cyrilzakka/clinical-trials huggingface dataset:
Betamethasone and Severity of Hyaline Membrane Disease

Primary purpose: to study the relationship between betamethasone placental transfer and the occurrence and severity of the Hyaline Membrane Disease.

β-Mhyalines is a prospective multicentric non interventional study. One hundred fifty pregnant women at risk of premature delivery, in the framework of Hyaline Membrane Disease of the neonate, will receive 2 intramuscular injections of Celesten (betamethasone) at 24 hours interval. Plasma samples will be collected: 2 in the mother before delivery, one maternal and one cord samples at delivery. Concentrations will be measured and analyzed using a population approach. A ratio between neonatal and maternal exposure will be calculated to represent placental transfer. The effect of covariates (genetic polymorphism for CYP3A4, CYP3A5, P-glycoprotein..., and others variables as gestational age, bodyweight at birth, apgar score, co-medication, maternal disease) will be tested to explain the variability of placental transfer. The relationship between placental transfer and the occurrence and severity of the Hyaline Membrane Disease will then be study, in order to target betamethasone maternal concentration and thus to optimize the antenatal dose to administer to the mother in the framework of Hyaline Membrane Disease.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who received at least a first injection of Celesten in the prevention of MMH.
* A one-term\> 27 SA,
* Major Patients \> or = 18 years old
* Informed Consent Form signed

Exclusion Criteria:

* Patients undergoing treatment with corticosteroids in the long term
Transcranial Magnetic Stimulation (TMS) for Upper Limb Dysfunction in Spinal Cord Injury: a Feasibility Study

This study will investigate how repetitive transcranial magnetic stimulation (TMS) using intermittent theta-burst stimulation (iTBS) paradigm affects sensorimotor dysfunction such as pain, spasticity, motor weakness and sensory loss. TMS is technique which allows non-invasive stimulation of the cortex, and can modulate activity of neurons. The purpose of this study will be to assess the feasibility of using TMS with iTBS paradigm to treat sensorimotor dysfunction in people with incomplete spinal cord injury affecting the upper limbs.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-70 years old inclusive
* Traumatic and non-traumatic tetraplegic patient following chronic incomplete (AIS C or D) SCI injury (sustained at least three months ago)
* Referred to the Sheffield Spinal Injuries Centre
* Be able to provide written informed consent or verbal consent in the presence of an independent witness
* Spasticity affecting upper limbs with a Modified Ashworth scale (MAS) 2 or above
* Stable medical treatment for at least 1 week before and 1 week after TMS application
* Stable medical condition

Exclusion Criteria:

* Aged less than 18 years old
* Lack the mental capacity to consent
* Ventilated patients with sedation
* Very acute (\<3 months) SCI patients
* Implanted electrical devices such as pacemakers, Concomitant neurological conditions, including any history of epilepsy
* Significant joint-related limitation of passive range of movement
* Unable to attend all TMS sessions
* Pregnancy
* Inability to tolerate TBS
* Significant upper limb contractures
Two Bag System for Hydration in Diabetes

This is a randomized controlled trial comparing the time needed to get the conditions to space hourly controls to controls every 4 hours, using the one bag system versus the two bags system, in the initial treatment of children with diabetic ketoacidosis. After fast infusion of isotonic saline solution (20 ml/kg) to prevent shock, the administration of maintenance fluids and insulin therapy is indicated. Hourly plasmatic levels of glucose controls could determine changes in glucose IV administration. On using the classic one bag system each change determine a bag change. Using the two bag system allows to deliver the patient the appropriate glucose infusion in less time.

The treatment of children with diabetic ketoacidosis includes fast infusion of isotonic saline solution to prevent shock (20 ml/kg), and then the administration of maintenance fluids and insulin therapy according to hourly plasmatic glucose levels controls. Finally, after patients stabilization, controls becomes less frequents (each 4 hours).

During the stabilization period infusion of glucose is calculated hourly according to plasmatic glucose levels. These modifications in IV infusion can be very frequent, sometimes by the hour, requiring preparation of a new solution for hydration (in a new bag).

This procedure takes time, during which the patient continues receiving the previous IV infusion until the changes are effectively made. Therefore, usually changes are not strictly hourly, interfering with the adjustment of the organism to the above mentioned changes.

The 2 bag system consists in using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line. Using this system allows that changes needed in the administration of fluids and/or dextrose, may be easily and instantly managed by delivering different amounts from each bag to achieve the desired infusion rate without having to replace the bag.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 1 to 18 years old
* Diabetic ketoacidosis(plasmatic glucose \> 250mg/dl, pH \< 7.3, bicarbonate \< 15mmol/L, ketonuria and glycosuria)

Exclusion Criteria:

* Patients who already received insulin in the Emergency Department.
* Patients who, because of their clinical condition, require admission to intensive care unit.
Etiology and Prognosis of sICH Based on Hemorrhage Location

The investigators retrospectively collected participants with spontaneous cerebral hemorrhage(sICH) from January 2015 to December 2019 for training and internal validation. Clinical and imaging data were collected. Modified Rankin Scale (mRS) scores were determined good outcome as "mRS = 0-2", poor outcome as "mRS = 3-6". The location features of sICH were extracted by symptom mapping. Noncontrast computed tomography images of patients and hematoma masks were registered with standard human brain templates to identify specific affected brain regions. Then a probability map of hemorrhage for different causes and prognosis is generated. PyRadiomics was used to extract the radiomic features, integrate radiomic and clinical features into multiple logistic regression models, and develop and validate optimal etiological and prognostic models. Further tests were performed in an independent cohort. The area under the working characteristic curve (AUC), sensibility, specificity were used to evaluate the reliability of the model.


Eligibility Criteria:
Inclusion Criteria:

* The confirmation of intracranial hemorrhage was achieved through NCCT.

Exclusion Criteria:

* They presented with secondary hemorrhage resulting from head trauma, hemorrhagic transformation of ischemic infarction, brain tumors, or exhibited abnormalities in blood coagulation, liver, kidney function, or were subject to drug-induced cerebral hemorrhage
* Only postoperative CT images were available
* Lost follow-up records
* CT image artifacts
Extension Study to Evaluate Safety and Efficacy of Jaktinib in Patients With Active Ankylosing Spondylitis(AS)

The purpose of this study is to determine if Jaktinib is safe and effective in participants with active ankylosing spondylitis.


Eligibility Criteria:
Inclusion Criteria:

* The investigators concluded that the participants continued to benefit from treatment with Jaktinib.
* The participants have been fully informed and voluntarily signed informed consent.
* The participants completed the ZGJAK029 study for 16 weeks of treatment and visitation and had good compliance.
* The interval between the participants' first dose and the last dose of ZGJAK029 ≤ 4 weeks.

Exclusion Criteria:

* There were any grade ≥3 adverse events within 4 weeks prior to enrollment and no return to grade 1 or normal.
* Within 4 weeks prior to enrollment, participants had the following infectious diseases: tuberculosis infection requiring treatment; HIV-positive, syphilis, HBV infection, HCV infection.
* The investigators considered participants unsuitable for this study.
Study to Evaluate the Safety, Efficacy of Tegoprazan for the Prevention of PUD in Patients on Treatment With NSAIDs

This study is designed to confirm the non-inferiority of Tegoprazan 25 mg, compared to Lansoprazole 15 mg, to prevent gastroduodenal ulcers and verify the safety of tegoprazan following oral administration of tegoprazan 25 mg QD or lansoprazole 15 mg QD in patients on long-term treatment with NSAIDs.

This is a double-blind, randomized, active-controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 25 mg, lansoprazole 15 mg).

Eligibility Criteria:
Inclusion Criteria:

* ≥60 years of age, or ≥20 years of age with a history of gastroduodenal ulcers (gastric and/or duodenal ulcers) at screening
* Requires continued treatment with NSAIDs for ≥24 weeks

Exclusion Criteria:

* Has an active stage (A1, A2) or healing stage (H1, H2) of gastroduodenal ulcers per the Sakita-Miwa classification identified by upper GI endoscopy at screening
* Has uncontrolled severe hypertension
* Has severe heart failure, congestive heart failure (NYHA Ⅱ to Ⅳ), ischemic heart disease (unstable angina, myocardial infarction), or peripheral artery disease, or has undergone coronary artery bypass graft (CABG) who is considered ineligible for treatment with NSAIDs
* Has a positive H. pylori test at screening
Evaluating Autologous Stromal Vascular Fraction in Subjects with Vocal Fold Scar

The purpose of this research study is to assess if autologous Stromal Vascular Fraction (SVF) taken from the stomach or hips can help heal vocal fold scars.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Subject's age between 18 and \< 80-years-old
* Voice handicap index greater than 10/40
* Scarred vocal folds or congenital sulcus or after vocal fold surgery (Scarring will be scored during examination and identification of scarred vocal folds and hoarseness. This criterion includes the lack of or decreased mucosal wave of the vocal fold during videostroboscopy exam. Scoring of scar based on laryngoscopic exam: Type I: atrophy of lamina propria with/without affected epithelium. Type II: the epithelium, lamina propria, and muscle are affected. Type III: scar located on the anterior commissure. Type IV: this category includes extended scar formation in both anteroposterior and rostro-caudal axis, with significant loss of vocal fold mass)
* Unilateral or Bilateral vocal fold scarring
* At least 1-year delay after initial surgery
* Negative pregnancy test and contraception for woman of childbearing age. Women of childbearing age must use contraception at least 4 months pre and post SVF administration.

Exclusion Criteria:

* Refusal of speech therapy
* History of malignant lesion or severe dysplasia of the scarred vocal fold
* Contraindication to anesthesia, anticoagulant treatment, coagulation disorders, active infectious disease
* Refusal or inability to comply with study procedures
* Pregnant and lactating woman
* Major chronic medical condition that could affect treatment or quality of SVF product. These include:

  * Current treatment or within 6 months of last treatment for cancer.
  * Blindness
  * Known history of Dementia,
  * Known history of Kidney Disease
  * Known history of Cerebral Vascular Accident or Stroke
* Known history of Diabetes
* Abnormal screening lab. If the laboratory reports a single, non-clinically relevant, non-life-threatening result for any of these studies and is the only excluding factor it may be repeated 1 week later if the subject wishes. Normalization of that laboratory study will then be considered non-exclusionary.
* Post-Radiation scarring of vocal folds.
Sperm Preparation Prior to Intrauterine Insemination Study

This is a randomized controlled trial comparing density gradient centrifugation and microfluidic sperm sorting in patients undergoing intrauterine insemination to evaluate cumulative pregnancy outcomes.

Study participants will be randomized to either standard sperm preparation (density gradient centrifugation) versus sperm preparation with the Zymot Multi sperm preparation device for their three month intrauterine insemination treatment course. Patients will follow standard treatment plans designed by their fertility physician and will be followed until referred for prenatal care at 8-10 weeks of pregnancy to determine pregnancy outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing intrauterine insemination
* Patient assigned female at birth with age \<41

Exclusion Criteria:

* Any significant disease or psychiatric disorder that would interfere with the consenting process
* Prior intrauterine insemination
* Use of frozen donor sperm
* Non-English speaker
Ketamine as an Anaesthetic Agent in Electroconvulsive Therapy (ECT)

Research into the mechanisms underlying memory impairment in ECT suggests that its development may be prevented by the administration of certain medications at the time of ECT treatment. For example there are reasons to believe that ketamine, also used as an anaesthetic agent, may have such protective properties.

In this clinical study patients undergoing a course of ECT will be offered the opportunity to receive a small dose of ketamine (or a placebo) as part of their anaesthetic at the time of ECT treatment. Mood changes and any memory changes will be evaluated to see if the subjects who received ketamine had less memory side effects than those who did not, while still improving their depression.

This study will report on two related trials. In the outpatient trial, patients will be administered adjunctive ketamine at two different doses (0.25mg/kg; 0.5mg/kg), and a placebo (saline), across 3 consecutive sessions within their regular maintenance ECT course. The order of conditions will be randomised across participants. Patients will be required to learn some words and faces 20 minutes prior to ECT, and complete a detailed cognitive battery 4 hours after ECT on each of the 3 occasions. The purpose of this trial is to determine whether ketamine is superior to placebo in reducing cognitive impairment following ECT and what the optimal dose of ketamine is for minimising cognitive and other side effects. Projected sample for this trial is N = 17.

In the inpatient trial, patients will be randomly assigned to receive ketamine or placebo for the duration of the acute ECT course. Patients will be administered a detailed cognitive battery the day before commencing ECT treatment, the day after the 6th treatment, and 1-3 days and 1 month following the end of the acute ECT course. The purpose of this trial is to examine whether patients in the ketamine condition had superior cognitive outcomes to those in the placebo condition during and following a course of ECT. In addition, depressive symptomatology will be examined throughout the ECT course to determine whether ketamine anaesthesia during ECT has antidepressant, as well as, cognitive benefits. Projected sample for this trial is N = 34.

This entry gives details of the main clinical trial: The effects of ketamine across a course of ECT.

Eligibility Criteria:
Inclusion Criteria:

* Satisfy DSM-IV-TR criteria for Major Depressive Episode
* 18 years or over
* Does not have a diagnosis of schizophrenia, schizoaffective disorder, rapid cycling bipolar disorder, or current psychotic symptoms
* No known sensitivity to ketamine
* No ECT in the last 3 months
* No drug or alcohol abuse in the last 12 months
* Able to give informed consent
* Score at least 24 on Mini Mental State Examination
Prone Position and Respiratory Outcomes in Non-Intubated COVID-19 PatiEnts The "PRONE" Study

The overall objective of this study is to determine whether a positional maneuver (e.g., prone positioning) decreases the need for escalation of respiratory-related care in patients with coronavirus (COVID-19) pneumonia.

As the initial outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the disease it causes, coronavirus disease 2019 (COVID-19) has spread beyond Wuhan, China it has become a pandemic affecting over 178 countries. Of patients admitted to the ICU, upwards of 85% developed the acute respiratory distress syndrome (ARDS) and most if not all required mechanical ventilation. The beneficial effects of prone positioning for ARDS have been well described. Coupling the reported benefits of prone positioning in COVID-19 associated ARDS patients with the known beneficial effects of early prone-positioning in the treatment of ARDS, it is not surprising that many hospital systems are advocating prone positioning for treatment of ARDS in patients with COVID-19. However, as the pandemic continues to progress in the United States and the number of new cases grows as new clusters emerge, the possibility of 'rationing' ventilators becomes more real. Therefore, therapies that prevent the need for mechanical ventilation are desperately needed. Given the distinct benefit that patients with COVID-19 have with prone positioning, the overarching hypothesis of this trial is that patients with high risk for respiratory failure may also benefit from prone positioning.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* COVID-19 positive by nasopharyngeal swab or serostatus
* Use of supplemental oxygen OR respiratory rate ≥ 20

Exclusion Criteria:

* BMI ≥ 45 kg/m2
* Pregnancy
* Chest tube placement
* Hemodynamic instability with mean arterial pressure \< 60 mmHg
* Thoracic or abdominal wounds
* Chest wall deformities
* Vertebral column deformities that would preclude prone positioning
* Facial trauma or surgery in the last 30 days
* Established diagnosis of interstitial lung disease
* Prior single or double lung transplant
* Surgery for spine, femur, or pelvis in the last 3 months
* Thoracic or cardiac surgery in the last 30 days
* Pacemaker placement last 7 days
Comparison of the Non-Dominant Hands of Pianists and the Dominant Hands of Individuals Who Do Not Play Instruments

The aim of this study is to compare the non-dominant hands of pianists with the dominant hands of individuals who do not play an instrument in terms of skill and reaction time.

The study was conducted at Haliç University on 15 individuals who have been playing the piano for at least five years (Group 1) and 15 individuals who have never played an instrument in their lives (Group 2). The individuals who agreed to participate in the study and signed the consent form were administered the "Edinburgh Hand Preference Questionnaire" to determine hand dominance, the "Nine-Hole Peg Test" to evaluate hand dexterity, and the "Nelson Hand Reaction Test" to determine reaction time. We believe that the results of our study will provide new perspectives to the literature.Statistical analysis will be performed with SPSS 24.0 program. If the data is parametric, paired sample t-test will be used for within-group evaluation; independent sample t-test will be used for between-group evaluation. If the data is non-parametric, Wilson test will be used for within-group evaluation and Mann Whitney U test will be used for between-group evaluation.

Eligibility Criteria:
Inclusion Criteria:

For Group 1:

* Volunteering to participate in the study
* Being between the ages of 18-30
* Having played an instrument professionally for at least 3 years

For Group 2:

* Volunteering to participate in the study
* Being between the ages of 18-30
* Having not played/does not play any instrument before or currently

Exclusion Criteria:

For Group 1:

* Being able to play an instrument other than the piano professionally
* Having a surgical operation involving the shoulder, arm, forearm or hand in the last 6 months
* Having any systemic, genetic, neurological or orthopedic problems that would prevent the tests

For Group 2:

* Having a surgical operation involving the shoulder, arm, forearm or hand in the last 6 months
* Having any systemic, genetic, neurological or orthopedic problems that would prevent the tests
Pain Perception in Protection of the Palatal Donor Area After Harvesting a Free Gingival Graft Using Flowable Resin Versus a Self-adhesive Dressing

The use of a connective tissue graft harvested from the palate is currently one of the most effective and predictable alternatives for the correction of periodontal and peri-implant defects, but the discomfort generated in the palate is sometimes greater than mucogingival surgery. For this reason, we found the need to use different materials for palatal protection. In one group we will use light-cured fluid resin compared to another group a self-adhesive dressing to check which of these materials provides less postoperative pain generated by the harvest of a free gingival graft.

The postoperative pain generated by the harvest of a free gingival graft for the correction of periodontal or peri-implant defects, it\&#39;s greater when it is not adequately protected and until the reepithelialization of the area is complete. For this reason, it was decided to use two materials to compare the effectiveness in reducing postoperative pain in grafts larger than 15 mm. A control group will be treated with a hemostatic collagen sponge and photocured fluid resin, adhered to the palatal surfaces of the neighboring teeth using an adhesive protocol and X-shaped sutures. Another experimental group will be treated with a hemostatic sponge and placement of a self-adhesive dressing stabilized by X-shaped sutures to ensure its permanence in the mouth. The participants will fill out a daily visual analog scale form for 14 days until the removal of the materials. Finally, the results will be tabulated and compared to provide a conclusion of our study.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Patients with plaque control less than 20%
* Patients with bleeding on probing less than 10%
* Patients in need of periodontal or peri-implant surgery in the upper or lower jaw
* Not having previous surgeries in the donor area

Exclusion Criteria:

* Pregnant or breastfeeding patients
* Patients with lesions in the palate
* Patients who use prostheses that cover the palate
* Patients with active periodontal disease
* Patients who smoke
* Patients with systemic diseases
* Torus palatinus
* Patients with a history of chemotherapy and radiotherapy