linjc16/ctgov huggingface dataset:
Efficacy of Octreotide Treatment in Patients With Primary Inoperable Thymoma

Study Overview
=================
Brief Summary
-----------------
This study will investigate the efficacy of treatment with octroetide in patients with primary inoperable thymoma to reduce tumor size.

Official Title
-----------------
Efficacy of Medical Treatment With Octreotide in Patients With Primary Inoperable Thymoma to Reduce Tumor Size

Conditions
-----------------
Thymoma

Intervention / Treatment
-----------------
* Drug: Octreotide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients aged >18 years Inoperability of thymic tumor. Inoperability is defined as at least adherence of the tumor to the neighbour organs, suspicious to infiltrate neighbour organs so that R0 resection cannot be expected. Positive result in SMS-szintigraphy, Thymomas of all WHO based histological subtypes (Rosai, 1999; Travis 2004) at Masaoka stage III based on histological examination of core biopsies or resection specimens. Patients with and without thymoma associated paraneoplastic syndrome Demonstrated tolerance to a test dose of s.c. octreotide injection at Visit 1. Exclusion Criteria: Performance status 0,1, or 2 (ECOG) Symptomatic cholelithiasis, Pretreatment with octreotide (longn acting release) within the 3 months Patient has received any other investigational agents within 28 days of first day of study drug dosing Patient is < 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study) Other protocol-defined inclusion/exclusion criteria apply

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: Sandostatin<br> | Drug: Octreotide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shrinkage of tumor size and diameter of 3 respectively 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resection status after 3 respectively 6 months |  | 3 - 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open label, phase II, disease, clinical trial, Octreotide, thymoma, cancer, tumor
Itch and Clinacal Caracteristics in Systemic Sclerosis

Study Overview
=================
Brief Summary
-----------------
Systemic sclerosis (SSc) has heterogeneous symptoms and significant medical morbidity. Recently, itch was described as a symptom of SSc (prevalence of 42,6%). To the investigators knowledge, no study yet has examined the clinical features of itch neither had used a specific itch-related quality of life (QoL) scales in patients with SSc. The objectives were to evaluate the prevalence of pruritus, its characteristics and its impact on the QoL in those patients. In this descriptive study, patients followed for SSc in the departments of dermatology, rheumatology, internal medicine and pulmonology at the University Hospital of Brest were included. Participants received a questionnaire including questions about the clinical features of pruritus and 2 scores (5-D itch scale, ItchyQol).

Conditions
-----------------
Pruritus, Systemic Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged more than 18 years followed for systemic sclerosis since 2000, in the departments of dermatology, rheumatology, internal médicine or pneumology at the University Hospital of Brest. Exclusion Criteria: lower than 18 years refusal to participate

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 |
| --- | --- | --- |
| Pruritus | Pruritus: yes/no | Day 1 (questionnaire sent to patient) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of the systemic sclerosis | Duration of the disease | Day 1 (questionnaire sent to patient) | 
| Brest questionnaire | questions about the chronology, location, intensity, disruption of daily activities, characteristics of scratching and other associated sensations | Day 1 (questionnaire sent to patient) | 
| 5-D itch scale | Validated questionnaire about severity of pruritus using five items (duration, intensity, evolution, impact on daily activities, localisation) | Day 1 (questionnaire sent to patient) | 
| ItchyQol scale | questionnaire about quality of life linked to pruritus | Day 1 (questionnaire sent to patient) | 
| Characteristics of the systemic sclerosis | treatments, | Day 1 (questionnaire sent to patient) | 
| Characteristics of the systemic sclerosis | topography of skin involvement (limited or diffuse systemic sclerosis) | Day 1 (questionnaire sent to patient) |
Long Term Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety and tolerability of the combination of aliskiren and amlodipine given to patients with essential hypertension. This study is being conducted to support registration of the fixed combination of aliskiren/amlodipine in the treatment for hypertension in Japan.

Official Title
-----------------
A Open-label, 52 Week, Extension to an 8-week, Double Blind, Multicenter, 6-arm, Placebo-controlled, Parallel Group Study to Evaluate the Long Term Safety of SPA100 (Aliskiren/Amlodipine)

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: Ali/Amlo 150/2.5 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that complete CSPA100A1301 study Patients whose blood pressure at Visit 7 of CSPA100A1301 study must be well controlled Exclusion Criteria: Patients who experienced any serious adverse events considered drug related in CSPA100A1301 study Presence of major protocol violation in CSPA100A1301 study Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Ali/Amlo<br>Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg | Drug: Ali/Amlo 150/2.5 mg<br>* Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety of the fixed-dose combination of aliskiren/ amlodipine | Measure the number patients withof AE, SAEs and analyze cahanges in safety labs. | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the change from baseline in blood pressure effects of the combination of aliskiren/ amlodipine. | this endpoint will measure the change from baseline for mean sitting diastolic blood pressure, mean sitting systolic blood pressure, supine diastolic blood pressure, supine systolic blood pressure, standing diastolic blood pressure, and standing systolic blood pressure. | 52 weeks | 
| The proportion of patients achieving the blood pressure control target of <140/90 mmHg at the end of study |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aliskiren, Amlodipine, Essential hypertension, Long term
Aplastic Anemia Epidemiology: Incidence and Case-control

Study Overview
=================
Brief Summary
-----------------
To conduct incidence and case-control studies of aplastic anemia in metropolitan Bangkok, Thailand

Detailed Description
-----------------
BACKGROUND: Aplastic anemia, a form of bone marrow failure, is a disease of largely unknown cause, except for the rare situations involving high doses of radiation. Many agents have been mentioned in case reports to be associated with the development of aplastic anemia and include drugs, chemicals, pesticides, radiation, and viral infection. Of these, chloramphenicol, phenylbutazone, and insecticides are most frequently reported. In the United States and other developed countries the disease prevalence is so low that too few cases occur to make an epidemiological study in a single city logistically feasible. The Bangkok hospitalization rate for aplastic anemia was sufficient to conduct a case-control study. Also, a study conducted in this locale provided information on drugs and chemicals not commonly used in developed countries. DESIGN NARRATIVE: All aplastic anemia cases in metropolitan Bangkok were located and verified in the forty hospitals that agreed to participate in the study. Incidence rates were calculated by age group and sex. In the case-control study, interviews were used to obtain comprehensive histories of drug, chemical, pesticide, radiation, viral infections, and other exposures, along with relevant demographic and medical history information in order to examine the association between and test hypotheses regarding suspected hazards and to estimate the risks of developing aplastic anemia. The basic epidemiologic features of aplastic anemia were described by characterizing these patients in terms of standard demographic variables, age, race, sex, and medical history. The degree of association between viral hepatitis and the development of aplastic anemia was estimated. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Blood Disease, Anemia, Aplastic

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
A National Registry of Patients With Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
A registry of patients with the diagnosis of hepatocellular carcinoma.

Detailed Description
-----------------
The purpose of this research is to study the factors which might cause hepatocellular carcinoma (a form of cancer arising within the liver) and compare these factors in patients from different ethnic groups and from different parts of the United States. The researchers will also conduct a survey of the stage of the cancer (how far advanced it is) and what treatments are used for this difficult-to-treat tumor.

Official Title
-----------------
A National Registry of Patients With Hepatocellular Carcinoma

Conditions
-----------------
Carcinoma, Hepatocellular

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosis of hepatocellular carcinoma Exclusion Criteria: Patients can not be under 18 years of age
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 |
| --- | --- | --- |
Effect of Pioglitazone on Ambulatory Blood Pressure

Study Overview
=================
Brief Summary
-----------------
The anti-diabetic pioglitazone has been found to reduce casual blood pressure. To date, no data are available looking at this effect in detail. Especially, ambulatory blood pressure has not yet been utilized to confirm the hypothesis that pioglitazone has blood pressure lowering effects.

Official Title
-----------------
Effect of Pioglitazone on Ambulatory Blood Pressure

Conditions
-----------------
Hypertension, Diabetes Mellitus Type 2

Intervention / Treatment
-----------------
* Drug: Pioglitazone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 45-75 years Diabetes mellitus Type 2 (HbA1c 7 - 8.5%) Casual blood pressure > = 130/80 mmHg, < 160/100 mmHg Exclusion Criteria: Therapy with insulin Combination therapy of sulfonyl-urea und metformin Therapy with nateglinid, repaglinid or an other substance of this drug family Allergy against pioglitazone or other composites of the tablet History of heart failure (NYHA I bis IV) Hepatic insufficiency Transaminases > 2.5-fold of the upper normal limit End-stage renal failure Syndrome of polycystic ovaries Absence of effective contraception in women of childbearing potential Pregnancy or breast-feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pioglitazone<br>Pioglitazone 45 mg, 8 weeks | Drug: Pioglitazone<br>* 45 mg 8 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median of systolic 24-hour ambulatory blood pressure | Change of 24-hour blood pressure after 8 weeks of treatment | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median of 24-hour diastolic ambulatory blood pressure | Change of 24-hour diastolic blood pressure after 8 weeks of treatment | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension
PACMAN - PAcing for CardioMyopathies, a EuropeAN Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the benefit of biventricular pacing in patients with heart failure who were receiving optimal pharmacological therapy, and who were either with or without an ICD indication

Detailed Description
-----------------
Heart Failure is a syndrome that affects millions of patients in Europe with over half a million new cases reported annually. Drug therapy had been the conventional treatment of choice until the emergence of cardiac resynchronization therapy (CRT) where biventricular pacing can be delivered to the heart through a pacemaker or implantable cardioverter defibrillator. This study was designed to assess the effect of CRT on patients optimized on conventional heart failure medication including diuretics, beta blockers and ACE inhibitors. The effect of CRT was evaluated by comparison of 6 minute walk performance, Quality of Life and NHYA class after 6 months with CRT therapy either programmed ON or OFF. In addition, evaluation of the incidence of adverse events (predefined as ventricular arrhythmias, hospitalizations, drop-outs, complications and patient deaths) was done between groups at 6 months. Patients were all programmed ON after 6 months and data was collected for an additional 6 months.

Official Title
-----------------
Pacing for Cardiomyopathies, a European Study- A Therapy Acceptance Study

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Contak heart failure devices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - NYHA Class III and IV with EF < 35%; Optimal individual drug therapy in 2 weeks prior to enrollment including ACE inhibitors; beta blockers and diuretics unless not tolerated Exclusion Criteria: Reduced life expectancy of < 6 months or candidate for heart transplant within 6 months; chronic/recurrent atrial fibrillation/flutter

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Contak heart failure devices|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in functional capacity as measured by a six-minute walk test at 6 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Quality of Life at 6 months; Improvement in NHYA classification at 6 months; incidence of adverse events at 6 months |  |  |
Pore Excision, Curettage, and Injection of Cymetra for Pilonidal Disease

Study Overview
=================
Brief Summary
-----------------
Chronic pilonidal disease is a common problem with no ideal treatment. This is a prospective study that will evaluate the results of surgical pore excision, curettage, and injection of a regenerative tissue matrix, Cymetra, on patients with chronic pilonidal disease.

Detailed Description
-----------------
In addition, the study will evaluate the credibility and reproducibility of results within other surgeons trained to perform the procedure. Data collection will focus on post-operative wound failure, infection ratwes, analgesic requirements, time lost from work or school, wound care requirements, and 6 month recurrence rates. These outcomes will be compared to outcomes using conventional pilonidal surgical intervention using published data.

Official Title
-----------------
Pore Excision, Curettage, and Injection of a Tissue Scaffold as Treatment for Pilonidal Disease

Conditions
-----------------
Pilonidal Sinus

Intervention / Treatment
-----------------
* Procedure: surgery (Pore Excision, Curettage, and Injection of Cymetra)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient with pilonidal diseas
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

| Intervention/Treatment |
| --- |
|Procedure: surgery (Pore Excision, Curettage, and Injection of Cymetra)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound failure, time lost from work or school, analgesic requirements, recurrence rates |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infection rates, wound care requirements |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cymetra
Combined Intracameral Lidocaine for Manual Small Incision Cataract Surgery Under Topical Anesthesia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether intraocular lidocaine increases patient comfort during the different stages of MSICS while under topical anesthesia.

Official Title
-----------------
Combined Intracameral Lidocaine for Manual Small Incision Cataract Surgery Under Topical Anesthesia

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Procedure: MSICS under topical anesthesia with intracameral lidocaine
* Procedure: MSICS under topical anesthesia with intracameral balanced salt solution.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both men and women Cataract density grade III-V according to the Emery-Little system classification system Patients need to do manual small incision cataract surgery Exclusion Criteria: Legal guardian(s) is/are not present for permission Any patient with a known sensitivity or allergy to Lidocaine or the Caine family of medicines. Patients with altered levels of pain perceptions
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraocular lidocaine,topical anesthesia,MSICS<br>experimental group:manual small incision cataract surgery under topical anesthesia with intracameral lidocaine | Procedure: MSICS under topical anesthesia with intracameral lidocaine<br>* manual small incision cataract surgery(MSICS) under topical anesthesia with intracameral lidocaine<br>|
| Experimental: intracameral balanced salt solution,topical anesthesia,MSICS<br>control group:manual small incision cataract surgery under topical anesthesia with intracameral balanced salt solution. | Procedure: MSICS under topical anesthesia with intracameral balanced salt solution.<br>* manual small incision cataract surgery(MSICS) under topical anesthesia with intracameral balanced salt solution.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| observed levels of pain |  | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Topical analgesia, FlACC Pain Scale, intracameral lignocaine, Anesthetics, Physiological Effects of Drugs, Lidocaine