linjc16/ctgov huggingface dataset:
Clinical Evaluation of Sutures in Periodontal Surgery

Study Overview
=================
Brief Summary
-----------------
The aims of this study were to evaluate and compare tissue erythema, edema and knot loosening among four types of suture one week after periodontal surgery.

Detailed Description
-----------------
Forty patients participated in this prospective, randomized, double-blind clinical trial. Vertical mattress sutures were used following resective periodontal surgery performed by one operator. Four suture materials were selected for evaluation: 5-0 silk; 5-0 polypropylene; 5-0 polyglycolic acid (PGA), and 4-0 polytetrafluoroethylene (PTFE). Seven days after the surgical procedure, the surgeon assessed suture loosening and removed the sutures. A blind researcher clinically evaluated erythema and edema.

Official Title
-----------------
Clinical Evaluation of Four Types of Suture in Periodontal Surgery

Conditions
-----------------
Periodontal Debridement

Intervention / Treatment
-----------------
* Procedure: Periodontal resective surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Qualification for the study was based on the need for resective periodontal surgery (apically positioned flap and osseous recontouring) at four or more consecutive interproximal sites per quadrant Exclusion Criteria: systemic diseases, such as diabetes, chronic obstructive pulmonary disease, or an immunologic disease that would affect wound healing; allergies to prescribed medication; and/or current pregnancy or breast feeding were excluded from the study

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Suture in Periodontal resective surgery<br>Four types of suture including silk, polypropylene, PGA, and PTFE | Procedure: Periodontal resective surgery<br>* surgical periodontal debridement is performed after periodontal phase I<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence or absence of Suture loosening | Seven days after the surgical procedure, the surgeon assessed suture loosening; recording loose or not Loose | seven days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence and level of erythema and edema. | Seven days after the surgical procedure a blind researcher clinically evaluated erythema and edema. Adding a score related to a gingival index | seven days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
periodontal debridement, sutures, tissue reaction
Interpersonal and Social Rhythm Therapy Enter the Brief Title for Protocol IRB 09-003781>

Study Overview
=================
Brief Summary
-----------------
In patients with bipolar disorder referred for psychotherapy, is interpersonal and social rhythm therapy delivered in a group psychotherapy format over 2-3 weeks feasible? This project will help determine if interpersonal social rhythm therapy can be delivered in the programmatic format being considered for the outpatient mood program.

Official Title
-----------------
Feasibility of Interpersonal and Social Rhythm Therapy for Outpatients With Bipolar Disorder

Conditions
-----------------
Bipolar Disorder, Depressed

Intervention / Treatment
-----------------
* Behavioral: Interpersonal and Social Rhythm Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Adult patients with a confirmed diagnosis of Bipolar disorder in a depressed phase. Referral for Interpersonal and Social Rhythm Therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Other: Interpersonal and Social Rhythm Therapy<br>All participants receive eight sessions of Interpersonal and Social Rhythm Therapy. | Behavioral: Interpersonal and Social Rhythm Therapy<br>* Interpersonal and Social Rhythm Therapy delivered in two individual therapy sessions and six group therapy sessions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom improvement and patient satisfaction with group and programmatic format in the delivery of interpersonal and social rhythm therapy. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar, Depressed
Non-Invasive Determination of Cardiac Output by Electrical Velocimetry

Study Overview
=================
Brief Summary
-----------------
The cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac diseases. The current standard methods for the determination of the CO, however, are either invasive (e.g. right heart catheterization) or technically expendable and expensive (magnetic resonance tomography, MRT). Therefore the aim of the study at hand was to evaluate the electrical velocimetry technique as a new method for determining the CO and to compare this new technique with the Inert Gas Rebreathing Method and with the Magnetic Resonance Tomography

Official Title
-----------------
Non-Invasive Determination of Cardiac Output by Electrical Velocimetry Compared With Magnetic Resonance Tomography and Inert Gas Rebreathing Method

Conditions
-----------------
Cardiac Diseases

Intervention / Treatment
-----------------
* Device: electrical velocimetry
* Device: inert gas rebreathing
* Device: spirometry
* Device: cardiac magnetic resonance imaging (CMR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for CMR Ability of following instructions for electrical velocimetry test, rebreathing test and spirometry

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: electrical velocimetry|determination of cardiac output by electrical velocimetry|
|Device: inert gas rebreathing|determination of cardiac output by inert gas rebreathing|
|Device: spirometry|spirometry for testing the ventilatory function|
|Device: cardiac magnetic resonance imaging (CMR)|CMR examination which delivers the hemodynamic reference parameters|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Neuronal and Sensory Perception of Fat

Study Overview
=================
Brief Summary
-----------------
This project will examine neuronal and sensory fat perception. Our hypothesis is that subjects being either hypersensitive or hyposensitive for fat will show different brain activities. Therefore the investigators will conduct functional magnetic resonance imaging (fMRI) and fat detection threshold tests examining neuronal and sensory fat perception.

Official Title
-----------------
Fat and the Brain-Neuronal and Sensory Fat Perception

Conditions
-----------------
Fat Perception in the Brain

Intervention / Treatment
-----------------
* Dietary Supplement: yogurt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy Exclusion Criteria: lactose intolerance fMRI contraindications (metal implants,...)

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: Basic Science
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>Fat detection threshold test, intake of high and low fat yogurt, fMRI-measurements | Dietary Supplement: yogurt<br>* Subjects will receive yogurt with varying fat concentrations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat detection thresholds | A sensory test will be conducted to establish individual fat detection thresholds. It is expected that subjects* brain activity is dependent on sensory fat sensitivity. | each measurement day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain activity | We are interested in brain activations following the consumption of yogurt with either a high or a low fat concentration. To assess this, before as well as after fat intake brain activity will be measured using functional magnetic resonance imaging (fMRI). We expect that brain activity will differ between the high and the low fat yogurt condition. | pre and post meal intake |
A Study of Albuferon With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 2 or 3

Study Overview
=================
Brief Summary
-----------------
A Study of Albuferon with Ribavirin in Interferon Alfa Naive Subjects with Chronic Hepatitis C Genotype 2 or 3.

Detailed Description
-----------------
A Randomized, Multi-Center, Open-Label Study To Evaluate The Efficacy And Safety Of Albuferon (HGS 1008, Recombinant Human Albumin-Interferon Alfa Fusion Protein) In Combination With Ribavirin In Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 2 OR 3

Official Title
-----------------
A Randomized, Multi-Center, Open-Label Study To Evaluate The Efficacy And Safety Of Albuferon (HGS 1008, Recombinant Human Albumin-Interferon Alfa Fusion Protein) In Combination With Ribavirin In Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 2 OR 3

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: Albuferon
* Drug: Ribavirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a clinical diagnosis of chronic hepatitis C on the basis of detectable serum HCV RNA during the screening period and at least a 6-month history of exposure to risk factors for HCV. Have never received treatment with an interferon alfa product or an interferon alfa combination product. Have HCV genotype 2 or 3. Have compensated liver disease with the following minimum criteria: white blood cell count (WBC) >3,000/mm3, absolute neutrophil count (ANC) > 1,800/mm3, platelets >100,000/mm3, hemoglobin (Hb) > 13 g/dL for males and > 12 g/dL for females. Exclusion Criteria: Evidence of decompensated liver disease. Pregnant or lactating female. History of any other medical disease or condition that would make the subject (in the opinion of the investigator) unsuitable for the study. A current drug or alcohol addiction.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Albuferon|nan|
|Drug: Ribavirin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary safety endpoints are the common side effects of IFNa therapy including flu-like symptoms, depression, and hematologic abnormalities. |  |  | 
| Primary efficacy end point is sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks after the end of therapy. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C, Chronic, Genotype 2 or 3, Treatment naive
Optimal Treatment Frequency of 308-Nm Excimer Laser for Vitiligo on the Face and Neck

Study Overview
=================
Brief Summary
-----------------
To determine the optimal treatment frequency of 308-nm excimer laser for vitiligo and identify the key clinical variable(s) associated with the treatment efficiency under the optimal treatment frequency. Prospective, randomized, comparative study among groups of vitiligo patients treated with 308-nm excimer laser, with the limitation of no follow-up.

Detailed Description
-----------------
Vitiligo patients were treated with 308-nm excimer laser for 20 sessions at different frequencies (0.5×, 1.0×, 2.0× and 3.0× weekly). Treatment protocols adapted the dose to the lesions and not to the minimal erythemal dose. Treatment efficacy was blindly evaluated by 2 independent physicians. Re-pigmentation rate was graded on a 6-point scale. The onset of re-pigmentation of vitiligo lesions was evaluated after 5 treatment sessions. The differences between Group 0.5×, 1.0×, 2.0× and 3.0× linking different clinical variables were assessed.

Official Title
-----------------
Optimal Treatment Frequency of 308-Nm Excimer Laser for Vitiligo on the Face and Neck

Conditions
-----------------
Vitiligo

Intervention / Treatment
-----------------
* Device: 308-nm excimer laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 2 years, stable vitiliginous patches during the past 3 months with surfaces of at least 4cm2, and an understanding of all information given by signing a written consent form. Exclusion Criteria: pregnant or breastfeeding women; personal history of a hypertrophic scar, skin cancer; taking immunosuppressive or photosensitizing drugs and undergoing phototherapy during the past 3 months.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 308-nm excimer laser|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
308-nm excimer laser, vitiligo
TBTC Study 25PK: Intensive Pharmacokinetic Study of Three Doses of Rifapentine and 25-Desacetyl Rifapentine

Study Overview
=================
Brief Summary
-----------------
Primary objective: To compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three different doses: 600 mg, 900 mg, and 1200 mg. Secondary objective: To describe any correlation between pharmacokinetic parameters of three different doses of rifapentine plus a standard dose of isoniazid and the occurrence of toxicity attributed to anti-tuberculosis treatment.

Detailed Description
-----------------
We will enroll 24-36 patients, 8-12 at each dose of 600, 900 and 1200 mg rifapentine Admissions for pharmacokinetic studies will take place during the continuation phase of tuberculosis therapy. Patients participating in a double-blinded trial of the tolerability and safety of higher doses of rifapentine during continuation phase therapy and consenting to participate in the pharmacokinetic study may be admitted to a Clinical Research Center (CRC) to allow for frequent blood sampling over a 24-hour period. Otherwise, patients will be evaluated in the clinic.

Official Title
-----------------
Intensive Pharmacokinetic Study of Three Doses of Rifapentine (600, 900 and 1200mg) During Continuation Phase Therapy of Tuberculosis in HIV-Negative Adults

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Drug: Rifapentine
* Drug: 25-desacetyl Rifapentine
* Drug: Isoniazid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Patients enrolled in TBTC Study 25 Informed consent Exclusion: Severe anemia (Hct <25%) Any severe adverse event related to study drugs in TBTC Study 25

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rifapentine|nan|
|Drug: 25-desacetyl Rifapentine|nan|
|Drug: Isoniazid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three difference doses: 600 mg, 900 mg, and 1200 mg |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe any correlation between pharmacokinetic parameters of three different doses of rifapentine plus a standard dose of isoniazid and the occurrence of toxicity attributed to anti-tuberculosis treatment. |  |  |
EMBRACE1: Prostate Biorepository

Study Overview
=================
Brief Summary
-----------------
The objective of this multi-center prospective observational clinical study is to evaluate the clinical performance of the Carisome Prostate assay as an aid in the diagnosis of prostate cancer in men that have been scheduled for a prostate biopsy. Primarily, results of the Carisome Prostate assay will be compared with pathology results of prostate biopsy procedures. Secondarily, the performance of the Carisome Prostate test will be compared to the current standard of care for the detection of prostate cancer.

Official Title
-----------------
Evaluation of a Novel Circulating Microvesicle-Based Multi-analyte Assay for the Detection of Prostate Cancer in Men With Elevated Risk for Prostate Cancer; the EMBRACE1 Study

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men scheduled for a routine prostate biopsy expected to produce a pathology evaluation and report Blood draw within 7 days prior to scheduled prostate biopsy procedure Blood draw on the day of but prior to biopsy Exclusion Criteria: Any previous diagnosis of cancer with the exception of non-melanoma skin cancer Any prior or ongoing treatment for prostate cancer including prostatectomy or hormone therapy Prostate biopsy within one month of blood draw Previous enrollment in the Caris Life Sciences Biorepository

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Routine prostate biopsy patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carisome Prostate Assay with prostate biopsy outcome | Association of Carisome Prostate Assay result with prostate biopsy outcome | up to 6 months |
Development and Effects of a Structural Education Program in Adult Kidney Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Kidney transplantation is the treatment of choice for patients with end-stage renal disease. The purpose of this randomized and controlled study is to evaluate the efficacy of a structured education program for adult kidney transplant recipients. Patients are randomly assigned to an educational program or to a standard care control group. The education group receives 8 lessons (each 90 minutes, 1 lesson per day), starting 4 days after kidney transplantation. Kidney transplant survival, number of rejections, infectious complications, length of hospital stay, blood pressure, HbA1c, glomerular filtration rate, quality of life (QoL) and knowledge are measured in both groups after 6, 12 and 24 months. The investigators postulate that the education group will have superior outcomes compared to the control group.

Official Title
-----------------
Development an Effects of a Structural Education Programm in Adult Kidney Transplant Recipients

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Other: Structured education program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being over 18 years recently had a kidney transplantation able to speak, write and understand german willing to participate regular visits after kidney transplantation Exclusion Criteria: severe complications after recent kidney transplantation early loss of the kidney allograft severe allograft dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Education<br>Kidney transplant recipients, who undergo the structured education program | Other: Structured education program<br>* structured education program after kidney transplantation<br>|
| No Intervention: Control<br>Kidney transplant recipients without structured education programm | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transplant survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of rejections |  | 2 years | 
| days at hospital |  | 2 years | 
| blood pressure control |  | 2 years | 
| number of infectious complications |  | 2 years | 
| quality of life (QoL) |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
education program, kidney transplantation, renal transplantation, evaluation