cyrilzakka/clinical-trials huggingface dataset:
Patients 60 Years and Older Suffering From Mandibular Fractures Registry

Approximately 200 of patients of 60 years or older who present a mandibular fracture will be enrolled in this registry. All patients will be treated and followed up according to the local standard (routine) of care at around 2 weeks, 6 weeks, 3 months and 6 months after treatment.

Patients of 60 years or older who present a mandibular fracture will be enrolled in this registry. All patients will be treated (surgical or non-surgical) and followed up according to the local standard (routine) of care at around 2 weeks, 6 weeks, 3 months and 6 months after treatment.

Data collection will include patient and fracture details, treatment details, functional, clinical and patient-reported outcomes and anticipated or procedure- and implant-related adverse events (i.e. complications). Radiographs and/or other images (e.g. CT scan) taken as per standard of care will be collected within the registry.

Primary objectives are to obtain epidemiological data and describe the most common mandibular fracture patterns in older patients, to explore the relationship(s) between the treatment of mandibular fractures and its outcome in older patients, to identify risk factors and initiating factors of elderly related to mandible fracture events and to describe concomitant fractures associated with mandibular fractures in older patients.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 60 years at the time of the injury
* Diagnosis of any kind of mandibular fracture
* Informed consent obtained, i.e.:

  * Ability to understand the content of the patient information/ informed consent form (ICF)
  * Willingness and ability to participate in the clinical investigation according to the Registry Plan (RP)
  * Signed and dated EC/IRB approved written informed consent OR For patients who are not able to provide independent written informed consent: Written consent provided according to defined and IRB/EC approved procedures

Exclusion Criteria:

* Patients with previous history of mandibular fractures or mandibular defects treated surgically
* Participation in any other medical device or medicinal product study within the previous months that could influence bone healing and the results of the present study in the opinion of the treating physician
WHO Versus IADPSG Diagnostic Criteria of Gestational Diabetes Mellitus and Their Associated Maternal and Neonatal Outcomes

Aim for this study is to measure the prevalence of Gestational Diabetes Mellitus (GDM) using World Health Organisation (WHO) versus International Association of Diabetes in Pregnancy Study Group (IADPSG) criteria among pregnant mother in Universiti Kebangsaan Malaysia Medical Centre (UKMMC)

It will then be used to measure the incidence of adverse maternal and neonatal outcomes in women diagnosed with GDM using either of the criteria.

Patients with risk factors for GDM will be recruited and randomised to either group once fulfilled the inclusion and exclusion criteria and agreed to join this study. Subjects will then undergo 75g oral glucose tolerance test and diagnosis will be established based on the group assigned.

Eligibility Criteria:
Inclusion Criteria:

* Malaysian citizen and able to speak and understand Malay or English
* Pregnant women with one or more risk factors for GDM between 14-37 gestational weeks
* Singleton pregnancy

Exclusion Criteria:

* Inability to complete OGTT
* Women previously diagnosed with Type 2 and Type 1 DM
* Pregnant women who refuse to participate
Diagnosis of Depression Among Adolescents

The objective of the study is to improve general practitioners' diagnoses of adolescent depression. Major depression is ranked fourth in the worldwide disability impact. The proportion of adolescents suffering from depressive disorders also seems to be increasing worldwide. Early interventions are known to reduce this illness. Therefore, the earlier depression can be identified in adolescents, the greater the advantage.


Eligibility Criteria:
Inclusion Criteria:

* age (14-16)

Exclusion Criteria:

* not fluency in the Norwegian and Danish language
Expanded Access to Navitoclax

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to navitoclax prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility Criteria:
Effect of Antenatal Corticosteroids on Neonatal Morbidity.

It will be a randomized controlled trial. There will be two study groups. Study group 1 will be given dexamethasone while study group 2 will be given betamethasone. The control group will be given placebo.

The study will be a double blind randomised controlled trial. There will be two study groups and one control group.

The first study group will be the pregnant women at risk of late preterm birth that will receive antenatal corticosteroids in the form of intramuscular dexamethasone sodium phosphate.

The second study group will be the pregnant women at risk of late preterm birth that will receive antenatal corticosteroids in the form of intramuscular betamethasone sodium phosphate.

The control group will be pregnant women at risk of late preterm birth that will be given intramuscular water for injection.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women at 34 weeks 0 days to 36 weeks 6 days of gestation and a probability of delivery in the late preterm period irrespective of diagnosis who give consent.
* Pregnant women at 34 weeks 0 days to 36 weeks 6 days of gestation scheduled for elective/emergency delivery in the late preterm period irrespective of indication and route of delivery who give consent.

Exclusion Criteria:

* Evidence of Chrioamnionitis.
* Evidence of foetal distress.
* History of use of antenatal corticosteroids in index pregnancy.
* Women who do not give consent.
Study of Free DNA Content of Embryo Culture Medium as a Non-Invasive Tool for Embryo Assessment

Study of Cell Free DNA Content of Human Embryo Culture Medium as a Non-Invasive Tool for Embryo Assessment in intra cytoplasmic sperm injection Treatment Cycles.

The aim of the present study is to determine whether cell free DNA content of the culture medium of the human embryo correlates with the quality and reproductive potential of embryos in ICSI cycles and, thus, to look for a new non invasive tool of assessing embryo quality beside morphological assessment. Determining a rapid, noninvasive method for the assessment of the developmental potential of embryos may be a great achievement

Eligibility Criteria:
Inclusion Criteria:

* third day embryos

Exclusion Criteria:

* less than third day embryos
Clinical Trial of Efepoetin Alfa in Healthy Subjects

An open-label, parallel-group, single-center, Phase I study to compare the pharmacokinetic/pharmacodynamic characteristics, safety, and tolerability of a single intravenous administration of Efepoetin Alfa in healthy subjects

This study is to objectively evaluate pharmacokinetics as well as pharmacodynamic responses after a single intravenous administration of the Efepoetin alfa, GX-E4, in healthy Caucasian and Asian volunteers.

Eligibility Criteria:
Key Inclusion Criteria:

1. Adult males and females between the ages of 19-45
2. Asian or Caucasian
3. Body weight \>50 kg and \<90 kg, BMI 18 \~30 (BMI(kg/m2) = Weight(kg) / {Height(m)}2)
4. Normal hemoglobin range.
5. Normal Serum ferritin and transferrin saturation range.
6. Normal serum folate range
7. Normal vitamin B12 range
8. White blood cell \>=3.0 X 10\^3 /mm3
9. Platelet \>= 150 X 10\^3/mm\^3 and \<450 X 10\^3/mm\^3
10. Nonsmoker or smoker who smokes below 10 cigarettes a day.

Key Exclusion Criteria:

1. An allergy history, including drug allergies(example: aspirin, antibiotics, etc.) or clinically significant allergy.
2. Liver(including viral hepatitis), renal, respiratory, endocrine, neurological, immunological, blood, psychological, or circulatory system abnormalities, or a history of cancer.
3. Subject who had received EPO, darbepoetin, other EPO supply protein, or immunoglobulin administration, or had received intravenous iron administration.
4. Hypersensitivity to EPO and/or to the excipients of the IMP, or known hypersensitivity to supplementary iron products.
5. Hemoglobinopathy (homozygous sickle cell disease, all types of thalassemia)
6. Systolic blood pressure below 90mmHg or above 140mmHg, or diastolic blood pressure below 50mmHg or above 90mmHg after taking a rest over 3 minutes; pulse rate over 100bpm
7. C-reactive protein level \>4mg/dL at 2 weeks prior to the IMP administration.
8. A drug abuse history, or positive in a urine drug-screening test(cocaine, amphetamines, barbiturates, opiates, benzodiazepine, and cannabinoids)
9. Signs of fever, with a temperature of over 38°C, within 1 week before particiation
10. History of epileptic seizure within 6 months before participation
11. Positive to HIV antibody, HBsAg, and HCV antibody test.
12. Consumes over 21 units of alcohol per week, or a person who cannot stay sober for the duration of the entire trial period.
13. Blood donation or a bleeding episode of more than 400mL within 8 weeks prior to study participation
14. The maximum length of the spleen \>16cm.
15. Person thought inappropriate by the investigator in consideration of the laboratory test results.
16. Pregnant or breast-feeding.
The Effect of Applying Multidisciplinary Bundle Intervention on the Delirium Incidence in Critically Ill Patients

The patients will exposed to different intervention through three nights (ear plug, eye mask). 50 patients in the age range 18- 60 years admitted to ICU of Assiut university hospitals will be randomly allocated into into two groups (control group and intervention group).

The multicomponent bundle of interventions is designed to be multidisciplinary, and included measures taken to reduce noise, light and iatrogenic sleep disturbance, as well as attempts to modify risk factors for delirium. The patients will exposed to different intervention through three nights (ear plug, eye mask) grouping of nursing activity to be delivered before the 23:00 or delay their completion until after 08:00 where possible. Orientate patients regarding time, place and date every eight hours.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old.
* No hearing problems.
* No eye disease.

Exclusion Criteria:

* Head injury.
* Psychiatric disease.
* Shocked patients
Effects of Hepatic Ultrasound on Metabolic Homeostasis

The purpose of this study is to define the effect of ultrasound exposure of the liver in the region of the porta hepatis on glucose homeostasis and insulin resistance in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 60 years of age
* Aim 1: Healthy lean men and women, BMI\<24 kg/m2, with normal fasting glucose (blood glucose between 60 and 100mg/dl and normal glucose tolerance on OGTT (blood glucose \<140 mg/dl at 2 hours post glucose challenge) at the screening visit.
* Aim 2: Overweight and obese men and women, BMI 25 - 35 kg/m2

Exclusion Criteria:

* Type 1 and type 2 diabetes
* Surgery in the past 90 days
* Previous surgery of the spleen or splenectomy, esophagus, lungs, stomach, duodenum, or liver
* Recent traumatic injury, including intra-cerebral hemorrhage and visceral injury
* End stage renal disease and/or uremia
* Active malignancy
* Previous leukemia and/or lymphoma
* Human immunodeficiency virus infection or AIDS
* Rheumatoid arthritis or other immune-mediated diseases (e.g. inflammatory bowel disease)
* Arrhythmias, including but not limited to, atrial fibrillation, atrial flutter, bradycardia, ventricular arrhythmias, and A-V block
* Implanted pacemaker or cardioverter/defibrillator (AICD)
* History of stable or unstable angina, myocardial infarction, angioplasty or coronary arterial by-pass grafting surgery
* History of stroke or TIA
* History of deep venous thrombosis (DVT) and/or pulmonary embolism (PE)
* Previous episodes of pancreatitis
* Spinal disorders
* Chronic pain syndromes
* History of thrombosis or bleeding disorders
* Stage III-IV pressure ulcers
* Sickle cell anemia or other anemia syndromes
* Monocytosis
* Thrombocytopenia
* Diagnosed with fever of unknown origin (FUO)
* Previously or currently implanted vagus nerve stimulator
* Previously or currently implanted spinal cord stimulator
* Other chronically-implanted electronic medical device
* History of seizures
* History of cancer
* Individuals who have taken any of the following medications within two weeks of receiving ultrasound delivery: anti-coagulant, anti-platelet, anti-inflammatory, immunosuppressive agents, alpha and/or beta adrenoceptor blocking agents, anti-seizure medications, anti-diabetic medication
* Individuals with a substance abuse problem
* Pregnant women
* Ascites detected in the abdomen that may effect delivery of shear wave elastroghapy pulse
Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy

The purpose of this study is to assess long-term safety of avacincaptad pegol intravitreal administration for patients with geographic atrophy (GA) who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham).


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 50 years or greater diagnosed with GA inside and/or outside of the fovea who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment.
* Patient must provide new written informed consent for this OLE trial prior to participation.
* Patient must have the ability to return for all trial visits for the duration of the 18-month trial.

Exclusion Criteria:

* Patient did not complete Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham),
* Patient who had the study drug permanently withdrawn for an AE during ISEE2008 are not eligible.
* Patient did not enroll into this OLE trial within the 90 day enrollment period.
* Patient who is pregnant or nursing
A Study of the Long-term Safety and Efficacy of Adalimumab in Subjects With Intermediate-, Posterior-, or Pan-uveitis

The purpose of this study is to evaluate the long term efficacy and safety of adalimumab participants with non-infectious intermediate-, posterior- or pan-uveitis.

This study was initially planned to run for 78 weeks but was extended for ethical reasons, to avoid leaving participants untreated who had responded well to adalimumab treatment, so that participants were allowed to remain in the study until regulatory and/or reimbursement approval for the treatment of uveitis in adults was obtained for their respective countries. Data were collected through Week 366 (maximum), but because of decreasing sample size that became too small toward the end of the study to allow for meaningful conclusion, data cut off for efficacy analyses (intent to treat \[ITT\] population) occurred at Week 246, as less than 10% of participants in the ITT set had visits beyond this timepoint.

Eligibility Criteria:
Inclusion Criteria:

* Participant must have successfully enrolled in either study M10-877 or M10-880 and either met the endpoint of "Treatment Failure" or completed the study

Exclusion Criteria:

* A participant will be excluded from this study if the participant discontinued from study M10-877 or M10-880 for any reasons other than having a Treatment Failure event
* Participant with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial
* Participants with intraocular pressure of \>= 25 mmHg and on \>= 2 glaucoma medications or evidence of glaucomatous optic nerve injury
* Participant with proliferative or severe non-proliferative diabetic retinopathy or clinically significant macular edema due to diabetic retinopathy
* Participant with neovascular/wet age-related macular degeneration
* Participant with abnormality of vitreo-retinal interface (i.e., vitreomacular traction, epiretinal membranes, etc.) with the potential for macular structural damage independent of the inflammatory process
* Participant with a systemic inflammatory disease that requires therapy with a prohibited immunosuppressive agent at the time of study entry
GRoningen Early-PD Ambroxol Treatment

The most common genetic risk factor for Parkinson's Disease is a heterozygous mutation of the GBA1 gene, encoding the lysosomal enzyme glucocerebrosidase (GCase). Reduced GCase activity is associated with aggregation of the protein alpha synucleine (aSyn) in the central nervous system, which is related to the pathological cause of PD. Ambroxol is a mucolytic expectorant that appears to facilitate the refolding of the misfolded GBA protein thats acts as a chaperone for GCase.

This randomized placebo-controlled trial aims to investigate the disease-modifying properties of ambroxol in PD patients with a GBA1-mutation. Patients will undergo motor and cognitive tests, as well as imaging and blood tests.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's disease, according to Movement Disorders Society (MDS) criteria (27)
* Disease duration of 10 years or less at time of inclusion
* PD patients carrying a GBA1 mutation
* Able to write written informed consent, understanding study protocol and perform protocol related actions
* Willing and able to self-administer oral ambroxol or placebo medication

Exclusion Criteria:

* The refusal to be informed about an unforeseen clinical finding
* Use of an implanted Deep Brain Stimulation (DBS) system
* Confirmed dysphagia that would preclude self-administration of ambroxol or placebo tablets
* History of known sensitivity to the study medication
* Pregnant or breastfeeding women
* Participants of childbearing potential that would not use adequate birth control, consisting of a negative pregnancy test at the screening visit and use of accepted contraceptive methods defined as highly effective while participating in the study
* MRI incompatible implants in the body
* Any clinically significant or unstable medical or surgical condition that in the opinion of the principal investigator may put the participant at risk when participating in the study or may influence the results of the study or affect the participant's ability to take part in the study, as determined by medical history, physical examinations, electrocardiogram (ECG), or laboratory tests. Such conditions may include:

  1. Impaired renal function (a positive urine dipstick test, and laboratory values below or above: a eGFR \<45 ml/min 1,73M2, Sodium 135-145 mmol/L, Potassium 3.5-5.0 mmol/L, Urea 2.5-7.5mmol/L).
  2. Moderate/severe hepatic impairment (laboratory values below or above: ASAT 0- 80U/L, ALAT0-90 U/L, GGT \> 80 U/L, Alkaline Phosphatase 35-210 U/L).
The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease

It is hypothesized that oral naltrexone will improve inflammation of the bowel by increasing endogenous enkephalin levels in subjects with active Crohn's disease. This is especially important in children who often are suffering from nutritional deprivation which retards their growth.

The key objectives are to:

1. Evaluate the effects of low dose naltrexone in children with Crohn's Disease by using the Pediatric Crohn's Disease Activity Index (PCDAI), plasma inflammatory markers, weight, and pediatric quality of life survey.
2. To determine the safety and toxicity of low dose naltrexone in pediatric subjects with active Crohn's Disease.
3. Assess the potential mechanism by which naltrexone exerts its action by measuring plasma opioid (enkephalin and endorphin levels) and proinflammatory cytokines.

The present proposal is designed as double-blinded placebo controlled study involving 30 children between 6-17 years of age with active Crohn's disease. Children will be treated with either naltrexone or placebo for the first 8 weeks then all subjects will receive active naltrexone drug the last 8 weeks. A one month follow-up appointment will be scheduled 4-weeks after completion of the active drug for safety and to assess Crohn's activity. Low dose naltrexone (LDN) will be dispensed in either capsules at a dose of 4.5 mg for those ages 10 years or older and in liquid form at 0.1 mg/kg for those under age of 10 or less than 45 kg. Half of the subjects in the first 8 weeks will be randomized to placebo which will be either capsules filled with avicel (see section 6.0) or diluent (flavored water) if in liquid form. Children are eligible who are not of child-bearing potential or are using two means of effective birth control, have a Pediatric Crohn's Disease Activity Index (PCDAI) of at least 31 points, and have the confirmed diagnosis of Crohn's disease by either endoscopic or radiographic tests.

Eligibility Criteria:
Inclusion Criteria:

* All subjects must give written informed consent by parent or guardian
* Male or female subjects, \> 6 - 17 years
* Patients must have endoscopic or radiographic confirmed Crohn's Disease.
* Patients must have a Pediatric Crohn's Disease Activity Index (PCDAI) of at least 31.

Exclusion Criteria:

* Adolescent women of childbearing potential and / or sexually active unless surgically sterile or using adequate contraception (either IUD, oral or deport contraceptive, or barrier plus spermicide), and willing and able to continue contraception for 3 months after the completion of the study.
* Adolescent women who are pregnant or breastfeeding
* Subjects with an ostomy or ileocolic anastomosis from surgery as these operations interfere with the PCDAI assessment
* Subjects taking tacrolimus, cyclosporin, mycophenolate, or anti-TNF-α therapy must be discontinued 4 weeks prior to study initiation.
* Patients with abnormal liver function tests
* Prednisone greater than 10 mg or \> 0.2 mg/kg orally
A Single-Center, Exploratory Study to Analyze the Dynamics of Skin Microflora Following Exposure to Surfactants

The purpose of this study is to understand the changes in skin microflora, skin barrier function, and skin biochemical constituents in response to direct contact with model surfactants used in personal care articles. The results from this study will provide insights into the complex interaction between the skin microbiome and the epidermis after exposure to surfactants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Subjects with Fitzpatrick Skin Types I, II or III

Exclusion Criteria:

* Subjects with visible skin disease, tattoos, skin condition, or abnormal skin color