louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01318512: An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Chronic Kidney Disease Not On Dialysis
Official title: The Dosage of MIRCERA in the Treatment of Renal Anaemia in Patients With Chronic Renal Disease Who do Not Undergo Haemodialysis in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Disease, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-03-18
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic kidney disease receiving Mircera treatment

Brief summary: This observational, prospective, multicenter study will describe the mean dose of Mircera (methoxy polyethylene glycol-epoetin beta) and the hemoglobin levels in patients with chronic kidney disease. Patients are not on dialysis and are naive to, or have received erythropoiesis stimulating agent treatment. Data will be collected for 10 months.


Eligibility criteria: Inclusion Criteria:

* Adults patients, \>/=18 years of age
* Presence of chronic kidney disease (Stage 3-4)

Exclusion Criteria:

* Participation in another clinical study

Primary outcomes:
measure: Average Dose of MIRCERA at Entry Level
timeFrame: Baseline
measure: Average Dose of MIRCERA During Titration Period Month 1
timeFrame: Month 1
measure: Average Dose of MIRCERA During Titration Period Month 2
timeFrame: Month 2
measure: Average Dose of MIRCERA During Titration Period Month 3
timeFrame: Month 3
measure: Average Dose of MIRCERA During Titration Period Month 4
timeFrame: Month 4
measure: Average Dose of MIRCERA During Maintenance Period Month 1
timeFrame: Month 5 (Maintenance Period Month 1)
measure: Average Dose of MIRCERA During Maintenance Period Month 2
timeFrame: Month 6 (Maintenance Period Month 2)
measure: Average Dose of MIRCERA During Maintenance Period Month 3
timeFrame: Month 7 (Maintenance Period Month 3)
measure: Average Dose of MIRCERA During Maintenance Period Month 4
timeFrame: Month 8 (Maintenance Period Month 4)
measure: Average Dose of MIRCERA During Maintenance Period Month 5
timeFrame: Month 9 (Maintenance Period Month 5)
measure: Average Dose of MIRCERA During Maintenance Period Month 6
timeFrame: Month 10 (Maintenance Period Month 6)
Secondary outcomes:
measure: The Mean Hemoglobin (Hb) Level During Titration Period
timeFrame: Baseline, Month 1, 2, 3, 4
measure: The Mean Hemoglobin (Hb) Level During Maintenance Period
timeFrame: Month 5, 6, 7, 8, 9, 10
Other outcomes:
Locations:
city: Novy Jicin
country: Czechia
facility: Nemocnice Novy Jicin; Dialyzacni Stredisko
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04406012: Analgesic Efficacy of Ultrasound Guided Paravertebral Block in Percutaneous Nephrolithotomy Patients
Official title: Analgesic Efficacy of Ultrasound Guided Paravertebral Block in Percutaneous Nephrolithotomy Patients: A Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative; Anesthesia, Regional
Keywords: Pain management
Analgesia
paravertebral block
nephrolithotomy
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
Collaborators: name: Kırıkkale University
First posted: 2020-05-28
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Paravertebral block group and Control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to investigate the analgesic effects of thoracal paravertebral block in the patients undergoing percutaneous nephrolitotomy. Paravertebral block was applied to the study group. Conventional analgesia methods were applied to the control group.

Detailed description: Randomization was divided into two groups by using closed envelope method. Postoperative pain scores at rest at 1, 2, 4, 6, 8, 10, 12, and 24 hours with VAS (0 = no pain, very severe pain = 10) using Visual Analogue Scale was made. VAS at rest and movement (coughing and taking a deep Breath) were evaluated. Patients with VAS\> 4 received additional analgesics.

Eligibility criteria: ASA I, II, III patients aged 18-65 who consented to undergo unilateral percutaneous nephrolithotomy were eligible for the study. 53 patients were eligible and assesed.Informed consent was signed by all patients. Patients under 18 years of age, pregnant, with known hypersensitivity to local anesthetics, bleeding diathesis, depression and / or anxiety disorder, obesity (BMI\> 35kg / m2), history of pneumothorax, phrenic nerve paralysis, severe aortic stenosis were excluded. Also who did not want to participate the study.

Primary outcomes:
measure: Patient VAS scores
timeFrame: 24 hours
Secondary outcomes:
measure: Patient Satisfaction scores
timeFrame: at the end of the 24 hours
Other outcomes:
Locations:
Study officials:
References:
citation: Yaman F, Tuglu D. Analgesic efficacy of ultrasound guided paravertebral block in percutaneous nephrolithotomy patients: a randomized controlled clinical study. BMC Anesthesiol. 2020 Sep 29;20(1):250. doi: 10.1186/s12871-020-01169-6.
Clinical trial NCT02885012: Crossover Study From Macitentan or Bosentan Over to Ambrisentan
Official title: A Safety and Clinical Efficacy Study Measuring Echocardiographic Composite Comparing Ambrisentan (Letairis®) After a Switch From Bosentan (Tracleer®) or Macintentan (Opsumit®) in Treatment of Pulmonary Arterial Hypertension (PAH)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Ochsner Health System
First posted: 2016-08-31
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn more about the safety and effects of switching treatments from bosentan (Tracleer) or macientan (Opsumit) to ambrisentan (Letairis) over 24 weeks in subjects with Connective Tissue Disease associated Pulmonary Arterial Hypertension (CTD-PAH).

Detailed description: The study will consist of a group of subjects who have been on bosentan for at least three months and a group that has been on macitentan for at least three months. Both groups will be switched to Letairis 5mg daily after the bosentan or macitentan therapy for three months and then increased to a dose of Letairis 10mg daily at week 4 if well tolerated.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of a Connective Tissue Disease (CTD)
* Age range: 18-80 years old
* Previous Right Heart Catheterization (RHC) demonstrating PAH
* Forced vital capacity (FVC) greater than 50%
* Carbon Monoxide Diffusing Capacity (DLCO) greater than 50%
* World Health Organization (WHO) functional class II or III
* Able to perform a 6 minute walk test (6MWT)
* Stable dose of antihypertensive medications
* Non-pregnant females
* Have to be currently on stable dose of bosentan for at least 3 months
* Adequate acoustic images to allow for transthoracic echocardiography to be performed

Exclusion Criteria:

* Exercise limitation related to a non-cardiopulmonary reason (e.g. arthritis)
* Severe systemic hypertension greater than 170/95
* Patients with a prior history of cardiovascular disease
* WHO functional class IV status
* Patients with severe other organ disease felt by investigators to impact on survival during the course of the study.
* FVC less than 50% of predicted
* DLCO less than 50% of predicted

Primary outcomes:
measure: Change in Stroke Volume
timeFrame: Baseline and 24 Weeks
Secondary outcomes:
measure: Change in EmPHasis-10 Score
timeFrame: Baseline and 24 Weeks
measure: Disease Status as Measured by Change in Biomarker
timeFrame: Baseline and 12 Weeks
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Terrill Huggins, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02675712: Effect of African Drumming in Mood Disorders
Official title: The Effect of African Drumming on on Mental Well-being Among Adults With Acute Mood Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Disorder
Bipolar Disorder
Lead sponsor: University of Stellenbosch
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 13 adults diagnosed with a mood disorder (by their own physician), aged 33 to 69 years (M = 45.38, SD = 11.48). The population included both women (n = 10) and men (n = 3). Almost half the participants were of Mixed Ethnicity (n = 6), while the remaining participants were White (n = 7).

Brief summary: This pilot study evaluated whether participating in an African drumming activity for 45 minutes immediately improved mental well-being among 13 adults diagnosed with acute mood disorders who were attending a private mental health clinic. The drumming intervention was completed by occupational therapists.

Detailed description: This pilot study evaluated the effectiveness of an occupational therapy-led African drumming group on mental well-being among adult psychiatric inpatients with mood disorders. A secondary purpose was to test a protocol for the delivery of African drumming interventions to adults with acute mood disorders.

A quasi-experimental uncontrolled one-group pre-test-post-test design was used to collect data during six drumming groups at an acute mental health clinic. Thirteen adults completed assessments of different aspects of mental well-being, including mood and enjoyment, before and after the intervention. Because this was a pilot study, participants were not assigned to any comparison groups. In addition, in-patients at the clinic received the intervention whether they participated in the study or not.

Improvement in mental well-being across different domains of mental well-being was expected, including feelings of anger, tension, confusion, depression, fatigue and vigour. The researchers also expected the intervention to be more effective in participants with previous drumming experience, and in those with lower levels of anxiety and depression.

Eligibility criteria: Inclusion Criteria:

* Attending mental health clinic
* Diagnosed mood disorder
* Voluntarily attending drumming group

Exclusion Criteria:

* Psychosis

Primary outcomes:
measure: Stellenbosch Mood Scale (STEMS)
timeFrame: Baseline and 45 minutes
Secondary outcomes:
measure: Generalised Anxiety Disorder - 7 scale (GAD-7)
timeFrame: Baseline
measure: Primary Health Questionnaire - 9 (PHQ-9)
timeFrame: Baseline
measure: Enjoyment of Interaction Scale
timeFrame: 45 minutes
Other outcomes:
Locations:
Study officials:
affiliation: University of Stellenbosch
name: Nicola A Plastow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00916812: Sensitivity of Hyomental Distance Ratio as a Single Predictor of Difficult Intubation in Obstetrics
Official title: Hyomental Distance Ratio as a Predictor for Difficult Intubation in Elective and Emergency Cesarean Section.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Caesarean Section
Keywords: Difficult intubation
Hyomental distance
Obstetric
Mallampati classification
Thyromental distance
Sternomental distance
Lead sponsor: King Khaled Eye Specialist Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Corniche Hospital
First posted: 2009-06-10
Enrollment: 188
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting for cesarean section under general anesthesia.

Brief summary: This is a study to detect the sensitivity of thyromental distance ratio as a single predictor for difficult intubation in patients undergoing cesarean section under general anesthesia.

Detailed description: The authors intend to use the HMDR for detection of difficult intubation in parturient undergoing cesarean section that is either elective or emergency.

Eligibility criteria: Inclusion Criteria:

* All patients presenting for cesarean section under general anesthesia

Exclusion Criteria:

* None

Primary outcomes:
measure: Prediction of difficult intubation
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Al Corniche Hospital
Study officials:
affiliation: King Khaled Eye Specialist Hospital
name: Waleed Riad, MD, AB, SB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06019312: L. Plantarum 299v and Gut Microbiome, Diarrhoea, and Clostridioides Difficile Infection in Colorectal Cancer Patients
Official title: The Impact of Lactobacillus Plantarum 299v in Combination With Inulin on Gut Microbiome, Chemotherapy and Radiotherapy-induced Diarrhoea, and Clostridioides Difficile Infection in Colorectal Cancer Patients in Periooperative Period
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Clostridioides Difficile Infection
Diarrhea
Keywords: Lactobacillus plantarum 299v
Probiotics
Colorectal Cancer
Clostridioides difficile
Diarrhea
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Colorectal cancer in periooperative period patients (n=60) will be enrolled to this study. Participants will be divided into 4 groups as follows:

* group 1 (n=15) will receive 2 capsules (per day) of L. plantarum 299v L. plantarum 299v (Sanprobi IBS®) for 4 weeks
* group 2 (n=15) will receive L. plantarum 299v (2 capsules per day) and inulin (4 g) for 4 weeks
* group 3 (n=15) will receive placebo (2 capsules per day) and inulin (4 g) for 4 weeks
* group 4 (n=15) will receive placebo (2 capsules per day) for 4 weeks


Eligibility criteria: Inclusion Criteria:

* age ≥18 oraz ≤65
* patients with colorectal cancer prior to surgical treatment
* qualification to surgery
* the treatment with chemotherapy and radiotherapy in preoperative period
* an appropriate swallowing
* patients agreement to take part in this study

Exclusion Criteria:

* the presence of other cancers than colorectal cancer
* inflammatory bowel diseases
* dysphagia
* intake of antibiotics, proton pump inhibitors, probiotics, and synbiotics 3 months befor taking part in this study

Primary outcomes:
measure: gut microbiota composition
timeFrame: 4 weeks
Secondary outcomes:
measure: chemotherapy and radiotherapy-induced diarrhoea
timeFrame: 4 weeks
measure: Clostridioides difficile infection
timeFrame: 6 months
Other outcomes:
Locations:
city: Kościerzyna
country: Poland
facility: Unit of Surgery with Unit of Oncological Surgery in Koscierzyna
Study officials:
References:
Clinical trial NCT00005412: Dietary Antioxidants and Atherosclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Cardiovascular Diseases
Heart Diseases
Carotid Stenosis
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To examine the role of dietary antioxidants in the etiology of atherosclerosis in both sexes and in whites and Blacks.

Detailed description: BACKGROUND:

Atherosclerosis is this nation's leading cause of death for males and females, and Blacks and whites. There is mounting evidence that the oxidation of blood low density lipoproteins (LDL) plays an important role in the pathogenesis of this disease. LDL oxidation can be prevented by several dietary antioxidants, in particular, vitamin C, vitamin E, and beta-carotene. There is preliminary evidence that dietary antioxidants may slow the natural history of atherosclerosis in humans. Until now studies in this area have included predominantly white males with symptomatic disease.

DESIGN NARRATIVE:

The case-control study used data collected in ARIC to test the hypothesis that individuals in the lowest quintile of vitamin C, vitamin E and carotenoid consumption were at higher risk of asymptomatic atherosclerosis than those consuming greater amounts. Antioxidant intake was assessed by a validated food frequency questionnaire and a diet supplement survey. Cases were those with asymptomatic carotid artery atherosclerosis as determined by B-mode ultrasonography. Controls were those without evidence of carotid artery atherosclerosis. Secondary analyses determined which sex-race subgroups were at particular risk due to low antioxidant consumption.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kritchevsky SB, Shimakawa T, Tell GS, Dennis B, Carpenter M, Eckfeldt JH, Peacher-Ryan H, Heiss G. Dietary antioxidants and carotid artery wall thickness. The ARIC Study. Atherosclerosis Risk in Communities Study. Circulation. 1995 Oct 15;92(8):2142-50. doi: 10.1161/01.cir.92.8.2142.
citation: Kritchevsky SB, Tell GS, Shimakawa T, Dennis B, Li R, Kohlmeier L, Steere E, Heiss G. Provitamin A carotenoid intake and carotid artery plaques: the Atherosclerosis Risk in Communities Study. Am J Clin Nutr. 1998 Sep;68(3):726-33. doi: 10.1093/ajcn/68.3.726.
Clinical trial NCT03571412: Antidepressive Effect on 5 Herz (Hz) rTMS Over Dorsomedial Prefrontal Cortex and Left Dorsolateral Prefrontal Cortex
Official title: Comparative of Antidepressive Effect on 5Hz rTMS on Dorsomedial Prefrontal Cortex and Left Dorsolateral Prefrontal Cortex
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Depression
Major Depressive Disorder
Lead sponsor: Universidad Autonoma de Queretaro
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The purpose to this study is to valuate the clinical effects of 5Hz rTMS over Left Dorsolateral Prefrontal Cortex and Dorsomedial Prefrontal Cortex
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS) over Left Dorsolateral Prefrontal Cortex and Dorsomedial Prefrontal Cortex on Major Depressive Disorder (MDD).

Detailed description: Major Depressive Disorder (MDD) affects a significant percentage of the national population (17-20%) in 2:1 ratio in women compared to men. Repetitive Transcranial Magnetic Stimulation (rTMS) is an effective neuromodulation technique for the treatment of Major Depressive Disorder and it has demonstrated favorable clinical effects when applied over the Left Dorsolateral Prefrontal Cortex (LDLPFC); however there is evidence that other areas of the prefrontal cortex such as the Dorsomedial Prefrontal Cortex (DMPFC) could be ideal for rTMS treatment targets during the presence of MDD, given its association with deficient cognitive processes during the course of the illness. There is also evidence of the use of 5Hz frequency with the same clinical effectiveness from other frequencies such as 10 Hz and 20 Hz when applied to the LDLPFC. However, there are no current research that have addressed the use of this frequency on DMPFC.

Eligibility criteria: Inclusion Criteria:

* 18-45 years old.
* Meet DSM 5 (Diagnostic and Statistical Manual, 5 edition) diagnostic criteria for Major Depressive Disorder.
* Score \>17 in Hamilton Depression Rating Scale.

Exclusion Criteria:

* Subjects with diagnose of Psychotic Depression, Schizophrenia, Bipolar Disorder, Post Traumatic Stress Disorder.
* Subjects with epilepsy or presence of paroxysms during the EEG.
* Subjects with previous history of traumatic brain injury, metal plates in the skull, cochlear devices, infusion devices such as insulin pumps.

Primary outcomes:
measure: Changes in depressive symptoms evaluated by Hamilton Depressive Rating Scale (HADRS)
timeFrame: 3 weeks
Secondary outcomes:
measure: Changes in depressive symptoms evaluated by Montgomery-Asberg Depressive Rating Scale (MADRS)
timeFrame: 3 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Autónoma de Querétaro
name: Julian Reyes, PhD
role: STUDY_DIRECTOR
References: