louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02161835: Relations Between Myotonia and Fitness
Official title: Relations Between Fitness Status and the Severity of Myotonia in Patients With Congenital Myotonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Myotonia
Keywords: Congenital myotonia
Myotonia congenita
Thomsons disease
Becker type
Training
Exercise
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-06-12
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators aimed to investigate whether training can increase fitness levels in patients with myotonia, and thereby reduce the symptom of myotonia.

Detailed description: Investigators aimed to investigate whether a 10-week bicycle exercise program can increase fitness levels in patients with myotonia, and thereby reduce the symptom of myotonia in everyday life. The effect on myotonia is assessed by a standardized myotonia scale with six statements concerning self-rated myotonia, and a number of performance tests that objectively describes the degree of myotonia.

The effect of the training program is assessed by an incremental test, measuring maximal oxygen uptake, maximal heart rate and maximal workload. The muscle enzyme creatine kinase (CK) is measured in plasma to follow muscle injury and safety during the training.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with either Myotonia congenita or Paramyotonia congenita.
* Patients who have symptoms of myotonia while they are walking stairs.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Physical or mental condition, which prevent participating in the study protocol or which could influence the results.
* Participating in other studies, which could influence the results.

Primary outcomes:
measure: Changes in myotonia
timeFrame: Week 0 and week 10
Secondary outcomes:
measure: Changes in fitness
timeFrame: baseline and after week 10
measure: Changes in creatine Kinase
timeFrame: baseline, week 2, week 4, week 7 and week 10
measure: Changes in other myotonia
timeFrame: baseline and after week 10
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Neuromuscular Research Unit, Department of Neurology, Rigshospitalet
Study officials:
affiliation: Neuromuscular research unit Copenhagen
name: Grete Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03247335: Follow-up of Arthrosurface HemiCAP Implants
Official title: Follow-up of Arthrosurface HemiCAP Implants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthopedic Disorder
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Arthrosurface, Inc.
First posted: 2017-08-11
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who had Arthrosurface (Franlin, MA) HemiCAP implants placed into their shoulders at the Cleveland Clinic

Brief summary: Follow-up of Arthrosurface HemiCAP shoulder implants.

Detailed description: In summary, the investigators would like to contact all patients who have had HemiCAP implants done at CCF with at least 2 years of follow-up after their procedure. The investigators will use electronic or written means to alert the patients that they will be contacted by our team to discuss their surgery and any related issues. Once the appropriate consent is obtained, the investigators will use a brief telephone interview to ask the patients several questions regarding any re-operations or complications the patients have had since the index procedure.

Eligibility criteria: Inclusion Criteria:

-Patients who had Arthrosurface (Franlin, MA) HemiCAP implants placed into their shoulders at the Cleveland Clinic

Exclusion Criteria:

* Anyone who has not had ARthrosurface (Franlin, MA) HeiCAP implants placed into their shoulders at the Cleveland Clinic

Primary outcomes:
measure: Arthrosurface
timeFrame: 2 year
Secondary outcomes:
measure: Rate of revision surgeries
timeFrame: 2 year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Kurt Spindler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00410735: Study of ONO-1078 in Patients With Chronic Sinusitis
Official title: Study of ONO-1078 in Patients With Chronic Sinusitis, a Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Sinusitis
Keywords: ONO-1078
chronic sinusitis
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2006-12-13
Enrollment: 495
Sex: ALL
Minimum age (years): 15
Maximum age (years): 74
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the efficacy and safety of ONO-1078 in patients with chronic sinusitis in a double-blind, randomized, placebo-controlled, parallel group, multi-center study


Eligibility criteria: Inclusion Criteria:

* chronic sinusitis

Exclusion Criteria:

* acute sinusitis
* chronic sinusitis with acute exacerbation

Primary outcomes:
measure: nasal congestion
timeFrame: 12 weeks
measure: rhinorrhea
timeFrame: 12 weeks
measure: postnasal drip
timeFrame: 12 weeks
Secondary outcomes:
measure: easiness of blowing nose
timeFrame: 12 weeks
measure: easiness of removing postnasal drip
timeFrame: 12 weeks
measure: dull headache
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
facility: Chubu region
city: Hokuriku
country: Japan
facility: Hokuriku region
city: Kanto
country: Japan
facility: Kanto region
city: Kinki
country: Japan
facility: Kinki region
city: Kyushu
country: Japan
facility: Kyushu region
city: Tohoku
country: Japan
facility: Tohoku region
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Hajime Yamamotoya
role: STUDY_DIRECTOR
References:
Clinical trial NCT03412435: Asan Medical Center Myocardial Infarction Registry
Official title: Asan Medical Center Myocardial Infarction Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Infarction, Acute
Coronary Stenosis
Keywords: Acute myocardial infarction
Myocardial infarction
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2018-01-26
Enrollment: 5000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive acute myocardial infarction patients diagnosed through coronary angiography

Brief summary: This study evaluates long-term outcome of patients diagnosed as acute myocardial infarction and treated with medication, coronary artery bypass surgery and percutaneous coronary intervention in Asan medical center, Korea.

Detailed description: This study will collect 3000 cases retrospectively and 2000 cases prospectively.

Eligibility criteria: Inclusion Criteria:

* All consecutive acute myocardial infarction patients diagnosed through coronary angiography

Primary outcomes:
measure: A composite event of all-cause death, non-fatal myocardial infarction and repeat revascularization
timeFrame: 1 year
Secondary outcomes:
measure: All cause death
timeFrame: 5 year
measure: Cardiac death
timeFrame: 5 year
measure: Myocardial infarction
timeFrame: 5 year
measure: A composite event of all-cause death and myocardial infarction
timeFrame: 5 year
measure: A composite event of cardiac death and myocardial infarction
timeFrame: 5 year
measure: Repeat revascularization
timeFrame: 5 year
measure: Stent thrombosis
timeFrame: 5 year
measure: Stroke
timeFrame: 5 year
measure: Procedure success
timeFrame: 7 days
measure: Surgery success
timeFrame: 7 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT01497535: Within-subject Variability of Insulin Detemir in Healthy Volunteers
Official title: A Single-centre, Parallel-group, Randomised, Double Blind Trial in Healthy Japanese Subjects Comparing the Within-subject Variability of Insulin Detemir and Insulin Glargine With Respect to Pharmacodynamic and Pharmacokinetic Properties
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-22
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: This trial is conducted in Europe. The aim of this trial is to compare the within-subject variability of insulin detemir to that of another basal insulin analogue, insulin glargine in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese men or women
* Holding a Japanese pass-port and Japanese-born parents
* Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
* Body Mass Index (BMI) between 18 and 30 kg/m\^2, incl.
* Fasting blood glucose maximum 6 mmol/L

Exclusion Criteria:

* Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator
* Any serious systemic infectious disease that occurred during the four weeks prior to the first dose of the trial product, as judged by the Investigator
* Subject with history of alcohol or drug dependence

Primary outcomes:
measure: Maximum glucose infusion rate (GIRmax)
Secondary outcomes:
measure: Area under the glucose infusion rate curve (AUCGIR)
measure: Time to maximum glucose infusion rate (tGIRmax)
measure: Area under the insulin concentration curve (AUC)
measure: Maximum insulin concentration (Cmax)
measure: Adverse events
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00960635: Immunointervention With Calcitriol in New-Onset Type 1 Diabetes
Official title: Immunointervention With 1,25-dihydroxy-vitamin D3 in New-onset Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 1 Diabetes
Keywords: new-onset
Lead sponsor: Institut fur Diabetesforschung, Munich, Germany
Sponsor class: OTHER
First posted: 2009-08-18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Primary purpose: PREVENTION

Brief summary: This is a randomized, two-arm, placebo-controlled phase-2 trial to determine whether the daily intake of 1,25-dihydroxy-vitamin D3 \[1,25(OH)2D3\], improves beta cell function in patients with recently diagnosed type 1 diabetes. The treatment consists of the daily oral administration of 0.25 µg 1,25(OH)2D3 or placebo for 9 months and an equal follow-up time without supplementation. Fasting, peak and AUC C-peptide concentrations during a 2-hour mixed meal tolerance test are measured at the beginning of the study, as well as at the end of the treatment and the follow-up period in month 9 and 18. The null hypothesis is that there is no difference between 1,25(OH)2D3 treated subjects and the placebo group in the AUC C-peptide at month 18.


Eligibility criteria: Inclusion Criteria:

* New onset Typ 1 diabetes (\< 6 weeks insulin therapy)
* Age 18-39 years
* GADA and/or IA-2A positive

Exclusion Criteria:

* Kidney disease
* Pregnancy
* Lactating

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Institut fuer Diabetesforschung
Study officials:
affiliation: Institut fuer Diabetesforschung
name: Anette G Ziegler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walter M, Kaupper T, Adler K, Foersch J, Bonifacio E, Ziegler AG. No effect of the 1alpha,25-dihydroxyvitamin D3 on beta-cell residual function and insulin requirement in adults with new-onset type 1 diabetes. Diabetes Care. 2010 Jul;33(7):1443-8. doi: 10.2337/dc09-2297. Epub 2010 Mar 31.
Clinical trial NCT03712735: Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women
Official title: Effect of Programmed Intermittent Epidural Bolus Delivery Rate on the Quality of Labour Analgesia: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Labor Pain
Keywords: Labor analgesia
Programmed intermittent epidural bolus
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 390
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of three programmed intermittent epidural bolus (PIEB) pump settings for maintenance of labour analgesia.

Detailed description: The optimal PIEB and patient controlled epidural administered (PCEA) bolus settings are still unknown. Therefore, in this study, the investigators aim to compare analgesia outcomes both high and low PIEB flow rate settings.

Eligibility criteria: Inclusion Criteria:

* Singleton, vertex presentations at term (37-42 weeks gestational age)
* \</= 5cm cervical dilation at the time of epidural anesthesia request
* ASA 2-3 patients aged 19 or over who are able to provide informed consent

Exclusion Criteria:

* Contraindications to neuraxial analgesia or risk factors likely to affect placement or function of the epidural
* History of hypersensitivity or idiosyncratic reaction to local anesthetics or opioids
* Current or historical evidence of any significant medical conditions
* Clinical settings in which continuous epidural infusion may be preferable
* Risk factors significantly increasing the need for Cesarean delivery
* Anticipated fetal abnormalities

Primary outcomes:
measure: Breakthrough pain
timeFrame: Duration of labor with epidural
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Anton Chau, MD MMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02943135: Lidocaine In-situ Gel Before Intrauterine Device Insertion
Official title: Effect of Self-administered Lidocaine In-situ Gel on Intrauterine Device Insertion Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain Relief
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-10-24
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Intrauterine device can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the insertion tube, and removing the tube; and placement of the device in the uterus.


Eligibility criteria: Inclusion Criteria:

* Women not taken analgesics or anxiolytics in the 24 hours prior insertion
* Women not taken misoprostol prior to insertion
* No contraindication to or history of allergic reaction to lidocaine
* Women who will accept to participate in the study

Exclusion Criteria:

* Lidocaine allergy
* Any contraindication to device placement

Primary outcomes:
measure: Mean pain score during intrauterine device insertion
timeFrame: 30 min
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT04317235: Ultrasound-guided Interscalene Block:3mL Ropi Provide Similar Analgesia to 5mL and Less Diaphragmatic Paralysis
Official title: Ropivacaine for Ultrasound-guided Interscalene Block: 3mL Provide Similar Analgesia to 5mL With Less Diaphragmatic Paralysis in Shoulder Arthroscopy Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diaphragmatic Paralysis
Lead sponsor: Saint George Hospital
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ropivacaine for ultrasound-guided interscalene block: 3mL provide similar analgesia to 5mL with less diaphragmatic paralysis in shoulder arthroscopy surgeries

Detailed description: Ropivacaine for ultrasound-guided interscalene block: 3mL provide similar analgesia to 5mL with less diaphragmatic paralysis in shoulder arthroscopy surgeries with no toxicity and no adverse reaction or complications we targeted under echography each nerve to be blocked alone either to put around all the nerves a big volume

Eligibility criteria: Inclusion Criteria:

* ASA1-2

Exclusion Criteria:

* ASA3-4 anticoagulant

Primary outcomes:
measure: Diaphragmatic paralysis
timeFrame: Up to 48 hours
measure: Pain relief
timeFrame: up to day 2 after operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Saint George Hospital
name: hazem kafrouni
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01289158: Combined Malonic and Methylmalonic Aciduria (CMAMMA): Gene Identification and Outcome Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malonic Aciduria
Methylmalonic Acidemia
Keywords: malonic and methylmalonic aciduria
malonyl-coenzyme A decarboxylase
MLYCD
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2011-02-03
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Biochemical Genetics clinics patients with non-classical CMAMMA

Brief summary: The investigators are interested in learning more about the changes found in the condition called "Combined elevation of Malonic and MethylMalonic Acid, or CMAMMA. " Malonic, or MA and MethylMalonic, or MMA, are acids formed from the breakdown of protein under normal conditions. However, in the condition called CMAMMA there is an increase of these acids in the blood and urine, which is not normal.

Some people with high MA and MMA in their blood and urine have a serious disease, starting as a baby or young child that includes heart disease and problems in learning. These people have changes in a special enzyme called Malonyl CoA Decarboxylase (MCD). Other people who have a high level of MA and MMA do not have any obvious illness. The investigators are not sure why they have high levels of MA and MMA and why they are not sick.

The goal of this study is to learn more about why some people have a high level of MA and MMA and to make sure there are no medical problems as a result of these high levels. The investigators also want to find out which gene and enzyme cause the high levels of MA and MMA.


Eligibility criteria: Inclusion Criteria:

1. Elevated Malonic and Methylmalonic Acid in blood and urine
2. Any age
3. Any sex
4. Asymptomatic

Exclusion Criteria:

1. Defect in malonyl-coenzyme A decarboxylase (MCD) enzyme
2. History of metabolic acidosis, developmental delay and seizures

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
Study officials:
References:
Clinical trial NCT05761158: Study of the Characteristics of Pruritus in Patients With Frontal Fibrosing Alopecia or Lichen Planus Pilaris
Official title: Study of the Characteristics of Pruritus in Patients With Frontal Fibrosing Alopecia or Lichen Planus Pilaris
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Alopecia
Lichen Planus
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Major patients with frontal fibrosing alopecia or lichen planus pilaris, with scalp pruritus, followed in the Dermatology Department of the CHRU Brest and having given their consent to participate in the study.

Brief summary: The prevalence of pruritus has been studied in frontal fibrosis alopecia (FFA) and lichen planus pilaris (LPP), but there are no studies evaluating the characteristics of pruritus, the correlation between pruritus and disease activity, and its impact on quality of life.

The knowledge of the characteristics of pruritus, of the link "disease activity - pruritus", and its impact on the quality of life could allow us to modify the management of the patient (modification or intensification of therapy, close monitoring...)


Eligibility criteria: Inclusion Criteria:

* Major patient.
* Fibrosing frontal alopecia or lichen planus pilaris
* Presence of pruritus of the scalp : a positive response to the question "do you experience itchy scalp?"
* The patient received an information note and did not object to the study

Exclusion Criteria:

* Patients under 18 years of age.
* Other pathologies causing scalp pruritus (seborrheic dermatitis, contact dermatitis, lupus, Quinquaud's decalcifying folliculitis, ectoparasitosis, scalp psoriasis, ringworm, red sclap syndrome, dermatomyositis, central centrifugal cicatricial alopecia (CCCA))
* Refusal to participate by the patient.
* Patient under legal protection (curatorship, guardianship, ...)
* Patient not covered by social security

Primary outcomes:
measure: Study of the characteristics of pruritus in patients with frontal fibrosis alopecia or lichen planus pilaris
timeFrame: Hour1
measure: Study of the characteristics of pruritus in patients with frontal fibrosis alopecia or lichen
timeFrame: Hour1
Secondary outcomes:
measure: Study the relationship between disease activity (AFF or LPP) and pruritus, as well as the impact of pruritus on patients' quality of life.
timeFrame: Hour1
measure: Study the relationship between disease activity (AFF or LPP) and pruritus, as well as the impact of pruritus on patients' quality of life.
timeFrame: Hour1
measure: Study the relationship between disease activity (AFF or LPP) and pruritus, as well as the impact of pruritus on patients' quality of life.
timeFrame: Hour1
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU Brest
Study officials:
References: