cyrilzakka/clinical-trials huggingface dataset:
Intra-discal Steroid Injection for MODIC I Discopathy

To assess the efficacy on pain level at 1 month and 12 months of a steroid injection in the inter-vertebral disc for patients with chronic back pain and inflammatory discopathy on magnetic resonance imaging.

Hypothesis: delivering anti-inflammatory drugs in situ may decrease back pain in patients with inflammatory discopathy

Objective: to assess the efficacy on pain level of a steroid injection in the inter-vertebral disc for patients with chronic back pain and MODIC I discopathy on MRI

Methods: a multicenter double blind randomized control trial Setting: 3 tertiary care hospitals in France Patients: 134 patients with disabling chronic low back pain not relieved by usual recommended treatments and MODIC I (inflammatory) discopathy on MRI Intervention: Injection of 25 mg of methylprednisolone in the inter-vertebral disc during a discography (intervention group, 67 patients) or discography alone (control group, 67 patients) Outcome measures: The primary outcome measure is pain level assessed on a 11-point numeric scale (0-100) at 1 month. Success is defined as less than 40 on pain numeric scale at 1 month. Secondary outcome measures are pain level at 12 months, Disability (Quebec questionnaire), quality of life (SF-12) at 1 and 12 months, anxiety and depression (HAD), analgesics and anti-inflammatories during the last week, return to work, assessment of the disabilities at 1 and 12 months and disc inflammation (on MRI) at 12 months. Tolerance and adverse effects will be recorded.

Trial duration: 36 months(24 months for inclusion and 12 months follow-up) Follow-up visits: at 1, 3, 6, and 12 months Statistical analysis: intention to treat

Eligibility Criteria:
Inclusion criteria :

* More than 18 and less than 70 years old
* Low back pain
* Daily pain for at least 3 months
* Pain level during the last 48 hours \> 40 on the numeric pain scale (0-100)
* Lack of efficacy of usual recommended treatments and of other spine steroid injections (epidural or facet joints injections)
* Modic I discopathy on MRI
* Intra-discal injection at least 6 months before inclusion
* Written informed consent
* Social security
* Medical examination

Non inclusion criteria :

* Pregnancy
* Hypersensitivity to methylprednisolone or contrast
* Local or general infection
* Previous disc surgery less than 6 months
* Steroid treatment
* Previous infectious spondylodiscitis
* Ankylosing spondylitis
* Sciatica with neurologic defects
* Uncontrolled psychiatric conditions
* Inability to read or understand French language
* Anti-vitamin K treatments
* Severe coagulation diseases
* Fever \> 38 or sedimentation rate \> 20
* Discopathy with MODIC 1 signal on several different lumbar stages
Dexamethasone Dose for Postoperative Nausea and Vomiting Prophylaxis in Obese Patients

compare the effectiveness of different doses of dexamethasone used for postoperative nausea and vomiting prophylaxis in obese patients and in normal weight patients.

compare the effectiveness of different doses of dexamethasone used for postoperative nausea and vomiting prophylaxis in obese patients.

compare the effectiveness of dexamethasone given in 4 mg and 8 mg doses in obese patients with 4 mg doses of dexamethasone in normal weight patients.

4 mg iv dexamethasone will be administered to normal weight patients at induction of anesthesia. This group will be classified as the control group. In obese patients (BMI\>30 kg/m2), one group will receive 4 mg dexamethasone and other group will receive 8 mg dexamethasone at induction.

Patients will receive general anesthesia with volatile anesthetics and tramadol will be administered IV at the end of surgery.

Postoperative nausea and vomiting, postoperative pain, blood glucose, wound infection, time to oral intake, hospital stay will be compared.

Eligibility Criteria:
Inclusion Criteria:

High risk patients for postoperative nausea and vomiting:

* Female
* No smoking
* BMI =18.5-24.9 for control group
* BMI \>30 for other groups
* undergo laparoscopic cholecystectomy

Exclusion Criteria:

* Diabetes mellitus
The Danish On-pump, Off-pump Randomization Study (DOORS)

Background: Coronary artery bypass grafting (CABG) can be performed either with or without the use of cardiopulmonary bypass (CPB) to obtain myocardial re-vascularisation. The investigators hypothesize that CABG without the use of CPB may reduce the risk of perioperative death, stroke, myocardial infarction and other serious complications.

The aim of the present study is to compare the incidence of complications and the clinical efficacy of CABG with and without the use of CPB in elderly patients.

Conventional coronary artery bypass grafting (CCABG) using cardiopulmonary bypass has for decades been applied to obtain myocardial re-vascularisation and, hence, improved quality of life and survival. It does, however, bear a risk of death, stroke, myocardial infarction and other serious complications.

During recent years, an equivalent operation performed on the beating heart without cardiopulmonary bypass (off-pump coronary artery bypass grafting, OPCAB) has gained popularity helped by the advent of mechanical stabilization devices and improved surgical techniques. Observational studies suggest that this technique is associated with a lower incidence of stroke, per operative arrhythmias and even mortality than conventional CCABG. This is especially the case in elderly patients and patients with significant co-morbidity.

Only few randomised, controlled trials have been conducted and most of these included mainly or only low-risk, relatively young patients. These studies have documented the safety and efficacy of OPCAB compared with CCABG, but none of the trials has had the statistical strength to determine whether the rate of serious complications is lower after OPCAB operations. One recent study found graft patency to be significantly lower after OPCAB than after CCABG operations.

The investigators find that there is a need of a larger scale randomised trial to compare the results of CCABG and OPCAB operations, especially in elderly patients. This patient group is poorly represented in earlier randomised trials, whereas observational studies and theoretical considerations imply that they may benefit the most from avoiding cardiopulmonary bypass.

Aims: Primarily, to compare the incidence of death, stroke and myocardial infarction after CCABG and OPCAB procedures in a population of elderly patients. Furthermore, to compare quality of life and graft patency, and cost- effectiveness after CCABG and OPCAB.

Eligibility Criteria:
Inclusion Criteria:

* Age seventy years or above
* Admitted for first time coronary artery bypass operation

Exclusion Criteria:

* Given information cannot be understood
* Aortic crossclamping not safe due to calcification
* Preoperative cardiac conditions demanding cardiopulmonary bypass
* Re-do cardiac surgery
* Patients requiring operation within the same day after conference
The Use of Contextualised Body Data in Cardiac Rehabilitation (CR)

KiCS1 study : Digital health for current hospital- based Cardiac rehabilitation programmes to increase effectiveness and patient outcomes.

Cardiac rehabilitation (CR) after a heart attack has shown to be more effective than any other medication given after such an event. It is a recommended therapy by NICE. However, only 44% of eligible patients attend rehabilitation and only half of these complete the course. Novel ways to increase uptake and compliance are needed.

In this study, calorie burn and physical activity data will be collected using a validated, CE marked physical activity monitor, herein referred to as Ki monitor. Data can be uploaded to an online behaviour change platform that incorporates personalised feedback in the context of their bespoke requirements for CR to empower people to self-care at home using their personal everyday physical activity. This can be closely monitored and support can be given on the contextualised feedback by healthcare professionals. A small pilot study has been carried out to establish wearability of a physical activity monitor in a CR cohort, which has demonstrated a high level of acceptability.

We now wish to extend this pilot to a randomised study designed to test the effectiveness of using contextualised body data to influence physical activity in a free-living environment amongst patients undergoing CR, based on the current ACPICR standards for Daily Activity and At-home Training. All patients referred for CR will be invited to take part. These will be randomised to the usual care (UC) group or the contextualised data feedback (CDF) group. Both groups will wear the Ki monitor for eight weeks. The UC group will receive usual care, the CDF group will receive usual care with the addition of contextualised feedback on their activities based on the physical activity data.

Eligibility Criteria:
Inclusion Criteria:

All patients referred to the cardiac rehab programme will be invited to take part in the study.

Exclusion Criteria:

1. Individuals using a pacemaker or other internal medical device.
2. Unable to access a computer or tablet with internet access to view the online platform.
3. Unable to access a smartphone or tablet with bluetooth connectivity and internet access to upload data from the activity monitor.
4. Unwillingness to take part.
Ranibizumab Treatment of Diabetic Macular Oedema With Bimonthly Monitoring After a Phase of Initial Treatment

This study evaluates a new investigational treatment regimen of three consecutive monthly doses of ranibizumab followed by an as-needed treatment regimen, with monthly follow-up for the first three months then two-monthly follow-up until 18 months in patients with visual impairment due to diabetic macular oedema.The aim of the study is to determine if this treatment regimen is effective and safe in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 1 or Type 2 diabetes mellitus.
* Patients with visual impairment due to focal or diffuse diabetic macular oedema (DMO), and not other causes, in at least one eye who are eligible for laser treatment in the opinion of the investigator.
* Best Corrected Visual Acuity between 78 and 24 letters in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS)-like grading charts (approximate Snellen equivalent of 20/32 to 20/320).
* Increased central retinal thickness which, in the opinion of the investigator, is due to DMO.

Exclusion Criteria:

* Concomitant conditions in the study eye that could prevent the improvement of visual acuity on study treatment.
* Active intraocular inflammation (grade trace or above) or infection in either eye at enrollment.
* History of uveitis in either eye at any time.
* Structural damage within 0.5 disc diameters of the centre of the macular in the study eye likely to preclude improvement in visual acuity following resolution of macular oedema.
* Planned medical or surgical intervention during the 18-month study period.
* Uncontrolled glaucoma in either eye at screening.
* Blood pressure systolic \> 160 mmHg or diastolic \> 100 mmHg at screening.
* Ocular conditions in the study eye that require chronic concomitant therapy with topical ocular or systemically administered corticosteroids.
* History of acute thromboembolic event within 4 months of screening.
* Untreated diabetes mellitus.
* Evidence of advanced, severe or unstable concomitant disease or its treatment which may interfere with evaluations or put the patient at special risk.

Other protocol-defined inclusion/exclusion criteria may apply
Evaluation of Tolerance, Efficacy and Safety of an Hydrolyzed Formula in Infants With IgE/Non-IgE Mediated CMA.

The aim of this interventional study is to assess the hypoallergenicity of a new formula in infants having a cow milk allergy (CMA), whatever the type of CMA, meaning in both IgE-mediated and non-IgE-mediated CMA patients.

This will be tested through a double-blind placebo controlled food challenge (DBPCFC) taking place over 2 or 3 separate days, in hospital.

If the child tolerates the tested formula during the DBPCFC, he will be fed with the test formula during the second study phase. There will be monthly visit and parents will be asked to fill in diaries.

Briefly, on two separate days, the placebo formula and the TEHCF will be introduced at increasing doses under medical supervision, and appearance of allergic symptoms will be witnessed and recorded if any. The week after, and more particularly the 72 hours after each food challenge day, child's parents will be instructed to report to the investigator any delayed reaction that may occur. In case the TEHCF induces an allergic reaction, the child's participation will be ended. Otherwise, the child will enter the second study part, lasting 4 months and during which the usual formula taken by the child will be totally replaced by the TEHCF.

Eligibility Criteria:
Inclusion Criteria:

* between 1 and 24 months old
* having a CMA proven in the last 3 months prior to inclusion
* free of clinical allergic symptoms for at least one week (i.e., successfully fed an elimination diet)
* whose parent(s)/legal guardian(s) signed the informed consent form.

Main Exclusion Criteria:

* Children mainly (\&amp;gt;1 breastfeeding/day) or exclusively breastfed, with maternal willingness to continue breast-feeding
* Children with a mean formula intake lower than 250 ml/day
* Children with past anaphylactic reaction(s)
* Children with chronic (non acute) FPIES

  -- Children presenting with any situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the subject,
* Children already participating in another clinical trial
A Study of 5 Fluorouracil and the Anti-Tumor Activity of ADH300004 and 5 Fluorouracil in Subjects With Incurable Solid Tumors

5 fluorouracil (5 FU), one of the most actively investigated anti-cancer drugs, is rapidly inactivated by the enzyme dihydropyrimidine dehydrogenase (DPD). ADH300004 blocks DPD. This study will test the safety and effects of oral ADH300004 14 hours prior to oral 5 FU in subjects with refractory solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* \> or = 18 years of age
* Advanced or metastatic solid tumors:

Part 1: Histologically proven advanced or metastatic solid tumors refractory to standard therapy or for which no standard therapy exists

Part 2: Histologically proven advanced and/or metastatic solid tumor of one of the following 6 histologies, that is refractory to standard curative therapy or for which no curative therapy exists: HCC, NSCLC, gastric cancer, cervical cancer, prostate cancer, and breast cancer

* Radiologically documented measurable or evaluable (non-measurable) disease
* Adequate performance status and organ function, as evidenced by hematologic and biochemical blood testing
* Willing to not receive fluoropyrimidine containing chemotherapy for 8 weeks after the last dose of ADH300004 in this study

Exclusion Criteria:

* Cytotoxic chemotherapy, radiotherapy, or investigational drug within 28 days prior to study entry
* Non-cytotoxic cancer therapy within 14 days prior to study entry
* Portal hypertension with bleeding esophageal or gastric varices within the past 3 months
* Ascites that is refractory to conservative management
* Inability to take oral medication
* Active peptic ulcer disease
* Known hypersensitivity to 5-FU or ADH300004
* Stroke, major surgery, or other major tissue injury within 30 days before study entry
Treatment of Nodular Basal Cell Carcinoma (BCC) With Imiquimod 5% Cream After Curettage

To assess the efficacy of treating a nodular basal cell carcinoma with imiquimod cream after initial treatment with curettage

The primary objective of this study is to evaluate the efficacy of imiquimod 5% cream on nodular BCC lesions treated 5x/week for 6 weeks after primary treatment with curettage without electrodesiccation. The secondary objective of this study is to evaluate the cosmetic outcome after treatment of the lesions using this modality.

Eligibility Criteria:
Inclusion Criteria:

1. Are willing and able to give informed consent;
2. Are at least 18 years of age;
3. Are willing to comply with all study requirements, evaluations, and procedures
4. Have 1 clinically typical, visible nodular BCC lesion which meets the following criteria:

   * a primary lesion (not recurrent, not previously treated or biopsied)
   * non-infected
   * size between 0.25 and 1.5 cm2
   * located at least 1 cm from the eyes, nose, mouth, ear, and hairline to exclude the H-zone of the face
   * clinically consistent with nodular BCC
   * histologically consistent with nodular BCC and have no histological evidence of a morpheaform or micronodular pattern
   * suitable for treatment with surgical excision
   * easily identifiable and treatable by subject or reliable subject representative
5. Are free of any significant physical abnormalities or previous scarring in the potential application site area that may cause difficulty with examinations.
6. Are willing to stop using over-the-counter retinol products or products containing alpha or beta hydroxyacids in the treatment and surrounding area 8 hours prior to treatment with the imiquimod cream and clinic visits.

Exclusion Criteria:

1. Have evidence of clinically significant, unstable, cardiovascular or immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or disease that may interfere with completion of the study.
2. Have any dermatological disease in the treatment or surrounding area that may be exacerbated by treatment with imiquimod or cause difficulty with examination.
3. Have a BCC lesion located within 1 cm of the eyes, nose, mouth, ear, and hairline.
4. Are pregnant at the screening or treatment initiation visit.
5. Have known allergies to any excipient in the study cream
6. Have undergone any surgical procedures in the potential treatment area within 4 weeks of the screening/treatment initiation visit. In addition, skin in the potential application area must be healed.
Effect of Rubus Occidentalis Extract on Plasma Glucose Levels in Subject With Prediabetes

The purpose of this study is to determine whether Rubus occidentalis extract could improve fasting or postprandial serum glucose levels, and related metabolic markers among patients with prediabetes (impaired fasting glucose and/or impaired glucose tolerance).


Eligibility Criteria:
Inclusion Criteria:

* 19 years of age or older
* prediabetes (fasting plasma glucose 100-125mg/dl, and/or post 75g OGTT plasma glucose 140-199mg/dl)

Exclusion Criteria:

* pregnant women
* taking anti-hyperglycemic agents within 3 months at the time of enrollment
* history of heart failure, myocardial infarction, cerebral infarction
* uncontrolled hypertension (systolic BP \> 160mmHg, or diastolic BP \> 100mmHg)
* serum triglyceride level \> 500mg/dl
* kidney dysfunction (serum Creatinine \> 30% of upper normal limits)
* hepatic dysfunction (AST, ALT \> 3 times of upper normal limits)
* taking systemic glucocorticoids within 1 month
Real Life Study on Iron Isomaltoside 1000 in the Treatment of ID in CKD, Heart Failure, ObGyn, IBD, Cancer and Elective Surgery (Real-CHOICE).

Real-CHOICE - designed as a prospective, longitudinal, observational, non-interventional study - will investigate the attitude of patients and physicians towards IV (intravenous) iron therapy in general and IIM (iron isomaltoside 1000) treatment particularly before and after IIM treatment in iron deficient patients with or without anemia in the real-world clinical setting after commercial availability of this product in Switzerland.


Eligibility Criteria:
Inclusion Criteria:

* Legally capable male and female patients, aged ≥ 18 years (no upper limit);
* Written informed consent of the patient with regard to the pseudonymized documentation;
* The patients are not selected by specific inclusion or exclusion criteria, but by the indication listed in the Swiss SmPC (Summary of Product Characteristics) of Monofer®;
* Decision is taken to treat the patient with IIM in accordance with the current Swiss SmPC of Monofer® and by prescription; this decision is taken prior to and independent from the inclusion into the study.

Exclusion Criteria:

* Any contraindication regarding IIM treatment as specified in the Swiss SmPC of Monofer®;
* Retrospective observation of IIM infusion;
* Current or upcoming participation in an interventional clinical trial;
* Prior IV iron treatment or transfusion within 3 months prior to enrolment;
* Instable and/or untreated comorbidities potentially hampering the observation of the primary outcome parameter of this study;
* Prisoners or persons who are compulsorily detained (involuntarily incarcerated).
4D-150 in Patients With Diabetic Macular Edema

Phase 2 randomized, active-controlled, double-masked, dose-ranging trial in adults with Diabetic Macular Edema (DME).

This Phase 2 trial is a prospective, multicenter, randomized, active-controlled, double-masked dose-ranging trial to evaluate the safety and efficacy of 4D-150 in adults with DME. The trial will be conducted in two parts: Dose Confirmation and Dose Expansion.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Type I or Type II diabetes mellitus with macular thickening secondary to DME involving the center of the fovea; diagnosis of DME must be within 2 years of Screening
* Demonstrate clinical response to on-study aflibercept injection in the study eye.
* Decreased visual acuity attributable primarily to DME
* BCVA in the study eye between 25 and 83 ETDRS letters, inclusive (\~20/320 and 20/25, respectively) at Screening
* Study eye amenable to IVT injection
* Sufficient clear ocular media, pupil dilation and fixation in the study eye to permit adequate imaging; ability to perform tests of visual and retinal function and structure; and ability to comply with other protocol-specified procedures
* Provide written informed consent

Exclusion Criteria:

* Macular edema in the study eye considered to be secondary to a cause other than DME
* Systemic anti-VEGF treatment (e.g. sunitinib, bevacizumab, pazopanib) within 6 months, or anticipated need for systemic anti-VEGF therapy during study participation
* Systemic corticosteroids (oral, intravenous, intramuscular, intra-articular) or other immunosuppressive medications within 3 months
* Received an investigational drug, agent, device, or therapy (ocular or non-ocular) in the 3 months (or at least 5 half-lives, whichever is longer) prior to 4D-150 administration (Day 1)
* Prior gene therapy (ocular or non-ocular) and/or ocular stem cell therapy in either eye
* Any concurrent ocular condition in the study eye that is likely to require surgical intervention (e.g. cataract surgery) during the 2 year (104 week) study duration

Note: Other inclusion/exclusion criteria apply.