linjc16/ctgov huggingface dataset:
Determination of Safety and Consumers' Satisfaction of Moussik Versus Desitin Creamy Ointment in Diaper Rash Prophylaxis

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical observation is to evaluate the safety and consumers' satisfaction of Moussik vs Desitin Creamy ointment as a diaper rash protection product.

Official Title
-----------------
A Clinical Observation to Assess the Safety and Consumers' Satisfaction of Moussik vs Desitin Creamy Ointment in Prophylaxis of Diaper Rash. A Single Blind, Multicenter, Randomized, Cross-over Study

Conditions
-----------------
Diaper Rash

Intervention / Treatment
-----------------
* Other: Moussik Diaper Rash Mousse
* Other: Desitin Creamy Ointment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female infants aged between 3-18 months who are routine users of disposable diapers Exclusion Criteria: Children with symptoms of systemic disease or skin lesions. Children diagnosed as having diaper dermatitis at baseline Known hypersensitivity to any of the components of the trial preparations. Children suffering from atopic diseases. Children who have participated during the last month in another clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 18 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Moussik Diaper Rash Mousse|To be used as instructed|
|Other: Desitin Creamy Ointment|To be used as instructed|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six point erythema skin grade | 0 - Normal skin + - Questionable erthema not covering entire area - Definite erythema - Erythema and induration - Vesiculation - Blister reaction | After two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (VAS) from 0 to 10 |  | After two weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diaper Dermatitis, Diaper Rash, Erythema
Different Techniques for Insertion of the ProSeal Laryngeal Mask Airway in Patients With Difficult Airway

Study Overview
=================
Brief Summary
-----------------
The ProSeal laryngeal mask airway (PLMA) is a new laryngeal mask device with a modified cuff to improve the seal and a drain tube to prevent aspiration and gastric insufflation. The manufacturer recommends inserting the PLMA using digital manipulation, like the Classic LMA, or with an introducer tool (IT), like the Intubating LMA. The mean (range) frequency of insertion success at the first attempt for these techniques is 84% (81-100) and 95% (90-100) respectively, with the main causes of insertion difficulty being impaction at the back of the mouth and failure of the distal cuff to reach the hypopharynx. Howarth et al described an insertion technique which overcomes these difficulties by using a gum elastic bougie (GEB) placed in the esophagus to guide the PLMA around the back of the mouth and into its correct position in the hypopharynx. Howarth et al reported no failed uses from 100 consecutive insertions. In the following study, we test the hypothesis that GEB-guided insertion is more frequently successful than the digital and IT techniques in patients with difficult airway.

Official Title
-----------------
Different Techniques for Insertion of the ProSeal Laryngeal Mask Airway in Patients With Difficult Airway

Conditions
-----------------
Difficult Airway, Ventilation

Intervention / Treatment
-----------------
* Device: ProSeal LMA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patient 19-70 yr Body mass index <35 kg/m2 Difficult airway Exclusion Criteria: < 19 yr Body mass index >35 kg/m2 Risk of aspiration

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ProSeal LMA|GEB vs digital vs introducer tool|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insertion success rate |  | 5 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to successful insertion |  | 5 min |
Physical Activity With Social Support Adherence Intervention

Study Overview
=================
Brief Summary
-----------------
The study compares two programs to increase physical activity among sedentary old persons. The first is a provision of a free physical activity program tailored to their abilities. The other combines the same free physical activity with an adherence intervention which focuses on social contact with others in the program and on enhancing self-efficacy.

Official Title
-----------------
Enhancing Physical Activity With a Social Support Adherence Intervention

Conditions
-----------------
Sedentary Status of Older Adults

Intervention / Treatment
-----------------
* Behavioral: PA+Social Adherence Intervention(PASAI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sedentary older adults. Residents in congregate housing. Exclusion Criteria: Age under 70. Not completing an informed consent form.

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Physical Activity (PA)<br>Physical activity (PA) involved a program of physical exercise alone. | |
| Active Comparator: PA+Social Adherence Intervention(PASAI)<br>PA+Social Adherence Intervention(PASAI) involved a program of physical exercise combined with a social adherence intervention. | Behavioral: PA+Social Adherence Intervention(PASAI)<br>* While both physical activity programs were tailored to match participants' physical needs and abilities, the PA+Social Adherence Intervention(PASAI) introduced elements to promote and strengthen self-efficacy and social interaction among participants.<br>* Other names: Physical Activity (PA);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in the Rapid Assessment of Physical Activity (RAPA). | RAPA is an easily administered nine item questionnaire developed to assess physical activity levels among older adults. | Baseline and Three Months. |
Post Lumbar Radiofrequency Neurotomy Imaging

Study Overview
=================
Brief Summary
-----------------
MRI imaging post radio frequency ablation procedure for facet arthritis

Detailed Description
-----------------
This study is an imaging study. Following a radio frequency ablation procedure for facet arthritis low back pain the patient can join the imaging study. During the study the patient undergo contrast enhanced MRI imaging of the lumbar spine Once the imaging is done the patient finishes the study

Official Title
-----------------
Post Lumbar Radiofrequency Neurotomy Imaging

Conditions
-----------------
Facet Joint Pain

Intervention / Treatment
-----------------
* Other: no intervention, imaging study only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male and females, legally able and willing to participate in the study Able and willing to complete the research questionnaires and communicate with the investigator and research team Patients who are scheduled to have bilateral or unilateral treatment by radiofrequency neurotomy for chronic lumbar pain. Exclusion Criteria: Pregnant or breastfeeding patient Patients younger than 18 Patients unable to understand and complete the research questionnaires in English Patient with any contraindication for MRI contrast agents - Patients with known intolerance or allergies to the MRI contrast agent (e.g., Gadovist) including advanced kidney disease Patients with a pacemaker, implanted defibrillator or internal pacing wires. Patient with mechanical heart valve Patient with an aneurysm clip Patient with eye surgery or injury involving a metallic object Patient with ear surgery or implanted device to the ear Patient with any implanted electrical, metallic or magnetic device such as implanted neurostimulator, implanted drug infusion pump or bone growth stimulator Patient with any kind of prosthesis (Eye, Ear, Penile, limb), or any other metal in your body from surgery or injury Patient with vascular clamp, filter, coil or stent Pregnant or breast-feeding patient Patient with anemia, liver disease or history of MRI contrast reaction Patient with any known kidney disease, prior kidney surgery or on dialysis Patient with hypertension or diabetes that requires medication Patient with any metal in or on their body (example: shrapnel, BB's, Tattoos, permanent makeup) Patients who are claustrophobic or known adverse psychological reactions with previous MRI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention, imaging study only|Imaging study only|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI imaging of the lumbar spine | MRI imaging of the lumbar spine | Up to 5 days after the RFA procedure (which was done before the study) |
Effect of Age on the Median Effective Concentration(EC50) for Motor Block With Spinal Plain Bupivacaine

Study Overview
=================
Brief Summary
-----------------
This study was performed in 131 adult patients undergoing transurethral, urological or lower limb surgery under combined spinal and epidural anesthesia. Patients were stratified according to age: 20-30, 31-40, 41-50, 51-60, 61-70, and 71-80 years. The spinal component of the anesthetic was established by bolus administration of up-and-down doses of 0.75% plain bupivacaine, determined by Dixon's method. The degree of motor block after intrathecal administration of each concentration was evaluated by the modified Bromage and Hip motor function score. The EC50 were estimated from the up-and-down sequences using the method of Dixon and Massey and logistic regression. Other endpoints were included on the basis of sensory block level, duration of motor blockade, hypotension, and vasopressor requirements.

Official Title
-----------------
Effect of Age on the Median Effective Concentration(EC50) for Motor Block With Spinal Plain Bupivacaine

Conditions
-----------------
Mononeuropathy of the Median Nerve, Mild

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - ASA physical status I-II adult patients who were undergoing transurethral, urological or lower limb surgery, primarily under the spinal component of established combined epidural-spinal anesthesia, with the epidural component to be used if there was a need for intra-operative analgesic supplementation or for postoperative analgesia. Exclusion Criteria: Patients with diabetes, obesity, neuromuscular diseases, bleeding diathesis, hypersensitivity to amide local anesthetics, lumbar vertebrae abnormality, chronic back pain, or who were pregnant were excluded from this study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the median effect concentration of bupivacaine | The endpoint was determined according to the degree of motor power in any lower limb (according to the modified Bromage scale and the Hip motor function scale) within 5 minutes after intrathecal administration of the tested bupivacaine concentration | The endpoint was determined according to the degree of motor power in any lower limb (according to the modified Bromage scale and the Hip motor function scale) within 5 minutes after intrathecal administration of the tested bupivacaine concentration | 
| sensory block level | the sensory level was assessed by the pinprick or ice at interval 5 minutes and 2 0minutes after injection of spinal bupivacaine. | 20 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intrathecal;, bupivacaine;, concentration;
Pilot Study to Clinical Evaluate Device Prototypes in Dry Eye Patients

Study Overview
=================
Brief Summary
-----------------
The study will assess the safety, tolerability and feasibility of Lacrima investigational medical device to treat dry eye patients

Official Title
-----------------
Pilot, Open-label, Single-Arm Study Designed to Clinically Evaluate Various Lacrima Medical Device Prototypes in Adult Patients With Dry Eye Syndrome

Conditions
-----------------
Dry Eye Syndrome

Intervention / Treatment
-----------------
* Device: Lacrima medical Prototypes


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Male or female, 18 years of age and over at screening Diagnosis of mild to moderate Dry Eye, as defined by: Positive corneal fluorescein staining , defined as a corneal punctate fluorescein staining score of ≥3 in either eye by the National Eye Institute evaluation scale summed over 5 areas, each with a 0-3 scoring scale; AND Schirmer Test score (with anesthesia, 5 minutes < 5 mm either eye) ; AND OSDI score of ≥12 and OSDI score of <33 Main Exclusion Criteria: Persistent intraocular inflammation or infection including conjunctivitis at the time of the study or 2 weeks prior to study start. Any concomitant active or history of eye disease including, but not limited to lid abnormalities, nasolacrimal obstruction, active ulcer, glaucoma or ocular herpes simplex virus infection Patients currently using topical steroidal or anti-inflammatory eye drops for 1 month prior to screening Receipt of any type of topical artificial eye drops within 3 days prior to screening Receipt of topical cyclosporine eye drops within 3 months prior to screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with Lacrima medical device<br> | Device: Lacrima medical Prototypes<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower Tear Meniscus Height using Optical Coherence Tomography |  | up to 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale score |  | up to 8 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Keratoconjunctivitis Sicca, Dry Eye Syndromes
Lay Therapist Effectiveness With Displaced Persons Kurdish Iraq

Study Overview
=================
Brief Summary
-----------------
Negative mental health effects of war exposure and displacement are pervasive, but many displaced persons and refugees in low-and-middle income countries lack access to evidence-based treatments. Community lay-therapists are a promising solution for the global mental health field. However, in spite of results from randomized-control trials, no research to-date has examined the external validity of community-led lay-therapist effectiveness. In this exploratory study, longitudinal data at three time points were collected from 28 Arabic-speaking displaced persons (nineteen women and nine men, ages 18-57) seeking mental health services from the Jiyan Foundation: a non-profit founded and based in Kurdish Iraq. Lay therapists trained in evidence-based treatments upon being hired operated largely independently of supervision from foreign clinicians. Participants in weekly psychotherapy completed the Posttraumatic Stress Checklist (PCL-5) and the Psychological Health Questionnaire (PHQ-9) at baseline, one month, and three months, as well as a modified measure assessing traumatic exposure, purpose-in-life, and a modified Afghan Daily Stressors Scale at baseline to assess for moderators of change over time.

Official Title
-----------------
Lay Therapist Effectiveness With Displaced Persons Kurdish Iraq: Promising Exploratory Results for Global Mental Health Access

Conditions
-----------------
Mental Health, Therapeutics

Intervention / Treatment
-----------------
* Behavioral: Community Lay Therapist-Administered EBT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must speak Arabic fluently; must be seeking mental health services at the Jiyan Foundation Exclusion Criteria: No Arabic proficiency; under 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment Group<br>Participants seeking treatment completed longitudinal data | Behavioral: Community Lay Therapist-Administered EBT<br>* Community Therapists Used CBT and EMDR Interventions<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Symptoms | Measured by the PCL-5 | 3 months | 
| Depression Symptoms | Measured by the PHQ-9 | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
evidence-based treatments, refugee, lay therapists, global mental health
Study Evaluating the Safety, Tolerability, and Pharmacokinetics (PK) of HKI-357 Administered Orally to Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single doses of HKI-357 administered to healthy subjects.

Official Title
-----------------
Ascending Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of HKI-357 Administered Orally to Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: HKI-357


Participation Criteria
=================
Eligibility Criteria
-----------------
Eligibility Criteria: Healthy adult men or women of nonchildbearing potential, aged 18-50.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>10mg | Drug: HKI-357<br>* Single-dose capsule<br>|
| Placebo Comparator: 2<br>20mg | Drug: HKI-357<br>* Single-dose capsule<br>|
| Placebo Comparator: 3<br>40mg | Drug: HKI-357<br>* Single-dose capsule<br>|
| Placebo Comparator: 4<br>80mg | Drug: HKI-357<br>* Single-dose capsule<br>|
| Placebo Comparator: 5<br>160mg | Drug: HKI-357<br>* Single-dose capsule<br>|
| Placebo Comparator: 6<br>240mg | Drug: HKI-357<br>* Single-dose capsule<br>|
| Placebo Comparator: 7<br>400mg | Drug: HKI-357<br>* Single-dose capsule<br>|
| Placebo Comparator: 8<br>640mg | Drug: HKI-357<br>* Single-dose capsule<br>|
| Placebo Comparator: 9<br>960mg | Drug: HKI-357<br>* Single-dose capsule<br>|
| Placebo Comparator: 10<br>placebo | Drug: HKI-357<br>* Single-dose capsule<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, tolerability, PK |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy subjects