linjc16/ctgov huggingface dataset:
Taxotere (Docetaxel) in 1st Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare time to progression and overall survival after treatment with Taxotere plus cisplatin versus cisplatin plus 5-FU (PF treatment group) in the first line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

Official Title
-----------------
A Randomized Phase II-III Multicenter Trial of Docetaxel Plus Cisplatin and Docetaxel Plus 5-FU Versus Cisplatin Plus 5-FU in 1st Line Treatment of Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck.

Conditions
-----------------
Head and Neck Neoplasms, Neoplasm Recurrence, Local, Neoplasm Metastasis

Intervention / Treatment
-----------------
* Drug: docetaxel (XRP6976)
* Drug: cisplatin
* Drug: 5-fluorouracil (5-FU)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically or cytologically documented squamous cell carcinoma of the head and neck (SCCHN) (eligible primary sites: oral cavity, oropharynx, hypopharyx, or larynx) presenting with locally recurrent and/or metastatic disease, with at least 1 unidimensionally or bidimensionally measurable lesion.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: docetaxel plus cisplatin<br>Taxotere 75 mg/m², one-hour IV infusion on Day 1 of each 3-week cycle followed by cisplatin 75 mg/m² administered as a 30-minute to 3-hour infusion on Day 1 | Drug: docetaxel (XRP6976)<br> <br> * Other names: Taxotere;Drug: cisplatin<br> <br> |
| Active Comparator: cisplatin plus 5-FU<br>Cisplatin 100 mg/m², 30-minute to 3-hour infusion on Day 1 of each 3-week cycle followed by the continuous infusion of 5-FU 1000 mg/m²/day from Day 1 to Day 5 | Drug: cisplatin<br> <br> Drug: 5-fluorouracil (5-FU)<br> <br> |
| Experimental: docetaxel plus 5-FU<br>Taxotere 85 mg/m², one-hour IV infusion on Day 1 of each 3-week cycle followed by the continuous infusion of 5-FU 750 mg/m²/day from Day 1 to Day 5 Arm only in the phase II part of the study | Drug: docetaxel (XRP6976)<br> <br> * Other names: Taxotere;Drug: 5-fluorouracil (5-FU)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to progression |  | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival, overall response rate (complete response + partial response), duration of response, and time to treatment failure |  | up to 5 years |
Intravenous Fluids Versus Naso/Orogastric-tube Feeding in Hospitalized Infants With Bronchiolitis

Study Overview
=================
Brief Summary
-----------------
Oro- or nasogastric tube feeding is safe and may be more physiologic than intravenous (IV) fluids in hospitalized infants with acute viral bronchiolitis.

Official Title
-----------------
Intravenous Fluids vs. Naso/Orogastric-tube Feeding in Hospitalized Infants With Acute Viral Bronchiolitis: a Randomized, Controlled, Prospective Clinical Trial

Conditions
-----------------
Viral Bronchiolitis

Intervention / Treatment
-----------------
* Procedure: IV fluids
* Procedure: Naso/oro gastric tube feedings


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants with bronchiolitis < 6 months who need to be hospitalized and are not able to eat per os. Exclusion Criteria: Infants with severe bronchiolitis not allowed to get any gastric feeds or those that their parents will not sign an informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 6 Months

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV fluids<br>Infants will get IV fluids whem indicated until able to tolerate full oral feedings | Procedure: IV fluids<br>* Infants will be allocated to IV fluids<br>|
| Experimental: Oro/naso gastric tube feeding<br>Infants will get oro/naso gastric tube feeding whem indicated until able to tolerate full oral feedings | Procedure: Naso/oro gastric tube feedings<br>* Infants will be allocated to naso/oro gastric tube feedings<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes | Will compare clinical outcomes between the groups: Length of stay, need for oxygen, time to full feeds etc. | 3 winters | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Possible side effects of each method (IV vs. Oro/nasogastric feedings) | Local or systemic signs of infection, parainfusion, discomfort while inserting the IV, electrolyte abnormalitis (as part of routine care) vs. aspiration, discomfort with naso/oro gastric tube. | 3 winters |
Influence of Tracheostomy on Lung Deposition in Spontaneously Breathing Patient

Study Overview
=================
Brief Summary
-----------------
To compare lung deposition of amikacin in two settings: spontaneously breathing through a tracheostomy cannula and through the mouth.

Official Title
-----------------
Influence of Tracheostomy on Lung Deposition in Spontaneously Breathing Patient

Conditions
-----------------
Tracheostomized Patients

Intervention / Treatment
-----------------
* Other: Nebulization through the tracheostomy
* Other: Nebulization through the mouth


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who were likely to require an elective tracheostomy surgery as part as their head and neck surgery Exclusion Criteria: Allergy to Aminoglycosides Patients who received Aminoglycosides treatment less than one month prior the surgery Pectoralis major flap reconstruction Latissimus dorsi flap reconstruction

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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nebulization through the tracheostomy<br>Each subjects received two nebulization sessions. The first session was performed prior the tracheostomy removal (through the tracheostomy) and the second one when the when the tracheostome was totally scared (through the mouth) | Other: Nebulization through the tracheostomy<br>* Each subject received two nebulization sessions under spontaneous breathing in a sitting position. The first session was performed prior to tracheostomy removal. During the first nebulization, subjects inhaled the aerosol through the tracheostomy, cuff inflated and inner cannula removed.<br>|
| Active Comparator: Nebulization through the mouth<br>Each subjects received two nebulization sessions. The first session was performed prior the tracheostomy removal (through the tracheostomy) and the second one when the when the tracheostome was totally scared (through the mouth) | Other: Nebulization through the mouth<br>* Each subject received two nebulization sessions under spontaneous breathing in a sitting position. The second nebulization was performed when the tracheostome was totally scarred. During the second nebulization, subjects inhaled the aerosol a mouth piece and wore a nose clip.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amikacin urinary drug concentration |  | At each micturition during 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nebulization aerosol nebulizer tracheostomy
Measurement of Cerebral and Peripheric Tissue Oxygenation in Anemic Preterm Infants Who Underwent Blood Transfusion

Study Overview
=================
Brief Summary
-----------------
Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral oxygenation in newborn infants. Using this technique we investigated the relationship between changes in cerebral oxygenation and hemodynamics, and changes in some physiological variables during blood transfusion in anaemic preterm infants.

Official Title
-----------------
Measurement of Cerebral and Peripheric Tissue Oxygenation in Anemic Preterm Infants Who Underwent Blood Transfusion:A Near Infrared Spectroscopy Study.

Conditions
-----------------
Anemic Preterms, Cerebral Oxygenation,Somatic Oxygenation,Blood Transfusion

Intervention / Treatment
-----------------
* Device: near infrared spectroscopy: invos 5100
* Device: INVOS 5100
* Device: near infrared spectroscopy device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: <32 gestational age and/or <1500gr.,>30th day preterm infants - Exclusion Criteria:sepsis,shock,severe intracranial hemorrhage,NEC,abdominal and cranial surgery -

Ages Eligible for Study
-----------------
Minimum Age: 30 Days

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gest age, cerebral ,somatic oxygenation measurement<br> | Device: near infrared spectroscopy: invos 5100<br>* duration:six hours<br>Device: INVOS 5100<br>* NIRS device used in this study, the optical field includes a volume of tissue approximately 2 cm deep to the surface probe with a 4-mm source-detector distance, and thus, organ-specific monitoring is feasible in small patients. With informed consent, we applied NIRS probes to the forehead and the lower extremity for cerebral (rSO2C) and peripheric (rSO2P) regional oxygen saturation measurements.<br>Device: near infrared spectroscopy device<br>* NIRS device used in this study, the optical field includes a volume of tissue approximately 2 cm deep to the surface probe with a 4-mm source-detector distance, and thus, organ-specific monitoring is feasible in small patients. With informed consent, we applied NIRS probes to the forehead and the lower extremity for cerebral (rSO2C) and peripheric (rSO2P) regional oxygen saturation measurements.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral and peripheric oxygenation measurements in anemic preterm infants. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anemic preterms, cerebral oxygenation,somatic oxygenation, blood transfusion
Controlling and Lowering Blood Pressure With The MOBIUS HD™ (CALM-FIM_EUR)

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.

Detailed Description
-----------------
This is an open-label, multicenter, first-in-man clinical trial to be conducted in Europe. Eligible subjects with stage 2 resistant systemic arterial hypertension currently being treated with a minimum of three (3) anti-hypertensive drugs, who consent to study participation will be assigned to treatment with the MobiusHD system. Potential study participants will be consented and then screened at two (2) baseline visits beginning at least 30 days prior to MobiusHD placement. Qualified patients will undergo placement of the MobiusHD under angiographic visualization, and will then be followed for 36 months.

Official Title
-----------------
CALM-FIM_EUR - Controlling and Lowering Blood Pressure With the MobiusHD - A Prospective Multicenter Safety Study

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Device: MobiusHD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Office cuff SBP ≥ 160 mmHg measured per protocol instructions following at least one (1) month of maximally tolerated therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic unless patient has history of intolerance, ineffectiveness or contraindications. Exclusion Criteria: Known or clinically suspected baroreflex failure or autonomic neuropathy

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MobiusHD<br>MobiusHD | Device: MobiusHD<br>* Implant that is placed in the carotid sinus to control hypertension.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Serious Adverse Events (SAEs) | The number of participants with serious adverse events reported in the study will be tabulated. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Office Cuff Blood Pressure (BP) |  | Baseline, discharge (up to 2 days), 7 days, 1 month, 3 months, 6 months | 
| Mean 24-hour Systolic Ambulatory Blood Pressure (ABPM) at 6 Months |  | Baseline, 3 months, 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension
Acupuncture Treatment for Hot Flashes Study

Study Overview
=================
Brief Summary
-----------------
Patients with prostate cancer who are / were treated with hormonal treatment and developed hot flashes as a side effect are offered Acupuncture as an investigational intervention. The treatment is performed twice a week for four weeks, then once a week for the following six weeks

Detailed Description
-----------------
Patients with prostate cancer who are / were treated with hormonal treatment and developed hot flashes as a side effect are offered Acupuncture as an investigational intervention. The treatment is performed twice a week for four weeks, then once a week for the following six weeks. Acupuncture was done according to specific guidelines and mapping.

Official Title
-----------------
Acupuncture Treatment for Hot Flashes in Men With Prostate Cancer, A Phase I/II Study

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment for prostate cancer using hormonal ablation therapy Average of three or more hot flashes a day Performance Status (Karnofsky ≥ 60) Patients must be ≥ 18 years of age No other clinically significant disease Signed study-specific consent form prior to study entry Exclusion Criteria: Initiation of a new chemotherapy regimen, immunotherapy; or initiation/ cessation of hormonal therapy during the study or for 3 weeks before the start of the study Pharmacological treatment of hot flashes or use of selective serotonin reuptake inhibitors (unless the dose and patients' condition have been stable for 4 weeks) Skin infections Patients who had acupuncture treatment in the 6 weeks prior to entering the study, or acupuncture given specifically for the treatment of hot flashes in the previous 6 months.

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Acupuncture to pevent hot flushes
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>Acupuncture of the patients | Procedure: Acupuncture<br>* Patients will be have acupuncture (with electro stimulation)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief from the hot flashes as determined by the hot flashes scoring system. | A Questionnaire was given to the patients to determine the relief of hot flashes | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hot flashes, prostate cancer, acupuncture
A Multiple Ascending Dose Study of RO4998452 in Patients With Type 2 Diabetes Mellitus.

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Successive cohorts of patients will be randomized to receive either active drug, at escalating doses, or placebo. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Official Title
-----------------
A Randomized, Double-Blind, Multiple-Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO4998452 Following Oral Administrations in Patients With Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: RO4998452
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, 18-65 years of age; type 2 diabetes; either treated by diet and exercise alone or with metformin. Exclusion Criteria: type 1 diabetes mellitus; uncontrolled hypertension; clinically severe diabetic complications.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: RO4998452<br>* Escalating oral doses<br>Drug: placebo<br>* Oral doses<br>|
| Experimental: 2<br> | Drug: RO4998452<br>* Escalating oral doses<br>Drug: placebo<br>* Oral doses<br>|
| Experimental: 3<br> | Drug: RO4998452<br>* Escalating oral doses<br>Drug: placebo<br>* Oral doses<br>|
| Experimental: 4<br> | Drug: RO4998452<br>* Escalating oral doses<br>Drug: placebo<br>* Oral doses<br>|
| Experimental: 5<br> | Drug: RO4998452<br>* Escalating oral doses<br>Drug: placebo<br>* Oral doses<br>|
| Experimental: 6<br> | Drug: RO4998452<br>* Escalating oral doses<br>Drug: placebo<br>* Oral doses<br>|
| Experimental: 7<br> | Drug: RO4998452<br>* Escalating oral doses<br>Drug: placebo<br>* Oral doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs, laboratory parameters, vital signs. |  | Throughout study | 
| AUC0-24h, Cmax |  | Days 1 and 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parameters of glucose metabolism |  | Throughout study |
Oral Health Assessment of Children in CP Class

Study Overview
=================
Brief Summary
-----------------
Few oral exams are performed on 6-year-olds (key age for carious disease). This project aims to increase the number of oral check-ups for 6-year-olds in fragile areas (REP/REP+ areas).

Official Title
-----------------
Oral Health Assessment of Children in CP Class in REP/REP+ Areas in the Department of Hérault

Conditions
-----------------
Dental Caries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Be a first-grade student enrolled in a school in a zone REP/REP+ Have a parental permission Good understanding of the French language Exclusion criteria: - lack of parental permission

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 7 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 |
| --- | --- | --- |
| Presence of decay on each tooth present in the mouth | Presence of decay on each tooth present in the mouth | 1 day | 
| Presence of care on each tooth present in the mouth | Presence of care on each tooth present in the mouth | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oral hygiene, Public Health, Children, Prevention