louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04620655: RD13-01 for Patients With r/r CD7+ T-ALL/T-LBL
Official title: RD13-01 for Patients With r/r CD7+ T-ALL/T-LBL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: T Acute Lymphoblastic Leukemia
T-lymphoblastic Lymphoma
Lead sponsor: Hebei Yanda Ludaopei Hospital
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 24
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to explore the safety of RD13-01 for patients with CD7+ relapsed and/or refractory T cell acute lymphoblastic leukemia or lymphoblastic lymphoma. And to evaluate the efficacy and pharmacokinetics of RD13-01 in patients.


Eligibility criteria: Inclusion Criteria:

1. Aged 3 to 70 years.
2. Diagnosis of r/r T-ALL/T-LBL.
3. ECOG: 0-2.
4. Life expectancy greater than 12 weeks.
5. Cardiac left ventricle ejection fraction ≥50%.
6. Informed consent explained to, understood by and signed by the patient/ guardian. Patient/guardian is given a copy of informed consent.

Exclusion Criteria:

1. Pregnant or lactating.
2. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Viral (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA positive; syphilis positive.
3. Patients with graft-versus-host disease (GVHD) or who need to use immunosuppressive drugs.
4. Participated in other clinical studies within 2 weeks prior to screening.
5. History of alcoholism, drug abuse or mental illness.
6. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Primary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: 4 weeks after infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Langfang
country: China
facility: Hebei Yanda Ludaopei Hospital
state: Hebei
Study officials:
affiliation: Hebei Yanda Ludaopei Hospital
name: Xian Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03515655: A Study of Patients Hospitalized With Acute Heart Failure With Reduced Ejection Fraction (HFrEF)
Official title: Characterizing Acute Heart Failure With Reduced Ejection Fraction Hospitalization Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-05-03
Enrollment: 99209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be patients who were hospitalized with acute heart failure with an average reduced ejection fraction≤40during hospitalization, and who do not have a coincident myocardial infarction and who have at least 6 months of activity in the database prior to the hospitalization.

Brief summary: A study of participants hospitalized with acute heart failure with reduced ejection fraction


Eligibility criteria: Inclusion Criteria:

* An average left ventricular ejection fraction (LVEF) \< 40% over the entire index hospitalization
* Age 18 years or older on the index date
* At least 6 months of activity in the databaseprior to the index date

Exclusion Criteria:

* Any code for myocardial infarction (ICD-9 diagnosis code: 410.xx, ICD-10 diagnosis code: I21.xx) or related terms such as "myocardial infarction", "mi", "infarct" or "heart attack" occurring during the index hospitalization

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Incidence of 30 day mortality
timeFrame: 30 days
measure: Incidence of 30 day readmission
timeFrame: 30 days
measure: Incidence of a prolonged length of stay
timeFrame: 30 days
measure: Incidence of participants hospitalized with AHF with reduced ejection fraction
timeFrame: 6 years
Secondary outcomes:
measure: Distribution of socio-demographic characteristics in participants hospitalized for acute HFrEF
timeFrame: 6 years
measure: Distribution of clinical characteristics in participants hospitalized for acute HFrEF
timeFrame: 6 years
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Local Institution
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04954755: Development and Validation of a Prediction Model for Refeeding Syndrome in ICU Patients Undergoing Enteral Nutrition Patients
Official title: Development and Validation of a Prediction Model for Refeeding Syndrome in ICU Patients Undergoing Enteral Nutrition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Development and Validation of a Prediction Model for Refeeding Syndrome in ICU Patients Undergoing Enteral Nutrition
Keywords: Refeeding Syndrome;Enteral Nutrition;Prediction;Intensive Care
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 553
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Modeling queue: Relevant information of 433 patients who received enteral nutrition from January 2018 to July 2020 in ICU of a tertiary hospital in Zhejiang .

Authentication queue: Relevant information of 120 patients who received enteral nutrition from August 2020 to October 2020 in ICU of four tertiary hospitals in Zhejiang .

Brief summary: This study intends to strengthen the discussion on the risk factors of RFS in critically ill patients, and construct an RFS risk prediction model which is easy for clinical medical staff to use and has a high sensitivity and specificity; In order to help medical staff to identify the high-risk groups of RFS in critically ill patients efficiently and accurately, and take targeted care and treatment for patients, so as to reduce the adverse consequences of RFS on critically ill patients.


