cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of Subcutaneous AZD6912 in Healthy Participants

This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of AZD6912 administered subcutaneously (SC) in healthy participants.

In this First-In-Human (FiH) study, eligible participants will be randomly assigned to 6 cohorts in a 3:1 ratio to receive either a single dose of AZD6912 SC or placebo. The first 2 participants in each cohort will be dosed as a sentinel pair, with one receiving AZD6912 SC and the other receiving placebo.

The study will comprise of, a screening period of 70 days, a treatment period where participants will stay at the Clinical Unit from the day before study intervention administration until at least 240 hours and will be discharged on Day 11. Outpatient visits would start weekly from Day 15, then bi-weekly from Day 43, 4-weekly from Day 99, and 6-weekly from Day 155, with additional follow-up visits approximately every 4 weeks as needed until complement activity returns to the normal range.

The study will last approximately 25 months, including the optional Japanese cohorts, with each participant participating for about 38 weeks or longer until complement activity returns to normal range (per local laboratory).

Eligibility Criteria:
Inclusion Criteria:

* Females must have a negative pregnancy test.
* Contraceptive use by males and females should be consistent with local regulations.
* Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg.
* For optional Japanese participants only:

  * Participants must be of Japanese descent defined as: first generation (born to 2 Japanese parents and 4 Japanese grandparents).
  * Born in Japan, and not have lived outside Japan for more than 5 years.
  * Lifestyle, including diet, must not have significantly changed since leaving Japan.

Exclusion Criteria:

* History of any clinically important disease or disorder.
* Current or recurrent disease of clinical significance that could affect clinical assessments or clinical laboratory evaluations.
* Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study intervention.
* History of congenital or acquired immunodeficiency or complement deficiency or an underlying condition that predisposes to infection.
* History of any Neisseria infection, unexplained, recurrent infections, or infection requiring treatment with systemic antibiotics.
* Evidence of hepatitis B infection (positive for HBsAg or positive for anti-HBcAb) or hepatitis C viral infection (HCV Abs or hepatitis C RNA positive) or HIV infection (positive for HIV type 1 or type 2 Abs).
* Participants testing positive for COVID-19 prior to dosing.
* Any cardiac abnormalities.
* A CAP activity \< 60% at screening.
* Known or suspected history of drug abuse, history of alcohol abuse or smoking.
Interest of the Patient Management by Improved Recovery After Surgery in Percutaneous Vertebroplasty

This research aims to demonstrate the benefits of the RAAC program for patients undergoing cementoplasty, in particular on their level of anxiety and pain control throughout the perioperative phase.

The aim of the study is to compare the preoperative anxiety of patients hospitalized for a percutaneous vertebroplasty, depending on whether or not they are managed in an RAAC program.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 80 years or ≥ 18 years with oncological history;
* Patient with vertebral compression fracture with indication for percutaneous vertebroplasty;
* Patient seen in preoperative anesthesia / radiology consultation more than 4 days before the date of the vertebroplasty;
* Having expressed their consent to participate in the study.

Exclusion Criteria:

* Patient with a contraindication to percutaneous vertebroplasty, such as coagulation disorders, or an allergy or hypersensitivity to any of the products administered during the procedure;
* Patient not affiliated to a social security scheme;
* Patient participating in another clinical trial during the follow-up period;
* Inability to understand information related to the study (linguistic, psychiatric, cognitive reason, etc.).
Desmoteplase in Acute Ischemic Stroke (DIAS)

The DIAS study (Part 2) was performed to support the dose finding of desmoteplase treatment in subjects with acute ischemic stroke selected by perfusion/diffusion mismatch on MRI within a time window of 3 to 9 h after stroke-symptom onset. In addition, it assessed safety and tolerability of 3 doses of desmoteplase compared with placebo with special consideration of intracranial hemorrhage and major systemic bleedings.

Acute stroke is the third leading cause of mortality in developed countries and the major medical cause of disability. The outcome can be improved by early treatment with thrombolysis. Alteplase (r-tPA) is the only approved thrombolytic drug in the indication of acute ischemic stroke. However, the use of alteplase is currently restricted by the need to administer it within 3 hours of symptom onset. As the risk of transforming a cerebral infarct into haemorrhage probably rises as the time elapsed increases, a thrombolytic drug that carries a lower risk of haemorrhage than alteplase may offer a wider time-to-treatment window and improve the safety profile.Desmoteplase (DSPA) with its high fibrin specificity, lack of neurotoxicity, potential neuroprotective effect, non-activation by ß-amyloid, and long terminal half-life may account for an improved safety and efficacy profile within the first 9 hours after onset of symptoms.

Eligibility Criteria:
Inclusion Criteria:

* scoring 4 to 20 on the National Institute of Health Stroke Scale (NIHSS)
* showing a perfusion-diffusion mismatch on MRI of 20 %
* enrolment within a 3 h to 9 h time window after symptom onset.
* 18-85 years of age

Exclusion Criteria:

* Participation in any interventional trial in the previous 30 days.
* Women in the childbearing age.
* Any history of intracranial hemorrhage, subarachnoid hemorrhage, neoplasm, arteriovenous malformation or aneurysm.
* Conditions that, according to the judgment of the investigator, might impose an additional risk to any individual stroke patient when receiving study medication (this applied to patients on platelet-function inhibitors as well).
* MRI exclusion criteria: Evidence of ICH, Evidence of SAH, Signs of extensive early infarction on DWI assessed by evidence of involvement of \>1/3 of the middle cerebral artery (MCA) territory. No perfusion deficit, Internal carotid artery (ICA) occlusion ipsilateral to stroke lesion without additional ipsilateral MCA, anterior cerebral artery (ACA) or posterior cerebral artery (PCA) occlusion. Any intracranial pathology that would interfere with the MRI assessment of acute ischemic stroke.
Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes

People with newly diagnosed type 2 diabetes treated with metformin that have not reached their HbA1c target (42-64 mmol/mol) will be recruited to the study. If they fulfill the inclusion and none of the exclusion criteria, they will be, after signing informed consent, randomized to a six-month intervention with either pioglitazone, empagliflozin or semaglutide. Fat biopsies are obtained from the subcutaneous abdominal area before and after a hyperinsulinemic-euglycemic clamp at baseline and after six months. Participants are regularly followed during this the intervention. The overall goal is to determine how antidiabetic-drugs affect white adipose tissue cellularity and whether adipose heterogeneity impacts on drug response. The primary outcome measure is the change in fat tissue lipolysis (glycerol release in isolated fat cells after hormone stimulation) before and after treatment.

A detailed description of the protocol has been approved by the Swedish Medical Products Agency and the study is registered as EudraCT: 2021-002367-21.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* BMI 25 kg/m2 or higher
* HbA1c 42 mmol/mol or higher
* For fertile women, effective contraception

Exclusion Criteria:

* HbA1c 65 mmol/mol or higher
* Established cardiovascular disease and/or heart failure
* Severe psychiatric condition
* Active alcoholism
* Insulin treatment
* Anticoagulant therapy (vitamin K antagonists or equivalent)
* Pregnancy, lactation
* Positive GAD or IA2 antibodies
* Low C-peptide/glucose ratio (less than 2 measured as pmol/mg per dL)
* NT-proBNP above the upper normal reference value
* Kidney disease
* Liver disease or hepatic values over twice the upper reference value
* Severe concomitant disease including ongoing cancer
Machine Learning to Predict Lymph Node Metastasis in T1 Esophageal Squamous Cell Carcinoma

Existing models do poorly when it comes to quantifying the risk of Lymph node metastases (LNM). This study generated elastic net regression (ELR), random forest (RF), extreme gradient boosting (XGB), and a combined (ensemble) model of these for LNM in patients with T1 esophageal squamous cell carcinoma.

Lymph node metastases (LNM) is a relatively uncommon but possible complication of T1 esophageal squamous cell carcinoma (ESCC). Existing models do poorly when it comes to quantifying this risk. This study aimed to develop a machine learning model for LNM in patients with T1 esophageal squamous cell carcinoma.

Patients with T1 squamous cell carcinoma treated with surgery between January 2010 and September 2021 from 3 institutions were included in this study. Machine-learning models were developed using data on patients' age and sex, depth of tumor invasion, tumor size, tumor location, macroscopic tumor type, lymphatic and vascular invasion, and histologic grade. Elastic net regression (ELR), random forest (RF), extreme gradient boosting (XGB), and a combined (ensemble) model of these was generated. Use Area Under Curve (AUC) to evaluate the predictive ability of the model. The contribution to the model of each factor was calculated. In order to better meet clinical needs, the investigators have designed the model as a user-friendly website.

Eligibility Criteria:
Inclusion Criteria:

* (I) thoracic ESCC
* (II) no history of concomitant or prior malignancy
* (III) tumor with pT1 staging
* (IV) 15 or more lymph nodes examined

Exclusion Criteria:

* underwent neoadjuvant treatment or endoscopic submucosal dissection before surgery
Acute Low Back Pain: Causes, Mechanisms, Treatment and Followup

The purpose of this study is to investigate acute low back pain, its origin, mechanisms, the cause of pain, evaluation of treatments and development. Employees from a large local manufacturing company are sent for a complete orthopedic and pain evaluation immediately after onset of acute low back pain. Thereafter, the included patients are allocated either to the advice to stay as active as possible in spite of the pain or to adjust their activity to the pain. Pain intensity and physical activity are followed prospectively over seven days using a diary and a pedometer.

The purpose of this study is to investigate acute low back pain, its origin, mechanisms, the cause of pain, evaluation of treatments and development. Employees from a large local manufacturing company are sent for a complete orthopedic and pain evaluation immediately after onset of acute low back pain. The patients go through x-ray examinations, physical examinations, they complete a battery of questionnaires covering history of acute low back pain, lifestyle characteristics, work place factors, psychosocial factors, and indicate pain intensity and pain locations. Thereafter the patients are randomly allocated to one of two treatment advices: stay active as much as possible in spite of pain or adjust the activity to the pain. During seven days after the medical examination the patients wear a pedometer attached to the waist and annotate the number of steps and pain intensity, pain location and pain-related disability in a diary. A numeric graphic scale is used for pain intensity. Work absenteeism and sick leave due to the current acute back pain is collected from the company records. Immediate inclusion after pain onset is facilitated with continuous communication with the manufactory company. Physical activity and pain development over the seven days is investigated statistically using linear mixed models for repeated measures.

Eligibility Criteria:
Inclusion Criteria:

* Severe acute low back pain, duration within 24h after onset, pain exceeds 50mm on the visual analog scale (VAS)

Exclusion Criteria:

* Sick-leave because of low back pain or in spine in the last month
Effect of Smartphone Usage

Screen time is defined as the time spent on many electronic and technological devices such as laptops, tablets, televisions, game consoles, and smartphones. The largest portion of screen time is made up of smartphones, which are currently used at very high rates. The increase in screen time, which describes the time an individual spends in front of technological devices, can pave the way for various physical problems when not controlled. The most important of these problems caused by excessive screen use due to increased smartphone use is postural disorders. Based on this, the original value of this research is to examine and reveal the effects of smartphone use on balance and dual-task performance. Scientific data can be reached on the negative effects of increased screen use caused by smartphone use.

Screen time is defined as the time spent on many electronic and technological devices such as laptops, tablets, televisions, game consoles, and smartphones. The largest portion of screen time is made up of smartphones, which are currently used at very high rates. The increase in screen time, which describes the time an individual spends in front of technological devices, can pave the way for various physical problems when not controlled. The most important of these problems caused by excessive screen use due to the increase in smartphone usage times is postural disorders. It was planned to examine and reveal the effects of smartphone usage time on balance and dual-task performance. This study was planned as a prospective cross-sectional study. It was planned to evaluate at least 50 participants. The average smartphone usage times of the participants will be recorded. Static and dynamic balance tests (Y Balance Test and Flamingo Test) will be applied and a cognitive task will be added to these tests by including smartphone usage, thus evaluating dual-task performance. The obtained data will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-30
* Have a smartphone usage period of the last 7 days

Exclusion Criteria:

* Having a severe medical condition
* Having any disease that may affect cognitive level
* Having any disease that may affect balance
* Being pregnant
* Having an orthopedic or neurological surgery within the last year
* Using a mobility assistive device
* Not owning a smartphone
Endocervical Evaluation With the Curette Versus Cytobrush for the Diagnosis of Dysplasia of the Uterine Cervix

OBJECTIVE: to compare endocervical brushing with endocervical curettage with respect to diagnostic and patient discomfort.

METHOD: women referred to colposcopy because of abnormal Papanicolaou tests will be randomized to endocervical sampling with either a metal curette (endocervical curettage -ECC) or and endocervical brush. All samples will be submitted for histological study.


Eligibility Criteria:
Inclusion Criteria:

* French-speaking
* 21 years or older
* Attending our colposcopy clinic
* Need for endocervical evaluation
* Full autonomy or capacity to understand the procedures

Exclusion Criteria:

* Pregnancy
* Absence of uterus
* History of DES exposure in utero
Effects of Mandibular Exercises Effect on Pain Perception and Sensitivity in Mandibular Myofascial Pain

The effectiveness of mandibular exercises as a treatment of muscular Orofacial Pain is yet unknown. This study hypothesized that training exercises can be an effective therapy improving pain perception.

Temporomandibular disorders (TMDs) represent heterogeneous musculoskeletal disorders, where most common presentation is mandibular muscle pain, which is also more common among female than men. Many interventions have been proposed for this pain control, regarding drugs, oral splints, relaxing exercises and self awareness but little is known about mandibular active contraction exercises. The aim of this study is to evaluate the effects of mandibular exercises in pain perception and sensitivity in women. A double blind randomized clinical trial will be conducted among fertile university student women with Oral Contraceptives (OC) use -to control hormonal influences-, with report of facial pain and myofascial pain diagnosis (RDC/TMD). They will be assessed in Visual analogue scale (VAS), sleep quality, Pressure Pain Threshold (PPT) and pressure pain tolerance (PPTol), and then allocated in one of the three interventions for 21 days: isometric mandibular active exercises over silicone bars; video-guided isotonic mandibular contractions over cloth pegs or counseling about disorders nature as passive comparison. After 21 days, VAS, PPT and PPTol in bilateral temporalis and masseter muscles will be assessed for a second time,) and compared with initial pain status.

Data will be entered by single blind operator, and will be open for quality auditing. Site monitoring will be performed by the University clinical entities.

Data checks will be also performed as planned. Descriptive and analytical statistics will be performed to address the primary and secondary objectives.

Eligibility Criteria:
Inclusion Criteria:

* Temporomandibular Myofascial pain diagnosis
* Oral contraceptives consumption
* Facial pain for at least 3 months (and at least 10 of the last 30 days at Visit 0)
* Agrees to terms for continuing/discontinuing certain prescription/over-the-counter pain medications.

Exclusion Criteria:

* Other orofacial pain diagnosis
* Oral surgery within 6 months
* Treatment for pain management within past 30 days
* Neurological or psychiatric disorders
* Orthodontic treatment
* History of pregnancy, pregnancy or breastfeeding.
An Open-Label Treatment Protocol With UX003 rhGUS Enzyme Replacement Therapy for an Advanced Stage MPS 7 Patient

Emergency access granted to treat a single patient with advanced Mucopolysaccharidosis Type 7 with UX003 Recombinant Human Beta-glucuronidase (rhGUS) Enzyme Replacement Therapy via IV administration every other week (QOW) for up to 144 weeks.


