cyrilzakka/clinical-trials huggingface dataset:
Insulin Resistance in Multiple System Atrophy

Multiple system atrophy (MSA) is a rare and fatal neurodegenerative disorder. The pathologic hallmark is the accumulation of aggregated alpha-synuclein in oligodendrocytes forming glial cytoplasmic inclusions. Some symptomatic treatments are available while disease-modification remains an unmet treatment need. Post-mortem findings suggest insulin resistance, i.e. reduced insulin signaling, in the brains of MSA patients. The aim of this study is to complete the target validation of insulin resistance for future treatment trials.

Multiple system atrophy (MSA) patients have a poor prognosis with a median survival ranging between 6 and 10 years. MSA belongs to the synucleinopathies, which are characterized by the abnormal accumulation of alpha-synuclein. We have recently shown brain insulin resistance (i.e. reduced insulin signaling) in post-mortem brain tissue of MSA patients and transgenic MSA mice, as illustrated by increased protein levels of insulin receptor substrate-1 phosphorylated at serine 312 (IRS-1pS312). Additionally, exendin-4, an approved anti-diabetic drug targeting glucagon-like peptide-1 (GLP-1) receptors, was capable of decreasing brain levels of IRS-1pS312 and preserving dopamine neurons in transgenic MSA mice. We further observed an inverse correlation between plasma neural-derived exosomal IRS-1pS312 levels and survival of dopamine neurons in transgenic MSA mice.

The aim of this study is to further characterize peripheral and central insulin resistance in MSA patients, thereby validating this target for future treatment trials. For this purpose, fasting blood glucose and insulin levels will be determined in samples of MSA patients and healthy controls for a homeostatic model assessment of insulin resistance (HOMA). Additionally, IRS-1pS312 will be measured in neural-derived plasma exosomes of MSA patients and healthy controls.

Eligibility Criteria:
Inclusion Criteria:

Patients :

* Patients suffering from "possible" or "probable" MSA according to clinical consensus criteria (Gilman et al., 2008).
* Age \> 30
* Written informed consent
* Patient covered by the national health system

Controls:

* Patients not suffering from a neurologic disorder
* Age \> 30
* Written informed consent
* Patient covered by the national health system

Exclusion Criteria:

For patients and controls:

* Presence of a diabetes
* Treatment with corticosteroids, estrogen, atypical antipsychotics, and anti-retroviral agents
* Patient under tutelage
* Patient unable to give consent
* Any other neurologic disorder
* Pregnancy and breastfeeding
* MOCA ≤21
* Contraindication to perform an MRI
Study of DCR-PHXC-101 in Normal Healthy Volunteers and Patients With Primary Hyperoxaluria

This is a double-blind, placebo-controlled, dose escalation trial of DCR-PHXC in Healthy Volunteers (HVs) and patients with Primary Hyperoxaluria (PH). Once safety has been established in HV, PH patients with a confirmed diagnosis of PH1 and PH2 will be enrolled across multiple dosing cohorts. The study design will allow enrollment of PH patient cohorts at a given dose level once safety has been demonstrated in HV at that dose level. The study will be conducted in two parts: Part A: Single ascending dose (SAD) in HV; Part B: SAD in patients with PH1 and PH2 (lagging Part A by 1 dose level cohort).


Eligibility Criteria:
Group A (HVs) Major Inclusion Criteria:

* Willing and able to provide informed consent and comply with study requirements.
* Male or female subjects between 18 and 55 years of age, inclusive.
* Subject must have a body mass index (BMI) 19.0 to 32 kg/m2, inclusive.
* Non-smokers, at least 1-month tobacco free, and willing to remain tobacco free through end of study (EOS).
* Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception.

Group A (HVs) Major Exclusion Criteria:

* Presence of any medical condition, including but not limited to: Severe intercurrent illness, known causes of active liver disease.
* Routine or chronic use of more than 3 grams of acetaminophen (Tylenol) daily.
* History of kidney stones.
* Use of any investigational agent within 90 days before the first dose of study medication.
* History of donation of more than 450 mL of blood within 90 days prior to dosing in the clinical research center or planned donation less than 30 days after receiving Investigational Medicinal Product (IMP).
* Plasma or platelet donation within 7 days of dosing and through EOS.
* History of reactions to an oligonucleotide-based therapy.
* Males with female partners who are planning to attempt to become pregnant during this study or within 90 days after last dosing of IMP.
* Plasma or platelet donation within 7 days of dosing and through EOS.

Group B (PH1 and PH2 patients) Major Inclusion Criteria:

* Willing and able to provide informed consent and comply with study requirements.
* Male or female, at least 6 years of age.
* Minimum body weight of 25 kg.
* Genetic confirmation of PH1 and PH2 disease.
* Meet the 24 hour urine oxalate excretion requirements.
* Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2.
* If taking Vitamin B6 (pyridoxine), must have been on stable regimen for at least 4 weeks.

Group B (PH1 and PH2 patients) Major Exclusion Criteria:

* Prior renal and/or hepatic transplantation.
* Currently receiving dialysis.
* Participation in any clinical study where they received an investigational agent within 4 months before enrollment.
* Presence of any medical condition, including but not limited to: Severe intercurrent illness, known causes of active liver disease.
* Liver function test (LFT) abnormalities.
* History of reactions to an oligonucleotide-based therapy.
Evaluation of Educational Interventions Targeting Beliefs About Human Papillomavirus (HPV)

The goal of this clinical trial is to compare the effects of two different educational training programs on beliefs about Human Papillomavirus (HPV) in a group of female hospital employees. The main questions it aims to answer are: • Within the scope of the study, are the training programs provided to reduce misconceptions about HPV effective? • Which educational program is more effective in reducing misconceptions about HPV? Participants will • Complete a pre-test online the day before the first training date to determine the level of their misconceptions about HPV. • Receive informative messages via Whatsapp once a day for three days according to the training program they are assigned to. • Repeat the pre-test at the end of the training programs and one month later. • Receive the more effective training program after one month after the test repetition for the control group. Researchers will compare "Misbeliefs about HPV" and "Current Knowledge about HPV" titled training programs on reducing misconceptions about HPV.

The human papillomavirus (HPV) can cause health problems ranging from warts in the mouth or genital area to cervical, vaginal, vulvar, penile and anal cancers. Some beliefs about diseases or infectious agents have a negative impact on the early diagnosis and treatment of diseases, particularly by increasing the stigmatization effect of sexually transmitted diseases. Features such as the fact that mucosal contact is sufficient for transmission, that infected people can be symptom-free for a long time, that cancer often develops slowly, and that there are similarities with other sexually transmitted viruses such as HIV (human immunodeficiency virus) or herpes can have a negative impact on knowledge and beliefs about HPV.

It is known that it is crucial to emphasize correct information, not to repeat or point out inaccuracies when taking action to combat false beliefs or myths. In the context of the COVID-19 pandemic, the importance of this approach has been frequently emphasized in the guidance contained in the confirmatory information on misinformation and disinformation. In our study, we want to compare the effectiveness of education models in which false beliefs or myths about HPV are conveyed before or after the current information.

Eligibility Criteria:
Inclusion Criteria:

* Woman
* Age \>18 years and older
* Those who agree to participate in the study

Exclusion Criteria:

* Age \<18 years
* Those who not agree to participate in the study
Risk and Resilience Factors in Learning Disabilities Population

The purpose of this study is to report preliminary outcomes of executive function and psychopathology symptoms of a manual-based psychological intervention for adolescents diagnosed with learning disorders- I can succeed (ICS).


Eligibility Criteria:
Inclusion Criteria:

* Learning Disorder diagnosis
* Normal range IQ
* Regular class attendance

Exclusion Criteria:

* Suicidal ideation and psychosis
Study to Assess Oropharyngeal Carriage of N. Meningitidis in South Australian School Leavers

This is an observational cross sectional study to evaluate the impact of a 4CMenB vaccination program on oropharyngeal N. meningitidis carriage in vaccinated and unvaccinated school leavers.

This carriage study of a cohort of school leavers in South Australia (SA) will provide an opportunity to assess carriage rates in the young adult population (school leavers) following introduction of a 4CMenB vaccination program in senior school students from 2017-2018.This will allow a comparison of carriage prevalence in the two years (2018 and 2019) following implementation of the school program to assess impact on carriage at a population level and compare carriage prevalence in vaccinated versus non-vaccinated groups. Assessment of any association between risk factors and prevalence of nasopharyngeal carriage in school leavers will be made and compared between vaccinated and unvaccinated students.

School leavers are defined as students who were enrolled in year 12 at school in the preceding year of recruitment and have been chosen as they are likely to have the highest carriage rates. A high proportion (approximately two thirds) of students will be immunised by the time of throat swab collection in years 2018 and 2019. Assessing carriage in both vaccinated and unvaccinated cohorts will further inform the effect of 4CMenB vaccine on carriage at a population level. This will help determine any herd immunity impact of 4CMenB vaccine and persistence of any effect.

Eligibility Criteria:
Inclusion Criteria:

* South Australian school leavers between 17 to 25 years of age (enrolled in year 12 in the previous year ie year 2018, students are eligible if they were enrolled in year 12 in 2017, year 2019, students are eligible if they were enrolled in year 12 in 2018).

Exclusion Criteria:

* No exclusion criteria
Simple Preparation of Endotracheal Tube

To observe the effect of additional E-tube angulation on intubation time and success rate.

The hypothesis of this study is that shaping endotracheal tube by end-to-end connection before induction will provide more optimal angulation for endotracheal intubation.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled for elective surgery requiring general anesthesia and tracheal intubation

Exclusion Criteria:

* Patients with congenital or acquired upper airway lesions
* Patients with high risk of aspiration
Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center

The purpose of this study is to determine if a single dose of sublingual sufentanil given 15-30 minutes prior to wake up is efficacious at reducing recovery room time.

This is a level I randomized prospective outcomes study comparing two groups of patients. Within 15-30 minutes of planned wake-up Group 1 will receive 30 mcg of sublingual sufentanil and group 2 will not receive sublingual sufentanil.

Eligibility Criteria:
Inclusion Criteria:

- Adult patients undergoing outpatient ambulatory surgery undergoing general anesthesia for orthopedic surgery

Exclusion Criteria:

* non-english speaking patients
* patients who have allergy or intolerance to the study drugs or derivatives
Canthaxanthin Retinopathy: A Long-term Observation

Canthaxanthine is a naturally occurring carotenoid that has been a popular over-the-counter oral artificial tanning agent in Europe, Canada, and Australia since 1979. It is also used at low dosage as a food-colouring agent and as a therapeutic agent for photosensitivity disorders such as erythropoietic protoporphyria. Canthaxanthin retinopathy was first described in 1982 by Cortin et al. In Germany the office of the federal board of health refused the permit for oral tanning agents containing canthaxanthine in 1985. At that time the long-term course of the disease was not known. 25 years later the investigators did these long-term follow-up examinations.


Eligibility Criteria:
Inclusion Criteria:

* patients using oral tanning agents for at least 2 months.
* patients of 18 years or older

Exclusion Criteria:

* none.
Atherosclerotic Coronary Vulnerable Plaque: Correlation With Coronary Artery Calcium

The aim of this study is to compare the relationship between the coronary artery calcification assessed by MDCT with the plaque characteristics and necrotic lipid core content of non-intervened coronary segments assessed with near infrared spectroscopy (NIRS) in patients with symptomatic coronary artery disease (CAD).

A total of 60 patients, from a single center, who meet all of the study inclusion criteria and none of the study exclusion criteria will be prospectively enrolled in this study. Qualifying patients will be referred to the study site for clinically indicated, non-emergent cardiac catheterization with NIRS evaluation, either proceeded or followed by coronary artery calcium score (CACS) evaluation.

Qualifying patients that are referred directly to cardiac catheterization with NIRS assessment secondary to symptoms or abnormal functional test will be sent for cardiac CACS assessment following the catheterization before discharge from the hospital. In this group, patients who require ad hoc PCI upon initial angiography will be excluded to avoid artifacts on CACS. In patients who are referred for a clinically indicated cardiac catheterization with IVUS evaluation within 3 months after MDCT with CACS, NIRS of at least two (2) major epicardial vessels will be completed prior to any (if necessary) coronary revascularization.

Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥18 years of age
* Patient is clinically indicated due to angina, abnormal functional test or other ischemic symptoms to undergo non-emergent cardiac catheterization with IVUS evaluation i.If the patient has not had a cardiac MDCT with CACS meeting the protocol requirements within 3 months prior to the cardiac catheterization, the patient is able to undergo CACS following LipiScan IVUS and NIRS evaluation, prior to any coronary revascularization ii. If the patient has had a cardiac MDCT evaluation with CACS meeting the protocol requirements within 3 months prior to the cardiac catheterization, LipiScan IVUS and NIRS imaging will be completed in at least two (2) major epicardial vessels prior to any coronary revascularization
* At least two (2) major epicardial native vessels are suitable for interrogation by LipiScan IVUS imaging and NIRS evaluation, defined as:

  i.At least 30 mm of vessel that is \> 2.0mm in diameter ii.No other contraindications to imaging
* No contraindications for LipiScan IVUS and NIRS evaluation
* No contraindications for CACS evaluation by MDCT
* Subject must be able to provide informed consent form and comply with the protocol requirements

Exclusion Criteria:

* Evidence of clinical hemodynamic instability in the 6 hours before either procedure
* Prior history of percutaneous coronary intervention (PCI) with stent placement
* Prior history of bypass grafts
* Female subject that is pregnant or lactating
* Any other factor that the investigator feels would put the patient at increased risk or otherwise make the patient unsuitable for participation in the protocol
The Undernourished Patient: Prevention and Treatment

The purpose of this study is to determine whether a nutrition intervention during a rehabilitation stay followed by nutritional advice after discharge, can improve the nutritional status of the patients after 3 months.


Eligibility Criteria:
Inclusion Criteria:

1. In risk of undernutrition or undernourished according to the screening tool NRS-2002, score 3 or above.
2. Living in Oslo, Bærum or Asker municipality.
3. Must be able to cooperate.

Exclusion Criteria:

1. Unwilling to participate
2. Less than 12 months life expectancy
IPT of Malaria With SP in Different Zones of Drug Resistance in Rwanda

The present study will address the question whether the use of IPT using SP in pregnancy is efficacious in Rwanda, where it is going to be used for the first time, in areas with high levels of SP resistance. While the implementation of the new policy will take place in areas at low SP resistance level, where we expect pregnant women and newborns to benefit from it, it is of paramount importance to clarify which is the real impact of IPT/SPin areas of high SP drug resistance and at what level of SP resistance this strategy is still efficacious. As bed nets are a part of the actual control strategy of malaria in pregnancy all women will receive a bed net at enrolment

The present study will address the question whether the use of IPT using SP in pregnancy is efficacious in Rwanda, where it is going to be used for the first time, in areas with high levels of SP resistance. While the implementation of the new policy will take place in areas at low SP resistance level, where we expect pregnant women and newborns to benefit from it, it is of paramount importance to clarify which is the real impact of IPT/SPin areas of high SP drug resistance and at what level of SP resistance this strategy is still efficacious. As bed nets are a part of the actual control strategy of malaria in pregnancy all women will receive a bed net at enrolment.

This will be a randomized blinded placebo controlled trial: women in the 16-28th week of gestation will be offered enrolment into the study and randomized to receive IPT/SP regimen or placebo once during the second and once in the third trimesters.

The study will be conducted in Mashesha (estimated SP drug resistance 20%, 12% in 2000), Kicukiro (40% SP resistance) and Rukara (60% SP resistance). In each of these sites there are about 1000 deliveries per year. According to DHMT data, over 75% of pregnant women attend antenatal clinics, usually booking between 15 and 25 weeks of gestation. Based on this study we expect to find placental malaria prevalence over 50% in all sites.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women between 16-28 weeks of gestation;
2. Residence within the catchment's area of the health facility;
3. Willing to deliver at the health facility;
4. Willing to ; adhere to all requirements of the study;
5. Willing to provide written informed consent;
6. Aged 21 years and above

Exclusion Criteria:

1. Severe anemia (Hb \< 6 g/dL)
2. History of allergic reactions to sulfa drugs;
3. Taking other sulfa drugs as CTX;
4. History of known pregnancy complications (e.g. breech presentation, severe pre-eclampsia, prior caesarian section);
5. History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis, prior to randomization;
6. Any significant illness that requires hospitalization;
7. Intent to move out of the study catchment's area before delivery or deliver at relative's home out of the catchment's area;
8. Prior enrollment in the study or concurrent enrollment in another study
Awareness of Osteoporosis in Multiple Sclerosis Patients

Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Multiple sclerosis patients are at increased risk for developing osteoporosis. Identifying whether multiple sclerosis patients have information and awareness about this disease is crucial. This study is aimed to investigate awareness and knowledge of osteoporosis in multiple sclerosis (MS) patients. The study also aimed to assess potential differences and correlations in osteoporosis knowledge and awareness among MS patients based on gender, education levels, and risk of falls

Osteoporosis is a common disease of bone loss. The reduced bone strength predisposes an increased risk for fractures in older individuals. It can affect people from different ethnicity. Many factors increase the risk of osteoporosis, including age, postmenopausal state, glucocorticoid use, low body weight, calcium, vitamin D, immobility, and chronic inflammation. Patients with multiple sclerosis are at high risk of developing osteoporosis due to chronic inflammation and their medications. Patients' knowledge and awareness about osteoporosis are essential for early detection, implementation of lifestyle changes, and treatment compliance. This study aimed to investigate osteoporosis awareness and knowledge about osteoporosis in patients with multiple sclerosis.The study also aimed to assess potential differences and correlations in osteoporosis knowledge and awareness among MS patients based on gender, education levels, and risk of falls

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of multiple sclerosis
* Must be between the ages of 18 and 99
* Must give consent to participate in the study

Exclusion Criteria:

• Not giving consent
Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular Pressure

To determine the predictive factors of a positive response to latanoprost 0.005% / timolol 0.5% fixed combination (defined as a 10% IOP reduction from baseline), after 12 weeks of treatment (age, sex, ethnic origin, patient's medical history, family history of OAG or OHT, concomitant systemic treatment with beta-blockers, etiology, IOP at baseline, corneal thickness, compliance, and adverse events).


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients,
* Aged \> than equal to 18 years,
* Patient presenting with an OHT or OAG with an IOP � 21 mmHg,
* Patient currently treated with ophthalmic beta-blockers monotherapy and requiring a change of the ophthalmic medication due to insufficient response to treatment,

Exclusion Criteria:

* Patient currently treated by or having received within the last month any ophthalmic hypotensive agent other than a beta-blocker,
* Patient presenting any contraindication to latanoprost or timolol,
* Patient with history of asthma, obstructive broncho-pneumopathy, sinusal bradycardia (pulse rate \< 60 bpm), auriculo-ventricular block, cardiac insufficiency, Raynaud disease or any other condition that would preclude the patient from taking the prescribed medication,
* Patient with known intolerance to benzalkonium chloride or any excipient contained in the trial treatment,