cyrilzakka/clinical-trials huggingface dataset:
Does Preventive Analgesia Improve the Outcome of Demerol-Vistaril Procedural Sedations in Pediatric Dentistry

All healthcare providers strive continually to improve the outcome of their treatment approaches. The investigators hypothesize that preventive analgesics administered before a child is sedated with a Demerol-Vistaril regimen will improve the outcome of a sedation.

To increase outcomes for patients receiving dental sedation by providing significant evidence that the new regimen improves the quality of sedation and results in an improved post sedation ability to eat, drink, resume normal activities and require less additional pain medications.

Eligibility Criteria:
Inclusion Criteria:

* We intend to enroll 300 children between the ages of 2 - 8 years of all ethnicities for this prospective, placebo controlled, randomized, and double-blind trial. All children that fulfill our general selection criteria for this sedation regimen will be eligible for this study.

Exclusion Criteria:

* Children who do not meet our general selection criteria for this sedation regimen will be ineligible for this study.
Study of INT-747 in Patients With Diabetes and Presumed NAFLD

The primary objectives of this study are to assess, in patients with Type 2 diabetes mellitus (DM) and presumed nonalcoholic fatty liver disease (NAFLD), the following:

* The safety and tolerability of multiple doses of INT 747;
* The effects of 2 dose levels (25 mg and 50 mg) of INT 747 on insulin resistance and glucose homeostasis;
* Effects of INT-747 on hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function and inflammation, and;
* Trough concentrations of INT-747 and its metabolites, glyco 6-ethyl chenodeoxycholic acid (6-EDCA) and tauro 6-ECDCA.

This is a multi-center, double-blind, randomized, placebo-controlled, multiple-dose, parallel-group study. Three (3) cohorts of 12 patients each will receive either placebo, 25 mg INT-747, or 50 mg INT-747 by mouth daily for 6 weeks.

The primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the end of 6 weeks of treatment (Day 43). Other endpoints will be evaluated by monitoring adverse experiences; vital signs; clinical laboratory values; plasma drug and metabolite concentrations; and general health and well-being.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes, defined by the American Diabetes Association (ADA), as one of the following criteria:
* Symptoms of diabetes plus casual plasma glucose concentration \>200 mg/dL (11.1 mmol/L) or
* Fasting plasma glucose \>126 mg/dL (7.0 mmol/L) or
* 2-hour post-load glucose \>200 mg/dL (11.1 mmol/L) during a 75 g oral glucose tolerance test (GTT).
* Presumed NAFLD, defined by one of the following criteria:
* Alanine aminotransferase (ALT) ≥47 U/L for females and ≥56 U/L for males
* Aspartate aminotransferase (AST) ≥47 U/L for females and ≥60 U/L for males
* Enlarged liver (demonstrated by ultrasound or other imaging technique)
* Diagnostic histological findings shown on prior biopsy (in the last 5 years).

Exclusion Criteria:

* Bilirubin \>2 × ULN
* ALT \>155 U/L for females and \>185 U/L for males.
* AST \>155 U/L for females and \>200 U/L for males.
* Patients taking any antidiabetic medications, with the exception of metformin and sulfonylureas. If the HbA1c is \<11%, patients may be enrolled who have been withdrawn from all other diabetic medications as specified in the protocol, at the discretion of the Principal Investigator.
Preoxygenation Using High Flow Oxygen : Efficacy and Tolerance in Healthy Volunteers

High flow nasal cannula oxygen has been proposed to perform preoxygenation in patients with acute respiratory failure requiring orotracheal intubation in intensive care units. However, its use for preoxygenation before the induction of general anaesthesia in operating room has never been evaluated in term of end tidal oxygen fraction which is the gold standard measurement during preoxygenation before general anaesthesia.

The goal of the present study is to measure end tidal oxygen after 3 min of preoxygenation using the recommended method (spontaneous breathing of 100% inhaled oxygen through a face mask) and using high flow nasal canula oxygen, in healthy volunteers.

High flow nasal cannula oxygen has been proposed to perform preoxygenation in patients with acute respiratory failure requiring orotracheal intubation in intensive care units. The results suggest that high flow oxygen could be superior to bag reservoir face mask in term of occurrence of severe hypoxemia during the intubation procedure.

At the present time its use for preoxygenation before the induction of general anaesthesia in operating room has never been evaluated in term of end tidal oxygen fraction which is the gold standard measurement ensuring that the functional residual capacity has been filled with oxygen.

We planned a randomised cross over study in healthy volunteers studying efficacy and tolerance of preoxygenation using spontaneous ventilation with 100% inhaled oxygen through a face mask connected to the anaesthesia machine and preoxygenation using high flow nasal cannula oxygen (60l/min).

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers,
* signed contentment

Exclusion Criteria:

* any chronic or acute disease,
* pregnancy
The Effect of Pregnancy on Temporal Summation and Venipuncture Pain Perception

Recent studies have shown that women are more likely to experience pain in many medical situations. During pregnancy, women may experience an increase in pain threshold. This is thought to be related to hormonal changes and an increase in the level of certain natural pain-relieving substances in their bodies.

It is important to develop simple tests to identify woman at higher risk for pain so the investigators can help them.

Temporal summation is what happens when a person becomes more sensitive to a certain feeling on their skin when it is applied several times over the course of several seconds. The investigators hypothesize that pregnant women show decreased temporal summation and pain scores to venipuncture, compared to non-pregnant women.

Recent epidemiologic studies have shown that women are at substantially greater risk for many clinical pain conditions, and there is a suggestion that postoperative and procedural pain may be more severe among women then men. During pregnancy, women experience an elevation in the threshold to pain and discomfort. In addition to hormonal changes, the changes in pain perception during pregnancy may be related to an increase in endogenous opioids.

Pain is the most feared experience in the intra and postpartum period, and severe pain experienced during this time can lead to significant morbidity, including chronic pain and depression. Much attention has been paid to tests that can predict patients at higher risk for pain. Temporal summation (TS) has been shown to be a simple and reliable test. Temporal summation represents the physiological wind-up phenomenon taking place at the spinal level of the central pain pathways. TS extent can be measured in humans by administering a series of noxious stimuli of constant intensity and of various modalities in order to evoke an increase in perceived pain. It is a very simple and easy test to perform, and very well tolerated by patients. Whether TS changes in pregnancy and whether TS in pregnancy correlates with pain perception during acute stimuli such as venipuncture is unknown.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* able to communicate in English
* healthy pregnant patients in the 1st, 2nd and 3rd trimesters
* healthy non-pregnant patients

Exclusion Criteria:

* refusal to participate
* Patients under age 18 or over age 40
* Inability to communicate in English
* Use of analgesics, anti-depressants and muscle relaxants
* self-report of substance abuse
* previous injury to the non-dominant arm/forearm
The Effects of the Female Hormones on Cerebral Perfusion

Measuring brain perfusion is biased by a inter- and intrasubject variability, caused by physiological and lifestyle factors. In this study, the investigators want to investigate the variations in cerebral perfusion and other brain parameters (grey matter, resting-state brain activity, brain connectivity and white matter diffusion) caused by the female sex hormones and hormonal contraception.


Eligibility Criteria:
Inclusion Criteria:

* Bachelor or Master student
* Minimum of 3 months not using contraception of using Deso20

Exclusion Criteria:

* No informed consent
* MRI-contraindications
* Claustrophobia
* Pregnancy or breastfeeding
* Chronic diseases and chronic medication use
* Smoker
* Drug use
* Abuse of alcohol and caffeine
The Application of Balanced Propofol Sedation in Fiberoptic Bronchoscopy

The purpose of this study is to investigate the feasibility of using balanced propofol sedation for bronchoscopy. And screen out the optimal balanced propofol sedation compatibility plan.

Balanced propofol sedation (BPS) is a technique proposed and developed by gastroenterologists. In recent years, multiple studies have confirmed that the use of BPS in gastrointestinal endoscopy can not only ensure patient comfort, but also reduce the incidence of respiratory and circulatory suppression. Moreover, the postoperative recovery time is short. Even for non-anesthesiologists applying BPS in gastrointestinal endoscopy , it has high safety.

Compared with gastrointestinal endoscopy, bronchoscopy occupies the respiratory tract and most patients have respiratory system diseases. Therefore, it is more necessary for strict respiratory management and control of patient sedation depth. Traditional midazolam combined with opioid drugs or propofol monosedation cannot effectively meet clinical needs. The excellent sedative and analgesic effects of BPS, as well as its maintenance of respiratory and circulatory functions, make it theoretically very suitable for application in bronchoscopy. However, there is currently a lack of evidence to support the application of BPS in bronchoscopy.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists classes I-IV ;
2. Patients undergo painless bronchoscopy, including bronchoscopic biopsy (bronchoscopic lesion biopsy, bronchial mucosal biopsy, bronchoscopic transmural lung biopsy, bronchoscopic needle aspiration biopsy) ,bronchoalveolar lavage and bronchoscopic treatment;
3. Normal communication skills and able to cooperate in completing this study;
4. Patients who voluntarily accept this experimental study and sign the "Trial Informed Consent Form".

Exclusion Criteria:

1. Patients with contraindications or allergies to anesthesia;
2. Individuals with a history of alcoholism or drug abuse;
3. Patients with contraindications for puncture of the cricoid membrane;
4. Patients with mental or neurological disorders, taking anti anxiety/depression drugs, or primary diseases with laboratory evidence indicating possible changes in hormone levels;
5. Patients with difficulty in language communication, poor understanding ability, and inability to cooperate in completing experimental studies;
6. Patients who require laryngeal mask or tracheal intubation for assisted ventilation during the examination process;
7. Patients undergoing rigid bronchoscopy treatment;
8. Patients who refuse to receive sedation or have not signed the "Trial Informed Consent Form".
Asthma Self-Management in Older Adults

Asthma self-management is an effective way to improve the outcomes of patients with asthma. However, to be most effective these interventions should be targeted and designed toward a specific population or group. There is currently no asthma self-management intervention directed towards older adults. The hypothesis is that a 6-session asthma self-management intervention will improve the outcomes of older patients with asthma.


Eligibility Criteria:
Inclusion Criteria:: Age over 65, physician diagnosed asthma, need for daily asthma control medication, access to a telephone.

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Exclusion Criteria: Smoking history greater than 40 pack years, current smoker, mental impairment that would preclude participation in the asthma self management program

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Video Chat During Meals to Improve Nutritional Intake in Older Adults

The VideoDining study is a Stage IB behavioral intervention development project. The objectives are to determine the feasibility and acceptability of using video chat during mealtimes (VideoDining) in community-dwelling older adults eating alone at home and to evaluate changes in nutritional intake and loneliness in response to VideoDining.

The U.S. population is growing older and more adults are aging at home alone, by choice, or due to a lack of affordable senior housing. Older adults who live alone have a less healthy eating pattern, eat a smaller variety of foods and consume fewer fruits and vegetables than those living with others. Additionally, eating alone, social isolation and loneliness often accompany living alone and are independent risk factors for lower caloric intake, less variety in the diet and malnutrition. Community-based interventions are needed to improve the nutritional status of older adults living alone.

VideoDining uses video chat during mealtimes to virtually eat with another person and could provide social interactions and modeling to improve dietary intake in older adults eating alone. Extensive observational and experimental research shows that people eat more when dining with others than dining alone, called the social facilitation of eating. Additionally, a dining partner's modeling of eating can provide a guide for what and how much to eat. The investigators have conducted a Stage IA proof-of-concept study of VideoDining in older adults and will expand the development of this behavioral intervention with this study.

The goals are to determine the feasibility and acceptability of VideoDining and to evaluate changes in nutritional intake and loneliness in response to multiple VideoDining sessions in community-dwelling older adults eating alone at home. In this single-arm intervention study, thirty older adult Meals on Wheels participants will be scheduled to VideoDine with a dining partner six times. Using a mixed-methods approach, the investigators will collect data on older adults' ability to VideoDine, acceptance of VideoDining, dietary intake, and loneliness. Data will be collected before starting VideoDining, after each VideoDining session, and at the end of the study period. Development, adaptation and refinement of the VideoDining intervention are additional key outcomes of this study.

Eligibility Criteria:
Inclusion Criteria:

1. Receive Meals-on-Wheels meals from Foodnet in Tompkins County, NY.
2. Aged 60-95 years old.
3. Consume Meals-on-Wheels meal alone.

Exclusion Criteria:

1. Non-English speaking.
2. Unable to read and write in English.
3. Inadequate vision and hearing to utilize video chat technology.
4. Unable cognitively to independently consent and participate in the study.
5. Already own and use an Amazon Echo Show.
Differential Effectiveness of Robotic Assisted Therapy on Upper Extremity Function in Patients With Chronic Stroke

The objectives of this study are to: determine the effects of exoskeleton vs. end effector training systems on upper extremity motor and physiological function, daily functions, quality of life and self-efficacy in patients with chronic stroke.

According to the theory and literature review, there are two hypotheses in this study. One is that exoskeleton training system has better benefits than end-effector training system in motion control techniques, joint mobility and muscle tone control. Second, end-effector training system has better benefits than exoskeleton training system in the functional activity level and daily life participation.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Stroke more than 3 months.
* FMA score 29\~59.
* Modified Ashworth Scale proximal part ≤ 3, Modified Ashworth Scale distal part ≤ 2, and no serious muscle spasms.
* Mini Mental State Examination ≥ 24 and no serious cognitive impairment.
* Learn more about the research content and can provide informed consent.

Exclusion Criteria:

* Other neurological disease
* Inability to understand instructions
* current participation in any other research
* Botulinum Toxin injection within 3 months
Transversus Abdominis Plane (TAP) Block for Post Caesarian Pain

Adding TAP block with Bupivacaine may decrease the use of PCA bolus use after caesarean section for pain relief.

Participants in the study will be randomized to TAP block with 0.5% or 0.25% bupivacaine or with placebo (normal saline).

The number of PCA bolus used within 24 hours post cesarean section will be compared between the groups.

Eligibility Criteria:
Inclusion Criteria:

Healthy pregnant (ASA II) patients presenting for planned Cesarean delivery at New York Methodist Hospital under combined spinal epidural anesthesia

Exclusion Criteria:

* They are unable or are unwilling to take part in the study
* They have a history of allergy to any of the medications to be used in the study
* They have a history of drug abuse or chronic pain or opioid use
* They weigh less than 60kg
* They have a multiple gestation, placental disease, preeclampsia other disease of pregnancy
* They have a contraindication to neuraxial anesthesia (i.e., bleeding problems, bacteremia, etc.)
* They are unable to understand instructions or questions related to the study
* ASA III or IV
CREMS Prostate Biopsy Pain Relief Study

The current standard for pain relief during prostate biopsy is the injection of local anesthetic agents into or around the prostate at various sites including apex, base, lateral aspects and into the prostate itself. Despite such anesthetic injection, some men still experience severe pain and often at the base of the penis. The study audits current practices comparing the degree of pain relief provided by injection at basal versus basal+apical sites. All these injection sites are standard practice at our hospital.


Eligibility Criteria:
Inclusion Criteria:

* Men who come for prostate biopsy

Exclusion Criteria:

* Men who are unwilling or unable to consent and fill in the forms
Life Style Modifications Prevents Type 2 Diabetes in Asian Indians

Three year prospective randomised controlled trial in IGT subjects to study the effect of metformin and lifestyle modification in preventing the conversion to diabetes

Lifestyle modification helps in primary prevention of diabetes in multiethnic Americans, Finnish and Chinese populations. In a prospective community based study, we tested if the conversion to diabetes could be influenced by interventions in native Asian Indians with impaired glucose tolerance (IGT) who were younger, leaner and more insulin resistant than the above populations.

We randomized 531 (Men : Women, 421 : 110) subjects with IGT \[mean age of 45.9 + 5.7 years and body mass index (BMI) of 25.8 + 3.5 kg/m2 into four groups. Group 1 was the control (CON), Group 2 was advised lifestyle modification (LSM), Group 3 was treated with metformin (MET) and Group 4 with LSM plus MET. Primary outcome measure was type 2 diabetes diagnosed by the WHO criteria.

In a median follow up of 30 months, three year cumulative incidence of diabetes were 55.0%, 39.3%, 40.5% and 39.5% in group 1 to 4 respectively. The relative risk reduction was 28.5% with LSM (95 % confidence interval (CI), (20.5 - 37.3), (p=0.018), 26.4% with MET (95% CI, 19.1 - 35.1) (p = 0.029) and 28.2% with LSM plus MET (95% CI, 20.3 - 37.0), (P=0.022) versus control group. The numbers needed to treat to prevent one incident case of diabetes were 6.4 for LSM, 6.9 for MET and 6.5 for LSM+MET.

Conversion of IGT to diabetes is high in native Asian Indians. LSM and metformin significantly reduced the incidence of diabetes in Asian Indians with IGT. There was no added benefit by combining both.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female. 35 - 55 years. No Known history of diabetes. Willing and available for a three years study.

Exclusion Criteria:

* Pregnant women. Subjects with major illness such as cancer, hepatic or cardiac diseases. Tranferable jobs.
Overweight and Obesity in Relation to Type ll Diabetes Melitus

The aim of the study is to evaluate the efficacy of local Zambian food in improving metabolic profiles of overweight/obese type ll diabetic patients in Kitwe district


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients attending Kitwe Teaching Hospital
* 18 years and above
* Body Mass Index of 25 and above
* Willing to follow the diet plan and eat food provided
* Not enrolled in other clinical studies

Exclusion Criteria:

* Eating disorder or any psychosocial or scheduling factors that could impede study outcomes
* Have renal or liver problem
* Pregnant women
* Breast feeding women
* HIV positive individuals
Contrast Enhanced Ultrasound, Endoleak Detection Following EVAR v1.3

A single site cross-sectional comparison of paired diagnostic imaging modalities.

This study will show the sensitivity and specificity of CEUS in detecting the various types of endoleaks, in comparison to tCTA, following EVAR. It will collect data to allow comparison of diagnostic accuracy across modalities including CDU, CEUS and tCTA. It will collect time taken to perform the various types of scan, to allow healthcare costs to be calculated for each imaging modality.

This study will show the sensitivity and specificity of CEUS in detecting the various types of endoleaks, in comparison to tCTA, following EVAR. It will collect data to allow comparison of diagnostic accuracy across modalities including CDU, CEUS and tCTA. It will collect time taken to perform the various types of scan, to allow healthcare costs to be calculated for each imaging modality.

Collected data will be analysed regarding two novel hypothesised methods of using CEUS information:

The first is recording temporal delay between contrast in graft and contrast in endoleak to define endoleak type. Potentially this could be used as a faster method of defining endoleak type in a surveillance programme.

The second is to identify/refute correlation between CEUS contrast to appear in endoleak vs tCTA contrast to appear in endoleak. If an association can be established, CEUS timings could potentially then be used to time 'standard' CTA phases to improve CTAs diagnostic accuracy.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 or over
2. Able to give informed consent
3. Undergone an EVAR of infra-renal abdominal aortic aneurysm
4. Planned for CTA of EVAR

Exclusion Criteria:

1. Unable to receive CTA Contrast Allergy, Insufficient renal function for standard outpatient contrast study (eGFR \<45) Overactive thyroid gland
2. Unable to receive CEUS contrast Previous reaction to Sonovue (Ultrasound Contrast) Allergy to sulphur hexafluoride (used in electrical industry in circuit breakers, switch gears \& electrical equipment) Recent acute coronary syndrome or unstable angina, typical angina at rest or frequent or repeated angina/chest pain - all within previous 7 days Recent coronary intervention
3. Previous embolization of artery in region of EVAR (affects imaging quality)
4. BMI \>30 (affects imaging quality)
Maternal and Perinatal Pregnancy Outcome in Women With Heterozygous Hemoglobinopathies

This retrospective study aims to investigate pregnancy outcome in women with heterozygous hemoglobinopathies (regarding gestational diabetes, cholestasis and urinary tract infections) and to analyze if there are aggravated maternal and/or perinatal risks.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women with or without heterozygous hemoglobinopathy

Exclusion Criteria:

* refusal of study participation