linjc16/ctgov huggingface dataset:
Blood Components Changes by Using of Ringer's Lactated as Detergent In Autologous Blood Cell Transfusion

Study Overview
=================
Brief Summary
-----------------
Placenta accreta spectrum (PAS) disorders are associated with increased maternal morbidity and mortality related to life-threatening hemorrhage, and greater potential need for blood transfusion. Clinical evidences have confirmed that the use of autologous blood cell transfusion is safe and effective for patients with obstetric haemorrhage. Normal saline is the solution recommended for red cell washing, administration and salvage. However, there is growing concern that normal saline is more toxic than balanced, buffered crystalloids such as Lactated Ringer's and Plasma-Lyte. The purpose of this study is to evaluate the blood components using of Ringer's Lactated by a prospective, single-center, open, and single-arm clinical trial.

Official Title
-----------------
Blood Components Changes by Using of Ringer's Lactated as Detergent In Autologous Blood Cell Transfusion: A Prospective, Single-center, Open, and Single-arm Clinical Trial

Conditions
-----------------
Placenta Accreta Spectrum

Intervention / Treatment
-----------------
* Other: Ringer's Lactated


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 18 and 45 years old Without health problem nor disease requiring regular medical treatment Exclusion Criteria: subject with contraindication for drawing blood Subject with physical or mental disability or restriction of liberty that would prevent autotransfusion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1.<br>Using of Ringer's Lactated | Other: Ringer's Lactated<br>* Using of Ringer's Lactated In Autologous Blood Cell Transfusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hematological parameters | erythrocytes (/µL) | Baseline (Day 1), until 2 days after autotransfusion | 
| Change in hematological parameters | hemoglobin (g/dL) | Baseline (Day 1), until 2 days after autotransfusion | 
| Change in hematological parameters | Mean corpuscular volume (fL) | Baseline (Day 1), until 2 days after autotransfusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Placenta Accreta Spectrum, Autologous Blood Cell Transfusion, Blood Components
Study of Amiloride on Vascular Phenotypes in Young Adults With Prehypertension

Study Overview
=================
Brief Summary
-----------------
Primary Specific Aim: To test the hypothesis that amiloride will improve vascular health of young adults with prehypertension.

Conditions
-----------------
Prehypertension

Intervention / Treatment
-----------------
* Drug: Amiloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prehypertensive: Having systolic BP between 120 to 139 mmHg and/or diastolic BP between 80 to 89 mmHg during screening visit. BP will be measured manually tree times at 10 minutes interval after subjects sit quietly for at least 5 minutes in a chair. The average of last two BP measurements will be taken into consideration. Male or female of Caucasian or African-American origin. No history of any major past and current medical illness (such as diabetes, renal disease, liver disease etc.) Not taking any medication that affects blood pressure. Exclusion Criteria: HbA1C > 7.0 % during screening visit. Serum potassium > 5.5 mEq/L during screening and/or any testing visit due to risk of developing hyperkalemia. Serum creatinine > 1.5 mg/100 ml and/or creatinine clearance < 50 ml/min* (Glomerular Filtration Rate Estimate by Abbreviated MDRD Study Equation)35 during screening and/or any testing visit due to risk of developing renal dysfunction. Female having positive pregnancy test during screening and/or any testing visit.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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 |
| --- | --- |
| Other: Amiloride<br> | Drug: Amiloride<br>* Amiloride 10 mg orally once a day for 16 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular phenotypes | (Flow mediated dilation, Pulse wave velocity, and carotid artery compliance) | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prehypertension, Flow mediated dilation, Pulse wave velocity, carotid compliance, Prehypertension and amiloride
Luteal-Phase GnRH Agonist Administration in Frozen-Thawed IVF Embryo Transfer Cycles

Study Overview
=================
Brief Summary
-----------------
Supraphysiological hormonal stimulation enables collecting many oocytes in an In-Vitro Fertilization treatment, but may have a negative effect on uterine function and contribute the fact that the majority of preembryos placed in the uterus fail to implant. Several medical agents were shown to be beneficial when given in the luteal phase of an IVF cycle, but the optimal regimen has not been yet determined. In 2006, a European group reported that addition of GnRH analog (Decapeptyl) as luteal support in IVF cycle significantly improved pregnancy and delivery rates. It is not known whether this positive effect influences the corpus luteum, embryo or the uterus. The researchers sought to evaluate the effect of GnRH administration as luteal support in frozen-thaws IVF cycle.

Conditions
-----------------
Pregnancy Rate

Intervention / Treatment
-----------------
* Drug: Decapeptyl 0.1 mg after embryo transfer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IVF patients transfer of a minimum of two medium-quality thawed embryos in IVF Exclusion Criteria: Two or more fresh IVF embryo transfer or three or more thawed embryos transfer with no pregnancy. maximal endometrial thickness < 6 mm or intracavitary fluid at the time of embryo transfer on previous cycles Untreated hydrosalpinges intracavitary mass submucous myoma known allergy to one of medical agents used in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

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

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: 1<br>GnRH analog administration following embryo transfer | Drug: Decapeptyl 0.1 mg after embryo transfer<br>* Decapeptyl 0.1 mg (Ferring, Kiel, Germany) 3 days following embryo transfer<br>|
| No Intervention: 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy and delivery rates |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GnRH analog, IVF, infertility, frozen-thawed embryos
Safety and Immunogenicity of CYT004-MelQbG10 Vaccine With and Without Adjuvant in Advanced Stage Melanoma Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate a specific cellular immune response in melanoma patients that have been vaccinated with a Melan-A VLP vaccine alone or in combination with different adjuvants.

Official Title
-----------------
Safety, Tolerability, and Immunogenicity of CYT004-MelQbG10 Vaccine With or Without Immunostimulating Adjuvant in HLA-A2 Positive Patients With Stage III/IV Malignant Melanoma

Conditions
-----------------
Malignant Melanoma

Intervention / Treatment
-----------------
* Biological: CYT004-MelQbG10 + Montanide
* Biological: CYT004-MelQbG10 + Montanide + Imiquimod
* Biological: CYT004-MelQbG10 + Imiquimod
* Biological: CYT004-MelQbG10 intra nodal injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological confirmed Stage III or IV malignant melanoma HLA-A*0201 haplotype Expected survival of at least 9 months Willing and able to comply with all trial requirements (e.g. diaries, CTs) Given written informed consent Females only if non-reproductive or if they agree to consistently practice an effective and accepted method of contraception Exclusion Criteria: Any contraindication to any study related test or assessment Current or planned use of contraindicated concomitant medication Presence or history of relevant cardiovascular, renal, pulmonary, endocrine, autoimmune, neurological and psychiatric disease Infection with HIV, HBV or HCV Pregnancy or lactation or females planning to become pregnant during the study Abuse of alcohol or other drugs Use of investigational drug within 30 days before enrolment Previous participation in a clinical trial with a Qb-based Cytos vaccine.

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 |
| --- | --- |
| Experimental: 1<br> | Biological: CYT004-MelQbG10 + Montanide<br> <br> |
| Experimental: 2<br> | Biological: CYT004-MelQbG10 + Montanide + Imiquimod<br> <br> |
| Experimental: 3<br> | Biological: CYT004-MelQbG10 + Imiquimod<br> <br> |
| Experimental: 4<br> | Biological: CYT004-MelQbG10 intra nodal injection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Institutional Outcome Data From Per-oral Plication of the Esophagus

Study Overview
=================
Brief Summary
-----------------
Researchers are reviewing and analyzing surgical and clinical outcomes of subjects who underwent POPE for end-stage achalasia, a sigmoid esophagus, or a redundant conduit that has been used to replace the esophagus. This data will help researchers determine the safety and efficacy of a novel minimally invasive treatment compared to invasive surgery.

Detailed Description
-----------------
Researchers will be collecting electronic medical data for subjects who have already undergone Per-oral Plication of the Esophagus (POPE) procedure. Subject characteristics, radiographic documentation, videos, procedural details, and subject reported outcomes would be collected. This data will be used for review and analysis to answer questions aimed in this study. Data collected from this study will be entered into a database that will be maintained for future research.

Official Title
-----------------
Institutional Outcome Data From Per-oral Plication of the Esophagus (POPE)

Conditions
-----------------
Achalasia

Intervention / Treatment
-----------------
* Procedure: POPE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults > 18 years of age Patients who have already undergone Per-oral Plication of the Esophagus (POPE) procedure Exclusion Criteria: Patients <18 years of age

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 |
| --- | --- |
| POPE Patients<br>Patients who underwent POPE for end-stage achalasia, a sigmoid esophagus, or a redundant conduit that has been used to replace the esophagus. | Procedure: POPE<br>* Patients who have undergone Per-oral Plication of the Esophagus (POPE) procedure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Evaluate safety by assessment of adverse events of the novel minimally invasive treatment compared to invasive surgery. | 01/01/2017-9/17/2018 | 
| Patient Reported Outcomes using the CONDUIT patient questionnaire. | Evaluate efficacy by reviewing patient reported outcomes of the novel minimally invasive treatment compared to invasive surgery. | 01/01/2017-9/17/2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
POPE
The Validity of Modern Mobile Applications in Management of COVID-19 Home Isolation Patients: a Survey for Health Care Professionals

Study Overview
=================
Brief Summary
-----------------
In late 2019, a novel coronavirus, SARS-CoV-2, was identified as the causative agent of a cluster of pneumonia cases (COVID-19) in Wuhan, China. Clinical symptoms of COVID-19 may be mild or severe. The location where a person will self-isolate will be determined by their healthcare provider and their health authority. When determining the location, several factors to determine the suitability of the home setting are described as the case should stay in a room of their own so that they can be isolated from other household members. The rapid increase and evolution of modern mobile applications for communication and messaging for personal purposes have proved great benefit in healthcare management

Official Title
-----------------
The Validity of Modern Mobile Applications in Management of COVID-19 Home Isolation Patients: a Randomized Survey for Health Care Professionals

Conditions
-----------------
the Use of Modern Technology Applications in Home Isolation

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthcare professionals in Ain Shams University, Cairo, Egypt. Exclusion Criteria: junior Staff

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Survey|to assess and validate how healthcare professionals can trigger or inhibit the use of modern technology applications in home isolation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of reassurance delivered from doctors to patients through Whatsapp |  | 3 months |
Use of Probiotic Bacteria in Prevention of Allergic Disease in Children 1999-2008

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to find out if allergic diseases can be prevented buy giving probiotic bacteria to pregnant mothers and their newborn infants

Conditions
-----------------
Atopic Dermatitis, Food Hypersensitivity, Allergic Rhinitis, Seasonal, Allergic Conjunctivitis, Asthma

Intervention / Treatment
-----------------
* Drug: Mixture of probiotic bacteria and prebiotic oligosaccharide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mother or father fo child with doctor diagnoses allergic disease Exclusion Criteria: prematurity, major malformations

Ages Eligible for Study
-----------------
Minimum Age: 37 Weeks
Maximum Age: 42 Weeks

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mixture of probiotic bacteria and prebiotic oligosaccharide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
AGN-229666 Ophthalmic Solution for the Treatment of Seasonal or Perennial Allergic Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of AGN-229666 for the treatment of seasonal or perennial allergic conjunctivitis.

Conditions
-----------------
Conjunctivitis, Allergic

Intervention / Treatment
-----------------
* Drug: AGN-229666


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese patients living in Japan with allergic conjunctivitis with itching and redness Able and willing to discontinue wearing any contact lenses during the study period. Exclusion Criteria: Eye surgical intervention and/or a history of refractive surgery within 6 months History of retinal detachment, diabetic retinopathy, or progressive retinal disease Presence of active eye infection (bacterial, viral, or fungal) History of an eye herpetic infection Use of corticosteroids within 6 months or anticipated use during the study.

Ages Eligible for Study
-----------------
Minimum Age: 10 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: AGN-229666<br>One to two drops of AGN-229666 twice daily in each eye for 10 weeks. | Drug: AGN-229666<br>* One to two drops of AGN-229666 twice daily in each eye for 10 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale | Ocular itching frequency is assessed on a 6-poing scale, where 0 = did not occur, 1 = once in 3 days, 2 = twice in 3 days, 3 = once every day, 4 = 2 or more times every day, and 5 = virtually all the time over the past 3 days. Ocular itching frequency is evaluated over the 3 days prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. | Baseline, Day 70 |
A Multi-Centered Study of the Long-Term Effect of Salmeterol and Albuterol in Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
Long term use of bronchodilators in CF is beneficial to the improvement of pulmonary function and symptoms. This study is investigating the long-term benefit of administration of the drug Salmeterol, a bronchodilator. Salmeterol will be compared to albuterol or placebo. The medication will be inhaled twice a day for 6 months.

Detailed Description
-----------------
Patients that have been diagnosed with cystic fibrosis and are above 5 years and below 45 years of age are eligible. Subjects will be randomized into 1 of 3 groups. One group will get Salmeterol by multi-dose inhaler (MDI) 2 puffs 2 times a day, one group will get albuterol by MDI 2 puffs 2 times a day and the other will get placebo by MDI 2 puffs 2 times a day. Height and weight along with pulmonary function testing and vital signs will be monitored at the beginning of the study and at Visits 2, 3, and 4. Peak flow monitoring will be done each morning before study medication at home. A daily diary will be kept of this measurement. Subjects will be seen in the research center at visits 1,2,3, and 4. Telephone contact will be done at Day 15, 60, 120, and 150. Individual outcomes include a potential increase in pulmonary function testing and a decrease in frequency of pulmonary exacerbations, hospitalizations, and usage of antibiotics.

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: Salmeterol
* Drug: Albuterol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to perform reproducible spirometry FEVI > 50% and < 90% (Knudsen) A CF pulmonary exacerbation within the last year or an FEVI<80% At least one delta f508 allele on CF mutation analysis Ability to demonstrate use of inhaled medicine and FEVI and PEFR monitor Written informed consent Negative serum pregnancy test on enrollment

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 45 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

| Intervention/Treatment |
| --- |
|Drug: Salmeterol|nan|
|Drug: Albuterol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Bariatric Surgery and Pharmacokinetics of Methylphenidate

Study Overview
=================
Brief Summary
-----------------
Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study we investigate the pharmacokinetic effects of bariatric surgery on methylphenidate.

Official Title
-----------------
Bariatric Surgery and Pharmacokinetics Methylphenidate: BAR-MEDS Methylphenidate

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Drug: Methylphenidate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway Being a Norwegian citizen Exclusion Criteria: Having previously undergone resections in the GI-tract

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Methylphenidate|Patients are tested for their normal prescription methylphenidate medication|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methylphenidate concentration in blood serum (area under curve (AUC)) |  | From baseline to 1 year postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, Gastrointestinal tract, Biological availability, Pharmacokinetics, Methylphenidate