cyrilzakka/clinical-trials huggingface dataset:
A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy

Phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. The safety and tolerability of the different doses of lacosamide will be investigated.

This phase 2/3 open-label trial is being conducted at approximately 100 sites in the US to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. Approximately 525 subjects will be enrolled. To qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have completed trials SP665, SP742, or SP768 and, in the investigator's opinion, may benefit from long-term administration of lacosamide. Subjects will be titrated to their optimal dose of lacosamide (up to 600mg/day). The safety and tolerability of the different doses of lacosamide will be investigated throughout the trial. In addition, to determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity and pain interference with sleep and activity. Subjects' quality of life will also be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who completed Study SP665, SP742, or SP768 and, in the investigators opinion, might benefit from long-term administration of SPM 927. Exception: subjects who prematurely discontinued Study SP742 or SP768 due to lack of efficacy or due to intolerability to trial medication may be eligible to participate in Study SP745, after consultation with the medical monitor.

Exclusion Criteria:

* Subject has clinically relevant electrocardiogram (ECG) abnormalities, or QT-corrected (QTc) interval \>=500 milliseconds (ms), and/or a QTc interval increase of \>=60ms from the mean pre-dose QTc value at Visit 2 of Studies SP665, SP742 or SP768.
* Subject has aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>=3 times the upper limit of the normal range (ULN) with total bilirubin \>=2 times ULN or transaminases (AST and/or ALT) \>=5 times ULN.
* Subject has a clinically relevant medical condition that, in the opinion of the investigator, jeopardizes or compromises the subject's ability to participate in this trial.
Unique Electroencephalography (EEG) Markers of Habit Behaviors in Obsessive-Compulsive Disorder (OCD)

This study focuses on explaining the occurrence and development of compulsive behaviors from habit hypothesis. Investigators will study both OCD patients and healthy individuals using Hardwick's forced-response time task(2019), the habit Go/No-Go task, and the Intra-Extra Dimensional Set Shift task. Investigators aim to explore the cognitive abilities and differences between OCD patients and healthy controls in these three tasks. Control variables will include participants' levels of anxiety, depression, and stress, as well as sense of incompleteness and intolerance of uncertainty levels. By examining the differences in habit formation and expression abilities between OCD patients and healthy controls, and exploring the specific brain electroencephalographic activity processes in OCD patients, investigators hope to reveal the abnormal neural activity in habit-related circuits in OCD patients. This could provide new insights for the diagnosis and treatment of OCD.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18 and 50;
2. Y-BOCS score greater than or equal to 16;
3. Meet DSM-5 diagnostic criteria with no medication changes in the past two weeks;
4. Right-handed.

Exclusion Criteria:

1. Diagnosed with any DSM-5 disorder other than OCD;
2. Have a major physical illness;
3. Have strong suicidal ideation.
Phenylephrine Versus Tranexamic Acid to Control Bleeding in Patients Undergoing Inferior Turbinoplasty by Coblation

Coblation is a unique method of delivering radio frequency energy to the soft tissue for applications in otolaryngology. It induces reduction of the inferior turbinate by vaporizing and destroying the soft erectile tissue. The volume reduction and tissue fibrosis are immediate and sustainable. Bleeding from the vascular capillary beds of the sinonasal mucosa compromises the surgical field and increases operative time and risk of complications. In this study we try to assist hemostasis with a multifaceted approach, including use of topical vasoconstrictors "phenylephrine" and systemic antifibrinolytic agent "tranexamic acid".


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I and II
* Scheduled patients for Coblation Turbinoplasty surgery with inferior turbinate hypertrophy

Exclusion Criteria:

* Known allergy to study drugs.
* History of coagulopathy or bleeding disorders.
* Patients with hypertension or ischemic heart disease.
* patients on anticoagulants, antiplatelets or NSAIDs
* history of deep vein thrombosis, stroke or peripheral vascular disease.
Bulking Agent Versus Electrostimulation Therapy in Anal Incontinence

Randomized trial with a estimated number of 60 patients with mild or moderate anal incontinence at the clinic Physiology of the Hospital das Clínicas of the Medical School of the University of São Paulo (HC-FMUSP).

* Exclusion criteria: symptoms of anal incontinence for less than six months, with severe anal incontinence, associated external anal sphincter damage, past pelvic radiotherapy, evidence of perineal sepsis, rectal prolapse, anorectal cancer, inflammatory bowel disease, malignant disease Congenital formation, scleroderma, Parkinson's disease, immunosuppression and ongoing gestation. In addition, those patients who do not agree to participate in the survey will be excluded.
* The study will have 4 phases: preoperative, surgical, recent postoperative and later postoperative

* Prospective randomized trial
* Estimated number of 60 patients with mild or moderate anal incontinence with isolated anal sphincter muscle damage or evidence of anal incontinence without verification of anatomical damage to the anorectal sphincter complex with dysfunction or inadequate action of the internal anal sphincter accompanied at the outpatient clinic Physiology of the Hospital das Clínicas of the Medical School of the University of São Paulo (HC-FMUSP).
* Exclusion criteria: symptoms of anal incontinence for less than six months, with severe anal incontinence, associated external anal sphincter damage, past pelvic radiotherapy, evidence of perineal sepsis, rectal prolapse, anorectal cancer, inflammatory bowel disease, malignant disease Congenital formation, scleroderma, Parkinson's disease, immunosuppression and ongoing gestation. In addition, those patients who do not agree to participate in the survey will be excluded.
* The study will have 4 phases: preoperative, surgical, recent postoperative and later postoperative

Eligibility Criteria:
Inclusion Criteria:

* Moderate fecal incontinence

Exclusion Criteria:

* Severe fecal incontinence
* Pelvic radiotherapy
Pretreatment Staging of High-Risk Prostate Cancer With 18F-Fluciclovine PET/MRI

There is great need for improved preoperative imaging in men with high-risk prostate cancer. Investigators propose to develop and validate an optimized simultaneous PET/MRI protocol for local, regional and whole body preoperative staging in a single imaging session using the amino acid PET tracer, F-18 fluciclovine. Despite advances in the diagnosis and treatment of prostate cancer, the preoperative staging of men with prostate carcinoma (PCa) is currently problematic. Conventional imaging is falsely negative for regional lymph node metastases in a substantial fraction of men. In particular, approximately 35% of men with high-risk prostate cancer will have biochemical recurrence even after optimal surgical resection. A major benefit of simultaneous acquisition of a multiparametric prostate MRI (mpMRI) and F-18 fluciclovine PET includes having the patient undergo a single imaging study which provides both anatomic and molecular characterization of the tumor, including metastases which would potentially be missed by conventional anatomic imaging and size criteria. Additionally, simultaneous acquisition will improve co-registration of the PET and MR data which is valuable for small lesions and in anatomically complex regions. Although the use of fluciclovine in the characterization of the primary PCa remains to be established, the anatomic detail provided by conventional mpMRI will complement the detection of small volume metastatic disease by fluciclovine PET. Additionally, the use of hybrid PET/MRI technology allows for the assessment of dynamic tracer uptake and washout during the whole body and regional PET/MRI scan, which may demonstrate the ability to increase detection of the primary PCa on fluciclovine PET. If F-18 fluciclovine PET/MRI can reliably and accurately detect nodal metastases in high-risk prostate cancer patients, surgeons may use this new technology to develop new treatment algorithms for the optimal management of these patients.


Eligibility Criteria:
Inclusion Criteria:

- High-risk biopsy-proven treatment-naïve prostate adenocarcinoma (Gleason score ≥ 8 and/or serum PSA \> 20)

Exclusion Criteria:

* Inability to tolerate or undergo PET/MRI
* Previous or current hematologic or lymphatic disorder (including leukemia, lymphoma, Castleman's disease, etc.)
* Recurrent prostate adenocarcinoma
* Known visceral, osseous, or extrapelvic metastases prior to fluciclovine-PET/MRI
* Known allergy to glucagon or gadolinium-based contrast
Binocular Peripheral Myopic Defocus Using a Clinical Prototype Device

Kubota Vision Inc. has developed a spectacle-like prototype device which is designed to be used as a light-based therapy to reduce myopia progression. In this study, we aim to observe the ocular biometric and refractive changes following binocular part-time wear of the clinical prototype device over a course of 12 months and compare that to 12 months of no clinical prototype device use (control).


Eligibility Criteria:
Inclusion Criteria:

* Spherical equivalent -0.50 to -5.50 diopters
* visual acuity of at least 20/25 in each eye

Exclusion Criteria:

* history of ocular trauma or major eye surgery
* active ocular infection
* any prior history or participation in myopia control treatments within the past 3 months
Accuracy Comparison: Optoelectronic Motion Capture and Markerless System

The purpose of this study was to assess the Openpose reliability to measure kinematics and spatiotemporal gait parameters and to evaluate the minimum technical requirements. This analysis used video and optoelectronic motion capture simultaneously recorded. We assessed more of 20 subject with different motor gait impairments

Marker-based Optical motion tracking is the gold standard in gait analysis, but today, markerless solutions are growing rapidly. Treatment of physical impairments could improve if supported with reliable motion capture. Moreover, the use of markerless technology offers numerous advantages for working with pediatric populations under various conditions. In this paper, we assess the Openpose reliability to measure kinematics and spatiotemporal gait parameters and to evaluate the minimum technical requirements., in a population of children with and without gait impairments. Validating markerless methods can open the way for new motion capture techniques and enhance the accessibility of kinematic measurements and improve the treatment of physical impairments.

Eligibility Criteria:
Inclusion Criteria:

* Age over 4 years;
* Ability to walk independently without walking aids and/or orthoses.

Exclusion Criteria:

* Inability to walk independently and safely for short distances without walking aids and/or orthoses.
Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Pressure Wound Therapy System

The primary purpose of this study is to evaluate the safety and efficacy of the concurrent use of Apligraf® and the SNaP® Wound Care System for the treatment of diabetic and venous stasis lower extremity ulcers.


Eligibility Criteria:
Inclusion Criteria:

* Wound \< 10 cm in greatest diameter
* Wound age \> 4 weeks and patient shows \< 50% wound area healing after 4 weeks of treatment
* Patient \> 18 years of age
* Patient is willing and able to sign consent
* Patient is willing and able to complete study visits and comply with study dressing protocols

Exclusion Criteria:

* Wound size reduction of \> 50% in last 4 weeks of treatment
* Patients with active wound infections, including cellulitis and osteomyelitis
* Patients with wounds not able to have eschar debrided
* ABI \< 0.65 or SPP \< 30mmHg
* Patients with wounds in anatomic areas which preclude achieving an airtight seal for NPWT
* Ulcers due to inflammatory conditions such as rheumatoid arthritis, lupus, scleroderma, vasculitis, calciphylaxis, etc.
* Patients with allergy to or intolerance of any of the wound dressing materials expected to be used during the trial.
* Pregnant patients
* Patients unable to tolerate NPWT
* Patients with dialysis dependent ESRD
* Index ulcer is on the plantar surface of the foot
Earing Protectors Influence on Newborns Preterm Sleep Pattern

Preterm newborn sleep deprivation due to medical interventions and environmental characteristics of the Neonatal Intermediate Care Unit (NICU) can increase morbidity and developmental deleterious effects. The aim of this study is to test the effect of earmuffs on sleep pattern of preterm neonates. Prospective, randomized, controlled, crossover study conducted in NICU of two teaching hospitals from São Paulo, Brazil. The effect of earmuffs use was analyzed through polysomnography measurement during four "Quiet times" periods. It was also analyzed sleep related variables during 24 hours of the day. Preterm newborns characteristics and clinical characteristics were also analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Preterm Newborns inside the incubator;
* Preterm Newborns clinically stable;
* Preterm Newborns with no change in hearing screening test;
* Preterm Newborns current weight between 1200 and 2000g.

Exclusion Criteria:

* Preterm Newborns in phototherapy;
* Preterm Newborns in use of invasive mechanical ventilation and noninvasive;
* Preterm Newborns with any type of congenital malformation;
* Preterm Newborns with periventricular hemorrhage grades II, III and IV;
* Preterm Newborns that received Central Nervous System depressant medication and sedative opioid analgesics in the last 24 hours;
* Preterm Newborns using corticoids;
* Preterm Newborn whose mother has a history of illicit drug use during pregnancy
Ketamine Versus Lidocaine Nebulization for Awake Fiberoptic Intubation

This randomized double-blinded study is performed to compare ketamine versus lidocaine for nebulization for awake nasal fiberoptic intubation as regard efficacy and side effects.

Difficult airway is one of the major challenges facing anesthesiologists. This challenge is compounded when the patient is treated while awake. The additional burden is to complete this procedure comfortably thus ensuring patient cooperation which is a vital part of successful performance. Several methods have been tried in literature to facilitate awake intubation by fiberoptic bronchoscope (FOB)

This randomized double-blinded study is performed to compare ketamine versus lidocaine for nebulization for awake nasal fiberoptic intubation as regard efficacy and side effects.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I and II of both sexes with body weight from 60-90 kg, and planned for elective awake nasal fiberoptic intubation due to expected difficulty in airway management (e.g. limited mouth opening, trismus, mandibular/ maxillary swellings or tumors, ludwig's angina, or other indications).

Exclusion Criteria:

* body weight \< 60 kg or \> 90 kg
* uncooperative, with mental or psychological problems
* known allergy to any of the study drugs
* pregnancy
* hypertension
* cardiac disease
* liver or renal impairment
* epilepsy,
* asthmatic,
* previous bad experience of awake intubation,
* emergency operations or
* coagulation abnormalities
Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Severe Post-stroke Hemiparesis

Individuals who experienced a stroke over one year ago will be randomly assigned to receive 1 of 4 different conditions of brain stimulation. All individuals will receive therapy of the hand and arm following the stimulation. This study will try to determine which brain stimulation condition leads to the greatest improvement in hand and arm function.

This study will look at the effects of a painless, non-invasive form of brain stimulation, called transcranial direct current stimulation, or tDCS. tDCS is thought to increase the brain's ability to change. Participants will be assigned to one of four groups by chance. Three groups will receive tDCS at a level expected to increase the brain's ability to change, and will vary by the areas of the brain that are stimulated. The fourth group will receive tDCS at a level not thought to affect the brain's ability to change. All participants will receive intensive therapy of their impaired arm and hand, focusing on exercises that will improve their ability to function in daily life.

Eligibility Criteria:
Inclusion Criteria:

* 12 or more months post-stroke
* Inability to extend the affected metacarpophalangeal joints at least 10 degrees and the wrist 20 degrees

Exclusion Criteria:

* Addition or change in dosage of drugs known to exert detrimental effects on motor recovery within 3 month of enrollment
* Untreated depression
* History of multiple strokes

Exclusion criteria for TMS evaluations:

* History of head injury with loss of consciousness
* History of severe alcohol or drug abuse, or psychiatric illness
* Positive pregnancy test or being of childbearing age and not using appropriate contraception
* Presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure and surgical clips in or near the brain
* Cardiac or neural pacemakers
Safety and Immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine (VEE C-84) as a Booster to VEE TC-83

The study is designed to assess the safety and immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination.

Study Objectives:

Primary:

To assess safety of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination as a single dose or a three-dose series, and To assess immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination as a single dose or a three-dose series

Secondary:

To assess incidence of VEE infection in C-84 boosted personnel.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old.
* VEE PRNT80 \< 1:20 before immunization.
* (females) Negative urine pregnancy test on the same day before vaccination. Not planning pregnancy for 3 months.
* Actively enrolled in the SIP.
* At risk for exposure to virulent VEE virus (with up-to-date risk assessment).
* Previous TC-83 vaccination
* Up-to-date (within 1 year) physical examination/tests.
* Sign and date the approved informed consent.
* Willing to return for all follow-up visits.
* Agree to report adverse event (AE) up to 28 days after vaccination.

Exclusion Criteria:

* Over age of 65 years
* Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B carrier state, or elevated liver function tests.
* History of immunodeficiency or current treatment with immunosuppressive medication.
* (females) Currently breastfeeding.
* Confirmed human immunodeficiency virus (HIV) titer.
* Any known allergies to components of the vaccine.
* A medical condition that in the judgment of the Principal Investigator (PI) would impact subject safety (i.e-vaccination and or exposure to another alphavirus).
* Administration of any vaccine within 28 days of C-84.
* Any unresolved AEs resulting from a previous immunization.
Closed-loop Versus Conventional Ventilation Mode During Mobilization Period in Critical Care Patients

Nursing is essential in critically ill patients care but with high risk of hypoxia, especially during mobilization. Full closed-loop control ventilation is well established for her safety in unselected ventilated critical care patients with different lung conditions compared to conventional ventilation.

The aim of this study is to assess the ability of a full closed-loop control ventilation (Intellivent-ASV, TM) to reduce hypoxia during mobilization period in unselected ventilated patients.

Prospective randomized cross over study including all consecutive ventilated patient with predicted duration of ventilation \> 48 hours, inspired oxygen fraction \< 60% and without neuromuscular blocking agent.

Patient were randomized to be ventilated with full closed-loop control or conventional ventilation 30 minutes before the first nursing period after inclusion. The ventilator was switched in the other mode (conventional or full closed-loop respectively), 30 minutes before the following nursing period. Between this two consecutive nursing periods, ventilation mode is choosed by the attending physician.

The primary outcome was the oxygenation measured by pulse oxymetry during the nursing periods.

Eligibility Criteria:
Inclusion Criteria:

* Invasive mechanical ventilation for expected time \>48h

Exclusion Criteria:

* Pregnancy
* Neuromuscular blocking agent (discontinuous or continuous) infusion
* Inspired oxygen fraction (FiO2) setting \> or = 60%
* Mobilization contraindication (hemodynamic instability, unstable vertebral trauma, etc.)
* Neurological breathing (patients with brain injury)
* Pulse oxymetry monitoring unavailable
* Expected ventilation weaning \<24h after randomization.
* Moribund patients