louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00886912: Training in Hypoxia to Prevent Acute Mountain Sickness
Official title: Prevention of Acute Mountain Sickness (AMS) by Intermittent Hypoxic Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Mountain Sickness
Healthy
Keywords: mountain sickness
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2009-04-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Some studies suggest that high-altitude related illnesses - like acute mountain sickness - could be prevented by acclimatisation, reached at low altitude using training in simulated altitude. The purpose of this study is to determine whether training in hypoxia is suitable to prevent acute mountain sickness.

Detailed description: In a three week-period, healthy probands undergo 3 times a week a bicycle ergometer training in simulated altitude followed by 1 week passive exposure at simulated low altitude. 5 days after last exposure, a field study starts performing a rapid ascent to the Capanna Regina Margherita (4559m). Acute mountain sickness is assessed by established scoring systems.

Eligibility criteria: Inclusion Criteria:

* healthy
* non-smoker
* endurance training min. 2x/week

Exclusion Criteria:

* any diseases
* previous exposure to altitudes higher than 2000m (last 6 weeks)

Primary outcomes:
measure: Incidence of acute mountain sickness
timeFrame: after 20 hours at 4559m
Secondary outcomes:
measure: Severity of acute mountain sickness
timeFrame: after 20 hours at 4559m
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Departement of Sports Medicine, University of Heidelberg
Study officials:
affiliation: Departement of Sports Medicine, University of Heidelberg
name: Kai Schommer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06670612: The Effect of Nature-Based Music Concert on Intensive Care Patients
Official title: The Effect of Nature-Based Music Concert on Pain and Physiological Parameters in Intensive Care Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Patient Care
Patient Care in ICU
Keywords: music
pain
nature based music
physiological parameter
Lead sponsor: İstanbul Yeni Yüzyıl Üniversitesi
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Purpose: This study was planned to determine the effect of nature-based music recital on pain and physiological parameters in intensive care patients.

Design: This research will be conducted as a pre-test post-test randomized controlled intervention study. Patient Information Form, Numerical Pain Scale and Physiological Parameters Tracking Form will be used as data collection forms.

H1: Nature-based music recital has an effect on pain level

H2: Nature-based music recital has an effect on physiological parameters


Eligibility criteria: Inclusion Criteria:

* Being 18 years or older
* Having orientation to place and time
* No communication (visual, auditory) barriers
* No neuromuscular blockade with medication
* Not applying nerve block,
* Not having peripheral neuropathy or quadriplegia
* Sedation level 1, 2, 3 and 4 according to the Ramsey Sedation Scale (RSS)

Exclusion Criteria:

* Glasgow Coma Scale score below 13 points
* Being diagnosed with a psychiatric disease
* Having dementia/brain dysfunction
* Having a hearing-related anomaly or health problem
* The patient has not undergone any painful procedure within the last hour.
* Sedation level should be 5 and 6 according to RSQ

Primary outcomes:
measure: Numerical Pain Scale
timeFrame: 1 hour from the music concert to the end of the application
measure: Physiological Parameters Tracking Form
timeFrame: 1 hour from the music concert to the end of the application
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Yeni Yuzyil University
Study officials:
References:
Clinical trial NCT06977412: The Application Value of Spectral CT in the Accurate Staging of Breast Cancer
Official title: The Application Value of Spectral CT in the Accurate Staging of Breast Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Adenocarcinoma
Lead sponsor: Yunnan Cancer Hospital
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Spectral CT was used to prospectively collect medical images and clinical data related to breast cancer, evaluate the effect of image quality in the diagnosis of breast cancer, and evaluate the application value in the accurate staging of breast cancer, so as to provide a more accurate clinical basis for diagnosis, promote the development of individualized treatment, and ultimately improve the prognosis of patients.


Eligibility criteria: Inclusion Criteria:

* (a) Chest quark energy spectrum CT examination was performed within 1 week before treatment
* (b) Age ≥ 18
* (c) Suspected breast cancer patients
* (d) Patients who signed informed consent

Exclusion Criteria:

* (a) Severe cardiac, pulmonary and renal insufficiency
* (b) Allergic to iodine contrast media
* (c) Unable to cooperate to complete CT examination
* (d) Quark spectrum CT image is poor and cannot be used
* (e) Male, pregnant and lactating female
* (f) Combined with other tumor history
* (g) Incomplete clinical and pathological data
* (h) Pathologically confirmed non breast cancer

Primary outcomes:
measure: Pathological TNM staging
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ethics Committee of Yunnan Provincial Cancer Hospital
name: Lianhua Ye
role: STUDY_DIRECTOR
References:
Clinical trial NCT02565212: Comparison of the Effects of Nasal Steroids and Montelukast on Olfactory Functions in Patients With Allergic Rhinitis
Official title: Istanbul Gaziosmanpasa Taksim Research and Training Hospital,
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Rhinitis
Keywords: Montelukast
Sniffin' Sticks test
allergic rhinitis
mometasone furoate
Lead sponsor: Istanbul Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2015-10-01
Enrollment: 30
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 investigators aimed to evaluate by the Sniffin' Sticks test the effects on olfactory functions of nasal steroids and leukotriene antagonists used for allergic rhinitis.Thirty patients with seasonal were included in this study. Patients were randomly divided into three groups of 10 patients; group 1 received montelukast sodium and mometasone furoate therapy, group 2 received only montelukast, and group 3 only mometasone furoate. Patients' olfactory functions were determined using the Sniffin' Sticks olfactory test before and after a month treatments.

Threshold, discrimination, identification, and TDI values were not significantly different among the groups before treatment. For Group 1 and Group 3 patients, there were statistically significant differences in threshold, discrimination, identification, and TDI values before and after treatment (p \< 0.05) (Wilcoxon signed ranks analysis) For Group 2 patients, the before and after treatment values of threshold, discrimination, identification, and TDI showed no significant differences (p \> 0.05). According to the findings of our study, MF is superior to montelukast in improving olfactory function. Although montelukast has been shown to be effective against AR symptoms, its effect on olfactory function was not demonstrated in this study.


Eligibility criteria: Inclusion Criteria:

* Positive skin test to grass and/or tree pollens in patients with clinical history of seasonal AR for at least 1 year

Exclusion Criteria:

* Patients who had received drug treatment or immunotherapy before the study were excluded.
* Patients with asthma, deviated nasal septum, history of nasal operation, turbinate hypertrophy, nasal polyposis or chronic nasal disorders, pregnancy, or upper airway infections were also excluded.

Primary outcomes:
measure: Comparison of the effects of nasal steroids and montelukast on olfactory functions in patients with allergic rhinitis
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05923112: BESPONSA Injection 1 mg Special Investigation
Official title: BESPONSA® INJECTION 1 MG SPECIAL INVESTIGATION
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lymphocytic Leukemia
Keywords: Drug use investigation in Japan
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-06-28
Enrollment: 421
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who received BESPONSA

Brief summary: The purpose of this study is to learn about the safety and effectiveness of BESPONSA. BESPONSA is approved for treatment of relapsed or refractory CD22-positive acute lymphocytic leukemia.

Registration criteria for this study is all patients who starting BESPONSA from its launch to the market to April 30, 2020.

All patients in this study will receive BESPONSA according to the prescriptions.

Patients will be followed up as follow.

* 52 weeks for patients who did not have a HSCT (Hematopoietic Stem Cell Transplant) within 52 weeks after starting BESPONSA.
* Up to 52 weeks after a HSCT for patients who had a HSCT within 52 weeks after starting BESPONSA.


Eligibility criteria: Inclusion Criteria:

* All patients prescribed BESPONSA

Exclusion Criteria:

* None

Primary outcomes:
measure: The incidence of adverse drug reactions
timeFrame: Up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01379612: Ultrasound Elastography in Patients With Rectal Cancer
Official title: Ultrasound Elastography of Rectal Cancer Patients Treated With Preoperative Chemoradiation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Keywords: Ultrasound elastography
Rectal cancer
Preoperative chemoradiation
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2011-06-23
Enrollment: 31
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: Rectal cancer patients planned for preoperative chemoradiation at the Dept. of Oncology, Vejle Hospital, Denmark.

Brief summary: The aim of this study is to recruit 50 rectal cancer patients planned to receive standard radiochemotherapy. A baseline ultrasonic elastography is performed prior to radiochemotherapy and followed by re-scans two and six weeks after initiation of treatment. The objective quantitative elastography findings are compared with the TRG score.

The purpose is to elucidate ultrasonic elastography's ability to predict treatment response at an early stage by comparing quantitative ultrasound parameters before, during and after treatment with MR scan results and histopathological Tumor Regression Grade (TRG score) after operation.


Eligibility criteria: Inclusion Criteria:

1. Patients with biopsy verified adenocarcinoma in the rectum ≤ 10 cm from the anal verge.
2. T3/4 tumor assessed by transrectal ultrasound and MR, and CRMMR \< 5 mm.
3. Life expectancy of more than 3 months.
4. Age ≥18 years.
5. Performance status ≤ 2 according to WHO.
6. Patient able to observe protocol guidelines.
7. Signed informed consent.

Exclusion Criteria:

1. Previous radiation treatment for the pelvis.
2. Known distant metastases.
3. Serious disease contraindicating treatment, including cardiovascular disease.
4. Other malignant disease apart from curativly treated non-melanotic skin cancer and previously treated carcinoma in situ cervicis uteri.
5. Pacemaker
6. other disease making the patient unfit for study participation as assessed by investigator

Primary outcomes:
measure: Tumor regression grade
timeFrame: 8 weeks after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Dept. of Oncology, Vejle Hospital
city: Vejle
country: Denmark
facility: Dept. of Radiology, Vejle Hospital
Study officials:
References:
Clinical trial NCT05517512: Relation Between Protein 13 and Gestational Hypertensive Disorder
Official title: Low Serum Pregnancy Protein 13 Early in Pregnancy Might Predict the Oncoming Gestational Hypertensive Disorders, Especially Early-onset Preeclampsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Hypertension
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 138
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 33
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Non Hypertensive pregnant women

Brief summary: the attendants of the clinic with a one-missed period (T0) underwent determination of baseline blood pressure (BP) measures and gave blood samples for estimation of levels of placental growth factor (PLGF), soluble fms-like tyrosine kinase-1 (sFlt-1) and pregnancy protein 13 (PP13). The same evaluation was repeated on the 6th, 24th, 32nd, and 36th gestational week (GW). Twenty non-pregnant women gave samples as a negative control group.


Eligibility criteria: Inclusion Criteria:

* Normotensive women who attended the clinic with a one-missed period (T0)

Exclusion Criteria:

* History of essential hypertension (HTN)
* renal diseases
* hepatic diseases
* cardiac diseases
* metabolic syndrome
* body mass index (BMI) \>35 kg/ m2
* congenital heart diseases

Primary outcomes:
measure: Serum biomarkers and GHD
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Banha University
state: El- Qalyobia
Study officials:
References:
Clinical trial NCT01932112: Adenosine Effect on Persistent Pulmonary Vein Isolation Line Evaluation (APPLE Trial)
Official title: Adenosine Effect on Persistent Pulmonary Vein Isolation Line Evaluation (APPLE Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Persistent Common Pulmonary Vein
Keywords: Pulmonary Vein Isolation
Adenosin effect
Atrial fibrillation ablation
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2013-08-30
Enrollment: 378
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: The investigators studied the effects of adenosine on the reconnection rate after successful pulmonary veins isolation by radiofrequency catheter ablation in patients with drug-resistant atrial fibrillation

Detailed description: Pulmonary vein isolation has emerged as an effective therapy for paroxysmal atrial fibrillation. However, atrial fibrillation recurs in up to 50% of patients, generally because of recovery of pulmonary vein conduction.

Adenosine given during the initial procedure may reveal dormant pulmonary vein conduction, thereby identifying the need for additional ablation, leading to improved outcomes.

Eligibility criteria: Inclusion Criteria:

* Diagnosed atrial fibrillation
* recurrence of symptomatic atrial fibrillation in spite of Antiarrhythmic drug use
* written informed consent

Exclusion Criteria:

* intracardiac thrombus
* pregnancy

Primary outcomes:
measure: Reconnection of Pulmonary Vein Electrogram After Adenosine Infusion
timeFrame: 5 minutes after IV adenosine
Secondary outcomes:
measure: Atrial Fibrillation Recurrence
timeFrame: between 0 and 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul st Mary's Hospital
state: Seocho-Ku
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Yong seog Oh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim JY, Kim SH, Song IG, Kim YR, Kim TS, Kim JH, Jang SW, Lee MY, Rho TH, Oh YS. Achievement of successful pulmonary vein isolation: methods of adenosine testing and incremental benefit of exit block. J Interv Card Electrophysiol. 2016 Sep;46(3):315-24. doi: 10.1007/s10840-016-0122-9. Epub 2016 Mar 9.
Clinical trial NCT00158912: VAST - Ventricular Arrhythmia Suppression Trial
Official title: Ventricular Arrhythmia Suppression Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tachycardia
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of VAST is to determine whether the Rate Smoothing feature in Guidant's PRIZM/VITALITY-family ICDs has an effect on the incidence of ventricular tachyarrhythmias.


Eligibility criteria: Inclusion Criteria:

* Patients who receive a commercially available Guidant PRIZM, PRIZM 2, or VITALITY AVT ICD
* Patients who sign and date a Patient Informed Consent prior to study enrollment
* Patients who remain in the clinical care of physicians of their implanting center

Exclusion Criteria:

* Patients who have chronic atrial fibrillation. Paroxysms of AF are not an exclusion criterion, but the patient must be in normal sinus rhythm at the time of randomization. If history of AF is unknown or uncertain, or the patient was recently cardioverted, there must be at least 23 hours of normal sinus rhythm within the 24 hour period preceding randomization
* Patients who previously had an ICD
* Patients with current indications for cardiac resynchronization therapy with defibrillation (CRT-D)
* Patients whose life expectancy is less than 12 months due to other medical conditions
* Patients who are expected to receive a heart transplant during the duration of the study
* Patients who have or who are likely to receive a tricuspid or other valve prosthesis
* Patients who are currently enrolled in another investigational study of active medical therapy. Each instance should be brought to Guidant's Clinical Application Research Studies (CARS) group to determine eligibility
* Patients who are younger than 18 years of age
* Patients who are mentally incompetent and cannot give a Patient Informed Consent or participate in the study

Primary outcomes:
measure: The primary endpoint for this study will be the number of episodes of ventricular tachyarrhythmia in each patient during each follow-up period (ON vs. OFF treatment).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Paul Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00693212: Further Studies of Attention Deficit Disorder - Residual Type (RT)
Official title: Further Studies of Attention Deficit Disorder - Residual Type
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Adult
crossover
randomized
Long-term
Open-label
methylphenidate
Social adjustment
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-06-06
Enrollment: 116
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The first phase was a double-blind crossover design of methylphenidate in the treatment of adult ADHD. The second phase consisted of an open-label extension trial of methylphenidate in adult ADHD. It was hypothesized that methylphenidate would prove more effective than placebo in treating ADHD symptoms during the first phase. It was also hypothesized that methylphenidate responders from the double-blind trial would continue to benefit from treatment in the second phase. Improvement would include both ADHD symptoms and social adjustment.

Detailed description: All patients received a single-blind week on placebo, followed by a double-blind random assignment crossover trial of methylphenidate and placebo, with each double-blind phase lasting two weeks. Subjects who experienced moderate or marked improvement on methylphenidate would be allowed to enter a long-term, open-label trial. ADHD symptom severity was measured monthly by a structured interview, the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS), Clinical Global Impression - Improvement (CGI-I) and Global Assessment of Functioning (GAF). Social functioning was assessed by the clinician administered version of the Weissman Social Adjustment Scale (WSAS). Dosing was determined by clinical judgement, symptom improvement and AEs.

Eligibility criteria: Inclusion Criteria:

* Ages 21-55 years; male and female; met "Utah Criteria" for adult ADHD; 95th or higher percentile on the Parent Rating Scale and/or the Wender Utah Rating Scale;

Exclusion Criteria:

* Patients with other axis-I and axis-II diagnoses were excluded as were patients with significant medical problems.

Primary outcomes:
measure: Wender-Reimherr Adult Attention Deficit Disorder Scale
timeFrame: Monthly
Secondary outcomes:
measure: Clinical Global Impression - Improvement
timeFrame: monthly
measure: The Global Assessment of Functioning (GAF).
timeFrame: monthly
measure: The Weissman Social Adjustment Scale (WSAS)
timeFrame: At termination
Other outcomes:
Locations:
city: SLC
country: United States
facility: Univ of Utah, School of Medicine, Mood Disorders Clinic
state: Utah
Study officials:
affiliation: University of Utah
name: Paul H Wender, MD
role: PRINCIPAL_INVESTIGATOR
References: