cyrilzakka/clinical-trials huggingface dataset:
Blinding and Previous Experiences of Dry Needling

Dry needling (DN) is a treatment technique widely used in patients with various musculoskeletal health problems due to myofascial trigger points (MTrP). DN has shown to have positive effect on pain and function in patients with mechanical neck pain. These positive results are thought to be the consequence of specific neurophysiological and mechanical processes. Research has shown that DN induces 1) end plate inhibition, 2) reduction of inflammatory substances, 3) increase of blood flow and oxygen and 4) a reduction of nociceptive afferent activity. However, the exact working mechanisms underlying DN effects is still a topic of debate. This trial addresses one of the major methodological issues in needle testing,the effects of proper blinding. DN is a specific technique that is not easily be replaced by another comparable intervention. A sham needle with a blunt tip was created that simulates penetration into the skin without actually doing so. Research about a valid method for the control in needling studies is for this reason of particular relevance. A proper blinding technique is of importance to further the field of DN.

The objectives of this study are to analysize short-term effects on pain intensity and pressure pain sensitivity according to previous experience (blinding) in subjects with mechanical neck pain receiving real or sham-DN and to determine the success in masking DN versus sham DN in patients with mechanical neck pain based on prior experience with this technique.

Eligibility Criteria:
Inclusion Criteria:

* Non-specific mechanical neck pain of at least 3 months of duration
* Between 18-60 years old
* At least one active trigger point in the upper trapezius muscle which referred pain reproduces the neck pain symptoms

Exclusion Criteria:

* whiplash injury;
* previous cervical or thoracic surgery;
* cervical radiculopathy or myelopathy;
* diagnosis of fibromyalgia syndrome;
* having undergone physical therapy in the previous 6 months;
* fear to needles
Retrospective Study of the Protective Effect of Gastrodin on Myocardium in Patients Undergoing Cardiac Surgery

Retrospective collection of Wuhan Union hospital from December 1,2018 to June 30,2021 to meet the entry and discharge standards. The patient 's medical record data were divided into study group and control group according to the use of gastrodin during operation. The perioperative data and prognostic outcomes in the patient 's medical records were collected and analyzed. The degree of myocardial injury and postoperative clinical outcomes were compared between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged≥18 years, regardless of gender;
* Patients undergoing elective cardiac surgery under general anesthesia;
* ASA grade 1 \~ 3.

Exclusion Criteria:

* Suffering from more serious genetic diseases (such as immunodeficiency, thalassemia, etc.);
* Moderate to severe malnutrition, moderate to severe anemia;
* Persistent infection;
* Severe preoperative underlying diseases (such as severe liver and kidney dysfunction)
The Effect of Omega -3 Supplements on the Serum Levels of ACE/ACE2 Ratio as a Potential Key in Cardiovascular Disease and COVID-19; A Randomized Clinical Trial in the Covid-19 Uninfected Jordanian People

The Renin-Angiotensin-Aldosterone System (RAAS) is involved in blood pressure regulation and electrolyte balance. Angiotensin-converting enzyme (ACE) is a critical regulator of RAAS by cleaving angiotensin (Ang1) to Angiotensin2 (Ang2), which is the most powerful biologically active product of RAAS \[1\]. In the same context, angiotensin-converting enzyme 2 (ACE2) converts Ang2 to Ang (1-7), which is a vasodilator, antithrombotic, and antihypertrophic peptide \[2\]. ACE2 which is found in many tissues \[3\] has opposite effects to ACE on the heart, kidneys, and lungs \[4\]. Many pathological conditions, in particular cardiovascular disease (CVD), have shown a link between a disturbance in ACE/ACE2 ratio and the downregulation of ACE2 levels \[5\]. Also, ACE/ACE2 has been reported to be higher in moderate to severe chronic heart failure \[6\] as well as systolic blood pressure \[7\]. Recently, an elevated ACE/ACE2 ratio is linked to Coronavirus disease 2019 (COVID-19). SARS-COV2 enters target cells by binding of the spike protein to ACE2 and a specific transmembrane serine protease 2 (TMPRSS2) for the spike (S) protein priming, which also leads to downregulation of ACE2 \[8\]. Down-regulation of ACE2 caused by Coronavirus may have a potential role in the pathogenesis of COVID-19 infection. Accordingly, people with a higher ACE/ACE2 ratio may be more at increased risk of worse Covid-19 consequences \[9\].

On the other hand, omega-3 fatty acids could decrease CVD risk by their anti-inflammatory anti-thrombotic function \[10\]. A meta-analysis comprising 15,806 patients, showed that omega-3 fatty acids associated with a 30% reduction in fatal myocardial infarction and sudden death, in addition to a 20% reduction in overall mortality \[11\]. To the best of our knowledge, no clinical trials have evaluated the effect of omega-3 supplementation on serum ACE/ACE2 ratio which is recently ascribed as a potential key in 2019 Covid-19 as well as CVD \[5,9\].


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria included males and females in the age range of 35-65 years without a medical diagnosis of COVID-19 infection.

Exclusion Criteria:

* Any subject with any chronic disease such as CVD, diabetes, or immune problems, including autoimmune diseases, chronic or severe infections was excluded.
* Pregnant, breastfeeding, and females using hormonal contraceptives were excluded.
A Trial to Evaluate the Safety and Preliminary Efficacy of iMesenchymal Stromal Cells(iMSC) in Subjects With SR-aGVHD

A study to evaluate the safety and preliminary efficacy of iMSC in subjects with SR-aGVHD

A single center, open label, dose escalation study to evaluate the safety,tolerability and preliminary efficacy of iMSC in subjects with SR-aGVHD

Eligibility Criteria:
Inclusion Criteria:

1.Subjects who understand and voluntarily sign the Informed Consent Form(ICF); 2.4-70 years; 3.Subjects with SR-aGVHD; 4.ECOG≤2; 5.Subjects with II to IV grades of steroid hormone resistance;

Exclusion Criteria:

1. Accepted systemic or local treatment of mesenchymal stem cells;
2. Have severe allergy to blood products or have allergy history of heterologous protein;
3. Expected survival period within 3 months;
4. Alanine transaminase(ALT)or Aspartate aminotransferase(AST)\>2\*upper limit of normal(ULN);Creatinine clearance rate≤30ml/min or Blood Urea Nitrogen(BUN)\>2\*upper limit of normal(ULN), International Normalized Ratio (INR)\>1.5\*upper limit of normal(ULN);
5. Have severe hepatic veno-occlusive disease(HVOD);
6. Have severe lung disease like severe lung infection;
7. Have history of severe acute myocardial infarction or have uncontrolled angina pectoris,arrhythmia and severe heart failure;
8. Proved having resistant hypertension within 6 months before enrollment;
9. Have active thrombus;
10. Have untreated or uncertain active solid tumors within 5 years;
11. Have alcohol or drug addiction or with a clear history of mental disorders or with a history of drug abuse or drug use of psychotropic substances;
12. Human immunodeficiency virus(HIV)antibody positive, treponema pallidum (TP) antibody positive;
13. Have active hepatitis B or hepatitis C;
14. Have gastrointestinal symptoms which not caused by GVHD
15. Pregnant or lactating female subjects, or subjects who are unable to comply with contraceptives from the study period to 6 months after the end of this study;
16. Subjects who have participated in other clinical trials and have used other study products within 12 weeks before screening;
17. Not suitable for this clinical trial for other reasons.
The Efficacy and Safety of Early Vitamin AD Supplementation in Very Preterm Infants

Bronchopulmonary dysplasia (BPD) is the most prevalent longterm morbidity among surviving extremely preterm infants and has a multifactorial etiology. BPD is associated with later risk of reactive airways disease, such as asthma, post neonatal mortality and adverse neurodevelopmental outcomes.Retinopathy of prematurity (ROP) is a common retinal neovascular disorder and a major cause of vision impairment or blindness in preterm infants, even with aggressed current standard care.Accumulating epidemiologic evidence suggests that vitamin D (VD) deficiency or insufficiency is associated with respiratory disease and metabolic bone disease in premature children.Vitamin A (VA) plays an integral part in lung growth and differentiation. VA is an essential micronutrient for normal visual function.

Our prospective double-blinded randomized controlled trial will include infants born at \<32 weeks' gestation and admitted to six tertiary NICUs in China. Infants in the intervention (vitamin AD drops) group will receive the daily dose VA at 1500 IU/day with VD 500 IU/day, added to their enteral feeds in drop form as soon as minimal feeding was introduced, and continued to 28 days or discharge. Infants in the control group will receive an equivalent volume of a placebo solution. Following informed consent, enrolled infants will be randomly allocated to the control or VAD group. The primary outcome is bronchopulmonary dysplasia (BPD) , ROP, or metabolic bone disease and the secondary outcomes are mortality; NEC ≥ stage 2; ; late-onset sepsis; weight gain, change in weight, increase in length, increase in head circumference; time to full enteral feeds; and number and type of critical incident reports.


Eligibility Criteria:
Inclusion Criteria:

* gestational age\<32 weeks,
* \<96 hours of age

Exclusion Criteria:

* genetic metabolic diseases;
* congenital major abnormalities;
* congenital non-bacterial infection with overt signs at birth;
* terminal stage of illness (pH \< 7.0 or hypoxia with bradycardia\>2 h);
* ≥ grade III intracranial hemorrhage;
* lacking parental consent.
Influenze of Approach in Reversed Shoulder Prosthesis

To determine the differences in the placement of the glenoid implant of the inverted prostheses when they are implanted using a superior approach and using an anterior approach.

Inverted prostheses have proven to be effective in the treatment of all those pathologies that involve a deterioration of the rotator cuff (secondary arthropathy, acute fractures, sequelae of fractures, tumor surgery and revision surgery). Despite this, numerous complications have been described after the use of inverted prostheses, such as glenoid erosion, infections, dislocation, or aseptic loosening. The most frequent complication related to the use of inverted prostheses is glenoid erosion that can occur in up to 96% of cases. This complication appears early in the evolution, usually before 2 years after surgery. Its clinical significance is not yet clear, but it seems that it may be a cause of long-term prosthetic loosening. To avoid the development of glenoid erosion, the best option is to place the glenoid component low, so that if the glenoid component is flush with the lower margin of the glena, the chances of developing glenoid erosion are significantly reduced. Two types of approaches have been used to implant these prostheses, the deltopectoral and the superior anterior approach. Each of them has its advantages and disadvantages, so that deltopectoral seems to improve surgical exposure and therefore favors the best placement of the glenoid component, but sacrifices the subscapularis tendon, increasing the risk of dislocation of the components. On the contrary, the superior anterior approach respects the subscapularis tendon, reducing the risk of dislocation of the components but gives worse surgical exposure.

Eligibility Criteria:
Inclusion Criteria:

* Patients with secondary osteoarthritis of the shoulder who are candidates for an inverted prosthesis
* Acute fractures \<2 weeks of evolution in patients candidates for inverted prostheses
* No previous surgeries of the affected shoulder
* Acceptance by the patient to participate in the study

Exclusion Criteria:

* Fractures\> 2 weeks of evolution
* Previous surgeries on the affected shoulder
* Not signing the informed consent
* Cognitive impairment
* Institutionalization of the patient
A Study of the Impact of Digital Intervention on Parents/primary Caregivers' Myopia Prevention and Control Health Literacy on Preschoolers' Myopia and Physical and Mental Health

The study is a Randomized controlled trial based on digital interventions, involving pre-school children and their parents or major caregivers. To compare the myopia and physical and mental health status of preschool children before and after intervention between intervention group and control group, to confirm the effect of digital intervention on prevention and control of Myopia and physical and mental health of preschool children.

In this study, wechat, online courses, live broadcast and SMS were used to transfer the knowledge of myopia prevention and control to parents/primary caregivers, and to promote their attitude and behavior change. The intervention period was from October to December 2025. The control group did not 2024 any intervention. The prevention and control of Myopia and health literacy of the parents and main adopters were collected at baseline and after the intervention respectively, visual data and physical and mental health status of preschool children were collected every six months.

Eligibility Criteria:
Inclusion Criteria:

* No cognitive impairment and communication impairment
* Volunteer and sign the informed consent
* Fill in the questionnaire
* Skilled in using electronic equipment

Exclusion Criteria:

* Children with congenital glaucoma, cataract, strabismus and other congenital eye diseases
* Children with a history of ocular trauma, eye surgery, or complications of myopia
* Do not cooperate with the investigation
A Chronic Obstructive Pulmonary Disease (COPD) Trial Investigating Roflumilast on Safety and Effectiveness in China, Hong Kong and Singapore:

The aim of this trial is to determine the efficacy, safety and tolerability of 500 µg Roflumilast tablets once daily in patients with COPD in China, Hong Kong, and Singapore.


Eligibility Criteria:
Main Inclusion Criteria:

* Willingness to sign a written informed consent
* Chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2009
* Chinese or Malay or Indian ethnicity
* History of chronic obstructive pulmonary disease symptoms for at least 12 months prior to baseline visit V0
* Forced expiratory volume in the first second/ Forced vital capacity (FEV1/FVC) ratio (post-bronchodilator) \< 70%
* Forced expiratory volume in the first second (FEV1) (post-bronchodilator) \< 50 % of predicted
* Former smoker (defined as: smoking cessation at least one year ago) or current smoker both with a smoking history of at least 10 pack years

Main Exclusion Criteria:

* Moderate or severe COPD exacerbation and/or COPD exacerbations treated with antibiotics not stopped at V0
* Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit V0
* History of asthma diagnosis in patients \< 40 years of age or relevant lung disease other than COPD
* Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the baseline visit V0
* Known alpha-1-antitrypsin deficiency
Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis

This trial was conducted in the United States of America (USA). This trial aimed for a comparison between the effect of two different doses of estradiol on parameters related to efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy
* Postmenopausal
* Hysterectomized or non-hysterectomized
* Moderate or severe vaginal dryness and soreness

Exclusion Criteria:

* Known, suspected, or past history of breast cancer
* Known, suspected, or past history of hormone-dependent tumor
* Genital bleeding of unknown etiology
* Acute thrombophlebitis or thromboembolic disorders or a past history of these conditions, associated with previous estrogen use
* Vaginal infection
* Use of exogenous corticosteroids or sex hormones within 8 weeks of starting active treatment in study
* Use of vaginal, oral or vulvar homeopathic preparations within seven days of starting active treatment in study
* History of treatment with diethylstilbestrol
Vacant Lot Greening and Violence-Related Outcomes

The purpose of this study is to determine the impact of vacant lot greening on perceptions of safety and violence for residents living around the lots. We hypothesize that people living around lots that are greened will have improved perception of safety.

Violence is a serious health problem in the US, and especially in Philadelphia, as the city ranks first in violent crime amongst the ten largest US cities. The determinants of violent crime range from individual to community level factors. In this study, we focus on physical incivilities in the built environment, specifically vacant lots, as they have been associated with violent crime. Physical incivilities are also associated with individual perceptions of crime and safety, and subsequently, negative health outcomes. However, prior research has been observational and retrospective. We aim to expand this body of work through a randomized community intervention trial of vacant lot greening to explore causal mechanisms between vacant lots and violent crime outcomes. This pilot study, in partnership with the Pennsylvania Horticultural Society, will investigate the feasibility of a vacant lot greening intervention, and explore how vacant lot greening changes resident perception about violence, fear, stress, and neighborhood disorder, as well as violent crime in the surrounding area. We will interview residents living around the greened and non-greened lots during a joint walk around a pre-determined route, which will ensure exposure to our intervention. We will also use violent crime data (homicide, aggravated assault, robbery, and rape) from the Philadelphia Police Department. Results of this pilot trial will be used to develop a full scale vacant lot greening grant to be submitted to the National Institutes of Health or the National Institute of Justice.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Lives in home
* Ability to walk unassisted and without difficulty for 10 blocks

Exclusion Criteria:

* One resident per house
Orthokeratology for Keratoconus

To investigate a possible benefit of Orthokeratology contact lenses to improve uncorrected visual acuity of keratoconus patients


Eligibility Criteria:
Inclusion Criteria:

* Moderate Keratoconus
* No apical scars

Exclusion Criteria:

* Advanced Keratoconus
* Apical scaring
* Contact lens intolerance
Bacterial Reduction and Post Operative Endodontic-pain Using Different Kinematics

This study was conducted to compare the antibacterial effect and degree of postoperative pain of single rotary and reciprocating file systems during endodontic therapy

Introduction: Instrumentation kinematic is one of the many aspects of shaping files that underwent heavy development through the last decade. The impact of the type of motion used to drive shaping instruments was heavily studied but mostly in-vitro. More randomized clinical trials are needed to achieve a reliable body of data concerning the issue.

Aim: This study aimed to evaluate the effect of varying shaping files' kinematics on bacterial reduction, post-operative pain and the incidence of flare-ups. Methods: Necrotic, asymptomatic, single-rooted mandibular premolars with single canals were used in the study, where 46 patients were randomly allocated to two groups. In the first group, WaveOne Gold was used for mechanical preparation while One Shape was used in the second group. Samples were taken preoperatively (S1) and after chemomechanical preparation (S2). Bacterial reduction was evaluated and compared between both groups via culturing technique and quantitative analysis by real-time polymerase chain reaction (qPCR). Post-operative pain and the incidence of flare-ups were also evaluated using the visual analog scale (VAS) method.

Eligibility Criteria:
Inclusion Criteria:

* mandibular premolars
* single rooted
* single canalled
* necrotic pulps
* asymptomatic apical periodontitis

Exclusion Criteria:

* gross caries
* root/crown fracture
* sinus tract
* swelling
* intake of antibiotics within previous 3 months
* pain with percussion
Assessment of a Pre-Workout Supplement

This study is assessing the effects of a pre-workout dietary supplement.

The purpose of this study is to examine the acute effects of a pre-workout dietary supplement at a standard dose and one that is delivered at 150% of the standard dose on energy metabolism, cardiovascular hemodynamics, blood metabolites and mental focus.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be apparently healthy males and/or females between the ages of 18 and 40
* Participants must have at least 6 months immediate prior history of resistance training including the bench press and leg press/squat

Exclusion Criteria:

* Participants who have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmias and/or cardiovascular disease
* Participants who currently use any prescription medication
* Participants who are intolerant to caffeine and/or other natural stimulants
* Participants who are pregnant or lactating women
* Participants who have a history of smoking
* Participants who drink excessively (12 drinks per week)
An Observational Study to Assess Ubrogepant Tablets and Atogepant Tablets to Treat Migraine in Adult Participants

Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will evaluate how effective the use of ubrogepant and atogepant is in treating adult participants with migraine.

Urogepant (Ubrelvy) and Atogepant (Qulipta) are approved drugs for treatment of migraine in adults in the US. Approximately 200 adult participants who are prescribed Ubrogepant or atogepant by their doctors will be enrolled in this study in Israel.

Participants will receive ubrogepant oral tablets or atogepant oral tablets as prescribed by their physician. Participants will be followed for 90 days.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of migraine according to the ICHD-3 upon judgement of the treating physician
* The patients should be naive to the designated treatment
* Ability to fill an e-diary app

Exclusion Criteria:

* Patients who cannot be treated with UBRO or ATO according to the applicable approved label
* Patients participating in a concurrent clinical interventional study or within the last 30 days
* Patients who were previously treated with rimegepant will be excluded from the study