linjc16/ctgov huggingface dataset:
Study of Milnacipran for the Treatment of Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
Antidepressants of all varieties represent a common form of therapy for many chronic states including fibromyalgia. The majority of antidepressants increase the levels of serotonin or norepinephrine in the central nervous system. Milnacipran is a dual norepinephrine and serotonin reuptake inhibitor and may be effective in the treatment of fibromyalgia.

Official Title
-----------------
A Phase III Pivotal, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Milnacipran for the Treatment of Fibromyalgia

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Drug: milnacipran hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria Exclusion Criteria: Psychiatric illness Depression Suicidal risk Substance abuse Pulmonary dysfunction Renal impairment Active cardiac disease Liver disease Autoimmune disease Cancer Sleep apnea Inflammatory bowel disease

Ages Eligible for Study
-----------------
Minimum Age: 18 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: milnacipran hydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite responder analysis based on pain and patient global status, with or without physical function. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  |  | 
| Health Assessment Questionnaire (HAQ) Disability Index |  |  | 
| Fatigue, sleep and cognitive assessments |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSRI, milnacipran, fibromyalgia
FLuorescence Cholangiography Using Methylene Blue

Study Overview
=================
Brief Summary
-----------------
Open label prospective, non-randomised proof of principle study assessing the use of methylene blue fluorescence cholangiography.

Official Title
-----------------
FLuorescence Cholangiography Using Methylene Blue

Conditions
-----------------
Bile Duct Injury

Intervention / Treatment
-----------------
* Drug: Intravenous Methylene blue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study. Male or Female, aged 18 years or above. Undergoing laparoscopic cholecystectomy Exclusion Criteria: Patient who is unable or unwilling to give informed consent Known allergy to methylene blue Risk of serotonin syndrome (taking SSRI / G6PD deficiency / previous serotonin syndrome) Significant renal failure Pregnant / planning pregnancy or breastfeeding

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous methylene blue<br> | Drug: Intravenous Methylene blue<br>* Methylene blue fluorescence cholangiography during laparoscopic cholecystectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance of surgeon anatomy definition with fluorescence outline |  | Intraoperative (At end of laparoscopic cholecystectomy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signal to background ratio over time throughout laparoscopic cholecystectomy |  | 0, 10, 20, 30, 40, 50, 60, minutes and at 10 minute intervals thereafter post injection of methylene blue | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic cholecystectomy, Fluorescence
Determination of Ustekinumab Levels in Patients With Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
Observational, prospective, single-center follow-up study carried out with patients from the area of the Virgen de Macarena University Hospital, diagnosed with chronic kidney disease, who started treatment with ustekinumab.

Detailed Description
-----------------
Prospective follow-up observational study carried out with patients from the Virgen de Macarena University Hospital, under treatment with ustekinumab in the induction and maintenance phase in order to determine the cut-off points of the ustekinumab levels between which a clinical remission is expected in patients with inflammatory bowel disease.

Official Title
-----------------
Determination of Ustekinumab Levels in Patients With Crohn's Disease: Use in Clinical Practice

Conditions
-----------------
Crohn Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years. Patients treated with ustekinumab in induction and maintenance phase. They must agree to participate in the clinical study, having previously signed the informed consent. Exclusion Criteria: Any patient who does not meet the inclusion criteria previously described and / or who refuses to participate in the study.

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 |
| --- | --- |
| Cases<br>Patients treated with Ustekinumab. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine breakpoints. | To determine the breakpoints for ustekinumab levels between which clinical remission is expected in patients with inflammatory bowel disease. | Up to 44 weeks. |
Treatment of Elevated Arterial Pulmonary Pressure With Inhaled Iloprost

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if iloprost is effective in the treatment of elevated arterial pulmonary pressure in children with ventilator treated respiratory distress syndrome.

Official Title
-----------------
Treatment of Elevated Arterial Pulmonary Pressure With Inhaled Iloprost

Conditions
-----------------
Persistent Pulmonary Hypertension, Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Drug: iloprost


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elevated arterial pulmonary pressure GA > 24 GW 24-48 hours of age Ventilator treatment Exclusion Criteria: Congenital anomalies Severe hypotension

Ages Eligible for Study
-----------------
Minimum Age: 24 Hours
Maximum Age: 48 Hours

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: iloprost|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation index |  |  | 
| Cardiac output |  |  |
Anemia of Inflammation: Investigation on Impaired Iron Regulation in Acutely Ill Patients and Their Clinical Outcome

Study Overview
=================
Brief Summary
-----------------
Anemia of inflammation (AI), a normochromic, normocytic anemia, associated with abnormal iron utilization, erythropoietin hyporesponsiveness, and decreased red blood cells (RBC) survival is a very common problem in hospitalized patients for acute inflammatory diseases and develops within few days from the onset of illness. Deleterious effects of anemia include increased risk of cardiac related morbidity and mortality in critically ill and older patients. Anemia is mediated by hepcidin, the 25-amino acid polypeptide hormone that is central to iron trafficking. Several studies have been performed on pathophysiology of AI in patients affected by chronic diseases but few explore iron metabolism in humans with acute inflammation. The aim is to develop effective new strategies to detect and manage AI in the setting of acutely ill patients, based on the understanding of iron balance underlying this disorder.

Official Title
-----------------
Anemia of Inflammation: Investigation on Impaired Iron Regulation in Acutely Ill Patients and Their Clinical Outcome

Conditions
-----------------
Anemia of Acute Inflammation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (both): serum C-reactive protein level > 3mg/dL creatinine level < 2mg/dL (clearance > 30%) Exclusion Criteria: any haematological diseases cancer under chemotherapy AIDS (or HIV+) liver cirrhosis genetic hemochromatosis immunosuppressive therapy blood transfusion in the past 30-days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| acute ill patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impact of acute inflammatory state on hemoglobin levels | Hemoglobin levels, Blood Red Cells markers, C-RP and other routinary inflammatory markers on day 1 and day 6 (or 8), IL-1, IL-4, IL-6, IL-10, alpha-TNF, gamma-IFN, GDF-15, erythropoietin and hepcidin on day 1 and on day 6 (or 8) | 6 days - 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impact of acute inflammatory cytokines on hepcidin-driven iron balance and monocytes role in anemia of acute inflammation | serum iron levels, ferritin and transferrin saturation, circulating monocytes and their HAMP mRNA. | 6 days - 8 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepcidin, anemia, acute inflammation, IL-6, cytokines
Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
This is an investigator-initiated clinical trial to analysis melphalan pharmacokinetics in pediatric hematopoietic stem cell transplantation patients.

Official Title
-----------------
Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation

Conditions
-----------------
Hematopoietic Stem Cell Transplantation

Intervention / Treatment
-----------------
* Drug: Melphalan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient who will receive a conditioning regimen including melphalan as a part of hematopoietic stem cell transplantation (HSCT). Age is below 19 at the time of diagnosis of a disease which is HSCT indication Written Study Informed consent and/or assent from the patient, parent, or guardian Exclusion Criteria: Female patients who are pregnant or breast feeding Study treatment would deteriorate patient's disease. The patient may have problems with study participation due to a psychotic disorder. Any condition that would, in the Investigator's judgement, interfere with participation in the study
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: Melphalan<br> | Drug: Melphalan<br>* The subject receives conditioning regimen including melphalan as a part of hematopoietic stem cell transplantation. Dosage of melphalan is 50mg/m^2/day. Infuse Melphalan over 30 minutes.<br>* Other names: Conditioning regimen including melphalan for hematopoietic stem cell transplantation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Melphalan concentration | Analysis: Maximum Concentration observed (Cmax) | pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI | 
| Melphalan concentration | Analysis: Time of Maximum concentration observed (Tmax) | pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI | 
| Melphalan concentration | Analysis: Area Under the Curve | pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI | 
| Melphalan concentration | Analysis: Half lite (T1/2) | pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI |
Evaluation of the Recovery Rate and Postoperative Incontinence of Surgical Fistulas in a Cohort of a Reference Centre

Study Overview
=================
Brief Summary
-----------------
Fistula is a pathology that can be complex and lead to treatment difficulties for the proctologist. The proctologist's objective is to treat the infection (anal fistula and abscess) with the minimum impact on anal continence. Drainage of the fistula pathway(s) and removal of infected tissue during initial surgery are essential. The treatment of upper trans-sphincterial fistulas, i. e. those that span more than half the height of the anal sphincter, poses risks to anal continence. It sometimes requires several times of surgical treatment. The study aim to investigate the fate of all patients treated for anal fistula in an expert team, in terms of impact on healing and anal continence and according to the type of anal fistula, the co-morbidity, the surgical techniques used and the bacterial flora responsible.

Official Title
-----------------
Evaluation of the Recovery Rate and Postoperative Incontinence of Surgical Fistulas in a Cohort of a Reference Centre

Conditions
-----------------
Anal Fistula

Intervention / Treatment
-----------------
* Procedure: pus sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over the age of 18, patient with an anus fistula with indication for surgical treatment Exclusion Criteria: Cutaneous Suppuration, without fistula (e.g., Verneuil disease, boil)

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 |
| --- | --- |
| anal Fistula<br>patient with anal fistula with indication to surgical treatment | Procedure: pus sample<br>* A pus sample from the fistula will be taken by the doctor during this first consultation or, failing that, in the operating room before disinfection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the risk factors, including infectious, of failure of the surgery of the fistula in an expert center | 2 year recovery rate after initial surgery of anal fistula | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anal fistula, anal infection
A Normal Donor Sample Collection Study in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
More than one site will participate in the collection of blood and urine samples from healthy adult subjects. These samples will be used for future testing to serve as aged-matched normal controls and to establish normal reference ranges in the development of new invitro diagnostic devices.

Official Title
-----------------
A Normal Donor Sample Collection Study in Healthy Adults

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Apparently healthy adults (age ≥ 21 years) Provide written informed consent for study participation Exclusion Criteria: Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days; Any known or suspected significant chronic medical conditions (such as diabetes, coronary artery disease, renal insufficiency, hypertension, hypercholesterolemia, chronic inflammatory diseases [e.g., rheumatoid arthritis], cancer, etc); Trauma-related surgery within the last 6 months; Any surgery, hospitalization or institutionalization (such as in a nursing home) during the previous 3 months; Received any blood product transfusion within the previous 2 months; Pregnant women or children; Prisoners or institutionalized individuals; Already provided blood or urine samples for this study.

Ages Eligible for Study
-----------------
Minimum Age: 21 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
-----------------
aged matched normal control samples
Post-Marketing Surveillance of Micardis® (Telmisartan) in Patients With Hypertension

Study Overview
=================
Brief Summary
-----------------
The primary objective of this survey is to prospectively investigate safety and efficacy in patients with hypertension treated with telmisartan in proper use in medical practice over a long period

Official Title
-----------------
Post-Marketing Surveillance of Micardis® (Telmisartan) Special Drug Use-results Survey on Long-term Treatment

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Telmisartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hypertension Exclusion Criteria: Patients with the following conditions Patients with a history of hypersensitivity of this product Women in pregnancy (included the possibility of pregnancy) Patients with severe biliary obstructive disorders or severe hepatic insufficiency
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hypertensive patients<br> | Drug: Telmisartan<br> <br> * Other names: Micardis®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse drug reactions |  | up to 1 year | 
| Incidence of adverse drug reactions | classified by Medical Dictionary for Regulatory Activities (MedDRA) terminology | up to 1 year | 
| Change in Mean systolic blood pressure (SBP) |  | up to 1 year | 
| Change in Mean diastolic blood pressure (DBP) |  | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall assessment of efficacy by investigator on 4-point scale |  | at 3 month, after 1 year | 
| Change in pulse rate |  | up to 1 year |
Intrauterine Contraceptive Device (IUD) Placement at Time of C-Section

Study Overview
=================
Brief Summary
-----------------
This is a pilot study of up to 10 women, which will test the hypothesis that the placement of copper IUDs through the uterine incision at the time of uncomplicated elective C-section is technically feasible and acceptable to women seeking long-term contraception.

Detailed Description
-----------------
Women will be enrolled in this study during late prenatal care. Consent for placement of the IUD will be verified prior to elective C-section. After removal of the placenta, the copper IUD will be placed through the incision at the fundus and the tail strings will be delivered through the cervix. Data will be collected about patient bleeding and possible infection during the immediate postoperative period. The visibility of the strings will be verified at discharge and at 2 and 6 weeks postpartum. Fundal placement of the IUD will be verified by ultrasound at the patient's last visit.

Official Title
-----------------
Acceptability and Technical Feasibility of Insertion of a Copper IUD at Time of Elective C-section: A Pilot Study

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Device: Copper IUD ( ParaGard Intrauterine Contraceptive Device)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant woman Requires elective C-section Desires long-term contraception Exclusion Criteria: Contraindications to copper IUD

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Copper IUD<br>Copper IUD | Device: Copper IUD ( ParaGard Intrauterine Contraceptive Device)<br>* Intraoperative placement of copper IUD at time of C-section<br>* Other names: ParaGard Intrauterine Contraceptive Device;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Retention of IUD |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visibility Within the Vagina of IUD Strings at All Times. |  | At 3 days, 2 weeks and 6 weeks postpartum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postpartum contraception, Copper IUD