linjc16/ctgov huggingface dataset:
A Biological Sample Collection Protocol of Women With and Without Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to collect plasma, serum, whole blood and tissue samples from women with breast cancer and plasma, serum, whole blood from healthy women, which will be made available to researchers for biomarker analysis.

Detailed Description
-----------------
OUTLINE: This is a multi-center study. The treatment plan for each breast cancer subject will be determined at the discretion of the treating physician and subject. This protocol does not prescribe any particular standard of care treatment. There will be no treatment for the healthy volunteers.

Official Title
-----------------
A Biological Sample Collection Protocol of Women With and Without Breast Cancer: Hoosier Oncology Group Study BRE06-120 for the Analytical Proteomics Team

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: FOR WOMEN WITH BREAST CANCER Histologically or cytologically confirmed invasive malignancy or ductal carcinoma in situ of the breast. Preparing to begin a new regimen for breast cancer (adjuvant, locally recurrent, any line metastatic). Female. Age > 18 years at the time of consent. Written informed consent and HIPAA authorization for release of personal health information. FOR HEALTHY VOLUNTEERS No known history of invasive malignancy or ductal carcinoma in situ. Volunteers must not have prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin. Other cancers with low potential for metastasis, such as in situ cancers (e.g., Grade 1, TA TCC (low grade superficial bladder cancer), colonic polyp with focus of adenocarcinoma) can also be enrolled as healthy volunteers. Female Age > 18 years at the time of consent. Written informed consent and HIPAA authorization for release of personal health information. Exclusion Criteria: Females must not be pregnant.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Healthy women | |
| 2<br>Women with breast cancer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Cancer Survival in Reunion Island , 1998-2008 (SUCRE)

Study Overview
=================
Brief Summary
-----------------
Cancer survival is important to determine prognostic of patients and evaluate care and prevention health strategies. Sucre is the first study to describe cancer survival in Reunion Island. Sucre aims at evaluating five year cancer prognostic in Reunion Island by cancer site and gender. Sucre is a retrospective cohort study of cancer diagnosed between 01/01/1998 and 31/12/2008.

Detailed Description
-----------------
Data are extracted from Reunion Island Cancer Registry.

Official Title
-----------------
Survie Des Personnes Atteintes de Cancer à la Réunion, 1998-2008 (SUCRE)

Conditions
-----------------
Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients domiciled in Reunion Island at diagnosis Patients with at least 15 years of age at diagnosis Patients with cancer diagnosis between 01/01/1998 and 31/12/2008 Exclusion Criteria: Cutaneous malignant cancer expected melanoma

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- | --- |
| 5 years related survival rate by cancer site and gender |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1, 3, 5 and 10 years related survival rate by cancer site and gender |  | 1, 3, 5 and 10 years | 
| 1, 3, 5 and 10 years standardised survival rate by cancer site and gender |  | 1, 3, 5 and 10 years | 
| 1, 3, 5 and 10 years related survival rate by age at diagnosis |  | 1, 3, 5 and 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Survival, Cancer
Luteal Phase Administration of Paroxetine for the Treatment of PMDD

Study Overview
=================
Brief Summary
-----------------
The efficacy of SSRI use to relieve the symptoms associated with premenstrual dysphoric disorder has been established. We proposed to test the hypothesis that intermittent treatment with paroxetine administered during the luteal phase of the menstrual cycle only is more effective than placebo in improving symptoms of PMDD. This was a double-blind, placebo-controlled, three-arm parallel group study of patients with PMDD. Menstruating women 18 years of age or older who met criteria for inclusion in the study were randomized to one of three arms: paroxetine 10mg/day during the luteal phase of the menstrual cycle; paroxetine 20mg/day during the luteal phase of the menstrual cycle; placebo daily during the luteal phase of the menstrual cycle. The objective was to evaluate the efficacy and safety of intermittent treatment of paroxetine in women with PMDD.

Official Title
-----------------
Luteal Phase Administration of Paroxetine for the Treatment of PMDD: A Randomized, Double-Blind, Placebo-Controlled Trial in Canadian Women

Conditions
-----------------
Premenstrual Dysphoric Disorder

Intervention / Treatment
-----------------
* Drug: Paroxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PMDD according to DSM-IV criteria Exclusion Criteria: Women were excluded if they were taking oral contraception, breast-feeding, pregnant, or planning to become pregnant during the study period. Women were also excluded if they met DSM-IV criteria for any Axis I disorder, were deemed a suicidal risk, had a history of SSRI use for premenstrual symptoms, were taking ongoing medication that could affect PMDD symptoms, had a clinically significant abnormality on screening blood tests, or had a baseline Montgomery-Asberg Depression Rating Scale score of equal to or greater than 10 during the follicular phase of the menstrual cycle.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Placebo Comparator: Paroxetine 10mg;paroxetine 20mg; Placebo<br> | Drug: Paroxetine<br>* Paroxetine 10mg and 20mg during the luteal phase of the menstrual cycle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scales |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PMTS-O; CGI-S; Sheehan Disability Scale |  |  |
New Mexico Honey Wound Treatment Research Study

Study Overview
=================
Brief Summary
-----------------
In a time of emerging bacteria that are resistant to antibiotics, honey offers an alternative that has potential to reduce the heavy reliance on pharmaceutical antibiotics. We will be evaluating the effectiveness of a locally produced New Mexico Honey against the standard of care Bactrim antibiotic on Community Acquired MRSA.

Detailed Description
-----------------
Locally grown New Mexico Honey will be utilized on abscess wounds of the trunk and extremities vs routine (Bactrim) antibiotic care to determine if NM Honey is effective treatment for Community Acquired MRSA 6 cm abscesses.

Official Title
-----------------
New Mexico Honey Wound Treatment Research Study

Conditions
-----------------
Community-acquired Methicillin-resistant Staphylococcus Aureus Infection

Intervention / Treatment
-----------------
* Drug: New Mexico Honey
* Drug: Bactrim DS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 16 years of age or older Abscess less than or equal to 6 cm in diameter on the extremity or trunk requiring incision and drainage Patient willing to try honey prepared dressing Patient able to return to office each day for 7 days for evaluation Exclusion Criteria: Under the age of 16 Abscess of face, scalp or genitals Diagnosed as a diabetic Allergic to bee pollen, honey or sulfa antibiotics Diagnosed with peripheral vascular disease Patient acknowledgement of current drug or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 75 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NM Regional Honey<br>15 ml of NM Honey applied directly to wound | Drug: New Mexico Honey<br>* Apply 15 ml of NM Honey to CA-MRSA Abscess compare to standard antibiotic treatment<br>* Other names: Local New Mexico Honey;Drug: Bactrim DS<br>* Bactrim DS<br>* Other names: sulfamethoxazle-trimethroprim DS;|
| Active Comparator: Bactrim DS<br>Standard of Care Oral Antibiotic | Drug: New Mexico Honey<br>* Apply 15 ml of NM Honey to CA-MRSA Abscess compare to standard antibiotic treatment<br>* Other names: Local New Mexico Honey;Drug: Bactrim DS<br>* Bactrim DS<br>* Other names: sulfamethoxazle-trimethroprim DS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of lesion at day 7 | Increase in size will determine failure; Decrease in size will determine success | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Community acquired MRSA, New Mexico Honey
Combivent® CFC Metered Dose Inhaler (MDI) in Moderate to Severe Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the superior bronchodilator efficacy of inhaled Combivent® CFC MDI vs. Albuterol HFA MDI in moderate to severe asthma patients.

Official Title
-----------------
A Single Dose, Randomized, Double-blind Crossover Comparison of Combivent CFC MDI and Albuterol HFA MDI in Patients With Moderate to Severe Persistent Asthma and Persistent Symptoms Despite Treatment With Inhaled Corticosteroids

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Combivent® CFC MDI
* Drug: Albuterol HFA MDI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient greater than or equal to 18 years of age, non-smokers, diagnosed with asthma, with an FEV1 less than or equal to 70 percent of predicted normal, stable use of Beta agonist daily use of inhaled steroids for one year Exclusion Criteria: Patients with other significant diseases other than asthma, requiring oxygen, intubated within 5 years, asthma exacerbation within 6 weeks of trial, use of unstable doses (greater than 10 mg/day of prednisone or equivalent) of steroids, participating in another interventional trial

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Combivent® CFC MDI|nan|
|Drug: Albuterol HFA MDI|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 area under the curve (AUC) 0 to 6 hours Peak FEV1 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 at each timepoint Peak FVC FVC at each timepoint FVC AUC 0-6 Adverse events Vital signs |  |  |
Prediction of Non-motor Symptoms in Fully Ambulatory MS Patients Using Vocal Biomarkers

Study Overview
=================
Brief Summary
-----------------
The investigator will set up a study evaluating vocal biomarkers in people with MS in order to identify persons with non-motor symptoms: depression, cognitive deterioration, and fatigue. Up to now, to the best of the investigator's knowledge, there is no study reporting the use of vocal biomarkers to predict these three non-motor symptoms in people with MS.

Official Title
-----------------
Prediction of Non-motor Symptoms in Fully Ambulatory MS Patients Using Vocal Biomarkers

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

Intervention / Treatment
-----------------
* Other: Voice analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsing MS Age over 18 EDSS < 4.0 Capability of written informed consent Exclusion Criteria: Not fluent in german language Relapse or Steroids per os/intra venous < 4 weeks prior to examination KM enhancing lesion in MRI < 4 weeks prior to examination Other previous disease affecting the speech Pregnant patients Mental disability and not able to understand the protocol and study tasks in german languagePatients with greater physical and cognitive disability or history of major depressive disorder and suicide attempt/suicidal thoughts Patients with sleep disorders and comorbidities associated with extreme fatigue (e.g., fibromyalgia)

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 |
| --- | --- |
| Patients with relapsing MS<br> | Other: Voice analysis<br>* Voice analysis<br>|
| Healthy controls<br> | Other: Voice analysis<br>* Voice analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of a voice signature that separates between pwMS with and without fatigue |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of a voice signature that separates between pwMS with and without cognitive impairment |  | One year | 
| Identification of a voice signature that separates between pwMS with and without depression |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Digital Biomarker, Non-Motor symptoms, Fatigue, Cognition, Depression, Voice Analysis
A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3)

Study Overview
=================
Brief Summary
-----------------
Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent history of artificial tear use.

Official Title
-----------------
A Phase 3, Multicenter, Randomized, Double-masked, and Placebo-controlled Study Evaluating the Efficacy and Safety of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease and History of Recent Artificial Tear Use

Conditions
-----------------
Dry Eye Disease

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient-reported history of Dry Eye Disease in both eyes. Use of over the counter artificial tears within the past 30 days. A negative urine pregnancy test for females and willingness to use adequate birth control throughout the study. Able and willing to comply with all study procedures. Exclusion Criteria: Presence of an ocular condition that could affect the study parameters such as active ocular infections, ocular inflammation, glaucoma, or diabetic retinopathy;. Unwilling to stop wearing contact lenses during the study. LASIK or other ocular surgical procedures within 12 months prior to or during the study. Use of prohibited medications Significant medical conditions that could affect the study parameters.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifitegrast<br>Lifitegrast Ophthalmic Solution 5%, BID for 84 days | Drug: Lifitegrast<br>* Lifitegrast Ophthalmic Solution 5%, BID for 84 days<br>|
| Placebo Comparator: Placebo<br>Placebo to match active treatment, BID for 84 days | Drug: Placebo<br>* Placebo to match active treatment, BID for 84 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Patient-Reported Eye Dryness Score to Day 84 | Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort). | Baseline to Day 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42 | Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort). | Baseline to Day 14 and Day 42 |
Uterine Artery Pulsatility Index and Materno Fetal Outcomes

Study Overview
=================
Brief Summary
-----------------
High Uterine artery index pulsatility (PI) is associated with small for gestationnal age but also with stillbirth and distress during labor.

Detailed Description
-----------------
measures of Uterine artery PI is made with transabdominal color flow during labor. The right and left uterine arteries are visualized at the crossover wth the external iliac arteries. PI is measured and the mean PI of the two vessels is calculated and expressed as multiple of the median (MoM).The outcomes stillbirth, distress and vaginal or cesarean delivery, apgar sore <7 at 5 minutes, birth weight and maternal outcomes: preeclampsia, hemorrhage and other complications are noted.

Official Title
-----------------
Uterine Artery Pulsatility Index During Labor After 34 Weeks in the Prediction of Materno Fetal Outcomes

Conditions
-----------------
Labor Complication

Intervention / Treatment
-----------------
* Radiation: normal PI
* Radiation: pathological PI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gestationnal age >=34 weeks during labor Exclusion Criteria: elective cesarean even if labor non elligible ultrasound criteria of good measurement of uterine artery PI
Sexes Eligible for Study
-----------------
Female

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: normal PI<br>Uterine artery PI expresserd in MoM is <95e percentile | Radiation: normal PI<br>* measurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM<br>|
| Active Comparator: pathological PI<br>Uterine artery PI expressed in Multiple of Mediane (MoM) is >=95e percentile | Radiation: pathological PI<br>* measurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| right uterine artery pulsatility index measurement |  | 15 minutes | 
| left uterine artery pulsatility index measurement |  | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal outcome | number of patients with hemorrhage, preeclampsie, adversal outcomes | 2 days | 
| small for gestationnal age (SGA) | number of neonatal SGA | 1 day | 
| Apgar Score<7 | number of birth with Apgar score <7 | 1 day | 
| distress | number of cesarean section for distress | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stillbirth, hemorrhage
Speech and Swallowing Characteristics of Patients After Laryngectomy and the Effect on Quality of Life

Study Overview
=================
Brief Summary
-----------------
Swallowing and speech difficulties will be observed in patients post laryngectomy. These difficulties will cause decreased in quality of life.

Detailed Description
-----------------
This study will explore the characteristics of speech and swallowing problems of patients who underwent laryngectomy.The relationship between swallowing disturbances and speech difficulties will be studied and the effect of each problem on quality of life will be messured.

Official Title
-----------------
Speech and Swallowing Characteristics of Patients After Laryngectomy and the Effect on Quality of Life

Conditions
-----------------
Cancer of the Larynx

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients post total laryngectomy with voice prothesis Exclusion Criteria: patients who can not read and respod to questions

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 80 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 |
| --- | --- |
| Total laryngectomy<br>A group of patients who underwent total laryngectomy with trechea esophageal puncture (TEP) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech and swallowing characteristics of patients post laryngectomy | After recording the patients' speech the speech characteristics will be analysed according to specific parameters. Also after performing swallowing eveluation swallowing disturbances will be diagnosed and described. | At the completion of data collection -1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship between speech and swallowing disturbances of patients post laryngectomy | After analyzing the speech and swallowing disturbances of patients post laryngectomy, the relationship between these variables will be examined. | 1 year at the completion of data collection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laryngectomy, swallowing disturbances, speech disturbances, speech intelligibility, voice prothesis