louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06431568: Ondansetron Prior Spinal Anaesthesia
Official title: Effect of Prophylactic IV Ondansetron Prior Spinal Anaesthesia in Caesarean Section on Bradycardia and Hypotension (Observational Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section
Keywords: Spinal anesthesia, Cesarean section, Ondansetron
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Kuwait Institute for Medical Specialization
First posted: 2024-05-28
Enrollment: 400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant patients undergoing elective caesarean section with no co-morbidities before or during pregnancy period, e.g. HTN, DM, PET or Eclampsia, will be recruited. Attempt will be made to include all eligible participants

Brief summary: Since Ondansetron is commonly used during cesarean deliveries to treat nausea and vomiting, this study will observe the correlation between ondansetron administration and effect on hemodynamics in order to confirm that the use of Ondansetron can reduce incidence of hypotension and bradycardia associated with spinal in cesarean section, and to identify the optimal timing and dose for administration.

Detailed description: Hypothesis:

Administration of ondansetron prior to spinal anesthesia can attenuate hypotension and bradycardia.

Aim:

Since Ondansetron is commonly used during cesarean deliveries to treat nausea and vomiting, this study will observe the correlation between ondansetron administration and effect on hemodynamics in order to confirm that the use of Ondansetron can reduce incidence of hypotension and bradycardia associated with spinal in cesarean section, and to identify the optimal timing and dose for administration.

Objectives:

* Primary outcome: incidence of hypotension after spinal anaesthesia in the patients who received Ondansetron and those who did not
* Secondary outcome : use of vasopressors , bradycardia , timing of administration of Ondansetron wether it is more or less than five minutes prior to the administration of anesthesia.

Eligibility criteria: Inclusion Criteria:

* Pregnant patients undergoing elective caesarean section

Exclusion Criteria:

* Preeclampsia
* Eclampsia
* Hypertension
* Diabetes

Primary outcomes:
measure: Blood Pressure
timeFrame: one hour
Secondary outcomes:
measure: Heart rate
timeFrame: One hour
measure: Vasopressor
timeFrame: One hour
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university faculty of medicine
Study officials:
affiliation: Assiut University Faculty Of Medicine
name: Abdelrady S Ibrahim, .M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hofhuizen C, Lemson J, Snoeck M, Scheffer GJ. Spinal anesthesia-induced hypotension is caused by a decrease in stroke volume in elderly patients. Local Reg Anesth. 2019 Mar 4;12:19-26. doi: 10.2147/LRA.S193925. eCollection 2019.
Clinical trial NCT01305668: Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Emphysema
Official title: Effectiveness of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Emphysema Phenotype
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Emphysema
Keywords: COPD
Emphysema phenotype
Lead sponsor: Villa Pineta Hospital
Sponsor class: OTHER
First posted: 2011-03-01
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients with or without Emphysema phenotype

Brief summary: Chronic Obstructive Pulmonary Disease has two heterogeneous conditions (chronic bronchitis and pulmonary emphysema phenotypes) with a different clinical presentation.

The phenotype evaluation in COPD patient (trough clinical, functional and radiographic parameters) could influence final results in pharmacologic and non-pharmacologic management of the disease.

The aim of our study is to investigate whether COPD patients with different disease phenotype (chronic bronchitis versus pulmonary emphysema) have a different response to PR.


Eligibility criteria: Inclusion Criteria:

* COPD disease with any functional grade
* Adherence to participate to a pulmonary rehabilitation program

Exclusion Criteria:

* Recent acute exacerbation (4 weeks preceding enrollment)
* Acute severe concomitant cardiovascular diseases
* Concomitant neoplastic diseases
* NO-Adherence to participate to a pulmonary rehabilitation program

Primary outcomes:
measure: Exercise tolerance
timeFrame: [Time Frame: Day 1 and 20 ]
Secondary outcomes:
measure: Dyspnoea
timeFrame: [ Time Frame: Day 1 and 20]
measure: Symptoms on effort
timeFrame: [ Time Frame: Day 1 and 20]
measure: Perceived Quality of life
timeFrame: [ Time Frame: Day 1 and 20]
measure: Global function
timeFrame: [ Time Frame: Day 1 and 20]
Other outcomes:
Locations:
city: Lumezzane
country: Italy
facility: Fondazione Maugeri IRCCS
state: Brescia
city: Pavullo
country: Italy
facility: Villa Pineta Hospital
state: Modena
city: Volterra
country: Italy
facility: Auxilium Vitae Rehabilitation Center
state: Pisa
city: Velletri
country: Italy
facility: Ospedale San Raffaele
state: Roma
city: Naples
country: Italy
facility: Clinic Center
Study officials:
affiliation: Villa Pineta Hospital and University of Modena and Reggio Emilia
name: Enrico M Clini, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02852668: Power Training Versus Strength Training in the Elderly
Official title: Biomechanical Gait Indicators of Elderly Women in Response to Strength Training or Power Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: elderly
strength training
power training
functional capacity
gait biomechanics
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 30
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The inexorable decline in motor skills during aging provides the investigators with an elderly population with various functional limitations. Among these, the ability to walk, being associated with the risk of falling has been studied by several authors. The adoption of strength and power training as an intervention strategy to reduce the negative effects arising from the physiological or pathological process of aging has been widely discussed in these studies. However, the effects of these interventions on biomechanical gait indicators have not been fully debated yet. Therefore, this study aimed to compare the effects of these two training protocols on functional capacities and biomechanical gait parameters of elderly women.

Detailed description: Three female groups, homogenized by age, body mass index and physical activity level, were formed: the control group (GC: n=8, 69±4 years old), the strength training group (GF: n=6, 67±4 years old) and the power training group (GP, n=7, 68±4 years old). No extra activity was induced to GC's routine. Meanwhile, GF and GP underwent 12 weeks of strength and power training, respectively, with three weekly sessions. While GF performed the exercises with moderate speed (70-90% of 1RM), the GP executed them in fast speed (40-60% of 1RM). A kinematic and electromyographic gait evaluation, as well as balance and functional capacity evaluations, were conducted prior and after the intervention period.

Eligibility criteria: Inclusion Criteria:

* sedentary women with no physical mobility limitations

Exclusion Criteria:

* attending less than 75% of the intervention sessions and not attending the final evaluation

Primary outcomes:
measure: Gait kinematics
timeFrame: through study completion, an average of 6 months
measure: Timed up and go test
timeFrame: through study completion, an average of 6 months
measure: Muscle power
timeFrame: through study completion, an average of 6 months
measure: electromyography gait analysis
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Alberto C Amadio, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00568568: Metabolic Studies- Interactions Between GH and Insulin in GHDA
Official title: Metabolic Studies- Interactions Between GH and Insulin in GHDA. Insulin Resistance and GH Treatment: Dependence of Ambient GH Level Among Patients Treated With GH and Healthy Control Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Keywords: Growth Hormone
GH signaling
Insulin resistance
Insulin Signaling
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Novo Nordisk A/S
First posted: 2007-12-06
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose og this study is to investigate the effects of growth hormon on insulin signalling pathways and the temporal association between administration of GH and developing of insulin resistance.

Detailed description: Insulin resistance is a pathophysiological component of type 2 diabetes, obesity and elevated blood pressure. Overall they are syndromes with multifactorial ethology and partly unclarified pathophysiology. Insulin resistance also occur in more seldom diseases with a more unified pathogenesis. Growth hormone deficiency (GHD) in adults with hypopituitarism is an example of one of those seldom diseases. Prolonged GHD is associated with abdominal overweight, dyslipidemia and increased cardiovascular morbidity. Besides, GHD-patients have decreased insulin sensitivity presumably secondary to the altered body composition. Long term effects of GH-substitution improves insulin sensitivity but it is well-known that subcutaneous administration of GH acute worsen insulin sensitivity in both muscles- and liver-tissue. Recently it has been reported that insulin resistance in patients with type 2 diabetes is associated with the induction of a signal protein called suppressor of cytokine signalling (SOCS). It´s interesting that GH also induces a stimulation of SOCS.

