cyrilzakka/clinical-trials huggingface dataset:
Assessment of a New Fluorescence Imaging Technique Using Biopsies From Prostate Resection

In this study, we aim to evaluate the feasibility of anti-PSMA labelling to detect post-operative prostatic tissues by two ex vivo fluorescence techniques. We will evaluate the feasibility and detection of anti-PSMA labelling by:

1. / the FEMTO-ST institute medical device,
2. / the confocal microscope that will be used to measure fluorescence spectra of biological samples.

For this protocol, 12 patients will be included.

Eligibility Criteria:
Inclusion Criteria:

* male patient over 18 years old
* patient with indication for radical prostatectomy
* patient with a rectal palpable nodule or targeted MRI positive biopsies or with at least 4 positive biopsies in a hemi-prostate.

  * patient affiliated to French social security system or equivalent
  * patient who have signed a non-opposition form

Exclusion Criteria:

* patient with contraindication to radical prostatectomy
* patient with remedial prostatectomy
* patient with normal preoperative MRI or with absence of tumoral area
* patient with history of hormonal therapy
* person deprived of freedom by judicial or administrative decision
* person under legal protection
* person hospitalized for psychiatric care.
Physiological and Perceptual Effects of Music on Resting Metabolic Rate (RMR)

The objective of the study is to determine whether music has any effect on resting metabolic rate (RMR), which is the amount of energy expended at rest. There is currently conflicting research on how music affects RMR. One problem with RMR testing is that participants often fall asleep during the test. There can be a 5-10% difference in the metabolic rate between rest and sleep. If no change in RMR is observed, playing music during an RMR test could be a potential strategy to prevent participants from falling asleep. Participants will undergo RMR measurements while listening to no music, relaxing classical music, and self-selected classical music.


Eligibility Criteria:
Exclusion Criteria:

* Any metabolic disorder, or significant cardiopulmonary disease
* Taking medications that are known to affect RMR
Study Evaluating Vabicaserin in Subjects With Schizophrenia

The primary purpose of this protocol is to establish the efficacy, safety, and tolerability of vabicaserin (SCA-136) using a once a day capsule in subjects with acute exacerbations of schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy, men and women, aged 18 to 65.
* Hospitalization because of an acute exacerbation of schizophrenia with a diagnosis of schizophrenia established greater than 1 year.
* Ability to remain hospitalized for the duration of the screening period and for 4 weeks of double-blind treatment.

Exclusion Criteria:

* Current Axis I primary psychiatric diagnosis other than schizophrenia (DSM-IV-TR criteria).
* Current diagnosis or history of substance abuse or dependence (DSM-IV-TR criteria), including alcohol (except for nicotine), within 3 months before baseline (day -1).
* Subjects taking high or chronic doses of benzodiazepine at the screening evaluation who, in the investigator's judgment, would be likely to have severe withdrawal symptoms upon discontinuation.
A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)

The main purpose of this study is to evaluate the efficacy and safety of ramucirumab in combination with erlotinib as compared to placebo in combination with erlotinib in previously untreated participants with stage IV non-small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Exon 19-Del and Exon 21 L858R). Safety and tolerability of ramucirumab in combination with erlotinib will be assessed in Part A before proceeding to Part B.

The purpose of Part C is to determine the efficacy and safety of ramucirumab in combination with gefitinib in previously untreated East Asian participants with EGFR mutation-positive metastatic NSCLC and of ramucirumab in combination with osimertinib in those participants whose disease progressed on ramucirumab and gefitinib and that have T790M - positive metastatic NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Cytologically or histologically confirmed diagnosis of Stage IV NSCLC as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer (AJCC 7th edition 2009).
* Eligible for first-line treatment with erlotinib based on documented evidence of tumor harboring an activating EGFR mutation \[exon 19 deletion or exon 21 (L858R) substitution mutation\].
* Mandatory provision of adequate archived stage IV NSCLC tissue samples or tissue samples other than stage IV NSCLC may be acceptable (optional for part C).
* At least one measurable lesion.
* Life expectancy of at least 3 months.

Exclusion Criteria:

* Known T790M EGFR mutation (not applicable for Part C Period 2).
* Known leptomeningeal carcinomatosis, uncontrolled/unstable spinal cord compression, or brain metastases.
* Serious illness or medical condition.
* Ongoing treatment with CYP3A4 inducers or strong inhibitors.
* Ongoing therapy with nonsteroidal anti-inflammatory drugs for more than 2 months.
* History of gross hemoptysis.
* Significant bleeding disorders.
* Radiologically documented evidence of major blood vessel invasion or encasement by cancer.
* Radiographic evidence of intratumor cavitation.
* History of gastrointestinal perforation within last 6 months.
* History of bowel obstruction, inflammatory enteropathy or extensive intestinal resection.
* History of any arterial thrombotic event within 6 months prior to enrollment.
* The participant has any known significant ophthalmologic abnormalities of the surface of the eye.
Pediatric Inpatient Firearm Safety Study

There is currently no available data regarding using the inpatient setting as an opportunity to talk to parents/guardians about firearm safety. The investigators will be doing a pre-/post-intervention study to investigate the effect of an intervention (a 5.5 minute Be SMART video and written materials developed by the organization Everytown for Gun Safety), on parental/legal guardian knowledge, attitudes and practices regarding firearm safety. While the American Academy of Pediatrics recommends the safest home for children is one without guns, the reality is that there are families with guns in the home. This non-political video focuses on ways to keep children safe from firearms.

The investigators will also investigate any additional effect of physician-delivered counseling on parental/guardian knowledge, attitudes and practices regarding gun safety as compared to receiving the information solely via video and written materials.

Participants will be randomized to 1 of 3 groups (intervention, intervention + MD discussion and control group). Outcomes will be assessed immediately post intervention and in a 30-day follow up phone call.

Eligibility:

All parents/guardians of inpatients admitted to the Children's Hospital at Montefiore.

Exclusion:

Parents/guardians whose children are in acute distress or in the Pediatric Intensive Care Unit.

Outcomes:

The primary outcome is the change in parent/legal guardian's behavior over the past 30 days with respect to how often they asked whether or not there are guns in the home when their child/children goes to play in another's person's home, as indicated by a Likert scale assignment of an ordinal value (1-5, 1= never, 2=rarely, 3=sometimes, 4=most of the time, 5=always).

Secondary outcomes will include:

* Change in the primary outcome (intention to ask noted above) between the intervention groups (Be SMARTalone vs. Be SMART + MD)
* Demographic factors associated with primary outcome
* Description of general knowledge on firearm safety of parents/legal guardians of patients in our community
* Description of attitudes about firearm safety of parents/legal guardians of patients in our community
* Description of general practices regarding firearm safety of parents/legal guardians of patients in our community
* Description of parents attitudes regarding physicians discussing firearm safety with them

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* parents/guardians whose child is hospitalized in the Pediatric Intensive Care Unit
* parents/guardians whose child is in acute distress
* parents/guardians who have previously been in the study
Pharmacists as Gate Keepers in Suicide Prevention: Needs of Pharmacists

This study aims to examine the opinions and needs of pharmacists and pharmaceutical technical assistants (FTA) concerning their role as gatekeepers in suicide prevention.

The primary objective is to map the experiences and needs of (public) pharmacists and FTA with regard to suicide prevention.

The secondary objective is to be able to develop more targeted tools, interventions or trainings based on the results of the needs assessment in order to facilitate the role of (public) pharmacists and FTA as gatekeepers in suicide prevention.


Eligibility Criteria:
Inclusion Criteria:

* Working as a (public) pharmacist or pharmaceutical technical assistant (FTA)
* 18 years or older
* Access to a computer, tablet or mobile phone with internet access
* Dutch-speaking

Exclusion Criteria:

* Hospital pharmacists or industrial pharmacists are not included in this study and thus constitute an exclusion criterion.
The GENPET Study - An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation.

The aim of the study is to determine if PET-CT imaging (using contrast recommended in clinical guidelines) is superior to combined bone scan and MRI/CT of the abdomen \& pelvis in detecting the increased incidence of metastasis (nodal/distant outside the pelvis) in men with prostatic carcinoma with mutations in any of the following germline DNA repair genes BRCA1, BRCA2, MSH2, MSH6, MLH1, PMS2, CHEK2, PALB2, ATM.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed pathogenic germline mutation in any of the following genes BRCA1, BRCA2, MSH2, MSH6, MLH1, PMS2, CHEK2, PALB2 or ATM.
* Over the age of 18
* Diagnosed with prostate cancer and at a time when staging imaging is clinically indicated; either:

  * At a new diagnosis
  * Biochemically progressing patients who were treated radically with surgery or radiotherapy (more than 6 months ago) and are currently not receiving hormonal treatment or chemotherapy
  * Patients on active surveillance with a PSA doubling time of 6 months or less

Exclusion Criteria:

* Diagnosis of other malignancy (excluding basal cell cancer/squamous cell cancer of the skin) within five years of diagnosis
* Known metastatic prostate cancer, both local and distant
* Patients who have received any oncological treatment within the last six months
* Patients on any investigational drug treatment
* Patients on steroids
* Known history of inflammatory/infective diseases (e.g. sarcoidosis, tuberculosis, inflammatory bowel disease)
* Contraindications to having an MRI using the standard MRI checklist (e.g. pacemakers, aneurysm clips, claustrophobia)
One Lung Ventilation: Double Lumen Tube

One lung ventilation (OLV) has become a standard procedure for the vast majority of interventions in pulmonary surgery. It is used in both techniques: thoracotomy and videothoracoscopy (VATS).

OLV can be provided by double lumen tube (DLT) with or without the hook. In our study the investigators want to find out if there is any advantage with one or another.

One lung ventilation (OLV) has become a standard procedure for the vast majority of interventions in pulmonary surgery. It is used in both techniques: thoracotomy and videothoracoscopy (VATS)(1).

OLV can be provided by double lumen tube (DLT) or bronchial blocker. There are advantages and disadvantages of both techniques, but DLT is more recommended because it allows total emptying of the operated lung. Air and secretion can be aspirated through the wide lumen of the tube during the surgery (2, 3).

There are many kinds of DLT which differ according to shape and material. Most commonly used are left sided DLT which are placed into left main bronchus and right or left lungs can be closed or emptied. Left sided tube have a hook which is placed on the carina to prevent displacement of the tube. There are also DLT without the hook which are more gentle and easier to place in the left main bronchus (4,5). After the insertion of the left tube without the hook, bronchoscopy is recommended to check the position of the tube (6,7,8,9).

Some severe complications (injury of the bronchial tree) after insertion of the hooked tube are found in the literature (10). The investigators have published such complication from our experience (11).

Each anesthesiologist decides individually which kind of DLT to use as there are no studies which have objectivised the advantage of either technique. There is only one study where they have compared both techniques but they have found no difference. That is why the investigators decided to study which technique is better so this can be included in our standard operative procedure.

Eligibility Criteria:
Inclusion Criteria:

* planned thoracotomy or VATS surgical technique
* with ASA (American Society of Anesthesiologist) physical status 1-3.

Exclusion Criteria:

* ASA\>3,
* severe heart illness (NYHA \>3),
* severe pulmonary obstructive disease (FEV1\<40%),
* neurologic disorders and
* patients with other respiratory or lung disease.
PVP Iodine Effect on Post Debridement Bacteraemia

The study investigates the effect of supra- and subgingival rinsing of 10% PVP prior to ultrasonic debridement in patients with periodontitis (as compared to rinsing with water) in terms of post treatment bacteraemia.

Study design: Randomized split-mouth (cross-over) study on 20 generally healthy subjects.

Process:

Test treatment:

* 1 min mouthwash with 10% PVP-iodine
* 1 min subgingival rinsing with 10% PVP-iodine
* 1 min ultrasonic debridement with 10% PVP-iodine as cooling liquid
* blood sampling from the V.mediana cupidi

Control:

* 1 min mouthwash with water
* 1 min subgingival rinsing with water
* 1 min ultrasonic debridement with water as cooling liquid
* blood sampling from the V.mediana cupidi

lysis, culturing and analysis of bacteria in the samples

Eligibility Criteria:
Inclusion Criteria:

* generally healthy, adult (≥ 18 years) patients with at least two periodontal pockets of ≥ 5 mm

Exclusion Criteria:

* Pregnancy
* Lactation
* Allergy on PVP-iodine
* anticoagulation (exception 100mg/d acetylsalicylic acid)
* high risc for endocarditis
* therapeutical radiation
* participation in other clinical studies
* cognitive impairment (patient unable to understand aim and conduction of the study
Study Evaluating Prevenar Immunogenicity in High Risk Children

To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition. To evaluate tolerability of Prevenar® in that population.

This study will require 24 months to be completed. Each child will participate for a period of time according to age of the 1st dose of vaccination: infants up to 6 months of age will be evaluated for 5 months; infants between 7 to 11 months will be evaluated for 3 months; children between 12 months up to 9 years of age will be evaluate for 2 months

Eligibility Criteria:
Inclusion Criteria:

* Children between 2 months to 9 years old.
* Children with HIV+; Sickle Cell disease; Neprotic symdrome; Chronic pulmonary disease
* No history of seizures
CGM in Patients With ED's

To determine the accuracy of continuous glucose monitoring (CGM) with point of care (POC) fingerstick glucose monitoring and venous blood glucose in patients with eating disorders, specifically anorexia nervosa, restricting subtype (AN-R); avoidant/restrictive food intake disorder (ARFID); and anorexia nervosa, binge/purge subtype (AN-BP).

It is the experience of the treatment team at ACUTE Center for Eating Disorders and Severe Malnutrition that POC fingerstick testing can be inaccurate in patients when POC fingerstick testing is compared to serum glucose values. However, this has not been formally studied.

This study seeks to define the accuracy of POC fingerstick testing and CGM as compared to blood serum glucose monitoring via phlebotomy. It also seeks to better understand the frequency of hypo- and hyperglycemia in this population using continuous glucose monitoring during the first 10 days of admission. Ideally, an accurate method of monitoring glucose values in this population beside phlebotomy draws needs to be established.

Blood will be drawn shortly after participants admission to the unit as part of usual care and will continue to be drawn daily as usual care for the next 5 days. Patient blood sugar will be checked daily using POC finger sticks until hypoglycemia resolves. If patient choose to participate in this study, the investigators will do additional POC testing on days 6 and 8 POC finger sticks will be done 30-minutes post breakfast/lunch/dinner. On the same day the patient agrees to be in this study, the patient will have a Dexcom CGM placed to the back of their arm, or on another area of the body depending on the recommendation from the manufacturer (DEXCOM). Patient will wear the CGM for the full 10 days that the study is being conducted.

Patient will also be asked to complete a simple log regarding the date and time the patient received post Breakfast/lunch/dinner POC tests on days 6 and 8. The patient may ask the PSCA Patient Safety Care Attendant (PSCA) to assist patient with this task.

Data received from the Dexcom device will automatically be uploaded to the Dexcom cloud. Only the research statistician will have access to these data. Staff from Dexcom do not have access to these data.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-65 and meet the DSM-V criteria for AN-R or AN-BP or ARFID
* Admission %IBW ≤ 75%

Exclusion Criteria:

* Diagnosed with an eating disorder other than AN-R or AN-BP or ARFID
* %IBW \> 75% on admission
* Inability to give informed consent to participate/lacks decisional capacity
* Unable to follow the study protocol
* Transferred to the unit on a mental health hold/short term certification
* Treatment team refusal of patient's participation
SAD Study of APR002 Investigating the Safety/Tolerability, Pharmacokinetics/Pharmacodynamics in Healthy Subjects

This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of APR002 in healthy subjects.

A Phase 1, Randomized, Blinded, Placebo-Controlled, First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APR002 Administered by Inhalation in Healthy Volunteers

Eligibility Criteria:
Inclusion Criteria:

* Healthy men or women aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
* Women can be of childbearing potential and must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 (screening) and be willing to continue on the chosen contraceptive method
* Male subjects should be willing to use a condom (with spermicide) to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child from the day of the investigational product administration until 3 months
* Have a body mass index (BMI) between 18 and 32 kg/m2 and weigh at least 45 kg.

Exclusion Criteria:

* History or presence of clinically significant medical (e.g., chronic obstructive pulmonary disease, asthma, COVID-19, etc.) or psychiatric condition or disease
* Abnormal vital signs, after minutes rest, defined as any of the following (SBP \> 140 mmHg, Diastolic blood pressure (DBP) \> 90 mmHg, Heart rate \< 40 or \> 99 beats per minute)
* Prolonged QTcF \> 450 ms or family history of long QT syndrome
EUS Guided Celiac Neurolysis

* Hypothesis:

  - Direct CGN enhances neurolytic drug delivery into celiac ganglia and increases the efficacy of neurolysis and subsequent pain control and survival in patients with pancreatic carcinoma.
* Rationale:

  * Standard CPN leads to inaccurate delivery of the injectate with rapid dispersal thereby only briefly remaining in contact with neural structures and limiting the degree of neurolysis. Poor targeting and delivery of a neurolytic agent may result in diminished neurolysis and decrease efficacy.


Eligibility Criteria:
Inclusion Criteria:

* 1. Unresectable pancreatic carcinoma (T4 or M1) or advanced T3 disease
* 2. Cytologic or histologic confirmation of pancreatic carcinoma
* 3. Abdominal pain (≥ 3 on NRS scale), ≥ 2 days/week, lasting ≥ 1 hour/ day, stable intensity for ≥ 7 days
* 4. EUS clinically indicated (for non-study purposes)

Exclusion Criteria:

* 1. Uncorrectable coagulopathy: (INR) \> 1.5 and/or platelets \< 50,000
* 2. Abdominal surgery within 1 month
* 3. Prior celiac plexus or ganglia neurolysis.
* 4. Initiation or modification in chemotherapy or radiotherapy within prior 7 days.
* 5. Direct tumor infiltration of the celiac trunk and/or celiac ganglia.
To Observe Ability of Fundamental Movement Skills in School Children of Age 5 to 10-year-old in Udupi District

Fundamental movement skill is the precursor for physical activity in later life. Proficiency of Fundamental Movement Skills in Indian School Children is unknown. This observational trial shall tell us how proficient are our Udupi District Children.

After IRC and IEC approval and approval from district educational officers, proper assent and consent will be given to the principal of the respective school.

1-week prior to the study, parents will be explained about the study during parent meeting and even school leaving and opening times, a parent who visits the school to drop their children will be addressed.

Children of age above 7 yr. will be explained the class about the study.

Inform sheets will be distributed after conveying the information.

Only the children who get an informed sheet signed will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* All children in the age group 5 to 10 year old

Exclusion Criteria:

* Cerebral palsy
* Attention deficit/hyperactivity disorder
* Autism
Study of ORL-1M (D-mannose) in Patients With CDG-Ib

Study of ORL-1M in Patients With CDG-Ib


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CGD-1b.
* Less than 18 years old.

Exclusion Criteria:

* Diagnosis of any other disease that is not a manifestation of CGD-1b.
Brugada Syndrome and Artificial Intelligence Applications to Diagnosis

Aim of the project is the development of an integrated platform, based on machine learning and omic techniques, able to support physicians in as much as possible accurate diagnosis of Type 1 Brugada Syndrome (BrS).

The aim of BrAID project is to integrate classic clinical guidelines for Brugada Syndrome 1 diagnosis evaluation with innovative Information and Communication Technologies and omic approaches, generating new diagnostic strategies in cardiovascular precision medicine of this disease.

Eligibility Criteria:
Inclusion Criteria:

* Brugada patients: patients with Brugada Syndrome 1 spontaneous or induced by the ajmaline test; patients with non-diagnostic electrocardiographic pattern for Brugada Syndrome 1 or negative in the presence of high clinical suspicion (family history for Brugada Syndrome, patients who survived cardiac arrest without organic heart disease)
* Control patients: patients with frequent premature ventricular complex and normal left and right ventricular function; patients with suspected Brugada Syndrome 1 not confirmed by ajmaline test

Exclusion Criteria:

* organic heart disease or diseases interfering with protocol completion
* lack of signed informed consent
* pregnancy
* acute coronary artery disease, heart failure in the previous 3 months
* severe renal or liver failure