linjc16/ctgov huggingface dataset:
Development of Personalized Health Care Service in Patients With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
In order to develop effective personalized healthcare service program for breast cancer rehabilitation, we designed this study using mobile phone and clinical intervention(feedback coaching).

Official Title
-----------------
Development of Personalized Health Care Service in Patients With Breast Cancer

Conditions
-----------------
Breast Cancer, Lymphedema, Cancer-related Problem/Condition

Intervention / Treatment
-----------------
* Behavioral: Personalized health care service


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast cancer patient (age over 18), Cancer stage under 3, Android OS smartphone user Exclusion Criteria: Cancer stage over 4, Patients diagnosed with multiple cancer, Patient who can not participate rehabilitation exercise program
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breast cancer patients<br> | Behavioral: Personalized health care service<br>* Physical activity coaching, other functional outcome observation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction change | Patient subjective evaluation by survey on satisfaction | Baseline and after 2 weeks, 4 weeks of lifestyle modification | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity change | Physical activity measurement by step count | Baseline and after 2 weeks, 4 weeks of lifestyle modification | 
| Functional outcome change | (Physical)Functional outcome measurement by breast cancer patient questionnaire | Baseline and after 2 weeks, 4 weeks of lifestyle modification | 
| Quality of care change | Quality of care measurement by breast cancer patient questionnaire | Baseline and after 2 weeks, 4 weeks of lifestyle modification |
Antioxidant Functions of Lipoic Acid

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to determine whether a short treatment with lipoic acid, an antioxidant used in the treatment of diabetic neuropathy, improves blood vessel reactivity and decreases oxidant stress in persons with elevated blood cholesterol.

Detailed Description
-----------------
As per Brief Summary

Official Title
-----------------
Antioxidant Functions of Lipoic Acid

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: lipoic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Lipid criteria for inclusion are a plasma LDL between 160 and 190 mg/dl (total cholesterol usually 240-285 mg/dl) Less than 2 coronary risk factors, and already on a cholesterol-lowering diet. Exclusion criteria: Overt or clinical atherosclerosis Diabetes Currently taking cholesterol-lowering medication. Subjects with other lipid disorders Subjects taking supplemental lipoic acid, vitamin C, or vitamin E.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lipoic acid|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
-----------------
Lipoic acid, F2-isoprostanes, endothelial dysfunction, natural product
A Phase 1 Study of ARQ 197 in Patients With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1, open label, dose escalation study of ARQ 197 in patients with advanced/recurrent solid tumors. The purpose of this study is to determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197.

Official Title
-----------------
A Phase 1 Dose Escalation Study of ARQ 197 in Adult Patients With Advanced/Recurrent Solid Tumors

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: ARQ197


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who did not respond or are refractory to available therapy or for whom no standard effective systemic therapy exists. Karnofsky performance status (KPS) ≥ 70%, or Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 Patients with adequate organ function Exclusion Criteria: Anti-cancer chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks prior to the first dose of ARQ 197 Known symptomatic brain metastases Pregnant or breastfeeding Uncontrolled intercurrent illness

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>ARQ197 | Drug: ARQ197<br>* treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the preliminary anti-tumor activity and determine the pharmacokinetic profile |  |  |
The Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders

Study Overview
=================
Brief Summary
-----------------
The high percentage of failure using available non-surgical options to treat menorrhagia in women with bleeding disorders shows a continuing need for innovative treatments. This has led to development of this protocol in order to make available tranexamic acid as a potentially effective menorrhagia therapy option in women with an underlying bleeding disorder. We anticipate that Tranexamic Acid may be a beneficial choice for controlling menorrhagia in bleeding disorder patients.

Detailed Description
-----------------
Women with heavy periods and with a diagnosed bleeding disorders are prescribed cyclokapron pills to be taken during their periods. Their periods are assessed at 3 and 6 months by filling out a pictorial blood assessment chart. If the drug appears to be working with no adverse effects the patients can continue to take the medication as long as it is available with follow up with the investigator every 6 months.

Official Title
-----------------
Open Label Continuation Study for the Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders

Conditions
-----------------
vonWillebrand Disease, Hemophilia, Platelet Coagulation Disorders

Intervention / Treatment
-----------------
* Drug: Cyclokapron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all menstruating women regardless of age Women with heavy periods as measured by pictorial blood assessment chart Women diagnosed with a bleeding disorder Exclusion Criteria: Acquired defective color vision Factor VIII, Factor IX, FactorXI levels >250% An inherited thrombophilic defect detected because of a positive family or personal history of thrombosis Current use of oral contraceptives

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TA<br>on treatment | Drug: Cyclokapron<br>* (2) 500mg tablets taken by mouth every 6-8 hours<br>* Other names: tranexamic Acid;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced pictorial blood assessment chart scores from baseline |  | 3 and 6 months after start of medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increased hematocrit |  | 3 and 6 months from start of medication |
Sirolimus as Primary Therapy for the Treatment of Chronic Graft Versus Host Disease

Study Overview
=================
Brief Summary
-----------------
Evaluate the clinical activity of sirolimus in combination with cyclosporine and corticosteroids as first line therapy for the treatment of chronic Graft Versus Host Disease.

Detailed Description
-----------------
An Open Label Study of Sirolimus as Primary Therapy for the Treatment of Chronic GVHD Following Allogeneic Bone Marrow Transplant

Official Title
-----------------
An Open Label Study of Sirolimus as Primary Therapy for the Treatment of Chronic GVHD Following Allogeneic Bone Marrow Transplant

Conditions
-----------------
Graft vs Host Disease, Blood and Marrow Transplant (BMT)

Intervention / Treatment
-----------------
* Procedure: high dose chemotherapy and autologous hematopoietic cell transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- active chronic GvHD ANC > 1000/mm^3 therapeutic cyclosporine Exclusion Criteria:- uncontrolled systemic infection elevated serum creatinine

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: high dose chemotherapy and autologous hematopoietic cell transplant|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the efficacy of clinical activity of sirolimus in combination with cyclosporine and corticosteroids as first line therapy for the treatment of chronic Graft Versus Host Disease. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety of clinical activity of sirolimus in combination with cyclosporine and corticosteroids as first line therapy for the treatment of chronic Graft Versus Host Disease. |  |  |
Neuro-cognitive Bases of Joint Action

Study Overview
=================
Brief Summary
-----------------
The ability to interact with conspecifics is crucial in life, yet there is no consensus on the underlying cognitive and neural mechanisms beyond those associated with imitative behaviors. This project aims to define a coherent model of non-imitative (complementary) motor interactions. The investigators hypothesize that these might be substantially based on the ability to integrate one's own and a partner's action within a unitary, dual- person (dyadic), motor plan that incorporates a shared goal. With a novel minimally-joint paradigm the investigators will test this hypothesis and measure with behavioral measures (i.e., reaction times) whether the supposedly automatic tendency to imitate others is modulated by the need to coordinate with a partner to achieve a shared goal. This paradigm will be also applied during a functional MRI experiment to describe the underlying neurophysiological patterns; using dynamic causal modeling the investigators will measure how the brain regions relevant for dyadic motor control are functionally linked. This converging experimental strategy will permit to compare competing psychological and neural models of motor interactions in healthy participants, opening new experimental avenues for studies in adult neuropsychological patients and in children with typical and atypical social development.

Official Title
-----------------
Basi Neuro-cognitive Dell'Interazione Motoria

Conditions
-----------------
Health Behavior, Social Interaction

Intervention / Treatment
-----------------
* Behavioral: Interactivity of Experimental Condition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: right handed; no contraindication to MRI Exclusion Criteria: contraindication to MRI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Subjects<br>Healthy Subjects take part in the experimental manipulation | Behavioral: Interactivity of Experimental Condition<br>* The neurofunctional correlates of motor control will be compared between a collaborative and non-interactive condition.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaction Times | The investigators will compare Reaction Times of participants recorded during Joint Action with those recorded in Non-Joint individual condition. | 1 year | 
| BOLD activations | The investigators will study the neurofunctional activations indexed by the Blood Oxygen Level Dependent (BOLD) recorded during Joint Action will be compared to the Non-Joint actions | 1 year |
Penehyclidine for PONV Prophylaxis After Strabismus Surgery

Study Overview
=================
Brief Summary
-----------------
Patients scheduled for elective strabismus surgery under general anesthesia in the First Affiliated Hospital of Nanjing Medical University will be included in this study. Patients 1)ASA I or II, 2)aged 3-65 years, 3)scheduled for elective strabismus surgery under general anesthesia, will be included in the study. Patients 1)had prior PONV, 2)severe motion sickness, 3)a history of ophthalmic surgery, 4)had received drugs known to have antiemetic effects, will be excluded from the study. The primary aim is to evaluate the prophylaxis effect of penehyclidine(a novel long acting selective anticholinergic agent developed in China) on postoperative nausea and vomiting after strabismus surgery. Secondary outcomes include the effect of PONV risk factors and surgical technique on PONV rank score, occurance of oculocardiac reflex, time to extubation.

Official Title
-----------------
The Effect of Penehyclidine on Postoperative Nausea and Vomiting After Strabismus Surgery

Conditions
-----------------
PONV

Intervention / Treatment
-----------------
* Drug: Penehyclidine
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I or II Aged 3-65 years Scheduled for elective strabismus surgery under general anesthesia Exclusion Criteria: Had prior PONV Severe motion sickness A history of ophthalmic surgery Had received drugs known to have antiemetic effects in 24h before surgery

Ages Eligible for Study
-----------------
Minimum Age: 3 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Penehyclidine<br>Patients in this arm will receive penehyclidine after anesthesia intubation. | Drug: Penehyclidine<br>* Patients receive penehyclidine 10μg/kg(up to 0.5mg, diluted with normal saline to 0.1mg/ml) after anesthesia intubation.<br>|
| Placebo Comparator: Normal Saline<br>Patients in this arm will receive normal saline after anesthesia intubation. | Drug: normal saline<br>* Patients receive 0.1ml/kg normal saline(up to 5ml) after anesthesia intubation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of PONV | Occurance of postoperative nausea and vomiting after strabismus surgery | From extubation to 48 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Penehyclidine, PONV
ArmAssist Robotic Device for Arm Training

Study Overview
=================
Brief Summary
-----------------
ArmAssist is low cost simply robotic devise for arm training and assessment. It is suitable for extended home rehabilitation and prolonged hospital rehabilitation without therapist supervision. The device contains several games which are structured as exercise for disabled patients. The primary aim of this study is to correlate efficacy of the arm training with ArmAssist robot system to conventional care modified by duration and structure of exercise. The secondary aim of this study is to measure the correlation between standard clinical assessment scales and ArmAssist-based assessment metrics.

Conditions
-----------------
Hemiparesis

Intervention / Treatment
-----------------
* Device: ArmAssist robotic training
* Other: Conventional therapy
* Other: Extended conventional therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unilateral paresis; ability to understand and follow simple instructions; minimum ability to perform active movements, even though trunk compensation, using the shoulder and/or the elbow joints. Exclusion Criteria: bilateral impairment; severe sensory deficits in the paretic upper limb; cognitive impairment or behavioral dysfunction that would influence the ability to understand or perform the experiment; inability to provide informed consent; other current severe medical problems.
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: ArmAssist therapy<br>The group will be treated with ArmAssist robot therapy. | Device: ArmAssist robotic training<br> <br> Other: Conventional therapy<br> <br> |
| Active Comparator: Conventional therapy<br>The group will be treated with conventional therapy. | Other: Conventional therapy<br> <br> |
| Active Comparator: Extended Conventional therapy<br>The group will be treated with extended conventional therapy. | Other: Conventional therapy<br> <br> Other: Extended conventional therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl Mayer motor score for upper extremity |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ashworth score |  | 4 weeks | 
| Action research arm score |  | 4 weeks | 
| Wolf motor function test |  | 4 weeks | 
| Barthel index |  | 4 weeks |
To Brace or Not to Brace for Single Level Lumbar Fusion Pilot

Study Overview
=================
Brief Summary
-----------------
The use of a lumbar brace following single-level lumbar fusion for degenerative spondylosis (non-traumatic) is variable between surgeons. Some surgeons prefer to prescribe a brace and others do not. There is a lack of guidelines and evidence to support either treatment option. The purpose of this study is to assess feasibility and collect preliminary data to conduct a larger, definitive trial to provide evidence as to whether prescribing a brace or not results in better or equal outcomes. Imaging by CT scan, one year after surgery, will be used to analyze bone fusion (healing), and functional and pain scores from patients during their recovery will be compared to identify differences between patients who wore a brace and those who did not.

Official Title
-----------------
To Brace or Not to Brace for Single Level Lumbar Fusion: A Pilot Prospective Randomized Controlled Trial

Conditions
-----------------
Lumbar Spondylosis, Fusion of Spine

Intervention / Treatment
-----------------
* Device: Lumbar brace


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Single-level lumbar instrumented postero-lateral fusion from L2-L5 Life expectancy greater than 2 years Exclusion Criteria: Previous lumbar surgery Spine tumour/cancer Documented osteoporosis High grade (3 or 4) spondylolisthesis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Brace<br>Lumbar brace wear prescribed for 3 months post-operation | Device: Lumbar brace<br>* 3 months of lumbar brace wear<br>|
| No Intervention: No brace<br>No lumbar brace prescribed | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of enrolment | Feasibility measure to assess pilot project design. Assess ability to recruit 2 patients per month. | 12 months | 
| Rate of study completion | Feasibility measure to assess pilot project design. Evaluate study visit and study completion rates. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lumbar bone fusion | Status of bone fusion assessed radiologically by CT scan | 12 months | 
| Functional Status | The Oswestry Disability Index | 3 months, 6 months, 12 months | 
| Pain Status | Visual analog scale (0, no pain to 10, worst pain) | 3 months, 6 months, 12 months |