linjc16/ctgov huggingface dataset:
Nasal Irritation Study: Individual Factors in Nasal Irritant Sensitivity

Study Overview
=================
Brief Summary
-----------------
This study seeks to document differences in nasal irritant sensitivity within the population. The investigators are interested in knowing whether age, gender, and allergy status (nasal allergies) predict nasal irritant sensitivity. This is important in understanding symptom reporting patterns in air pollution situations (particularly in so-called problem buildings), as well as in understanding the reflex mechanism of a response of the nose to irritants (e.g., nasal congestion).

Official Title
-----------------
Individual Factors in Nasal Irritant Sensitivity

Conditions
-----------------
Rhinitis, Allergic, Nonseasonal

Intervention / Treatment
-----------------
* Procedure: Nasal irritation thresholds and irritant provocation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-smokers 18-69 years of age With or without allergic rhinitis (hay fever) In good general health and with no prior history of asthma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Nasal irritation thresholds and irritant provocation|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
-----------------
rhinitis, irritation, trigeminal
Study Evaluating the Safety and Efficacy of Piperacillin/Tazobactam and Ampicillin/Sulbactam in Patients With Diabetic Foot Infections

Study Overview
=================
Brief Summary
-----------------
Phase IV Open-Label Foot Infection Study is being conducted to generate comparative Efficacy and Safety data in Diabetic Inpatients.

Official Title
-----------------
An Open-label, Randomized Study Comparing the Efficacy and Safety of Piperacillin/Tazobactam and Ampicillin/Sulbactam Administered Intravenously in the Empirical Treatment of Foot Infections in Diabetic Inpatients

Conditions
-----------------
Diabetes Mellitus, Diabetic Foot

Intervention / Treatment
-----------------
* Drug: Piperacillin/Tazobactam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients with diabetes mellitus Inpatient Have 1 or more infected ulcer(s) below the ankle Exclusion Criteria Must not have gangrene or severely impaired arterial supply in your foot Must not have a bone infection in the area of your ulcer Must not have allergies to penicillins

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Piperacillin/Tazobactam|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
-----------------
Diabetes
Mesenchymal Stem Cells for the Treatment of Pneumonia Post Haematopoietic Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine whether mesenchymal stromal cell (MSC) treatment contribute to the good prognosis in patients with transplant-related complication, pneumonia post hematopoietic stem cell transplantation (HSCT).

Detailed Description
-----------------
Hematopoietic stem cell transplantation (HSCT) is a standard therapy strategy for most hematologic disorders and malignancies. Despite the improved survival attributed to advances in HSCT including transplantation techniques and supportive care, transplant-related pneumonia (severe pneumonia in particular) remains the leading cause of death for most HSCT patients and a major challenge for clinicians. Mesenchymal stromal cells (MSCs), a form of multipotent cells, have been applied in therapy for various intractable disorders. MSC exerts its therapeutic effect through various biological functions including immunoregulation, tissue repairing, self-renew and differentiating into various cell lines. The American Thoracic Society has also suggested MSCs as a cell therapy agent for lung diseases. However, MSC therapy for pneumonia following HSCT has not been well investigated. By investigating the efficacy of MSC treatment for HSCT-related pneumonia via comparing the outcomes in patients with and without MSC treatment, this study will provide a promising therapy for HSCT-related pneumonia.

Official Title
-----------------
Mesenchymal Stem Cells for the Treatment of Pneumonia Post Haematopoietic Stem Cell Transplantation: a a Retrospective Cohort Study

Conditions
-----------------
Pneumonia, Hematopoietic Stem Cell Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with pneumonia after HSCT; patients under the age of 18 years; patients with normal pulmonary function before HSCT. Exclusion Criteria: patients with other severe complications in progress when pneumonia occurred.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 17 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 |
| --- | --- |
| mesenchymal stromal cell<br>Patients treated with mesenchymal stromal cell | |
| non-mesenchymal stromal cell<br>Patients treated without mesenchymal stromal cell | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall cure rate | the proportion of cured cases in all cases | 12 months | 
| time to cure | the time from the first diagnosis of pneumonia to a cure was achieved | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mesenchymal Stromal Cell, Pneumonia, Hematopoietic Stem Cell Transplantation
Peripheral Histamine 1 Receptor Blockade in IBS: Multicenter Trial

Study Overview
=================
Brief Summary
-----------------
Purpose: To evaluate the efficiency of Irritable Bowel Syndrome (IBS) patients treatment with the H1-receptor antagonist ebastine. Design: Double blind randomized placebo controlled trial. IBS patients receive a 12-weeks treatment with ebastine 20mg once daily or placebo (1:1 randomization).

Official Title
-----------------
Peripheral Histamine 1 Receptor Blockade in IBS

Conditions
-----------------
Irritable Bowel Syndrome (IBS)

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Irritable Bowel Syndrome (IBS) (ROME III criteria): subtype with diarrhea or mixed form age 18-65 years Exclusion Criteria: IBS subtype with constipation medication: antidepressants or H1-receptor antagonists pregnancy, breast feeding co-morbidity: severe kidney- and/or liver disease or other gastrointestinal diseases

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ebastine<br>Ebastine | Drug: Ebastine<br> <br> |
| Placebo Comparator: placebo<br>Placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of treatment on global symptom relief (of IBS complaints) | By mean of weekly GSRS (Gastrointestinal Symptom Rating Scale )questionnaires and weekly SGA (Subject's Global Assessment) of relief and SGA of Abdominal Pain and Discomfort questionnaires | after 12 weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of treatment on stool consistency and frequency and other common IBS associated complaints (flatulence, urgency,...) | By mean of weekly questionnaires | fter 12 weeks treatment |
Music Imagery for Patients Receiving Chemotherapy for Leukemia or Non-Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the effect of music imagery on patients receiving intensive chemotherapy for acute leukemia or high-grade non-Hodgkin's lymphoma.

Detailed Description
-----------------
Standard treatment for acute leukemia and high-grade non-Hodgkin's lymphoma includes intensive chemotherapy that typically requires a 4-week hospital stay in protective isolation. Patients treated in isolation units may experience elevated levels of psychological distress. Both guided imagery and music therapy have been effective in improving the moods of cancer patients, but studies have not been conducted in acute leukemia and non-Hodgkin's lymphoma patients. This study will evaluate the effect of music imagery on these patients. Participants in this study will be randomly assigned to receive either standard care plus music imagery or standard care alone. Participants assigned to the standard care plus music imagery group will receive a 45-minute weekly music imagery session with a music therapist. All participants will complete questionnaires and self-reports regarding their general anxiety, affect, and fatigue.

Official Title
-----------------
Music Imagery for Patients in Protected Environments

Conditions
-----------------
Leukemia, Lymphoma, Non-Hodgkin

Intervention / Treatment
-----------------
* Behavioral: Music Imagery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted to Indiana University Hematologic Malignancy Program for the treatment of newly diagnosed or recurrent acute leukemia or high-grade non-Hodgkin's lymphoma Able to read and understand English

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Music Imagery|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
-----------------
Music Therapy, Anxiety, Depression
The Effects of Celecoxib on Bone Ingrowth

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of Celebrex on bone growth into porous coated implants, following postoperative total knee arthroplasty administration of Celebrex for pain relief.

Official Title
-----------------
The Effects of Celecoxib on Bone Ingrowth in Porous Coated Titanium Ceramic Implants in Humans

Conditions
-----------------
Bone Ingrowth, Pain

Intervention / Treatment
-----------------
* Drug: Celecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male VA bilateral TKA patients 18 years or older with primary OA diagnosis Exclusion Criteria: Patients with osteoporosis, hypersensitivity to Celebrex, allergy to tetracycline, Sulfonamides, patient with asthma, urticaria, or allergic-type reactions to aspirin or NSAIDs. Patients who have had CABG. Patients with a history of peptic ulcer disease, duodenal ulcers. Female patients and patients diagnosed with unstable hypertension or hypotensive, with serum creative levels above 1.8-2.0 or diagnosed with severe renal disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm #1<br>Celebrex treatment group | Drug: Celecoxib<br>* Twelve hours prior to their first total knee surgery, patients will need to take an oral dose of Celebrex, 1 pill of 200mg. Following the patient's first total knee surgery, they will continue taking oral doses of Celebrex, 1 pill of 200 mg every twenty-four hours (200mg/day) for a two-week period.<br>* Other names: Celebrex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Ingrowth |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score |  | 10 days postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Celebrex, Bone Ingrowth, Pain relief
Employment and Quality of Life in Patients With Malignant Melanoma

Study Overview
=================
Brief Summary
-----------------
Within the first year after diagnosis, data on employment and quality of life will be collected and evaluated in patients with malignant melanoma

Official Title
-----------------
A Prospective Cohort Study on Employment and Quality of Life in Patients With Malignant Melanoma

Conditions
-----------------
Malignant Melanoma of Skin, Quality of Life, Work Ability

Intervention / Treatment
-----------------
* Behavioral: Quality of Life, status of employment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first diagnosis of malignant melanoma stage 0 to stage IIIC within the last 6 weeks written informed consent Exclusion Criteria: diagnosis of malignant melanoma stage IV inability to follow the protocol

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Quality of Life, status of employment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life questionnaire |  | one year |
Validation of Drug Assays in Various Biological Matrices

Study Overview
=================
Brief Summary
-----------------
This study aims to ensure that assays that measure drug concentrations are accurate and precise in different matrices when quantified using high performance liquid chromatography -tandem mass spectrometry (HPLC-MS/MS). The study involves collecting samples of various bodily fluids to quantify antimicrobials, antivirals, oral contraceptives and erectile dysfunction agents. Samples will also be obtained from individuals not receiving these medications for quality control purposes.

Official Title
-----------------
Validation of Drug Assays in Various Biological Matrices

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Other: antivirals, antimicrobials, oral contraceptive, erectile dysfunction agents


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years of age Exclusion Criteria: Unable to give informed consent

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

| Intervention/Treatment |
| --- |
|Other: antivirals, antimicrobials, oral contraceptive, erectile dysfunction agents|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure drug concentrations using high performance liquid chromatography -tandem mass spectrometry (HPLC-MS/MS) (accuracy and precision of assays that measure drug concentrations) | Assay validation | Follow up up to 5 years |
Analysis of Biomarkers in Lymph Node Tissue

Study Overview
=================
Brief Summary
-----------------
Researchers are doing an exploratory analysis of biomarkers to correlate with treatment outcome of transplant surgery.

Detailed Description
-----------------
Researchers will study previously collected tissue, which was sent for pathological examination, of 200 patients who underwent transplant surgery. Concentration of biomarkers in lymph node tissue will be measured.

Official Title
-----------------
Analysis of Biomarkers in Lymph Node Tissue

Conditions
-----------------
Analysis of Biomarkers in Lymph Node Tissue

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (18+years of age) Undergo any organ transplant Exclusion Criteria: Under the age of 18 years old

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 |
| --- | --- | --- |
| List of biomarkers | Immunohistochemistry (IHC) for the LYVE1, VEGFR3 expression, VEGF-A/C/D, Ki-67, MMP-9 and TIMP-1 | Baseline |
Cidofovir as a Treatment for Herpes Simplex in Patients With AIDS

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if cidofovir gel (Forvade) is safe and effective in treating herpes simplex in patients with AIDS who do not respond to acyclovir.

Detailed Description
-----------------
Patients receive open-label treatment with cidofovir gel.

Official Title
-----------------
Open-Label Study of Cidofovir Gel for Acyclovir-Unresponsive Mucocutaneous Herpes Simplex Disease in Patients With AIDS.

Conditions
-----------------
Herpes Simplex, HIV Infections

Intervention / Treatment
-----------------
* Drug: Cidofovir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: AIDS diagnosis per CDC criteria. At least partially external mucocutaneous HSV infection confirmed by culture of current outbreak. Current HSV outbreak that is unresponsive to >= 10-day course of acyclovir at 1-4 gm/day po or 15 mg/kg/day IV or in vitro resistance of HSV isolate to acyclovir demonstrated within 60 days of study. Signed, informed consent from parent or legal guardian for patients less than 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Evidence of cervical intraepithelial neoplasia class III (CIN III) on Pap smear (Pap smear required within 6 months of starting study drug). Concurrent Medication: Excluded: Acyclovir, valacyclovir, famciclovir, ganciclovir, foscarnet, topical trifluride, cidofovir injection or other systemic or topical drugs with anti-herpes activity. Required: >= 10 day course acyclovir at 1-4 gm/day po or 15mg/kg/day IV (not required if there is confirmed in vitro resistance to acyclovir).

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cidofovir|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
-----------------
AIDS-Related Opportunistic Infections, Herpes Simplex, Acyclovir, Antiviral Agents, Gels, cidofovir
Effectiveness of the TB Contact Priority Model

Study Overview
=================
Brief Summary
-----------------
The broad purpose of this project, proposed by investigators at the University of Alabama at Birmingham and the State of Alabama Department of Public Health, is to use a behaviorally focused education that has been proven effective to enhance the accuracy and efficiency of the contact investigation process. The behaviorally focused intervention will focus on enabling public health workers to understand and implement a recently published model of TB transmission.

Detailed Description
-----------------
BACKGROUND: Investigation of contacts of patients with active pulmonary tuberculosis (TB) is an important epidemiological tool in TB control. Unfortunately, due to budgetary and resource constraints, many health departments struggle to fulfill their responsibility of TB control through contact investigation. DESIGN NARRATIVE: Primary outcome The primary outcome of this project is to examine the clinical effectiveness of the TB transmission model. This will be done by examining the sensitivity and specificity of the model when used in a field application. Key secondary outcomes Evaluation of the efficiency of contact investigation (two outcomes: 1) weekly average time to tuberculin skin test placement for high risk contacts, 2) weekly average time to the close of the contact investigation.) Qualitative assessment of individuals who are incorrectly predicted by the model to have a negative tuberculin skin test

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Behavioral: TB Contact Priority Model


Participation Criteria
=================
Eligibility Criteria
-----------------
B field workers for the Alabama Department of Public Health.
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: TB Contact Priority Model|nan|

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

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