cyrilzakka/clinical-trials huggingface dataset:
Epidural Labor Analgesia and Infant Neurobehavior

Infant neurobehavior alteration is predictor of later intelligence development. Many factors would influence or are associated with infant neurobehavior, of which exist or appear during perinatal period. Neuraxial, especially epidural, analgesia to date is the most effective method in relieving labor pain. Although previous studies showed that opioid used in epidural analgesia for labor pain can affect newborn neurobehavior negatively in a dose-escalation associated manner, whether epidural analgesia itself would produce unpredictable effect on newborn neurobehavior is still unknown. Hereby the investigators designed this trial to investigate the hypothesis that epidural analgesia for labor pain control itself would not produce negative effect on infant neurobehavior.


Eligibility Criteria:
Inclusion Criteria:

* \>18years and \<45years
* Spontaneous labor
* Analgesia request

Exclusion Criteria:

* Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
* Participants younger than 18 years or older than 45 years
* Those who were not willing to or could not finish the whole study at any time
* Using or used in the past 14 days of the monoamine oxidase inhibitors
* Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics
* Subjects with a nonvertex presentation or scheduled induction of labor
RCT of SMS for Drivers With Pre-DM

The purpose of this study is to prevent the professional drivers from pre-diabetes to diabetes.

Mobile phone use is almost a routine part of society worldwide. All mobile phones can deliver and receive short-messaging service text messages, providing a perfect medium for delivering information and support. Since short-messaging service is little exploited in clinical research or practice in Chinese population, this study examined the effectiveness of one-way messaging which is less expensive and is easier to undertake. We aimed to determine the effectiveness of using SMS to provide pre-diabetes and diabetes information by promoting healthy lifestyle modification and reducing the two-hour post-glucose loading plasma glucose, the risk of acquiring Type 2 Diabetes Mellitus among professional drivers with pre-diabetes.

Eligibility Criteria:
Inclusion Criteria:

* identified within the last 3 months with pre-diabetes which is defined as a fasting plasma glucose level of 5.6-6.9 mmol/L or a two-hour level after a 75 grams glucose load of 7.8-11 mmol/L based on the World Health Organization 1998 criteria;
* accessible by mobile phone that could receive Chinese text messages.

Exclusion Criteria:

* a history of diabetes mellitus;
* currently on medicines known to alter glucose tolerance;
* did not have a mobile phone;
* unable to read Chinese characters;
* refused to take part in current study.
Mirror Therapy and Hand Rehabilitation

Objective: The purpose of this study is to determine effects of mirror therapy in restoring hand function in patients with flexor lag following orthopedic injuries.

Methods: In a prospective randomized controlled trial, 22 patients with Flexor Lag will be measured. Intervention group will receive mirror therapy, 30-minute a day, 5 days a week for 3-week, as well, half an hour conventional rehabilitation after each mirror therapy session. Patients in the control group will receive the same treatment program, but instead of mirror, they will directly observe the affected hand. Outcome measures including Total Active Motion (TAM), and Disabilities of Arm, Shoulder and Hand (DASH) questionnaire will be administered before and after the treatment period and 3 weeks after the final treatment session.


Eligibility Criteria:
Inclusion Criteria:

* hand orthopedic Injuries
* more active range of motion than passive range of motion

Exclusion Criteria:

* crush injuries
* hand deformities
* not treated fractures and tendon ruptures
* complex regional pain syndrome
* psychiatric problems
DAW2020 on OSA Endotypic Traits

Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. Some OSA patients with low arousal threshold wake up prematurely during an obstructive event and do not have time for spontaneous upper airway (UA) dilator muscle recruitment. As a consequence they are exposed to apnea and hypopnea cycling. In this protocol the investigators will test the effect of DAW2020 administered before sleep on OSA phenotype traits and OSA severity during sleep.

Two overnight sleep studies will be performed: a drug night and a placebo night. The patient will breath spontaneously (without CPAP) for both nights. On the study nights, subjects will present to the laboratory in the evening and be instrumented with a full polysomnigraphy for monitoring sleep, physiological variables (endotypes), and respiratory events. A history and physical examination will be performed on each night prior to beginning the study, as will a urine pregnancy test in premenopausal women. DAW2020 34 mg will be given 4 hours before lights out. Subjects will sleep at least 50% of the night in the supine position. At least four hours of sleep with high quality signal acquisition will be required for a study to be judged adequate. After the first overnight study is completed, there will be a one-week washout period prior to crossing over to the other treatment.

Eligibility Criteria:
Inclusion Criteria:

* Moderate-to-severe OSA (AHI ≥ 15 events/hr)

Exclusion Criteria:

* All participants will be healthy and without major organ system disease that would preclude undergoing the physiological measurements.
* Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
* Use of SNRIs/SSRIs.
* Conditions likely to affect OSA physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.
* Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea:
* Other sleep disorders: periodic limb movements (periodic limb movement arousal index \> 10/hr), narcolepsy, or parasomnias.
* Hypersensitivity to the study drug (angioedema or urticaria)
* Contraindications to DAW2020
* Use of medications that lengthen QTc interval
* Hypokaliemia, hypomagnesemia, uncontrolled thyroid disease
* Severe claustrophobia.
Short-Term Intensive Insulin Therapy Induction of Long-term Glycemic Control

We designed this prospective, randomized control study to compare the benefits between the insulin therapy and OADs after correction of the glucose toxicity with a short period of intensive insulin therapy.

OBJECTIVE-Type 2 diabetes is associated with defects in insulin secretion and insulin action. Hyperglycemia may aggravate these defects, a feature known as glucose toxicity. Previous studies have shown that acute correction of hyperglycemia in subjects with long-standing type 2 diabetes gives only short-term improvement in glycemic control after discontinuation of insulin. The current study attempts to identify any characteristics of patients with newly diagnosed type 2 diabetes (fasting glucose \>300mg/dL) who would have a long-term benefit, in terms of glycemic control, from a brief course of insulin therapy.

RESEARCH DESIGN AND METHODS-Newly diagnosed type 2 diabetic patients with severe hyperglycemia (fasting blood glucose \>300 mg/dL or random blood glucose \>400 mg/dL) will be hospitalized and treated with intensive insulin injection for 10 to 14 days. Oral glucose tolerance will be performed after one week of intensive insulin treatment. After discharge, patients will be randomized to receive insulin injection or oral anti-diabetic drug for further management. Patients will be followed in our clinics and adjust their medication according to their blood glucose levels. Oral glucose tolerance test will be repeated 6 months later, whereas the insulin sensitivity and beta-cell function will be evaluated again.

EXPECTED RESULTS-We will respect that short-term intensive insulin therapy can induce lone-term glycemic control in newly diagnosed type 2 diabetes with severe hyperglycemia.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed type 2 diabetic patients.
2. Hospitalization due to hyperglycemia hyperosmolality syndrome.
3. Those who age between 30 and 80 years old and can inject insulin by themselves.

Exclusion Criteria:

1. Pregnant women.
2. Impaired liver function (ALT \> 120 U/L)
3. Impaired renal function (Serum creatinine \>3.0 mg/dL)
4. Recently suffered from MI or CVA.
5. Patients are acute intercurrent illness.
6. 2-hour C-peptide level \< 1.8 ng/mL.
Human Oral Detection of Glucose Olygomers

Although salivary contents play a major role in the early stage of food digestion process, their role in taste perception of glucose polymers is essentially unknown. It is hypothesized that the differences in salivary contents, more specifically salivary amylase concentration and activity, influence taste perception of glucose polymers and ultimately eating behavior, which is related to risks in various diseases. The current project will investigate the variation in salivary contents across individuals and its role in taste perception of glucose polymers.


