cyrilzakka/clinical-trials huggingface dataset:
Droperidol on Prevention of Cannabis Hyperemesis Syndrome

The purpose of this study is to assess the efficacy of droperidol as a treatment of cannabinoid hyperemesis syndrome.

Patients presenting to the Emergency Department with nausea, vomiting and/or abdominal pain with a significant history of cannabis use and symptoms in a cyclic pattern will be assessed for study inclusion. After given written informed consent, patients will be treated with droperidol and diphenhydramine and symptoms will be assessed using a visual analog scale at time intervals up to 120 minutes. Patient will then be contacted at 24 and 48 hour intervals to assess symptoms on the same scale. This is a multicenter, prospective interventional study with results compared to a historical cohort using haloperidol.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 years of age or older and presenting with cannabis hyperemesis syndrome requiring intravenous medication.

Exclusion Criteria:

* any patient with a contraindication to the use of droperidol
* Corrected QT interval on ECG greater than 440 milliseconds for males and greater than 450 milliseconds for females
* any prisoners
* pregnant females.
Prediction of Response to Bariatric Surgery in Patients With Severe Obesity

This is an retrospective and prospective (ambispective) study with data collection from volunteer patients who passed an MMPI-2-RF (Minnesota Multiphasic Personality Inventory-2-Restructured form) questionnaire in the preoperative phase of a bariatric surgery project.

The evolution of their BMI will be correlated to psychological dimensions collected in patient questionnaires, before and after bariatric surgery.

The presence of possible risk factors such as depression, anxiety, eating disorders, quality of life, satisfaction and the perception of body, could make it possible to establish adapted therapies before surgery, in order to attenuate or eliminate the presence of these factors, and improve BMI evolution and bariatric surgery success.

A first phase of data collection will concern data from the MMPI-2-RF questionnaire as well as clinical data, collected during preoperative consultations.

For the second phase, post-operative data will be collected, during a routine follow-up consultation in the nutrition Department, where specific psychological questionnaires are taken by patients.

Eligibility Criteria:
Inclusion Criteria:

* Having been treated in the Nutrition department for severe obesity and considered for bariatric surgery because having met the criteria validating bariatric surgery:
* Having passed the MMPI-2-RF questionnaire between January 1, 2014 and December 31, 2023 in the preoperative phase, as part of psychological follow-up
* Having benefited from bariatric surgery or patients who have abandoned the surgery plan for a reason other than a medical contraindication.
* Informed of the study, having agreed to participate and not having opposed the use of their data

Exclusion Criteria:

* Subjects who generated an invalid MMPI-2-RF questionnaire, according to the test validity criteria (verified by the principal investigator)
* Subjects who expressly objected to the use of their data for this study
* Subjects who have not undergone bariatric surgery due to a medical contraindication.
* Patient unable to understand the study or complete the post-operative phase visit
* Persons under guardianship or curators or under legal protection
Tertiary Care for Visual Developmental Disorders in Pre-school Children

Visual development disorders are major public health problems among children especially in China. How to find an effective and economic way to manage the larger number of children in China remains exploring. The national basic public health services of China offer visual acuity screening for preschool children for free every year. The aim of this study is to demonstrate the feasibility, cost-effective and the influence factors of compliance of tertiary care for visual developmental disorders in pre-school children after screening, and whether this disease management model is more effective and superior than the current medical care in china.

Visual development disorders including amblyopia , strabismus ,refractive error are an important public health problem among children, and the visual impairment caused by visual development disorders is lifelong and can be profound. Timely discovering and treatment of visual development disorders are significant for the recovering of visual function in children. The national basic public health services of China offer the basic visual acuity screening every year for free. In this study, the investigators try to explore the cost-effective and compliance of the national basic public health services based tertiary care model for the management of visual development disorders among preschool children. This Tertiary care based on disease management model among preschool children was conducted at Yudu county, Jiangxi province, in China. Preschool vision screening relied on the national basic public health services of China (refractive errors examined by the Retinomax autorefractor). Children who failed the screening were randomized into two groups, the intervention group: their parents will be informed and transferred to an ophthalmologist and optometrist at Ophthalmic Referral Center, receiving basic eye examination and therapy (visual corrected by glasses and periodic review); The control group: their parents will be informed and suggest them to take their children to the hospital for further examination by themselves.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are aged 4-7 years and of Chinese citizen
2. Who is willing to sign the consent form
3. Children at the kindergarten will receiving the eye diseases screening of public health equalization programs in China, and there are abnormal findings after screening

Exclusion Criteria:

1. Unwilling to sign the consent form
2. Exiting eye diseases and already receiving therapies and follow up
Aquatic Exercise and Metabolism in Women

Exercise training on an immersible ergocycle is becoming more popular as it appears to be more suitable for men and women even with poor physical activity level. Commercial tagline highlight beneficial effect of this activity on weight management. However there are poor information concerning the energy response induced by this activity. The aim of this project is to investigate energetic response (energy expenditure and food intake) of a single bout of cycling exercise in water vs on dryland in normal weight and overweight premenopausal women.

After inclusion visit, all subject will be submitted to DXA to obtain body composition data. Then subjects will be submitted to four experimental session in a semi-randomized order. For all those session, subjects will take a standardized breakfast (570kcal) three hours before experimental session.

Control session (CON): subject will stand sited without any activity during 30 min.

Water exercise session (WAT): subject will exercise on an immersed ergocycle during 30 min at 50 rpm.

Dryland session 1 (LAND-1): subject will exercise on dryland, on the same ergocycle than in WAT session, during 30 min at 50 rpm.

Dryland session 2 (LAND-2): subject will exercise on dryland on the same ergocycle than in WAT. Intensity of exercise will be set at the same heart rate average than in WAT session, exercise will be stopped when subject will have reached the same energy expenditure than during WAT session.

During each session, energy expenditure, heart rate and rate of perceived exertion will be measured at 15 min and 30min.

Appetite and hunger sensation will be measured with a specific scale at different time point of each day of experimental session. Thirty minutes after the end of each experimental session subjects will have a buffet meal for lunch time.

Eligibility Criteria:
Inclusion Criteria:

* Women aged between 23 and 40 years
* BMI under 25kg.m2 for normal weight women and between 25 and 29,9 kg.m2 for overweight women
* Daily breakfast
* Subject which approved informed consent
* Subject with French medical affiliation

Exclusion Criteria:

* Specific medical treatment
* Aquaphobia
* Subject under specific diet regimen or weight loss program
* Subject with cardio-vascular disease
* Surgical intervention less than 3 months
* Subject refusing informed and written consent
* Subject without French medical affiliation
* subject refusing inscription to the national voluntary list
* subject being in an exclusion period
* subject smoking or drinking alcohol frequently
* subject with intense physical activity
Hypocaloric Mediterranean Diet or Physical Activity to Lower Cardiometabolic Risk

The purpose of this randomized controlled trial is to test the effects of a hypocaloric Mediterranean diet or of physical activity in participants who take at least 2 antihypertensive drugs but do not reach blood pressure treatment goal.

This study is a randomized, controlled, single-center, parallel group trial with three arms: hypocaloric Mediterranean diet (MeDi), physical activity (PA), or control. The control group will receive usual care (no intervention). This study will not be blinded.

The interventions will last 6 months, while the study follow-up will last 12 months. Four study visits will take place: baseline, at 3 months, at 6 months, at 12 months. The primary outcome is change in mean 24-hour ambulatory systolic blood pressure and diastolic blood pressure among groups after 6 months of intervention. Secondary and exploratory outcomes include change in other measures of blood pressure, body composition, other markers of cardiometabolic disease, inflammation markers, safety outcomes, and quality of life, among others.


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* 18 - 70 years
* Taking ≥ 2 antihypertensive drugs (includes combination therapy)
* Office SBP ≥ 140mmHg and/or DBP ≥ 90mmHg on two occasions
* BMI 25 - 40 kg/m2
* Waist circumference ≥ 88 cm (women) or ≥ 102 cm (men)
* Sedentary lifestyle (\< 150 minutes/week of moderate intensity physical activity)
* Weight stable (± 5 kg in the last 6 months)
* Not on a weight loss diet
* Willing to comply to an intervention of either a hypocaloric Mediterranean diet or physical activity (or control) for 6 months

Exclusion Criteria:

* Unable to provide informed consent
* Pregnant or lactating
* Office BP ≥ 160/100 mmHg
* Diabetes mellitus type 1
* History of cardiovascular disease (including uncompensated heart failure, recent infarction or stroke in the last 6 months, severe arrhythmia, heart failure or unstable angina pectoris)
* Chronic kidney disease stages 4 or 5
* Cancer in the last 5 years
* Changes in concurrent medication (anti-hypertensives, anti-diabetics, lipid-lowering drugs) in the last 3 months
* Regular use of oral corticosteroids in excess of 5 mg prednisolone (or equivalent) during the last month
* Use of GLP-1 analogues for \< 1 year
* Drug or alcohol abuse
* Eating disorders or severe dietary restrictions
* Impediments to physical activity at recommended levels due to musculoskeletal and other conditions.
St. John's Wort Extract LI 160 for the Treatment of Atypical Depression

The aim of tis study is to assess the efficacy and safety of Jarsin® 300 mg as an acute treatment in mild to moderate depression with atypical features.

The general picture of depression is still that of the traditionally called endogenous type, which is also the form that was characterized extensively in clinical trials. Atypical depression with reversed vegetative signs, such as hyperphagia or hypersomnia, is traditionalla neglected, demonstrated by the fact that in the most widely used depression scales, such as the Hamilton Depression Scale, melancholic symptoms have a specific weight, while, by contrast, reversed vegetative signs are not included. This etablishes a tendency to underestimate the severity of atypical depression.

Eligibility Criteria:
Main Inclusion Criteria:

* Mild to moderate depression (ICD-10 F32.0, F32.1) with atypical features according to DSM-IV, lasting at least 3 months
* Female and male Caucasians aged 18 to 70 years
* At least one of HAMD-28 scale items 22-26 scores \>1
Study of a Smartphone-Based Alcohol Reduction Program

Prospective, open label, single center clinical study enrolling up to 100 adult participants to evaluate the feasibility, acceptability, and preliminary outcomes of the Pivot Clear smartphone-based alcohol reduction program.

This is a prospective, open label, single center clinical study conducted with institutional review board (IRB) approval enrolling up to 100 adult participants who report at-risk alcohol consumption behavior and would like to reduce or eliminate alcohol consumption. The study will be performed remotely on an ambulatory basis. Participants will be asked to set up and use the Pivot Clear program. The program includes an app, personal breathalyzer, and short message service (SMS) text-based coaching with an alcohol reduction specialist. The study duration is 52 weeks. While participants will have access to the program for 52 weeks, it is expected that for most participants, most active participation in the program will be complete by 12 weeks. The primary reporting time point will be 12 weeks, with expected passive, longer-term follow-up outcomes collected at 26 weeks and 52 weeks. Participants will receive online questionnaires at intervals throughout the study (baseline, weekly for the first 12 weeks, at 26 weeks and at 52 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Score of ≥ 3 for women and ≥ 4 for men on the AUDIT-C at screening
* Would like to reduce or eliminate alcohol consumption
* Resident of the United States
* Able to read and comprehend English
* Owns and uses a smartphone compatible with the study app (iPhone 6 and above, operating system iOS (iPhone operating system) 15 and above, or Android 7.0 and above, operating system Android 7.0 and above)
* Has daily internet access on smartphone
* Comfortable downloading and using smartphone apps
* Interested in working with an alcohol reduction coach via SMS text
* Willing to sign the Informed Consent Form (ICF)

Exclusion Criteria:

* Currently using other support to reduce or quit alcohol, including apps, coaching, support groups, classes or quit programs
* Pregnant (self-reported)
* Self-reported past or present diagnosis of Alcohol Use Disorder (AUD)
* Self-reported past or present diagnosis of Substance Use Disorder
* Current use of the following medications: suboxone, methadone, or daily use of a benzodiazepine \[including Alprazolam (e.g., Xanax), lorazepam (e.g., Ativan), clonazepam (e.g., Klonopin), diazepam (e.g., Valium), and temazepam (e.g., Restoril)\]
* History of hospitalization or in-patient treatment due to alcohol use
* Using other alcohol reduction or abstinence apps, coaching, support groups, classes, or programs at study entry
* Failure to provide contact or collateral information, and/or failure to verify email address
* Participation in a previous study sponsored by Pivot Health Technologies, Inc. (formerly Carrot Inc.)
Efficacy of Guided Biofilm Therapy (GBT) for Treatment of Deep Periodontal Pockets.

the aim of the study is to evaluate the efficacy of guided biofilm therapy (GBT) for treatment of deep periodontal pockets.

the objectives are

1- To compare the change in the clinical periodontal parameters and microbiological parameters by using real time PCR for P. gingivalis, Aggregatibacter actinomycetemcomitans and Filifactor alocis among sites treated by GBT and conventional hand instrumentation after a period of 3 months and to assess the level of the selected periodontal pathogens in deep periodontal pockets and to estimate and compare deep periodontal pockets which need surgery after 3 months of non-surgical treatment by GBT and conventional hand instrumentation.

the hypothesis is whether there are no differences in in the clinical and microbiological parameters among sites treated by GBT and conventional hand instrumentation after a period of 3 months or there are differences in in the clinical and microbiological parameters among sites treated by GBT and conventional hand instrumentation after a period of 3 months.

The participants will be selected on a consecutive basis from patients referred to the Department of Periodontics, College of Dentistry, University of Baghdad.

For each patient, each site will be randomly assigned to either treatment protocol:

1. Sites treated with GBT.
2. Sites treated with conventional manual instrumentation only.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients, aged more than 18 years.
2. No history of any systemic diseases.
3. Diagnosed with Stages 3 and 4 periodontitis according to the 2017 World Workshop on the Classification of Periodontal disease.
4. The presence of deep periodontal pocket ≥ 6 mm in two non-adjacent teeth.

Exclusion Criteria:

1. Smokers.
2. Pregnant and lactating mothers.
3. History of any previous subgingival instrumentation in the last 3 months.
4. The use of antibiotics/non-steroidal anti-inflammatory drugs in the last 3 months.
5. Regular use of medication to control systemic illness.
6. The presence of perio-endo lesion.
CytoSorb in Patients With Liver Failure

Hemoadsorption has been demonstrated to improve liver functional tests in patients with liver failure. The present study investigates the effects of three consecutive sessions of hemoadsorption, performed in accordance to the local protocol for treating patients with acute liver failure, on liver functional tests, severity scores and 30-days mortality. Paraclinical results and severity scores were obtained before and after the three consecutive sessions.


Eligibility Criteria:
Inclusion Criteria:

* patients with acute liver failure or acute on chronic liver failure who require hemoadsorption in accordance with local guidelines

Exclusion Criteria:

* unsigned informed consent
* duration of therapy under 12 hours
* death before the three consecutive sessions
Colloid Preload Versus Colloid Coload During Cesarean Deliveries

The investigators aimed to compare the methods colloid preloading and colloid coloading in terms of the incidence of maternal hypotension and impacts on neonatal outcomes. The second aim while planning the present study is to identify the method of the lowest adverse event for mother and infant and the simplest approach for the clinician.

Spinal anesthesia (SA) is currently the most preferred method of anesthesia in elective cesarean deliveries. However, SA causes maternal hypotension by decreasing systemic vascular resistance over sympathetic blockade. Maternal hypotension can lead to serious adverse events both in mother and in fetus: fetal hypoxia and acidosis occur due to decreased uterine blood flow, whereas the mother may experience vertigo, nausea, vomiting, alteration in consciousness, cardiovascular collapse and arrest. Today, various strategies have been suggested for the prevention of maternal hypotension. Of these strategies, the most critical ones are fluid load before spinal anesthesia (preloading) or rapid fluid load just after spinal anesthesia (coloading) and the use of vasopressor agent. The fluids used for this purpose include crystalloids and colloids. Comparative studies performed with colloid preloading, colloid coloading and crystalloid coloading indicated that the incidence of hypotension decreased similarly with no significant difference determined between the methods of fluid loading. Researchers defended necessity of using vasopressor agent together with fluid loading methods. In daily routine; however, the investigators observe that the incidence of hypotension is lower in the patients that undergo colloid preloading as compared to the patients that undergo colloid coloading or crystalloid coloading. The investigators therefore aimed to compare the methods colloid preloading and colloid coloading in terms of the incidence of maternal hypotension and impacts on neonatal outcomes. In the present study, the investigators aimed to use 6% HES 130/0.4 (Voluven ®), which is the newer generation colloid solution. The other aim while planning the present study is to identify the method of the lowest adverse event for mother and infant and the simplest approach for the clinician.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Singleton pregnancy
* Gestational age ≥ 37 weeks
* Height ≥ 150 cm and ≤ 180 cm
* Weight \> 50 kg and \< 100 kg

Exclusion Criteria:

* Gestational age \> 37 weeks
* Multiple pregnancies
* Fetal distress
* Preeclampsia
* Cardiovascular disease and diabetes
* Hematological problems
* Local infection at intervention site
* Abnormal coagulation tests
* Anticoagulant use
* Starch allergy
* Height \< 150 cm and \> 180 cm
* Weight \< 50 kg and \> 100 kg
HIRREM Hot Flashes Study

The purpose of this research study is to determine the effects of a technique called High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®), for women in any stage of menopause, who are experiencing menopause-related hot flashes.

The purpose of this research study is to determine the effects of a technique called High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®), for hot flashes. HIRREM uses scalp sensors to monitor brain electrical activity, and computer software algorithms translate selected brain frequencies into audible tones in real time. Those tones are reflected back to participants via ear buds in as little as four to eight milliseconds, providing the brain an opportunity for self-adjustment of its electrical pattern.

This study will compare acoustic stimulation linked to brainwave activity (HIRREM, along with continued current care, HCC), with continued current clinical care alone (CCC). Both groups will continue their other current care throughout, including non-pharmacological, and lifestyle modification therapies.

Eligibility Criteria:
Inclusion Criteria:

* Women, age 40 and above
* Intact uterus and ovaries
* Have at least 5 hot flashes per day (with at least one being categorized as moderate to severe, in a stable pattern for one month).

Exclusion Criteria:

* Less than 5 hot flashes per day
* Does not experience at least 1 moderate to severe hot flash per day
* Unable, unwilling, or incompetent to provide informed consent
* Physically unable to come to the study visits, or to sit comfortably in a chair for up to two hours
* Known seizure disorder
* Known or potential pregnancy (females with last menstrual period less than one year from enrollment will be tested for pregnancy prior to randomization)
* Severe hearing impairment (because the subject will be using headphones during the interventions)
* Ongoing need for treatment with opiate, benzodiazepine, or anti-psychotic medications, anti-depressant medications such as SSRI, SNRI, or tricyclic, and sleep medications such as zolpidem or eszopiclone
* Use of pharmaceuticals for treatment of vasomotor symptoms or any type of hormone replacement therapy
* Use of supplements for improvement of vasomotor symptoms including but not limited to black cohosh, soy isoflavone extract, and red clover leaf extract
* Menopausal symptoms resulting from, or associated with surgery, chemotherapy, radiation, or use of other chemicals or medications
* Anticipated and ongoing use of recreational drugs, alcohol, or energy drinks
* Ongoing need for treatment with thyroid medications
* Weight is over the chair limit (285 pounds)
* Are enrolled in another research study that includes an active intervention
* Have previously received brainwave optimization (BWO), used a B2 or a B2v2 wearable device, or previously participated in a HIRREM research study