cyrilzakka/clinical-trials huggingface dataset:
CHP677: I-Metaiodobenzylguanidine (I-MIBG) Therapy for Refractory Neuroblastoma: a Phase II Study

131I-metaiodobenzylguanidine (131I-MIBG) is a norepinephrine analog that concentrates in adrenergic tissue and therefore holds promise for cell-specific treatment of neuroblastoma. This is a dual institution, Phase II study of 131I-MIBG administered at the previously defined maximum practical dose of 18 mCi/kg to children with relapsed or refractory neuroblastoma.


Eligibility Criteria:
Inclusion criteria: Refractory neuroblastoma with original diagnosis based on tumor histopathology or elevated urine VMA with typical tumor cells in the bone marrow.
Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects

The purpose of this study is to compare pharmacokinetics between Pitavastatin and Valsartan co-administration and Livalo fixed combination drug in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers
* Age 20-55 years at the time of Screening
* BMI 19-26 kg/m2 at the time of Screening

Exclusion Criteria:

* Received other investigational drug within 90 days prior to the first dose of study drug
Bioequivalence Study for Gemigliptin/Metformin 50/1000 mg and Coadministration of Gemigliptin 50 mg and Metformin 1000 mg.

\[Objectives\]Primary: To determine and compare the rate and extent of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg FDC tablet (Zemimet® SR Tab. 50/1000 mg) and coadministration of corresponding dose of gemigliptin 50 mg (Zemiglo Tablet 50 mg) and metformin hydrochloride 1000 mg prolonged release (Glucophage XR 1000 mg) as individual tablet in healthy subjects under fasting conditions Secondary: To evaluate safety of test and reference formulations


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18.0 to 30.0 kg/m2.
* Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening.
* Non-pregnant woman (negative pregnancy test) and not currently breast feeding
* Female subjects abstain from either hormonal methods of contraception
* Male subjects who are willing or able to use effective contraceptive
* Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.

Exclusion Criteria:

* History serious hypersensitivity reactions
* History or evidence of clinically significant diseases or any significant ongoing chronic medical illness
* History or evidence of family diabetes
* History or evidence of type 1 diabetes mellitus, diabetic ketoacidosis, diabetic pre-coma
* History or evidence of shock or severe dehydrate or severe infection
* History or evidence of preceding diarrhea or vomiting within 24 hours prior to admission in each period
* History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse
* History of problems with swallowing tablet or capsule
* History of sensitivity to heparin or heparin-induced thrombocytopenia
* Any condition possibly affecting drug absorption
* Have renal creatinine clearance (Clcr) \< 45 mL/min based on serum creatinine results at the screening laboratory test
* 12-lead ECG demonstrating QTc \>450 msec, a QRS interval \>120 msec or with an abnormality considered clinically significant at screening
Preliminary Study of Feasibility of Arthrodesis Scapula-humeral Under Arthroscopy

Arthrodesis shoulder blade/humerus under arthroscopy. Implementation of an external fixative spray at the proximal level in the thorn of the scapula and distal in the diaphysis humerus.

This trial is about the arthrodesis shoulder blade/humerus under arthroscopy. The main aim of this study is to be able to carry out a fusion scapula-humeral supplements in 6 months. It is required to provide the benefice risk over to reduce the hospitalisation 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* Patient having a deficit scapula-humeral mobility
* Impossibility of being operated for a preserving nervous surgery
* Patient affiliation with a social security
* Patient who signed inform consent

Exclusion Criteria:

* Patient with No mobility in all the articulations of the shoulder
* Callus malunion of the higher end of the humerus or the glen of the scapula
* Unable to sign an inform consent
Efficacy and Safety Stress Urinary Incontinence Study

Study F1J-MC-SBBT will examine the effect of duloxetine treatment in women with SUI. The inclusion and exclusion criteria of this Phase 3 study will ensure that all subjects have a clinical diagnosis of SUI.


Eligibility Criteria:
Inclusion Criteria:

* Are greater than 20 years of age.
* Are female outpatients.
* Present with SUI based on the disease diagnostic criteria, average at least one incontinent episode per day on the screening diary, and have had symptoms of SUI for a minimum of 3 months prior to study entry.
* Are women of non-childbearing potential by reason of hysterectomy, other surgery, or natural menopause, or are women of childbearing potential who test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a medically accepted means of contraception (for example, intrauterine device \[IUD\], oral or injectable contraceptives, implant, barrier device, sterilization, abstinence, or sex with a vasectomized male partner) for the duration of the study. Women using oral contraceptives or hormone replacement therapy must have a stable dose and regimen for greater than or equal to 3 months prior to entry into the study.
* Have no language barrier, agree to comply with the requirements of the protocol, and sign a written informed consent document prior to entry into the study.

Exclusion Criteria:

* Suffer from severe constipation (for example, have impacted rectum at time of physical examination despite recent evacuation).
* Has a physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject.
* Are on a medication regimen (including diuretics) for which dose and/or frequency has not been stable for at least 12 weeks prior to randomization, or is anticipated to change during the course of the study.
* Have had any major inpatient surgery within 3 months prior to study entry.
* Have current diagnosis of any of the following conditions, disorders, or diseases of the genito-urinary tract: Ureteric, bladder, urethral, or rectal fistula
* Uncorrected congenital abnormality leading to urinary incontinence
* Detrusor instability or noncompliant bladder
* Adult enuresis
* Voiding difficulty (i.e., subject complains of difficulty emptying their bladder).
Study of the Location of Motor Cortical Stimulation Electrodes in Chronic Neuropathic Refractory Patients

Cortical stimulation has been used since 1991 to treat neuropathic pain. However, the underlying mechanisms are still incompletely understood and under-studied. In this protocol, the investigators aim to study the myeloarchitectonic and functional characteristics of areas activated by cortical epidural electrodes and to determine their relation to therapy response in chronic neuropathic refractory pain patients.


Eligibility Criteria:
Inclusion Criteria

* adults
* patient implanted with a motor cortical stimulation system for chronic neuropathic refractory pain,
* patient with available postoperative scanner

Exclusion Criteria: None
Reverse Or Nothing For Complex Proximal Humeral Fractures

Reverse shoulder prosthesis has recently emerged as an acute treatment for complex proximal humeral fractures. Promising functional results have been reported in observational papers.

However, no clinical trials have yet been reported when comparing the conservative treatment to surgical treatment through the use of reverse shoulder arthroplasty.

Introduction The proximal humeral fractures are frequent in the investigator's environment. Among them, about 20% are considered as complex features. Conservative treatment has traditionally offered an extensive range of results. The reverse shoulder prosthesis as a treatment for acute fractures of the proximal humeral in the elderly population has changed the therapeutic approach of this acute pathology. However, high-level evidence-based studies are still not available, when comparing the conservative treatment with the treatment with reverse shoulder prosthesis.

Objective To compare the functional results and complications of elderly patients presenting acute complex fractures of the proximal humerus through two types of treatments; conservative treatment and treatment with reverse shoulder prosthesis.

Methodology A prospective, multicentre and randomized study comparing conservative treatment with the surgical treatment at two years followup by the use of functional shoulder assessment (Constant scale), complications and re-interventions associated with each treatment. The quality of life will also be analyzed through the SF-36 health questionnaire

Expected results The null hypothesis of the work is based on the appearance of non-significant differences between the two groups of the study (conservative vs. surgical treatment), concerning functional status, complications, and re-interventions

Eligibility Criteria:
Inclusion Criteria:

* Patients with mental conditions available for rehabilitation protocols
* Patients presenting a 3 or 4 part proximal humeral fracture

Exclusion Criteria:

* Extremely displaced fractures with no bony contact or less than 1 cm.
* Cognitive impairment (Pfeiffer test \>3)
* Shoulder dislocations
* Unable to sign informed consent or unable to respond to questionnaires
* Trauma or previous surgery of the extremity
* Open or pathological fracture
* Vascular or neurological injury associated
* Unable to collaborate with rehabilitation
* Patients with serious comorbidities that discourage surgery
Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients

Primary Objectives:

Part A (dose ranging study):

To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks.

Part B (pivotal study):

To demonstrate that sarilumab added to MTX was effective in:

* reduction of signs and symptoms of rheumatoid arthritis at 24 weeks
* inhibition of progression of structural damage at 52 weeks
* improvement in physical function at 16 weeks

Secondary Objectives:

Part B:

To demonstrate that sarilumab added to MTX was effective in induction of a major clinical response at 52 weeks

To assess the safety of sarilumab added to MTX

To document the pharmacokinetic profile of sarilumab added to MTX in participants with active rheumatoid arthritis who were inadequate responders to MTX therapy.

The total study duration for a participant was 16-22 weeks (Part A) and 56-62 weeks (Part B) broken down as follows:

* Screening: Up to 4 weeks
* Treatment: 12 weeks (Part A) and 52 weeks (Part B)\*
* Follow-up: 6 weeks (for participants who would not continue in the long-term extension study).

'\*' Participants successfully completing their treatment period would be offered the opportunity to enter the long term extension study LTS11210 (SARIL-RA-EXTEND) (NCT01146652).

Eligibility Criteria:
Inclusion criteria :

* Diagnosis of rheumatoid arthritis ≥3 months duration
* Active disease defined as:

  * at least 8/68 tender joints and 6/66 swollen joints,
  * high sensitivity C-reactive protein (hs-CRP) \>6 mg/l,
  * continuous treatment with MTX for at least 12 weeks prior to baseline visit and on stable dose for at least 6 weeks prior to screening visit.

Part B only:

* Bone erosion based on documented X-ray prior to first study drug intake, or
* Cyclic Citrullinated Peptide (CCP) positive, or
* Rheumatoid Factor (RF) positive.

Exclusion criteria:

* Age \<18 years or \>75 years.
* Treatment with disease-modifying antirheumatic drugs (DMARDs) other than MTX within 4 weeks or 12 weeks prior to screening (depending on DMARDs).
* Past history of non-response to prior Tumor Necrosis Factor (TNF) or biologic treatment.
* Any past or current biologic agents for the treatment of rheumatoid arthritis within 3 months.
* Use of parenteral glucocorticoids or intraarticular glucocorticoids within 4 weeks prior to screening visit.
* Use of oral glucocorticoid greater than 10mg/day or equivalent/day, or a change in dosage within 4 weeks prior to baseline visit.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Thai Traditional Massage Increases Biochemical Marker of Bone Formation in Postmenopausal Women

To investigate the skeletal effect of Thai traditional massage by examining the changes in biochemical markers of bone turnover.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women

EXclusion Criteria:

* History of hyperthyroidism, thyrotoxicosis, diabetes, rheumatoid arthritis and cancer
* glucocorticoid or medication for osteoporosis
* Swelling joints
Continuous Versus Conventional Volume Management During CRRT (Continuous Renal Replacement Therapy)

Use of on-line blood volume monitoring during continuous renal replacement therapy can improve volume management in acute kidney injury patients requiring renal replacement


Eligibility Criteria:
Inclusion Criteria:

* Patients with kidney injury requiring continuous renal replacement therapy and volume removal

Exclusion Criteria:

* unable to provide or obtain patient consent
* not expected to survive 48 hours
Emergency Delirium in Pediatrics Undergoing Tonsillectomy and Adenoidectomy

Primary outcom Compare the effectiveness of study drugs on reducing the incidence of emergence delirium .

Secondary outcomes:

Sedation score Intensity of pain by FLACC Extubation time Iength of stay in Post anesthetic care unite (PACU ) Incidence of negative post operative behavioural changes (NPOBCs ) Laryngeospasm ny adverse effects

Emergence delirium (ED) is a common neurologic complication that can not only distress children and their families in the early postanesthetic period, but can also have adverse effects on children in the long-term Emergence delirium (ED) is an acute confusion state during recovery from anesthesia; patients with ED may present with disorientation, hallucination, restlessness, and purposeless hyperactive physical behavior . ED is not fully equivalent to EA; ED can involve hypoactive signs or mixed forms and hyperactive signs similar to agitation . Nevertheless, the terms EA and ED have been used interchangeably in several studies Pediatric patients undergoing tonsillectomy and adenoidectomy usually have a high incidence of POED, which increases the risk of developing postoperative airway obstruction and respiratory depression due to anatomical characteristics of operative location and increased susceptibility to opioid analgesics.

Postoperative emergence delirium develops in 12% to 18% of all children undergoing general anesthesia for surgery.

dexmedetomidine, is a selective alpha-2 agonist, which works in the brain and spinal cord that has sedative, analgesic and anxiolytic properties. Dexmedetomidine also has the ability to lower the overall anesthetic requirements by reducing sympathetic outflow in response to painful surgical stimulation.

Midazolam is a widely used intravenous anesthetic agent with rapid onset, short duration of action and relatively rapid plasma clearance. It is mainly used to produce preoperative sedation and the induction of general anesthesia The action of midazolam can be explained through its action on gammaaminobutyric acid (GABA) receptors. GABA receptors mediate inhibitory neurotransmission in the central nervous system In our study we aim to compares the effectiveness of preoperative intravenous dexmedetomidine versus intravenous midazolam for the prevention of emergence delirium in pediatric patients undergoing tonsillectomy , adenoidectomy or both . .

Eligibility Criteria:
Inclusion Criteria:

- Pediatric patients aged 2-12 years

With ASA physical status 1 or 2

Who were scheduled for tonsillectomy with and without adenoidectomy under general anesthesia

Exclusion Criteria:

* Emergency surgery

Intellectual disability

Neurological disease

Renal , hepatic, cardiac or respiratory disease

Allergy to the study drugs
A Clinical Investigation of the Copeland™ Humeral Resurfacing Head

The purpose of this study is to perform a five-year, prospective evaluation of the Copeland™ Humeral Resurfacing Head Prosthesis for outcome and durability. Relief of pain and restoration of function will determine long-term clinical outcome while durability will be measured by the absence of revisions.


Eligibility Criteria:
Inclusion Criteria:

* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
* Rheumatoid arthritis
* Correction of functional deformity
* Reconstructable Rotator Cuff
* Treatment of acute fracture of the humeral head
* Traumatic arthritis

Exclusion Criteria:

* Patients less than 18 years.
* Patients with rapid joint destruction, osteomalacia, osteoporosis, or marked bone loss, which would preclude proper fixation of the prosthesis.
* Patients with marked bone loss apparent on roentgenogram.
* Metabolic disorders, which may impair bone formation.
* Patients who are pregnant.
* Patients with an active or suspected infection in or around the shoulder or distant foci of infections, which may spread to the implant site.
* Patients with severe instability or deformity of the ligaments and/or surrounding soft tissue, which would prelude stability of the prosthesis.
* Patients who have had revision procedures where other devices or treatments have failed.
* Patients with a highly communicable disease or diseases that may limit follow-up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis, neoplastic disease, etc).
* Patients unwilling or unable to comply with a rehabilitation program for a cemented or cementless partial or total shoulder replacement or who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.
* Patients with previous shoulder surgery or conditions that may interfere with the partial or total shoulder replacement's survival or outcome.
* Patients who qualify for inclusion in the study, but refuse consent to participate in the study.
* Patients who have had a partial or total shoulder arthroplasty on the contralateral shoulder within the last year.
Do Therapy Dogs Improve Behavior and Reduce Anxiety in Pediatric Dental Patients?

The goal of this clinical trial is to assess whether the presence of a certified therapy dog during dental procedures that require an injection reduces anxiety and improves behavior in pediatric dental patients.

The main questions it aims to answer are:

* Does the presence of a certified therapy dog during dental procedure requiring an injection reduce anxiety and improve behavior in pediatric dental patients?
* How do the parents of pediatric dental patients who participate in the study view the use of a certified therapy dog in their child's treatment?
* Does the presence of a certified therapy dog result in different concentrations of microbes in the treatment room?

All participants will receive standard of care. Researchers will compare the group with a therapy dog present to a group who does not have a therapy dog present to see if heart rate, oxygen saturation, percentage of nitrous oxide administered, and Frankl scores differ between the groups.


Eligibility Criteria:
Inclusion Criteria:

* Age 3-7
* Children who are patients at the Medical University of South Carolina Department of Pediatric Dentistry
* Children classified as category 1 or 2 according to the American Society of Anesthesiologists Physical Status Classification
* Children whose parents/guardians are willing to consent to the child participating in the study
* Availability of parent to be present during treatment
* Children who require further care that includes the injection of a local anesthetic and whose procedure will take less than one hour

Exclusion Criteria:

* Patients whose cases are considered emergencies
* Patients who are classified as category 3 or higher according to the American Society of Anesthesiologists Physical Status Classification (6)
* If patient's medical status has worsened since initial evaluation
* Known allergy to dogs or other animals
* Past history of dental trauma
* Past history of animal bites or traumatic experience with a dog
* Emotional or developmental delays
* If, on the day of the treatment, patient presents with fever or other illness
Efficacy of Variable Lidocaine Concentrations in Tumescent Anesthesia for Pain Control During and After Endovenous Laser Procedure; Non-inferiority Trial

Endovenous laser treatment is a minimally invasive procedure that has been shown to be a safe and effective treatment for varicose veins. Essential to the successful ablation of refluxing veins by endovenous laser treatment is the use of tumescent anesthesia. One of the components of tumescent anesthesia is lidocaine, a commonly used local anesthetic. While lidocaine can be used safely as long as serum concentrations remain low, its use carries the risk of lidocaine toxicity. In order to minimize the risk of lidocaine toxicity it is desirable to use the minimum effective concentration of lidocaine needed to manage pain during a procedure. This study seeks to determine if a ¼ lower concentration of lidocaine in tumescent anesthesia will function as well as the standard dose for pain management in endovenous laser treatments. If we find that this is the case, we will be able to reduce the risk of lidocaine toxicity in patients undergoing endovenous laser treatment, while maintaining their comfort throughout the procedure. This will be achieved through a direct comparison of intra- and post-operative pain for patients randomized to receive either the ¼ tumescent lidocaine concentration or the standard lidocaine concentration.


Eligibility Criteria:
Inclusion Criteria:

* Large Saphenous Vein treatment
* 16-85 years old, good health
* Able to understand informed consent
* Eligible for EVLT determined by physician

Exclusion Criteria:

* Patients with know lidocaine sensitivity
* Bleeding disorders
* Pregnancy
* Congestive heart failure
* Liver dysfunction
* Patient ineligible for EVLT
COVID-19: Herd Immunity Study in the Czech Republic

The aim of the SARS-CoV-2-CZ-Preval study is to quantify the prevalence of individuals with a history of SARS-CoV-2 coronavirus infection in the Czech population, except for those diagnosed with COVID-19 by methods based on direct detection of SARS-CoV- 2, including individuals with a subclinical course of the disease.

COVID-19 is caused by a new type of coronavirus called SARS-CoV-2. It is a highly infectious disease, manifested mainly by fever, respiratory problems, muscle pain, and fatigue. However, despite the publication of hundreds of papers in the literature, fundamental information about the spread and course of the disease is still lacking in COVID-19. One of such key pieces of information is the prevalence of asymptomatic individuals with SARS-CoV-2 infection, which has a significant effect on the dynamics of the spread of COVID-19 in the Czech Republic and within individual regions and localities.

The SARS-CoV-2-CZ-Preval study is aiming at quantification of the prevalence of individuals with a history of SARS-CoV-2 coronavirus infection in the Czech population, except for those diagnosed with COVID-19 by methods based on direct detection of SARS-CoV- 2, including individuals with a subclinical course of the disease.

Eligibility Criteria:
Inclusion Criteria:

* signed Informed Consent
* residing in The Czech Republic
* demographic criteria: (i) persons aged 8-17 (specific children's cohort), (ii) persons aged 18-89
* clinical criteria: (i) without acute health problems (ii) without a confirmed diagnosis of COVID-19
* geographic criteria: according to a particular cohort definition