linjc16/ctgov huggingface dataset:
Pilot Study Comparing Two Techniques of Taking Care Analgesic in Patients 70 and Older, Awaiting Surgery After Extracapsular Fracture of the Proximal Femur

Study Overview
=================
Brief Summary
-----------------
The fracture of the proximal femur is a common traumatic pathology in patients aged over 70 years, associated with a mortality of 20 to 30% a year. The care is delayed emergency. During this wait, the occurrence of heel pressure ulcers is regularly found, despite wearing antiescarres slippers. Mobilization, source of pain, is also problematic. 759/5000

Official Title
-----------------
Pilot Study Comparing Two Techniques of Taking Care Analgesic in Patients 70 and Older, Awaiting Surgery After Extracapsular Fracture of the Proximal Femur

Conditions
-----------------
Femoral Fractures

Intervention / Treatment
-----------------
* Other: traction-stuck
* Other: a pillow between the legs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 70 and over, Extracapsular fracture isolated from the proximal end of the femur, Informed consent of the patient for participation in the study, Patient affiliated to a social security scheme. Exclusion Criteria: Restlessness or fragile skin condition that may prevent the establishment or maintenance of traction stuck preoperatively Insane or confounding Pathology, Predictable time before operation> to 72 hours (eg anticoagulated patient orally before the fracture [antiplatelet agents are allowed], other associated diseases: urinary tract infection, pneumonia ...) Patient under guardianship, curatorship, or under judicial protection.

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a pillow between the legs versus traction-stuck
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: a pillow between the legs<br> | Other: a pillow between the legs<br>* setting up a pillow between the legs before the care<br>|
| Experimental: traction-stuck<br> | Other: traction-stuck<br>* continuous pulling method: tensile force is exerted directly on the skin by means of adhesive strips, connected to weight<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score from pain immediately after washing, the day of surgery preoperatively |  | 5 minutes |
3 Year Recurrence Free Survival in Ultra-low-risk Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
To verify the safety of omission of lymph node dissection in ultra-low-risk endometrial cancer (KGOG criteria), we examine the survival of women with ultra-low-risk endometrial cancer who do not undergo lymph node dissection

Official Title
-----------------
Three-year Recurrence Free Survival in Patients With Ultra-low-risk Endometrial Cancer Who do Not Undergo Lymph Node dissEction

Conditions
-----------------
Endometrial Cancer

Intervention / Treatment
-----------------
* Procedure: no lymph node dissection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: endometrioid type anticipated surgery omitting lymph node dissection for endometrial cancer pelvis MRI, CA125 - satisfying KGOG criteria no distant metastasis age 19 or more Exclusion Criteria: other cancer within 5 yr previous hysterectomy previous therapy for endometrial cancer

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental<br>women who do not undergo lymph node dissection | Procedure: no lymph node dissection<br>* do not undergo lymph node dissection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 year recurrence free survival | 3 year recurrence free survival | 3 year since surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5 year recurrence free survival | 5 year recurrence free survival | 5 year since surgery | 
| 5 year overall survival | 5 year overall survival | 5 year since surgery | 
| surgery time | from surgery start to end | surgery visit | 
| change of Functional Assessment of Cancer Therapy - General (FACT G) score from baseline | functional assessment of cancer therapy - general | baseline - 1week - 5week - 3month - 6month | 
| change of Gynecologic Cancer Lymphedema Questionnaire - Korean (GCLQ-K) score from baseline | gynecologic cancer lymphedema questionnaire - Korean | baseline - 5week - 6month - 12month - 18month - 24month - 36month - 48month - 60month | 
| change of Female Sexual Function Index (FSFI) score from baseline | female sexual function index | baseline - 6month - 12month - 24month - 36month - 48month - 60month | 
| length of stay | from admission to discharge | surgery visit | 
| transfusion | amount of transfusion | surgery visit | 
| hemoglobin decline | change of hemoglobin level from baseline to postoperative lowest level | surgery visit | 
| surgery complication | any surgery complications observed | surgery visit |
Ferrous Sulphate Supplement (V0355) in Women With Iron Deficiency Anaemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the pharmacokinetics of serum iron after a single oral administration of 160 mg (2 tablets of 80 mg) V0355 in women with iron deficiency anaemia.

Official Title
-----------------
Study of the Pharmacokinetics of Serum Iron After a Single Oral Administration of Ferrous Sulphate Supplement Synthetic Formula in Women With Iron Deficiency Anaemia.

Conditions
-----------------
Iron Deficiency Anemia

Intervention / Treatment
-----------------
* Drug: V0355


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 18-45 years inclusive with iron deficiency anaemia haemoglobin level between 85 g/L and 105 g/L serum ferritin level < 15 µg/L D14 +/- 7 days of the menstruation cycle on the day of pharmacokinetic evaluation Exclusion Criteria: Anaemia related to other causes than iron deficiency and particularly inflammatory anaemia, anaemia due to marrow failure, haemopathy, haemoglobinopathies (sickle cell disease, thalassemia), haemolytic anaemia, anaemia due to acute haemorrhage, or anaemia related to chronic renal failure, Haemochromatosis or iron overload of secondary origin (blood transfusion), Long term treatment known to modify iron absorption, Gastro duodenal ulcer, Inflammatory bowel disease or any digestive disease which could modify iron absorption, Serious or progressive disease (cardiac, pulmonary, hepatic, renal, haematological, malignancy, autoimmune disease, infectious disease or neuropsychiatric disorders), Surgery undergone within 1 month prior to selection visit or a surgery planned during the study realization.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug<br> | Drug: V0355<br>* Oral administration (2 tablets)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma concentration (Cmax) |  | up to 24 hours after oral administration | 
| Time to Maximum Concentration (Tmax) |  | up to 24 hours after oral administration | 
| Area under the iron plasma concentration curve (AUC) |  | up to 24 hours after oral administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of single administration | Tolerability by evaluating the number of subjects with emergent adverse events | Up to 24 hours |
The Use of Sun Protection After Hamam (Turkish Bath)

Study Overview
=================
Brief Summary
-----------------
Hamam is a common spa treatment. During a Hamam, some of the outermost layer of the skin is removed. The investigators believe that partly removing a protective skin layer might increase the risk of sun burn, especially for skin that has not been exposed to sun for a long time. The aim with this study is to assess if Hamam-treated skin is more susceptible to sun burn compared with untreated skin.

Official Title
-----------------
The Use of Sun Protection After Hamam (Turkish Bath): a Randomized, Controlled, Blinded Trial

Conditions
-----------------
No Medical Condition

Intervention / Treatment
-----------------
* Procedure: Hamam treated skin and sun exposure
* Other: Untreated skin and sun exposure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years Healthy volunteers Skin types 1,2,3- Fitzpatrick scale Provided informed consent Exclusion Criteria: Regular medication for a condition/disease Active skin disease Sun exposure on the back within four weeks prior to the start of the study History of premalignant or malignant skin lesions Tattoo covering more than half of the back

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each participant will be randomized to receive Hamam on either the left or the right side of the back. The other side will be left untreated. Each individual will thereafter receive a sun exposure of both the Hamam-treated skin and the untreated skin.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hamam treated skin and sun exposure<br> | Procedure: Hamam treated skin and sun exposure<br>* Hamam is a skin treatment (soaping and scrubbing).<br>|
| Other: Untreated skin and sun exposure<br> | Other: Untreated skin and sun exposure<br>* Skin that will not receive Hamam.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin erythema | Change in skin erythema: comparison of Hamam treated skin with untreated skin. Photographs of the skin will be assessed by computer analysis. | Baseline until 24 hours after sun exposure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin erythema | Measured by a visual scale. | Baseline until 24 hours after sun exposure. | 
| Pain | Measured by a visual analogue scale. | Baseline until 24 hours after sun exposure. |
Antibiotic Therapy for Infectious Diseases

Study Overview
=================
Brief Summary
-----------------
Tigecycline is a last-resort antibiotic that is used to treat severe infections caused by extensively drug-resistant bacteria. However, the efficacy and safety data for tigecycline in infectious patients are lacking. The aim of this study is to assess the efficacy and safety of tigecycline in infectious patients using pharmacokinetics and omics.

Official Title
-----------------
The Efficacy and Safety of Tigecycline for the Treatment of Infectious Diseases

Conditions
-----------------
Infectious Disease

Intervention / Treatment
-----------------
* Drug: Tigecycline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: critically ill hospitalized males or nonpregnant females aged 18 years with severe infections which the treating clinician was treating with tigecycline Exclusion Criteria: severe liver dis- eases (e.g., Child-Pugh score C); patients allergic to tetracycline and tigecycline; those who have participated in other clinical trials, or those who are considered unsuitable by researchers; pregnant women and lactating women.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tigecycline|Efficacy and safety of Tigecycline|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Drug-related adverse events and serious adverse events | Through study completion, an average of 15 days | 
| Pharmacokinetics of tigecycline | clearance in L/h | Through study completion, an average of 3 days | 
| Rate constant for tigecycline distribution | Pharmacokinetics of tigecycline | Through study completion, an average of 3 days | 
| The ratio of area under the concentration-time curve (AUC) to minimum inhibitory concentration (MIC). | PD target | Through study completion, an average of 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fibrinogen levels in mg/dL |  | Through study completion, an average of 3 days | 
| prothrombin time | prothrombin time in second | Through study completion, an average of 3 days | 
| activated partial thromboplastin time | activated partial thromboplastin time in second | Through study completion, an average of 3 days | 
| international normalized ratio | international normalized ratio，INR | Through study completion, an average of 3 days | 
| blood platelet count | blood platelet count in ×10^9/L | Through study completion, an average of 3 days | 
| thrombin time | thrombin time in second | Through study completion, an average of 3 days |
Comparative Efficacy of Lidocaine Spray Versus Vaginal Dinoprostone in IUD Insertion

Study Overview
=================
Brief Summary
-----------------
the aim of this study is to compare the safety and Efficacy of Lidocaine Spray Versus Vaginal dinoprostone in relieving pain during levonorgestrel IUD Insertion in nulliparous women

Official Title
-----------------
Comparative Safety and Efficacy of Lidocaine Spray Versus Vaginal Dinoprostone in Relieving Pain During Levonorgestrel IUD Insertion

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: lidocaine spray
* Drug: vaginal dinoprostone
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nulliparous women requesting levonorgestrel IUD insertion Exclusion Criteria: multiparous women, allergy or contraindication to study drugs or contraindications to LNG-IUD insertion
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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lidocaine spray<br>four puffs (50ml, 10 mg/puff) of lidocaine spray will be applied to the cervical canal and cervix before tenaculum placement plus vaginal placebo will be given 3 hours before IUD insertion | Drug: lidocaine spray<br>* four puffs (50 ml, 10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion<br>|
| Active Comparator: vaginal dinoprostone<br>vaginal dinoprostone 3 mg will be given 3 hours before IUD insertion plus four puffs of saline spray will be applied to the cervical canal and cervix before tenaculum placement | Drug: vaginal dinoprostone<br>* vaginal dinoprostone 3 mg will be given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement<br>|
| Placebo Comparator: placebo<br>vaginal placebo will be given 3 hours before IUD insertion plus four puffs of saline spray will be applied to the cervical canal and cervix before tenaculum placement | Drug: placebo<br>* vaginal placebo will be given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain during IUD insertion | pain during IUD insertion assessed by 10 cm visual analog scale where 0 denotes no pain and 10 denotes the worst pain imaginable | 2 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insertion duration | duration of LNG-IUD insertion from speculum in to speculum out | 5 minutes |
How Much is Too Much: Assessing Varying Pressure Pump Pressures in Post Operative Pain Control in Shoulder Arthroscopy.

Study Overview
=================
Brief Summary
-----------------
Postoperative surgical pain has been extensively study with regard to anaesthesia pain modalities, however little is published with regards to various arthroscopic shoulder surgical techniques. An intriguing characteristic of shoulder arthroscopy is the various arthroscopic pump pressures used by different surgeons. One could hypothesize that excessive water retention from the arthroscopic pump could causes excessive tissue pressure and swelling resulting in post operative pain. Unfortunately we could not find any literature in the English language regarding varying pressure pump settings on post operative pain control. For that reason we would like to assess how variable pump pressure effect tissue pressure over pre set time points, and how this may relate to post operative pain control.

Official Title
-----------------
How Much is Too Much: Assessing Varying Pressure Pump Pressures in Post Operative Pain Control in Shoulder Arthroscopy.

Conditions
-----------------
Shoulder Arthroscopy

Intervention / Treatment
-----------------
* Procedure: Arthroscopic rotator cuff repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients attending St. Joseph's hospital Shoulder pathology amenable to arthroscopic surgery Medically suitable for surgical management Able to consent for surgery. Exclusion Criteria: Unable to consent Active infection Active malignancy Drug or alcohol misuse Work related injury Lack of permanent home residence Previous surgery to affected shoulder Medical contraindiction to surgery Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 25mmHg pressure<br>Pump pressure of 25mmHg during rotator cuff repair | Procedure: Arthroscopic rotator cuff repair<br> <br> |
| Experimental: 45mmHg pressure<br>Pump pressure of 45mmHg during rotator cuff repair | Procedure: Arthroscopic rotator cuff repair<br> <br> |
| Experimental: 65mmHg pressure<br>Pump pressure of 65mmHg during rotator cuff repair | Procedure: Arthroscopic rotator cuff repair<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain - VAS scale |  | Two years |
Sensitivity and Specificity of Urinary Dipstick in Emergency Departments

Study Overview
=================
Brief Summary
-----------------
Urinary dipsticks are commonly used in emergency departments since they are a cheap and quick diagnostic tool. However the sensitivity and specificity of urinary dipsticks might be compromised in emergency departments due to fluid imbalance and acute illness itself.

Detailed Description
-----------------
The study is designed as a prospective observational study on the emergency department in Sonderborg, Southern Denmark. All patients above 18 years of age who have given their consent are included. Urinary dipstick and albumin creatinine ratio is obtained simultaneously within 48 hours after admission on the emergency department. Patient with a positive urinary dipstick will be asked to deliver another urinary dipstick and albumin creatinine ratio 3-8 weeks later. To our knowledge has the specificity and sensitivity of urinary dipstick for protein not been described, yet. Our design will give us the possibility not only to quantify specificity and sensitivity in the acute phase on the emergency department but in the non-acute phase after discharge from the emergency department, as well.

Official Title
-----------------
Sensitivity and Specificity of Urinary Dipstick in Emergency Departments

Conditions
-----------------
Proteinuria

Intervention / Treatment
-----------------
* Diagnostic Test: Urinary dipstick


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients above 18 years of age who were admitted to the emergency department in Sonderborg and who gave their consent Exclusion Criteria: anuria

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Urinary dipstick|Sensitivity and specificity of urinary dipstick for proteinuria in emergency departments|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of urinary dipstick for proteinuria on emergency departments |  | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urinary dipstick, emergency department