cyrilzakka/clinical-trials huggingface dataset:
The Feasibility of PetCO2 Prediction Hypotension Under Spinal Anesthesia for Cesarean Section

Maternal hypotension is a common side effect after spinal anesthesia for cesarean delivery.Decreased vascular resistance and cardiac output, due to sympathetic blockade1and blood pooling in blocked areas of the body respectively, are main causes of spinal anaesthesia-induced hypotension during Caesarean delivery.

Cardiac output, which has shown to be a better predictor of organ and placental perfusion than arterial blood pressure.Few studies have measured CO after spinal anesthesia in the maternal population.This is largely because of the lack of availability of accurate and reproducible noninvasive measurement techniques. Up to now, preventing hypotension has continued to focus on arterial blood pressure variables, fluid, and ephedrine requirements as markers of cardiovascular status, because these are more easily measured.

Investgators hypothesized that CO and PetCO2, in parturients with the degree of hypotension during spinal anaesthesia, would also have a positive and significant association.


Eligibility Criteria:
Inclusion Criteria:

* full-term gestation (\>36 and \<41 weeks of gestation) with a singleton pregnancy

Exclusion Criteria:

* emergency cases
* placenta praevia
* preeclampsia
* cardiovascular or cerebrovascular disease
* morbid obesity with a BMI≥40
* contraindications to spinal anaesthesia
The Side of Implantable Central Vascular Catheters and Complications

Whether the side of implantable CVCs was associated with the complication rates remains unclear. The investigators plan this study to explore this issue by randomizing patients to receive CVC implantation at the left subclavian or righ subclavian vein.

Implantable central venous catheters (CVC) are crucial for cancer patients. They provide central venous access for chemotherapy and high-concentration nutrition support. However, several potential CVC-related complications may develop and severely interfere with the patients' cancer treatment and can be life-threatening in some occasions.

Thrombotic events occurred in around 20% of cancer patients with implantable CVCs. Such events included intraluminal thrombosis and catheter-related venous thrombosis. Catheter removal was usually necessary to resolve these conditions. Treatment delays are inevitable for these patients. Besides, these thrombotic complications were associated with catheter-related infection, which could be highly dangerous for cancer patients.

Risk factors associated with these thrombotic events included the hypercoagulable state of the patients, the cancer types, the catheter types, and the placement of the catheter tips in the superior vena cava. Some single-arm studies found that CVC inserted from the left subclavian veins led to more CVC-related thrombosis than those inserted from the right subclavian vein. However, for most right-handed patients, to place these implantable CVCs on the right side is inconvenient for daily life because vigorous exercise was then impossible. Besides, these single-arm studies could not well control the other potentially interfering factors, such as the operators, catheter location and cancer types.

Therefore, we plan a randomized observational study to explore whether the side of implantable CVCs was actually associated with the complication rates. Cancer patients who need implantable CVCs will be randomized to have the catheters implanted either in the left subclavian vein or the right subclavian. Patients who had breast cancer, mediastinal mass with the diameter \> 6 cm, ECOG performance score \>2, or those who were not able to receive a standing P-A view chest X-ray will be excluded. Patients who had other reasons that prevented the randomization will also be excluded. The catheter-related complications will be actively reported by the patients. We will also enforce the records of complications by chart reviews and regular telephone contacts.

With the study, we can demonstrate whether a left-sided CVC and a right-sided CVC are different in complication rates. The result should be very useful in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Cancer patients who required implantable CVCs
2. Age \> 20
3. Not previously implanted with implantable CVCs in subclavian veins.

Exclusion Criteria:

1. Breast cancer patients
2. Mediastinal mass \> 6 cm
3. ECOG performance score \> 2
4. Not able to receive a standing P-A view chest X-ray exam.
5. One of the subclavian veins has problems preventing randomization
Evaluation of the Analgesia by Serratus Plane Block During Pleural Drainage in Intensive Care Unit.

Pleural drainage under local anesthesia is a frequent practice in resuscitation, experienced as an unpleasant and painful event for patients. Pain management is an important issue for early rehabilitation, decrease hospitalisation's cost and shortening the length of stay in intensive care unit (ICU). A new type of locoregional anesthesia called Serratus plane block described by Blanco in 2013 showed a benefit in per and postoperative analgesia in thoracic surgery and carcinologic breast surgery, allowing a decrease in morphine use and an improvement of the patient's general satisfaction. Serratus plane block is a very effective technique in chest wall analgesia, easy and safe to perform, with few complications. No studies to date have evaluated this anesthetic practice in intensive care for pleural drainage. This technique could be used outside the operating room to improve the intensive care patients, who often have heavier pathologies and greater pain, such as patients with chest trauma or patients with cardiac or respiratory disease. The investigators would like to conduct a preliminary study of superiority in the CHU Amiens intensive care unit, to study the interest of the Serratus plane block in comparison with local anesthesia on the management of acute pain during pleural drainage.


Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years old.
* non-intubated patient with spontaneous ventilation
* free and informed consent of the patient,
* affiliated to a social security scheme
* hospitalized in ICU unit including surgical ICU, cardiothoracic and respiratory ICU or cardiothoracic and respiratory continuous care unit.
* requiring pleural drainage gas or fluid
* conscious patient, not sedated.

Exclusion Criteria:

* patient under the age of 18 years old.
* patient refusal
* under curatorship or deprivation of liberty
* pregnant, parturient or breastfeeding woman
* contraindication to Lidocaine or Ropivacaine
* coagulation disorders
Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome

This study will assess the potential impact of elagolix on disordered pituitary and ovarian hormones in women with polycystic ovary syndrome (PCOS).

This is a phase 2, multicenter, double-blind (sponsor-unblinded), randomized, placebo-controlled study to assess the safety and efficacy of elagolix in women with PCOS. PCOS is one of the most common hormonal disorders in women of reproductive age, yet few treatment options are available. This study will help determine if elagolix can impact disordered hormonal dynamics in women with PCOS and at what dosage.

Eligibility Criteria:
Inclusion Criteria:

* Participants with clinical diagnosis of PCOS.
* Participants with a body mass index (BMI) of 18.5 to 38 kg/m\^2 at time of Screening.

Exclusion Criteria:

* Participants with newly diagnosed medical condition requiring intervention that has not been stabilized at least 30 days prior to Baseline.
* Participants with a significant medical condition that require intervention during the course of study participation (such as anticipated major elective surgery).
* Participants with an unstable medical condition (including, but not limited to, uncontrolled hypertension, epilepsy requiring anti-epileptic medicine, unstable angina, confirmed inflammatory bowel disease, hyperprolactinemia, clinically significant infection or injury).
Ketamine Sedation As Neuroprotective Agent Following Out-of-hospital Cardiac Arrest

OHCA is a critical medical emergency with significant mortality and morbidity primarily due to hypoxic-ischemic brain injury (HIBI). Despite advances in resuscitation techniques, the neurological outcomes for survivors remain poor. Current post-resuscitation practices lack specific neuroprotective strategies. Ketamine, an N-Methyl-D-Aspartate (NMDA) receptor antagonist, has shown potential neuroprotective properties in preclinical and clinical studies due to its ability to inhibit excitotoxicity and reduce neuronal apoptosis. This trial hypothesizes that ketamine, when used for sedation in OHCA patients, may offer superior neuroprotective benefits compared to the commonly used sedative propofol. By comparing the effects of ketamine and propofol on neuronal damage markers and long-term neurological outcomes, this study aims to identify a potentially effective intervention to improve the prognosis of OHCA patients.


Eligibility Criteria:
Inclusion Criteria:

* Adults (age ≥18 years) AND
* resuscitated OHCA of presumed cardiac cause with a shockable first recorded heart rhythm AND
* mean arterial pressure (MAP) \>40 mmHg AND
* a decision to perform prehospital intubation.

Exclusion Criteria:

* Advanced life support termination-of-resuscitation (TOR) criteria met
* Systolic blood pressure \>190 mmHg
* Known allergy to ketamine or propofol
* Chronic diseases making 180-day survival unlikely
* Body temperature \<30° C.
Evaluation of the Addictive Potential of E-Cigarettes

This study will examine the subject matter from a neurobiological and a neuropsychological vantage point to ascertain whether the e-cigarette is potentially as addictive as the traditional tobacco cigarette.

This project aims to examine the addictive potential of e-cigarettes through three different lenses, combining neurobiological, sociological and epidemiological research methods and levels of observation. The neurobiological perspective will investigate the rewarding effects of vaping, using neurobiological and neuropsychological measurements on e-cigarette users, as compared to nicotine-naïve participants.

The researchers will use established fMRI paradigms to measure the reward potential of e-cigarettes: First, craving will be investigated in an experimental approach by presenting conditioned stimuli to participants; and second, motivation for e-cigarettes compared to combustible cigarettes or money will be measured in an experimental work task. In addition, a dot-probe-task will be used in combination with eye-tracking to measure the attentional bias for e-cigarette stimuli. As part of the neuropsychological assessment outside the fMRI, the approach bias for smoking cues will also be investigated. The aim is to examine whether chronic use of e-cigarettes leads to similar conditioning processes and comparable aspects of motivation as that of traditional tobacco cigarettes.

The investigators will examine the punishment potential of e-cigarettes in a secondary research question, using questionnaires on withdrawal and on the consequences of smoking, both for traditional tobacco and for e-cigarettes.

The results of this project are relevant for the development of preventive healthcare and new treatment options. The neurobiological approach will also provide implications for individualized therapy by identifying consumer groups with different neuronal patterns.

Eligibility Criteria:
Inclusion Criteria:

* E-cigarette consumers: daily e-cigarette use (additional smoking of classic tobacco cigarettes is not an exclusion criterion)
* Nicotine Naïve: lifetime consumption of less than 20 cigarettes or e-cigarettes.
* normal or correctable eyesight
* sufficient ability to communicate with investigators and answer questions in both written and verbal format
* ability to provide fully informed consent and to use self-rating scales

Exclusion Criteria:

* common exclusion criteria for MRI (e.g. metal, claustrophobia, pregnancy)
* severe internal, neurological, and/or psychiatric comorbidities
* other Axis I mental disorders other than TUD or specific phobias within the last 12 months
* psychotropic medication within the last 14 days
* positive drug screening (opioids, benzodiazepines, barbiturates, cocaine, amphetamines)
* positive pregnancy test

The inclusion and exclusion criteria are checked in advance in a telephone screening. Smokers are asked not to smoke for eight hours before the examination.
A Double-Blind Study to Evaluate the Efficacy and Safety of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome)

This Phase 3 study will evaluate the efficacy and safety of 2.0 mg/kg/week BMN 110 and 2.0 mg/kg/every other week BMN 110 in patients with mucopolysaccharidosis IVA (Morquio A Syndrome).

There is currently no standard accepted treatment for MPS IVA other than supportive care. Enzyme replacement therapy (ERT) may be a potential new treatment option for MPS IVA patients. BMN 110 is administered to MPS IVA patients by IV infusion, allowing cellular uptake by the mannose-6-phosphate receptor and transportation to the lysosomes.

This enzyme uptake into the lysosomes is hypothesized to promote increased catabolism of keratan sulfate (KS) in tissue macrophages, hyaline cartilage, other connective tissues, and heart valve, and reduce the progressive accumulation of KS which is responsible for the clinical manifestations of the disorders.


Eligibility Criteria:
Inclusion Criteria:

* At least 5 years of age.
* Documented clinical diagnosis of MPS IVA based on clinical signs and symptoms of MPS IVA and documented reduced fibroblast or leukocyte GALNS enzyme activity or genetic testing confirming diagnosis of MPS IVA.
* Willing and able to provide written, signed informed consent, or in the case of patients under the age of 18 (or 16 years, depending on the region), provide written assent (if required) and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures.
* Must meet the study entrance requirements for the 6-minute walk test.
* Sexually active patients must be willing to use an acceptable method of contraception while participating in the study.
* Females of childbearing potential must have a negative pregnancy test at Screening and be willing to have additional pregnancy tests during the study.

Exclusion Criteria:

* Previous hematopoietic stem cell transplant (HSCT).
* Previous treatment with BMN 110.
* Has known hypersensitivity to any of the components of BMN 110.
* Major surgery within 3 months prior to study entry or planned major surgery during the 24-week treatment period.
* Pregnant or breastfeeding at Screening or planning to become pregnant (self or partner) at any time during the study.
* Use of any investigational product or investigational medical device within 30 days prior to Screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.
* Concurrent disease or condition, including but not limited to symptomatic cervical spine instability, clinically significant spinal cord compression, or severe cardiac disease that would interfere with study participation or safety as determined by the Investigator.
* Any condition that, in the view of the Investigator, places the patient at high risk of poor treatment compliance or of not completing the study.
PROSENZA: Prospective Multi-Centre Study of Prognostic Factors in mCRPC Patients Treated With Enzalutamide.

PROSENZA is a prospective multicentre observational study in metastatic Castration-Resistant Prostate Cancer (mCRPC), designed to explore prognostic biomarkers in patients undergoing treatment with enzalutamide

This study is a prospective biomarker study of patients with mCRPC undergoing treatment with enzalutamide as standard of care treatment. The participants will undergo serial pre- and post-therapy blood collection for biomarker analysis as part of the primary objective of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Male age ≥ 18 years
2. Histologically confirmed adenocarcinoma of the prostate
3. ECOG Performance Status ≤ 2
4. Castration resistance must be documented with surgical or medical castration with serum testosterone \< 50 ng/mL (\< 2.0 nM).
5. Men diagnosed with at least one metastatic lesion on CT or bone scan.
6. Documented biochemical and/or radiographic progression to previous treatment according to PCWG2 criteria.
7. Patients who are candidates for standard of care treatment with enzalutamide 160 mg every 24 hours.
8. Availability of formalin-fixed paraffin-embedded blocks from the prostate biopsy and/or radical prostatectomy.
9. Acceptable hematological, hepatic and renal functions.

Exclusion Criteria:

1. Previous cancer diagnosis, except those patients who had a localized malignant tumour and who are five years cancer-free or those diagnosed with skin cancers (of non-melanoma type) or excised in situ carcinomas.
2. Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data
Stress Management Intervention in Early Stage Cancer: Randomized Controlled Trial

The purpose with this study is to test the effect of an app for stress management among patients with a variety of cancer diagnoses.

A cancer diagnosis and subsequent treatment can be disruptive and traumatic, often accompanied by a multitude of stressors for the patients and their support network. Uncertainty of outcome and invasive medical procedures with aversive side effects are not uncommon, and while people differ widely in how they experience and cope with such challenges, cancer related distress including anxiety, depression, worry and rumination is prevalent. With multiple domains of function impacted it is also not surprising that quality of life (QoL) often is diminished.

Stress management interventions can facilitate adjustment to cancer, including reduced distress and improved quality of life. Unfortunately, many people with cancer do not have the strength or opportunity to attend groups or in-person interventions.

This study will therefore test the effect of an app for stress management among patients with different cancer diagnosis. The app contains 10 modules distributed over five weeks, focusing on education of different techniques for reduction of stress and stress reduction exercises.

The app was tested in a feasibility pilot study among 25 patients with a variety of cancer diagnoses and is now being tested in a randomized controlled trial with a sample of 175 cancer survivors. The participants were randomly assigned to use the 10 module app or to a control group that receive treatment as usual, and will be followed with repeated measures over 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with cancer (all diagnosis).
* Maximum time since completed treatment at hospital: 12 months
* Patients are \> 18 years of age, able to write/read/speak Norwegian and have their own smart phone or tablet

Exclusion Criteria:

• None
Subjective Comfort With Multipurpose and Hydrogen Peroxide Lens Care Solutions in Soft Contact Lens Wearers

The purpose of this study was to assess comfort in soft contact lens wearers.


Eligibility Criteria:
Inclusion Criteria:

* Wear silicone hydrogel contact lenses on a daily wear basis;
* Currently using OPTI-FREE RepleniSH contact lens solution;
* Report comfort above 75 on a Visual Analog Scale at the Baseline Visit;
* Read, sign, and date IRB-approved informed consent and the privacy document;
* Be generally healthy and have normal ocular health;
* Be be willing to follow the study procedures and visit schedule;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Use of additional lens cleaners;
* Known sensitivity to any ingredient in either of the test articles;
* Systemic or ocular disease or disorder (except refractive error) that would negatively affect the conduct or outcome of the study;
* Prior (within 7 days of enrollment) or current ocular infections;
* Clinically significant lash or lid abnormality;
* History of ocular surgery/trauma within the last 6 months;
* Use of any topical ocular or systemic antibiotics or corticosteroids within 7 days of enrollment;
* Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment;
* Other protocol-defined exclusion criteria may apply.
Effects of Seaweeds Combined With Probiotics on Intestinal Function of Healthy Subjects

The aims of this study are to investigate the effect of seaweeds which is one of the main ingredients of Korean traditional food 'Kimchi' and probiotics on intestinal function of healthy subjects.

Kimchi is one of the the typical and main foods in Korea. Seaweed is one of the important ingredient of Kimchi and has been known to have antiinflammatory, anticoagulant and antiadhesive effects. As seaweeds are fermented in order to make Kimchi, it can encourage beneficial probiotics to grow and lead to preventing digestive problems such as constipation and diarrhea.

In this trial, we are going to investigate the effect of combination of seaweeds and probiotics on intestinal function of healthy subject by evaluating intestinal microbiota. The trial is a randomized, double-blinded, placebo-controlled, 2-arm study. Forty patients with normal intestinal condition will be randomly assigned to one of the 2 groups consisting of Seaweed with real probiotics or Seaweed with placebo probiotics. The assigned treatments will last for 4 weeks and the follow-up period will be 2 weeks.

Four weeks of administration of seaweeds and probiotics is expected to increase the amount of beneficial microbiota and reduce that of harmful microbiota in intestine. we will also use questionnaires such as K-GSRS (Korean Gastrointestinal symptom rating scale), WHOQOL (The World Health Organization Quality of Life) - BREF and Assessment of bowel function scores (frequency, consistency, ease of passage - based on Bristol stool scale) to assess the change of digestive symptoms and the quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Age of 18 - 75, with a elementary-school diploma or higher, must be literate
2. One who does not have any diseases or clinical symptoms related to digestive system
3. One whose every question of KGSRS is under 3 points
4. One who agree on not taking other therapies during the trial
5. During the past 5 yrs, no history of organic lesion proven by colonoscopy
6. One who agree on consent form

Exclusion Criteria:

1. Patients who have abdominal operation in the past (exception: appendectomy, caesarean section, tubal ligation, laparoscopic cholecystectomy, hysterectomy and abdominal wall hernia repair)
2. Patients who have history of serious diseases (cholangitis, pancreatitis, enteritis, ulcer, bleeding, cancer, etc.)
3. Before participating clinical trial, one who took over-the-count medication affecting GI motility
4. One who took antibiotics, herbal medicine or probiotics within 2 wks before participating the trial
5. Pregnant woman
6. One who disagree on the consent form
Cortical Excitability Using Transcranial Magnetic Stimulation and Neuronavigation Device

This study has two main goals :

* to investigate the impact of aging on cortical excitability (CE)
* to investigate the impact of "state dependency" on CE, using a cognitive task and an emotional one.

A Neuronavigation system of transcranial magnetic stimulation is used, and electromyographic response are recorded.


Eligibility Criteria:
Inclusion Criteria:

* male or female
* age 18-75
* signed informed consent
* normal physical examination

Exclusion Criteria:

* less 18 or more 75 years of age
* contra indication to TMS: epilepsia or seizures, metallic head devices, cardiac pacemaker, pregnancy, jet lag or severe insomnia the night before
* severe physical disease
* treatment with psychotropic drugs
* overt psychiatric disease
* alcohol consumption before the examination