linjc16/ctgov huggingface dataset:
Growth and Tolerance of Healthy Term Infants Fed Cow's Milk-Based Infant Formulas

Study Overview
=================
Brief Summary
-----------------
This clinical trial will compare the growth and tolerance of infants who consume an investigational cow's milk-based infant formula to those who consume a marketed cow's milk-based infant formula through approximately 4 months of age.

Official Title
-----------------
Growth and Tolerance of Healthy Term Infants Fed Cow's Milk-Based Infant Formulas

Conditions
-----------------
Growth

Intervention / Treatment
-----------------
* Other: Marketed cow's milk-based infant formula
* Other: Cow's milk-based infant formula with added nutrients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton 10-14 days of age at randomization Term infant with birth weight of minimum of 2500 grams Solely formula fed Signed informed consent and protected health information Exclusion Criteria: History of underlying metabolic or chronic disease, anemia, or immune compromise Feeding difficulties or formula intolerance

Ages Eligible for Study
-----------------
Minimum Age: 10 Days
Maximum Age: 14 Days

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Marketed cow's milk-based infant formula | Other: Marketed cow's milk-based infant formula<br> <br> |
| Experimental: Investigational<br>Cow's milk-based infant formula with added nutrients | Other: Cow's milk-based infant formula with added nutrients<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of body weight gain from 14 to 120 days of age |  | 3.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recall of infant formula at each study visit |  | Up to 3.5 months | 
| Body length measured at each study visit |  | Up to 3.5 months | 
| Recall of stool characteristics questionnaire measured at each study visit |  | Up to 3.5 months | 
| Head circumference measured at each study visit |  | Up to 3.5 months | 
| Recall of gastrointestinal tolerance questionnaire at each study visit |  | Up to 3.5 months | 
| Medically confirmed adverse events collected throughout the study period |  | Up to 3.5 months |
Neuropathic in the Acute Post Operative Phase

Study Overview
=================
Brief Summary
-----------------
Investigation of thermal thresholds and sensory mapping to thermal stimuli

Official Title
-----------------
Identification of Neuropathic Pain in the Acute Post Operative Phase Following Thoracotomy

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years old Exclusion Criteria: do not under stand Danish cognitive reduction previous thoracic surgery Pregnant or nursing inability to cooperate to pain scoring

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 |
| --- | --- |
| lung cancer surgery<br>Patients undergoing thoracotomy for lung cancer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | pain intensity | 14 days | 
| quantitative sensory testing (QST) | thermal thresholds assesses via QST | 14 days | 
| Neuropathic pain | is the pain considered neuropathic | 14 days |
To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride capsules (Pulvules) in healthy adult males under fasting conditions.

Official Title
-----------------
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Health Adult Males Under Fasting Conditions Following Administration of a 40 mg Dose

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: Fluoxetine Hydrochloride 20 mg Capsules (Geneva Pharmaceutical, Inc.)
* Drug: Prozac Fluoxetine Hydrochloride 20 mg Capsules (Dista)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Fluoxetine Hydrochloride 20 mg Capsules (Geneva Pharmaceutical, Inc.) | Drug: Fluoxetine Hydrochloride 20 mg Capsules (Geneva Pharmaceutical, Inc.)<br> <br> |
| Active Comparator: 2<br>Prozac Fluoxetine Hydrochloride 20 mg Capsules (Dista) | Drug: Prozac Fluoxetine Hydrochloride 20 mg Capsules (Dista)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 86 days |
GTS21-201 for Alzheimer Disease:GTS-21 Administered Daily for 28 Days to Participants With Probable Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
A Double Blind, Placebo-Controlled Randomized Study to Compare the Safety and Tolerability of GTS-21 (25 Mg TID, 50 Mg TID, 75 Mg TID and 150 Mg TID) When Administered Daily for 28 Days to Participants With Probable Alzheimer's Disease

Detailed Description
-----------------
A Double Blind, Placebo-Controlled Randomized Study to Compare the Safety and Tolerability of GTS-21 (25 Mg TID, 50 Mg TID, 75 Mg TID and 150 Mg TID) When Administered Daily for 28 Days to Participants With Probable Alzheimer's Disease

Official Title
-----------------
A Double Blind, Placebo-Controlled Randomized Study to Compare the Safety and Tolerability of GTS-21 (25 Mg TID, 50 Mg TID, 75 Mg TID and 150 Mg TID) When Administered Daily for 28 Days to Participants With Probable Alzheimer's Disease

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: DMXB-A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: probable Alzheimer Exclusion Criteria: others

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 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

| Intervention/Treatment |
| --- |
|Drug: DMXB-A|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CDR |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADAS-cog |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer, Probable Alzheimer disease
A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if Pegvisomant is more efficacious than Sandostatin LAR Depot in normalizing IGF-I levels in treatment naive patients with acromegaly.

Official Title
-----------------
A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly

Conditions
-----------------
Acromegaly

Intervention / Treatment
-----------------
* Drug: Pegvisomant
* Drug: Sandostatin LAR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of acromegaly IGF-I levels >=1.3xULN (upper limit of normal) at screening No history of radiotherapy or prior treatment with other drugs for acromegaly Minimum of two months must have elapsed post surgery prior to screening Exclusion Criteria: Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or IGF-I concentrations AST/ALT >= 3xULN (upper limit of normal) Pituitary adenoma within 3mm of optic chiasm confirmed by recent MRI Visual field defects (except post surgical stable residual defects) Unable to self administer drug

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pegvisomant|nan|
|Drug: Sandostatin LAR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with normal IGF-1 concentration at Final Visit (Week 52) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary endpoints include: 1.Percentage of patients with normal IGF-I concentration at any visit. 2.Percent change from Baseline of IGF-I at each visit. 3.Percent change from Baseline of IGFBP-3 (IGF binding protein-3) at Week 24 and Final Visit |  |  |
Comparison of Two Rapid Antigen Detection Tests for the Detection of Group-A Streptococcal Pharyngitis in Children

Study Overview
=================
Brief Summary
-----------------
Group A streptococcal (GAS) pharyngitis in children represents a frequent diagnostic challenge in pediatric emergency departments, since isolated signs and clinical prediction rules are insufficient to accurately discriminate between GAS and non GAS infections. Rapid antigen detection tests (RADTs) therefore remain essential, simple and rapid tools, allowing for rapid GAS identification and prompt antibiotic prescription. However, their sensitivity is not optimal. The aim of the present study is to test the accuracy of a new fluorescent immunoassay (Sofia Strep A FIA) using the optical technology for GAS detection in children 3-15 years old with pharyngitis, compared to a standard RADT, using throat culture as the gold standard (or PCR for discrepant results, i.e. negative culture with any positive RADT).

Official Title
-----------------
Comparison of Two Rapid Antigen Detection Tests for the Detection of Group-A Streptococcal Pharyngitis in Children

Conditions
-----------------
Pharyngitis

Intervention / Treatment
-----------------
* Diagnostic Test: Sofia Strep A FIA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient age between 3 and 15 years Clinical diagnosis of pharyngitis McIsaac score ≥2 Exclusion Criteria: Antibiotic treatment in the two weeks preceding the consultation

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Sofia Strep A FIA|Patients who presented with sore throat will be performed throat swab for the new fluorescent immunoasssay (Sofia Strep A FIA), for a standard RADT (Alere Testpack Strep A) and for culture and backup PCR in case of discrepant results.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of the new Sofia Strep A FIA test in children with pharyngitis | Comparison of the sensitivity and specificity of two rapid tests (Sofia StrepA FIA and Alere Testpack Strep A) using standard throat culture as reference. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of the new Sofia Strep A FIA test in children with pharyngitis stratified on the pretest probability of GAS infection (according to McIsaac scores) | sensitivity and specificity of the two tests in relationship to the pretest-probability of GAS infection as measured by the McIsaac score | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GAS, pharyngitis, children, RADT
Trial of Extended Treatment With Liatermin (r-metHuGDNF) Administered by Continuous Intraputaminal (IPu)Infusion to Subjects With Idiopathic Parkinson's Disease Who Have Completed a Previous Trial of Liatermin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine long-term efficacy of continuous IPu liatermin infusion administered with concomitant standard anti-Parkinsonian therapy.

Official Title
-----------------
Multi-Center, Open-Label Trial of Extended Treatment With Liatermin (r-metHuGDNF) Administered by Continuous Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease Who Have Completed a Previous Trial of Liatermin (Protocol 20020168)

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Biological: Liatermin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Completion of the 20020168 protocol

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 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: Liatermin<br>Bilateral continuous infusion of liatermin for up to 24 months. | Biological: Liatermin<br>* Liatermin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in UPDRS |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment emergent and device related adverse events |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bilateral, idiopathic Parkinson's Disease
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Trial to Investigate the Efficacy and Safety of SPM 927 (200mg/Day and 400mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization

Study Overview
=================
Brief Summary
-----------------
Male and female patients between 16 and 70 years of age who are diagnosed with epilepsy with partial seizures and are taking up to 3 medications for this medical condition will take part in this research study at approximately 80 different locations in Australia and Europe. The purpose of this study is to evaluate the effectiveness, safety and tolerability of consistent dosages of study drug (lacosamide) taken orally twice a day for about 4 months. Each patient who qualifies and chooses to participate in the study will receive placebo (inactive drug) or gradually increasing doses of lacosamide (SPM 927) up to the target dose of 200mg/day or 400mg/day. The target dose or placebo will be maintained for 12 weeks. The study clinic visits will include a medical history and physical exam, ECG, blood and urine sample collection, and completion of a seizure diary. Patients who complete the study may enroll in an extension trial and receive active study drug.

Official Title
-----------------
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Trial to Investigate the Efficacy and Safety of SPM 927 (200mg/Day and 400mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization

Conditions
-----------------
Partial Seizures With or Without Secondary Generalization

Intervention / Treatment
-----------------
* Drug: SPM 927


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: partial seizures with or without secondary generalization Exclusion Criteria: subjects received SPM 927 in a previous trial

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 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

| Intervention/Treatment |
| --- |
|Drug: SPM 927|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluation of Analgesia Nociception Index (ANI) During Propofol/Remifentanil and Sevoflurane/Remifentanil Anesthesia

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective randomized study was to evaluate the ability of the new Analgesia Nociception Index ANI, derived by heart rate variability, to detect painful stimulation during either propofol or sevoflurane anesthesia and changing remifentanil concentrations.

Detailed Description
-----------------
Monitoring Antinociception during general anesthesia is still a big challenge in the field and has not become clinical routine yet. Recently, for the Surgical Pleth Index SPI a benefit for the patient in terms of reduction of remifentanil use, less unwanted effects and shorter recovery from anesthesia was reported. However, there are new variables like the ANI that are developed to measure antinociception during anesthesia. In the present study the investigators want to evaluate, whether ANI detects a painful tetanic stimulus during general anesthesia using propofol or sevoflurane and different concentrations of remifentanil.

Official Title
-----------------
Detection of Nociceptive Stimulation by Analgesia Nociception Index (ANI) During Anesthesia With Propofol or Sevoflurane and Varying Remifentanil Concentrations.

Conditions
-----------------
General Anaesthesia

Intervention / Treatment
-----------------
* Procedure: tetanic stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18- 65 years, ASA physical status I or II, elective surgery in general anesthesia planned, written informed consent Exclusion Criteria: pregnancy, history of cardiac arrhythmia, presents of any neuromuscular or neurologic disease, use of CNS-active medication or abuse of alcohol/illicit drugs -

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| propofol/remifentanil<br>patients receive standardized propofol and changing remifentanil concentrations | Procedure: tetanic stimulation<br>* as test stimulus a painful tetanic stimulation is used<br>|
| sevoflurane/remifentanil<br>patients receive standardized sevoflurane and changing remifentanil concentrations | Procedure: tetanic stimulation<br>* as test stimulus a painful tetanic stimulation is used<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
-----------------
Analgesia, Anesthetics, Diagnostic Techniques and Procedures