cyrilzakka/clinical-trials huggingface dataset:
Efficient Anterior Shoulder Ultrasound Reduction Multicenter Prospective Randomized Trial

The purpose of the study is to determine if using ultrasound to diagnosis and confirm reductions of shoulder dislocations impacts the length of an emergency department visit for this condition.

The purpose of the study is to determine if the length of the emergency department visit can be decreased and if patient exposure to x-rays can be reduced by utilizing an ultrasound to diagnose and confirm reduction in shoulder dislocations.

This study also seeks to determine if patients prefer ultrasound to x-ray when used to treat their shoulder dislocation.

Participants will be randomly assigned to one of two groups: either x-rays or ultrasound for the diagnosis and reduction confirmation of your shoulder dislocation.

Participant's shoulder dislocation will be treated per standard of care.

Participants will be asked to complete a short survey at the end of their visit.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are 18 years of age or older; and
2. Present to the VCU Emergency Department; and
3. Have clinical signs of uncomplicated shoulder dislocation; and
4. Agree to participation in the study; and
5. Provides a written consent to be included in the study.

Exclusion Criteria:

1. Patients who have a level 1 or 2 trauma activation, and/or;
2. Patients who are pregnant, incarcerated, or unable to consent, and/or;
3. Patients who have a past medical history of shoulder replacement in dislocated shoulder; and/or
4. Provider Discretion
Usage of Biological Patch Versus Plastic in the Laparoscopic Repair of Hiatal Hernias

The purpose of this study is to observe the effective and safety in the laparoscopic repair of hiatal hernia using biological patch versus plastic.

observation indicator:

1. incidence rate of complications,
2. postoperative hospital stay
3. readmission rate in 1st month after operation
4. recurrence rate after operation
5. hospitalization costs
6. Self-evaluation of gastroesophageal reflux symptoms and quality of life(QOL) in 6th-month, 1st-year,2nd-year,3rd-year,4th-year and 5th-year after operation

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Hiatal hernia
* Consistent with operation indications throughout the guideline of hiatal hernia by the Chinese Medical Association in 2003
* randomly select patch agreed by patients and family members

Exclusion Criteria:

* Poor general condition
* severe organ dysfunction
* No-tolerate anesthesia
* No-suitable for operation
* Emergency operation needed
* Serious adverse events appeared during the operation
* Sever intraperitoneal adhesion existed
* glucocorticoid with long-term use
* immunocompromised patients
* spirit disease patients
* automatically exit
* women who pregnant
Open-Label Placebo for Functional Dyspepsia

The study is evaluating the efficacy of open-label placebo for the treatment of functional dyspepsia.


Eligibility Criteria:
Inclusion Criteria:

* Functional Dyspepsia

Exclusion Criteria:

-
Diabetes Management Program for Hispanic/Latino

To compare Diabetes Telemonitoring to comprehensive outpatient management (COM) on critical patient-centered outcomes, including HbA1c.

The investigators propose a multiphase mixed method, Comparative Effectiveness Research Randomized Control Trial (CER RCT) to:

Specific Aim 1: Assess usability of an evidence-based DTM intervention utilizing a Community Based Participatory Research (CBPR) approach and adapt it to facilitate acceptability and feasibility in a population of H/L patients with T2D, and their caregivers and providers.

Specific Aim 2: Assess whether H/L patients receiving DTM attain significantly improved patient-centered outcomes compared to COM, through a CER RCT. Expected outcomes include improved diabetes quality of life (QoL), glucose management (GM), blood pressure (BP), cholesterol, medication adherence, and diabetes self-efficacy (SE), and reduced diabetes distress, problem areas in diabetes (PAID), inpatient utilization, unscheduled T2D physician visits and sick days.

Eligibility Criteria:
Inclusion Criteria:

* Hispanic patients with a diagnosis of diabetes
* Speaks English or Spanish

Exclusion Criteria:

* Patient is not Hispanic
* Patient does not have a diagnosis of diabetes
Assessment of Heterotopic Ossification of Elbow Joint in Relation of Serum Uric Acid.

Heterotopic ossification (HO) is a common complication after surgical repair of elbow trauma. Uric acid is the end-product of purine metabolism that has any physiological and pathogenic potential functions. However, the relationship of HO and uric acid has not been explored up to now. This study aimed to assess the relationship of HO and uric acid. The investigators retrospectively reviewed the demographics of participants who undergone the surgery for elbow trauma in our hospital between January 2012 and December 2018. One hundred participants included in our study. The participants were divided into two groups by the existing HO or not. The serum uric acid between both groups were compared by using the independent samples student T tests.

The investigators retrospectively analyzed the demographics of these participants in our hospital who underwent the surgery after trauma of elbow joint between January 2012 and December 2018. All of the participants had a previous history of elbow joint fractures including distal humerus fracture or proximal ulna fracture or capitulum radii fracture or elbow fracture dislocation. According to X ray or CT scan, the participants were divided into two groups. One group the participants had not existed radiographic evidence of heterotopic ossification or formatted ectopic lamellar bone. And the other group is the participants with radiographic evidence of heterotopic ossification. And we recorded patient serum uric acid, sex and age, Body Mass Index (BMI), the situation of joint trauma and comorbid conditions including diabetes mellitus or impaired blood glucose, gout, metabolic syndrome, osteoporosis and various vitamin deficiency diseases. Moreover, the grades of heterotopic ossification were recorded for all patients according to Hastings and Graham Classification System for Heterotopic Ossification at the Elbow Joint.

Eligibility Criteria:
Inclusion Criteria:

* Have a previous history of elbow joint fracture or dislocation that conform to its manifestations and signs. And it is diagnosed by X-ray test. HO must accord with the relative diagnostic criteria5 and have imaging evidences of heterotopic ossification.
* Have complete clinical and imaging dates.
* The age\>18 and no gender limitation.
* The patient is being a relatively stable physical and mental state without acute injection or diseases.

Exclusion Criteria:

* Have a history of diabetes mellitus or impaired blood glucose, metabolic syndrome and gout or renal dysfunction (creatinine ≥ 1.5 mg/dL) that apparently influence glucose, lipid and protein metabolic of the body.
* Have a history of taking drugs that can influence uric acid metabolic including gout suppressant, diuretic, small-dose aspirin (75\~300mg/d) or large-dose aspirin (\>3g/d), anti-tuberculosis drugs, immunosuppressor, nicotinic acid and anti-tumor drugs such as cyclophosphamide and so on.
MEthylphenidate in ADHD - Addiction(s) Comorbidity: Value of Adding a Cognitive Remediation Program to Improve Short- and Medium-term Therapeutic Response

MEthylphenidate in ADHD - Addiction(s) comorbidity: benefit of adding a cognitive remediation program to improve short- and medium-term therapeutic response

It seems essential to optimize the therapeutic management of patients suffering from ADHD/addiction(s) comorbidity by specifically targeting their neuropsychological deficits, in addition to the pharmacological and psychosocial approaches currently recommended. By intensively training deficient functions on the one hand, and promoting the development of compensatory strategies on the other, cognitive remediation could thus be a therapeutic tool of choice, producing beneficial effects that persist over time and translate into objectifiable changes in daily life. Cognitive training programs have been successfully proposed to patients with ADHD, but these were mainly programs designed for children, and very few studies have been carried out in adults, a fortiori in adults with ADHD-addiction(s) comorbidity.

The main aim of the study was to evaluate the effectiveness of cognitive remediation compared with the control program in addition to MPH treatment in reducing the functional impact of ADHD in patients with other addictive comorbidities, at the end of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age over 15 (patients treated in the "adult" stream);
* Diagnosis of ADHD confirmed by DIVA-5 interview (for patients over 18) or Young DIVA-5 (for patients between 15 and 17) following a specialized ADHD-addiction(s) consultation;
* Indication for MPH treatment according to European recommendations (J. J. S. Kooij et al., 2019) and absence of contraindications (particularly cardiological);
* Presence of at least one comorbid addictive disorder (TUS and/or AC);
* Having given their consent to take part in the study;
* Being affiliated to the French social security system or benefiting from such a system.

Exclusion Criteria:

* Presence of disorders of the higher functions or difficulties in reading or writing the French language making it impossible to collect data;
* Pregnant or breast-feeding woman;
* Person deprived of liberty;
* Person under compulsory psychiatric care;
* Participation in another interventional research protocol involving another psychotherapeutic or pharmacological intervention that may have an impact on clinical outcome;
* Guardianship or safeguard of justice.
Personalized Theratyping Trial

The purpose of this study is to explore the use of off-label CFTR modulators that may affect CFTR function in patients with CFTR mutations that are not currently approved for these drugs.

The purpose of this study is to explore the use of off-label CFTR modulators that may affect CFTR function in patients with CFTR mutations that are not currently approved for these drugs. Symdeko (Tezacaftor/Ivacaftor), Orkambi (Ivacaftor and Lumacaftor), correctors of CFTR misfolding and Kalydeco (Ivacaftor), a potentiator of abnormal CFTR gating, will be explored as a treatment for patients with other CF mutations than those currently approved. Patients who have a mutation that responds to a CFTR corrector from in vitro study will be given Symdeko, or Orkambi, depending on the in vitro response pattern. Patients who have mutation response to a potentiator of CFTR function will be given Ivacaftor monotherapy. Patients with a mutation equivalent to wild type will be given Ivacaftor. If the patient is 6-12 years old, we will only study Orkambi or ivacaftor as symdeko is not yet FDA approved in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CF
* Age ≥6 y.o.
* CFTR mutation that may respond to approved correctors/potentiators in the opinion of the study investigators
* Informed Consent/Assent
* Stable CF pulmonary regimen

Exclusion Criteria:

* Exacerbation requiring antibiotic or steroids for \>28 days before trial entry
* Ongoing participation in a CFTR modulator study
* Active smoking in the past 6 months
* History of solid organ transplant
* Any condition which precludes the use of CFTR modulators: e.g. advanced cirrhosis, End-stage Renal Disease (ESRD)
* Any condition that precludes the patient from participation in the opinion of the investigator
* Any meds that have significant drug-drug interactions or any other off label use of CFTR modulators
Systemic Effects After Local Injection of Platelet-rich Plasma

Objective Platelet-rich plasma (PRP) is widely utilized in the treatment of sports injuries with favorable outcomes. However, potential systemic effects after localized PRP injection are unclear at present.

Design: prospective randomized study Methods Twenty-four Taiwanese male athletes with tendinopathy were randomized into a PRP group (n = 13) or a saline group (n = 11).


Eligibility Criteria:
Inclusion Criteria

- Adult male athletes were diagnosed with tendinitis

Exclusion Criteria:

* Receive local injections and surgery within three months
* Systemic disease
* Diagnosis of anemia
Lenalidomide in Patients With Chronic Myelomonocytic Leukemia

In a phase I study the investigators plan to investigate safety and toxicity of lenalidomide in patients with Chronic Myelomonocytic Leukemia (CMML). A phase II study will be started once an optimal dose has been found. The primary endpoint will concern the efficacy of lenalidomide in patients with CMML according to the WHO diagnostic criteria.


Eligibility Criteria:
Inclusion Criteria:

1. CMML according to the WHO diagnostic criteria.
2. Understand and voluntarily sign an informed consent form.
3. Age \>=18 years at the time of signing the informed consent form.
4. Able to adhere to the study visit schedule and other protocol requirements.
5. All previous cancer therapy must have been discontinued at least 4 weeks prior to treatment in this study. Patients carrying a somatic mutation involving the platelet derived growth factor receptor beta (PDGFRB) can be included if standard treatment with imatinib failed.
6. ECOG performance status of \<= 2 at study entry.
7. Laboratory test results within these ranges:

   * Creatinine clearance \> 30ml/min
   * AST (SGOT) and ALT (SGPT) \<= 2.5 x ULN
8. Disease free of prior malignancies for \>= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
9. Female subjects of childbearing potential must:

   * Understand the study drug is expected to have a teratogenic risk
   * Agree to use two effective contraception
10. Male subjects must

    * Agree to use condoms
    * Agree not to donate semen
11. All subjects must

    * Agree to abstain from donating blood
    * Agree not to share study drug with another person

Exclusion Criteria:

1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
4. Use of any other experimental drug or therapy within 28 days of baseline.
5. Known hypersensitivity to thalidomide.
6. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
7. Any prior use of lenalidomide.
8. Concurrent use of other anti-cancer agents or treatments.
9. Known positive for HIV or infectious hepatitis, type A, B or C.
Metformin Efficacy and Safety in Epileptic Patients

The goal of this clinical trial is to Evaluating Metformin Efficacy and Safety when Co-administered with Antiepileptic Drugs in Patients with Seizures. The main question it aims to answer is:

* Does metformin have beneficial effect on epileptic patients?
* How metformin can affect epileptic patient's health?

Participants will be divided into 2 groups (control group and treatment group)

* Control group will receive standard treatment (levetiracetam \&/or sodium valproate).
* Treatment group will receive standard treatment (levetiracetam \&/or sodium valproate) + metformin


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 - 65 years old
* Obese and overweight patients with body mass index (BMI) ≥ 25.
* Diabetic \& non diabetic patients.

Exclusion Criteria:

* Patients with severe liver damage or kidney disease (eGFR below 45mL/min/1.73 m²).
* Patients having acute or chronic disease which may cause tissue hypoxia and increase the risk of lactic acidosis (e.g. cardiac/respiratory failure, recent myocardial infarction).
* Patients who are already taking metformin.
* Cancer patients.
* Pregnant or lactating women.
* Patients with known hypersensitivity to the drug.
Encouraging Positive Parenting Habits

This study evaluates the feasibility and preliminary impacts of a new parenting program consisting of a series of educational videos, automatically delivered via a popular texting platform. The program content for the feasibility study is focused on teaching parents strategies to better manage one of the commonly reported challenges that children face, a transition to a non-preferred activity. Parents with young children experiencing behavior difficulties with daily transition routines are invited to participate in the study.

This feasibility study employs a pre-post, open trial design with the primary aim to investigate the feasibility of the automated delivery of parenting educational materials via a widely used texting platform. The training videos demonstrate the applications of antecedent- and reinforcement-based behavior management techniques in a specific situation and encourage parents to build positive parenting habits. The program usability and satisfaction will be assessed through daily interactions of the participants with the program and post-program questionnaires. The study targets parents of children demonstrating behavioral difficulties managing everyday routines at home, while having difficulty accessing traditional forms of psychosocial treatment. In particular, children of ADHD often experience these difficulties, potential participants are informed that the program is for children demonstrating behaviors consistent with ADHD, and ADHD symptoms will be evaluated pre- and post-program participation, although the presence of the disorder will not be required for the program participation. The investigators expect parents to engage well in the program delivered via digital media. Based on the existing literature on the effectiveness of behavior parent training delivered in traditional in-person format, the investigators expect a moderate effect size in the pre-post measures of parenting practices and the child target behavior for this study.

Eligibility Criteria:
Inclusion Criteria:

* Parents of children aged from 4 to 10 years old
* Parents experiencing behavior difficulties with daily transition routines (parent-report).

Exclusion Criteria:

* Parents that do not have the children living with them at least 5 days per week every week;

  * While participating parents are informed that the program was developed for children demonstrating symptoms of ADHD, the low symptom number will not be used as an exclusion criteria.
Extension Study of Enteric-coated Mycophenolate Sodium With Short-term or no Steroid Use Compared With Enteric-coated Mycophenolate Sodium With Standard Steroid Therapy in de Novo Kidney Recipients

The objective of this study is to assess the long-term safety and tolerability of EC-MPS on the patients who completed the core study and wish to continue treatment on EC-MPS.


Eligibility Criteria:
Inclusion Criteria/ Exclusion Criteria

* All patients who completed the core study and who are still receiving the EC-MPS and wish continue treatment with EC-MPS and from whom written informed consent has been obtained

Other protocol-defined exclusion criteria may apply.
The Expression Profile of New Complement Components in Childhood Lupus Nephritis

The aim of this study was to evaluate whether C4d is a better biomarker and examine whether C4d plasma levels correlate with treatment response and C4d kidney deposition in systemic lupus erythematosus (SLE) with lupus nephritis (LN).

Evaluation of C4d in lupus nephritis in children C4d level difference in children with systemic lupus with and without renal affection C4d level in lupus nephritis at activity and after remission Detection of C4d deposition in renal tissue relation to disease activity

Eligibility Criteria:
Inclusion Criteria:

* This will include children and adolescents who fulfill the 2012 Systemic Lupus International Collaborating Clinics (SLICC)(10) classification criteria of SLE.

  * Inclusion Criteria:

    * Age younger than 18 years.
    * Active SLE with and without renal affection
    * Patients with biopsy proven LN according to ISN/RPS classification criteria of Lupus nephritis.

Exclusion Criteria:

* -Patients in remission.
The Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-387 Under Fed Condition

The purpose of this clinical trial is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-387 and D484 under fed condition in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults aged 19 to 55 years
2. Females must be menopause or surgical infertility
3. Signed informed consent form
4. Other inclusion criteria, as defined in the protocol

Exclusion Criteria:

1. History of clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
2. Clinical laboratory test values are outside the accepted normal range at Screening

   * aspartate aminotransferase(AST), alanine aminotransferase(ALT) \> 1.25 times the upper limit of the normal range
   * Total Bilirubin \> 1.5 times the upper limit of the normal range
   * creatine phosphokinase(CPK) \> 1.5 times the upper limit of the normal range
   * estimated Glomerular Filtration Rate(eGFR, MDRD\* formula) \< 60 mL/min/1.73m2 (\*MDRD: Modification of Diet in Renal Disease)
   * Positive reaction on following tests: Hepatitis B, Hepatitis C, human immunodeficiency virus(HIV) and syphilis
   * systolic blood pressure(SBP) ≥ 150 mmHg or \< 90 mmHg, diastolic blood pressure(DBP) \> 100 mmHg or \< 50 mmHg
3. Subject who smoke heavily or drink caffeine or alcohol continuously and who cannot discontinue smoking, caffeine or alcohol intake during hospitalization
4. Participated in a clinical trial within 90 days prior to 1st IP dosing
5. Not eligible to participate for the study at the discretion of Investigator
6. Other exclusive inclusion criteria, as defined in the protocol