linjc16/ctgov huggingface dataset:
Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
Prospective, randomized, controlled, parallel group clinical study with blinded assessment evaluating Sebacia Microparticles (SM) with Nd:Yag laser in facial inflammatory acne vulgaris

Official Title
-----------------
A Prospective, Multicenter, Randomized, Controlled, Evaluator-Blinded Study of the Safety and Effectiveness of Sebacia Microparticles as an Accessory to 1064 nm Nd:Yag Laser in the Treatment of Facial Inflammatory Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Device: Sebacia Microparticles
* Device: Nd:Yag Laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild to moderate acne vulgaris At least 15 inflammatory acne lesions Skin phototype I - III Able to understand and comply with study requirements Exclusion Criteria: Severe acne vulgaris Nodulocystic acne Ongoing use of medications and/or treatments for acne New hormone regimen (used for less than 12 weeks) Significant medical or mental health condition

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 45 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sebacia Microparticles<br> | Device: Sebacia Microparticles<br>* Topical microparticle suspension<br>|
| Active Comparator: Nd:Yag Laser<br> | Device: Nd:Yag Laser<br>* Laser delivering 1064 nm wavelength light<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of inflammatory acne lesions |  | Week 12 |
Maternal and Neonatal Outcomes After Membrane Sweeping

Study Overview
=================
Brief Summary
-----------------
This study aim to estimate maternal and neonatal outcomes after membrane sweeping in different group of patients.

Detailed Description
-----------------
Sweeping of the membranes is a simple technique usually performed during vaginal examination, in order to initiate labour by increasing local production of prostaglandins.

Official Title
-----------------
Maternal and Neonatal Outcomes After Membrane Sweeping

Conditions
-----------------
Sepsis, Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with a singleton pregnancy and confirmed cephalic presentation at or after 37 weeks of gestation who are candidate for vaginal delivery were eligible for the study Exclusion Criteria: Women with a multiple pregnancy, nonreassuring cardiotocogram, meconium stained amniotic fluid, major fetal anomalies, HELLP (hemolysis, elevated liver enzymes, and low platelets) syndrome, or severe preeclampsia and signs of intrauterine infections were not eligible. women who are not candidates for vaginal delivery: placenta previa, breech presentation, planned repeat cesarean.

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |
| Neonatal sepsis |  | Neonates will be followed for the duration of hospital stay, an expected average of 2-3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal infection | Neonates with two or more of the following signs: Altered behaviour or responsiveness, Altered muscle tone (floppiness), Feeding difficulties, Feed intolerance (vomiting, excessive gastric aspirates, abdominal distension), Abnormal heart rate (bradycardia or tachycardia), Signs of respiratory distress, Hypoxia (central cyanosis or reduced oxygen saturation level), Jaundice, Apnoea, Signs of neonatal encephalopathy, Seizures, Need for cardio-pulmonary resuscitation, Low-temperature (lower than 36°C), High-temperature (higher than 38°C), Signs of shock, Unexplained excessive bleeding, thrombocytopenia or abnormal coagulation, Oliguria, Altered glucose homeostasis (hypoglycaemia or hyperglycaemia), Metabolic acidosis, Local signs of infection. | Neonates will be followed for the duration of hospital stay, an expected average of 2-3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Membrane sweeping, Membrane stripping, Maternal outcomes, Neonatal outcomes
A Comparative Study of KSO-0400 in BPH Patients With LUTS

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the efficacy and safety of KSO-0400 compared to placebo for the treatment of LUTS caused by BPH.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Multicentre Study of KSO-0400 in BPH Patients With LUTS

Conditions
-----------------
Benign Prostatic Hyperplasia (BPH)

Intervention / Treatment
-----------------
* Drug: KSO-0400
* Drug: KSO-0400
* Drug: Silodosin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BPH patients with LUTS Exclusion Criteria: Patients with a history of prostatectomy, intrapelvic radiation therapy, thermotherapy of prostate or prostatic hyperthermia Patients with prostate cancer or suspected prostate cancer Patients who have any clinically relevant cardiovascular, hepatic or renal disorder

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

Sexes Eligible for Study
-----------------
Male

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KSO-0400 Low Dose<br> | Drug: KSO-0400<br> <br> |
| Experimental: KSO-0400 High Dose<br> | Drug: KSO-0400<br> <br> |
| Experimental: Silodosin<br> | Drug: Silodosin<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in I-PSS Total Score from baseline |  | Baseline and 12 weeks (LOCF) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in I-PSS Sub-score from baseline |  | Baseline and 12 weeks (LOCF) | 
| Change in QOL Score from baseline |  | Baseline and 12 weeks (LOCF) | 
| Change in Qmax (maximum urinary flow rate) from baseline |  | Baseline and 12 weeks (LOCF) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Benign Prostatic Hyperplasia, I-PSS, α1A-AR antagonist
The Role of Leptin Receptors in NASH

Study Overview
=================
Brief Summary
-----------------
NAFLD is a spectrum of liver diseases associated with varying degrees of hepatic steatosis, inflammation, and in some cases, fibrosis. NAFLD is a common observation in all demographics, but the prevalence of NAFLD and nonalcoholic steatohepatitis (NASH) is especially high in the morbidly obese population. Leptin is a cytokine that is encoded by the ob gene and primarily secreted by adipose tissue. The production of serum leptin increases with progressive obesity. Because of this observation, there has been significant interest in potential role of leptin in NAFLD. Our hypothesis is that we will find increased hepatic leptin and leptin receptor expression as the degree of hepatic injury worsens in NAFLD.

Official Title
-----------------
Leptin, Soluble Leptin Receptor and Adiponectin in Non Alcoholic Steatohepatitis

Conditions
-----------------
Nonalcoholic Steatohepatitis, Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: no interventions, only regular blood-draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing elective bariatric surgery, ages 18-65. Exclusion Criteria: non-obese patients, ages less than 18 and over 65. Pregnant patients.

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 |
| --- | --- |
| A<br>bariatric surgery | Other: no interventions, only regular blood-draw<br>* No interventions, only regular blood-draw (liver biopsy obtained per routine during the surgery)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To link SLR to grade/stage of NASH |  | 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To link SLR, leptin and adiponectin to features/components of the metabolic syndrome |  | 2.5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
leptin, leptin receptors, adiponectin
VTX-2337 in Combination With Radiotherapy in Patients Low-Grade B-cell Lymphomas

Study Overview
=================
Brief Summary
-----------------
This study is to determine the safety and effectiveness of VTX-2337 (an investigational drug that stimulates the immune system) in combination with radiation therapy in treating patients with low-grade B-cell lymphoma. Patients will receive 2 low doses of radiotherapy, and 9 intratumoral injections of VTX-2337 over the course of 3 months.

Official Title
-----------------
A Phase I/II Study of Intratumoral Injection of the Small Molecule TLR8 Agonist VTX-2337 in Combination With Local Radiation in Low-Grade B-cell Lymphomas

Conditions
-----------------
Low Grade B Cell Lymphoma

Intervention / Treatment
-----------------
* Drug: VTX-2337 plus radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Major Inclusion Criteria: low grade B cell lymphoma 1 or more sites of disease appropriate for intratumoral injection measurable disease other than the injection site Performance Status of 1 or better Adequate bone marrow, renal and hepatic function No active autoimmune disease or systemic immunosuppressive drugs Life expectancy > 4 months Exclusion Criteria: Known HIV Known brain metastases Malignancy within last 5 yrs (basal cell or non-invasive squamous cell carcinoma OK) Anticoagulation therapy other than 325mg QD ASA Significant cardiovascular disease Pregnant or nursing

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 |
| --- | --- |
| Other: VTX-2337 plus radiation<br> | Drug: VTX-2337 plus radiotherapy<br>* Radiation on Day 1. On Day 2, VTX-2337 3.0mg/m2 is administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then given weekly for 3 weeks in a 4 week cycle over 3 cycles.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Whose Tumors Responded to Treatment With Intratumoral Injection of VTX-2337 in Combination With Low-Dose Local Radiation. | Tumor response was assessed via CT scans of the chest, abdomen, pelvis or other medically appropriate imaging modality to evaluate all areas of disease. Cheson Criteria were used for calculation of response. | Tumor assessment conducted at 12 weeks and every 3-6 months thereafter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the Safety and Feasibility of the Combination Regimen. |  | Safety assessed throughout study period. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
B cell, lymphoma
Haplo-identical/Mismatched Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome

Study Overview
=================
Brief Summary
-----------------
Allogeneic hematopoietic stem cell transplantation (HSCT) is currently the only curative treatment for myelodysplastic syndrome (MDS), especially for advanced MDS (blast >5%). However, many patients cannot find an HLA-matched donor. haploidentical donor is an alternative stem cell source. the study hypothesis: Haploidentical/mismatched hematopoietic stem cell transplantation can improve the survival of patients with myelodysplastic syndrome

Official Title
-----------------
Haplo-identical/Mismatched Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome

Conditions
-----------------
Advanced MDS Without Identical Sibling Donor

Intervention / Treatment
-----------------
* Procedure: transplant with haploidentical donor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with MDS (1)intermediate-2 or high risk (2)low or intermediate-1 risk with drug resistance or disease progression without identical sibling donor Exclusion Criteria: Contraindication to HSCT Pregnancy Mental illness

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 60 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 |
| --- | --- |
| haploidentical transplant<br>transplant with haploidentical donor | Procedure: transplant with haploidentical donor<br>* patients with advanced MDS without identical sibling donor receive haploidentical transplant<br>* Other names: haploidentical transplant;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival rate | number of participants with survival at one year | participants will be followed for an expected average of one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of non-relapse mortality | number of participants with non-relapse mortality at one year | one year |
Impact of Acthar on Everyday Life of Participants With Severe Keratitis

Study Overview
=================
Brief Summary
-----------------
We will need about 36 participants for this study. Volunteers might be able to participate if: they have bad noninfectious keratitis early treatments failed or were not well tolerated Participants will be in the study for about 22 weeks: 4 weeks for tests to see if the study might be good for them 12 weeks of treatment with Acthar gel 4 weeks to wean off Acthar gel and follow-up with the doctor

Official Title
-----------------
A Multicenter, Open-label Study to Assess the Efficacy and Safety of Acthar® Gel in Subjects With Severe Keratitis

Conditions
-----------------
Keratitis

Intervention / Treatment
-----------------
* Drug: Acthar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has severe or recalcitrant keratitis Did not respond to, or tolerate, treatment with topical cyclosporine, Lifitegrast, or any immunosuppressant to treat keratitis If able to reproduce, agrees to use 2 forms of effective contraception with a partner of the opposite sex for the duration of the study (through Visit 6) Has normal eyelids, and protocol-defined physical and medical eye attributes Agrees to avoid wearing contact lenses during the trial Exclusion Criteria: Is pregnant or breast-feeding Is defined as vulnerable, or is employed by, or related to anyone involved in the study Has a medical condition or history that might, per protocol or in the opinion of the investigator, compromise the participant's safety or study analysis

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: All participants<br>Participants receive: a shot of Acthar (80 units) under the skin twice a week for 12 weeks a shot of Acthar (40 units) twice a week for 2 weeks a shot of Acthar (40 units) once a week for 2 more weeks At each visit they will have medical tests and answer questions about their symptoms. | Drug: Acthar<br>* Acthar gel for subcutaneous injection<br>* Other names: Acthar Gel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Improved on the Impact of Dry Eye on Everyday Life (IDEEL) Scale [Using the Symptom Bother Module at Week 12] | A 12-point score reduction on the 100-point symptom bother module indicates a clinically important reduction of bothersome dry eye symptoms. | Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Severe or recalcitrant keratitis
A Study of TCD601 in the Induction of Tolerance in de Novo Renal Transplantation (PANORAMA)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the optimal regimen for the use of siplizumab, a human anti-CD2 antibody, combined with donor bone marrow cells and non-myeloablative conditioning, for tolerance induction in de novo living donor renal transplantation.

Official Title
-----------------
An Adaptive, Regimen Finding, Safety and Tolerability Study of TCD601 (Siplizumab), a Human Anti-CD2 Antibody, Combined With Donor Bone Marrow Cell Infusion and Non-myeloablative Conditioning, for Tolerance Induction in de Novo Living Donor Renal Transplantation

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Biological: TCD601


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Able to understand the study requirements and provide written informed consent before and study assessment is performed Male or female patients ≥ 18 to 60 years of age Recipient of a first or second renal transplant from a non-HLA identical, but at least haploidentical, ABO compatible living donor Key Exclusion Criteria: Women of child-bearing potential Subjects with a history of cancer Donor-specific Antibody

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>TCD601administered with non-myeloablative conditioning and standard of care immunosuppression | Biological: TCD601<br>* Investigational Product<br>|
| Experimental: Arm 2<br>TCD601administered with non-myeloablative conditioning and standard of care immunosuppression | Biological: TCD601<br>* Investigational Product<br>|
| Experimental: Arm 3<br>TCD601administered with non-myeloablative conditioning and standard of care immunosuppression | Biological: TCD601<br>* Investigational Product<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The optimal regimen for renal allograft tolerance while minimizing chimeric transition syndrome | The proportion of patients off immunosuppression with good safety and tolerability | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of biopsy proven acute rejection, death and graft loss |  | 24 months | 
| The incidence of de novo donor-specific antibody |  | 24 months |
Atezolizumab Plus Bevacizumab and Chemotherapy in First-Line Metastatic Nonsquamous NSCLC

Study Overview
=================
Brief Summary
-----------------
This study aimed to explore the efficacy of Atezolizumab Plus Bevacizumab and Chemotherapy in First-Line Metastatic Non-squamous NSCLC.

Detailed Description
-----------------
This study aimed to explore the efficacy of Atezolizumab Plus Bevacizumab and Chemotherapy in First-Line Metastatic Non-squamous NSCLC.

Official Title
-----------------
Atezolizumab Plus Bevacizumab and Chemotherapy in First-Line Metastatic Nonsquamous NSCLC

Conditions
-----------------
Non-squamous NSCLC

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18，Advanced Metastatic Non-squamous NSCLC Treatment Plan is atezolizumab-bevacizumab-carboplatin-paclitaxel Exclusion Criteria: Patients with contraindication of chemotherapy Pregnant or breast feeding women

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 |
| --- | --- | --- |
| OS | overall survival | September 2019- september 2021 | 
| PFS | progression-free survival | September 2019- september 2021 |
Influence of Spinal Manipulative Therapy Upon Stroop Task Performance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if spinal manipulative therapy can affect cognitive processing as determined by performance on a Stroop task. It is specifically hypothesized that number of errors and response times will decrease as a result of spinal manipulative therapy.

Conditions
-----------------
Motor Response Time

Intervention / Treatment
-----------------
* Procedure: Spinal manipulative therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal healthy Exclusion Criteria: No spinal manipulation one week proceeding trial No stimulants or depressants

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Spinal manipulative therapy|nan|

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

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