cyrilzakka/clinical-trials huggingface dataset:
A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism

The objective of the trial is to evaluate the efficacy and safety of dasiglucagon administered as a subcutaneous (SC) infusion in reducing hypoglycemia in children with CHI.


Eligibility Criteria:
Inclusion Criteria:

* Established and documented diagnosis of CHI based on standard of care
* Experiencing ≥3 events of hypoglycemia per week (plasma glucose \[PG\] \<70 mg/dL \[\<3.9 mmol/L\]) according to the investigator's evaluation
* Previously undergone near-total pancreatectomy or being treated with a non-surgical approach, having been evaluated as not eligible for pancreatic surgery
* If somatostatin analogues or sirolimus are used, the therapy should be well established as judged by the investigator, especially when considering their biological half-life

Exclusion Criteria:

* Previous administration of dasiglucagon
* Known or suspected allergy to the trial drug or related products
* Previous participation (randomization) in this trial
* Circulatory instability requiring supportive medication or presence of pheochromocytoma
* Requires exogenous insulin
* Body weight of \<4 kg (8.8 lbs.)
* Documented HbA1c ≥7% subsequent to near-total pancreatectomy and within 6 months prior to screening
* Known or suspected presence of significant central nervous system disease/injury such that in the investigator's opinion will affect trial participation
* Use of systemic corticosteroids, e.g., hydrocortisone \>20 mg/m2 body surface area or equivalent in the 5 days before screening
* Use of anti-inflammatory biological agents, or other immune modulating agents in the 3 months prior to screening
* Any clinically significant abnormality identified on echocardiogram that in the opinion of the investigator would affect the patient's ability to participate in the trial
* Any recognized clotting or bleeding disorders
* Has participated in an interventional clinical trial (investigational or marketed product) within 3 months of screening or 5 half-lives of the drug under investigation (whichever comes first), or plans to participate in another clinical trial.
Approaches for Open Reduction and Internal Fixation of Mandibular Condylar Fracture

The condylar region is the most frequent anatomical site for mandibular fractures .

Condylar fractures constitute 25.5% to 35.5% of all mandibular fractures. The mandibular condyle fracture is a type of fracture that affects the condyle, which is the knuckle-like projection of the mandible (lower jaw) that articulates with the temporal bone to form the temporomandibular joint (TMJ).

Several approaches have been used for condylar fracture including intraoral, preauricular, submandibular and retromandibular approaches.

The selection of the appropriate surgical approach for condylar neck fracture represents a controversy.

The purpose of this Study is to Compare the outcomes and effectiveness between the retromandibular transparotid approach and retromandibular retroparotid approach for treatment of Condylar Fracture of Mandible.

Eligibility Criteria:
Inclusion Criteria:

* ALL Patients diagnosed with Extra Capsular Fracture of Mandibular Condyle amenable for surgery.

Exclusion Criteria:

* 1. Open Laceration in the condylar region. 2. Concomitant traumatic Facial Nerve injury. 3. Previous Surgery in Retromandibular region. 4. Severe Obese patients 5. Patients Refusing Surgery.
Intervention in the Management of Post-high Tuberculosis Hospital Through Educational Strategy and Oversight Distance

Brazil ranks 17th among the 22 countries responsible for 80% of tuberculosis (TB) cases in the world. In 2010, the number of new cases of tuberculosis in Brazil was 71,930 and in 4972 RS. In 2010, Brazil had a disease incidence of 37.6 / 100,000 in 2011 fell to 36.0 / 100,000. The Rio Grande do Sul(RS)S showed an incidence rate of 46.1 / 100,000 in 2011. The mortality rate was 2.4 / 100,000 population per year in Brazil and RS.

In Porto Alegre, the incidence rate of all clinical forms of tuberculosis has remained, in the last six years, around 100/100.000 inhabitants per year, while the coefficient of pulmonary tuberculosis remained on average 50/100.000 inhabitants to year. Thus, Porto Alegre holds the 2nd place in Brazil among the capitals with the highest incidence of TB, classifying the city as high risk 5th. Porto Alegre also has a co-infection TB / HIV from 35.3% one of the highest in the country.

The best strategy to prevent new cases of tuberculosis is to invest in early diagnosis and effective treatment of existing cases of the disease. As the treatment of the disease requires daily use of medications for an extended period of time (at least 6 months), adherence becomes the main determinant of the rate of healing of disease.

There are several factors that contribute to poor adherence and treatment dropout: alcoholism, illicit drug use, infection with human immunodeficiency virus (HIV Human Immunodeficiency Virus), low education, unemployment, poor housing and prolonged the treatment. The irregular treatment and neglect are the major obstacles to the control and elimination of this disease.

Study in Porto Alegre pointed alcoholism, TB / HIV, the fact that the patient does not reside with family and low education as predictors of dropout. The dropout rate in the general population of patients with active tuberculosis was 10.7% (8.0% - 17.0%). Abandonment occurred more often within the first three meses8.

In Porto Alegre, 32.5% of new TB cases are diagnosed in hospitals. Twenty percent of these patients do not bind, after discharge, the Tuberculosis Control Program (TCP), ie, the patient egress from the hospital does not reach the basic health unit (BHU) reference for further monitoring and treatment, which is considered a serious flaw in the process control of the disease.

Primary objective Test the impact on the tuberculosis cure rate of an intervention based on education and supervision from a distance in the post-discharge management of new cases diagnosed in hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be aged over 18 years.
* Diagnosis in hospital

Exclusion Criteria:

* cases where there is change in diagnosis after onset of treatment
* cases reintroduction of treatment after default
* relapse cases
Association of TNFAIP3 With Immune-mediated TTP

This study aims to investigate whether genetic variation in the TNFAIP3 locus is associated with immune-mediated thrombotic thrombocytopenic purpura (iTTP), and whether such association is mediated by decreased expression of A20 (TNFAIP3). The study includes a case-control design to assess genotype-expression association and a cohort study to evaluate clinical outcomes such as disease relapse.


Eligibility Criteria:
Patients:

Inclusion Criteria:

* Diagnosis of iTTP
* Above 12 years of age
* Caucasian, Italian origin
* Written informed consent to participate in the study

Exclusion Criteria:

* Patients who do not meet the above-listed criteria will be excluded from participation in the study.

Controls will be healthy Italian volunteers of Caucasian ethnicity, with no history of thrombotic thrombocytopenic purpura, frequency-matched to cases by age and sex, and who have provided written informed consent to participate in the study.
Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment

Background: Pasireotide treatment is strictly associated with glucose metabolism impairment. The aim of the study was to evaluate the effect of pasireotide on β -cell and adipose function in patients with Cushing's disease (CD).

Methods: Clinical and hormonal parameters, insulin secretion, evaluated by homostasis model assessment (HOMA-β) and by the area under the curve (AUC2h) of C-peptide during a mixed meal tolerance test and insulin sensitivity, evaluated by the euglycemic hyperinsulinemic clamp, were evaluated in 12 patients with active CD before and after 12 months of pasireotide.

Circulating adipokines were evaluated in patients with CD compared to a matched group of 12 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* patients with active Cushing's disease.

Exclusion Criteria:

* pituitary radiotherapy treatment performed less than 5 years before pasireotide,
* pregnancy,
* women taking oral contraceptives,
* diabetes on GLP-1 analogues,
* DPP4 inhibitors or sulphonylureas treatment,
* intolerance to SSA,
* risk conditions for prolonged QT syndrome and severe liver o renal insufficiency.
Substance P as a Biomarker to Evaluate the Reduction of Multiple Immunization Pain

Immunization is one of the most significant preventive health measures in reducing morbidity and mortality caused by infectious diseases. Studies have shown that Sucrose is recommended to reduce pain associated with vaccination in neonates. The main aim of the study was to determine the effectiveness of sucrose in reducing infant's pain outcomes during immunization among 10-24 month-old infants and toddlers.


Eligibility Criteria:
Inclusion Criteria:

* All healthy children who were attending immunization clinic to have their 10-24 month immunization were invited to this study

Exclusion Criteria:

* Exclusion criteria included children: whose parents choose to breastfeed during immunization, who have received an analgesia in the previous 24 hours including Paracetamol (so as not to affect the response to painful stimuli during immunization), who cannot receive their immunization due to the presence of immunization risk factors as determined by the immunization nurse, who are not able to receive a sugar solution, and whose parents refuse to participate.
Mesenchymal Stem Cells Treatment for AIDS Patients at Late Stage

The goal of this study is to conduct a prospective, double-blind, randomized placebo-controlled clinical trial to investigate the safety and efficacy of mesenchymal stem cells treatment for AIDS patients at late stage.

Mesenchymal stem cells (MSCs) possess immunomodulatory, anti-inflammatory, and regenerative properties. The safety and effectiveness of MSCs have been investigated in various clinical trials for the treatment of several disorders, including graft-versushost disease, inflammatory bowel disease, and multiple sclerosis. It has been reported that MSC treatment in HIV-infected patients with immunological nonresponders resulted in a significant increase in circulating CD4+ T lymphocytes and a decrease of the activation of T lymphocytes and soluble inflammation mediator levels without significant adverse effects or loss of viremia control. However, the therapeutic efficacy of MSC treatment for AIDS patients at late stage is not well-understood. This study aims to investigate the safety and efficacy of MSC treatment for AIDS patients at late stage.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed HIV infection, aged 18-65, both genders
2. CD4+T count less than 350 cells/ul at baseline.
3. No serious AIDS related events. 3. could understand and sign the informed consent form and comply with the requirements of this study.

4. agree not to participate in other studies and not to receive other immunotherapies during the period of participation in this study

Exclusion Criteria:

1. have HBV/HCV/HDV/HEV infection, and the virological test is positive.
2. The viral load for CMV and EBV is more than 1000 copies/ML.
3. have HIV-2 infection.
4. have serious complications in organs including renal, circulatory, respiratory, digestive, endocrine, neural and immunological diseases and tumors.
5. received treatment of hormones or other immunosuppressive drugs for a long time.
6. with serious AIDS related or unrelated events.
7. received immunosuppressive drugs or systemic cytotoxic drugs for more than 3 months before recruiting
8. have poor compliance during treatment.
9. drug addiction within 6 months, or the urine drug test is positive
10. participate in other clinical trials currently
11. pregnant, breastfeeding, or have fertility requirements.
12. unable or unwilling to provide informed consents, or unable to comply with research requirements.
13. Other serious situations that may hinder clinical trials.
Laparoscopic Hysterectomy - Outpatient Versus Inpatient Regimen

Laparoscopic Hysterectomy (LH) is increasingly used as a standard surgical approach to hysterectomy. It is a safe procedure with low rates of complications and readmissions. Increasing evidence indicates that LH may be suitable for an outpatient setting but this may impair patient's satisfaction in more than 25% of cases. In addition, change from in-patient care to day case surgery might influence readmission rates and postoperative physical activity. No data are available on the current length of sick leave in Danish patients after hysterectomy, and the effects of outpatient surgery on this parameter are difficult to predict. A randomized controlled trial of LH performed as an outpatient procedure compared with today's inpatient standard will provide a firm platform for future planning of routine treatment of patients with need of hysterectomy for benign indications.

Hysterectomy is the most frequent gynecological operation world wide and the indication is often benign. The women are healthy and young with a median age below 50 years. In Denmark, hysterectomy is performed as an inpatient procedure with a median hospitalization of 1 day. Hysterectomies in Denmark are distributed by 45% abdominal hysterectomies (AH), 35% vaginal hysterectomies (VH) and 20% laparoscopic hysterectomies (LH). There is no final consensus whether VH or LH should be recommended as first choice but LH is gaining more and more acceptance. Increasing evidence indicates that LH may be suitable for an outpatient setting. Data seem to assure that outpatient LH is feasible but patient's satisfaction in this setting remains an open question. A detailed analysis of data from a Norwegian study indicates that patients reporting dissatisfaction with the early discharge amounts to 25-38%. Such a decrease in patient's satisfaction would present a significant problem, and a randomized controlled study of sufficient size with focus on this aspect is therefore needed.

Recommendations on postoperative sick leave vary considerably, due to lack of evidence-based guidelines and no firm data are available on the relation between outpatient treatment and sick leave in gynecology.

This randomized controlled study attempt to examine outpatient LH and patient satisfaction and related subject as readmissions and complications, time to return to work, physical activity in the recuperation period and an overall socioeconomic calculation of the costs of LH in an in- and outpatient setting.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women below 56 years who is in need of a hysterectomy for benign conditions.
* Additional surgery is allowed in the gynecological area.
* BMI and working status is NOT exclusion criteria's.

Exclusion Criteria:

* Unable to read and write Danish to answer questionnaires.
* Unable to walk to carry a pedometer.
Emerging Invasive Fungal Infections in Critically Ill Patients

Rationale: Beside Candida and Aspergillus, emerging invasive fungal infections (EIFIs) are increasing in intensive care setting and are associated with high morbidity and mortality. However, data are scarce, particularly in ICU settings and for EIFIs other than mucormycosis.

Objectives: to describe epidemiological trends and clinical features of EIFIs in intensive care units (ICU) and to assess their outcome.

Methods: All records of adult patients diagnosed with an EIFI in a medical ICU between 2006 and 2019 were analyzed retrospectively. In-ICU mortality was assessed, then factors associated with mortality were identified. Survival at day-90 was calculated by the Kaplan-Meier method.


Eligibility Criteria:
Inclusion criteria:

- Adults (≥ 18 years old) with at least 1 positive culture for molds other than candida and aspergillosis

Exclusion criteria:

- Age \< 18, pregnancy
Effect of Cognitive Behavioural Therapy (CBT) for Children With Autistic Spectrum Disorders

Cognitive Behavioural Therapy is an effective intervention program for children with High-Functioning Autistic Spectrum Disorder to remediate anxiety issues.


Eligibility Criteria:
Inclusion Criteria:

* Assessed to have Autistic Spectrum Disorder, Asperger Syndrome, Pervasive Developmental Disorder, Not Otherwise Specified by the DSM-IV criteria, based on clinical interview, Asperger Syndrome Diagnostic Scale (ASDS) or Autism Diagnostic Observation Schedule (ADOS)
* Child have a Verbal Comprehension Index of 80 and Perceptual Reasoning Index of 90 and above
* No change of medication dosage 1 month prior to the commencement of program for the child and through out the duration of the study
* Written parental consent and assent from children above 12 years old

Exclusion Criteria:

* Children with Verbal Comprehension Index of 80 and Perceptual Reasoning Index of 90 and below.
* Children who are undergoing other Cognitive Behavioural treatment program concurrently
* Those without parental consent will not be able to participate
Immunogenicity and Safety of Concomitant Administration of Bivalent COVID-19 Vaccines With Influenza Vaccines

The goal is to evaluate the immunogenicity and safety of coadministration of a bivalent BA.4/BA.5-adapted COVID-19 booster vaccine, and influenza vaccine among healthy adults during 2022-23 season.

This was an open-label, non-randomized clinical trial conducted at the International St. Mary's Hospital in Incheon, South Korea. This study included two study groups: Concomitant administration of bivalent BA.4/BA.5 mRNA COVID-19 booster and quadrivalent influenza vaccination (QIV) and separate administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later

* immunogenicity analysis : Blood was drawn at baseline and follow-up visit 4 weeks (day 28±7) after immunization.
* safety analysis : At 7 days after each vaccine dose, the participants were requested to record the occurrence, severity of solicited adverse events (AEs) through a standardized electronic questionnaire. Participants were also asked to record any unsolicited AEs during the 28 days after vaccination.

Eligibility Criteria:
Inclusion Criteria:

* who agreed to receive both bivalent booster COVID-19 vaccine and influenza vaccine
* Only individuals who had passed at least 3 months after the last confirmation of SARS-CoV-2 infection and/or the third dose of COVID-19 vaccination

Exclusion Criteria:

* Individuals with a contraindication to any of the vaccine compounds were excluded from the study
Robotic Assisted Cochlear Implantation Feasibility Study

A first in man clinical trial to asses the the use of am image guided robotic system to safely and effectively create a minimally invasive access tunnel to the middle ear cavity to allow access to the round window for cochlear implant electrode insertion.

A first in man feasibility study of an image guided robotic system for performing a key-hole approach to the middle ear cavity.

Eligibility Criteria:
Inclusion Criteria:

* Geographically and physically able to attend scheduled evaluations and follow-up appointments
* Indicated for cochlear implantation
* Age 18 years or older
* Fluent in German or French
* Sufficient facial recess size ( \> 2.5 mm between the facial nerve and chorda tympani)

Exclusion Criteria:

* Pregnancy
* Anatomical malformation of the middle or inner ear or unusual facial nerve course
* Lack of compliance with any inclusion criteria
Clinical Study to Evaluate Tear Characteristics Following Acute TrueTear™ Use

This study will evaluate the change in tear meniscus height (TMH) produced by intranasal stimulation with TrueTear™ compared with the same device applied extranasally (control).


Eligibility Criteria:
Inclusion Criteria:

* Baseline Ocular Surface Disease Index© (OSDI©) score of at least 23 with no more than three responses of "not applicable"
* In at least one eye, a baseline Schirmer test of ≤ 10 mm/5 minutes AND a cotton swab nasal stimulation Schirmer test of at least 7 mm higher in the same eye

Exclusion Criteria:

* Chronic or recurrent epistaxis, coagulation disorders or other conditions that may increase the risk of bleeding
* History of nasal or sinus surgery
* Vascularized polyp, deviated septum or severe nasal airway obstruction at the Screening visit
* Intraocular and extraocular surgery in either eye within three months of the Screening Visit or refractive surgery within twelve months of the Screening Visit
* Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head
Acute Effects of Static Stretching on the Shoulder Joint Position Sense of Overhead Athletes

The purpose of the study is to investigate the acute effects of static stretching on the shoulder joint position sense of overhead athletes.

A crossover randomized controlled trial will be conducted with 17 overhead athletes (9 males and 8 females). All of them will perform the 3 study conditions in random order: a control (5-minute rest), and static stretching of 30 or 90 seconds of muscles around the shoulder. The shoulder joint position sense will be assessed before and immediately after these conditions, and tested by active repositioning for the range of 110º of flexion, with a video camera. Absolute, relative and variable angular errors will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged between 18 and 30 years
* Competitive overhead athletes (basketball, handball, volleyball, swimming)
* Normal range of motion of flexion of the shoulder

Exclusion Criteria:

* History of injury of the shoulder joint in the previous 6 months
* Positive shoulder joint integrity tests (anterior drawer; fulcrum test; Jerk test; and sulcus sign)
A Study to Compare the Effectiveness of Adductor Canal Pain Catheters Following Total Knee Arthroplasty

The purpose of this research is to study how well the adductor canal pain catheters works after a total knee arthroplasty or replacement of the knee joint. The catheter works by using either an intermittent bolus injection to provide a large dose of medication or continuous infusion of pain medicine, ropivacaine 0.2%, compared to a single-shot adductor canal block.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 90 years.
* Willing to participate in the study and competent to provide informed consent.
* Willing to comply with protocol procedures.
* Has an underlying diagnosis of osteoarthritis indicated for a total knee arthroplasty.

Exclusion Criteria:

* The patient must not have taken any narcotic medications (schedule II) during the 3 months leading up to the surgery.
* The patient must not be allergic or intolerant to a medication used in the multimodal pain pathway.
* Revision knee arthroplasty.
* Uncontrolled diabetes with A1C \> 8.0%.