linjc16/ctgov huggingface dataset:
A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Under the Age of 6 Years

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to assess the safety and efficacy of Replenine®-VF in children enrolled in the study, under the age of six years, with severe haemophilia B.

Official Title
-----------------
An Open Multi-centre Phase III Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients Under the Age of 6 Years

Conditions
-----------------
Haemophilia B

Intervention / Treatment
-----------------
* Biological: Replenine®-VF (High Purity Factor IX)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients under six years of age at the time of entry with severe Haemophilia B at the time of diagnosis without inhibitors to FIX and requiring Factor IX therapy. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Maximum Age: 6 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 |
| --- | --- |
| Experimental: Replenine®-VF<br> | Biological: Replenine®-VF (High Purity Factor IX)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Factor IX Administered per Month (IU/KG) |  | 26 Weeks |
Alimta, Carboplatin and Radiation Therapy for Non Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
To determine the safety of Alimta when used with chemoradiation in inoperable non small cell lung cancer

Detailed Description
-----------------
To determine the maximal tolerated dose (MTD) and toxicities of Pemetrexed (Alimta) when administered concurrently with carboplatin and thoracic radiation therapy. To determine, qualitatively, the occurrence of local tumor responses identified with this regimen.

Official Title
-----------------
A Phase I Study of Premetrexed (Alimta) and Carboplatin and Radiation Therapy in Patients With Inoperable Non Small Cell Lung Cancer.

Conditions
-----------------
Inoperable Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Premetrexed (Alimta)
* Drug: Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unresectable Stage II, IIIB or IV non small cell lung cancer. Evaluable disease on planning CT scan Zubrod 0-1 Weight loss equal to or less than 10% 3 months prior to diagnosis FEV1 greater than 1000cc Adequate hematologic, renal and hepatic functions Exclusion Criteria: Small cell cancer Stage I non small cell cancer Prior chemotherapy or thoracic or lower neck radiatio therapy

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: Drug<br>Carboplatin and Pemetrexed | Drug: Premetrexed (Alimta)<br> <br> Drug: Carboplatin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response and Progression Free Survival |  | Up to five years after study completion |
Influence of Patient Choice of Intrathecal Morphine on Post-cesarean Delivery Pain.

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled study that will place patients into a choice and a no choice group. The choice group will be able to choose between receiving 100 mcg or 200 mcg intrathecal morphine. The no choice group will be randomized to receive either 100 mcg or 200 mcg of intrathecal morphine. Following casarean delivery, pain scores will be measured at 3, 6, 12, 24, and 36 hours.

Detailed Description
-----------------
This randomised controlled study will include pre-operative screening with a 2 simple questionnaires and the patient will be randomised into a choice and no choice groups. The group with the choice will be offered 2 different doses of intrathecal morphine (100, 200 mcg) which they can decide on after being given a standard script explaining advantages and disadvantages of each dose. Following cesarean section patients will be followed up at 3, 6, 12, 24, 36, 48 hours following spinal injection to assess severity of pain, time to first analgesia, total analgesia requirements, treatment of nausea, vomiting and pruritus.

Official Title
-----------------
Influence of Patient Choice of Intrathecal Morphine on Post-cesarean Delivery Pain.

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Other: Drug Dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women age 18-50 with singleton, term gestation fetuses and scheduled for their 1st, 2nd, or 3rd elective CS (not in labor) will be included. Exclusion Criteria: Patient refusal.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Choice Group<br> | Other: Drug Dose<br>* 100 versus 200 mcg IT morphine<br>|
| Active Comparator: No Choice Group<br> | Other: Drug Dose<br>* 100 versus 200 mcg IT morphine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain scores (0-10) and analgesic use (morphine mg-equivalents) between the groups that have analgesic choice vs. no choice and among the actual doses received. |  | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preoperative questionnaire predictor scores versus postoperative pain and analgesic consumption post cesarean delivery. |  | Baseline and day 1 |
Comparison Between Urocortin 2 and Brain Type Natriuretic Peptide

Study Overview
=================
Brief Summary
-----------------
Evaluation of the role of serum urocortin 2 levels in acute decompensated HF patients and their association with clinical and echocardiographic findings. Assessment of the clinical utility of urocortin 2 in monitoring AHF patients. Comparison between urocortin 2 and BNP as a biomarker in AHF patients

Detailed Description
-----------------
Heart failure (HF) is a clinical syndrome with symptoms and/or signs caused by a structural and/ or functional cardiac abnormality and corroborated by elevated natriuretic peptide levels and/or objective evidence of pulmonary or systemic congestion. (1) .The pathophysiology of HF is a complex interplay of genetic and multiple molecular mechanisms (from inﬂammation to hormonal pathways) performing in the composite network of the cardiovascular system environment. (2). Monitoring of biomarkers in HF can be used to make an initial diagnosis, to aid in prognostic stratification, and to identify a patient's response to therapeutic intervention. (3). Natriuretic peptide (NP) concentrations are quantitative plasma biomarkers for the presence and severity of haemo-dynamic cardiac stress and heart failure. (4). That facilitate renal filtration and sodium excretion whilst suppressing the vasoconstrictor sodium, retaining Renin angiotensin aldosterone system and exerting a tonic anti-trophic effect. (5). But the natriuretic peptide levels are significantly affected by weight, the NT- proBNP in obese subjects is much lower than normal weight subjects. (6). Other factors that affect BNP levels including gender, age and renal disease

Official Title
-----------------
Comparison Between Urocortin 2 and Brain Type Natriuretic Peptide as a Biomarker in Patients With Acute Heart Failure

Conditions
-----------------
Urocortin 2

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with acute decompensated heart failure. Exclusion Criteria: Acute coronary syndrome or stroke in the past 3 months. Severe chronic kidney disease. Severe valve disease.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the role of serum urocortin 2 levels | Evaluation of the role of serum urocortin 2 levels in acute decompensated HF patients and their association with clinical and echocardiographic findings. | baseline | 
| Assessment of the clinical utility of urocortin 2 in monitoring AHF patients |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between urocortin 2 and BNP | Comparison between urocortin 2 and BNP as a biomarker in AHF patients(which is more specific for AHF patients ) | baseline |
Art Therapy in Acute Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Randomised, controlled, single-blinded pilot study to assess the efficacy of psychodynamic art therapy in a sample of hospitalized, (sub)acutely psychotic patients with a diagnosis of schizophrenia compared to a group of patients receiving treatment as usual. *Main hypothesis: Art therapy has no impact on clinical symptoms and the course of remission compared to TAU. *Exploratory hypotheses: Art therapy has no influence on quality of life, mentalizing function, self-efficacy and neuroleptic dosage compared to TAU.

Official Title
-----------------
Art Therapy for Symptom Reduction in Acute Schizophrenia - a Randomised Controlled Trial (Kunsttherapie Zur Symptomreduktion Bei Akuter Schizophrenie - Eine Randomisierte Kontrollierte Pilotstudie)

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Behavioral: psychodynamic art therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of schizophrenia according to DSM-IV-TR age 18-64 yrs sufficient German language competency written informed consent Exclusion Criteria: axis-I mental disorders other than schizophrenia comorbid antisocial personality disorder, relevant substance abuse, relevant severe somatic disease acute suicidal tendencies or aggression incapability to tolerate group settings

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: art therapy<br>12 sessions of art therapy / 6 weeks | Behavioral: psychodynamic art therapy<br>* 2 sessions à 1.5 hrs /week, intervention duration 6 weeks<br>|
| No Intervention: TAU<br>treatment as usual / 6 weeks | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Positive and Negative Syndrome Scale (PANSS-) scores | assessment of change of schizophrenic positive, negative and general symptom scores | weeks 0, 6, 12 | 
| safety measures | number of participants with adverse events | weeks 0, 6, 12 | 
| Change in Calgary depression Scale (CDS-) scores | assessment of change of depressive symptoms in schizophrenic patients as reflected by CDS-scores | weeks 0, 6, 12 |
Blastocyst Culture Using Time-lapse in Good Prognosis IVF Patients and Elective Single Embryo Transfer

Study Overview
=================
Brief Summary
-----------------
Choosing the best embryo for transfer has become the major challenge in in vitro fertilization (IVF). Morphology alone is obviously not enough and time-lapse incubation has added embryo development kinetics as another selection criterion. This study was designed to select for the top blastocyst to be replaced, while increasing the pregnancy chance, with the local legislation regulating the number of embryos to be transferred and to establish a morphokinetic standard to be used in our clinical setting.

Official Title
-----------------
Blastocyst Culture Using Time-lapse in Good Prognosis IVF Patients and Elective Single Embryo Transfer

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Device: Embryoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients in their first or second ART treatment cycle no recurrent spontaneous abortions age<35 years BMI<28 kg/m2 ≥8 oocytes retrieved Exclusion Criteria: severe endometriosis polycystic ovary syndrome hydrosalpynx uterine pathology severe male factor (presenting less than 5 million motile sperm cells in total in the ejaculate) very severe morphological sperm defects (mainly globozoospermic or macrocephalic samples)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional incubation<br>Five-day embryo culture in conventional incubators | |
| Active Comparator: Embryoscope<br>Five-day embryo culture in embryoscope which is an incubator with a built-in camera | Device: Embryoscope<br>* Five-day embryo culture in embryoscope which is an incubator with a built-in camera<br>* Other names: Time-lapse monitoring of human embryos in Embryoscope;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blastocyst formation rate |  | 5th day of embryonic development | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Clinical pregnancy was defined as the presence of a gestational sac detected on ultrasound 3 weeks after the first βhCG test, which was performed 14 days after oocyte retrieval. | 7th week of pregnancy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blastocyst transfer, eSET, Time-lapse, morphokinetics
Healthy Lifestyle in Adults With Attention Deficit Hyperactivity Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand the relationship between ADHD and the overall health of someone with ADHD. People who have ADHD have trouble paying attention, concentrating, organizing, and planning. They may have trouble in school, at work, and at home. The investigators are interested in finding out whether these difficulties have had any influence in the past, current, or future health problems of someone with ADHD. About 100 people with ADHD and 100 people without ADHD will take part in this research study, all through Massachusetts General Hospital (MGH).

Official Title
-----------------
Healthy Lifestyle in Adults With ADHD

Conditions
-----------------
ADHD, Attention Deficit Hyperactivity Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ADHD Subjects Signed written informed consent to participate in the study. Age: 18 - 60 (inclusive). Current diagnosis of DSM-IV ADHD by structured interview. Late age of onset acceptable for participation provided ADHD symptoms meet full criteria currently. Control Subjects Signed written informed consent to participate in the study. Age: 18 - 60 (inclusive). Subjects must have <3 symptoms in each domain (Inattention and Hyperactive/Impulsive) and <5 total symptoms in both domains on the DSM-IVADHD module of the structured interview. Exclusion Criteria: Diagnosis of any psychotic disorder or Autism. Mental impairment as evidenced by a Full Scale I.Q. less than 80. Major sensorimotor handicaps such as deafness or blindness. Subject currently taking antipsychotic medication or mood stabilizers. Inadequate command of the English language.

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 |
| --- | --- |
| 1<br>Adults with ADHD | |
| 2<br>Healthy adults without ADHD | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of ADHD and control subject health habits will be assessed by subject-rated questionnaires and health measures, such as vital signs and blood draw results. |  | 1 time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADHD, health, healthy lifestyle
Study of Escitalopram in the Treatment of Specific Phobia

Study Overview
=================
Brief Summary
-----------------
This pilot study is designed to assess the efficacy of escitalopram in the treatment of specific phobia in adult outpatients.

Detailed Description
-----------------
This double-blind placebo-controlled pilot trial study is designed to assess the efficacy of 12 weeks of escitalopram vs. placebo in the treatment of specific phobia in adult outpatients. It is hypothesized that escitalopram is safe and effective in the treatment of specific phobia.

Official Title
-----------------
Placebo-Controlled Pilot Study of Escitalopram in the Treatment of Specific Phobia

Conditions
-----------------
Phobic Disorders

Intervention / Treatment
-----------------
* Drug: Escitalopram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 18-65 years of age DSM-IV criteria for specific phobia according to the MINI For women of childbearing potential, a negative serum pregnancy test at screening Written informed consent Exclusion Criteria: Any current primary DSM-IV diagnosis other than specific phobia History of DSM-IV substance abuse or dependence within the last months Lifetime history of bipolar I disorder, schizophrenia or other psychotic disorder, mental retardation, or other pervasive developmental disorder or cognitive disorder due to a general medical condition Suicide risk or serious suicide attempt within the last year Clinically significant laboratory or EKG abnormality or unstable medical condition For women of childbearing potential, unwillingness to use an acceptable form of contraception during the study Subjects needing concurrent use of psychotropic medications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response based on a criterion of 50% or greater reduction in the Marks Main Phobia Questionnaire and Marks Fear Questionnaire from baseline |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response based on CGI-I category |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
specific phobia, anxiety, SSRI, clinical trial, escitalopram
Biomarkers of Aneurysm Wall Strength

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify possible in vivo biochemical and biological markers related to aortic wall strength.

Detailed Description
-----------------
Rupture of an Abdominal Aortic Aneurysm (AAA) is potentially lethal. prophylactic surgical repair is therefore warranted when the risk of rupture exceeds the risk of complications following surgery. Aneurysm rupture occurs when the forces (stress) acting on the aneurysm wall surpass aneurysm wall strength. Information on both wall stress and strength might therefore improve rupture risk assessment and patient selection for prophylactic repair. Although aneurysm wall stress calculations are possible, no in vivo method exists to determine aneurysm wall strength. This study was designed to identify possible biomarkers of aneurysm wall strength

Official Title
-----------------
Biological and Biochemical Markers of Aneurysm Wall Degradation; Towards Non-Invasive Wall Strength Analysis.

Conditions
-----------------
Abdominal Aortic Aneurysm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient scheduled for transabdominal aortic surgery Exclusion Criteria: Patient characteristics and aneurysm anatomy suitable for endovascular repair Previous aortic surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| 1<br>Patients scheduled for elective conventional aneurysm repair | |
| 2<br>Patients scheduled for emergent conventional aneurysm repair | |
| 3<br>Patients scheduled for aortic bypass surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aneurysm wall strength |  | Post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extra Cellular Matrix components (Glucoaminoglycans) |  | post-operative | 
| Biochemical blood analysis |  | post-operative | 
| MMP content |  | post-operative | 
| Degree of inflammation |  | Post-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aneurysm, Rupture