louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01420341: Co-trimoxazole as Maintenance Therapy for Melioidosis
Official title: A Comparison Between 12 vs. 20 Weeks of Co-trimoxazole as Maintenance Therapy for Melioidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Melioidosis
Keywords: Melioidosis
Co-trimoxazole
Relapse
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2011-08-19
Enrollment: 667
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomised, open-labelled, controlled trial to compare the efficacy and effectiveness on relapse-free rate of 12-week versus 20-week oral eradication treatment of melioidosis. The study population includes 800 patients with culture-confirmed melioidosis whom 12 weeks of oral eradication therapy have been completed with or without intravenous intensive antibiotics. Patients will be randomised to either stop the eradication treatment or continue current oral treatment for 8 more weeks. The study aim to optimise the regimen used to treat melioidosis for better compliance and reducing unnecessary use of antibiotics.

Detailed description: Planed interim analysis will be conducted when the patient enrollment reaches 600 cases for evaluating safety and futility of the study.

Eligibility criteria: Inclusion Criteria:

1. Age \> 15 years
2. Culture-confirmed melioidosis
3. Currently on oral co-trimoxazole for 12(+2) weeks without any clinical evidence of active melioidosis
4. High likelihood of completing at least 6 months follow up
5. Willingness to participate in the study and written, informed consent obtained from the patient

Exclusion Criteria:

1. Pregnancy or breast feeding
2. Contraindications to TMP-SMX: G6PD, severe adverse reactions grade 3-4 occurring during first 12 weeks of treatment
3. Relapse melioidosis with at least 2 year symptom free period from last episode

Primary outcomes:
measure: 1-year non relapse rate
timeFrame: 1 year
Secondary outcomes:
measure: Clinical Recurrence
timeFrame: 1 year
measure: Treatment failure
timeFrame: 9 weeks
measure: Mortality
timeFrame: 1 year
measure: Adverse Drug Reactions
timeFrame: 9 weeks
measure: Drug compliance
timeFrame: 12 or 20 weeks
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Khon Kaen Univerisity
Study officials:
affiliation: Khon Kaen Univerisity
name: Siriluck Anunnatsiri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anunnatsiri S, Chaowagul W, Teparrukkul P, Chetchotisakd P, Tanwisaid K, Khemla S, Narenpitak S, Pattarapongsin M, Kongsawasd W, Pisuttimarn P, Thipmontree W, Mootsikapun P, Chaisuksant S, Chierakul W, Day NPJ, Limmathurotsakul D. A Comparison Between 12 Versus 20 Weeks of Trimethoprim-sulfamethoxazole as Oral Eradication Treatment for Melioidosis: An Open-label, Pragmatic, Multicenter, Non-inferiority, Randomized Controlled Trial. Clin Infect Dis. 2021 Dec 6;73(11):e3627-e3633. doi: 10.1093/cid/ciaa1084.
Clinical trial NCT03404141: Stress Reduction Therapy for Pregnant Women
Official title: Psychological Therapy to Reduce Levels of Stress Among Pregnant Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prenatal Stress
Keywords: Stress
pregnancy
psychological therapy
cortisol
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prenatal stress is associated with negative outcomes such as postpartum depression, prematurity or neurodevelopmental delays.

The aim of this study is to implement a psychological therapy to reduce stress during pregnancy.

Detailed description: Objective: To assess whether the group of pregnant women have lower levels of stress after attending the psychological therapy than the group attending parent craft classes.

The cognitive-behavioural therapy to reduce stress will be held in 10 sessions (1 per week) as follows:

First session: General information about pregnancy. Pregnant women will describe what can they do to reduce stress levels.

Second session: Breathing techniques and talk about how last week went. Third session: Muscle relaxation and guided imagination techniques Fourth session: Cognitive restructuring. Being able to detect thoughts and feelings Fifth session: Detect cognitive distortions Sixth session: Cognitive restructuring Seventh session: Time management Eighth session: Problems solving Ninth session: Assertively and social skills Tenth session: How to ask for help when needed and learning to say "No".

Eligibility criteria: Inclusion Criteria:

* Low risk Pregnant women
* Gestational age between 10-27 weeks
* Proficiency in the Spanish language

Exclusion Criteria:

* Corticoids treatment
* Gestational Diabetes
* Psychological diagnosed

Primary outcomes:
measure: Change in hair cortisol levels
timeFrame: Baseline, and 3 months
Secondary outcomes:
measure: Change in Perceived Stress Scale (PSS)
timeFrame: Baseline, and 3 months
measure: Change in Prenatal Distress Questionnaire (PDQ)
timeFrame: Baseline, and 3 months
measure: Change in Symptoms Checklist 90 Revised (SCL-90-R)
timeFrame: Baseline, and 3 months
measure: Change in Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: Baseline, and 3 months
Other outcomes:
measure: Infant neurodevelopment
timeFrame: 6 months of age
Locations:
city: Churriana de la vega
country: Spain
facility: Granada
state: Granada
Study officials:
affiliation: Universidad de Granada
name: Borja Romero
role: PRINCIPAL_INVESTIGATOR
References:
citation: Romero-Gonzalez B, Puertas-Gonzalez JA, Strivens-Vilchez H, Gonzalez-Perez R, Peralta-Ramirez MI. Effects of cognitive-behavioural therapy for stress management on stress and hair cortisol levels in pregnant women: A randomised controlled trial. J Psychosom Res. 2020 Aug;135:110162. doi: 10.1016/j.jpsychores.2020.110162. Epub 2020 May 26.
Clinical trial NCT01438541: A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration
Official title: A Multi-centre, Post CE-mark, Open Study to Evaluate the Performance of Thin Self-adherent Dressing Coated With a Soft Silicone Layer on Subjects With High Risk of Category 2 or Above Pressure Ulceration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pressure Ulcer
Keywords: No skin breakdown
Prevention
protection of the skin
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2011-09-22
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will be conducted in approximately 26 subjects in UK to yield 20 evaluable subjects at 3 sites with approximately 5-10 subjects/site. Subjects with acute vascular, surgical and orthopaedic medical care in the elderly admission, with a high risk to develop skin breakdown or subjects with category 1 pressure ulcer can be enrolled in this investigation.

The rational for this study is to evaluate the potential for Window in the prevention of pressure ulcers because of its ability to reduce shear and friction forces.


Eligibility criteria: Inclusion Criteria:

1. acute vascular, surgical, orthopaedic, medical or care of the elderly admission
2. aged 18 years or over
3. have an expected total length of stay of 5 or more days
4. at high risk of PU development due to one or more of the following

   * bedfast/chairfast AND completely immobile/very limited mobility
   * category 1 PU on any pressure area skin site (see appendix G)
5. give their written, informed consent to participate
6. expected to be able to comply with follow-up schedule

Exclusion Criteria:

1. risk area which doesn't fit the dressing size 6\*7cm, 10\*12 cm and 15\*20cm
2. subject has category 2-4 pressure ulcer
3. subject has documented skin disease at time of enrolment, as judged by the investigator
4. known allergy/hypersensitivity to any of the components in the dressing
5. previous enroled in the present study
6. subject included in other ongoing clinical investigation at present, as judged by the investigator

Primary outcomes:
measure: Erythema ( No/Yes)
timeFrame: 14 days
Secondary outcomes:
measure: Overall Experience of Use of the Dressing
timeFrame: 14 days
measure: Evaluate the Dressing Shape
timeFrame: 14 days
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Wakefield
country: United Kingdom
facility: The Mid Yourkshire Hospitals NHS Trust
Study officials:
affiliation: University Hospital Birmingham NHS
name: Carol Dealey, BSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00817141: Urinary Catheter and Fast-track Surgery
Official title: Is Urinary Catheter Necessary After Fast-Track Colonic Surgery?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Complications
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2009-01-06
Enrollment: 60
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: Patients scheduled for Fast Track colonic surgery

Brief summary: Urinary catheter was placed during several days after colonic surgery. Nevertheless, it is probably unnecessary after Fast-Track colonic surgery. No prospective data permit to confirm it.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for Fast Track colonic surgery

Exclusion Criteria:

* Urinary pathology

Primary outcomes:
measure: Incidence of urinary retention necessitating catheterisation
timeFrame: 72 hours
Secondary outcomes:
measure: Other urinary complications and modification of the Fast Track protocol
timeFrame: 4 days
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: St Luc Hospital
Study officials:
References:
Clinical trial NCT01854541: Visual Management for the Radiotherapy Process
Official title: Visual Management for the Radiotherapy Process
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Cancer
Radiotherapy
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
Collaborators: name: Maastro Clinic, The Netherlands
First posted: 2013-05-15
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated with radiotherapy

Brief summary: The Visual Management for Radiotherapy Practice (VMRTP) aims to analyze, predict, visualize and shorten the waiting times for radiotherapy patients. The hypothesis is that this can be done by the introduction of models that can predict a patient being at risk for waiting too long as well as visual management tools that visualize the radiotherapy process.

Detailed description: In a retrospective cohort of radiotherapy patients, time stamps of various steps in the radiotherapy process (diagnosis, multi-disciplinary board, referral, intake, simulation, treatment planning, quality control, first fraction of radiotherapy) will be collected. These will be combined with patient, tumor and patient-process (e.g. referring physician, treating physician, busy-at-the-time, referring hospital) related features. Based on these a predictive model will be learned that can estimate the probability at various stages of the process that the patient waits too long. Visual management will be developed that can visualize the predicted waiting time.

Process interventions aimed at reducing waiting times will be tested prospectively.

Eligibility criteria: Inclusion Criteria:

Patients receiving radiotherapy

Exclusion Criteria:

Patients not receiving radiotherapy

Primary outcomes:
measure: referral and first day of radiotherapy
timeFrame: 3 months
Secondary outcomes:
measure: Diagnosis and first day of radiotherapy
timeFrame: 3 months
measure: multi-disciplinary board and first day of radiotherapy
timeFrame: 3 months
measure: intake and first day of radiotherapy
timeFrame: 3 months
measure: simulation and first day of radiotherapy
timeFrame: 3 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: MAASTRO clinic
Study officials:
References:
Clinical trial NCT04151641: Mangoselect®: Characterization, Pharmacokinetics and Bioavailability of Xanthone Metabolites
Official title: Evaluation of Absorption and Metabolism of Phenolic Compounds From Mangoselect®, an Extract of Mangosteen. Comparison of Two Versions During a Randomized, Double-blinded and Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Lead sponsor: Fytexia
Sponsor class: INDUSTRY
First posted: 2019-11-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The aim of this study is to compare pharmacokinetics and bioavailability of phenolic compounds, mainly xanthones, from a mangosteen extract, either ingested in a dry powder form or in an encapsulated form. Absorption and metabolism will be determined by measuring urinary excretion of phenolic metabolites and blood metabolic profile over 72 hours by means of High Pressure Liquid Chromatography (HPLC) coupled with tandem mass spectroscopy.

The design of this study is a cross-over, double-blind and randomized trial on 10 healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent study
* Stated willingness to comply with all the study procedures and availability for the duration of the study
* Male and female
* Normal BMI range (18.50-24.99)
* In good general health as evidenced by medical history
* Ability to take oral medication and be willing to adhere to lifestyle considerations

Exclusion Criteria:

* Current use of any medication or food supplement
* Pregnancy or lactation
* Known allergic reaction to mangosteen
* Metabolic disorders or any kind of disease
* Currant smoker

Primary outcomes:
measure: Difference in urinary metabolites excretion between MNGDPF (Mangoselect dry powder form) and MNGEF (Mangoselect encapsulated form)
timeFrame: Baseline (post-ingestion), 0-3 hours, 3-6 hours, 6-10 hours, 10-14 hours, 14-24 hours, 24-48 hours, 48-72 hours
Secondary outcomes:
measure: Difference in plasma concentration of phenolic metabolites between MNGDPF and MNGEF
timeFrame: Baseline (post-ingestion), 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 19 hours, 24 hours, 48 hours
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: UCAM
Study officials:
affiliation: UCAM
name: Pedro Alcaraz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05255341: Clinical and Radiographic of the Effect of Socket Preservation Using the Roll Pedicle Connective Tissue Graft With Bovine Bone: A Case Series Trial.
Official title: Clinical and Radiographic Evaluation of the Effect of Socket Preservation Using the Roll Pedicle Connective Tissue Graft With Bovine Bone: A Case Series Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Socket Preservation
Keywords: socket preservation
vascularized interpositional connective tissue graft
alveolar ridge preservation techniques
bovine bone graft
roll pedicle graft
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 8
Sex: ALL
Minimum age (years): 27
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: After tooth extraction, the residual alveolar ridge generally provides limited bone volume because of ongoing, progressive bone resorption. Healing events within post-extraction sockets reduce the dimensions of the socket over time. Therefore, socket preservation became an indispensable procedure as well as fundamental to prevent bone loss following tooth extraction. Preservation, by the name, is the maintenance of the socket, which is essentially the height and width of the gap that is left after the tooth is removed. It is done by placing a graft material or scaffold immediately into the socket of an extracted tooth to presto preserve bone height, width and density

Detailed description: Investigator evaluate the clinical and radio graphic effect of roll pedicle connective tissue graft as a barrier membrane together with bovine bone in alveolar ridge preservation in extraction sockets.

Eligibility criteria: Inclusion Criteria:

* • patients with healthy systemic condition.

  * Adult patients ˃ 18 years old.
  * hopeless teeth that need tooth or root extraction in the maxillary esthetic zone.
  * Alveolar socket Grade I and II.
  * Normal platelet counts according to complete blood count (CBC) test done in the screening stage.

Exclusion Criteria:

* Acute infection at the extraction site

  * Smokers ˃ 10 cigarettes / day.
  * Medications that may interfere with wound healing
  * History of treatment with bisphosphonates.
  * History of allergic reaction

Primary outcomes:
measure: width of alveolar bone
timeFrame: changes in the Width of alveolar bone were measured at 3& 5 mm at baseline,3 months and 6 months
Secondary outcomes:
measure: gingival thickness
timeFrame: changes in the gingival thickness were measured at 3 & 5mm at (baseline,3 months and 6 months)
measure: height of the alveolar crest
timeFrame: changes in height of alveolar crest were measured at baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Dentistry -Cairo University
Study officials:
affiliation: cairo university- faculty of dentistry
name: noha magdy salem amin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03626441: The Effect of Ginger on the Incidence of Postoperative Nausea and Vomiting
Official title: An Evaluation of the Effectiveness of a Single Dose of Preoperative Ginger on the Incidence of Postoperative Nausea and Vomiting in Patients Undergoing Elective Gynaecological Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Nausea and Vomiting
Keywords: Postoperative Nausea and Vomiting
Ginger
Lead sponsor: The University of The West Indies
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quadruple, blind randomized, controlled trial
Primary purpose: PREVENTION

Brief summary: This study evaluates the effectiveness of ginger on the incidence of postoperative nausea and vomiting in patients undergoing gynaecological surgery. Half the patients were given an oral dose of ginger preoperatively and half received placebo.

Detailed description: Postoperative nausea and vomiting (PONV) commonly complicate surgery and may lead to a prolonged length of stay in hospital, increased complication rates and decreased patient satisfaction. Gynaecological surgery is considered high risk for PONV.

Ginger is a cheap, widely available and safe natural product in Jamaica and has been found to reduce the incidence of Nausea and vomiting in other clinical situations, such as in pregnancy. It is believed to act via the inhibition of serotonergic receptors.

Eligibility criteria: Inclusion Criteria:

* Age 18 or above
* Undergoing elective intra-abdominal, gynaecological surgery

Exclusion Criteria:

* Allergy to ginger, ginger by-products or cornstarch
* Gastroesophageal reflux disease (GERD)
* Allergy to any of the Anaesthesia Agents
* Inability to swallow capsules.
* psychiatric illness which prevents patients giving informed consent.
* Psychological which prevents patients giving informed consent.

Primary outcomes:
measure: Incidence of post operative nausea or vomiting
timeFrame: 12 hours after surgery
Secondary outcomes:
measure: Severity of post operative Nausea and vomiting
timeFrame: 12 hours after surgery
measure: Severity of post operative Nausea and vomiting
timeFrame: 24 hours after surgery
measure: Severity of post operative Nausea and vomiting
timeFrame: 48 hours after surgery
measure: Severity of post operative Nausea and vomiting
timeFrame: 12 hours after surgery
measure: Severity of post operative Nausea and vomiting
timeFrame: 24 hours after surgery
measure: Severity of post operative Nausea and vomiting
timeFrame: 48 hours after surgery
measure: Patient satisfaction
timeFrame: 48 hours post surgery
Other outcomes:
Locations:
city: Kingston
country: Jamaica
facility: University of the West Indies
state: Kng 7
Study officials:
affiliation: UWI, Faculty of medical sciencces
name: Hyacinth Harding, DM
role: PRINCIPAL_INVESTIGATOR
affiliation: UWI, Faculty of medical sciencces
name: Andrea Myers, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03358641: The Relationship Between Physical Activity and Radiographic Osteoarthritis Worsening
Official title: The Relationship Between Physical Activity and Radiographic Osteoarthritis Worsening: Wuchuan Osteoarthritis Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis, Knee
Keywords: exercise
physical activity
radiographic osteoarthritis
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 1200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People, over 50 years old, in a rural area in Northern China (Wuchuan, Inner Mongolia)

Brief summary: Wuchuan Osteoarthritis Study is a population-based longitudinal study of natural history of knee osteoarthritis and its risk factors. At baseline and follow-up visits, IPA-Q questionnaire and a radiographs at tibiofemoral (TF) joints will be taken in order to assess the relationship between physical activity and radiographic osteoarthritis worsening.

Detailed description: 1025 residents aged ≥ 50 years will be recruited using door-to-door enumeration in randomly selected rural communities in Wuchuan, China, and will be followed in 3 years. At baseline and follow-up visits, subjects will complete a home interview (including, but not limited to, socio-demographic factors, physical activity level using IPA-Q questionnaire,WOMAC questionnaire) and have a weight-bearing posteroanterior semiflexed view of radiographs at tibiofemoral (TF) joints. Radiographic osteoarthritis (ROA) worsening for a knee is defined if its Kellgren and Lawrence (K/L) grade increases by at least 1 grade except for the change from 0 to 1 during follow-up. The relationship between level of physical activity and ROA worsening will be assessed.

Eligibility criteria: Inclusion Criteria:

1. people aged 50 or over
2. Wuchuan permanent resident population

Exclusion Criteria:

1. patients with rheumatoid arthritis
2. the disabled
3. patients with mental disorders
4. laid up for malignant tumor
5. people who live or work outside for more than half a year

Primary outcomes:
measure: worsening of radiographic osteoarthritis
timeFrame: 3 years after enrollment
Secondary outcomes:
measure: The Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: 3 years after enrollment
Other outcomes:
Locations:
Study officials:
affiliation: arthritis clinic and research center
name: Jianhao Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: