linjc16/ctgov huggingface dataset:
Effects of Mobile Game on Life Quality of Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether functional games can be used to improve the adherence and quality of life of breast cancer patients with chemotherapy.

Official Title
-----------------
Pilot Study : Effects of Mobile Game for Chemotherapy Side Effect Education on Life Quality of Cancer Patients

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

Intervention / Treatment
-----------------
* Device: Functional mobile game


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with breast cancer Receiving breast cancer chemotherapy Patients who are using a smartphone and agree to use a mobile functional game Exclusion Criteria: Patient with intellectual disability Diagnosed with congenital genetic disease Patients with a history of acquired brain injury such as cerebral palsy Developmental disorders, including autism Patients with language or learning disabilities

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Functional mobile game<br>Functional mobile game for chemotherapy side effect education | Device: Functional mobile game<br>* Functional mobile game for chemotherapy side effect education<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Physical Activity Questionnaires (IPAQ) | To obtain comparable estimates of physical activity | overall assessment period (3 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory (BDI) |  | overall assessment period (3 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mobile game, Breast Cancer, chemotherapy side effect
A Long Term Follow up Study of Patients Who Have Completed the PEP005-016 or PEP005-025 Studies

Study Overview
=================
Brief Summary
-----------------
This study is designed to follow up patients who have achieved complete clearance of AK lesions at the Day 57 visit having completed the PEP005-016 or PEP005-025 studies over a 12 month period to assess both recurrence of Actinic Keratosis (AK) lesions and long term safety in the selected treatment area.

Detailed Description
-----------------
A 12 month long-term follow-up study of patients who have achieved complete clearance of AK lesions at the Day 57 in the Phase 3 studies PEP005-016 or PEP005-025.

Official Title
-----------------
A 12 Month, Long-term Follow-up Study of Patients With Actinic Keratosis on the Head (Face or Scalp) Who Have Completed Day 57 in Studies PEP005-016 or PEP005-025 (REGION IIa and IIb)

Conditions
-----------------
Actinic Keratosis

Intervention / Treatment
-----------------
* Drug: Lesion count


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must have achieved complete clearance of AK lesions (lesion count = 0) at Day 57 in one of the following Peplin AK clinical studies: PEP005-016 or PEP005-025 Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures Exclusion Criteria: Concurrent participation in another research study which would involve the selected treatment area (except for any post-study follow-up visits for previous Peplin AK study) Early termination from study PEP005-016 or PEP005-025

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 |
| --- | --- |
| 1<br> | Drug: Lesion count<br>* Lesion count in area treated by study drug in a prior study. No drug will be applied during this long-term follow up study. Drug was applied during the primary study.<br>* Other names: AK lesion recurrence;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summarize treatment area recurrence of AK lesions, in the selected treatment area |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summarize long-term safety data(incidence of AEs in the treatment area) |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peplin, Actinic keratosis, PEP005
Mind Body Therapy During Geriatric Rehabilitation

Study Overview
=================
Brief Summary
-----------------
The main goal of geriatric rehabilitation following an acute illness is rapid restoration of normal activity. The key elements are pain control, restoration of bowel functions, good sleep quality, appetite and general well-being, as well as return to pre illness physical capabilities. Emphasis has recently been placed on finding innovative multi-disciplinary methods that can improve the care of elderly people who had suffered an acute illness. The aim of this prospective study is to assess the effect of mind-body therapy(including guided imagery, relaxation techniques, mediation and touch therapy) as as an adjunct to medical and physical rehabilitation in geriatric patients.

Conditions
-----------------
Patients Who Are in Need of Short or Long Term Rehabilitation Due to Neurological Event (Mainly Stroke) or Post Orthopedic Surgery

Intervention / Treatment
-----------------
* Behavioral: mind body therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inpatients,age 18 and above. Getting standard rehabilitation therapy Can fill an informed consent. Exclusion Criteria: Medically unstable patients (uncontrolled heart failure,rapid AF, severe infection, constant need of oxygen therapy). Demented patients who are unable to fill an informed consent

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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mind body intervention group<br> | Behavioral: mind body therapy<br>* mind-body therapy includes guided imagery, relaxation techniques, mediation and touch therapy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect on quality of life |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of treatment on rehabilitation |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rehabilitation, mind body therapy, integrative medicine
End-to-End Compression Anastomosis for Left-sided Colectomy Endo-CAR Study

Study Overview
=================
Brief Summary
-----------------
the purpose of this study is to evaluate the safety and effectiveness of the Niti CAR-device in the creation of colorectal anastomosis

Conditions
-----------------
Colorectal Cancer, Diverticulitis

Intervention / Treatment
-----------------
* Device: Niti CAR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient age over 18 Patient schedule for colonic surgery requiring E-t-E anastomosis Patient is able to understand and to sign the Informed Consent Form Exclusion Criteria: Patient has known allergy to Nickel Patient with bowel obstruction, strangulation, peritonitis, perforation, local or systemic infection Patient on regular steroid medication Patient with preexisting sphincter problems or evidence of extensive local disease of the pelvis Patient following radiation (that compromised the anastomosis) Patient who are undergoing a defunctioning stoma Patient with contraindication to general anesthesia Patient who is currently participating in other clinical trial Patient who refuse consent

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Niti CAR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functioning anastomosis & no occurrence of adverse events related to device use |  | during hospitalization and until 3 months after discharge |
Quality of Life and Acupuncture on Chronic Pain: A Randomized Study Before and After Performing

Study Overview
=================
Brief Summary
-----------------
Chronic pains can affect the life quality. This study has performed in the first time in Mashhad.The purpose of the present study was to examine the effect of acupuncture on the life quality of 150 patients who suffered from chronic pain. Some people like performing acupuncture because they believed it's free of risks and beneficial. In order to achieve this purpose, we had examined the life quality of the patients before and after acupuncture. This study was randomly performed on 150 patients aged between 17-75. They were suffering from chronic pain. The questionnaire is based on WHO QOL. The questionnaires were filled out once before acupuncture and once 12 weeks after it.

Detailed Description
-----------------
This study was completed on time.

Official Title
-----------------
Islamic Azad University and Dr Sadre Nabavi Clinic

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Procedure: acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged between 17 - 75 years old, suffering from arthritis pains, migraine backaches, muscular spasms, pains in the neck, and in the knee duration of disease over 1 year Exclusion Criteria: tacking pain relief pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 75 Years

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

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

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: accupuncture,<br>The patients went through acupuncture for 8 -10 sessions and either once or two times a week. The number and the place of needles were 8 -12 for each patient which were located on the right place. | Procedure: acupuncture<br>* The patients went through acupuncture for 8 -10 sessions and either once or two times a week. The number and the place of needles were 8 -12 for each patient which were located on the right place.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life improvement |  | up to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acupuncture, quality of life
Peer Coaching for Low-Income Patients With Diabetes in Primary Care

Study Overview
=================
Brief Summary
-----------------
Patients with diabetes who are counseled by a peer coach (another patient with diabetes) will have improved glycemic control compared with usual care patients.

Detailed Description
-----------------
Peer coaches have controlled diabetes, patient study subjects have poorly controlled diabetes.

Official Title
-----------------
Peer Coaching for Low-Income Patients With Diabetes in Primary Care

Conditions
-----------------
Diabetes Type 2

Intervention / Treatment
-----------------
* Behavioral: Usual care
* Behavioral: Health coaching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes with most recent HbA1c 8 or above in past 6 months. Exclusion Criteria: Dementia, Life expectancy less than 6 months, Inability to speak English or Spanish.

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health coaching<br>Patients with poorly controlled diabetes will receive counseling from a peer health coach -- a patient with diabetes trained in health coaching | Behavioral: Health coaching<br>* Peer health coaches will counsel patients with diabetes<br>* Other names: Peer support;|
| Active Comparator: Usual care<br>Patients will receive usual care | Behavioral: Usual care<br>* Patients will receive their usual medical care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c level |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL cholesterol level |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes
Tight Achilles Tendon, Hyperpronation and Anterior Knee Pains

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the prevalence of pain in the anterior part of the knee, amongst youngsters between 16 and 18 years of age. Furthermore, this trial intends to study the connection between the pain, hyperpronation of the foot and tight Achilles tendon. We want to find out if there is a need of an early effort in terms of information, training and/or support for the shoes.

Detailed Description
-----------------
All students (around 300) between 16 and 18 years of age from one Gymnasium, receives a questionnaire. They are asked to answer whether they have had pain in the anterior part of their knee within the last month. If so they are invited to participate in a scientific study. An equivalent group with no pain are invited to participate as a control group. In both groups navicular drop and drift will be measured together with the dorsal flexion. The investigations are made single-blinded as the investigators do not know if the patient has pain or not.

Official Title
-----------------
Is There a Connection Between a Tight Achilles Tendon, Hyperpronation of the Foot and Pain in the Anterior Part of the Knee

Conditions
-----------------
Anterior Knee Pain Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent, and for those being under 18 years of age, their parents signature. Anterior knee pain syndrome and for the control group: no knee pain syndrome Exclusion Criteria: Former knee surgery Any form of arthritis Diagnosed meniscus or other injuries in the knee

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 18 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tight Achilles Tendon, Hyperpronation of the foot
Effects of Tea Catechin Extracts on Oxidative Damage

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to clarify the effects of tea catechin extracts on the frequency changes of micronuclei in peripheral lymphocytes compared with other oxidative stress markers in late middle aged healthy volunteers

Detailed Description
-----------------
Experimental studies have revealed that tea catechin extracts induce preventive effects on oxidative stress, but there have been few clinical trials conducted to verify the effects. Also, there have been few clinical markers indicating oxidative damage, and therefore, more accurate and reliable markers have been expected. The study is designed for evaluating the effects of tea catechin extracts on the frequency changes of micronuclei in peripheral lymphocytes as the indicator of oxidative damage, compared with other oxidative stress markers in late middle aged healthy volunteers.

Official Title
-----------------
Effects of Tea Catechin Extracts on the Frequency Changes of Micronuclei in Peripheral Lymphocytes in Late Middle Aged Healthy Volunteers

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

Intervention / Treatment
-----------------
* Dietary Supplement: catechin extracts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 40 to 65 years old healthy volunteers obtained written informed concent before participation Exclusion Criteria: participant who is not able to refrain from drinking tea for 2 weeks during the study participant taking supplements or herbal products including folate, vitamin B, C, E, coenzyme Q10, calcium, for 2 weeks before the study participant taking supplements or herbal products including folate, vitamin E for 3 months before the study participant possessing tea allergy

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: catechin<br>catechin capsule group | Dietary Supplement: catechin extracts<br>* comparison with placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the frequency changes of micronuclei in peripheral lymphocytes |  | After seven days untervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of markers of oxidative damage, as measured by 8-hydroxyguanosine (8-OHdG), vitamin C, folate, homocysteine |  | After seven days intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
catechin, oxidative stress, chromosome damage, aged
Fasting Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil 40 mg tablets to Sankyo's Benicar® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fasting conditions.

Official Title
-----------------
Single-Dose Fasting In Vivo Bioequivalence Study of Olmesartan Medoxomil Tablets (40 mg; Mylan) to Benicar® Tablets (40 mg; Sankyo) in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: Olmesartan Medoxomil Tablets 40 mg
* Drug: Benicar® Tablets 40 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, adult subjects, 18 years and older able to swallow medication Exclusion Criteria: institutionalized subjects history of any significant disease use of any prescription or OTC medications within 14 days of start of study received any investigational products within 30 days prior to start of study

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Olmesartan Medoxomil Tablets 40 mg | Drug: Olmesartan Medoxomil Tablets 40 mg<br>* 40mg, single dose fasting<br>|
| Active Comparator: 2<br>Benicar® Tablets 40 mg | Drug: Benicar® Tablets 40 mg<br>* 40mg, single dose fasting<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. |  | blood collections through 48 hours |