linjc16/ctgov huggingface dataset:
Effect of Renal Impairment on the Pharmacokinetics of NN9535

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). The aim of this clinical trial is to investigate how different degrees of renal impairment (mild, moderate, severe and end-stage renal disease) affect the pharmacokinetics of NN9535.

Official Title
-----------------
An Open-label Trial Investigating the Pharmacokinetics and the Tolerability of NN9535 in Subjects With Normal Renal Function and Various Degrees of Impaired Renal Function

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2, Renal Impairment

Intervention / Treatment
-----------------
* Drug: semaglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject) Subjects meeting the pre-defined GFR (glomerular filtration rate) criteria (estimated by the Cockcroft & Gault formula) for any of the renal function groups Body Mass Index (BMI) equal to or less than 40kg/m2 Exclusion Criteria: Known or suspected allergy to trial product(s) or related products Renal transplanted patients Certain cardiac problems (heart failure, unstable angina, MI (myocardial infarction) within the last 3 months) Known current hepatic dysfunction or severe hepatic disease during the last 12 months Female of childbearing potential/breast feeding History of alcoholism or drug abuse Blood donation during the last 8 weeks prior to the study Past or current history of pancreatitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: semaglutide<br>* 10 mg/mL of semaglutide solution for s.c. injection, single dose<br>* Other names: NN9535;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of NN9535 |  | at 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory safety, adverse events |  | at 21 days |
Teaching First Aid and Trauma Management to School Students

Study Overview
=================
Brief Summary
-----------------
This proposal aims to describe research that will utilize first aid in primary education students and will attempt to identify the frequency with which the training should be repeated and the type of trainer who will carry out the training program.

Detailed Description
-----------------
The training concerns courses with theoretical knowledge and practical skills related to first aid. Taking into account children's cognitive and psychological development, students will be trained in the following topics: calling an ambulance, managing bleeding, handling an unconscious patient, drowning, and managing a head injury. Classroom teachers and specialized staff will teach classes. The evaluation of knowledge and skills will be done with a questionnaire. The evaluation will take place before and immediately after the training, two months and seven months after the training.

Official Title
-----------------
The Importance of Teaching First Aid and Trauma Management to Primary School Students

Conditions
-----------------
Trauma-related Wound, Head Injury, Choking, Nose Bleed, Child, Only, Emergencies

Intervention / Treatment
-----------------
* Other: First aid lessons


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Students at primary schools and kindergarten, 4-9 years old Exclusion Criteria: Students over 9 years old

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 9 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No first aid training<br> | |
| Experimental: First aid training<br> | Other: First aid lessons<br>* The school children will have first aid training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that know first aid | We will use questionnaire to assess this outcome | 1 day pre the training | 
| Number of participants that learnt first aid | We will use questionnaire to assess this outcome | 1-day post the training | 
| Comparing the results of the training about the facilitators' performance | We will use questionnaire to assess this outcome | 2 months post the training | 
| Number of participants that retain the first aid knowledge | We will use questionnaire to assess this outcome | 7 months post the training | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
first aid training, children
Randomized Study on Endometrioma Treatment

Study Overview
=================
Brief Summary
-----------------
This is a randomised study comparing the effect of two laparoscopic techniques for treatment of ovarian endometriomas on recurrence rate and ovarian reserve.

Conditions
-----------------
Ovarian Endometrioma

Intervention / Treatment
-----------------
* Procedure: Laser treatment of ovarian endometrioma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18 and 40 years uni or bilateral symptomatic endometriotic cysts with a minimum diameter of 30 millimetres no counter-indication for the use of GnRH analogues Exclusion Criteria: previous pelvic surgeries history of cancer suspected malignancy presurgical suspicion or evidence of deep endometriosis presurgical suspicion or evidence of premature ovarian failure use of oestrogen suppressive drugs in the preceding 6 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser treatment<br> | Procedure: Laser treatment of ovarian endometrioma<br>* Laser vaporization of ovarian endometrioma<br>|
| Active Comparator: Endometrioma cystectomy<br> | Procedure: Laser treatment of ovarian endometrioma<br>* Laser vaporization of ovarian endometrioma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Sri Lanka

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this non-interventional study is to evaluate the current status of diabetes management, control, and complications in diabetic subjects in Sri Lanka.

Official Title
-----------------
A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Sri Lanka

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Other: No treatment given


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People with type 2 diabetes mellitus (DM) who are being treated, with any of the non-pharmacological or pharmacological options, at a particular centre for at least 1 year and who have visited the centre within the last 3-6 months Patients willing to sign informed consent form Exclusion Criteria: Previous participation in this study Unable to comply with protocol requirements Confirmed or suspected pregnancy

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 |
| --- | --- |
| Subjects with diabetes mellitus (type 2)<br> | Other: No treatment given<br>* Patients will fill out a questionnaire by interview.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients having HbA1c ((Glycosylated Haemoglobin) as measured during survey) less than 7% |  | Evaluated at the first visit (only one study visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Fasting Plasma Glucose (FPG) of patients |  | Evaluated at the first visit (only one study visit) | 
| Mean Postprandial Plasma Glucose (PPG) of patients |  | Evaluated at the first visit (only one study visit) | 
| Mean HbA1c of patients |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having dyslipidemia |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having hypertension |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having cardiovascular complications |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having peripheral vascular disease |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having diabetic nephropathy |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having diabetic eye complications |  | Evaluated at the first visit (only one study visit) |
Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the efficacy of Seprafilm in reducing the incidence of bowel obstruction and to evaluate the incidence of all serious adverse events (SAEs) associated with the use of Seprafilm occurring within 30 days postoperatively, and the incidence of abdominopelvic abscess within 6 months postoperatively.

Official Title
-----------------
A Prospective, Randomized, Multicenter, Controlled Evaluation of the Efficacy and Safety of Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery

Conditions
-----------------
Intestinal Obstruction, Digestive System Surgical Procedures

Intervention / Treatment
-----------------
* Device: Seprafilm Bioresorbable Membrane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were undergoing colon and/or rectal resections and/or adhesiolysis for treatment of bowel obstruction Exclusion Criteria: Patients with any medical condition or disease where 5-year survival was not expected Patients undergoing laparoscopy Patients undergoing surgery for treatment of acute abdominal trauma Patients with an abscess (abdominal or pelvic) present during the initial surgery Patients with a history of pulmonary embolus or deep vein thrombosis (DVT) within 1 year of surgery

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Seprafilm Bioresorbable Membrane|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients undergoing a variety of abdominal surgical procedures
Growth Hormone in a Patient With a Dominant-Negative GHR Mutation

Study Overview
=================
Brief Summary
-----------------
This is a prospective interventional study designed for a single patient with a dominant-negative mutation in the growth hormone receptor gene (GHR) which results in increased levels of growth hormone binding protein (GHBP). The patient will receive escalating doses of growth hormone titrated to achieve an insulin like growth factor-1 level above the mean and then growth response to therapy will be monitored.

Official Title
-----------------
Growth Hormone in a Patient With a Dominant-Negative GHR Mutation

Conditions
-----------------
Growth Disorders

Intervention / Treatment
-----------------
* Drug: Somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Be the specific subject with the a specific mutation in GHR leading to high GHBP. Exclusion Criteria: There are no exclusion criteria for this study.

Ages Eligible for Study
-----------------
Minimum Age: 9 Years

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

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: Growth hormone<br>The participant will receive escalating dose of growth hormone until an IGF-1 level is maintained between the mean and +2 standard deviations. | Drug: Somatropin<br>* Daily growth hormone at a starting dose of 50 mcg/kg/day and escalating<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth hormone dose | Dose of growth hormone required in mg/kg/day to achieve an IGF-1 level above the mean | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth Velocity | Growth velocity during 1st year of growth hormone treatment | 1 year | 
| Height standard deviation | Change in height standard deviation over the course of the 1st year of treatment with growth hormone | 1 year |
Radiation Therapy or Surgery in Treating Patients With Previously Untreated Vulva Cancer With Positive Groin Lymph Nodes

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Patient abstract not available PURPOSE: Patient abstract not available

Detailed Description
-----------------
OBJECTIVES: I. Compare the efficacy of pelvic node resection vs. bilateral groin and pelvic node irradiation for invasive squamous cell carcinoma of the vulva in patients having positive groin nodes. OUTLINE: Randomized study. Arm I: Surgery. Deep pelvic node dissection on sides containing positive nodes only. Arm II: Radiotherapy. Megavoltage (1 MeV or greater) to bilateral groin and pelvic nodes. PROJECTED ACCRUAL: Anticipated annual accrual is approximately 200 patients, with an active phase estimated at 2.5-3 years. Protocol closed July 1984.

Official Title
-----------------
Phase III Radiation Therapy vs Pelvic Node Resection for Previously Untreated Invasive Squamous Cell Carcinoma of the Vulva With Positive Groin Nodes

Conditions
-----------------
Vulvar Cancer

Intervention / Treatment
-----------------
* Procedure: regional lymph node dissection
* Radiation: radiation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: See General Eligibility Criteria PATIENT CHARACTERISTICS: See General Eligibility Criteria
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: regional lymph node dissection|nan|
|Radiation: radiation therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate |  |  | 
| Survival rate |  |  | 
| Subjective status on GOG performance scale |  |  | 
| Time to recurrence |  |  | 
| Survival time |  |  | 
| Morbidity of treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage III vulvar cancer, squamous cell carcinoma of the vulva
Costimulatory Molecules as Biomarkers in Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the expression of a certain class of molecules, called costimulatory molecules, in humans with Cystic Fibrosis. Cystic Fibrosis is a genetic disorder which renders the lung susceptible to persistent inflammation which, at times, can worsen, resulting in accelerated decline in lung function and eventually death or transplant. Our goal is to determine if the levels of costimulatory markers can be used to predict exacerbation and subsequent lung function decline in subjects with Cystic Fibrosis.

Official Title
-----------------
Costimulatory Molecules as Biomarkers in Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willingness to participate Exclusion Criteria: Presence of HIV Presence of Lymphoma/Leukemia Presence of Lung or other solid organ Transplant Pregnancy

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 |
| --- | --- |
| Adult Cystic Fibrosis Patients<br>Adults with Cystic Fibrosis will be followed longitudinally for 2 years | |

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
-----------------
Costimulatory molecules, Cystic Fibrosis, Biomarkers
Interstitial Lung Disease Trajectories in Patients With Systemic Sclerosis

Study Overview
=================
Brief Summary
-----------------
Systemic sclerosis (SSc) is a heterogeneous systemic autoimmune disease with distinct prognosis according to patients. In patients with systemic sclerosis, interstitial lung disease (ILD) concerns almost 50 % of patients and represents the main cause of mortality. Disease course in SSc-ILD is highly variable: patients can experience stable disease, slow or fast progression. Prevention of ILD progression now represents a key objective of SSc-ILD management. The understanding of the course and patterns of SSc-ILD progression is necessary, as reliable prediction tools that allow the stratification of the risk of progression. We aimed to identify the longitudinal trajectories of ILD in SSc patients using latent class mixed models and to examine their associations with SSc characteristics.

Official Title
-----------------
Evaluation of Interstitial Lung Disease Trajectories in Patients With Systemic Sclerosis (SCLEROPIDEVOL Study)

Conditions
-----------------
Systemic Sclerosis, Interstitial Lung Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with systemic sclerosis according to 2013 ACR/EULAR criteria Patients with interstitial lung disease on HRCT chest Patients with PFT at ILD diagnosis and at least 1 PFT evaluation during follow-up Exclusion Criteria: Patients with an alternative diagnosis of SSc-associated ILD (silicosis, sarcoidosis, lung cancer or other significant lung abnormalities)

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 |
| --- | --- |
| SSc-ILD patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FVC change over time | evaluation of %predicted FVC values over time using latent class mixed models (LCMM) | at ILD diagnosis (Day 0) and within 5 years after ILD diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DLCO change over time | evaluation of %predicted DLCO values over time using latent class mixed models (LCMM) | at ILD diagnosis (Day 0) and within 5 years after ILD diagnosis |