linjc16/ctgov huggingface dataset:
Efficacy and Safety of Botulinum Toxin at Moderate to Severe Glabellar Lines

Study Overview
=================
Brief Summary
-----------------
Efficacy and safety of ATGC-100 are assessed in subjects with moderate to severe glabellar lines.

Official Title
-----------------
A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase 3 Clinical Trial to Compare the Efficacy and Safety of ATGC-100 Versus Botox in Subjects With Moderate to Severe Glabellar Lines

Conditions
-----------------
Glabellar Frown Lines

Intervention / Treatment
-----------------
* Biological: ATGC-100 100U
* Biological: Botox 100U


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female aged 19 to 65 years old Participants with Facial Wrinkle Scale (FWS) score of > 2 at maximum frown at screening Participants willing to follow the study procedures and schedules Participants willing to give written informed consent to participate in the trial Exclusion Criteria: Participants with severe glabellar lines that cannot be improved physical method Pregnant, lactating women or women of childbearing age not using a reliable method of contraception Participants with known hypersensitivity to any component of the study drug Participant who has skin disorder including infection and scar on injection site

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ATGC-100 100U<br>ATGC-100 will be injected to 5 glabellar lines (each 4U/0.1mL; total 20U) at Day 0 | Biological: ATGC-100 100U<br>* Clostridium botulinum toxin type A<br>|
| Active Comparator: Botox 100U<br>Botox inj. will be injected to 5 glabellar lines (each 4U/0.1mL; total 20U) at Day 0 | Biological: Botox 100U<br>* Clostridium botulinum toxin type A<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with improvement of glabellar lines at maximum frown | Improvement rate of glabellar lines at maximum frown with Physician's Facial wrinkle scale (FWS) | 4 weeks post injection compared to baseline |
An Observational Study of Patients With Malignant Lymphomas Treated With MabThera® SC in Everyday Clinical Practice

Study Overview
=================
Brief Summary
-----------------
This observational study aims to assess the therapeutic responsiveness of MabThera SC in patients with malignant lymphomas under everyday clinical practice conditions. Patients with previously untreated CD-20 positive follicular non-Hodgkin's lymphoma (NHL) or previously untreated CD-20 positive diffuse large B-cell lymphoma (DLBCL) who are planned for therapy with MabThera SC according to the assessment of the physician will be prospectively enrolled for observation. No study specific measures are required; treatment and documentation will be performed according to usual clinical practice.

Conditions
-----------------
Lymphoma, B-Cell, Lymphoma, Follicular

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women and men aged >=18 years Previously untreated CD-20 positive follicular NHL Previously untreated CD-20 positive DLBCL Planned therapy with MabThera SC according to the assessment of the physician (before the start and independent from this study) Suitability for the therapy with MabThera SC Exclusion Criteria: All contraindications, interactions and incompatibilities for therapy with MabThera SC

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 |
| --- | --- |
| Follicular NHL Cohort<br> | |
| DLBCL Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients in both indications (DLBCL and follicular NHL) who have reached a complete remission (CR), including unconfirmed complete remission (CRu) |  | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total response rate |  | Up to 2.5 years | 
| Two-year progression-free survival rate for patients with follicular lymphoma under maintenance therapy |  | 2 years | 
| Safety profile: incidence, nature, severity, and outcomes of all adverse events and pregnancies (composite outcome measure) |  | Up to 2.5 years |
Validity of Elastography During Pregnancy

Study Overview
=================
Brief Summary
-----------------
Non invasive methods are the only available methods to stage liver fibrosis during pregnancy. The safety of elastometry - ultrasound based - is obvious, as medical supervision of pregnancy is based on ultrasonography, both methods using same wavelengths. Therefore, this method is sometimes used in pregnant women with recent diagnosis of chronic viral hepatitis infection, whereas its validity in pregnant women has never been studied. This lack of data justifies our study.

Detailed Description
-----------------
One measurement during the third trimester of pregnancy will be compared to a second measurement, 3 months after childbirth.

Official Title
-----------------
Validity of Non-invasive Liver Fibrosis Assessment by Ultrasound-based Elastography at the Third Trimester of Pregnancy: a Prospective Study

Conditions
-----------------
Hepatitis B Virus Infection; Pregnant Women

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women Followed in Obstetrics Dpt HBV or HCV chronic hepatitis After information and written consent Exclusion Criteria: None

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 |
| --- | --- | --- |
| Difference between the fibrosis score during and after pregnancy |  | 3 to 6 months after delivery |
Feasibility Study of Modified Atkins Ketogenic Diet in the Treatment of Newly Diagnosed Malignant Glioma

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to see if people can produce ketones in their blood with the modified Atkins diet. Modified Atkins diet is a diet that produces ketones in your blood by restricting carbohydrates to <20 grams per day. Ketones are substances that are produced in the blood when fat is being broken down. Ketones may help radiation work better and may starve your tumor because it is thought that some brain tumors can not use ketones to grow and can only use sugar or glucose to grow.

Official Title
-----------------
Feasibility Study of Modified Atkins Ketogenic Diet in the Treatment of Newly Diagnosed Malignant Glioma

Conditions
-----------------
Glioblastoma

Intervention / Treatment
-----------------
* Other: Modified Atkins Ketogenic Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed primary malignant glioma, Grade III or IV No uncontrolled infection or other active malignancy or chronic systemic immune therapy. ECOG performance status < 3. Life expectancy > three months. Adequate labs Exclusion Criteria: Diagnosis of genetic disorder of fat metabolism. Type 2 diabetes diagnosed with a hemoglobin A1C > 6.4 Allergic to dairy or lactose intolerance

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Atkins Ketogenic Diet<br>Modified Atkins Ketogenic Diet in combination with Temodar and Radiation | Other: Modified Atkins Ketogenic Diet<br>* Less than 20 grams of carbohydrates per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of inducing ketosis | Ketosis measured by serum beta-hydroxybuterate | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of progression free survival |  | 6 months | 
| Assessment of survival |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brain tumor
Severe Cutaneous Adverse Reactions in Thailand

Study Overview
=================
Brief Summary
-----------------
The multicenter registry of patients with severe cutaneous adverse reactions among tertiary medical institutes in Thailand to study clinical characteristics, etiologies, therapeutic outcomes, quality of life, and the values of in vitro drug allergy diagnosis for the confirmation of the causative drugs

Detailed Description
-----------------
Patients with severe cutaneous adverse reactions (Steven-Johnson Syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis, and generalized bullous fixed drug eruption) among six tertiary medical institutes in Thailand will be recruited to study clinical characteristics, etiologies, therapeutic outcomes, quality of life, and the values of using laboratory techniques for the confirmation of the causative drugs

Official Title
-----------------
The Multicenter Registry of Patients With Severe Cutaneous Adverse Reactions Among Tertiary Medical Institutes in Thailand

Conditions
-----------------
Steven-Johnson Syndrome, Toxic Epidermal Necrolysis, Drug Reaction With Eosinophilia and Systemic Symptoms, Acute Generalized Exanthematous Pustulosis, Generalized Bullous Fixed Drug Eruption

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients fulfilled criteria of probable or definite cases of SJS, TEN, DRESS, or AGEP according to RegiSCAR validation criteria as well as patients diagnosed with GBFDE Exclusion Criteria: Patients later confirmed to have other diagnosis than diseases mentioned above or have no sufficient data for the registry

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| SCAR Patients<br>Patients diagnosed with severe cutaneous adverse reactions with be recruited | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 1 year | 
| Diagnostic values of in vitro tests for drug allergy diagnosis |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Percentages of patients suffer from severe cutaneous adverse reactions will be reported and categorized according to organ involvement | 1 year | 
| Quality of Life | Patient's quality of life will be assessed by using The World Health Organization Quality of Life (WHOQOL)-BREF; Thai version and The Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q); Thai version | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
drug allergy, drug hypersensitivity, adverse drug reactions, severe cutaneous adverse reactions
MSCs Therapy for Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
Cerebral palsy (CP) is the most common physical disability in childhood. CP comprises a heterogeneous group of disorders that are the result of a non-progressive disruption or injury that occurred during fetal brain development or within the first two years of life.

Detailed Description
-----------------
This disruption can result in spasticity, dystonia, muscle contractures, weakness and difficulty in coordination that ultimately affects the ability to control movements. Resultant activity limitations may affect gross motor movements, fine motor movements, speech and communication, as well as eating and drinking.

Official Title
-----------------
Bone Marrow Stem Cells Transplantation for the Treatment of Cerebral Palsy

Conditions
-----------------
Stem Cell Transplant Complications

Intervention / Treatment
-----------------
* Other: stem cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Must be more than 2 year of age and less than 12 years of age at the time of screening for inclusion in the study. Clinical evidence of a non-progressive motor disability due to brain dysfunction. Exclusion Criteria: • Intractable seizures Traumatic brain injury Genetic disorder Current Infection Renal insufficiency Hepatic disease HIV+ (as demonstrated by positive blood test) Immunosuppression

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 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: stem cells<br>Intravenous and Intrathecal transplantation of specific populations of purified bone marrow-derived stem cells and mesenchymal stem cells. | Other: stem cells<br>* Intravenous and Intrathecal transplantation of specific populations of purified bone marrow-derived stem cells and mesenchymal stem cells.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Motor Performance. | the number of patients who will have changes in motor performance | 6 months |
Impact of Staphylococcus Aureus on Folliculitis Decalvans

Study Overview
=================
Brief Summary
-----------------
The folliculitis decalvans (FD) is an orphan disease , common in consultation specialized on scalp. This disease is currently not curable, responsible for significant for patients. The pathophysiology is poorly understood, Staphylococcus aureus (SA) appears to play a role, never previously studied, and the study will attempt to clarify it. Controversies in the literature on the pathophysiological hypotheses can be summed up as follows : FD is it an infectious folliculitis where SA (almost always found on the lesions plays a direct role possibly aided by a lack of local immune protection , or is it a pustular inflammatory unknown cause where the SA has no direct role but is a cofactor or a simple germ superinfection. Our study has plans to bring new evidence to help decide between these two opposite but not mutually exclusive concepts .

Official Title
-----------------
Role of Staphylococcus Aureus on Folliculitis Decalvans. A Comparative Bacteriological Study.

Conditions
-----------------
Folliculitis Decalvans, Staphylococcus Aureus

Intervention / Treatment
-----------------
* Other: no intervention : case control study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (>18 yo) Alopecia folliculitis decalvans At least 6 months of evolution no antibiotics presence of pustules and crusts Adult (>18 yo) Exclusion Criteria: immunosuppression pregnancy

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 |
| --- | --- |
| case<br>Patient with a folliculitis Decalvans | Other: no intervention : case control study<br> <br> |
| control<br>Control without folliculitis decalvans | Other: no intervention : case control study<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of Staphylococcus Aureus in cutaneous biopsies (at least one colony) | The primary endpoint is the presence of Staphylococcus Aureus in cutaneous biopsies before any therapy and notably antibiotics. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of Staphylococcus Aureus in cutaneous biopsies (at least one colony) after treatment |  | 10 weeks | 
| presence of Staphylococcus Aureus in nasal swab (at least one colony) |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
folliculitis decalvans, Staphylococcus Aureus, antibiotics
Effect of Burn Size on Cytomegalovirus Reactivation and Correlates of T Cell Immune Function in Burned Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of burn injury on the human immune system with a focus on cytomegalovirus (CMV) reactivation and the immunologic correlates of latent viral reactivation. Subjects will be patients admitted to the North Carolina Jaycee Burn Center with burn injury. Blood samples will be collected over time and will be evaluated for CMV reactivation and immune cell phenotype.

Detailed Description
-----------------
The purpose of this research study is to learn about infections and the immune system in people who suffer from burn injuries. The immune system changes after burn injury and infection is one of the most common complications. Cytomegalovirus (CMV) is a virus that most people are exposed to early in life; once you are exposed it lays inactive in your body forever. When the immune system is suppressed, this virus can reactivate. We would like to measure how this virus makes copies of itself in the blood stream in people with a burn injury and to look at cell markers of the immune system. This study involves baseline and weekly blood draws for approximately 8 weeks. If blood tests show CMV infection, further monitoring of blood work may be needed after eight weeks.

Official Title
-----------------
A Prospective Longitudinal Study of the Effect of Burn Size on Cytomegalovirus Reactivation and Correlates of T Cell Immune Function in Patients Sustaining Significant Burn Injury

Conditions
-----------------
Burns, Cytomegalovirus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Burn injury, Positive CMV IgG level confirmative of previous CMV infection and latency. Exclusion Criteria: Immunocompromising conditions including HIV/AIDS, End-stage renal disease, End-stage liver disease, Pregnancy, Rheumatologic or collagen-vascular disease requiring chronic use of steroids, Chronic use of immunosuppressive agents, Recent chemotherapy, and History of solid organ or allogeneic stem cell transplant.

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 |
| --- | --- | --- |
| CMV IgG and viral load PCR |  | Weekly until viremia resolved (negative viral load by PCR) |
Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS

Study Overview
=================
Brief Summary
-----------------
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment with DSXS .

Detailed Description
-----------------
Evaluate the potential of DSXS topical product to suppress HPA axis function in patients with moderate to severe scalp psoriasis. Evaluate the efficacy parameters and adverse event (AE) profiles of DSXS topical product administered to patients with moderate to severe scalp psoriasis.

Official Title
-----------------
An Open-Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS in Patients With Moderate to Severe Scalp Psoriasis

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or non-pregnant, non-lactating females 18 years of age or older. IRE-approved, signed informed consent form that meets all criteria of current FDA regulations. Exclusion Criteria: Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy.

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?
-----------------

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 once daily for 28 days | Drug: DSXS Topical product<br>* once daily for 28 days<br>* Other names: Active;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients in the Study With HPA Axis Suppression | Hypothalamic Pituitary Adrenal (HPA) Axis Response to stimulation | 28 days |