linjc16/ctgov huggingface dataset:
Safety and Pharmacokinetics of Azelaic Acid Foam, 15% in Papulopustular Rosacea

Study Overview
=================
Brief Summary
-----------------
Assessment of pharmacokinetics of Azelaic Acid Foam after repeated skin application and in comparison to Azelaic Acid gel. Assessment of safety after repeated skin application.

Official Title
-----------------
Investigator-blinded, Randomized, Cross-over, Multiple Dose Phase I Study on Safety and Pharmacokinetics of Topically Applied Azelaic Acid Foam, 15% Compared to Azelaic Acid Gel, 15% in Subjects With Papulopustular Rosacea

Conditions
-----------------
Papulopustular Rosacea

Intervention / Treatment
-----------------
* Drug: Azelaic Acid Foam
* Drug: Azelaic Acid Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of moderate papulopustular rosacea free of any clinically significant disease Exclusion Criteria: body weight less than 50 or more than 130 kg clinically significant disease which could interfere with the study

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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azelaic Acid Foam 15%<br>Dermal application of Azelaic Acid Foam 15% | Drug: Azelaic Acid Foam<br>* Dermal application of Azelaic Acid Foam<br>|
| Active Comparator: Azelaic Acid Gel 15%<br>Dermal application of Azelaic Acid Gel 15% | Drug: Azelaic Acid Gel<br>* Dermal application of Azelaic Acid Gel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline corrected area under the curve (AUC) |  | 12 hours |
Late Effect of Ablation on Premature Ventricular Complex Ablation

Study Overview
=================
Brief Summary
-----------------
Premature Ventricular Complex (PVC) ablation is performed in certain indications. Generally acutely abolition of PVC at the time of ablation accepted as successful ablation. However in some patients this effect occurs lately. In this study investigators sought late effect of ablation

Detailed Description
-----------------
On tissue level ablation lesion deepens and enlarges by time following the procedure. Based on this, investigators aimed to seek patients who has no acute success but late success. This phenomenon occurs in some patients. Investigators investigate the characteristics of those patients on both procedural and clinical aspects. Investigators enroll patients applied during prespecified dates

Official Title
-----------------
Late Effect of Ablation on Premature Ventricular Complex Ablation

Conditions
-----------------
Premature Ventricular Complex, Electrophysiology, Ablation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had both of the criteria below Presence of premature ventricular complex requiring ablation Successfully abolition of premature ventricular complex hours after the procedure Exclusion Criteria: Patients who had either of below mentioned criteria Abolition of premature ventricular complex during the procedure Unsuccessful procedure

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 |
| --- | --- | --- |
| Success | Continuation of ablation on the long term | 3 months |
Effect of Dietary Fiber Supplement on the Intestinal Microbiota Among Schizophrenia Patients

Study Overview
=================
Brief Summary
-----------------
Background There has been much interest in the relationship between the types of gut microbiota and the development of obesity in recent years. It has been reported that the proportions of Firmicutes and Bacteroidetes differ between obese and normal weight human subjects. Human intestinal microbiota compositions have been found to be associated with long-term dietary habits and lifestyle. However, an increasing number of researches show that intestinal microbiota composition may be affected after short-term diet intervention. Importantly, obesity and metabolic problems play important roles in morbidity and mortality of schizophrenia patients. Human intestinal microbiota compositions related with obesity may impact the heath of this population. Therefore, we searched current advances about the connection of obesity, intestinal microbiota compositions, and diet in schizophrenia to conduct a clinical research focus on the effect of high fiber diet on the intestinal microbiota of schizophrenia patients with central obesity. Method We will investigate in a 4-week intervention whether consumption of dietary fiber supplement(Inulin) affect the microbiota composition in schizophrenia inpatients with central obesity. Fecal samples from participants before and after the intervention will be processed for the microbiota analysis.

Official Title
-----------------
The Effect of Dietary Fiber Supplement on the Intestinal Microbiota Among Schizophrenia Patients With Central Obesity: a Pilot Study

Conditions
-----------------
Schizophrenia, Central Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: dietary fiber


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schizophrenia inpatients Overweight and with central obesity agree to sign informed consent Exclusion Criteria: Diagnosis of IBS Systemic antibiotic use during the past 4 weeks Excessive water intake

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?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dietary fiber intervention group<br> | Dietary Supplement: dietary fiber<br>* We will investigate in a 4 week intervention whether consumption of dietary fiber supplement affect the microbiota composition in schizophrenia patients with central obesity.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in microbiota composition at week 4 | Fecal samples from participants before and after the intervention will be processed for microbiota analysis | 4 weeks |
Endodontic Microsurgery With the Use of L-PRF and an Occlusive Membrane: a Randomized Controlled Clinical Trial

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effect of leucocyte and platelet rich fibrin (L-PRF) during endodontic microsurgery (EMS) on patient's post-operative comfort and periapical bone healing. Also the influence of an occlusive membrane barrier in EMS on the periapical bone healing will be studied. The trial design is an open randomized controlled clinical trial with a 2x2 factorial design. Half of the participants will receive EMS with L-PRF (experimental group), the other half without (control group). The control and experimental group will be divided in 2 subsequent groups: half of the participants will receive an occlusive membrane during EMS, the other half not.

Official Title
-----------------
Endodontic Microsurgery With the Use of L-PRF and an Occlusive Membrane: a Randomized Controlled Clinical Trial

Conditions
-----------------
Periapical Periodontitis

Intervention / Treatment
-----------------
* Procedure: EMS
* Device: + occlusive membrane
* Device: conebeam CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of Informed Consent Patients in need of an EMS EMS is the only option to cure the periapical lesion Exclusion Criteria: Unlikely to be able to comply with the study procedures, as judged by the investigator Orthograde endodontic (re)treatment is indicated Known or suspected current malignancy History of chemotherapy within 5 years prior to study History of radiation in the head and neck region History of other metabolic bone diseases History of bleeding disorders HIV disease

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: + L-PRF<br>With leukocyte and platelet rich fibrin | Procedure: EMS<br> <br> Device: + occlusive membrane<br> <br> Device: conebeam CT<br> <br> |
| Active Comparator: - L-PRF<br>Without leukocyte and platelet rich fibrin | Procedure: EMS<br> <br> Device: conebeam CT<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient related outcomes | Assessed with a Visual Analog Scale | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient related outcomes | Assessed with a questionnaire | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
platelets
Epidemiological Study of Chronic Thromboembolic Pulmonary Hypertension in China

Study Overview
=================
Brief Summary
-----------------
Chronic thromboembolic pulmonary hypertension (CTPH) is associated with considerable morbidity and mortality. Its incidence after pulmonary embolism and associated risk factors are not well documented in Chinese population. We conducted a prospective, long-term, follow-up study to assess the incidence of symptomatic CTPH in consecutive patients with an acute episode of pulmonary embolism but without prior venous thromboembolism. Patients with unexplained persistent dyspnea during follow-up underwent transthoracic echocardiography and, if supportive findings were present, ventilation-perfusion lung scanning and pulmonary angiography. CTPH was considered to be present if systolic and mean pulmonary-artery pressures exceeded 40 mm Hg and 25 mm Hg, respectively; pulmonary-capillary wedge pressure was normal; and there was angiographic evidence of disease.

Conditions
-----------------
To Assess the Long-term Risk for Adverse Events After PE.

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with an episode of acute symptomatic pulmonary embolism without prior pulmonary embolism or venous thrombosis Exclusion Criteria: Have other diseases (e.g., systemic sclerosis or severe emphysema) that could have caused nonthromboembolic pulmonary hypertension, Have preexisting exertional dyspnea, Geographically inaccessible for follow-up, Decline to participate in the study.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Consecutive patients with acute PE<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cumulative incidence of symptomatic CTEPH |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for Recurrent VTE and CTEPH |  | 2 years |
Changes in Refractive Error in Patients With Both Partially Refractive Esotropia and Amblyopia

Study Overview
=================
Brief Summary
-----------------
To investigate changes in refractive errors and evaluate clinical outcomes of strabismus surgery in patients with both amblyopia and partially refractive esotropia (PAET).Amblyopic patients with PAET were enrolled. Non-amblyopic patients with full refractive accommodative esotropia (RAET) were included in the study as a control group. Preoperative and postoperative best corrected visual acuity (BCVA), spherical equivalent (SE), astigmatism, stereoacuity and deviations at near and distance were evaluated and statistically compared in the patient group. The mean BCVA, SE, astigmatism were compared between the patient and the control groups.

Detailed Description
-----------------
Purpose: To investigate changes in refractive errors and evaluate clinical outcomes of strabismus surgery in patients with both amblyopia and partially refractive esotropia (PAET). Material-Method: Amblyopic patients with PAET were enrolled. Non-amblyopic patients with full refractive accommodative esotropia (RAET) were included in the study as a control group. Preoperative and postoperative best corrected visual acuity (BCVA), spherical equivalent (SE), astigmatism, stereoacuity and deviations at near and distance were evaluated and statistically compared in the patient group. The mean BCVA, SE, astigmatism were compared between the patient and the control groups.

Official Title
-----------------
Changes in Refractive Error in Patients With Both Partially Refractive Esotropia and Amblyopia

Conditions
-----------------
Refractive Errors, Esotropia, Amblyopia Strabismic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: amblyopic children with partially refractive accommodative esotropia as study group non- amblyopic children with fully refractive accommodative esotropia as control group - Exclusion Criteria: Systemic diseases Neurological disorders and diseases Additional ocular diseases

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 15 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 |
| --- | --- |
| Group 1, patients with amblyopia and partially refractive ET<br>children with both amblyopia and partially refractive accommodative esotropia | |
| Group 2, patients with refractive ET<br>children with refractive esotropia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spherical equivalent | spherical error plus half of the cylindirical error measured by retinoscopy, diopter | 36 months | 
| cylindirical error | cylindirical error measured by retinoscopy, diopter | 36 months |
Uric Acid Study in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to examine the effect of AZD6140 on the levels of certain chemicals in subjects' blood and urine.

Official Title
-----------------
A Randomised, Double-Blind, Two-Period Crossover Study to Assess the Effect of AZD6140 on Uric Acid Levels in Healthy Male Volunteers

Conditions
-----------------
Gout, Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: AZD6140
* Drug: Placebo to match AZD6140


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal physical examination, vital signs, electrocardiogram (ECG) and laboratory values (unless the investigator considers an abnormality not to be clinically significant) Normal laboratory tests at screening Non-smoker (no cigarette/tobacco use for at least 6 months) Exclusion Criteria: Personal or family history of gout, gouty arthritis, or renal stones

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

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

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: 1<br> | Drug: AZD6140<br>* Oral tablets taken bid for 5 days<br>|
| Placebo Comparator: 2<br> | Drug: Placebo to match AZD6140<br>* Oral tablets taken bid for 5 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of AZD6140 on the levels of certain chemicals in subjects' blood and urine. |  | Levels or certain chemicals in subjects' blood and urine will be measured at scheduled times during the first 7 days of the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The blood levels of AZD6140 in various subjects on the same diet. |  | following dosing during the first 5 days of the study | 
| The effect of taking AZD6140 on the levels of certain hormones in urine |  | during the first 5 days of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uric, Acid, Level
Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the non-inferior efficacy of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel when compared to Clindamycin 1% / Benzoyl Peroxide 5% Gel in Subjects with acne vulgaris after a 12-week treatment period.

Official Title
-----------------
Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Compared to Clindamycin 0.1% / Benzoyl Peroxide 5% Gel in the Treatment of Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: Adapalene BPO


Participation Criteria
=================
Eligibility Criteria
-----------------
Male or female Subjects of any race, between the age of 12 and 35 years inclusive, with acne vulgaris, meeting specific inclusion/exclusion criteria. Main inclusion criteria: Male or female Subjects of any race, aged 12 to 35 years inclusive, with facial acne vulgaris, Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, Subjects with a minimum of 30 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose. Main exclusion criteria: Subjects with acne cystic lesions, Subjects with acne conglobate, acne fulminancy, secondary acne (chloracne, drug-induced acne, etc.).

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 35 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Adapalene BPO|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from Baseline in total lesion count (sum of non inflammatory and inflammatory lesions) at week 12. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from Baseline in total inflammatory and non inflammatory lesion counts at each intermediate visit |  |  | 
| Global severity assessment at each post Baseline visit |  |  |
Effectiveness and Safety of Breeded Leech for Symptomatic Primary Arthrosis of the First Carpometacarpal Joint

Study Overview
=================
Brief Summary
-----------------
In this trial the investigators want to prove the efficacy and safety of a one-time topical leech application at patients with symptomatic primary arthrosis of the first carpometacarpal joint in comparison to the standard therapy with topical diclofenac.

Official Title
-----------------
Effectiveness and Safety of Breeded Leech Medileech by BioRepro GmbH for Symptomatic Primary Arthrosis of the First Carpometacarpal Joint: a Randomized Controlled Clinical Trial

Conditions
-----------------
Rhizarthrosis

Intervention / Treatment
-----------------
* Biological: Leeches
* Drug: Diclofenac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients aged 35 to 85 years Pain intensity in the region of the thumb base in pain phases ≥ 40 mm on the VAS of 0 to 100 mm (relative to the last 24 hours) Complaints for at least 3 months X-ray Stadium Eaton I-IV at least once secured Exclusion Criteria: Anticoagulation (Marcumar, Heparin) Haemophilia, V. Willebrandt Jürgens syndrome, thrombocytopathy and other blood anomalies Combination therapy of ASA and thienopyridines Pain medication with opioid analgesics Systemic medication with corticoids or immunosuppressants Intraarterticular injections or RSO within the last 3 months Past or planned surgery on the affected joint in the next 2 months Pregnancy, lactation Insulin-dependent type I diabetes mellitus Acute psychotic disorders Severe comorbidity

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Leeches<br>One-time topical application of 2-3 leeches (medileech, Hirudo verbana) periarticularly on the painful thumb base | Biological: Leeches<br> <br> * Other names: Hirudo verbana;|
| Active Comparator: Diclofenac<br>3 times daily topical application of Diclofenac gel (1 g with 10 mg diclofenac-Na) over 4 weeks | Drug: Diclofenac<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disabilities of the Arm, Shoulder and Hand (DASH) |  | Change after 28 and 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (VAS) |  | Change after 7, 28 and 56 days | 
| Medication on demand | Documentation in daily diary | Documentation between baseline and day 56 |