linjc16/ctgov huggingface dataset:
Paediatric Oximetry Algorithms - Normative Data Collection

Study Overview
=================
Brief Summary
-----------------
To undertake normative data collection of existing clinical algorithms using existing oximetry technology.

Detailed Description
-----------------
Paediatric patients who are undergoing routine diagnostic pulse oximetry, will be approached to also wear an additional oximeter at the same time so that comparisons between two oximeters and their clinical algorithms can be compared.

Official Title
-----------------
Paediatric Oximetry Algorithms - Normative Data Collection

Conditions
-----------------
Sleep Apnea Syndromes in Children

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children who have been referred for a clinical overnight pulse oximetry test Exclusion Criteria: Families who do not understand written English if an interpreter is not present for clinical reasons Times when the kit is already being used for another recruit If children do not attend with the legal guardian and so informed consent cannot be signed Patient is deemed too unwell by clinical team to be approached about the research

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 16 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oximetry Raw data | 2 second data dumps of SpO2 signals from an overnight trace | Overnight (8-10 hours) of pulse oximetry data is collected from participants and then they have completed the study. It is a single time frame of data collection. | 
| Pulse Rate Raw data | 2 second data dumps of SpO2 signals from an overnight trace | Overnight (8-10 hours) of pulse oximetry data is collected from participants and then they have completed the study. It is a single time frame of data collection |
Role of Uttarbasti in the Management of Mutra Marga Sankoch (Urethral Stricture)

Study Overview
=================
Brief Summary
-----------------
Uttarbasti is per urethral administration of medicated oil which has been recommended by Sushrut for urinary track disorders. As far as conventional surgery is concerned urethral stricture still remains a challenge due to post procedural high recurrences and complications Uttarbasti being almost non invasive, with minimum recurrences and most economical, easy to practice OPD procedure, can be the treatment of choice in the management of urethral stricture.

Official Title
-----------------
Role of Uttarbasti in the Management of Mutra Marga Sankoch (Urethral Stricture)

Conditions
-----------------
Urethral Stricture

Intervention / Treatment
-----------------
* Procedure: uttarbasti (per urethral administration of medicated oil )


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: K/C/O Urethral Stricture of either sex and from all age groups. Exclusion Criteria: With acute UTI. DM. Neoplasms of lower urinary tract BEP. With impacted calculus in urethra and bladder neck.
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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: uttarbasti (per urethral administration of medicated oil )|nan|

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
-----------------
Urethral stricture, Ayurvedic treatment, mutra marg sankoch, uttarbasti, Sesame oil, Honey, Rock salt
Outcomes of Acute Myeloid Leukemia Patients

Study Overview
=================
Brief Summary
-----------------
To assess overall survival of AML patient. To measure rate of disease free survival. rate of non relapse mortality. rate of complete remission . percentage of refractory disease. percentage of relapsed disease.

Detailed Description
-----------------
Acute myeloid leukemia (AML) is a malignant disorder of the bone marrow which is characterized by malignant clonal expansion and differentiation arrest of myeloid progenitor cells. The etiology of AML is heterogeneous. In some patients, prior exposure to therapeutic, occupational or environmental DNA-damaging agents is implicated, but most cases of AML remain without a clear etiology. The incidence of AML had been higher than that of the other three subtypes of leukemia ( [ALL], [CML], and [CLL])& accounts for the highest percentage (62%) of leukemic deaths. AML is primarily a disease of older adults. The age-adjusted incidence for those aged 65 years or older is 20.1 per 100,000 persones in comparison to 2.0 per 100,000 person-years for those younger than 65 years old. Males are 1.2-1.6 times more likely to develop AML during their lifetime as evidenced by population-based studies in the US, UK, Canada, Denmark, Australia and Algeria. AML is one of the most common form of Hematological Malignancy in adults and has the shortest survival (5-year survival = 24%). Curative therapies, including intensive chemotherapy and allogeneic stem cell transplantation, are generally applicable to a minority of patients who are younger and fit, while most older individuals exhibit poor prognosis and survival. Differences in patient outcomes are influenced by disease characteristics, access to care including active therapies and supportive care, and other factors. After many years without therapeutic advances, several new therapies have been approved and are expected to impact patient outcomes, especially for older patients and those with refractory disease.

Official Title
-----------------
Outcomes of Acute Myeloid Leukemia Patients in Assiut University Hospital

Conditions
-----------------
Acute Myeloid Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AML patients, aged more than 18yrs and received chemotherapy (aggressive or palliative). Exclusion Criteria: patients less than 18years old.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the overall survival of AML patients. | Assessment of the overall survival of AML patients. | One year |
Cancer Stem Cells in Acute Leukemia

Study Overview
=================
Brief Summary
-----------------
Descriptive study of acute leukemia patients. Bone marrow aspirate or peripheral blood samples will be analyzed by next-generation sequencing for novel gene signatures and variations in transcriptional and epigenetic regulatory elements such as ARID5B and SALL4 variants.

Official Title
-----------------
Cancer Stem Cells in Acute Leukemia

Conditions
-----------------
Acute Leukemia

Intervention / Treatment
-----------------
* Diagnostic Test: Bone marrow aspirate or peripheral blood sample collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed or relapsed acute leukemia (AML or ALL) Plan to undergo diagnostic bone marrow aspirate or peripheral blood if clinically indicated (i.e. WBC>50,000 and bone marrow contraindicated) Age 1 month to 30 years Understand and provide informed consent (subject if>18, legal guardian if<18) Exclusion Criteria: Age 0 to 4 weeks Treatment related leukemia or leukemia secondary to MDS Situations that would limit compliance with study requirements or ability to willingly give consent

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 30 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Bone marrow aspirate or peripheral blood sample collection|Collection of specimen samples only|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ARID5B polymorphism/mutation status | Correlation of our experimentally validated Arid5b dependent transcriptional signature with primary patient samples measured by patient ARID5B expression and polymorphisms. | 5 years |
Long-term Survival After Single-ventricle Palliation

Study Overview
=================
Brief Summary
-----------------
A nationwide observational study. Children operated with single-ventricle palliation between January 1994 and December 2017 operated in Sweden will be included retrospectively. Patients born with a functionally single ventricle but not undergoing surgery will not be included. Data regarding preoperative clinical characteristics and operative details will be obtained by medical records review and from The Swedish Registry of Congenital Heart Disease (SWEDCON). Using unique personal identity numbers assigned to all residents of Sweden, data from SWEDCON will be linked with dates of death.

Official Title
-----------------
Long-term Survival After Single-ventricle Palliation: A Swedish Nationwide Cohort Study

Conditions
-----------------
Heart Defects, Congenital

Intervention / Treatment
-----------------
* Procedure: Single-ventricle palliation surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Operated with single-ventricle palliation between January 1994 and May 2017 in Sweden. Exclusion Criteria: None.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Single-ventricle palliation surgery|Single-ventricle palliation surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | Until death or end of follow-up (December 31st 2017) |
Study of S1 Efficacy and Toxicity as Second-line Treatment on Inoperable or Advanced Gastric Cancers

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the study is to investigate the correlation between the efficacy and toxicity of S-1 on gastric cancers and the expression of thymidylate synthase (TS), dihydropyrimidine dehydrogenase (DPD) and orotate phosphoribosyltransferase(OPRT).

Detailed Description
-----------------
TS, DPD and OPRT are the key enzymes on the metabolic pathway of 5-Fu. We will retrospectively analyze the clinicopathological features of the patients who have suffered an inoperative or recurrent gastric cancers and administrated with S-1, such as the overall survival (OS), progressive-free survival (PFS), Lauren's classification and toxicity of S1, etc. We will divide the patients into several subgroups according to the parameters above, and then investigate the correlation between the parameters and the expression of TS, DPD and OPRT. All of the analysis is retrospective, there is no different treatment operation once the subject enrolled in this study.

Official Title
-----------------
Study of S1 Efficacy and Toxicity as Second-line Treatment on Inoperable or Advanced Gastric Cancers

Conditions
-----------------
Gastric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed, inoperable or advanced gastric cancer patients who received at most 1st line treatment Aged 18 years or older KPS performance status of ≥ 70. Anticipated life expectancy of ≥ 3 months. Adequate organ function, including bone marrow, kidney and liver. ANC ≥ 1.5×109/L and hemoglobin ≥ 8g/dL and platelet count ≥ 100×109/L Serum total bilirubin ≤ 1.5 x ULN, Serum ALT and AST ≤ 2.5 x ULN (Serum ALT and AST ≤ 5 x ULN, if liver metastases are present) Serum creatinine ≤ 1.5 x ULN and CLcr > 60 ml/min Written informed consent can be obtained prior to their participation in the trial. Exclusion Criteria: History of severe drug allergy , or an allergy to any components of S1 Subjects who have received chemotherapy, immunotherapy or radiotherapy within two weeks Alimentary tract hemorrhage, diarrhea or aphagosis at the present stage Subjects with uncontrolled CNS metastasis or epilepsia or severe psychiatric disorders. Subjects who are regarded to be unsuitable for this trial by the investigator. Subjects who are participating in other clinical trials Subjects with ascites draining or severe infection Pregnant or breast-feeding women

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 |
| --- | --- | --- |
Fetal Cardiac Magnetic Resonance in Detection of CHD

Study Overview
=================
Brief Summary
-----------------
The aim of this clinical prospective study is to investigate the value of fetal cardiac magnetic resonance imaging using a new Doppler ultrasound based gating method for the detection of congenital heart desease.

Official Title
-----------------
Fetal Cardiac Magnetic Resonance Imaging Using DUS Gating on 3T: Preliminary Experiences in Detection of CHD

Conditions
-----------------
Congenital Heart Disease, Fetal Cardiac Disorder, Heart Defect, Congenital

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: fetuses in third trimenon congenital heart defect suspected by obstetric ultrasound Exclusion Criteria: pregnant women with contraindication for native MRI
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 |
| --- | --- | --- |
| The number of heart defect characteristics detectable by DUS gated Cine MRI imaging | DUS gated Cine imaging will be applied to detect characteristics of clinically suspected congenital heart defects. | Up to 3 months after birth, cardiac MRI findings will be compared against fetal ultrasound gainst fetal ultrasounand against findings after birth (reference standard). |
SDC for Lung Cancer Patients Treated With Curative Primary or Postoperative Radiotherapy or Chemoradiation

Study Overview
=================
Brief Summary
-----------------
Introducing standardized data collection (SDC) for lung cancer patients to improve the performance of the prediction models.

Detailed Description
-----------------
All patients planned for curative primary or postoperative radiotherapy can be included. Patients will be treated according to the institutional protocol. It is optional to collect a saliva sample for genetic profiling. Follow up at five time points: 2 weeks after RT 3 months after RT 6 months after RT 12 months after RT 24 months after RT At these time points, toxicity will be assessed. In addition, patients will receive a short questionnaire by mail at eight time points.

Official Title
-----------------
Standardized Data Collection (SDC) for Lung Cancer Patients Treated With Curative Primary or Postoperative Radiotherapy or Chemoradiation (SDC Lung).

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients planned for curatively intended radiotherapy or postoperative radiotherapy Recurrent disease Exclusion Criteria: All patients planned for palliative radiotherapy

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 |
| --- | --- |
| Standard<br> | |
| Standard + saliva collection<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Two-year survival rate |  | 24 months after RT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dyspnea |  | during 24 months after RT | 
| Change in cough |  | During 24 months after RT | 
| Change in dysphagia |  | During 24 months after RT | 
| Patient-rated generic quality of life | Measured by Euroqol questionnaire | During 24 months after RT |
SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations

Study Overview
=================
Brief Summary
-----------------
This study is a multicenter, randomized, double blind, parallel group study of 3 months' treatment with SLV308 administered as a monotherapy in patients with advance stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of SLV308 as Adjunct Therapy to Levodopa in Patients With Parkinson's Disease Experiencing Motor Fluctuations.

Conditions
-----------------
Advanced Stage Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Levodopa (Pardoprunox)
* Drug: Placebo Comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of idiopathic Parkinson's Disease, advance stage of disease, Modified Hoehn & Yahr stage II-IV, presence of a recognizable 'on' and 'off' state (motor fluctuations) and stable treatment with levodopa for at least 28 days prior to randomization Exclusion Criteria: 'on-off' phenomena or 'yo-yoing' and/or an abrupt unpredictable loss of efficacy unrelated to the timing of L-DOPA administration, Prevalent expression of troublesome dyskinesias during 'on' time at waking hours, Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists, Previous surgery for the treatment of PD

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Levodopa (Pardoprunox)<br>* 12-42mg<br>|
| Placebo Comparator: 2<br> | Drug: Placebo Comparator<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to end of the maintenance period or at the early termination visit in 'off'-time as recorded in patients' home diaries. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of 'on'-time, change from baseline in the total score of the UPDRS part 2+3, and PDQ-39 |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson Disease
Omega-3 Fatty Acids and Health Effects

Study Overview
=================
Brief Summary
-----------------
The investigators want to study health effects from omega-3 fatty acids, from fishoil with different quality.

Official Title
-----------------
Omega-3 Fatty Acids and Health Effects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Omega-3
* Dietary Supplement: sun flower oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy individuals. Exclusion Criteria: Pregnant women, lactating women, chronic diseases and smoking.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: omega-3 high quality<br> | Dietary Supplement: Omega-3<br>* Capsules with omega-3 fatty acids.<br>Dietary Supplement: sun flower oil<br>* Capsules with sun flower oil.<br>|
| Experimental: omega-3 low quality<br> | Dietary Supplement: Omega-3<br>* Capsules with omega-3 fatty acids.<br>Dietary Supplement: sun flower oil<br>* Capsules with sun flower oil.<br>|
| Placebo Comparator: placebo<br> | Dietary Supplement: Omega-3<br>* Capsules with omega-3 fatty acids.<br>Dietary Supplement: sun flower oil<br>* Capsules with sun flower oil.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary and secondary oxidation products |  | baseline (0 weeks), 3 weeks and 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory markers |  | after 0,3 and 7 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Focus: health effects from omega-3 fatty acids, from fish oil with different quality