cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Gastric Tube Guide to Place Orogastric Tubes

A randomized controlled prospective study of orogastric tube placement with the Gastric Tube Guide vs conventional placement.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 Years
* No concurrent participation in another study
* Capacity to consent
* Present written informed consent of the research participant
* Elective surgery in general anesthesia
* Required orogastric intubation

Exclusion Criteria:

* Existing pregnancy
* Emergency patients
* Preexisting pathological findings in the mouth, pharynx or esophagus
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight

This is a study of tirzepatide in participants with type 2 diabetes who have obesity or are overweight. The main purpose is to learn more about how tirzepatide affects body weight. The study will last 79 weeks (22 visits).


Eligibility Criteria:
Inclusion Criteria:

* Have Type 2 Diabetes (T2DM) with HbA1c ≥7% to ≤10% at screening, on stable therapy for the last 3 months prior to screening. T2DM may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or glucagon like peptide-1 receptor agonists (GLP-1 RAs)
* Have a BMI of ≥27 kg/m²
* Are overweight or have obesity
* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight
* Are at least 18 years of age and age of majority per local laws and regulations

Exclusion Criteria:

* Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except T2DM
* Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values \>270 mg/dL(on 2 nonconsecutive days) prior to Visit 3
* Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment
* Have self-reported change in body weight \>5kg within 3 months prior to screening
* Have had a history of chronic or acute pancreatitis
* Change in body weight greater than 5 kg within 3 months prior to starting study
* Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
* Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
* History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
* Any lifetime history of a suicide attempt
ESCORT-HU Extension: European Sickle Cell Disease Cohort - Hydroxyurea - Extension Study

As safety information pertaining to the long-term use of HU remains incomplete in spite of the first safety study (ESCORT-HU), an extension of the latter is proposed. ESCORT-HU Extension study aims at evaluating the long-term safety of Siklos® focusing on some questions regarding its safety when used in current practice in adults and paediatric patients treated with Siklos® and followed for up to 5 years. The study will focus on the following concerns : occurrence and incidence of malignancies, leg ulcers, male fertility impairment and serious unexpected AEs causally related to Siklos®.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with symptomatic SCD,
* ≥ 2 years old,
* Treated with Siklos®,
* Having been informed of the study by the investigator and consenting to participate, or whose parents or legal guardians are consenting for their child to participate.

To allow risk evaluation, participants must belong at least to one of the subpopulations defined below:

* Participants previously enrolled in ESCORT-HU who agree to participate in ESCORT-HU Extension study,
* New participants with any of the following criteria:

  * history of HU treatment for more than 5 years or
  * prepubescent over 10 years of age for girls and 13 years of age for boys at enrolment, or
  * with history of leg ulcer, or
  * pregnant women without interruption of Siklos® 3 months before the beginning of the pregnancy or,
  * males treated with Siklos® whose partner is pregnant and without discontinuation of Siklos® 3 months before the beginning of the pregnancy.
COmparing CeNters ThRombectomy Aspiration STentretriever

Our aims is to evaluate the equality in efficacy and safety between direct aspiration technique and stent retriever thrombectomy procedure in anterior circulation strokes in a multicenter, prospective study.


Eligibility Criteria:
Inclusion Criteria:

* Subject experiencing an acute ischemic stroke in which imaging demonstrates a vascular occlusion located in the distal internal carotid artery (ICA) through the distal middle cerebral artery (MCA).
* Subjects in which the aspiration technique is used for at least the first two thrombectomy passes per occluded vessel.
* Subjects older than 18 yo.
* Subjects with a prestroke modified Rankin scale of 0-2 and presenting with an NIHSS of 2-30.
* Subjects that the operator feels may be treated with endovascular therapy
* Subjects in which computed tomography (CT)/Magnetic Resonance Imaging (MRI) demonstrates an infarct size of less than 70cc on MRI or Alberta Stroke Program Early CT (ASPECTS) score overall of 6 or better.
* Subjects in which groin puncture can be obtained within 6 hours of symptom onset (with or without Total Plasminogen Activator administration). In those Patients of more than 8 hours or awake stroke or of unknown onset should be individualized the treatment and must exist area of penumbra in CT perfusion
* Subjects who have consented in accordance with local Institutional Review Board requirements

Exclusion Criteria:

* Absence of large vessel occlusion on neuroimaging.
* Platelet count \< 100 x 10³ cells/mm³ or known platelet dysfunction.
* Contraindication to CT and/or MRI (i.e., due to contrast allergy or prior implant that precludes MRI imaging).
* Previously documented contrast allergy that is not amenable to medical treatment.
* Women who are pregnant or breastfeeding at time of intervention.
* Evidence of brain hemorrhage on CT and/or MRI at presenting hospital.
The Effect of Dietary Nitrate Supplementation on Ability of Individuals With Type 2 Diabetes to Perform Exercise

The investigators are conducting a research study to see if increasing the amount of nitrate (a substance found in large quantities in certain vegetables) in the diet can increase the ability of individuals with Type 2 diabetes (T2D) to perform exercise. Some people with T2D find exercise more uncomfortable than individuals who do not have T2D. This may be explained by the experimental studies showing that T2D can result in reductions in the supply of oxygen to the muscles. Studies have also shown that for a given level of activity, individuals with T2D will be much closer to their maximum exercise capacity than healthy individuals. Dietary nitrate may have two important beneficial effects in individuals with T2D: 1) The effects of dietary nitrate on the responses to exercise may have a significant impact on the ability of individuals with Type 2 diabetes to perform daily tasks and exercise more comfortably and 2) experimental studies suggest that increased nitrate consumption has been shown to reduce the amount of oxygen required for a given level of exercise.

The investigators will recruit 60 individuals with T2D. These people will take part in a randomised crossover design study where they will be asked to drink normal beetroot juice (rich in nitrate) and nitrate depleted beetroot juice, prior to performing two different walking exercise tasks (a six minute walk and repeated, low intensity treadmill walking). This study aims to determine if dietary nitrate supplementation reduces the amount of oxygen required for a given level of exercise in individuals with T2D. To test brain function individuals will be asked to perform a standard computerised decision making task following consumption of the nitrate rich and nitrate depleted juices.


Eligibility Criteria:
Inclusion Criteria:

* patients with T2D (as defined by WHO) of at least 5 years duration between the ages of 35-75 will be invited.

Exclusion Criteria:

* patients with significant renal impairment (eGFR\<30)
* uncontrolled hypertension
* BMI\<25 or \>35
* are taking regular organic nitrates, nicorandil, or thiazolidinidiones, or any medication which may interfere with data interpretation or safety
* who have had a myocardial infarction or cerebro-vascular event
* who smoke, or any other serious medical condition which would interfere with data interpretation or safety will be excluded from participation.
Oral Contraceptive Pills Compared to Vaginal Rings

The purpose of this study is to determine whether teens and young women would prefer the Nuvaring to oral contraceptive pills after having tried both methods.

Sexually active young women (n=130), aged 15-21 years, were randomly assigned to use either the vaginal ring or oral contraceptive pills for an initial study interval of three 28-day cycles, followed by three cycles of the alternate method. Participants completed surveys about method use, acceptability and side effects at baseline, after three cycles, and after six cycles, as well as in a follow up telephone interview one month after study completion.

Eligibility Criteria:
Inclusion Criteria:

* Sexually active young women (n=130), English or Spanish speaking, aged 15-21 years, able and willing to try oral contraceptives and vaginal rings for 6 months

Exclusion Criteria:

* Not able or willing to use hormonal contraceptives, moving out of the area, pregnant or intending to become pregnant during the study time frame, not sexually active
State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With Deep Brain Stimulation (DBS)

The purpose of this study is to use an investigational device to record brain activity for 12-24 months following surgical implantation of deep brain stimulation (DBS) systems. The goal of the study is better understanding of brain activity in Parkinson's disease and how they relate to DBS and pharmacological management, not to bring new devices to market.

Experimental: chronic brain recording This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of idiopathic Parkinson's Disease (PD).
2. Age 45-75 years
3. UPDRS III motor score (off PD medications) ≥ 25
4. Demonstrated good response (≥ 30%) to Sinemet or dopamine agonist medications as assessed by total UPDRS III score (off and on meds)
5. Approved for unilateral subthalamic nucleus (STN)- or globus pallidus internus (GPi)-DBS surgery to treat their clinical motor signs and plan to undergo the standard of care procedure within the next four months
6. Cleared to be scanned in a 7 tesla magnet
7. Written documentation of willingness to participate in the study per protocol as evidenced by the informed consent process

Exclusion Criteria:

1. Clinically significant medical disease that would increase the risk of developing pre- or post-operative complications (e.g., significant cardiac or pulmonary disease)
2. Evidence of secondary or atypical parkinsonism
3. Dementia as evidenced by impairment in two neuropsychological domains and impaired or borderline neuropsychological function in one additional domain.
4. Unable to undergo magnetic resonance imaging (e.g., due to incompatible implanted pacemaker)
5. Previous pallidotomy or DBS surgery
6. Women who are currently pregnant or are breast feeding
7. MRI showing cortical atrophy out of proportion to age and/or MRI showing focal brain lesions that could indicate a non-idiopathic movement disorder
8. Any prior intracranial surgery
9. Subjects with depression defined according to Diagnostic and Statistical Manual V criteria and a scored on a validated depression assessment scale
10. History of seizures
11. Immunocompromised
12. Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) to treat a chronic condition
13. Has an implanted electronic device such as a neurostimulator, cardiac pacemaker or medication pump.
Open Abdomen Study Comparing ABThera™ Open Abdomen Negative Pressure Therapy System and Barker's Vacuum Packing Technique

This study is being done to gather data that will be used to compare two different TAC (Temporary Abdominal Closure) methods that your doctor may use. The two TAC methods being compared are the Barker's vacuum packing technique or BVPT and the Open Abdomen Negative Pressure Therapy System (ABThera) developed by the sponsor of this research (KCI, San Antonio, TX). The BVPT is made up of supplies that are stocked in most surgery rooms. The ABThera dressing is available commercially. Neither method will be supplied to the doctor (Principal Investigator), so that in no way would the subject's standard of care be different from what they would get if the study was not being done.

This study is observational and only collects data about how the subject progresses after surgery TAC is used. When a study is observational it means that the subject's standard medical care will not be altered in any way, simply watched. The doctor will not change treatment of your open abdomen.

This study is being done to gather data that will be used to compare two different TAC (Temporary Abdominal Closure) methods. The two TAC methods being compared are the Barker's vacuum packing technique or BVPT and the Open Abdomen Negative Pressure Therapy System (ABThera) developed by the sponsor of this research (KCI, San Antonio, TX). The BVPT is made up of supplies that are stocked in most surgery rooms. The ABThera dressing is available commercially. Neither method will be supplied to the doctor (Principal Investigator), so that in no way would the subject's standard of care be different from what they would get if the study was not being done.

This study is observational and only collects data about how the subject progresses after surgery TAC is used. When a study is observational it means that the subject's standard medical care will not be altered in any way, simply watched. The doctor will not change treatment of your open abdomen.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects 18-75 years of age
2. OA Subjects treated with only one of the following TACs at initial placement (defined as the time of the first application of a TAC method):

   1. ABThera
   2. BVPT

Exclusion Criteria:

1. Pregnant females
2. Active, uncontrolled hemorrhage at the time of TAC placement
3. Diagnosis of pre-existing bleeding disorder
4. Known allergy or hypersensitivity to polyvinyl, polyurethane, acrylic, or acrylic adhesive
5. Subjects with fistulas
6. Subjects who have been enrolled in this study previously
7. Documented history of Child-Pugh Turcot Liver Dysfunction - Class C (10-15 points) at the time of enrollment
8. Subjects with body mass index (BMI) \> 40 as estimated at the time of Emergency Department (ED) or OR admission
9. Known New York Heart Association Functional Classification - Class IV at the time of enrollment
Fruit and Vegetable Rx (FVRx) + Home Plate

This is a research study to test if fruit and vegetable prescription vouchers (FVRx) and a cooking skills program (Home Plate) can improve dietary quality, food security (access to a sufficient quantity of affordable, nutritious food), feelings about the home and community food environments, and caregiver mental health.

The purpose of this research study is to determine the effect of produce prescriptions (vouchers that can be redeemed for produce at participating locations, "FVRx") and a cooking skills program (Home Plate) on dietary quality, food security, perceptions of the food environment, and mental health. Investigators also aim to determine the feasibility and acceptability of the programs.

Eligibility Criteria:
Inclusion Criteria

1. At least one child in the household is age 2 to 5 years.
2. Household is food insecure and/or low-income with an age-eligible, overweight or obese child.

   * If a child meets the above criteria, any sibling age 2-5 is also eligible.

Exclusion Criteria

1. Caregiver or eligible children have a medical condition that significantly affects diet or eating habits.
Efficacy of an Arabic Articulatory Error Remediation Software Program in Patients With Velopharyngeal Valve Dysfunction:

To develop a remediation software program that is specific for correcting speech errors in patients with velopharyngeal dysfunction in the Arabic language and test its efficacy, on one group comparing pre and post results

The study was carried on 40 patients having articulation errors in cases of velopharyngeal valve dysfunction attending the unit of phoniatrics, otorhinolaryngology department, Alexandria University.

The patients met the specified inclusion and exclusion criteria. The patient underwent pre intervention evaluation and 3 parameters were chosen to compare efficacy of the program before and after therapy.

these include auditory perceptual assessment of speech, nasometer test and articulation test.

The patient underwent the remediation software program as individual sessions. then after finishing the therapy, the patients underwent post therapeutic evaluation with the 3 specified criteria

Statistical analysis Was carried out using SPSS statistics software version 23. Quantitative data were tested for normality using the Kolmogorov-Smirnov test. The variables which were normally distributed were described by Mean± SD. The variables which were not normally distributed, were described by median (Min-Max). Qualitative data were expressed by numbers and percentages. The results were calculated at a level of significance of 5% or less.

Eligibility Criteria:
Inclusion Criteria:

* clinically presented by articulation errors due to velopharyngeal dysfunction
* Age of 5 years and above with
* must have normal hearing and vision.

Exclusion Criteria:

* Unrepaired cleft palate.
* Large palatal fistula.
* Brain damage and intellectual disability.
A Study of Efficacy and Safety of "On-demand" Maintenance Therapy With Rabeprazole in Patients With Non-erosive Reflux Disease (NERD)

The purpose of this study is to assess the efficacy and safety of long-term, "on-demand" maintenance therapy with rabeprazole in patients with non-erosive reflux disease (NERD).

More than half of patients with typical gastroesophageal reflux symptoms such as heartburn are considered to have non-erosive reflux disease (NERD), which is characterized by a lack of clinically defined damage to the esophagus. One approach to maintain control of these symptoms is to have medication available "on-demand." This is a double-blind, placebo-controlled study of the effectiveness of "on-demand" rabeprazole in the long-term maintenance of heartburn control in NERD patients, for whom heartburn was resolved with short-term, daily rabeprazole therapy. The study has two phases: an acute phase (4 weeks) during which patients receive rabeprazole medication daily, and an "on-demand" phase (6 months) during which patients take medication (rabeprazole or placebo) as needed. Only patients who have complete resolution of heartburn at the end of the acute phase are eligible to continue in the "on-demand" phase. Efficacy assessments include the proportion of patients discontinuing treatment in the "on-demand" phase because of insufficient heartburn control, and the severity of heartburn and patient satisfaction determined at the beginning and end of "on-demand" phase. Safety assessments include incidence of adverse events throughout the study, physical examination at study initiation, and vital signs at the beginning and the end of the study. The study hypothesis is that "on-demand" therapy with rabeprazole is superior to placebo in maintaining heartburn control and is well tolerated by the patients with NERD. Rabeprazole tablet (10 milligrams\[mg\]) once daily in the morning for 4 weeks. Rabeprazole tablets (10mg) once daily on an "on-demand" basis for the following 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Minimum of 12 months history of heartburn as the predominant symptom with at least 2 symptomatic episodes
* Negative endoscopy (no erosive lesions according to the Modified Savary-Miller scale) within 7 days prior to acute treatment
* at least 3 days with moderate to very severe heartburn within one week prior to acute treatment

Exclusion Criteria:

* No known gastro-duodenal ulcer
* no infections, inflammations, or obstruction of the small or large intestine
* no history of gastrointestinal cancer, or prior surgery of the stomach or intestine
* no stomach or abdominal pain or discomfort as the predominant symptom or that requires treatment
* no history of erosive reflux causing inflammation of the esophagus
* no stricture of the esophagus, stomach, or any condition that causes difficulty in swallowing
* no history of non-erosive reflux disease (NERD) that is or was refractory to an adequate treatment course (1 month) with proton pump inhibitors
* no females who are pregnant or those lacking adequate contraception
A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors

This study was an open-label phase I study to evaluate the safety, tolerability, PK profile and potential efficacy of SSGJ-705 as a single agent in patients with advanced malignancies.

This study includes 4 Parts: Part 1 (dose escalation and dose extension for QW administration), Part 2 (dose escalation and dose extension for Q2W administration), Part 3 (dose escalation and dose extension for Q3W administration), and Part 4 (indication extension, such as HER2 expression, PD-L1 high expression, driver gene negative newly treated advanced NSCLC, or other tumors).

Eligibility Criteria:
Inclusion Criteria:

1. Males and/or females over age 18
2. Histologically and/or cytologically documented local advanced or recurrent or metastatic malignancies
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Expected survival \>3 months.
5. Signed informed consent form.
6. Must have adequate organ function.

Exclusion Criteria:

1. Any remaining AEs \> grade 1 from prior anti-tumor treatment as per CTCAE v5. 0, with exception of hair loss, fatigue, and grade 2 peripheral neurotoxicity.
2. Pregnant or nursing women or women/men who are ready to give birth
3. Symptomatic central nervous system metastasis.
4. Allergy to other antibody drugs or any excipients in the study drugs.
5. Severe dyspnea at rest due to complications of advanced malignant tumors, or needing supplemental oxygen therapy.
6. Participated in any clinical study of medical devices or drugs within 1 month prior to screening (excluding non-intervention clinical studies or follow-up period of intervention clinical studies) .

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.