linjc16/ctgov huggingface dataset:
Using 3.3mm Screw Tap and Cutting Resistance to Evaluate Bone Quality Around Dental Implant

Study Overview
=================
Brief Summary
-----------------
Osseointegrated root form implants have been applied successfully in treating fully and partially edentulous patients and patients with single tooth missing. However, the success rate of osseointegrated dental implants was not as good in patients with poor bone quality. The reasons are believed that poor bone quality reduces the initial stability of dental implants and then reduces the success rate. For increasing initial stability of dental implants, some technical modifications are suggested in literature. However, due to lack of an objective method to evaluate bone quality, they are controversial. The purposes of this clinical study are to develop a standard procedure which using cutting resistance measured by Osseocare in surgery to evaluate the bone quality and to compare with the clinical experiences of oral surgeons. The objective outcome, initial stability of dental implant, is measured with Osstell. The analyzed results are also helpful for less experienced surgeons.

Detailed Description
-----------------
Materials & Methods: 1. Patient eligibility: Six implant surgeons will assist the experiment. The subjects are patient who will receive dental implant treatment in Dental department of NTUH. Sixty subjects are offered by six surgeons. They must fully fill the requirements as following

Official Title
-----------------
Using 3.3mm Screw Tap to Modify the Standard Implantation Procedure and to Measure the Cutting Resistance for Establishing a More Objective Method to Evaluate the Peri-Implant Bone Quality

Conditions
-----------------
Jaw, Edentulous, Partially, Mouth, Edentulous

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No major systemic diseases Mouth opening: > 35 mm Missing teeth at anterior or premolar area and willing to restored by implantation Exclusion Criteria: Uncomfortable or other condition occurring in the surgical procedure make the measuring unacceptable

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Observatoire Des Patients Atteints de Laminopathies et Emerinopathies (Observatory for PAtients With Laminopathies and Emerinopathies)

Study Overview
=================
Brief Summary
-----------------
Laminopathies and emerinopathies are complex group of rare disorders due to mutations in A-type lamins (LMNA) and Emerin (EMD) genes. Among them, disorders affecting skeletal and/or cardiac muscles are the most frequent clinical manifestations, with cardiac disease being a major cause of death. Remarkable progress has been made in the description of the clinical and genetic spectrum of these diseases since the 1990's. Until now, precise phenotype/genotype relations remain elusive. As for several other neuromuscular disorders, apart from symptomatic treatments, there is currently no specific treatment to prevent or slow down the progression of the disease. The OPALE registry is a multicentre web-based registry dedicated to laminopathy and emerinopathy French patients. OPALE has been approved by ethical and regulatory authorities. Its main inclusion criteria is the presence of a proven pathogenic LMNA and/or EMD gene mutation. The OPALE objectives are to provide a tool allowing detailed capture of patient genetic, neurological, cardiological, endocrinological and respiratory assessments, in order to allow i) precise disease natural history, ii) evaluation of different disease complication frequency and iii) identification of prognosis factors.

Official Title
-----------------
Observatoire Des Patients Atteints de Laminopathies et Emerinopathies (Observatory for PAtients With Laminopathies and Emerinopathies)

Conditions
-----------------
Laminopathies, Emerinopathies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of a proven pathogenic LMNA and/or EMD gene mutation Regular followup in France. Signed informed consent Exclusion Criteria: -Signed informed refusal
Sexes Eligible for Study
-----------------
All

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehensive clinical evaluation of individuals with geneticaly proven mutations in LMNA or EMD genes according to the study protocol, in order to evaluate disease progression | Comprehensive clinical evaluation of individuals with geneticaly proven mutations in LMNA or EMD genes according to the study protocol, in order to evaluate disease progression | yearly up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lamin A/C, Emerin
Efficacy of FLAG Regimen for the Treatment of Patients With AML

Study Overview
=================
Brief Summary
-----------------
The long-term efficacy of chemotherapy in patients with acute myeloid leukemia (AML) has been significantly improved in recent years. The combination of anthracycline plus cytarabine (Ara-C) has been a standard induction regimen for patients with AML. However, the optimal consolidation therapy after induction chemotherapy has not reached a consensus. The FLAG regimen consisting of fludarabine and high-dose cytarabine combined with G-CSF which is one of the first-line consolidation treatment options for relapsed and refractory AML. This study conducted a retrospective analysis of the intensive treatment of AML with the FLAG regimen from January 2007 to May 2018 in our hospital to evaluate the efficacy of the FLAG regimen. To provide the basis for the choice and timing of treatment for patients with AML treated with the FLAG regimen.

Official Title
-----------------
Efficacy of Fludarabine, Cytarabine and G-CSF (FLAG Regimen) for the Treatment of Patients With Acute Myeloid Leukemia (AML)

Conditions
-----------------
Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient more than 18 year old De novo or secondary leukemia. Treated with FLAG regimen Exclusion Criteria: Acute promyelocytic leukemia (APL)

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 |
| --- | --- | --- |
| Overall survival | For evaluating the FLAG effect, OS was defined from consolidation randomization to death from any cause (censored at last contact). | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free survival | Relapse Free Survival defined as the time from onset of FLAG treatment for AML to the first event (death or relapse). | 2 years | 
| Severe adverse events | Severe adverse events during consolidation treatment | 45 days | 
| Complete Remission Rate |  | 2 months | 
| Event-Free Survival Rate |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FLAG
Injury Epidemiology Within Scottish Professional Football

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to establish the injury incidence, severity and burden typically observed within Scottish professional football clubs. In line with the well-established model of sports injury prevention research proffered by van Mechelen, the first stage in this process is establishing the extent of the problem i.e. injury incidence, severity and burden. Such a multi-club study has never been conducted within Scotland despite a thriving professional game.

Official Title
-----------------
Scottish Football Injury Study (S-FIS): Epidemiology of Injuries in Scottish Professional Football - A Multi-club, One Season Study

Conditions
-----------------
Injury;Sports

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Professional football player contracted to an SPFL club Exclusion Criteria: Loss of professional status as a footballer
Sexes Eligible for Study
-----------------
Male

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injury incidence | The number of injuries per 1000 hours of exposure | 1 year | 
| Injury type | The types of injuries observed e.g. contact/non-contact, anatomical location, soft-tissue/hard-tissue | 1 year | 
| Injury burden | The number of days lost due to injury per 1000 hours of exposure | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Association football, Soccer, Injury, Epidemiology
Reduced Dose of Prophylactic Dexamethasone for Elderly Patients Receiving Moderate Emetogenic Chemotherapy

Study Overview
=================
Brief Summary
-----------------
Feasibility study to evaluate the efficacy of reduced prophylactic dose of dexamethasone in elderly patients receiving moderate emetogenic chemotherapy

Detailed Description
-----------------
The purpose of this trial is to determine if the dose of dexamethasone used as an antiemetic drug in patients with advanced cancer could be safely reduced.

Official Title
-----------------
A Feasibility Study of Reduced Dose of Prophylactic Dexamethasone for Elderly Patients Receiving Moderate Emetogenic Chemotherapies

Conditions
-----------------
Colonic Neoplasms

Intervention / Treatment
-----------------
* Drug: Dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histopathologically confirmed colorectal cancer patients with curative resection ECOG performance status 0-2 Provision of signed, written and dated informed consent prior to any study specific procedures Receiving adjuvant chemotherapy with FOLFOX (5-FU, leucovorin, oxaliplatin) regimen Exclusion Criteria: Having contraindication to dexamethasone Having nausea or vomiting before the start of adjuvant chemotherapy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elderly patients (>= 70 years of age)<br>Dexamethasone 8mg intravenously before chemotherapy | Drug: Dexamethasone<br>* Dexamethasone 8mg IV before chemotherapy on cycle 1 day 1 Once the complete response is achieved, the dose of dexamethasone will be reduced by 2 mg in the next cycle.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response (CR) | No emetic episode, no rescue medicine | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete control (CC) | complete response with no more than mild nausea | 2 weeks | 
| Complete protection (CP) | complete response with no nausea | 2 weeks |
A Comparison of LMA-Supreme and I-gel for the Incidence of Postoperative Sore Throat

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate and compare the incidence of the postoperative sore throat between LMA supreme and I-gel.

Conditions
-----------------
General Anesthesia

Intervention / Treatment
-----------------
* Device: LMA supreme
* Device: I-gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - adult patients aged over 19 years who are scheduled for elective surgery under general anesthesia using the laryngeal mask airway Exclusion Criteria: Anticipated difficult airway Expected duration of surgery more than 4 hours body mass index more than 35 kg/m2 pregnancy Upper gastrointestinal surgery or open abdominal surgery.

Ages Eligible for Study
-----------------
Minimum Age: 19 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LMA supreme<br>Anesthesia is maintained using LMA supreme during surgery. | Device: LMA supreme<br>* Anesthesia is maintained using LMA supreme in LMA supreme group or using I-gel in I-gel group according to the randomly allocated groups.<br>|
| Active Comparator: I-gel<br>Anesthesia is maintained using I-gel during surgery. | Device: I-gel<br>* Anesthesia is maintained using LMA supreme in LMA supreme group or using I-gel in I-gel group according to the randomly allocated groups.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative sore throat | The postoperative sore throat will be evaluated after the end of surgery by the investigator who are blinded to the group assignments. The investigator will ask the participant about his/her sore throat status. | within 24 hours after the end of surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative dysphagia | The postoperative dysphagia will be evaluated after the end of surgery by the investigator who are blinded to the group assignments. The investigator will ask the participant about his/her status. | within 24 hours after the end of surgery | 
| Postoperative dysphonia | The postoperative dysphonia will be evaluated after the end of surgery by the investigator who are blinded to the group assignments. The investigator will ask the participant about his/her status. | within 24 hours after the end of surgery |
Aspirin, Heparin and Miscarriage

Study Overview
=================
Brief Summary
-----------------
Efficacy of low dose aspirin (LDA) versus LDA plus low-molecular-weight-heparin (LMWH) in patients with a history of recurrent miscarriages.

Official Title
-----------------
Low Dose Aspirin and Low-molecular-weight Heparin in the Treatment of Pregnant Libyan Women With Recurrent Miscarriage

Conditions
-----------------
Pregnancy, Miscarriage

Intervention / Treatment
-----------------
* Drug: Aspirin
* Drug: Heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women History of 2 or more of miscarriage Exclusion Criteria: Twins

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 48 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aspirin<br>75mg tab of aspirin once daily | Drug: Aspirin<br>* 75mg tab of LDA once daily for 7 months<br>* Other names: LDA;|
| Active Comparator: Aspirin + heparin<br>75mg tab of aspirin once daily + 0.4 mL/day of injection of low molecular weight heparin | Drug: Aspirin<br>* 75mg tab of LDA once daily for 7 months<br>* Other names: LDA;Drug: Heparin<br>* 0.4 mL/day of the Enoxaparin<br>* Other names: Enoxaparin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of miscarriages | To compare number of miscarriages between the two groups | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aspirin, Heparin, pregnancy, miscarriage
Effectiveness of Nefopam for Thermoregulation During Surgery

Study Overview
=================
Brief Summary
-----------------
Nefopam may help blunt thermoregulatory defenses, thus facilitating induction of therapeutic hypothermia

Detailed Description
-----------------
Hypothermia, whether therapeutically induced or unintentional, triggers thermoregulatory defenses including vasoconstriction and shivering. Nefopam, a non-opioid, nonsteroidal centrally acting analgesic, has an opioid-sparing effect and anti-shivering potency without sedation, making it an ideal candidate to counteract thermoregulatory shivering. Since complete compartmental pharmacokinetics (PK) are lacking this prospective, randomized, double-blind study in 8 volunteers was set to investigate the PK of arterial nefopam samples with non-linear mixed effect modelling. A two compartment mammillary model independent of covariates was found to describe the data best and could be implemented to drive automated pumps, achieving and maintaining a desired plasma concentration.

Official Title
-----------------
Effectiveness of Nefopam for Thermoregulation During Surgery

Conditions
-----------------
Hypothermia

Intervention / Treatment
-----------------
* Drug: Nefopam Low dose
* Drug: Nefopam High dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal healthy volunteers ages 18-40 Exclusion Criteria: history of alcohol or drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Volunteers given two doses of nefopam in a crossover protocol.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nefopam low dose<br>Nefopam continuous intravenous infusion at 0.5 mg/ml for three hours. | Drug: Nefopam Low dose<br>* Continuous intravenous infusion at 0.5 mg/ml for three hours.<br>* Other names: Low;|
| Active Comparator: Nefopam high dose<br>Nefopam continuous intravenous infusion at 1.0 mg/ml for three hours. | Drug: Nefopam High dose<br>* Continuous intravenous infusion at 1.0 mg/ml for three hours.<br>* Other names: High;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| V1 | Volume of distribution 1 | three hours of infusion | 
| V2 | Volume of distribution2 | three hours of infusion | 
| CLel | Clearance | three hours of infusion | 
| CLdist | Clearance distribution | three hours of infusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nefopam, Pharmacokinetics, Shivering,, Thermoregulation, Anesthesia
Assessment of Quality of Life of Children With Chronic Idiopathic Thrombocytopenic Purpura (Kid's ITP Tools)

Study Overview
=================
Brief Summary
-----------------
Assessment of quality of life of patient with chronic idiopathic thrombocytopenic purpura according to the type of treatment

Official Title
-----------------
Assessment of Quality of Life of Children With Chronic Idiopathic Thrombocytopenic Purpura

Conditions
-----------------
Idiopathic Thrombocytopenic Purpura

Intervention / Treatment
-----------------
* Other: completion of questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with Idiopathic thrombocytopenic purpura aged between 1 and 17 year Idiopathic thrombocytopenic purpura persistent at 12 months obtention of informed consent Exclusion Criteria: Persistant/acute Idiopathic thrombocytopenic purpura concomittant chronic disease, stabilized or not Concomittant disease with life expectancy < 1 year Person who have not belong to a social security scheme Secondary Idiopathic thrombocytopenic purpura

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 17 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 |
| --- | --- |
| Idiopathic Thrombocytopenic Purpura<br>completion of questionnaire | Other: completion of questionnaire<br>* completion of questionnaire for patient and parent<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life score according to type of treatment | quality of life score according to type of treatment | at inclusion visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of hospitalisation and consults per year | number of hospitalisation and consults per year | at inclusion visit | 
| description of general quality of life | use ped'sQL general | at inclusion visit | 
| description of general quality of life | use ped'sQL fatigue | at inclusion visit | 
| description of awareness of parent and patient about Idiopathic thrombocytopenic purpura | use Kid's ITO Tools questionnaire | at inclusion visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Idiopathic Thrombocytopenic Purpura