linjc16/ctgov huggingface dataset:
Vtama in Psoriasis Patients Being Treated With Biologics.

Study Overview
=================
Brief Summary
-----------------
Open label study to assess 12 weeks of add-on VTAMA® (tapinarof) Cream, 1% QD in patients with ≥3% BSA who have received biologic therapy for at least 24 weeks.

Official Title
-----------------
Open Label, Observational Study, Evaluating VTAMA® (Tapinarof) Cream, 1% QD in Psoriasis Patients Being Treated With Biologic Agents.

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Tapinarof


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female adult ≥ 18 years of age; Diagnosis of chronic plaque-type Patient with ≥3% BSA Patient has been treated with biologic for a minimum of 24 weeks Able and willing to give written informed consent prior to performance of any study-related procedures. Exclusion Criteria: ≤3% BSA Patient not receiving biologic agent, or receiving biologic agent <24weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Interventional Model Description: open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Vtama<br>open label Vtama | Drug: Tapinarof<br>* Add on Vtama (tapinarof) to biololgic therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body surface area ≤1% | Patients who achieve body surface area of ≤1% | 12 weeks |
NICE - Nutritional Impact on Immunological Maturation During Childhood in Relation to the Environment

Study Overview
=================
Brief Summary
-----------------
Role of the exposome on allergy, caries, and neurophysiological development in childhood.

Detailed Description
-----------------
Role of the exposome and epigenetics on allergy, caries, and neurophysiological development in childhood as studied in a birth cohort of 650 trioses. The exposome includes repeated measures of nutrition, micronutritients, microbiota, toxic agents and the clinical outcomes, diagnoses of allergy, caries and neurophysiological functions/dysfunctions.

Official Title
-----------------
NICE - Nutritional Impact on Immunological Maturation During Childhood in Relation to the Environment

Conditions
-----------------
Chronic Diseases in Children

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Born at Sunderby hospital, Region Norrbotten, during time period 2015-2018 Exclusion Criteria: Parents not able to speak or write Swedish

Ages Eligible for Study
-----------------
Maximum Age: 6 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with excema | Excema | Outcome at one year | 
| Number of participants with food allergy | Food allergy | Outcome at one year | 
| Number of participants with frhino-conjuctivitis | Rhino-conjunctivitis | Outcome at one year | 
| Number of participants with asthma | Asthma | Outcome at one year | 
| Number of participants with excema | Excema | Outcome at four years | 
| Number of participants with food allergy | Food allergy | Outcome at four years | 
| Number of participants with rhino-conjunctivitis | Rhino-conjuctivitis | Outcome at four years | 
| Number of participants with asthma | Asthma | Outcome at four years | 
| Number of participants with excema | Excema | Outcome at six years | 
| Number of participants with food allergy | Food allergy | Outcome at six years | 
| Number of participants with rhino-conjunctivitis | Rhino-conjunctivitis | Outcome at six years | 
| Number of participants with asthma | Asthma | Outcome at six years | 
| Numbers of caries lesions (DeMFS = decayed, enamel included, missed, filled, tooth surfaces, in each child | Cariesfree individuals have a DeMFS = 0 and increasing scores means increasing degree of caries. Maximum DeMFS = 148, minumum DeMFS = 0. | Outcome at four years | 
| Child cognition as measured by Wechsler Preschool and Primary Scale of Intelligence | Cognitive development will be tested face-to-face with Wechsler Preschool and Primary Scale of Intelligence. Increasing scores means increasing intelligence. | Outcome at four years |
A Clinical Model for Dialysis Discontinuation in AKI

Study Overview
=================
Brief Summary
-----------------
A retrospective study evaluating AKI patients in whom RRT was interrupted for at least 48 hours. Patients who were still RRT-independent 7 days after initial RRT cessation were included in the Success group, as opposed to the Failure group. Baseline characteristics and variables at the time of RRT interruption were collected. Multivariable analysis was performed and a model was generated to evaluate the prediction of success.

Official Title
-----------------
A Clinical Model to Predict Successful Renal Replacement Therapy (RRT) Discontinuation in Patients With Acute Kidney Injury (AKI)

Conditions
-----------------
Acute Renal Failure, Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients receiving kidney replacement therapy due to AKI from October 2020 to February 2022 were considered for inclusion in the study. Patients who managed to remain at least 48 consecutive hours without receiving kidney replacement therapy prescription were included. Exclusion Criteria: Patients who had kidney replacement therapy interrupted exclusively due to haemodynamic instability, death or decision for palliative care were excluded.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Success<br>Patients who were alive and free from RRT 7 days after interrupting RRT. | |
| Failure<br>Patients who were not alive or who needed to dialyse again after interrupting RRT for at least 48h. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success in RRT discontinuation | To be alive and free from RRT 7 days after interrupting RRT. | 7 days |
A Trial of HRS-1893 in Healthy Volunteers and Patients With Obstructive Hypertrophic Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this phase Ⅰ study is to evaluate the safety, tolerability and pharmacokinetics of HRS-1893 in healthy volunteers and patients with obstructive hypertrophic cardiomyopathy

Official Title
-----------------
A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effects of Food on the Pharmacokinetics of HRS-1893 Tablets After Single and Multiple Ascending Oral Doses in Healthy Volunteers and Patients With Obstructive Hypertrophic Cardiomyopathy

Conditions
-----------------
Obstructive Hypertrophic Cardiomyopathy

Intervention / Treatment
-----------------
* Drug: HRS-1893
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF) Male or female aged 18-55（adult healthy volunteers）or 18-85 (oHCM patients). Body mass index (BMI) between 19 and 28 kg/m2. Normal Electrocardiogram (ECG) Exclusion Criteria: History of persistent tachyarrhythmia and syncope; A history of stomach or bowel surgery or excision (e.g. appendectomy, hernia repair, and/or cholecystectomy); Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Parallel Assignment
Interventional Model Description: HRS-1893 compared with placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HRS-1893 for single ascending dose (SAD) cohorts<br>Subjects will be assigned to one of 6 planned dose cohorts and receive single dose of HRS-1893 | Drug: HRS-1893<br>* subcutaneous, single dose, multiple doses<br>|
| Placebo Comparator: Placebo comparator for SAD cohorts<br>Subjects will be assigned to one of 6 planned dose cohorts and receive single dose of placebo comparator | Drug: Placebo<br>* subcutaneous, single dose, multiple doses<br>|
| Experimental: HRS-1893 for multiple ascending dose (MAD) cohorts<br>Subjects will receive multiple doses of 2-4 planned dose cohorts and receive single dose of placebo comparator for MAD cohorts | Drug: HRS-1893<br>* subcutaneous, single dose, multiple doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of adverse event (AE), serious adverse event (SAE) |  | Start of Treatment to end of study (approximately 34 days) |
Quality of Life in Traumatic Brain Injury Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to describe the quality of life of CT patients in our study, at least 6 months after the occurrence of the trauma. This assessment is related to the patient's degree of sequelae, using the GOSE scale.

Detailed Description
-----------------
The assessment of patients quality of life would appear to be a particularly relevant tool in the ongoing drive to improve the quality of care. Thus, we should no longer simply assess how patients should feel, based on objective biomedical criteria, but how they actually perceive themselves, based on subjective criteria. This is particularly true in the case of traumatic brain injury , which is a high-incidence pathology with significant morbidity and mortality consequences that can lead to permanent sequelae . While research over the past 30 years has focused on the neuropsychological and functional outcomes of this event, less is known about the views of head injury survivors and their families on their quality of life, subjective well-being and related factors. The aim of this study is to describe the quality of life of CT patients at least 6 months after the trauma. This assessment is related to the patient's degree of sequelae, using the Glasgow Outcome Scale Extended GOSE.

Official Title
-----------------
Quality of Life in Traumatic Brain Injury Patients: Assessment at Discharge From an Intensive Care Unit.

Conditions
-----------------
All Adult Patients Admitted to theHMPIT ICU for Management of Head Trauma

Intervention / Treatment
-----------------
* Other: quality of life


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients (age 18 or over) admitted to the HMPIT intensive care unit for management of head trauma (isolated or as part of a polytrauma). Exclusion Criteria: Patients lost to follow-up after discharge. Incomplete ICU medical records. Patients or their families who refused to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A bras actif<br> | Other: quality of life<br>* To describe the relationship between distant sequelae of trauma assessed by the GOSE scale and quality of life<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life in patients with BI / The short form12 SF12 questionnaire | To describe the relationship between distant sequelae of trauma assessed by the GOSE scale and quality of life in patients with BI. | 6 month |
The Ability Of Inferior Vena Caval Distensibility Index With Passive Leg Raising Test To Predict Spinal Anesthesia-induced Hypotension In Elderly Patients Undergoing Infra-umbilical Surgeries. A Prospective Observational Study.

Study Overview
=================
Brief Summary
-----------------
Many previous studies have investigated the ability of various methods such as passive leg raising test , and inferior vena cava collapsibility index in predicting post-spinal hypotension, but none of them have succeeded in obtaining a good predictive value. Our study aims to combine the passive leg raising test with the inferior vena cava distensibility index to aid in predicting post-spinal hypotension in elderly undergoing infra-umbilical surgeries.

Official Title
-----------------
The Ability Of Inferior Vena Caval Distensibility Index With Passive Leg Raising Test To Predict Spinal Anesthesia-induced Hypotension In Elderly Patients Undergoing Infra-umbilical Surgeries. A Prospective Observational Study.

Conditions
-----------------
Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. 65 years of age or more. 2. ASA score I & II. 3. Patients are scheduled for infra umbilical surgeries under spinal anesthesia. Exclusion Criteria: Negative consent. Pre-existing hypertension Diabetes mellitus or autonomic neuropathy (patients diagnosed with autonomic neuropathy or having suggestive symptoms such as orthostatic hypotension, syncopal attacks, decreased sweating, and urinary incontinence) Emergency operations Absolute contraindications or failure to perform spinal anesthesia If PLR maneuver is contraindicated (intracranial hypertension) or possibly unreliable ( venous compression stocking, intraabdominal hypertension) Difficulties in IVC visualization due to increased subcutaneous fat tissue or gastric gas interferin

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 100 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity of Δmax.IVCd in predicting post-spinal anesthesia hypotension in elderly patients. | The incremental changes of measured maximum inferior vena caval diameter after passive leg raising | 15 minutes before spinal anesthesia |
Nurses Caring for Patients With Covid-19

Study Overview
=================
Brief Summary
-----------------
The main goal of this study was to understand the perceptions of nurses who cared for patients with Covid-19 at the onset of the pandemic in Northeast USA. Private interviews were held three times with each participant, over the period of 18 months. The interviews were examined for common themes and expressions used by nurses to describe such topics as their professional image, memories, and advise to other nurses.

Detailed Description
-----------------
This study was conducted in a single institution. Forty-one (41) nurses were recruited from various units in the medical center. An effort was made to invite nurses from different clinical units, as well as inexperienced and experienced nurses, and males as well as females. To obtain variety in the participants a randomization list (list of names placed in order by a computer) was used to invite nurses. Participants consented and were aware that they would be interviewed three times. The interviews were recorded for transcription and subsequent analysis.

Official Title
-----------------
A Longitudinal Study of Clinical Nurses Caring for Hospitalized Adults With Covid -19

Conditions
-----------------
Nurse, in Northern New Jersey, Providing Care to Adults With Covid-19

Intervention / Treatment
-----------------
* Other: Qualitative (interviews)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: RN employed by facility; cared for adult patients with Covid-19 from March - April 2000, consenting Exclusion Criteria: not employed as an RN; did not care for patients with Covid-19 from March-April 2000 at designated facility, does not agree to consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Qualitative (interviews)|Interviews were held with participants at three different time points, approximately six months apart. Interviews were taped and analyzed for common themes.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A longitudinal study of clinical nurses caring for hospitalized adults with Covid -19 | 41 nurses were interviewed three times to explore perceptions of caring for patients with Covid-19 | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nurses, interviews, caring for patients with Covid-19
AT278, NovoRapid® and Humulin® R (U500) in Glucose Clamp Study

Study Overview
=================
Brief Summary
-----------------
This is a phase 1, single dose, randomised, double-blind, two-way crossover study to compare ultra-rapid-acting concentrated insulin aspart AT278 (U500/mL) with standard insulin aspart NovoRapid® (U100/mL) in participants with T2D. Participants and Investigators will be blinded to both study interventions. Humulin® R U-500 (U500/mL), a highly concentrated regular human insulin, will be used as an open-label comparator.

Official Title
-----------------
A Phase 1, Single Centre, Single Dose, Randomised, Double-blind, Two-way Crossover, Glucose Clamp Study Investigating the Pharmacodynamics, Pharmacokinetics, and Safety of Ultra-rapid-acting Concentrated Insulin Aspart AT278 in Comparison to Standard Insulin Aspart NovoRapid® With an Additional Open Comparison to Humulin® R U-500 in Participants With Type 2 Diabetes.

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: AT278
* Drug: NovoRapid
* Drug: Humulin R 500 UNT/ML Injectable Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of type 2 diabetes for at least 180 days prior to the day of screening Haemoglobin A1C (HbA1c) concentration of ≤9.5% (≤80 mmol/mol) at screening. BMI within the range of 25 - 45 kg/m2 (both inclusive) Exclusion Criteria: Known or suspected hypersensitivity to IMPs or related products Clinically significant concomitant disease or abnormal lab values Severe asthma or chronic obstructive pulmonary disease (GOLD III and IV), or lower if requiring high dose of corticosteroids or beta2-adrenergic agonists

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AT278<br>Single subcutaneous injection of 0.5 U/kg | Drug: AT278<br>* Concentrated rapid acting insulin aspart<br>Drug: NovoRapid<br>* Rapid-acting insulin aspart<br>Drug: Humulin R 500 UNT/ML Injectable Solution<br>* Regular human insulin<br>|
| Active Comparator: NovoRapid<br>Single subcutaneous injection of 0.5 U/kg | Drug: AT278<br>* Concentrated rapid acting insulin aspart<br>Drug: NovoRapid<br>* Rapid-acting insulin aspart<br>Drug: Humulin R 500 UNT/ML Injectable Solution<br>* Regular human insulin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the glucose infusion rate-time curve of insulin aspart |  | 0 to 60 minutes |
Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of Atroshi-Lyrén 6-item Symptoms Scale

Study Overview
=================
Brief Summary
-----------------
This study aims to develop Turkish version of the Atroshi-Lyrén 6-item symptoms scale (A-L scale) and to perform validity and reliability evaluations.

Official Title
-----------------
Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of Atroshi-Lyrén 6-item Symptoms Scale

Conditions
-----------------
Carpal Tunnel Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 18-65 years old, Had symptoms of numbness, tingling, weakness and pain in the hands for at least 1 month, Assessed through provocation tests and physical examination to match the median nerve distribution. Exclusion Criteria: Not willing to participate in the study, Clinical or electrophysiological signs of proximal nerve compression, Diabetes or other metabolic disease, Rheumatoid arthritis or other general inflammatory diseases.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Healthy Controls<br>Healthy individuals aged between 18-65 years old | |
| CTS Group<br>CTS patients aged between 18-65 years old | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atroshi-Lyrén 6-item symptoms scale | The A-L scale consists of 6 items that inquire about severity and frequency of night and daytime numbness and tingling and pain. For each patient the item responses are scored from 1 (best) to5 (worst) and then averaged for the 6 items to yield a total score (only 1 missing item response is allowed) | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carpal Tunnel Syndrome, Pain