controlled trial included experimental group: AI group (EG-A), AI-humanized group (EG-B) and control group(CG), respectively.

The EG-A and EG-B received AI dental monitoring intervention by taking mouth image at home once a week for six month. Baseline and follow-up surveys were used to collect the data in oral health related quality of life,periodontal parameters, periodontal preventive behaviors and motivation.

A randomized experimental design was used. Patients with periodontal disease whose aged 35-65 years were recruited through department of Periodontics in Kaohsiung Medical University Hospital.

Each group was expected for 100 per group, patients will be randomized into each group. G\*Power (version 3.1.9.4) was used for power analysis.

All patients will underwent periodontal examination at baseline and at 1-month, 3-month, 6-month follow-ups.

Each patients will be diagnosed periodontal disease by dentist and have more than 16 functional teeth.

Each patients will completed the questionnaire at baseline and at 1-month, 3-month and 6-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age between 35-65 years old
* Diagnosed periodontal disease by dentist (Comprehensive Periodontal Treatment Project)
* More than 16 functional teeth

Exclusion Criteria:

* Have received periodontal treatment within 3 months
* Patient has disease related to periodontal disease (ex. Drug-related excessive gum growth or blood clotting problems, pregnancy, mental illness)
* Disability patients
Va Meh Du: A Sports-based Mental Health Promotion Intervention for Karenni Refugees

The goal of this clinical trial is to learn if a soccer program focused on mental health positively impacts mental health in Karenni refugee young boys and men. The main questions it aims to answer are:

Does mental health education provided during a sports program improve mental health coping for Karenni refugee young boys and men? Does participation in a sports-program improve social connection for Karenni refugee young boys and men?

Researchers will compare those receiving mental health education to a comparison group to see if mental health education improves mental health coping skills.

Participants will:

Participate weekly soccer practices for 6 months Receive mental health education or comparison activities Answer questions about their health, such as their coping skills, social connection, and physical activity


Eligibility Criteria:
Inclusion Criteria:

* For child/minor participants: 8-16 years old, self-identifies as Karenni, self-identifies as a boy, speaks English, currently lives in Piedmont Triad area of NC, has parental consent, assents to participate
* For adult participants--18 years of age, self-identifies as Karenni, self-identifies as a man, speaks English and Karenni, currently lives in Piedmont Triad area of NC, consents to participate, anticipates missing no more than 2 practices

Exclusion Criteria:

* \[for adult participants only\]: Criminal record indicating potential harm to children (i.e., convicted of a violent or sexual crime, registration in the Sex Offender Registry, Responsible Individual List, or Child Maltreatment Registry) or are expected to miss more than 2 practices