linjc16/ctgov huggingface dataset:
Patient-reported Outcomes of Postsurgical Pain and Health Related Quality of Life

Study Overview
=================
Brief Summary
-----------------
This study will investigate the impact of post-surgical pain (PSP) on health related quality of life (HRQoL) within the first six months following surgery using patient-reported outcome (PRO) measures, and to investigate medical recovery measures such as ambulation and oral feeding time as secondary outcomes.

Detailed Description
-----------------
Pain and recovery after surgery are extremely concerned by patients undergoing surgery. Though it is important to understand the recovery course of postsurgical pain and recovery, most previous studies just focused on one specific time point, and the results were inconsistent. To investigate the impact of PSP on HRQoL within the first six months following surgery using PRO measures, patients undergoing several specific surgeries will be interviewed. Patients' medical charts will be reviewed by investigators to record sociodemographic and clinical data.

Official Title
-----------------
Patient-reported Outcomes of Postsurgical Pain and Health Related Quality of Life, a Multi-centered, Prospective, Observational, Cohort Study

Conditions
-----------------
Post Surgical Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Undergoing general or regional anesthesia Hospitalized for at least 24 hours after surgery Exclusion Criteria: Existing diagnoses of psychiatric pathology Surgery cancellation Unable to give informed consent Unable to read and write

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 |
| --- | --- | --- |
| Health related quality of life(HRQoL) | HRQoL is measured with EuroQol five-dimensional questionnaire(EQ-5D). | up to 6 months after surgery | 
| Pain after surgery | Postsurgical pain is measured with the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) . | up to 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ambulation time | the first time when patients can get off of bed and walk after surgery | up to 30 days after surgery | 
| oral feeding time | the first time when patients begin oral feeding after surgery | up to 30 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post-surgical pain, health-related quality of life
Comparison of Two NN1250 Formulations in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This trial was conducted in North America. The aim of this clinical trial was to investigate if two formulations of NN1250 (insulin degludec) have the same level of drug exposure to the body.

Official Title
-----------------
A Trial to Test for Bioequivalence Between Two NN1250 Formulations in Healthy Subjects

Conditions
-----------------
Diabetes, Healthy

Intervention / Treatment
-----------------
* Drug: insulin degludec
* Drug: insulin degludec


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Considered generally healthy upon completion of medical history, physical examination, vital signs and ECG (electrocardiogram), as judged by the Investigator Body mass index 18.0-27.0 kg/m^2 (both inclusive) Exclusion Criteria: Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDeg E<br> | Drug: insulin degludec<br>* Single dose of NN1250, formulation 1, 0.4U/kg body weight injected subcutaneously (under the skin)<br>|
| Experimental: IDeg M<br> | Drug: insulin degludec<br>* Single dose of NN1250, formulation 2, 0.4U/kg body weight injected subcutaneously (under the skin)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the Insulin Degludec concentration-time curve from 0 to 120 hours after single dose |  | From 0 to 120 hours after dosing | 
| Maximum observed Insulin Degludec concentration after single dose |  | From 0 to 120 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to maximum observed Insulin Degludec concentration after single dose |  | From 0 to 120 hours after dosing | 
| Area under the Insulin Degludec concentration-time curve from 0 to 24 hours after single dose |  | From 0-24 hours after dosing | 
| Terminal half-life for Insulin Degludec |  | From 0 to 120 hours after dosing |
OCT Guided Punctal Stenosis Management

Study Overview
=================
Brief Summary
-----------------
This is a clinical trial study that was conducted on patients with punctal stenosis.We studied the diameter of stenosed puncta before and after treatment with preserved free steroid eye drops using AS-OCT.

Detailed Description
-----------------
The study was conducted on 40 eyes of 24 patients have acquired inflammatory punctal stenosis and 20 eyes of 10 patients of normal asymptomatic subjects as control group. We studied the external punctal diameter, visibility of the internal punctum and punctal depth before treatment using AS-OCT, and then patients were re-evaluated after one month of treatment with preservative free methylprednisolone 5% eye drops.

Official Title
-----------------
The Role of Anterior Segment Optical Coherence Tomography in Management of Acquired Punctal Stenosis

Conditions
-----------------
Epiphora Due to Insufficient Drainage

Intervention / Treatment
-----------------
* Drug: Methylprednisolone eyedrops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients have acquired inflammatory punctum stenosis complaining of epiphora of different etiologies. Exclusion Criteria: Previous lacrimal surgery. Lid margin malposition such as ectropion, entropion or lid retraction. Medial lid masses obscuring punctum. History of ocular trauma involving lid margin or punctum.

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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Methylprednisolone eye drops<br>Preservative free steroids methylprednisolone 5% eye drops (prepared by dilution of methyleprednisolone 500mg in 10 ml distilled water (Solu-Medrol, Pfizer company) was prepared and given for all enrolled cases by the following regimen 5 times/day for 5 days with gradual decrease every third day over the following 2 weeks | Drug: Methylprednisolone eyedrops<br>* instillation of methylprednisolone eye drops<br>|
| Placebo Comparator: distilled water eyedrops<br>Distilled water eyedrops instilled 3 times per day for two weeks | Drug: Methylprednisolone eyedrops<br>* instillation of methylprednisolone eye drops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| punctal opening | evaluation of punctalopening by OCT | one month |
Clinical Pharmacokinetics Study on Pikamilone

Study Overview
=================
Brief Summary
-----------------
Study on the phamacokinetics of Pikamilone in healthy Chinese subject and provide informations for further phase II study.

Official Title
-----------------
Clinical Pharmacokinetics Study on Pikamilone

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nonsmokers and in good health weight: BMI: 19-24 written informed consent was finished. Exclusion Criteria: disease taking any drug, alcohol, foods containing caffeine, or grapefruits and juice before study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| pikamilone<br> | |
| dosage<br>low dosage group: administrate pikamilone tablet 50 mg; middle dosage group: administrate pikamilone tablet 100 mg; hige dosage group: administrate pikamilone tablet 200 mg. | |
| tablet<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Changes of NLF in Serum of Long COVID Patients

Study Overview
=================
Brief Summary
-----------------
The study investigates the blood NFL levels in Long-COVID patients.

Detailed Description
-----------------
The study investigates the blood NFL levels in Long-COVID patients.

Official Title
-----------------
Changes of NLF in Serum of Long COVID Patients

Conditions
-----------------
Clinical Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: Bloot testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Long-COVID Syndrom

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LONGCOVID<br>Patient with Long-COVID Syndrom | Diagnostic Test: Bloot testing<br>* NFL measruments in serum<br>|
| CONTROLS<br>Healthy individials | Diagnostic Test: Bloot testing<br>* NFL measruments in serum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of NFL over a 1 year course of the Long-COVID Syndrom | see above | 1 year |
Text-Enabled Ascertainment and Community Linkage for Health

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to pilot test a novel tool for health related social needs screening and linkage to community resources in the ED by randomizing participants to standard handout v. handout + text message with resource information.

Official Title
-----------------
Text-Enabled Ascertainment and Community Linkage for Health

Conditions
-----------------
Emergency Medicine

Intervention / Treatment
-----------------
* Other: Text message information


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 51 ZIP codes included in our database of community resources (catchment area) >=18 years old plan for discharge home speak either English or Spanish live within the catchment area for the study have a cellphone with text messaging capabilities ability to respond to text messages from the study team. Exclusion Criteria: Patients who are intoxicated on a Section 12 lack capacity to consent will be excluded.

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Handout<br>Participants receive a generic handout about resources in Boston | |
| Experimental: Text message<br>Participants receive a generic handout about resources in Boston and a text message with a geographically proximate resource | Other: Text message information<br>* Geographically proximate resources delivered by text message<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction: Likert scale | Participants will be asked about their satisfaction with the program measured on a Likart scale. Options will include Extremely or Quite a bit; Somewhat; A little bit or Not at all | 3-5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resource use | Participants will be asked about actual and planned resource use | 3-5 days | 
| Health status | Participants will be asked about health status. In general, how would you rate your health? Excellent, Very good, Good or Fair,Poor | 3-5 days |
Risk Factors for Piperacillin/Tazobactam Resistance in Extended-Spectrum Beta-Lactamase (ESBL) Producing Organisms

Study Overview
=================
Brief Summary
-----------------
This research will be conducted to determine whether risk factors exist for piperacillin/tazobactam resistance in ESBL organisms.

Detailed Description
-----------------
This is chart review at UPMC. NO human subject interaction will occur.

Official Title
-----------------
Risk Factors for Piperacillin/Tazobactam Resistance in Extended-Spectrum Beta-Lactamase (ESBL) Producing Organisms

Conditions
-----------------
Enterobacteriaceae Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical information is collected by chart review of case and control patients. A case A patient is defined as follows: One or more clinical cultures are positive for an ESBL producing bacteria and the organism is piperacillin/tazobactam resistant. A case B patient is defined as follows: One or more clinical cultures are positive for an ESBL producing bacteria and the organism is piperacillin/tazobactam susceptible. Additionally, 1 control patient in the hospital at the same time as the case patients will be randomly selected for each case and are not in either case group. Exclusion Criteria: Patients < 18 years of age

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 |
| --- | --- | --- |
| This research will help to identify risk factors for resistance to an antibiotic that is commonly used in the empiric treatment of critically ill patients. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ESBL positive cultures
Ketamine- Propofol Versus Pethidine- Propofol in ERCP

Study Overview
=================
Brief Summary
-----------------
The investigators aim to investigate the differences between ketamine propofol and pethidine propofol during ERCP in respect to endoscopist satisfaction.

Detailed Description
-----------------
The investigators aim to investigate the differences between ketamine propofol and pethidine propofol during ERCP in respect to endoscopist satisfaction, amount of propofol consumption Any desaturation or apnea will be recorded when the oxygen saturation (SpO2) dropped to <90% , time for recovery ,post-operative nausea and vomiting, hallucinations and Ramsey sedation scores of all patients will be recorded perioperatively. The Aldrete score was used to measure recovery from anesthesia at 5 and 10 min after the procedure.

Official Title
-----------------
Ketamine-propofol Versus Pethidine-propofol for Sedating Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP)

Conditions
-----------------
Sedation in ERCP

Intervention / Treatment
-----------------
* Drug: ketamine- propofol
* Drug: pethidine- propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: both gender age between 18-70 Exclusion Criteria: pregnant patients. morbid obesity. chronic obstructive pulmonary disease. complicated airway. American society of anesthesia (ASA) physical classification IV-V. history of allergy or contraindications to the drugs used in the study emergency need for ERCP. those whose informed consent could not be signed. those with possible complex ERCP.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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: ketamine- propofol<br>IV Ketamine 1mg/kg + Propofol 1.2 mg/kg will be given for sedation. | Drug: ketamine- propofol<br>* 1 mg x kg(-1) ketamine + 1.2 mg x kg(-1) propofol.<br>* Other names: N01AX03 - Propofol;|
| Active Comparator: pethidine- propofol<br>1.1 mg x kg(-1) pethidine + 1.2 mg x kg(-1) propofol for sedation induction | Drug: pethidine- propofol<br>* 1.1 mg x kg(-1) pethidine + 1.2 mg x kg(-1) propofol for sedation induction<br>* Other names: meperidine - Propofol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endoscopist satisfaction using 5 step scale (5= optimal condition; 1= poor condition) |  | Immediately after procedure. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ketamine, propofol, pethidine, ERCP, endoscopist
Cannabis and Parkinson's Disease Tremor: A Natural History Study

Study Overview
=================
Brief Summary
-----------------
This is a prospective, observational study designed to describe the effects of Cannabis on Parkinson's Disease tremor.

Detailed Description
-----------------
Ten individuals with Parkinson's disease (PD) and tremor who use Cannabis were observed for two weeks. Individuals were asked to keep a journal of Cannabis use (form, delivery method, amount) and wear an accelerometer on the wrist with the dominant tremor. Analyses will be performed to describe whether Cannabis use affects PD tremor following use.

Official Title
-----------------
Cannabis and Parkinson's Disease Tremor: A Natural History Study

Conditions
-----------------
Parkinson's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Parkinson's Disease Presence of PD-related tremor Currently using Cannabis for management of tremor Obtaining Cannabis in accordance with Washington State law Willing to log activities and experiences Willing to wear a motion sensor Able to attend 2 on-site visits Exclusion Criteria: Presence of active infection within 5 days prior to enrollment Presence of unusual stressor within 5 days prior to enrollment Pregnancy

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 |
| --- | --- | --- |
| Percent reduction in tremor as measured by Opal movement sensor |  | Upon enrollment, ongoing for 14 days |
A Study to Evaluate the Potential for Interpersonal Transfer of Testosterone Following Single Dose Application

Study Overview
=================
Brief Summary
-----------------
The hypotheses for this study is that there is no transfer of testosterone from male (donor) subjects to female (recipient) subjects when contact is made 2 hours post application of 2% Testosterone MD-Lotion® if the donor has a covered application area with a T-shirt.

Official Title
-----------------
A Phase I Study to Evaluate the Potential for Interpersonal Transfer of Testosterone Following Single Dose Application of 2% Testosterone Metered Dose (MD) Lotion®

Conditions
-----------------
Hypogonadism

Participation Criteria
=================
Eligibility Criteria
-----------------
Healthy Male Subjects: Inclusion: Healthy male subjects aged ≥ 18 and ≤ 45, who have no history of clinically significant medical disorders and who have passed the required laboratory and physical screening tests. Exclusion: Men with a history of allergy/sensitivity to testosterone or in whom testosterone therapy is contraindicated, or a clinically significant finding on physical exam or skin disorder. Healthy Female Subjects: Inclusion: Healthy premenopausal women aged ≥ 18 and ≤ 45, who have no history of clinically significant medical disorders and who have passed the required laboratory and physical screening tests. Exclusion: Women with a history of allergy/sensitivity to testosterone or in whom testosterone therapy is contraindicated, or a clinically significant finding on physical exam or skin disorder.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | Single dose pharmacokinetic parameters (AUC0-24, AUC0-72, Cmin, Cmax, and tmax) are to be reported for total testosterone, free testosterone and DHT. | 72 hours total | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open label, single dose, pharmacokinetic study