linjc16/ctgov huggingface dataset:
The Ohio State University Dermatology Biorepository

Study Overview
=================
Brief Summary
-----------------
This study will create and extend a source of clinical specimens for the future study of inflammatory skin disorders.

Detailed Description
-----------------
A variety of molecular techniques can be used to investigate diseases by analyzing protein, DNA, and RNA. Flow cytometry, Polymerase chain reaction (PCR), histology and immunohistochemistry are assays which can identify specific cell populations and provide valuable information regarding the pathologic characteristics of those populations. Flow cytometry analyzes the surface markers of cells. Histology and immunohistochemistry further characterize surface and cellular molecules and aid in the diagnosis of certain skin diseases. Gene expression profiling allows investigators to examine the genes detectable to determine the function of the cells involved, and PCR techniques are useful for the diagnosis of certain conditions and for DNA analysis. By procuring blood, skin tissue, and swab samples from patients with and without neoplastic and inflammatory skin disorders at the time of their appointments, the hypothesize that future translational research can be conducted on such specimens using the aforementioned techniques to further understand disease mechanisms in cutaneous disorders, and to potentially discover defective function and genetic mutations within cells from patients with neoplastic and inflammatory skin disorders. By establishing a tissue bank, we aim to lay the foundation for future work that will improve our understanding of the biology and natural history of neoplastic and inflammatory cutaneous diseases.

Official Title
-----------------
The Ohio State University Dermatology Biorepository

Conditions
-----------------
Hidradenitis Suppurativa

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Seen by an Ohio State University (OSU) Dermatology provider on the main University Hospital campus, including the James Cancer Hospital, OSU Dermatology East, OSU Dermatology at the Ohio State Eye and Ear Institute, Martha Morehouse Medical Pavilion, and OSU Dermatology at Upper Arlington after the date of approval of this protocol Ability to provide informed consent, or parent or legal guardian capable of providing consent for child or mentally handicapped individuals Willingness to participate in a research study. Exclusion Criteria: Inability to provide informed consent
Sexes Eligible for Study
-----------------
All

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Source of clinical specimens for the future study of neoplastic and inflammatory skin disorders |  | 5 years |
Nebulized Beclomethasone Dipropionate Improves Respiratory Lung Function in Preschool Children With Recurrent Wheezing

Study Overview
=================
Brief Summary
-----------------
This is a single-centre, open label study, aiming to evaluate the efficacy of beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg nebulized), on airway resistance and reactances (measured with Rint and FOT techniques) in children with recurrent wheezing, aged 2-5 years. In addition, clinic score as frequency of symptoms and exacerbations, will be assessed.

Official Title
-----------------
Nebulized Beclomethasone Dipropionate Improves Respiratory Lung Function in Preschool Children With Recurrent Wheezing

Conditions
-----------------
Wheezing

Intervention / Treatment
-----------------
* Drug: Nebulized beclomethasone dipropionate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed and subscribed consent before any procedure Age range : 2 - ≤5 years Male and female patients Recurrent wheezing affected ( ≥ 4 episodes in the last 12 months) PAI positive (at least one primary and two secondary ): Primary: one parent with asthma Atopic Dermatitis sensibilisation to air allergen Secondary: Food sensibilization wheezing also not during the infective episodes eosinophilia (>4%) Exclusion Criteria: story of severe wheeze requiring hospitalization treatment with inhaled glucocorticoids during the previous 4 weeks or with oral glucocorticoids in the previous 8 weeks structural abnormalities of the lungs (tracheobronchial bronchomalacia, external compressions, etc) Persistent infections aspiration lung disease (gastroesophageal reflux disease, etc.) Cystic fibrosis prematurity or bronchopulmonary dysplasia Tuberculosis primary ciliary dyskinesia congenital heart disease pulmonary foreign body bronchiectasis Immunodeficit

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 Years

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

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: Nebulized Beclomethasone dipropionate<br>Nebulized Beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg). | Drug: Nebulized beclomethasone dipropionate<br>* Nebulized beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg)<br>* Other names: BDP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung fuction with Rint and FOT |  | 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wheezing, Children
Anterior Minimal Invasive Surgery Versus Antero-lateral Approach in Hip Joint Hemiarthroplasty

Study Overview
=================
Brief Summary
-----------------
Comparison between two minimally invasive approaches to the hip joint.

Detailed Description
-----------------
Following parameters were compared: modified Barthel-Index, pain, complications, developing of heterotopic ossification.

Official Title
-----------------
Anterior Minimal Invasive Surgery Versus Antero-lateral Approach in Hip Joint Hemiarthroplasty

Conditions
-----------------
Arthroplasty, Clinical Outcome

Intervention / Treatment
-----------------
* Procedure: Anterior versus lateral approach to hip joint


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria: Exclusion criteria represented acute local or systemic infection, open or pathological fractures, concomitant injuries of the ipsi- or contralateral leg and rheumatoid arthritis.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anterolateral approach<br> | Procedure: Anterior versus lateral approach to hip joint<br> <br> |
| Direct anterior approach<br> | Procedure: Anterior versus lateral approach to hip joint<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | Pain score | one year after surgery |
Pierre Robin Sequence Outcome Assessment Multi Institutional Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective, multi-center, longitudinal study is to assess clinical outcomes related to the surgical treatment of PRS ( Pierre Robin Sequence) by MDO (Mandibular distraction osteogenesis). This study aims to develop a scoring system to determine success and complication rate pre and post MDO.

Detailed Description
-----------------
The recruitment phase of this trial is 3 years. Duration of the trial is 19 years. All study patients who undergo mandibular distraction will be indicated for surgery following published and accepted protocols of care for mandibular distraction in this specific patient population. There will be no experimental/treatment arms in this study. All patients will undergo standard of care interventions and assessments that would not change if the patient were not to participate in this study. The purpose of this study is to follow multiple surgical outcomes following these standard of care practices. The methods and procedures detailed below follow published and accepted standards of care.

Official Title
-----------------
Pierre Robin Sequence Outcome Assessment Multi Institutional Study (PROMIS)

Conditions
-----------------
Pierre Robin Sequence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed Consent/Assent Form All patients with PRS as defined by mandibular hypoplasia, glossoptosis causing airway obstruction, who undergo MDO prior to the age of 6 months, will be included in the study. This will include all infants regardless of syndromic diagnosis, other organ system abnormalities, cleft palate diagnosis or the presence of other concurrent craniofacial anomalies. Exclusion Criteria: Infants over the age of 6 months patients who undergo mandibular distraction for conditions other than Pierre Robin sequence. Patient who refuse to be included in this study

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 6 Months

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 |
| --- | --- | --- |
| Development of Functionality over time | We will monitor changes in maxillofacial development, functionality and surgical complications | Q 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cleft Palate Repair outcome | Incidence of airway complications, Incidence of fistula and fistula location | 1 year |
Green Tea in Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether green tea or coffee influence the course and life quality of patients with mild to moderately active Crohn's disease.

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Other: Green tea (Camellia sinensis)
* Other: Coffee


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women and men ≥ 18 years with signed informed consent, Patients with proven Crohn's disease, Chronic-active course ≥ 3 months, Current CDAI ≥ 150 and ≤ 350, All medications for Crohn's disease have to be on a constant dosage for at least 4 weeks prior to study entry (i.e. 5-ASA, steroids), Ability of the participant to understand character and individual consequences of the study. Exclusion Criteria: Pregnancy or the wish to become pregnant, breastfeeding, Concomitant treatment with methotrexate, azathioprine or 6-mercaptopurine for < 3 months, Treatment with TNF-alpha-antagonists, cyclosporine or tacrolimus < 4 weeks prior to study entry, Participation in another study within the last 4 weeks, Ulcerative colitis or indeterminate colitis, Infectious colitis, including cytomegalovirus or Clostridium difficile induced colitis, Colitis for other reasons like known diverticulitis, radiation colitis, ischemic colitis or microscopic colitis, Malabsorption syndromes, lactose intolerance, celiac disease, exocrine pancreas insufficiency, Bleeding hemorrhoids, Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding, Intolerance / aversion to tea and/or coffee, Current treatment with antibiotics.

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: green (or white) tea<br>Patients are recommended to drink green (or white) tea but are not allowed to consume any coffee | Other: Green tea (Camellia sinensis)<br>* Patients are recommended to drink at least 5 cups of green tea per day<br>|
| Other: coffee<br>Patients are recommended to drink coffee but are not allowed to consume any tea | Other: Coffee<br>* Patients are recommended to drink as much coffee as they tolerate.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crohn's Disease Activity Index | Assessment of clinical activity | week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harvey-Bradshaw-Index | Assessment of clinical activity | week 16 | 
| Inflammatory Bowel Disease Questionnaire | Assessment of Life Quality | week 16 |
Evaluation of Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients

Study Overview
=================
Brief Summary
-----------------
In the present study we are planning to study electrophysiological changes related to the dose and time of bortezomib administration in newly diagnosed patients with MM, during the first months of treatment and 6 months after ending. In addition a possible correlation between the incidence of BIPN and the subtype of myeloma and other risk factors will be investigated.

Official Title
-----------------
Phase 3 Study to Evaluate Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients.

Conditions
-----------------
Multiple Myeloma, Peripheral Neuropathy

Intervention / Treatment
-----------------
* Procedure: EMG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age> 18 Patients with Multiple Myeloma stage II, III (Durie and Salmon staging) prior to Bortezomib Therapy Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Be willing and able to comply with the protocol treatment for the duration of the study Patient's written informed consent Exclusion Criteria: Multiple Myeloma on progression Incidence of Relapsed or Refractory Myeloma Patients with the existing neuropathy at the time of the diagnosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: EMG|Nerve conduction study will be consisted of sequential evaluation of the motor nerves: median, ulnar, peroneal and tibial; and the sensory nerves: median, ulnar, superficial peroneal and sural nerves using a standardized protocol|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A dose-related neurotoxic effect of bortezomib will be determined through regression analysis with the change in TNSr as the dependent variable Bortezomib doses will use as independent variables. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To accommodate the dose of bortezomib with the progression of Peripheral Neuropathy |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Myeloma, Bortezomib, Peripheral Neuropathy, evaluation, evaluation of electrophysiological changes related to the dose and time of bortezomib administration, investigation of correlation between the incidence of BIPN and the subtype of myeloma
Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Objective: to evaluate the bioavailability of subcutaneous granisetron.Patients receiving platinum-based chemotherapy will be randomized to receive granisetron 3 mg either subcutaneously or intravenously in a crossover manner during two cycles. Blood and urine samples will be collected after each cycle.

Detailed Description
-----------------
5-HT3 antagonists are one of the mainstays of antiemetic treatment and they are administered either intravenously or orally. Nevertheless sometimes neither administration route is feasible, such as in patients unable to admit oral intake managed in an outpatient setting. Our objective is to evaluate the bioavailability of subcutaneous granisetron.Patients receiving platinum-based chemotherapy will be randomized to receive granisetron 3 mg either subcutaneously or intravenously in a crossover manner during two cycles. Blood and urine samples will be collected after each cycle. Pharmacokinetics of SC and IV granisetron will be prospectively compared.

Official Title
-----------------
Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients Treated With Platinum Based Chemotherapy

Conditions
-----------------
Vomiting

Intervention / Treatment
-----------------
* Drug: granisetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cancer patients receiving platinum-based chemotherapy adequate bone marrow, hepatic and renal function, respectively defined by: platelets >100000/mm3 and absolute neutrophil count >1500/mm3; bilirubin, AST and ALT <2 times x upper limit of normality; and creatinine <1.5 mg/dl. ECOG performance status <2 and body mass index from 20-28 kg/m2. Exclusion Criteria: Pregnancy Serious concomitant diseases, in the invesgator´s criteria

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Granisetron SC-Granisetron IV<br>Granisetron SC followed by Granisetron IV | Drug: granisetron<br>* Granisetron SC followed by granisetron IV<br>* Other names: Granisetron SC followed by granisetron IV;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability |  | Approximately 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | Approximately 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
emesis, granisetron, pharmacokinetics, subcutaneous.
Hematuria Evaluation Trial for Subjects With Microscopic or Gross Hematuria to Determine the Absence or Presence of Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate subjects with gross or microscopic hematuria undergoing scheduled cystoscopy to determine the absence or presence of bladder cancer.

Official Title
-----------------
Phase 3 Study of Hematuria Evaluation

Conditions
-----------------
Microscopic or Gross Hematuria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For those subjects for whom there is no family history of bladder cancer or less than a 20 pack year history of cigarette smoking, subject must be 50 or older. Subject's age can be lowered to 45 or older if there is a family history of bladder cancer and/or a 20 or greater pack history of cigarette smoking. Subject must have an intact bladder Subject must be scheduled to have a cystoscopy to screen for transitional call bladder cancer due to the finding of hematuria. Subject must be able to provide a minimum of 25 mL of urine for study purposes. Urine samples must be available prior to cystoscopy, bladder biopsy, and TUR. Subjects must be willing to sign an Institutional Review Board approved written informed consent prior to any study related procedures being performed. Exclusion Criteria: Subject had a history or current diagnosis of any basal or squamous cell cancer. Subject had a known diagnosis of any autoimmune disease. Subject had known diagnosis of HIV, HCV or HBV Subject had disclosed voluntarily history of or current infection with TB or other systemic disease. Subject is currently pregnant or lactating. Subject had surgery within 30 days prior to enrollment Subject has known allergy to benzalkonium chloride. Subject participated in an investigational drug or device trial within 30 days prior to enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- |
| Subjects with hematuria<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the performance characteristics of the Predictive Biosciences Assay relative to the cystoscopy results for subjects undergoing evaluation for the referral diagnosis of gross or microscopic hematuria |  | Initial Visit only | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the performance characteristics of the PB assay relative to urine cytology results for subjects undergoing evaluation for the referral diagnosis of gross or microscopic hematuria. |  | Initial Visit |