linjc16/ctgov huggingface dataset:
A Pilot Study to Explore the Role of Gut Flora in Psoriasis

Study Overview
=================
Brief Summary
-----------------
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Psoriasis.

Detailed Description
-----------------
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Psoriasis

Official Title
-----------------
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Psoriasis

Conditions
-----------------
Psoriasis, Psoriasis Vulgaris, Psoriasis Universalis, Psoriasis Face, Psoriasis Nail, Psoriatic Plaque, Psoriasis Diffusa, Psoriasis Punctata, Psoriasis Palmaris, Psoriasis Circinata, Psoriasis Annularis, Psoriasis Genital, Psoriasis of Scalp, Psoriasis Geographica

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent by patient Male or female patients age 18 and older. Diagnosis of Psoriasis based on PSAI of greater than or equal to 12 at screening Exclusion Criteria: Refusal by patient to sign informed consent form Treatment with antibiotics within 2 weeks prior to screening Treatment with probiotics within 6 weeks prior to screening History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. Postoperative stoma, ostomy, or ileoanal pouch Participation in any experimental drug protocol within the past 12 weeks Treatment with total parenteral nutrition Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

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 |
| --- | --- |
| Psoriasis patients<br>Patients who have been diagnosed with Psoriasis | Other: No Intervention<br>* There is no intervention for this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Microbiome to Psoriasis via Relative Abundance Found in Microbiome Sequencing | Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be correlated with specific Psoriasis types | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of Sequencing Methods | To validate the methods used to sequence samples | 1 year |
Diagnosing Acute Onset Insufficient Intestinal Blood Flow (Bowel Ischemia) With a Novel CT Technique Called Dual-energy CT (DECT). This Observational Study Seeks to Evaluate Whether DECT Can Improve the Diagnosis of Bowel Ischemia and How the DECT Findings Correlate With Intraoperative Findings

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the performance of dual-energy CT (DECT) in the diagnosis of acute bowel ischemia (ABI). ABI is a condition characterised by inadequate blood supply to portions of the intestine. ABI is a relatively rare condition, but is associated with a high mortality rate. DECT is an emerging field within radiology. Few reports have reported an increased conspicuity for ABI using DECT compared with conventional CT, which is the current preoperative golden standard. The investigators hypothesize that DECT increases conspicuity of ABI compared with conventional CT and that DECT image findings correlate with the intraoperative findings.

Official Title
-----------------
Dual-energy CT in the Diagnosis of All-Cause Acute Bowel Ischemia

Conditions
-----------------
Bowel Ischemia, Acute Bowel Ischemia / Infarction

Intervention / Treatment
-----------------
* Diagnostic Test: Dual-energy CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referred on the suspicion of acute bowel ischemia Exclusion Criteria: Patient not scanned with DECT Patient does not undergo abdominal surgery
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Dual-energy CT|Patients suspected of acute bowel ischemia will be scanned in the dual-energy CT scanner. The abdominal imaging protocols are predetermined by the Department of Diagnostic Radiology, Righospitalet, Denmark.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adding DECT information increases assessor confidence without lowering the specificity compared with standard CT in the diagnosis and/or exclusion of ABI. |  | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative ICG fluorescence angiogram perfusion assessment and its correlation to DECT image evaluation. |  | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dual-energy CT
A Single-Center, Exploratory Study to Analyze the Dynamics of Skin Microflora Following Exposure to Surfactants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand the changes in skin microflora, skin barrier function, and skin biochemical constituents in response to direct contact with model surfactants used in personal care articles. The results from this study will provide insights into the complex interaction between the skin microbiome and the epidermis after exposure to surfactants.

Official Title
-----------------
A Single-Center, Exploratory Study to Analyze the Dynamics of Skin Microflora Following Exposure to Surfactants

Conditions
-----------------
Dermatitis

Intervention / Treatment
-----------------
* Other: PEG-40 Hydrogenated Castor Oil (Tagat CH40, Evonik) 1.5%
* Other: Lauryl glucoside (Plantacare® 1200UP, BASF) 1.5%
* Other: Sorbitan palmitate (SPANTM 40 (powder), Croda) 1.5%
* Other: Silwet* DA-63 (Momentive) 1.5%
* Other: Sodium lauryl sulfate (Sigma Aldrich) 1.0%
* Other: Water (control)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Subjects with Fitzpatrick Skin Types I, II or III Exclusion Criteria: Subjects with visible skin disease, tattoos, skin condition, or abnormal skin color

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Surfactant Exposure<br>PEG-40 Hydrogenated Castor Oil (Tagat CH40, Evonik) 1.5% Lauryl glucoside (Plantacare® 1200UP, BASF) 1.5% Sorbitan palmitate (SPANTM 40 (powder), Croda) 1.5% Silwet* DA-63 (Momentive) 1.5% Sodium lauryl sulfate (Sigma Aldrich) 1.0% Water | Other: PEG-40 Hydrogenated Castor Oil (Tagat CH40, Evonik) 1.5%<br> <br> Other: Lauryl glucoside (Plantacare® 1200UP, BASF) 1.5%<br> <br> Other: Sorbitan palmitate (SPANTM 40 (powder), Croda) 1.5%<br> <br> Other: Silwet* DA-63 (Momentive) 1.5%<br> <br> Other: Sodium lauryl sulfate (Sigma Aldrich) 1.0%<br> <br> Other: Water (control)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of microbes present on skin after exposure to various surfactants | Microbes will be identified by metagenomic sequencing | 4 days | 
| Amount of microbes present on skin after exposure to various surfactants |  | 4 days |
Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in North America. The aim of this trial is asses the long term safety and efficacy of biphasic insulin aspart 30 in Canadian subjects with type 2 diabetes who had participated in the BIAsp-1237 trial.

Official Title
-----------------
A Multi-centre, Non-comparative, Open-labelled, Extension Trial to Assess the Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes (Extension to BIAsp-1237)

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

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed the BIAsp-1237 trial

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIAsp 30<br> | Drug: biphasic insulin aspart 30<br>* Dose individually adjusted. Injected twice daily immediately before breakfast and dinner. Administrated subcutaneously (s.c., under the skin)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events |  |  | 
| Occurence of hypoglycaemic episodes |  |  |
Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis

Study Overview
=================
Brief Summary
-----------------
The objective is to evaluate the dietary nitrogen assimilation and metabolic utilisation capability of patients with chronic pancreatitis.

Official Title
-----------------
Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis

Conditions
-----------------
Chronic Pancreatitis

Intervention / Treatment
-----------------
* Drug: Creon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects with chronic pancreatitis and taking enzyme replacement therapy Exclusion Criteria: patients with hepatic impairment patients allergic to dairy proteins urinary incontinence affecting the measurement of nitrogen metabolism digestive disorder affecting the absorption of nutrients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Creon|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure digestive and metabolic assimilation of dietary proteins in patients with chronic pancreatitis |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the efficacy of enzyme therapy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic pancreatitis, exocrine pancreatic insufficiency, enzyme therapy, patients with chronic pancreatitis and exocrine pancreatic insufficiency, taking enzyme replacement therapy
Rehabilitation of Young Patients With Rheumatic Diseases in a Warm Climate

Study Overview
=================
Brief Summary
-----------------
Young patients with rheumatic diseases have challenges different from older patients due to their life situation. It has been reported that they do not have the same benefit from age non-specific rehabilitation in warm climate. This trial will test the effect of a specially adapted version of a rehabilitation program delivered in Spain (warm climate) for Norwegian young adults aged 20-35 years.

Official Title
-----------------
Effect of Rehabilitation of Young Patients With Rheumatic Diseases in a Warm Climate. A Pilot Randomised Controlled Trial

Conditions
-----------------
Rheumatic Diseases

Intervention / Treatment
-----------------
* Other: Rehabilitation in warm climate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inflammatory rheumatic disease Self reliant in daily life Exclusion Criteria: - conditions that might influence ability to fly to Spain and participate in rehabilitation in warm climate (Unstable heart disease, Serious lung disease, Chronic open ulcers, Serious mental health conditions, alcohol or drug addiction, Intolerant of sun and heat)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Climate therapy<br>Climate therapy consisting of 3 week stay at rehabilitation facility in Spain | Other: Rehabilitation in warm climate<br> <br> |
| No Intervention: Usual care<br>Usual care provided as needed / agreed between patient and health care providers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coping (Effective Consumer Scale (EC17) | Measured with Effective Consumer Scale (EC17) | 12 months | 
| 30 second sit to stand test |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ5D |  | 12 months | 
| Numerical Rating Scales (NRS) fatigue question |  | 12 months | 
| Hannover functional Scale |  | 12 months | 
| Coop Wonca |  | 12 months | 
| Hopkins Symptom Checklist |  | 12 months | 
| Patient Specific Functional scale |  | 12 months | 
| Numerical Rating Scales (NRS) pain question |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Climatotherapy
Radiological Measurement of Femoral Stem Version Using Lateral Decubitus Method: A Prospective Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to develop a radiological method to measure stem anteversion and to determine its validity and reliability.

Detailed Description
-----------------
Version of the femoral stem is an important factor influencing the risk of dislocation after total hip replacement (THR) as well as the position of the acetabular component. However, there is no radiological method of measuring stem anteversion described in the literature. Investigators propose a radiological method to measure stem version and have assessed its reliability and validity. In 40 patients who underwent THR, a hip radiograph and CT scan were taken to measure stem anteversion.

Conditions
-----------------
Arthroplasty, Total Hip Replacement

Intervention / Treatment
-----------------
* Radiation: Radiological measurement of femoral stem version


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Investigators recruited 40 consecutive patients who underwent THR between October 2015 and December 2015 Exclusion Criteria: patients who could not extend the hip because of a residual flexion contracture. who had a flexion contracture of the knee or who could not flex the hip to 90° even after THR were excluded because participants could not adopt the posture required for the particular radiographs and CT scans.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| stem anteversion<br>a hip lateral radiograph and CT scan were taken to measure stem anteversion | Radiation: Radiological measurement of femoral stem version<br>* particular radiographs( lateral decubitus view) and CT scans<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stem anteversion of the hip radiograph(decubitus lateral view) |  | postoperative 4days | 
| stem anteversion of the CT scan |  | postoperative 4days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation between stem anteversion of the decubitus lateral view and stem version of the CT scan | to determine ICC(intraclass coefficient, correlation coefficient) | postoperative 4days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
total hip, stem version, replacement, hip
Use of Black Cohosh and Red Clover for the Relief of Menopausal Symptoms

Study Overview
=================
Brief Summary
-----------------
This Phase II study, a follow-up to a Phase I trial in normal volunteers, will determine the efficacy of black cohosh and red clover for the relief of menopausal symptoms. It will also assess the safety of chronic dosing (1 year) by evaluating uterine (endometrial biopsies), breast (mammography), and hematology parameters (CBC and chemistry lab values) at baseline and 1 year.

Official Title
-----------------
Black Cohosh and Red Clover Efficacy for the Relief of Menopausal Symptoms

Conditions
-----------------
Hot Flashes, Menopause

Intervention / Treatment
-----------------
* Drug: Cimicifuga racemosa
* Drug: Trifolium pratense
* Drug: Black cohosh
* Drug: Red clover


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Menopausal women with intact uterus Must be experiencing hot flashes No menstrual periods for at least 6 months and no longer than 3 years Non-smoker Must have intact uterus (no hysterectomy) Exclusion Criteria: Contraindications for hormone replacement therapy Diabetes mellitus Pregnancy or breast-feeding Obese (BMI >35 excluded) History of endometrial hyperplasia/neoplasia/malignancy History of breast or reproductive cancer History of severe recurrent depression, or severe psychiatric disturbance History of stroke/CVA, severe varicose veins, sickle cell anemia, myocardial infarction (heart attack), or arrhythmia (rhythm disturbance of the heart) History of abnormal vaginal bleeding of unknown cause Untreated or uncontrolled high blood pressure/hypertension Use of any medication or supplement containing estrogen, progestin, SERM, St. John's Wort, bisphosphonates, or phytoestrogens History of hormone-associated migraines History of deep vein thrombosis (blood clots), thrombophlebitis, or thromboembolic disorders Participation in a clinical trial within 30 days Abnormal endometrial biopsy or mammogram Abnormal transvaginal ultrasound defined as >7mm thickness Vegan
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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cimicifuga racemosa|nan|
|Drug: Trifolium pratense|nan|
|Drug: Black cohosh|nan|
|Drug: Red clover|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
menopause, hot flashes, red clover, black cohosh, sexual dysfunction
Efficacy of Ciclesonide During the Cold Season in Patients Older Than 12 Years With Persistent Asthma

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the efficacy of ciclesonide in patients with persistent asthma over 3 months, especially in the cold season. Ciclesonide will be inhaled by a metered-dose inhaler. The study will provide further data on safety and tolerability of ciclesonide.

Official Title
-----------------
Ciclesonide for the Therapy of Asthma During the Cold Season.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Ciclesonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Main inclusion criteria: History of persistent bronchial asthma Main exclusion criteria: Hypersensitive to compounds of Alvesco Other criteria as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.3)

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Artist<br> | Drug: Ciclesonide<br>* This is an observational study. Therefore, the physician decides about dosage according to individual needs.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1, symptom score assessment |  | within 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Handling of the metered-dose inhaler, safety and tolerability |  | within 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, ciclesonide, inhaled steroids, Alvesco