cyrilzakka/clinical-trials huggingface dataset:
The Relationship of Cervical Sagittal Parameters With Pain and Disability in Cervical Myofascial Pain Syndrome

Participants between the ages of 18-64 who were diagnosed with cervical myofascial pain syndrome will be included in the study. cervical sagittal parameters, numerical pain rating scale, Bournemouth neck questionnaire and cervical range of motion will be measured and evaluated.

It is an observational, cross-sectional study. Participants between the ages of 18-64 who were diagnosed with cervical myofascial pain syndrome, who applied to the Physical Medicine and Rehabilitation Clinic of Kanuni Sultan Süleyman Training and Research Hospital with neck pain for more than 3 months will be included. The pain level of the participants will be evaluated with the numerical pain rating scale, the cervical range of motion and the disability level with the Bournemouth neck questionnaire. C0-2 cervical lordosis angle, C2-C7 cervical lordosis angle, cervical sagittal vertical axis (cSVA), T1 slop, T1 slop - cervical lordosis angle (TS-CL), cervical tilt, thoracic inlet angle (TIA) and Cranial tilt measurement will be performed by using Surgimap software program. The relationship between the level of pain and disability, and cervical sagittal parameters will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age at 18-64 years
* Neck pain due to myofascial pain syndrome for more than 3 months
* Presence of lateral cervical radiograph taken in neutral position in the last 3 months
* Visible lower border of T1 vertebra on lateral radiographs
* Absence of other spinal pathologies such as underlying scoliosis, cervical disc herniation, spondylolysis, spondylolisthesis

Exclusion Criteria:

* Presence of an organic pathology that will cause neck pain
* Inability to see the lower border of the T1 vertebra on lateral cervical radiographs and the radiographs not taken in neutral position
Risk Factors,PREvention and OutComes for CI-AKI in PatientS undErgoing PCI at Intensive Care Unit(PRECISE-ICU)

A retrospective, observational study included all consecutively critically ill patients undergoing percutaneous coronary intervention(PCI) at intensive care unit (ICU) in Fujian Provincial Hospital from January 1st 2012 to December 31st 2018. The aim was to determine the incidence,risk factors,prophylactic strategy and outcomes of CI-AKI in critically ill patients undergoing PCI.


Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients undergoing PCI at ICU

Exclusion Criteria:

* pregnancy
* lactation
* end-stage renal disease (eGFR \<15 mL/min/1.73 m2)
* long-term dialysis treatment
* intravascular administration of contrast medium within the last 7 or 3 days postoperatively
Registry of Patients Undergoing Cryoablation for Early Stage Breast Cancer

This study evaluates the side effects and outcomes of patients who undergo cryoablation for early stage breast cancer.

PRIMARY OBJECTIVE:

I. To obtain observational real-life data of patients who choose this non-conventional treatment and to follow their outcomes.

OUTLINE: This is an observational study.

Patients have their medical records reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cryoablation for breast cancer
First in Human Study to Evaluate the Safety and Tolerability of GEM103 in Geographic Atrophy Secondary to Dry Age Related Macular Degeneration

The study is designed to identify the maximum tolerated dose (MTD) for intravitreal (IVT) administration of GEM103 in subjects with geographic atrophy (GA) secondary to dry AMD. Safety and tolerability of a single dose of GEM103 will be assessed based on the occurrence of dose-limiting toxicities (DLTs). Each subject will be followed for safety, pharmacokinetic (PK), clinical, and biomarker evaluations. Three escalating dose cohorts are planned.

This is a Phase 1, multicenter, open-label, single-dose, dose-escalation study in subjects with GA secondary to dry AMD to investigate the safety, tolerability, pharmacodynamics (PD), and immunogenicity of IVT injections of GEM103 to a single eye.

The study is designed to identify the MTD for IVT administration of GEM103. Safety and tolerability of a single dose of GEM103 will be assessed based on the occurrence of DLTs. Three escalating dose cohorts are planned.

Subjects will undergo clinical and ophthalmic assessments for inclusion eligibility into the study. Enrolled subjects will receive GEM103 and be followed for safety, PK, clinical, and biomarker evaluations.

Eligibility Criteria:
Inclusion Criteria:

1. At least 50 years old at the time of signed informed consent
2. Able to cooperate sufficiently for adequate ophthalmic visual function testing and anatomic assessment and provide informed consent prior to initiation of any study procedure
3. Best corrected visual acuity (BCVA) in study eye between 5-45 letters
4. Confirmed diagnosis of central GA in the study eye and eligible total GA lesion size

Exclusion Criteria:

1. Presence of the following ocular conditions - in the study eye:

   * Exudative AMD or choroidal neovascularization (CNV)
   * Any ocular disease or condition that could impact the subject's ability to participate in the study or be a contraindication to IVT injection
   * Any intraocular surgery (with the exception of intraocular lens replacement surgery more than 3 months prior to consent)
2. Presence of any of the following ocular conditions - in either eye:

   * History of herpetic infection
   * Ongoing treatment with antiangiogenic therapies in the fellow eye or completed treatment in the study eye
3. Any prior or ongoing medical condition (e.g. ocular other than dry AMD, systemic, psychiatric) or clinically significant screening laboratory value that may present a safety risk, interfere with study compliance, interfere with consistent study follow-up, or confound data interpretation throughout the longitudinal follow-up period
4. Female subjects must not be pregnant or lactating
5. Current use of medications known to be toxic to the lens, retina, or optic nerve
Radiofrequency and Myofascial Pain Syndrome in Postpartum Pelvic Pain

About 30% of women experience pain in the perineum and pelvic region one year after the vaginal labor, rising up to 50% when it is triggered during vaginal penetration, called this pain as dyspareunia. An early physiotherapy treatment could be the solution to the pain relief of these women. Thus, the objectives of the present randomised clinical trail are (i) to determine the effectiveness of a physiotherapy treatment based on education therapeutic, the treatment of myofascial pain syndrome (MPS) of the pelvic floor muscles (PFM), and PFM specific training with or without radiofrequency in reducing pain and improving sexual function; and, (ii) to know the facilitating factors and barriers in adherence and perceived self-efficacy towards physiotherapy treatment of women with pelviperineal pain in the postpartum.

Methodology: randomized clinical trial with examinator blinding and two parallel groups, followed by a qualitative study. Thirty eight women per group will be needed with postpartum pelviperineal pain between 8 weeks after labour, with intensity ≥ 4 cm on the visual analogue scale. The assignment will be random to an Experimental 1 group based on therapeutic education, plus conservative and invasive treatment of MPS and specific PFM exercise versus an Experimental 2 group consisted in the same treatment plus non-ablative radiofrequency treatment. In both cases, 12 individual supervised sessions will be held by a physiotherapist specialized in women's health, with evaluations pre- and post-intervention, at 3 and 6 months. The outcome variables will be the intensity of the pain, the presence of MPS at PFM, the PFM contraction quality, sexual function and specific quality of life. The qualitative study will be carried out in the assessment 6 months post-intervention, through interviews semi-structured and focus groups. The interviews will be guided with previous questions established, recorded, transcribed and thematically analyzed by a panel of experts.


Eligibility Criteria:
Inclusion Criteria:

* Primiparous women
* Eutocic vaginal birth
* Postpartum pelviperineal pain 8 weeks after birth
* Intensity ≥ 4 cm in the VAS
* Freely signed the Informed consent

Exclusion Criteria:

* Multiparous women
* Instrumental delivery
* Cesarean delivery
* Avulsion of the levator ani muscle
* Diagnosis of coccygodynia and/or coccygeal pain
* Sphincter anal injury during vaginal birth
* History of pelvic fractures and/or neoplasms
* Pregnant women
* Neurological diseases
* Vaginal infection or active urinary tract, or with any
* Uterine device with metallic components
* Women with cognitive, auditory and/or visual limitations to understand information, respond to questionnaires, consent and/or participate in the study.
Using Real-world Evidence to Analyze the Clinical Effects and Adverse Events of Butylphthalide in Stroke Patients

This is a retrospective, multi-center, real-world study. The researchers plan to include 10,000 cases of ischemic stroke patients using butylphthalide and 10,000 cases of ischemic stroke patients using Edaravone. The main purpose is to analyze the effectiveness and safety of butylphthalide and establish the drug risk assessment management plan.

Ischemic stroke is a type of syndrome in which blood supply to the brain is impaired due to various reasons, leading to local brain tissue ischemia, hypoxic necrosis, and corresponding neurological deficits. It has a high incidence, high morbidity and disability. Features of high recurrence rate.

Butylphthalide can improve the damage of central nervous system in patients with acute ischemic stroke, and can promote the improvement of patients with neurological deficits. Regarding butylphthalide in the treatment of ischemic stroke, there is still a lack of big data research based on the efficacy and safety of the real world.

Therefore, it is planned to include 10,000 patients who used butylphthalide or Edaravone in five hospitals from 2019 to 2021, and record the basic information of the patients, medication status and related test results. The data was cleaned, sorted and analyzed to evaluate the effectiveness and safety of butylphthalide in the treatment of ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

* From January 2019 to August 2021, clinicians diagnosed patients with ischemic stroke requiring hospitalization.

Exclusion Criteria:

* Patients who are unable to obtain information such as medical advice, laboratory test results, etc.
Dental Support and the Second Stage of Labor Among Multiparous Women

To assess if the use of the dental support device( DSD) Laboraide™ shortens the second stage of labor and decreased the rate of obstetrical interventions, and if it's use alleviate pain.

Several studies have demonstrated that a dental support device (DSD) may increase the isometric strength of different muscle groups (1-7). A preliminary pilot study of 32 women in 2009 showed that DSD may shorten the second stage of labor among nulliparous women (8) by increasing the expulsive efforts of the parturient. The study hypothesis was that DSD may decrease the length of the second stage of labor and decrease the need for obstetrical interventions such as cesarean delivery or operative vaginal delivery.

The Laboraide™ is a DSD developed specifically for use during labor. It is an inert device located between the jaws and does not interfere with speaking, breathing or any other oral activity during labor. It is a single use device, and is not transferred between women. We hypothesize that using this device can shorten the second stage of labor and decrease obstetrical intervention rate. We will also investigate it's efficiency in pain management.

Eligibility Criteria:
Inclusion Criteria:

1. Singleton gestation
2. Multiparous women
3. Term gestation (\>37+0/7 weeks)
4. Signed written consent to participate in the study
5. Maternal age 18-45 years
6. Normal vital signs
7. Noraml cardiotocography and biophysical profile at admission

Exclusion Criteria:

1. Multiple gestation
2. Nulliparous women
3. preterm gestation (\<37+0/7 weeks)
4. Refusal to participate
5. Maternal age \<18 or \> 45 years
6. Normal vital signs
7. Abnormal cardiotocography and biophysical profile at admission
Mobile App for Mood in Pregnancy (Ginger iO)

The Mobile Mood Tracking App study is a small randomized trial of acceptability and usability of a mobile phone mood tracking application (mobile app) among women with depressed mood in pregnancy. The study will be assessing the perceived value and usability of this tool in pregnancy over eight weeks to test whether women using this app are more likely to receive assessments and treatments of depressed mood than women not using it.


Eligibility Criteria:
Inclusion Criteria:

* Positive screening for elevated depression symptomatology (PHQ-9 score must be greater than or equal to 5.)

Exclusion Criteria:

* Women with pregnancies of less than 33 weeks gestation.
Comparison of Clinical Outcomes in Ziemer Femtosecond Versus Conventional Phacoemulsification Surgery

This study is aimed to compare the clinical outcomes in Ziemer LDV Z8 femtosecond laser-assisted cataract surgery versus conventional phacoemulsification cataract surgery

This study is aimed to compare the clinical outcomes in Ziemer LDV Z8 femtosecond laser-assisted cataract surgery versus conventional phacoemulsification cataract surgery. This study will be a non-inferiority study and ninety-five patients will be recruited.

Eligibility Criteria:
Inclusion Criteria:

1. A cataract will be defined as clouding of the lens that interferes with normal vision.
2. Not relevant, as study not on cancer patients.
3. Only patients older than 50 years will be included, as cataracts develops with increasing age. No gender criteria are applied.
4. Only individuals with the mental capacity to provide informed consent with be included.

More specifically, all the following inclusion criteria must be met:

1. Patients have medically dilated pupil size of at least 4.0mm.
2. Patients are willing and able to sign a written Informed Consent Form prior to any study-specific procedures.
3. Patients are willing and able to return for scheduled follow-up examinations for 12 months after the cataract surgery.

Exclusion Criteria:

1. Patients with prior history of pseudoexfoliation syndrome.
2. Patients with a prior history of glaucoma filtration surgery.
3. Patients with optic atrophy.
4. Patients with ocular pathology or disease (including pupil pathology such as fixated pupils) that might confound the outcome or increase the risk of adverse event..
5. Patients with a prior history of vitrectomy.
6. Patients with a prior history of cataract or refractive lens surgery
7. Patients with central corneal scarring.
8. Patients with residual, recurrent, active or uncontrolled eyelid disease.
9. Patients with significant corneal asymmetry or irregular topography.
10. Patients with anterior segment pathology.
11. Patients with any corneal abnormality
12. Patients with any progressive retinal disease or subjects with a history or evidence of retinal vascular occlusion and/or hypercoagulability, because of the risks associated with high pressures during suction application.
13. Patients with amblyopia or strabismus or those who are at risk for developing strabismus postoperatively as determined by corneal light reflex and cover-uncover testing.
14. Patients who are pregnant, lactating, of child-bearing potential and not practising a medically approved method of birth control, or planning to become pregnant during the course of the trial, and patients with other conditions associated with fluctuation of hormones that could lead to refractive changes.
A Digital Game on Promoting Family Well-being

Advances in information communication technologies (ICT) allow for ICT-assisted health promotion to become more common. Integrating ICT in health promotion has been suggested to offer many advantages compared to traditional approaches to promote family well-being. Research has also shown the positive effects of game-based approaches in enhancing health promotion interventions, especially with children. We will develop and assess a digital family game with theme-based mini-games to enhance family communication and well-being.

With growing emphasis on the development and maintenance of healthy lifestyles, the family role has increasing importance. A family-based health promotion strategy can be instrumental in helping disseminate and reinforce knowledge and behaviours on family well-being and better equip families to protect themselves and promote family well-being amidst the pandemic.

This study aims to use a game-based approach to enhance knowledge and behaviours on family well-being. We will conduct quantitative and qualitative evaluation. The findings would provide preliminary evidence of the feasibility and effectiveness of such an approach in a family-based context. It would also guide the direction for future health education and awareness trials and related projects and campaigns for health promotion efforts and to help improve family well-being in the Hong Kong community and elsewhere.

Eligibility Criteria:
Inclusion Criteria:

* Chinese-speaking;
* Individuals aged 18 years and above;
* Able to understand and play the game.

Exclusion Criteria:

* Individuals who cannot meet the inclusion criteria.
Clinical Research Evaluating Smoking Cessation With E-Cigarettes and Nicotine Therapy

This project will investigate the effects of alternative nicotine products on smoking, weight gain, and related outcomes.

The purpose of this study is to provide preliminary information on the effect of electronic cigarettes (EC) and nicotine replacement therapy (NRT) among SWO. This study will randomize up to 60 individuals who smoke cigarettes with comorbid obesity (SWO) to receive (1) electronic cigarettes (EC), (2) nicotine replacement therapy (NRT), or 3) a no-product control (CON) condition for 8 weeks. Assessments will occur at baseline, and 1, 2, and 3-months follow-up, aiming: 1) To compare EC, NRT, and CON on smoking, exhaled carbon monoxide, and number of quit attempts; 2) To compare EC and NRT on acceptability and adherence; 3) To compare EC, NRT, and CON effects on weight, central adiposity, glucose regulation, inflammation, cotinine, and blood pressure at follow-up.

Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) ≥ 30 kg/m2 (i.e., obese)
* smoked ≥ 5 cigarettes/day during the past year
* 21 or older (due to minimum legal age EC restrictions)
* exhaled breath carbon monoxide (CO) level \> 6 ppm at Baseline (BL) (to confirm self-reported smoking)
* willing to use EC or NRT for 8 weeks
* access to a Bluetooth-enabled smartphone/tablet (to permit remote measurement of CO and other outcome variables)

Exclusion Criteria:

* received smoking cessation treatment of any kind in the past 30 days (actively quitting smoking),
* currently using EC or NRT more than 2 days/week (this may affect responses to study-supplied products)
* hospitalized for mental illness in past 30 days
* heart-related event (e.g., heart attack, severe angina) in past 30 days
* residing with another person currently enrolled in the study
* pregnant, nursing, or planning to become pregnant in the next 6 months
* medical contraindication for study or product use (e.g., allergy to adhesives)
* taken prescription weight loss medication in the last 30 days
A Study of Xenical (Orlistat) in Overweight and Obese Adolescents

This 2 arm study will assess the effect of Xenical on body mass index (BMI)in obese or overweight adolescents. Patients will be randomised into one of 2 groups; both groups will undergo a regimen of mildly hypocaloric diet and physical exercise, but one group will also receive Xenical 120mg po tid. The anticipated time on study treatment is 1 year, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adolescent patients, 12-14 years of age
* overweight or obese

Exclusion Criteria:

* age \<12 or \>14 years
* BMI in normal range
Drug Use Prevention Among Girls Through a Mother-Daughter Intervention

This study will develop and test drug use prevention strategies for low-income, minority girls. Gender-specific substance use rates, risk and protective factors, and health outcomes highlight the need for interventions aimed at girls. Girls and boys share a number of risk factors, yet some factors are more salient for one gender. Girls and boys may also be affected differently by the same risk factors. Intervention planned for this study emphasizes risk and protective factors that impact girls. Our intervention will build mother-daughter communication and closeness; enhance girls' self-efficacy and body esteem; nurture girls' conflict management, problem-solving, stress reduction, and refusal skills; correct perceived norms; build social supports; and establish patterns of parental monitoring and supervision. We hypothesise that girls who receive GSI will have lower 3-year follow-up rates of substance use than girls who receive no intervention.

The study will occur in three phases. In a 12-month preparation phase, we will refine and complete intervention and measurement protocols, recruit subjects and randomly assign girls and mothers to study arms, and pretest girls and mothers. A 12-month implementation phase will initiate field operations of the clinical trial, including intervention delivery, process data collection, and posttests. Follow-up in the last 36 months will involve longitudinal measurements of girls and mothers, booster session development and delivery, and data analyses.

The study has two primary and seven secondary aims.

Primary Aims:

* 1. Develop a family-based girl-specific intervention (GSI) to prevent substance use.
* 2. Test the efficacy of GSI.

Secondary Aims:

* 3. Test GSI to improve mediating factors of girls' mother-daughter affective quality, coping, refusal skills, mood management, conflict resolution, problem solving, self-efficacy, body esteem, normative beliefs, social supports, and mother-daughter communication.
* 4. Examine the effects of mediating factors on girls' substance use behavior.
* 5. Test GSI to improve mothers' use of family rituals, rules against substance use, child management, mother-daughter affective quality, and communication with their daughters.
* 6. Examine the effects of mother' outcomes on their daughters' substance use behavior.
* 7. Test the effects of dose on participants' outcomes.
* 8. Determine if GSI has differential outcomes related to ethnic-racial group profile.

  9. Quantify the costs of intervention development and delivery.

Eligibility Criteria:
Inclusion Criteria:

* girls ages 11 to 13 years old at pretest and their mothers who have access to a private computer

Exclusion Criteria:

-