cyrilzakka/clinical-trials huggingface dataset:
Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial

The objective of the project is to find out whether cleansing the vagina before a cesarean delivery decreases the risk of complications and infections after having the baby. If this is the case, cleansing the vagina before cesarean delivery can help improve outcomes for many women and make their early postpartum recovery much more pleasant, giving a healthier start for the family.

Infectious morbidity frequently complicates cesarean delivery. Endometritis can complicate the postoperative course of a cesarean delivery 6-27% of the time. This complication, up to 10 times more frequent than after vaginal delivery, can lead to serious complications. Additionally, cesarean deliveries are frequently complicated by maternal fever and wound complications including seroma, hematoma, infection, and separation. These morbidities can lead to significant delay in a return to normal function. Our study will randomize 1000 women who are about to undergo a cesarean delivery into one of two groups. The control group will receive the standard surgical preparation of the abdomen alone, the current standard pre-cesarean preparation. The other group will also receive a povidone iodine washing/scrub of the vagina before the cesarean delivery. Maternal and surgical variables will be recorded. At one months postpartum, maternal outpatient data will be reviewed and the incidence of postpartum uterine infection, wound separations, and other wound and infectious complications will be determined and compared between the two treatment groups.

Comparison: Women receiving standard surgical abdominal cleansing versus women receiving standard abdominal and preoperative vaginal cleansing before cesarean delivery.

Eligibility Criteria:
Inclusion Criteria:

* Woman undergoing cesarean delivery
* At least 18 years of age

Exclusion Criteria:

* Allergy to iodine containing solutions
* Planned cesarean hysterectomy
* Prisoner
Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly

Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial (OPTMAL; NCT03252353), oral octreotide capsules demonstrated sustained biochemical response up to 13 months in patients with acromegaly previously managed with somatostatin analog injections (ref).

The objective of this study was to compare the efficacy, safety, and patient reported outcomes (PROs) between oral octreotide capsules and injectable somatostatin receptor ligands (SRLs).

This was phase 3, randomized, open-label, active controlled, multicenter study to evaluate the maintenance of response, safety and patient reported outcomes (PROs) in acromegaly patients treated with octreotide capsules and in patients treated with standard of care parenteral somatostatin receptor ligands (SRLs), who previously tolerated and demonstrated biochemical control on both treatments.

The core study consisted of three phases: a Screening phase, Run-in phase and a Randomized Controlled Treatment (RCT) phase.

Eligible patients who were biochemically controlled on parenteral SRLs were switched to octreotide capsules for a 26-week period Run-in phase. During this phase the effective dose for each patient was determined through dose titration.

Patients whose acromegaly has been controlled biochemically on octreotide capsules at the end of the Run-in phase entered a 36-week open-label RCT phase, where they randomized to continue on octreotide capsules or switch back to their injectable SRL treatment (as received prior to Screening).

Following the completion of the core study (Screening, Run-in and RCT phases), eligible patients were offered to enter the Study Extension phase and receive octreotide capsules until product marketing or study termination.

A Sub-study, performed in selected non-European sites, allowed patients with inadequate biochemical control on octreotide capsules during the Run-in phase to enter a Combination phase and receive co-administration of octreotide capsules with cabergoline tablets for a total of 36 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of acromegaly
* Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least 6 months
* Biochemical control (IGF -1 \< 1.3 x ULN and GH \< 2.5ng/mL)

Exclusion Criteria:

* Injections of long-acting somatostatin analogs, at a dosing interval \> 8 weeks.
* Pituitary radiotherapy within 5 years
* Pituitary surgery within six months
* Patients who previously participated in CH-ACM-01 study
* Any clinically significant uncontrolled concomitant disease
* Symptomatic cholelithiasis
* Previous treatment with:
* Pegvisomant, within 12 weeks
* Dopamine agonists, within 6 weeks
* Pasireotide, within 12 weeks
Optimization of Drug Prescribing in an Elderly Population of Geriatric Consultations

Aging is often associated with multiple chronic conditions conducting increased consumption of drugs. Drug therapy is necessary for the treatment of many diseases. However, misuse of drugs, particularly linked to the potentially inappropriate prescribing and polypharmacy, increases the iatrogenic risks and can lead to adverse events such as falls, cognitive decline, increased use to the health system: hospital admissions, emergency room visits, and institutionalization. These problems are common since about 20% of emergency room use in elderly patients due to an adverse event related to drugs. Nearly 28% of adverse events related to drug prescriptions could be avoided.

Interventions to optimize drug therapy showed a reduction in the number of potentially inappropriate medications, but their impact on health, has rarely been evaluated. If an association with death has been established, the link with the loss of functional autonomy, which leads to reduced quality of life and significant cost of care, has not been investigated. The evolution towards functional disabilities, frequent with aging has many causes, among which some could be prevented. The optimization of drug prescriptions could thereby delay or prevent the loss of functional autonomy by reducing the risk of adverse events, such as falls or cognitive decline and improving the management of chronic diseases. Our hypothesis is that an optimization program of the drug prescribing may slow progression to functional dependence. To assess the effect of the optimization program of drug prescribing on the level of functional autonomy, a multicenter Randomized Controlled Trial will be conducted in geriatric and memory consultations.

Expected results The implementation of the "OPTIM" program should enable optimization of drug prescribing in elderly patients and therefore slow or prevent progression to addiction. It should also help to develop and strengthen collaboration and communication between the team of geriatric consultation, the clinician pharmacist and referring physicians in town (private practice). In addition, pharmaceutical notice sent to referring physicians should help raise awareness of the prescription of drugs in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 65 and over;
* Patients received for the first time in a geriatric or memory consultation of a study recruiting centers;
* Patients living at home;
* Patients with the ability to express themselves orally or in writing in French sufficiently to carry out clinical assessments;
* Patients who led the last drugs prescription from his referring physician, at the geriatric/memory consultation (in current practice, patients should take the last prescription established by the referring physician);
* Patients accompanied by a caregiver.

Exclusion Criteria:

* Patients with no discernment;
* Patient put under legal protection;
A Vasoconstriction Study With LEO 90100

The purpose of this study is to compare the pharmacodynamic activity of LEO 90100 with Dermovate® cream, Dovobet® ointment, betamethasone dipropionate in LEO90100 vehicle, Synalar® ointment and LEO 90100 vehicle using a human skin blanching test.


Eligibility Criteria:
Inclusion Criteria:

* Following verbal and written information about the trial, the subject must provide signed and dated informed consent before any study related activities are carried out.
* Healthy male or female volunteers, 18 to 50 years old, both inclusive

Exclusion Criteria:

* Female subjects who are pregnant or who are breast feeding.
* Abnormal pigmentation of the skin or skin type that could, in any way, confound interpretation of the study results (skin type V and VI on the Fitzpatrick scale)
Instrument Tissue Interaction at the Grasp Site During Membrane Peeling of Epiretinal Membranes

Epiretinal membranes are a disease of the retinal surface, that may affect visual acuity and cause metamorphopsia. Using vitrectomy with membrane peeling, postoperative improvement of visual acuity and metamorphopsia may be achieved in a majority of patients. Diaz et al. demonstrated that there are postoperative changes in the "nerve fiber layer" after ILM peeling, but in that study, no recording of instrument/tissue interactions was performed using iOCT.

The aim of this study is to examine dipping into retinal tissue with the forceps during grasping of the epiretinal membrane at the starting point of peeling with iOCT.

Epiretinal membranes are a disease of the retinal surface, that may affect visual acuity and cause metamorphopsia, occurring in approximately 20% of the population older than 60 years, as reported by Mitchell et al.. Using vitrectomy with membrane peeling, postoperative improvement of visual acuity and metamorphopsia may be achieved in a majority of patients. The surgical method has been used for some time, the first report on the surgical method of vitrectomy with membrane peeling was published by Machemer and dates back to 1978. Since the introduction of intraoperative optical coherence tomography (iOCT), intraoperative iatrogenically induced changes in retinal tissue can be detected and correlated with postoperative changes. Leisser et al. has been able to record "stretching" of the retinal tissue using this technique and has also been able to record the rarely occurring subfoveal and extrafoveal elevations of the ellipsoidal zone due to membrane peeling. These changes did not significantly affect postoperative visual acuity, according to Leisser et al., but did affect the development of postoperative microscotomas. Nevertheless, iOCT has the potential to document instrument tissue interactions such as dipping into retinal tissue with the forceps during grasping of the ERM at the starting point of membrane peeling. Diaz et al. demonstrated that there are postoperative changes in the "nerve fiber layer" after ILM peeling, but in that study, no recording of instrument/tissue interactions was performed using iOCT.

The aim of this study is to examine dipping into retinal tissue with the forceps during grasping of the epiretinal membrane at the starting point of peeling with iOCT.

Eligibility Criteria:
Inclusion Criteria:

* Vitrectomy with membrane peeling with iOCT assistance due to an ERM in the time-period from 1.6.2014 to 31.12.2016 (early phase) or 1.11.2020 to 31.7.2022.
* Age 18 and older

Exclusion Criteria:

* iOCT was not used during surgery
* bad image quality, excluding analysis of images
The Efficacy and Safety of Drug Loaded Microsphere Bronchial Artery Chemoembolization (DEB-BACE) Combined With Anlotinib and Adebelimumab in the Third Line Treatment of Advanced NSCLC: a Prospective, Single Arm, Single Center, Exploratory Clinical Study

The goal of this clinical trial is to learn about Drug loaded microspheres for bronchial artery chemoembolization (DEB-BACE) combined with anlotinib and adebelimumab in patients with advanced NSCLC after second-line treatment.

The main question it aims to answer is:

The efficacy and safety of Drug Loading Beads Bronchial Arterial Chemoembolization (DEB-BACE) combined with Anlotinib and Adebelimumab in the third line treatment of advanced NSCLC.

Participants will receive DEB-BACE treatment, rest for 1 week and then undergo 1 cycle of treatment with combination of Anlotinib and Adebelimumab. With a maximum of 4 DEB-BACE treatments depending on the therapeutic effect, followed by continued treatment with Anlotinib and Adebelimumab.


Eligibility Criteria:
Inclusion Criteria:

1. Age\>18 years old, gender unlimited;
2. According to the Diagnosis and Treatment Guidelines for Primary Lung Cancer (2018 Edition), NSCLC was diagnosed by pathological histology;
3. TNM staging is III - IV;
4. Failure of second-line treatment according to the CSCO guidelines;
5. ECOG PS score ≤ 2 points;
6. Estimated survival time\>3 months;
7. Sign informed consent form

Exclusion Criteria:

1. Individuals who have previously received interventional therapy (iodine particle implantation, ablation, BACE treatment), or have received PD-L1 inhibitor immunotherapy during the first or second line standard treatment period of the patient;
2. Patients with other malignant tumors that have not been cured;
3. White blood cells\<3 × 109/L, absolute value of neutrophils\<1.5 × 109/L, neutrophil/lymphocyte ratio ≥ 3, platelet count\<50 × 109/L, hemoglobin concentration\<90 g/L;
4. Liver and kidney dysfunction (creatinine\>176.8) μ Mol/L; Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)\>twice the normal upper limit;
5. Central squamous cell carcinoma with cavity features;
6. Incorrectable coagulation dysfunction or concomitant active massive hemoptysis;
7. Patients with concurrent active infections who require antibiotic treatment;
8. Uncontrollable hypertension, diabetes, and cardiovascular diseases with obvious symptoms;
9. Contrast agent allergy;
10. Women with concurrent pregnancy or lactation
A Single Arm Trial of Oxaliplatin and 5FU With Concurrent Radiation in Patients With Metastatic Rectal Cancer

This trial is a single-arm study for patients presenting with both local and metastatic adenocarcinoma of rectum. The aims of the trial are (1) to determine the tolerability rate, and (2) to determine toxicity rates, pelvic and distant response rates in patients with locally advanced rectal cancer in the presence of distant metastasis who are treated with an interdigitating chemotherapy (oxaliplatin/5-fluorouracil \[5FU\]) and radiotherapy regimen.

* Week 1: Oxaliplatin 100 mg/m2 Day 1 (over 2 hours), leucovorin 200mg/m2 Day 1 concurrent with oxaliplatin over 2 hrs, then 5-FU 400mg/m2 bolus Day 1, then 5-FU continuous infusion 2.4 g/m2 over 46 hours from Day 1.
* Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day and continuous infusion 5-FU 200 mg/m2/day on the days of radiotherapy,
* Week 6: as per Week 1,
* Weeks 8-10: as per Weeks 3-5
* Weeks 11: as per Week 1.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with previously untreated and pathologically proven adenocarcinoma of the rectum with distant metastasis who would benefit from combined local therapy and systemic chemotherapy.
2. Lower border of tumour must be within 15cm of anal verge.
3. Age \>= 18 years.
4. ECOG Performance Status 0-2
5. Absolute Neutrophil Count \> 1.5x10\^9/L, haemoglobin \> 100 g/L, and platelets \> 100x10\^9/L.
6. Renal: Creatinine clearance \>= 55 mL/min (using radioisotope renal scan or derived from serum creatinine using the Cockcroft-Gault formula).
7. Bilirubin \<= 2.0 x upper limit of normal.
8. ALT \<= 5 x upper limit of normal
9. Life expectancy in excess of 3 months.
10. No symptomatic peripheral neuropathy \> grade 2.
11. Males or non-pregnant, non-lactating females. Female patients of child-bearing potential, not surgically sterilized, must use an adequate form of contraception (oral contraceptive pill or barrier method).
12. Signed informed consent

Exclusion Criteria:

1. Prior pelvic radiotherapy
2. Febrile intercurrent illness or infection.
3. History of myocardial infarction within the previous six months or unstable cardiac disease or any other medical condition likely to compromise the safe delivery of chemotherapy or radiotherapy.
4. Concurrent treatment with other anti-cancer therapy.
5. Significant medical conditions which in the opinion of the investigator would compromise the planned delivery of the chemotherapy and radiotherapy or which may be potentially exacerbated by these modalities.
6. Locally recurrent rectal cancer
A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Atopic Dermatitis

The purpose of this study is to assess the efficacy and safety of RO7790121 in participants with moderate to severe atopic dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

* AD diagnosis confirmed by a dermatologist according to the Hanifin/Rajka criteria at least 1 year prior to screening
* Moderate to severe AD
* At least once daily use of an additive-free, bland emollient for at least 7 days prior to the baseline visit and during the study

Exclusion Criteria:

* Evidence of other skin conditions that would interfere with the assessment of AD, including, but not limited to, for example cutaneous T-cell lymphoma, allergic contact dermatitis
* IV, IM, IL, and oral corticosteroids (inhaled, ophthalmic drops, and nasal corticosteroids are allowed) within 4 weeks of the baseline visit and during the study
* Topical treatment for AD including, but not limited to topical corticosteroids, topical calcineurin Inhibitors, topical PDE-4 inhibitors, , prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea or filaggrin within 7 days prior to the baseline visit and during the study
* Any active infection or other active skin diseases that required treatment with parenteral anti-infectives within 4 weeks or oral anti-infective treatment within 2 weeks prior to baseline
* Acquired or congenital immunodeficiency
* Systemic therapies that are also used in the treatment of AD, including, but not limited to methotrexate, cyclosporine, azathioprine, mycophenolate mofetil within 4 weeks of the baseline visit and during the study
Cross-sectional Study to Assess Tolerability of the Trivalent Recombinant Vaccine in Individuals Between 18 and 64 Years Old Using the Vaccinees Perception of Injection

This study aims to assess patient-reported experiences post-vaccination with RIV3 using the VAPI instrument, identify drivers for vaccine choice in each case, and assess the cross-validity of VAPI, by establishing magnitude of correlations to EQ-5D-5L domains.

As a feasibility endpoint, this study aims to describe the socio-demographic differences and feasibility of matching between recipients of RIV3 vaccine and mRNA vaccines for COVID-19.

This study will be conducted through an online survey that respondents will complete only if they meet the inclusion criteria and give their consent to continue to the main questionnaire. Each participant will complete the survey only once. Participants will provide details about their demographic data, health status, perceptions of flu vaccination and injection site reactions, as well as drivers for vaccine choice and future vaccine use.

Eligibility Criteria:
Inclusion Criteria:

* Be aged 18-64 years old
* 50 to 64 years will be the main age group for recruitment
* 18 to 49 years will allow flexibility to face potential recruitment challenges
* Have received a RIV3 vaccine within the last 2 months
* Be able to provide explicit consent to participate in the study
* Reside in continental US (Puerto Rico is excluded)
* Communicate and read fluently in English (US)
* Be physically able to participate in a 30 min online survey using an internet-enabled computer or other device (such as a tablet or smartphone)

Exclusion Criteria:

* Inability to participate in survey
* Receipt of any other vaccine outside those pre-specified within the past three weeks, and including concomitant vaccination
* Receipt of co-administered vaccination
Citalopram Titration in Early Non-responder Patients With Major Depressive Disorders

Major depressive disorder is a common mental disorder and the leading cause of disability worldwide. According to the Canadian Network for Mood and Anxiety Treatment, early improvement following an antidepressant treatment is correlated with response and remission. Escalation of an antidepressant dose after 2 weeks, as opposed to 4 to 8 weeks, is proposed to favor early improvement. However, this has never been tested systematically in a controlled study involving major depressive disorder patients that are non-responders to their antidepressant treatment.

The investigators sought to assess whether it is feasible to perform a prospective randomized controlled double-blind feasibility study with a 2 week run-in period and 3 parallel groups randomized controlled study using citalopram. Citalopram has physicochemical properties compatible with over-encapsulation and a has a simple titration that allows the study of early dose increase.. It is among the most prescribed antidepressant in the province of Quebec and at the Hospital Maisonneuve-Rosemont - University family medicine group (U-FMG).

Since establishment of a randomized controlled trial is complex and expensive, a feasibility design is appropriate to identify all the obstacles and to minimize sources of possible bias (recruitment, follow up, resources).

Eligibility Criteria:
Inclusion Criteria:

* Understand french or english
* Primary diagnostic of major depressive disorder based on the Diagnostic and Statistical Manual of Mental Disorders criteria (5th edition)
* Prescription of citalopram
* Citalopram started less than 4 days ago
* Able to receive informed consent
* Not participating to another study

Exclusion Criteria:

* Pregnancy or breastfeeding
* Unable to participate to follow-up
* Hypersensitivity to citalopram or any component of the formulation
* Known QT interval prolongation or congenital long QT syndrome
* Hepatic impairment (Child Pugh A, B or C)
* Renal impairment (Clcr \< 30 ml/min)
* Known cytochrome P450 2C19 poor metabolizers
* History of non-response to citalopram
* Head trauma or severe cognitive impairment
* Substance-related and addictive disorders controlled less than 3 months or uncontrolled
* Schizophrenia or psychotic disorder
* Mixed depression
* History of manic/hypomanic episodes
* Use of prohibited drugs : monoamine oxidase inhibitors, cytochrome P450 2C19 inhibitors, drugs at risk of causing prolongation of the QT interval, cimetidine, pimozide and antidepressors taken for another psychiatric condition.