cyrilzakka/clinical-trials huggingface dataset:
Digital Videos Disc and Printed Guidelines and Improve the Knowledge of Patients Undergoing Cardiac Catheterization

This study is randomized clinical trial to verify the effect of nursing guidelines for patients undergoing left cardiac catheterization on an outpatient basis. Comparing three approaches to direct guidelines about the procedure:

* printed,
* digital video disc (DVD)
* conventional guidelines provide by nursing team

This study is randomized clinical trial to verify the effect of nursing guidelines for patients undergoing left cardiac catheterization on an outpatient basis. Comparing three approaches to direct guidelines about the procedure:

* guidelines printed, (GOI) with informative material
* guidelines through a digital video disc (GDVD) six minutes
* conventional guidelines provide by nursing team

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing the procedure were included, with age equal or superior to 18 years

Exclusion Criteria:

* patients who had already undergone previous procedures similar severe comorbidities, illiterate and who came to the facility to urgently
Kinetics of Inflammation Markers in Maternal Plasma: Study of the Correlation With the Diagnosis of Chorioamnionitis in Women Hospitalized for Spontaneous Rupture of the Fetal Membranes

The principal aim of this study is to help obstetricians to diagnose chorioamniotic infection early, in cases of premature rupture of the fetal membranes before 34 WA, by proposing earlier and more specific markers of infection than FBC and CRP. The aim is to reduce vital and functional risk of acute chorioamnionitis for the mother, the fetus or the newborn,.

If the kinetics profile of one or several markers correlates strongly with the diagnosis of chorioamnionitis, it could be used in clinical practice, possibly in the context of another clinical study.

The results of the study presented here are destined to be published in obstetrics journals.


Eligibility Criteria:
Inclusion Criteria:

* Term between 24 and 34 WA
* Spontaneous rupture of the fetal membranes
* Singleton pregnancy
* Age \> 18 years

Exclusion Criteria:

* Delivery within the hour following admission
* Hospitalisation before 24 WA or after 34 WA
* Hemorrhagic placenta previa or retroplacental hematoma, known auto-immune or inflammatory disease
* Infection with human immunodeficiency virus (HIV)
* Refusal to provide consent.
* Patients provided for in articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code (e.g.: minors, adults under guardianship, etc...)
Single Retainer All-Ceramic Resin-bonded Fixed Dental Protheses

The purpose of this prospective study was to evaluate the clinical outcome of all-ceramic RBFDP with a cantilevered single-retainer design made from zirconia ceramic. To evaluate the impact of the adhesive system used an established resin cement with an integrated adhesive monomer (Panavia 21 TC) and a resin cement with a separate primer (Multilink Automix with Metal/Zirconia Primer) were compared within the study on a randomized basis.

The aim of the present randomized study was to evaluate wether the difference in bond strength of Panavia and Multilink Automix with Metal/Zirconia Primer to densely sintered zirconia ceramic (IPS e.max ZirCAD, Ivoclar Vivadent) has any impact on the clinical outcome of all-ceramic RBFDP with a cantilevered single-retainer design.


Eligibility Criteria:
Inclusion Criteria:

* sufficient oral hygiene
* one caries free or almost caries free abutment tooth available
* sufficient space for the retainer wing available
* patients willingness to return at regular intervals for at least 5 years for evaluation

Exclusion Criteria:

* clinical symptoms of bruxism
* collision, full or semi-contact sports (Boxing, Karate)
* pregnant women
* untreated advanced periodontitis
Baseline Cardiovascular Measurements in Pediatric Spinal Cord Injury

Following spinal cord injury (SCI), the body loses normal control of blood pressure and heart rate, and there is a risk of sudden and dangerous increases in blood pressure, namely, autonomic dysreflexia (AD). It is important to be aware of baseline blood pressures and heart rates in individuals in order to detect AD. However, baseline values vary in developing children, and may be more variable in children with SCI. Thus, the objective of this study is to determine baseline blood pressure and heart rate measurements in children with SCI during rest and during urodynamic testing.

The investigators hypothesize that 1) blood pressures will increase with increasing age and body mass index; 2) heart rate will decrease with increasing age; 3) blood pressures will increase with increase in bladder filling; 4) blood pressures will increase will increase with increasing duration of injury.


Eligibility Criteria:
Inclusion Criteria:

* children and adolescents with spinal cord injury
* age 18 years or younger

Exclusion Criteria:

* known history of hypertension, cardiac, renal, or thyroid disease
* recent surgical procedure less than 2 weeks prior to admission or visit
* fever or signs of active infection or inflammation
New Diagnostic Markers In Dignosis Of Complicated Appendix

Most common cause of acute abdomen is acute appendicitis delay dignosis of acute appendicitis lead to complications as perforation this study examined efficacy of hyperbilirubinemia\&hyponatremia as indicator of complicated appendicitis


Eligibility Criteria:
Inclusion Criteria:

* all patient admitted for acute appendicitis underwent surgery and post operativly confirmed histopathology of acute appendicitis

Exclusion Criteria:

* patient with liver disease Liver transplantation Chronic alcoholism Congental biliary disease Pregnancy Appendicular neoplasm Hemolytic disease Hepatocellular carcinoma
Plasma Protein Binding Characteristics of Voriconazole

The purpose of this study is to investigate the influence of hypoalbuminemia on the protein binding characteristics of the antifungal drug voriconazole in ICU patients.


Eligibility Criteria:
Inclusion Criteria:

* treated with voriconazole

Exclusion Criteria:

* None
Ibuprofen Gel or Capsaicin Cream for my Painful Knee Osteoarthritis?

Despite evidence that topical non-steroidal anti-inflammatory drugs (NSAIDs) and capsaicin are effective in osteoarthritis (OA), it is still unclear why they work for some people but not others. The investigators are undertaking an individual patient data (IPD) meta-analysis to identify responders according to patient characteristics, however, no studies report the presence of synovial hypertrophy or neuropathic-like pain. These two traits are of interest as they may be used to optimise the treatment effects of the two drugs which work via different mechanisms to reduce pain in OA. The investigators are therefore conducting this pilot n-of-1 trial series.

This pilot n-of-1 trial series will investigate whether a person with OA, who has a different balance between inflammatory and neuropathic pain, shows a preference between these mechanistically different treatments. The trial will also be used to offer recommendations on the use of n-of-1 trial series for individualised (precision) medicine in OA.


Eligibility Criteria:
Inclusion Criteria:

* Men and non-pregnant women who have had ultrasound and radiographic assessments in the Knee Pain in the Community study

  o Premenopausal women will need to be on an acceptable contraceptive method
* Aged 40-95 years
* Knee pain between 4-8 on the NRS
* Knee osteoarthritis - defined as knee pain plus radiographic changes, based on previous questionnaire responses and radiographic findings

  * Knee pain: individuals with knee pain in and around the knee on most days for at least a month.
  * Radiographic changes: definite joint space narrowing and definite osteophytes (each scoring two or more on the Nottingham Line Drawing Atlas) in the tibiofemoral and/or patellofemoral compartments
* Predominantly neuropathic or inflammatory phenotypes based on previous questionnaire responses (not current status)

  * Predominantly neuropathic phenotype: painDETECT Questionnaire (PDQ) \> 13 and synovial hypertrophy (SH) \<4 mm
  * Predominantly inflammatory phenotype: SH \> 4 mm and PDQ \< 13
  * If we cannot recruit enough people with the above thresholds, we will base recruitment on the overall distribution of PDQ and SH scores from the population. The third tertile of PDQ and the first tertile of SH for neuropathic and the first tertile of PDQ and the third tertile of SH for inflammatory phenotypes.

Exclusion Criteria:

* Inability to give informed consent
* Daily use of oral NSAIDs for the last two weeks
* Prior use of Ibuprofen gel or Zacin on the affected knee(s)
* Terminal or untreated major mental illness
* Pregnancy or breastfeeding
* Hypersensitivity or allergy to topical NSAIDs, capsaicin, or other ingredients in the preparations. This includes individuals that experience attacks of asthma, urticaria, or acute rhinitis that are precipitated by NSAIDs
* Current treatment for stomach or duodenal ulcers
* Total joint replacement of affected joint
* Renal failure
* Taking anticoagulants
Periosteal Electrical Dry Needling for Knee Osteoarthritis

The purpose of this research is to treat patients with knee osteoarthritis (OA) with periosteal electric dry needling (PEDN). It is also to determine the optimal "maintenance" regiment (i.e. maintenance treatments, one maintenance treatment every other month, or one maintenance treatment per month) required to maintain improvements in pain and function following PEDN. Physical therapists commonly use PEDN to treat knee OA, and previous studies suggest that this treatment is useful for reducing pain and improving function in patients with osteoarthritis. However, an appropriate maintenance treatment strategy to maintain these outcomes is presently unknown.

Patients with knee osteoarthritis will be randomized to receive periosteal electrical dry needling 1-2 treatments per week for 6 weeks (up to 10 sessions total) followed by either: 1. no maintenance treatments, 2. one maintenance treatment every other month or 3. one maintenance treatment per month.

Eligibility Criteria:
Inclusion Criteria:

1. Adult over the age of 18 years old:
2. Report of knee pain of at least 2/10 per NPRS (0---10 scale) for \>3 months
3. Report of at least 3 of the following per Altman et al. (1986) (sensitivity = 95% / specificity = 69%)

   1. Over 50 Years of age
   2. Less than 30 minutes of morning stiffness
   3. Crepitus on active motion
   4. Bony tenderness
   5. Bony enlargement
   6. No palpable warmth of Synovium

Exclusion Criteria:

1. Report of red flags to manual physical therapy to include: hypertension, infection, diabetes, peripheral neuropathy, heart disease, stroke, chronic ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc.
2. History of physical therapy, massage therapy, chiropractic treatment, or injections for knee pain in last 4 weeks.
3. History of a partial or total knee replacement on the painful lower extremity.
4. History of a surgical procedure on either lower extremity in last 12 months.
5. Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:

   1. Weakness involving a major muscle group of the lower extremity.
   2. Diminished patella or achilles tendon reflex
   3. Diminished or absent sensation to pinprick in lower extremity dermatome.
6. Involvement in litigation or worker's compensation regarding knee pain.
7. Any condition that might contraindicate the use of periosteal electric dry needling
8. The patient is pregnant.
Effects of Oral Glutamine Supplementation on Insulin Resistance and Functional Intestinal Disorders in Obese Patients.

Obesity, which has a prevalence at 15% in France, is a major public health concern. Altered glycemic control and irritable bowel syndrome (IBS) are frequently observed in obese patients and lead to reduce the quality of life. In the last decades, the role of gut microbiota and intestinal permeability has been underlined in obesity, glycemic control and IBS. Interestingly, experimental and clinical data show that glutamine, an amino acid, is able to maintain or restore intestinal permeability in different conditions. We thus hypothesize that oral glutamine supplementation may restore gut barrier function contributing to improve glycemic control and IBS-symptoms. Our project will thus aim to evaluate the effects of 8 weeks - oral glutamine supplementation on glycemic control and IBS symptoms in obese patients in a blinded randomized controlled trial. Placebo group will received protein powder. 55 obese patients will enrolled in each arm and will received oral glutamine supplementation or protein powder (10g t.i.d.) during 8 weeks. Blood and feces samples and intestinal permeability assays will be performed at baseline (w0), after 8 weeks of supplementation (w8) and then after 8 weeks of a wash-out period (w16).


Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 18 to 65 years
* Patient with h grade II or III obesity (body mass index equal or higher than 35 kg/m2)
* Patient with insulino-resistance (fasting glycaemia ≥ 1g/l et \< 1.26 g/l)
* Patient with irritable bowel syndrome (Rome IV criteria ≥ 2)

Exclusion Criteria:

* Patient with Known liver insufficiency (prothrombin time \< 70%)
* Patient with Known kidney failure (GFR \< 60 ml/mn)
* Patient with Known intestinal diseases such as inflammatory bowel diseases
* Vomiting patients (≥ 1/ day) during the last 4 weeks
* Patient Previously received bariatric surgery or digestive surgery
* Patient Using laxatives or protein powder during the 4 last weeks
* On going Pregnancy
Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients

International, post-authorisation non-interventional study to evaluate real-life effectiveness, safety and utilisation patterns of Octapharma's FVIII concentrates Nuwiq, Octanate, and Wilate in previously untreated and minimally treated severe haemophilia A patients in routine clinical practice.

Octapharma's FVIII concentrates have been tested in clinical trials and registered for treatment of haemophilia A; however, as haemophilia A is a rare disease, the numbers of patients treated in studies so far are limited. For previously untreated patients (PUPs), who are typically young children, and for minimally treated patients (MTPs), who have been exposed to only minimal FVIII dosages, there is a general interest to increase the body of data on treatment effectiveness and safety, particularly related to inhibitor development. Also, specifically for PUPs, treatment algorithms are not standardized, e.g. with respect to utilisation, dosage, frequency or optimal start age of FVIII prophylaxis. Real world evidence derived from a non-interventional study (NIS) can describe product utilisation and demonstrate value over a product's life cycle and facilitate benefit-risk assessments. The purpose of this study is thus to evaluate product utilisation, effectiveness and safety, including inhibitor development information, in severe haemophilia A PUPs and MTPs, who have been prescribed Octapharma's FVIII concentrates.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients of any age and ethnicity
* Severe haemophilia A (FVIII:C\<1%)
* Decision to prescribe Octapharma's FVIII concentrate before enrollment into the study
* Either
* No previous treatment with FVIII concentrates or other blood products containing FVIII (PUPs) OR
* Less than 5 Exposure Days (EDs) to FVIII concentrates or other blood products containing FVIII (MTPs), if
* data are available on all previous treatment, AND
* they did not develop an inhibitor at any time point, OR
* they developed an inhibitor during treatment with an Octapharma FVIII concentrate AND continue treatment with THIS Octapharma FVIII concentrate (in the presence or absence of emicizumab).
* Voluntarily given, fully informed written and signed consent obtained before any study-related data documentation is conducted (obtained from the patient's parent/legal guardian)

Exclusion Criteria:

* Diagnosis with a coagulation disorder other than haemophilia A
* Concomitant treatment with any systemic immunosuppressive drug
* Participation in an interventional clinical trial during the time period evaluated
* Participation in another non-interventional study of Octapharma
Comparison of Vortioxetine and Desvenlafaxine in Adult Patients Suffering From Depression

The purpose of this study is to compare the efficacy of vortioxetine versus desvenlafaxine after 8 weeks of treatment in patients that have tried one available treatment without getting the full benefit

The study will consist of a screening period of up to 14 days before the Baseline Visit, followed by an 8-week Treatment Period with vortioxetine or desvenlafaxine. A Safety Follow-up Visit will be performed approximately 4 weeks after the Primary Outcome/Withdrawal Visit.

At Baseline, patients will be equally randomised (1:1) to 1 of the 2 treatment groups for an 8-week, double-blind Treatment Period.

Eligibility Criteria:
Inclusion Criteria:

* The patient has a primary diagnosis of single or recurrent MDD, diagnosed according to DSM-5®. The current MDE must be confirmed using the Mini International Neuropsychiatric Interview (MINI).
* The patient has a MADRS total score ≥24 at screening and baseline.
* The patient has had the current MDE for ≥3 months and \< 12 months.
* The patient has been treated with an SSRI as monotherapy (citalopram, escitalopram, paroxetine, sertraline) for at least 6 weeks at licensed dose for the current MDE with a partial response and is a candidate for a switch in the investigator's opinion.
* The patient wants to switch antidepressant treatment.

Exclusion Criteria:

* The patient has any other disorder for which the treatment takes priority over treatment of MDD or is likely to interfere with study treatment or impair treatment compliance.

Other in- and exclusion criteria may apply
Autologous Nanofat Grafting by Injection Versus With Microneedling in Post-burn and Traumatic Atrophic Scars

This study aims to evaluate the efficiency autologous nanofat injection versus autologous nanofat delivered by microneedling in management of post burn atrophic and traumatic scars.


Eligibility Criteria:
Inclusion Criteria:

* 1. Males and females between 18-60 years old. 2. Post-burn or traumatic atrophic scar \> 6 months duration (16). 3. Patients not receiving any treatments for the scar within the past 3 months.

Exclusion Criteria:

* 1. Patients with contractures, hypertrophic and keloid scars. 2. Patients with history of bleeding disorders or coagulopathy, or on anticoagulant therpy.

  3. Diabetes and other systemic diseases that may be complicated by the procedure.

  4. Pregnant and lactating females. 5. BMI less than 18.5 6. Patients with scars at the donor site
Outcomes and User Acceptance of the IntelliVue Alarm Advisor Software (USA)

This Clinical Study will be conducted as a comparative study focusing on usability and efficiency by comparing alarm burden pre- and post- implementation of an "Alarm Advisor software".

In a first phase of data collection (pre-implementation) all alarms of an intensive care unit population are recorded.

In an interim period an Alarm Advisor software will be introduced to the unit. In a second phase (post-implementation) the same set of alarm data will be recorded.

The "Alarm Advisor" Software can identify alarms based on criteria set by the medical staff and provide hints to reduce alarms and alarm nuisance (e.g. by proposing adjustments of alarm limits).

The effect of reduction of recurring nuisance alarms through the implementation of the Alarm Advisor shall be evaluated.

Eligibility Criteria:
Inclusion Criteria:

- Patients admitted to the intensive care units during the study periods

Exclusion Criteria:

- none
Standing Behavior After Installation of Height-Adjustable Desks

The purpose of this research study is to determine whether height-adjustable desks change sitting and standing time at work and away from work, engery expenditure, dietary intake, and body composition. Intermittent peroids of standing made possible by height-adjustable desks may help to impart long-term health benefits.


Eligibility Criteria:
Inclusion Criteria:

* Being one of the 18 scientists and support staff who have sedentary jobs
* Voluntarily make the choice to replace their current fixed-height sitting desk for a sit-to-stand height-adjustable desk
* Consents to study conditions

Exclusion Criteria:

* Cannot stand for any type of health of orthopedic reasons
* Do not work fulltime
* Pregnant at baseline or become pregnant during the study
A Study to Investigate RO7200220 as Monotherapy and in Combination With Ranibizumab in Participants With Diabetic and Uveitic Macular Edema

The purpose of this study was to assess the safety and tolerability of RO7200220 as monotherapy (diabetic macular edema \[DME\] or uveitic macular edema \[UME\] population) and in combination with ranibizumab (DME population only).


Eligibility Criteria:
Inclusion Criteria:

DME Participants:

* Diagnosis of Diabetes Mellitus (DM) (Type 1 or Type 2), as defined by the World Health Organization and/or American Diabetes Association
* Macular edema associated with DR defined as macular thickening by spectral domain optical coherence tomography (SD-OCT) involving the center of the macula: central subfield thickness (CST) of ≥325 μm with Spectralis.
* Decreased visual acuity (VA) attributable primarily to DME, with BCVA letter score of 73 to 19 letters (both inclusive) on Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts (20/40 -20/400 Snellen equivalent).
* Clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis.

UME Participants:

* Diagnosis of noninfectious uveitis (NIU) of any anatomical type (anterior, intermediate, posterior, panuveitis). Active and inactive NIU is allowed.
* Macular edema associated with NIU defined as macular thickening by SD-OCT involving the center of the macula: CST of ≥325 μm with Spectralis.
* Decreased VA attributable primarily to UME, with BCVA letter score of 78 to 19 letters (both inclusive) on ETDRS-like charts (20/32 - 20/400 Snellen equivalent).
* Sufficiently clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis.
* Either treatment naive or previously treated in the study eye or systematically (with washout periods and maximum doses applicable for specific treatments).

Exclusion Criteria:

* Any major illness or major surgical procedure within 1 month prior to Day 1
* Any febrile illness within 1 week prior to screening or Day 1
* Any stroke or myocardial infarction within 12 months prior to Day 1
* Any active proliferative DR (DME participants only)
* Panretinal photocoagulation or macular laser photocoagulation treatment prior to Day 1
* History of vitreoretinal surgery/pars plana vitrectomy
* Any cataract surgery within 3 months prior to Day 1 or any planned surgery during the study
* History of any glaucoma surgery including laser glaucoma procedures
* Uncontrolled glaucoma
* History of rubeosis iridis
* Any active ocular or periocular infection on Day 1
* Any presence of active intraocular inflammation on Day 1 or any history of intraocular inflammation (DME participants only)
* Any prior or concomitant periocular or IVT corticosteroids in the study eye (DME treatment naive participants only)
* Use of any systemic corticosteroids within 1 month prior to Day 1 (stable oral prednisone for UME participants allowed)
* Any prior or concomitant systemic anti-VEGF treatment within 6 months prior to Day 1
* Any concurrent use of biologics for immune-related diseases