linjc16/ctgov huggingface dataset:
Effect of Manipulation of the Ankle Joint on Gait

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if manipulation of the ankle improves some measurable characteristics of how a person walks. The investigators hypothesize that the ankle will be able to bend better after manipulation and thus improve walking speed and reduce differences between the two limbs.

Official Title
-----------------
Effect of Manipulation of the Tibiotalar Joint on Gait

Conditions
-----------------
Gait

Intervention / Treatment
-----------------
* Procedure: Ankle manipulation
* Other: Sham manipulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Students will be screened for eligibility by testing their ability to perform a squat. Exclusion Criteria: a recent (within one month) ankle sprain evidence of ankle instability cardiac condition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ankle manipulation<br>Treatment will consist of manipulation of the tibiotalar joint intended to produce anterior to posterior glide of the tibia on the talus | Procedure: Ankle manipulation<br> <br> |
| Sham Comparator: Sham manipulation<br>Sham manipulative procedure of the tibiotalar joint. | Other: Sham manipulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-selected walking speed | Subjects will pick the speed they want to walk on the treadmill but will be blinded to their choice. The actual speed chosen will be recorded. | Day 1 and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in side-to-side difference in stance phase | Measurement of the change in the difference in single stance phase between the left foot and right foot. | Day 1 and 6 weeks | 
| Change in difference in step length from side-to-side | Measurement of the change in the difference in step length between the left foot and right foot | Day 1 and 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gait, Ankle joint, Manipulation, Chiropractic
Tyrosine for Methamphetamine Dependence - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate efficacy of tyrosine as a treatment for methamphetamine dependence in an outpatient treatment setting providing group psychosocial interventions. Examine effect of tyrosine on abstinence, retention in treatment, and craving.

Detailed Description
-----------------
Evaluate efficacy of tyrosine as a treatment for methamphetamine dependence in an outpatient treatment setting providing group psychosocial interventions. Examine effect of tyrosine on abstinence, retention in treatment and craving.

Official Title
-----------------
Tyrosine for Methamphetamine Dependence

Conditions
-----------------
Amphetamine-Related Disorders

Intervention / Treatment
-----------------
* Behavioral: Tyrosine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years of age. Able to provide informed consent. Desire to reduce/eliminate methamphetamine use. Used within the past two weeks. Meet DSM criteria for methamphetamine dependence. Exclusion Criteria: No dependence (within the past 12 months) for other durgs except nicotine. No history or family history of tyrosine intolerance.

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Tyrosine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving |  |  | 
| Drug use |  |  | 
| Retention |  |  | 
| Functioning |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amphetamine dependence
A Study of Limited Heart Monitoring During Non-anthracycline Trastuzumab-based Therapy in Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test whether patients with breast cancer who are being treated with non-anthracycline trastuzumab therapy can safely be monitored for heart related side effects less often than usual.

Official Title
-----------------
A Safety and Feasibility Study of Limited Cardiac Monitoring During Non-anthracycline Trastuzumab-based Therapy in Patients With HER2-positive Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Left Ventricular Ejection Fraction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >/= 18 years Newly diagnosed histologically confirmed primary invasive breast carcinoma (Stage I-IV) Pathologically confirmed HER2-positive breast cancer Planned to receive trastuzumab-based therapy for a minimum of 12 months, or started trastuzumab-based therapy within the last weeks with a planned duration of at least 12 months. Normal LV systolic function (EF greater than or equal to the institutional lower limit of normal) William and able to comply with the requirements of the protocol Exclusion Criteria: Planned to receive an anthracycline-based regimen Prior history of treatment with anthracycline chemotherapy History of cardiovascular including cardiomyopathy, heart failure, or any other clinically significant cardiovascular disease (as determined by the investigator) Uncontrolled hypertension, defined as systolic blood pressure >/= 160 mmHg and/or diastolic blood pressure >/= 90 mmHg (as determined by the investigator)

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HER2-Positive Breast Cancer<br> | Diagnostic Test: Left Ventricular Ejection Fraction<br>* LVEF assessment at baseline, 6 months, and 12 months<br>* Other names: LVEF;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Participants have HER2-positive breast cancer treated with non-anthracycline trastuzumab-based therapy. | 12 months from baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
19-045, trastuzumab, non-anthracycline trastuzumab, Memorial Sloan Kettering Cancer Center
Non-Invasive Chromosomal Evaluation of 22q11.2

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to develop and evaluate a cell-free fetal DNA test (Harmony) for non-invasive prenatal detection of 22q11.2 chromosomal deletion or duplication.

Official Title
-----------------
Non-Invasive Chromosomal Evaluation of 22q11.2 Using Cell-free Fetal DNA From Maternal Plasma

Conditions
-----------------
22q.11.2 Deletion/Duplication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is ≥18 years of age and able to provide consent or, if under the age of 18, the patient has parental consent and child assent provided as required by the governing ethics committee. If pregnant, patients must have a singleton pregnancy and be at least 10 weeks gestation at the time of the study blood draw. Patients must meet at least one of the following conditions at the time of enrollment: are pregnant with abnormal fetal cardiac findings on ultrasound and is undergoing evaluation with prenatal genetic testing or planned post-natal genetic testing in the immediate newborn period; are pregnant with fetal ultrasound findings consistent with a 22q11.2 deletion/duplication phenotype and is undergoing evaluation with prenatal genetic testing or planned post-natal genetic testing in the immediate newborn period; are pregnant with a fetus known to have a 22q11.2 deletion/duplication confirmed by genetic testing with documentation is available; are biologically related parent of an enrolled child has chromosomal deletion/duplication in the region of 22q11.2; If the site is selected to enroll control patients, they must be pregnant women undergoing prenatal genetic evaluation for 22q11.2 deletion/duplication. Exclusion Criteria Patients meeting any of the following criteria will be excluded from the study: 1. Patient has history of malignancy treated with chemotherapy and/or major surgery, or bone marrow transplant.
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 |
| --- | --- |
| Confirmed 22q.11.2 deletion/duplication<br> | |
| Suspected 22q.11.2 deletion/duplication<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of Ariosa 22q.11.2 deletion/duplication assay in prenatal patients |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Velocardiofacial Syndrome, Shprintzen Syndrome, Conotruncal Defects, Chromosomal Abnormalities, 22q, 22q.11.2, deletion, duplication
Restylane Perlane to Shape the Nasal Dorsum and/or Nasal Root

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of using Restylane Perlane to shape the nasal dorsum and/or nasal root in comparison with a no-treatment control group

Official Title
-----------------
A Randomized, Open Label, No-treatment Controlled, Multi-center, Efficacy and Safety Study Using Restylane Perlane to Shape the Nasal Dorsum and/or Nasal Root

Conditions
-----------------
Nasal Augmentation

Intervention / Treatment
-----------------
* Device: Restylane Perlane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chinese origin Subject with desire to shape the nasal dorsum and/or nasal root Subjects who, in the opinion of the investigator, can achieve a clinically meaningful aesthetic correction of their nose with ≤ 1 ml Restylane Perlane Exclusion Criteria: Subjects with previous nasal surgery, including grafts or implants to the nose area Subjects requiring filler treatment around the tip of the nose or between the eyebrows (glabella region) to achieve a good aesthetic outcome Subjects with a history of chronic sinusitis or rhinitis Subjects who have previously received aesthetic treatment in the forehead, glabellar and/or nose area with a dermal filler

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Restylane Perlane<br>Single injection of Restylane Perlane in nasal dorsum and/or nasal root | Device: Restylane Perlane<br>* Intradermal injection<br>|
| No Intervention: No-treatment control<br>No-treatment control group do not receive any treatment during the main study period | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Difference of Change in Volume (mL) at 6 Months After Baseline Versus Pre-treatment in the Nasal Dorsum/Nasal Root Between Restylane Perlane Treatment Group and No-treatment Control | The primary objective of the study was to evaluate the efficacy of Restylane Perlane in shaping the nasal dorsum and/or nasal root as compared to no-treatment control, by assessment of the primary endpoint:The change in volume will be measured using 3 D photography technique. The change in volume was calculated as the value at 6 months of treatment group compared with non-treatment group | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hyaluronic acid, no-treatment control, enhancement
FASENRA Regulatory Postmarketing Surveillance in Korea

Study Overview
=================
Brief Summary
-----------------
As part of a post approval commitment, the MFDS has requested a study to characterize safety in patients who are treated with FASENRA for severe asthma with an eosinophilic phenotype by physicians in normal clinical practice settings. This study is designed to confirm or assess the known safety profile or identify previously unsuspected adverse reactions and to evaluate the effectiveness of FASENRA under conditions of routine daily medical practice in Korea. This study will provide information on the Korean patient population that is treated with this drug.

Official Title
-----------------
FASENRA Regulatory Postmarketing Surveillance in Korea

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 years and older Patients with severe asthma with an eosinophilic phenotype eligible for first time treatment with FASENRA according to the indication as indicated in the locally approved prescribing information Patients with evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Exclusion Criteria: Hypersensitivity to the active substances or to any of the excipients Current participation in any interventional 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage (%) of AEs and SAEs in patients who are treated with FASENRA |  | 24 or 48 weeks | 
| Nature (type) of AEs in patients who are treated with FASENRA |  | 24 or 48 weeks | 
| Incidence of AEs in patients who are treated with FASENRA |  | 24 or 48 weeks | 
| Severity of AEs in patients who are treated with FASENRA |  | 24 or 48 weeks | 
| Nature of unexpected adverse drug reactions in patients who are treated with FASENRA |  | 24 or 48 weeks | 
| Incidence of unexpected adverse drug reactions in patients who are treated with FASENRA |  | 24 or 48 weeks | 
| Severity of unexpected adverse drug reactions in patients who are treated with FASENRA |  | 24 or 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of exacerbation |  | 24 or 48 weeks | 
| Numbers of hospitalizations or ER visits due to asthma exacerbation |  | 24 or 48 weeks | 
| Overall investigator's assessment on the outcome of the treatment: Well control, Partly control, Uncontrolled |  | 24 or 48 weeks |
Assessment of sTREM-1 as a Diagnostic Marker in Patients With Neutropenic Fever

Study Overview
=================
Brief Summary
-----------------
The soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) was an established biomarker useful for infection in non-neutropenic patients. In this study, we tested sTREM-1 in the patients with neutropenic fever. Pro-calcitonin (PCT) and C-reactive protein (CRP) were also measured. We planned to investigate and explore the role of sTREM-1 in early diagnosis of infection in patients with neutropenic fever.

Detailed Description
-----------------
Patients with hematological malignancies developed neutropenia after chemotherapy. We checked the serum level of sTREM-1 in patients with neutropenic fever. Those patients were classified to 2 groups: documented infection or low likelihood of infection. Their sTREM-1 level was measured and was compared with other biomarker such as CRP and procalcitonin. The value of sTREM-1 for diagnosis of infection in patients with neutropenic fever was thus evaluated.

Official Title
-----------------
Assessment of sTREM-1 as a Diagnostic Marker in Patients With Neutropenic Fever

Conditions
-----------------
Neutropenic Fever

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chemotherapy-related neutropenia (granulocytes < 0.5 × 109/l or leukocytes < 1 × 109/l) and fever (body temperature > 38.0°C over a 6 hour observation period or body temperature ≥ 38.5°C once. Exclusion Criteria: prolonged fever before presenting for admission, antibiotics therapy in the past 72 hours, more than two sites of infectious focus, concomitant solid organ malignancy and blast in hemogram.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 84 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 |
| --- | --- | --- |
Ultrasound Biomicroscopy - Apoptosis

Study Overview
=================
Brief Summary
-----------------
A group of researchers at the Ontario Cancer Institute/Princess Margaret Hospital have discovered that a very specific form of cell death 'apoptosis' can be detected using high-frequency ultrasound imaging. This type of cell death is recognized to occur in tumours in response to various different chemotherapeutic drugs and in response to radiation therapy. This group of researchers has confirmed that high-frequency ultrasound can detect apoptosis in response to tumour treatments experimentally using cell culture and experimental animal systems. The ultrasound approach is now being evaluated clinically in a 3-year clinical trial enrolling a target of 200 patients including Hodgkin's disease and non-Hodgkin's disease lymphoma patients, melanoma patients and patients with basal cell carcinoma. Our hope is to be able to use this type of imaging system in the future to clinically monitor the effects of therapy on tumours and rapidly detect tumours which are not responding so that changes in therapy can be made much quicker than presently possible.

Official Title
-----------------
Ultrasound Biomicroscopy for Monitoring Apoptosis in Lymphoma, Melanoma and Basal Cell Carcinoma Patients During Chemotherapy or Radiation Therapy

Conditions
-----------------
Lymphoma, Lymphoma, Non-Hodgkin, Melanoma, Carcinoma, Basal Cell

Intervention / Treatment
-----------------
* Procedure: high frequency ultrasound imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lymphoma patients with superficial lesions prior to starting chemotherapy or after relapse of disease patients with superficial melanoma lesions patients with superficial basal cell carcinoma lesions 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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: high frequency ultrasound imaging|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility study of the use of Ultrasound Biomicroscopy for monitoring tumour response of lymphoma and melanoma patients to chemotheapy or radiation therapy. |  |  |
Functional Outcome Measures for Head and Neck Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to identify outcome measures for cancer control in Head and Neck cancer patient populations at the University of Pennsylvania (HUP, PAH, Presby) by administering various functional outcome surveys and questionnaires about their reconstructive surgery. We hope to ultimately develop a QOL indicator that will reflect the impact of reconstructive surgery on patient's quality of life, and help with therapeutic interventions and explanation of expectations prior to surgery.

Detailed Description
-----------------
Few studies examine quality of life outcome measures with initial diagnosis, surgical procedures,perioperative measures (such as use of perioperative blood transfusion or pressors), and outcomes for cancer control and free flap survival. This sub-protocol, in conjunction with protocol #816676 (Otorhinolaryngology Research Registry) will serve as a hypothesis generating study for future research on reconstructive free flap surgery outcomes by narrowing down existing questionnaires to tailor it specifically for these patients.

Official Title
-----------------
Functional Outcome Measures for Head and Neck Patients

Conditions
-----------------
Otorhinolaryngology Subjects Undergoing Free Flap Surgery

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have consented to Otorhinolaryngology Research Registry and are undergoing free flap surgery. Exclusion Criteria: No children, pregnant women, or prisoners will be consented.

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 |
| --- | --- |
| Phase 1<br>First round of survey respondents. | Other: Survey<br> <br> |
| Phase 2<br>Second round of survey respondents. | Other: Survey<br> <br> |
| Phase 3<br>Third round of survey respondents. | Other: Survey<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of Survey | Completion of quality of life surveys. | 9 years |