louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01427686: Dopamine Versus Dobutamine for Treatment of Arterial Hypotension in Term and Preterm Neonates
Official title: Effect of Dobutamine as Compared to Dopamine on Cerebral Oxygenation, Mean Arterial Pressure and Cerebral Hemodynamics in Term and Preterm Neonates With Arterial Hypotension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Arterial Hypotension
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2011-09-01
Enrollment: 20
Sex: ALL
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effects of Dobutamine as compared to Dopamine in term and preterm neonates with arterial hypotension on cerebral and renal oxygenation, fractional tissue oxygen extraction, mean arterial blood pressure and cardiac output.

The investigators hypothesize that Dopamine has a stronger effect on blood pressure than Dobutamine but Dobutamine has a stronger effect on cerebral oxygenation and cardiac output than Dopamine.


Eligibility criteria: Inclusion Criteria:

* fluid refractory arterial hypotension
* newborn infant below 44 weeks postmenstrual age
* parental informed consent

Exclusion Criteria:

* preterm infant below 28 weeks postmenstrual age during the first week of life
* congenital life-threatening malformations
* decision for palliative care
* hemorrhagic shock
* other obvious cause for arterial hypotension that requires immediate specific treatment, e.g. tension pneumothorax

Primary outcomes:
measure: Cerebral tissue oxygen saturation
timeFrame: during study medication
Secondary outcomes:
measure: Cardiac output
timeFrame: during treatment
measure: Cardiac output
timeFrame: during study medication
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University Medical Center, Ulm University
state: Baden-Württemberg
Study officials:
affiliation: University of Ulm
name: Manuel B Schmid, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02725086: Evaluation of Pharmacokinetic/Pharmacodynamic Properties and Safety of Leucostim® Compared to Neupogen® in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-03-31
Enrollment: 56
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Randomized, Open-label, Two-way Crossover, Open-label Clinical Trial to Compare Pharmacokinetic/Pharmacodynamic Properties and Safety after Subcutaneous Administration of Leucostim® and Neupogen® in Healthy Adult Volunteers


Eligibility criteria: Inclusion Criteria:

* Age 19 - 45 years
* BMI 18.5 - 25.0 kg/m2
* Value of ANC(absolute neutrophil count) had to be inside the normality range at the screening

Exclusion Criteria:

* Subjects with a history or presence of clinically relevant hypersensitivity reaction to investigational drugs (G-CSF) or their ingredients/additives
* Subjects with a clinically relevant history of allergic reaction
* Subjects with a history of acute infectious diseases within 2 weeks prior to administration of investigational products
* At the investigator's discretion, subjects who is considered inappropriate to participate in the study due to any conditions including screening results

Primary outcomes:
measure: AUCinf of Filgrastim
timeFrame: 0~48 hr
measure: Cmax of Filgrastim
timeFrame: 0~48 hr
measure: AUEC0-t of ANC(absolute neutrophil count)
timeFrame: 0~120 hr
measure: Emax of ANC(absolute neutrophil count)
timeFrame: 0~120 hr
Secondary outcomes:
measure: Tmax of Filgrastim
timeFrame: 0~48 hr
measure: AUC0-t of Filgrastim
timeFrame: 0~48 hr
measure: CL/F of Filgrastim
timeFrame: 0~48 hr
measure: Vd/F of Filgrastim
timeFrame: 0~48 hr
measure: AUEC0-t of CD34+ cell count
timeFrame: 0~312 hr
measure: Emax of CD34+ cell count
timeFrame: 0~312 hr
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine
state: Seodamun-gu
Study officials:
References:
Clinical trial NCT04976686: Low Carbohydrate Small Intestine Study
Official title: Studying the Impact of a Low Carbohydrate Diet on the Small Intestinal Microbiota
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diet, Healthy
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: First phase will be purely observational, second phase involves diet modification
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators will recruit probands with a ileo- or colostoma that are otherwise in good general health and analyse the stomal fluids for their microbiota composition. Sampling will be performed over a time span of 28 days, after 14 days probands will modify their base-line diet to a low carbohydrate diet.

Detailed description: Additionally to stoma fluids which will be analyzed for their microbiota composition the investigators will also collect skin samples to analyze for microbiota composition and urine to analyze for metabolite composition.

Low carbohydrate diet will allow for consumption of 80g complex carbohydrates per day, simple sugars will have to be avoided completely

Eligibility criteria: Inclusion Criteria:

* Ileostomy or colostomy
* Good general health
* Written informed consent

Exclusion Criteria:

* Major metabolic diseases that prevent adherence to low carbohydrate diet
* Participation in other clinical trial interfering with study protocol

Primary outcomes:
measure: Assessment of microbiota profile by 16S sequencing before and after diet modification for significant differences
timeFrame: 28 days
Secondary outcomes:
measure: Relative changes of total metabolite abundance in urine
timeFrame: 28 days
measure: Analysis of microbiota metabolic potential (microbiome DNA coding for enzymes) after shotgun sequencing
timeFrame: 28 days
measure: Analysis of microbiota biomass
timeFrame: 28 days
measure: Changes of further metagenomic microbiome composition (viral, eucaryotic DNA)
timeFrame: 28 days
measure: Culturing of microbiota if appropriate (in vitro)
timeFrame: 28 days
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital
Study officials:
affiliation: University Clinic for Visceral Surgery and Medicine
name: Benjamin Misselwitz, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02450786: Effect of Donepezil on Cognition in Parkinson's Disease With Mild Cognitive Impairment (PD-MCI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Parkinson's Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There have been growing interest in identifying Parkinson's disease (PD) patients with mild cognitive impairment (MCI) which is susceptible to progress to PD dementia(PDD). PD-MCI is known to significantly correlates with low cerebrospinal beta-amyloid 1-42 and 1-40 levels, in which suggest the existence of something common with Alzheimer's dementia. PDD have showed more cholinergic deficits than Alzheimer's dementia and responds to donepezil. The investigators assume that PD-MCI patients also have cholinergic deficits. Donepezil improves cognition, and seems to be well tolerated and not to worsen parkinsonism in patients with cognitive impairment. Donepezil produced similar improvements in cognition and behaviour in DLB and PDD. This supports the hypothesis that the two disorders are closely related clinically and neurobiologically. Larger scale, placebo controlled clinical trials are needed to provide an evidence base to guide the clinical use of cholinesterase inhibitors in Lewy body disease.

It is believed that earlier intervention, later appearance of dementia should be needed to lower the socioeconomic costs and to improve the quality of life on patients and caregivers. The investigators anticipate that donepezil may delay the development of dementia in patients with PD-MCI.


Eligibility criteria: Inclusion Criteria:

* Age more than 40 years old
* Clinical diagnosis of PD established by Queen Square Brain Bank Criteria
* Stable dose of levodopa at least 3 months before the study enrollment
* Diagnosis of MCI in PD according to the Movement Disorder Society (MDS) task force guideline

Exclusion Criteria:

* Diagnosis of Dementia
* Hypersensitivity to piperidine derivatives
* Concomitant anticholinergics and cholinergic agents
* Severe cardiac arrhythmia: Sick sinus syndrome, complete AV block, Uncontrolled arrhythmia, history of ventricular fibrillation

Primary outcomes:
measure: Rate of cognitive decline
timeFrame: at 48wks
Secondary outcomes:
measure: changes of cognitive decline
timeFrame: baseline, 24 wks, 48 wks, 72 wks
measure: changes of Parkinson's disease motor scale
timeFrame: baseline, 24 wks, 48 wks, 72wks
measure: Brain structure (cortical thickness and subcortical volume/shape) and Default mode network
timeFrame: 48wks
measure: brain functional connectivity
timeFrame: 48wks
measure: Comprehensive neuropsychological test
timeFrame: 48wks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT03850886: Nicotinamide in Non-Alcoholic Fatty Liver Disease Patients
Official title: Evaluation of Efficacy and Safety of Nicotinamide in Non-Alcoholic Fatty Liver Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Alcoholic Fatty Liver Disease
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy and safety of Niacinamide supplementation on clinical outcome of fatty liver patients having type II DM through measurement of the following before and after Niacinamide administration: Liver enzymes, Lipid profie, HOMA-IR, Oxidative stress markers and endothelial dysfunction marker. Fibroscan with CAP will be done at baseline and at the end of the trial. Also, Evaluation of quality of life of patients before and after Niacinamide administration using Chronic Liver Disease questionnaire.


Eligibility criteria: Inclusion Criteria:

* 1. Male or female outpatients age 18 to 70 years old. 2. The diagnosis of NAFLD will be established according to the appearance of fatty liver on US or elevated liver enzymes (\>1.5 times normal level).

Exclusion Criteria:

* 1. History of alcohol abuse (as defined by an average daily consumption of alcohol \> 30 g/day in men and \> 20 g/day in women).

  2. Cirrhotic patients.
* Fibroscan result \> 12Kpa or as
* predicted from FIB 4 score \> 3.25

FIB-4 = age (yr) \* AST (IU/L)/platelet count (109/L) \* ALT1/2 (IU/L) 3. Hyper / hypoparathyroidism. 4. Cancer. 5. Viral hepatitis. 6. Biliary disease. 7. Autoimmune hepatitis 8. Other causes of liver disease (hemochromatosis, Wilson's disease). 9. Participants who took antibiotics, probiotic supplements and/or hepatotoxic medicines (NSAIDs, Amiodarone and methotrexate) within 6 months before the start of the study and during the study.

10. Ascetic patients and congestive heart failure patients will be excluded due to unreliability of Fibroscan results in them.

11. Pregnancy and lactation.

Primary outcomes:
measure: Steatosis using Fibroscan with CAP
timeFrame: 3 months
measure: Adiponectin mesurement
timeFrame: 3 months
Secondary outcomes:
measure: Malondialdehyde
timeFrame: 3 monthes
measure: HOMA-IR
timeFrame: 3 months
measure: ALT, AST
timeFrame: 3 months
measure: LDL, cholesterol
timeFrame: 3 months
Other outcomes:
measure: Chronic Liver Disease Questionnaire
timeFrame: 3 months
Locations:
city: Cairo
country: Egypt
facility: AlZahraa hospital
Study officials:
References:
citation: El-Kady RR, Ali AK, El Wakeel LM, Sabri NA, Shawki MA. Nicotinamide supplementation in diabetic nonalcoholic fatty liver disease patients: randomized controlled trial. Ther Adv Chronic Dis. 2022 Feb 23;13:20406223221077958. doi: 10.1177/20406223221077958. eCollection 2022.
Clinical trial NCT04929886: Descriptive and Risk Factors Analysis of All-cause Postoperative Death in Patients Undergoing Elective Surgery
Official title: Descriptive and Risk Factors Analysis of All-cause Postoperative Death in Patients Undergoing Emergency Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Death
Keywords: Postoperative death
Elective surgery
Prediction model
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC
name: Henan Provincial People's Hospital
name: Xiangya Hospital
name: Shanxi Bethune Hospital
First posted: 2021-06-18
Enrollment: 1000000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients Undergoing Emergency Surgery

Brief summary: The investigators are aimed to develop and externally validate a prediction model of clinical risk factors that quantifies postoperative death after elective surgery.

We identify all patients treated with elective surgery, between 2000 and 2020, within the Wuhan Union hospital and all collaborators. The surgical patient cohort will be matched with the National Death database to determine the patient's postoperative death data.

60% patients were randomly selected to the development cohort. Logistic regression analysis for prediction of postoperative death adjusted for different covariates. The model was externally validated in the remaining 40% patients.


Eligibility criteria: Inclusion Criteria:

* Patients Undergoing Elective Surgery

Exclusion Criteria:

* Patients with incomplete electronic medical record information

Primary outcomes:
measure: Postoperative Death
timeFrame: The mortality within 5 years after the elective surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention
state: Beijing
city: Zhengzhou
country: China
facility: Henan People's Hospital, Henan, China
state: Henan
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital, Hunan, China
state: Hunan
city: Taiyuan
country: China
facility: Shanxi Bethune hospital, Shanxi, China
state: Shanxi
Study officials:
References:
Clinical trial NCT01440686: Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers
Official title: A Dose Block-randomized, Double-blinded, Placebo-controlled, Single-dose, Dose-escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of HL-032 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Growth Hormone Deficiency
Keywords: Pharmacokinetics
Pharmacodynamics
Safety
Male
Lead sponsor: HanAll BioPharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-09-26
Enrollment: 40
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of HL-032 after oral administration in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects
* Age(yr)between 19 and 50
* Signed written informed consent

Exclusion Criteria:

* Known hypersensitivity to Octreotide or hGH(human growth hormone)
* History of Cardiovascular, Respiratory, Renal/Genitourinary, Gastrointestinal, Neurological/Psychic, cancer
* Alcoholic, smokers or drug abusers
* Other conditions which in the opinion of the investigator preclude enrollment into the study

Primary outcomes:
measure: Area under the serum hGH(human growth hormone)concentration-time curve
timeFrame: From 0 to the time of the last quantifiable concentration over a 32-hour sampling period
measure: Maximum observed serum hGH concentration
timeFrame: Over a 32-hour sampling period
Secondary outcomes:
measure: Area under the effect(IGF-1, IGFBP-3, NEFA)curve
timeFrame: From time 0 to the time of the last concentration(AUECO-t) over 32-hour sampling period
measure: Maximum IGF-1, IGFBP-3, NEFA effect
timeFrame: Over a 32-hour sampling period
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute
Study officials:
affiliation: Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute
name: Kyung-Sang Yu, Medicine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01696786: Oocyte Cryopreservation
Official title: Oocyte Cryopreservation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertility Preservation
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2012-10-01
Enrollment: 250
Sex: FEMALE
Maximum age (years): 42
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The specific aim of this study is to further develop methods of oocyte cryopreservation and evaluate their impact on reproductive outcomes.


Eligibility criteria: Inclusion Criteria:

Any consenting female who wishes to freeze unfertilized oocytes and are:

1. at risk for ovarian hyperstimulation syndrome (enlarged ovaries with abdominal fluid accumulation) and postponement of pregnancy has been recommended.
2. a cancer patient anticipating treatment and have been cleared by the oncologists for ovarian stimulation.
3. a female who seeks to preserve her future fertility and does not wish to use donor or partner sperm to fertilize her eggs.
4. a donor egg recipient who elects to have some of the eggs obtained fertilized with husband/partner sperm and the rest cryopreserved for future use.
5. a patient for whom the partner's sperm retrieval or production has failed and donor sperm is not an option.
6. a patient who, for religious or ethical reasons, wants to limit the number of fresh oocytes exposed to sperm (fertilization) and do not want to either discard or donate the excess oocytes.

AND

1. has been clinically and psychologically approved for ovarian stimulation
2. age between 12 and 42 years, inclusive, at time of informed consent.
3. willing and able to comply with the protocol.
4. willing to provide follow-up information from her OB/GYN of any CVS/amniocentesis results, as well as information on obstetrical outcome.
5. agree to undergo intracytoplasmic sperm injection (ICSI) when oocytes are thawed.

For cancer patients:

1. No significant ovarian pathology as judged by physical exam and radiological studies;
2. Patient's general condition and prognosis deemed favorable for surgery and chemo/radio therapy;
3. No other major medical illness,
4. Oncologist approval for the ovarian stimulation and egg retrieval.

Exclusion Criteria:

Age \> 42 Subjects who do not meet the inclusion criteria will be ineligible for participation in this study.

Primary outcomes:
measure: Survival rate of cryopreserved oocytes with each cryopreservation method
timeFrame: 1 year
measure: Pregnancy rate following thawing/warming of oocytes
timeFrame: 1 year
measure: Implantation rate per embryo transferred
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
References:
Clinical trial NCT04528186: The Effect of Healthy Eating Index on Maternal Thyroid Volume in Hyperemesis Gravidarum
Official title: The Effect of Healthy Eating Index on Maternal Thyroid Volume in Hyperemesis Gravidarum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Diet
Thyroid Hypertrophy
Pregnancy Emesis
Keywords: Thyroid volume
, Healty eating index
, Pregnancy
Lead sponsor: Batman Training and Research Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Baskent University
First posted: 2020-08-27
Enrollment: 150
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women between the ages of 15-49 who apply to our hospital

Brief summary: The relationship between healthy eating index and maternal thyroid volume in patients with hyperemesis gravidarum is planned.

Detailed description: In pregnant women(11-14 week) admitted to our hospital between the ages of 15-49; After the healthy eating index scores were made face to face by the dietician, it was planned to measure the maternal thyroid volume by the radiologist.Our hypothesis in our study is to determine whether healthy eating index has effects on thyroid volume and blood parameters.

Eligibility criteria: Inclusion Criteria:

* 15-49 years old pregnant women
* 11-14 Gestational week of pregnancy
* Do not use medication,
* have no history of illness,
* who participated in face-to-face meetings with a dietician,
* who want to be included in the study,
* No smoking or alcohol consumption
* Patients with a BMI between 15-25

Exclusion Criteria:

* Pregnant women who are not between 15-49 years old,
* patients with chronic disease such as heart disease, diabetes,
* Patients who do not agree to meet with a dietician, patients who do not agree to be included in the study,
* smoking and alcohol use --Morbid-obese patients (BMI greater than 25)

Primary outcomes:
measure: Impact on Maternal Thyroid volume measures
timeFrame: 11-14 gestational week of pregnancy,Healty eating index scoresLow than 60 vs Higher than 60)
Secondary outcomes:
measure: Ketonuria, Notrophil / platelet ratio, TSH / ft3 ratio
timeFrame: 11-14 gestational week of pregnancy
Other outcomes:
Locations:
city: Batman
country: Turkey
facility: Batman Maternity and Child Health Hospital
Study officials:
affiliation: Batman Maternity and Child Health Hospital
name: Erhan Okuyan
role: PRINCIPAL_INVESTIGATOR
References: