linjc16/ctgov huggingface dataset:
Study of an Expandable Interbody Device for the Lumbar Spine

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the safety and efficacy of CALIBER expandable spacer for the treatment of degenerative disc disease. Radiographic outcomes, intra-operative parameters, clinical outcomes, and patient satisfaction will be obtained from patients in this 2 year follow-up clinical study.

Detailed Description
-----------------
Patients will be followed-up at 3weeks, 6 weeks, 3 months, 6 months, 12 and 24 months with X-rays and questionnaires to determine their satisfaction, healing, fusion and return to work status

Official Title
-----------------
Efficacy and Safety of Expandable Spacer in the Treatment of Degenerative Disc Disease Using the Minimally Invasive Transforaminal Lumbar Interbody Fusion Surgical Approach

Conditions
-----------------
Degenerative Disc Disease

Intervention / Treatment
-----------------
* Device: CALIBER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DDD at 1 or 2 levels between L2 and S1 Between 18 and 80 years of age Unresponsiveness to documented non-surgical treatment modalities for a minimum of six months Ability to provide a signed Informed Consent Exclusion Criteria: Trauma at level(s) to be fused Previous documentation of osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated Immunosuppressive disorder History of substance abuse Any known allergy to a metal alloy

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?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Lumbar interbody cages
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CALIBER<br>1 or 2 levels of DDD between L2 and S1, treated with transforaminal interbody fusion | Device: CALIBER<br>* Expandable interbody spacer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion and Disc Height Maintenance | Inter-vertebral disc height in millimetres at 24 month follow up. | 24 months | 
| Fusion Assessment | An assessment of the fusion status of surgically treated spinal levels. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Self Assessment | Oswestry Disability Index. A 10 item questionnaire with responses scored 0 to 5 and then presented as a percentage score from 0 to 100, with higher scores denoting more disability. | Upto 24 mo | 
| Visual Analog Scale for Back Pain | A visual scale from 0 to 100 in which the patient responds with their pain level by marking on the line, higher as more severe pain. | 24 months |
Study Evaluating Single Doses of ILV-095 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerability of single doses of ILV-095 in healthy subjects.

Official Title
-----------------
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ILV-095 Administered Subcutaneously to Healthy Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Biological: ILV-095
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women of non-childbearing potential ages 18 to 50 years old. Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to50 kg. Healthy as determined by the investigator on the basis of screening evaluations. Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay. Have a high probability for compliance with and completion of the study. Exclusion Criteria: Presence or history of any disorder that may prevent the successful completion of the study. Any subject who had orthopedic surgery within 12 weeks of the screening visit or has planned (elective) orthopedic surgery within 12 weeks of study drug administration. Acute disease state (eg, nausea, vomiting, fever, active infection, or diarrhea) within 7 days before enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ILV-095<br>6 SC single dose injections | Biological: ILV-095<br> <br> |
| Placebo Comparator: Placebo<br>Placebo | Biological: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability will be evaluated from adverse events, physical examinations, vital sign measurements, cardiac rhythm monitoring, 12-lead ECGs, and clinical laboratory test results. |  | 3 weeks per group | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters |  | 3 weeks per group |
Pharmacokinetics of Drugs Administered to Children

Study Overview
=================
Brief Summary
-----------------
This is a prospective study of children <21 years of age with the goal of characterizing the PK of drugs administered per standard of care as prescribed by the treating caregiver.

Official Title
-----------------
Pharmacokinetics of Drugs Administered to Children Per Standard of Care

Conditions
-----------------
Pediatric ALL

Intervention / Treatment
-----------------
* Drug: Standard of care drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children (< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver Exclusion Criteria: Failure to obtain consent/assent (as indicated)

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 20 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Standard of care drug|This study is collecting PK data on children prescribed the following drugs of interest per standard of care: dexmedetomidine, bosentan, furosemide, chlorothiazide, ethacrynic acid, bumetanide, hydromorphone, tacrolimus, ampicillin, gentamicin, caffeine, fentanyl, midazolam, foscarnet, hydroxychloroquine, and moxifloxacin.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) |  | Data will be collected throughout the hospital or outpatient stay up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (Cmax) |  | Data will be collected throughout the hospital or outpatient stay up to 90 days | 
| Time to achieve maximum concentration (Tmax) |  | Data will be collected throughout the hospital or outpatient stay up to 90 days | 
| Absorption rate constant (ka) |  | Data will be collected throughout the hospital or outpatient stay up to 90 days | 
| Elimination rate constant (kel) |  | Data will be collected throughout the hospital or outpatient stay up to 90 days | 
| Half-life (t1/2) |  | Data will be collected throughout the hospital or outpatient stay up to 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetics
Examination Chair for Hip Internal Rotation Range of Motion Measurement

Study Overview
=================
Brief Summary
-----------------
Hip internal rotation range of motion (HIRROM) assessment is performed to assess the mobility of the hip. The assessment is typically done manually (manual testing), which induces large variability in the results between and within testers. An initial version of an examination chair (EC1) was recently developed with the aim to minimize the variability of testing results for HIRROM assessments. A new version of the examination chair (EC2) has been implemented in order to individualize the testing protocol and will be validated in this study.

Official Title
-----------------
Validation of a Test Protocol for Measuring the Hip Internal Rotation Range of Motion Using a Newly Developed Examination Chair

Conditions
-----------------
Limited Hip Mobility

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants are pain free in the lower extremity, hip and back Participants signed the consent form Exclusion Criteria: Participant requires pain relief medication History of hip surgery Neuromuscular disorders Legal incompetence

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Healthy participants<br> | Other: no intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip internal rotation range of motion angle (degrees) | Participants will be tested for hip internal range of motion using three different methods. The measurements will be repeated 7 days after the initial measurement. | 7 days |
Impact of Pulmonary Rehabilitation After Lung Resection for Cancer on Patients' Level of Anxiety and Depression

Study Overview
=================
Brief Summary
-----------------
The interest of pulmonary rehabilitation for patients who underwent lung resection for cancer remains controversial. The investigators studied the effects of the RR and its impact on quality of life and level of anxiety and depression in patients. In 2011 and 2012 , an RR was proposed to the patients referred to our center after lung resection for cancer. Patients were assessed at entry and departure by 6minutes walk test , a visual analog pain scale , a quality of life questionnaire ( EORTC QLQ C30 ) and an anxiety questionnaire and Depression (HAD) . These same questionnaires were mailed 6 months after the end of the pulmonary rehabilitation .

Official Title
-----------------
Impact of Pulmonary Rehabilitation After Lung Resection for Cancer on Patients' Level of Anxiety and Depression

Conditions
-----------------
Pulmonary Resection

Intervention / Treatment
-----------------
* Other: questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with pulmonary resection Patients undergoing a standardized approach (or thoratomie videothoracoscopy)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pulmonary resection<br> | Other: questionnaires<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of depression with scale | Assess the level of depression during and after a respiratory rehabilitation training in institutions | At 6 months | 
| level of anxiety withe scale | Assess the level of anxiety during and after a respiratory rehabilitation training in institutions | At 6 months |
Long Term Prophylactic Therapy of Congenital Long QT Syndrome Type III (LQT3) With Ranolazine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether ranolazine will reduce the risk of arrhythmic events in patients with long QT syndrome type 3.

Conditions
-----------------
Long QT Syndrome Type 3

Intervention / Treatment
-----------------
* Drug: Ranolazine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Long QT patients with genetic confirmation of carrier-status for the D1790G mutation in the SCN5A gene Corrected QT interval > 460 msec Exclusion Criteria: Need for therapy with medications that are potent or moderately potent CYP3A inhibitors (such as ketoconazole, diltiazem, verapamil, macrolide antibiotics or HIV protease inhibitors)

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ranolazine<br>Ranolazine 500-1000 mg twice a day as tolerated | Drug: Ranolazine<br> <br> * Other names: Ranexa;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with syncope and/or documented ventricular arrhythmia |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in corrected QT interval |  | within 30 days of initiation of Ranolazine treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Long QT syndrome, Ranolazine
Severe and Transient Hypoxemia During Selective Intra-arterial Chemotherapy for Retinoblastoma in Children: Evaluation of the Right-sided Heart Function.

Study Overview
=================
Brief Summary
-----------------
Children having selective ophthalmic artery chemotherapy for retinoblastoma under general anaesthesia may experience troubles during the procedure. The troubles are transient, may be severe and include hypoxemia, hypotension and bradycardia. All children having such trouble always fully recovered without any sequelae or prolonged length of stay. The investigators suspect that these phenomenons are caused by transient pulmonary hypertension.The objective is to see whether transient pulmonary hypertension and right-sided heart failure is present during theses phenomenon by trans-thoracic echocardiography.

Official Title
-----------------
Severe and Transient Hypoxemia During Selective Intra-arterial Chemotherapy for Retinoblastoma in Children: Evaluation of the Right-sided Heart Function.

Conditions
-----------------
Retinoblastoma

Intervention / Treatment
-----------------
* Diagnostic Test: Trans-thoracic echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Retinoblastoma requiring selective ophthalmic artery chemotherapy under general anaesthesia Exclusion Criteria: Obesity pre-existing significant heart or pulmonary disease.

Ages Eligible for Study
-----------------
Maximum Age: 6 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Trans-thoracic echocardiography|Trans-thoracic echocardiography|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of pulmonary hypertension and/or right-sided heart failure (systolic arterial pulmonary pressure and visual function of the right ventricle is measured) |  | Perioperative. |
Calcitriol Supplementation in COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
This is a randomized, open label study to evaluate the efficacy and safety of calcitriol supplementation in COVID-19 patients with vitamin D deficiency.

Detailed Description
-----------------
This is a randomized, open label study to evaluate the efficacy （clinical and laboratory change）and safety （serum calcium） of calcitriol supplementation in COVID-19 patients with vitamin D deficiency.

Official Title
-----------------
A Randomized Open Label Study to Evaluate Efficacy of Calcitriol Supplementation in COVID-19 Patients With Vitamin D Deficiency

Conditions
-----------------
COVID-19, Vitamin D Deficiency

Intervention / Treatment
-----------------
* Drug: Calcitriol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized symptomatic COVID-19 patients; COVID-19 nucleic acid Ct value < 28 (both orf1ab gene Ct value and N gene Ct value < 28); Vitamin D deficiency: 25OHD ≤ 20ng/ml; Age: 18-70 years old; Exclusion Criteria: Asymptomatic COVID-19 patients ； Hypercalcemia; History of primary hyperparathyroidism; History of triple hyperparathyroidism; Patients who are allergic to calcitriol; Pregnant or lactating women; Patients with severe heart or lung diseases or tumor history; Patients already taking vitamin D or its similar preparations; Participants in other interventional clinical studies (including taking paxlovid); Patients with renal insufficiency (eGFR<60ml/min/1.73m2); Patients considered unsuitable for this study by the investigator；

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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
Interventional Model Description: treatment group and control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>calcitriol 0.25ug daily for 10 days + COVID-19 routine treatment | Drug: Calcitriol<br>* Calcitriol supplementation orally<br>* Other names: Rocaltrol;|
| No Intervention: control group<br>COVID-19 routine treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cycle threshold (Ct) value of COVID-19 nucleic acid after treatment | Nucleic acid test of COVID-19 | The 6th day after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical symptoms changes | fever, cough, sore throat，etc | The 6th day after treatment | 
| Laboratory examination changes | Complete Blood Count， inflammatory markers ，cytokines | The 6th day after treatment |
Ninth Dorsal Osteopathic Visceral Manipulation D9

Study Overview
=================
Brief Summary
-----------------
The aims of this study is to verify that the vertebral manipulation of dorsal level D9 influences the pancreas biochemical and endocrinology blood values.

Detailed Description
-----------------
A longitudinal experimental study was conducted in which the osteopathic thrust maneuver was applied. In this research, 87 healthy subjects participated, of which 56.3% (n = 49) are men and 43.7% (n = 38) are women aged 19-29 who study at the Catholic University of Murcia.The blood analytical values of insulin and glycemia have been measured in 4 different times: at baseline, after 2,5 and 10 minutes of the technique application with the purpose to verify any possible change.

Official Title
-----------------
Ninth Dorsal Osteopathic Visceral Manipulation D9 Affects Pancreas Blood Levels

Conditions
-----------------
Osteopathia, Manipulation

Intervention / Treatment
-----------------
* Other: Manipulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: students between 18-27 years old healthy persons Acceptance of informed consent Exclusion Criteria: pancreatitis diabetes I,II type anemia Alcohol intake for 12 hours prior.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 27 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>The control group did not received any treatment | |
| Experimental: Manipulation<br>Experimental group received the osteopathic maneuver and the blood value were measured at baseline, after 2,5 and 10 minutes. | Other: Manipulation<br>* Thrust technique application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basal insulin laboratory value change | The normal values of basal insulin measured with the imunoanalysis method are ˂ at 25.0 mU / l. If these values are exceeded, the effect of the manipulation in the study is verified | 10 minutes | 
| Basal glycemia laboratory value change | The normal values of basal glycemia measured with the enzymatic method vary between 60 - 105 mg / dl. The change of these values according to the reference laboratory has been the basis of the study. | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thrust technique, Blood levels, Pancreas, Ninth vertebra, Manipulation