cyrilzakka/clinical-trials huggingface dataset:
Study on Reflex Response During Temporary Stimulation and Inhibition of Chemoreceptors of Carotid Bodies - a Pilot Study

The isolated response of the carotid bodies to local stimulation with adenosine has not been researched in humans. There are single reports indicating that intravenous administration of adenosine causes hyperventilation through activating the carotid bodies.

Adenosine will be injected intraarterially during invasive treatment (percutaneous carotid artery stenting, CAS) or diagnostic (arteriography) procedures and their conduct will only slightly influence the standard scheme of the procedure.


Eligibility Criteria:
Inclusion Criteria:

* stenosis of one of the internal carotid arteries qualifying the patient to the procedure treatment (according to the ESC 2011 or American Heart Association (AHA) guidelines) or the necessity of the carotid artery arteriography, in order to verify the level of narrowing;
* in the case of procedure treatment, patient's declaration to be treated by the percutaneous method;
* stable clinical condition for at least 4 weeks prior to the inclusion in the study;
* over 18 years of age;
* ability to give and giving the informed consent to participate in the study.

Exclusion Criteria:

* bilateral significant carotid artery stenosis;
* complete closure or critical constriction of either of the carotid arteries;
* brain stroke or transient ischaemic attack (TIA) within 6 months prior to the inclusion in the study;
* unstable angina pectoris, coronary attack within 3 months prior to the inclusion in the study;
* coronary revascularisation or clinically significant infection within 1 month prior to the inclusion in the study;
* significant chronic neurological condition in medical history;
* dipyridamole or theophyline-based medications taken by the patient;
* bronchial asthma;
* GOLD 3 or 4 Chronic Obstructive Pulmonary Disease (COPD) in medical history;
* second or third degree atrioventricular block, sick sinus syndrome, or an additional evident track of atrioventricular conducting;
* advanced first degree atrioventricular block (PQ \> 240 ms)
* extension of the QTc interval \> 0.5 s;
* grade 3 (ESC) arterial hypertension;
* previously stated oversensitivity to adenosine;
* pregnancy;
* patients undergoing haemodialysis or peritoneal dialysis at inclusion in the study;
* undergone heart transplantation;
* any significant, in the investigator's assessment, aberrations detected in additional tests, increasing the risk related to performing procedures predicted by the protocol;
* lack of informed consent for the participation in the study;
* stage III (Fontaine) obliterative arteriosclerosis of the lower limb and/or Buerger's disease.
A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer

This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.

This is a Phase 1, open-label, uncontrolled, dose-escalation study with dose-expansion at doses determined to be tolerated. Patients who tolerate the drug and do not progress will be allowed to continue treatment. The study endpoints are safety and tolerability and pharmacokinetics. PSA values will also be collected to look for PSA response.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed adenocarcinoma of the prostate;
2. Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration);
3. Progressive disease after medical or surgical castration,

Exclusion Criteria:

1. Metastases in the brain or active epidural disease. (Note: patients with treated epidural disease are allowed);
A Study of Adebrelimab in Combination with Chemo with or Without Bevacizumab Neoadjuvant Therapy for Resectable NSCLC

This is a prospective, multicenter, randomized, uncontrolled Phase II study to assess the efficacy and safety of adebrelimab in combination with chemotherapy with or without bevacizumab for the treatment of resectable Stage II-IIIB (T3N2) NSQ-NSCLC and to explore biomarkers associated with efficacy.

Neoadjuvant therapy with experimental treatment followed by surgery.

Eligibility Criteria:
Inclusion Criteria:

* Resectable NSQ NSCLC
* Age 18-65 years
* male or female
* ECOG 0-1
* Subjects have not received surgery, chemotherapy, radiotherapy and biological treatment of treatment-naive non-squamous non-small cell lung cancer
* Subjects must have adequate pulmonary function for the intended pneumonectomy;

Exclusion Criteria:

* SCLC or SQ NSCLC
* previously used anti-PD1, anti-PDL1, anti-CTLA4 antibodies, etc.
* patients who have previously used anti-angiogenic drugs;
* allergic to any component of the study drug or chemotherapy drugs
* patients with any severe and or uncontrolled disease
Improving HIV Diagnosis, Linkage to Care, and Prevention Services With HIV Point-of-Care Nucleic Acid Tests

This project will develop, implement, and evaluate models for use of point-of-care nucleic acid testing (POC NAT) among HIV-negative persons seeking HIV testing, PEP, and PrEP and HIV-positive persons in community and clinical settings. Study aims #1 and #2 will evaluate the sensitivity and specificity of a qualitative POC NAT in persons not known to be HIV-positive and will determine the impact of its use on PrEP uptake and persistence among persons testing HIV-negative and on time to HIV continuum of care outcomes among persons testing HIV-positive. Aim #3 will implement a POC NAT-tailored behavioral intervention to evaluate impact on time to virologic suppression among PLWH receiving ART. Aim #4 will quantify the acceptability and feasibility of implementation of POC NAT in community and clinical settings and collect cost and related data for cost-effectiveness analyses. Finally, in Aim #5, a distinct but related study will compare the sensitivity, specificity, and agreement of multiple POC NATs over a range of HIV RNA levels.


Eligibility Criteria:
Inclusion Criteria:

* Persons who are HIV-positive and seeking care at Madison Clinic.
* 18 years of age or older
* Patient's provider is willing to deliver adherence intervention
* Patient is getting a laboratory RNA viral load test that day.
* Able to read and speak English

Exclusion Criteria:

* Patients of unknown HIV status
* Patients who have participated in the study before
Assessment of Electrolyte Values in the Intensive Care Unit:Comparison Between Arterial and Venous Blood Gas Analysis and Formal Laboratory Testing

The study hypothesis is that in critically ill patients there is significant differences between electrolyte levels measured using blood gas analysers and by laboratory techniques, and between levels measured on arterial and venous blood samples.

The sudy hypothesis is that in critically ill patients there is a significant difference between electrolyte levels measured using blood gas analysers and by laboratory techniques, and between levels measured on arterial and venous blood samples.

The study aim is determine the agreement between electrolyte levels measure by formal laboratory serum analysis and point-of-care blood gas analysis.

Also, to determine the agreement between electrolyte levels measured on simultaneous arterial and venous blood samples, using both serum and whole blood samples.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients 18 years or older admitted to the intensive care unit
2. Patients who have arterial and central venous access insitu for clinical management purposes.
3. Patients who consent to inclusion in the study, or if the patient is not competent, the next of kins' consent.

Exclusion Criteria:

Nil-
Median Effective Dose of Ciprofol-Assisted Sedation for Elderly Patients Undergoing Knee Arthroplasty

Regional anesthesia is a common clinical anesthesia method, and regional anesthesia-assisted sedation play a central role in promoting patient comfort and relieving anxiety. With increasing age, elderly people experience changes in pharmacokinetics and pharmacodynamics and increased drug sensitivity. Ciprofol has advantages in adverse events such as hypotension and respiratory depression. There are fewer studies on the recommended dosage of ciprofol-assisted sedation for intrathecal anesthesia in elderly patients. The aim of study is to identify the median effective dose(ED50) of ciprofol-assisted sedation in elderly patients undergoing spinal anesthesia

Select the patients who received knee arthroplasty in the Second Hospital of Shanxi Medical University. The patients received a loading dosage of 0.05mg/kg of ciprofol to begin sedation following the completion of intravertebral anesthesia, and the maintenance dose is calculated using the sequential method. Based on the relevant literature and pilot study, 0.2 mg·kg-1·h-1 is selected as initial test dose with a dose gradient of 0.02 mg·kg-1·h-1. The Modified Alertness Sedation Score (MOAA/S ) scores and the bispectral index (BIS) were recorded for patients before administration (T0), 5 min after administration (T1), 10 min after administration (T2), 20 min after administration (T3), 30 min after administration (T4), 45 min after administration (T5), and 60min after administration (T6). If the first patient had ≥ 4 time points with MOAA/A score ≤3 and BIS\<85 from T0-T6, the sedation was regarded as satisfactory, then the next patient 's dose of ciprofol was reduced by one level. On the contrary, if the patient's MOAA/S score and BIS at T0-T6 had less than 4 points of MOAA/S ≤3 points and BIS \<85, it was regarded as unsatisfactory sedation. The next patient's dose of ciprofol was increased by one level. After 8 crossovers, the trial was terminated. At the same time, the change of vital signs and adverse reactions before and after administration were recorded

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years
* ASA grade I\~III
* BMI 18\~30 kg/m2

Exclusion Criteria:

* Contraindications to intrathecal anesthesia
* Suffering from severe psychiatric or neurologic disorders or taking sedative drugs within the last 3 months
* Difficult airway or having respiratory diseases such as upper airway obstruction
* Severe cardiovascular system diseases
* Severe hepatic or renal dysfunction
* Allergy or contraindication to propofol and its drug-related components
* Patient Prefusal
Ridge Augmentation Using Patient Specific PEEK Sheets vs. Autogenous Bone Shell Technique.

Comparative study to assess the ability of the patient specific PEEK sheets in ridge augmentation with using mixed Autogenous/Xenogenic bone graft vs the Bone Shell Technique regarding the time, accuracy and donor site morbidity .

A- Intervention Group (Patient specific PEEK sheets)

* Preoperative Computed tomography will be done to the patients.
* Using special software, 3D models will be obtained and used to design the custom made PEEK sheets. The final STL (Standard Tessellation Language) files will be sent to the lab to be milled/printed.
* Autogenous bone graft will be taken from Chin/Retromolar graft and will be mixed with xenogenic bone graft in 1:1 ratio.
* After bone exposure, the ridge will be decorticated and the prefabricated PEEK sheets will be fixed with titanium screws and the space between the sheets and the ridge will be filled with the prepared bone graft.
* Wounds closure will be done.
* CT scan will be done postoperative.
* After 6 months another CT scan will be done for evaluation and comparison. Then the titanium screws will be removed and implants will be placed.

B- Control Group (Autogenous bone shell technique)

* Preoperative Computed tomography will be done to the patients
* Bone graft will be harvested from the chin/retromolar region and a cortico- cancellous bone block will be obtained then divided into two pieces used as the shells.
* The bone shells will be trimmed and adjusted to the recipient site and the remaining bone will be milled and mixed with Xenogenic bone graft with ratio 1:1
* The bone shells will be anchored in the host bone with titanium screws and the space between the shells and the alveolar bone will be filled by the bone graft mix.
* Wounds closure will be done.
* CT scan will be done.
* After 6 months another CT scan will be done for evaluation and comparison. Then the patient will go for micro screws removal along with implant placement.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with deficient alveolar bone in the anterior maxilla.
* Patient seeking fixed prosthesis at the anterior maxillary region.
* Highly motivated patients.
* Good oral hygiene.
* Patients willing for the surgical procedure and follow-up, with an informed consent.
* Bounded anterior maxilla cases.

Exclusion Criteria:

* Medically compromised patients.
* Uncooperative patients.
* Poor oral hygiene.
* Periodontal diseases.
* No history of any grafting procedure at the designated edentulous ridge.Criteria
* Patients with any diseases that compromise bone or soft tissue healing.
* Patients with no local pathosis that interfere with the bone healing.
Constipation and Gut Transit in DMD Patients

In this research study the investigators want to screen Duchenne Muscular Dystrophy (DMD) patients for signs and symptoms of constipation in patients over 18.

The investigators hypothesized:

* DMD patients have a high prevalence of constipation than in the general population.
* Prevalence of constipation will increase with age and with worsening functional status.

The following procedures will take place during the study.

Constipation Assessment:

* The patient will be asked to complete a questionnaire about any symptoms of constipation.
* A physician from the study team will perform an abdominal physical exam
* The patient will have routine x-rays that monitor for spine compression fractures. These films will also be used to assess stool content.

Clinical Information The following information will also be collected during the clinic visit ;

* Age at diagnosis and genetic mutation
* Age at loss of ambulation if applicable
* Medications
* Functional status

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of Duchenne Muscular Dystrophy (based on clinical presentation and verified by compatible muscle biopsy or known dystrophin gene mutation).
* Age greater than or equal to 18 years old

Exclusion Criteria:

* None
SeriACL™ Device (Gen IB) Trial for Anterior Cruciate Ligament (ACL) Repair

A multi-center single-arm clinical trial is being conducted to evaluate SeriACL device safety and performance during total anterior cruciate ligament (ACL) reconstruction.


Eligibility Criteria:
Major Inclusion Criteria:

* Complete rupture of the ACL
* Passive flexion \>= 120° and passive extension = contralateral knee
* MCL grade 2 or less
* Pre-injury Tegner score \>= 4
* Informed Consent

Major Exclusion Criteria:

* Prior ACL reconstruction.
* Severe pain, swelling, or redness
* Complete PCL tear
* Complex menisci tears
* Contralateral knee ligament injury
* OA \> Grade II
Preparing FIM-BCS - A Lifestyle Modification for African-American Breast Cancer Survivors

Hypertension and obesity are both major risk factors for cardiovascular disease (CVD), a leading cause of death for Black women in the United States. The investigators propose examining the feasibility and acceptability of the 12-week RN-CHeFRx (Real Nourishment and Cooking Healthy Food is Rx) intervention

- grocery delivery, cooking classes, and nutrition education - for Black women with hypertension and obesity to improve nutritious eating habits and blood pressure control.

The objective of this study is to conduct the RN-CHeFRx (Real Nourishment and Cooking Healthy Food is Rx) for 12 weeks among Black women who are obese and hypertensive living Chicago. We propose to 1) Pilot the RN-CHEFRx intervention and measures that will be used to assess blood pressure, BMI status, and sodium intake with 20 Black women diagnosed with hypertension and BMI ≥ 30. We will assess the efficacy of the evaluation tools to be used in a future clinical trial at three-time points (baseline, 12 weeks, and 6 months); and 2) Assess the feasibility and acceptability of the RN-CHeFRx intervention using interviews, surveys, and documentary analysis. Findings from this study will inform a larger efficacy trial of RN-CHeFRx to improve dietary behaviors and blood pressure control among Black women with hypertension and obesity

Eligibility Criteria:
Inclusion Criteria:

* self-identified as Black or of African descent
* female
* ≥ 18 years old
* baseline blood pressure ≥130/85 or diagnosed with hypertension and BMI ≥ 30

Exclusion Criteria:

* inability to cook in their homes
* cognitive deficits impeding the ability to participate or provide informed consent
* current treatment for cancer
* liver or renal disease
* pregnancy
* lack of English language proficiency
A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease

The main purpose of this study is to evaluate the efficacy and safety of retatrutide once weekly in participants with obesity and established cardiovascular disease (CVD). The study will last about 113 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) ≥35.0 kilogram/square meter (kg/m²).
* Have established cardiovascular (CV) disease with at least 1 of the following:

  * prior myocardial infarction
  * prior ischemic or hemorrhagic stroke, or
  * symptomatic peripheral arterial disease
* Have a history of at least 1 self-reported unsuccessful dietary effort to reduce body weight.

Exclusion Criteria:

* Have had acute myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina, or hospitalization due to congestive heart failure within 90 days prior to screening.
* Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
* Have a prior or planned surgical treatment of obesity.
* Have a change in body weight greater than 5 kg (11 pounds) within 90 days prior to screening.
* Have Type 1 diabetes.
* Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
* Have had pancreatitis.
"Impact of the Third Molars in Oral Health-related Quality of Life"

The aim of this study is to evaluate the impact of the third molars in oral health-related quality of life, before and after surgical removal using a validated and frequently used in international investigations instrument (OHIP-14).

This is a prospective study that evaluates the oral health-related quality of life through the application of the self-administered OHIP-14 before and after the surgical removal of third molars. The inclusion criteria were adults' patients older than 18 years, referred for oral surgery. Patients with chronic diseases and acute pericoronitis were excluded. The assessment was performed at three times: pre-surgical planning 1 day before surgery (T0), 10 days (T1) and 2 - 3 months after surgery (T2)

Eligibility Criteria:
Inclusion Criteria:

* Adults patients over 18 years old

Exclusion Criteria:

* Patients with chronic diseases and acute pericoronitis
Study of ASP7374, Cell-culture-derived Influenza Vaccine

The purpose of this study is to compare immunogenicity and safety of ASP7374 (cell-culture derived influenza vaccine) with those of approved egg-derived trivalent inactivated vaccine (TIV) in adults ≥20 and \<65 years.


Eligibility Criteria:
Inclusion Criteria:

* Healthy or medically stable, as judged on the basis of history and concurrent diseases.
* Subject understands procedure of the protocol and is willing to comply with the protocol.
* Written informed consent has been obtained.

Exclusion Criteria:

* Scheduled to receive another vaccine during the study.
* Received influenza HA vaccine within 180 days prior to screening.
* Received or scheduled to receive a live vaccine within 28 days prior to vaccination with the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination with the study vaccine.
* Diagnosis of immune deficit in the past, has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome.
* Received one of the following medications or treatment prior to vaccination with the study vaccine.
* Received one of the following medications or treatment prior to vaccination with the study vaccine: Interferon formulation, Drugs which affect the immune system, corticosteroids, G-CSF, M-CSF, Human immunoglobulin products, Blood products, Blood transfusion
* History of anaphylactic shock or an allergic reaction such as generalized eruption due to food (including chicken, poultry, foodstuffs derived from chicken, et al.) or drug (including vaccines) allergies, fever ≥39.0°C within 2 days after the previous vaccination (influenza vaccine and others)
* History of seizures, except for febrile seizures in childhood
Interactive Intention-Driven Upper-Limb Training Robotic System

The goal of this study is to determine robotic hand system is more effective than conventional physical and occupational therapy at promoting functional recovery of the affected arm in subjects after stroke.

This study will investigate the recovery in hand and upper limb functions when the physical training is assisted by an exoskeleton robotic hand system.

Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour.

During the training, you will be asked to do the hand open and hand grasp by Electromyography-driven robotic control strategy.

There will be evaluations on the upper limb motor functions before and after the 20-session of training and follow up session by clinical assessments on functional recovery.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour.

Exclusion Criteria:

* Excessive spasticity of the affected arm
* Participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.