linjc16/ctgov huggingface dataset:
Ramosetron OD Tablet and Postdischarge Nausea and Vomiting

Study Overview
=================
Brief Summary
-----------------
Postoperative nausea and vomiting after general anesthesia is one of the common anesthetic complications. If the patient is discharged from the hospital after surgery, proper treatment may be delayed or impossible if nausea and vomiting occurred. Thus, it is necessary to prevent these symptoms beforehand. Patients who underwent day-surgery will be treated with prophylactic ramosetron orally disintegrating tablets to determine whether the frequency of nausea and vomiting is decreased when the patient returned home after discharge.

Official Title
-----------------
Effects of Ramosetron Orally Disintegrating Tablet on the Prophylaxis of Postdischarge Nausea and Vomiting in High-risk Patients Undergoing Day Surgery Under General Anesthesia

Conditions
-----------------
Day Surgery

Intervention / Treatment
-----------------
* Drug: Ramosetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who undergo day-surgery under general anesthesia and are discharged on the day of surgery Exclusion Criteria: Pregnancy or breastfeeding Patients who are taking other serotonin receptor antagonists Patients who have galactose intolerance or Lapp lactase deficiency patients who have glucose-galactose malabsorption

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ramosetron-ODT<br> | Drug: Ramosetron<br>* Ramosetron orally disintegrating tablet 0.1 mg is administered after discharge (postoperative day 1 and day 2)<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the occurrence of postoperative nausea |  | Postoperative 30 minute, 3 hour, 24 hour, and 48 hour | 
| The change in the occurrence of postoperative vomiting |  | Postoperative 30 minute, 3 hour, 24 hour, and 48 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the severity of postoperative nausea | Numerical rating scale range from 0 to 100 (0 = no pain, 100 = the most severe pain imaginable) | Postoperative 30 minute, 3 hour, 24 hour, and 48 hour | 
| The change of patient's satisfaction score | Numerical rating scale range from 0 to 100 (0 = no pain, 100 = the most severe pain imaginable) | Postoperative 30 minute, 3 hour, 24 hour, and 48 hour | 
| The change in the number of postoperative administration of rescue antiemetic drug |  | Postoperative 30 minute, 3 hour, 24 hour, and 48 hour |
Randomized Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Colon Carcinoma Dukes C

Study Overview
=================
Brief Summary
-----------------
This clinical investigation examined the effectivity 5-fluorouracil, of adding levamisol or interferon to 5-fluorouracil, and of a 5-fluorouracil/levamisol/interferon triple combination, in terms of recurrence-free and overall survival in curatively operable colon carcinoma Stage III.

Official Title
-----------------
A Prospectively Randomized Phase III Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Patients With Operated Colon Carcinoma Dukes C (Stage III; T1-4, N1-30, M0).

Conditions
-----------------
Colon Cancer Stage III

Intervention / Treatment
-----------------
* Drug: 5-fluorouracil, levamisol, interferon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically verified, curatively operated colon carcinoma Stage III (R0, T1-4, N1-3, M0) Age: less than 80 years WHO Performace Status > 2 Adequate bone marrow reserve Informed consent Exclusion Criteria: Rectal cancer R1, R2, carcinosis peritonei Start of chemo- or chemo-immunotherapy > 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy Serious concomitant disease, in particular chronically inflammatory large intestine, cardiopathic disease, malignant second carcinoma

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
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 5-fluorouracil, levamisol, interferon|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free survival |  |  | 
| Overall survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fluorouracil, Levamisol, Interferon, Colon cancer
Phamacokinetics and Safety Profiles of DA-5213 10mg in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Phamacokinetics and safety profiles of DA-5213 10mg in Healthy subjects

Official Title
-----------------
An Open Label, Randomized, Single Dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of DA-5213 10mg in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: DA-5213 10mg
* Drug: DA-5213-R 10mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteers BMI between 18.0 and 30.0 kg/m2 Body weight : Male≥50kg, Female≥45kg Exclusion Criteria: Allergy or Drug hypersensitivity Clinically significant Medical History

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br> | Drug: DA-5213 10mg<br>* single dose administration (one tablet once a day)<br>Drug: DA-5213-R 10mg<br>* single dose administration (one tablet once a day)<br>|
| Experimental: Sequence B<br> | Drug: DA-5213 10mg<br>* single dose administration (one tablet once a day)<br>Drug: DA-5213-R 10mg<br>* single dose administration (one tablet once a day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt | area under the curve | [Time Frame: pre-dose 48 hours post-dose] | 
| Cmax | maximum plasma concentration | [Time Frame: pre-dose 48 hours post-dose] |
Paravertebral Blocks: Pilot Study to Compare Nerve Stimulation vs. Anatomic Landmarks in Inguinal Hernia Repair

Study Overview
=================
Brief Summary
-----------------
Primary aim: 1. To compare the nerve stimulation vs. anatomic techniques of paravertebral block of T11-L1 in providing surgical anesthesia for patients undergoing inguinal hernia repair. Secondary aims: Compare VAS pain scores in the two groups of patients over the first 24 hours. Compare opioid intake over the first 24 hours in the two groups of patients.

Official Title
-----------------
Paravertebral Blocks Techniques: A Pilot Study to Compare Nerve Stimulation vs. Anatomic Landmarks for Patients Undergoing Inguinal Hernia Repair

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: PVB using nerve stimulation
* Procedure: PVB using anatomic landmarks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral open inguinal herniorrhaphy Patient must be >18 years of age ASA physical status of I, II, or III Patient competent to provide informed consent Exclusion Criteria: Patient < 18 years of age Pregnant or lactating women Patient unwilling or unable to provide informed consent Contraindications to regional anesthesia Allergy to amide local anesthetics

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Nerve Stimulation<br>Use of nerve stimulator for placement of PVB nerve block | Procedure: PVB using nerve stimulation<br>* 5ml of 1% ropivacaine injected incrementally<br>|
| Other: Anatomic landmarks<br>Use of anatomic landmarks for placement of PVB block | Procedure: PVB using anatomic landmarks<br>* 5ml of 1% ropivacaine injected incrementally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful full block at T11-L1 |  | Every 10 minutes until full block achieved |
Effect of an Oral Supplement on the Total Energy and Protein Intake of Head and Neck Cancer Patients in the Last 2 Weeks of Radiation Therapy

Study Overview
=================
Brief Summary
-----------------
In this study, an oral nutrition supplement has been developed that take into consideration: the nutritional requirements, treatment side-effects and taste preferences of head and neck cancer patients; the acceptance of a supplement when experiencing radiation therapy side-effects; and the taste preferences of head and neck cancer patients which may affect the supplement intake. We hope to increase dietary intake during the last 2 weeks of radiation therapy.

Official Title
-----------------
Efficacy of an Oral Nutrition Supplement on the Total Caloric and Protein Intake of Head and Neck Cancer Patients During the Last 2 Weeks of Radiation Therapy

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: Nutritional Supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older diagnosed with head and neck cancer including the lip, oral cavity, salivary glands, paranasal sinuses, oropharynx, nasopharynx, hypopharynx, larynx and thyroid. all histologic types of cancer all tumour stages according to American Joint Committee for Cancer (AJCC) Staging all forms of RT including standard or investigational for head and neck cancers alert and mentally competent English speaking Exclusion Criteria: an allergy or intolerance to any of the substances used in the nutrition supplement Type I or II diabetes mellitus renal insufficiency unable to swallow additional criteria of all forms of chemotherapy standard or investigational or combination of radiation/chemotherapy standard or investigational for head and neck cancers

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Nutritional Supplement|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total energy and protein intake |  | Study completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
food, diet, oral supplement, head and neck cancer, radiation
Streptococcus Pneumonia: Effects of PCV13 on Pneumococcal Carriage

Study Overview
=================
Brief Summary
-----------------
The specific aim is to evaluate the impact of PCV13 as administered in the pediatric primary care clinic at Boston medical center on the serotype specific carriage of Streptococcus pneumoniae in children < 5. Specifically the investigators will measure the decline in vaccine serotypes, the proportion of children receiving vaccine required to achieve 50% reduction in serotype specific carriage and the correlation between immunogenicity of the specific serotypes and decline in carriage. The study has been extended to complete 5 years of surveillance to determine the new SP serotype distribution at the time presumably a new equilibrium has been achieved.

Official Title
-----------------
Streptococcus Pneumonia: Herd Effects and Emergence of Potentially Virulent Serotypes PCV13_Impact of NP Colonization, Herd Effects and Emergence of Potentially Virulent Serotypes of Pneumococci

Conditions
-----------------
Nasopharyngeal Carriage of S. Pneumoniae

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children < 5 years of age receiving care at Primary Care center at BMC and as many parent(s) as willing to participate Exclusion Criteria: children with facial malformations making NP sampling unacceptable children in foster care
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 |
| --- | --- |
| Children <2 years of age<br>Children <2 years of age with and without respiratory tract infection | |
| Children 2<5 years of age<br>Children 2<5 years of age with and without respiratory tract infection | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasopharngeal Colonization With PCV13 S. Pneumoniae | Proportion of PCV13 serotypes among n=1851 children colonized with any S. pneumoniae | Study years 1-5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pneumococcal vaccine, nasopharyngeal carriage
Development Cellular Models of the Ear and Nose to Study the Mechanisms of Hearing

Study Overview
=================
Brief Summary
-----------------
Development of cells culturesissued from Nose and Ear to study auditory mecanisms. Study of the cis-Modulation of the gene GJB2 for the patients with early presbycusis to identify the genetic cause of hearing loss.

Official Title
-----------------
Development of Cellular Models of the Ear and Nose From Patient Samples to Study the Mechanisms of Hearing

Conditions
-----------------
Hearing Loss, GJB2, Cis Regulation, DFNB1

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hearing loss Presbycusis Exostosis Exclusion Criteria: Genetic hearing loss

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| GJB2 cis regulation | Culture cell model | 2 years |
Terlipressin Administration in Septic Shock Refractory to Catecholamines

Study Overview
=================
Brief Summary
-----------------
terlipressin is given to refractory septic shock patients who do not respond to noradrenalin in Israel and Europe. It is given by bolus injection. we attempt to investigate weather it is better to give it by continuous drip and avoid abrupt changes in BP and heart function

Official Title
-----------------
Terlipressin Administration in Septic Shock Refractory to Catecholamines Bolus vs. Continuous Drip-Phase II

Conditions
-----------------
Septic Shock

Intervention / Treatment
-----------------
* Drug: terlipressin
* Drug: terlipressin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: septic shock patients receiving above 0.5 mcg/kg NA Exclusion Criteria: allergy to terlipressin, CHF, IHD, pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: terlipressin bolus<br>1 mg of terlipressin received one time only | Drug: terlipressin<br>* 1 mg of terlipressin one time only<br>* Other names: glypressin;|
| Experimental: terlipressin drip<br> | Drug: terlipressin<br>* 1 mg of terlipressin in 50 cc of NS given at a drip of a total of 6 h<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CI, SVR,HR,BP, noradrenalin administration,renal function |  | 6 mo | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
septic shock refractory to catecholamines
LEO 29102 Single and Multiple Dose Study by Dermal Application

Study Overview
=================
Brief Summary
-----------------
The principal aim of this study is to obtain safety, tolerability and pharmacokinetic data when LEO 29102 is administered cutaneously as single and multiple doses to healthy male subjects. The study is divided into one single dose part followed by a multiple dose part.

Official Title
-----------------
A Phase 1, First in Man, Safety, Tolerability and Pharmacokinetic Study of Single Ascending and Multiple Cutaneous Doses of LEO 29102 2.5 mg/g Cream or LEO 29102 Cream Vehicle in Healthy Male Subjects

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: LEO 29102


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male adults between the age of 18 and 55 years (both inclusive) and with a BMI between 19 and 30 kg/m2 (both inclusive). Subjects must be healthy as determined by medical history, physical examination, electrocardiogram (ECG), blood pressuer and heart rate, and clinical laboratory evaluation. Exclusion Criteria: Subjects who show signs of eczema or other skin lesions. Subjects who have any clinical signs of allergic diseases (excluding non active hay fever).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>LEO 29102 2.5 mg/g cream | Drug: LEO 29102<br>* First-in-man. Healthy volunteers<br>|
| Placebo Comparator: 2<br>LEO 29102 cream vehicle | Drug: LEO 29102<br>* First-in-man. Healthy volunteers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety and tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the pharmacokinetics |  |  |
Needle-Free Monitoring for IVF Patient Cycles

Study Overview
=================
Brief Summary
-----------------
Salivary diagnostic testing is emerging as a less invasive, inexpensive alternative to serum analyte measurements with proven diagnostic accuracy in clinical settings. This study aims to continue analyzing aspects of the performance of salivary hormone competitive immunoassays for monitoring patient's reproductive hormone profiles in the reproductive cycle. Hormone levels will be monitored during treatment cycles for infertility.

Detailed Description
-----------------
This study will be a prospective study to measure salivary and serum estrogen and progesterone levels in subject's voluntarily undergoing monitored infertility treatment cycles including controlled ovarian stimulation (COS) with oral agents or gonadotropins and controlled ovarian hyperstimulation (COH) for in vitro fertilization (IVF). Ultimately, the potential applicability and reliability of salivary steroid monitoring in IVF cycles will be assessed.

Official Title
-----------------
Venopuncture-Free Monitoring During IVF: Are More Frequent Sequential Salivary Hormone Measurements More Informative Than Daily Serum Monitoring of IVF Patients?

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of infertility. Cycle start age of 25 -43 years. Undergoing controlled ovarian stimulation for IVF. All monitoring scheduled at the participating IVF facility. Exclusion Criteria: -Prior cancelled cycle due to hyperstimulation.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 43 Years

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

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 |
| --- | --- | --- |
| Measurement of multiple Progesterone levels as an aid during an IVF cycle | To determine if collecting multiple salivary Progesterone levels versus a single serum hormone sample could assist in predicting the administration of Human Chorionic Gonadotropin (HCG) during an IVF cycle. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of salivary Estradiol level as an aid during fertility treatment | Comparison of salivary reproductive hormone values versus serum collection to see if there is a correlation between the two methods of collection. | 1 month | 
| Measurement of salivary Progesterone level as an aid during fertility treatment | Comparison of salivary reproductive hormone values versus serum collection to see if there is a correlation between the two methods of collection. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infertility, in vitro fertilization, Estradiol, Progesterone