linjc16/ctgov huggingface dataset:
Distribution of Helicobacter Pylori After Gastrectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to know the distribution of Helicobacter pylori in stomach before subtotal gastrectomy and after subtotal gastrectomy.

Detailed Description
-----------------
Endoscopy and biopsy will be performed to investigate the distribution of Helicobacter pylori before and after subtotal gastrectomy.

Official Title
-----------------
Distribution of Helicobacter Pylori in Remnant Stomach After Subtotal Gastrectomy

Conditions
-----------------
Helicobacter Pylori Infections

Intervention / Treatment
-----------------
* Diagnostic Test: Endoscopic biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are indicated to subtotal gastrectomy due to gastric neoplasm Aged between 19 to 75 years Informed consent Exclusion Criteria: Previous history of Helicobacter pylori eradication Previous history of proton pump inhibitor use within 6 months

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 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 |
| --- | --- |
| Helicobacter pylori(HP) positive<br>Participants who are diagnosed with gastric cancer and Helicobacter Pylori infection will be treated with subtotal gastrectomy. | Diagnostic Test: Endoscopic biopsy<br>* Pre-operation (initial diagnosis) Assessment atrophy and metaplasia in stomach, Check Helicobacter pylori Post-subtotal gastrectomy (After 6 months) Assess the distribution of helicobacter pylori after subtotal gastrectomy. Post-subtotal gastrectomy (After 12 months) Assess the distribution of helicobacter pylori after subtotal gastrectomy. Post-subtotal gastrectomy (After 24 months) Assess the distribution of helicobacter pylori after subtotal gastrectomy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of Helicobacter Pylori After Gastrectomy | Analysis the change of Helicobacter pylori according to the subtotal gastrectomy | Change in the distribution of Helicobacter Pylori at 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of atrophy after gastrectomy | Analysis the change of atrophic status according to the subtotal gastrectomy | Change in the atrophic status at 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stomach Neoplasms, Helicobacter pylori, Subtotal gastrectomy
Effects of Betaserc on Vestibular Compensation in Patients Suffering From Disabling Meniere's Disease and Having Undergone Vestibular Neurotomy

Study Overview
=================
Brief Summary
-----------------
This study is to compare the effects of Betaserc 24mg and placebo on compensation of postural and locomotor deficits (static and dynamic posturography) after vestibular neurotomy in patients suffering from disabling Menière's disease.

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Randomized, Clinical Study of the Effects of Betaserc® 24 mg (1 Tablet b.i.d Over 3 Months) on Vestibular Compensation Following Vestibular Neurotomy in Patients With Disabling Menière's Disease

Conditions
-----------------
Meniere's Disease

Intervention / Treatment
-----------------
* Drug: Betahistine 24 mg bid (Betaserc)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have undergone vestibular neurotomy for the treatment of disabling Menière's disease and who have confirmed vestibular areflexia Exclusion Criteria: Other peripheral vestibular disease than Menière's disease Central vestibular disease Neurological disease Contraindication to betahistine Pregnant or lactating women

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Betahistine 24 mg bid (Betaserc)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients who have undergone vestibular neurotomy for the treatment of disabling Menière's disease and who have confirmed vestibular areflexia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other peripheral vestibular disease than Menière's disease;Central vestibular disease; Neurological disease; Contraindication to betahistine; Pregnant or lactating women |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Meniere's disease, Vestibular neurotomy
Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma

Study Overview
=================
Brief Summary
-----------------
Our research of the biology of upper gastrointestinal cancers involves the study of tissue samples and cells from biopsies of persons with gastric or esophageal cancer or blood samples from upper gastrointestinal cancer patients and persons at high inherited risk for these cancers. We hope to learn the role genes and proteins play in the development of gastric and esophageal cancer.

Official Title
-----------------
Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma

Conditions
-----------------
Stomach Cancer, Gastro-Esophageal(GE) Junction Cancer, Gastric (Stomach) Cancer, Esophageal Cancer, Gastrointestinal Stromal Tumor (GIST)

Intervention / Treatment
-----------------
* Procedure: Blood draw
* Procedure: Tissue tumor biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 Diagnosed with gastric or esophageal cancer OR at an increased hereditary risk for upper GI cancer Exclusion Criteria: Under 18 No family or personal history of gastric or esophageal cancer

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

| Intervention/Treatment |
| --- |
|Procedure: Blood draw|nan|
|Procedure: Tissue tumor biopsy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| p53 activity by routine pathologic analysis |  | time of collection | 
| NER activity by routine pathologic analysis |  | time of collection |
Effect of Vitamin B on Plasma Neurofilament Light Protein (NFL) in HIV-infected Individuals With Increased Plasma Homocysteine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate if B vitamin substitution have effect on NFL (neurofilament light protein) plasma levels and neurocognitive performance in HIV-infected individuals with increased plasma homocysteine

Official Title
-----------------
Effect of Vitamin B Substitution on Plasma NFL and Neurocognitive Performance in HIV-infected Individuals With Increased Plasma Homocysteine

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Drug: Cyanocobalamin
* Drug: Folate
* Drug: Pyridoxine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The ability to understand and give informed consent to participate. HIV-1 infected with stable ART > 12 months Plasma HIV-RNA < 50 copies/ml Plasma homocysteine ≥ 12 μmol/L (subjects with < 12 μmol/L will be included in the analysis of secondary endpoint 3 (see 5.4). Male or female, age 18 or older. Exclusion Criteria: Treatment with trimethoprim-sulfamethoxazole or methotrexate Ongoing B6, B12 or folate substitution Antiepileptic treatment Small bowel or ventricular resection Disturbed absorption in small bowel (Mb Crohn, untreated coeliac disease) Ongoing neurological disease or severe psychiatric disease Any malignant tumor in the history. Severe ongoing infection or opportunistic infection AUDIT > 7 for men and > 5 for women MADRS > 20 Significant B12 or folate deficiency that indicate substitution (all subjects will be offered adequate substitution, they will be included in the analysis of secondary endpoint 3 (see 5.4)). Pregnancy at screening visit, or planning pregnancy during study period is an exclusion criteria. (Not due to toxicity of Triobe, but to elevated risk of being prescribed B-vitamins outside of trial. If study object gets pregnant during study, she can continue the study but must be excluded if she starts treatment with other B-vitamin treatment than Triobe.)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triobe<br>Cyanocobalamin 0,5 mg. Daily for 24 months. Folate 0,8 mg. Daily for 24 months. Pyridoxine 3,0 mg. Daily for 24 months. | Drug: Cyanocobalamin<br> <br> Drug: Folate<br> <br> Drug: Pyridoxine<br> <br> |
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Declining NFL or decreased rate of increase of NFL |  | One year |
Treatment of Bacterial Vaginosis in Early Pregnancy in Skaraborg and the Effect on Spontaneous Preterm Delivery

Study Overview
=================
Brief Summary
-----------------
Bacterial vaginosis (BV) is a known risk factor for preterm delivery. This study was conducted in an attempt to investigate if treatment of bacterial vaginosis in early pregnancy could reduce the risk for preterm delivery. Women were screened for bacterial vaginosis during the first visits at the maternal health care unit with a vaginal sample that were taken by the midwife or by herself. After the vaginal samples was air dried it was sent to the gynaecological department and was investigated using Hay/Ison classification. Eligible women were those who had lived in Skaraborg and delivered at Skaraborg hospital.

Detailed Description
-----------------
The study has started 2007 and will continue until 2014. Pregnant women that will come to the maternal health care units in gestational week 8-11 will be offered to be screened for bacterial vaginosis. A vaginal sample will be taken by the midwife or by the women herself. The vaginal sample is air-dried and sent to the gynecological. There it is investigated using Hay/Ison classification for the diagnosis of bacterial vaginosis. Women with bacterial vaginosis will be offered treatment with topical clindamycin treatment for 7 days if the women has passed the 12th gestational week. A control sample for the test of cure will be done after 10 week. If not cured of BV she will be offered a new treatment. All women will be followed until delivery.

Official Title
-----------------
Treatment of Bacterial Vaginosis in Early Pregnancy in Skaraborg County in Sweden and the Effect on Spontaneous Preterm Delivery

Conditions
-----------------
Bacterial Vaginosis

Intervention / Treatment
-----------------
* Drug: Clindamycin-2-phosphate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women screened for bacterial vaginosis in early pregnancy Exclusion Criteria: women not delivered at Skaraborg hospital.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 52 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| treatment of bacterial vaginosis<br>women with bacterial vaginosis will be offered treatment with clindamycin-2-phosphate | Drug: Clindamycin-2-phosphate<br>* how many women will deliver before the 37th week of gestation<br>* Other names: Dalacin vaginal cream;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preterm delivery |  | before 37th week of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cure of bacterial vaginosis |  | after 10 weeks |
Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes

Study Overview
=================
Brief Summary
-----------------
This study will assess whether dietary fiber supplements can reduce the production of chemicals which are produced by colon bacteria and normally excreted from the body by the kidney, but build up in the body in patients on hemodialysis.

Detailed Description
-----------------
The study procedures will consist of: taking a dietary supplement containing either fiber or starch (starch serves as a control for fiber) for six weeks. The fiber dose initially employed will be 30 g/day of high amylose corn and the control starch dose employed will be 30 g/day of waxy corn starch. Supplements which come in dry powder form will be mixed in liquid or food for consumption. filling out a food record and a quality of life questionnaire keeping a diary of any gi symptoms collecting samples of blood, spent dialysate, urine(if the patient still makes urine) and stool.

Official Title
-----------------
Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes

Conditions
-----------------
Kidney Failure, Chronic

Intervention / Treatment
-----------------
* Dietary Supplement: Fiber
* Dietary Supplement: Corn starch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable dialysis patients able to provide consent. Exclusion Criteria:-- known g.i. disease use of antibiotics for the last two month or expected antibiotic use recent hospitalization or other event resulting in instability of food intake

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Corn Starch<br>Corn starch will serve as the control arm. | Dietary Supplement: Corn starch<br>* Corn starch to be consumed daily for 6 weeks. This will serve as the control/placebo arm.<br>|
| Experimental: Fiber<br>Fiber will serve as the intervention. | Dietary Supplement: Fiber<br>* Dietary fiber supplements to be consumed daily for 6 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma level of p-cresol sulfate |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caloric intake |  | 8 weeks |
Effect of Anti CD20 in Pemphigus Desease

Study Overview
=================
Brief Summary
-----------------
to treat in an open non comparative clinical study patients presenting pemphigus with corticodependance, corticoresistance and contre-indication to systemic steroids.

Official Title
-----------------
Traitment of Patients Presenting Pemphigus With Anti CD20 (Mabthera).

Conditions
-----------------
Pemphigus

Intervention / Treatment
-----------------
* Drug: Mabthera


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age>18 pemphigus corticoresistant pemphigus cortico dependant contre-indications : systémic steroids Exclusion Criteria: age < 18 cardiopathie pregnant woman absence contraception no consentment

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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mabthera|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary end-point was the rate of CR three months after the last infusion of Rituximab |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secondary end-points were : |  |  | 
| rate of CR during the study period |  |  | 
| time from the start of Rituximab to CR |  |  | 
| number and length of time to relapses |  |  | 
| treatment tolerance |  |  |
A Study of Safety and Efficacy Comparing ABT-874 Versus Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to compare the efficacy of ABT-874 versus Methotrexate in subjects with moderate to severe plaque psoriasis.

Detailed Description
-----------------
This study is only being conducted in the EU and Canada

Official Title
-----------------
A Phase 3, Multicenter, Randomized, Double-blind Study Comparing the Safety Efficacy of ABT-874 to Methotrexate in Subjects With Moderate to Severe Chronic Plaque Psoriasis

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

Intervention / Treatment
-----------------
* Drug: ABT-874
* Drug: Methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Psoriasis for 6 MO.. BSA 10%, PASI 12 or above, PGA 3 or above Exclusion Criteria: Previous exposure to anti-IL 12

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>ABT-874 | Drug: ABT-874<br>* 200 mg at week 0 and 4 and 100mg at week 8 and every 4 weeks there after administered as aSQ injection<br>|
| Active Comparator: B<br>Methotrexate | Drug: Methotrexate<br>* 5.0 to 25 mg weekly<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 24 |  | Week 24 | 
| The proportion of subjects who achieve a PGA score of 0 or 1 at Week 24 |  | Week 24 | 
| Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 52 |  | Week 52 | 
| The proportion of subjects who achieve a PGA score of 0 or 1 at Week 52 |  | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 24 |  | Week 24 | 
| Changes from Baseline in the DLQI total score at Week 24 |  | Week 24 | 
| Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 52 |  | Week 52 | 
| Changes from Baseline in the DLQI total score at Week 52 |  | Week 52 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis
Breast MRI in Evaluation of Pathologic Response in Patients With Breast Cancer With Neoadjuvent Chemotherapy

Study Overview
=================
Brief Summary
-----------------
evaluation of pathological response in breast mass by use of breast MRI in patients receiving neoadjuvent chemotherapy via comparison with pathological results

Detailed Description
-----------------
evaluation of pathological response in locally advanced breast masses by use of breast MRI in patients receiving neoadjuvent chemotherapy via comparison with pathological results

Official Title
-----------------
Added Value of Breast MRI in Evaluation of Pathologic Response in Patients With Locally Advanced Breast Cancer Who Undergo Neoadjuvent Chemotherapy

Conditions
-----------------
Role of MRI in Evaluation of Breast Cancer

Intervention / Treatment
-----------------
* Device: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all women referred to the radiology department for breast MRI examination either for screening, evaluation of suspicious lesions onsono-mammography \ Patients with locally advanced breast cancer Patients with early stage breast cancer and chemo-responsive tumour markers (i.e. triple negative, Her2+), who will benefit from downsizing for breast conserving surgery (BCS) Absolute or Relative contraindications to surgery (advanced age/multiple medical comorbidities) in the setting of estrogen receptor positive tumours (for consideration of neoadjuvant endocrine therapy)3 Patients must be elder than 18 years old. patients with accepted renal function Exclusion Criteria: Patients with metastatic breast cancer. Patient with breast mass more than 5 cm . Patients with fungating breast mass . Patients with stage IV [tumor spread to chest wall and to skin ]. pregnant women especially in 1th trimester. Patient with presence of any paramagnetic substance as pacemakers. severely ill patients . patients with claustrophobia. arrhythmic patients

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: MRI|use of MRI modality of imaging in evaluation of pathologic response in patients with breast cancer|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of MRI findings with pathologic results | added value of breast MRI in evaluation of pathologic response in patients with locally advanced breast cancer who undergo neoadjvent chemotherapy | baseline |