cyrilzakka/clinical-trials huggingface dataset:
Spectacle Independence and Overall Satisfaction With AcrySof® Panoptix® Toric Intraocular Lens

The study was designed to assess the spectacle independence and satisfaction of patients receiving the AcrySof® Panoptix® Toric intraocular lens (IOL) after uneventful cataract surgery.

This study is a single-arm unmasked clinical evaluation study of spectacle independence after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a spectacle independence and a quality of life questionnaire, as well as measurement of bilateral visual acuity and manifest refraction.

Eligibility Criteria:
Inclusion Criteria

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

* Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using a multifocal toric IOL option
* Gender: Males and Females.
* Age: 40 or older.
* Willing and able to provide written informed consent for participation in the study.
* Willing and able to comply with scheduled visits and other study procedures.
* Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)
* Have regular corneal astigmatism with a magnitude that can be treated with a toric IOL in the approved range (T3-T6) for the Panoptix lens.
* Have 20/32 (0.2 logMAR) or better potential acuity in both eyes

Exclusion Criteria If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

* Irregular astigmatism (e.g. keratoconus)
* Corneal pathology (e.g. scar, dystrophy, pterygium, moderate-to-severe dry eye)
* Monocular status (e.g. amblyopia)
* Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, DSAEK, lamellar keratoplasty)
* Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
* Diabetic retinopathy
* Macular pathology (e.g. ARMD, ERM)
* History of retinal detachment
* Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity.
* Participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating).

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Energy Specific Far Infrared Radiation Treatment for Sciatica

A preliminary study to determine the use of far infrared radiation for the treatment of back pain

Sciatica is created by joint misalignment, muscle spasm and inflammation. Generally, sciatica is a combination of lower back pain, pain radiating into the buttock and possibly down the leg.

Far infrared radiation of the sciatic nerve, coupled with the stretching of the spinal cord, is a promising non-invasive method for treating sciatica.

Eligibility Criteria:
Inclusion Criteria:

* Persons with lower back pain

Exclusion Criteria:

* None
Association Between Effectiveness of Mirikizumab and UC Patients with High Neutrophilic Infiltration in Epithelium of the Colonic Mucosa

The goal of this study is to confirm that Mirikizumab therapy may provide clinical, endoscopic, and histopathologic improvements in patients with moderate to severe UC refractory to maintenance therapy when high neutrophilic infiltration in epithelium of the colonic mucosa (Geboes score Grade ≥3.2) on endoscopic biopsy is found.


Eligibility Criteria:
Inclusion Criteria:

* They were endoscopically active ulcerative colitis patients.

Exclusion Criteria:

* the presence of a long-term illness, colorectal cancer, or infectious colitis
A Trial Investigating the Effect of NN5401 in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to evaluate the blood glucose-lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index below or equal to 35.0 kg/m\^2

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Incidence of Flare-ups and Apical Healing After Single-visit or Two-visits Treatment.

Aim to compare Incidence of flare-ups and apical healing after single-visit or two-visits treatment of teeth with necrotic pulp and apical periodontitis after a two-year control period.

110 teeth with a diagnosis of pulp necrosis and apical radiolucency at the apex. Working length was established with EAL and confirmed radiographically. M4 system with Flex-R files were used to complete canal preparation. Level of discomfort were recorded and cases with severe postoperative pain and/or swelling were classified as flare-ups.

110 teeth with a diagnosis of pulp necrosis and apical radiolucency at the apex. Working length was established with EAL and confirmed radiographically. M4 system with Flex-R files were used to complete canal preparation. Level of discomfort were recorded and cases with severe postoperative pain and/or swelling were classified as flare-ups.

Eligibility Criteria:
Inclusion Criteria:

* a) Radiographic evidence of apical periodontitis (minimum size ≥2.0 mm x 2.0 mm) and a diagnosis of pulpal necrosis confirmed by negative response to hot and cold tests and b) Need for retreatment. Thermal pulp testing was performed by the author, and radiographic interpretation was verified by one certified oral surgeon.

Exclusion Criteria:

* patients without inclusion requirements or failure to obtain patient´s authorization. Patients, were excluded if they were younger than 18 years old, pregnant, had a positive history of antibiotic use within the past month, suffered from diabetes, or other systemic diseases. Teeth with periodontal pockets deeper than 4 mm also were excluded of the study.
Improving Ambulatory Community Access After Paralysis

The purpose of this research study is to evaluate the effectiveness of functional electrical stimulation (FES) provided by an implanted pulse generator (IPG) in correcting hip, knee and ankle function to improve walking in people with partial paralysis.

In a surgical procedure electrodes are inserted into muscles of the lower extremities to correct hip, knee and ankle function. The electrode leads are connected to an implanted pulse generator located in the abdomen. After a typical post-operative period of two to five days, the recipient will be discharged home for two to six weeks of moderate activity. Following a 6 week period of laboratory exercise and training, functional use of the neuroprosthesis will begin at home and in the community with follow-up evaluations at 1, 3, 6 and 12 months. Laboratory assessments include walking speed and distance, physiologic cost, muscle strength, measure of spasticity, and gait analysis with and without stimulation. A number of self-reporting instruments are administered to capture individual's participation, quality of life and various aspects of perceived community ambulation.

Eligibility Criteria:
Inclusion Criteria:

* problems walking because of paralysis for more than 6 months
* weak hip flexors and extensors or excessive tone
* weak ankle dorsiflexors (muscles bringing the foot up)
* weak plantar flexors (ankle muscles for push-off)
* foot drop that is causing "dragging" or "catching" toes during walking
* swinging the leg sideways or hiking the hip to clear affected leg during stepping
* endurance to walk at least 10 ft with minimal assistance
* hip extension range to neutral
* hip flexion range greater or equal to 90 degrees
* ankle range to neutral
* sufficient upper extremity function to use a walking aid
* muscles respond to electrical stimulation

Exclusion Criteria:

* cardiac arrythmias
* demand pacemaker
* pregnancy
* Parkinson's disease
* traumatic brain injury
* autoimmune deficiency
* uncontrolled diabetes
* significant edema of the affected limb
* active pressure ulcers or open wounds
* sepsis or an active infection
* severe osteoporosis
* uncontrolled seizures
* moderate depression
A Feasibility Study for Growth Bone Vertically With Titanium Mesh and Allograft in Lower Posterior Jaw

This study will involve placing donor bone into the back of lower jaw then covering with a newly designed titanium mesh. The mesh will then stay in the mouth for 4 months before it will be removed. Implants will be placed in the newly formed bone.

The goal of this study is to test how well using a newly designed titanium mesh and bone particles can grow bone in the back of the lower jaw. The investigators are also checking if the newly formed bone will stay around implants that will have been in use for 12 months.

Inclusion Criteria

* Patients are at least 18 years old
* At least two adjacent back teeth in the lower jaw are missing
* No medical contraindication to dental surgery
* Inadequate vertical ridge height at edentulous region (less than 10mm)

Exclusion Criteria

* Unstable systemic diseases or conditions that would compromise the healing potential
* Patients with osseous metabolic disorders (e.g., osteoporosis, Paget's disease etc.)
* Patients who are pregnant or expect to get pregnant
* Patients with unstable dental disease (e.g. caries and periodontitis) in the surgical sextant

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy patients (ASA I or II)
* Non-smoker or light smokers (\< 10 cigarettes per day)
* Good oral health (FMPS and FMBS \<20%)
* At least two adjacent mandibular posterior teeth are missing
* Inadequate vertical ridge height at edentulous region (less than 10mm)
* Missing teeth for ≥ 3 months

Exclusion Criteria:

* Unstable and complicated systemic diseases or chronic disorders precluding surgical procedures
* Systemic diseases with compromised healing potentials (Uncontrolled Diabetes Mellitus, HIV infections, etc.)
* Bone disorders (Hyperparathyroidism, Osteoporosis, Paget's Disease)
* Pregnant or expecting to become pregnant
* Currently smoking (≥ 10 cigarettes/day)
* Poor oral hygiene (≥20% Modified O'Leary Plaque Index)
* Severe grinding, clenching, TMJ disorder
* Untreated dental disease (periodontitis, caries, abscesses) in the research quadrant
* Teeth exhibiting periapical pathology or purulence (symptomatic) in the research quadrant
Application of One-handed Lithotripsy in Percutaneous Nephrolithotomy

Percutaneous nephrolithotomy(PCNL) is a surgical method for upper urinary calculi.Traditional percutaneous nephrolithotomy usually requires the lithotripsy with the left hand holding the nephroscope and the right hand adjusting the laser fiber,which requires a lot of practice to master this technique.The goal of this study is to explore the safety and effectiveness of the PCNL with one-handed lithotripsy technique

This is a key clinical research project of the University of South China(NO.USCKF201902K01).The goal of this study is to compare the safety,effectiveness and feasibility between the percutaneous nephrolithotomy with one-handed technique and the traditional percutaneous nephrolithotomy in the treatment of upper urinary calculi. It is a prospective, randomized controlled single center study that is conducted for 2 years anticipatively. The clinic physician is responsible for patient recruitment and allocation.For random allocation,participants are randomly grouped by coin toss method.Participants with front side are assigned to experimental group,where they undergo PCNL with one-handed lithotripsy.Participants with reverse side are assigned to control group and undergo traditional PCNL.The doctors managing the operations accept participants and execute the surgical treatments.All participants sign clinical-trial informed consent and surgical informed consent during the preoperative conversation.Follow-up observation is conducted for 1 month after surgery. After completion of the study, we collect relevant clinical data from the participants. The primary and secondary outcomes are analyzed and compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Participants who met the the applications of PCNL surgery in the 2019 Chinese Guidelines for the Diagnosis and Treatment of Urological Disease.
* Participants who agree to undergo one-hand lithotripsy.

Exclusion Criteria:

* Obvious surgical contraindications, such as severe heart and lung insufficiency, abnormal coagulatory function.
* Confirmation by computerized tomography (CT) images and blood biochemical indicators of infectious stones or complex staghorn stones
Impact of Family-Centered Care for Intimate Partner Violence (IPV)

The purpose of the study will be to determine how participation in Family-Centered Care (FCC) compared to Child-centered care (CCC) will affect caregiver engagement in IPV-based community services, caregiver perceptions of empowerment and survivor-defined practice, and clinical outcomes for children exposed to IPV.

The study population includes victims of intimate partner violence whose children \< 3-years old have been referred to Child Protective Services due to exposure to IPV and who have agreed to a medical evaluation for the child(ren) in the child advocacy center or the SCAN clinic and don't already have a connection to an IPV advocate. The study population will include adults who are primarily English or Spanish Language preferring. For professionals, the target audience will be local CPS investigators in the New Haven and Hartford CPS office, IPV advocates at the New Haven Umbrella Center for Intimate Partner Violence Services and The Hartford Interval House and child abuse pediatricians at Yale University School of Medicine and at the Connecticut Childrens Medical Center.

Eligibility Criteria:
Inclusion Criteria:

* Have a child \< 3-years-old who been reported to Child Protectives Services for IPV exposure
* Parent \> 18 years old who has agreed to a medical evaluation for the child at the child advocacy center
* Does not already have a connection to an IPV advocate
* Able to speak English or Spanish fluently
* Not a ward of department of children and families

Exclusion Criteria:

* Ward of the state
* Language preference other than English or Spanish
Performance Evaluation Study for a New Meconium Detection Test

The purpose of this study is to collect amniotic fluid samples from pregnant women. Amniotic fluid samples will be tested for meconium with a new assay. The results will be correlated with other laboratory tests.

Female volunteers will be recruited locally in a single medical center. After the occurrence of amniotic membranes rupture, amniotic fluid samples will be collected extracorporeally.

Meconium concentration levels will be measured by the new test. Other laboratory tests will be employed in order to determine the accuracy of the new test.

Eligibility Criteria:
Inclusion Criteria:

* Provide written or oral informed consent to participate in the study and agree to comply with study procedures.
* Pregnant.
* Intend to seek medical care during pregnancy.

Exclusion Criteria:

* Amniotic fluid samples are mixed with urine.
Open Label Study of ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease

The objective of this study is to determine the safety and tolerability of fosgonimeton (ATH-1017) in subjects with mild to moderate Alzheimer's disease who completed the 26-week randomized treatment in Study ATH-1017-AD-0201 or Study ATH-1017-AD-0202.

This is a multicenter, seamless, open-label extension (OLEX) study of ATH-1017 treatment in subjects with a clinical diagnosis of mild to moderate Alzheimer's disease who completed 26 weeks treatment in the randomized, placebo-controlled, double-blind studies, ATH-1017-AD-0201 and ATH-1017-AD-0202. This OLEX study will provide additional, longer-term safety and tolerability information on ATH-1017 administration up to 48 months in subjects with mild to moderate Alzheimer's disease.

Eligibility Criteria:
Inclusion Criteria:

* Subject has completed the Week 26 visit of either of the two blinded parent studies (ATH-1017-AD-0201 or ATH-1017-AD-0202).
* Reliable and capable support person/caregiver who is willing to accept responsibility for supervising the daily treatment or, if required, administering study drug.
* Subject capable of giving signed informed consent, or by a legally acceptable representative.
* Subjects must be in generally good health.
* Male subjects and their partners must agree to continue to use a double-barrier method of contraception during the study, including the follow-up period, unless the partner is not of childbearing potential.

Exclusion Criteria:

* Subject has experienced a serious adverse event during the parent study, which could present an increased safety risk during the open label extension.
* New diagnosis of severe major depressive disorder even without psychotic features.
* Any subject with formalized delusions or hallucinations.
* Significant suicide risk.
* Newly-diagnosed malignant tumor, except for the following conditions that are stable in the judgement of the investigator:

  * Adequately treated squamous and basal cell carcinoma, or squamous and basal cell carcinoma in situ
  * Prostate carcinoma in situ
Effect of WHO Surgical Safety Checklist and Anesthesia Equipment Checklist on Patients Outcomes in Low-resource Settings.

The study to investigate the effectiveness and the current perception of safety checklists in Ukrainian hospitals.

A prospective multicenter study was conducted in 6 large Ukrainian hospitals: Kyiv City Clinical Hospitals #1, University Clinic of the Bogomolets National Medical University, Kyiv City Maternity Hospital #5, National Cancer Institute, Shalimov National Institute of Surgery and Transplantology, Saint Martin Hospital in Mukachevo. Institutions were selected among those, where surgical department administration was willing to implement the Safe Surgery Saves Lives campaign recommendations, but has not yet formally introduced the WHO Safe Surgery Checklist. On each study site, 1 or 2 operating rooms were designated for data collection. All surgical procedures observed by the data collectors in those operating rooms were included. The study was conducted in two phases: control period, lasting from February 1, 2022 until August 1, 2022, followed by a week-long educational period during which the WHO Surgical Safety Checklist and the Anesthesia Equipment Checklist were used but no data were collected. The intervention period began on August 8, 2022 and lasted until December 31, 2022. Hospital administration and members of all surgical teams were informed of the nature of the study and the proper checklist use method by the involved anesthesiologists, who were previously instructed by the primary investigators. WHO Surgical Safety Checklists and the Anesthesia Equipment Checklists were provided in the designated operating rooms. Both checklists were translated into Ukrainian. The requirement for written informed consent from the patient was waived by the ethical committee of Bogomolets National Medical University. The study design was approved by the ethics committee of the Bogomolets National Medical University (protocol #148, 07.09.2021).

Eligibility Criteria:
Inclusion Criteria:

* medical institutions with surgical departments

Exclusion Criteria:

* medical institutions without surgical departments
Indian Phenotype Registry

This study is a non-interventional, multicentre observational study to be conducted at 1000 sites in India. The study targets to enrol approx. 50000 patients with approx. 50 patients per site. The study would enrol Diabetes Mellitus patients who provides written informed consent. No study medication will be prescribed or administered as a part of study procedure. Patients, who have been treated as per Investigators' routine clinical practice will be screened for enrolment in study. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).

This study is a non-interventional, multicentre observational study to be conducted at 1000 sites in India. The study targets to enrol approx. 50000 patients with approx. 50 patients per site. The study would enrol Diabetes Mellitus patients who provides written informed consent. No study medication will be prescribed or administered as a part of study procedure. Patients, who have been treated as per Investigators' routine clinical practice will be screened for enrolment in study. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).

This is a single visit cross sectional study however during site feasibility visit, probability of follow-up of these patients will be evaluated. If feasible protocol will be amended to continue data collection prospectively for appropriate duration

Eligibility Criteria:
Inclusion Criteria

1. Male or female patients with 18 years and above.
2. Patients who provide written informed consent.
3. Patients with previously diagnosed with Diabetes Mellitus
4. HbA1C report available within past 3 months

Exclusion Criteria- None
Ambulatory Versus Home Blood Pressure Monitoring in Obstructive Sleep Apnea

Subjects referred to a sleep clinic had polysomnography (PSG), clinic BP measurements, 24-hour ABP monitoring and HBP monitoring using a device (Microlife WatchBP HomeN) that allows daytime (3 days, 2 duplicate readings/day) and automated nighttime BP measurement (3 nights, 3 readings/night).


Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 65 years
* Suspected OSA
* Treated or untreated for hypertension

Exclusion Criteria:

* History of cardiovascular disease (heart failure, coronary heart disease, arrhythmia or stroke)
* History of asthma or chronic obstructive pulmonary disease (FEV1/FVC \<70%)
* History of diabetes mellitus, collagen diseases and sarcoidosis
* Serum creatinine \>1.6 mg/dl, proteinuria
* Previous treatment with CPAP
* Pregnancy or menstruation during the study
* Treatment with steroids, lithium or any other drugs affecting BP
* Change in antihypertensive treatment(if any) in the last 8 weeks before study entry
Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Major Depressive Disorder

This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and safe in the treatment of patients with MDD.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a documented clinical diagnosis of Major Depressive Disorder.
* Be able to understand and comply with the requirements of the study.
* Able to understand and provide written informed consent

Exclusion Criteria:

* Patients (female) must not be pregnant or lactating
* Current or past diagnosis of stroke or transient ischemic attack (TIA).