louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00637026: Ph II Early BC Pre-Surgical Biologic Study
Official title: A PreSurgical Study to Evaluate Molecular Alterations That Occur in Human Breast Cancer Tissue and Normal Skin After Short Term Exposure to ZD1839 (IRESSA) and to Correlate These Alterations With Pharmacokinetic Parameters.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Iressa, Gefitinib, Breast Cancer, Surgery
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Cancer International Research Group (CIRG)
First posted: 2008-03-17
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A pre-surgery study to assess changes that occur in human breast cancer material and normal skin after a short course of treatment with Iressa.


Eligibility criteria: Inclusion Criteria:

* Invasive breast cancer, Aged 18 years or older, Not more than 28 days from initial diagnosis

Exclusion Criteria:

* Pregnant or lactating patients, Prior or current radiotherapy for breast cancer, Known allergy reaction to Iressa

Primary outcomes:
measure: Molecular alterations occuring in breast cancer tissue following Iressa treatment
timeFrame: At time of diagnosis and time of patient surgery
Secondary outcomes:
measure: Molecular alterations occurring in normal skin tissue following Iressa treatment
timeFrame: At time of diagnosis and time of patient surgery
measure: To correlate molecular changes with pharmacokinetic parameters
timeFrame: At time of diagnosis and time of patient surgery
measure: To evaluate tolerability of short term Iressa treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00850226: Comparing Acceptance and Commitment Therapy (ACT) and Cognitive Therapy (CT) for Test Anxiety
Official title: Comparing Acceptance and Commitment Therapy Strategies to Cognitive Therapy Strategies in Reduction of Test Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: test anxiety
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2009-02-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study proposes to compare the effectiveness of an acceptance-based intervention and a cognitive control-based intervention for coping with test anxiety in nursing students during the HESI (Health Education Systems, Inc.) examination.

Subjects will be randomized to receive either the CT or the ACT condition. In both conditions, subjects will receive an education on test anxiety to inform them about what test anxiety is and why it occurs. Then, the different conditions will receive the respective treatment of either CT or ACT. The study is considered minimum risk because the nursing students will only be exposed to an amount of anxiety that is typical of their testing experience. Both conditions will meet three times, with each session lasting approximately one and a half hours. The purpose of the treatment is to provide subjects with tools to help them cope with their test anxiety.


Eligibility criteria: Inclusion Criteria:

* Nursing student subjects may only participate if they are currently enrolled as an undergraduate student at Drexel University.
* They must be nursing majors enrolled in Nursing 492 and intending to take the cumulative HESI examination.
* Psychology students must be enrolled in the courses where recruitment will occur.
* Pre-professional students must be currently enrolled at Drexel University, and planning to take a Standardized test within 6 months.
* All subjects must be at least 18 years of age or older.

Exclusion Criteria:

* Persons may not participate if they are unable to see/read words off of a computer screen.

Primary outcomes:
measure: grades on final exams
timeFrame: 2-3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04928326: Comparison of CorWatch With Right Heart Catheter Measurements in Heart Failure
Official title: Comparison of the InCardia Venous Pressure Diagnostic Technology CorWatch With Swan Ganz Catheter Measurements in the Cardiac Catheterization Laboratory and Cardiac Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: central venous pressure
right heart catheterization
hemodynamic congestion
Lead sponsor: InCardia Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2021-06-16
Enrollment: 43
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a diagnosis of NYHA class II-IV heart failure who meet the inclusion and exclusion criteria will be eligible for participation in this study.

Brief summary: This is an observational study to evaluate the agreement between the InCardia diagnostic technology CorWatch for the assessment of venous pressure in human subjects. This includes evaluation of InCardia technology in heart failure (HF) patients undergoing invasive right heart catheterization in a cardiac catheterization laboratory (cath lab) and in a cardiac intensive care unit (ICU).


Eligibility criteria: Inclusion Criteria:

* Diagnosed with NYHA class II-IV heart failure irrespective of ejection fraction
* Patient is able to give consent

Exclusion Criteria:

* Severe tricuspid regurgitation
* Mechanical ventilation
* Patient is pregnant
* Inability to access either of the patient's upper arms.

Primary outcomes:
measure: Agreement with right atrial pressure as measured by Swan Ganz catheter
timeFrame: During the right heart catheterization procedure
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
References:
Clinical trial NCT06649526: Comparison of Two Different Video Laryngoscopes
Official title: Comparison of Direct and Indirect Images of Two Different Video Laryngoscopes in Adult Airway Management
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anesthesia
Keywords: video laryngoscopy
airway management
intubation
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: After Ethics Committee approval and written informed consent were obtained, the study will be conducted with 70 patients aged 18-65 years and older of both sexes with American Society of Anaesthesiologists (ASA) physical status I-III. Patients will be divided into two groups by closed envelope method.

McGrath video laryngoscope (MG) will be used in patients in group MC; Modified Cormack Lehane score and POGO score in direct laryngoscopic images and Modified Cormack Lehane score and POGO score in indirect laryngoscopic images of the patients will be evaluated and recorded and then orotracheal intubation will be performed.

Hugemed videolaryngoscope (HG) will be used in patients in group H and orotracheal intubation will be performed after the Modified Cormack Lehane scores and POGO scores obtained from direct laryngoscopic and indirect laryngoscopic images of the patients are recorded.

Brief summary: The aim of this study is to answer the question of whether direct laryngoscopy can be performed with videolaryngoscopes. How do the videos of the laryngoscopes provide images directly in laryngoscopy? Primary objective: To compare the images of Hugemed and Mcgrath videolarinygoscope in direct laryngoscopy and indirect laryngoscopy secondary objective: to compare the effects on haemodynamic response Participants :people who are not expected to have difficult intubation

Detailed description: Direct and indirect images of hugemed and McGrath videolaryngoscope during intubation, haemodynamic responses, procedure time will be compared

Eligibility criteria: Inclusion Criteria:

To be between 18 -65 years old Mallampati score I-II Cormack-Lehane score I-II ASA physical status I-II who required endotracheal intubation for elective surgery

Exclusion criteria Pregnancy Mallampati score III-IV Cormack-Lehane score III-IV ASA physical score III-IV sternomental distance \< 12.5 cm mandibular-hyoid distance \< 6 cm

Primary outcomes:
measure: Comparison of Direct and Indirect Images of Two Different Video Laryngoscopes in Adult Airway Management
timeFrame: 3 months
measure: Comparison of Direct and Indirect Images of Two Different Video Laryngoscopes in Adult Airway Management
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences Kartal Dr. Lütfi Kirdar City Hospital Cevizli D-100 Güney Yanyol, No:47 Kartal Istanbul Turkey
Study officials:
References:
Clinical trial NCT00451126: Moderating Impact of Various Emotion Personality Factors on Salivary Cortisol Response to a TSST
Official title: Moderating Impact of Various Emotion Personality Factors on Salivary Cortisol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychological Stress
Keywords: emotion
personality
social stress
appraisal
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Fonds National de la Recherche Scientifique
First posted: 2007-03-23
Enrollment: 58
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: NATURAL_HISTORY
Time perspective: OTHER

Brief summary: With the aim of evaluating the putative impacts of emotion related personality factors on physical and mental disease and the mechanisms of these impacts, 58 students were submitted to a social stress test (Trier Social Stress Test) and salivary cortisol samples were taken. The subjects were also submitted to several personality trait inventory, that evaluated respectively Alexithymia, Emotional Intelligence, Resilience and the Five Factor Model of Personality.

The moderating impact of these factors on the cortisol response were analysed


Eligibility criteria: Inclusion Criteria:

* Students

Exclusion Criteria:

* Female,
* Smokers,
* Medication or alcohol abuse

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Louvain la Neuve
country: Belgium
facility: Faculté de Psychologie, Université Catholique de Louvain
Study officials:
affiliation: Fonds National de la Recherche Scientifique
name: Luminet Olivier, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02428426: Mucosal Microbiome in Human Gastric Intestinal Metaplasia and Duodenal Tissue.
Official title: Mucosal Microbiome in Human Gastric Intestinal Metaplasia and Duodenal Tissue.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mucosal Microbiome
Gastric Intestinal Metaplasia
Duodenum
Keywords: Mucosal Microbiome
gastric intestinal metaplasia
duodenum
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2015-04-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective patients scheduled for pCLE examination at Qilu Hospital, Shandong University

Brief summary: To investigate the mucosal microbiome in human gastric intestinal etaplasia and duodenal tissue.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for gastroendoscopy examination Aged between 18 and 80 years old

Exclusion Criteria:

* Antibiotic, probiotic or prebiotic usage within 2months,gastric inhibitor usage within 1 month Esophageal, gastric or duodenal cancer or other malignancy History of upper GI tract surgery Coagulopathy or bleeding disorders Allergy to fluorescein sodium Pregnant or breast-feeding (for females) Impaired renal function

Primary outcomes:
measure: The operational taxonomy units in gastric Intestinal Metaplasia and and Duodenal mucosal microbiome
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: li yanqing, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03851926: Hypofractionated Radiotherapy for Prostate Cancer
Official title: Hypofractionated Radiotherapy for Prostate Cancer in 20 Sessions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: HYPOFRACTIONED
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with prostate cancer

Brief summary: Radiotherapy is a standard definitive treatment for men with localized prostate cancer.

Recent improvements in technology allow high doses of radiation to be delivered to the prostate in less days with lower doses to surrounding healthy tissues, trying to reduce side effects.

This study is being proposed to evaluate the use of moderate hypofractionated volumetric radiotherapy in localized prostate cancer patients and assessing treatment -related later adverse events using the CTCAE 4.0

Detailed description: Recent evidence suggests that the same or better outcomes might be achieved in prostate cancer by ussing a higher dose of radiation per fraction ( 3Gy) with the consequent decrease in total days Quality of life outcomes as well as gastrointestinal and genitourinary late toxicities will be analyzed.

It is thought that this regimen will produce comparable findings and would result in substantial health care cost savings, as well as, be more convenient for patients.

Eligibility criteria: Inclusion Criteria:

* Histologic confirmation of adenocarcinoma of the prostate by biopsy
* Performance Status 0-2
* Signed informed consent form

Exclusion Criteria:

* Positive lymph-nodes or metastatic disease from prostate cancer on imaging studies
* Anticoagulant treatment, individual assessment of antiplatelet therapy
* Previous pelvic radiotherapy
* Previous surgery for prostate cancer
* Previous transurethral resection of the prostate
* History of Crohn's Disease or Ulcerative Colitis
* Antecedents of rectal fistulas in the last 10 years
* Previous significant urinary obstructive symptoms
* Previous chemotherapeutic treatments
* Non-compliance with constraints established in this protocol (see special section

Primary outcomes:
measure: Treatment-related adverse events assessed by CTCAE v4.0
timeFrame: Participants should be followed continuously, for the duration of 10 years
Secondary outcomes:
measure: Biochemical relapse free survival
timeFrame: Participants should be followed continuously, for the duration of 10 years
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Hospital de Terrassa
state: Barcelona
Study officials:
affiliation: Consorci Sanitari de Terrassa
name: NICOLAS FELTES
role: STUDY_DIRECTOR
References:
Clinical trial NCT05383326: Longitudinal Analysis of the Vaginal Microbiome
Official title: Longitudinal Analysis of the Vaginal Microbiome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Microbiome
Keywords: vaginal pH
vaginal microbiome
menstrual cycle
Lead sponsor: Viome
Sponsor class: INDUSTRY
First posted: 2022-05-20
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At least 10 women with regular menstrual cycles age 18 or older that meet the inclusion criteria.

Brief summary: This is a longitudinal, observational study with the goal of understanding vaginal microbiome changes both within a single day and across a menstrual cycle. The study will be composed of at least 10 women that have regular menstrual cycles and are 18 years of age or older. This study is direct to participant and will NOT utilize clinical sites.

Detailed description: Eligible women will be recruited into the study. They will be consented and asked to complete a health questionnaire. On six separate days during two menstrual cycles, they will be asked to collect vaginal swab samples (total of 12). For each sample collection, they will answer the sample collection questionnaire. Samples will be returned to Viome labs for analysis.

Eligibility criteria: Inclusion Criteria:

* Biological sex is female
* Willing to collect own vaginal samples
* Willing to answer health questions
* Experience menstrual cycles regularly (a monthly cycle)

Exclusion Criteria:

* Pregnant
* Antibiotic use in the past 3 months

Primary outcomes:
measure: Identification of vaginal microbial taxonomy
timeFrame: 1 year
measure: Identification of vaginal microbial functions
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bothell
country: United States
facility: Viome Life Sciences
state: Washington
Study officials:
affiliation: Viome
name: Momchilo Vuyisich
role: PRINCIPAL_INVESTIGATOR
affiliation: Viome
name: Guruduth Banavar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03138226: Living Donor Uterus Transplantation Between Identical Twins
Official title: Living Donor Uterus Transplantation Between Identical Twins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Absolute Uterine Factor Infertility
Cervical Cancer
Keywords: uterus, transplantation, infertility, twin
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital Tuebingen
name: University of Belgrade
First posted: 2017-05-03
Enrollment: 1
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: absolute uterine factor infertility - monozygotic twin

Brief summary: Living donor uterus transplantation between identical twins, with IVF before and ET several months after transplantation. The donor should have completed childbirth.

Detailed description: Living donor uterus transplantation between identical twins, with IVF before and ET several months after transplantation. The donor should have completed childbirth.

Eligibility criteria: Inclusion Criteria:

* age below 40 years
* absolute uterine factor infertility
* BMI\<30-

Exclusion Criteria:

* systemic disease

Primary outcomes:
measure: Live births after uterus transplantation
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
References:
Clinical trial NCT02834026: Impact of the Cycle Ergometer in Muscle Strength and Pulmonary Function in Patients in Hemodialysis
Official title: Impact of the Cycle Ergometer in Muscle Strength and Pulmonary Function in Patients in Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Renal Disease
Renal Dialysis
Keywords: Muscle Strength
Muscle Strength Dynamometer
Chronic Renal Disease
Exercise
Physical therapy modalities
Lead sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Muscle strength can be measured by dynamometry, but the investigators did not find in the literature the study of this technique in the quadriceps of patients with chronic kidney disease on hemodialysis. Analyze training impact conducted by cycle ergometer in quadriceps muscle strength in patients with chronic kidney disease during hemodialysis. This study will be a prospective, randomized. Inclusion of 46 patients followed by the dialysis unit of a university hospital, over 18 years, of both genders who underwent hemodialysis for more than six months and signed the consent form and enlightened. Patients will be divided into two groups: Intervention (n = 23) and control (n = 23). All will be evaluated for demographics and quadriceps strength given by standardization of technique, with hard and windy belt. The control group will be reassessed after two months of the initial assessment, since the intervention group held two months of training in hemodialysis a physical therapy protocol with the cycle ergometer.


Eligibility criteria: Inclusion Criteria:

* Patients aged over 18 years
* Performing HD over six months
* Clinically stable
* Patients no diagnosis of lung disease
* Neurological or mioarticular previous or current and agreed to participate in the study and signed informed consent and informed

Exclusion Criteria:

* Patients undergoing elective surgery or emergency six months before or during the performance of the protocol
* Cardiac decompensation
* Used continuous or nocturnal oxygen
* Patients using bracing of the lower limbs.

Primary outcomes:
measure: Muscle strength evaluated by dynamometry
timeFrame: Two months
measure: Peripheral blood tests
timeFrame: Two months
measure: Peripheral blood tests
timeFrame: Two months
measure: Peripheral blood tests
timeFrame: Two months
measure: Peripheral blood tests
timeFrame: Two months
measure: Peripheral blood tests
timeFrame: Two months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Vera Lúcia dos Santos Alves
state: SP
Study officials:
References:
citation: Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.