linjc16/ctgov huggingface dataset:
Pain After Cesarean Sectio.

Study Overview
=================
Brief Summary
-----------------
To study the strength of postoperative pain 0-24 hrs after elective cesarean sectio in spinal anaesthesia.

Official Title
-----------------
Postoperative Pain 0-24 hr After Cesarean Sectio

Conditions
-----------------
Pain, Analgesic Medication

Intervention / Treatment
-----------------
* Procedure: cesarean sectio


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cesearean sectio Exclusion Criteria: none

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: cesarean sectio|consecutive parturients due for cesarean sectio|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain strenght | NRS pain | 0-24 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rescue drug needed | dose of rescue opioid drug | 0-24 hrs |
Pentastarch Use in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Patients undergoing cardiac surgery with cardiopulmonary bypass require significant fluid administration. Fluids are used routinely to replace blood lost during and after surgery. Significant amounts of fluid are also used to prime the tubing and components of the cardiopulmonary bypass pump before and during its use. The use of Pentaspan - a synthetic pentastarch - was started because of the restriction of use for blood and blood products, particularly albumin. Pentaspan is usually used after surgery in the Intensive Care Unit (ICU). The impact of the use of pentastarch on coagulation, fluid balance and bleeding are very limited. This study will methodically evaluate the impact of using increasingly greater amounts of pentastarch during surgery on an open heart surgery patient's recovery in particular - is there more bleeding, does his/her blood clot as well, and how much fluid overall is used and excreted?

Official Title
-----------------
A Randomized, Prospective, Blinded Clinical Trial to Evaluate the Efficacy and Safety of Pentastarch Use in Patients Undergoing Coronary Artery Bypass Surgery or Valve Replacement Surgery Using Cardiopulmonary Bypass Circuits

Conditions
-----------------
Cardiac Surgery, Cardiopulmonary Bypass

Intervention / Treatment
-----------------
* Drug: Pentastarch (displace either 500 ml or 1000 ml of pump prime with pentastarch)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing either coronary artery bypass surgery or valve surgery requiring the use of cardiopulmonary bypass circuit Exclusion Criteria: Emergency surgery Regurgitant valve pathology Redo surgery Significant left ventricular (LV) dysfunction Significant renal insufficiency Anticipation of associated procedure - eg carotid endarterectomy Ongoing sepsis or endocarditis Received aspirin (ASA) or Plavix within 96 hours of surgery
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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pentastarch (displace either 500 ml or 1000 ml of pump prime with pentastarch)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transfusion requirements |  |  | 
| fluid balance |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative bleeding |  |  | 
| mediastinal drainage |  |  | 
| coagulation parameters |  |  | 
| respiratory status |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients undergoing cardiac surgery requiring cardiopulmonary bypass
Biobank For MS And Other Demyelinating Diseases

Study Overview
=================
Brief Summary
-----------------
To establish a large, longitudinal collection of high quality samples and data from subjects with MS, selected other demyelinating diseases (Transverse Myelitis (TM), Neuromyelitis Optica (NMO) or Devic's, Acute Disseminated Encephalomyelitis (ADEM), and Optic Neuritis (ON)), and related and unrelated unaffected controls. Samples and data will be available as a shared resource to scientists researching the causes, sub-types, and biomarkers of MS and related demyelinating diseases.

Official Title
-----------------
Large-scale, Multi-disciplinary Sample and Data Repository for Multiple Sclerosis and Related Demyelinating Diseases

Conditions
-----------------
Multiple Sclerosis, Transverse Myelitis, Neuromyelitis Optica, Acute Disseminated Encephalomyelitis, Optic Neuritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18+ able to give informed consent or individuals younger than 18 with parental permission and able to give assent willing to provide up to 110 ml (50 ml for < 18 years old) of blood via venipuncture experienced at least one CNS demyelinating event characteristic of MS, TM, NMO, ADEM, or ON Exclusion Criteria: history of blood borne pathogens allogeneic bone marrow transplant clinical or radiological evidence of stroke, meningitis, or other well characterized diseases of the nervous system (with the exception of MS, TM, NMO, ADEM, or ON). weight less than 37 pounds
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 |
| --- | --- |
| Case<br> | |
| Control<br> | |

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
-----------------
Multiple Sclerosis, Clinically Isolated Syndrome, Transverse Myelitis, Neuromyelitis Optica, Acute Disseminated Encephalomyelitis, Optic Neuritis, Repository, Biobank
Polyneuropathy in Diabetes Mellitus Type 2

Study Overview
=================
Brief Summary
-----------------
This is a population-based study of type 2 diabetes patients with and without neuropathy recruited from the Danish National Type 2 Diabetes cohort (DD2). Perspective: The study will identify risk factors for developing diabetic polyneuropathy and painful diabetic polyneuropathy and provide information on the underlying mechanisms, which will hopefully contribute to significant improvements in the treatment and prevention of diabetic polyneuropathy in future.

Detailed Description
-----------------
Diabetic polyneuropathy is one of the most common long-term complications of diabetes. Neuronal hyperexcitability is thought to be a key factor in the development of neuropathic pain. The overall purpose of this study is to evaluate the prevalence and underlying mechanisms of diabetic polyneuropathy and painful diabetic polyneuropathy.

Official Title
-----------------
Polyneuropathy in Diabetes Mellitus Type 2

Conditions
-----------------
Chronic Pain, Diabetes Mellitus Type 2 Without Complication, Polyneuropathies, Diabetic, Diabetes Complications, Diabetic Peripheral Neuropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria T2D patients: Clinical diagnosis of type 2 diabetes Exclusion Criteria: Pregnancy Poor or no Danish language skills Insufficient mental capacity to provide informed consent or complete questionnaires Additional criteria for healthy controls: Any neurological or psychiatric disorder Chronic pain Severe illness Pain treatment 3 days before the examination

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| T2D patients<br>600 type 2 diabetes (T2D) patients recruited from the DD2 cohort | |
| Gender- and age-matched healthy controls<br>100 healthy subjects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of diabetic polyneuropathy | For case definition of neuropathy, Tesfaye et al. 2010 will be used. | 5 hours | 
| Presence of painful diabetic polyneuropathy | Neuropathic pain grading system. Finnerup et al. 2016 will be used. | 5 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Type 2, Polyneuropathies, Diabetic
Evaluation of Early Retinal Vascular Modifications After Endoscopic Endonasal Pituitary Surgery

Study Overview
=================
Brief Summary
-----------------
This study evaluates the retinal vascular features using optical coherence tomography angiography in patients that received endoscopic endonasal approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.

Detailed Description
-----------------
To investigate the potential role of optical coherence tomography angiography in predicting the postoperative recovery of retinal vascular network of the optic disc in patients before and at 3 months after Endoscopic Endonasal Approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve. The optical coherence tomography angiography represents a novel and non-invasive diagnostic technique that allows a detailed analysis of retinal vascular features.

Official Title
-----------------
Early Retinal Vascular Modifications After Endoscopic Endonasal Pituitary Surgery: The Role of OCT- Angiography

Conditions
-----------------
Pituitary Adenoma

Intervention / Treatment
-----------------
* Procedure: Endoscopic Endonasal Pituitary Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age older than 45 years diagnosis of pituitary adenoma treatment-naïve with Endoscopic Endonasal Pituitary Surgery absence of other neurological diseases absence of vitreoretinal and vascular retinal diseases Exclusion Criteria: age younger than 45 years No diagnosis of pituitary adenoma previous treatments with Endoscopic Endonasal Pituitary Surgery presence of neurological diseases presence of vitreoretinal and vascular retinal diseases

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endoscopic Endonasal Pituitary Surgery|Surgical treatment consisted of an endoscopic endonasal approach using a rigid 0-degree endoscope, 18 cm in length and 4 mm in diameter.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of vessel density of the optic disc in patients underwent Endoscopic Endonasal Pituitary Surgery for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve. | To evaluate the role of optical coherence tomography angiography in predicting the recovery of the vessel density of the optic disc after surgery, using optical coherence tomography angiography (OCTA). The parameter analyzed by OCTA was the vessel density of the optic disc (percent) | 48 hours |
Perspectives on Bone Marrow Donors Who Donate for Their Parent

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to explore the role of family function on decision-making for bone marrow donors who donated for their parent, and to assess the unique supportive care needs of these participants. Semi-structured interviews were conducted with participants to identify overarching themes of the donation experience.

Official Title
-----------------
Perspectives on the Adolescent, Young Adult, and Adult Experience as Donors for Their Parent Undergoing Haploidentical Bone Marrow Transplants

Conditions
-----------------
Bone Marrow Transplant

Intervention / Treatment
-----------------
* Other: Semi-structured Interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Donated bone marrow or peripheral blood stem cells for their parent in the past 1-6 months Willing to participate in mandatory audio recorded telephone interview Able to participate in interview without assistance Must be English speaking Transplant recipient (parent) must be living Exclusion Criteria: Unable to provide oral consent for participation (for minors- unable to obtain parental consent and/or oral assent from child for participation)

Ages Eligible for Study
-----------------
Minimum Age: 13 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 |
| --- | --- |
| bone marrow/blood stem cell donors<br>Participants underwent a one time semi-structured telephone interview to understand the perspectives of bone marrow/stem cell donors experience, including how family dynamics impacted participants' decision to donate and identifying unique supportive care needs of bone marrow/stem cell donors. | Other: Semi-structured Interview<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Themes influencing donors' decision-making as assessed by words used during interview responses | Words/terms are extracted from interviewer responses and associated to key themes that influence participant's decision-making process. A codebook is used to reference these words/terms | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone marrow, stem cell, donor, interview
Autologous Adipose-Derived Stem Cell Transplantation in Patients With Lipodystrophy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the safety of the autologous transplantation of adipose-derived stem cells in the treatment of lipodystrophies.

Official Title
-----------------
Phase 1 Study of Autologous-Derived Stem Cell Transplantation in Patients With Lipodystrophy

Conditions
-----------------
Lipodystrophy

Intervention / Treatment
-----------------
* Procedure: autologous transplantation of liposuction material enriched with adipose-derived stem cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lipodystrophies with necessity of fat grafting accept to participate of the study Exclusion Criteria: HIV infection Metastatic malignancy Body mass index < 20 kg/m² Other severe systemic disease

Ages Eligible for Study
-----------------
Minimum Age: 20 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

| Intervention/Treatment |
| --- |
|Procedure: autologous transplantation of liposuction material enriched with adipose-derived stem cells|Lipoinjection enriched with adipose-derived stem-cells.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evaluation of the transplanted area. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of neovascularization, adipose transplantation reabsorption, tissue viability |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adipose-derived stem cell, Lipodystrophy
Reproducibility of Glucose Fluctuations by Standardized Exercise for Patients With Type 1 Diabetes - a Method Study Based on Continuous Glucose Monitoring

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to investigate whether the glucose response in type 1 diabetes patients measured using Continuous Glucose Monitoring measurement is reproducible in repeated standardized test sessions that include physical activity.

Official Title
-----------------
Reproducibility of Glucose Fluctuations by Standardized Exercise for Patients With Type 1 Diabetes - a Method Study Based on Continuous Glucose Monitoring

Conditions
-----------------
Diabetes Mellitus, Type 1, Exercise, Continuous Glucose Monitoring

Intervention / Treatment
-----------------
* Behavioral: Blood glucose measured using CGM during standardized physical activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes with a diabetes duration of at least 2 years age 18-60 years (inclusive) given informed consent exercises (at least 30 minutes intentional exercise where participants feel exhausted) one or more times a week participants agree to use CGM correctly Exclusion Criteria: pregnancy exercising at a high level (five or more times a week with high intensity) treatment with prednisolone or less than a month ago contestant has been treated with prednisolone treatment with beta blockers Abuse of alcohol / drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Blood glucose measured using CGM during standardized physical activity|Standardized exercise on bicycle at 70% of the participants work capacity for ½ hour.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose response measured with CGM | The participants will be tested on the research facility on a hospital in Denmark | 3 identical testing sessions throughout 3 weeks |
Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction

Study Overview
=================
Brief Summary
-----------------
The main goal of this study is to compare the use of Avanafil versus Sildenafil in spinal cord injury erectile dysfunction. The study has the characteristics of a non- inferiority, randomized, crossover, open clinical trial. The principal variable is the IIEF-EF (Erectile Function Domain questionnaire of the International Index of Erectile Function IIEF). This is an interventional study

Official Title
-----------------
Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction: Non- Inferiority, Randomized, Crossover, Open Clinical Trial

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Avanafil
* Drug: Sildenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spinal cord injury Erectile dysfunction No Medical Contraindication to use Avanafil and/or Sildenafil Able to provide informed consent Able to complete questionnaires Exclusion Criteria: Medical Contraindication to use Avanafil and/or Sildenafil No spinal cord injury Congenital spinal cord injury Not able to provide informed consent Not able to complete questionnaires

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: non- inferiority, randomized, crossover, open clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Avanafil<br>Clinical evaluation of the two pharmacological interventions (Sildenafil vs Avanafil). | Drug: Avanafil<br>* Drug administration (Avanafil)<br>* Other names: no other interventions;|
| Active Comparator: Sildenafil<br>Clinical evaluation of the two pharmacological interventions (Sildenafil vs Avanafil) | Drug: Sildenafil<br>* Drug administration (Sildenafil)<br>* Other names: no other interventions;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IIEF-EF | Erectile Function Domain questionnaire of the International Index of Erectile Function. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SLQQ-Part II | Sexual life quality Questionnaire | 2 years | 
| GAQ | Global Impression of efficacy | 2 years |