linjc16/ctgov huggingface dataset:
Effects of Sea Buckthorn Oil on Mucous Membranes

Study Overview
=================
Brief Summary
-----------------
Aim of this study is to investigate the effects of intake of sea buckthorn oil on mucous membranes

Official Title
-----------------
Effects of Sea Buckthorn Oil on Mucous Membranes

Conditions
-----------------
Mucous Membranes

Intervention / Treatment
-----------------
* Dietary Supplement: Sea buckthorn oil
* Dietary Supplement: Placebo oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women experiencing vaginal dryness 55-75 years of age at least 12 months from menstruation Exclusion Criteria: use of estrogen replacement therapy

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sea buckthorn oil<br>3 g (6 capsules)/day for three months | Dietary Supplement: Sea buckthorn oil<br> <br> |
| Placebo Comparator: Placebo oil<br>3 g (6 capsules)/day for three months | Dietary Supplement: Placebo oil<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in dryness related symptoms of genital mucous membranes | Interview for symptom score at baseline and study visits and a daily symptom logbook during the intervention | Interviews at baseline, at 2 months, at 3 moths (end of intervention), and daily during the study (symptom logbooks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in vaginal pH |  | At baseline, at 3 months (end of intervention) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sea buckthorn, mucous membrane, dryness, metabolic syndrome, vaginal atrophy
The North American Pancreatitis Study

Study Overview
=================
Brief Summary
-----------------
This study will investigate several genes and other factors measured in the blood that may cause recurrent acute pancreatitis and chronic pancreatitis. No treatment is offered as part of this study. Subjects have one single visit to provide a blood sample for genetic testing and to answer a questionnaire. Subjects are not given results of genetic testing. The study is currently enrolling African American subjects and controls only.

Detailed Description
-----------------
This study seeks to enroll African American people with and without pancreatitis. There is only one study visit to obtain consent, a blood sample and complete a questionnaire. Subjects must be patients of a participating center; controls must present to a participating center for enrollment.

Official Title
-----------------
The North American Pancreatitis Study

Conditions
-----------------
Pancreatitis

Intervention / Treatment
-----------------
* Genetic: blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: African American pancreatitis patients who are at least 14 years of age with a diagnosis of acute or chronic pancreatitis controls who do not have pancreatitis and must be at least 18 years of age Exclusion Criteria: unable or unwilling to sign informed consent

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 100 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 |
| --- | --- |
| African Americans with pancreatitis<br>pancreatitis | Genetic: blood sampling<br>* blood samples obtained to extract biomarkers and dna for analysis, questionnaires<br>|
| African Americans without Pancreatitis controls<br>people without pancreatitis | Genetic: blood sampling<br>* blood samples obtained to extract biomarkers and dna for analysis, questionnaires<br>|

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
-----------------
African Americans, pancreatitis, controls
Decidual Stromal Cells to Treat Graft-vs-Host Disease After Stem Cell Transplant for Myelodysplastic Syndrome/Myeloproliferative Neoplasm

Study Overview
=================
Brief Summary
-----------------
This is a single participant study of decidual stromal cells (DSC) for the treatment of steroid refractory graft-versus-host disease (GVHD) in a patient with myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN).

Official Title
-----------------
Decidual Stromal Cells (DSC) in Treatment of Steroid-Refractory Graft-vs-host Disease in a Recipient of Matched Related Donor Allogeneic Hematopoietic Cell Transplant for Myelodysplastic Syndrome/Myeloproliferative Neoplasm

Conditions
-----------------
Myelodysplastic/Myeloproliferative Neoplasm, Steroid Refractory GVHD, Allogeneic Hematopoietic Cell Transplant

Intervention / Treatment
-----------------
* Biological: Decidual stromal cells (DSC)


Participation Criteria
=================
Eligibility Criteria
-----------------
A single participant with myelodysplastic syndrome/myeloproliferative neoplasm located at Princess Margaret Cancer Centre who experienced steroid-refractory graft-vs-host disease after receiving an allogeneic hematopoietic cell transplant and have no standard treatment options available.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with MDS/MPN<br>DSCs will be given 1 × 10^6 cells per kilogram of participant's body weight intravenously, administered once per week up to a maximum of six weeks depending on the clinical response. | Biological: Decidual stromal cells (DSC)<br>* DSCs are isolated from donated human placenta and have been shown to have anti-inflammatory effects.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eastern Cooperative Oncology Group Performance Status Score |  | 6 weeks | 
| Karnofsky Performance Score |  | 6 weeks | 
| Graft-Versus-Host Disease Severity | By grade | 6 weeks | 
| Aspartate Transaminase levels |  | 6 weeks | 
| Alanine aminotransferase levels |  | 6 weeks | 
| Alkaline phosphatase levels |  | 6 weeks | 
| Bilirubin levels |  | 6 weeks | 
| C-reactive protein levels |  | 6 weeks |
Olfaction Disorders in Patients Included in The Trauma Brain Injury (TBI) Database at Trondheim University Hospital

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to see whether patients with chronic smell impairment after brain injury benefit from a treatment that consists of corticosteroids, and then olfactory training in 3 months.

Official Title
-----------------
Olfaction Disorders in Patients Included in The Trauma Brain Injury (TBI) Database at Trondheim University Hospital: Prevalence and Treatment

Conditions
-----------------
Brain Injuries, Olfaction Disorders

Intervention / Treatment
-----------------
* Drug: corticosteroids
* Behavioral: olfactory stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Registered in the TBI Database 18-65 years of age per 01.10. 2012 Olfaction score by Sniffin Sticks Threshold-Discrimination-Identification (TDI) < 30 confirming dysosmia Exclusion Criteria: Unable to express senses. Unable to follow treatment and protocol pregnancy diabetes tendency to infections hypertonia dyspepsia interfering medication (hormonal treatment, NSAIDS, antidiabetics, barbiturates, fenitoin, carbamazepin, rifampicin, cyclophosphamides)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olfactory disorder after brain trauma<br>Recruited from 250 patients with moderate to severe traumatic brain injury in the Hodeskadeprosjektet (TBI) cohort. Treatment with (first) corticosteroids and (second) olfactory stimulation. | Drug: corticosteroids<br> <br> Behavioral: olfactory stimulation<br>* stimulation with odorants by sniffing 4 different odorants for a total of 5 minutes twice a day during 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients who have improved olfaction perception (by at least 5 points on the Threshold-Discrimination-Identification (TDI) score | TDI score measured by Sniffin Sticks | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Olfactory perception, Adrenal cortex hormones, Steroids, Education
A Study of Avastin With Chemotherapy for Treatment of Metastatic or Advanced and Unresectable Colorectal Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
This is an observational study designed to follow patients with metastatic or locally advanced and unresectable colorectal cancer who are receiving Avastin in combination with chemotherapy and whose cancer has been either previously untreated or treated <=4 months prior to enrollment.

Official Title
-----------------
An Observational Study of Avastin (Bevacizumab) in Combination With Chemotherapy for Treatment of Metastatic or Locally Advanced and Unresectable Colorectal Adenocarcinoma

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed Consent and Authorization document Metastatic, or locally advanced and unresectable, adenocarcinoma of the colon or rectum Receiving Avastin as a component of first-line chemotherapy First-line chemotherapy plus Avastin initiated <=4 months prior to enrollment in the study Exclusion Criteria: Patients who have contraindications for treatment with Avastin (see the Avastin Package Insert) or who would incur excessive risks with Avastin treatment are ineligible for this study.
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 |
| --- | --- | --- |
Efficacy and Safety Trial of ALK-depot SQ Mites in Subjects With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
This trial is performed to assess the efficacy and safety of ALK-depot SQ mites for treatment of atopic dermatitis

Official Title
-----------------
Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Study to Demonstrate the Efficacy of a 12-month Subcutaneous Specific Immunotherapy With ALK-depot SQ Milbenmischung in Patients With Atopic Dermatitis and Proven IgE-mediated Sensitization to House Dust Mites

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Biological: subcutaneous immunotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive specific IgE to house dust mites Atopic dermatitis according to Hanifin/Rajka Chronic course of Atopic dermatitis SCORAD larger than 25 points Exclusion Criteria: Erythrodermia Syst.treatment with gcs or immunosuppressive agents in the prev.4 weeks History of specific immunotherapy with mites UV radiation Group 4 topical corticosteroids (European classification)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Active Comparator: Subcutaneous immunotherapy<br>Subcutaneous injections with ALK-depot SQ mites to 100,000 SQ-U | Biological: subcutaneous immunotherapy<br>* Updosing by 16 injections to 100,000 SQ-U<br>* Other names: ALK-depot SQ mites;|
| Placebo Comparator: Subcutaneous injections<br>placebo injections | Biological: subcutaneous immunotherapy<br>* Updosing by 16 injections to 100,000 SQ-U<br>* Other names: ALK-depot SQ mites;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in SCORAD and topical medication consumption | Sccore of atopic dermatitis (SCORAD) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in SCORAD intensity score, EASI score and change in topical medication consumption | Eczema Area Severity Index (EASI) | 1 year |
Using of Acellular Dermal Matrix in Cleft Palatal Fistula and Compare With Use of Conchal Cartolage

Study Overview
=================
Brief Summary
-----------------
The fact that still exist is which method for repairing of secondary cleft palatal fistula is the best. This study will have shown whether using of Acellular dermal Matrix decreased the fistula formation versus using Conchal Cartilage during secondary fistula. Among studies that published, they have not consensus for using acellular dermal matrix. Most of the questions are about cost effectiveness, time that surgery and rehabilitation need and patient risk ( risk of transmission disease from other human tissue )

Detailed Description
-----------------
Observational study composed of a prospective cohort group receiving ADM compared to a retrospective historical cohort group with Conchal Cartilage. Primary objectives: The primary objective of this study is to determine whether ADM would lower the incidence of palatal fistula in patients undergoing secondary cleft palate fistula repair. Secondary objectives: hypo nasality speech after surgery Improvement Speech Score

Official Title
-----------------
Using of Acellular Dermal Matrix in Cleft Palatal Fistula and Compare With Use of Conchal Cartolage

Conditions
-----------------
Cleft Palate

Intervention / Treatment
-----------------
* Procedure: repairing fistula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed as having cleft palate fistula, with ADM will be included in this study. Exclusion Criteria: Selection will be based on the patient's willingness to allow to participate in the study. Patients with diagnosed craniofacial syndromes will be excluded from the study. Children with known wound healing defects, will be excluded from the study.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acellular Dermal Matrix<br> | Procedure: repairing fistula<br>* A tailored piece of Acellular Dermal Matrix or Conchal Cartilage will be placed between the oral and nasal layers for repair of a Cleft Palate.<br>|
| Conchal Cartilage<br> | Procedure: repairing fistula<br>* A tailored piece of Acellular Dermal Matrix or Conchal Cartilage will be placed between the oral and nasal layers for repair of a Cleft Palate.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fistula formation |  | Within 2 year of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cleft palate
Development and Validation of a Disability Severity Index for CMT

Study Overview
=================
Brief Summary
-----------------
It is necessary for outcome measures to accurately reflect the state of health of a person in order for clinical trials to show benefit. The most commonly used outcome measure for Charcot Marie Tooth Disease (CMT) is the CMT Neuropathy Score, which uses cutoffs of points designated as mild (0-10 points), moderate (11-20) or severe (21-36). These terms are arbitrary. This study is looking to base mild, moderate, and severe on what both people affected with CMT and those who provide for people with CMT consider appropriate.

Official Title
-----------------
Development and Validation of a Disability Severity Index for Charcot Marie Tooth Disease

Conditions
-----------------
Charcot Marie Tooth Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with CMT ages 8-100, health care professionals who take care of patients with CMT. Eligible patients will be patients that have joined the INC RDCRN Contact Registry. These will be patients or guardians with known or probable inherited neuropathies. Eligible health care professionals who participate in the care of patients with inherited neuropathies (physicians, genetic counselors, physical and occupational therapists etc.) attending the 4th International CMT Consortium to be held in Potomac Maryland June 29-July 1, 2011. Exclusion Criteria: Does not read or speak English.

Ages Eligible for Study
-----------------
Minimum Age: 8 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 |
| --- | --- |
| Health Care Provider<br>A person working within the field of CMT. | |
| Patient with CMT<br>Any person of any age self-identifying as having CMT and belonging to the Inherited Neuropathies Consortium Contact Registry hosted by the Rare Disease Clinical Research Network. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare Patient and Healthcare Provider impressions of what constitutes mild, moderate and severe impairment in CMT |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Develop a Disability Severity Index including items with high patient-physician concordance |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CMT
Does a Single Shot Femoral Nerve Block Alone Produce Appropriate Pain Relief?

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the efficacy of the analgesic effect of the preoperative femoral nerve block alone versus combined femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks in patients after TKA in the immediate postoperative period.

Detailed Description
-----------------
Bupivacaine will be used for all the nerve blocks.

Official Title
-----------------
Does a Single Shot Femoral Nerve Block Alone Produce Appropriate Pain Relief After Total Knee Arthroplasty or Should an Addition of Sciatic, Obturator and Lateral Femoral Cutaneous Nerve Blocks be Recommended?

Conditions
-----------------
Post-operative Pain

Intervention / Treatment
-----------------
* Drug: Femoral Nerve Block
* Drug: Combined nerve blocks
* Drug: Patient-controlled analgesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-III Undergoing two TKA Understanding PCA protocol Exclusion Criteria: Skin infection near injection site Allergy to local analgesics Peripheral neuropathy Coagulopathy Dementia Proven opioid dependency

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 85 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Femoral Nerve Block<br> | Drug: Femoral Nerve Block<br>* Preoperative Bupivacaine 0.5%, perineurally as single shot<br>|
| Active Comparator: Combined Nerve Blocks<br> | Drug: Combined nerve blocks<br>* Preoperative Bupivacaine 0.5%, perineurally as single shot<br>|
| Active Comparator: Patient-controlled analgesia<br> | Drug: Patient-controlled analgesia<br>* Patient controlled analgesia with morphine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of single short femoral nerve block |  | Three days |