louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04612387: Online Wellness Intervention in Medical Students
Official title: Assessing the Effectiveness of a 12-week Online Wellness Intervention in Medical Students: a Pre-Post Single-arm Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Mind Body Therapy
Wellbeing
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 65
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: Medical students are at high risk of stress. This project will test how well a 12-week stress reduction program works to reduce stress, anxiety and depression and improve well-being. The program is delivered online and each week is made of an introduction video, 7-8 minutes of yoga, 5-7 minutes of meditation and nutrition tips. At the beginning and the end of the 12-week research study, we will be using surveys to ask students about their stress, anxiety, depression, sense of control over their own life, quality of life, and pain levels. After the program, the research team will conduct interviews with the medical student to allow them to share their other feedback about the program. The researchers will also send surveys to the medical students one month after the program ends to asses their continued satisfaction with and adherence to the program.


Eligibility criteria: Inclusion Criteria:

- Medical students in any year of medical school

Exclusion Criteria:

* Hospital Anxiety and Depression Scale (HADS) Depression score \>10
* Active psychosis
* Post-traumatic stress disorder or frequent suicidal ideation
* Major medical co-morbidity
* Inability to provide written informed consent

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 12 weeks
measure: Psychological Wellbeing Scale
timeFrame: 12 weeks
measure: Five Facet Mindfulness Questionnaire
timeFrame: 12 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
References:
Clinical trial NCT03649087: Vitrification for Ovarian Tissue Harvesting
Official title: Testing of Vitrification Protocols for Ovarian Tissue Harvesting in Female to Male Transsexuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovary; Anomaly
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Vitrification of ovarian tissue
Primary purpose: BASIC_SCIENCE

Brief summary: Increasing interest has emerged concerning ovarian tissue cryopreservation and subsequent transplantation as a potential way of preserving fertility in cancer patients as well as for women who just wish to delay childbearing. As the majority of existing protocols use the slow freezing method, this study aims to test vitrification techniques of ovarian cortex.


Eligibility criteria: Inclusion Criteria:

* female-to-male transsexuals
* gender completing operation
* signed informed consent form
* willingness to donate ovarian tissue for research purposes
* age \>=18 years

Exclusion Criteria:

* malignant disease
* age under 18 years
* refusal to donate ovarian tissue

Primary outcomes:
measure: survival of ovarian tissue
timeFrame: 2 days until 2 years after freezing
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University Clinic of Obstetrics and Gynaecology of the Medical University of Vienna
Study officials:
References:
citation: Marschalek J, Egarter C, Nouri K, Dekan S, Ott J, Frank M, Pietrowski D. The effect of different vitrification protocols on cell survival in human ovarian tissue: a pilot study. J Ovarian Res. 2021 Dec 6;14(1):170. doi: 10.1186/s13048-021-00924-8.
citation: Marschalek J, Pietrowski D, Dekan S, Marschalek ML, Brandstetter M, Ott J. Markers of vitality in ovaries of transmen after long-term androgen treatment: a prospective cohort study. Mol Med. 2020 Sep 5;26(1):83. doi: 10.1186/s10020-020-00214-x.
Clinical trial NCT00434187: Study to Evaluate Multiple Doses of ERB-041 in Healthy, Female Japanese Subjects
Official title: An Ascending Multiple Dose Study of the Safety, Tolerability and Pharmacokinetics of ERB-041 Administered Orally to Healthy, Female Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-02-13
Enrollment: 24
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective is evaluate the safety, tolerability, and pharmacokinetics of multiple doses of ERB-041, an investigational drug, in healthy, female Japanese subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy as determined by the investigator on the basis of medical history and screening evaluations.

Primary outcomes:
measure: safety, pharmacokinetics
Secondary outcomes:
Other outcomes:
Locations:
city: Kan-nondai, Tsukuba-shi
country: Japan
state: Ibaraki
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02857387: Markers of Vascular Aging and Coronary Syndrome
Official title: Markers of Vascular Aging and Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Atherosclerosis and aging are associated to the raise of biochemical alterations of proteins grouped under the name of " non-enzymatic post-translational modifications ". They often correspond to the irreversible binding of glucose or other oses (glycation) or urea derivatives (carbamylation) on proteins and lead to the formation of complex compounds (post-translational modifications derived products, PTMD) that can accumulate in tissues and be responsible for deleterious effects. The specific role of these compounds in the pathophysiology of aging and atherosclerosis remains unknown, as are the molecular and cellular mechanisms implicated.

This project is based on the hypothesis that non-enzymatic post-translational modifications may cause changes in the genesis of complication of coronary atherosclerosis and that PTMD could therefore constitute relevant biomarkers in this specific clinical situation.

To explore these potential new biomarkers, the investigators designed a study in patients having experienced an acute coronary syndrome and followed during a year. The concentrations of PTMD assayed at 0, 1, 3, 12 months, will be correlated to clinical (severity and evolution) and paraclinical (cutaneous autofluorescence) data and the effect of cardiac rehabilitation will be assessed.

This should help to identify new (and non-traditional) biomarkers of coronary heart disease and determine some of the implicated pathophysiological mechanisms.


Eligibility criteria: Inclusion Criteria:

* acute coronary heart syndrome
* included during hospitalization, usual cardiologic follow-up planned in Reims university hospital

Exclusion Criteria:

* \<18yo

Primary outcomes:
measure: Post-translational modifications of Proteins quantification assessed by Liquid chromatography-mass spectrometry
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: France
country: France
facility: Chu Reims
state: Reims
Study officials:
References:
Clinical trial NCT04339387: COVID-19 Risk Stratification
Official title: COVID-19 Risk Stratification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus
Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 1326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes every adult patient noted positive for severe acute respiratory syndrome coronavirus 2 in the entire Partners HealthCare system, a consortium hospitals and health care entities located in Massachusetts that cares for over 1.5 million patients each year.

Brief summary: The investigators seek to derive and validate a clinically useful risk score for patients with Coronavirus Disease 2019 to aide clinicians in the safe discharge of patients.

Detailed description: The investigators a-priori plan the following analysis:

1. Derivation and Retrospective Validation.

   * Select all adult patients with a positive reverse transcription polymerase chain reaction for severe acute respiratory syndrome coronavirus 2 beginning March 1, 2020 until approximately 1000 patients are included.
   * Use 75% of this cohort to develop a simple risk-score that prognosticates a patient's suitability for discharge (no supplemental oxygen, no intensive care unit, and no death). Use multivariable logistic regression with forward selection informed by clinical judgement to choose variables a priori that emphasizes readily available data and easy calculation for use at the point of care.
   * Use 25% of this cohort to retrospectively validate the risk-score.
2. Prospective Validation.

   * Select all adult patients with a positive reverse transcription polymerase chain reaction for severe acute respiratory syndrome coronavirus 2 as soon as the derivation cohort in step 1 is assembled. Include approximately 250 patients.
   * Use this sample to prospectively validate the risk-score developed in part 1.

Eligibility criteria: Inclusion Criteria:

* Positive reverse transcription polymerase chain reaction for severe acute respiratory syndrome coronavirus 2
* Age 18 and older

Exclusion Criteria:

* None

Primary outcomes:
measure: Suitable for discharge
timeFrame: Duration of participation in cohort, expected to be between 1 day and 20 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT03261687: The Effects of a Water Based Exercise Programme and a Land Based Exercise Programme on Women Experiencing Pregnancy Related Pelvic Girdle Pain
Official title: The Effects of a Water Based Exercise Programme and a Land Based Exercise Programme on Women Experiencing Pregnancy Related Pelvic Girdle Pain : a Randomised Controlled Feasibility Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Pelvic Girdle Pain
Keywords: pregnancy
pelvic girdle pain
hydrotherapy
quality of life
physical therapy
Lead sponsor: University of Bradford
Sponsor class: OTHER
Collaborators: name: St George's University Hospitals NHS Foundation Trust
First posted: 2017-08-25
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a randomised controlled feasibility study
Primary purpose: TREATMENT

Brief summary: This study aimed to address whether a water exercise programme improves pain and quality of life in pregnant patients with Pelvic Girdle Pain (PGP) compared to a land-based exercise programme and the feasibility of undertaking a large-scale research programme.

Detailed description: This study aimed to address whether a water exercise programme improves pain and quality of life in pregnant patients with Pelvic Girdle Pain (PGP) compared to a land-based exercise programme and the feasibility of undertaking a large-scale research programme. Twenty-three participants with diagnosed PGP, recruited at St George's Hospital London, were randomised into two groups (water or land exercise). Each group received, four, once-weekly exercise sessions on land or water. Exercise effects on PGP were measured using a variety of outcome measures. Outcomes were assessed at baseline and post four weeks exercise.

Eligibility criteria: Inclusion Criteria:

Participants were over eighteen years old, over twelve weeks pregnant and able to speak English.

Exclusion Criteria:

Participants were excluded from the study if they had uncontrolled blood pressure, placenta praevia, pre-eclampsia, obstetric cholestatsis, uncontrolled asthma, unstable respiratory or cardiac conditions, had open skin wounds or MRSA

Primary outcomes:
measure: Pelvic Girdle Pain Questionnaire (PGPQ)
timeFrame: 4 weeks (pre and post intervention)
Secondary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 4 weeks (pre and post intervention)
measure: Patient Specific Functional Score (PSFS)
timeFrame: 4 weeks (pre and post intervention)
measure: Active Straight Leg Raise (ASLR).
timeFrame: 4 weeks (pre and post intervention)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St George's Hospital,
Study officials:
References:
Clinical trial NCT00231387: Rosiglitazone And Plaque Study for Type 2 Diabetes Mellitus
Official title: Rosiglitazone and Plaque Study: A 12 Month Randomised, Double-blind, Placebo-controlled, Magnetic Resonance Imaging Study to Evaluate the Effect of Rosiglitazone on the Structure and Composition of Carotid Atherosclerotic Plaques in Subjects With Type 2 Diabetes Mellitus and Coexisting Vascular Disease or Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-insulin-dependent Diabetes Mellitus
Keywords: diabetes rosiglitazone plaque
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-10-04
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase IIIb, randomised, double blind, placebo controlled, study in patients with type 2 diabetes mellitus and coexisting vascular disease or hypertension. The total duration of the study will be approximately 60 weeks. The aim of this study is to examine the potential beneficial effects of rosiglitazone on carotid atheroma in patients with type 2 diabetes mellitus and coexisting vascular disease or hypertension. It is hypothesised that treatment with rosiglitazone will lead to an decrease in plaque size. In addition, it is hoped that rosiglitazone will have a positive effect on plaque composition and stability.


Eligibility criteria: Inclusion criteria:

* Type 2 diabetes.
* Co-existing vascular disease.
* At least 6 months of statin or fibrate therapy.
* HbA1c \<10% at screening and with at least one atheromatous plaque causing 10-95% narrowing of the internal carotid artery.

Exclusion criteria:

* Patients with \>2 concomitant oral anti-hyperglycaemic agents within 3 months of screening.
* Previous exposure to a thiazolidinedione.
* History of chronic insulin use.
* Use of investigational drug within 30 days.
* Systolic blood pressure (bp) \> 170 mmHg or diastolic bp \>100 mmHg.
* Severe or unstable angina.
* History of: gangrene, TIA, stroke, hepatic disease, alcohol or drug abuse, surgery of the carotid arteries or claustrophobia.

Primary outcomes:
measure: The effect of 52 wks oral treatment with rosiglitazone in comparison to placebo on change from baseline of the plaque total wall volume in the carotid artery, in patients with type 2 dm and vascular disease/hypertension, using cardiac mri.
timeFrame: 52 Weeks
Secondary outcomes:
measure: These include magnetic resonance endpoints related to plaque lipid content, volume, plaque size and fibrous cap thickness. Colour duplex measurements, laboratory assays for glycaemia and lipids.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: GSK Clinical Trials Call Center
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04122287: Helicobacter Pylori First-line Treatment in Patients Allergic to Penicillin
Official title: Helicobacter Pylori First-line Treatment Containing Tetracycline in Patients Allergic to Penicillin:a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Allergic
Penicillin
Helicobacter pylori
Eradication
Tetracycline
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess and compare the effectiveness of levofloxacin-tetracycline -containing and tinidazole-tetracycline-containing quadruple regimens for the primary treatment of Helicobacter pylori infection in patients allergic to penicillin.

Detailed description: Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathologies.However,Helicobacter pylori eradication is a challenge in patients allergic to penicillin.

Therefore, the investigators aim to assess and compare the effectiveness of levofloxacin-tetracycline -containing and tinidazole-tetracycline-containing quadruple regimens for the primary treatment of Helicobacter pylori infection in patients allergic to penicillin.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-70 with H. pylori infection.
* Patients Allergic to Penicillin.

Exclusion Criteria:

* Patients with previous H. pylori eradication therapy.
* Patients treated with Histamine-receptor antagonist, proton pump inhibitor, bismuth and antibiotics in the previous 4 weeks.
* Patients with gastrectomy, acute gastrointestinal bleeding and advanced gastric cancer.
* Patients with known or suspected allergy to study medications.
* Currently pregnant or lactating.
* Inability to provide informed consent

Primary outcomes:
measure: Eradication rates in 2 groups
timeFrame: 24 months
Secondary outcomes:
measure: The rate of improving dyspepsia symptoms after Helicobacter pylori eradication
timeFrame: 24 months
measure: The rate of adverse events happening
timeFrame: 24 months
measure: The rate of good compliance
timeFrame: 24 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hospital
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01353287: Transcatheter Aortic Valve Intervention-Live Transmission
Official title: Transcatheter Aortic Valve Intervention-Live Transmission (VERITAS)Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Disorder
Keywords: Transcatheter Aortic Valve Intervention (TAVI)
Live case transmission
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: Food and Drug Administration (FDA)
First posted: 2011-05-13
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, male or female, over 18 years of age who have either undergone live case or video-taped transmission of TAVI procedure (Case), or have undergone the procedure without procedure transmission(Control).

Brief summary: The primary objective of this clinical trial is to evaluate safety of patients who underwent Transcatheter Aortic Valve Intervention (TAVI) during a live case or video-taped transmission as compared to those without procedure transmission.

Detailed description: A series of sites from outside the US, where the Edwards-Sapien and CoreValve devices are approved for commercial sale and implantation, will be recruited to retrospectively identify and extract in-hospital data of a patient who underwent TAVI during a live or video-taped procedure and a matched patient who underwent TAVI without transmission of the procedure.

Eligibility criteria: Cases Inclusion Criteria:

* Subjects \> 18 years of age, male or female
* Subject had live case or video-taped transmission of TAVI procedure with:

Edwards-Sapien transfemoral approach, Edwards-Sapien transapical approach, or CoreValve transfemoral approach

Controls Inclusion Criteria:

* Subjects \> 18 years of age, male or female
* Subject underwent TAVI without procedure transmission and had:

Edwards-Sapien transfemoral approach, Edwards-Sapien transapical approach, or CoreValve transfemoral approach

* Subjects will be matched to Cases upon the following:
* STS SCORE +/- 2points
* Date of TAVI procedure +/- 4weeks
* The first attending for the TAVI procedure
* Access site for TAVI

Primary outcomes:
measure: Major complication defined as in hospital death, stroke, tamponade, valve embolization, coronary obstruction, renal failure requiring dialysis, and the need for a pacemaker.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Vancouver
country: Canada
facility: Saint Paul's Hospital
state: British Columbia
city: Frankfurt
country: Germany
facility: CardioVasculares Centrum Frankfurt
city: Milan
country: Italy
facility: San Raffaele Hospital
city: Bern
country: Switzerland
facility: Bern University Hospital
city: London
country: United Kingdom
facility: Guys and St Thomas' Hospital
Study officials:
affiliation: Washington Hospital Center, Washington, DC
name: Ron Waksman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03775187: Expanded Access to Burosumab
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: X-linked Hypophosphatemia
Tumor-Induced Osteomalacia
Keywords: Expanded Access
Compassionate Use
XLH
TIO
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-12-13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Individual patient expanded access requests may be considered for patients who have no other treatment options

Detailed description: Expanded access may be available outside of the US in countries prior to approval by the local regulatory agencies. For full details, please visit the links provided below.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: