linjc16/ctgov huggingface dataset:
Application and Revision of Montreal Cognitive Assessment in Chinese Retirees

Study Overview
=================
Brief Summary
-----------------
The study was designed to employ MOCA to screen mild cognitive impairment (MCI) in military retirees and to analyze the associated risk factors. As such, MOCA was revised to be validated for the Chinese context.

Detailed Description
-----------------
Three hundred and four retired military cadres were investigated using a random cluster sampling technique including personal information, prevalence, MOCA scale, and related neuropsychiatry scale. Thirty retirees were random chosen and tested again with the revised MOCA scale one month later.

Official Title
-----------------
Application and Revision of Montreal Cognitive Assessment in Military Retirees With Mild Cognitive Impairment

Conditions
-----------------
Mild Cognitive Impairment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged >=60 years old retired military cadres lived in Xian,Shaanxi,China questionnaires completed Exclusion Criteria: deaf-mute

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| original MOCA<br>The Chinese retired military cadres were surveyed with the revised MOCA scale. | |
| revised MOCA<br>The random part of participants were surveyed with the revised MOCA scale. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MCI occurrence rate | Three hundred and four retired military cadres from 9 Xi'an military sanatoria were investigated，assessed up to 8 months | up to 8 months |
Transpulmonary Pressure Under Stressing Conditions

Study Overview
=================
Brief Summary
-----------------
Study aims to prospectively evaluate if the pressures normally applied during mechanical ventilation in laparoscopic surgery induce stress on the pulmonary wall. To do this is used measure the variation of esophageal pressure, as indirect index of the pleural pressure and therefore of the transpulmonary pressure, in response to changes in airway pressures in a group of patients undergoing robotic assisted radical prostatectomy or videolaparoscopy.

Official Title
-----------------
Transpulmonary Pressure Under Conditions of Increased Intra-abdominal Pressure From Pneumoperitoneum and Steep Trendelenburg

Conditions
-----------------
Ventilator-Induced Lung Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA (american society of anesthesiologists) score ≤ III Patients underwent laparoscopic prostatectomy Exclusion Criteria: BMI (body mass index) ≥ 30 Impossibility to insert nasogastric tube Anatomic rib cage alterations

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Incidence of postoperative acute complications | Evaluation of pulmonary alterations using pre and postoperative ultrasonographic visualization | 24 hours | 
| Dosage of inflammatory mediators | Dosage of metalloproteinase and interleukin 8 in bronchoaspiration | 24 hours |
Phase 3 Study of Pelubiprofen & Loxoprofen in Patients With Upper Respiratory Tract Infection

Study Overview
=================
Brief Summary
-----------------
Multi-center, Randomized, Double blind, Controlled Parallel-group Comparative Phase 3 Clinical trial to assess the efficacy and safety of Pelubiprofen Compared to Loxoprofen in patients with Acute upper respiratory infection.

Conditions
-----------------
Acute Upper Respiratory Infection, Fever

Intervention / Treatment
-----------------
* Drug: Pelubiprofen
* Drug: Loxoprofen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 15 years old Male and Female Patients with fever over 38.0°C due to cold (acute upper respiratory tract infection) Patients with upper respiratory tract infection outbreak within 2 days and who did not received drug administration Subjects who voluntarily or legal guardian agreed with written consent Exclusion Criteria: Fever reducer administration Within 4 hours from the screening point Any incidence of febrile crisis from the past six months Patients with Ulcers, gastrointestinal disorders which are confirmed by endoscopy Patients with continuously administrating gastrointestinal disorder related drug Patients with severe blood damage Severe hepatic impairment (ALT, AST value more than 2 times the upper limit of the normal range) With severe renal impairment (serum creatinine value is more than 2 times the upper limit of the normal range) Patients with severe left ventricular dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 15 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: Pelubiprofen<br> | Drug: Pelubiprofen<br> <br> * Other names: Pelubiprofen 30 mg;|
| Active Comparator: Loxoprofen<br> | Drug: Loxoprofen<br> <br> * Other names: Loxoprofen 60mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Body temperature from baseline |  | 0, 0.5, 1, 1.5, 2, 3, 4, 6 Hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pelubi, Pelubiprofen, Loxoprofen, Anti-pyretic, Fever
The Diagnostic Technology Applied Research of CDK5RAP2 in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Selected 400 cases of women with primary breast cancer who were treated with operation randomly, then detect the expression of CDK5RAP2 of cancer tissue. At the same time randomly selected 100 women with primary breast cancer who were under neoadjuvant chemotherapy. Detect the expression of CDK5RAP2 before and after neoadjuvant chemotherapy.

Detailed Description
-----------------
The investigators selected 400 cases of women with primary breast cancer who were treated with operation randomly,then detect the expression of CDK5RAP2 of cancer tissue. At the same time randomly selected 100 women with primary breast cancer who were under neoadjuvant chemotherapy. Detect the expression of CDK5RAP2 before and after neoadjuvant chemotherapy.

Official Title
-----------------
The Diagnostic Technology Applied Research of CDK5RAP2 in Breast Cancer

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent Pathological confirmation of breast cancer Tumor stage(TNM):T2-4bN0-3M0 ER(+) and/or PR(+). Premenopausal woman. Age≥40 years Measurable disease as per RECIST criteria Karnofsky≥70 Laboratory criteria: PLT≥100*109/L WBC≥4000/mm3 HGB≥10g/dl ALT and AST<2*ULN Exclusion Criteria: Presence of metastatic disease. Inflammatory breast cancer. Bilateral breast cancer. previous chemotherapy or hormonal therapy for current breast neoplasm. other malignant tumor (concurrent or previous). Pregnant woman. Hypersensitive to any drug in CEF regimen or any ingredient of Zoladex. Any severe systemic disease contraindicating chemotherapy.
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
-----------------
expression of CDK5RAP2
Flapless Zygomatic Implants Robot-assisted Placement

Study Overview
=================
Brief Summary
-----------------
Zygomatic implants are indicated for the rehabilitation of the severely atrophic maxilla. Similar to standard implant placement, gaining an optimal position of the zygomatic implants is essential for a predictable prosthetic-driven treatment outcome. However, there is no effective mechanism to physically control the drilling trajectory for the zygomatic implants. Therefore, deviation between the actual and planned implant position is inevitable. This approach is technically difficult, and is performed by an experienced surgeon. The development of a surgical technique that is both safer and less invasive is currently possible thanks to robotics. In this project, a robotic assisted new strategy for positioning zygomatic implants will be performed and its efficacy and accuracy will be assess. Path planning will be carried out on a pre-operative scanner. The ROSA robot (Zimmer®) will guide the several drillings steps. Placement of the zygomatic implant will be performed manually.

Official Title
-----------------
Flapless Zygomatic Implants Robot-assisted Placement

Conditions
-----------------
Zygomatic Implant, Robotic

Intervention / Treatment
-----------------
* Procedure: Zygomatic implants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from Maxillary edentulism with severe bone resorption Patients suffering from maxillary edentulism post maxillary defect (carcinologic or traumatic) and free flap reconstruction Patients suffering from post-maxillectomy buccosinusal communication. Age ≥ 18 years old Having signed the informed consent Exclusion Criteria: Patients suffering from chronic sinusitis Patients refusing ROSA robot-guided surgery (unsigned informed consent). Pregnant and nursing women

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Zygomatic implants|A robotic assisted new strategy for positioning zygomatic implants will be performed and its efficacy and accuracy will be assess|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation rate between theoretical intraoperative position and post-operative zygomatic implants position | The accuracy of zygomatic implants positioning will be evaluated by comparing the theoretical intraoperative position and the actual post-operative position by image fusion. | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
zygomatic implant, robotic, flapless, mini-invasive, ROSA, immediate loading
Intravesical Injection of Botox for Treating Therapy Refractory Overactive Bladder in Females

Study Overview
=================
Brief Summary
-----------------
The neurotoxin Botox (botulinum neurotoxin type A) is shown to be effective in the treatment of therapy refractory overactive bladder syndrome. Our data suggests a longer during efficacy than known from the use in striated muscle. The aim of our study is to analyze short- and longterm efficacy after Botox treatment and to evaluate risk factors for non-responders and side effects such as urinary retention.

Official Title
-----------------
Short- and Longterm Results After Intravesical Injection of Botulinum Neurotoxin Type A for Treating Therapy Refractory Overactive Bladder in Females - a Retrospective Study

Conditions
-----------------
Overactive Bladder Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intravesical treatment with Botox at our clinic

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Botox<br>patients who received intravesical injections of botulinum neurotoxin type A | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of effect of Botox |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
botulinum neurotoxin type A, BoNT/A, Botox, overactive bladder syndrome
Comparison of Anwar and Melles Techniques in Deep Anterior Lamellar Keratoplasty (DALK) for Keratoconus Patients

Study Overview
=================
Brief Summary
-----------------
This study will be performed on patients who come to labbafinejad ophthalmic clinic from 20 March 2008. Keratoconus diagnosis will be determined by clinical finding in slit lamp, keratometery and topographic characteristics. Patients will be randomly placed in group A and B. In group A, Anwar surgical method and in B, Melles surgical method, will be done. This is not a blind study due to surgeons' knowledge. All patients will receive Btamethazone drop and Chloramphenicol every 6 hours and will be tapered in two months. In the end anatomical results, complications, BCVA, UCVA, astigmatism, endothelial cell numbers will be compared in two groups by using specular microscopy. Contrast sensivity, central corneal diameter, interface wrinkling and opacity will be measured by metrovison, Confoscan, Photoslit in months 3, 6, 12, respectively and will be evaluated afterwards.

Conditions
-----------------
Keratoconus

Intervention / Treatment
-----------------
* Procedure: Anwar
* Procedure: Melles


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with keratoconus 15<age<45 contact lens intolerance Exclusion Criteria: Having a history of any other ophthalmic or systemic problem Central corneal scar descemet's membrane detachment

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 45 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 |
| --- | --- |
| Experimental: Melles<br> | Procedure: Melles<br>* Melles surgical method<br>|
| Experimental: Anwar<br> | Procedure: Anwar<br>* Anwar surgical method<br>|

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
-----------------
Anwar, Melles, Keratoconus
Osteofibrous Dysplasia (Kempson-Campanacci's Disease)

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to obtain long term follow-up in patients with osteofibrous dysplasia, to assess natural history of the disease, late results of treatment and in particular the potential and risk of progression to adamantinoma.

Official Title
-----------------
Osteofibrous Dysplasia (Kempson-Campanacci's Disease): Long Term Follow-up Study on Natural History, Results of Treatment and Relationship With Adamantinoma

Conditions
-----------------
Osteofibrous Dysplasia

Intervention / Treatment
-----------------
* Behavioral: study of osteofibrous dysplasia features


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients treated at Rizzoli Institute from 01 Jan 1943 to 31 Dic 2011 Diagnosis of osteofibrous dysplasia pathologically confirmed Written informed consent prior to any study-specific analysis and/or data collection Exclusion Criteria: Patients with histological diagnosis different from osteofibrous dysplasia
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: study of osteofibrous dysplasia features|obtain long term follow-up in patients with osteofibrous dysplasia, to assess natural history of the disease, late results of treatment and in particular the potential and risk of progression to adamantinoma.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osteofibrous Dysplasia (Kempson-Campanacci's disease): Long Term Follow-up Study on Natural History, Results of Treatment and Relationship with Adamantinoma | We will retrieve from the database of the Rizzoli institute all the cases with a histological diagnosis of Ewing sarcoma from 01 Jan 1943 to 31 Dic 2011. We aspect to find approximately 55 cases. We will review all the medical records, radiological imaging, and histological data of these cases. | BASELINE |
Patient Specific Induced Pluripotency Stem Cells (PSiPS)

Study Overview
=================
Brief Summary
-----------------
Induced pluripotent stem cells (iPSCs) are adult cells that have been genetically reprogrammed to an embryonic stem cell-like state by being forced to express genes and factors important for maintaining the defining properties of embryonic stem cells. The reprogramming of adult cells into embryonic stem (ES) cells enables the generation of patient-specific stem cells and thus has enormous potential for the treatment and analysis of degenerative diseases. In this project the investigators are going to induce pluripotent stem cells from cell cultures from skin biopsies of patients. The iPS cells will be developed for modeling diseases and drug discovery as well as basic research.

Detailed Description
-----------------
iPS cells are typically derived by transfection of certain stem cell-associated genes into non-pluripotent cells, such as adult fibroblasts. Transfection is typically achieved through viral vectors, such as retroviruses. Transfected genes include the master transcriptional regulators Oct-3/4 (Pouf51) and Sox2, although to enhance the efficiency of induction some other genes e.g. Klf4, c-Myc. In this study after separation the fibroblasts from patient's skin biopsy, the cells are transfected with 4 Yamanaka factors (human Oct4, Sox2, Klf4, c-Myc) after 3-4 weeks, transfected cells are isolated through morphological selection.

Official Title
-----------------
Patient Specific Induced Pluripotency Stem Cells (PSiPS)

Conditions
-----------------
Hepatic Disorders, Eye Disorders

Intervention / Treatment
-----------------
* Procedure: Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Donors suffering from different (specified) metabolic disorders Donors suffering from different (specified) eye disorders which resulted to blindness Special blood group: O Bombay Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Biopsy|Skin biopsy|

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
-----------------
Induced pluripotent stem cells, Hepatic disorders, Eye disorders, Blood groups
A Drug Utilization Study of Radium-223 in Sweden

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the extent of potential off-label use of Xofigo in Sweden.

Official Title
-----------------
A Drug Utilization Study of Xofigo Use in Sweden

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

Intervention / Treatment
-----------------
* Other: Radium-223 dichloride (Xofigo, BAY88-8223)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving Xofigo with data recorded at nuclear medicine centers in Sweden between 01 July 2014 and 30 June 2016 will be included in the study Exclusion Criteria: Patients receiving Xofigo in a clinical trial will not be included in this study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group1<br>This is a single-arm descriptive observational drug utilization study based on secondary data collection of patients treated with Xofigo in Sweden. This study will include patients receiving treatment of Xofigo at certified nuclear medicine centers across Sweden during a two year period. | Other: Radium-223 dichloride (Xofigo, BAY88-8223)<br>* Xofigo was approved in the US and EU for the following indication: Xofigo is indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. Xofigo is contraindicated in women who are or may become pregnant.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of men with metastatic castration resistant prostate cancer (mCRPC) of Xofigo use |  | Up to 2 years | 
| Proportion of being women of Xofigo use |  | Up to 2 years | 
| Proportion of being children of Xofigo use |  | Up to 2 years | 
| Proportion of bone metastasis but having a diagnosis of other cancer than mCRPV |  | Up to 2 years | 
| Dosage of Xofigo (kBq/kg) |  | Up to 2 years | 
| Proportion of participants of dose outside label recommendation |  | Up to 2 years |