cyrilzakka/clinical-trials huggingface dataset:
Patient Outcomes Evaluation of the EBI Vuelock™ Anterior Cervical Plate System

To prospectively collect radiographic and outcome data on patients who are having cervical spine fusion surgery with the VueLock™ Anterior Cervical Plate System

The purpose is to prospectively collect radiographic and outcome data on patients who are having cervical spine fusion surgery with the VueLock™ Anterior Cervical Plate System.

Eligibility Criteria:
Inclusion Criteria:

1. The patient will undergo anterior cervical fusion with the VueLock™ Anterior Cervical Plate System for treatment of degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma, tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusion.
2. The patient must be available for follow-up during the study.
3. The patient must be skeletally mature (epiphyses closed).

Exclusion Criteria:

1. Patients with other pathology at the involved spinal level, e.g., osteomyelitis, Paget's disease, pathologic fracture, etc.
2. Patients with a disease entity or condition that totally precludes the possibility of bony fusion such as known active cancer, etc.
3. Pregnant or nursing females.
4. Patients who in the opinion of the investigator would be psychologically unwilling or unable to understand or complete the protocol, especially those unwilling or unstable to participate in the follow-up.
A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.

The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC seizure frequency and that pregabalin will be safe and well tolerated.


Eligibility Criteria:
Inclusion Criteria:

* Seizures classified as Primary Generalized Tonic Clonic Seizures
* Must have at least 1 PGTC seizure in the 8 weeks prior to screening
* Must have a minimum of 3 PGTC seizures during the 8-week baseline phase and at least 1 PGTC in each 4-week period of the baseline phase
* Currently receiving adequate and stable dosage of 1 to 3 anti-epileptic treatments (stable within 28 days of screening)
* Signed informed consent and assent if a minor
* Ability to comply with daily seizure and dosing diary requirements and all study procedures

Exclusion Criteria:

* A current diagnosis of febrile seizures, or seizures related to an ongoing acute medical illness
* Focal seizures (simple partial, complex partial, or partial becoming secondarily generalized)
* Status Epilepticus within 1 year prior to screening
* Lennox-Gastaut syndrome, infantile spasms, Benign Epilepsy with Centrotemporal Spikes (BECTS) and Dravet syndrome
* Seizures related to drugs, alcohol, or acute medical illness
* Any change in anti-epileptic treatment regimen (type of medication or dose; VNS alteration) within 28 days of the screening visit or during the baseline phase
* Progressive or potentially progressive structural CNS lesion or a progressive encephalopathy.
* Progressive inborn errors of metabolism.
A Study to Assess the Safety and Risk of Hypersensitivity Reactions of Sulbactam-durlobactam in Adults With Acinetobacter Baumannii-calcoaceticus (ABC) Complex Infection

The goal of this observational study is to evaluate the safety of sulbactam-durlobactam, as well as the risk of hypersensitivity reactions (including anaphylaxis) in participants with Acinetobacter baumannii-calcoaceticus complex infection. Participants will be followed for approximately 28 days in order to collect safety and reaction data.


Eligibility Criteria:
Inclusion Criteria:

* Participant is ≥18 years old at the time of written informed consent and is hospitalized.
* Participant has provided the written informed consent. If a participant is unable to provide written informed consent due to their medical condition, the participant's legally authorized representative may consent on behalf of the participant, or the decision can be made according to the procedure permitted by local law and institutional standard operating procedures (SOPs).
* Participant has a proven or strongly suspected diagnosis of an infection caused by susceptible ABC isolates, based on investigator's clinical judgment.
* Participant initiates treatment with SUL-DUR per routine clinical care. Participants who receive SUL-DUR within 24 hours prior to enrollment are also eligible to participate. The decision to treat the participant with SUL-DUR is made prior to and independently of study participation.
* The participant has an expected survival of \>48 hours at the time of written informed consent.

Exclusion Criteria:

* A history of significant hypersensitivity or allergic reaction to any β-lactam, or any contraindication to the use of β-lactam antibiotics
Influence of Tonic and Burst Transcranial Magnetic Stimulation (TMS) Characteristics on Acute Inhibition of Subjective Tinnitus

Transcranial magnetic stimulation (TMS) is already broadly used in different areas of neuroscience research. Last year, special attention was drawn to TMS in tinnitus. The aim of the researchers' study is to investigate the stimulation characteristics of TMS in tinnitus patients, in particularly the effect of tonic and burst stimulation of the superior temporal lobe.


Eligibility Criteria:
Inclusion Criteria:

* Patients presented to our Multidisciplinary Tinnitus Clinic with tinnitus as a main complaint.

Exclusion Criteria:

* Patients with known history of epilepsy, pacemakers, cochlear implants, neurostimulators or intracerebral pathology were excluded from the study.
Indirect Ultrasonographic Findings for Parametrial Involvement in Deep Endometriosis

This study evaluated the use of ultrasonographic findings as a first-line imaging tool to raise indirect suspicion of parametrial involvement in women suspected of having severe endometriosis (DE).

Ultrasonographic findings will be conventionally divided in:

* concomitant DE nodules
* indirect DE signs

Eligibility Criteria:
Inclusion Criteria:

* patients with suspected deep endometriosis undergoing surgical approach

Exclusion Criteria:

* patients with a previous surgical diagnosis of endometriosis
* pazients with radiological evidence of parametrial endometriosis
* patients who could not undergo transvaginal and/or transabdominal ultrasound for any technical reason
Electrical Stimulation of Cutaneous Lesions

Skin lesions, such as chronic ulcers and burns, represent a serious public health problem due to high government costs, and scarce successful conservative treatments.There is a growing scientific literature on the use of electrotherapy in the process of wound healing, but in return there is a dearth of scientific studies on the use of various types of currents and the different parameters in the proposed treatments.

This project proposes the use of polarized currents to increase the speed of healing in chronic ulcers and donor sites in burn patients. Will be included 30 patients with chronic ulcers and 30 burn patients undergoing skin graft surgery, will be randomized into control and treated groups. For the ulcer chronic group treatment will be with 50 minutes high voltage and 10 minutes diadynamica current and the burn group only 50 minutes high voltage current.

Eligibility Criteria:
Inclusion Criteria:

* all patients admitted to the rehabilitation center of Clinical Hospital with chronic ulcer, Faculty of Medicine of Ribeirão Preto / USP, in the period between january 2010 and december 2011
* all patients admitted to the Burns Unit of Clinical Hospital, Faculty of Medicine of Ribeirão Preto / USP, in the period between march 2011 and december 2012

Exclusion Criteria:

* Infection
* weight below 16kg
Molecular Imaging of Active Venous Thrombus With Positron Emission Tomography (PET)

Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and/or pulmonary embolism (PE), is a major public health issue. VTE is the third most common acute cardiovascular pathology, after myocardial infarction and stroke.

Diagnostic accuracy is essential in the case of VTE, in order to select patients for whom anticoagulant treatment is necessary, and to avoid long-term treatment of patients who will derive no benefit from it.

The management of patients with suspected PE is based on diagnostic strategies that use either ventilation-perfusion planar lung scintigraphy or thoracic angioscanner imaging as the cornerstone. These 2 techniques correspond to what might be termed "negative" imaging, i.e. visualization of the vascular repercussions downstream of an obstruction, whatever its nature.

A research prospect in the field of VTE diagnosis is the direct marking of the various elements of the active venous thrombus, which could correspond to "positive" thrombus imaging.

Numerous studies have already investigated the role of molecular imaging in the diagnosis of VTE, especially in the diagnosis of DVT. However, these studies used conventional scintigraphy to evaluate these tracers, a technique lacking in sensitivity and with insufficient spatial resolution.

Nuclear medicine and molecular imaging have undergone a technological revolution since the early 2000s, with the development of positron emission tomography (PET). The technical advantages of PET over conventional scintigraphy include greater sensitivity and higher spatial resolution (4 mm for PET vs. 12 mm for conventional scintigraphy), which may have been the limiting factor in studies already carried out.

The aim of this project is to develop a new radiopharmaceutical for use in PET scans, a biomarker of active venous thrombus, with a view to improving the diagnosis of MVTE and hence patient management.


Eligibility Criteria:
Inclusion Criteria:

Major patient (≥18 years), voluntary blood donor, with no notable medical history altering coagulation (i.e. known thrombophilia, active cancer), no chronic pathology, no current treatment.

Exclusion Criteria:

Minor patient (\<18 years); known chronic pathology; long-term treatment including anti-platelet aggregation therapy or anticoagulant treatment, refusal to participate.
Atropine (0.02%, 0.04%) Combined With Defocus DIMS for Moderate and High Myopia Control

To evaluate the effectiveness and safety of DIMS, low concentration atropine eye drops,and atropine combined with DIMS in controlling axial length and refraction in children with moderate to high myopia.

In this study, stratified block randomization was employed for random grouping, and the total sample size required as calculated was 410 individuals. Firstly, 410 subjects were assigned ID numbers ranging from 1 to 410. SPSS.26 statistical software was utilized to apply the "random number generator" by setting the "fixed seed number" to "20231121", and subsequently generate random numbers. Once the random numbers were obtained, random sampling and grouping were conducted. This study was a multicenter trial, with block randomization stratified by center. The total sample size of 410 was distributed across 4 cities, and the samples collected in each city were randomly allocated into 5 treatment groups (groups A, B, C, D, and E), with approximately 20 individuals in each group.

Eligibility Criteria:
Inclusion Criteria:

* School-age children aged 6 to 12 years (including boundary value)
* Children with moderate or high myopia (subjective refraction after cycloplegia: -9.00D≤spherical equivalent (SE)≤-3.00D, with-rule astigmatism (C)≤2.00D, against-rule astigmatism (C)≤1.00D, anisometropia of both eyes≤2.50D)
* Binocular best corrected visual acuity (BCVA)≥0.8 (five-point visual acuity 4.9)
* Agree with the study scheme and sign the informed consent
* Note: if both eyes meet the inclusion criteria, the eye with higher spherical equivalent is the study eye; if one eye meets the inclusion criteria, the eye is the study eye.

Exclusion Criteria:

* Used or currently using orthokeratology, multifocal contact lenses, defocusing framework lenses, atropine eye drops and other myopia control means in the past month; used red light treatment in the past
* Children with obvious strabismus and amblyopia
* With congenital eye disease, such as congenital cataract, congenital retinal disease
* Secondary myopia (such as premature retinopathy or other eye diseases in infants and children caused secondary myopia), or myopia combined with systemic syndrome (such as Marfan syndrome)
* Had internal eye surgery (such as cataract extraction, intraocular lens implantation, anti-glaucoma surgery, etc.)
* Refractive medium opacity (such as corneal disease, crystal opacity, etc.)
* Bnormal intraocular pressure and clinical significance (IOP \&lt;10 mmHg or IOP \&gt;21mmHg or binocular IOP difference ≥5mmHg)
* Fundus chorioretinopathy (except for high myopia fundus degenerative changes) or other intraocular diseases
* Optic nerve damage or congenital optic nerve dysfunction
* Can not be regularly checked
* The adjustment range is less than 8D or obvious near difficulties
* Other reasons researchers think it is not suitable for inclusion in researchers
Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene

The purpose of this research study is to:

* see if gefitinib pills can shrink Stage 1 or 2 non-small cell lung cancers before surgery
* see if your non-small cell lung cancer has a mutation in a certain part of the EGFR gene
* see if patients whose tumor does shrink with gefitinib treatment are more likely to have a mutation in a certain part of the EGFR gene
* see if the pattern of protein expression in the blood is related to the tumor's sensitivity or resistance to gefitinib treatment.
* see if expression of certain genes in the tumor are related to the tumor's sensitivity or resistance to gefitinib treatment.

This is a phase II, single institution trial to correlate gefitinib response and mutations in the protein-tyrosine kinase domain of the EGF receptor gene. The study will be conducted in patients with Stage I and II NSCLC who have been determined to be operable and resectable.

Patients must have 1 or more of the following features: never smoker or smoking history of \< 15 pack years and/or features of bronchioloalveolar lung cancer. 50 patients will be enrolled on this study. Treatment will be with gefitinib for at least 21 days before surgery (depending on the timing of the surgery). Patients will discontinue gefitinib 2 days before their operation. For patients that demonstrate a radiographic response to gefitinib preoperatively and /or patients with mutations in the protein-tyrosine kinase domain of the EGF receptor gene (identified from the surgical sample), gefitinib will continue for 2 years post-surgery. Patients who do not have evidence of radiographic response or mutations in the protein-tyrosine kinase domain of the EGF receptor gene will be removed from the study.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic confirmation of malignancy at Memorial Sloan-Kettering
* Patients must have previously untreated stage I or II NSCLC (T11-2N0M0, T1-2N1M0, T3N0M0) and 1 of the following features: never smoker or \< 15 pack year smoking history and/or bronchioloalveolar cancer (either pure BAC, BAC with focal invasion or adenocarcinoma with BAC features)
* Patients must have been determined to be operable and resectable by the treating thoracic surgeon.
* Age \>18 years.
* Measurable indicator lesions
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Pregnant or lactating women or women of childbearing potential not using effective contraception. Men participating in the trial must also use effective contraception when sexually active.
* Patients may not be receiving any other investigational agents.
* Any history of or evidence of interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).
Mobile App Intervention for Sleep Problems and Alcohol Use Among Veterans

The goal of this clinical trial is to test the preliminary efficacy of a brief mobile app targeting insomnia symptoms among veterans. In this study, we will enhance the mobile app, Insomnia Coach, with content from brief alcohol interventions to help veterans reduce both insomnia symptoms and alcohol use behaviors. We will compare those veterans who are randomly assigned to receive this brief mobile app intervention to those who receive a control condition. This will help us determine if veterans randomly assigned to receive the intervention experience greater improvement on outcomes compared to those who do not receive the intervention. The study involves a beta-test phase of the app to ensure feasibility and acceptability by veterans, followed by a randomized controlled trial with 130 veterans who meet criteria for insomnia and alcohol use disorder.


Eligibility Criteria:
Inclusion Criteria:

* U.S. veteran aged 18 or older separated or discharged from service in the Air Force, Army, Marine Corps, Navy, or Coast Guard
* Not currently affiliated with active duty service or on active reserves or guard service
* Served since September 11, 2001
* No past 6-month treatment for alcohol or drug use or insomnia
* Alcohol Use Disorder Identification Test (AUDIT) score of 8 or higher
* Insomnia Severity Index (ISI) score of 10 or higher

Exclusion Criteria:

* Positive screening for other substance use disorders (not including cannabis use disorder)
Initial Clinical Experience With the MONARCH Platform, Urology for the Treatment of Kidney Stones

The purpose of this study is to collect descriptive performance data using the MONARCH Platform, Urology (a novel robotic device) to perform mini-percutaneous nephrolithotomy (kidney stone removal) procedures. Data gathered from this study will be used to optimize the robotic platform and inform training and education material for the future users.


Eligibility Criteria:
Inclusion Criteria:

* Simple renal caliceal and/or pyelo stone(s), greater than or equal to (\>=) 10 millimeter in size identified on computerized tomography (CT) scan, and appropriate for Percutaneous nephrolithotomy (PCNL) treatment according to American Urological Association (AUA) guidelines
* Normal upper tract anatomy, amenable to PCNL and ureteroscopy
* Body mass index less than (\<) 40 kilogram-meter squared
* Participants with a percutaneous tract length \<15 centimeter as measured by the estimation of the skin to stone or skin to appropriate calyx for treatment through a CT scan
* Participant is an appropriate candidate for a mini-PCNL based on the clinical guidelines and investigator assessment

Pre-Operative Exclusion Criteria:

* Any medical or physical condition/limitation that would contraindicate a conventional ureteroscopy or PCNL \[for example, atypical interposition of visceral organs (bowel, spleen, or liver)\] in the supine position. This assessment will be made by the investigator team
* Participation in any other clinical trial 30-days before and throughout the duration of the study that might impact the results
* A solitary functioning kidney
* Female subjects who are pregnant or nursing or those of childbearing potential refusing a pregnancy test
* Presence of ureteral impacted stones
* Presence of ureteral obstruction
* Presence of untreated urinary tract infection, urosepsis
* Inability to give consent
* Presence of a renal mass which has not been investigated
* Staghorn stone
* Participant has an electrically or magnetically activated implanted medical device
* Significant pharmacological anticoagulant therapy or uncorrected bleeding diathesis
* Tumor in the probable access tract area and potential malignant renal tumor

Intra-Procedure Exclusion Criteria:

- Any presenting condition discovered intra procedurally that in the opinion of the investigator would make participating in this study not in the participant's best interest. For example, participants no longer considered good candidates for a mini-PCNL procedure for the removal of the kidney stones.
Stretching Exercises on Symptoms of Primary Dysmenorrhea

The purpose of this study was to assess the effect of active stretching exercises on reducing pain and the quality of life during menstrual cycle in young adult females.

Thirty females with primary dysmenorrhea, aging between 18 to 23 years with BMI of 20-29.9 kg/m2, have a regular menstrual cycle length 28-30 day and cycle bleed from 3 to 7 days, were randomly assigned into three equal groups; two interventions groups (supervised and non-supervised active stretching exercise program) and one control group. The intervention group A practiced a 30 to 45-minute supervised active stretching program three times a week for four weeks, while the other intervention group B practiced non-supervised active stretching home program and the control group C . Visual Analog Scale (VAS) was used to measure pain intensity, and Verbal Multidimensional System (VMS) for measuring menstruation characteristics and the effect of pain on quality of life, before (pre) as well as after (post) 4 weeks at the end of the study .

Eligibility Criteria:
Inclusion Criteria:

* BMI of 20-29.9 kg/m2,
* regular menstrual cycle
* length 28-30 day
* cycle bleed from 3 to 7 days,

Exclusion Criteria:

* contraindication to stretching exercise
* taking any hormonal medications:
* smoker
Study of Aripiprazole in Patients With Bipolar I Disorder

The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of bipolar I disorder, manic or mixed episode

Exclusion Criteria:

* First manic or mixed episode
* Allergic, intolerant, or unresponsive to lithium and valproate or to aripiprazole
* Participation in a previous clinical trial within the past month or ever participated in a trial with aripiprazole