louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01247181: Cameroon Mobile Phone SMS Trial
Official title: Improving Adherence to HAART Using Mobile Phone Text Messages
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence
HIV
Keywords: compliance
observance
mobile phone
SMS
text message
ARV
HAART
AIDS
Lead sponsor: Yaounde Central Hospital
Sponsor class: OTHER_GOV
Collaborators: name: CIHR Canadian HIV Trials Network
First posted: 2010-11-24
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators hypothesize that sending weekly motivational text messages to people infected with HIV will encourage them to take their medication, compared to usual care.


Eligibility criteria: Inclusion Criteria:

* On HAART for at least 1 month
* 21 years or more
* Owns a mobile phone
* Can read text messages

Exclusion Criteria:

* On HAART for less than 1 month
* Aged less than 21 years

Primary outcomes:
measure: Adherence
timeFrame: Change from baseline at 6 months
Secondary outcomes:
measure: Weight
timeFrame: Change from baseline at 6 months
measure: Body Mass Index
timeFrame: Change from baseline at 6 months
measure: CDC classification
timeFrame: Change from baseline at 6 months
measure: WHO Classification
timeFrame: Change from baseline at 6 months
measure: Mortality
timeFrame: 6 months
measure: CD4 count
timeFrame: Change from baseline at 6 months
measure: Viral load
timeFrame: Change from baseline at 6 months
measure: Quality of life
timeFrame: Change from baseline at 6 months
Other outcomes:
Locations:
city: Yaounde
country: Cameroon
facility: Yaounde Central Hospital Accredited Treatment Centre
state: Centre
Study officials:
affiliation: Centre for the Development of Best Practices in Health
name: Lawrence Mbuagbaw, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for the Development of Best Practices in Health
name: Pierre Ongolo-Zogo, MD, BSc
role: STUDY_DIRECTOR
References:
citation: Mbuagbaw L, Thabane L, Ongolo-Zogo P, Lester RT, Mills EJ, Smieja M, Dolovich L, Kouanfack C. The Cameroon Mobile Phone SMS (CAMPS) trial: a randomized trial of text messaging versus usual care for adherence to antiretroviral therapy. PLoS One. 2012;7(12):e46909. doi: 10.1371/journal.pone.0046909. Epub 2012 Dec 6.
citation: Mbuagbaw L, Thabane L, Ongolo-Zogo P, Lester RT, Mills E, Volmink J, Yondo D, Essi MJ, Bonono-Momnougui RC, Mba R, Ndongo JS, Nkoa FC, Ondoa HA. The Cameroon mobile phone SMS (CAMPS) trial: a protocol for a randomized controlled trial of mobile phone text messaging versus usual care for improving adherence to highly active anti-retroviral therapy. Trials. 2011 Jan 7;12:5. doi: 10.1186/1745-6215-12-5.
Clinical trial NCT05335681: The Effects of Warm Application in Birth on Birth Pain, Birth Satisfaction and Birth Results
Official title: Midwife Öznur Hayat Öktem
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor
Pregnancy
Active Phase
Keywords: warm shower
labor pain
birth Satisfaction
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled
Primary purpose: SUPPORTIVE_CARE

Brief summary: The use of non-pharmacological methods in labor pain is very important in order to improve the birth process, increase comfort and provide relaxation. The role of midwives, acting as patient advocate is to maintain comfort throughout the birth process. In order to do this, she should know very well the non-pharmacological methods to be applied to the pregnant woman and choose the most appropriate one. Applying a warm shower, which is one of the non-pharmacological methods; the uterus Increases perfusion, makes labor painless felt, increases the release of oxytocin, and decreases the release of stress hormones.

In addition, while reducing the intervention rates, it improves birth and newborn outcomes and affects positively. Purpose of the research; labor pain of warm shower application, labor to evaluate the effect on satisfaction and birth outcomes.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and 35,
* Between 37 and 42 weeks of pregnancy,
* Planning a normal birth,
* Does not have a chronic health problem,
* At least 20 minutes of non-stress test (NST) tracing is reactive,
* Those without premature rupture of membranes (EMR) or those with PROM Not exceeding 6 hours from the opening time of the membranes,
* Speaking Turkish and not having any communication barriers,
* Including pregnant women who voluntarily accepted to participate in the study will be.

Exclusion Criteria:

* The mother's refusal to be involved in the study
* The use of analgesic methods during the birth process,
* Abnormal changes in fetal heartbeats,
* Unexpected complications (Dizziness, fatigue)
* Pregnant women who decided to have an emergency cesarean section

Primary outcomes:
measure: Labor Pain
timeFrame: Baseline (Before the intervention)
measure: Labor pain
timeFrame: 10 minutes after the intervention
measure: Labor pain
timeFrame: 20 minutes after the intervention
Secondary outcomes:
measure: Birth satisfaction
timeFrame: Pregnant women in both groups will be visited by the researcher in the postpartum service within the first 12 hours postpartum and BSC will be applied.
Other outcomes:
Locations:
city: Karabük
country: Turkey
facility: Öznur Hayat Öktem
Study officials:
References:
Clinical trial NCT02159781: Effect of Periodontal Treatment on Salivary Biomarkers
Official title: Effect of Periodontal Treatment on Salivary Biomarkers.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Periodontitis
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
First posted: 2014-06-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators plan to recruit 40 healthy patients referred to the unit of Periodontology, diagnosed with generalized moderate - severe chronic periodontitis.

treatment will include 4 - 6 sessions of scaling + root planning, oral hygiene instructions and motivation.

Whole saliva will be collected at intake and 8 - 14 weeks post periodontal treatment.

Saliva will be analyzed for trans locator protein. Study hypothesis: Periodontal treatment has an affect on saliva components.


Eligibility criteria: Inclusion Criteria:

* healthy patients
* moderate - sever chronic periodontitis

Exclusion Criteria:

* systemic disease
* pregnancy
* subjects under the age of 18

Primary outcomes:
measure: Whole saliva & translocator protein (TSPO)
timeFrame: Intake of patients than 8 - 12 weeks after periodontal treatment (scaling & root planning)
Secondary outcomes:
measure: Periodontal measurements (periodontal pocket depth, bleeding on probing & clinical attachment level)
timeFrame: Intake 8 - 12 weeks post periodontal treatment (scaling & root planning)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00090181: Study of MK0663 in Patients With Chronic Low Back Pain (0663-806)(COMPLETED)
Official title: A Double-Blind, Parallel-group, 4-Week Trial to Assess the Efficacy and Safety of Etoricoxib 60 mg and Diclofenac 150 mg in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Low Back Pain
Keywords: Arcoxia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-08-27
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of MK0663 for the treatment of chronic low back pain and to investigate the overall safety and tolerability over four weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Male and female patients 18 years of age or older, who have Chronic Low Back Pain after the discontinuation of their previous medication for their condition.
* Patients should have at least 3 months of Low Back Pain.

Primary outcomes:
measure: Lower back pain intensity
measure: Safety and tolerability
Secondary outcomes:
measure: Disability questionnaire
measure: Patient global assessment of response to therapy
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Zerbini C, Ozturk ZE, Grifka J, Maini M, Nilganuwong S, Morales R, Hupli M, Shivaprakash M, Giezek H; Etoricoxib CLBP Study Group. Efficacy of etoricoxib 60 mg/day and diclofenac 150 mg/day in reduction of pain and disability in patients with chronic low back pain: results of a 4-week, multinational, randomized, double-blind study. Curr Med Res Opin. 2005 Dec;21(12):2037-49. doi: 10.1185/030079905X75069.
Clinical trial NCT05305781: Study of the Determinants of Emergency Dialysis in Reunion Island
Official title: Prevalence and Epidemiology of Extra Renal Replacement Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dialysis
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We plan to include 200 newly dialysis patients in a year from the dialysis centres covering the major part of the Reunion Island.

Brief summary: Among patients followed by nephrologists, the frequency of emergency dialysis starts' and their social and clinical determinants are not well known, especially in Reunion Island. In this context, we aim to study and understand the determinants of emergency dialysis initiation. For Reunion Island, the data remain very fragmented.


Eligibility criteria: Inclusion Criteria:

* Adult patient ≥18 years
* Starting dialysis in a dialysis centre in Réunion Island
* Having expressed their non-opposition or Emergency inclusion (non-opposition collected afterwards)

Exclusion Criteria:

* Under legal protection (safeguard of justice, guardianship)
* Unable to answer questionnaires

Primary outcomes:
measure: Characteristics of emergency analysis
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Denis
country: Réunion
facility: CHU de la Réunion
Study officials:
References:
Clinical trial NCT05953181: Statistical Analysis Plan for the SANO-trial: Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Active Surveillance for Oesophageal Cancer
Official title: Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Active Surveillance for Oesophageal Cancer (SANO-trial): a Phase-III Stepped-wedge Cluster Randomised Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Esophageal Cancer
Active Surveillance
Neoadjuvant Chemoradiotherapy
Surgical Oncology
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 776
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An active surveillance approach is proposed after completion of neoadjuvant chemoradiotherapy (nCRT) for carcinoma of the oesophagus. In this SANO (i.e. Surgery As Needed for Oesophageal cancer) approach, surgical resection is offered only to patients in whom a locoregional regrowth is highly suspected or proven, without distant dissemination. Such an organ-preserving strategy can have great advantages, but is only justified if long-term survival is non-inferior to that of the current standard trimodality approach comprising neoadjuvant chemoradiotherapy followed by standard surgery. The aim of this study is to assess the (cost-)effectiveness (including non-financial costs and survival) of active surveillance for patients with squamous cell- or adenocarcinoma of the oesophagus or oesophago-gastric junction.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent or are planned to undergo neoadjuvant chemoradiotherapy according to CROSS and are planned to undergo potentially curative surgical resection for histologically proven oesophageal or junctional squamous cell carcinoma or adenocarcinoma are eligible. Whenever pathology is inconclusive but a multidisciplinary expert group concludes oesophageal carcinoma because of radiologically or endosonographically highly suspected lesions, patients are eligible for the study.
* Age ≥18;
* Written, voluntary, informed consent.

Exclusion Criteria:

* Language difficulty, dementia or altered mental status prohibiting the understanding and giving of informed consent and to complete quality of life questionnaires;
* Non-FDG-avid tumour at baseline PET-CT scan;
* Initial treatment with endoscopic resection.

Primary outcomes:
measure: Overall survival
timeFrame: the interval between the moment of achieving cCR (i.e. the moment the patient will start the intervention) and death or last follow-up, with a minimal follow-up of two years after reaching cCR.
Secondary outcomes:
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC, University Medical Center
state: Zuid-Holland
Study officials:
References:
Clinical trial NCT05732181: The Role of 5% Lidocaine Patches in the Pain Control of Hepatocellular Carcinoma Patients Receiving Radiofrequency Ablation
Official title: The Role of 5% Lidocaine Patches in the Pain Control of Hepatocellular Carcinoma Patients Receiving Radiofrequency Ablation: A Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Post Ablation Syndrome
Keywords: Hepatocellular carcinoma
Radiofrequency ablation
Lidocaine patch
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: This study aims to test whether 5% lidocaine patches can reduce Radiofrequency ablation-induced pain. Methods: The study will enroll patients with hepatocellular carcinoma and schedule a radiofrequency ablation procedure. 200 patients will be invited to allocate randomly into study or control groups: pretreatment with a 5% lidocaine patch (LidotopⓇ) (Group A); pretreatment with a placebo patch (Group B); The skin patch is applied before Radiofrequency ablation (RFA) while admission, and is changed every day till discharge. Pain severity is evaluated by a visual analog scale using a 10-point scale recorded by a study nurse before RFA and after the procedure. The demographic data, hepatocellular carcinoma characteristics, analgesics usage, patient satisfaction with pain control, and visual analog scale will be compared between the two groups. Anticipated results: Pretreatment with 5% lidocaine patches is an effective and straight method of reducing Radiofrequency ablation-induced pain to reduce analgesics usage and improve patient satisfaction with pain control.


Eligibility criteria: Inclusion Criteria:

1. Adults diagnosed with liver cancer (HCC) by a physician and eligible for radiofrequency cautery (RFA).
2. Age is \> = 18 years.
3. Whether there is cirrhosis combined with cirrhosis, the child-pugh score of those with cirrhosis must score \< 8 points.
4. Communicative and able to express pain sensations.

Exclusion Criteria:

1. Those who are allergic to Lidocaine.
2. Those who suffer from skin diseases or have wounds on the abdomen that cannot be patched.

Primary outcomes:
measure: Pain severity
timeFrame: two days to three days.
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
References:
Clinical trial NCT00199381: An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001
Official title: An Open-Label Multicenter Study of the Continued Safety of Istradefylline (KW-6002) In Subjects With Parkinson's Disease Who Have Recently Completed One Year of Treatment With Istradefylline.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
levodopa
end of dose wearing off
OFF time
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Kyowa Kirin Co., Ltd.
First posted: 2005-09-20
Enrollment: 504
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an, open-label, long-term safety extension for patients in North America who have completed the prior istradefylline study 6002-INT-001.

Detailed description: Patients with Parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind study 6002-INT-001 are eligible to enter into this long-term open safety study with a starting istradefylline dose of 20 or 40mg per day.

Eligibility criteria: Inclusion Criteria:

* Completion of study 6002-INT-001
* Not of childbearing potential

Exclusion Criteria:

* Cancer within 5 years of enrollment
* ALT/AST levels \> 2.5 times ULN

Primary outcomes:
measure: Safety as Measured by Adverse Events
timeFrame: Every 2 months up to 32 months
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Kyowa Pharmaceutical Inc.
state: New Jersey
Study officials:
affiliation: Kyowa Kirin, Inc.
name: Neil Sussman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01899781: Prophylactic Antibiotic Treatment for Hand Lacerations Involving Flexor and/or Extensor Tendon
Official title: Prophylactic Antibiotic Treatment for Hand Lacerations Involving Flexor and/or Extensor Tendon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hand Laceration
Tendon Involved
Clean Laceration
No Bone Involved
Keywords: Lacerations
Tendons
Antobiotic
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2013-07-15
Enrollment: 24
Sex: ALL
Minimum age (years): 13
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators assume that simple hand lacerations involving flexors or extensors tendons, do not require prophylactic antibiotic treatment to prevent wound infection.

Detailed description: Hand lacerations are divided to "complicated" which involves tendons, nerves, bones, and joints, and "simple" which involves only cutaneous and subcutaneous tissue.

prophylactic antibiotic should not be given in a clean simple lacerations, and should be given when a bone is involve (open fracture). But there is not enough data, weather prophylactic antibiotic treatment should be given when only tendons are involved. The investigators will examine 2 groups of 30 patients each with clean hand lacerations involving tendons. One group will be treated with prophylactic antibiotic and the other wont be treated, randomly. The investigators assume that the rate of wound infection wont be different between the 2 groups.

Eligibility criteria: Inclusion Criteria:

* Hand laceration
* Tendon involeved
* Clean laceration
* No bone involved

Exclusion Criteria:

* Pregnant
* Children
* Immunocompremised patients
* "Dirty" lacerations

Primary outcomes:
measure: rate of wound infections
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01343381: Comparison of Heparin Types; Efficacy and Safety
Official title: Anticoagulant Effect and Reversal of Hepalean Compared With PPC Heparin in Patients Undergoing Cardiopulmonary Bypass: a Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Heparin
Coronary artery bypass graft surgery
Anti-coagulation efficacy
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2011-04-28
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Heparin, a blood thinner, is used routinely in Open-heart surgery. Do different brands of this drug have differing clinical effects despite both having exactly the same regulation and marketing specifications?


Eligibility criteria: Inclusion Criteria:

* will be undergoing cardiopulmonary bypass for coronary artery disease
* has provided written informed consent

Exclusion Criteria:

* Allergy or intolerance to Heparin

Primary outcomes:
measure: Feasibility to conduct a larger trial
timeFrame: pre-cardiopulmonary bypass initiation; peri-operative period (in minutes) to 24 hours post-operatively
Secondary outcomes:
measure: ACT after initial dose of heparin
timeFrame: pre-cardiopulmonary bypass initiation; peri-operatively(in seconds)
measure: Total Heparin Dose used
timeFrame: pre-cardiopulmonary bypass initiation to termination of cardiopulmonary bypass; peri-operatively(in minutes)
measure: Coagulation
timeFrame: post-cardiopulmonary inition, at the 45 minute on pump time point; perioperatively to 24 hours post-operatively
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences: Hamilton General Site
name: Kevin H Teoh, MD
role: PRINCIPAL_INVESTIGATOR
References: