cyrilzakka/clinical-trials huggingface dataset:
Awareness, Expectations, and Perception of Anomaly Scan Among Mexican Pregnant Women

To describe the knowledge, expectations, and perception of women towards the mid-trimester ultrasound scan to detect fetal anomalies in a Mexican population.

A cross-sectional survey was conducted in two prenatal diagnostic centers located in Monterrey, Nuevo León, México. One was a university prenatal diagnostic center and the other a private one. The centers were purposively selected to represent different characteristics of the level of care and demographic characteristics. The research instrument was a 26-item questionnaire divided into three sections. The first section contained 12 questions designed to assess women's ideas about the purpose and limitations of the scan (yes/no). The second was on expectations before the scan while the third dealt on women´s perception of the fetus during the ultrasound examination. All women attending for a mid-trimester anomaly scan were invited to fill out the first two parts of a pretested structured questionnaire before the scan and after the ultrasound examination, the third part of the questionnaire concerning their experience of the scan session was completed and collected.

Additionally, the questionnaire included demographic questions (age, parity, educational level, marital status). The source of the questionnaire items was interviews with experts.

Ethical approval for this study was obtained from the Institutional review board. The anomaly scan was performed by fetal-maternal specialists between 18 and 24.6-week gestation.

All data were recorded and analyzed using the Statistical Package for the Social Sciences version 22.0 (SPSS Inc, Illinois, USA). Descriptive statistics were used for the sociodemographic data. Categorical variables were compared using the chi-square test or Fisher exact test. Univariate and multivariate regression analyses were performed to delineate the factors associated with a higher knowledge level. A p-value \<0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

-Pregnant women between 18 and 24.6 weeks

Exclusion Crireria:

* Time constraints
* Lack of interest
* Maternal blindness
Ultrasonographic Detection of Musculocutaneous Nerve in Children

Localizing the musculocutaneous nerve for neural blockade is crucial to achieve complete anesthesia of the forearm. However, in pediatric anesthesiology, the musculocutaneous nerve is unable to be blocked in up to 40-50% of cases when only neurostimulation is used, while there is limited information regarding ultrasound imaging of the musculocutaneous nerve in children.

The aim of this prospective imaging study is to investigate whether musculocutaneous nerve is visualized in childhood with the use of ultrasound imaging or not. A secondary aim of this study is to assess the percentage of its visualization according to the age.

Parental written informed consent is obtained from all participants. The children are divided into three groups according to their age: Group 1, with infants aged less than 12 months; Group 2, with toddlers and preschoolers; and Group 3, with school-aged children (6.5-12 years).

Children are placed in the supine position with the involved arm abducted at 90° and the elbow flexed at 90°. The linear probe of a portable ultrasound machine is placed at the axillary region, perpendicularly to the axillary artery. The musculocutaneous nerve is searched near the axillary artery (proximally) and its course is followed distally (into the coracobrachialis muscle). Its sonographic detection is recorded in these two sites, both proximally and distally.


Eligibility Criteria:
Inclusion Criteria:

* children 0-12 years old
* parental written informed consent

Exclusion Criteria:

* parental refusal
* children refusal
* previous operations to the axilla
* anatomical malformations of the axilla
* spasticity
* morbid obesity.
Study of Procoagulation Markers in Stroke Patients

The Insights on Selected Procoagulation Markers and Outcomes in Stroke Trial (I-SPOT): Response to Insulin Administration and Blood Glucose Control proposal is designed to accompany the Stroke Hyperglycemia Insulin Network Effort (SHINE) clinical trial, a Phase III multicenter, randomized, controlled trial planning to determine the efficacy and validate the safety of glycemic control in stroke patients. The SHINE trial will recruit 1,400 AIS patients with Type II diabetes mellitus (T2DM) and hyperglycemia, each receiving 3 days of hyperglycemia control with intravenous (IV) insulin therapy or control therapy with subcutaneous (SQ) insulin. The I-SPOT trial will recruit 315 SHINE patients. Blood coagulation marker levels will be measured before and at 48 hours after the start of treatment. Baseline and temporal changes in biomarkers levels will be compared between treatment groups.

Hypothesis: The decrease in levels of markers of blood coagulation will be greater in patients treated with IV insulin to reduce BG than in patients treated with SQ Insulin as the standard fashion.

Hypothesis: The decrease in levels of markers of blood coagulation will be greater in patients with than without favorable (SHINE) outcome (defined as the baseline stroke severity adjusted measure of functional ability at 90 days after AIS).

Hypothesis: Hyperglycemia control modulates the relationship between blood coagulation levels and functional outcome in T2DM patients after stroke. Patients treated with IV Insulin for hyperglycemia control with favorable (SHINE) outcome will have greater decreases in blood coagulation levels than either IV Insulin-treated patients without favorable outcome or SQ Insulin-treated with or without favorable outcomes at 90 days after AIS.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in SHINE study
* Ability to give Informed Consent (self or LAR)

Exclusion Criteria:

* Current or planned use of full dose anticoagulation from baseline to the 48 hour sample collection
* Known moderate or severe hepatic insufficiency (as defined by INR\>1.5 if known or history of variceal bleeding or hepatic encephalopathy)
* Prior or concurrent thrombotic or hypercoagulable condition (Antiphospholipid antibody syndrome; Antithrombin III, Protein C or S deficiencies; Congenital or Inherited Factor deficiencies; sickle cell disease)
Efficacy of Partial Covered Double Bare Metal Stent Compared to Uncovered Double Bare Metal Stent in Malignant Biliary Obstruction

Previous studies indicated that covered stents are less likely to become occluded in comparison to bare stents. While the probability of occlusions caused by tumor in-growth is less in covered stents, they are more likely to spontaneously migrate to a position that is distal to the original deployment site. However, newer covered stents with improved designs, such as the partially covered double bare metallic stent used for this study, include features to mitigate the migration issue. The purpose of this study is to confirm whether the difference in patency rate between regular covered stents and bare stents, which has already been well established by existing studies, is also reproducible when double covered stents are compared against double bare stents.

Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma, GB cancer, and pancreatic cancer. In biliary stricture by malignancy, biliary drainage with placement of self-expanding metal stent (SEMS) for palliation is the therapy of choice in these patients. When compared to plastic stents, SEMS present a significantly decreased risk of recurrent biliary obstruction. SEMS are also more cost-effective than plastic stents in patients with a life expectancy of longer than 4 months. However, despite their numerous benefits, SEMS become occluded in up to 50 % of patients in the first 6-8 months. In order to minimize the occurrence of this issue, covered stents were developed. Previous studies indicated that covered stents are less likely to become occluded in comparison to bare stents. While the probability of occlusions caused by tumor in-growth is less in covered stents, they are more likely to spontaneously migrate to a position that is distal to the original deployment site. However, newer covered stents with improved designs, such as the partially covered double bare metallic stent used for this study, include features to mitigate the migration issue. The purpose of this study is to confirm whether the difference in patency rate between regular covered stents and bare stents, which has already been well established by existing studies, is also reproducible when double covered stents are compared against double bare stents.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed malignant biliary obstruction or clinically defined malignant biliary obstruction
* malignant biliary obstruction was located more than 1cm from the hilum
* older than 20 years old
* Life expectancy \> 6 months
* Inoperable case due to advanced stage or comorbidity
* Informed consent obtained

Exclusion Criteria:

* Inadequate case for ERCP
* Failed endoscopic approach to duodenum or biliary tract
* biliary obstruction was located at hilum or IHD
* patients with uncontrolled infection
* Pregnancy
* No signed informed consent
Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Eperisone HCl SR Tablet 75mg

The purpose of this study is to evaluate the food effect on the pharmacokinetics of eperisone HCl SR tablet

eperisone hydrochloride(muscle relaxant)

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects age between 20 and 55 signed informed consent

Exclusion Criteria:

* Hypotension or hypertension has a history of allergy reaction of this drug or other drugs
Melatonin in ADHD and Sleep Problems

Treatment with melatonin is often initiated on an insufficient basis as it has not been established prior to starting the treatment whether or not the child had delayed release of endogenous melatonin. At the clinic, it has furthermore been observed that the length of time a child experiences an effect of melatonin treatment varies substantially.

In a clinical context, treatment with melatonin is used increasingly (www.Medstat.dk). However, there is no tradition in Denmark for measuring the endogenous melatonin level before initiating such treatment. Hence there is no way of knowing to what extent the sleep problems were indeed caused by delayed melatonin release.

There seem to be no studies on the difference in the effect of melatonin treatment of children and adolescents depending on whether or not they have delayed DLMO. Likewise, there are no studies including adolescents.

As can be seen, it is important to gain more knowledge about the normal release of melatonin, and the release of melatonin in a group of children and adolescents with a variety of psychiatric diagnoses. It is also essential to investigate whether there are any differences in the release of melatonin in children and adolescents with chronic sleep onset problem and children and adolescents who do not have sleep problems.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 6-13 years referred to the child and adolescent psychiatric department for examination/treatment for ADHD
* Verified Cronical Sleep Problems
* Measured Dim Light Melatonin Onset

Exclusion Criteria:

* IQ below 70
* Autism Disorder
* Actual or former treated with Melatonin
* Allergy to melatonin
Study of Unilateral Neck Irradiation in Patients With SCC of the Head and Neck

The purpose of this study is to assess the feasibility of avoiding opposite side neck radiation therapy in patients with clearly one side squamous cell cancer of the head and neck. We aim to assess the reduction in treatment volume (amount of radiation therapy required), and the resultant xerostomia and mucositis, with the delivery of unilateral neck radiation therapy.

Patients will be treated with definitive external beam radiation plus/minus chemotherapy plus/minus neck dissection in the ipsilateral neck (post radiation). The primary site will be treated with definitive radiation therapy, or definitive surgery plus post-operative radiation therapy. Primary endpoints are loco-regional control, as well as quality of life, xerostomia, mucositis, and neck fibrosis.

Salivary evaluations shall be performed prior to the initiation of radiation therapy, during the second week of EBRT, and at the completion of radiation. Evaluations will also be conducted at 3, 6, and 12 months after the completion of EBRT.

Oral mucositis will be assessed prior to the initiation of EBRT and weekly during EBRT. Evaluations will also be conducted at 3 and 6 months after the completion of EBRT. Two standardized mucositis scales will be used: the RTOG scale and the WHO scale.

Clinical response will be evaluated by physical exam and PET/CT. PET/CT scans will be done at 3, 6, 12, 18, and 24 months, and then when clinically indicated during follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Squamous cell carcinoma of the oral cavity or oropharynx, with the primary lesion \>1 cm from the midline.
* Patient has no clinical or radiologic evidence of contralateral neck node metastases.
* No evidence of distant metastasis.
* No previous history of radiation therapy or chemotherapy
* performance status 0-2
* Age \>= 18
* Signed informed consent
* Patients must be accessible for treatment and follow-up

Exclusion Criteria:

* HIV positive patients
* Pregnancy or any patients not practicing contraception
* Active tobacco or alcohol addiction (as assessed by medical caregiver)
* Serious comorbid disease which prevents delivery of full treatment including psychiatric disorders, cardiopulmonary disease, etc.
* Concomitant use of any trial anticancer therapeutic within 30 days of entry
* Uncontrolled hypertension
* Known hypersensitivity to mammalian cell-derived products
Intensity-modulated Radiotherapy With Integrated-boost in Patients With Spinal Bone Metastases

The primary goal of the study is to determine the local control-rate after radiotherapy (RT) with and without simultaneous integrated boost (SIB) concepts in patients with bone metastases of the spine. Further study objectives are survival, and clinical parameters such as pain, quality of life (QoL) and fatigue. We expect an improvement in local control and consecutively an increased re-sclerotization of the bone metastasis due to a higher biological dose in the tumor area. Therefore patients could benefit in quality-of-life, pain relief and mobility.

The vertebral column is the main localization of bone metastases and is where they frequently indicate an advanced stage of a malignant primary disease \[1, 2\]. Two thirds of all patients with tumors are estimated to develop bone metastases in the course of their disease \[3\]. Spinal bone metastases are of central impact for patients in a palliative setting. The clinical symptoms include pain at rest and under exercise but also impaired activity of daily life, the risk of pathological fractures, and neurological deficits. Local control is the essential factor for stability of the vertebral body of patients with spinal bone metastases. In regard to re-calcification of former osteolytic lesions, palliative radiotherapy (RT) represents an effective treatment option \[4\]. The most common schedule was specified as 30 Gy in 10 fractions. Stereotactic body radiation therapy (SBRT) using intensity-modulated radiotherapy (IMRT) can be a safe modality for treating spinal metastasis with enhanced targeting accuracy \[5\]. Secondly, IMRT to the spine was well tolerated (especially in the spinal cord), had no significant late toxicities, and spared other organs at risk simultaneously \[6\]. The main problem of the standard schedule is the limited dose application to the metastasis due to organ at risk myelon. Therefore, the aims of this study is to apply a high biological dose in the tumor region and to achieve an improved result related to local control for palliative patients with painful spinal bone metastases. Secondly, the aim is to evaluate QoL, fatigue, and survival of three different RT-techniques. To the best of our knowledge, no comparable randomized study has been described in the literature so far.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a histologically confirmed tumor diagnosis, with secondarily diagnosed solitary/multiple metastatic spinal bone metastases
* Indication for RT of the bone metastasis
* Age: between 18 and 80 years
* Karnofsky performance score ≥ 70
* Signed Declaration of Informed Consent
* Bisphosphonate therapy

Exclusion Criteria:

* Significant neurological or psychiatric disorders, including dementia and epileptic seizures
* Lacking or diminished legal capacity
* foregoing radiotherapy in the planned RT area
* Any medical of psychological condition that the study director considers a preventive factor for the patient's ability to complete the study or to adequately understand the scope of the study and to give his/her consent
SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c

The primary objective of this study is to evaluate whether the patients with Type 1 diabetes mellitus in sub-optimal glycemic control can achieve better glycemic control by using the Medtronic MiniMed Paradigm® REAL-Time Pump System with continuous glucose monitoring versus the Medtronic MiniMed Paradigm® REAL-Time Pump alone with Self Monitoring Blood Glucose (SMBG).Our null hypothesis is there is a 0% reduction in HbA1c from baseline compared to control group, after 6 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus diagnosed for at least 12 months prior to signature of informed consent,
* Sub-optimal glycemic control (7.5%\<HbA1c\<9.5%).
* Patient treated by continuous subcutaneous insulin infusion (CSII) for at least 6 months prior signature of informed consent.
* Patient treated within the practice of the investigator's center at least 6 months prior signature of informed consent.
* Patient has no preliminary experience with the sensor function of the Paradigm REAL-Time or the Guardian® REAL-Time for the 4 months prior signature of informed consent.

Exclusion Criteria:

* Existing pregnancy or intention to conceive (as assessed by investigator).
* Hearing or vision impairment so that glucose display and alarms cannot be recognized.
* Three or more incidents in the last 12 months of severe hypoglycaemia with documented Blood Glucose below 50mg/dL (if possible), resulting in unconsciousness, hospitalisation or third party assistance, where recovery follows treatment with glucose or glucagon or similar.
* History of hypoglycemic unawareness as assessed by the investigator.
* Alcohol or drug abuse, other than nicotine.
* Documented cutaneous allergy or disease (allergy to sensor or components of the sensor, psoriasis, staphylococcus, exanthema etc.).
* Any documented concomitant chronic disease known to affect diabetes control (e.g. altered renal function, active cancer undergoing treatment, Crohn's disease, ulcerative colitis, Mb Addison disease) or any concomitant pharmacological treatment that might modify glycemic values (e.g chronic corticosteroid therapy), eating disorders and morbid obesity (defined as adults : Body Mass Index \>35 and children Body Mass Index \> 2 standard deviations. for age) as assessed by the investigator.
* Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol and all study procedures.
* For pediatric subjects: does not have a reliable support person.
* Plans to travel for extended periods (3+ weeks) where the devices cannot be supplied or replaced and/or medical support is limited (eg. exotic countries, remote places).
* Participation in another clinical study, on-going or completed less than 3 months prior to signature of Patient Informed Consent.
TUbal LIgation Per Differents Endoscopic Routes and Sexuality (TULIPES)

The goal of this clinical trial is compare the quality of sexual life at 6 months after tubal ligation, depending on whether it was performed by abdominal laparoscopy or by vNOTES, on the basis of a non-inferiority hypothesis. Participants will answer on the FSFI-19 questionnaire and quality of sexual life will be evaluated according to the score obtained at 6 months post-operative compared to pre-operative.


Eligibility Criteria:
Inclusion Criteria:

* Adult woman, eligible for tubal ligation by total salpingectomy or tubal section coagulation, sexually active at the time of inclusion
* Able to give informed consent to participate in research
* Affiliated to a social security system.

Exclusion Criteria:

* Current pregnancy or breastfeeding
* Indications of another concomitant surgical procedure (other than procedure on the appendix)
* History of upper genital infection
* Proven or suspected rectovaginal endometriosis on clinical examination
* History of rectal surgery
* Virgin patient
* Any concomitant pathology deemed incompatible with the study.
* Uncured COVID or SARS-COv2 positivity dated less than 3 days prior to surgery.
* Protected adult patient, under guardianship or curatorship
* Patients not affiliated to the social security system
* Patients who do not speak French
* Patients under legal protection
* Refusal to participate.
Surgical Outcomes of Conventional Hysterectomy or Manipulator-assisted Abdominal Hysterectomy

Objective: The comparison of surgical outcomes conventional hysterectomy and manipulator-assisted hysterectomy

Study design: Prospective randomized controlled trial. Allocation to either group occurred via computer-generated random numbers. Sequentially numbered, opaque envelopes were prepared according to randomization. The patients were unaware of whether they would undergo a conventional hysterectomy or manipulator-assisted abdominal hysterectomy for their surgical procedure. The research coordinator unveiled group assignments upon individual patient recruitment by opening the corresponding envelope.

Study population: Inclusion criteria were patients aged 40-70 years who underwent hysterectomy for benign gynecological indications.

Primary outcomes: (1) Operation Time.

Secondary outcomes: (1) Postoperative early pain (Visual Analog Score (VAS) at 6th and 24th hours of the surgery) (2) intraoperative complications, (3) postoperative complications


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were patients aged 40-70 years who underwent hysterectomy for benign gynecological indications

Exclusion Criteria:

* Exclusion criteria were patients with additional procedures such as urogynecologic procedures, history of abdominal surgery with midline incision, patients with suspected gynecologic malignancy, endometriosis, tubo-ovarian abscess, pelvic organ prolapse, or those who refused to participate in the study and whose medical records could not be obtained.
Understanding End User Preferences for Hand Hygiene Enabling Technologies in Urban and Peri-urban Lusaka Zambia

The goal of this study is to explore the perceived attributes, acceptability, and use of various improved handwashing facility designs.

The study aimed to establish what are the characteristics of handwashing facilities (attributes) that are prioritized among various groups of potential end users and how do existing improved HWF designs rank according to these preferences? Also how acceptable are promising HWF designs among multiple groups of potential end users in a real-world setting, how do potential users adapt and modify existing HWF for use in their homes.


Eligibility Criteria:
Inclusion Criteria:

* Living within the designated study area
* Meeting category requirements (i.e adult male, adult women, caregivers of under 5 or elderly (\>65)

Exclusion Criteria:

* Not from within designated area
* Less than 18 years of age