cyrilzakka/clinical-trials huggingface dataset:
A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations

This was a study that compared the efficacy and safety of a generic butoconazole nitrate vaginal cream, 2% to Gynazole-1 (butoconazole nitrate) Vaginal Cream, 2% in the treatment of vulvovaginal candidiasis caused by Candida species.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects, at least 18 years of age
* Presented with symptomatic vulvovaginitis consistent with a diagnosis of moniliasis
* Signed and dated informed consent

Exclusion Criteria:

* Were pregnant, nursing, or planning a pregnancy within the study participation period
* Had evidence of any bacterial, viral, or protozoal infection
* Had hypersensitivity or allergy to the imidazoles, their analogues, and/or any of the Test Product ingredients
* Had any medical condition, or used any medication which, in the opinion of the investigator, could have interfered with the conduct of the study
Reliability of Waveform Analysis as an Adjunct to Loss of Resistance for Obstetrical Epidural Blocks

In this study, we will set out to confirm the reliability of epidural waveform analysis (EWA) as an adjunct to loss of resistance for obstetrical epidural blocks.

After loss of resistance, 5 mL of normal saline will be injected through the epidural needle; the latter will then be connected to a pressure transducer (leveled with the heart) using a rigid tubing. A pressure recording of the epidural waveform will be saved for future assessment by a blinded observer.

After the recording of the waveform, the rigid tubing will be disconnected from the epidural needle. A 4 mL bolus of lidocaine 2% with epinephrine 5 µg/mL will be injected through the latter. An epidural catheter will be advanced 3-4 cm past the tip of the needle inside the epidural space. The needle will then be removed and the catheter secured to the skin in the usual fashion.

Fifteen minutes after the injection of the local anesthetic bolus, a blinded observer will apply ice to the T1-L5 dermatomes and assess the epidural block.

Eligibility Criteria:
Inclusion Criteria:

-American Society of Anesthesiologists classification 1-3

Exclusion Criteria:

* adults who are unable to give their own consent
* coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
* renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie creatinine ≥ 100)
* hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie transaminases ≥ 100)
* allergy to local anesthetic
* prior surgery in the lumbar spine
Testing Spectrosense EVA System for Detection of Breast Cancer by Analyzing Volatile Organic Compounds (VOCs) in Exhaled Air

Volatile Organic Compounds (VOC) in human breath are captured and analyzed by the Spectrosense EVA system, which is combination of a gas chromatography (GC) and software algorithm. The objective is to obtain a set or sets of VOC bio-markers that will provide the best discrimination between Breast Cancer sick population and healthy population. The gold standard for identifying sick/healthy population is biopsy proven breast cancer.


Eligibility Criteria:
Breast Cancer group:

Inclusion Criteria:

* Age from 18 years old
* Breast cancer positive biopsy
* Before any treatment
* Signed Informed Patient Consent

Exclusion Criteria:

* Age under 18 years old
* Neoadjovant treatment
* Post surgery for breast cancer
* A history of any other cancer type, except skin cancer that is not melanoma

Healthy group:

Inclusion Criteria:

* Healthy women
* No history of Breast cancer
* Signed Informed Patient Consent

Exclusion Criteria:

* History of Breast cancer
* Breast cancer background in the family
* A history of any other cancer type, except skin cancer that is not melanoma
Effect of Sensory Integration in Speech Therapy for Children With Autism

Autism spectrum disorder (ASD) is considered one of the commonest developmental disabilities, characterized mainly by impairments in social performance and communicative skills, repetitive stereotypical behaviors, and restriction in interests and activities, with a combination of sensory, cognitive, behavioral, and communication features which persist throughout life. Caminha \& Lampreia specified that there is a significantly high prevalence of sensory processing dysfunctions in ASD. Sensory processing means how the central and peripheral nervous systems deal with the incoming sensory input from different sensory organs; visual, auditory, smell, taste, tactile, proprioception, and vestibular information. Sensory processing dysfunction is the neurological dysfunction affecting the adequate reception, modulation, integration, discrimination, or organization of sensory stimuli, and the behavioral responses to the sensory input. Sensory integration therapy (SIT) is a frequent type of therapy that aims to improve a child's ability to perceive and integrate sensory input in order to explore more ordered and appropriate actions. SIT improves motor skills, social relationships, attention, behavior control, language and pre-linguistic communicative abilities, reading comprehension, participation in play activities, and personal identification. Therefore, the need for further explicit assessment of sensory integration intervention among ASD children has been increased to identify its gains in social and verbal interactions. This study aimed to estimate the impact of sensory integration therapy on language development in autism spectrum disorder children.46 ASD children will enroll in this study, their ages ranged from 3-10 years, males and females, divided into two groups (group I received speech therapy sessions together with sensory integration therapy sessions, group II received speech therapy sessions only) went through two stages of evaluation before and after receiving their sessions with one year apart. All children were subjected to Childhood Autism Rating Scale (CARS), sensory profile assessment by Short Sensory profile (SSP) and Assessment of Basic Language and Learning Skills- Revised (The ABLLS-R).Data will be taken from Clinics and Schools having children with autism


Eligibility Criteria:
Inclusion Criteria:

* Pre diagnosed autistic children
* Both male and female
* Age range:3 years to 10 years
* Moderately severe

Exclusion Criteria:

- Autism with any comorbid will be excluded ( hearing impaired, Any syndrome)
A Prospective Study Comparing the Outcomes of Single Versus Group Culture in Preimplantation Genetic Testing Cycles

The aim of this study is to analyze whether there is difference in the effect of single embryo culture and group culture in preimplantation genetic screening (PGS) cycle, and provide reference for the feasibility of the clinical application of medium-based noninvasive PGD. This prospective study prepares for more than 1,000 normal fertilized zygotes in each group over one year period. For the recruited patients, all normal fertilized zygotes were randomly allocated into two groups: cultured individually in 25 ul media or 2-3 embryos cultured together in 50 ul media. The blastocyst formation rates, aneuploid rates, clinical pregnancy rates, implantation rates and miscarriage rates will be compared between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* patients treated by preimplantation genetic diagnostic / screening cycles

Exclusion Criteria:

* number of normal fertilization zygotes is less than 6
Effect Evaluation of The International Child Development Programme (ICDP)

This study evaluate if a parental guidance programme based on the International Child Development Programme (ICDP) offered to the general Norwegian population, has an effect on caregivers, the relationship between caregiver and child, and on children's Development.

The International Child Development Programme (ICDP) is a psychosocial preventive programme offered to parents and other caregivers. The programme aims to improve parenting practices and thereby child development and well-being. The ICDP is designed to influence and improve the quality of contact and relation between the caregivers, usually parents, and their children through the practical application of eight themes or guidelines for positive interaction. ICDP courses are implemented in a group format and include group discussions, caregiver assignments, and report back through a sequence of eight meetings. The caregiver groups are led by facilitators trained in the ICDP, and with the competence to lead such groups.

The aim of this study is to evaluate if ICDP has an effect on caregiver's positive involvement and sensitivity to childrens emotions, and on parental self-efficacy. The study will also evaluate the effect of ICDP on caregiver-child relationships, and the children's development and well-being.

The study will use a stratified cluster randomized control design, and will be implemented in regular clinical practice in Norway.

More knowledge within this field is important for practitioners as well as policy makers in planning preventive interventions for caregivers ant their children.

Eligibility Criteria:
Inclusion Criteria:

* Caregivers with children between the age of 0-18 years, from the general Norwegian population
* Participants must be able to speak and write adequately Norwegian

Exclusion Criteria:

* Not having children between 0-18 years
* Insufficient Norwegian language skills
* ICDP imposed by resolution in the Fylkesnemnda
Efficacy Study of an Audio Device Outside Incubator Allowing Broadcasting Maternal Voice on Stability in Preterm Infants

The study aims to evaluate the impact on the preterm infants' short-term physiological, neurodevelopmental states by employing maternal voice intervention in NICU routine care. This study also evaluates the correlation between effective intervention and maternal depression by employing Edinburgh Postnatal Depression Scale .

The study designs a two-arm, double blind randomized control trial (RCT) experiment in terms of a block randomization for allocating participants in experimental and control groups respectively. In the experimental group maternal voice in terms of lullaby, music, and meaningful words plays near the head of premature infant in the incubator by 30 mins each time, and totally three times a day over a 14-days intervention duration. Meanwhile a standard care treats premature infants in the control group. A IntelliVue physiological monitor and a behavior scale collects ECG, respiratory rate, SpO2 concentration, and sleep/awake states of premature infants in both groups. Finally, ANOVA analyzes the statistical significance between the measurer and items.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants at 28-36 gestational age
* Within 10 days in NICU after delivery

Exclusion Criteria:

1. Has a known chromosomal or congenital abnormality
2. Major congenital infection
3. Brain lesions diagnosed prenatally, or neonatal asphyxia at birth.
4. Toxic use by the mother during pregnancy
5. Intraventricular hemorrhage of third degree or more occurred in brain ultrasound examination
6. Are using sedative medication
7. Premature infants use endotracheal tube respirator or high-frequency respirator
8. Preterm infants requiring immediate surgical treatment at birth
Teenage Pregnancies in Refugee and Migrant Adolescents on the Thai-Myanmar Border

This study is to explore perceptions, experiences, beliefs and knowledge around teenage pregnancy, motherhood, sexual and reproductive health, family planning and support structures adolescent refugees and migrants and to identify demographic, social and medical characteristics of study participants.

The study will be conducted as follows:

* 12-24 individual interviews with pregnant or postnatal adolescent girls (\<20 years);
* 1 Focus group discussion of 6-10 non-pregnant female adolescents (\<20 years);
* 1 Focus group discussion of 6-10 adolescent men (\<20 years);
* 1 Focus group discussion of 6-10 Shoklo malaria research unit antenatal care staff;

Interviews and focus group discussion will be conducted with study participants who agree to participate in discussions about teenage pregnancy and motherhood, sexual and reproductive health. In-depth interviews and focus group discussion will be conducted in private meeting rooms in proximity to the antenatal clinic waiting areas. In-depth interviews and Focus group discussion will be co-facilitated by the principal investigator and a trained counsellor/midwife fluent in Karen, Burmese and English. Focus group discussion will be run separately for Burmese- and Karen-speaking participants and participants will be separated by subgroup. Focus group discussion will include 6-10 participants per group and for each focus group discussion to last between 45-60 minutes. Individual in-depth interviews will last approximately 60 minutes each.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for adolescent mothers (subgroup 1) are:

* Aged 12 - \<20 years
* Females
* Migrant or refugee status
* Myanmar nationality
* Any trimester of pregnancy or up to 12 month post partum
* Able and willing to participate and give informed consent

Inclusion criteria for non-pregnant female adolescents (subgroup 2) are:

* Aged \<20 years
* Females
* Migrant or refugee status
* Myanmar nationality
* No past or current pregnancy
* Able and willing to participate and give informed consent

Inclusion criteria for adolescent men (subgroup 3) are:

* Aged \<20 years
* Males
* Migrant or refugee status
* Myanmar nationality
* Able and willing to participate and give informed consent

Inclusion criteria for health staff (subgroup 4) are:

* No age restrictions
* Females or males
* Migrant, refugee or non-migrant status
* Any nationality
* Able and willing to participate and give informed consent

Exclusion Criteria:

* Any participant who is deemed by the researchers or health staff to be acutely physically or mentally unwell will be excluded.
* Participants who do not meet the age requirements, migration status or nationality requirements
Longitudinal Follow up of Patients With Pleural Effusion

This study aims to evaluate the clinical course of patients diagnosed with pleural effusion and determine various clinical factors and biomarkers associated that can predict the diagnosis and clinical outcome and prognosis of patients with pleural effusion due to specific causes.

Patients who presented to Seoul National University Bundang Hospital with pleural effusion would be recruited. Pleural fluid and blood samples would be collected. All patients will receive routine diagnostic procedures and medical care and treatments according to the diagnosis; the original cancer if diagnosed with malignant effusion, and managements for pleural effusion control. Patients would be observed for the clinical course and prognosis up to 3 years without any interventions caused by this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients presented with pleural effusion
* Patients who undergo thoracentesis and fluid analysis for diagnosis and management

Exclusion Criteria:

* Patients who refuse to be enrolled
Stem Cell Transplant for Bone Marrow Failure Syndromes

The researchers hypothesize that it will be possible to perform unrelated bone marrow or cord blood transplants in a safer manner by using less intensive therapy yet still achieve an acceptable level of donor cell engraftment for non-malignant congenital bone marrow failure disorders.

Prior to transplantation, subjects will receive the drugs busulfan (orally or through the catheter), as well as fludarabine and anti-thymocyte globulin (ATG) via the catheter. Busulfan, fludarabine and ATG will be given with Total Lymphoid Irradiation (TLI) to help the new donor bone marrow take and grow after transplantation.

Those patients receiving donor marrow will have the T cells (a type of white blood cell in the donor marrow) removed to lower the risk that the new marrow will react to their body, a condition called Graft-Versus-Host-Disease (GVHD). After bone marrow transplantation, subjects will receive drugs to help prevent GVHD, including cyclosporin and mycophenolate mofetil (MMF).

Blood samples are taken at day 28, day 60, day 100, 1 year and as required by medical status yearly for five years after transplant to evaluate how well the new marrow is growing. A bone marrow biopsy is required at day 21, at day 100 and 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for transplantation under this protocol will be \<35 years of age, and will be diagnosed with:

  * a bone marrow failure syndrome unresponsive to available therapy, including but not limited to Diamond-Blackfan anemia, Shwachman Diamond syndrome or Kostmann's neutropenia but exclusive of aplastic anemia.
* Diamond Blackfan Anemia:

  * Patients must show evidence of steroid resistance requiring equivalent of \>6 transfusions yearly despite steroid therapy.
  * Evidence of developing aplasia or myelodysplasia will also be criteria for transplantation.
* Kostmann's Neutropenia, Shwachman-Diamond syndrome:

  * Patients must have been previously diagnosed as having a clinical picture characteristic of Shwachman-Diamond syndrome (exocrine pancreatic insufficiency, growth retardation, metaphyseal dysostosis, neutropenia), or must have a bone marrow aspirate consistent with Kostmann's neutropenia, with no evidence of acute leukemia.
  * Patients must have failed therapy with granulocyte-colony stimulating factor (G-CSF), as determined by an inability to maintain an absolute neutrophil count (ANC) \>750 cells/ml(3), or manifesting recurrent infections despite G-CSF administration resulting in life threatening infections or repeated hospitalizations (\<4 /year).

Exclusion Criteria:

* Patients \>35 years of age
* Karnofsky score \<70%
* Hepatic dysfunction as determined by bilirubin \>3.0, ALT \>150, or active hepatitis
* Pulmonary function tests with forced volume vital capacity (FVC) and forced expiratory volume (FEV) \<70%; O2 saturation \<94%
* Renal dysfunction with glomerular filtration rate (GFR) \<30% of predicted.
* Cardiac compromise, with left ejection fraction \<45%.
* Severe, stable neurologic impairment.
* Human immunodeficiency virus (HIV) positivity.
* Pregnant or lactating females
A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* The patient is male or female 18 to 65 years of age, inclusive.
* The patient has a diagnosis of primary FM as defined by the 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology Preliminary Diagnostic Criteria)
* The in-clinic 7-day recall NRS average daily pain intensity score at Screening Visit within protocol specified range.

Exclusion Criteria:

* History of or evidence for a diagnosis of borderline personality disorder (BPD).
Resident Posture Biofeedback Study

While a majority of surgical ergonomic studies have been evaluating attending surgeons, few have evaluated surgical ergonomics within the surgical resident. Biofeedback devices can be partnered with education and geared towards surgical residents to decrease current and future musculoskeletal disorders, which may in turn lead to longer and more fulfilling careers.

This study aims to use a commercially-available posture training device for surgical residents that sends biofeedback in the form of a gentle vibration if posture has deviated from the upright (neutral) position for a long period of time. For residents performing minimally-invasive procedures with a laparoscopic approach, our overarching hypothesis is that the time spent in a non-upright position will be less after using the posture biofeedback device compared with before. The study hypothesizes that residents will report fewer complaints related to musculoskeletal pain after wearing the posture training device.

Residents completing general surgery rotations will be recruited and wear a biofeedback device for about four weeks while performing laparoscopic procedures. Posture data from the device and survey data in the form of the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) will be collected and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Surgical residents with surgical experience of at least one year (Postgraduate year 2-5)
* Completing a one-month rotation at the study sites within the general surgery department during the study period

Exclusion Criteria:

* Clinically diagnosed inflammatory musculoskeletal disorders per self-report
* History of orthopedic surgery in the last six months per self-report
Quality Control of Cardiopulmonary Exercise Equipment

This study is designed to make sure exercise equipment used by the National Heart, Lung, and Blood Institute is working properly. Healthy volunteers will be requested to use P-CCMB cardiopulmonary exercise equipment (treadmills and exercise bicycles) two times a month to ensure the machines are functioning properly.

Proper functioning of recently acquired P-CCMB cardiopulmonary exercise equipment will be verified by testing healthy volunteers. In addition, quality control will be verified by performing monthly testing of healthy volunteers as biologic standards.

Eligibility Criteria:
INCLUSION:

Healthy research volunteers who are between 21 and 65 years.

EXCLUSION:

Patients with a history of ischemic or valvular heart disease.

Patients with history of chronic pulmonary disease.

Pregnant women.
Air Optix® Night and Day® Aqua Continuous Wear

The purpose of this retrospective, Post-Market Clinical Follow-Up (PMCF) study is to assess the long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as 30 days of continuous wear for vision correction.

This is a non-interventional/observational study designed as a retrospective chart review. Study sites will identify charts within their existing databases in a fair and consistent manner. Subjects/charts meeting the eligibility criteria will be enrolled in the study.

The study is designed with one period. The duration of the period includes the Baseline Visit and the Year 3 Visit as follows:

* The Baseline Visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject, before or during which a contact lens prescription for AONDA or PureVision 2 (PV2) was released.
* The Year 3 Visit is defined as a visit which occurred 3 years (-2/+8 months) since Baseline during which period the subject was wearing AONDA contact lenses or PV2 contact lenses and a contact lens examination was performed.

The data collection period is defined as any approximately 3-year timeframe since and including 2009.

Eligibility Criteria:
Key Inclusion Criteria:

* Manifest refraction cylinder less than or equal to 0.75 diopter in each eye at baseline
* Best corrected visual acuity of 20/25 or better in each eye at baseline
* At the time of Year 3 Visit, subject was prescribed and wearing AONDA or PV2 contact lenses in both eyes in a 30-day continuous wear modality for at least approximately 3 years
* Baseline Visit and Year 3 Visit charts available

Key Exclusion Criteria:

* Any recurrent history or active anterior segment infection, inflammation, abnormality, or disease contraindicating regular contact lens wear present at baseline
* The use of systemic or ocular medications contraindicating regular contact lens wear at baseline
* History of refractive surgery or irregular cornea
* Slit lamp findings, including signs of pathological dry eye, that would contraindicate regular contact lens wear at baseline