linjc16/ctgov huggingface dataset:
Effect of Postoperative Laxative on Bowel Function After Colonic Surgery

Study Overview
=================
Brief Summary
-----------------
Randomised doublet blinded study of the effect of tablet Magnesia (laxative) on post operative bowel ileus after open colonic resection. Material: 56 patients in two equal groups. Primary endpoint: Bowel function. Secondary endpoints: Intake of food and drinks.

Official Title
-----------------
Effect of Postoperative Laxative on Bowel Function After Colonic Surgery

Conditions
-----------------
Colonic Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with planned elective colonic resection Exclusion Criteria: Previous extended abdominal surgery Pregnancy Opioid or alcohol abuse

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Magnesia<br>Medical laxative | Drug: Magnesia<br>* Tablet magnesia 500mg. 2 tablet 2 times a day for a week<br>Drug: Placebo<br> <br> |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to defecation after colonic resection |  | 2-8 days |
Thyromental Height Test (TMHT) as a Predictor of Difficult Airway in Obese Patients

Study Overview
=================
Brief Summary
-----------------
Difficult airway management is a major concern for anesthetists and contributes to perioperative morbidity and mortality. The incidence of difficult intubation in the obese population with a BMI of greater than 30 has been reported to be 15.8%. Thyromental height test (TMHT) is a new bedside test for difficult airway, it is a measure of the height between the anterior borders of the mentum and thyroid cartilage. TMHT can act as a surrogate for amount of mandibular protrusion; dimensions of submandibular space; and anterior position of the larynx. It appears promising as a single anatomical measure to predict the risk of difficult laryngoscopy.

Official Title
-----------------
Validity of Thyromental Height Test (TMHT) as an Objective Predictor of Difficult Airway in Obese Patients: a Prospective Observational Cohort Study

Conditions
-----------------
Difficult Airway Intubation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged between 18-60 years old, ASA physical status II& III with BMI > 30 Kg/m2 who will undergo elective surgical procedures under general anesthesia using endotracheal intubation with conventional laryngoscopy Exclusion Criteria: Patients with neuromuscular disorders, craniofacial abnormalities, abnormal dentition, uncooperative, who need awake intubation and patients who undergoing emergency operations will be excluded

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| TMH test<br>Patient will be asked to lay supine while the head and neck maintained in a neutral position using a pillow under the head. By using digital depth gauge, the TMH will be measured from the anterior border of the thyroid cartilage directly on the thyroid notch till the anterior border of the mentum | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TMHT | Validity of TMHT for prediction of difficult airway in obese patient undergoing general anesthesia | before induction of general anesthesia |
Quality of Life in Patients With Multiple Myeloma-validation Study

Study Overview
=================
Brief Summary
-----------------
In this study, the Myeloma Patient Outcome Scale (MyPOS) will be translated from English to German. This translated version will be quantitatively and qualitatively validated with patients with multiple myeloma.

Detailed Description
-----------------
Patients with multiple myeloma (N=10) will be interviewed in the qualitative phase about their comprehension of the translated MyPOS. The questionnaire will be revised according to the results of the interviews. This culturally adapted Swiss-German MyPOS will be assessed in the quantitative phase for its' psychometric properties with 200 patients with multiple myeloma.

Official Title
-----------------
Validation of the Myeloma Patient Outcome Scale (MyPOS) Assessing the Quality of Life in Patients With Multiple Myeloma in the German Speaking Part of Switzerland

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Diagnostic Test: Myeloma Patient Outcome Scale (MyPOS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent as documented by signature confirmed histological diagnosis of multiple myeloma, age ≥ 18 years, mental capacity to give written informed consent Exclusion Criteria: inability to communicate in German participation in another clinical study more than one cancer diagnosis mental illness (i.e. psychiatric diagnosis)

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MyPOS<br> | Diagnostic Test: Myeloma Patient Outcome Scale (MyPOS)<br>* Patients complete the MyPOS questionnaire on quality of life<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychometric properties of the culturally-adapted Swiss-German Myeloma Patient Outcome Scale (MyPOS) | The primary outcome will be the scores on each item of the culturally-adapted Swiss-German MyPOS. Items are scored on a five-point Likert scale. For the analysis, the three subscales Symptoms (range: 0-52), Emotions (range:0-68) and Healthcare Support (range: 0-12) are assessed as well as the MyPOS total score (range: 0-132 ) by summing up the item scores ranging from 0-4. Higher scores reflect worse quality of life. The scores will be used to evaluate the psychometric properties of the culturally-adapted Swiss-German MyPOS: Structural validity, Internal consistency, Construct validity, Convergent and divergent validity. | upon enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
quality of life, psychometrics
Study to Assess the Safety and Tolerability of the Tor Kinase Inhibitor AZD8055

Study Overview
=================
Brief Summary
-----------------
The primary objective is to assess the safety and tolerability of AZD8055 in Japanese patients with advanced solid tumours.

Official Title
-----------------
A Phase I, Open Label, Single-centre Study to Assess the Safety and Tolerability of the Tor Kinase Inhibitor AZD8055 Administered Orally to Japanese Patients With Advanced Solid Tumours

Conditions
-----------------
Cancer, Solid Tumors, Advanced Solid Malignancies

Intervention / Treatment
-----------------
* Drug: AZD8055


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese patients with advanced solid tumors for which suitable effective standard treatment does not exist or is no longer effective Relatively good overall health other than cancer Exclusion Criteria: Poor bone marrow function (not producing enough blood cells) Poor liver or kidney function Serious concomitant illness

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD8055<br>AZD8055 will be administered orally | Drug: AZD8055<br>* Tablets, orally administered, twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of adverse events, clinical laboratory tests (clinical chemistry, haematology, coagulation, urinalysis), glucose management (s-glucose, s-insulin, haemoglobin A1c [HbA1c]), vital signs (pulse rate, blood pressure, weight and body temperature) |  | Laboratory values, vital sign, physical examination every week during Cycle 1 and 2. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the pharmacokinetic profile of AZD8055 following both single and multiple oral dosing in patients with advanced solid tumours |  | According to protocol specified schedule, the number of PK samples collected during Cycle 1 | 
| To seek preliminary evidence of the anti-tumour activity of AZD8055 in patients with advanced solid malignancies as measured by objective tumour response (according to RECIST criteria) |  | Every cycle | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase I, cancer, solid tumors, advanced solid malignancies, dose escalation, mTOR Kinase Inhibitor, Japanese
Monitoring Radiation Induced Cardiac Damage by Blood Markers

Study Overview
=================
Brief Summary
-----------------
Rationale: Radiation induced cardiac toxicity after treatment for intrathoracic tumours is a clinically relevant problem. So far, no clinical prediction models exist for cardiac toxicity. In particular, the relationship between radiation dose parameters and the risk of cardiac toxicity remains to be determined. Clinical prediction models for cardiac toxicity are difficult to obtain, e.g. due to long latency time. Therefore, objective surrogate markers, for cardiac toxicity such as NT pro BNP and hs-TNT, as obtained during and after treatment may be of great value. Objective: The main objective to find a correlation between the rise in NT pro BNP level and the radiation dose given to the heart.

Official Title
-----------------
Monitoring Radiation Induced Cardiac Damage by Blood Markers

Conditions
-----------------
Radiation Induced Cardiac Damage

Intervention / Treatment
-----------------
* Other: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven oesophageal- or lung cancer (adeno-, or squamous cell carcinoma or other NSCLC type) Older than 18 years Written informed consent Exclusion Criteria: Prior radiotherapy to the chest including radiotherapy for breast cancer Patients treated with palliative intent

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 |
| --- |
|Other: Blood sampling|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in percentage of rise of the level of NT pro BNP after radiotherapy |  | At 1 year after end of radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac events | A new diagnosis of: heart failure, myocardial infarction or a newly diagnosed rhythm disorder will be scored as a cardiac event. Myocardial ischaemia requiring intervention and changes in cardiac medication in case of deterioration of known heart failure will be analysed by a cardiologist to decide whether or not to score this as an event. Events will be scored according the CTCAE 4.2 criteria. | After start treatment up to 2 years after end of radiation therapy. | 
| Change in percentage of rise of hs-TNT during or after treatment |  | At day 1 start radiation therapy and at last day of radiation therapy (an expected average of 5 weeks after start of radiation therapy) and at 4 weeks, 6 months, 1 and 2 years after end of radiation therapy. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiotherapy, Cardiac, Toxicity
A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to assess whether 400mg/day of lacosamide is effective in reducing pain caused by distal diabetic neuropathy. Two dose-escalation schemes for lacosamide will be used to further determine the efficacy of the standard scheme and to evaluate the efficacy and safety of a more rapid titration scheme. Subjects will be randomly assigned to one of three treatment groups. Subjects in two of the groups will receive lacosamide at a dose of 400mg/day, but different dose-escalation schemes will be used to reach this final dose. The third group of subjects will receive a placebo. Subjects will have a 2 in 3 (66 %) chance of getting lacosamide. The maximum lacosamide dose in this trial will be 400mg/day. The maximum treatment duration will be 18 weeks, including a two-week Pre-Treatment Phase and a 12 weeks period on a stable dose of lacosamide or placebo.

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Placebo Controlled Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy Using Two Different Titration Schemes

Conditions
-----------------
Painful Diabetic Neuropathy

Intervention / Treatment
-----------------
* Drug: SPM 929


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has had symptoms of painful diabetic neuropathy for at least 6 months and has a diagnosis of diabetes mellitus (Type I or Type II). Exclusion Criteria: Subject has previously participated in this trial or subject has previously been assigned to treatment in a trial of the drug under investigation in this trial

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SPM 929|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the efficacy of LCM compared with placebo in reducing pain in subjects with painful distal diabetic neuropathy. Two titration schemes will be used; the first is a standard titration scheme such that the target dose of 400mg/day |  | 8 days and 22 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the onset of action under treatment of LCM, the effect of LCM on subjects' perception of pain, sleep, activity, and quality of life, and to further investigate the safety of LCM |  |  |
Effect of Glutamine on Gastric Emptying and Length of Parenteral Nutrition in Premature Neonates

Study Overview
=================
Brief Summary
-----------------
This study investigates the effects of enterally supplied glutamine on gastric emptying, intestinal transit, age of total enteral nutrition and age at the end of hospitalisation. Forty neonates, aged at least 2 days and free of acute illness participate in a prospective, randomised, double-blind study. All are fed with parenteral and enteral nutrition enriched with glutamine (0.7 g/kg/per day, group 1) or isonitrogenous control (group 2). Gastric emptying is analysed by sequential measure of intragastric residue by diluted polyethylene glycol (PEG) 4000. Intestinal transit is analysed by Rouge Carmin test.

Official Title
-----------------
Effect of Glutamine on Gastric Emptying and Length of Parenteral Nutrition in Premature Neonates

Conditions
-----------------
Enteral Feeding

Intervention / Treatment
-----------------
* Dietary Supplement: glutamine (dipeptiven)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature neonates aged 30-33 weeks of gestational age Aged at least 2 days and no more than 10 days Free of acute illness Written informed consent is obtained from the parent prior to enrolment. Exclusion Criteria: Premature infants with respiratory (fraction of inspired oxygen [FiO2] > 30%), or cardiovascular, liver, intestinal or acute diseases Premature infants with congenital syndrome

Ages Eligible for Study
-----------------
Minimum Age: 2 Days
Maximum Age: 10 Days

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: glutamine (dipeptiven)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastric emptying |  | at day 0, day 1, day 7 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intestinal transit |  | at day 1 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product | 
| date and duration of arrest of nutrition if necessary |  |  | 
| age of total enteral nutrition |  |  | 
| age at the end of hospitalization |  |  | 
| variation of cholescystokinin and gastrin postprandial concentration |  | at day 0 and day 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glutamine, premature neonate, gastric emptying
Interest of a Systematic Assessment of the Treatment of LUTS in the Management of BPH

Study Overview
=================
Brief Summary
-----------------
The high level of unsatisfactory outcome observed in patients treated for LUTS associated with BPH with respect to the different existing therapeutic options strongly emphasizes the need for treatment optimisation in daily practice by a careful LUTS monitoring and treatment adjustment when needed. The poorer outcome observed in patients for whom treatment has been initiated recently suggests that the duration of the disease itself may influence the patient satisfaction.To achieve this goal, we propose to systematically assess LUTS associated with BPH in patients treated for at least 6 months and to assess whether an alpha-blocker therapy initiation/modification may improve the outcome in case of persisting symptoms. We also investigate the influence of the symptom duration on the frequency of unsatisfactory outcome.

Official Title
-----------------
Interest of a Systematic Assessment of the Treatment of Lower Urinary Tract Symptoms (LUTS) in the Management of Benign Prostatic Hyperplasia (BPH) in Urology

Conditions
-----------------
Benign Prostatic Hyperplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 60 years or more suffering from LUTS/BPH AND medically treated for at least 6 months. Exclusion Criteria: Patients with prostate cancer Patients requiring surgical treatment The absence of Lower Urinary Tract Symptoms Treatment initiation for less than 6 months Cognitive disorders or other pathologies leading to the inability to give its consent to the collection of data. Refusal to participate.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| Percentage of patients treated for LUTS associated with BPH displaying unsatisfactory outcome after at least 6 months of treatment and not requiring surgical treatment. |  | 6 months |
Validation of DNA Methylation Biomarkers for Oral Cancer Detection

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the association between several methylated genes and oral cancers. A prospective case control trial is designed with sample size estimated at least 160 cases. It is expected to enroll at least 100 subjects with precancerous lesion or oral cancer, and  60 subjects with normal oral mucosa. This study is approved by the National Taiwan University Hospital Research Ethics Committee. After signing the informed consent, all of the subjects will receive an intraoral examination and the oral epithelial cells will be collected. If abnormal oral lesion is observed, it will be photographed, and the biopsy will be performed to confirm the diagnosis. For methylated gene detections, the gDNA will be extracted from the collected cells and standardized assay will be performed. Clinical sensitivity and specificity for these methylated genes will be evaluated.

Official Title
-----------------
Validation of DNA Methylation Biomarkers for Oral Cancer Detection

Conditions
-----------------
Oral Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject with age over 20. Subject agrees to sign the informed consent form. Exclusion Criteria: Subjects have history of head and neck cancer. Subjects have had received chemotherapy for cancers. Pregnant Woman Subjects whose has oral mucosal lichen planus. Subjects whose oral mucosal findings is abnormal, but the diagnosis is unknown.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| normal oral mucosa<br> | |
| oral precancerous lesion or oral cancer<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA methylation labeled | To validate the association between the methylation genes and the oral cancer | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DNA methylation, biomarkers, oral cancer