louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00512330: Lipoarabinomannan (LAM) Enzyme-Linked Immunosorbent Assay (ELISA) in Diagnostics of Childhood Tuberculosis (TB)
Official title: Evaluation of Urine Lipoarabinomannan ELISA In Diagnostics of Childhood Tuberculosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tuberculosis
Keywords: childhood
tuberculosis
diagnostic
lipoarabinomannan
ELISA
Tuberculosis in Childhood
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
Collaborators: name: Our Lady of Mount Carmel Community Hospital, Kapiri, Malawi
name: Ministry of Health and Population, Malawi
name: Mbeya Medical Research Programme, Mbeya, Tanzania
name: Unterstützerkreis Missionskrankenhaus Kapiri e.V., Munich, Germany
name: Foerderverein AIDS im Kindesalter in Bonn e.V., Bonn, Germany
name: Children's Medical Hospital, University of Bonn, Germany
First posted: 2007-08-07
Enrollment: 250
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Study population: Children up to 14 years of age with suspicion of TB

Brief summary: In children, it remains quite difficult even in developed countries, to prove a diagnosis of Tuberculosis (TB). New means for diagnosis of this disease are currently being researched. One candidate test is Lipoarabinomannan ELISA from Urine, which has shown good sensitivity of up to 80% in adults.

Our study aims to evaluate this test in the diagnosis of children with TB.

Detailed description: Among candidate new diagnostics for TB, a test for mycobacterial Lipoarabinomannan (LAM) excretion in urine has shown promising results in one Tanzanian study: The sensitivity for detecting TB culture-positive patients was 80.3%. Of 103 healthy volunteers, only one gave a false positive result (Boehme, 2005).

Until now, there are only data concerning this test for diagnosis of adult disease. For evaluation of routine use in children in countries like Malawi, we are starting a prospective study. Children 0-14 years of age with suspected TB will be investigated using TB culture as the gold standard. In sputum samples, microscopy will be done. Simultaneously, LAM Elisa from the patient´s urine will be done.

Eligibility criteria: Inclusion Criteria:

* age 0-14 years
* suspicion of active TB or TB contact

Exclusion Criteria:

* no informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kapiri/Mchinji
country: Malawi
facility: Our Lady of Mount Carmel Hospital
state: Mchinji
Study officials:
affiliation: University of Bonn
name: Norbert Heinrich, MD
role: STUDY_CHAIR
affiliation: Our Lady of Mount Carmel Hospital, Kapiri
name: John Chimphamba, Clinical Officer
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bonn
name: Andreas Mueller, PD Dr med.
role: STUDY_CHAIR
References:
Clinical trial NCT01709630: PK/PD Modeling of Magnesium in the Mother and Neonate
Official title: Pharmacokinetics (PK)/Pharmacodynamics (PD) Modeling of Magnesium Sulfate In the Mother and Exposed Neonate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Magnesium Sulfate Pharmacokinetics and Pharmacodynamics
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-10-18
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women and neonates exposed to magnesium sulfate infusion around the time of delivery for one of three reasons: 1.) preeclampsia 2.) tocolysis 3.) neuroprotection.

Brief summary: Determine significant correlations between maternal serum magnesium levels, and maternal and neonatal outcomes.

Detailed description: We will construct a pharmacokinetic and pharmacodynamic model of intravenous magnesium sulfate administered antenatally to expectant mothers and exposed fetuses with the aim of optimizing maternal and fetal outcomes while preventing maternal and neonatal overdosing and morbidity associated with current magnesium treatment protocols. Once we have developed a PK/PD model in our own hospital cohort, we will apply this model to a large existing NICHD database to mathematically calculate optimal dosing protocols.

Eligibility criteria: Inclusion Criteria:

* Pregnant women ages 18-45 years
* Magnesium sulfate exposure for preeclampsia, tocolysis, or neuroprotection
* Neonates (male or female) born at 24-42 weeks gestation

Primary outcomes:
measure: Maternal and neonatal blood magnesium levels
timeFrame: 24 months
Secondary outcomes:
measure: Maternal and neonatal side effects
timeFrame: 24 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Lucille Packard Children's Hospital at Stanford University Medical Center
state: California
Study officials:
References:
citation: Rouse DJ, Hirtz DG, Thom E, Varner MW, Spong CY, Mercer BM, Iams JD, Wapner RJ, Sorokin Y, Alexander JM, Harper M, Thorp JM Jr, Ramin SM, Malone FD, Carpenter M, Miodovnik M, Moawad A, O'Sullivan MJ, Peaceman AM, Hankins GD, Langer O, Caritis SN, Roberts JM; Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units Network. A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy. N Engl J Med. 2008 Aug 28;359(9):895-905. doi: 10.1056/NEJMoa0801187.
citation: Pryde PG, Mittendorf R. Contemporary usage of obstetric magnesium sulfate: indication, contraindication, and relevance of dose. Obstet Gynecol. 2009 Sep;114(3):669-673. doi: 10.1097/AOG.0b013e3181b43b0e.
citation: Greenberg MB, Penn AA, Whitaker KR, Kogut EA, El-Sayed YY, Caughey AB, Lyell DJ. Effect of magnesium sulfate exposure on term neonates. J Perinatol. 2013 Mar;33(3):188-93. doi: 10.1038/jp.2012.95. Epub 2012 Jul 26.
Clinical trial NCT01541930: An Open, Uncontrolled Study of GK567 in the Deodorization of Malodorous Fungating Neoplastic Tumours
Official title: An Open, Uncontrolled Study Investigating the Safety and Efficacy of GK567 in the Deodorization of Malodorous Infected Cutaneous Fungating Neoplastic Tumours, Over 14 Days of Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malodorous Infected Cutaneous Ulcer
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2012-03-01
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial objective is to investigate the safety and efficacy of GK567 to alleviate malodour of foul smelling, anaerobically infected fungating neoplastic tumours, over 14 days of treatment.

The clinical hypothesis is that the success rate is no worse than 70% in the population of interest, where success for a patient is defined as a smell score of 0 or 1 at Day 14/end of treatment, as assessed by the Study Investigator.


Eligibility criteria: Inclusion Criteria:

* The subject is a male or female aged between 20 years or older.
* The subject has a cutaneous fungating neoplastic tumour with a smell that suggests established or early infection, with a minimum score of 2 (i.e. mildly offensive smell) on a 0-4 smell scale, (based on the Study investigator's assessment)

Exclusion Criteria:

* The subject is currently receiving systemic antibiotics or received in the last 2 weeks,
* The subject is currently receiving systemic or topical Metronidazole or received in the last week,
* The subject is currently receiving topical antibiotics or received such treatment applied on cutaneous fungating neoplastic tumour in the last 1 week,
* The subject already receives any topical treatment on the cutaneous fungating neoplastic tumour

Primary outcomes:
measure: The Success Rate
timeFrame: at Day 14 (end of treatment)
Secondary outcomes:
measure: Smell Score by Investigator
timeFrame: on Days 0 (baseline), 7, and 14
measure: Smell Score by Nurse
timeFrame: on Days 0 (baseline), 7, and 14
measure: Smell Score by Patient
timeFrame: on Days 0 (baseline), 7, and 14
measure: Appearance (Volume and Nature of Discharge at Cutaneous Ulcer)
timeFrame: on Days 0 (baseline), 7, and 14
measure: Pain (Visual Analogue Scale)
timeFrame: on Days 0 (baseline), 7, and 14
Other outcomes:
Locations:
city: Kanagawa
country: Japan
facility: Galderma investigational site
city: Tokyo
country: Japan
facility: Galderma investigational site
Study officials:
References:
Clinical trial NCT02013830: A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) in Patients With Advanced or Metastatic Liver Cancer
Official title: A Single-arm, Open-label Study of Avastin Plus Xeloda on Objective Treatment Response in Patients With Advanced or Metastatic Liver Cancer Who Have Had no Previous Cytotoxic Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-12-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of oral Xeloda (capecitabine) plus intravenous Avastin (bevacizumab) in patients with advanced or metastatic liver cancer. The anticipated time on study treatment is 3-12 months.


Eligibility criteria: Inclusion Criteria:

* adult patients \>=18 years of age;
* advanced or metastatic liver cancer;
* \>=1 measurable lesion.

Exclusion Criteria:

* current radiotherapy, chemotherapy, or other experimental therapies;
* prior cytotoxic chemotherapy;
* major surgery, open biopsy, or traumatic injury within 28 days of study entry;
* history of a malignancy during the last 5 years, other than cutaneous basal cell cancer or in situ cervical cancer.

Primary outcomes:
measure: Percentage of Participants With Objective Response (OR)
timeFrame: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Secondary outcomes:
measure: Percentage of Participants With Disease Control
timeFrame: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
measure: Time to Disease Progression - Percentage of Participants With an Event
timeFrame: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
measure: Time to Disease Progression
timeFrame: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
measure: Time to Disease Progression - Percentage of Participants Progression-free at 12 Months
timeFrame: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
measure: Overall Survival - Percentage of Participants With an Event
timeFrame: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
measure: Overall Survival
timeFrame: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
measure: Overall Survival - Percentage of Participants Event Free at 12 Months
timeFrame: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Other outcomes:
Locations:
city: Melbourne
country: Australia
city: Hong Kong
country: Hong Kong
city: Singapore
country: Singapore
city: Kueishan
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00600730: The Effects of Antecedent Hypoglycemia or Exercise on the Response of the Brain to Subsequent Hypoglycemia
Official title: The Effects of Antecedent Hypoglycemia or Exercise on the Response of the Brain to Subsequent Hypoglycemia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 1 Diabetes
Keywords: fMRi
hypoglycemia
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-01-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The studies proposed in this application seek to use non-invasive techniques to examine the impact of repeated hypoglycemia on the brain.

Detailed description: The studies proposed in this application seek to use non-invasive techniques to examine the impact of repeated hypoglycemia on the brain.

During the past decade many studies have shown that appropriate magnetic resonance imaging (MRI) methods may be used to assess alterations in brain regional activation in response to external stimuli or tasks. Thus, this non-invasive technique will enhance our ability to learn more about brain function, during hypoglycemia and may delineate information about the role of the brain in hypoglycemia associated autonomic dysfunction.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects aged 18-45
* Type 1 diabetes mellitus patients aged 18-45
* Body Mass Index 21-38 kg/m2
* Normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities and an EKG stress test.
* Female volunteers of childbearing potential will undergo HCG pregnancy test. Only women who are not pregnant will participate in the study.

Diabetic Subjects:

* HBA1C= 5.5-11.0%
* Duration of Type 1 Diabetes \> 3 yr
* Normal bedside autonomic function

Exclusion Criteria:

All Subjects

* Prior or current history of poor health
* Abnormal results following screening tests
* Pregnancy
* Subjects unable to give voluntary informed consent
* Subjects with a recent medical illness
* Subjects with a history of hypertension, heart disease or cerebrovascular disease
* Subjects with known liver or kidney disease
* Subjects with recent weight loss or consuming a low carbohydrate diet
* Subjects taking steroids
* Subjects taking beta-blockers
* Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
* Evidence of diabetic neuropathy, autonomic neuropathy, proteinuria, extensive background or proliferative retinopathy, hypertension, or cardiovascular disease

Primary outcomes:
measure: fMRi scans
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University
name: Stephen N Davis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06527430: Different Local Anesthetic Volumes for Unilateral Spinal Anesthesia
Official title: Different Local Anesthetic Volumes for Unilateral Spinal Anesthesia in Varicose Vein Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Discharge Time
Ambulatory Surgery
Spinal Anesthesia
Keywords: local anesthetic volume
varicose vein surgery
ambulatory surgery
spinal anesthesia
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-07-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Varicose veins are irreversible and abnormal enlargement of the veins. These veins appear and there are curled swellings under the skin in the feet and legs. Complaints increase when standing and sitting for long periods. For varicose veins in the initial stages, medical treatment methods such as compression socks (elastic socks) and elevating the feet as much as possible can be tried. For widespread varicose veins in more advanced stages, invasive procedures such as sclerotherapy and endovascular ablation are performed. These procedures can be performed under local, spinal or general anesthesia.

Spinal anesthesia; It is a type of neuraxial type of regional anesthesia characterized by injecting local anesthetic drugs into the subarachnoid space alone or together with other drugs, resulting in temporary sensory block, motor block, and sympathetic block. The local anesthetic volume administered during spinal anesthesia may affect the anesthesia levels and discharge times of the patients. For varicose vein surgeries, low-dose local anesthetic is sufficient for spinal anesthesia and can also provide early discharge.

This study will compare the peri-operative effects of different doses of spinal anesthesia in patients undergoing varicose vein surgery.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-80 years
* American Society of Anesthesiologists (ASA) score I-II
* Body Mass Index (BMI) between 18-30 kg/m2
* Patients who underwent spinal anesthesia (bupivacaine 4 mg or 6 mg) for varicose vein surgery in the operating theatre

Exclusion Criteria:

* Patients under 18 and over 80 years of age
* ASA score III and above
* Patients with a history of bleeding diathesis
* Patients with infection in the area to be treated
* BMI below 18 or above 30 kg/m2

Primary outcomes:
measure: Discharge time
timeFrame: On the operation day
Secondary outcomes:
measure: Motor block appearing time
timeFrame: On the operation day
measure: Sensorial block appearing time
timeFrame: On the operation day
measure: Motor block disappearing time
timeFrame: On the operation day
measure: Sensorial block disappearing time
timeFrame: On the operation day
Other outcomes:
Locations:
city: Yenimahalle
country: Turkey
facility: Ankara Etlik City Hospital
state: Ankara
Study officials:
References:
Clinical trial NCT01144130: Postoperative Sleep Disturbances After Fast Track Hip and Knee Replacement
Official title: Postoperative Sleep Disturbances After Fast Track Hip and Knee Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: REM Sleep Measurement
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Lundbeck Center for Fast-Track Hip and Knee Replacement
First posted: 2010-06-15
Enrollment: 10
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients above 60 years undergoing hip/knee replacement surgery in a fest track set-up.

Brief summary: The purpose of this study is to quantify the degree of sleep disturbances after hip or knee replacement surgery.

Through polysomnographic monitoring the disturbances in sleep stages will be clarified.


Eligibility criteria: Inclusion Criteria:

* above 60
* ASA classification I-IV

Exclusion Criteria:

* general anaesthesia within 90 days
* daily use of sedatives
* alcohol abuse
* insufficient written and verbal Danish
* severe hearing loss and poor sight
* Parkinsons Disease or other functional neurological deficits
* Mini mental status \< 24

Primary outcomes:
measure: Duration of REM sleep before and first postoperative night
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Lene Krenk, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02272530: Analysis of Proteome and Pathophysiological Characteristics of Human Blood Cells
Official title: Analysis of Proteome and Pathophysiological Characteristics of Human Blood Cells
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Red Blood Cell
Peripheral Blood Mononuclear Cell
Endothelial NO-synthase
Keywords: Endothelial NO-synthase
red blood cell
erythrocytes
Peripheral Blood Mononuclear Cell
cardiovascular disease
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2014-10-23
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 healthy volunteers and 100 patient with stable coronary artery disease

Brief summary: The aim of this study is to investigate wether change in endothelial nitric oxid synthase of blood cells (erythrocytes and peripheral blood mononuclear cells (PBMC)) has an influence on development and progression of cardiovascular diseases.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* Patients: stable coronary artery disease with accordingly endothelial dysfunction

Exclusion Criteria:

* acute inflammation (CRP\>0,5 mg/dl, leucocyte \>11000/dl)
* malignant diseases
* acute or terminated kidney disease
* relevant heart failure (NYHA III-IV)

Primary outcomes:
measure: Blood examination
timeFrame: baseline
Secondary outcomes:
measure: Protein expression
timeFrame: baseline
measure: Asymmetric dimethylarginine (ADMA) and Cytokine
timeFrame: baseline
measure: Microparticles
timeFrame: baseline
measure: Immunocytochemistry
timeFrame: baseline
measure: Nitric oxid metabolite and proteins in blood plasma, red blood cells and peripheral blood mononuclear cells (PBMN)
timeFrame: baseline
measure: Nitric oxid and reactive oxygen species
timeFrame: baseline
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: University Hospital Duesseldorf
Study officials:
affiliation: Department of Cardiology, Pneumology and Angiology, University Hospital Duesseldorf
name: Malte Kelm, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00518830: Treatment of Postnatal Depression for Low-Income Mothers in Primary Care in Santiago, Chile
Official title: Randomized Clinical Trial for the Treatment of Postnatal Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postnatal Depression
Keywords: postnatal depression
primary care
depressed women
Lead sponsor: Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Sponsor class: OTHER_GOV
First posted: 2007-08-21
Enrollment: 230
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized clinical trial was carried out at primary care level in Santiago, Chile to investigate a combined treatment for women suffering post-natal depression and preventing the adverse consequences of this illness on infant's growth and development.

Detailed description: Background: We compared the effectiveness of a multi-component intervention with usual care to treat postnatal depression among low-income mothers in primary care clinics in Santiago, Chile.

Methods: Randomised controlled trial. Two hundred and thirty mothers with major depression attending postnatal clinics were randomly allocated to either a multi-component intervention or usual care. The multi-component intervention involved a psychoeducational group, treatment adherence support, and pharmacotherapy if needed. Data were analysed on an intention-to-treat basis. The main outcome measure was the Edinburgh Postnatal Depression Scale (EPDS) at 3 and 6 months after randomisation.

Eligibility criteria: Inclusion Criteria:

* Mothers meeting criteria for current DSM-IV major depression were eligible.

Exclusion Criteria:

* who had received any form of treatment for their depression during their current postnatal period,
* those who were pregnant,
* with psychotic symptoms,
* serious suicidal risk,
* history of mania,
* alcohol or drug abuse

Primary outcomes:
measure: EPDS
timeFrame: 3 and 6 months
Secondary outcomes:
measure: four dimensions of the Short Form-36 (SF-36) Questionnaire: mental health; emotional role; social functioning; and vitality(34) and significant clinical improvement.
timeFrame: 3 and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Chile
name: Graciela Rojas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rojas G, Fritsch R, Solis J, Jadresic E, Castillo C, Gonzalez M, Guajardo V, Lewis G, Peters TJ, Araya R. Treatment of postnatal depression in low-income mothers in primary-care clinics in Santiago, Chile: a randomised controlled trial. Lancet. 2007 Nov 10;370(9599):1629-37. doi: 10.1016/S0140-6736(07)61685-7.