louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00438399: Subject Preference for Scalp Psoriasis Treatment
Official title: Subject Preference Comparison Between Clobetasol Propionate Shampoo, 0.05% and Three Other Topical Corticosteroids in the Treatment of Moderate to Severe Scalp Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Scalp Psoriasis
Keywords: 1 Galderma,
2 Scalp Psoriasis
3 Subject preference
4 Clobetasol propionate
5 Shampoo
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2007-02-22
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The scalp is one of the most common affected sites in psoriatic patients as 79% of them have scalp involvement.It has also a psychological aspect with 31% of patients with scalp psoriasis indicating distress.

Topical agents remain the mainstay of treatment for scalp psoriasis. However, they are not always ideal because they might be inconvenient and messy to use, stain or damage hair.

The test shampoo, Clobetasol propionate Shampoo 0.05% (marketed in the USA under the tradename of Clobex®) was developed to provide the strongest available corticosteroid as a short-contact therapy in order to improve the chances of it being effective and reduce the potential for traditional side-effects.

The objective of this study is to compare subject's overall preference between Clobetasol propionate shampoo 0.05% and three other topical corticosteroids in the treatment of moderate to severe scalp psoriasis.

Detailed description: This study will be a multi-centre, investigator blinded, randomized, cross-over, intra-individual comparison in three parallel groups.

In each parallel group, Clobetasol propionate shampoo, 0.05% will be compared to one of the three chosen competitors, following a cross-over design.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects, 18 years of age or older,
* Subjects with moderate to severe scalp psoriasis,
* Subjects who signed written informed consent prior to any study procedures.

Exclusion Criteria:

* Subjects who need systemic treatment for their body psoriasis,
* Subjects who are at risk in terms of precautions, warnings and contra-indication,
* Female subjects who are pregnant, nursing or planning a pregnancy during the study,
* Subjects with a specific washout period for topical treatment(s) on the scalp,
* Subjects with a specific washout period for systemic treatment(s).

Primary outcomes:
measure: Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator
timeFrame: End of period II (up to 16 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Clinica Dermatologica Azienda Ospedaliera Policlinico di Modena
Study officials:
affiliation: Clinica Dermatologica Azienda Ospedaliera Policinico di Modena - Italy
name: Alberto Giannetti, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02839499: Screening of Obstructive Sleep Apnea Syndrome in Residents of a Unit of Long-term Care Under Mixed Food
Official title: Screening of Obstructive Sleep Apnea Syndrome in Residents of a Unit of Long-term Care Under Mixed Food
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: seniors
mixed food
normal texture food
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 39
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Obstructive sleep apnea is a condition that affects 40% to 62% of the population aged over 60 years with major consequences especially on the cardiovascular system.

This syndrome consists of a staff of the pharyngeal muscles. These muscles are also involved in swallowing phenomena and chews, or many elderly patients are subjected to a mixed diet, logically leading to atrophy of the muscles aerodigestive crossroads.

Muscle wasting ENT induced a mixed food could promote collapsibility of VAS, exposing the individual to a higher risk of apnea and hypopnea during sleep.

The objective of this study is to determine if there is a significant increase in the prevalence of obstructive sleep apnea syndrome in the elderly patients residing in long term care units, receiving a mixed food compared to residents in supply to normal texture.


Eligibility criteria: Inclusion Criteria:

* Resident of a unit of long-term care
* Recipient or affiliated with Social Security
* Signature of consent by the patient, guardian or person of trust

and mixed food or normal texture food

Exclusion Criteria:

* OSA diagnosed and treated earlier
* Patients with an abnormal upper airway out edentation
* Patients unable to give informed consent and having no confidence in individual capacity to do so.
* Patients with a gastrostomy or jejunostomy

Primary outcomes:
measure: measure of the index of respiratory events
timeFrame: up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: CHU de Saint Etienne
Study officials:
affiliation: CHU de Saint Etienne
name: Emilie CRAWFORD-ACHOUR, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02530099: Simulation-based Training of Operating Assistants: Procedure- Versus Camera Navigation Training
Official title: Simulation-based Training of Operating Assistants: Procedure- Versus Camera Navigation Training - a Randomized Controlled Trial Examining Clinical Transfer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Simulation Training
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2015-08-20
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: Often the less experienced as medical students are charged with the role as camera navigator and assistant during laparoscopic surgery. Camera navigation is generally considered an easy skill, but it requires specific psychomotor and visuospatial skills. Simulation-based training can improve surgical skills, but little is known on how to optimally structure a training program to acquire camera navigation skills. The objective of this trial is to examine if simulation-based laparoscopic camera navigation skills transfer to the operating room after practicing one of two fundamentally different laparoscopic tasks on a simulator. The first group practice a procedure on a virtual reality simulator, the second group practice camera navigation on a virtual reality simulator and the third group receive no training. All participants are tested as camera navigators and assistants during a procedure in the operating room.


Eligibility criteria: Inclusion Criteria:

* Medical students on the 4th, 5th or 6th semester, enrolled at The Faculty of Health Science, University of Copenhagen
* Signed informed consent

Exclusion Criteria:

* Previous participation in trials involving simulated laparoscopic training.
* Experience with laparoscopy surgery (having performed minimum one laparoscopic procedure as primary surgeon or as a surgical assistant).
* No informed consent.
* Does not speak Danish on a conversational level.

Primary outcomes:
measure: Surgeons' rating on camera navigation performance during a procedure in the operating room.
timeFrame: up to 1-3 weeks post training
Secondary outcomes:
measure: Score on the intrinsic motivation inventory-scale
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References:
citation: Nilsson C, Sorensen JL, Konge L, Westen M, Stadeager M, Ottesen B, Bjerrum F. Simulation-based camera navigation training in laparoscopy-a randomized trial. Surg Endosc. 2017 May;31(5):2131-2139. doi: 10.1007/s00464-016-5210-5. Epub 2016 Oct 21.
Clinical trial NCT03189199: A Registry Study on Safety Surveillance of Dazhuhongjingtian (a Chinese Medicine Injection) Used in China
Official title: A Registry Study on Safety Surveillance of Dazhuhongjingtian (a Chinese Medicine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Heart Disease
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Hospital of Changchun University of Traditional Chinese Medicine
First posted: 2017-06-16
Enrollment: 3000
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: An anticipated sample size was caculated in this study, about 3000. Patients using Dazhuhongjingtian injection from 2017 to 2019 in 4 hospitals

Brief summary: The purpose of this study is to make a cohort event monitoring to see whether and how Dazhuhongjingtian injection in hospital results in adverse events or adverse drug reactions

Detailed description: Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out ,because in mainland China hospitals ,Chinese Medicine Injection are used widely. Population for taking medicine characteristics,the incidence rate of ADR and other uncertain factors influence can few be found now.A registry study for Dazhuhongjingtian injection safety surveillance with 3000 patients will be conducted from June.2017 to Dec.2019.Eligibility criteria Patients who will use Dazhuhongjingtian injection in 4 selected hospitals from2017-2019.

Eligibility criteria: Inclusion Criteria:

- An anticipated sample size was caculated in this study, about 3000. Patients using Dazhuhongjingtian injection from 2017 to 2019 in 4 hospitals

Exclusion Criteria:

none

Primary outcomes:
measure: Incidence of Dazhuhongjingtian's ADRs,especially number of participants with adverse events.
timeFrame: The registry procedure will last about 3 years only for patients using Dazhuhongjingtian
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Yan Ming Xie, BA
role: STUDY_CHAIR
References:
Clinical trial NCT04221399: Type 2 Diabetes Patients With Renal Impairment
Official title: A Single- and Multiple-Dose Clinical Study to Evaluate Pharmacokinetics and Pharmacodynamics of DWP16001 Following Oral Dose in Type 2 Diabetes Patients With Renal Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type2 Diabetes
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2020-01-09
Enrollment: 35
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effect of kidney function on pharmacokinetics and pharmacodynamics of DWP16001 following single and multiple oral doses in type 2 diabetes patients with normal kidney function and renal impairment.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 19 years at the time of screening test
* Body weight of ≥ 50.0 kg to ≤ 90.0 with a body mass index (BMI) of ≥ 20.0 to ≤ 45.0
* Have been diagnosed with type 2 diabetes

Exclusion Criteria:

* Have clinically uncontrolled or unstable hepatic, neurological, immune system, respiratory, hemato-oncology, cardiovascular, or psychiatric disorder (subject with chronic disease such as hypertension, diabetes, and hyperlipidemia that is well controlled or stable is eligible to participate in the study based on investigator's judgement)
* History of gastrointestinal diseases, dialysis, kidney transplantation, HIV, hepatitis B or C, acute or chronic infection, recent diabetic ketoacidosis, or gastrointestinal surgery that may affect the absorption of the study drug
* Received SGLT2 inhibitors or drugs of thiazolidinedione class within 6 weeks of scheduled IP administration day
* Clinical laboratory test values are outside the accepted normal range at screening

  * AST (SGOT), ALT (SGPT) \> 2 x the upper limit of normal
  * Repeatedly confirmed QTc interval \> 450 ms
* Sitting systolic blood pressure \< 80 mmHg or \> 180 mmHg or sitting diastolic blood pressure \< 60 mmHg or \> 110 mmHg after resting for more than 3 minutes
* Other exclusive inclusion criteria, as defined in the protocol

Primary outcomes:
measure: Maximum Plasma Concentration [Cmax]
timeFrame: on Days 1 to 4 at selected time points
measure: Concentration-time curve [AUC]
timeFrame: on Days 1 to 4 at selected time points
measure: Urine glucose (g/day)
timeFrame: on Days -1 to 4
measure: Concentration of serum glucose
timeFrame: on Days 1 to 4 at selected time points
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01627899: One Touch VerioIQ US Clinical Outcomes Study
Official title: One Touch VerioIQ US Clinical Outcomes Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes
Keywords: Blood glucose monitor
Pattern management
Pattern guide
Education
Lead sponsor: LifeScan
Sponsor class: INDUSTRY
First posted: 2012-06-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Evaluation of the clinical benefits of One Touch VerioIQ system

Detailed description: Evaluation of the clinical benefits of the One Touch VerioIQ system. The system contains pattern alert technology and comes with educational material (Pattern guide) which provides additional support and insights to patients and health care providers to help them make more informed decisions during blood glucose management.

Eligibility criteria: Inclusion Criteria:

* male or female at least 18 to 80 years old
* ADA guidelines for FPG and PPG appropriate
* A1C greater or equal to 8.0% and less than or equal to 10.5%
* lab A1C greater than or equal to 8.0% in the last 6-12mths
* Diagnosed with type 1 or 2 in at least last 1 year
* on stable dose of OADs for at least 3mths prior to screening
* willingness to test 7 BGM tests per day
* willing to remain on same therapy as baseline (MDI) for duration of study

Exclusion Criteria:

* unlikely to be compliant to study procedures
* has or has currently used One Touch VerioIQ
* Is on fixed doses of insulin for MDI therapy

Primary outcomes:
measure: Change in A1C From Baseline to Week 24
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in A1C From Baseline to Week 12
timeFrame: 12 weeks
measure: Change in FPG From Baseline to 24 Weeks and Over Time
timeFrame: 24 weeks and over time
measure: Change in Proportion of Subjects With A1C Less Than or Equal to 7.0% at Week 24
timeFrame: 24 weeks
measure: Change in 30 Day Mean Glucose Comparing First Month to Last Month After 24 Weeks
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Baylor Endocrine Center, 3600 Gaston Avenue Wadley Tower, Suite 656, Dallas, TX 75246, Phone: 214-820-3466, Fax: 214-820-3468
name: Priscilla Hollander, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02943499: Mechanisms of Mindfulness for Smoking Cessation
Official title: Mechanisms of Mindfulness for Smoking Cessation: Optimizing Quantity and Quality.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Worcester
First posted: 2016-10-24
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
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 understand brain mechanisms of app-based mindfulness training in smokers ages 21 to 65 years.


Eligibility criteria: Inclusion Criteria:

* 21-65 years of age
* Smoke 10+ cigarettes/day
* \< 3 months abstinence in the past year
* Have a smartphone; and motivated to quit smoking
* Score \>18 of 20 on Action subscale of the Readiness to Change Questionnaire

Exclusion Criteria:

* Any usage of psychotropic medication: not on a stable dosage 6+ months
* Prior participation in a mindfulness course or regular meditation practice (\>20 min/week)
* Serious psychiatric, cognitive, or medical disorder
* MRI contraindications
* Structural brain damage as well as other brain abnormalities revealed by the MRI
* Claustrophobia
* Not being fluent in English
* Recreational drug use
* Pregnant women
* History of a neurological disorder
* Current participation in a smoking study
* Adults unable to consent
* Prisoners

Primary outcomes:
measure: Change From Baseline in Blood Oxygen Level Dependent (BOLD) Signal
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts, Worcester
state: Massachusetts
Study officials:
References:
Clinical trial NCT01631799: Outcome of Patients After Total Knee Replacement: A Comparison of Femoral Nerve Block and Epidural Anesthesia
Official title: Outcome of Patients After Total Knee Replacement: A Comparison of Femoral Nerve Block and Epidural Anesthesia. A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbidity
Mortality
Complications
Function
Keywords: epidural anesthesia
femoral block
patient control analgesia
Lead sponsor: University of Rostock
Sponsor class: OTHER
First posted: 2012-06-29
Enrollment: 80
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: Total knee replacement is very common in Germany. After surgery patients have severe pain in the knee; initiation of the physiotherapy, however, is important in the first three days after surgery. Continuous femoral blockade and continuous (lumbar) epidural analgesia are commonly used after surgery. Both methods are used in Germany. Both methods have advantages and disadvantages. We wanted to answer the question which method of analgesia - after total knee replacement - is better concerning complications and function (after 3 months) ?


Eligibility criteria: Inclusion Criteria:

* age 18 -80 years
* ASA I-III
* Surgery: total knee replacement
* informed consent

Exclusion Criteria:

* obesity
* contraindication for epidural anesthesia
* coagulation disorders

Primary outcomes:
measure: Function
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Mortality
timeFrame: 28 days after surgery
measure: Morbidity
timeFrame: 28 days after surgery
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: University of Rostock
state: Mecklenburg/Vorpommern
Study officials:
affiliation: Dep. of Anesthesia, University of Rostock
name: Thomas Mencke, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004699: Dose Ranging Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperinsulinism
Keywords: endocrine disorders
hyperinsulinism
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2000-02-25
Enrollment: 8
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Determine the dose of recombinant human insulin-like growth factor I that minimizes or decreases the need for exogenous glucose support without causing hypoglycemia.

Detailed description: PROTOCOL OUTLINE: This is a dose escalation study. Patients receive an escalating dose of recombinant human insulin-like growth factor I (IGF-I). IGF-I is given subcutaneously twice a day. The dose of IGF-I is increased each day for 4 days. Glucose is administered intravenously, when necessary, to prevent hypoglycemia.

Following the study treatment patients resume prior medication and may undergo surgery.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of hyperinsulinism (i.e., evidence of fasting hypoglycemia with inadequate suppression of insulin, normal pituitary and adrenal function, and increased insulin action)
* Intractable hypoglycemia (i.e., persistent IV glucose requirement for maintaining glucose levels greater than 60 mg/dL)
* Failed standard treatment regimen of diazoxide, octreotide, and frequent feedings to control hypoglycemia
* No other major medical problems

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Pinchas Cohen
role: STUDY_CHAIR
References:
Clinical trial NCT05191199: Studying the Incidence of Erectile Dysfunction in Patients Complaining of Congenital Penile Curvature
Official title: Incidence of Erectile Dysfunction in Patients Complaining of Congenital Penile Curvature
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: To Assess Erectile Function in Patients Complaining of Congenital Penile Curvature
Keywords: Congenital penile curvature, Erectile dysfunction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult males complaining of congenital penile curvature

Brief summary: Patients complaining of congenital penile curvature were subject to Penile duplex study to assess their curvature. Their penile duplex data including Peak Systolic velocity, End Diastolic velocity and Resistivity index were recorded as well as their assessing the degree of curvature and the quality of their erection using the erection hardness grading scale.


Eligibility criteria: Inclusion Criteria:

* Complaining of congenital curvature

Exclusion Criteria:

-

Primary outcomes:
measure: Penile duplex study parameters
timeFrame: 3 years
measure: Degree of curvature
timeFrame: 3 years
measure: Erection quality using the erection hardness grading scale
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Adham ZAAZAA, MD PhD MRCS FECSM
role: PRINCIPAL_INVESTIGATOR
References: