louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00680095: Cumulative Irritation Test
Official title: 21-day Cumulative Irritation Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Onychomycosis
Keywords: Onychomycosis
Fungal Nail
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-05-19
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.

Detailed description: Healthy, adult volunteers of either sex will be patched on his/her back with AN2690 Solution 2.5%, AN2690 Solution 5%, AN2690 Solution 7.5%, AN2690 Solution Vehicle and Sodium Laurel Sulfate 0.5% over the course of 21 consecutive days. After 24 hours, the patches are to be removed and the site evaluated using a five-point scale for irritation.

Eligibility criteria: Inclusion Criteria:

* Healthy, volunteers of either sex, at least 18 years of age or older
* Females of childbearing potential submitted to a urine pregnancy test and had negative results at Day 1 and at the final visit and also was using an effective method of birth control (e.g. abstinence, implants, injectables, oral contraceptives, intrauterine contraceptive devices or double barrier) or agreed to use an effective method of birth control prior to becoming sexual active
* Subjects were of any skin type or race providing their degree of pigmentation did not interfere with making readings of skin reactions
* Subjects were willing to follow the study procedures and complete the study
* Written informed consent was obtained

Exclusion Criteria:

* Subject with any skin disease that would have in any way confounded interpretation of the study results. Atopic dermatitis/eczema, psoriasis or chronic asthma were excluded
* Subject was pregnant or nursing
* Subject had a history of sensitivity to any component of any of the formulations
* Use of chronic medications (such as antihistamines, corticosteroids, analgesics and anti-inflammatories) for one week before and during the study

Primary outcomes:
measure: Severe irritation (Grade 3 or 4) observed at any site
timeFrame: Daily for 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lynchburg
country: United States
facility: The Education and Research Foundation, Inc.
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00550095: To Assess the Effects of Valsartan on Albuminuria/Proteinuria in Hypertensive Patients With Type 2 Diabetes Mellitus
Official title: A 24 Week, Multi-centre, Open Label, Non Controlled Study to Assess the Efficacy of Valsartan in Reducing Albuminuria/Proteinuria in Hypertensive Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Microalbuminuria
Proteinuria
Keywords: Microalbuminuria/proteinuria
hypertensive patients with type 2 diabetes
Valsartan
microalbuminuria/proteinuria in hypertensive patients with type 2 diabetes
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-10-26
Enrollment: 509
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to assess the efficacy of the different dosage forms of Valsartan\[80, 160, and 320 mg\] in reducing microalbuminuria/proteinuria in hypertensive patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Males or females aged 35 to 75.
* Type 2 diabetes mellitus (DM) patients coupled with hypertension \[sitting systolic blood pressure (SSBP) 140-179 mm Hg and/or SDBP 90-109 mm Hg\].
* Urinary albumin creatinine Ratio (UACR)) indicating microalbuminuria/proteinuria \[30-1000 mg/g or 2.5-25 mg/mmol\]
* Body mass index (BMI) \<40 kg/m2
* Patients who will sign an informed consent.

Exclusion Criteria

* Type 1 DM
* All causes of secondary diabetes mellitus
* Women of childbearing potential who refuse to use contraception.
* Pregnant or lactating females.
* Severe hypertension \[SSBP\> 180 mmHg, sitting diastolic blood pressure (SDBP) \> 110 mmHg \]
* Patients who are on combo therapy to control BP
* Patients who are already on Valsartan.
* Hypersensitivity to Valsartan.
* Renal artery stenosis \[ unilateral or bilateral\]
* Patients taking β blockers, (Angiotensin Converting Enzyme Inhibitor (ACEI) or spironolactone
* Heart Failure
* History of myocardial infarction, Percutaneous Transluminal Coronary Angioplasty(PTCA) or cerebrovascular accident within the preceding 3 months.
* Creatinine levels \> 1.4 mg/dl \[ 0.07mmol/l\]. Liver enzymes \> 2 times Upper Limit of the Normal Range(ULN). Diabetic keto-acidosis (DKA) within the last 6 months. Presence of diabetic neuropathy or retinopathy. Diabetic foot complications. Presence of infection at time of screening. Hyperkalemia (serum K+ \> 5.5 mmol/L)

Primary outcomes:
measure: Change in Albumin Creatinine Ratio (ACR) from baseline over a period of 24 weeks.
timeFrame: Week 24
Secondary outcomes:
measure: Percent reduction of (BP) at 24 weeks compared to baseline level. Percent of patients whose BP is controlled at 24 weeks (< 130/80)
timeFrame: Week 24
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Novartis Investigative Site ,
Study officials:
affiliation: Sponsor GmbH
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
Clinical trial NCT04851795: Effectiveness of a Supervised Hospital-based Physical Exercise
Official title: Effectiveness of a Supervised Hospital-based Physical Exercise Intervention to Reduce Stress in Health Care Professionals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress, Psychological
Anxiety
Lead sponsor: Bioaraba Health Research Institute
Sponsor class: NETWORK
First posted: 2021-04-20
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess if physical activity is effective in reducing stress and anxiety in healthcare professionals.

Detailed description: To assess if physical activity is effective in reducing stress and anxiety in healthcare professionals.

To evaluate if physical activity is effective in improving the physical and mental state of health care professionals and improving several blood parameters (lipid profile and blood glucose).

Eligibility criteria: Inclusion criteria

* Apt for sports practice after review by the corresponding health professional of the Occupational Health Service,
* Motivation for sports practice (could be self-referred or on an EVA scale from a score for example of 6) being 0 not motivated at all and 10 totally motivated.

One could extrapolate the score limits of the EVA scale pain no motivation=0; mild motivation=1,2; moderate=3-5; high from 6.

* Professionals whose working day does not coincide with the hours during which the sessions are to be given.
* Professionals who do not work shifts.

Exclusion Criteria:

* Any type of contraindication for sports practice (Annex I),
* Staff who, due to their activity, have greater mobility in the hospital (orderlies).
* Osteoarticular injuries, cervical and lumbalgias.

Withdrawal criteria

-Within the intervention group - absence maximum two weeks to the exercises. This will not be taken into account during the summer period.

Primary outcomes:
measure: Perceived Stress
timeFrame: at six months
Secondary outcomes:
measure: Goldberg anxiety questionnaire
timeFrame: at six months
measure: Short Form Survey_Mental health
timeFrame: at six months
measure: Short Form Survey_Physical condition
timeFrame: at six months
measure: Ruffier index
timeFrame: at six months
measure: Weight
timeFrame: at six months
measure: Body mass index
timeFrame: at six months
measure: lipid profile
timeFrame: at six months
measure: glycosylated hemoglobin
timeFrame: at six months
measure: work absenteeism
timeFrame: at six months
Other outcomes:
Locations:
city: Vitoria-gasteiz
country: Spain
facility: Araba university hospital
state: Alava
city: Vitoria-gasteiz
country: Spain
facility: Bioaraba Health Research Institute
state: Alava
Study officials:
References:
Clinical trial NCT04364295: Stronger Together Global Registry
Official title: Evaluating Real-World Spine Outcomes for Spinal and Orthobiologics Products From Around the World
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Spinal Disease
Lead sponsor: SeaSpine, Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-28
Enrollment: 2285
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 2285 patients who were previously implanted with SeaSpine products

Brief summary: A global, prospective, non-randomized, multicenter, observational, post-market, medical record review registry evaluating real-world evidence for SeaSpine products.

Detailed description: To gain observational, prospective, real-world clinical, and radiographic data in order to evaluate continued safety and performance following the implantation of SeaSpine products.

Eligibility criteria: Inclusion Criteria:

* Have been treated with at least one SeaSpine product.
* Have obtained radiographic imaging, as part of the standard of care, at the following time points: preoperative and postoperative.
* Have obtained at least one preoperative patient-reported outcome measure, as part of the standard of care.
* Patient is planned, per standard of care, to be assessed with radiographic imaging and consistent patient-reported outcome measure(s) from preoperative through at least two scheduled follow-up visits.

Exclusion Criteria:

* Was not implanted with at least one SeaSpine product during operation
* Any other condition that the Investigator determines is unacceptable for enrollment into this registry

Primary outcomes:
measure: Evaluation of product failure
timeFrame: 12 months post-operative
Secondary outcomes:
measure: Incidence of product-related Serious Adverse Events (SAEs) related to the spine, fusion or bone healing, and intraoperative and postoperative unanticipated adverse device effects
timeFrame: Intra-operative to 24 months
Other outcomes:
Locations:
city: Durango
country: United States
facility: Spine Colorado
state: Colorado
city: New Albany
country: United States
facility: OrthoNeuro
state: Ohio
Study officials:
affiliation: SeaSpine Orthopedics Corporation
name: Frank Vizesi, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04153695: Flamenco Music Therapy in Pregnant
Official title: Therapeutic Flamenco Musical Intervention in Pregnant Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Music
Therapy
Keywords: Pregnant
Anxiety
Depression.
Flamenco music
Lead sponsor: Telethusa Centre for Flamenco Research
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The use of music as a therapy for the psychological and emotional improvement of pregnant women has been well studied. Our hypothesis is that flamenco music can also involve psycho-emotional improvements in pregnant women

Detailed description: The objective of the study is to analyze the effects of a flamenco musical intervention on the stress and anxiety of pregnant women in five Management Units of the Sanitary District in Bahía de Cádiz-La Janda (Spain).

50 pregnant women will voluntarily participate in this study (25 in a control group and 25 in the experimental group) The psychological health assessment will be measured through the Perceived Stress Scale (PSS), the State-Trait Anxiety Inventory (S-STAI) and the Edinburgh Postnatal Depression Scale (EDPS) pre and post exposure.

Eligibility criteria: Inclusion Criteria:

* Volunteer
* Single pregnancy
* Uncomplicated pregnancy,
* Expectations of vaginal delivery without complications
* Gestational age between 18 and 33 weeks,

Exclusion Criteria:

* Visual disorders
* Hearing disorcers
* Mental or cognitive disorders
* Difficulties in pregnancy,
* Medical complications,
* Smoker during the gestation period

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: 4 months
measure: State-Trait Anxiety Inventory
timeFrame: 4 months
measure: Edinburgh Postnatal Depression Scale
timeFrame: 4 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Cádiz
country: Spain
facility: Alfonso Vargas-Macías
Study officials:
affiliation: Telesthusa Centre for Flamenco Research
name: Alfonso Vargas-Macías, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02776995: Tumor Monitoring Using Thermography During Radiation Therapy
Official title: Tumor Monitoring Using Thermography During Radiation Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malignancy
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Tel Aviv University
First posted: 2016-05-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This research aims to investigate the correlation between tumor temperature difference and biological factors, such as size, metabolism, treatment response, and tumor aggressiveness.

In addition, normal tissue response to adjuvant radiation therapy in treated organs following surgery, will be evaluated.

Detailed description: During radiation session, the investigators would evaluate the changes that will be detected by thermal imaging and correlate them with visible side effects as well as with known tumor biology factors and skin-tumor distance.

Eligibility criteria: Inclusion Criteria:

* signed informed consent
* will undergo radiation therapy for palliation or curative intent due to cancer, biopsy proven

Exclusion Criteria:

* not eligible to sign informed consent

Primary outcomes:
measure: Measurement of IR : Infra-Red radiation emitted at wavelengths 0.8-1nm
timeFrame: Before the first fraction of radiation and every 5 fraction until the end of radiation therapy, approximately 4-5 weeks.
Secondary outcomes:
measure: Dermal side effects during radiation therapy using CTCAE v4.0
timeFrame: Before the first fraction of radiation and every 5 fraction until the end of radiation therapy, approximately 4-5 weeks.
measure: US/CT scans
timeFrame: The tumor size in cubic cm will be mesured prior to first fraction of radiation, and 2 weeks following the end of radiation session. Time for final evaluation: approximately 6-7 weeks.
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Merav Ben David
Study officials:
affiliation: Sheba Medical Center
name: Merav Ben-David, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01458795: The Fate Of Calf Perforators After Endovenous Laser Ablation Of Saphenous Veins
Official title: The Fate Of Calf Perforators After Endovenous Laser Ablation Of Saphenous Veins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Venous Insufficiency
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2011-10-25
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the morphologic and hemodynamic changes in the calf perforators after endovenous laser ablation of saphenous veins.


Eligibility criteria: Inclusion Criteria:

* Symptomatic patients who undergo EVLA procedure for saphenous vein insufficiency

Exclusion Criteria:

* Patients with a history of deep venous thrombosis (DVT)
* Previous varicose vein surgery or injection sclerotherapy
* Patients without superficial venous incompetency

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Baskent University
Study officials:
References:
Clinical trial NCT03380195: Effects of Watermelon Juice on Heart Rate Recovery and Post-exercise Muscle Soreness
Official title: Effects of Watermelon Juice on Heart Rate Recovery and Post-exercise Muscle Soreness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Rate Recovery
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to determine the effects of a pre-exercise, single practical dose of watermelon juice, Gatorade, sugar water or water on heart rate recovery, blood lactate levels, and 24-hour post exercise muscle soreness.


Eligibility criteria: Inclusion Criteria:

* ages of 21-50 healthy adults

Exclusion Criteria:

* Suffering from injury
* Chronic inflammatory conditions
* Required dietary supplement use
* Required medication which affects blood pressure
* Smoking
* Pregnant woman
* Allergy to watermelon

Primary outcomes:
measure: Change of heart rate after submax exercise
timeFrame: Baseline and every minute post exercise for a maximum 20 minutes post exercise.
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Exercise and Nutritional Sciences, SDSU
state: California
Study officials:
References:
Clinical trial NCT02402595: Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts
Official title: A Phase 1, Single-center, Randomized, Double-blind, Double-dummy, Drug Interaction Study Between AVP-923 and Itraconazole, and Between AVP-786 and Itraconazole in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Drug-drug interaction
Healthy Volunteers
Pharmacokinetics
deuterated dextromethorphan
dextromethorphan
dextromethorphan with quinidine
deuterated dextromethorphan with quinidine
itraconazole
Lead sponsor: Avanir Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-03-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the effects of a potent CYP3A4 inhibitor, itraconazole, on the steady-state PK of AVP-923 and AVP-786.

Detailed description: A Phase 1, single-center, randomized, double-blind, double-dummy drug interaction study.

Eligibility criteria: Inclusion Criteria:

* Healthy adult males and females, 18 to 55 years of age
* Body Mass Index (BMI) ≥19 and ≤30 kg/m2 (for both males and females)

Exclusion Criteria:

* History or presence of significant disease
* History of substance abuse or dependence (except caffeine), or treatment for substance use disorder(s) within the year prior to screening or within 6 months for nicotine including e-cigarettes
* Use of any tobacco-containing or nicotine-containing products within 6 months prior to the first dose
* Use of any prescription or the over-the-counter medications within 14 days

Primary outcomes:
measure: Change in plasma concentration of AVP-923 after dosing in combination with itraconazole
timeFrame: 16 Days
measure: Change in plasma concentration of AVP-786 after dosing in combination with itraconazole
timeFrame: 16 Days
Secondary outcomes:
measure: Incidence of adverse events (AEs) for AVP-923 and itraconazole
timeFrame: 16 Days
measure: Incidence of adverse events (AEs) for AVP-786 and itraconazole
timeFrame: 16 Days
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research, Inc.
state: Kansas
Study officials:
affiliation: Vince and Associates Clinical Research Inc.
name: Martin Kankam, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05193695: How to Reduce Dry Needling Pain in Treatment of Trigger Points of Muscle Triceps Sural in Ankle Post Fracture Patients
Official title: Heat or Excesice in Treadmill as Techique to Reduce Dry Needling Pain in Treatment of Trigger Points of Muscle Triceps Sural in Ankle Post Fracture Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Physical Therapy Modalities
Pain Measurement
Trigger Point Pain, Myofascial
Ankle Fractures
Rehabilitation
Needles
Keywords: Humans
Excercise therapy
Hot temperature
Post dry needling
Range of motion, articular
Muscle Strength
Lead sponsor: Becerra, Pablo
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ankle fractures are one of the main causes of hospitalization due to injuries in Chile, which also have a discharge and partial load time of approximately 12 weeks in the recovery process. This generates disuse and atrophy of the posterior musculature of the leg called the triceps sural, which makes it difficult to restart and perform the gait. We conducted this research because practically all patients with this type of diagnosis have trigger points in these muscles, and dry needling technique is one of the best for its treatment, but has the disadvantage that it produces post dry needling pain of 48 hours and there is not enough information, or consensus on which method is better to reduce post dry needling pain. This study aims to prove wich technique is most useful in reducing pain post dry needling for the treatment of trigger points in the triceps sural muscle in ankle post fracture patients.


Eligibility criteria: Inclusion Criteria:

* Ages between 18 and 60 years of age.
* Man or woman.
* At least one trigger point, active or latent, in the triceps sural muscle of the fractured ankle.
* Perform full load without using technical aids.

Exclusion Criteria:

* Use of analgesics.
* Insurmountable fear of needles.
* Immune disease.
* Clotting disorders.
* Sensory disorders.
* Psychiatric / psychological illness.
* Cancer.
* Rheumatic diseases.

Primary outcomes:
measure: Perceived pain intensity
timeFrame: Change from baseline (baseline and immediately after treatment)
measure: Ankle Range of Motion (ROM)
timeFrame: Change from baseline (baseline and immediately after treatment)
Secondary outcomes:
measure: Muscular strength of triceps sural
timeFrame: Change from baseline (baseline and immediately after treatment)
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Complejo Hospitalario San Jose
Study officials:
References: