louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02803008: Sun Protection Factor Assay
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay (UVAPF), Minimal Persistent Pigment-Darkening Dose (MPPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-06-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun protection factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF(Self History Form)
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) Form
* An unbambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00707408: High-Dose Imatinib for Relapsed/Refractory c-Kit Positive Acute Myelogenous Leukemia (AML)
Official title: A Phase II Trial Evaluating the Safety and the Efficacy of High-Dose Imatinib in Relapsed/Refractory c-Kit Positive and BCR-Abl Negative AML Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: AML
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2008-06-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter open-label phase II trial of high dose imatinib mesylate in patients with AML in first or second relapse, or with refractory disease. Daily dosing of imatinib 600 mg/day is planned for one month or until progression of disease. Dose increase to 800 mg/ day imatinib is permitted for 2 additional months in the event of response failure. Response is assessed after 1, 2 and 3 months of treatment by bone marrow aspirate.

Detailed description: Daily dosing of imatinib 600 mg/day is planned for one month or until progression of disease. Dose increase to 800 mg/ day imatinib is permitted for 2 additional months in the event of response failure. Novartis provided supplies of imatinib for all patients included in the study.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years,
* AML in first or second relapse,
* refractory AML
* performance status of 0-2 on the Eastern Cooperative Oncology Group scale,
* adequate hepatic and renal functions (AST or ALT \<= 5 times the upper limit of normal
* creatinine \< 2 times the upper limit of normal)

  * 20% blasts in bone marrow,
  * 70% of bone marrow blast population c-kit positive as assessed by immunophenotyping
* Bcr-Abl negative chromosomal analysis (assessed by fluorescence in situ hybridization; FISH), and no chromosome 5-12 translocation

Exclusion Criteria:

* Previous treatment by Imatinib
* Secondary AML

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hopspital
Study officials:
References:
Clinical trial NCT05127408: Gastrointestinal Tract Disorders: A Prospective Multicenter Registry
Official title: Endoscopic Sutures for Gastrointestinal Tract Disorders: A Prospective Multicenter Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endoscopic Suturing
GI Tract Disorders
Gastrointestinal Disorders
Keywords: Sutures
gi
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient who has undergone clinically indicated and/or standard of care endoscopic suturing within the Gastrointestinal tract at Methodist Health System in Dallas.

Brief summary: The purpose of this prospective registry is to assess long-term data on efficacy, safety and clinical outcome of endoscopic placement of suture(s) and approximation of soft tissue within the gastrointestinal tract for various GI tract disorders. Currently, lack enough data evaluate and verify technical feasibility, clinical success and safety of endoscopic suturing in specific gastrointestinal disorders.1-16 Evaluation of these factors would help us compare them to conventional treatment modalities; and consequently help us identify appropriate treatment techniques and improve clinical management of patients.

Detailed description: This study is a prospective, observational, medical chart review for at least six standards of care visits up to 1 year after subject consents for study participation. There will be a retrospective chart review for patients who underwent endoscopic suturing procedures from October 2014 - April 2019. Those subjects will undergo no additional tests and procedures as part of this study. All data will be collected from patient's electronic health records (EHR) of the hospital In addition; a prospective chart review will be performed for patients who will undergo endoscopic suturing procedures from April 2019 to April 2021. All the subjects enrolled in prospective chart review will be first consented for their study participation. Subjects will undergo a clinically indicated endoscopic suturing procedure and standard of care follow up visits.

Eligibility criteria: Inclusion Criteria:

* Any patient who has undergone clinically indicated and/or standard of care endoscopic suturing within the Gastrointestinal tract
* Above or equal to 18 years of age

Exclusion Criteria:

* Any patient who has not undergone endoscopic suturing within the gastrointestinal tract
* Below 18 years of age

Primary outcomes:
measure: Documentation of successful procedures.
timeFrame: October 2014 to April 2021
Secondary outcomes:
measure: Documentation of unsuccessful procedures.
timeFrame: October 2014 to April 2021
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist Health System
name: Prashant Kedia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03304808: Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device: Star-Stop 3.0
Official title: A Randomized, Controlled Study of the Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Ejaculation
Cognitive-Behavior Treatment
Masturbation Aid Device
Keywords: premature ejaculation
cognitive-behavior
treatment
device
Lead sponsor: Instituto Sexológico Murciano
Sponsor class: OTHER
Collaborators: name: Universidad Miguel Hernandez de Elche
First posted: 2017-10-09
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study included 57 patients ≥18 years who met diagnostic criteria for PE including intravaginal ejaculatory latency time (IELT) of ≤2 minutes and had a Premature Ejaculation Diagnostic Tool (PEDT) score ≥11.

Subjects were randomized to an experimental group that used the device with exercise programme (n=18) a first control group that only used the exercise programme (n=17) and a wait-list control group (n=22).

As a main outcome measure used stopwatch-measured average IELT, Premature Ejaculation Profile (PEP), and the Golombok-Rust Inventory of Sexual Satisfaction (GRISS).


Eligibility criteria: Inclusion Criteria:

* Participants must be heterosexual males
* To be in a stable monogamous, sexual relationship with a female partner for at least 6 months,
* Must score = 11 in the Premature Ejaculation Diagnostic Tool (PEDT).
* Must have a self-estimated average intravaginal ejaculatory latency time (IELT) of \<2 min. -Must be in good general health with no clinically significant abnormalities as determined by medical history and clinical lab results.

Exclusion Criteria:

* To suffer an alteration or mental disorder according to the criteria of the DSM-IV.
* History of alcohol abuse and dependence.
* Do not to consume medication, drugs of recreative use or alcohol (except for caffeine or nicotine/tobacco).

Primary outcomes:
measure: IELT FOLD INCREASE
timeFrame: 7 weeks
Secondary outcomes:
measure: Premature Ejaculation Profile (PEP)
timeFrame: 7 weeks
Other outcomes:
measure: Golombok Rust Inventory of Sexual Satisfaction (GRISS)
timeFrame: 7 weeks
Locations:
city: Murcia
country: Spain
facility: Jesús Rodríguez
Study officials:
References:
Clinical trial NCT01588808: Immobilization and Protein Supplementation (IM-PRO)
Official title: The Impact of Dietary Protein Supplementation and Age on Muscle Mass Loss During Short Term One-legged Knee Immobilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disuse Atrophy
Aging
Keywords: Immobilization
Protein supplementation
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2012-05-01
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In the present study, the effects of 5 days of lower limb immobilization with or without twice-daily protein supplementation on muscle mass and muscle fiber characteristics will be determined. A young group will be included to compare the changes in muscle mass and muscle fiber characteristics between young and old men.


Eligibility criteria: Inclusion Criteria:

* Male
* Aged from 18-35 years and from 65-75 years
* 18.5 \< BMI \< 30 kg/m2

Exclusion Criteria:

* Smoking
* Performing regular resistance training in the previous 6 months
* Hypertension (according to WHO criteria) \[52\] and/or cardiovascular disease
* Any back/leg/knee/shoulder complaints which may interfere with the use of crutches
* Systemic use of antibiotics within 3 weeks prior to the study visit
* Current systemic use of corticosteroids, growth hormone, testosterone, immunosuppressants or insulin
* Type 2 diabetes mellitus
* Any history of thrombosis
* Any family history (1st grade) of thrombosis
* All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis).
* Myocardial infarction within the last 3 years
* Use of anti-coagulants
* Any (history of) gastrointestinal disease that interferes with GI function
* Indications related to interaction with the study product:
* Known allergy to milk or milk products
* Known galactosemia

Primary outcomes:
measure: Change in muscle mass
timeFrame: three days before immobilization, and directly after immobilization (day of cast removal; day 6)
measure: Change in muscle fiber size
timeFrame: three days before immobilization, and directly after immobilization (day of cast removal; day 6)
Secondary outcomes:
measure: Change in muscle strength measured by quadriceps 1-Repetition Maximum by Leg Extension
timeFrame: Three days before immobilization, and directly after immobilization (day of cast removal; day 6)
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
Study officials:
affiliation: Maastricht UMC
name: Luc JC van Loon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dirks ML, Wall BT, Nilwik R, Weerts DH, Verdijk LB, van Loon LJ. Skeletal muscle disuse atrophy is not attenuated by dietary protein supplementation in healthy older men. J Nutr. 2014 Aug;144(8):1196-203. doi: 10.3945/jn.114.194217. Epub 2014 Jun 11.
Clinical trial NCT05740423: Standardization of Anti-Seizure Medications Withdrawals After Seizure Remission in Young Patients With Epilepsy
Official title: Anti-Seizure Medications Withdrawals After 2 Years of Seizure Remission
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Epilepsy in Children
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Republic of Korea
name: Korea Health Industry Development Institute
First posted: 2023-02-23
Enrollment: 1200
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Epilepsy or acute provoked seizure according to the ILAE guideline

Brief summary: The proper period of anti-seizure medication (ASM) treamtment is important for decreasing side effect of ASM and recurrence of seizure. We evaluate reliable risk factor analysis for safe withdrawal of ASM in children with epilepsy. Futhermore, we develop the scoring system for prediction of seizure recurrence to set the standard for safe withdrawal of ASM.

Detailed description: The proper period of anti-seizure medication (ASM) treamtment is important for decreasing side effect of ASM and recurrence of seizure. We evaluate reliable risk factor analysis for safe withdrawal of ASM in children with epilepsy. Futhermore, we develop the scoring system for prediction of seizure recurrence to set the standard for safe withdrawal of ASM.

The enroll criteria as follow:

1. patients with epilepsy or acute provoked seizure accroding to the ILAE definition
2. patients who have been 2 years of seizure free with or without ASM

The patients with seizure recurrence during follow-up or end of follow-up period of 24 months will end this stutdy.

Eligibility criteria: Inclusion Criteria:

* Patients with Epilepsy or acute provoked seizure according to the ILAE guideline
* Patients with 2 years of seizure free periods

Exclusion Criteria:

* Uncertain diagnosis of epilepsy or acute provoked seizure
* Patients who do not want to participate in the study

Primary outcomes:
measure: Patients umber of seizure recurrence
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Min-Sun Yum
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00136123: Immediate Load of Dental Implants, Placed in Atrophic Upper and/or Lower Jaw of Partial or Complete Edentate Patients, According to Flapless Technique
Official title: Immediate Load of Dental Implants, Placed in Atrophic Upper and/or Lower Jaw of Partial or Complete Edentate Patients, According to Flapless Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Nobel Biocare
First posted: 2005-08-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the placement of implants with minimal invasive techniques. Immediately after the placement of the implants, functional loaded synthetic teeth will be placed.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older

Primary outcomes:
measure: Implant success at 0-3 years
timeFrame: At 0-3 years
Secondary outcomes:
measure: Prosthetic success
timeFrame: At the moment
measure: Patient opinion
timeFrame: At same day
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Hugo De Bruyn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02996123: Biting Force in Heat Cured Acrylic Resin Versus CAD/CAM Maxillary Single Denture Bases
Official title: Biting Force in Heat Cured Acrylic Resin Versus CAD/CAM Maxillary Single Denture Bases: A Randomized Controlled Trial .
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bites, Human
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 63
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: measuring difference in biting force between (computer aided design/computer aided manufacturing) maxillary dentures and conventional ones.

Detailed description: measuring difference in biting force using i-load device with followup period of 6 months

Eligibility criteria: Inclusion Criteria:

1. Patients with completely edentulous maxillary ridge with minimum undercuts, opposing a partially edentulous ridge.
2. Mean age of 50-75 years of age.
3. The edentulous ridges should be covered by firm healthy mucosa.
4. Systemically free; no history of diabetes, chemotherapy, and radiotherapy.
5. Co-operative patients.

Exclusion Criteria:

1. Patients with severely resorbed maxillary ridge
2. Previous history of radiotherapy or chemotherapy.
3. Patients with xerostomia
4. Patients with neuromuscular and hormonal disorders
5. Patients with severe bony or soft tissue undercuts
6. Patients with large tongue
7. Patients with limited mouth opening
8. Patients with known history of allergy, especially to acrylic resin

Primary outcomes:
measure: Biting Force in Heat Cured acrylic resin versus CAD/CAM Maxillary Single Denture Bases
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo Governorate
country: Egypt
facility: Cairo university
Study officials:
References:
Clinical trial NCT01050608: Evaluation of Body-worn Multimodal Hand Hygiene System. Impact on Health-Care Associated Infections
Official title: Real Time Deployment of Multimodal Personal Dispenser Hand Hygiene System in a Multidisciplinary Intensive Care Unit.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nosocomial Infection
Keywords: Alcohol Rub
Hand Hygiene
Provider Feedback
Health Care Associated Infections
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Harbor Medical Inc.
First posted: 2010-01-15
Enrollment: 2954
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive Care Unit Patients Multidisciplinary Intensive Care Unit

Brief summary: Evaluate the efficacy of a multimodal hand hygiene system in the intensive care unit environment and evaluate any impact on health care associated infections.

Detailed description: Deploy and utilize a novel body worn hand hygiene system that incorporates provider and group specific feedback allowing hand hygiene to occur directly within the patient environment. We hypothesize that by improving provider hand hygiene we will reduce health-care associated infection rates.

Eligibility criteria: Inclusion Criteria:

* All ICU patients

Exclusion Criteria:

* Patient is not in an ICU at our Institution

Primary outcomes:
measure: Reduction in healthcare associated infections (CRBSI and VAP)
timeFrame: 2 years
Secondary outcomes:
measure: Time to infections Hospital mortality Length of stay
timeFrame: 2 years
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-HItchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Matthew D. Koff, M.D. M.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth-Hitchcock Medical Center
name: Randy L Loftus, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anesthesiology 2008; 109 A54 ASA Abstracts
Clinical trial NCT00310908: Comparison Between Tramadol Hcl and Other Analgesics in the Treatment of Renal Colic
Official title: Efficacy of Tramadol Hcl in the Treatment of Renal Colic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Calculus
Keywords: Renal
Colic
Calculi
Treatment
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Grumental
First posted: 2006-04-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Tramadol Hcl is as effective as Voltaren a non-steroidal antiinflammatory drug, and Dipyrone in amelioration of the pain caused by acute renal colic.

Detailed description: Renal stones is a common condition affecting up to 1% of the american population. The main symptom is renal colic. Acute treatment is based on the administration of analgesics mainly those belonging to non-steroidal antiinflammatory drugs (NSAIDs). Tramadol is an analgesic of the opioid class of analgesics (i.e morphine) and it is considered to cause less side effects with more or less the same analgesic potency. In the present study the analgesic effect of intramuscular Tramadol will be compared with Voltaren (NSAID)in patients attending the Emergency Department (ED) for acute renal colic (Stage I). Most of these patients will not pass their stone during their visit to the ED and they are prone to develop another attack of renal colic.In the second phase of the study (Stage II)patients who improved, and are ready to go home, will be enrolled to get Dipyrone or Tramadol orally for the prevention of further pain.

Eligibility criteria: Inclusion Criteria:

* Patients with clinical diagnosis of acute renal colic (Stage I)
* Patients with diagnosed renal colic who might need prevention of pain and are able to swallow medicines (Stage II)

Exclusion Criteria:

* Patients with known hypersensitivity to the study drugs
* Pregnancy or lactation
* Known renal failure or hepatic disease
* Concommitant drug use which could adversely affect patient's outcome (oral anticoagulant, MAO inhibitors)

Primary outcomes:
measure: Pain improvement according to VAS score at 30, 60 and 120 minutes(Stage I)
timeFrame: 30, 60, 120 minutes
measure: Need for rescue medication at 30 minutes (Stage I)
timeFrame: 30 minutes
measure: Pain improvement according to VAS score at 24 and 48 hrs (Stage II)
timeFrame: 24 and 48 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Ruth Stalnikowicz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ukhal' MI, Melenevskii DA. [Using prostaglandin inhibitor dicloberl in patients with ureteral calculi]. Lik Sprava. 2004 Mar;(2):76-8. Russian.