linjc16/ctgov huggingface dataset:
Efficacy Trial of Oral Tetrahydrocannabinol in Patients With Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluate the effectiveness of oral tetrahydrocannabinol in patients suffering from Fibromyalgia

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled Trial of Oral Tetrahydrocannabinol (∆-9-THC) in Patients With Fibromyalgia

Conditions
-----------------
Fibromyalgia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Adult (>18y.o) Patient with Fibromyalgia, diagnosed by ACR criteria Exclusion Criteria: - Children < 18 years old Patients with following psychiatric disorders: Psychosis or history of acute psychosis Schizophrenia Bipolar disorder Patients smoking marijuana, using hashish or any other form of cannabis. Patients with history of drug abuse or illicit drug use Patients receiving chronic treatment with strong opioids (Morphine, Oxycodone, Fentanyl, Methadone, Hydromorphone, Buprenorphine, Pethidine). Weak opioids as Tramadol or Propoxyphene will be allowed. Pregnant patients

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: Tetrahydrocannabinol<br> | Drug: Tetrahydrocannabinol<br>* Oral solution of THC in concentration of 5mg/0.2ml. Dose regimen: 5mg 2-4 times/day as tolerated.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Orally administered olive oil. Dose: 0.2ml 2-4 times a day as tolerated<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meaningful change in Total score on Fibromyalgia Impact Questionnaire (FIQ) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meaningful change in Brief Pain Inventory average pain severity. |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibromyalgia, Tetrahydrocannabinol, Chronic Widespread Pain
Hygiene Protocol of Complete Dentures

Study Overview
=================
Brief Summary
-----------------
Adequate denture hygiene is important to patient's oral health maintenance in particular because of Candida albicans, responsible for the development of denture stomatitis. The aim of this study is to conduct a randomized controlled trial seeking for the best hygiene protocols to be used in removable denture wearers. The null hypothesis tested is that there will be no difference among the denture hygiene protocols tested.

Official Title
-----------------
Hygiene Protocols for Cleaning Complete Dentures

Conditions
-----------------
Denture Hygiene Protocol

Intervention / Treatment
-----------------
* Other: water
* Other: sodium hypochlorite
* Other: sodium bicarbonate
* Other: chlorhexidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Complete denture wearer healthy ability to comply with the experimental protocol Exclusion Criteria: Candidiasis (thrush) use of antifungals, antibiotics or mouthwashes in the prior 3 months limited motor activity unhealthy

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Water<br>Patients' dentures are treated with water (placebo) once a week for 10 min. | Other: water<br> <br> * Other names: placebo;|
| Active Comparator: sodium hypochlorite<br>Patients' dentures are treated with a solution of sodium hypochlorite 0.5% once per week for 10 min | Other: sodium hypochlorite<br> <br> |
| Active Comparator: 0.5% chlorhexidine<br>Patients' dentures are treated with 0.5% chlorhexidine once a week for 10 min. | Other: chlorhexidine<br> <br> |
| Active Comparator: 0.12% sodium bicarbonate<br>Patients' dentures are treated with sodium bicarbonate 0.12% once a week for 10 min. | Other: sodium bicarbonate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of biofilm formed on the denture | Biofilm will be measured on the denture using photographs and microbial counts (baseline and after 14 days of use of one of the four hygiene protocols) after using one of the tested denture hygiene protocols. The four tested protocols (NaOCl, chlorhexidine, sodium bicarbonate, water) will be compared to see which one leads to a better hygiene of the denture. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Odor | Patients will be asked about the odor of the solution used to soak dentures through a questionnaire | 14 days |
Lidocaine-prilocaine Cream Versus Rectal Meloxicam on Relief of Post-episiotomy Pain

Study Overview
=================
Brief Summary
-----------------
Postpartum perineal pain is a very common complaint. It can have negative consequences for mother and child including disability in daily functioning for the mother; for example, it can interfere in taking care of her infant and in breastfeeding. Early pain management is thus relevant to provide relief and prevent chronicity. Perineal pain is particularly common following childbirth. Macarthur 2004, in a prospective cohort study involving 447 women in Canada, reported an incidence of perineal pain, in the first day after birth, of 75% in women with an intact perineum

Official Title
-----------------
Effect of Topical Lidocaine-prilocaine Cream Versus Rectal Meloxicam Suppository on Relief of Post-episiotomy Pain: A Randomized Clinical Trial

Conditions
-----------------
Postpartum

Intervention / Treatment
-----------------
* Drug: lidocaine-prilocaine cream
* Drug: meloxicam rectal suppository


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primiparas Normal vaginal delivery Mediolateral episiotomy Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: Patients who had postpartum hemorrhage Patients who had manual removal of the placenta Patients with contraindications to non steroidal drugs Patients with a multiple perineal lacerations
Sexes Eligible for Study
-----------------
Female

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lidocaine-prilocaine<br>women will receive 5 mg lidocaine-prilocaine cream topically on the episiotomy line | Drug: lidocaine-prilocaine cream<br>* topical cream<br>|
| Active Comparator: meloxicam<br>women will receive one 15 mg meloxicam rectal suppository | Drug: meloxicam rectal suppository<br>* suppository<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean difference of visual analog scale after delivery | the scale is graded from 0 to 10 | immediately |
Elimination of Antibiotics During Citrate-anticoagulated Continuous-veno-venous-haemodialysis

Study Overview
=================
Brief Summary
-----------------
Acute kidney injury (AKI) requiring renal replacement therapy is common in critically ill patients. The major causes of AKI are severe sepsis and septic shock requiring effective antibiotic treatment. Patients with sepsis on ICUs usually are haemodynamically instable so that renal replacement therapy is applied using continuous techniques. In recent years, the efficacy of renal replacement therapies has improved, namely by using regional citrate anticoagulation which improves filter lifetime and filter patency. At present, the extent of removal of antibiotic drugs using citrate-anticoagulated CVVHD in critically ill patients has not been investigated thoroughly. Thus, the investigators want to investigate whether and to what extent antibiotic drugs (piperacillin/tazobactam and imipenem/cilastatin) are removed during citrate-anticoagulated CVVHD per se whether filter patency during citrate-anticoagulated CVVD remains stable during a treatment period of 72 h

Official Title
-----------------
Elimination of Antibiotics During Citrate-anticoagulated Continuous-veno-venous-haemodialysis

Conditions
-----------------
Acute Kidney Injury, Bacterial Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intensive care patients with acute kidney injury requiring continous renal replacement therapy with citrate-anticoagulation Age > 18 y Exclusion Criteria: < 18 y Pregnancy Contraindications against citrate-anticoagulation or continous renal replacement therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Piperacillin/Tazobactam<br>Patients undergoing continuous veno-venous renal replacement therapy and treated with this antibiotics | |
| Imipenem/Cilastatin<br>Patients undergoing continuous veno-venous renal replacement therapy and treated with this antibiotics | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Removal of antibiotic drugs during day 1 - 2 - 3 of citrate anticoagulated CVVHD (mg/d) | Total hemofilter clearance (ml/min) of imipenem/cilastatin and piperacillin/tazobactam on each treatment day during an 8-hour dosing interval using blood sided clearance - Total amount of antibiotic drug which is eliminated via the filter during 24 h using filter clearance and delivered dialysis dose during 24 h | up to three days | 
| Filter patency during day 1 - 2 - 3 of citrate anticoagulated CVVHD | Filter patency is calculated as a function of the sieving coefficient for small solutes (i.e. creatinine and the respective antibiotic drugs) over the first 72 h, Sieving coefficient is without dimension | up to three days |
A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia

Study Overview
=================
Brief Summary
-----------------
A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia

Detailed Description
-----------------
Study will evaluate long-term safety and tolerability of a new compound in the treatment of patients with schizophrenia as assessed by adverse events (AEs), measures of extra pyramidal symptoms (EPS; Abnormal Involuntary Movement Scale [AIMS], Barnes Akathisia Scale [BAS], and Simpson-Angus Rating Scale [SAS]), vital sign measurements, electrocardiograms (ECGs), clinical laboratory evaluations.

Official Title
-----------------
An Open-Label, Multicenter, Twelve-Month Study of Safety and Tolerability in the Treatment of Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Lurasidone 80mg tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients must have participated in study D1050196 (A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia) and either: Successfully completed OR Patients must have been discontinued after a minimum of 2 weeks of treatment due to lack of efficacy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Lurasidone 80 mg tablet<br>Lurasidone 80mg oral tablet taken once a day | Drug: Lurasidone 80mg tablet<br> <br> * Other names: Lurasidone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Latuda, Schizophrenia, Lurasidone
Tumor Characteristics, Pre-transplant Treatments and Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
Recurrence after liver transplantation for hepatocellular carcinoma (HCC) represents an important cause of mortality for this surgical population. In addition to tumor characteristics, It has been suggested that pre-treatment and sirolimus-based immunosuppression may affect recurrence and survival. With data from the European Liver Transplant Registry (ELTR) database, the aim of this study is to investigate the impact of tumor characteristics, pre-transplant treatment and immunosuppression regimens on survival after liver transplantation for HCC.

Official Title
-----------------
The Effect of Tumor Characteristics, Pre-transplant Treatments and Immunosuppression on Survival After Liver Transplantation for Hepatocellular Carcinoma - a European Registry Study

Conditions
-----------------
Liver Transplantation

Intervention / Treatment
-----------------
* Procedure: Pre-treatment
* Drug: Sirolimus based immunosuppression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hepatocellular carcinoma within transplantation criteria Exclusion Criteria: Disseminated disease
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Pre-treatment|Non-transplantation pre-treatments prior to transplantation (e.g. radiofrequency ablation, transcatheter arterial chemoembolization)|
|Drug: Sirolimus based immunosuppression|Immunosuppression regimens containing Sirolimus|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | up to 10 year survival | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatocellular carcinoma specific survival |  | 5 year and 10 year survival |
Imaging Characteristics of a Follow-up 18F-AV-1451 Scan

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the imaging characteristics of flortaucipir in subjects with a previous flortaucipir scan in order to assess the rate of change of tau deposition over time.

Official Title
-----------------
An Open Label, Multicenter Study, Evaluating the Imaging Characteristics of a Follow-up 18F-AV-1451 Scan in Subjects Who Have Had a Prior 18F-AV-1451 Scan

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: Flortaucipir F18
* Drug: Florbetapir F 18
* Procedure: Brain PET Scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a previous 18F-AV-1451 brain scan Can tolerate up to two Positron Emission Tomography (PET) imaging sessions and a Magnetic Resonance Imaging (MRI) scan Ability to provide informed consent Exclusion Criteria: Current clinically significant psychiatric disease Are claustrophobic Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Follow-up Flortaucipir PET Scan<br> | Drug: Flortaucipir F18<br>* 370 megabecquerel (MBq) IV single-dose<br>* Other names: [F-18]T807;Drug: Florbetapir F 18<br>* 370 megabecquerel (MBq) IV single-dose<br>* Other names: 18F-AV-45;Procedure: Brain PET Scan<br>* positron emission tomography (PET) scan of the brain<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tau Deposition | Rate of tau deposition change as measured by flortaucipir standardized uptake value ratio (SUVr). For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. | baseline scan and at least 6 months after baseline scan |
Argatroban Monitoring in Critically Ill Patients: Evaluation of a Novel Ecarin-based Bedside Test

Study Overview
=================
Brief Summary
-----------------
Argatroban is a parenteral direct Thrombininhibitor used for anticoagulation in patients suffering from heparin induced thrombocytopenia (HIT). There is increasing evidence suggesting that the activated partial thromboplastine time (aPTT), which is recommended for dosage monitoring, correlates poorly with serum argatroban concentration in critically ill patients. Therefore it may be badly suited to determine the correct dosing. Ecarin based tests have been proven to be effective in determining effects of direct thrombin inhibitors. The investigators now plan to evaluate a novel, rotational thrombelastometric, ecarin based bedside test for its ability to measure the effect of argatroban in critically ill patients. So far an excellent correlation of a similar test could be shown in spiked plasma of healthy adults. According to the manufacturer the ECA-Test is able to detect direct thrombininhibitors. However to our knowledge neither the ECA-Test nor other ecarin-based thrombelastometric tests have been studied in critically ill patients treated with argatroban. The investigators therefore seek to investigate the correlation of the ECA-Test (ClotPro®) with the serum argatroban concentration.

Official Title
-----------------
Argatroban Monitoring in Critically Ill Patients: Evaluation of a Novel Ecarin-based Bedside Test

Conditions
-----------------
Heparin-induced Thrombocytopenia

Intervention / Treatment
-----------------
* Diagnostic Test: ECA-Test (Clot-Pro)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Continuous infusion of Argatroban in routine clinical use according to local standard of care Expected length of stay at ICU > 4 days 18 years Exclusion Criteria: Heparin infusion in the last fourhours

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: ECA-Test (Clot-Pro)|Thrombelastometric ECA-Test performed on Clot-Pro|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of ECA-Test CT with Argatroban Plasma Concentration | Correlation of ECA-Test CT with Argatroban Plasma Concentration on five consecutive days | ECA-Test CT and Argatroban Plasma Concentration will be measured on five consecutive days starting with inclusion in the study on day 0. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Argatroban, ECA-Test, Ecarin, Clot-Pro, Thrombelastometry, ROTEM