louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02699502: Metabolic Therapy in Patients With Osteoporosis After Hip Fracture by an Orthopedic-rehabilitation-metabolic Team
Official title: Metabolic Therapy in Patients With Osteoporosis After Hip Fracture by Cooperation Orthopedic-rehabilitation-metabolic: Determination of Drug Treatment Regardless of Reaching the Follow-up Clinic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Fracture
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Metabolic therapy in patients with osteoporosis after hip fracture by cooperation orthopedic-rehabilitation-metabolic: Determination of drug treatment regardless of reaching the follow-up clinic

Detailed description: Osteoporotic hip fractures are a significant cause of morbidity and mortality in older age. Patients with this fracture are at high risk of further fracture, it can be reduced by appropriate metabolic therapy. However, only 30% of patients after a hip fracture receive basic treatment appropriate calcium and vitamin D, only 10-15% receive complementary metabolic therapy more drugs prevent bone resorption, or bone-building drugs as recommended in the literature, the prevention of further fractures. studies conducted in the past have proven, multi-disciplinary team of dedicated financial institution may increase appropriate treatment and improve the quality of care in these patients.

Previous data in our institution has shown that 84% of patients with hip fractures received calcium and vitamin D during hospitalization, but only 47% of the patients came to the metabolic clinic. Moreover, of the patients who came to the metabolic clinic, only 46% were put on complementary metabolic therapy, mostly due to a lack of sufficient vitamin D level. In the present study investigators attempt to treat patients without physical attendance at the metabolic clinic.

Eligibility criteria: Inclusion Criteria:

* All patients were analyzed could Department of Orthopedics with a hip fracture

Exclusion Criteria:

-

Primary outcomes:
measure: The number of patients with hip fracture that will receive anti osteoporosis therapy without attending the metabolic clinic in comparison to previous results in the study mentioned above (No. Helsinki 0072-14-MMC)
timeFrame: half a year
Secondary outcomes:
measure: Number of drugs that will be approved by the regulatory authorities
timeFrame: half a year
measure: Number of drugs that will be prescribed by family physicians
timeFrame: half a year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00265902: Infrared Thermography in Finding Skin Lesions in Patients With Kaposi's Sarcoma
Official title: Ultra-Sensitive, Infra-Red Thermographic Analysis of Kaposi's Sarcoma Skin Lesions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sarcoma
Keywords: Kaposi sarcoma
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-12-15
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: RATIONALE: Diagnostic procedures, such as infrared thermography, may help find Kaposi's sarcoma and learn the extent of disease.

PURPOSE: This clinical trial is studying how well infrared thermography finds skin lesions in patients with Kaposi's sarcoma.

Detailed description: OBJECTIVES:

Primary

* Compare ultra-sensitive infrared thermographic images with visible light digital photographic images and clinical dermatologic examination as methods of measuring cutaneous lesions in patients with Kaposi's sarcoma (KS).

Secondary

* Compare differences in modulation of temperature detected in KS skin lesions with non-involved skin of the same patient and with normal skin of healthy volunteers by sequential imaging using the infrared thermographic camera.

OUTLINE: This is a controlled, pilot study.

Patients undergo clinical assessment followed by simultaneous digital photographic camera imaging and high-resolution infrared thermographic camera imaging of designated normal skin areas and selected marker lesions. Before imaging, a metal bar chilled to 0º C, 10º C, and 25º C is applied to the lesions and designated normal skin areas for up to 90 seconds.

Healthy volunteers (controls) undergo the same procedure as for the patient except only designated normal skin areas are used.

PROJECTED ACCRUAL: A total of 20 patients and 10 healthy volunteers (controls) will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Histologically confirmed cutaneous Kaposi's sarcoma (KS)

    * At least one skin lesion accessible for imaging
    * HIV positivity with proven cutaneous KS and concurrent visceral or mucous membrane involvement allowed
  * Healthy volunteer (regardless of HIV status) (control)

PATIENT CHARACTERISTICS:

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Pregnancy allowed

PRIOR CONCURRENT THERAPY:

* Prior topical, intralesional, or systemic treatment allowed

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Ciro Martins, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00624702: Tolerability of Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma
Official title: A Multi-center, Randomized, Single-dose, Double-blind, 4-way Cross-over Study to Evaluate Tolerability Following Treatment With Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: Asthma, cough, spirometry, maleate, xinafoate, acetate, SDDPI (single dose dry powder inhaler)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-02-27
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will explore information on whether changing the salt formulation of indacaterol affects the incidence of post-inhalation cough.


Eligibility criteria: Inclusion Criteria:

* Male and female patients 18 to 65 years old (inclusive)
* Patients with mild to moderate persistent asthma
* BMI must be within the range of 18-32 kg/m2 inclusive
* Female subjects must:

  1. have been sterilized at least 6 months prior to screening
  2. be post-menopausal with no regular bleeding for at least a year prior to inclusion

Exclusion Criteria:

* Patients with life-threatening arrhythmias
* Patients with COPD or diabetes mellitus
* History of immunocompromise, including a positive HIV
* A positive Hepatitis B surface antigen (HBsAg) of Hepatitis C test result

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation)
timeFrame: throughout the study
measure: Severity of cough: to be judged independently by both the patient and the physician
timeFrame: throughout the study
measure: Occurrence of cough within 1 minute post dose
timeFrame: throughout the study
measure: Number of coughs
timeFrame: throughout the study
measure: Duration of coughing
timeFrame: throughout the study
Secondary outcomes:
measure: Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation)
timeFrame: throughout the study
measure: Severity of cough: to be judged independently by both the patient and the physician
timeFrame: throughout the study
measure: Occurrence of cough within 1 minute post dose
timeFrame: throughout the study
measure: Number of coughs
timeFrame: throughout the study
measure: Duration of coughing
timeFrame: throughout the study
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Novartis Investigator Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigator Site
state: Quebec
Study officials:
affiliation: Novartis investigator site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03151902: Detection of Viral Particels in Urticaria Patients
Official title: Detection of Viral Particels in Urticaria Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urticaria Chronic
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with chronic spontaneous urticaria

Brief summary: Blood samples from urticaria patients will be analyzed for viral particles

Detailed description: After digestion with DNase to eliminate human DNA, RNA will be reversed-transcribed and amplified with random primer/ Amplification products will be pooled and sequenced/ After substruction of sequences of vertebrates and highly repetitive sequences, contiguous sequences will be assembled and compared with motifs represented in databases of viruses. which will enable identification of putative protein sequences consistent with viruses

Eligibility criteria: Inclusion Criteria:

* Patients with chronic spontaneous urticaria

Exclusion Criteria:

* none

Primary outcomes:
measure: viral particles
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Emek Medical Center
Study officials:
affiliation: haemek medical center
name: Menachem Rottem
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03544502: Is Music the Food of Anesthesia in Children?
Official title: Is Music the Food of Anesthesia in Children?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Music
Keywords: music, anesthesia, surgery
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 105
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The patients were randomly separated into three groups. Group M (n=35) applied CD player and Group S (n=35) received the independent anesthesiologist placed earplugs into the patients' ears. Group N (n=35) exposed to the ambient operating room noise.

Detailed description: Hundred and five pediatric patients who scheduled for abdominal surgery in ASA I-II risk groups were enrolled in the study. The patients were randomly separated into three groups. Group M (n=35) applied CD player and Group S (n=35) received the independent anesthesiologist placed earplugs into the patients' ears. Group N (n=35) exposed to the ambient operating room noise. The preoperative children's anxiety levels were assessed with the M-YPAS in the operating room. Heart rate (HR) and mid-arterial pressure (MAP) were recorded at 30-minute intervals until the completion of surgery, end of surgery and postoperative. During each measurement, noise level recordings were performed using sonometre. Pediatric Anesthesia Emergence Delirium Score (PEAD) was assessed after extubation, postoperative.

Eligibility criteria: Inclusion Criteria:

* scheduled for elective abdominal surgery with an expected operation time of 60 to 120 minutes, were enrolled in the study.

Exclusion Criteria:

* Children were excluded from the study if they had cognitive disorders, with clinically evident hearing impairment, chronic illness, undergoing emergency surgery, and unstable medical conditions requiring intensive care unit admission.

Primary outcomes:
measure: Postoperatively, Emergence delirium (ED) was assessed as a Pediatric Anesthesia Emergence Delirium
timeFrame: 15 minutes in postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01068002: Cardiovascular an Echocardiographic Assessment in Hypertension During Pregnancy
Official title: Hypertension During Pregnancy: Cardiovascular & Echocardiographic Assessment: CREATION - P (01)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: Hypertension Pregnancy
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2010-02-12
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant Women

Brief summary: Cardiovascular \& echocardiographic assessment in pregnant women with hypertension during their pregnancy in comparison to Pregnant normotensive women.

Detailed description: Cardiovascular \& echocardiographic assessment in pregnant women with hypertension during their pregnancy in comparison to Pregnant normotensive women. Also,comparing echocardiographic parameters in hypertensive pregnant women being treated with either alfa methyl dopa or labetolol.

Eligibility criteria: Inclusion Criteria:

* hypertension during pregnancy: Chronic or pregnancy induced

Exclusion Criteria:

* Inability to sign informed consent

Primary outcomes:
measure: Hypertension impact on cardiovascular echocardiographic parameters and obstetric parameters in pregnant women with or without treatment
timeFrame: 1 year
Secondary outcomes:
measure: Primary outcome, Impact of alfa methyl dopa and labetolol on cardiovascular parameters in pregnant women
timeFrame: 1 Year
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Ha'Emek Medical Center
Study officials:
affiliation: Heart Institute, Ha'Emek Medical Center
name: Limor I Bushari
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01848002: Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers
Official title: A Randomized, Placebo-Controlled, Double-Blind, Multi-dose Study of the Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Congenital Bleeding Disorder
Congenital FXIII Deficiency
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-05-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial was conducted in Europe. The aim of this trial was to investigate safety and pharmacokinetics of multiple doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Normal platelet count and clotting parameters
* Adequate renal and hepatic function
* Negative serum pregnancy test within 21 days prior to enrollment and negative urine pregnancy test on admission to the clinical research unit (if subject female and of child-bearing potential)
* Agreement to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits (if subject a sexually active male or female of childbearing potential)
* Negative drug and negative alcohol screens

Exclusion Criteria:

* Known antibodies or hypersensitivity to FXIII
* Known bleeding or hematologic disorder
* Known allergy to yeast
* Receipt of blood products within 30 days of screening
* Donation of blood within 30 days prior to enrollment
* Surgical procedure of any type within 30 days prior to enrollment
* History of autoimmune disorders involving autoantibodies, e.g., systemic lupus erythematosus
* Treatment with any experimental agent within 30 days of study enrollment

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Days 0-33
Secondary outcomes:
measure: Incidence of clinically significant changes from baseline in physical examination or laboratory measurements
timeFrame: From days -1 through day 33
measure: Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay)
timeFrame: From days -1 through day 33
measure: Incidence of yeast antibodies
timeFrame: From days -1 through day 33
Other outcomes:
Locations:
city: Berkshire
country: United Kingdom
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06318702: The Effect of Constructivist Learning Model Based Gynecological Cancer Education
Official title: The Effect of Constructivist Learning Model Based Gynecological Cancer Education on Gynecologic Cancer Awareness, Spiritual Well-being and Health Anxiety: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Cancer
Lead sponsor: Kastamonu University
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 107
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This is a randomised controlled study.The study was conducted to determine the effect of the constructivist education model given to women on gynecological cancer awareness, health Anxiety and spiritual well-being in women . The study population was composed of women living in Kastamonu. Women will be assigned to control and experimental groups. Women in the control group will receive gynecological education from Cancer Early Diagnosis, Screening and Education Centers (KETEM). The other group will receive gynecological cancer education based on the constructivist model.The hypotheses of the study are as follows:

H0: The of constructivist learning model -based health education programme does not have an effect on gynecologic cancer awareness, spiritual well-being and health anxiety.

H1: The of constructivist learning model -based health education programme have an effect on gynecologic cancer awareness, spiritual well-being and health anxiety.


Eligibility criteria: Inclusion Criteria:

* being 18 years old,
* being willing to participate in this study

Exclusion Criteria:

* having any neuropsychiatric disorder,
* having any physical or mental illness,
* being diagnosed with gynecological cancer,
* not attending theoretical trainings.

Primary outcomes:
measure: gynecologic cancer awareness
timeFrame: before education, after education, 4 weeks after education
measure: spiritual well-being
timeFrame: before education, after education, 4 weeks after education
measure: health anxiety scores
timeFrame: before education, after education, 4 weeks after education
Secondary outcomes:
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Kastamonu University
state: Kastamonu
Study officials:
References:
Clinical trial NCT00805402: Interest of Flow Cytometry for the Diagnosis, the Follow up and Specific Immunotherapy (SIT) Arrest of Hymenoptera Venom Allergy
Official title: Interest of Flow Cytometry for the Diagnosis, the Follow up and SIT Arrest of Hymenoptera Venom Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergy
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2008-12-09
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to show that flow cytometry can be an accurate tool to help physicians regarding the diagnosis, the SIT decision and the SIT arrest of hymenoptera venom allergy.

75 patients having a story of reaction to hymenoptera venom will be selected for this trial.

Blood samples will be analyzed at: inclusion visit, Week 1 visit, Week 3 visit, Week 10 and Week 21 visit.


Eligibility criteria: Inclusion Criteria:

* Adult patient (18 - 70 years)
* Patient being informed and accepting to participate in the study with signature of informed consent
* Patients having a clinical systematic and local, loco-regional story of reaction to the piqures of hymenopterans.
* Patients treated by SIT for at least 5 years
* Patients benefiting from a national insurance health

Exclusion Criteria:

* Children
* Pregnant woman or who breast-feed
* Patient under antihistaminic or corticoid for less than 8 days before the blood drawing
* Protected Patient
* Patient not having given his agreement after it was informed

Primary outcomes:
measure: % CD63 expression on basophil membrane by flow Cytometry
timeFrame: Inclusion , Week 1, Week 3, Week 10 and Week 21 visits
Secondary outcomes:
measure: Blood blocking factors level
timeFrame: Week 1, Week 3, Week 10 and Week 21 visits
Other outcomes:
Locations:
city: Limoges
country: France
facility: Service Pathologie Respiratoire
Study officials:
affiliation: CHU Limoges
name: Michel COGNE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Limoges
name: Jean Sainte-Laudy, PhD
role: STUDY_CHAIR
References: