linjc16/ctgov huggingface dataset:
The Recovery Time of Quadriceps Strength After Total Knee Arthroplasty (TKA): The Effect of Quadriceps Incision Length

Study Overview
=================
Brief Summary
-----------------
Minimally invasive total knee arthroplasty (MIS-TKA) became the popular technique. It had the less postoperative pain and shorter recovery time compared to the conventional technique. With using MIS technique, less cut of quadriceps tendon was the key. It related to keep more quadriceps strength and improve functional performance after TKA. However, there was no previous studies about the effect of quadriceps incision length in the recovery time of the quadriceps strength. The investigators hypothesized that longer quadriceps incision affected the longer recovery time of quadriceps strength in MIS-TKA.

Official Title
-----------------
The Recovery Time of Quadriceps Strength After Total Knee Arthroplasty: The Effect of Quadriceps Incision Length

Conditions
-----------------
Osteoarthritis of Knee

Intervention / Treatment
-----------------
* Procedure: Quadriceps incision < 2 cm
* Procedure: Quadriceps incision 2-4 cm
* Procedure: Quadriceps incision > 4 cm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who diagnosed primary osteoarthritis of knee with varus or valgus deformity < 20 degrees preoperative range of motion > 90 degrees extension lag < 10 degrees Flexion contracture < 30 degrees Exclusion Criteria: Bilateral simultaneous total knee arthroplasty Previous knee surgery Inadequate exposure during the surgery

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>The length of Quadriceps incision was less than 2 cm. | Procedure: Quadriceps incision < 2 cm<br>* MIS-TKA was performed with less than 2 cm Quadriceps incision length<br>|
| Experimental: Group B<br>The length of Quadriceps incision was 2 to 4 cm. | Procedure: Quadriceps incision 2-4 cm<br>* MIS-TKA was performed with 2 to 4 cm Quadriceps incision length<br>|
| Experimental: Group C<br>The length of Quadriceps incision was more than 4 cm. | Procedure: Quadriceps incision > 4 cm<br>* MIS-TKA was performed with more than 4 cm Quadriceps incision length<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The recovery time of Quadriceps strength | Quadriceps strength was tested every month postoperatively, Recovery time was the amount of months which the Quadriceps strength returned to preoperative level. | Upto 6 months |
A Non-invasive Device to Remove Fluid From the Middle Ear

Study Overview
=================
Brief Summary
-----------------
A feasibility study for evaluating efficacy and satisfaction is treated using a non-invasive device for middle ear ventilation. The study is designed to test the device's effectiveness by encouraging the evacuation of fluid from the middle ear, aid in hearing improvement, pain relief and assessment of patient satisfaction with the use of the device.

Official Title
-----------------
EMD - A Non-invasive Device for Ventilating the Middle Ear Feasibility Study to Evaluate Efficiency and User Satisfaction

Conditions
-----------------
Otitis Media With Effusion

Intervention / Treatment
-----------------
* Device: Non-invasive device for middle ear ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with ear fluids (OME) according to a doctor's examination for at least 4-6 weeks. There is a progressive hearing impairment and a matching tympanum. In principle, these children (with OME and hearing impairment) meet the criteria and candidates for the analysis of inserting tubes of incontinence (buttons). Exclusion Criteria: First encounter: acute ear infection or Proper Otoscopy Second session: First review: Otoscopy / Timpneometry / Hearing test. Parallel treatment: acupuncture - tubes insertion - discontinuation of follow-up - cessation of the experiment initiated by parents

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 10 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Device: Non-invasive device for middle ear ventilation<br>* Daily use of the device<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Middle ear values of Tympanometry | Values will be compared to baseline values of Tympanometry | 10 weeks | 
| Middle ear ventilation evaluated by otoscopy | Otoscopy evaluation of ear ventilation will be compared to baseline values | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Auditory test | Values will be compared to baseline values of Auditory test | 10 weeks |
Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare two different preparation

Official Title
-----------------
Randomized Study on Removable PGE2 Vaginal Insert Versus PGE2 Intravaginal Gel for Cervical Priming and Labour Induction in Term Pregnancy

Conditions
-----------------
Cervical Ripening, Labor, Induced

Intervention / Treatment
-----------------
* Drug: Prostaglandin E2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton pregnancy cephalic presentation gestation of more than 37 Weeks confirmed by ultrasound Bishop score less than 7 Informed consent Exclusion Criteria: previous cesarean section (scarred uterus) polyhydramnios multiple pregnancy fetal malformation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Active Comparator: A<br>sustained release preparation of prostaglandin E2 | Drug: Prostaglandin E2<br> <br> |
| Active Comparator: B<br>short-acting (instant-released) preparation of prostaglandin E2 | Drug: Prostaglandin E2<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of vaginal deliveries within the 48 hours after cervical ripening |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of total vaginal deliveries |  | 48 hours | 
| Vaginal deliveries at 12 hours, 24 hours and 36 hours |  | 48 hours | 
| Number of hyperkinesia with or without fetal heart rate monitoring abnormalities |  | 48 hours | 
| Number of hypertonia with or without fetal heart rate monitoring abnormalities |  | 48 hours | 
| Apgar score at 5 min less or equal 7 |  | 48 hours | 
| Apgar score at 10 min less or equal 7 |  | 48 hours | 
| Arterial pH less or equal 7.20 |  | 48 hours | 
| Arterial base excess more than 12 |  | 48 hours | 
| Number of maternal post-partum haemorrhage |  | 48 hours | 
| Time to reach 3cm cervical dilatation |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostaglandin E2, Intravaginal gel, Bishop score, Induction of labor, randomized trial, Vaginal insert
Accuracy of Nexfin® and NIBP to Predict IBP

Study Overview
=================
Brief Summary
-----------------
The Nexfin monitoring device relies on noninvasive pressure measurement using a finger-cuff manometer, combined with NIRS technology. The accuracy of the signal is dependent on the degree of vascular unloading, which takes an period before optimal unloading is reached. The evolution of the degree of inaccuracy caused by inclomplete unloading is quantified, and the absolute and relative inaccuracy of the nexfin as a function of the time is determined compared to the invasive blood pressure (IBP). Secondly, the accuracy of the Nexfin to predict the IBP is compared with the accuracy of noninvasive blood pressure to predict the IBP.

Detailed Description
-----------------
In patients under stable anesthesia conditions, who have IBP and NIBP monitoring, the Nexfin will additionaly be connected. All data will be recorded for at least 30 minutes. NIBP will be measured every 5 minutes The evolution of the NIBP, IBP and Nexfin-derived blood pressure will be analysed to determine the evolution of inaccuracy due to incomplete vascular unloading and to determine the accuracy of Nexfin compared with NIBP to determine IBP.

Official Title
-----------------
Evolution of the Accuracy of the Nexfin Pressure Signal Compared to Invasive and Noninvasive Arterial Blood Pressure

Conditions
-----------------
Bloodpressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that are accepted for surgery Exclusion Criteria: Patients unable or unwilling to provide consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| surgical patients<br>120 Adult patients, that are having a routine surgical procedure. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vascular unloading time | time to optimal vascular unloading | Start till end of operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bloodpressure | accuracy of nexfin compared to NIBP and IBP | Start till end of operation |
Bright Light Therapy in Seasonal Affective Disorder (SAD)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the efficacy of bright light therapy in SAD. This is a placebo-controlled, double-blind randomized controlled trial (RCT).

Official Title
-----------------
Placebo-controlled, Double Blind RCT on the Efficacy of Bright Light Therapy in SAD

Conditions
-----------------
Seasonal Affective Disorder

Intervention / Treatment
-----------------
* Other: Bright light therapy
* Other: Inactive placebo-light


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a patient has, according to the DSM-IV-TR, a Major depression, recurrent episode, seasonal pattern, moderate or severe (classification code 296.32 and 296.33) HAMD-21 (included in the SIGH-SAD) sum score is ≥ 22 patient is over 18 years patient can read and understand the subject information sheet patient has signed the informed consent form patient is not pregnant Exclusion Criteria: patient has a lifetime psychotic disorder patient has a DSM-IV Axis I disorder other than some anxiety disorder evaluated by MINI patient has some DSM-IV-TR Axis II disorder, which is likely to interfere with the study treatment according to the investigator patient has alcohol or some other substance use dependence or misuse life-time suicide attempt, or any thought of suicide during the last month patients has some unstable somatic disorder patient uses some medication on regular basis patient uses some herbal psychotropic agencies patient is, in the opinion of the investigator, unsuitable for any reason patient is a member of the site personnel or their immediate families patient has had bright light therapy during the current episode patient has some eye disease (patient can, however, be myopic or hyperopic)

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bright light<br> | Other: Bright light therapy<br>* Bright light therapy<br>|
| Placebo Comparator: Inactive placebo-light<br> | Other: Inactive placebo-light<br>* In this arm, patients will not get any bright-light therapy in a double-blind setting<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission as defined by the SIGH-SAD |  | 28 (visit window from 26 to 30 days) days after the inclusion day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of the severity of symptoms as assessed by SIGH-SAD, Hamilton anxiety scale, and Beck depression inventory-21 |  | 28 (visit window from 26 to 30 days) days |
Colorado Adult Joint Assessment Scale (CAJAS) Validation

Study Overview
=================
Brief Summary
-----------------
To obtain evidence of content validity and reliability of the Colorado Adult Joint Assessment Scale (CAJAS), a clinician-reported outcome (ClinRO) measure, as adapted for use in a population of adults with moderate to severe hemophilia A treated with coagulation factor VIII (FVIII) therapy as secondary prophylaxis or episodic treatment.

Official Title
-----------------
Content and Psychometric Validation Study of the Colorado Adult Joint Assessment Scale (CAJAS) in Subjects With Moderate to Severe Hemophilia A Treated on Prophylaxis

Conditions
-----------------
Hemophilia A

Intervention / Treatment
-----------------
* Other: Colorado Adult Joint Assessment Evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, 18 to 50 years of age Diagnosis of moderate to severe hemophilia A (documented <1-2% Factor VIII Concentration [FVIII:C]) Willing to maintain current FVIII treatment regimen, whether prophylactic or on-demand, for the duration of the study Exclusion Criteria: Routine need for wheelchair or routine need for two canes or crutches Diagnosis of another bleeding disorder such as von Willebrand Disease Known event that would interfere with the scheduled CAJAS evaluations (e.g., elective joint surgery, vacation)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CAJAS evaluation<br> | Other: Colorado Adult Joint Assessment Evaluation<br>* Physical evaluation of 6 joints, ankles, knees and elbows<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colorado Adult Joint Assessment Score (CAJAS) |  | Up to 25 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemophilia
Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism

Study Overview
=================
Brief Summary
-----------------
Hypothyroidism is risk factor in atherosclerotic cardiovascular diseases, but there is a controversy in effect of subclinical hypothyroidism on cardiovascular diseases. We aim to estimate the relation between subclinical hypothyroidism and endothelial dysfunction and the effects of levothyroxine therapy on it. Patients with confirmed subclinical hypothyroidism by lab results will be randomized to two groups of treatment with one daily dose of 100 mg Levothyroxine or placebo. The flow-mediated dilation and intima media thickness are evaluated before and after the study.

Official Title
-----------------
Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism

Conditions
-----------------
Subclinical Hypothyroidism

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 to 65 confirmed subclinical hypothyroidism Exclusion Criteria: receiving of other treatments for hypothyroidism patients with other major medical disorders smoking hyperlipidemia obesity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levothyroxin<br>In the treatment group, daily doses of 100 mg of Levothyroxine will be administered every morning, half an hour before breakfast. | Drug: Levothyroxine<br> <br> |
| Placebo Comparator: Placebo<br>In the placebo group treatment regimen and advices are identical to that of the treatment group, except for using a pharmacologically neutral agent, with complete resemblance to the real treatment. | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline flow-mediated dilation at 2 months | Flow-mediated dilation will be assessed using standard method with a radiologist unaware to the study arms at baseline and then 2 months after treatment. | At baseline and then 2 months after treatment | 
| Change from baseline intima-media thickness at 2 months | Intima-media thickness will be assessed using standard method with a radiologist unaware to the study arms at baseline and then 2 months after treatment. | At baseline and then 2 months after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subclinical hypothyroidism, Atherosclerosis, Cardiovascular disease, Endothelial function, Prevention
Cerebrospinal Fluid Congestion in Spinal Stenosis Patients

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized spinal stenosis symptom was provocation due to cerebrospinal fluid congestion.

Conditions
-----------------
Spinal Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: neurogenic claudication more than 3months relief neurogenic claudication by lumbar flexion spinal stenosis symptom by physical exam. who can walk more than 30 min. Exclusion Criteria: vascular claudication by physical exam.( ABI <0.9) structural change in vertebral ( tumor, congenital deformity) operation history at spinal bone metallic foreign body peripheral polyneuropathy

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| CSF pressure at spinal canal | We can calculate CSF pressure at spinal canal by using phase contraast magnetic resonance image technique. | on time of recruitment |
Transgastric Peritoneoscopy and Appendectomy

Study Overview
=================
Brief Summary
-----------------
This study is a feasibility study. Patients with acute abdominal pain who are planning to undergo a diagnostic laparoscopy are asked to participate in the study. The aim of the study is to evaluate if transgastric peritoneoscopy is feasible.

Official Title
-----------------
Transgastric Diagnostic Peritoneoscopy (Laparoscopy) and Appendectomy - A Pilot Study

Conditions
-----------------
Abdominal Pain

Intervention / Treatment
-----------------
* Procedure: Transgastric peritoneoscopy (NOTES)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with acute abdominal pain Exclusion Criteria: Patient under 18 Patient who cannot understand information in Swedish Patients previously operated in upper part of the abdomen

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transgastric peritoneoscopy<br>Only one arm, feasibility study | Procedure: Transgastric peritoneoscopy (NOTES)<br>* Under general anesthesia an endoscope will be passed through the gastric wall into the peritoneal cavity to examine the peritoneal cavity. At the withdrawal of the endoscope, the gastric access in the stomach wall will be closed with T-tags.<br>* Other names: No more interventions;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test the feasibility of transgastric peritoneoscopy |  | When discharged from hospital, 1 month post-op and one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NOTES, Transgastric, Appendectomy, Safety, Feasibility