cyrilzakka/clinical-trials huggingface dataset:
Comparing Validity of Non-Invasive Hemoglobin Monitoring to Laboratory Results in Critically Ill Children

This is a prospective study to determine the accuracy of the Masimo Pronto Non-Invasive Hemoglobin Monitor and associated Rainbow® probes in the detection of hemoglobin concentration in critically ill children.

This is a prospective study to determine the accuracy of the Masimo Pronto Non-Invasive Hemoglobin Monitor and associated Rainbow® probes in the detection of hemoglobin concentration in critically ill children. Data from at least 30 patients admitted to the Pediatric Intensive Care Unit (PICU) over a period of 2 months will be collected and analyzed for this study.

Note, that this device would not lead to deviations in routine patient care; specifically, the non-invasive monitor placed on the patient's finger is FDA approved. The proposed monitors are identical macroscopically to monitors, which are currently used to measure oxygen saturation at this institution. Clinical decisions, additional blood draws or alterations to the plan of care will not be made based on study data. The objective is to compare the validity of the hemoglobin values determined from non-invasive technology with measured laboratory values for hemoglobin utilized as standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Patient has been admitted to Pediatric Intensive Care Unit
* Patient age is ≥ 30 days old and ≤ 18 years old
* Patient weight ≥ 3 Kg.
* Patient requires hemoglobin monitoring

Exclusion Criteria:

* Patient does not have exposed fingers/toes,due to congenital anomalies wound dressing or injury.
* Patient weight is less than 3 Kg
* Patient is less than 30 days old
Enhancing the Lucentis (Ranibizumab) Management of Choroidal Neovascular Membranes With Hyperspectral Imaging

Clinical trial investigating the role of hyperspectral imaging in the management of patients undergoing standard clinical treatment for naive neovascular choroidal membranes in age-related macular degeneration.

Observational trial of patients with choroidal neovascular membranes treated with Lucentis. Exploration and validation of a new form of retinal imaging called hyperspectral imaging.

Inclusion: Patients meet eligibility criteria other than FFA diagnosis and who are diagnosed with suspected exudative CNV on the OCT. (n=100 eyes) Procedure: Monthly doses of Lucentis. OCT scans will be taken prior to each injection. HSI image taken at baseline and at the 9-month time point.

Time frame: 6 months recruitment + 12 months follow-up + 6 months analysis.

All recruited patients will receive monthly doses of Lucentis as per the CMBS-approved protocol to allow comparison with other published studies. Lucentis will be administered in accordance with published standards of practice.

OCT scans will be taken prior to each injection. HSI image will be taken at baseline, three months and 9-month time points

Eligibility Criteria:
Inclusion Criteria:

* Provide signed and dated informed consent form
* Willing to comply with all study procedures and be available for the duration of the study
* Male or female, aged 50-80
* In sufficiently good general health to be able to have a FFA
* CNV diagnosed by OCT
* Vision equal or better than 6/60 in the study eye
* No prior treatment in the study eye with anti-VEGF medication

Exclusion Criteria

* Significant media opacity.
* Known allergic reactions to components of the study product(s).
* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
AF Ablation Based on High Density Voltage Mapping and CFAE

The purpose of this study is to evaluate the efficacy of additional ablation targeting complex fractionated atrial electrogram area within low voltage zone identified by high resolution mapping in patients with persistent atrial fibrillation.

Fifty patients with persistent atrial fibrillation will be randomized a 1:1 ratio to each group. A test group includes those who undergoing ablation targeting low voltage areas which contains complex fractionated trial electrogram in addition to pulmonary vein isolation and a control group includes who undergoing pulmonary vein isolation only.

Eligibility Criteria:
Inclusion Criteria:

1. Age over 20 years old and under 80 years old
2. Patients with non-valvular atrial fibrillation
3. Patients having atrial fibrillation even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks
4. Patients who can understand the information sheet and consent form on the need and procedure of catheter ablation and submitted them
5. Patients who are available of follow-up at least for more than three months after catheter ablation

Exclusion Criteria:

1. Patients unsuitable for catheter ablation because the size of left atrium is over 6.0 cm
2. Patients unsuitable for catheter ablation due to previous history of pulmonary surgery or structural heat disease.
3. Patients who cannot receive standard treatments such as anticoagulation therapy which need to be continuously performed prior to radiofrequency catheter ablation
4. Patients in the subject group vulnerable to clinical study
5. Patients who had undergone a prior catheter ablation for atrial fibrillation
Effect of Tourniquet Binding of Cervical on the Blood Volume of Amniotic Fluid in Cesarean Section

This study was conducted to investigate whether the use of tourniquet after delivery of the fetus could reduce the amount of amniotic fluid entering the bloodstream and thus reduce the incidence of intraoperative adverse events.

Amniotic fluid embolism (AFE) is a rare complication specially to obstetrics.When amniotic fluid enters the maternal circulation , a sudden onset of a series of pathophysiologic changes such as pulmonary hypertension, hypoxemia, circulatory failure, disseminated intravascular coagulation, and multiorgan failure may occur. Routinely, the typical AFE triad is uneasy to discover, and nonspecific adverse reactions such as irritability, chills, chest tightness and shortness of breath, transient drop in blood pressure, and nausea and vomiting are often seen during delivery of the fetus and placenta. All of the above symptoms may suggest that the amniotic fluid has entered into the bloodstream. In clinical anesthesia, investigators observed that women with placenta praevia and placenta implantation were less likely to suffer these nonspecific symptoms after delivery of the fetus compared with women with normal pregnancies.The investigators speculated it might be related to the fact that obstetricians used tourniquets to reduce intraoperative hemorrhage in the former, blocking venous return to the lower uterine segments to reduce the inflow of amniotic fluid into the uterus. Therefore, this study was conducted to investigate whether the use of tourniquet after delivery of the fetus could reduce the amount of amniotic fluid entering the bloodstream and thus reduce the incidence of intraoperative adverse events.

Eligibility Criteria:
Inclusion criteria

1. Single pregnancy
2. Be in good health, with no high blood pressure or heart disease during pregnancy
3. Without placenta previa and placenta implantation
4. No abdominal adhesions, suitable for operation
5. Signed informed consent by the pregnant woman and her family

Exclusion criteria

1. Serious coagulation abnormality
2. Preoperative severe cardiac, cerebral, pulmonary, hepatic, renal and other important organs insufficiency and electrolyte abnormality combined with placenta praevia or placenta implantation
3. Multiple pregnancies
4. Previous history of abdominal surgery
5. Intraoperative drug allergy
GlitazOne Treatment for Coronavirus HypoxiA, a Safety and Tolerability Open Label With Matching Cohort Pilot Study

Pioglitazone is an approved anti-hyperglycemic medication and is thought to have anti-inflammatory properties. This study seeks to gather safety and tolerability data related to pioglitazone when given to patients who require hospital admission for confirmed positive COVID-19 infections with elevated blood sugar levels as compared to patients who did not receive pioglitazone during their hospitalization for COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Laboratory confirmed COVID-19 requiring hospitalization
* A1c greater than 5.6% as measured in the last 30 days
* Women of child-bearing potential who agree to use highly effective method of contraception (defined as either abstinence, condom, diaphragm, and/or oral or injected hormonal contraception) during dosing and for 30 days after last dose
* MRSA PCR screen negative

Exclusion Criteria:

* Pregnancy or nursing
* Congestive Heart Failure all classes (NYHA Class I, II, III or IV)
* Liver enzyme ALT greater than 2.5 times upper limit of normal
* End stage renal disease
* Hypersensitivity or allergy to a TZD (thiazolidinedione)
* Active bladder cancer
* Currently taking a beta blocker, a CYP2C8 inhibitor or inducer such as gemfibrozil or rifampin, a TZD
* Other current or historical illness that in the opinion of the investigator at attending provider would interfere with the subject's ability to complete the study or make it not in the best interest of the subject to participate
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-M23, a CAR-T Cell Therapy Targeting MSLN in Patients With Relapsed and Refractory Epithelial Ovarian Cancer

This study is a prospective, single-arm, open-label, single-dose dose finding and extension study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the LCAR-M23 CAR-T cell therapy in subjects with relapsed and refractory epithelial ovarian cancer after prior adequate standard of care.


Eligibility Criteria:
Inclusion Criteria:

1. The subjects have been fully informed of the possible risks and benefits of participating in this study and have voluntarily signed the informed consent form (ICF)
2. Age: 18-70 years (including 18 and 70 years)
3. Female subjects with histologically or cytologically confirmed advanced epithelial ovarian cancer including fallopian tube and primary peritoneal cancers
4. Mesothelin (MSLN) positive
5. Prior adequate standard of care, treatment failure or intolerance.
6. Imaging shows an evaluable tumor lesion
7. ECOG 0-1
8. Expected survival ≥ 3 months

Exclusion Criteria:

1. Patients who have received the following anti-tumor treatments prior to apheresis:

   * Cytotoxic therapy within 14 days
   * Small molecule targeted therapy within 14 days or at least 5 half-lives, whichever is shorter
   * Therapy with monoclonal antibody within 21 days
   * Immunomodulatory therapy within 7 days
   * Radiotherapy within 14 days and endocrine therapy within 14 days (including tamoxifen, aromatase inhibitor, high-potency progesterone and gonadotropin-releasing hormone analogue, etc.)
2. Previously treated with CAR-T/TCR-T cell therapy against any target or other cell therapies or therapeutic tumor vaccine
3. Previously treated with any MSLN-targeted therapy
4. Brain metastases with central nervous system symptoms
5. Pregnant or lactating women
6. Any condition in which, in the opinion of the investigator, the subject is ineligible for participation in the study
Triggers And Risk Factors to Develop a Reversible Cerebral Vasoconstriction Syndrome

This study will be the first to evaluate the role played by potential precipitating factors and risk factors in Reversible Cerebral Vasoconstriction Syndrome (RCVS) through of prospective selection of carefully characterised patients and controls. The impact of these factors on the prognosis will be evaluated through a follow-up assessment of patients.

Our study will include the formation of a clinicoradiological database and a biobank (plasma, cerebro-spinal fluid, DNA) which will be the tools of a future large multicentre study on RCVS.

Introduction : Reversible Cerebral Vasoconstriction Syndrome (RCVS) combines headaches and segmental constriction of cerebral arteries that resolves within 3 months.

It is the most recurrent reason of cerebral arteriopathy in people under 70 and of thunderclap headache in absence of aneurysmal subarachnoid haemorrhage.

Objectives :

* Principal: identify RCVS's precipitating factors
* Secondary:

  1. Determine if migraine, anxiety, depression are risk factors of RCVS.
  2. Determine the role of precipitating factors and risk factors on the RCVS's prognosis in short, medium and long term.
  3. Start a formation of a large clinicoradiological database and a biobank (plasma, cerebro-spinal fluid, DNA).

Methodology :

Monocentric analytic observational 'Case - Control' study with prospective inclusion of cases in a follow-up cohort.

This type of study is nevertheless considered interventional because we are collecting additional blood and CSF samples to constitute a biobank.

Eligibility Criteria:
Inclusion criteria:

* For the Patients

  * Men and women of 18 and more years old
  * Taken care in the CHU of Montpellier
  * Diagnosis of SVCR or SVCR without visible vasoconstriction makes in 14 days preceding the inclusion
  * According to the consensual criteria of diagnosis and those of the international classification of the headaches ICHD-3
  * Informed consent and writes for the participation in the study
* For volunteers

  * Men and women of 18 and more, mated in the Cases on the sex and the age
  * Patients with an acute pathology not Neurological and not vascular (for example, eye foreign body) OR Healthy Subjects
  * Informed written consent and for the participation in the study

Exclusion criteria:

* Coma, insanity, language barrier or severe aphasia preventing from answering the questions
* Follow-up considered impossible for 3 months (e.g.: priority associated pathology in the care, the transfer(transformation))
* People placed under legal protection
* Refusal to participate in the study
The Effect of Breastfeeding Counseling Based on Motivational Interviewing

This research was planned to determine the effect of breastfeeding counseling based on motivational interviewing method and standard breastfeeding counseling on breastfeeding self-efficacy and breastfeeding results in women who had a cesarean section.

This study was conducted between September 2023 and August 2024 as a single-blind randomized controlled study to determine the effect of breastfeeding counseling based on the motivational interview method and standard breastfeeding counseling on breastfeeding self-efficacy and breastfeeding results in women who had a cesarean section in Turkey. Participants who met the inclusion criteria were informed about the subject. The purpose of the study was explained to participants, and informed consent was obtained from all individuals who received motivational interviewing-based training or standard breastfeeding training. Data; When the research was approved, it was collected before the first counseling, in the first 48 hours after birth, and on the 14th day, 1st month and 3rd month after birth. CONSORT directive was followed in research planning

Eligibility Criteria:
Inclusion Criteria:

* • Between September 2023 and August 2024

  * Living in Turkey
  * Seeing the poster about the research on social media and applying for the research
  * Those between the ages of 18-40,
  * Native speaker of Turkish,
  * 34-40 weeks of pregnancy. between weeks,
  * First pregnancy,
  * Having a singleton pregnancy,
  * Determining the type of birth as planned cesarean section,
  * Do not have any chronic disease or pregnancy complications,
  * There is no obstacle to breastfeeding,
  * Does not have any psychiatric disease,
  * Not receiving any individual, special training or counseling other than standard training and counseling regarding breastfeeding during pregnancy,
  * Women who are ambivalent about breastfeeding

Exclusion Criteria:

* • Not attending at least one of the counseling sessions to be held,

  * Under 34 weeks and over 40 weeks,
  * Participating in another training or receiving counseling regarding breastfeeding,
  * Those who have health problems during the education process,
  * Mother or baby has a health problem that will affect breastfeeding processes in the postpartum period,
  * Those who have situations that may interrupt breastfeeding (hospitalization, medication use, separation from the baby, etc.),
  * Leaving messages unanswered during the research process, not answering phone calls at least 5 times a week, and not returning to the researcher,
  * Women who developed a psychological condition or psychiatric disorder during the research process
A Retrospective Study of Newly-diagnosed PCNSL Treated With a Methotrexate (MTX) and Orelabrutinib-based Regimen

This study was a single-centre, retrospective study that retrospectively collected first-line PCNSL patients receiving methotrexate-based chemotherapy ± orelabrutinib at Huashan Hospital of Fudan University. The study was divided into two retrospective cohorts, Cohort A was a cohort of patients receiving methotrexate-based chemotherapy alone, and Cohort B was a cohort of patients receiving methotrexate-based chemotherapy + orelabrutinib.

The study was divided into two retrospective cohorts of approximately 35-40 patients each. Cohort A was the cohort of patients who received methotrexate-based chemotherapy alone, and cohort B was the cohort of patients who received methotrexate-based chemotherapy + orelabrutinib. Statistical analyses such as propensity score analysis (PSM) and inverse probability weighted (IPTW) analysis were performed, focusing on comparing and analysing the short-term efficacy data (ORR, CR) and long-term efficacy data (PFS, OS) of the two cohorts.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed primary central nervous system lymphoma
* Methotrexate-based chemotherapy ± orelabrutinib regimen as first-line treatment for patients

Exclusion Criteria:

* Patients receiving ≤2 cycles of treatment without efficacy evaluation
* Those with uncontrolled or significant cardiovascular disease, including: uncontrolled diabetes mellitus, severe cardiac, pulmonary, hepatic, renal insufficiency) and haematological, endocrine system lesions, history of other uncontrollable malignancies
Impact of Home Monitoring to Decrease the Treatment Burden for Neovascular Age-related Macular Degeneration (AMD)

A study to use in home technology to reduce the burden of in office visits and injections.

Without frequent measurement of vision to monitor disease progression some people may be under-treated, while others over-treated. Under-treatment can lead to severe and irreversible disease progression and associated loss of vision. Over-treatment is expensive, uncomfortable and potentially increases the risk of complications. A self-monitoring device such as DigiSight can help subjects keep close control of their treatment, but alleviate the burden of in office monitoring visits. A decreased number of office visits in combination with the home self-monitoring may provide an effective alternative dosing regimen, allowing the physician and subject to closely track the disease progression and treatment effect without the demands of monthly or frequent visits to the office.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 50 years
* Choroidal neovascular membrane (CNV) secondary to AMD, as confirmed by the patient's medical history and a documented diagnosis of CNV
* The study eye must have received at least 3 anti-Vascular endothelial growth factor (VEGF) treatments prior to the screening visit, with at least 2 anti-VEGF treatments over the preceding 3 months.
* Best-corrected visual acuity (BCVA) of 20/32 to 20/200 Snellen equivalent in the study eye
* Noted presence of intra- or sub-retinal fluid on OCT in the study eye
* Adequate pupillary dilation to permit thorough ocular examination and testing in both eyes
* Proficiency in using the DigiSight SightBook™ mobile vision assessment tool on study-supplied Apple iPad or iPod device

Exclusion Criteria:

* CNV in the study eye due to any reason other than AMD
* Active uncontrolled glaucoma
* Had any intraocular surgeries in the study eye within 3 months of enrollment or are known or likely candidates for intraocular surgery (including cataract surgery) in the study eye within 1 year of enrollment
* Acute or chronic ocular or periocular infection in the study eye, uveitis or ocular inflammation in the study eye
* Received Photo Dynamic Therapy (PDT) in the study eye within 60 days, or laser photocoagulation within 14 days prior to screening
* Currently using any periocular or intravitreal steroids within 3 months prior to screening (study eye)
* Unstable or severe cardiovascular disease, e.g., congestive heart failure (New York Heart Association Functional class III/IV), myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina, or critical limb ischemia
* Poorly controlled diabetes
* Cerebrovascular disease within 12 months prior to Screening
* Dementia or neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease)
* Received any investigational product within 30 days prior to Screening
* Inability to properly use the SightBook™ app
Post-Concussion Aerobic Exercise

This study is looking at the specific role of an exercise prescription on recovery from concussion symptoms in the general population.

435 people will participate in this study.

A physician will review a participant's medical history to determine if physical activity is appropriate for them. They will then be randomly assigned to 1 of 3 study groups:

1. Monitoring- participants will be given a heart rate monitor to wear on their wrist for the duration of the study (until "recovered", or until 8 weeks post-concussion, whatever comes first).
2. Monitoring + Treadmill Testing- in addition to wearing the heart rate monitor, they will undergo a treadmill test at each appointment.
3. Monitoring + Treadmill Testing + Specific Exercise Prescription- in addition to wearing the heart rate monitor, and treadmill test, they will receive an exercise prescription based on the results of the treadmill test.

The randomization is by chance. Participants have a 40/20/40% respective chance of being assigned to the study groups above. This means that out of every 5 people: 2 people will be assigned to the group 1, 1 will be assigned to the group 2, and 2 will be assigned to the group 3. Both participants and the study doctor will be aware which group participants are in.

Regardless of the group assigned, participants will receive an exercise prescription form at each appointment, as per usual care. The prescription will be based on the physician's judgement. If a participant is in group 3, their prescription will also take into account the results of the treadmill test.

Recovery will be determined using a 3-step approach:

1. Self-reported symptoms,
2. Clinic physician's opinion,
3. Treadmill test results (if applicable).

Eligibility Criteria:
Inclusion Criteria:

* Patients that provide written informed consent prior to entry into the study
* Patients referred from the emergency department (ED) with recent (\<1 week) diagnosis of concussion by ED physician
* GCS score of 13-15 on presentation to the ED
* SCAT score \> 9 at week 1
* Physician cleared for exercise; low risk for cardiac disease (defined as no cardiopulmonary symptoms and meet no more than one risk factor for heart disease)
* Willing to exercise

Exclusion Criteria:

* Evidence of intracranial hemorrhage, contusion or injury on brain imaging (CT Scan)
* Beta-blocker medication
* High dose (\>50mg/day) tricyclic antidepressant medication
* Pre-existing or current orthopedic injuries preventing exercise
* Pre-existing vestibular disease preventing exercise
* Heartrate increase \<30 bpm from rest on treadmill test
* Deemed asymptomatic from concussion by clinic physician
* Unable/unwilling to follow commands