cyrilzakka/clinical-trials huggingface dataset:
1-1-8 Wash-in for Sevoflurane Low Flow Anesthesia

The investigators propose a new wash-in technique for sevoflurane low flow anesthesia with fresh gas flow of O2:N2O or O2:air 1:1 L/min with sevoflurane 8%.

The objective of this study is to identify time to achieve alveolar concentration of sevoflurane at 1, 1.5, 2, 2.5, 3, and 3.5%

The benefits of low flow anesthesia are economic, less pollution, more heat and humidity preservation but it requires appropriate wash-in phase. The current wash-in protocols for sevoflurane are complicated and time consuming. The investigators propose a new 1-1-8 sevoflurane wash-in protocol which is more simple and predictable.

The objective of this study is to identify time to achieve alveolar concentration of sevoflurane at 1, 1.5, 2, 2.5, 3, and 3.5% with 1-1-8 wash-in protocol.

All patients will receive iv propofol 2 mg/kg as induction agent and succinyl choline 1.5 mg/kg for intubation. Then the ventilation will be controlled to achieve end-tidal CO2 30-35 mmHg with O2:N2O or O2:air 1:1 L/min with sevoflurane 8%. Time to achieve alveolar concentration of sevoflurane at 1, 1.5, 2, 2.5, 3, and 3.5% will be recorded and analyzed. After that, the concentration of sevoflurane and anesthetic technique will be adjusted to requirement of anesthesiologist.

Eligibility Criteria:
Inclusion Criteria:

* ASA classification I-II
* age 18-65 years

Exclusion Criteria:

* BMI \> 35
* contraindicated for N2O
* • with pulmonary or cardiac disease
The Prevalence and Clinical Characteristics of Children With Local Allergic Rhinitis

* To determine prevalence of local allergic rhinitis (LAR)
* To evaluate clinical characteristic and severity of local allergic rhinitis
* To measure changing of tryptase and Specific IgE for Dermatophagoides pteronyssinus (Dp) after nasal allergen provocation test (NAPT)

Children 8-18 years with NAR were recruited. A NAPT with Der p 1 solutions (NAPT-DP) at 200 AU/mL, 600 AU/mL and 2000 AU/mL at 15-minute interval was performed, respectively. The immediate responses to NAPT-DP were assessed using symptoms score, peak nasal inspiratory flow (PNIF) and acoustic rhinometry (ARM). The nasal tryptase and sIgE-DP were measured at baseline, 15 min and 1 h after positive NAPT-DP. Allergic rhinitis (AR) patients were used as positive control.

Eligibility Criteria:
Inclusion Criteria:

* Children 8-15 years who were diagnosed with nonallergic rhinitis (NAR) at least 1 year
* No respiratory infections in the previous 4 weeks
* No following treatment of
* systemic corticosteroid 4 weeks
* intranasal corticosteroid 2 weeks
* oral antihistamine 1 week
* leukotriene antagonist 1 week

Exclusion Criteria:

* Patients with underlying disease:
* chronic rhinosinusitis and nasal polyp
* immunological disease
* chronic renal disease
* hepatobiliary disease
* cardiovascular disease
* cancer
* Parental withdraw consent
* Patient with uncontrolled asthma, peak expiratory flow rate (PEFR) \< 80% of predicted
Can Right Toe Perfusion Index or Pleth Variability Index Predict Spinal Anesthesia Induced Hypotension?

Spinal anesthesia for caesarean section is associated with a decrease in systemic vascular resistance and cardiac output and may cause hypotension in a significant portion of the parturients. Hypotension during delivery may cause maternal and fetal complications. If parturients who are likely to develop hypotension after spinal anesthesia can be identified before surgery, anesthesiologists would have opportunity to take measures such as prophylactic vasopressor administration. Perfusion index (PI) measured by pulse oximetry reflects vasomotor tone which affects the degree of hypotension after spinal anesthesia. This is a non-invasive method of assessing the relative vascular tone with the use of pulse oximeter which calculates the ratio of pulsatile versus the non-pulsatile component of the blood flow. A lower PI indicates greater peripheral vasomotor tone. Pleth variability index (PVI) is calculated using maximum and minimum values of perfusion index during respiratory cycles. PVI is one of the dynamic indices that can predict fluid responsiveness. There are several studies investigating the predictive value of finger PI and PVI on hypotension after spinal anesthesia. However the aortocaval compression by the gravid uterus directly effects the lower extremity perfusion. So, in this study we aimed to investigate whether the right toe PI and PVI values at supine and left lateral positions can predict hypotension during caesarean section.


Eligibility Criteria:
Inclusion Criteria:

* singleton parturient
* planned for elective LSCS under spinal anesthesia

Exclusion Criteria:

* gestational age \< 36 weeks

  * emergency cases
  * placenta previa, pre-eclampsia
  * BMI\>40
  * Reynauld disease
  * patient refusal
  * cardiovascular disease
Microwave Ablation for Leiomyoma

This prospective observational study aims to evaluate the effectiveness and acceptability of percutaneous or vaginal ultrasound guided microwave ablation for the treatment of symptoms related to uterine fibroids. We will include 200 women.


Eligibility Criteria:
Inclusion Criteria:

* premenopausal
* no future child wish
* acceptable risks for general anestesia or sedation
* willing to comply with protocol

Exclusion Criteria:

* current or future child wish
* bleeding disorder with increased risk of bleeding
Comparison of Two Surgical Techniques for Open Subpectoral Biceps Tenodesis

Participants who are indicated for an open biceps tenodesis procedure will be recruited to join the study. The participant will undergo the standard biceps tenodesis procedure using either one standard anchor or two mini anchors by the study staff surgeon. Both techniques are safe and considered standard of care. The participant will be randomized to either group. After the biceps are secured in the standard fashion, a sterile radiolucent bead will be applied to the tendon. The participant will undergo xray imaging in the post-anesthesia care unit to determine a baseline measurement of the location of the radiolucent bead. The participant will then undergo further xray imaging at their 2 week and 6 month-up visits.

Participants who are indicated for an open biceps tenodesis procedure will be recruited to join the study. The participant will undergo the standard biceps tenodesis procedure using either one standard anchor or two mini anchors by the study staff surgeon. Both techniques are safe and considered standard of care. The participant will be randomized to either group. After the biceps are secured in the standard fashion, a sterile radiolucent bead will be applied to the tendon. This will allow for measurements to be made on xray imaging in the post-operative period. The placement of the clip is the only experimental portion of the procedure. The participant will undergo xray imaging in the post-anesthesia care unit to determine a baseline measurement of the location of the radiolucent bead. The participant will then undergo further xray imaging at their 2 week and 6 month-up visits. These visits are standard visits for the participant who undergo this procedure.

Eligibility Criteria:
Inclusion Criteria:

* Participant age 18 and above who would otherwise indicated for biceps tenodesis due to biceps tendinopathy with or without associated rotator cuff pathology

Exclusion Criteria:

* Participant under the age of 18 will be excluded from the study as there is no indication to perform this procedure in children.
* Any participant who had previous surgery or injury to their biceps or biceps tendon will be excluded.
Evaluation of the Efficacy of the Watch Your Weight During Holidays Program for the Prevention of Body Weight Gain in Mexican Adults.

Obesity is the main risk factor for the development of chronic-degenerative diseases in Mexico. Due to the difficulty of treating obesity, prevention is urgently needed. The holidays are the festive period with the greatest impact on adult body weight. Evidence from observational studies has shown that more than 50% of the annual weight is gained during this period. However, few preventive interventions have been carried out worldwide. The present work will evaluate the efficacy of the Watch your Weight During Holidays Program on the prevention of weight gain during 8 weeks in comparison with the control group in Mexican adults. The study will be a randomized clinical trial. It will have two intervention groups: 1) Watch your Weight During Holidays Program and 2) Control Group (minimal intervention). Weight, height, body mass index, waist circumference, kilograms of body fat, fat mass index, cm2 of abdominal fat, blood pressure and perception of health-related quality of life will be measured in 64 volunteers, at the beginning and after 8 weeks of participating in Watch your Weight During Holidays Program. For comparisons between groups, Student's t-tests or Mann-Whitney's U-tests will be performed, according to the type of sample distribution. The primary variable of the study will be the change in body weight. The secondary variables will be the change in body mass index, waist circumference, kilograms of fat mass, fat mass index, cm2 of abdominal fat, blood pressure and aspects of perception of quality of life related to health.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 and ≤60 years of age).
* Residents of the city of Hermosillo, Sonora.
* BMI ≥ 23 and ≤ 40.
* Availability of time to participate in the study, including initial and final measurements.
* Have a device with access to WhatsApp
* Accept not to carry out any other intervention outside of the one assigned in the study during the 8 weeks of the intervention.

Exclusion Criteria:

* Have medical conditions due to previous diagnosis, which require the prescription of treatments that affect weight, such as diabetes and thyroid diseases.

Other exclusion criteria will be liver failure, cancer under treatment or at an advanced stage, a history of COVID-19 that has required hospitalization, supplemental oxygen or left sequelae that contraindicate the intervention; psychiatric conditions, eating disorders, etc.

* Use of drugs or substances with an effect on weight, for example, metformin, orlistat, corticosteroids, etc.
* Use of addictive substances such as drugs of abuse
* Previous bariatric surgery.
* Being a participant in another intervention or treatment for the management of obesity.
* Weight loss \> 5% of total body weight in the last 4 months.
* Having plans to become pregnant within the study period, currently pregnant or breastfeeding.
* Another family member has agreed to participate in the study.
* Illiteracy
Tell Me More ("Dime Mas")

This study will be used to develop a program to help Latino men who have sex with men obtain pre-exposure prophylaxis (PrEP), HIV testing, and behavioral health services. The project will then involve a pilot test of this program with a community partner.


Eligibility Criteria:
Inclusion Criteria:

* Identify as Latino/Hispanic
* identify as a sexual minority man (e.g., gay, bisexual) and/or a man who has sex with men
* age 18 years or older
* English and/or Spanish speaking
* self-report an HIV-negative or unknown HIV status
* currently reside in the greater Miami area
* PrEP eligible (based on Centers for Disease Control (CDC) criteria) and not currently taking PrEP adherently
* self-report experiencing one or more clinically significant behavioral health concerns (mental health, substance use) and/or are not currently receiving behavioral health services or self-report an unmet need for behavioral health services

Exclusion Criteria:

* Unable to provide consent
* Opinion of the PI that the participant would be at risk for harm to self or others
* Have a medical or psychiatric condition that would interfere with ability to participate in study procedures in the opinion of the PI
* Involvement in any other HIV prevention or behavioral health study that may interfere with the ability to test major study outcomes (evaluated by the PI on a case-by-case basis)
An Open Label Prostate Cancer Study in Japanese Patients

The primary aim of study is to gain an initial assessment of safety and tolerability of AZD3514 in Japanese patients together with assessing Pharmacokinetics (PK) and gaining a preliminary assessment of anti-tumour action. In this study, AZD3514 will be administered to Japanese patients with metastatic castration resistant prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Males aged 20 years or older.
* Histologically or Cytologically proven diagnosis of prostate cancer for which no standard therapy is currently considered appropriate
* Documented evidence of metastatic prostate cancer
* Serum testosterone concentration ≤50 ng/dL
* World Health Organisation (WHO) performance status 0 to 1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks

Exclusion Criteria:

* History of hypersensitivity to active or inactive excipients of AZD3514 or drugs with a similar chemical structure or class to AZD3514
* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD3514
* Inadequate bone marrow reserve or organ function
* Concurrent or recent treatment with certain medications or medical procedures
* Any medically important factors identified from electrocardiogram (ECG) measurements
Cervical Parameters and Body Awareness in Relation to Smartphone Addiction

The study was planned as a observational, cross-sectional study


Eligibility Criteria:
Inclusion Criteria:

* being a smartphone user
* being between the ages of 18 and 25

Exclusion Criteria:

* neck pain
* radicular pain
* neurological symptoms
* cervical surgery or cervical trauma
Pre-operative Olanzapine as Prophylactic Antiemetic in Oncologic Patients

Olanzapine has been used as prophylactic antiemetic for chemotherapy induced nausea and vomiting.

The project aims to evaluate the efficacy of olanzapine in combination with ondansetron and dexamethasone in patients at high risk of postoperative nausea and vomiting, with previous history of nausea and vomiting induced by prior chemotherapy, submitted to medium and large surgery.

Double blinded randomized clinical trial. Fifty patients will be selected for each group. Group A will receive 10mg olanzapine in the preoperative and group B will receive placebo in the preoperative period. Both groups will receive intravenous general anesthesia combined with epidural. All patients will receive epidural PCA.

The primary outcome of this study is the incidence of post-operative nausea and vomiting. The power of analysis was based on the following parameters: type error I (α = 0.05), error II (β = 0.8), 95% confidence interval and hypothesis test two-tailed. Thus, 42 patients are indicated per group to obtain reduction of the incidence of nausea and / or vomiting of the population risk from 60% to 30%. The population will be composed of 100 patients because it is assumed that percentage of loss of 10% per group.

The statistical analysis will be performed in program R version 3.5.1. The results obtained will be presented as mean + standard deviation for continuous data or absolute frequency for described data.

For quantitative variables, the Student's t-test will be used for with normal distribution or Mann-Whitney for non-distributed data normal.

For qualitative variables, the chi-square test will be used or Fisher's exact test. Significant difference is defined as p, 0.05.

Data will be collected and managed using REDCap data capture tools

Eligibility Criteria:
Inclusion criteria:

* Patients submitted to medium and large surgeries in the thoracic or abdominal region (mastectomies, breast plastic, hysterectomies, annexectomies, gynecological pelvic surgeries, colectomies, rettosigmoidectomies) under general anesthesia
* Patients aged between 18 and 60 years
* Patients considered to be at high risk for PONV according to the Apfel scale (Apfel 3 or 4)
* Patients with a history of chemotherapy-induced nausea and vomiting.

Exclusion criteria:

* Pregnancy or Lactation
* Current use of typical anti-psychotic medications or atypical
* History of allergy to olanzapine
* Myocardial infarction or unstable angina in the 6 months prior to the day of surgery planning
* History of severe ventricular arrhythmia (eg, VT or VF)
* Heart Failure Class II or greater second NYHA
* Postural hypotension or vasovagal syncope in the 6 months prior to the day of surgery planning
* Narrow angle glaucoma
* Parkinson's disease
* Dementia
* Inability to swallow medicines
* QT interval history greater than 450ms or torsades de pointes
* Patient does not want to participate in the study
* Videolaparoscopy surgery
* Contraindication for neuraxial block
Intervention for Sleep and Pain in Youth

This study tests the feasibility, acceptability, and preliminary efficacy of a seven-session cognitive-behavioral therapy intervention to treat sleep and pain problems in youth ages 11-17 with co-morbid headache and insomnia.

Cognitive-behavioral interventions have been developed to treat childhood insomnia and childhood headache. In this study, we have combined strategies from these interventions into a single, seven-session protocol to treat sleep and pain problems in youth with co-morbid headache and insomnia. In this single-arm pilot study, we will test the feasibility, acceptability, and preliminary efficacy of this intervention.

Eligibility Criteria:
Inclusion Criteria:

* youth age 11-17 years
* chronic headache and insomnia symptoms for the past 3 months as determined on screening interview with youth and parent.

Exclusion Criteria:

* youth and parent do not read or speak English
* youth with active suicidal ideation or psychosis
* youth with diagnosis of a comorbid serious health condition (e.g., cancer, diabetes)
* youth with severe cognitive impairment
* youth with another primary sleep disorder (e.g., sleep apnea, narcolepsy) or an unusual sleep/wake schedule or circadian rhythm disorder.
Metabolism and Pharmacokinetics of [14C]-BIBF 1120 in Healthy Male Volunteers

To assess the metabolic profile,

to obtain the mass balance after oral administration,

to determine the concentration of \[14C\]-radioactivity in blood cells, plasma, urine and faeces,

to determine BIBF 1120 and BIBF 1202 concentrations in plasma, urine, and faeces, if feasible,

to determine the protein binding of \[14C\]-radioactivity,

to determine the pharmacokinetics of BIBF 1120, BIBF 1202 and total radioactivity after a single oral administration of \[14C\]-BIBF 1120 in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects as determined by results of screening
2. Signed written informed consent in accordance with GCP and local legislation
3. Age ≥21 and ≤55 years
4. Body Mass Index ≥18.5 kg/m2 and ≤29.9 kg/m2

Exclusion Criteria:

1. Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
2. History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
3. History of any major surgery within the last four weeks before participation in this study or any bone fracture within the last two months
4. History of orthostatic hypotension, fainting spells and blackouts
5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
6. Chronic or relevant acute infections
7. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
8. History of any bleeding disorder including prolonged or habitual bleeding, other haematologic disease or cerebral bleeding (e.g. after a car accident) or commotio cerebri
9. Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
10. Planned use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
11. Participation in another trial with an investigational drug within 2 months prior to administration or during trial
12. Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
13. Alcohol abuse (\> 60 g/day)
14. Drug abuse
15. Blood donation within 1 month prior to administration or during the trial
16. Excessive physical activities within 5 days prior to administration or during the trial
17. Any laboratory value outside the reference range, unless considered to lack clinical reference
18. Female gender
19. Male subjects must agree to minimize the risk of female partners becoming pregnant from the dosing day until 3 months after the completion of the study. Acceptable methods of contraception for male volunteers include a vasectomy no less than 3 months prior to dosing, barrier contraception or a medically accepted contraceptive method. For female partners of male volunteers, acceptable methods of contraception include intra-uterine device, tubal ligation, hormonal contraceptive since at least two months and diaphragm with spermicide