linjc16/ctgov huggingface dataset:
Medication Therapy Management With Pharmacogenetic Testing

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the benefit and feasibility of providing pharmacogenetic (PGx) testing as part of a standard medication therapy management (MTM) session for patients taking multiple medications, a high-risk population for adverse drug reactions and non-response. Research participants will attend two MTM sessions and undergo PGx testing to inform the MTM plan. Participants will also complete 2 surveys pre and post-MTM/PGx testing. Data analysis will assess the impact of MTM/PGx testing on recommendations for drug dosing, clinical outcomes, patient satisfaction, and feasibility of service delivery. Safety issues are minimal with the primary risks being associated with loss of confidentiality, typical discomfort associated with acquiring blood samples, and genetic discrimination.

Official Title
-----------------
Assessing Feasibility and Utility of Enhancing Medication Therapy Management With Pharmacist-Delivered Pharmacogenetic Testing

Conditions
-----------------
Pharmacogenetics, Medication Therapy Management

Intervention / Treatment
-----------------
* Other: MTM with PGx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: currently prescribed 3 medications, one of which must be simvastatin or clopidogrel 18 years of age or older English speaking patients of Mahesh Patel or William Kraus at Duke Southpoint Clinic Exclusion Criteria: if patient has ever had MTM or PGx

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MTM and PGx<br>Participants attend two MTM sessions and have PGx testing | Other: MTM with PGx<br>* Patients will attend MTM sessions and receive PGx testing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with MTM and PGx | This will be assessed by a quantitative survey | 3 months after completion of MTM2 | 
| Change in clinical biomarkers associated with drug therapy | Changes in biomarkers before and after MTM/PGx will be measured. Biomarkers of study group will be compared to chart-review control | baseline and 2 months | 
| Number of recommended drug selection/dosing adjustments | Drug selection/doing changes will be compared between study population and chart-review controls | approximately 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician time to perform MTM and PGx |  | end of study, approx. 9 months |
Ropivacaine Use in Femoral Nerve Block; What is the Minimal Effective Analgesic Concentration (MEAC 90)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the minimal effective ropivacaine concentration required to provide adequate analgesic femoral nerve block in 90% of patients (MEAC90)

Detailed Description
-----------------
Before induction of GA, all patients will receive sciatic, obturator, lateral femoral cutaneous and femoral nerve blocks. The femoral nerve block will be performed using 15ml of ropivacaine which concentration relied on the response of the previous patient. Based on biased-coin design up-down sequential method: when a patient has a negative response, the next patient will receive a concentration 0.01% w/v higher. However if he has a positive response, the next patient will be randomized to receive either the same ropivacaine concentration or a concentration 0.01% w/v less. Patients with pain free recovery will be considered to have positive response. Patients' responses will be analyzed to calculate the MEAC90

Official Title
-----------------
Ropivacaine Use in Femoral Nerve Block; What is the Minimal Effective Analgesic Concentration (MEAC 90)

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients, who are scheduled for knee ligament reconstruction Exclusion Criteria: <18 y, ASA physical class greater >III BMI >40 has any contraindication for medications or techniques used in the study

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

| Intervention/Treatment |
| --- |
|Drug: Ropivacaine|all patients will receive femoral nerve block using same volume of ropivacaine but in different concentrations|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effective analgesic femoral nerve block | postoperative pain. it will be assessed using numerical rating scale (NRS). NRS, 0 = no pain; 10 = worst pain imaginable; if NRS ≥ 3, pain (ineffective block) is considered, other wise a successful block will be considered. | in recovery unit (one hour after surgery) |
Sintilimab Combined With Docetaxel for Standard Chemotherapy Failure Non-driver Gene Mutation Metastatic Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and effectiveness of Sintilimab Combined With Docetaxel in Non-driver Gene Mutation NSCLC patients who failed with double platinum-based chemotherapy

Official Title
-----------------
Multiple-center, Single-arm, Phase II Study on Sintilimab Combined With Docetaxel in Non-driver Gene Mutation Advanced NSCLC Patients Who Had Failed With Double Platinum-based Chemotherapy

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Sintilimab Combined With Docetaxel Monotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Life expectancy exceeds 3 months The investigator confirmed at least one measurable lesion according to the RECIST 1.1 standard. Exclusion Criteria: small cell lung cancer or small cell lung cancer Currently involved in interventional clinical research or treatment, or have received other research drugs or used research equipment within 4 weeks prior to the first dose; Previously received the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors (eg, CTLA-4, OX-40, CD137);

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sintilimab Combined With Docetaxel<br>Sintilimab Combined With Docetaxel for Metastatic or Non-driver Gene Mutation Non-small Cell Lung Cancer | Drug: Sintilimab Combined With Docetaxel Monotherapy<br>* Sintilimab 200mg i.v q3w , Docetaxel 75mg/m2 i.v q3w<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | To measure the patients's overall response rate | Approximately 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival | Approximately 1 years | 
| OS | Overall survival | Approximately 1 years |
Intranasal Insulin for Posttraumatic Stress Disorder

Study Overview
=================
Brief Summary
-----------------
To evaluate if intranasal insulin is effective in reducing PTSD symptoms.

Detailed Description
-----------------
The current proposal aims to study the pharmacotherapeutic effects of intranasal insulin on PTSD symptoms and inhibition of amygdala hyperactivation in subjects with PTSD.

Official Title
-----------------
Intranasal Insulin for Treating Posttraumatic Stress Disorder

Conditions
-----------------
PTSD

Intervention / Treatment
-----------------
* Drug: Intranasal insulin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, 21-65 years old Current PTSD Able to provide written informed consent Exclusion Criteria: Unstable medical condition, clinically determined by a physician Diabetes requiring insulin or oral hypoglycemic agents Moderate-severe traumatic brain injury Current psychotic disorder, bipolar disorder, cognitive disorder in the past 12 months Current substance use disorders (except alcohol, tobacco, or cannabis) in the past 3 months Changes in doses of psychotropic medications in the past 4 weeks Initiation of individual therapy or counseling in the past 4 weeks Imminent suicidal or homicidal risk Contraindication to Insulin History of claustrophobia Presence of cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI safety screening questionnaire

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal insulin<br>Subjects in this arm will receive 40 IU of intranasal insulin twice a day (80 IU per day). | Drug: Intranasal insulin<br>* Subjects in this arm will receive intranasal insulin (80 IU per day).<br>|
| Experimental: Placebo<br>Subjects in this arm will receive placebo. | Drug: Placebo<br>* Subjects in this arm will receive placebo.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-traumatic stress disorder (PTSD) symptoms as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | The five-point CAPS-5 consists of 20 PTSD symptoms rated on a 0-4 scale (total range: 0-80) as follows: (1) 5 Intrusion symptoms (0-20), (2) 2 Avoidance symptoms (0-8), (3) 7 Cognitions and mood symptoms (0-28), and (4) 6 Arousal and reactivity symptoms (0-24). Higher scores represent a worse outcome (i.e., more PTSD symptoms). | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intranasal insulin, PTSD
Work of Breathing and Oxygen Saturation in Infants Receiving High Flow Nasal Cannula (HFNC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare work of breathing on different levels of high flow respiratory support on infants born between 27 and 37 weeks gestation.

Official Title
-----------------
Work of Breathing and Oxygen Saturation Stability in Infants With Respiratory Insufficiency While Receiving Various Flow Rates of High Flow Nasal Cannula

Conditions
-----------------
High Flow Nasal Cannula

Intervention / Treatment
-----------------
* Other: Enrollment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants between 27 and 37 weeks corrected gestational age >4 days PNA Stable (i.e. not meeting exclusion criteria) and receiving non-invasive respiratory support (HFNC) for ≥ 12 hours Requiring ≤ 40% supplemental FiO2 as determined by the clinical care team for clinical care purposes independent of this study Exclusion Criteria: Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of WOB measurements

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

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 |
| --- | --- |
| Enrollment<br> | Other: Enrollment<br>* All infants enrolled will have work of breathing assessed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work of breathing indices | Altering HFNC flow rates and its effect on work of breathing indices in preterm infants with respiratory insufficiency. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intermittent hypoxia | Altering HFNC flow rates and its effect on intermittent hypoxia in preterm infants with respiratory insufficiency. | 2 hours |
Neurobiology of Opioid Dependence: 5 - 5

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of acute naltrexone pretreatment on the response to yohimbine in healthy volunteers.

Official Title
-----------------
Neurobiology of Opioid Dependence: 5

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Naltrexone


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Naltrexone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral, physiological, neuroendocrine response to yohimbine |  |  |
The Effect of Training on Endothelial Function, Progression of Disease,Inflammation, Heart Rate Variability and Mental Health After Percutaneous Coronary Intervention

Study Overview
=================
Brief Summary
-----------------
The Efector study is an open, randomized and controlled trial assessing the effect of regular exercise training on endothelial function, inflammatory markers, progression of disease, heart rate variability and mental health in patients who have been successfully treated with percutaneous coronary intervention and stent implantation for angina pectoris.

Detailed Description
-----------------
Pas er randomized to a 6 months training group or none training. At baseline and at 6 months patients are examined with blood tests to measure serum concentrations of inflammatory markers, a test for endothelial function, heart rate variability and a coronary angiogram. Further patients are asked to answer questionnaires concerning mental health (SF36, HADS).

Official Title
-----------------
Effect of Exercise Training After Percutaneous Coronary Intervention

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Behavioral: exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Successful PCI with stent implantation, Able to participate in the training program, No planned further revascularisation Exclusion Criteria: CAGB, Inflammatory diseases other than CAD, Heart failure, Severe kidney failure, Inability to participate in the training program

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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

| Intervention/Treatment |
| --- |
|Behavioral: exercise training|Exercise training in groups|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flow mediated dilation, serum concentrations of biomarkers, restenosis-rate/ late luminal loss, heart rate variability in SDNN |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen uptake capacity (mg/kg/min), Sf36 scores |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCI, stent, training, endothelial function, restenosis, late luminal loss, heart rate variability, oxygen uptake capacity, inflammatory markers
Open-Label, Long-Term Treatment Study, to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane in Patients With Subjective Tinnitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the long-term safety and tolerability and efficacy of neramexane mesylate in the long-term treatment of subjective tinnitus after a completed double-blind randomized placebo controlled study

Official Title
-----------------
An Open-Label, Long-Term Treatment Study to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane With Subjective Tinnitus

Conditions
-----------------
Subjective Tinnitus

Intervention / Treatment
-----------------
* Drug: Neramexane mesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Male or female patients who have successfully completed one of the double-blind Phase 3 tinnitus studies of Merz with Neramexane mesylate patients aged equal or older 18 but not older than 75 years with clinical diagnosis of first onset, persistent (i.e. tinnitus should never be absent for more than 24 hours in a row), subjective, uni-or bilateral subacute tinnitus at the timepoint of the lead-in study Main Exclusion Criteria: clinical diagnosis of intermittent or pulsatile tinnitus Patients who have tinnitus as a concomitant symptom of an otological/neurological disease (such as otitis media, Meniére´s disease, otosclerosis etc.)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1, verum<br> | Drug: Neramexane mesylate<br>* Up-titration treatment period of 5 weeks up to 75mg Neramexane mesylate oral per day followed by 49 weeks treatment maintenance<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive analyses of TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen 12 Tinnitus Handicap Inventory 12)total score and its subscores, of the Tinnitus Rating Scale and its single items as well as of SF-36 and safety/tolerability parameters |  | 54 weeks |
Predictive Factors of Endoscopic Mucosal Healing in Quiescent Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether fecal calprotectin, fecal immunochemical test, and Rome III criteria for irritable bowel syndrome (IBS) can predict mucosal healing in patients with quiescent ulcerative colitis (UC).

Official Title
-----------------
Predictive Factors of Endoscopic Mucosal Healing in Quiescent Ulcerative Colitis: Prospective Observational Multicenter Study

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Other: colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ulcerative colitis who have no change of medication for at least 6 months Patients with ulcerative colitis who are in remission (Mayo score <3) Patients with ulcerative colitis who will undergo colonoscopy for surveillance or mucosal healing check-up Exclusion Criteria: Patients who refuse to participate Patients who have a history of colectomy Patients who have instinal stricture or perforation

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Quiescent UC<br>Patients with quiscent UC who will undergo colonoscopy for surveillance or mucosal healing check up | Other: colonoscopy<br> <br> * Other names: Rome III criteria for IBS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucosal healing | Endoscopic Mayo subscore <1 | 1 week | 
| Fecal calprotectin |  | 1 week | 
| Fecal immunochemical test |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rome III criteria for IBS |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ulcerative colitis, fecal calprotectin, mucosal healing