linjc16/ctgov huggingface dataset:
Iron Balance Study of DFO and GT56-252 in Patients With Transfusional Iron Overload Secondary to Beta-Thalassemia

Study Overview
=================
Brief Summary
-----------------
A clinical trial designed to compare the safety and iron excretion properties of desferoxamine (DFO) and deferitrin (GT56-252), an experimental oral iron chelator.

Official Title
-----------------
Iron Balance Study of DFO and GT56-252 in Patients With Transfusional Iron Overload Secondary to Beta-Thalassemia

Conditions
-----------------
Beta-Thalassemia

Intervention / Treatment
-----------------
* Drug: Deferitrin (GT56-252)
* Drug: desferoxamine (DFO)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Beta-thalassemia patients, 18 years of age or older, currently undergoing chronic blood transfusion therapy and iron chelation therapy who weigh more than 40 kg. No clinically significant findings on physical exam, medical history, or screening laboratories. Serum ferritin greater than 500 ng/mL, serum creatine creatinine within the normal range and platelet count greater than 100,000/mm3. Willing and able to discontinue DFO or L1 for the period of study. Woman of child-bearing potential must have a negative serum pregnancy test at screening and use a medically acceptable form of birth control during the study and for 1 month afterward. Male patients must also use barrier contraceptives during the study and for 1 month afterward. Have a level of understanding and willingness to cooperate with the confinement and all procedures. Able to provide voluntary signed/dated written informed consent. Exclusion Criteria: Serious medical condition unrelated to Beta-Thalassemia. Participation in a previous investigational drug study within 30 days preceding screening. Patients with a known allergy to DFO that prevents chronic administration.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Deferitrin (GT56-252)|nan|
|Drug: desferoxamine (DFO)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability |  |  | 
| iron excretion in urine and stool |  |  | 
| pharmacokinetic measurements |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Beta Thalassemia
Symptom Evaluation After Cessation of a Proton Pump Inhibitor in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether proton pump inhibitor (PPI) induced hypersecretion leads to acid related symptoms after treatment in healthy volunteers.

Detailed Description
-----------------
Treatment with proton pump inhibitors (PPI) has been shown to cause rebound hypersecretion of gastric acid. The clinical significance of this phenomenon is however unclear. This study aims to examine whether or not healthy volunteers, who over a relatively short period of time treated with a PPI, develop dyspeptic symptoms after cessation of therapy. Dyspeptic symptoms will be measured subjectively using a validated questionnaire, which is filled out each day. Gastric acid will be measured indirectly with measurement of acid secretion markers (Gastrin and chromogranin-A).

Official Title
-----------------
Symptom Evaluation After Cessation of a Proton Pump Inhibitor in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: Pantoprazole
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers 18-70 years of age Informed consent No prior history of any GI disorder Exclusion Criteria: Dyspeptic complaints H. pylori infection Ongoing treatment with pain-relieving medications (i.e., NSAID) Pregnancy or breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Active Comparator: Pantoprazole<br> | Drug: Pantoprazole<br>* 40 mg pantoprazole once daily for 28 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* identical placebo once daily for 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate whether healthy volunteers, treated with PPI for four weeks, develop acid-related symptoms after cessation of PPI therapy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate whether there is a correlation between markers for acid secretion such as gastrin and chromogranin-A and the development of dyspeptic symptoms. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
volunteers
Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b (PEG-IFN) and Ribavirin (RBV) in treatment-naïve patients with (Genotype 1) hepatitis C.

Official Title
-----------------
A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin, in Treatment-Naïve Subjects With Genotype 1 Hepatitis C

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: MP-424
* Drug: Ribavirin
* Drug: Peginterferon Alfa-2b
* Drug: Ribavirin
* Drug: Peginterferon Alfa-2b


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Genotype 1, chronic hepatitis C Treatment-naïve (patient who has received no previous interferon based treatment for hepatitis C) Able and willing to follow contraception requirements Exclusion Criteria: Cirrhosis of the liver or hepatic failure Hepatitis B surface antigen-positive or HIV antibodies-positive History of, or concurrent hepatocellular carcinoma History of, or concurrent depression, schizophrenia; or suicide attempt in the past Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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: TRV/PEG/RBV<br> | Drug: MP-424<br>* 750 mg every 8 hours for 12 weeks<br>* Other names: Telaprevir;Drug: Ribavirin<br>* 600 - 1000 mg/day based on body weight for 24 weeks<br>Drug: Peginterferon Alfa-2b<br>* 1.5 mcg/kg/week for 24 weeks<br>Drug: Ribavirin<br>* 600 - 1000 mg/day based on body weight for 48 weeks<br>Drug: Peginterferon Alfa-2b<br>* 1.5 mcg/kg/week for 48 weeks<br>|
| Active Comparator: PEG/RBV<br> | Drug: Ribavirin<br>* 600 - 1000 mg/day based on body weight for 24 weeks<br>Drug: Peginterferon Alfa-2b<br>* 1.5 mcg/kg/week for 24 weeks<br>Drug: Ribavirin<br>* 600 - 1000 mg/day based on body weight for 48 weeks<br>Drug: Peginterferon Alfa-2b<br>* 1.5 mcg/kg/week for 48 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response) |  | After 24 weeks of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Hepatitis C, Protease Inhibitor, Telaprevir, Peginterferon Alfa-2b, Ribavirin
Nutritional Status Among Older Adults. Risk Factors and Consequences of Malnutrition

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to estimate the prevalence of malnutrition among older adults admitted to hospital and to analyse predictive factors for malnutrition. Further, the aim was to analyse the association between nutritional status and all-cause and cause-specific mortality. The hypothesis is that malnourished patients have a higher mortality then well-nourished patients after three years.

Detailed Description
-----------------
The baseline survey was a cross-sectional study of 1771 patients aged ≥65 years who were admitted to hospital. Nutritional status was assessed using the MNA instrument, and possible risk factors associated with malnutrition were recorded during the hospital stay. All-cause mortality was followed up after median 3.5 years s in a cohort study of 1767 participants. Cause-specific mortality was followed up after median 4.7 years in a cohort of 1767 participants. Previous dietary intake in middle-aged and older adults was recorded at basline in 725 participants, who had their nutritional status assessed with the MNA when admitted to hospital 10 years later.

Official Title
-----------------
Nutritional Status Among Older Adults. Risk Factors and Consequences of Malnutrition

Conditions
-----------------
Malnutrition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 65 years or older Exclusion Criteria: unable to communicate and no relative could anwer the questions (n = 356) receiving palliative care (n = 44) impossible to measure height or weight (n = 22) miscellanious (n = 71)

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status according to the screening instrument Mini Nutritional Assessment (MNA) | [The 18 questions in the MNA instrument are weighted, and the threshold values of the instrument categorize patients into three nutritional status groups: well-nourished (MNA score 24-30), at risk of malnutrition (MNA score 17-23.5), or malnourished (MNA score <17). | 30 minutes | 
| All-cause mortality | Survival was calculated from the date of the MNA screening to the date of death. | All-cause mortality was analyzed after median 3.5 years. | 
| Cause-specific mortality | Survival was calculated from the date of the MNA screening to the date of cause-specific death. | Cause-specific mortality was analyzed after median 4.7 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malnutrition, Aged, Aged 80 and over, Prevalence, Mortality
New Indications for Ultrasound in the Staging of Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose is to investigate and evaluate two new diagnostic methods using ultrasound in the staging of cervical cancer. 3-D-ultrasound of the tumour to estimate its volume and local spread Fusion of PET/CT and ultrasound to evaluate and biopsy lymph nodes.

Official Title
-----------------
New Indications for Ultrasound in the Staging of Cervical Cancer

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Procedure: biopsy
* Device: 3d-ultrasound and fusion of UL and PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cervical cancer, PET/CT pos. lymph nodes, Patients over 18 years old Exclusion Criteria: Pregnancy, Lactating, Diabetic

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: biopsy|nan|
|Device: 3d-ultrasound and fusion of UL and PET/CT|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Impact of a Topical Vasodilating Cream on Female Sexual Experience

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a topical vasodilating cream will improve female sexual experience.

Detailed Description
-----------------
To determine in a placebo controlled double blinded study whether a topically applied vasodilating cream will improve the female sexual response as measured by a standard female sexual dysfunction questionnaire

Official Title
-----------------
The Impact of a Topical Vasodilating Cream (When Applied to the Clitoris) on the Female Sexual Experience Using a Standard 7 Part Female Sexual Dysfunction Questionnaire

Conditions
-----------------
Female Sexual Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy females ages 25 to sixty sexually active Exclusion Criteria: Neurologic disease, on SSRI's,advanced diabetes, non sexually active, mentally incompetent

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 Years

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

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
-----------------
healthy females ages twentyfive through sixty
Buprenorphine/Naloxone for Treatment of Opiate Dependence - 9

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate-dependence treatment.

Official Title
-----------------
Trial of Buprenorphine/Naloxone for Treatment of Opiate Dependence

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine/naloxone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M/F ages 21-50. Meet DSM-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Buprenorphine/naloxone|nan|

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
-----------------
opioid dependence
FLowTriever for Acute Massive Pulmonary Embolism (FLAME)

Study Overview
=================
Brief Summary
-----------------
To evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism

Official Title
-----------------
FLowTriever for Acute Massive Pulmonary Embolism (FLAME)

Conditions
-----------------
PE - Pulmonary Embolism, PE - Pulmonary Thromboembolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >=18 years Treatment team determines pulmonary embolism is the cause of shock, and the PE is high-risk per the protocol definitions Exclusion Criteria: Out of hospital cardiac arrest with Glasgow Coma Scale of ≤8 Witnessed cardiac arrest with ongoing CPR >30 minutes Contraindication to anticoagulants, i.e. heparin or alternative Hematocrit <28% Platelets <25,000/μL INR >8 Intracardiac thrombus and/or intracardiac clot in transit Known anaphylactic sensitivity to radiographic agents that cannot be pre-treated History of pulmonary hypertension with systolic pulmonary arterial pressure >70 mmHg Presence of chronic medical conditions with estimated < 90 days life expectancy per physician discretion (should not consider the current pulmonary embolism and its treatment) Current participation in another drug or device treatment study that, in the Investigator's opinion, would interfere with participation in this study Patient is known to be COVID-19 positive at hospital admission (patient has active COVID-19)

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 |
| --- | --- |
| FlowTriever Arm<br>FlowTriever Arm subjects are defined as those subjects where FlowTriever is used as the Primary Treatment for pulmonary embolism. | |
| Context Arm<br>Subjects with high-risk pulmonary embolism who are treated with non-FlowTriever therapies. | |
| Prior Therapy Arm<br>Subjects presenting with low/intermediate-risk PE who received advanced therapy but subsequently progressed to high-risk PE in the same hospital setting/admission. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite incidence of all-cause mortality, clinical deterioration, bailout, and major bleeding | Endpoint events will be assessed from the time of treatment of the high-risk pulmonary embolism through hospital discharge for the high-risk PE, or through 45 days post treatment for high-risk pulmonary embolism, whichever comes first.. | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, which ever comes first. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PE, pulmonary embolism, thromboembolism, thrombectomy, FlowTriever, massive pulmonary embolism, high risk pulmonary embolism
Valsalva Maneuver in Thyroidectomy

Study Overview
=================
Brief Summary
-----------------
Bleeding after total thyroidectomy remains a rare event that affects early postoperative morbidity, occurring in 0.3% up to 4.2% of cases. Intraoperative bleeding is an unpleasant complication, and it is often easily manageable though postoperative bleeding may represent a life-threatening condition for the patient. Between January 2019 to February 2022 , 250 consecutive patients were listed for thyroidectomy. The Investigators selected 178 patients and divided them in two groups based on the execution of the Valsalva Manoeuvre. The purpose of the investigator is to clarify whether the routine intraoperative execution of a Valsalva manoeuvre (VM) may affect the detection of bleeding that would otherwise remain occult and therefore may manifest in the postoperative period.

Official Title
-----------------
Clinical Usefulness of the Valsalva Maneuver to Improve Hemostasis During Thyroidectomy

Conditions
-----------------
The Role of Valsalva Manoeuvre, in Thyroidectomy to Reduce Postoperative Bleeding

Intervention / Treatment
-----------------
* Procedure: Valsalva maneuver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: thyroid diseases Exclusion Criteria: lymph node dissection minimally invasive approaches high anesthesiological risk

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GROUP A-NO Valsalva maneuver<br> | |
| GROUP B- Valsalva maneuver<br> | Procedure: Valsalva maneuver<br>* Valsalva maneuver: increase intrabdominal pressure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of cervical drainage after total thyroidectomy | Bleeding after thyroidectomy is evaluated based on the total volume of cervical drainage output (ml) | 24 hours | 
| Number of reinterventions | Reoperations to resolve post thyroidectomy bleeding, which can cause airway compression and choking signs and symptoms. | 24 hours |