louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03484845: Lactoferrin Versus Ferrous Fumarate for Treatment of Mild to Moderate Iron Deficiency Anemia During Pregnancy
Official title: Lactoferrin Versus Ferrous Fumarate for Treatment of Mild to Moderate Iron Deficiency Anemia During Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Iron Deficiency Anemia of Pregnancy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 150
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will conducted to evaluate and comparison between the effectiveness, safety and acceptability of lactoferrin alone, ferrous fumarate alone and combination of both for the treatment of mild to moderate IDA during pregnancy.

Detailed description: Anemia in pregnancy is a major public health problem, where it has been estimated that 41.8% of pregnant women worldwide are anemic .

Iron deficiency anemia (IDA) is the condition in which there is anemia due to a lack of iron. IDA develops when available iron is insufficient to support normal red cell production and is the most common type of anemia Anemia has a significant impact on the health of the fetus as well as that of the mother. It impairs the oxygen delivery through the placenta to the fetus and interferes with the normal intrauterine growth, leading to fetal loss and perinatal deaths. Anemia is associated with increased preterm labor (28.2%), preeclampsia (31.2%), and maternal sepsis.

The daily requirement of iron is around 1.5 mg in nonpregnant women. This requirement increases dramatically during pregnancy to reach 6-7 mg/day (total 1000 mg) with advanced gestational age. Pregnancy causes a twofold to threefold increase in the requirement for iron and a 10- to 20-fold increase in folate requirement. The increase in demand for iron is mainly due to fetal requirement, placenta, blood volume, tissue accretion, and the intra-partum potential for blood loss

Eligibility criteria: Inclusion Criteria:

* Pregnant women from 24-36 weeks of gestation.
* Mild to moderate anemia.

Exclusion Criteria:

* Women with a history of anemia due to any other causes other than IDA.
* Severe anemia requiring blood transfusion.
* History of peptic ulcer.
* known hypersensitivity to iron preparations.

Primary outcomes:
measure: Increase in blood hemoglobin.
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04099745: Comparing the Accuracy of Different Blood Glucose Monitoring Systems (CGM and FGM)
Official title: Comparing the Accuracy of Different Blood Glucose Monitoring Systems (CGM and FGM) With Venous Blood Glucose
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: FGM
CGM
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To compare the accuracy of different blood glucose monitoring systems (CGM and FGM) in diabetic patients with insufficient islet function.

Detailed description: To compare the accuracy of different blood glucose monitoring systems (CGM and FGM) in diabetic patients with insufficient islet function with Venous Blood Glucose (including FGM early, middle and late, pre-and post-meal, high and low blood glucose).

Eligibility criteria: Inclusion Criteria:

* volunteer to participate and be able to sign informed consent prior to the trial.
* patients with type 2 diabetes or type 1 diabetes, aged 18-80 years old.
* No acute complications such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc.
* Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise.

Exclusion Criteria:

* Patients with insulin allergy.
* Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value; Serum creatinine was 1.3 times higher than the upper limit of normal.
* Drug abuse and alcohol dependence in the past 5 years.
* Systemic hormone therapy was used in the last three months.
* Patients with poor compliance and irregular diet and exercise.
* Patients with pregnancy, lactation or pregnancy intention.
* Any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.

Primary outcomes:
measure: Accuracy of different blood glucose monitoring systems (CGM and FGM) with intravenous blood glucose level as the gold standard
timeFrame: 2 weeks
Secondary outcomes:
measure: three-day blood glucose fluctuation of CGM
timeFrame: 3 DAYS
measure: forty-day blood glucose fluctuation of FGM
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06194045: Nutritional Study to Determine the Effect of Fish Oil on Atopic Dermatitis
Official title: A Randomized, Double-blinded Nutritional Study to Determine the Effect of a Concentrated Cetoleic Acid Fish Oil on Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Cetoleic acid
LC-MUFA
Ezcema
Nutritional study
Lead sponsor: Møreforsking AS
Sponsor class: OTHER
Collaborators: name: Helse Møre og Romsdal HF
name: Epax Norway AS
name: University of Manchester
First posted: 2024-01-08
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: PREVENTION

Brief summary: Atopic Dermatitis is associated with pronounced changes in the lipid composition in the skin. The lipid changes are influenced by and contributing to both the inflammatory circuit and the impaired barrier as well as changes in the skin microbiome This nutritional study will investigate the effect of long-chain monounsaturated fatty acid Cetoleic acid on atoptic dermatitis. Earlier studies have shown a anti-inflammatory effect of celoteic acid.

Detailed description: Women and men will be recruited to a placebo or a cetoleic-rich fish oil group and be examined for the effect on atopic dermatitis before, during and after the study period.

Eligibility criteria: Inclusion Criteria:

* Women and men 18-80 years of age.
* Diagnosed with active mild to moderate atopic dermatitis with an EASI of 1.1- 21.0.
* Willing to refrain from oil supplements (omega-3, borage, evening primrose, etc.) for 1 month before study begin (washout) and during the study
* Willing to take the study supplement for 6 months

Exclusion Criteria:

* Known allergy to fish products
* Subjects known to be pregnant or breast feeding
* Subjects perceiving systemically administered medication for AD (other than topical)
* Subjects with auto-immune diseases (except asthma and seasonal/perennial rhinitis)
* Subjects with a diagnosis of other skin diseases

Primary outcomes:
measure: EASI
timeFrame: 6 months
measure: DQLI
timeFrame: 6 months
measure: POEM
timeFrame: 6 months
measure: Itch Numerical Rating Scale (NRS)
timeFrame: 6 months
Secondary outcomes:
measure: Fatty acid composition in red blood cells
timeFrame: 6 months
measure: Lipid compositions in skin
timeFrame: 6 months
measure: Inflammation in skin
timeFrame: 6 months
measure: Blood lipids
timeFrame: 6 months
measure: TEWL
timeFrame: 6 months
measure: Hydroxylated omega-3 fatty acids in plasma
timeFrame: 6 months
measure: Omega-3 index with EASI parameters
timeFrame: 6 months
measure: Cetoleic acid with EASI parameters
timeFrame: 6 months
Other outcomes:
Locations:
city: Ålesund
country: Norway
facility: Helse Møre og Romsdal HF
state: Møre Og Romsdal
Study officials:
affiliation: Helse Møre og Romsdal HF
name: Dag Arne Lihaug Hoff
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05970445: Clinical Phenotypic Characteristics of SC26A4
Official title: Clinical Phenotypic Characteristics of the Solute Carrier Family 26 Member 4 (SC26A4) Mutation in Pendred Syndrome/Nonsyndromic Enlarged Vestibular Aqueduct (PS/NSEVA)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hearing Loss
Pendred Syndrome
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Because the influencing factors and pathological mechanisms of PS/NSEVA patients are intricate, there are many controversies regarding the relationship between the SLC26A4 gene, the degree of hearing loss experienced by PS/NSEVA patients, and the relationship between inner ear imaging and audiology.

Brief summary: The presence or absence of SC26A4, whether combined with Mondini malformation, and patient age, are important factors affecting the degree of hearing loss in the Chinese population.

Detailed description: To summarize the Solute Carrier Family 26 Member 4 (SLC26A4) mutation and clinical phenotypic characteristics of Pendred Syndrome/Nonsyndromic Enlarged Vestibular Aqueduct (PS/NSEVA) patients and provide evidence supporting the clinical diagnosis and genetic counseling of patients with PS/NSEVA. A retrospective cohort study for the Chinese population is needed.

Eligibility criteria: Inclusion Criteria:

1. Patients with Enlarged Vestibular Aqueduct;
2. Patients with hearing loss;
3. Patients with results of SLC26A4 sequencing;

Exclusion Criteria:

Subjects will be excluded from this study if any of the following are present:

1. Audiometric data is incomplete
2. Incomplete basic information
3. Patients who did not undergo HRCT

Primary outcomes:
measure: SLC26A4 sequencing
timeFrame: through study completion, an average of 0.5 year
measure: High-resolution computed tomography of the temporal bone
timeFrame: through study completion, an average of 0.5 year
measure: Hearing test
timeFrame: through study completion, an average of 0.5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Shiming Yang
role: STUDY_CHAIR
References:
Clinical trial NCT03054545: Iguratimod as Treatment for Refractory Lupus Nephritis
Official title: Evaluation of Clinical Efficacy and Immunologic Response After Iguratimod Therapy in Refractory Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lupus Nephritis
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the efficacy and safety of a novel chemical synthetic agent iguratimod as treatment of refractory lupus nephritis. All subjects should have at least one failed immunosuppressive treatment and suffer active nephritis at the screening stage. The study period is 52 week. All the subject will receive therapy of iguratimod combined with steroids.


Eligibility criteria: Inclusion Criteria:

* Active lupus nephritis:

Fulfill ACR classification criteria (2009) for SLE Proteinuria ≥1g/24h at screening stage experience at least one failed therapy within one year before screening, including but not limit to cyclophosphamide, methotrexate, azathioprine, mycophenolate mofetil, cyclosporin, tacrolimus and leflunomide. The regime can be monotherapy or combination. Any regime should be at least applied for six months.

* Body weight ≥40kg
* SLE-2K score ≥8
* Agreement of contraception
* Informed consent obtained

Exclusion Criteria:

* Active severe SLE-driven renal disease or unstable renal disease at screening
* Active severe or unstable neuropsychiatric SLE
* Clinically significant active infection including ongoing and chronic infections
* History of human immunodeficiency virus (HIV)
* Confirmed Positive tests for hepatitis B or positive test for hepatitis C
* Active tuberculosis
* Live or attenuated vaccine within 4 weeks prior to screening
* Subjects with significant hematologic abnormalities
* Abnormal liver function test at screening (ALT, AST or total bilirubin over 2 fold of upper normal level
* History of peptic ulcer or GI bleeding; treatment with warfarin or other anticoagulants within last 14 days

Primary outcomes:
measure: Renal remission rate
timeFrame: Week 52
Secondary outcomes:
measure: Renal remission rate
timeFrame: Week 24
measure: Renal flare rate
timeFrame: Week 52
measure: Number of participants with treatment-related adverse events
timeFrame: Week 52
measure: Systemic Lupus Erythematosus Disease Activity Index inSafety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI)
timeFrame: Week 52
measure: British Isles Lupus Activity Group (BILAG) score
timeFrame: Week 52
measure: PGA
timeFrame: Week 52
measure: Quality of life
timeFrame: Week 52
Other outcomes:
Locations:
city: Shanghai
country: China
facility: RenJi Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT04349345: Seminal Fluid's Changes Over 20 Years
Official title: Seminal Fluid's Changes Over Time: a Single Center 20 Years Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oligospermia
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 24395
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male population who underwent a seminal exam in a tertial fertility care center

Brief summary: This is a cohort study including all the first seminal exams performed at the Fertility Center, Humanitas Research Hospital (Rozzano, Milan) between January 1998 and December 2018.

Detailed description: The objective of this study is to evaluate retrospectively different changes of TPMSC during last 20 years in male population who underwent a seminal exam in our Center

Eligibility criteria: Inclusion Criteria:

* male over 18 years old

Exclusion Criteria:

* error in birth or exam date or age under 18,
* abstinence days \< 3 or \> 6, volume missing o \> 10 ml,
* spermatozoa number/ ml missing o \>220 x106,
* normal forms missing,
* progressive motility missing

Primary outcomes:
measure: Mesaurement of changes of sperm count over time
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03501745: Smart-CKD/BP Study
Official title: Through Remote Management and Propaganda of Intelligent Mobile Phone, the Standard Rate of Blood Pressure Control and the Change of Renal Function Were Observed
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CKD
Lead sponsor: Affiliated Hospital of Qinghai University
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 2
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: OTHER

Brief summary: Through remote management and propaganda of intelligent mobile phone, the standard rate of blood pressure control and the change of renal function were observed.


Eligibility criteria: Inclusion Criteria:

1. diagnosis in line with the 2012 international kidney disease: improving global outcomes (kidney disease improving global out-comes, KDIGO) of chronic kidney disease diagnosis standard of hypertension diagnosis, "China Hypertension Prevention Guide 2010" diagnostic criteria;
2. and will have the use of intelligent mobile phone, and a network connection;
3. at the age of 18-70.

Exclusion Criteria:

1. GFR\<15 ml/min or start replacement therapy;
2. do not understand Chinese, do not understand Chinese;
3. malignant tumor patients;
4. have mental illness;
5. there is consciousness disorder.

Primary outcomes:
measure: Control rate of blood pressure control
timeFrame: 1 year
measure: Drug compliance
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Qinghai
country: China
facility: Pengli Luo
state: Xining
Study officials:
References:
Clinical trial NCT04917445: The Impact of the SPIKES Protocol With IVF Patients
Official title: A Comparison of the SPIKES Protocol for Delivering Bad News to the Current Standard of Care in the in Vitro Fertilization Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: infertility
IVF
Spikes protocol
Lead sponsor: Boston IVF
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
First posted: 2021-06-08
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if the utilization of the SPIKES protocol for delivering bad news is perceived to be more compassionate and effective than the current standard of care for IVF patients receiving negative pregnancy test results.

Detailed description: Presently, nurses at Boston IVF (BIVF) and Weill Cornell Medical Center Division of Reproductive Medicine (Cornell) do not have a scripted method to deliver negative pregnancy tests to in Vitro Fertilization (IVF) patients. This study will invite clinic nurses to assist in the research protocol; half of the nurses will be randomized to be trained on a compassionate way to deliver bad news following the SPIKES protocol, while the other half will continue with the current standard of care of news delivery. The patients who receive the negative test phone calls from participating nurses will be surveyed to see if the method of which the news was delivered was scored as more compassionate, as well as if it was associated with reduced participants reported level of distress and depression.

Eligibility criteria: Inclusion Criteria:

* Female
* Age \>18
* Underwent an embryo or blastocyst transfer using their own eggs at participating clinic
* Able to read and understand English
* Access to email
* Received a negative pregnancy test result phone call from a nurse involved in the research study

Exclusion Criteria:

* Partners of patients undergoing treatment

Primary outcomes:
measure: Assess if the SPIKES-based nursing script is associated with a difference in perceived nursing compassion
timeFrame: Within 48 hours of phone call
measure: Assess patient distress after receiving the negative pregnancy test phone call
timeFrame: Within 48 hours of phone call
measure: Assess patient depression after receiving the negative pregnancy test phone call
timeFrame: Within 48 hours of phone call
Secondary outcomes:
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Boston IVF
state: Massachusetts
city: New York
country: United States
facility: Weill Cornell Medical Center Division of Reproductive Medicine
state: New York
Study officials:
affiliation: Boston IVF
name: Alice Domar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03997045: Exercise During Pregnancy and Urinary Incontinence
Official title: Effect of Physical Exercise Program During Pregnancy on Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Healthy
Keywords: Pregnancy
Physical exercise
Urinary incontinence
Lead sponsor: Universidad Politecnica de Madrid
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* Healthy pregnant women

Exclusion Criteria:

-

Primary outcomes:
measure: Urinary incontinence
timeFrame: Gestational week 36-38
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Politécnica de Madrid
Study officials:
affiliation: Universidad Politecnica de Madrid
name: Ruben Barakat Carballo, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03837145: Propofol for Sedation of Postoperative Electively Ventilated Liver Transplant Recipients.
Official title: Propofol for Sedation of Postoperative Electively Ventilated Liver Transplant Recipients-An Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhoses
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consenting LDLT recipient adult patients ≥ 18 years of age who require postoperative elective ventilation after recieving a living donor liver transplant.

Brief summary: All consenting, adult patients aged 18 years and above who will require elective ventilation after liver transplant recipient surgery will be enrolled for the study. Patients in acute liver failure, hepatic encephalopathy or patients with history of allergic reactions to propofol will be excluded from the study. This is an observational study. As per institute treatment protocol, propofol will be given post-operatively at a dose of 1 mg/kg/hr and than titrated to maintain a Bi-Spectral Index (BIS) score of 60-80 till the patient is on ventilator. There will be no deviation from our routine institutional protocol and no other sedative drugs like opioids or benzodiazepines will be used and no interventions will be done. Hemodynamics will be maintained targeting a mean arterial pressure (MAP) of at least 65 mm Hg. during the study period using appropriate measures.


Eligibility criteria: Inclusion Criteria:

• Living donor liver transplant (LDLT) recipient adult patients ≥ 18 years of age requiring postoperative elective ventilation.

Exclusion Criteria:

* Propofol allergy
* Acute liver failure (ALF).
* Hepatic encephalopathy (HE)

Primary outcomes:
measure: Dosage of propofol in mg/kg/hr required for sedation (BIS:60-80) of postoperative electively ventilated living donor liver transplant recipients.
timeFrame: up to 24 hours
Secondary outcomes:
measure: Changes of propofol dose over the study period to maintain BIS between 60 -80
timeFrame: up to 24 hours
measure: Correlation of the mean dose of propofol in mg/kg/hr with Arterial ammonia at baseline and to see the association between immediate post operative and Postoperative day1 ammonia with corresponding propofol dose.
timeFrame: up to 24 hours
measure: Correlation of propofol dose with respective arterial lactate levels every 2 hours during the period of elective ventilation
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of liver and biliary sciences
state: Delhi
Study officials:
affiliation: Institute of liver and biliary sciences,New Delhi-110070
name: rishabh jaju, DNB
role: PRINCIPAL_INVESTIGATOR
References: