louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04663659: The Effect of Diabetes Mellitus on Mortality of Patients With COVID-19
Official title: The Effect of Diabetes Mellitus on Mortality in Patients Hospitalized in the COVID Intensive Care Unit in the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Diabetes Mellitus
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years of age with and without a medical history of DM in their history will be identified and compared in 2 groups

Brief summary: The study includes patients over 18 years old who were hospitalized in our covid intensive care unit between March 16 and May 16, 2020.

Retrospective records were examined by examining the electronic data files of the patients.

Polymerase Chain Reaction (PCR) tests performed with nasopharyngeal swab taken from the person, which is the standard diagnostic method, and also the diagnosis of infection symptoms, risk factors and thoracic CT scans indicating pneumonia were diagnosed.

Patients over 18 years of age with and without a medical history of DM in their history were identified and compared in 2 groups.

Detailed description: The study includes patients over 18 years old who were hospitalized in our covid intensive care unit between March 16 and May 16, 2020.

Retrospective records will be examined by examining the electronic data files of the patients.

Polymerase Chain Reaction (PCR) tests performed with nasopharyngeal swab taken from the person, which is the standard diagnostic method, and also the diagnosis of infection symptoms, risk factors and thoracic CT scans indicating pneumonia were diagnosed.

Patients over 18 years of age with and without a medical history of DM in their history will be identified and compared in 2 groups.

Demographic data such as age, gender, Body Mass Index (BMI) of all patients, presence of additional comorbid disease, blood glucose values during hospitalization in intensive care, ferritin, C-Reactive Protein (CRP), respiratory support methods (nasal oxygen, nasal high flow, non-invasive mechanical ventilation, intubation), length of stay in intensive care unit, and mortality will be recorded.

Eligibility criteria: Inclusion Criteria:

* All patients over 18 years of age

Exclusion Criteria:

* Patients under 18 years of age

Primary outcomes:
measure: Mortality
timeFrame: 3 months
measure: length of stay in intensive care
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: SisliHamidiye Etfal Education and Training Hospital
Study officials:
affiliation: Sisli Hamidiye Etfal Education and Training Hospital
name: Nermin Balta Basi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00408759: Hypnosis for Treating Xerostomia Following Radiotherapy in Head & Neck Cancer Patients
Official title: Phase 2 Study of Hypnosis for Treating Xerostomia Following Radiotherapy in Head & Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Xerostomia
Keywords: xerostomia
hypnosis
dry mouth
radiotherapy
head and neck cancer
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-12-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: xerostomia develops in all patients with head and neck cancer following radiotherapy. it consists one of the main side effects which affects quality of life. currently, there is no standard of care for treating this condition. parasympathomimetic drugs may help but carry significant side effects.

hypnosis may affect autonomic function such as salivation, in healthy people.in this study we will explore the efficacy of hypnosis in improving salivation, in the patient population.

Detailed description: 10 head and neck cancer patients with xerostomia following radiotherapy will be assessed for severity of xerostomia using questionnares and quantitative salivation tests. patients responsive to citric acid will receive a hypnotic session with specific suggestion for salivation. saliva volume will be assessed pre and post hypnosis. patients will receive a CD with recorded hypnotic session to use freely at home. xerostomia will be assessed using a questionnare one week following hypnosis.

Eligibility criteria: Inclusion Criteria:

* radiotherapy for head and neck cancer
* xerostomia

Exclusion Criteria:

* psychiatric illness (present or past)

Primary outcomes:
measure: salivaa volume
measure: quality of life related to salivation
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: bnai zion MC
Study officials:
affiliation: Bnai Zion MC
name: Elad Schiff
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05645159: Blended Learning in Future Physiotherapy Professionals
Official title: Effectiveness of a Heart Disease Blended Learning Program in Future Physiotherapy Professionals: A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Teach-Back Communication
Keywords: Blended learning
Education
Teaching methods
Physiotherapy
Students
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Students of physiotherapy of the University of Valencia
Primary purpose: OTHER

Brief summary: Blended Learning (BL) is proving to be an effective method of teaching within the health professions . However, there are still scarce studies on BL conducted with undergraduate physiotherapy students. Therefore, the aim of this study was to determine the effectiveness of a heart disease BL programme in knowledge, motivation, engagement, design of the programme instructions and learning behaviours in physiotherapy students.


Eligibility criteria: Inclusion Criteria:

* studying a Physiotherapy Degree at the aforementioned University
* to be willing to participate

Exclusion Criteria:

* none

Primary outcomes:
measure: Coronary Artery Disease Education Questionnaire (CADEQ)
timeFrame: 0 weeks
measure: Coronary Artery Disease Education Questionnaire (CADEQ)
timeFrame: 4 weeks
measure: Coronary Artery Disease Education Questionnaire (CADEQ)
timeFrame: 8 weeks
measure: Coronary Artery Disease Education Questionnaire (CADEQ)
timeFrame: 12 weeks
measure: Coronary Artery Disease Education Questionnaire (CADEQ)
timeFrame: 20 weeks
Secondary outcomes:
measure: Effect of the Dader Method in Cardiovascular Risk of Patients with Risk Factors or Cardiovascular Disease Questionnaire (EMDADER)
timeFrame: 0, 4, 8, 12 and 20 weeks
measure: Academic Motivation Scale and Attributional Styles Questionnaire
timeFrame: 4, 8 weeks
measure: Student Engagement Questionnaire
timeFrame: 4, 8 weeks
measure: Community of Inquiry Survey
timeFrame: 0, 4, 8, 12 and 20 weeks
measure: Learning behaviours (I)
timeFrame: 0, 4, 8, 12 and 20 weeks
measure: Learning behaviours (II)
timeFrame: 0, 4, 8, 12 and 20 weeks
measure: Learning behaviours (III)
timeFrame: 0, 4, 8, 12 and 20 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
affiliation: University of Valencia
name: David Hernández-Guillén, PT, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00796159: Post-Marketing Surveillance Of Olmesartan Medoxomil In Combination With Hydrochlorothiazide
Official title: A Post Marketing Surveillance, Multicenter, Open-Label, Dose-Titrating, 4-Week Study Evaluating The Efficacy, Tolerability And Safety Of Olmesartan Medoxomil 20mg In Combination With 12.5mg Hydrochlorothiazide In Subjects With Stage 1 To Stage 2 Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Efficacy; Tolerability; Safety; Essential Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-24
Enrollment: 1723
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: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Filipino patients with Uncontrolled Mild to Moderate Essential Hypertension

Brief summary: This is a Post-Marketing Surveillance study evaluating the Efficacy, Tolerability and Safety of Olmesartan medoxomil 20 mg in combination with 12.5 MG of hydrochlorothiazide in subjects with mild to moderate essential hypertension

Detailed description: Non Probability Sampling

Eligibility criteria: Inclusion Criteria:

* Male and Female patients 18 to 65 y/old
* Patient previously taking low-dose medoxomil or any other ARB alone with uncontrolled BP
* Patient with uncontrolled mild to moderate hypertension (SBP\>= 140 and \<=179 mmHg OR DBP of \>=90 and \<=109 mmHg)

Exclusion Criteria:

* Pregnant of Lactating women
* History of secondary hypertension

Primary outcomes:
measure: Safety (Adverse Events)
timeFrame: 4 weeks
Secondary outcomes:
measure: Blood Pressure
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05175859: Timing of Tracheostomy in COVID-19 - Impact on Mortality
Official title: How Timing of Tracheostomy in COVID-19 Patients Changed and Its Impact on Mortality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tracheostomy
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with underlying sheer COVID-19 disease and need for endotracheal airway management. Who required a tracheostomy due to the prolonged ventilation and ventilatory weaning required.

Brief summary: How timing of tracheostomy in COVID-19 patients changed and its impact on mortality in patients with severe COVID-19 ARDS


Eligibility criteria: Inclusion Criteria:

- Severe COVID-19 infection requiring endotracheal intubation and prolonged invasive ventilation as part of the treatment of severe to moderate acute respiratory distress syndrome.

Exclusion Criteria:

* COVID-19 disease, without the need for endotracheal ventilation.
* COVID-19 disease with need for endotracheal intubation with anticipated short-term invasive ventilation.

Primary outcomes:
measure: Mortality
timeFrame: During intensive care treatment (Usually within 8 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt Niederrad
country: Germany
facility: University Hospital Frankfurt
state: Hessen
Study officials:
References:
Clinical trial NCT00010959: Single-Dose Study of Black Cohosh and Red Clover
Official title: A Phase I Single-Dose Pharmacokinetic Study of Black Cohosh and Red Clover in Healthy Menopausal Women 45-59 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Menopause
Keywords: menopause
hot flashes
botanicals
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
name: Office of Dietary Supplements (ODS)
First posted: 2001-02-05
Enrollment: 30
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This Phase I study will assess the pharmacokinetics of two botanicals, Trifolium pratense (red clover) and Cimicifuga racemosa (black cohosh). Participants will receive a single dose of one botanical preparation. The observation period will be one week. Drug toxicity, absorption, distribution, metabolism and elimination data will be collected, and dosages to be utilized in a Phase II clinical trial will be determined.

Detailed description: This Phase I study will assess the pharmacokinetics of two botanicals, Trifolium pratense (red clover) and Cimicifuga racemosa (black cohosh). Participants will receive a single dose of one botanical preparation. The observation period will be one week. Drug toxicity, absorption, distribution, metabolism and elimination data will be collected, and dosages to be utilized in a Phase II clinical trial will be determined. The Phase II trial will examine the efficacies of red clover and black cohosh for the reduction of menopausal symptoms in healthy menopausal women. The study will be randomized, double-blinded, and placebo-controlled. Study duration will be one year.

Eligibility criteria: Inclusion Criteria:

* Healthy menopausal women
* Average body weight
* Able to give informed consent

Exclusion Criteria:

* Smoker
* Use of any prescription medicine within the last 2 months
* Obesity \> 30% above ideal body weight
* Previous history of breast or reproductive cancer
* Alcohol abuse or consumption above 5 glasses of wine per week or equivalent
* Chronic disease such as diabetes or hypertension
* Concurrent non-dietary phytoestrogens or hormone use; Vegans (vegetarians who tend to consume greater than average dose of phytoestrogens)
* Concurrent participation in other clinical trial(s)
* Unavailable for followup

Primary outcomes:
measure: safety
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Illinois at Chicago
name: Suzanne Banuvar, MHSA, CCRC
role: STUDY_DIRECTOR
References:
Clinical trial NCT00735059: Test of the Nipro ELISIO H Dialyzer in Different Dialysis Treatment Procedures
Official title: Test of the Nipro ELISIO H Dialyzer in Different Dialysis Treatment Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: dialysis membrane
Polynephron
Elisio H
Polyethersulfone
Diapes
PES-DS
online post-dilution hemodiafiltration
hemodialysis
protein-bound toxins
beta-2-microglobulin
hemodialysis patients
Lead sponsor: EXcorLab GmbH
Sponsor class: OTHER
Collaborators: name: Nipro Europe N.V.
First posted: 2008-08-14
Enrollment: 14
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: A current trend in dialysis membrane engineering is to maximize the permeability for larger low-molecular weight proteins while retaining albumin. Protein-leaking dialysis membranes do not meet these requirements. Particularly in convective procedures, such as hemodiafiltration, their albumin leakage is too high \[10\]. POLYNEPHRON™, the membrane which is built in to the new Nipro ELISIO® dialyzer, is a new dialysis membrane, produced by applying an innovative spinning technique. The incentive of its development was to improve the characteristics of existing dialysis membranes, i.e., realizing a steeper sieving profile for low-molecular weight proteins without significant loss of essential larger proteins at best biocompatibility properties, for a more adequate dialysis therapy. Purpose of the planned study is to demonstrate the superior performance at lower albumin loss in different dialysis procedures of the new Nipro ELISIO® dialyzer compared with a control dialyzer with regard to the removal of the whole range of uremic toxins.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* CKD stage 5 with hemodialysis or hemodiafiltration treatment for more than three months
* Hematocrit \>30 %
* Routine anticoagulation and erythropoietin regimen
* No vascular access related problems (A/V-fistula, graft or bi-flow catheter)
* No ongoing infection
* Signed informed consent form

Exclusion Criteria:

* Inclusion criteria not met
* Known HIV or active hepatitis B or C infection (positive PCR). Pregnancy
* Unstable clinical condition (e.g. cardiac or vascular instability)
* Life expectancy less than 12 months
* Known coagulation problems
* Patients participating in another study interfering with the planned study

Primary outcomes:
measure: protein-bound toxin removal
timeFrame: pre and post dialysis treatment
measure: low-molecular weight protein removal
timeFrame: pre and post dialysis treatment
measure: small solute removal
timeFrame: pre and post dialysis treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital
Study officials:
affiliation: University Hospital Ghent, Nephrology Section
name: Raymond Vanholder, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00091559: Oral SAHA (Suberoylanilide Hydroxamic Acid) in Advanced Cutaneous T-cell Lymphoma (0683-001)
Official title: Phase IIb Multicenter Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Advanced Cutaneous T-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cutaneous T-cell Lymphoma
Sezary Syndrome
Mycosis Fungoides
Keywords: CTCL
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-09-14
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study for patients diagnosed with advanced cutaneous T-cell lymphoma (stage 1B or higher) who have progressive, persistent, or recurrent disease on or following 2 other therapies, one of which must have contained Targretin (bexarotene)or for patients who are not candidates or could not tolerate Targretin therapy.


Eligibility criteria: Inclusion Criteria:

* Patients with Cutaneous T-cell Lymphoma (Stage 1B or higher)
* Age: over 18 years of age
* Have the ability to swallow capsules.
* You must be at least 3 weeks from any prior chemotherapy or anticancer therapy treatment and have recovered from any side effects of that treatment.
* Patients also require adequate heart, liver, and kidney function.

Exclusion Criteria:

* Pregnant and nursing women and those with known allergy to the study drug are excluded from this study.
* Patients are excluded if they are currently receiving chemotherapy, radiation therapy, or other investigational anti-cancer therapy.
* Patients diagnosed with HIV, active hepatitis or who require intravenous antibiotics or antifungal agents are not permitted.

Primary outcomes:
measure: Objective response rate in patients with progressive, persistent, or recurrent disease.
Secondary outcomes:
measure: Response duration, relief of pruritis, time to progression, time to objective response, safety & tolerability in this population.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Olsen EA, Kim YH, Kuzel TM, Pacheco TR, Foss FM, Parker S, Frankel SR, Chen C, Ricker JL, Arduino JM, Duvic M. Phase IIb multicenter trial of vorinostat in patients with persistent, progressive, or treatment refractory cutaneous T-cell lymphoma. J Clin Oncol. 2007 Jul 20;25(21):3109-15. doi: 10.1200/JCO.2006.10.2434. Epub 2007 Jun 18.
citation: Fantin VR, Loboda A, Paweletz CP, Hendrickson RC, Pierce JW, Roth JA, Li L, Gooden F, Korenchuk S, Hou XS, Harrington EA, Randolph S, Reilly JF, Ware CM, Kadin ME, Frankel SR, Richon VM. Constitutive activation of signal transducers and activators of transcription predicts vorinostat resistance in cutaneous T-cell lymphoma. Cancer Res. 2008 May 15;68(10):3785-94. doi: 10.1158/0008-5472.CAN-07-6091.
Clinical trial NCT01008059: Alfentanil: Simultaneous Testing Pilot
Official title: Novel Noninvasive Assessment of Cytochrome P4450 Activity: Simultaneous Testing Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evaluate Two Paradigms for Simultaneous Assessment of Hepatic and Intestinal CYP3A
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2009-11-05
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To evaluate two paradigms for simultaneous assessment of hepatic and intestinal CYP3A activity.


Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant female, 18-40 yr. old
* Good general health with no remarkable medical conditions such as liver, kidney, heart, or lung failure
* BMI between 20-33
* Provide informed consent

Exclusion Criteria:

* Known history of liver or kidney disease
* Use of prescription or non prescription medications, herbals or foods known to be metabolized by or affect CYP3A (including oral birth control medications)
* Females who are pregnant or nursing
* Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction)
* Direct physical access to and routine handling of addicting drugs in the regular course of duty (this is a routine exclusion from studies of drugs with addiction potential).
* History of bradycardia
* Respiratory rate \<10
* History of significant pulmonary disease
* History of pre-existing medical condition predisposing to respiratory depression
* Systolic blood pressure \<100 mgHg and diastolic blood pressure \<70mmHg

Primary outcomes:
measure: Area Under the Curve of Alfentanil Concentration vs. Time Extrapolated to Infinity
timeFrame: 9 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University/Barnes Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Evan D Kharasch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: