cyrilzakka/clinical-trials huggingface dataset:
Hemodynamic Management in Autologous Blood Collection for CABG Surgery

In this study, investigated the hemodynamic differences between patients who underwent acute normovolemic hemodilution during the Autologous Blood Collection procedure in coronary artery bypass graft surgery and those who did not, using hemodynamic and cardiac data obtained by MostCare's pressure recording analytical method (PRAM).

Coronary artery bypass graft (CABG) surgeries are surgeries in which the need for blood transfusion is high. Allogeneic transfusion and transfusion-related complications have led researchers to use different techniques. Autologous blood collection method is one of the alternative methods used to eliminate the need for transfusion. The acute normovolemic hemodilution technique traditionally applied during autologous blood collection causes hemodilution in CABG surgeries and increases the risk of bleeding in patients. In this study, vasopressor infusion technique was used as an alternative technique to avoid hemodilution during autologous blood collection. These two techniques (Acute normovolemic hemodilution - Vasopressor infusion) applied to maintain hemodynamic stabilization during autologous blood collection were compared with the advanced cardiac and hemodynamic data provided by the pressure recording analytical method. The primary aim of the study was to compare cardiac cycle efficiency (CCE), which is a cardiac performance parameter and provides estimates of the energy spent by the cardiovascular system to maintain hemodynamic balance. Secondary objectives are to compare other advanced hemodynamic and postoperative laboratory parameters.

Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years
* Undergoing isolated coronary artery bypass grafting surgery under general anesthesia
* Invasive blood pressure (radial or femoral) and Mostcare monitoring
* Recruitment after booking for surgery with sufficient time to read, understand and question study patient information prior to attending for surgery
* Ability and willingness to provide informed consent

Exclusion Criteria:

* Refuse to consent to the study
* Arterial wave form distortion
* Cardiac arrhythmia
* Inappropriate identification of the dicrotic notch for any reason
* Hemodynamic instability defined as mean arterial blood pressure \< 65 mmHg
* Preoperative requirement of inotrope/vasopressor infusion
* Preoperatively receiving vasoactive drugs
* Patients fitted with an intra-aortic balloon pump
* Patients fitted with Extracorporeal Membrane Oxygenation
* Critically ill patients requiring preoperative intensive care unit
* Presence of intraabdominal hypertension
* New York Heart Association Class 3-4 heart failure
* Congestive heart failure with ejection fraction \< 35%
* Glomerular filtration rate \< 30 ml/min/1.73 m2
* Ongoing renal replacement therapy
Gastric Electrical Stimulation (GES) for the Treatment of Obesity

The purpose of this feasibility study is to provide safety data on the implantable Exilis gastric electrical stimulation (GES) system, to individually adjust stimulation parameters to levels that are comfortable for implanted subjects during chronic daily treatment, and to collect data on acute gastrointestinal function and food intake responses to GES during in-clinic testing.


Eligibility Criteria:
Inclusion Criteria:

* Adults ages 21-64 with BMI of 40-45 kg/m\^2 or BMI 35-39.9 kg/m\^2 with at least one obesity-related comorbidity, who have failed prior non-surgical weight loss attempts, and have been within 5% of their current weight for at least one year.
* If diabetic, subject has non-insulin-dependent type 2 diabetes mellitus diagnosed within the last 7 years, and has an HbA1c level less than 8%.
* If female and of child-bearing age, subject is not pregnant or lactating and is willing to use effective contraception for the duration of the study.
* Subject is willing and able to complete scheduled study visits, complete on-line lifestyle educational modules, and complete required procedures.

Exclusion Criteria:

* Subject has a history of medical, surgical, or psychiatric conditions that, in the opinion of the Investigators, would limit study participation or contraindicate implantation of the Exilis GES system. Examples includes cardiac abnormalities contraindicating surgical anesthesia, prior gastrointestinal surgery, gastrointestinal motility disorders, inflammatory bowel disease, a history of eating disorders, anticipated future need for magnetic resonance imaging, or allergies to food ingredients in study test meals.
Triple Therapy With Tegoprazan in H. Pylori Positive Patients_PILOT

This study aims to compare safety and efficacy in an exploratory manner between a Tegoprazan triple therapy and a RAPAE01 triple therapy in H. pylori positive patients.

A Randomized, Double-Blind, Active-controlled, Multicenter, Pilot Study to Investigate the Safety and Efficacy of a Tegoprazan triple therapy and a RAPAE01 triple therapy in H. pylori positive patients.

Eligibility Criteria:
Inclusion Criteria:

* H. pylori positive at screening
* Subjects who have upper gastrointestinal disease

Exclusion Criteria:

* Having received prior therapy for eradication of H. pylori
* Prior use of P-CAB, proton pump inhibitors (PPIs), H2 receptor blockers within 14 days
* Prior use of H. pylori eradication effective antibiotics, bismuth within 28 days
Ultrasound-guided Lung Recruitment Maneuvers for Postoperative Pediatric Atelectasis

In anesthetized children, the incidence of lung collapse with episodes of hypoxemia is high. Diaphragmatic dysfunction induced by general anesthesia is one of the most important factors in the genesis of regional losses of lung aeration. The mass of the abdominal organs pushes the diaphragm cranially compressing the lungs in the most dependent areas. Such regional lung collapse may range from a slight loss of aeration to complete atelectasis.

A wide variety of recruitment maneuvers has been described. The most relevant are represented by sustained inflation maneuvers, high pressure-controlled ventilation, incremental PEEP, and intermittent sighs. However, the best recruitment maneuver technique is currently unknown and may vary according to the specific circumstances. The most commonly used recruitment maneuver is the sustained inflation technique, in which a continuous pressure of 40 cm H2O is applied to the airways for up to 60 seconds. Sustained inflation has been shown to be effective in reducing lung atelectasis, improving oxygenation and respiratory mechanics, and preventing endotracheal suctioning-induced alveolar derecruitment. However, the efficacy of sustained inflation has been questioned and other studies showed that this intervention may be ineffective, short-lived, or associated with circulatory impairment, an increased risk of baro/volutrauma, a reduced net alveolar fluid clearance, or even worsened oxygenation.

Lung ultrasound has been gaining consensus as a noninvasive, radiation-free tool for diagnosing various pulmonary diseases in adult and pediatric patients. Evidence supporting lung ultrasound use is expanding beyond emergency and critical care settings to perioperative care.

It has been reported that lung ultrasound (LUS) at a patient's bedside immediately following surgery can be useful for diagnosing respiratory complications. LUS has been proven to be a valuable bedside diagnostic tool for pneumothorax, with high sensitivity and specificity (78.6% and 98.4%, respectively), and a higher rate of detecting abnormalities such as lung alveolar consolidation and pleural effusion than bedside chest X-ray or physical examination. LUS has also been used to diagnose anesthesia-induced atelectasis in pediatric patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for laparoscopic abdominal surgery
* American Society of anaesthesiologist class I \& II

Exclusion Criteria:

* Pre-existing cardiac disease.
* Morbidly obese patients according to age.
* Patients with previous thoracic or cardiac surgery.
* Upper or lower airway infection within 2 weeks before the surgery.
* Lung ultrasound abnormalities including patches, pneumothorax, and pleural effusion.
* Abnormal preoperative chest x-ray findings including atelectasis, pneumothorax, pleural effusion or pneumonia.
* Preoperative oxygen saturation measured by pulse oximetry (SpO2) of 96% or less on room air.
Influence of Gender Specific Differences of Saliva Composition on the Development of Dental Erosion - an In-situ Study

Healthy volunteers are observationally wearing an intraoral device with bovine tooth samples once for two hours. Afterwards, Calcium release from the bovine enamel and dentin samples is measured after extraoral erosion.

Total protein concentration within the formed salivary pellicles on the bovine samples is determined. Further Salivary parameters (unstimulated and stimulated saliva flow rate, pH, buffer capacity, albumin and total protein content as well as concentration of inorganic calcium, phosphate and fluoride) are being measured.

The aim of this study is to investigate whether gender differences in the salivary composition correlate with predisposition to erosion.


Eligibility Criteria:
Inclusion Criteria:

* Healthy probands aged between 20 and 40 years who are able to give written consent

Exclusion Criteria:

* Non-fulfillment of the inclusion criteria
* Smoking
* Hyposalivation / xerostomia (unstimulated saliva \< 0.3 mL/min, stimulated saliva \< 0.7 mL/min)
* Intake of any medication (except contraceptives in women)
* Pregnant or lactating women
* Known allergies to substances used in the study
* Orthodontic treatment or malfunction which doesn't allow to wear an intraoral device
Efficacy of Voriconazole Loaded Spanlastics Gel Versus Clotriamazole Cream on Treating Vulvovaginal Candidasis

To investigate and compare the efficacy of voriconazole loaded spanlastics (VCZ loaded SPs) optimum gel formula (F2 VCZ loaded SP gel) versus Clotrimazole cream in treating candida albicans causing vulvovaginal candidiasis for different durations of 3 days and 5 days.

The current study will be prospective controlled randomized clinical trial. 28 female patients suffering from vulvovaginal candidiasis will be enrolled in the following 2 groups:

Gp 1 (Test group): including 14 patients with vulvovaginal candidiasis albicans that will be randomized in the following subgroups:

Gp 1a: will be treated with F2 VCZ loaded SP gel for 3 days. Gp 1 b: Will be treated with F2 VCZ loaded SP gel for 5 days. Gp 2 (Control group): including 14 patients with vulvovaginal candidiasis albicans will be randomized in the following sub groups Gp 2 a: will be treated with the Clotrimazole cream available in the market for 3 days.

Gp 2 b: Will be treated with the Clotrimazole cream available in the market for 5 days.

Smears will be taken from the patients before starting the therapeutic protocol and after finishing it. Compliance of the patients to the creams will be assesses

Eligibility Criteria:
Inclusion Criteria:

* Female patients aging from 20 t0 40 years old suffering from vulvovaginal candidiasis caused by albicans species.

Exclusion Criteria:

* Pregnant women, female suffering from vulvovaginal candidiasis caused by other species rather than C. albicans.
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

The purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of UC for at least 12 weeks prior to screening, confirmed by endoscopy with biopsy.
* Active ulcerative colitis with a Mayo Score of 6 - 12 points and endoscopy subscore of 2 - 3 despite concurrent treatment with oral corticosteroids or immunosuppressants or both.

Exclusion Criteria:

* Subject with Crohn's disease (CD) or indeterminate colitis (IC).
* Current diagnosis of fulminant colitis and/or toxic megacolon.
* Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.
* Chronic recurring infections or active tuberculosis (TB).
Pressure Relief Algorithm Eval

The PRA Effect on APAP Therapy Pressure Study is a randomized, controlled, crossover study in PAP-adherent participants with OSA. Pre-screening is conducted to establish potential eligibility based on regular usage of \> 4 hours/night on patients who use an APAP device with a PRA mode. Participants would then be recruited as described below. For those who sign an informed consent, they will be instructed to use the device for the next 8 days with the PRA turned on for four consecutive nights and off for four consecutive nights, but in random orientation. To make sure that the device is not limited to APAP range when adjusting to respond to PRA, the upper limit will be changed to 20 cmH2O during the study. Additionally, only patients who have a current P95 of 8 cmH2O or greater will be eligible so that the maximum PRA setting of 3 cmH2O can be used.

The first phase of recruiting for the PRA Effect on APAP Therapy Pressure Study will be done during a single phone contact following an email recruitment. During this call, participants will be explained the study along with risks and benefits and evaluated for inclusion and exclusion criteria. If the participant is eligible to enter the study, they will be sent an electronic Informed Consent Form to sign. Once the form is signed and verified, the study can then start that evening, after the participant's device has been set for the study.

During both arms of the study, every aspect of operation of the APAP devices will be the same as those the patient normally uses, except for the following three things:

* APAP upper range limit will be set to 20 cmH2O
* PRA or 3 cmH2O will be either on or off
* Participants cannot use a V̇-Com™ device. Participants will randomly be assigned to start with or without PRA. Once the settings are remotely assigned to the device, the patient will sleep on these settings for four nights, ideally consecutively.

After four nights, the PRA setting will be remotely switched to the 2nd arm setting (on or off), and median and P95 pressure, Usage, AHI, and Leak averaged over those four nights will be downloaded. The participant will then use the device with the new settings for an additional four nights, hopefully also sequentially.

Following the 2nd group of four nights, median and P95 pressure, Usage, AHI, and Leak averaged over those four nights will be downloaded, the participant will be informed that their involvement in the study is complete, and the device will be remotely set back to the settings it had prior to the study. Participants will then receive the compensation credit.

Eligibility Criteria:
Inclusion Criteria:

1. Adherent use of ≥ four hours/night over previous 2 months.
2. P95 ≥ 8 cmH2O.

Exclusion Criteria:

1. Excessive alcohol consumption (\>14 drinks/week).
2. The use of any illegal drug(s).
3. Any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.
To Verify the Efficacy and Safety of Rapamycin Coated Peripheral Balloon Catheter in the Treatment of Femoral Popliteal Artery Disease

A prospective randomized trial to validate the efficacy and safety of rapamycin coated peripheral balloon catheter in the treatment of femoral popliteal artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with arteriosclerosis obliterans of lower extremities, and Rutherford's rating is 2-5.
* Patients with severe stenosis (≥ 70%) or occlusion of superficial femoral artery and/or proximal popliteal artery (within P1 stage)
* Patients with total length of target lesion ≤ 20cm and length of occluded segment ≤ 15cm (the distance between two segments of lesions less than 2cm is considered as the same lesion)
* Those who agree to participate in this clinical trial and sign the informed consent form Exclusion criteria：
* This operation is planned to intervene patients with bilateral lower limbs.
* Patients whose guide wire fails to pass through the target lesion.
* Patients whose target lesion is in stent restenosis (ISR).
* ≥ 2 lesions need to be treated in the target vessel (if the distance between two lesions is less than 2cm, it is considered as the same lesion).
* Patients with target lesions requiring rotary resection/laser therapy/thrombus aspiration for this treatment.
* Patients with ipsilateral iliac artery inflow tract lesions that cannot be successfully treated (i.e. residual stenosis ≥ 30% after treatment).
* There is less than one unobstructed blood vessel under the knee of the target limb before operation (unobstructed is defined as visual stenosis\<50%).
* Residual stenosis ≥ 30% after pre expansion of target lesion or severe (≥ Grade D) flow limiting dissection.
* Patients with obviously abnormal renal function (creatinine \> 2.5mg/dL or 220umol/L) or undergoing dialysis.
* Patients with severe liver dysfunction who are judged by the researcher to be unsuitable for surgery.
* Patients with severe coagulation dysfunction or uncontrolled severe infection who are not suitable for surgery.
* Patients who have performed distal amputation (above metatarsal) on the affected or opposite limb in the past.
* Patients who received local or systemic thrombolytic therapy within 48 hours before surgery.
* Patients receiving vascular interventional therapy or surgical treatment on target limb within 30 days before operation.
* Patients known to be allergic to aspirin, clopidogrel, paclitaxel and rapamycin.
* Pregnant or lactating women and patients with family planning during the study
* Patients who are participating in clinical trials of other drugs or medical devices but are not included in the group.
* Patients with life expectancy less than 12 months
* Patients not suitable for this study.
Participant(s) With Autism and High Pain Tolerance Treated With High Dose Naltrexone

High dose naltrexone with response gauged by pain tolerance as measured by the cold pressor test may help treat autism.

Clinical Trial: Cause and Treatment of High Opioid Tone Autism Key Words: autism, neurobiological systems engineering, opioid tone, cold pressor time, clinical trial Abstract Introduction: Neurobiological systems engineering models are useful for treating patients. We show a model of "high opioid tone" autism and present a hypothesis about how autism is caused by administration of opioids during childbirth.

Main Symptoms: Clinical diagnosis of autism in a 25 year old man was confirmed by a Social Responsiveness Scale (SRS) self - rating of 79, severe, and a Social Communications Questionnaire (SCQ - 2) by the patient's father scoring 27. Cold pressor time is a measure of pain tolerance obtained by having the subject submerge their normal forearm in a painful ice water bath. Cold pressor time (CPT) was 190 seconds - unusually long, consonant with the high pain tolerance of autism.

Therapeutic Intervention and Outcome Measure:

Primary Outcome Measure is the Cold Pressor Time (CPT). At naltrexone 50 mg/day CPT fell to 28, repeat 39 seconds.

Secondary outcome measures are Social Responsiveness Scale (SRS) and Social Communications Questionnaire (SCQ-2). SRS fell to 54 and SCQ - 2 to 9; both non - significant for autism.

Change in relatedness was experienced ambivalently, understood as feelings never before experienced - causing pain. Non - compliance with naltrexone was followed by cutting open his palm and drinking alcoholically. Transference focused psychotherapy has helped him remain naltrexone - compliant while he works on issues of identity and relatedness.

Conclusion: The model suggests studies that could be conducted to both prevent and treat this form of autism.

Eligibility Criteria:
Inclusion Criteria: Diagnosis of autism -

Exclusion Criteria: Lack of ability to give informed consent

-
Effect of Vibration on Muscle Properties, Physical Activity and Balance in Children with Cerebral Palsy

The aim of the 6-month randomized controlled trial, with 6-month no treatment follow-up, is to examine the effects of low-magnitude vibration on muscle, physical activity, and balance in children with spastic cerebral palsy.

Cerebral palsy (CP) is a movement disorder that affects over 800,000 people in the U.S. Due to the limited mobility associated with the disorder, individuals with CP have an increased risk of chronic diseases, such as cardiovascular disease, diabetes mellitus and osteoporosis, compared to the general population. Therefore, identifying treatment strategies is of utmost importance. The aim of this study is to examine the acute and chronic effects of low-magnitude vibration on muscle, physical activity, and balance in children with CP. Fat concentration and muscle will be assessed using imaging techniques. Physical activity will be assessed using activity monitors. Balance will be assessed using clinical and biomechanical tests. Children with CP will be tested at five time points: baseline, 1 and 6 months after standing on a vibration platform daily 10 minutes per day, 1 and 6 months post treatment (7 months and 12 months from baseline, respectively). The findings from the proposed study will help us determine if vibration shows promise as a treatment for the impaired mobility, lower physical activity and higher risk of chronic disease in individuals with CP.

Eligibility Criteria:
Inclusion Criteria:

* Spastic cerebral palsy
* Independent ambulator without an assistive device (Gross Motor Function Classification System level I or II)

Exclusion Criteria:

* Prior fractures in both femurs or tibias
* Currently taking bisphosphonates
* Unable to stand independently
* Orthopedic surgery on a lower extremity within the last 6 months
* Children with pure athetoid CP
* Baclofen pump in the abdomen
* Botox treatment within the last year
Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation

The purpose of the study is to assess combining AF ablation, with AV node ablation and pacemaker implantation for patients suffering with 'irregular heartbeats' or atrial fibrillation. The study will last 13 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic drug refractory atrial fibrillation.
* Patients who have had pacemaker implantation and AV node ablation with ongoing symptoms.
* Patients will already be refractory to at least 2 rate or rhythm control drugs.
* Patients must be over 18 years old.
* Patients give informed consent form prior to participating in this study.

Exclusion Criteria:

* Patient is suffering with unstable angina in last 1 week.
* Patient has had a myocardial infarction within last 2 months.
* Patient is expecting or has had major cardiac surgery within last 2 months.
* Patient is participating in a conflicting study.
* Patient is unable to perform exercise testing.
* Patient is mentally incapacitated and cannot consent or comply with follow-up.
* Patient has NYHA class III/ IV heart failure.
* Patient has LVEF \<35% not secondary to tachycardia.
* Pregnancy.
* Patient suffers with other cardiac rhythm disorders.
* Recent coronary artery intervention or other factors suggesting clinical instability (ECG, clinical or laboratory findings).