cyrilzakka/clinical-trials huggingface dataset:
Implementation of Therapy Together With Early Childhood Intervention

The purpose of this project is to conduct a pilot hybrid type two implementation and efficacy study on Therapy Together with Early Childhood Intervention using an explanatory mixed methods approach to evaluate the efficacy and implementation of Therapy Together. Therapy Together is a parent led intensive pediatric constraint induced movement therapy (P-CIMT) program for young children (3 months-2 years 11 months) with unilateral cerebral palsy (UCP). The research team developed the Therapy Together program due to the lack of clinical uptake in use of CIMT with children with UCP, even though there is consistent and robust evidence that demonstrates a positive treatment effect with the intervention. Therapy Together is based on the evidence and active ingredients of P-CIMT with a primary focus on utility and translation of research to clinical practice.

The long-term research goal is to implement Therapy Together, a caregiver-led pediatric constraint induced movement therapy program we developed for infants and toddlers with unilateral cerebral palsy, within regular health care models globally. The objective of this proposal is to conduct a pilot study to evaluate the efficacy and implementation of the Therapy Together program within the State of Texas Early Childhood Intervention program by conducting a mixed method, hybrid type two implementation and efficacy study guided by the RE-AIM Framework focusing on reach, effectiveness, adoption, and implementation. The central hypothesis is that Therapy Together can be successfully implemented within the early intervention model resulting in clinically significant improvements in hand function, occupational performance, and development. The rationale for this hypothesis is that Therapy Together is an adapted version of an evidence-based intervention specifically developed for implementation within standard of care practice.

Eligibility Criteria:
Inclusion Criteria:

* Participants were children three months to two years and eleven months old who presented with asymmetric hand use with risk of developing cerebral palsy (CP) or have already been diagnosed with CP that present with unilateral upper limb impairment. Inclusion criteria were children who visually attended to objects, showed interest in them, and tried to reach for or grasp objects with their impaired upper extremity were included in the study.

Exclusion Criteria:

* Exclusion criteria were children with uncontrolled epilepsy, significant visual impairment, severe behavior problems or unable to complete assessment protocol were not included in the study.
Effects of Antidepressant on Postsynaptic Signal Transduction in Serotonergic System of Depressed Patients

The purpose of this study is to determine whether alteration of signal transduction components after antidepressant targeting, predict antidepressant responsiveness in advance before the appearance of the drug effects until 4\~6 weeks after drug administration, or represent the clinical status of depressed patients.

The purpose of this study is to determine whether antidepressants effect on signal transduction in peripheral lymphocyte and to determine whether the signaling differences between drug responders and nonresponders predict the antidepressant response or represent the clinical status of depressed patients.

Eligibility Criteria:
Inclusion Criteria:

1. met the Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-IV) criteria for MDD from the Department of Psychiatry, Sungkyunkwan University, Seoul, South Korea.
2. were 18 years of age or older, the existence of a unipolar major depressive episode as verified by DSM-III/IV criteria, at least 2 years after first episode onset, and agreement to informed consents

Exclusion Criteria:

* pregnancy
* significant medical conditions
* abnormal laboratory baseline values
* unstable psychiatric features (e.g, suicidal attempt)
* history of alcohol or drug dependence, seizure, neurological illness, or concomitant Axis I psychiatric disorder
Evaluation of Dyslipidemia Management After Statin and Ezetimibe Complex Treatment

This study is a large-scale, prospective, multi-site, and non-interventional observational study to observe the change and safety of dyslipidemia management status when administering statin+etimib complex drugs in patients with dyslipidemia.

All treatments, including drug administration and laboratory tests performed after administration of statin+etimib complex, are performed by the researcher's medical judgment regardless of the subject's participation in the study, and the information to be confirmed in this observational study is collected up to 24 weeks.

Data collection will begin after the date of signing the research contract, and the follow-up period for each study subject is from the registration date (Visit 1) to the 24th week (Visit 3).

To evaluate subjects' clinical performance in real world, we collect demographic information and medical treatment based on patient's medical records, previous dyslipidemia drug administration information, blood lipid tests and liver function tests conducted at the start date of statin+etimib compound administration and subsequent 24 weeks (± 8 weeks). In the case of safety-related information, such as abnormal cases, data shall be collected at any time during the 24-week follow-up period if there is a visit by the study subject according to daily treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Adult men and women aged 19 or older as of the time of the registered visit (Visit 1)
2. Patients with dyslipidemia who are planning to administer statin+ezetimib complex or who are administering dyslipidemia complex according to the researcher's medical judgment based on the permission of statin+ezetimib complex
3. A person who can understand the information provided to him or her and voluntarily sign a written consent form

Exclusion Criteria:

1. Patients who overreact to the main ingredients or components of the drug in the study
2. Patients with active liver disease or patients with continuously high serum aminotransferase levels with unknown cause
3. Patients with muscle disease.
4. Pregnant women or pregnant women and nursing mothers
5. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabortion
6. A person who is not permitted by administration of statin+etimib complex or who falls under prohibition of administration
7. In addition to the above, a person who has determined that the researcher is not suitable for participation in this observation study
Polycystic Ovary Syndrome and Liraglutide

The purpose of this study was to determine whether liraglutide is more effective than metformin in the treatment of obese women with newly diagnosed polycystic ovary syndrome (PCOS). We anticipated greater changes in body weight in patients treated with liraglutide than in those treated with metformin.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old to menopause
* polycystic ovary syndrome (NICHD criteria)
* BMI of 30 kg/m² or higher

Exclusion Criteria:

* type 1 or type 2 diabetes mellitus
* history of carcinoma
* Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
* personal or family history of MEN 2
* significant cardiovascular, kidney or hepatic disease
* the use of medications known or suspected to affect reproductive or metabolic functions
* the use of statins, within 90 days prior to study entry
The Silicone Study

To compare, through a randomized, multicenter surgical trial, the postoperative tamponade effectiveness of intraocular silicone oil with that of an intraocular long-acting gas (initially sulfur hexafluoride \[SF 6 \], later perfluoropropane \[C 3 F 8 \]) for the management of retinal detachment complicated by proliferative vitreoretinopathy (PVR), using vitrectomy and associated techniques.

To evaluate the ocular complications that result from the use of silicone oil and gas.

The treatment of retinal detachment complicated by PVR remains controversial. Although some cases are managed successfully by pars plana vitrectomy and with temporary tamponade provided by intraocular gas, others eventually redetach with this technique. Preliminary reports indicate that prolonged tamponade with liquid silicone results in improved anatomical success, but the eventual visual outcome may be prejudiced by silicone-related complications, particularly glaucoma and keratopathy. The addition of hydraulic reattachment by simultaneous fluid/gas exchange to vitrectomy surgery has proved to be an important development. Although complications are few with these procedures, subsequent redetachment is frequent.

The Silicone Study was a randomized trial to investigate the relative merits of silicone oil or gas as tamponade modalities. All study patients underwent vitrectomy and were randomized intraoperatively either to silicone oil or to gas. Two groups of eyes were entered into the study: eyes that had not had a prior vitrectomy (Group 1) and those that had undergone previous vitrectomy outside the study (Group 2).

A critical element in the study was a standardized surgical procedure for PVR. This surgical procedure, intended to relieve retinal traction with vitrectomy techniques, was followed by assessment of the relief provided by an intraocular air tamponade. The eye was randomized to silicone oil or gas only after completion of the entire surgical procedure to eliminate investigator bias that might develop through knowledge of the treatment modality. Patients were examined 5 to 14 days following the randomization and again at 1, 3, 6, 12, 18, 24, and 36 months after that date. Repeated surgery was permitted for either treatment modality. The Fundus Photograph Reading Center staff processed and analyzed photographs taken at all the clinics, graded the preoperative severity of PVR on the basis of baseline visit photographs, and confirmed the macular status at followup visits.

End points of the study were visual acuity of 5/200 or greater and macular reattachment for 6 months following the final surgical procedure. The successful outcomes and complication rates of the two modalities were compared.

Eligibility Criteria:
Eligibility criteria included but were not limited to PVR of Grade C-3 or greater according to the Retina Society Classification and visual acuity of light perception or better.
Selective Internal Radiotherapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Cholangiocellular Carcinoma (CCC).

Selective Internal Radiotherapy is superior to Transarterial Chemoembolisation for the treatment of intrahepatic cholangiocellular carcinoma (CCC).


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years
* Intrahepatic CCC, proven by histology or by typical morphology in cross sectional imaging and elevated tumor markers (CEA or CA 19-9)
* Tumor confined to the liver
* At least one measurable lesion in magnetic resonance imaging (MRI)
* Tumor load ≤ 50%
* Preserved liver function (Child Pugh A and B)
* ECOG performance status ≤2

Exclusion Criteria:

* Patients feasible for curative treatment (e.g. resection or local ablation)
* Previous TACE or SIRT
* Prior Chemotherapy
* Child Pugh stage C
* ECOG Performance Status \>1
* Tumor involvement \>50% of the liver
* Extrahepatic tumor
* Serum Bilirubin \>2.0 mg/dl; Serum Albumin 2.8 g/dl, Serum Creatinine \>2 mg/dl; Leukocytes \<3000/ml; Thrombocytes \<50000/ml
* Clinically apparent ascites (ascites only in CT/MRI is no exclusion criteria)
* Esophageal bleeding during the last 3 months
* Hepatic encephalopathy
* Transjugular intrahepatic portosystemic shunt (TIPS)
* Infiltration or occlusion of the main portal vein
* Hepatofugal blood flow in the portal vein
* Hepatopulmonary shunt ≥ 20% in the macroaggregated albumin scan (MAA-scan)
* Contraindications against angiography
* Pregnancy
Copeptin and Thirst: Possible Predictive Markers of Effectiveness of Bariatric Surgery?

Prospective, non-pharmacological, spontaneous, single-center, interventional study.

COPTBAR is a prospective, nonpharmacological spontaneous single-center interventional study.

Laboratory tests and imaging study (complete abdomen ultrasonography) for monitoring patients will be conducted in accordance with normal clinical practice. In addition, periodic copeptin assay will be performed. Each patient, within the study protocol, will be evaluated for 12 months; thereafter, each patient will fall under the follow-up visits provided by normal clinical practice and by Corporate Diagnostic Therapeutic Pathway (PDTA).

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 40 in the absence of comorbidities; BMI ≥ 35 associated with at least one comorbidity
* Age ≥ 18 and less than or equal to 65 years
* Written informed consent obtained

Exclusion Criteria:

Contraindications to bariatric surgery:

* severe psychiatric illness in the decompensation phase;
* drug or alcohol abuse;
* patient unwilling to follow periodic checkups and a dietary regimen pregnancy or lactation.

Factors that could alter ADH/copeptin:

* Obesity induced by other endocrinopathies or medications;
* Diabetes mellitus of any type;
* Malignant neoplasms or ongoing acute disease;
* Organ failure or chronic CNS and kidney disease;
* Hydro-electrolyte alterations;
* use of drugs that interfere with pituitary-adrenal axis, diuretics, anti-psychotics and psychopharmacological therapies, GLP1 receptor agonists, estro-progestin therapy.
A Bioavailability Study Comparing Modified-release Capsules and Immediate Release Capsules in Fed and Fasting Conditions

Part 1: The purpose of this study is to determine the pharmacokinetic profile of 4 different Extended/modified-release formulations and one immediate release formulation of AZD1446. In addition the food effect on AZD1446 pharmacokinetics will be investigated.

Part 2: To asses the safety and tolerability of the selected formulation(s) from part 1 in elderly healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 19 and 30 kg/m2
* Clinically normal findings on physical examination

Exclusion Criteria:

* History of any clinically significant disease or disorder
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* History or present symptoms or signs of severe allergy/hypersensitivity reactions including severe food allergy, as judged by the investigator
Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in Systemic Lupus Erythematosus (SLE) Patients With Corticosteroid Therapy and High Low-Density Lipoprotein (LDL) Cholesterol Level

Early statin therapy in SLE patients that have high cholesterol level and other atherosclerosis risk should reduce atherosclerosis and coronary artery events in later course of disease. By the way, statin is used in restricted groups of rheumatologists due to awareness of side effects; myositis and hepatitis, that are frequently found in SLE patients more so than other groups of atherosclerosis patients and reporting data of autoimmune diseases that occur after statin use.


Eligibility Criteria:
Inclusion Criteria:

* SLE patients that on prednisolone more than 30 mg/day
* Normal liver faction: AST and ALT \< 80 mg/dl
* Normal muscle enzyme : CPK \< 100 U/L
* LDL cholesterol level \> 100 mg/dl

Exclusion Criteria:

* Patients that was treated with pulse methylprednisolone or corticosteroid equivalent to prednisolone \> 1mg/kg/day at screening.
* Statin allergy
* On statin treatment before screening
* On cyclosporine, antifugal (azole group), antibiotics (macrolide group), rifampicin, warfarin, phenytoin
* Pregnancy
* Abnormal liver function: AST or ALT \> 80 mg/dl
* Abnormal muscle enzyme : CPK \> 300 U/L
A Safety & Effectiveness Study of Intravenous Anidulafungin With AmBisome® for Treatment of Invasive Aspergillosis (IA).

The combination of Anidulafungin plus AmBisome® may offer an improved outcome for patients treated for Invasive Aspergillosis (IA). The purpose of this study is to determine the safety and the clinical and microbiological effectiveness of anidulafungin plus AmBisome® in treated patients located in the United States, Europe, and South Africa.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of definite IA outside the pulmonary system or definite or probable pulmonary IA
* Life expectancy: greater than 72 hours

Exclusion Criteria:

* Pregnant female
* Hypersensitivity to anidulafungin or echinocandin therapy
* Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid
* Hypersensitivity to amphotericin B deoxycholate or any other constituents of AmBisome unless, in the opinion of the investigator, the benefit of therapy outweighs the risk.
* Aspergilloma-in the absence of invasive disease
* Abnormal blood chemistries:

Bilirubin \> 3 times the upper limit of normal; AST (aspartate aminotransferase) or ALT (alanine aminotransferase)\> 5 times the upper limit of normal

* Greater than five days of therapeutic doses of systemic therapy for the current Aspergillus-associated condition or a cumulative dose of more than 5 mg/Kg of amphotericin, more than 25 mg/Kg of a lipid formulation of amphotericin, or more than 2g of itraconazole for the current condition. Prophylactic use of azoles or amphotericin is acceptable.
* Less than 4 weeks since prior participation in an investigational drug or device study, with the exception of cytotoxic, antiretroviral agents and therapies for AIDS-related opportunistic infections.
Functional Change and Efficacy of Duloxetine in Patients With Co-Morbid Depression & Soft Tissue Discomfort Syndrome

The objective of this study is to determine the time course of duloxetine efficacy on the symptoms of Major Depressive Disorder (MDD)and on the symptoms of Soft Tissue Discomfort Syndrome(STDS) via use of 24-hour Actigraph™ measures.

We hypothesize that there will be a reduction in both MDD and STDS symptoms in MDD patients with co-morbid STDS symptoms. We further hypothesize that there will be a rapid improvement in functional outcome ratings and 24-hour activity in MDD patients with co-morbid STDS symptoms which may occur even before the antidepressant effect is observed.


Eligibility Criteria:
Inclusion Criteria:

* \> 17 years old
* All races and ethnicity
* DSM IV-TR Axis I diagnosis of MDD
* Co-morbid STDS
* Baseline 17-item Hamilton Depression Rating \> 13

Exclusion Criteria:

* Primary Axis I disorder other than MDD
* History of mania or psychosis
* Actively suicidal
* Required hospitalization
* A alcohol or substance abuse or dependence within the preceding 3 months
* Pregnant or nursing
* Unstable medical condition (other than STDS)
* Narrow-angle glaucoma
* Sensitivity to duloxetine, concurrent antidepressant, tranquilizer, or mood stabilizer use
* Hepatic or renal insufficiency
Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 2

Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes.

Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release.

Data on human subjects are sparse and controversial, especially in a long-term manner. We therefore conduct a cross-over study to assess metabolic response to sweetened vs. non-sweetened soft drinks, which are consumed over a period of 4 weeks.

Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes.

Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release.

Data on human subjects are sparse and controversial, especially in a long-term manner. We therefore conduct a cross-over study to assess metabolic response to sweetened vs. non-sweetened soft drinks, which are consumed over a period of 4 weeks. Metabolic assessment will be based on oral glucose tolerance tests.

Eligibility Criteria:
Inclusion Criteria:

* healthy

Exclusion Criteria:

* no metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease
Evaluating the Ability of Zoledronic Acid to Reduce the Rate of Subsequent Osteoporotic Fractures After a Hip Fracture

The purpose of this study is to evaluate whether zoledronic acid given once yearly for two years to men and women after surgical repair of a recent hip fracture will significantly reduce the rate of all re-occurring (new) osteoporotic fractures. All patients will receive vitamin D and calcium.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ages 50 years or older
* Must have a recent hip fracture repair in the past 90 days
* Must be able to walk with or without assistive device (for example, using a walker) prior to the hip fracture

Exclusion Criteria:

* Current bisphosphonate users such as aredia (pamidronate), didronel (etidronate), fosamax (alendronate), actonel (residronate), skelid (tiludronate)

Other protocol-defined inclusion/exclusion criteria may apply.
The Pivotal Study of the Aptus Endovascular AAA Repair System

A prospective, non-randomized, multi-center clinical study to evaluate the safety and effectiveness of the Aptus Endovascular AAA Repair System compared to an open surgical repair historical control group in the treatment of abdominal aortic aneurysms (AAA).

The historical group is the open surgical repair procedures (n=323) in the Lifeline Foundation (now American Vascular Association Foundation).

Eligibility Criteria:
Inclusion Criteria:

* Infrarenal AAA with a maximum diameter ≥ 4.5 cm.
* Infrarenal AAA with at least 12 mm length of non-aneurysmal proximal neck.
* Infrarenal AAA with a proximal neck internal diameter between 19-29 mm.
* Infrarenal AAA with an internal diameter at the aortic bifurcation ≥ 18 mm.
* Infrarenal AAA with an angle of ≤ 60° relative to the long axis of the aneurysm.
* Bilateral iliac artery distal fixation sites ≥ 10 mm in length.
* Bilateral iliac arteries with an internal diameter between 9 and 20 mm.
* Bilateral femoral/iliac arteries with morphology compatible with standard vascular access techniques and vessel size must accommodate a 16F (5.3 mm) or 18F (6.0 mm) delivery system.

Exclusion Criteria:

* Myocardial infarction within past 10 weeks.
* Active systemic infection.
* Ruptured or leaking AAA.
* Mycotic or inflammatory AAA.
* Genetic connective tissue disorders (e.g., Marfans or Ehlers-Danlos Syndromes).
* Concomitant TAA or thoracoabdominal aortic aneurysms.
* Requires emergent AAA surgery.
* Previous AAA repair.
* Patients with a body habitus that would prevent imaging required by the study.
* Patient has significant comorbid conditions that pose undue risk of general anesthesia or endovascular surgery.
* Patient requires additional planned major procedure at the time of AAA repair or within 30 days before or after AAA repair.
* Dialysis dependent renal failure or creatinine \> 2.5 mg/dL.
* Allergy to or intolerance of radiopaque contrast agents.
* Patients with a known sensitivity or allergy to implant materials.
* Patients who cannot discontinue oral anticoagulation or antiplatelet therapy at the time of the study procedure.
* Patients with history of bleeding diathesis or hypercoagulable condition.
* Patients with thrombus, calcification, and/or plaque ≥ 2mm in thickness and/or ≥ 50% (180°) continuous coverage of the vessel circumference in the intended seal zone.
* Patients with irregular shaped calcification and/or plaque that may compromise the fixation and sealing at the proximal or distal implantation sites.