cyrilzakka/clinical-trials huggingface dataset:
A Randomized, Non-inferiority Clinical Trial of CVA Telerehabilitation Treatments - TelePhysioTaiChi

Telerehabilitation is a promising alternative approach that can help improve access to rehabilitation services once patients are discharged home after stroke. The investigators therefore postulate a non-inferiority hypothesis of the telerehabilitation approach compared to home visits to improve balance problem related to stroke. The platform used will be based on a technological infrastructure that was developed and tested in previous telerehabilitation studies. The study is a randomized control trial (RCT).The study population of interest will target individuals who have had a stroke who stayed in a hospital or chronic stroke population. Participants will be recruited during the hospitalization period at each of the three sites or in the community. The investigators expect to recruit 240 participants, 120 per group. The first evaluation will be conducted at recruitment to establish the baseline measures. The two other evaluations will be conducted 2 months (T2) and four months (T3) following recruitment.


Eligibility Criteria:
Inclusion Criteria:

* have had a stroke with a Rankin score of 2 or 3;
* was not referred to an Intensive Functional Rehabilitation Unit (IFRU) and returned home following discharge from hospital;
* understands instructions to allow participation in evaluations and interventions;
* has a balance problem as evidenced by a score between 46 and 54 on the Berg Balance Scale96;
* has a caregiver that would be available during the telerehabilitation sessions to ensure safety during exercises;
* live in an area serviced by high speed Internet.

Exclusion Criteria:

* severe body hemineglect;
* significant hemianopsia visual problems accompanied by hemineglect;
* uncontrolled medical problems;
* moderate to severe aphasia
Tranexamic Acid (TXA) in Pediatric Cardiac Surgery

The purpose of this study is to determine tranexamic acid plasma levels in children undergoing cardiac surgery at risk of bleeding and to compare two dosing regimens.

Tranexamic acid (TXA) is administered intravenously to prevent bleeding associated with cardiac surgery and by pass in adult and children. The pharmacokinetic of this product is unknown in the pediatric population. Only a few studies report a clinical efficacy with different dosages. The purpose of this study is to determine the plasma level of TXA using two different administrations methods: continuous versus intermittent. The second objective is to determine whether fibrinolysis decreased. The population consists in children weighting 10 to 30 Kilos, undergoing cardiac surgery and at high risk of bleeding.

Eligibility Criteria:
Inclusion Criteria:

* children weighing between 10 and 30kg surgery with cardiopulmonary bypass for congenital heart disease deemed hemorrhagic

Exclusion Criteria:

* the patients undergoing a surgical procedure short and simple
* patients with past history of convulsions neurologiques especially allergies to the TA
* patients with renal insufficiency
Tailored Intervention for Melanoma Patient's Families

The purpose of the investigators' study is to find the best way to provide information about sun protection and skin cancer detection. The investigators want to see which of two methods most improves sun protection and screening attitudes and practices. The investigators hope to improve these attitudes and practices among people who are at higher risk for melanoma. People at higher risk for melanoma are first degree relatives (mother, father, sibling or child) of people diagnosed with melanoma.

Eligible patients will be contacted to find out whether they have any living first degree relatives that we may contact to discuss their participation in our study.

Eligible first degree relatives (FDRs) will participate in our study as outlined under Interventions.

Eligibility Criteria:
Inclusion Criteria - Patients (for referral of FDRs):

* Newly diagnosed with cutaneous malignant melanoma (CMM) within the past 2 years but more than 3 months prior to being approached
* Seen at FCCC, FCCC Network, Temple, MCC, or HUP patient clinics
* Greater than 18 years of age
* English speaking
* Able to give meaningful informed consent
* Does NOT have a first-degree relative with CMM

Inclusion Criteria - FDR (First Degree Relative):

* Current age of at least 21 years
* One or more of the following additional risk factors; blonde or red hair; marked freckling on the upper back; history of 3 or more blistering sunburns prior to age 20; 3 or more years of an outdoor summer job as a teenager; Actinic keratosis
* Able to give informed consent
* English speaking
* Has residential phone service
* No personal history of CMM or non-melanoma skin cancer
* No personal history of dysplastic nevi

Exclusion Criteria - FDR:

* 2 or more first degree relatives with CMM
* Has had a total cutaneous examination (TCE) in the past 3 years AND has done skin self-examination (SSE) more than once in the past year AND has a sun protection habits mean score greater than or equal to 4 (often). We are selecting a set participants who are NOT compliant with TCE and are inconsistent/minimal performers of SSE and sun protection practices.
Polyacrylamide Hydrogel Injection in HIV-related Lipoatrophy

Combined antiretroviral therapy (cART) is associated with facial lipoatrophy, which is potentially stigmatizing for HIV-positive patients. Eutrophill is a 2.5% polyacrylamide hydrogel obtained by polymerization of acrylamide monomers with an official half-life of 5 years.

Preliminary encouraging results with the use of polyacrylamide hydrogel for reconstruction of facial lipoatrophy in HIV-infected patients have been previously reported.

The primary objective of the study was to evaluate the long-term efficacy and safety of subcutaneous facial injections of Eutrophill in HIV-infected patients with severe facial lipoatrophy as assessed by facial ultrasonography at screening , after 6, 12 and 24 months

Combined antiretroviral therapy is associated with facial lipoatrophy, which is potentially stigmatizing for HIV-infected patients.

To date, polylactic acid implants (PLA) have been approved for the correction of facial lipoatrophy. The mechanism of action is the increase in new collagen synthesis as a reaction to the presence of the implant in the dermal area. But PLA may be associated with:subcutaneous micronodules and indurations and mid term relapse of lipoatrophy with the need to proceed to new PLA injections EUTROPHILL is a 2.5% polyacrylamide hydrogel with a claimed half-life of 5 years.The gel is relatively viscous and is injected subcutaneously. Following injection, the gel encapsulates. The mechanism of action is the increase in the volume of subcutaneous area by the inert implant

The aim of this multicentric, open-label, single-arm, pilot study was to evaluate the long-term efficacy and safety of intra-dermal facial injections of polyacrylamide hydrogel (EUTROPHILL) in HIV-infected patients with severe facial lipoatrophy. Patients received between 2 and 6 injections every 4 weeks, according to the aesthetic results.

The primary objective of the study was to evaluate the long-term efficacy of subcutaneous facial injections of EUTROPHILL in HIV-infected patients with severe facial lipoatrophy as assessed by facial ultrasonography at screening , after 6, 12 and 24 months

The secondary objectives of the study were:

to evaluate the clinical efficacy by facial photography at screening, after 6, 12 and 24 months; to evaluate Overall Treatment Satisfaction according to patients , close relatives and physicians ; to evaluate changes in quality of life (ABCD questionnaire) ABCD questionnaire is a specific questionnaire validated for HIV-infected patients suffering from lipodystrophy; to evaluate changes in patient's anxiety and depression (HADS questionnaire); to evaluate the safety of the infiltration techniques;

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected patients
* 18 years of age or older
* Severe facial lipoatrophy.
* Stable antiretroviral treatment at least 3 months prior to the inclusion
* CD4 cell count \> 100 cells/mm3
* Written informed consent

Exclusion Criteria:

* History of surgical or cosmetic intervention for facial lipoatrophy
* Ongoing opportunistic infection
* Any facial skin disease including Kaposi Sarcoma
* Pregnancy
Bascom Cleft Lift for Primary Wound Healing in Complex and Recurrent Sacrococcygeal Pilonidal Sinus Disease

The goal of this observational study is to improve care for patients with complex or recurrent pilonidal sinus disease by developing and implementing a best practice care pathway, including a standardized cleft lift operation.

The main question it aims to answer is: Does a best practice care pathway with standardized cleft lift operation lead to shorter wound healing time and time to return to normal activities, compared to current standard care, with traditional excision techniques.


Eligibility Criteria:
Inclusion Criteria:

* 16 years of age and older
* Symptomatic complex or recurrent pilonidal sinus disease
* Planned for surgical treatment
* Signed informed consent

Exclusion Criteria:

* Pregnant
* Insufficient understanding of the Dutch language or otherwise unable to give consent
Effects of a Movement Training for Subacromial Pain Syndrome

Objectives: Evaluate the effects of a rehabilitation program based on movement training on symptoms, functional limitations and acromiohumeral distance (AHD) in individuals with SPS.

Methods: Twenty-five participants with SPS participated in a 6-week program. Outcomes of both groups were evaluated at baseline and 6 weeks. Changes in symptoms and functional limitations were assessed. Changes in AHD for both groups were assessed using ultrasonographic measures.

Background: Multiple factors have been associated with the presence of a subacromial pain syndrome (SPS), including deficits in performance of scapular and glenohumeral muscles. Such deficits can lead to inadequate kinematics and decreased acromiohumeral distance (AHD). Exercises that aim at correcting these deficits, such as movement training, were suggested to improve symptoms and functional limitations. To date, few studies have assessed outcomes following an intervention focused on movement training.

Objectives: Evaluate the effects of a rehabilitation program based on movement training on symptoms, functional limitations and AHD in individuals with SPS.

Design: Prospective single group pre-post design. Methods: Twenty-five participants with SPS (SPS group) participated in a 6-week program. Twenty asymptomatic volunteers were recruited for normative AHD values (control group). Outcomes of both groups were evaluated at baseline and 6 weeks, i.e. immediately following intervention for the SPS group. Changes in symptoms and functional limitations for SPS group were assessed using the Western Ontario Rotator Cuff index (WORC) and Disability of the Arm Shoulder and Hand questionnaire (DASH). Changes in AHD for both groups were assessed using ultrasonographic measures.

Eligibility Criteria:
Inclusion Criteria:

* painful arc of movement during flexion or abduction
* positive Neer or Kennedy-Hawkins impingement signs
* pain on resisted lateral rotation, abduction or empty can test.

Exclusion Criteria:

* previous shoulder surgery
* shoulder pain reproduced by neck movement
* clinical signs of full-thickness RC tears
* shoulder capsulitis.
Pilot Evaluation of an Interactive Health Game

Broad, diverse, and innovative efforts are needed to address the growing dual public health challenges of obesity and diabetes, especially for those at increased risk like minority older adults. The emerging field of health games offers an innovative opportunity to reach populations to provide healthy eating and physical activity messages. Little research has focused on the use of health games specifically tailored for older adults. This study builds upon a health game designed to provide knowledge, facilitate movement, enhance motivation, and encourage healthy eating (HE) and physical activity (PA) behaviors in youth. This study will adapt, implement, and evaluate the feasibility, acceptability, adherence, and preliminary outcomes of the game among overweight/obese African American older adults.


Eligibility Criteria:
Inclusion Criteria:

* Age between 50 and 65 years
* Overweight or obese (25kg/m2 ≤ BMI \< 40kg/m2)
* African American/Black by self-report
* Risk factors for diabetes (based on adapted ADA risk test)

Exclusion Criteria:

* Adults with cognitive impairments, based on the adapted Mental Status Questionnaire (MSQ).
* Health conditions that preclude participation in physical activity program, based on the Exercise Assessment and Screener for You (EASY) physical activity screener.
* Already diagnosed with diabetes by self-report
* Currently engaging in vigorous physical activity
* Non-English speaking
* Does not meet inclusion criteria
Impact of Nudges on Downloads of COVID-19 Exposure Notification Smartphone Apps: A Randomized Trial

Eligible participants who were active beneficiaries of a large insurer living in Pennsylvania were sent an email encouraging them to download the contact tracing app in Pennsylvania, COVID Alert PA.

Participants will be randomly assigned to one of four conditions in a 2 (Self-benefit vs. Other-Benefit) x 2 (Social Norms Present vs. Social Norms absent) design.

All participants received an email that said :

"COVID Alert PA is the official Exposure Notification App from the Pennsylvania Department of Health. Join Penn Medicine in the fight against COVID-19 and download COVID Alert PA today!"

---Investigators manipulated the content here---

"The app uses Bluetooth to sense when one person is in close contact with another person with the app. If someone tests positive for COVID-19, and they decide to upload the information to the health department, people who have the app and who have been in contact with them will be alerted.

If you are interested in downloading the app, please click COVID Alert PA. We appreciate you joining our efforts. Together we can beat COVID-19!"

In the Other-Benefit condition, it said: "It can help you reduce your risk of unknowingly spreading the virus to your friends, family, and larger community."

In the Self-Benefit condition, it said: "It can help you determine where and when to get testing, and how to get care if you need it."

In the Social Norms Present condition, it said: "Over 650,000 Pennsylvanians have already downloaded the app!"

In the Social Norms Absent condition, it said the statement about social norms above.

Participants who do not open the initial email received a follow-up email.


Eligibility Criteria:
Inclusion Criteria:

* Eligible participants were active beneficiaries of a large insurer living in Pennsylvania.

Exclusion Criteria:

* Participants who did not subscribe to offers and promotions emails were excluded, as were Medigap beneficiaries.
Post-HSCT Medication Adherence mHealth App

Through a mixed methods, quasi-experimental design, the study will first focus on developing a mobile health (mHealth) adherence application and evaluating usability and acceptability of the app among caregivers of children in the acute phase post-HSCT. The purpose of this project is to explore the feasibility and acceptability of a mHealth application through user testing and thematic content analysis.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* \>18 years of age

Exclusion Criteria:

* Caregivers with developmental delays or conditions that make processing and responding to verbal questions challenging/frustrating either online or in a group forum
DNA Analysis in Samples From Younger Patients With Germ Cell Tumors and Their Parents or Siblings

This research trial studies deoxyribonucleic acid (DNA) samples from younger patients with germ cell tumor and their parents or siblings. Studying samples of tumor tissue and saliva from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

OBJECTIVES:

I. To evaluate associations between genetic variation and pediatric germ cell tumor (GCT) using a case-parent triad design to identify variants in four genes, KITLG, SPRY4, BAK1, and DMRT1, associated with pediatric GCT.

II. To evaluate associations between genetic variation and pediatric GCT using a case-parent triad design to include targeted genotyping of single nucleotide polymorphisms (SNPs) in selected key pathways essential for normal in utero germ cell development, specifically genes involved in survival of germ cells during migration, apoptosis, and cell cycle control.

III. To explore inter- and intratumoral heterogeneity in DNA methylation by tumor histology.

OUTLINE: This is a multicenter study.

Patients and parents or siblings undergo saliva sample collection. DNA extracted from saliva samples and from patients' archived tumor tissue samples is genotyped and analyzed by methylation arrays, including methylation-specific polymerasechain reaction (PCR) (pyrosequencing) assays. Genetic variation between pediatric germ cell tumors and parent or sibling is also analyzed. Patients' and family members' health history, demographics, and environmental exposures are collected by questionnaires or telephone interviews. Medical history, such as chronic conditions, prescribed medications and congenital abnormalities, including cryptorchidism, is also collected. Birth characteristics of the child, including birth weight and gestational age, are also captured.

Eligibility Criteria:
Inclusion Criteria:

* The patient is enrolled on COG-ACCRN07
* The patient has a primary diagnosis of germ cell tumor (GCT) including germinoma (ICCC 9060-9065) teratoma (9080-9084), embryonal carcinoma (9070-9072), yolk sac tumor (9071),choriocarcinoma (9100, 9103, 9104), and mixed GCT (9085, 9101, 9102, 9105) in all sites including the brain and central nervous system and registered with Children's Oncology Group (COG) by a North American member institution
* The patient must be diagnosed with a germ cell tumor between July 1, 2008 and December 31, 2015
* The patient must be \< 20 years of age at the time of diagnosis
* The patient must have at least one biological parent alive and willing to participate

  * In the event that one case parent cannot contribute DNA, a case sibling, defined as the biological brother or sister of the study subject, may donate instead
* All questionnaire respondents must understand English or Spanish
* Concomitant treatment on a therapeutic trial is not required
Blended Treatment for Alcohol Use Disorder

Blended Treatment for Alcohol Use Disorder (BLEND-A) is a pragmatic, cluster randomized controlled trial to assess the clinical effectiveness and cost-effectiveness of implementing a blended treatment format that aims to reduce problematic alcohol use. Blended treatment is a treatment format where treatment as usual is offered as a combination of online and face-to-face sessions, integrated into one treatment protocol. The BLEND-A study will evaluate and implement a blended treatment program in routine alcohol addiction treatment. The trial is led by Unit of Clinical Alcohol Research, University of Southern Denmark (UCAR) in collaboration with partners at the Centre for Telepsychiatry in the Region of Southern Denmark (CTP), and Sundhed.dk.

Background: A major challenge to psychological treatment for Alcohol Use Disorder (AUD) is patient non-compliance. A promising new treatment approach that is hypothesized to increase treatment compliance is blended treatment, consisting of face-to-face contact with a therapist combined with modules delivered over the Internet within the same protocol. While this treatment concept has been developed and proven effective for a variety of mental disorders, it has not yet been examined for AUD.

Aims: The study described in this protocol aims to examine and evaluate patient compliance with blended AUD treatment as well as the clinical and cost effectiveness of such treatment compared to face-to-face treatment only.

Methods: The study design is a pragmatic, stepped-wedge cluster randomized controlled trial. The included outpatient institutions (planned number of patients: n=1800) will be randomized in clusters to implement either blended AUD treatment or face-to-face treatment only, i.e. treatment as usual (TAU). Both treatment approaches consist of motivational interviewing and cognitive behavioral therapy. Data on socio-demographics, alcohol consumption, addiction severity, treatment retention, treatment duration and intensity, and type of conclusion of treatment (dropout vs. compliance), will be retrieved from the National Register of Alcohol Treatment (NAB). In addition, all patients will be assessed for alcohol consumption, consequences of drinking and quality of life at treatment entry and six months after treatment conclusion. Data will be analyzed with an Intention-to-treat approach by means of generalized mixed models with random effect for cluster and fixed effect for each step. Also, analyses evaluating cost-effectiveness will be conducted.

Discussion: Blended treatment may increase treatment compliance and thus improve treatment outcomes due to increased flexibility of the treatment course. Since this study is conducted within an implementation framework it can easily be scaled up, and blended treatment has the potential to become an alternative offer in the majority ofmany outpatient clinics nationwide.

Eligibility Criteria:
Inclusion Criteria:

* Legal person seeking public alcohol treatment in the participating municipalities.

Exclusion Criteria:

* None.