louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01718990: Biomarker Discovery for Novel Drug Development in Idiopathic Pulmonary Fibrosis
Official title: Prospective, Longitudinal Cohort Trial of Patients With Idiopathic Pulmonary Fibrosis (IPF) and Healthy Control Patients. Clinical Data, Blood, and Bronchiolavage (BAL) Fluid Will be Collected Over 12 Months.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis (IPF)
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2012-11-01
Enrollment: 110
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IPF

Brief summary: Drug discovery can take many years especially since most studies to measure effectiveness depend on clinical outcomes like pulmonary function tests and hospitalizations.

This is an observational study designed to collect information, blood, and bronchoalveolar lavage fluid in people who have IPF and those who do not. The people who have IPF will be followed for 12 months to collect more biological samples and record clinically relevant information.

The goal of this study is to identify new molecular markers that are measurable and reliable in people who have IPF. It is hoped that these markers can be used in future drug studies to significantly speed up the process of finding drugs that help.


Eligibility criteria: Inclusion Criteria:

* age 35 to 80 years
* a diagnosis of IPF by consensus criteria

Exclusion Criteria:

* any condition that makes the patient at unacceptable risk for bronchoscopy
* the presence of significant co-existing emphysema on HRCT
* active cigarette smoking (defined as smoking within the last 6 months)
* the presence of a significant co-morbidity felt to limit life expectancy to less than 12 months.
* active listing for lung transplantation
* inability to provide informed consent

Primary outcomes:
measure: Molecular Markers
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Harold Collard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01694290: Chemical Ice Packs for Cooling Hyperthermic Patients
Official title: Randomized Controlled Trial Assessing Effectiveness of Chemical Cold Packs Used on Various Skin Surfaces for Cooling Hyperthermic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heat Stroke, Heat Exhaustion
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-09-27
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A common tool to cool people in the pre-hospital setting is the chemical ice pack. These are used by athletic trainers, EMS personnel, ER staff, and people in the prehosoital setting.

The ability of these to cool a person has never been quantified, the efficiency and extent of cooling, as well as location of placement of ice packs is purely anecdotal. The purpose of this study is to determine whether strategically placed chemical ice packs will provide benefit to individuals subjected to heat stress.


Eligibility criteria: Inclusion Criteria:

* young healthy males \> 18 years old with no active medical problems and able to run 10 km.

Exclusion Criteria:

* Active medical problems or inability to exercise for 45 minutes in a heated room.

Primary outcomes:
measure: Core body temperature cooling
timeFrame: 35 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
References:
citation: Lissoway JB, Lipman GS, Grahn DA, Cao VH, Shaheen M, Phan S, Weiss EA, Heller HC. Novel application of chemical cold packs for treatment of exercise-induced hyperthermia: a randomized controlled trial. Wilderness Environ Med. 2015 Jun;26(2):173-9. doi: 10.1016/j.wem.2014.11.006. Epub 2015 Mar 12.
Clinical trial NCT01438190: Metformin in Step-down Regimen Versus Conventional Low Dose Step-up Protocol in Patients With PCOS Undergoing IVF
Official title: A Comparison Study of a Novel Stimulation Protocol With Metformin in Step-down Regimen and the Conventional Low Dose Step-up Protocol in Patients With Polycystic Ovary Syndrome Undergoing in Vitro Fertilization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility
PCOS
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2011-09-22
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Because many women with Polycystic Ovary Syndrome (PCOS) are very sensitive to the use of gonadotropins, several strategies have been proposed to reduce the risk of Ovarian hyperstimulation syndrome (OHSS) and multiple pregnancies.

The low dose step-up protocol and the step-down protocols in PCOS patients have been described in literature.

The step-down regimen is designed to achieve the follicle stimulating hormone (FSH) threshold through a loading dose of FSH with a subsequent stepwise reduction as soon as follicular development is observed on ultrasound. On the contrary the step-up regimen is based upon the principle of a stepwise increase in FSH supply to determine the FSH threshold for follicular development. After commencement of gonadotropin administration, if follicle development is not observed on ultrasound after 1 week, an increase in the dose is recommended. Once follicle growth is observed, the same FSH dose is maintained until follicular selection is achieved.

Preliminary studies report that both step-up and step-down regimens achieve similar high rates of monofollicular development. However, the largest study published so far has shown that the step-up regimen is safer in terms of monofollicular development.

Recent data demonstrate that metformin administration in infertile PCOS patients who are at high-risk for OHSS reduces the incidence and severity of OHSS during gonadotropin ovarian stimulation in a step-down regimen for in vitro fertilization (IVF) programs.

The aim of the present study will be to compare the conventional low dose step-up protocol and the combined protocol consisting in metformin and gonadotropin step-down regimen.


Eligibility criteria: Inclusion Criteria:

* PCOS
* Infertility
* High responders

Exclusion Criteria:

* Poor responders
* Major medical conditions

Primary outcomes:
measure: OHSS rate
timeFrame: one month
Secondary outcomes:
measure: cancellation rate
timeFrame: one month
measure: pregnancy rate
timeFrame: one month
measure: live-birth rate
timeFrame: nine months
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: "Pugliese" Hospital
Study officials:
affiliation: Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
name: Stefano Palomba, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04204590: Feasibility Study of a Systematic Approach for Deprescribing of Statins and PPI's.
Official title: Feasibility Study of a Systematic Approach for Deprescribing of Statins and Proton Pump Inhibitors in Nursing Home Residents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polypharmacy
Keywords: Deprescribing
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A multicentre, unblinded, single group (pre-comparison and post-comparison) feasibility study.
Primary purpose: OTHER

Brief summary: Deprescribing, the process of safely reducing or discontinuing unnecessary or harmful medication, has the potential to decrease polypharmacy and improve health outcomes. In this study a structured implicit algorithm, focusing on both extrinsic medication factors (eg change in disease) and intrinsic patient factors (eg. pill burden) will be used.


Eligibility criteria: Inclusion Criteria:

* Participant uses a statin and/or a proton pump inhibitor.
* Participant signs informed consent.
* Participant is a nursing home resident.

Exclusion Criteria:

* Participant is there for short term nursing home admission (\<3 months)
* Participant is there for hospice admission.

Primary outcomes:
measure: Decrease in pill burden (the number of statins and PPI's)
timeFrame: 3 and 6 months after intervention.
measure: Decrease in pill burden (the dose of statins and PPI's)
timeFrame: 3 and 6 months after intervention.
Secondary outcomes:
measure: All possible negative side effects of deprescribing (e.g. nausea, symptom recurrence)
timeFrame: From intervention to six months after intervention
measure: Feasibility to use this algorithm.
timeFrame: 3 and 6 months after intervention
Other outcomes:
Locations:
city: Sittard
country: Netherlands
facility: Lemborgh
state: Limburg
Study officials:
affiliation: Principal Investigator
name: Jos Schols, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06978790: Generative Artificial Intelligence Nurse Staffing Study
Official title: Generative Artificial Intelligence Nurse Staffing (GAINS) Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Burnout, Healthcare Workers
Lead sponsor: University of Hawaii
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is guided by Maslach's Burnout Theory and with Normalization Process Theory supporting the implementation of the GAINS intervention by facilitating its integration into routine system-level practice. In Year 1, the investigative team will collaborate with hospital-based nursing leadership and key stakeholders to identify staffing-specific factors essential for operationalizing the GAINS AI model/intervention. In Year 1, the investigators will also conduct a survey amongst nursing staff to measure baseline burnout. In Year 2, the AI-staffing intervention will be implemented with the medical-surgical nursing float pool team. In Year 3, the investigators will first repeat the nurse burnout survey and second, expand the intervention to include the nursing assistant float pool team. In Year 4, the investigators will conduct the final burnout survey with nurses, assess feasibility of GAINS (target vs. actual staffing- nurses and nursing assistants), and assess preliminary efficacy of GAINS to reduce costs related to staffing. the investigators will compare outcomes at three time points (pre, mid, and post-intervention). Interviews with nurses, nursing assistants, unit nurse managers, and leadership will further explicate the intervention's acceptability, feasibility, and impact on burnout.


Eligibility criteria: Inclusion Criteria:

* Registered nurses, nursing assistants, or key stakeholders
* Employed by The Queen's Medical Center
* Working at least 24 hours per week
* Position associated with medical-surgical units where float pool nurses work

Exclusion Criteria:

* Employees working less than 24 hours per week at The Queen's Medical Center
* Employees whose roles are not related to medical-surgical units

Primary outcomes:
measure: Maslach's Burnout Inventory
timeFrame: Up to 2.5 years
measure: Qualitative Interviews to Evaluate Feasibility, Normalization, and Acceptability of the GAINS Intervention
timeFrame: Up to 3 years
Secondary outcomes:
measure: Optimization Staffing Rates [Target staffing rate - Actual staffing rate]
timeFrame: Up to 2 years
measure: Total Cost: Travel Nurse and Nurse Overtime
timeFrame: Up to 2 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Hawaii at Manoa
name: Katie A Azama, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01504321: Polycystic Ovary Syndrome - Improving Outcomes
Official title: Polycystic Ovary Syndrome - Targeting the Sympathetic Nervous System to Improve Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary syndrome
PCOS
sympathetic nervous system
moxonidine
Lead sponsor: Baker Heart and Diabetes Institute
Sponsor class: OTHER
First posted: 2012-01-05
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Polycystic ovary syndrome affects a striking 9-18% of Australian reproductive aged women and has been associated with a number of metabolic abnormalities.

Given the strong correlation between metabolic abnormalities and increased sympathetic activity, we hypothesise that reducing this activity using medication (moxonidine) can help improve the metabolic abnormalities, and therefore improve outcomes in polycystic ovary syndrome.


Eligibility criteria: Inclusion Criteria:

* Overweight and class I obese pre-menopausal women
* Diagnosis of PCOS by Rotterdam criteria

Exclusion Criteria:

* Any current medication
* pregnancy or the desire to become pregnant
* BMI \> 35
* a history of type I diabetes, secondary hypertension not due to PCOS
* cardiovascular, cerebrovascular, liver or thyroid disease
* severe mental illness.

Primary outcomes:
measure: Microneurography
timeFrame: 3 months
Secondary outcomes:
measure: Blood biochemistry measurement
timeFrame: 3 months
measure: Oral glucose tolerance test
timeFrame: 3 months
Other outcomes:
Locations:
city: Prahran
country: Australia
facility: Heart Centre, Alfred Hospital
state: Victoria
Study officials:
affiliation: BakerIDI Heart and Diabetes Institute
name: Gavin Lambert, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jewson J, Lambert E, Sari C, Jona E, Shorakae S, Lambert G, Gaida J. Does moxonidine reduce Achilles tendon or musculoskeletal pain in women with polycystic ovarian syndrome? A secondary analysis of a randomised controlled trial. BMC Endocr Disord. 2020 Aug 26;20(1):131. doi: 10.1186/s12902-020-00610-8.
citation: Shorakae S, Jona E, de Courten B, Lambert GW, Lambert EA, Phillips SE, Clarke IJ, Teede HJ, Henry BA. Brown adipose tissue thermogenesis in polycystic ovary syndrome. Clin Endocrinol (Oxf). 2019 Mar;90(3):425-432. doi: 10.1111/cen.13913. Epub 2019 Jan 7.
citation: Shorakae S, Lambert EA, Jona E, Ika Sari C, de Courten B, Dixon JB, Lambert GW, Teede HJ. Effect of Central Sympathoinhibition With Moxonidine on Sympathetic Nervous Activity in Polycystic Ovary Syndrome-A Randomized Controlled Trial. Front Physiol. 2018 Oct 25;9:1486. doi: 10.3389/fphys.2018.01486. eCollection 2018.
Clinical trial NCT07004621: Videolaryngoscopy Versus Direct Laryngoscopy for Endotracheal Intubation of Obese Patients: a Prospective Randomized Trial
Official title: Videolaryngoscopy Versus Direct Laryngoscopy for Endotracheal Intubation of Obese Patients: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubating Laryngeal Airway
Keywords: laryngoscopy
tracheal intubation
o besity patients ,
v ideolaryngoscopes
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study group will be male and female patients, ASA II or III, over 18 years of age and under 75 years of age. Each patient will undergo abdominal (bariatric) surgery.
Primary purpose: DIAGNOSTIC

Brief summary: Patients were randomly assigned (1:1) to either a Macintosh laryngoscope group ("Macintosh group") or a videolaryngoscope group ("Video group").

Detailed description: In the Macintosh group, intubation was performed with a standard curved Macintosh blade. In the Video group, intubation was performed with the assigned videolaryngoscope. If intubation proved difficult with the initially assigned device, anaesthesiologists could switch to the alternative method at their discretion (rescue technique).

Eligibility criteria: • Inclusion criteria: Adult patients (\> 18 years) of both sexes with BMI \> 35 kg/m² scheduled for laparoscopic sleeve gastrectomy (ASA \< IV).

• Exclusion criteria:

* Patient's refusal to participate.
* Known allergy to drugs used during anaesthesia.
* Chronic pain syndromes.
* Chronic opioid use.

Primary outcomes:
measure: determine whether modern technologies such as videolaryngoscopy shorten intubation time.
timeFrame: 1 day
Secondary outcomes:
measure: complications
timeFrame: 1 day
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: SP ZOZ Szpital Uniwersytecki w Krakowie
state: Malopolskie
Study officials:
References:
citation: Yumul R, Elvir-Lazo OL, White PF, Sloninsky A, Kaplan M, Kariger R, Naruse R, Parker N, Pham C, Zhang X, Wender RH. Comparison of three video laryngoscopy devices to direct laryngoscopy for intubating obese patients: a randomized controlled trial. J Clin Anesth. 2016 Jun;31:71-7. doi: 10.1016/j.jclinane.2015.12.042. Epub 2016 Mar 23.
Clinical trial NCT03083821: A Study to Provide a Better Understanding of Baraclude's Pharmacokinetic Properties in a Real World Clinical Setting
Official title: A Clinical Study to Evaluate the Steady State Pharmacokinetics of Baraclude in Participants With Hepatitis B Virus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis B Virus
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-03-20
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Pharmacokinetics study of Baraclude in a real world clinical setting in Japan.


Eligibility criteria: Inclusion Criteria:

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

* Participants with chronic hepatitis B (CHB) (excluding participants with a superinfection) who have been confirmed to have CHB.
* Participants who are being treated with 0.5 mg daily Baraclude for a minimum of 10 consecutive days prior to the study enrollment.
* Body mass index (BMI) of 18.5 to 30 kg/m2 (BMI = body weight \[kg\]/height \[m\]2)

Exclusion Criteria:

* Current or recent (within 3 months of Baraclude administration) gastrointestinal disease that could impact upon the absorption of study drug.
* Any gastrointestinal surgery that could impact upon the absorption of study drug.
* Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only).

Other protocol defined inclusion/exclusion criteria could apply.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Up to 24 hours
measure: Time of Maximum Observed Plasma Concentration (Tmax)
timeFrame: Up to 24 hours
measure: Trough Observed Plasma (Predose) Concentration (Ctrough)
timeFrame: prior to administration of drug (predose)
measure: Observed Plasma Concentration at 24 Hours Postdose (C24)
timeFrame: 24 hours post-dose
measure: Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)]
timeFrame: Up to 24 hours
measure: Apparent Total Body Clearance (CLT/F)
timeFrame: Up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hachioji-shi
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00366821: Retrospective Review of the Outcomes of Newborns With Genetic Abnormalities
Official title: Retrospective Review of the Outcomes of Newborns With Genetic Abnormalities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Disorders
Keywords: cardiac
pediatric
genetic
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2006-08-21
Enrollment: 1000
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients' charts will be reviewed from Children's Healtcare of Atlanta between January 1, 2002 through December 31, 2006 of all neonates who underwent cardiac surgery.

Brief summary: Our hope is that the information from this retrospective study will provide information to better serve our patients and their parents with risk stratification (levels of risk) and clinical expectations of patients after cardiac surgery who have genetic abnormalities and those who do not have genetic abnormalities.

Detailed description: Screening for genetic/chromosomal abnormalities has become more frequent both pre-natally and post-natally. Therefore, we plan to review the outcomes in newborns with genetic abnormalities after cardiac surgery compared to those newborns without genetic abnormalities after cardiac surgery.

We wish to examine the outcomes following cardiac surgery in newborns with genetic abnormalities compared to those newborns without genetic abnormalities. We will compare morality rates and co-morbidities in each group.

We will retrospectively review the cardiac surgical database and patient medical records for all neonates (newborns \< 30 days of age) who underwent cardiac surgery from January 1, 2002 through May 31, 2006 at Children's Healthcare of Atlanta. We plan to collect data on approximately 1000 patients including date of birth, age, weight, gestation, prenatal diagnosis, genetic abnormality, cardiac defect, surgery, operative details, pre-op and post-op complications, length of time on ventilator, hospital stay and mortality for these patients.

We will review the patient outcome data available after their initial surgery through May 31, 2006. No patients will be contacted.

Eligibility criteria: Inclusion Criteria:

* neonates (newborns\< 30 days of age)
* cardiac surgery between 1/1/02 - 5/31/06
* at Children's Healthcare of Atlanta

Exclusion Criteria:

* those who do not meet inclusion criteria

Primary outcomes:
measure: We wish to examine the outcomes following cardiac surgery in newborns with genetic abnormalities compared to those newborns without genetic abnormalities.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Children's Healthcare of Atlanta
name: Janet M Simsic, MD
role: PRINCIPAL_INVESTIGATOR
References: