linjc16/ctgov huggingface dataset:
Study of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
To assess the effect of a single dose of TrIP on pulmonary function in patients with COPD

Official Title
-----------------
Safety, Tolerability, Pharmacokinetics, and Efficacy of Single Inhaled Administrations of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: trospium chloride inhalation powder (TrIP)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female COPD patients between the ages of 40 and 80 years Smoking history of at least 10 pack years Not currently using (or able to wash out of) any long acting bronchodilators Exclusion Criteria: Candidate on a waiting list for surgery while on study Using long-term oxygen therapy Hospitalization for COPD exacerbation

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 400 mg TrIP<br> | Drug: trospium chloride inhalation powder (TrIP)<br> <br> |
| Experimental: 800 mg TrIP<br> | Drug: trospium chloride inhalation powder (TrIP)<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy (measured by spirometry) of TrIP will be assessed in patients with chronic obstructive pulmonary disease. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD
Pleth Variability Index (PVI) to Predict Fluid Responsiveness

Study Overview
=================
Brief Summary
-----------------
Interventional data collection study to evaluate the ability of pleth variability index (PVI) to predict fluid responsiveness in comparison with other dynamic parameters including pulse pressure variation (PPV) and stroke volume variation (SVV).

Detailed Description
-----------------
No subjects were enrolled into the validation portion of this study.

Official Title
-----------------
Validation of PVI as a Parameter to Predict Fluid Responsiveness

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Device: Pulse CO-Oximeter Sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Scheduled for elective surgery requiring general anesthesia and mechanical ventilation Arterial line and Swan-Ganz catheter placement indicated as part of the scheduled surgical procedure Exclusion Criteria: Patients with surgeries at or around site of sensor placement or skin abnormalities affecting the sensor placement area such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish, or acrylic nails that would prevent monitoring of pulse-oximeter physiological parameters during the study Patients with cardiac arrhythmias Patients with intracardiac shunts

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Subjects<br>All subjects are enrolled into this arm and will receive an investigational pulse CO-Oximeter sensor, including nasal sensors, with the same or similar technology and materials as the Masimo FDA cleared devices and sensors. | Device: Pulse CO-Oximeter Sensor<br>* Investigational Pulse Oximeter Sensor will measure hemoglobin (SpHb), pulse rate (PR), perfusion index (PI), pleth variability index (PVI), oxygen reserve index (ORI), etc.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical utility of PVI | Correlation between PVI and SVV to assess PVI as a predictor for fluid responsiveness. | 1-5 hours |
Study on Thrombosis Therapy in German Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The study aims to document the flow of German patients with cancer and acute deep vein thrombosis from first visit to diagnosis and treatment, the applied diagnostic procedures, and therapy modalities.

Official Title
-----------------
Study on Thrombosis Therapy in German Cancer Patients

Conditions
-----------------
Cancer, Deep Vein Thrombosis, Pulmonary Embolism

Intervention / Treatment
-----------------
* Other: no intervention is being made


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with cancer and acute deep vein thrombosis and/or pulmonary embolism Exclusion Criteria: life expectancy less that 6 months age less that 18 years

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 |
| --- | --- |
| all eligible patients<br>there is only 1 Cohort in which all patients participating in this NIS are included | Other: no intervention is being made<br>* This is a Non-Interventional Study (NIS)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment time on low molecular weight heparin |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient pathways | data collection on patient pathway: who is the referring physician, physician who diagnoses deep vein thrombosis (DVT) | 1 year | 
| risk factors for DVT |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, thrombosis, pulmonary embolism, anticoagulation, low molecular weight heparin
Impact of Diabetes and Glucose Control During Rehabilitation After Stroke

Study Overview
=================
Brief Summary
-----------------
To assess whether patients with diabetes have less clinical improvement during inpatient rehabilitation than those without diabetes and whether hyperglycaemia during rehabilitation is an adverse prognostic indicator.

Detailed Description
-----------------
Patients with diabetes have a higher mortality rate and more severe disability from stroke compared to those without diabetes. Those with hyperglycaemia tend to progress to a larger final stroke size. Diabetes and hyperglycaemia may affect the ability of the patient to clinically improve, independent of the degree of initial impairment. We will perform a retrospective review of medical records of stroke patients admitted to an inpatient rehabilitation unit. We will compare outcomes of changes in disability scales (FIM and Barthel) from admission to discharge, length of stay and hospital events between those with and without diabetes. Amongst those with diabetes, we will also assess whether those with higher mean blood glucose levels during their inpatient rehabilitation stay have worse outcomes.

Official Title
-----------------
Impact of Diabetes and Glucose Control During Rehabilitation After Stroke

Conditions
-----------------
Cerebrovascular Accident, Diabetes, Hyperglycemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inpatient rehabilitation for acute stroke Exclusion Criteria: Medical records unavailable
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 Salbutamol as an Adjuvant Therapy for Pompe Disease

Study Overview
=================
Brief Summary
-----------------
evaluate if beta 2-adrenergic agonist can have adjuvant effect to patients with infantile-onset Pompe disease under enzyme replacement therapy

Official Title
-----------------
Evaluation of Salbutamol as an Adjuvant Therapy for Pompe Disease

Conditions
-----------------
Pompe Disease

Intervention / Treatment
-----------------
* Drug: Salbutamol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirm diagnosis as Pompe disease age 2 years or above under at least 1 year regular recombinant human acid alpha glucosidase, and no dosage/frequency change in recent 3 months Provide inform consent Exclusion Criteria: chronic heart disease such as arrhythmia, cardiomyopathy, cardiac infarction history of seizure history of diabetes mellitus history of hyperthyroidism hypokalemia pregnant allergy to β-agonists under medications including diuretics, digoxin, beta-blockers, etc

Ages Eligible for Study
-----------------
Minimum Age: 2 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: Salbutamol<br>age 2-6 year: 0.1mg/kg tid x 2 weeks, then gradually increase to 0.2mg/kg tid (daily total maximal12mg) age 6-12 year: 2mg tid x 2 weeks, then gradually increase to 4mg tid (daily total maximal 24mg) age 12 year and above: 4mg tidx 2 weeks, then gradually increase to 8mg tid (daily total maximal 32mg) | Drug: Salbutamol<br>* Albuterol Syrup (1mL= Salbutamol 0.4mg, 60ml/bot) VENTOLIN TABLETS 2MG (SALBUTAMOL SULPHATE)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10% decrement of creatinine kinase | measure and compare serum creatinine kinase levels | 6 months | 
| Improvement in 6-minutes walk test | measure and compare 6-minutes walk test | 6 months |
Goodness of Clinical History During Stemi PCI

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm or confute the hypothesis that in patients treated with primary pci is not always possible to collect an adequate medical history, the investigators created a clinical registry in which the investigators collect current or previous medical history relevant to DES utilization , in two distinct times.

Detailed Description
-----------------
GHOST Registry Use of drug-eluting stent (DES) in STEMI is sometimes limited, by the concern that adequate information, relating to the current or previous medical history, can not be obtained due to the patient's critical condition. A less than adequate medical history would expose patients treated with DES to a particular risk in case that an absolute or relative contraindication to the required long-term double antiplatelet therapy is not fully elucidated before DES implantation. To confirm or confute the hypothesis that in patients treated with primary pci is not always possible to collect an adequate medical history, we created a clinical registry in which we collect current or previous medical history relevant to DES utilization , in two distinct times: Time zero in which the medical history collection is taken in the cath-lab during the primary pci Time one in which the second medical history collection is taken 4 days after the index procedure when the patient clinical conditions no longer impede an adequate medical history collection.

Official Title
-----------------
Goodness of Clinical History During Stemi PCI (GHOST)

Conditions
-----------------
Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive patients presenting with STEMI treated with primary or rescue PCI Exclusion Criteria: Patient in cardiogenic shock and all those patients unable to communicate with the doctors at the moment of medical history taking

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 |
| --- | --- |
| STEMI patients treated with PCI<br>Four hundred patients with STEMI treated with primary PCI or rescue PCI. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequacy of medical history collection at the moment of primary pci and 4 days after the index procedure |  | Adequacy of medical history collection at the moment of primary pci and 4 days after the index procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary pci, Stent, Medical Hystory, Antiplatelet therapy, Compliance
Real-world Comparative Effectiveness of Apixaban Versus Vitamin K Antagonist

Study Overview
=================
Brief Summary
-----------------
To obtain a better understanding on the comparative effectiveness of apixaban versus VKA (Vitamin K antagonist) for stroke prevention in patients with NVAF (Non-valvular atrial fibrillation) in a real-life setting.

Official Title
-----------------
Real-world Comparative Effectiveness of Apixaban Versus VKA

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Apixaban
* Drug: Vitamin K antagonist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NVAF will be defined as the occurrence of 2 or more inpatient or outpatient claims with ICD-9 427.31 as the diagnosis code at any time in the patient's data history prior to inclusion Patients will be required to have 180 days of enrollment for the assessment of baseline characteristics CHA2DS2-Vasc (C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years; D: Diabetes mellitus; S2: prior Stroke or TIA or Thromboembolism; V: Vascular disease; A: Age 65-74 years; Sc: Sex category) score ≥2 during the 180 days prior to index apixaban use baseline period Exclusion Criteria: Patients <18 years of age Patients with valvular AF (Atrial fibrillation) Pregnancy Malignant cancers Transient cause of AF Patients with VTE (Venous thromboembolism) (pulmonary embolism or DVT (Deep Vein Thrombosis)) Patients with major surgery defined as hip or knee replacement Prescriptions of OACs (Oral anticoagulants) (apixaban, warfarin, dabigatran, rivaroxaban) before index date Prescription of more than one OAC on the index date Patient with any of the events defined in the composite endpoint

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 |
| --- | --- |
| Apixaban<br>Non-valvular atrial fibrillation patients who were initiated on apixaban for stroke prevention | Drug: Apixaban<br>* As prescribed by treating physicians<br>|
| Vitamin K antagonist<br>Non-valvular atrial fibrillation patients who were initiated on Vitamin K antagonist for stroke prevention | Drug: Vitamin K antagonist<br>* As prescribed by treating physicians<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Hospitalization Events (composite endpoint) |  | Up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-valvular atrial fibrillation (NVAF), Prevention, Stroke
Interchromosomal Insertion Carriers PGT-SR

Study Overview
=================
Brief Summary
-----------------
Interchromosomal insertions (IT) are rare and complex structural rearrangements. Theoretically, the risk to have a child to term with a malformation or mental retardation can reach 50% related to the proportion of unbalanced gametes produced from behavior of chromosomes during meiosis. However, the meiotic segregation of IT has rarely been studied. This study provide an accurate reproductive risk of IT carriers resulting from a combined analysis of Sperm-FISH and preimplantation genetic testing for structural rearrangement (PGT-SR) management of IT carriers.

Official Title
-----------------
Management of Insertional Translocation Carriers for Preimplantation Genetic Testing and the Relevance of Sperm Analysis for Reproductive Risk Estimation.

Conditions
-----------------
Interchromosomal Breakpoint, Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Adult patient whom carrying Insertional translocation in the context of PGT-SR management Exclusion Criteria: - Patient who reject the study protocol
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 |
| --- | --- | --- |
| estimate the IT carrier's reproductive risk | estimate the IT carrier's reproductive risk by investigation of the meiotic segregation of sperm from IT carriers by FISH and evaluate PGT-SR results of male and female IT carriers | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients carriers of Insertional translocation (IT), Several years of miscarriages, Abrotions and primary infertility, Interchromosomal insertion, PGT-SR, Sperm.
Are the Pancreatic Serum Proteins Pancreatic Stone Protein (PSP) and Pancreatitis-Associated Protein (PAP) Predictive for the Development of Sepsis? Retrospective Study in Trauma Patients With Soft Tissue Defects.

Study Overview
=================
Brief Summary
-----------------
Retrospective analysis of PSP- and PAP-serum levels in trauma patients with soft tissue defects and possible correlation with the incidence and onset of infection and sepsis.

Conditions
-----------------
Trauma Patients With Soft Tissue Defects

Intervention / Treatment
-----------------
* Procedure: retrospective Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Trauma patients submitted to the university hospital Zurich, aged 18-65 with soft tissue defects Exclusion criteria: Patients with known immunocompromising illnesses, drug abuse or infectious diseases.

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: retrospective Observation|retrospective Observation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Drug Interaction Study Between AZD3480 and Aripiprazole in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate if AZD3480 and warfarin interact with each other or not, i.e. show the same or altered plasma concentration profiles when co-administered compared to administered alone.

Official Title
-----------------
A Single-Centre, Double-Blind, Randomised, Parallel Group Study of Repeated Oral Doses of AZD3480/Placebo and a Single Dose of Aripiprazole to Evaluate the Pharmacokinetic Interaction Between AZD3480 and Aripiprazole in Healthy Subjects (Phase I)

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: AZD3480
* Drug: Placebo
* Drug: Aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed written informed consent Clinically normal physical findings and laboratory values Exclusion Criteria: Clinically significant illness or clinically relevant trauma within three weeks before the first dose History of clinically significant disease Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD3480 + Aripiprazole | Drug: AZD3480<br>* AZD3480 capsules qd, oral, 22 days<br>Drug: Aripiprazole<br>* single dose on day 5<br>* Other names: Abilify;|
| Experimental: 2<br>Placebo + Aripiprazole | Drug: Placebo<br>* Placebo qd, 12 days<br>Drug: Aripiprazole<br>* single dose on day 5<br>* Other names: Abilify;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK variables |  | Frequent sampling occasions during | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, blood pressure, pulse, safety lab) |  | During the whole treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's disease, AZD3480, Aripiprazole