louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06693947: Impact of Alpine Dairy Products on Blood Lipid Levels
Official title: A Pilot Study in the Swiss Alps: Impact of Alpine Dairy Products on Blood Lipid Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elevated Cholesterol
Lead sponsor: University of Fribourg
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Elevated blood lipid levels are one of the main risk factors for cardiovascular disease. To manage elevated blood lipid levels in otherwise healthy people at low risk of cardiovascular disease, lifestyle changes are recommended as the first treatment strategy. One of these changes concerns diet. Clinical observations by general practitioners in alpine regions of Switzerland have shown that consumption of dairy products produced from cows living and grazing at high altitudes can have a beneficial effect on blood lipid parameters. However, little clinical data is available on the effect of alpine dairy products on health-related markers. This pilot study aims to assess if replacing standard (non-alpine) dairy products by alpine dairy products in the daily diet among patients with elevated LDL-cholesterol levels could reduce the blood LDL-cholesterol levels.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old
* Elevated lipid levels, namely: fasting LDL-cholesterol \>3mmol/L and \</=5mmol/L
* Agreeing to eat 3 portions of dairy products daily (according to instructions)

Exclusion Criteria:

* Eating less than two and more than six portions of dairy products daily
* Body weight change +/-5% of body weight in the last three months
* Secondary prevention treatment for cardiovascular disease
* Moderate, high or very high cardiovascular risk according to AGLA score
* Currently taking PSCK9-inhibitors, ezetimibe, statins, glucocorticoids
* Poorly controlled, severe chronic renal insufficiency, hypothyroidism, cholestasis, nephrotic syndrome, eating disorders, alcohol abuse, Cushing syndrome
* Myocardial infarction, percutaneous coronary intervention or coronary artery bypass grafting in the previous 6 months
* Known lactose intolerance or dairy allergies
* Change of diet less than 2 months before intervention
* Pregnant or breastfeeding
* Incapacity of judgement
* Inability to speak and read German

Primary outcomes:
measure: Change in fasting blood LDL-cholesterol level
timeFrame: Baseline, Day 15, Day 30 and Day 45
Secondary outcomes:
measure: Change in total cholesterol, triglycerides, HDL-cholesterol and lipoprotein A
timeFrame: Baseline, Day 15, Day 30 and Day 45
Other outcomes:
Locations:
city: Santa Maria
country: Switzerland
facility: Center da Sandà Val Müstair
Study officials:
affiliation: University of Fribourg
name: Pierre-Yves Rodondi, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT00229047: Ischemia and Reperfusion Injury in the Human: An Observational Study
Official title: Ischemia and Reperfusion Injury in the Human: An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemia
Keywords: Ischemic Preconditioning
Microvascular Perfusion
Inflammation
Ischemia and Reperfusion
Chronic Limb Ischemia
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2005-09-29
Enrollment: 20
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 undergoing routine and elective varicose vein stripping.

Brief summary: We, the researchers at Lawson Health Research Institute, propose to investigate the impact of surgical ischemia and reperfusion on skeletal muscle microcirculation using a hand-held microscope.

Detailed description: We propose to investigate the impact of surgical ischemia and reperfusion on skeletal muscle microcirculation using a hand-held microscope.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing femoral distal bypass procedures for chronic limb ischemia

Exclusion Criteria:

* Any severe comorbid conditions (i.e., chronic obstructive pulmonary disease \[COPD\])

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: Lawson Health Research Institute
state: Ontario
Study officials:
affiliation: Scientist
name: Amit Badhwar, PhD
role: STUDY_DIRECTOR
affiliation: Vascular Surgeon
name: Tom Forbes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00088647: Study Evaluating MST-997 in Advanced Malignant Solid Tumors
Official title: A Phase 1 Dose-Escalation Study of Intravenous MST-997 Formulated in Intralipid 20% Administered Weekly in Subjects With Advanced Malignant Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Neoplasms
Keywords: advanced malignant solid tumors
breast cancer
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2004-08-02
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The primary objective of this clinical research study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD) of intravenous (IV) MST-997 formulated in Intralipid 20% administered on a weekly schedule to subjects with advanced malignant solid tumors.


Eligibility criteria: Inclusion Criteria:

* Documented histological or cytological diagnosis confirming the presence of malignant solid tumor
* Tumor progression after conventional therapy for cancer or a malignant solid tumor for which no conventional therapy exists
* Subjects enrolled in the MTD confirmation cohort should have a documented histologic and/or cytologic diagnosis of metastatic breast cancer or non-small cell lung cancer (NSCLC) and should not have received more than 2 prior chemotherapy regimens for metastatic disease (adjuvant and neoadjuvant chemotherapy will not be included in the maximum of 2 prior regimens described above)

Exclusion Criteria:

* Subjects with symptomatic or clinically active central nervous system (CNS) metastases. Subjects who have had prior treatment with radiotherapy or surgical resection for CNS metastases will be permitted if CNS metastases have remained stable and have not required any treatment for at least 3 months prior to first dose of test article
* History of any other primary malignancy with less than 5 years documentation of a disease-free state (Subjects with a history of basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ, which have been successfully treated, are not excluded)
* Recent major surgery (within 14 days before the first dose) or chemotherapy within 28 days before the first dose of MST-997 (42 days if the previous chemotherapy included nitrosoureas or mitomycin C)

Primary outcomes:
measure: To evaluate the safety, tolerability and MTD of IV MST-997 throughout patients participation on trial.
Secondary outcomes:
measure: To obtain preliminary information on the pharmacokinetics (during cycle 1) and antitumor activity of MST-997 (approximately every 8 weeks).
Other outcomes:
Locations:
city: New York
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Nashville
country: United States
state: Tennessee
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05904847: The Effect of Theory-Based Education on Patient Empowerment and Self-Efficacy in Patients With Type 2 Diabetes
Official title: The Effect of Education Given to Diabetes Patients According to the Planned Behavior Theory on Patient Empowerment and Self-Efficacy: A Single-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabete Type 2
Keywords: Diabetes
Theory Of Planned Behavior
Patient Empowerment
Self-Efficacy
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 98
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: It is essential to manage the disease to prevent and reduce complications and mortality in patients with diabetes. Adequate information and options should be provided to patients by healthcare providers so that patients can make informed choices. Patient education is a patient empowerment process designed to enable patients to be responsible for their health. With this study, it is considered essential to educate diabetic patients according to the theory of planned behavior and to develop self-efficacy by contributing to patient empowerment in this way.


Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study
* 40 years and older
* Diagnosed with type 2 DM at least 1 year ago
* Treated at the hospital where the study will be conducted
* Using antidiabetic agents
* No communication problem
* Contactable by phone

Exclusion Criteria:

* Those who do not meet the inclusion criteria for the study
* Participants who did not give consent at any stage of the study and left

Primary outcomes:
measure: Patient Empowerment Scale
timeFrame: 2 weeks
measure: Diabetes Management Self-Efficacy Scale for Patients with Type 2 Diabetes
timeFrame: 2 weeks
Secondary outcomes:
measure: Blood Glucose Level
timeFrame: 3 months
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University
state: Serdivan
Study officials:
References:
Clinical trial NCT05267847: The Success Rate of Cryotherapy Application in Primary Molars With Signs of Irreversible Pulpitis
Official title: The Success Rate of Cryotherapy Application in Primary Molars With Signs of Irreversible
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Procedural
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 188
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study is designed as a randomized controlled trial with two parallel groups. Children aged 5-9 years with primary molars from suffered symptomatic signs of irreversible pulpitis will be randomly assigned into two groups. The first group (experimental group) will be injected with 4% articaine 1:100.000 epinephrine (inferior alveolar nerve block). For the second group, the mandibular second primary molars will be anesthetized using 4% articaine 1:100.000 epinephrine using inferior alveolar nerve block.


Eligibility criteria: Inclusion Criteria:

* Healthy children are classified as I or II according to ASA
* Presence of at least one mandibular primary molar with symptomatic signs of irreversible pulpitis
* Presence of at least two-thirds of the root length in periapical radiograph

Exclusion Criteria:

* Unrestorable crowns
* Children with systemic, severe behavior or emotional problems
* Presence of gingival redness, swellings, fistulous of sinus tract
* Radiographic evidence of internal root resorption, pulp stones or calcifications, and/or bone radiolucency

Primary outcomes:
measure: Pain assessment
timeFrame: up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Al Minyā
country: Egypt
facility: Omar Ahmed
Study officials:
References:
Clinical trial NCT01006447: Tai Chi/Qigong Exercise Persistence Among Residents of Senior Housing
Official title: Tai Chi/Qigong Exercise Persistence Among Residents of Senior Housing: a Randomized Field Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Physical Activity
Keywords: tai chi
exercise
older adults
exercise persistence
Lead sponsor: D'Youville College
Sponsor class: OTHER
Collaborators: name: Community Health Foundation Western NY
name: People. Inc
First posted: 2009-11-01
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This randomized field trial uses a self-report daily exercise log to answer the research question: Does frequency of instruction influence tai chi/qigong home practice exercise persistence among residents of Senior housing?


Eligibility criteria: Inclusion Criteria:

* Resident of Senior housing,
* Ability to engage in mild exercise
* Vision sufficient to view TV medium
* Willingness to engage in tai chi/qigong training and practice.

Exclusion Criteria:

* Unable to provide informed consent
* Unable to attend initial training session

Primary outcomes:
measure: exercise persistence
timeFrame: 3 months
Secondary outcomes:
measure: perceived benefits
timeFrame: 3 months
measure: barriers to exercise
timeFrame: 3 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: D'Youville College
state: New York
city: Williamsville
country: United States
facility: People, Inc Senior Housing Buildings
state: New York
Study officials:
References:
Clinical trial NCT01042847: How Our Immune System Can Help Fight Cancer
Official title: The Effect of Genetic Polymorphisms in Indoleamine 2, 3-Dioxygenase in Epithelial Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: ovarian
Lead sponsor: Winthrop University Hospital
Sponsor class: OTHER
First posted: 2010-01-06
Enrollment: 169
Sex: FEMALE
Minimum age (years): 20
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 with histologically confirmed epithelial ovarian cancer (EOC) who have had surgical resection for their disease will be included in this study.

Brief summary: There is growing evidence that our immune system can help fight cancer. This has stimulated interest in the development and application of tumor vaccines for several human solid tumors, including epithelial ovarian cancer (EOC). A major obstacle to the development of these vaccines is that there are specialty cells called regulatory T cells that prevent the immune system from attacking all of our organs. These regulatory T cells also prevent our immune system for attacking cancer cells.

Indoleamine 2,3-dioxygenase (IDO), an enzyme that degrades an essential amino acid tryptophan that is necessary for T cells to multiply, however regulatory T cells are less susceptible to low levels of tryptophan, and can still multiply. This allows cancer growth and progression. This may be explained by genetic polymorphisms (changes) in the IDO gene, which may alter its function. Five of these changes in the IDO gene have been described. In this research project, we are asking if you would donate a small piece of your tumor and ascites to see if we can examine your IDO gene in the tumor cells and see if any of these gene changes are present. We hope that this will help us understand how the immune system works in EOC.

We hypothesize that genetic polymorphisms within the IDO gene alter its enzymatic activity and affect the outcome of ovarian cancer patients. These findings have the potential to translate into a method for predicting successful immunotherapy.


Eligibility criteria: Inclusion Criteria:

* females aged 20-90 who are having surgery to confirm epithelial ovarian cancer.

Exclusion Criteria:

* patients who have a diagnosis of non-epithelial histology.

Primary outcomes:
measure: To examine the association of indoleamine 2,3-dioxygenase (IDO) genetic polymorphisms with clinical outcomes of ovarian cancer.
timeFrame: one year
Secondary outcomes:
measure: To correlate IDO activity with gene polymorphisms by measuring tryptophan/kynurenine ratios in the ascites of epithelial ovarian cancer patients.
timeFrame: one year
Other outcomes:
Locations:
city: Mineola
country: United States
facility: Winthrop-University Hospital
state: New York
Study officials:
affiliation: Winthrop University Hospital
name: Jeannine A Villella, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04706247: Thoracic Combined Spinal Epidural Anesthesia for Breast Surgery
Official title: Segmental High Thoracic Combined Spinal Epidural Anesthesia for Breast Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Breast Diseases
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-01-12
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults between 18-75 years of age and who will be to undergo elective breast surgery

Brief summary: The aim of the study is to investigate the efficacy of the thoracic combined spinal epidural anesthesia in breast surgery.

Detailed description: Previous studies of the regional anesthetic techniques such as erector spinae plane block and pectoralis nerve blocks (PECs blocks) additional to general anesthesia have described their use for postoperative analgesia in breast surgery. It has been also reported that these blocks can be used to provide surgical anesthesia in breast surgery . Segmental thoracic epidural anesthesia can be used as an alternative anesthetic technique in patients with severe chronic obstructive pulmonary disease and asthma undergoing breast surgery. It has been also reported that thoracic spinal anesthesia was effective and successful in patients undergoing laparoscopic surgery. In this study, efficacy of high thoracic spinal epidural anesthesia in patients undergoing breast surgery will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients who will be to undergo elective surgery for breast surgery
* American Society of Anesthesiologists (ASA) physical status classification groups I or II

Exclusion Criteria:

* body mass index\>35 kg/m2,
* presence of any condition complicating and contraindicating spinal epidural anesthesia.

Primary outcomes:
measure: Block success
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital
Study officials:
affiliation: Antalya Training and Research Hospital
name: Lutfi Ozyurek, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06866847: Muscle Strength, Muscle Endurance, Lower Extremity Function, Aerobic Capacity, Pressure Pain Threshold and Edema in Women with Lipedema
Official title: Muscle Strength, Muscle Endurance, Lower Extremity Function, Aerobic Capacity, Pressure Pain Threshold and Edema in Women with Lipedema: a Case-Control Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lipedema
Healthy
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with lipedema in Ankara/TURKEY

Brief summary: Lipedema is a chronic progressive disease that causes disproportionate, painful extremities with abnormal fat distribution. Lipedema is known to cause physical and psychosocial disorders in individuals, but there are very limited studies on this subject. The aim of this study is to evaluate muscle strength, muscle endurance, lower extremity function, aerobic capacity, pressure pain threshold and edema parameters in individuals diagnosed with lipedema and to compare them with individuals without lipedema. Volunteer women aged 18 years and older with lipedema (study group) and without lipedema (control group) will be included in the study. After recording the demographic information of the patients, lower extremity muscle strength will be assessed with the K-force handheld dynamometer, lower extremity muscle endurance with the 30 Second Sit-to-Stand Test, lower extremity function with the Lower Extremity Functional Scale, aerobic capacity with the 6-Minute Walking Test, pressure pain threshold with the Baseline algometer, and edema with the moisturemeter. Data from the study and control groups will be recorded in the SPSS program and compared using the appropriate statistical method.


Eligibility criteria: Inclusion Criteria:

* Women over the age of 18 diagnosed with lipedema

Exclusion Criteria:

* Having cardiovascular, orthopedic and/or neurological problems that may affect physical capacity

  * Having diseases such as heart failure, kidney failure that may cause general or localized edema

Primary outcomes:
measure: Assessment of Muscle Strength
timeFrame: only one time
measure: Assessment of Lower Extremity Muscle Endurance
timeFrame: only one time
measure: Assessment of Lower Extremity Function
timeFrame: only one time
measure: Assessment of Aerobic Capacity
timeFrame: only one time
measure: Assessment of Pressure Pain Threshold
timeFrame: only one time
measure: Assessment of Edema
timeFrame: only one time
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Health Sciences
Study officials:
References: