louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01520181: Extended Open Challenge in Patients With a History of Drug Eruption Following Beta-lactam Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Beta-lactam Allergy
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2012-01-27
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Beta-lactam allergy is the most prevalent drug allergy. Drug eruption is the most common symptom whereas life-threatening anaphylaxis is rather rare. A recently published study (Journal of Allergy and Clinical Immunology, January 2011, Vol. 127, p. 218-222) described the safety of a 2-day oral beta-lactam challenge in penicillin-allergic patients, disregarding their penicillin skin test results. In the proposed study the investigators will similarly challenge beta-lactam allergic patients, both children and adults for an extended (5 days) period of time. The study will include patients with a history of a skin rash following beta-lactam administration as well as patients who cannot provide any data on their presumed allergic reaction, disregarding their penicillin skin test results.


Eligibility criteria: Inclusion Criteria:

* History of skin rash following the administration of beta-lactam antibiotic
* Patients with a diagnosis of penicillin allergy who have no data on the nature of the symptoms that have eventually resulted in establishing this diagnosis

Exclusion Criteria:

* Patients in whom the rash appeared within 1 hour after the last dose of the drug
* Patients who also developed other anaphylactic symptoms
* Patients who had a life-threatening rash such as Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis or DRESS.
* Pregnancy

Primary outcomes:
measure: The safety of a 5-day oral challenge in patients with suspected beta-lactam allergy
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: Arnon Goldberg, Allergy and Clinical Unit, Meir Medical Center
Study officials:
References:
Clinical trial NCT02292381: Blood Flow Regulation in Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2014-11-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 60 open angle glaucoma patients 60 healthy age- and sex matched controls

Brief summary: Glaucoma is one of the leading causes for blindness in industrialized countries. It is characterized by a progressive loss of retinal ganglion cells, morphological changes in the optic nerve head and a characteristic loss of visual field. Although increased intraocular pressure has been identified as the major risk factor for the development and the progression of the disease it has been speculated for a long time that impaired ocular blood flow may contribute to the pathogenesis of the disease. This concept has been supported by several epidemiological studies showing that low ocular perfusion pressure and small retinal vessel caliber are associated with the disease.

The proposed study tests the hypothesis that patients with glaucoma have reduced total retinal blood flow as compared to healthy subjects. Additionally, autoregulation of blood flow will be investigated during an increase in ocular perfusion pressure. This is of importance because it may clarify the degree of vascular involvement in glaucoma.


Eligibility criteria: Inclusion Criteria:

Patients with open angle glaucoma:

- Diagnosis of manifest open angle glaucoma as defined as pathological optic disc appearance, glaucoma hemifield test outside normal limits and/or untreated intraocular pressure ≥ 21 mmHg on at least three measurements in the medical history. Mean deviation in the visual field test \< 10 decibel

Healthy control subjects:

* normal ophthalmic findings and intraocular pressure \< 20 mmHg on at least three measurements
* no evidence of increased intraocular pressure in the medical history
* no signs of glaucomatous damage in the optic disc or the glaucoma hemifield test

Exclusion Criteria:

* Presence or history of a severe medical condition as judged by the investigator
* Abuse of alcoholic beverages
* Participation in a clinical trial in the 3 weeks preceding the study
* Exfoliation glaucoma
* Pigmentary glaucoma
* Secondary glaucoma
* Ocular hypertension
* History of acute angle closure
* Intraocular surgery within the last 6 months
* History of epilepsia
* Diabetes mellitus
* Ocular inflammation or infection within the last 3 months
* Untreated hypertension with systolic blood pressure \>160 mmHg, diastolic blood pressure \>95 mmHg
* Pregnancy or lactating

Primary outcomes:
measure: Optic nerve head blood flow
timeFrame: once
Secondary outcomes:
measure: Retinal blood flow
timeFrame: once
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT05447572: FIT Combining FC for Predicting MH and Histology Remission in UC
Official title: FIT Combining FC for Predicting MH and Histology Remission in UC
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ulcerative Colitis
Histology Remission
Fecal Calprotetin
FIT
Mucosal Healing
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ulcerative colitis patients.

Brief summary: Investigaters will perform a clinical trial to asess the abilitiy of qFIT and FC on predicting UC MH and histology remission.


Eligibility criteria: Inclusion Criteria:

* Ulcerative colitis patients.

Exclusion Criteria:

* GI bleeding

Primary outcomes:
measure: diagnostic value of FIT and/without FC on predicting MH
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hospital of Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT02938572: A Randomised Proof-of-Principle Trial Investigating Pharmacodynamics, Pharmacokinetics, and Safety of NNC0143-0406 in Subjects With Type 1 Diabetes Mellitus
Official title: Proof-of-Principle Trial Investigating Pharmacodynamics, Pharmacokinetics, and Safety of NNC0143-0406 in Subjects With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2016-10-19
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate Pharmacodynamics (the effect of the investigated drug on the body) , Pharmacokinetics (the exposure of the trial drug in the body), and Safety of NNC0143-0406 in Subjects with Type 1 Diabetes Mellitus


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18-55 years (both inclusive) at the time of signing informed consent
* Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening
* Treated with continuous subcutaneous insulin infusion at least 90 days prior to the day of screening

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product(s) or related products
* Males who are sexually active and not surgically sterilised (vasectomy or otherwise) and their partners that are not using a highly effective contraception method, from randomisation until 90 days after dosing, such as double barrier contraception (e.g. condom and spermicide) or combination of either an oral ontraceptive, a contraceptive patch, a diaphragm or intrauterine device, together with a physical barrier such as condom. Male subjects must also agree to refrain from sperm donation from randomisation until 90 days after last dosing
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) (adequate contraceptive measures are defined as sterilisation, hormonal intrauterine device, oral contraceptives, condom with spermicide sexual abstinence or vasectomised partner)

Primary outcomes:
measure: The ratio of suppression of endogenous glucose production relative to total glucose lowering effect
timeFrame: Two weeks of treatment
Secondary outcomes:
measure: Number of treatment emergent adverse events
timeFrame: Time of first trial product administration to 7 days (7 times 24 hours) after last trial product administration
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02074072: Endotracheal Intubation Using Three Laryngoscopes in Maternal Cardiac Arrest: a Manikin Simulation Study
Official title: Comparison of Glidescope, Pentax-AWS and Macintosh Laryngoscope for Intubation During Chest Compression in 15-30 Degree Left-Lateral Tilt: A Manikin Simulation Study of Maternal Cardiopulmonary Resuscitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: Endotracheal intubation
Left lateral tilt wedge
Maternal Cardiopulmonary Resuscitation
Manikin Study
Lead sponsor: Hanyang University Seoul Hospital
Sponsor class: OTHER
First posted: 2014-02-28
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: European Resuscitation Council (ERC) Guidelines for Resuscitation 2010 emphasize high quality chest compressions .They propose minor changes for pregnant women: manual left deviation of the uterus or a left-lateral incline of 15-30to alleviate pressure on the inferior vena cava. We will examine the performance of the Glidescope (GVL), the Pentax-AWS Airwayscope(AWS) and Macintosh laryngoscope (McL) for airway management during chest compressions on 15 and 30 degree left-lateral tilt (15 \&30 LLT) custom-made hard wedges.

Detailed description: Materials

1. Sim Mom manikin (Laerdal, Stavanger, Norway)
2. Stryker ST104-747(Transport stretcher®, 760 x 2110 mm, 228 kg, Stryker Co., Kalamazoo, Michigan, US)
3. LUCAS Chest Compression System( LUCAS Chest Compression System, Physio-Control/Jolife AB)
4. Backboard(450 ×600 ×10 mm, 3 kg Lifeline Plastic, Sung Shim Medical Co., Bucheon, Korea)

Eligibility criteria: Inclusion Criteria:

* Experience of intubation \> 50 times
* Postgraduates year 1,2,3,4 and Emergency physicians in emergency department

Exclusion Criteria:

* Wrist or Low back disease

Primary outcomes:
measure: Time to intubation
timeFrame: 1day
measure: Success rate of intubation
timeFrame: 1day
Secondary outcomes:
measure: Laryngeal View during intubation
timeFrame: 1day
measure: The preference for laryngoscopes
timeFrame: 1day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
Study officials:
affiliation: Hanyang University Seoul Hospital
name: Sang hyun Lee, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01408472: NT-501 CNTF Implant for Glaucoma: Safety, Neuroprotection and Neuroenhancement
Official title: CNTF Cell Implants For Glaucoma: A Phase I Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glaucoma, Primary Open Angle
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-08-03
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ciliary Neurotrophic Factor (CNTF) has been demonstrated in multiple pre-clinical models to enhance survival and regeneration of retinal ganglion cells, the retinal neurons injured in diseases like glaucoma. We hypothesize that CNTF delivery to the human eye will provide neuroprotection (prevent loss of vision) and neuroenhancement (improve vision indices) in glaucoma. Patients in the trial will receive an NT-501 CNTF implant (made by Neurotech) into one eye, and will be carefully followed to evaluate safety and efficacy.


Eligibility criteria: Inclusion Criteria:

* must understand and sign the informed consent
* must be medically able to undergo ophthalmic surgery for the NT-501 device insertion and possible removal, as well as the testing required.
* diagnosis of glaucoma characterized by (a) clinical evidence of progressive RGC dysfunction and degeneration using both visual field and at least one structural modality; (b) residual visual field preservation including best-corrected visual acuity (BCVA) better than 20/100; (c) failure to contain glaucomatous progression with maximally tolerated reduction of intraocular pressure (IOP), OR visual field defect affecting fixation, but not reducing BCVA below 20/100.

Exclusion Criteria:

* other corneal, lens, optic nerve or retinal disease causing vision loss,
* blind in one eye
* requirement of acyclovir and/or related products during study
* receiving systemic steroids or other immunosuppressive medications.
* pregnant or lactating.
* considered immunodeficient or has a known history of human immunodeficiency virus (HIV)
* on chemotherapy, or a history of malignancy, UNLESS it was treated successfully 2 years prior to inclusion in the trial.

Primary outcomes:
measure: Safety: Number of adverse events
timeFrame: 18 months
Secondary outcomes:
measure: Functional Efficacy: Vision, Visual Field, Pattern Electroretinogram; Visual Field Questionnaire-25
timeFrame: 18 months
measure: Structural Efficacy: Nerve fiber layer, optic nerve topography
timeFrame: 18 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Bascom Palmer Eye Institute, University of Miami
state: Florida
Study officials:
affiliation: Bascom Palmer Eye Institute, University of Miami
name: Jeffrey L Goldberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03904472: Cognitive Behavioral Therapy for Insomnia (CBTI) in GERD Patients With Insomnia
Official title: Single-arm Pilot Trial of Web-based Cognitive Behavioral Therapy for Insomnia (CBTI) in Gastroesophageal Reflux Disease (GERD) Patients With Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Keywords: cognitive behavioral therapy
GERD
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: American Gastroenterological Association
First posted: 2019-04-05
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will enroll patients with persistent reflux symptoms despite proton-pump inhibitor therapy and chronic insomnia. Participants that are eligible for the study and agree to participate will receive cognitive behavioral therapy for insomnia (CBTI) delivered by a web-based approach. The goal of the treatment is to improve the participants insomnia and reflux symptoms. In addition to the cognitive behavioral therapy, participants will be asked to keep a daily diary and periodically complete questionnaires to assess their symptoms.


Eligibility criteria: Inclusion Criteria:

* Patients with persistent reflux symptoms (GERDQ \>8) despite proton-pump inhibitor (PPI) therapy.
* Patients screened positive for chronic insomnia (insomnia severity index \[ISI\] ≥15).

Exclusion Criteria:

* Patients with major esophageal motility disorder, prior foregut surgeries, severe cardiopulmonary diseases, or major psychological comorbidities.
* Patients who report being in "poor" or "very poor" physical or mental health.
* Patients with sleep apnea (based on STOP-BANG questionnaire \>4)
* Patients with AUDIT score \>15, indicating alcohol dependence
* Patients regularly taking medications for sleep \>2 times per week who cannot stop the sleep aid at least 4 weeks prior to and during the study trial.
* Patients who have previously undergone CBT for insomnia (in person or online).

Primary outcomes:
measure: Reflux Symptom Questionnaire-7-day recall (RESQ-7)
timeFrame: up to 8 weeks post treatment
measure: Gastroesophageal Reflux Disease Quality of Life (GERD-QoL)
timeFrame: up to 8 weeks post treatment
Secondary outcomes:
measure: Insomnia severity index (ISI)
timeFrame: up to 8 weeks post treatment
measure: Sleep Onset Latency (SOL)
timeFrame: up to 8 weeks post treatment
measure: Wake After Sleep Onset (WASO)
timeFrame: up to 8 weeks post treatment
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan GI Physiology Lab
state: Michigan
Study officials:
affiliation: University of Michigan
name: Joan Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05707572: Morton's Neuroma: Manipulation Versus Steroid Injection
Official title: Manipulation Versus Steroid Injection in the Treatment of Morton's Neuroma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morton Neuroma
Keywords: manipulation
plantar digital neuritis
morton's neuroma
nerve entrapment
foot
Lead sponsor: Dundee Podiatry Clinic
Sponsor class: OTHER
Collaborators: name: Queen Margaret University
First posted: 2023-02-01
Enrollment: 62
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: This study compares manipulative therapy to steroid injection in the treatment of Morton's Neuroma.

Detailed description: The aim of this study is to establish whether manipulative therapy is an effective treatment for Morton's neuroma, a nerve entrapment in the foot. Steroid injection is the current gold standard conservative treatment for this condition. Therefore, a subject group shall be compared to a steroid injection intervention group. Outcomes will be compared using visual analogue pain scales -VAS, Foot Function Index questionnaires and algometric pressure threshold testing. An improvement in the manipulation group VAS of 20mm above the injection group shall be considered as the minimum worthwhile change as this has been identified as the minimum clinically important difference in pain between treatment groups in visual analogue pain scales.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of morton's neuroma
* over 18 years of age
* presenting VAS score \> 30mm

Exclusion Criteria:

* diabetes,
* rheumatoid arthritis
* fibromyalgia.
* Those currently taking Statins or analgesics
* previous neuroma surgery

Primary outcomes:
measure: Visual analogue pain scale
timeFrame: pre treatment at each clinic visit and then 3,6,9 and 12 months
Secondary outcomes:
measure: Algometric pressure threshold meter
timeFrame: pre treatment at each clinic visit and then 3,6,9 and 12 months
Other outcomes:
measure: Foot function index questionnaire
timeFrame: pre treatment at each clinic visit and then 3,6,9 and 12 months
measure: Manchester Oxford Foot Pain Questionnaire
timeFrame: pre treatment at each clinic visit and then 3,6,9 and 12 months
measure: Short Form 36 pain and disability Questionnaire
timeFrame: pre treatment at each clinic visit and then 3,6,9 and 12 months
Locations:
city: Edinburgh
country: United Kingdom
facility: Podiatry Department NHS Lothian
state: Lothian
Study officials:
affiliation: Queen Margaret University
name: David G Cashley, BSc(Hons)Pod
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00152672: Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance
Official title: Treatment of Sleep Apnea Syndrome With nCPAP Versus Oral Appliance: a Multicentre Prospective Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea Syndrome
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2005-09-09
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This prospective randomized cross over study aims to compare nCPAP with mandibular advancement device for the treatment of sleep apnea syndrome.The effectiveness of nCPAP and oral appliance on apnea-hypopnea index, daytime sleepiness and quality of life will be compared in 60 patients.


Eligibility criteria: Inclusion Criteria:

18 to 70 years old BMI \< 35 kg/m2 Apnea-hypopnea index between 10 and 60 events/h Complaint of snoring and sleepiness Dental status adequate for treatment with oral appliance informed consent

Exclusion Criteria:

psychiatric disease professional driver other cause of sleepiness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU
Study officials:
affiliation: UH Angers
name: Frédéric Gagnadoux
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00728572: Logan Basic Technique Measured by Surface Electromyography (EMG)
Official title: The Effect of Logan Basic Technique Apex Contact Adjustment on the Motor Recruitment Pattern in the Erector Spinae.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Spinal Manipulation
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2008-08-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this investigation is to determine the effect of Logan Basic Technique apex contact adjustment (LBT); on the motor recruitment pattern in the erector spinae group via surface EMG.

Detailed description: LBT is a low force adjusting technique that focuses on the foundation segment of the spine, the sacrum, with application of contact on the sacrotuberous ligament which relieves fatigued and strained muscles, particularly intrinsic muscles of the back. Surface electromyography (EMG) is a method of analyzing the activity level of superficial muscles. It is convenient and advantageous when studying muscle relaxation which occurs in biofeedback studies

Eligibility criteria: Inclusion Criteria:

* Students in trimesters 1 - 3.
* Naive to the Logan Basic Technique adjusting protocol.

Exclusion Criteria:

* Students in trimesters 4 - 10.
* Pregnant females or females who can possibly be pregnant.

Primary outcomes:
measure: Surface EMG
timeFrame: 15 minute sEMG: 5 mins before, 5 mins during and 5 mins after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Logan University, College of Chiropractic
state: Missouri
Study officials:
References: