cyrilzakka/clinical-trials huggingface dataset:
Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient?

To predict fluid responsiveness in anesthetized pediatric patient is not an easy task although anesthesia provider has to deal with this question on their daily practices. Today, very few parameters can help anesthesia provider to predict fluid responsiveness in the pediatric anesthetized patient. Therefore anesthesia provider are let with fluid challenge with high volume of fluid boluses to see if patient were fluid responsive or not. This could lead to fluid overload and it's associated morbidity. We would like to investigate if the cardiac output response to a mini fluid challenge of 3 ml/kg in 2 minutes would be predictive of the response to an usual fluid challenge of 15 ml/kg in 10 minutes in elective pediatric anesthetized patients.

The main objective is to determine whether the new test "the stroke volume variation after fluid challenge of 3ml/Kg" provides information about fluid responsiveness namely increased cardiac output. This new test will be compared to "gold standard" that is, "the stroke volume variation after standard fluid challenge of 15ml/Kg". It is the evaluation of the diagnostic accuracy of a diagnostic test based on an index obtained by transthoracic cardiac echocardiography for diagnosing fluid responsiveness. This index is the stroke volume variation measured by transthoracic cardiac echography.

The study will include anesthetized patients undergoing scheduled surgery. For hemodynamic optimization, these patients will benefit, early after anaesthetic induction, before the surgical procedure has started, from a fluid challenge of 15ml/kg achieved in two stages (3 ml/Kg then 12 ml/kg) separated by an interval of one minute. Three-time hemodynamic will be analyzed.

* T0: basal
* T1: one minute after first vascular filling with 3ml/Kg in 2 minutes
* T2: one minute after second vascular filling with 12 ml/Kg in 8 minutes which is performed one minute after the end of the first filling (a total of 15 ml/kg)

At each time, we will retrieve a collection of hemodynamic data (stroke volume, cardiac output) obtained by transthoracic echocardiography, standard method to assess fluid responsiveness. And at the same times, the PVI and hemodynamic parameters obtained by esophageal Doppler will be noted.

Eligibility Criteria:
Inclusion Criteria:

* pediatric patient for scheduled surgery
* from 8 to 30 kg of weight

Exclusion Criteria:

* denied from the child or their parents
* congenital cardiopathy
* cardiovascular shunt
* respiratory dysfunction
* hepatic dysfunction
* renal dysfunction
* intracranial hypertension
Transnasal Cooling for Migraine

This is a prospective, double-blind, sham-controlled, randomized study to assess the safety, tolerability, and optimal dose of the COOLSTAT Transnasal Thermal Regulating Device for acute treatment of migraine. The hypothesis is that evaporative cooling induced by the CoolStat using only ambient, dry air will reduce the pain and other symptoms of migraine headaches during an acute migraine episode.


Eligibility Criteria:
Inclusion Criteria:

1. Meets the International Classification of Headache Disorders (ICHD-3) diagnostic criteria for migraine with or without aura, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, ophthalmoplegic migraine, migrainous infarction).
2. Patient is between 18 and 80 years of age.
3. Patient experiences 2 to 8 migraine attacks per month.
4. Patient is in good reported general health, with no fever (\<38.3C/101F).
5. Patient has had diagnosis of migraine with or without aura over at least 1 year.
6. Migraine onset before 50 years of age.
7. Migraine prophylaxis medication unchanged for 6 weeks prior to study enrollment.
8. Able to attend treatment session within 6 hours of migraine onset, with 48 hours of pain freedom prior to onset of migraine attack.
9. Migraine pain severity of Grade 2 or Grade 3 on day of treatment.
10. Provision of signed and dated informed consent form.
11. Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria:

1. has difficulty distinguishing his or her migraine attacks from tension-type headaches
2. Patient has uncontrolled hypertension.
3. Patient has a fever (≥38.3C / 101F).
4. Patient has used opioid medication or barbiturates in the past month.
5. Patient has Medication Overuse Headache (MOH), New Daily Persistent Headache (NDPH) or Chronic Tension Type Headache (CTTH).
6. Patient has 15 or more headache days per month.
7. Patient has used acute treatment(s) for migraine in the 48 hours preceding treatment i.e. over-the-counter (OTC) medications, prescription medications, or medical device).
8. Patient has received Botox treatment, supraorbital or occipital nerve blocks in the last 4 weeks.
9. Intolerance to intranasal neurostimulation or sensory processing disorder that makes the treatment not applicable.
10. Recurrent epistaxis or chronic rhinosinusitis.
11. Recent facial trauma, sinus or intranasal surgery within the last 4 months.
12. Known or suspected pregnancy.
13. Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity.
Riluzole in the Treatment of Bipolar Depression

Bipolar disorder is a common and often chronic and debilitating mental illness. The depressive phase of bipolar disorder contributes the largest portion of the disorder, and treatment resistant bipolar depression represents a significant public health problem. Recent research has suggested that bipolar depression is associated with elevated brain glutamate activity. We hypothesize that riluzole, a drug approved for ALS which inhibits glutamate activity, will lead to clinical improvement in patients with bipolar depression.

We hypothesize that riluzole will lead to significant reduction in depressive symptoms as measured by the Hamilton Depression Rating Scale (HAM-D). Additionally, improvement in depressive symptoms will be associated with reduced glutamate levels in the anterior cingulate cortex, but not parieto-occipital cortex, both at day two and day 42.

Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18-65
* Meets DSM-IV criteria for Bipolar Disorder and is currently depressed
* Current score of \>/= 18 on the Hamilton Depression Scale

Exclusion Criteria:

* Active psychotic/manic symptoms
* Lifetime history of schizophrenia or obsessive compulsive disorder
* Clinically significant medical disease
* Women who are pregnant or lactating and women who are not using a medically accepted method of contraception.
Efficacy and Safety of Teneligliptin in Chinese Patients With Type 2 Diabetes Mellitus

This study is designed as a prospective, multi-centre, parallel group, double-blind randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety of MP-513 (Teneligliptin).


Eligibility Criteria:
Inclusion Criteria:

* A signed and dated informed consent form has been obtained from the subject, in accordance with International Conference on Harmonisation guidelines on Good Clinical Practice (ICH GCP), before any screening or study related procedures take place.
* The subject is aged ≥18 years at signature of the informed consent form.
* Hospitalization status: outpatient.
* The subject has had a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit (Day -28).
* The subject is undergoing diet and exercise therapy, and diet and exercise regimen has not been changed for at least 8 consecutive weeks at the screening visit (Day -28). Subjects who cannot do exercise due to complication are not limited to this criteria.
* The subject's glycosylated fraction of haemoglobin(HbA1c) is ≥ 7.0% and \< 10.0% at the screening visit (Day -28) and on Day -14.

Exclusion Criteria:

* The subject has a history of type 1 diabetes mellitus or a secondary form of diabetes.
* The subject has received insulin within 1 year prior to the screening visit (Day -28), with the exception of insulin therapy during hospitalization or insulin therapy for medical conditions not requiring hospitalization (\< 2 weeks' duration).
* The subject has received an anti-diabetic drug within 8 weeks prior to the screening visit (Day -28).
Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part IV

The overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO thermoregulation care alone. Part V is comparing use of a plastic torso wrap to no plastic torso wrap in preterm/low birth weight infants following removal from their incubator to assist with temperature regulation.

Due to limited resources and numbers of incubators, hospitals in developing countries remove infants from incubators at lower weights than in developed countries, putting infants at increased risk for hypothermia. This study will compare the incidence of hypothermia during the 72 hours after incubator removal of infants randomized to receive standard incubator removal (control group) or standard incubator removal with a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken upon removal from the incubator, every subsequent 6-8 hours, and finally, at 72 hours as the bags are removed. Blood pressure, blood sugar, seizures, weight gain, hyperthermia, death, observation for respiratory distress, bronchopulmonary dysplasia, sepsis, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, intestinal perforation, pulmonary hemorrhage room temperature and humidity, and length of time in an incubator will be recorded throughout their hospitalization for all infants. With an estimated hypothermia incidence of 30% and a hypothesized 20% absolute risk reduction (66% relative risk reduction), a sample size of 118 will be used to have a power of 80% and a confidence interval of 95%.

Eligibility Criteria:
Inclusion Criteria:

* Infant admitted to the NICU
* Current weight less than 2,000g
* Being removed from incubator

Exclusion Criteria:

* Abdominal wall defect or myelomeningocele
* Major congenital anomalies
* Blistering skin disorder
Application of Clinical Metagenomics in the Diagnosis of Ascites

Infection of the ascitic fluid is a serious complication associated with high morbidity and mortality. This fluid is often colonized with bacteria that can cause infection of the peritoneum and possibly sepsis. Many bacteria of the human intestinal microbiome can't be cultured by standard methods; therefore it seems likely that many of the relevant bacteria are not discovered in routine diagnostics, but may be relevant to pathogenesis. Culture-independent approaches such as NGS (Next generation Sequencing) have in principle made it possible to study or prove complex microbial colonization. Because NGS is a relatively new technology, microbiological diagnostic protocols need to be further customized and refined to integrate with the standard diagnostic workflow, if necessary. For microbiological diagnostics, material is collected from the appropriate ascites patients and sent for microbiological diagnostics. Afterwards the cultural diagnostics are carried out as part of the patient care at the university hospital. In this study the investigators plan to use these samples to analyze and compare the presence of bacteria by NGS in parallel to the culture diagnostics, and then compare it to the patients' gut microbiome, to understand the possible effect of the microbiome on ascites pathogenesis and outcome.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ≥ 18 years of age
* Samples from patients who have ascites puncture to exclude infection
* Written consent of the patient after clarification

Exclusion Criteria:

* Minor patients
* Non-consenting patients
* Samples without sufficient residual material after standard diagnostics
* Samples from patients who have not consented to the examination.
Survivorship Care Planning in Improving Quality of Life in Survivors of Ovarian Cancer

This pilot clinical trial studies survivorship care planning in supporting quality of life in ovarian cancer survivors following primary treatment. Survivorship care plans have the potential to empower patients and provide them with a plan of care following treatments. Survivorship care planning may support patient's overall well-being and quality of life after treatment of ovarian cancer.

PRIMARY OBJECTIVES:

I. To assess the feasibility and acceptability of survivorship care planning (SCP) in ovarian cancer.

SECONDARY OBJECTIVES:

I. To develop the infrastructure and strategy for a larger comparative intervention study (National Cancer Institute \[NCI\] R01).

OUTLINE: Participants are assigned to 1 of 2 arms.

ARM I: Participants receive standard post-treatment care consisting of regular cancer surveillance visits with treating oncologists.

ARM II: Participants complete survivorship care planning in close collaboration with treating oncologists.

After completion of study treatment, participants are followed up at 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stage I, II, or III ovarian cancer
* Ability to read or understand English
* All subjects must have the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Effect of BIS Monitoring on Propofol Usage During Elective Bronchoscopy

In this research, the investigators will asses the effect of BIS monitoring on propofol usage during elective flexible fiberoptic bronchoscopy.

The investigators will examine whether use of BIS monitor enables reduction of sedative dose during bronchoscopy.

The investigators will also examine whether administration of lower total sedative dose enables prevention of possible complications.

During flexible fiberoptic bronchoscopy (FFP) a narrow optic tube is inserted via the mouth or nose into the airways. This allows direct visualization of the airways as well as taking different samples. In addition, this procedure allows opening of airway obstruction.

Administration of sedation during FFP is important, since this diminishes patient discomfort and body movements. It also lessens the untoward physiologic response to airway manipulation. In addition, patients requiring repeated examinations may refuse if they have suffered an unpleasant experience.

FFP is usually a brief procedure (several minutes up to an hour). Therefore, it is advantageous to use short acting drugs in order to shorten the prolonged post procedural monitoring and allow rapid patient discharge.

Several clinical trials have shown the superiority of propofol over midazolam for sedation during bronchoscopy regarding recovery of alertness, memory \& motor function.

Propofol is a sedative-hypnotic with rapid onset and short duration. Using propofol, one can achieve rapid onset of sedation and faster recovery.

Propofol given in boluses of 10-20 mg was found as an effective dose to reach BIS target values.

Awareness is the postoperative recollection of events occurring during general anesthesia.

BIS is a monitor of anesthetic depth approved by the FDA. It incorporates time-domain, frequency-domain and bi-spectral analysis of the EEG. This analysis is displayed as a dimensionless number between zero (deep anesthesia) and 100 (awake).

BIS values between 80-90 represent values corresponding to light/moderate sedation

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Undergoing flexible fiberoptic bronchoscopy for lung tissue biopsy, airway lavage or opening of airway obstruction.

Exclusion Criteria:

* Patient refusal/ inability to sign informed consent.
* Age under 18 years of age.
* Ventilated patients (via endotracheal tube or tracheostomy).
* Known allergy for one of the anesthetic drugs.
* Patients who suffered a stroke and/or have other neurological diseases.
* Hemodynamically unstable patients (SBP below 90mmHg or above 180mmHg).
Does the Order in Which Vaccines Are Administered Affect Pain Response?

The objective of this study is to determine whether there should be a predetermined sequence recommended for administering these two vaccines, with the less painful vaccine being given first.

Childhood vaccination is one of the most effective public health measures worldwide, with few serious adverse effects reported. However, pain on vaccination continues to be a frequent occurrence and is the most common cause of childhood iatrogenic pain. In a recent study of paediatricians in the USA, more than ninety percent reported at least one parental vaccine refusal in the past year. The most common concerns cited by parents were short-term reactions and pain from multiple injections.

One of the factors responsible for vaccination pain is the vaccine material itself. Even the same vaccine, when made by different pharmaceutical companies may produce different pain responses. Anecdotal reports from doctors and nurses indicate that Pentacel (DPTaP+Hib) is a relatively painless vaccine to administer whereas Prevnar (conjugated pneumococcal vaccine) causes significant pain on injection and severe distress to the infant being vaccinated. For this reason, many vaccinators administer Pentacel \[DPT\] prior to Prevnar \[PCV\] when providing both vaccines in one visit. However, the difference in infant pain responses has not been documented. Although it has been shown that very early pain events affect infants' later experience of pain, it has not been demonstrated that the sequence in which vaccines are administered affects pain response. This study will assess whether there should be a predetermined sequence recommended for administering these two vaccines, with the less painful vaccine (Pentacel) being given first.

Eligibility Criteria:
Inclusion Criteria:

* Healthy infant
* 2 - 6 months of age
* receiving primary DPT and PCV vaccinations

Exclusion Criteria:

* chronic illness
* immune deficiency
* immunosuppression
* a history of allergy to DPT or PCV or any of its components
* fever
* any acute illness that prevents the administration of the vaccine
Effectiveness of Breathing Exercises as Therapeutic Play on Respiratory Status Among Children With Lower Respiratory Tract Disorders

The study evaluates the effectiveness of Breathing Exercises as Therapeutic Play on respiratory Status among children with Lower respiratory Tract Disorders. patient were allocated into two groups- Experimental group and Comparison group. Experimental Group received Breathing Exercises as Therapeutic Play after administration of Nebulization therapy and comparison Group received no Breathing Exercises.

The subjects were selected by Purposive sampling technique and allocated into 2 groups i.e experimental and comparison group. the total sample size for the study was 60 children i.e 30 in Experiment Group and 30 in Comparison group.

Experimental Group- Pre-assessment of respiratory status among children was assessed. Then after 5 minutes of administration of Nebulization, breathing exercises as therapeutic play (balloon inflation, candle blowing, blow air into water with a straw was administered for 15 minutes once in a day for 3 days consecutively and then post-assessment was taken daily 5 minutes after the administration of breathing exercises as therapeutic play.

Comparison Group- Pre-assessment of respiratory status among children was assessed. Then only nebulization therapy was administered and then post-assessment was taken daily after 25 minutes of administered.

Eligibility Criteria:
Inclusion Criteria:

* 5-18 years of age
* prescribed with Nebulization therapy
* able to understand hindi.
* available during the period of data collection and willing to participate in study.

Exclusion Criteria:

* having upper respiratory tract infection
* on ventilator support.
* coming to hospital for OPD visits.
International Alfapump Cohort Study

This Registry is designed to follow patients who have been implanted with an alfapump system, which is a newly marketed product from Sequana Medical AG, a Swiss Medical Device company.

In a real-world setting, all patients implanted with an alfapump system according to it's intended use, not participating in another clinical study in which the alfapump is studied.

Eligibility Criteria:
Inclusion Criteria:

* All patients implanted with an alfapump are eligible for this registry

Exclusion Criteria:

* Patients younger than 18 years
* Pregnancy
* Inability to operate the Smart Charger to recharge the alfapump
* Participating in another study in which the alfapump is studied
Trancutaneous Abdominal Stimulation on Bowel Function.

This is a prospective, single-center, feasibility study to determine the sensations elicited by non-invasive abdominal electrical stimulation and its effects on bowel function in spinal cord injured individuals and in able-bodied persons with chronic constipation. Electrical stimulation will be delivered through commercially available equipment to each subject during a single site visit.

This is a prospective, single-center, treatment feasibility study to determine the efficacy of electrical stimulation for bowel functions. The study will determine sensations elicited by non-invasive, transcutaneous abdominal electrical stimulation and its effects on bowel function in spinal cord injured individuals and in able-bodied persons with chronic constipation. The electrical stimulation will be delivered through commercially available equipment to each subject during a single site visit. Visits are anticipated to be no more than 5 hours.

Eligibility Criteria:
Inclusion Criteria:

* For spinal cord injury subject group:

  * Traumatic or non-traumatic spinal cord injury;
  * Constipation;
  * Motor-complete or motor-incomplete spinal cord injury;
  * Quadriplegia or paraplegia;
  * Post-injury time ≥ 1 year;
  * Neurogenic Bowel Dysfunction Score ≥ 7.
* For able-bodied subject group:

  * Diagnosis of intestinal constipation according to the Rome IV criteria;
  * Chronic constipation as defined by \< 3 bowel movements per week for \> 3 months.
* For both subject groups:

Can read, understand and willingly sign an Institutional Review Board approved informed consent document that describes the study's risks and benefits.

Exclusion Criteria:

1. Presence of any organic cause for intestinal constipation;
2. Have chronic fecal incontinence;
3. Have skin infection/lesion in the area of electrode application or systemic skin disease;
4. Have an implanted electronic device (such as heart pacemaker, insulin or baclofen pump, etc);
5. Have symptomatic cardiac disease;
6. Have uncontrolled diabetes;
7. Presence of abdominal hernia;
8. Have a stoma, rectal tear, or untreated hemorrhoids;
9. Have a significant psychiatric disorder;
10. For female subjects, being pregnant, actively planning a pregnancy or breast-feeding a child;
11. Be participating in another clinical study that would confound data analysis;
12. Have a cognitive impairment or exhibits any characteristic that would limit the study candidate's ability to complete study assessments.