linjc16/ctgov huggingface dataset:
Vapocoolant Analgesia for Breast Lymphoscintigraphy

Study Overview
=================
Brief Summary
-----------------
To learn if applying vapocoolant anesthetic spray (Nüm) on the surface of the intended injection site will reduce the pain/anxiety associated with breast injections.

Detailed Description
-----------------
Primary Objectives: Establish feasibility of topical vapocoolant in the setting of breast lymphoscintigraphy. Demonstrate safety of topical vapocoolant in the setting of breast lymphoscintigraphy. Secondary Objectives: To assess patient pain intensity associated with the performance of breast lymphoscintigraphy. To evaluate the attitude from patients about supporting the continued offering of topical vapocoolant in the breast lymphoscintigraphy clinic.

Official Title
-----------------
Vapocoolant Analgesia for Breast Lymphoscintigraphy

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: num Vapocoolant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any adult patient undergoing asubareolar breast lymphoscintigraphy injection will be eligible. Age ≥18 years old Ability to understand and the willingness to sign a written informed consent document. Childbearing potential, lactating, pregnant women will be included. Exclusion Criteria: Patients who have allergy or had prior hypersensitivity to either of the vapocoolants including 1,1,1,3,3 Pentafluoropropane and 1,1,1,2-Tetrafluoroethane. Patients with uncontrolled intercurrent illness (insulin dependent and non-insulin dependent diabetes) Patients with psychiatric illness/social situations that would limit compliance with study requirements.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: num Vapocoolant<br>vapocoolant anesthetic spray (a spray that cools and numbs the skin) to control pain during minor surgical procedures (such as lancing boils, incisions, injections and IV placements) and minor sport injuries | Other: num Vapocoolant<br>* Spray will be administered for 4 to 6 seconds from a distance of 3 to 6 inches to desired sites of skin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |  | through study completion; an average of 1 year. |
Vital Sign Monitor Device Validation - WARD

Study Overview
=================
Brief Summary
-----------------
Aim: to assess the validity of CE/FDA approved vital sign monitor devices for clinical use in clinical setting. Patients: up to 1000 medical and/or surgical patients will be included Intervention: Studies with various wirless or novel vital sign monitor devices control: Golden standard measurements or clinical standard devices Outcome: Agreement assessed by bias and limits of agreement between Intervention and control device.

Detailed Description
-----------------
Aim: to assess the validity of CE/FDA approved vital sign monitor devices for clinical use in clinical setting. Patients: up to 1000 medical and/or surgical patients will be included. Intervention: Studies with various wireless or novel vital sign monitor devices control: Golden standard measurements or clinical standard devices Outcome: Agreement assessed by bias and limits of agreement between Intervention and control device. Other statistical assessments of agreement may be chosen as secondary outcomes, dependent on the data-structure Setting: the study will be carried out in up to 76 hours with collection of vital sign data pre-, intra or postoperatively.

Official Title
-----------------
Vital Sign Monitor Device Validation - WARD

Conditions
-----------------
Surgery-Complications, Medical Complication

Intervention / Treatment
-----------------
* Device: novel vital sign monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
No inclusion or exclusion criteria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: novel vital sign monitor|Devices that are to be introduced into the clinic but where data from clinical relevant conditions such as complications are lacking to assess the validity under clinical conditions|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement between vital sign data from novel device and golden standard | agreement between novel device and golden standard or clinical standard devices, assess by bias and limits of agreement | 76 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of data from novel device and golden standard | descriptive statistics using parametric or non-parametric statistics where appropriate | 76 hours |
Voice Telerehabilitation

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to determine functional results of telerehabilitation (TR) in subjects affected by iatrogenic unilateral vocal fold paralysis (UVFP) during the COVID-19 pandemic outbreak. 40 patients with iatrogenic unilateral vocal fold paralysis underwent voice teletherapy with a synchronous approach. A multidimensional assessment by means of videolaryngostroboscopy, acoustic and perceptual analysis and patient self-assessment was carried out before, at the end of teletherapy and six months later.

Official Title
-----------------
Voice Telerehabilitation for Patients Affected by Iatrogenic Unilateral Vocal Fold Paralysis: From Necessity to Opportunity in the COVID-19 Time

Conditions
-----------------
Vocal Fold Palsy

Intervention / Treatment
-----------------
* Other: teletherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18-75 years onset of UVFP less than 1 month before internet access availability and ability to use a computer with an internal or external webcam. Exclusion Criteria: previous history of laryngeal pulmonary or gastric surgery current or previous pulmonary diseases hearing loss, neurological or motor deficits reading difficulties dysphagia unavailability of a computer and a webcam.

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: teletherapy|speech therapy remotely delivered|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analysis | to analyze the functional outcomes achieved by a group of patients with recent onset of iatrogenic UVFP who were referred to TR using a synchronous approach. | 1 month |
Comparison of Cervical Traction Versus Snag to Improve Pain and Quality of Life in Cervical Radiculopathy

Study Overview
=================
Brief Summary
-----------------
For the wellness by Comparing of Cervical Traction Versus Snag to reduce Pain and improve Quality of Life in Cervical Radiculopathy

Official Title
-----------------
Comparison of Cervical Traction Versus Snag to Improve Pain and Quality of Life in Cervical Radiculopathy

Conditions
-----------------
Quality of Life, Cervical Radiculopathy

Intervention / Treatment
-----------------
* Diagnostic Test: Cervical Traction
* Diagnostic Test: Snag


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females were included. Age group 20-50 years. Patient suffering with neck pain radiating down the arms. Patients with positive Spurling test, cervical distraction and upper limb tension test. Exclusion Criteria: Subject suffering with any systemic diseases of MSK. Patients already suffering with pain in shoulder and upper extremity which is of local origin. Patient with cardiovascular or respiratory disease. Patients having osteophytes in cervical vertebrae. Hypermobility of cervical region.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cervical Traction<br> | Diagnostic Test: Cervical Traction<br>* Cervical Traction to Improve Pain and Quality of Life in Cervical Radiculopathy<br>|
| Experimental: Snag Therapy<br> | Diagnostic Test: Snag<br>* Snag to Improve Pain and Quality of Life in Cervical Radiculopathy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale |  | 6 Months | 
| Quality of Life Scale QOL | QOL to improve Quality of Life in Cervical Radiculopathy | 6 Months |
Relevance of Isoniazid Dosage in Adults Treated for Tuberculosis

Study Overview
=================
Brief Summary
-----------------
Tuberculosis is the third leading infectious killer. In 2021, an estimated 10,6 million people fell ill with tuberculosis worldwide. Drug resistance emerges with the increase of antibiotherapy use. Among the four antimicrobial drugs used for tuberculosis, isoniazid is a first line treatment. It has a bactericidal activity against the tuberculosis complex. Nevertheless, the hepatic metabolism of isoniazid shows variation between individuals. There is a real risk of hepatotoxicity and neurotoxicity induced by isoniazid. The peak measurement (Cmax) of serum isoniazid is recommended to adjust the treatment and to allow recovery. Moreover, several samples allow a kinetics of isoniazid elimination so as to distinguish slow and fast acetylators. Few data are available on isoniazid acetylation. It could be useful to know the proportion of patients treated by isoniazid at a standard dose, associated with a risk of overdosing or underdosing. Inadequate exposures should be studied to understand if there is an impact in the medical care.

Official Title
-----------------
Relevance of Isoniazid Dosage in Adults Treated for Tuberculosis

Conditions
-----------------
Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: to be an adult, to have a diagnosis of tuberculosis Exclusion Criteria: pregnancy, disagreement to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| Serum isoniazid Cmax | : Serum isoniazid Cmax in the standards, (i.e., between 3 et 6 µg/ml measured at 1h or 2h). | between day 15 and day 30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Isoniazid, tuberculosis, acetylation
Incidence of Postoperative Residual Neuromuscular Blockade in the Era of Sugammadex

Study Overview
=================
Brief Summary
-----------------
This study is a prospective observational study. A total 52 patients will be included in this study. We will observe the incidence of postoperative residual neuromuscular blockade in patients receiving sugammadex.

Official Title
-----------------
Incidence of Postoperative Residual Neuromuscular Blockade in the Era of Sugammadex

Conditions
-----------------
Postoperative Residual Curarization

Intervention / Treatment
-----------------
* Drug: Sugammadex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing elective surgery under general anesthesia. American Society of Anesthesiologists grade 1, 2, or 3. Aged >18 years Exclusion Criteria: Refusal to participate in the study Body Mass Index < 18.5 kg/m2 or > 35 kg/m2 History of neuromuscular disease. History of allergy to neuromuscular blockade Scheduled to transfer to the intensive care unit

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sugammadex|At the end of surgery, neuromucular blockade will be reversed with 2mg/kg or 4mg/kg sugammadex depending on the depth of neuromuscular blockade.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative residual neuromuscular blockade | TOF ratio < 0.9 | On the arrival of PACU |
Comparison of Effects of TT With and Without Visual and Auditory Cues for Freezing & Gait Patients With PD

Study Overview
=================
Brief Summary
-----------------
To determine the comparison of effects of treadmill training with and without visual and auditory cues for freezing and gait in patients with Parkinson's disease

Official Title
-----------------
Comparison of Effects of Treadmill Training With and Without Visual and Auditory Cues for Freezing & Gait in Patients With Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Treadmill Training With Visual and Auditory Cues
* Diagnostic Test: Treadmill Training Without Visual and Auditory Cues


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who are clinically diagnosed with Parkinson Disease. Patients from both genders. Patients with age between 45 years and above. Patient with sufficient visual and auditory capacity to receive given cues will be included Exclusion Criteria: Patients with the history of neurological deficit other than PD. Patients who need assistance for walking will be excluded. Patient with any peripheral vascular disease will be excluded. Patient with history of lower limb fracture.

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treadmill Training With Visual and Auditory Cues<br> | Diagnostic Test: Treadmill Training With Visual and Auditory Cues<br>* Comparison of Effects of Treadmill Training With Visual and Auditory Cues<br>|
| Other: Treadmill Training Without Visual and Auditory Cues<br> | Diagnostic Test: Treadmill Training Without Visual and Auditory Cues<br>* Comparison of Effects of Treadmill Training Without Visual and Auditory Cues<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini Mental Examination Scale MME | MMS examination for Freezing and Gait in Patients With Parkinson's Disease | 6 Months. |
Effects of Body Structures and Function on Actıvıty and Partıcıpatıon in Patıents wıth Carpal Tunnel Syndrome

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to determine pain, sensation and electrodiagnostic findings in CTS; to examine its effects on activity and participation.

Detailed Description
-----------------
50 patients aged 20-55 years diagnosed with mild and moderate carpal tunnel syndrome according to AANEM will be included. VAS, LANSS, Boston Carpal Tunnel Questionnaire (Symptom Severity Scale - Functional Status Scale), Q-DASH, hand grip sensitivity measurement, hand pressure sensitivity measurement will be applied to the participants. In order to examine the relationship between body structure and functions (Pain, Sensation, EMG findings) and activity and participation with the AMOS program, the maximum likelihood method will be selected and a structural equation model (SEM) will be established.

Official Title
-----------------
Investigation of the Effects of Pain, Proprioception and Electrodiagnostic Findings on Activity and Participation in Patients With Idiopathic Carpal Tunnel Syndrome

Conditions
-----------------
Carpal Tunnel Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being diagnosed with mild-moderate CTS Being between the ages of 20-55 Volunteering to participate in the study Exclusion Criteria: Being diagnosed with severe CTS Have systemic inflammatory disease Having a disease that can cause polyneuropathy, such as diabetes mellitus Being receiving psychotherapy Illiteracy Have a hearing problem Have cognitive impairment Having a pacemaker

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 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 |
| --- | --- | --- |
| Leeds Assessment Neuropathic Symptoms and Signs (LANSS) | Leeds Assessment Neuropathic Symptoms and Signs (LANSS) scale is a clinical-based tool for identifying pain and patients with predominant neuropathic mechanisms. | 7 minutes | 
| Boston Carpal Tunnel Questionnaire | It is a questionnaire used to evaluate symptom severity and functional status in individuals with carpal tunnel syndrome. | 12 minutes | 
| Q-DASH | Q-DASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proprioception Assessment | Hand grip sensitivity will be measured with a dynamometer and hand pressure sensitivity will be measured with a Stabilizer Pressure Biofeedback (SBP) instrument. | 7 minutes | 
| Visual Analog Scale | Evaluates the severity of pain, scoring between 0-10. | 2 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Proprioception, Sensation, EMG, ICF
Provide Pre-approval Single-patient Expanded Access (Compassionate Use) of VYD222 for Patients With Symptomatic COVID-19 Refractory to Other Treatments

Study Overview
=================
Brief Summary
-----------------
Provide pre-approval single-patient Expanded Access (Compassionate Use) of VYD222 for patients with symptomatic COVID-19 refractory to other treatments.

Official Title
-----------------
Provide Pre-approval Single-patient Expanded Access (Compassionate Use) of VYD222 for Patients With Symptomatic COVID-19 Refractory to Other Treatments

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Drug: VYD222


Participation Criteria
=================
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: VYD222|Monoclonal antibody|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
System to Evaluate the Risk of Lymph Node Metastasis Preoperatively in Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
The lymph node status is difficult to be assessed preoperatively, this study aimed to develop a scoring system for predicting the risk of LNM in cervical cancer patients before operation.

Detailed Description
-----------------
Lymph nodes metastasis (LNM) was proved to be a critical risk factor related to the survival to cervical cancer survival. However, preoperative pelvic magnetic resonance imaging (MR) or computed tomography (CT) tests are less sensitive to assess the risk of lymph node metastasis. PET-CT is too expensive and radiative to be widely used in clinical practice. A model was constructed based on clinical indicators to predict lymph node metastasis preoperatively, providing a reference for clinical treatment.

Official Title
-----------------
Preoperative Scoring System to Predict the Risk of Lymph Node Metastasis in Cervical Cancer

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Procedure: surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of cervical cancer FIGO stage IB1-IIA1 Undergone radical hysterectomy with pelvic lymphadenectomy Peformed pelvic MRI examination preoperatively Exclusion Criteria: Had distant metastases diagnosed before or during the surgery Underwent neoadjuvant radiotherapy preoperatively Underwent neoadjuvant chemotherapy preoperatively Incomplete or inaccuratemedical records

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: surgery|Patients confirmed cervical cancer were undergone radical hysterectomy with pelvic lymphadenectomy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | death or loss of follow-up | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors influenced LNM | A multivariable logistic regression analysis was used to analysis the independent factors that contribute to LNM. | 60 months | 
| The accuracy of the model | The AUC curve was used to assess the discrimination of the scoring system. The comparison between predicted (mean ± SD) and observed rates of LNM was used to test the calibration. The Hosmer-Lemeshow test evaluated the model fit. | 60 months |