linjc16/ctgov huggingface dataset:
Second Transplantation for Graft Failure

Study Overview
=================
Brief Summary
-----------------
Graft failure is a lethal complication after allogeneic stem cell transplantation, which often need a salvage transplantation. However, the current outcome of second transplantation for graft failure is far from satisfactory. We performed a prospective single-arm study to investigate the safety and efficacy of a novel regimen.

Official Title
-----------------
Second Transplantation for Graft Failure After First Allogeneic Stem Cell Transplantation

Conditions
-----------------
Graft Failure, Stem Cell Transplant Complications

Intervention / Treatment
-----------------
* Other: second allogeneic stem cell transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: graft failure after first allogeneic stem cell transplantation no active infection or GVHD or severe organ dysfunction sign written informed consent Exclusion Criteria: active infection, GVHD, organ failure expected life < 28 days
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: intervention arm<br>second allogeneic stem cell transplantation | Other: second allogeneic stem cell transplantation<br>* Change another donor conditioning regimen: FLU/CY/anti-CD25 moAb<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| engraftment | Engraftment of neutrophils was defined as the first of 3 consecutive days when the absolute neutrophil count achieved 500/uL. | 28 days after second transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TRM at 28 day | treatment-related mortality(TRM) was defined as death from any cause other than relapse. | 28 days after second transplantation | 
| TRM at 100d | treatment-related mortality(TRM) was defined as death from any cause other than relapse. | day 100 after second transplant | 
| Overall survival at 100d | Overall survival at 100d | day100 after second transplantation |
Gestational Diabetes: the Prevention

Study Overview
=================
Brief Summary
-----------------
To assess the effectiveness of an exercise program developed during pregnancy (land/aquatic activities) aerobic and muscular tonification, on control to the prevention to Gestational Diabetes. And to assess if excessive maternal weight gain is an influence in the diagnostic.

Detailed Description
-----------------
A clinical, randomized controlled trial was used. 342 pregnant women without obstetric contraindications accepted informed consent for inclusion in the study. Finally, 257 were studied, 101 in intervention group (IG, n= 101) and 156 in control group (GC, n= 156). A physical exercise program three times per week during pregnancy was developed. The duration of session was 60 minutes and 50 minutes in land and water, respectively.

Official Title
-----------------
Gestational Diabetes. The Rol of Exercise in the Prevention

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Behavioral: Exercise group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy pregnant women At week 8-14 Adherence 80% (minimum) until the end of pregnancy Exclusion Criteria: Contraindications appointed by American College of Obstetricians & Gynecologists (ACOG) No adherence

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise group<br>Three sessions per week: Supervised exercise program | Behavioral: Exercise group<br>* Combined two land aerobic sessions and one aquatic activities session<br>|
| No Intervention: Control<br>Sedentary pregnant women | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevention gestational diabetes | Oral glucose tolerance test (OGTT) | weeks 24-30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal weight gain | Maternal weight gain above guidelines recommendations by Institute of Medicine and National Research Council (IOM) | weeks 40-42 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy, exercise, gestational diabetes
Intra-operative PET-CT: a Novel Approach to Determine Excision Margins in Lumpectomy Breast Cancer.

Study Overview
=================
Brief Summary
-----------------
Examination of the feasibility of intra-operative pet CT to detect surgical margins in breast conservative surgery to prevent re-excision.

Official Title
-----------------
Intra-operative PET-CT: a Novel Approach to Determine Excision Margins in Lumpectomy Breast Cancer.

Conditions
-----------------
Breast Cancer Female, Breast Neoplasms

Intervention / Treatment
-----------------
* Diagnostic Test: PET CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • female and 18 years of age or older diagnosed with an early-stage (T1 or T2, and N0 or N1; according to the TNM-classification) invasive breast cancer eligible for breast conserving surgery Exclusion Criteria: • Pregnancy or lactation Diabetes Multifocal tumor disease Diagnosis of inflammatory breast cancer Appointment at the nuclear medicine department for 18F-FDG administration would result in a unacceptable delay of surgery Subject has had exposure to ionizing radiation of more than 1 mSv in other research studies within the last 12 months Subject has recently (<60 days) or is simultaneously participating in another clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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: braeast cancer<br>breast cancer patients | Diagnostic Test: PET CT<br>* measurement of surgical margins during lumpectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| investigate the ability of (micro)PET/CT to evaluate the excision margins and determine negativity of these margins, as compared to the gold standard of sectional histopathological evaluation. | study the feasibility of PET/CT | 2 year |
Post Marketing Observational Study in Patients With Pulmonary Arterial Hypertension

Study Overview
=================
Brief Summary
-----------------
To investigate the long-term safety and effectiveness of Adcirca (tadalafil) in Pulmonary Arterial Hypertension (PAH) patients in the clinical practice -focused topics- To evaluate the incidence of adverse events for the patients with long-term use To evaluate the incidence of adverse events of decreased blood pressure, bleeding (including uterine hemorrhage), visual disturbance and sudden hearing loss.

Official Title
-----------------
Safety and Effectiveness of Adcirca (Tadalafil) in Japanese Patients With Pulmonary Arterial Hypertension: Open-label, Non-interventional Observational Study in Japan

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: tadalafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with PAH receiving Adcirca Exclusion Criteria:Patients who meet the criteria of contraindication patients with hypersensitivity to tadalafil patients who are using any form of organic nitrate patients with severe renal impairment patients with severe hepatic impairment patients taking strong inhibitors of CYP3A4 patients taking strong inducers of CYP3A4

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Patients prescribed Adcirca<br>all patients prescribed Adcirca during study period | Drug: tadalafil<br>* prescribed in accordance with usual clinical practice<br>* Other names: Cialis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse events related to decreased blood pressure, bleeding, visual disturbance and sudden hearing loss. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walk distance change from baseline |  | 2 years | 
| World Health Organization (WHO) functional class change from baseline |  | 2 years | 
| Survival time |  | 2 years | 
| Pulmonary arterial pressure change from baseline |  | 2 years | 
| Score change of Euro Quality of Life (EQ-5D) from baseline |  | 2 years |
Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

Study Overview
=================
Brief Summary
-----------------
A study to evaluate three doses of aripiprazole versus placebo in patients with an acute episode of schizophrenia

Official Title
-----------------
A Placebo-Controlled Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women, ages 18 and older, with a worsening of schizophrenia symptoms over the past three months

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Aripiprazole<br>* Tablets, Oral, 2mg, Once daily, 6 weeks.<br>* Other names: Abilify;|
| Active Comparator: 2<br> | Drug: Aripiprazole<br>* Tablets, Oral, 5mg, Once daily, 6 weeks.<br>* Other names: Abilify;|
| Active Comparator: 3<br> | Drug: Aripiprazole<br>* Tablets, Oral, 10mg, Once daily, 6 weeks.<br>* Other names: Abilify;|
| Placebo Comparator: 4<br> | Drug: Placebo<br>* Tablets, Oral, 0mg, Once daily, 6 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change at endpoint in schizophrenia rating scale |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Improvement scale at endpoint and time to response |  |  |
Ambu Aura GainTM Guided vs Non Guided in Edentulous Ambu Aura GainTM Without Gastric Tube in Endontolous Patient

Study Overview
=================
Brief Summary
-----------------
The Ambu® Aura GainTM is a relatively new 2nd generation Supraglottic Airway Device (SGA) with a second port, providing gastric access to drain gastric content and air and it has an intergrated bite-block that helps avoiding rotation of the SGA. It has been described and it is known from daily routine, that SGA in edentulous patient provide inferior oropharyngeal leak pressure (OLP). The aim of the study is to evaluate if the placement of a gastric tube through the second orifice leads to better OLP and lowers the number of intervention needed for replacing the SGA. The study also evaluates the OLP after 15 minutes and after 30 minutes.

Official Title
-----------------
Comparison of the Ambu Aura GainTM With Gastric Tube Versus the Ambu Aura GainTM Without Gastric Tube in Endontolous Patient

Conditions
-----------------
Oropharyngeal Leak Pressure

Intervention / Treatment
-----------------
* Device: Gastric Tube
* Device: No gastric Tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I - 3 Signed informed consent Age 18 - 90 years Edentolous (or partial) patients Patients scheduled for elective surgery Exclusion Criteria: Patients with a known or predicted difficult airway Patients with anatomical disorders in the upper airway, the oesophagus or the trachea Patients at risk for aspiration Body mass index (BMI) > 40 kg/m2

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ambu Aura Gain TM with gastric tube<br> | Device: Gastric Tube<br>* SGA is inserted with a gastric tube as guide for insertion<br>|
| Other: Ambu Aura Gain TM without gastric tube<br> | Device: No gastric Tube<br>* SGA is inserted without a gastric tube as guide for insertion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oropharyngeal Leak Pressure | after insertion | immediately after insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oropharyngeal Leak Pressure | after 15 minutes | 15 minutes | 
| Oropharyngeal Leak Pressure | after 30 minutes | 30 minutes |
Transcriptomics Signature of Anti Vaccinia Memory B Cells

Study Overview
=================
Brief Summary
-----------------
Analyse the transcriptomic signature of anti vaccinia memory B cells at a short time after vaccination as compared to the signature already established in long-lived memory B cells.

Official Title
-----------------
Transcriptomics Signature of Anti Vaccinia Memory B Cells in Healthy Individuals at a Short Time After Vaccination

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy donors vaccinated against smallpox Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| signature of anti vaccinia long-lived memory B cells |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immunological memory
Treatment of Childhood Social Phobia

Study Overview
=================
Brief Summary
-----------------
This 4-year study will compare the long-term effectiveness of behavioral treatment, fluoxetine (Prozac®), and placebo for treatment of social phobia in children and adolescents.

Detailed Description
-----------------
Social phobia affects 3-5 percent of children, and prevalence rises with age. Youth with social phobia fear many activities that are part of everyday life and suffer from problems such as headaches or stomachaches, panic, avoidance, general anxiety, depression, loneliness, and a very restricted range of social relationships. Recent findings indicate a new psychosocial treatment called Social Effectiveness Therapy for Children (SET-C) is effective in treating children ages 8-11, resulting in reduced emotional distress and improved social functioning. Treatment effects have been maintained for up to 6 months. This study will examine SET-C in children ages 8-15. Because available data suggest that the drug fluoxetine is a promising treatment, SET-C will be compared to fluoxetine in this trial. Durability of treatment will be monitored over a 1-year follow-up period.

Official Title
-----------------
Treatment of Childhood Social Phobia

Conditions
-----------------
Social Phobia

Intervention / Treatment
-----------------
* Behavioral: Social Effectiveness Therapy for Children (SET-C)
* Drug: Fluoxetine
* Drug: Pill Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of social phobia Exclusion Criteria: Pervasive developmental disorders (PDD) Schizophrenia Major Depression IQ of less than 80 Medical conditions contraindicating use of fluoxetine

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 16 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Social Effectiveness Therapy for Children<br>Social Effectiveness Therapy for Children includes social skills training, peer generalization experiences and exposure therapy | Behavioral: Social Effectiveness Therapy for Children (SET-C)<br> <br> |
| Experimental: Fluoxetine<br>Fluoxetine given in 10mg doses, up to 40 mg as tolerated | Drug: Fluoxetine<br> <br> |
| Placebo Comparator: Pill placebo<br>Capsules identical to fluoxetine given in 10 mg. doses up to 40 mg. | Drug: Pill Placebo<br> <br> |

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
-----------------
Phobic Disorders, Mutism
A Study to Compare the Safety, Tolerability, and Pharmacokinetics of CTP-692 Versus D-serine in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety, tolerability and pharmacokinetic (PK) profile of CTP-692 vs D serine.

Official Title
-----------------
A Randomized Single Dose Crossover Comparison of the Safety, Tolerability, and Pharmacokinetic Profile of CTP-692 Versus D-Serine

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: CTP-692
* Drug: D-Serine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must give written and informed consent and any authorizations required by local law. Must have a body mass index (BMI) between 18 kg/m2 and 32 kg/m2, inclusive Exclusion Criteria: Screening laboratory measurements outside the normal range associated with potential risk for the treatment under investigation at screening and/or prior to the first dose of study drug Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen or hepatitis C virus antibody History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal (GI) conditions Positive drug or alcohol test at screening or prior to the first dose of study drug

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTP-692<br> | Drug: CTP-692<br>* Single oral dose<br>|
| Active Comparator: D-Serine<br> | Drug: D-Serine<br>* Single oral dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of AEs in participants as a measure of safety and tolerability. |  | 7 days | 
| Measurement of CTP-692 exposure in plasma |  | 48 hours |