louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01097850: Topical Henna Preparation for the Treatment of Hand Foot Skin Syndrome
Official title: Prospective Randomized Controlled Open-label Trial of a Topical Henna Preparation for the Treatment of Hand-Foot Skin Syndrome and Its Associated Symptoms
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hand Foot Skin Syndrome
Keywords: hand foot skin syndrome
palmar plantar erythrodysesthesia
doxorubicin
capecitabine
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2010-04-02
Enrollment: 0
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: The purpose of this study is to determine whether henna paste is effective in the treatment of hand-foot skin syndrome, induced by the drugs Capecitabine and pegylated liposomal doxorubicin.


Eligibility criteria: Inclusion Criteria:

* Patients receiving capecitabine and/or pegylated liposomal doxorubicin as monotherapy or in combination with other agents
* New diagnosis of active hand-foot skin reaction (on bilateral hands and/or bilateral feet) of 1-3 toxicity as defined by the NCI-CTCAE version 4.0 grading scale with onset of symptoms within the last thirty days
* Patients must be 18 years or older
* Patients must provide written informed consent to participate in the study

Exclusion Criteria:

* Patients with pre-existing dermatological condition affecting the hands or feet that may limit the interpretation of results
* Known allergy to natural henna
* Patients with a previous history of HFS
* History of G6PD deficiency as determined by screening bloodwork

Primary outcomes:
measure: • To compare the severity of HFS in subjects receiving topical natural henna paste treatment along with using CeraVe™ moisturizing cream concurrently on the treatment side and using only CeraVe™ moisturizing cream on the control side.
timeFrame: 3 weeks
Secondary outcomes:
measure: To examine quality of life, comparing natural henna treatment versus CeraVe™ alone, using the Skindex-16 questionnaire
timeFrame: 3 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Peter Lio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01262950: Development of a Fall Prevention and Fall Detection System for Ambulatory Rehabilitation of Parkinson's Patients
Study type: EXPANDED_ACCESS
Overall status: TEMPORARILY_NOT_AVAILABLE
Conditions: Parkinson's Disease
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2010-12-20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The investigators plan to conduct a first-stage experiment by recruiting ten subjects, including five PD patients and five non-PD patients. In the beginning, the information collected by the portable motion detector is used to compare the difference in the activities performed by PD and non-PD patients. Besides, the algorithm will be developed to identify the gait patterns of PD patients. Once the system detects the abnormal gaits, such as shuffling and festinating steps or freezing of gait, auditory cues will be given to the PD patients and caregivers by their sides. It can help the patient to maintain normal gait and improve the effectiveness of rehabilitation, as well as preventing falls in daily activities. Moreover, in case of accident falls, the real-time fall detection mechanism alerts the nearest caregiver for instant support and delivers this information to the remote family members and medical personnel.

After that, a second-stage experiment will be carried out by recruiting another five PD patients. By comparing the gait patterns identified by the system against those identified manually by the staff, the performance of the proposed system on fall prevention will be examined. For the patients and their family members, the developed system enhances the patients' safety in their daily activities. As for the medical personnel, it serves as an affordable tool that benefits the rehabilitation of PD patients in an easy manner.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Parkinson's Disease

Exclusion Criteria:

* Cardiac disease
* Mobility disability

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01145950: Study to Compare the Safety and Pharmacokinetic Characteristics of LBEC0101 25 mg With Those of Enbrel®
Official title: A Randomized, Double-blind, Single-dosing, 2-way Cross-over Study to Compare the Safety and Pharmacokinetic Characteristics of LBEC0101 25 mg With Those of Enbrel® Injection 25 mg After Subcutaneous Injection in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Etanercept
Enbrel
healthy volunteers
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2010-06-17
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To compare the pharmacokinetic characteristic of LBEC0101 25mg with the active comparator, Enbrel® 25 mg.


Eligibility criteria: Inclusion Criteria:

* Healthy males, 20 to 45 years of age the moment of screening
* Body mass index is between 18.0 and 30.0 kg/m

Exclusion Criteria:

* The tuberculosis patient or latent tuberculosis patient
* Hypersensitivity response to the test and comparator drugs

Primary outcomes:
measure: Etanercept levels in blood
timeFrame: 22 day
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University College of Medicine and Hospital
name: Kyung-Sang Yu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01893450: Bromocriptine and Pentoxifylline in Ophthalmopathy Autoimmune Treatment
Official title: Comparison of the Effect of Bromocriptine and Pentoxifylline in Mild to Moderate Autoimmune Ophthalmopathy. A Randomized, Controlled, Single Blind, Clinical Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Graves Ophthalmopathy
Keywords: Graves ophthalmopathy
Exophthalmos
Proptosis
Quality of life
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2013-07-09
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Autoimmune ophthalmopathy is clinically evident in one third of Graves' disease cases. In most cases it is mild; however, in 3 to 5% of cases it has a severe presentation. At present, the treatment is directed to identify vision threatening which requires aggressive intervention, usually with glucocorticoids. For mild cases the treatment is limited to the normalization of hyperthyroidism and support measures. Preliminary data show that pentoxifylline and bromocriptine may have a favorable effect in the course of ophthalmopathy by inhibition of the synthesis of TNF-α, VEGF, glycosaminoglycan production, and lymphocyte infiltration. Therefore, the aims of this study were to evaluate the effect of bromocriptine and pentoxifylline on the clinical course and quality of life of patients with mild to moderate ophthalmopathy associated to Graves´disease.

Methods. Patients with mild to moderate ophthalmopathy, with less than one year of evolution, and naive to treatment were randomized to receive treatment during 12 months with either 1) bromocriptine (5 mg twice a day) + methimazole (30 mg/day), 2) pentoxifylline (400 mg twice a day) + methimazole (30 mg/day), or 3) methimazole only (30 mg/day). They completed 10 visits to evaluate proptosis and clinical activity score (CAS). In addition, in the first and last visit the quality of life questionnaire specific for Graves' ophthalmopathy(GO-QOL) was applied.


Eligibility criteria: Inclusion Criteria:

* Women or men
* Between 18 and 45 years
* Autoimmune hyperthyroidism with one year or less of evolution
* No previous treatment
* Mild to moderate ophthalmopathy

Exclusion Criteria:

* Smoking
* Severe ophthalmopathy
* Steroid treatment
* Asthma
* Diabetes or other significant disease
* Creatine \>1.5 mg/dl
* Women with child bearing potential not using a birth control method
* Opthalmologic diseases
* Uncontrolled hypertension
* History of ischemic cardiopathy
* History of stroke
* History of gastrointestinal bleeding

Primary outcomes:
measure: Proptosis
timeFrame: One year
Secondary outcomes:
measure: Clinical activity score
timeFrame: One year
measure: Quality of life
timeFrame: One year
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
state: Distrito Federal
Study officials:
References:
Clinical trial NCT03147950: Prone Versus Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)
Official title: Prone Versus Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL) Comparing Efficacy and Complication According to Clavien-Dindo Classification Score Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Percutaneous Nephrolithotomy (PCNL)
Prone Position
Prone-Flexed Position
Complication of Surgical Procedure
Keywords: Prone-Flexed Position
Percutaneous Nephrolithotomy (PCNL)
Clavien-Dindo Classification Score
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 100
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: compare the prone with the prone-flexed position accessibility of upper and middle calyceal approach by subcostal puncture and PCNL reporting complications using the Clavien-Dindo system with Categorisation of PCNL-specific complications according to Clavien-Dindo classification score


Eligibility criteria: Inclusion Criteria:

* Large renal pelvic stone
* Upper calyceal stone
* Middle calyceal stone

Exclusion Criteria:

* lower calyceal stone
* Bilateral simultaneous PCNL
* Need for 3 percutaneous tracts intraoperative
* Morbid obesity (BMI \>40)
* Non opaque renal stones.
* Refuse to complete study requirements

Primary outcomes:
measure: Comparing the prone with the prone-flexed position for PCNL reporting complications
timeFrame: 1 year
Secondary outcomes:
measure: Assessment of stone free rate (SFR) of the two groups
timeFrame: 1 year
measure: Asses the easiness of accessibility of the targeted stone
timeFrame: 1 year
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center
state: Aldakahlia
Study officials:
affiliation: Urology and Nephrology center
name: Ahmed Shoma, MD
role: STUDY_CHAIR
affiliation: Urology and Nephrology center
name: Ahmed Elassmy, MD
role: STUDY_DIRECTOR
affiliation: Urology and Nephrology center
name: Nasr Eltabey, MD
role: STUDY_DIRECTOR
affiliation: Urology and Nephrology center
name: Mohamed Zahran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Urology and Nephrology center
name: Mahmoud Laimon, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Urology and Nephrology center
name: Hossam Nabeeh, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Urology and Nephrology center
name: Mohamed Abdulatif, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02373150: Safety, Tolerability and PK of Imeglimin in Japanese Volunteers
Official title: A Phase 1, Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Imeglimin in Healthy Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Poxel SA
Sponsor class: INDUSTRY
First posted: 2015-02-26
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the pharmacokinetics of single and repeated doses of imeglimin in healthy Japanese subjects, and the safety and tolerability of single and repeated doses of imeglimin in healthy Japanese subjects.

Detailed description: Combined single and repeated dose groups with 3 escalating doses

Eligibility criteria: Inclusion Criteria:

* Male or female Japanese subjects, deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
* Body mass index in the range 18.0-25.0 kg/m2
* Willing to use reliable contraception
* Able to give fully informed written consent.

Exclusion Criteria:

* Pregnant or lactating woman, or sexually active woman of child-bearing potential not using reliable contraception
* Clinically relevant abnormal findings at the screening assessment
* Clinically significant vital signs outside the acceptable range at screening
* Clinically relevant abnormal medical history, surgery or concurrent medical condition
* Acute or chronic illness
* Estimated glomerular filtration rate less than 80 mL/min/1.73 m2
* Severe adverse reaction to any drug or sensitivity to the trial medication or its components
* Significant food allergy; vegetarian or vegan
* Use of vitamins, herbal medicines, or over-the-counter medication (with the exception of paracetamol \[acetaminophen\]) within 7 days before first dose of trial medication, or prescribed medication during the 14 days before first dose of trial medication
* Participation in other clinical trials of unlicensed or prescription medicines, or loss of more than 400 mL blood, within the 3 months before first dose of trial medication
* Drug or alcohol abuse
* Smoking of more than 5 cigarettes daily
* Possibility that subject will not cooperate
* Positive test for hepatitis B \& C, HIV
* Objection by a General Practitioner.

Primary outcomes:
measure: PK parameters of imeglimin after single and repeated doses: - Cmax: peak plasma concentration after dosing, AUC0-∞: area under the concentration-time curve from 0 extrapolated to infinite time, - Tmax: time of peak plasma concentration of imeglimin
timeFrame: From baseline to Day 13
measure: Safety and tolerability of imeglimin: laboratory assessments
timeFrame: From baseline to Day 13
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Medicines Research (HMR)
Study officials:
References:
Clinical trial NCT05929638: Aromatherapy With Lavender Essential Oil in Patients With Multiple Sclerosis
Official title: The Effect of Aromatherapy With Lavender Essential Oil on the Sleep and Fatigue Level of Patients With Multiple Sclerosis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aromatherapy
Randomized Controlled Trial
Multiple Sclerosis
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study was conducted with patients with Multiple Sclerosis (MS) who applied to the Neurology Outpatient Clinic of Atatürk University Research Hospital, met the inclusion criteria and agreed to participate in the study. At the time of the study, 96 patients were interviewed. 26 patients were excluded from the study because they did not meet the research criteria, and 70 multiple sclerosis patients constituted the research sample. 1 person from the control group and 1 person from the experimental group did not continue to work and 1 person developed a lavender allergy. The study was completed with 63 multiple sclerosis patients.

Detailed description: Patient Description, Fatigue Severity Scale and Pittsburgh Sleep Quality Index were applied to the patients at the first interview. Lavender oil in 15 ml opaque dark colored bottles closed with metal caps to prevent volatility to the venture group (Oleum Lavandula Angustifolia/ HACCP, Halal Food, ISO 22000:2005, ISO 14001:2015, ISO 9001:2015, ISO 45001:2018) certificates) and 40 2×2 cotton pads were delivered. Studies have reported that the most common use of aromatherapy is three drops, three days a week. Patients were asked to apply lavender oil 30 minutes before going to bed. Deep breathing increases the concentration of aromatic substances in the body. The time it takes for essential oils to be absorbed into the blood circulatory system is about 30 minutes for complete absorption by the body.

Eligibility criteria: Inclusion Criteria:

* Being 18 years or older,
* Having been diagnosed with MS at least 1 year ago,
* Verbal communication (hearing and speaking)
* No problem with sense of smell,
* Not having an allergy to lavender,
* Having fatigue and sleep problems for the last 3 months,
* Not applying an intervention that helps to fall asleep,
* Pittsburgh Sleep Quality Index ≥5,
* Fatigue Severity Scale ≥4.

Exclusion Criteria:

* Having had an attack in the last month,
* Having DSM-IV Axis I disorder,
* Pregnancy,
* Using sleeping pills,
* Breastfeeding

Primary outcomes:
measure: Fatigue Severity Scale -FSS
timeFrame: two week
measure: Pittsburgh Sleep Quality Index (PUKI)
timeFrame: Two week
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk Unıversity
Study officials:
affiliation: Ataturk University
name: Nihan Türkoğlu, Assist.Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT00524238: Metabolic Changes in Hypothyroid Patients
Official title: Impact of Hypothyroidism on Glucose, Lipid, and Amino Acid Turnover
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothyroidism
Keywords: hypothyroidism
glucose turnover
clamp
insulin resistance
lipid turnover
amino acid turnover
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2007-09-03
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Hypothyroidism is a frequent condition in danish women, but often overlooked. Along with fatigue one of the main symptoms is weight gain as a result to significantly decreased energy expenditure.

This study was undertaken to elucidate changes in glucose, lipid and amino acid turnover in these patients.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed hypothyroidism with tsh over 40 mU/L, etiology chronic autoimmune thyroiditis
* Healthy controls matched regarding sex, age and body mass index

Exclusion Criteria:

* Pregnancy, breastfeeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University, Clinical Institute
name: Signe Gjedde, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gjedde S, Gormsen LC, Riis AL, Jorgensen JO, Rungby J, Moller N, Weeke J, Pedersen SB. Reduced expression of uncoupling protein 2 in adipose tissue in patients with hypothyroidism. J Clin Endocrinol Metab. 2010 Jul;95(7):3537-41. doi: 10.1210/jc.2009-0907. Epub 2010 Apr 28.
Clinical trial NCT00207038: Airway Inflammation in Swimmers
Official title: Airway Inflammation in Swimmers: Development and Risk Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma
Airway inflammation
Sport
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Imperial College London
name: Sygekassernes Helsefond
name: Toyota-Fonden
name: Team Denmark
name: Anti Doping Danmark
name: Ragnhild Ibsens Legat For Medicinsk Forskning
name: Kong Christian IX og Dronning Louises Jubilæumslegat
name: Kong Christian den Tiendes Fond
First posted: 2005-09-21
Enrollment: 90
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elite swimmers

Brief summary: Studies have shown that the prevalence of respiratory symptoms, airway hyperresponsiveness (AHR) and asthma is high and increasing in elite athletes. The inflammation seen in the airways of elite athletes might differ from the inflammation seen in the airways of "ordinary" asthmatics and it might represent a different kind of asthma.

The primary purposes are

1. To investigate the type of airway inflammation in young swimmers.
2. To investigate the acute changes in airway inflammation after a short training session.


Eligibility criteria: Inclusion Criteria:

* Swimmer

Exclusion Criteria:

* Current smoker or more than 3 pack-years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Respiratory and Allergy Research Unit, Department of Internal Medicine, Bispebjerg Hospital, University Hospital of Copenhagen
Study officials:
affiliation: Respiratory and Allergy Reseach Unit, Department of Internal Medicine, Bispebjerg Bakke 23, Bispebjerg Hospital, University Hospital of Copenhagen, DK-2400 Copenhagen NV, Denmark
name: Lars Pedersen, MD
role: STUDY_CHAIR
References: