louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01487304: Impact of Professional Societies' Recommendations on Practical Use of Hormone Replacement Therapy
Official title: Impact of Professional Societies Recommendations on Practical Use of Hormone Replacement Therapy - Project "WOMAN 2005"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Hormone Replacement Therapy, Post-Menopausal
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-07
Enrollment: 3760
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Post-menopausal women suffering from climacteric symptoms who could benefit a switch from standard therapy to low dose therapy at the discretion of the individual physician

Brief summary: This study is conducted in Europe. The aim of this study is to verify the therapeutic effects of low-dose hormone replacement therapy (HRT) in female patients over adequately long time period in normal clinical practice conditions in the Czech Republic.


Eligibility criteria: Inclusion Criteria:

* Post-menopausal

Primary outcomes:
measure: Breast tenderness
Secondary outcomes:
measure: Patient treatment satisfaction after switch to low dose HRT
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05696704: Telehealth to Reduce Mental Health in Family Caregivers
Official title: Utilizing Telehealth to Reduce Pre-Death Grief, Burden, and Stress in Family Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Issue
Grief
Burden, Caregiver
Lead sponsor: Texas Tech University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overarching goal of this project is to evaluate if evidence-based interventions can reduce PDG, burden, and stress in informal caregivers of individuals with dementia when provided over telehealth.

Detailed description: Aim 1: Examine the effects of two individual evidence-based therapies for informal caregivers of dementia patients over telehealth.

Eligibility criteria: Inclusion Criteria:

* Participants must be informal caregivers (e.g., spouse; child; close friend) of individuals with dementia
* Informal caregivers can be family members or close friends
* Adults (18 to 89 years old) who read, write, and speak in English
* Mental Health Diagnosis (e.g., Generalized Anxiety Disorder; Major Depressive Disorder

Exclusion Criteria:

* Formal caregivers (who are being paid to take care of the patient)
* Any informal caregivers with cognitive impairment is identified during the assessment.

Primary outcomes:
measure: Prolonged Grief Scale-12 (measuring pre-death grief)
timeFrame: [Time Frame: through study completion, an average of 6 months]
Secondary outcomes:
measure: Zarit Burden Inventory (ZBI)
timeFrame: [Time Frame: through study completion, an average of 6 months]
measure: Perceived Stress Scale
timeFrame: [Time Frame: through study completion, an average of 6 months]
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University
state: Texas
Study officials:
affiliation: jonsinge@ttu.edu
name: Jonathan D Singer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00873704: Supplemental Oxygen in Vascular Surgery
Official title: Supplemental Postoperative Oxygen and the Risk of Surgical Wound Infection in a Vascular Surgery Population: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound Infection
Vascular Surgery
Lead sponsor: North Karelia Central Hospital
Sponsor class: OTHER
First posted: 2009-04-02
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to test the hypothesis that supplemental postoperative oxygen reduces the risk of surgical wound infection in patients following lower limb vascular surgery.


Eligibility criteria: Inclusion Criteria:

* lower limb vascular surgery

Exclusion Criteria:

* COPD
* sPO2 less than 90%

Primary outcomes:
measure: surgical wound infection
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Joensuu
country: Finland
facility: North Karelia Central Hospital
city: Jyväskylä
country: Finland
facility: Central Finland Central Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Lappeenranta
country: Finland
facility: South Karelia Central Hospital
city: Mikkeli
country: Finland
facility: Central Hospital of Mikkeli
city: Rovaniemi
country: Finland
facility: Lapland Central Hospital
Study officials:
References:
citation: Turtiainen J, Saimanen EI, Partio TJ, Makinen KT, Reinikainen MT, Virkkunen JJ, Vuorio KS, Hakala T. Supplemental postoperative oxygen in the prevention of surgical wound infection after lower limb vascular surgery: a randomized controlled trial. World J Surg. 2011 Jun;35(6):1387-95. doi: 10.1007/s00268-011-1090-y.
Clinical trial NCT01513304: Chiropractic Manual Therapy in Infantile Colic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infantile Colic
Lead sponsor: Anglo-European College of Chiropractic
Sponsor class: OTHER
First posted: 2012-01-20
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Primary purpose: TREATMENT

Brief summary: Efficacy of chiropractic manual therapy in infants with excessive crying behaviour. Influence of parental bias in reporting crying behaviour.


Eligibility criteria: Inclusion Criteria:

* Excessive crying,
* infant less than 8weeks of age,
* born at gestational age 37 weeks or later, otherwise healthy

Exclusion Criteria:

* Not accepted for chiropractic care

Primary outcomes:
measure: Daily crying diary
Secondary outcomes:
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: AECC
state: Dorset
Study officials:
References:
Clinical trial NCT02255604: Effect of Intralymphatic Immunotherapy
Official title: Effect of Intralymphatic Immunotherapy at Basophil Response and Plasmacell Kinetic in Patients With Allergic Rhinitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergy
Immune Tolerance
Injection Site Discomfort
Keywords: Allergic Rhinitis
Allergen immunotherapy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2014-10-02
Enrollment: 36
Sex: ALL
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 investigators want to investigate whether specific immunotherapy can be delivered directly into a lymph node. The investigators think that a direct introduction of allergen to the antigen presenting cells in the lymph node a give a strong immune response and that this can change the number of injections needed in allergen immunotherapy. The investigators do measurements of clinical effect and a variety of paraclinical test to see if the investigators can find af biomarker of successful specific immune therapy of grass allergy.

Detailed description: Patients are injected with 3 or 4 doses of alk 225 Phleum Pratense 1000 standard quantity units/ml in a lymph node in the groin.

The investigators monitor clinical response and use of medication during the grass pollen season. SMS (Symptom and Medication Score) will be used.

The investigators count the number of immunoglobulin E grass producing plasma cells in blood one week after each injection. The investigators also do basophil activation tests, nasal provocation tests and titrated skin prick test to monitor effect.

Adverse events will be recorded.

Eligibility criteria: Inclusion Criteria:

* Allergic rhinitis to grass pollen, more than 3 mm reaction at skin prick test for grass, age between 18 and 40 years.

Exclusion Criteria:

* Uncontrolled asthma.
* Severe asthma with post bronchodilator test forced expiratory volume at 1 second less than 70% of expected.
* Severe co morbidity. Allergy to Fenol or Aluminium hydroxid.
* Any autoimmune diseases. Treatment with beta blocking medicine.
* Any heart diseases.
* Severe arterial hypertension. Kidney failure.
* Known malignancy. Known pregnancy.

Primary outcomes:
measure: Change in cSMS (Combined Symptom and Medication Score)
timeFrame: 3 years
Secondary outcomes:
measure: Change in Circulating Grass Specific Immunoglobulin E Producing Plasmacells
timeFrame: one week from vaccinations
Other outcomes:
measure: Change in Basophil Sensitivity
timeFrame: 2 years
Locations:
city: Aarhus
country: Denmark
facility: Lungemedicinsk Forskningsafdeling. Aarhus University Hospital
Study officials:
affiliation: Lungemedicinsk forskningsafdeling. Aarhus University Hospital.
name: Søren Helbo SH Skaarup, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05894304: The Effects of Scapular Muscles Training Using a Suspension System in Patients With Non Spacific Chronic Neck Pain and Scapular Dyskinesia
Official title: The Effects of Scapular Muscles Training Using a Suspension System in Patients With Non Spacific Chronic Neck Pain and Scapular Dyskinesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scapular Dyskinesis
Keywords: Scapular diskinesia
Non spacific chronic neck pain
Suspension system
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to investigate the effect of scapular muscle training using a suspension system in patients with non spacific chronic neck pain with scapular diskinesia


Eligibility criteria: Inclusion Criteria:

* Patients age between 20-35 years.
* Patients with non spacific pain(pain \> 3 month).
* pain must have been present for at least the previous 12 weeks.
* Patients with non spacific chronic neck pain with scapular dyskinesia.
* Patient BMI\<30.

Exclusion Criteria:

* History of previous neck surgery.
* Recent or old fractures.
* Cognitive impairment and inability to understand the scale.
* Systematic inflammatory disease e.g., rheumatoid arthritis and ankylosing Spondylitis.
* Neck pain with radiculopathy or neuropathy.
* Scapular dyskinesia due to other pathology such as shoulder impingement

Primary outcomes:
measure: Pain intensity
timeFrame: 1week
measure: Function
timeFrame: 1 week
measure: Scapular muscle strength
timeFrame: 1week
measure: Scapular position
timeFrame: 1week
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo university
Study officials:
References:
Clinical trial NCT04096404: Gene-based Personalised Diet and Physical Activity Advice on Adiposity Indices Personalised Diet and Physical Activity Advice on Adiposity Indices in University Students
Official title: A Longitudinal Study to Determine the Effect of Gene-based Personalised Diet and Physical Activity Advice on Adiposity Indices in University Students
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adiposity
Behavior, Health
Lead sponsor: St Mary's University College
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A longitudinal study to determine the effect of gene-based personalised diet and physical activity advice on adiposity indices in university students.

Detailed description: The study uses a randomised controlled design; data for all variables (participant characteristics, height, weight, body mass index (BMI), waist circumference (WC), body fat percentage (BF%), healthy eating motivation, dietary intake and physical activity) will be collected initially from participants at St Mary's University during September and October 2019. Participants will be genotyped, stratified randomisation (based on genotype and BMI) will be used to allocate participants to three different groups (1. Control: no advice, 2. Non genetic personalised advice: dietary and physical activity advice based on reported dietary intake and physical activity 3. Genotype- based personalised advice: dietary and physical activity advice based on genotype, reported dietary intake and physical activity. Following allocation to groups participants in groups 2 and 3 will receive appropriate dietary and physical activity advice via email (appendix a) and all participants will complete the healthy eating motivation questionnaire for a second time. In April/May 2020 follow up variables (smoking status, weight, BMI, WC, BF%, healthy eating motivation, dietary intake and physical activity) will be measured again. These follow up variables will be measured every September and April/May until September 2022. After each follow up participants in groups 2 and 3 will be resent their dietary and physical activity advice and updated information based on their reported dietary intake and physical activity.

Eligibility criteria: Inclusion Criteria:

• Age 18-25 years

Exclusion Criteria:

* Pregnancy and lactation
* Chronic disease
* A history of disordered eating and following a restricted diet.

Primary outcomes:
measure: Body weight in kg
timeFrame: 3 years
measure: Body fat percentage
timeFrame: 3 years
measure: Body mass index in Kg/m2
timeFrame: 3 years
Secondary outcomes:
measure: Dietary intake
timeFrame: 3 years
measure: Physical activity
timeFrame: 3 years
measure: Participants motivation to eat healthily
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06536504: A Randomized Controlled Trial to Assess the Impact of Live and Recorded Music-Based Interventions on Pre-operative Stress, Mood, Pain and Biomarkers, in Neurosurgical Patients (Music-STAR Trial)
Official title: A Randomized Controlled Trial to Assess the Impact of Live and Recorded Music-Based Interventions on Pre-operative Stress, Mood, Pain and Biomarkers, in Neurosurgical Patients (Music-STAR Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress
Pain
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study plans to enroll a total of 132 patients. The goal of this study is to measure pre-and post-music intervention changes in patients' vital signs, serum- and plasma-level biomarkers by broad-spectrum proteomics analysis, metabolic analysis, and perceived pain, anxiety, and mood states as measured by validated questionnaires (STAI-S, POMS-SF, and VASP). We will collect demographic information on each participant. Participants will also complete the Brief Musical Experience Questionnaire (BMEQ) to investigate potential links between susceptibility to music-induced anxiolysis and prior musical training, preference and exposure.

Detailed description: Primary Objectives:

* To evaluate the effects of the two (live and recorded) prescribed preoperative containing CER on physiologic and perceived stress in patients undergoing Neurosurgery.
* To evaluate the effects of those two music interventions on serum- and plasma-level stress biomarkers and cytokines in those patients.

Secondary Objectives:

• To measure correlative effects of demographic variables, prior musical training, experience, preference, and exposure to music.

Eligibility criteria: Inclusion Criteria

1) Patients undergoing neurosurgical procedures will be eligible to enroll in this study.

Exclusion Criteria

1. Patient is unable or unwilling to provide informed consent.
2. Patient is deaf or hearing-disabled.
3. Patient is less than 18 years in age.
4. Patient was previously enrolled in the study.
5. Non-English-speaking patients (patient must be fluent in English and not require translation services per MDACC institutional policy.
6. Subjects on contact isolation precautions.

Primary outcomes:
measure: Stress and mood changes
timeFrame: Through study cmpletion
measure: Stress biomarkers
timeFrame: Through study completion
Secondary outcomes:
measure: BMEQ (Brief Music Experience Questionnaire)
timeFrame: Through study completion
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Mei Rui, DMA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06457204: A Study in Healthy People to Compare Two Different Sifrol® Tablets
Official title: Bioequivalence of Two Sifrol® Tablets Following Oral Administration in Healthy Subjects (an Open-label, Randomised, Single-dose, Two-way Crossover Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-06-13
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main objective of this trial is to establish the bioequivalence of Sifrol® tablets manufactured at two different sites.


Eligibility criteria: Inclusion Criteria:

1. Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical histo1y including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 55 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply.

Exclusion Criteria:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.

Primary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
timeFrame: up to 3 days
measure: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: up to 3 days
Secondary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
timeFrame: up to 3 days
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: Humanpharmakologisches Zentrum Biberach
Study officials:
References:
Clinical trial NCT04799704: Tear Film SARS-nCoV-2 Detection in Symptomatic and Pauci-symptomatic Patients.
Official title: Tear Film SARS-nCoV-2 Detection in Symptomatic and Pauci-symptomatic
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Covid19
Eye Diseases
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: positive test for SARS-nCoV-2 on a nasopharyngeal swab.

Brief summary: To investigate the presence of SARS-nCoV-2 in the tear film of symptomatic and pauci-symptomatic SARS-nCoV-2 positive patients.

Detailed description: The end goal of the study is to show whether or not the virus can be found in the tear film in both symptomatic and less symptomatic patients by means of serial sampling.

A sample of the tears / conjunctiva will be taken with a soft brush (similar to a cotton swab) every three days until the end of the hospitalization. In addition, you must complete a questionnaire that assesses the symptoms present.

Eligibility criteria: Inclusion Criteria:

* Subject needs to be above 18 years old.
* The subject is willing to undergo sampling of the conjunctiva.
* The subject is willing to fill in a questionnaire.
* The subject is fluent in written and verbal Dutch.
* The subject is capable of giving informed consent.
* Applicable for part 1 only: the subject test positive for SARS-nCoV-2 on a nasopharyngeal swab. The time window between a positive nasopharyngeal swab and the first conjunctival swab may be no more than 3 days.

Exclusion Criteria:

* Allergy to Oxybuprocainehydrochloride
* Pregnancy or lactation

Primary outcomes:
measure: The Presence of SARS-nCoV-2 in the Tear Film of Symptomatic and Pauci-symptomatic SARS-nCoV-2 Positive Patients.
timeFrame: during hospitalization every 3 days until the day of discharge up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams Brabant
Study officials:
affiliation: UZ Leuven
name: Delbeke Heleen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leysen L, Delbeke H, Desmet S, Schauwvlieghe PP, Maes P, Blanckaert G, Matthys E, Joossens M, Casteels I. In search of viable SARS-CoV-2 in the tear film: a prospective clinical study in hospitalized symptomatic patients. Clin Microbiol Infect. 2022 Aug;28(8):1172-1173. doi: 10.1016/j.cmi.2022.03.026. Epub 2022 Mar 31. No abstract available.