louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01193010: Computer Assisted Planing of Corrective Osteotomy for Distal Radius Malunion
Official title: Computer-Assisted Versus Non-Computer Assisted Preoperative Planning of Corrective Osteotomy for Extra-Articular Distal Radius Malunions: A Multi-Center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extraarticular Distal Radius Malunion
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: AO foundation
First posted: 2010-09-01
Enrollment: 40
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: This study is designed as a multi-center randomized controlled trial, comparing two groups of patients with symptomatic extra-articular malunited distal radius fractures. One group of patients will undergo corrective surgery of the distal radius, with preoperative computer-assisted planning and virtual osteotomy, and the other group will undergo corrective surgery, with conventional (non-computer-assisted) preoperative planning. The investigators hypothesize that computer-assisted surgical planning will result in a better functional outcome.


Eligibility criteria: Inclusion Criteria:

* Extraarticular distal radius malunion requiring surgery
* Adult patient (\> 18 yo)
* Fluent in English

Exclusion Criteria:

* Pregnant patient
* Prisoner
* Abnormal contralateral forearm

Primary outcomes:
measure: Disability of the Shoulder and Hand Score
timeFrame: 0, 3, 6, 12 months
Secondary outcomes:
measure: Patient-Rated Wrist Evaluation (PWRE_
timeFrame: 0, 3, 6, 12 months
measure: Numerical Rating Scale for Pain
timeFrame: 0, 3, 6, 12 months
measure: Numerical Rating Scale for Satisfaction
timeFrame: 0, 3, 6, 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: MGH
name: Jupiter Jesse, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leong NL, Buijze GA, Fu EC, Stockmans F, Jupiter JB; Distal Radius Malunion (DiRaM) collaborative group. Computer-assisted versus non-computer-assisted preoperative planning of corrective osteotomy for extra-articular distal radius malunions: a randomized controlled trial. BMC Musculoskelet Disord. 2010 Dec 14;11:282. doi: 10.1186/1471-2474-11-282.
Clinical trial NCT03689010: To Evaluate the Therapeutic Equivalence and Safety in Treatment of Moderate Facial Rosacea
Official title: A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Taro Product to RLD, and Both Active Treatments to a Placebo Control in the Treatment of Moderate Facial Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rosacea
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2018-09-28
Enrollment: 1116
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: To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of moderate facial rosacea.

Detailed description: A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study, comparing test and reference products and both active treatments to a placebo control in the treatment of Moderate Facial Rosacea.

Eligibility criteria: Inclusion Criteria:

* Healthy male or non-pregnant female aged ≥ 18 with a clinical diagnosis of facial rosacea.
* Subjects must have provided IRB approved written informed consent.

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
* Subjects who have used estrogens or oral contraceptives for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study.

Primary outcomes:
measure: change in the inflammatory lesion counts
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Catawba Research, LLC
state: North Carolina
Study officials:
affiliation: Taro Pharmaceuticals
name: Natalie Yantovskiy
role: STUDY_DIRECTOR
References:
Clinical trial NCT06640010: Using Induced-Pluripotent Stem Cells to Model Cancer Therapy-Related Adverse Events
Official title: Using Induced-Pluripotent Stem Cells to Model Cancer Therapy-Related Adverse Events
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult cancer patients who have already started or are planning to start cancer treatment

Brief summary: This study is being done to find out if patient blood samples can be used to perform individualized modeling of cancer therapy-related side effects.

Detailed description: PRIMARY OBJECTIVES:

I. Generate induced pluripotent stem cells (iPSC's) from patients receiving cancer treatment.

II. Differentiate patient iPSC's into cardiomyocytes and/or neurons or other cell types that may be relevant to modeling cancer therapy-related adverse effects, such as cardiotoxicity and neurotoxicity.

III. Use patient specific iPSC-derived cells to:

IIIa. Model cancer therapy-related toxicities; IIIb. Better understand the mechanisms of toxicities; IIIc. Determine if patient specific genetic variants are causative of toxicities; IIId. Screen novel protective therapies for cancer therapy-related toxicities.

OUTLINE: This is an observational study.

Patients undergo blood sample collection and have their medical records reviewed on study.

Eligibility criteria: Inclusion Criteria:

* \* Any patient \>= 18 years of age

  * Planned or receiving any potentially toxic cancer therapy including but not limited to chemotherapy, targeted and immunotherapies

Exclusion Criteria:

* Inability on the part of the patient to understand the informed consent or be compliant with the protocol

Primary outcomes:
measure: In vitro measurement of cellular viability in response to chemotherapy
timeFrame: Blood drawn at enrollment to obtain sample
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Nadine Norton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02187510: Umbilical Cord Milking vs Delayed Cord Clamping in Preterm Infants Born by Cesarean Section
Official title: Umbilical Cord Milking Compared With Delayed Cord Clamping to Increase Plancental Transfusion in Preterm Infants Less Than 34 Weeks' Gestation Born by Cesarean Section. Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Infant
Umbilical Cord
Milking
Delayed Clamping
Keywords: Hemodynamics
Premature Infant
Umbilical cord
Milking
Delayed clamping
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2014-07-11
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the umbilical cord milking in preterm infants born by cesarian section less than 34 weeks is more effective than delayed cord clamping to obtain higher levels of hemoglobin.


Eligibility criteria: Inclusion Criteria:

* Preterm infants less than 34 weeks' gestation born by cesarean section

Exclusion Criteria:

* Inability to obtain informed consent from the mother state
* Monochorionic-monoamniotic twin gestation
* Placenta abruption
* Uterine rupture
* Transplacental cesarean
* Hydrops fetalis

Primary outcomes:
measure: Haemoglobin
timeFrame: 1 hour and 24 hours at born
Secondary outcomes:
measure: Apgar Score
timeFrame: 1 and 5 minutes
measure: Arterial pressure
timeFrame: 2, 6, 12, 24, 36 and 48 hours of life
measure: Orine volume
timeFrame: 24 and 48 hours of life
measure: Use of vasopresors drugs
timeFrame: 24 hours of life
measure: Number of concentrate hematies transfusion
timeFrame: participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
measure: Intraventricular hemorrhage
timeFrame: participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
measure: Bronchopulmonary dysplasia
timeFrame: participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
measure: Total intensive care unit stay
timeFrame: Participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
measure: Hematocrit
timeFrame: 1 hour and 24 hours at born
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
state: Barcelona
Study officials:
affiliation: Corporacio Sanitaria Parc Tauli
name: Monica Domingo-Puiggros, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03530410: Gastric and Autonomic Functions in Patients With Intragastric Balloon
Official title: Gastric and Autonomic Functions in Patients With Intragastric Balloon
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Obesity
Obesity, Morbid
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo intragastric balloon implantation

Brief summary: The study aims to measure the effect of intragastric balloon on gastric function, particularly gastric accommodation and pace making, and the possible underlying changes in autonomic function

Detailed description: The intragastric balloon is a space-occupying device that is hypothesized to function by inducing early satiety. Additionally, insertion of an intragastric balloon causes delayed gastric emptying; longer gastric emptying times after balloon insertion are correlated with more weight loss. The exact mechanism of function, however, is not clear and likely multifactorial. The investigators hypothesize that the intragastric balloon causes weight loss by affecting gastric and autonomic function, including pace-making and accommodation, and that the difference in responsiveness among patients may be mediated by differences in gastric function.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo intragastric balloon implantation
* Ability to comply to study schedule.

Exclusion Criteria:

* Unable to give informed consent
* Currently taking prokinetic, anticholinergic or dopaminergic agents which could potentially modify gastric motility
* Have a history of bariatric or gastrointestinal surgery
* Pregnant or preparing to conceive a child.

Primary outcomes:
measure: Gastric slow waves
timeFrame: 1 year
measure: Gastric accommodation
timeFrame: 1 year
measure: Autonomic function
timeFrame: 1 year
Secondary outcomes:
measure: Gastroparesis cardinal symptom index (GCSI) questionnaire
timeFrame: 1 year
measure: Gastroesophageal reflux disease-health related quality of life (GERD-HRQL) questionnaire
timeFrame: 1 year
measure: Dyspepsia symptom severity index (DSSI) questionnaire
timeFrame: 1 year
measure: SF-36 Questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Vivek Kumbhari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03990610: An Investigational Surgical Procedure (Vascularized Lymph Node Transfer) in Reducing the Risk of Lymphedema in Patients With Breast Cancer Undergoing Breast Reconstruction
Official title: Assessment of Outcomes Following Prophylactic Lymph Node Transfer in Patients Undergoing Autologous Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-06-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial studies how an investigational surgical procedure called vascularized lymph node transfer works in lowering the risk of arm swelling (lymphedema) in patients with breast cancer undergoing breast reconstruction. Patients who undergo breast reconstruction are often at high risk of developing lymphedema. Vascularized lymph node transfer involves transferring lymph nodes from an unaffected area of the body to replace those removed as part of treatment, which may lower the risk of lymphedema after breast reconstruction.

Detailed description: PRIMARY OBJECTIVE:

I. Determine incidence of patients who develop lymphedema following autologous breast reconstruction.

SECONDARY OBJECTIVES:

I. Determine the overall complications of prophylactic vascularized lymph node transfers.

II. Compare the incidence of patients who develop lymphedema following autologous breast reconstruction among patients who had prophylactic lymph node transfer and a historical cohort who did not have prophylactic lymph node transfer.

OUTLINE:

Patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery.

After completion of study, patients are followed up for 3 weeks, at 3 and 6 months, and then at 1 and 2 years.

Eligibility criteria: Inclusion Criteria:

* Patients who have undergone treatment (mastectomy, axillary lymph node dissection \[ALND\], radiation and chemotherapy) for breast cancer and are seeking breast reconstruction

Exclusion Criteria:

* Patients that are known to be pregnant at the time of surgery
* Patients with a known hypersensitivity to indocyanine green (ICG) and/or isosulfan blue (Lymphazurin)

Primary outcomes:
measure: Incidence rate of lymphedema development
timeFrame: At 12 months after surgery
measure: Time to lymphedema development
timeFrame: Up to 2 years
Secondary outcomes:
measure: Incidence rate of lymphedema development
timeFrame: Up to 2 years
measure: Complications of prophylactic VLNT
timeFrame: Within 30 days after surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Edward I Chang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02030210: CP4ACS - Delphi Study to Determine Appropriateness of STEMI Quality Indicators in Belgium
Official title: Quality of Care for STEMI - Patients. a Research to Determine Appropriateness of STEMI Quality Indicators in Belgium, a RAND/UCLA Modified Delphi Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: STEMI
Quality Indicators
Keywords: Quality improvement
STEMI
Belgium
Lead sponsor: European Pathway Association
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
name: KU Leuven
First posted: 2014-01-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We aim to engage 20 cardiologists and 20 cardio nurses, all experienced in the care for STEMI patients

Brief summary: RAND/UCLA modified Delphi study on quality indicators for STEMI to determine the appropriateness of quality indicators retrieved from literature and guideline review. We aim to engage 20 cardiologists and 20 nurses with relevant experience in the care for STEMI patients.


Eligibility criteria: Inclusion Criteria:

* cardiologist or cardio nurse with relevant experience in the care for STEMI patients

Exclusion Criteria:

-

Primary outcomes:
measure: validated quality indicators for STEMI care in belgium (both on patient and on hospital level)
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
state: Vlaams Brabant
Study officials:
affiliation: KU Leuven
name: Kris Vanhaecht, dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03973710: Effect of Probiotics on Blood Pressure Management
Official title: Role of Probiotics in the Prevention of Hypertension
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Hypertension
Keywords: Probiotics
Prevention
Hypertension
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Dysbiosis of gut microbiota has been reported to be involved in the development and progression of hypertension in both humans and animal models. Probiotics have been reported to have ameliorative effects in murine models. However, whether probiotics could help alleviate hypertension in adults remain obscure.

Detailed description: Probiotics are live microorganisms that have been associated with multiple health benefits. However, its protective role in adults has long been controversial. This study aims to examine the effect of 12-week probiotics supplementation on the prevention of hypertension in Chinese adults. By understanding the mechanisms by which probiotics exert this beneficial effects, we can better control the rising prevalence of hypertension, which is a major risk factor for cardiovascular diseases.

Eligibility criteria: Inclusion Criteria:

* Eligible subjects include men and women 18 to 75 years of age with pre-hypertension who has a systemic blood between 120 and 139 mmHg and/ or a diastolic blood pressure between 80 and 80 mmHg;
* Absence of any diet, dietary supplement and medications that might interfere with blood pressure and gut microbiota, especially antibiotics and probiotics.

Exclusion Criteria:

* Any other systemic, metabolic and cardiovascular or cerebrovascular diseases;
* Type 1 diabetes, type 2 diabetes treated with insulin or other medications;
* Acute illness or current evidence of acute or chronic inflammatory or infective diseases;
* Participation in any diet or lifestyle program more than 2 times per week in the latest 3 months prior to recruitment;
* Mental illness rendering them unable to understand the nature, scope, and possible consequences of the study.

Primary outcomes:
measure: changes of systolic blood pressure
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: changes of diastolic blood pressure
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: changes of gut microbiota
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
Secondary outcomes:
measure: changes of pulse wave velocity
timeFrame: baseline and after 12-week intervention
measure: changes of ankle brachial index
timeFrame: baseline and after 12-week intervention
measure: changes of microbial metabolite
timeFrame: baseline and after 12-week intervention
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Nutrition and Food Hygiene
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Min Xia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05640310: Prospective Study to Validate the Clinical Accuracy of Norbert Device to Measure Body Temperature
Official title: Prospective Study to Validate the Clinical Accuracy of Norbert Device to Measure Body Temperature
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Healthy
Febrile Illness
Keywords: medical device
validation
febrile
thermometer
body temperature
Norbert Device
Norbert Health
Lead sponsor: Norbert Health
Sponsor class: INDUSTRY
Collaborators: name: Northwell Health
First posted: 2022-12-07
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted within an Emergency Department where each subject is assigned an Emergency Severity Index (ESI) score. Only subjects with ESI scores ranging from 3-5 will be recruited for the study to prevent intervening with standard patient care.

Brief summary: The study will evaluate the clinical bias and clinical repeatability of measuring body temperature using the Norbert Device (ND).

Detailed description: The study design is based on the ISO 80601-2-56, Clause 201.102 for adjusted mode clinical thermometers. The study is designed to be a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the ND's temperature measurement compared to a standard FDA 510(k)-cleared reference clinical thermometer (RCT).

Eligibility criteria: Inclusion Criteria:

* Male or female subjects over 22 years of age
* Ability to provide signed informed consent, and/or have a legally authorized representative (LAR) willing to provide informed consent on behalf of the subject
* ESI score of 3-5

Exclusion Criteria:

* Use of medications known to affect body temperature (for example, antipyretics, barbiturates, thyroid preparations, antipsychotics, etc.) within 3 hours of the study procedure
* Recent immunization within seven days of the study procedure
* Pregnancy
* ESI score of 1-2

Primary outcomes:
measure: Clinical Bias
timeFrame: Up to 1 hour
measure: Limits of Agreement
timeFrame: Up to 1 hour
measure: Clinical Repeatability
timeFrame: Up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: