louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05107089: Ultrasound Guided Subclavian Vein Cannulation at Emergency Room
Official title: Ultrasound Guided Subclavian Vein Cannulation at Emergency Room , Success Rate and Incidence of Complications
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ultrasound Subclavian Cannulation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient has arrived to the emergency room with sign of hypovolemic shock Or arrested

Brief summary: 1. To observe and report the success rate associated with the use of ultrasound for subclavian vein catheterization.
2. To observe and report the type and complications and any constrains associated with this technique.

Detailed description: Central venous catheterisation is a commonly performed procedure in anaesthesia, critical care, acute and emergency medicine. 1 , the subclavian vein (SCV) has been an important vessel for central venous cannulation.2 The SCV cannulation offers several advantages when compared to the common alternative sites for central venous access. These advantages may include fewer cases of thrombosis, infectious complications, better patient comfort, and increased ability to remain patent in hypovolemic states.3-4 Traditionally, subclavian venous catheterisation has been performed using the landmark technique and because of the complications associated with this technique, it is not commonly performed.1 the complications such as catheter malposition, arterial puncture, hematoma, pneumothorax, hemothorax, and nerve injury.

Eligibility criteria: Inclusion Criteria:

* All patient admitted to emergency room and indicated for central venous catheterization

Exclusion Criteria:

* 1. Any contraindication for central vein cannulation as coagulopathy, hemorrhage from target vessel, suspected proximal vascular injury 2- Age below 18 year

Primary outcomes:
measure: success rate of the ultrasound guided subclavian vein cannulation success rate of the ultrasound guided subclavian vein cannulation Success rate of ultrasound guided of subclavian vein cannulation
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hayashi M, Oshima K. Purification and properties of oxytocinase (cystine amino-peptidase) from monkey placenta. J Biochem. 1976 Aug;80(2):389-96. doi: 10.1093/oxfordjournals.jbchem.a131288.
Clinical trial NCT00239889: Efficacy and Safety of Salmon Calcitonin Nasal Spray in Improving Muscle Strength and Reducing Pain After Forearm Fracture in Postmenopausal Women
Official title: Efficacy and Safety of Salmon Calcitonin Nasal Spray in Improving Muscle Strength and Reducing Pain After Forearm Fracture in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Forearm Fracture
Keywords: Forearm fracture
Postmenopausal women
Pain
Grip strength
Salmon calcitonin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 300
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Calcitonin has been used for many years for treating osteoporosis in postmenopausal women, and it has been shown that calcitonin reduces pain after spine and hip fracture in women with osteoporosis. Therefore, this study assesses the safety and efficacy of salmon calcitonin nasal spray on muscle strength after a forearm fracture, pain, quality of life and fracture healing in postmenopausal women.


Eligibility criteria: Inclusion Criteria:

* Post-menopausal women, aged at least 60 years old
* Having a forearm fracture within the last 3-7 days before treatment
* Fracture is treated with either a plaster cast only, or a cast plus Kirschner wires

Exclusion Criteria:

* Multiple fractures, severe fractures, or the forearm fractured in more than one place
* Nerve damage in the forearm caused by the fracture
* Other conditions which would interfere with the grip strength measurements (e.g. swelling, paralysis, skin diseases or rheumatoid arthritis)

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Grip strength of the injured arm after 24 weeks
Secondary outcomes:
measure: Post fracture pain intensity at rest in the evenings and analgesic consumption over 24 hours at Days 1-7; weeks 2, 3 and 4; the day before cast removal; 1 to 7 days and 2, 4 and 10 weeks after cast removal; and at 24 weeks after enrolment.
measure: Post fracture pain intensity after grip strength assessment at cast removal; at 1, 2, 4 and 10 weeks after cast removal (4-6 weeks after fracture); and at 24 weeks after enrolment.
measure: Incidence of complex regional pain syndrome (CRPS) type 1/reflex sympathetic dystrophy (RSD) at cast removal; at 1, 2, 4 and 10 weeks after cast removal; and at 24 weeks after enrolment.
measure: Grip strength in the injured arm at cast removal and at 1, 2, 4 and 10 weeks after cast removal.
Other outcomes:
Locations:
city: Nuernberg
country: Germany
facility: Novartis
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis
name: Novartis Basel 41 61 324 1111
role: STUDY_CHAIR
References:
Clinical trial NCT05044689: Case Control Study to Identify Modifiable Risk Factors for Colorectal and Breast Cancer in Nigeria
Official title: Case Control Study to Identify Modifiable Risk Factors for Colorectal and Breast Cancer in Nigeria
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Breast Cancer
Lead sponsor: Obafemi Awolowo University Teaching Hospital
Sponsor class: OTHER
Collaborators: name: Memorial Sloan Kettering Cancer Center
name: Lagos State University
name: University of Ilorin Teaching Hospital
name: Federal Medical Centre, Owo
name: University of Maiduguri Teaching Hospital
name: National Hospital, Abuja
First posted: 2021-09-16
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Based on the existing African Research Group for Oncology platform where a current colorectal study is going on, 400 patients with a prior diagnosis and a new diagnosis of colorectal cancer or breast cancer will be recruited into this study.

A combined total of 400 controls will be recruited from community mobilization groups and the Outpatient Health Center at OAU who are free of cancer and gastrointestinal diseases.

Brief summary: This project is a case-control study which seeks to identify modifiable risk factors for breast and colorectal cancer in Nigeria. Both cases and controls will be required to complete a risk factor questionnaire which contains information about their diet, physical activity, past medical history and life style factors. They will also be required to provide information on their body composition through the use of a bioimpedance machine which measures the body mass index, fat and total body water percentage.

Based on the existing ARGO platform where a current colorectal cancer study is going on, approximately 400 patients with a prior diagnosis or a new diagnosis will be recruited into this study. Comparatively, we will select our 400 controls from two groups of participants who are free of cancer and gastrointestinal diseases.


Eligibility criteria: Case Group - Patients must have histologically confirmed diagnosis of colorectal or breast cancer.

Control Group - Patients must not have a diagnosis of cancer.

Primary outcomes:
measure: Development and Validation of Questionnaire For Assessing Modifiable Risk Factors for Cancer in Sub-Saharan Africa
timeFrame: 2 years
measure: Determination of Novel Modifiable Cancer Risk Factors in a Nigerian Population
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ile Ife
country: Nigeria
facility: Obafemi Awolowo University Teaching Hospitals
state: Osun
Study officials:
References:
Clinical trial NCT00420589: A Weight Maintenance Study in Obese Patients (0364-012)(TERMINATED)
Official title: A Study to Assess the Efficacy and Tolerability of Taranabant in Maintaining Weight Loss Induced by Diet in Obese Patients Followed by a 1-Year Extension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Obesity
Keywords: Weight loss
Weight regain
Weight maintenance
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 1000
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: To compare the effects of taranabant versus placebo on weight regain and weight maintenance after low calorie diet-induced weight loss in obese patients.


Eligibility criteria: Inclusion Criteria:

* Patient has a body mass index (BMI) between 30 kg/m² and 43kg/m² and has maintained a stable weight (+/- 3kg) for at least 3 months prior to study start
* Patient is male or female \>=18 and \<= 65 years of age
* Patient understands the study procedures and alternative treatments available
* Patient is able to read, understand and complete study questionnaires

Exclusion Criteria:

* Patient has a history or presence of a major psychiatric disorder
* Patient has a recent history (within 6 months prior to signing the informed consent) diagnosis/episode/recurrence of stroke, TIA or neurological disorder
* Patient has a history of seizures or is at high risk of developing seizures
* Patient has systolic blood pressure \>160mm Hg or diastolic blood pressure \> 100 mm Hg
* Patient has diabetes mellitus as defined by medical history

Primary outcomes:
measure: Body weight at 52 weeks, safety and tolerability.
timeFrame: 52 weeks
Secondary outcomes:
measure: Body weight, biochemical markers, blood pressure, waist circumference and patient reported outcomes at 52 weeks.
timeFrame: 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Wadden TA, Fujioka K, Toubro S, Gantz I, Erondu NE, Chen M, Suryawanshi S, Carofano W, Johnson-Levonas AO, Shapiro DR, Kaufman KD, Heymsfield SB, Amatruda JM. A randomized trial of lifestyle modification and taranabant for maintaining weight loss achieved with a low-calorie diet. Obesity (Silver Spring). 2010 Dec;18(12):2301-10. doi: 10.1038/oby.2010.67. Epub 2010 Apr 8.
Clinical trial NCT02815189: Incidence of Flare-ups and Apical Healing After Single-visit or Two-visits Treatment.
Official title: Incidence of Flare-ups and Apical Healing After Single-visit or Two-visits Treatment of Teeth With Necrotic Pulp and Apical Periodontitis After a Two-year Control Period. A Randomised Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: pain
Lead sponsor: Universidad Autonoma de Baja California
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim to compare Incidence of flare-ups and apical healing after single-visit or two-visits treatment of teeth with necrotic pulp and apical periodontitis after a two-year control period.

110 teeth with a diagnosis of pulp necrosis and apical radiolucency at the apex. Working length was established with EAL and confirmed radiographically. M4 system with Flex-R files were used to complete canal preparation. Level of discomfort were recorded and cases with severe postoperative pain and/or swelling were classified as flare-ups.

Detailed description: 110 teeth with a diagnosis of pulp necrosis and apical radiolucency at the apex. Working length was established with EAL and confirmed radiographically. M4 system with Flex-R files were used to complete canal preparation. Level of discomfort were recorded and cases with severe postoperative pain and/or swelling were classified as flare-ups.

Eligibility criteria: Inclusion Criteria:

* a) Radiographic evidence of apical periodontitis (minimum size ≥2.0 mm x 2.0 mm) and a diagnosis of pulpal necrosis confirmed by negative response to hot and cold tests and b) Need for retreatment. Thermal pulp testing was performed by the author, and radiographic interpretation was verified by one certified oral surgeon.

Exclusion Criteria:

* patients without inclusion requirements or failure to obtain patient´s authorization. Patients, were excluded if they were younger than 18 years old, pregnant, had a positive history of antibiotic use within the past month, suffered from diabetes, or other systemic diseases. Teeth with periodontal pockets deeper than 4 mm also were excluded of the study.

Primary outcomes:
measure: Pain intensity measure with general pain scale
timeFrame: a week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mexico: Secretaria de Salud
name: Miguel O Millan, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00563589: Mycophenolate Mofetil for the Prophylaxis of Graft-versus-host Disease in High Risk Allogeneic Stem Cell Transplantation
Official title: A Randomized Single-center Trial of Mycophenolate Mofetil for the Prophylaxis of Graft-versus-host Disease in High Risk Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Graft vs Host Disease
Hematopoietic Stem Cell Transplantation
Keywords: Acute graft-versus-host disease post high risk allogeneic stem cell transplantation
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
Collaborators: name: Hoffmann-La Roche
First posted: 2007-11-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: There is a significant (50-80%) risk of acute graft-versus-host disease(GVHD) and early mortality (30%) associated with high risk stem cell transplantation (SCT) such as that from a matched unrelated donor or HLA-mismatch sibling. Mycophenolate mofetil (MMF) has been shown to be an effective and safe immunosuppressant in the prevention and treatment of rejection after solid organ transplantation. Its role in acute GVHD prophylaxis in high risk SCT will be investigated in this clinical trial.


Eligibility criteria: Inclusion Criteria:

* patients undergoing allogeneic SCT with high risk of acute GVHD, ie. from matched unrelated donor or one HLA-locus mismatch sibling

Exclusion Criteria:

* known allergy to mycophenolate mofetil

Primary outcomes:
measure: acute GVHD incidence and grading
timeFrame: 100 Days
measure: chronic GVHD incidence
timeFrame: 3 Years
Secondary outcomes:
measure: Mortality, GVHD-related and all cause
timeFrame: 3 Years
measure: Symptomatic side effects attributed to MMF
timeFrame: 60 Days
measure: Date of engraftment
timeFrame: Date of engraftment
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
Study officials:
affiliation: Department of Medicine/ Haematology and Oncology, Queen Mary Hospital
name: Lawrence SY Ma, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05903989: Real-World Treatment Patterns and Patient Reported Outcome in COPD (REMIND)
Official title: A Secondary Database Study Using COPD Cohort Study in Japan to Investigate Health Status of COPD Patients With Different Inhaler Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 708
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Out of 708 COPD patients registered in the COPD cohort study conducted in Japan, total of 448 patients received the following inhaler treatment at cohort entry will be included in this study; LAMA, LAMA+LABA or ICS+LABA .

The patients not treated with the above-listed inhalers or with no COPD treatment at cohort entry will not be included for this study.

Brief summary: This retrospective observational study aims to report distribution of the proportion of symptomatic Chronic obstructive pulmonary disease (COPD) patients classified by the COPD Assessment Test (CAT) managed with single or dual inhaler treatment using the data at cohort entry in the COPD cohort study, and treatment change and longitudinal CAT score by each inhaler treatment will also be evaluated using the data during the follow-up period.


Eligibility criteria: Inclusion Criteria:

* Patients taken with any of following inhaler treatments; LAMA, LAMA+LABA(both single and dual inhaler) or ICS+LABA(both single and dual inhaler) at cohort entry

Exclusion Criteria:

* Patients enrolled at the sites participated in the COPD cohort study where not agreed on secondary use of data for this study

Primary outcomes:
measure: Proportion of patients with CAT (≥10, <10) at registration in each inhaler treatment group (Long acting muscarinic antagonist(LAMA), LAMA+Long acting β2 agonist(LABA) or Inhaled corticosteroid(ICS) +LABA)
timeFrame: At registration
Secondary outcomes:
measure: Proportion of patients with changes of inhaler treatment categories (step up or all other categories) during 1 year follow-up period by patients with CAT (≥10, <10) in each inhaler treatment group (LAMA, LAMA+LABA or ICS+LABA) at registration
timeFrame: 1 year follow-up
measure: Proportion of patients with all patterns of inhaler treatment category changes during 1 year follow-up period by patients with CAT (≥10, <10) in each inhaler treatment group (LAMA, LAMA+LABA or ICS+LABA) at registration
timeFrame: 1 year follow-up
measure: Proportion of patients with CAT (≥10, <10) after 1 year follow-up by patients with CAT (≥10, <10) in each inhaler treatment group (LAMA, LAMA+LABA or ICS+LABA) at registration
timeFrame: 1 year follow-up
measure: Mean change in the CAT scores between at registration and 1 year follow-up in each inhaler treatment group (LAMA, LAMA+LABA or ICS+LABA) at registration
timeFrame: 1 year follow-up
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Research Site
Study officials:
References:
Clinical trial NCT05611489: Laparoscopic Versus Open Appendectomy Prospective Randomized Control Study
Official title: Laparoscopic Versus Open Appendectomy Prospective Randomized Control Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Appendicitis Acute
Keywords: Laparoscopic appendectomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 70
Sex: ALL
Minimum age (years): 5
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: laparoscopic versus open appendectomy
Primary purpose: TREATMENT

Brief summary: laparoscopic versus open appendectomy prospective randomized control study.Both surgical methods are safe and well established in clinical practice but there has been a controversy about which surgical procedure is the most appropriate in this research we are going to demonstrate which operative procedure is more beneficial with less disadvantages.

Detailed description: A double-blind study is one in which neither the participants nor the experimenters know who is receiving a particular treatment. This procedure is utilized to prevent bias in research results. Using envelopes as an allocation concealment method. Each patient will receive two envelopes one contain paper which determine that patient will have open surgery and the other determine that patient will have lap surgery and neither patient nor experimenters know about them and patient shall choose one of them which will determine what surgery will patient undergo .

Eligibility criteria: Inclusion Criteria:

1. patient age between 5-50 year old
2. patient diagnosed as acute appendicitis

Exclusion Criteria:

1. pregnacy
2. perforated appendix
3. severe obese patient
4. previous abdominal exploration

Primary outcomes:
measure: Operative time
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05945680: Tranexamic Acid in Breast Esthetic Surgery.
Official title: The Effectiveness of Tranexamic Acid in Breast Esthetic Surgery.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hemorrhage
Bleeding
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators prepared a novel tranexamic acid (TXA) study designed to estimate the quantity of blood loss in patients undergoing breast esthetic surgery. This study aims to quantify blood loss during abdominoplasty with and without TXA. The central hypothesis is that TXA administration reduces blood loss and fibrinolysis in breast esthetic surgery patients.

Detailed description: Tranexamic acid (TXA) treatment is increasingly emphasized in plastic surgery because TXA inhibits fibrinolysis. Increased clot stability offers the possibility of preventing blood loss (prevention) and mitigating ongoing hemorrhage. TXA therapy has been principally studied in populations; the results of studies in plastic surgery still need to be improved.

Tranexamic acid is an antifibrinolytic agent that acts as a competitive inhibitor at the lysine binding sites of plasminogen and inhibits the ability of protease plasmin to cleave the fibrin clot. In large randomized controlled trials, it has been reported to be effective in decreasing perioperative blood loss in various circumstances, primarily involving trauma patients.

The investigators designed a randomized placebo-controlled trial comparing TXA dosing before incision for breast esthetic surgery. The purpose is to quantify blood loss during plastic surgery with and without TXA.

Eligibility criteria: Inclusion Criteria:

* women scheduled for breast esthetic surgery
* ASA 1 or 2
* age \>18 and \<75 years

Exclusion Criteria:

* BMI \<20 or \>35 kg/m2
* ASA 3 or \> 3
* medical history of thromboembolism
* history of hematological disease
* treatment with aspirin 14 days before the procedure
* treatment with anticoagulants 5 days before the procedure
* epilepsy
* allergy to tranexamic acid
* coagulation disorders

Primary outcomes:
measure: Blood loss volume
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: HBG
timeFrame: 24 hours after surgery
measure: D-dimer
timeFrame: 24 hours after surgery
measure: Fibrinogen
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Poznan University of Medical Sciences
Study officials:
affiliation: Poznań University of Medical Sciences
name: Małgorzata Domagalska, Ph.D.
role: STUDY_CHAIR
References: