cyrilzakka/clinical-trials huggingface dataset:
Brief Mindfulness-based Intervention for Indonesian Teacher in Rural Area

A randomized controlled trial to assess the effectiveness of the brief mindfulness on teachers' perceived stress and their psychological well-being.

Teacher in early childhood education (ECE) in Indonesia is experiencing high intense stress due to work environment, class management, child behaviour problem, and lack administrative support. Stress has also shown negatively impact their psychological well-being, quality of teaching, and to children's' executive function. Research about stress and the effects on teacher well-being is especially lacking for rural schools. They represent a forgotten minority and thus, teacher from rural area need a prompt and direct support in terms of stress management strategies.

This study employs a randomized wait-list controlled trial design (RCT) with an assessment before and after treatment. 4-weeks brief mindfulness-based protocol will be given to 40 teachers as experimental group. 40 other teachers receive wait-list treatment will assign as control group. Measurement of perceived stress level will be using Indonesian version of Perceived Stress Scale (PSS), psychological wellbeing will be measure using Indonesian Well-being Scale (IWS), and mindfulness traits will be measure using Indonesian version of Five Factor Mindfulness Questionnaire (FFMQ). Data analysis using MANOVA and ANOVA to measure the differences between groups and within groups for all tests and constructs measured.

Eligibility Criteria:
Inclusion Criteria:

* minimum two years of work experience as early childhood education teacher.
* minimum 25 years of age.
* scoring Moderate (total score 14-26) to High (total score 27-40) perceived stress on PSS-10

Exclusion Criteria:

* have received any formal / manualized mindfulness training prior.
* have ever been diagnosed with chronic stress or other related mental disorders such as anxiety, depression, PTSD.
* people with a history or tendency to commit suicide.
* people with addictive substance dependence who are recovering less than one year.
Prevention and Treatment of Differentiation Syndrome in Patients With Acute Promyelocytic Leukemia

With the introduction of all-trans-retinoic acid (ATRA) and arsenic,the outcome of patients with acute promyelocytic leukemia (APL)has been improved considerably over the last decades.However，early deaths (EDs), mainly due to APL-specific coagulopathy, differentiation syndrome (DS)emerge as a major threat to APL patients.We observe and evaluate the effectivity of induction therapy in patients with APL. Administrate intravenous dexamethasone to prevent or preemptive treat DS. Assess the efficacy and safety of ruxolitinib as second treatment in patients with severe DS with no respond to dexamethasone.Furthermore，the changes of spectrum of cytokines are monitered to find the relationship between the cytokines and the severity of DS.

Adults ages 18-75 with primary acute promyelocytic leukemia.

Design:

The induction therapy with ATRA 25mg/m2/d and ATO 10mg/kg/d should be started as soon as the diagnosis of APL confirmed.

Intravenous dexamethasone at a dose of 5-20 mg daily must be started if the WBC count greater than 5e+9/L (before or during the treatment with ATRA) as prevention or preemptive therapy of DS.

Idarubicin (4-10 mg/m2 /d\*3d) and hydroxyurea（1.0-3.0g/d）can be given as leukocyte lowering therapy which may lessen the risk of DS.

When the progression of clinical symptoms of DS with no response to dexamethasone,ATRA must be stopped and ruxolitinib (5-20mg /d) should be administrated to reduce the production of cytokines.

Participants should stay in the hospital during the treatment for about 4 weeks.

The changes of spectrum of cytokines are monitored to discover the potential relationship between the cytokines and the severity of DS.

Participants will visit every 1 months after CR for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of primary acute promyelocytic leukemia.
* ECOG score≤3.
* Must be able to understand and willing to participate in the study and sign the informed consent.

Exclusion Criteria:

* Refractory/secondary acute promyelocytic leukemia.
* Severe complications such as myocardial infarction, chronic cardiac insufficiency, hepatic failure, renal insufficiency, etc.
* Clinically uncontrolled active infections.
* Malignant tumors with other progresses.
* Ecg: QT interval \> 450 ms.
* Allergic to arsenic agent.
* Pregnant or lactating women.
Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

The purpose of this study is to determine whether the prophylactic ipsilateral central lymph node dissection is equally effective in the management of papillary thyroid microcarcinoma(PTMC) to the bilateral central lymph node dissection.

