linjc16/ctgov huggingface dataset:
Use of Myo-inositol as Adjuvant Therapy in Patients With Polycystic Ovary Syndrome (PCOS) in Vitro Fertilization (IVF)

Study Overview
=================
Brief Summary
-----------------
The original mechanism of action of myo-inositol and preliminary results available in the literature on its use in IVF suggest its value as adjuvant gonadotropin therapy to reduce the risk of OHSS in PCOS patients. The aim of the study is to demonstrate that administration of myo-inositol decreases the incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk infertile with PCOS supported in IVF patients.

Official Title
-----------------
Use of Myo-inositol as Adjuvant Therapy in Patients With Polycystic Ovary Syndrome (PCOS) in Vitro Fertilization (IVF)

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: Inofolic®
* Other: Gonadotropins; Folic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients PCOS (Rotterdam ESHRE / ASRM criteria) Combination of at least two of the following three criteria: Cycle disorder Clinical hyperandrogenism and / or biological Account antral follicles> 24 Age ≤ 18 ≤ 38 years BMI <35 kg / m² Able to understand the protocol and signed informed consent Exclusion Criteria: Patients not having the Rotterdam criteria Patients> 38 years and / or BMI> 35 kg / m² Woman enjoying a measure of legal protection Hypersensitivity to any component of the Inofolic (myo-inositol, soy, folic acid, glycerol, gelatin, coloring E171) Participation in another interventional biomedical research with treatment administered may disrupt ovarian stimulation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inofolic®<br>standard ovarian stimulation and Inofolic® | Dietary Supplement: Inofolic®<br> <br> Other: Gonadotropins; Folic Acid<br>* standard ovarian stimulation<br>|
| Active Comparator: Gonadotropins;Folic Acid<br>standard ovarian stimulation without Inofolic® | Other: Gonadotropins; Folic Acid<br>* standard ovarian stimulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of OHSS in each group, graded mild, moderate or severe based on the recommendations |  | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
in vitro fertilization, ovarian hyperstimulation, pregnancy
Pillow Use During Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out whether placing a pillow between the legs during hip surgery will result in a better aligned hip replacement.

Detailed Description
-----------------
During hip replacement surgery the cup is placed on specific planned angles. Cup placement has an effect on the patients' pain-free range of movement, dislocation rates and satisfaction. However, the angles of the cup orientation (i.e. the tilt and rotation), which are preoperatively planned and postoperatively measured on radiographs, have a high variability even when an experienced surgeon is performing the surgery. One of the reasons this occurs is because the operated leg can move the pelvis to a different position in the time between set-up and actual implantation which may lead to the cup being placed in a non-optimal position. This study aims to see if the difference between planned and achieved cup angles and pelvic movement can be lessened by putting a pillow in between the legs to keep it in a stable horizontal position.

Official Title
-----------------
Can the Difference Between the Operative and Radiographic Cup Inclination Angle Be Reduced by Applying a Pillow Between the Patient's Legs in Total Hip Arthroplasty Performed In The Lateral Decubitus Position?

Conditions
-----------------
Arthroplasty, Replacement, Hip, Hip Replacement, Total

Intervention / Treatment
-----------------
* Procedure: Pillow


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient awaiting primary total hip arthroplasty using a posterior approach in a lateral decubitus position Patients capable of reading, understanding, and willing to sign the informed consent form Exclusion Criteria: Total hip arthroplasty not using a posterior approach in a lateral decubitus position Prior hip osteotomy or fracture osteosynthesis on the index hip

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pillow Group<br>There will be a pillow placed between the patients legs during their operation. | Procedure: Pillow<br>* A pillow to lessen the angle differences between hips so that the acetabular component can be placed in an optimal position.<br>|
| No Intervention: Control Group<br>They will receive a normal total hip arthroplasty. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in radiographic cup inclination angle | The difference between the operative and postoperative radiographic cup inclination angle | Intra-operatively and post-operatively (within one month after the surgery) |
Evaluation of Survival in Patients With Metastatic Breast Cancer Receiving High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to evaluate the outcome of patients affected with different subtypes of metastatic breast cancer following treatment with high-dose chemotherapy and autologous haematopoietic progenitor cell transplantation.

Conditions
-----------------
Breast Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 years Metastatic breast Cancer Treatment with high-dose chemotherapy and autologous haematopoietic progenitor cell transplantation between 2003 and 2012 Exclusion Criteria: Lack of follow-up data

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Overall Survival according to Immunohistochemical subtypes . |  | 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free Survival according to Immunohistochemical subtypes . |  | 8 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic breast cancer, high-dose chemotherapy, autologous haematopoietic progenitor cell transplantation
Estrogen Receptor Gene Mutations

Study Overview
=================
Brief Summary
-----------------
We propose to analyze a DNA sample for mutations in the estrogen receptor gene from a patient who appears insensitive to estrogen hormone treatment.

Detailed Description
-----------------
We propose to analyze a DNA sample for mutations in the estrogen receptor gene from a patient who appears insensitive to estrogen hormone treatment.

Official Title
-----------------
Estrogen Receptor Gene Mutations

Conditions
-----------------
Mutations, Hormones

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Patient is individual with estrogen insensitivity.

Ages Eligible for Study
-----------------
Minimum Age: 18 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
-----------------
DNA, Hormone, Resistance, Skeleton
Treatment of Epidemic Keratoconjunctivitis With 2% Povidone-iodine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the outcomes of treating epidemic keratoconjunctivitis with 2% povidone-iodine.

Detailed Description
-----------------
The study design was a prospective interventional case series. Our institutional ethical committee approved the study protocol in April 2004. We performed this study between July 2004 and December 2009. During this period, there were 2 episodes of EKC epidemic. The first episode was in 2006 and the second in 2009.

Official Title
-----------------
Treatment of Epidemic Keratoconjunctivitis With 2% Povidone-iodine

Conditions
-----------------
Viral Conjunctivitis

Intervention / Treatment
-----------------
* Drug: 2% povidone-iodine
* Drug: 2% povidone-iodine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who were diagnosed with EKC at the outpatient ophthalmic unit Exclusion Criteria: children younger than six years women being pregnant or during lactation history of allergy to povidone-iodine prior ocular surgery contact lens usage and chronic eye diseases with current eye medications.

Ages Eligible for Study
-----------------
Minimum Age: 7 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2% povidone-iodine<br> | Drug: 2% povidone-iodine<br>* apply 4 times a day for one week<br>* Other names: PVP-I;Drug: 2% povidone-iodine<br>* apply 2% povidone-iodine 4 times per day for one week<br>* Other names: PVP-I;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the recovery rate within one week of treatment |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| drug tolerability | proportion of patient who can continue topical application of povidone-iodine for a week or until EKC subsides | 1 week |
Transanal Tube Drainage in Endoscopic Submucosal Dissection of the Colorectal Tumor

Study Overview
=================
Brief Summary
-----------------
We design the clincal trial to investigate the efficacy of transanal tube drainage in colorectal ESD.

Detailed Description
-----------------
Endoscopic submucosal dissection (ESD) is a technique for endoscopic tissue resection that enables endoscopists to control the depth and direction of diathermic knife incisions.Recently, the number of reports in which ESD has been successfully used to treat colorectal tumors has increased. But the complatios with colorectal ESD were higher than esophagus and stomach ESD.We design the clincal trial to investigate the efficacy of transanal tube drainage in colorectal ESD.

Official Title
-----------------
Transanal Tube Drainage in Endoscopic Submucosal Dissection of the Colorectal Tumor: A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group, Superiority Clinical Trial

Conditions
-----------------
Colorectal Tumor

Intervention / Treatment
-----------------
* Device: Transanal Tube Drainage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Endoscopy proven colorectal polyp>2cm, LST>3cm, SMTs<2cm Suitable for ESD No other organic disease of colorectal Removing a single lesion one time Informed consent Exclusion Criteria: Complicated other colorectal diseases, such as,Crohn's disease Familial adenomatous polyposis With previous colorectal surgery Pregnancy or lactation Absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class > III) ESD conversion to laparotomy Patients cannot receive ESD Patients and/or family members can not understand and accept this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transanal Tube Drainage<br>patients with transanal tube drainage after ESD | Device: Transanal Tube Drainage<br>* Using transanal tube drainage after colorectal ESD<br>|
| No Intervention: Without Transanal Tube Drainage<br>patients without transanal tube drainage after ESD | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications | bleeding, perforation,coagulation syndrome | 30 days post operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ESD;Transanal Tube Drainage;Colorectal Tumor
Treatment Effects of Atorvastatin on Hemostasis and Skin Microcirculation in Patients With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
Patients with type 1 diabetes are at increased risk of vascular complications both in the micro- and macrocirculation. Hyperglycemia plays a major role in the development of these vascular complications, but other factors such increased platelet adhesion and aggregation, elevated levels of plasma fibrinogen, altered fibrin network structure, increased thrombin generation, dyslipidemia and endothelial dysfunction may contribute. Lipid-lowering therapy with statins is effective in prevention of cardiovascular events in individuals at increased risk. Statins seem to exert beneficial effects on hemostasis and vasculature that are independent of their lipid-lowering properties. The aim of the present study was to investigated the effects of intensive LDL-cholesterol-lowering therapy with atorvastatin on fibrin network permeability (primary variable) and other aspects of hemostasis in patients with type 1 diabetes and dyslipidemia. Furthermore, the effects of atorvastatin therapy on skin microvascular function was also investigated.

Conditions
-----------------
Type 1 Diabetes Mellitus, Dyslipidemia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 1 diabetes level of plasma LDL-cholesterol >2.5mmol/L and/or total cholesterol >4.5mmol/L Exclusion Criteria: History of macrovascular events

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atorvastatin<br>Atorvastatin 80mg once daily | Drug: Atorvastatin<br>* Atorvastatin 80mg once daily for 8 weeks<br>|
| Placebo Comparator: Placebo<br>Matched placebo tablets | Drug: Placebo<br>* Placebo tablet once daily for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibrin network permeability |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| platelet and endothelial microparticles |  | 8 weeks | 
| skin microvascular reactivity |  | 8 weeks |
Study In Adults And Adolescents With Seasonal Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as hay fever, it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 14 Days in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis

Conditions
-----------------
Seasonal Allergic Rhinitis, Hayfever, Rhinitis, Allergic, Seasonal

Intervention / Treatment
-----------------
* Drug: fluticasone furoate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Informed consent. Outpatient. Females must use appropriate contraception. Diagnosis of seasonal allergic rhinitis. Adequate exposure to allergen. Able to comply with study procedures. Literate. Exclusion criteria: Significant concomitant medical condition. Use of corticosteroids, allergy medications, or tobacco. Clinically significant abnormal ECG. Laboratory abnormality. Positive pregnancy test. Allergy to any component of the investigational product.

Ages Eligible for Study
-----------------
Minimum Age: 12 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: fluticasone furoate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline over the entire treatment period in daily, reflective, total nasal symptom scores. |  |  | 
| Mean change from baseline over the entire treatment period in the daily, reflective, total ocular symptom score. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous, total nasal symptom score. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GW685698X, once daily, mountain cedar, allergic rhinitis, fluticasone furoate
Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single administration of KHK7580 for secondary hyperparathyroidism in patients receiving peritoneal dialysis.

Official Title
-----------------
A Single-dose Phase 1 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis

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

Intervention / Treatment
-----------------
* Drug: KHK7580


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Stable chronic renal disease patients receiving peritoneal dialysis for at least 16 weeks prior to the screening intact parathyroid hormone value ≥ 240 pg/mL at the screening Corrected serum calcium ≥ 8.4 mg/dL at the screening Exclusion Criteria: Patients with primary hyperparathyroidism Patients who received cinacalcet within 2 weeks prior to the screening Patients who began to take or changed the dose/dosing regimen of active vitamin D/its analogs, phosphate binders and/or calcium containing compounds within 2 weeks prior to the screening Patients who underwent parathyroidectomy and/or parathyroid intervention Patients with uncontrolled hypertension and/or diabetes Patients with severe heart disorder Patients with severe hepatic disease Patients who take investigational drug in another clinical trial within 12 weeks prior to the screening Patients who have been judged ineligible to participate in the study by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KHK7580<br> | Drug: KHK7580<br>* Oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and types of adverse events | The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs and electrocardiogram | For 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profiles of pharmacokinetics | intact parathyroid hormone, whole parathyroid hormone, corrected serum calcium, phosphorus, intact fibroblast growth factor 23, ionized calcium, calcitonin | Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 and 168 hours post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis