louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02847156: Impact of Respiratory Viral Infections in Infants With Cystic Fibrosis.
Official title: Clinical and Microbiological Impact of Respiratory Viral Infections in the Short and Medium Term in Infants (<24 Months) With Cystic Fibrosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Respiratory Viral Infection
Keywords: cystic fibrosis
viruses
respiratory viral infection
children
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 25
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Respiratory Viral Infections (RVI) are particularly frequent in young children. Old data mention the deleterious role of some viruses such as the Respiratory Syncytial Virus in young children with cystic fibrosis (CF). However, recent epidemiological data on RVI in CF children are rare and the impact of most frequent viruses such as human rhinoviruses is usually not correctly evaluated.

The aim of this study is to assess the frequency of lower and upper RVI during a 1 year follow-up in CF infants and to evaluate the impact of RVI at a clinical, microbiological and therapeutic level.

Our hypothesis is that frequent and/or clinically severe RVIs have the worst impact in the short term and without any particular link with a specific virus as previously described.


Eligibility criteria: Inclusion Criteria:

- infant \<24 months with cystic fibrosis

Exclusion Criteria:

- patient \>24 months

Primary outcomes:
measure: Number of Respiratory Viral Infection
timeFrame: up to 12 months
Secondary outcomes:
measure: Identification of respiratory viruses in throat-swabs
timeFrame: up to 12 months
measure: Number of antibiotics treatments (oral or IV)
timeFrame: up to 12 months
measure: Number of bronchodilator administrations
timeFrame: up to 12 months
measure: Number of corticosteroids administrations
timeFrame: up to 12 months
measure: Number of hospitalization or hospital admission due to upper or lower RVI
timeFrame: up to 12 months
measure: Identification of bacterial flora in throat-swabs
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Cystic Fibrosis Pediatric Reference Centrer, Hospices Civils de Lyon
Study officials:
affiliation: Cystic Fibrosis Pediatric Reference Centrer, Hospices Civils de Lyon, 69677 Bron Cedex, France
name: Stéphanie VRIELYNCK, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01613456: Effect of Saccharomyces Cerevisiae on the Symptoms of Irritable Bowel Syndrome
Official title: Effect of S.Cerevisiae vs Placebo on the Improvement of Gastrointestinal Disorders,Especially During Irritable Bowel Syndrome. Randomized, Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Lesaffre International
Sponsor class: INDUSTRY
Collaborators: name: BioFortis
name: University of Nottingham
First posted: 2012-06-07
Enrollment: 364
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: SUPPORTIVE_CARE

Brief summary: The main purpose of this study is the effect of the probiotic yeast Saccharomyces cerevisiae CNCM I-3856 on abdominal pain or intestinal discomfort in patients presenting with the irritable bowel syndrome (IBS)


Eligibility criteria: Inclusion criteria:

* IBS subject meeting the Rome III criteria , with a discomfort or pain present more than 1 day per week in whom organic causes of their symptoms have been excluded
* IBS-C with less than 3 complete spontaneous bowel movements/week
* IBS-D with at least 2 or more days/week one stool which has consistency of type 6 or 7 Bristol stool score
* Subject able of and willing to comply with the protocol and to give their written informed consents

Exclusion criteria:

* History of chronic gastrointestinal disorders
* History of lactose intolerance
* History of gluten intolerance
* Treatment able to influence IBS, modifying intestinal sensitivity and motility (antidepressants,opioid, narcotic analgesics)
* Eating disorders
* Pregnancy in progress

Primary outcomes:
measure: Change from baseline in discomfort score,obtained by Daily Likert Scale averaged by week
timeFrame: baseline and week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Herblain
country: France
facility: Biofortis
Study officials:
affiliation: BioFortis
name: David GENDRE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nottingham Digestive Diseases Centre University Hospital
name: Robin SPILLER, Professor of Gastroenterology
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spiller R, Pelerin F, Cayzeele Decherf A, Maudet C, Housez B, Cazaubiel M, Justen P. Randomized double blind placebo-controlled trial of Saccharomyces cerevisiae CNCM I-3856 in irritable bowel syndrome: improvement in abdominal pain and bloating in those with predominant constipation. United European Gastroenterol J. 2016 Jun;4(3):353-62. doi: 10.1177/2050640615602571. Epub 2015 Aug 21.
Clinical trial NCT04808856: Treatment of Refractory Gout With ACTH or Methylprednisolone
Official title: Treatment of Refractory Gout With Adrenocorticotropic Hormone or Methylprednisolone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gout
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 60
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: To clarify the therapeutic effect and safety evaluation of ACTH in refractory gouty arthritis and special population, and to explore its mechanism of action.

Detailed description: When patients with acute gout have multiple comorbidities and complications , traditional treatment methods are often contraindicated . From the current clinical research evidence , we have seen the non-inferior effect of ACTH on glucocorticoids and non-steroidal anti-inflammatory drugs in the treatment of acute gout , as well as the good safety and extensive anti-inflammatory effect in addition to efficacy . Therefore , we designed this study to update and improve the treatment of acute gout attacks , and to try to clarify the mechanism of action .

Eligibility criteria: Inclusion Criteria:

* (123 items and 1 item from 4-7 are met simultaneously) :

  1. Meet the 2015 ACR/EULAR classification diagnostic criteria for gout
  2. Acute gouty arthritis
  3. Age ≥18
  4. Repeated attacks and prolonged pain (more than 1 month);
  5. poor response or intolerance to colchicine or NSAIDs;
  6. Liver and kidney dysfunction;
  7. Old age;

Exclusion Criteria:

* 1) History of gastrointestinal bleeding and active ulcer 2) The application history of glucocorticoids and ACTH in 1 month before screening 3) Pregnancy and lactation 4) Drug and alcohol abuse 5) Malignant tumor (treated or untreated within 5 years) 6) Mental illness inability to communicate or have language barriers and inability to fully understand and cooperate 7) negligent compensatory heart failure, unstable angina pectoris, stroke, transient ischemic attack, myocardial infarction, and severe arrhythmia occurred within 6 months 8) The investigator did not consider it appropriate to participate in the study

Primary outcomes:
measure: Measurement of pain
timeFrame: 7 days
measure: Arthritis score
timeFrame: 7 days
Secondary outcomes:
measure: Recurrence rate
timeFrame: 1 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's hospital
state: Shanghai
Study officials:
affiliation: Shanghai Tenth People' Hospital
name: Shen Qu, M.D Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02357056: Randomized Controlled Evaluation of Robotic Cardiac Surgery Training Modalities
Official title: Randomized Controlled Evaluation of Robotic Cardiac Surgery Training Modalities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Robotic Surgery Simulation Training
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this research is to objectively compare various training modalities currently available in minimally invasive and robotic surgery to determine the most effective training methods specific to robotic cardiac surgery. We hope to recruit medical trainees with minimal robotic surgery training experience, randomly assigned to one of three groups (Dry wab, da Vinci Simulator and Wet lab). Trainees will be evaluated at baseline for a standardized tasks common in robotic cardiac surgery and then divided into one of the three training modalities. Trainees will be given sufficient time to become proficient with a variety of predetermined tasks unique to each training group. The trainees will then undergo a reevaluation with the cardiac surgery specific tasks at the end of a standard training period. We will then be able to compare our three groups to show if any have benefits over the others in regards to improvement in technical ability, understanding of the robots functions, efficacy of training, speed of technical skill development, accuracy and efficiency of movement. We will rate each modality on their reproducibility, accuracy of representation, and ease of set up and perform a cost analysis for each of the training methods.


Eligibility criteria: Inclusion Criteria:

* Residents, fellows and staff of a surgical specialty with less then 10 hours using the daVinci robot or any robotic simulator.

Exclusion Criteria:

* Individuals not associated with a surgical program
* Individuals with \>10 hours experience driving the daVinci Robot or any robotic simulator

Primary outcomes:
measure: Time to Complete Mitral Valve Annuloplasty
timeFrame: 3 months
measure: Time To Complete 10cm dissection of the Internal Thoracic Artery
timeFrame: 3 months
measure: Global Evaluative Assessment of Robotic Skills (GEARS) Score
timeFrame: 3 Months
Secondary outcomes:
measure: Duration of Training
timeFrame: 3 Months
Other outcomes:
Locations:
city: London
country: Canada
facility: Canadian Surgical Technologies & Advanced Robotics (CSTAR)
state: Ontario
Study officials:
affiliation: Department of Cardiac Surgery
name: Bob Kiaii, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valdis M, Chu MW, Schlachta CM, Kiaii B. Validation of a Novel Virtual Reality Training Curriculum for Robotic Cardiac Surgery: A Randomized Trial. Innovations (Phila). 2015 Nov-Dec;10(6):383-8. doi: 10.1097/IMI.0000000000000222.
Clinical trial NCT03731156: Granulomatous Pneumocystis Pneumonia
Official title: Biological Diagnosis of Granulomatous Pneumocystis Pneumonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Nodule
Invasive Fungal Infections
Pneumocystis Jirovecii
Keywords: Granulomatous Pneumocystis Pneumonia
PCR Pneumocystis jirovecii
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with pulmonary nodule

Brief summary: The intra-alveolar form of Pneumocystis jiroveci pneumonia (PjP) is a common pathology in immunocompromised patients, particularly those infected with HIV. The diagnosis is based on the detection of Pj in a LBA. Intra-tissue granulomatous form (PGP) is a rare entity observed in non-HIV immunocompromised patients. In this case, the LBA is mostly non-contributory and the diagnosis is based solely on the detection of cysts on histological examination on biopsy of a pulmonary nodule. For many years, it has been clearly demonstrated that the use of a specific PCR clearly improves the biological diagnosis of PcP. However, in case of granulomatous form this method is not implemented because the diagnostic hypothesis is not mentioned.

In 2018, two cases of PGP were diagnosed at 3-month intervals at Montpellier University Hospital Center. The diagnostic confirmation was obtained with PCR Pj. In this context the investigators will investigate the interest of implementing PCR Pj on biopsies on pulmonary nodules from hospitalized patients between 2015 and 2018. In all selected patients, histopathological aspect of the nodule was compatible with a PGP and, no other diagnosis has been confirmed (infectious, tumoral, inflammatory ...). Finally, 17 patients were selected to check retrospectively, if the presence of Pj could be at the origin of the pathology.


Eligibility criteria: Inclusion Criteria:

* pulmonary nodule

Exclusion Criteria:

* nodule : tumoral, other infections than Pj, inflammatory

Primary outcomes:
measure: PCR results
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Laurence Lachaud, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04026256: Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration
Official title: Mechanisms Underlying the Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postmenopausal Osteoporosis
Keywords: osteoporosis
histomorphometry
bone density
teriparatide
denosumab
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2019-07-19
Enrollment: 37
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to examine, via iliac crest bone biopsies, the mechanism of combined teriparatide and denosumab on the bone of postmenopausal osteoporotic women after 3 months of treatment.


Eligibility criteria: Inclusion Criteria:

* women aged 45+
* postmenopausal
* osteoporotic with high risk of fracture

Exclusion Criteria:

* significant previous use of bone health modifying treatments
* known congenital or acquired bone disease other than osteoporosis
* significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease
* abnormal calcium or parathyroid hormone level
* serum vitamin D \<20 ng/mL or \>60ng/mL
* serum alkaline phosphatase above upper normal limit with no explanation
* anemia (hematocrit \<32%)
* history of malignancy (except non-melanoma skin carcinoma), radiation therapy, or gouty arthritis
* history of urolithiasis within the last one year
* excessive alcohol use or substance abuse
* use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months
* extensive dental work involving extraction or dental implant within the past or upcoming 2 months
* known sensitivity to mammalian cell-derived drug products
* known contraindications to denosumab, teriparatide, or any of their excipients
* known contraindications to tetracycline, demeclocycline, or other antibiotics in this drug class
* continuous use of tetracycline for \>1-month duration within the last 10 years

Primary outcomes:
measure: Cancellous Bone Formation Rate at Month 3
timeFrame: 3 months after first dose of study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Benjamin Leder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01154556: RETRIeVE: ReversE TranscRiptase Inhibitor hiV Practice
Official title: Non-nucleoside Reverse Transcriptase Inhibitor Failure in a High HIV Caseload Australian Primary Care Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Positive
Keywords: Antiretroviral therapy experienced
failed NNRTI regime
Lead sponsor: Holdsworth House Medical Practice
Sponsor class: OTHER
First posted: 2010-07-01
Enrollment: 2044
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Demographic information will be collected from patient medical records for all patients that have used previously, or are currently using an NNRTI as part of HIV treatment therapy.

Brief summary: An observational retrospective study of NNRTI experienced patients who have virologically failed. The study aims to assess resistance profiling and subsequent prescription patterns of patients on NNRTIs

Detailed description: This is a cross-sectional study involving retrospective review of HIV-1 positive patient records who began treatment with a non-nucleoside reverse transcriptase inhibitor (NNRTI) and subsequently failed. Patients who have virologically failed previous NNRTI treatment, or have resistance to 1 drug in the NNRTI class are examined further. Such patients will have attended the clinic every 3-6 months for routine medical care. The data source for variables collected is the patient's electronic medical records. This database is located at Holdsworth House Medical Practice (HHMP), Sydney.

Eligibility criteria: Inclusion Criteria:

1. Documented HIV infection
2. Attended Holdsworth House Medical Practice 1999-2009.
3. Chosen ART regime includes an NNRTI

Exclusion Criteria: N/A

Primary outcomes:
measure: resistance profiling and subsequent prescription patterns of patients on NNRTIs
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
Study officials:
References:
Clinical trial NCT01804556: The Effects of the Myofascial Trigger Point Injections on Pain and Sleep Disturbance in Patients With Nocturnal Leg Cramps With Trigger Points on Gastrocnemius Muscle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nocturnal Leg Cramps
Keywords: muscle cramps, trigger points, sleep disturbance
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-03-05
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Nocturnal leg cramps is involuntary strong contraction of leg muscle, mostly in calves. It occurs suddenly and induces pain. Patients with frequent nocturnal leg cramps suffer from sleep disturbance in company with pain. In the present study, we examined the effects of the myofascial trigger point injections, which are known to be helpful for ease of nocturnal leg cramps, on pain and sleep disturbance in patients with nocturnal leg cramps with trigger points on gastrocnemius muscle.


Eligibility criteria: Inclusion Criteria:

* Adult patients (20-80 years of age) scheduled for myofascial trigger point injections on gastrocnemius muscle due to nocturnal leg cramps at least once a week

Exclusion Criteria:

* Patients with no trigger points on gastrocnemius muscle,
* electrolyte abnormality,
* congenital musculoskeletal disorder,
* local or systemic infection, bleeding disorder or the use of anticoagulation medications,
* known allergy of local anesthetics, or the use of hypnotics or sedatives in the last 1 month

Primary outcomes:
measure: Pain score
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Al-Shaikh B, George William M, Van Zundert AA. Using atmospheric pressure to inflate the cuff of the Portex Laryngeal Mask. Anaesthesia. 2005 Mar;60(3):296-7. doi: 10.1111/j.1365-2044.2005.04135.x. No abstract available.
Clinical trial NCT00470756: Forefoot Adduction (FFA) in Infants and Toddlers. Differences of Neuromuscular Activity.
Official title: Difference of Neuromuscular Activity in Infants and Toddlers With Foot Dorsiflexion Compare to Infants and Toddlers With Foot Plantarflexion
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Forefoot Adduction
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-05-08
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: infants and toddlers with Forefoot adduction

Brief summary: Every week we encounter with 5-8 pairs of worried parents of infants with forefoot adduction. Most of them usually need only reassurance and education how to manipulate the deformed foot. During the examination we usually use provocative maneuver to trigger peroneal activity. This manual stimulation usually reveals active eversion and dorsiflexion of the foot in most of the children, but not in all of them. Small part of the children reacts in opposite direction - instead of the typical eversion they demonstrate inversion and some plantar flexion of the foot. We have the impression that this subgroup of children improves the deformity slower and sometime less complete than most of the children. We did not find in the literature any description of this phenomenon. We postulate, that atypically reacting patients probably have different response due to abnormalities of neuromuscular balance between invertors-flexors and evertors-extensors muscle groups. This small subgroup of children may need more close follow-up and probably casting to speed up and secure the improvement of their deformity.

Study goals:

1. Evaluate ability of children with FFA to respond on mechanical triggering of peroneal activity

   1. The majority of the patients with standard reaction - foot dorsiflexion and eversion (evertors)
   2. The minority of the patients with nonstandard reaction - foot plantarflexion and inversion (invertors)
2. Evaluate randomly selected children from each group for character of muscular response on electrical stimulation (EMG) of calf muscles.


Eligibility criteria: Inclusion Criteria:

1. Boys and girls between two months and one year old.
2. Non associated pathology.
3. Signing Informed consent.

Exclusion Criteria:

1. Unwillingness to sign informed consent.
2. Associated pathology

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization.
Study officials:
affiliation: Hadassah Medical Organization
name: Naum Simanovski, MD
role: PRINCIPAL_INVESTIGATOR
References: