cyrilzakka/clinical-trials huggingface dataset:
Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning

The aim of the present study is to assess the availability of cannabinoid receptors (CB1R) in the human brain. CB1R are present in everyone's brain, regardless of whether or not someone has used cannabis. The investigators will image brain cannabinoid receptors using Positron Emission Tomography (PET) imaging and the radioligand OMAR, in healthy individuals and several conditions including 1) cannabis use disorders, 2) psychotic disorders, 3) prodrome of psychotic illness and 4) individuals with a family history of alcoholism, 5) Post-Traumatic Stress Disorder 6) Opioid Use Disorder using the PET imaging agent or radiotracer, \[11C\]OMAR. This will allow us to characterize the number and distribution of CB1R in these conditions. It is likely that the list of conditions will be expanded after the collection of pilot data and as new data on cannabinoids receptor function and psychiatric disorders becomes available.

Those in the cannabis us disorder arm of the study will have a PET scan on at least three occasions: once while smoking as usual, once after 48-hours of abstinence from cannabis, and a final time after 4 weeks of abstinence. Additional scans may be conducted within the 4 weeks and the last scan may be conducted well beyond 4 weeks. Similarly, while most schizophrenia patients may get scanned just once, a subgroup of patients may get scanned more than once. For example to tease out the effects of medications, unmedicated patients may get scanned while unmedicated and again after treatment with antipsychotic medications. Similarly prodromes may get scanned while in the prodromal stage off medications, on medications and after conversion to schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Males ages 18-55
* For cannabis users:
* Willing to abstain from cannabis use for four weeks
* For schizophrenia:
* Meets DSM-IV-TR criteria for schizophrenia or schizoaffective disorder
* For prodrome for psychotic illness:
* Meets SIPS criteria for prodromal syndrome
* For family history positive:
* First degree relative with alcoholism
* For Post-Traumatic Stress Disorder
* Meets DSM-IV-TR criteria for PTSD
* For OUD
* Meets DSM-IV-TR criteria for Opioid Use Disorder

Exclusion Criteria:

* Current neuro-psychiatric illness (including cannabis dependence) or severe systemic disease. Cannabis use disorder is permitted in the cannabis dependent group. Schizophrenia and schizoaffective disorder is permitted in the schizophrenia group. Psychotic symptoms are permitted in the prodromal group. Post-Traumatic Stress Disorder is permitted in the PTSD group and Opioid Use Disorder is permitted in the OUD group.
* Presence of ferromagnetic metal in the body or heart pacemaker
* Have had exposure to ionizing radiation that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits
* Are claustrophobic
BRIUS Vs FFA Efficiency

The purpose of this study is to compare the Full Fixed Preadjusted appliances (regular braces) when to the BRIUS system.

This is a randomized controlled trial which aims to identify the effectiveness of alignment in the BRIUS group when compared to the full fixed appliance group.

The secondary aim of the study is to identify any difference in discomfort experienced by the patients when undergoing treatment using the two appliances

The investigators also aim to quantify the extent of tooth movement that is achieved through each appliance within a given time frame

Eligibility Criteria:
Inclusion Criteria:

* 10 to 18 years old
* Angle Class I and Cl II (up to half cusp) molar and canine relationship.
* Fully erupted permanent dentition (excluding third molars).
* Crowding of 7 mm or less.
* Must be able to maintain good oral hygiene assessed by the orthodontist during their visits.

Exclusion Criteria:

* Previous history of orthodontic treatment or orthognathic surgery
* Subjects who require extractions or orthognathic surgery
* Multiple missed appointments
* Deteriorating oral hygiene and craniofacial syndromes or disorders
* Severe gag reflex resulting from the use of intra-oral scanners
Endometrial Receptivity After GnRH Agonist Triggering

Conventional luteal phase support after human chorionic gonadotrophin (hCG) triggering in women undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) provides adequate pregnancy rates and live birth rates, but Ovarian hyperstimulation syndrome (OHSS) still occurs in 1-3% of the patients. If gonadotropin-releasing hormone agonist (GnRHa) are used instead of hCG, OHSS does not occur, but clinical results are somehow diminished.

By testing different luteal support protocols on women undergoing GnRHa triggering, the investigators aim to find out which protocol resembles the most the gene expression profile observed after hCG triggering and conventional luteal phase support, in order to choose it as the most adequate in terms of endometrium receptivity and safety (OHSS incidence).


Eligibility Criteria:
Inclusion criteria :

* Healthy oocyte donor women
* Aged 18-35 years
* With a menstrual cycle length of 26-35 days
* Normal ultrasound scan of uterus and ovaries
* Normal basal hormones
* No contraindication for controlled ovarian stimulation (COS)
* Willing to participate in the study and providing written informed consent.

Exclusion Criteria:

* Subjects with current or previous history of an endocrine abnormality
* Subjects with an abnormal outcome of blood biochemistry or hematology
* Subjects with an abnormal cervical smear
* Subjects with a chronic disease
* Subjects with any relevant ovarian-, tubal- or uterine-pathology that could interfere with the COS treatment
* Pregnancy
* Subjects who had a previous history of ovarian hyperresponse or ovarian hyperstimulation syndrome (OHSS), polycystic ovary syndrome (PCOS) or a basal antral follicle count (AFC) of more than 20 on ultrasound (11 mm, both ovaries combined) .
* Previous low ovarian response to FSH or hMG treatment (i.e. cycle cancelled due to insufficient ovarian response or less than 6 oocytes obtained).
* A history of recurrent miscarriage,
* Smoking more than 10 cigarettes per day.
* Not willing to comply with study procedures
3 Fixation Devices in Laparoscopic Ventral Herniotomy

Clinical, controlled, randomized, prospective study. Ventral hernias between 2(1.5)cm and 7 cm, laparoscopic surgery with intraperitoneal onlay mesh.

Three randomization groups of 25 patients giving a total of 75 patients. Mesh is fixated with either Protack, Securestrap or Glubran II. Primary outcome: postoperative pain on the 2nd postoperative day. Secondary outcomes: pain, quality of life, recurrence and adhesions at 1, 6, 12, 24, 36, 48 and 60 months postoperative.

see brief summary

Eligibility Criteria:
Inclusion Criteria:

* ventral hernia 2(1,5) \< dia \> 7 cm
* danish speaking
* of sound mind
* bmi \< 35
* ASA 3 or less, no contra indication against laparoscopy

Exclusion Criteria:

* other size hernias,
* no danish,
* bmi \> 35
A Clinical Trial to Evaluate the Sensitivity and Specificity of "WAYMED Endo" Compared to the Endoscopists in Classifying Early Gastric Cancer (EGC) Based on the Depth of Invasion in Endoscopic Images

The purpose of this clinical trial is to prove that the prediction capability of 'WAYMED endo' is superior to that of the endoscopists in classifying EGC based on the depth of invasion categories in gastro-endoscopic images.

The computer-aided detection·diagnosis software is an Artificial Intelligence (AI) software used to assist medical specialists in diagnostic decisions by automatically classifying EGC based on the depth of invasion categories in gastro-endoscopic images and displaying the results and possibilities on the User Interface (UI).

This clinical trial aims to evaluate the sensitivity and specificity of 'WAYMED endo' compared to that of endoscopists in classifying EGC based on the depth of invasion categories in gastro-endoscopic images. It is designed as a retrospective, single-center, double-arm, double-blind (endoscopist, investigational medical device applicator), controlled, and pivotal trial. Medical data collected retrospectively from subjects who underwent Esophagogastroduodenoscopy (EGD) and biopsy are screened. As a result of screening, medical data that meet all inclusion/exclusion criteria are enrolled and assigned to the trial and control groups.

In the trial group, the investigational medical device is applied to the images, while the endoscopists interpret the images in the control group. The Reference Standard Establishment Committee records the reference standard results as either "Mucosa (mucosal invasion)" or "Submucosa (submucosal invasion)", based on the depth of invasion of the lesion, and marks the detected lesion area with an oval on the image. The reference standard results are blinded, so they cannot be disclosed to the endoscopists or the investigational medical device applicator.

The primary endpoint includes the sensitivity (%) and specificity (%) of "WAYMED endo" and the endoscopists in classifying EGC based on the depth of invasion categories ("Mucosa" or "Submucosa") as confirmed by the reference standard. The secondary endpoint includes the accuracy (%) of "WAYMED endo" and the endoscopists in accurately classifying all early gastric cancer images as either "Mucosa" or "Submucosa", based on the depth of invasion categories as confirmed through pathological examination.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 19 years or older who underwent EGD 2. Confirmed the presence of gastric cancer through the Electronic Medical Record (EMR), including reports of EGD or pathology

1. M ("Mucosa (mucosal invasion)"): Medical data of early gastric cancer patients with confirmed "Mucosa" for the depth of invasion category in the EMR.
2. SM ("Submucosa (submucosal invasion)"): Medical data of early gastric cancer patients with confirmed "Submucosa" for the depth of invasion category in the EMR.

Exclusion Criteria:

1. Absence of pathological results for the lesion
2. History of gastrectomy
3. Judged as inappropriate for inclusion by the investigator
A Study About Low Blood Pressure in Patients With Primary Immunodeficiency Disease Treated With Immune Globulin Products

This is a safety study to evaluate the risk of low blood pressure in subjects with Primary Immune Deficiency disorder (PID) treated with Bivigam™ or another commercial product under real world conditions. No study medication will be provided to subjects in this study. Study physicians will make all treatment decisions according to their usual practice and will provide prescriptions for his/her subjects, as appropriate. The only addition is the collection and structured documentation of data generated through usual practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients with PID diagnosis
* Current subjects requiring treatment with an IGIV

Exclusion Criteria:

* Patients not meeting inclusion criteria
Novel Bidirectional Peripheral Artery Cannula in Minimally Invasive Aortic Valve Surgery

The aim of this study is to evaluate the safety and efficacy of the novel bidirectional cannula (BiflowTM, LivaNova, Italy) with specific design to ensure stable distal perfusion compared to conventional cannula with downstream line in patients undergoing femoral arterial cannulation for cardiopulmonary bypass during minimally invasive surgery

The femoral artery is a common site for peripheral cannulation in patients requiring cardiopulmonary bypass (CPB) for minimally invasive cardiac surgical procedures (MICS), redo cardiac surgical procedures, and procedures involving the thoracic aorta Limb ischemia is the most common acute and late vascular complication and has been reported in 10% to 70% of patients Traditional methods to maintain distal perfusion include the use of a downstream cannula or sewing on a side graft, but these techniques are cumbersome, time-consuming, and require additional equipment As a result, current practice is relying on the very small volume of blood that will flow around the cannula and collateral circulation to keep the leg viable, but by the time ischemia is clinically evident, irreversible cell damage may have already occurred The aim of this study is to evaluate the safety and efficacy of the novel bidirectional cannula (BiflowTM, LivaNova, Italy) with specific design to ensure stable distal perfusion compared to conventional cannula with downstream line in patients undergoing femoral arterial cannulation for CPB during MICS

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing minimally invasvie aortic valve replacement 50-90 years of age

Exclusion Criteria:

* previous vascular surgery of the femoral artery, emergency cardiac surgery including type A aortic dissections, internal diameter of the common femoral artery less than 7.5 mm and where the clinician felt adequate flow rates and line pressures would not be achievable with a 19F cannula, because of the patient's weight and body surface area
A Trial of Mechanical Axis With Soft Tissue Release Balancing vs Functional Alignment With Bony Release Balancing in Total Knee Replacement Using Stryker's Mako Robot

This study is a prospective, randomized, longitudinal study of the clinical outcomes of osteoarthritis patients treated by two different alignment philosophies for total knee replacement. All patients will be treated with the same knee system, implanted using MAKO robotic-arm assisted technology.


Eligibility Criteria:
Inclusion Criteria:

* The patient is a male or non-pregnant female between the ages of 40-80 years.
* The patient requires a primary total knee replacement and is indicated for robotic-assisted surgery.
* Patient is deemed appropriate for a cruciate retaining knee replacement.
* The patient has a primary diagnosis of osteoarthritis (OA).
* The patient has intact collateral ligaments.
* The patient is able to undergo CT scanning of the affected limb.
* The patient has signed the study specific, ethics-approved, Informed Consent document.
* The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.

Exclusion Criteria:

* The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint.
* Patient has had a previous osteotomy around the knee.
* The patient is morbidly obese (BMI ≥ 40).
* The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.
* The patient has a varus/valgus deformity ≥ 15°.
* The patient has a fixed flexion deformity ≥ 15°.
* The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
* The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
* The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
* Patient has a cognitive impairment, an intellectual disability or a mental illness.
* The patient is pregnant.
* The patient has metal hardware present in the region of the hip, knee or ankle (as this is known to create geometrical distortion in the region of the implant).
Comparing QLB Type I Block to Intraperitoneal Instillation Added to Wound Infiltration for Postoperative Cesarian Pain

This study aimed to compare the efficacy of local anaesthetic infiltration into all layers of the anterior abdominal wall with peritoneal instillation and QLB type I for pain reduction in women undergoing elective cesarean section under spinal anaesthesia.

This study will be conducted as a prospective randomized, controlled, double-blind trial following the approval of the ethical committee at Atatürk University Medical Faculty Hospital and after obtaining written consent from the participating patients. The study will include pregnant women aged 18 to 50 with American Society of Anesthesiologists (ASA) II classification, full-term and singleton pregnancies planned to undergo cesarean section using Pfannenstiel incision with spinal anaesthesia. Using a randomisation procedure, the participants will be allocated into two equal groups: Group IPLA+ LWI and Group QLB.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 to 50
* American Society of Anesthesiologists (ASA) II classification,
* full-term and singleton pregnancies planned to undergo cesarean section
* using Pfannenstiel incision
* spinal anaesthesia

Exclusion Criteria:

* whom neuraxial anaesthesia is contraindicated,
* those who are allergic to drugs to be used in the study,
* who refused to participate in the study,
* those with BMI\>35 kg/m2,
* ASA score ≥3 or higher,
* diabetes mellitus, preeclampsia, cardiovascular disease, chronic pain and neuropathic pain,
* individuals who have received opioids during the surgical procedure for intraoperative pain,
* patients who have undergone abdominal surgery,
* patients who have experienced a transition from spinal anaesthesia to general anaesthesia due to failure,
* those with excessive bleeding during the operation,
* who have uterine atony,
* those who have a drain placed in the area to be infiltrated,
* those who cannot understand the Visual Analog Scale (VAS),
* who have a history of drug addiction and psychiatric disorder
Termination of Persistent Atrial Fibrillation by Catheter Ablation

This is a prospective, multicenter, cohort study aims to demonstrate the role of termination of AF in ablation for persistent atrial fibrillation, and evaluate the clinical outcomes in patients with or without AF termination.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 80 years old; 2. Persistent AF; 3. Nonresponse or intolerance to ≥1 antiarrhythmic drug.

Exclusion Criteria:

1. With uncontrolled congestive heart failure;
2. Having significant valvular disease and/or prosthetic heart valve(s);
3. With myocardial infarction or stroke within 6 months of screening;
4. With Significant congenital heart disease;
5. Ejection fraction was \<40% measured by echocardiography;
6. Allergic to contrast media;
7. Contraindication to anticoagulation medications;
8. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
9. Left atrial (LA) thrombus measured by pre-procedure transesophageal echocardiography;
10. Having any contraindication to right or left sided heart catheterization; 11. Previous atrial fibrillation ablation;

12. Presence of an implanted cardioverter-defibrillator; 13. Any cardiac surgery within the past 2 months; 14. Poor general health; 15.Life expectancy less than 6 months.
A Study to Evaluate Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects With Albuminuria and Moderately Decreased GFR

The purpose of this study is to evaluate pharmacodynamics, safety, tolerability and pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria and Moderately Decreased GFR


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Type II diabetic nephropathy, who have been treated with angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin II receptor blocker (ARB)
* Glycosylated haemoglobin (HbA1c) ≤10.5%
* An estimated glomerular filtration rate (eGFR) ≥30-\<60 mL/min/1.73m\^2
* Subject with albuminuria

Exclusion Criteria:

* History of Type I diabetes, pancreas or β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
* Serum potassium level \<3.5 or \>5.0 mmol/L
* Subjects who had acute kidney injury (AKI) within 3 months prior to baseline or have undergone renal dialysis at any time prior to randomisation
* Subjects with a history of renal transplant
* Subjects with clinically significant hypotension
Decompressive Craniectomy in Patients With Cerebellar Infarction

The investigators aimed to evaluate the outcome in participants up to 80 years of age with space-occupying cerebellar infarction treated with suboccipital decompressive craniectomy (SDC) compared to medical therapy alone.

This trial is a prospective, randomized, controlled, clinical trial based on a stroke center. The primary end point was survival with favorable outcome, defined as a score of 0 to 3 on the mRS at 12 months (±30 days) after randomization (defined by a score of 0 to 3 on the modified Rankin scale (mRS), which ranges from 0 \[no symptoms\] to 6 \[death\]). Secondary outcomes included death, Barthel Index, baseline stroke severity NIHSS (National Institute of Health Stroke Scale), and SF-36 at 6 months and 1-year after randomization. The variables for subgroup analysis were age, sex, time to randomization, lesion volume, brainstem involvement, hemorrhagic transformation.

Eligibility Criteria:
Inclusion Criteria:

* The presence of cerebellar territory infarction with an NIHSS score ≥8.
* Initial Glasgow Coma Scale (GCS) score \<9 on admission and clinical deterioration (a score of ≥ 1 decrease on GCS score) within 48 hours from onset.
* Decrease in the level of consciousness to a score of ≥ 1 on item 1a (level of consciousness) of the NIHSS, rapid deterioration to coma.

Exclusion Criteria:

* Prestroke mRS score ≥2.
* Prestroke score on the Barthel Index \<95.
* Score on the Glasgow Coma Scale ≤6.
* Both pupils fixed and dilated.
* Any other coincidental brain lesion that might affect outcome.
* Space-occupying hemorrhagic transformation of the infarct.
* Pregnancy.
* Life expectancy \<3 years.
Asthma With Nasal Polyposis

Asthma is often associated with various comorbidities that may influence its clinical expression. Among those, chronic rhinosinusitis with nasal polyposis (CRSwNP) is observed in 5% of cases. Asthmatic patients with CRSwNP appear to have more severe and poorly controlled asthma, as well as greater bronchial and systemic inflammation, especially those using inhaled corticosteroids as control medication. However, this remains to be validated. In the last decade, there has been interest labeled for phenotyping of asthma and CRSwNP. However, there is scarce data on the phenotype of asthma with CRSwNP.

This study aims to describe the phenotype of asthmatic patients with CRSwNP according to the clinical, physiological and inflammatory characteristics and whether there is a more severe phenotype related to the dose of inhaled corticosteroids and the percentage of induced sputum eosinophils.

This study will compare the characteristics of asthmatic patients with CRSwNP with those without CRSwNP.

Eligibility Criteria:
Inclusion Criteria:

* 1. Aged 18 years and over 2. With a proven diagnosis of asthma as defined by one of the above criteria of current guidelines:

  1. Forced expiratory volume in one second (FEV1) increase by at least 12% (and ≥200 ml) after administration of a bronchodilator
  2. Current asthma symptoms and a methacholine provocative concentration inducing a 20% fall in FEV1 (PC20) \<16 mg/ml
  3. A respirologist's current diagnosis of asthma found in the patient's medical report 3. Non-smokers or smokers/ex-smokers defined as someone with a smoking history \<10 pack-years 4. Stable asthma and asthma medication for at least 4 weeks before data analysis 5. Written informed consent obtained for inclusion in the database

     Patients with CRSwNP

     1. With a proven diagnosis of CRSwNP, based on endoscopy and defined as the presence of endoscopically visible bilateral polyps growing from the middle meatus with or without involvement of the nasal cavities

     Exclusion Criteria:
     1. Any respiratory disease apart from asthma and CRSwNP
     2. Current or ex-smokers should not have a smoking history ≥10 pack-years before data analysis. Patients who administer nicotine in other forms (patches, chew tobacco, e-cigarette, etc.) will be excluded
     3. Unstable asthma medication \<4 weeks before index date
     4. Asthma exacerbation (see definition below) \<4 weeks before index date
     5. Respiratory tract infection \<4 weeks before index date