louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05768737: Awareness of Osteoporosis in Patients With Hepatitis B Infection
Official title: Awareness of Osteoporosis in Patients With Hepatitis B Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B
Osteoporosis
Osteoporosis Risk
Lead sponsor: Uskudar State Hospital
Sponsor class: OTHER_GOV
First posted: 2023-03-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 to 90 years with hepatitis b virus infection who gave consent to participate in the study.

Brief summary: Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Patients with hepatitis b virus infection are at increased risk for developing osteoporosis. Identifying whether patients with hepatitis b virus infection have information and awareness about this disease is crucial. This study is aimed to investigate awareness and knowledge of osteoporosis in patients with hepatitis b virus infection.

Detailed description: Osteoporosis is a common disease of bone loss. The reduced bone strength predisposes an increased risk for fractures in older individuals. It can affect people from different ethnicity. Many factors increase the risk of osteoporosis, including age, postmenopausal state, glucocorticoid use, low body weight, calcium, vitamin D, immobility, and chronic inflammation. Patients with hepatitis b virus infection are at high risk of developing osteoporosis due to chronic inflammation and their medications. Patients' knowledge and awareness about osteoporosis are essential for early detection, implementation of lifestyle changes, and treatment compliance. This study aimed to investigate osteoporosis awareness and knowledge about osteoporosis in patients with hepatitis b virus infection.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of hepatitis b virus infection
* Must be between the ages of 18 and 99
* Must give consent to participate in the study

Exclusion Criteria:

• Not giving consent

Primary outcomes:
measure: Revised Osteoporosis Knowledge Test
timeFrame: 1 day
Secondary outcomes:
measure: Osteoporosis Self-Efficacy Scale
timeFrame: 1 day
measure: Osteoporosis Health Belief Scale
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Uskudar State Hospital
name: Mustafa H Temel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01447537: Mechanisms Involved in the Benefits of an Exercise Programme in Patients With Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Keywords: Cirrhosis
Exercise
Relaxation
Muscle mass
Effort tolerance
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2011-10-06
Enrollment: 30
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: The investigators conducted a pilot study including 17 patients with liver cirrhosis showing that a moderate exercise programme during three months increased thigh circumference,exercise tolerance and quality of life without adverse effects. The present study aim to more accurately evaluate the effect of exercise on muscle mass, effort tolerance and inflammatory response in patients with cirrhosis. This study will include 30 patients with compensated liver cirrhosis that will be randomized into two groups: exercise group and control group. Evaluation of muscle mass, effort tolerance, inflammatory response and quality of life will be made at the beginning and at the end of the study.

Detailed description: Exercise group: will do a physiotherapist supervised exercise programme 1 hour three times per week during three months and relaxation after exercise. Control group: only relaxation 1 hour three times per week during three months.

Assessment: clinical and laboratory examinations performed at baseline and at the end of the study. The investigators will analyze the changes in muscle mass by anthropometric measurements and advanced techniques (CT scan, densitometry), effort tolerance (stress test), quality of life (sF-36), glutamine synthetase activity in blood, oxidative damage and inflammatory response. The investigators will analyze the survival and complications of cirrhosis during the study and follow-up.

Eligibility criteria: Inclusion Criteria:

* Compensated liver cirrhosis

Exclusion Criteria:

* hepatocellular carcinoma
* active alcoholism (less than 1 year)
* decompensated cirrhosis
* variceal bleeding less than 3 months.
* contraindication for exercise

Primary outcomes:
measure: Increase in muscle mass
timeFrame: Basal and three months
measure: Change in Effort tolerance
timeFrame: Basal and three months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau
name: German Soriano MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roman E, Garcia-Galceran C, Torrades T, Herrera S, Marin A, Donate M, Alvarado-Tapias E, Malouf J, Nacher L, Serra-Grima R, Guarner C, Cordoba J, Soriano G. Effects of an Exercise Programme on Functional Capacity, Body Composition and Risk of Falls in Patients with Cirrhosis: A Randomized Clinical Trial. PLoS One. 2016 Mar 24;11(3):e0151652. doi: 10.1371/journal.pone.0151652. eCollection 2016.
Clinical trial NCT04330937: Clinical Trial on the Effectiveness of Citrolive
Official title: Clinical Trial on the Effectiveness of Citrolive® to Decrease Oxidation of Low Density Lipoproteins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical trial consists in checking the antioxidant effect of citrolive on low density cholesterol.

