louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05924581: Validation of Clinical Assessment of Spinal Stiffness
Official title: Validation of Clinical Assessment of Spinal Stiffness in Hyperkyphosis and Scoliosis During Growth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperkyphosis
Adolescent Idiopathic Scoliosis
Lead sponsor: Istituto Scientifico Italiano Colonna Vertebrale
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 25
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to validate and verify the reliability of the clinical measures used in the daily routine by doctors and therapists that allow assessing the spinal stiffness in all spatial planes. The secondary objective is the verification of the diagnostic accuracy of the most reliable tests in identifying the subjects at risk of failure, using as a radiographic standard the examinations performed by the patients during the treatment (data retrieved retrospectively) using as a control group those patients who did not obtain a correction of the spine curvature.


Eligibility criteria: Inclusion Criteria:

* Scoliosis \> 10°Cobb or Hyperkyophosis \>50° Cobb
* Age between 10 and 17 years old
* Risser between 0 and 5

Exclusion Criteria:

* History of spinal surgery
* Presence of back pain
* Diagnosis of congenital scoliosis or scoliosis secondary to neurological or muscular diseases

Primary outcomes:
measure: Reliability
timeFrame: through study completion, an average of 6 months
measure: Repeatability
timeFrame: through study completion, an average of 6 months
measure: Diagnostic accuracy
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: ISICO
state: Mi
Study officials:
References:
Clinical trial NCT01968681: Treatment of Nevus Flammeus With Alexandrite Laser
Official title: Treatment of Nevus Flammeus With Alexandrite Laser
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nevus Flammeus
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2013-10-24
Enrollment: 19
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Nevus flammeus is a congenital vascular malformation. Nevus flammeus is traditionally treated with pulsed dye lasers (PDL); however, around 20 percent of patients are poor responders and do not get satisfactory results from pulsed dye laser treatments.

Small studies with alexandrite lasers indicate that this may be an alternative treatment for individuals with nevus flammeus. This study assesses the clinical effect and side effects of alexandrite laser treatment for nevus flammeus using different treatment settings.


Eligibility criteria: Inclusion Criteria:

* 10 or more years of age
* Fitzpatrick Skin Type I-III
* Previously untreated or pulsed dye laser-insufficiently treated nevus flammeus
* Nevus flammeus size minimum 8 x 2 centimeter within one anatomical region
* Written and oral informed consent

Exclusion Criteria:

* Known light sensibility toward visible light
* Tendency to develop hypertrophic scars or keloids
* Fitzpatrick Skin Type IV-VI
* Individuals, that are obviously pigmented due to recent sun exposure or sun beds
* Treatment with systemic retinoids within 6 months
* Pregnancy and lactation
* Unwillingness to complete protocol

Primary outcomes:
measure: Reduction in clinical appearance on a 10-point scale
timeFrame: 6-8 weeks
Secondary outcomes:
measure: Skin reflectance measurement to assess degree of redness
timeFrame: 6-8 weeks
measure: Skin reflectance to assess degree of pigmentation
timeFrame: 6-8 weeks
Other outcomes:
measure: Clinical assessment of pigmentation
timeFrame: 6-8 weeks
measure: Clinical assessment of scar tissue formation
timeFrame: 6-8 weeks
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Merete Haedersdal, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02892981: Dead Space Evaluation in Pulmonary Hypertension
Official title: Dead Space Evaluation During Exercise in Patients With Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 18
Sex: ALL
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: Aim of the study is to evaluate the role of chemoreceptor activity and ventilation perfusion mismatch on the genesis of exercise induced hyperventilation in Pulmonary hypertension patients. So the investigators tested the chemoreceptor response at rest, both with hypoxic and hypercapnic stimuli, and the ventilatory response during exercise analyzing its two components, alveolar and dead space ventilation.


Eligibility criteria: Inclusion Criteria:

* age ≥18 and ≤ 80 years
* ability to understand the research protocol and willing to sign the study informed consent
* diagnosis of pulmonary arterial hypertension belonging to Class I and IV
* stable haemodynamic status and optimized medical treatment since at least 2 months
* ability to perform maximal cardiopulmonary exercise test and pulmonary diffusing capacity for carbon monoxide evaluation

Exclusion Criteria:

* relevant comorbidities
* usual contraindications for cardiopulmonary exercise test
* pulmonary hypertension associated to left heart and pulmonary disease, congenital heart diseases with evident cardiac shunts.

Primary outcomes:
measure: dead space ventilation (measured in L/min)
timeFrame: 1 week
Secondary outcomes:
measure: peripheral response to hypoxia (measured in L/min/O2)
timeFrame: 1 week
measure: peripheral response to hypercapnia (measured in L/min/mmHg)
timeFrame: 1 week
measure: central hypercapnic chemosensitivity (measured in L/min/mmHg)
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
References:
citation: Farina S, Bruno N, Agalbato C, Contini M, Cassandro R, Elia D, Harari S, Agostoni P. Physiological insights of exercise hyperventilation in arterial and chronic thromboembolic pulmonary hypertension. Int J Cardiol. 2018 May 15;259:178-182. doi: 10.1016/j.ijcard.2017.11.023.
Clinical trial NCT05583981: Stakeholder Assessment of Implementing the Commission on Cancer Operative Standards for Cancer Surgery
Official title: Stakeholder Assessment of Implementing the Commission on Cancer Operative Standards for Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-10-18
Enrollment: 31
Sex: ALL
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: Key stakeholders (e.g. electronic medical record \[EMR\] engineer, Cancer Liaison Physician \[CLP\], breast surgeon, and cancer registrar administrator) from Ohio State University and 3 other Commission on Cancer (CoC)-accredited cancer programs

Brief summary: This study investigates the barriers to implementing breast Synoptic Operative Reports. Information from this study may help researchers identify performance objectives for the breast Synoptic Operative Reports to be adopted, implemented and continued.

Detailed description: PRIMARY OBJECTIVES:

I. To identify and describe barriers to implementing breast Synoptic Operative Reports (SOR) from multiple constructs.

Ia. Identify performance objectives - who must do what - for the breast SOR to be adopted, implemented, and continued.

OUTLINE:

Participants participate in interview over 30-60 minutes.

Eligibility criteria: Inclusion Criteria:

* Adults \>= 18 years
* Available phone or device for contact
* English speaking
* Works at Commission on Cancer (CoC) - accredited cancer program

Exclusion Criteria: none

Primary outcomes:
measure: Barriers to implementing breast Synoptic Operative Reports
timeFrame: Up to 2 years
measure: Performance objectives for the breast Synoptic Operative Reports to be adopted, implemented, and continued
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Ko Un Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06638281: Reliability of the Incremental Shuttle Walk Test in University Students
Official title: Reliability of the Incremental Shuttle Walk Test in University Students
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incremental Shuttle Walk Test
Keywords: exercise tolerance
exercise test
Test-Retest Reliability
Reliability of Results
Lead sponsor: Siirt University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Siirt University Faculty of Health Sciences, Nursing Department students

Brief summary: The aim of this study is to evaluate the inter-rater and intra-rater reliability of the incremental shuttle walk test in university students.

Detailed description: The incremental shuttle walk test (ISWT) is a valid and reliable field test developed to evaluate functional exercise capacity. This test requires the participant to walk up and down a 10 m course marked by two cones placed 9 m apart. The walking speed, determined by an audio signal, is slow at first, but gradually increases every minute.

Although validity and reliability studies have been conducted in different disease groups and healthy populations, there is no study evaluating the inter-rater reliability of the incremental shuttle walk test in healthy individuals. Our research aims to evaluate the inter-rater and intra-rater reliability of the incremental shuttle walk test in university students.For this purpose, undergraduate nursing students will be included in our research.ISWT will be administered to students by two different researchers on the same day. For test-retest reliability the ISWT will be administered again by the same researchers on a different day (retest).

Eligibility criteria: Inclusion Criteria:

* Being a student of Siirt University Faculty of Health Sciences, Nursing Department
* Being between the ages of 18-26
* Understanding and speaking Turkish

Exclusion Criteria:

* Having a systemic, orthopedic or neurological disease
* Participant wishes to withdraw from the study

Primary outcomes:
measure: Incremental Shuttle Walk Test Results
timeFrame: At baseline and within 2-7 days after first assessment
Secondary outcomes:
measure: Age
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Smoking Status
timeFrame: Baseline
Other outcomes:
Locations:
city: Siirt
country: Turkey
facility: Siirt University
Study officials:
affiliation: Siirt University
name: Yasemin ACAR
role: STUDY_DIRECTOR
References:
Clinical trial NCT05292781: CHOICES3: Sickle Cell Disease Parenting CHOICES
Official title: CHOICES for Sickle Cell Reproductive Health: Randomized Clinical Trial (RCT) of a Preconception Intervention Model for a Single Gene Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sickle Cell Disease
Sickle Cell Trait
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Human Genome Research Institute (NHGRI)
First posted: 2022-03-23
Enrollment: 506
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will use web-based data collection (SCKnowIQ) and intervention delivery strategies enhanced by nudges and tailored boosters in a sample of 430 adult men and women, aged 18-45 yr with SCD (Sickle Cell Disease) or SCT (Sickle Cell Trait), at-risk, and planning within 2 years to have a child free of SCD.

Detailed description: In a 2-year, randomized, longitudinal, repeated measures, controlled trial in 430 at-risk young adults with SCD (50%) or SCT (50%) to compare the effects of e-Book (electronic-Book) and CHOICES interventions on knowledge and behaviors across time (baseline, immediate posttest, 6, 12, 18, 24 months). The study will provide boosters tailored to knowledge deficits at 6 and 12 months and add monthly reinforcement nudges toward concordant behavior during the first 12 months.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of SCD (HbSS, HbSC (Hemoglobin Sickle C Disease), HbS-beta-0 thalassemia, and HbS-beta+ thalassemia) or report of SCT (SCD is Hgb electrophoresis confirmed; SCT evaluated by SickleScan);
* Able and intends to conceive a child in the next 2 years (first child or another child);
* Speaks and reads English;
* 18 to 45 years;
* At-risk for having a child with SCD (i.e., sexual/ reproductive partner has SCD, SCT, or unknown sickle cell status); and
* Wants to avoid the risk of a child with SCD.
* The age range is based on typical reproductive age for SCD where median survival is 42 years for men and 48 years for women.

Exclusion Criteria:

* Legally blind;
* Physically unable to complete the study questionnaires or the intervention;
* Report health history of hysterectomy, tubal ligation, medically or surgically induced menopause, or vasectomy that would
* Prevent ability to bear children;
* Report a desire to remain childless or have no further children;
* Report knowing or being a relative or friend of a participant previously enrolled in the study, or
* Previous participation in a CHOICES study.

Primary outcomes:
measure: Sickle Cell Reproductive Health Knowledge
timeFrame: Baseline up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Diana Wilkie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05058781: Minipuberty in Infants Born With Potential Hypogonadism Hypogonadotrope
Official title: Evaluation of Minipuberty in Infants Born With a Variation in Sexual Development
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: DSD
CHH
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 100
Sex: ALL
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All infants born in canton de Vaud in Switzerland

Brief summary: Disorders of sex development (DSD) occur in 1/3000 births and are defined by variation in aspect of external genital organs, e.g. cryptorchidism, hypospadias and micropenis in male infants and clitoral hypertrophy in female infants. Genetic, hormonal and environmental factors are implicated in DSD. Infants with congenital hypogonadism hypogonadotrope (CHH) can present with DSD. Evaluation of hormonal profile during minipuberty could be of great help to better characterize the etiology of DSD and CHH in particular. Our main objective is to study hormonal profile during the minipuberty of infants born with DSD or born from parents with CHH compared to controls.


Eligibility criteria: Inclusion Criteria:

* infants born with symptoms of DSD
* infants born from parents with CHH

Exclusion Criteria:

* premature \< 35 weeks of gestation
* male infants with high scrotal cryptorchidism

Primary outcomes:
measure: Hormonal changes in blood and in urine during minipuberty (LH, FSH, steroid profile, Testosterone, Estradiol (in girls), AMH, inhibin B)
timeFrame: at 2, 6 and 9 months of age (window for minipuberty)
Secondary outcomes:
measure: quantification of Nitric Oxide metabolites during minipuberty
timeFrame: at 2, 6 and 9 months of age
measure: change in expression of genes involved in the NO pathway
timeFrame: at birth (if available), 2, 6 and 9 months of age
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
state: Vaud
Study officials:
affiliation: CHUV
name: Nelly Pitteloud, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06754410: Efficacy of Antihistamine Drugs as Medical Expulsive Therapy Alone or in Combination With Alpha Blockers: A Prospective Randomized Controlled Study
Official title: Efficacy of Antihistamine Drugs as Medical Expulsive Therapy Alone or in Combination With Alpha Blockers: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lower Ureteric Stones
Keywords: stones , ureter, tamsulosin
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: we investigate the Efficacy of Antihistamine Drugs as Medical Expulsive Therapy Alone or in Combination with Alpha Blockers in distal ureter stone


Eligibility criteria: Inclusion Criteria:

* all adult patients with lower ureter stone less than 10 mm

Exclusion Criteria:

* pregnant, solitary kidney, sensitivity to drugs

Primary outcomes:
measure: ureter stone free rate
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Qena
country: Egypt
facility: Qena university hospital
Study officials:
References:
Clinical trial NCT04345510: Testing for COVID-19 Infection in Asymptomatic Persons
Official title: Testing for COVID-19 Infection in Asymptomatic Persons
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Infection
Lead sponsor: German Cancer Research Center
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 500
Sex: ALL
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: DKFZ employees

Brief summary: Intensive action has been taken around the globe to fight the corona virus SARS-COV-2 (COVID-19) pandemia. Clinical symptoms of the infection appear to be variable, from basically asymptomatic infections and mild, flu-like symptoms up to severe respiratory insufficiency, requiring mechanical ventilation at the intensive care unit, and death. Broad testing for COVID-19 infection has been proven difficult in clinical practice and hampered by limited resources. Urgently needed epidemiological data on the rate of silent, asymptomatic infections in the population and the percentage of individuals that have already developed immunity are still missing. Within this study we therefore plan to (i) determine the proportion of asymptomatic COVID-19 virus carriers in (a) German Cancer Research Center (DKFZ) employees, who work and are present at the center during the time of extended minimum operation and (b) in all DKFZ employees before onboarding when extended minimum operation has been terminated. We plan to (ii) develop a high-throughput assay for COVID-19 testing as well as (iii) a serum-based COVID-19 antibody assay. Finally, we will (iv) analyze for a possible correlation between oral microbiome and COVID-19 infection status.


Eligibility criteria: Inclusion Criteria:

DKFZ employee

Exclusion Criteria:

Non DKFZ employee

Primary outcomes:
measure: COVID-19 infection
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: German Cancer Research Center
state: Baden-Württemberg
Study officials:
References:
Clinical trial NCT02296710: Echocardiographic Parameter and Sleep Apnea Changes After Mitral Valve Surgery
Official title: Echocardiographic Parameter and Sleep Apnea Changes After Mitral Valve Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Keywords: mitral valve
valve surgery
echocardiography
Lead sponsor: Heart and Diabetes Center North-Rhine Westfalia
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators evaluate the changes of echocardiographic and sleep apnea parameters after mitral valve surgery. The patients undergo echocardiographic and sleep apnea control before surgery. After a period of 3-5 months, they undergo a second echocardiographic and sleep apnea control and the results are evaluated.


Eligibility criteria: Inclusion Criteria:

* mitral valve defect
* NYHA II-IV
* no additional cardiac surgical procedure

Exclusion Criteria:

* Pregnancy
* lung disease
* regular follow-up in the study Center in the first 6 months after surgery not guaranteed
* congenital heart disease

Primary outcomes:
measure: Changes of left ventricular systolic function
timeFrame: 1-4 weeks before and 3 months after surgery
measure: Changes of apnea-hypopnea index
timeFrame: 1-4 weeks before and 3 months after surgery
measure: Changes of global longitudinal strain
timeFrame: 1-4 weeks before and 3 months after surgery
measure: Changes of right ventricular systolic function
timeFrame: 1-4 weeks before and 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Heart and Diabetes Center North Rhine-Westphalia
Study officials:
affiliation: Clinic for Cardiology, Heart and Diabetes Center North Rhine-Westphalia
name: Zisis Dimitriadis, MD
role: PRINCIPAL_INVESTIGATOR
References: