louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02418130: A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of 'Ursa Complex Soft Cap. (UDCA-004)' in Patients With Physical Fatigue.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fatigue
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2015-04-16
Enrollment: 166
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of 'Ursa Complex Soft Cap. (UDCA-004)' in patients with physical fatigue.


Eligibility criteria: Inclusion Criteria:

* CIS greater than or equal to 76, HADS less than or equal to 10

Exclusion Criteria:

* Subjects who have diseases that can cause fatigue
* Subjects who are taking medication that can cause fatigue

Primary outcomes:
measure: Rate of subjects whose CIS score has improved under 76 at week 4
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
References:
Clinical trial NCT05536830: Assessment of DeMentia Nutrition Intervention Needs Among Care Recipients and carEgivers
Official title: Assessment of DeMentia Nutrition Intervention Needs Among Care Recipients and carEgivers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Keywords: nutrition assessment
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited as caregiver-patient dyads, and both must fit the inclusion and exclusion criteria.

Brief summary: Nutrition is critical for disease prevention and brain health. Malnutrition and weight loss often affect persons with Alzheimer's dementia (PWD), worsening overall health and dementia. Informal caregivers (usually family members) perform many nutrition-related tasks as part of daily care such as food preparation and feeding. Limited research, however, suggests informal caregivers experience high rates of caregiver burden, malnutrition and low health literacy. More research is needed to uncover these and other factors that may contribute to malnutrition for both PWDs and their caregivers. Nutrition literacy, or ability to navigate nutrition information to select healthy food, may be an important caregiving factor that protects both individuals from experiencing nutritional decline. Although the NIH has increased funding to support caregiver research, caregiver interventions that include nutrition are lacking. The purpose of this study is to inform the design of a future nutrition intervention study.


Eligibility criteria: Inclusion Criteria:

* Person with dementia: Must be an adult of any age, diagnosed with Alzheimer's dementia or other dementia, reside at home with a family caregiver or domestic partner, and have weight records at a minimum of 2 timepoints.
* Caregiver: Must be at least 18 years old, English speaking, primary caregiver who is responsible for food planning, and no overt cognitive impairment.

Exclusion Criteria:

* Person with dementia: Frontal-temporal dementia, alcohol-related dementia, Huntington's disease, schizophrenia, manic-depressive disorder, or actively participating in nutrition intervention research.
* Caregiver: Visual impairments that prevent completing questionnaires or actively participating in nutrition intervention research.

Primary outcomes:
measure: Nutrition status of persons with dementia
timeFrame: 1 month
measure: Nutrition literacy of caregivers
timeFrame: 1 week
measure: Nutrition status of caregivers
timeFrame: 1 month
Secondary outcomes:
measure: Perceived nutrition needs of informal caregivers of persons with dementia
timeFrame: 1 week
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: Heather D Gibbs, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04317430: Niclosamide Role in Diabetic Nephropathy
Official title: Possible Role of Niclosamide in Patients With Diabetic Kidney Disease: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Nephropathies
Keywords: Diabetes - Niclosamide - Diabetic kidney disease
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-03-23
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: This study is randomized, controlled, parallel, prospective clinical study will be conducted on 60 patients diagnosed with type 2 diabetes mellitus at least five years ago. Patients will be recruited from Tanta University Hospital, Tanta, Egypt.

Accepted patients will be randomized into 2 groups as the following:

Control group: 30 patients will receive maximum tolerated dose of ACEI plus placebo pills for six months Treatment group: 30 patients will receive maximum tolerated dose of ACEI plus niclosamide tablets 1 gram once daily for six months The primary end point will be the change in Urinary albumin to creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) after six months of treatment


Eligibility criteria: Inclusion Criteria:

* Patients with Type 2 diabetes mellitus at least 5 years ago
* Stage 2 and 3 diabetic nephropathy (persistent micro- or macroalbuminuria with urinary albumin creatinine ratio (UACR) \>30mg/g) despite treatment with maximum tolerated dose of ACE inhibitors for at least 8 weeks prior to the screening
* Hemoglobin A1c \> 6.5 % with regular use of insulin and/or oral glucose lowering agents

Exclusion Criteria:

* Type 1 diabetes mellitus
* Severe renal impairment (eGFR\< 30 mL/min/1.73 m2 at screening)
* Pregnant or lactating women
* Chronic heart failure
* Inflammatory or autoimmune disease
* History of kidney disease other than diabetic nephropathy

Primary outcomes:
measure: Change in urinary albumin creatinine ratio (UACR)
timeFrame: 6 months
measure: Estimated glomerular filtration rate (eGFR)
timeFrame: After 6 months
Secondary outcomes:
measure: Change of Urinary matrix metalloproteinase-7 (MMP-7) level
timeFrame: 6 months
measure: Change of Urinary podocalyxin level
timeFrame: 6 months
Other outcomes:
measure: Change of Urinary 8-hydroxy-2' -deoxyguanosine (8-OHdG) level
timeFrame: 6 months
Locations:
city: Tanta
country: Egypt
facility: Faculty of Pharmacy, Tanta University
Study officials:
References:
Clinical trial NCT04932330: Risk Factors of ICU-acquired Weakness
Official title: ICU-acquired Weakness in Extracorporeal Membrane Oxygenation Support: Frequency and Risk Factors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ICU Acquired Weakness
Keywords: ICU Acquired Weakness
Extracorporeal Membrane Oxygenation
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 85
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: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: There were 85 patients used extracorporeal membrane oxygenationbetween March 2017 to March 2020. Among the 85 patients, 22 patients presented exclusion criteria and 63 patients were included in the final analysis.

Brief summary: We conducted a retrospective study of critical ill patients who used ECMO during their ICU stay. ICU-AW was diagnosed at the time when patients discharged and had a Medical Research Council (MRC) sum score \< 48 out of a maximal score of 60. We divided patients to ICU-acquired weakness group and no ICU-acquired weakness group and compared their clinical characteristics. Baseline characteristics and therapy details were collected from the case report forms and inspection reports. Univariable analysis and logistic regression analysis were used to analyze clinical characteristics of individuals and to find risk factors of ICU-AW.


Eligibility criteria: Inclusion Criteria:

* Critical ill patients who used extracorporeal membrane oxygenation during their ICU stay. Patients were recruited from the general ICU of the second affiliated hospital of Zhejiang University, between March 2017 to March 2020.

Exclusion Criteria:

* Patients who was less than 18 years old, had been proven or suspected neurological impairment, using extracorporeal membrane oxygenation less than 24 hours, severe head or spinal cord injury and pregnant woman.

Primary outcomes:
measure: Differences between ICU-acquired weakness in patients receiving extracorporeal membrane oxygenation support
timeFrame: 1 day
Secondary outcomes:
measure: Frequency of ICU-acquired weakness in in patients receiving extracorporeal membrane oxygenation support
timeFrame: 1 day
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Xinyi Chen
state: Please Select
Study officials:
References:
Clinical trial NCT02501330: Safety And Efficacy Of Bosutinib
Official title: DRUG USE INVESTIGATION OF BOSUTINIB FOR CML (POST MARKETING COMMITMENT PLAN)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Myelogenous Leukemia
Keywords: Drug use investigation in Japan
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-07-17
Enrollment: 702
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients who have been treated with Bosutinib

Brief summary: The objective of this surveillance is to collect information about

1. adverse drug reaction not expected from the LPD (unknown adverse drug reaction)
2. the incidence of adverse drug reactions in this surveillance
3. factors considered to affect the safety and/or efficacy of this drug.

Detailed description: The patients should be registered by central registration system.

Eligibility criteria: Inclusion Criteria:

* Chronic myelogenous leukemia patients resistant or intolerant to prior treatment there is no experience with this drug
* Newly-diagnosed chronic phase Chronic myelogenous leukemia patients there is no experience with this drug

Exclusion Criteria:

* Patients with a history of hypersensitivity
* Women who may possibly be pregnant or become pregnant

Primary outcomes:
measure: The incidence of adverse drug reactions
timeFrame: 24 weeks
measure: Cytogenetic response
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shibuya-ku
country: Japan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06298630: Long-term Follow-up Study of BRL-101 for TDT
Official title: Long-term Follow-up Study of BRL-101 in the Treatment of Transfusion-dependent β-thalassemia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Thalassemia, Beta
Lead sponsor: Bioray Laboratories
Sponsor class: INDUSTRY
Collaborators: name: First Affiliated Hospital of Guangxi Medical University
name: Xiangya Hospital of Central South University
name: Chinese Academy of Medical Sciences
name: Nanfang Hospital, Southern Medical University
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army
name: Shenzhen Children 's Hospital
First posted: 2024-03-07
Enrollment: 45
Sex: ALL
Minimum age (years): 3
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with transfusion-dependent β-thalassemia who have been treated with BRL-101.

Brief summary: Observe long-term safety risk and long-term efficacy after intravenous infusion of BRL-101 in TDT subjects.

Detailed description: Observe long-term delayed safety risks such as emerging neoplasms, emerging haematological disorders, and long-term efficacy after intravenous infusion of BRL-101 in TDT subjects.

Eligibility criteria: Inclusion Criteria:

1. Provision of written informed consent for this study by subjects, or as applicable, subject's parent(s)/legal guardian(s)
2. Treated with BRL-101 for therapy of transfusion-dependent β-thalassemia.

Exclusion Criteria:

- There are no exclusion criteria for this study

Primary outcomes:
measure: Incidence of hematologic malignancies
timeFrame: Up to 15 years post-drug product infusion
measure: Frequency, grade, and relationship of SAEs
timeFrame: Within 2 years to 5years after BRL-101 Infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Children 's Hospital
state: Guangdong
city: Nanning
country: China
facility: No. 923 Hospital of Joint Support Force of Chinese People 's Liberation Army Hospital
state: Guangxi
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Tianjin
country: China
facility: Tianjin Institute of Hematology
state: Tianjin
city: Guangxi
country: China
facility: The First Affiliated Hospital of GUANGXI MEDICAL UNIVERSITY
Study officials:
affiliation: Bioray Laboratories
name: Xiaochen Wang
role: STUDY_CHAIR
References:
Clinical trial NCT02813330: Subcutaneous Sterile Water Injection for Relief of Low Back Pain
Official title: Subcutaneous Sterile Water Injection for Relief of Low Back Pain During Normal Labor: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Low Back Pain
Keywords: Women
severe
low back ache
labor
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 336
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To compare the effect of subcutenous sterile water injection technique with the subcutaneous saline injection technique in the degree and duration of low back pain-relieving during childbirth

Detailed description: Study sample:

The convenience sample will be recruited randomly on the basic of odd number will have saline injection and even number will be given a placebo (Sterile water injection)

Setting:

Labor ward in Women's health center at Assiut university hospital

Study design:

Experimental Randomized control study

Sample size:

The sample size was calculated using the formula N= (Zα+Zβ)2 x 2p(1-p)÷d2 ,taking the level of significance as 5%, Zα=1.96 and power of the test as 80%, Zβ=0.84. p=0.113. A sample size of 165 in each group was calculated. Total of 330 women will be studied (165 in each arm) Inclusion criteria

* In labour (spontaneous or induced
* During first stageof labour
* Primary and multiparous women
* A term singleton pregnancy (between 37 + 0 and 41 weeks)
* Have a fetus in a cephalic presentation
* Experience back pain assessed by visual analogue scale VAS and Face pain analogue ( Warden V, Hurley AC, Volicer L.2003)
* Provide informed consent.

Exclusion criteria

* Multiple pregnancy
* Malpresentation (breech, transverse, shoulder)
* Previous CS
* Infection or inflammation at the injection sites or complications that could cause bleeding at injection site eg. Thrombocytopenia.

Study Tools:

1. Personal data questionnaire
2. Visual Analogue Scale and Face analogue scale
3. Satisfaction scale

Eligibility criteria: Inclusion Criteria:

* In labour (spontaneous or induced record
* During first stage of labour
* Primary and multiparous women
* A term singleton pregnancy (between 37 + 0 and 41 weeks)
* Have a fetus in a cephalic presentation
* Experience back pain assessed by visual analogue scale VAS and Face pain analogue
* Provide informed consent.

Exclusion Criteria:

* Women with chronic disease
* Medical condition associated with pregnancy ( Pre-eclampsia- Eclampsia- Diabetic pregnancy.... etc)
* Complicated labor process ( obstructed, preterm labor, twins)

Primary outcomes:
measure: Pain relief
timeFrame: two hours for each client
measure: Women's Saisfaction
timeFrame: each 15 min until 120 min
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00366730: Study of Nitazoxanide in the Treatment of Amebiasis in Children
Official title: Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Entamoeba Histolytica in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Amebiasis
Keywords: Amebiasis
Entamoeba histolytica
Lead sponsor: Romark Laboratories L.C.
Sponsor class: INDUSTRY
First posted: 2006-08-21
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of nitazoxanide suspension in treating diarrhea caused by Entamoeba histolytica in children.


Eligibility criteria: Inclusion Criteria:

* Age 1 to 11 years.
* Patients with diarrhea (≥3 bowel movements/day) with one or more enteric symptoms such as bloody stools, rectal bleeding or enlarged colon.
* Positive stool ELISA test for Entamoeba histolytica within 7 days prior to enrollment.

Exclusion Criteria:

* Patients with identified causes of diarrhea other than E. histolytica.
* Use within 2 weeks of enrollment of any drug or therapy with possible anti-protozoal activity.
* Females who are pregnant, suspected of being pregnant or breastfeeding.
* Serious systemic disorders incompatible with the study.
* History of hypersensitivity to nitazoxanide.
* Patients in whom the possibility of receiving placebo and not being able to receive immediately an effective treatment will be incompatible with the severity of the patient's illness.
* Patients with amebic liver abscess.
* Patients known to have or suspected of having AIDS.
* Patient with immune deficiencies.

Primary outcomes:
measure: Resolution of clinical symptoms of amebiasis
Secondary outcomes:
measure: Eradication of cyst or trophozoites of E. histolytica from post-treatment stool samples
measure: Time from initiation of treatment to passage of last unformed stool
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: University Hospital
city: Benha
country: Egypt
facility: Benha University Hospital
Study officials:
affiliation: Benha University
name: Samir M Kabil, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Yehia El-Gohary, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00400530: Upper GI Handling of Branded vs. Generic Alendronate
Official title: A Randomized, Single-Blind Study to Evaluate Upper Gastrointestinal Handling of Branded Versus Generic Alendronate Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-11-17
Enrollment: 25
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare upper GI handling of fosamax and generic, because the main AE profile of alendronate is before systemic absorption in the esophagus; differences could be relevant to the side effect profile.


Eligibility criteria: Inclusion Criteria:

* Post-menopausal females aged greater 55 years
* Prescribed alendronate 70 mg tablets for a therapeutic indication throughout the previous 3 months and expected to continue on this treatment for the duration of the study
* Willing to abstain from alcohol for 24 hours before each dose and until the end of each study day
* Willing to abstain from smoking for 24 hours before each dose and until the end of each study day

Exclusion Criteria:

* History of drug hypersensitivity
* Suffers from dysphagia, achalasia, or other conditions or medications affecting upper gastrointestinal motility

Primary outcomes:
measure: Gamma camera imaging of tablet dissolution in oesophagus
Secondary outcomes:
measure: Gamma camera dissolution of tablets in stomach
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04463030: Antioxidant Bioavailability
Official title: Clinical Pilot Study on Antioxidant Uptake and Downstream Effects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pharmacokinetics
Lead sponsor: Natural Immune Systems Inc
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, placebo-controlled, single blind, cross-over trial
Primary purpose: BASIC_SCIENCE

Brief summary: A small cross-over trial on 3 different doses of liposomal vitamin C, comparing vitamin C uptake and downstream effects when 24 people consume 1, 2, and 5 grams on different test days, compared to placebo.

Detailed description: A randomized, cross-over study design will be used to evaluate the effects of consumption of 4 different doses of liposomal vitamin C (0, 1, 2, and 5 grams). The study is of 5 weeks' duration, with evaluation of a different dose at each of week 1, week 3 and week 5 with a one week washout between each dose.

Eligibility criteria: Inclusion Criteria:

* Adult people of either gender;
* BMI between 18.0 and 34.9 (inclusive);
* Willing to abstain from coffee, tea, and soft-drinks for at least one hour prior to a clinic visit;
* Willing to abstain from alcohol for at least 12 hours prior to a clinic visit;
* Willing to maintain a consistent habit of abstaining from exercising, tobacco use, and nutritional supplements on the morning of a study visit.

Exclusion Criteria:

* Cancer during past 12 months;
* Chemotherapy during past 12 months;
* Significant active uncontrolled illness (such as lymphoma, liver disease, kidney failure, heart failure).
* Previous major surgery to stomach or intestines \[(absorption of test product may be altered) minor surgery is not a problem, including appendix and gallbladder removal\];
* Currently taking nutritional supplements judged by the study coordinator to negate or camouflage the effects of the test product;
* Food allergies related to ingredients in test product;
* Women who are pregnant, nursing, or trying to become pregnant.

Primary outcomes:
measure: Evaluation of vitamin C levels
timeFrame: 6 hours
Secondary outcomes:
measure: Evaluation of antioxidant status
timeFrame: 6 hours
Other outcomes:
measure: Evaluation of downstream effects reflecting antioxidant protection
timeFrame: 6 hours
Locations:
city: Klamath Falls
country: United States
facility: Gitte Jensen
state: Oregon
Study officials:
affiliation: NIS Labs
name: Gitte Jensen, PhD
role: PRINCIPAL_INVESTIGATOR
References: