linjc16/ctgov huggingface dataset:
Quality Register for Geriatric Psychiatry

Study Overview
=================
Brief Summary
-----------------
QualGeP (KVALAP) is a quality register in Viken Research network for Geriatric Psychiatry. The objectives of the register are to enhance our knowledge of old persons with severe psychiatric disorders, and to secure an optimal medical evaluation, treatment and care for these patients. The data in the register will be used for quality assurance and for research. Aims: Quality assurance Further development of our diagnostic and screening tools Contributing to improving the treatment, with and without drugs Contributing to improving the dialogue and collaboration between primary healthcare and hospitals

Detailed Description
-----------------
Data collected: Demographic data Previous and present disorders and use of drugs Data from relatives regarding: the patient's cognition psychiatric health behaviour activities of daily living the stress and care burden of relatives Tests of cognitive functions Methods and duration for treatment Transfer to primary healthcare Possible readmissions

Official Title
-----------------
Quality Register for Geriatric Psychiatry in Viken Research Network for Geriatric Psychiatry

Conditions
-----------------
Geriatric Disorder, Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients submitted to geriatric psychiatry units and their relatives who sign the consent form Exclusion Criteria: Patients and relatives who refuse to sign the consent form

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Geriatric psychiatry<br>Elderly patients with psychiatric disorders in geriatric psychiatry units | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression and cognition | Scores on assessment scales (MADRS, Cornell scale, MMSE) | During admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Geriatric Psychiatry, Quality register, Quality improvement, Quality control, Research elderly patients with psychiatric disorders
Chronic Alcohol and Brain Stress Circuit Response

Study Overview
=================
Brief Summary
-----------------
Alcoholism is among the top three causes of preventable death and disease in the US (Mokdad et al., 2004; Room et al., 2005). Stress plays an important role in the development of alcoholism and in high vulnerability to alcohol relapse. This study will provide a greater understanding of the mechanism by which stress and alcohol consumption interacts to influence development of compulsive alcohol seeking and vulnerability to stress-induced drinking, and the results will have significant implications for the development of new prevention and treatment interventions for alcoholism.

Official Title
-----------------
Chronic Alcohol and Brain Stress Circuit Response

Conditions
-----------------
Stress, Alcoholism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 21-50

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 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 |
| --- | --- |
| Social drinkers<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess differences in reactivity to cue imagery | Physiological measures will be collected (heart rate, blood levels), self-reports of emotional states completed & alcohol taste task performed | 2 years from start of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
social drinkers
Evaluation the Growth Factors(IGF-1,IGFBP-3and HGH)in Patients With Chronic Liver Disease

Study Overview
=================
Brief Summary
-----------------
BACKGROUND The insulin-like growth factor system (IGFs) plays an important role in cell growth and differentiation. Nevertheless, the roles played by insulin-like growth factor-1 (IGF-1), insulin-like growth factor binding protein-3 (IGFBP-3) and human growth hormone (HGH) in the progression of chronic liver disease remain to be elucidated and investigated. METHODS The subjects in the present study included 60 healthy controls, 30 hepatitis patients, 60 liver cirrhosis patients and 60 untreated hepatocellular carcinoma patients. Blood was drawn by venipuncture into Venoject tubes. To find the possible correlations between liver damage and IGFs, serum IGF-1, GH, IGFBP-3 concentration and related biochemical parameters were measured. We used immunoradiometric assay to determine the levels of IGF-1, HGH and IGFBP-3 in serum.

Detailed Description
-----------------
healthy controls:one blood sample (7.5 cc) hepatitis: three blood samples, at admission, at 3rd and 7-10th day of admission liver cirrhosis: two blood samples, at 1-2 years interval (7.5 cc/each session) hepatocellular carcinoma: three blood samples, before, 1 day after and at the 7th day of transcatheter arterial chembolizatiom

Official Title
-----------------
Insulin-Like Growth Factor-1,Insulin-Like Growth Factor Binding Protein-3 and Human Growth Hormone in Serum of Patients With Chronic Liver Disease and Possible Clinical Applications.

Conditions
-----------------
Hepatitis, Liver Cirrhosis, Hepatocellular Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Hepatocellular carcinoma Must be primary Hepatocellular carcinoma and untreament Exclusion Criteria: treatment Hepatocellular carcinoma

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 3:<br>three arms for study | |

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
-----------------
GH,IGF-1, IGFBP-3
A Study to Evaluate the Tolerability, Safety and Pharmacokinetic Characteristics of DA-3803

Study Overview
=================
Brief Summary
-----------------
This is a single-blind, randomized, comparative, phase I study to evaluate the tolerability, safety and pharmacokinetic characteristics of human chorionic gonadotropin between two recombinant hCG products named DA-3803 injection and ovidrel liquid injection, in healthy subjects. The subjects will injected with these two injections at the the 21day-interval of time and their conditions including vital signs, blood, clinical examination will be carefully observed.

Official Title
-----------------
Single-Blind, Randomized, Comparative, Phase I Study to Evaluate the Tolerability, Safety, and Pharmacokinetic Characteristics of Human Chorionic Gonadotropin Between Two Recombinant hCG Products, DA-3803 Injection and Ovidrel Liquid Injection, in Healthy Subjects

Conditions
-----------------
Infertility, Induction of Ovulation

Intervention / Treatment
-----------------
* Drug: T-R (Test-Reference drug)
* Drug: R-T (Reference-Test drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No medical history relating to the alimentary system, liver system, heart system, haematological disease Ideal body weight +/- 20% Exclusion Criteria: acute disease within 28 days medical history that might affect the absorption, distribution, secretion, metabolism of drugs metrectomy surgery desexualization tubal ligation menopause pregnancy not able to use contraception drink alcohol more than 14 units/week smoker who smokes 10 or more cigarettes

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T-R (Test-Reference drug)<br>DA-3803 Injection is injected first and Ovidrel liquid injection is injected after 3-week period | Drug: T-R (Test-Reference drug)<br> <br> * Other names: Drug: Ovidrel liquid injection (Referecne drug);|
| Experimental: R-T (Reference-Test drug)<br>Ovidrel liquid injection is injected first and DA-3803 Injection is injected after 3-week period | Drug: R-T (Reference-Test drug)<br> <br> * Other names: Drug: DA-3803 (Test drug);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration in serum of hCG examined by non-compartmental analysis | Examine the following: Maximum blood concentration Travel time of maximum blood concentration half time t(1/2) Clearance Volume of distribution | 3 weeks |
Application of ATP Infusions in Palliative Home Care

Study Overview
=================
Brief Summary
-----------------
Palliative care in cancer aims at alleviating the suffering of patients. A previous study in patients with advanced non-small-cell lung cancer showed that adenosine 5'-triphosphate (ATP) infusions had a favourable effect on fatigue, appetite, body weight, muscle strength, functional status, quality of life, and survival. Based on these promising results, the present study was designed 1. To evaluate whether the beneficial effects of ATP administration observed in patients with advanced lung cancer would also be present in pre-terminal cancer patients of different tumour types, and 2. To test the feasibility of application of ATP infusions in a home care setting.

Official Title
-----------------
Application of Adenosine 5'-Triphosphate (ATP) Infusions in Palliative Home Care

Conditions
-----------------
Cancer, Palliative Care, Survival, Quality of Life

Intervention / Treatment
-----------------
* Drug: Adenosine 5'-triphosphate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cytologically or histologically confirmed cancer medical treatment options restricted to supportive care a life expectancy < 6 months World Health Organization (WHO) performance status 1 or 2 suffering from at least one of the following complaints: fatigue, weight loss > 5% over the last 6 months, or anorexia Exclusion Criteria: symptomatic angina pectoris symptomatic heart failure any form of atrioventricular (AV) block (assessed by electrocardiogram) life expectancy < 4 weeks concurrent palliative chemotherapy cognitive dysfunction, and other diseases hampering adequate follow up

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br> | Drug: Adenosine 5'-triphosphate<br>* Weekly ATP infusions (in total 8 infusions) during 8 - 12 hours in a maximum dose of 50 mcg/kg.min<br>|
| No Intervention: C<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Physical restriction Fatigue Quality of life |  | 0-8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite Nutritional intake Body height Body weight Triceps skin fold thickness Mid-upper arm circumference Strength of elbow flexor and knee extensor muscles Handgrip strength Process evaluation |  | 0-8 weeks |
A Study of Nopan Treatment of Acute Suicidality

Study Overview
=================
Brief Summary
-----------------
Anecdotal evidence and several clinical studies found the mixed opioid agonist-antagonist Nopan to be an effective antidepressant with a rapid onset of action. It is therefore hypothesized that Nopan may be a novel and quick-acting treatment for acute suicidality. Depression, suicidality, and overall functioning will be assessed before, during and after a four-week Nopan/placebo trial. It is hypothesized that subjects who receive the active drug will show rapid improvements in objective and subjective measures of these variables.

Official Title
-----------------
Phase 3 Study of the Effects of Nopan as add-on Treatment to Antidepressants in Treating Depression and Suicidality

Conditions
-----------------
Suicidality

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suicidal behavior or ideation (BSI>6) Exclusion Criteria: ECT history within the last month psychotic features within the last 3 months history of schizophrenia, substance or alcohol abuse within the last two years benzodiazepine dependence within the last two years any significant systemic illness or unstable medical condition which does not permit inclusion, according to the research physician pregnant women patients who currently suffer from severe impairment or severe dysfunction of liver, kidney, adrenal, gall, closed brain injury, urinary retention or respiratory system.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nopan<br> | Drug: Nopan<br>* Nopan(0.2-1.6 mg/day, starting dose=0.2 mg/day, N=40)<br>* Other names: Subotex;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo in a manner similar to the active comparator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Suicidality as expressed by the score on the BSI |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in depression as measured by the BDI |  | 4 weeks |
BONVIVA(Ibandronate) PMS(Post-marketing Surveillance )

Study Overview
=================
Brief Summary
-----------------
This is an open label, multi-centre, non-interventional post-marketing surveillance.

Detailed Description
-----------------
This is an open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety of ibandronate administered in Korean patients according to the prescribing information.

Official Title
-----------------
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety of BONVIVA(Ibandronate) Administered in Korean Patients According to the Prescribing Information

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Ibandronate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects must satisfy the following criteria at study entry: Subjects diagnosed with osteoporosis in postmenopausal women. Subjects who the investigator believes that they can and will comply with the requirements of the protocol Subjects with no experience of treatment using ibandronate. Subjects who are administered of ibandronate in normal prescription use Exclusion Criteria: Considering the nature of this non-interventional PMS study, there is no strict exclusion criteria set up. The doctors participating this study to enrol the subjects prescribed with ibandronate following the locally approved Prescribing Information. The following criteria should be checked at the time of study entry. According to contraindication on the prescribing information, ibandronate should not be administered to the following patients: Patients with known hypersensitivity to ibandronate or to any of its excipients Uncorrected hypocalcemia Inability to stand or sit upright for at least 60 minutes
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ibandronate<br>The subjects with osteoporosis in postmenopausal women | Drug: Ibandronate<br>* Basically there is no treatment allocation. Subjects who would be administered of ibandronate at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.<br>* Other names: BONVIVA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of adverse event after ibandronate administration |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of unexpected adverse events after ibandronate administration |  | 6 months | 
| The number of serious adverse events after ibandronate administration |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoporosis, ibandronate
Effects of Different Anesthesia on Odor Memory

Study Overview
=================
Brief Summary
-----------------
This study aimed to research the effect of different general anesthesia administration on postoperative smell functions and memory.

Official Title
-----------------
Comparison of the Effects of TIVA and Inhalation Anesthesia Methods on Olfactory Functions and Olfactory Memory

Conditions
-----------------
Smell Functions, Odor Memory

Intervention / Treatment
-----------------
* Diagnostic Test: butanol threshold test and smell identification tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) I-II risk groups operated under elective conditions with general anesthesia requiring intubation operation durations of 40-180 minutes. Exclusion Criteria: intracranial, endocrine or nasal surgery, pregnant cases, those with history of respiratory tract diseases and psychiatric disease, with disorder of odor reception and perception, with smoking and chronic alcohol use, requiring a nasogastric probe

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Group P (n=40) (Propofol),<br> | Diagnostic Test: butanol threshold test and smell identification tests<br>* no additional intervention<br>|
| Group PS (n=40) (Propofol-Sevoflurane),<br> | Diagnostic Test: butanol threshold test and smell identification tests<br>* no additional intervention<br>|
| Group S (n=40) (Sevoflurane).<br> | Diagnostic Test: butanol threshold test and smell identification tests<br>* no additional intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Butanol Threshold Test | threshold detection and odor discrimination | during 24 hour after surgery | 
| Odor Identification Test | odor discrimination | during 24 hour after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smell functions, General anesthesia management, propofol, sevoflurane, odor memory
Why in PACU After Prostastectomy 2016

Study Overview
=================
Brief Summary
-----------------
This study aims to describe the postoperative functions of patients after undergoing open or robotic prostastectomy. Primary endpoints will focus on complications in the post-anaesthesia care unit (PACU) which prevent dischard from PACU to the general ward. This include Aldrete scores and other complications that can be registrered descriptively. Furthermore, the study seeks to compare what influence open versus robotic prostastectomy have on peri- og postoperative complications.

Official Title
-----------------
Perioperative Mechanisms for Postoperative Function - the Case of Prostastectomy

Conditions
-----------------
Perioperative, Enhanced Recovery

Intervention / Treatment
-----------------
* Procedure: Robotic vs open prostastectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histology diagnosis of prostate cancer Surgery intended for removal or staging of prostate cancer: open prostatectomy, robotic prostastectomy, open staging surgery, laparoscopic staging surgery. Exclusion Criteria: Patients with prostate cancer that do not have surgery. Surgery regarding only removal of distant mestatases origined from prostate cancer.

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 |
| --- | --- |
| Robotic vs open prostastectomy<br>One group is operated by open prostatectomy the other by robotic assistance | Procedure: Robotic vs open prostastectomy<br>* robotic minimal invasive surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Complications assessed by aldrete score | up to 7 days |