linjc16/ctgov huggingface dataset:
Botulinum Toxin in Burning Mouth Syndrome

Study Overview
=================
Brief Summary
-----------------
The effect of botulinum neurotoxin type A intradermal injection in will be evaluated in 4 patients with clinical diagnosis of burning mouth syndrome involving the anterior two-thirds of the tongue and the lower lip for at least 6 months, refractory to common pharmacological treatments. Pain severity will be measured by the visual analog scale (VAS) indicating average week pain before injection. Each patient will be injected with a total dose of 16 units (dilution: 2 ml saline) of incobotulinumA: 4 units into each side of the lower lip and 4 units into each antero-lateral side of the tongue. In order to determine if a placebo effect may be involved, we will inject 2 additional patients with saline solution using the same volumes and the same injection sites. Patients will be evaluated at 48 hours and then at 4, 8, 12, 16 and 20 weeks after the treatment. Patients treated with placebo will be treated after 4 weeks with incobotulinumA with the same dose reported above.

Official Title
-----------------
Botulinum Toxin in Burning Mouth Syndrome

Conditions
-----------------
Burning Mouth Syndrome

Intervention / Treatment
-----------------
* Drug: Botulinum Neurotoxin Type A
* Other: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: burning mouth syndrome Exclusion Criteria: any other mouth disorder
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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum toxin type A<br>Botulinum neurotoxin injections | Drug: Botulinum Neurotoxin Type A<br>* topical injection<br>|
| Placebo Comparator: Placebo<br>Normal saline solution injections | Other: Normal saline<br>* topical injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 0-100 mm Visual Analog Scale (VAS) improvement |  | 1 month |
Impact of Transfusional Practice on the Morbidity and Mortality of Patients in Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
This study will allow correlating transfusion monitoring and patients' prognostic according to the chosen outcome criteria. These data could thus represent a basis for transfusion recommendations, except for intensive care and vital emergencies. It will also bring information about the actual transfusion monitoring in intensive care unit (ICU), in the period following the stay in the ICU and after hospital discharge.

Official Title
-----------------
Impact of Transfusional Practice on the Morbidity and Mortality of Patients in Intensive Care

Conditions
-----------------
Transfusion Related Complication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patient admitted to medical and surgical resuscitation units of Besançon and Dijon university hospitals, all causes considered Patient admitted between 1st January 2012 to 31st December 2017
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 |
| --- | --- | --- |
| Survival at 90 days after leaving ICU | All-cause mortality 90 days after leaving ICU | Day 90 |
Canadian Observational Study Evaluating the Long-term IMPACT of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Modulators on People With CF

Study Overview
=================
Brief Summary
-----------------
This observational study intends to investigate health trends and data in cystic fibrosis patients all across Canada that are receiving modulator treatment so researchers can determine if CFTR treatments are effective over a long period of time and if so, which treatments work best for each individual. The study will collect clinical data from routine standard of care, patient reported outcomes via survey data and samples for a biobank.

Official Title
-----------------
Canadian Observational Study Evaluating the Long-term IMPACT of CFTR (Can-IMPACT CF)

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: Trikafta


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prescribed a CFTR modulator therapy and planning to commence modulator therapy within 30 days OR planning to switch modulator therapies within 30 days Participates in the Canadian Cystic Fibrosis Registry (CCFR) Informed consent by participant, or parent/legal guardian or assent Exclusion Criteria: Known contraindications to CFTR modulator therapy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-Therapy Participants<br>All CF people with CF who do not have any known contraindications to CFTR modulator therapy and will be initiated on CFTR modulator therapy by their treating physician as part of clinical care are eligible and will be asked to participate in this study. | Drug: Trikafta<br>* Highly Effective CFTR Modulator Therapy<br>* Other names: Elexacaftor/Tezacaftor/Ivacaftor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the long-term pulmonary and nutritional effects of CFTR modulators. |  | 5 years | 
| To assess the long-term impact of CFTR modulators on patient-reported outcome measures including quality of life, disease burden, and physical activity. |  | 5 years | 
| To establish a bio-repository to enable further investigations of the effectiveness of CFTR modulator therapies on biological markers and predictors of response. |  | 5 years | 
| To establish the benefits of CFTR modulators compared to propensity-score matched historic CF populations followed in the Canadian CF registry. |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trikafta, Cystic Fibrosis, CFTR Modulator Therapy, Respiratory Disease
Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a single dose of pegfilgrastim is able to reduce the time of severe neutropenia in patients receiving induction and consolidation myelosuppressive chemotherapy for de novo acute myeloid leukemia similar to filgrastim.

Official Title
-----------------
A Multicentre, Double-Blind, Randomised Phase 2 Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)

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

Intervention / Treatment
-----------------
* Drug: filgrastim
* Drug: pegfilgrastim


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Histologically confirmed de novo AML as evidenced by absence of an antecedent hematologic disease of > 1 months duration, prior chemotherapy, prior radiation therapy or myelodysplastic cytogenetics (as per exclusion criteria) Life expectancy, with treatment, > 3 months Age > 18 years ECOG performance status 0, 1 or 2 Adequate organ function to receive protocol specified chemotherapy Exclusion Subjects in blast transformation of chronic myeloid leukaemia (CML) Patients with secondary AML (Received previous chemotherapy or radiotherapy) Previous treatment for AML Patients with AML FAB type M3 (Acute Promyelocytic Leukemia, APL) or M7 High risk (Unfavourable) cytogenetics [(-5/del(5q), -7/del(7q), t(8;21) with del (9q) or complex karyotype, inv(3q), abn 11q23, 20q, 21q, del(9q), t(6;9), t(9;22), abn 17p, complex karyotypes(>3 abnormalities)]

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pegfilgrastim<br>Pegfilgrastim given once after induction chemotherapy | Drug: pegfilgrastim<br>* Pegfilgrastim given once after induction chemotherapy<br>|
| Active Comparator: filgrastim<br>Filgrastim given daily after induction chemotherapy | Drug: filgrastim<br>* Filgrastim given daily after induction chemotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recover from severe neutropenia (ANC less that 0.5 X 10^9/L in chemotherapy Induction 1. |  | Induction cycle 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of severe neutropenia during induction chemotherapy |  | Induction cycle 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute myeloid leukaemia, Pegfilgrastim, Neulasta®, Neutropenia, Induction chemotherapy, Consolidation
Probucol Combined With Valsartan in Reducing Proteinuria in Diabetes Nephropathy

Study Overview
=================
Brief Summary
-----------------
This is a prospective randomized controlled, open-labeled study to identify the efficacy of probucol in combination with valsartan in patients with Diabetes nephropathy. The reduction of urinary albumin or proteinuria will be the primary outcome studied. The expected study duration will be 48 weeks.

Detailed Description
-----------------
a prospective randomized controlled, open-labeled study in patients with Diabetes nephropathy Arm 1: Valsartan + Probucol Valsartan (160mg/day) + Probucol (750mg/day) Arm 2: Valsartan + Placebo Valsartan (160mg/day) + Placebo

Official Title
-----------------
A Prospective Randomized, Controlled, Open-labeled Trial of Probucol Combined With Valsartan in Patients With Diabetes Nephropathy

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

Intervention / Treatment
-----------------
* Drug: Valsartan
* Drug: Placebo
* Drug: Probucol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes nephropathy Urinary albumin excretion 1-3g/24hours Serum creatinine < 3mg/dl Exclusion Criteria: Type 1 diabetes mellitus Renal diseases other than type 2 Diabetes nephropathy Renal artery stenosis Severe heart diseases Tuberculosis

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Valsartan (160mg/day)is given in combination with Placebo | Drug: Valsartan<br>* Valsartan (160mg/day)<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: 2<br>Valsartan (160mg/day) + Probucol (750mg/day) | Drug: Valsartan<br>* Valsartan (160mg/day)<br>Drug: Probucol<br>* Probucol (750mg/day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary albumin excretion or proteinuria at week 48 |  | 48 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes mellitus, Nephropathy, valsartan, probucol, Proteinuria
Ultrasound for Scoliosis Diagnostic Evaluation

Study Overview
=================
Brief Summary
-----------------
Scoliosis is a complex 3-dimensional deformity of the spine. It may occur at any time throughout growth and development and is typically detected through x-ray imaging. Although effective at visualizing a curve, x-ray imaging is costly and may expose children to potentially harmful ionizing radiation. This is a 30 patient study to evaluate the reliability of ultrasound, an imaging technique without radiation, to effectively measure scoliosis deformities compared to the gold-standard of x-ray.

Detailed Description
-----------------
All patients who present to Children's National Medical Center for initial evaluation of idiopathic or juvenile scoliosis will be approached.

Official Title
-----------------
Slicer+PLUS: Collaborative, Open-source Software for Ultrasound Analysis

Conditions
-----------------
Scoliosis Idiopathic, Scoliosis; Juvenile

Intervention / Treatment
-----------------
* Device: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients ages 7-17 years who present to Dr. Matthew Oetgen in the Department of Orthopaedic Surgery & Sports Medicine for clinical evaluation of scoliosis, Scoliosis curve type to include adolescent idiopathic (AIS) or juvenile, and Have x-rays taken as part of clinical evaluation Exclusion Criteria: Not willing or able to provide consent, or Had x-rays taken at an outside facility, or Any underlying neuromuscular condition or syndrome and congenital deformities

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: A single-arm unblinded group of patients will receive ultrasound imaging of spine.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Device Arm<br>This is a single arm study comparing an ultrasound with the industry standard of x-ray to detect and monitor scoliosis curvature. | Device: Ultrasound<br>* An industry standard ultrasound will be fitted with a self-tracking probe to track along the spine. The ultrasound will be performed three (3) times along the spine at initial consultation for scoliosis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging | Ability of the ultrasound to produce a radiographic measurement (e.g. coronal spinal curvature, coronal spinal rotation) within the variability of the gold standard of x-ray | 3 years |
Effect of Positive End Expiratory Pressure (PEEP) on Cerebral Oxymetry During Laparoscopy

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized that positive end expiratory pressure (PEEP) would increase the regional oxygen saturation (rSO2).

Detailed Description
-----------------
The investigators hypothesized that PEEP would increase the rSO2 during laparoscopic surgery by improving oxygenation.

Official Title
-----------------
International Reveiw Board of Gachon Univerity Gil Hospital

Conditions
-----------------
Cerebral Ischemia

Intervention / Treatment
-----------------
* Procedure: zero end-expiratory pressure
* Procedure: positive end expiratory pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA PS I or II adult patient undergoing laparoscopic low anterior resection with Trendelenburg position Exclusion Criteria: Patients with history of cerebrovascular disease, coronary occlusive disease and/or obesity (body mass index > 30) were excluded from this study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: zero end-expiratory pressure<br>not applying PEEP during operation just applying TV=IBW*6-8ml IBW = (male; 50+0.91[(Ht-cm)-152.4], female; 45.5 +0.91[(Ht-cm)-152.4], RR 8-12/min, | Procedure: positive end expiratory pressure<br>* PEEP 0 cmH2O<br>* Other names: ZEEP;|
| Active Comparator: positive end expiratory pressure<br>applying PEEP 10cmH2O during operation just applying TV=IBW*6-8ml IBW = (male; 50+0.91[(Ht-cm)-152.4], female; 45.5 +0.91[(Ht-cm)-152.4], RR 8-12/min, | Procedure: zero end-expiratory pressure<br>* positive end expiratory pressure 0 cm H2O during peumoperitoneum<br>* Other names: ZEEP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cerebral ischemia | induction 10 min, Pneumoperitoneum 20 min, after PEEP apply 40 min, time of operation ending cerebral oxymetry, cerebral perfusion pressure record | change from baseline in rSO2 at every events | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PEEP, cerebral oxymetry, laparoscopy
Information Transfer During Postoperative Handovers in the Post-anaesthesia Care Unit

Study Overview
=================
Brief Summary
-----------------
Anaesthesiology plays a key role in promoting safe perioperative care. This includes the perioperative phase in the post-anaesthesia care unit (PACU) where problems with incomplete information transfer may have a negative impact on patient safety and can lead to patient harm. The objective of this study is to analyse information transfer during postoperative handovers in the PACU. With a self-developed checklist information transfer during postoperative handovers will be documented and subsequently compared with patient information in anaesthesia records.

Official Title
-----------------
Quality of Postoperative Patient Handover in the Post-anaesthesia Care Unit: A Prospective Analysis

Conditions
-----------------
Information Transfer During Postoperative Handovers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients transferred to the PACU after surgery Exclusion Criteria: Age < 18 years patients who have surgery under local anaesthesia or in standby patients who are transferred to the surgical intensive care unit (SICU) after surgery

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 |
| --- | --- | --- |
| Quantity of Information Loss during Postoperative Handovers in the PACU |  | Two months |
Phase II Study of Midodrine for Neurogenic Orthostatic Hypotension

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Study further the safety and efficacy of the alpha-receptor agonist midodrine in patients with neurogenic orthostatic hypotension. II. Assess the quality of life in these patients with this treatment regimen.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a partially randomized, multicenter study. Patients receive oral midodrine three times a day during weeks 1 and 3-5, then either oral midodrine or placebo for weeks 6-8. Quality of life is assessed at weeks 3, 6, and 8.

Conditions
-----------------
Orthostatic Hypotension

Intervention / Treatment
-----------------
* Drug: midodrine


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Orthostatic hypotension due to autonomic nervous system failure, i.e.: Fall in systolic blood pressure (supine to standing) of at least 15 mm Hg AND Symptoms of dizziness, lightheadedness, unsteadiness with a severity of 4.5 or less on a 10 point scale in 2 of 3 evaluations over a 3 day period --Prior/Concurrent Therapy-- No concurrent sympathomimetics or alpha-receptor agonists or antagonists No concurrent drug with significant smooth muscle relaxant or constrictive properties e.g., calcium channel blockers At least 30 days since other prior investigational agents --Patient Characteristics-- Hepatic: No coagulopathy Renal: No acute nephritis or chronic renal failure Cardiovascular: No sustained supine hypertension greater than 180/110 mm Hg No congestive heart failure No myocardial infarction within the last 6 months No uncontrolled arrhythmia (ventricular tachycardia or second or third degree heart block not treated with pacemaker) No unstable angina pectoris No history of cerebral vascular accident Other: No pheochromocytoma No thyrotoxicosis No seizure disorder Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: midodrine|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
-----------------
cardiovascular and respiratory diseases, disease-related problem/condition, orthostatic hypotension, quality of life, rare disease
Type 1 Diabetes Mellitus Bone Mineral Density in Childhood and Adolescence

Study Overview
=================
Brief Summary
-----------------
Type 1 Diabetes Mellitus is a disease that has an effect on bone mineral density. It is unclear how and when it effects the bone density. The investigators are studying the effects of diabetes on bone mass compared to children without diabetes.

Official Title
-----------------
Type 1 DM Bone Mineral Density in Childhood and Adolescence

Conditions
-----------------
Type 1 Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: We will recruit children from age 5 to age 18 with a diagnosis of Type 1 DM. Children will have various lengths of time since diagnosis. Exclusion Criteria: We will exclude children on anticonvulsants or steroids and children with other concomitant illnesses that interfere with bone mass accrual, except for hypothyroidism on treatment.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum 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 |
| --- | --- |
| Case<br>Patients with Type 1 Diabetes Mellitus | |

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
-----------------
Diabetes