linjc16/ctgov huggingface dataset:
Amount of Lactose Causing Symptoms in People With Lactose Intolerance and Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
The hypothesis underlying this study is that failure to recognise the role of lactose intolerance among patients with ulcerative colitis has led to inappropriate dietary advice and treatment with drugs that contain lactose as a filler. These failures exacerbate symptoms and lead to the unnecessary use of immune suppressant drugs. There is disagreement amongst researchers regarding the amount of lactose needed to cause symptoms in those who are lactose intolerance. The general consensus is that the amount of lactose in a glass of milk (12 grams) is enough to cause mild symptoms in most patients who are lactose intolerant (1). However, there have been a number of studies and case studies that argue that much lower amounts can cause symptoms (2, 3, 4, 5). This could be as little as 0.02 grams (6). Ulcerative colitis is a chronic relapsing inflammatory disease of the colon and rectum, characterised by recurrent episodes of abdominal pain and profuse diarrhoea. The prevalence of lactose intolerance in patients with ulcerative colitis is not greater than in the general population, but there is no evidence as to whether these patients are more sensitive to lactose. This study will identify the threshold at which symptoms of lactose intolerance develop in those who have both lactose intolerance and ulcerative colitis, to provide appropriate advice and treatment in the management of patients with these conditions.

Official Title
-----------------
A Study to Determine the Threshold of Lactose Ingestion That Provokes Symptoms in Lactose Intolerant People Who Also Have Ulcerative Colitis

Conditions
-----------------
Lactose Intolerance, Ulcerative Colitis

Intervention / Treatment
-----------------
* Dietary Supplement: Lactose in water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed lactose intolerance demonstrated with a lactose intolerance test. Confirmed ulcerative colitis demonstrated with histological and radiological tests. Adherence to a lactose free diet for at least four days before the start of the study. Exclusion Criteria: Failure to adhere to a lactose free diet. Pregnancy. Unwillingness to comply with study outline.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with known lactose intolerance<br> | Dietary Supplement: Lactose in water<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of pain and diarrhoea |  | Over 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lactose intolerance, Ulcerative colitis, Lactose, Threshold
Venous Thromboembolism Prophylaxis in Medical and Surgical ICUs in a Single University Hospital

Study Overview
=================
Brief Summary
-----------------
Venous thromboembolism(VTE) is the third most common cardiovascular complication among hospitalized patients, and can even cause death. VTE often occurs in intensive care patients and there had been many efforts to prevent such complication. The American College of Chest Physicians (ACCP) had published evidence-based clinical practice guideline for VTE prophylaxis. This study focuses on how VTE prophylaxis is being performed in both medical and surgical ICUs in a single University hospital, and sees the differences in such prophylactic patterns.

Conditions
-----------------
Venous Thromboembolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU admitted patients Exclusion Criteria: patients under 20 years old

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- |
| medical ICU inpatients<br> | |
| surgical ICU inpatients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients prescribed with any measures of VTE prophylaxis in ICU | The object of this study is to see the percentage of ICU admitted patients prescribed with VTE prophylaxis, and analyze the adequacy of such prophylactic measure according to the international guideline. Moreover, difference between the VTE prophylaxis pattern of medical and surgical ICUs will also be seek for further analysis. | at the time of ICU admission an expected average of 5 months (When VTE prophylaxis for each patient is being ordered) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Venous Thromboembolism Prophylaxis, ICU
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)

Study Overview
=================
Brief Summary
-----------------
Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors such as the fragile membrane, etc. Latrunculin B serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using Latrunculin B during ICSI could serve to rescue some oocytes from the degeneration allowing for more chances of viable zygotes,

Official Title
-----------------
Latrunculin B Supplementation to ICSI Handling Medium

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: Medium Supplemented with Latrunculin B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All ICSI cycles Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Handling Medium Supplemented with Latrunculin B<br> | Other: Medium Supplemented with Latrunculin B<br>* A medium with in-house supplementation of Latrunculin B to decrease oocyte degeneration after ICSI and improve the survival rate<br>|
| No Intervention: handling Medium as it is.<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oocyte survival rate after ICSI |  | 6 days of culture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilisation rate |  | 6 days of culture | 
| Rates of blastocyst formation and quality | Number of formed and high-quality blastocysts per fertilized oocytes | 6 days of culture | 
| Clinical pregnancy rate |  | three months | 
| Implantation rate |  | 7 weeks | 
| Ongoing pregnancy rate |  | 12 weeks |
Pressure Course in the Tube Cuff During Swallowing

Study Overview
=================
Brief Summary
-----------------
Leakage of fluid from the subglottic space to the lungs occurs along the longitudinal folds within the wall of endotracheal tube (ETT) cuffs. In this project the researchers investigate the possible effect of swallowing on the pressure course in the ETT cuff.

Official Title
-----------------
Pressure Course in the Tube Cuff During Swallowing

Conditions
-----------------
Anesthesia, Intensive Care

Intervention / Treatment
-----------------
* Other: pressure measurement during swallowing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 18 years general anaesthesia or intensive care medicine treatment Exclusion Criteria: refusal of written informed consent

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| endotracheal tube<br>Patients intubated with cuffed endotracheal tubes | Other: pressure measurement during swallowing<br>* measurement of endotracheal tube cuff pressure during swallowing while recovering from anaesthesia<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
-----------------
endotracheal tube, swallowing, aspiration, cuff pressure, pneumonia
Altered Faecal Protease Activity in Irritable Bowel Syndrome Patients in China

Study Overview
=================
Brief Summary
-----------------
Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder haracterised by abdominal pain or discomfort associated with altered bowel habits,while the mechanism is still not understood.Recent advances have conceptualized the faecal supernatants of diarrhoea-predominant IBS have a substantially higher serine protease activity, while in china,almost no studies have reported about protease activity in IBS.

Conditions
-----------------
Irritable Bowel Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients fulfilling the Rome III criteria for IBS participated in the study - Exclusion Criteria: Organic gastrointestinal disorders were excluded by detailed blood and stool analyses, serological assays and colonoscopy.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IBS-D<br> | |
| IBS-C<br> | |
| Controll<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
-----------------
irritable bowel syndrome,protease activity,China
Biodesign® Otologic Repair Graft

Study Overview
=================
Brief Summary
-----------------
The post-market follow-up clinical trial of the Cook® Biodesign® Otologic Repair Graft will follow patients up to 3 months post-implantation to determine the percent of patients with complete closure of the tympanic membrane.

Official Title
-----------------
Post-market Real-world Collection Data for the Biodesign® Otologic Repair Graft

Conditions
-----------------
Tympanic Membrane Perforation, Eardrum Perforation

Intervention / Treatment
-----------------
* Device: Biodesign Otologic Repair Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient requires tympanic membrane closure. Exclusion Criteria: Life expectancy < 12 months Known sensitivity to porcine material
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Biodesign Otologic Repair Graft|The Biodesign Otologic Repair Graft is intended for use as grafting material for tympanic membrane perforation closure.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of closure | Percent of patients with complete closure of the tympanic membrane. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tympanoplasty, myringoplasty
Medical Termination of Pregnancy : Evaluation of Patients' Practices and Feelings in Brest Hospital

Study Overview
=================
Brief Summary
-----------------
This study evaluate the feelings of patients about a medical termination of pregnancy that they experienced in Brest Hospital. Patients responded to an online questionnaire assessing their feelings at each stage of the medical termination process. Their answers were associated with their medical data.

Official Title
-----------------
Medical Termination of Pregnancy : Evaluation of Patients' Practices and Feelings in Brest Hospital

Conditions
-----------------
Medical Termination of Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient having experienced a medical termination of pregnancy in Brest Hospital Medical termination of pregnancy after 14 weeks Induction for natural delivery No opposition Exclusion Criteria: Medical termination of pregnancy before 14 weeks Selective termination of pregnancy (multiple pregnancy) Caesarean Patient not speaking french Patient's refusal
Sexes Eligible for Study
-----------------
Female

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall satisfaction score | answers to a satisfaction questionnaire based on a numerical scale ranging from 0 (dissatisfaction) to 3 (satisfaction), then calculation of the overall score | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satisfaction score by indicator | satisfaction questionnaire divided into several parts according to an indicator | One day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy loss, lived from patients, medical termination of pregnancy
The Effect of Vocal Rest Versus Vocalization Following Xeomin® Injections in Spasmodic Dysphonia

Study Overview
=================
Brief Summary
-----------------
This study will compare the effects of vocal rest versus continuous vocalization for one hour immediately following botulinum toxin injections for adductor spasmodic dysphonia.

Official Title
-----------------
The Effect of Vocal Rest Versus Vocalization Following Xeomin® Injections in Spasmodic Dysphonia

Conditions
-----------------
Adductor Spasmodic Dysphonia

Intervention / Treatment
-----------------
* Behavioral: Vocal rest versus vocalization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with adductor spasmodic dysphonia (ADSD) by an experienced neurologist and otolaryngologist. ADSD patients who have been stabilized on their treatment dose for at least 2 treatment cycles. Exclusion Criteria: Diagnosed with another neurological disorder that is combined with ADSD (i.e. Parkinson's disease and ADSD). Previous history of an additional vocal pathology (i.e. vocal polps, vocal nodules, unilateral vocal fold paralysis, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 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
Interventional Model Description: The proposed study is a randomized, cross-over, clinical trial involving the comparison of two treatments (A and B) separated by a wash-out period (W). The patient participants will be randomized to one of the following two treatment orders: AWB or BWA.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vocal activity<br>The vocal activity arm will require the participant to remain in the clinic and read aloud continuously for a period of one hour after a botulinum toxin injection | Behavioral: Vocal rest versus vocalization<br>* A comparison of one hour of vocal rest versus continuous vocalization after botulinum toxin injection<br>|
| Experimental: Vocal rest<br>The vocal rest arm will require the participant to remain in the clinic and remain on complete vocal rest for a period of one hour after a botulinum toxin injection | Behavioral: Vocal rest versus vocalization<br>* A comparison of one hour of vocal rest versus continuous vocalization after botulinum toxin injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of spasmodic dysphonia symptoms | Acoustic measures and perceptual ratings of vocal spasm severity | Six weeks post-treatment | 
| Patient-reported outcome measures of symptoms and communication | Six patient-reported questionnaires related to symptoms, communication effectiveness, quality of life, and self-efficacy | six weeks post-treatment |
Pharmacoinvasive Therapy With Prourokinase

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to elucidate the efficacy and safety of pharmacoinvasive therapy by using prourokinase (prouk), a unique fibrin-specific agent, in patients with ST-segment elevation myocardial infarction (STEMI)

Official Title
-----------------
The Efficacy and Safety of Pharmacoinvasive Therapy With Prourokinase for Acute ST Segment Elevation Myocardial Infarction Patients With Expected Percutaneous Coronary Intervention Related Delay

Conditions
-----------------
ST-segment Elevation Myocardial Infarction (STEMI)

Intervention / Treatment
-----------------
* Drug: Prourokinase
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 75 years or younger, symptom onset 6 h or less before randomization, intention to undertake primary PCI, ST-segment elevation of 2 mm or more in two anterior leads or of 1 mm or more in two inferior leads if they had ST-segment elevation, or new left bundle-branch block. Exclusion Criteria: expected arrival at the catheterization laboratory less than 1 h or more than 3 h after randomization, anticipated problems with vascular access, previous enrollment to other studies, and the usual contraindications to thrombolytic therapy.

Ages Eligible for Study
-----------------
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 |
| --- | --- |
| Placebo Comparator: primary PCI<br> | Drug: Placebo<br> <br> |
| Active Comparator: prouk-PCI<br> | Drug: Prourokinase<br>* a bolus of 1.2 million IU and an infusion of 4.8 million IU in 60 min.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| angiographic parameters which can demonstrate the myocardium reperfusion, including TIMI flow grade (grade I-III), TIMI frame count (frame) and myocardial blush grade (MBG,grade 0-3). |  | 90 minutes after prourokinase bolus | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardiac events [MACE, defined as the composite of all cause-death, reinfarction, revascularization (including target vessel and non-target vessel revascularizations), or rehospitalization due to new or worsening congestive heart failure] |  | 12 month after enrollment |
Left Ventricular Free-wall Ruptrue After Acute Myocardial Infarction (LVFR-AMI)

Study Overview
=================
Brief Summary
-----------------
The Left Ventricular Free-wall Ruptrue (LVFR) is a serious complication caused high mortality.

Detailed Description
-----------------
The actual mortality of LVFR is close to 100%. Despite the mortality rate for LVFR has been decreasing with the development of reperfusion therapy, the serious complication remains a difficult challenge. The coronary anatomy distribution associated with LVFR has an interesting phenomenon. From the perspective of different coronary distribution, we can better known the risk factors related to LVFR.

Official Title
-----------------
Clinical Characteristics of Left Ventricular Free-wall Ruptrue After Acute Myocardial Infarction

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Diagnostic Test: Heart rupture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients be admitted for acute myocardial infarction (STEMI or NSTEMI) Exclusion Criteria: Non-cardiovascular comorbidity for AMI

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart rupture<br>Include left ventricular free-wall ruptrue after AMI | Diagnostic Test: Heart rupture<br>* Left ventricular free-wall ruptrue after AMI<br>|
| Non heart rupture<br>AMI with non heart rupture | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of heart ruputre | Left Ventricular Free-wall Ruptrue | Mortality 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of cardiogenic shock | Cardiogenic shock After AMI | Hospitalization 30 days | 
| Rate of cardiac arrest | Cardiac arrest After AMI | Hospitalization 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Left Ventricular Free-wall Ruptrue, Acute myocardial infarction, Coronary angiography