cyrilzakka/clinical-trials huggingface dataset:
Nationwide Study of Artificial Intelligence in Adenoma Detection for Colonoscopy

The goal of this trial is to determine whether use of a Computer Assisted Detection (CADe) programme leads to an increase in ADR for either units or individual colonoscopists, independent of setting or expertise

This is a case-control study comparing adenoma detection rate (ADR) in hospitals (and individual colonoscopists), before, during and after use with an artificial intelligence unit called GI Genius™ (GIG). GIG is a Computer-assisted detection (CADe) module that assists the human colonoscopist in real-time, by detecting and marking out polyps during colonoscopy. It has been shown to be effective in expert colonoscopists, but the effect in non-expert, general, colonoscopists is not known.

The investigator wish to deploy GIG into colonoscopy through the UK using a step-wedge design. Sites will be randomly allocated a start date for GIG deployment, collecting data for four months prior to this. In this way, all sites will have the active intervention and will provide their own case-control data. (4 months collection prior to activating GIG, 4 months with GIG, 4 months afterwards without GIG)

The study will concentrate on non-expert colonoscopists, to determine whether GIG can increase ADR. Patients will undergo the same colonoscopy that they would have had in any case, with no additional trial visits or interventions. There will be no alteration to the usual care pathway from the patient's perspective.

If the investigator can prove GIG increases ADR in this way, it will provide support to roll out this technology routinely to improve the quality of colonoscopy nationwide.

Eligibility Criteria:
Inclusion Criteria:

* Any patient aged 18-85 scheduled for colonoscopy by current NHSE / British Society of Gastroenterology criteria

Exclusion Criteria:

* Colonoscopy being performed for polyp surveillance
* Unable to provide informed, written consent
The Effect of Acupuncture Treatment on Sleep Quality in Post-Stroke Patients

The aim of this study is to investigate the effectiveness and reliability of acupuncture treatment in patients experiencing impaired sleep quality after a stroke. Additionally, the goal is to reduce the need for multiple medications and/or high-dose drug usage in the treatment of these complications in patients

The aim of this study is to evaluate the effect of acupuncture therapy on sleep quality in patients experiencing insomnia in the early post-stroke period. In this prospective, randomized controlled, single-blind study, 70 ischemic stroke patients undergoing inpatient rehabilitation were included. Participants were randomly divided into two groups: the acupuncture group receiving acupuncture therapy and standard rehabilitation program. The control group receiving only the standard rehabilitation program. The acupuncture group received acupuncture treatment twice a week for 4 weeks. Sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI). The PSQI scores were assessed three times at baseline, at the 4th week, and at the 8th week. The results of the study indicated that the acupuncture group demonstrated a significant improvement in sleep quality compared to the control group. Significant differences were observed between the baseline PSQI scores and the PSQI scores at the 4th week in both the acupuncture and control groups (p: 0.000 and p: 0.008). The change between baseline and 8th-week PSQI scores was also significant (p: 0.000 and p: 0.000). However, in the acupuncture group, the decrease in PSQI scores was significantly greater compared to the control group. The addition of acupuncture therapy to standard treatment resulted in a significant improvement in sleep quality. Additionally, the baseline PSQI scores were found to be correlated with the severity of depression.This study suggests that acupuncture therapy can be an effective intervention for improving sleep quality in patients with early post-stroke insomnia.

Eligibility Criteria:
Inclusion Criteria:

* being between 18-80 years of age,
* having a minimum of 2 and a maximum of 6 months elapsed since the ischemic stroke, -volunteering to participate in the study,
* having a mini-mental test score above 17.

Exclusion Criteria:

* history of insomnia or depression before stroke,
* psychiatric medication use,
* psychiatric illness, aphasia, sleep apnea syndrome,
* decompensated cardiac, renal, or hepatic insufficiency, pregnancy,
* presence of infection in the areas where acupuncture would be applied.
Prevalence and Outcome of Brachial Artery Endothelial Function in Morbidly Obese Patients Undergoing Bariatric Surgery

The relation between obesity and ischemic heart disease (IHD) is under considerable debate. The reduction in all-cause mortality and, more specifically, the reduction in cardiac-related mortality seen after weight-loss surgery, may be due to regression or slowing developement of subclinical IHD. Function of cells lining the arteries (endothelium) is closely related to the state of IHD and its measurement can serve as a surrogate marker for the existence and severity of IHD. The investigators hypothesize that the prevalence of undiagnosed IHD in the morbidly obese population is high and that following surgery for weight reduction there is a halt in the progression, or even a regression in its severity.

The study includes measurement of endothelial function before and after weight-reducing surgery.


Eligibility Criteria:
Inclusion Criteria:

* Morbidly obese patients who fulfill the NIH criteria for surgical intervention.

Exclusion Criteria:

* Patients deemed unfit for surgery
* Pregnant women, or who are attempting conception.
* Subjects with any history of myocardial infarction, coronary artery bypass grafting surgery, coronary angiography with angioplasty and/or stenting, or any lesion \> 50% of the coronary artery luminal diameter, cerebrovascular accident, or peripheral vascular disease with abnormal electrocardiograms and/or echocardiography.
* History of drug or alcohol abuse.
* Chronic liver disease.
LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Intra-abdominal Infection (cIAI)

The purpose of the study was to evaluate whether LYS228 can be developed for the treatment of complicated intra-abdominal infections.

It was planned that LYS228 exposure across patients with varying renal function would be evaluated during the study to confirm that LYS228 concentrations are predicted to be adequate to treat the patient population. It was planned that the PK exposure of the initial 8 patients would be analyzed.

PK analysis was not conducted as per protocol the first analysis required 8 patients.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 18 to 85 years of age with visual confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis including at least one inclusionary diagnosis during surgical intervention.

Exclusion Criteria

* Any of the excluded diagnoses: abdominal wall abscess, small bowel obstruction, traumatic bowel perforation undergoing surgery within 12 hours, perforation of gastroduodenal ulcer with surgery within 24 hours, an intra-abdominal process that is not likely caused by infection.
* Pre-operative treatment of any duration with non-study Drug systemic antibiotic therapy for peritonitis or abscess is not allowed unless certain criteria are met.
* Concomitant bacterial infection at time of enrollment requiring non-Study Drug antibiotics and that may interfere with the evaluation of clinical response to the study antibiotic.
* Known non-abdominal source of infection, including endocarditis, osteomyelitis, abscess, meningitis, or pneumonia diagnosed within 7 days prior to enrollment.
* Patient has an Acute Physiology and Chronic Health Evaluation II (APACHE II) score \> 30 or is considered, in the judgement of the investigator, unlikely to survive 4 weeks (e.g. rapidly progressive terminal illness, including septic shock).
* Patients that meet sepsis criteria as defined by the quick sequential sepsis-related organ failure assessment (qSOFA).
* Women of child-bearing potential unless they are using highly effective methods of contraception during dosing and for 7 days after stopping study treatment.
TRIAD Burden of Illness Mucositis Study

Observational (non-drug) study to look at the risks and burden of mucositis (sores) involving the mouth, throat and intestines in patients receiving chemotherapy and radiation therapy treatment for various cancer types.

This comprehensive, observational study will prospectively elicit the true incidence (risk) and health and economic burdens of mucosal toxicities associated with anti-cancer drug and radiation therapy. This study will examine the burden of illness of gastrointestinal mucositis (defined as mucositis involving the mouth, esophagus, or small intestine) in the most significant regimens used to treat the most common types of cancers. It is an international investigation in which 1600 patients being treated with specific regimens for cancers of the head and neck, breast, colon, lung (NSCLC)and Non-Hogkin's Lymphoma will be prospectively enrolled from centers throughout the US, Canada, Europe and Australia.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Ability to understand the protocol and willing to provide written informed consent
* Membership in one of the following sub-cohorts:

  1. Histologically proven oral cavity or oropharyngeal cancers planned to receive a full cycle of daily single fraction radiation therapy (with or without boost) or IMRT +/- chemotherapy.
  2. Histologically proven laryngeal or hypopharyngeal cancers planned to receive a full cycle of daily single fraction radiation (with or without boost) +/- chemotherapy.
  3. Histologically proven adenocarcinoma of the colon or rectum planned to receive a minimum of 2 cycles of FOLFOX +/- Avastin or Erbitux.1 cycle defined as 2 doses of FOLFOX.
  4. Histologically proven adenocarcinoma of the colon or rectum planned to receive a minimum of 2 cycles of FOLFIRI +/- Avastin or Erbitux. 1 cycle defined as 2 doses of FOLFIRI.
  5. Adenocarcinoma of the breast planned to receive a minimum of 2 cycles of TAC.
  6. Histologically proven adenocarcinoma (any primary) planned to receive a minimum of 2 cycles of capecitabine.
  7. Adenocarcinoma of the breast planned to receive standard or dose-dense doxorubicin and cyclophosphamide (AC) followed by paclitaxel (T) (4 cycles AC followed by 2 cycles T).
  8. Stage 3A or 3B non-small cell lung cancers planned to receive daily single fraction radiation with or without boost (1 fraction daily for 5-6 weeks) +/- Carbo/Taxol.
  9. B-cell Non-Hodgkin's lymphoma (NHL) planned to receive at least 2 cycles of CHOP-14, CHOEP-14, CHOP-DI-14, EPOCH-14 or CHOP-21 +/- rituxan
Korean Post-marketing Surveillance for Reyataz®

The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Reyataz® so that the regulatory authority can manage the marketing approval properly


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 13 years of age with HIV-1 who are on Reyataz® treatment at the time of enrollment and have never been participated in this study previously or who are initiating Reyataz® treatment for the first time in the real-life conditions in its registered indication(s) as required by KFDA

Exclusion Criteria:

* According to Warning/Caution in local label
A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension

The purpose of this study is to measure the efficacy and safety of baxdrostat in participants with uHTN or rHTN. The main objective is to compare the difference in SBP change from baseline at Week 12 of treatment between participants receiving 2 mg baxdrostat or 1 mg baxdrostat tablets and participants receiving placebo tablets.

This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered QD orally, on the reduction of SBP in approximately 300 participants aged ≥ 18 years with HTN (≥ 140 mmHg at Screening; ≥ 135 mmHg at randomisation) despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uHTN); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (rHTN).

Eligibility Criteria:
Inclusion Criteria:

* Male or female participants must be ≥ 18 years old.
* Mean seated SBP on automated office blood pressure measurement (AOBPM) ≥ 140 mmHg at Screening.
* Fulfil at least 1 of the following 2 criteria:

  1. uHTN subpopulation: have a stable regimen (≥ 4 weeks) of 2 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator.
  2. rHTN subpopulation: have a stable regimen (≥ 4 weeks) of ≥ 3 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator.
* Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening.
* Serum potassium (K+) level ≥ 3.5 and \< 5.0 mmol/L at Screening.• Mean seated SBP on AOBPM ≥ 135 mmHg at Baseline.

Exclusion Criteria:

* Mean seated SBP on AOBPM ≥ 170 mmHg.
* Mean seated DBP on AOBPM ≥ 105 mmHg.
* Serum sodium level (Na+) \< 135 mmol/L at Screening.
* Has the following known secondary causes of hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.
* NYHA functional heart failure class IV at Screening.
Predictive Value of Periodic Repolarization Dynamics in Post-Infarction Patients

Increased periodic repolarization dynamics (PRD) indicate increased risk of death in cardiac patients. This study thoughts to prospectively validate the prognostic value of PRD in post-infarction patients.

Periodic repolarization dynamics (PRD) reflect periodic changes of repolarization instability located in the low-frequency spectral range. Level of PRD can be assessed using a high resolution surface ECG recorded in the 12-leads of Frank leads configuration during resting conditions.

Increased levels of PRD have been associated with sympathetic overactivity and increased risk of mortality in survivors of acute myocardial infarction and patients undergoing a clinically indicated exercise test.

Eligibility Criteria:
Inclusion Criteria:

* previous myocardial infarction \>4 weeks
* age \>18 years

Exclusion Criteria:

* life expectancy \< 1 year due to non-cardiac causes
* unable to give informed consent
Rheos Feasibility Trial

The Rheos Feasibility Trial is designed to assess safety, device performance, and protocol parameters of the CVRx Rheos Baroreflex Therapy in patients with severe hypertension that are refractory to full drug therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Be at least 21 years of age.
2. Have been assessed to have bilateral carotid bifurcations located at or below C3-C4.
3. Have an office cuff systolic blood pressure greater than or equal to 160 mmHg and a 24-hour ambulatory systolic blood pressure greater than or equal to 150 mmHg despite at least one month of full therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic.
4. Must be certified by the investigator hypertension specialist as compliant with taking full doses of medication.
5. Have signed a CVRx approved informed consent for participation in this study.

Exclusion Criteria:

1. Have been diagnosed with:

   * Baroreflex failure
   * Cardiac bradyarrhythmias
   * Chronic atrial fibrillation
2. Had a heart transplant
3. Have carotid atherosclerosis producing a 50% or greater reduction in linear diameter as determined by ultrasound or angiographic evaluation as determined within six months of enrollment in the trial.
4. Have Grade C ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation.
5. Have prior surgery or radiation in either carotid sinus region.
6. Currently have implanted electrical medical devices such as cardiac pacing, defibrillation or neurologic stimulation systems.
7. Are pregnant or contemplating pregnancy during the 13-month follow-up period.
8. Currently undergoing dialysis.
9. Have hypertension secondary to a treatable cause.
10. Have clinically significant cardiac valvular disease.
11. Are unable or unwilling to fulfill the protocol medication compliance and follow-up requirements.
12. Are unlikely to survive the protocol follow-up period.
13. Are enrolled in another concurrent clinical trial.

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An Efficacy and Safety Study of Ivacaftor in Patients With Cystic Fibrosis and Two Splicing Mutations

This postmarketing N of 2 study is designed to evaluate the efficacy and safety of open-label ivacaftor treatment in two sisters with cystic fibrosis and pancreatic sufficiency.

The two sisters have a splicing mutation that is predicted to respond favorably to ivacaftor therapy. In addition to measurement of usual clinical outcomes (i.e. lung function, nutritional status), there is great interest on the impact on nontuberculous mycobacteria (NTM) airways infection.

Subjects will undergo sputum cultures at baseline and monthly during treatment, initially in the absence of anti-NTM therapy but with the intent to treat with antibiotics if there is persistence of the infection in cultures. Other clinical outcomes will include changes in sweat chloride, lung function and weight. Safety measures will include periodic assessment of liver enzymes. All serious and non-serious adverse events will be collected

Eligibility Criteria:
Inclusion Criteria:

* Subjects are \>18 years of age and able to provide informed consent.
* Subjects reside in the US and are willing to be treated with ivacaftor.
* Subjects have the splicing mutation of interest.
* Subjects are willing and able to perform requirements of the study.

Exclusion Criteria:

* There are no relevant exclusion criteria for this n-of-2 study.
Efficacy of T1675 Versus Placebo in Patients With Bilateral Treated Moderate Dry Eye Syndrome

To evaluate the efficacy of a 6-month (± 14 days) dietary supplementation period with T1675, a per os omega 3 and omega 6 polyunsaturated essential fatty acid dietary formulation, versus placebo in patients with bilateral treated moderate dry eye syndrome

The aim of the present study is to evaluate the efficacy of a 6-month (± 14 days) dietary supplementation period with T1675 versus placebo in patients with bilateral moderate dry eye syndrome already treated with tear substitutes, and to point out, through several parameters, the best efficacy parameter that could be used for a future clinical phase III study.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent.
* Male or female aged from 18 to 90 years old.
* Known treated bilateral dry eye.
* Dry eye syndrome confirmed by ocular examination with a fluorescein and/or lissamine green staining, BUT and Schirmer, performed within the last 12 months before Inclusion Visit, for both eyes.
* Bilateral symptomatology suggestive of dry eye defined by: at least one of the following ocular symptoms suggestive of dry eye (burning, stinging, dryness feeling, sandy and/or gritty sensation, light sensitivity, reflex tearing, ocular fatigue) and Questioning on patient's feeling (score \>=3).
* Fulfilling the following criteria of dry eye syndrome in both eyes defined by: Keratoconjunctivitis defined by a lissamine green score ≥ 4 (Van Bijsterveld score) and Schirmer test \<= 10 mm in 5 min or BUT \< 10 s

Exclusion Criteria:

* severe dry eye symptom
* eyelid dysfunction
* severe progressive rosacea
* any relevant ocular anomaly interfering with ocular surface
* best corrected far visual acuity \<= 1/10
* history of ocular allergy
* traumatism, infection, inflammation within last 3 months
* ocular surgery and laser within the last 3 months
* lasik, laser, PKR within the last 12 months
* contact lenses
* any concomitant nutritive supplementation, vitamins
* any topical concomitant treatment
A Study of AK111 in Subjects With Moderate-to-severe Plaque Psoriasis

This is a Phase Ib clinical study of multiple dose escalation of AK111 in subjects with moderate-to-severe plaque psoriasis

This is a randomized, double-blind, placebo-controlled phase Ib clinical study. This study aims to determine the safety, tolerance, pharmacokinetics(PK) and Pharmacodynamics (PD) characteristics, immunogenicity and preliminary clinical efficacy of multiple dose escalation administration of AK111 in subjects with moderate-to-severe plaque psoriasis..

Eligibility Criteria:
Inclusion Criteria:

1. Moderate to severe plaque-type psoriasis diagnosed for at least 6 months;
2. Subjects with moderate-to-severe plaque psoriasis at baseline, who were defined as follows: Body Surface Area (BSA) ≥ 10%, PASI ≥ 12 and SPGA score ≥ 3;
3. Subjects with a history of systemic therapy or phototherapy for psoriasis at least once before, or suitable to receive systemic therapy or phototherapy for psoriasis assessed by investigator;
4. Women of childbearing age is not pregnant or lactating, and the subjects and their partners voluntarily take contraceptive measures considered effective by the investigator during the treatment period and at least 6 months after the last receipt of the study drug.

Exclusion Criteria:

1. Forms of psoriasis other than chronic plaque-type psoriasis;
2. History or evidence of active/latent tuberculosis;
3. Positive results of confirmatory serology test for hepatitis B, hepatitis C,HIV or syphilis at screening;
4. History of serious infection within 2 months before screening;
5. History of malignancy of any organ system;
6. Inadequate washout period for prior psoriatic therapy;
7. Previous use of secukinumab, ixekizumab or any other drug that targets IL-17 or IL-17 receptor;
8. Any medical conditions, in the opinion of the investigator, would place the subject at risk, interfere with study participation or study results interpretation.
Erector Spinae Plane Block with Dexmedetomidine and Bupivacain Versus Dexamethasone and Bupivacain for Postoperative Analgesia in Patients Undergoing Abdominal Surgeries

To compare the analgesic effect of dexmedetomidine combined with bupivacaine versus dexamethasone combined with bupivacaine for ultrasound-guided ESPB for postoperative pain control in patients scheduled for abdominal surgeries


Eligibility Criteria:
Inclusion Criteria:

Age :18 years old and older. Patients undergoing open abdominal surgery.

Exclusion Criteria:

1. Patient refusal
2. known sensitivity or contraindication to any of study drugs
3. contraindications for local anesthesia
4. Patients with local infection at site of puncture
5. uncooperative patients
6. history of psychological disorders or chronic pain and significant liver or renal disease.