linjc16/ctgov huggingface dataset:
Study of the Effects of Muscular Activity on Iron Metabolism

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the effect of muscular exercise on iron metabolism in healthy volunteers. Fourteen healthy male subjects will have to pedal on an ergocycle for 45 minutes, and urine and blood samples will be collected regularly to measure hemojuvelin, hepcidin, iron and transferrin levels.

Detailed Description
-----------------
Hemojuvelin has been described as interfering with hepcidin, a key regulator of iron homeostasis. Hemojuvelin is mainly produced by muscle, and the relationship between exercise and iron metabolism can be questioned about. The aim of this study is to evaluate the effect of muscular exercise on iron metabolism in healthy volunteers. Fourteen healthy male subjects will be investigated at two periods according to a cross-over design after: 45 minutes of exercise on the ergocycle; and no physical exercise. Urine and blood samples will be collected at both periods regularly to measure hemojuvelin, hepcidin, iron and transferrin levels.

Official Title
-----------------
Study of the Effects of Muscular Activity on Iron Metabolism: A Pilot Study on Healthy Volunteers

Conditions
-----------------
Iron Overload, Iron Deficiency

Intervention / Treatment
-----------------
* Behavioral: 45 minute exercise on ergocycle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male individuals aged between 18 and 40 years old Body mass index (BMI) between 18 and 25 Normal at clinical examination Normal biological variables Written informed consent Exclusion Criteria: Mutation C282Y of the HFE gene Iron metabolism abnormality Inflammatory syndrome Chronic pathology or ongoing treatment Tobacco smoking, alcohol consuming more than 30g/day History of transfusion or blood-giving within 3 months Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: 45 minute exercise on ergocycle|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of urinary hepcidin |  |  | 
| Pharmacokinetics of blood hemojuvelin |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of urine and blood iron, transferrin, interleukin-6 (IL-6) and ferritin |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iron, Hepcidin, Hemojuvelin, Healthy volunteers
Efficacy and Safety Study of Human-cl rhFVIII in PTPs With Severe Hemophilia A

Study Overview
=================
Brief Summary
-----------------
This study will determine the efficacy of human-cl rhFVIII in previously treated patients with severe hemophilia A during prophylactic treatment, treatment of bleeding episodes and in surgical prophylaxis.

Official Title
-----------------
Clinical Study to Investigate the Efficacy, Safety, and Immunogenicity of Human-cl rhFVIII in Previously Treated Patients With Severe Hemophilia A

Conditions
-----------------
Severe Hemophilia A

Intervention / Treatment
-----------------
* Biological: recombinant Factor VIII


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe hemophilia A ((FVIII:C <= 1%) Male subjects >= 12 years of age Previously treated with FVIII concentrate, at least 50 EDs Immunocompetent (CD4+ count > 200/ul) Negative for anti- HIV; if positive, viral load < 200 particles/u; or <400,000 copies/mL Exclusion Criteria: Other coagulation disorder than hemophilia A Present of past FVIII inhibitor activity (.= 0.6 BU) Severe liver and kidney disease Receiving of scheduled to receive immuno-modulating drugs

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: human cl-rhFVIII<br> | Biological: recombinant Factor VIII<br>* intravenous infusion of factor FVIII every other day.<br>* Other names: human-cl rhFVIII;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Assessment After a Total of at Least 50 EDs Per Subject at the End of the Study at 6 Months | Frequency of spontaneous breakthrough bleeds/months under prophylactic treatment. | At least 50 Exposure Days and at least 6 months | 
| Efficacy of Treating Bleeding Episodes | At the end of a bleeding episode, efficacy was assessed as: Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8-12 hours after an infusion requiring up to 2 infusions for complete resolution Moderate: Probable or slight beneficial effect within approximately 12 hours after the first infusion requiring more than two infusions for complete resolution None: No improvement within 12 hours, or worsening of symptoms, requiring more than 2 infusions for complete resolution Efficacy was rated | After each bleeding episode, up to 6 month |
Perinatal Diagnosis of GIT Anomalies

Study Overview
=================
Brief Summary
-----------------
fetal gastro intestinal abnormalities can be accurately diagnosed in second trimester

Detailed Description
-----------------
prenatal diagnosis of these anomalies allows for early postnatal interventions and implementation of treatment options

Official Title
-----------------
Perinatal Diagnosis of Fetal GIT Anomalies

Conditions
-----------------
Fetal Anomalies

Intervention / Treatment
-----------------
* Diagnostic Test: ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women either primi or multigravida pregnant in 18- 24 weeks Exclusion Criteria: first trimester pregnant ladies

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: ultrasound|second trimester us scan will be made to pregnant women|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants who will be diagnosed to have GIT anomalies | GIT anomalies that will be diagnosed by US and confirmed postnatal and managed operatively | within 5 moths |
The Role of Muscular Ultrasound in Predicting Weaning Success

Study Overview
=================
Brief Summary
-----------------
When attempting to wean a patient from the ventilator, even if he/she passes the spontaneous breathing test, 10-20% of the time extubation failure occurs and the patient is reintubated. When the patient is reintubated the mortality rate increases and the length of intensive care unit stay is also increased. It is vital to intensively assess the patient before extubation and correctly predict extubation success. Muscular ultrasound may be helpful in these situations.

Official Title
-----------------
The Role of Muscular Ultrasound in Predicting Weaning Success

Conditions
-----------------
Respiratory Insufficiency

Intervention / Treatment
-----------------
* Other: Muscular ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients undergoing weaning from mechanical ventilation Patients who have been mechanically ventilated for more than 72 hrs Exclusion Criteria: Pregnant patients Patients with previous neuromuscular diseases Difficulties in muscular ultrasound (Dressing, operation, etc)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Muscular ultrasound<br> | Other: Muscular ultrasound<br>* Muscular ultrasound is done before extubation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extubation success (no need for reintubation) |  | 48 hours after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weaning success (no need for applying the ventilator again) |  | 2 hours after spontaneous breathing trial | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasonography, Weaning
Characteristics Predictive of Pessary Success

Study Overview
=================
Brief Summary
-----------------
Pessaries are mechanical support devices worn vaginally to treat the symptoms of pelvic organ prolapse, such as vaginal pressure or a vaginal bulge. Pessaries are one of the options along with surgery and expectant management for pelvic organ prolapse. As the aging population grows, more patients will need treatment for pelvic organ prolapse. Various studies have been conducted previously to identify patient parameters predictive of successful pessary fitting and continued use. Our study is a retrospective chart review to identify patient characteristics predictive of successful pessary fitting and use, specifically focusing on the parameters of POPQ, pelvic organ prolapse quantification exam, and the ratio of the genital hiatus, which is the length of the vaginal opening, and total vaginal length.

Official Title
-----------------
Characteristics Predictive of Pessary Success

Conditions
-----------------
All Patients Who Have Undergone a Pessary Fitting

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergone a pessary fitting by physicians in the division of Urogynecology between the years of 2000 to 20008. Exclusion Criteria: Patients will be excluded only if their chart does not contain the clinical data under review.
Sexes Eligible for Study
-----------------
Female

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pelvic organ prolapse, pessary fitting
Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106)

Study Overview
=================
Brief Summary
-----------------
This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a non-U.S. marketed formulation of ondansetron.

Official Title
-----------------
An Open-Label, Randomized, Single-Dose, 2-Period Crossover Study to Determine the Bioequivalence of 2 Formulations of Ondansetron in Healthy Young Adult Male and Female Subjects

Conditions
-----------------
Chemotherapy-Induced Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: ondansetron clinical trial formulation
* Drug: ondansetron marketed formulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: If female, subject is not pregnant or breast-feeding Subject has been a nonsmoker for at least 6 months Subject is in good health Exclusion Criteria: Subject has a history of high blood pressure, asthma, other pulmonary disease, Gastrointestinal (GI) abnormalities/peptic ulcers, or cardiovascular, liver, neurologic, or kidney disease Subject is a habitual and heavy consumer of caffeine

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>clinical trial formulation | Drug: ondansetron clinical trial formulation<br>* Single dose of an over-encapsulated 8 mg tablet of United Kingdom (U.K.) ondansetron (ZOFRAN™) in one of two treatment periods.<br>* Other names: ZOFRAN™;|
| Active Comparator: B<br>non-U.S. marketed formulation | Drug: ondansetron marketed formulation<br>* Single dose of an 8 mg tablet of U.K. ondansetron (ZOFRAN™) in one of two treatment periods.<br>* Other names: ZOFRAN™;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron |  | 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours postdose | 
| Peak Plasma Concentration (Cmax) for Ondansetron |  | 24 hours post-dose |
Genetic Expression and Prediction of Response to Neoadjuvant Docetaxel or Doxorubicin in Locally Advanced Breast Cancer

Study Overview
=================
Brief Summary
-----------------
After a core biopsy of the tumor is obtained, patients with locally advanced breast cancer are randomized to receive 4 cycles of full dose doxorubicin (75 mg/m2 e3w) or docetaxel (100 mg/m2 e3w). After the fourth cycle, patients are submitted to surgery to ascertain pathological response. They then receive the opposite drug, hormones, Herceptin, and radiation as indicated.

Detailed Description
-----------------
The aim of the study is to define the genetic signature which predicts the response to single drug doxorubicin versus docetaxel. 250 patients will be included. cDNA microarrays will be produced and the genetic pattern will be correlated with the response to doxorubicin and docetaxel. Secondary aim is the prediction of response by means of IHC determinations (her2, ER, PgR, Ki67, protein TAU), FISH (topoisomerase II alpha, her2) and PCR (topoisomerase II alpha).

Official Title
-----------------
Patterns of Genetic Expression Associated to Sensibility to Doxorubicin Versus Docetaxel as Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer

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

Intervention / Treatment
-----------------
* Drug: docetaxel
* Drug: doxorubicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Locally advanced, inoperable breast carcinoma or stage II not amenable to breast preserving surgery (amendment introduced on november 2006) Signed informed consent Exclusion Criteria: Age >75 Cardiac disease; LEFT <50% Hyperbilirubinemia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>doxorubicin | Drug: doxorubicin<br>* 75 mg/m2 every 3 weeks times 4<br>* Other names: adriamycin;|
| Other: 2<br>docetaxel | Drug: docetaxel<br>* 100 mg/m2 every 3 weeks times 4<br>* Other names: taxotere;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation of genetic tumoral pattern with response to docetaxel versus doxorubicin |  | 2005-2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate to doxorubicin versus docetaxel |  | 2005-2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, neoadjuvant chemotherapy, genetic signature, doxorubicin, docetaxel
Preemptive Lung Impedance-Guided Therapy in Evolving Acute Heart Failure in Acute Myocardial Infarction Patients

Study Overview
=================
Brief Summary
-----------------
It is well-known that 20-25% of patients hospitalized for acute myocardial infarction will develop acute heart failure during their hospitalization. Currently, the investigators have no reliable parameter for prediction of evolving acute heart failure in such a group of patients. As a result, the investigators have no way of preventing acute heart failure. Treatment of these patients only begins after appearance of clinical signs of acute heart failure. Lung impedance monitoring may be a good non-invasive parameter for prediction of evolving acute heart failure. This study will attempt to address whether preemptive lung impedance-guided therapy may prevent the development of overt acute heart failure and improve their clinical outcome.

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: Usual treatment of patients with developing acute heart failure
* Device: Lung Impedance-Guided Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients hospitalized in the ICCU for acute myocardial infarction and developing acute heart failure Exclusion Criteria: Patients with acute myocardial infarction with clinical and radiological signs of acute heart failure at admission

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
Interventional Model Description: In this study the interventional group was treated preemptively according to the lung-impedance protocol and the control group was treated only according to clinical assessment.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Treatment Heart Failure<br>Conventional Treatment | Other: Usual treatment of patients with developing acute heart failure<br> <br> |
| Experimental: Lung Impedance-Guided Therapy<br>Lung Impedance-Guided Therapy | Device: Lung Impedance-Guided Therapy<br>* Non-invasive lung impedance monitor (RSMM Company, Tel Aviv, Israel)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of acute heart failure development in acute MI patients |  | Three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of clinical outcome in patients with lung impedance-guided treatments |  | Three years |
Relationship of Metabolic Syndrome and Its Components With Thyroid Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the association between metabolic syndrome (MS), body mass index (BMI), hyperglycemia, dyslipidemia, hypertension and thyroid cancer. Screen for the risk factors that affect the incidence of thyroid cancer.

Official Title
-----------------
Relationship of Metabolic Syndrome and Its Components With Thyroid Cancer

Conditions
-----------------
Thyroid Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergone thyroid surgery signed the informed consent Exclusion Criteria: 1.patients with no surgery

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The thyroid cancer group<br>The postoperative pathology of thyroid is malignant | |
| The thyroid nodule group<br>The postoperative pathology of thyroid is benign | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipids |  | before the thyroid surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose |  | before the thyroid surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolic Syndrome, fasting plasma glucose
Pain Associated With Endometriosis

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy and safety of an investigational medication compared with placebo in the treatment of pain associated with endometriosis.

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Drug: Danazol Once Weekly
* Drug: Danazol Twice Weekly
* Drug: Placebo Once Weekly
* Drug: Placebo Twice Weekly


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Menstruating female 18-50 years of age, Regular cycle length of 21 to 35 days with menstrual bleeding that typically lasts no more than 7 days, Has pain associated with endometriosis, Has a documented history consistent with endometriosis, Exclusion Criteria: Is pregnant or lactating, Has a history of or has active thrombosis

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Danazol Once Weekly<br>* semi-solid<br>|
| Experimental: 2<br> | Drug: Danazol Twice Weekly<br>* semi-solid<br>|
| Placebo Comparator: 3<br> | Drug: Placebo Once Weekly<br>* semi-solid<br>|
| Placebo Comparator: 4<br> | Drug: Placebo Twice Weekly<br>* semi-solid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain associated with endometriosis |  | 3 months of treatment |