linjc16/ctgov huggingface dataset:
Twelve Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Adults

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the effectiveness in adults, of four different strengths of resiquimod gel applied to common wart(s) three times a week for twelve weeks. A second purpose is to evaluate the safety of the drug.

Official Title
-----------------
A Three-Stage, Modified-Blind, Dose-Escalating Study to Assess Efficacy and Safety of Resiquimod Gel for the Treatment of Common Warts in Adults

Conditions
-----------------
Warts

Intervention / Treatment
-----------------
* Drug: Resiquimod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of common warts Two forms of birth control Exclusion Criteria: Pregnant or breast feeding Other types of wart(s), ie. plantar Currently participating in another clinical study Chronic viral hepatitis B or C

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Resiquimod|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance of treated common wart(s) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial clearance of treated common wart(s) |  |  | 
| Wart recurrence |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wart(s), Adults, Common Wart(s)
Immunogenicity and Safety Study of NBP606 in Healthy Infants

Study Overview
=================
Brief Summary
-----------------
This study will assess the immunogenicity and safety of primary vaccination with NBP606 compared to the existing commercial vaccine, when given concomitantly with routine pediatric vaccinations.

Official Title
-----------------
Multi-Center, Randomized, Double-Blind, Phase III Trial to Assess the Immunogenicity and Safety of Primary Vaccination With NBP606 in Healthy Infants

Conditions
-----------------
Pneumococcal Infections

Intervention / Treatment
-----------------
* Biological: NBP606
* Biological: Prevnar13


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Infants between 42 and 98 days of age (approximately 2 months) at the time of enrollment. The LAR (Legally Authorized Representative) who understand the requirements of the study and voluntarily consent to participate in the study. Exclusion Criteria: Known hypersensitivity to any components of the pneumococcal vaccine Any confirmed or suspected immunosuppressive or immunodeficient conditions Coagulation disorder contraindicating IM(intramuscular) vaccination Subject has received any licensed vaccine(not including BCG and Hepatitis B) Participation to another study

Ages Eligible for Study
-----------------
Minimum Age: 42 Days
Maximum Age: 98 Days

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NBP606<br>13-valent pneumococcal conjugate vaccine | Biological: NBP606<br>* A single intramuscular injection into the thigh<br>|
| Active Comparator: Prevnar13<br>13-valent pneumococcal conjugate vaccine | Biological: Prevnar13<br>* A single intramuscular injection into the thigh<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with the targeted antibody concentration |  | 1 month after the primary vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean concentration ratio |  | 1 month after the primary vaccination |
Retrospective Evaluation of the Effect of Iron (Fe) Infusion on Complications in Anemic Patients Undergoing Thoracotomy

Study Overview
=================
Brief Summary
-----------------
In patients who underwent thoracotomy due to lung malignancy; It is desired to investigate whether there is a difference in terms of postoperative results between those with and without anemia, and those with iron deficiency anemia (IDA) who underwent intravenous iron replacement and those who did not, according to the hemoglobin value in their preoperative examinations.

Official Title
-----------------
Retrospective Evaluation of the Effect of Iron (Fe) Infusion on Complications in Anemic Patients Undergoing Thoracotomy

Conditions
-----------------
Iron Deficiency Anemia, Iron Deficiency Anemia Treatment

Intervention / Treatment
-----------------
* Other: iron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: thoracotomy patients Exclusion Criteria: emergency cases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| anemia, treatment<br>anemic patients who had iron therapy | Other: iron<br>* iron treatment<br>|
| anemia, no treatment<br>anemic patients who had no therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients who had postoperatiive complication | postoperative complication | 3 days | 
| number of patients who received blood products | use of blood product | 3 days |
Safety and Tolerability of Repeat Courses of IM Alefacept

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether repeat courses of alefacept, administered intramuscularly, are safe when given to chronic plaque psoriasis patients who are receiving standard dermatology treatments.

Official Title
-----------------
An Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of Repeat Courses of Intramuscular Administration of Alefacept (LFA-3/IgG1 Fusion Protein) in Patients With Chronic Plaque Psoriasis

Conditions
-----------------
Chronic Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: Alefacept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent. At least 16 years of age. Diagnosed with chronic plaque psoriasis and require systemic therapy. CD4+ lymphocyte counts at or above the lower limit of normal for Covance Central Laboratory Services, Inc., unless on a stable dose of prednisone (counts must be at or above 300 cells/mm3). Exclusion Criteria: Unstable erthrodermic or pustular psoriasis. Diagnosis of guttate psoriasis. Serious local infection or systemic infection within 3 months prior to first dose of alefacept. Positive for HIV antibody. Known invasive malignancy within 5 years of enrollment. Patients with a history of treated squamous cell and/or basal cell carcinomas limited to the skin are not excluded. Evidence of active tuberculosis. Current treatment for active tuberculosis or tuberculosis prophylaxis. Female patients unwilling to practice effective contraception as defined by the investigator. Female patients who are pregnant or breast-feeding. Current enrollment in any other investigational drug study. Previous participation in this study or previous alefacept studies.

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Alefacept|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of infections, malignancies, serious adverse events, adverse events leading to discontinuation of study drug, dose withholding (due to infection or decreased T cells), and changes in lymphocyte counts over time. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients who achieve a Physician Global Assessment (PGA) of almost clear or clear over time; the duration of the response to alefacept (the amount of time after alefacept treament before re-treatment with alefacept is necessary). |  |  |
Efficacy and Safety of Biocellulose Sheet Containing Anti-hyperpigmentation Agent (Biocellulose Mask, Farhorm®) in Patients Receiving Laser Treatment

Study Overview
=================
Brief Summary
-----------------
The laser areas treated with biocellulose sheet from coconut juice containing anti-hyperpigmentation agent (biocellulose mask, Farhorm®) heal faster than vaseline ointment which is a standard treatment.

Detailed Description
-----------------
Volar surface at upper arm (2X2 cm) on both sides were treated with semi ablative, 1,550 nm Erbium: glass fractional laser. Biocellulose sheet from coconut juice containing anti-hyperpigmentation agent (biocellulose mask,Farhorm®)was applied for 20 min on one side and the other side was treated with vaseline ointment. The redness, skin hydration and skin pigmentation were evaluated at that area before laser, immediately after laser and after applying the treatment. These parameters were compared between treatment (area treated with Biocellulose sheet from coconut juice containing anti-hyperpigmentation agent, biocellulose mask, Farhorm®) and control (vaseline ointment).

Official Title
-----------------
Efficacy and Safety of Biocellulose Sheet From Coconut Juice Containing Anti-hyperpigmentation Agent (Biocellulose Mask, Farhorm®) in Patients Receiving Laser Treatment

Conditions
-----------------
Skin Pigmentation, Skin Irritation

Intervention / Treatment
-----------------
* Device: Biocellulose Mask, Farhorm®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20-50 years old No skin problem such as inflammation, fresh wounds Not receive laser treatment during last 3 months No history of smoking or alcohol drinking No allergy to licorice extract, Vit C, Vit E, arbutin or stearyl glycyrrhetinate Willing to participate in this study and can comply with study protocol Exclusion Criteria: Has history of hyperallergic reaction Has wound(s) on face during last 4 weeks Has history of eczema, psoriasis during last 6 months Has laser treatment during last month Use steroid, antibiotic, anti-inflammatory drugs or antihistamine during 3 days before recruiting Had major surgery during last 12 months Has history of cancer during last 12 months Pregnant or lactation

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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

| Intervention/Treatment |
| --- |
|Device: Biocellulose Mask, Farhorm®|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The skin pigmentation immediately after laser therapy and after using biocellulose mask |  | Change from immediately after laser treatment and 30 min after laser and treatment with mask |
Suan Tsao Jen Tang for Treating Menopause With Sleep Problem: a Clinical Observation

Study Overview
=================
Brief Summary
-----------------
A prospective follow-up study was carried out in the Yang Ming branch of the Taipei City Hospital.Climacteric women with sleep difficulty received SZRT at a rate of 4.0 g, thrice daily for four weeks.

Detailed Description
-----------------
A prospective follow-up study was carried out in the Yang Ming branch of the Taipei City Hospital between April 2008 and April 2010. Sixty-seven climacteric women with sleep difficulty received SZRT at a rate of 4.0 g, thrice daily for four weeks. Baseline scores were measured on the Pittsburg Sleep Quality Index (PSQI), followed by further measures at the end of weeks one and four. The World Health Organization Quality of Life (WHOQOL) assessment and the Menopause Rating Scale (MRS) were undertaken as secondary outcomes. Regression models were constructed to explore the score differences between the baseline and at weeks one and four by various determinants including age, body mass index (BMI), and severity of baseline menopausal symptoms. Among 99 surveyed patients, 67 and 61 were screened for intention to treat (ITT) and per-protocol population set analysis, respectively. Statistically significant reductions in the PSQI index scores evidenced on the fourth week.

Conditions
-----------------
Menopausal and Female Climacteric States

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Climacteric women, ranging from 40-65 years of age Pittsburg Sleep Quality Index (PSQI) of greater than six Falling asleep more than 45 minutes or slept less than six hours Exclusion Criteria: Within three months of the study there had been a major incident Working the nightshift Lack of time or timing conflicts Pychosis, severe depression, obstructive sleep apnea-hypopnea, cardiac arrhythmia, acute myocardial infarction, high blood pressure, diabetes, or cancer Currently taking pharmaceuticals that affect melatonin, acetylcholine, glutamate, serotonin, norepinephrine, GABA, histamine, adenosine, or prostaglandins Inability to read and fill out the forms for the study Any evidence of renal or liver dysfunction as defined by a level of at least 1.5 times of the upper reference limit

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Suan Zao Ren Tang, climacteric, PSQI, WHOQOL-BREF
A Combination Study With Ridaforolimus (MK8669) and Dalotuzumab (MK0646) in Patients With Advanced Cancer (8669-004)

Study Overview
=================
Brief Summary
-----------------
This study is being done to find the best tolerated dose of ridaforolimus and dalotuzumab in patients who have advanced cancer and to observe any anti-tumor activity in these patients.

Detailed Description
-----------------
Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009

Official Title
-----------------
A Phase I Study of Ridaforolimus (MK8669) and MK0646 in Patients With Advanced Cancer

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: Comparator: ridaforolimus + dalotuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: You must have confirmed metastatic or advanced cancer that has not responded to standard therapy or where standard therapy does not exist In Part C, patients must have a diagnosis of advanced or metastatic colorectal adenocarcinoma or non-small cell lung cancer, and must have received at least 1 but no more than three prior systemic therapy treatment regimens You must be over the age of 18 years old You must have a ECOG status performance of 0 or 1 You must have good organ function You must be willing to have skin and/or tumor biopsies Exclusion Criteria: You have had cancer treatment within 4 weeks prior to entering the study or you still have bad side effects from previous therapies You have an active infection that requires treatment You are HIV positive or have a history of Hepatitis B or C

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ridaforolimus (MK8669) + dalotuzumab (MK0646) | Drug: Comparator: ridaforolimus + dalotuzumab<br>* Starting dose of oral ridaforolimus is 10 mg/day, QD, for five days. Dose rising up to 40 mg/day, QD for five days. Dose range for intravenous dalotuzumab is 7.5 mg/kg/week, 10 mg/kg/week or 7.5 mg/kg/every 14 days. Dalotuzumab will be given as an IV infusion over 1 or 2 hour(s).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the toxicity profile, maximum tolerated dose and recommended phase II dose. |  | MTD from Day 1 to Day 28 in Cycle 1 for disease progression | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure pharmacokinetic and pharmacodynamic parameters with oral ridaforolimus as a single agent and in combination with dalotuzumab |  | At prescribed timepoints as defined in the protocol |
Characterization of Beta Cell Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterise beta cell function in subjects who despite taking part in a diabetes prevention program (life style intervention with diet and exercise) exhibit impaired glucose tolerance and beta cell dysfunction.

Detailed Description
-----------------
We have identified a subgroup of individuals with a good compliance to lifestyle intervention to prevent diabetes who lose body weight and increase insulin sensitivity, however they remain impaired glucose tolerant. These individuals show a deterioration in insulin secretory function. We will identify a highly selected group of subjects with prediabetes that displays a large defect in insulin secretory function.We will study 50 individuals who display these characteristics and 50 subjects who do not display these characteristics. Their insulin secretion capacity in response to different secretagogues (glucose, GLP-1, arginine) will be studied. We expect to detect new pathophysiologic aspects that lead to beta cell failure particularly in this group.

Conditions
-----------------
Diabetes, Metabolic Syndrome

Intervention / Treatment
-----------------
* Drug: GLP-1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Impaired glucose tolerance BMI 16-40 kg/m² Exclusion Criteria: chronic disease anemia therapy with insulin or cortisone

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLP-1<br> | Drug: GLP-1<br>* intravenous, 124,5 pmol/kg body weight<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin secretion |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IGT, IFG
Pain and Suction Curettage

Study Overview
=================
Brief Summary
-----------------
Aim of the study was to investigate the analgesic efficacy of preoperative oral dexketoprofen trometamol, intravenous paracetamol, lidocaine spray and paracervical block with ultracaine on curettage procedure.

Conditions
-----------------
Curettage, Analgesia, Paracervical Block, Paracetamol

Intervention / Treatment
-----------------
* Drug: paracetamol
* Drug: dexketoprofen trometamol
* Drug: suction curettage
* Drug: suction curettage
* Other: without drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant participants between 35-48 days of gestation (5 to 7 weeks of gestation) pregnant participants with a single viable intrauterine pregnancy requesting termination of pregnancy. Exclusion Criteria: incomplete abortions, diabetes mellitus, tendency to bleed such as thrombocytopenia, factor deficiency and functional disorders of platelets… etc, pelvic infection, known cervical stenosis, significantly impaired respiratory or cardiac conduction functions, active liver disease, renal disease, previous adverse reaction to any of the drugs used in the study, and patients who are unable to understand how to score a 10-cm visual analog scale (VAS) pain score. Moreover, patients who described chronic pelvic pain prior to the study or patients who rated their pain level on a continuous 100-mm VAS different from 0 (no pain) just before the study were not included into study.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: paracetamol<br>Duration | Drug: paracetamol<br> <br> |
| Active Comparator: without drug<br>Control group | Other: without drug<br> <br> |
| Active Comparator: dexketoprofen trometamol<br>Study group | Drug: dexketoprofen trometamol<br> <br> |
| Active Comparator: two puff xylocain administration on cervical surface<br>Study group | Drug: suction curettage<br> <br> * Other names: two puff xylocain administration;|
| Active Comparator: paracervical block with ultracaine<br>study group | Drug: suction curettage<br> <br> * Other names: paracervical block with ultracaine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain reduction |  | nine months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Curettage, analgesia, paracervical block, paracetamol, lidocaine, Dexketoprofen trometamol