linjc16/ctgov huggingface dataset:
Safety, Tolerability and Pharmacodynamics of CYT013-IL1bQb in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to test safety and tolerability of a vaccine targeting Interleukin-1 beta in patients with type 2 diabetes.

Official Title
-----------------
A Two-Stage Randomized Placebo-controlled Ascending Dose Phase I/ IIa Study to Evaluate Safety, Tolerability, Pharmacodynamic Effects and Preliminary Efficacy of an Anti-Interleukin 1 Beta Vaccine (CYT013-IL1bQb) in Patients With Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: CYT013-IL1bQb
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of type 2 diabetes mellitus, according to the American Diabetes Association diagnostic criteria, ≥ 3 months at time of randomization HbA1c in the range of 6.5 - 9.5% (inclusive) at screening Treatment with diet and exercise alone or a stable dose of metformin, or sulfonylurea, or metformin plus a sulfonylurea for at least 4 weeks prior to randomization Further criteria as defined in the clinical trial protocol Exclusion Criteria: Symptoms of hyperglycemia (i.e. polyuria and polydypsia) History of significant weight gain or loss (+/-5%) during the 4 weeks before randomization Fasting C-peptide level < 400 pmol/L at screening Change in the medicamentous treatment of elevated blood pressure, diabetes mellitus or dyslipidemia within 4 weeks prior to the randomization Use of any weight loss medication (over the counter prescription) or initiation of a prescribed weight management or exercise program within 4 weeks before randomization Current systemic anti-inflammatory therapy other than aspirin ≤ 100 mg/day or immunosuppressive treatment, in particular oral corticosteroids

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: CYT013-IL1bQb<br>* s.c. injection<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* s.c. injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | continously | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological measures of glycemia and inflammation |  | continously |
Pregnancy Outcomes in Infertile Patients After Treatment With Ulipristal Acetate.

Study Overview
=================
Brief Summary
-----------------
The investigators analyzed a group of infertile women treated with Ulipristal Acetate (UA) for uterine fibroids at the Humanitas Fertility Center. All the patients' data were extracted from the Fertility Center external-audit-anonymized electronic research query system.

Detailed Description
-----------------
In the recent years several large studies have been published on the efficacy of Ulipristal Acetate treatment of moderate to severe symptoms of uterine fibroids in adult women: initially proposed only as pre-surgical treatment, the UA was subsequently also used for the long-term treatment of uterine myomas symptoms. However, few data are available on the effects of UA in terms of increasing fecundability, implantation and pregnancy outcome and safety in the general population, and in infertile patients in particular. This retrospective study aims at describing the correlation between the use of Ulipristal Acetate and pregnancy outcome in infertile patients and at comparing the UA plus surgery approach to the UA-only treatment in terms of pregnancy outcome.

Official Title
-----------------
Pregnancy Outcomes in Infertile Patients After Treatment With Ulipristal Acetate: Preliminary Academic Assisted Reproductive Technology Center Experience.

Conditions
-----------------
Myoma;Uterus, Infertility, Female

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infertile women received at least 1 month of therapy with UA 5 mg/day for uterine fibroids more of 1 year of active pregnancy seeking Exclusion: menopausal women;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| treated<br>The women included were patients of the Humanitas Fertility Center; they all had a diagnosis of infertility and were trying to become pregnant. They received ≥1 month of therapy with UA 5 mg/day | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation rate | number of intrauterine gestational sacs observed divided by the number of transferred embryos | 2013 - 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| myomas reduction | volumetric reduction in after therapy | 2013 - 2018 |
Medical Review: Hand Surgery After Local Block Versus Non-block

Study Overview
=================
Brief Summary
-----------------
In this study, the effects of local block vs non block will be assessed with respect to postoperative outcomes (such as pain score, and recovery profiles) in outpatients after hand surgery.

Detailed Description
-----------------
Analyzing medical records and through a telephone questionnaire, in a retrospective and prospective review respectively.

Official Title
-----------------
Retrospective Chart-review Study Involving Outpatients Who Underwent Hand Surgery With Local Anesthesia: Comparing Outcome With a Peripheral Nerve Block vs. Local Infiltration Alone

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-80 years old Outpatients who underwent hand surgery under peripheral nerve block or local infiltration alone Exclusion Criteria: Patients who do not meet inclusion criteria

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Under Local Infiltration<br> | |
| Under Peripheral Nerve Block<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | Severity of the pain experienced before patient left the surgery center and after patient arrived at home Pain medication (amounts of opioids and non opioids pills) required d)Time to suffer pain at the surgical site (hand) (days, weeks, or months) | hours to months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea | Severity of the nausea experienced by the patient. Medication required. Time to suffer nausea. | days to weeks | 
| Vomiting | Severity Medication required Time to suffer vomiting | dias to weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain management, ambulatory surgery, opioid, local anesthesia, hand surgery, postoperative pain
Comparison of Bone Mineral Loss in Prostate Cancer Patients Who is Receiving GnRH Agonist and -Plus Anti-androgen Agent

Study Overview
=================
Brief Summary
-----------------
Comparison of bone mineral loss in prostate cancer patients who is receiving GnRH agonist and -plus anti-androgen agent

Detailed Description
-----------------
MC MD

Official Title
-----------------
Comparison of Bone Mineral Loss in Prostate Cancer Patients Who is Receiving GnRH Agonist and -Plus Anti-androgen Agent

Conditions
-----------------
GnRH Agonist Alone vs. GnRH Agonist Plus Anti-androgen Combination Treated Prostate Cancer Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Korean prostate cancer over 50 years old with pathological confirmation Patients receiving GnRH antagonist or GnRH agonist plus anti- androgen combination within 6 months since starting. Patients measured bone density level before starting to receive hormone therapies above. Exclusion Criteria: Patients who are treated other anti-osteoporosis drugs and who are treated bisphosphate due to BMD T score below -3.0. Patients who are hard to be analysed by attach to other bone disease. Patients who are hard to be analysed by limitation of chart record according to investigators'discretion.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Total of 250 prostate cancer patients receiving GnRH agonist | |
| B<br>Total of 250 prostate cancer patients receiving GnRH agonist plus anti-androgen agent | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of bone density before and after hormone therapy |  | 1 year | 
| comparison of bone density between GnRH agonist alone vs. CAB group |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between osteoporosis risk factors such as age, weight, history of smoke, history of alcohol and bone density value |  | 1 year | 
| correlation between osteoporosis risk factors such as age, weight, history of smoke, history of alcohol and bone density value before and after hormone therapy |  | 1 year | 
| 1year comparison of FRAX score before and after hormonal therapy |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone mineral loss, prostate cancer, GnRH agonist alone vs. GnRH agonist plus anti-androgen combination
Fluid Management for Cesarean Section

Study Overview
=================
Brief Summary
-----------------
Cesarean section-associated hypotension is one of the pivotal factors to influence the Apgar Score of children and related with the stable hemostasis during the whole process of labor. How to keep circulation in a consistent stability is yet to be known. The investigators hypothesized that different fluids, crystalloids or colloids, can produced varying effects in keeping the physiological environment of labor from significant fluctuating.

Official Title
-----------------
Fluid Management With Ringer's and 6% Starch for Cesarean Section After Epidural or Spinal Anesthesia

Conditions
-----------------
Cesarean Section

Intervention / Treatment
-----------------
* Other: Ringer's Lactate
* Other: 6% Starch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 21-40 yr First time of delivery ASA status I-II No premature No genetic and infectious diseases Chinese Exclusion Criteria: < 21 yr > 40 yr Subjects with cardiac and pulmonary disorders Dislocation of placenta Pregnant hypertension Allergy to local anesthetics Unwilling to cooperation Need intraoperative administration of vascular active agents With significant delivery side effects

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Participants were treated with normal Ringer's solution 15 min before the operation. | Other: Ringer's Lactate<br>* Ringer's Lactate was used 15min before operation<br>* Other names: RL;|
| Active Comparator: 2<br>6% Starch was used 15min before operation followed epidural anesthesia. | Other: 6% Starch<br>* 6% Starch was used 15min before operation<br>* Other names: ST;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total volume of colloid Total volume of crystalloid Total fluid volume |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage reduction in hematocrit, Days in hospital |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Regional anesthesia, Fluid Therapy, Hemostasis, Surgical
Large Abdominal Hernia Repair With SurgiMend 3.0

Study Overview
=================
Brief Summary
-----------------
The rate of hernia recurrence at one year following repair of a large abdominal hernia with a biologic mesh is high, ranging from 30% to 100%, with a reported historic average rate of 40%. The purpose of this study is to evaluate the rate of hernia recurrence at one year following repair with SurgiMend 3.0, an FDA-cleared novel biologic mesh, the hypothesis being that such rate will be less than 20% at one year, representing a 50% reduction over the historic rate of 40%.

Official Title
-----------------
Repair of Large Abdominal Hernia Defects By A Novel Biologic Mesh: A Prospective Multi-Center Observational Study

Conditions
-----------------
Hernia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All three of the following criteria must be present for enrollment into the study: Large abdominal hernia Inability to close the fascia primarily Contra-indication for the use of synthetic mesh Age > 18 years Exclusion Criteria: Use of SurgiMend 3.0 to simply reinforce a complete closure of the fascia performed either primarily or sequentially or by component separation technique Inability to close the skin over the SurgiMend 3.0

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia recurrence |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Repair of a large hernia with SurgiMend 3.0, a biologic mesh
Study to Evaluate Safety, Tolerability and Immunogenicity of Vaccine (UB 311) in Subjects With Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this Phase I study is to determine whether the vaccine (UB 311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and immunogenic in patients diagnosed with mild or moderate Alzheimer's disease (AD). Amyloid beta was selected as the target antigen based on supporting evidence of the hypothesis that places the accumulation of amyloid beta at the initiating step of AD.

Official Title
-----------------
A Phase I, Open-Label Study to Evaluate the Safety, Tolerability and Immunogenicity of the UBITh AD Immunotherapeutic Vaccine (UB 311) in Patients With Mild to Moderate Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Biological: UB 311


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of mild to moderate Alzheimer's Disease Mini-Mental State Examination (MMSE) 15-25 Other inclusion criteria apply Exclusion Criteria: Major psychiatric disorder Severe systemic disease Serious adverse reactions to any vaccine Other exclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccine (UB 311)<br> | Biological: UB 311<br>* Single liquid dose by intramuscular route at weeks 0, 4, 12.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate safety and tolerability of the vaccine (UB 311). |  | Screen, treatment & follow-up: 28-30 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate immunogenicity [and efficacy] of the vaccine (UB 311). |  | Screen, treatment & follow-up: 28-30 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's disease, amyloid beta, vaccine
Effect of Early Enteral Nutrition on Serum Acetylcholine Level and Inflammation in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
Early enteral nutrition(EEN) is an important treatment for critical ill patients and attenuate systemic inflammation, but the mechanisms are not clear. Thus the investigator conducted this study to observe if EEN affects systemic inflammation though regulation of blood acetylcholine

Official Title
-----------------
Effect of Early Enteral Nutrition on Serum Acetylcholine Level and Inflammation in Critically Ill Patients

Conditions
-----------------
Critical Illness, Enteral Nutrition, Inflammation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: initiating enteral nutrition within the first 24-48h after intensive care unit (ICU) admission age more than 18 years Acute Physiology and Chronic Health Evaluation II (APACHE II) score >8 Exclusion Criteria: not expected to survive 24 hours pregnancy any terminal stage disease

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality | The number of survival and non-survival patients 28 days after inclusion | 14 months | 
| Intestinal barrier function within one week | The measurement of serum d-lactate was applied to evaluate the intestinal barrier function | 14 months |
Population Pharmacokinetics, Effectiveness and Safety of Cefuroxime in Neonates

Study Overview
=================
Brief Summary
-----------------
Cefuroxime is a time-dependent antibiotic that is used to treat bacterial infections. However, population pharmacokinetic，effectiveness and safety data for cefuroxime in neonates are lacking. The aim of this study was to assess the population pharmacokinetics, effectiveness, and safety of cefuroxime in neonates.

Official Title
-----------------
Population Pharmacokinetics, Effectiveness and Safety of Cefuroxime in Neonates

Conditions
-----------------
Infectious Disease

Intervention / Treatment
-----------------
* Drug: Cefuroxime


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: postnatal age ≤28 days; Cefuroxime used as part of antimicrobial treatment; Parental written consent. Exclusion Criteria: Expected survival time less than the treatment cycle; Receiving other systemic trial drug therapy; Other factors that the researcher considers unsuitable for inclusion.

Ages Eligible for Study
-----------------
Minimum Age: 0 Days
Maximum Age: 28 Days

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cefuroxime|Population pharmacokinetics, effectiveness, and safety of cefuroxime|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The peak plasma drug concentration of cefuroxime | To detect the peak plasma drug concentration of cefuroxime after intravenous administration. | at (5-10) minutes after intravenous administration | 
| The random plasma drug concentration of cefuroxime | To detect the random plasma drug concentration of cefuroxime after intravenous administration. | at (0.25-10) hours after intravenous administration. | 
| The trough plasma drug concentration of cefuroxime | To detect the trough plasma drug concentration of cefuroxime after intravenous administration. | at 1-2 hours before the next administration | 
| The time of free drug concentration exceeding the minimal inhibitory concentration (fT>MIC) | PD target | Through study completion, an average of 3 days | 
| Adverse events | Drug-related adverse events and serious adverse events | Through study completion, an average of 15 days |