linjc16/ctgov huggingface dataset:
Relation Between Renin-Angiotensin Gene Polymorphisms, Plasma Adiponectin and Arterial Stiffness in Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Relation between Renin-Angiotensin Gene Polymorphisms, Plasma Adiponectin and Arterial Stiffness in Renal Transplant Recipients

Official Title
-----------------
Relation Between Renin-Angiotensin Gene Polymorphisms, Plasma Adiponectin and Arterial Stiffness in Renal Transplant Recipients

Conditions
-----------------
Vascular Diseases, Arterial Stiffness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 18 and 80 years, extremes included Kidney transplants with or without other transplant organs Informed consent Stable clinical condition on the basis of a pre-trial physical examination, medical history, and the results of blood biochemistry and haematology tests Exclusion Criteria: Pregnant, lactating females Recent (< 4 weeks) change in antihypertensive drug medication Current or recent (< 2 weeks) acute illness such as infection or bleeding Current treatment for malignancy

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 |
| --- | --- | --- |
Comparaison of ESP Block and TAP Block

Study Overview
=================
Brief Summary
-----------------
This study aim to compare the efficiency and the analgesic effect of Erector Spinal Plane Block versus TAP Block after laparoscopic cholecystectomy.

Detailed Description
-----------------
This study will include patients scheduled for laparoscopic cholecystectomy, ASA status 1 or 2. patients will be randomized in 2 groups to recieve post operative analgesia with -ESP block: bilateral injection of 20 ml of isobaric Bupivacain 0,375% in the paraverebral space T5. or -TAP block: bilateral injection of 15 ml of Isobaric Bupivacain 0,5%

Official Title
-----------------
ESP Versus TAP for Analgesia After Laparoscopic Cholecystectomy

Conditions
-----------------
Post Operative Pain

Intervention / Treatment
-----------------
* Procedure: ESP Block
* Procedure: TAP Block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients ASA status I or II scheduled for laparoscopic cholecystectomy Exclusion Criteria: laparotomy unplanned ICU admission

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESP group<br>ESP block: bilateral injection of 20 ml of isobaric Bupivacain 0,375% in the paraverebral space T5. | Procedure: ESP Block<br>* ESP block: bilateral injection of 20 ml of isobaric Bupivacain 0,375% in the paraverebral space T5.<br>|
| Experimental: TAP Block<br>TAP block: bilateral injection of 15 ml of Isobaric Bupivacain 0,5% | Procedure: TAP Block<br>* TAP block: bilateral injection of 15 ml of Isobaric Bupivacain 0,5%<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative analgesia | Post operative analgesia assessed with Numerical rating scale (0=minimum, 10= Maximum) | 24 hours after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative analgesic consumption | Amount of Morphin needed for analgesia | 24 hours after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic cholecystectomy, Post Operative, Analgesia
Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus

Official Title
-----------------
Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Dexcom CGM System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Confirmed pregnancy Diagnosis of Gestational Diabetes (GDM), Type 1 Diabetes Mellitus (T1DM), or Type 2 Diabetes Mellitus (T2DM) Willing to wear up to the required number of Systems for the total duration of study wear Able to follow study procedures; Able to speak, read, and write in English or Spanish. Exclusion Criteria: Extensive skin changes/diseases that preclude wearing the required number of Systems at the proposed wear sites Known allergy to medical-grade adhesives Hematocrit outside specification Prescribed drugs for treatment of pre-term labor or experiencing high-risk pregnancy complications during current pregnancy Currently receiving dialysis treatment or planning to receive dialysis during the sensor wear period Currently using Hydroxyurea for treatment Require a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the sensor wear period

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

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dexcom CGM System<br>Dexcom CGM System | Device: Dexcom CGM System<br>* Dexcom CGM System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dexcom Continuous Glucose Monitoring (CGM) System Performance | The Dexcom Continuous Glucose Monitoring (CGM) System performance will be assessed compared to Yellow Springs Instrument (YSI) comparator venous plasma measurements | 10 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Related Adverse Device Effects | The Dexcom Continuous Glucose Monitoring (CGM) System will be characterized by Adverse Device Effects experienced by study participants | 10 Days |
TBTC Study 23B:Intensive PK of the Nelfinavir Rifabutin Interaction in Patients With HIV-TB

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To define the impact of nelfinavir (given at 1250mg bid as part of a combination antiretroviral regimen) on peak levels and area under the curve for rifabutin and the rifabutin metabolite, 25-O-desacetyl rifabutin when rifabutin is given at 300 mg bi-weekly as part of tuberculosis chemotherapy. Secondary Objectives: To compare the pharmacokinetics of nelfinavir given twice daily at 1250 mg bid with twice-weekly isoniazid and rifabutin to the pharmacokinetics of nelfinavir 1250 mg twice-daily in historical HIV-infected patients not receiving isoniazid and rifabutin. To evaluate the correlation between pharmacokinetic parameters of rifabutin and 25-O-desacetyl rifabutin and the occurrence of toxicity attributed to rifabutin in patients with HIV-related tuberculosis. To define detailed pharmacokinetics of isoniazid given at 15mg/kg or 900 mg in patients with HIV-related tuberculosis. To attempt to derive optimal sampling times for nelfinavir and rifabutin pharmacokinetic studies.

Official Title
-----------------
TBTC Study 23B:Intensive Pharmacokinetics of the Nelfinavir Rifabutin Interaction in Patients With HIV-Related Tuberculosis Treated With a Rifabutin-Based Regimen

Conditions
-----------------
HIV Infections, Tuberculosis

Intervention / Treatment
-----------------
* Drug: Nelfinavir
* Drug: Rifabutin


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with HIV-related tuberculosis

Ages Eligible for Study
-----------------
Minimum Age: 0 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

| Intervention/Treatment |
| --- |
|Drug: Nelfinavir|nan|
|Drug: Rifabutin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of nelfinavir (given at 1250mg bid as part of a combination antiretroviral regimen) on area under the curve for rifabutin and 25-O-desacetyl rifabutin when rifabutin is given 300 mg bi-weekly as part of tuberculosis chemotherapy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the pharmacokinetics of nelfinavir given twice daily at 1250 mg bid with twice-weekly isoniazid and rifabutin to the pharmacokinetics of nelfinavir 1250 mg twice-daily in historical HIV-infected patients not receiving isoniazid and rifabutin. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tuberculosis, TB
International Melanoma Algorithm Training Study - IMATS

Study Overview
=================
Brief Summary
-----------------
This is an international, multicenter, prospective, non controlled, non randomized, clinical study to collect electrical impedance data of potentially malignant pigmented nevi and histological diagnoses (International Melanoma Algorithm Training Study [IMATS]). The study objective is to collect data for training and optimization of an algorithm that can classify skin lesions using electrical impedance, i.e., to identify malignant melanomas.

Official Title
-----------------
An International, Multicenter, Prospective, Non-controlled, Non-randomised, Clinical Study to Collect Impedance Data of Potentially Malignant Pigmented Nevi and Histological Diagnoses

Conditions
-----------------
Malignant Melanoma

Intervention / Treatment
-----------------
* Device: SciBase III Electrical Impedance Spectrometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women of any ethnic group Lesion located on normal healthy skin Maximum number of eight lesions per patient etc. Exclusion Criteria: Lesion under finger and toe nails Lesion located on eczema, psoriasis areas or similar Lesion located on scars etc.

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: SciBase III Electrical Impedance Spectrometer|Following enrollment, patients will undergo measurements with SciBase III Electrical Impedance Spectrometer. Electrical impedance of the skin will be measured with a microinvasive spiked probe.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome measure not applicable. This is an algorithm training study. |  | Q1 2010 |
Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Osteoarthritic Pain

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the efficacy and safety of BTDS compared to placebo in subjects with moderate to severe osteoarthritic pain of the hip or knee.

Detailed Description
-----------------
The primary objective of this study is to evaluate the efficacy and safety of buprenorphine transdermal system (BTDS) compared to placebo in subjects with moderate to severe osteoarthritic pain of the hip or knee who have a sub-optimal response to their non-opioid analgesic treatment and require opioid analgesics for pain control.

Official Title
-----------------
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Determine the Efficacy and Safety of BTDS Compared to Placebo in Subjects With Moderate to Severe Osteoarthritic Pain of the Hip or Knee

Conditions
-----------------
Pain, Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Buprenorphine Transdermal System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females ages 40 years or older. Clinical diagnosis of osteoarthritis (OA) of the hip or knee. Exclusion Criteria: Subjects who have a current or past history of chronic disease(s), in addition to OA, requiring frequent analgesic therapy (e.g. headache, fibromyalgia, gout, rheumatoid arthritis, low back pain, and diabetic neuropathy).

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Placebo Comparator: 0<br> | Drug: Placebo<br>* Corresponding placebo is applied for 12weeks<br>|
| Experimental: 1<br> | Drug: Buprenorphine Transdermal System<br>* Buprenorphine Transdermal System 5, 10 or 20mg/patch is applied for 12weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to the development of inadequate analgesia |  | Up to 12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects who developed inadequate analgesia, 'Average pain over the last 24 hours' scores |  | 12weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritic Pain
A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease.

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of R1450 in patients with mild to moderate Alzheimer Disease. Patients will be randomized to receive either R1450 or placebo by intravenous infusion for a total of 7 doses. The starting dose will be escalated in subsequent cohorts of patients in an adaptive manner, after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Official Title
-----------------
A Multi-center, Multiple-ascending Dose, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO4909832 Following Intravenous Infusion in AD Patients

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

Intervention / Treatment
-----------------
* Drug: gantenerumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, 50-90 years of age; diagnosis of probable Alzheimer Disease, with symptoms >=1 year prior to screening; meets DSM-IV criteria for Alzheimer-type dementia; stabilised on approved medications for treatment of Alzheimer Disease for >=4 months prior to baseline. Exclusion Criteria: active major depressive disorder, or a history of bipolar disorder; history of schizophrenia; concurrent participation in a non-pharmacological trial with a key objective of improving cognition; prior randomisation in any R1450 trial.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 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 |
| --- | --- |
| Experimental: 1<br> | Drug: gantenerumab<br>* Administered iv at escalating doses (7 cohorts)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs, laboratory parameters, vital signs. |  | Throughout study | 
| Pharmacokinetic parameters of R1450 in plasma |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSF biomarkers, clinical efficacy parameters. |  | Throughout study |
Efficacy of Functional Magnetic Stimulation in Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
Functional Magnetic Stimulation (FMS) appears to modulate autonomic and somatic nervous systems that innervate the lower urinary tract. Stimulation of the pudendal afferent nerve near the third sacral root induces relaxation of the detrusor muscles and reinforcement of urethral sphincter. Some preliminary studies had indicated the positive effect of FMS on stress urinary incontinence. Investigators aimed to evaluate the immediate and long-term effect of this method on stress urinary incontinent patients.

Detailed Description
-----------------
5 Hz repetitive magnetic stimulation was applied over bilateral sacral roots for 20 minutes.

Official Title
-----------------
Efficacy of Functional Magnetic Stimulation in Urinary Incontinence

Conditions
-----------------
Incontinence

Intervention / Treatment
-----------------
* Device: FMS (Magstim rapid2)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Urine incontinence refractory to traditional treatment Exclusion Criteria: Arrhythmia, pacemaker implantation

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Real FMS, 5 Hz, 20 minutes per day, for 10 weekdays. | Device: FMS (Magstim rapid2)<br>* 5 Hz FMS, over bilateral sacral roots.<br>|
| Sham Comparator: sham group<br>sham FMS, 5 Hz, 20 min per day, for 10 weekdays. | Device: FMS (Magstim rapid2)<br>* 5 Hz FMS, over bilateral sacral roots.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom scoring on Urge-Urinary Distress Inventory questionnaire |  | up to 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cystometry and stress urethral pressure profile as measures of objective incontinence improvement |  | up to 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FMS, Urine incontinence
Effectiveness of Artemether-Lumefantrine for Malaria Treatment of Children at Community Level in Tanzania

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to assess the effectiveness of artemether-lumefantrine (Coartem®) treatment provided by community health workers against uncomplicated malaria in children under 5 years of age in Kibaha District, Tanzania, during an extended follow-up of 42 days. The hypothesis is that artemether-lumefantrine treatment provided by community health workers will result in less than 85% PCR-corrected parasitological effectiveness by day 42, mainly due to partial non-compliance to full standard 6-dose regimen of the drug.

Official Title
-----------------
Effectiveness of Artemether-Lumefantrine Treatment Provided by Community Health Worker Against Uncomplicated Malaria in Children Under 5 Years of Age in Tanzania

Conditions
-----------------
Malaria

Intervention / Treatment
-----------------
* Drug: artemether-lumefantrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged <5 years Weight >5 kg Suffering from acute uncomplicated P. falciparum malaria confirmed by RDT. Later microscopy using Giemsa-stained thick film will be made to ensure asexual parasite density of 2000 to 200 000 parasites/µL Having a history of fever in the preceding 24 h Able to ingest tablets orally Willing and able to attend stipulated follow-up visits With written informed consent from parent/guardian for children to participate in the trial. Exclusion Criteria: Presenting with any of the following danger signs of severe malaria: Convulsions (>1 episode within previous 24 hours) Lethargic/unconscious

Ages Eligible for Study
-----------------
Maximum Age: 5 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

| Intervention/Treatment |
| --- |
|Drug: artemether-lumefantrine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness (PCR adjusted parasitological cure rate) of artemether-lumefantrine |  |  | 
| during 42 days follow-up. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malaria, Plasmodium falciparum, artemether-lumefantrine, effectiveness