cyrilzakka/clinical-trials huggingface dataset:
Prospective Analysis of EnVisio Spatial Intelligence for Soft Tissue Localization and Guided Surgical Excision

Observational study. The purpose of this study is to evaluate the use of real-time surgical navigation for the localization and surgical removal of soft tissue tumors. The goal is to collect information about the efficiency and effectiveness of the EnVisio Surgical Navigation for intraoperative guidance to obtain negative margin on initial specimen.

Prospective Patient Study: 200 consecutive patients

Objectives

1.) To collect data throughout clinical patient workflow for evaluation of.

1. localization with SmartClip(s)
2. negative margin on primary specimen
3. specimen assessment
4. length of operation

The EnVisio® Navigation System was cleared as a Class II device by the FDA under 510(k) number K183400. The SmartClip® Soft Tissue Marker was cleared by the FDA under 510(k) number K180640.

Principal Investigator will receive monthly EnVisio system data from Company representative on the EnVisio system data collection for procedural cross reference resulting in.

* Date
* Time of SmartClip(s) auto detection
* Color and Number of SmartClip(s)
* Total time of EnVisio Guidance
* Specimen Assessment recordings of SmartClip to specimen edge as recorded by electrocautery tip on identified margin Medial/Lateral/Superior/Inferior/Anterior/Posterior)

Data will be collected from procedures performed including all imaging, clinical and pathologic outcomes. Pre and Post procedure data including number of individual lesions, localization of mass and number of SmartClips used. Patients planning surgical excision of an imaging identifiable in-breast will be offered entry into this study; the AdventHealth Winter Garden location will provide standard informed consent form for the purposes of this study. The projected accrual for this study is 200 patients in total.

Eligibility Criteria:
Inclusion Criteria:

* Patient has image identifiable lesion.
* Patient has selected breast conservation therapy IE: lumpectomy +/-radiation therapy, +/- chemotherapy +/- hormonal or targeted therapies. Neoadjuvant chemotherapy is not an exclusion criterion.
* Patient will be undergoing target tissue localization with the SmartClip
* Patient will be undergoing BCS Breast Conserving Surgery treatment for DCIS or invasive breast cancer with EnVisio ® Navigation System.
* Patient must be age \> or = 18 years.
* Patients unable to provide consent to surgery must have authorized representative provide consent.

Exclusion Criteria:

* Patients undergoing mastectomy for resection of the targeted lesion.
* Patient is localized with an alternative method.
* Patient that are pregnant.
Liprotamase Efficacy Trial in Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency

This is a clinical trial which will evaluate the efficacy of Liprotamase treatment in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (PI).

This trial is divided into four distinct periods:

1. Baseline Period during which each patient is taken off pancreatic enzyme medications.
2. An Open-Label Treatment Period during which all patients will receive ALTU-135 (liprotamase).
3. Inpatient, Double Blind Treatment Period during which half of patients will be withdrawn from treatment and will receive Placebo.
4. Second Open-Label Treatment Period during which all patients will resume treatment with ALTU-135 (liprotamase).

Eligibility Criteria:
Inclusion Criteria:

* Females of childbearing potential must be willing to use birth control
* Diagnosis of CF based upon the following criteria:

  * two clinical features consistent with CF; and

    * either genotype with two identifiable mutations consistent with CF, OR
    * sweat chloride \>60 mEq/L by quantitative pilocarpine iontophoresis
* Clinically stable with no evidence of acute upper or lower respiratory tract infection
* PI determined by fecal elastase \<100 µg/g stool measured at screening
* Able to take pancreatic enzyme supplementation in the form of capsules
* Able to perform the testing (e.g., stool collections) and inpatient stays required for this study, as judged by the Investigator
* Baseline coefficient of fat absorption (CFA) less than or equal to 80%

Exclusion Criteria:

* CFA \>80% at Baseline
* Pregnancy, breastfeeding or of childbearing potential and not willing to use birth control during the study
* History of fibrosing colonopathy
* History of liver transplant, lung transplant or significant surgical resection of the bowel
* Any acute or chronic diarrheal illness unrelated to PI
* Unable to discontinue enteral tube feedings during the study
* Known hypersensitivity to food additives
* Inability to consume the diet required by the study, in the judgment of the Investigator
* Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to screening
* Abnormal liver function (except for patients with Gilbert Syndrome)
* Signs and/or symptoms of liver cirrhosis, portal hypertension or documented liver disease unrelated to CF
* Distal intestinal obstruction syndrome (DIOS) in the last six months prior to screening
* Unable to discontinue the use of pancreatic enzymes
* Any condition that the Investigator believes would interfere with the intent of this study or would make participation not in the best interest of the patient
* Patient is unlikely to complete the study, as determined by the Investigator
The Effect of Using Desensitizers Containing S-PRG In Treatment Of Dentin Hypersensitivity Over 6 Months: A Randomized Clinical Trial

The goal of this clinical trial is to compare the effect of desensitizer containing S-PRG have similar effect as sodium fluoride with functionalized tri-calcium phosphate containing desensitizer in relieving dentinal hypersensitivity in adult patients for six months follow-up. patients will be asked to report pain degree on the visual analogue scale (VAS) along the follow up periods on both groups.


