louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02966444: Hunger, Satiety, and Metabolic Responses to High-fat Meals of Varying Fatty Acid Composition
Official title: Hunger, Satiety, and Metabolic Responses to High-fat Meals of Varying Fatty Acid Composition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Body Weight Changes
Lead sponsor: Texas Christian University
Sponsor class: OTHER
First posted: 2016-11-17
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study evaluates the effects of dietary fatty acid composition from high fat meals on markers of hunger, satiety and metabolism.


Eligibility criteria: Inclusion Criteria:

* BMI of \>18.5-24.9kg/m2
* Woman
* 18-40yrs of age

Exclusion Criteria:

* Evidence of weight loss or gain exceeding 5% of their body weight within the past 3 months.
* Plans to lose weight or begin a weight loss program between initiation of study and final testing.
* Plans to begin an exercise program or change current exercise routines between initiation of study and final testing.
* Is on a medically prescribed diet
* Does not consume breakfast regularly
* Rate less than 80% of foods offered in the buffet at 50mm or more on the 100mm VAS as palatable
* Medications that could influence appetite or sensory function
* Reports of metabolic or endocrine disease, gastrointestinal disorders, or history of medical or surgical events that could affect fat digestion and hormone signaling.
* Any chronic disease including type II diabetes, hypothyroidism, hyperthyroidism, cardiovascular disease, and cancer
* Any supplements that a subject begins taking between initiation of study and final testing.
* Anyone who is currently pregnant, lactating, or planning on becoming pregnant before the conclusion of this study.
* Anyone who has allergies to any of the components of the liquid meals
* Anyone who has donated blood in the last 20 days

Primary outcomes:
measure: Peptide-YY
timeFrame: 18 months
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: 18 months
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Texas Christian University
state: Texas
Study officials:
affiliation: Texas Christian University
name: Jada L Stevenson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02698644: Hysteroscopic Tubal Occlusion With the Use of Iso Amyl-2-cyanoacrylate
Official title: Hysteroscopic Tubal Occlusion With the Use of Iso Amyl-2-cyanoacrylate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Fallopian Tube Occlusion
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 25
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Is to assess the effectiveness of hysteroscopic tubal application of Iso Amyl-2-cyanoacrylate in occluding uterine tubes of women, which would make it an easy approach for occluding tubes with hydrosalpinx prior to IVF and in tubal sterilization.

Detailed description: The study will be conducted according to the guidelines on human experimentation of the 1975 Declaration of Helsinki. For all patients after taking signed informed consent , transcervical hysteroscopic cannulation of the proximal one centimeter of both fallopian tubes, will be done using a 5 Fr, 42cm long, polyethylene ureteric catheter, where 0.5 ml of Iso Amyl-2-cyanoacrylate (AMCRYLATE®) will be injected in each side.

All the surgical procedures will be performed without anesthesia, only premedication with an NSAID (e.g. NaproxenR) is given orally one hour before the procedure.

Each patient will be under close observation for the first 24 hours postprocedure for any signs of inflammation as abdominal pain, tenderness or fever and for the vital data.

Total abdominal hysterectomy and bilateral salpingoophorectomy will be done, second day, a week, two weeks and three weeks and four weeks after injection,. Hysterectomy samples will be sent to histopathologist to assess the degree of tubal occlusion and the extent and the severity of inflammation in the tubal wall.

Eligibility criteria: Inclusion Criteria:

* patients planned for abdominal hysterectomy with well seen tubal ostia through hysteroscope

Exclusion Criteria:

* Any patient with Upper or lower genital tract infection as evidenced by fever, lower abdominal pain or tenderness and abnormal vaginal discharge will be excluded from the study

Primary outcomes:
measure: fallopian tube obstruction
timeFrame: from one day to four weeks
Secondary outcomes:
measure: degree and extend of inflammation in the fallopian tubes
timeFrame: from one day to four weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AIn Shams University Maternity Hospital
Study officials:
affiliation: Ain Shams University maternity hospital
name: Mohamed I Amer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02684344: Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention
Official title: Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post-Operative Urinary Retention
Keywords: Post-Operative Urinary Retention
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2016-02-18
Enrollment: 5
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized open-label study will be comprised of 2 cohorts: one control group and one treatment group. The trial will be conducted as an open label randomized trial to evaluate the efficacy of tamsulosin in the prevention of post-operative urinary retention. The study will include pre- and post-surgical evaluations of patients including symptoms of urinary retention and any adverse effects contributable to the study medication.


Eligibility criteria: Inclusion Criteria:

* Any male age 40 or older
* Scheduled to undergo one of the planned surgeries (thoracic, general, or urologic)
* Ability to give informed consent

Exclusion Criteria:

* Current use of alpha blocker
* Current use of a strong CYP 3A4 inhibitors
* Any allergy to tamsulosin, alpha-blocker medication class, or anaphylaxis allergy to sulfate containing medications
* Patients with any upcoming surgery for cataracts
* Currently enrolled in a clinical trial
* Inability to give informed consent

Primary outcomes:
measure: Number of Participants With Post-operative Urinary Retention
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Edward E. Messing, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00739544: Chronic Pain After Operation for Breast Cancer
Official title: Examination of Healthy Female Subjects in the Project: Disposing Factors for Chronic Pain After Operation for Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Pain Threshold
Keywords: Reference Values
Sensory Thresholds
Pain Threshold
Breast Neoplasms
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Breast Cancer Cooperative Group
name: Danish Cancer Society
First posted: 2008-08-21
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to identify intraindividual as well as iatrogenic factors disposing for the development of chronic and acute pains after surgery for breast cancer in order to improve treatment and prevent the development of acute and chronic postoperative pains.

Detailed description: Surgery for breast cancer is followed by acute undesirable sequelae (pain, nausea, vomiting, psycho-social adaptation) and late sequelae with discomfort or more severe neuropathic pain problems in the surgical area due to nerve damage or adjuvant-/radiotherapy. The late sequelae occur in 30-50% of patients but the exact mechanisms (preoperative disposing factors, intraoperative nerve damage/inflammatory response), acute postoperative pain and psychosocial factors remain to be determined in large, detailed, well-described studies, including stratification to modern breast cancer treatment (sentinel node strategy/ radiotherapy/ chemotherapy). The present study will describe in detail preoperative psychosocial/genetic pain mechanisms, intraoperative technique, multi-modal anaesthesia and opioid-reduced analgesia with a detailed, early and late postoperative follow-up with neurophysiological assessment in the surgical area and randomised studies on preventive therapy.

Eligibility criteria: Inclusion Criteria:

* Healthy women

Exclusion Criteria:

* Pregnancy
* Lactating

Primary outcomes:
measure: Reference values on: Cold and cold detection threshold,Paradoxical heat sensation,Thermal sensory limen procedure,Cold and heat pain threshold,Mechanical detection and pain threshold and sensitivity,Vibration detection threshold,Pressure pain threshold
timeFrame: From 08-20-2008 to 11-1-2008 test is performed two times with app one week in between
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Breast Surgery, Centre of Head and Orthopaedics, Rigshospitalet (university of Copenhagen)
Study officials:
affiliation: Department of Breast Surgery, Centre of Head and Orthopaedics, Rigshospitalet (University of Copenhagen), Denmark
name: Niels Kroman, MD, DMSc
role: STUDY_DIRECTOR
affiliation: Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet (University of Copenhagen), Denmark
name: Henrik Kehlet, MD Ph.D DMSc
role: STUDY_CHAIR
References:
Clinical trial NCT03192644: The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) Versus Adjuvant Transarterial Chemoembolization (TACE) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.
Official title: The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) Versus Adjuvant Transarterial Chemoembolization (TACE) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-06-20
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the impact on recurrence risk of adjuvant TAI and adjuvant TACE for patients with HCC and PVTT after hepatectomy.


Eligibility criteria: Inclusion Criteria:

* older than 18 years old and younger than 75 years;
* ECOG PS\<3;
* proven hepatocellular carcinoma with PVTT according pathological examination;
* not previous treated for tumor;
* tumor and tumor thrombosis were removed in operation;
* no recurrence occurence at 4 to 7 weeks after surgery;
* the lab test could meet: neutrophil count≥1.5×109/L; hemoglobin≥80g/L; platelet count≥60×109/L; serum albumin≥28g/L; total bilirubin\<3-times upper limit of normal; ALT\<5-times upper limit of normal; AST\<5-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 6 seconds; INR≤2.3;
* sign up consent;
* unrolled by other clinical trials about hepatocellular carcinoma.

Exclusion Criteria:

* cannot tolerate TACE or TAI;
* CNS or bone metastasis exits;
* known history of other malignancy;
* be allergic to related drugs;
* underwent organ transplantation before;
* be treated before (interferon included);
* known history of HIV infection;
* known history of drug or alcohol abuse;
* have GI hemorrhage or cardiac/brain vascular events within 30 days;
* pregnancy;

Primary outcomes:
measure: recurrence-free survival (RFS)
timeFrame: From date of randomization until the date of recurrence, assessed up to 60 months
Secondary outcomes:
measure: recurrence rate
timeFrame: 1 year, 2 year, 3 year, 5 year after surgery
measure: Overall survival (OS)
timeFrame: From date of randomization until the date of death from any cause, assessed up to 60 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center of Sun Yat-Sen University
Study officials:
References:
Clinical trial NCT01844544: Drug Related Problems Among Patients With Femoral Neck Fractures in an Orthopedic Ward
Official title: Identification and Characterization of Drug Related Problems Among Patients With Femoral Neck Fractures in an Orthopedic Ward
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoral Neck Fractures
Keywords: drug related problems
clinical pharmacist
femoral neck fractures
orthopedic patients
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2013-05-01
Enrollment: 104
Sex: ALL
Minimum age (years): 64
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over the age of 65 after a femoral neck fracture that are hospitalized in the orthopedic department at "Meir" medical center

Brief summary: the purpose of the study is to:

1. Identify and characterize drug related problems in patients after a femur neck fracture that are hospitalized in the orthopedic department at "Meir" medical center.
2. Evaluate the contribution of a clinical pharmacist in identifying,characterizing and preventing drug related problems in patients after a femur neck fracture that are hospitalized in the orthopedic department at "Meir" medical center.


Eligibility criteria: Inclusion Criteria:

* patients over 64
* patients after a femoral neck fracture
* patients hospitalized in the orthopedic ward at "Meir" medical center
* patients who speak Hebrew, Russian or English

Exclusion Criteria:

* patients under 64
* patients without a femoral neck fracture
* patients who don't speak Hebrew, Russian or English

Primary outcomes:
measure: Evaluate the overall number of drug related problems in patients with a femur neck fracture in the orthopedic department
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar - Saba
country: Israel
facility: Meir medical center
Study officials:
References:
Clinical trial NCT06258044: The Application Value of Deep Learning-Based Nomograms in Benign-Malignant Discrimination of TI-RADS Category 4 Thyroid Nodules
Official title: The Application Value of Deep Learning-Based Nomograms in Benign-Malignant Discrimination of TI-RADS Category 4 Thyroid Nodules
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Nodule
Keywords: TI-RADS category 4 thyroid nodules
YOLOv3 model
nomograms
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 500
Sex: ALL
Minimum age (years): 23
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study collected data on a total of 500 TI-RADS category 4 thyroid nodules from 500 patients who attended the First Affiliated Hospital of Shandong First Medical University from April 2022 to November 2023.

Brief summary: This retrospective study focuses on benign and malignant classification of thyroid nodules using deep learning techniques and evaluates the value of deep learning based nomograms in the classification of TI-RADS category 4 thyroid nodules to improve the accuracy of benign and malignant identification of TI-RADS category 4 thyroid nodules.

Materials and methods: Patients who visited in The First Affiliated Hospital of Shandong First Medical University ＆ Shandong Provincial Qianfoshan Hospital were collected. Their general clinical features, information on preoperative ultrasound diagnosis, and postoperative pathologic data were reviewed.


Eligibility criteria: Inclusion Criteria:

1. Ultrasound-confirmed diagnosis of thyroid nodules that are classified as TI-RADS category 4.
2. Availability of pathological results.

Exclusion Criteria:

1. Lack of pathological diagnosis.
2. History of thyroid surgery or other treatments.
3. Poor quality of ultrasound images of thyroid nodules.
4. Incomplete clinical and imaging data of the patient.

Primary outcomes:
measure: deep learning prediction model（YOLOv3） and the model evaluation
timeFrame: Immediately evaluated after the prediction model was built
measure: nomogram prediction and assessment
timeFrame: Immediately evaluated after the nomogram was built
measure: Selection of clinical features and assessment
timeFrame: After the dataset is collected and pathology results are obtained, the statistical results obtained are analyzed for clinical factors, averaging about 1 year.
measure: Impact and assessment of ultrasound grading
timeFrame: The graded results of the ultrasound examination were analyzed after the data set collection was completed, the ultrasound examination was completed and the final pathology results were obtained, on average about 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: QianfoshanH
state: Shandong
Study officials:
References:
Clinical trial NCT00099944: Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 Diabetes
Official title: Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: type 2 diabetes
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-12-22
Enrollment: 515
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: TREATMENT

Brief summary: Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to glimepiride in people with type 2 diabetes not at target blood glucose levels on a sulfonylurea alone.


Eligibility criteria: Inclusion Criteria:

* Blood glucose criteria must be met
* Previously treated with a sulfonylurea for at least 3 months
* Body mass index (BMI) in the range 22-45

Exclusion Criteria:

* Type 1 diabetes
* Pregnancy or lactation
* Evidence of serious cardiovascular complications
* Evidence of serious diabetic complications
* Laboratory value abnormalities as defined by the protocol
* Known sensitivity to glimepiride
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in HbA1c after 24 weeks
Secondary outcomes:
measure: Change from baseline in fasting plasma glucose at 24 weeks
measure: Patients with endpoint HbA1c <7% after 24 weeks
measure: Patients with reduction in HbA1c >/=to 0.7% after 24 weeks
measure: Adverse event profile after 24 weeks of treatment
measure: Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs. low baseline HbA1c
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Garber AJ, Foley JE, Banerji MA, Ebeling P, Gudbjornsdottir S, Camisasca RP, Couturier A, Baron MA. Effects of vildagliptin on glucose control in patients with type 2 diabetes inadequately controlled with a sulphonylurea. Diabetes Obes Metab. 2008 Nov;10(11):1047-56. doi: 10.1111/j.1463-1326.2008.00859.x. Epub 2008 Feb 18.
Clinical trial NCT05180344: Feasibility, Acceptability, and Preliminary Efficacy of a Novel Personalized Mobile Intervention for Suicide - Open Trial (2)
Official title: Feasibility, Acceptability, and Preliminary Efficacy of a Novel Personalized Mobile Intervention for Suicide
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide
Suicide and Self-harm
Suicide, Attempted
Suicidal Ideation
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: American Foundation for Suicide Prevention (AFSP)
First posted: 2022-01-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary aim of this grant is to conduct pilot testing on a novel personalized mobile intervention for suicide - Mobile Application to Prevent Suicide (MAPS) - and to establish feasibility, acceptability, safety, and primary outcomes (i.e., suicidal ideation and behavior; re-hospitalization).


Eligibility criteria: Inclusion Criteria:

* Suicidal ideation and/or suicidal behavior in the past month verified by the C-SSRS
* Between the ages of 18 and 26
* English proficiency
* Comfortable with smartphone technology
* Deemed by the treatment team to be stable enough to complete study procedures

Exclusion Criteria:

* Current psychotic or manic symptoms severe enough to interfere with study procedures

Primary outcomes:
measure: Acceptability of Research (Recruitment)
timeFrame: Baseline
measure: Acceptability of Research (Recruitment)
timeFrame: 1 month
measure: Acceptability of Research Procedures
timeFrame: 1 month
measure: Patient Satisfaction
timeFrame: 1 month
measure: Acceptability of MAPS Intervention
timeFrame: 1 month
measure: Satisfaction with MAPS Intervention
timeFrame: 4 weeks
measure: Ecological Momentary Assessment (EMA) Adherence
timeFrame: 4 weeks
Secondary outcomes:
measure: Suicidal Ideation and Behavior
timeFrame: 1 month
measure: Rehospitalization
timeFrame: 1 month
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
References: