linjc16/ctgov huggingface dataset:
Upper GI Symptoms In Patients Receiving Acetylsalicylic Acid/NSAIDs - NSAIDs Wave 2

Study Overview
=================
Brief Summary
-----------------
The current epidemiological study will be undertaken in GP's and specialized private doctors. In total, 85 general practitioners, orthopedics, rheumatologists and cardiologist will take part in the study. Data will be collected for 850 patients who visit their physician for medical conditions that require the use of acetylsalicylic acid and/or NSAIDS. The first 10 consecutive patients who visit their GP/orthopedic/rheumatologist/cardiologists and are currently receiving acetylsalicylic acid and/or NSAIDS will be included in the study.

Official Title
-----------------
Upper GI Symptoms In Patients Receiving Acetylsalicylic Acid/NSAIDs - NSAIDs Wave 2

Conditions
-----------------
Upper-GI Symptoms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acetylsalicylic acid/NSAIDS intake for at least 5 days of a week during the past month before the patient's visit to the clinician Exclusion Criteria: Patients who are not willing to sign of the Informed Consent Form

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 |
| --- | --- |
| 1<br>Primary care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency (%) of patients in the Greek Primary Practice, presenting Upper GI Symptoms while receiving NSAIDS treatment with/without gastroprotective measures. |  | Single visit / once | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The nature of upper GI symptoms (Dyspepsia and GERD) experienced by patients receiving acetylsalicylic acid and / or NSAIDS treatment |  | single visit / once | 
| To determine the main indications for acetylsalicylic acid and or NSAIDS prescription among GPs and specialized private doctors in Greece. |  | single visit / once | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Upper GI Symptoms, GERD, NSAIDs
Comprehensive Geriatric Assessment - Can it Improve Quality of Life

Study Overview
=================
Brief Summary
-----------------
Like most developed countries the population of Sweden is getting older and consequently the number of individuals with chronic diseases will be an increasing challenge for its healthcare system. To improve care of the frail elderly, wards with a coordinated multidisciplinary team and multidisciplinary mobile teams were established several years ago. Treatment and follow up is planned in accordance to the patients' medical, psychological and functional capabilities (Comprehensive Geriatric Assessment = CGA). There are to our knowledge only few studies concerning CGA applicable to Swedish conditions. We plan to conduct a Swedish study that evaluates if care and treatment with a modified CGA-model in an outpatient setting can improve quality of life for frail older people.

Official Title
-----------------
Comprehensive Geriatric Assessment - Can it Improve Quality of Life

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Other: Experimental: Optimization of treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥65 years Live in own home Reason to believe that the health condition is not optimal or could be optimized Meet at least 2/6 of the following criteria: cognitive impairment, general tiredness or dyspnea, have fallen often/afraid to fall, need help with activities of daily living, hospital care ≥3 times within the last 12 months, care problems at home Exclusion Criteria: Psychosis Not understand the Swedish language

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optimization of treatment<br>Optimization of treatment of diseases and symptoms | Other: Experimental: Optimization of treatment<br>* Optimization of treatment of diseases and symptoms<br>|
| Placebo Comparator: Control<br>Treatment as usual | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retained or increased quality of life of at least 20% measured by EQ-5D (EuroQOL) after 1 year from baseline. |  | 1 year from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission to hospital |  | 1 year from baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polypharmacy
Validation of RPVi as a Parameter to Predict Fluid Responsiveness

Study Overview
=================
Brief Summary
-----------------
This is a prospective, nonrandomized, sequential data collection study to evaluate the ability of RPVi to predict fluid responsiveness in comparison with other dynamic parameters including stroke volume variation (SVV) and/or pulse pressure variation (PPV).

Official Title
-----------------
Validation of RPVi as a Parameter to Predict Fluid Responsiveness

Conditions
-----------------
Anesthesia, Surgery

Intervention / Treatment
-----------------
* Device: Pulse CO-Oximeter sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older at the time of consent Scheduled for elective surgery requiring general anesthesia and mechanical ventilation Arterial line and other standard of care line placement indicated as part of the scheduled surgical procedure Exclusion Criteria: Patients diagnosed with or history of heart failure, angina, pulmonary heart disease, rheumatic heart disease, cardiomyopathy, congenital heart disease, or valvular heart disease. Patients scheduled for or has had a liver transplant Patients with surgeries at or around site of sensor placement or skin abnormalities affecting the sensor placement area such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent monitoring of pulse-oximeter physiological parameters during the study. Patients with cardiac arrhythmias Patients with intracardiac shunts

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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulse Co-Oximeter sensor<br>All subjects are enrolled into this arm and will receive an investigational pulse CO-Oximeter sensors. | Device: Pulse CO-Oximeter sensor<br>* Investigational Pulse CO-Oximeter sensor will measure hemoglobin (SpHb), Pulse Rate (PR), Perfusion Index (Pi), Methemoglobin (SpMet), Pleth Variability Index (PVi), RPVi, etc.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of RPVi to SVV and/or PPV | To evaluate the ability of RPVi to predict fluid responsiveness in comparison with other dynamic parameters including Stroke Volume Variation (SVV) and/or Pulse Pressure Variation (PPV) using Bland Altman analysis. | approximately 2-6 hours during surgery |
Oxytocin Effects on the Tolerance of Infidelity

Study Overview
=================
Brief Summary
-----------------
To investigate whether intranasal oxytocin (40 IU) treatment can influence the tolerance of infidelity in males and females.

Detailed Description
-----------------
In a double-blind, between-subject, placebo controlled design, investigators plan to investigate the effect of oxytocin treatment on the tolerance of infidelity. Male and female subjects would firstly see a neutral face of the opposite sex presented with a sentence descried their fidelity or infidelity behavior (sexual or emotional) in a relationship. Next the participant will rate the attractiveness, likability and trustworthiness of each individual, and whether they would like to have a short/long relationship with him/her. After that there will be some implicit attitude tasks to test their implicit attitude towards potential partners exhibiting previous fidelity or and infidelity.

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

Intervention / Treatment
-----------------
* Drug: oxytocin treatment
* Drug: placebo treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects without past or current psychiatric or neurological disorders Exclusion Criteria: history of head injury; pregnant,menstruating,taking oral contraceptives medical or psychiatric illness.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 28 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: male oxytocin group<br>male subjects with oxytocin treatment | Drug: oxytocin treatment<br>* intranasal administration of oxytocin (40 IU)<br>|
| Experimental: female oxytocin group<br>female subjects with oxytocin treatment | Drug: oxytocin treatment<br>* intranasal administration of oxytocin (40 IU)<br>|
| Placebo Comparator: male placebo group<br>male subjects with placebo treatment | Drug: placebo treatment<br>* intranasal administration of placebo (40 IU)<br>|
| Placebo Comparator: female placebo group<br>female subjects with placebo treatment | Drug: placebo treatment<br>* intranasal administration of placebo (40 IU)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| attitude towards fidelity and infidelity of potential mate. | attitude is measured by the rating scores for likability, attractiveness and trustworthiness | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oxytocin, infidelity
Effects of scFOS on Stool Frequency in People With Functionnal Constipation

Study Overview
=================
Brief Summary
-----------------
The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and constistency of stools in subjects with functional constipation

Official Title
-----------------
Randomized, Placebo-controlled Double-blind Study to Evaluate the Effects of Fructo-oligosachharides on Increase of Stool Frequency in Constipated People

Conditions
-----------------
Functional Constipation

Intervention / Treatment
-----------------
* Dietary Supplement: Short-chain fructo-oligosaccharides
* Dietary Supplement: Maltodextrin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects with functional constipation Exclusion Criteria: subjects treated with laxative treatments subjects consuming more than 25g/day of dietary fibres pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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: short-chain fructo-oligosaccharides<br>Short-chain fructo-oligosaccharides are consummed at 5g/day for 6 weeks | Dietary Supplement: Short-chain fructo-oligosaccharides<br>* Short-chain fructo-oligosaccharides are consummed at 5g/day for 6 weeks<br>|
| Placebo Comparator: Maltodextrin<br>maltodextrins are consummed at 5g/day for 6 weeks | Dietary Supplement: Maltodextrin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of stool emission |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool consistency (Bristol scale) |  | 6 weeks |
Hemodynamic Changes in Connective Tissue Disease

Study Overview
=================
Brief Summary
-----------------
The study serves the identification of early forms of pulmonary arterial hypertension (PAH) in connective tissue disease and the hemodynamic follow-up of the investigated patients. The basic hypothesis is that PAH may start with a remodeling of small pulmonary arteries, which leads to a stiffening of the vessels, indicated by the inability to vasodilatation and thus a disproportional increase in pulmonary pressure during exercise. Recent studies have shown that a proportion of such patients may develop manifest PAH within a few years. The early identification of these patients and the understanding of the natural course of the disease may improve prognosis. The aim of the present study is to investigate hemodynamic and clinical changes in patients with connective tissue disease in a time interval of 3-5 years with a focus on the development of pulmonary hypertension.

Official Title
-----------------
Hemodynamic Changes in Connective Tissue Disease

Conditions
-----------------
Systemic Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Patients with systemic sclerosis, mixed connective tissue disease, (systemic lupus erythematodes) SLE or overlap syndrome Existing exercise Doppler echocardiography or/and right heart catheterization 3-5 years before inclusion Exclusion Criteria: - Severe lung or bronchial disease (FEV1 <60%) Systolic LV dysfunction (LVEF <50%) or diastolic dysfunction > grade I Valvular defect > grade I (except for tricuspid- or pulmonary insufficiency) Uncontrolled systemic arterial hypertension (at rest >150 mmHg systolic or 95 mmHg diastolic) Uncontrolled ventricular arrhythmias Uncontrolled bradycardia or tachycardia supraventricular arrhythmias Myocardial infarction within the last 12 months Pulmonary embolism within the last 12 months Relevant changes in hemodynamic therapy or major surgery within the last 12 weeks Musculoskeletal or peripheral vessel disorders which complicates an ergometry

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic pulmonary pressure at 50 W | change of systolic pulmonary arterial pressure after 3-5 years | 3-5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak (oxygen uptake) VO2 | change of peak VO2 after 3-5 years | 3-5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
systemic sclerosis, pulmonary arterial hypertension
Collection of Blood and Bone Marrow From Patients With Aplastic Anemia for Analysis of Adhesion Molecules, Chemokines and Their Receptors

Study Overview
=================
Brief Summary
-----------------
This study is designed to collect bone marrow and/or peripheral blood cells and plasma, for the analysis of adhesion molecules, chemokines and their receptors from newly-diagnosed aplastic anemia patients, and patients treated with antithymocyte globulin plus cyclosporine

Conditions
-----------------
Aplastic Anemia, Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who fulfilled entry criteria of acquired aplastic anemia age range 16-70 years Exclusion Criteria: Patients complicated with diabetes, tumor, pregnancy, active infection, or connective tissue diseases, such as systemic lupus erythematosus.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 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 |
| --- | --- |
| AA-ATG<br>Acquired Aplastic Anemia Patients Treated with Antithymocyte Globulin plus Cyclosporine | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hematologic response | hematologic response at 6 months following antithymocyte globulin plus cyclosporine treatment, defined as no longer meeting the criteria for severe aplastic anemia | 6 months following antithymocyte globulin plus cyclosporine treatment |
A Dose-Escalation Study of OBP-801 in Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This Phase 1a, single center, open-label, repeat dose study will evaluate the safety, efficacy, and Pharmacokinetics of ascending doses of OBP-801 in patients with advanced solid tumors.

Official Title
-----------------
A Phase 1a Dose-Escalation Study of OBP-801 in Patients With Advanced Solid Tumors

Conditions
-----------------
Solid Tumor

Intervention / Treatment
-----------------
* Drug: OBP-801


Participation Criteria
=================
Eligibility Criteria
-----------------
Patient Inclusion Criteria Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study: Histologically or cytologically confirmed metastatic or unresectable solid tumor. Has failed treatment with all standard therapies for their malignancy. Adequate Karnofsky Performance Status. An expected survival of at least 3 months. Adequate organ and bone marrow function. Signed informed consent form for study participation prior to screening. Patient Exclusion Criteria Patients presenting with any of the following will be excluded in the study: Clinically significant disease as defined by the protocol. Surgical therapy or other therapies within period as defined by the protocol. Any condition that will interfere with compliance with the protocol as determined by investigator.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OBP-801<br> | Drug: OBP-801<br>* OBP-801 will be administered IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (PK) profile; AUC, Cmax, and t1/2 |  | 4 weeks | 
| Objective Response (OR) |  | 22 weeks | 
| Durability of Objective Response (DOR) |  | 22 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HDAC, Epigenetic, Histone, Acetylation
Genetic Study of Antithyroid Drugs Associated Agranulocytosis

Study Overview
=================
Brief Summary
-----------------
Thionamides, the antithyroid drugs, have been widely used to treat hyperthyroidism1. Side effects are found in 1% - 5% of the patients1. One of the most serious side effect is agranulocytosis, which occurs in 0.1% - 0.3 % of the patients1. This might lead to severe infection and sometimes mortality. The underlying mechanism is unclear. An immune phenomenon may be involved because the antigranulocyte antibodies or lymphocyte sensitized to antithyroid drugs are found in these patients6,7. The recognition of major histocompatibility complex class II peptide complexes by T lymphocytes is central to the development of immune response. According to a report in 1996, the HLA DRB1*08032 allele is strongly associated with susceptibility to methimazole-induced agranulocytosis20. Recently, there are new techniques for genetics study. We aimed to identify the associated genetic change of the agranulocytosis side effect of antithyroid drugs. First, we will look at the classical human Leukocyte Antigen (HLA) loci, such as HLA-A, -B, -C, -DR, -DQ and -DP. If no significant change is found in the above genes, we will consider whole exon sequencing with next-generation sequencing, Statistic analysis will include appropriate linkage analysis, association study, variation data analysis, pathway analysis. If we can identify the genetic change and perform genetic examinations before prescription, we can avoid the happening of severe side effects.

Official Title
-----------------
Genetic Study of Antithyroid Drugs Associated Agranulocytosis

Conditions
-----------------
Agranulocytosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with absolute neutrophil count lower than 500/mm3 caused by anti-thyroid drugs Exclusion Criteria: Patients who is younger than 20 years old or older than 85 years old

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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 |
| --- | --- |
| Agranulocytosis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with anti-thyroid drug related agranulocytosis | The investigators review the chart to see if the patients had anti-thyroid drug related agranulocytosis | within 2 month after taking the drug |