louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03824613: Urinary miRNA in Endometrial Cancer Study
Official title: Urinary microRNA Expression in Endometrial Cancer Patients - a Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Cancer
Lead sponsor: Royal Cornwall Hospitals Trust
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 164
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: Endometrial cancer patients

Brief summary: This study is a prospective feasibility study with the addition of a retrospective cohort study on the the expression of microRNA in urine in endometrial cancer patients.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of endometrial cancer
* Age: 18 years or older

Exclusion Criteria:

* Prior or coexisting other malignancies
* Autoimmune disorders (other than diabetes mellitus)

Primary outcomes:
measure: Accuracy of predictive value of miRNA test in detecting endometrial cancer
timeFrame: 6 months
Secondary outcomes:
measure: Correlation to final histology
timeFrame: 6 months
Other outcomes:
Locations:
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
state: Cornwal
Study officials:
References:
Clinical trial NCT05644613: Comparative Study Between The Effect Of Aerobic Exercises On Land and Aerobic Exercises In Water On PMS Syndrome
Official title: Effect Of Aerobic Exercises On Land Versus Aerobic Exercises In Water In The Management Of Premenstrual Syndrome In Adolescent Girls
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premenstrual Syndrome
Keywords: premenstrual syndrome
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many girls experience premenstrual syndrome PMS which is re a group of physical, cognitive, affective, and behavioural symptoms that occur cyclically during the luteal phase of the menstrual cycle and resolve at or within a few days of the onset of menstruation. In young adolescents symptoms might particularly affect school functions, and social interactions in a negative ways in this study we will figure out the effect of 2 kinds of exercises in the management of this syndrome.

Detailed description: Fourty adolescent girls were divided randomly into two equal groups, Group (A) will consist of (20) adolescent girls age ranged from 14-17 suffering from PMS without any pathological cause they will receive an aerobic exercise on land in form of walking on the treadmill for 20 min 3 times per week for 3 months. Group (B) will consist of (20) adolescent girls age ranged from 14-17 suffering from PMS without any pathological cause they will receive an aerobic exercises in water in form of walking on the treadmill for 20 min 3 times per week for 3 months the assessment of the PMS symptoms will be done by Premenstrual distress questionnaire

Eligibility criteria: Inclusion Criteria:

* All participants virgin females.
* Their age ranged from 14 to 17 years old
* their body mass index (BMI) ≥ 18 ≤ 25 kg/m2.
* They are clinically and medically stable during the study,
* they have regular menstrual cycle of 23 to 35 days and not participated any type of unusual diet during the period of the study.

Exclusion Criteria:

* All females in this study are free from: cardiopulmonary or orthopaedic problems, taking any hormonal drugs for three months at least, participating in any form of activity rather than the prescribed one in the study, any abnormality in ovulation or pelvic inflammatory diseases (PID).

Primary outcomes:
measure: Premenstrual syndrome symptoms
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Badr University
Study officials:
affiliation: Badr University
name: Mina Atef, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT04924413: L-TIL Plus Tislelizumab as First-line Treatment in Advanced Malignant Melanoma
Official title: L-TIL Plus Tislelizumab as First-line Treatment in Advanced Malignant Melanoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Malignant Melanoma
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2021-06-14
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: L-TIL and Tislelizumab
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the safety and effectiveness of liquid tumor infiltrating lymphocytes (L-TIL) combined with tislelizumab as the first-line treatment in patients with advanced malignant melanoma. This study plan to include stage III or IV unresectable or metastatic cutaneous or acral malignant melanoma patients, treat with L-TIL 4 cycles with each infusion (3 -10) x10\*9/m2 cells, combined with tislelizumab 200mg, iv, Q3W. It is expected that 30 patients will be enrolled in this study.


Eligibility criteria: Inclusion Criteria:

1. Pathological confirmed melanoma 2. Advanced stage confirmed by radiological examination 3. Untreated 4. ECOG PS 0-1 6. Good organ function 7. No other severe diseases such as autoimmune disease, organ transplant, chronic infection.

8. Other tumor disease.

Exclusion Criteria:

1. Symptomatic brain metastases
2. Active infection
3. Active HBV or HCV infection
4. HIV infection
5. Autoimmune disease
6. Sensitive to drug or ingredients
7. Severe mental disorders
8. Sever disfunction of heart, liver and kidney

Primary outcomes:
measure: Efficacy (ORR)
timeFrame: 8 weeks
measure: Efficacy (ORR)
timeFrame: 16 weeks
measure: Efficacy (DOR)
timeFrame: 1 year
measure: Efficacy (DOR)
timeFrame: 2 years
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: 1 year
measure: Progression free survival (PFS)
timeFrame: 2 years
measure: Overall survival (OS)
timeFrame: 1 year
measure: Overall survival (OS)
timeFrame: 2 years
measure: Safety (adverse events)
timeFrame: 2 years
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Quanli Gao, Ph.D
role: STUDY_DIRECTOR
References:
citation: Li T, Zhao L, Yang Y, Wang Y, Zhang Y, Guo J, Chen G, Qin P, Xu B, Ma B, Zhang F, Shang Y, Li Q, Zhang K, Yuan D, Feng C, Ma Y, Liu Z, Tian Z, Li H, Wang S, Gao Q. T Cells Expanded from PD-1+ Peripheral Blood Lymphocytes Share More Clones with Paired Tumor-Infiltrating Lymphocytes. Cancer Res. 2021 Apr 15;81(8):2184-2194. doi: 10.1158/0008-5472.CAN-20-2300. Epub 2021 Jan 6.
Clinical trial NCT06068413: CT Image-assisted Detection Software for Focal Liver Lesions
Official title: A Retrospective, Multicenter, Multiple-viewer-multiple-case (MRMC) Clinical Trial to Evaluate the Safety and Efficacy of CT Image-assisted Detection Software for Focal Liver Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focal Liver Lesion
Keywords: CT image-assisted detection software
focal liver lesion
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Ningbo No.2 Hospital
name: Shenzhen Sixth People's Hospital
First posted: 2023-10-05
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the safety and effectiveness of the developed and produced CT image-assisted detection software for focal liver lesions before being put into the market.


Eligibility criteria: Inclusion Criteria:

* doctors have liver CT scanning experience more than 1 year;

Exclusion Criteria:

* persons don't have the license of practicing physician; doctors don't have liver CT scanning experience or have liver CT scanning experience less than 1 year;

Primary outcomes:
measure: AFROC
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT02558413: Phase 1 Safety and Pharmacokinetics Study of Single Ascending Doses of BTA-C585 in Healthy Volunteers
Official title: A Double-Blind, Placebo-Controlled, Single Ascending Oral Dose Study of the Safety and Pharmacokinetics of BTA-C585 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Healthy Volunteers
Keywords: Viral Diseases
Antiviral
Paramyxoviridae Infections
RSV
Respiratory Syncytial Virus
Aviragen Therapeutics, Inc.
Aviragen Therapeutics
Aviragen
Lead sponsor: Vaxart
Sponsor class: INDUSTRY
First posted: 2015-09-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a placebo-controlled, double-blind, randomized, single dose escalation Phase 1 clinical trial to determine the safety and tolerability of BTA-C585 administered orally to healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women aged 18-60 years;
* Weight ≥ 50 kg and Body Mass Index (BMI) of 19 to 32;
* Female subjects must be of non-childbearing potential;
* Male subjects must agree to use a double barrier method of birth control;
* Able to provide informed consent

Exclusion Criteria:

* Current or recent (within 14 days of Day 0) bacterial or viral infection;
* Positive results for hepatitis B, hepatitis C, or HIV;
* Clinically significant abnormalities noted on ECG;
* Safety laboratory abnormalities;
* Regular use of medications, prescription or non-prescription;
* Poor vein access or fear of venipuncture;
* Major surgery, significant recent injury or trauma within 30 days;
* Received an investigational drug or vaccine within 30 days

Primary outcomes:
measure: Number of adverse events
timeFrame: Day 0 to Day 11
measure: Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours
timeFrame: 0-24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Biota Investigational Site
state: Texas
Study officials:
affiliation: Biota Pharmaceuticals, Inc.
name: Anna Novotney-Barry
role: STUDY_DIRECTOR
References:
Clinical trial NCT02615613: The Effect of Food Hedonics on Appetite Hormones Levels
Official title: Effect of Food Acceptability on Appetite Hormones' Response in Normal Weight Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Behavior
Keywords: Hedonics, Ghrelin, Hunger
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2015-11-26
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 30-40 healthy male subjects with a BMI between 18.5 and 24.9 kg/m2 will be tested for food preferences using a questionnaire with 141 different foods. Accordingly, a high acceptability/palatability food will be selected (average score of ≥ 7 on the 9-point hedonic scale). Two versions of the selected high palatability food will be devised by modifying it to yield the original high and the modified low acceptability versions. The two versions will differ only in palatability and will be equicaloric. Subjects who agree on the acceptability of the two versions of the food (11 subjects) will consume, at fasting, the two versions of the food in a cross over design over two sessions. Each session will include an acceptability test, using the 9-point hedonic scale, on three instances: after sampling a spoonful, eating the whole portion and after 240 min. The quantity consumed on each session will constitute 30% of the subject's resting energy expenditure. Moreover, fasting and postprandial hunger ratings and blood samples will be collected at time 0 and after 15, 30, 60, 120, 180 and 240 min of the food/meal's ingestion. The visual analogue scale will be used for huger ratings.


Eligibility criteria: Inclusion Criteria:

* Gender: Male
* Age: 18-50 years
* Body Mass Index (BMI): 18.5-24.9 kg/m2
* Stable body weight for at least three months before the study with absence of any form of dieting, food restriction or other abnormal eating behaviors (to minimize effect of weight change on ghrelin status)

Exclusion Criteria:

* Smoking
* Substance abuse such as alcohol or drugs
* Medical or psychological illness
* Use of medications
* Previous gastrointestinal surgery
* History of weight fluctuation (weight loss of greater than 5% within the past 3 months)

Primary outcomes:
measure: Food acceptability score
timeFrame: Two weeks
measure: Ghrelin level
timeFrame: Two weeks
Secondary outcomes:
measure: Glucose level
timeFrame: Two weeks
measure: Appetite score on the visual analogue scale
timeFrame: Two weeks
measure: Insulin level
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02381613: Postprandial Differences After Herring and Beef
Official title: Postprandial Plasma Nutrient Differences Between Baked Beef, Baked Herring and Pickled Herring.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Fish
Herring
Meat
Beef
Lead sponsor: Chalmers University of Technology
Sponsor class: OTHER
Collaborators: name: Oy Foodfiles Ltd
First posted: 2015-03-06
Enrollment: 17
Sex: MALE
Minimum age (years): 35
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: While observational studies often find that diets rich in fish reduce the risk of disease, and that diets including a high intake of red meat are associated with increased risk of cardiovascular disease and cancer, the difference in health effects between red meat and fish are rarely researched in intervention studies.

The investigators hypothesise that the post-prandial plasma response of lipids and markers of cardiovascular disease risk will be more favourable after intake of herring compared to beef.

In addition, while pickling herring in a brine/sugar solution is a common form of preparation, little is known if there is a difference in potential health effects based on the preparation of herring. The investigators will compare baked and pickled herring to understand if preparation is potentially an important factor to be considered when looking at intake of fish and health.


Eligibility criteria: Inclusion Criteria:

* Male
* 35-67 years
* BMI \>30 kg/m2
* Normally eats lunch and dinner

Exclusion Criteria:

* Smoke or oral tobacco use
* Use of prescription or recreational drugs likely to interfere with primary outcome
* Change in body weight in the month prior to the study
* Abnormal blood biomarker values (assessed by a clinician)

Primary outcomes:
measure: Omega-3 fatty acids
timeFrame: Area under the curve between 0 and 7 hours
Secondary outcomes:
measure: Plasms insulin
timeFrame: Area under the curve between 0 and 7 hours
measure: Plasma triglycerides
timeFrame: Area under the curve between 0 and 7 hours
measure: Plasma lipoprotein-cholesterol
timeFrame: Area under the curve between 0 and 7 hours
measure: Plasma vitamin D
timeFrame: Area under the curve between 0 and 7 hours
measure: Plasma metabolomic profile
timeFrame: Area under the curve between 0 and 7 hours
measure: Urinary metabolomics
timeFrame: Area under the curve between 0 and 7 hours
Other outcomes:
Locations:
Study officials:
References:
citation: Ross AB, Svelander C, Undeland I, Pinto R, Sandberg AS. Herring and Beef Meals Lead to Differences in Plasma 2-Aminoadipic Acid, beta-Alanine, 4-Hydroxyproline, Cetoleic Acid, and Docosahexaenoic Acid Concentrations in Overweight Men. J Nutr. 2015 Nov;145(11):2456-63. doi: 10.3945/jn.115.214262. Epub 2015 Sep 23.
Clinical trial NCT05521113: Home-based Pulmonary Rehabilitation With Remote Monitoring in Pulmonary Arterial Hypertension
Official title: Feasibility of Home-based Pulmonary Rehabilitation With Remote Monitoring in Pulmonary Arterial Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 14
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: Subjects identified with the medical diagnoses of Pulmonary Arterial Hypertension (PAH) from the Mayo Clinic in Rochester, MN PH clinic.

Brief summary: The purpose of this study is to test new technology and health coaching aimed to help people with PAH become more physically active in their daily lives.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of PAH, confirmed by right heart catheterization (mean pulmonary artery pressure of 20 mmHg or greater, pulmonary vascular resistance of 3.0 Woods units or greater, Pulmonary capillary wedge pressure of 15 mmHg or lower).
* On PAH-specific therapy which is at stable dosing (i.e., not currently titrating therapy).
* NYHA class II-III symptoms.
* Able to complete a six-minute walk test.

Exclusion Criteria:

* Patients experiencing syncope or exertional syncope.
* Patients not experiencing exertional dyspnea.
* Inability to walk.
* Patients currently in pulmonary rehab or having completed pulmonary rehab within three months (unlikely to improve).

Primary outcomes:
measure: Adverse Events
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in EmPHasis-10 Quality of Life Survey
timeFrame: Baseline, 3 months
measure: Change in PAH-SYMPACT domain scores Quality of Life
timeFrame: Baseline, 3 months
measure: Change in self-management abilities
timeFrame: Baseline, 3 months
measure: Change in daily physical activity
timeFrame: Baseline, 3 months
measure: Change in exercise capacity
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Hilary DuBrock, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05323513: The Correlation Between Luteal Serum Progesterone and Live Birth Rate
Official title: The Correlation Between Luteal Serum Progesterone and Live Birth Rate in IVF - a Prospective Cohort Study (LUT-2)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility
Lead sponsor: Regionshospitalet Viborg, Skive
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated at The Fertility Clinic, Regional Hospital in Skive, who meets the inclusion criteria will be invited to participate in the study.

Brief summary: The study design is an observational cohort study. Level of serum P4 will be collected on day OR+4 as well as on the day of embryo transfer (ET) either day OR+3 or OR+5.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* BMI \<35kg/m2

Exclusion Criteria:

* No fresh embryo transfer
* Prior participation in the study

Primary outcomes:
measure: Live birth rate in relation to luteal serum progesterone levels on day four and three or five
timeFrame: 9-24 months after inclusion
Secondary outcomes:
measure: Pregnancy rate in relation to luteal serum progesterone levels
timeFrame: 14-16 days after oocyte retrieval
measure: Clinical pregnancy rate in relation to luteal serum progesterone levels
timeFrame: 7-9 weeks after inclusion
Other outcomes:
Locations:
city: Skive
country: Denmark
facility: Fertilitetsklinikken, Regionshospitalet Skive
Study officials:
affiliation: Fertilitetsklinikken, Regionshospitalet Skive
name: Peter Humaidan, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03084913: Olive Oil v Prostate Cancer Foundation Diet for Treatment of Prostate Cancer
Official title: Comparing Diets for Weight Loss and Improvement in Cancer Biomarkers in Men With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: dietary treatment
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 30
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study compared a plant-based, olive oil diet to the diet recommended by the Prostate Cancer Foundation for weight loss and improvement in some laboratory biomarkers.

Detailed description: Dietary treatment of overweight/ obese men with prostate cancer has not been well studied. As men with prostate cancer who are overweight/ obese are at an increase risk of recurrence, metastasis and mortality, elucidating a diet that will both improve biomarkers for prostate cancer and lead to long-term weight management could improve survivorship. The primary objective of this proposal is to compare a plant-based, olive oil (PBOO) diet to a conventional diet for weight loss and improvement in metabolic biomarkers (specifically fasting insulin, glucose, and triglycerides) for overweight/ obese men diagnosed with prostate cancer on surveillance or who have had an asymptomatic biochemical failure after primary therapy. The secondary objective is to determine which diet will be more acceptable for long term use. Participants will consume for 8 weeks each a conventional diet for treating prostate cancer and a PBOO diet for weight loss and improvement in biomarkers with random assignment to the diet order. They will choose one of the diets for 6 months of follow-up. Blood samples and body weight will be obtained pre- and post diet and after 6 months of follow-up and compared between the diets. Based on earlier work by colleagues of the PI, it is anticipated that the PBOO diet will result in better weight loss and biomarkers and will be more acceptable for long-term weight management. This protocol has the potential to elucidate a diet that will improve the body weight and survival of men with prostate cancer.

Eligibility criteria: Inclusion Criteria:

* prostate cancer, BMI 25.0 to 40.0 kg/m2

Exclusion Criteria:

-

Primary outcomes:
measure: weight loss
timeFrame: 8 weeks
Secondary outcomes:
measure: improvement in in fasting blood glucose and insulin
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Research Dietitian
name: Mary M Flynn, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: