linjc16/ctgov huggingface dataset:
Risk Benefit Ratio of Hirudotherapy: Retrospective Single-center Study of 37 Cases Over a Period of 9 Years

Study Overview
=================
Brief Summary
-----------------
Venous congestion in transplanted or re-implanted tissues remains a common and chal-lenging complication in plastic and reconstructive surgery. Local application of medicinal leeches is effective to reduce postoperative venous congestion of the flap and to restore normal blood flow. However, leech therapy is associated with a number of risks, including infections. Indeed, leeches maintain a symbiotic relationship with Aeromonas species in order to digest blood in their gut. Aeromonas spp. infections can occur 1 to 30 days post-application of leeches and are associated with a dramatic decrease in flap salvage rates (88 to 30%). For these reasons, prophylactic antibiotics and, external decontamination are widely recommended throughout the course of leech therapy. The aim of this study is to investigate the prevalence of side effects (anemia and infection) from patients treated with leeches in French Hospital.

Official Title
-----------------
Risk Benefit Ratio of Hirudotherapy: Retrospective Single-center Study of 37 Cases Over a Period of 9 Years

Conditions
-----------------
Leeches, Healthcare Associated Infection

Intervention / Treatment
-----------------
* Other: Leech Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who received leeches (for more than 2 days) at the Amiens University Hospital over a period of 9 years (2010-2018) Exclusion Criteria: Hirudotherapy outside the inclusion period Hirudotherapy or less than 2 days of treatment

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| Aeromonas infection<br> | Other: Leech Therapy<br>* Patient who received leeches (for more than 2 days) at the Amiens University Hospital over a period of 9 years (2010-2018)<br>|
| No infected<br> | Other: Leech Therapy<br>* Patient who received leeches (for more than 2 days) at the Amiens University Hospital over a period of 9 years (2010-2018)<br>|
| bacterial infection<br> | Other: Leech Therapy<br>* Patient who received leeches (for more than 2 days) at the Amiens University Hospital over a period of 9 years (2010-2018)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients requiring a second surgery |  | 9 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Leeches, Healthcare-associated infection, Hirudo Medicinalis
Neoadjuvant Dalpiciclib Plus Aromatase Inhibitors or Chemotherapy in Luminal B/HER2-negative Breast Cancer (DAPATH)

Study Overview
=================
Brief Summary
-----------------
Compare the efficacy and safety of Dalpiciclib combined with aromatase inhibitors versus chemotherapy as a neoadjuvant therapy in Luminal B/HER2-negative breast cancer, and explore the predictive biomarkers of the response to the two neoadjuvant therapies.

Official Title
-----------------
Comparison of Efficacy and Safety of Neoadjuvant Dalpiciclib Combined With Endocrine Therapy and Neoadjuvant Chemotherapy in Luminal B/HER2-negative Breast Cancer and Biomarker Analysis: a Prospective, Randomized, Open-label, Blinded Endpoint (PROBE) Trial.

Conditions
-----------------
Luminal B/HER2-negative Breast Cancer

Intervention / Treatment
-----------------
* Drug: Dalpiciclib combined with aromatase inhibitors
* Drug: anthracycline-cyclophosphamide followed by taxane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is ≥ 18 years-old at the time of consent to participate this trial Famale stage I-IIIA breast cancer patients or T4bN0-2M0 HR-positive, HER2-negtive invasive breast cancer, Ki67≥20% or PgR<20% No prior anti-cancer treatment ECOG 0-1 Exclusion Criteria: Known to have other aggressive malignant tumor in the past 5 years. Bilateral breast cancer; Inflammatory breast cancer; Occult breast cancer; Distant metastasis confirmed by pathology. There are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia. Female patients during pregnancy or lactation. The investigator determines that subjects are not appropriate to participate in the study due to other factors.

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
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: neoadjuvant endocrine therapy<br>CDK4/6 inhibitor combined with aromatase inhibitor | Drug: Dalpiciclib combined with aromatase inhibitors<br>* Dalpiciclib combined with letrozole or anastrozole<br>|
| Active Comparator: neoadjuvant chemotherapy<br>anthracycline-cyclophosphamide followed by taxane | Drug: anthracycline-cyclophosphamide followed by taxane<br>* 4 cycles of anthracycline-cyclophosphamide (EC) followed by 4 cycles of taxane<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| residual cancer burden |  | 3 years |
Satavaptan for the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver

Study Overview
=================
Brief Summary
-----------------
Primary: To evaluate the efficacy of satavaptan in the absence of concomitant diuretic drugs in reducing the recurrence of ascites. Secondary: To evaluate the tolerability and safety of satavaptan in the absence of concomitant diuretic drugs over a 52-week treatment period in patients with cirrhosis of the liver and recurrent ascites. The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

Official Title
-----------------
Satavaptan in the Prevention of Ascites Recurrence: a Double-blind, Randomised, Parallel-group Comparison of Satavaptan at 5 to 10 mg Daily Versus Placebo in the Absence of Diuretics in Patients With Recurrent Ascites Due to Cirrhosis of the Liver.

Conditions
-----------------
Ascites, Liver Cirrhosis

Intervention / Treatment
-----------------
* Drug: Satavaptan
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cirrhosis of the liver. Patients resistant to the effects of diuretics, intolerant of diuretics or otherwise unsuitable for treatment with diuretics according to the judgement of the investigator. Patients with recurrent ascites having undergone both of the following: therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of = or > 4 litres of fluid. at least one other therapeutic paracentesis in the previous 3 months. Exclusion Criteria: Patients with an existing functional transjugular intrahepatic portosystemic shunt (TIPS) or other shunt. Known hepatocellular carcinoma. Patients with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma Patients previously exposed to satavaptan in the past 12 months.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Satavaptan<br> | Drug: Satavaptan<br>* oral administration once daily<br>* Other names: SR121463B;|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* oral administration once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and time of recurrences of therapeutic paracenteses |  | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from randomisation to first recurrence of ascites |  | study period | 
| Increase in ascites |  | over 12 weeks |
Cephalic Vascular Recording Upon SPG Stimulation

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Stimulation of the SPG at high frequencies (50-200Hz) is believed to cause a physiological parasympathetic block which decreases VMCA oxyHb concentration and cephalic vessel diameter. Stimulation of the SPG at low frequencies (1-60 Hz)is believed to cause a physiological parasympathetic upregulation which increases VMCA, oxyHb concentration and cephalic vessel diameter.

Detailed Description
-----------------
Efferent

Official Title
-----------------
Cephalic Vascular Recording Upon SPG Stimulation in CH Patients - Amendment to the Pathway CH-1 Trial

Conditions
-----------------
Chronic Cluster Headache

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: •Subject is currently enrolled in Pathway CH-1 (CIP-001) Exclusion Criteria: •Subject is NOT currently enrolled in Pathway CH-1(CIP-001)

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?
-----------------
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
-----------------
Chronic Cluster Headache
The Safety and Immunogenicity of Acellular Pertussis Vaccine in Bone Marrow Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if pertussis (whooping cough) vaccine is safe and produces an appropriate immune response against pertussis in blood and marrow transplant patients.

Official Title
-----------------
Safety and Immunogenicity of Adult Formulation Tetanus and Diphtheria Toxoids Adsorbed Combined With Acellular Pertussis (Tdap) Vaccine Following Blood and Morrow Transplantation in Adults

Conditions
-----------------
Pertussis

Intervention / Treatment
-----------------
* Biological: Tetanus and Diphtheria Toxoids Adsorbed Combined with Acellular Pertussis (Adacel)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-64 BMT at the QEII Health Sciences Centre BMT within last 12 months Able to read and write English language Able to give consent Exclusion Criteria: Active infection Active GVHD Recent IVIG Allergy to components of vaccine Diphtheria or tetanus vaccination within 18 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Tetanus and Diphtheria Toxoids Adsorbed Combined with Acellular Pertussis (Adacel)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the vaccine |  | 28 days post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity of vaccine |  | 60 days post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pertussis, bone marrow transplant
Turkish Reliability and Validity of FOPQC-SF

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to question the Turkish validity and reliability of the The Fear of Pain Questionnaire for Children Short Form (FOPQC-SF) scale. Children/adolescents between the ages of 7-18 and diagnosed with Juvenile Idiopathic Arthritis followed by the Pediatric Rheumatology Clinic will be included in the study. The sample size of this study was determined as at least 50. To assess the validity of the FOPQC-SF scale, participants will be administered the Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module, the Childhood Health Assessment Questionnaire (CHAQ), and the Juvenile Arthritis Disease Activity Score.

Official Title
-----------------
Turkish Reliability and Validity of The Fear of Pain Questionnaire for Children Short Form (FOPQC-SF) in Children/Adolescents With Juvenile Idiopathic Arthritis

Conditions
-----------------
Fear, Pain, Juvenile Idiopathic Arthritis

Intervention / Treatment
-----------------
* Other: Fear of Pain Questionnaire for Children Short Form


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being diagnosed with JIA according to the ILAR classification 7-18 years old Agree to participate in the study Exclusion Criteria: Psychiatric illness that may affect cooperation, Those with heart failure and lung pathology at a level that will affect their daily life activities

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br> | Other: Fear of Pain Questionnaire for Children Short Form<br>* administering the questionnaire twice, one week apart.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear of Pain Questionnaire for Children Short Form | It consists of 10 items in total. All items are scored between O-4. Higher scores indicate higher levels of pain-related fear and avoidance. | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module | Total score ranging from 0-100. High scores mean high quality of life. | 15 minutes | 
| Juvenile Arthritis Disease Activity Score | Total JADAS score ranging from 0-57. Higher score indicates more disease activity. | 10 minutes | 
| Childhood Health Assessment Questionnaire | It consists of 8 subtests and 30 questions. It is scored between 0-3. A higher score indicates more disability. | 15 minutes |
A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection

Study Overview
=================
Brief Summary
-----------------
Protocol HECT00306 aims to determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting from Zemplar (paricalcitol injection) for the treatment of secondary hyperparathyroidism in Stage 5 chronic kidney disease on hemodialysis.

Official Title
-----------------
A Phase 4, Multi Center, Open-Label, Randomized Study to Determine Clinically Appropriate Doses of Hectorol® (Doxercalciferol Capsules) When Converting From Zemplar® (Paricalcitol Injection) for the Treatment of Secondary Hyperparathyroidism in Stage 5 Chronic Kidney Disease (CKD) Subjects on Hemodialysis.

Conditions
-----------------
Secondary Hyperparathyroidism

Intervention / Treatment
-----------------
* Drug: Hectorol (doxercalciferol capsules)
* Drug: Zemplar (paricalcitol injection)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject must be receiving hemodialysis three times per week for a minimum of six months. The subject must have been receiving Zemplar Injection for a minimum of 3 months. The subject must have been on a stable dose regimen, three times per week administration for a minimum of four weeks. The central laboratory assessment must be within the following ranges: serum iPTH between 150-600 pg/mL, inclusive; corrected calcium < 10.0 mg/dL; phosphorus < 7.0 mg/dL. Exclusion Criteria: In the opinion of the Investigator, the subject currently has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any other clinically significant, unstable medical condition. Abnormal liver function as measured by ALT/AST greater than two times the upper limit of normal (ULN). The subject currently has malabsorption, severe chronic diarrhea, or ileostomy. Any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not an exclusion.

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Hectorol (doxercalciferol capsules)|nan|
|Drug: Zemplar (paricalcitol injection)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose Conversion |  | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hectorol (doxercalciferol capsules), Zemplar (paricalcitol injection)
Analgesic Effect of Trigger Point Injection and EMLA for Shoulder Pain in Laparoscopic Hysterectomy

Study Overview
=================
Brief Summary
-----------------
Laparoscopic operative procedures have revolutionized gynecological surgery. These have several advantages: a smaller and more cosmetic incision, reduced blood loss and shorter postoperative stay, which cuts down on hospital costs. However, postoperative pain continues to be one complication, which results in an unpleasant experience for the patient and at times causes a delayed discharge. Trigger point injection removes the pain developing point and block the pain signal. EMLA cream shows analgesic effect when being spread on the skin. An literature showed that patch of local anesthetics showed the effect of trigger point inject. The purpose of this study is to investigate the alleviation of shoulder pain, headache, abdominal pain, and back pain after trigger point injection or EMLA cream applying on shoulder in patients undergoing total laparoscopic hysterectomy.

Conditions
-----------------
Myoma of Uterus

Intervention / Treatment
-----------------
* Drug: TPI
* Drug: EMLA cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA class I or II age 20 70 patients undergoing total laparoscopic hysterectomy Exclusion Criteria: history of shoulder surgery coagulopathy infection or trauma of shoulder general inflammation allergy to local anesthetics

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TPI group<br> | Drug: TPI<br>* Trigger point injection with 25G needle on the shoulder before surgery(0.5% procaine, 0.25 0.5% lidocaine, 0.125% bupivacaine)<br>* Other names: Trigger Point Injection;|
| Active Comparator: ELMA group<br> | Drug: EMLA cream<br>* EMLA cream with occluding dressing on the shoulder before surgery(5% of eutectic mixture with 2.5% lidocaine and 2.5% prilocaine)<br>|
| No Intervention: None group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative shoulder pain | Postoperative shoulder pain is measured using the VAS at 3 hr after end of surgery. | 3 hr after end of surgery |
The Comparison of Effect of Four Different Treatment Protocols on IVF Outcomes in Poor Responders Undergoing in Vitro Fertilization.

Study Overview
=================
Brief Summary
-----------------
The comparison of effect of four different treatment protocols: Antagonist/letrozole protocol, microdose flare-up protocol, Antagonist/clomiphene protocol, Antagonist on IVF outcomes in poor responders undergoing in vitro fertilization; a prospective randomized-controlled study.

Official Title
-----------------
The Comparison of Effect of Four Different Treatment Protocols: Antagonist/Letrozole Protocol, Microdose Flare-up Protocol, Antagonist/Clomiphene Protocol, Antagonist on IVF Outcomes in Poor Responders Undergoing in Vitro Fertilization; a Prospective Randomized-controlled Study.

Conditions
-----------------
Poor Responders Undergoing IVF

Intervention / Treatment
-----------------
* Drug: GnrH Antagonist/letrozole protocol (Cetrotide; serono + Femara; Novartis Pharma AG)
* Drug: microdose flare-up protocol (Lucrin; Abbott + Gonal F, Serono)
* Drug: Antagonist/clomiphene protocol (Cetrotide; serono + Klomen, Kocak pharma)
* Drug: GnRH antagonist protocol (Cetrotide, Serono)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Criteria for definition of poor responders included at least one of the following Anti müllerian hormone <1.1 ng/ml and/or a previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol). Primary infertile patients BMI≤30 kg/m2 were included this study. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVF patients<br>patients that has applied to Yeditepe University Hospital assisted reproduction center | Drug: GnrH Antagonist/letrozole protocol (Cetrotide; serono + Femara; Novartis Pharma AG)<br> <br> Drug: microdose flare-up protocol (Lucrin; Abbott + Gonal F, Serono)<br> <br> Drug: Antagonist/clomiphene protocol (Cetrotide; serono + Klomen, Kocak pharma)<br> <br> Drug: GnRH antagonist protocol (Cetrotide, Serono)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rates |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total number of oocytes retrieved |  | 6 months |