linjc16/ctgov huggingface dataset:
Pharmacokinetics and Safety of PBK-1801 After Single Oral Administration in Healthy Korean Women

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the pharmacokinetic characteristics after a single dose of oral PBK-1801 in healthy Korean women for preparing the bridging data for Koreans.

Official Title
-----------------
A Single Center, Open-label Clinical Trial to Evaluate Pharmacokinetic Characteristics and Safety of PBK-1801 After Single Oral Administration in Healthy Korean Women Volunteers

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: PBK-1801
* Drug: PBK-1801
* Drug: PBK-1801


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index (BMI) between 19 and 30 kg/m² Subjects are to be in good general health according to medical history, physical examination, electrocardiograph (ECG) recording and clinical laboratory assessments showing no signs clinically significant pathology (A subject with a clinically insignificant abnormality may be included by the discretion of the investigator) Subjects are to have given their written informed consent to participate in the study and to abide by study restrictions Exclusion Criteria: History or evidence of clinically significant cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, psychiatric or other major disease Subjects who have any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract other than uncomplicated appendectomy, inflammatory bowel disease). History or current alcohol abuse or drug addiction Subjects who for any reason, are deemed by the Investigator to be inappropriate for this study

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: PBK-1801<br>* Administered orally<br>|
| Experimental: B<br> | Drug: PBK-1801<br>* Administered orally<br>|
| Experimental: C<br> | Drug: PBK-1801<br>* Administered orally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | 5 days | 
| AUClast |  | 5 days | 
| AUCinf |  | 5 days | 
| Tmax |  | 5 days | 
| T1/2 |  | 5 days | 
| CL/F |  | 5 days | 
| Vd/F |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events |  | 30 days |
Impact of Monthly High Dose Oral Cholecalciferol on Serum 25 Hydroxy Vitamin D Levels in Bariatric Surgery Subjects

Study Overview
=================
Brief Summary
-----------------
Vitamin D deficiency is common after bariatric surgery. This study is designed to determine if a high dose monthly supplement of vitamin D 3 will be effective in helping improve vitamin D status after surgery such as gastric bypass. Bariatric surgery subjects taking monthly high dose cholecalciferol supplements in addition to the standard vitamin D protocol will have a significant rise in serum vitamin D levels compared to the subjects taking only the usual vitamin D protocol.

Conditions
-----------------
Bariatric Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: morbidly obese meeting criteria for gastric bypass over age 18 Exclusion Criteria: taking medications that affect vitamin D status, elevated serum hydroxy vit D or calcium

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| cholecalciferol<br> | |
| usual treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum 25(OH)D3 |  | Change at 3 and 6 mos |
Boston Scientific Registry of Deep Brain Stimulation for Treatment of Essential Tremor (ET)

Study Overview
=================
Brief Summary
-----------------
To compile characteristics of real-world outcomes for Boston Scientific Corporation's commercially approved Deep Brain Stimulation (DBS) Systems, when used according to the applicable Directions for Use, for the treatment of Essential Tremor.

Detailed Description
-----------------
To compile characteristics of real-world outcomes using Deep Brain Stimulation (DBS) for the treatment of Essential Tremor to add to the evidence available for treatment of ET.

Official Title
-----------------
Boston Scientific Registry of Deep Brain Stimulations for Treatment of Essential Tremor (ET):ET Registry

Conditions
-----------------
Essential Tremor

Intervention / Treatment
-----------------
* Device: Deep Brain Stimulation Systems (DBS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets criteria established in the locally applicable Directions for Use (DFU) for Essential Tremor Is at least 18 years old Exclusion Criteria: Meets any contraindication in locally applicable Directions for Use

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Essential Tremor<br>Subjects with Essential Tremor being implanted with Boston Scientific Deep Brain Stimulation Systems | Device: Deep Brain Stimulation Systems (DBS)<br>* Subjects receiving DBS implant for treatment of Essential Tremor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life during the study as compared with baseline using the Quality of Life in Essential Tremor Questionnaire (QUEST) | Change in quality of life over the course of the study using QUEST | Up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Deep Brain Stimulation, Boston Scientific, Essential Tremor
Intravesical BCG Administration to Patients With Invasive Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
Patients with invasive bladder cancer will be given 3-6 treatments (based on treatment response) BCG intravesically followed by a cystectomy.

Detailed Description
-----------------
Patients with muscle invasive (≥T1) bladder cancer will be given 3-6 treatments (based on treatment response) intravesical TICE® BCG. BCG is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis. After completion of BCG treatments the patient will undergo a cystectomy. A portion of bladder tumor tissue and lymph nodes will be collected for research purposes during the cystectomy.

Official Title
-----------------
Evaluating Local and Regional Immune Responses to Intravesical BCG Administration to Patients With Invasive Bladder Cancer

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Drug: BCG strain of Mycobacterium bovis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have suspected or known invasive (≥T1) bladder cancer Be able to give informed consent Be age 18 or older Not be in an immunosuppressed state (e.g. HIV+, use of chronic steroids >1 month) Exclusion Criteria: Have non-invasive (<T1) bladder cancer Unable to give informed consent < 18 or older Is in an immunosuppressed state (e.g. HIV+, use of chronic steroids >1 month)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BCG treatment of invasive bladder cancer<br>Invasive bladder cancer treated with 3-6 weeks of intravesical BCG | Drug: BCG strain of Mycobacterium bovis<br>* Invasive bladder cancer treated with 3-6 weeks of intravesical BCG<br>* Other names: BCG;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability of BCG to Enhance Tumor Specific Immunity | The tumor specific immunity is measured by the change in T cell proliferation post-treatment compared to the pre-treatment assessment, which will require a sample size of at least 10 | At cystectomy at 3-6 weeks after BCG treatment |
Functioning Disturbance in Chronic Back Pain: Altered Muscle Metabolism

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to investigate the muscle metabolism in individuals with chronic non-specific low back pain (CNSLBP) to enhance our understanding of chronic back pain.

Official Title
-----------------
Functioning Disturbance in Chronic Back Pain: Altered Muscle Metabolism

Conditions
-----------------
Chronic Non-specific Low Back Pian

Participation Criteria
=================
Eligibility Criteria
-----------------
The NSCBP group: At least 6 patients will be included in this study. All patients referred to Vestfold Hospital Trust, Kysthospitalet, diagnosed with chronic NSCBP >3 months duration will be invited to participate in the study. The invitation will be in a written form. Exclusion Criteria: anamnesis of medical or drug abuse, surgery on the musculoskeletal system of the trunk, known congenital malformation of the spine or scoliosis, body mass index > 27 kg/m2, systemic-neurological-degenerative disease, history of stroke, psychiatric disorder, pregnancy and abnormal blood pressure. The subjects will be asked not to use any medications except for paracetamol preparations one week before examination and instructed not to perform any back-straining exercise for 48 h prior to the study, except for ordinary daily working and/or leisure activities.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 50 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 |
| --- | --- | --- |
Probiotic Intervention for Acute Stress

Study Overview
=================
Brief Summary
-----------------
Efficacy of probiotics on acute stress

Official Title
-----------------
Probiotic Intervention for Acute Stress

Conditions
-----------------
Stress

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic supplement
* Dietary Supplement: Placebo supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19-35 years SMBQ-score ≥3.75 Understand Swedish in spoken and written terms Willing and able to give written informed consent for participating in the study Intake of probiotics within two weeks prior to the start of the study Exclusion Criteria: BMI> 30 Pregnant Antibiotic treatment in the last three months Known disease (diabetes, pulmonary or cardiovascular disease, celiac disease, thyroid problems, gastrointestinal disease) or mental illness Use of psychotropic drugs, beta blockers, asthma or rheumatoid arthritis drugs, steroid drugs or local steroid treatment

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotics<br> | Dietary Supplement: Probiotic supplement<br>* Capsule containing freeze dried probiotic bacteria together with maize starch<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo supplement<br>* Capsule containing maize starch<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of the cortisol level during acute stress |  | 2.5 hours |
Safety and Metabolic Study of Highly Active Antiretroviral Therapy (HAART) in Malnourished Children With HIV

Study Overview
=================
Brief Summary
-----------------
It is unclear whether children with HIV and severe acute malnutrition can be started on highly active antiretroviral therapy (HAART) safely while they are still malnourished and the manner in which this therapy should start. This study will examine the safety, efficacy, and metabolism of children started on HAART while still severely malnourished.

Official Title
-----------------
ART Pharmacokinetics, Mitochondrial Integrity, and Antioxidant Capacity in Severely Malnourished HIV-infected Malawian Children

Conditions
-----------------
HIV, Kwashiorkor, Marasmus, Severe Acute Malnutrition

Intervention / Treatment
-----------------
* Drug: zidovudine, lamivudine, nevirapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infected about to start on HAART for the first time 6-59 months old Exclusion Criteria: also being treated for TB other chronic illness (e.g., congenital heart disease, cerebral palsy)

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 59 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kwashiorkor<br>HIV-positive children aged 6-59 months with kwashiorkor receiving nutritional rehabilitation and who are started on HAART. | Drug: zidovudine, lamivudine, nevirapine<br> <br> |
| Marasmus<br>HIV-positive children aged 6-59 months with marasmus receiving nutritional rehabilitation and who are started on HAART. | Drug: zidovudine, lamivudine, nevirapine<br> <br> |
| Control<br>HIV-positive children aged 6-59 months who are not severely malnourished and who are started on HAART for a non-nutritional reason. | Drug: zidovudine, lamivudine, nevirapine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | PK of ART in malnourished children | 6 weeks |
Aquatic Treadmill Therapy for Improving Gait, Balance, Fitness and Quality of Life in Stroke Patients

Study Overview
=================
Brief Summary
-----------------
This study aims to determine if Aquatic Treadmill Therapy is effective for improving economy of gait, gait speed, balance, and cardiovascular fitness in people with chronic stroke.

Official Title
-----------------
Safety and Efficacy of Aquatic Treadmill Therapy for Improving Economy of Gait, Gait Speed, Balance, Cardiovascular Fitness, and Quality of Life in Ambulatory Adult Stroke Patients: A Pilot Study

Conditions
-----------------
Ischemic or Hemorrhagic Stroke, Hemiparesis

Intervention / Treatment
-----------------
* Device: Aquatic treadmill training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with ischemic or hemorrhagic stroke with hemiparesis who have chronic deficits in gait, falls and/or poor fitness Exclusion Criteria: Subjects with medical co-morbidities that may affect gait and endurance.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aquatic treadmill training<br>Aquatic treadmill training (ATT) is a pool-based treadmill training that combines the three concepts of unweighting the body, treadmill training, and the resistance effects of water into one modality. | Device: Aquatic treadmill training<br>* HydroWorx aquatic therapy pool with an underwater, integrated and adjustable speed treadmill<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Number of procedure related adverse events that occurred during study. | 16 weeks |
Phototoxicity Test of Dapsone Gel in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the potential of dapsone gel and its vehicle to cause a phototoxic reaction following irradiation of the skin under controlled conditions.

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: dapsone gel
* Drug: dapsone gel vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Healthy adults. Exclusion Criteria: Skin diseases, excessive hair, tattoos, pigmentation, scars or moles that could interfere with patch application Sensitivity to adhesive bandages or tape.

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
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All participants<br>Dapsone gel and dapsone gel vehicle applied to the skin by separate occlusive patches on Day 1. | Drug: dapsone gel<br>* Patches containing dapsone gel will be applied to the skin.<br>Drug: dapsone gel vehicle<br>* Patches containing dapsone gel vehicle will be applied to the skin.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phototoxicity Irritation Potential Using a Visual Scale |  | 4 Days |
Development of a Multi-attribute Health Index: to Measure the Quality of Labour Analgesia: The QLA Index

Study Overview
=================
Brief Summary
-----------------
The findings of this research will be used to develop a scale for measuring the quality of epidural pain relief achieved during labour and vaginal delivery.

Detailed Description
-----------------
The current lack of a tool to measure the overall quality of neuraxial pain relief provided in labour analgesia trials has produced studies unable to provide clear direction to clinical care and research. Our previous work explored and described the underlying dimensions and attributes of quality neuraxial analgesia from the perspectives of labouring women as the initial phase of development of an Index to measure this as an outcome in research. We now seek to confirm our findings as well as to generate additional items (descriptors) of quality neuraxial analgesia from the perspectives of parturients and experts (obstetrical anesthesiologists and experienced labour nurses). Once generated, the full list of items will be used to in a subsequent study involving only parturients (Item Reduction phase) to develop a scale permitting global measurement of quality neuraxial labour analgesia. The resulting scale, once validated, will provide researchers with a simple global measure for quality in labour analgesia research. This scale will be used later in our program of research to assist with validation studies of the larger Multi-attribute Health Index we are developing.

Official Title
-----------------
Development of a Multi-attribute Health Index to Measure the Quality of Labour Analgesia: Psychometric Development of a Quality of Neuraxial Labour Analgesia Scale

Conditions
-----------------
Labour Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Use of neuraxial labour analgesia during the current pregnancy Native English-speakers Term pregnancies (>37-42weeks) The ability to read and write in English Provision of written informed consent. Exclusion Criteria: Women who received IM or IV narcotics within 4 hours of epidural/ combined spinal epidural (CSE) placement Women with evidence or history of maternal cognitive impairment Women who experienced a neonatal death during the current pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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 |
| --- | --- | --- |
| Psychometric instrument development study | Exploration and description of language, nature, and variability of women's pain experiences during labour and delivery. | 5-6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Women receiving labour epidural for most recent delivery