cyrilzakka/clinical-trials huggingface dataset:
Storytelling To Prevent Obesity and Encourage Responsive Feeding Practices in Young Children

The goal of this qualitative trial study is to assess the usefulness and acceptability of the intervention in diverse clinical and community settings. The main questions it aims to answer are:

* How many parents were approached and consented to participate?
* How many parents viewed the videos via link versus viewed the video with a discussion in group sessions?
* How did parents feel about the process of being recruited and interventions that they participated in?
* How did the providers feel about the intervention recruitment and delivery?
* How did the facilitators feel about their delivery of the material? Participants will complete a survey and an interview after completing second part of the intervention.

Researchers will compare handout, online-only video, and group class interventions to see if an intervention delivery is useful and accepted by parents or providers.

This is a pilot randomized trial to assess feasibility and acceptability of STORY. The study will recruit 30 parents. Parents will complete a questionnaire and dyad's heights and weights will be measured. Families will be randomized to the control group or 1 of 2 intervention delivery approaches (IA). Parents will be given a handout (controls), links to the videos to watch independently (IA 1), or information on how they will be contacted to schedule their intervention sessions (IAs 2). After 2 video/sessions, all parents will complete a written survey assessing their experience with the intervention and any change same at home; the written survey will reassess baseline measures. Intervention parents will also complete a semi-structured interview to assess the family's experience with the STORY trial.

Sub aim 2a: Feasibility: number of parents approached, number of parents consented Sub aim 2b: Adherence: number of parents who complete videos or sessions Sub aim 2c: Acceptability to parents and providers

Eligibility Criteria:
Inclusion Criteria:

* Parent of 2-4 year old child
* Is at least 18 years old
* Participant can read and write English
* The participant's child has no medical conditions that affect development, feeding, or growth

Exclusion Criteria:

* Participant is not a parent of a 2-4 year old child
* Parent is less than 18 years old
* Parent can not read and write English
* Participant's child has a medical condition that affects development, feeding, or growth
* Family/household member participating in study
Does DHEA IVF Outcomes in Poor Responders?

This study is a RCT to examine whether DHEA is capable of improving results for poor responders to ovarian stimulation during IVF treatment

Poor responders to ovarian stimulation for IVF may be either predicted or evidenced from previous treatment. The ESHRE criteria for poor responders will be used to select candidates for this trial. A power calculation determined that 200 subjects should be recruited to each arm to receive either DHEA or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 40 years
* Markers for poor ovarian reserve (AMH \<7 pmol/L(\<1.1 ng/ml) and/or AFC\< 7)
* Previous poor response to ovarian stimulation ( ≤3 oocytes with a conventional stimulation protocol)

Exclusion Criteria:

* Women \> 42 years
* Women with premature ovarian failure / premature menopause (FSH\>40 U/L). Women already taking DHEA.
* Patients with a known allergy to the trial drug or any of the active ingredients in the placebo.
STUDY02001740;22SCH740: Estradiol For ER+ Advanced Breast Cancer (ESTHER)

Determine whether subjects harboring ESR1-mutant/amplified breast cancer have a higher rate of clinical benefit from 17b-estradiol therapy than subjects with ESR1-wild-type breast cancer

Patients with endocrine-resistant breast cancer are eligible. Treatment Phase: Patients will be treated with 17b-estradiol until disease progression. At this point, the patient will end protocol therapy. Clinical benefit, progression-free survival, objective response, tumor metabolic response, and toxicity will be determined. Observational Phase (optional): After disease progression on 17b-estradiol, patients will be treated at their oncologist's discretion. Clinical benefit, progression-free survival, and objective response will be measured during this line of treatment of physician's choice until another instance of disease progression. In consented subjects who undergo a clinically indicated tumor biopsy of recurrent or metastatic disease prior to the start of 17b-estradiol treatment, when feasible, acquisition of additional tumor tissue is requested for research purposes. Optional: patients will be asked to provide tumor tissue via a research biopsy on Day 3-4 of 17b-estradiol treatment. Archived tumor tissue and clinical-grade tumor and plasma DNA/RNA sequencing results will be used for research purposes. Blood samples will be obtained at baseline, on Day 3-4 of 17b-estradiol therapy (optional), and upon disease progression on 17b-estradiol. Plasma and buffy coat will be extracted and frozen. Tumor tissue and plasma specimens will be analyzed to identify molecular biomarkers predictive of sensitivity/resistance to 17b-estradiol therapy

Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women with ER+ breast cancer.
* Metastatic or locoregional recurrence not amenable to treatment with curative
* intent.
* Received ≥1 prior line of endocrine-based therapy (e.g., including tamoxifen, aromatase inhibitors, fulvestrant, or combinations) in the advanced/metastatic setting

Exclusion Criteria:

* During the study Treatment Phase with 17b-estradiol, no concurrent anti-cancer therapies are allowed with the following exceptions:

  * Exception: Trastuzumab is allowed for the treatment of subjects with a history of HER2+ disease, and will be used at the physician's discretion.
  * Exception: Anti-resorptive bone therapies (e.g., bisphosphonates, denosumab) are permitted.
* Any investigational cancer therapy in the last 3 weeks.
* Known CNS disease, unless clinically stable for ≥ 3 months.
* History of any of the following:

  * Deep venous thrombosis.
  * Pulmonary embolism.
  * Stroke.
  * Acute myocardial infarction.
  * Congestive heart failure.
  * Previous malignancy not treated with curative intent, or with an estimated recurrence risk ≥30%.
Treatment of Hypertrophic Scars Using Fractional Laser and Fractional Laser-assisted Topical Corticosteroid Delivery

The objective of this study is to evaluate the efficacy and safety of using ablative fractional laser- assisted topical corticosteroid delivery for the treatment of hypertrophic scar.

Hypertrophic scars are common conditions that cause persistent symptom and can lead to severe psychosocial impairment. Intralesional corticosteroid have been a mainstay in the treatment of hypertrophic scars. However, there are many disadvantages of corticosteroid injection such as severe pain, skin atrophy, skin thinning, steroid acne, telangiectasia and hypopigmentation.

Recent reports propose new treatment methods for hypertrophic scars with the use of fractional ablative lasers to create zones of ablation of the skin that may assisted the penetration of drugs to the skin.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects with age range 18-60 years;
* Subject with hypertrophic scar from abdominal surgery for at least 3 months;
* Discontinued using oral isotretinoin for 6 months, alpha hydroxy acid or topical retinoic acid for 3 months

Exclusion Criteria:

* Subject who has skin Infection, photosensitive dermatosis or inflammatory acne on the treated area;
* Subject who smoke cigarette;
* Subject who was treated with Intralesional corticosteroid
A Real-world Study of Inclisiran Adherence, Treatment Patterns, Patient Characteristics, and Effectiveness in ASCVD Patients With Hypercholesterolemia, ASCVD-risk Equivalent Patients With Hypercholesterolemia and Familial Hypercholesterolemia

This was a descriptive, non-interventional, retrospective cohort study among patients with atherosclerotic cardiovascular disease (ASCVD) and hypercholesterolemia, ASCVD-risk equivalent (ASCVD-RE) or familial hypercholesterolemia (FH) administered inclisiran in a real-world setting in Austria.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were 18 years or older.
* Signed informed consent was obtained.
* Patients who received at least one inclisiran injection in the identification period.
* Patients with at least one diagnosis of ASCVD, ASCVD-RE or FH diagnosis prior to index date.
* Patients with at least one low-density lipoprotein cholesterol (LDL-C) measurement of 70 milligrams per deciliter (mg/dL) or greater, within 6 months prior to index date.

ASCVD was defined as previous diagnosis of coronary artery disease (CAD), peripheral artery disease (PAD) or cerebrovascular disease (CVD).

ASCVD-RE was defined as: no previous diagnosis of ASCVD at any time on the patient chart and they met at least one of the following criteria:

* Diagnosis of type II diabetes mellitus (T2DM).
* Diagnosis of type I diabetes mellitus (T1DM) of long duration (greater than 20 years).
* 10-year risk of 20% or greater by Framingham risk score.

Exclusion Criteria:

• None.
Biological Meshes in Infected Fields: a Randomized Controlled Trial

The SIMBIOSE trial is a large multicenter phase III prospective randomized controlled single blinded trial comparing the use of biological mesh versus traditional wound care without biological mesh in patients with an infected incisional ventral hernia. The primary endpoint is 6-month infectious and/or wound morbidity. Secondary endpoints are wound infection rate at 45 days, 3 months and 1 year, recurrent hernia rates at 1, 2 and 3 years, postoperative pain, quality of life, time to healing, need for wound reoperation, impact of the cross-linked mesh structure, and medico-economic evaluation. One hundred patients need to be included.

Comparison between standard wound care and the use of biological meshes in infected fields

Eligibility Criteria:
Inclusion Criteria:

* wound infection related to a synthetic non-absorbable mesh for at least 15 days duration
* incisional abdominal hernia with an abcess or fistula, without the presence of a synthetic non-absorbable mesh
* incisional abdominal hernias smaller than 20 centimeter in the 2 largest diameters
* incisional abdominal hernias requiring a surgical procedure
* incisional abdominal hernias amenable to repair with a single biological mesh
* age over 18 years

Exclusion Criteria:

* non-infected incisional abdominal hernia
* history of biological mesh placement
* incisional abdominal hernia in contaminated, but non infected field (stoma presence, violation of gastrointestinal tract)
* incisional abdominal hernia larger than 20 x 20 cm
* BMI ≥ 40 kg/m2
* ASA score 4 and 5
* immunosuppression (including steroid and cytotoxic therapy)
* chronic disease such as cirrhosis, renal insufficiency with renal dialysis, malignant disease, known collagen disorder
* life expectancy under than 36 months
* allergy to one of the biological mesh components
* pregnancy or breastfeeding
Comparison Between Arthrocentesis and Rocabado Exercises on Temporomandibular Disc Displacement Without Reduction

The present study will be designed to compare the short- and medium-term results of arthrocentesis and non-surgical methods Rocabado approach in early disc displacement without reduction.

This study will be designed to provide a comparison between the effect of the Rocabado approach as a conservative treatment and temporomandibular joint arthrocentesis in temporomandibular joint disc displacement without reduction.

Delimitations:

This study will be delimited in the following aspects:

1. Patients:

   The study group will be composed of sixty-eight patients with temporomandibular joint disc displacement without reduction will be enrolled in the study. Group A: It will be composed of thirty-four patients with TMJ disc displacement without reduction who are started on the Rocabado approach- 4 - 6×6 exercise program. Include therapeutic exercise, and patient education focusing on the temporomandibular joint. Repeat measurements will be performed on 1st measurement at the baseline before any intervention, 2nd measurement after 8 weeks of treatment by a physiotherapist. Group B: It will be composed of thirty-four patients with disc displacement without reduction who are started on TMJ arthrocentesis procedure with medical and nursing care.
2. Equipment and tools:

2.1-Measurement equipment: Thera bite ROM scale 8-Item Jaw Functional Limitation Scale (JFLS-8) (Valid Arabic version) visual anlogue scale 2.2-Therapeutic procedures: Rocabado's 6X6 Exercise Program and manibulation

Eligibility Criteria:
Inclusion Criteria:

* History of a sudden reduction in the mandibular opening. Unassisted mandibular opening 35 mm.
* Mandibular opening with assistance increased by ≥3 mm from
* unassisted opening, with a prior history of click, click disappearance, and a sudden decrease in opening.
* Magnetic resonance imaging (MRI) diagnosis of Disc displacement without reduction.
* Persistence of the symptoms indicated in the first item for a Maximum of 3 weeks.
* clinical diagnosis of unilateral Disc displacement without reduction of the temporomandibular joint.

Exclusion Criteria:

* History of major jaw trauma.
* Dentofacial deformity.
* Psychiatric illness.
* Chronic headache. Presence of other disorders involving the TMJ.
Sequential Therapy for Hypogonadotropic Hypogonadism

The traditional therapy for induction of spermatogenesis in male hypogonadotropic hypogonadism requires both HCG and human menopausal gonadotropin (HMG) or FSH until pregnancy occurs. Because of the high cost of hMG or FSH preparations and poor compliance, the investigators raise a new sequential therapeutic approach which can make the treatment more economic and tolerable. The zinc supplement will be also evaluated in patients in this study. This randomized, parallel, open, and multi-center study will compare the efficacy of traditional therapy with new therapy and evaluate the safety of the new protocol.


Eligibility Criteria:
Inclusion Criteria:

* Clinical hypogonadotropic hypogonadism
* Hormonal levels: Testosterone \< 1.8ng/ml, LH \< 2-3 mIU/mL and FSH \< 2-3 mIU/mL
* Infantile testis
* Delayed bone age
* Normal testing of the anterior pituitary gland

Exclusion Criteria:

* Prior therapy with HMG or FSH
* Severe dysfunction of live and kidney
* Cryptorchidism or no response to HCG stimulation experiment (Testosterone \< 1.8ng/ml after HCG stimulation)
* Another pituitary hormonal deficiency
* Hypergonadotropic hypogonadism
* With abnormal karyotype
Measuring and Improving Medication Adherence in Kidney Transplant Patients

Nonadherence to medication is a major obstacle to successful treatment of renal transplant patients. This study has two primary aims. The first is to test whether a culturally sensitive cognitive-behavioral adherence promotion program could significantly improve medication adherence to tacrolimus prescription. Participants will be randomly assigned to either group CBT or to standard care. The second aim is to pilot a novel strategy of adherence measurement - unannounced telephone pill counts, which has been shown to be a valid and reliable means to measure medication adherence in other patient populations. Participants will be recruited from waiting area of the kidney transplant clinic at SUNY Downstate Medical Center in Brooklyn, NY. Three unannounced telephone pill counts will be conducted prior to start of the intervention in order to establish baseline adherence and three pill counts will be conducted post-intervention. Tacrolimus trough concentration levels will also be collected as an additional biological measure of adherence.


Eligibility Criteria:
Inclusion Criteria:

- current prescription of tacrolimus less than 98% adherence to medication prescription as determined by three baseline pill counts

Exclusion Criteria:

- lack of telephone to complete pill counts lack of English proficiency to participate in adherence promotion sessions
Application of the Apsara Thermal Wand System

The purpose of this feasibility study is to gain an initial assessment of the acute safety and performance of the Apsara Thermal Wand System in human facial tissue.


Eligibility Criteria:
Inclusion Criteria:

* Nonsmoker
* Glogau class 1-3
* Previously chosen to undergo facelift

Exclusion Criteria:

* Pregnant, nursing
* Implanted electro-mechanical device
* Allergy to anesthesia or device metals
* Collagen vascular disease
* History of keloid or hypertrophic scar formation
* Uncontrolled diabetes
* Long term steroid or other immunologic inhibitor use
* Previous treatment to target area
* Does not consent to study
* Does not consent to photography or histological evaluation
Safety Study of Abatacept to Treat Rheumatoid Arthritis

The purpose of this study is to compare the incidence rates of infection, malignancy and death among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications for rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis
* Receipt of abatacept, other biologic disease-modifying drug, or any non- biologic disease-modifying anti-rheumatic drug
* Age 18 years or older

Exclusion Criteria:

* Below 18 years of age
The Effect of Mobile App Home Monitoring on the Number of In-Person Visits Following Ambulatory Surgery

This study evaluate if in an ambulatory breast reconstruction patient population at Women's College Hospital (WCH), can we avert in-person follow-up care through the use of mobile app home monitoring compared to conventional, in-person follow-up care in the first 30-days following surgery.

Women's College Hospital offers specialized surgical procedures, including breast reconstruction. Patients often travel great distances to undergo surgery. The average ambulatory breast reconstruction patient travels 76 km from home to hospital, with the furthest patient coming from 540 km away.

Most patients receiving ambulatory breast reconstruction have a low rate of postoperative events necessitating clinic visits. However, regular follow-up is still considered important in the early post-operative phase. Increasingly, telemedicine is used to overcome the distance patients must travel to receive specialized care. Telemedicine data suggests that mobile monitoring and follow-up care is valued by patients and can reduce costs to society (1-3).

Currently, Women's College Hospital is using a mobile application (QoC Health Inc., Toronto) to complement in-person postoperative follow-up care for breast reconstruction patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing breast reconstruction at Women's College Hospital. They must be able to use a mobile device and communicate in English.

Exclusion Criteria:

* They must be non-smokers because smokers carry increased rates of complication and both surgeons have a policy to solely operate on non-smokers (minimum smoke-free period of one month leading to surgery). Pain ratings captured in the VAS and QoR9 are important for judging quality of postoperative recovery. Pre-existing pain or an inability to take narcotics would compromise the reliability of these measures. Therefore, patients must not suffer from chronic pain. They must not be taking narcotic (morphine-like) medication for pain on a regular basis. They must not have an allergy to local anesthetics or morphine-like medications.

Accommodation of special populations: Patients with hearing or speaking impairments will be accommodated with the help of translator. The person who regularly attends visits with her will facilitate this, or if no such person is available, we will use a hospital translator. All patients will receive an explanation of the study and the consent form in writing. All material will be understandable by patients with a grade 6 reading level. If our patients have lower than a grade 6 reading level, we will ask them if there is a family member at home who could assist them with the use of the mobile device.
Long Term Prognosis of Taiwanese Patients With OSA

The purpose of this study is to explore long-term prognosis and to identify the predictors in Taiwanese OSA patients. Validation of the prediction model derived from NHIRD with the database of National Taiwan University Hospital (NTUH) sleep center is planed to determine the effects of different treatments on long-term prognosis.

Obstructive sleep apnea (OSA) is a common disorder characterized by intermittent hypoxia and sleep fragmentation. OSA is associated with cardiovascular morbidity and mortality, metabolic dysregulation, and neurocognitive dysfunction, which may bring worse prognosis. Continuous positive airway pressure (CPAP) is the standard treatment of OSA while the oral appliance and surgery are the alternative treatments. The differences of craniofacial features among races contributed to the race-specific presentations of OSA. Up to date, only limited studies investigated the long-term prognosis of OSA and most of them recruited Caucasians and African Americans. Moreover, most studies didn't address the impact of treatment other than CPAP on the long-term prognosis. .

National Health Insurance Research Database (NHIRD) in Taiwan enrolled 99% of whole Taiwan's population and has longer period of 10 years for follow-up, which is suitable for investigation of long-term prognosis and predictors in OSA. However, due to limited parameters for diagnosis and treatment, the results could be biased in such secondary database research. Center of Sleep Disorder in National Taiwan University Hospital (NTUH) established from 2006 has 2,600 sleep studies annually. Therefore, database and cohort from sleep center could offer the validations of the prognosis and predictors determined from NHIRD. In addition, the impact of all three treatment modalities, namely CPAP, oral appliance, and surgery, on long-term prognosis could be studied in the prospective way.

Therefore, in this project, we aimed to achieve three goals (1) To explore long-term prognosis and identify the predictors in Taiwanese OSA patients with NHIRD, where the prediction mode of prognosis was established (2). To validate the prediction model derived from NHIRD with the database of NTUH sleep center (3) To determine the effects of different treatments on long-term prognosis with prospective following NTUH sleep center cohort.

Eligibility Criteria:
Inclusion Criteria:

* NHIRD - \>=20 y/o; OSA ICD-9-CM code: 780.51,780.53,780.57, or 327.23; coexisted with PSG procedure code: 17008B,17008A.
* NTUH cohort - \>=20 y/o; PSG AHI\>5

Exclusion Criteria:

* patients refusing to anticipate our study