linjc16/ctgov huggingface dataset:
Efficacy and Tolerability of Lanreotide (Autogel 120 mg) in Patients With Acromegaly

Study Overview
=================
Brief Summary
-----------------
The purpose of the protocol, is to evaluate if lanreotide Autogel 120 mg is effective in the control of Growth Hormone (GH) secretion in patients with active acromegaly.

Official Title
-----------------
Phase III, Multicentre, Open Clinical Study on the Efficacy and Tolerability of a New Slow-release Formulation of Lanreotide (Autogel 120 mg) in Patients With Active Acromegaly

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

Intervention / Treatment
-----------------
* Drug: lanreotide (Autogel formulation), duration of treatment 46-48 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of active acromegaly, defined by serum GH levels above 5 µg/L, absence of reduction of serum GH levels below 1µg/L after oral glucose tolerance test (OGTT) and abnormal IGF-1 values Exclusion Criteria: Patients who have undergone pituitary surgery less than 3 months before selection Patients previously treated with radiotherapy Patients previously treated with somatostatin analogue except for a pre-surgical treatment not longer than 3 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lanreotide (Autogel formulation), duration of treatment 46-48 weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth hormone assessment |  | At every visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin-like Growth Factor 1 (IGF-1) and Acid-Labile Subunit (ALS) assessments |  | At every visit (with the exception of ALS at study inclusion) | 
| Prolactin (PRL) assessment |  | At study inclusion, visit 1 and at the final visit of the study | 
| Lanreotide assessment |  | At every visit | 
| Clinical symptoms |  | At every visit | 
| Quality of life |  | At visit 1 and at the final visit of the study | 
| Tumour size |  | At inclusion and at the final visit of the study | 
| Evaluation of carotid vessels (on an optional basis) |  | At inclusion and at the final visit of the study | 
| Safety assessment evaluated by clinical data |  | At every visit | 
| Safety assessment evaluated by laboratory data |  | At inclusion visit and at the final visit of the study |
Dermal Cumulative Irritant Patch Study

Study Overview
=================
Brief Summary
-----------------
A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of FMX-101 in Healthy Volunteers Using a Cumulative Irritant Patch Test Design

Official Title
-----------------
A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of FMX-101 in Healthy Volunteers Using a Cumulative Irritant Patch Test Design

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

Intervention / Treatment
-----------------
* Drug: FMX-101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males or females who were 18 years of age or older. Were of any Fitzpatrick Skin Type or race, providing the skin pigmentation allowed for discernment of erythema. Exclusion Criteria: Had any visible skin disease at the application site which, in the opinion of the investigative personnel, would have interfered with the evaluation of the test site reaction. Had damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site.

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMX-101<br> | Drug: FMX-101<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of mean cumulative irritation over time for IP versus controls using a dermal irritation numerical equivalent grading tool. |  | 3 weeks |
Simvastatin and Metformin Therapy in PCOS Women. Prospective Randomised Trial.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare effects of statins (simvastatin) and metformin on clinical (menstrual cycle, excessive hair, skin problems), endocrine (androgens), metabolic (lipids, markers of systemic inflammation), and endothelial function parameters in women with polycystic ovary syndrome (PCOS).

Official Title
-----------------
Effect of Simvastatin and Metformin on Clinical, Endocrine, Metabolic and Endothelial Function of Women With Polycystic Ovary Syndrome: Prospective Randomised Trial

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: Simvastatin
* Drug: Simvastatin and Metformin
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PCO - ESHRE/ASRM criteria:oligomenorrhea (<8 spontaneus menses per year) and hyperandrogenism(hirsutism or acne) or hyperandrogenemia(testosterone > 70 ng/ml) normal prolactin, TSH, 17-OH progesterone no evidence of androgen producing malignancy, Cushing's syndrome or acromegaly age 18-40 reliable use of birth control pill for at least 3 months and no plans of pregnancy Exclusion Criteria: elevated creatinine kinase above 2 times upper limit of normal or liver enzymes (transaminase) above 2 times of upper limit of normal use of any following medications: cyclosporine, fibrates niacin,antifungal agents, macrolide antibiotics use of oral contraceptives and other steroid hormones 3 months prior to the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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: Simvastatin|nan|
|Drug: Simvastatin and Metformin|nan|
|Drug: Metformin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum testosterone |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| regularity of menstrual cycle |  |  | 
| serum lutropin |  |  | 
| serum follitropin |  |  | 
| serum lipids |  |  | 
| serum DHEAS |  |  | 
| serum SHBG |  |  | 
| serum insulin |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS, Statin, Metformin, Testosterone, Menstrual cycle, Lipids
A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03526299 In Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate safety and toleration of multiple inhaled doses as well as the time course of PF-03526299 concentration in the blood following dosing by dry powder inhaler.

Official Title
-----------------
A Double Blind (3rd Party Open), Randomised, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Multiple Inhaled Doses Of PF-03526299 In Healthy Male Subjects

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

Intervention / Treatment
-----------------
* Drug: PF-03526299
* Drug: PF-03526299


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects and females of non-childbearing potential between the ages of 21 and 55 years. Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110 lbs). Subjects who had a normal chest X-ray in the previous 6 months prior to Screening Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). A positive urine drug screen. History of regular alcohol consumption exceeding 21 drinks/week for males and 14 drinks/week for females.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-03526299 1.396 mg<br> | Drug: PF-03526299<br>* dry powder for inhalation, 1.396 mg, BID for 14 days<br>|
| Experimental: PF-03526299 4mg<br> | Drug: PF-03526299<br>* dry powder for inhalation, 4 mg, BID for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination. |  | 17 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters: Plasma Day 1: Cmax, Tmax, AUCτau. |  | Day 1 - 17 | 
| Plasma Day 7: Cmax, Tmax. |  | 7 Days | 
| Plasma Day 14: Cmax, Tmax, CL/F, AUCτau, t½, accumulation ratio, time to steady state. |  | 14 Days |
Analgesic Effect of Breastmilk for Procedural Pain in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Breastmilk has a more powerful analgesic effect than oral sucrose to avoid procedural pain in preterm neonates. The objective is to test this hypothesis in a randomized, controlled study using a standardized and validated pain scale (DAN). The sample size is 21 preterm infants in each two groups. The main end point is a reduction of the risk to have a DAN superior to 1 from 80% with oral sucrose to 40% with breastmilk.

Official Title
-----------------
Breastmilk or Oral Sucrose Solution in Preterm Neonates for Procedural Pain: a Randomized, Controlled Study

Conditions
-----------------
Procedural Pain

Intervention / Treatment
-----------------
* Other: Breastmilk
* Other: Oral Sucrose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preterm neonates born before 27 and 29+6 weeks GA blood sampling procedure obtention of parental consent Exclusion Criteria: congenital malformation intravenous continuous analgesia contraindications to feed high grade intracerebral hemorrhage

Ages Eligible for Study
-----------------
Minimum Age: 3 Days
Maximum Age: 10 Days

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sucrose<br>This group will receive oral sucrose for procedural pain | Other: Oral Sucrose<br>* oral sucrose: 0.2 ml one time 1 minute before the painful procedure with a pacifier<br>|
| Experimental: breastmilk<br>this group will receive breastmilk as analgesic product to avoid procedural pain | Other: Breastmilk<br>* Breastmilk: 0.2 ml<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrement from 80 to 40% of frequency of DAN's scale score superior to 1 using breastmilk instead of oral sucrose |  | One time during day 3 or 4 then day 7 to 10 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breastmilk, oral sucrose, analgesia, preterm neonates, Neonates
Additional Chemotherapy After Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the efficacy and safety of additional neoadjuvant chemotherapy with capecitabine during the resting periods in patients with locally advanced rectal cancer.

Detailed Description
-----------------
Neoadjuvant chemoradiotherapy (NCRT) has been used as standard treatment modality in patients with locally advanced rectal cancer (LARC) because of increased local control, enhanced sphincter preservation, and less toxicity.NCRT has enhanced down-staging of tumor and reduced local recurrence. However, survival benefit of NCRT has not been demonstrated and the rate of distant metastasis was still reported as high as 30%. Patients with pathologic complete remission (pCR) after NCRT have shown excellent survival benefit. We inferred that additional chemotherapy during the resting period could enhance the pCR rate. The aim of the present study is to evaluate the safety and efficacy of an additional 4-week chemotherapy with capecitabine after the conventional 6-week NCRT in patients with LARC.

Official Title
-----------------
A Phase II Study of Additional Four-week Chemotherapy With Capecitabine During the Resting Periods After Six-week Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer

Conditions
-----------------
Rectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically proven, locally advanced adenocarcinoma of the rectum an Eastern Cooperative Oncology Group (ECOG) score of 0-2 adequate function of major organs a signed informed consent. Exclusion Criteria: other co-existing malignancy or malignancy within the last 5 years prior to enrollment severe concurrent medical or psychiatric disorders prior RT to pelvis pregnant or lactating patients

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rectal cancer, neoadjuvant chemoradiotherapy, Capecitabine
Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to conduct a clinical trial of two formulations of budesonide (nebulized/swallowed versus viscous/swallowed) in patients with EoE to determine if medication contact time and distribution in the esophagus relates to treatment response. The investigators will also determine if there is systemic absorption of these topical steroids. The investigators hypothesize that tissue and symptom response will correlate with esophageal medication contact time and distribution, and that significant systemic absorption will not be seen.

Official Title
-----------------
Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE): Esophageal Medication Distribution, Treatment Response, and Effect on the Adrenal Axis.

Conditions
-----------------
Eosinophilic Esophagitis

Intervention / Treatment
-----------------
* Drug: inhaled/swallowed budesonide
* Drug: viscous/swallowed budesonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New diagnosis of eosinophilic esophagitis (per 2007 consensus guidelines) Exclusion Criteria: Age < 18 Inability to read or understand English Pregnant or nursing women Previous allergic reactions to steroid medications Current use of systemic steroids

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: inhaled/swallowed budesonide<br> | Drug: inhaled/swallowed budesonide<br>* medication will be nebulized and then swallowed<br>|
| Active Comparator: viscous/swallowed budesonide<br> | Drug: viscous/swallowed budesonide<br>* viscous suspension of budesonide will be swallowed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue Eosinophil Counts | Level of tissue eosinophil counts (measured in number of eosinophils per high-power microscopy field) on esophageal biopsy after treatment | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adrenal Insufficiency | Adrenal insufficiency as measured by a standard cortisol stimulation test (using 0.25 mg cosyntropin IV and baseline and 60 minute post-injection serum cortisol measurements) after treatment. A rise in serum cortisol concentration after to a peak of ≥18 mcg/dL was considered normal; a smaller rise than this was considered adrenal insufficiency. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
eosinophilic esophagitis
A Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens

Study Overview
=================
Brief Summary
-----------------
Radiography of breast specimens is currently the only radiological procedure used to verify removal of microcalcifications and presence of tumor-free margins after breast surgical resection. Ex vivo MRI will be tested for its ability to detect residual tumor tissue not detected by radiography in resected breast tumor specimens and/or its ability to verify tumor-free margins in breast cancer detected by MRI only.

Official Title
-----------------
A Randomized Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens in Evaluating Tumor-free Margins After Surgical Resection of Breast Microcalcifications

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: radiography
* Device: MRI (magnetic resonance imaging)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with malignant breast disease identified by microcalcifications without clinically evident disease Women candidate to breast preserving surgery Exclusion Criteria: Cardiac pacemaker, defibrillators, cardiac monitors Brain stimulators, implantable spinal stimulators Vascular and aneurismal clips Hemostatic clips Infusion pumps Glaucoma drainage implants Metallic foreign body positioned in vital organ of the patients Some heart valves Some vascular access ports, infusion pumps and catheters Permanent contraceptive tubal device Kidney disease

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

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: radiography<br>Arm1: patients undergo mammographic localizations and radiography of the specimen after surgical resection. | Device: radiography<br> <br> |
| Active Comparator: MRI (magnetic resonance imaging)<br>Arm2: patients undergo MRI localization and ex vivo MRI after surgical resection. | Device: MRI (magnetic resonance imaging)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic efficacy of Magnetic Resonance Imaging (MRI) versus radiography in evaluating tumor-free margins in breast cancer specimens | Diagnostic efficacy will be evaluated by statistical analysis | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Local staging of breast microcalcifications, Evaluation of ex vivo MRI for breast malignancies detected by MRI only, breast cancer, MRI, mammography, microcalcifications
Influence of Inspiratory Flow Pattern on Exchange of Carbon Dioxide in Humans Without Primary Lung Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate how inspiratory flow pattern influences CO2 elimination in people without primary lung disease. The hypothesis is that a long mean distribution time, caused by a long postinspiratory pause and high end-inspiratory flow, will promote CO2 exchange in the alveoli.

Official Title
-----------------
Influence of Inspiratory Flow Pattern on Exchange of Carbon Dioxide in Humans Without Primary Lung Disease

Conditions
-----------------
Pulmonary Gas Exchange, Carbon Dioxide

Intervention / Treatment
-----------------
* Other: Altered breath


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No known primary lung disease Exclusion Criteria: Primary lung disease

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Altered breath<br>The group where the investigators alter the inspiratory and expiratory aspects of a ventilated breath. | Other: Altered breath<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carbon dioxide elimination in a ventilator assisted breath. |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood CO2 concentration. |  | 30 minutes |