Eligibility Criteria:
Inclusion Criteria:

* Good oral hygiene.
* Cooperative patients who show interest to participate in the study and welling to sign the informed consent.
* Healthy patients with no history of previous systematic diseases that can affect their oral health.
* Normal and healthy gingival tissue.
* Teeth that have no cavitation or restorations.
* Patients with at least 20 natural permanent teeth and at least two teeth with a VAS score from 4 to 10.
* Anterior teeth.

Exclusion Criteria:

* Allergic to the ingredients used in the study.
* Gastrointestinal disorders (They have repeated vomiting attacks).
* Medically compromised (They cannot tolerate the procedures).
* Taking desensitizing treatment in the last 6 months (It affects the outcome).
* Taking anti-inflammatory drugs (It affects the hypersensitivity perception).
* Pregnant females (They complain from nausea and repeated vomiting attacks)
* Smokers (Smoking will affect the oral hygiene and periodontal health).
Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers

This study will be to compare the pharmacokinetics of nalmefene administration intranasal with and without an absorption enhancer compared to an intramuscular injection.

This study will be an inpatient, double-blind, randomized, crossover study involving 14 healthy volunteers. Each subject will receive 4 treatments during the 4 dosing periods.Subjects will stay in the inpatient facility for 17 days to complete the entire study and be discharged following completion of discharge procedures at the end of the last period. Subjects will be called 3 to 5 days after discharge to inquire concerning adverse events and concomitant medications since discharge. After obtaining informed consent, subject will be screened for eligibility. ON the day after clinic admission, subjects will be administered the intranasal-formulated drug in randomized order with 4 days between doses; the intramuscular dose will be administered during the fourth (last) treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 to 55 years of age
* Provide written informed consent
* Body Mass index (BMI) ranging from 18 to 32 kg/m2
* Adequate venous access
* No clinically significant concurrent medical conditions
* Males subjects must agree to use an acceptable method of birth of contraception with female partners as well as not to donate sperm throughout the study and for 90 days after the last study drug administration
* Female subjects of child bearing potential must agree to use an acceptable method of birth control from the start of screening until 30 days after completing the study. Oral contraceptives are prohibited
* Agree not to ingest alcohol, drinks containing xanthine \>500 mg / day (e.g., Coca Cola, tea, coffee, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study

Exclusion Criteria:

* Please contact the site for more information
Oxygen Desaturation During Hemodialysis

Hemodialysis patients may experience drops in blood oxygen saturation during the hemodialysis treatment, which may lead to hypoxia in the tissues.

The investigators hypothesize that:

1. The cumulative number, severity, or other characteristics of such deoxygenation episodes may be a predictor of adverse outcomes in hemodialysis patients.
2. There may be demographic, anthropometric, clinical, treatment prescription, lab analytical, and other parameters that correlate with the number and severity of deoxygenation episodes and, therefore, may be used for risk stratification. Further, some of these parameters may be modifiable.


Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis patient

Exclusion Criteria:

-
Study Evaluating the Duration of Immunity in Healthy Adult Volunteers Who Completed Study 6108A1-500

Upon completion of participation in the 6108A1-500 study, subjects will be asked to consent for this duration of immunity study to provide up to two additional blood samples. SBA \& IgG testing will be done on these samples taken at 6 \& 12 months. The sites participating in this duration of immunity study are the same sites participating in the 6108A1-500 study.


Eligibility Criteria:
Inclusion Criteria:

* Completed study 6108A1-500 (three doses administered and visit 9 completed).

Exclusion Criteria:

* Bleeding diathesis or condition associated with prolonged bleeding time.
* Any clinically significant chronic disease that, in the investigators judgment may be worsened by blood draw.
Pain After Root Canal Obturation With Sealer Containing or Not 1% Enoxolone

This study aims to assess the efficacy of a zinc oxide eugenol sealer containing Enoxolone, a non-steroidal anti inflammatory drug (NSAID) on the pain relief after endodontic treatment.

The study design is a multicenter, doubled blinded randomized controlled trial. The comparator is the equivalent zinc oxide eugenol sealer without NSAID (allocation ratio is 1:1). The conventional endodontic treatment, using gutta percha and sealer, is done. Patients assess their pain for 7 days after permanent root obturation.


Eligibility Criteria:
Inclusion Criteria:

* male or female aged from 18 to 70 years,
* patient requiring root canal treatment on permanent mature teeth (single rooted teeth, premolar or molar),
* Informed consent signed,
* Patient with social protection.

Exclusion Criteria:

* root canal retreatment,
* root canal treatment on an immature tooth,
* calcified root canal assessed radiographically,
* Patient with one or more documented contraindication to endodontic treatment,
* Patient who takes regular analgesic or anti-inflammatory therapy for another pathology,
* Known allergy to NSAID or to one component of the sealer formula,
* Participation to another clinical trial at the same time,
* known pregnancy or lactation,
* Patients with legal protection.
Noise in Critical Care Units.Impact on Critically Ill Patients and Healthcare Personnel

Study noise level in the ICU and its effect on both patients and healthcare personnel.

Use music and study same effects on same patients and healthcare personnel.

Level of noise is measured and investigate its effects on delirium prevalence. sleep quality score. hemodynamics of patients.

burnout and depressive symptoms of healthcare personnel

Eligibility Criteria:
Inclusion Criteria:

* patients admitted to ICU fully conscious and can answer the questionnaires of the study

Exclusion Criteria:

* confused patients
A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Indonesia

This study is conducted in Asia. The aim of this non-interventional study is to evaluate the current status of diabetes management, control, and complications in diabetic subjects in Indonesia.


Eligibility Criteria:
Inclusion Criteria:

* People with type 2 diabetes mellitus (DM) who are being treated, with any of the non-pharmacological or pharmacological options, at a particular centre for at least 1 year and who have visited the centre within the last 3-6 months
* Patients willing to sign informed consent form

Exclusion Criteria:

* Previous participation in this study
* Unable to comply with protocol requirements
* Confirmed or suspected pregnancy
A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis

The primary objective of this study is:

- To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA).

The secondary objectives of this study are:

* To assess the effects of ALX-0061 on quality of life, the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061 and to explore potential dose regimens for ALX-0061 monotherapy, based on safety and efficacy, for further clinical development.
* To obtain parallel descriptive information concerning the efficacy and safety of tocilizumab (TCZ) s.c. in the same clinical trial RA population.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA (according to the 2010 EULAR/American College of Rheumatology (ACR) classification criteria) for at least 6 months prior to screening, and ACR functional class I-III.
* Received previous or current treatment with methotrexate (MTX), and is considered intolerant to MTX, or for whom continued treatment with MTX is inappropriate or has contraindications for MTX use.
* Subjects must not have received MTX for at least 4 weeks before first administration of the study drug.
* Have active RA with at least 6 swollen and 6 tender joints(66/68 joint count) at the time of screening and baseline
* Others as defined in the protocol

Exclusion Criteria:

* Have been treated with DMARDs (Disease Modifying Antirheumatic Drugs)/systemic immunosuppressive drugs during the 4 weeks, or 12 weeks for hydroxychloroquine, chloroquine, or leflunomide (except when an adequate wash-out procedure for leflunomide was completed), prior to first administration of study drug.
* Have received approved or investigational biological or targeted synthetic DMARD therapies for RA (including tumor necrosis factor alpha-inhibitors, abatacept, rituximab, or Janus kinase \[JAK\]-inhibitors) less than 6 months prior to screening.
* Have a history of toxicity, non-tolerance, primary non-response or inadequate response to a biological therapy, or targeted synthetic DMARDs (including JAK inhibitors), for RA.
* Have received prior therapy blocking the interleukin-6 (IL-6) pathway, at any time.
* Others as defined in the protocol.
Skin Blood Flow Changes Using Laser Doppler Imager for Assessment of Pain and Analgesia in Newborn Infants

The purpose of this study is to assess whether an instrument, the Laser Doppler Imager, is able to measure the effect of pain related changes in skin blood flow in newborn infants. The study will also determine whether the use of sucrose (sugar water) when given by mouth has any effect on pain related skin blood flow changes.

During the last 25 years evidence that newborns can experience pain has been increasing. Painful procedures (injections, heel lances, and circumcisions) are part of normal routine newborn care. Studies have demonstrated that newborns have increased sensitivity to pain when compared with older children and adults. Pain assessment and management is an important component in the overall care of the newborn infant and safe, effective analgesics are needed.

Pain assessment is complicated by the infants' verbal and cognitive limitations. Heart rate, blood pressure and oxygen saturation are commonly monitored in the nursery in response to pain, yet these parameters are affected by handling, illness, medications, as well as by pain. Skin blood flow has been documented to increase in premature newborns undergoing painful procedures in the Newborn Intensive Care Nursery. In the present study, Laser Doppler Imager technology will be used to define changes in skin blood flow response to heel lance and oral sucrose administration in normal newborn infants.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent from parent or legal guardian.
* Term, newborn infant, between 1 and 7 days of age.
* Appropriate for gestational age (weight 5th through 95th percentile).

