louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04654065: Study to Evaluate Oral Mucosa Absorption of IN-C004 in Healthy Volunteers
Official title: An Open-label, Single-dose Clinical Study to Evaluate Oral Mucosa Absorption of IN-C004 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2020-12-04
Enrollment: 6
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To evaluate whether IN-C004 absorbs oral mucosa in healthy volunteers.

Detailed description: An Open-label, Single-dose Clinical Study

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) ≥19.0 kg/m2 and ≤27.0 kg/m2 with a body weight ≥ 45 kg at screening.

Exclusion Criteria:

* History or evidence of clinically significant disease
* History of drug/alcohol abuse
* Participated in other studies and received investigational products within 6 months prior to the first study dose.
* Not able to use a medically acceptable contraceptive method throughout the study.

Primary outcomes:
measure: AUCt of tegoprazan
timeFrame: pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2 hours
measure: Cmax of tegoprazan
timeFrame: pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2 hours
measure: Tmax of tegoprazan
timeFrame: pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
Study officials:
affiliation: Chonbuk National University Hospital
name: Min-Gul Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03300765: Trail Evaluating Apatinib With IMRT for Inoperable or Iodine Refractory Thyroid Cancer
Official title: Intensity Modulated Radiation Therapy Combined With Apatinib for Inoperable or Iodine Refractory Thyroid Cancer: A Phase II Single-arm Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Thyroid Cancer
Keywords: Thyroid Cancer
Apatinib
Intensity modulated radiation therapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the efficacy and safety of intensity modulated radiation therapy combined with apatinib for inoperable or iodine refractory thyroid cancer.


Eligibility criteria: Inclusion Criteria:

* Ability to understand character and individual consequences of the clinical trial. Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial;
* Aged ≥ 18 years old;
* Pathologically confirmed inoperable or iodine refractory thyroid cancer, or postoperative residual disease detected by imaging studies, or progression disease within 12 months before enrollment. (all with measurable disease ≥10mm according to RECIST 1.1);
* ECOG0-2;
* Adequate laboratory values within 14 dyas of enrollment to study defined as follows: N ≥ 1500/mm\^3; PLT ≥ 80,000/mm\^3; HB≥90g/L;total bilirubin \< 1.25ULN; AST/ALT \< 2.5 ULN or \< 5 ULN with metastasis; SCr ≤1ULN; CCR \> 50ml/min;
* The survival period is expected to be greater than 3 months;
* Willing to accept adequate contraception for patients with childbearing potential.

Exclusion Criteria:

* Take chemotherapeutic chemotherapy (the use of low-dose chemotherapy for radiosensitization was allowed) or thalidomide and its derivative treatments;
* Take VEGFR-TKI within 1 month, such as vandetanib, cabozantinib, lenvatinib, sunitinib and sorafenib;
* Allergic to apainib;
* Uncontrolled high blood pressure and heart disease;
* Patients with gastrointestinal bleeding risk;
* Coagulation disorders(INR\>1.5×ULNAPTT\>1.5×ULN);
* Uroprotein positive (Uroprotein≥2+ or 24-hour urinary protein quantity \>1.0g);
* Pregnant or lactating women.

Primary outcomes:
measure: Progression Free Survival
timeFrame: 3-year
Secondary outcomes:
measure: Short-term treatment response rate
timeFrame: Three months after completion of the therapy
measure: Overall survival
timeFrame: 3-year
measure: Time to Response
timeFrame: From the initial treatment to first response, up to 3 years
measure: Duration of Response
timeFrame: From first response to disease progression, up to 3 years
measure: Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03
timeFrame: Time interval from start to 3 months after completion of the therapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT00243165: Lifemel Honey to Reduce Leucopenia During Chemotherapy
Official title: Lifemel Honey During Adjuvant Chemotherapy for Breast Cancer Patients to Prevent Leucopenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
honey
myelosuppression
chemotherapy
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Zuf Globus Laboratories Ltd.
First posted: 2005-10-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will include 60 patients with early breast cancer referred to receive adjuvant chemotherapy with AC ( adriamycin- cyclophosphamide) or CAF ( adriamycin- cyclophosphamide- 5- fluorouracil ) combinations. These patients will receive every day one spoon of Lifemel honey or regular honey ( double blind)- during the adjuvant chemotherapy .Every week a WBC count will be performed in order to record the influence of Lifemel on myelotoxicity.


Eligibility criteria: Inclusion Criteria:

* breast cancer patient treated with adjuvant chemotherapy
* PS = 2 or less

Exclusion Criteria:

* none

Primary outcomes:
measure: Prevention of myelotoxicity-every week during chemotherapy.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Health Care Campus
name: Georgeta Fried, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02464865: Thiamin Deficiency in Obese Thai Children
Official title: Thiamin Deficiency in Obese Thai Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Child
Thiamine Deficiency
Keywords: thiamine deficiency
obese children
Thai
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 124
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study is aimed to assess the prevalence of thiamin deficiency in obese Thai children.

Detailed description: This study is a cross-sectional study. The objectives of the study are to determine the prevalence of thiamin deficiency in obese Thai children and to assess the associations of dietary factors and thiamin deficiency.

Eligibility criteria: Inclusion Criteria:

* obese : weight for height \> median + 3 standard deviations
* simple obesity

Exclusion Criteria:

* pathological obesity
* chronic diseases e.g. cerebral palsy, metabolic disease, etc.
* diseases of red blood cells
* on medication e.g. steroid, multivitamins, thiamine-containing vitamins, diuretic drugs
* hemodialysis or peritoneal dialysis
* bariatric surgery

Primary outcomes:
measure: abnormal thiamin pyrophosphate effect
timeFrame: 7 days
Secondary outcomes:
measure: consumption of thiaminase-containing foods and thiamin antagonist-containing foods
timeFrame: 7 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
Study officials:
affiliation: Mahidol University
name: Narumon Densupsoontorn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Densupsoontorn N, Jirapinyo P, Kangwanpornsiri C. Micronutrient deficiencies in obese Thai children. Asia Pac J Clin Nutr. 2013;22(3):497-503. doi: 10.6133/apjcn.2013.22.3.06.
Clinical trial NCT03837665: Efficacy of Platelet Enriched Plasma in Preventing Surgery for Patients With Chronic Tympanic Membrane Perforation
Official title: Efficacy of Platelet Enriched Plasma in Preventing Surgery for Patients With Chronic Tympanic Membrane Perforation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Tympanic Membrane Perforation
Keywords: Platelet Rich Plasma
TM perforations
Hearing loss
Hole in the eardrum
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 1
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: By doing this study, researchers hope to find out if platelet rich plasma (PRP) can heal holes in the eardrum as an alternative to surgery.


Eligibility criteria: Inclusion Criteria:

* Patients who meet criteria for tympanoplasty procedure
* Willing to comply with the protocol and attend all study visits
* Able to provide written informed consent

Exclusion Criteria:

* Patients who have previously undergone middle ear or lateral skull base surgery
* Patients who would not qualify for a tympanoplasty
* Any type of platelet disorder, cancer, or ongoing systemic infection
* Any type of hemodynamic instability, septicemia, infection, tobacco use, any use of steroids to the ear drums
* Type I diabetes or other autoimmune pathology

Primary outcomes:
measure: Prevention of Patients Requiring Surgery
timeFrame: 6 Weeks
Secondary outcomes:
measure: Time to Healing
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Hinrich Staecker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05920265: Quadratus Lumborum Plain Block Versus Fascia Iliac Block
Official title: Quadratus Lumborum Plain Block Versus Fascia Iliac Block in Hip Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Keywords: QLB
Fascia Iliac Block
hip surgery
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: evaluation the efficacy of Quadratus Lumborum plain Block Versus Fascia Iliac Block for postoperative pain after hip surgery


Eligibility criteria: Inclusion Criteria:

* 18-70 years
* fracture hip

Exclusion Criteria:

* patients refuse
* mental problem patient with any coagulation deficiency or bleeding problems patient with allergy to investigated medications,

Primary outcomes:
measure: analgesic consumption
timeFrame: 24 hour
Secondary outcomes:
measure: Visual analogue pain score
timeFrame: 24 hour
measure: first analgesic demand
timeFrame: 24 hour
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University
state: Minia
Study officials:
affiliation: minia university hospital/ faculty of medicine
name: abeer M hassaneen, Ass. professor
role: STUDY_DIRECTOR
affiliation: minia university hospital/ faculty of medicine
name: ahmed H Mohamed, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT00929565: Urokinase Like Plasminogen Activator Levels in Patients Undergoing Bronchoscopy
Official title: Utility of Serum and Bronchoalveolar Fluid Urokinase Like Plasminogen Activator Levels in Defining Patients at Higher Risk of Hemoptysis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemoptysis
Keywords: hemoptysis
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2009-06-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from the VAMC in Oklahoma city

Brief summary: Some of the risk factors for bleeding following bronchoscopy is having a malignancy or an immunocompromised state. The etiology of this remains uncertain. The investigators suspect that individuals with malignancy have abnormalities involving certain factors that influence the coagulation pathway.

The investigators plan to measure these factors prior to and after bronchoscopy.

Detailed description: This is a prospective observational study looking at some coagulation factors in individuals with lung cancer. We are looking at BAL and plasma. We would like to see if there is a difference in the levels and if this is the reason behind the higher incidence of hemoptysis in patients with lung cancer.

Eligibility criteria: Inclusion Criteria:

* Any patient scheduled to undergo bronchoscopy

Exclusion Criteria:

* Patients with evidence of coagulopathy either iatrogenic or the result of disease process - coagulopathy defined as elevated prothrombin time, activated partial thromboplastin time or platelet count less than 100,000
* Patients not scheduled to undergo bronchoalveolar lavage (BAL)

Primary outcomes:
Secondary outcomes:
measure: Volume of blood loss during the procedure
timeFrame: 1 day
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: VA Medical Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Jijo John, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01463865: Selective Block of the Axillary Nerve in Postoperative Pain Management
Official title: Selective Block of the Axillary Nerve in Postoperative Pain Management, a Randomised, Blinded, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Hillerod Hospital, Denmark
Sponsor class: OTHER
First posted: 2011-11-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study the investigators wish to compare the effect of a selective axillary nerve block to placebo in patients undergoing arthroscopic shoulder surgery.

It is the investigators hypothesis that the amount of morphine consumption in the first 4 hours postoperatively in the intervention group will be significant lower than in the placebo group.


Eligibility criteria: Inclusion Criteria:

* Subjects undergoing arthroscopic shoulder surgery
* Age between 18 and 80 years
* ASA 1-3
* BMI between 18 and 35 kg/m2
* Subjects which have given their written informed consent

Exclusion Criteria:

* Subjects unable to cooperate to the investigation
* Subjects not understanding or speaking danish
* Subjects allergic to intervention drugs
* Daily use of strong analgesics (morphine, oxycontine, ketogan)
* Alcohol or medicine misuse
* Failure of nerve block

Primary outcomes:
measure: Morphine consumption
timeFrame: 0-4 hours postoperatively
Secondary outcomes:
measure: Visual analogue scale (VAS) score
timeFrame: 0-12 hours and 12-24 hours postoperatively
measure: Total morphine consumption
timeFrame: 0-24 hours postoperatively
measure: Postoperative nausea and vomiting (PONV)
timeFrame: 0-4, 0-12 and 12-24 hours postoperatively
measure: Escape block
timeFrame: 0-4 hours postoperatively
measure: Bolus morphine 5 mg iv
timeFrame: 0-4 hours postoperatively
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Aleris-Hamlet Hospital
Study officials:
References:
citation: Rothe C, Asghar S, Andersen HL, Christensen JK, Lange KH. Ultrasound-guided block of the axillary nerve: a volunteer study of a new method. Acta Anaesthesiol Scand. 2011 May;55(5):565-70. doi: 10.1111/j.1399-6576.2011.02420.x.
citation: Rothe C, Lund J, Jenstrup MT, Steen-Hansen C, Lundstrom LH, Andreasen AM, Lange KHW. A randomized controlled trial evaluating the impact of selective axillary nerve block after arthroscopic subacromial decompression. BMC Anesthesiol. 2020 Jan 31;20(1):33. doi: 10.1186/s12871-020-0952-y.
Clinical trial NCT00435565: Severe Hypoglycemia in Pregnant Women With Type 1 Diabetes
Official title: Severe Hypoglycemia in Pregnant Women With Type 1 Diabetes. Incidence, Risk Markers and Possibilities for Prevention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Diabetes
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2007-02-15
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Background:

The risk of stillbirth and preterm delivery is three times increased among pregnant women with type 1 diabetes compared with healthy pregnant women. Normal blood glucose levels are mandatory in order to prevent these complications. Severe hypoglycemia (requiring assistance from another person) is the decisive limiting factor for obtaining near-normal blood glucose regulation in pregnant women with type 1 diabetes. Severe hypoglycemia occurs in about one third of pregnancies complicated with type 1 diabetes and can result in unconsciousness, traffic accidents and deaths.

Aim: To test the following hypotheses:

1. Severe hypoglycemia is frequent in pregnancy complicated by type 1 diabetes with the highest incidence in gestational weeks 8-16 and the lowest incidence in gestational weeks 28-34
2. Predictors for severe hypoglycemia during pregnancy complicated with type 1 diabetes can be identified at the first pregnancy visit
3. Possible pathophysiological mechanisms include changes in the growth hormone system and in the renin-angiotensin-system during pregnancy

Methodology:

One hundred and eight pregnant women with type 1 diabetes are consecutively and prospectively included. In connection with the clinical control at the first pregnancy visit at week 9 and in gestational weeks 14, 22, 28, 34 and one day postpartum the following tests are carried out:

The patients are asked to answer a validated questionnaire about mild and severe hypoglycemia and hypoglycemia-associated factors such as blood glucose level during hypoglycemia, the degree of awareness, pregnancy-associated nausea and vomiting, insulin type and dose etc. Other medication, exercise habits, coffee- and alcohol intake, smoking and social status will be recorded. In case of severe hypoglycemia a structured interview concerning the episode will be performed within 24 hours. Blood glucose, HbA1c, the degree of insulin resistance and the levels of IGF1, placenta growth hormone and of the renin-angiotensin-system will be monitored.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* Pregnancy before gestational week 14

Exclusion Criteria:

* Other diseases that might influence the risk of severe hypoglycemia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rigshospitalet, Denmark
name: Lene R Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02020265: fMRI Based EEG Neurofeedback as a Method of Enhancing Emotional Resilience Among Soldiers
Official title: Longitudinal Study of the Effect of Neurofeedback Training on Soldiers Emotional Regulation Ability and Mental Resilience to Stress.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress
Depression
Keywords: stress and depression related symptoms
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-12-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: EEG protocols exist for reducing stress and improve PTSD symptoms (A/T EEG protocols, Peniston, 1993, Hammond, 2005) however; our innovative EEG-NF LMI approach intends to be more amygdala/stress specific and therefore more efficient. Three groups of soldiers, while in operational activity will go through 24 sessions of 3 different methods of EEG-NF; our newly developed NF via MLI, a standard procedure for NF via A/T and a placebo NF. Difference between the groups in regard to their emotion regulation capability will be tested by fMRI with regard to amygdala activation following EEG-NF LMI as well as two stress challenge tests.


Eligibility criteria: Inclusion Criteria:

* soldiers in preliminary combat training

Exclusion Criteria:

* known mental disorders or neuro-pathology

Primary outcomes:
measure: Change from baseline at Amygdala modulation ability
timeFrame: At baseline and after 6 month of neurofeeback training.
Secondary outcomes:
measure: Change from baseline in Emotion regulation ability
timeFrame: At baseline and after 6 month of neurofeedback training
Other outcomes:
Locations:
city: Tel_Aviv
country: Israel
facility: Tel-Aviv Sourasky medical center
state: Choose One
Study officials:
References: