louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01935986: The Effect of a Probiotic on Protection Against Upper Respiratory Tract Infections in Children
Official title: The Effect of a Probiotic on Protection Against Upper Respiratory Tract Infections in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Upper Respiratory Tract Infection
Lead sponsor: Probi AB
Sponsor class: INDUSTRY
First posted: 2013-09-05
Enrollment: 131
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to study the effect of a probiotic on protection against upper respiratory tract infections (URTI) in children.


Eligibility criteria: Inclusion Criteria:

* healthy children

Exclusion Criteria:

-

Primary outcomes:
measure: upper respiratory tract infections
timeFrame: study period, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Foodfiles Sweden Ab
Study officials:
References:
Clinical trial NCT03297086: Changes of Angle Kappa After Implantation of Multifocal Intraocular Lenses
Official title: Changes of Angle Kappa After Implantation of Multifocal Intraocular Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Presbyopia
Keywords: multifocal intraocular lens, angle kappa, presbyopia
Lead sponsor: Semmelweis University
Sponsor class: OTHER
Collaborators: name: Medicontur Kft
First posted: 2017-09-29
Enrollment: 30
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 possible changes of angle kappa after multifocal intraocular lens implantation. Presumable influencing factors of postoperative visual axis shift (ie. biometric parameters of the eye) are investigated to determine the degree and direction of angle kappa alterations.

Detailed description: The purpose of this study is to evaluate changes of angle kappa after multifocal intraocular lens implantation.

During cataract surgery Medicontur Bi-Flex 677MY IOL and Alcon Acrysof Restor SN6AD1 IOL are implanted. Optical biometry is carried out for IOL calculation and to measure axial length and angle kappa. Three months after surgery biometry is repeated, IOL position and angle kappa are measured using Scheimpflug-camera.

Eligibility criteria: Inclusion Criteria:

* Patients with age related cataract and presbyopia

Exclusion Criteria:

* Patients with previous ocular surgery, trauma, active ocular disease, poorly dilated pupils, or known zonular weakness and corneal astigmatism \>1.5 diopters were excluded from the study.

Primary outcomes:
measure: Measurement of changes of angle kappa after multifocal intraocular lens implantation.
timeFrame: 3 months
Secondary outcomes:
measure: Determination of influencing effect of biometrical data on postoperative visual axis shift
timeFrame: 3 months
measure: Determination of influencing effect of intraocular lens decentration on postoperative visual axis shift
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00758186: Randomized Trial of Colonic Stents as a Bridge to Surgery
Official title: Endoscopic Stenting and Elective Surgery Versus Emergency Surgery for Left-sided Malignant Colonic Obstruction: A Prospective Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Intestinal Obstruction
Keywords: Colorectal cancer
Endoscopic stent
Intestinal obstruction
Laparoscopy
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2008-09-25
Enrollment: 40
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 objective of this randomized controlled trial was to evaluate the role colonic self-expanding metal stent (SEMS) placement as a bridge to surgery in patients with acute malignant left-sided colonic obstruction. The study was designed to test the hypothesis that SEMS placement could be effectively and safely used in this group of patients to relieve colonic obstruction thereby allowing safe recovery and medical stabilization before proceeding to elective surgery


Eligibility criteria: Inclusion Criteria:

* Acute intestinal obstruction secondary to left-sided colonic cancer

Exclusion Criteria:

* Distal rectal cancers
* Patients with signs of peritonitis suggestive of bowel perforation

Primary outcomes:
measure: The primary endpoint was postoperative complication rates.
timeFrame: 30 days
Secondary outcomes:
measure: Secondary outcomes evaluated included type of surgery performed, bowel preservation, presence of a stoma, postoperative bowel function, length of hospital stay, and hospitalization costs.
timeFrame: 3 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Department of Colorectal Surgery, Singapore General Hospital
Study officials:
affiliation: Department of Colorectal Surgery, Singapore General Hospital
name: Kok-Sun Ho, FRCSEd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lim JF, Tang CL, Seow-Choen F, Heah SM. Prospective, randomized trial comparing intraoperative colonic irrigation with manual decompression only for obstructed left-sided colorectal cancer. Dis Colon Rectum. 2005 Feb;48(2):205-9. doi: 10.1007/s10350-004-0803-9.
citation: Saida Y, Sumiyama Y, Nagao J, Uramatsu M. Long-term prognosis of preoperative "bridge to surgery" expandable metallic stent insertion for obstructive colorectal cancer: comparison with emergency operation. Dis Colon Rectum. 2003 Oct;46(10 Suppl):S44-9. doi: 10.1097/01.DCR.0000087483.63718.A2.
citation: Martinez-Santos C, Lobato RF, Fradejas JM, Pinto I, Ortega-Deballon P, Moreno-Azcoita M. Self-expandable stent before elective surgery vs. emergency surgery for the treatment of malignant colorectal obstructions: comparison of primary anastomosis and morbidity rates. Dis Colon Rectum. 2002 Mar;45(3):401-6. doi: 10.1007/s10350-004-6190-4.
citation: Khot UP, Lang AW, Murali K, Parker MC. Systematic review of the efficacy and safety of colorectal stents. Br J Surg. 2002 Sep;89(9):1096-102. doi: 10.1046/j.1365-2168.2002.02148.x.
Clinical trial NCT06886386: TsDCS and Physical Therapy After Incomplete Spinal Cord Injury
Official title: Effects of Trans-spinal Direct Current Stimulation Combined to Physical Therapy in Patients with Chronic Incomplete Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Spinal Cord Injury
Keywords: trans-spinal direct current stimulation
physical therapy
spinal cord injury
motor function
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effects of tsDCS combined with physical therapy on the recovery of motor function in adult patients with chronic incomplete spinal cord injury.

Detailed description: A randomized, sham-controlled, double-blinded and parallel group trial (10 therapeutic sessions). Active or sham tsDCS will be combined with physical therapy to verify the improvement of motor function in patients with incomplete spinal cord injury. Assessments will be performed before and after therapeutic sessions and at the 30-day follow-up after the intervention, through: (i) ASIA Lower and Upper Extremities Motor Scale (LEMS and UEMS), (ii) ASIA Impairment Scale (AIS), (iii) Ashworth Modified Scale; (iv) the Functional Independence Measure (SCIM-III), and (v) the Patient Global Impression of Change Scale - (PGICS).

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of incomplete spinal cord injury by a neurologist
* Diagnosis time greater than 12 months

Exclusion Criteria:

* Patients with additional current neurological diagnoses
* Presence of contraindications for tsDCS

Primary outcomes:
measure: Changes in the Upper and Lower Extremities Motor Scale (UEMS and LEMS) from ASIA.
timeFrame: Before the sessions, after 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.
Secondary outcomes:
measure: Changes on American Spinal Cord Injury Association - Impairment Scale (AIS)
timeFrame: Before the sessions, after 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.
measure: Changes on Spinal cord independence measure (Self-Reported) III (SCIM-III)
timeFrame: Before the sessions, after 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.
measure: Change from Modified Ashworth scale (MAS)
timeFrame: Before the sessions, after 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.
measure: Changes on Patient Global Impression of Change Scale - (PGICS)
timeFrame: After 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Applied Neuroscience Laboratory
state: Pernambuco
Study officials:
References:
Clinical trial NCT01757886: inflAmmatory maRkers in Blood and Thrombus Aspirated From Patients With acutE myocaRdial Infarction With St-segment elevAtion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Admitted With the Diagnosis of ST-elevation Acute Coronary Syndrome
Keywords: Myocardial infarction, Inflammation, Thrombus, Coronary angioplasty.
Lead sponsor: Fundación Canaria Rafael Clavijo para la Investigación Biomédica
Sponsor class: OTHER
First posted: 2012-12-31
Enrollment: 100
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: Pilot, prospective cohort, which included all patients admitted with a diagnosis of ST-elevation myocardial infarction and undergoing thrombus aspiration during a procedure effective emerging percutaneous coronary revascularization.

Brief summary: The prognostic value of inflammatory markers in acute coronary syndrome has been extensively demonstrated, however it is still unknown whether there is an association between circulating and local (thrombus) inflammatory molecules, and the subset of molecules that provide better prognostic information in patients with ST-elevation acute coronary syndrome.


Eligibility criteria: Inclusion Criteria:

* They include patients of both sexes, without limits of age, with a diagnosis of STEMI within 12 hours after the beginning of symptoms. ST-elevation myocardial infarction was defined in the presence of symptoms consistent, persistent elevation (\> 20 min) ST segment ≥ 1 mm in at least two contiguous leads or in the presence of left bundle branch block presumably new onset and cardiac troponin I elevation

Exclusion Criteria:

* Injury significant common core of left coronary artery (stenosis greater than or equal to 50% of the vessel lumen).
* Pre-Fibrinolysis percutaneous coronary intervention.
* Previous coronary bypass surgery.
* Thyrotoxicosis.
* Having an inflammatory systemic or local inflammatory process.
* Malignant neoplasm.
* Any disease that seriously compromise the prognosis and / or systemic inflammatory response generated.
* No thrombotic material obtained in the thrombus or insufficient for performing biochemical determinations.

Primary outcomes:
measure: The primary objective of the study is to find out whether there is an association between certain inflammatory markers in blood and intracoronary thrombus and whether these markers are associated with the composite of all-cause mortality
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz de Tenerife
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz de Tenerife
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Tenerife
Study officials:
affiliation: Hospital Universitario de Canarias
name: Alberto Dominguez-Rodriguez, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05109286: A Controlled Trial to Evaluate the Benefits of CrossFit in People Who Work Predominantly in a Sedentary Manner.
Official title: MedXFit Intervention for Predominantly Seated People
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: People With Predominantly Sedentary Work
Lead sponsor: Bundeswehr University Munich
Sponsor class: OTHER
Collaborators: name: CrossFit Kokoro
First posted: 2021-11-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: People who predominantly sit down often suffer from spinal complaints. This is mainly caused or intensified by a lack of exercise and a shortened posterior muscle chain.

This study aims to investigate whether CrossFit can improve physical deficits, reduce pain, and improve quality of life.

For this purpose, 30 test persons should take part in regular CrossFit training twice a week over one year. In addition, as a control group, 30 persons are also observed who exercise according to their ideas.


Eligibility criteria: Inclusion Criteria:

* Predominantly sedentary work
* Willingness to participate in CrossFit training

Exclusion Criteria:

* Medical reasons against participating in regular exercise
* Acute severe injuries to the musculoskeletal system (e.g. broken bones, torn tendons)

Primary outcomes:
measure: Mobility
timeFrame: 1 year
Secondary outcomes:
measure: Strength Symmetry
timeFrame: 1 year
measure: Strength
timeFrame: 1 year
measure: Subjective Well-Being
timeFrame: 1 year
Other outcomes:
Locations:
city: Neubiberg
country: Germany
facility: Universität der Bundeswehr
state: Bavaria
Study officials:
affiliation: Bundeswehr University Munich
name: Annette Schmidt, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04491786: The Efficacy of Postoperative Analgesia of Gabapentin Plus Nefopam in the Spinal Surgery
Official title: Department of Anaesthesiology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Fusion
Keywords: Gabapentin
Nefopam
Spinal surgery
Postoperative analgesia
Lead sponsor: Gia Dinh People Hospital
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention group will treated postoperative analgesia with 600 mg of gabapentin plus 65 mcg/kg/hour during 24 hours of nefopam
Primary purpose: TREATMENT

Brief summary: The acute pain after spinal surgery is serious. The most pain is during 24 hours after surgery. The multimodal therapy is a method which is applied to treat the postoperative pain.

Morphine is main analgesic to treat postoperative pain. However, some the side-effects can occur to patients and there are associate with dosage. So, some analgesics usually combinate with morphine to postoperative analgesia, include gabapentin, celecoxib, ketamine, ...

Nefopam is a central analgesic. There are effect prevent hyperalgesia. The effect of the combination of gabapentin with nefopam to postoperative analgesia in spinal surgery hasn't been reported yet.

The gabapentin oral with 600 mg combine with continuously intravenous nefopam with 65 µg/kg/hour during 24 hours after spinal surgery whether to increase the effect of postoperative analgesia.

The investigators hypothesized that the gabapentin oral with 600 mg combine with continuously intravenous nefopam with 65 µg/kg/hour during 24 hours after spinal surgery can decrease 40% of the consumption of morphine during 24 hours.

Detailed description: After enrolled, all participants will randomly assigned into the two groups. The intervention group (GAPA-group) will treated preoperative oral 600 mg of gabapentin. After general anesthesia, all participants of both groups will continuously transfused 65 µg/kg/hour of nefopam during 24 hours. After surgery, all cases will treated analgesia with morphine-PCA (2 mg of singe dose, 5 minutes of lockout time, and 6 mg of one hour).

The efficacy of postoperative analgesia will evaluated with the consumption of morphine during 24 hours.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 70.
* Spinal selective surgery

Exclusion Criteria:

* Allergy one of drugs in study.
* Neurological disorder.

Primary outcomes:
measure: Consumption of morphine
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Side-effect
timeFrame: Postoperative 24 hours
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Binh Huynh
state: Ho Chi Minh
Study officials:
affiliation: Nhan dan Gia Dinh Hospital
name: Binh V. Huynh
role: STUDY_CHAIR
References:
Clinical trial NCT06106386: The Effect of Different Intraradicular Cryotherapy on Post-operative Pain and the Level of Substance P
Official title: The Impact of Using Cold Irrigation on Postoperative Endodontic Pain and Substance P Level: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Inflammation
Keywords: Cryotherapy
Substance P
Apical periodontitis
Post Operative Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical trial is to evaluate the effect of using intra-radicular cryotherapy technique in the form of irrigation with cold sodium hypochlorite

The main questions to answer are:

1. Does Postoperative pain is different between the three groups?
2. Does level of substance P different between the three groups ?

Detailed description: * The patients will be randomly divided into three groups Group 1: control group (n=25) Regular root canal treatment with regular irrigant will be used. Group 2: (n=25) Intraradicular cryotherapy will be performed where :
* Normal root canal treatment will be done with irrigation using sodium hypochlorite cooled to 2°C continuously during our mechanical instrumentation. Then a final flush will be done with cold saline 2°C for 5 minutes. Group 3: (n=25) Normal root canal treatment will be done with irrigation using sodium hypochlorite at room temperature during our mechanical instrumentation. Then a final flush will be done with cold saline 2°C for 5 minutes.

Eligibility criteria: Inclusion Criteria:

* Patients that will be diagnosed with symptomatic apical periodontitis
* Single-rooted premolars (radiographically and clinically assessed)
* Medically free patients.
* Teeth with mature apex

Exclusion Criteria:

* Patients with other pulpal diagnosis.
* Medically compromised patients.
* Pregnant females.
* Patients taking analgesics or anti-inflammatory drugs.

Primary outcomes:
measure: Level of post operative pain
timeFrame: after 6 hours, 24 hours, 48 hours, 72 hours
Secondary outcomes:
measure: Level of substance P
timeFrame: After access cavity, after finishing mechanical perpetration, before obturation(after 3 days)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Faculty of dentistry Ain Shams University
name: Maram F Obeid, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01893086: Impact of Opportunistic Salpingectomy on Ovarian Reserve in Patients Undergoing Laparoscopic Hysterectomy
Official title: Impact of Opportunistic Salpingectomy on Ovarian Reserve in Patients Undergoing Laparoscopic Hysterectomy: a Multi-center, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Uterine Disease
Lead sponsor: CHA University
Sponsor class: OTHER
First posted: 2013-07-08
Enrollment: 68
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recently, many gynecologic oncologists proposed that surgeons should consider opportunistic salpingectomy to prevent ovarian cancer for all patients undergoing hysterectomy for benign disease. However, the safety and the consequences regarding ovarian function after salpingectomy have not yet to be established. Therefore, the aim of this randomized controlled study is compare the ovarian reserve via anti-Müllerian hormone (AMH) between laparoscopic hysterectomy (LH) alone and LH combined with salpingectomy.


Eligibility criteria: Inclusion Criteria:

* women who were planning to undergo laparoscopic hysterectomy for benign uterine diseases
* women aged between 19 and 52 years
* women with regular menstruation (defined as the duration of menstrual cycle between 21 and 45 days)
* women who were appropriated medical status for laparoscopic surgery

Exclusion Criteria:

* any ovarian cysts requiring ovarian surgery
* any suspicious findings of malignant diseases
* history of prior salpingectomy or salpingo-oophorectomy
* pregnant or menopausal status
* preoperative serum anti-Müllerian hormone (AMH) \< 0.30 ng/mL
* use of hormonal treatments in the three months before surgery
* any other endocrine disease (such as uncontrolled thyroid dysfunction, hyperprolactinemia, or Cushing syndrome)
* an inability to understand and provide written informed consent.

Primary outcomes:
measure: Change in ovarian reserve
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University School of Medicine
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: CHA Gangnam Medical Center
Study officials:
affiliation: Kangbuk Samsung Hospital, Seoul, Republic of Korea
name: Taejong Song, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: