linjc16/ctgov huggingface dataset:
Postoperative Analgesia With Local Infiltration After Hip Fracture Of Intertrochanteric Type

Study Overview
=================
Brief Summary
-----------------
Reducing pain is an essential factor for early mobilization after osteosynthesis of intertrochanteric fractures. Systemic opioids have side effects that might obstruct mobilization and induce delirium and nausea. The investigators hypothesized that wound infiltration results in reduction in systemic opioid usage and pain relief without side effects.

Official Title
-----------------
Postoperative Analgesia With Local Infiltration After Hip Fracture Of Intertrochanteric Type

Conditions
-----------------
Hip Fracture of Intertrochanteric Type

Intervention / Treatment
-----------------
* Drug: Ropivacaine
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intertrochanteric hip fracture Fracture due to low energy trauma Ability to understand danish and give informed consent Ability to walk before trauma Indication for osteosynthesis •≥ 8 in OMC (Orientation-Memory-Concentration) test with a possible maximum of 28 points Informed consent Exclusion Criteria: Drug or medical abuse Drug intolerance Pathological fractures Inflammatory arthritis Patient included in the study with the contralateral hip
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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ropivacaine<br> | Drug: Ropivacaine<br>* Approved by the Danish Medicines Agency<br>Drug: Saline<br>* Approved by the Danish Medicines Agency<br>|
| Placebo Comparator: Saline<br> | Drug: Saline<br>* Approved by the Danish Medicines Agency<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumption of opioids |  | 5 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | 5 days postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip fracture, intertrochanteric
Pathological Tumor and Lymph Node Responses After Neoadjuvant Immunochemotherapy in Initially-unresectable NSCLC

Study Overview
=================
Brief Summary
-----------------
This is a real-world study with the largest sample size investigating the pathological tumor and lymph node responses to neoadjuvant immunochemotherapy in non-small cell lung cancer to date. Patients with initially unresectable NSCLC underwent immunochemotherapy and response to treatment was assessed after every two treatment cycles. Clinicopathologic features of patients including epidemiological data, clinical manifestations, operation strategies, pathological findings, and prognostic information were recorded and evaluated.

Official Title
-----------------
Real-world Analysis of Pathological Tumor and Lymph Node Responses After Neoadjuvant Immunochemotherapy in Initially-unresectable Non-small Cell Lung Cancer

Conditions
-----------------
Non Small Cell Lung Cancer, Immunotherapy, Chemotherapy, Tumour, Residual

Intervention / Treatment
-----------------
* Drug: Timing of drug administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with stage III NSCLC who received neoadjuvant immunochemotherapy. early-stage NSCLC patients who were initially unresectable. 18 years of age or older. Karnofsky performance status (KPS) score of 100 or 90. Exclusion Criteria: Patients with stage IV NSCLC Patients with known ALK translocations or EGFR mutations. Karnofsky performance status (KPS) score <90.

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 |
| --- | --- |
| combined well responder<br>Both primary tumor and nodal response achieve major pathological response (MPR). | Drug: Timing of drug administration<br>* The effect of drug administration timing on tumor and lymph node responses was observed.<br>|
| poor responder<br>Primary tumor or/and nodal response can not achieve MPR. | Drug: Timing of drug administration<br>* The effect of drug administration timing on tumor and lymph node responses was observed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival | the time from diagnosis to any progression of disease precluding surgery, progression or recurrence of disease after surgery or death from any cause. | At least one year |
A Registered Cohort Study on Brain Calcification

Study Overview
=================
Brief Summary
-----------------
Brain calcification is a common neuroimaging feature in patients with metabolic, neurological, or developmental disorders, infectious diseases, traumatic or toxic history, as well as in otherwise normal older people. To understand the clinical and genetic characteristics of brain calcification, we establish a cohort of brain calcification to follow up patients with brain calcification.

Official Title
-----------------
A Registered Cohort Study on Brain Calcification

Conditions
-----------------
Brain Calcification

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with brain calcium deposit(s) based on examinations of CT scans Patients with total calcification score(TCS) greater than the physiological threshold Relatives of brain calcification patients. Unrelated healthy controls Participants or Parent(s)/legal guardian(s) willing and able to complete the informed consent process Exclusion Criteria: Brain calcification caused by specific secondary factors such as infection, poisoning, and trauma Participants declining or unable to comply with trial procedures and visit schedule
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 |
| --- | --- | --- |
| The incidence of hereditary brain calcification | Look for the causative gene in the patient with brian calcification | Up to 20 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brain calcification, natural history, genetics
Use of a Wearable Digital Cognitive Aid in Simulated Anesthesia and Intensive Care Crises.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a wearable digital cognitive aid has an effect in the management of simulated crises in anesthesia or intensive care.

Detailed Description
-----------------
 Errare humanum est , to err is human. This Latin saying attributed to Seneca shows that since the dawn of time, human beings are aware that managing complex situations will always be an inexhaustible source of mistakes. This is particularly true in anesthesia and intensive care in which situations are often complex and stressful, thus leading to mistakes or inadequate management. Improvement might arise from the use of cognitive aids. The investigators designed a smartphone application including 5 scenarios of anesthesia and intensive care crises (malignant hyperthermia, anaphylactic shock, acute toxicity of local anesthetics, severe and symptomatic hyperkaliemia, ventricular fibrillation), easy to use with a manual validation of every simple step. Investigators seek to compare the technical and non technical management of these crises with and without this wearable cognitive aid.

Official Title
-----------------
Use of a Wearable Digital Cognitive Aid in Simulated Anesthesia and Intensive Care Crises.

Conditions
-----------------
Cognitive Aids

Intervention / Treatment
-----------------
* Device: Digital cognitive aid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resident Physicians training in Anesthesia/Intensive care (same specialization in France), year 2 to 5 (out of 5) Exclusion Criteria: All other residents, including Resident Physicians training in Anesthesia/Intensive care, year 1 (out of 5)
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital Aid<br>The digital cognitive aid is designed as a smartphone app. Intervention : cognitive aid during anesthesia and intensive care crises management. | Device: Digital cognitive aid<br>* Digital cognitive aid during anesthesia and intensive care crises.<br>|
| No Intervention: No digital aid<br>Anesthesia and intensive care crises managed without any cognitive aid. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Performance as compared to a Reference Task List | Number of tasks successfully performed, rated on remote video review | Time 0-30 min |
Energy Expenditure in Golf

Study Overview
=================
Brief Summary
-----------------
Structured exercise and physical activity are well known to not only improve physical fitness, but also alter various health parameters in a positive fashion. To yield health benefits, exercises need to meet certain characteristics e. g. specific levels of intensity or duration.To evaluate intensity levels and therefor possible improvements in physical conditioning in golf the investigators conducted this study with two groups of each 10 subjects. The groups differed in age and skill level (handicap, hcp). Each group went through a exercise session on the driving range (DR) and a 9-hole compeition round of golf. The investigators assessed spirometrical data (breath-by-breath) to evaluate energy expenditure (EE) and intensity levels of physical activity according to the ACSM guidelines.

Official Title
-----------------
Physical Activity and Energy Expenditure in Golf

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

Intervention / Treatment
-----------------
* Other: EE Golf


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male age 18 to 45 y Body-Mass-Index: under 30 kg/m2 Handicapclasses 1,2 und 4 healthy Exclusion Criteria: contraindication (orthopaedic, cardiologic, etc.) to participating in physical exhausting force and endurance testing and playing golf acute or chronical inflammation intake of drugs and medication

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LOW<br>Golf Skill level high, handicap below 11.5 | Other: EE Golf<br>* Exercise in Golf and Playing 9 holes<br>|
| HIGH<br>Golf Skill level low, handicap 18.5 - 26.4 | Other: EE Golf<br>* Exercise in Golf and Playing 9 holes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Äquivalent of Task (MET) | 1 MET = 3.5 mL of oxygen per kilogram bodyweight per minute | 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Heart Rate | Heartrate in in relation to maximum heartrate | 90 minutes | 
| Percent VO2 | oxygen uptake in relation maximum oxygen uptake (VO2peak) | 90 minutes | 
| Duration of Intensity levels in METs | Relative time spent in intensity levels | 90 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical activity, Golf, Exercise, Energy consumption, METs
A Phase II Randomized Open Label Study of KLH-2109 in Patients With Endometriosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis.

Official Title
-----------------
A Multicenter, Randomized, Open Label Phase II Study of KLH-2109 in Patients With Endometriosis(3)

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Drug: KLH-2109
* Drug: KLH-2109


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients with endometriosis Exclusion Criteria: Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Drug:KLH-2109 lower dose<br> | Drug: KLH-2109<br> <br> |
| Experimental: Drug:KLH-2109 higher dose<br> | Drug: KLH-2109<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The severity score of the pelvic pain |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gonadotropin-Releasing Hormone (GnRH) antagonist
Nicardipine Versus Labetalol During Intubation

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to compare the efficacy of nicardipine and labetalol in attenuation of cardiovascular responses to endotracheal intubation.

Conditions
-----------------
Patients Who Are Intubated for General Anesthesia, Endotracheal Intubation

Intervention / Treatment
-----------------
* Drug: labetalol
* Drug: nicardipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for general anesthesia with endotracheal intubation Exclusion Criteria: Patients with heart failure or coronary artery disease 2-3 degree atrio-ventricular block or severe bradycardia (< 45 beats/min) asthma, bronchial spasm or chronic obstructive pulmonary disease patients with anticipated difficult intubation (Mallampati class III, IV) severe hepatic or renal dysfunction allergy or contraindication to study medication

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group L<br>0.4 mg/kg labetalol | Drug: labetalol<br>* 0.4 mg/kg labetalol intravenously 4 min before intubation<br>|
| Active Comparator: group N<br>20 ㎍/kg nicardipine | Drug: nicardipine<br>* 20 ㎍/kg nicardipine intravenously 4 min before intubation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic variables (systolic blood pressure, diastolic blood pressure and mean blood pressure, heart rate) |  | preinduction- 10 min after intubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients who are intubated for general anesthesia
A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.

Official Title
-----------------
A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Open-angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension
* Drug: Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Diagnosis of open-angle glaucoma or ocular hypertension Other protocol-defined inclusion criteria may apply Exclusion Criteria: Under 18 Pregnant Other protocol-defined exclusion criteria may apply

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brinzolamide + Timolol<br> | Drug: Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension<br>* One drop in the study eye(s) twice daily for 12 months<br>|
| Active Comparator: Dorzolamide + Timolol<br> | Drug: Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT)<br>* One drop in the study eye(s) twice daily for 12 months<br>* Other names: COSOPT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean IOP |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent patients with IOP < 18 mmHg |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
open-angle glaucoma, ocular hypertension
Airway Vascular Lesions

Study Overview
=================
Brief Summary
-----------------
Controversy exists in the treatment of airway hemangiomas ranging from tracheotomy, various lasers, to open removal, none of which have proven to be a gold standard. Venous malformations of the airway are difficult to treat and also require laser therapy or open removal and often repeated treatments are required. Similarly airway lymphatic malformations can require multiple treatment modalities as well as multiple procedures and are infrequently eradicated when extensive. New uses for various lasers and differing treatment protocols are frequently developed. Review of the treatment modalities and efficacy of these methods is required. The goal of this research is to determine protocols for treatment of airway vascular malformation and to evaluate our results from treatment of these lesions.

Official Title
-----------------
Airway Vascular Lesions

Conditions
-----------------
Hemangiomas, Venous Malformations, Lymphatic Malformations

Intervention / Treatment
-----------------
* Other: Protocols for Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Airway Vascular Lesion Exclusion Criteria: None at this time
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Protocols for Treatment|Determine protocols for treatment of airway vascular malformation and to evaluate results from treatment of these lesions.|

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
-----------------
Airway, Hemangiomas, Venous Malformations, Lymphatic Malformations
Prospective Study on Polypectomy Complications: SPoC.

Study Overview
=================
Brief Summary
-----------------
Colonoscopy has been shown to reduce both the colo-rectal cancer incidence and mortality, due to its capability to detect and remove precancerous lesions. However, polypectomy is associated with complications, such as bleeding and perforation, with an estimated overall incidence of about 10%, with polyp size and right-sided location considered as major risk factors. Aim of present study was to prospectively evaluate the early and delayed (30-days follow-up) complications of polypectomy in a multicenter regional Italian real practice setting

Conditions
-----------------
Endoscopic Polypectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients undergoing endoscopic polypectomy Exclusion Criteria: pregnancy incapacity to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| colonoscopy population<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications of endoscopic polypectomy |  | 3 months |