linjc16/ctgov huggingface dataset:
Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
this study is to evaluate the potential of DSXS to suppress HPA axis function in patients with moderate to severe atopic dermatitis.

Detailed Description
-----------------
The objective of this study is to evaluate the potential of DSXS to suppress HPA axis function in patients with moderate to severe atopic dermatitis. The secondary objectives are to evaluate to evaluate adverse event (AE) profiles of DSXS administered to patients with moderate to severe atopic dermatitis.

Official Title
-----------------
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression and Pharmacokinetics Following Maximal Use Treatment With DSXS in Patients With Atopic Dermatitis.

Conditions
-----------------
Dermatitis, Atopic

Intervention / Treatment
-----------------
* Drug: DSXS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a definite clinical diagnosis of stable atopic dermatitis Exclusion Criteria: Patient is under the age of 2

Ages Eligible for Study
-----------------
Minimum Age: 2 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: DSXS topical product<br>treatment with DSXS twice daily for 28 days | Drug: DSXS<br>* Active treatment<br>* Other names: Active;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With HPA Axis Suppression | Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression at the end of treatment. HPA Axis suppression is defined as a 30 minute post CortrosynTM injection level cortisol level of ≤ 18 mcg/100ml. | 28 days. |
The Role of Therapeutic Drug Monitoring in Tuberculosis - a Pilot Study

Study Overview
=================
Brief Summary
-----------------
Drug resistant TB is increasing and in order to enchance the efficacy of the current drugs, individualized therapy using plasma drug concentrations and minimal inhibitory concentration (MIC) determination may be of importance. This concept is defined as therapeutic drug monitoring (TDM). In this pilot study our hypothesis is that the ratio between MIC and drug concentration data is correlated to the bacterial load measured as time to positive liquid culture (TTP). In two sites in Sweden (Linköping and Karolinska Hospital Solna, Stockholm), 25 patients with pulmonary tuberculosis will be recruited. MIC-determination of Mycobacterium tuberculosis will be performed in BACTEC 960 MGIT and drug concentration will be determined at 2, 4 and 12 weeks after treatment initiation using LC-MS/MS methodology. Sputum cultures will be obtained at 0, 2 days, 7 days, 2 weeks, 4 weeks and 8 weeks and TTP will be measured in duplicate samples. Clinical follow up according to WHO criteria will be performed 1 year after completion of treatment.

Official Title
-----------------
The Role of Therapeutic Drug Monitoring in Tuberculosis - a Pilot Study

Conditions
-----------------
Active Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 years, culture verified tuberculosis Exclusion Criteria: Other infectious diseases other than HIV or tuberculosis

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Rifampicin concentration in relationship to MIC over 10 |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate on Clinical follow up (according to WHO criteria) in relation to rifampicin concentration at week 2 |  | 1 year | 
| Sputum Culture conversion in relation to rifampicin, isoniazid and pyrazinamid concentration week 2 |  | 2 and 8 weeks | 
| TB-score in relation to rifampicin, isoniazid and pyrazinamid concentration week 2 |  | 8 weeks | 
| Time to positive Culture (TTP) in relation to isoniazid, ethambutol and pyrazinamid serum concentration and minimal inhibitory concentration (MIC) |  | 2 and 8 weeks | 
| Time to positive Culture (TTP) in relation to rifampicin serum concentration and minimal inhibitory concentration (MIC) |  | 2weeks |
Long Term Effects of a Structured Lifestyle Program

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was to describe a structured intervention to reduce cardiovascular risk in a clinical setting and to study the effects of the program on lifestyle habits and quality of life in individuals at risk after six months and one year.

Official Title
-----------------
Long Term Effects on Lifestyle Habits and Quality of Life in Individuals With Increased Cardiometabolic Risk Participating in a Structured Lifestyle Intervention Program

Conditions
-----------------
Lifestyle, Quality of Life

Intervention / Treatment
-----------------
* Behavioral: Longterm effects after a structured lifestyle program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: (three risk factors ) cardiovascular disease physical inactivity smoking risk consumption of alcohol unhealthy food habits stress overweight or abdominal obesity high lipids (cholesterol, LDL) high blood pressure diabetes/insulin resistance. Exclusion criteria: Not understand Swedish language

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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: structured lifestyle program<br>The program consisted of an individual visit to a nurse for a health check-up and lifestyle counseling at baseline, six month and one year. The program also consisted of five group educations which included lectures on nicotine, alcohol, physical inactivity, eating habits, stress, sleeping habits and behavior changes | Behavioral: Longterm effects after a structured lifestyle program<br>* present study was to describe a structured intervention to reduce cardiovascular risk in a clinical setting and to study the effects of the program on lifestyle habits and quality of life in individuals at risk after six months and one year.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular risk | change from baseline in waist circumference after one year | change from baseline in waist circumference after one year |
Use of EMG to Assess Clinical Hypertonia

Study Overview
=================
Brief Summary
-----------------
A handheld surface electromyography device will be tested by clinicians on children with limb hypertonia, and inter-rater reliability will be assessed with and without the device.

Detailed Description
-----------------
Hypothesis: Qualitative surface EMG measurement during passive movement will increase the inter-rater reliability of clinicians for diagnosis of spasticity and dystonia in children with hypertonia. Specific Aims: Develop a handheld surface EMG device with auditory output that can be used similarly to a stethoscope to listen non-invasively to the activity of muscles. Provide clinicians at 5 different institutions with a device to test for 2 months in their own clinics. Bring all 5 clinicians to Stanford University for a single-day exercise in which each clinician will examine 10 children with hypertonia. Each clinician will rate the children without using the device, and then again with the device. Intra-class correlations and kappa statistics will be used to assess whether the use of the device leads to improved inter-rater reliability.

Official Title
-----------------
Initial Assessment of the Use of Surface Electromyography as a Tool for Clinical Evaluation of Hypertonia in Children

Conditions
-----------------
Cerebral Palsy, Hypertonia, Spasticity, Dystonia, Rigidity

Intervention / Treatment
-----------------
* Device: portable surface electromyography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 6-18 hypertonia in at least one limb due to spasticity Exclusion Criteria: any condition that would increase the risk of participation

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: portable surface electromyography|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
-----------------
Hypertonia, Childhood
Pharmacogenomics of Paclitaxel in Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
This study will try to determine whether or not certain genes are responsible for the huge variation in toxicity and effect observed between patients treated with paclitaxel (chemotherapeutic drug). Specifically we will study this retrospectively in patients who participated in clinical trials that are now closed. All patients had ovarian cancer and received paclitaxel/carboplatin chemotherapy after primary surgery.

Detailed Description
-----------------
Paclitaxel is an antineoplastic drug used in the treatment of ovarian cancer. The effect and toxicity is unpredictable in the individual patient. Paclitaxel is removed (eliminated) from the organism by oxidation. CYP2C8 is the enzyme mainly responsible. P-glycoprotein (Pgp) is an efflux transport protein natural to the human organism. Pgp is responsible for excretion of drugs via the bile and the kidneys and is thought to play a role in chemotherapy resistance. Paclitaxel is substrate for Pgp. Single nucleotide polymorphisms are possible causes for variation in both CYP2C8 and Pgp expression/function. We will study a possible role of these genetic variations as predictors of paclitaxel toxicity and effect and the possible implications for individual dosing in the future. We will use tissue from patients who participated in one of two clinical trials that are both closed for inclusion. Genotypic data from this tissue will be correlated with toxicity and survival data drawn from a research database. We expect to be able to find >300 available cases to study.

Official Title
-----------------
Pharmacogenomics of Paclitaxel in Ovarian Cancer: Predictors of Toxicity and Response

Conditions
-----------------
Ovarian Neoplasms, Fallopian Tube Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients enrolled in TC/TEC in Denmark, Sweden or Norway Patients enrolled in OVAR-9 in Denmark, Sweden or Norway

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

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CYP2C8, MDR1, Pharmacogenetics, Paclitaxel
Comparison of a Short Uncemented Femoral Stem to a Similar Standard Uncemented Femoral Stem

Study Overview
=================
Brief Summary
-----------------
This randomized controlled trial will compare patients receiving a standard uncemented femoral stem with patients receiving an identically designed short uncemented femoral stem.

Detailed Description
-----------------
This randomized controlled trial will compare patients receiving a standard uncemented femoral stem with patients receiving an identically designed short uncemented femoral stem. Patients will be randomized a few days before the operation. At the time of surgery, the surgeon will use the relevant implant. Patients will be followed up for 5 years after surgery. The main outcome criteria is the stem subsidence measured radiographically with a dedicated software.

Official Title
-----------------
Randomized Controlled Trial Comparing a Short Uncemented Femoral Stem to a Similar Standard Uncemented Femoral Stem

Conditions
-----------------
Osteoarthritis, Hip

Intervention / Treatment
-----------------
* Device: total hip replacement - standard femoral stem
* Device: total hip replacement - short femoral stem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hip osteoarthritis requiring a total hip replacement >18 years old agrees to participate Exclusion Criteria: total hip replacement not indicated general anesthesia contraindicated previous surgery on the ipsilateral femur follow-up not possible

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: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized 1/1 comparison
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: hype standard<br>total hip replacement with standard femoral stem | Device: total hip replacement - standard femoral stem<br>* total hip replacement with standard femoral stem<br>|
| Experimental: hype mini<br>total hip replacement with short uncemented femoral stem | Device: total hip replacement - short femoral stem<br>* total hip replacement with short femoral stem<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stem subsidence | stem subsidence will be measured using the EBRA (Ein-Bild-Rontgen-analyse) software on postoperative antero-posterior radiographs (5 xrays from day one to year 2) | 2 years postop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative surgeon satisfaction | measurement of surgeon's satisfaction with using the instrumentation to insert the stem; on a Likert scale intraoperative complication | intraoperative |
Older Emergency Department Users and Hospitalization After an Index Visit: Results of ER2 Database

Study Overview
=================
Brief Summary
-----------------
This study evaluates the recommendations of a screening tool called: ER2 (Emergency Room Evaluation and Recommendations Form).This stool is used in Emergency Department by nurses, and it supposes to measure patient risk score.

Detailed Description
-----------------
Crowding and delay became chronic conditions in emergency departments (EDs) in high income countries. Emergency medicine has the mandate to provide care to any patient requesting treatment 24 hours a day. As there is a lack of primary care physicians who are able to provide the necessary care to patients, they are forced to seek care in ED. Among these ED users, more and more patients are aged over 65 and account for up to a quarter of all ED users. Older ED users comparted to their younger counterparts are more at risk for long length of stay in ED and hospital, and hospital admission during an index ED visit. The occurrence of these short-terms adverse events may be reduced if older ED users risk is assessed upon their ED arrival. Few studies have examined risk for short-terms adverse events. They suggested that clinical tools based on a brief geriatric assessment with timely appropriate interventions could reduce the occurrence of short-terms ED adverse events.

Official Title
-----------------
Older Emergency Department Users and Hospitalization After an Index Visit: Results of ER2 Database

Conditions
-----------------
Chronic Conditions, Multiple, Medical Emergencies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being 75 years and over Brought at Emergency on medical stretcher Exclusion Criteria: Being less than 75 years old Never come at Emergency

Ages Eligible for Study
-----------------
Minimum Age: 75 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 |
| --- | --- |
| Observational<br>The participants of this study will be seen at Emergency Department, and a nurse will perform a test called ER2 ( Emergency Room Evaluation and Recommendation). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long length of hospital stay | Long length of hospital stay represents an indicator of efficiency, and it refers to the average number of day that a patient spends in hospital. | Around 10 months |
3D Printed Bolus in Post-mastectomy Radiotherapy

Study Overview
=================
Brief Summary
-----------------
Recently, there is growing interest in the application of three-dimensional (3D) printed bolus to radiotherapy.At present, the researches on the application of 3D-printed bolus in breast cancer are mainly focused on air gap between skin and bolus or electron beam conformal therapy [7,15], there are no clinical experience with customized 3D-printed bolus for volumetric modulated arc therapy (VMAT) in daily practice has been published up to now. We aim to evaluate dosimetry and application of 3D-printed bolus for the post-mastectomy radiotherapy (PMRT) with Volumetric modulated arc therapy (VMAT). Seventy five patients with breast cancer receiving radiotherapy following post-mastectomy in our department were randomly selected in this study. The accuracy of fit of the 3D-Printed bolus to the chest wall was improved significantly relative to conventional bolus.This study demonstrates customized 3D-printed bolus in post-mastectomy radiation therapy improves fit of the bolus compared to conventional bolus. Furthermore, VMAT based on 3D-printed bolus significantly improves the chest wall target coverage and the conformity of plan, and reduces the dose of ipsilateral lung and heart, compared to conventional bolus.

Official Title
-----------------
Clinical Study of 3D Printed Bolus for Volumetric Modulated Arc Therapy of Post-mastectomy Treatment

Conditions
-----------------
Breast Neoplasms, Radiotherapy Side Effect

Intervention / Treatment
-----------------
* Other: customized 3D-printed bolus fabricated based on reconstruction of computed tomography (CT) images


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: breast cancer patients with post-mastectomy treatment Exclusion Criteria: NA
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D-printed bolus<br> | Other: customized 3D-printed bolus fabricated based on reconstruction of computed tomography (CT) images<br>* customized 3D-printed bolus fabricated based on reconstruction of computed tomography (CT) images were used in this study.<br>|
| No Intervention: Conventional bolus<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dose comparison | The prescription dose was 50 Gy in 25 fractions. Dose-volume histograms (DVHs) were used dosimetric analysis. D98%, D50% and D2%, indicating dose to 98% (near-minimum dose), 50% and 2% (near-maximum dose) of both target volumes, and V95%, V100%, and V110% indicating percent volume receiving 95%, 100% and 110% of prescribed dose, were recorded | one year |
Pilot Study to Validate ex Vivo Expression of Specific Biomarkers of Human Resolutive Macrophages

Study Overview
=================
Brief Summary
-----------------
Human resolutive macrophages are essential immune cells in the resolution of inflammation. This particular type of macrophages remains poorly known and currently there are no biomarkers to identify them in vivo. Within UMR1098-RIGHT, specific biomarkers (secreted molecules and membrane receptors) of human resolutive macrophages (healthy volunteers) have been identified in vitro, but their existence in vivo remains an outstanding issue. An exploratory study (lack of data from the literature) will validate the ex vivo expression of these markers in samples of patients whose inflammation is not, or little, supported by the available therapies (NSAIDs, biotherapies, corticosteroids).

Official Title
-----------------
Pilot Study to Validate ex Vivo Expression of Specific Biomarkers of Human Resolutive Macrophages

Conditions
-----------------
Inflammation

Intervention / Treatment
-----------------
* Procedure: blood sample or joint fluid or gingival exudate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age Limits (18-80 years) Information and non-opposition for participating in the study Patients suffering from periodontitis grade III ou IV Patients suffering from microcristalline arthritis patient with health insurance Exclusion Criteria: patient under corticotherapy pregnancy non-compliant patient patient with no health insurance patient in exclusion period from an other study legal incapacity

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

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

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

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 |
| --- | --- |
| Experimental: biologic sample collection<br>Blood samples or gingival exsudat collection | Procedure: blood sample or joint fluid or gingival exudate<br>* blood sample collected by peripheral blood mobilization joint fluid collected by punction gingival exudate collected with paper strips<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of cytokine concentrations in samples by ELISA |  | up to 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
macrophage, inflammation, inflammation resolution