louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06101940: A Multicenter Phenotype-Genotype Analysis of DM1 Patients in China
Official title: A Multicenter Phenotype-Genotype Analysis of Type 1 Myotonic Dystrophy 1 Patients in China
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Myotonic Dystrophy 1
Keywords: Observational
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients will be diagnosed and invited to join this trial in each participating neuromuscular diagnostic centers.

Brief summary: Myotonic dystrophy 1 (DM1) is an autosomal, dominantly inherited neuromuscular disorder characterized by skeletal muscle weakness, myotonia, cardiac conduction abnormalities, cataracts, and other abnormalities. This disease results from an expansion of a cytosine-thymine-guanine (CTG) trinucleotide repeat in the 3'-untranslated region of the dystrophia myotonica protein kinase (DMPK) gene on chromosome 19. Currently, there is limited phenotype and genotype data available for DM1 patients with Chinese Han ethnicity. Therefore, this study aims to fill this gap and provide complementary data.

Detailed description: This is a multicenter-based, prospective, observational study that primarily focuses on the diagnosis and progression of DM1 patients in China. The investigators collect patient data, including basic information, strength evaluations, genetic data, electromyography results, cognitive performance, and MRIs.

Eligibility criteria: Inclusion Criteria:

* Age between 18-80 years
* With enough cognitivie ability to understand the content and sign the informed consent form
* With CTG repeats \>50 in DMPK gene, revealed by PCR test

Exclusion Criteria:

* Patients with severe mental illness, or severe anxiety and depression
* With comorbidities such as traumatic brain injury and cranial tumors
* A history of alcoholism, psychotropic substance abuse, etc.
* Patients with severe medical conditions and unstable vital signs that cannot tolerate the tests.
* Female in pregnancy

Primary outcomes:
measure: Changes in 10 Metre Walk Test (10MWT)
timeFrame: Baseline, Year 3, Year 5
Secondary outcomes:
measure: Changes in ESS scale
timeFrame: Baseline, Year 3, Year 5
measure: Changes in 6-Minute Walk Test
timeFrame: Baseline, Year 3, Year 5
measure: Changes in FSS scale
timeFrame: Baseline, Year 3, Year 5
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
Study officials:
affiliation: Huashan Hospital
name: Chongbo Zhao, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05849740: An Exploratory Study of Cluster of Differentiation 38 (CD38) Monoclonal Antibody Combined Corticosteroid in Acquired Hemophilia A
Official title: A Multicenter, Single-arm Exploratory Study of CD38 (Daratumumab) Monoclonal Antibody (Daratumumab) Combined Corticosteroid in the Treatment of Acquired Hemophilia A (AHA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Acquired Hemophilia
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the time of response, sustained remission rate and relapse rate of CD38 monoclonal antibody (Daratumumab) combined corticosteroid in the treatment of AHA. To evaluate the safety of CD38 monoclonal antibody in the treatment of AHA.

Detailed description: This is a prospective ,single-arm, multi-center controlled pilot trial of CD38 (Daratumumab) monoclonal antibody combined corticosteroid in the treatment of AHA patients.

Patients will receive Daratumumab and corticosteroid treatment in this trial.

Eligibility criteria: Inclusion Criteria:

* Patients must meet all enrollment criteria before they can be enrolled:

Diagnosed as AHA; Women are postmenopausal women or women of childbearing age with strict contraception; Patients with good compliance

Exclusion Criteria:

* Patients with any of the following items cannot be enrolled in this study:

Congenital hemophilia with inhibitor; Pregnant and lactating women; Who are positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody (Ⅰ + Ⅱ) and syphilis antibody; Patients with poor compliance; Who cannot use contraception during the trial; Researchers believe that it is not appropriate for patients to participate in any other condition of this trial; Four weeks before entering the group, the patients received immunosuppressive therapy and the inhibitor showed a progressive decreasing trend (the change was less than 50%).

Acquired von Willebrand disease

Primary outcomes:
measure: Total response rate to treatment (OR) Total response rate to treatment
timeFrame: During 8 weeks
Secondary outcomes:
measure: the proportion of patients with complete remission (CR)
timeFrame: During 8 weeks
measure: the proportion of patients with partial remission rate (PR)
timeFrame: During 8 weeks
measure: time to CR
timeFrame: During 8 weeks
measure: The proportion of patients remaining in CR during 24 weeks
timeFrame: During 24 weeks
measure: The proportion of patients relapse after reaching CR during 24 weeks
timeFrame: During 24 weeks
measure: Safety outcome
timeFrame: From start of the treatment until the end of 24 weeks in the follow-up period
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Chinese Academy of Medical Science and Blood Disease Hospital
Study officials:
affiliation: Chinese Academy of Medical Science and Blood Disease Hospital
name: Lei Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05502640: Chicken Model in Teaching Episiotomy Repair
Official title: The Effect of Chicken Model in Teaching Episiotomy Repair on Satisfaction, Self-Confidence, and Anxiety Levels of Midwifery Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Episiotomy Wound
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to determine the effect of chicken use in episiotomy repair training of midwifery students on students' satisfaction, self-confidence and anxiety levels.

Hypotheses H01 There is no difference between the satisfaction score of the chicken group and the satisfaction score of the control group in episiotomy repair training.

H02 In episiotomy repair training, there is no difference between the self-confidence score of the chicken group and the self-confidence score of the control group.

H03 There is no difference between the anxiety score of the chicken group and the anxiety score of the control group in episiotomy repair training.


Eligibility criteria: Inclusion Criteria:

* Midwifery students who were registered in the midwifery department in the 2020-2021 academic year and take childbearing course,
* Students over the age of 18

Exclusion Criteria:

* Having previously received training on episiotomy and its repair,
* Students who fill in the data collection forms incompletely will not be included in the study.

Primary outcomes:
measure: Change in The State-Trait Anxiety Inventory (STAI)
timeFrame: immediately before the training, immediately after the training and immediately after the clinical practice.
measure: Change in satisfaction
timeFrame: immediately before the training, immediately after the training and immediately after the clinical practice.
measure: Self-Sufficiency
timeFrame: immediately before the training, immediately after the training and immediately after the clinical practice.
measure: The Student Satisfaction and Self-Confidence in Learning Scale
timeFrame: immediately after training
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Nursing
Study officials:
References:
Clinical trial NCT06107140: Duration of Dual Antiretroviral Therapy in Virologically Suppressed People Living With HIV and Factors Associated With Switching to Tritherapy : a Real-life Cohort
Official title: Duration of Dual Antiretroviral Therapy in Virologically Suppressed People Living With HIV and Factors Associated With Switching to Tritherapy : a Real-life Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: epidemiology
Lead sponsor: Tourcoing Hospital
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed up in a referral center for the management of PLHIV who started dual antiretroviral therapy in the period from 2011 to 2023 and whose viral load was \< 50 copies/ml before initiation of dual therapy.

Brief summary: HIV infection requires lifelong continuous antiretroviral (ARV) treatment. The efficacy of current ARV treatments makes it possible to propose strategies for reducing the cumulative exposure to ARVs, side effects and costs. And so improve the quality of life of people living with HIV (PLHIV). However, in the real world, less regular adherence to treatment, more heavily pre-treated patients and resistance to treatment make these dual therapies prescribed beyond the strict framework of clinical trials. This can lead to undesirable side effects. From the perspective of personalized medicine, it seems to be important to determine which patients are receiving dual ARV therapy, and which patients remain on it for a long time. Identifying prognostic factors would enable us to adapt therapeutic management.


Eligibility criteria: Inclusion Criteria:

* hiv patient
* viral load \< 50copies/ml
* patient treated with dual therapy
* patients with hospital follow-up between 2011 and 2023

Exclusion Criteria:

* adults under legal protection
* underage

Primary outcomes:
measure: therapeutic switch
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tourcoing
country: France
facility: Centre Hospitalier DRON
Study officials:
References:
Clinical trial NCT00886340: A Lifestyle Change Program to Prevent Type 2 Diabetes
Official title: A Lifestyle Change Program to Prevent Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prediabetes
Keywords: diabetes prevention, primary care
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2009-04-22
Enrollment: 58
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to evaluate the effect of a diabetes prevention program provided by nurse practitioners in primary care to adults at risk for diabetes.


Eligibility criteria: Inclusion Criteria

* age 21 or older
* medically stable and safe to exercise
* at high risk for type 2 diabetes
* able to speak English.

Exclusion Criteria

* Type 2 diabetes
* Cardiovascular disease
* Cancer requiring treatment in the past 5 years
* Anemia
* Hepatitis
* Renal disease
* Gastrointestinal disease
* Recent or significant abdominal surgery
* Pulmonary disease with dependence on oxygen or daily use of bronchodilators
* Chronic infection (ie., HIV, active tuberculosis)
* Unable to walk 0.25 miles in 10 minutes
* Participation in commercial diet program
* Currently pregnant or within 3 months postpartum
* Currently nursing or within 6 weeks of having completed nursing
* Treatment of impaired glucose tolerance (IGT) with metformin
* Currently taking any glucocorticoid or beta-blocker
* Recently prescribed or changed dose of a statin (within 2 months)

Primary outcomes:
measure: Number of Participants Who Met Weight Loss Goal of 5% Weight Loss
timeFrame: 6 months
Secondary outcomes:
measure: Diet and Exercise Behavior
timeFrame: 6 months
measure: Lipids
timeFrame: 6 months
measure: Quality of Life
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Yale School of Nursing
name: Robin Whittemore, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Whittemore R, Melkus G, Wagner J, Dziura J, Northrup V, Grey M. Translating the diabetes prevention program to primary care: a pilot study. Nurs Res. 2009 Jan-Feb;58(1):2-12. doi: 10.1097/NNR.0b013e31818fcef3.
Clinical trial NCT02334540: Satiety Effects of Pulses Compared to Matched Protein Smoothie
Official title: Satiety Effects of Pulses Compared to Matched Protein Smoothie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Selection
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-01-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The satiety effects of pulses compared to a matched smoothie will be measured.

Detailed description: The investigators will compare satiety and food intake after consumption of purses or a calorie/protein matched smoothie

Eligibility criteria: Inclusion Criteria:

* healthy, normal body weight,

Exclusion Criteria:

* smoker, restrained eating habits, recent weight change, history of disease, vegetarian, do not normally eat breakfast or lunch, are pregnant or lactating, have irregular menstrual cycles

Primary outcomes:
measure: satiety
timeFrame: 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: St. Paul
country: United States
facility: Department of Food Science and Nutrition
state: Minnesota
Study officials:
References:
Clinical trial NCT01115140: Metformin and Folate in Pregnant Polycystic Ovary Syndrome(PCOS) Women
Official title: Effect of Metformin With or Without Folate Addiction on Uterine Blood Flow and Trophoblastic Invasion in Pregnant Patients With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy
Polycystic Ovary Syndrome
Keywords: Folate
Metformin
PCOS
Pregnancy
Trophoblastic invasion
Uterine artery velocimetry
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2010-05-04
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A more recent prospective nonrandomized placebo-controlled double-blind clinical study demonstrated that metformin exerts a slight but significant deleterious effect on serum homocysteine (Hcy) levels in patients with PCOS, and supplementation with folate is useful to increase the beneficial effect of metformin on the vascular endothelium.

Detailed description: PCOS (cases) and non-PCOS (controls) pregnant women were enrolled. Cases will be randomized in four treatment groups: metformin plus placebo (group A1), metformin plus folic acid (group A2), placebo plus folic acid (group A3), placebo alone (group A4). Controls will not received any treatment (group B). Clinical and biochemical assessment (including serum markers of implantation), Doppler velocimetry of the uterine arteries, and trophoblastic invasion at histological and immunohistochemical evaluation.

Changes in clinical and biochemical data under treatment, pattern of Doppler velocimetry at the uterine arteries, and trophoblastic invasion were evaluated.

Eligibility criteria: Inclusion Criteria:

* Pregnancy
* PCOS

Exclusion Criteria:

* Risk factors for pregnancy complications
* Severe obesity

Primary outcomes:
measure: Trophoblastic invasion.
timeFrame: two weeks
Secondary outcomes:
measure: Doppler velocimetry measurements of the uterine artery.
timeFrame: two weeks
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: "Pugliese" Hospital
Study officials:
affiliation: Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
name: Fulvio Zullo, MD
role: STUDY_CHAIR
affiliation: Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
name: Stefano Palomba, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05026840: GDM Screening During COVID Pandemic. IADPSG vs WHO '99 Criteria
Official title: Screening of GDM During COVID Pandemic in an Italian Setting. Comparison Between IADPSG and WHO '99 Criteria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: GDM Screening During COVID Pandemic
Comparison Between IADPSG vs WHO '99 Criteria
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pregnant women who in a 12-month period perform GDM screening and then deliver at our University Hospital

Brief summary: All pregnant women who performed an OGTT following Italian Guidelines and then delivered at our University Hospital from march 2020 to march 2021 were prospectively enrolled in this study. Primary outcome of the study was the number of women to whom was diagnosed GDM with only the fasting glucose value (≥ 92 mg/dl), following Italian Diabetes Societies recommendations for COVID 19 pandemic period. In the same time, we prospectively collected the data of women who became diabetic following the criteria of WHO 1999 (fast glucose value ≥ 120 mg/dl, 2 hours later ≥ 140 mg/dl) still in use in some large countries like India. From the clinical charts, we reported the distribution of risk factors for GDM (maternal age ≥ 35 years, family history for diabetes type 2, ethnia, BMI ≥ 25, previous GDM) and clinical outcomes such as hypertensive disorders, preterm birth, macrosomia, intrauterine growth restriction and Caesarean section in emergency.

These data will be compared between the 2 groups consisting in those diagnosed with only IADPSG criteria versus those diagnosed with only WHO '99 criteria.


Eligibility criteria: Inclusion Criteria: Pregnant women who perform GDM screening -

Exclusion Criteria: Twin pregnancies

-

Primary outcomes:
measure: prevalence of women with a diagnosis of GDM following guidelines during COVID pamdemic
timeFrame: from march 2020 to march 2021
Secondary outcomes:
measure: GDM diagnosis with IADPSG criteria versus WHO '99 criteria
timeFrame: from March 2020 to March 2021
Other outcomes:
Locations:
city: Messina
country: Italy
facility: University Hospital
Study officials:
References:
citation: van-de-l'Isle Y, Steer PJ, Watt Coote I, Cauldwell M. Impact of changes to national UK Guidance on testing for gestational diabetes screening during a pandemic: a single-centre observational study. BJOG. 2021 Apr;128(5):917-920. doi: 10.1111/1471-0528.16482. Epub 2020 Oct 7.
citation: D'Anna R, Di Benedetto A, Palella S, Miceli A, Romeo P, Corrado F. Screening of GDM during COVID pandemic in an Italian setting: comparison between IADPSG and WHO '99 criteria. Diabetol Metab Syndr. 2022 Oct 31;14(1):164. doi: 10.1186/s13098-022-00936-4.
Clinical trial NCT05542940: P53 Immunohistochemistry Abnormal Staining in Endometrial Cancer
Official title: P53 Immunohistochemistry Abnormal Staining in Endometrial Cancer and Its Relation With Disease Stages, Pathological Types and Grading
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Cancer
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: randomized

Brief summary: Objective: Calculate the incidence of P53 immunohistochemistry abnormal staining in endometrial cancer and to identify its relation with disease stages, pathological types and grading.

Patients and methods:

100 cases of endometrial cancer will be included in the study, recruited from Alexandria university hospital gyne-oncology unit. Surgical staging, histopathological examination and immunohistochemistry of p53 were done to all cases to calculate the incidence of P53 immunohistochemistry abnormal staining in endometrial cancer and to identify its relation with disease stages, pathological types, grading.

Keywords: P53 immunohistochemistry, endometrial cancer, clinicopathological relation.


Eligibility criteria: Inclusion Criteria:

* endometrial cancer patients

Exclusion Criteria:

* patients unfit for surgery

Primary outcomes:
measure: p53 immunohistochemistry
timeFrame: 1 month
measure: Relation of p53 abnormal staining with disease stages
timeFrame: 1month
measure: Relation of p53 abnormal staining with disease pathological types
timeFrame: 1 month
measure: Relation of p53 abnormal staining with disease pathological grades
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Hossam Hassan El Sokkary
Study officials:
References: