cyrilzakka/clinical-trials huggingface dataset:
Metabolic Characteristics of Sarcoma In Vivo Using HP 13-C Magnetic Resonance Spectroscopic Imaging (MRSI)

Investigators will determine whether MRSI using hyperpolarized \[1-13C\]pyruvate provide useful information of tumor malignancy in MRI-indeterminate cases. Metabolite maps of hyperpolarized \[1-13C\]lactate and H13CO3- produced from hyperpolarized \[1-13C\]pyruvate will be compared to the biopsy results of MRI-indeterminate patients and the 13C-maps of age-matched healthy subjects.

A non-randomized, interventional (nontherapeutic), feasibility trial to detect metabolic changes in participants with musculoskeletal sarcoma using hyperpolarized \[1-13C\]pyruvate Magnetic Resonance Spectroscopy Imaging (MRSI). All measured quantities will be tabulated and the analysis will be descriptive and obervational in nature.

Participants in this study will receive the study drug, hyperpolarized \[1-13C\]pyruvate, as a bolus injection during an MRSI of either a soft tissue sarcoma or healthy tissue. After the study drug injection and MRSI, participants will then receive contrast material, Gadavist, via injection during continuation the MRI.

Eligibility Criteria:
Inclusion Criteria:

SARCOMA patients:

- MRI indeterminate solid enhancing lesion in the pelvis or extremity.

ALL subjects:

* Age 18 through 100 years.
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Ability to understand and the willingness to sign a written informed consent.
* All races and ethnicities will be included; subjects must be able to read and speak the English or Spanish language.

Exclusion Criteria:

SARCOMA patients:

-Subjects who have had radiotherapy to the indeterminate lesion.

ALL subjects:

* Subjects who have had chemotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
* Subjects may not be receiving any other investigational agents.
* Any contraindication per MRI Screening form including implants contraindicated at 3T, pacemakers, implantable Cardioverter Defibrillator (ICD), claustrophobia.
* Metallic foreign bodies in the field of view which may interfere with MRI acquisitions.
* Since each subject is receiving a gadolinium based contrast agent intravenously, additional contraindications would include: eGFR ≤ 30 mL/min/1.73m2, sickle cell disease, or hemolytic anemia.
* Uncontrolled psychiatric illness/social situations that would limit compliance with study requirements.
* Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Role of ChatGPT in Vestibular Schwannoma Management

Previous studies have demonstrated that patients frequently undergo significant decision conflict regarding major medical decisions in otolaryngology. There lack validated tools available for decision support for patients. While limited evidence has demonstrated that clinical decision support tools can alleviate decision conflict for patients with diagnosis in otolaryngology, conversational language models were not employed in these studies and may provide additional benefit in this context. This study seeks to evaluate the efficacy of using ChatGPT, a conversational language model with basic clinical knowledge, in alleviating decision conflict for patients with new diagnosis in otolaryngology. For this pilot study, vestibular schwannoma, a benign tumor that develops on the vestibular nerve with known clinical equipoise, has been chosen for the initial study diagnosis. Efficacy will be evaluated by comparison of responses to the Decisional Conflict Scale (DCS) and Satisfaction with Decision (SWD) scores between a group given training in ChatGPT and a control group (no ChatGPT training).


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Diagnosed with vestibular schwannoma
* Have access to internet-enabled device that is compatible with ChatGPT

Exclusion Criteria:

* \< 18 years old
* patient without diagnosis of vestibular schwannoma
* patient does not have access to internet-enabled device
* patient who declines study participation
Nimotuzumab Combined With Chemoradiotherapy for Unresectable Locally Advanced Squamous Cell Lung Cancer

This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab in combined with chemoradiotherapy for unresectable,local advanced squamous cell lung cancer.

This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab combined with chemoradiotherapy for unresectable,locally advanced squamous cell lung cancer.

All patients were planned to receive radical dose of chest radiation and concurrent chemotherapy of weekly docetaxel and cisplatin, each of 1 day's duration.

Nimotuzumab group was treated with weekly nimotuzumab (200mg, IV) combined with chemoradiotherapy, while control group was treated with chemoradiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed squamous cell lung cancer
* patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* unresectable phase IIIA(N2) and IIIB lung cancer confirmed by CT or MRI
* ECOG performance status 0-1
* Previously treated with chemotherapy or treatment-naive
* no previous chest radiotherapy, immunotherapy or biotherapy.
* hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL
* serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min
* bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL
* FEV1 \>0.8 L
* CB6 within normal limits
* patients and their family signed the informed consents

Exclusion Criteria:

* adenosquamous carcinoma
* previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ
* contraindication for chemotherapy
* women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose
* women who has the probability of pregnancy without contraception
* tendency of hemorrhage
* in other clinical trials within 30 days
* addicted in drugs or alcohol, AIDS patients
* uncontrollable seizure or psychotic patients without self-control ability
* severe allergy or idiosyncrasy
* not suitable for this study judged by researchers
Comparison Between Respiratory Therapy With Cough Assist Technique and Usual Respiratory Therapy in Intensive Care Patients Suffering of Neurologic Disorder

The present study aims to compare the efficiency of respiratory therapy with cough assist and the efficiency of usual respiratory therapy in intensive care patients suffering of neurologic disorder and cough ineffectiveness. The investigators hypothesis is that cough assist is more efficient than usual respiratory care in this group of patients.


Eligibility Criteria:
Inclusion Criteria:

* Peak flow \< 270 ml if the patient has one of the following diagnostic: post neurosurgery status, cerebral trauma, tetraparesia or tetraplegia

Exclusion Criteria:

* Death expected in the following 24h
* Bulbar dysfunction if extubated
* pneumothorax
* intracerebral mass effect
* elevated intracranial pressure
Bioavailability of SC Formulation and Japanese Ethnobridging Study for PRA023

This is a randomized double-blind, placebo-controlled, single-dose study to evaluate the safety, tolerability, and pharmacokinetics of PRA023 in healthy Caucasian and Japanese adult volunteers


Eligibility Criteria:
Inclusion Criteria:

* Subjects are required to meet the following criteria in order to be included in the study:

  1. Japanese subjects must have both natural (not adopted) parents and four grandparents of Japanese origin.
  2. Caucasian subjects must be of European or Latin American descent (i.e., White).
  3. Male or female (of non-childbearing potential only) between minimum adult legal age (according to local laws for signing the informed consent document) and 55 years of age.
  4. Females must be of non-childbearing potential and must have undergone one of the following sterilization procedures, and have official documentation, at least 6 months prior to the first dose:

     1. hysteroscopic sterilization;
     2. bilateral tubal ligation or bilateral salpingectomy;
     3. hysterectomy;
     4. bilateral oophorectomy, or;
     5. be postmenopausal with amenorrhea for at least 1 year prior to the first dose and have FSH serum levels consistent with postmenopausal status as per Investigator judgment.
  5. Male subjects must use reliable forms of contraception during sexual intercourse with female partners from screening to 30 days after the end of dosing.
  6. Good general health as determined by medical history, and by results of physical examination, chest x-ray, vital signs, ECG, and clinical laboratory tests obtained within 28 days (4 weeks) prior to study drug administration.

Exclusion Criteria:

* Subjects with the following characteristics will be excluded from the study:

  1. History or presence of any clinically significant organ system disease that could interfere with the objectives of the study or the safety of the subjects.
  2. Blood pressure and heart rate are outside the ranges 90-140 mmHg systolic, 60-90mmHg diastolic, heart rate 60-100 beats/min.
  3. 12-lead ECG with any abnormality judged by the Investigator to be clinically significant, QRS \>= 120 milliseconds (msec), or QTcF interval of \> 450 msec for men or \> 470msec for women.
  4. Presence or history of any abnormality or illness, which in the opinion of the Investigator may affect absorption, distribution, metabolism or elimination of the study drug.
  5. Any screening laboratory evaluation outside the laboratory reference range that is judged by the Investigator to be clinically significant.
  6. History of or current active tuberculosis (TB) infection; history of latent TB that has not been fully treated or current latent TB infection as indicated by a positive QuantiFERON-TB test.
  7. History of significant allergy to any medication as judged by the Investigator.
  8. History of alcohol or drug abuse within the past 24 months.
Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy With Prior Spontaneous Preterm Birth

Preterm birth (PTB) is the major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors. Few prognostic tests are available to predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to be a good predictor of PTB.Different strategies have been adopted for prevention of PTB. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix, while cervical cerclage seems to be beneficial only in the subgroup of singleton gestations with both prior spontaneous PTB and TVU CL ≤25mm, and not in singletons without prior PTB, nor in multiple gestations.

However, so far there are no level-1 data on the efficacy of TVU CL screening neither in low risk nor in high risk pregnancy Thus, the investigators aim to assess the efficacy of a policy of TVU CL screening in singleton pregnancy with prior spontaneous PTB


Eligibility Criteria:
Inclusion Criteria:

* 18-50 years of age
* Singleton gestations
* Women with prior spontaneous preterm birth, defined as spontaneous preterm delivery 16 0/7 - 36 6/7 weeks

Exclusion Criteria:

* multiple gestation
* Ruptured membranes or fetal structural or chromosomal abnormality at the time of randomization
* Ballooning of membranes outside the cervix into the vagina at the time of randomization
* Labor or cerclage in situ at the time of randomization
Comparison Of Dexmedetomidine and Fentanyl In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy.

Compare effects of intravenous dexmedetomidine and fentanyl in attenuation of intubation response in a patient undergoing laparoscopic cholecystectomy.

Compare the effects of intravenous dexmedetomidine and fentanyl in sedation, perioperative complications, and recovery in these patients.

Dexmedetomidine is comparatively a newer drug in countries like Pakistan. There is no research work available at the national level and scarcity of data at an international level with inconclusive outcomes. Our participation in the form of this research will add to scientific literature and step up ahead at the international level.

Fentanyl citrate is a narcotic analgesic interacting predominantly with the opioid μ receptor and exerting its principal pharmacological effect on CNS. Its primary action of therapeutic value is analgesia and sedation. It is extensively used for anesthetic and analgesic most often in operating room and ICU.

This is double-blind, a single centered randomized clinical trial which is based on assessing the hemodynamic stability provided by our study drugs during laryngoscopy and intubation in a patient undergoing laparoscopic cholecystectomy. In addition to that this study will assess the perioperative complication and postoperative recovery in these patients. Laparoscopy has now become the standard technique of choice for cholecystectomy which results in pathophysiological changes characterized by an increase in arterial pressure and heart rate (HR). Many types of research have been done in an attempt to minimize adverse effects by adding adjuvants to the conventional method of general anesthesia. Our research is also based on this aim. The objective of this study to determine the hemodynamic stability during laryngoscopy and intubation, peri-operative complication and post-operative recovery. The patients will be divided into two groups randomly and will be given the desired drugs via intravenous line by on floor consultant anesthetist who will be blinded to the drug. The study subjects' hemodynamics will be observed until 10 minutes of intubation. Any perioperative complication will be noted. The subjects will also be followed postoperatively in recovery to check there sedation score and recovery (Aldrete score) will be noted after 10 minutes after the patient shifted to recovery.

Eligibility Criteria:
Inclusion Criteria:

1. ASA-I and ll patients
2. Male and female patient of age 20-70 years.
3. Undergoing Elective laparoscopic cholecystectomy.

Exclusion Criteria:

1. Pregnant and lactating females
2. Short thick neck with anticipated difficult intubation.
3. Obese patients.
4. Narcotic addicts.
5. Full stomach patient or with higher chances of aspiration.
6. Patient allergic to any of the study medications.
7. Patients high risk to develop serotonin syndrome. (patient taking an antidepressant and other psychomotor medications.
Natural History Study in Pediatric Patients with STXBP1 Encephalopathy with Epilepsy

This is a prospective, non-interventional, longitudinal study designed to characterize the natural history of STXBP1 related encephalopathy with epilepsy, in participants ≤ \<5 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, \> 1 day to ≤ 5 years of age at the time of informed consent.
* Diagnosed with seizure disorder
* Presence of a STXBP1 gene mutation. Historical documentation is sufficient to support eligibility for the study. Confirmatory testing will be obtained at baseline and performed by a CLIA certified laboratory
* Written informed consent provided by a parent or legal guardian

Exclusion Criteria:

* History of prior gene therapy treatment
* Current enrollment in an interventional study or has received an investigational drug within 30 days or fewer than 5 half-lives prior to screening visit, whichever is longer
* Treatment with any antisense oligonucleotide therapy within 6 months prior to screening and anticipate remaining on treatment throughout the study
* The presence of a confirmed mutation in a gene other than STXPB1 that is known to contribute to a neurodevelopmental disability
* Presence of a significant non-STXBP1 related central nervous impairment/behavioral disturbance that would confound the scientific rigor or interpretation of results of the study
* History of prematurity (defined as gestational age \<35 weeks), interventricular hemorrhage, structural brain deficit or congenital heart disease
* Requires mechanical ventilation or non-invasive respiratory support such as continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) at the time of informed consent
Adequate Bending Angle of a Lightwand

For tracheal intubation with a lightwand, adequate bending angle was not exactly investigated. The purpose of the study is compare three bending angles of lightwands for safe and efficient tracheal intubation.

Lightwands are very useful device for difficult airway management due to small moth opening, weak teeth, and cervical spine instability. Experienced clinicians use a lightwand while bending it adequately. However, there has been not previous studies to investigate the adequate angle to bend it.

This randomized controlled trial is to compare three angles (70, 80, and 90 degrees) as bending angle of lightwands for safe and efficient tracheal intubation in cases which require the use of lightwands.

Eligibility Criteria:
Inclusion Criteria:

* patients who require use of a lightwand for tracheal tubes (i.e. small mouth opening, weak teeth, cervical spine instability)

Exclusion Criteria:

* patients who refuse to participate the study
PD-HF: A Trial of Peritoneal Dialysis in Patients With Severe Heart Failure and Chronic Kidney Disease

This trial is to establish whether ultrafiltration by peritoneal dialysis is a clinically effective treatment for patients with severe heart failure and moderate chronic kidney disease, thus improving quality of life and symptoms.

The trial is a multi-centre, prospective, randomised, unblended, controlled trial of intermittent PD with a single daily exchange of icodextrin plus best standard care versus best standard care for the treatment of severe HF and moderate CKD. A second exchange with glucose based solution may be given, should it be required in the investigator's/clinician's opinion. Investigators will randomise 130 participants for 32 weeks with randomisation stratified by participating centre. Participants will be recruited from specialist-led outpatient HF services in 6 NHS trusts and be managed by both cardiologists and nephrologists.

PD catheter insertion will occur according to the participating centre's institutional protocol. Treatment begins 1 week after catheter insertion and consists of a single nightly exchange.

Eligibility Criteria:
Inclusion Criteria:

* Severe heart failure (NYHA grade III or IV)
* Chronic kidney disease stage 3-4
* Fluid overload resistant to diuretics OR hospital admission for HF in last 6 months
* Left ventricular ejection fraction ≤40% in last 2 years (moderate/severe)
* Using optimal HF medication for ≥ 4 weeks including ACE-inhibitor (angiotensin-converting-enzyme inhibitor) OR angiotensin receptor blocker AND aldosterone antagonist AND beta-blocker unless intolerant and without dose change for ≥ 4 weeks
* Appropriately screened for revascularization and/or cardiac resynchronization therapy if clinically indicated.

Exclusion Criteria:

* Does not wish to participate
* Mental incapacity to consent
* CKD stage 5
* Normal renal excretory function
* Haemodynamically significant valvular disease amenable to surgery
* Cardiac or renal transplantation
* Considered by the investigator to unsuitable for PD due to previous abdominal surgeries, peritonitis, social circumstances or other reason
DEPLIPIDO Study: Functional and Lipidomic Analysis of Plasma HDL in Patients with Depression Compared to Controls

Depression is a disabling condition in terms of psychosocial alteration and also in terms of physical comorbidities. Depression doubles the risk of myocardial infarction compared with the general population, and this cardiovascular comorbidity leads to an increase in mortality in patients suffering from depression, even exceeding suicide-related mortality.

It is therefore important to better understand the mechanisms linking depression and cardiovascular disease.

Among the hypotheses that may account for the increased cardiovascular risk in patients with depression, lipid abnormalities are likely to play a crucial role.

Thus, qualitative and functional abnormalities in HDL lipoproteins are an important line of research, insofar as these lipid abnormalities have been recognized as important atherogenic abnormalities in populations at high cardiovascular risk, which is the case of patients with depression.

In this clinical, epidemiological and scientific context, a collaborative study undertaken by both the Department of Psychiatry of the Dijon Bourgogne University Hospital of and the INSERM LNC-UMR 1231 (PADYS) Laboratory of the UNIVERSITY OF BOURGOGNE FRANCHE-COMTE is an original translational research project, and the first study to perform a lipidomic analysis of HDL, coupled with a functional analysis of these lipoproteins in depression.


Eligibility Criteria:
Inclusion Criteria:

* FOR PATIENTS WITH RECURRENT DEPRESSION :

  * Patient who has provided oral consent
  * Adult with moderate to severe depression according to DSM-5 criteria (Hamilton HDRS-17 score ≥ 18), with a number of depressive episodes ≥ 3
* PATIENTS PRESENTING WITH A FIRST DEPRESSIVE EPISODE

  * Patient who has provided oral consent
  * Adult with moderate to severe characterized depression according to DSM-5 criteria (Hamilton HDRS-17 scale score ≥ 18) presenting with a first depressive episode.
* CONTROLS

  * Person who has provided oral consent
  * Adult who has never shown signs of depression

Exclusion Criteria:

* Person not affiliated with national health insurance
* Person subject to a measure of legal protection (curatorship, guardianship)
* Pregnant or breastfeeding women
* Adult unable to express consent
* Minors
* Person with a metabolic syndrome (according to NCEP/ATP-III criteria: 3 of the following 5 criteria: Waist circumference ≥ 102 cm in males and ≥ 88cm in females, Triglycerides \> 1.50 g/L, HDL-Cholesterol \< 0.40 g/L in H, HDL-Cholesterol \< 0.50 g/L in F, Blood pressure ≥130/85mmHg, Fasting blood glucose ≥ 1.10 g/L),
* Person with type 1 or type 2 diabetes,
* Person with a mild depressive episode (HDRS-17\<18),
* Person with concomitant antipsychotic treatment
* Person with bipolar disorder,
* Person with a moderate to severe alcohol use disorder according to DSM-5 criteria
* Person with schizophrenia,
* Person with a persistent delusional disorder,
* Person with an autism spectrum disorder.