cyrilzakka/clinical-trials huggingface dataset:
Maternal Perception of Fetal Movements Evaluation Using and Analyzing the Variables of Antepartum Computerized Cardiotocography: An Exploratory Study.

Several studies analysed the association of fetal movement counting with perinatal mortality and fetal outcomes. However, no one examined the relationship of the maternal perception of fetal movement with the fetal wellbeing quantifies through computerised cardiotocography.

Our study evaluates the correlation between the maternal perception of fetal movement and antepartum computerised cardiotocography parameters.


Eligibility Criteria:
Inclusion Criteria:

* nonlaboring term singleton pregnancies (37 0/7 - 41 6/7 weeks of gestation)

Exclusion Criteria:

* fetal malformations, stillbirths, preterm deliveries
GEnetic Testing in Elective Single Embryo Transfer (GETSET): A Randomized Clinical Trial

The GETSET trial is a prospective randomized trial designed to evaluate the clinical outcomes of incorporating preimplantation genetic testing for aneuploidies (PGT-A) in elective single embryo transfer in women between 35 and 40 years of age.

In this randomized controlled trial, a total of 240 patients divided evenly across the two participating IVF center will be recruited. Patients will be randomized to a control and to a treatment group, each containing 120 participants.

Only patients with at least one evaluable blastocyst will be randomized. Patients will undergo ovarian hyper-stimulation, oocyte retrieval, fertilization and embryo culture per standard clinical protocol determined by IVF center.

In the control arm, patients will undergo a single frozen embryo transferof the untested, best quality blastocyst. All other blastocysts with lower morphology will undergo trophectoderm biopsy on day 5, 6 or 7 and will be frozen. PGT-A results of the untransferred embryos will be revealed to the patient AFTER the outcome of the initial ET is known.

In the experimental arm, all embryos will be cultured to blastocyst and all viable blastocysts will undergo trophectoderm biopsy and PGT-A. PGT-A will be performed regardless of the number of blastocysts available. Patients will undergo frozen transfer of the single, best quality euploid blastocyst. If the initial transfer results in a non-conception cycle and additional embryos are available for transfer.

Eligibility Criteria:
Inclusion Criteria:

Women undergoing IVF of between 35 and 40 years of age at IVF cycle start Utilization of Intracytoplasmic Sperm Injection ICSI (recommended) or Traditional IVF Utilization of ejaculated or testicular sperm Utilization of autologous or donor sperm All Controlled Ovarian Hyperstimulation (COH) protocols

Exclusion Criteria:

Utilization of donor oocytes Utilization of gestational carrier Recurrent Pregnancy Loss (RPL) defined as ≥ 3 consecutive miscarriages Recurrent Implantation Failure (RIF) defined as ≥ 3 more failed embryo transfers Preimplantation genetic testing for monogenic/single gene disorders (PGT-M) Translocation carriers
Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial

The purpose of the study is to determine if providing participants with alcohol-related liver disease with tailored alcohol use treatment options is feasible and acceptable in order to increase their engagement with treatment and reduce alcohol use. This is an important area to study to help create ways to increase participants' knowledge about different treatment options as well as increase likelihood of seeking and participating in alcohol use disorder treatments.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled at University of Michigan general hepatology clinics or inpatient wards
* Documented diagnosis of alcohol-associated cirrhosis or alcoholic hepatitis or alcohol-related liver disease of any stage
* Drinking of any amount of alcohol within the 6 months prior to recruitment
* No alcohol use treatment within the past 1 month
* Access to a phone for purposes of follow-up

Exclusion Criteria:

* Active alcohol use treatment
* Undergoing active evaluation for liver transplantation, is listed for liver transplant, or is post-transplantation.
* Is enrolled in the multidisciplinary alcohol-related liver disease clinic at Michigan Medicine
Adenosine and Magnesium Sulphate as Adjuvants for PECS Block.

Pectoral nerve block (PECS) has been used for post-operative pain relief in patients undergoing breast surgery. It has been shown that adenosine has an effect on pain modulation. Magnesium sulphate has been used as an adjuvant to local anaesthetics in many nerve block techniques. We hypothesised that adenosine may affect the PECS block quality. We aimed to compare the effect of adding adenosine to the local anaesthetic and compare its effect to magnesium sulphate when used for PECS block.

The present study was conducted on 90 adult patients aged between 20 and 65 years old. Patients scheduled for modified radical mastectomy with axillary clearance surgery American Society of Anaesthetist (ASA) classes I, II, and III patients were included in the study.

Patients were randomly allocated into on of three groups according to the adjuvant used with the local anaesthetic, 30 patients in each group using a computerised program. All patients received PECS block. Group (C) received PECS block with 0.25% bupivacaine (control group), group (A) bupivacaine with added adenosine, and group (M) bupivacaine with added magnesium sulphate.

The local anaesthetic syringes were prepared by an independent anaesthetist. The researchers and the patients were blinded to the local anaesthetic adjuvant in the syringes. All patients received 30 ml local anaesthetic for PECS. The 30 ml local anaesthetic used for each patient contained bupivacaine hydrochloride 0.25%, bupivacaine hydrochloride 0.25% and 12 mg adenosine, and bupivacaine hydrochloride 0.25% and 500 mg magnesium sulphate for groups C, A, and M respectively.

Patients' demographic data were collected including age, BMI, ASA, and duration of surgery. In the post- anesthetic care unit (PACU) the visual analogue score (VAS) was assessed on arrival and then every 15 minutes. The duration and the quality of the block was recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for modified radical mastectomy with axillary clearance surgery ASA classes I, II, and III patients were included in the study

Exclusion Criteria:

* 1) contraindications for regional anesthesia such as coagulopathy, local infection and fungating breast cancer, 2) history of allergy to the medications used in the study, 3) patient with history of drug abuse, 4) previous breast surgery except for diagnostic biopsies, 5) history of treatment for a chronic pain condition, 6) psychiatric disorder.
The Use of Indocyanine Green to Visualize Blood Flow to the Gastrojejunostomy During Bariatric Surgery.

This is an interventional pilot study aimed to evaluate the use of NIF imaging as an intraoperative aid to assess the anastomotic blood flow to the gastric pouch and gastrojejunostomy during Roux-en-Y gastric bypass surgery and to determine its long-term impact on the rate of marginal ulceration, leaks and stricture.

The purpose of this study is to examine intraoperative usefulness of near-infrared light fluorescence imaging with a contrast agent called indocyanine green to improve visualization of blood flow to a surgical connection between the small intestine and stomach (gastrojejunostomy) in patients undergoing gastric bypass surgery. ICG will be given prior to and after making the gastrojejunostomy to examine blood flow and then a subjective perfusion score will be given by the surgeon and assistant during the surgery.

Patients will be recruited before the laparoscopic Roux-en-Y gastric bypass surgery and the study data will be collected prospectively through standard bariatric follow up visits up to 2 years. A mid-term analysis of the procedure and patient outcomes will be performed for quality assurance purposes when half the study patients have undergone intraoperative ICG use. The ICG will be not given if a patient is allergic to sodium iodide or has a history of allergy to iodides because of the risk of a severe allergic reaction.

Participants will be assigned an identifying number to protect confidentiality. Descriptive univariate and multivariate statistical analysis will be performed on all patients satisfying the study's inclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Capacity to provide informed consent.
* Over the Age of 18.
* Eligible for bariatric surgery in Ontario and deemed an appropriate candidate for RYGB surgery by the bariatric program.
* Commit to follow-up within the bariatric program, including behavioral and dietary modifications designed to aid in sustained weight-loss.
* Treatment of marginal ulcer with the revisional surgery.

Exclusion Criteria:

* Not willing to participate in study
* Contraindication to, or not planned to undergo RYGB
* Known allergy to indocyanine green or Sodium Iodide
* Is participant pregnant or planning to get pregnant in next two years
* Ongoing substance abuse or active smoking
* Bleeding diathesis or Coagulopathy
* Unwilling to take PPI medication Post operatively
A Retrospective Clinical Records Review of Patients Diagnosed With Gastrointestinal Stromal Tumour at Two Tertiary Institutes in Singapore

To review the characteristics and treatment of gastrointestinal tumours at the two tertiary centres in Singapore

A retrospective clinical records review of patients diagnosed with gastrointestinal stromal tumour (GIST) in the two tertiary centres in Singapore i.e. Singapore General Hospital and National University Hospital.

Gastrointestinal tumours are the most common soft-tissue tumours of the gastrointestinal tracts. Remarkable progress has been made during the last several years in the diagnosis and treatment of GIST. Understanding of the molecular pathogenesis of GIST which is linked to deregulated KIT tyrosine-kinase activity has improved diagnosis, such that GIST is now more frequently and specifically identified. More importantly, systemic tyrosine kinase inhibitor, imatinib, has been used successfully in the treatment of GIST patients with advanced or unresectable disease.

GIST has been reviewed in the Western literature but there is a lack of Asian data. The review will help us to better understand the disease in our population.Furthermore we will also examine several unresolved issues in the Western literature by looking into our local data. These include required duration of imatinib therapy, role of imatinib in the adjuvant setting (application of chemotherapy after macroscopically complete removal of tumour) and role of combination therapies.

The medical records of all patients diagnosed with the disease at the two centres will be reviewed.

Analysis of the results aims to:

1. to compare the characteristics of the GIST (epidemiology, site, morphology, immunohistochemistry profile) in our centres compared to the well-published literature.
2. to compare the treatment regimen and results of our centres compared to others
3. to review the role of chemotherapy in the adjuvant settings in the centres.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Gastrointestinal stromal tumor.
Study by Metagenomics and Culturomicsapproaches of Bacterial and Viral Flora of Diabetic Foot Infection

This work also highlights the presence of an unknown virus double-stranded DNA. In this project we propose 1) incorporating a bank of 150 samples from patients with diabetic foot infection in grades 2-4; 2) to study the microbial flora of a selection of 50 diabetic feet previously untreated with antibiotics for bacterial metagenomics, viral metagenomics and a minimum of 10 per culturomique; 3) to evaluate the use of targeted quantitative PCR on the most frequent new species frequency in the disease and incidentally get a sense of their role in the evolution and prognosis of the disease, including failures of and targeted antibiotic therapy on all 150 samples.

Patients will be included by the infectious and tropical diseases and diabetes services the Nîmes Teaching Hospital which have a large active file and proven expertise internationally in this pathology. The usual agents of infection will be searched by standard bacteriological techniques as part of the microbiological documentation of such cases and will be performed by the microbiology laboratory of CHU Nîmes which will freeze the rest of the sample to -80 ° C the will send it to the Marseille Microbiology Federation for realization of metagenomics-culturomics

Eligibility Criteria:
Inclusion Criteria:

* Patients were taken care by the services(departments) of Diabetology or Infectious diseases of the CHU(TEACHING HOSPITAL) of Nîmes, were hospitalized or were seen in consultation and presenting a wound chronicle of the foot and/or the ankle of Rank 2 - 4 (Classification of the IWGDF) \[IWGDF, Lipsky Clin Infect Dis on 2004\], inaugural or récidivante.

Exclusion Criteria:

* The patient participates in another study
* The patient is in period of exclusion determined by a previous study
* The patient is under protection(saving) of justice, under guardianship or under guardianship
* The patient refuses to sign the consent
* It turns out impossible to give about the lit(enlightened) information
* The patient is pregnant, parturiente, or she breast-feeds
* The patients having no wound
* The patients diabetics having a wound chronicles of Rank 1 (Classification of the IWGDF) \[IWGDF, Lipsky Clin Infect Dis on 2004\]
Prednisone Plus IVIg vs. Prednisone for ITP During Pregnancy

This is a prospective, randomized, open-label, multicenter clinical trial study to compare the efficacy and safety of prednisone plus IVIg to prednisone monotherapy in the treatment of immune thrombocytopenia (ITP) in pregnancy.

The investigators are undertaking a prospective, parallel group, multicenter, randomized controlled trial in pregnant patients with treat-naive ITP. A total of 100 participants are randomized to two groups with the 1:1 ratio: prednisone plus IVIg group versus prednisone monotherapy group. Participants will receive prednisone 20mg per day for 4 weeks plus IVIg 400mg/Kg (total dose ≤20g per day) for 5 days or prednisone 20mg monotherapy per day for 4 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Time to response and platelet counts of newborns are investigated. Adverse events including participants and their newborns are also recorded throughout and after the study.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-50 years old;
2. Meet the diagnostic criteria for immune thrombocytopenia;
3. Pregnant women with ITP without ITP-specific treatments during pregnancy;
4. Gestational weeks ≥12 weeks;
5. Platelet count \<30×10\^9/L, accompanied with or without bleeding symptoms.
6. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Have a known diagnosis of other autoimmune diseases, confirmed medical history or laboratory findings within positive anti-nuclear antibodies (\>1:80), anti-cardiolipin antibodies, lupus anticoagulant factors or direct Coombs' test.
2. Thrombocytopenia caused by pregnancy-specific conditions, such as gestational thrombocytopenia, preeclampsia, the HELLP syndrome and acute fatty liver of pregnancy.
3. Secondary thrombocytopenia such as drug-related thrombocytopenia, vaccine-related thrombocytopenia, lymphoproliferative disorders, severe infection, hepatic cirrhosis and so on.
4. With other underlying diseases that may cause thrombocytopenia, such as: malignant disease, megaloblastic anemia, aplastic anemia, myelodysplasia syndrome, myeloid fibrosis, disseminated intravascular coagulation, thrombotic thrombocytopenic purpura, Hemolytic uremic syndrome, disseminated intravascular coagulation and so on;
5. Current HIV infection or hepatitis B virus or hepatitis C virus infections;
6. With severe heart, kidney, liver or respiratory dysfunction;
7. With the medical history of mental illness;
8. Have allergic reaction to prednisone or IVIg;
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of SPN-810 in the treatment of impulsive aggression in patients with Attention-Deficit/Hyperactivity Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 297 subjects aged 6 to 12 years with ADHD and comorbid impulsive aggression will be recruited in this study. The frequency of impulsive aggression behaviors will be assessed as a primary outcome. Additionally, the severity and improvement in impulsive aggression and quality of life measures for the subject and caregiver will be assessed using validated scales.

This study is a randomized, placebo-controlled, double-blind, multicenter, parallel group, fixed dose study to demonstrate the efficacy, safety, and tolerability of SPN-810 in the treatment of IA in subjects aged 6 to 12 years with ADHD in conjunction with standard ADHD treatment.

Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy male or female subjects, age 6 to 12 years at the time of screening with a primary diagnosis of ADHD and currently receiving monotherapy treatment with an optimized FDA-approved ADHD medication.
* Impulsive aggression will be confirmed at screening using R-MOAS and Vitiello Aggression Scale.

Exclusion Criteria:

* Current or lifetime diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia or a related disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.
* Currently meeting DSM criteria for autism spectrum disorder, pervasive developmental disorder, obsessive-compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as the primary diagnosis.
* Known or suspected intelligence quotient (IQ) \< 70, suicidality, pregnancy, or substance or alcohol abuse.
Effect of Fluid Deresuscitation With Central Venous Pressure Target 0-4 mmHg in Septic Shock Patients

A scientific research to prove the safety and effectiveness of TVS 0 - 4 mmHg as a target of resuscitation using furosemide, to improve Perfused Vessel Density (PVD) \> 25 mm / mm2, AKI stage (based on KDIGO criteria), CI \> 2.5 cc / min / m2 , prevent the incidence of intubation, reduce the duration of ventilator use \<120 hours and reduce the length of ICU stay in patients with septic shock after resuscitation

The study aims to evaluate the effectiveness of deresuscitation with target CVP 0 - 4 mmHg on septic shock patients in the ICU on capillary perfusion density, AKI stage (based on KDIGO criteria), the incidence of intubation, duration of use of mechanical ventilation, and length of stay in the ICU which can reduce the number of morbidity and mortality.

The study evaluates the difference in capillary perfusion density, AKI stage (based on KDIGO criteria), and the Cardiac index value between groups septic shock patients with CVP 0-4 mmHg on the 7th day after deresuscitation compared with the control group (CVP 8-10 mmHg on the first 7th day after being given deresuscitation).

The study evaluates the difference in the number of intubation incidents, duration of use ventilators, and care in the ICU between groups of patients with septic shock CVP 0 - 4 on day 28 after being given a degree of comparison with a control group (CVP 8-10 mmHg on day 28th after being deresuscitation).

Eligibility Criteria:
Inclusion Criteria:

* Septic shock patients who meet the diagnosis criteria for quick SOFA and KDIGO 1 stage AKI (creatinine value 1.5 times OR creatinine value\> 0.3 initial OR urine production \<0.5 ml/kg/hour for 6-12 hours
* Patients, both men and women, in the age range of 18 - 60 years
* Patients who experience post clean operative sepsis
* Patients who agree to attend the study by signing informed consent

Exclusion Criteria:

* Patients with primary heart problems, right or heart failure suffer from congenital heart disease
* Have severe chronic obstructive pulmonary disease, patients with severe pleural effusion
* Patients who, based on ultrasound examination, found stones or tumors in the kidney during the study period
* CKD patients are based on history taking and physical examination
* DNR (do not resuscitate) patients
Intraperitoneal Bupivacaine With Magnesium or Nalbuphine for Postoperative Pain Control in Laparoscopic Hysterectomy

The purpose of this study is to compare between the addition of Mg sulphate or Nalbuphine to intraperitoneal bupivacaine installation in laparoscopic hysterectomy for postoperative pain control and their relative adverse effects.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I and II
* scheduled for laparoscopic hysterectomy

Exclusion Criteria:

* ASA physical status more than II
* Obesity (body mass index higher than 30 kg/ m2)
* History of chronic opioids intake
* Known hypomagnesaemia or hypermagnesaemia
* Chronic alcoholism
* Heart block
* Renal failure
* Patients with history of left ventricular failure
* Patients taking beta-blocking drugs
* Allergy to the study drugs
* if surgery changed to open hysterectomy,
Efficacy and Safety of PEMbrolizumab PD-L1-positive (>50% of Tumor Cells), Advanced NSCL Cancer(PEMBREIZH)

This study was a French multicentric cross-sectional study retrospectively of 108 consecutive advanced NSCLC patients with a PD-L1 TPS ≥50% and without EGFR/ALK aberrations treated by pembrolizumab in first line.


Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically confirmed NSCLC PD- L1 TPS ≥ 50% stage III and IV WHO performance status of 0, 1 or 2 adequate organ function

Exclusion Criteria:

* previous EGFR or ALK aberrations positive test for hepatitis B or C virus indicating acute or chronic infection known history of testing positive for human immunodeficiency virus (HIV) severe, uncontrolled autoimmune disease.