cyrilzakka/clinical-trials huggingface dataset:
Safety and Performance Study of the Moderato System

The purpose of the study is to evaluate the safety and performance of the Moderato System by implanting the Moderato pacemaker in patients who require a dual chamber pacemaker, and who also have hypertension, in order to reduce their blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years of age
* Subject is indicated for implantation or replacement of a dual chamber permanent pacemaker where no lead extraction is necessary.
* Subject has stable regimen of 2 or more maximally tolerated anti-hypertension medications, which is anticipated to be able to be maintained without changes for 3 months.
* Subject has office systolic blood pressure measurements \> 140 mmHg on two separate days within a one week period prior to enrollment, and the average of these two measurements is ≥150 mmHg

Exclusion Criteria:

* Subject has known secondary cause of HTN
* Subject has a history of atrial fibrillation
* Subject has ejection fraction \<50%
* Subject has symptoms of heart failure of NYHA Class II or more
* Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm
* Subject is on dialysis
* Subject has estimated Glomerular Filtration Rate (GFR) \<30 ml/min/1.73m2
* Subject has prior neurological events (stroke or TIA) or carotid artery disease
* Subject has known autonomic dysfunction
* Subject has a history of clinically significant tachyarrhythmia
* Subject has had previous active device-based treatment for hypertension
* Subject has an existing implant, other than a pacemaker that needs replacing
* Subject with average Systolic BP \>190 mmHg
The Effect of When Medication is Taken on Nutritional Status in Hospitalized Patients Older Than 65 Years

Polypathology in elderly subjects requires polypharmacy but even though the efficacy of a medication and digestive tolerance are ensured, the medication can be taken a long time from meals to reduce its side-effects. Despite numerous studies that have investigated links between medication and malnutrition, none have assessed the influence of the time the drug is taken on the evolution of the nutritional status of elderly hospitalized persons. So as to identify the best nutritional criterion in hospitalized persons, a retrospective pilot study will be conducted in about thirty patients. Their medication will be recorded and their nutritional status will be evaluated using the Geriatric Nutritional Risk Index (GNRI), albumin, prealbumin levels, weight and the Mini Nutritional Assessment (MNA) short form.

This preliminary study will allow us to choose the best nutritional criterion to compare the impact of two strategies for taking medication (post prandial versus pre-prandial) on improving the nutritional status of malnourished elderly hospitalized patients taking multiple drugs.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 65 years or more.
* patients with a stable or controlled acute disease hospitalized in a geriatric follow-up care unit.
* patients whose life expectancy is greater than 30 days.
* patients able to eat food normally.
* patients able to swallow their medication.
* patients with at least 3 drugs to be taken orally per day, not including oral nutritional supplements.

Exclusion Criteria:

* patients at the end of life.
* patients whose drugs must be taken before meals like Non-steroid anti-inflammatory drugs (NSAIDs), glinides, oral antidiabetic agents (OAD).
* patients with parenteral and/or enteral nutrition in the period preceding admission to the geriatric unit.
* patients with indications for parental and/or enteral nutrition.
QTX3046 in Patients with KRAS G12D Mutations

Phase 1 study to determine the safety and tolerability of QTX3046 as a single agent or in combination with cetuximab.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D mutations identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic.
* Part 1: Advanced solid tumors with at least one prior systemic therapy.
* Evaluable and measurable disease per RECIST v1.1.
* Part 2 and 3: Measurable disease per RECIST v1.1

Exclusion Criteria:

* Active brain metastasis or carcinomatous meningitis
* Significant cardiovascular disease
* Active infection requiring intravenous (IV) antibiotics
* Prior treatment with a KRAS inhibitor

Other protocol-defined Inclusion/Exclusion Criteria may apply
Multi-session, Personalized Cognitive Bias Modification for Thought-Action-Fusion

Thought-Action-Fusion (TAF) is a cognitive bias that posits (1) having unwanted thoughts is morally equivalent to acting upon the thoughts (TAF-Moral; e.g., "Thinking about harming a child is as immoral as actually harming a child") and (2) having unwanted thoughts will increase the likelihood of the thoughts happening in real life (TAF-Likelihood; e.g., "My mother will get into a car accident, because I thought about it"). Given its central role in the development and maintenance of OCD, TAF has emerged as a potential treatment target for obsessive-compulsive disorder (OCD). Previous research has demonstrated that TAF is indeed a malleable construct. This study aims to examine the effects of a multi-session, personalized cognitive bias modification (CBM) for thought-action-fusion (TAF) on improving obsessive-compulsive (OC) symptoms in a college sample.

All participants will be randomized into three groups: 1) CBM-TAF, 2) CBM-SMP (stress management psychoeducation), and 3) WL (waitlist). Participants randomized into either of the training groups (CBM-TAF or CBM-SMP) will complete a total of 6 training sessions (2x/week for 3 weeks), which employ the ambiguous-sentence completion task. To strengthen the training effect, participants will watch brief animated videos about TAF (CBM-TAF) or stress management (CBM-SMP) at the beginning of each session. Participants randomized into the WL group will only complete weekly assessments without any training sessions. All participants will complete pre-, post-training and 1-month follow-up assessments. All training sessions and assessments will be housed on a mobile-based web platform.

Eligibility Criteria:
Inclusion Criteria:

* A score of 18 or higher on the Dimensional Obsessive-Compulsive Scale (DOCS)
* Aged 18 or higher
* Access to a mobile device (i.e., smartphone)

Exclusion Criteria:

* Self-reported visual impairment that cannot be adjusted and will prevent them from clearly recognizing words and pictures on mobile screen
* Self-reported history of a bipolar disorder or psychotic disorder on a Diagnostic History Scale (DHS)
* Inability to adequately understand the study procedure as determined by the responses to comprehension questions provided at the time of the consent
rESP Medication With a Single Intravenous Administration and Dose Escalation to Explore the Tolerability ,Safety and Pharmacokinetic Characteristics

The study is a single center and open test, and the dose of successive incremental method was taken. In order to determine the tolerance and safety after a single intravenous injection of different doses of rESP in healthy subjects, the investigators had this trial. On the other hand, this study is to preliminarily explore the pharmacokinetics in healthy subjects.

The study is a single center and open test, and the dose of successive incremental method was taken. The study included 4 groups that is 0.5 ug/kg, 1.0ug/kg, 2.0ug/kg and 3.0ug/kg,the pharmacokinetic data (the screening period, before administration, after administration of 15, 30, 60 minutes, fourth, 8, 12, 24, 36, 48, 72 hours, seventh, 10, 14, 21, 28 days, 10 cases in each group) were collected. In order to determine the tolerance and safety after a single intravenous injection of different doses of rESP in healthy subjects, the investigators had this trial. On the other hand, this study is to preliminarily explore the pharmacokinetics in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-40 years old, male or female
2. Subjects are previously healthy, and whose physical examinations are normal 14 days ago before the screening examination
3. The BMI is 19-25Kg/m2 (BMI = weight / height2)
4. Without anemia, white blood cell and platelet counts are normal
5. Heart, lung, liver and kidney function are normal
6. Without smoke and wine hobby
7. Subjects voluntarily signing written informed consent.

Exclusion Criteria:

1. Allergic constitution or previous history of allergy of biological products;
2. Pregnant and lactating women;
3. Female subjects only take oral contraceptive pills and plan pregnancy during the clinical trials or within 3 months after administration; male subjects whose female partners plan pregnancy during the clinical trials or within 3 months after administration;
4. Female subjects received postmenopausal estrogen therapy;
5. With malignant hypertension or hypertension is poorly controlled or with previous history of thromboembolic diseases and diseases of hematopoietic system
6. Abnormal liver function ( AST or ALT is 2 times greater than the upper limit of the normal)
7. Hemoglobin is greater than or equal to 160g/L (male), 150 g/L (female)
8. The percentage of reticulocytes is greater than or equal to 3%
9. Serum iron protein \<20ng/ml
10. Subjects who donated blood 90 days before being enrolled or received a blood transfusion therapy or participate in other drug test
11. subjects who received recombinant erythropoiesis stimulating protein or rHuEPO 3 months before being enrolled;
12. recombinant erythropoiesis stimulating protein antibody (RESP) or endogenous erythropoietin (EPO) antibody positive;
13. drugs known to have damage to some organs were given 3 months before being enrolled;
14. subjects whose HBsAg, HBeAg, anti-HIV, anti-HCV and syphilis antibody are positive;
15. researchers believe that other factors are not suitable for the trial
Time-restricted Eating in Survivors Trial

Breast cancer survivors aged 60+ and with overweight/obesity who had completed chemotherapy 1-6 years earlier completed 8 weeks of 12-8 pm weekday-only time-restricted eating. The intervention was delivered by a registered dietitian call, twice-daily automated text messages asking about eating start/stop times, and three support phone calls.


Eligibility Criteria:
Inclusion Criteria:

* history of early-stage (I-III) breast cancer
* completed anthracycline-based chemotherapy 1-6 years earlier
* aged ≥60 years
* had a body mass index (BMI) \>25 kg/m2

Exclusion Criteria:

* taking lipid, glucose, or weight-lowering medications
* contraindications to maximal exercise testing or research MRI
* unstable thyroid disorder
* self-reported history of an eating disorder
* self-reported diagnosis of type 1 or 2 diabetes
* weight loss of ≥15 lbs in previous 3 months
* working night shifts
* could not provide consent in English
Evaluation of a Training in the Walking With Exosquelette

Stroke patients in the investigators rehabilitation unit follow gait trainings with robotic-assistive devices such as Lokomat. Patients able to walk alone are also assessed with 3D gait analysis. The objective of this study is to assess the effects of gait training in Lokomat on biomecanic gait parameters in stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* single stroke
* able to walk alone
* \> 18years

Exclusion Criteria:

* Cognitive impairments disturbing understanding
* Uncontrolled medical disorder associated
Prospective Clinical Utility Study to Assess the Impact of Decipher on Treatment Decisions After Surgery

The influence of Decipher test on urologist and patient treatment plan choices immediately post RP and at the time of PSA rise or BCR

This prospectively decision impact study will evaluate physicians and patient treatment plan choices before and after reviewing Decipher results for eligible patient cases. The clinical utility of Decipher will be evaluated for patients meeting the inclusion criteria at two time-points post-RP:

1. In the adjuvant setting: within 12 months after surgery (in the absence of detectable PSA rise of BCR)
2. In the salvage setting: post-RP with evidence of PSA rise or BCR (defined as PSA detectable and rising on 2 or more subsequent determinations)

A total of 150 patient cases, in each arm, will be prospectively selected from clinical sites. The study as a whole will enroll 300 patient cases.

As a condition of participation in the study, each clinical site must agree to provide a minimum of 10 patient cases.

Eligibility Criteria:
Inclusion Criteria:

1. Pathological T3 stage of disease (i.e., EPE or SVI), or
2. Positive surgical margins, or
3. Detectable PSA, defined as PSA detectable and rising on 2 or more subsequent determinations

Exclusion Criteria:

1. For adjuvant setting patients: Metastatic Disease (M+) prior to surgery
2. For salvage setting patients: Metastatic Disease at PSA rise
3. Failure of PSA to nadir after surgery
4. Received any neo-adjuvant prostate cancer treatment before radical prostatectomy
5. Received any adjuvant chemotherapy
6. Required patient clinical data is not available for evaluation of eligibility criteria
7. For adjuvant setting patients, any treatment received after surgery
8. For salvage setting patients, lack of documented treatment or management recommendation on file
9. Tissue specimen is inadequate for sampling and analysis
NIRS Measurement After SCP Block

Peripheral regional anesthesia induces a sympathectomy-like effect with neurovascular changes causing increased arterial blood flow and venodilatation .

Near-infrared spectroscopy (NIRS) can be applied to different kinds of tissue providing oxygen saturation by detecting the absorption and reflection of near-infrared light .

The effect on peripheral tissue oxygenation in patients undergoing arteriovenous fistula revision has not yet been examined. We postulate an increase in tissue oxygenation by sympathicolysis caused by peripheral regional anesthesia that might be the reason for beneficial outcome. The aim of our study was to demonstrate the effect of a supraclavicular plexus block in this group of patients.


Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing surgery under regional anaesthesia

Exclusion Criteria:

* patients refusal
A Multi-Centre, Randomised, Controlled, Masked Phase 2 Study of the Safety and Efficacy of KIO-101 Ophthalmic Solution, Versus Vehicle Control in the Treatment of Dry Eye Disease in Patients With Autoimmune Disease

A Multi-Centre, Randomised, Controlled, Masked Phase 2 Study of the Safety and Efficacy of KIO-101 Ophthalmic Solution, versus Vehicle Control in the treatment of Dry Eye Disease in Patients with Autoimmune Disease


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of autoimmune disease (psoriatic arthritis, Systemic Lupus Erythematosus (SLE), or fibromyalgia) ≤ 10 years
* Have an Ocular Discomfort Score (ODS) score of ≥3 at Screening
* Have an average VAS score ≥ 50 at Screening; and ≥ 40 at Baseline, Visit 2/Day 1
* Schirmer's 1 test \>1 but \< 10 mm at Screening.
* National Eye Institute (NEI) corneal fluorescein staining score of ≥ 4 at Screening (Day 14) provided that the total NEI score did not change \> ± 2 grades from Screening (Day -14) to Baseline (Day 1) visits, as confirmed by the investigator
* Have a Best Spectacle Corrected Visual Accuity (BSCVA) score of 20/200 (+1.0 LogMAR) or better in both eyes at both the Screening and Baseline visits
* Have a conjunctival hyperaemia score of Grade 2 or more on the Efron Scale in both eyes

Exclusion Criteria:

* Have a history or presence of any ocular disorder or condition (other than dry eye disease (DED)) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety
* Have an autoimmune based vasculitis
* Have a history of RA \> 10 years.
* Have a Schirmer's 1 test score of 0 to 1mm at Screening
* Have had a corneal transplant in either or both eyes
* Have had puncta or intracanalicular plug present in either eyelid within 1 year prior to the Screening Visit or anticipated plug insertion or occlusion at any time during the study
Tight Versus Liberal Blood Glucose Control in Adult Critically Ill Patients

Critically ill patients usually develop hyperglycemia, which is associated with an increased risk of morbidity and mortality. Controversy exists on whether targeting normal blood glucose concentrations with insulin therapy, referred to as tight blood glucose control (TGC) improves outcome of these patients, as compared to tolerating hyperglycemia. It remains unknown whether TGC, when applied with optimal tools to avoid hypoglycemia, is beneficial in a context of withholding early parenteral nutrition. The TGC-fast study hypothesizes that TGC is beneficial in adult critically ill patients not receiving early parenteral nutrition, as compared to tolerating hyperglycemia.


Eligibility Criteria:
Inclusion Criteria:

- Adult patient (18 years or older) admitted to a participating intensive care unit (ICU)

Exclusion Criteria:

* Patients with a do not resuscitate (DNR) order at the time of ICU admission
* Patients expected to die within 12 hours after ICU admission (= moribund patients)
* Patients able to receive oral feeding (not critically ill)
* Patients without arterial and without central venous line and without imminent need to place it as part of ICU management (not critically ill)
* Patients previously included in the trial (when readmission is within 48 hours post ICU discharge, the trial intervention will be resumed)
* Patients included in an IMP-RCT of which the PI indicates that co-inclusion is prohibited
* Patients transferred from a non-participating ICU with a pre-admission ICU stay \>7 days
* Patients planned to receive parenteral nutrition during the first week in ICU
* Patients suffering from diabetic ketoacidotic or hyperosmolar coma on ICU admission
* Patients with inborn metabolic diseases
* Patients with insulinoma
* Patients known to be pregnant or lactating
* Informed consent refusal
Left Atrial Appendage Occlusion Study III

Atrial fibrillation (AF) is a common heart rhythm disorder that leads to one-sixth of all strokes. Prevention of strokes in AF is achieved through the use of blood thinners such as coumadin. Although these blood thinners are effective, they are limited by the risk of serious bleeding, by physician and patient reluctance to use, and by noncompliance and discontinuation. The left atrial appendage is a structure on the upper chamber of the heart that is the most common source of stroke in patients with AF. This structure is easily accessible during open heart surgery for removal, and has been an area of interest for stroke prevention. However, there is currently no strong evidence that removing it works.

The LAAOS III trial will randomly (like the flip of a coin) assign patients with AF undergoing heart surgery for other reasons to have the left atrial appendage removed or not. These patients, other than this small procedure which has been shown to be quite safe, will be treated in the usual manner. The full study of 4700 patients, followed for an average of 4 years, will determine if removing the left atrial appendage can reduce stroke and other complications on top of usual therapy. A positive study will change the way heart surgery is performed on AF patients and results in a large reduction in the number of strokes in a large population. Further, it will promote further research into this approach that could be applied beyond AF patients undergoing heart surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Greater than 18 years of age
2. Undergoing a clinically indicated cardiac surgical procedure with the use of cardiopulmonary bypass
3. Have a documented history of atrial fibrillation or atrial flutter
4. CHA2DS2-VASc score ≥ 2
5. Have provided informed consent

Exclusion Criteria:

1. Patients undergoing off-pump cardiac surgery
2. Patients undergoing any of the following procedures:

   * heart transplant
   * complex congenital heart surgery
   * sole indication for surgery is ventricular assist device insertion
   * previous cardiac surgery requiring opening of the pericardium
   * mechanical valve implant
3. Patients who have had a previous placement of a percutaneous left atrial appendage closure device
Post Market, Prospective Multicenter Observational Study of the Safety and Performance of Bellavista Ventilator

This prospective post market clinical follow up (PMCF) study will evaluate the safety and performance of bellavista ventilator and the iFlow sensors in daily clinical routine.

A prospective, multicenter, single-cohort post market observational study, which will analyze data from neonatal, pediatric and adult patients, who are ventilated with the bellavista ventilator.

Ventilator data are continuously recorded in the bellavista ventilator. Patient related data will be recorded in an electronic case report form (CRF). Data from the ventilator and the eCRF are then combined and the primary and secondary endpoints calculated.

Eligibility Criteria:
Inclusion Criteria:

* Patient ventilated with bellavista
* Patient in ICU setting
* Signed informed consent per ethical committee requirements

Exclusion Criteria:

* Patients expected to be ventilated less than 12 hours
* The clinical care team does not agree with inclusion of the patient to the study
Immune Modulation From Trichuris Suis

Mucosal immunology during helminth infection

The present study investigates the effects of Trichuris suis on human mucosal and systemic immunity in a single self-infected individual.

Eligibility Criteria:
Inclusion Criteria:

* The included volunteer is a researcher within parasitology with main focus on Trichuris trichiura and Trichiura suis. He planned to infect himself and contacted our department with the purpose of being monitored during this infection for safety (medical supervision) and research reasons. The only clinical criterion for his inclusion in the study was that he was healthy.

Exclusion Criteria:

-