louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01795378: Safety and Efficacy Study of Donor Natural Killer Cells Given After Haploidentical Hematopoietic Cell Transplantation
Official title: HLA-Haploidentical Hematopoietic Cell Transplantation and Subsequent Donor Natural Killer Cell Infusion in Refractory Acute Leukemia - A Phase 1-2a STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Myelogenous Leukemia
Acute Lymphoblastic Leukemia
Keywords: acute myelogenous leukemia
acute lymphoblastic leukemia
donor natural killer cells
HLA-haploidentical hematopoietic cell transplantation
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Korea Research Institute of Bioscience & Biotechnology
First posted: 2013-02-20
Enrollment: 56
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The protocol treatment is to evaluate clinical effects of donor-derived natural killer cells that are given after HLA-mismatched hematopoietic cell transplantation.

Detailed description: Those patients with acute leukemia, which is not responding to coventional chemotherapy, will be treated. The clinical effects will be evaulated in terms of safety (side effects) and anti-leukemia effect.

Eligibility criteria: Inclusion Criteria:

Patients with acute leukemia, which are refractory to standard treatment. Patients should be 17 years of age or older. The performance status of the patients should be 70 or over by Karnofsky scale. Patients should not have excessive hepatic dysfunction (bilirubin less than 3.0 mg/dl, AST less than 5 times the upper normal limit).

Patients should not have excessive renal dysfunction (creatinine less than 3.0 mg/dl).

Patients should not have clinically-evident cardiac or pulmonary dysfunction. Patients and donors must sign informed consent.

Exclusion Criteria:

Patients who are pregnant or lactating are not eligible.

Primary outcomes:
measure: occurrence and severity of side effects of donor natural killer cell infusion
timeFrame: 1 year
Secondary outcomes:
measure: anti-leukemia effect of donor natural killer cell infusion
timeFrame: 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
citation: Lee KH, Lee JH, Lee JH, Kim DY, Seol M, Lee YS, Kang YA, Jeon M, Hwang HJ, Jung AR, Kim SH, Yun SC, Shin HJ. Reduced-intensity conditioning therapy with busulfan, fludarabine, and antithymocyte globulin for HLA-haploidentical hematopoietic cell transplantation in acute leukemia and myelodysplastic syndrome. Blood. 2011 Sep 1;118(9):2609-17. doi: 10.1182/blood-2011-02-339838. Epub 2011 Jun 28.
citation: Yoon SR, Lee YS, Yang SH, Ahn KH, Lee JH, Lee JH, Kim DY, Kang YA, Jeon M, Seol M, Ryu SG, Chung JW, Choi I, Lee KH. Generation of donor natural killer cells from CD34(+) progenitor cells and subsequent infusion after HLA-mismatched allogeneic hematopoietic cell transplantation: a feasibility study. Bone Marrow Transplant. 2010 Jun;45(6):1038-46. doi: 10.1038/bmt.2009.304. Epub 2009 Nov 2.
Clinical trial NCT05920278: Accuracy of Pulse Oximeters in Profound Hypoxia
Official title: Performance of the Movano Health Ring in a Controlled Hypoxia Study: Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxia
Lead sponsor: Movano Health
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2023-06-27
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult participants 18 to 49 years old, of which 2 or 15% of the subject pool is darkly pigmented.

Brief summary: The goal of this study was to evaluate the accuracy of pulse oximeters over the range of 70-100%. Two devices were placed on each subject with one on the finger and the other on the fingertip. SpO2 measurements from these devices were compared to sampling of arterial blood during brief stable oxygen desaturation in healthy volunteers to evaluate the claimed range.


Eligibility criteria: Inclusion Criteria:

* Subject is in good general health with no evidence of any medical problems.
* Subject is fluent in both written and spoken English.
* Subject provided written informed consent and is willing to comply with the study procedures.
* Subject is willing to have their skin color assessed.

Exclusion Criteria:

* Subject is obese with a BMI over 30.
* Subject has a known history of heart disease, lung disease, kidney or liver disease.
* Subject has asthma, sleep apnea, or uses a CPAP.
* Subject has diabetes.
* Subject has a clotting disorder, anemia, or in the opinion of the investigator, they would be unsuitable for participation.
* Subject has any other serious system illness.
* Subject is a current smoker.
* Subject has any injury, deformity, or abnormality at the sensor sites that, in the opinion of the investigator, would interfere with the sensors working correctly.
* Subject has a history of fainting or vasovagal response.
* Subject has a sensitivity to local anesthesia.
* Subject has Raynaud's disease.
* Subject has unacceptable collateral circulation based on an exam by the investigator.
* Subject is pregnant, lactating, or trying to get pregnant.
* Subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study procedures.
* Subject has any other condition, which in the opinion of the investigator, would make them unsuitable for the study.

Primary outcomes:
measure: RMSE compared to arterial blood SaO2
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Hypoxia Research Laboratory
state: California
Study officials:
affiliation: University of California at San Francisco (UCSF)
name: Phillip E Bickler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04477278: Examining the Impact of Mindfulness on Patients' Experience of Osteopathic Manipulation
Official title: Examining the Impact of Mindfulness on Patients' Experience of Osteopathic Manipulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Satisfaction, Patient
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single site, two-arm, parallel group pilot randomized controlled trial examining the effect of coupling a brief mindfulness-based intervention with an osteopathic manipulation session for pain patients.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for OMT at the Huntsman Cancer Institute

Exclusion Criteria:

* Altered mental status due to delirium, psychosis, or medication sedation as determined by treating clinician.

Primary outcomes:
measure: Change in Pain Intensity from immediately before session to immediately after
timeFrame: Immediately before and after the osteopathic manipulation session (i.e., 1 hour)
Secondary outcomes:
measure: Change in Sensation Ratio (Pleasant/Unpleasant) from immediately before session to immediately after
timeFrame: Immediately before and after the osteopathic manipulation session (i.e., 1 hour)
measure: Patient Satisfaction
timeFrame: Immediately after the osteopathic manipulation session
measure: Change in Mindfulness of the Body from immediately before pre-session audio recording to immediately after
timeFrame: Immediately before and after the pre-session audio recording (i.e., 10 minutes)
measure: Change in Embodied Safety from immediately before pre-session audio recording to immediately after
timeFrame: Immediately before and after the pre-session audio recording (i.e., 10 minutes)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT03981978: Validity of Physical Activity Questionnaires in Persons Pursuing Bariatric Surgery
Official title: Validity of Physical Activity Questionnaires in Persons Pursuing Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery Candidate
Obesity
Keywords: physical activity
accelerometer
bariatric surgery
obesity
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2019-06-11
Enrollment: 35
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seeking bariatric surgery at University of Nebraska Medical Center/Nebraska Medicine

Brief summary: The purpose of this study is to determine the validity of the Human Activity Profile and Godin self-report questionnaires of physical activity in persons seeking metabolic surgery.

Detailed description: This cross-sectional study will collect subject's medical history, anthropometric measurements, physical activity data through an accelerometer worn on the wrist and indirect physical activity measures via the Human Activity Profile and Godin self-report questionnaires. We will collect clinical information from the medical record including predictors of physical activity level in obesity such as nutritional lab and co-morbid conditions.

Eligibility criteria: Inclusion Criteria:

* Age \>19
* BMI \> 30
* Able to speak and understand English
* Consent to provide access to medical records for medical history
* Will receive weight loss procedure (sleeve gastrectomy or gastric bypass) at Nebraska Medicine
* Consent to wear an activity tracker device for 7 days after designated visits.

Exclusion Criteria:

• Age \< 19

Primary outcomes:
measure: Human Activity Profile Questionnaire
timeFrame: Baseline - Single time point
Secondary outcomes:
measure: Godin-Shephard Leisure Time Physical Activity (Godin) questionnaire
timeFrame: Baseline - Single time point
measure: Accelerometer
timeFrame: Baseline - Single time point
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center, Bariatric Center
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center, Physical Activity Lab
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Laura D Bilek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06832878: Postoperative Oral Tranexamic Acid in Patients Undergoing Primary Total Joint Arthroplasty
Official title: Postoperative Oral Tranexamic Acid in Patients Undergoing Primary Total Joint Arthroplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Arthroplasty
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the impact of an extended oral Tranexamic Acid regimen on patient reported outcome scores, time to independent ambulation, postoperative range of motion, swelling, change in hemoglobin levels, 90-day complications, readmission and reoperation.


Eligibility criteria: Inclusion Criteria

* Adults aged \> 18 years (All women of childbearing potential undergo pregnancy testing prior to THA as per our institutional protocol)
* Written informed consent
* Patients undergoing primary THA diagnosis of end-stage osteoarthritis
* Patients receiving spinal anesthesia
* Patients being discharged on postoperative day 1

Exclusion Criteria

* Patients with a TXA allergy
* Patients undergoing revision procedures
* Patients undergoing primary THA for a diagnosis other than end-stage osteoarthritis
* Patients receiving general anesthesia
* Patients being discharged on the same day of surgery
* Cancer patients
* Patients with a history of prior VTE event
* Patients on preoperative anticoagulants other than ASA
* Pregnant patients (All women of child bearing potential undergo pregnancy testing prior to THA as per our institutional protocol)
* Female patients who are on hormonal contraception
* Patients with history of retinal vein or artery occlusion

Primary outcomes:
measure: Visual Analog Score
timeFrame: Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks
measure: Hip Disability and Osteoarthritis Outcome Score (HOOS) for Joint Replacement (JR)
timeFrame: Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks
Secondary outcomes:
measure: Hemoglobin
timeFrame: Baseline, prior to discharge, day 3 postoperatively
measure: Harris Hip Score (HHS)
timeFrame: Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks
measure: Short Form Health Survey (SF-12)
timeFrame: Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks
measure: Time to Independent Ambulation
timeFrame: 12 weeks
measure: Oxford Hip Score
timeFrame: Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Joshua Bingham
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03928678: Implementation of Enhanced Recovery After Surgery Program (ERAS) in Colorectal Cancer Surgery, a Randomized Controlled Trial
Official title: Enhanced Recovery After Surgery Program (ERAS) in Colorectal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Colon
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of our study is to determine the effect of implementation of the ERAS (enhanced recovery after surgery) protocol in our institute and its impact on hospital length of stay and outcome of surgery.


Eligibility criteria: Inclusion Criteria:

* Age ≤ 60 years,
* Good nutrition,
* No systemic infection and
* Elective laparoscopic surgery

Exclusion Criteria:

* Age \>75 years,
* Malnutrition or an organ system infection
* Associated with obstruction, bleeding, emergency surgery or other surgical intervention
* Tumor with extensive metastasis
* Prior to surgery, patient was fasting, underwent gastrointestinal decompression and received nutritional support
* Previous history of abdominal surgery
* Patient have previously undergone gastrostomy

Primary outcomes:
measure: length of hospital stay in days
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: South Egypt Cancer Instuite
Study officials:
References:
Clinical trial NCT00581178: Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation
Official title: Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Kidney Stones
Keywords: Ureteral Stent
Kidney Stones
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Labcorp Corporation of America Holdings, Inc
First posted: 2007-12-27
Enrollment: 16
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: All patients who will undergo surgery where a ureteral stent will likely be placed will be offered enrollment into this study.

Brief summary: Ureteral stent placement is one of the most common procedures performed within urology. The stents are generally placed for relief of obstruction or to prevent obstruction following a urological procedure. Most patients with ureteral stents will eventually form stent encrustations. However, patients form these encrustations at dramatically different degrees and rates ranging from no encrustation at 1 year of stenting to severe encrustation in just a few weeks. The purpose of this study is to determine if the degree of encrustation on a stent for any given patient can be predicted based on 24 hour urine parameters prior to stent placement, with the stent in place and after stent removal.

Patients who will be receiving stents for other urological reasons will have a 24 hour urine sample collected before stent placement, while the stent is in place and after the stent has been removed. The parameters examined in the 24 hour urine collected will then be compared to the amount of encrustation there is on the stent to see if there is any correlation between the two.


Eligibility criteria: Inclusion Criteria:

* Patient at UCI
* Scheduled to undergo surgery (standard of care) where ureteral stent will be placed

Exclusion Criteria:

* minors

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Ralph Clayman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01647178: TORQ Clinical Study
Official title: The Influence of the TORQ Sternal Closure Assistance Device on Post-Operative Pain, Pulmonary Function and Quality of Life Compared to Traditional Manual Wire Closure: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Cardiac Surgery
Sternal Closure
Lead sponsor: Kardium Inc.
Sponsor class: INDUSTRY
Collaborators: name: St. Paul's Hospital, Canada
First posted: 2012-07-23
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed trial is to evaluate the use of the TORQ closure assistance device and how it affects pain in the sternum, breathing and quality of life compared to traditional use of needle drivers or similar to close sternal wires.


Eligibility criteria: Inclusion Criteria:

* Referred for elective cardiac surgery at St Paul's Hospital
* Expected to live greater than 12 months
* Capable of giving written informed consent
* Willing to participate in follow-up
* Greater than 18 years of age, and of legal age of consent in host country

Exclusion Criteria:

* Patient has had previous median sternotomy, requiring redo sternotomy
* Surgeon has, prior to enrollment, elected to use alternative closure technique to the interrupted single wire circlage technique (e.g. Figure of 8 technique)
* Surgeon has elected, prior to enrollment. to treat with the TORQ as a prophylactic measure (e.g. in high risk cases where use of the TORQ has been shown to be effective in preventing dehiscence)

Primary outcomes:
measure: Respiratory function
timeFrame: Pre-op, 2 and 4 days Post-op
measure: Pain Score
timeFrame: 2, 4, 14, 30 and 90 days post op
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: St. Paul's Hospital, Canada
name: James Abel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04198337: Endoscopic Full Thickness Resection for Gastric GIST
Official title: Prospective Clinical Study on Safety and Effectiveness of Endoscopic Full Thickness Resection for Treatment of Patients With Gastric Gastrointestinal Stromal Tumors (GIST)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric GIST
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a clinical trial to evaluate the efficacy and safety of endoscopic full thickness resection for treatment of gastric GIST

Detailed description: To evaluate the clinical safety and efficacy of endoscopic full thickness resection (EFTR) for treatment of gastric GIST. A total of 30 patients will be recruited

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 and ≤ 80
2. Gastric submucosal tumors located at cardia, lesser curvature and antrum
3. Size of the submucosal tumor between 10mm to 30mm as assessed by endoscopic

Exclusion Criteria:

1. Patients who are considered as unfit for general anesthesia
2. ASA class ≥ IV or moribund patients
3. Pregnancy
4. Gastric submucosal tumors located at greater curvature and fundus

Primary outcomes:
measure: Complete resection of GIST
timeFrame: 30 days
Secondary outcomes:
measure: Adverse event rate
timeFrame: 30 days
measure: Perioperative mortality
timeFrame: 30 days
measure: Histolology assessment
timeFrame: 30 days
measure: Hospital stay
timeFrame: 30 days
measure: technical success in complete resection
timeFrame: 1 day
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong
state: Outside Of US & Canada
Study officials:
affiliation: Chinese University of Hong Kong
name: Philip Wai Yan Chiu, MD, FRCSEd
role: PRINCIPAL_INVESTIGATOR
References: