linjc16/ctgov huggingface dataset:
a Flexible Wound Dressing for the Management of Genital Skin Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to determine the efficacy of 7-0940 in the management of genital skin conditions in female patients

Official Title
-----------------
Post-marketing Surveillance of a Flexible Wound Dressing for the Management of Genital Skin Conditions

Conditions
-----------------
Vaginitis, Atrophic Vaginitis, Lichen Planus, Lichen Sclerosus, Menopause Related Conditions

Intervention / Treatment
-----------------
* Device: Film forming silicone gel (7-0940)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to provide informed consent Diagnosed genital skin condition Exclusion Criteria: Unable to give informed consent Patient unable to apply topical device Allergy or intolerance to ingredients or excipients of the formulation of studied products
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>Film forming silicone gel (7-0940) is an innovative gel that forms a full contact, flexible wound dressing for supporting mucosal conditions of the genital, rectal and perineal areas. Film forming silicone gel (7-0940) is a semi-occlusive, non-resorbable, self-drying and transparent gel. Film forming silicone gel (7-0940) may be directly applied to dry, wet, cracked and sensitive mucosal tissue. Film forming silicone gel (7-0940) gel is bacteriostatic and inert. It contains no alcohols, parabens or fragrances. | Device: Film forming silicone gel (7-0940)<br>* Anecdotal evidence suggests that genital conditions in women associated with vaginal atrophy improve with the use of film-forming silicone dressings.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gynaecological skin condition | Likert scales to measure: Dryness Tissue thinning Erosion/Ulcers Fissures Erythema Scarring/adhesion Contact bleeding Bloodblisters Greyish film White lacy streaks | Duration of the therapy will be according to physician's clinical practice. The average is 3 visits over a period of 3 to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient symptoms | Likert scales to measure: Pruritus/itchiness Tender/sore Swelling Dryness Burning of skin Dyspareunia Stinging with urination/clothes Defecating pain/burning | Duration of the therapy will be according to physician's clinical practice. The average is 3 visits over a period of 3 to 6 months |
Diphenoxylate / Atropine to Decrease FDG Activity During F-18 FDG PET

Study Overview
=================
Brief Summary
-----------------
2-[18F]-fluoro-2-deoxyD-glucose positron emission tomography (FDG PET) has proven to be a valuable clinical tool for the staging and surveillance of lymphoma.1-6 Occasionally, lymph nodes in the mesentery and retroperitoneum can be difficult to distinguish from normal bowel activity on PET scans despite three-plane and cine maximal image projection (MIP) imaging. This uncertainty limits the clinical usefulness of PET in some cases of lymphoma.7-8 In addition, bowel activity can also hinder interpretation of PET scans in other types of solid tumors including melanoma and colorectal cancer.6,9,10 Our goal is to determine how well diphenoxylate/atropine 5mg/0.05mg (Lomotil) decreases bowel activity and how this decrease impacts clinical decision-making, specifically for lymphoma staging and surveillance. This is a prospective, randomized, double-blinded study involving 60 patients undergoing PET scans for newly diagnosed or recurrent, untreated lymphoma.

Official Title
-----------------
Diphenoxylate / Atropine to Decrease Bowel Activity During F-18 FDG PET

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Drug: Lomotil
* Other: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Males and females 18 years of age or older Subjects pre-scheduled for clinically-indicated PET scan Subjects with newly diagnosed or recurrent untreated disease (lymphoma) based on abdominal and/or pelvic adenopathy or masses on CT within 6 months of PET scan Exclusion Criteria Allergy to Lomotil (Diphenoxylate hydrochloride, Atropine sulfate) Subjects with one or more episodes of diarrhea within 24 hours prior to PET scan Women who are breast-feeding Subjects with a history of severe liver disease, jaundice, dehydration, or narrow-angle glaucoma

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Lomotil given | Drug: Lomotil<br>* Orally 10ml of Lomotil<br>|
| Placebo Comparator: 2<br>Normal Saline given | Other: Normal saline<br>* 10 ml orally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of bowel activity |  | 1hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of stomach activity |  | 1 hour |
Clinical Study of Pregnant Women With COVID-19

Study Overview
=================
Brief Summary
-----------------
A new pandemic, COVID-19, has spread rapidly around the world. She does not spare pregnant women. Little is known about the clinical course of pregnant women infected with COVID-19. As of April 1, 2020, six case series and one case report for a total of 61 pregnancies affected by COVID-19, all from the pandemic epicenter in China, except for one state case report -Unis, have been published. These preliminary reports suggest that pregnant women are not more seriously affected than the general population and show a certain gap with what we have observed in the care of pregnant women at HUS. For these reasons, additional information, especially from parts of the world other than China, as the severity of the disease can vary from country to country, is urgently needed to determine whether pregnant women with the disease of COVID-19 will not present with severe pneumonia to COVID-19.

Official Title
-----------------
Clinical Study of Pregnant Women With COVID-19: A Retrospective Review of Medical Records at Strasbourg University Hospitals

Conditions
-----------------
Covid-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult woman (≥18 years old) Pregnant woman Suffering from a confirmed or suspected COVID-19 infection Patient who has been medically treated at Strasbourg University Hospitals as well as for his newborn baby, between 03/01/2020 and April 30, 2020 Woman having given, after information, her agreement for the reuse of her data for the purposes of this research Exclusion criteria: Patient who expressed her opposition to participating in the study Patient under guardianship or under guardianship Patient under legal protection

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A retrospective review of the medical records of pregnant women with COVID-19 at the University Hospitals of Strasbourg |  | Files analysed retrospectively from March 01, 2020 to April 30, 2020 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, COVID-19 Pandemic, Sars-cov-2, Pregnant women
Optimal Fluid Resuscitation for Trauma Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the overall fluid requirements for the first 24 hours after admission will be reduced with Hextend versus a standard of care crystalloid resuscitation fluid.

Detailed Description
-----------------
Following severe multi-system traumatic injury, the first 24 hours of standard resuscitation fluid will be either Hextend or crystalloid depending upon attending preference. No tests or interventions will be performed for research purposes. Data will be collected prospectively from patient medical records and attending clinicians to monitor fluid requirements, hemodynamics and outcome.

Official Title
-----------------
Optimal Fluid Resuscitation for Trauma Patients

Conditions
-----------------
Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than or equal to 18 years old and less than 65 years old Admission with multi-system traumatic injury Admission to the intensive care unit Exclusion Criteria: Less than 18 or greater than 65 years old Pregnant or lactating No fluid resuscitation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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 |
| --- | --- | --- |
| Mortality |  | From hospital arrival up to an average of 3.5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trauma Resuscitation
Connective Tissue Motion Measure 2

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the Connective Tissue Motion Measure (CTMM) in low back pain and no-low back pain subjects, evaluate the reliability of the CTMM, and examine the correlation of CTMM with low back pain symptoms, disability, and functional measures. The investigators hypothesize that CTMM will be reduced, on average, in low back pain subjects, that CTMM will be reliable with an intra-class correlation greater than 0.8, and CTMM will negatively correlate with low back pain symptoms, disability and functional measures.

Conditions
-----------------
Low Back Pain, Musculoskeletal Pain

Intervention / Treatment
-----------------
* Device: StromaGlide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for all subjects: able to stand and walk without assistance able to read and understand English able to understand and sign a consent form Inclusion Criteria for low back pain subjects: history of recurrent or chronic low back pain Inclusion criteria for no-low back pain subjects: no history of low back pain or other chronic pain that has limited activities of daily living or work numerical chronic pain index of less than 0.5 Exclusion Criteria for all subjects: previous severe back or lower extremity injury or surgery major structural spinal deformity (scoliosis, kyphosis, stenosis) ankylosing spondylitis or rheumatoid arthritis neurological deficit (weakness or sensory loss, decreased deep tendon reflexes suggesting nerve root compression, but not subjective symptoms of nerve root irritation (sciatica)) radicular pain neurological or major psychiatric disorder bleeding disorders corticosteroid or anticoagulant medication substance abuse pregnancy active worker's compensation or disability case in litigation for a low back pain problem acute systemic infection

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 |
| --- | --- |
| Low back pain subjects<br>Subjects with chronic or recurrent low back pain | Device: StromaGlide<br> <br> |
| No low back pain subjects<br>Subjects who are generally healthy with no low back pain | Device: StromaGlide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Connective Tissue Shear Strain Motion |  | Baseline | 
| Change in Connective Tissue Shear Strain Motion |  | Baseline to 1 hour | 
| Change in Connective Tissue Shear Strain Motion |  | Baseline to one day | 
| Change in Connective Tissue Shear Strain Motion |  | Baseline to one week |
Arimidex Bone Mass Index and Oral Bisphosphonates

Study Overview
=================
Brief Summary
-----------------
To investigate the management of bone health in postmenopausal women with early breast cancer (BCA) scheduled to receive anastrozole. Postmenopausal women with hormone receptor-positive early BCA are assigned to 1 of 3 strata depending on their pre-existing risk of fragility fracture. Patients (pts) with a bone mineral density (BMD) T-score <-2.0 for either spine or hip are designated higher-risk (H) for fracture and receive anastrozole 1 mg/day plus risedronate orally. Moderate-risk (M) pts (T-score <-1.0 for spine or hip but -2.0 at both sites) are randomized to receive anastrozole plus risedronate (A+R) or anastrozole alone. Pts with T-scores -1.0 at both spine and hip were designated lower-risk (L) and receive anastrozole alone. All pts receive calcium and vitamin D. Lumbar spine and total hip BMD are assessed at baseline, 12, and 24 months.

Official Title
-----------------
A Phase III-IV, Multicenter Open Label Trial of Arimidex Alone Versus Arimidex Plus Bisphosphonates in Postmenopausal Patients With Early, Endocrine Positive Breast Cancer.

Conditions
-----------------
Breast Cancer, Bone Density

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women ER and or PgR positive breast cancer Completed Surgery and =/- chemotherapy Exclusion Criteria: metastases history of fractures HRT or SERMs Liver or kidney disfunction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| 1: Low risk<br>Anastrozole 1mg/d, Vit D 400 IU and 500mg Calcium daily | |
| 2:Moderate risk<br>Anastrozole 1mg/d, Vit D 400 IU and 500mg Calcium daily, +/- Risedronate 35mg orally once a week | |
| 3:High risk<br>Anastrozole 1mg/d, Vit D 400 IU and 500mg Calcium daily, Risedronate 35mg orally once a week | |

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
-----------------
Arimidex, Bone Mineral density, Bisphosphonates, Aromatase Inhibitors
Safety and Efficacy of Bronchitol in Bronchiectasis

Study Overview
=================
Brief Summary
-----------------
Study will assess the safety and effectiveness of 12 week treatment with the study medication, Bronchitol, in subjects with bronchiectasis (a lung disease where patients have trapped, and often infected, thick, sticky mucus). Past studies have shown Bronchitol inhalation may help to facilitate the clearance of mucus by altering its rheology (making it less thick and sticky), thereby enhancing the shift of stagnant mucus from the lungs. On completion of the double blind phase, subjects will have the opportunity to participate in a 52 week open label phase.

Official Title
-----------------
A Phase III Multicenter, Randomised, Parallel, Placebo-Controlled, Double-Blind Study to Investigate the Safety and Efficacy of Treatment With Bronchitol (Dry Powder Mannitol) in the Symptomatic Treatment of Bronchiectasis.

Conditions
-----------------
Bronchiectasis

Intervention / Treatment
-----------------
* Drug: Mannitol
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non cystic fibrosis bronchiectasis Have FEV1 50% - 80% predicted and ≥1.0L Have chronic sputum production of >10 mL per day on the majority of days in the 3 months prior to study entry Exclusion Criteria: Be using hypertonic saline or mucolytic pharmacological agents concurrently or in the 4 weeks prior to study entry Have airway hyperresponsiveness as defined by a positive Aridol challenge

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Mannitol<br>* 320mg BD 12 weeks followed by 40 weeks open label<br>|
| Other: 2<br> | Drug: placebo<br>* BD for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour sputum clearance |  | 24 hours / 12 weeks | 
| Quality of Life SGRQ |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bronchiectasis symptoms |  | 12 weeks | 
| cough severity |  | 12 weeks | 
| exercise capacity |  | 12 weeks | 
| lung function, including gas transfer |  | 12 weeks | 
| antibiotic use |  | 12 weeks | 
| bronchial wall thickening and inflammation |  | 12 weeks | 
| adverse events |  | 12 weeks / 12 months | 
| haematology, biochemistry, |  | 12 weeks / 12 months | 
| sputum microbiology quantitative and qualitative |  | 12 weeks / 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mannitol
Assessment of the Health Improvement of Obese Patients After Fecal Microbiota Transplantation (FMT)

Study Overview
=================
Brief Summary
-----------------
Search for mechanisms of the effect of fecal microbiota transplantation on patients with obesity

Detailed Description
-----------------
To select recipients of fecal samples according to eligibility criteria; To perform fecal microbiota transplantation for patients with obesity; To analyze the efficacy of fecal microbiota transplantation for patients with obesity within six months after therapy.

Official Title
-----------------
Assessment of Improvement in Glycemic Control, Weight, and Insulin Sensitivity in Obese Patients After Fecal Microbiota Transplantation (FMT) Against the Background of Glucose-lowering Therapy

Conditions
-----------------
Obesity; Familial

Intervention / Treatment
-----------------
* Other: Fecal microbiota


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age of patients - from 18 to 75 years, both sexes; patients with obesity (body mass index ≥40 patient's informed consent to perform fecal microbiota transplantation Exclusion Criteria: presence of a concomitant chronic infectious disease or malignancy patients with a proven allergy to foods not excluded from the donor's diet absence of the patient for one or more intermediate stages of the examination. informed refusal to continue therapy

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two obese patients selected according to the inclusion criteria will undergo fecal microbiota transplantation from a healthy donor with a normal body mass index against the background of glucose-lowering therapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with diabetes mellitus type 1 (T1DM)<br>Treatment by transplantation of fecal microbiota | Other: Fecal microbiota<br>* Transplantation of fecal microbiota of healthy donor with normal body mass index<br>|
| Experimental: Patient with diabetes mellitus type 2 (T2DM)<br>Treatment by transplantation of fecal microbiota | Other: Fecal microbiota<br>* Transplantation of fecal microbiota of healthy donor with normal body mass index<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insulin sensitivity within FMT, 6 months after FMT] | participants will undergo euglycaemic glucose clamp study | 6 months after FMT |
A Study to Assess Beta-Lactam in the Treatment of Hospitalized Patients With Bacterial Pneumonia

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy and safety of intravenous beta-lactam, in comparison with ceftriaxone, in hospitalized patients with community-acquired pneumonia not caused by Legionella. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Official Title
-----------------
A Randomized, Double-blind Study of the Effect of Beta-lactam on Treatment Response in Patients Hospitalized With Bacterial Pneumonia

Conditions
-----------------
Pneumonia, Bacterial

Intervention / Treatment
-----------------
* Drug: Ceftriaxone
* Drug: beta-lactam
* Drug: beta-lactam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female patients at least 18 years of age; hospitalization with community-acquired pneumonia or development of pneumonia within 48 hours of being hospitalized for another reason; fever; new or increased productive cough; chest pain, shortness of breath, or rapid breathing. Exclusion Criteria: requiring intubation or ventilation; nursing home or extended care within 60 days before study; concomitant bacterial infection requiring antibiotics; long-term immunosuppressive therapy.

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: 1<br> | Drug: beta-lactam<br>* 750mg iv q 23h for 3-14 days<br>|
| Experimental: 2<br> | Drug: beta-lactam<br>* 1500mg iv q 12h for 3-14 days<br>|
| Active Comparator: 3<br> | Drug: Ceftriaxone<br>* 1000mg iv daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure rate\n\n |  | End of study visit (7-10 days after end of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, vital signs, laboratory parameters\n |  | Throughout study |