louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02146677: Effect of Osteopathic Manipulative Treatment on Pain in Preterms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prematurity
Keywords: prematurity
newborns
pain
cost
Lead sponsor: European Institute for Evidence Based Osteopathic Medicine
Sponsor class: OTHER
First posted: 2014-05-26
Enrollment: 120
Sex: ALL
Minimum age (years): 26
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteopathic manipulative treatment (OMT) has been used to treat term and preterm newborns. Recent studies demonstrated the effectiveness of OMT in reducing length of stay and costs (Cerritelli, 2013) as well as the likelihood of gastrointestinal episodes (Pizzolorusso 2011). Moreover it was reported the absence of adverse events and side effects considering the approach safe (Cerritelli 2013, 2014).

OMT was extensively used to treat, prevent and manage pain symptoms. Numerous research was published addressing acute and chronic pain in different medical conditions. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of OMT in reducing pain in a sample of preterm infants.


Eligibility criteria: Inclusion Criteria:

* preterm infants
* written informed consent by parents or legal guardians
* preterms born in the same hospital

Exclusion Criteria:

* Gestational age \> 37 weeks
* genetic disorders
* congenital disorders
* cardiovascular abnormalities
* proven or suspected necrotized enterocolitis with or without gastrointestinal perforation
* proven or suspected abdominal obstruction
* pre/post surgery patients
* pneumoperitoneum
* atelectasis
* Newborn from an HIV seropositive/drug addicted mother
* respiratory disorders
* transferred to/from other hospital
* admitted for preterminal comfort care (defined as neither intubation nor cardio-respiratory resuscitation)

Primary outcomes:
measure: changes from baseline in pain using Premature Infant Pain Profile (PIPP)
timeFrame: baseline and end of hospitalization, average length of hospitalization expected 4 weeks
Secondary outcomes:
measure: Number of days of length of stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Other outcomes:
measure: Neonatal intensive care unit cost
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Locations:
city: Pescara
country: Italy
facility: Pescara Civil Hospital
state: PE
Study officials:
References:
citation: Cerritelli F, Cicchitti L, Martelli M, Barlafante G, Renzetti C, Pizzolorusso G, Lupacchini M, D'Orazio M, Marinelli B, Cozzolino V, Fusilli P, D'Incecco C. Osteopathic manipulative treatment and pain in preterms: study protocol for a randomised controlled trial. Trials. 2015 Mar 8;16:84. doi: 10.1186/s13063-015-0615-3.
Clinical trial NCT05023577: Antibiotic Combination for H. Pylori Eradication in Penicillin-allergic Patients
Official title: Clarithromycin-, Metronidazole-, or Levofloxacin-containing Therapy for Helicobacter Pylori-infected Penicillin-allergic Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled clinical trial will compare the eradication efficacy of bismuth quadruple therapy containing clarithromycin+metronidazole, clarithromycin+levofloxacin, or metronidazole+levofloxacin for Helicobacter pylori first-line treatment in penicillin-allergic patients. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.


Eligibility criteria: Inclusion Criteria:

* Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
* 18-75 years old on the day of signing the ICF.
* Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.
* Have not received Helicobacter pylori eradication treatment before.
* allergic to penicillin.

Exclusion Criteria:

* Have received Hp eradication treatment.
* Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
* Subjects or guardians refused to participate in the trial.
* Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
* Have taken antibiotics, bismuth, proton pump inhibitors or Chinese traditional medicine 4 weeks before treatment.
* Pregnant or lactating women.
* Active peptic ulcer.
* allergic to drugs used in the trial.
* any other circumstances that are not suitable for recruitment.

Primary outcomes:
measure: Eradication rate of Helicobacter pylori
timeFrame: At least 4 weeks after completion of therapy
Secondary outcomes:
measure: Eradication rate of Helicobacter pylori resistant strains
timeFrame: At least 4 weeks after completion of therapy
measure: Eradication rate of Helicobacter pylori susceptible strains
timeFrame: At least 4 weeks after completion of therapy
Other outcomes:
measure: Adherence rate
timeFrame: 2 weeks during therapy
measure: Frequency of adverse events
timeFrame: 2 weeks during therapy
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Taotao Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00013377: Predictors of Driving Performance and Successful Mobility - Rehabilitation in Patients With Medical Eye Condition
Official title: Predictors of Driving Performance and Successful Mobility - Rehabilitation in Patients With Medical Eye Condition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low Vision
Keywords: Low vision, Driving rehabilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-03-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: There are two diseases in particular that may have serious consequences for driving and mobility due to their potentially severe impact on visual function: glaucoma and diabetic neuropathy. In this project we will develop predictive models of driving for these patients and will train them to use low-vision aids to improve driving mobility. We will determine how best to train patients with hemianopic field loss due to cerebral vascular accidents and identify predictors of long-term success in the use of low-vision aids.

Detailed description: There are two diseases in particular that may have serious consequences for driving and mobility due to their potentially severe impact on visual function: glaucoma and diabetic neuropathy. Both these diseases can potentially result in significant peripheral visual field loss, sometimes coupled with decreased visual acuity. We have previously demonstrated that each of these visual losses alone can have significant impact on driving and mobility performance. In this project we will develop predictive models of driving for these patients and apply our extensive expertise in training patients to use low-vision aids to improve driving mobility. A second question that will be addressed is how to best train scanning patients with hemianopic field loss due to cerebral vascular accidents. We propose to configure the prisms in a bioptic form similar to previously used for amorphic lenses in RP and for bioptic telescopes for patients in macular disease. The third problem that will be addressed is the identification of predictors of long-term success in the use of low-vision aids.

Eligibility criteria: Eye impairment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: VAMC (West Side)
state: Illinois
Study officials:
affiliation: Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
name: John Fryer, Ph. D., Asst. Director
affiliation: Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
name: Nancy Rocheleau, Program Analyst
References:
Clinical trial NCT06335277: Total Body Irradiation Treatments for Patients Treated at European Institute of Oncology
Official title: Total Body Irradiation Treatments for Patients Treated at European Institute of Oncology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Leukemia
Leukemia, Chronic
Leukemia, Acute
Lymphoma
Aplastic Anemia
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated at European Institute of Oncology with Total Body Irradiation (TBI)

Brief summary: Patients eligible undergoing total body irradiation as candidates for bone marrow or peripheral stem cell transplant.

Detailed description: Total Body Irradiation (TBI) is an oncological radiotherapy technique that has been used for several decades in patients undergoing bone marrow or peripheral stem cell transplantation.

The role of TBI is:

To suppress the recipient's immune system to prevent rejection of the donor's bone marrow, whether familial or non-familial.

To eradicate residual neoplastic cells following chemotherapy treatments.

TBI is typically employed in both neoplastic and non-neoplastic disorders affecting blood cell elements (e.g., acute and chronic leukemias, aplastic anemia, lymphomas, etc.), as well as other conditions such as neuroblastoma, Ewing's tumor, and pediatric sarcomas with a poor prognosis.

Treatment choice is usually established following multidisciplinary discussions, based on disease characteristics and stage, concurrent pathologies and pharmacological treatments, patient preferences, and functional aspects. Data collection related to radiotherapy plays a crucial role in understanding various clinical aspects of the treatment itself. The availability of data from an increasing number of patients will allow the identification of clinical situations or technical parameters of radiotherapy correlated with treatment tolerance and effectiveness, aiming to identify the best treatment for these oncological pathologies.

This project aims to collect data related to total body irradiation treatments for scientific dissemination with the goal of establishing the basis for evaluating achieved results over time and deriving from these elements useful for guiding the most effective treatment strategies and appropriate operational protocols.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing total body irradiation as candidates for bone marrow or peripheral stem cell transplantation.
2. Signed informed consent

Exclusion Criteria:

* Patients who do not undergo total body irradiation

Primary outcomes:
measure: Overall Survival
timeFrame: 5 years
measure: Disease free survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Barbara Alicja Jereczek
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01483677: Comparison Study of the Nintendo Wii Versus Playstation2 in Enhancing Laparoscopic Skills
Official title: Is Nintendo Wii a More Suitable Video Game Platform Than Playstation 2 for Enhancing Laparoscopic Skills?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Laparoscopy Skills
Keywords: Laparoscopy
video games
Nintendo Wii
Playstation
Lead sponsor: Beth Israel Medical Center
Sponsor class: OTHER
First posted: 2011-12-01
Enrollment: 42
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators believe that subjects who practice on the Nintendo Wii will improve their laparoscopic skills more than those who practice on the Playstation2.

Detailed description: Video game experience, whether past or current, have correlated with better laparoscopy skills. Those studies were conducted using traditional game controllers. The relatively new Nintendo Wii uses a novel set of mechanics which allows for more realistic representation of player generated movements. We aim to study if the unique mechanics of the Wii can improve laparoscopy skills better than a traditional video game (Playstation 2).

Eligibility criteria: Inclusion Criteria:

* Medical Student, Resident or Attending physician at the Beth Israel Medical center.

Exclusion Criteria:

* None

Primary outcomes:
measure: Difference in the change in box trainer scores between the Wii and Playstation2 groups.
timeFrame: 60 minutes
Secondary outcomes:
measure: Change between pretest and post test scores in the Wii group.
timeFrame: 60 minutes.
measure: Change between pretest and posttest scores for the Playstation2 group
timeFrame: 60 minutes
Other outcomes:
Locations:
city: New York
country: United States
facility: Beth Israel Medical Center of The Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Beth Israel Medical Center
name: Rujin Ju, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Karen C Wang, M.D.
role: STUDY_CHAIR
References:
citation: Derossis AM, Bothwell J, Sigman HH, Fried GM. The effect of practice on performance in a laparoscopic simulator. Surg Endosc. 1998 Sep;12(9):1117-20. doi: 10.1007/s004649900796.
citation: Rosser JC Jr, Lynch PJ, Cuddihy L, Gentile DA, Klonsky J, Merrell R. The impact of video games on training surgeons in the 21st century. Arch Surg. 2007 Feb;142(2):181-6; discusssion 186. doi: 10.1001/archsurg.142.2.181.
citation: Smith CD, Farrell TM, McNatt SS, Metreveli RE. Assessing laparoscopic manipulative skills. Am J Surg. 2001 Jun;181(6):547-50. doi: 10.1016/s0002-9610(01)00639-0.
citation: Lewis TM, Aggarwal R, Rajaretnam N, Grantcharov TP, Darzi A. Training in surgical oncology - the role of VR simulation. Surg Oncol. 2011 Sep;20(3):134-9. doi: 10.1016/j.suronc.2011.04.005. Epub 2011 May 24.
citation: Munz Y, Kumar BD, Moorthy K, Bann S, Darzi A. Laparoscopic virtual reality and box trainers: is one superior to the other? Surg Endosc. 2004 Mar;18(3):485-94. doi: 10.1007/s00464-003-9043-7. Epub 2004 Feb 2.
Clinical trial NCT03454477: Comparison Between Robotic, Endoscopic and Traditional Open Surgery in Thyroidectomy
Official title: From the Endoscope to the Robot, the Initial Experience of Robotic Thyroidectomy is Summarized
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endoscopy
Robotics
Thyroidectomy
Papillary Thyroid Carcinoma
Keywords: Endoscopy
Robotics
Thyroidectomy
Papillary Thyroid Carcinoma
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of endoscopic thyroidectomy, robotic thyroidectomy and conventional open surgery, the safety of the operation, the timing of the operation and the complications.

Detailed description: With the further development of endoscopic technique, thyroid surgery of the robot has emerged, which may become a trend of endoscopic technology due to its convenience and accuracy.In this study, the advantages and disadvantages of endoscopic thyroidectomy and robotic thyroid surgery were compared, and the experience in the transition stage of thyroid surgery in robotic and endoscopic thyroidectomy was summarized.

Eligibility criteria: Inclusion Criteria:

* Thyroid papillary carcinoma.
* The tumor diameter is less than or equal to 1cm.
* The lymph nodes are limited to the VI level.
* Voluntary choice of endoscopy or robotic surgery.

Exclusion Criteria:

* Patients without beauty needs.
* There is lateral neck or mediastinal lymph node metastasis.
* The tumor invades the nerve and surrounding organs.

Primary outcomes:
measure: operation time
timeFrame: The first day after surgery
measure: recurrent laryngeal nerve palsy
timeFrame: 2 months post operation
Secondary outcomes:
measure: thyroid volume
timeFrame: The day before the operation
measure: cosmetic effect
timeFrame: 2 months post operation
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Wen-xin ZHAO
state: Fujian
Study officials:
References:
Clinical trial NCT00828477: Evaluation of Comfort With Xibrom (Bromfenac Ophthalmic Solution)0.09% and Nevanac (Nepafenac Ophthalmic Suspension) 0.1% Following Selective Laser Trabeculoplasty (SLT)
Official title: Evaluation of Comfort With the Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Xibrom (Bromfenac Ophthalmic Solution) 0.09% and Nevanac (Nepafenac Ophthalmic Suspension) 0.1% Following Selective Laser Trabeculoplasty (SLT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intraocular Pressure
Lead sponsor: Bp Consulting, Inc
Sponsor class: NETWORK
First posted: 2009-01-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate and compare the comfort of bromfenac or nepafenac following SLT.

Detailed description: Open label, single armed, cross over controlled study to evaluate comfort and IOP (Intraocular Pressure) changes of specific NSAIDs post SLT. Patients (n= 25, total 50 eyes) scheduled to undergo bilateral Selective Laser Trabeculoplasty (SLT) will instill bromfenac in the first eye to undergo SLT, and the contra lateral eye will receive nepafenac.

Eligibility criteria: Inclusion Criteria:

* \> 18 years old, either gender or any race.
* Diagnosis of open-angle glaucoma or ocular hypertension requiring laser trabeculoplasty.
* Completion of written and informed consent/authorization prior to any study related procedures.
* Able to follow study protocol and likely to complete study schedule.

Exclusion Criteria:

* Known sensitivity to NSAIDs.
* History of neovascular or ocular inflammatory disease.
* Current use of topical or systemic anti-inflammatory medications.
* Females of childbearing potential.

Primary outcomes:
measure: Tolerability of study medication
timeFrame: 28 days
Secondary outcomes:
measure: Intraocular pressure changes
timeFrame: 28 days
measure: Visual Acuity
timeFrame: 28 days
Other outcomes:
Locations:
city: 3340 6 mile Rd Livonia
country: United States
facility: Coburn-Kleinfeldt Eye Clinic
state: Michigan
Study officials:
affiliation: Coburn-Kleinfeldt Eye Clinic
name: Nate Kleinfeldt, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00941577: Study Evaluating the Effects of AIR645 on Allergen-Induced Airway Responses in Subjects With Mild Atopic Asthma
Official title: A Phase 2a, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Bronchial Allergen Challenge Study to Assess the Safety, Tolerability, and Efficacy of Inhaled AIR645 in Subjects With Mild Allergic Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity
Lead sponsor: Altair Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2009-07-17
Enrollment: 30
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: TREATMENT

Brief summary: To assess the efficacy of inhaled AIR645 in the suppression of the Asthmatic Responses in subjects with mild asthma inhaling an allergen.


Eligibility criteria: Inclusion Criteria:

* Men and women with well controlled mild allergic asthma, aged 18 to 65 years
* Only asthma med is short-acting bronchodilator used not more than twice weekly
* FEV1 greater than 70% predicted and a demonstrated baseline late response to allergen induction

Primary outcomes:
measure: Area under the curve (AUC) of the percentage decrease forced expiratory volume in one second (FEV1) from baseline between AIR645 and placebo
timeFrame: 36 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
state: Ontario
city: Laval
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
Study officials:
affiliation: Altair Therapeutics, Inc.
name: Mike Hodges, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00216177: Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis
Official title: Randomised, Multicenter, Open-label, Parallel-group Study Comparing Adalimumab 40 mg s.c. Eow Versus Infliximab 3 mg/kg i.v. Every 6 Weeks in Rheumatoid Arthritis Patients With Unsustainable Clinical Response to Infliximab 3 mg/kg Every 8 Weeks
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Gentofte, Copenhagen
First posted: 2005-09-22
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 establish whether RA patients with moderate to severe disease activity with unsustainable response to infliximab 3 mg/kg every 8 weeks have better efficacy with adalimumab 40 mg s.c. eow compared to infliximab 3 mg/kg i.v. every 6 weeks.


Eligibility criteria: Inclusion Criteria:

* ACR criteria fulfilled,DAS28-3(CRP \> 3.2
* \> 6 months prior treatment with infliximab 3 mg/kg i.v. every 8 week with initial response
* Fading clinical response to infliximab
* Negative pregnancy test (women with childbearing potential)
* Use of reliable method of contraception (women with childbearing potential)
* Informed consent

Exclusion Criteria:

* Age less than 18 years
* Lack of co-operability
* Positive serology for hepatitis B or C
* History of positive HIV status
* History of TB or untreated latent TB
* Histoplasmosis or Listeriosis
* Pregnancy or breastfeeding
* Persistent or recurrent infections
* History of cancer
* Uncontrolled diabetes
* Ischaemic heart disease
* Congestive heart failure (NYHA 3-4)
* Active inflammatory bowel disease
* Recent stroke (within 3 months)
* History of or current inflammatory joint disease other than RA
* Previous diagnosis or signs of central nervous system demyelinating disease

Primary outcomes:
measure: Proportion of patients achieving combined good or moderate EULAR responses at week 24
timeFrame: six months
Secondary outcomes:
measure: ACR20/50/70 response at week 2, 6, 12, 18 and 24
timeFrame: six months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre Hospital
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Copenhagen
country: Denmark
facility: Gentofte Amtssygehus
city: Copenhagen
country: Denmark
facility: Glostrup Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Graasten
country: Denmark
facility: Graasten Gigthospital
Study officials:
affiliation: Hvidovre University Hospital
name: Henrik Skjodt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: