cyrilzakka/clinical-trials huggingface dataset:
Reduction of Pre-operative Anxiety Using a Specially Designed Educational Program for Breast Cancer Patients Undergoing Surgery: a Randomized Controlled Trial

This study aims to find out that if a specially designed educational program can help in reduction of pre-operative anxiety in breast cancer patients undergoing surgery as a part of their treatment.

Anxiety can be defined as an unpleasant subjective experience associated with the perception of real threat; therefore, it is a common symptom in connection with cancer. Breast Cancer patients undergo surgery at some stage of their treatment, Surgery details can be overwhelming and might lead to low retention of information and greater levels of anxiety which is the most prevalent psychological symptoms perceived by cancer patients.

Studies have shown women with a diagnosis of cancer correlate with higher levels of preoperative anxiety. Increased anxiety elicits physiologic stress responses that may impede healing and alter responses to postoperative pain.It can also lead to delayed recovery, prolonged hospital stay and increased need of postoperative pain medications.

Pre-Operative Anxiety may also cause delayed recovery from Anesthesia and can also compromise the effectiveness of anesthesia .Furthermore, it can lead to other post-operative complications such as nausea, vomiting, and delayed wound healing. Various Pharmacological and non-pharmacological methods have been used for reduction of pre-operative anxiety and one such non-pharmacological method is educating the patients about the experience of surgery pre-operatively which we aim to study in our population.

Eligibility Criteria:
Inclusion Criteria:

1. 18 to 70 years of age.
2. Known cases of Breast Cancer.
3. Undergoing Breast Surgery as a part of treatment.
4. Availability of Personal smart phone at home.
5. Written informed Consent given for participation in trial.
6. Females.

Exclusion Criteria:

1. Less than 18 years or more than 70 years of age.
2. Stage IV patients undergoing palliative breast surgery.
3. Patient having chronic pain.
4. Un-availability of smart phone.
5. Patients with known psychiatric/depression disorders.
6. Previous history of another treated carcinoma.
7. Patients with re-current breast carcinoma.
8. Male Patients are excluded from study.
Estimation of Vitamin A Stores in Children and Women in Guatemala and Relation With Potential Toxicity Markers

The goal of this study is to assess whether 3-5 years-old children who have Vitamin A intakes above the tolerable upper intake level (UL=900 ug per day) have higher total body Vitamin A stores and biomarkers of excessive vitamin A status, compared to children with Normal Vitamin A intakes (250-600 ug per day).

The goal of this study is to assess whether VA intakes above the tolerable upper intake level (UL) and exposure to multiple programs are associated with are associated with 1) exposure to multiple VA intervention programs, and 2) elevated liver vitamin A concentration and biomarkers of excess vitamin A. Guatemala was selected as a study site because the country has a long standing national fortification program for vitamin A in sugar (law since 1975, re-launched and maintained since the 90´s). Typically, fortified sugar is used in more than 90% of households at average concentrations of 9 to 10 µg/g of sugar. VA fortified foods, in the form of fortified sugar, foods prepared with fortified sugar and other fortified foods, reach children from 2 years old to adulthood. On the other hand, high dose VA supplements, provided by local health services, only reached 10.5% of children ages 6-59 month in 2013. Children ages 2-3 and 4-5 years old with VA intakes above and below the UL will be recruited together with their mothers to assess the cumulative effect of fortification on young children and their mothers. Data from Program of Food and Nutrition Security (PROSAN), of the Ministry of Health, Guatemala in 2013, shows that coverage in the 30 Health Areas of the country is 17.9%, the lowest is 4.4% (San Marcos) and the largest 33% (Petén). Four of the 30 Region Areas correspond to the Department of Guatemala, in which urban and peri-urban areas of Guatemala City are included. In Central and North-West Guatemala Areas, coverage is 23 and 22% respectively, both above national average coverage and within the 10 out of 30 top coverages. According to PROSAN data for Micronutrient Powders in 2013, all four regions North-East, North-West, South, and Central Guatemala areas are also around or above the national coverage (14%) with 21.8, 11.2, 17.3 and 13.8% coverage. Another advantage of remaining in the 4 areas of Health around Guatemala city is that the four combined amount for 300,000 children of 0-59 month-old, that is more than 15% of the national children population reported. Even if coverages are low, population density will easier children recruitment.

Eligibility Criteria:
Inclusion Criteria:

* Children 3-5 years old and their mothers
* Child VA intake must be above 250 micrograms/day
* Children must be apparently healthy, Hemoglobin\>9 g/dL at recruitment point, C-reactive protein\<5 mg/L. For Women, Hemoglobin\>10 g/dL, C-reactive protein\<5 mg/L

Exclusion Criteria:

°Children with Congenital or chronical diseases, reported illnesses 1 week before the test. For Women: Pregnancy or lactation, Previously known Chronic Diseases
Better Adherence With New Oral Anticoagulant in Atrial Fibrillation : Effectiveness of a Personalized Education Program

This study is multicentric, single-blind, and interventional with a randomization into two parallel arm, between a standard of care information and an additional information of the patient, with a 12 month follow up.

The aim of this study is to evaluate the effectiveness of a personalized information program versus information provided from standard of care in patients taking Xarelto for Stroke Prevention in Atrial Fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* All patients treated with rivaroxaban chronically, (atrial fibrillation non-valvular under current AMM) for less than one year whatever anti vitamin K treatment history
* Affiliate or beneficiary of a social security system.
* Patient who formulated its "does not oppose" to participate in this research
* Age higher than or equal to 18 years

Exclusion Criteria:

* Opposition to participation
* Patient don't understand french language
* Patient does not have responsibility for the management of treatment (treatment administered by a nurse at home, or by caregivers)
* Tutorship or curatoship
* Law-protected patient
* Pregnant women or breast-feeding
Spironolactone Plus Metformin in Polycystic Ovary Syndrome

The investigators examined whether a combined therapy with low-dose spironolactone plus metformin is more effective than metformin alone in 52 overweight/obese Polycystic Ovary Syndrome (PCOS) patients.

In the present prospective, randomized study, we evaluated the efficacy of a combined therapy with metformin and low-dose spironolactone as compared to metformin alone on the clinical and endocrine-metabolic alterations of PCOS patients.

Eligibility Criteria:
Inclusion Criteria:

* Overweight/obese patients with PCOS

Exclusion Criteria:

* Other causes of hyperandrogenism and
* Use of drugs including:

  * oral contraceptive
  * anti-hypertensive agents
  * anti-diabetic drugs
  * agents for weight loss
Transverse Maxillary Expansion With a Segmental Le Fort I Osteotomy or Surgically Assisted Rapid Maxillary Expansion (SARME)

To assess transverse dental and skeletal expansion and stability after SLFIO with no fixation of the palatal vault compared to stabilization of the palatal vault with an autogenous bone block graft or fixation of the palatal osteotomy site with a biodegradable plate.

To assess transverse maxillary dental and skeletal expansion and stability after SARME with a TB distraction appliance compared to a BB distraction appliance.

Background: Surgical correction of transverse maxillary hypoplasia, in adolescents and adults is considered the least stable orthognathic procedure. Different surgical techniques have been advocated to improve the transverse stability. However, the pattern of transverse dental and skeletal expansion and long-term stability after segmental Le Fort I osteotomy (SLFIO) and surgically assisted rapid maxillary expansion (SARME) have never been compared systematically with different fixation techniques or distraction appliances.

Purpose: Test the H0-hypothesis of no difference in transverse stability after SLFIO without fixation of the palatal vault compared to stabilizing with either a bone block graft or a biodegradable plate. Moreover, test the H0-hypothesis of no difference in transverse maxillary dental and skeletal expansion and stability after SARME with either a tooth-borne (TB) or a bone-borne (BB) distraction appliance.

Method: 60 patients scheduled for SLFIO are included in a randomized clinical trial and allocated into 3 groups; I) stabilization of the palatal vault with a bone block graft, II) fixation of the palatal vault with a biodegradable plate and III) no fixation of the palatal vault. Moreover, 30 patients undergoing SARME are randomly allocated to either a TB or a BB distraction appliance. Transverse expansion and stability is assessed by clinical and radiographic measurements evaluating differences between dental and skeletal expansion, the pattern of skeletal expansion and the long-term stability.

Primary impact goal: Long-term transverse maxillary stability after SLFIO and SARME.

Eligibility Criteria:
Inclusion Criteria:

Mature non-syndromic patients scheduled for transverse expansion of the maxilla

Exclusion Criteria:

Previous orthognathic surgery involving the maxilla Congenital maxillofacial deformities
The Influences of Long Periods of Pneumoperitoneum and Head up Position on the Variation of Heart-rate Corrected QT Interval During Robotic-assisted Laparoscopic Gastrectomy - Observational Study

Sympathetic activity could be increased during robot-assisted laparoscopic gastrectomy, which is performed in a head up position under CO2 pneumoperitoneum.

Stimulation of the sympathetic nervous system prolongs the QT interval and can increases the susceptibility to life threatening cardiac arrhythmias.

Thus the investigators decided to evaluate the heart-rate corrected QT interval (QTc interval) during robotic-assisted laparoscopic gastrectomy.


Eligibility Criteria:
Inclusion Criteria:

1. ASA class I-II
2. obtaining written informed consent from the patients who were undergoing robot- assisted laparoscopic gastrectomy.

Exclusion Criteria:

1. emergency operation
2. cardiac disease (unstable angina, congestive heart failure, valvular heart disease)
3. ventricular conduction abnormality
4. prior pacemaker insertion
5. abnormal electrolyte values
6. patients who take antiarrythmic agent
7. hepatic or renal failure
8. drug hyperactivity
9. neurological or psychiatric illnesses
Effect of Low Glycaemic Index Diet on Blood Glucose Control in Chinese Type 2 Diabetic Patients

The purpose of this study is to investigate the effect of low glycaemic diet on blood glucose control in Chinese type 2 diabetic patients.

Glycaemic index (GI) is the measurement of post-meal blood glucose rise cause by ingestion of carbohydrate. For the same amount of carbohydrate, food with lower GI value cause a lower post- meal rise in blood glucose concentration in both normal and diabetic patients. Meta-analysis of randomized controlled trial has showed that low GI diet can achieve an additional reduction of A1c by 0.4% when compare with usual diabetic diet. Furthermore, various diabetes associations have already endorsed the use of low GI diet in the management of diabetes.

Hong Kong Chinese obtain most of their carbohydrate intake through consumption of rice or rice related foods, which are considered as having high GI value. In addition, it has been demonstrated that Asian have higher post-prandial rise in blood glucose than Caucasian after consuming the same amount of carbohydrate. When the above two factors add together, we expect our local type 2 diabetic patients are suffering from significant post-prandial hyperglycaemia, which in turn translate into elevated 24-hour hyperglycaemia and A1c.

However, nearly all studies about glycaemic index and diabetes are conducted in Caucasian. It is unclear about the benefit in Chinese patients with type 2 diabetes who are currently having diet with high GI value.

We therefore hypothesized that low GI diet may improve blood glucose control in Chinese type 2 diabetic patients. To test this hypothesis, we plan to conduct this randomized controlled trial about low GI diet in Chinese diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

1. Chinese Type 2 diabetic patient.
2. Already performing self monitoring blood glucose ( SMBG ) with pre- and post-meal readings.
3. At least 50% of 2hr post-meal capillary blood glucose values are \> 9 mmol/L.
4. A1c between 7.0 to 8.0% within 2 weeks of randomization.
5. Next follow-up is scheduled to at least 12 weeks or more if currently follow-up in TWEH.
6. On stable dose of anti-diabetic drug in the preceding 10 weeks.
7. No change in anti-DM drug in the next 10 week.
8. At least 18 years old.
9. Can read and understand consent form written in Chinese.
10. Can give informed consent.

Exclusion Criteria:

1. Unexplained hypoglycaemia in last 4 weeks.
2. Using rapid onset insulin ( such as Humalog, Novorapid, Actrapid HM, Mixtard HM, Novomix and Humalog Mix ).
3. Using acarbose.
4. Anaemia.
5. Known thalassaemia.
6. Suspected or confirmed iron deficiency.
7. On warfarin.
8. Renal impairment with serum creatinine \> 150 umol/L
9. Active medical illness, such as hepatitis, malignancy, infection, inflammatory arthritis, etc.
10. Unable to follow low glycaemic index diet.
11. Currently participate in other study.
12. Mentally or cognitively disable.
13. Pregnant or lactating women.
14. Hospital Authority or TWEH staff.
Evaluation of Safety and Tolerability of ATB-320 in Participants With Progressive or Metastatic Solid Tumors

The purpose of this study is to evaluate the safety and tolerability of ATB-320 in patients with progressive or metastatic solid tumors

1. Primary objective: to evaluate the maximum tolerable dose (MTD), recommended phase 2 dose (RP2D), and dose limiting toxicities (DLTs) of ATB-320 in patients with progressive or metastatic solid tumors.
2. Secondary objective: to evaluate safety and tolerability of ATB-320 in patients with progressive or metastatic solid tumors.
3. Exploratory objective: to evaluate pharmacokinetics, pharmacodynamics, and efficacy of ATB-320 in patients with progressive or metastatic solid tumors.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (18 years or older) at the time of screening
2. Histologically confirmed solid tumor
3. Participants must have failed standard therapy or cannot tolerate standard therapy.
4. Participants must be able to provide tissue samples, either stored at the institution or obtained from a biopsy performed prior to administration of the investigational product, and have tumor that can be safely biopsied throughout the study.
5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
6. Life expectancy of ≥ 12 weeks

Exclusion Criteria:

1. Has received chemotherapy within 21 days prior to the first planned dose of the investigational product, or if less than 5 times the half-life of the chemotherapeutic has passed (whichever is shorter)
2. Has received immunotherapy within 2 weeks of the first planned dose of investigational product
3. Major surgery within 4 weeks prior to the first planned dose of the investigational product
4. Previous malignant tumors, other than the target indication to be investigated in this study, within 3 years prior to screening (participants with locally malignant tumors such as basal cell carcinoma/squamous cell carcinoma of the skin, carcinoma in situ (cervix, breast), thyroid papillary carcinoma that have undergone potentially curative therapy are eligible to participate in the study.
5. Current enrollment in any other clinical trial or has received another investigational product or medical device treatment within 28 days of first planned dose (participants who are undergoing safety follow-up phase of a clinical trial may participate if more than 28 days have passed since the last dose of the previous investigational product)
6. Has received prior radiotherapy within 2 weeks of the first planned dose. Participants who have received palliative radiotherapy for non-central nervous system (CNS) disease within 2 weeks of first planned dose are allowed to participate after 1-week washout (participants must have recovered from any radiation-related toxicities, not require corticosteroid treatment, and without radiation pneumonitis)
7. History of hypersensitivity to the active ingredients or excipients of the investigational product or other drugs
Head Positions to Open the Upper Airway

Ventilation during basic life support improves survival in cardiac arrest patients significantly. Unfortunately, this is in contrast to the willingness of potential rescuers to perform mouth-to-mouth ventilation. For example, although healthcare professionals would perform mouth-to-mouth ventilation on a 4-year old drowned child in \>90% of cases, this likelihood would decrease to \~10% in the case of a young male unconscious patient in a San Francisco public bus. Possibly, lay rescuers would perform assisted ventilation more often if a simple ventilation device were available. However, both the willingness to perform assisted ventilation plus the ability to open and to maintain the airway patent are necessary to ensure efficient ventilation in an unconscious patient with an unprotected upper airway.

Since retention of skills after basic life support classes are notoriously low, a resuscitation tool should incorporate self-explanatory features to improve applicability, and to provide built-in safety. Thus, an option could be to ensure an open airway by the use of a built-in indicator within a ventilating device to confirm correct head extension. One possible approach may be to determine head position angles that make an open airway likely, and integrate these angles into a scale on a ventilating device; however, safe head extension needs to be determined first to prevent harm.

The purpose of this study is to determine head position angles and ventilation parameters reflecting neutral position, maximal extension and a position deemed optimal by an anaesthesiologist in patients undergoing anaesthesia induction for elective surgery in a first step to design a ventilating device to optimise ventilation of an unprotected upper airway. The investigators will ventilate 30 patients with a pillow under the head simulating ventilation in the operating theater, and 30 patients without a pillow under the head simulating ventilation during cardiopulmonary resuscitation.

Dentures will not be removed during assessment. After anaesthesia induction the head will be consecutively flexed in the three positions and measurements performed. Afterwards, general anaesthesia and surgery will ensue. The health risk for this extra minutes of mask ventilation is minimal.

The null hypothesis is that there will be no differences in head position angles and ventilation parameters.


Eligibility Criteria:
Inclusion Criteria:

* ASA I and II

Exclusion Criteria:

* Cervical spine pathologies
* Peripheral nerve deficiencies
* Body mass index \>40kg/m2
* Obvious primary or secondary craniofacial abnormalities
Erectus Nerve Block for Lumbar Spine Surgery

: Spine surgery induced severe postoperative pain. Several techniques as intravenous multimodal analgesia have been proposed to reduce pain relief and morphine rescue over the first postoperative days. Regional anesthesia using the erectus nerve block is a simple infiltration across lamina of the vertebra: Ultrasound-guided posterior ramus of spinal nerve block for anesthesia and analgesia in lumbar spinal surgery This study compared erector nerve block with local anesthetic vs placebo to reduce pain and morphine rescue after lumbar spine surgery. The investigators hypothesized that eructor nerve block induced a large block from L1 to L5 that induced posterior nerve roots block anesthesia. This block reduced pain after surgery.


Eligibility Criteria:
Inclusion Criteria:

* age\> 18years and \<80 years
* lumbar spine surgery (2-4 levels)
* posterior approach
* ASA 1-3

Exclusion Criteria:

* refusal
* age \< 18yrs
* \<50 kg and \>120 kg
* pregnant
* renal or hepatic severe desease
* ASA 4
* no French speaking
* emergency surgery
* local or systemic infection
* surgical resumption of the surgical site
* surgery involving a thoracic approach
* allergy to local anesthetics
Viapaed Study In Children And Adolescents With Asthma

Asthmatic children who remain symptomatic on inhaled corticosteroids (ICS) require an adjustment of their asthma therapy. Current guidelines suggest that the treatment options are either an increased dose of inhaled corticosteroid or the addition of other therapy such as a long-acting beta-agonist (LABA). In the pediatric age range, major concerns with respect to high dose ICS therapy are growth retardation and the suppression of the hypothalamic-pituitary-adrenocortical (HPA) axis. Previous studies in adults have shown that a combination product that included a LABA as well as the ICS allowed to reduce the steroid dose and was still at least as effective in achieving asthma control as treatment with a higher dose of ICS. These treatment options shall be compared in the present study. Children who remain symptomatic while inhaling 100 µg fluticasone (FP) twice daily shall be randomized to receive the salmeterol/ fluticasone combination product, Viani (SERETIDE) 50/100 µg, or fluticasone 200 µg as a comparator drug, inhaled twice daily via the DISKUS for a period of eight weeks.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 4 to 16 years with an established history of perennial asthma.
* Subjects who are treated with an inhaled corticosteroid according to BDP (budesonide) 200-400 µg/day or equivalent during the last 4 weeks before run-in.
* 15 minutes after inhaling 200µg of salbutamol, reversible increase in FEV1 of at least 12% of the pre-dose value.
* Willingness to substitute previous controller medication on the twice daily inhalation of fluticasone 100µg bid via DISKUS®.
* Subjects/guardians who have given written informed consent to participate in the study.
* Subjects /guardians who are able to understand and complete a diary record card (DRC).
* Subjects who are able to use a Mini-Wright Peak Flow meter.
* Sexually active female adolescents must use adequate contraception.
* Willingness to refrain from any other controller medication (including anti-leukotrienes) or from regular use of short-acting beta agonists or anticholinergics during the treatment period.