linjc16/ctgov huggingface dataset:
Do Oral Steroid Dose Packs Predict How Well Epidural Steroid Injections Will Work?

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to show whether a standard oral steroid dose pack can be used as a screening tool to assess the effectiveness of a subsequent epidural steroid injection (ESI). If an oral steroid does not give a patient significant temporary relief of pain from a herniated lumbar disc then an epidural steroid injection will not either. Therefore the risk and expense associated from the interventional pain management procedure for those patients could be avoided and other treatment modalities pursued.

Official Title
-----------------
Oral Steroid Dose Pack Used As A Predictor For The Effectiveness Of Epidural Steroid Injections

Conditions
-----------------
Lumbar Spine Disc Herniation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older Diagnosed by participating physicians during the study enrollment period as having intervertebral disk herniation and persistent symptoms with or without some nonoperative treatment for at least 4 weeks Radicular pain (below the knee for lower lumbar herniations, into the anterior thigh for upper lumbar herniations) Evidence of nerve-root irritation with a positive nerve-root tension sign (straight leg raise-positive between 30° and 70°) or a corresponding neurologic deficit (asymmetrical depressed reflex, decreased sensation in a dermatomal distribution) Undergone either MRI or CT scan showing disc herniation (protrusion, extrusion, or sequestered fragment) at a level and side corresponding to the clinical symptoms Patients with multiple herniations can be included if only one of the herniations is considered symptomatic Preenrollment nonprocedural care can include: education/counseling, physical therapy, chiropractic therapy, anti-inflammatory medications, opioid analgesics, adjuvant analgesics such as anticonvulsants and antidepressants Exclusion Criteria: Prior lumbar surgery Cauda equina syndrome Vertebral fractures Spine infection or tumor Severe motor deficit Inflammatory spondyloarthropathy Pregnancy Cardiac or pulmonary comorbid conditions contraindicating interventional procedures Diabetes Inability/unwillingness to have spinal injections

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 |
| --- | --- | --- |
| Change in Patient-Reported Pain | The primary endpoint will be a patient-reported pain as measured by a 10 cm visual analog scale (VAS) with 0 being no pain and 10 being the most severe pain imaginable. | Baseline,1 wk post oral steroid completion, 2 wks post ESI #1, 2 wks post ESI #2, 2 wks post ESI #3, then at 6 wks, 12 wks, 6 mo. & 12 mo. after last transforaminal ESI (TRESI). |
SEMS Placement Followed by Chemotherapy and Surgery for Obstructing Left-sided Colonic Cancer

Study Overview
=================
Brief Summary
-----------------
This study aimed to evaluate the safety and feasibility of SEMS followed by neoadjuvant chemotherapy prior to elective surgery for obstructing left-sided colon cancer.

Detailed Description
-----------------
Stoma is reported to be frequent in self-expanding metallic stent (SEMS) treated patients with obstructing left-sided colon cancer than in those with non-obstructing surgery. Retrospective study reported worse overall survival with SEMS and elective surgery than with emergency surgery in patients with left-sided malignant colon obstruction. In practice, intestinal wall edema following stent placement increases the difficulty of surgery, and this could be a major problem if the interval between stent insertion and surgery is short (1-2 weeks). The patients with obstructing left-sided colon cancer received SEMS treatment, and the recevied neoadjuvant chemotherapy prior to elective surgery.

Official Title
-----------------
Self-expanding Metallic Stent Placement Followed by Neoadjuvant Chemotherapy and Scheduled Surgery for Treatment of Obstructing Left-sided Colonic Cancer

Conditions
-----------------
Complication of Treatment

Intervention / Treatment
-----------------
* Combination Product: self-expanding metallic stent placement followed by neoadjuvant chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically proven adenocarcinoma located in the left colon (between the splenic flexure and 15 cm proximal to the anal margin) Eastern Cooperative Oncology Group (ECOG) performance status of from 0 to 2 Exclusion Criteria: history of any other cancer multiple primary colorectal cancers distant metastases hereditary nonpolyposis colorectal cancer familial adenomatous polyposis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Combination Product: self-expanding metallic stent placement followed by neoadjuvant chemotherapy|Neoadjuvant chemotherapy was administered 1 week after successful SEMS placement and decompression for patient with obstructing left-sided colonic cancer. Patients received either three cycles of mFOLFOX6 repeated every 2 weeks or two cycles of CAPOX repeated every 3 weeks. Elective surgery was performed 2 weeks after completion of chemotherapy by experienced colorectal surgeons.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stoma rate | stoma rate after surgery | 3 years after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stoma, Left-sided colonic tumor, Intestinal obstruction, Self-expanding metallic stent, Neoadjuvant chemotherapy
Genomics of Primary Sclerosing Cholangitis (PSC)

Study Overview
=================
Brief Summary
-----------------
Primary Sclerosing Cholangitis (PSC) is a progressive liver disorder of unknown cause. Current evidence suggests that genes, the genetic material we inherit from our parents, in combination with environmental factors, likely play an important role in the development of PSC. This study is being done to investigate whether genes make people more likely to develop PSC. Discovery of these genes will help us to better understand how PSC developes and subsequently, to apply new approaches for its prevention, diagnosis and treatment.

Official Title
-----------------
P.R.O.G.R.E.S.S.: PSC Resource Of Genetic Risk, Environment and Synergy Studies.

Conditions
-----------------
Primary Sclerosing Cholangitis (PSC)

Intervention / Treatment
-----------------
* Genetic: Genetic Analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men, Women, and Children between the ages of 5-90 with a history of PSC. PSC patients who have had a liver transplant are eligible. Family members (1st degree relatives) of enrolled PSC patients are eligible. Exclusion Criteria: Individuals with no history of PSC or those unable to provide consent.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: Genetic Analysis|Perform Genome Wide Association Studies.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mapping of Susceptibility Genes in Adult Chronic Cholestatic Liver Diseases | Adult chronic cholestatic liver diseases, such as Primary Sclerosing Cholangitis (PSC), are progressive liver disorders of unknown cause. Current evidence suggests that genes, the genetic material we inherit from our parents, in combination with environmental factors, likely play an important role in the development of PSC. This study is being done to investigate whether genes (the inherited genetic material passed from parents to their children) make people more likely to develop PSC. Discovery of these proposed genes will help us to better understand how PSC progresses, |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Sclerosing Cholangitis, PSC, Cholestatic Liver Disease
A Study Comparing Amounts of Tafamidis In The Blood Without Food

Study Overview
=================
Brief Summary
-----------------
3 different formulations and doses of tafamidis will be compared. Subjects will be fasted for each test and every subject will test all 3 different formulations. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for 6 days. After 14 days, subjects will take a different formulation of tafamidis and tafamidis blood concentrations will be measured periodically for 6 days. After another 14 days, the last formulation will be tested in the same way.

Official Title
-----------------
A Phase 1, Open-Label, Three Period Randomized, Single Dose Study To Estimate The Relative Bioavailability Of Pf-06291826 (Tafamidis) Free Acid Tablet Formulation Versus Commercial Capsule In Healthy Subjects Under Fasted Conditions

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: tafamidis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males or females of non-child bearing potential. Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110 lbs). Exclusion Criteria: Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic). Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days of the study. Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 48.8 mgA tafamidis free acid tablet<br> | Drug: tafamidis<br> <br> |
| Experimental: 58 mgA tafamidis free acid tablet<br> | Drug: tafamidis<br> <br> |
| Experimental: 4 soft gel capsules of 20 mg tafamidis meglumine<br> | Drug: tafamidis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time Curve (AUC) |  | 120 hours | 
| Maximum Observed Plasma Concentration (Cmax) |  | 120 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |  | 120 hours | 
| Mean residence time (MRT) |  | 120 hours | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 120 hours | 
| Plasma Decay Half-Life (t1/2) |  | 120 hours |
Biting Force in Heat Cured Acrylic Resin Versus CAD/CAM Maxillary Single Denture Bases

Study Overview
=================
Brief Summary
-----------------
measuring difference in biting force between (computer aided design/computer aided manufacturing) maxillary dentures and conventional ones.

Detailed Description
-----------------
measuring difference in biting force using i-load device with followup period of 6 months

Official Title
-----------------
Biting Force in Heat Cured Acrylic Resin Versus CAD/CAM Maxillary Single Denture Bases: A Randomized Controlled Trial .

Conditions
-----------------
Bites, Human

Intervention / Treatment
-----------------
* Other: cad/cam maxillary dentures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with completely edentulous maxillary ridge with minimum undercuts, opposing a partially edentulous ridge. Mean age of 50-75 years of age. The edentulous ridges should be covered by firm healthy mucosa. Systemically free; no history of diabetes, chemotherapy, and radiotherapy. Co-operative patients. Exclusion Criteria: Patients with severely resorbed maxillary ridge Previous history of radiotherapy or chemotherapy. Patients with xerostomia Patients with neuromuscular and hormonal disorders Patients with severe bony or soft tissue undercuts Patients with large tongue Patients with limited mouth opening Patients with known history of allergy, especially to acrylic resin

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cad/cam maxillary dentures<br>single maxillary dentures fabricated by cad/cam method | Other: cad/cam maxillary dentures<br>* patients wearing cad/cam designed and milled dentures<br>|
| Active Comparator: conventional dentures<br>heat cured single maxillary dentures | Other: cad/cam maxillary dentures<br>* patients wearing cad/cam designed and milled dentures<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biting Force in Heat Cured acrylic resin versus CAD/CAM Maxillary Single Denture Bases |  | 6 month |
Longitudinal Pathogen-colonization in Cystic Fibrosis Airways and Ability to Smell

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to detect the prevalence of chronic rhinosinusitis, pathogen colonization of the lower and upper airways and, in a sub-cohort the sense of smelling in patients with cystic fibrosis.

Detailed Description
-----------------
The sub-study on the sense of smelling in CF has been finalized in the meantime. Results were published in 2012: Smell in cystic fibrosis. Lindig J, Steger C, Beiersdorf N, Michl R, Beck JF, Hummel T, Mainz JG. Eur Arch Otorhinolaryngol. 2013 Mar;270(3):915-21. doi: 10.1007/s00405-012-2124-2. Epub 2012 Aug 14.

Official Title
-----------------
Prevalence of Chronic Rhinosinusitis, Pathogen-colonization in the Upper and Lower Airways and Ability to Smell in Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis With Other Manifestations, Sinusitis

Intervention / Treatment
-----------------
* Other: nasal lavage and sputum collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has a confirmed diagnosis of cystic fibrosis
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CF patients of all age groups<br>Longitudinal prospective assessment of upper and lower airway colonization in all patients attended in the Jena University CF centre | Other: nasal lavage and sputum collection<br>* non-invasive longitudinal assessment of pathogen colonization in both airway levels<br>* Other names: Pseudomonas aeruginosa antibodies in serum;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamics in CF upper and lower airway colonization with pathogens | longitudinal non-invasive sampling of upper and lower airways in CF | 10 years | 
| Assessment of ability to smell in CF patients |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary function / BMI |  | 10 years |
Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice.

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, randomized, double blind, vehicle controlled, study designed to evaluate the pediculicidal activity of Summers 5% L.A. compared to a vehicle control.

Official Title
-----------------
A Multi-Center, Randomized, Vehicle Controlled, Double Blind Clinical Trial to Evaluate the Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.) for the Treatment of Head Lice.

Conditions
-----------------
Head Lice

Intervention / Treatment
-----------------
* Drug: Summers 5% L.A.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females 6 months of age or older. Have an active infestation with pediculus capitis, the human head louse, with at least three live lice at baseline. Agree not to use any other pediculicides or medicated hair-grooming products during the duration of the study. Be healthy, non-febrile, and not suffering from an infection likely to require antibiotic therapy during the study period. Subject or guardian is able to understand the new HIPAA regulations and sign the HIPAA form. Subject or guardian has read, understood, and signed appropriate informed consent in English. If English is not the primary language, the information about the study must be explained in their language and a copy of the informed consent must be in that language. Subject is willing to participate in the study, and abide by the protocol requirements. - Exclusion Criteria: Participation in any clinical study within the past 30 days. Known hypersensitivity to any ingredient in the product formulation.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months

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

| Intervention/Treatment |
| --- |
|Drug: Summers 5% L.A.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success is defined as the absence of live lice. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cumulative proportions of subjects determined to be treatment failures at the Second Evaluation Visit. |  |  |
Therasphere for Unresectable Primary or Secondary Liver Neoplasia

Study Overview
=================
Brief Summary
-----------------
This is not a research study. The purpose is to provide supervised access to TheraSphere® therapy at this institution.

Official Title
-----------------
A Humanitarian Device Exemption (HDE) Treatment Protocol of TheraSphere® For Treatment of Unresectable Primary or Secondary Liver Neoplasia - HDE #980006

Conditions
-----------------
Liver Cancer, Liver Neoplasms, HepatoCellular Carcinoma

Intervention / Treatment
-----------------
* Device: TheraSphere Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will be recruited from the patient population referred to the principal clinician for regional liver cancer therapy. Potential candidates are those diagnosed with primary or secondary liver neoplasia. The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers and clinical findings. Guidelines from the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) describe in detail the approach and algorithm for diagnosing Hepatocellular Carcinoma (HCC). Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 - 2 Life expectancy ≥ 3 months > 4 weeks since prior radiation, surgery or chemotherapy Able to comprehend and provide consent in accordance with institutional and federal guidelines Exclusion Criteria: Any other liver therapy planned for cancer treatment Uncorrectable flow to the gastrointestinal tract Estimated radiation doses to the lungs greater than 30 Gy in a single administration or 50 Gy in multiple administrations Significant extrahepatic disease representing imminent life-threatening outcome Pregnancy

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: TheraSphere Treatment|TheraSphere® is delivered into the liver tumor through a catheter placed into the hepatic artery. The hepatic artery provides the main blood supply to the tumor in the liver, whereas the portal vein supplies blood to normal liver parenchyma. TheraSphere® is embolized within the tumor and exerts a local beta radiation radiotherapeutic effect with relatively limited concurrent injury to surrounding normal tissue.|

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
-----------------
Humanitarian Device Exemption, Liver Disease, HDE #980006