cyrilzakka/clinical-trials huggingface dataset:
Combined Electroacupuncture and Auricular Acupuncture for Persistent Insomnia

This is a randomized controlled trial to evaluate the clinical efficacy of combined electro-acupuncture and auricular acupuncture for persistent Iinsomnia in the adult population in Hong Kong.

Combined electro-acupuncture and auricular acupuncture is potential to be an alternative treatment for primary insomnia. The purpose of this study is to evaluate the clinical effectiveness of combined electroacupuncture and auricular acupuncture on persistent insomnia. This is a randomized double-blinded controlled trial. Patients will be randomly assigned to the electro-acupuncture group, the electro-acupuncture plus auricular acupuncture group or the waitlist controlled group. Patients will be put into groups and then compared.The chance of getting into each group is 3:3:1.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or above
* Hong Kong residents
* Ethnic Chinese
* Meet the diagnosis criteria of presistent insomnia for at least 3 months according to Current Diagnostic and Statistical Manual of Mental Disorders (the proposed Fifth Edition)
* Insomnia more than 3 nights per week for at least 3 months
* Willing to give informed consent
* Able to comply with trial protocol

Exclusion Criteria:

* Have a Hamilton Depression Rating Scale scores above 18
* Have sleep apnea or periodic limbs movement disorder detected by overnight polysomnography
* Have suicidal risk as assessed by the Hamilton Depression Rating Scale suicidal risk item
* Have current major depressive disorder, generalized anxiety disorders or panic disorder, manic or hypomanic episode, substance use disorders except caffeine and nicotine, organic mental disorder, schizophrenia or any other psychotic disorder
* Receiving psychotropic drugs with dosage changes in the last 4 weeks prior to screening, baseline or during the study
* Have valvular heart defects or bleeding disorders or were taking anticoagulant drugs
* Are pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception
* Have any unstable psychiatric conditions or serious physical illnesses which are judged by the investigator to render unsuitable or unsafe
* Have infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe
* Taking Chinese herbal medicine or over-the-counter drugs which are intending for insomnia within the last 2 weeks prior to baseline or during the study
* Any acupuncture or auricular acupuncture treatment during the previous 6 months prior to baseline
Inflammatory Response to Anti Inflammatory Therapy in Children With Sleep Disordered Breathing

This study will assess in a double blind placebo controlled fashion the effects of a 12 week course of oral montelukast/placebo on polysomnographic and radiological findings and will characterize the systemic (serum,urine) and local (upper airway collected biological samples) inflammatory response in children (2-10 years of age) with sleep disordered breathing, fittingthe inclusion and exclusion criteria.


Eligibility Criteria:
Inclusion Criteria:2-10 years old

1\<AHI\<8 measured in an overnight PSG

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Exclusion Criteria:

Asthma Previous use or allergy to montelukast Use of antibiotics in the previous 3 weeks Use of corticosteroids in the previous 3 months Craniofacial dysmorphism Genetic or metabolic defined illnesses Adenotonsillectomy or adenoidectomy in the past

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Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in China

The objective of this study was to assess the effectiveness of adalimumab on health and disability outcomes in participants with rheumatoid arthritis (RA) in China.

This was a prospective, multicenter, observational study to assess the effectiveness of adalimumab on health-related quality of life (QoL) and work productivity in participants with rheumatoid arthritis (RA) in routine clinical practice in China. The decision to prescribe adalimumab for RA was based on clinical practice criteria without taking participation in this study into account. Participants were included in the study after a physician's decision of initiating adalimumab treatment. Participants were followed for 24 weeks, with scheduled study visits at baseline, Week 12 and Week 24.

Eligibility Criteria:
Inclusion Criteria:

* Participant had a diagnosis of rheumatoid arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) classification criteria and/or the ACR/the European League against Rheumatism (EULAR) 2010 classification criteria (any duration since diagnosis)
* Participants with moderate to severe RA defined as a Disease Activity Score in 28 Joints (DAS28) Erythrocyte Sedimentation Rate (ESR) or DAS28 C-Reactive Protein (CRP) score \>3.2
* Biologically treatment naïve and initiated adalimumab at baseline visit, as per standard daily clinical practice
* Availability of clinical data of the previous 12 weeks prior to baseline
* Ability to self-complete participant questionnaires.
* Participants had signed the authorization (or informed consent where applicable) to disclose and use personal health information after having been prescribed adalimumab

Exclusion Criteria:

* Participants who were pregnant or breastfeeding at enrollment or wished to become pregnant in the next 24 weeks.
* Participation in any RA-related clinical trial at the time of enrollment, at baseline, or at any point during the past 24 weeks prior to baseline
* Participants, who in the clinician's view, may not have been able to accurately report their quality of life (QoL) or prior resource utilization
* Participants, who in the clinician's view, may not have been able to adhere to adalimumab therapy over 24 weeks
Graftless Lateral Maxillary Sinus Lift Balloon by Different Antrostomy Sizes With Simultaneous Implant Placement

two groups undergo for graftless sinus lift using AMBE (antral membrane balloon elevation) through different antrostomy size with simultaneous implant placement

control group undergoes for graftless sinus lift using AMBE through large antrostomy with simultaneous implant placement. While, study group undergo for graftless sinus lift using AMBE through small antrostomy with simultaneous implant placement. the aim of the study is assessment the effect of antrostomy size on bone formation in graftless sinus lift with simultaneous implant placement.

CBCT will be done before and after the surgery and after 6 months to assess of amount bone gain in mm.

implant stability after 6 months will be determined by using Osstell. Primary outcome: amount of bone gain which will be measured by using linear measurement from CBCT.

secondary outcome: stability of implant by using osstell

Eligibility Criteria:
Inclusion Criteria:

1. Patients with atrophic maxilla and pneumatization of maxillary sinus with residual bone height from 3-6mm.
2. Both sexes
3. No intraoral soft and hard tissue pathology,
4. No systemic condition that contraindicate implant placement

Exclusion Criteria:

1. Sinus pathology.
2. Heavy smokers more than 20 cigarettes per day.
3. Patients with systemic disease that may affect normal healing.
4. Psychiatric problems.
5. Disorders to implant are related to history of radiation therapy to head and neck neoplasia or bone augmentation to implant site
Patient Acuity Rating: a Tool to Prevent In-Hospital Cardiac Arrest

The purpose of this study is to evaluate the accuracy of medical personnel in their ability to predict the likelihood of non-intensive care (ICU), ward patients to clinically deteriorate (defined as a cardiac arrest, unplanned ICU transfer, or unexpected death)via the use of a clinical judgement-based tool designed for this study, Patient Acuity Rating (PAR), to predict short-term clinical deterioration. We will compare the ability of this tool to predict clinical deterioration compared to accepted physiology-based tools and tools combining judgment and physiology as well as other markers of deterioration such as physician order changes. We will compare the sensitivity, specificity and area under the curve of these combined models to the predictive models including only physiology or clinical judgment. We will assess the correlation between specific physician orders and patient deterioration to determine whether specific clinical activities, such as emergently obtained radiology exams, predict impending deterioration. We hypothesize that PAR will be a useful tool for predicting clinical deterioration across the institution and that it will have a higher average accuracy for predicting clinical deterioration in non-ICU inpatients within 24 hours than the physiology-based tools alone. We further hypothesize that a combined metric which includes both the PAR and the individual physiologic components that comprise physiologic tools will not significantly improve prediction over the PAR alone. We further propose to use PAR to prospectively risk stratify patients for preemptive evaluation by the Rapid Response Team. We hypothesize that intervening on high risk patients by preemptively activating the hospital's Rapid Response Team (to assess and treat patients as needed) will decrease cardiac arrest rates and mortality.


Eligibility Criteria:
Inclusion Criteria:

* Non-ICU ward inpatients
* PAR of 5 or above
* Ages 18+ years

Exclusion Criteria:

* ICU or outpatients
* PAR of 4 or lower
* Ages 17 years and under
Clinical and Therapeutic Evaluation of the Infection by HIV/AIDS

The aim of the Post Marketing Study (PMS) is to evaluate the efficacy and safety profile of nevirapine in the management of the HIV/AIDS in an open environment.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of HIV/AIDS, no age limits
* patients could be naïve to treatment or pretreated with other antiretroviral agents

Exclusion Criteria:

* Patients with known hypersensitivity to nevirapine or any other component of the product
90 DAYS: An Entertainment Education Intervention to Evaluate a Short Film About HIV Status Disclosure

This investigation seeks to understand if and how, the 90 Days film can be used as an intervention to address HIV-related stigmas, intimate partner status disclosure and HIV ART medical adherence among Black HIV positive women.


Eligibility Criteria:
Inclusion Criteria:

* Black women ages 18-50
* clinically diagnosed with HIV/AIDS
* Speak and comprehend English

Exclusion Criteria:

* pregnant women
Consistency in Individual Differences in Energy Intake Following Acute Exercise

The importance of exercise for weight control is well documented; however if exercise results in an increase in food intake, the beneficial effect of exercise may not be seen. This study addresses a gap in the current literature and examines why some people eat more after exercise and why some people eat less and also examines whether these responses are consistent over time. Participants in this study will be asked to come to our center on 7 different occasions over a 3-4 month period. The first visit will be an assessment visit where body weight and body composition will be measured, questionnaires will be completed, and an exercise test will be performed. During the remaining 6 visits (3 pairs of sessions with visits in each pair separated by 48-96 hours) the procedures will be nearly identical. Upon arrival at our center, participants will consume a meal replacement, complete a series of questionnaires and then either rest or walk on a treadmill for 30 minutes (3 days will be resting and 3 will be exercising). One hour following the exercise/resting session, individuals will be given access to a buffet of food, unaware that their food intake will be monitored. All food will be weighed and measured before and after the eating period and the amount of food consumed after each pair of exercise and resting conditions will be compared to one another. It is hypothesized that the difference in food intake will be consistent across pairs of testing sessions. Findings from this study will help us to better understand the relationship between exercise and food intake and may ultimately lead to future studies that can address the clinically significant question of why some individuals gain weight and others lose weight when engaging in exercise training programs. Findings from this study may also help to develop exercise programs that maximize the beneficial effect of exercise on body weight.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-45 years
* BMI between 25.0 and \<35.0 kg/m2
* Female
* Sedentary, defined as exercising at a moderate-intensity for less than 60 minutes/week over the past 6 months.

Exclusion Criteria:

* Presence of any condition that would limit one's ability from exercising (i.e., orthopedic limitations)
* Recent weight gain or weight loss (± 10 pounds within the past 6 months)
* Currently enrolled in a weight loss program
* History of heart disease or diabetes
* Currently taking any medication that would alter heart rate (e.g., beta blocker) or metabolism
* Women who are pregnant, planning on becoming pregnant in the next 2 months, or those pregnant within the past 6 months
* Uncontrolled hypertension (currently taking blood pressure medication or having a resting systolic blood pressure ≥140/90 mmHg
* Get an average of \<6 hours of sleep/night
* Does not currently eat breakfast regularly
* Known food allergies to test foods or states a disliking or unwillingness to eat more than 25% of the buffet foods.
Wheeze Detection in Children During Dynamic Bronchial Situations Measured by WIM-PC™ Recording

The WIM-PC™ device, indicated for acoustic pulmonary function measurement that quantifies the presence of wheezing. This study was designed in order to evaluate the efficacy and safety of using the WIM-PC™ device for wheeze detection during dynamic bronchial situations in infants that were hospitalized as a result of asthmatic attack.

Asthma is the most common cause of hospitalization for respiratory infection in infants under one year of age. About 1-2% of infants with bronchiolitis need to be hospitalized and approximately 8% of these children require intensive care. Pulmonary function tests in infants are objective, but require sedation, which is problematic in acutely ill infants. Wheeze quantification by lung sounds analysis methods is objective, non invasive and has been shown to correlate with clinical status in asthma and bronchiolitis. The recording procedure is simple, requiring only the attachment of 4 ECG-size sensors to the chest wall. A 30-second recording is often adequate, but recording time can be extended as necessary, to obtain good quality data, where wheezes are detected and counted with high degree of accuracy.

Karmel Sonix Ltd has developed the WIM-PC™ device, indicated for acoustic pulmonary function measurement that quantifies the presence of wheezing. This study was designed in order to evaluate the efficacy and safety of using the WIM-PC™ device for wheeze detection during dynamic bronchial situations in infants that were hospitalized as a result of asthmatic attack.

Eligibility Criteria:
Inclusion Criteria:

* Asthmatic or healthy subjects;
* Age up to 18 years;
* Subject or subject's parents/guardian is able to comprehend and give informed consent for participation in the study.

Exclusion Criteria:

* Chest lesions (rush or deformity);
* Hemodynamic instability;
* Concurrent additional major illness.
* Concurrent participation in any other clinical study.
* Physician objection.
Study Assessing Adult Subjects Affected With Upper and/or Lower Limb Spasticity Treated With Botulinum Neurotoxin Type A

The aim of the study is to describe the long term use of Botulinum Neurotoxin Type A (BoNT-A) in adult subjects affected with upper and/or lower limb spasticity who received treatment with BoNT-A for a minimum of three injections cycles at three Italian centers.

The study has a retrospective design and data relating to subjects' injections cycles occurred in the past are collected. Period of observation defined in the protocol is from 2008 to 2018, but it could change for each subject according to the number of injections cycles performed. Time frame for data collection is 12 months from study start.


Eligibility Criteria:
Inclusion Criteria:

* Adult aged ≥18 years old at the time of the first BoNT-A injection
* Diagnosed with spasticity with any cause (excluded CP)
* Treated with a minimum of three BoNT-A treatment cycles for upper limb spasticity (ULS) and/or lower limb spasticity (LLS)
* With follow up data available in the subject's medical record
* Provision of written informed consent form, to the extent required according to applicable national local regulations for a retrospective, non-interventional study

Exclusion Criteria:

* Treatments and assessments were performed at more than one centre
CBD Knee Scope Study

This is a prospective, randomized, nonblinded trial to evaluate the effectiveness of Cannabidiol (CBD) oil on post-operative pain control compared to opioid medications after a knee arthroscopy.

This is a prospective non-blinded randomized controlled trial with 3 groups of subjects all undergoing knee arthroscopy for soft tissue pathology. The first group will receive the SOC opioid course: 7 days of Percocet (oxycodone 5mg-acetaminophen 325mg) every four hours PO PRN, following surgery. the second 100 mg CBD daily for 30 days pre-operatively continuing 30 days post-operatively, and the third group 200 mg CBD daily for 30 days pre-operatively continuing 30 days post-operatively.

All subjects in each of the three groups will undergo standard pre-operative and post-operative care, including physical exams, imaging, and education. They will only differ in pre-operative pain medication administration if they are in one of the two CBD groups. The groups will undergo surveys (sleep quality, self-reported pain, need for refill or switch to opioids). Sleep quality will be assessed with the Insomnia Severity Index (ISI) while pain, need for refill, and switch to opioids will be recorded by the patient on CRF packets. The CRF packets will be given to patients at each visit for them to fill out to the best of their ability.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* requiring knee arthroscopy for soft tissue injury, acute or chronic knee injury
* able to complete surveys and follow-up visits

Exclusion Criteria:

* younger than 18 years of age
* history of knee dislocation, fracture, previous surgery, coexisting extremity pathology, \*pregnancy.
Insulin Secretory Capacity in Insulin-independent Pancreas-Kidney Recipients Compared to Controls

The purpose of this study is to compare functional beta-cell mass using the hyperglycaemic clamp test in insulin-independent pancreas-kidney recipients with that in non-diabetic kidney recipients and normal controls as well as with the partially previously reported data in beta-cell recipients.


Eligibility Criteria:
Inclusion Criteria:

* kidney pancreas recipients
* kidney recipients
* healthy volunteers
* beta-cell recipients
* immunosuppression with MMF-Tacrolimus
* 1-4 years after transplantation

Exclusion Criteria:

* high doses of steroids
* insulin dependent
Surveillance for Early Liver Injuries Caused by Xianlin Gubao Capsule.

This is a prospective registry study to surveil early liver injuries caused by Xianlin Gubao Capsule (XLGB Capsule) through a non-intervention observational way. And attempt to establish a predictive model to screen susceptibilities to XLGB Capsule.

The primary objectives of this study include:

(i) The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Capsule; (ii) The record of overall individuals with demographics, underlying diseases, physical status, medication information, clinical laboratory index, and so on; (iii) The specimen collection of surveiled individuals. (iv) The attempt to establish a predictive model to screen susceptibilities to XLGB Capsule.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals in accordance with indications for XLGB Capsule, including osteoarthritis, and lumbar muscle strain;
2. The age range of 18 to 70 years；
3. Individuals taking XLGB Capsule over 2 weeks;
4. Abnormalities of serum liver biochemistry achieving one of the criteria as follows:

   (i) alanine aminotransaminase (ALT) or aspartate transaminase (AST) ≥2 folds of upper limit of normal (ULN); (ii) total bilirubin (TBiL) ≥ 2 ULN; (iii) alkaline phosphatase (ALP) ≥ 2 ULN;
5. Individuals can provide informed consent form.

Exclusion Criteria:

1. Individuals without indications for XLGB Capsule;
2. Unconformity to the XLGB Capsule drug label;
3. Individual taking XLGB Capsule less than 2 weeks;
4. Individuals taking other hepatotoxic drugs combined with XLGB Capsule, simultaneously;
5. Unconformity to the diagnostic standard for herb-induced liver injury (the Guideline for Diagnosis and Treatment of Herb-induced Liver Injury, RPGIP-2016CN003）.
Analyse of Diagnosis Value of Keloid on 68Ga- FAPI-04 PET-CT

Keloid scars are common benign fibroproliferative reticular dermal lesions. Fibroblasts are considered to be the key cellular mediators of fibrogenesis in keloid scars. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may provide evidence for diagnosis and evaluate the effectiveness of treatment.

Keloid scars are common benign fibroproliferative reticular dermal lesions with unknown etiology and ill-defined management with a high rate of recurrence post-surgery. The progression of keloids is characterized by increased deposition of extracellular matrix proteins, invasion of the surrounding healthy skin, and inflammation.

Fibroblast activation protein alpha (FAP-a) and dipeptidyl peptidase IV(DPPIV) are proteases located at the plasma membrane promoting cell invasiveness and tumor growth and have been previously associated with keloid scars. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment, and follow-up of keloid.

This study aims to explore whether FAP plays a role in the mechanisms of scar tissue progression, as well as the diagnostic efficacy of these two imaging agents, and to be able to evaluate relevant treatments for personalized therapy.

Eligibility Criteria:
Inclusion Criteria:

* suspected or confirmed pulmonary fibrosis patients;
* signed written consent.

Exclusion Criteria:

* pregnancy;
* breastfeeding;
* known allergy against FAPI
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance
Gestational Diabetes and Sleep-Disordered Breathing

This study is designed to evaluate the amount of heart rate variability (HRV) for women with gestational diabetes mellitus (GDM) and to determine whether women with GDM have transient sleep-disordered breathing (SDB) during pregnancy.


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women aged 18-40 years old.
2. Pregnant women at gestational age 30 to 34 weeks.

Exclusion Criteria:

1. Pregnant women with known type 1 or type 2 diabetes mellitus.
2. Pregnant women carrying more than one fetus.
3. Pregnant women with pre-gestational hypertension.
4. Pregnant women with pre-eclampsia during current pregnancy.
5. Pregnant women with a history of coronary artery disease or acute ischemia.
6. Pregnant women who currently smoke.
7. Pregnant women without results for the 3 hour 100 gram oral glucose tolerance test.
8. Pregnant women with preterm labor, cervical shortening, premature rupture of membranes or any other obstetric complications that may predispose to preterm labor.
9. Pregnant women using 17-P (progesterone) to prevent recurrent pre-term labor.
10. Pregnant women with known SDB.