Exclusion Criteria:

* Small or large for gestational age (weight\<5th or \>95th percentile).
* Physical or biochemical abnormalities.
* History of maternal drug dependence.
* Apgar score \<7 at 5 minutes.
* Current use of analgesics.
Corneal Nerves After Treatment With Cenegermin

Neurotrophic keratopathy (NK) is a condition in which patients have fewer or complete absence of nerves in the cornea, characterized by the reduced or absent corneal sensation. The lack of nerves in the cornea also result in damages of the cornea and in severe situation the loss of the eye.

Cenegermin (trade name Oxervate) is a nerve growth factor eye drops designed to treat NK, and currently, it is the only FDA-approved medication for this purpose.

Even though cenegermin is effective in the majority of patients, there is a lack of understanding of how cenegermin works in the eye.

In this study, investigators aim to determine the structural and functional effects of cenegermin on the cornea, using non-invasive technologies including in vivo confocal microscopy on study participants with NK over the course of a year.

Cenegermin (OxervateTM) is a recombinant human form of nerve growth factor developed by Dompé Farmaceutici S.p.A. for patients who are diagnosed with corneal epithelial defects due to moderate to severe stages of NK.

Eligibility Criteria:
Inclusion Criteria

1. Patients ≥18 years of age; AND
2. Persistent corneal epitheliopathy that is refractory to treatments for ≥2 weeks; AND
3. Evidence of decreased corneal sensitivity, defined as ≤45mm on Cochet-Bonnet esthesiometer, within the area of the persistent corneal epitheliopathy; AND
4. Evidence of decreased corneal sensitivity, defined as above, in ≥1 corneal quadrant outside the persistent corneal epithelial defect.

Exclusion Criteria

1. Patients with severe neurotrophic keratopathy characterized by corneal stromal ulceration involving over 75% of the total central corneal thickness and impending perforation.
2. Patients who have used cenegermin eyedrops, autologous serum eyedrops, plasma-rich plasma eyedrops, or umbilical cord eyedrops for the treatment of neurotrophic keratopathy 8 weeks prior to study recruitment.
3. Corneal surgery (including keratoplasty or refractive surgical procedures) within three months before study enrollment.
4. Presence of concurrent bacterial or fungal infection.
A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder (MDD)

The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.

A multicenter, randomized, double-blind, parallel group, placebo-controlled, phase III efficacy and safety study of TC-5214 (S-mecamylamine) in flexible doses as an adjunct to an antidepressant in patients with major depressive disorder with an inadequate response to antidepressant therapy.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent before initiation of any study-related procedures.
* The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant.
* Out-patient status at enrollment and randomization.

Exclusion Criteria:

* Patients with a lifetime history of bipolar disorder, psychotic disorder or post-traumatic stress disorder.
* Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide.
* History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of the investigational product in this patient population
A Phase 3 Study to Evaluate the Efficacy of XW003 in Adults With Overweight or Obesity

The aim of the study is to evaluate the efficacy and safety of XW003 versus placebo in adults with overweight or obesity

In this Phase 3 study, eligible participants will be randomized into three cohorts in a 3:1:3:1:3:1 ratio to receive once-weekly subcutaneous XW003 (low, medium, or high dosage) or volume-matching placebo for 48 weeks, including a dose-escalation period.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18-75 years old, inclusive;
2. BMI between 24.0 to 28.0 kg/m2 with at least one comorbidity, including prediabetes, hypertension, hyperlipidemia, fatty liver , obstructive sleep apnea syndrome, etc.; or BMI ≥ 28 kg/m2 with or without comorbidities.
3. Weight change of no more than 5% (based on self-report), with diet and exercise alone, within 3 months before screening.
4. Willing and able to maintain stable diet and exercise during the study period.

Exclusion Criteria:

1. Obesity induced by endocrine diseases such as hypothyroidism, Cushing Syndrome, etc.
2. History of bariatric surgery (except liposuction \>1 year ago) or planned bariatric surgery during the study period.
3. Within 3 months before screening, history of using the following drugs or treatments:

   1. Any approved or unapproved weight-loss drugs or Chinese herbs or health products that affect body weight.
   2. Any hypoglycemic medication.
   3. Any medication that may cause significant weight gain, including systemic glucocorticoid treatment, tricyclic anti-depressants, anti-epileptic and antipsychotics.
   4. Any investigational drug, vaccine, or medical device.