linjc16/ctgov huggingface dataset:
DSP-3025 A Phase 1 Study of Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
Investigate safety/tolerability after repeated weekly doses intranasal administration of DSP-3025 comparator placebo to healthy male volunteers

Official Title
-----------------
A Double-blind, Placebo-controlled, Randomised Study to Investigate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Repeated Weekly Doses of DSP-3025 Administered Intranasally to Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: DSP-3025
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) between 18.5 and 25 kg/ m2 and a weight between 50 and 80 kg No clinically relevant abnormal findings Exclusion Criteria: Acute illness which requires medical intervention Definite or suspected personal history of adverse drug reactions or drug hypersensitivity Clinical relevant disease or disorder (past or present) A history of respiratory disorder(s) such as asthma

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 39 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 30 ug<br>30 ug | Drug: DSP-3025<br> <br> |
| 60 ug<br>60 ug | Drug: Placebo<br> <br> |
| Placebo<br>Placebo | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry |  | During the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical chemistry, haematology, urinalysis, autoantibodies |  | During the study | 
| Nasal symptoms and peak nasal inspiratory flow |  | During the study | 
| Pharmacokinetics |  | During the study | 
| Biomarkers nasal lavage and blood |  | During the study |
Specific Molecular Signatures Predict Neoadjuvant Chemotherapy Response in Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
Cervical cancer is one of the major health problems for chinese women. Besides surgery and radiotherapy, neoadjuvant chemotherapy has been proved to be an effective program by many studies. However, not all patients respond well to neoadjuvant chemotherapy. Knowing the therapeutic effect of the neoadjuvant chemotherapy before receiving it can not only reduce the economic burden, but also more importantly save time to take more suitable treatments. This study is undertaken to build specific molecular signatures to predict the effects of neoadjuvant chemotherapy.

Official Title
-----------------
Accurate Prediction and Validation of Response to Neoadjuvant Chemotherapy in Cervical Cancer

Conditions
-----------------
Uterine Cervical Neoplasms, Cervical Cancer, Uterine Cervical Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Untreated cervical cancer with FIGO stage Ib-IIb Measurable lesions Possible to radical hysterectomy Age: 18 and older Karnofsky Performance Status≥ 70. WBC > 3,000/mm³, Hb > 9.0g/dl, Platelet > 100,000 /mm³, SGOT/SGPT < 60 IU/L, T-Bil < 1.5 mg/dL, Cr < 1.2 mg/dL, PaO2 > 80 torr, normal ECG Written informed consent Exclusion Criteria: Previous history of cancer Patients with previous treatment Patients without information of clinical risk factors Patients who have active infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| neoadjuvant chemotherapy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The clinical response to neoadjuvant chemotherapy | clinical response（tumor size） | 1 to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pathological response to neoadjuvant chemotherapy | pathological response（<3 mm or not） | 1 to 3 months |
Treatment of Fibromyalgia Using Deep Shaped-Field Transcranial Magnetic Stimulation a Clinical Feasibility Study

Study Overview
=================
Brief Summary
-----------------
Deep shaped-field transcranial magnetic stimulation is a new type of transcranial magnetic stimulation technology which may provide a drug-free method for treating fibromyalgia. The purpose of this study is to determine the effectiveness and the durability of effect of Deep shaped-field repetitive transcranial magnetic stimulation (rTMS) in men and women diagnosed with fibromyalgia.

Official Title
-----------------
Treatment of Fibromyalgia Using Deep Shaped-Field (DSF) Transcranial Magnetic Stimulation (TMS): A Clinical Feasibility Study

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Device: DSF-rTMS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fibromyalgia as diagnosed by American College of Rheumatology (ACR) criteria. Moderate or severe pain from fibromyalgia despite current treatment regimen. Will not become pregnant during study. Exclusion Criteria: Seizure disorder. Metal implants on or in brain, spinal cord, ear, eye or heart. Current use of proconvulsant medications (e.g., bupropion). Taking oral amitriptyline > 100 mg once daily at bedtime. Nonscheduled analgesic, anticonvulsant or antidepressant medications. Severe depression or suicidality. Other significant psychiatric disorder. Previous use of TMS.

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 |
| --- | --- |
| Experimental: Active DSF-rTMS<br>Active rTMS treatment. | Device: DSF-rTMS<br>* Effective Transcranial Magnetic Stimulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline on the Brief Pain Inventory (BPI) |  | Daily during 20 day treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline on the Beck Depression Inventory Second Edition (BDI-II) |  | 1, 6, 10, 15 day of treatment; 1 day, 4 weeks post treatment | 
| Change from Baseline for the Fibromyalgia Impact Questionnaire (FIQ) |  | 1, 10 day of treatment; 1 day and 4 weeks post treatment | 
| Durability, safety and tolerability |  | Measured weekly up to 1 month after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibromyalgia, Transcranial Magnetic Stimulation, Pain
Intervention to Preserve Beta-Cell Function in GAD Ab-Positive Diabetes

Study Overview
=================
Brief Summary
-----------------
We tested the hypothesis that insulin therapy rather than sulfonylurea (SU) treatment has a preferable outcome to reverse or preserve beta cell function in the patients with diabetes that is called slowly progressive insulin-dependent (type 1) diabetes (SPIDDM) or latent autoimmune diabetes in adult (LADA).

Detailed Description
-----------------
In a multicenter, randomized, nonblinded clinical study, 4,089 non-insulin dependent diabetic patients were screened for glutamic acid decarboxylase autoantibodies (GADAb). Sixty GADAb-positive non-insulin requiring diabetic patients with duration of diabetes =/<5 years were assigned to either the SU group (n = 30) or the Insulin group (n = 30). Serum C-peptide response to annual oral glucose tolerance tests were followed for 57 mean months. The primary endpoint was insulin-dependency (IDDM: integrated C-peptide values [sigma C-peptide] <4 ng/ml).

Conditions
-----------------
GAD Ab Positive Clinically Type 2 Diabetic Patients

Intervention / Treatment
-----------------
* Drug: Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects should use SU agents to obtain as a goal good glycemic control. Duration of diabetes within 5 years from the onset (or diagnosis). Exclusion Criteria: Subjects having history of hyperglycemia requiring insulin treatment and/or history of ketosis/ketoacidosis were excluded. Subjects with malignant diseases, systemic inflammatory diseases, renal or liver disorders or malabsorption were also excluded.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Insulin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint was insulin-dependency (IDDM: integrated C-peptide values [sigma C-peptide] <4 ng/ml). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SPIDDM, LADA, GAD antibody, Beta cell function, Insulin
A Safety and Efficacy Study of MSI-1256F (Squalamine Lactate) To Treat Wet Age-Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
Age-Related Macular Degeneration (AMD) is a degenerative eye disease of the retina that causes a progressive loss of central vision. AMD is the leading cause of legal blindness among adults age 50 or older in the Western world. AMD presents in two different types - dry and the more severe wet form. Wet AMD is caused by the growth of abnormal blood vessels in the macula. Squalamine lactate is an investigational drug that may prevent the growth of these abnormal blood vessels. This study will test the safety and efficacy of Squalamine in the treatment of AMD.

Conditions
-----------------
Macular Degeneration

Intervention / Treatment
-----------------
* Drug: MSI-1256F (Squalamine Lactate)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of wet age-related macular degeneration Exclusion Criteria: Prior treatment of wet age-related macular degeneration in the affected eye in the past 3 months

Ages Eligible for Study
-----------------
Minimum Age: 50 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: MSI-1256F (Squalamine Lactate)|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
-----------------
Subfoveal Choroidal Neovascularization, Squalamine Lactate
Dermatological Evaluation of Topic Compatibility-Dermacyd Tina Gel Sweet Flower

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Tina Gel Sweet Flower.

Official Title
-----------------
Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Tina Gel Sweet Flower.

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: Lactic acid (Dermacid)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Phototype Skin I,II, III e IV Integral skin test in the region Exclusion Criteria: Lactation or gestation Use of Antiinflammatory and/or immunosuppression drugs Personnel history of atopy History of sensitivity or irritation for topic products Active cutaneous disease Use of new drugs or cosmetics during the study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lactic acid (Dermacid)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absence of primary and accumulated dermal irritability and dermal sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. |  | six weeks |
A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol.

Study Overview
=================
Brief Summary
-----------------
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of cholesterol medications to see how the different treatments compare to one another.

Detailed Description
-----------------
For additional information please call: 1-800-718-1021

Official Title
-----------------
A Phase 3, Open-Label, Multisite, Randomized, Parallel Group Study of the Efficacy and Safety of Fixed Combination Torcetrapib/Atorvastatin Administered Once Daily (QD) Compared to Simvastatin for 6 Weeks in Subjects With Hypercholesterolemia (A5091030)

Conditions
-----------------
Hyperlipidemia, Dyslipidemia, Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: torcetrapib/atorvastatin
* Drug: simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: eligible for statin treatment for LDL cholesterol by NCEP guidelines Exclusion Criteria: Women who are pregnant or lactating, or planning to become pregnant. Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors. Subjects with significant liver or kidney disease or significant heart failure.

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: torcetrapib/atorvastatin|nan|
|Drug: simvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in LDL-C and HDL-C from baseline, after six weeks of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in other lipid parameters and other biomarkers. |  |  |
Rehabilitation Coordinators in Specialist Psychiatry

Study Overview
=================
Brief Summary
-----------------
REKO-A is a randomized controlled intervention study that addressed women and men on sick leave in Uppsala County. Participants which are on sick leave due to mental illness.

Official Title
-----------------
Rehabilitation Coordinators in Specialist Psychiatry

Conditions
-----------------
Mental Disorder, Rehabilitation

Intervention / Treatment
-----------------
* Behavioral: Rehabilitation Coordinator in Specialist Psychiatry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be on sick leave Have moderate to severe affective and / or moderate / severe anxiety disorder, such as: Bipolar disorder, depression, posttraumatic stress disorder, generalized anxiety disorder, neuropsychiatric disability Enrolled at the Academic hospital in Uppsala Exclusion Criteria: High suicidal risk Extensive somatic disorders (somatic multichannel) Patients outside Uppsala County Taking part in an ongoing vocational rehabilitation

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention with rehabilitation coordinator<br> | Behavioral: Rehabilitation Coordinator in Specialist Psychiatry<br>* Rehabilitation Coordinator service in Specialist Psychiatry<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to work (RTW)/entry into work or studies | Number of Participants that have RTW/entry into work or studies | 1 year | 
| Magnitude of sick leave | Proportion of sick leave in the study population | 1 year | 
| Length of sick leave | Sick leave duration | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mental Disorder, Rehabilitation
Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to conduct a population pharmacokinetic analysis of caspofungin in a population of patients with moderate and severe acute alcoholic hepatitis or liver disease with Child-Pugh score B and C in order to better characterize pharmacokinetic parameters in case of moderate and severe liver dysfunction.

Detailed Description
-----------------
patients admitted for alcoholic hepatitis or decompensated cirrhosis and Child-Pugh score 7-9 and 10-15 will be included; all patients without invasive aspergillosis.

Official Title
-----------------
Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure

Conditions
-----------------
Bacterial Infections and Mycoses, Liver Disease

Intervention / Treatment
-----------------
* Drug: Caspofungin 70 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver failure Child-Pugh B and C Exclusion Criteria: Cachexia (BMI < 15 kg/m²) Pregnancy HIV Hepatitis C patients

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Caspofungin 70 mg<br>Infusion of one dose of Caspofungin 70 mg | Drug: Caspofungin 70 mg<br>* Intravenous use<br>* Other names: Cancidas;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of serum caspofungine concentrations to determine the pharmacokinetic parameters of Caspofungin in patients with liver failure | one dose of caspofungin will be given to patients with hepatic failure. Serum sampling will be performed during 96 hours. Measurements of caspofungin in the serum will be performed to study the pharmacokinetics of this drugs and will be compared with pharmacokinetics of subjects with normal liver function. For safety, patients will be followed during 14 days. | 14 days |
Utility of Intra-operative Image Guidance System for Missing Metastases

Study Overview
=================
Brief Summary
-----------------
Intraoperatively, the surgeon will interrogate the liver with ultrasound. The time spent by the surgeon using the ultrasound is recorded. If all lesions seen on pre-op imaging were found, the patient does not have the Pathfinder Explorer system applied. If one or more lesions cannot be found, then the Pathfinder Explorer system is calibrated and a tracking device is attached to the ultrasound probe, which the surgeon will use to reattempt localization of the missing tumor. The Pathfinder Explorer system operates in real-time in conjunction with the ultrasound.

Official Title
-----------------
Utility of Intra-operative Image Guidance System for Missing Metastases

Conditions
-----------------
Colorectal Cancer, Metastatic to the Liver

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient has one or more colorectal liver metastases, at least one of which is ≤1.5cm in maximal diameter on pre-operative cross sectional imaging undergoing liver resection and/or ablation Exclusion Criteria: none
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 |
| --- | --- | --- |
| localization rate of liver tumor | estimate the localization rate of Pathfinder to within +/-7%. | 1 year |