Detailed description: The clinical trial consists in checking the antioxidant effect of citrolive on low density cholesterol. To do this, volunteers consume the product under study or placebo for three months.

Tests will be performed before and after ingestion of the product.

Eligibility criteria: Inclusion Criteria:

1. Not belonging to the group of individuals considered as priorities by the Third Joint Task Force for the prevention of cardiovascular diseases due to high risk.
2. Present total cholesterol figures greater than 200 milligrams / deciliter and / or low density cholesterol figures greater than 130 milligrams / deciliter so that after applying the cardiovascular risk table (SCORE) they present a current risk of less than 5% of suffer an ischemic event in a period of 10 years, being without pharmacological treatment.
3. Present several cardiovascular risk factors with cholesterolemia figures close to 200 milligrams / deciliters and / or low density cholesterol figures close to 130 milligrams / deciliters.

Exclusion Criteria:

1. chronic or terminal illness.

Primary outcomes:
measure: Blood pressure
timeFrame: The change in systolic and diastolic blood pressure is observed after three months of intake of the product under investigation
measure: Biochemistry and blood count
timeFrame: The change is observed after three months of intake of the product under investigation
Secondary outcomes:
measure: Weight
timeFrame: The change is observed after three months of intake of the product under investigation
measure: Height
timeFrame: The change is observed after three months of intake of the product under investigation
measure: BMI
timeFrame: The change is observed after three months of intake of the product under investigation
measure: Perimeters
timeFrame: The change is observed after three months of intake of the product under investigation
measure: Folds
timeFrame: The change is observed after three months of intake of the product under investigation
measure: Diameters
timeFrame: The change is observed after three months of intake of the product under investigation
measure: Nutritional record
timeFrame: Measurements are made at the beginning and after 90 days of product consumption.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
References:
Clinical trial NCT05248737: Bioavailability of Vitamin D(25(OH)D) and Omega-3 Fatty Acid (DHA) Enhanced Chicken
Official title: Empowering and Transforming the US Broiler Production for Growth, Profit and Sustainability
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Nutrition, Healthy
Keywords: Vitamin D
Omega-3 fatty acids
Lead sponsor: Cornell University
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adults from Ithaca, NY

Brief summary: The purpose of the research is to evaluate if chicken that is fed a diet that contains omega-3 fatty acids (DHA/EPA), vitamin D (as 25(OH)D) or both nutrients provides additional health benefits by improving the status of omega-3 fatty acids and 25(OH)D in healthy adults who eat this bioenhanced chicken.

Detailed description: The 2015-2020 Dietary Guidelines advocate intake of lean proteins (such as chicken and fish) while limiting intake of saturated fat. Chicken contains similar protein to beef or pork but has less saturated fat. However, chicken, like other terrestrial meats, has little omega-3 polyunsaturated fatty acids such as docosahexaenoic acid (DHA) or eicosapentaenoic acid (EPA) and relatively little vitamin D. Vitamin D insufficiency is common in the US and globally, and has been linked to a number of adverse health outcomes. Vitamin D is ingested primarily from fortified dairy products, but recent animal studies have increased the D content of pork and beef, and the DHA content of chicken. Moreover, sunlight exposure alone can enhance the 25(OH)D content of chicken. Notably, supplemental 25(OH)D is more effective than vitamin D at improving vitamin D status in humans, but little is known about the bioavailability of 25(OH)D or DHA/EPA enhanced chicken (muscle).

Eligibility criteria: Inclusion Criteria:

* healthy adults
* Non-smoking
* Age between 18- 24 yo
* Females: premenopausal and not pregnant or lactating
* Body mass index (BMI) between 18 - 30 kg/m2.
* No preexisting medical complications (such as eating disorders, gastrointestinal disorders, malabsorption diseases, or taking medications known to influence iron homeostasis)

Exclusion Criteria:

* BMI \<18 or \> 30 kg/m2,
* Age \<18 y or \> 50y,
* Smoking
* Pregnancy, lactating
* Have gastrointestinal disorders/malabsorption diseases/dietary restrictions/medication use of medications known to impact DHA/EPA or Vitamin D 25(OH)D absorption
* Take vitamin and mineral supplementations

Primary outcomes:
measure: Concentration of plasma DHA concentrations
timeFrame: Baseline, and time course of 1 hour, 2 hour, 4 hour and 8 hour post meal
measure: Concentration of plasma 25(OH)D concentrations
timeFrame: Baseline, and time course of 1 hour, 2 hour, 4 hour and 8 hour post meal
Secondary outcomes:
Other outcomes:
Locations:
city: Ithaca
country: United States
facility: Human Metabolic Research Unit
state: New York
Study officials:
References:
Clinical trial NCT00002137: A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Weekly x 4
Official title: A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Weekly x 4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sarcoma, Kaposi
HIV Infections
Keywords: Neoplasms
Sarcoma, Kaposi
Acquired Immunodeficiency Syndrome
Antineoplastic Agents
tecogalan
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152) and to establish the MTD at each of the different dosing schedules.

Detailed description: Patients receive intravenous DS-4152 by infusion weekly for 4 weeks, followed by 2 weeks of rest; courses may repeat. Patients undergo weekly follow-up. A punch biopsy will be obtained from patients with Kaposi's sarcoma.

Eligibility criteria: Inclusion Criteria

Patients must have:

* Kaposi's sarcoma plus HIV infection OR metastatic solid tumor.
* Life expectancy of at least 12 weeks.
* NO symptomatic AIDS-defining opportunistic infection within the past 4 weeks.
* Recovered from toxicity of any prior anticancer therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Leukemia or lymphoma.
* Current gastrointestinal bleeding by stool guaiac.
* Extensive bone metastases or significant radiographic osteoporosis in patients with solid tumors.
* Active heart disease such as uncontrolled angina, uncompensated congestive heart failure, or dysrhythmias requiring antiarrhythmics.
* Acute intercurrent infection other than genital herpes.
* Symptomatic or known central nervous system involvement (including brain metastases) unless stable and off therapy.

Concurrent Medication:

Excluded:

* Other anticancer therapy.
* Other investigational agents.

Patients with the following prior conditions are excluded:

* History of acute or chronic gastrointestinal bleeding or inflammatory bowel disease.
* History of myocardial infarction within past 6 months.

Prior Medication:

Excluded:

* Anticancer therapy within the past 3 weeks (6 weeks for nitrosourea or mitomycin C).
* Investigational agents within the past 4 weeks.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kenneth Norris Jr Cancer Ctr / USC
state: California
Study officials:
References:
citation: Tulpule A, Snyder JC, Espina BM, Higashi L, Satomi M, Lombardy EE. A phase I study of tecogalan, a novel angiogenesis inhibitor in the treatment of AIDS-related Kaposi's sarcoma and solid tumors (meeting abstract). Gill PS. Blood 1994;84(10, Suppl 1):248a
Clinical trial NCT05701137: Effectiveness of an EMDR Intervention for Perinatal Loss
Official title: Effectiveness of an Eye Movement Desensitization and Reprocessing (EMDR) Intervention for the Prevention of Post-traumatic Symptoms in Perinatal Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Loss
PTSD
Keywords: perinatal loss
PTSD
EMDR
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: EMDR Europe
First posted: 2023-01-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators objectives is to assess the effectiveness of Eye Movement Desensitization and Reprocessing - recent traumatic episode (EMDR-RTE) as a preventive intervention for Posttraumatic Stress Disorder (PTSD) symptoms after perinatal loss.

The hypothesis is that EMDR-RTE treatment may prevent post-traumatic and depressive symptoms in women who suffered perinatal loss.

Detailed description: Perinatal loss is a general term that refers to a loss from conception to one month postpartum. It is a grief that is still socially unauthorized, however, it is a situation with significant traumatic potential. However, there are no studies evaluating the effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) for the prevention or treatment of perinatal loss. We propose an one-site, open label, randomized controlled trial with the aim of assessing the effectiveness of EMDR recent traumatic episode (EMDR-RTE) as a preventive intervention for PTSD symptoms after perinatal loss. A total of 40 women who have suffered a perinatal loss from the Maternal-Fetal Medicine Service of a tertiary university hospital will be recruited. Women will be randomized to EMDR-RTE or treatment as usual (TAU). Researchers will compare EMDR-RTE and TAU to see if women receiving EMDR-RTE treatment had lower levels of post-traumatic and depressive symptoms.

Eligibility criteria: Inclusion Criteria:

* be over 18 years old
* agree to participate and sign the informed consent
* request psychological treatment

Exclusion Criteria:

* active substance use disorder
* cognitive disability
* language barrier

Primary outcomes:
measure: PCL-5
timeFrame: Within the first month after perinatal loss
measure: PCL-5
timeFrame: 3 months after perinatal loss
Secondary outcomes:
measure: STAI S/T
timeFrame: Within the first month after perinatal loss
measure: STAI S/T
timeFrame: 3 months after perinatal loss
measure: BDI-II
timeFrame: Within the first month after perinatal loss
measure: BDI-II
timeFrame: 3 months after perinatal loss
Other outcomes:
measure: Satisfaction survey
timeFrame: 3 months after perinatal loss
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic sede Maternitat
Study officials:
References:
Clinical trial NCT03686137: Institut Paoli Calmettes Hepatic Surgery Database
Official title: Institut Paoli Calmettes Hepatic Surgery Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Surgery
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 3000
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: Patient treated at Institut Paoli-Calmettes who undergo liver surgery for benign liver tumor, primary or secondary liver cancer

Brief summary: Database of patients who undergo hepatic surgery for: benign diseases, primary or secondary liver cancer at Institut Paoli-Calmettes


Eligibility criteria: Inclusion Criteria:

* Patient undergoing liver surgery for benign liver tumor, primary or secondary liver cancer

Exclusion Criteria:

* Patient refusal

Primary outcomes:
measure: Epidemiological description
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Bouches Du Rhone
Study officials:
affiliation: Institut Paoli-Calmettes
name: Ugo Marchese
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01812837: The Use of Microneedles in Photodynamic Therapy
Official title: The Use of Microneedles in Photodynamic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Actinic Keratosis
Keywords: actinic keratosis
microneedles
photodynamic therapy
levulan
Aminolevulinic acid
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2013-03-18
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The global aim of this study is to investigate how microneedles can facilitate the penetration and efficacy of photodynamic therapy in the treatment of actinic keratoses

The specific aims are as follows:

1. Investigate whether pretreatment with microneedles enhances penetration of topical aminolevulinic acid (ALA) that is marketed as Levulan® Kerasticks by DUSA pharmaceuticals Inc.
2. Investigate whether pretreatment with microneedles can decrease the required incubation times of the topical ALA prior to exposure to blue light photodynamic therapy.


Eligibility criteria: Inclusion Criteria:

1. Subjects who are 18 and older
2. Subjects who have at least 3 actinic keratoses on each side of the forehead
3. Subjects who signed an IRB approved informed consent

Exclusion Criteria:

1. Subjects who smoke
2. Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition.
3. Subjects who received a diagnosis of skin cancer on the face in past year
4. Subjects who received field treatment for actinic keratoses to the face in the past 60 days

Primary outcomes:
measure: Actinic Keratoses Reduction Percent
timeFrame: one month after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis, Dermatology
state: California
Study officials:
affiliation: UC Davis
name: Raja K Sivamani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00861237: Homeopathy for Prevention of Atrial Fibrillation After Aortocoronary Bypass Surgery
Official title: Homeopathy for Prevention of Atrial Fibrillation After Aortocoronary Bypass Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: Nux vomica
homeopathy
heart lung machine
heart surgery
postoperatively studied
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-03-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After heart surgery, about 30% of patients suffer from atrial fibrillation. Patients are randomized into two groups receiving either potentized Strychnos Nux vomica or placebo under double blind conditions. Postoperatively, ECGs are done to monitor cardiac rhythm.

Detailed description: Preoperatively, patients receive potentized Nux vomica or placebo sublingually. Then, patients are observed regarding atrial fibrillation postsurgical. The difference between the group of patients with and without nux vomica is recorded.

Eligibility criteria: Inclusion Criteria:

* Patients before elective Heart valve - or aortocoronary by pass surgery with heart-lung-machine.

Exclusion Criteria:

* Pregnant patients
* Patients with preoperative atrial fibrillation and/or hyperthyreosis

Primary outcomes:
measure: Frequency of atrial fibrillation after heart surgery with heart lung machine
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Dept Surgery, Med Univ Vienna
Study officials:
affiliation: Medical University of Vienna
name: Michael Frass, MD
role: PRINCIPAL_INVESTIGATOR
References: