linjc16/ctgov huggingface dataset:
Prospective Pain Study Comparing Different Treatments After Hand Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the efficacy of three different types of pain medication (Oxycodone - an opioid, Ibuprofen - a non-steroidal anti-inflammatory, and Acetaminophen - a non-opioid analgesic) in the management of postoperative pain following single soft tissue procedures of the hand and wrist performed exclusively under local anesthesia without sedation. The results of this study will help define optimal prescribing guidelines following the two most common hand surgeries while also potentially validating the use of opioid alternatives post-operatively in order to help mitigate excessive or unnecessary dispensal of opioid analgesics.

Official Title
-----------------
PROSPECTIVE RANDOMIZED CONTROLLED TRIAL COMPARING OXYCODONE, IBUPROFEN AND ACETAMINOPHEN AFTER WIDE AWAKE HAND SURGERY

Conditions
-----------------
Post-operative Pain

Intervention / Treatment
-----------------
* Drug: 5mg of Oxycodone every 6 hours as needed for pain
* Drug: 600mg of Ibuprofen every 6 hours as needed for pain
* Drug: 500mg of Acetaminophen every 6 hours as needed for pain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients indicated to undergo primary, unilateral carpal tunnel release or trigger finger release surgery under local anesthesia alone. Age eligibility is > 18 years of age. Local anesthesia with 1% lidocaine with 1:100,000 epinephrine and Bicarbonate. Exclusion Criteria Bilateral procedures. Additional soft tissue or boney procedures performed simultaneously. The use of sedation and/or general anesthesia. Pediatric patients (age < 18 years). Pregnant female patients. Non-English speaking patients. Known allergies or medical contraindications to Oxycodone, Ibuprofen, Acetaminophen. History of chronic pain and/or narcotic use preoperatively.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Opioid Group<br> | Drug: 5mg of Oxycodone every 6 hours as needed for pain<br>* 5mg of Oxycodone every 6 hours as needed for pain<br>|
| Active Comparator: NSAID group<br> | Drug: 600mg of Ibuprofen every 6 hours as needed for pain<br>* 600mg of Ibuprofen every 6 hours as needed for pain<br>|
| Active Comparator: Acetaminophen<br> | Drug: 500mg of Acetaminophen every 6 hours as needed for pain<br>* 500mg of Acetaminophen every 6 hours as needed for pain<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric rating Scale for Pain | 11-point numeric rating scale (NRS) for pain | 2 weeks post-op |
Hospitalizations in Neonatal Period and Early Discharge of Maternity

Study Overview
=================
Brief Summary
-----------------
in the past 2 decades the number of early discharge of maternity is increasing. The aim of this study is to observe if an early maternity discharge increase the rate of hospitalization during the neonatal period. All infants with maximum 28 days old who are hospitalized at the Hospital center of Nancy: through emergency unit of children's hospital or maternity, through intensive care unit of children's hospital.

Official Title
-----------------
Inventory of Hospitalizations in the Neonatal Period and Validation of the Early Maternity Discharge Protocol: Retrospective Observational Study

Conditions
-----------------
Hospitalization, Neonatal Period, Early Maternity Discharge, Risk Factor Readmission

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infants hospitalized maximum at the aged of 28 days (day 28 included) infants already discharged from maternity infants hospitalized in Hospital Center NANCY: at Children's informed by the study, parents did not refused to participate to the study Exclusion Criteria: more than 28 days old infants transferred from maternity without discharge at home.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 28 Days

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 |
| --- | --- | --- |
| Age at maternity discharge | age in hours at the discharge of maternity | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Etiology of hospitalization | Description of the cause of the hospitalization | 1 month | 
| Jaundice risk factor | different risk factor of jaundice, jaundice and phototherapy | 1 month | 
| Risk factor of early neonatal bacterial infection | mother's and newborn's risk factor to determinate follow up | 1 month | 
| social environment at home, mother's parity | determined the environment of the newborn for a safety maternity discharge | 1 month | 
| pediatrics follow up | the follow up set up at home by the different medical stuff (pediatrician, family doctor, midwife | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early discharge maternity, causes of readmission, neonatal, readmission
Dose Finding Study of KRN125 (Pegfilgrastim) for Treatment of Neutropenic Patients

Study Overview
=================
Brief Summary
-----------------
To assess the duration of severe neutropenia in cycle 1 of chemotherapy after treatment with a single injection of KRN125 or multiple daily injections of filgrastim.

Official Title
-----------------
A Randomized Dose Finding Study of KRN125 (Pegfilgrastim) for the Treatment of Chemotherapy - Induced Neutropenia in Malignant Lymphoma

Conditions
-----------------
Neutropenia

Intervention / Treatment
-----------------
* Drug: pegfilgrastim


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed as malignant lymphoma patients who were refractory to anthracycline or anthraquinone containing chemotherapy patients who are going to receive ESHAP or CHASE treatment regimen ECOG performance status =< 2 patients who have appropriate bone marrow, hepatic and renal functions written informed consent Exclusion Criteria: double cancer history of bone marrow transplantation or PBSCT more than 2 prior chemotherapy regimens primary hematologic disease such as myelodysplastic syndrome previous radiotherapy within 4 weeks of enrollment woman of childbearing potential who were either pregnant, breast feeding patients who participated in other clinical trials within the last 4 weeks of enrollment

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 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: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the duration of severe neutropenia |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pegfilgrastim, neutropenia, cancer patients, lymphoma
The 90% Effective Dose of Nalbuphine in Mechanical Ventilated Patients in the ICU

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the effective nalbuphine dose in 90% of intubated patients in the ICU, including the continuous infusion dose and a bolus dose during moving to the lateral decubitus position. Pain will assessed using a Behavioural Pain Scale (BPS) requiring a score of 3-4.

Detailed Description
-----------------
The continuous nalbuphine infusion dose starts at 100ug/kg/h, if the BPS scores reaches 3-4, the continuous infusion dose would be decreased by 20 ug/kg/h for next patients. If not, increased by 20 ug/kg/h. The nalbuphine bolus is injected 5 min before turning the patients and the dose (starting at 0) is increased by 0.05 mg/kg, prior to each subsequent turn to lateral decubitus until a BPS score of 3-4 is obtained.

Official Title
-----------------
The 90% Effective Dose of Nalbuphine in Mechanical Ventilated Patients in the ICU

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Nalbuphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mechanical invasive ventilation Sedated only with nalbuphine Exclusion Criteria: Pregnant or breast-feeding woman Age below 18 or over 80 years An indication for deep sedation (e.g.the initial stage of septic shock, acute brain injury or acute respiratory distress syndrome) Renal dialysis The inability to assess pain by the BPS scale (e.g. paralysis) BMI less than 18 or more than 35 Preadmission use of opioid analgesic for chronic pain Severe hepatic failure State of consciousness with impossibility to use self-assessment scale; monoamine oxidase inhibitors

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

Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nalbuphine<br> | Drug: Nalbuphine<br>* dosage of nalbuphine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous pumping dose of nalbuphine | The effective continuous infusion dose of nalbuphine to obtain a satisfactory analgesia | 2 days | 
| Nalbuphine bolus dose | The effective dose of a nalbuphine bolus to obtain a satisfactory analgesia | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mechanical ventilation, nalbuphine
Open Label Extension Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder

Study Overview
=================
Brief Summary
-----------------
This extension study is designed to assess the long-tem tolerability and safety of licarbazepine in patients who completed the 6-week double-blind study CLIC477D2303.

Official Title
-----------------
A 52-week, Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: licarbazepine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent provided prior to participation in the extension study successful completion of study CLIC477D2303 cooperation and willingness to comply with all study requirements Exclusion Criteria: premature discontinuation from study CLIC477D2303 failure to comply with study CLIC477D2303

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: licarbazepine<br> | Drug: licarbazepine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of treatment with licarbazepine over 52 weeks. |  |  | 
| with respect to the rates of adverse events and serious adverse events, as well as changes in laboratory values, ECGs and vital signs. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar disorder, manic episode/treatment/licarbazepine
Is This PJI Really Acute: A Quantitative Sonication Fluid Analysis (Sonic)

Study Overview
=================
Brief Summary
-----------------
This retrospective study is to analyse microbiological cultures from the sonication fluid of the explanted prothesis to detect bacteria in the biofilm on the implant surface and to investigate whether the number of bacteria in the biofilm correlates with the duration of the PJI respectively with the period between symptom onset and date of revision surgery.

Detailed Description
-----------------
Implant associated infections in orthopaedics and trauma surgery are a well-known and feared complication. Prosthetic-joint infection (PJI) is caused by a biofilm which is located atop the surface of the implant which as growing with the duration of the PJI. This retrospective study is to analyse microbiological cultures from the sonication fluid of the explanted prothesis to detect bacteria in the biofilm on the implant surface and to investigate whether the number of bacteria in the biofilm correlates with the duration of the PJI respectively with the period between symptom onset and date of revision surgery.

Official Title
-----------------
Is This PJI Really Acute: A Quantitative Sonication Fluid Analysis

Conditions
-----------------
Prosthetic-joint Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who underwent a revision surgery of hip, knee and shoulder arthroplasties operated at the university hospital of Basel between 2011 and 2021, patients who had a PJI as a suspected diagnosis and have microbiological cultures from sonication fluid from removed prosthesis. Exclusion Criteria: patients in the database who have non-bacterial microbiological positive cultures (e.g. fungal infection) and have not received a sonication of the removed prosthesis during the diagnostic process

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| number of bacteria | number of bacteria detected during revision surgery will be taken from the sonication fluid and the quantitative analysis of the microbiological samples | one time assessment at baseline | 
| duration of the infection | duration of the infection | one time assessment at baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
debridement, antibiotics and implant retention (DAIR), sonication fluid analysis
Amlodipine Diabetic Hypertension Efficacy Response Trial

Study Overview
=================
Brief Summary
-----------------
To evaluate the percentage of subjects that reach the diabetic hypertensive blood pressure goal of <130/80 with amlodipine versus placebo in subjects initially treated with quinapril or losartan.

Official Title
-----------------
A Multi-Center, Randomized, Double-Blind, Double-Dummy Study Evaluating The Safety and Efficacy Of The Addition Of Amlodipine To Quinapril Or Losartan In The Treatment Of Diabetic Hypertensive Subjects

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Amlodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented evidence of Type 2 diabetes as defined by the ADA guidelines and documented evidence of Hypertension (various SBP/DBP ranges). Exclusion Criteria: A previous history or intolerance or hypersensitivity to calcium channel blockers, ARBs or ACE inhibitors.

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of subjects that reach the JNC diabetic hypertensive BP goal of <130/80 will be assessed at Week 0 (Visit 2-Randomization), Week 5 (Visit 3), Week 9 (Visit 4), Week 15 (Visit 5) and Week 20 (Visit 6 - Final Evaluation). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects at SBP goal of <130 mmHg and DBP goal of <80mmHg; change from baseline blood pressures (SBP and DBP); percentage of subjects with SBP >160mmHg and/or DBP >100mmHg at Visits 2, 3, 4, 5, 6. |  |  |
Efficacy of Gevokizumab in the Treatment of Patients With Behçet's Disease Uveitis (EYEGUARD™-B)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to demonstrate the superiority of gevokizumab as compared to placebo on top of current standard of care in reducing the risk of Behçet's disease uveitis exacerbations

Detailed Description
-----------------
A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitis

Official Title
-----------------
A Randomized, Double-masked, Placebo-controlled Study of the Efficacy of Gevokizumab in the Treatment of Patients With Behçet's Disease Uveitis

Conditions
-----------------
Behcet's Uveitis

Intervention / Treatment
-----------------
* Drug: Gevokizumab
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Behçet's disease diagnosis fulfilling the International Study Group Classification Criteria. History of Behçet's disease uveitis with ocular involvement of the posterior segment. Patients with a stable background treatment of oral corticosteroid and at least one immunosuppressive drug. Male or female, age ≥18 (or legal age of majority in the country) at selection For subjects with reproductive potential, a willingness to use highly effective contraceptive measures Exclusion Criteria: Infectious uveitis, uveitis due to causes other than Behçet's disease. Monocular vision Presence of severe cataract or severe posterior capsular opacification. Contraindication to mydriasis or presence of posterior synechiae. Active TB disease. History of severe allergic or anaphylactic reactions to monoclonal antibodies History of malignancy within 5 years prior to Selection. Other protocol-defined inclusion/exclusion criteria may apply

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gevokizumab<br>Solution for subcutaneous injection, Dose 1 | Drug: Gevokizumab<br>* Sterile solution administered subcutaneously<br>|
| Placebo Comparator: Placebo<br>Solution for subcutaneous injection, placebo | Drug: Placebo<br>* Sterile solution administered subcutaneously<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first acute ocular exacerbation | number of days | up to 3 years |
Novel Equation for Estimating Intraperitoneal Pressure

Study Overview
=================
Brief Summary
-----------------
Intraperitoneal Pressure is associated with the complications of increased intra-abdominal pressure in peritoneal dialysis patients. Due to the complicated operations, routine measurement of hydrostatic intraperitoneal pressure is not used routinely in adult peritoneal dialysis patients. There ars some limitions in equations from previous studies, such as the sample size was small , and the study population was limited. In the study, we aim to develop and validate an equation for estimating intraperitoneal pressure in peritoneal patients.

Official Title
-----------------
Novel Equation for Estimating Intraperitoneal Pressure in Patients on Peritoneal Dialysis Patients

Conditions
-----------------
Intraperitoneal Pressure, Peritoneal Dialysis, Equation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Peritoneal dialysis patients Dialysis length >1 month Aged 18-80 years Injection volume of peritoneal dialysis solution>1500ml Exclusion Criteria: Acute complications （ peritonities, cardiovascular and cerebrovascular diseases) to hospitalization 1 month prior to the study History of abdominal surgery and trauma 1 month prior to the study Previous history of hernia, leakage, or thoracoabdominal fistula Can't come for a follow-up visit

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Novel equation development | Developed equation for estimating intraperitoneal pressure in peritoneal dialysis patients | July 17, 2021 to September 30, 2021 | 
| Novel equation validation | Validate the novel equation with intraperitoneal pressure obtained by Durand method | October 1,2021 to October 31,2021 |