Eligibility Criteria:
Inclusion Criteria:

* self-reported healthy adults between the ages of 18-60 who are fluent in English.

Exclusion Criteria:

* adults 61 years old and above
* smokers
* pregnant women
* taking any prescription pain/ insulin medication
* has a history of taste or smell loss or other oral disorders (e.g., burning mouth syndrome)
* has current oral lesions, canker sores, or piercings
* has a history of food allergy
Robotic Gait Training VS.Conventional Rehabilitation in SCI

Until now, there's still no any strong evidence supported "which is the best way to restoration walking ability" in spinal cord injury. Most of the evidence suggest that, there is somehow better after gait rehabilitation for ASIA classification C and D but not improved walking ability for ASIA classification A and B. There is an RCT showed the evidence of repetitive locomotor training and physiotherapy could be improved walking and basic activities of daily living after stroke, these might be also really effect in SCI patients.

This study aim to study the effectiveness of conventional rehabilitation compare with robotic gait training machine in subacute SCI patients.

Eligibility Criteria:
Inclusion Criteria:

* Subacute spinal cord injury ( C5-T12 level) patients.
* ASIA classification C and D.
* No previous joint contracture.
* No severely active medical condition.
* Can easily communicate with no obvious cognitive impairment.
* Given signed inform consent.

Exclusion Criteria:

* Previous injury or other neurological condition that related to neurodeficit in key muscles.
Feasibility Study: Ulthera Treatment of the Buttocks and Thighs

Up to 30 subjects will be enrolled. Enrolled subjects will receive an Ulthera® treatment to one side of the body, treating the lateral buttock region. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve buttock and thigh skin laxity. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 30 to 65 years.
* Subject in good health.
* Skin laxity in the buttocks and thighs.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated and/or weight loss through the follow-up period.
* Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
* Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history: a) Postmenopausal for at least 12 months prior to study; b) Without a uterus and/or both ovaries; or c) A bilateral tubal ligation at least six months prior to study enrollment.

Exclusion Criteria:

* Presence of an active systemic or local skin disease that may affect wound healing.
* BMI equal to or greater than 40.
* Excessive subcutaneous fat in the buttocks and thighs.
* Excessive skin laxity in the buttocks and thighs.
* Significant weight fluctuation (±10 lbs) in the past 6 months.
* Taking weight-loss medications/supplements.
* Surgical or non-surgical treatments to the target areas in the last 12 months, e.g., liposuction.
* Inability to understand the protocol or to give informed consent.
Rituximab Desensitization Therapy for Patients on the Waiting List for Kidney Transplant

This is a study of patients who have a high risk of kidney rejection before kidney transplant. The hypothesis is that treatment with a medication called rituximab will make it possible for them to receive a kidney transplant from a donor who previously did not present a good match.


Eligibility Criteria:
Inclusion Criteria:

* Active status on a kidney transplant waiting list with positive cross match against a living donor

Exclusion Criteria:

* Receipt of a live vaccine within 4 weeks prior to randomization
* Previous Treatment with Rituximab
The Comparison of Strategies to PREPARE Severely CALCified Coronary Lesions Trial (PREPARE-CALC)

The primary objective of this study is to evaluate the success of lesion preparation with either rotational atherectomy or cutting/scoring balloons as well as the long term effects of a hybrid sirolimus-eluting stent in an angiographically well-defined group of patients with complex calcified coronary lesions.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical inclusion criteria

   * Age above 18 years and consentable
   * Angiographically proven coronary artery disease
   * Anginal symptoms and/or reproducible ischemia in the target area by ECG, functional stress testing or fractional flow reserve
   * Written informed consent
2. Angiographic inclusion criteria

   * De-novo lesion in a native coronary artery
   * Target reference vessel diameter between 2.25 and 4.0 mm by visual estimation
   * Luminal diameter reduction of 50-100% by visual estimation
   * Severe calcification of the target lesion

Exclusion Criteria:

1. Clinical exclusion criteria

   * Myocardial infarction (within 1 week)
   * Decompensated heart failure
   * Limited long term prognosis due to other conditions
2. Angiographic exclusion criteria

   * Target lesion is in a coronary artery bypass graft
   * Target lesion is an in-stent restenosis
   * Target vessel thrombus
Effectiveness of Deep Transcranial Magnetic Stimulation in Depression

We intend to investigate whether deep transcranial magnetic stimulation (DTMS), a novel brain stimulation technique, is effective for treating major depression. We hypothesize that 4 weeks of DTMS will be associated with significant improvements in depressive and anxious symptoms without significant side effects.

The aim of this pilot study is to assess, naturalistically, the effectiveness of deep transcranial magnetic stimulation (DTMS) in a sample of subjects with treatment-resistant depression. To do this, enrolled depressed outpatients will be assigned to receive 4 weeks of daily DTMS and will be evaluated at baseline and during week 5. We hypothesize that treatment with DTMS will be associated with significant clinical improvements in depressive and anxious symptoms, and will be well tolerated.

Eligibility Criteria:
Inclusion Criteria:

* Presence of a current major depressive disorder (according to the DSM-IV-TR) that has not improved after ≥ 1 but ≤ 5 adequate antidepressant trial(s) in the current episode
* Baseline score ≥ 15 on the QIDS-C
* Stable medication regimen (\> 4 weeks)

Exclusion Criteria:

* Psychotic features in the current episode
* Lifetime history of psychotic disorders and/or bipolar I or II disorders
* Substance or alcohol abuse/dependence in the past 6 months
* Lifetime history of a major neurological disease (e.g., Parkinson's, stroke)
* Uncontrolled medical disease (e.g., cardiovascular, renal)
* Pregnancy and/or lactation
* Presence of a specific contraindication for DTMS (e.g., personal history of epilepsy, metallic head implant)
* Hearing loss
* Personal history of abnormal brain MRI findings
Photoaging Reversing After Picosecond Laser With DLA Assessed by Cellular Resolution OCT in Asian Patient With Melasma

Background Melasma is a commonly acquired hypermelanosis that affects facial sun exposed areas, most commonly in Asians and other darker skin type females. Recent evidence has demonstrated melasma to be a photoaging disorder. The histological findings of melasma are similar to photoaging and include solar elastosis, increased mast cells and sebaceous glands, as well as increased vascularization. Pendulous active melanocytes with weakened basal membranes, and changes in nuclear morphology and chromatin texture of adjacent basal keratinocytes also seemed to be a characteristic feature of melasma.

Objectives:

To compare the difference of photoaging features of melasma skin and normal skin by optical coherence tomography (ApolloVue® S100 Image System, a 510(K) class II medical device) and reversal of photoaing features by 755nm picosecond alexandrite laser with diffractive lens.

Methodology:

We enroll 20 adults with facial melasma. The patients received 755nm picosecond alexandrite laser with diffractive lens array over whole face at W0, W4, and W8. Evaluation with VISIA, optical coherence tomography, Cutometer MPA580 at W4, W8, W12. All the patients will be instructed with use of moisturizer, gentle cleaning, and sunscreen use.

Anticipated results and applications:

This study expects to

1. understand the role of 755nm picosecond alexandrite laser with diffractive lens of reversal of photodamage and improving the melasma by evaluation with optical coherence tomography and other noninvasive methods.
2. Set evidence based guidance for melasma treatment and set the protocol or clinical path.


Eligibility Criteria:
Inclusion Criteria:

* Willing to sign a written inform consent form
* Adults over the age of 20.
* Patients with melasma on their faces.

Exclusion Criteria:

* have received any cosmetic treatments, e.g. laser, pulsed light, and chemical peels within six months before participating the trial.
* Have taken oral contraceptives or received hormone therapy within one year before participating the trial.
* Has other pigmented diseases or inflammatory diseases on face.
* Are pregnant or breastfeeding.
* Has conditions with poor wound healing, keloids or photosensitivity.
Chlorine Dioxide Versus Saline for Wound Irrigation

This research is being done because the investigators are trying to examine the safety and effectiveness of this wound cleaning liquid, CACD (chlorine dioxide). The investigators are trying to see if this liquid has the ability to decrease infection rates and decrease the scarring effects from the healing process. In animal studies, CACD has been shown to decrease scar formation and decrease the risk of wound infections. CACD is also used for the treatment of burns to decrease infection rates and improve wound healing. CACD is not FDA approved for this specific use, but it is FDA and USDA approved for reducing bacterial contamination on meat and food products for human consumption. In addition, an investigational drug (IND) application has been submitted to the FDA for this study. The FDA has approved the use of this solution for this study.


Eligibility Criteria:
Inclusion Criteria:

* 18-100 years old
* simple laceration requiring irrigation \& sutures
* patient has method of contact
* patient is willing to return to ED in 3-4 mths

Exclusion Criteria:

* immunocompromised
* consult required for repair
* diabetic
* require antibiotics
Safety and Pharmacokinetic Characteristics of DKF-313

This is a randomized, open-label, single-dose, 2-treatment, 2-way, 2-period crossover study to evaluate the safety and the pharmacokinetic characteristics of DKF-313 (dutasteride and tadalafil) in healthy male volunteers.

This study is conducted to evaluate the pharmacokinetics of DKF-313 (dutasteride and tadalafil) comparing with the concomitant administration of AVODART and CIALIS in healthy male volunteers.

Eligibility Criteria:
Inclusion Criteria:

1. Age 19 to 29 years
2. BMI 17.5 to 30.5 kg/m2 and body weight 55 kg or more
3. No congenital or chronic diseases within 3 years, no disease symptoms or findings
4. Eligible according to the laboratory results of hematology, blood chemistry and urinalysis and ECG
5. Voluntarily signed the informed consent form 6. Willing to participate in the study

Exclusion Criteria:

1. Clinically significant disorders of blood, kidney, endocrine, respiratory system, gastrointestinal system, urology, cardiovascular system, liver, psychiatry, neurology or allergy
2. Gastrointestinal diseases or surgery which may affect absorption of the investigational products
3. ALT or AST \> 2xULN
4. Excessive alcohol consumption (\> 210 g/week) within 6 months
5. Participated and administered the investigational products in other clinical trial within 2 months
6. SBP ≤ 100 mmHg or ≥ 150 mmHg or DBP ≤ 60 mmHg or ≥ 100 mmHg
7. History or positive result of serious alcohol or drug abuse within 1 year
8. Drugs which induce or inhibit drug metabolism within 1 month
9. Smoked more than 10 cigarettes a day
10. Prescribed drugs or over-the counter drugs within 10 days
11. Donated whole blood within 2 months or apheresis within 1 month
12. Severe acute/chronic medical and mental conditions or lab abnormalities which may increase the risk or interfere in the interpretation of study results
13. Hypersensitivity to tadalafil or phosphodiesterase type 5 inhibitor, and dutasteride or 5-α reductase inhibitor, or other drugs including aspirin, antibiotics, etc.
14. Galactose intolerance, fructose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
15. CYP3A4 inhibitors or CYP3A4 inducers within 2 weeks
16. Myocardial infarction within 90 days
17. Unstable angina or angina during sexual intercourse
18. Heart failure (New York Heart Association Class 2 or higher) within 6 months
19. Uncontrolled arrhythmias
20. Stroke within 6 months
21. Inherited retinal degeneration including retinitis pigmentosa
22. Vision loss in one eye due to non-arteritic anterior ischemic optic neuropathy (NAION)
23. Plans to donate blood for at least 6 months after final dose of the investigational products
24. Unwilling to comply with the lifestyle guidelines in the protocol
25. Not eligible due to other reasons at the investigator's discretion