linjc16/ctgov huggingface dataset:
Toxicities of Cervix and Corpus Uteri Carcinomas Treatment and Evaluation of Impact on Sexual Function

Study Overview
=================
Brief Summary
-----------------
Evaluate the toxicities of cervix and corpus uteri carcinomas treatment

Detailed Description
-----------------
Evaluate the toxicities of cervix and corpus uteri carcinomas treatment on sexual function after treatment (radiotherapy and/or surgery)

Official Title
-----------------
Prospective Observational Study of Toxicities of Cervix and Corpus Uteri Carcinomas Treatment and Evaluation of Impact on Sexual Function

Conditions
-----------------
Corpus Uteri Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients whose treatment is provided to Centre Oscar Lambret With a corpus uteri adenocarcinoma, no metastatic, treated by: Surgery and observation without complementary treatment Or surgery and adjuvant radiotherapy Or Surgery and curietherapy of vaginal dome With a cervix carcinoma, stade IA2 to IIB proximal, treated by : External radiochemotherapy and curietherapy Or only surgery Or pre-surgical curietherapy and surgery Age > 18 years

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Col 1<br>Patient with uterus adenocarcinoma, treated by surgery, then surveillance without complementary treatment | |
| Col 2<br>Patient with uterus adenocarcinoma, treated by surgery then adjuvant radiotherapy | |
| Col 3<br>patient with uterus adenocarcinoma, treated by surgery then curietherapy of vaginal dome | |
| Endometrial 4<br>patient with cervix carcinoma stage IA2 to IIB, treated by surgery only | |
| endometrial 5<br>patient with cervix carcinoma stage IA2 to IIB, treated by surgery then curietherapy | |
| endometrial 6<br>patient with cervix carcinoma stage IA2 to IIB, treated by surgery then curietherapy and radiotherapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicities including on sexual function | According to Lent-Soma, NCICTC-AE v3.0, Franco-Italian Glossary | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the various scales of toxicity | Compare the various scales of toxicity | up to 3 years | 
| Study the sexual behavior modifications | According to a questionnaire and a personal discussion | up to 3 years | 
| Specify correlation modifications of sexual behavior | Specify the existence of a correlation between toxicities included modifications and sexual behavior modifications | up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carcinoma, uterus, Not metastatic
Inferior Vena cavaCollapsibility Index in Patients With Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
This is an observational study that will examine the possibility of determining the type of Acute Kidney Injury (AKI) using bedside ultrasound machines.

Detailed Description
-----------------
The investigators hypothesize that different types of AKI (pre-renal, renal, and post-renal) are associated with different inferior vena cava diameters and collapsibility index. The investigators will include subjects ages 18-89 years with AKI (creatinine of 2mg/100ml or higher for less than 24 hours from baseline creatinine ≤1.2 or with unknown baseline creatinine). Standard of care treatment will not be different for patients taking part in this study. Participants will have bedside ultrasounds on days 0, 1, and 3, and baseline and follow-up data will be collected from medical records.

Official Title
-----------------
Inferior Vena Cava Collapsibility Index in Patients With Acute Kidney Injury

Conditions
-----------------
Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Creatinine of 1.7 mg/100ml or higher for less than 24 hours from baseline creatinine ≤1.2 or with unknown baseline creatinine Age range: 18-89 years Age range ≥ 18 Exclusion Criteria: 1. Only chronic renal disease will exclude a patient from our study regardless of past medical history and medications they are taking. (For the purposes of this study, any patient with creatinine higher than 1.2 mg /100ml for more than 24 hours will be identified as having chronic renal disease.)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- | --- |
| Maximum and Minimum Diameters of the Inferior Vena Cava in Patients With Acute Kidney Injury | The investigators will measure the maximum and minimum diameters of the inferior vena cava with patients with acute kidney injury. | Day 1 of ICU admission | 
| Percent Collapse of the Inferior Vena Cava in Patients With Acute Kidney Injury | The investigators will measure the maximum and minimum diameters of the inferior vena cava with patients with acute kidney injury and calculate the percent change between the maximum and minimum diameters. | Day 1 of ICU admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inferior vena cava, Kidney injury, Ultrasound
Prospective Research of Outcomes After Salpingo-oophorectomy

Study Overview
=================
Brief Summary
-----------------
PROSper is a prospective cohort study of 100 women 35-50 years of age with BRCA 1/2 mutations who have elected to either undergo risk reducing salpingo-oophorectomy (RRSO) or nonsurgical management. The investigators will compare the change in cardiovascular health, bone health, sexual function, quality of life, and menopausal symptoms over 3 years of follow-up between women who undergo RRSO (baseline just prior to surgery) and age-matched controls that do not undergo RRSO. The investigators hypothesis is that women who undergo a premature surgical menopause induced by RRSO have worse cardiovascular health and bone health compared with women who do not undergo RRSO.

Official Title
-----------------
Prospective Research of Outcomes After Salpingo-oophorectomy

Conditions
-----------------
BRCA1 Gene Mutation, BRCA2 Gene Mutation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BRCA mutation 1/2 or Variant suspected deleterious mutation. Female Age 35-50 years Able to undergo RRSO Speaks English Able to give informed consent Exclusion Criteria: Prior history of bilateral oophorectomy BRCA 1/2 deleterious mutation Plans to move out of geographic region in next 3 years Unable to travel to study visits

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treated with RRSO<br>Women with the BRCA gene 1/2 mutation who choose to undergo risk reducing salpingo-oophorectomy (RRSO) treatment. | |
| No RRSO treatment<br>Women with the BRCA gene 1/2 mutation who choose non-surgical treatment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in risk of cardiovascular disease and osteoporosis at 36 months. | We will use dual-energy x-ray absorptiometry (DEXA) scan results and Intima-media thickness of the carotid artery (IMT) testing to assess changes in bone mineral density and carotid artery intima media thickness, respectively. | Baseline to 36 Months | 
| Change in baseline sexual functioning and quality of life at 36 months. | We will use standard questionnaires to assess changes in overall quality of life and sexual function. | Baseline to 36 Months |
Blood Test to Predict Radiation Response and Toxicity in Patients Undergoing Radiation Therapy

Study Overview
=================
Brief Summary
-----------------
Collect blood samples and associated clinical data prior to and post radiation treatment.

Detailed Description
-----------------
Exploratory study to collect paired pre- and post-irradiation blood samples from 150 participants.

Official Title
-----------------
Blood Test to Predict Radiation Response and Toxicity in Patients Undergoing Radiation Therapy

Conditions
-----------------
Radiation Therapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients age 18 or older Diagnosed with a primary rectal or esophageal cancer Planned radiation therapy to the esophagogastric area to a minimum of 4140 cGy for esophageal/gastroesophageal junction cancer or to pelvis to a minimum of 4500 cGy for rectal cancer as part of clinical care Combining chemotherapy is allowed ECOG Performance Status 0-2 Able to provide written informed consent Exclusion Criteria: Subjects who have received radiation within three (3) months to esophagogastric or pelvic areas prior to consent Subjects, who in the opinion of the investigator, may not be able to comply with the requirements of 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of blood samples from patients prior to and post irradiation treatment. | Explore and validate a radiation sensitivity test for determining radiation treatment tumor response by refining and analyzing gene expression signature of blood samples collected from 150 patients prior to and post irradiation treatment. | Up to 4 months, from informed consent through follow up activities. |
Dynamic Changes of Circulating Tumor DNA in Surgical Lung Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Previous study showed circulating tumor DNA levels reflect the total systemic tumor burden. Circulating tumor DNA levels should decrease after complete surgery and could be increase as tumor recurrence. Few study investigated the half time of circulating tumor DNA in lung cancer patients that no criterion has been established of how to use it for surveillance.

Detailed Description
-----------------
For lung cancer patients who received surgery, multiple time of plasma will be collected before or after surgery. A series of mutations will be detected in plasma before surgery based on next generation sequencing. The positive mutation will be traced after surgery and in follow up.

Official Title
-----------------
Dynamic Changes and Surveillance of Circulating Tumor DNA in Surgical Non-small Cell Lung Cancer Patients

Conditions
-----------------
Carcinoma, Non-small-cell Lung Cancer, Lung Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected lung cancer before surgery No malignant tumor history within the past 5 years The pulmonary nodule is not pure ground glass opacity Patients must have given written informed consent Exclusion Criteria: Multiple primary lung cancer R1,R2 resection Histology confirmed not non-small cell lung cancer Unqualified blood samples

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Half-life of circulating tumor DNA after surgery |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The variation of circulating tumor DNA level before and after surgery |  | 3 months | 
| Correlation of circulating tumor DNA level after surgery with tumor recurrence |  | 3 years | 
| Correlation of circulating tumor DNA level after surgery with clinical features |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Circulating Tumor DNA, Half time, Lung cancer, Surgery, Surveillance
Methemoglobinemia After Liposuction - Diagnostic by Pulse Oximetry and Blood Gas Analysis.

Study Overview
=================
Brief Summary
-----------------
Tumescent local anesthesia is a procedure which is frequently performed for plastic cosmetic surgical procedures such as liposuction. The subcutaneous adipose tissue is infiltrated with large volumes of a solution which also contain local anesthetics. However local anesthetics, can also lead to a marked production of methemoglobin. New generation pulse oximeters are able to measure SpMetHb non-invasivly. The aim of this study is: to investigate multi-wavelength pulse oximetry as a monitoring method for patients at increased risk for methemoglobinemia. to illustrate MetHb concentrations over a course of 24 hours after a liposuction employing tumescent anesthesia has been carried out.

Official Title
-----------------
Methemoglobinemia After Liposuction Under Tumescent Local Anesthesia - Timecourse and Diagnostics by Pulse Oximetry and Blood Gas Analysis.

Conditions
-----------------
Methemoglobinemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: planned liposuction in tumescent local anesthesia Exclusion Criteria: hematologic disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SpMetHb > 8%<br>hemoximetric MetHb measurements triggered | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between hemoximetric and pulseoximetric measured methemoglobin |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time course of MetHb concentration following liposuction employing tumescent anesthesia. |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulse oximetry, tumescent anesthesia
Safety Follow-up Study of Inhaled Iloprost in Patients With Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to monitor long-term safety and tolerability of iloprost aerosol inhalation therapy in patients suffering from pulmonary hypertension.

Detailed Description
-----------------
This study has previously been posted by Schering AG, Germany. Schering AG has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Official Title
-----------------
Open-label, Uncontrolled, Long-term Surveillance Study of Iloprost Aerosol Inhalation Therapy in the Treatment of Patients With Primary or Secondary Pulmonary Hypertension. Follow-up Program for Patients Who Completed 12 Weeks in Study ME97218/300180.

Conditions
-----------------
Hypertension, Pulmonary

Intervention / Treatment
-----------------
* Drug: Ventavis (Iloprost, BAYQ6256)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of the 12-week treatment period of the predecessor Schering study 97218/300180 Investigator judged iloprost aerosol therapy warranted as a suitable treatment for the respective patient Negative pregnancy test for females Exclusion Criteria: Any condition during 12-week treatment period of the predecessor Schering study 97218/300180 that prevents participation in the follow-up safety surveillance study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 71 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Ventavis (Iloprost, BAYQ6256)<br>* Inhaled iloprost<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | Throughout the whole study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of treatment |  | Over a minimum of 24 months |
Immune Regulation in Multiple Sclerosis: MicroRNA and Antigen-Presenting Cells

Study Overview
=================
Brief Summary
-----------------
MicroRNAs regulate gene expression. The abnormal expression of microRNAs has been reported in many human diseases. The purpose of this pilot study is to determine if microRNA expression is changed in untreated and interferon-beta-treated patients with multiple sclerosis.

Detailed Description
-----------------
MicroRNAs regulate gene expression. The abnormal expression of microRNAs has been reported in many human diseases. The purpose of this pilot study is to determine if microRNA expression is changed in untreated and interferon-beta-treated patients with multiple sclerosis. The expression of microRNA will be analysed in cell subsets separated from peripheral blood mononuclear cells.

Official Title
-----------------
Immune Regulation in Multiple Sclerosis: MicroRNA and Antigen-Presenting Cells

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-60 year-old healthy subjects or patients with RRMS/CIS Exclusion Criteria: Any treatment with steroids in the last 30 days prior to the blood draw or any immunosuppressive or Disease-modifying treatment (DMT) other than Glatiramer Acetate in the last 90 days Presence of other disorders that may be associated with immune-deficient or autoimmune process (e.g., HIV, lymphoma, lupus) or demyelinating disease other than MS (e.g., Lyme, B12 deficiency) Pregnancy Intermittent or unilateral constant assistance (cane, crutch, brace) required to walk about 100 meters with or without resting (Expanded Disability Status Scale (EDSS) score greater than 5.5 )

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Healthy subjects<br>Self-explanatory | |
| Untreated patients<br>Patients diagnosed with relapsing-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS) who are not on any disease-modifying treatment approved for MS | |
| Treated Patients<br>Patients diagnosed with relapsing-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS) who were prescribed Interferon-beta-1a prior to enrollment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative MicroRNA expression in B cells | Expression of multiple microRNA is being tested in B cells in three groups of subjects at one time point | one time (baseline) |
Identification and Treatment of the Liability to Develop Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This study seeks to determine whether adult, non-psychotic, first-degree relatives of schizophrenic patients who show specific neurocognitive deficits and negative symptoms will show improvements in these areas following a 6-month, double-blind trial of a low dose (up to 2.0 mg) of risperidone.

Official Title
-----------------
Identification and Treatment of the Liability to Develop Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Risperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having at least one first-degree biological relative with schizophrenia and their age is between 19 and 59. Desire to participate in a medication trial. Is able to provide informed consent. Having moderate levels of negative symptoms, defined as 6 items rated 3 or higher on the Scale for the Assessment of Negative Symptoms (SANS). Scoring two or more standard deviations below normal in at least one of three cognitive domains: vigilance/working memory, long-term verbal memory, and executive functions. Scoring at least one standard deviation below normal in a second cognitive domain. Exclusion Criteria: IQ less than 80. Formal education less than 10 years. History of psychotic disorders. History of treatment with an antipsychotic medication. A substance abuse diagnosis within 6 months of diagnosis. A head injury with documented loss of consciousness exceeding 5 minutes (or subsequent cognitive deficits). A history of neurologic disease or damage. A medical condition with significant cognitive sequelae. A history of electroconvulsive treatment.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 59 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Risperidone|Risperidone will be given in low dosage to a random sample of family members of Schizophrenic patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological - cognitive measures |  | 2003-2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychiatric Symptoms |  | 2003-2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Negative symptoms, neuropsychological deficits, Cognitive function, diagnostic, prevention