linjc16/ctgov huggingface dataset:
Modality of Pain Management in Ambulatory Tonsillectomy Surgery in Adults

Study Overview
=================
Brief Summary
-----------------
No SFORL recommendation for adult ambulatory tonsillectomy. This study would allow the establishment of an ambulatory management during an adult tonsillectomy. This would allow a return home from J0 for the patient and therefore would improve the comfort of the patients and reduce the cost associated with a conventional hospitalization over several days.

Official Title
-----------------
Modality of Pain Management in Ambulatory Tonsillectomy Surgery in Adults: External Pilot Study

Conditions
-----------------
Tonsillar Disorder

Intervention / Treatment
-----------------
* Other: Assess pain management modalities in adult outpatient tonsillectomy surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: programmed Tonsillectomy surgery Exclusion Criteria: Congenital or acquired hemostasis disorder Indication of uvulo-bike-pharyngo-plasty Contraindication to the use of one of the protocol molecules including pregnancy Allergy to analgesic treatments used in the study Ongoing analgesic treatment that cannot be interrupted

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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Assess pain management modalities in adult outpatient tonsillectomy surgery
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ambulatory protocol after adult tonsillectomy<br>prescription of analgesics for outpatient procedure with hospital surveillance | Other: Assess pain management modalities in adult outpatient tonsillectomy surgery<br>* use a post-operative analgesia protocol suitable for outpatient surgery. Namely a protocol of analgesia based on the taking of drugs per bone (by mouth) and not intravenous. Pain evaluation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess pain management modalities in ambulatory tonsillectomy surgery in adults through post-operative pain assessment, with a defined analgesia and anesthesia protocol adapted to ambulatory management. | Pain measured by self-assessment by Analog Visual Scale (0-10). If score is under 4 = efficacity of ansthesia protocol | 14 days |
Vitamin K-absorption From Dairy

Study Overview
=================
Brief Summary
-----------------
Lactic acid bacteria produce a mixture of higher menaquinones, including menaquinone-9 (MK-9) and menaquinone-10 (MK-10). Vitamin K1 (phylloquinone) is normally present in chloroplasts in green vegetables. A new dairy product is developed containing both vitamin K1 and K2-vitamins. However, the extent to which the various forms of vitamin K are absorbed from such a mixture is not known. In this study the absorption profile of phylloquinone and menaquinones from this new dairy product containing several K-vitamins is investigated. This study describes a dietary intervention experiment for one single cocktail containing several K-vitamins as part of a dairy product.

Official Title
-----------------
Absorption of Different Forms of Vitamin K From Dairy Products

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: vitamin K-rich dairy product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women between 20 and 45 years old Subjects of normal body weight and height according to BMI < 30 Subjects of Caucasian race Subject has given written consent to take part in the study Exclusion Criteria: Subjects with (a history of) metabolic or gastrointestinal disease Subjects presenting chronic degenerative and/or inflammatory disease Abuse of drugs and/or alcohol Subjects receiving corticoid treatment Subjects using oral anticoagulants

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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: vitamin K-rich dairy product<br>one single intake of a dairy product containing several K-vitamins: phylloquinone, menaquinone-7,8,9-and 10. | Dietary Supplement: vitamin K-rich dairy product<br>* several forms of vitamin K: phylloquinone, menaquinone-7,-8,-9,and -10.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum vitamin K levels: phylloquinone, menaquinone-7,-8,-9,and -10 |  | one single intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| distribution of vitamin K-forms over lipoprotein fractions: triglyceride rich lipoprotein (TGRLP), intermediate-density lipoprotein (IDL), low-density lipoprotein (LDL), high density lipoprotein (HDL) as well as the lipoprotein-free fraction (LPF) |  | one single intake | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin K, Bio-availability
Incidence and Patterns of Nausea/Vomiting With Combined Chemotherapy and Radiation

Study Overview
=================
Brief Summary
-----------------
Questionnaire study to observe the incidence and pattern or nausea and vomiting in patients receiving combined chemotherapy and radiation. 83% of patients experience radiation therapy-induced vomiting; significant nausea and vomiting could develop with concurrent chemotherapy despite standard anti-nauseous medication prophylaxis.

Detailed Description
-----------------
Questionnaires will be answered daily on a weekly basis during period of radiation and chemotherapy.

Official Title
-----------------
A Prospective Study to Evaluate the Incidence and Patterns of Nausea and Vomiting in Patients Receiving Combined Chemotherapy and Radiation

Conditions
-----------------
Cancer of the Head and Neck, Cancer of the Lung, Cancer of the Esophagus, Gastro-esophageal Junction Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Concurrent radiation and chemotherapy treatment Aerodigestive malignancy Exclusion Criteria: Other causes of vomiting (i.e.gastrointestinal obstruction...)

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 |
| --- | --- |
| Observation<br>Adult patients receiving both radiation therapy and chemotherapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess incidence and patterns of nausea and vomiting in patients undergoing concurrent chemotherapy and radiation |  | week of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the impact of nausea and vomiting on the patients' daily functioning |  | week of treatment | 
| Study the incidence of mucositis and esophagitis |  | week of treatment |
Midodrine is Effective in Management of Intradialytic Hypotension Among Critically-ill Patients With Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
The aim of this randomized trial was to assess the efficacy of oral midodrine tablets for the management of intradialytic hypotension among critically ill patients with acute kidney injury.

Detailed Description
-----------------
In This open -label study, patients in ICU with acute kidney injury are randomized to either midodrine tablets or placebo. the number of intradialytic episodes and both systolic and diastolic blood pressure between both groups are compared. Mortality and adverse effects are monitored and compared as well.

Official Title
-----------------
Midodrine is Effective in Management of Intradialytic Hypotension Among Critically-ill Patients With Acute Kidney Injury

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Drug: midodrine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU patients acute kidney injury age above 18 years documented hypotension during dialysis Exclusion Criteria: packed red blood cells transfusion intravenous inotropes alteration of blood pressure medications

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: midodrine group<br>Patients will receive midodrine tablets | Drug: midodrine<br>* oral midodrine tablets 5 mg<br>|
| Placebo Comparator: placebo group<br>Patients receive sugary oral tablets therapy | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hypotensive episodes | Number of hypotensive episodes | 30 days from start of hemodialysis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean systolic blood pressure | compare mean systolic blood pressure between the two arms | 30 days from start of hemodialysis | 
| mean diastolic blood pressure | compare mean diastolic blood pressure between the two arms | 30 days from start of hemodialysis | 
| Mortality in each arm | Number of dead patients in each arm | 30 days from start of hemodialysis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Kidney Injury, midodrine, intensive care unit
Genetic Polymorphisms Affecting Effect of High Intensity Training

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to investigate the effect of high intensity training on maximal oxygen uptake according to the genetic polymorphisms in healthy Korean volunteers.

Official Title
-----------------
Assessment of Genetic Polymorphisms Affecting Effect of High Intensity Training in Korean Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: High intensity training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 30 to 60, healthy male subjects (at screening) Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress. Exclusion Criteria: Volunteer who has past or present history of any diseases following below; liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder Subject who already participated in other trials in 30 days Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion Subject who smokes an average of 20 cigarettes/day or drink > 5 cups of coffee

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: High intensity training<br>9 weeks of supervised training | Other: High intensity training<br>* 9 weeks of supervised high intensity training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of maximal oxygen uptake |  | Baseline and after 6, 9 weeks of training | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High Intensity Training, Genetic Polymorphisms, Genome Wide association study, Single Nucleotide Polymorphism genotype, Subjects
A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and effectiveness of three anti-HIV drug combinations. The three combinations are: (1) efavirenz (DMP 266) plus indinavir; (2) DMP 266 plus zidovudine (ZDV) plus lamivudine (3TC); and (3) indinavir plus ZDV plus 3TC. This study also examines the resistance HIV may have to these drugs and if these drugs are effective over a long period of time.

Official Title
-----------------
A Phase III, Multicenter, Randomized, Open-Label Study to Compare Antiretroviral Activity and Tolerability of Three Different Combination Regimens (DMP 266 + Indinavir, DMP 266 + Zidovudine + Lamivudine, Indinavir + Zidovudine + Lamivudine) in HIV-Infected Patients

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Indinavir sulfate
* Drug: Lamivudine
* Drug: Zidovudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria Concurrent Medication: Excluded: Terfenadine, astemizole, cisapride, triazolam, or midazolam (competition for the enzyme cytochrome P-450 3A4 [CYP3A4] by indinavir could result in inhibition of metabolic breakdown of these drugs and create the potential for serious and/or life threatening events [i.e., cardiac arrhythmia, prolonged sedation]). Rifampin or rifabutin (prohibited because of potential drug interaction with indinavir). Ketoconazole, itraconazole, and clarithromycin. Concomitant systemic therapy for acute opportunistic infection or malignancy. Excluded: Life expectancy less than 12 months. Prior Medication: Excluded: Prior treatment with efavirenz, 3TC, an NNRTI, or an HIV protease inhibitor. Prior antiretroviral agent within 14 days of initiating study treatment. Prior treatment (within 30 days of initiating study treatment) with any other experimental drug for any indication. Patients must: Have a diagnosis of HIV infection. Have CD4 counts greater than or equal to 50 cell/mm3. Have a life expectancy greater than or equal to 12 months. Be post-pubescent.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Indinavir sulfate|nan|
|Drug: Lamivudine|nan|
|Drug: Zidovudine|nan|

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
-----------------
HIV-1, Drug Therapy, Combination, Zidovudine, Drug Resistance, Microbial, HIV Protease Inhibitors, Lamivudine, Indinavir, Genotype, Reverse Transcriptase Inhibitors, efavirenz
Tear Film SARS-nCoV-2 Detection in Symptomatic and Pauci-symptomatic Patients.

Study Overview
=================
Brief Summary
-----------------
To investigate the presence of SARS-nCoV-2 in the tear film of symptomatic and pauci-symptomatic SARS-nCoV-2 positive patients.

Detailed Description
-----------------
The end goal of the study is to show whether or not the virus can be found in the tear film in both symptomatic and less symptomatic patients by means of serial sampling. A sample of the tears / conjunctiva will be taken with a soft brush (similar to a cotton swab) every three days until the end of the hospitalization. In addition, you must complete a questionnaire that assesses the symptoms present.

Official Title
-----------------
Tear Film SARS-nCoV-2 Detection in Symptomatic and Pauci-symptomatic

Conditions
-----------------
Covid19, Eye Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: swabbing of conjunctiva


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject needs to be above 18 years old. The subject is willing to undergo sampling of the conjunctiva. The subject is willing to fill in a questionnaire. The subject is fluent in written and verbal Dutch. The subject is capable of giving informed consent. Applicable for part 1 only: the subject test positive for SARS-nCoV-2 on a nasopharyngeal swab. The time window between a positive nasopharyngeal swab and the first conjunctival swab may be no more than 3 days. Exclusion Criteria: Allergy to Oxybuprocainehydrochloride Pregnancy or lactation

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 |
| --- | --- |
| symptomatic patient<br>The first part of our study is to confirm the detectability of the SARS-nCoV-2 in the tear film of symptomatic patients. | Diagnostic Test: swabbing of conjunctiva<br>* Each eye will be sampled with a single, sterile, nylon, flocked swab<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence of SARS-nCoV-2 in the tear film of symptomatic and pauci-symptomatic SARS-nCoV-2 positive patients. | Conjunctival sampling will be performed on both eyes after the application of a drop of topical anesthesia | during hospitalization every 3 days | 
| Correlations between SARS-nCoV-2 in the tear film | Correlations between SARS-nCoV-2 in the tear film and mild (like anosmia, ageusia, upper and lower respiratory tract infection) or severe symptoms (as pneumonia, need for hospitalization) of COVID-19. | during hospitalization every 3 days |
Single Superior ILM/ERM Flap for the FTMH.

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators will make the only upper flap either from the internal limiting membrane or from the epiretinal membrane to cover the full thickness macular hole.

Detailed Description
-----------------
After the investigators completed the clinical trial NCT05269563, which was a double flap technique; that consists of two flaps from the internal limiting membrane and the epiretinal membrane. The inferior flap was implanted inside the hole, but the upper flap was utilized to cover the hole. The results were encouraging. Therefore, in this study, the investigators will make the only upper flap to cover the full thickness macular hole, to compare both visual and anatomical outcomes with the double flapped technique (NCT05269563) results. Therefore the double flap will be our control.

Official Title
-----------------
Single Superior Internal Limiting Membrane/Epiretinal Membrane Flap for the Full Thickness Macular Hole

Conditions
-----------------
Ophthalmopathy

Intervention / Treatment
-----------------
* Other: Surgical intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Full thickness macular hole Exclusion Criteria: Lamellar and pseudo holes
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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single superior flap technique to secure macular hole closure.<br>The patients are divided into two groups: For the first group, the flap will be carried out under the effect of perfluorocarbon. For the second group, the flap stabilized with methylcellulose. | Other: Surgical intervention<br>* Pars-plana vitrectomy.<br>|
| Active Comparator: Double flap technique to secure macular hole closure.<br>This arm is NCT05269563, we utilize the results as a comparator to the superior single flap technique. | Other: Surgical intervention<br>* Pars-plana vitrectomy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomical outcome | OCT | The fourth weeks post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome | Best corrected visual acuity | The fourth week post-operatively. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Full thickness macular hole, Epiretinal membrane, Internal limiting membrane, Flap
Organ Preservation: Weekly Carboplatin & Taxol w/Concurrent RT for Locally Advanced Laryngeal & Hypopharyngeal CA

Study Overview
=================
Brief Summary
-----------------
Organ Preservation: Weekly Carboplatin & Taxol w/concurrent RT for locally advanced laryngeal & Hypopharyngeal CA

Conditions
-----------------
Laryngeal Neoplasms, Hypopharyngeal Neoplasms

Intervention / Treatment
-----------------
* Drug: Weekly Carboplatin & Taxol w/concurrent RT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with locally advanced laryngeal & Hypopharyngeal CA
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

| Intervention/Treatment |
| --- |
|Drug: Weekly Carboplatin & Taxol w/concurrent RT|Chemotherapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Organ Preservation, Carboplatin, Taxol, RT, laryngeal & Hypopharyngeal CA, Locally advanced laryngeal & Hypopharyngeal CA