linjc16/ctgov huggingface dataset:
Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia

Study Overview
=================
Brief Summary
-----------------
Intensive chemotherapy is associated with significant thrombocytopenia, often requiring platelet transfusion to maintain platelet counts. This investigational drug has demonstrated the ability to increase platelet counts. This study will test the safety and efficacy of an investigational drug in the prevention of thrombocytopenia in patients with high-risk sarcoma receiving AI (Adriamycin/Ifosfamide) chemotherapy.

Official Title
-----------------
Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia Administered to Patients With High-Risk Sarcoma Receiving Intensive Chemotherapy (Adriamycin and Ifosfamide (AI))

Conditions
-----------------
Sarcoma

Intervention / Treatment
-----------------
* Drug: PN-152,243)/PN-196,444


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be newly diagnosed with moderate or high-grade sarcoma and be receiving AI (Adriamycin/Ifosfamide) chemotherapy Exclusion Criteria: Patients must not have active bleeding (exclusions do apply) or history of platelet disorder

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PN-152,243)/PN-196,444|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effectiveness of intravenous rhTPO versus placebo in reducing the cumulative proportion of patients who experience severe chemotherapy induced thrombocytopenia. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the effect of rhTPO on the number of platelet transfusions. |  |  | 
| Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO prophylaxis. |  |  | 
| Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia. |  |  | 
| Assess the likelihood that patients were to have adequate hematological recovery to allow on-time chemotherapy administration in the subsequent cycles. |  |  | 
| Assess the safety of multiple IV doses of rhTPO. |  |  | 
| Determine the occurrence and clinical implications of any anti-TPO antibodies. |  |  | 
| Assess the antitumor activity of AI chemotherapy. |  |  | 
| Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness. |  |  | 
| Evaluate the impact of rhTPO prophylaxis on patient quality of life. |  |  | 
| Determine serum concentrations of TPO in the context of rhTPO and chemotherapy administration |  |  |
Alleviation of Cedar Pollen Induced Allergic Symptoms by Orally Taken Superfine Beta-1,3-Glucan

Study Overview
=================
Brief Summary
-----------------
Intravenous- injection of beta-1,3-glucan in human is known to induce T helper type 1 response, while oral uptake did not. It was examined whether superfine dispersed beta-1,3-glucan (SDG) contrived to absorbed by intestinal mucosa would alleviate allergic symptoms by per-oral ingestion

Detailed Description
-----------------
Beta-1,3-glucan made from Japanese mushroom is commercially available for healthy foodstuffs. Allergy patients were orally administrated either SDG (n=30) or non-dispersed beta-1,3-glucan (NDG, n=30) and allergic symptoms were assessed clinically, by the double-blind, placebo-controlled, randomized study

Official Title
-----------------
Alleviation of Cedar Pollen Induced Allergic Symptoms by Orally Taken Superfine Beta-1,3-Glucan - A Double-Blind Randomized Study

Conditions
-----------------
Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: beta-1,3-glucan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of seasonal allergic conjunctivitis with or without rhinitis in spring (Japanese cedar pollen season) every year positive allergen specific IgE (> 30 IU/ml) or positive skin prick test result (wheal diameter > 3mm) to Japanese cedar, Orchard Grass pollen, or house dust-mite extract Exclusion Criteria: Patients who had undergone immunotherapy in the previous 5 years a history of other immunological or medically relevant diseases

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

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: beta-1,3-glucan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms were assessed clinically by score on a allergic symptom rating scale. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total IgE and allergen specific IgE were measured. |  |  | 
| The binding capacity of beta-1,3-glucan to peripheral CD14+ cells were assessed. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allergy, Allergy conjunctivitis, beta-1-3glucan, Th1/Th2
TLK286 (Telcyta) vs. Doxil/Caelyx or Hycamtin in Platinum Refractory or Resistant Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate superiority in survival in favor of TLK286 as compared to active control therapy with Doxil/Caelyx or Hycamtin in the intent-to-treat (ITT) populations.

Official Title
-----------------
Phase 3 Randomized Study of TLK286 (Telcyta) Versus Doxil/Caelyx or Hycamtin as Third-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-1 (Assessment of Survival In Solid Tumors-1)]

Conditions
-----------------
Ovarian Neoplasms

Intervention / Treatment
-----------------
* Drug: TLK286 HCl for injection
* Drug: topotecan hydrochloride for injection
* Drug: doxorubicin HCl liposome injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria include: Considered platinum refractory or resistant according to standard criteria Progressed during or following completion of one second-line treatment with Doxil/Caelyx or Hycamtin Histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube, or primary peritoneal cancer Measurable disease according to RECIST criteria with documented tumor progression Exclusion criteria include: Treatment with second-line chemotherapy other than Doxil/Caelyx or Hycamtin History of whole pelvis radiation therapy within 12 months of enrollment Clinically significant cardiac disease Evidence of gross hematuria at the time of study entry Any signs of intestinal obstruction interfering with nutrition at the time of study entry Pregnant or lactating women

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: TLK286 HCl for injection|nan|
|Drug: topotecan hydrochloride for injection|nan|
|Drug: doxorubicin HCl liposome injection|nan|

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
-----------------
ovary
Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the study is to determine if GARDASIL (V501) with four components is able to prevent cervical cancer, cervical dysplasia, including Cervical Intraepithelial Neoplasia (CIN)(Any Grade) and Adenocarcinoma In Situ (AIS), and genital warts.

Official Title
-----------------
A Study to Evaluate the Efficacy of Quadrivalent HPV Vaccine in Reducing the Incidence of HPV 6-, 11-, 16-, and 18-Related CIN, AIS, and Cervical Cancer, and HPV 6-, 11-, 16-, and 18-Related External Genital Warts, Vulvar Intraepithelial Neoplasia Vaginal Intraepithelial Neoplasia, Vulvar Cancer, and Vaginal Cancer in 16- to 23-Year-Old Women

Conditions
-----------------
Cervical Cancer, Genital Warts

Intervention / Treatment
-----------------
* Biological: V501
* Biological: Comparator: Placebo
* Biological: Human Papillomavirus (HPV) 16 Monovalent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female with an intact uterus with lifetime history of 0-4 sexual partners Exclusion Criteria: Prior Human Papillomavirus (HPV) vaccination Prior abnormal paps History of genital warts

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 23 Years

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

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: 1<br>V501 | Biological: V501<br>* Final Manufactured Product (FMP) quadrivalent HPV vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.<br>|
| Placebo Comparator: 2<br>Placebo | Biological: Comparator: Placebo<br>* a 0.5 mL intramuscular placebo injection given at Day 1, Month 2 and Month 6.<br>|
| Experimental: 3<br>HPV 16 Monovalent Vaccine | Biological: Human Papillomavirus (HPV) 16 Monovalent<br>* HPV 16 Monovalent vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer |  | Follow-up through end of study (4 years) | 
| Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer] |  | Follow-up through end of study (4 years) |
Postoperative Music for Orbital Decompression

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of music to the postoperative pain and discomfort after orbital decompression.

Detailed Description
-----------------
To investigate the effect of music to the postoperative pain and discomfort after orbital decompression under general anesthesia.

Official Title
-----------------
Music for Postoperative Pain and Discomfort After Orbital Decompression

Conditions
-----------------
Surgery, Pain, Musth

Intervention / Treatment
-----------------
* Other: Music
* Other: Routine perioperative treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 16-75 years old diagnosed as thyroid eye disease bone removal orbital decompression under general anesthesia Exclusion Criteria: any uncontrolled clinical problems orbital decompression under local anesthesia Reluctance to participate in clinical trials

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music group<br>Perioperative music intervention | Other: Music<br>* Perioperative musical intervention<br>|
| Active Comparator: Control group<br>No perioperative music | Other: Routine perioperative treatment<br>* Routine perioperative treatment<br>* Other names: Routine perioperative treatment without music;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain after orbital decompression | Pain levels measured using Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable ; this scale has been confirmed to be sensitive and reliable.Clinically significant postoperative pain was considered serious pain (NRS score ≥5). | 24 hour after recovery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discomfort after orbital decompression | Discomfort levels were measured using Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 represents no discomfort and 10 represents the worst discomfort; this scale has been confirmed to be sensitive and reliable. Discomfort was defined as sensation other than pain and included nausea, vomiting, headache, and dizziness. Clinically significant postoperative discomfort was considered serious discomfort (NRS score ≥5) any time postoperatively. | 24 hour after recovery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative pain, postoperative discomfort, general anesthesia
Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment

Study Overview
=================
Brief Summary
-----------------
To investigate the safety and efficacy of methylprednisolone infiltration in anserine bursitis treatment

Official Title
-----------------
Phase 2 Double-blinded, Placebo-controlled, Clinical Trial for Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment

Conditions
-----------------
Bursitis

Intervention / Treatment
-----------------
* Drug: EXPERIMENTAL
* Drug: PLACEBO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of anserine bursitis Exclusion Criteria: Intraarticular pathology that reflects pain in the medial part of the knee

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylprednisolone<br>Infiltration of 40 mg of methylprednisolone acetate plus 1 mL of xylocaine | Drug: EXPERIMENTAL<br>* Infiltration of 40 mg of methylprednisolone acetate plus 1 mL of xylocaine and Diclofenac sodium 100 mg PO QD for 10 days<br>* Other names: DEPOMEDROL;|
| Placebo Comparator: Placebo<br>Infiltration of 1 mL of xylocaine | Drug: PLACEBO<br>* Infiltration of 1 mL of xylocaine and Diclofenac sodium 100 mg PO QD for 10 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC score | The WOMAC (Westren Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee using 24 parameters. It can be used to monitor the course of the disease or to determine the effectiveness of anti-rheumatic medications. Pain, Stiffness and Physical functionVisual analogue scale (VAS) may be used ranging from 0 to 10. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS satisfaction | Visual Analoge Scale for satisfaction | 4 weeks | 
| Improvement | Percentage of improvement | 4 weeks | 
| SAFETY | Pain at infiltration site, ecchymosis, bleeding, paresthesias, skin infection, anaphilaxy, vasovagal reaction | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anserine bursitis
STA-5326 in Crohn's Disease Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and tolerability of STA-5326 given once daily or twice daily to Crohn's Disease patients with moderate disease.

Official Title
-----------------
A Phase I/IIa Trial of STA-5326 in Crohn's Disease Patients With CDAI Scores of 220-450

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: STA-5326


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18-65 years old Crohn's Disease for 6 months CDAI scores between 220-450 +/- 5-ASA, stable dose for > 2 weeks +/- Corticosteroids, less than or equal to 40 mg per day with a stable dose for 2 weeks +/- Infliximab with no treatment within 4 weeks +/- 6-Mercaptopurine, with a stable dose for 8 weeks +/- Antibiotics, with a stable dose for 2 weeks Exclusion Criteria: Patients who have had methotrexate, cyclosporine, or other experimental drug within 3 months of screening Pregnancy, breast feeding History of total proctocolectomy with stoma. Previous ileocolectomy would not be a contraindication to the study Bowel obstruction Surgical bowel resection within 90 days Total parenteral nutrition (TPN), CYA, tacrolimus

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: STA-5326|nan|

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
-----------------
Crohn's Disease
Platelet-rich Plasma (PRP) Treatment for Medial Retinaculum Tear Post Medial Patellar Dislocation

Study Overview
=================
Brief Summary
-----------------
To check the influence of injected platelet-rich plasma (PRP) on the healing of medial retinaculum and the redaction in recurrent dislocation of the patella.

Detailed Description
-----------------
Autologous platelet-rich matrices may aid in the healing of ligaments & tendons by promoting and accelerating tissue healing because of the release of growth factors including transforming growth factor (TGF)-beta1 and platelet-derived growth factor (PDGF) from platelet alpha-granules.

Official Title
-----------------
PRP Treatment for Medial Retinaculum Tear - Randomized-Double-Blind-Placebo Control Trail

Conditions
-----------------
Patella-Dislocation

Intervention / Treatment
-----------------
* Biological: Plasma Rich in Growth Factors (PRGF)
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-40 years old first time patella dislocation Exclusion Criteria: pregnancy mental or physical disabilities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Placebo Comparator: 2<br>saline | Drug: placebo<br>* injection of 6 cc of saline into injured area<br>* Other names: saline 0.9% NaCl;|
| Experimental: 1<br>Plasma Rich in Growth Factors (PRGF) | Biological: Plasma Rich in Growth Factors (PRGF)<br>* US guided IM injection 3-6mg<br>* Other names: platelet-derived preparation rich in growth factors;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| redaction in healing time and recurrence |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
medial retinaculum tear s/p patella dislocation
Intraoperative Sedation and Postoperative Delirium

Study Overview
=================
Brief Summary
-----------------
Delirium are common after orthopedic surgery in the elderly and are directly associated with loss of independence, reduction in the quality of life and increased mortality. The cause of postoperative delirium still remains unclear and may be multifactorial. The aim of this retrospective study is to examine prevalence of postoperative delirium according to the use of dexmedetomidine or propofol in elderly patients undergoing orthopedic surgery under regional anesthesia.

Official Title
-----------------
Prevalence of Postoperative Delirium According to the Use of Dexmedetomidine or Propofol in Elderly Patients Undergoing Orthopedic Surgery: Retrospective Study

Conditions
-----------------
Orthopedics

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent orthopedic surgery under regional anesthesia age of 65 years or greater Exclusion Criteria: General anesthesia age < 65 years central nervous system disease, including dementia and Parkinson's disease Patients who were not received sedation with propofol or dexmedetomidine during the operation

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| DEX<br>patients who received dexmedetomidine during the operation | Drug: Dexmedetomidine<br> <br> |
| PPF<br>patients who received propofol during the operation | Drug: Propofol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delirium |  | within 7 day postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound infection |  | within 7 day postoperatively | 
| Pulmonary thromboembolism |  | within 7 day postoperatively | 
| Hospital stay |  | through study completion, an average of 7days |