linjc16/ctgov huggingface dataset:
Low Dose Tadalafil for Treatment of Female OAB Syndrome: Short Term Follow up.

Study Overview
=================
Brief Summary
-----------------
Evaluation of use of low dose tadalafil 5 mg daily for treatment of female OAB syndrome

Detailed Description
-----------------
90 female patients with overactive bladder syndrome divided into 3 groups group A subjected to daily low dose tadalafil 5 mg ,group B subjected to tolterodine and group C to placebo. They are evaluated as using OAB symptoms score for 6 months follow up

Official Title
-----------------
Low Dose Tadalafil 5mg for Treatment of Female Overactive Bladder Syndrome :6 Months Follow up

Conditions
-----------------
Female Patients With Overactive Bladder Syndrome or Female Patients With Urgency or Urgency Urinary Incontinence

Intervention / Treatment
-----------------
* Drug: Low dose tadalafil 5 mg
* Drug: Tolterodine 4 Mg Oral Capsule, Extended Release
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any female with overactive bladder syndrome, urgency with or without urgency urinary incontinence Exclusion Criteria: Active Urinary tract infection neurologic abnormality Pure Stress urinary incontinence
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A Tadalafil 5 mg<br>30 patients subjected to Daily dose of tadalafil 5mg | Drug: Low dose tadalafil 5 mg<br>* Efficacy of daily low dose tadalafil 5mg for treatment of female overactive bladder syndrome or urgency with or without urgency urinary incontinence<br>|
| Active Comparator: Group B Tolterodine<br>30 patients subjected to tolterodine 4 mg daily | Drug: Tolterodine 4 Mg Oral Capsule, Extended Release<br>* To compare efficacy of low dose tadalafil 5 mg to tolterodine 4 mg extended release in treatment of female overactive bladder<br>|
| Placebo Comparator: Group C placebo<br>30 patients subjected to placebo daily | Drug: Placebo<br>* Placebo drugs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of daily low dose tadalafil 5mg in treatment of female overactive bladder syndrome: 6 months follow up | Evaluation of efficacy of tadalafil 5 mg | 6 months |
Retinol-induced Dermatitis in Aged Skin

Study Overview
=================
Brief Summary
-----------------
Topical therapy with retinoids is the only proven medical therapy for aged/photoaged human skin. However, topical therapy with retinoids often result in unwanted cutaneous dermatitis, including erythema and scaling. The reseachers intend to investigate the dose, frequency of use, and time dependence of topical retinol-induced dermatitis. The researchers intend to evaluate retinoid-induced dermatitis biochemically, including retinol regulation of retinoid responsive genes that control retinoid metabolism and serve as markers for retinoid bioactivity. The researchers will also investigate the role of EGF receptor pathway in retinoid-induced dermatitis.

Official Title
-----------------
Molecular Analyses of Retinoid-induced Dermatitis in Aged/Photoaged Human Skin

Conditions
-----------------
Aged Skin, Photoaged Skin

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Subject is at least 21 years of age Good general health No disease states, physical conditions or medications that would impair evaluation of the test sites Willingness and ability to follow protocol Signed written and witnessed informed consent form No use of oral retnoids in the past year No use of topical steroids to the treatment area in the past 2 weeks Exclusion Criteria: Has received an experimental drug or used and experimental device in the 14 days prior to admission to the study History of keloids History of hypersensitivity to lidocaine or epinephrine Pregnant or nursing women Disease states or physical condition that would impair evaluation of the test sites or compliance with the protocol History of chemical peels or laser treatments to the sites evaluated

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 Years

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 |
| --- | --- |
| 1<br>Subjects using 0.1% retinol one day per week | |
| 2<br>Subjects using 0.1% retinol three days per week | |
| 3<br>Subjects using 0.1% retinol seven days per week | |
| 4<br>Subjects using 0.5% retinol one day per week | |
| 5<br>Subjects using 0.5% retinol three days per week | |
| 6<br>Subjects using 0.5% retinol seven times per week | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinoid-induced dermatitis |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aged skin, Photoaged skin, Retinol, Topical retinoids
Skeletal Muscle Energetics and Fatiguability in Older Individuals

Study Overview
=================
Brief Summary
-----------------
The investigators are studying whether metabolic abnormalities in calf (leg) muscle in older people with and others without HIV are associated with decreased abilities to exercise.

Detailed Description
-----------------
This research is being done to better understand why some older people living with HIV experience more fatigue and difficulty exercising than older people without HIV. This is important because fatigue and problems exercising are predictors of disability and hospitalization in older individuals. We will use non-invasive magnetic resonance imaging (MRI) and spectroscopy (MRS) of the leg muscle to measure muscle metabolites and fat content, as well as blood samples measures levels of inflammation.

Official Title
-----------------
Skeletal Muscle Energetics and Fatiguability in Older Individuals

Conditions
-----------------
HIV, HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants who are >= 60 years of age HIV serostatus positive participants on stable antiretroviral therapy (ART) (no regimen change in last month) with undetectable HIV viral load (<100 copies). HIV serostatus negative participants Exclusion Criteria: Unable to understand the risks, benefits, and alternatives of participation and give meaningful consent Contraindications to MRI Significant cardiovascular, pulmonary or musculoskeletal or orthopedic disease that significantly limits exercise capacity Significant lower extremity peripheral vascular disease. Weight greater than 350 lbs Cognitive or speech impairments that would limit completion of questionnaires or fatigue reporting.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 Years

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 |
| --- | --- |
| HIV<br>Participants (ages 60 and above) with HIV | |
| Control<br>Participants (ages 60 and above) without HIV | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal mitochondrial oxidative capacity (VmaxPCr) | Maximal oxidative capacity of leg muscle measured by 31P Magnetic Resonance Spectroscopy (MRS) | Baseline | 
| Rate of PCr decline during plantar flexion exercise |  | Baseline | 
| Six minute walk distance |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeletal muscle fat content |  | Baseline | 
| Gait speed |  | Baseline | 
| Frailty status (as measured by the Fried Frailty Index) | Fried frailty index described in J Gerontol A bill Sci-Fi Med Sci-Fi 2001;56:M146-56 | Baseline |
A Study of RO5045337 [RG7112] in Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This study will determine the maximum tolerated dose and the optimal associated 4 weekly dosing schedule of RO5045337, administered as monotherapy in patients with advanced solid tumors. A first cohort of patients will receive the starting dose of 20mg/m2/day, once daily for 10 days in each 28 day cycle. Subsequent cohorts of patients will receive dose escalations, and possible changes in dosing schedule, based on tolerability and pharmacokinetic knowledge gained from prior treatment cohorts. The anticipated time on study treatment is until disease progression or intolerable toxicity.

Official Title
-----------------
A Multi-center, Open-label, Phase I Study of Single Agent R7112 Administered Orally in Patients With Advanced Malignancies, Except All Forms of Leukaemia

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: RO5045337


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >=18 years of age; solid tumor malignancies; failed prior therapies, or no standard therapy available; ECOG performance status of 0-2. Exclusion Criteria: patients receiving any other agent or therapy to treat their malignancy; pre-existing gastrointestinal disorders which may interfere with absorption of drugs; clinically significant cardiovascular disease.

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: RO5045337<br>* Administered po at escalating doses (with a starting dose of 20mg/m2/day) (5-10 cohorts)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MTD and associated dose schedule |  | Every 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response |  | Event driven | 
| Dose-limiting toxicities. |  | Throughout study | 
| Pharmacokinetic profile |  | Throughout study | 
| Comparison safety and tolerability of daily versus twice daily dosing regimens |  | approximately 18 months |
Opioid Rotation Versus Combination for Chronic Uncontrolled Cancer Pain

Study Overview
=================
Brief Summary
-----------------
For cancer patients with inadequate pain relief, a switch to an alternative opioid is the preferred option for symptomatic improvement. However, multiple opioids are often simultaneously administered for anecdotal reasons. The present study isdesigned to assess the analgesic profiles of two different strategies in chronic cancer pain: the opioid rotation from oxycodone to transdermal fentanyl and the combination of oral oxycodone and transdermal fentanyl.

Detailed Description
-----------------
Patients with uncontrolled cancer pain despite treatment of oral morphine equivalent ≥100 mg/d will be randomly assigned to oral opioids to transdermal fentanyl (rotation group) or oral oxycodone plus fentanyl (combination group). Patients answer a questionnaire that included pain severity (0 to 10) and interference items at baseline and after one week. Primary outcomes are change in pain score and treatment success.

Conditions
-----------------
Advanced Solid Cancers

Intervention / Treatment
-----------------
* Drug: oxycodone fentanyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic Uncontrolled Pain That Required Stronger Opioid Therapy Than They Have Been Taking Histologically Confirmed Solid Cancer Aged Over 18 Years Admitted in a Palliative Cancer Care Unit Exclusion Criteria: Uspected to Have Narcotic Abuse, Clinically Relevant CO2 Retention or Had an Active Skin Disease Inability to swallow oral medication, and impaired sensory or cognitive function Patients who had an active infection, uncontrolled central nervous system involvement, or on antitumor therapy of any kind

Ages Eligible for Study
-----------------
Minimum Age: 19 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

| Intervention/Treatment |
| --- |
|Drug: oxycodone fentanyl|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain score and treatment success |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain
A Randomised Comparison on the Dose Requirement Between, Levobupivacaine, Ropivacaine and Bupivacaine in Intrathecal Anaesthesia

Study Overview
=================
Brief Summary
-----------------
To determine and compare the effective intrathecal dose of levobupivacaine, ropivacaine and bupivacaine for 50% of patients in lower limb surgery

Official Title
-----------------
Minimum Local Anaesthetic Dose for Intrathecal Anaesthesia: a Randomised Comparison Between Levobupivacaine, Ropivacaine and Bupivacaine

Conditions
-----------------
Anesthesia, Conduction, Surgery

Intervention / Treatment
-----------------
* Procedure: Combined spinal epidural anaesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: body weight=40-90kg, height higher than 145cm Exclusion Criteria: Known hypersensitivity to amide local anaesthetics, patients who do not understand English and Chinese, Body mass index higher than 35 kg per sq metre

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

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

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 |
| --- |
|Procedure: Combined spinal epidural anaesthesia|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory block at 12th thoracic dermatome or above and successful conduct of the lower limb surgery up to 50 minutes after the intrathecal injection of the study drug |  | 50 minutes after the intrathecal injection of the study drug | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients who are going to have regional anaesthesia for lower limbs surgery., Leg Surgery.
Study Evaluating Sirolimus in the Treatment of Kidney Transplant

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to test whether withdrawal of calcineurin inhibitors, followed by treatment with sirolimus, may improve renal function in renal transplant recipients with chronic allograft nephropathy.

Official Title
-----------------
Sirolimus in the Treatment of Histological Defined Chronic Allograft Nephropathy

Conditions
-----------------
Kidney Failure, Kidney Diseases

Intervention / Treatment
-----------------
* Drug: Sirolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Renal transplantation Biopsy-confirmed chronic rejection Treatment with mofetil mycophenolate among cyclosporine or tacrolimus Exclusion Criteria: Transplant of any organ other than the kidney Current important infection Acute rejection within 12 weeks prior to inclusion
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 |
| --- |
|Drug: Sirolimus|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function at 12 months; Comparison between slopes of glomerular filtration rate (GFR) of one year before versus one year after start on sirolimus |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological parameters at 12 months |  |  | 
| Cumulative incidence of biopsy-confirmed acute rejection at 12 months |  |  | 
| Effect at 12 months on proteinuria, blood pressure, hyperlipidemia, and proteinuria |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney Failure, Kidney Transplant, Graft Rejection, Kidney Transplantation
Efficacy Study of Aminoflavone Prodrug to Treat Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This is a phase II study to assess the efficacy of Aminoflavone prodrug in triple negative and ER+ breast cancer.

Official Title
-----------------
A Two-Arm Open Label Phase II Study of AFP464 (Aminoflavone Prodrug) in Previously-treated ER-positive or Triple-negative Breast Cancer Patients

Conditions
-----------------
Breast Neoplasm

Intervention / Treatment
-----------------
* Drug: Aminoflavone Prodrug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ER+ or TN Breast Cancer Progression on an aromatase inhibitor if ER+ Prior treatment with taxane if TN 18 years or older Adequate organ function Measurable lesion Exclusion Criteria: symptomatic pulmonary disease brain metastases pregnant females

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aminoflavone Prodrug<br>Aminoflavone to treat ER positive breast cancer patients | Drug: Aminoflavone Prodrug<br>* Aminoflavone Prodrug administered D1, D8 of 21-day cycle<br>* Other names: AFP464;|
| Experimental: Aminoflavone Prodrug with pretreatment<br>Aminoflavone Prodrug to treat Triple Negative Breast Cancer | Drug: Aminoflavone Prodrug<br>* Aminoflavone Prodrug administered D1, D8 of 21-day cycle<br>* Other names: AFP464;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Benefit Response |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | 6 monhts | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer
the Impact of Early Palliative Care on the Survival of Locally Advanced and / or Metastatic Cholangiocarcinoma Patients

Study Overview
=================
Brief Summary
-----------------
The prognosis for cholangiocarcinoma is bad. Potentially, early management by a palliative care team could increase overall survival. We will also assess whether early management by a palliative care team could impact progression-free survival, the place of death and the date of the last chemotherapy, in particular to avoid unnecessary chemotherapy cures in an imminent end of life

Official Title
-----------------
Multicenter Retrospective Study Evaluating the Impact of Early Palliative Care on the Survival of Patients With Locally Advanced and / or Metastatic Cholangiocarcinoma (CCK)

Conditions
-----------------
Cholangiocarcinoma

Intervention / Treatment
-----------------
* Other: early palliative care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age> 18 years old intra- or extra-hepatic CCK or histologically proven vesicular adenocarcinoma Locally advanced and / or metastatic disease from the start or recurrent Initial diagnosis or recurrence between 1/01/2013 and 31/12/2019 Exclusion Criteria: <18 years old death less than one week after the diagnostic

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 |
| --- | --- |
| cholangiocarcinoma with early palliative care<br> | Other: early palliative care<br>* early palliative care<br>|
| cholangiocarcinoma without early palliative care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global survival | Global survival from the diagnosis (to the death or because of lost to follow up) | baseline |
Prognostic Significance of Fine-Needle Aspiration Cytology Features in Papillary Thyroid Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the relationship between prognosis and fine needle aspiration cytology character of papillary thyroid cancer.

Detailed Description
-----------------
Papillary thyroid carcinoma is the most common thyroid malignancy worldwide. The influence of clinicopathologic features on prognosis has been examined, but the relationship between cytologic features obtained by fine-needle aspiration (FNA) and prognosis has been minimally studied. We retrospectively studied the cytologic features with computerized morphometry in 83 patients with usual-type papillary thyroid cancer and followed them for more than 10 years except for one with metastasis at diagnosis. The cytologic features of FNA and recurrence of cancer were examined statistically.

Conditions
-----------------
Thyroid Neoplasms

Intervention / Treatment
-----------------
* Procedure: Fine needle aspiration of the thyroid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Papillary thyroid cancer diagnosed in NTUH from 1977 to 2000 Exclusion Criteria: Patient without complete medical record

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Fine needle aspiration of the thyroid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |