cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Motilitone on Gastric Emptying in Patients With Functional Dyspepsia: Evaluation Using MRI Method

Functional dyspepsia (FD) is a disorder characterized by chronic or recurrent upper abdominal pain or discomfort in the absence of a specific structural cause.1 Several mechanisms have been suggested to underlie dyspeptic symptoms. In a barostat study by Tack et al.2, impaired gastric accommodation to a meal was found in 40% of patients with FD, and this abnormality was associated with early satiety. Delayed gastric emptying (GE) was also found in almost 40% of patients with FD, and was associated with the symptoms of postprandial fullness, vomiting and early satiety.3-5 Improving gastric accommodation and prokinetic effect seem to be an attractive physiological target in patients with FD. Motilitone (Dong-A ST, Yongin, Korea) is a new herbal drug that was launched in December 2011 in Korea for treating patients with FD. It has multiple mechanisms of action such as fundus relaxation, visceral analgesia and prokinetic effects.6 The current study aims to evaluate effects of motilitone on gastric emptying and accommodation after a meal in patients with FD using three-dimensional gastric volume measurements by magnetic resonance imaging (MRI). Patients are randomly allocated to receive either motilitone 90 mg daily, motilitone 180 mg daily or placebo in a double blinded manner. After 2 weeks of treatment, patients undergo gastric MRI. The primary endpoint is gastric emptying rate. The secondary endpoints are gastric accommodation and symptom improvement.

Same as above

Eligibility Criteria:
Inclusion Criteria:

1. 20 and 70 years of age
2. Diagnosed of functional dyspepsia patients by ROME III diagnostic criteria
3. Symptom scores three-point by 8 kinds of symptoms on NDI-K table
4. Signed written informed consent.

Exclusion Criteria:

1. Any functional GI diease
2. Previous abdominal surgery
3. pregnancy or lactation
4. Other conditions likely to interfere with study procedures. as judged by the investigator
5. Allergic history to motilitone
6. Contraindications to MRI
7. Significant cardiopulmonary disease
8. Significant renal(serum creatinine level≥1.5 x the upper normal limit) or liver (AST or ALT≥2.5xULN)disease
9. Can not be stopped taking medications that gastric motility booster and antacid prior to the start of the study
10. Uncontrollable diabetes mellitus (HbA1C\>7%)
11. Any malignancies within 5 years prior to the start of the study
Use of Consumer Sleep Technology to Treat Shift Work Disorder

The purpose of this study is to examine the effectiveness of a personalized light exposure schedule for Shift Work Disorder (SWD) in night shift workers compared to a non-personalized light exposure schedule.

Participants will be randomized into each condition (n = 25) in a 1:1 ratio. Variables of interest, dim light melatonin onset (DLMO) and shift work disorder (SWD) symptoms, will be assessed before and after the intervention, which will last two weeks. All participants (N=50) will be asked to wear an Apple Watch for two weeks leading up to an in-lab visit. Activity data collection from the Apple Watch will be processed through a mathematical model of the human circadian pacemaker (previously validated in SWD) to generate estimates of DLMO. This two-week period is followed by a 27-hour laboratory visit for pre-treatment assessment of DLMO (hourly saliva melatonin samples over 24 hours). At the end of this visit, participants will receive an orientation to the SHIFT mobile application, where they will be able to assess their prescribed light exposure schedule.

Eligibility Criteria:
Inclusion Criteria:

* Participants must work at least 2 night shifts a week
* Participants must have night shifts starting between 18:00 and 02:00 and lasting 8 to 12 hours
* Participants must have maintained this night shift schedule for at least 6 months
* Participants must have Shift Work Disorder, diagnosed based on ICSD-3 criteria

Exclusion Criteria:

* Medical history of central nervous system disorders
* Medical history of other sleep disorders
* Diagnosis of an unstable major medical condition medical chart review
* Dependence on alcohol (≥ 4 beverages a day)
* Heavy tobacco use (≥ 10 cigarettes per day)
* Recreational drug use
* Use of medications impacting central nervous system functioning
* Caffeine use in excess of 5-6 servings (\~ 600mg) per day
* Pregnancy
Radiation Therapy Plus Durvalumab for Tumor-Stage Cutaneous T-Cell Lymphoma

This is a single arm, single stage pilot study of radiation therapy plus durvalumab for tumor-stage cutaneous T-cell lymphoma (CTCL).


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily provide written IRB-approved consent
* Age ≥ 18 years
* Histologically proven CTCL
* Stage IIB-IV CTCL with ≥2 cutaneous tumors assessable for response
* At least one cutaneous tumor amenable to radiation therapy. Must have at least 1 tumor assessable for response that will not undergo radiation.
* Adequate organ function
* Prior treatment is allowed if at least 4 weeks have elapsed since last chemotherapy and/or radiation and the subject has recovered from all treatment related toxicity

Exclusion Criteria:

* Prior allogeneic stem cell transplant.
* Prior treatment with a PD-1/PD-L1 inhibitor
* Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment.
* Current or prior use of immunosuppressive medication within 14 days prior to first dose of durvalumab.
* Known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection.
* History of hypersensitivity to durvalumab or any excipient
* Receipt of live attenuated vaccination within 30 days prior the first dose of durvalumab.
* Female subjects who are pregnant, breast-feeding or female patients of reproductive potential who are not employing an effective method of birth control
* Male subjects who are not employing an effective method of birth control
* Uncontrolled current medical illness, including, but not limited to ongoing or active infections, symptomatic congestive heart failure, unstable angina pectoris,unstable cardiac arrhythmia and/or psychiatric illness or other condition that in the opinion of the investigator would limit compliance with study requirements.
Evaluation of the Relationship Between Healthy Eating and Intrinsic Capacity in Elderly Individuals

The aim of this study is to evaluate the relationship between intrinsic capacity and healthy eating in elderly individuals.

The relationship between the healthy eating index and intrinsic capacity in elderly individuals is unknown.

The aim of this study is to evaluate the relationship between intrinsic capacity and healthy eating in elderly individuals.

Eligibility Criteria:
Inclusion Criteria:

* 65 years and older
* Those who agreed to participate in the study
* Orally fed

Exclusion Criteria:

* Not voluntarily participating in the research
* Having a serious life-threatening condition (critical illness, hospitalization in the intensive care unit, acute complication)
* Those who do not have a mental disability that cannot answer the questions (Mental retardation, Alzheimer's, etc.)
* Major psychiatric illness
* congenital or acquired muscle disease
Effect of Ginkgo Biloba Extract on Cognitive Function in Acute Ischemic Stroke

The purpose of this study is to determine the effect of ginkgo biloba extract on cognitive function in acute ischemic stroke.

Vascular brain injury is a common post-stroke complication that can reduce cognitive function and lead to vascular cognitive impairment, placing a significant burden on families and society. The purpose of this study is to determine the effect of ginkgo biloba extract on cognitive function in acute ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a definitive clinical diagnosis of acute ischemic stroke;
2. Age≥18 years, regardless of sex；
3. Primary education level or higher; baseline MoCA score of 10-25 points;
4. Able to complete cognitive scale scoring;
5. Informed consent is signed and ginkgo biloba extract therapy is initiated within 14 days of onset.

Exclusion Criteria:

1. Transient ischemic attack；
2. Patients who received emergency reperfusion therapy (including intravenous thrombolysis and endovascular thrombectomy) at onset;
3. Combined with other neurological diseases, such as neurodegenerative diseases (e.g., Alzheimer's disease, Parkinson's disease, Lewy body dementia, and frontotemporal dementia), optic neuritis, epilepsy, central nervous system infections (e.g., AIDS and syphilis), traumatic brain injury dementia, etc；
4. Currently using psychoactive medications (e.g., antidepressants) or anti-epileptic drugs, or if the time since their last use of these medications was less than 5 half-lives (per the pharmacokinetics of each specific medication; for drugs with unknown half-lives, a 1 month washout period was required)；
5. Had a pre-existing diagnosis of a cognitive disorder；
6. Currently taking medications intended to improve cognitive function or prevent dementia (e.g., cholinesterase inhibitors, memantine, nootropics), or if the washout period since their last use of these medications was less than 5 half-lives as specified in each drug's pharmacokinetics. For drugs with unknown half-lives, a minimum 1 month washout period was required；
7. Severe liver and kidney dysfunction;
8. Active ulcer or bleeding diathesis；
9. Allergy to preparations containing ginkgo biloba extract；
10. Pregnant or lactating women, patients with a life expectancy less than 6 months, and those unable to complete the study for other reason；
11. Unwillingness to be followed up or poor treatment compliance;
12. Those who are participating in other clinical investigators, or who have participated in other clinical studies within 3 months prior to enrollment;
13. Other conditions that the investigators deemed unsuitable for enrollment.
Mindfulness in Endometrial and Cervical Cancer

Patients with endometrial cancer who will be undergoing surgery or patients with cervical cancer who will be treated with chemoradiation will be randomized to utilize the Headspace smartphone application or not prior to their anticipated treatment.

A diagnosis of cancer can be a major stress-inducing event. The prevalence of depression in patients diagnosed with cancer is estimated up to 16%. Practicing mindfulness is a cost-effective treatment which can also help manage treatment adverse effects and cancer-related symptoms.

Even short exposure and practice of mindfulness exercises have demonstrated improved subjective and objective measurements of stress and anxiety with breast biopsies. Patients with breast cancer also have improved quality of life with mindfulness training. Self-guided mindfulness with smartphone applications, specifically the app Headspace, has been associated with positive benefits and ease of use in the general population and among cancer patients.

A patient's inherent level of baseline mindfulness has been associated with lower pain scores following minimally invasive hysterectomy. This study did not specifically encourage practice of mindfulness exercises. Our own study of post-operative opiate usage in women following minimally invasive hysterectomy contains self-reported data of women using opiates to relax or help sleep. This suggests that mindfulness exercises may improve quality of life in these areas and thus reduce opiate usage. Patients undergoing minimally invasive hysterectomy for treatment of endometrial cancer were specifically chosen as a study cohort to build on our own data and that currently reported in the literature as well as the highest incidence of this cancer as a gynecologic malignancy. The second study cohort chosen was women with cervical cancer undergoing definitive treatment with chemo-sensitizing radiation given the significant endeavor required for complete treatment. Additionally, these women are often younger with the diagnosis of cervical cancer often being their first major medical diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of either 1) endometrial cancer undergoing surgery or 2) cervical cancer undergoing chemo-sensitizing radiation
* Access to a smartphone

Exclusion Criteria:

* Non-English speaking
* No access to smartphone
* Current use of Headspace application
2% Chlorhexidine (CHX) vs CaOH2 (CH) Calcium Hydroxide Paste as an Intracanal Medicament

This is a Pilot Phase III single-blind randomized controlled clinical trial in patients, aged 18 years and older, presenting with symptoms of apical periodontitis. The overall goal is to assess whether 2% Chlorhexidine (CHX) is superior to Calcium Hydroxide in reducing interappointment pain.

This is a Pilot Phase III single-blind randomized controlled clinical trial in patients, aged 18 years and older, presenting with symptoms of apical periodontitis. Patients will be treated with one of two current clinically-used medications, 2% chlorohexidine (intervention) vs. calcium hydroxide (standard-of-care). One week following treatment (+/- 2 days), patients will return for reevaltuion of apical periodontitis symptoms, via patient's pain perception after a bite test.

The primary objective of the proposed study is to determine if there is a difference in 7-day (+/- 2) post-procedure apical periodontitis following randomization to either 2% chlorohexidine vs. calcium hydroxide paste among patients presenting with symptoms of apical periodontitis. Additionally, the investigators will assess the number of adverse events that occur in each treatment group to determine if there appears to be a difference across groups, descriptively.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* symptomatic apical periodontitis (positive to the bite test)
* restorable tooth
* requires root canal therapy
* able to undergo informed consent process
* must be English or Spanish speaker

Exclusion Criteria:

* Cracked tooth
* non-restorable tooth
* no pain medication or antibiotic taken in the past 3 days
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel

To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 22
2. Diagnosis of symptomatic benign bowel stricture with at least 2 previous dilations.
3. Willing and able to complete protocol required follow up
4. Willing and able to provide written informed consent
5. Stricture length ≤ 5 cm

Exclusion Criteria:

1. Female subjects who are pregnant or breastfeeding or plan to get pregnant in next 12 months
2. Contraindication to endoscopy, anesthesia, or deep sedation.
3. Suspicion of malignant bowel stricture NOTE: Biopsy should be taken for every stricture during the initial endoscopy, however endoscopic balloon dilation may proceed without awaiting results if suspicion for malignancy is low in the opinion of the investigator.
4. Benign stricture due to extrinsic compression
5. Stricture is not amenable to standard balloon dilation (e.g. severe angulation, unable to pass guidewire, etc.)
6. Stricture complicated with abscess, fistula, perforation, leakage or varices
7. Stricture segment has moderate to severe active inflammation at the time of treatment. Moderate to severe inflammation is defined as any one of; ulcers \>0.5cm in diameter, ulcerated surface \>10%, affected (inflamed) surface \>50%, marked erythema, absent vascular pattern, significant friability, or erosions
8. Multiple clinically significant strictures unable to be treated with a single balloon (i.e. total segment length must be ≤5cm) NOTE: Clinically significant strictures include those that are unable to be passed by the endoscope.
9. Received steroid injections into target stricture in the last 8 weeks
10. Stricture is not able to be dilated to ≥15mm in small bowel or ≥18mm in large bowel
11. Diagnosis of metastatic cancer of any type that is not considered in remission or non-metastatic cancer that may require radiation treatment in the pelvic region (e.g. prostate cancer)
12. Suspected perforation of gastrointestinal tract
13. Active systemic infection
14. Allergy to paclitaxel
15. Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per relevant societal guidelines
16. Chronic systemic steroid use (defined as greater than 10 mg/day) for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use
17. Condition requiring treatment in urgent setting
18. Life expectancy of less than 24 months
19. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety, such as recent myocardial infarction, severe pulmonary disease, bleeding diathesis, large thoracic aneurysm, pharyngeal or cervical deformity, etc.
20. Current participation in another pre-market drug or medical device clinical study unless in long term follow-up
Effect of Mulligan Snag and Diaphragmatic Release on Thoracic Kyphosis

the aim of this study is to investigate the efficacy of mulligan snag mobilisation and diaphragmatic release on upper crossed syndrome

Acquired postural disorders can be a consequence, to a large extent, of contemporary living and working conditions. Some of the most typical factors include continuous use of mobile phones and computers, working in sedentary jobs. Prolonged incorrect posture and reduced physical activity present a dis-balance in the musculature . It can also lead to vision issues, as well as headaches, musculoskeletal issues, and pain, as well as a multitude of other symptoms.

Upon the available research studies, there is not study conducted to investigate the effect of mulligan SNAG mobilization and diaphragmatic release in upper crossed syndrome patients this trial has four groups; one will receive diaphragmatic release + conventional, the second will receive mulligan SNAG mobilization, and conventional, the third will receive mulligan SNAG mobilization+diaphragmatic release+conventional, the fourth subjects will receive conventional

Eligibility Criteria:
Inclusion Criteria:

* Age ranged from 17 to 22 years .
* Body Mass Index from 20 to 25 kg/m² .
* All participants have an intensity of neck pain on VAS (4-8) (moderate cases) .
* The subjects were chosen from both sexes.
* All participants have kyphosis angle ≥42°
* All participants have mechanical neck pain and FHP (craniovertebral angle CVA \< 49) CVA of \< 49) .

Exclusion Criteria:

* Malignancy
* Fractures of the cervical spine
* Cervical radiculopathy or myelopathy
* Vascular syndromes such as vertebrobasilar insufficiency
* Rheumatoid arthritis
* Neck or upper back surgery
* Taking anticoagulants
* Local infection
* Whiplash injury
Acupuncture for Pain Relief During Induced Labour in Nulliparae

The study was primarily designed to assess the role of acupuncture in reducing the need for epidural analgesia for pain relief during induced labour. The other outcomes of labour were to be observed in addition.

The study was limited to women in their first pregnancy having labour induced for prolonged pregnancy or mild hypertension. The study involved randomised groups managed with manual acupuncture, electro acupuncture, sham acupuncture and a no-treatment control group.

Eligibility Criteria:
Inclusion Criteria:

* nulliparae
* having labour induced for prolonged pregnancy or mild hypertension
* no previous experience of acupuncture
* give written informed consent

Exclusion Criteria:

* all who do not meet the inclusion criteria
Estrogen Receptors and Peripheral Artery Disease

It is estimated that \>200 million people have Peripheral artery disease (PAD) worldwide. PAD is related to increased morbidity or mortality in affected patients. More severe forms of PAD are surgically managed. Estrogen receptors (ERs) are strictly linked with vascular disease, and may be involved also in PAD onset and progression. This study will explore the expression of ERs, (ER-alpha, ER-beta,and a G protein-coupled of estrogen receptor -GPER-) in vessel wall of arteries of operated PAD patients, through the entire clinical spectrum of PAD.

PAD is the atherosclerotic obstruction of the arteries of the lower extremities and it is widespread especially in highly developed countries. The most common complication of PAD is critical limb ischemia with rest pain and leg ulcers. To date the pathophysiology of PAD is linked to atherosclerosis but other pathways are also under evaluation. A recent study (Serra et al) investigated the presence of ER-alfa, ER-beta, and GPER in the wall of normal and varicose veins.

The aim of this observational study is to evaluate the expression and the role of estrogen receptors in patients with PAD, and undergoing surgical treatment with reconstructive arterial surgery. Therefore, we will collect tissue samples from diseased arteries that will be further analyzed for ER expression. We will then correlate the results with the clinical spectrum of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with peripheral artery disease (PAD) eligible to receive arterial reconstructive open surgery.

Exclusion Criteria:

* malignancy
* estrogen therapy
Induction of Labor in Women With Unfavorable Cervix: Dilapan Versus Foley Bulb

Women undergoing mechanical cervical ripening for labor induction will be randomized to Dilapan-S® versus Foley bulb. The investigators hypothesized that osmotic cervical dilators (Dilapan-S®) are as effective as Foley bulb catheter in rates of vaginal delivery.

Historically, mechanical methods were the first methods developed to ripen the cervix or to induce labor. Dilapan-S® a synthetic osmotic cervical dilator made of a patented hydrogel (AQUACRYL), works by stimulating the release of endogenous prostaglandins, which degrade collagen fibers and soften the cervix. Additionally, it dilates the cervix gradually and the effect is gentle as well as predictable. Recently, Dilapan-S® has been approved by the FDA as a mechanical dilator for cervical ripening. There are no data comparing this newly approved Dilapan-S® to the Foley catheter, the most commonly used mechanical dilator method. Therefore, The investigators propose a randomized controlled trial to determine the efficacy of Dilapan-S® compared with Foley catheter for cervical ripening before induction of labor in pregnant women greater than 37 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman scheduled for induction of labor.
* Age between 18 and 45 years.
* Understanding and capable to sign informed consent.
* Singleton pregnancy.
* Gestational age ≥ 37 0/7 weeks.
* Live fetus in cephalic presentation.
* Intact membranes.
* Pelvic exam (sterile vaginal exam) of less than or equal to 3cm and at most 60% effaced.

Exclusion Criteria:

* Iodine allergy.
* Active labor or oxytocin has been administered.
* Chorioamnionitis.
* Prior uterine or cervical surgery.
* Non reassuring fetal status requiring immediate delivery.
* Non-cephalic fetal presentation.
* Active vaginal bleeding from cervical os.
* Placenta previa.
* EFW \> 5000 gm(non diabetic) or \> 4500gm (diabetic).
* Other contraindication to vaginal delivery.