louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05186025: Tyrosine Allergoid Paediatric and Adult Study
Official title: A Long-term, Prospective, Open, Multi-centre, Non-interventional Study to Evaluate the Effectiveness After Treatment with TA Bäume Top (trees) and TA Gräser Top (grass) Following a Perennial Posology in Children and Adults, As Well As Proofing the Non-inferiority of Children Compared to Adults
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Allergic Rhinitis Due to Pollen
Allergic Conjunctivitis
Allergic Asthma
Keywords: Allergy
Lead sponsor: Allergy Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Bencard Allergie GmbH
First posted: 2022-01-11
Enrollment: 320
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults, adolescents and children from the age of 5 on, who are going to be treated with TA Bäume or TA Gräser.

Brief summary: The primary objective of this 5-year study is to demonstrate non-inferiority of children compared to adults by exploring long-term effectiveness after treatment with TA Bäume (trees) and TA Gräser (grass) following a perennial posology.


Eligibility criteria: Inclusion Criteria:

* Patients from 5 years of age who are treated with TA Gräser top or TA Bäume top due to rhinitis, conjunctivitis and/or mild to moderate bronchial asthma, which are caused by an IgE-mediated allergy to grass and rye pollen or birch, alder and hazel pollen according to the respective SmPC.
* Patients will only be included in this study after the decision on the treatment has been made.

Exclusion Criteria:

* History of allergen-specific immunotherapy (SIT) for trees or grass within the last 5 years
* If it´s intended to treat the patient with only a preseasonal therapy
* A patient should also not be included in the presence of any of the conditions listed in the respective SmPC

Primary outcomes:
measure: change in the combined symptom medication score (CSMS)
timeFrame: once a year for 5 years
Secondary outcomes:
measure: rhinoconjunctivitis daily medication score
timeFrame: once a year for 5 years
measure: rhinoconjunctivitis daily symptom score
timeFrame: once a year for 5 years
measure: Rhinoconjunctivitis Quality of Life
timeFrame: twice a year for 5 years
measure: Rhinitis Control
timeFrame: twice a year for 5 years
measure: Asthma Control
timeFrame: twice a year for 5 years
measure: Incidence of Treatment-Emergent Adverse Events (safety and tolerability)
timeFrame: all year for 3 years
measure: treatment satisfaction
timeFrame: once after 3 years and once after 5 years
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg
Study officials:
affiliation: ClinCompetence Cologne GmbH
name: Ralph Moesges, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01317225: Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor With Progesterone
Official title: Use of 17α Hydroxyprogesterone Caproate for the Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor During Current Pregnancy. Double Blind, Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Preterm Birth
Obstetric Labor, Premature
Keywords: Progesterone
Obstetric labor, premature
Short cervix
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2011-03-17
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if the use of 250 mg of intramuscular progesterone biweekly can reduce the incidence of preterm labor in patients with an episode of threatened preterm labor during the current pregnancy.

Detailed description: Preterm birth is one of the main causes of neonatal mortality and morbidity around the world, with serious repercussions on the health system and the families of the preterm baby. Many drugs have been evaluated with the purpose of preventing preterm birth in the patient at risk. One of these drugs is 17 α hydroxyprogesterone caproate. The purpose of this study is to evaluate if the use of biweekly doses of 17 α hydroxyprogesterone caproate in patients hospitalized with the diagnosis of threatened preterm labor, defined as the presence of uterine contractions and a short cervix (below the 10th percentile for the gestational age), can reduce the incidence of preterm birth in this high risk group population.

Eligibility criteria: Inclusion Criteria:

* Pregnant women between 26 and 34 weeks of gestation.
* Cervical length (determined by transvaginal ultrasound) below the 10th percentile for the gestational age.

Exclusion Criteria:

* Multiple gestations.
* Maternal pathologies in which preterm termination of pregnancy is required.

Primary outcomes:
measure: Incidence of preterm birth (before 37 weeks of gestation)
timeFrame: 18 months
Secondary outcomes:
measure: Incidence of preterm birth before 35 weeks of pregnancy
timeFrame: 18 months
measure: Incidence of preterm birth before 32 weeks of pregnancy
timeFrame: 18 months
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas Maternity Hospital
Study officials:
affiliation: Saint Thomas Maternity Hospital
name: Osvaldo A Reyes, MD (Gyn/Ob)
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Thomas Maternity Hospital
name: Rodrigo Velarde, MD (Gyn/Ob)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00763425: Prospective Randomized Comparison of Cold Snare Polypectomy and Conventional Polypectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: polypectomy
colonic polyp
colorectal polyp
colorectal cancer prevention
Lead sponsor: Showa Inan General Hospital
Sponsor class: OTHER
First posted: 2008-10-01
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare cold snare polypectomy and conventional polypectomy for the removal and retrieval of small colorectal polyps.

Cold snare polypectomy for colorectal polyps up to 8 mm is expected to be more effective than conventional polypectomy.


Eligibility criteria: Inclusion criteria:

* Men or women between 20 and 100 years of age

Exclusion Criteria:

* Exclusion criteria include age less than 20 years old
* Pregnant, American Society of Anesthesiologists class III and IV
* Overweight (body weight \> 100 kg)
* Allergic to the drugs used or its components (soybeans or eggs)
* Poor bowel preparation or post-colorectal surgery.

Primary outcomes:
measure: Complete removal rate of colorectal polyps
timeFrame: two weeks after each polypectomy
Secondary outcomes:
measure: Complication rate
timeFrame: two weeks after each polypectomy
Other outcomes:
Locations:
city: Komagane
country: Japan
facility: Showa Inan General hospital
state: Nagano
Study officials:
References:
Clinical trial NCT06985225: Evaluation of Ventilation Defects Downstream of Mucus Plugs in Patients With Severe Asthma
Official title: Evaluation of Ventilation Defects Downstream of Mucus Plugs in Patients With Severe Asthma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Asthma
Keywords: Xenon MRI
Mucus Plug
Severe Asthma
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Polarean Imaging, Plc
First posted: 2025-05-22
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with High T2 Severe Asthma

Brief summary: In this study, xenon MRI will be used to evaluate regional functional consequences of mucus plugs in the lungs of patients with severe asthma. Mucus plugs will be identified using CT imaging, and xenon MRI will be used to evaluate ventilation and gas exchange impairments in regions of the lungs corresponding to the airways downstream of mucus plugs.


Eligibility criteria: Inclusion Criteria:

* Adequate completion of informed consent process with written documentation
* Patients 18 - 65 years old
* Physician diagnosis of asthma for \> 1 year
* Able to perform reproducible spirometry according to ATS criteria based on clinical PFTs.
* Blood eosinophil count \> 300 cells/μL and FeNO \>25ppb
* Smoking history \<10 pack years
* No smoking history (including vapes, cigar, or marijuana use) in the last 3 months
* Approved for asthma therapy with either dupilumab, tezepelumab, or benralizumab as part of their standard of care

Exclusion Criteria:

* Respiratory tract infection within the 4 weeks prior to Visit 1
* Body mass index (BMI) \> 30 at Visit 1
* One-time doses such as intra-articular injections require a 4-week washout prior to Visit 1
* Asthma-related ER visit within the previous 4 weeks of Visit 1
* Significant concomitant medical illness, including (but not limited to) heart disease, cancer, uncontrolled diabetes, other chronic lung diseases (determined by the Investigator.)
* Resting O2 saturation \<90% with maximum supplemental O2 delivered by nasal canula
* Positive urine pregnancy test at Visit 1 or at any time while on the study
* Participation in an intervention study (including bronchoscopy) or use of investigative drugs within the past 30 days or plans to enroll in such a trial during the study
* Unable or unlikely to complete study assessments in the opinion of the Investigator
* Study intervention poses undue risk to patient in the opinion of the Investigator
* Conditions that will prohibit MRI scanning determined by the MRI safety screening.

Primary outcomes:
measure: Ventilation Defect in Mucus blocked Regions
timeFrame: 12-weeks
Secondary outcomes:
measure: Change in VDP
timeFrame: 4-weeks
measure: Long term change in VDP
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
References:
Clinical trial NCT00370825: Combination Chemotherapy for the Treatment of Indian Kala-Azar
Official title: Combination Chemotherapy for the Treatment of Indian Visceral Leishmaniasis: Miltefosine Plus Liposomal Amphotericin B - Dose and Duration Ranging Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Visceral Leishmaniasis
Keywords: Visceral leishmaniasis
miltefosine
AmBisome
Combination
Lead sponsor: Banaras Hindu University
Sponsor class: OTHER
First posted: 2006-09-01
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are using a sequential design to combine miltefosine and AmBisome in different doses.

Detailed description: In this sequential design four arm study one arm is a reference arm but the three arms will consist an of initial dose of liposomal amphotericin B on first day followed by miltefosine. Both the drugs will be used in different doses. Reference arm will consist only a single dose of amBisome at 5 mg/kg. After the end of treatment, the post treatment assessment will be done on day 16 (initial cure) and six months (final cure). Safety parameters will be evaluated on day 0, 8 and 16. An arm with an efficacy of less than 75% will be closed. There will be periodical assessment of study results after completion of 5 patients in each arm.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of active VL with consistent signs and symptoms (e.g., fever, splenomegaly).
* Confirmed diagnosis by bone-marrow or splenic aspirate smear showing characteristic amastigotes.
* Male or female.
* Ages 12 to 65 years.
* Both newly diagnosed cases and patients who have received previous treatment (in the latter case a 2-week wash-out will be required before starting the study treatment).
* WBC \> 1,000/mm3.
* Hemoglobin ≥ 4 g/dL

Exclusion Criteria:

* Pregnancy or breast-feeding.
* HIV positive serology.
* ASAT, ALAT, AP ≥ 3 times upper limit of normal range.
* Bilirubin ≥ 2 times upper limit of normal range.
* Prothrombin time ≥ 5 seconds above control.
* Serum creatinine or BUN ≥ 1.5 times upper limit of normal range.
* Any medical condition or situation that compromises compliance with study procedures.
* HIV

Primary outcomes:
measure: Absence of clinical kala-azar at six month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Muzaffarpur
country: India
facility: Kala-azar Medical Research Center
state: Bihar
Study officials:
affiliation: Banaras Hindu University
name: Shyam Sundar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sundar S, Rai M, Chakravarty J, Agarwal D, Agrawal N, Vaillant M, Olliaro P, Murray HW. New treatment approach in Indian visceral leishmaniasis: single-dose liposomal amphotericin B followed by short-course oral miltefosine. Clin Infect Dis. 2008 Oct 15;47(8):1000-6. doi: 10.1086/591972.
Clinical trial NCT03507725: Early Staged Consent Before Prostate Biopsy
Official title: Improving Patient Experience and Outcomes for Men Undergoing Prostate Biopsy: A Randomized Controlled Trial With Early Stage Consent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: mind-body intervention
18-189
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 390
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a study and a novel approach to clinical trials, testing the feasibility and acceptability of two-stage consent in the context of a trial integrated into routine clinical practice. The investigator will use, as a model, a trial of a brief mind-body intervention) with guided imagery for procedural pain at the time of prostate biopsy. In the two-stage design, patients will first be approached for consent to 1) have their routinely collected clinical data used for research purposes and 2) be randomly selected to be offered an intervention to improve the experience of prostate biopsy. Only patients randomized to the experimental arm will be informed about the benefits and harms of the intervention and will sign a second consent for the experimental treatment. There will be two separate randomizations in this study, one-stage (usual informed consent) vs. two-stage consent and mindfulness intervention vs. control.


Eligibility criteria: Inclusion Criteria:

* All male patients that will be scheduled for standard prostate needle biopsy (first, repeat or active surveillance biopsy) under local anesthesia and potentially consented to the mindfulness study of mind-body intervention for prostate biopsy within the next 12 months.
* English fluent

Exclusion Criteria:

* Patient with prior rectal surgery or anal stricture requiring surgical intervention prior to biopsy.
* Prior prostate radiation

Primary outcomes:
measure: number of patients who sign consent form
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Behrar Ehdaie, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02114125: Effects of the Physical Activity and Cognitive Training Program
Official title: The Effects of Physical Activity and Cognitive Training in Improving Cognitive Function of Institutionalized Older Residents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Decline
Keywords: Physical activity
Cognitive training
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2014-04-15
Enrollment: 270
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Investigators assume that there are some positive effects of cognitive training and physical activities on cognitive function, depression and quality of life in a sample of older residents in long-term care facilities.

The purpose of this study is to explore the effects of various interventions (physical activity, cognitive training, integration of physical activity and cognitive training) on different outcome indictors in institutionalized older residents.

Detailed description: 1. to develop an intervention protocol that achieves clinical development objectives in a scientifically rigorous and time efficient manner.
2. to further analyze the effects of the various interventions and make a comparison of dose-response relation and efficacy.

Eligibility criteria: Inclusion Criteria:

* Age 65 year and older
* Able to communicate verbally
* Able to discern 5\*5 cm2 picture from a viewing distance of 20 cm
* Able to hear a sound of normal speech from a distance of 20 cm
* Able to sit in a chair or wheelchair independently for more than 30 minutes without changes in vital signs and awareness and without physical discomfort
* Has cognitive decline status assessing by CASI 2.0
* Lived in long-term care facilities during the study

Exclusion Criteria:

* Complete aphasia, blindness, deafness or completely dependent
* Unstable angina, arrythmia, myocardial infarction history, postural hypotension, transient cerebral hypoxia or other psychiatric disorders except depression
* Thrombophlebitis, or malignancy of the limbs.
* Refusal by patient or family member.
* Others. Reason to be well documented.

Primary outcomes:
measure: Change from Baseline Cognitive Function at 8 weeks and 16weeks
timeFrame: pre-treatment (0 week, T0), post-treatment (8 weeks, T1) and follow-up (16 weeks, T2 )
Secondary outcomes:
measure: Change from Baseline Depression at 8 weeks and 16weeks
timeFrame: pre-treatment (0 week, T0), post-treatment (8 weeks, T1) and follow-up (16 weeks, T2 )
measure: Change from Baseline Quality of Life at 8 weeks and 16weeksStatus:
timeFrame: pre-treatment (0 week, T0), post-treatment (8 weeks, T1) and follow-up (16 weeks, T2 )
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan Unversity Hospital
Study officials:
affiliation: Department of Nursing, College of Medicine, National Taiwan University
name: Meei-Fang Lou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02566525: CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery
Official title: CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elective Cardiac Surgery
Keywords: CytoSorb device
Plasma free hemoglobin
inflammation
extracorporeal bypass
Lead sponsor: CytoSorbents, Inc
Sponsor class: INDUSTRY
First posted: 2015-10-02
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, multi-center, randomized, feasibility clinical study. Subjects will be randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care and treatment with the CytoSorb® device.


Eligibility criteria: Inclusion Criteria:

* Elective, cardiac surgery requiring cardiopulmonary bypass with anticipated duration of \>180 minutes

Exclusion Criteria:

* Platelet count \< 20,000/ uL
* Body mass index \<18
* Pregnant women
* Life expectancy of \<14 days
* End stage organ disease
* Active infection
* Undergoing cardiac transplant or ventricular assist device explant, isolated primary coronary artery bypass grafting (CABG) or single valve procedure
* Contraindication to anticoagulation with heparin
* Declined informed consent

Primary outcomes:
measure: Assessment of Serious Device Related Adverse Events
timeFrame: From time of enrollment through ICU discharge (e.g. ICU stay of approximately 4 days)
Secondary outcomes:
measure: Time in the ICU
timeFrame: From the end of cardiopulmonary bypass procedure through ICU discharge (e.g. ICU stay of approximately 4 days)
measure: 30 Day All Cause Mortality
timeFrame: From time of enrollment through 30 days post procedure
measure: Adverse Event Rates
timeFrame: through 30 days
Other outcomes:
measure: Change in Complement Factor C3a - 2 Hours Post Start of CPB
timeFrame: 2 hours post start of cardiac bypass
measure: Change in Complement Factor C3a - 3 Hours Post Start of CPB
timeFrame: 3 hours post start of CPB
measure: Change in Complement Factor C5a - 2 Hours Post Start of CPB
timeFrame: 2 hours post start of cardiac bypass
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Springfield
country: United States
facility: Baystate Medical
state: Massachusetts
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: New York
country: United States
facility: Columbia University
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: CytSorbents
name: Steve Sisk, MSc Pharm
role: STUDY_DIRECTOR
References: