cyrilzakka/clinical-trials huggingface dataset:
Predictability of Distalization and Derotation of the Carriere Motion Appliance.

To analyze the distalization or distal tooth displacement and derotation angle produced by Carriere Motion Appliance® (CMA) by using a repeatable and reproducible measurement digital technique.

15 patients with Class II molar and canine relationship were submitted to orthodontic treatment with CMA. All patients were exposed preoperatively (STL1) and postoperatively (STL2) to a digital impression and afterwards were uploaded into a specific cephalometric software to allow the automatic mesh networks alignment of the STL digital files. Subsequently, the distal tooth displacement of upper canines and first upper molars and also the derotation angle of first upper molars were measured. The repeatability and reproducibility were analyzed by Gage R\&R statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Growing patients
* Late mixed dentition or permanent dentition
* Fully erupted definitive molars
* No history of previous orthodontic treatment
* Complete pre- and post-treatment records (digital study models)
* Dental Class II relationship.

Exclusion Criteria:

* Permanent dentition
* Adults
* Dental Class I, III
Study of Milademetan in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

This is a Phase 1, multicenter, open-label study to evaluate safety, tolerability and pharmacokinetics of milademetan in Japanese patients with relapsed or refractory acute myeloid leukemia. The milademetan initial dose will be Level 1: 90 mg. No increase in the milademetan dose will be made in the same participant. Dose-limiting toxicity associated with milademetan occurring at each level will be assessed, and the maximum tolerated dose (MTD) will be decided using a modified continuous reassessment method (mCRM).


Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory AML
* AML for which no standard treatment is available
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2

Exclusion Criteria:

* Acute Promyelocytic Leukemia
* Chronic myelogenous leukemia in blast crisis (BCR-ABL fusion gene positive)
* Presence of central nervous system involvement of leukemia or a history of primary central nervous system leukemia
Effect of aSpirin Versus CilOstazol for Inhibition of Antiplatelet aggRegaTion in Type 2 DM Patients

This study evaluates the more suitable treatment for the prevention of vascular complications in diabetes patents who were at high cardiovascular risk group by comparing the platelet aggregation inhibitory effect of aspirin and cilostazol.

Diabetes is a dangerous disease with high risk of vascular complications. Thus, to prevent these vascular complication, antithrombotic drug may be administered. Representative antithrombotic agents are aspirin and cilostazol. However, recent studies suggested that aspirin did not have sufficient effect to prevent vascular complications of diabetes. For that reason, it have been reported that antithrombotic effects of aspirin were falling in diabetes patients, so-called 'aspirin resistance.

On the other hand, cilostazol used as the control drug inhibits atherosclerosis in diabetes patients in the studies of Asia including Korea, and it is effective to inhibit the risk of various cardiovascular disease. Therefore, cilostazol is likely to use drugs as substitute for aspirin therapy.

Eligibility Criteria:
Inclusion Criteria:

* Who have one more following risk factor:

  * Family history of cardiovascular disease
  * Hypertension
  * Smoking History
  * Dyslipidemia
  * Albuminuria
* Who do not have high risk of bleeding
* Who stop taking Cilostazol or Aspirin before randomized period 1months or
* Who have never taken the drugs

Exclusion Criteria:

* Type 1 diabetes mellitus, gestational diabetes
* Who with history of macrovascular complication including cardiovascular disease, cerebrovascular disease and peripheral vascular disease
Epidemiological Data on Pain

The ALGOBASES project is an observational epidemiological study of pain through the collection of pain evaluation questionnaires and information with the aim of creating a descriptive "pain" evaluation in all patients who need to benefit from orthopedic, thoracic or gynecological surgery. The painful symptomatology will thus be evaluated in all its dimensions (demographic data, physical, psychological, socio-cultural components) and linked to the pathology justifying the specialized care. It is planned to collect the same data at each subsequent event in order to allow the determination of predictive factors, pain trajectories according to the type of surgery, and the profile of subjects at risk of acute or chronic postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 17 years old Patient needing orthopedic surgery Patient needing gynecological surgery Patient needing thoracic surgery Patient who has given written consent to participate in the trial. Socially insured patient Patient willing to comply with all study procedures and study duration

Exclusion Criteria:

* Age under 18 years old
* Non-communicating patient
* Patient does not understand French
* Patient without social protection
* Patient refusing to participate
An Observational Study in Patients Using NovoMix® 30 or Levemir® for Treatment of Type 1 or Type 2 Diabetes Mellitus

This trial is conducted in Europe. The aim of this trial is to investigate efficacy and safety of NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) in subjects with type 1 or 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Macedonian people with diabetes mellitus (Type 1 or Type 2)
Trial of Methyl B12 on Behavioral and Metabolic Measures in Children With Autism

The purpose of this study is to determine whether the supplement Methyl B12 is effective in treating some of the symptoms of Autism.

Autism is a complex neurodevelopmental disorder with early childhood onset characterized by impairments in communication, social interaction, and repetitive behavior. Due to the lack of known treatments for autism, many parents seek complementary and alternative medical (CAM) therapies hoping to help their affected child. Methylcobalamin (methyl B12) is a commonly used CAM treatment that has anecdotal reports of remarkable clinical improvements with few side effects. Prior studies have found that children with autism have deficiencies in key metabolites and antioxidants which can be caused by methyl B12 deficiency; additional studies have shown that methyl B12 normalizes deficiencies in these metabolites and antioxidants. Based on these reports, a pilot study was conducted at UC Davis on the effect of methyl B12 on the behavioral and metabolic measures in children with autism. The preliminary results of 29 subjects revealed a subgroup of 9 responders to clinical behavior assessments. These responders also demonstrated significant improvement on the plasma measures of antioxidant capacity, suggesting methyl B12 improves symptoms in a subgroup of children with autism by increasing key antioxidants. The current study will have an 8 week double blind design with 50 subjects, designed to evaluate improvements from methyl B12 by using behavioral assessments and analysis of specific metabolites in the subjects' blood. This study will determine whether methyl B12 will lead to benefits in any of the core features of autism, and will examine metabolic changes with the hope of potentially identifying a biomarker for treatment response in a subgroup of subjects.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of DSM IV defined autism and meets cut off on Autism Diagnostic Inventory-Revised (ADI-R) and/or the Autism Diagnostic Observation Scale (ADOS)
* Age 3 through 7 years
* IQ of 50 or above
* Parental agreement to continue present dietary, behavioral or psychotropic drug treatment but not change treatment during 8 week intervention
* Willingness to have blood drawn, without the use of a sedative prescription from the study doctor

Exclusion Criteria:

* Bleeding disorder
* Cancer
* Seizure disorder
* Fragile X or other known genetic cause of autism
* Perinatal brain injury (i.e.: cerebral palsy)
* Other serious medical illnesses
* Current use of any B12 supplement
Video Capsule Endoscopy Versus Colonoscopy in Patients With Melena and Negative Upper Endoscopy

Acute gastrointestinal bleeding is a common medical problem. When patients with gastrointestinal bleeding present with melena (dark, tarry stool) the blood loss is usually originating in the upper gastrointestinal tract (esophagus, stomach or duodenum) and first step in evaluating the patient is an upper endoscopy; which allows direct visualization of the esophagus, stomach and duodenum. However, the cause of bleeding is located in the small bowel or colon in 20-30% of patients who present with melena. Traditionally colonoscopy has been the next test preformed if upper endoscopy does not identify the cause of melena/ gastrointestinal bleeding, however less than 25% of patients who present with melena have bleeding originating in the colon, and the remainder of patients have bleeding originating in the small intestine, which can only be fully evaluated with video capsule endoscopy (a pill camera which is swallowed and takes pictures while it travels thought the small bowel and colon). Currently patients only undergo video capsule endoscopy if colonoscopy does not identify the cause of bleeding. The investigators are preforming a randomized study which seeks to determine if colonoscopy or video capsule endoscopy is a better way to identify the cause of gastrointestinal bleeding in patients who present with melena and have normal findings on upper endoscopy. To do this the investigators will enroll patients who present with melena prior to their upper endoscopy and if the cause of bleeding is not identified at that time patients will be randomized to video capsule endoscopy (with the capsule being placed into the small bowel during the upper endoscopy) or next day colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

• Inpatients \>18 years of age presenting with lower gastrointestinal bleeding and have melenic stool

Exclusion Criteria:

* Unable to provide written informed consent
* A probable bleeding source is identified on upper endoscopy
* Pregnancy or lactation
* Swallowing Disorder
* Unable to tolerate sedation or anesthesia due to medical co-morbidities
* Uncorrected coagulopathy (platelet count \<50,000, INR\> 2, PTT\> 2x upper limit of normal)
* Known or suspected gastrointestinal obstruction or stricture
* Cardiac pacemaker or other implanted electromedical device
* Contraindication to bowel preparation
Colchicine to Reduce Cardiac Injury in COVID-19 (COLHEART-19)

Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care per UCLA treating physicians versus current care per UCLA treating physicians alone (control arm). Importantly, this adaptive trial design allows for patients in either study arm to receive other investigational drugs for COVID-19 as new science emerges.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed COVID-19 infection by polymerase chain reaction
* Cardiac injury, including any of the following:

  * Elevated troponin level
  * Elevated B-type natriuretic peptide (BNP) level
  * New ischemic or arrhythmogenic changes on ECG/telemetry
  * New decrease in left ventricular ejection fraction (LVEF) or new pericardial effusion on echocardiogram
* Able to provide informed consent

Exclusion Criteria:

* Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use 2 forms of contraception, which includes:

  * Intrauterine devices (IUD), contraceptive implants, or tubal sterilization
  * Hormone methods with a barrier method
  * Two barrier methods
  * If a partner's vasectomy is the chosen method of contraception, a hormone or barrier method must also be used in conjunction
* Co-administration of Cytochrome P450 3A4 (CYPA3A4) and P-glycoprotein (P-gp) transport system inhibitors
* Concurrent use of strong CYP3A4 or P-gp inhibitors in patients with renal or hepatic impairment;
* Severe hematologic or neuromuscular disorders
* Severe renal impairment with concomitant hepatic impairment
The Effect of Acupuncture in Treating Chronic Low-back Pain

The purpose of this study is to evaluate the efficiency of acupuncture in treating chronic low-back pain

We want to know if the Yaotong points penetration or standardized acupuncture mode are more effective than medical care alone for CLBP; and if Yaotong points penetration is more effective than standardized acupuncture.

Eligibility Criteria:
Inclusion Criteria:

* with CLBP
* without taking any other medication for the treatment of CLBP in at least 2 last weeks;
* aged from 18 to 50 years;
* without conflict to the written, informed consent signed prior to the enrollment.

Exclusion Criteria:

* pathological causes of chronic back pain (such as fractures, cancer, spinal stenosis and infections);
* complicated back problems (such as scoliologic \>40° curvature, chronic spondylitis, sciatica, prior back surgery and other medicolegal issues);
* with contraindications for acupuncture (e.g., cardiac pacemakers, coagulation disfunctions, being in pregnancy, seizure disorder);
* conditions making treatment difficult (e.g., paralysis, psychoses);
* conditions that might confound treatment effects or interpretation of results (e.g., severe fibromyalgia, rheumatoid arthritis, concurrent care from other providers);
* previous acupuncture treatment for any condition.
Home Care for the Patient With Heart Failure: Can Caregiver Education Prevent Hospital Admissions?

The study is aimed to evaluate if the education of the caregiver is able to reduce hospital admissions of patients with heart failure assisted at home.

The primary objective of the study is to assess whether an educational intervention aimed at increasing the caregiver's skills is able to reduce hospital admissions for any cause in patients with heart failure assisted at home.

The General Practitioners who agree to participate are randomized in two groups: a) intervention group, whose patients are assisted in accordance with the procedures established by the project; b) control group, whose patients continue to be assisted in the usual modality.

The intervention consists of an educational session for each caregiver aimed at improving his ability to recognize early symptoms and signs of heart failure.

Eligibility Criteria:
Inclusion Criteria:

* adults of any age and gender in NYHA (New York Heart Association) classes II, III, IV, assisted exclusively at home;
* willingness and ability to sign a written informed consent;
* presence of a person who cared for the patient in a prevalent and regular way;
* willingness of the caregiver to attend a training meeting.
Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure

To further characterize the transfer potential of marketed testosterone gel and new 1.62% formulation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers, with a BMI 20-35 kg/m2 (males) and 20-30 kg/m2 (females).

Exclusion Criteria:

* Males: history, current or suspected prostate or breast cancer.
* Female: pregnant or lactating.
Non-contrast Enhanced MRI in Patients With C3 Glomerulopathy (C3G) or Immune-complex Membranoproliferative Glomerulonephritis (IC-MPGN) Enrolled in the ACH471-205 Study

Functional and quantitative renal magnetic resonance imaging (MRI) has seen a number of recent advances, and techniques are now available that can generate quantitative imaging biomarkers with the potential to improve the management of kidney disease.

However, there are knowledge gaps that must be addressed before renal MRI methods could be more widely adopted in clinical research and ultimately be transferred to clinical practice, including the biological basis of different MRI biomarkers, and how the application of these biomarkers will improve patient care.

Among renal MRI techniques, renal diffusion weighted MRI (DWI) has been increasingly used in the last decade, showing high potential as a surrogate and monitoring biomarker for interstitial fibrosis in chronic kidney disease (CKD), as well as a surrogate biomarker for the inflammation in acute kidney diseases that may impact patient selection for renal biopsy in acute graft rejection.

Within the ready-to-start ACH471-205 clinical trial, an Open-Label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) treated with ACH-0144471, aimed at evaluating the efficacy of 12 months of oral ACH-0144471 in patients with C3G or IC-MPGN, patients will undergo baseline and 12-month follow-up renal biopsies, and renal function will be assessed over time by estimated or measured (when available) glomerular filtration rate (GFR). Adding multi-parametric NCE-MRI to the examinations under the ACH471-205 study protocol will give the opportunity to elucidate, in a well-defined cohort of patients, the potential of NCE-MRI as biomarker of renal microstructure and functional change.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of C3G or IC-MPGN;
* Patients enrolled in the ACH471-205 study at the Bergamo center;
* No contraindications to perform MRI.

Exclusion Criteria:

- Ferro-magnetic prosthesis, aneurysm clips, severe claustrophobia or other contraindications or exclusions interfering with the MRI assessment.
The Efficacy of Extra- Versus Intrafascial Injection for Supraclavicular Brachial Plexus Block

Patients will be randomized to one of two groups:

1. Extrafascial injection group: Ultrasound-guided supraclavicular brachial plexus block with 2 injections of local anaesthetic, deposited at the exterior of the fascial sheath that surrounds the nerves
2. Intrafascial injection group: Ultrasound-guided supraclavicular brachial plexus block with 2 injections of local anaesthetic, deposited at the interior of the fascial sheath that surrounds the nerves

The study will be proposed to all patients undergoing formarm or hand surgery under axillary brachial plexus block. Patients will be randomized to one of two groups.

The first group - extrafascial injection group - will receive an ultrasound-guided supraclavicular brachial plexus block whereby the local anesthetic will be deposited at the exterior of the fascial sheath that surrounds the nerves.

The second group - intrafascial injection group - will receive an ultrasound-guided supraclavicular brachial plexus block whereby the local anesthetic will be deposited at the interior of the fascial sheath that surrounds the nerves.

All patients will receive the same type and amount of local anesthetic: 30 ml of a mixture of ropivacaine 0.5 % + mepivacaine 1 %.

The primary outcome is the rate of hemidiaphragmatic paresis 30 minutes after the block procedure, assessed with ultrasound. Secondary outcomes are: rate of hemidiaphragmatic paresis 2 hours after surgery, assessed with ultrasound, bedside spirometry before the supraclavicular block, 30 minutes after the block and 2 hours after surgery, rate of successful block 30 minutes after the block , duration of sensory and motor block, pain scores at rest and on movement at 24 h postoperatively, cumulative postoperative opioid consumption at 24 hours postoperatively and patient satisfaction with overall anesthetic management.

These outcomes are further defined in the section below.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing forearm or hand surgery under locoregional anesthesia
* ASA physical status I-III

Exclusion Criteria:

* Patient refusal
* ASA physical status IV
* Severe pre-existing lung disease
* Patient unwilling or unable to perform incentive spirometry
* Local anesthetic intolerance or allergy
* Neurological deficit or neuropathy of the arm
* Coagulopathy contraindicating locoregional anesthesia
* Malignancy or infection in the area above the clavicle
* Pregnancy
* Inability to understand the informed consent
Safety and Pharmacokinetics of an Extract of Naringenin

This study evaluates the safety of administering single ascending doses (150, 300, 600, and 900 mg) of a citrus extract of the flavonoid narigenin, and assesses the blood concentrations of naringenin following oral administration of the extract.

Naringenin is a component of food with therapeutic potential to improve glucose metabolism. In order to explore the mechanisms by which naringenin may increase energy expenditure and improve glucose metabolism in humans, it is of vital importance that the safety, tolerability, and bioavailability of naringenin are evaluated, when administered to humans. This study tests the safety of four doses of a citrus extract of naringenin and measures serum concentrations of naringenin at the 150 mg and 600 mg doses over a period of 24 hours, and at the 300 and 900 mg doses at four hours after subjects have been given the respective doses of naringenin.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years)
* Body mass index between 20 and 35 kg/m2
* Must have fasting blood sugar \<126 mg/dL)
* Must be willing to refrain from consuming citrus fruits and tomato in any form, for 36 hours prior to each test day.

Exclusion Criteria:

* Report citrus allergies.
* Report a history of cardiovascular disease, diabetes, or cancer
* Have evidence of hepatic disease or dysfunction
* Are currently pregnant or breastfeeding
* Are women of childbearing potential who will not use an effective method of birth control
* Chronically use of medications except over the counter medications that have been stopped 72 hours prior to the study visit
* Report clinically significant GI malabsorption syndromes
* Have clinically significant abnormal laboratory markers
* Anticipate surgery during the study period.
* Report history of substance abuse or alcoholism or significant psychiatric disorder that would interfere with the ability to complete the study.
* Have donated blood during the month prior to study entry or plan to do so during the study.
* Have participated in other studies using an investigational drug during the preceding three months.
* Are current smokers or have smoked within the previous three months.
Single Center Experience Over a Decade in Living Donor Liver Transplantation for Egyptian Patients With Hepatocellular Carcinoma: Stretching the Limits

Within community with high incidence of HCC, stretching the limits could be justified based on tumor characters and its biological behavior

590 Egyptian patients underwent LDLT; of them, 172 (32%) patients were transplanted for HCC. Twenty six cases (15.1%) were excluded due to early postoperative mortality (n=22) or due to non HCC related mortality (n=4). One hundred forty six patients were retrospectively reviewed to determine prognostic factors for recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Egyptien Patients with HCC
* Patients within Milan Criteria
* Patients beyond Milan criteria are selected on a case by case basis until 2005. From 2005 , patients beyond Milan criteria are subjected to down staging protocol and then reassessed (pre transplantation local ablative therapy either with RFA or TACE according to the size and the site of the lesion and we wait for 12 weeks after ablation ,only those with well ablated lesions, decreased AFP and no denovo lesions were transplanted).

Exclusion Criteria:

* • Evidence of macro vascular invasion by CT portography and/or US duplex.

  * Metastatic HCC
  * General contraindications for LT (ongoing sepsis, other major co morbidities,...).
  * Early postoperative mortality (first1 month).
  * Post transplant mortality during the period of follow up due to any cause other than recurrent HCC (e.g. sepsis, rejection, cardiological or cerebrovascular complications...)