cyrilzakka/clinical-trials huggingface dataset:
Effects of Preanesthetic Forced Air Warming and Administration of Warmed Intravascular Fluid

The majority of women (\> 60%) developed hypothermia and shivering during cesarean delivery. Core hypothermia may be associated with a number of adverse outcomes in patients, including shivering, wound infection, coagulopathy, increased blood loss and transfusion requirements, decreased metabolism and prolonged recovery. Shivering can result in interference with monitoring, increased tension on wound edges, and increased oxygen consumption.

A previous study has shown several modalities to prevent hypothermia and shivering in patients undergoing cesarean delivery with spinal anesthesia. But, single modality intervention have shown marginal or no efficacy.

Neuraxial anesthesia reduces the threshold for vasoconstriction and shivering. It often also produces a lower body sympathectomy that provokes a core to peripheral redistribution of body heat. It is difficult to treat the core to peripheral redistribution of body heat. However redistribution can be prevented by preanesthetic cutaneous warming. Prewarming hardly changes core temperature that remains well regulated, but it markedly increases peripheral tissue heat content. As a result, prewarming reduces the core to peripheral tissue temperature gradient and the propensity for redistribution after the induction of anesthesia.

We therefore hypothesized that Combined modality active warming consisting of preoperative 15 min of surface warming using a forced air warmer before spinal anesthesia and coloading of warmed intravenous fluid might reduce perioperative hypothermia and shivering in women undergoing cesarean delivery. Additionally, We tested the hypothesis that maintaining maternal normothermia increases newborn temperature and Apgar scores.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for cesarean delivery under spinal anesthesia
* The American Society of Anesthesiologists physical status class one or two
* female between 20 and 45

Exclusion Criteria:

* Patients with heart disease
* Patients with infectious disease
* Patients with coagulopathy
* Patients with a drug allergy
* In case of switching to general anesthesia
* Patients BMI under 18.5 or over 31
Investigation of a Supporting Ostomy Product Intended for Leakage Detection

People with intestinal stomas (especially an ileostomy) can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively.

To overcome this, Coloplast has developed a new supporting ostomy product, which has an adhesive sensor layer that should be place underneath the baseplate normally used by the subject.

Single arm design. Open-labelled Study duration: 21 days + 3 days.

Test product is a Digital Leakage Notification System. It consist of a sensor layer (worn beneath the baseplate), a transmitter attached to the sensor layer, a charger for charging of transmitter and an app, to be installed on a smartphone, which notifies the user of the status of their baseplate such as everything looks okay or there is a possible leakage.

Subjects are asked to use test product for 21 days. n=15 were using a phone with Android operating system and n=10 a phone with iOS operating system.

Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had a stoma for more than three months
4. Have intact skin on the area used in the evaluation meaning no broken skin and only minor discoloration of the skin (assessed by investigator)
5. Be able to use one of the five sensor layer sizes (i.e. Ø40, Ø50, Ø60, Ø70, Ø80 mm)
6. Ileo- or colostomists with liquid output (Bristol scale type 6-7).
7. Currently using a Coloplast product (1pc/2pc Flat/Convex/Concave) from e.g Assura/SenSura/SenSura Mio
8. Have self-reported problems with leakage\* (three times within 14 days)
9. Have worry of leakage 'to some, high or very high degree'
10. Is familiar with the use of a smartphone \*Leakage: Leakage is defined as output from the stoma on the backside of the baseplate (underneath the baseplate)

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Participating in other interventional clinical investigations or have previously participated in this investigation. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this protocol.
5. Known sensitivity towards test product
6. Known sensitivity towards acrylate
7. Is using/have a pacemaker
8. Is using ostomy paste or ostomy powder
Knot Burial Technique for Rectus Sheath Closure

Caesarean section is one of the most commonly performed abdominal operations on women in most countries of the world. Its rate has increased markedly in recent years, and is about 20-25% of all child-births in most developed countries.

The present study was a step to reduce postoperative pain in cesarean sections. Because of the large number of women that undergo caesarean section, even small differences in post-operative morbidity rates due to different techniques could translate into improved health and significant savings of cost and health services resources.

Closing the rectus sheath in cesarean sections with the knots pricking through the skin causes significant postoperative pain, discomfort and delayed ambulation. No comments in literature regarding the best way for closing the rectus sheath in cesarean sections.

AIM/ OBJECTIVES The aim of this study is to assess the efficacy of burying knots beneath the rectus sheath during cesarean section in reducing post operative pain and discomfort.

Study hypothesis:

In women undergoing cesarean sections may or may not burying knots beneath the rectus sheath reduce the post operative pain and discomfort.

Non absorbable and delayed absorbable monofilament materials require meticulous care to prevent knot slippage.

One common problem that arises from use of these materials is the discomfort caused by the knot pricking through the skin. Although this is a common problem after cesarean section, it is often overlooked and only very few preventive techniques have been described.

This study is to assess the efficacy of burying knots beneath the rectus sheath during cesarean sections in reducing post operative pain and discomfort.

Type of Study : A randomized controlled clinical trial. Study Setting :this study will be conducted at the department of Obstetrics and Gynecology at Ain-Shams University Maternity hospital.

Study time: 2019. Study Population : The study population comprises pregnant women, fulfilling the inclusion criteria, attending to Ain Shams University Maternity Hospital, during the study period, who are planned for cesarean delivery.

Eligibility Criteria:
Inclusion Criteria:

* Term pregnancy ( more than 37 weeks of gestation ) candidate for transverse incision elective cesarean delivery

Exclusion Criteria:

* patient with BMI \>30 and fat thickness \>3 cm.
* patient with haemoglobin less than 10g/dL
* patient with previous history of septic wound.
* Emergency lower segment cesarean section.
* Patients complaining of premature rupture of membrane.
* Patients need intra abdominal drains post cesarean sections
* Patients with established or gestational diabetes, coagulation defects, hemodynamic instability, septicemia or chorioamnionitis.
Role of Three Dimensional Ultrasound in the Diagnosis of Septate Uterus

Congenital uterine anomalies are found in 8% of infertile women and 24.5% of infertile women with a history of recurrent miscarriage, with septate and sub-septate uterus being the most common anomalies in these women, Also, septate uterus is the commonest anomaly found in infertile women requiring assisted reproductive technology.

Published data showed improved Cumulative pregnancy rate and live birth rate, and a significant reduction in Miscarriage rate in In Vitro Fertilization women after hysteroscopic metroplasty of both small and large septate compared to non-operated women.

Investigators hypothesized that trans-vaginal three Dimensional Ultrasound will be superior to Hystro-salpingography for the differentiation between arcuate and septate uterus in infertile women scheduled for In Vitro Fertilization.


Eligibility Criteria:
Inclusion Criteria:

* women with primary infertility,
* an indication for IVF and
* Suspected arcuate or septate uterus diagnosis based on hysterosalpingography .

Exclusion Criteria:

* were confirmed uterine abnormality by prior office hysteroscopy
to Evaluate the Preliminary Efficacy and Safety of GR1501 Injection in Patients With Active Axial Spondyloarthritis

Dosage: 100mg or 200mg or 300mg Administration frequency: Q2W administration in the first 4 weeks (W0, W2, W4), and subsequent Q4W administration (W8, W12) Administration: subcutaneous injection Specifications: 100mg/ 1mL/bottle or placebo 0mg/1ml/ bottle

This is a randomized, double-blind, placebo-controlled phase II clinical trial evaluating the preliminary efficacy, safety, pharmacokinetic, and immunogenicity of GR1501 injection (IL-17A antiboby) at different doses and dosing frequency in patients with active axial spinal arthritis.

A total of 160 patients were enrolled in the planned trial, and after passing the screening period of 2 weeks, they were randomly assigned to the 100mg group, 200mg group, 300mg group or placebo group according to 1:1:1:1.After the completion of the 16-week administration period, the follow-up period (\~24 weeks) was initiated.

Eligibility Criteria:
Inclusion Criteria:

1. According with the diagnosis of axial spondyloarthritis (axSpA) by the Assessment of Spondyloarthritis International Society (ASAS);,
2. During the screening period, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4 points and the Spinal Pain (BASDAI Article 2) NRS score ≥ 4 points;

Exclusion Criteria:

1. Previous or current Crohn's disease;
2. Suffering from ulcerative enteritis and requiring immunosuppressive therapy at present;
Pirfenidone as Treatment of Skin Fibrosis in Systemic Sclerosis

This study is to evaluate the efficacy and safety of an antifibrotic agent, pirfenidone as treatment of systemic sclerosis. The primary outcome of this study is improvement of skin fibrosis.

All patients enrolled should suffer from moderate to severe skin fibrosis at the screening stage.

The study period is 52 week. The study contains two stages, a 24-week blind stage following with open stage for another 24-week period of time. Subjects will receive pirfenidone or placebo randomized in the first 24-week and will all receive pirfenidone treatment in the second 24-week, with of combination of low dose steroids.

The secondary outcomes of this study include but not limit to safety, improvement of lung fibrosis and digital ulcer burden.

Eligibility Criteria:
Inclusion Criteria:

* Fulfill EULAR/ACR classification criteria (2013) for systemic sclerosis (SSc).
* Subjects must have mRSS≥10 at screening stage
* Subjects must have signs of fibrosis in their chest CT at screening stage
* If a subject has received treatments before, it should be stable at least 3 months until screening and with no significant efficacy (ΔmRSS≤-2)

Exclusion Criteria:

* Subjects with other connective tissue diseases overlapping with SSc
* Subjects with skin atrophy as the main cutaneous manifestation
* Subjects with active digital ulcers or gangrene
* Active severe SSc-driven renal disease or heart dysfunction at screening
* Subjects with significant hematologic abnormalities
* Abnormal liver function test at screening (ALT, AST or total bilirubin over 2 fold of upper normal level
* Clinically significant active infection including ongoing and chronic infections
* History of human immunodeficiency virus (HIV)
* Confirmed Positive tests for hepatitis B or positive test for hepatitis C
* Active tuberculosis
* Live or attenuated vaccine within 4 weeks prior to screening
* Subjects with significant hematologic abnormalities
Safety Validation of EndoSWIR Device

Head and neck cancer has an incidence of 600,000 cases per year worldwide (6th among cancers) and cause 380,000 death per year. Surgical resection is guided by the surgeon's inspection and palpation of the tumor. The prognosis of patients depends on the quality of the lesion's resection. The ENDOSWIR dispositive developed by engineers of Atomic Energy Comity of Grenoble allows for reliable and accurate analysis of tumor margins.

The camera provides a spectral analysis of the tissues according to their composition. We want to show that the prognosis of patients is improved by the use of this device. For that we need to prove first that it is not toxic for tissue analysis.

ENDOSWIR dispositive is a InGaAs (Indium Gallium Arsenide) camera working at ambient temperature. The light is a quartz-tungstene-halogeno (QTH) source and the collected beam is filtered to illuminate in different precise wavelength bands in the short wave domain.

We will use it on tonsil tissue just after tonsillectomy and just before the histological analysis.

Eligibility Criteria:
Inclusion Criteria:

* Tonsillectomy

Exclusion Criteria:

* suspicion of Head-and neck cancer
Bronchospasm During Anesthetic Induction: Study of Clinical Characteristics and Treatments Administered According to Etiology

Bronchospasm during anaesthesia is a rare but potentially life-threatening event. They are classically part of IgE-dependent anaphylaxis but can also occur as an independent clinical entity, triggered by inflammatory factors such as smoking, chronic bronchitis, asthma, overweight and mechanical factors such as tracheal intubation.

The etiological diagnosis is currently established during an allergy-anaesthesia consultation after skin testing for drugs used for induction of anaesthesia and antibiotic therapy when it is attributable.

The aim of this study was to determine the characteristics that differ between 2 groups: isolated non-allergic bronchospasm and bronchospasm as part of an immediate allergic hypersensitivity reaction.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred to the allergy consultation for investigation of an immediate hypersensitivity reaction, involving a bronchospasm explicitly identified by the anaesthetist, which occurred during an anaesthetic procedure.

Exclusion Criteria:

* None
Safety and Immune Response Study of an Investigational Pneumococcal Vaccine.

The purpose of this study is to evaluate the safety and immunogenicity of two doses of GSK Biologicals' 11 PCV vaccine when given to healthy subjects aged 18 to 40 years .

The study is open and subjects will receive two vaccine doses of GSK Biologicals' 11 PCV vaccine. Five blood samples will be taken: prior to and one month after each vaccine dose, and 2 weeks after dose 2.

Eligibility Criteria:
Inclusion Criteria:

* healthy male or female between 18 and 40 years of age
* 23-valent pneumococcal polysaccharide vaccine naive adults.

Exclusion Criteria:

* Previous vaccination against Streptococcus pneumoniae.
* History of pneumonia within 3 years prior to the first vaccination
* Any confirmed or suspected immunosuppressive or immunodeficient condition
* All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
* Subjects with documented anaemia or iron-deficiency (Hemoglobin level more than 10% below lower limit of normal)
* History of administration of an experimental/licensed vaccine containing similar adjuvants.
* History of chronic alcohol consumption and/or drug abuse.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
Impact of Free Mobility on FDG Uptake in PET Scans

Positron Emission Tomography (PET) is a rather long examination (around 2 hours), involving an injection of 18F-Fluorodeoxyglucose (FDG), which requires the patient to rest for 1 hour between the injection and the start of imaging. Some hospitals allow the patient to sit, read or use the telephone, but none allow the patient to move freely after injection, hence the interest of this work. The aim of this study is to demonstrate that free mobilization of the patient following 18F-FDG injection does not result in any significant difference in imaging quality (particularly muscular fixations), and therefore a medical interpretation identical to that of a patient who remains at rest.

FDG-PET is a fairly long scan involving an injection of 18F-FDG. Because of the fear of muscular fixations, the guidelines recommend for rest between injection and image acquisition. Indeed, some studies have demonstrated significant muscular uptake of the radiopharmaceutical in the event of major muscular effort prior to the examination. However, to investigators knowledge, the effect of free mobilization between injection and scan has not been evaluated. The aim of this study is to demonstrate that free mobilization of the participant after 18F-FDG injection does not result in a significant difference in imaging quality (especially muscular fixation) and therefore in a medical interpretation identical to that of a patient who remains at rest. Investigators also want to assess the impact on participant comfort and stress.

Each participant will receive an information leaflet with his or her examination appointment. On arrival in the department, after the study has been explained by the investigator and the participant has had all his questions answered, participant may accept inclusion by signing a consent form or refuse it. Once the inclusion of the participant has been validated, the randomisation will be done: the control group will benefit from the standard examination procedure (rest after FDG injection) and the experimental group will benefit from the study procedure (free mobility after FDG injection). The participant will complete a questionnaire on level of stress and comfort after the imaging procedure, and the nuclear physician will provide a blind interpretation.

A review of all blinded examinations will be carried out by two nuclear physicians to establish an examination quality score.

An intermediate analysis will be carried out when 50% of exclusions have been reached to stop the study if the management studied is detrimental compared with standard management.

Eligibility Criteria:
Inclusion Criteria:

1. Adults
2. Patient referred for FDG PET (excluding brain PET) and carried out on an outpatient basis.

Exclusion Criteria:

1. Bedridden patients
2. Protected person (under guardianship or curatorship)
3. Persons under court protection
4. Persons deprived of liberty
5. Persons not affiliated to a social security scheme
6. Pregnant or breast-feeding woman
Effects of Animal-assisted Therapy on the Physical Function and Communication of Adults With Autism

The aim is to evaluate the effects of a dog-assisted therapy program on physical function and communication in a sample comprised of 24 adults with autism spectrum disorder. The sample will be divided into 2 groups, a control group and an experimental group. Changes after 10 weeks (20 sessions) will be compared between-groups.

The intervention program will consist of 20 sessions conducted twice a week in the facilities of the collaborator associations. Each session will be conducted in groups of 3 participants and will last 30 minutes. It will include a welcome part, a main part (based on different activities and physical exercises with the dog) and a closing part to say goodbye to the dogs.

Physical function measures will be conducted before and after the completion of the study. The interaction and communication will be assessed during the sessions in the first, tenth and last ones.

Eligibility Criteria:
Inclusion Criteria:

* Older than 40 years
* With autism spectrum disorder
* Able to walk autonomously, without help from other people.
* Able to climb and descent stairs autonomously, without help from other people.

Exclusion Criteria:

* Medical condition that contraindicates the proximity or contact with the animals with the animals on the part of the user.
* Allergy to dog epithelium.
* Phobias to dogs.
* History of aggression to animals.
* Users who do not submit a signed informed consent form.
Celecoxib Japan Observational Study for the Patients With Acute Pain

This study is to assess the safety and efficacy of celecoxib on the pain relief from acute pain.

Patients with traumatic pain, post-surgical and tooth extract pain will be included in this study. Patients will receive Celecoxib for 2 weeks and the efficacy on pain relief and the safety will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with traumatic pain, post-surgical pain and tooth extract pain

Exclusion Criteria:

* Hyperreactive to sulfonamide
* Aspirin asthma patients
* Peptidic ulcer patients
* Serious liver disease patients
* Serious kidney disease patients
* Serious heart failure patients
* End of pregnancy
Evaluation of Botulinum Toxin A Alone Versus Botulinum Toxin A With Hydrodistension for Treatment of Overactive Bladder

The specific aim of this trial is to determine if hydrodistention at the time of intradetrusor injection of botulinum toxin A has additional benefit in patients with refractory overactive bladder (OAB) and urgency symptoms compared to intradetrusor injection of botulinum toxin A alone.

Consented patients will be randomized to hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A (hydrodistention group) or intradetrusor injection of 100 units of botulinum toxin A alone (botulinum toxin A alone group).

The primary aim will be subjective improvement measured as change from baseline at 12 weeks using the OAB-q bother subscale.


Eligibility Criteria:
Inclusion Criteria:

* Women with refractory overactive bladder symptoms, failing a credible behavioral therapy intervention and medical therapy or not tolerating medical therapy. Patients who are on medical therapy will stop the medical therapy for at least 2 weeks prior to botulinum toxin A treatment in the study
* Female ≥ 18 years old
* Desires further treatment for OAB symptoms.
* Express understanding and ability to perform clean intermittent self-catheterization (CISC) if required.
* Ability to consent
* Ability to complete all study related items and interviews

Exclusion Criteria:

* Post void residual urine volume \> 150 mL as assessed by catheter or ultrasound
* History of intradetrusor botulinum toxin A injection
* History of or current cancer of the genitourinary or gynecology tract
* Neurogenic bladder
* Interstitial cystitis
* Current urinary tract infection (can be treated and re-considered for study)
* Current active sacral neuromodulation device
* Non-English speaking
* History of chronic pelvic pain
* Hematuria not previously evaluated