linjc16/ctgov huggingface dataset:
Biochemical Approach to Measuring Surgical Trauma

Study Overview
=================
Brief Summary
-----------------
This study will examine the magnitude and time course of changes in circulating (serum and plasma) biomarker concentrations associated with musculoskeletal injury created by total knee replacement surgery. The sensitivity to injury will be characterized by the changes in mean serum concentration before and after surgery. Specificity for the injured state will be evaluated comparing the baseline to peak change (injury response) with the pre-surgery to follow-up baseline fluctuation (i.e. measurement noise).

Official Title
-----------------
Further Development of a Biochemical Approach to Measuring Surgical Trauma to Musculoskeletal Tissues

Conditions
-----------------
Total Knee Replacement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Age 18 to 75 No musculoskeletal injury requiring medical attention in the past 3 months other than entirely related to worsening symptoms of the operative knee or spinal level. No musculoskeletal injury producing pain in the previous 2 weeks. No inflammatory disease other than osteoarthritis) No exercise with weights in the 2 weeks before surgery.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Total Knee Replacement Patients<br>Forty men and women ages 18-75 undergoing unilateral (n = 20) or bilateral (n = 20) knee replacement surgery with no musculoskeletal injury requiring medical attention in the past 3 months or producing pain in the previous 2 weeks and no inflammatory disease other than osteoarthritis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity of biomarkers in response to tissue injury |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee Replacement, Arthroplasty
Apical Pelvic Support in Infertility Patients

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate apical pelvic compartment support in infertility patients at the time of hysteroscopy. Apical pelvic compartment evaluation for pelvic organ prolapse will be performed in infertility patients undergoing hysteroscopy.

Detailed Description
-----------------
The incidence of pelvic organ prolapse in the whole population has been demonstrated several times in previous studies. However, pelvic floor defects in young infertility patients are not known. In this study, a clinical pelvic floor assessment with the pelvic organ quantification system will be performed in infertility patients during standard physical examinations or hysteroscopy.

Official Title
-----------------
Apical Pelvic Compartment Support in Infertility Patients

Conditions
-----------------
Infertility, Female, Pelvic Organ Prolapse, Pelvic Floor Disorders

Intervention / Treatment
-----------------
* Diagnostic Test: Pelvic Organ Prolapse Quantification system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages between 18-45 Patients who cannot become pregnant despite regular sexual intercourse for more than one year Exclusion Criteria: Malignity Patients who become pregnant during infertility assessment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infertility patients<br>Infertility patients will be examined according to the pelvic organ prolapse quantification classification system during hysteroscopy. | Diagnostic Test: Pelvic Organ Prolapse Quantification system<br>* The Pelvic Organ Prolapse Quantification system assessment tool measures nine anatomical points and distances in the vagina. The hymen is the reference point to which the other points are compared. The prolapsed organs are measured in centimeters to the hymen with an examination ruler.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stages of the pelvic organ prolapse | Once the measurements are taken, the infertility patients are assigned to the corresponding POP-Q stage. Stage-0 is no prolapse. Stage-1 stands for the most distal portion of the prolapse is more than 1 cm above the level of the hymen. Stage-2 stands for the most distal prolapse is between 1 cm above and 1 cm below the hymen (at least one point is -1, 0, or +1). Stage-3: The most distal prolapse is more than 1 cm below the hymen but no further than 2 cm less than total vaginal length. Stage-4 stands for the complete vaginal eversion. | 2 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pelvic organ prolapse, Infertility, Apical pelvic support
Vocal Intervention in Systemic Sclerosis

Study Overview
=================
Brief Summary
-----------------
Systemic sclerosis is a systemic connective tissue disease with physical and mental disturbances. Based on a pilot study the feasibility and effectiveness of a novel, self-developed concept of vocal intervention in Systemic Sclerosis under vocal pedagogical guidance and music therapy is assessed.

Detailed Description
-----------------
This concept aims at functional improvement of respiration and mouth-opening, enhancement of Quality of Life, and reduction of stress carried out by a music therapist and singer with pedagogical formation.

Official Title
-----------------
Rehabilitation in Patients Suffering From Systemic Sclerosis by Vocal Intervention: A Pilot Study

Conditions
-----------------
Systemic Sclerosis

Intervention / Treatment
-----------------
* Behavioral: vocal intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: positive criteria for Systemic Sclerosis according to the American College of Rheumatology/European League Against Rheumatism Exclusion Criteria: affection of the vocal apparatus dyspnea at rest oxygen prescription

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vocal intervention<br>Vocal intervention | Behavioral: vocal intervention<br>* 10 x 60 min. sessions of vocal intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MOS 36-Item Short Form Health Survey | The SF-36 - a patient-reported survey of patient health - consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mouth open; in millimeter | incisor to incisor; corner of mouth to corner of mouth; measurement by tape | up to 4 weeks | 
| 6-minutes walk test | The 6-minute walk test assess changes in functional exercise capacity with the primary outcome reported being the distance walked during the test. | up to 4 weeks | 
| Secretory immunoglobulin A; mg/l | Immunoglobulin A is an antibody that plays a role in immune function in the mucous membranes. Indicates changes in immune status. Collected by a swab placed in the mouth. | up to 4 weeks | 
| Saliva cortisol; ng/ml | Cortisol is a steroid hormone indicating changes in stress status. Collected by a swab placed in the mouth. | up to 4 weeks |
Fermentation Rate of Infant Formula

Study Overview
=================
Brief Summary
-----------------
It is hypothesized that there will be no difference in the breath hydrogen excretion between the 2 different prebiotic formulas.

Detailed Description
-----------------
This pilot study is looking at how a formula with one of two different prebiotic blends may alter the hydrogen level in an infant's exhalations in the hours after feeding. Higher levels for a longer period may signal higher levels of short chain fatty acids and bifidobacteria, both beneficial for gastrointestinal health. The higher levels may be the result of the formula undergoing a slower digestion, producing more fermentation. The study will compare a formula, similar to one currently on the market, with added prebiotics using a special breathing mask designed to be held to the infant's mouth and nose long enough to capture the infant's exhaled breath which will then be tested for Hydrogen content.

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 2-6 months of age, healthy,receiving standard cow-milk based infant formula weight, greater than 5th percentile Exclusion Criteria: on no antibiotics, breastfed, on solid foods

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 6 Months

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 |
| --- | --- |
| infants two to six months of age<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hydrogen content of breath |  | six hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
health benefits of infant formula
Ongoing Registry of Treatment of Venous Thromboembolism

Study Overview
=================
Brief Summary
-----------------
Ongoing registration of patients with venous thromboembolism treated by means of antithrombotic therapy, thrombolisys, open surgery, endovenous desobstruction and stenting.

Detailed Description
-----------------
Data of patients with VTE treated in different Russian medical centers are entered in a prospective digital database, and continuously updated. There is planned to conduct prospective randomized, cohort and observational studies on the site of register

Official Title
-----------------
Russian Registry of Treatment of Venous Thromboembolism

Conditions
-----------------
Deep Vein Thrombosis, Thromboses, Venous, Thrombosis Embolism, Postthrombotic Syndrome, Pulmonary Embolism

Intervention / Treatment
-----------------
* Drug: Anticoagulants
* Procedure: Open surgery
* Procedure: Thrombolysis
* Procedure: Venous stenting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: case of venous thrombosis of a limb or pulmonary embolus Exclusion Criteria: no exclusion criteria

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Anticoagulants|anticoagulation according to the main diagnosis|
|Procedure: Open surgery|removal of blood clots with open surgery|
|Procedure: Thrombolysis|removal of blood clots with thrombolysis|
|Procedure: Venous stenting|elimination of vein obstruction by stenting|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Veins patency | Change in patency target veins assessed by duplex ultrasonography in different follow up periods due to different treatment methods | Baseline, 3 and 12 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postthrombotic syndrome | the presence and severity of postthrombotic syndrome on the Villalta scale | Baseline, 3 and 12 months post-intervention | 
| QoL SF-36 | Change in Quality of Life (QoL), assessed by Short form 36 health survey (SF-36). Total scale range: from 0 to 800. SF-36 consists of 8 subscales. Each subscale range: 0 - 100. Subscales are combined using a special algorithm described in the instructions for the SF-36. For total scale the higher value represent the worse QoL. | Baseline, 3 and 12 months post-intervention | 
| QoL AVVQ | Change in Quality of Life (QoL), assessed by Aberdeen Varicose Vein Questionnaire (AVVQ). The AVVQ is a disease-specific QoL questionnaire aimed at venous disease. Total scale range: from 0 to 100, where the higher score represent worse QoL. | Baseline, 3 and 12 months post-intervention |
The Effect of High Dose Simvastatine on Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the effect of high doses of Simvastatine on bone metabolisme and biochemical markers of disease in Multiple Myeloma

Official Title
-----------------
The Effect of High Dose Simvastatine on Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Simvastatine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: multiple myeloma-patients in need of treatment stable og progressive disease age = or > 18 years performance status < 3 life expectancy > 3 months Exclusion Criteria: pregnancy patients incapable of giving personally concent renal insufficiens with creatinine clearance below 25 ml/min alanin aminotransferasis > 2,5 x upper reference limit thyroxine below lower reference limit known familiar muscle-disease ar previous myopati creatinine kinase > 10 x upper reference limit medication with drugs with known interactions wiht simvastatine

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Simvastatine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response estimated by internationally approved criteria after 8 weeks of intermittend treatment with simvastatine |  | 8 weeks after treatment start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in markers of bone metabolisme after 8 weeks of intermittend treatment with simvastatine |  | 8 weeks after start of treatment | 
| Toxicity according to CTC after 8 weeks of intermittend treatment with simvastatine |  | 8 weeks after start of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multiple myeloma, statins, bone
CeraShield™ Endotracheal Tube Feasibility Study

Study Overview
=================
Brief Summary
-----------------
Single-arm, feasibility study to evaluate the Ceragenin Coated Endotracheal Tube (the CeraShield ETT) in adults who require intubation and are expected to be mechanically ventilated for ≥ 24 hours.

Official Title
-----------------
CeraShield™ Endotracheal Tube Feasibility Study

Conditions
-----------------
Intubation, Intratracheal

Intervention / Treatment
-----------------
* Device: CeraShield Endotracheal Tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 18 years or older; Patients requiring a 7.0mm, 7.5mm, 8.0mm or 8.5mm endotracheal tube; Expected to be mechanically ventilated for ≥24 hours. Exclusion Criteria: Currently participating in another clinical trial which conflicts with this trial's design. Patients with a pre-existing respiratory infection, i.e., pneumonia. Patients with pulmonary contusions. Patients with cystic fibrosis. Patients demonstrating symptoms of bronchiectasis. Patients demonstrating symptoms of severe or massive hemoptysis. Severe or massive hemoptysis defined as greater than 500 ml of blood per day, or greater than 200 ml in six hours. Patients who have been intubated within the last 30 days requiring reintubation. Women of child-bearing potential who have not undergone a pregnancy test will be excluded from the study. Patient is pregnant.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CeraShield Endotracheal Tube<br>Subjects who are expected to require mechanical ventilation for 24 hours or longer will be intubated with the CeraShield ETT. | Device: CeraShield Endotracheal Tube<br>* Subjects requiring mechanical ventilation with be intubated with the CeraShield ETT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events | The safety of the CeraShield ETT tube will be assessed by reviewing adverse events in all patients enrolled in the study | Up to 30 days post enrollment or hospital discharge, whichever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive QEA | Determine the incidence of subjects with positive QEA in the patients intubated ≥ 24 hours | 10 days post intubation | 
| Positive ETT colonization | Determine the incidence of subjects with ETT colonization in the patients intubated ≥ 24 hours | 10 days post intubation |
Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study)

Study Overview
=================
Brief Summary
-----------------
Most studies of labour induction with misoprostol used doses higher than 25mg and intervals of 3-4 hours. We studied a low-dose regime of 25mg misoprostol and compared its efficacy as single dose or double dose with dosing interval of 6 hours to our current regime of 3 mg dinoprostone pessary.

Detailed Description
-----------------
171 women with singleton term pregnancies and modified Bishop score (mBS) ≤ 5 were recruited and randomized into 3 arms: current dinoprostone regime, double dose misoprostol or single dose misoprostol. The primary outcome was the number of women who achieved favourable mBS>6 or active labour by Day 2. Secondary outcomes were time interval from insert to active labour or delivery, abnormal uterine activity, delivery method and adverse neonatal outcome.

Official Title
-----------------
The Randomised-Controlled Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study)

Conditions
-----------------
Induction of Labour

Intervention / Treatment
-----------------
* Drug: Misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton pregnancy, cephalic presentation, gestation greater than 37 completed weeks, no known contraindication to vaginal delivery, and Bishop score≤5. Exclusion Criteria: previous caesarean section or other uterine surgery, significant maternal medical/obstetric complication in pregnancy (such as severe pre-eclampsia, significant antepartum haemorrhage), antepartum evidence of fetal compromise (such as fetal growth restriction), previous attempt at cervical priming, contraindication to receiving prostaglandins, including asthma and glaucoma.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Misoprostol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome was the number of women who achieved favourable mBS>6 or active labour by Day 2. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes were time interval from insert to active labour or delivery, abnormal uterine activity, delivery method and adverse neonatal outcome. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low dose misoprostol, dinoprostone, cervical priming