linjc16/ctgov huggingface dataset:
Methods for Effective Disposal of Surplus Analgesics to Facilitate Elimination

Study Overview
=================
Brief Summary
-----------------
The primary objective is to evaluate the difference in outcomes for mail-in vs. in-home disposal methods for leftover prescription opioids after discharge from surgery.

Official Title
-----------------
Methods for Effective Disposal of Surplus Analgesics to Facilitate Elimination

Conditions
-----------------
Surgery, Analgesics, Opioids

Intervention / Treatment
-----------------
* Other: In-home drug disposal pouch
* Other: Mail-in prepaid envelope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anticipated to be prescribed and use an opioid medication to treat acute pain after elective outpatient surgery Opioid-naive Exclusion Criteria: Inability to receive email and/or phone calls for follow up assessment

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: In-home<br> | Other: In-home drug disposal pouch<br>* Will receive a drug disposal pouch to inactivate leftover prescription opioids for disposal after surgery.<br>|
| Active Comparator: Mail-in<br> | Other: Mail-in prepaid envelope<br>* Will receive a prepaid envelope to mail leftover prescription opioids for disposal after surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of assigned disposal method | Among patients who have leftover opioids, patient report of the use of their assigned mail-in or in-home method of disposal by 2 weeks after surgery. | 2 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of safe disposal method | Patient-reported use of a method for disposal of leftover opioids that includes mail-in, in-home, pharmacy drop off, or flushing down the toilet by | 2 weeks after surgery | 
| Use of any disposal method | Patient-reported use of any method to dispose of leftover opioids, that includes assigned methods, safe methods, and other methods such as placing in the trash | 2 weeks after surgery | 
| Feasibility of Intervention Measure (FIM) |  | 2 weeks after surgery | 
| Acceptability of Intervention Measure (AIM) |  | 2 weeks after surgery | 
| Patient-Reported Satisfaction with Use of Disposal Method (study derived question) | Patient report of overall satisfaction with use of the assigned disposal method, on a 0 (worst) to 10 (best) numeric scale | 2 weeks after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Opioids, Drug disposal
AMNIOmics: A Prenatal Rapid Genome Validation Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate Whole Genome Sequencing (WGS) on amniotic fluid to reduce the time to diagnosis and enhance the care for the fetus/neonate.

Official Title
-----------------
AMNIOmics: A Prenatal Rapid Genome Validation Study

Conditions
-----------------
Multiple Anomalies of Fetus, Genetic Predisposition Suspected, Amniocentesis Affecting Fetus or Newborn, Family Members

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Fetus with multiple anomalies/suspected genetic disease. Pregnant patient already planning on having an amniocentesis for another reason separate from this study. Exclusion Criteria Parents under the age of 18. Parents lacking the capacity to consent. Institutionalized (i.e., Federal Medical Prison).
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 |
| --- | --- | --- |
| Validation of Rapid Whole Genome Sequencing technology on amniotic fluid samples | Collection of both amniotic fluid and blood samples to compare results of whole genome sequencing for a fetus with suspected genetic disease. | 5 years | 
| Enrollment of study participants | To recruit up to 90 total participants including child and both parents | 5 years | 
| Collection of Biospecimens | Total number of biospecimens collected which may include both blood samples and amniotic fluid | 5 years |
Pilot Trial of Supplemental Vitamin A and Nicotinamide

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to assess the feasibility and safety of oral nicotinamide (NAM; a derivative of vitamin B3 [niacin]) and vitamin A in a high-risk population of kidney transplant recipients with a history of skin cancer to generate preliminary data for future cancer prevention clinical trials.

Official Title
-----------------
Pilot Trial of Supplemental Vitamin A and Nicotinamide and Levels of Blood Vitamin A and Nicotinamide

Conditions
-----------------
Skin Cancer, Kidney Transplant Recipients

Intervention / Treatment
-----------------
* Drug: Vitamin A
* Drug: Nicotinamide
* Other: Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old or greater; Either History of 2 or more histologically confirmed invasive cutaneous SCCs in the past 2 years or At least one previously billed Healthcare Common Procedure Coding System code 17004 (destruction of 15 or more benign or premalignant lesions of the integumentary system); Understands, reads, and writes English proficiently. Exclusion Criteria: Liver disease; Active peptic ulcer disease; Recent myocardial infarction; Hypotension; Internal malignancy within past 5 years; Renal impairment with eGFR<15 mL/min/1.73 m2; Being unable for follow up due to social reasons; Gorlin's syndrome or other genetic skin cancer syndrome; Huge number of current skin cancers; Metastatic SCC or invasive melanoma within the past 5 years; Pregnancy or lactation; Need for ongoing carbamazepine use (which could have a possible interaction with NAM); Use of acitretin or other oral retinoids within the past 6 months; Use of supplemental NAM, niacin, vitamin A, or beta carotene within the past 6 months; Field treatment for actinic keratoses (AKs) within the previous 4 weeks; Use of topical steroids.

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin A & Nicotinamide<br>1,000 μg retinyl palmitate and 500 mg NAM twice a day | Drug: Vitamin A<br>* 1,000 μg retinyl palmitate twice a day for 6 months<br>Drug: Nicotinamide<br>* 500 mg NAM twice a day for 6 months<br>* Other names: Niacin (Vitamin B3);|
| Placebo Comparator: Placebo<br>Identical placebo pills twice a day | Other: Other: Placebo<br>* Identical placebo pills twice a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Blood Vitamin A and Nicotinamide Levels |  | 6 months |
Drug-eluting Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis--a Multicenter Study

Study Overview
=================
Brief Summary
-----------------
The study will test the efficacy of drug eluting balloon(DEB) for non-atherosclerotic renal artery stenosis. The DEB (paclitaxel eluting balloon) will be used in the intervention group, while the plain old balloon(POB) will be used in the control group. The primary outcome is the effect of blood pressure control.

Official Title
-----------------
Comparison of Drug Eluting Balloon and Plain Old Balloon for the Treatment of Non-atherosclerotic Renal Artery Stenosis--A Protocol of a Multicenter Study

Conditions
-----------------
Hypertension, Renovascular

Intervention / Treatment
-----------------
* Procedure: Parallel Assignment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18y and 45y. with ≥ 60% stenosis in at least one renal artery. with hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg). patients with no severe renal insufficiency (eGFR>30 ml/min, length of the kidney ≥ 7cm). Good compliance. with informed consent. Exclusion Criteria: With apparent atherosclerotic risk factors. With renal intervention or surgery history. With congenital anatomical anomaly. With severe renal insufficiency (length of the target kidney < 7cm, total eGFR<30ml/min, divided eGFR of the target kidney<8 ml/min) With contraindication for antiplatelet therapy. With severe cardiopulmonary insufficiency. Allergic to contrast medium Being pregnant or preparing for pregnancy With active cancer. Life expectancy < 12 month Without informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DEB group<br>paclitaxel-coated balloon (Orchid, Acotec Scientific Holdings Limited, Beijing, China) | Procedure: Parallel Assignment<br>* intervention group: treated with drug eluting balloon（paclitaxel-coated balloon； Orchid, Acotec Scientific Holdings Limited, Beijing, China)； control group :treated with plain old balloon<br>|
| Placebo Comparator: POB group<br> | Procedure: Parallel Assignment<br>* intervention group: treated with drug eluting balloon（paclitaxel-coated balloon； Orchid, Acotec Scientific Holdings Limited, Beijing, China)； control group :treated with plain old balloon<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency rate | uninterrupted patency with no procedures performed on or at the margins of the treated segment or bypass | 9 months |
Management of Slipped Capital Femoral Epiphysis (SCFE) on Top of Fixed Fracture Neck of Femur Case Report.

Study Overview
=================
Brief Summary
-----------------
Slipped Capital Femoral Epiphysis (SCFE) on Top of Fixed Fracture Neck of Femur managed by subtrochanteric valgus osteotomy

Detailed Description
-----------------
The incidence of Slipped capital femoral epiphysis (SCFE) after management of femoral neck fracture in pediatrics is very rare. In this case report, a 9-year-old female child sustained left sided femur neck fracture after a motor car accident. The fracture was fixed by two cannulated screws and healing with mild varus occurred after 1.5 months. However, progressive slippage of femoral epiphysis was observed. This was treated by subtrochanteric valgus osteotomy

Official Title
-----------------
Management of Slipped Capital Femoral Epiphysis (SCFE) on Top of Fixed Fracture Neck of Femur Case Report.

Conditions
-----------------
Slipped Capital Femoral Epiphysis

Intervention / Treatment
-----------------
* Procedure: subtrochanteric valgus osteotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scfe on top NOF Exclusion Criteria: pathological fracture

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: subtrochanteric valgus osteotomy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: subtrochanteric valgus osteotomy<br>subtrochanteric valgus osteotomy | Procedure: subtrochanteric valgus osteotomy<br>* subtrochanteric valgus osteotomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified McKay's criteria | I excellent II Good III Fair IV Poor | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rust union score | union absent callus visible fracture present callus visible fracture present callus invisible fracture | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Slipped capital femoral epiphysis, SCFE, coxa vara, fracture neck of femur
Orthosis to Improve Trunk Control in Infants Age 6-18 Months

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the impact of the SPIO® Core-MAX® Expedition orthosis on an infant's head, trunk and upper limb function.

Detailed Description
-----------------
This study will observe the difference in outcomes between two courses of standard clinical care: therapy or therapy with the SPIO® Core-MAX® Expedition orthosis. Families will self-select that standard care option that works best for their family, and outcomes will be observed at baseline, 3 months and 6 months.

Official Title
-----------------
Assessing Functional Improvements With Use of the SPIO Core-Max Expedition TLSO

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Device: SPIO® Core-MAX® Expedition thoracolumbosacral orthosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study subjects aged 6 months to 18 months age corrected with abnormal muscle tone No previous use of SPIO® or similar Lycra/compression garments Assessed by provider as likely to benefit from use of compression garment Exclusion Criteria: Non-English speaking Inability for family to bring study subject to assessments Orthosis or casting that contraindicate SPIO® Core-MAX® during the study period Botulinum toxin injections within 3 months, or during study participation Having prior orthopedic or neurosurgery surgeries within one year

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 18 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 |
| --- | --- |
| SPIO group<br>Standard Care Therapy option 1: parents may self-select this standard care combined option of therapy and use of SPIO® Core-MAX® Expedition thoracolumbosacral orthosis | Device: SPIO® Core-MAX® Expedition thoracolumbosacral orthosis<br>* SPIO® Core-MAX® Expedition thoracolumbosacral orthosis use 2 hours per day for 6 months<br>|
| Control group<br>Standard Care Therapy option 2: parents may self-select this standard care option of therapy alone | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in head and trunk position from centerline at baseline, 3-months and 6-months. |  | Through study completion, an average of 2 years | 
| Change from baseline to 3-months and 6-months on the Pediatric Quality of Life Inventory Infant Scale. |  | Through study completion, an average of 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abnormal muscle tone, cerebral palsy, hypotonia, muscle tone, spasticity
Evaluation of the Analgesic Efficacy of Multimodal Pain Control Regimens That Aim to Limit the Use of Narcotics in Cholecystectomy and Hernia Repairs

Study Overview
=================
Brief Summary
-----------------
Subjects were patients of the five surgeons with Surgical Associates of Mansfield (SAM) who underwent an elective or urgent laparoscopic cholecystectomy; or elective or urgent laparoscopic or open hernia repair (inguinal, ventral, or umbilical); and who otherwise met the inclusion criteria. I

Detailed Description
-----------------
This performance improvement study is a retrospective review of data obtained from patients at Methodist Mansfield Medical Center (MMMC) in Mansfield, Texas from May 1, 2022 to September 30, 2022. Subjects were patients of the five surgeons with Surgical Associates of Mansfield (SAM) who underwent an elective or urgent laparoscopic cholecystectomy; or elective or urgent laparoscopic or open hernia repair (inguinal, ventral, or umbilical); and who otherwise met the inclusion criteria. Incisional hernias were excluded. Emergent hernia operations that required bowel or colon resections due to strangulation were excluded

Official Title
-----------------
Evaluation of the Analgesic Efficacy of Multimodal Pain Control Regimens That Aim to Limit the Use of Narcotics in Cholecystectomy and Hernia Repairs

Conditions
-----------------
Acute Pain

Intervention / Treatment
-----------------
* Other: Pain control regimens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of the five physicians of the SAM group Patients ≥18 years Patients undergoing urgent or elective laparoscopic and robotic cholecystectomy OR patients undergoing urgent or elective laparoscopic, robotic or open hernia repair (ventral, umbilical, or inguinal). Exclusion Criteria: Patients <18 years Patients with chronic pain conditions managed with chronic use of narcotics Patients that underwent incisional hernia repairs Patients that underwent complicated hernia repairs that included other operations such as colon and bowel resection procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Pain control regimens|Narcotics in cholecystectomy and hernia repairs|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotics Doses and timeframe | number of doses of narcotics taken including the number of times refilled. | 4 months |
Phase 4 Study Evaluating the Safety of the Nasal Guide With Tyrvaya

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine the safety of the nasal guide when utilized to aid in the administration of Tyrvaya (varenicline solution 0.03mg) Nasal Spray

Detailed Description
-----------------
Protocol OPP-009 is a single center, open-label study to evaluate the safety of the nasal guide during administration of Tyrvaya (varenicline solution 0.03mg) Nasal Spray. Approximately 30 subjects at least 18 years of age will be enrolled at one clinical study site and will receive the nasal guide for use with the administration of Tyrvaya for 7 days.

Official Title
-----------------
A Phase 4, Single Center, Open Label Study Evaluating the Safety of the Nasal Guide Utilized During Administration With Tyrvaya

Conditions
-----------------
Dry Eye, Keratoconjunctivitis Sicca

Intervention / Treatment
-----------------
* Combination Product: Nasal Guide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 18 years of age Have provided verbal and written informed consent Willing to comply with all study related visits and procedures Exclusion Criteria: None

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
Interventional Model Description: Nasal guide will be used to aid in the administration of Tyrvaya® (varenicline solution 0.03 mg) Nasal Spray
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nasal Guide<br>Use of Nasal Guide with administration of Tyrvaya (varenicline solution 0.03 mg) BID | Combination Product: Nasal Guide<br>* Use of Nasal Guide with administration of Tyrvaya (varenicline solution 0.03 mg) BID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events | Adverse Events with use of the nasal guide | 7 days |