cyrilzakka/clinical-trials huggingface dataset:
A Novel Parent Education Program for Early Intervention

One in ten infants born in the USA is born preterm before 37 weeks of gestation and 50% of those will have motor and cognitive delays requiring intervention at school age. Because existing assessments do not reliably identify motor and cognitive delays early in development, many infants born preterm do not receive early intervention until they are older and their delays are more pronounced. This project aims to address the need for an effective, affordable, novel early intervention model for the first months of life for preterm infants.

One in 10 children in the United States is born preterm and at risk for disabilities that can impair movement and cognition. Research suggests that targeted early intervention can effectively improve ability and function for these children. However, two key obstacles limit the provision of early intervention services in the first half-year of life. First, the existing diagnostic tools are limited in their ability to identify motor and cognitive delays at early ages. Second, in the medical model there is a lack of understanding of developmental science and how experiences in the first months of life can impact the development of future abilities. In effect, there has been lack of knowledge regarding who should receive early intervention services and what activities should be the focus of those services in infancy.

This project aims to address these challenges by testing the fidelity and short-term efficacy of a novel intervention providing education for parents of preterm infants. The intervention will educate parents on ways to handle, position, and play with their infants to provide infants safe opportunities to explore new ways of moving and controlling their bodies and interacting with objects. Intervention provision will be documented and outcomes will be compared for 20 infants randomized to receive one of two types of developmental education. Pre- and post-assessments will compare motor control in prone, reaching ability, daily positioning practices, and parent-child interactions with toys to determine if there are differences in the short-term effects of the intervention. Intervention will occur for two months with parents logging activity daily. Measures related to dosage and how parents perform the intervention activities will be gathered to assess fidelity of the intervention.

Aim 1: To measure aspects related to fidelity for families participating in the study.

Aim 2: To determine if there is a difference in developmental outcomes for children who receive the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Infant meeting the age criteria
* Access to the internet
* Residence within driving distance of the University of Delaware
* Parental ability to read and communicate in English

Exclusion Criteria:

* Genetic diagnosis
* Progressive diagnosis such as spinal muscular atrophy
* Medical or movement restrictions that would interfere with participation in the study activities
Neohepatic Albumin-Bilirubin Scores on Renal Outcomes in Living-donor Liver Transplantation Recipients

This study investigates the association between post-reperfusion (neohepatic) ALBI scores and post-LT renal outcomes in living-donor LT (LDLT) recipients.

Acute kidney injury (AKI) after liver transplantation (LT) significantly affects patient and graft outcomes. The Albumin-Bilirubin (ALBI) score, an objective and sensitive index of liver function, has potential applicability in predicting outcomes following LT. This study investigates the association between post-reperfusion (neohepatic) ALBI scores and post-LT renal outcomes in living-donor LT (LDLT) recipients.

Eligibility Criteria:
Inclusion Criteria:

* living donor liver transplantation recipients (≥18 years)

Exclusion Criteria:

* preoperative serum creatinine (sCr) \> 1.4 mg/dL, diagnosed CKD or hepatorenal syndrome (HRS), or hemodialysis at baseline
Beta 3 Agonist Treatment in Heart Failure

Objective: The objective of the study is to assess the structural and functional cardiac effects of treatment with the beta 3 AR agonist Mirabegron in patients with chronic heart failure.

Design: The investigators are planning a study aiming at establishing proof of concept that treatment of patients with HF with Mirabegron has significant positive effects, as assessed by clinical and biochemistry measurements, but not by hard endpoints. The investigators are performing a combined dose-finding - chronic efficacy study.

The study is a randomized, placebo-controlled, double-blinded trial. The follow-up period is 6 months. 70 patients with chronic heart failure will be included.

Specific aims

1. Determine safety of administration of Mirabegron to patients with heart failure.
2. Determine if treatment with Mirabegron for 6 months induces beneficial cardiac structural remodelling in patients with heart failure.
3. Determine if Mirabegron improves symptoms and exercise capacity as indicated by questionnaires and 6 min walk test in patients with heart failure.
4. Determine effects of Mirabegron on cardiac conduction, repolarisation and rhythms and arrhythmias in patients with heart failure.
5. Determine effects of Mirabegron on circulating biomarkers in patients with heart failure.


Eligibility Criteria:
Inclusion Criteria:

1. Stable heart failure NYHA class II-III on ischemic or non-ischemic basis
2. Left ventricular ejection fraction (LVEF) \< 40%
3. Stable sinus rhythm (SR)
4. On optimised evidence-based pharmacological HF treatment stable \> 4 weeks with no current plan for changing HF therapy. The therapy must include a beta-blocker.
5. No change in diuretics \< 4 weeks
6. \>18 years

Exclusion Criteria:

1. Unstable cardiac condition
2. Acute myocardial infarction (AMI) or revascularisation \< 3 month ago
3. Atrial fibrillation (for technical reasons in relation to imaging and HR reporting)
4. Uncorrected significant primary obstructive valve disease
5. Planned major surgery including cardiac revascularisation
6. Hemodynamically significant obstructive cardiomyopathy
7. Stroke with significant neurological deficit
8. Acute myocarditis or constrictive pericarditis
9. Symptomatic bradycardia or \> 1. degree AV-block unless the patient has a pacemaker
10. Clinically significant hepatic (transaminases or bilirubin x 3 above upper reference level) or renal (GFR\< 50 ml/min/1,73 m2) diseases
11. Heart failure due to uncorrected thyroid disease
12. Cardiac mechanical support
13. \< 6 months after CRT
14. Uncontrolled hypotension (defined as symptomatic systolic blood pressure \< 90 mmHg) - or hypertension (defined as systolic at 180 mmHg or above and/or diastolic blood pressure at 110 mmHg or below)
15. Body mass index (BMI) \> 35
16. Unable to give informed consent
17. Reduced compliance
18. All women of child bearing potential will be required to use adequate contraception
19. Pregnant or lactating women
20. Treatment with a tricyclic antidepressant or CYP2D6 substrates other than beta-blockers or treatment with digoxin.
Study to See How Safe Curcumin is and How Well it Works When Used to Treat Mucositis in Patients Getting Chemotherapy

Oral mucositis is a common side effect from cancer treatment. Patients receiving chemotherapy and radiotherapy can get very painful sores in their mouth that compromise nutrition and oral hygiene as well as increase risk for infection, and can last for weeks. Currently, the only treatment for mucositis is oral hygiene to try to support recovery.

Curcumin (also known as Turmeric) is a frequently-used spice in India and Southeast Asia. Studies in cells and animals have shown that it can reduce the amount of bacteria and can prevent inflammation.

In this study, the investigators want to learn if a mouthwash made with curcumin is safe for people to use and if it can help their mucositis.

This is a phase I/II study involving 2 parts; a dose escalation to determine the maximum tolerated dose (MTD) of curcumin and an expansion at the MTD.

Oral mucositis is a common and often debilitating complication associated with cancer treatment. Treatment of mucositis is mainly supportive - oral hygiene is the means of treatment. Curcumin (Turmeric), a frequently-used spice in India and Southeast Asia, can reduce bacterial load and prevent inflammation in cultured epithelial cells and prevent chemotherapy- and radiotherapy-induced mucositis in animal models.

The primary objective of this Phase I/II study is to determine the maximum tolerated dose (MTD) of oral curcumin in patients who have chemotherapy-induced mucositis. The secondary objectives of this study are to determine whether or not oral curcumin has an acceptable safety profile or impacts oral mucositis health outcomes.

Eligibility Criteria:
Inclusion Criteria:

* ≥ grade 2 oral mucositis related to chemotherapy for cancer
* Ability to understand and the willingness to review and sign a written informed consent document.
* ≥ 18 years of age
* Willingness to use adequate contraception prior to study entry, for the duration of study participation and for 30 days after the last dose for women of child-bearing potential and men

Exclusion Criteria:

* Current use of therapeutic doses of anticoagulants such as warfarin or antiplatelet agents (prophylactic doses and agents are acceptable)
* Biliary tract obstruction or cholelithiasis
* History of gastric or duodenal ulcers or hyperacidity syndromes
* AST or ALT \> 2 x ULN
* Total bilirubin ≥ 2 x ULN
* INR \> 1.5
* Previous stem cell transplant (allogeneic or autologous)
* Preexisting oral disease, such as active oral infection, trauma to the oral mucosa or oral - ulceration prior to chemotherapy
* Known allergy/hypersensitivity to curcumin, yellow food coloring, or other members of the - Zingiberaceae (ginger) family
* Pregnant or breastfeeding
Qualitative Interviews With Healthcare Professionals

PLANNING PHASE- Qualitative interviews with Healthcare Professionals to assist in the development of a new Patient Reported Outcome Measure (PROM) to assess patient's emotional wellbeing, and perceptions of Total Knee Replacement (TKR) surgery for the treatment of knee arthritis.

The interviews for the SYNC01-PP-USA project will be conducted in person at the American Association of Hip and Knee Surgeons (AAHKS) annual conference in Dallas, Texas, USA during the 3rd, 4th, and 5th November 2022. The interviews will take approximately 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Healthcare Professionals who currently care for patients who have undergone Total Knee Replacement surgery.
* Healthcare Professionals who, in the opinion of the Investigator, can understand the project, co-operate with the interview process and are willing to be interviewed in person.
* Healthcare Professionals who are able to give voluntary, written informed consent to participate in this project and from whom consent has been obtained.
Breast Cancer Survivors: Main Physical and Psychosocial Problems After Completion of Treatment

Breast cancer directly affects women physically, psychologically and socially in the process of diagnosis, treatment and post-treatment. Despite the improvement in conventional breast cancer treatments that led to longer disease-free survival, many patients still suffer from physical, psychological, social and spiritual problems after treatment. The neglect of physical and psychosocial problems faced by patients who are between 1 and 2 years after the end of treatment negatively impacts the quality of life of this population.

The purpose of the study is to assess the overall quality of life and measure the impact on women who have survived breast cancer for at least 1 year (12 months) and 2 years (24 months) after the end of primary treatment and to identify possible repercussions of breast cancer and its treatments associated with Quality of Life.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer
* Adult women (age ≥ 20 years old and less than 60 years old)
* Patient who has been treated by surgery, with or without adjuvant chemotherapy
* Clinical Stages I, II and III
* Patients considered cured, without history of recurrences
* Patients who completed treatment within a minimum of 1 year and are currently being undergoing outpatient follow-up

Exclusion Criteria:

* Initial diagnosis of another type of cancer, other than breast cancer
* Bilateral breast cancer
* Patient unable to fill out the QoL questionnaire
* Patient with disease recurrence
* Patient with metastatic breast cancer
Prolotherapy Intervention in Patient With Frozen Shoulder

Introduction :

Prolotherapy is regenerative tissue therapy that is considered to be efficacious in reducing symptoms and morbidity of frozen shoulder, but only a few studies demonstrate the effect of prolotherapy at the biomolecular level, particularly the level of Matrix Metalloproteinase- I (MMP-1), Tissue Inhibitor Matrix Metalloproteinase (TIMP-1), as the biomarkers of cartilage repair.

Objective:

To determine the effect of prolotherapy on MMP-1, TIMP-1, and functional outcomes in frozen shoulder patients

Method:

a double-blind randomized controlled trial study involving participants who had been diagnosed with Frozen Shoulder. History taking, functional outcome assessment, MMP-1, and TIMP-1 were measured. The prolotherapy via intraarticular and extraarticular was performed four times, followed by the evaluation of functional outcome, MMP-1, and TIMP-1 at week 12

Alternative Hypothesis :

Prolotherapy will increase the MMP-1, TIMP-1 levels, and improve functional outcome among Frozen Shoulder patients

Design :

Double-blind randomized trial

Randomization :

Simple Randomization generated by an online randomizer

Sample Size :

Difference between two means of primary outcome where

1. mean difference (μ 1 - μ 2 ) = 0.47
2. pool variance = 0.09
3. Z 1-α/2 = 1.95 with type 1 error 5%
4. 1-β = 1.282 with power 90%. Yielding 16 patients for each arm

Detailed Intervention

1. Intervention group: Prolotherapy is given four times (Week 0, Week 2, Week 4, and Week 6)
2. Comparison group: Normal Saline is given four times with a timeframe similar to the intervention group

Injection location

1. Rotator Cuff muscles
2. Intraarticular glenohumeral joint
3. Subacromial bursa
4. long-heap of the biceps tendon
5. Acromioclavicular joint

Statistical analysis :

1. Descriptive statistic to elaborate baseline characteristic
2. Assuming the baseline characteristic between groups are similar, the independent t-test will be conducted to see the differences between group, whereas Mann Whitney will be performed for nonparametric data
3. Difference within-group (baseline and last day) will be measured by paired-t-test or Wilcoxon for non parametric scenario

Eligibility Criteria:
1. Inclusion Criteria

   1. Age 35-70
   2. Diagnosed with frozen shoulder
   3. At least showing symptoms more than 3 months
2. Exclusion Criteria

   1. Receiving other intraarticular injection
   2. Taking Nonsteroid Antiinflammation drugs 1 week prior to intervention
   3. Skin disorder around the injection site
   4. Septic arthritis
Cancer Prevention and Care Among Aged

This research represents a pioneering effort to design a brief, cost effective and readily transportable program that will enable disadvantaged elders to become more effective participants in their health care.

The intervention is expected to result in trained elders becoming more knowledgeable health care partners. Trained patients will be prepared for appointments and will engage their primary care physicians in active dialogue regarding cancer prevention and screening.

Based on self-advocacy, these patients are expected to receive better preventive care and report greater satisfaction with care. Program participation can subsequently contribute to general health improvements and minimize health disparities.

In a randomized controlled trial (RCT) with 400 older adults, the investigators will assess the efficacy of the "Speak Up" intervention (N=200) relative to an attention control group "Connect" program (N=200), aimed at enhancing social and civic engagement. Participants will now obtain resource materials that include decision aids and diary logs to bring to visits with doctors. The investigators will implement "Speak Up" and "Connect" programs in two unique study populations: 1) participants in the ongoing NCI study and 2) older adults attending senior center programs sponsored by Area Agencies on Aging (AAAs). Participants will be assessed prior to the intervention and 2 month, and 12 months post intervention. The investigators will have an observation window of 12 months to determine whether and when the older adult obtained screening. The selection of a shorter follow-up time frame will help reduce attrition.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Over the age of 65 from Area Agencies of Aging who are interested in participating

Exclusion Criteria:

* No exclusion
Evaluate the Pharmacokinetics (PK) of Methylnaltrexone (MNTX) in Healthy Adult Subjects

MNTX 1109 is a single center, open label study, composed of normal healthy adult subjects to evaluate the PK of MNTX and its metabolites administered once daily as a subcutaneous (SC) injection for a period of seven days. Blood samples will be obtained at screening and for drug concentration data.


Eligibility Criteria:
Inclusion Criteria:

1. Body weight ≥40 kg (88 lb)
2. In good health with no clinically significant abnormal findings on the physical examination, medical history or the screening 12-lead ECG
3. Non-smoker
4. Has no known allergies to study drug or other related chemically-related compounds (i.e. naltrexone, naloxone).

Exclusion Criteria:

1. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease
2. History of clinically significant allergies
3. Positive urine screen for drugs
4. History of positive blood screen for human immunodeficiency virus (HIV), hepatitis B virus (Hep B), or hepatitis C virus (HCV)
5. Prior exposure, allergy or known hypersensitivity to methylnaltrexone
6. Diagnosis of alcohol or substance dependence within the past 12 months.
Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study

The purpose of this study is to evaluate the thickness accuracy of Laser-assisted in situ keratomileusis (LASIK) flaps created with the LenSx® Laser.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with myopia or hyperopia and eligible for femtosecond laser initiated LASIK surgery;
* Best corrected visual acuity (BCVA) correctable to at least 20/25 in each eye;
* If contact lens wearer, willing to discontinue contact lens wear prior to screening procedures;
* Willing and able to return for ALL scheduled follow-up examinations;
* Willing and able to provide written informed consent;
* Eligible for bilateral LASIK procedures to be done on the same day;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Previous corneal surgery, corneal lesions that will impede laser treatment, corneal edema, hypotony, glaucoma, existing corneal implant, or keratoconus;
* Known sensitivity to planned study concomitant medications;
* Participation in any other ophthalmic drug or device clinical study for 30 days prior to or during the time of participation in this study;
* Irregular astigmatism, based on the Investigator's judgement;
* Pregnant, lactating or planning to become pregnant during the course of the study;
* Other protocol-specified exclusion criteria may apply.
Evaluation of the LithoVue Elite Ureteroscope With Intra-Renal Pressure Monitoring Technology: Examination of Surgeon Behavior and Post-operative Outcomes

The goal of this study is to evaluate the influence of real-time intrarenal pressure measurement availability on surgeons' behavior during ureteroscopy while using the ureteroscope LithoVue Elite.

Despite advances in surgical techniques and technology, preventable adverse events still occur in the operating room, with half of them attributed to poor non-technical skills of surgical teams. Therefore, it is essential to observe and measure surgeons' intraoperative non-technical skills and provide structured feedback to improve patient safety. The new LithoVue Elite™ disposable ureteroscope has the potential to impact surgeons' behavior during ureteroscopy, as it enables the measurement of real-time intrarenal pressures. The study is designed to evaluate urologists' behavior during ureteroscopic stone treatment with and without intra-renal pressure monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Males or females over 18 years of age
* Undergoing flexible ureteroscopy to address urinary stones located in the proximal ureter or kidney
* Total stone burden over 2 cm

Exclusion Criteria:

1. Undergoing bilateral stone treatment during the same procedure
2. Patients with known genitourinary anatomical abnormalities
3. Uncorrected coagulopathy
4. Patients with urinary diversions
5. Chronic external urinary catheters
6. Women who are pregnant
7. Immunosuppressed patients
Does Restriction of the Dominant Hand Due to Injury Improve Non-Dominant Hand Function?

Hand injuries result in the restriction of use of the injured hand within a splint or a plaster during the first 6 weeks which is critical for tissue healing. When the dominant hand is injured, patients experience more difficulty in daily life due to this restriction. Patients injured on their dominant hand mostly express that they are forced to use their non-dominant hand in their activities and as a result, the function of the non-dominant hand improves. However, the non-dominant hand function has not been analyzed in patients with restricted use of the dominant hand during the tissue healing period.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who need to use a splint for 6 weeks due to any pathology in their dominant hand
* Ages between 18-65
* Individuals who are within the first 10 days after the operation

Exclusion Criteria:

* Individuals with an isolated thumb injury
* Those who require bilateral use of the splint/have bilateral pathology
* Those who have a condition that prevents the use of the non-dominant hand
* Those who can use both hands equally/do not have a dominant side (ambidextrous/two-handed)
* Those who have a cooperative status that will not comply with the treatment program
* Data from individuals who do not use the splint as described during the 6-week follow-up period will not be included in the analysis.
Force Enhancement of Musculus Quadriceps Femoris During and After Excentric Muscle Activity in Vivo

Force enhancement (FE) describes the phenomenon of strength potentialization of a muscle cell or the complete muscle during and after active extension compared to the strength of an isometric contraction with same muscle length. The underlying physiological mechanism of this phenomenon is not completely known today. In vitro trials indicate that the interaction of an active and a passive component on the cellular level are responsible for the higher strength measurements. So far FE could be shown in vitro and in vivo on muscle fibers and small human muscles. Further research is needed for verification of the existence of FE in voluntary motor activity in everyday life. In order to approach this objective the investigators will scrutinize the functionality of the deliberately activated musculus (m) quadriceps femoris during and after active extension on the basis of in vivo studies.

The research proposal is resubmitted with no amendments made regarding content.

Eligibility Criteria:
Inclusion Criteria:

* Males without previous muscular or neurophysiological diseases
* Age between 20 and 40 years

Exclusion Criteria:

* Previous muscular or neurophysiological diseases