linjc16/ctgov huggingface dataset:
The Cranio-cervical Flexion Test Using the NOD Device

Study Overview
=================
Brief Summary
-----------------
to measure strength of the deep anterior neck muscles with a new measurement protocol and by using the NOD device, a dynamometer, in subjects with and without bruxism, and compared to EMG on the superficial muscles of the anterior neck and the masseter muscle.

Official Title
-----------------
The Cranio-cervical Flexion Test, Using the NOD. A Pilot and Feasibility Study

Conditions
-----------------
EMG, Muscle Strength, Neck Muscle Issue, Bruxism

Intervention / Treatment
-----------------
* Other: cranio-cervical flexion test with NOD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: with or without bruxism German fluent informend consent Exclusion Criteria: primary headache cranio-mandibulary disorders (CMD) in >3 months within the last 12 months current neck pain intensity > 2 out of 10 on Numeric rating scale known: neurological pathologies mental impairments or diseases pregnancy rheumatic disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bruxism<br>subjects with known bruxism, no TMD, primary headache or neck pain | Other: cranio-cervical flexion test with NOD<br>* testing the anterior neck muscles during a nodding movement and by using a dynamometer<br>|
| healthy<br>non-bruxism, no primary headache, TMD or neck pain | Other: cranio-cervical flexion test with NOD<br>* testing the anterior neck muscles during a nodding movement and by using a dynamometer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| activation score = AS | stepwise (5 steps) and correct (no substitution by the superficial muscles) activation of the deep neck flexors, that can be hold for 10 seconds: Each step increases by 3.4N. The scale will be offset, starting at 0N. Steps are accordingly: 3.4N, 6.8N, 10.2N, 13.6N, 17N. Higher scores denote better function | baseline | 
| performance index= PI | number of correctly performed 10 second holds at each incremental step. number between 1 and 10. Higher scores denote better function. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck-Pain | neck pain, headache or discomfort during or immediate after the test protocol, measured by a numeric rating scale from 0 to 10. Higher scores denote more pain or discomfort | baseline |
Mid- and Long-term Outcomes of Custom-made Aortic Devices

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate mid- and long-term outcomes after Thoracic endovascular aortic repair (TEVAR) with custom-made devices.

Official Title
-----------------
Results From a Multicenter Registry on the Outcomes of the Terumo Custom-made Aortic Endograft

Conditions
-----------------
Aortic Diseases, Thoracic Aortic Aneurysm

Intervention / Treatment
-----------------
* Device: Thoracic endovascular aortic repair (TEVAR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thoracic Aortic Disease Exclusion Criteria: Urgent/Emergent treatment

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

| Intervention/Treatment |
| --- |
|Device: Thoracic endovascular aortic repair (TEVAR)|The TEVAR procedure involves the placement of a covered stent (a metal mesh tube with a layer of fabric) into the weakened area of the artery.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Mortality | Any death occurring during follow-up | 3 years | 
| Aortic-related mortality | Any death occurring during follow-up and related to the procedure | 3 years |
Evaluation of Some Biochemical Markers of Bone Turnover in Childern and Adolescents With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
Type 1 diabetes is associated with many longterm complications as retinopathy,neuropathy and nephropathy. Recently, several studies have linked type 1 diabetes to bone fragility.Studies conducted on patients with type 1 diabetes have concluded that bone is negatively affected in type 1 diabetes with impaired bone density,increased fracture risk and impaired bone turnover markers.

Official Title
-----------------
Evaluation of Some Biochemical Markers of Bone Turnover in Childern and Adolescents With Type 1 Diabetes

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Diagnostic Test: serum ostecalcin,serum sclerostin and parathroid profile


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: childern and adolsecents below 16 years of age diagnsed with type 1 diabetes for at least 1 year age and sex-matched control childern and adolsecents will be included Exclusion Criteria: childern and adolescents with congenital bone disease, those with disorders of the parathyroid gland and those with chronic kidney disease.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 16 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 |
| --- | --- |
| cases group<br>childern and adolescents with type 1 diabetes | Diagnostic Test: serum ostecalcin,serum sclerostin and parathroid profile<br>* evaluation of bone turnover markers in blood<br>|
| control group<br>age and sex matched control childern and adolsecents | Diagnostic Test: serum ostecalcin,serum sclerostin and parathroid profile<br>* evaluation of bone turnover markers in blood<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of serum ostecalcin, sclerostin in patients with type 1 diabetes ann d their age and sex matched control | markers of bone turnover in patients with type 1 diabetes and their matched control | 12 months |
Burden of Respiratory Illnesses in Pediatric Intensive Care Unit and Its Outcome

Study Overview
=================
Brief Summary
-----------------
Acute respiratory infections (ARI) are an important cause of mortality and morbidity among children; one-fifths of under-five mortality being contributed by them (predominantly pneumonias ). About 11.9 million episodes of severe and 3.0 million episodes of very severe acute lower respiratory infections (ALRI) result in hospital admissions in young children worldwide. Respiratory infections and illnesses in children thus form a substantial disease burden in Pediatric intensive care unit. With this is mind, we studied clinical profile and risk factors contributing to mortality, and outcome of children with acute respiratory infections.

Official Title
-----------------
Burden of Respiratory Illnesses in Pediatric Intensive Care Unit and Its Outcome

Conditions
-----------------
Respiratory Illnesses

Intervention / Treatment
-----------------
* Diagnostic Test: Complete blood count (CBC), C reactive protein (CRP(., Chest x ray, ABG, Electrolytes, Random blood sugar, Creatinine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with pneumonia, bronchiolitis, bronchial asthma, chemical pneumonitis, cystic fibrosis and other respiratory diseases, Cardiorespiratory cases and Neurological cases with respiratory illness Exclusion Criteria: Post trauma case. Postoperative cases (developing respiratory complications during PICU stay).

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 12 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 |
| --- | --- |
| Respiratory Diseased children<br> | Diagnostic Test: Complete blood count (CBC), C reactive protein (CRP(., Chest x ray, ABG, Electrolytes, Random blood sugar, Creatinine<br>* I will use these investigations in my study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of respiratory illnesses | incidence of respiratory illnesses in PICU among other children | one year |
Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this is study is to evaluate the long-term safety of DCCR (diazoxide choline) extended-release tablets) in patients with Prader-Willi syndrome.

Official Title
-----------------
An Open-Label Study of DCCR (Diazoxide Choline) Extended-Release Tablets in Patients With Prader-Willi Syndrome

Conditions
-----------------
Prader-Willi Syndrome

Intervention / Treatment
-----------------
* Drug: DCCR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient); provide voluntary, written assent (subjects, as appropriate) Participant must: Have participated in and completed the Study C602 Randomized Withdrawal (RW) Period; Have participated in but discontinued from the Study C602 RW Period and at least 16 weeks have elapsed since the date of their randomization into the C602 RW Period; or Have participated in Study C602 OLE period, did not consent to participate in the RW Period, and at least 16 weeks have elapsed since the date of their C602 Open-Label Extension End of Treatment Visit. Exclusion Criteria: Positive urine pregnancy test (in females of child-bearing potential) Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 30 days after study participation. Participation in a clinical study of an investigational drug (including approved drugs for unapproved uses), investigational device, or therapeutic intervention subsequent to the C602 Open-Label Extension End of Treatment Visit.

Ages Eligible for Study
-----------------
Minimum Age: 4 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: DCCR<br>75 - 525 mg DCCR | Drug: DCCR<br>* Once daily oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of DCCR (adverse events. Safety analyses will be conducted in all subjects who receive at least one dose of DCCR in the C614 study. ( Adverse events) | Assess the safety of DCCR by evaluating the incidence and severity of adverse events. Safety analyses will be conducted in all subjects who receive at least one dose of DCCR in the C614 study. Adverse events will be described by type and level of severity. | Baseline to Week 262 or until resolution of certain adverse events |
Mental Coaching and Counseling for Bipolar Patients: Dealing With Moments of Crisis in Times of COVID-19.

Study Overview
=================
Brief Summary
-----------------
The goal of this interventional study is to evaluate some outcome parameters at the time of enrollment (T0), during the treatment (T1 and T2) and at the end (T3) of the subjects who will have carried out an individual counseling intervention or mental coaching. The aim is to determine the incidence of depression, trait anxiety, state anxiety, sleep disorders, resilience, defense mechanisms, distress caused by stressful events in a sample of subjects affected by Bipolar Disorder.

Official Title
-----------------
Mental Coaching and Counseling for Bipolar Patients: Dealing With Moments of Crisis in

Conditions
-----------------
To Determine the Incidence of Depression in Subjects Affected by Bipolar Disorder

Intervention / Treatment
-----------------
* Other: Counseling and Coaching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recruited subjects have a diagnosis of Bipolar Disorder and are 18 years of age or older. Exclusion Criteria: Previous or current intellectual disability in accordance with the Diagnostic and Statistical Manual of Mental Disorders, DSM-5. Patients who are unable to express consent and who do not have a caregiver who can give it for them.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with Bipolar Disorder<br> | Other: Counseling and Coaching<br>* Counseling is the art of helping yourself, that is, a helping relationship based on a series of interventions and stimuli for creativity, aimed at pursuing and maintaining an ever better relational, social and existential quality of life. Coaching is a fundamentally action-oriented method, aimed at concrete changes, the improvement of performance and the achievement of objectives.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the incidence of depression, trait anxiety, state anxiety, sleep disorders, resilience, defense mechanisms, distress caused by stressful events in a sample of subjects affected by Bipolar Disorder. | Administration of psychometric scales | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To ascertain the presence of evolutionary and maturational trends in the defensive structure especially in the face of a totally unpredictable and unexpected situation such as the COVID-19 pandemic. | Administration of psychometric scales | 12 months |
Patient Opinions Regarding General Anesthesia, Before and After Having Undergone a Procedure.

Study Overview
=================
Brief Summary
-----------------
The goal of this survey will be to assess the opinions and reticence of patients who have undergone surgical procedures that required the usage of general anesthesia both before they underwent the procedure and afterwards.

Official Title
-----------------
Patient Opinions Regarding General Anesthesia, Before and After Having Undergone a Procedure.

Conditions
-----------------
Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have experience with general anesthesia. Exclusion Criteria: Anyone who has not undergone a procedure using general anesthesia and who will not undergo such a procedure within the next 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| Perceived level of anxiety towards general anesthesia | The perceived level of anxiety (on a scale of 1 to 10) before and after undergoing general anesthesia | From exposure to general anesthesia until survey completion by September 2022 | 
| Perceived level of danger towards general anesthesia | The perceived level of danger (on a scale of 1 to 10) before and after undergoing general anesthesia | From exposure to general anesthesia until survey completion by September 2022 | 
| Perceived side effects of general anesthesia | Description of perceived side effects | From exposure to general anesthesia until survey completion by September 2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
General Anesthesia
Spine Trauma in the Elderly

Study Overview
=================
Brief Summary
-----------------
Our study aims at investigating short and long-term outcomes following surgery for subaxial spine injuries in the elderly (octogenarian) population.

Official Title
-----------------
Long-term Outcomes After Surgery for Subaxial Cervical Spine Injuries in Octogenarians, a Matched Controlled Analysis

Conditions
-----------------
Spine Injury, Trauma, Surgery

Intervention / Treatment
-----------------
* Procedure: Spine decompression and fixation surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients surgically treated for subaxial spine injuries between 2006 and 2018 Exclusion Criteria: Missing records
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Younger cohort (<80 years)<br> | Procedure: Spine decompression and fixation surgery<br>* Surgery is performed by either an anterior or posterior approach. Anterior approach is performed with either discectomy or corpectomy accompanied fusion, while the posterior approach consist in a bilateral laminectomy accompanied by fusion.<br>|
| octogenarians (≥80 years)<br> | Procedure: Spine decompression and fixation surgery<br>* Surgery is performed by either an anterior or posterior approach. Anterior approach is performed with either discectomy or corpectomy accompanied fusion, while the posterior approach consist in a bilateral laminectomy accompanied by fusion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | medical or surgical complications | 30-day postoperative period | 
| Mortality | death | End of the study period (or end of data collection) |
A Close Examination of Patient Experiences in Bipolar Disorder Clinical Trials

Study Overview
=================
Brief Summary
-----------------
Participation in clinical trials usually favors a particular demographic group. But there is limited research available to explain what study attributes affect the completion of these specific demographic groups. This study will investigate the safety and efficacy of bipolar disorder treatments. The focus will be on tracking the rates of completion and withdrawal among these individuals. It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future bipolar disorder study.

Official Title
-----------------
Investigating Factors Affecting Clinical Trial Participation Rates in Patients With Bipolar Disorder

Conditions
-----------------
Bipolar Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is at least 18 years of age Diagnosis of bipolar disorder Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: Women of childbearing potential without a negative pregnancy test; or women who are lactating. Has a serious medical or psychiatric illness likely to interfere with participation in this clinical study. Inability to perform regular electronic reporting

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Rate of bipolar disorder patients who decide to enroll in a clinical research. |  | 3 months | 
| Number of bipolar disorder study participants who remain in clinical research until completion. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar Disorder
Lung Overdistension and Abdominal Pressure Rise

Study Overview
=================
Brief Summary
-----------------
The goal of this pilot interventional no-profit study is to evaluate airway pressure, esophageal pressure and variations in lung volume distribution with EIT in mechanically ventilated patients admitted to our UTI with respiratory failure after the application of an abdominal weight and resulting increase of intra-abdominal pressure.

Official Title
-----------------
Lung Overdistension and Abdominal Pressure Rise: an EIT Based Pilot Study

Conditions
-----------------
Respiratory Failure, Respiratory Distress Syndrome, Adult

Intervention / Treatment
-----------------
* Procedure: Application of abdominal weight


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Invasive mechanical ventilation in acute respiratory failure (PaO2/FiO2 <300 mmHg) Need of PEEP trial Need of urinary catheter (used to measure IAP) Exclusion Criteria: Contraindication to EIT use Pacemaker or other metal device in thoracic region Contraindication to abdominal weight placement Surgical or traumatic incision on the abdomen Severe abdominal hypertension Esophageal diseases that counterindicate naso-gastric tube placement Severe hemodynamic instability (norepinephrine > 0.1 mcg/kg/min; dobutamine or dopamine > 5 mcg/kg/min; epinephrine every dosage) Severe obesity (BMI > 35 kg/m2) Need of > 7 kg weight to reach 5 mmHg IAP increase

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abdominal Pressure Rise<br>Application of an abdominal weight and record of respiratory mechanics data, intra-abdominal pressure variation, Electrical Impedance Tomography data | Procedure: Application of abdominal weight<br>* Application of variable weight on the abdomen to reach a 5 mmHg increase in IAP<br>* Other names: Intra abdominal pressure rise;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of lung volume distribution | TID % | through study completion, an average of 1 year | 
| Variation of airway pressure | cmH2O | through study completion, an average of 1 year | 
| Variation of esophageal pressure | cmH2O | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abdominal pressure, Overdistension