The extent, the advantage and disadvantage of prophylactic central lymph node dissection was not fully established up to now in papillary thyroid microcarcinoma.

Prophylactic bilateral central lymph node dissection can give a important clinical information about the status of lymph nodes, and possibly guide a further adjuvant treatment. However, it causes high postoperative morbidity, including hypocalcemia and hoarseness. In this respect, some advocate no central lymph node dissection in prophylactic settings.

Thus, we aimed to prove the efficacy of prophylactic ipsilateral central lymph node dissection in thyroid papillary microcarcinoma, compared to the bilateral dissection and no dissection.

Type of Study design: Prospective randomized, controlled double-blinded (to subjects and observers) study.

Group I: Limited/ipsilateral central lymph node dissection (UniCND) Group II: Comprehensive/bilateral central lymph node dissection (BiCND) Group III: No central lymph node dissection (NoCND)

Outcomes: vocal cord palsy, hypocalcemia, locoregional recurrence, distant metastasis

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 70
* Sonographically node-negative cytology confirmed thyroid papillary carcinoma
* Tumor size less than 1 cm in sonography
* Tumor confined to the one lobe of the thyroid gland
* One who provides the informed consent

Exclusion Criteria:

* History of radiation treatment to head and neck area
* History of other malignancy except thyroid cancer
* Poor performance status (ECOG 3-4)
A Trial of SHR0410 Injection for the Treatment of Pain After Endoscopic Surgery of the Lower Abdominal

The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after endoscopic surgery of the lower abdominal.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Subjects requiring elective general anesthesia endoscopic surgery of the lower abdominal
3. Male or female
4. Meet the body mass index standard
5. Conform to the ASA Physical Status Classification

Exclusion Criteria

1. Subjects with a history of difficult airway
2. Subjects with a history of mental illness
3. Subjects with a history of cognitive impairment epilepsy
4. Subjects with a history of myocardial infarction or unstable angina pectoris
5. Subjects with atrioventricular block or cardiac insufficiency
6. Subjects with a history of ischemic stroke or transient ischemic attack
7. Subjects with poor blood pressure control after medication
8. Subject with a history of substance abuse and drug abuse
9. Abnormal values in liver function
10. Subjects with an oxygen saturation below 90% on room air
11. Allergic to drugs that may be used during the study
12. Pregnant or nursing women
13. No birth control during the specified period of time
14. Participated in clinical trials of other drugs (received experimental drugs)
15. The investigators determined that other conditions were inappropriate for participation in this clinical trial
Assessment of Return to Work and Functional Results of French Military Personnel After Ankle Ligamentoplasty

In the general population, ankle sprains are one of the most common injuries, accounting for approximately 20% of all sports injuries and the most frequent reason for trauma consultation (4 to 7% of admissions to emergency departments in France).

The most frequent complication after an episode of ankle sprain is the development of chronic ankle instability (5 to 40% of the patients). Chronic ankle instability is defined by a history of at least one significant ankle sprain with subsequent perception of an abnormal ankle by the patient, associated with various symptoms including: recurrent sprains, repeated episodes of ankle "slippage", pain, episodes of swelling, difficulty and apprehension when walking on uneven surfaces with a decrease in the functional capacity of the ankle or restriction of activity.

In the military population, ankle sprains account for 18.60% of on-duty injuries, and epidemiologic studies report an incidence of 45.14 to 58.40 sprains per 1,000 person-years.

A 2019 study in a population of French military paratroopers found a prevalence of chronic ankle instability of 43.1% after an ankle sprain.

Chronic ankle instability leads to a loss of operational skills in French soldiers, since it results in a score of 4 for the letter "I" (pelvic girdle and lower limbs) in the SIGYCOP military medical profile. The treatment of chronic ankle instability after failure of rehabilitation consists in ligamentoplasty, conservative or not, in order to restore an external ligament plane and stabilize the ankle. For open techniques, the median time to return to sport after ligamentoplasty is 4.7 months. In the series by Lee et al, which studied more specifically the return to sport in high-level athletes, 83.3% of athletes had returned to competitive sport at 4 months and 100% at 8 months. Management of chronic ankle instability by ligamentoplasty may allow the soldier to regain his operational ability (SIGYCOP score I=2).


