louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01593631: Acid Lactase in Combination With Yoghurt Bacteria for Improvement of Lactose Digestion in Lactose Malabsorbers
Official title: A Combination of Yoghurt Bacteria and Acid Lactase From Aspergillus Oryzae Improves Lactose Digestion in Lactose Malabsorbers More Reliably Than Preparations Containing Acid Lactase or Yoghurt Bacteria Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lactose Malabsorption
Keywords: lactose malabsorption
lactose intolerance
lactose digestion
lactose maldigestion
acid lactase
yoghurt bacteria
Lead sponsor: Vitacare Gmbh & Co. KG
Sponsor class: INDUSTRY
First posted: 2012-05-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Fermented dairy products, especially real Yoghurt, are often tolerated better by lactose malabsorbers than unfermented dairy products. The intake of dietary supplements containing acid Lactase derived from Aspergillus oryzae with lactose containing foodstuffs is known to reduce/alleviate symptoms of lactose intolerance in lactose malabsorbers. The study aims to compare the effect of the intake of a combination of yoghurt bacteria and acid lactase to the effect of yogurt bacteria or acid lactase alone on the lactose digestion in lactose malabsorbers. It is hypothized that the combination preparation will be more effective and/or will show a more reliable effect than the two mono-preparations.


Eligibility criteria: Inclusion Criteria:

* Subjects of African or Asian origin.
* Older than 18 years
* Written informed consent

Exclusion Criteria:

* Participation in a clinical study with a drug or a medical product withing the last 30 days;
* Inability to comply with the study protocol;
* Allergy to milk protein;
* Intolerance against lactase preparations;
* Known metabolic or gastrointestinal diseases which affect the absorption, metabolism or excretion of food components except lactose maldigestion;
* Intake of drugs influencing resorption of food components or gastrointestinal motility;
* Surgery within the last three months which still affect the current status of health;
* Psychiatric diseases
* Epilepsia
* Risk for suicide
* Eating disorders, e.g. anorexia, bulimia
* Alcohol or drug abuse
* Legal incapacity

Primary outcomes:
measure: Increase in hydrogen concentration in the breath (H2-exhalation breath test)
timeFrame: Every 20 minutes for 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: tecura GmbH Medicine & Biotechnics - Dept. of Clinical Research
state: Schleswig-Holstein
Study officials:
References:
citation: de Vrese M, Laue C, Offick B, Soeth E, Repenning F, Thoss A, Schrezenmeir J. A combination of acid lactase from Aspergillus oryzae and yogurt bacteria improves lactose digestion in lactose maldigesters synergistically: A randomized, controlled, double-blind cross-over trial. Clin Nutr. 2015 Jun;34(3):394-9. doi: 10.1016/j.clnu.2014.06.012. Epub 2014 Jul 8.
Clinical trial NCT00427531: Skin Conduction Device and Patient Diary for Measuring Hot Flashes in Postmenopausal Women With Hot Flashes
Official title: An Exploratory Trial to Examine the Accuracy of Various Hot Flash Variables With an Ambulatory Sternal Skin Conductance Recording Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hot Flashes
Keywords: hot flashes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-01-29
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: RATIONALE: Measuring how often hot flashes occur in postmenopausal women may be done by using a skin conduction device or by using a diary.

PURPOSE: This clinical trial is studying a skin conduction device and a patient diary for measuring hot flashes in postmenopausal women with hot flashes.

Detailed description: OBJECTIVES:

* Determine the differences in frequency, severity, and duration of hot flash activity using an ambulatory sternal skin conductance recording tool and patient hot flash diary in postmenopausal women with hot flashes.
* Assess the recordings made by an ambulatory sternal skin conductance measuring and recording tool during a 30-minute exercise period in these patients.

OUTLINE: Patients wear an ambulatory sternal skin conductance hot flash device continuously for 24 hours.

Patients complete hot flash diaries over 24 hours. Patients undergo treadmill exercise over 30 minutes and record hot flash activity using the skin conductance device during 10 minutes of sweating. Patients also complete the Comfort, Bother, and Weight Questionnaire at the completion of the study.

PROJECTED ACCRUAL: A total of 3 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of bothersome hot flashes, defined by their occurrence ≥ 4 times/day

  * Daily hot flashes that have been present for ≥ 1 month

PATIENT CHARACTERISTICS:

* Female
* Postmenopausal
* ECOG performance status 0-1
* No history of allergic or other adverse reactions to adhesives
* No other medical condition known to cause sweating and/or flushing
* No implanted pacemakers or metal implants
* No reliance on electronic devices for regular monitoring (i.e., insulin pumps or blood pressure monitors)

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Differences in frequency, severity, and duration of hot flash activity using an ambulatory sternal skin conductance recording tool and patient hot flash diary
measure: Hot flash recordings as measured by an ambulatory sternal skin conductance measuring and recording tool during a 30-minute exercise period
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Debra L. Barton, R.N., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT07010731: Level of Social Support and Associated Factors Among Diabetic Patients in Bahir Dar City Public Hospitals, Amhara Regional State, North West Ethiopia, 2023
Official title: Level of Social Support and Associated Factors Among Diabetic Patients in Bahir Dar City Public Hospitals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Social Support and Associated Factors Among Diabetic Patients
Keywords: social support, diabetes mellitus, family support, support system
Lead sponsor: Debre Berhan University
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All adult diabetic patients were considered to be the source population

Brief summary: Supplementary: English version of the questioner PART 1- Questions Related to Socio-economic Characteristics Identification No.__________________ No. Question circle the appropriate option 100 Gender of the respondent? 1. Male 2. Female 101 What is the age of the respondent? Age in years _______ (yy) 102 Residence 1. Urban 2. Rural 103 What is the educational status of the respondent? 1. no formal education 2. Grade1-8 3. Grade 9-12 4. College \& above

104 monthly income of the Respondent _______ ETB 105 marital status 1. Married 2. Single 3. Widowed 4. Divorced 106 Do have health insurance 1. Yes 2. no

107 Occupation 1.Private business 2.Government employee 3.Private employee 4.other

PART 4: Clinical parameter 200 Types of diabetes 1. Type 1 2. Type 2 201 Type of current diabetic treatment 1. Insulin 2. Oral drug 3. Both 202 Duration of DM after first diagnosis. 1. \< 5 years 3. \>10years 2. 5-10 years 203 Comorbid status 1.Yes if specify ----------- 2.no 204 Blood glucose level 1______,2_________,3¬¬_______mg/dl

Part 3 Oslo social support scale (OSSS-3) S.no Question Response 300 How many people are so close to you that you can count on them if you have great personal problems? 1 'none' 2 '1-2' 3 '3-5' 4 '5+' 301 How much interest and concern do people show in what you do? 1 'none' 2 'little' 3 'uncertain' 4 'some' 5 'a lot' 302 How easy is it to get practical help from neighbors if you should need 1 'very difficult' 2 'difficult' 3 'possible' 4 easy 5 very easy


Eligibility criteria: Inclusion Criteria:The study population was a diabetic patient with a follow-up who fulfilled the eligibility criteria -

Exclusion Criteria:Those patients who are critically ill and those less than 18 years old was excluded because they couldn't provide adequate information related to the study.

-

Primary outcomes:
measure: Level of social support and associated factors among diabetic patients in Bahir Dar city public hospitals, Amhara regional state, North West Ethiopia, 2023.
timeFrame: March 20 to April 20, 2023 GC
Secondary outcomes:
Other outcomes:
Locations:
city: Bahir Dar
country: Ethiopia
facility: Bahir Dar city public hospitals
Study officials:
References:
Clinical trial NCT02173431: Recognize High Pressure Areas in Human Body to Prevent Decubitus Ulcers
Official title: Mapping Pressure of Human Body to Prevent Bedsores
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pressure Ulcer Stage 1
Keywords: BMI
Pressure
Bedsore
Lead sponsor: Assuta Medical Center
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from 18 y.o. before elective operation will be recruited for the study/ Any patient will be enroled in each group' seven in total according the BMI.

Brief summary: Prolonged external pressure to the tissue leads to compression, ischemia and development of pressure ulcer.

Underweight seems to be associated with high pressure ulcer risk but the distinct relation between overweight and pressure ulcer development is uncertain.

Bedsores are caused by pressure against the skin that limits blood flow to the skin and nearby tissue.

Others factors related to limited mobility can make the skin vulnerable to damage and contribute to the development of pressure sores. Three primary contributing factors are sustained pressure, friction and shear.

Bedsores are easier to prevent than to treat.

Detailed description: * age
* weight
* high
* BMI
* pressure scanning map
* Alimentary status
* Diseases

Eligibility criteria: Inclusion Criteria:

* Any patient admitted for elective surgery,
* Patients above 18 y.o.,
* Patient admitted for surgery that required 3 or more days in hospital

Exclusion Criteria:

* Patients under 18
* Patients that require emergency surgery
* Patients that have bedsores before admission

Primary outcomes:
measure: Mapping body pressure
timeFrame: up to 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: ASSUTAMC
Study officials:
affiliation: ASSUTA MC
name: Sergio G Susmallian, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00151931: Efficacy and Tolerability of Treatment With Lanthanum Carbonate in Patients With End Stage Renal Disease Receiving Dialysis
Official title: A Multi-Centre, Open-Label Study Assessing the Efficacy and Tolerability of Lanthanum Carbonate in the Reduction of Serum Phosphate Levels in End Stage Renal Disease Patients Receiving Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Failure, Chronic
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 456
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with lanthanum carbonate


Eligibility criteria: Inclusion Criteria:

* Males and females of childbearing potential agree to take adequate precautions to prevent contraception
* Patients diagnosed with ESRD must have been receiving a stable dialysis regimen for chronic renal failure for the 2 consecutive months prior to enrollment in the study
* Patient requires treatment for hyperphosphataemia

Exclusion Criteria:

* Pregnant or lactating women
* Patients who continue to require treatment with compounds containing calcium, aluminum or magnesium
* Patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma
* Patients who are HIV+
* Patients with any significant gastrointestinal surgery or disorders

Primary outcomes:
measure: Change in pre-dialysis serum phosphate levels at Week 3 compared with Week 5
timeFrame: Week 3 and Week 5
Secondary outcomes:
measure: Treatment emergent adverse events
timeFrame: Throughout the study period of approximately 20 months.
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Hutchison AJ, Laville M; SPD405-313 Lanthanum Study Group. Switching to lanthanum carbonate monotherapy provides effective phosphate control with a low tablet burden. Nephrol Dial Transplant. 2008 Nov;23(11):3677-84. doi: 10.1093/ndt/gfn310. Epub 2008 Jun 24.
Clinical trial NCT06568731: A Study to Learn How Different Amounts of the Study Medicine Danuglipron Are Taken up Into the Blood in Otherwise Healthy Adults With Overweight or Obesity
Official title: A PHASE 1, OPEN- LABEL STUDY TO EVALUATE THE MULTIPLE DOSE PHARMACOKINETICS OF DANUGLIPRON FOLLOWING ORAL ADMINISTRATION IN OTHERWISE HEALTHY ADULT PARTICIPANTS WITH OVERWEIGHT OR OBESITY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: Overweight
Obesity
Danuglipron
GLP-1
Overtly healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-08-23
Enrollment: 23
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: The purpose of this study is to learn the following about the study medicine, danuglipron, after multiple days of dosing in healthy adults who are overweight or obese:

* how the study medicine, danuglipron, is taken up into the blood
* about the safety and tolerability of danuglipron

The total number of weeks of the study is about 15 (about 4 months).


Eligibility criteria: Key Inclusion Criteria:

* 18 years of age or older
* Body mass index (BMI) of ≥25.0-45.4 kg/m2; and a total body weight \>50 kg (110 lb)

Key Exclusion Criteria:

* Evidence or history of any clinically significant medical conditions or laboratory abnormality
* Any condition possibly affecting drug absorption
* Known intolerance/hypersensitivity to a GLP-1R agonist

Primary outcomes:
measure: Steady-state area under the concentration-time profile from time zero to 24 hours (AUC24) for danuglipron
timeFrame: Predose to 24 hours post danuglipron administration
measure: Steady-state maximum observed concentration (Cmax) for danuglipron
timeFrame: Predose to 24 hours post danuglipron administration
measure: Steady-state time to reach maximum observed concentration (Tmax) for danuglipron
timeFrame: Predose to 24 hours post danuglipron administration
Secondary outcomes:
measure: Number of participants reporting Treatment Emergent Adverse Events (TEAEs)
timeFrame: From baseline up to 28-35 days post last dose taken
measure: Number of participants reporting clinically significant clinical laboratory abnormalities
timeFrame: From baseline up to 28-35 days post last dose taken
measure: Number of participants reporting clinically significant vital sign abnormalities
timeFrame: From baseline up to 28-35 days post last dose taken
measure: Change from baseline in body weight
timeFrame: From baseline up to 28-35 days post last dose taken
measure: Number of participants reporting clinically significant changes ECG abnormalities
timeFrame: From baseline up to 28-35 days post last dose taken
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Clinical Research Unit - New Haven
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00643331: The Effect of Exercise in Postmenopausal Women with Low Bone Density
Official title: The Effect of Exercise in Postmenopausal Women with Low Bone Density
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis
Osteopenia
Keywords: Osteoporosis
Exercise
Low bone density
Falls
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: Swisse Vitamins Pty Ltd
First posted: 2008-03-26
Enrollment: 38
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial aims to evaluate the effects of a 12 month gym- and home-based exercise program on bone density and falls risk factors in postmenopausal women with low bone density. It is hypothesised that the exercise program will lead to improvements in bone density and falls risk factors such as balance and muscle strength compared with usual care.


Eligibility criteria: Inclusion Criteria:

* Be aged greater than 50 years
* Be at least 5 years post menopause (defined as the last normal menstrual bleed)
* Have osteopenia of the hip defined as a DXA T-score between -1 and -2.5 in one or more regions of the proximal femur (total hip, neck or trochanter regions).
* Have primary osteopenia
* Be community dwelling (not in residential care)
* Be able to attend an exercise program 3 times per week over the 12-month period
* Be able to read and write English

Exclusion Criteria:

* Secondary causes of bone loss such as osteomalacia, glucocorticoid medication
* Co-morbidities that would interfere with participation in exercise such as severe heart or pulmonary disease, inflammatory joint disease, severe osteoarthritis, psychiatric condition
* Physical or orthopaedic disabilities that would place the subject at risk or limit their ability to perform exercise
* Spinal osteoporosis defined as DXA T-score \<-2.5
* A past vertebral fracture
* Body mass index \> 35 or \< 18.
* Currently on hormone replacement therapy (HRT)
* Current smoker
* Past use of HRT within the past 3 years and for more than 6 months duration
* Taking medication known to affect bone including oestrogen or steroid hormones
* Known clinically significant liver or renal disease
* Cancer within the past 5 years
* Doing regular strength training and/or weight-bearing exercise at least once per week in past 6 months
* Unlikely to comply with the intervention protocol

Primary outcomes:
measure: Bone density measured using DXA at the lumbar spine and proximal femur
timeFrame: 12 months
Secondary outcomes:
measure: Falls risk factors
timeFrame: 12 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: University of Melbourne
state: Victoria
Study officials:
affiliation: University of Melbourne
name: Kim L Bennell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03186131: Efficacy of Oral Ibandronate in Osteoporosis
Official title: Examination of Bone Metabolism and Bone Mineral Density in Primary and Secondary Osteoporosis Treated by Oral Ibandronate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Osteoporosis
Lead sponsor: Shinshu University
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There has been no comparative data between oral ibandronate and oral ibandronate plus active vitamin D


Eligibility criteria: Inclusion Criteria:

* Osteoporotic patients who want to take oral ibandronate

Exclusion Criteria:

* Patients who are allergic to oral ibandronate or vitamin D Patients who have not taken oral ibandronate for the last 2 years

Primary outcomes:
measure: Bone mineral density
timeFrame: Change from Baseline Values at 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Matsumoto
country: Japan
facility: Yukio Nakamura
state: Nagano
Study officials:
References:
Clinical trial NCT01614431: N Acetyl Cysteine for Cystinosis Patients
Official title: N Acetyl Cysteine Can Decrease the Progression of Renal Disease in Cystinosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Disease
Cystinosis
Keywords: renal function
before and after N acetyl cysteine
Cystinosis patients
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2012-06-08
Enrollment: 23
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study intends to verify the interference of N acetyl cysteine in the progression of chronic kidney disease in patients with Nephropathic Cystinosis.

Detailed description: Patients with Nephropathic Cystinosis have an increased oxidative stress and go to end-stage renal disease, even when all steps of the treatment are done. Therefore, this study is conducted to verify the interference of the stress oxidative in the progression of the renal disease with the use of an oxidant drug, N acetyl cysteine (NAC). The investigators selected patients with good compliance of the treatment. In these patients the investigators evaluate the serum creatinine, creatinine clearance estimated by Schwartz Formula, cystatin C and a marker of oxidative stress, TBARS ( thiobarbituric acid substances). The variables are analyzed 6 months before the introduction of NAC and the three months after NAC.

Eligibility criteria: Inclusion Criteria:

* cystinosis patients age under 18 years with good compliance to the treatment with Chronic Kidney Disease 1 to 4 according to KDOQI

Exclusion Criteria:

* patients with CKD stage 5

Primary outcomes:
measure: creatinine clearance
timeFrame: change in creatinine clearance evaluated 6 months before , at baseline and after 3 months with NAC
measure: cystatin c
timeFrame: change in cystatin C from baseline and after 3 months with NAC
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Maria Helena Vaisbich, Doctor
role: PRINCIPAL_INVESTIGATOR
References: