cyrilzakka/clinical-trials huggingface dataset:
Study of Serum Levels of Oxidative Stress Markers in Ovarian Hyperstimulation Patients

The aim of the study is to determine serum oxidative stress status by ischemia modified albumin (IMA), total antioxidant capacity (TAC), total oxidative capacity (TOS), oxidative stress capacity (OSI), and serum malondialdehyde (MDA) in patients with OHHS and control group. We also aim to reveal the association between serum levels of these factors and oocyte quality.

* Patients included in this study were assisted reproductive technique (ART) patients with moderate and severe OHSS who were hospitalized for management
* Control patients are selected from patients without signs of OHSS
* All patients are administered luteal long protocol for controlled ovarian stimulation. Pituitary down-regulation with SC injection of GnRH agonist (GnRH-a) (1 mg/day; Lucrin, Abbott Laboratories, North Chicago, IL) that was started on day 21 of the previous menstrual cycle. Subcutaneous administration of recombinant hFSH (Gonal-F, Laboratories Serono S.A., Aubonne, Switzerland) at dosages from 150-225 IU/day is initiated on the second or third day of menstruation.
* When there are at least two or three follicles \>17 mm in diameter, recombinant human chorionic gonadotropin (0.25 µgr ; Ovitrelle IM, Serono, Istanbul, Turkey) is applied subcutaneously 34-36 hours before oocyte retrieval.
* Serum samples are collected on day of HCG for study and control group patients.
* Serum levels of ischemia modified albumin (IMA), malondialdehyde (MDA), total oxidative capacity (TOS), total antioxidative capacity (TAS) and oxidative stress capacity (OSI) levels.
* This is a case control study
* Statistical analyses will be performed using student t-test and fisher chi-square test. The correlations between the serums IMA, TAC, TOC, OSI, and MDA levels will be examined in all study groups using Spearman correlation analysis.

Eligibility Criteria:
Inclusion Criteria:

• Patients in both groups are normoresponders or hyperresponders who will undergo assisted reproductive technology for male factor

Exclusion Criteria:

* known inherited or acquired thrombophilia
* previous thromboembolism
* previous, current or planned anti-thrombotic treatment
* first degree relatives with known genetic thrombophilia
* systemic diseases
* smoking.
Imaging Neuromelanin and Iron in Dystonia/Parkinsonism

To generate pilot data to investigate the potential to use in vivo iron- and neuromelanin-quantification as imaging tools for the diagnostic evaluation of movement disorders with predominant dystonia / parkinsonism. To this end we are planning to compare the MR imaging neuromelanin and iron-pattern and content in midbrain, striatum and further brain structures in clinically similar entities and respective, sex- and age-matched healthy controls.

Iron- or Neuromelanin-sensitive MR-imaging has not been consistently applied to the study of syndromes presenting with predominant dystonia/parkinsonism yet. We are planning to study the following groups, as they can often be very difficult to be distinguished from PD and in particular young-onset PD, on clinical grounds only:

* Dopa-responsive dystonia (DRD) can present similar to young-onset PD, but carries a completely different prognosis, necessitating different treatment requirements due to fundamentally different underlying physiology.
* Sporadic and Inherited dystonias (i.e. due to TorsinA (DYT1) and other gene mutations) often present with dystonia, particularly affecting the leg, which is clinically indistinguishable from young-onset PD.
* Young-onset PD, i.e. PD presenting with motor symptoms before 45 years of age, caused by a familiar gene mutation (PARKIN, Pink, DJ-1, PLA2G6, FBX07, ATP13A2, VPS13C, RAB39B, Lubag), often presents with predominant dystonia, particularly with leg-onset.
* NBIAs present with dystonia/parkinsonism: while basal ganglia iron accumulation is a known hallmark feature of the condition \[3\], the characteristics of neuromelanin regulation are unknown.
* Mitochondrial disease presenting with dystonia / parkinsonism (such as for example Leigh syndrome due to mutations in the Surf-1 gene or mutations m.3243A\>G or POLG) \[4\]
* Respective age- and sex-matched healthy controls This study is designed to produce pilot data on these disease entities. By potentially accelerating the diagnostic process and identification of disease entities, neurologists might be able to deliver more selective and dedicated treatment.

Furthermore, combining Neuromelanin- and iron-specific imaging will offer the possibility to study the condition- specific dynamics of iron homeostasis in these rare conditions.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of parkinsonism and/or dystonia due to
* dopa-responsive dystonia
* sporadic or inherited/genetic dystonia
* young-onset Parkinson's disease
* NBIA
* Mitochondrial disease

  * OR healthy controls
  * 18 to 60 years of age
  * able to give informed consent

Exclusion Criteria:

* Inability to tolerate 35min in an MRI machine
* Participated in a clinical drug trial up to 28 days before inclusion into the present study
* Contra-indications to 3T MRI on MRI safety grounds, such as presence of contra-indicated medical implants, as according to the established routine operating procedures for clinical MRI in the Lysholm Department of Neuroradiology at the National Hospital for Neurology and Neurosurgery.
Rhomboid Intercostal Block for Video Assisted Thoracic Surgery

Video assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. Analgesia management is very important for these patients in postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia and increased oxygen consumption.

Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. It has been reported that RIB may provide effective analgesia management for several surgeries like thoracotomy.

Following Video Assisted Thoracic Surgery Video assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. The advantages of VATS prodecures compared with open thoracotomy are rapid recovery, short hospital stay and low complication risk. Although VATS is less painful than thoracotomy, patients may feel severe pain during the first hours at postoperative period. Analgesia management is very important for these patients in postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia and increased oxygen consumption.

Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. Local anesthetic solution is administrated between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2-3 cm medially of the medial border of the scapula. RIB targets both the posterior rami and lateral cutaneous branches of the thoracic nerves and provides analgesia for the hemithorax from T2 to T9. It has been reported that RIB may provide effective analgesia management for several surgeries like thoracotomy.

The aim of this study is to evaluate the efficacy US-guided Rhomboid intercostal block compared to no intervention control group for postoperative analgesia management after VATS. The primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting) and complications due to block (pneumothorax, hematoma etc).

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) classification I-II
* Scheduled for VATS under general anesthesia

Exclusion Criteria:

* history of bleeding diathesis,
* receiving anticoagulant treatment,
* known local anesthetics and opioid allergy,
* infection of the skin at the site of the needle puncture,
* pregnancy or lactation,
* patients who do not accept the procedure
Treatment of Patients With Takayasu Arteritis Complicated With Pulmonary Artery Involvement

1. Evaluate the effect of medical treatment and percutaneous transluminal pulmonary angioplasty on takayasu arteritis with pulmonary artery involvement
2. evaluate the efficacy of FAPI in predicting the activity and treatment efficacy of takayasu arteritis with pulmonary artery involvement

At baseline, FAPI and FDG are performed to evaluate the activity of takayasu arteritis with pulmonary artery involvement. FAPI is also used to predict the treatment efficacy and prognosis of takayasu arteritis with pulmonary artery involvement.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with Takayasu arteries with pulmonary arteries involvement

Exclusion Criteria:

* Patients had pulmonary artery stenosis arising from CTEPH, fibrosing mediastinitis and congenital pulmonary artery stenosis
Italian Survey on Paediatric and Neonatal MRI

Paediatric anaesthesia care in the Magnetic Resonance Imaging is a challenge for clinicians. The recent debate about the role of anaesthetic agent on neural development, encouraged an evaluation of their actual activity in this environment. In this active call survey, the authors sought to delineate the Italian situation regarding national centers, staff involved, monitoring and tools available. The primary aim was to evaluate clinical practice in childhood management in Magnetic Resonance suite.

This study was designed as prospective phone survey on the setting of a complete sample of all national centers performing almost a paediatric discharge in the 2014, obtained from Italian Health Ministery registers.

The three section survey was fill out with the Physician in charge in Magnetic Resonance suite. The Main outcome was a descriptive and exploratory analyses about the organization setting of the Centers (procedures, performers, monitoring and tools).


Eligibility Criteria:
Inclusion Criteria:

* Uncooperative children \< 14 years old
* premature babies

Exclusion Criteria:

. collaborating children
Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies

A4091065 is a multicenter, prospective, cohort study with enhance physical an neurodevelopmental surveillance to characterize the outcomes related to the development of infants up to the age of 15 months who were potentially exposed to tanezumab, placebo or comparator via maternal exposure or in utero in any tanezumb study.

A4091065 is a long term observational follow up study of subjects from tanezumab interventional studies A4091056, A4091057, A4091058, A4091059, A4091061 or A4091063

Eligibility Criteria:
Inclusion Criteria:

* Subject is an infant born to a mother who was exposed to study drug on a tanezumab clinical study.
* The infant's mother (who was the tanezumab clinical study participant) must review, agree and sign an informed consent document explaining the details of the perinatal and post natal follow up. Where local regulations mandate, the male parent would also review and sign the informed consent.
* Parents or legal guardian must be willing and able to comply with scheduled visits and study procedures.

Exclusion Criteria:

* There are no exclusion criteria for participating in this study.
Brief Trainings to Buffer Against Acute Stress Effects

The purpose of this study is to evaluate and compare the effectiveness of several brief trainings based on contemplative practices and positive psychology to buffer against the negative effects that acute stress has on behavior and cognitive abilities. The investigators hypothesize that training will buffer against negative effects of acute stress.

Participants will be taught a stress reducing training (breath awareness, loving kindness practice, gratitude exercise) and will practice using this technique for 10-15 minutes. Following this, all participants will undergo the Cold Pressor Task (CPT) for up to 3 minutes.

Before and after these tasks, participant data related to attention, working memory, self regulation, affect, and prosociality will be collected.

Eligibility Criteria:
Inclusion Criteria:

* undergraduate psychology recruitment pool

Exclusion Criteria:

* non-native English speakers, pregnant women
Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN

MEIGES is a prospective, multicenter, randomized controlled clinical trial with the primary hypothesis that, STN-DBS is non-inferior to GPi-DBS for motor symptoms improvements at 365 days postoperatively in patients with idiopathic craniofacial dystonia.

Evaluating therapeutic effects of GPi-DBS vs. STN-DBS on patients with idiopathic craniofacial dystonia: Clinical data of patients at different treatment time points will be collected, using different clinical assessments. The main purpose is to assess whether STN-DBS is non-inferior to GPi-DBS for motor symptoms improvements at 365 days postoperatively in patients with idiopathic craniofacial dystonia.

Primary endpoints: Differences between the two groups in BFMDRS-M change scores in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS.

Secondary endpoints: Differences between the two groups in BFMDRS-M change scores in the stimulation state from before to 90, 180 days (±14 days) after STN-DBS and GPi-DBS. Differences between the two groups in BFMDRS-D, BDSI, JRS, MMSE, MoCA, HRSD, HAMA, SF-36 and programming parameters change scores in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS.

Eligibility Criteria:
Inclusion Criteria:

1. Adult subject (male or female, 18-75 years);
2. Diagnosed with idiopathic craniofacial dystonia for more than 1 year, including at least one of the eye and oromandibular region. Cervical dystonia may be present;
3. Treated with oral drugs or botulinum toxin injections, but with no satisfactory curative effect;
4. Normal cognitive function with MMSE score ≥ 24;
5. Informed consent signed.

Exclusion Criteria:

1. Only cervical dystonia, or combined with dystonia in other parts of the body other than the cervical region;
2. Diagnosed with other neuropsychiatric diseases(Alzheimer's disease, amyotrophic lateral sclerosis, Parkinson's disease, etc.);
3. History of brain surgery;
4. Severe depression with HRSD score ≥ 35;
5. Contraindications to neurosurgery(cerebral infarction, hydrocephalus, cerebral atrophy, sequelae of cerebrovascular disease, etc);
6. Contraindications to CT or MRI scanning(claustrophobia, etc);
7. pregnant or breastfeeding female, or has positive pregnancy test prior to randomization;
8. Contraindications to general anesthesia (severe arrhythmia, severe anemia, abnormal liver and kidney function, etc.);
9. Expected lifetime \< 12 months;
10. Currently receiving an investigational drug or device;
11. Other circumstances that the investigator considers unsuitable to participate in this study or that may pose a significant risk to the patient (inability to understand or comply with research procedures and follow-up, etc.).
Clinical Outcome Study of High-dose Meropenem in Sepsis and Septic Shock Patients

Sepsis and septic shock patients are considered to have a high risk of complications and death. Appropriate antimicrobial therapy plays an important role in determining outcomes in septic patients. However, pathophysiologic changes associated with critical illness have an impact on pharmacokinetics of antimicrobials. In addition, increasing bacterial resistance is also a growing concern, especially in intensive care units., Consequently, standard antimicrobial dose may not be sufficient to achieve pharmacokinetic/pharmacodynamic target in sepsis and septic shock patients. The purpose of this study is to compare a therapy between meropenem standard dose and meropenem high dose in the treatment of sepsis and septic shock


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years and older) with sepsis and/or septic shock according to SEPSIS-3 criteria and receive meropenem within 1 hour after diagnosis
* Informed consent signed by patient or their legally authorized representative

Exclusion Criteria:

* Subjects with infective endocarditis
* Subjects with central nervous system infection
* Subjects who requires surgical condition within 72 hours after randomization
* Subjects on extracorporeal membrane oxygenation (ECMO) within 3 days after randomization
* Subjects with active seizure
* History of receiving meropenem within 1 week prior to randomization
* Pregnancy women and lactation
* Known allergy to meropenem
* Not complete a 72-hour course of empirical meropenem treatment
Therapeutic Intervention Effects of rTMS on Children With Autism Spectrum Disorder

Autism spectrum disorder (ASD) is a common and complex neurodevelopmental disorder, which is characterized by impairments of social communication, social reciprocity, as well as restricted and repetitive behaviors (RRB). The unclear pathogenesis of ASD, its increasing prevalence, and its poor clinical diagnosis and treatment effect have caused a serious economic and mental burden on patients and their families. As a new non-invasive neuroelectrophysiological technique, transcranial magnetic stimulation (TMS) has been used more and more in the interventional treatment of autism. The current project aims to explore the influence of TMS on brain plasticity in autism by using TMS for interventional treatment of autism and provide guidelines for the intervention and treatment of autism by evaluating the efficiency of these methods.

Autism spectrum disorder (ASD) is a common and complex neurodevelopmental disorder, which is characterized by impairments of social communication, social reciprocity, as well as restricted and repetitive behaviors (RRB). The unclear pathogenesis of ASD, its increasing prevalence, and its poor clinical diagnosis and treatment effect have caused a serious economic and mental burden on patients and their families. As a new non-invasive neuroelectrophysiological technique, transcranial magnetic stimulation (TMS) has been used more and more in the interventional treatment of autism. The current project aims to explore the influence of TMS on brain plasticity in autism by using TMS for interventional treatment of autism and provide guidelines for the intervention and treatment of autism by evaluating the efficiency of these methods. Investigators conduct a randomized, double-blind, controlled TMS trial and collect the participants' stool samples and sequence the gut microbiome before the first magnetic resonance imaging(MRI) scan. Besides, investigators collect brain imaging data, eye movement data and clinical scale score before and after TMS trial to explore the changes of TMS treatment on clinical behavior and brain plasticity and provide guidelines for the intervention and treatment of autism.

Eligibility Criteria:
Inclusion Criteria:

* Age range from 2 to 8 years old. Clinical DSM-IV diagnosis of autism.

Exclusion Criteria:

* Subjects with other neurodevelopmental diseases Subjects with contraindications to MRI.
Naloxone, Hypoglycemia and Exercise

The overall objective of this project is to determine if the intranasal administration of naloxone during exercise will be a novel approach to preserve the counterregulatory response to hypoglycemia experienced the next day in patients with type 1 diabetes. Exercise induced autonomic failure contributes to the development of impaired awareness of hypoglycemia. Treatments that blunt the consequences of exercise induced autonomic failure, such as preserving the post-exercise counterregulatory response to hypoglycemia, may improve awareness of hypoglycemia. Naloxone, an opioid antagonist, is an extremely promising agent. In healthy volunteers, intravenous administration of naloxone during exercise preserved the counterregulatory response to hypoglycemia the following day (1). In this study, investigators will extend the clinical applicability by administering intranasal naloxone to individuals with type 1 diabetes. Specifically, the investigators will use a randomized, placebo controlled, crossover design to administer drug or placebo to patients with type 1 diabetes during acute exercise and assess the counterregulatory response to hypoglycemia the following day. The use of intranasal naloxone is a highly innovative aspect of this proposal. Intranasal naloxone translates readily to clinical use and, as demonstrated by the investigators preliminary data, achieves similar plasma drug concentrations as after IV administration.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes diagnosed on clinical grounds (history of DKA, use of insulin within 6 months of diagnosis)
* Diabetes duration \< 30 years (impaired awareness of hypoglycemia increases with duration so it will be more likely that shorter duration participants will have hypoglycemia awareness) but \> 2 years (to ensure that they have lost hypoglycemia induced glucagon secretion as is typical in patients who develop impaired awareness of hypoglycemia)
* Age 18 - 65 years
* Baseline hemoglobin A1C 6.8 - 9.0% (range selected to reduce the risk of hypoglycemia and uncontrolled diabetes in the weeks before the study, both of which may affect the responses to hypoglycemia)
* Awareness of hypoglycemia as verified by Cox questionnaire

Exclusion Criteria:

* History of stroke, seizures (other than those related to hypoglycemia), arrhythmias, active cardiac disease
* History of hypertension or blood pressure \> 140/95 mm Hg at screening visit
* Pregnancy or plan to become pregnant during the study period
* Health related limitations in exercise (including but not limited to: angina, uncontrolled asthma, peripheral arterial disease)
* Unwillingness to avoid exercise during the 7 days before each part of the study
* Concomitant medical problems that may prevent the participant from successfully completing the protocol
* Smoking as defined by 2 or more tobacco cigarettes a week
* Daily use of opioids or an opioid antagonist or use in the past two weeks
* Unwillingness to wear a continuous glucose monitor for one week before and one week after each part of the study
Comparison of Tibial Plateau Fractures Outcomes Treated With Non-locking and Locking Plate

this study will perform to compare the results and functional outcomes of tibial plateau fractures treated with non-locking and locking plate fixation.


Eligibility Criteria:
Inclusion Criteria:

* unilateral closed tibia plateau fracture

Exclusion Criteria:

* patients who have been treated with casting or screw
* history of diabetes mellitus
* evidences of pathological fractures