Eligibility Criteria:
Inclusion Criteria:

* 1 specific patient
* Confirmed diagnosis of MPS 7 based on leukocyte or fibroblast glucuronidase enzyme assay or genetic testing confirming diagnosis.
* Written informed consent of parent(s) or legal guardian(s)
Comparison of the Effects of Deep and Moderate Neuromuscular Blockade on Optic Nerve Sheath Diameter

Increased intracranial pressure (IICP) is a common problem in traumatic brain injuries and many medical diseases. Early recognition of IICP can save lives. Several invasive and non-invasive methods have been described for IICP diagnosis. In recent years, ultrasonographic measurement of optic nerve sheath diameter (ONSD) has become a popular method due to its high sensitivity and specificity for IICP estimation. Studies have shown that ONSD's ultrasonographic measurement correlates with the IICP and can detect intracranial hypertension. The ONSD measurement has advantages such as being easily applied by the clinician at the bedside, being non-invasive, providing immediate results, reproducibility and low cost. It is known that artificial carbon dioxide pneumoperitoneum created in laparoscopic surgeries increases intracranial pressure.However, it is not easy to estimate the degree of changes in ICP during laparoscopic surgery under general anesthesia. In the literature, there are many studies on the sonographic measurement of optic nerve sheath diameter to evaluate the effects of trendelenburg position on intracranial pressure with the use of different anesthetic drugs in laparoscopic surgeries. In addition, there are studies reporting that deep neuromuscular blockade in laparoscopic surgeries increases surgical vision and decreases analgesic requirement in postoperative period. The relationship between neuromuscular block level and intracranial pressure is not clear. From this point of view, the investigators would like to evaluate the effect of moderate and deep neuromuscular block level on intracranial pressure by sonographic measurement of optic nerve sheath diameter in laparoscopic cholecystectomy operations performed with standard pressure artificial carbon dioxide pneumoperitoneum.


Eligibility Criteria:
Inclusion Criteria:

* Between 18-65 years
* ASA I-II
* Patients undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

* Intracranial hypertension
* Glaucoma
* Chronic obstructive pulmonary disease
* Pseudotumor cerebri
* Cerebral venous sinus thrombosis
* İntraoperative hemodynamic instability
* Mean arterial blood pressure\<65 mmHg
* Body mass index\> 35
* Asthma
* Kidney or liver problems
* Lupus
* Crohn's disease or ulcerative colitis
* Previously had any gastrointestinal bleeding
* Hypertension
* Peripheral arterial disease
* Angina, heart attacks, or mild or moderate heart failure
* Stroke
Study of Resilience and Loneliness in Youth (18 - 25 Years Old) During the COVID-19 Pandemic Lock-down Measures.

The outbreak linked to SARS-CoV-2 pandemic resulted in lock-down measures in almost all European countries.

This online survey assesses these measures implications on Mental Health in emerging adults.

The questionnaires evaluate two psychometric variables (Resilience and Loneliness) and Mental Health status (mental health professional help-seeking, use of psychotropic drugs, or possible diagnosis) before and during Lock-down Measures.

At least 600 healthy participants aged form 18 to 25 years old will be attended to fill the survey during the SARS-CoV2 Pandemic Lock-down Measures.


Eligibility Criteria:
Inclusion Criteria:

* French-speaking or Italian-speaking
* Subjects who accepted to participated to the online survey
* Inhabitants of a European country where SARS-CoV2 Pandemic Lock-down Measures are underway
* Survey filling date up to one week after the end of Lock-down Measures in the Country of residence

Exclusion Criteria:

* Incomplete surveys
Sex Differences in Neural Response to Cannabidiol

This is a randomized, double-blind, within-subjects, cross-over design to assess neural changes following a single dose of cannabidiol (CBD) (600mg) versus placebo among healthy female volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Female, aged 18-65
4. In good general health as evidenced by medical history and medically eligible to receive CBD, as determined by the licensed physician, Dr. Ayana Jordan
5. Body Mass Index between 18.5 and 30
6. For females of reproductive potential: agreement to use highly effective contraception during study participation and/or negative pregnancy test prior to fMRI scanning

Exclusion Criteria:

1. Recent use of cannabis (any past month use)
2. Lifetime history of cannabis use disorder
3. Lifetime history of chronic pain disorder
4. Current DSM-5 disorder, as determined via Structured Clinical Interview (SCID-5)
5. Presence of any contraindication to MRI scanning
6. Known allergic reactions to cannabidiol
7. Lifetime use of Epidiolex
8. Currently taking any medications that could interact with cannabidiol
9. Current smoker or tobacco use \>1x/week
10. Not fluent in English
11. Less than 6th grade reading level