linjc16/ctgov huggingface dataset:
Effects of Sea Buckthorn Oil on Dry Eye

Study Overview
=================
Brief Summary
-----------------
The objective is to study the effect of sea buckthorn oil on dry eye.

Detailed Description
-----------------
The objective is to study whether regular consumption of sea buckthorn berry oil can relieve the symptoms of dry eye syndrome. The study design is a parallel randomized double-blind placebo controlled trial. The participants daily consume sea buckthorn or placebo oil for 3 months. The dry eye symptoms will be monitored during the study using a validated questionnaire. In addition clinical dry eye tests are made by an ophthalmologist three time during the study. Samples will be taken for tear film lipid and cytokine analyses. Blood samples for the analyses of inflammatory markers are also obtained. The cytokine and other inflammation marker analyses are optional. The symptoms will be monitored and clinical tests made also 4 weeks after the participants have stopped consuming the study oils.

Official Title
-----------------
Effects of Sea Buckthorn Oil on Dry Eye

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Dietary Supplement: Sea buckthorn (Hippophaë rhamnoides) oil
* Dietary Supplement: Placebo comparison


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dry eye symptoms Exclusion Criteria: Severe illness Anticholinergic drugs Smoking

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SB<br>Sea buckthorn oil group | Dietary Supplement: Sea buckthorn (Hippophaë rhamnoides) oil<br>* Dosage 2 g/d, frequency twice/d, duration 3 months<br>|
| Placebo Comparator: PL<br>Placebo group | Dietary Supplement: Placebo comparison<br>* Placebo comparison, dosage 2 g/d, frequency twice/d, duration 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom severity: symptom questionnaires and clinical dry eye tests |  | 3 months intervention + 1 month after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear film lipid profile, tear cytokines, inflammation mediators in blood |  | 3 months intervention + 1 month after the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dry eye, sea buckthorn, Hippophaë
Cost Assessment of Videolaryngoscopy Compared to Direct Laryncoscopy in a Large Academic Center

Study Overview
=================
Brief Summary
-----------------
Cost, both direct and indirect, assessment of videolaryngoscopy, specifically the McGrath, compared to direct laryncoscopy in a large academic center.

Official Title
-----------------
Cost Assessment of Videolaryngoscopy Compared to Direct Laryncoscopy in a Large Academic Center

Conditions
-----------------
Economic Problems

Participation Criteria
=================
Eligibility Criteria
-----------------
Data were obtained on all endotracheal intubations where the Anesthesiology service was assigned to staff a surgical case requiring tracheal intubation during general anesthesia. Data were also obtained for tracheal intubations outside the operating room (ICUs, Trauma, patient wards) when Anesthesiology personnel were requested which did not include the Emergency Department Electronic patients' medical records spanning a two-year period (July 1, 2019 to June 30, 2021)
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 |
| --- | --- |
| Direct Laryngoscopy<br> | |
| Video Laryngoscopy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost comparison |  | 2 years |
Islet Function and Clinical Analyses of Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
To follow the patterns and natural history of Islet Transplant recipients (the ones that were involved in the Modified Edmonton Protocol) using oral glucose to check sugar levels as well as insulin and C-peptide over the course of 5 years

Official Title
-----------------
Islet Function and Clinical Analyses if Transplant Recipients (Project 2 of JDFI Washington University Center For Islet Transplantation) (Please Note That the JDRFI Funded Has Ended

Conditions
-----------------
Type One Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: OGTT (Oral Glucose Tolerance Test)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 Diabetes with hypoglycemia unawareness that received a Islet Transplant here at Washington University control subjects were matched to the transplant recipients base upon age, height, weight, & race (and could not have diabetes) Exclusion Criteria: well controlled Type 1 diabetes transplant failure unable to match potential subject to a recipient

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Islet Recipient<br>Subjects that have successfully received and maintained an Islet transplant at Washington University Center for Islet Transplantation | Other: OGTT (Oral Glucose Tolerance Test)<br>* Subjects would consume 75grams of sugar (Dextrose, 10 oz) and blood samples taken at specified time points to measure glucose, insulin and C-peptide<br>|
| Control<br>subjects that were similar in height, weight and age that did NOT have diabetes to act as the comparative group | Other: OGTT (Oral Glucose Tolerance Test)<br>* Subjects would consume 75grams of sugar (Dextrose, 10 oz) and blood samples taken at specified time points to measure glucose, insulin and C-peptide<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OGTT will be performed every 6 months for 5 years in subjects with a functioning Islet Transplant |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The OGTT reflects the function of the Islet transplant and could be used as an indication of Islet Transplant function |  | 5yrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes
CPAP in Diabetes Type 2 Patients With Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
Aim: To assess if six months of treatment with CPAP associated with conventional drug therapy, contribute to improved glycemic control in patients with type 2 diabetes and sleep apnea-hypopnea syndrome SAHS)

Detailed Description
-----------------
Main objective: To assess the effect of 6 months of CPAP treatment associated with conventional drug therapy on glycemic control in patients with type 2 diabetes and sleep apnea-hypopnea syndrome (SAHS)

Official Title
-----------------
Effect Of Nasal CPAP On Glycemic Control In Patients With Poorly Controlled Type 2 Diabetes And Sleep Apnea-Hypopnea Syndrome

Conditions
-----------------
Diabetes, Sleep Apnea

Intervention / Treatment
-----------------
* Device: CPAP nasal treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects 18 to 75 years old; diagnosis of type 2 diabetes mellitus; treatment with diet; oral antidiabetics or insulin stable in the last month; levels of HbA1c> 7.5% (if not supported clinic two controls to confirm with a difference not exceeding 0.5%); overweight or obese (BMI ≥ 25 kg/m2) Exclusion Criteria: professional drivers, risk profession or respiratory failure; excessive daytime sleepiness is very high (Epworth scale> 18); morbid obesity (BMI> 40 kg/m2); CPAP treatment

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: lifestyle and diabetes treatment<br>Counseil about lifestyle and current diabetes treatment | |
| Experimental: CPAP nasal treatment<br>Continuous positive airway pressure (CPAP) nasal during the night and current diabetes treatment. Device | Device: CPAP nasal treatment<br>* Treatment with titred CPAP nasal during the nighttime<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control | To assess the effect of 6 months of CPAP therapy and conventional treatment on glycemic control in patients with type 2 diabetes and sleep apnea-hypopnea syndrome (SAHS) | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine additional effects of CPAP on insulin resistance in patients with type 2 diabetes and SAHS. | . Determine the medium term additional effect of CPAP on insulin resistance in patients with type 2 diabetes and SAHS. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Apnea- hypopnea Syndrome, Glycemic control, Prevalence, SAHS, life quality
Study in Patients With COPD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine which dose of the investigational drug is the most safe and effective compared to the control drug.

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Drug: Formoterol Fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -History of COPD and cigarette smoking Exclusion Criteria: Clinical diagnosis of asthma. Chest X-ray that is diagnostic of a significant pulmonary disease other than COPD Disease of other major organ systems

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Formoterol Fumarate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome variable is the measure of lung function. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lung function will be examined as a secondary outcome, as well as vital signs, physical examination, adverse even reporting, etc. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, formoterol
A Study to Assess the Safety and Effectiveness of Tacrolimus Cream in the Treatment of Psoriasis

Study Overview
=================
Brief Summary
-----------------
A study to assess the safety and effectiveness of tacrolimus cream in the treatment of psoriasis.

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Tacrolimus Cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of plaque psoriasis Exclusion Criteria: Skin disorder other than plaque psoriasis in the areas to be treated. Disease on only elbows, knees, and scalp

Ages Eligible for Study
-----------------
Minimum Age: 12 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

| Intervention/Treatment |
| --- |
|Drug: Tacrolimus Cream|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
-----------------
Treatment Outcome, Tacrolimus, Safety, Psoriasis
Effects of Mineral Water Consumption on Serum Lipid Parameters

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the effect of a specific mineral water on serum lipid concentrations in healthy subjects.

Official Title
-----------------
Effects of Mineral Water Consumption on Serum Lipid Parameters: a Double-Blind, Randomized Controlled Trial

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

Intervention / Treatment
-----------------
* Dietary Supplement: Mineral water (Hita, Oita, Japan)
* Dietary Supplement: Mineral water (Aso-gun, Kumamoto, Japan)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy as based on medical history and physical examination Fasting serum LDL cholesterol > 100 and/or fasting serum triglyceride > 100 Willing to drink mineral water for 12 weeks Willing not to serve as blood donor during the study Informed consent signed Exclusion Criteria: Female subjects who are pregnant or nursing a child Participation in any clinical trial up to 90 days before Day 01 of this study Renal or hepatic dysfunction Heart disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mineral water 1<br> | Dietary Supplement: Mineral water (Hita, Oita, Japan)<br> <br> |
| Experimental: Mineral water 2<br> | Dietary Supplement: Mineral water (Aso-gun, Kumamoto, Japan)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting total cholesterol, LDL cholesterol, and triglyceride levels |  | Every 4 weeks (Overall 20 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting serum glucose and HbA1c levels |  | Every 4 weeks (Overall 20 weeks) | 
| Serum uric acid level |  | Every 4 weeks (Overall 20 weeks) | 
| Serum adiponectin and leptin levels |  | Week 0, Week 12 | 
| Urinary oxidative stress marker |  | Week 0, Week 12 |
Treatment of CFS & Fibromyalgia With Recovery Factors

Study Overview
=================
Brief Summary
-----------------
The study will explore if Recovery Factors improve symptoms in fibromyalgia and chronic fatigue syndrome

Detailed Description
-----------------
Subjects will receive four tablets twice a day (three times a day for five day loading dose), taking the treatment for 5 - 6 weeks. Subjects will receive four tablets twice a day (three times a day for five day loading dose), taking the treatment for 5 - 6 weeks. The treatment is a unique nutritional peptide mix derived from porcine serum

Official Title
-----------------
Treatment of CFS & Fibromyalgia With Recovery Factors

Conditions
-----------------
Fibromyalgia, Chronic Fatigue Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: Recovery Factors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet ACR 2010 amended Fibromyalgia criteria or CDC CFS Criteria Overall well being score of 5 of less (on 0-10 VAS) Exclusion Criteria: Pregnant Clotting disorders -

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
Interventional Model Description: Open pilot study to assess efficacy and antibody effects
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Assessing clinical efficacy<br>Subjects will receive four tablets twice a day (three times a day for five day loading dose), taking the treatment for 5 - 6 weeks. The treatment is a unique nutritional peptide mix derived from porcine serum. Pre-and post FIQ-R and VA symptom score will be assessed as well as overall well-being. In a subgroup, pre-and post antibody levels will also be checked. Phase 1 will be a group of 60 subjects | Dietary Supplement: Recovery Factors<br>* Porcine serum amino acid/peptide<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS | Composite VAS (1-10) for Fatigue, Pain, Cognition, Sleep and overall well-being | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antibody titres | Total IgG and IgG 1-4 subsets | 10 weeks | 
| FIQ-R | Fibromyalgia severity scale | 6 weeks |
Intestinal Failure in Necrotising Enterocolitis

Study Overview
=================
Brief Summary
-----------------
Necrotizing enterocolitis (NEC) is a severe gastrointestinal disorder with high morbidity and mortality (20-40%), affecting predominantly premature neonates. NEC continues to present a diagnostic challenge to clinicians. The initial clinical manifestations of NEC are non-specific and indistinguishable from other gastrointestinal disorders and sepsis. The first goal of this study is to find and evaluate tests to diagnose NEC at an early stage. For the development of new diagnostic markers, the investigators require knowledge of pathophysiological processes that underlie NEC, which still remain unclear. Therefore, the second goal of this study is to elucidate the etiology of NEC. Furthermore, understanding of the pathophysiology of NEC can offer the possibility to develop new therapeutical treatments.

Official Title
-----------------
Intestinal Failure in Necrotising Enterocolitis

Conditions
-----------------
Necrotizing Enterocolitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonates with abdominal signs suspected of NEC All neonates admitted to the NICU of the Maastricht University Medical Center between July 2007 and July 2008 Exclusion Criteria: No written informed consent of both parents
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NEC suspected - Final diagnosis NEC<br> | |
| NEC suspected - Final diagnosis no NEC<br> | |
| Controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary I-FABP |  | Within the first 30 days (plus or minus 3 days) after clinical suspicion of NEC |
Retrospective Analysis of Treatment Outcomes in Patients With Bacterial Overgrowth Syndrome Diagnosed by D-Xylose Breath Testing

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to compare the efficacy of prokinetics versus antibiotics versus a combination of antibiotics plus prokinetics in the eradication of Small-Intestinal Bacterial Over-Growth Syndrome (SIBO) in those with and without a positive D-xylose Breath Test. Hypothesis: Patients with SIBO treated with a combination of prokinetics and in particular octreotide and antibiotics will have reduced recurrence rates of SIBO than either therapy given alone.

Detailed Description
-----------------
We want to determine whether treatment with prokinetics such as Octreotide, Azithromycin, Erythromycin or Tegaserod alone, versus antibiotics alone, or combination of antibiotics plus prokinetics results in symptomatic improvement in patients with SIBO (defined by a positive D xylose Breath test).

Official Title
-----------------
Retrospective Analysis of Treatment Outcomes in Patients With Bacterial Overgrowth Syndrome Diagnosed by D-Xylose Breath Testing

Conditions
-----------------
Small Intestinal Bacterial Overgrowth Syndrome (SIBO), Small Bowel Bacterial Overgrowth Syndrome (SBBOS)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have had 14 C-D-Xylose Breath test performed in GI Motility Laboratory at the University of Florida Exclusion Criteria: Those who cannot tolerate 14 C-D-Xylose Breath test for any reason
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 |
| --- | --- | --- |
| clinical response to treatments as measured by changes in patients' GI symptoms, weight and lab data | Overall clinical response to each treatment (antibiotic, pro-kinetic, or both) and any symptoms reported in up to 8 separate clinical visits in the follow-up of these patients during the above mentioned time period will be analyzed and reviewed retrospectively using the patients' charts. | A retrospective chart review of up to 8 clinical visits between January 2000 and September 2010 will be conducted on all patients who have had a D-Xylose Breath Test at the Shands Motility Laboratory at the University of Florida during this time period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Small intestinal bacterial overgrowth syndrome (SIBO), bacterial overgrowth syndrome, Small Bowel Bacterial Overgrowth Syndrome (SBBOS), 14-Co2 D-Xylose Breath Testing, Antibiotics, Prokinteics, Prokinetic Agents