linjc16/ctgov huggingface dataset:
A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C

Study Overview
=================
Brief Summary
-----------------
This phase 3, open label study will evaluate the safety of tenapanor 50 mg BID in subjects with constipation-predominant irritable bowel syndrome (IBS-C) defined by the ROME III criteria. Subjects who have completed either TEN-01-301 (16 weeks) or TEN-01-302 (26 weeks) studies may be enrolled. Subjects will take tenapanor for approximately 52-55 weeks total based on previous protocol and this study.

Detailed Description
-----------------
During the treatment period of up to 39-weeks, subjects will return for study visits approximately every 13 weeks. Subjects will undergo safety assessments at these visits, which may include a physical exam, ECG, vital signs, and clinical labs. Adverse events and concomitant medications will be recorded. Medication compliance will be monitored and the subjects will be given additional study drug as appropriate.

Official Title
-----------------
An Open Label Long-Term Safety Study of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

Conditions
-----------------
Constipation Predominant Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: Tenapanor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects completed all 16 weeks of TEN-01-301 or all 26 weeks of TEN-01-302 Subject demonstrated adequate compliance with the study procedures during either the TEN-01-301 or TEN-01-302 studies Females must be of non-childbearing potential; If of child-bearing potential, must have negative pregnancy test and confirm the use of one of the appropriate means of contraception Males must agree to use appropriate methods of barrier contraception or have documented surgical sterilization Exclusion Criteria: Subject has been withdrawn or discontinued prematurely from either TEN-01-301 or TEN-01-302 The subject reports using any prohibited medication and is not willing to abide by the restrictions for intake Pregnant or lactating women

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50mg BID<br>Tenapanor, 50 mg BID (100 mg total) | Drug: Tenapanor<br> <br> * Other names: AZD1722;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events in >2% Patients | Safety assessments will be based on adverse events, clinical laboratory tests, vital signs, ECG, and physical exams | 52-55 weeks |
Single Patient Expanded Access Treatment Plan For The Investigational Product Narsoplimab

Study Overview
=================
Brief Summary
-----------------
The purpose of the EAP is to provide access to hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) patients who may benefit from treatment with narsoplimab based on the medical judgement of their respective physicians.

Official Title
-----------------
Single Patient Expanded Access Treatment Plan (EAP; Also Known As A Compassionate Use Plan) To Provide Patients Access To The Investigational Product Narsoplimab

Conditions
-----------------
Hematopoietic Stem Cell Transplant Associated Thrombotic Microangiopathy (HSCT-TMA)

Intervention / Treatment
-----------------
* Drug: Narsoplimab


Participation Criteria
=================
Eligibility Criteria
-----------------
Patient (adult or pediatric) must have undergone allogeneic or autologous hematopoietic stem cell transplant (HSCT) Patient must be capable of understanding an informed consent form (ICF) or the parent or legal guardian of the patient is able to understand and sign a written ICF prior to the initiation of any treatment procedures. Patient must have HSCT- TMA defined as having thrombocytopenia and evidence of microangiopathic hemolytic anemia.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Relation Between Near Point of Convergence and Postural Stability in Subjects With Non Specific Cervical Pain

Study Overview
=================
Brief Summary
-----------------
A correlation study was conducted to correlate between the convergence insufficiency and postural stability at three different cervical positions in patients with non-specific cervical pain.

Detailed Description
-----------------
A correlational study was conducted on eighty (male and female) subjects aged between 30-40 years old, presented with chronic NSCP persisted for six months or more, with neck disability index score (NDI) ≥10%, and can possess at least 45° of left and right cervical rotation participated in the study. Convergence insufficiency was evaluated by the near point of conversion (NPOC) rule and postural instability was examined by the Biodex balance system. RESULTS: There was significant positive correlation between (NPOC) and anteroposterior stability index (APSI) at the three cervical positions; neutral, 45° right torsion and 45° left torsion (P>0.05).

Official Title
-----------------
Relation Between Near Point of Convergence and Postural Stability in Subjects With Non Specific Cervical Pain

Conditions
-----------------
Neck Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age from 30 to 40 years, Chronic cervical pain ( 6 to18 months ago) Neck Disability Index (NDI) score ≥10%), Can possess at least 45° of cervical rotation to both the left and right. Exclusion Criteria: Neuromuscular or musculoskeletal disorders

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 40 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability index | Antero-posterior and mediolateral stability index | during the procedure | 
| The near point of convergence (NPOC) | The near point of convergence (NPOC) measured by NPOC rule | during the procedure | 
| The CROM | cervical flexion, extension, rotation and lateral flexion | during the procedure |
Change of Optic Nerve Sheath Diameter After Deflation of Pneumatic Tourniquet

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the change of the optic nerve sheath diameter after deflation of pneumatic tourniquet.

Detailed Description
-----------------
Deflation of pneumatic tourniquet could induces many changes in various organ systems. It has been shown to affect intracranial pressure. Thus, the investigators evaluate the change of optic nerve sheath diameter using ultrasound after deflation of pneumatic tourniquet in patients undergoing knee surgery.

Official Title
-----------------
Effect of Deflation of Pneumatic Tourniquet on the Change of Optic Nerve Sheath Diameter in Patients Undergoing Knee Surgery

Conditions
-----------------
Intracranial Pressure Increase

Intervention / Treatment
-----------------
* Procedure: Deflation of pneumatic tourniquet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status 1-4 patients undergoing knee surgery using pneumatic tourniquet Exclusion Criteria: patients who refuse to participate in this study patients with history of cerebrovascular disease patients who are judged ineligible by the medical staff to participate in the study for other reasons

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Deflation of pneumatic tourniquet|Deflation of pneumatic tourniquet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of optic nerve sheath diameter | difference in optic nerve sheath diameter measured using ultrasound before and after deflation of pneumatic tourniquet | 5 minutes before deflation and at 5-minute intervals for 10 minutes after deflation |
(MIGA) Mini Geriatric Assessment To Replace the Comprehensive Geriatric Assessment

Study Overview
=================
Brief Summary
-----------------
This is a comprehensive Geriatric Assessment (CGA) currently used to evaluate elderly people in order to be able to assess their multiple organ pathology, cognitive, functional and social problems. This CGA is a very time consuming tool although a powerful one. The investigators want to present a new assessment test witch is short and comprehensive tool witch will be checked in ambulatory and in-hospital geriatric patients.

Detailed Description
-----------------
MIGA test (Mini Geriatric Assessment) includes the following parameters Walking outdoors, Transfer, ADL-Dressing, Washing, Continence, Vision, Hearing, Pain, Sleeping, Weight loss, Get-Up-And-Go test, Short term memory, Clock drawing test, Falls, functional reach of hands, Depression, Behavioral problems, social support, Admissions, Polypharmacy, All patients will be assessed by the traditional CGA and by the new MIGA test. Time consuming of the two tests will be measured and compared.

Official Title
-----------------
(MIGA) Mini Geriatric Assessment as Compared to the Current CGA

Conditions
-----------------
Geriatric Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elderly people age 65 and above, In patients hospitalized in the geriatric department Out patients -from the geriatric out patient clinic Elderly patients visiting in the emergency room Exclusion criteria: People under 65 years old Critically ill patients ( acute infection, acute myocardial infarction, hypoxia, hemodynamic instability)

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Children With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Africa. The aim of this non-interventional study is to evaluate the current status of diabetes management, complications and psychosocial aspects for children with type 1 diabetes in Algeria.

Official Title
-----------------
Diabcare Paediatric - A Survey-study on Diabetes Management, Complications and Psychosocial Aspects of Type 1 Childhood Diabetics

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent obtained from the patient and his legal representative before any study-related activities (Study-related activities are any procedure related to recording of data according to the protocol) Type 1 diabetes Time since diabetes diagnosed at least 5 years Followed for diabetes at consultation for at least 12 months Exclusion Criteria: Patient previously included in this study Secondary diabetes Pregnant patient Patient consulting for an emergency

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| A<br> | Other: No treatment given<br>* Subject will fill out a questionnaire when entering the non-interventional study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean HbA1c (glycosylated haemoglobin) |  | At the first visit (only one study visit) after 12 month of follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients on insulin therapy |  | At the first visit (only one study visit) after 12 month of follow up | 
| Mean duration of insulin therapy |  | At the first visit (only one study visit) after 12 month of follow up | 
| Mean number of insulin injections/day |  | At the first visit (only one study visit) after 12 month of follow up | 
| Mean insulin units per day |  | At the first visit (only one study visit) after 12 month of follow up | 
| Percentage of patients on OAD or other treatments |  | At the first visit (only one study visit) after 12 month of follow up | 
| Percentage of patients having complications (ophthalmological, peripheral, renal and others) |  | At the first visit (only one study visit) after 12 month of follow up | 
| To quantify quality of life |  | At the first visit (only one study visit) after 12 month of follow up |
Twentyfour Ambulatory Pulse Wave Velocity and Central Augmentation Index in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The functionality and reproducibility of pulse wave analysis is investigated in 20 type 2 diabetic patients who had two 24 hour measurements performed within one week with the Arteriograph24 equipment.

Detailed Description
-----------------
Arteriograph24 is a new monitor for measuring ambulatory blood pressure and additional performing brachial cuff based on analysis of a suprasystolic pulse wave. The study aim to test the feasibility of ambulatory pulse wave analysis every twenty minute (the fraction of missed measurements)and the reprodicility of pulse wave velocity and central augmentation index in type 2 diabetic patients. In addition we will explore the relation between diurnal variation of brachial blood pressure, central blood pressure and pulse wave velocity. 20 type 2 diabetic patients will have 24h ambulatory blood pressure performed twice with an interval of one week.

Official Title
-----------------
Twentyfour Ambulatory Pulse Wave Velocity and Central Augmentation Index in Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Exclusion Criteria: Atrial fibrillation

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fraction of missed pulse wave analysis | Measurements of ambulatory blood pressure and pulse wave analysis is performed every twenty minute. The fraction of missed measurements of pulse wave analysis during day time and night time analysis is the final outcome | Meaured two times with an interval of one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reproducibility of pulse wave analysis parameters | Reproducibility of pulse wave velocity, Central systolic blood pressure and central augmentation index for 24 hour, day and night | Measured two times with an interval of one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulse wave analysis, pulse wave velocity, Arteriograph24, Ambulatory, diabetes, reproducibility, diurnal variation
A Scoring System for Difficult Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
Laparoscopic cholecystectomy is the treatment of choice for gall bladder stone disease. Difficult laparoscopic cholecystectomy (LC) is the most common difficult surgical procedure performed today, which possesses the potential to place the patient at significant operative risk.The aim of this study was to put a scoring system to avoid difficult laparoscopic cholecystectomy.

Detailed Description
-----------------
Patients with symptomatic chronic calculous cholecystitis based on clinical and radiological correlation undergoing elective laparoscopic cholecystectomy at Assiut University hospitals will be included for the study of 100 patients will operated by single experienced laparoscopic surgeon.The scores are given on history, clinical examination and radiological findings one day prior to surgery on admission.

Official Title
-----------------
A Scoring System for Laparoscopic Cholycystectomy to Pick up Difficult Cases

Conditions
-----------------
Cholecystitis, Chronic

Intervention / Treatment
-----------------
* Procedure: Laparoscopic Cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults male and female age of or above 18 years Symptomatic chronic calculous cholecystitis Ultrasound confirmed Gall bladder stones Exclusion Criteria: Complicated chronic calculous cholecystitis Malignant Gall bladder

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Scoring Factor<br>Intervention: Procedure: Laparoscopic cholecystectomy | Procedure: Laparoscopic Cholecystectomy<br>* Surgical removal of Gall bladder using laparoscopy<br>|
| Difficult criteria<br>Intervention: Procedure: Laparoscopic cholecystectomy | Procedure: Laparoscopic Cholecystectomy<br>* Surgical removal of Gall bladder using laparoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of preoperative scoring method for prediction of difficult laparoscopic cholecystectomy | Validation of sensitivity and specificity of Scoring system to predict difficulty of laparoscopic cholecystectomy | 1 year |
Risk Factors for Mortality in Cases of Obstructed Left Colonic Carcinoma

Study Overview
=================
Brief Summary
-----------------
seeking to identify risk factors leading to mortality in obstructed left cancer colon

Official Title
-----------------
Risk Factors for Mortality in Cases of Obstructed Left Colonic Carcinoma

Conditions
-----------------
Risk Factors for Mortality in Cases of Obstructed Left Colonic Carcinoma

Intervention / Treatment
-----------------
* Procedure: Resection
* Procedure: Stoma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged above 18 years admitted at Mansoura University Hospitals complaining from intestinal obstruction due to obstructed left sided carcinoma. Exclusion Criteria: Treatment with non-surgical intervention or spontaneous relief of obstruction

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stoma<br> | Procedure: Stoma<br>* Colostomy<br>|
| Active Comparator: Resection and stoma<br> | Procedure: Resection<br>* Left hemicolectomy<br>Procedure: Stoma<br>* Colostomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk Factors for Mortality in cases of obstructed left colonic Carcinoma | Predictors of mortality after surgery | 30 days after surgery |
Assessment of Blood Glucose Monitoring Systems

Study Overview
=================
Brief Summary
-----------------
System accuracy evaluation of different blood glucose monitoring systems with 3 lots of test strips per systems according to ISO 15197:2013

Official Title
-----------------
Leistungsbewertung Von Blutzuckermesssystemen im Methodenvergleich

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: Blood glucose monitoring systems


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Male or female subjects with type 1 or type 2 diabetes or healthy subjects For BG adjustment people with type 1 diabetes Exclusion Criteria: Severe acute illness that, in the opinion of the Investigator, might pose additional risk to the patient Chronic illness that, in the opinion of the Investigator, might pose additional risk to the patient Current condition that, in the opinion of the Investigator, doesn't enable subject to participate in the study For BG adjustment people with type 1 diabetes without CHD, condition after myocardial infarction, PAOD, cerebral events or hypoglycaemia unawareness Legal incompetence or limited legal competence Age < 18 years Dependency from the sponsor or the clinical investigator Mental incapacity or language barriers precluding adequate compliance with the study procedures

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 |
| --- |
|Device: Blood glucose monitoring systems|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of system accuracy |  | for each subject, the experimental phase has an expected duration of up to 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood glucose monitoring systems, ISO 15197, system accuracy