cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of CNV2197944 Versus Placebo in Patients With Diabetic Peripheral Neuropathy

To investigate the effect of repeat oral dosing of CNV2197944 75 mg tid on the pain experienced in diabetic peripheral neuropathy (DPN) as measured by changes in PI-NRS after three weeks of treatment compared to the baseline period.

A 3 week randomised crossover study to investigate the effect of repeat oral dosing of CNV2197944 75 mg tid versus placebo for on the pain experienced in diabetic peripheral neuropathy (DPN). Each 3 week treatment period is seperated by a 2 week washout period. The primary outcome measure is the change from baseline in the PI-NRS after three weeks of treatment. Secondary outcome measures include pain responder rates, clinical and patient global impressions of pain, and the Neuropathic Pain Symptom Inventory.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 85 years of age inclusive, at the time of signing the informed consent
* Diabetes Mellitus (Type I or II)with HbA1c \<9%
* Evidence of symmetrical bilateral pain in lower limbs with evidence of decreased sensation or impaired reflexes and a Michigan Neuropathy Screening -Instrument score of \>3 on physical examination
* Patients with diabetic peripheral neuropathy (DPN) with pain at screening present for more than 6 months. The maximum duration of DPN will be no longer than 5 years

Exclusion Criteria:

* Patients having other severe pain, which may impair the self-assessment of the pain due to DPN
* Patients who have received nerve blocks for neuropathic pain within 4 weeks -Patients on other concomitant medications used to relieve the pain of DPN
* Patients with a documented failure to respond to a maximally tolerated dose regimen of gabapentin or pregabalin
Yttrium Y 90 Resin Microspheres Data Collection in Unresectable Liver Cancer: the RESIN Study

This research registry studies Yttrium Y 90 resin microspheres in collecting data from patients with liver cancer not capable of being removed by surgery (unresectable) for the radiation-emitting Selective Internal Radiation-Spheres (SIR-spheres) in non-resectable (RESIN) liver tumor registry. The information generated will help doctors better understand treatment patterns involving Y90 therapy, gain additional insights in the long-term outcomes for patients, as well as guide future research for using Y90 therapy, especially for those conditions where data is currently very limited or lacking.

PRIMARY OBJECTIVES:

I. The principal objective of the RESIN registry is to evaluate response to therapy using objective response criteria such as modified Response Evaluation Criteria in Solid Tumors (mRECIST) or European Association for Study of the Liver (EASL). The response criteria used will depend on tumor type treated and local policies as this is a registry and not a formal research study. Secondary criteria include overall survival, time to progression (TTP) and toxicity.

OUTLINE:

Patients receiving Yttrium Y90 resin microspheres treatment as part of their overall oncologic management are added in the RESIN registry database to collect and document information including: patient demographics (gender/age), previous oncologic treatments, details of Yttrium Y90 resin microspheres treatment, and to track outcomes and complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving SIR-Spheres therapy to the liver for the first time.
* Provision of written informed consent.
* Age 18 and older.

Exclusion Criteria:

1. Prior completion of Y90 therapy to the liver (SIR-Spheres, TheraSpheres, or any other liver-targeted therapy involving the use of radiation-emitting spheres).

   -Patients who have received Y90 treatment in the past and who are returning for another Y90 treatment are ineligible, even if new areas are being targeted.
2. Need for surrogate consent. Patients unable to consent on their own behalves are not eligible for this study.
A Study of JNJ-64304500 Following Subcutaneous Injection in Healthy Chinese Adult Participants

The purpose of this study is to assess the pharmacokinetic following single subcutaneous administration of Dose 1 or Dose 2 of JNJ-64304500 in healthy Chinese adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Male or female Chinese participants whose parents and maternal and paternal grandparents are of Chinese ethnicity
* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and until Day 113
* A male participant must agree not to donate sperm for the purpose of reproduction and must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and until Day 113
* A woman must have a negative highly sensitive serum beta-human chorionic gonadotropin (hCG) at screening and a negative urine pregnancy test on Day -1 and while enrolled in this study
* Nonsmoker or agree to smoke no more than 10 cigarettes or equivalent of e-cigarettes, or 2 cigars, or 2 pipes of tobacco per day throughout the study, if the inpatient unit allows. However, if smoking is not allowed in the inpatient unit, smokers will not be allowed to smoke while inpatient and cannot use nicotine replacement products during the inpatient period

Exclusion Criteria:

* History of any clinically significant medical illness or medical disorders the investigator considers should be exclude the participant, including (but not limited to) liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Had major illness or surgery, (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from illness or surgery, or has surgery planned during the time the participant is expected to participate in the study or until Day 113
* Plans to undergo non-major elective surgery within 4 weeks prior to study intervention administration through the end of the study
* Known or suspected allergies, hypersensitivity or intolerance to JNJ-64304500 or any biologic medication, or known allergies or clinically significant reactions to murine, chimeric, or human proteins, mAbs or antibody fragments, or to any components of the formulation of JNJ-64304500 and its excipients used in this study
Liver and Spleen Stiffness to Predict the Presence of Esaphageal Varices in Cirrhotic with Advanced HCC

Elasto-HCC is a prospective, uncontrolled, multicenter observational study involving several hepatology centers in Italy. Patients with liver cirrhosis and advanced hepatocellular carcinoma (HCC) who will need to undergo systemic therapy will be enrolled. Patients in the first phase will undergo measurement of liver and spleen stiffness and upper endoscopic evaluation and will subsequently be followed for 12 months

Hepatocellular carcinoma (HCC) and clinically significant portal hypertension (CSPH) frequently coexist, affecting cirrhotic individuals' prognosis. Recently it has been confirmed that in cirrhotic patients with favorable Baveno VI consensus (platelets\>150000/mm3 and liver stiffness measurement (LSM\<20 kPa) or combined model based on spleen stiffness, endoscopic screening for varices could be avoided. The Portal Hypertension (PH)-related complications in all patients should be avoided and well managed, especially if they have advanced HCC (aHCC) at diagnosis. However, unlike patients without HCC, endoscopy is recommended for those who undergo systemic therapy, even if compatible with favorable Baveno VI consensus . The reasons for this indication derive from the consideration that the presence of HCC could influence the measurement of LSM and platelet count.

To date, in cirrhotic patients without HCC, according to Baveno VII consensus and the last EASL guidelines for non-invasive tests (NITs), besides LSM, Spleen Stiffness Measurement (SSM) is now considered the most accurate NITs for assessing portal hypertension and predicting the presence of esophageal varices (EVs) and varices needing treatment (VNT).

To date, no studies have evaluated the accuracy of NITs (LSM/SSM) on patients with advanced HCC (aHCC) who should undergo systemic therapy.

The study aims to assess the performance of SSM to rule out VNT in patients with aHCC who undergo systemic therapy.

Each center will prospectively collect data according to an electronic e-CFR on REDCap (Research Electronic Data Capture) system, a web application designed to support data capture for research studies in a secure manner.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 yrs;
* Cirrhotic patients of any etiology with aHCC scheduled to receive any line of systemic treatment for HCC;
* Patients are willing and able to give informed consent.

Exclusion criteria:

* Presence of splenic, mesenteric, or portal vein thrombosis.
* Previous placement of TIPS at the time of informed consent.
Maintaining the Head Extension by an Assistant Decreases Dental Contact

The purpose of this study is to determine whether the head extension by an assistant decreases dental contact between laryngoscope blade and maxillary incisors during direct laryngoscopy


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing surgery that requires general anesthesia

Exclusion Criteria:

* disease or injury of cervical spine
* dentoalveolar injury
* history of difficult intubation
* anatomical anomaly of face or airway
Flow-controlled Ventilation (FCV) in Moderate Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19

Flow controlled ventilation (FCV) is a fairly new mode of mechanical ventilation, consisting of a constant inspiratory and expiratory flow. Inspiration is thus comparable to volume controlled ventilation (VCV). The actively controlled, constant flow during expiration is unique. FCV is known to minimize dissipated energy to the lung \[ref\] and is therefore supposed to aid in lung protective ventilation.

The VICAR study is designed as a prospective single cohort crossover trial. The intervention consists of a sequence of respiratory modes: baseline pressure controlled ventilation (PCV) during 5 minutes, followed by 30 minutes of FCV with an evone respirator (Ventinova Medical B.V., Eindhoven, The Netherlands) and eventually 30 minutes of VCV. Every participant will receive the intervention. Respiratory rate (RR), positive end-expiratory pressure (PEEP) and inspiratory fraction of oxygen (FiO2) will be held constant. According to the manufacturers guidelines, an I:E ratio of 1:1 will be pursued during FCV. During FCV, the respirator will be set with the same PIP as during baseline PCV. For VCV, the same tidal volume as during baseline PCV will be set.


Eligibility Criteria:
Inclusion Criteria:

* P/F-ratio: 100-200 (moderate ARDS)
* SpO2 88-94%
* PaO2 60-80 mmHg
* COVID-19 positive on a PCR test

Exclusion Criteria:

* BMI \> 40 kg/m²
* Prone ventilation
* Already invasively mechanically ventilated for more than 10 days
* Refusal to participate
Alzheimer's Disease and Related Dementias (ADRD) Prevalence in American Samoa

The goal of this study is to learn about ADRD prevalence within the Samoan population. Participants will be administered a series of cognitive assessments to determine cognitive status and a population-based prevalence of Mild Cognitive Impairment (MCI) and ADRD. Blood samples will also be collected from the participants for genetic and plasma biomarker analysis.

This study aims to do the following:

Test ADRD knowledge, health literacy, research readiness and determine ADRD resilience and vulnerability factors, and cognitive status in a probability sample of 981 Samoans age 50+ using culturally adapted instruments in our probability sample.

Conduct Gold Standard evaluations in our probability sample using the Uniform Data Set (UDSv3.0) from the National Institute on Aging (NIA) Alzheimer's Disease Research Center program to determine a population-based prevalence of MCI and ADRD for harmonization, data sharing, and comparison to other groups, and,

Cross-validate Gold Standard dementia evaluations with genetic (i.e., ApoE) and plasma Amyloid-Tau-Neuronal Injury/Neurodegeneration (ATN) framework biomarkers in our probability sample and compare to information available for other racial/ethnic groups.

Eligibility Criteria:
Inclusion Criteria:

* Age 50 or older
* Community dwelling
* Speaks English or Samoan
* Willing to contribute a biomarker specimen

Exclusion Criteria:

* Residing in Assistant Living or Skilled Nursing Facility
* Axis 1 Psychiatric diagnosis (e.g., Schizophrenia, Bipolar)
* Unstable medical condition (i.e., metastatic cancer) that could preclude completion of study visit
Children's Acute Surgical Abdomen Programme

To describe the type and quality of care being delivered to children (aged 1 - 16 years old) undergoing emergency abdominal surgery in the United Kingdom by measuring baseline compliance against evidence-based recommendations and identifying variations in care between individual hospitals.

The Children's Acute Surgical Abdomen Programme (CASAP) is a prospective national observational cohort study which aims to characterise the type and quality of care being delivered to children having emergency abdominal surgery.

The investigators aim to recruit every U.K. hospital undertaking this type of surgery in children, and capture information on 5000 patients over the study period.

The data collected will include information on patient risk factors, compliance with process quality indicators and the incidence and type of postoperative complications encountered. The data collected will be used to describe the current epidemiology of this patient group and to develop and internally validate a risk prediction tool for children undergoing emergency abdominal surgery. This tool be used to provide hospitals with their own risk-adjusted outcome measures and can subsequently be used to inform bedside decision-making. Patients will be followed up for 10 years through a data linkage process with National Health Service (NHS) Digital national databases.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 12 months and 16 years old
* Children undergoing unplanned abdominal surgery, where the preoperative diagnosis was considered to be related to a non-traumatic bowel (including appendix), hepatobiliary, and/or splenic pathology.

(Definitions - Unplanned is defined as non-elective (i.e. the patient presented requiring emergency or urgent intervention, either as a primary presentation or as a complication of previous surgery). Surgery is defined as a procedure undertaken by a surgeon in an operating theatre requiring the support of an anaesthetist. Any surgical approach (e.g. open, laparoscopic, robotic assisted etc) is acceptable.)

Exclusion Criteria:

* Patients / parents who do not provide consent.
* Children \<12 months old on day of surgery
* Elective procedures
* Operations where the preoperative indication for surgery was considered to be traumatic, urological or gynaecological in origin
* Organ transplants
* Insertion/removal of dialysis catheters
* Interventional radiology procedures
* Caesarean sections
* Herniotomies, if the procedure does not involve access to the intra-abdominal cavity.
A Pharmacokinetic-pharmacodynamic Dose Comparison Study of 8 mg/kg of Inhaled or Parenteral Gentamicin in 12 Mechanically Ventilated Critically Ill Patients Treated for Ventilator-associated Pneumonia

Ventilator associated pneumonia (VAP) remains in the intensive care unit the infection associated with the highest morbidity and mortality.

Respiratory infection with resistant organism are increasing in prevalence. Because of lack of alternatives, amino glycoside, old antibiotics family, can be used for several infection.

Aerosolized Amikacin or Tobramycin are used in mechanically ventilated patients for respiratory infections. Gentamicin,which is effective against numerous multi drug resistant Gram-negative organism and Gram-positive like Staphylococcus aureus, could be a great option for nebulisation.

The investigators assume that nebulisation of gentamicin allows to obtain a higher lung concentration while assuring a systematic toxicity much lesser than a parenteral administration.


Eligibility Criteria:
Inclusion Criteria:

* to be in critical care unit
* to be mechanically ventilated
* to have a ventilator-associated pneumonia requiring a treatment by gentamicin
* to be affiliated to a national insurance scheme
* to have given an informed consent (patient or close person)

Exclusion Criteria:

* to be obese (BMI \> 40 kg/m²)
* to have been treated by gentamicin for 7 days
* to be allergic to aminoglycoside
* to have a severe respiratory failure (PaO2 / FiO2 \< 150)
* to have a renal failure (Cl creat \< 60 ml/min/1.73m²)
* to be under reinforced protection measure
Optimization of Serum Phosphorus Level and Weaning From Mechanical Ventilation

The goal of this clinical trial is to test the impact of serum phosphorus level optimization on weaning from mechanical ventilation in adult ICU patients in Alexandria University Hospitals.

The main questions it aims to answer are:

* Does serum phosphorus level optimization affect the duration of mechanical ventilation?
* Is serum phosphorus level optimization associated with successful weaning from mechanical ventilation?

In critically ill patients, phosphorus supplementation is done using Sodium glycerophosphate pentahydrate solution.

Investigators will document patients' data in terms of independent variables and will randomly allocate the participants into one of the two study groups mentioned below.

* Control group, defined by maintaining serum phosphorus level at ≥ 2.5 and \< 3.5 mg/dL.
* Intervention group, defined by optimization of serum phosphorus P to ≥ 3.5 and ≤ 4.5 mg/dL (Average 4mg/dL).

Regression and comparative statistics will be used to determine whether the optimum serum phosphorus level offers a benefit in terms of the duration of mechanical ventilation and the success of weaning from mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Adult mechanically ventilated ICU patients.
* Age ≥ 18 years.

Exclusion Criteria:

* Age \<18 years
* Hypernatremia
* Permanent or prolonged mechanical ventilation
* Hyperphosphatemia which might occur in the following conditions:
* Chronic kidney disease and end stage renal disease
* Parathyroid disorders
* Cancer patients at risk of tumor lysis syndrome
* Immobility
* Body weight \< 50 Kg
Plaqenil Role in Prevention of Age Related Macular Degeneration

The investigators think that there is a connection between the use of plaquenil and the prevention of Age related macular degeneration (AMD). The investigators believe that the use of plaquenil makes bruch's membrane thicker, thereby preventing Chroidal Neovascularization (CNV) growth.

the study is done by comparing to groups RA patients who take plaquenil Vs. group of patients who do not take plaquenil. after measuring the retina thickness we compare the avg. thickness of both groups.

Eligibility Criteria:
Inclusion Criteria:

* all people who suffer from rheumatoid arthritis (RA) and use plaquenil

Exclusion Criteria:

* patients who did not complete follow-up
Blood Collection to Validated New Therapeutics Strategies Against Preeclampsia

The aim of the study is to setup a collection of maternal plasma and serum from patients with preeclampsia and normal pregnancy for in vitro validation of new therapeutics based on extra-corporal removal of sFlt-1

A collection of maternal plasma and serum from patients with preeclampsia (PE) and normal pregnancy (NP) :

* Between 20WG and 23WG+6D : 20 patients with PE and 30 patients with NP
* Between 24WG and 27WG+6D : 20 patients with PE and 30 patients with NP
* Between 28WG and 31WG+6D : 20 patients with PE and 30 patients with NP
* Between 32WG and 35WG+6D : 20 patients with PE and 30 patients with NP
* Between 36WG and 40WG+6D : 20 patients with PE and 30 patients with NP

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 50 years old
* Singleton pregnancies between 20 and 41 weeks of gestation
* Preeclampsia
* Normal pregnancy

Exclusion Criteria:

* Age\<18
* Infectious disease: HIV, HBV or HCV
* Multiple pregnancies
* Opposition of the patient
Martial Arts as Early Intervention for Teen Drug Abuse

This is a Stage 1A/1B behavioral therapy development project with the aim of developing and piloting an early intervention based upon traditional martial arts for adolescents who are in the early stages of substance use/misuse.

The primary aims of this study are:

1) To develop a manualized version of an existing, typical traditional martial arts program, modified to target a reduction in substance use and the associated behavioral and psychosocial problems for adolescents in the early stages of substance use or misuse, based on principles derived from empirically-based prevention programs. 2) To obtain preliminary pilot data on recruitment feasibility, validity of assessments, and estimates of the effect size of the intervention in reducing substance use and improving prosocial behavioral and psychosocial outcomes. 3) To refine and further develop the manualized program based on pilot data and utilizing feedback from the initial cohort of participants, traditional martial arts program instructors and substance abuse treatment experts. The goals of these revisions would be to maximize the impact of the program on substance use and behavioral outcomes, while retaining the core features of a traditional martial arts program to ensure the feasibility of implementing, sustaining, and disseminating such a program in existing community-based martial arts programs. 4) To develop procedures for training interventionists (i.e., martial arts instructors and research assistants) and for monitoring program adherence to ensure fidelity. 5) To conduct a small pilot study of the refined manualized program to enable us to estimate the effect size of the intervention and provide information for estimating power for a larger randomized controlled trial should the results of this intervention prove promising in terms of positive impact on the primary and secondary outcome measures: decreased drug use and improvement in psychosocial functioning and behavioral problems (including aggression).


Eligibility Criteria:
Inclusion Criteria:

Subjects must: 1) be 13 through 17 years old, 2) be of estimated average intelligence (IQ\>80), 3) have current or recent drug/alcohol use as evidenced by a history of substance use of at least 2 times in the 12 weeks prior to study inclusion, and 4) be medically healthy.

Exclusion Criteria:

Subjects will be excluded if they 1) meet criteria for substance dependence (other than for nicotine) based on consensus between the Composite International Diagnostic Interview- Substance Abuse Model (CIDI-SAM) and clinical interview, 2) have a history of or currently have psychosis (not explained by drug use), or bipolar disorder that is currently unstable, 3) are currently receiving psychotherapy or some form of behavioral therapy, 4) have a chronic medical illness or condition that would keep them from fully participating in physical activity, 5) have been started on a psychotropic medication in the 30 days prior to study inclusion, or 6) are pregnant.