linjc16/ctgov huggingface dataset:
Phase I Dose Finding Study of SSR97225 Given in Patients With Refractory Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the maximally tolerated dose and the dose limiting toxicity of this antimitotic, tubulin binding investigational drug for those patients who have failed standard anticancer treatments.

Official Title
-----------------
Phase I Dose Escalation and Pharmacokinetic Study of SSR97225 Administered as a 1 Hour IV Infusion D1 Every 3 Weeks (Arm A) or Administered as a 1hour IV Infusion D1, D8, D15 Every 3 Weeks (Arm B) in Patients With Refractory Solid Tumors

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: SSR97225


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of metastatic or locally advanced non-hematological cancer Patients with solid tumors refractory to therapy or for whom no therapy exists Exclusion Criteria: Five or more prior chemotherapy lines for metastatic disease Eastern Cooperative Oncology Group (ECOG) performance status >2 Patients having discontinued previous specific anti-cancer treatment Patients who have not recovered from all toxic effects from previous specific anti-cancer treatment (excluding alopecia) Patients with abnormal biological/hematological parameters, cardiac abnormalities or serious infection/intercurrent illness likely to jeopardize the patient's safety or the course of the protocol treatment No adequate birth control methods The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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 |
| --- | --- |
| Experimental: Arm A<br>1 hour IV infusion D1 | Drug: SSR97225<br>* every 3 weeks<br>|
| Experimental: Arm B<br>1 hour IV infusion D1, D8, D15 | Drug: SSR97225<br>* every 3 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal tolerated dose (MTD) and dose limiting toxicity (DLT) |  | Study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile, antitumor activity in patients with measurable disease, effect of drug on CYP3A4 activity |  | Study period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
solid tumor, antimitotic, tubulin binder
Knee Pain Phenotypes in the Community Study

Study Overview
=================
Brief Summary
-----------------
The focus of the study is to determine the prevalence and variance of self-reported knee pain characteristics in a community-derived sample of adults aged 40 years and over. It will also identify characteristics such as structural changes of osteoarthritis of the knee as well as physiological parameters and blood and urine biomarkers.

Detailed Description
-----------------
Number of participants: Part I: questionnaire to 40,000 people aged 40 years and over (giving an expected 10,000 respondents) Part II: 400 participants.

Official Title
-----------------
Knee Pain and Related Health in the Community Study

Conditions
-----------------
Knee Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Aged 40 years and over Exclusion criteria: Inability to give informed consent Terminal or mental illness Pregnant women

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Knee Pain Population<br>Participants who have responded to the questionnaire with self-reported pain. | |
| Non-Knee Pain Population<br>Participants who have responded to the questionnaire, no self-reported pain. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Pain Phenotypes | The prevalence of the different knee pain phenotypes, provided by specific pain questionnaires. This will include the Intermittent and Constant Osteoarthritis Pain Questionnaire (ICOAP), the Pain Catastrophizing Scale (PCS) and the PainDetect (for neuropathic pain). | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other Risk Factors | The risk factors for each knee pain phenotype, including age, gender, pain elsewhere, the Hospital Anxiety and Depression Scale (HADS), the pain catastrophizing scale and presence of osteoarthritis risk factors (BMI, finger ratio (2D4D), finger nodes, knee alignment) will be determined from the questionnaires. | up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee Osteoarthritis, Knee Pain, Community Study, Risk Factors
Study of the Impact of an Intervention Performed by a Clinical Pharmacist on Patients at Risk of Pneumococcal Infection at the End of Hospitalization

Study Overview
=================
Brief Summary
-----------------
In France, Streptococcus pneumoniae is the leading agent involved in community-acquired bacterial pneumopathies and bacterial meningitis. The frequency of these infections is increasing in at-risk subjects. Paradoxically, pneumococcal vaccination coverage in this type of patient is limited at the national level, even though the French High Council for Public Health (HCSP) has been extending the 13-valent conjugate and 23-valent non-conjugate double vaccination in this target population since March 2017. These patients generally benefit from regular medical follow-up involving several health professionals in hospital or outpatient clinics. In spite of this, one of the factors identified as a hindrance to pneumococcal vaccination is the absence of a proposal from the doctor. We would like to assess compliance with the recommendations for pneumococcal vaccination according to the High Council of Public Health (HCSP) in at-risk patients leaving hospital. We also wish to measure the potential impact of an intervention by the clinical pharmacist on the application of these recommendations.

Official Title
-----------------
Study of the Impact of an Intervention Performed by a Clinical Pharmacist on Patients at Risk of Pneumococcal Infection at the End of Hospitalization

Conditions
-----------------
Vaccination

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalization in one of the departments participating in the study At risk of pneumococcal infection according to HCSP recommendations (1) Negative pneumococcal vaccination status Adult patient (≥18 years old) Exclusion Criteria: Under safeguard of justice Unable to receive informed information Patient having objected to the use of their data.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| vaccine protocols dispensed by dispensing pharmacists. | number of vaccine protocols | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antipneumococcal
Analysis of Patient Seeking Second Opinion Who Are Undergoing Full Mouth Orthodontic Treatment

Study Overview
=================
Brief Summary
-----------------
Patient safety is a great concern for the whole society. Since the investigators have a leadership in the medical field in Taiwan, the investigators should be courageous to face the reality from the patients seeking second opinions undergoing orthodontic treatment. Orthodontics just became a recognized specialty by the Department of Health in Taiwan in 2009. It is just a beginning to set up the training course criteria at the national level. It will be a good timing for us to look at the treatment quality when patients seeking second opinions at NTUH. Whether the unsatisfied results are from the patient's unrealistic expectation, patient's compliance issue, doctor's diagnosis, treatment planning or skills, or a simple communication problem, depend on a good systemic analysis from the records and questionnaire collected in a timely fashion. The investigators plan to ask patients who are undergoing full-mouth orthodontic treatment and seeking second opinion to join this study. The investigators will thoroughly explain to patients before they agree to take records and fill in questionnaire. Then the investigators use these records to perform root cause analysis. Our hypothesis is that the risk of adverse event (AE) is related to the training quality, communication skills, patient's understanding and compliance. From these results, the investigators shall be able to assess the risk of AE and make the education policy either at continued education level or special training courses towards a patient satisfied treatment.

Official Title
-----------------
Analysis of Patient Seeking Second Opinion Who Undergoing Full Mouth Orthodontic Treatment

Conditions
-----------------
Malocclusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are not under full mouth fixed orthodontic treatment in National Taiwan University Hospital Exclusion Criteria: Patient who only had partial orthodontic treatment Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparison of GlideScope-Specific Rigid Stylet to Standard Malleable Stylet for GlideScope Intubation by Novice Operators

Study Overview
=================
Brief Summary
-----------------
Patients presenting for elective surgery requiring tracheal intubation will be randomized to one of two different endotracheal tube (ETT) stylets. The intubation will be done with a GlideScope videolaryngoscope by a novice operator. The primary outcome is time to intubation.

Official Title
-----------------
Comparison of GlideScope-Specific Rigid Stylet to Standard Malleable Stylet for GlideScope Intubation by Novice Operators

Conditions
-----------------
Airway

Intervention / Treatment
-----------------
* Device: GlideScope rigid stylet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any adult patient scheduled for elective surgery. ETT is indicated for the procedure in the opinion of the attending anesthesiologist. any operator who has performed ≤ 10 GlideScope intubations. Exclusion Criteria: any patient in whom the use of the GlideScope is contraindicated in the opinion of the attending anesthesiologist. Patient with known cervical spine abnormalities. any patients with known or probable difficult airways. (This rare occurrence is unlikely to be evenly distributed between the groups and could skew the data). any patient requiring rapid sequence induction.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rigid GlideScope Specific Stylet<br> | Device: GlideScope rigid stylet<br>* Patients will be intubated either with a rigid stylet meant to be used with the GlideScope, or with a standard malleable stylet used with other modalities of intubation.<br>|
| Active Comparator: 90º curvature, malleable stylet<br> | Device: GlideScope rigid stylet<br>* Patients will be intubated either with a rigid stylet meant to be used with the GlideScope, or with a standard malleable stylet used with other modalities of intubation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Intubation (Seconds) |  | 30-150 seconds (anticipated) |
CT-Based Versus Conventional Simulation for Palliative Radiotherapy of Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Radiotherapy (RT) treatment to the chest is a standard way of trying to decrease symptoms like cough or shortness of breath. Before any RT can be delivered, it must be planned, either using conventional x-rays (fluoroscopy) or using computer tomography (CT) scanning. This study is being done because the investigators do not know which of these two common ways of RT planning is better for balancing both treating the cancer and decreasing side effects.

Detailed Description
-----------------
Standard RT planning will be performed under conventional simulation, followed by CT-simulation (for study purposes only). Retrospectively, 3D treatment fields will be designed using the CT-simulation data, and compared to the actual treatment fields planned using x-rays. Coverage of the tumour volume will be assessed, together with doses, field sizes and beam positions, to determine relative undercoverage of tumour and overcoverage of normal tissue between the two planning methods, if any.

Official Title
-----------------
Comparison of Two-versus Three-Dimensional Treatment Planning for Patients Receiving Chest Radiotherapy for Symptom Control

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Procedure: CT- simulation scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with local symptoms secondary to histologically-confirmed non-small cell lung cancer Patients who will be receiving palliative-intent external beam radiotherapy Patients who are clinically appropriate for conventional radiotherapy planning Patients who can provide written informed consent Exclusion Criteria: Patients who cannot provide written informed consent

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Study Cohort | Procedure: CT- simulation scan<br>* Patients who are receiving standard palliative radiotherapy planned under x-rays will also undergo 1 CT-simulation scan which they would otherwise not require. The planning x-rays and CT scan will then be compared dosimetrically<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Palliative radiotherapy, Treatment planning, Non-small cell lung cancer
Evaluating Changes in Middle Ear Pressure Caused by CPAP

Study Overview
=================
Brief Summary
-----------------
This study is an investigation into the effect that CPAP has on the pressure in the middle ear. It will evaluate the middle ear pressure and ear drum appearance at multiple levels of CPAP pressure delivered via a full face mask. These measurements will be used to determine optimal levels of CPAP to affect individual's middle ear pressure, particularly those with negative middle ear pressure due to Eustachian tube dysfunction.

Official Title
-----------------
Evaluating Changes in Middle Ear Pressure Caused by CPAP

Conditions
-----------------
Eustachian Tube Disorder

Intervention / Treatment
-----------------
* Device: Continuous positive airway pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 No use of CPAP within past 30 days Individuals presenting to the UVA otolaryngology clinic who are otherwise healthy Exclusion Criteria: Pre-existing cardiopulmonary disease that presents a risk with CPAP use Inability to tolerate CPAP Recent otologic surgery

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

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

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

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: CPAP<br>All participants will be included in this arm, and CPAP will be administered using a full face mask at incrementally increasing pressures. This will occur during a single session lasting no more than one hour. | Device: Continuous positive airway pressure<br>* A CPAP machine will be used to deliver positive pressure at various levels after which middle ear pressure and ear drums will be evaluated for changes.<br>* Other names: CPAP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tympanometry | Probes in the ear canal evaluate middle ear pressure | 1 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective sensation | Patient reports if they felt their ears pop | 1 minute | 
| Subjective symptom score | A simple 7 question form regarding ear symptoms over the past month prior to trial involvement | 1 minute | 
| Otoscopy | An image of the ear drum is captured | 1 minute | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eustachian tube dysfunction, Audiometry
Assessment of Quality of Life and Satisfaction With Medical Care of Pediatric Type 1 Diabetes Mellitus Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the change score for the PedsQL short form Diabetes and Core Modules and the Patient Assessment of Chronic Illness Care measured at baseline (before changing care delivery models) and 12 months after transitioning to the team model of care delivery.

Detailed Description
-----------------
Pediatric Type 1 Diabetes Mellitus patients and their parents will complete the forms before and 12 months after the diabetes clinic at Children's Mercy Hospital in Kansas City, MO transitions to a team model of care delivery.

Official Title
-----------------
Assessment of Quality of Life and Satisfaction With Medical Care of Pediatric Type 1 Diabetes Mellitus Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 Diabetes Mellitus six years of age and older who are receiving care in the diabetic clinic at Children's Mercy Hospital Exclusion Criteria: T1 Diabetes Mellitus patients not receiving care in the diabetes clinic at Children's Mercy Hospital or not meeting the age requirements

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 1 Diabetes Mellitus, Quality of Life, Satisfaction of medical care delivery
Observe Abnormal Potential From the Offending Vessel to the Facial Muscles of HFS Patients

Study Overview
=================
Brief Summary
-----------------
The pathophysiologic basis of hemifacial spasm is cross-transmission between different branches of the facial nerve. The hypothesis is that the cross-transmission is mediated by the sympathetic nerve fibers on the surface of the offending artery. The abnormal potential from the offending vessel to the facial muscles will be detected on hemifacial spasm patients, so as to determine if the sympathetic nerve fibers take part in the circuit of cross-transmission.

Detailed Description
-----------------
It's hypothesized that at the location where the facial nerve is compressed by an artery, ephaptic cross-transmission takes place between the nude facial nerve fibers and the sympathetic nerve fibers on the arterial surface. Thus action potentials could spread indirectly from one facial nerve fiber to several other facial nerve fibers (via the bridge of sympathetic fibers), or directly from the sympathetic fibers to facial nerve fibers. The investigators assume this is the electrophysiological basis of hemifacial spasm and its characteristic sign abnormal muscle response (AMR). If an abnormal potential from the offending artery to the facial muscles similar to AMR can be recorded, the hypothesis will be verified.

Official Title
-----------------
Observation of the Abnormal Potential From the Offending Vessel to the Facial Muscles of Hemifacial Spasm Patients

Conditions
-----------------
Hemifacial Spasm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the age of 18-65 years old; with typical hemifacial spasm symptoms; with typical abnormal muscle response; preoperative magnetic resonance imaging revealed obvious paraneural artery; with informed consent. Exclusion Criteria: pregnant or lactating women; accompanied by other serious diseases, including liver, kidney, cardiovascular diseases; accompanied by mental illness or severe neurosis; unable to express the subjective symptoms.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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 |
| --- | --- | --- |
| Abnormal Potential From the Offending Vessel to the Facial Muscles |  | up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Latency from the root entry zone of facial nerve to the facial muscles |  | up to 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cross-transmission, offending vessel