linjc16/ctgov huggingface dataset:
Boswellia Serrata Extract in Acute Diarrhea

Study Overview
=================
Brief Summary
-----------------
Acute diarrhea is a frequent problem worldwide, mostly due to gastrointestinal infections or food poisoning. Boswellia serrata could be active in the treatment of acute diarrhea due to its an-ti-inflammatory, antispasmodic and antimicrobial activity.

Official Title
-----------------
Positive Effects of a Lecithin-based Delivery Form of Boswellia Serrata Extract in Acute Diarrhea of Adult Subjects

Conditions
-----------------
Acute Diarrhea, Boswellia Serrata

Intervention / Treatment
-----------------
* Dietary Supplement: lecithin-based delivery form of Boswellia serrata
* Combination Product: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presence of acute diarrhea of mild to moderate severity Exclusion Criteria: patients with long term diarrhea iatrogenic diarrhea symptoms of functional gut disease or severe inter-current diseases severe diarrhea and dehydration requiring hospitalization and intravenous treatment subjects with high temperature (> 38.5° C) subjects treated by other anti-diarrheal and antibiotic drugs in the last 24 hours severely malnourished subjects pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Boswellia Phytosome<br> | Dietary Supplement: lecithin-based delivery form of Boswellia serrata<br>* 250 mg for 5 days<br>|
| Placebo Comparator: Placebo<br> | Combination Product: Placebo<br>* 250 mg for 5 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stoppage of diarrhea | the occurrence of the first formed stool or a period of 12 hours without any liquid or soft stools | From baseline to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-assessed symptoms | daily number of stools within 5 days of treatment | After 5 days | 
| Self-assessed symptoms | percentage of subjects without diarrhea within 5 days of treatment | After 5 days |
Evaluation of the Effect of Root Canal Preparation by TF and M-Pro on Post-Operative Pain After Single Visit Endodontic Treatment

Study Overview
=================
Brief Summary
-----------------
A study to comparatively evaluate the post operative pain between root canal preparation by reciprocating file (TF) and full rotation file (M-Pro) in patients with single rooted teeth with acute irreversible pulpits.

Detailed Description
-----------------
Teeth with symptomatic irreversible pulpitis are selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment after using Twisted files or M-pro files. The treatment is done in single visit. The postoperative pain is then assessed using the Numerical Rating Scale 6,12, 24 and 48 hours post-instrumentation.

Official Title
-----------------
Evaluation of the Effect of Root Canal Preparation by TF and M-Pro on Post-Operative Pain After Single Visit Endodontic Treatment: A Blinded Randomized Clinical Trial Therapeutic Study.

Conditions
-----------------
Acute Pulpitis

Intervention / Treatment
-----------------
* Device: Twisted file
* Device: Mpro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in good health (American Society of Anesthesiologists Class II or higher). Patients having symptomatic irreversible pulpitis in their single rooted teeth. Age range is between 20 and 60 years. Patients who can understand numerical rating scale (NRS). Patients able to sign informed consent. Exclusion Criteria: Patients with positive percussion test. Patients having history of necrosis with or without apical pathosis. Patients have sinus tract or fistula extra oral or intraoral. Pregnant or mentally retarded patients. Teeth with grade 2 or 3 mobility.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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: Twisted file<br>Use of twisted file during cleaning and shaping of root canals | Device: Twisted file<br>* Use of twisted file during cleaning and shaping of root canals<br>|
| Active Comparator: Mpro<br>Use of Mpro file during cleaning and shaping of root canals | Device: Mpro<br>* Use of Mpro during cleaning and shaping of root canals<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain | Post-operative pain assessed after treatment using the NRS pain scale | 2 days |
MEV to Block the Posterior and Lateral Cords of the Infraclavicular Brachial Plexus

Study Overview
=================
Brief Summary
-----------------
The investigators have recently shown that LSIB in combination with a suprascapular and a cervical plexus block is a very good alternative for arthroscopic shoulder surgery. However, the investigators believe the total volume of local anesthetic for LSIB may be reduced. For shoulder surgery there is no need to block the medial cord and the investigators therefore hypothesize a significantly lower MEV95% by applying a selective lateral and posterior cord block

Detailed Description
-----------------
The MEV for a successful block in 50% of the participants will be determined by using the staircase up-and-down method introduced by Dixon and Massey. Logistic regression and probit transformation will be applied to estimate the MEV for a successful block in 95% of the participants.

Official Title
-----------------
Minimum Effective Volume (MEV95%) of Ropivacaine 7.5 mg/ml to Block the Posterior and Lateral Cords of the Infraclavicular Brachial Plexus

Conditions
-----------------
Shoulder Disease, Anesthesia

Intervention / Treatment
-----------------
* Drug: Ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: . Inclusion criteria are American Society of Anesthesiologists (ASA) physical status I-III, age between 18 and 70 years and body mass index (BMI) between 20 and 35 kg/m2. Exclusion Criteria: Exclusion criteria are pregnancy, patients with contraindications to regional anesthesia, allergy to LAs, patients taking opioids regularly due to chronic pain, use of anticoagulation drugs other than acetylsalicylic acid or dipyridamole, atrioventricular block, diabetes.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Other: Ropivacaine<br>Single arm intervention | Drug: Ropivacaine<br>* Minimum effective volume<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimum effective volume (95%) |  | 30 minutes |
Adenovirus Vaccine Pregnancy Registry

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the Adenovirus Vaccine Pregnancy Registry is to prospectively collect data concerning: Pregnant women exposed to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral, Potential confounding factors, and The outcome of these pregnancies. The secondary purpose of the Adenovirus Vaccine Pregnancy Registry is to evaluate the frequency of birth defects in prospectively enrolled pregnant women. This Registry is also designed to detect any unusual patterns of birth defects.

Official Title
-----------------
Adenovirus Vaccine Pregnancy Registry

Conditions
-----------------
Adenovirus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For women: U.S. Military service member, present or former Confirmed exposure to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral Received Adenovirus Type 4 and Type 7 Vaccine, Live, Oral while pregnant or has an estimated date of conception (DOC) within 6 weeks after receiving Adenovirus Type 4 and Type 7 Vaccine, Live, Oral Positive β-hCG test or fetal ultrasound,and Verbal and/or written informed consent obtained from the patient. For live born offspring: Infant born to a woman meeting the above inclusion criteria and enrolled in the Registry, followed through one year post delivery, and Verbal and/or written informed consent obtained from the mother of the infant. Exclusion Criteria: Patients who refuse to provide informed consent (verbal or written) to the Institutional Review Board (IRB)-approved informed consent. Females not exposed to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral within the inclusion criteria period. Patients not willing to meet Registry study conditions and requirements.

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br>This is a prospective, observational, exposure-registration and follow-up study of pregnant women exposed to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral and their live born offspring through the first year of life. The intent of the Adenovirus Vaccine Pregnancy Registry, Protocol DR-501-401, is to collect observational data on pregnancy outcomes, including birth defects, in women who were exposed to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Pregnancy Outcome by observation | Infants up to 12 months of age | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adenovirus, Adenovirus Type 4, Adenovirus Type 7, Adenovirus Type 4 and Type 7 Vaccine, Live, Oral
Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of 1 year of risedronate treatment on the prevention of bone loss after denosumab discontinuation in denosumab-treated post-menopausal osteoporosis for a year

Official Title
-----------------
A Multicenter, Open-label, Single-arm Clinical Trial to Evaluate the Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women

Conditions
-----------------
Postmenopausal Osteoporosis

Intervention / Treatment
-----------------
* Drug: Risedronate Sodium 35 MG [Actonel]
* Drug: Calcium Vitamin D combination


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Postmenopausal women Patients diagnosed with postmenopausal osteoporosis and administered denosumab for 1 year Main Exclusion Criteria: Any contraindication to risedronate Those evaluated as inappropriate at the discretion of the investigator

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Actonel®<br>Risedronate Sodium 35mg | Drug: Risedronate Sodium 35 MG [Actonel]<br>* Risendronate Sodium Tab. 35mg, orally, once weekly<br>Drug: Calcium Vitamin D combination<br>* orally, once daily for concomitant drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline in lumbar spine bone mineral density (LS BMD) at 1 year (%) | Percent change from baseline in lumbar spine bone mineral density (LS BMD) at 1 year (%) | 1 year |
Revisional Versus Primary Roux-en-Y Gastric Bypass: a Case Matched Analysis

Study Overview
=================
Brief Summary
-----------------
This study compared revisional malabsorptive laparoscopic very very long limb gastric bypass (VVLL RYGB) with primary VVLL RYGB and tested the hypothesis that one staged revisional laparoscopic VVLL RYGB is a safe and effective procedure after failed restrictive gastric banding.

Official Title
-----------------
Revisional Versus Primary Roux-en-Y Gastric Bypass: a Case Matched Analysis

Conditions
-----------------
Effect of Revisional Surgery for Failed Gastric Banding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary Gastric Bypass according to SMOB (Swiss group for the study of morbid obesity) Guidelines Revisional Gastric Bypass after failed Gastric Banding Exclusion Criteria: According to SMOB Criteria

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Morbidly obese patients<br>48 morbidly obese patients with revisional gastric bypass | |
| 48 morbidly obese patients<br>with primary gastric bypass | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate |  | early (30 days) and late (> 30 days) |
Effectiveness of Rifaximin on Preventing Postoperative Recurrence in Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
Some studies have shown that rifaximin is effective in the management of Crohn's Disease. Meanwhile, its adverse effect is tolerable. But no study has been conducted to assess its effect on preventing postoperative recurrence. Thus, we conduct a randomised controlled study to assess the effect of rifaximin on preventing postoperative endoscopic recurrence in Crohn's disease. The primary endpoint is the rate of endoscopic recurrence at 6 months.

Official Title
-----------------
Effectiveness of Rifaximin on Preventing Postoperative Endoscopic Recurrence in Crohn's Disease Patients Without Risk Factor for Recurrence: A Multicenter Randomized Controlled Trial

Conditions
-----------------
Crohn Disease

Intervention / Treatment
-----------------
* Drug: Rifaximin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients with Crohn's disease undergoing intestinal resection of all macroscopic diseased bowel, with an endoscopically accessible ileocolic anastomosis; Enrolled patients without risk factor for the development of postoperative recurrence including penetrating disease behaviour, prior bowel resection, and active smoking. Exclusion Criteria: Severe comorbidities; With a stoma; With malignancy; Pregnancy; With contraindication of using rifaximin.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rifaximin<br>Prescribed Rifaximin (600mg, twice daily) for 3 months after surgery | Drug: Rifaximin<br>* Antibiotics<br>|
| No Intervention: Blank control<br>No intervention after surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference of incidence of endoscopic recurrence | Endoscopic recurrence was defined by a score ≥i2 according to endoscopic recurrence score developed by Rutgeerts et al. | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effect | Adverse effect of Rifaximin | 6 months after surgery |
Comparison of Insulin Glargine Versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in Combination With Metformin in Subjects With Type 2 Diabetes.

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia. The aim of the trial is to compare the glycaemic control of Insulin glargine versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in combination with metformin in subjects with Type 2 Diabetes.

Official Title
-----------------
Safety and Efficacy of Insulin Glargine Versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in Combination With Metformin in Subjects With Type 2 Diabetes.

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart
* Drug: insulin glargine
* Drug: metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Body mass index equal to or lesser than 35.0 kg/m2 Currently treated with oral hypoglycaemic drug Exclusion Criteria: Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator Any condition that the Investigator and/or the Sponsor feel would interfere with trial participation or evaluation of results

Ages Eligible for Study
-----------------
Minimum Age: 35 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

| Intervention/Treatment |
| --- |
|Drug: biphasic insulin aspart|nan|
|Drug: insulin glargine|nan|
|Drug: metformin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | Measured at end of treatment (26 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety variables |  |  | 
| other glycemic variables |  |  | 
| Fasting plasma glucose value |  |  |
Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The researchers are trying to determine whether ovarian hormones are associated with aging processes and with the risk of developing Alzheimer's disease in women.

Detailed Description
-----------------
The proposed project will enroll 200 women. Each women will have one clinic visit consisting of cognitive testing, tests of physical function, questionnaires, and a blood draw. All women will also undergo clinical neuroimaging, which includes structural MRI, β-amyloid (Aβ) deposition on PET as a biomarker of Aβ pathology, and tau deposition on PET as a marker of neurofibrillary tangles using AV-1451.

Official Title
-----------------
Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: 18-F-Flortaucipir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who lived in Olmsted County, Minnesota between 1988 and 2007 Currently aged 55 years and older More than six months post chemotherapy or major surgery requiring general anesthesia Willing and able to sign informed consent Exclusion Criteria: Not able to read and speak English In hospice Claustrophobic If undergoing Tau imaging, cannot have QT Prolongation

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women<br>18F-Flortaucipir and 11C-Pittsburgh compound-B radioligands will be used for experimental PET imaging of beta-amyloid and neurofibrillary tau pathology | Drug: 18-F-Flortaucipir<br>* Radioligands for PET imaging of beta-amyloid and neurofibrillary tangle tau pathology<br>* Other names: 11C-Pittsburgh Compound-B;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 18F-Flortaucipir PET imaging | Cortical 18F-Flortaucipir PET imaging measured once in each participant | 1 day | 
| Pittsburgh compound-B PET imaging | Global cortical SUVR measured once in each participant | 1 day |