cyrilzakka/clinical-trials huggingface dataset:
Hands and Hearts Together

Growing evidence demonstrates that secure attachment in childhood predicts children's healthy social, biological, and behavioral functioning, whereas insecure attachment predicts behavior problems and physiological dysregulation; thus, efforts to foster secure attachment are crucial for promoting the healthy development of children and families. This proposal describes a randomized controlled trial (RCT) of an innovative intervention program that can be widely implemented designed to foster children's secure attachment, promote healthy physiological regulation, and reduce the risk for behavior problems: The Circle of Security ® Parenting (COS-P) intervention. To this end, investigators will conduct an RCT with 249 parent-child dyads enrolled or are eligible but not yet enrolled in two diverse Early Head Start (EHS) programs.


Eligibility Criteria:
Inclusion Criteria:

* Parents whose children (age 8 to 36 months) are enrolled or are eligible to be enrolled in Harrisburg PA and Lehigh Valley PA Early Head Start programs

Exclusion Criteria:

* Parents who are not sufficiently fluent in the language in which COS-P intervention will be conducted (Spanish or English)
Safety and Efficacy of Low Dosage of Terazosin in Subjects Undergoing Carotid Artery Stenting

The purpose of this study is to assess the safety and efficacy of low dosage of Terazosin in Carotid Artery Stenting


Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic or asymptomatic carotid artery stenosis. In symptomatic patients the degree of stenosis should more than 50% (Based on NASCET Criteria), in asymptomatic patients the degree of stenosis should more than 70% (Based on NASCET Criteria);
2. Tolerance to any of the study medications, including TZ, clopidogrel, aspirin and statins;
3. Hypertensive patients with or without oral antihypertensive drugs
4. Can cooperate with and complete brain MRI examination;
5. Stable vital signs, cardiopulmonary, liver and kidney function was no obvious abnormalities;
6. Has a negative pregnancy test within 7 days before randomization and no childbearing potential;
7. Stable vital sign, normal renal and hepatic functions;
8. Informed consent.

Exclusion Criteria:

1. Evolving stroke;
2. Hemorrhagic tendency；
3. Severe dementia or Prior major ipsilateral stroke, if likely to confound study endpoints;
4. Chronic atrial fibrillation or any other Cardiogenic emboli source disease;
5. Myocardial infarction within previous 30 days;
6. Spontaneous Intracerebral Hemorrhage within the past 180 days, Hemorrhagic conversion of an ischemic stroke within the past 60 days or recent (\<7 days) large area cerebral infarction has a hemorrhagic conversion tendence;
7. Any conditions that hampers proper angiographic assessment or makes percutaneous arterial access unsafe;
8. High risk candidates of CAS defined as the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST);
9. Thiazides taken within 14 days before randomization;
10. Participating in any other clinical trial that has not completed the required protocol follow-up period;
Real-World Registry Study on Clinical Analgesic Effect of Acetylaconitine Tablets

1. To observe the clinical analgesic effect, safety and adverse reactions of acetylaconitine.
2. To study and analyze the main influencing factors of the acetylaconitine tablets.

The outpatients/inpatients meeting the criteria are included into this study after signing the Informed Consent Form. The patients received 5 visits in total, which take place after the patients are included into the real-world study, on the 3rd day after enrollment and at the 1st, 4th, 8th and 12th weeks thereafter, in the form of outpatient follow-up, telephone follow-up and APP follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic pain \> 1 month and VAS \> 40 mm Patients who can take the acetylaconitine tablets orally

Exclusion Criteria:

* Patients who cannot communicate or receive follow-up Patients allergic to acetylaconitine Patients who have taken the acetylaconitine drugs orally
Improvement of Fluid Balance in Patients Undergoing Surgery of the Colon and Rectum

58 patients undergoing surgery of the large bowel are divided into two groups. The control group will receive standard care. The intervention group will receive standard care plus optimization of the blood circulation based on in- or decrease of the output of the heart. Between group differences are measured primarily by markers of intestinal damage in plasma and urine. Also CO2 pressure in the stomach lumen is measured (reflecting blood supply to the gut).

The investigators hypothesize that the intervention group will have less intestinal damage, improved blood supply to the bowel and improved recovery of the operation compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing elective colorectal surgery with anastomosis;
* Minimum age 18 years;
* Giving informed consent.

Exclusion Criteria:

* Other causes of intestinal damage: eg. IBD, occlusive disease;
* Steroid use;
* Esophageal varices and other esophageal disease;
* Aortic valve disease.
Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Versus Vehicle in Patients With Moderate to Severe Dry Eye Syndrome

A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion versus Vehicle in Patients with Moderate to Severe Dry Eye Syndrome


Eligibility Criteria:
Inclusion Criteria:

* Males or females 18 years of age or greater.
* At baseline, moderate to severe dry eye condition persisting despite conventional management.

Exclusion Criteria:

* Presence or history of any systemic or ocular disorder or condition, including ocular surgery, trauma or disease that could possibly interfere with the interpretation of study results.
* Any relevant ocular anomaly interfering with the ocular surface, including post radiation keratitis, Stevens-Johnson syndrome, corneal ulcer history or concomitant corneal ulcer of infectious origin, etc.
* Any other ocular diseases requiring topical ocular treatment during the study period.
* Patient who has participated in a clinical trial with a new active substance during the past month before study entry.
* Participation in another clinical study at the same time as the present study.
Cidofovir in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer Who Are Receiving Chemotherapy and Radiation Therapy

RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs such as cidofovir may make tumor cells more sensitive to radiation therapy. Giving cidofovir together with radiation therapy and chemotherapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of cidofovir in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer who are receiving chemotherapy together with radiation therapy.

OBJECTIVES:

Primary

* Determine the maximum tolerated dose of cidofovir when given as a radiosensitizer in patients with stage IB-IVA cervical cancer undergoing concurrent chemoradiotherapy.

Secondary

* Evaluate the influence of treatment on the expression of mRNA codons in HPV oncoproteins E6 and E7.
* Determine the rate of local control.

OUTLINE: This is a dose-escalation study of cidofovir.

Patients receive cidofovir IV weekly for 2 weeks prior to beginning radiotherapy and then once biweekly during radiotherapy. Patients undergo external pelvic radiotherapy for 5 weeks. Beginning ≤ 2 weeks later, patients undergo utero-vaginal brachytherapy. Some patients may also undergo a second course of external radiotherapy to the parametrium and/or lymph nodes ≤ 3 days after brachytherapy. Patients also receive concurrent carboplatin IV once weekly during external radiotherapy and brachytherapy.

Biological expression of HPV oncoproteins E6 and E7 is analyzed during treatment.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of squamous cell carcinoma or adenocarcinoma of the cervix

  * Stage IB2 (\> 4 cm), II, III, or IVA disease
* No lumbo-aortic metastasis
* Initial tumor must be HPV-positive

PATIENT CHARACTERISTICS:

* WHO performance status 0-1
* Life expectancy \> 3 months
* ANC \> 2,000/mm\^3
* Platelet count \> 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL
* Transaminases \< 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase \< 1.5 times ULN
* Bilirubin \< 1.5 times ULN
* Creatinine \< 1.5 times ULN
* Creatinine clearance ≥ 55 mL/min
* Proteinuria \< 2 g/L
* Not pregnant
* Negative pregnancy test
* No renal disease
* No concurrent active infection
* No prior or concurrent psychiatric illness
* No history of cancer except for basal cell carcinoma
* No other active infection or serious illness that would prevent the patient from receiving study treatment
* No known psychological, familial, social, or geographic reason that would preclude clinical monitoring

PRIOR CONCURRENT THERAPY:

* No prior radiotherapy or chemotherapy
* More than 30 days since prior experimental drugs
Assist Control Versus Pressure Support Modes for Domiciliary Noninvasive Ventilation in Chronic Respiratory Failure

Noninvasive ventilation is a therapeutic option in some patients with chronic respiratory failure. Patients usually ventilate during nightime with a domiciliary ventilator either in assist control or in pressure support mode.

The aim of this study is to compare the clinical efficacy and the tolerance of assist control and pressure support modes during domiciliary noninvasive ventilation in patients with chronic respiratory failure.

The aim of this study is to compare the clinical efficacy and the tolerance of assist control and pressure support modes during domiciliary noninvasive ventilation in patients with chronic respiratory failure.

Eligibility Criteria:
Inclusion Criteria:

* Chronic respiratory failure
* Clinical symptoms of chronic alveolar hypoventilation
* PaCO2 ≥ 45 mmHg in case of restrictive pulmonary disorder or PaCO2 ≥ 55 mmHg in case or obstructive pulmonary disorder

Exclusion Criteria:

* Clinical exacerbation during the three previous weeks
* Previous treatment by domiciliary non invasive ventilation
* Previous treatment by non invasive ventilation for acute respiratory failure during the 3 previous months
* Bronchiectasis
* Duchenne muscular dystrophy
* Amyotrophic lateral sclerosis
Exploratory Study on the Safety, Tolerability, and Pharmacodynamics of IMB-1018972 in Subjects With Angina Due to Obstructive Coronary Artery Disease (IMPROVE-Ischemia)

The purpose of this study is to assess the safety and tolerability of IMB-1018972 in subjects with obstructive CAD and inducible ischemia.


Eligibility Criteria:
Inclusion Criteria:

* Documented history of stable angina (CCS grading I-III) or anginal equivalent for ≥1 month prior to screening
* Ability to safely abstain from beta blockers for 48 hours prior to echo examinations in the opinion of the Investigator
* Preserved LV systolic function, defined as LVEF≥50% by any imaging modality
* Obstructive CAD and recent evidence of stress-induced myocardial ischemia

Exclusion Criteria:

* Women of childbearing potential or who are currently pregnant or breast-feeding
* Clinically indicated for coronary revascularization (PCI/CABG) at time of screening or clinically significant LMS or proximal LAD stenosis likely to warrant revascularization during the study period in the opinion of the investigator.
* Type 1 insulin dependent diabetes mellitus (IDDM)
* Presence of pacemaker, cardiac resynchronization therapy and/or implantable cardioverter defibrillator
* Severe or clinically significant valvular heart disease
* Clinically significant concurrent condition which could prevent the patient from performing any of the protocol-specified assessments, represent a safety concern if the patient participates in the trial or could confound trial assessments of safety or tolerability
P. Falciparum Infection Dynamics and Transmission to Inform Elimination (INDIE-1a)

In the current randomized trial, the investigators will test the ability of two experimental approaches to malaria infection management to reduce malaria transmission potential. Compounds in Saponé, Burkina Faso, will be randomized to 1 of 3 study arms: arm 1 - current standard of care with passively monitored malaria infections; arm 2 - standard of care plus enhanced community case management (CCM), comprising active weekly screening for fever, and detection and treatment of infections in fever positive individuals using conventional rapid diagnostic tests (RDTs); or arm 3 - standard of care and enhanced CCM, plus monthly screening and treatment (MSAT) using RDTs. The study will be conducted over approximately 18 months covering two high transmission seasons and the intervening dry season


Eligibility Criteria:
Inclusion Criteria:

1. Participants should be permanent residents of the compound
2. Participants should be willing to participate in repeated assessments of health and infection status and willing to donate a maximum of 37mL of blood (children \<10 years of age) or 52mL of blood (older individuals) during an 18-month period

Exclusion Criteria:

1. Any (chronic) illness that would affect with study participation
2. Pre-existing severe chronic health conditions
3. Current participation in malaria vaccine trials or participation in such trials in the last 2 years
4. History of intolerance to artemether-lumefantrine
Comparing Artificial Intelligence for Assisted Diagnosis of Diabetic Retinopathy

This study plans to compare the accuracy of artificial intelligence (AI)-assisted fundus images with other ophthalmic devices such as optical coherence tomography (OCT) and fundus fluorescence angiography (FFA) in the diagnosis of diabetic retinopathy and diabetic macular edema.

This study plans to compare the accuracy of artificial intelligence (AI)-assisted fundus images with other ophthalmic devices such as optical coherence tomography (OCT) and fundus fluorescence angiography (FFA) in the diagnosis of diabetic retinopathy and diabetic macular edema.

This study was conducted as a prospective study. Participants meeting eligibility criteria will be recruited from sites staffed by trained photographers. After assessing eligibility and obtaining informed consent, fundus photographs will be taken using a non-dilated fundus camera. And optical coherence tomography or fundus fluorescence angiography will be performed.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnostic for diabetes: Type 1 diabetes of a lest 5 years of evolution; or Type 2 diabetes;
2. Obtaining informed consent;
3. Patient age 18 or above.

Exclusion Criteria:

1. Patients under 18 years of age;
2. Failure to Obtain informed consent;
3. Presence of other retinal diseases;
4. A patient who has already undergone the treatment.
High vs Standard Energy Children's Drink Study

This study is a pilot trial investigating the effects of a high energy drink for children, in comparison to standard energy drink for children.

A four week, multi-centre, randomised controlled trial investigating the effects of a high energy density, low volume oral nutritional supplement versus standard energy density oral nutritional supplements in children aged 1-12yrs old requiring nutritional support. Fifty eligible children will be recruited and randomised to receive either the high energy density oral nutritional supplement or the standard energy density oral nutritional supplement for four weeks. The primary outcome is nutrient intake, with secondary outcomes of compliance, tolerance, acceptability, anthropometry and safety.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Aged 1-12yrs
* Faltering growth and/or requiring oral nutritional supplements to meet nutritional requirements
* Expected to receive at least one bottle of the study product per day
* Able to take study products orally during the study period
* Written informed consent from parent/carer

Exclusion Criteria:

* Requirement for 100% of their nutrition via enteral tube and/or parenteral feeding.
* Children with major hepatic or renal dysfunction
* Children with galactosaemia or severe lactose intolerance
* Requirement for elemental or semi-elemental feeds
* Investigator concern around willingness/ability of child/parent/carer to comply with protocol requirements
* Participation in other studies within 2 weeks of study
A New Pelvic Osteotomy Method for Open Reduction

Developmental dysplasia of the hip (DDH) was one of the most common hip disorders disease in children. Pemberton osteotomy (PO) was one of the most widely used by the pediatric orthopedic surgeons. In our clinical work, the investigators found some defect the operation procedure. When the surgeons were not familiar to the PO, it may injured the triradiate cartilage or easily be absorbable of the distal iliac. Here, the investigators found a new pelvic osteotomy just from the inner "L shaped" iliac osteotomy (ILSO) to treat DDH. This approach was in a visible part of the sciatic notch and not presumed to be in the ischium, completely out of sight. Comparing to the PO method, the investigators' operation method was easy to master and had less complications.


Eligibility Criteria:
Inclusion Criteria:

* over two years old
* open reduction and acetabular osteotomy
* diagnosed as developmental dysplasia of the hip

Exclusion Criteria:

* a previous history of DDH surgery
* teratologic dislocations
* cerebral palsy
* other spastic or neuromuscular disease
Automated Identification of Psychogenic Nonepileptic Seizures

A retrospective validation study of a post-processing method intended to identify psychogenic nonepileptic seizures

This is a validation study of a post-processing method intended to identify psychogenic nonepileptic seizures by analysis of surface electromyographic (sEMG) artifact previously recorded during routine video-electroencephalographic (vEEG) monitoring

Eligibility Criteria:
Inclusion Criteria:

A subject will be eligible for inclusion in this study if the following criteria apply.

* Subject was previously admitted to the Medical University of South Carolina for inpatient vEEG monitoring in the MUSC Epilepsy Monitoring Unit and at least one PNES was recorded during that admission.
* Male or female between the ages of 2-99
* Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments

Exclusion Criteria:

* No exclusion criteria have been established for this study.
A Trial of SHR0302Base in Patients With Vitiligo

The purpose of this study is to evaluate the efficacy and safety of SHR0302Base in participants with nonsegmental vitiligo.


Eligibility Criteria:
Inclusion Criteria:

1. Clinically diagnosis of non-segmental vitiligo.
2. The disease has been stable for more than 3 months (90 days) (stable disease is defined as no expansion of the original lesion and no new lesions).
3. Subjects and their partners do not plan to have children, do not donate sperm/eggs, and voluntarily use highly effective contraception during the study period until 6 months (female subjects) or 3 months (male subjects) after dosing. Female subjects must have a negative serum pregnancy test and be non-lactating.

Exclusion Criteria:

1. Subjects diagnosed with segmental, mixed or undifferentiated vitiligo; Or previously diagnosed with other skin pigmentation disorders (except nevus halos).
2. Conditions at baseline that would interfere with evaluation of vitiligo.
3. Participants who have used skin bleaching treatments for past treatment of vitiligo or other pigmented areas.
4. Use of protocol-defined treatments within the indicated washout period before baseline.
A Study to Test the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder

The study is intended to test efficacy, safety and tolerability of two doses of once daily (qd) Mirabegron against placebo to treat patients with symptoms of overactive bladder.


Eligibility Criteria:
Inclusion Criteria:

* Patient is willing and able to complete the micturition diary and questionnaires correctly
* Patient has symptoms of overactive bladder (OAB) for ≥ 3 months
* Patient must experience frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period
* Patient must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence during the 3-day micturition diary period

Exclusion Criteria:

* Patient is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control
* Patient has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
* Patient is using medications intended to treat OAB
* Patient has an indwelling catheter or practices intermittent self-catheterization
* Patient has diabetic neuropathy
* Patient has evidence of urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
* Patient receives non-drug treatment including electro-stimulation therapy
* Patient has severe hypertension
* Patient has participated in a clinical study within 30 days, or had participated in any previous study with mirabegron
* Patient had an average total daily urine volume \> 3000 mL as recorded in the 3-day micturition diary period
* Patient has serum creatinine of \>150 μmol/L, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2x upper limit of normal range (ULN), or gamma-glutamyl transpeptidase (γ-GT) \> 3x ULN
* Patient has a clinically significant abnormal electrocardiogram (ECG)
Effect of Hepatitis C Clearance on Insulin Resistance

Chronic hepatitis C infection has been linked to insulin resistance, which is the essential component of metabolic syndrome and type 2 diabetes mellitus. Resistin; an adipokine, has been demonstrated to stimulate the secretion of several inflammatory factors known to play a role in the induction of insulin resistance. we investigated the changes in insulin resistance after hepatitis C clearance in the era of direct antivirals.

the link between hepatitis C infection and insulin resistance has been established. Insuli resistance has been linked to poor response to interferon based therapy. recently, direct acting antiviral drugs are approved for hepatitis C elimination with high potency and safety. The aim of the study is to: 1. Determine the prevalence of insulin resistance among non-diabetic patients with chronic HCV infection. 2. Explore the impact of treatment with DAAs on insulin resistance among chronic HCV infected patients. 3. Investigate the role of insulin resistance as a potential prognostic factor for the response to DAAs. 4. Explore the utility of resistin as a potential biomarker IR among HCV infected patients.

Eligibility Criteria:
Inclusion Criteria:

* Hepatitis C treatment-naïve;
* Non-diabetic patients.

Exclusion Criteria:

* Seropositivity for hepatitis B virus infection;
* Diabetes mellitus;
* Bbody mass index ≥ 30 Kg/M\*2;
* History of alcohol consumption;
* Endocrinopathies that may affect the glycemic homeostasis;
* Other known causes of chronic liver disease; Hepatic decompensation \[defined as history of gastrointestinal bleeding (melena and /or hematemesis), jaundice, coagulopathy, hepatic encephalopathy, and/or ascites\]; bleeding diathesis;
* Connective tissue diseases;
* Autoimmune diseases;
* Cardiac, respiratory or renal disease.
* Patient receiving immuno-modulatory therapy or drugs that affect the blood glucose levels such as steroids or beta-blockers.