louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06786143: Esmadem Education Model on High-Risk Pregnant Women
Official title: The Effect of Esmadem Education Model on Spiritual Coping, Tolerance and Depression of High-Risk Pregnant Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Risky Pregnancies
Keywords: risky pregnancies
Education
Spiritual
Depression
Lead sponsor: Burdur Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pregnancy is a normal and natural process in a woman's life. During this process, anatomical, physiological, biochemical and emotional changes are observed. During pregnancy, sometimes risk situations arise from the mother, sometimes from the fetus. the scope of prenatal care is high today, the main focus is on the physical aspects of care and medical measures. Midwives who provide holistic care should also address spiritual care. Therefore, the esmadem education model will be conducted to examine the effect of the spiritual coping, tolerance and depression of risky pregnancies.


Eligibility criteria: Inclusion Criteria:

Pregnant women aged 18-45 ,In the second trimester, Primiparous, Have sufficient communication skills, Literate, Can read and understand Turkish, Agree to participate in the research Continuing pregnancy school Having a risky pregnancy diagnosis according to the criteria in the Ministry of Health Pregnancy Risk Assessment Form and having been diagnosed as a risky pregnancy by a physician

Exclusion Criteria:

* Having any mental illness

Primary outcomes:
measure: Religious Coping Scale
timeFrame: aseline and 3 months.
measure: Michel Uncertainty Scale in Illness-Community Form,
timeFrame: aseline and 3 months.
measure: Depression-Anxiety-Stress Scale
timeFrame: aseline and 3 months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05165043: Position Changes in Cirrhosis Hemorrhagic Spot Detection
Official title: Position Changes in Endoscopic Cirrhosis Variceal Hemorrhagic Spot Detection: a Retrospective Study of 11 Cases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Emergency Hemostasis
Keywords: Complications of cirrhosis
Variceal bleeding
Position change
Emergency hemostasis
Rebleeding
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients who conducted position change due to massive EGVB resulting in poor visualization in the stomach were included.

Brief summary: The patients who conducted position change due to massive EGVB resulting in poor visualization in the stomach were included. Those with incomplete information were excluded. The patients were characterized in terms of age, sex, causes of liver cirrhosis, adverse events (AEs) during position change, additional findings after body position change, treatment regimens and follow-up information.

Detailed description: The patients who conducted position change due to massive EGVB resulting in poor visualization in the stomach were included. Those with incomplete information were excluded. The patients were characterized in terms of age, sex, causes of liver cirrhosis, adverse events (AEs) during position change, additional findings after body position change, treatment regimens and follow-up information.

The gastroscopes procedure was started in the left lateral position in all patients. Bleeding varices detected before the position change were stopped by the endoscopic hemostatic measures described above. The following conditions would consider a change of position during gastroscopy: (1) A large amount of blood or blood clot was found after reaching the stomach, making it difficult to suction adequately which led to poor mucosal visuality; (2) Persistent massive bleeding from a blood vessel that filled the stomach cavity rapidly after suction, making it impossible to clarify the bleeding vessel.During position changing procedure, endoscopist withdrew the gastroscope from the stomach and patients changed from the left lateral position to the right lateral position with the help of the nurses. Then endoscopist reinserted the gastroscope into the stomach and tried to detect the addition varices after position change.

Bleeding varices were treated by injection of N-butyl-Cyanoacrylate glue (glub B or Beltran, Compex) or/and Lauromacrogol (Shanxi, Tianyu).

Eligibility criteria: Inclusion Criteria:

* conducted position change due to massive EGVB resulting in poor visualization in the stomach

Exclusion Criteria:

* incomplete information

Primary outcomes:
measure: Incidence of successful hemostasis
timeFrame: within 5 days
measure: Incidence of rebleeding
timeFrame: within 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo first hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT05584943: Kinetics of cEVs Over the 24-hour Dosing Interval After Low-dose Aspirin Administration
Official title: Kinetics of Circulating Extracellular Vesicles Over the 24-hour Dosing Interval After Low-dose Aspirin Administration in Patients at Cardiovascular Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Vesicle
Keywords: circulating extracellular vesicles
aspirin
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 93
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients on low-dose aspirin treatment for cardiovascular prevention (enteric coated, Cardio aspirin 100 mg/die Bayer, Milan, Italy) once daily (o.d.) for at least 1 month

Brief summary: Extracellular vesicles (EVs) are small vesicles deriving from all cell types during cell activation, involved in transcellular communication, and regarded as predictors of vascular damage and of cardiovascular events. The investigators will test the hypothesis that, in patients on chronic low-dose aspirin treatment for cardiovascular prevention, aspirin may affect the release of EVs within the 24 hours interval.


Eligibility criteria: Inclusion Criteria:

* patients on low-dose aspirin treatment for cardiovascular prevention for at least 1 month
* arterial hypertension if well controlled with stable drug therapy
* hypercholesterolemia if well controlled with stable drug therapy

Exclusion Criteria:

* cigarette smoking insufficiency
* clinically significant hepatic insufficiency
* clinically significant renal insufficiency
* clinically significant cardiac insufficiency
* clinically significant pulmonary insufficiency
* history of malignant neoplasms (diagnosed and treated within the past 5 years)
* pregnancy or lactation
* history of malabsorption
* regular (daily) alcohol consumption
* regular (i.e., more than 3 days per week) non steroidal anti-inflammatory drug intake
* type 1 diabetes excluded by islet autoantibodies evaluation (anti-glutamic acid decarboxylase, islet cell cytoplasmic, and IA-2 antibodies), family history of type 1 diabetes, age lower than 40 years, lean phenotype, early requirement for insulin therapy

Primary outcomes:
measure: Kinetics of circulating extracellular vesicles after low-dose aspirin administration
timeFrame: 1st - 12th month
measure: Aspirin response and circulating extracellular vesicles over the 24-hour
timeFrame: 13th - 24th month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05521243: An Exploratory Investigation of a Supplement to Enhance Sleep Quality and Quantity
Official title: An Exploratory Investigation of a Supplement to Enhance Sleep Quality and Quantity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Sleep Disturbance
Sleep Hygiene
Keywords: Sleep
Sleep Disturbance
Sleep Quality
Sleep Quantity
Lead sponsor: Beam
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2022-08-30
Enrollment: 64
Sex: ALL
Minimum age (years): 24
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This double-blind study will examine the effectiveness of Dream Powder and Dream Powder Extra Strength over a six week period. The main outcomes of interest will be sleep quantity and quality, as well as self-reported changes in sleep across the study period.


Eligibility criteria: Inclusion Criteria:

* Self-reported issues with sleep Must be in good overall health with no unstable medical conditions Must own a wearable sleep tracker (i.e., Apple Watch, "FitBit", "Whoop", etc.) Must be willing to discontinue any supplements meant to assist with sleep.

Exclusion Criteria:

* Females who are pregnant or breastfeeding Diagnosis of insomnia or sleep apnea Taking a prescription medication that affects sleep Anyone with a pre-existing condition that would prevent them from adhering to the protocol Anyone with a known history of past severe allergic reactions

Primary outcomes:
measure: Perceived Changes in Sleep Quality as reported by questionnaires
timeFrame: 6 Weeks
measure: Perceived Changes in Sleep Quantity as reported by questionnaires
timeFrame: 6 weeks
measure: Perceived Changes in Sleep Habits as reported by Questionnaires
timeFrame: 6 weeks
measure: Participant Perceptions of Sleep
timeFrame: 6 weeks
Secondary outcomes:
measure: Examine changes in device measured sleep across the six week trial.
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
affiliation: Citruslabs
name: Christopher Hill, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05815043: Effects of Sodium Intake on Arterial Stiffness in Black Men and Women
Official title: Effects of Sodium Intake on Arterial Stiffness in Black Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sodium Intake
Arterial Stiffness
Lead sponsor: Texas State University
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to explore the influence of sodium intake on arterial stiffness in African American/Black adults.


Eligibility criteria: Inclusion Criteria:

* African American or Black
* Male or Female

Exclusion Criteria:

* pregnancy or within 60 days postpartum
* having taken blood pressure (including diuretics beta-blockers, ACE inhibitors, angiotensin receptor blockers, and calcium channel blockers) or statin medications within the past 3 months
* infection (viral or other) within the past 4 weeks
* having adrenal or endocrine tumors (these could impact BP)
* renal disease defined as a glomerular filtration rate (GFR) of less than 60
* prior myocardial infarction
* known coronary heart disease
* personal history of stroke
* heart failure
* cardiac arrhythmias
* recent chest pain or dyspnea
* current insulin dependence
* currently undergoing chemotherapy or radiation
* identifying as transgender (the focus of this trial is biological sex)
* seated systolic or diastolic blood pressure of more than 149 mm Hg or 99 mm Hg, respectively

Primary outcomes:
measure: Cardio-ankle vascular index
timeFrame: This measurement will take approximately 1 minute and will be completed twice.
measure: Ambulatory blood pressure
timeFrame: This measurement will take approximately 24 hours and will be obtained from the date of enrollment until the date of completion of the study up to 10 days after enrollment.
Secondary outcomes:
measure: Renal sodium excretion
timeFrame: This measurement will be obtained from the date of enrollment until the date of completion of the study up to 10 days after enrollment.
Other outcomes:
measure: Hematocrit
timeFrame: This measurement will be obtained from the date of enrollment until the date of completion of the study up to 10 days after enrollment.
Locations:
city: San Marcos
country: United States
facility: Texas State University
state: Texas
Study officials:
References:
Clinical trial NCT04793243: Vitamin D3 Levels in COVID-19 Outpatients From Western Mexico
Official title: Vitamin D3 Levels in COVID-19 Outpatients From Western Mexico: Clinical Correlation and Effect of Its Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: vitamin D
Latin America
supplementation
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The immunomodulatory effects of vitamin D are known to be beneficial in viral infections, it is also known that its deficiency is associated with a worse prognosis of COVID-19. This study aimed to determine the baseline vitamin D serum concentrations in asymptomatic or mildly symptomatic COVID-19 outpatients, as well as to evaluate the effects of supplementation with 10,00 IU/daily of vitamin D3 and its relationship with biochemical parameters and clinical features.


Eligibility criteria: Inclusion criteria:

* Intervention group: Patients with positive PCR for COVID-19 of both sexes supplemented with vitamin D
* Control group: Patients with positive PCR for COVID-19 of both sexes
* Both groups: Mexican individuals, after signing the informed consent letter and over 18 years of age.

Exclusion criteria:

• Diseases that compromise the absorption of Vitamin D; Crohn's disease, cystic fibrosis, and celiac disease.

Primary outcomes:
measure: Baseline levels of serum vitamin D in COVID-19 patients
timeFrame: At baseline
measure: Correlation between D-dimer and vitamin D serum levels in COVID-19 patients
timeFrame: At baseline
measure: Correlation between transferrin and vitamin D serum levels in COVID-19 patients
timeFrame: At baseline
measure: Correlation between ferritin and vitamin D serum levels in COVID-19 patients
timeFrame: At baseline
measure: Effects of vitamin D3 supplementation on COVID-19 patients
timeFrame: After 14 days of supplementation
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Universidad de Guadalajara
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: José F Muñoz-Valle, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05181943: Effectiveness of Photo-biomodulation in the Treatment of Chemotherapy Induced Mucositis
Official title: EFFECTIVNESS OF PHOTO BIO-MODULATION IN THE TREATMENT OF CHEMOTHERAPY INDUCED ORAL MUCOSITIS IN CHILDREN WITH ACUTE LEUKEMIA Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mucositis
Keywords: mucositis - leukemia - chemotherapy
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 44
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the current study was to study the effect of diode laser in the treatment of chemotherapy induced mucositis in young patients suffering from leukemia


Eligibility criteria: Inclusion Criteria:

* children diagnosed with mucositis and receiving chemotherapy

Exclusion Criteria:

* diabetes
* trismus

Primary outcomes:
measure: Self-reported pain level
timeFrame: up to 2 weeks
measure: Oral mucositis lesion size
timeFrame: up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT02895243: Prehabilitation for Adults With End Stage Renal Disease on the Kidney Transplant Waitlist
Official title: Prehabilitation for Adults With End Stage Renal Disease on the Kidney Transplant Waitlist
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure, Chronic
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This pilot study will be a clinical trial to test the feasibility and effectiveness of a kidney transplant (KT) prehabilitation intervention in adults with end stage renal disease (ESRD) who are within 3-6 months of transplantation.

Detailed description: Prehabilitation is the enhancement of functional capacity of a patient to improve their ability to withstand a future stressor. The investigators primary objective is to demonstrate feasibility for prehabilitation in Aim 1 and test whether the number of prehabilitation sessions is associated with increased physical activity. The investigators will formally test whether prehabilitation is associated with a reduction in short term and long term KT outcomes as part of Aim 2. The investigators will test whether there is an effect of prehabilitation on short-term (KT length of stay\> 2 weeks, early hospital readmission and delayed graft function) and long-term (acute rejection (within the first year), 1 year patient and graft survival) outcomes compared to standard of care controls. Participants will be followed for 3-6 months or until they receive a kidney transplant.

Eligibility criteria: Inclusion Criteria:

1. Men and women with end stage renal disease who are within 3-6 months of kidney transplantation and are on the kidney transplant waitlist at Johns Hopkins
2. Must be at least 18 years or older at enrollment
3. Must be English speaking
4. Must be enrolled in an ongoing cohort study of adults with ESRD who are being evaluated for kidney transplantation
5. Must be willing to participate in a prehabilitation program and able to give informed consent

Exclusion Criteria:

1. Patients who have any of the following medical conditions will be excluded from the study:

   * Active Angina pectoris
   * Chronic lung disease and daily use of oxygen
   * Cerebral vascular disease
   * Musculoskeletal conditions that would limit participation in prehabilitation
   * Lower- or upper-extremity amputation
   * Orthopedic disorders exacerbated by physical activity
   * Decreased mental capacity
2. Patients who live outside of Maryland will not be included in the study.

Primary outcomes:
measure: Post kidney transplant mortality
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lutherville
country: United States
facility: Johns Hopkins Physical Medicine and Rehabilitation
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Mara McAdams DeMarco, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02983643: Body Composition Changes During Stem Cell Transplantation: The Case Of Lymphoma Patients
Official title: Body Composition Changes During Stem Cell Transplantation: The Case Of Lymphoma Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hematopoietic Stem Cell Transplantation
Malnutrition
Metabolic Syndrome
Keywords: Skeletal Muscle Index
Visceral Adipose Tissue
Metabolic Syndrome
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
Collaborators: name: Aix Marseille Université
First posted: 2016-12-06
Enrollment: 105
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients having B and T lymphoma who underwent SCT between January 2006 and June 2016 at AUBMC are identified by the research team and are included as per the below inclusion and exclusion criteria.

Brief summary: Skeletal Muscle Index (SMI) and Visceral Adipose Ratio (VAR) assess body composition changes and disclose malnutrition risk effectively. The aims of the study are to assess prevalence of malnutrition in patients planned for SCT, to characterize changes in body composition (SMI, total adipose tissue and VAR) that occur in the peri transplantation phase, and to identify Waist Circumference (WC) cut off points associated with the metabolic syndrome (MetSyn) in patients with B and T cell Lymphoma.

Detailed description: This study is a retrospective cohort study of patients having B and T cell lymphoma, who underwent SCT in the Bone Marrow Transplantation (BMT) unit at AUBMC. Consecutive patients having B and T lymphoma who underwent SCT at AUBMC will be identified by the research team and will be included as per the below inclusion and exclusion criteria. Starting from June 2016, patients who meet the inclusion criteria will be included in the study up until June 2006.

The radiologist will access the AUBMC PACS system to review PET/CT scans of the identified patients. SMI, visceral, subcutaneous and intramuscular adipose tissues will be established by assessing at the level of L3.

Eligibility criteria: Inclusion Criteria:

* Age\>16 years
* Patients having B and T cell lymphoma who have undergone SCT at AUBMC

Exclusion Criteria:

* Patients with a missing pre-SCT PET/ CT scan
* Patients with 2 missing post SCT PET / CT scan

Primary outcomes:
measure: Sarcopenia Prevalence
timeFrame: 3 months post Stem Cell Transplantation
measure: Skeletal Muscle Index Changes
timeFrame: 3 months post Stem Cell Transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
affiliation: AUBMC
name: Jean El Cheikh, MD
role: PRINCIPAL_INVESTIGATOR
References: