linjc16/ctgov huggingface dataset:
Retrospective Study of Intestinal Microbiota in Association With Diabetes

Study Overview
=================
Brief Summary
-----------------
The microbiota interacts with several human organs and influences the physiological process in the host. The predominant Phyla of species in the gut microbiota are Bacteroidetes (B) and Firmicutes (F), accounting for 60-80%, and Proteobacteria (P) and Actinobacteria (A) in minority. When some of the bacterial Phyla species are unbalanced, the pathological state of dysbiosis occurs. A laboratory index used for clinical analyzes is the F / B ratio <0.8, which characterizes an intestinal dysbiotic state. Many causes can affect the intestinal microbiota, thus altering it in a dysbiotic state, first of all the diet. In fact, dysbiosis can be characterized both by the severity with which it manifests itself and is also distinguished in putrefactive and fermentative dysbiosis. Furthermore, the variation in the normal percentages of the Phyla is also related to some pathological alterations. The aim of this study will be to monitor the population and heterogeneity of the microbiota in the Italian population. Knowing the complex implications of dysbiosis and the extensive data on it, this study will want to detail the state of the gut microbiota in the previously indicated population, focusing attention on peculiar profiles that could reflect a pathogenic spectrum or metabolic disturbances. The study aims to investigate the diffusion and state of the microbiota in the Italian territory and if it occurs in association with certain pathologies and / or diet.

Official Title
-----------------
Retrospective Study for the Characterization of the Intestinal Microbiota in Association With Pathologies and Diet in the Italian Population

Conditions
-----------------
Dysbiosis Symptoms Linked to Pathology

Intervention / Treatment
-----------------
* Other: Fecal microbiota analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 16 and 80 years old, Patients with completed questionnare Dysbiosis symptoms Exclusion Criteria: Under 16 years old, over 80 years old, patients misidentified

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 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: Fecal microbiota analysis|Data analysis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome percentage Phyla | Change in the percentage of Proteobacteria in type 2 diabetic patients | 2020-2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microbiote, Dysbiosis
Avascular Necrosis (AVN) Long-Term Follow-up

Study Overview
=================
Brief Summary
-----------------
Long-term follow-up of IDE patients for publication

Detailed Description
-----------------
This device (Hedrocel AVN Intervention Implant) was approved via 510(k) on April 15, 2005. One site was left open to follow patients to 5 year follow-up for publication of device survivorship.

Official Title
-----------------
Hedrocel Avascular Necrosis (AVN) Intervention Implant

Conditions
-----------------
Avascular Necrosis, Femoral Head Collapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient qualifies for core decompression based on physical exam No history of core decompression Patient is willing and able to provide written informed consent Exclusion Criteria: Patient has been diagnosed as Stage 0, III, IV, V or VI using the Steinberg/UPenn staging system. Patient's BMI is >40 Patient is mentally compromised Patient has neurological condition in ipsilateral or contralateral limb, which affect lower limb function The patient has had a proximal femoral osteotomy or internal fixation in the affected hip. The patient has undergone previous treatment for AVN Previous hip conditions Patient's bone stock is insufficient Patient has diagnosed systemic disease Patient is a pregnant female Patient is unable or unwilling to attend postop follow-up visits Patient has received investigational drug within the previous 6 months or an investigational device within the last 12 months Patient has an active or latent infection Patient has metal sensitivity Patient is a prisoner

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Safety, Efficacy and longevity of device with patient as opposed to conventional total hip replacement |  | 5 Year Follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AVN, Femoral Head Collapse
A Novel Oral Natural Extract for the Treatment of Senile Purpura

Study Overview
=================
Brief Summary
-----------------
A randomized, double-blind, placebo controlled study to assess the safety and effectiveness of a novel oral natural extract to improve the appearance of the skin of patients with senile purpura.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Study To Assess the Safety and Efficacy of a Novel Oral Natural Extract for the Treatment of Senile Purpura

Conditions
-----------------
PURPURA

Intervention / Treatment
-----------------
* Dietary Supplement: Citrus Bioflavanoid Blend
* Dietary Supplement: Calcium Carbonate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with evidence of purpura on physical exam Exclusion Criteria: Preexisting condition that would not allow the patients to take oral calcium supplement

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Calcium carbonate placebo pill<br>Placebo medication to treat the appearance of the skin in patients with senile purpura | Dietary Supplement: Calcium Carbonate<br>* Oral Tablet Taken Twice a Day<br>|
| Active Comparator: Nutraceutical<br>Patients take a novel, natural nutraceutical product to improve the appearance of the skin of patients with senile purpura | Dietary Supplement: Citrus Bioflavanoid Blend<br>* Pill Taken Twice a Day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IMPROVEMENT IN PATIENT'S SKIN APPEARANCE WITH SENILE PURPURA |  | 6 WEEKS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADVERSE EFFECTS IN PATIENTS WITH SENILE PURPURA TAKING THIS MEDICATION |  | 6 WEEKS | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PURPURA, SENILE PURPURA, BATEMAN'S PURPURA
Postmarketing Surveillance Study to Assess Handling and Patient Satisfaction on Berodual® Respimat® Solution for Inhalation in Patients With Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
New perceptions about handling and patient satisfaction of the everyday use of Berodual® Respimat® in patients with chronic obstructive lung disease (COLD). Moreover, further knowledge should be attained about the tolerability of Berodual® Respimat®

Official Title
-----------------
Berodual® Respimat® 20/50 Microgram/Dose Solution for Inhalation: Assessment of Handling and Patient Satisfaction

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Berodual® Respimat® - inhaler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients aged at least 18 years who were suffering from symptoms of a COLD (naive or pre-treated) could be included in the PMS Exclusion Criteria: Patients who meet one or more of the general or specific contraindications mentioned in the Summary of Product Characteristics (SmPC) are excluded from the Postmarketing Surveillance (PMS)

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 |
| --- | --- |
| Chronic Obstructive Pulmonary Disease patients<br> | Drug: Berodual® Respimat® - inhaler<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events |  | up to 8 weeks | 
| Number of patients who premature discontinued therapy with Berodual® Respimat® |  | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of patient satisfaction with regard to handling of Berodual® Respimat® inhaler | by means of patient satisfaction and preference questionnaire (PASAPQ) | up to 8 weeks |
Dextran, a Plasma Expander, Offers New Hope for Patients With Decompensated Liver Cirrhosis and Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
A pilot study of Dextran-40 infusion in patients with decompensated cirrhosis presenting with AKI

Detailed Description
-----------------
A pilot study of Dextran-40 infusion in decompensated cirrhotic patients complicating with AKI. Dextran-40® was administered at 1 g/kg/day for two days. AKI reversal was defined when serum creatinine was < 1.5 mg/dL. Albumin infusion was given if AKI reversal did not occur.

Official Title
-----------------
Dextran, a Plasma Expander, Offers New Hope for Patients With Decompensated Liver Cirrhosis and Acute Kidney Injury

Conditions
-----------------
AKI, Cirrhosis, Liver

Intervention / Treatment
-----------------
* Drug: Dextran 40


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Decompensated cirrhosis with acute kidney injury Ager over 18 years old Exclusion Criteria: Having chronic kidney disease, severe heart or lung disease, severe sepsis Pregnant Receiving nephrotoxic agents Having history of allergic to Dextran
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
Interventional Model Description: Focus on clinical response after receiving treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dextran 40<br>Dextran 40 infusion | Drug: Dextran 40<br>* Dextran-40 infusion with the dose of 1 g/kg/day (10 ml/kg/day) for 2 days.<br>* Other names: Colloidal plasma expander;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AKI reversal | Reducing creatinine to below 1.5 mg/dl | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Death | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AKI, Cirrhosis, Albumin, Dextran
Efficacy of Lumiracoxib in Relieving Moderate to Severe Post-dental Surgery Pain, Compared to Both Placebo and Celecoxib

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety and efficacy of lumiracoxib 400 mg in relieving moderate to severe post-dental surgery pain, compared to both placebo and celecoxib 400 mg.

Official Title
-----------------
A Randomized, Double-blind, Double-dummy, Parallel Group, Single-center Study Evaluating the Analgesic Effect of Single Doses of Lumiracoxib 400 mg, Celecoxib 400 mg and Placebo in the Treatment of Post-dental Surgery Pain

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Lumiracoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Requiring extraction of two or more partially impacted or fully bony impacted third molars. At least one of the extractions must be mandibular Moderate to severe post-dental surgery pain intensity (as rated by the patient on the categorical pain intensity scale within five hours of surgery Exclusion Criteria: Evidence or history of any cardiac and cerebral thrombotic/ ischemic diseases and/ or events Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 17 Years

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

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: Lumiracoxib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superiority of a single dose of lumiracoxib 400 mg compared to placebo and celecoxib 400 mg based on a Summed (time weighted) Pain Intensity Difference calculated over 0-8 hours post-dose (SPID-8) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate efficacy of a single dose of lumiracoxib 400 mg compared to placebo and to celecoxib 400 mg in relieving post dental surgery pain with respect to the following secondary efficacy variables: |  |  | 
| Time-specific Pain intensity Difference (PID) based on the categorical scale, Pain Relief (PR) based on the categorical scale, and Pain Relief Intensity Difference (PRID) (sum of PID and PR based on categorical scales) at time-points up to 24 hours after |  |  | 
| Time-specific PID based on VAS at time-points up to 24 hours after dosing |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental surgery, acute pain, lumiracoxib, celecoxib, Moderate to severe pain following dental surgery
Evaluation of Obstetrical and Neonatal Complications in Hereditary Haemorrhagic Telangiectasia (HHT)

Study Overview
=================
Brief Summary
-----------------
Hereditary Haemorrhagic Telangiectasia (HHT) is a rare inherited genetic disease of autosomal dominant inheritance with a prevalence of about 1/5000. It is manifested by haemorrhage, mucocutaneous telangiectasia and visceral arteriovenous malformations (AVMs) (lung, liver and nervous system). Severe complications during pregnancy in HHT are rare but considered high risk. Intracranial or pulmonary haemorrhage, stroke and heart failure have been reported in some women with HHT during pregnancy. These complications occur most often in the second and third trimesters when maternal physiological changes such as peripheral vasodilatation and increased cardiac output are at their peak. Previous retrospective studies were conducted with numbers ranging from 40 to 97 patients and highlighted the importance of early screening of complications and specific management. The aim of this study is to describe, on a larger number of patients, the obstetric and neonatal complications in patients with HHT and followed in the French Reference Center for HHT.

Official Title
-----------------
A Retrospective Study of Obstetrical and Neonatal Complications in Hereditary Haemorrhagic Telangiectasia (HHT)

Conditions
-----------------
Osler Rendu Disease, Hereditary Hemorrhagic Telangiectasia

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women ≥ 18 years. Patients monitored for clinically confirmed Hereditary Haemorrhagic Telangiectasia (presence of at least three Curaçao criteria) and / or with molecular biology confirmation. Patients with at least 1 full term pregnancy between 1960 and 2018. Received information and no opposition to participate in the study. Exclusion Criteria: No full term pregnancies. Refusal to participate in the study.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with Hereditary Haemorrhagic Telangiectasia<br>Women with Hereditary Haemorrhagic Telangiectasia with at least one full term pregnancy | Other: Questionnaire<br>* Interview of women with Hereditary Haemorrhagic Telangiectasia (HHT) during a consultation in the Reference Center for HHT or through a phone questionnaire about obstetric history, complications during pregnancy, delivery and neonatal outcomes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of complications during pregnancy | The questionnaire consists in collecting obstetric history (number of pregnancies, abortions), complications during pregnancy, delivery type and neonatal outcomes. | Interview time (about 15 minutes) |
Study Evaluating SCA-136 Tolerability With Dose Titration and Food

Study Overview
=================
Brief Summary
-----------------
To evaluate whether the tolerability of SCA-136 is improved by dosing with food or by increasing dose amounts in a step-wise fashion.

Official Title
-----------------
A Multi-Dose, Double-Blind, Parallel-Group Study of the Effects of Dose Titration and Administration With Food on the Tolerability of SCA-136 in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: SCA-136


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men or women, aged 18 to 50 years Exclusion Criteria: Abnormal vital signs, ECG, or lab results

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SCA-136|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the proportion of subjects reporting nausea (based on AEs) over the dosing period. |  |  |
A Noninterventional, Single-Center Feasibility Study to Evaluate Measures of Heart Failure Risk

Study Overview
=================
Brief Summary
-----------------
This is a non-invasive/observational study in healthy and mild HF subjects utilizing clinical and ambulatory measurements to improve detection, monitoring, and management of HF risks.

Official Title
-----------------
A Noninterventional, Single-Center Feasibility Study to Evaluate Longitudinal Measures of Heart Failure Risk Using the Pyxida System

Conditions
-----------------
Heart Failure, Cardiomyopathy, Hypertrophic, Left Ventricular Hypertrophy

Intervention / Treatment
-----------------
* Device: Software


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Cohort 2: Confirmed medical history of LVH based on American College of Cardiology (ACC)/American Heart Association (AHA) guidelines and NYHA Class I at screening Cohort 3: Confirmed medical history of HF consistent with current ACC/AHA guidelines and NYHA Class I at screening Cohort 4: Confirmed medical history of HCM consistent with ACC/AHA guidelines and NYHA Class I or II at screening Key Exclusion Criteria: Active neurological disorder, such as uncontrolled seizure disorder. Current diagnosis of cancer or other known acute chronic infection, such as hepatitis B or hepatitis C, by medical history or an active infection requiring interventional therapy at screening. Shortness of breath, fatigue, heart palpitations, pain, or other limitations of physical activity

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy subjects<br> | Device: Software<br>* Observation only<br>|
| Asymptomatic left ventricular hypertrophy<br> | Device: Software<br>* Observation only<br>|
| Asymptomatic subjects with a history of HF<br> | Device: Software<br>* Observation only<br>|
| Subjects with a history of hypertrophic cardiomyopathy NYHA Class I, II<br> | Device: Software<br>* Observation only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of complete daily datasets transmitted to the Pyxida System database at the end of the monitoring period |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate subject compliance and experience using the Pyxida System |  | 14 days |