louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01518387: Open Study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients
Official title: Phase III Open Study of BAY 77 1931 (Lanthanum Carbonate) in Patients With Hyperphosphatemia Undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperphosphatemia
Keywords: Hyperphosphatemia in ESRD (End Stage Renal Disease) patients on dialysis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-01-26
Enrollment: 43
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
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 effect on reduction of serum phosphate and the safety of BAY77-1931 (lanthanum carbonate) in patients with hyperphosphatemia undergoing continuous ambulatory peritoneal dialysis.


Eligibility criteria: Inclusion Criteria:

* Serum phosphate levels: \>5.0 mg/dL and \<11.0 mg/dL 2 weeks after the initiation of the washout period
* Out-patient
* Undergoing CAPD for at least previous 3 consecutive months

Exclusion Criteria:

* Who may not enable to continue CAPD
* Serum phosphate levels of \>=10.0 mg/dL at the start of the washout period or \>=11.0 mg/dL 2 week after
* Corrected serum calcium level of \<7.0 mg/dL at the start of the washout period or \>=11.0 mg/dL 2 week after
* Serum intact PTH (Parathyroid) of \>=1000 pg/mL at the start of the washout period
* Pregnant woman, or lactating mother
* Significant gastrointestinal disorders including known acute peptic ulcer
* Liver dysfunction
* History of cardiovascular or cerebrovascular diseases

Primary outcomes:
measure: Change from baseline in serum phosphate levels at the end of the treatment period
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Number of participants achieving the target PSPL (Pre-dialysis serum phosphate level) and time to achievement
timeFrame: Week 8
measure: Serum calcium level corrected by serum albumin level at the end of the treatment period
timeFrame: Week 8
measure: Serum calcium x phosphate product at the end of the treatment period
timeFrame: Week 8
measure: Serum intact-PTH (Parathyroid) levels at the end of the treatment period
timeFrame: Week 8
measure: Safety variables will be summarized using descriptive statistics based on adverse events collection
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Asahikawa
country: Japan
state: Hokkaido
city: Kamakura
country: Japan
state: Kanagawa
city: Yokosuka
country: Japan
state: Kanagawa
city: Osaki
country: Japan
state: Miyagi
city: Sendai
country: Japan
state: Miyagi
city: Meguro-ku
country: Japan
state: Tokyo
city: Fukuoka
country: Japan
city: Gifu
country: Japan
city: Hiroshima
country: Japan
city: Okayama
country: Japan
city: Tokushima
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05800483: Improving Decision-Making for Low Health Literate Prostate CA Patients
Official title: Improving Decision-Making for Low Health Literate Prostate CA Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2023-04-05
Enrollment: 327
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study used a randomized controlled trial to evaluate whether Healium (designed to target preference elicitation) is as efficacious as Healing Choices (a comprehensive education and decision tool) in improving outcomes for decision-making and emotional quality of life.

Detailed description: Background: Elicitation of patients' preferences is an integral part of shared decision making, the recommended approach for prostate cancer decision making. However, existing decision aids for this population do not specifically focus on patients' preferences. Healium is a brief interactive web-based decision aid that aims to elicit patient's treatment preferences and is designed for a low health literate population. This study used a randomized controlled trial to evaluate whether Healium (designed to target preference elicitation) is as efficacious as Healing Choices (a comprehensive education and decision tool) in improving outcomes for decision-making and emotional quality of life.

Method: Patients diagnosed with localized prostate cancer who had not yet made a treatment decision were randomly assigned to the brief Healium intervention or Healing Choices, an extensive decision aid previously developed by our group that serves as a virtual information center on prostate cancer diagnosis and treatment. Assessments were completed at baseline, 6-weeks and 3-months post-baseline, and included decisional outcomes (decisional conflict, satisfaction with decision, preparation for decision-making), and emotional quality of life (anxiety/tension and depression), along with demographics, comorbidities, and health literacy.

Eligibility criteria: Inclusion Criteria:

* a diagnosis of localized prostate cancer and eligible for all treatment options (ie., surgery, radiation, active surveillance);
* had not yet made a treatment decision or begun treatment; and
* have basic proficiency (grade school level) in reading English.

Exclusion Criteria:

• none

Primary outcomes:
measure: Decisional Conflict Scale
timeFrame: 6 weeks post-baseline
measure: Decisional Conflict Scale
timeFrame: 3 months post-baseline
Secondary outcomes:
measure: Profile of Mood States- Short form
timeFrame: 6 weeks post-baseline
measure: Profile of Mood States-Short form
timeFrame: 3 months post-baseline
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05060783: Renal Cancer Detection With Liquid Biopsy
Official title: Renal Cancer Detection With Liquid Biopsy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Cancer
Oncocytoma
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Lund University
name: Elypta
First posted: 2021-09-29
Enrollment: 200
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 referred to our department by family doctors or the primary sector with a suspicion of renal tumor by CT-scanning will be asked to participate in the study. Patients with suspected small renal tumor will be offered renal tumor biopsies as standard procedure.

Brief summary: Glycosaminoglycans (GAGs) were significantly altered in localized as well advanced RCC compared to healthy samples. In addition, GAG scores correlated with progression-free survival and overall survival (OS) in a prospective cohort of patients with metastatic ccRCC and localized RCC. However, it is still unknown whether alterations in plasma and urine GAGs are exquisitely specific to RCC or are shared by other benign lesions in the kidney, such as angiomyolipomas, oncocytomas, or PEComa.


Eligibility criteria: Inclusion Criteria:

1. Patients who underwent CT-scan with suspicion of renal tumor and the scans show no sign of renal cancer.
2. For patient with ccRCC or oncocytoma, they should have a histological verified tumor (Biopsy or surgical specimen)
3. Sign up information consent
4. Can perform protocol procedure

Exclusion Criteria:

1. Non-clear cell Renal cell carcinoma
2. RCC with pure sarcomatoid differentiation, also called sarcoma of the kidney
3. Use of heparin for concurrent disease in need of blood dilution (e.g. ongoing deep vein thrombosis or lung emboli). Note: use of of heparin for thrombus prophylaxis in conjunction with primary surgery or postoperatively ≤4 weeks will be allowed.

Primary outcomes:
measure: To identify the optimal GAG score
timeFrame: 2 years
measure: To identify the optimal GAG score
timeFrame: 2 years
measure: To identify the optimal GAG score
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Zealand University Hospital
Study officials:
References:
Clinical trial NCT02416583: Concurrent Oxytocin With Membrane Sweeping Versus Dinoprostone Pessary in Labor Induction of Nulliparas at Term
Official title: Concurrent Oxytocin With Membrane Sweeping Versus Dinoprostone Pessary in Labor Induction of Nulliparas at Term
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failed Induction of Labor
Keywords: membrane sweeping
dinoprostone
nulliparas
labor induction
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-04-15
Enrollment: 140
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare concurrent oxytocin with membrane sweeping versus dinoprostone pessary in labor induction for nulliparas at term with an unfavorable cervix


Eligibility criteria: Inclusion Criteria:

* singleton pregnancy
* Nulliparous women
* gestational age \>=37.0 weeks
* Bishop score \<=6
* intact amniotic membrane
* absence of labor
* live fetus with vertex presentation
* no previous uterine surgical procedure

Exclusion Criteria:

* Multiple pregnancy
* Placenta previa

Primary outcomes:
measure: Vaginal delivery within 24 hours
timeFrame: From the time of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) until the time of vaginal delivery, assessed up to 24 hours
Secondary outcomes:
measure: Successful labor induction
timeFrame: From the time of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) until the time of active phase of labor ( defined as a cervical dilatation of >=4cm), assessed up to 24 hours
measure: Incidence of cesarean delivery
timeFrame: End of labor induction (assessed up to 120 hours)
measure: The interval from start of oxytocin to delivery
timeFrame: From the time of initiating oxytocin infusion until the time of delivery, assessed up to 120 hours
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Department of Obstetrics and Gynecology Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Hospital
name: Kyo Hoon Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05289583: Impact of Therapeutic Alliance on Dropout in a Naturalistic Sample of Patients With Borderline Pathology Receiving Residential DBT
Official title: Impact of Therapeutic Alliance on Dropout in a Naturalistic Sample of Patients With Borderline Pathology Receiving Residential DBT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Borderline Personality Disorder
Psychotherapy
Dropout
Lead sponsor: Evangelisches Krankenhaus Bielefeld gGmbH
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For this study, all patients aged from 18 to 65, discharged from our personality disorder inpatient unit between January 2019 and December 2021, and fulfilling three or more criteria for BPD as defined by DSM-IV (Borderline Personality characteristics; BPC) were considered (n = 44).

Brief summary: Participants with Borderline pathology (≥ 3 DSM-IV-criteria) receiving an inpatient Dialectical Behavior Therapy (DBT) program completed a quality assurance questionnaire set assessing demographic information and pretreatment psychopathology during the days of their inpatient stay. Beyond that, changes of therapists were documented.


Eligibility criteria: Inclusion Criteria:

* three or more criteria for BPD as defined by DSM-5 (Borderline Personality characteristics; BPC)

Exclusion Criteria:

* inability to contract and consent,
* other severe mental disorders (bipolar disorder, acute psychosis),
* current alcohol,
* illicit or not prescribed drug use,
* simultaneous participation in other treatment studies,
* pregnancy or breastfeeding,
* an inability to negotiate a non-suicide agreement,
* ongoing traumatic contact with the perpetrator, and
* a Body Mass Index \< 16.5.

Primary outcomes:
measure: Rate of Dropout
timeFrame: 8-10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bielefeld
country: Germany
facility: Research Department
Study officials:
References:
Clinical trial NCT04343183: Hyperbaric Oxygen Therapy (HBOT) as a Treatment for COVID-19 (COVID-19) Infection
Official title: Hyperbaric Oxygen Therapy (HBOT) as a Treatment for COVID-19 (COVID-19) Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: COVID-19
Keywords: covid-19
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will utilize a single-center sequential two-parallel-group (HBOT/Standard care) randomized controlled design with 2 looks to allow for early stop due to clear benefit/harm.
Primary purpose: TREATMENT

Brief summary: Patients who meet inclusion criteria will be randomized into treatment vs control group. Treatment groups will undergo Hyperbaric Oxygen Therapy (HBOT) and compared to the control group.

Detailed description: After enrollment, patients will be randomized into treatment vs control group. Both populations will receive the same inpatient medical treatment. All patients in the treatment group will undergo hyperbaric oxygen therapy under the same treatment protocol. After completion of the treatment protocol, specific study endpoints will be compared between the treatment and control groups.

Eligibility criteria: Inclusion Criteria:

* Adult inpatients \>18 years old
* Positive PCR COVID-19 testing
* CT evidence of interstitial opacity
* Oxygen saturation \<90% on room air
* pO2 = 55-70.

Exclusion Criteria:

* Increased oxygen requirements
* Hemodynamic instability (MAP\<65)
* Bradycardia (HR\<50)
* History of seizure disorder
* Pneumothorax
* GFR\<30
* Hemodialysis
* Refractory anxiety/claustrophobia
* Current pregnancy
* Uncorrectable hypoglycemia

Primary outcomes:
measure: Decrease incidence of intubation by 30% or greater
timeFrame: one month
Secondary outcomes:
measure: Decrease renal injury
timeFrame: one month
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
Study officials:
affiliation: Ochsner Health System
name: Jeffery S Kuo, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00176683: The Use of Capnography as a Guide for Oral Intubation
Official title: Assessing the Use of Capnography as a Guide for Endotracheal Intubation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Measurement
Keywords: intubation
capnography
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving general anesthesia and requiring endotracheal intubation.

Brief summary: The purpose of this study is to assess if capnography can be utilized to assist in the process of endotracheal intubation; specifically, in locating the glottic opening. Ultimately this would result in a new use of capnography to aid in securing normal and difficult airways. Currently capnography is only utilized for the confirmation of endotracheal tube placement.

If successful, this study will provide information, and allow for the development of instrumentation that will assist in difficult airway management; specifically, in locating the glottic opening when visualization may be impaired. Ultimately, this technique will be useful for routine and emergency airway management.

Detailed description: The purpose of this study is to assess if capnography can be utilized in the process of endotracheal intubation; specifically, in locating the glottic opening. Ultimately this would result in a new use of capnography to aid in securing normal and difficult airways. Currently capnography is only utilized for the confirmation of endotracheal tube placement.

If successful, this study will provide information, and allow for the development of instrumentation that will assist in difficult airway management; specifically, in locating the glottic opening when visualization may be impaired. Ultimately this technique will be useful for routine and emergency airway management.

Eligibility criteria: Inclusion Criteria:

* Patients for elective surgery, requiring general endotracheal anesthesia

Exclusion Criteria:

* Patients with a known or suspected difficult intubation
* Patients requiring specialized endotracheal tubes
* Patients with a history of tracheostomy
* Airway tumor or airway pathology

Primary outcomes:
measure: successful intubation
timeFrame: at intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: New Jersey Medical School
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Glen Atlas, MD, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06901583: Impact of a Mindfulness-Oriented Psychoeducational Program on the Mindfulness, Anger and Interpersonal Relationship Styles
Official title: Impact of a Mindfulness-Oriented Psychoeducational Program on the Mindfulness, Anger and Interpersonal Relationship Styles of Nursing Students: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurse's Role
Anger
Interpersonal Relations
Keywords: Mindfulness
Anger
Anger expression
Interpersonal relationship style
Nursing students
Randomized controlled trial
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: This study aimed to investigate the impact of a mindfulness-oriented psychoeducational program on nursing students' levels of mindfulness, anger, anger expression, and interpersonal relationship styles.

Background: Mindfulness of anger, which significantly influences interpersonal relationships, is especially crucial for the professional practice of nursing. Although numerous studies have explored anger and interpersonal relationships among nursing students, research on the impact of mindfulness interventions within this context remains limited.

Design: This study was a single-blind, randomized controlled trial with pre-test, post-test, and one-month and three-month follow-up assessments.

Methods: The study was conducted at the Faculty of Nursing, Aydın Adnan Menderes University, during the 2022-2023 academic year with first-year nursing students. A total of 84 students (Experimental: 42, Control: 42) were included in the study sample, determined through randomization. The experimental group participated in a six-week mindfulness-oriented psychoeducational program, with weekly sessions lasting 60 to 90 minutes. Data were collected using the Personal Information Form, the Mindful Attention Awareness Scale (MAAS), the Trait Anger/Anger Expression Inventory (TAXI), and the Interpersonal Style Scale (ISS).


Eligibility criteria: Inclusion Criteria:

* To have higher mean scores of "trait anger"

Exclusion Criteria:

* Completion of formal training in mindfulness, anger, and interpersonal relationships

Primary outcomes:
measure: (MAAS) Mindful Attention Awareness Scale
timeFrame: 3 months
measure: (TAXI) Trait Anger/Anger Expression Inventory
timeFrame: 3 months
measure: (ISS) Interpersonal Styles Scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Adnan Menderes University Nursing Faculty
Study officials:
References:
Clinical trial NCT01674283: Effect of Glucagon on Uterine Contractility at the Time of Embryo Transfer in in Vitro Fertilization
Official title: Effect of Glucagon on Uterine Contractility at the Time of Embryo Transfer in in Vitro Fertilization
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Women With Fertility Disorder
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
First posted: 2012-08-28
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The success of in vitro fertilization is based mainly on uterine implantation embryo. An excessive uterine contractility may interfere with implantation by a movement of the embryo in the uterus. The inhibition of the uterine contractility may have a positive effect on success rate of in vitro fertilization. It is through parenteral injection of glucagon and its spasmolytic effect on various smooth muscles and thereby on the uterine muscle, at the time of embryo transfer, the investigators intend to improve the pregnancy rates obtained after IVF.

Detailed description: Women will have a cycle of in vitro fertilization (IVF) and follow the standard protocol established by the clinic ovo or the fertility clinic of CHUM. On the day of embryo transfer, the investigators will administer 1 mg of Glucagon or placebo intramuscularly 10 minutes before the embryo transfer. The uterine contractility will be measured by ultrasound before and after injection to document the impact of Glucagon on it and we will proceed to embryo transfer.

Eligibility criteria: Inclusion Criteria:

* Women doing fertility treatment at the clinic ovo or fertility clinic of CHUM
* Less than 40 years old
* Women with stimulate in vitro fertilization cycle
* Women able to give her consent

Exclusion Criteria:

* Body mass index \> 35 kg/m2
* Women with diabetes
* Women with hypertensive disorders
* Women with a blood pressure greater or equal to 140/90 mmHg at the randomization visit
* Cons-indication to taking Glucagon:

  * Hypersensitivity to product
  * Pheochromocytoma or history of pheochromocytoma
  * Insulinoma
  * Taking a beta-blocker (drug interactions)

Primary outcomes:
measure: Uterine muscle relaxation
timeFrame: 30 minutes
Secondary outcomes:
measure: Embryo implantation and pregnancy rate
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Clinique Ovo
state: Quebec
Study officials:
affiliation: clinique ovo and CHUM
name: Eric Himaya, Dr
role: PRINCIPAL_INVESTIGATOR
References: