louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01878968: Does Detailed Informed Consent for Cardiopulmonary Resuscitation and Mechanical Ventilation Impact Patients' Decisions and Outcomes?
Official title: Does Detailed Informed Consent for Cardiopulmonary Resuscitation and Mechanical Ventilation Impact Patients' Decisions and Outcomes?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Infections
Sepsis
Acute Renal Failure
Stroke
Lead sponsor: Jewish Hospital, Cincinnati, Ohio
Sponsor class: OTHER
First posted: 2013-06-17
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: There is evidence to suggest that patients make different end-of-life decisions if they understand the risks, benefits and alternatives of CPR and mechanical ventilation. This study will examine whether evidence-based informed consent impacts patients choices and healthcare outcomes compared to routine care.


Eligibility criteria: Inclusion Criteria:

* All patients
* ≥65 yrs
* Admitted to the hospitalist Medicine Service

Exclusion Criteria:

* Patients who have pre-existing, pan-institutional (e.g. to be applied at nursing homes and hospitals) orders of no CPR and/or no mechanical ventilation will be screened (demographic and outcomes data collected) but NOT randomized.
* Patients already receiving critical care on admission will also be excluded

Primary outcomes:
measure: Number of patients opting out of routine care - no intubation
timeFrame: 48 hours
measure: Number of patients opting out of routine care - no CPR
timeFrame: 48 hours
Secondary outcomes:
measure: Hospital Mortality
timeFrame: Length of patient's hospital stay
measure: 30-day mortality
timeFrame: 30 days
measure: 90 day mortality
timeFrame: 90 days
measure: Number of patients undergoing CPR
timeFrame: Length of patient's hospital stay
measure: Number of patients undergoing intubation
timeFrame: Length of patient's hospital stay
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: The Jewish Hospital
state: Ohio
Study officials:
affiliation: Jewish Hospital of Cincinnati
name: Imran Naqvi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05672368: The da Vinci Single Port Robotic System for Use in Abdominal and Pelvic Surgical Procedures
Official title: Phase II Study of the Da Vinci Single Port (SP) Robotic System for Abdominal and Pelvic Procedures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Disease or Disorder
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-01-05
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This phase II trial test the effectiveness and safety of a single-port robotic device (the da Vinci single port \[SP\]1098) for use in abdominal and pelvic surgeries. The da Vinci SP1098 robotic device can be used to perform less invasive surgeries that allow entry into the body through a single, small incision. The use of this device during surgery may allow surgeons to perform complex procedures that result in less pain, fewer complications and side effects, and improved recovery.

Detailed description: PRIMARY OBJECTIVE:

I. To evaluate the effectiveness and safety for abdominal and pelvic procedures of a single-port robotic device (da Vinci SP1098) that is Food and Drug Administration (FDA)-approved for other indications, specifically urological and transoral otolaryngology surgical procedures.

OUTLINE:

Patients undergo surgery using the da Vinci SP1098 robotic system on study.

Eligibility criteria: Inclusion Criteria:

* Documented informed consent of the participant and/or legally authorized representative
* Any patient scheduled to undergo robot-assisted abdominal or pelvic procedures
* Age \> 18 years

Exclusion Criteria:

* Body mass index (BMI) \> 45
* Contraindications to minimally invasive surgery including chronic obstructive pulmonary disorders
* Past history of failed attempt of minimally invasive abdominal or pelvic surgery

Primary outcomes:
measure: Conversion of operation to laparotomy
timeFrame: Within 30 days of operation
measure: Incidence of major surgical complications
timeFrame: Within 30 days of operation
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
Study officials:
affiliation: City of Hope Comprehensive Cancer Center
name: Mehdi Moslemi-Kebria
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05907668: A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease
Official title: IMVT-1401-2501: A Proof-of-Concept, Open-label Study to Assess the Safety and Efficacy of Batoclimab in Participants With Graves' Disease (GD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Graves Disease
Keywords: Graves' Disease
IMVT-1401
Batoclimab
Hyperthyroidism
Lead sponsor: Immunovant Sciences GmbH
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 35
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: The purpose of this study is to assess the efficacy and safety of 24 weeks of treatment with batoclimab in adult participants with biochemically documented hyperthyroidism due to GD who have failed to achieve euthyroidism on antithyroid drugs (ATDs).


Eligibility criteria: Inclusion Criteria:

* Have serologically confirmed GD as documented by presence of elevated stimulatory thyrotropin receptor antibody (TSH-R-Ab) level (i.e., \> specimen-to-reference ratio of 140%) at the Screening Visit.
* Have active hyperthyroidism due to GD with the following laboratory values at the Screening Visit:

  * TSH \< LLN
  * FT3 \> upper limit of normal (ULN) and \<=5 \* ULN
  * FT4 \> ULN and \<=5 \* ULN

Note: Participants who have T3 thyrotoxicosis (i.e TSH \<LLN, FT3 \> ULN and ≤5× ULN, but FT4 within normal range) at the Screening Visit may be enrolled, if they have serologically confirmed GD as per Inclusion Criterion 1.

* Are willing and capable of giving written informed consent, which includes being able to comply with all aspects of the study treatment and testing schedule.

Exclusion Criteria:

* History of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter), and/or history or presence of thyroid storm.
* History of treatment with radioactive iodine or thyroid surgery.
* Total immunoglobulin G (IgG) level \<6 grams per liter (g/L) at the Screening Visit.
* Albumin level \<3.5 grams per deciliter (g/dL) (\<35 g/L) at the Screening Visit.
* Absolute neutrophil count \<1000 cells per cubic millimeter (cells/mm\^3) at the Screening Visit.

Other, more specific exclusion criteria are defined in the protocol.

Primary outcomes:
measure: Percentage of participants who achieve normalization of free triiodothyronine (FT3) and free thyroxine (FT4), or have FT3 and/or FT4 below the lower limit of normal (LLN) at week 24 without increase in ATD dose
timeFrame: At Week 24
Secondary outcomes:
measure: Percentage of participants who achieve normalization of FT3 and FT4 at Week 24 with ATD dose <= 50% of the ATD dose at Week 24
timeFrame: At Week 24
measure: Percentage of participants who are off ATD treatment and achieve normalization of FT3 and FT4, or have FT3 and/or FT4 below the LLN at Week 24
timeFrame: At Week 24
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Site Number - 6505
Study officials:
References:
Clinical trial NCT02841072: Chart Review Study of Medical Abortion
Official title: Chart Review Study of Medical Abortion at 64-70 Days of Gestation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abortion, Medical
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 579
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted at US abortion clinics that have offered medical abortion with 200 mg mifepristone + 800 mcg buccal misoprostol to at least 20 women at 64-70 days of gestation. Designated staff at each site will review clinic records to identify and record data from every patient treated in that gestational week.

Brief summary: The primary objective of this study is to document the rates of success and serious complications among women having outpatient medical abortions with 200 mg mifepristone + 800 buccal misoprostol at 64-70 days of gestation.

Detailed description: The study will be conducted at US abortion clinics that have offered medical abortion with 200 mg mifepristone + 800 mcg buccal misoprostol to at least 20 women at 64-70 days of gestation. Designated staff at each site will review clinic records to identify and record data from every patient treated in that gestational week. Once data collection is completed, if the rate of success or serious complications at any clinic is substantially discordant from rates documented in the published literature, we may collect additional data on patients seeking medical abortion at 57-63 days, to aid in explaining results found in the 64-70 days group. In this situation, for each patient in the 64-70 days group, site staff will identify and record data from the next consecutive patient treated with this regimen at 57-63 days.

Eligibility criteria: Inclusion Criteria:

* Women at 64-70 days of gestation
* Received 200 mg mifepristone + 800 mcg buccal misoprostol for a medical abortion

Exclusion Criteria:

* Does not meet the inclusion criteria

Primary outcomes:
measure: Abortion Success
timeFrame: 1 week
measure: Serious complications
timeFrame: 1 month
Secondary outcomes:
measure: Proportion of ongoing pregnancies
timeFrame: 1 week
measure: Proportion of complete abortions without additional treatment
timeFrame: 1 week
measure: Proportion of significant abortion complications
timeFrame: 1 month
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Family Planning Associates- Northwest Chicago
state: Illinois
city: Chicago
country: United States
facility: Family Planning Associates- Downtown Chicago
state: Illinois
Study officials:
affiliation: Gynuity Health Projects
name: Elizabeth Raymond, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03403972: Evaluate the Effects of the Environmental Change in Intestine by Antibiotics on the Pharmacokinetic Characteristics of Simvastatin in Healthy Male Volunteers
Official title: A Clinical Trial to Evaluate the Effects of the Environmental Change in Intestine by Antibiotics on the Pharmacokinetic Characteristics of Simvastatin in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Simvastatin Pharmacokinetics and Gut Microbiome
Keywords: pharmacokinetics
simvastatin
vancomycin
gut microbiome
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 6
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This phase 1 clinical trial is to evaluate the effects of the environmental change in intestine by antibiotics on the pharmacokinetic characteristics of simvastatin in healthy male volunteers. For change of intestine environment, especially the gut microbiota, investigators will administer PO vancomycin for 7 days, tid.


Eligibility criteria: Inclusion Criteria:

* Age between 19 Y to 50 Y at the screening
* Body weight over 55 kg and BMI should be between 18.0 to 25.0 kg/m2
* Informed consent will be taken before all the procedures from volunteers
* SLCO1B1 genotype is \*1/\*1 when screening

Exclusion Criteria:

* No significant disease history or ongoing disease
* Allergic to simvastatin and vancomycin, or similar affiliation drug for simvastatin or vancomycin
* MDRD eGFR less than 60 mL/min/1.73m2
* Total cholesterol, LDL, TG is higher than 1.5 times more than upper normal limit at the screening
* HDL less than 35 mg/dL at the screening
* Positive HBV or HIV or HCV
* Who is administering or going to administer CYP3A4 inihibitor drug
* Other clinically significant situation under doctor's opinion

Primary outcomes:
measure: Compare the maximum plasma concentration (Cmax)
timeFrame: vancomycin PO will administered for 7 days
measure: Compare the area under the time-plasma concentration curve (AUC)
timeFrame: vancomycin PO will administered for 7 days
Secondary outcomes:
measure: Explore the gut microbiome species change
timeFrame: vancomycin PO will administered for 7 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital Clinical Trial Center
Study officials:
affiliation: Seoul National University Hospital
name: SeungHwan Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03489772: Study of ITI-214 in Healthy Volunteers to Determine CNS Engagement
Official title: A Randomized, Placebo-Controlled, Double-Blind Study of Escalating Single Doses of ITI-214 in Healthy Volunteers to Determine Central Nervous System Engagement, Safety and Tolerability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Intra-Cellular Therapies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Laureate Institute for Brain Research, Inc.
First posted: 2018-04-05
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a single site, randomized, double-blind, placebo-controlled, within-subjects study design in healthy volunteers. Escalating single doses of ITI-214 will be evaluated using functional magnetic resonance imaging (fMRI) to determine central nervous system engagement. Safety and tolerability also will be assessed.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female, 18 - 45 years
* Fluent and literate in English and able to provide written informed consent
* BMI between 18.5 and 38.0 kg/m2 and minimum body weight of 50 kg

Exclusion Criteria:

* Recent exposure to any investigational product
* Previous exposure to relevant fMRI task(s)
* Considered medically unsuitable for participation
* Has any contraindication for BOLD fMRI

Primary outcomes:
measure: BOLD MRI signals in the anterior insula during the extinction phase of a Fear Conditioning task
timeFrame: 1-3 hours post-dose
measure: BOLD MRI signals in the inferior frontal gyrus during the Stop Signal Task
timeFrame: 1-3 hours post-dose
Secondary outcomes:
measure: BOLD fMRI signals elicited by fear conditioning stimulus
timeFrame: 1-3 hours post-dose
measure: BOLD fMRI signals elicited by the Stop versus Go signal
timeFrame: 1-3 hours post-dose
measure: Number of subjects with reported or observed treatment-related adverse events
timeFrame: 0-5 hours post-dose
Other outcomes:
measure: BOLD fMRI signals elicited in the amygdala, insula and medial prefrontal cortex
timeFrame: 1-3 hours post-dose
Locations:
city: Tulsa
country: United States
facility: Laureate Institute for Brain Research, Inc.
state: Oklahoma
Study officials:
affiliation: Intra-Cellular Therapies, Inc.
name: Robert Davis, PhD
role: STUDY_DIRECTOR
References:
citation: Khalsa SS, Victor TA, Kuplicki R, Yeh HW, Vanover KE, Paulus MP, Davis RE. Single doses of a highly selective inhibitor of phosphodiesterase 1 (lenrispodun) in healthy volunteers: a randomized pharmaco-fMRI clinical trial. Neuropsychopharmacology. 2022 Sep;47(10):1844-1853. doi: 10.1038/s41386-022-01331-3. Epub 2022 Apr 29.
Clinical trial NCT02796872: The Effect of Feeding Infant Formula With Bimuno Galactooligosaccharide (GOS)
Official title: The Effect of Feeding Infant Formula With Bimuno Galactooligosaccharide (GOS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Lead sponsor: Clasado
Sponsor class: INDUSTRY
First posted: 2016-06-13
Enrollment: 392
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This survey is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective trial and is intended to evaluate the Bimuno GOS effects on growth, tolerance, gut health, fecal flora and immune function.


Eligibility criteria: Inclusion Criteria:

* o 15 ± 3 days of age at randomization, inclusive (day of birth is considered day 0)

  * Singleton birth
  * Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age)
  * Birth weight of 2500g to 4000g
  * Signed informed consent obtained for infant's participation in the survey
  * Parent or guardian of infant agrees not to enroll infant in another interventional clinical research survey while participating in this survey
  * APGAR score after 5 minutes of life \> 7
  * Consuming only one source of nutrition
  * Formula-fed infant: Infant consuming infant formula as the sole source of nutrition for 7 consecutive days prior to randomization
  * Breastfed infant: Infant consuming mother's breast milk as the sole source of nutrition for 7 consecutive days prior to registration

Exclusion Criteria:

* Infant with inborn malformation and with hereditary and/or chronic and/or inborn diseases requiring hospital care superior to 7 days
* Diseases jeopardizing intrauterine growth
* Weight at Visit 1 is \<95% of birth weight \[(weight at Visit 1÷birth weight) x 100 \<95%\]
* Infant born from mother suffering from metabolic and/or chronic diseases
* Infant with an acute infection or gastroenteritis at time of randomization or registration
* Infant consuming supplemental foods
* Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake at time of randomization or registration
* Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others) and children with known head/brain disease/injury such as Microcephaly, Macrocephaly or others

Primary outcomes:
measure: Anthropometric parameters
timeFrame: 6 months
measure: Fecal bacteria analysis
timeFrame: 6 months
Secondary outcomes:
measure: Dietary
timeFrame: 6 months
measure: Formula intake
timeFrame: 6 months
measure: All medically confirmed adverse events and antibiotic record
timeFrame: 6 months
measure: Fecal sIgA and SCFA analysis
timeFrame: 6 months
measure: Saliva cortisol, IgA, chromogranin A and lysozyme
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01903772: Effects of Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Inspiratory Muscle Weakness
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2013-07-19
Enrollment: 72
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The additional effect of inspiratory muscle training as an adjunct to a general exercise training program in patients with COPD with inspiratory muscle weakness will be studied. The main hypothesis is that inspiratory muscle training combined with an exercise training program improves functional exercise capacity more than an exercise training program without the addition of an inspiratory muscle training program.


Eligibility criteria: Inclusion Criteria:

* Patients with COPD
* Eligible to participate in an inpatient pulmonary rehabilitation program of 3 weeks
* Pi,max \<60 centimeters of water or \<50% of the predicted normal value

Exclusion Criteria:

* Major comorbidities preventing successful participation in an 8 week exercise training intervention
* use of non-invasive ventilation

Primary outcomes:
measure: 6-Minute walking distance
timeFrame: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
Secondary outcomes:
measure: exercise capacity (constant work rate test)
timeFrame: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
measure: maximal inspiratory pressure (PImax)
timeFrame: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
measure: inspiratory muscle endurance capacity
timeFrame: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
measure: dyspnea
timeFrame: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
Other outcomes:
Locations:
city: Schönau am Königssee
country: Germany
facility: Schön Klinik Berchtesgadener Land
state: Bayern
Study officials:
References: