linjc16/ctgov huggingface dataset:
Uses of Gamma Irradiated Amniotic Membrane as an Alternative Method in Psoriasis Treatment

Study Overview
=================
Brief Summary
-----------------
Using of human amniotic membrane extra-cellular matrix as a topical treatment for improving Psoriasis Area and Severity Index (PASI).

Detailed Description
-----------------
Human amniotic membrane extra-cellular matrix was purchased from National center for radiation research and technology, Egypt, under commercial name REGE pro gel.

Official Title
-----------------
Uses of Gamma Irradiated Amniotic Membrane as an Alternative Method in Psoriasis Treatment

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

Intervention / Treatment
-----------------
* Combination Product: REGE pro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients have psoriasis lesion Exclusion Criteria: must stop other line of treatment

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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: treated<br>Patients who received patches of REGE pro on psoriasis lesion weekly for 8 weeks | Combination Product: REGE pro<br>* REGE pro is a patch of human amniotic membrane sterilized by gamma radiation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scaling size decrement | REGE pro gel decreased scaling size in patients with sever scales to moderate scale within two weeks, scaling size decrement from moderate to mild within two weeks, and from mild to complete curing within two weeks | 2 weeks | 
| Histopathological improvement | Two biopsies were taken from each patient before and at the end of the treatment. It was noted that all histological signs as munro's microabscess and the elongation of rete ridges were absent. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythema disappearing | REGE pro gel gradually decreased erythema in patients within 4-6 weeks, these data were collected from applied patients by questionnaire. | 4-6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amniotic membrane, Psoriasis, Treatment
Varied Practice on LAPSIM

Study Overview
=================
Brief Summary
-----------------
To investigate whether training using a random selection of exercises on a laparoscopic virtual reality simulator results in a stronger retention of skills when using a proficiency-based training program compared to conventional self-directed training.

Official Title
-----------------
Random Selection of Exercises Versus Self-Directed Training, for Laparoscopic Simulator Training - a Randomized Trial

Conditions
-----------------
Skilss Acquisition for Virtual Reality Laparoscopic Training

Intervention / Treatment
-----------------
* Other: Random selection of excercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical Students enrolled at a Danish University Exclusion Criteria: Not being enrolled at a medical program at a Danish University, having participated in other virtual reality studies regarding laparoscopy, have had training or practice in laparoscopy on either pigs or in the clinic, have any medical conditions that may hinder a standard learning process when it comes to skills acquisition (eg. parkinson's disease, limited eye-sight etc).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Intervention<br> | Other: Random selection of excercises<br>* Participants in the intervention group will train using a random selection of excercises and complete the profiency-based traning program.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (minutes) to reach the predefined proficiency settings for the basic skills and the procedural module after 3-6 weeks without laparoscopic training. |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (minutes) to reach the predefined proficiency settings for the basic skills | To examine any difference in training time for the two groups over-all | 6 weeks | 
| Time (minutes) to reach proficiency setting for the procedural module (salpingectomy due to an ectopic bleeding) | To examine if there is any difference in training time (minutes) for the two-groups when practicing on the procedural module (salpingectomy due to an ectopic bleeding) | 6 weeks |
Efficacy and Safety of Meloxicam (Mobicox®) in Mexican Population With Rheumatic Diseases

Study Overview
=================
Brief Summary
-----------------
Study to evaluate the efficacy and safety of meloxicam (Mobicox®) in Mexican population with rheumatic diseases.

Official Title
-----------------
Clinical Therapeutic Evaluation Program in Patients With Rheumatic Diseases

Conditions
-----------------
Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: none Exclusion Criteria: Hypersensitivity to meloxicam or to other NSAIDS History of asthma, angioedema or urticaria secondary to NSAIDS Pregnancy or lactation Recent or current history of peptic ulcer disease, severe renal failure, severe hepatic failure Age below of 12 years.

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- | --- |
| Change in intensity of the symptoms measured with a four-point scale |  | Baseline, 30 and 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of satisfaction evaluated with a six point numerical rating scale |  | up to 90 days | 
| Number of patients with adverse events |  | up to 90 days |
Dose Ranging Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation at various doses in patients with diabetic macular edema.

Official Title
-----------------
A Phase 2, Randomized, Double-Masked, Placebo-Controlled, Dose-Ranging Clinical Study to Assess the Safety and Efficacy of Subconjunctival Injections of Sirolimus in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: Sirolimus
* Drug: Placebo
* Drug: Sirolimus
* Drug: Sirolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria include but are not limited to: Diagnosed with diabetes mellitus Macular edema secondary to diabetic retinopathy Visual acuity of 20/40 to 20/200 in study eye Exclusion Criteria include but are not limited to: Any other ocular disease that could compromise vision in the study eye Any of the following treatments to the study eye within 90 days prior to study start: intravitreal injections; posterior subtenons steroids; focal/grid macular photocoagulation; intraocular surgery Capsulotomy of the study eye within 30 days prior to study start

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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Sirolimus<br>* Two subconjunctival injections of 220 micrograms sirolimus each.<br>* Other names: MS-R003, rapamycin;|
| Experimental: 2<br> | Drug: Sirolimus<br>* Two subconjunctival injections of 440 micrograms sirolimus each.<br>* Other names: MS-R001, rapamycin;|
| Experimental: 3<br> | Drug: Sirolimus<br>* Two subconjunctival injections of 880 micrograms sirolimus each.<br>* Other names: MS-R002, rapamycin;|
| Placebo Comparator: 4<br> | Drug: Placebo<br>* Two subconjunctival injections of placebo.<br>* Other names: Vehicle;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-corrected visual acuity by ETDRS |  | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foveal central subfield thickness as determined by OCT |  | 180 days | 
| Safety across dose groups versus placebo |  | 180 days |
Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl

Study Overview
=================
Brief Summary
-----------------
CONTEXT AND OBJECTIVE: Controversies exist regarding the site of action of Fentanyl after epidural injection. The objective of this investigation was to compare the analgesic effect of epidural and intravenous Fentanyl for lower limb orthopedic surgeries. DESIGN AND SETTING: A randomized and double-blind study was performed in Hospital São Paulo. METHODS: 29 patients were divided into two groups. During the postoperative period, in the presence of pain, group 1 (n = 14) patients received 5 mL of a 100 mcg Fentanyl solution in saline without preservative by the epidural route and 2 mL saline intravenously. Group 2 (n = 15) patients received 5 mL saline by the epidural route and 2 mL (100 mcg) Fentanyl intravenously. Analgesic supplementation consisted of 40 mg intravenous Tenoxicam and 5 mL epidural 0.25% bupivacaine (if pain relief was not achieved with Tenoxicam). Pain intensity was evaluated by numerical scale and plasma concentrations of Fentanyl were measured simultaneously.

Official Title
-----------------
Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl

Conditions
-----------------
Fentanyl Analgesia

Intervention / Treatment
-----------------
* Drug: Fentanyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both genders ranging in age from 18 to 65 years, American Society of Anesthesiologists (ASA) Physical Status 1 or 2, scheduled for orthopedic bone surgery of the lower limbs Exclusion Criteria: Patients with infection in the puncture area and coagulation disorders, pregnant patients, and patients using opioids

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>group 1 (n = 14) patients received 5 mL of a 100 mcg Fentanyl solution in saline without preservative by the epidural route and 2 mL saline intravenously. Group 2 (n = 15) patients received 5 mL saline by the epidural route and 2 mL (100 mcg) Fentanyl intravenously | Drug: Fentanyl<br>* 100 mcg Fentanyl intravenous or epidural route<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fentanyl plasma concentration measure in different times |  | 1year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Analgesia, Fentanyl, Orthopedic, Mechanism of action, Surgery
CHARM: Chronic Hepatitis B Antihepadnaviral Resistance Mutation Study

Study Overview
=================
Brief Summary
-----------------
This study has the aim of describing viral mutation profiles in patients diagnosed with chronic hepatitis B receiving antihepadnaviral therapy.

Detailed Description
-----------------
This is a naturalistic cross-sectional study of chronic hepatitis B subjects receiving nucleoside or nucleotide antihepadnaviral therapy. It is anticipated approximately 800 subjects will be recruited at 20 Australian sites. Data will be collected on the study subjects and analyses performed to describe factors contributing to the emergence of viral mutations in Australian patients with chronic hepatitis B.

Official Title
-----------------
Study of Acquired Viral Mutations in Chronic Hepatitis B Patients on Antihepadnaviral Therapy

Conditions
-----------------
Chronic Hepatitis B

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years and over Provided informed consent Diagnosis of chronic hepatitis B (HBsAg documented for at least 6 months) Currently prescribed antihepadnaviral therapy (including, but not limited to: lamivudine, adefovir, entecavir, tenofovir or telbivudine) for chronic hepatitis B management Been taking current antihepadnaviral therapy for at least 6 months prior to recruitment Negative tests for HIV Ab, Hepatitis C Ab and Hepatitis D Ab within the previous 2 years Exclusion Criteria: Known or suspected co-infection with HIV, Hepatitis C or Hepatitis D Concomitant immunosuppression / immunomodulatory therapies Diagnosis of hepatocellular carcinoma where anticipated life expectancy is less than 6 months Current participation in an interventional, blinded, pharmaceutical industry-sponsored clinical trial Current Child Pugh class C classification (current Child Pugh score > 9) Other known or suspected cause of chronic liver disease Any other reason that, in the investigator's opinion, participation in the study would not be in the participant's best interest.

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 |
| --- | --- |
| 1<br>Single cohort | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive statistics for clinical and viral characteristics of the study population |  | Single timepoint (blood draw) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Hepatitis B
Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037)

Study Overview
=================
Brief Summary
-----------------
This study is designed to compare the efficacy of ertapenem and piperacillin/tazobactam with respect to the clinical response in baseline microbiologically evaluable patients; and to evaluate the tolerability and safety of ertapenem compared to piperacillin/tazobactam.

Detailed Description
-----------------
Original label approved November 2001

Official Title
-----------------
A Prospective, Multicenter, Double-Blind With In-House Blinding, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability of Ertapenem Sodium Versus Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections in Hospitalized Adults

Conditions
-----------------
Complicated Intra-Abdominal Infections

Intervention / Treatment
-----------------
* Drug: MK0826, /Duration of Treatment : 8 Weeks
* Drug: Comparator : piperacillin sodium (+) tazobactam sodium /Duration of Treatment : 8 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients (greater or equal to 18 years of age) Intraoperative/Postoperative Enrollment: Upon visual confirmation of an intra-abdominal infection. Preoperative Enrollment: Patients may be enrolled preoperatively if they meet certain criteria Exclusion Criteria: Failure to meet all inclusion criteria. Patients who are considered unlikely to survive the 6-8 week study period. Pregnant or nursing women, or fertile women not practicing adequate methods of contraception.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0826, /Duration of Treatment : 8 Weeks|nan|
|Drug: Comparator : piperacillin sodium (+) tazobactam sodium /Duration of Treatment : 8 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In microbiologically evaluable patients, ertapenem will be at least as effective as piperacillin/tazobactam at the 2-weeks post-treatment Early Follow-up Assessment. |  | 2-weeks post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In microbiologically evaluable patients, ertapenem will be at least as effective as piperacillin/tazobactam at the 4-6 weeks post-treatment Late Follow-up Assessment. |  | 4-6 Weeks post-treatment |
Effect of Oocyte Vitrification on Fertilization Rate, Embryo Quality and Development

Study Overview
=================
Brief Summary
-----------------
Indications for oocyte (egg) vitrification (fast freezing) include the preservation of reproductive competence of young cancer patients who need chemotherapy, pelvic radiation, or surgical removal of ovaries for treatment. Furthermore, the ability to freeze oocytes allows patients to reduce the number of embryos frozen, thereby circumventing the moral and ethical dilemmas of having left-over embryos in cryostorage. In addition, oocyte cryopreservation could allow women to delay childbearing if they want or need to. Until recently, conventional cryopreservation protocols have remained too inefficient for practical application in an infertility center. Very little is known about the effects of vitrification on oocytes and subsequent embryo development, especially using the sibling model (group of oocytes from the same cohort of ovarian follicles within patient). The purpose of this study is to examine the effect of oocyte vitrification on fertilization rates, embryo quality and development.

Official Title
-----------------
A Study to Compare Vitrified/Warmed Oocytes vs. Fresh Sibling Oocytes Collected Following Controlled Ovarian Stimulation Using Follistim AQ and Ganirelix Acetate on Fertilization Rates, Zygote Quality, Embryo Quality and Embryo Development

Conditions
-----------------
Fertility

Intervention / Treatment
-----------------
* Procedure: Freezing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy women ages 21-37 (inclusive)undergoing IVF in an attempt to achieve pregnancy Day 2-4 FSH < 10 IU/ml, LH <12 IU/ml, and E2 <50 pg/ml Antimullerian Hormone (AMH) >1.5 Between 5 and 20 basal antral follicles on day 2-4 of the menstrual cycle BMI >18 and <32 Exclusion Criteria: Smokers Polycystic Ovarian Syndrome (PCO)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 37 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: freezing<br> | Procedure: Freezing<br>* Vitrification<br>|
| No Intervention: No freezing<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fertilization rate |  | 18 hours after insemination | 
| Embryo Quality |  | day 3 and day 5 | 
| Embryo Development |  | Day 3 and day 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitrification, Egg Freezing, Oocyte Cryopreservation