louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01096303: Effects of Marijuana Used on Lung Function in Persons With Chronic Obstructive Pulmonary Disease (COPD)
Official title: Effects of Marijuana Smoking on Pulmonary Function in Patients With COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
pulmonary function
tobacco and marihuana smoking
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2010-03-31
Enrollment: 200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients recruited in pulmonary clinic.

Brief summary: The main hypothesis is that persons that smoke or smoked tobacco and marihuana have worsen lung function as compared with persons that only smoke or smoked tobacco.

Detailed description: We will follow persons with already diagnosed COPD (chronic bronchitis and/or emphysema). Obtain their smoking history: tobacco and marihuana and review their pulmonary function study results. Then we are planning to compare both groups.

Eligibility criteria: Inclusion Criteria:

* COPD patients former or current tobacco smokers
* COPD patients former or current tobacco and marihuana smokers

Exclusion Criteria:

* History of COPD without pulmonary function testing
* Refusal to provide smoking or marihuana used history

Primary outcomes:
measure: Obstructive limitation in pulmonary function test
timeFrame: 1 year
Secondary outcomes:
measure: Decreased diffusion capacity for carbon monoxide
timeFrame: 1 year
measure: Airtrapping
timeFrame: 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon B Johnson General Hospital
state: Texas
city: Houston
country: United States
facility: The University of Texas- Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Rosa M Estrada-Y-Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05824403: PAncreatic Disease Cohort of TOuLouse
Official title: PAncreatic Disease Cohort of TOuLouse
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Diseases
Keywords: Pancreatic cyst
Acute pancreatitis
chronic pancreatitis
Intra Pancreatic Mucinous Neoplasia
diagnosis
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pancreatic disease

Brief summary: This study is a prospective cohort dedicated to pancreatic diseases excluding cancer. The aim is to develop positive or differential diagnostic tools between benign potentially malignant or malignant pancreatic pathologies. During this study the investigators collect data and biological samples to support research project.

Detailed description: This collection focuses on pathology of the pancreas requiring specific investigations or management for diagnosis or treatment. Pancreatic pathologies can be classified as malignant, potentially malignant or benign tumors. These can be solid or cystic. There is an inflammatory attack on the pancreas, generating acute pancreatitis in the acute period, if the inflammatory manifestations persist, chronic pancreatitis will develop. Some lesions may be at risk of malignancy during their evolution, it is therefore necessary to improve the performance of monitoring and diagnostic tools in order to adapt the management of patients.

Eligibility criteria: Inclusion Criteria:

* Patients with inflammatory or cystic exocrine pancreatic pathology
* Patient able to read and understand the information leaflet
* Patients who have agreed to participate in the study and have signed the free and informed consent
* Patients affiliated to a social security system (including AME)

Exclusion Criteria:

* Patient with pancreatic cancer pathology
* Patients with active cancer, whatever the origin
* Pregnant or breastfeeding patients
* Patients under legal protection, guardianship or trusteeship

Primary outcomes:
measure: Diagnostic tools
timeFrame: 3 years after the first inclusion
Secondary outcomes:
measure: New targets
timeFrame: 3 years after the first inclusion
measure: Improvement of management
timeFrame: 3 years after the first inclusion
measure: Microbiota
timeFrame: 3 years after the first inclusion
measure: Clinical data access
timeFrame: 3 years after the first inclusion
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Rangueil hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Barbara BOURNET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06913803: To Find Effectiveness of Stretching Versus Soft Tissue Mobilization in Coccydynia in Postpartum Females
Official title: To Find Effectiveness of Stretching Versus Soft Tissue Mobilization in Coccydynia in Postpartum Females
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coccidioidomycosis
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 46
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This research is to determine the effectiveness of stretching versus soft tissue mobilization in coccydynia patients.The main purpose of the study is the the development of evidence based therapeutic protocols for postpartum coccydynia patients to improve functional impairment, range of motion, and reduction of pain.

Detailed description: The study design is randomized controlled trial.The interventions were carried out twice a week for three weeks with each session lasting approximately 20 min.Group A contains 34 patients and received STM focusing on mobilizing soft tissue to enhance circulation reduce scar tissue and improve functional flexibility.Group B received both STM and stretching twice a week for three weeks with each session lasting approximately 20 min.During entire treatment the therapist kept close eye on patient discomfort.The significance of the study lies in it's potential to enhance more effective non invasive treatment to alleviate symptoms

Eligibility criteria: Inclusion Criteria:

* diagnosed by orthopedic surgeon with sign and symptoms of coccydynia and radiograph X ray for confirmation.: postpartum females after 2 to 3 months after delivery
* office working females
* aged 20 to 35 years
* females with c section

Exclusion Criteria:

* FEMALES with vaginal delivery
* experience severe post operative pain
* active pelvic or abdominal infections
* ovarian cyst, fibroids,or obstructive endometrial polyps
* neurological conditions

Primary outcomes:
measure: NUMERIC PAIN RATING SCALE(NPRS)
timeFrame: 12 Months
measure: Oswestry Disability Index (ODI)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Sir Ganga Ram Hospital Physiotherapy department , Mozang
state: Punjab
Study officials:
References:
Clinical trial NCT01912703: The Long-term Neurodevelopmental Outcome After Intraventricular Hemorrhage (IVH)-Grades I-II in Preterm Infants at Ages 1-7 Years
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premature Infants
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-07-31
Enrollment: 700
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants born in 2007-2011 at the Hillel Yaffe Medical Center

Brief summary: It is well-known that preterm delivery can be accompanied by complications. One of these complications is Intraventricular Hemorrhage (IVH). There are four degrees of IVH, according to severity. It is known that IVH Grades 3-4 can cause severe neurodevelopmental outcomes, including cerebral palsy (CP), hemiplegia, lower motor and cognitive skills and social difficulties. It is not known whether IVH Grades I-II have any of these effects and the aim of this study is to determine whether they do have any neurodevelopmental outcomes.


Eligibility criteria: Inclusion Criteria:

* All preterm infants born at 35 weeks or less
* Underwent at least 1 brain ultrasound
* Diagnosed with IVH Grades 1-2
* Had no other severe illness in NICU
* Had neurodevelopmental follow-up

Exclusion Criteria:

* All others

Primary outcomes:
measure: General Neurodevelopmental Assessment
timeFrame: Seven years
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT06895603: The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial (Cardiac Output Study)
Official title: The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial (Cardiac Output Study)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: ICU
Surgical Patients
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2025-03-26
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 75 ICU patients being monitored with a PAC and radial arterial line will be enrolled over approximately 8 months accrual and follow-up evaluation period

Brief summary: The purpose of this study is to compare cardiac output (CO), fluid responsiveness, and related measurements between the Philips AMC and PAC (Swan-Ganz) in ICU or surgical patients.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years and older
* Indication for PAC (Swan-Ganz)
* Indication for radial arterial line
* Subject or legal authorized representative is able to understand and speak the local language (also Spanish is also accepted for US sites) to provide voluntary written informed consent prior to study procedures

Exclusion Criteria:

* Emergency surgery
* ICU or surgical positioning where both arms are tucked
* Inability to place the Philips AMC appropriately due to subject anatomy or condition
* Known pregnancy or lactating women (self-report)
* Patients treated with an intra-aortic balloon pump
* Measurements taken in the lateral position
* Currently participating in an investigational drug or another device study that clinically interferes with the study endpoints
* Upper arm circumference \< 19 cm or \> 43 cm
* BMI \> 45
* At the PI's discretion, subject does not qualify to participate in the study for any reasons that are not mentioned above

Primary outcomes:
measure: Primary Endpoints
timeFrame: Approximately 8 months for accrual and follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00689403: Evaluate Different Extended-release (ER) Tablets/Capsules of AZD1305
Official title: A Phase I, Two-part, Randomised, Open, Single-centre, Crossover Study to Evaluate Different Extended-release Formulations of AZD1305 When Given as Single Oral Doses to Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: AZD1305
pharmacokinetics
Properties of different ER formulations
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 50
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To study the properties of different tablets/capsules of AZD1305 in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male between the age of 20 - 45
* Non-smoking

Exclusion Criteria:

* Potassium outside normal reference values
* ECG findings outside normal range

Primary outcomes:
measure: Pharmacokinetic variables
timeFrame: During all dosing visits
Secondary outcomes:
measure: Adverse events, ECG, safety laboratory, vital signs, physical examination
timeFrame: During the study
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Mölndal, Sweden
name: Helen Lunde, MD
role: STUDY_DIRECTOR
affiliation: PAREXEL Clinical Pharmacology Research UnitHarrow, United Kingdom
name: Daniel Bradford, MD, MA, MBBS, DCPSA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05751603: Effectiveness on Smooth Extubation According to the Administration Time of Sugammadex
Official title: Comparison of Smooth Emergence During Extubation After Anesthesia When Sugammadex is Administered Before and After Extubation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sugammadex
Extubation
Smooth Emergence
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 66
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: After surgery is completed under general anesthesia, extubation is performed after recovery from anesthesia, and during this process, bucking, coughing, and rapid and excessive hemodynamic fluctuations occur very often. These phenomena can lead to high intrathoracic pressure, venous congestion, hematoma formation, or increased bleeding after major neck surgery. (1) They can also increase the risk of aerosol generation, which can transmit infection to health care workers. (2) For this, smooth extubation is required. Methods of administering drugs such as lidocaine, opioids, or dexmedetomidine have been proposed for smooth extubation. (3-5) As a disadvantage, the use of these drugs may be associated with deep sedation and reduced airway reflexes .

Recently, Babu et al. (6) reported that bucking and coughing during extubation could be reduced by changing the timing of administering a muscle relaxant antagonist rather than using these sedative drugs, and thus complications related to extubation could be reduced. In general, in the awakening process, it was common to administer the muscle relaxant at the point of recovery of spontaneous breathing. However, Babu et al. demonstrated the possibility of safe and smooth extubation by changing the timing of administering neostigmine without the use of sedatives or narcotic analgesics, but there are few studies on sugammadex.

Therefore, when recovering from general anesthesia, sugammadex was administered before and immediately after extubation to evaluate and compare smooth extubation (ie, comparison of the frequency of bucking and coughing).


Eligibility criteria: Inclusion Criteria:

* patients undergoing general anesthesia for thyroid surgery.
* aged between 19 and 64 years
* American Society of Anesthesiologists physical status I and II

Exclusion Criteria:

* patients with malformation or tumor of the upper respiratory tract
* patients with risk of aspiration
* obese cases with a BMI \> 35
* patients in which tracheal intubation was difficult
* refusal to participate in research

Primary outcomes:
measure: extubation quality score
timeFrame: immediate after extubation
Secondary outcomes:
measure: time to respiration
timeFrame: immediate after extubation
measure: time to extubation
timeFrame: immediate after extubation
measure: sore throat in postanesthetic care unit
timeFrame: in postanesthetic care unit
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05239403: Association Between Gut Microbiome and Dietary Determinants and Vaccine Response
Official title: Delineating Gut Microbiome and Dietary Determinants Associated With Favorable Vaccine Response
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Influenza
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-02-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MD Anderson employees

Brief summary: This study evaluates the association between gut microbiome and dietary determinants and vaccine response. This study aims to learn if diet and the microbes (such as bacteria and viruses) found in your gut affect the body's immune response to the influenza vaccine.

Detailed description: PRIMARY OBJECTIVE:

I. To evaluate the association of gut microbiome diversity with response to influenza vaccination as measured by vaccine-specific immune response.

SECONDARY OBJECTIVE:

I. To determine the gut microbial signatures and dietary patterns associated with response to influenza vaccination as measured by vaccine-specific post vaccine serum titers.

EXPLORATORY OBJECTIVES:

I. Interrogation of the overlap between the identified signature and excellent or poor responses to cancer immunotherapy (from our own published work and internal cohorts).

II. Identify components and determinants of the gut microbiome that could be modulated to enhance vaccine response.

OUTLINE:

Participants complete questionnaires over 10-15 minutes up to 4 weeks prior to day of vaccination and undergo collection of blood samples up to 4 weeks before or on the day of vaccination and within 3 weeks post vaccination. Patients may also undergo collection of stool samples up to 4 weeks prior to day of vaccination.

Eligibility criteria: Inclusion Criteria:

1. MD Anderson employees and student employees with existing MRN
2. Must be able to donate blood
3. Participants must be age 18 or older
4. Participants must receive the seasonal influenza vaccine at MD Anderson through Employee Health
5. Participants must consent to gut microbiome profiling, REDCap-based dietary screening questionnaire (Appendix A) and survey (Appendix B), and vaccine immune response testing which requires one stool sample, and two blood draws

Exclusion Criteria:

1. Participants with a contraindication to the recommended annual influenza vaccine

Pregnant women may be included in this study.

Primary outcomes:
measure: Correlation between fecal microbiome diversity and seroconversion following influenza vaccination
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
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: Jennifer Wargo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00006203: Naltrexone, Craving, and Drinking
Official title: Naltrexone, Craving, and Drinking: Ecological Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcoholism
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2000-09-12
Enrollment: 180
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After a one-week placebo lead-in period, drinkers were randomized to 3 weeks of daily naltrexone or placebo.
Primary purpose: TREATMENT

Brief summary: This 5-week study will examine the effects of naltrexone on alcohol craving, drinking rates, and reaction to drinking-related triggers, or cues, in participants' everyday environment and in laboratory sessions. Participants will monitor and record their daily desires to drink, environmental circumstances in which urges occur, and drinking behavior using a palm top computer. Participants will receive naltrexone or a placebo. One week after receiving medication, all participants will be asked to respond to alcohol-related cues that may or may not arouse the desire to drink.


Eligibility criteria: Inclusion Criteria:

* Drink at least 4 days per week with 2 heavy drinking days (more than 6 standard drinks for men, more than 5 drinks for women) per week on average during the month prior to the study.

Exclusion Criteria:

* Current interest in treatment or a history of treatment for alcohol problems.
* History of liver disease or current liver function tests greater than five times normal.
* Opiate abuse or dependence, any opiate use two weeks before the study or a urine test screen that is positive for opiates.
* Females, who are pregnant, nursing, or not using reliable birth control method.
* Daily use of acetaminophen.
* Living with someone who participated in this study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Center for Alcohol and Addiction Studies, Brown University
state: Rhode Island
Study officials:
References:
Clinical trial NCT04104503: A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects
Official title: Interventional, Open-label, Two-part, Partly-randomized Study Investigating the Pharmacokinetic Properties, Absolute Bioavailability, Food Effect, and Intra-subject Variability of up to 5 Prototype Modified-release Tablet Formulations of Lu AF11167 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2019-09-26
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the extent to which Lu AF11167 enters the bloodstream following tablet intake and the influence of food on uptake in healthy men and women

Detailed description: This study will be split into Part A and Part B. Part A will happen first and will look at new tablet formulations of the test medicine compared to a previously known formulation (reference tablet). The results from Part A of the study will be used to decide which formulation will be tested in Part B of the study. Part B of the study will look at the food effect, variability between participants, and absolute bioavailability of the test medicine i.e. how much of the test medicine is taken up by the body when dosed by mouth compared to when dosed once by injection directly into the vein. Safety and tolerability will be assessed throughout the study.

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) of ≥18.5 and ≤30.0 kg/m2
* (Part B only) Women of child-bearing potential will have a confirmed non-pregnant and non-lactating status

Exclusion Criteria:

* The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the investigational medical product

Other in- and exclusion criteria may apply

Primary outcomes:
measure: Cmax of Lu AF11167
timeFrame: From 0 to 48 hours
measure: AUC(0-inf) of Lu AF11167
timeFrame: From 0 to 48 hours
measure: Relative bioavailability F(rel) of Lu AF11167
timeFrame: From 0 to 48 hours
measure: Absolute bioavailability F(abs) of Lu AF11167
timeFrame: From 0 to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: