cyrilzakka/clinical-trials huggingface dataset:
KIDSHEART AND BRAIN : Early EEG Surgery Congenital Heart Disease Predict Onset of Neurodevelopmental Disorders

Congenital cardiopathy are frequent malformations (1/100 birth). The progress of surgery permit a survival rate at the adult age of more than 90%. The long terms consequences must be taken in account and the nerodevelopmental disorders are in first place (intelectual deficiency, autism spectrum disorders, or attention disorders) and presents in 30 to 60% of the patients (Calmant, 2015). The impact can be important on the scolarity, the studies, the professional activity and finaly on the quality of life of the patients becomming adults.

The identification of the risk factors on surgery period should permit to propose the most adapted follow-up to the specifics needs of each patients.

On the scientific plans, the identification of early markers on brain dammage on EEG should permit to better apprehend the physiopathologic mecanisms involved.

Interest of early EEG on congenital cardiopathy surgery to predict the neurodevelopmental disorders occurence.

Congenital cardiopathy are frequent malformations (1/100 birth). The progress of surgery permit a survival rate at the adult age of more than 90%. The long terms consequences must be taken in account and the nerodevelopmental disorders are in first place (intelectual deficiency, autism spectrum disorders, or attention disorders) and presents in 30 to 60% of the patients (Calmant, 2015). The impact can be important on the scolarity, the studies, the professional activity and finaly on the quality of life of the patients becomming adults.

The identification of the risk factors on surgery period should permit to propose the most adapted follow-up to the specifics needs of each patients.

On the scientific plans, the identification of early markers on brain dammage on EEG should permit to better apprehend the physiopathologic mecanisms involved.

Eligibility Criteria:
Inclusion Criteria:

* Child of less than 1 year admitted for cardiac surgery on extracorporal circulation on the CHU of Lille during the study period.
* Child with congenital cardiopathy with necessity to be operated before 1 year old.

Exclusion Criteria:

* Child with no necessity of surgery before 1 year old.
* Medical history of cardiac surgery.
* Refusal of consent by the parents.
* No social security.
* Child not operated on the CHU of LILLE.
Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India

The study is a cluster-randomized, controlled trial conducted among 100 villages (including approximately 3500 households and 20,000 people) in Puri district, State of Orissa, India. The study aims to assess the impact of the construction and use of latrines in rural settings on diarrhoeal disease, helminth infections and nutritional status. The study will also report on the cost and cost-effectiveness of the intervention and its impact on lost days at school and work as well as on expenditures on drugs and medical treatment. The study will document how the intervention actually impacts exposure to human excreta along principal transmission pathways by evaluating the impact on (i) faecal contamination of drinking water, (ii) the presence of mechanical vectors (flies) in food preparation areas, and (iii) the presence of faeces in and around participating households and villages. The study will also explore the extent to which different levels of acquisition and use of on-site sanitation among householders impact disease throughout the community.


Eligibility Criteria:
Inclusion Criteria:

Village level:

* Little existing sanitation coverage (\<10%)
* WaterAid and implementing partners expects normal scale up
* Stable and reasonably acceptable water supply
* No other WASH interventions planned or anticipated in next 30 months
* Reasonable year-round access by road to permit household visits by surveillance staff

Household level:

* Presence of a child\<4 or a pregnant woman
* Consent to participate
* Reside permanently in the village
Prospective Study To Assess The Safety And Effectiveness Of Tixel Treatment On Dry Eye Symptoms In Asian Patients

Pilot study where effect of standard Tixel treatment as used for periorbital wrinkles would be assessed on Dry Eye Disease symptoms and signs in Asian Patients.

Safety Assessment will be asses via AE/SAE reporting and Impact Assessment of the effect of the treatment on dry eye symptoms and signs through multiple

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years.
2. OSDI score of at least 23.
3. Noninvasive Tear film break up time (NIKBUT) ≤ 10 seconds.
4. No other eye or skin or immune problems.
5. Willing and able to provide written informed consent.
6. Willing to participate in all study activities and follow study instructions.

Exclusion Criteria:

1. Pregnancy and/or breastfeeding.
2. Lesions in the periorbital area.
3. Acute severe blepharitis.
4. Acute conjunctivitis.
5. Concomitant anterior eye disease.
6. Has undergone outdoor/sunbed tanning during the last 4 weeks.
7. Is unwilling to follow the Tixel aftercare instructions after each of the three Tixel treatments.
8. Active Herpes Simplex or tendency for Herpes Simplex in the periorbital area (meaning the subject has had the condition previously).
9. Current skin cancer, malignant sites and/or advanced premalignant lesions or moles in the treatment area.
10. An impaired immune system condition or use of immunosuppressive medication.
11. Collagen disorders, keloid formation and/or abnormal wound healing.
12. Previous invasive/ablative procedures in the areas to be treated within 3 months prior to initial treatment or plans for such treatment during the course of the Tixel treatments, or before complete healing of the treatments has occurred.
13. Has taken any medications (including via topical application), herbal treatment (oral or topic), food supplements or vitamins, which may cause fragile skin or impaired skin healing during the last 3 months.
14. Has used oral Isotretinoin (Accutane® or Roaccutan®) within 3 months prior to treatment.
15. History of bleeding coagulopathies or use of anticoagulants.
16. Tattoos or permanent makeup in the areas to be treated.
17. Burned skin, blistered skin, irritated skin, or sensitive skin in any of the areas to be treated.
18. Thread lifting of the area to be treated in the last 3 months.
Transumbilical Laparoscopy-assisted Appendectomy

transumbilical laparoscopic-assisted appendectomy (TULAA) was reported that the operation time was shorter and the postoperative frequency of complications was not high compared to conventional laparoscopic appendectomy (CLA) with three conventional ports in retrospective studies. The purpose of this study is to evaluate the outcomes of transumbilical laparoscopic-assisted appendectomy (TULAA) and to compare them to the outcomes of CLA.

Single port appendectomy can be considered as the better option than conventional laparoscopic appendectomy (CLA) for pediatric patients with uncomplicated acute appendicitis in cosmetic aspect. However, this technique has not gained popularity because it has been regarded as a tricky and time-consuming procedure. Recently, the frequency of implementation of transumbilical laparoscopy-assisted appendectomy (TULAA) is increasing in pediatric patients with uncomplicated appendicitis. The reason that this operation is possible in children, is that the length between umbilicus and appendix is shorter than that of an adult, and the abdominal wall is flexible, so that the appendix can be extracted through umbilical incision. It was reported that the operation time was shorter and the postoperative frequency of complications was not high compared to the laparoscopic appendectomy with three conventional ports. The purpose of this study is to evaluate the outcomes of transumbilical laparoscopic-assisted appendectomy (TULAA) and to compare them to the outcomes of CLA.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically diagnosed as acute appendicitis
* Age 18 or under
* Lab tests Hemoglobin ≥ 10g/dl White blood cell count ≥ 4,000/mm3 Platelet count ≥ 100,000/mm3 Creatinine ≤ 1.5 mg/dl Aspartate aminotransferase ≤ 100 IU/L Alanine aminotransferase ≤ 100 IU/L
* no significant dysfunction in the heart, lungs, kidneys.

Exclusion Criteria:

* Previous abdominal operation
* Generalized peritonitis
* Anticipated extended resection
* Periappendiceal abscess on preoperative exam
Post-authorization Safety Study in Type 2 Diabetic Patients in Saudi Arabia Treated With Empagliflozin to Assess the Incidence of Ketoacidosis, Severe Complications of Urinary Tract Infection, Volume Depletion, and Dehydration

The objectives of this study are to assess the risk of ketoacidosis, severe urinary tract infections, volume depletion, and dehydration associated in patients with T2DM initiating Empagliflozin compared to patient initiating a dipeptidyl peptidase-4 (DPP-4) inhibitors over a 12-month period of follow-up, including the month of Ramadan


Eligibility Criteria:
Inclusion Criteria:

* Patients who have signed Informed consent form.
* The patients will be at least 18 years old at index date, diagnosed with Type 2 diabetes mellitus (T2DM) in Saudi Arabia, and who will initiate Empagliflozin or Dipeptidyl-peptidase 4 (DPP4) inhibitors treatment according to the local label and at the discretion of the treating physician during the study period, who have not used other sodium/glucose co-transporter 2 (SGLT2) or DPP4 inhibitors during the previous 12 months.

Exclusion Criteria:

* Known hypersensitivity to Empagliflozin, the comparator DPP-4 inhibitors or any of their excipients
* Patients for whom Empagliflozin or the comparator DPP-4 inhibitor is contraindicated according Saudi Food and Drug Authority (SFDA) approved label
* Patients prescribed fixed-dose combinations of SGLT2 inhibitors with DPP-4 inhibitors will be excluded.
* The same inclusion and exclusion criteria will be applied to the comparator group, which will include new users of DPP-4 inhibitors.
Study of the Response to a Neoadjuvant Chemotherapy Based on the Antitumor Immune Response in Localized Breast Cancer

This is a prospective, non-randomized study which aims to evaluate the response to a neoadjuvant chemotherapy according to the the antitumor immune response in localized breast cancer.

40 patients will be enrolled in the study. They will receive chemotherapy : 3 or 4 anthracycline cycles or 3 or 4 FEC-100 cycles followed by 3 or 4 taxane cycles.

Trastuzumab will be added to taxane for HER2+/Neu+ patients. Then, patients will be operated and receive an adjuvant treatment which will both depend on the investigator's appreciation.

Blood sample will be collected on the first day of the first chemotherapy cycle, on the first day of the third cycle, on surgery, 6 months after the surgery and in case of relapse.

Tumor sample will be collected on diagnosis as much as possible and on surgery.

Patients will be followed during 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven localized breast cancer required anthracycline chemotherapy +/- trastuzumab before surgery
* Age \> 18 years
* Chemotherapy with 3 anthracycline cycles to begin (doxorubicin or epirubicin)
* Any previous treatment for this cancer
* Performance Status \<= 1
* Agreement for the conservation of biological samples
* Covered by an medical insurance
* Signed written informed consent form
* Availability of tumoral sample collected at diagnosis

Exclusion Criteria:

* Previous surgery for the breast cancer
* Already under chemotherapy before the first blood sample
* Previous Antitumoral treatment
* Under immunosuppressive treatment
* Under corticoids during the 15 days before enrollment
* History of concomitant cancer except if it has been cured for at least 5 years
* History of lymphoma or breast sarcoma
* History of chronic inflammatory disease or autoimmune disease, hepatitis B or C or immune dysfunction disease (including HIV-positive stage AIDS) known
* History of other disease which is discrepant with this study
* Deprived of liberty by court or administrative decision
* Pregnant or breastfeeding women or with no use of effective birth control methods for women of childbearing potential
Monitoring Metered Dose Inhalation (MDI) Volume and Timing With a Respimetrix Device in Obstructive Lung Disease.

To Determine whether use of the Respimetrix flow test device a) can determine "good" versus "poor" inhaler techniques, and b) the effects of the inhaler training on technique.

Good metered dose inhaler (MDI) technique is described as sitting or standing upright with the head slightly tilted back, exhaling fully, and then inhaling slowly and deeply as you activate the MDI. Common mistakes include: not exhaling fully; not inhaling deeply enough; inhaling too quickly, and not activating the MDI at the proper time.

This study will use the Respimetrix device with placebo to assess a patient's inhaler technique, provide training to patients who demonstrate poor inhaler technique, and remotely track a subject's breathing ability over time.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Current diagnosis of asthma or Chronic obstructive pulmonary disease (COPD) patients
* Patients must be willing and able to provide informed consent to participate in the the study.
* Patients must be able to use a metered dose inhaler

Exclusion Criteria:

* Contraindication to inhaler use
* Tracheostomy
* Incapacitating disability that interferes with the use of the inhaler or execution of the protocol
* Unable to understand informed consent (e.g. non-English speakers)
Human Factors Study of Ultrasound Navigation Software for Cardiac Imaging

The Product is a machine learning software, that utilizes AI to provide real-time guidance to acquire diagnostic-quality ultrasound views of the heart.

Participants are healthcare professionals, who are not performing echocardiography on a routine basis. Participants attend a short training session to learn the software, then have a memory-decay period, followed by an individual simulated-use scanning session, lasting up to 60 minutes with a Moderator at the heart institute.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Novice users or medical professionals who do not perform echocardiographs as part of their routine job responsibilities.
* Have the capacity to understand study risks and consent to be in the study
* Be available and willing to participate in the study
* Not be employed by the Sponsor or another medical device or pharmaceutical company

Exclusion Criteria:

-
Evaluation of Accuvein in Adult Patients

The objective of this study is to evaluate the effectiveness of Accuvein to facilitate venous blood sampling and placement of peripheral intravenous catheters in adults. This clinical protocol is designed to determine whether using Accuvein increases the ease and efficiency of venous cannulation (as perceived by the operator), decreases the time to effective cannulation, decreases the number of sticks, and decreases the patient's perception of the pain.


Eligibility Criteria:
Inclusion Criteria:

* adults requiring a venous blood sampling or the placement of a venous peripheral catheter

Exclusion Criteria:

* none
A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid

The purpose of this study is to evaluate the safety of efgartigimod PH20 SC over a longer period of time in adult participants with moderate-to-severe bullous pemphigoid (BP) who have completed ARGX-113-2009 study. The study will also evaluate the efficacy of efgartigimod PH20 SC.

Eligible participants can roll over from the main study (ARGX-113-2009) to this open-label extension study (ARGX-113-2010). The study consists of a treatment period of up to 48 weeks in which participants receive efgartigimod PH20 SC. After the first 5 visits, the participants will visit the study centers at least once every 4 weeks. The participants who are not receiving efgartigimod PH20 SC (after the main study or currently on the study), will enter an observation period with study visits at least once every 8 weeks. If the participant relapses, they can re-enter the treatment period where they will receive efgartigimod PH20 SC. The treatment and observation period is followed by a follow-up period of 8 weeks. Oral or topical corticosterioids can be administered at the investigator's indiscretion


Eligibility Criteria:
Inclusion Criteria:

* Has completed the week 36 visit of ARGX-113-2009
* Is capable of providing signed informed consent and complying with protocol requirements
* Agrees to use contraceptive measures consistent with local regulations and the following: Women of childbearing potential must have a negative urine pregnancy test at baseline before receiving the study drug and must use one of the contraception methods described in the protocol from signing the ICF until the last dose of the study drug

Exclusion Criteria:

* Clinically significant disease, recent major surgery (within 3 months of baseline), or intends to have surgery during the study; or any other medical condition that, in the investigator's opinion would confound the results of the study or put the participant at undue risk
* Known hypersensitivity to the study drug or 1 of its excipients
* Permanently discontinued IMP in ARGX-113-2009 due to an adverse event (AE) considered related to the study drug and for whom the benefit/risk balance is not considered positive
A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma

A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma

This is a randomized, double-blind, placebo-controlled, multicenter, global Phase III study to determine the efficacy and safety of transarterial chemoembolization (TACE) treatment in combination with durvalumab monotherapy or TACE given with durvalumab plus bevacizumab therapy compared to TACE therapy alone in patients with locoregional hepatocellular carcinoma not amenable to curative therapy

Eligibility Criteria:
Key Inclusion Criteria:

* No evidence of extrahepatic disease
* Disease not amenable to curative surgery or transplantation or curative ablation but disease amenable to TACE
* Child-Pugh score class A to B7 and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
* Measurable disease by Modified Response Criteria in Solid Tumors (mRECIST) criteria
* Adequate organ and marrow function

Key Exclusion Criteria

* Any history of nephrotic or nephritic syndrome
* Clinically significant cardiovascular disease or history of arterioembolic event including a stroke or myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months prior to randomization
* Any prior or current evidence of coagulopathy or bleeding diathesis or patients who had any kind of surgery in the past 28 days (biopsies are exempt from this exclusion)
* History of abdominal fistula or GI perforation, non healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment
* Patients with Vp3 and Vp4 portal vein thrombosis on baseline imaging are excluded
Laughter Yoga on Blood Glucose Levels, Disease Perception and Perceived Stress Level

Aim This study was conducted to evaluate the effect of laughter yoga on blood glucose level, disease perception and perceived stress level in patients with Type 2 diabetes mellitus.

Method The study was conducted using a randomized controlled experimental design with a pre-test and post-test. The population of the study was followed up with the diagnosis of Type 2 diabetes mellitus (T2DM) in the endocrine outpatient clinics of a hospital in the western region of Turkey. The sample consisted of 100 patients (laughter yoga group=50, control group=50) determined by power analysis. Participants were assigned to each group through a process of simple randomization. Data collection was facilitated using a "Patient Identification Form,", "The Brief Disease Perception Scale," and " The Perceived Stress Scale".

During the research process, in the laughter yoga group participated in eight laughter yoga sessions. while the patients in the control group continued to receive routine care practices.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with T2DM for at least 6 months,
* Able to use computer and/or mobile applications,
* At least primary education graduate,
* Using oral antidiabetic drugs,
* No diagnosed psychiatric illness,
* No communication problems,
* Patients who volunteered to participate in the study were included.

Exclusion Criteria:

* Using Parenteral Insulin,
* The one who doesn't attend all the yoga sessions,
* Patients with physical conditions that prevent them from participating in laughter yoga sessions (respiratory distress, persistent cough, veritgo, severe heart disease, hemeroid, hernia of any kind, severe back pain, urinary incontinence, epilepsy, bleeding tendency, thrombocytopenia and deformity visible on examination),
* Patients taking medication or other nonpharmacological methods to reduce stress,
* Patients who did not want to participate in the study were excluded.