cyrilzakka/clinical-trials huggingface dataset:
Effects of Recruitment Maneuver During Intraoperative Period

The aim of this study is to observe the effect of respiratory recruitment maneuver on intraoperative ventilatory parameters and postoperative pulmonary complications in patients over 18 years scheduled for laparoscopic hysterectomy.

In patients over 18 years who are scheduled for laparoscopic hysterectomy volunteering to participate in our study will receive anesthesia induction with one of our standard general anesthesia protocols. After intubation recruitment maneuver will be applied to the study group. General anesthesia and mechanical ventilation will be continued and completed according to our standard practice without any further intervention. Throughout the intraoperative period respiratory and haemodynamic parameters including compliance, airway resistance, mean arterial pressure, heart rate, pulse oxymetry, blood gas analysis, the applied inhalational anesthetic agent, minimum alveolar concentration, expiratory agent concentration and total agent consumption will be recorded. At the end of the operation anesthesia will be terminated and patients will be transferred to postanesthesia care unit (recovery unit after recovery and further discharged from to the ward when their Aldrete score is \>8. The patients will be examined for respiratory complications on postoperative day 1, and will be followed up by telephone on day 5.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology (ASA) I-II
* \> 18 y
* laparoscopic hysterectomy patients

Exclusion Criteria:

* Patient refusal to participate in the study
* \<18 y, BMI\> 40
* Patients receiving invasive MV support in the last 1 month
* Patients who received chemotherapy or radiotherapy in the last 2 months
* Patients with severe pulmonary disease (COPD, asthma, pulm infection, bronchiectasis) (those who have previously received Non-Invasive MV, oxygen therapy or steroid therapy for an acute attack)
* Those with known severe pulmonary Hypertension
* Intracranial tm
* Hemodynamic instability
* Shock.
* Neuromuscular disease
Antidepressant Incomplete Response Depression

Observational, non-interventional, longitudinal, prospective,multicenter, open label (No treatment is involved). 3 assessment will be carried out . The 1st one will be on baseline, the 2sd one after a significant change in pharmacological treatment and 3rd one after a second significant change in pharmacological treatment. If there isn´t any significant change in therapeutic plan a control assessment will be carry out in week 10th and 24th. A significant treatment change is defined as a change in SSRI/SNRI, to add another SSRI/SNRI or a augmentation treatment added to SSRI/SNRI. The primary objective is to describe therapeutical strategies (antidepressant change, association with another antidepressant or association with another treatment) in the management of patients with MDD with incomplete response or intolerance to an antidepressant after a first or a second failure; and when the psychiatrist decide a change of strategy. Secondary objectives include: 1 - To describe the clinic profile of depressive patients with incomplete response or intolerance to an antidepressant after a first or a second failure; 2- To describe the profile of patients based on therapeutic strategies used and number of therapeutic strategies; 4- Evaluate the use of health resource due to lack of fast onset of action, and social cost (productivity, care givers...); 5 - To associate clinical variable with therapeutic action by psychiatrist.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written inform consent
* Diagnosed of Major Depressive Disorder based on DSM-IV-TR
* Outpatient who has a change in pharmacological therapeutic plan after an incomplete response or intolerance to a treatment with an adequate dosage of an antidepressant (SSRI/NSRI) 5
* Able to understand and to comply with requirements of the study

Exclusion Criteria:

* Mental retardation
* To have been recruited in a clinical trial in the last 4 weeks or to have planned the inclusion in a clinical trial during the follow-up of this study
* MDD secondary to substance abuse or somatic illness
* Actual depressive episode with \<4 weeks or \>12 months of length
* Current treatment with \>1 SSRI/SRNI or previous treatment with \>1 SSRI/SRNI, augmentation treatment with SSRI/SRNI, intravenous antidepressant treatment, TMS, ECT or MAO
The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Shoulder Arthroscopy

This study is designed to evaluate the effects of administering CBD to control post-operative pain in patients undergoing shoulder arthroscopy. Secondly, the purpose will be to evaluate the effectiveness of CBD in comparison with opioid therapy for post-operative pain.


Eligibility Criteria:
Inclusion Criteria

* Patients undergoing an arthroscopic shoulder procedure (rotator cuff repair, decompression, labrum repair)
* Patients ages 18-75, inclusive
* Female patients must be currently practicing effective forms of two types of birth control, which are defined as those, alone or in combination, that result in a low failure rate (less than 1% per year) when used consistently and correctly
* Male patients must be using an effective form of contraception

Exclusion Criteria

* Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
* Younger than 18 years of age
* Older than 75 years of age
* Any patient considered a vulnerable subject: pregnant women or fetuses, children, cognitively impaired adults, prisoners
* History of cannabis abuse or dependence
* History of coagulation abnormalities and thromboembolic disease or current abnormal coagulation test values
* History of stroke or acute coronary syndromes within 3 months before surgery
* Abnormal coagulation profile
* Renal failure (serum creatinine \> 250 μmol/L \[2.83 mg/dL\]) or liver cirrhosis
* Patients with a history of hypersensitivity to Percocet
* Patients that have been on pre-operative opioid management for any reason
* Patients meeting the DSM-V for major psychiatric illness, such as bipolar disorder
* Patients diagnosed with major depression, psychosis, or substance abuse disorder
* Patients with current or a history of suicidal ideation
* Breastfeeding females
* Patients with clinically significant illness, including cardiovascular disorders
* Clinically significant lab abnormalities
* Abnormal LFTs
* Patients with major neurological disorders, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, history of traumatic brain/head injury, or seizures
* Patients with moderate (Child-Pugh B) and severe hepatic impairment (Child-Pugh C).
* Patients taking moderate or strong inhibitors of CYP3A4 and CYP2C19 (listed below) concomitantly
* Patients taking strong CYP3A4 and CYP2C19 inducers (listed below) concomitantly
* Patients taking substrates of UTG1A9, UTGB17, CYP2A1, CYP2B6, CYP2C8, CYP2C9 and CYP2C19 (listed below) concomitantly
Vitamin D and Sleep Disorders in Pregnancy

Lack of sleep and poor sleep quality in pregnant women are associated with maternal depression and cognitive-sensual irregularities. These irregularities were reported worsening women's life quality and even increasing suicide ideation. It is also associated with obstetrical complications such as fetal growth deficiency, preterm birth, prolonged labor, preeclampsia and increased abdominal delivery frequency.Vitamin D also may affect the sleep indirectly through the cases with nonspecific pains. It was reported that vitamin D levels are correlated with sleep disorders such as obstructive sleep apnea and restless legs syndrome. The primary purpose of this study is to examine sleep disorders and vitamin D levels in pregnant women, and also, secondarily, vitamin D - anxiety and sleep disorders - anxiety relations were assessed.


Eligibility Criteria:
Inclusion Criteria:

* singletone pregnant women
* second and third trimester pregnant women

Exclusion Criteria:

* psychiatric disorder
* sleep disorder
The Psychosocial Outcomes in Caregivers of Children With Food Allergy

The purpose of this study is to evaluate use of a mobile application (also commonly referred to as an app) designed to support caregivers of children with newly diagnosed food allergy. This study has 2 phases. In Phase 1, the researchers obtained feedback regarding use of mobile apps from caregivers who have been managing their child's food allergy for one year or more. The researchers then used this feedback to build a mobile app for caregivers of children with newly diagnosed food allergy. In Phase 2, the researchers will evaluate the mobile app during a 4-week evaluation period with a group of caregivers of children newly diagnosed with food allergy. The data obtained from this study will hopefully benefit caregivers of children with newly diagnosed food allergy.


Eligibility Criteria:
Inclusion Criteria:

* Caregiver of child less than or equal to 18 years of age who are newly diagnosed (less than or equal to 90 days from diagnosis) with food allergy(ies).

Exclusion Criteria:

* Caregiver with cognitive impairment/deficit and/or observed lack of understanding during the informed consent process
Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults

Using Ketamine for procedural sedation in adults is often uncomfortable for emergency physicians because of the significant proportion of patients experimenting recovery agitation. The investigators believe that combining propofol to ketamine, the proportion of recovery agitation will be significantly lowered.

The objectives of this double-blinded, randomized controlled trial are to compare the proportion of recovery agitation in adults receiving procedural sedation with ketamine-propofol versus ketamine alone, and to compare the proportion of other classical procedural sedation side-effects and parameters such as respiratory depression, hypotension, sedation duration, time of recovery, procedural failures, and levels of satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* indication of procedural sedation

Exclusion Criteria:

* allergy to propofol or ketamine
* alcohol or drug intoxication
* altered mental status
* ASA physical status score \> 2
* hemodynamic unstability
The Effect of Oral Niacinamide on Serum Phosphorus Levels in Hemodialysis Patients

Elevated phosphorus levels are a common problem in dialysis patients. However, it is associated with an increase in death and hospitalizations. Current treatment is comprised of dietary modifications and phosphorus binders - though this is often not enough for many of our patients. Our trial investigates the use of niacinamide, a form of vitamin B, in decreasing serum phosphorus levels.

This is a prospective, randomized, double-blind, placebo-controlled crossover study comparing niacinamide versus placebo in the reduction of serum phosphorus in hemodialysis patients. A determination of baseline laboratory values (serum phosphorus, calcium, albumin, biPTH, uric acid, complete blood count (CBC), and an NMR lipid panel) will precede the administration of the study drugs. The study will span a period of 21 weeks during which phosphorus levels will be checked on a weekly basis. Phosphorus binder dose will remain unchanged unless for safety reasons. For the first 8 weeks of treatment, patients will be randomized to either placebo or niacinamide. Both medications will be administered with a starting dose of one capsule twice per day (BID). Niacinamide and placebo will be formulated in 250 mg capsules. Placebo will be packaged to resemble the study drug in all physical attributes. The dose of niacinamide or placebo will be increased to 500 mg (2 capsules) BID at week 3 and 750 mg (3 capsules) BID at week 5. If hypophosphatemia (\< 3.5 mg/dl) is present, then titration will not occur and the previous dose will be continued. However, titration will resume in subsequent weeks if the serum phosphorus is greater than 3.5 mg/dl. After 8 weeks, patients will undergo a 2 week washout period, then crossover from treatment arm to placebo, or vice versa, at week 11.

At the beginning of week 11, patients will cross over to the other treatment arm (either placebo or niacinamide) at one capsule (250 mg) twice per day. Subsequent titration will occur at week 13 and week 15. The treatment phase will be completed at the end of week 18. A set of labs will be drawn at the start of week 19, followed by a two week washout period.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Capable of giving informed consent
3. Duration of chronic hemodialysis \> 90 days
4. Dose of phosphorus binder(s) stable over previous 2 week period
5. Serum Phosphorus \> 4.9 mg/dL based on most recent laboratory data within 1 month of enrollment

Exclusion Criteria:

1. Pregnancy
2. Known liver disease
3. Active peptic ulcer disease
4. Treatment with carbamazepine
5. Intolerance to niacinamide
6. Current medication regimen including niacin or niacinamide-containing vitamins
7. More than 1 missed hemodialysis session in the last 30 days
8. Planned or expected surgical procedure in the next 4 months
9. Patients in nursing homes or extended care facilities where administration of the study drug may not be appropriately given
Kinematics and Muscle Strength in Two, Five or 10 Years Afther Total Hip Arthroplasty

Introduction: Femoral and acetabular replacement is characterized as total hip arthroplasty (THA). It has been used as treatment of various pathologies of this joint. In the postoperative period, some studies have shown that strength, function, range of motion and lower limb mechanics remains altered for more than One year after THA in relation to the non-operated side. However, studies that have correlated kinematics and hip muscle strength in individuals who underwent THA for long time, do not exist in literature. Objective: to evaluate lower limb muscle strength and 2D kinematics during stair ascending and descending in patients undergoing total hip arthroplasty. Methods: Third individuals who underwent total hip arthroplasty (THA) will be recruited at two, five and 10 year postoperative periods. They were allocated in three groups: Group 1 (10n), subjects submitted to THA for two years, Group 2 (10n) subjects submitted to THA for five years, Group 3 (10n) subjects submitted to THA for 10 years and Group 4 (10n) subjects without orthopaedic afections, all will be evaluated for dynamometric isometric muscle strength and kinematic analysis of stair ascending and descending by a "blinded" physical Therapist.


Eligibility Criteria:
Inclusion Criteria:

* The investigators will recruit 40 individuals who underwent total hip arthroplasty (THA) by the hospital hip surgery group in the periods of two, five and 10 years postoperatively
* Control group without orthopaedic afections. Inclusion criteria: patients submitted to total hip arthroplasty between two years (24 months - 35 months), five years (60 months - 71 months) and 10 years (120 months - 131 months), aged between 50 and 80 years and sign the terms of free and informed consent

Exclusion Criteria:

* patients with a history of prosthesis dislocations or revision of arthroplasty
* hip or lower limb pain
* asymmetry of the lower limbs greater than two centimeters
* previous surgeries in the lower limbs
* limited range of motion in the hip joint
* use of antidepressive drugs or analgesics for continuous use
* Presence of neuromuscular pathologies and functional incapacity to perform the activities proposed in the Kinematics analysis.
Docetaxel and Epirubicin in Advanced Gastric Cancer

1.Study rationale:There is no standard regimen for the advanced and/or metastatic gastric cancer patients who relapsed after adjuvant chemotherapy or failed to first systemic chemotherapy. 2.Primary Objectives:To evaluate overall response rate according to the Response Evaluation Criteria in Solid Tumors criteria and To investigate time to response 3.Design:single-center, Open label, Phase II study. docetaxel 75mg/m2 administered on day 1 as intravenously combined with intravenous Epirubicin 60mg/m2 given day 2 every 3 weeks. 4.Primary endpoints:

1. Efficacy:overall response rate according to the Response Evaluation Criteria in Solid Tumors criteria, time to response, duration of response, and time to treatment failure.
2. Safety-Adverse events and laboratory tests, graded according to the NCI Common Toxicity Criteria for Adverse Effects (version 3.0).


Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients ≥ 18 years,
* Eastern Cooperative Oncology Group performance status below 1, with histologically confirmed as gastric adenocarcinoma with inoperable and/or metastatic disease.
* Patients must have at least one target lesion with a minimum lesion size as per the Response Evaluation Criteria in Solid Tumors criteria (at least 1 unidimensional measurable lesion ≥ 20 mm in diameter by conventional CT or MRI scan, or ≥ 10 mm in diameter by spiral CT scan).
* Creatinine clearance ≥ 60ml/min (estimated creatinine clearance must be calculated at baseline for all patients.)
* Adequate major organ function : - Hematopoietic function: white blood cell \>4,000/mm3 or absolute neutrophil count \> 2,000/mm3, Platelet count ≥ 100,000/mm3,- Hepatic function: Bilirubin \< 1.5 X upper normal limit, aspartate aminotransferase/alanine aminotransferase levels \<2.5 X upper normal limit, alkaline phosphatase \< 5 x upper normal limit (except in case of bone metastasis without any liver disease) - Renal function: Creatinine \<1 x upper normal limit or creatinine clearance ≥ 60ml/min.

Exclusion Criteria:

* Patients must not have previously received systemic treatment (cytotoxic chemotherapy or active/passive immunotherapy) for advanced or metastatic disease.
* Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment.
* The following laboratory values: - neutrophils ≤1.5 X 109 /L, platelet count\<100 X 109 /L- serum bilirubin ≥ 1.5 X upper normal limit, aspartate aminotransferase

  , alanine aminotransferase \> 2.5 X upper normal limit or \> 5 X upper normal limit in the case of liver metastases- Alkaline phosphatase \> 2.5 X upper normal limit or 5 X upper normal limit in the case of liver metastases or \> 10 X upper normal limit in the case of bone disease.
* Prior therapy with Taxotere or Epirubicin is excluded.
Accuracy of a Blood Pressure Measuring Mobile Device in Volunteers

The accuracy and safety of blood pressure module of new mobile device (M- HEALTHCARE device) is evaluated according to Korean FDA guidelines in 100 healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Participants whose systolic blood pressure \<=110 should be at least 10% of whole cohort
2. Participants whose systolic blood pressure \>=160 should be at least 10% of whole cohort
3. Participants whose diastolic blood pressure \>=100 should be at least 10% of whole cohort
4. Participants whose diastolic blood pressure \<=70 should be at least 10% of whole cohort
5. Participants whose arm circumference are between 20cm and 30cm should be 25 - 50% of whole cohort
6. Participants whose arm circumference are between 30cm and 40cm should be 50 - 75% of whole cohort

Exclusion Criteria:

1. heart disease with abnormal rhythm
2. peripheral vascular anomaly or disease
3. inadequate to be applied blood pressure cuff (e.g. trauma on arm)
4. pregnant or lactating women
Gender Dysphoria in Children and Adolescents : Parents' Perspectives

Gender dysphoria is defined as a persistent incongruence between an experienced gender and the assigned sex at birth Transgender and gender nonconforming persons desire to modify their appearance to be consistent with their self-identified gender identities. In non-binary people, contrary to binary transgender persons, self-identified gender identities do not fit the classical pattern male/female.

During the last decennium, an increase in the number of young subjects, especially children and adolescents, referred to gender identity centres has been observed. A new nosological entity "rapid-onset gender dysphoria in adolescents and young adults" has recently been described in the literature, whose etiology has not been well understood.

This growing demand of adolescents and young adults observed in the recent years is not well understood.


Eligibility Criteria:
Inclusion Criteria:

* be a parent of a child \<18 years followed in the endocrinology department of the University Hospital of Nancy for gender dysphoria
* be in stable couple
* both parents agree to participate
* capacity to communicate in French
* Person who has received complete information on the organization of the research and who agreed to the exploitation of the data

Exclusion Criteria:

* Refusal to participate
* Inability to be physically, psychologically or linguistically involved in the study
The Effect of Therapeutic Play During Peripheral Intravenous Catheterisation

Therapeutic play (TP) is a non-pharmacological method used in the pain management in children. This study was conducted to determine the effect of therapeutic play on children's pain, anxiety, and mothers' anxiety during peripheral intravenous catheterisation (PIVC).

The hospitalisation of children due to an acute or chronic illness interrupts play, disrupts their daily routines, places them in an unfamiliar environment, forces them to encounter with unfamiliar people, exposes them to invasive procedures, and makes them suffer from pain and anxiety. Peripheral intravenous catheterisation (PIVC) is probably the most common procedure performed in paediatric clinics. It has been estimated that 80% of hospitalised children have a peripheral intravenous catheter in place. PIVC is a painful and traumatic experience that children usually go through for the first time and frequently during the hospitalisation. This experience of children impairs effective communication between them and healthcare professionals and also causes problems in adaptation to the care and treatment process in the hospital setting. As one of the non-pharmacological pain relief methods, therapeutic play (TP) is a distraction that is defined as "the directed use of toys and materials, which can facilitate children to gain knowledge about the environment and the world they live in, to improve their perceptions thereof and to gain control, for a specific purpose". In order to call play with a child who is hospitalised as therapeutic, the play should encourage children to express their feelings and thoughts during the hospitalisation, assume an educational role in their positive or negative hospital experiences, and bring psychosocial and physical benefits. Children could be told facts such as the hospitalisation, the procedures to be followed and the time when this procedure would end through therapeutic play

Eligibility Criteria:
Inclusion Criteria:

* 3-6 year-old children,
* had no mental disability,
* were able to communicate,
* and had mothers volunteered to participate

Exclusion Criteria:

* none