Eligibility criteria: Inclusion Criteria:

* Written consent before study start
* Growth Hormone substitution in stable dosis for at least 3 months prior to study start
* Other substitution in stable dosis for at least 3 months prior to study start

Exclusion Criteria:

* Medical treatment for diabetes
* Hypertension even with medical treatment
* BMI \> 30
* Excessive alcohol abuse

Primary outcomes:
measure: Socs 1-3 activity in muscle tissue and degree of insulin resistance
timeFrame: 6 hours
Secondary outcomes:
measure: Growth Hormone Signaling Proteins in Muscle Tissue and other Insulin Signaling Proteins in Muscle Tissue
timeFrame: 6 hours
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department M (endocrinology and diabets)
Study officials:
affiliation: Depatment M (endocrinology and diabetes), Aarhus University Hospital, Nørrebrogade 44, 8000 Aarhus C, Denmark
name: Jens Otto L Jørgensen, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01369368: Treatment of Acute Leukemia Relapse After Allotransplantation
Official title: Treatment of Relapsed Acute Leukemia After Allogeneic Stem Cell Transplantation: Disease Stabilization Through Chemotherapy, Immunomodulatory Treatment and Immunotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: Acute myeloid leukemia
Allogeneic stem cell transplantation
Relapse
Disease stabilization, survival
Lead sponsor: University of Bergen
Sponsor class: OTHER
First posted: 2011-06-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with relapse of acute leukemia often only receive supportive therapy. Our hypothesis is that a combination therapy can stabilize the disease for patients with early relapse after allogeneic stem cell transplantation. The investigators will combine 5-azacitidine 100 mg daily subcutaneously (days 1-3), valproic acid (continuous therapy from day 1), All-trans retinoic acid (days 1-14) and hydroxurea (continuous treatment from day 15 of first cycle. Azacitidine and ATRA can be repeated with 5 weeks intervals, donor leukocyte infusions on day 10 is allowed from the second cycle.


Eligibility criteria: Inclusion Criteria:

* AML relapse within one year after transplantation
* Blood and marrow sampling being possible
* Expected survival at least 4 weeks
* No expected drug interactions
* Informed consent possible

Exclusion Criteria:

* Intolerance to any study drug
* Serious kidney or liver disease
* Informed consent not possible
* Previous pancreatitis

Primary outcomes:
measure: Disease stabilization
timeFrame: 5 years
Secondary outcomes:
measure: Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
References:
Clinical trial NCT01644968: Phase 1 Study of Anti-OX40 in Patients With Advanced Cancer
Official title: Phase 1 Trial of a Monoclonal Antibody to OX40 in Patients With Advanced Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Keywords: metastatic carcinoma
lymphoma
sarcoma
anti-OX40
Lead sponsor: Providence Health & Services
Sponsor class: OTHER
First posted: 2012-07-19
Enrollment: 30
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: This study is designed to determine the safety and highest tolerated dose of anti-OX40 in patients with advanced cancer.

Detailed description: This study will evaluate the safety and determine the maximal tolerated dose of anti-OX40; evaluated the immune response to the study treatment; measure the pharmacokinetics of anti-OX40; monitor tumor regression, and identify the most biologically active dose of anti-OX40 to induce antigen-specific responses to a variety of immunogens.

Eligibility criteria: Inclusion Criteria:

* Patients with uncurable metastatic carcinoma, lymphoma, or sarcoma.
* ECOG performance status 0, 1, 2
* No active bleeding
* No clinical coagulopathy
* Anticipated lifespan greater than 12 weeks

Exclusion Criteria:

* Active residual toxicity from prior therapies
* Active Infection
* HIV positive
* Hepatitis B or C positive
* Pregnant or nursing women
* Requirement for oral steroids
* Brain metastases
* Presence or history of autoimmune disease
* Shellfish or tetanus allergy
* Splenomegaly
* Lymph nodes greater than 10 cm in maximal diameter
* Uncontrolled angina or class II or IV heart failure

Primary outcomes:
measure: Dose limiting toxicity
timeFrame: 28 Days
Secondary outcomes:
measure: Immune Response
timeFrame: Pre-study, Days 5, 8, 15, 29, 36, 43, and 57.
Other outcomes:
Locations:
city: Portland
country: United States
facility: Providence Cancer Center
state: Oregon
Study officials:
affiliation: Providence Health & Services
name: Brendan Curti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Curti BD, Kovacsovics-Bankowski M, Morris N, Walker E, Chisholm L, Floyd K, Walker J, Gonzalez I, Meeuwsen T, Fox BA, Moudgil T, Miller W, Haley D, Coffey T, Fisher B, Delanty-Miller L, Rymarchyk N, Kelly T, Crocenzi T, Bernstein E, Sanborn R, Urba WJ, Weinberg AD. OX40 is a potent immune-stimulating target in late-stage cancer patients. Cancer Res. 2013 Dec 15;73(24):7189-7198. doi: 10.1158/0008-5472.CAN-12-4174. Epub 2013 Oct 31.
Clinical trial NCT01707368: Non-interventional Study of Long-term Treatment of Psoriasis With Calcipotriol Plus Betamethasone in Gel Formulation
Official title: Course of Psoriasis During Long Term Treatment With Calcipotriol Plus Betamethasone in Gel Formulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis Vulgaris
Plaque Psoriasis
Keywords: Psoriasis
Psoriasis vulgaris
Plaque Psoriasis
Daivobet® Gel
Germany
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2012-10-16
Enrollment: 561
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Psoriasis vulgaris visiting their attending dermatologist in the primary care clinic

Brief summary: The purpose of this observational study is to document the course of disease and relapse management during treatment with Daivobet® Gel under consideration of patient's individual application habits under daily use conditions.


Eligibility criteria: Inclusion Criteria:

* Patients with light to moderate psoriasis vulgaris of trunk and extremities and treatment with Daivobet® Gel was planned anyway.
* Minimum of 3 years diagnosed psoriasis vulgaris.

Exclusion Criteria:

* Previous therapy with Daivobet® Gel
* Systemic therapy of psoriasis vulgaris
* Contraindications of Daivobet® Gel in the German package insert
* people that are incapable to give free consent

Primary outcomes:
measure: The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient's Individual Application Habits Under Daily Use Conditions.
timeFrame: 1 year
Secondary outcomes:
measure: PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)
timeFrame: Baseline
measure: PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)
timeFrame: 1 year
measure: Side Effects
timeFrame: 1 year
Other outcomes:
Locations:
city: Osnabrück
country: Germany
facility: PD Dr. med. Rosenbach
state: Niedersachsen
Study officials:
affiliation: private practise, D- 49078 Osnabrück, Germany
name: Thomas Rosenberg, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04359368: Characteristics of Patients With Hypersensitivity Reactions to Intravenous Iron Infusions
Official title: Characteristics of Patients With Hypersensitivity Reactions to Intravenous Iron Infusions - a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron-deficiency
Hypersensitivity Reactions
Keywords: complement activation-related pseudoallergy (CARPA)
Hypersensitivity reactions (HSR)
iron-deficiency
non dextran iron preparations (NDIPs)
anemia
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 42
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants from 16 years of age and older with previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject) or to iron sucrose (Venofer).

Brief summary: This study aims to evaluate characteristics of patients with previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject) or to iron sucrose (Venofer) including age, atopy status, previous allergic reactions, previous medical history, current medications and co-morbidities. Furthermore, symptoms on reaction such as severity grade of reaction will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Participants from 16 years of age and older with previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject) or to iron sucrose (Venofer).

Exclusion Criteria:

* No previous hypersensitivity reaction to iron preparations or reactions to oral iron preparations.
* If a rejection to use patient data is documented in patient records, the patient will be excluded from analysis.

Primary outcomes:
measure: previous medical history
timeFrame: Baseline; Patients with HSRs to NDIPs that were treated at the University Hospital Basel between the 16th of January 2018 and the 24th of October 2019
measure: Family history
timeFrame: Baseline; Patients with HSRs to NDIPs that were treated at the University Hospital Basel between the 16th of January 2018 and the 24th of October 2019
measure: assessment of hypersensitivity reactions
timeFrame: Baseline; Patients with HSRs to NDIPs that were treated at the University Hospital Basel between the 16th of January 2018 and the 24th of October 2019
measure: preparation used
timeFrame: Baseline; Patients with HSRs to NDIPs that were treated at the University Hospital Basel between the 16th of January 2018 and the 24th of October 2019
measure: co-medication
timeFrame: Baseline; Patients with HSRs to NDIPs that were treated at the University Hospital Basel between the 16th of January 2018 and the 24th of October 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: Allergology, University Hospital Basel
name: Esther Steveling-Klein, Dr. med
role: PRINCIPAL_INVESTIGATOR
References: