cyrilzakka/clinical-trials huggingface dataset:
Safety of Gastric Volume Emptying After the Intake of Maltodextrin and Glutamine

Carbohydrates (CHO)-based drinks 2h before the induction of anesthesia are recommended to decrease insulin resistance. The addition of glutamine (GLN) in these beverages may enhance the benefits of CHO alone. However, only a few studies tested the safety of this formula. The objective of this study was to evaluate the gastric residual volume (GRV) after the intake of a beverage containing CHO plus GLN using magnetic resonance (MRI).

We included 11 male young volunteers (aged between 21 and 30 years-old) with body mass index (BMI) between 20 and 29 kg/m2 and without either acute or chronic illness in the last 3 months. The criteria for exclusion were non-adherence to any phase of the study protocol, gastroesophageal reflux disease, previous history of intolerance to lactose, gastroparesis or history of poor gastric emptying, diabetes mellitus, and previous abdominal surgery.

Each volunteer was randomized for participation in the study in a blind fashion. All subjects underwent two different protocols before MRI with an interval of seven days between them. Both phases took place after an overnight fast of eight hours. The volunteers ingested 400ml (4 hours before the exam was carried out) at 8:00AM and 200ml (2 hours before the exam was carried out) at 10:00AM of a beverage containing either water plus 12.5% maltodextrin (Phloraceae, Cuiabá, Brazil; CHO group) or the same beverage plus 15g of GLN (Phloraceae, Cuiabá, Brazil; GLN group). The participants were instructed not to ingest alcohol, medication, and caffeine within 24 hours of the study, nor do any vigorous physical activity during that time.

In both phases the individuals were blind to the specific drink and they were told to ingest the beverage in a maximum period of five minutes and T0 was defined as the moment they complete the intake of the solution.The powdered products (maltodextrin alone or maltodextrine plus glutamine) were packed in coded opaque sachets and the content was only known by the pharmacist who manipulated it.

All the participants in the study underwent magnetic resonance of the upper abdomen at 12:00AM and 01:00PM. The GRV observed during the first exam was defined as T120 and the second exam as T180. All exams were performed by the same magnetic resonance equipment (Intera 1.5T ; Philips Healthcare, Eindhoven, Holland).

Eligibility Criteria:
Inclusion Criteria:

* Young male volunteers (aged between 21 and 30 years-old) with body mass index (BMI) between 20 and 29 kg/m2 and without either acute or chronic illness in the last 3 months.

Exclusion Criteria:

* non-adherence to any phase of the study protocol,
* gastroesophageal reflux disease,
* previous history of intolerance to lactose,
* gastroparesis or history of poor gastric emptying,
* diabetes mellitus, and
* previous abdominal surgery
Extension Connection Evaluation

This study will perform a retrospective analysis to evaluate the effectiveness of a multicomponent educational intervention to improve medication use and management of behavioral and psychological symptoms of dementia, relative to a statewide intervention that has been ongoing. Medication use and symptom severity outcomes will be compared among intervention counties and demographically similar non-intervention counties.

This study will perform a retrospective analysis to evaluate the effectiveness of a multicomponent educational intervention to improve medication use and management of behavioral and psychological symptoms of dementia, relative to a statewide intervention that has been ongoing. Medication use and symptom severity outcomes will be compared among 29 intervention counties and 10 demographically similar non-intervention counties. The long-term effectiveness of the statewide intervention will also be evaluated. Medicare and Minimum Data set data from 2011 to 2014 will be used to evaluate prescribing and other outcomes in 1) outpatients with dementia, and 2) nursing home residents, based on exposure to interventions among healthcare and nursing home providers. Measurable goals included increasing the appropriateness of antipsychotic prescribing and reducing anticholinergic use. Effect modification will be evaluated by level of participation in the intervention and other prescriber and nursing home facility characteristics.

Eligibility Criteria:
Inclusion Criteria:

1. Current Medicare fee-for-service plan and Part D enrollment for at least 3 months prior to the month of interest and during the month of interest (allowing a gap of one month to be considered as continuous enrollment if the person is enrolled during the month of interest)
2. Age greater than or equal to 66 years at the end of a year of interest
3. Any dementia diagnosis prior to the month of interest, or current resident of a nursing home
4. For the nursing home analysis, at least 14 days in the facility in the month being classified

Exclusion Criteria:

1. Greater than 15 days of the month of interest when prescription fills are unobservable from Medicare Part D claims due to hospital inpatient status, skilled nursing facility resident status, or hospice enrollment
2. A diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, Huntington's disease, Down's syndrome, or mental retardation or developmental disability at any time during the study period. Diagnoses after entry into the study sample will be included because of the limited look-back period to define some conditions for some individuals, and because these are generally not conditions with late-life onset so they are assumed to have been present prior to the first occurrence of a diagnosis in the available data
3. Currently comatose based on the most recent MDS assessment-if currently in a nursing home
A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sjögren's Syndrome

The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Primary Sjögren's Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily signed informed consent ;
* Patient with primary Sjögren's syndrome according to the European - American consensus group criteria.
* Seropositive at screening for anti-Ro/Sjögren's syndrome type A(SSA) antibodies
* ESSDAI score ≥ 5.

Exclusion Criteria:

* Diagnosis of secondary Sjogren's syndrome, such as rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis and other autoimmune diseases;
* Abnormal laboratory parameters need to be excluded, including but not limited to:
* Immunosuppressive agents were used within 4 weeks prior to randomization.;
* The use of hydroxychloroquine was allowed during the trial, and the pre-randomized drug regimen was stable for less than 12 weeks;
* Use of biological agents for targeted therapy in the first 6 months of randomization;
* Treatment of primary Sjogren's syndrome with traditional Chinese medicine and proprietary Chinese medicine within 4 weeks before randomization;
* The use of saliva-stimulating drugs within 7 days prior to randomization;
* Sodium hyaluronate eye drops, artificial tears can be used, and the stability time of the randomized pre-medication scheme is less than 4 weeks;
* Intravenous immunoglobulin therapy or plasma exchange therapy within 6 months before randomization;
* Infection with herpes zoster or HIV and hepatitis C virus(HCV) antibody positive;
* Currently suffering from active hepatitis or severe liver lesions and history;
* Malignant tumor patients ;
* Combined with involvement of important organs or neuropathy;
* Have participated in any clinical trial in the first 28 days of the initial screening or 5 times half-life period of the study compound (taking the time for the shorter).
* Pregnant , lactating women and men or women who have birth plans during the research;
* Investigator considers candidates not appropriating for the study
Bowel Function After Laparoscopic Colon Surgery: Effect of IV Lidocaine

Patients receiving perioperative intravenous lidocaine, post operative restoration of bowel movement will be faster and decrease pain intensity, opioid consumption and side effects, length of hospital stay; probably as a result of a significant opioid sparing and attenuated inflammatory response.

The aim of this study is to assess whether perioperative intravenous lidocaine has an impact on the early postoperative physical activity recovery of patients scheduled for laparoscopic colorectal resection.

The study focuses on patients with colorectal disease, which receive the laparoscopic (assisted) surgical approach.

It is hypothesized that in those patients receiving perioperative and post-operative intravenous lidocaine, bowel function recovery will be faster, probably as a result of a significant opioid sparing, less pain and attenuated inflammatory response.

Eligibility Criteria:
Inclusion Criteria:

* scheduled to undergo laparoscopic colorectal resection

Exclusion Criteria:

* patients who have trouble to understand, read or communicate either in French or in English
* dementia
* patients suffering from severe physical disability (arthritis, neuromuscular dysfunction, stroke, paraplegia) or inability to walk or conduct daily activity
* patients suffering from severe cardiac or respiratory disease (status ASA IV
* patients suffering from metastatic carcinoma
* patients who have a history of chemoradiation within the six months preceding surgery
* allergy to lidocaine
* morbid obesity
* patients with chronic opioid use.
Alpha-1 Blockade for Alcohol Use Disorder (AUD)

The goal of this research is to replicate findings previously conducted in a pilot trial and to understand, mechanistically, the role of stress in the development of AUD pharmacotherapies that target noradrenergic blockade.

16 week, between-subject, double-blind, randomized clinical trial (RCT) with doxazosin (16 mg, or maximum tolerated dose, MTD) compared to placebo in 184 treatment seeking individuals with AUD

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age
* Meet the DSM-5 criteria for AUD
* Desire to reduce or quit alcohol drinking
* Breath alcohol (BrAC) = 0.00 at each visit
* In good health as confirmed by medical history, physical examination and lab tests
* Willing to adhere to the study procedures
* Understand informed consent and questionnaires in English at an 8th grade level

Exclusion Criteria:

* Women who are breastfeeding or /positive urine test for pregnancy
* CrCl\<60mL/min
* Suicide attempt in the last three months
* Current diagnosis of other substance disorder other than nicotine as assessed by self-report and urine toxicology screen at baseline
* Current use of medication that may interact with doxazosin and/or yohimbine
* History of allergy to any alpha receptor blockers
* Clinical Institute Withdrawal Assessment for Alcohol revised (CIWA-Ar) score ≥ 8
* Treatment with disulfiram, naltrexone, acamprosate, topiramate within 1 month prior to screening
* Treatment with any alpha-blocker
* Individuals with cardiac heat failure (CHF), as assessed by the medical history, the physical exam and the ECG.
* Baseline hypotension defined as BP reading lower than 90/60 mmHg
* Use of phosphodiesterase inhibitors (PDE5) erectile dysfunction medication
Umbilical Cord Blood Transfusion in Progeria Syndrome

This is a pilot study on safety and efficacy of umbilical cord blood therapy for patients with Hutchinson Gilford Progeria syndrome (HGPS). This is an 1 year trial with 3 IV infusions (4 months apart from each infusion) of umbilical cord blood units with oral Sirolimus to see the safety and efficacy.

This is a pilot study on safety and efficacy of umbilical cord blood therapy for patients with Hutchinson Gilford Progeria syndrome (HGPS). HGPS is a rare genetic disease where affected LMNA gene coding lamin A protein leads to premature aging and early death.

Teenagers with HGPS are in high risk of atherosclerosis and ischemic stroke, and these are major reason of mortality in HGPS.Currently, there are no definite cure for this rare genetic disease. Among the potential drugs under investigation, Lornafarnib (farnesyltransferase inhibitor) lowered the carotid-femoral pulse wave velocity (cfPWV) and also lowered mortality.

Stem cell therapy has proven its efficacy in progeria mouse model. We are trying to study safety and efficacy of umbilical cord blood therapy in human HGPS patients.

Eligibility Criteria:
This is a pilot study including 2 patients with HGPS.

Inclusion Criteria:

* those who were clinically and genetically diagnosed as Hutchinson-Gilford progeria syndrome

Exclusion Criteria:

* those who show definite hemorrhage or ischemia on brain MRI
* those who are affected with systemic infection during study enrolling period
* those who are not able to able to make consents to the study; those who are not accompanying any guardians
* those who were enrolled in other clinical trials within last 30 days
* those who are not appropriate according to laboratory criteria

  1. whose ALT/AST \> 2 fold of normal limit
  2. whose serum creatinine \> 1.5 fold of normal limit
  3. whose total bilirubin \> 2 fold of normal limit
  4. whose total WBC count \< 3000/mm3
  5. whose platelet count \< normal lower limit
* those who are diagnosed with other malignancies
* those who are affected by other serious medical (cardiopulmonary, gastrointestinal, endocrinologic, etc.) conditions
Evaluation of Deposits on Contact Lenses Worn Daily Wear

The purpose of this study was to measure front surface deposits on contact lenses when worn for ten hours.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older.
* Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses.
* Successfully wearing hydrogel or silicone hydrogel contact lenses prior to enrollment in the study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Evidence or history of keratitis (dendritic keratitis); viral disease of the cornea and/or conjunctiva; acute bacterial disease of the cornea and/or conjunctiva and/or eyelids; infection of the eye; and/or fungal disease of the eye.
* One functional eye or a monofit lens.
* Ocular conditions such as active acute blepharitis, conjunctival infections, and iritis.
* Any slit-lamp finding score of (1) at the Screening Visit as defined in protocol.
* Use of concomitant topical ocular prescription or over-the-counter (OTC) ocular medications.
* History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear.
* Other protocol-defined exclusion criteria may apply.
Zinc, Iron, Vitamin A and Psychosocial Care for Child Growth and Development

Many Indonesian infants are already iron deficient before they reach the age of six months, which also determines the high prevalence of anemia among under-five children. Iron deficiency ultimately leads to anemia, and there is clear evidence that iron deficiency anemia during early childhood has a marked negative effect on child development and cognitive function (Lozoff et al.1991; Idjradinata \& Pollitt, 1993). This negative impact on childhood development is one of the main reasons why iron deficiency during infancy should be prevented or treated.

Since diets low in iron is usually also low in zinc, zinc deficiency --which has negative consequence on growth-- is common in iron deficiency area. In Southeast Asia, the condition is exacerbated by the rich phytate content in the complementary foods which inhibits the absorption of iron as well as zinc (Gibson, 1994). Thus, combining both iron and zinc, hence, is expected to decrease both iron and zinc deficiencies and hence improve growth and development of the children.

Recently, there has been an emerging view which looks at the two-way relationship between nutrition, health, and psychosocial well-being. This concept is supported by studies on "positive deviance", a term used to refer to children who grow and develop well in impoverished environments where most children are victims of malnutrition and chronic illness (Zeitlin et al., 1990). The mechanism which helps to explain how psychosocial factors, such as the affect between mother and child, are associated with adequate growth and development: 'Psychological stress has a negative effect on the use of nutrients whereas psychological well-being stimulates the secretion of growth-promoting hormones. Pleasantly stimulating interactions can enhance the child's tendency to exercise its developing organ systems and hence to utilize nutrients for growth and development'.

Understanding how the psychosocial environment can promote or inhibit the benefit of supplementation intervention is necessary in order to have a better way of setting about providing supplements. In fact, many supplementation programs do not incorporate complementary program elements that would help to improve the health and psychosocial development of children at the same time that they improve nutritional status' (Myers, 1995). Looking from this perspective, not only will supplementation benefit the psychosocial development but also the psychosocial environment can promote the benefit of the supplementation on the nutritional status and developmental outcomes of infants.

The purpose of the study is to investigate whether multi-micronutrient supplementations (zinc+iron, zinc+iron+vit.A) have positive effect on infants' growth and developmental outcomes, and whether the effect is modified by psychosocial care.


Eligibility Criteria:
Inclusion Criteria:

* 3 to 6 month old
* predominantly breast-fed children (assuming the infants were already introduced complementary feedings as early as 4 months)
* parental consent

Exclusion Criteria:

* apparent congenital abnormalities
Comparison Of Different Doses Of Intrathecal Neostigmine In Prevention Of Post-Dural Puncture Headache

We hypothesized that; intrathecal administration of neostgmine in spinal anesthesia may have a beneficial role in reduction of the incidence or severity of PDPH.

Neostigmine will be administered in two different doses (10 \& 20 mic) in addition to 10mg bupivicaine intrathecally for cesarean section compared to control group where 10 mg bupivicaine in addition to 20mic fentanyl will be administered intrathecally. The primary outcome will be detection of the incidence of postdural puncture headache (PDPH). A 25-gauge Quincke spinal needle will be used for spinal anesthesia.Patients indicated for elective caesarean section surgery will be included in the study. The exclusion criteria are contraindications for regional anesthesia including local infection, hemorrhagic disorders, drug hypersensitivity, muscular disorders and central and peripheral neuropathy, and drug abuse history and addiction.

Other outcomes will include age, ASA class, and duration of surgery. Sensory and motor function will be assessed every minute until T4 level is reached. Hemodynamic status (systolic and diastolic blood pressures, heart rate, and SPO2) will be recorded every 3 minutes throughout the surgery and then 4 hourly thereafter, for 24 h postoperatively. Recovery time from spinal anesthesia (return of motor power of both lower limbs) will be also recorded by anesthesiologist who is unaware of the group. Also the intra-operative and recovery phase complications including nausea, vomiting, itching, dyspnea, respiratory rate less than 10 per min, hypoxia (SPO2 less than 92% on room air), bradycardia (HR less than 60bpm), and hypotension (SPB less than 90) will be recorded.

Postoperative assessment will include pain scores "Overall 24-h VAS score", recorded at 30-min interval for first 4 h and then 4 hourly thereafter, for 24 h postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients indicated for elective caesarean section surgery

Exclusion Criteria:

* Contraindications for regional anesthesia including local infection, hemorrhagic disorders, drug hypersensitivity, muscular disorders and central and peripheral neuropathy, and drug abuse history and addiction.
Prevalence of Post-traumatic Stress Disorder and Trauma Symptoms in a General Population Sample

The goal of this observational study is to learn about how many people have post-traumatic stress disorder and related symptoms in the general population of people without any mental illness in the Barcelona region of Catalonia, Spain. The main questions it aims to answer are:

* What is the prevalence of post-traumatic stress disorder in a sample of healthy controls without other mental disorders?
* What is the prevalence of trauma-related symptoms in a sample of healthy controls without mental illness?
* What is the prevalence of dissociative symptoms (including symptoms of depersonalisation and somatoform dissociation) in a sample of healthy controls without mental illness?
* What is the prevalence of recent and childhood traumatic life events in a sample of healthy controls without mental illness?
* What is the prevalence of difficulties in psychosocial functioning in healthy controls without mental illness?
* What is the prevalence of depressive symptoms in healthy controls without mental illness?
* What is the prevalence of general psychiatric symptoms in healthy controls without mental illness? Participants will be asked to take part in an online screening programme, and then to come to an interview with a clinician who will apply validated scales to test the above.

This is a study to provide normative data for the prevalence of traumatic life events, post-traumatic stress disorder and trauma-related symptoms, and their impact on psychosocial functioning, and affective symptoms in healthy controls (i.e. without mental illness) in the Barcelona region of Catalonia, Spain.

Eligibility Criteria:
Inclusion Criteria:

* to be an adult (18-65 years inclusive)

Exclusion Criteria:

* to have a mental disorder except for post-traumatic stress disorder, determined by application of the Mini International Neuropsychiatric Interview (MINI)
* active suicidal ideation
* presence of organic brain disease
* presence of somatic diseases such as fibromyalgia or chronic fatigue syndrome
* presence of autoimmune diseases such as HIV or AIDS