Eligibility Criteria:
Inclusion Criteria:

* Military personnel,
* Primary ankle ligamentoplasty surgery between January 2015 and December 2021,
* Sufficient French language reading/writing level (elementary school level).

Exclusion Criteria:

* Ankle ligament surgery after a first failure.
A Virtual Reality Brief Violence Intervention: Preventing Gun Violence Among Violently Injured Adults

The overall aim of the proposed project is to develop and evaluate the effectiveness of Brief Violence Intervention-Virtual Reality (BVI-VR) for reducing firearm-related violence, re-injury, and mortality among victims of violence. Outcome measures of firearm-related violence will come from multiple sources, including criminal background checks, hospital data, state-level data, semi-structured clinical assessments, and self-report assessments. In addition, the study aims to understand the impact of BVI-VR on psychosocial mediators resulting in a reduction of firearm-related violence. This will include self-report surveys, neurocognitive assessments, and clinical assessments. The economic efficiency of BVI-VR as a firearm-related violence intervention will also evaluated. To achieve these aims, a randomized control trial (RCT) in a large sample of violently injured adults (18+ years) from VCU Health will be conducted.

Brief Violence Intervention-Virtual Reality (BVI-VR) is being developed as a hospital-based brief gun violence intervention program founded on the principles of positive psychology, motivational goal setting (via gameplay), psychoeducation, cognitive-behavioral therapy, and dialectical behavioral therapy. This proposal will develop five steps to create a 30-minute brief firearm-related violence intervention. The five steps address a range of psychosocial risk factors and enhance protective factors for violence, as well as psychoeducational programming specifically addressing the risk of firearm violence. All steps of the BVI-VR emphasize being in control of making positive choices, and how to locate and leverage opportunities within their communities to improve their well-being. BVI-VR empowers patients to be the driver of their well-being.

Eligibility Criteria:
Inclusion Criteria:

* violently injured patients from VCU's Level 1 Trauma Center
* 18 years or older
* English-speaking

Exclusion Criteria:

* Under 18 years old
* Not a victim of Violent crime
A Prospective Multicenter Study of Different Surgical Methods in the Treatment of High Myopic Macular Schisis

In view of the current problem of treating high myopic macular schisis, the main purpose of our study is to find out the most appropriate time of surgical intervention, to compare the effectiveness and safety of various surgical methods in the treatment of high myopic macular schisis, and to find out the advantages and disadvantages of each surgical method in the treatment of MF. As well as the outcomes and complications of long-term follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. diopter ≤-6.00D or axial length ≥ 26.00mm;
2. OCT showed macular schisis with or without macular retinal detachment;
3. agreed to participate in this project and signed informed consent form.

Exclusion Criteria:

1. OCT confirmed full-thickness macular hole with or without macular retinal detachment；
2. submacular active or inactive CNV;
3. previous vitreoretinal surgery and anti-glaucoma surgery；
4. with rhegmatogenous retinal detachment, ocular trauma, glaucoma, corneal opacity and other ophthalmic diseases;
5. complicated with severe systemic disease can not tolerate surgery or follow-up;
6. do not agree to participate the project or disagree with the follow-up.
The Use of Irvingia Gabonensis (Bush Mango)and Cissus Quadrangularis to Reduce Weight and Blood Lipids

Hypothesis: Cissus quadrangularis as well as Irvingia gabonensis are used in weight management and related conditions. This study set out to investigate if a combination of the two could have additional benefits to overweight and obese people.

To assess and compare the effects of administration of Cissus quadrangularis (Linn) and a Cissus quadrangularis /Irvingia gabonensis combination on body weight blood pressure, fasting blood glucose, plasma total and LDL cholesterol in 72 overweight and obese subjects.

The study was a 10 week randomized, double-blind, placebo-controlled design, involving 72 obese or overweight participants. Participants were randomly divided into three groups (24 participants/ group):

Group 1 - Placebo; Group 2 - Cissus quadrangularis (CQ); Group 3 - Cissus quadrangularis and Irvingia gabonensis (CQ-IG).

The placebo (250mg) or active formulations ((150 mg CQ and 250 mg CQ-IG) were administered twice daily before meals. Weight as well as fasting blood was taken at baseline, and at 4, 8 and 10 weeks.

No major dietary changes or exercises were suggested during the study.

Eligibility Criteria:
Inclusion Criteria:

* BMI\>26kg/m2

Exclusion Criteria:

* Diabetics
* Pregnant and lactating
* Subjects on any other weight loss program
* Following any specific low calorie diet
INTRAOCULAR PRESSURE MEASUREMENT AT the END of PARS PLANA VITRECTOMY

Intraocular pressure is measured regularly at any and all visits with your eye doctor or optometrist.

The purpose of this study is to compare measurements of eye pressure at the end of the surgery, comparing the ability of a gloved finger or sterile cotton-tipped applicator ("Q-tip") to accurately measure intraocular pressure against a standardized instrument designed for this purpose.


Eligibility Criteria:
Inclusion Criteria:

1. All patients undergoing Pars Plana Vitrectomy between June 25, 2024 - and December 30, 2024, will be included.
2. Patients aged 18 years or older
3. Patients able to give informed consent

Exclusion Criteria:

1. Patients with complicated Pars Plana Vitrectomy (choroidal hemorrhage, retrobulbar hemorrhage)
2. Patients with irregular cornea surface will be excluded (keratoconus, band keratopathy, corneal edema, corneal transplant, cornea scarring)
3. Patients undergoing combined scleral buckling at time of surgery
4. Patients with previous glaucoma filtration surgery (ie. trabeculectomy or tube shunt surgery)
NeuroPath Comparative Validation Study Plan

The purpose of the study is to compare the performance of the NeuroPath automated nerve conduction test with the standard of care manual test in the diagnosis of entrapment neuropathies.


Eligibility Criteria:
Symptomatic Inclusion Criteria:

* sensory symptoms (numbness and/or tingling) in at least 2 of digits 1,2,3 and 4, in at least one hand, for at least 1 month, prior to the start of the clinical study. The sensory symptoms may be intermittent or constant, but if constant, there must have been a period of time during which the symptoms were intermittent. The numbness and tingling may be accompanied by pain, but pain alone is not sufficient to meet this first inclusion criteria.
* Sensory symptoms (numbness and/or tingling) aggravated by at least 1 of the following: sleep, sustained hand or arm positioning, or repetitive actions of the hand.
* Sensory symptoms (numbness and/or tingling) mitigated by at least 1 of the following: changes in hand posture, shaking the hand, or use of a wrist splint.
* If pain is present, the wrist, hand, and finger pain is greater than elbow, shoulder, or neck pain if there is pain in any or all of those locations.

Symptomatic Exclusion Criteria:

* Sensory symptoms exclusive or predominatly in the little finger (D5) (ulnar neuropathy).
* Neck pain or shoulder pain preceded the paresthesia in the digits (cervical radiculopathy and/or brachial plexopathy).
* Numbness and/or tingling in the feet that preceded or accompanied the sensory symptoms in the hands (polyneuropathy).
* Medical history and physical examination that indicates an explanation for the sensory symptoms which is more probable than CTS. For example, digital neuropathy, median nerve pathology proximal to the carpal tunnel, ulnar neuropathy, radical neuropathy, brachial plexopathy, cervical radiculopathy, spinal cord, brainstem or brain pathology, or a polyneuropathy.
* Absence of 1st, 3rd, 4th or 5th digits
* Open wounds at the measurement sites
* Excessive sensitivity to electrical stimulation
* Median nerve injection in the past 30 days
* Prior carpal tunnel surgery
* Patients who are susceptible to radio frequency noise - such as patients with pacemakers or patients that have electrical stimulators of any sort.

Control Subject Inclusion Criteria:

* Normal neurological examination

Control Subject Exclusion Criteria:

* Absence of 1st, 3rd or 5th digits
* Open wounds at the measurement sites
* Excessive sensitivity to electrical stimulation
* Median nerve injection in the past 30 days
* Prior carpal tunnel surgery
* Reported history of CTS, polyneuropathy, diabetes,renal failure, thyroid disease or Vitamin B 12 deficiency
* Patients who are susceptible to radio frequency noise-such as patients with pacemakers or patients that have electrical stimulators of any sort.
Effects of Taping on Pregnancy-related Back Pain

Back pain during pregnancy is common with up to 90% of pregnant women experiencing either low back pain (PLBP), pelvic girdle pain (PGP) or a combination of both pains. Although pregnant women seek out various forms of pain relief methods such as pain medication, exercise, education, pelvic support belts, and chiropractic treatments, there is limited evidence with regards to the efficacy of these treatments. Recently manual therapists, such as chiropractors, have used tape in an effort to relieve pain from musculoskeletal injuries with varying results. In the pregnant population, there have been limited studies to date on the role of taping and pregnancy-related back pain and none of this research delineates the efficacy of tape with respect to the 3 pain patterns experienced by pregnant women.

This study is a randomized control trial with 3 main parts associated. 1) Initial visit: Potential participants will be recruited from 2 antenatal clinics at the participating hospital. A person from the circle of care will ask if they are interested in participating in a study regarding pregnancy-related LBP. Participants are pre-screened by a research investigator, If patients meet the eligibility criteria, they will be invited to participate. Research personnel will explain the study in full including the rationale (per the Project Consent Form), visit requirement, treatment protocol and follow-up. Once consent is obtained, a Pre-Visit Questionnaire will be administered while they are awaiting their antenatal appointment. 2) Physical exam and treatment: Following their appointment, research personnel will walk the participant to the Obstetrical Day Unit where the chiropractor will review the consent and questionnaire, perform a brief physical exam to ensure proper stratification of pain, randomized the participant (as pre-determined by the biostatistician) and apply the appropriate taping protocol (intervention vs sham). 3) Follow-up: Five to 7 days later, research personnel will follow-up with the participant by phone and administer a questionnaire pertaining to their experience with the taping protocol. The total visit should take no more than 30 minute

Eligibility Criteria:
Inclusion Criteria:

* Healthy females of childbearing age
* Currently experiencing a healthy, singleton pregnancy and are at 28 weeks of gestation or later
* Proficient competency in the English language

Exclusion Criteria:

* Does not wish to participate
* Carrying multiples
* Inability to understand the questionnaire due to a lack of understanding of the English language
* Allergy to tape and/or adhesives (acrylic copolymer)
* Prior spinal surgery
* A known and current disc pathology
Safety and Efficacy of MP-424 to Treat Chronic Hepatitis C

The purpose of this study is to assess the efficacy and safety after administration of MP-424 to patients with chronic hepatitis C.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with genotype 1b chronic hepatitis C
* Patients naive to the concomitant medications with interferon

Exclusion Criteria:

* Patients diagnosed with decompensated cirrhosis
* Patients diagnosed with positive HBs antigen in the test
Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients

The purpose of this study is to ascertain whether Arotinolol Hydrochloride reduces mortality and cardiovascular events in chronic kidney disease stage 5 patients with hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-75 years-old;
* Chronic kidney disease stage 5 with haemodialysis treatment for 2 months;
* Patients with blood pressure≥140/90 mmHg after receiving 2 or 3 antihypertensive medications for 2 weeks;
* Patients who receiving alfa or beta blockers will be washed out for 2 weeks;
* Written informed consent

Exclusion Criteria:

* Unstable angina, myocardial infarction, symptomatic or continuous arrhythmia, cardiosurgery in the last 2 months;
* Patients who taking class I antiarrhythmic drugs;
* Resting heart rate less than 60;
* Patients with systolic pressure less than 90 mmHg;
* Patients with chronic obstructive pulmonary disease and asthma;
* Patients with cerebral infarction in the last 2 weeks;
* Severe disorders of liver function;
* Allergy to the arotinolol;
* Patients who planning to have kidney transplantation in the near future;
* Pregnancy and breast-feeding;
* Malignant tumor