cyrilzakka/clinical-trials huggingface dataset:
Safety and Effectiveness of an Hydrophilic Acrylic Intraocular Lens

Evaluation of the clinical safety and effectiveness of hydrophilic acrylic intraocular lens

To show safety and the effectiveness in regard to the monocular corrected distance visual acuity (CDVA) at 12-24 month postoperative.

Eligibility Criteria:
Inclusion Criteria:

* Patients of any gender, aged 18 years or older at the time of the surgery
* Patients who had an uncomplicated (no intra-operative complication) aged-related cataract surgery
* Currently implanted with the study device into the capsular bag in at least one eye
* One-year post surgery follow-up (365 days -14 days/+365 days) for the study eye at the time of the postoperative visit
* Patient is willing and capable of providing informed consent
* Patient is willing and capable of complying with visits and procedures as defined by this protocol

Exclusion Criteria:

* Preoperative corrected distance visual acuity (CDVA) better than 0.3 LogMAR (0.5 decimal) or CDVA not available preoperatively
* Preoperative documented endothelial cell count of less than 2000/mm2 (if available)
* Any preoperative documented ocular disorder that could potentially cause a clinically significant future visual acuity loss
* Any preoperative documented clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.)
* Any preoperative documented clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
* Any preoperative documented clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)
* Any preoperative documented history of clinically significant retinal pathologies or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) that could alter or limit final postoperative visual prognosis
* Any preoperative acute infection (acute ocular disease, external/internal infection, systemic infection)
* Any previous preoperative intraocular and corneal surgery
* Preoperative documented uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment
* Preoperative documented or current systemic or ocular pharmacotherapy that effects patients' vision
* Any other preoperative documented or current pathology or condition that could be a risk for the patient according to the investigator opinion
* Women during pregnancy and/or lactation at time of enrollment into the study
* Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial
* Patients whose freedom is impaired by administrative or legal order
* Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, that do not affect patients' vision
Misoprostol+Oxytocin vs. Carbetocin in CS

This prospective randomized double-blind clinical trial will be conducted at Ain-Shams University Maternity Hospital, Cairo, Egypt. Patients eligible for elective lower segment cesarean section will be randomized to 2 groups. Group 1: will receive 400 ug misoprostol following + 10 IU oxytocin intravenous slowly after cord clamping. Group 2: will receive 100 ug carbetocin intravenous after cord clamping.


Eligibility Criteria:
Inclusion Criteria:

* Women with singleton pregnancy Women scheduled for elective CS full term (gestational age ≥37 weeks).

Exclusion Criteria:

* hypersensitivity to oxytocin, carbetocin or prostaglandins
* contraindication to prostaglandins (e.g. glaucoma)
* history of significant heart disease
* severe asthma
* epilepsy
* history or evidence of liver
* renal or vascular disease
* history of coagulopathy
* thrombocytopenia or anticoagulant therapy
* women with HELLP syndrome
* eclampsia
* women presenting by placental abruption
* contraindication to spinal anesthesia as carbetocin is licensed for use with regional anesthesia only.
Mindfulness-Based Childbirth and Parenting Education on Pregnant Women

The purpose of this study is to explore the differences between stress, depression, childbirth self-efficacy, mindfulness and postnatal maternal outcomes in pregnant women with Mindfulness-Based Childbirth and Parenting education program.

Being a mother is a huge change for women, and she will undergo a high degree of change and a strong threat in this transformation process. The purpose of this study is to explore the efficacy of a Mindfulness-Based Childbirth and Parenting(MBCP) Education Program on prenatal stress, depression, mindfulness, childbirth self-efficacy, and postnatal maternal outcomes.

Randomized Controlled Trial comparing two education programs with health and singleton pregnant women is run by the Random Allocation Software (Saghaei, 2004). Use the G-Power 3.1.9 windows: repeated measures and between factors among two groups to calculate the number of samples, and setting the power = .8, α = .05, effect size = .25. The estimated number of samples may be lost 20%, total 104 samples ( 52 samples in each group).

The protocol for the study used MBCP education, this program helps participants practice in the present moment, so that they may develop more confidence and well-being during pregnancy. The MBCP course is held for 3 hrs once a week for 8 weeks. They also had the home practice of 30 minutes a day with a DVD for the experimental group. The control group attending a hospital-based antenatal education program for 2 hrs once a month for 2 months from hospital staff nurses in all aspects of pregnancy, childbirth and postpartum. This study uses a standard verbal script to the eligible participants who were volunteers of pregnant women in the waiting room of metropolitan hospital in Taiwan.

Eligibility Criteria:
Inclusion Criteria:

* Subjects were pregnant from 13th to 28th weeks gestation with a singleton pregnancy
* Subjects were at the age over 20
* Could speak and read Chinese fluently
* Willing and be able to attend the education program
* Determined to have a vaginal birth

Exclusion Criteria:

* Taking medication for diagnosing mental illness
* With complicated or high-risk pregnancies
Improving Dynamic Balance and Gait Adaptability Using Treadmill Training

Balance and gait problems in subjects with neurological disease lead to reduced mobility, loss of independence and frequent falls. Treadmill training is a widely used form of treatment and it has been used in subjects with neurological disease to ameliorate walking and balance deficits. The Virtual Reality Treadmill as a therapeutic tool has been recently introduced to practice gait adaptability elicited by aligning foot placement relative to the projected visual context.

Forty-eight subjects with neurological disease will receive treadmill training treatment randomly divided in Traditional Treadmill training and Virtual Reality Treadmill training.

The aim of this randomized controlled study is to assess whether Treadmill training with Virtual Reality is better than Traditional Treadmill training in improving dynamic balance and cognitive aspects in subjects with neurological diseases.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Multiple Sclerosis (no relapse within the previous three months;), Parkinsons Disease (Hoenhn and Yahr Scale ≤4), Stroke (Time from onset \>2 months)
* Able to walk 20 meters with or without assistive device
* Cognitive impairment (MMSE score ≥ 21)

Exclusion Criteria:

* Unable to understand the aim of the study and unable to sign the informed consent
* Steroidal drugs therapy for subjects with Multiple Sclerosis
* Subjects with Psychiatric disorders
* Subjects with Visual impairments
* Subjects with cardiovascular disease
Fitness and Daily Function in Adults

The purpose of this study is to examine the impact of aerobic fitness on the ability of able and disabled older adults to perform daily functional activities. Subjects are tested in their oxygen use patterns as they perform a series of functional tasks (such as walking on stairs) and following a 24-week training program focused on improving the ability to perform daily tasks likely requiring aerobic fitness (such as walking on stairs).


Eligibility Criteria:
Both healthy and self-reported mobility-impaired older adults
Peripheral Arterial Insufficiency Associated With HIV/AIDS

The purpose of this study is to determine the risk factors associated with the occurrence of arterial insufficiency in patients with HIV / AIDS, and to identify the prevalence of this disease. The estimated prevalence is 10%, similar to that reported in the general population.

A case study nested in a cohort of patients with HIV / AIDS at Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico, with a cohort of 1500 patients , a sample size of 206 individuals was calculated. Data collection was performed in a prospective cross shape.

During the interview, written informed consent for inclusion in the study, along with a standard query of vascular surgery in which the patient's history as well as cardiovascular risk factors. Also, a vascular physical examination including palpation of pulses in upper and lower extremities (brachial, radial, ulnar, femoral, popliteal, posterior tibial and dorsalis pedis), femoral murmurs search and determining ankle / brachial indexes with a standardized method.

In determining the ABI was counted with a Doppler ultrasound 8 mHz, transducer gel and a sleeve for manual measurement of blood pressure, 20% longer than the largest diameter of the arm circumference.

If the patient is diagnosed with, symptomatic or asymptomatic arterial insufficiency, ABI measurements were performed at rest and effort, plus pressure index finger-arm or plethysmography. Patients with altered rates were followed in vascular surgery care.

The data were recorded in a single database unique protected by password. The results were analyzed using the statistical program STATA v 9.0.

Eligibility Criteria:
Inclusion Criteria:

* Patients with HIV / AIDS are included in active consultation of Infectious Diseases INCMNSZ and sign informed consent.

Exclusion Criteria:

* Patients who do not wish to participate in the study and those who did not complete their interview and vascular physical examination.
Third-generation EGFR-TKI Treatment in Metastatic EGFR-mutant NSCLC

The goal of this observational study is to explore the feasibility of stereotactic radiotherapy (SRT) as consolidation therapy for patients with advanced non-small-cell lung cancer who were treated with third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). The investigators plan to explore the time to achieve the best response after EGFR-TKI treatment, the characteristics of the distribution of lesions when the best response is achieved, the feasibility of SRT when the best response is achieved, and the phenotype of disease progression after EGFR-TKI resistance.

In summary, this study will provide critical information for exploring the feasibility and optimal design of SRT as consolidation therapy for advanced NSCLC patients treated with third-generation EGFR-TKI, which will further promote the optimization of comprehensive treatment for EGFR-mutant advanced NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed non-small cell lung cancer;
* clinical stage IV (AJCC, 8th edition, 2017);
* EGFR sensitizing mutations (L858R or 19del);
* age≥18 years old;
* KPS score≥70;
* complete systemic imaging (including brain MRI) before third-generation EGFR-TKI treatment;
* received standard third-generation EGFR-TKI therapy (monotherapy or combined with brain radiotherapy);
* willing to cooperate with the follow-up after third-generation EGFR-TKI treatment;
* informed consent of the patient.

Exclusion Criteria:

* Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years);
* Pregnant or lactating women who, as judged by the investigator, were not candidates for brain MRI;
* Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance.;
* patients without EGFR sensitive mutations or with unknown EGFR mutation status.

Withdrawal criteria

* The investigators considered that the patients had poor adherence to the study protocol.
* The patient withdrew informed consent and asked to withdraw.
* There was any safety reason (adverse event) considered by the investigator;
* Due to other underlying diseases, side effects, economic factors, and other reasons, patients did not receive regular doses of third-generation EGFR-TKI (continuous withdrawal time more than 1 week, cumulative withdrawal time more than 2 weeks, etc.).
* The patient was not followed up according to the protocol.
* Other circumstances in which withdrawal from the study was deemed necessary by the investigator.
A Post Breastfeeding Follow-Up Study

The purpose of this clinical study which is to evaluate the benefits of lactation support intervention, in conjunction with maternal nutritional supplementation during the last trimester to 12 weeks postpartum in comparison to pre- and postnatal care on 1) breast feeding practices (primary objective), and 2) cognitive development in children within 28 months 16 days - 32 months 30 days (secondary objective).

This is an observational study involving mothers and their child at 30 months old as a follow up to the breastfeeding intervention study that they have participated in and completed during the period from the last trimester to 12 weeks postpartum.

The assessors will be blinded to subject's treatment group assignment from the intervention phase.

There are no products given to any subject.

The primary variable is duration of any breastfeeding from birth.

Eligibility Criteria:
Inclusion Criteria:

* Mother and child pair was enrolled in and completed the breastfeeding intervention (AL08) study.
* Age of child is within the allowable window (28 months 16 days - 32 months 30 days).
* Subject's parent/Legally Acceptable Representative (LAR) is willing and able to follow study procedures.
* Subject's parent/LAR has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) or other applicable privacy regulation authorization prior to any participation in the study.

Exclusion Criteria:

* Child has a diagnosis of developmental disorders e.g. cerebral palsy that require medical intervention prior to enrollment in this study.
Treatment of Cerebral Arteriovenous Malformations With SQUID Liquid Embolic Agent (CHOICE)

The objective of this study is to further establish that SQUID, an alternative liquid embolic agent with specific properties, is a safe and effective alternative in bAVM endovascular treatment strategy available to date. Therefore, the performance of SQUID will be documented and its safety of use will be confirmed in current practice.


Eligibility Criteria:
Inclusion Criteria:

* Patient planned for one or multiple embolization sessions using SQUID to achieve occlusion of a previously untreated bAVM.\*

  \*Patients with a direct fistula or saccular/flow-related aneurysm previously treated with NBCA and/or coils may be included.
* Patient in whom the use of SQUID had been decided for an embolization alone or in association to neurosurgery or radiotherapy.
* Patient ≥18 years old.
* Patient or authorized representative dully informed and having no objection to the clinical data collection and medical file access. An informed consent form must be signed and dated whenever required by local legislation

Exclusion Criteria:

* Patient with bAVM not eligible for endovascular treatment.
* Patient with bAVM previously treated by embolization with other devices (Liquid embolic agent, NBCA, particles, and coils).\*

  \*Patients with a direct fistula or saccular / flow-related aneurysm previously treated with NBCA and/or coils may be included.
* Patient with bAVM previously treated with surgery or radiotherapy.
* Patient intended to undergo surgery and embolization during the same procedure at first embolization
* Patient with multiple bAVM or bAVM associated with dural arteriovenous Fistula\*.

  \*Patients with a direct fistula or saccular / flow-related aneurysm previously treated with NBCA and/or coils may be included.
* Patient presenting contra-indication to the use of SQUID according to the Instructions For Use.
* Intention to treat with any non-adhesive embolic liquid other than SQUID, or planned treatment with another non-adhesive embolic liquid over the course of the endovascular treatment phase.
* Patient planned for a total endovascular treatment phase duration exceeding 2 years.
* Patient participating in another clinical study evaluating another medical device, another procedure or a medication.
* Any condition or any situation that would prohibit the patient from coming to the investigational center for the follow-up as recommended by the study protocol between 3 and 6 months, or prohibit carrying out the telephone mRS assessments at 1 month after each embolization session and at 12 months after the end of the endovascular treatment phase.
Severity of Fecal Incontinence and Manometric Values Using the Anopress® Device in Women

The purpose of this study is to stablish a correlation between fecal incontinence severity scales (Wexner \& St. Mark's) and manometric values obtained using the Anopress® portable manometry and values obtained using endoanal ultrasound in women with fecal incontinence.

The Anopress® portable anal manometry will be used to measure the pressures of the anal canal in different phases: rest, squeeze, strain and endurance.

All female patients referred with the diagnosis of fecal incontinence giving written informed consent will undergo a endoanal portable manometry at our outpatients clinics. They will be asked to fill out the severity questionaries (Sant Mark's and Wexner). All data will be collected for analysis.

An endoanal ultrasound will be performed in all patients to assess the sphincter integrity.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the clinical diagnosis of fecal incontinence
* Age ≥ 18 years.
* Informed consent signed by the patient and the researcher.

Exclusion Criteria:

* Patients with psychiatric illnesses, addictions or any disorder that prevents understanding of the study.
* Inability to read or understand the questionnaires.
* Inability to read or understand any of the informed consent languages (Catalan, Spanish).
* Any patient who, due to his medical characteristics, presents a high individual risk when being included and completing the study.
Observational Study to Investigate the Occurrence of Bleeding in Postmenopausal Women Treated With Estradiol/NETA for 12 Months

This study is conducted in Europe. The primary aim of this observational study is to investigate the occurrence of bleeding in women taking 0.5 mg estradiol and 0.1 mg norethisterone acetate (NETA) for 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent, permitting the data to be processed within the scope of the study, is obtained from the patient before any study-related activities
* Postmenopausal amenorrhoeic women
* Treatment with previously combined HRT discontinued at least 3 months prior to start of 0.5 mg estradiol and 0.1 mg norethisterone acetate treatment
FYS Study: Epidemiological, Multicentre, Cross-sectional Study in a Clinical Practice Environment, About the Relationship Between Functioning Status and the Quality of Sleep Perceived by Schizophrenic Outpatients in Spain

The purpose of this study is to establish the relationship between performance of patients with schizophrenia and relationship with perceived quality of sleep. The secondary objectives are: to establish the prevalence of schizophrenic patients reporting sleep disturbances; to assess the potential epidemiological risk factors associated with the perceived impairment of quality of sleep; to establish the relationship between the clinical condition and the quality of sleep perceived; to assess the performance level of patients.

This is a multicenter, cross-sectional, epidemiological study in the daily clinical practice on the relationship between personal and social functionality and quality of sleep perceived in outpatients with schizophrenia. It is proposed to perform a simple screening for detecting schizophrenic patients reporting sleep disturbances. These patients will be assessed in a single visit and will be administered a number of quality of life and functional assessment scales. N/A

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed of schizophrenia
* reporting sleep disturbances at the time of the visit or patient not reporting sleep disturbances at the time of the visit
* who are on stable antipsychotic therapy for at least 6 months prior to inclusion in the study
* (or guardian/ legal representative) consenting to participate in the study by signing the written informed consent.

Exclusion Criteria:

* Patient who, in the investigator's opinion, fails to keep an adequate cognitive ability to continue the study and complete the questionnaires
* who has any type of severe sleep disturbances related to disorders of the patient other than schizophrenia (e.g., nightmares, nocturnal fears, restless leg syndrome)
* or included in another clinical study or trial that can interfere with the normal control of the disease.
A School-Based Osteoporosis Prevention Program for Adolescent Girls

The Incorporating More Physical Activity and Calcium in Teens (IMPACT) study was a behaviorally-based middle school nutrition and physical activity program for the prevention of osteoporosis. The goal of IMPACT was to increase calcium intake and physical activity to help build bone mass in girls.

Peak bone mass is achieved during the first twenty years of life, and dietary and activity patterns that contribute to the formation of peak bone mass are developed during childhood. The IMPACT intervention was designed to increase bone density and ultimately prevent osteoporosis during adulthood. IMPACT included physical education, food service, and classroom environmental and behavioral components and was delivered by physical education (PE) specialists, food service personnel, and classroom teachers.

A group of 718 sixth grade girls (mean age 11.1) from twelve middle schools in central Texas participated in the study. The group was 72% non-Hispanic white, 12% Hispanic, 5% African American, and 11% other ethnicity. After baseline measurements were completed in the fall of 2000, the twelve middle schools were pair-matched based on school characteristics (ethnicity, % economically disadvantaged, % girls in athletics) to a control (usual health education program) or the IMPACT program. The intervention was implemented for 18 months and consisted of three major components: a PE component, which emphasized daily weight-bearing activities (WBA); a health lessons component consisting of sixteen behaviorally-based lessons which emphasized WBA, calcium-rich foods, and osteoporosis prevention; and a food service component.

Outcome measures included physical properties of the students' heel bones, calcium consumption, physical activity, and psychosocial factors believed to be precursors to these behaviors. Changes at the school environmental level, such as the number of calcium rich foods offered in the cafeteria and the number of opportunities offered for weight-bearing and aerobic activity, were also assessed.

Eligibility Criteria:
Inclusion Criteria:

* Girls enrolled in 6th grade of selected schools
* Student assent
* Parental consent
* No fractures or medications that compromise bone health or strength
* Enrolled in 2 semesters of physical education