linjc16/ctgov huggingface dataset:
Investigating the Absorption, Metabolism and Excretion (AME) of Idalopirdine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigating the absorption, metabolism and excretion of radio labelled single doses of idalopirdine in healthy men.

Official Title
-----------------
Interventional, Open-label, Two Single Dose, Fixed-sequence Study Investigating the Absorption, Metabolism and Excretion (AME) of Idalopirdine Following a Single Oral Dose of Lu AF67708 ([Ethyl-1-14C]-Idalopirdine) and Lu AF67709 ([Benzyl-7-14C]-Idalopirdine) in Healthy Men

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

Intervention / Treatment
-----------------
* Drug: [ethyl-1-14C]-idalopirdine
* Drug: [benzyl-7-14C]-idalopirdine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men aged between 40-60 years (inclusive) BMI in the range 19 and 30 kg/m2 (minimum weight 60 kg) Exclusion Criteria: The subject has previously been dosed with idalopirdine. Other protocol defined inclusion and exclusion criteria do apply

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

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

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

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: Idalopirdine<br>Period I: Initial administration of Lu AF67709 single dose at baseline. Period II: Administration of Lu AF67708 single dose (week 4) | Drug: [ethyl-1-14C]-idalopirdine<br>* 120 mg/2.40 MBq Lu AF67708 ([ethyl-1-14C]-idalopirdine) in one capsule for oral administration, single dose<br>* Other names: Lu AF67708;Drug: [benzyl-7-14C]-idalopirdine<br>* 120 mg/2.40 MBq Lu AF67709 ([benzyl-7-14C]-idalopirdine) in one capsule for oral administration, single dose<br>* Other names: Lu AF67709;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative amounts of radioactivity excreted in urine and faeces (% of dose) |  | 0 to 168 hours | 
| Pharmacokinetic (PK) of idalopirdine and radioactivity in plasma (Cmax, tmax, AUC, t1/2, oral clearance and apparant volume of distribution. (composite outcome measure) | PK parameter: | 0 to 168 hours |
Treatment (Compassionate) Use of Device - PK Papyrus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the clinical use of the PK Papyrus Coronary Stent Graft System, a Humanitarian Use Device (HUD) approved by the FDA under a Humanitarian Device Exemption.

Official Title
-----------------
Treatment (Compassionate) Use of Device - PK Papyrus

Conditions
-----------------
Pseudoaneurysm, Carotid, Pseudoaneurysm

Intervention / Treatment
-----------------
* Device: PK Papyrus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patients with traumatic, dissecting, pseudo, or other wide based aneurysms in non-perforator territories or fistulas of the extracranial or intracranial segments of the internal carotid or vertebral artery. Exclusion Criteria: Patients from special populations including individuals who are not yet adults (infants, children, teenagers). Adults who are cognitively impaired, pregnant women, and prisoners.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PK Papyrus|The PK Papyrus is a balloon mounted stent that will be administered during standard of care treatment of pseudoaneurysms.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pain in Diagnostic Hysteroscopy

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess which factors influence the pain perceived during diagnostic anesthesia-free hysteroscopy.

Official Title
-----------------
Pain in Diagnostic Hysteroscopy: a Multivariate Analysis.

Conditions
-----------------
Pain in Diagnostic Hysteroscopy

Intervention / Treatment
-----------------
* Procedure: Diagnostic hysteroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female gender diagnostic hysteroscopy indication italian-speaking patients Exclusion Criteria: patients who had previously undergone a diagnostic hysteroscopy patients who had been previously undergone to cervical surgery ongoing pregnancy cervical carcinoma pelvic inflammatory disease excessive uterine bleeding performance of an endometrial biopsy during the procedure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal saline<br>Normal saline is a distension media of uterine cavity in diagnostic hysteroscopy. | Procedure: Diagnostic hysteroscopy<br> <br> |
| Active Comparator: Carbon dioxide<br>Carbon dioxide is a distension media of uterine cavity in diagnostic hysteroscopy. | Procedure: Diagnostic hysteroscopy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pain during diagnostic hysteroscopy by Visual Analogue Scale. |  | 5 minutes after the procedure. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VAS, Diagnostic hysteroscopy, Pain, Multivariate analysis, Normal saline, Carbon dioxide
Towards Worldwide Comparability of Visual Acuity Assessment

Study Overview
=================
Brief Summary
-----------------
Purpose of this study is to investigate the agreement, the test-retest reliability of three established and widely used visual acuity tests, to develop a mathematical transformation routine between the results from these three tests, to assess the examinees´ and examiners´ acceptance and to compare the test durations.

Detailed Description
-----------------
Assessment of distant visual acuity is the most frequently used procedure for estimation of visual performance. However, there exist a vast number of markedly differing visual acuity tests worldwide; furthermore there are differing report formats to express acuity. This variety may critically interfere with standardization and comparability of this basic visual test method. Purpose of this study is to investigate the agreement, the test-retest reliability of three established and widely used visual acuity tests, i.e., the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts, a conventional projected distant visual acuity test according to DIN 58220 part 3, and the Freiburg visual acuity test (FrACT), to develop a mathematical transformation routine between the results from these three tests, to assess the examinees´ and examiners´ acceptance and to compare the test durations.

Official Title
-----------------
Towards Worldwide Comparability of Visual Acuity Assessment A Pilot Study Comparing ETDRS Visual Acuity Charts, Projected Landolt Charts and the Freiburg Visual Acuity Test (FrACT) With a View to Developing a Mathematical Transformation Routine Between the Results From These Three Tests

Conditions
-----------------
Comparison of Visual Acuity Tests., ETDRS. FrACT. Landolt Rings.

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of: normal ophthalmological status, opacity of the refractive media, maculopathy, optic neuropathy chiasmal and postchiasmal visual pathway pathologies, amblyopia (deprivation), amblyopia (strabism) Exclusion Criteria: underage person concomitance of different eye-diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| normal ophthalmological status<br> | |
| opacity of the refractive media<br> | |
| maculopathy<br> | |
| optic neuropathy<br> | |
| chiasmal and postchiasmal visual pathway pathologies<br> | |
| amblyopia (deprivation)<br> | |
| amblyopia (strabism)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Neurostimulation in Pudendal Nerve Block

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to check whether the success rate of blind pudendal nerve block in penile surgery can be optimized by the search for a motor response during neurostimulation.

Official Title
-----------------
Neurostimulation in Pudendal Nerve Block: is That Really Necessary?

Conditions
-----------------
Penile Surgery

Intervention / Treatment
-----------------
* Procedure: Pudendal nerve block
* Drug: Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children scheduled for elective penile surgery (hypospadias / circumcision) Non-inclusion Criteria: Association to further peripheral nerve blocks required

Ages Eligible for Study
-----------------
Minimum Age: 6 Months

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

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: Pudendal nerve block<br>Bilateral pudendal nerve block with the administration of 0.1 mL/kg Bupivacaïne 0.5%, regardless of neurostimulation response. | Procedure: Pudendal nerve block<br> <br> Drug: Bupivacaine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve block success | Nerve block success is defined by the absence of 20% increase in heart rate or systolic blood pressure baseline values | 15 minutes |
Peritoneal 1.3-ß-D-glucan for the Diagnosis of Intra-abdominal Candidiasis in Critically Ill Patients (pBDG2)

Study Overview
=================
Brief Summary
-----------------
New rapid diagnostic strategies are warranted in intra-abdominal candidiasis (IAC). A previous retrospective study showed that one measure, the day of the surgery, of peritoneal 1.3-Beta-D-Glucan ≤ 310pg/ml could rule out an IAC. This strategy was independent of the patient underlying conditions and Candida risk factors. This study aimed to confirm these results with a multicenter prospective study

Official Title
-----------------
Prospective Evaluation of 1.3-ß-D-glucan in the Peritoneal Fluid for the Diagnosis of Fungal Peritonitis in Critically Ill Patients

Conditions
-----------------
Intra Abdominal Infections, Candidiasis, Invasive, Peritoneal Candidiasis, Critically Ill

Intervention / Treatment
-----------------
* Diagnostic Test: 1.3 BETA D GLUCAN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: critically ill adult (> 18 yrs old) admitted to ICU for intra-abdominal infection requiring surgery and possible intra abdominal candidiasis Exclusion Criteria: declinate to participate, expected death within the first 24 hours

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 |
| --- | --- |
| CASE (intra abdominal candidiasis)<br>Critically ill patients with a confirmed diagnosis of intra abdominal candidiasis (IAC) Definition of IAC : sterilely collected peritoneal fluid cultures that are positive for Candida spp. as determined by the signs and symptoms consistent with an active infection | Diagnostic Test: 1.3 BETA D GLUCAN<br>* dosage of 1.3 BETA D GLUCAN in the peritoneal fluid obtained during surgery with the β-glucan test (Fujifilm Wako Chemicals, Osaka, Japan)<br>|
| CONTROL (bacterial intra abdominal infection)<br>Critically ill patients with a non candida intra abdominal infection (bacterial peritonitis) | Diagnostic Test: 1.3 BETA D GLUCAN<br>* dosage of 1.3 BETA D GLUCAN in the peritoneal fluid obtained during surgery with the β-glucan test (Fujifilm Wako Chemicals, Osaka, Japan)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of 1.3 BDG in the peritoneal exudate of patient with intra-abdominal candidiasis | Value of 1.3 BDG in the peritoneal exudate in patient with intra-abdominal candidiasis in comparison with non intra-abdominal candidiasis | 1 DAY | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of 1.3 BDG in the serum of patient with intra-abdominal candidiasis | Coefficient of correlation between peritoneal and serum 1.3 BDG in patient with and without intra-abdominal candidiasis | DAY 1 and DAY 3 |
Hemodynamic Measurements in Women With Serious Preeclampsia

Study Overview
=================
Brief Summary
-----------------
This trial is examining hemodynamic measurements in women with serious preeclampsia.

Official Title
-----------------
Hemodynamic Measurements in Women With Serious Preeclampsia

Conditions
-----------------
Preeclampsia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with serious preeclampsia

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

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

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 |
| --- | --- | --- |
| Hemodynamic variations in preeclamptic women |  | days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine output |  | days | 
| thrombocyte count |  | days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac output, Preeclamptic women, systemic vascular resistance, blood pressure
The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy, Prospective, Randomized, Open-label Trial

Official Title
-----------------
The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy, Prospective, Randomized, Open-label Trial

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Device: flexible thoracolumbar brace


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: GMFCS level III, IV, V of the Cerebral palsy 20-45 degree of Cobb's angle Exclusion Criteria: less than 20 degree or more than 45 degree of Cobb's angle Neuromuscular disease including congenital myopathy, spinal muscular atrophy, muscular dystrophy and poliomyelitis Acute lumbar pain Fixed scoliosis

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prospective, single-arm trial<br> | Device: flexible thoracolumbar brace<br>* Subjects would wear the flexible thoracolumbar brace over 18 hours a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of scoliosis | Cobb's angle in the whole spine anteroposterior view of X-ray, before and immediately after, and 6months after wearing FLEXpine brace | 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain of the back (thorax) | Patients check the scale through the visual analog scale | 6 months | 
| change of quality of life (aspect of the parents) | Parent of the patients assessed caregiver experience with neuromuscular disease before and 6-month after wearing FLEXpine brace | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral palsy, Brace, Scoliosis
Prospective and Retrospective Cohort Study to Find New Prognostic Factors and Therapeutic Targets in Patients With Newly Diagnosed or Relapsed Malignant Hematologic Disorder Excluding Acute Leukemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to elucidate the factors which are associated with the diagnosis and predict prognosis and therapeutic targets by collecting specimens of tissue sample, peripheral blood, and bone marrow aspirates at the time of diagnosis or relapse/refractory in patients with malignant hematologic disorders except acute leukemia. This study is eligible for patients who are diagnosed with malignant hematologic disorders except acute leukemia or who will have diagnostic procedure with suspicion of having hematologic malignancy. Prospective cohort is for patients who are not in treatment for hematologic malignancy. Retrospective cohort is for patients who are diagnosed and in treatment.

Conditions
-----------------
Malignant Hematologic Disorder

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients with malignant hematologic disorders except acute leukemia who are diagnosed pathologically according to the revised 2008 WHO classification of tumours of haematopoietic and lymphoid tissue or who will have diagnostic procedure with suspicion of having hematologic malignancy. Any gender and age ≥ 19 years Written informed consent Diagnosed after 2005-01-01 in retrospective cohort group. Exclusion Criteria: Patients who cannot understand or disagree the informed consent Patients who diagnosed with acute leukemia

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of patients with malignant hematologic disorders to examine the new prognostic factors and therapeutic targets |  | 5 years |
Studying Umbilical Cord Blood From African-American Donors

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying umbilical cord blood in the laboratory and gathering information about current and previous pregnancies from African-American umbilical cord blood donors may help doctors learn more about the umbilical cord blood of these donors. PURPOSE: This clinical trial is looking at umbilical cord blood from African-American donors.

Detailed Description
-----------------
OBJECTIVES: To correlate the total nucleated cell yield of cord blood units from African-American cord blood donors with gestational history, maternal history, and delivery information. OUTLINE: This is a multicenter study. Donors complete questionnaires about their demographics, maternal history, gestational history, and delivery. Cord blood units (CBU) are collected in utero and transported to the Stem Cell Processing Laboratory where they are evaluated for CBU volume and cell count (i.e., total nucleated cell yield) and cryopreserved. The study results will then be used to devise future interventional strategies to improve the yield of nucleated cells of CBU.

Official Title
-----------------
Investigation of the Total Nucleated Cell Yield of Cord Blood Units Collected From African-American Donors in Correlation With Gestational and Other Health Variables

Conditions
-----------------
Health Status Unknown

Intervention / Treatment
-----------------
* Other: cryopreservation
* Other: questionnaire administration
* Other: study of socioeconomic and demographic variables


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: African-American participant in the National Marrow Donor Program cord blood collection protocol C-2844 Recruited from the Labor and Delivery Suites of the Detroit Medical Center or its affiliated sites PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: cryopreservation|nan|
|Other: questionnaire administration|nan|
|Other: study of socioeconomic and demographic variables|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between total nucleated cell yield of cord blood units and gestational history, maternal history, and delivery information |  | Within a year | 
| Improvement in total nucleated cell yield of cord blood units from African-American donors |  | Within a year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
health status unknown