louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04278391: Pharmacokinetics and Safety Between "DWJ1421" and "DWC201903" in Healthy Male Volunteers
Official title: A Randomized, Open Label, Single Dose, Crossover Study to Compare the Pharmacokinetics and Safety Between "DWJ1421" and "DWC201903" in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2020-02-20
Enrollment: 40
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a randomized, open label, single dose, crossover study to compare the pharmacokinetics and safety between "DWJ1421" and "DWC201903" in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Between 19 aged and 45 aged in healthy male adult
* Body weight more than 50kg
* Body Mass Index more than 18.0 and under 27.0

Exclusion Criteria:

* Those who have clinical significant liver, kidney, digestive system, respiratory, endocrine, nervous system, hematology and oncology, cardiovascular, urinary diseae or past history
* Those who have a gastrointestinal disease history that can effect drug absorption or surgery
* Those who have hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Investigational product

Primary outcomes:
measure: Cmax
timeFrame: 0, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14h
measure: AUClast
timeFrame: 0, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14h
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Bundang CHA Medical Center
state: Gyeonggi-do
Study officials:
References:
citation: Shin W, Yang AY, Yun H, Cho DY, Park KH, Shin H, Kim A. Bioequivalence of the pharmacokinetics between tofacitinib aspartate and tofacitinib citrate in healthy subjects. Transl Clin Pharmacol. 2020 Sep;28(3):160-167. doi: 10.12793/tcp.2020.28.e13. Epub 2020 Sep 21.
Clinical trial NCT00442091: Dandelion Juice in the Treatment of Dyshidrotic Hand Eczema
Official title: Dandelion Juice in the Treatment of Dyshidrotic Hand Eczema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vesicular Palmoplantar Eczema
Pompholyx
Keywords: Dandelion
herbal remedy
hand eczema
Compositae
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2007-03-01
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Dandelion juice has been used in herbal medicine for at least 1000 years. Vesicular hand eczema is a rare, but difficult to treat, type of hand eczema. One case report has shown that ingestion of dandelion juice could induce a beneficial effect on this type of eczema. The purpose of this study is to test whether this effect can be retrieved in other patients.

Detailed description: Dandelion juice has been used in herbal medicine for at least 1000 years. One case report has shown a beneficial effect of this herbal remedy on dyshidrotic hand eczema, and the purpose of this pilot study is to test whether this effect can be retrieved in other patients.

The patients are recruited from our out-patient clinic. Only patients with negative patch tests to Compositae are offered treatment with dandelion juice for 20-30 days.

Eligibility criteria: Inclusion Criteria:

* Adult patients with dyshidrotic eczema for at least 1 year and negative patch test reactions to Compositae (tested within the last 3 years) and normal renal and hepatic blood tests.

Exclusion Criteria:

* Treatment with systemic steroids or other immunosuppressive/-modulating drugs, including UV therapy, within the last 3 months.
* Pregnancy, lactation.
* Compositae contact allergy.
* Liver or gall bladder disease.
* Abnormal renal or hepatic blood tests.

Primary outcomes:
measure: Improvement in dyshidrotic hand eczema in the study period assessed by HECSI score.
timeFrame: 3-4 weeks
Secondary outcomes:
measure: Improvement in dyshidrotic eczema in the study period assessed by the patient (Visual Analog Scale).
timeFrame: 3-4 weeks
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Dermatology, Odense University Hospital
Study officials:
affiliation: Department of Dermatology, Odense University Hospital, DK-5000 Odense C
name: Evy Paulsen, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01666691: An Efficacy, Safety and Pharmacokinetics Study of Beloranib (ZGN-440 for Injectable Suspension) in Obese Subjects
Official title: Randomized, Double-Blind, Placebo Controlled, Dose Ranging Phase 2 Trial of Beloranib (ZGN-440 for Injectable Suspension), A Novel Methionine Aminopeptidase 2 Inhibitor, in Obese Subjects to Evaluate Weight Reduction, Safety, and Pharmacokinetics Over 12 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Obese
Obesity
Overweight
Weight loss
Weight reduction
Beloranib
Lead sponsor: Zafgen, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-16
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate weight reduction, safety and pharmacokinetics for certain doses of beloranib (ZGN-440 for injectable suspension) administered as twice-weekly subcutaneous injections for 12 weeks.

Detailed description: This protocol is designed to test the safety and efficacy of a drug called beloranib (ZGN-440 for injectable suspension). It is to be tested for its ability to reduce weight in obese subjects. The study will provide information on how much ZGN-440 gets into the blood, how long it stays in the body, and how it affects other biological markers.

Eligibility criteria: Inclusion Criteria:

* Obese volunteers weighing ≥ 50 kg
* BMI ≥ 30 and ≤ 50 kg/m2
* Stable body weight during the past 2 months
* Type 2 diabetes mellitus is allowed

Exclusion Criteria:

* Use of weight loss agents in the past month
* Current, clinically significant eating disorder
* Type 1 diabetes mellitus

Primary outcomes:
measure: Safety and tolerability of beloranib (ZGN-440 for injectable suspension) administered subcutaneously for 12 weeks
timeFrame: Up to 26 weeks
measure: Weight loss and responses in metabolic biomarkers over a dose range of ZGN-440
timeFrame: Up to 13 weeks
Secondary outcomes:
measure: Pharmacodynamics over a dose range of beloranib
timeFrame: Up to 12 weeks
measure: Compare the plasma pharmacokinetic profile of beloranib administered subcutaneously with the profiles obtained previously using an alternative formulation administered subcutaneously and with ZGN-433 (beloranib hemioxalate) administered intravenously
timeFrame: Up to 12 weeks
measure: Apparent bioavailability over a dose range of beloranib
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Q-Pharm Clinics, Royal Brisbane and Women's Hospital
state: Queensland
city: Adelaide
country: Australia
facility: CMAX
state: South Australia
city: Perth
country: Australia
facility: Linear Clinical Research Ltd
state: Western Australia
Study officials:
affiliation: Q-Pharm Clinics, Royal Brisbane and Women's Hospital
name: J K Marjason, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02008591: Comparison of Epidural Labor Pain Relief Techniques on Maternal and Fetal Outcomes
Official title: Comparison of Epidural Labor Pain Relief Techniques on Maternal and Fetal Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Laboring Women Requesting Neuraxial Labor Analgesia
Keywords: Neuraxial Technique
Epidural Technique
Dural Puncture Epidural Technique
Combined Spinal Epidural Technique
Labor Analgesia
Obstetric
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with computer generated (Microsoft Excel 2015) assignment placed in sealed envelopes.
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare the onset and duration of the initial dose of medications given through three different epidural (conventional epidural, combined spinal epidural and dural puncture epidural) techniques for labor pain relief.

The secondary objective of this study is to compare the fetal effects of these three epidural labor analgesia techniques.


Eligibility criteria: Inclusion Criteria:

* 1. Nulliparous (first baby) parturient 2. Singleton, vertex gestation at term (37-42 weeks) 3. Less than 5 cm dilation 4. Desires an epidural technique for labor analgesia

Exclusion Criteria:

- 1. Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e preeclampsia, gestational diabetes) 2. Any contraindication to the administration of an epidural technique 3. History of hypersensitivity or idiosyncratic reaction to local anesthetic or opioid medications 4. Current or historical evidence of a disease which may result in the risk of a cesarean delivery.

5. Evidence of anticipated fetal anomalies

Primary outcomes:
measure: Maternal Outcomes
timeFrame: Participants will be followed for the duration of labor analgesia from initiation to delivery, an expected average of 12 hours
Secondary outcomes:
measure: Fetal Outcomes
timeFrame: Participants will be followed for the duration of labor analgesia from initiation to delivery, an expected average of 12 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Lawrence C Tsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03458091: Evaluation of Lung Atelectasis During Apneic Oxygenation Using THRIVE in Adults During Laryngeal Surgery.
Official title: Evaluation of Lung Atelectasis During Apneic Oxygenation Using Trans Nasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) in Adults During Laryngeal Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 30
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: Oxygenation with high-flow nasal cannula with 100% oxygen have now been evaluated in a number of studies and the data are convincing. The THRIVE technique is able to oxygenate patients safely and vital parameters has been shown to be stable. But it is of great importance to evaluate this new concept regarding other potential negative physiological aspects such as lung atelectasis and inflammatory stress response before implementing it into clinical practice.


Eligibility criteria: Inclusion Criteria:

1. Adults, \>18 years old.
2. ENT-surgery where apnea is of benefit for the surgeon (eg. intraoral or laryngeal surgery).
3. Capable of understanding the study information and sign the written consent.

Exclusion Criteria:

1. ASA\>2
2. NYHA \>2
3. Pacemaker or ICD.
4. BMI \>35
5. Pregnancy
6. Manifest cardiac failure or coronary disease
7. Severe gastrointestinal reflux.
8. Neuromuscular disorder

Primary outcomes:
measure: Electrical impedans tomography
timeFrame: baseline, intraoperative, 2 hours after start of intervention
Secondary outcomes:
measure: Difference in Endtidal and arterial carbon dioxide partial pressure in the end of the procedure
timeFrame: max 30 minutes after start of intervention
measure: Increase in arterial carbon dioxide during the apnea
timeFrame: max 30 minutes after start of intervention
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital and Karolinska Institutet
name: Malin Jonsson Fagerlund
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04344691: Relation Between Rectus Femoris Muscle Tension and Hamstring Strength and Activity in Healthy Sprinters
Official title: Relation Between Rectus Femoris Muscle Tension and Hamstring Strength and Activity in Healthy Sprinters
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Stretching Exercise
Keywords: muscle length
strength
sprint
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: An open-label, single-group, control, pretest-posttest clinical trial is going to be conducted, with 16 healthy sprinters. Rectus femoris length and hamstring strength and electromyography is going to be assessed at baseline, after 10 minutes control and after an static rectus femoris stretching technique.

The main objective is to register if an increase in rectus femoris stretching Range of Motion, increases hamstring strength and activity due to their antagonic relationship and their relation with pelvic tilt.


Eligibility criteria: Inclusion criteria:

* The athletes recruited have to be under regular training and competition
* Free of any symptoms, at least 3 days training weekly for the last three years
* Give written consent

Exclusion criteria:

- Subjects who have suffered lower limb or back injuries during those last three years

Primary outcomes:
measure: Rectus femoris length
timeFrame: Inmediate after intervention; up to 10 minutes
measure: Biceps femoris strength
timeFrame: Inmediate after intervention; up to 10 minutes
measure: Gluteus maximus strength
timeFrame: Inmediate after intervention; up to 10 minutes
Secondary outcomes:
measure: Rectus femoris tensomyography
timeFrame: Inmediate after intervention; up to 10 minutes
measure: Pelvic anteversion
timeFrame: Inmediate after intervention; up to 10 minutes
measure: Sprint muscle activity
timeFrame: Inmediate after intervention; up to 10 minutes
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Cnetro ragonés del Deporte
Study officials:
affiliation: Universidad Pública de Navarra
name: Alazne Ruiz de Escudero Zapico, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00152191: A Randomized Controlled Study of Postoperative Adjuvant Therapy of Uracil-tegafur (UFT) Compared With Cyclophosphamide/Methotrexate/5-fluorouracil (CMF) in Breast Cancer (NSAS-BC)
Official title: A Randomized Controlled Study of Postoperative Adjuvant Therapy of UFT Compared With CMF in High-risk Women With Axillary Node-negative Breast Cancer (NSAS-BC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 1300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled study designed to evaluate the relapse-free survival of the UFT group compared with the CMF group. Patients will be randomly assigned to receive either CMF or UFT within 12 weeks after curative resection. To evaluate treatment efficacy, data on recurrence, and survival will be collected for up to 10 years after enrollment of the final patient. To assess safety, data on adverse events will be collected for 2 years after the start of treatment. Patients'quality of life will be assessed by means of a questionnaire.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 75
* Performance status 0 or 1 (ECOG)
* Hematopoietic WBC ≥ 4,000/mm\^3 Platelet ≥ 100,000/mm\^3
* Hepatic AST and ALT ≤ 2.5 times upper limit of normal(ULN) Total bilirubin ≤ ULN
* Renal Creatinine ≤ ULN

Exclusion Criteria:

* Prior anticancer treatment

Primary outcomes:
measure: Relapse-free survival
timeFrame: every course for first three courses, then every other course
Secondary outcomes:
measure: Overall survival, adverse events, and the quality of life
timeFrame: any time
Other outcomes:
Locations:
city: 5-1-1, Tsukiji, chuo-ku
country: Japan
facility: National Cancer Center
state: Tokyo
Study officials:
affiliation: Hamamatsu Oncology Center
name: Toru Watanabe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Watanabe T, Sano M, Takashima S, Kitaya T, Tokuda Y, Yoshimoto M, Kohno N, Nakagami K, Iwata H, Shimozuma K, Sonoo H, Tsuda H, Sakamoto G, Ohashi Y. Oral uracil and tegafur compared with classic cyclophosphamide, methotrexate, fluorouracil as postoperative chemotherapy in patients with node-negative, high-risk breast cancer: National Surgical Adjuvant Study for Breast Cancer 01 Trial. J Clin Oncol. 2009 Mar 20;27(9):1368-74. doi: 10.1200/JCO.2008.18.3939. Epub 2009 Feb 9.
Clinical trial NCT05328791: Effectiveness of a Mindfulness Based Diet Program on Weight Loss
Official title: Effectiveness of a Mindfulness Based Diet Program Given to Obese Individuals on Body Weight and Eating Behaviours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
Keywords: Obesity
Weight loss
Mindfulness
Lead sponsor: Ankara University
Sponsor class: OTHER
Collaborators: name: Amasya University
First posted: 2022-04-14
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Meditation interventions, including mindfulness-based approaches, can be effective in reducing psychological stress . Mindfulness meditation, which cultivates awareness of present-moment experience with a nonjudging attitude, is theorized to promote adaptive self-regulation,which is thought to be key to maintaining long-term eating habits and appetite regulation.In the light of this information, in this study, it is aimed to observe the effect of mindfulness approach on body weight and eating behaviours.

Detailed description: The use of minfulness based programs for body weight control and stress management is increasing. One of the main reasons for this situation is that individuals care more about the diet and body weidght as a result of the increase in health concerns and stress. In addition, such cognitive support programs in the diet process provide a more comfortable and stress-free continuation of the diet. Based on the above-mentioned information; in this study, it is aimed to determine the effect of mindfulness based diet intervention on weight loss and eating behaviuors.

Individuals who meet the research criteria will randomize according to their file numbers (with the ramdomizer program) and divide into 2 groups: mindfulness group (15) and control group . Food consumption records, anthropometric measurements and eating behaviours scale of all individuals will record at the beginning and end of the study. In order to prevent interaction between individuals, all diet programs will prepare at different times and individually.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 20-65
* Being obese (BMI≥30 kg/m2)
* Volunteering to participate in research

Exclusion Criteria:

* Being pregnant/lactating
* Having a psychological problem
* Being on a followed diet program

Primary outcomes:
measure: Weight chance
timeFrame: At the end of the 2 months
Secondary outcomes:
measure: Three factor eating questionnaire (TFEQ) scale score change
timeFrame: At the end of the 2 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ümüş Özbey Yücel
state: Select An Option…
Study officials:
affiliation: Ankara University
name: ümüş Ö yücel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04625491: Location of Lower Limb Cutaneous Melanomas as a Prognostic Factor.
Official title: Lower Limb Cutaneous Melanoma: Observational Prognostic Study About Specific Location of the Primary Lesion.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cutaneous Melanoma
Anatomical Pathological Condition
Keywords: cutaneous melanoma
lower limb
prognostic
Lead sponsor: Hospital Universitario Virgen de la Arrixaca
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that were cared of cutaneous melanoma on the lower limb.

Brief summary: Observational study to know the relevance of specific anatomical location of cutaneous melanoma on lower limbs.

Detailed description: Ambispective (retrospective and prospective) observational register of patients with cutaneous melanoma on lower limbs are grouped in 1) proximal (thigh), 2) medium (leg), and 3) distal (ankle and foot) location. Analysis of melanoma-specific overall and disease-free survival will be made, as well as multivariant analysis for prognostic variables including anatomical location.

Eligibility criteria: Inclusion Criteria:

* Cutaneous melanoma on the lower limb

Exclusion Criteria:

* Incomplete staging

Primary outcomes:
measure: Melanoma-specific overall survival
timeFrame: Ten years
measure: Melanoma-specific disease-free survival
timeFrame: Ten years
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Hospital Universitario "Virgen de la Arrixaca"
Study officials:
affiliation: Associate Professor of Surgery
name: Antonio Piñero-Madrona, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: