linjc16/ctgov huggingface dataset:
Investigation of A Children's Beverage Containing Different Probiotics

Study Overview
=================
Brief Summary
-----------------
Investigating different bioactive ingredients in children's beverages and the effect on blood serum markers.

Official Title
-----------------
INVESTIGATION OF CHANGES IN LEUKOCYTE POPULATIONS AMONG CHILDREN RECEIVING A FOLLOW-ON COW'S MILK-BASED FORMULA CONTAINING DIFFERENT BIOACTIVE INGREDIENTS.

Conditions
-----------------
Immunity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children 2-4 years of age, weight and length for age within the 10th to 90th percentiles as plotted on the NCHS growth chart Consuming cow's milk for at least one month Exclusion Criteria: Serious concurrent illness or acute infection Using systemic antibiotics or steroids Recent probiotic use Feeding difficulties or intolerance to cow's milk Conditions effecting normal growth and development Immunodeficiencies

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 4 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 |
| --- | --- |
| Control<br>A children's milk-based beverage | |
| experimental probiotic 1<br>children's milk-based beverage containing a bioactive ingredient | |
| experimental probiotic 2<br>children's milk-based beverage containing a different bioactive ingredient | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Nissen and Gastroplasty in Gastroesophageal Reflux Disease (GERD)

Study Overview
=================
Brief Summary
-----------------
Laparoscopic Nissen Fundoplication has established itself as the procedure of choice in the surgical management of the majority of patients suffering from gastroesophageal reflux disease (GERD). Postoperative paraesophageal herniation has incidence ranges up to 7% in the immediate postoperative period. This randomized controlled study was scheduled to investigate the role of the posterior gastropexy, in combination with laparoscopic Nissen fundoplication, in prevention of paraesophageal herniation and improvement of postoperative results, in surgical treatment of GERD.

Official Title
-----------------
Laparoscopic Nissen Fundoplication Combined With Posterior Gastropexy in Surgical Treatment of Gastroesophageal Reflux Disease

Conditions
-----------------
Gastroesophageal Reflux Disease, Hiatal Hernia, Barrett's Esophagus, Esophagitis, Dysphagia

Intervention / Treatment
-----------------
* Procedure: Nissen
* Procedure: Gastropexy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Indications for surgical treatment of GERD ASA I, II Exclusion Criteria: ASA III, IV Previous gastric procedures Conversion to open procedure

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nissen<br>Laparoscopic Nissen Fundoplication | Procedure: Nissen<br>* Laparoscopic Nissen Fundoplication<br>|
| Active Comparator: Gastropexy<br>Procedure/Surgery Laparoscopic Nissen Fundoplication combined with posterior gastropexy | Procedure: Nissen<br>* Laparoscopic Nissen Fundoplication<br>Procedure: Gastropexy<br>* posterior gastropexy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laparoscopic Nissen fundoplication combined with posterior gastropexy may prevent postoperative paraesophageal or sliding herniation in surgical treatment of GERD |  | 9-94 months postoperatively |
Preoperative Score of Inguinal Hernias. Is it Useful to Predict Outcomes

Study Overview
=================
Brief Summary
-----------------
To analyze and validate a preoperative score of difficulty of inguinal hernias and its correlation with postoperative outcomes

Official Title
-----------------
Preoperative Score of Inguinal Hernias. Is it Useful to Predict Outcomes

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

Intervention / Treatment
-----------------
* Other: Preoperative classification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male sex Age > 18 years Primary inguinal hernia Unilateral hernia Elective surgery Exclusion Criteria: Recurrent inguinal hernia

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HF<br>Preoperative classification of inguinal hernia | Other: Preoperative classification<br>* Score of inguinal hernia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Rate of postoperative complications | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lenght of operation | Minutes of operation | Intraoperative | 
| Recurrences | Recurrences during follow-up | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inguinal Hernia, Preoperative Score, Kingsnorth Score
Physiological Effects of High-Flow Tracheal Oxygen Via An Modified Interface

Study Overview
=================
Brief Summary
-----------------
Tracheostomy is often performed in patients after or anticipated prolonged mechanical ventilation, who are usually required oxygen therapy after discontinuation of mechanical ventilation.

Detailed Description
-----------------
Tracheostomy is often performed in patients after or anticipated prolonged mechanical ventilation, who are usually required oxygen therapy after discontinuation of mechanical ventilation.The high-flow tracheal (HFT) oxygen therapy in tracheostomized patients has been shown that can improve oxygenation,but can not induce positive end-expiratory pressure and elevation of end-expiratory lung volume. A modified HFT system by increasing expiratory resistance might induce PEEP and consequently elevate EELV.

Official Title
-----------------
Physiological Effects of High-Flow Tracheal Oxygen Via An Modified Interface in Tracheostomized Patients

Conditions
-----------------
Tracheostomy

Intervention / Treatment
-----------------
* Procedure: The modified HFT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The tracheostomized patient requiring the convenient oxygen therapy. Exclusion Criteria: Under 18 years; history of esophageal, gastric or lung surgery; The contraindication of using EIT (pacemaker, defibrillator, and implantable pumps).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The standard HFT<br>The high-flow oxygen was delivered via tracheostomy using a standard HFT. | |
| The modified HFT<br>The high-flow oxygen was delivered via tracheostomy using a modified HFT. | Procedure: The modified HFT<br>* The HFT was modified by increasing the expiratory resistance.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean end expiratory pressure. | The patients was delivering the high flow oxygen via the standard and modified HFT interface for 20 minutes. | the last 1 minutes of steady breathing during the standard or modified HFT. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in global and regional EELV | The Electrical impedance tomography (EIT) was applied in monitoring the change of EELV at the bedside. | the last 1 minutes of steady breathing during the standard or modified HFT. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high flow tracheal oxygen, modified interface
Phase II Study of Intravenous Novantrone(R) in the Treatment of AIDS Related Kaposi's Sarcoma

Study Overview
=================
Brief Summary
-----------------
To study the toxicity and efficacy of IV mitoxantrone hydrochloride (Novantrone) in AIDS-related Kaposi's sarcoma.

Official Title
-----------------
Phase II Study of Intravenous Novantrone(R) in the Treatment of AIDS Related Kaposi's Sarcoma

Conditions
-----------------
Sarcoma, Kaposi, HIV Infections

Intervention / Treatment
-----------------
* Drug: Mitoxantrone hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have the following: Biopsy proven Kaposi's sarcoma in advanced stages. Positive HIV antibody, HIV culture or antigen capture or T4 cells < 500 in a patient with AIDS risk factor. Informed consent and availability for follow-up. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Uncontrolled opportunistic infection. Any medical, surgical or psychiatric condition which would constitute a contraindication to the use of mitoxantrone. Concurrent Medication: Excluded: Zidovudine (AZT). Patients with the following are excluded: Uncontrolled opportunistic infection. Unable to give informed consent. Any medical, surgical or psychiatric condition which would constitute a contraindication to the use of mitoxantrone. Prior Medication: Excluded: More than one form of chemotherapy regimen. Doxorubicin therapy > 300 mg/m2. Prior Treatment: Excluded: Previous therapy consisting of more than one modality of therapy (e.g., chemotherapy plus radiotherapy or more than one form of chemotherapy regimen.)

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mitoxantrone hydrochloride|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
-----------------
Mitoxantrone, Acquired Immunodeficiency Syndrome
Implantation of Porous Titanium Prosthesis in Laryngeal Surgery

Study Overview
=================
Brief Summary
-----------------
This study evaluates a medialization implant to treat vocal cord paralysis, to permit it to adjust the quality of the voice under local or general anesthesia. The aim is to restore phonation using a porous titanium prosthesis in laryngeal surgery.

Official Title
-----------------
Implantation of Porous Titanium Prosthesis in Laryngeal Surgery

Conditions
-----------------
Vocal Cord Paralysis

Intervention / Treatment
-----------------
* Device: Vocal fold medialization (thyroplasty) prosthesis by insertion of a new implant allowing very easy and quick setting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females greater than 18 years old Exclusion Criteria: Age less than 18 years Pregnant women Local carcinoma excluding radiotherapeutic or surgical control Bad general condition Contraindication to general anesthesia Non-controlled diabetes

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 |
| --- |
|Device: Vocal fold medialization (thyroplasty) prosthesis by insertion of a new implant allowing very easy and quick setting|The porous titanium prosthesis is implanted under local anaesthesia. Neck incision is performed in order to expose the thyroidal cartilage. A window is then opened in this cartilage, and the implant is placed in contact with the vocal muscles. The patient is then asked to speak in order to achieve the implant best setting.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasofibroscopy |  | 8 days and 3 months after surgery | 
| Voice control and recording |  | 8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial | 
| All types of complication |  | 8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
porous titanium implants, thyroplasty, vocal cord paralysis, male or female more than 18 years old
Conversation With Family Doctor to Increase COVID-19 Vaccine Uptake

Study Overview
=================
Brief Summary
-----------------
The investigators will randomise individuals from family doctors' lists of patients that are at risk of severe Coronavirus Disease 2019 (COVID-19), and that are not registered as having taken the vaccine against the disease. The patients will be randomised to receiving a phone call from their family physician where the participants are given the opportunity to raise questions they might have around vaccination. The investigators will assess whether this has an impact on vaccine uptake.

Official Title
-----------------
[In Norwegian]: Samtale Med Fastlegen Som Tiltak for å øke Covid-19-vaksinedekningen

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

Intervention / Treatment
-----------------
* Behavioral: Telephone call about vaccination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Belonging to group at risk of severe COVID-19 Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telephone call from family physician<br>Individuals allocated to the experimental arm will receive a phone call from the their family physician, where they are offered the opportunity to raise questions they might have about the COVID-19 vaccine. | Behavioral: Telephone call about vaccination<br>* Participants receive phone call from their family physician, where they are invited to ask questions about the COVID-19 vaccine.<br>|
| No Intervention: Usual care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccination status (COVID-19) | Change in proportion of participants who are registered in the national vaccination registry, as having received at least one dose of a COVID-19 vaccine. | 3-6 weeks after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health services research, Quality improvement
Ultrasound and Left Ventricular Systolic Function

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate, in an intensive care unit, the reproducibility between two non-cardiologists operators and a cardiologist expert in echocardiogram, of the Simpson method and of the calculation of GLS for the evaluation of the systolic function of the left ventricle in critically ill patients intubated and ventilated.

Official Title
-----------------
Ultrasound Evaluation of the Left Ventricular Systolic Function in Intensive Care Unit.

Conditions
-----------------
Dysfunction, Left Ventricular

Intervention / Treatment
-----------------
* Device: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU patients intubated and ventilated Exclusion Criteria: Arrhythmia or variability of heart rate Technical impossibility to perform the ultrasound exam Known pregnancy or lactation Non-affiliation to a social security scheme (beneficiary or assignee) Patient under legal protection Patient refusal to participate

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

| Intervention/Treatment |
| --- |
|Device: Ultrasound|Cardiac echocardiography to determin the left ventricular ejection fraction by the biplane modified Simpson rule and by the calculation of the Strain Longitudinal Global by 2-D speckle tracking strain echocardiography|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reproducibility of measurements of the ejection fraction of the left ventricle by two measurement methods and reproducibility of myocardial strain measurements between operators |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the ROC curve of the value of myocardial strain (GLS) |  | Baseline |
Whether Using Sequential pH Would Improve Human Blastocyst Formation

Study Overview
=================
Brief Summary
-----------------
Any drift in extracellular pH (pHe) from the intercellular pH (pHi) could alter the mechanism regulating transporters and exchangers through the plasma membrane. This could lead to difficulty in restoring the physiological level of pHi. The critical stages that lack robust mechanism of regulating the pHi are the denuded oocyte, early stage of fertilization or a thawed embryo. This, in turn, could lead to a significant effect of the perturbations on embryo development. Convincing evidence regarding the optimal pHe for culturing human embryo is, so far, scanty and mostly anecdotal. The embryo has been reported to have a compensatory mechanism to grow at pHe between 7.0-7.4. Others have recommended that embryo need a sequential pH to viably grow suggesting that the post-genomic activation stage needs a slightly alkaline range of pH. However, whether this holds true remains to be examined.

Official Title
-----------------
Sequential pH Effect on Blastocyst Formation Rate

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

Intervention / Treatment
-----------------
* Other: pH Effect on blastocyst formation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICSI cycles Exclusion Criteria: No exclusion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequential pH culture (7.23 then 7.35)<br>A split embryo at day 3 to continue culture at a pHe of 7.23±0.02 or to be cultured at a pH of 7.35±0.02 and monitor the effect on blastocyst development. | Other: pH Effect on blastocyst formation<br>* to investigate which pH is suitable for each stage of embryo development<br>|
| No Intervention: Continuously pH culture at 7.23<br>Embryo culture from day 0 to 5 or 6 at 7.23 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing Pregnancy rate | women with continued pregnancy at week 12 of gestation | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of usable blastocysts | number of blastocysts suitable for transfer on day 5 or 6 | 6 days of culture | 
| Blastocyst formation rate | number of formed blastocyst per Fertilized oocyte | 6 days of culture | 
| Clinical pregnancy rate | number of women with ultrasound detection of sacs with heartbeat per stimulated cycle | 3 months | 
| Implantation rate | number of sacs with a heartbeat | 7 weeks |
Study Comparing Formulations of Bazedoxifene/Conjugated Estrogens

Study Overview
=================
Brief Summary
-----------------
The primary purpose is to determine bioavailability of Bazedoxifene/conjugated estrogen formulations for future testing purposes.

Official Title
-----------------
An Open-Label, Single-Dose, Non-Randomized, 4-Period Crossover Bioavailability Study of Bazedoxifene Contained in Bazedoxifene/Conjugated Estrogen Tablets Administered to Healthy Postmenopausal Women

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

Intervention / Treatment
-----------------
* Drug: bazedoxifene/conjugated estrogens combination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, post menopausal women ages 45 to 70 Exclusion Criteria: Male subjects

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bazedoxifene/conjugated estrogens combination|nan|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety & tolerability |  |  |