linjc16/ctgov huggingface dataset:
Hardwins - Squamous Cell Carcinoma Head & Neck (Surgery/RT)

Study Overview
=================
Brief Summary
-----------------
This study is examining the effects of increasing the dose of radiation given to treat head and neck cancer. Radiation doses to the primary cancer are higher than usually given; lymph glands of the neck will also be treated at a lower dose. Surgery on the lymph glands my be necessary in the future. Radiation treatments given in small fractions twice a day allows a higher dose to be delivered than if the treatment was given once a day. This study will enroll patients at three sequential increasing dose levels. Approximately 40 patients will be enrolled at each dose level.

Official Title
-----------------
A Phase II Study of Hyperfractionated Accelerated Radiotherapy Delivered With Integrated Neck Surgery for Node-positive Cases in Squamous Cell Carcinoma of the Head and Neck

Conditions
-----------------
Carcinoma, Squamous Cell

Intervention / Treatment
-----------------
* Procedure: hyperfractionated accelerated radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven squamous cell carcinoma Larynx & pharynx (except Nasopharyngeal carcinoma) Stage III & IV, but any stage hypopharynx Informed Consent Exclusion Criteria: -

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperfractionated Accelerated Radiotherapy<br>Hypofractionated Accelerated Radiotherapy with integrated neck surgery | Procedure: hyperfractionated accelerated radiotherapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicities as per CTCAE |  | 1 yr |
Chronic Gastrointestinal Sequelae of an Acute Outbreak of Bacterial Gastroenteritis in Walkerton Ontario

Study Overview
=================
Brief Summary
-----------------
Acute Bacterial dysentery leads to chronic symptoms of disturbed bowel habit in a minority of individuals. This condition known as post infectious irritable bowel syndrome (PI-IBS) remains poorly understood. This could allow material in the bowel to reach deeper tissues of the bowel wall leading to inflammation and changes in muscle and nerve function. This is also early evidence that genetic programming of people with PI-IBS prevents them from turning off inflammation once it begins. Literature suggests that IBS may develop at greater rates in individuals with pro-inflammatory genotype and that these individuals may be at increased risk of inflammatory bowel diseases (IBD).

Detailed Description
-----------------
This research will study chronic gastrointestinal problems in the residents of Walkerton, Ontario region. Determine whether acute bacterial infection is a risk factor for development of inflammatory bowel disease using the population of Walkerton as a cohort. We hypothesize that exposure to bacterial infection leads to development of post infectious irritable bowel syndrome which is associated with an increase in intestinal permeability and immune activation with low grade intestinal inflammation and that this sequence of events will trigger inflammatory bowel disease in genetically susceptible individuals

Official Title
-----------------
Chronic Gastrointestinal Sequelae of an Acute Outbreak of Bacterial Gastroenteritis in Walkerton Ontario

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be residents of the Walkerton, Ontario region at the time of Outbreak who consented to the study Exclusion Criteria: Non residents of Walkerton Ontario at the time of outbreak

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| 2<br>Unexposed to gastroenteritis | |
| 1<br>Exposed to gastroenteritis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Post Infectious Irritable Bowel Syndrome |  | 8 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
residents of Walkerton ontario at outbreak
Safety and Efficacy of Oral Miltefosine in Patients With Post Kala Azar Dermal Leishmaniasis (PKDL)

Study Overview
=================
Brief Summary
-----------------
Miltefosine efficacy will be >85%

Conditions
-----------------
PKDL

Intervention / Treatment
-----------------
* Drug: Miltefosine
* Drug: Miltefosine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12 years or older nodules and papules consistent with post kala-azar dermal leishmaniasis parasitological confirmation of Leishmania infection Exclusion Criteria: platelet count <100x 109/l, leukocyte count <2.5 x 109/l , hemoglobin < 8.0 g/100 ml , liver function tests >3 times upper limit of normal range, bilirubin >2 times upper limit of normal range, serum creatinine or blood urea nitrogen >1.5 times upper limit of normal range); any non-compensated or uncontrolled condition, lactation, pregnancy, or likelihood of inadequate contraception in females of childbearing potential for the treatment period plus 2 months thereafter; treatment with any anti-leishmanial drug within the previous 12 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 12 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12 weeks<br>miltefosine 12 weeks | Drug: Miltefosine<br>* 2.5 mg/kg/day for 12 weeks<br>|
| Experimental: 8 weeks<br>miltefosine 8 weeks | Drug: Miltefosine<br>* 2.5 mg/kg/day for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate |  | 12 months after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | gastrointestinal events: vomiting and diarrhea | during therapy: the 8 weeks of therapy for the 8 week treatment group and 12 weeks of therapy for the 12 week treatment group | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PKDL, miltefosine
A Novel Laparoscopic Hepatectomy Posture, Left Lateral Position Plus Jackknife Position

Study Overview
=================
Brief Summary
-----------------
Since the first report of laparoscopic resection of a benign hepatic tumor by Professor H. Reith in 1991, the laparoscope has been widely used in liver disease. Based on its advantages in laparoscopic vision and amplification, laparoscopic hepatectomy (LH) has been well recognized globally. Generally speaking, for lesions located in the left, front or lower part of the liver, corresponding to Couinaud segments II, III, IVb, V and VI, an LH surgery is recommended; however, for lesions located in segments VII and VIII, the surgery is high technically difficult due to poor exposure. Therefore,the investigators employ the left lateral position plus jackknife position to better expose lesions in these segments, hoping to reduce surgical time and bleeding in LH.

Official Title
-----------------
A Novel Laparoscopic Hepatectomy Posture, Left Lateral Position Plus Jackknife

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Procedure: Jackknife posture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients were diagnosed with hepatocellular carcinoma (HCC) based on the criteria established by the European Association for the Study of the Liver Tumor located in segment VI, VII, or VIII. Exclusion Criteria: Major vessel or bile duct tumor invasion, Recurrent HCC Tumor close to secondary vessels and bile ducts Patients with extrahepatic metastasis Grade C liver function, Significant surgical contraindications

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| study group<br>patients with left lateral position plus jackknife posture when perform laparoscopic hepatectomy | Procedure: Jackknife posture<br>* patients with left lateral position plus jackknife position when perform laparoscopic hepatectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | evaluate the efficiency with this posture | intraoperative | 
| Blood loss | evaluate the blood loss with this posture | intraoperative |
The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to test the hypothesis that silicone suction suspension without additional belt support does not significantly diminish the postural sway or walking performance of persons with transfemoral amputation.

Official Title
-----------------
The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees

Conditions
-----------------
Amputee

Intervention / Treatment
-----------------
* Device: Silesian suspension belt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be forty-five (45) or older; unilateral transfemoral amputee; current patients of the QEII Health Sciences Centre Amputee Service based at the Rehab Site; can walk comfortably with their prosthesis for a minimum of 5 minutes, regardless of whether they require ambulation aids (i.e. canes, walkers, etc.); are in the process of being fitted with a silicon suction liner and pin system; are competent to give informed consent or have a proxy with power of attorney; have the written permission of the attending physician to participate; be willing to take part in the study, including signing the consent after carefully reading it. Exclusion Criteria: have an unstable medical condition (e.g. angina, seizures), as determined by the attending or house physician; have major medical or neurological conditions that affect balance (specifically Parkinson's disease, stroke or Multiple Sclerosis), as determined by the physician or house staff physician; have an emotional or psychiatric problem of a type or extent that might make participation unpleasant, as determined by the attending or house physician.

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: amputee<br> | Device: Silesian suspension belt<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quiet standing balance |  |  | 
| Timed-up and Go |  |  | 
| ambulation profile |  |  | 
| questionnaire |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| demographics |  |  | 
| prosthetic components |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transfemoral amputee, silicon suspension, balance, gait
Prospective Constitution of Database Gathering Data of Patients Suffering From Glaucoma Followed at University Hospital of Grenoble

Study Overview
=================
Brief Summary
-----------------
Few publications provide information on the natural history of glaucoma, outside of clinical trials do not always reflect what is observed in common situation for various reasons (specific selection criteria and sometimes restrictive, stronger motivations patients and physicians to comply with follow-up visits and prescribed treatments, etc.). Therefore, much information on the natural history of glaucoma are unknown to date (degradation rate of visual field and visual function over time, risk of blindness in the years following diagnosis, effects of various treatments to reduce intraocular pressure and preserving visual field deterioration, etc.). Obtaining such important data to improve the management of glaucoma patients (choice of treatment methods, identification of predictors of rapid change that can make choosing more aggressive treatment and more regular monitoring, etc.) requires the establishment of cohort of patients followed and treated with the methods usually used in current practice, and besides therapeutic trial.

Official Title
-----------------
Prospective Constitution of Database Gathering Data of Patients Suffering From Glaucoma Followed at University Hospital of Grenoble

Conditions
-----------------
Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients whose age is above 18 years Patients with primary or secondary glaucoma or both sides Exclusion Criteria: Major person under guardianship or unable to consent Patient Refusal

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degradation rate of visual field and visual function in patients treated with the methods usually used in current practice |  | 15 years |
Gut Permeability Assessment in Celiac and Gluten Sensitive Children

Study Overview
=================
Brief Summary
-----------------
This study will assess the effect of gluten on gut barrier function. Investigators at the Mayo Clinic have developed a new gut permeability test using rhamnose (sugar & water solution), and are hoping to prove its effectiveness in a clinical setting.

Detailed Description
-----------------
The aim of this study is to assess effect of gluten on the gut barrier function in patients at high risk for celiac disease and non-celiac gluten sensitivity (NCGS) patients. This study will assess the gut permeability in three groups of patients 1) children who are at high risk for developing celiac disease (CD) (siblings of patients with celiac disease), 2) Children who are self-diagnosed with NCGS and 3) control group of patients matched for age and gender. Patients will undergo celiac serologic and genetic testing, after which the rhamnose test will be performed to assess the presence of increased gut permeability.

Official Title
-----------------
The Role of Gut Permeability in Developing Celiac Disease and Non-Celiac Gluten Sensitivity

Conditions
-----------------
Celiac Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
High Risk group: Sibling with a confirmed diagnosis of celiac disease No history Celiac disease or any other bowel disease Non-Celiac Gluten Sensitivity group: Self-diagnosis of gluten sensitivity No history of celiac disease or other bowel disease Healthy group: Absence of celiac disease or any other bowel disease No sensitivity to gluten

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 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 |
| --- | --- |
| High risk group<br>Children who are at high risk for developing celiac disease (siblings diagnosed with celiac disease). | |
| Non-celiac group<br>Children who are self-diagnosed with non-celiac gluten sensitivity. | |
| Control Group<br>Healthy control group (matched for age and gender). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut Permeability | Assess the effect of gluten on gut permeability in children at high risk of developing celiac disease or gluten sensitivity | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Celiac, Gluten, Sensitivity, Permeability, Non-celiac gluten intolerance, Gastrointestinal Diseases, Digestive System Diseases
Pediatric Alliance for International Neurogastrointestinal Functional Research

Study Overview
=================
Brief Summary
-----------------
To explore the predictive value of alarm signs (red flags) for a diagnosis of functional gastrointestinal disorders (FGID) in children. To assess the natural history of pain predominant functional gastrointestinal disorders (FGID) in newly diagnosed pediatric patients. To document the benefit of various treatment regimens currently employed in managing FGID. To assess the short- and long-term impact of various FGID regimens. To allow physicians to gain a better understanding of the epidemiology of FGID. Hypothesis: There are presenting symptoms or results from diagnostic tests that are more likely to associated with conditions different from FAP or IBS. Symptoms of children with FAP/IBS change overtime regardless of the treatments used.

Official Title
-----------------
Pediatric Alliance for International Neurogastrointestinal Functional Research Registry

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females ages 4 through 16 years of age (up to the day of the 17th birthday) Presenting with chronic or intermittent abdominal pain of any severity lasting at least 2 months may participate in the Registry. Exclusion Criteria: Subjects age 10 and above will be asked to complete the questionnaire themselves. Those unable to complete the questionnaire (with only some help) should not be enrolled. Patients unable to participate in the program for at least 3 years should not be enrolled (i.e., anticipated move, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 16 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 |
| --- | --- |
| FAP IBS<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Reliability and Validity of Strength Measurement of the Lower Limbs in Typically Developing Children

Study Overview
=================
Brief Summary
-----------------
Reliability of isokinetic strength measurement of the knee in typically developing children has yet been studied and seems to be good. Because in daily life activities strength of the hip- and ankle-joint muscles are also important, the investigators aim to study the reliability and validity of isokinetic strength measurements of the hip and ankle.

Detailed Description
-----------------
Intra-tester reliability of isokinetic strength measurements of the knee, hip and ankle in a Biodex System 4 device will be studied. Children will be assessed at different movement velocities using the test-positions as proposed by the manufacturer. Maximum peak torque will be established. Children will also perform functional strength assessments and the relation with the results of isokinetic strength measurements will be analysed.

Official Title
-----------------
Reliability and Validity of Strength Measurement of the Lower Limbs in Typically Developing Children

Conditions
-----------------
Children, Muscle Strength, Reproducibility of Results, Muscle Strength Dynamometer, Knee

Intervention / Treatment
-----------------
* Device: Biodex System 4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy children with good intellectual capacities Exclusion Criteria: children with chronic disease or intellectual deficiency

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

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

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

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 |
| --- | --- |
| Experimental: children<br> | Device: Biodex System 4<br>* Reliability and validity of isokinetic strength measurement of the knee, hip and ankle in typically developing children.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isokinetic strength assessment with Biodex System 4 device | Isokinetic strength measurements of the lower limb (Max and Mean Newton Meter of 3 consecutive movements) | 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional strength assessment | 30 second tests (number of trials in 30 seconds) | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
child, dynamometry, knee joint, reproducability of results, strength testing