louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01976455: The Breathe Light Study
Official title: The Breathe Light Study: Validation of Carbon Stable Isotope Ratio in Breath as an Indicator of Energy Balance and Substrate Utilization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Over-eating
Obesity
Keywords: obesity
carbon13
over-eating
metabolic chamber
room calorimeter
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2013-11-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Men \& Women age 18 to 65 years with a BMI of 25- 40 kg/m2.

Brief summary: The purpose of this study is to develop a novel, non-invasive method that will provide personalized feedback during dietary interventions as a marker for compliance.


Eligibility criteria: Inclusion Criteria:

* 18 to 65 years old
* Overweight (BMI 25-40 kg/m2)

Exclusion Criteria:

* Metabolic or cardiovascular abnormalities (diabetes, uncontrolled hypertension, etc.)
* Gastrointestinal disorders
* Disease that affects macronutrient utilization
* Medication that affects macronutrient utilization
* Allergies to foods to be utilized in the study (including but not limited to lactose intolerance/milk allergy)
* Use of nutritional/sport supplements
* Pregnant or currently trying to become pregnant

Primary outcomes:
measure: Increase in breath Carbon 13 with overconsumption of calories
timeFrame: 11 days
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: Shanon Casperson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: USDA Grand Forks Human Nutrition Research Center
name: James N Roemmich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02301455: REACH OUT: to Reduce High Blood Pressure in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Stroke
Keywords: hypertension treatment
stroke prevention
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-11-26
Enrollment: 104
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: One of the most powerful predictors of stroke is hypertension, with estimates of approximately 33% of adults in the United States experiencing this condition.

Hypertension is very prevalent in the emergency department (ED), but significantly undertreated. The overall goal of this project is to develop a text messaging intervention to improve hypertension care in the ED. This will first be done by testing the feasibility of identifying hypertensive patients in the ED, and the response rate to text messages.


Eligibility criteria: Inclusion Criteria:

* Adult (≥18 y/o)
* At least one BP of systolic blood pressure (SBP) ≥160 or a diastolic blood pressure (DBP) ≥100 or only BP performed prior to enrollment is SBP ≥160 or a DBP ≥100 (If the patient has repeated measurements after achieving Criteria 1, but prior to being enrolled, at least one of the repeat BP remains SBP ≥140 or a DBP ≥90)
* Must have mobile phones with text-messaging capability
* Likely to be discharged from the ED

Exclusion Criteria:

* Adult who is in an urgent condition
* Unable to read
* Non-English speaking
* Incarcerated/ institutionalized resident
* Pregnant, or has a pre-existing condition that makes follow-up for 4 months unlikely.

Primary outcomes:
measure: Proportion of people who respond to text messages and are persistently hypertensive
timeFrame: 3 weeks
Secondary outcomes:
measure: Change in systolic and diastolic blood pressure
timeFrame: 4 months
measure: Feasibility of a screening algorithm
timeFrame: 4 months
measure: Feasibility of subject follow-up mechanism
timeFrame: 4 months
measure: Mean group differences and standard deviations for systolic blood pressure
timeFrame: 4 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
state: Michigan
Study officials:
References:
citation: Meurer WJ, Dome M, Brown D, Delemos D, Oska S, Gorom V, Skolarus L. Feasibility of Emergency Department-initiated, Mobile Health Blood Pressure Intervention: An Exploratory, Randomized Clinical Trial. Acad Emerg Med. 2019 May;26(5):517-527. doi: 10.1111/acem.13691. Epub 2019 Feb 19.
Clinical trial NCT05447455: TAP Block vs LAWI for Analgesia Post-cesarean Section
Official title: the Efficacy of Transversus Abdominis Plane Block for Analgesia in Comparison With Local Anesthetic Wound Infiltration Post-cesarean Section: A Randomized Comparative Double-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstetric Pain
Obstetric Anesthesia Problems
Keywords: transversus abdominis plane. VAS; visual analogue score; wound infiltration; cesarean section; postoperative pain; analgesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 200
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Adequate pain control after cesarean delivery is a significant concern both for parturients and obstetric anesthesiologists. Transversus Abdominis Plane (TAP) block and local Wound infiltration with anesthetics are alternatives for reducing the severity of pain, total analgesic consumption, and opioid side effects. Both the TAP block and wound infiltration are superior to placebo; however, it is unknown which provides better analgesia after cesarean delivery because of a scarcity of randomized clinical trials. So, we hypothesized that the TAP block would decrease postoperative pain and postoperative cumulative opioid consumption at 24 hours


Eligibility criteria: Inclusion Criteria:

1. Women who underwent cesarean section under spinal anesthesia.
2. Aged ≥19 years and less than 40 years.
3. Gestational age ≥ 37 Weeks.

Exclusion Criteria:

1. Body mass index (BMI) ≥40 kg/m2.
2. History of recent opioid exposure
3. Hypersensitivity to any of the drugs used in the study.
4. Significant cardiovascular, renal, or hepatic disease

Primary outcomes:
measure: degree of pain at rest and on movement (hip flexion and coughing) at 2, 4, 6, 12, and 24 hours postoperatively
timeFrame: 24 hours
Secondary outcomes:
measure: measures the time to the first postoperative opioid dose
timeFrame: 24 hours
measure: cumulative opioid consumption at 2, 4, 6, and 12 hours.
timeFrame: 12 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of medicine - Cairo university
state: Kasr El Ainy
Study officials:
affiliation: Cairo University
name: Mohammed A Taymour, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03020355: Comparison of Blood Loss in Using vs Not Using Placental Cord Drainage After Spontaneous Vaginal Delivery
Official title: Comparison of Blood Loss in Using vs Not Using Placental Cord Drainage After Spontaneous Vaginal Delivery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Placental Blood Drainage
Lead sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 200
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of effectiveness of placental blood drainage after spontaneous vaginal delivery in decreasing the duration, blood loss,and complications of the third stage, against no drainage of placental blood.

Detailed description: The patients will prospectively randomized equally into two groups (100 each in the study and control groups).

Group-A (Study group)-Placental blood was drained.

Group-B (Control group)-Placental blood was not drained.

In all the patients detailed medical and obstetric history will taken. In each patient, the pre-delivery pulse rate, blood pressure, and Hb gm% will noted. Immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased. In the control group, the clamped cord will not released. Blood lost in the third stage of labour will measured by collecting the blood measuring bag.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* Vertex presentation
* Gestational age of 37 weeks (or) more
* No major medical (or) obstetric complications
* Spontaneous vaginal delivery

Exclusion Criteria:

* Hb\\7 gm/dl
* History of APH
* Instrumental delivery
* Multiple pregnancy
* Malpresentations
* Large baby (more than 3.5 kg)
* Polyhydramnios
* Known coagulations disorders
* Previous surgeries on the uterus

Primary outcomes:
measure: Blood lost
timeFrame: through delivery completion, an average of 30 minutes
Secondary outcomes:
measure: The duration of the third stage
timeFrame: through the duration of the third stage, an average 45 minutes
Other outcomes:
Locations:
Study officials:
References:
citation: Roy P, Sujatha MS, Bhandiwad A, Biswas B, Chatterjee A. Placental Blood Drainage as a Part of Active Management of Third Stage of Labour After Spontaneous Vaginal Delivery. J Obstet Gynaecol India. 2016 Oct;66(Suppl 1):242-5. doi: 10.1007/s13224-016-0857-3. Epub 2016 Mar 12.
citation: Soltani H, Poulose TA, Hutchon DR. Placental cord drainage after vaginal delivery as part of the management of the third stage of labour. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD004665. doi: 10.1002/14651858.CD004665.pub3.
Clinical trial NCT05416255: Measuring Synovial Fluid Components
Official title: Measuring Synovial Fluid Components
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Dharma Bioscience
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Consecutive patients treated for knee osteoathritis with dextrose injection, hemaopoietic stem cell injection, PRP injection, or no injection.
Primary purpose: TREATMENT

Brief summary: Participants with grade 3 and 4 knee osteoarthritis will recieve aspiration of synoivial fluid, and then receive either dextrose, hemaotopoietic stem cell, or platelet rich plasma, or no injection. The synovial fluid will be analyzed for changes in components.

Detailed description: 80 participants with grade 3 and 4 symptomatic knee osteoarthritis, with a visable effusion, will receive aspiration of 3 ml of synovial fluid from the suprapatellar pouch, followed by either injection with 10 mL of 12.5% dextrose, 10 cc hematopoietic stem cells, 10cc PRP, or no injection into the suprapatellar pouch. They will then receive aspiration of 3 ml of synovial fluid at 2 days and either 7 days (for dextrose injected or no injection) or 14 days (stem cell and PRP injected) days post injection. These synovial samples will be analyzed for a change in components.

Eligibility criteria: Inclusion Criteria:≥ 6 months of knee pain with walking

* ≥ 6/10 on a 0-10 point numerical rating scale
* High grade medial compartment cartilage loss ( Kellgren-Lawrence grade 3 or 4) on plain weight bearing X-ray
* Exposed subchondral bone at 110 degrees of flexion by ultrasound examination
* Easily visible suprapatellar pouch with quads conttraction.

Exclusion Criteria

* Current intake of NSAIDs or steroids
* Current anticoagulation therapy
* Inflammatory or post-infectious knee arthritis
* Systemic inflammatory conditions
* Knee flexion less than 100 degrees
* Knee extension less than 165 degrees
* Valgus or varus more than 15 degrees
* Any knee injection in the precedign 3 months
* BMI more than 50 kg/ meter squared
* Gross synovial folds on ultrasound.

Primary outcomes:
measure: Cytokine and unspecified component levels in synovial fluid
timeFrame: Day 0 to Day 14
Secondary outcomes:
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC) (0-100 scale) Higher scores are a worse outcome.
timeFrame: Day 0 to Day 14
Other outcomes:
measure: 0-10 Numerical Rating Scale for pain (NRS) (11 point scale. Higher values are a worse outcome)
timeFrame: Day to Day 14
Locations:
city: Rosario
country: Argentina
facility: Dharma Centro de Medicina Regenerativa
state: Santa Fe
Study officials:
References:
Clinical trial NCT06592755: Single-Incision Gasless Endoscopic Total Thyroidectomy Via Subclavian Approach Versus Open Surgery for PTC
Official title: Single-Incision Gasless Endoscopic Total Thyroidectomy Via Subclavian Approach Versus Open Surgery for Papillary Thyroid Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Papillary Thyroid Carcinoma
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients, who were diagnosed with papillary thyroid carcinoma at our center, chose to undergo either single-incision, gasless endoscopic total thyroidectomy with central compartment neck dissection via the subclavian approach or conventional open surgery.

Brief summary: Historically, performing a contralateral thyroid lobectomy and lymph node dissection via the subclavian approach was considered challenging. This study aimed to evaluate the safety and feasibility of single-incision gasless endoscopic total thyroidectomy and central compartment neck dissection via the subclavian approach (SCA) in comparison to conventional open surgery for the treatment of papillary thyroid carcinoma (PTC) retrospectively.

Detailed description: Historically, performing a contralateral thyroid lobectomy and lymph node dissection via the subclavian approach was considered challenging. This study aimed to evaluate the safety and feasibility of single-incision gasless endoscopic total thyroidectomy and central compartment neck dissection via the subclavian approach (SCA) in comparison to conventional open surgery for the treatment of papillary thyroid carcinoma (PTC) retrospectively.

Eligibility criteria: Inclusion Criteria:

* (1) thyroid neoplasm \&lt;3.0 cm;
* (2) well differentiated papillary thyroid carcinoma.

Exclusion Criteria:

* (1) extrathyroidal extensions estimated in ultrasonography scan;
* (2) enlarged lymph nodes in lateral neck compartment on palpation, or US scan;
* (3) suspected distant metastases;
* (4) previous history of neck radiation therapy and/or surgery.

Primary outcomes:
measure: the disease-free survival
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT02202655: Study of Changes of Lymphocyte Subsets in Chemotherapy Course of Patients With Non-small Cell Lung Cancer
Official title: Study of Changes of Lymphocyte Subsets in Chemotherapy Course of Patients With Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer
Keywords: non- small cell lung cancer;
lymphocyte subsets
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2014-07-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with non-small cell lung cancer who accept chemotherapy for the first time are acceptable.

Brief summary: The purpose of this study is to investigate the changes of lymphocyte subsets in chemotherapy course of patients with non-small cell lung cancer

Detailed description: patients with primary non-small cell lung cancer who received first chemotherapy in Beijing Chaoyang Hospital affiliated to Capital Medical University were collected, and the percentage of lymphocyte subsets at 9 time points before, during, and after chemotherapy was detected by flow cytometry method.We will investigate the changes of patients' lymphocyte subsets in chemotherapy courses. The correlation of the percentage of lymphocyte subsets and age, gender, pathological type, clinical stage, surgery or not, clinical efficacy assessment will be further analyzed.

Eligibility criteria: Inclusion Criteria:

* Each Period Non-small Cell Lung Cancer, Which Was Confirmed by Histopathology. patients has only lung cancer .
* Functional Status Score (PS) ≧ 70.
* The first time for chemotherapy .
* A Written Informed Consent.

Exclusion Criteria:

* Merging other tumors.
* HAve autoimmune diseases.
* AIDS

Primary outcomes:
measure: the changes of patients' lymphocyte subsets in chemotherapy courses.
timeFrame: up to cycle 4 day 9
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: WangQian
state: Beijing
Study officials:
affiliation: Vice President of the Beijing chaoyang hospital
name: yingmin ma
role: STUDY_DIRECTOR
References:
Clinical trial NCT03744455: Influence of Resident's Degree of Formation on the Quality of Care Delivered to the Patients.
Official title: Influence of Resident's Degree of Formation on the Quality of Care Delivered to the Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia Complication
Lead sponsor: Astes
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients scheduled for hand surgery under axillary plexus in the Clinique Saint-Luc of Bouge (Namur, Belgium)

Brief summary: The aim of this study is to evaluation the influence of the resident in anesthesiology's degree of formation on the quality of care delivered to the patient.

Detailed description: The aim of this study is to evaluation the influence of the resident in anesthesiology's degree of formation on the quality of care delivered to the patient.

To perform it, the investigators will enrolled all of the patients scheduled for an axillary plexus anesthesia technique in the Clinique Saint-Luc of Bouge in September 2018 (end of formation for the residents in anesthesia) and compare the patient's degree of satisfaction with the patients scheduled for the same kind of anesthesia on October and November 2018 (begin of formation for the residents in anesthesia).

Eligibility criteria: Inclusion Criteria:

* All patients scheduled for hand surgery under axillary plexus

Exclusion Criteria:

* Patient's refusal

Primary outcomes:
measure: Patient satisfaction (Likert's scale)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Namur
country: Belgium
facility: Clinique Saint-Luc Bouge
Study officials:
affiliation: Astes
name: Eric Deflandre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00192855: Entacapone Augmentation for Schizophrenia
Official title: Entacapone Augmentation for Schizophrenia- A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
negative symptoms
entacapone
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study is testing the hypothesis that Entacapone added to ongoing antipsychotic treatment can be beneficial in schizophrenic patients with negative symptoms.


Eligibility criteria: Inclusion Criteria:

* predominantly negative symptoms
* stable on ongoing antipsychotic treatment

Exclusion Criteria:

* acute psychotic exacerbation
* suicidal ideation
* uncontrolled systemic disease

Primary outcomes:
measure: Improvement in specific rating scales during the study and after completion, compared to baseline.
timeFrame: Baseline and once a month untill end of study
Secondary outcomes:
measure: Change in PANSS score.
timeFrame: Before and after intervention
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam medical center
Study officials:
affiliation: Rambam Health Care Campus
name: Ehud Klein
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06298214: Testing the Effectiveness of the Her Health Program to Add Healthcare Value in the Fourth Trimester
Official title: Testing the Effectiveness of the Her Health Program to Add Healthcare Value in the Fourth Trimester
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Postpartum
Pregnancy Related
Lead sponsor: Woman's
Sponsor class: OTHER
Collaborators: name: Donaghue Medical Research Foundation
First posted: 2024-03-07
Enrollment: 500
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to learn if a program Woman's Hospital has made, called the Her Health Program, can help women be healthy and get healthcare in the first year after having a baby.

The main question\[s\] the study aims to answer are:

* Can the Her Health program increase access to healthcare in the first year postpartum?
* Can the Her Health program increase knowledge about healthcare and change feelings toward the healthcare system?

Participants will complete one research visit in which they will be enrolled and told which group they will be in- "Her Health Program" group or "Usual Care" group. If they are placed in the "Her Health Program" group, they will receive their usual care + the addition of an extra healthcare team member(called a community health navigator) to to work with patients and care team for a year postpartum.

Researchers will compare those who receive the Her Health Program and those who do not receive the program to see if the Her Health Program can help women get healthcare in the first year after having a baby.


Eligibility criteria: Inclusion Criteria:

* At least 16 years old at the time of consent.
* Gave birth within 7 days before randomization
* Medicaid enrolled
* Address of residence within a disadvantaged area (ADI\>5).
* Clearly understands the study procedures and visit schedule, alternative treatments, and risks involved with the study, and voluntarily agrees to participate by giving verbal and written informed consent

Exclusion Criteria:

* Use of private health insurance exclusively
* Does not speak English.
* Plans to move out of state during the study time period
* Unwilling to provide permission to link study records, medical records, and Medicaid and Vital Records Database records.
* Unwilling to provide informed consent
* Unwilling to be randomized.

Primary outcomes:
measure: Postpartum visit attendance
timeFrame: 12 weeks postpartum
Secondary outcomes:
measure: Medical trust
timeFrame: 12 months postpartum
measure: Health literacy
timeFrame: 12 months postpartum
measure: Self-efficacy
timeFrame: 12 months postpartum
measure: Healthcare costs
timeFrame: 12 months postpartum
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Woman's Hospital
state: Louisiana
Study officials:
affiliation: Woman's Hospital, Louisiana
name: Elizabeth Sutton, PhD
role: PRINCIPAL_INVESTIGATOR
References: