louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04478318: Comparison of Imaging Characteristics of uEXPLORER and Conventional PET/CT in Patients With Lung Cancer, Lymphoma, and Melanoma
Official title: Quantitative Comparison of Imaging Characteristics of uEXPLORER and Conventional PET/CT in Patients With Lung Cancer, Lymphoma, and Melanoma Undergoing Standard-of-Care FDG-PET/CT for Initial Staging
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Lung Neoplasm
Lymphoma
Melanoma
Fluorodeoxyglucose
Positron-emission Tomography
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To determine the minimum scan duration for fluorine-18 positron-emitting radioactive isotope-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET)/computed tomography (CT) scans performed on a total-body PET/CT scanner that results in non-inferior image quality to 18F-FDG PET/CT scans performed on a conventional PET/CT scanner. The subject population will be patients being staged for lung cancer, lymphoma, or melanoma.


Eligibility criteria: Inclusion Criteria:

1. Ability to understand and willingness to sign an informed consent form.
2. Ability to adhere to the study visit schedule and all protocol requirements.
3. Men and women ≥18 years of age.
4. Diagnosis or suspected diagnosis of lung cancer, melanoma or lymphoma.
5. Patients who have been referred for a PET/CT scan.

Exclusion Criteria:

1. Pregnant women.
2. Claustrophobia.
3. Any significant medical condition that in the opinion of the investigator would prevent the subject from participating and/or adhering to study related procedures or interfere with subject safety.

Primary outcomes:
measure: Minimum scan duration on a total-body PET/CT scanner for quality
timeFrame: One imaging visit up to two hours
Secondary outcomes:
measure: Minimum scan duration on a total-body PET/CT scanner for tumor recognition
timeFrame: One imaging visit up to two hours
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis
state: California
Study officials:
affiliation: UC Davis Department of Radiology
name: Lorenzo Nardo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03906318: Expanded Access Use of Itacitinib to Treat a Single Patient With Aplastic Anemia
Official title: Expanded Access Use of Itacitinib to Treat a Single Patient With Aplastic Anemia
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Aplastic Anemia
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2019-04-08
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Expanded Access Use of Itacitinib to Treat a Single Patient With Aplastic Anemia


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Baylor College of Medicine - Texas Children's Hospital
name: Lisa Forbes Satter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosenberg JM, Peters JM, Hughes T, Lareau CA, Ludwig LS, Massoth LR, Austin-Tse C, Rehm HL, Bryson B, Chen YB, Regev A, Shalek AK, Fortune SM, Sykes DB. JAK inhibition in a patient with a STAT1 gain-of-function variant reveals STAT1 dysregulation as a common feature of aplastic anemia. Med. 2022 Jan 14;3(1):42-57.e5. doi: 10.1016/j.medj.2021.12.003.
Clinical trial NCT02692118: Inflammatory Mediators in Early Sepsis
Official title: Inflammatory Mediators in Sepsis as Indicator for Infection vs Inflammation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammation
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2016-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive Care patients with septic shock

Brief summary: Sepsis is still a challenge for clinicians since the detailed pathomechanism are still unknown and until now early markers for sepsis are not defined yet. Immunological pathways and new mediators defined in animal models are not yet investigated in patients with sepsis. Therefore the investigators will measure new mediators in patients with septic shock.

Detailed description: Semaphorins 1 to 7 will be determined in Blood of patients with early septic shock. Concentration will be compared with blood concentration of postoperative patients suffering systemic inflammatory response syndrome (SIRS).

Eligibility criteria: Inclusion Criteria:

* Septic Shock

Exclusion Criteria:

* Age \< 18 \> 85
* no consent of caregiver
* Trauma patients
* Burn patients
* Immunosuppression
* Pregnancy
* HIV- hepatitis infection

Primary outcomes:
measure: Semaphorin 1 to 7 in plasma of septic patients
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
Study officials:
affiliation: University Hospital Tuebingen
name: Peter Rosenberger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01541618: A Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis
Official title: A Longitudinal Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: MS
RRMS
RR Multiple Sclerosis
Lead sponsor: MSDx, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-01
Enrollment: 15
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study populations for this study is a patient with a diagnosis of relapsing remitting multiple sclerosis (RRMS) who is about to begin Natalizumab (Tysabri) therapy for a relapse in clinical symptoms (either diagnosed clinically or via gadolinium MRI).

Brief summary: The purpose of this study is to compare biomarker levels in Multiple Sclerosis (MS) patients before and after beginning Natalizumab.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of clinically definite relapsing remitting MS (RRMS)
2. Age 45 years and older
3. Willing and able to provide written informed consent
4. Patient has high disease activity.
5. Patient is about to begin Natalizumab (Tysabri) therapy.

Exclusion Criteria:

1. Any clinically significant disease other than MS that is likely to interfere with the evaluation of CDMS
2. Known infectious or hematological disease.
3. Unwilling or unable to comply with the requirements of this protocol
4. Subject can not have a gadolinium enhanced MRI

Primary outcomes:
measure: Change in MSDX Complex-1 between baseline and 6-month visit
timeFrame: 6 months
Secondary outcomes:
measure: Gadolinium MRI and MSDX Complex-1 level
timeFrame: 6 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Northwest NeuroSpecialists, PLLC
state: Arizona
Study officials:
affiliation: Northwest NeuroSpecialists, PLLC
name: Jeannette Wendt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01042418: Appetite Profile After Intake of Rye Breakfast Meal
Official title: Appetite Profile After Intake of Rye Breakfast Meal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity Prevention
Keywords: satiety
grain structure
rye
Lead sponsor: Swedish University of Agricultural Sciences
Sponsor class: OTHER
Collaborators: name: Lantmannen Research and Development
First posted: 2010-01-05
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Food structure influence metabolic response including appetite. Whole grain foods include a wide range of products; cracked or cut kernels, rolled flakes or milled to flour and used in foods such as breads, breakfast cereals and pasta.

Detailed description: The aim of the present study was to investigate if rye grain structure influence perceived appetite. A comparison of whole rye kernels and milled rye kernels were done in two study parts. In the first part the rye was served as porridge breakfasts and in the second one milled and whole kernels were included into bread breakfasts. In order to observe potential effects that would arise when the remains of the meal reaches the colon, the period of measurement was set to 8 h after intake of iso-caloric rye bread and rye porridge breakfasts.

A randomized, crossover design was used to compare the effects of iso-caloric breakfast meals on subjective appetite during 8 h after consumption.

Eligibility criteria: Inclusion Criteria:

* 20 and 60 years;
* body mass index (BMI) 18-27 kg/m2;
* habit of consuming breakfast, lunch and dinner every day
* willingness to comply with the study procedures

Exclusion Criteria:

* intake of medicine likely to affect appetite or food intake;
* any medical condition involving the gastrointestinal tract;
* eating disorder;
* smoking;
* consumption of more than three cups of coffee per day;
* change of body weight more than 10% three months prior to screening;
* consumption of any restricted diet such as vegan, gluten free, slimming etc.;
* pregnancy, lactation or wish to become pregnant during the study period

Primary outcomes:
measure: Subjective appetite (hunger, satiety, desire to eat)
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Isaksson H, Rakha A, Andersson R, Fredriksson H, Olsson J, Aman P. Rye kernel breakfast increases satiety in the afternoon - an effect of food structure. Nutr J. 2011 Apr 11;10:31. doi: 10.1186/1475-2891-10-31.
Clinical trial NCT01524718: Internal Fixation of Hip Fractures Using Intraoperative Simultaneous Two Axis View
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture Neck of Femur
Keywords: radiation
time surgery
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
Collaborators: name: Clalit Health Services
First posted: 2012-02-02
Enrollment: 60
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: Hip fractures are one of the most frequent operated fractures procedures in orthopedics, with a world wide annual incidence of approximately 1.7 million. These fractures are associated with substantial morbidity and mortality. As populations age and life expectancy increases worldwide, the incidence of these fractures is likely to raise, expected to triple in the next 50 years. The use of fluoroscopy and resultant exposure to radiation, is an integral part of surgical procedures aiming to reduce and fixate the fractured femur. The risk of contracting cancer is significantly higher for an orthopedic surgeon as Hip surgery is a major slice of the total radiation dose. Optimal positioning and control of the imaging intensifier device may result in significant reduction of radiation dose and time and in substantial shortening of the procedure.

The investigators hypothesis is that this technique would substantially shorten procedure time and reduce unnecessary radiation exposure for both the patient and the medical staff. Furthermore, by using this technique the investigators can eliminate the need for fluoroscopy technician during the surgery, as there is no need to alternate fluoroscopy views.


Eligibility criteria: Inclusion Criteria:

* patients with intertrochanteric femoral fracture who are going to be operated by closed reduction and internal fixation with an intramedullary nail.

Primary outcomes:
measure: Time of surgery
timeFrame: 5 hours - operation time
Secondary outcomes:
measure: X-ray time during surgery
timeFrame: 5 hours - operation time
measure: Accuracy of nail position
timeFrame: 5 hours - operation time
measure: Accuracy of reduction
timeFrame: 5 hours - operation time
Other outcomes:
Locations:
city: Kfar - Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT01571518: Prevention of Neutropenia After Using G-CSF With TAC Chemotherapy
Official title: Optimal Timing and Duration of Daily G-CSF With Adjuvant TAC Chemotherapy in Node-positive Breast Cancer;Multicenter, Randomized, Open Label, Clinically IV Phase
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Neutropenia
Keywords: G-CSF
neutropenia
TAC
Lead sponsor: Sunchonhang University
Sponsor class: OTHER
Collaborators: name: Dong-A Pharmaceutical Co., Ltd.
First posted: 2012-04-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: After resection of lymph node positive breast cancer, the injection duration and timing of Granulocyte-colony stimulating factor (G-CSF) could affect the neutropenia with TAC (Taxotere, Adriamycin, cyclophosphamide) chemotherapy.

Detailed description: The duration and the injection timing of G-CSF are effective in the prevention of neutropenia, incidence of infection and non hematologic toxicity. With the TAC chemotherapy after resection of breast cancer, the G-CSF early injection versus late injection could change the frequency of neutropenia.

Eligibility criteria: Inclusion Criteria:

* primary invasive breast carcinoma with lymph node positive with curative surgery with TAC chemotherapy

Exclusion Criteria:

* pregnancy,
* cardiovascualr disease,
* abnormal renal function,
* hematologic disorder

Primary outcomes:
measure: frequency of neutropenia
timeFrame: Change from Baseline in neutrophil count at 21days
Secondary outcomes:
Other outcomes:
Locations:
city: Puchun
country: Korea, Republic of
facility: Soonchunhyang university Puchun Hospital
Study officials:
affiliation: Soonchunhyang U Puchun Hospital
name: Chul Wan Lim, MD,PhD
role: STUDY_CHAIR
References:
citation: Chan A, Fu WH, Shih V, Coyuco JC, Tan SH, Ng R. Impact of colony-stimulating factors to reduce febrile neutropenic events in breast cancer patients receiving docetaxel plus cyclophosphamide chemotherapy. Support Care Cancer. 2011 Apr;19(4):497-504. doi: 10.1007/s00520-010-0843-8. Epub 2010 Mar 17.
Clinical trial NCT02287818: A Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Gout
Official title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF AC-201 IN SUBJECTS WITH GOUT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gout
Lead sponsor: TWi Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-11
Enrollment: 127
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to test the urate-lowering effect, safety, and tolerability of AC-201CR in an initial dosing period, followed by the addition of a ULT to test the efficacy and safety of the combination and prophylaxis of gout flares during ULT.

Detailed description: AC-201CR is a control released formulation of AC-201 that in previous clinical studies showed potential dual effects in both reducing serum uric acid (sUA) and gout flares. The mechanism of action of AC-201 includes the inhibition of the production and activity of caspase-1 and interleukin-1β (IL-1β), and selective inhibition of re-absorption transporters in the kidney. The goal of gout treatment is to reduce serum uric acid (sUA) concentrations below the urate solubility limit while avoiding acute gout flares. However, the initiation of urate-lowering therapy (ULT) increases the occurrence of acute gouty arthritis flares. IL-1β plays a key role in mediating this inflammatory response.

Eligibility criteria: Inclusion Criteria:

1. Male or female age 20 to 65 years, inclusive.
2. Meets ≥6 of the 12 American College of Rheumatology preliminary criteria (1977) for the classification of acute arthritis of primary gout (Appendix 2), OR have proven tophus or documented monosodium urate (MSU) crystals in the joint fluid.
3. Serum uric acid ≥7.5 mg/dL and ≤10 mg/dL at screening with ≥1 gouty arthritis flare within one year prior to screening, OR serum uric acid ≥9 mg/dL and ≤10 mg/dL at screening with or without prior gout flares.

Exclusion Criteria:

1. Use of allopurinol, febuxostat, benzbromarone, probenecid, or sulfinpyrazone within 2 weeks prior to screening.
2. Occurrence of a gouty arthritis flare within 1 week prior to screening or during the screening period through baseline.
3. Use of colchicine within 1 week prior to screening.
4. Use of Glucocorticoids, NSAIDs or COX-2 inhibitors within 1 week prior to screening.
5. Allergy, contraindication, or intolerance to febuxostat.
6. Severe renal impairment.
7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) concentration \>2 times the upper limit of laboratory normal range (\>2x ULN) at screening.

Primary outcomes:
measure: Proportion of Subjects Achieving Serum Uric Acid Concentration <6.0 mg/dL
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veteran General Hospital (TVGH)
Study officials:
affiliation: Taipei Veteran General Hospital (TVGH)
name: Chang-Youh Tsai
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05011318: Effects of Cognitive Fatigue on Heart Rate Variability and Skin Conductance
Official title: Effects of Cognitive Fatigue on Heart Rate Variability and Skin Conductance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Fatigue
Mental Fatigue
Behavioral Performance
Heart Rate Variability
Skin Conductance
Lead sponsor: Nanyang Technological University
Sponsor class: OTHER
Collaborators: name: National Research Foundation, Singapore
name: Ministry of National Development, Singapore
name: Housing and Development Board, Singapore
First posted: 2021-08-18
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to examine the effects of cognitive fatigue on heart rate variability and skin conductance and develop a machine learning model.

Detailed description: We hypothesize that increased cognitive fatigue would vary as a function of heart rate variability and skin conductance. A machine learning model will be developed that predicts cognitive fatigue through these physiological responses (Lee et al., 2021). Individual differences (i.e., age, gender, caffeine and food intake, body mass index, skin temperature, sleep quality, baseline physiology and behavioural performance) will be examined and accounted for.

Eligibility criteria: Inclusion Criteria:

* Singapore-based
* Non-clinical
* 18-35years

Exclusion Criteria:

* Individuals with hearing difficulties or failing to meet the minimal threshold for normal hearing
* Individuals with a history of ear, developmental, neurological, or psychiatric disorder

Primary outcomes:
measure: 2-Back Task (Change)
timeFrame: during fatigue manipulation
measure: 2-Back Task (Change)
timeFrame: during fatigue manipulation
measure: Fatigue State Questionnaire
timeFrame: up to 5 mins after fatigue manipulation
measure: Electrocardiograph (Change)
timeFrame: during fatigue manipulation
measure: Electrodermal Activity (Change)
timeFrame: during fatigue manipulation
measure: Electrodermal Activity (Change)
timeFrame: during fatigue manipulation
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Cultural Science Innovations, Nanyang Technological University
Study officials:
References:
citation: Lee KFA, Gan WS, Christopoulos G. Biomarker-Informed Machine Learning Model of Cognitive Fatigue from a Heart Rate Response Perspective. Sensors (Basel). 2021 Jun 2;21(11):3843. doi: 10.3390/s21113843.
Clinical trial NCT03836118: Intrauterine Insemination Predictor Factors
Official title: Retrospective Evaluation of Clinical Predictors of Pregnancy and Live-birth After Homologous Intrauterine Insemination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2019-02-11
Enrollment: 2970
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The included couples were subjected to an infertility diagnostic work-up. The tests included collecting medical history, physical examination, transvaginal ultrasound, serum hormone assays between day 2 and 4 of the menstrual cycle, semen analysis, uterine cavity and tubal patency evaluation with hysterosalpingography (HSG) or hysterosonosalpingography (HSSG) and/or hysteroscopy and video laparoscopy. Assessment of vaginal infection with cervico-vaginal swab and cultures

Brief summary: Multiple studies have reported on the impact of factors such as female age, duration of infertility, type of infertility, hormone levels (i.e. AMH, FSH, estradiol, progesterone), use of different ovarian stimulation protocols, timing/induction of ovulation, number of pre-ovulatory follicles, endometrial thickness by the time of ovulation, sperm parameters (i.e. concentration, progressive motility, morphology, total motile sperm count \[TMSC\], inseminating motile count \[IMC\]) and sperm washing procedures. Also the influence of body mass index and smoking on IUI outcome have been studied before. However, results on the predictive value of these parameters remain highly contradictory. The aim of the study is to examine the value of different variables in the prediction of IUI success to develop a clinically useful predictive model of pregnancy and live birth.


Eligibility criteria: Inclusion Criteria:

* couples had been diagnosed with infertility according to WHO definition (failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse)
* at least one permeable tube
* a motile sperm concentration post treatment of 1×106/mL on the day of the semen analysis

Primary outcomes:
measure: clinical pregnancy rate (CPR)
timeFrame: 1997-2017
measure: live-birth rate (LBR)
timeFrame: 1997 - 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Paolo Emanuele Levi Setti
state: MI
Study officials:
References:
citation: Immediata V, Patrizio P, Parisen Toldin MR, Morenghi E, Ronchetti C, Cirillo F, Baggiani A, Albani E, Levi-Setti PE. Twenty-one year experience with intrauterine inseminations after controlled ovarian stimulation with gonadotropins: maternal age is the only prognostic factor for success. J Assist Reprod Genet. 2020 May;37(5):1195-1201. doi: 10.1007/s10815-020-01752-3. Epub 2020 Mar 25.