Eligibility criteria: Inclusion Criteria:

* (1) Age ≥18 years old; (2) Patients with mechanical ventilation; (3) First admission to ICU； (4) The time of receiving enteral nutrition support in ICU was ≥ 3 days.

Exclusion Criteria:

* (1)Ppregnant women or lactating patients;(2) Patients with incomplete information;(3) There are other risk factors leading to hypophosphatemia, such as continuous hemodialysis , hyperphosphatemia treatment,Parathyroid gland resection was performed within 3 months.

Primary outcomes:
measure: Occurrence of RFS
timeFrame: from December 1, 2019 to October 31, 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: Development and Validation of a Prediction Model for Refeeding Syndrome in ICU Patients Undergoing Enteral Nutrition
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Meiqi Yao, undergraduate
role: STUDY_CHAIR
affiliation: Huzhou University
name: Xingxia Long, postgraduate
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02863614: Analgesia for Endometrial Scratching
Official title: Analgesia for Endometrial Scratching in Subfertile Women: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subfertility
Infertility
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate whether Ibuprofen alone or combined with lorazepam reduce the pain associated with endometrial scratching/injury.


Eligibility criteria: Inclusion Criteria:

* Women aged ≥ 18 years undergoing assisted reproduction (IUI, IVF/ICSI, frozen embryo transfer)
* Being submitted to endometrial scratching/injury with a Pipelle on the first four days of the menstrual cycle.
* Not have performed endometrial scratching in the last 90 days.

Exclusion Criteria:

- None

Primary outcomes:
measure: Maximum pain during procedure
timeFrame: 5 minutes
Secondary outcomes:
measure: Pain after the procedure
timeFrame: 5 minutes
measure: Rejection to a new procedure
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00900614: Safety Study of APR-246 in Patients With Refractory Hematologic Cancer or Prostate Cancer
Official title: An Open-label Phase I Dose Escalating Study of APR-246 for Infusion in Patients With Refractory Hematologic Malignancies or Prostate Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hematologic Neoplasms
Prostatic Neoplasms
Keywords: Hematologic malignancy
Prostate carcinoma
Hematologic cancer
Prostate cancer
Lead sponsor: Aprea Therapeutics
Sponsor class: INDUSTRY
First posted: 2009-05-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the highest feasible dose (HFD) of intravenous (IV) APR-246 when given to patients with refractory hematologic malignancies or prostate carcinoma.


Eligibility criteria: Summary criteria for participant selection:

Inclusion Criteria:

* Male or female ≥ 18 years of age.
* Any below mentioned advanced disease, which is not eligible for other therapies. The diagnosis should have been confirmed either histologically or cytologically:

  1. Acute myeloid leukemia.
  2. Acute lymphoid leukemia.
  3. Chronic lymphocytic leukemia.
  4. Chronic myeloid leukemia.
  5. Chronic myelomonocytic leukemia.
  6. Multiple myeloma.
  7. Non Hodgkin's lymphoma.
  8. Hodgkin's lymphoma.
  9. Myelodysplastic syndrome.
  10. Myelofibrosis.
  11. Hormone refractory, metastatic prostate carcinoma.

Primary outcomes:
measure: Dose-Limiting Toxicity (DLT) is reached and HFD is defined accordingly, OR the dose, which is expected to result in maximum plasma concentration close to, but not exceeding 35 μg/ml in any single patient without showing signs of DLT.
timeFrame: 21 days
Secondary outcomes:
measure: Determination of the toxicity and safety profile of APR-246 based on safety parameters from the entire study period.
timeFrame: continuously during 21 days
measure: Determination of the PK profile for up to 22 hours after the last APR-246 infusion. Cmax (maximal plasma concentration), AUC (area under the curve), t1/2 (half-life) and clearance will be determined.
timeFrame: continuously, during 21 days
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Section of Haematology and Coagulation, Sahlgrenska University Hospital
city: Stockholm
country: Sweden
facility: Hematology Centre, M54, Karolinska Institute, Karolinska University Hospital, Huddinge
city: Uppsala
country: Sweden
facility: Clinical Research and Development Unit, Department of Oncology, Akademiska Hospital
city: Uppsala
country: Sweden
facility: Department of Haematology, Akademiska Hospital
city: Örebro
country: Sweden
facility: Department of Hematology, University Hospital
city: Örebro
country: Sweden
facility: Urology clinic, University Hospital
Study officials:
affiliation: Hematology Centre, M54, Karolinska Institute, Karolinska University Hospital, Huddinge, SE-141 86, Stockholm, Sweden
name: Sören Lehmann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02888314: Pokemon Go and Physical Activity
Official title: Pokemon Go and Physical Activity Online Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Activity
Keywords: mHealth
Pokemon Go
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 167
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who use iPhone and have played Pokemon Go before July 31, 2016

Brief summary: The goal of this study to evaluate the association between Pokemon Go and physical activity through a survey among Pokemon Go players.

Detailed description: Pokemon Go is a location-based reality mobile game for iOS and Android devices developed by Niantic. Making use of GPS and the camera of compatible devices, the game allows players to capture virtual creatures, called Pokemon, who appear on cellphone screens as though in the real world. In order to search and capture the Pokemon, the players needs to go out and become more active. For this reason, the game has great potential to promote physical activity. Nevertheless, there has no study evaluating the potential impact of Pokemon Go on physical activity. The investigator proposes a retrospective online survey. Participants are instructed to enter data of their daily physical activity as reported in iPhone Health App. Number of "Steps" and % greater than 10,000 steps/day will be compared before and after installing the Pokemon Go app.

Eligibility criteria: Inclusion Criteria:

* Subjects who use iPhone and have played Pokemon Go before July 31, 2016 and agree to consent to participate in the survey

Exclusion Criteria:

* Subjects who do not use iPhone
* Have not played Pokemon Go before July 31, 2016
* Unable to provide informed consent

Primary outcomes:
measure: Average number of steps per day
timeFrame: Between June 15 and July 31, 2016
measure: Change in number of steps after Pokemon Go
timeFrame: From June 15 to July 31, 2016, assessed up to 6 weeks
Secondary outcomes:
measure: Greater than 10,000 steps per day
timeFrame: Between June 15 and July 31, 2016
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Ying Ying, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xian Y, Xu H, Xu H, Liang L, Hernandez AF, Wang TY, Peterson ED. An Initial Evaluation of the Impact of Pokemon GO on Physical Activity. J Am Heart Assoc. 2017 May 16;6(5):e005341. doi: 10.1161/JAHA.116.005341.
Clinical trial NCT02707614: Why in PACU After Prostastectomy 2016
Official title: Perioperative Mechanisms for Postoperative Function - the Case of Prostastectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perioperative, Enhanced Recovery
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2016-03-14
Enrollment: 120
Sex: MALE
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: The study includes male patients with prostate cancer that will undergo surgery regarding removal or staging of their prostate cancer. The stage of the disease is insignificant, however the patients preoperative physical state for surgery will be registrered in detailed such as comorbidities, height, weight, bloodpressure and blood test results.

Brief summary: This study aims to describe the postoperative functions of patients after undergoing open or robotic prostastectomy. Primary endpoints will focus on complications in the post-anaesthesia care unit (PACU) which prevent dischard from PACU to the general ward. This include Aldrete scores and other complications that can be registrered descriptively. Furthermore, the study seeks to compare what influence open versus robotic prostastectomy have on peri- og postoperative complications.


Eligibility criteria: Inclusion Criteria:

* Histology diagnosis of prostate cancer
* Surgery intended for removal or staging of prostate cancer: open prostatectomy, robotic prostastectomy, open staging surgery, laparoscopic staging surgery.

Exclusion Criteria:

* Patients with prostate cancer that do not have surgery.
* Surgery regarding only removal of distant mestatases origined from prostate cancer.

Primary outcomes:
measure: Complications
timeFrame: up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, abdominal center
Study officials:
affiliation: Rigshospitalet, Denmark
name: Eske K Aasvang, DMSci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04913714: 10+10+30 Infant Vaccines Communication Via Radio in Ethiopia
Official title: 10+10+30 Infant Vaccines Communication Via Radio in Ethiopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant ALL
Lead sponsor: Syracuse University
Sponsor class: OTHER
Collaborators: name: Jimma University
name: Texas A&M University
name: Bill and Melinda Gates Foundation
First posted: 2021-06-04
Enrollment: 1320
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A cohort study to investigate the effectiveness of radio intervention comprising 10-minute of drama, 10-minute of discussion led by community extension workers, and 30-minute phone-in from listeners on childhood vaccination coverage and timeliness

Detailed description: The evaluation is conducted in 2 districts located in the Oromia region of Ethiopia. One of the districts will be allocated to receive the 3-month radio intervention while the other district that will not have access to the radio intervention will serve as the control.

Data collection includes survey of mothers at two "key" times: at baseline (when infants are at most 5 weeks old; but before beginning the intervention) and at endline (including examination of infant vaccination records) at most 21 days after the end of the radio intervention. The same mothers and infants to be followed at endline.

Eligibility criteria: Inclusion Criteria:

Mother, with infant of at most 5 weeks old; Lives in the study district; Consents to participate in study

Exclusion Criteria:

Mother, with infant of more than 5 weeks old; Does not live in study district; Does not consent to participate in study

Primary outcomes:
measure: Penta 3 vaccine coverage of infant
timeFrame: up to 3 weeks after the intervention ends
Secondary outcomes:
measure: Timeliness of infant vaccines
timeFrame: up to 3 weeks after the intervention ends
measure: Full coverage of infant vaccines
timeFrame: up to 3 weeks after the intervention ends
measure: Perceived barriers to vaccination
timeFrame: Immediately before intervention starts, and up to 3 weeks after the intervention ends
measure: Perceived susceptibility to vaccine-preventable diseases in children
timeFrame: Immediately before intervention starts, and up to 3 weeks after the intervention ends
measure: Perceived benefits of infant vaccines
timeFrame: Immediately before intervention starts, and up to 3 weeks after the intervention ends
measure: Perceived severity of vaccine-preventable diseases in children
timeFrame: Immediately before intervention starts, and up to 3 weeks after the intervention ends
measure: Cues to action
timeFrame: Immediately before intervention starts, and up to 3 weeks after the intervention ends
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Syracuse University
state: New York
city: Jimma
country: Ethiopia
facility: Jimma University
Study officials:
affiliation: Syracuse University
name: Bernard Appiah, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04090814: TENS Reduces Movement-Evoked Pain in People With CLBP
Official title: Transcutaneous Electrical Nerve Stimulation Reduces Movement-Evoked Pain in People With Chronic Low Back Pain: A Randomised Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 25
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this cross-over study 25 patients with chronic low back pain (CLBP) were tested for pain relief in 2 conditions: while using the Transcutaneous Electrical Nerve Stimulation (TENS) application and without using it. Primary outcome: Movement-Evoked Pain (MEP). This was measured using the Back Performance Scale (BPS) and a 5-minute walk test (5MWT). Participants performed 5 functional tasks and were asked to rate their pain before, during, and after each movement on a numeric rating score scale. The same principle will be used for the 5MWT: for each walking-minute, 3 pain measurements will be assessed.


Eligibility criteria: Inclusion Criteria:

* chronic nonspecific LBP for at least 3 months' duration: non-specific LBP implies that patients are not allowed to have any evidence of specific spinal pathology (e.g., hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture or malignancy).

Exclusion Criteria:

* spinal surgery in the past 6 months
* severe underlying comorbidity (like diagnosed diabetes, cardiovascular problems, etc.),
* pregnant or given birth in the preceding year,
* having initiated a new LBP treatment in the 6 weeks prior to study participation

Primary outcomes:
measure: Movement Evoked Pain
timeFrame: Change in pain score between (1) Movement Evoked Pain measures assessed without TENS application and (2) Movement-Evoked Pain measured assessed while using TENS application. Between both measures, a wash out period of 30 minutes was introduced.
Secondary outcomes:
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Vrije Universiteit Brussel
state: Jette
Study officials:
affiliation: Dra. Lynn Leemans
name: Lynn Leemans
role: PRINCIPAL_INVESTIGATOR
References:
citation: Srikandarajah S, Gilron I. Systematic review of movement-evoked pain versus pain at rest in postsurgical clinical trials and meta-analyses: a fundamental distinction requiring standardized measurement. Pain. 2011 Aug;152(8):1734-1739. doi: 10.1016/j.pain.2011.02.008. Epub 2011 Mar 12.