louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01620580: Symptom Management Program for Hemodialysis Patients
Official title: Symptom Management Program for Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Haemodialysis-induced Symptom
Keywords: sleep disturbance
tiredness
itching & numbness
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2012-06-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Self-management intervention may decrease symptom burden and improve functioning over time.

Detailed description: Self-management intervention (strategies) may decrease symptom burden (sleep disturbance, tiredness; itching and numbness) and improve functioning (social, physical and emotional) over time(baseline, 3 weeks and 8 weeks).

Eligibility criteria: Inclusion Criteria:

1. age ≥ 18 years old,
2. on HD three times a week,
3. received HD for ≥ six months,
4. read and write English,
5. have telephone service.

Exclusion Criteria:

* history of dementia,
* acquired immunodeficiency syndrome (AIDS) and active cancer, and
* inability to give informed consent.

Primary outcomes:
measure: Decrease symptom burden
timeFrame: 8 weeks
Secondary outcomes:
measure: Feasibility of implementing self management intervention
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: DaVita Summit Dialysis
state: Texas
city: Houston
country: United States
facility: DaVita Houston Dialysis
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Francess V Danquah, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dodd M, Janson S, Facione N, Faucett J, Froelicher ES, Humphreys J, Lee K, Miaskowski C, Puntillo K, Rankin S, Taylor D. Advancing the science of symptom management. J Adv Nurs. 2001 Mar;33(5):668-76. doi: 10.1046/j.1365-2648.2001.01697.x.
citation: Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
Clinical trial NCT01335880: Helping People to Exercise Regularly
Official title: Helping People to Exercise Regularly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Heart Disease
Keywords: Obesity
Heart Disease
Seniors
Elderly
Chronic Disease
Prevention
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Carnegie Mellon University
First posted: 2011-04-14
Enrollment: 117
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study tests two different incentive mechanisms to induce members of a particular urban senior center to attend more exercise classes. Coupons for future use are given to participants who attend an exercise class and will be redeemable within either a one week or three month time period, depending on which experimental group the participant is assigned to. Frequency of exercise class attendance at the end of 2 months will be the primary outcome.


Eligibility criteria: Inclusion Criteria:

* Age 55 years or older
* Member of the Philadelphia Senior Center

Exclusion Criteria:

* None

Primary outcomes:
measure: Frequency of exercise class attendance
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Carnegie Mellon University
state: Pennsylvania
Study officials:
affiliation: Carnegie Mellon University
name: Erte Xiao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00460980: Effect of Virtual Reality Training by Novices on Laparoscopic Cholecystectomy in a Porcine Model
Official title: Effect of Virtual Reality Training by Novices on Laparoscopic Cholecystectomy in a Porcine Model
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gallstones
Keywords: resident training
laparoscopic skills
surgical skills assessment
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2007-04-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This study proposes evaluation of an educational tool, a laparoscopic virtual reality simulator. The purpose of this study is to determine whether training on the LapSim Simulator transfers to improved laparoscopic cholecystectomy operative performance in an animal model.

Detailed description: This is study protocol involves the training and evaluation of general surgery interns on a laparoscopic simulator (LapSim®, Surgical Science Ltd, Göteborg, Sweden, version 3.0.

Eligibility criteria: Inclusion Criteria:

* Surgical interns (PGY 1) are eligible
* Twenty-five (25) participants will comprise this group

Exclusion Criteria:

* Prior clinical experience with laparoscopic surgery as the assistant surgeon.
* Prior simulation training (mechanical, PC-based or otherwise).

Primary outcomes:
measure: Score on Global Outcomes Assessment of Laparoscopic Skills
timeFrame: 5 weeks, 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University College of Physicians and Surgeons
state: New York
Study officials:
affiliation: Columbia University
name: Dennis L Fowler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03027180: Pressure Levels on Lung Expansion
Official title: DIFFERENT LEVELS OF NONINVASIVE POSITIVE AIRWAY PRESSURE FOR LUNG EXPANSION ON PATIENTS WITH PLEURAL DRAINAGE: A STUDY VIA COMPUTED TOMOGRAPHY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pleural Effusion
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Question: What level of noninvasive positive airway pressure is able to expand the lungs of people with pleural drainage? Design: Cross-sectional, experimental and randomized study. Participants: Four consecutive people with pleural effusion drained within 24 hours, with controlled pain and without contraindications to use of noninvasive positive pressure. Intervention: Each person will be randomly subjected to three levels of noninvasive positive airway pressure: 0 (zero), 4 and 15 cmH2O for evaluation via chest computed tomography. Outcome measures: Lung area.


Eligibility criteria: Inclusion Criteria:

* age over 18 years
* presence of pleural drainage after traumatic hemothorax
* thoracic drainage within 24 hours
* controlled pain (below 3 points in the visual numeric scale, varying from zero to ten)

Exclusion Criteria:

* contraindication for use of noninvasive positive pressure in the airways, such as reduced level of consciousness (drowsiness, agitation or confusion), use of vasoactive drugs, complex arrhythmias, upper airway obstruction or trauma in the face, esophagus or upper airway, ineffective cough, inability to swallow, distended abdomen, nausea, vomiting, upper gastrointestinal bleeding
* previous application of any sort of lung expansion technique after thoracic drainage.

Primary outcomes:
measure: Lung area
timeFrame: 20 seconds after pressure application
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Cidade de São Paulo
name: Adriana C Lunardi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02577380: Addressing Gender Based Violence in HIV Testing and Counseling
Official title: Addressing Gender Based Violence in HIV Testing and Counseling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intimate Partner Violence
Lead sponsor: Population Council
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2015-10-16
Enrollment: 500
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overarching goal of this study is to pilot an approach to HIV testing and counseling (HTC) that addresses intimate partner violence. The results of the study will fill an important gap in the literature and contribute to efforts by Kenyatta National Hospital in Nairobi, Kenya-and the HIV and sexual and reproductive health field globally-to better address intimate partner violence in our work.


Eligibility criteria: Inclusion Criteria:

* Lived in the community for at least one year
* Aged 15-49 years
* Satisfy gender requirement

Exclusion Criteria:

* Lack of informed consent

Primary outcomes:
measure: Comparison of HTC experiences
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Population Council
name: Nicole Haberland, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haberland N, Ndwiga C, McCarthy K, Pulerwitz J, Kosgei R, Mak'anyengo M, Peltz A, Wong VJ, Kalibala S. Addressing Intimate Partner Violence and Power in Intimate Relationships in HIV Testing Services in Nairobi, Kenya. AIDS Behav. 2020 Aug;24(8):2409-2420. doi: 10.1007/s10461-020-02801-9.
Clinical trial NCT04773080: Incidence, Risk Factors and Consequences of Acute Kidney Injury in Patients Undergoing Esophageal Cancer Surgery
Official title: Incidence, Risk Factors and Consequences of Acute Kidney Injury in Patients Undergoing Esophageal Cancer Surgery: a Historical Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Postoperative Complications
Lead sponsor: Azienda Ospedaliera di Padova
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients who underwent elective esophageal surgery for cancer

Brief summary: Esophagectomy serves as an exemplar of major operative trauma, with well-known risk of pulmonary, cardiac, anastomotic, and septic complications and the presence of postoperative complications after esophagectomies for cancer is associated with a reduced long-term survival. There is a paucity in the literature regarding postoperative renal outcomes after esophageal surgery, with a wide range of incidence.

The investigators will conduct a historical cohort study aiming to evaluate the incidence of postoperative acute kidney injury in patients undergoing elective esophageal cancer surgery. Secondary, the investigators will assess the progression of the acute injury and the association with adverse pulmonary, cardiac, anastomotic, and septic events, as well as increase in hospital stay and mortality. The investigators will also identify risk factors associated with acute kidney injury occurrence.


Eligibility criteria: Inclusion Criteria:

* Elective esophagectomy

Exclusion Criteria:

* End-stage renal disease
* Missing data for acute kidney injury definition
* Second surgery (for patients having multiple surgeries performed during a 30-day period, only the first in each period will be included)

Primary outcomes:
measure: Incidence of postoperative acute kidney injury
timeFrame: within 48 hours after surgery
Secondary outcomes:
measure: Incidence of transient or persistent postoperative acute kidney injury
timeFrame: 48 hours after development of acute kidney injury
measure: Number of patients with renal recovery
timeFrame: at 7 days, after 30 days and 3 months
measure: Incidence of postoperative pulmonary complications
timeFrame: within 30 days after surgery
measure: Incidence of major adverse cardiac and cerebrovascular events (MACCE)
timeFrame: within 30 days after surgery
measure: Incidence of sepsis
timeFrame: within 30 days after surgery
measure: Mortality in hospital
timeFrame: 1 year
measure: Increase in length of hospital stay
timeFrame: 1 year
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
state: Veneto
Study officials:
affiliation: Azienda Ospedaliera di Padova
name: Ilaria Godi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03001492: Does Premature Luteinization Matter?
Official title: Does Measurement of Serum Progesterone on the Day of Trigger Matter?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premature Progesterone Rise
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the women undergo controlled ovarian hyperstimulation for IVF/ICSI. only fresh cycles will be involved

Brief summary: Elevation of serum progesterone on the day of ovulation triggering in IVF/ICSI cycles is suggested to be associated with compromized outcomes. Others found that this rise didnot affect the IVF/ICSI outcomes. It is still controversal if premature luteinization would affect the IVF/ICSI outcomes.


Eligibility criteria: Inclusion Criteria:

* Planned fresh Embryo transfer

Exclusion Criteria:

* Cancelation of the embryo transfer for any reason

Primary outcomes:
measure: Clinical pregnacy rate
timeFrame: 14 days after the day of embryo transfer (ET)
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Osama Abdalmageed
state: Non-US/Non-Canadian
Study officials:
affiliation: Women health center
name: Osama Abdalmageed
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sonmezer M, Pelin Cil A, Atabekoglu C, Ozkavukcu S, Ozmen B. Does premature luteinization or early surge of LH impair cycle outcome? Report of two successful outcomes. J Assist Reprod Genet. 2009 Mar;26(2-3):159-63. doi: 10.1007/s10815-009-9299-5. Epub 2009 Feb 18.
Clinical trial NCT02948192: The Reproductive Microbiome & Perinatal Health Outcomes
Official title: The Reproductive Microbiome & Perinatal Health Outcome
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Human Microbiota
PreTerm Birth
Human Gastrointestinal Microbiota
Metabolomics
Keywords: Preterm Delivery
Preterm Birth
Vaginal Microbiome
Microbiome
Gut Microbiome
African American
Metabolomics
Pregnancy
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: Discovery Foundation
First posted: 2016-10-28
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: African american women between 18 and 45 years of age who are pregnant with a singleton and present for prenatal care at 20 weeks of gestation or less.

Brief summary: Pregnant African American women between 18 and 45 years of age will be enrolled at 20 weeks of gestation or less. Biological specimens (vaginal swabs, rectal swab) will be collected at enrollment, 23-24 weeks, at 28-29 weeks, and at the onset of labor. A urine sample will be obtained at entry and at the time of delivery for metabolomic analysis. Participants will also collect a dietary survey at entry, 23-24 weeks, and 28-29 weeks. The biological specimens will then be analyzed for their microbiomial profile. This will then be correlated with the timing of their delivery as well as other comorbidities such as obesity, hypertension, and diabetes.


Eligibility criteria: Inclusion Criteria:

* Able to read and understand English, full decision making capabilities, African American (self-identified), Pregnant, At 20 weeks or less of gestation, Singleton pregnancy, 18-45 years of age

Exclusion Criteria:

* Race other than African American, Advanced gestational age (\>20 weeks), Multiple gestations, Less than 18 years or greater than 45 years of age.

Primary outcomes:
measure: Preterm Delivery
timeFrame: 36 weeks
Secondary outcomes:
measure: Microbiome profile
timeFrame: 36 weeks
measure: Metabolomic profile
timeFrame: 36 weeks
measure: Medical comorbidities
timeFrame: 36 weeks
measure: Gut Microbiome profile
timeFrame: 36 weeks
measure: Term delivery
timeFrame: 36 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01137292: Open, Non Comparative Study Of Voriconazole In Slovak Patients With Very High Risk Of Developing An Invasive Fungal Infection
Official title: Voriconazole In High-Risk Patients With Invasive Fungal Infections In Slovakia. An Open, Prospective, Non-Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Fungal Infections
Keywords: observational study
voriconazole
high-risk patients
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-06-04
Enrollment: 177
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female patients older than 2 years with invasive fungal infections.

Brief summary: Assessment of safety and efficacy of voriconazole in real-life setting in the treatment of high risk patients with invasive fungal infections. The study is conducted in Slovakia only.


Eligibility criteria: Inclusion Criteria:

* Male or female patient of age 2 years or older.
* High-risk patients with proven, probable or possible invasive fungal infection (IFI) according to the EORTC/MSG criteria.
* Patients indicated for secondary prophylaxis of invasive aspergillosis.

Exclusion Criteria:

* Patients with known hypersensitivity to voriconazole or to any of the excipients.
* Patients with contraindicated concomitant medications according to the SmPC.
* Children less than 2 years of age.
* Pregnancy and lactation.

Primary outcomes:
measure: Number of Participants With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit
timeFrame: up to 2 weeks (EOT visit)
measure: Number of Participants With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit
timeFrame: more than 2 weeks (Test-of-Cure visit)
measure: Number of Participants With Investigator's Satisfaction With the Efficacy of Voriconazole Assessment at the EOT Visit
timeFrame: up to 2 weeks (EOT visit)
measure: Number of Participants With Investigator's Satisfaction With the Tolerability of Voriconazole Assessment at the EOT Visit
timeFrame: up to 2 weeks (EOT visit)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04174092: Catastrophism in Chronic Inflammatory Rheumatism
Official title: Catastrophism in Chronic Inflammatory Rheumatism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Inflammatory Rheumatism
Keywords: Catastrophism
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 533
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Catastrophic is defined as a negative cognitive and emotional response based on inadequate pain expression. It has three components: rumination, amplification and vulnerability. The assessment of catastrophism is carried out using a validated questionnaire called the "Pain Catatrophizing Scale" (PCS).

Recent studies highlight the significant impact of catastrophism in neuromuscular and mechanical rheumatic diseases such as gonarthrosis gonalgia and low back pain. In these diseases, it has been shown that catastrophism has a negative impact both on the experience of pain and on the response to different types of treatments (medical and surgical). Several studies have implemented multidisciplinary management and in particular cognitive-behavioural therapy with an improvement in the pain experience in patients who are catastrophic.

In chronic inflammatory rheumatic diseases such as rheumatoid arthritis, spondyloarthritis and psoriatic arthritis, the prevalence and impact of catastrophism is still poorly understood.


Eligibility criteria: Inclusion Criteria:

* Major patients, hospital follow-up, with RA according to ACR 2010 criteria, or spondyloarthritis according to ASAS 2009 criteria or according to AMOR or psoriatic arthritis according to Caspar 2006 criteria.
* Patient who has given free and informed consent.
* Patient who has signed the consent form.
* Patient affiliated or benefiting from a health insurance plan.
* Adult patient (≥18 years old).

Exclusion Criteria:

* Patient under the protection of justice, under guardianship or curatorship.
* Patient unable to express consent.
* Patient for whom it is impossible to provide informed information.
* Poor command and understanding of the French language making it impossible to complete self-questionnaires

Primary outcomes:
measure: catastrophic assessment
timeFrame: Day 0
measure: catastrophic assessment
timeFrame: at 3 months
measure: catastrophic assessment
timeFrame: at 6 months
measure: catastrophic assessment
timeFrame: at 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Anissa MEGZARI
role: STUDY_DIRECTOR
References: