louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03234413: Safety on Switching Between Different Botulinum Toxin-A
Official title: Switching Between Different Types of Botulinum Toxin-A in Children With Cerebral Palsy Treated for Spasticity: a Safety Retrospective Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: Botulinum Toxin-A
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2017-07-31
Enrollment: 118
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: No active study treatment will be given as this will be a retrospective study. Information on children with at least two subsequent injection of two different types of toxinA for the treatment of spasticity will be collected and analysed

Brief summary: Clinical guidelines recommend the use of Botulinum Toxin-A (BoNT-A) for localized/segmental spasticity in children with cerebral palsy. At the Kocaeli University (KOU) Department of Physical Medicine and Rehabilitation (PMR) more than 800 patients have been injected with the two approved toxinA types; OnabotulinumtoxinA or AbobotulinumtoxinA.

With this study investigators would like to evaluate retrospectively if switching from one toxin to another is safe as well as to evaluate if the efficacy when switching from one toxin to another was maintained.

Detailed description: A data base was designed to capture all data that were considered relevant to the treatment evaluation. The data were transcribed directly from participants medical records. For the purpose of the study, data from the two subsequent visits where a different type of toxin was given will be collected and evaluated . In order to collect the pre and post status in terms of safety and efficacy, for each participant, data corresponding to the 6 previous and posterior months after the switch of the toxin will also be collected or data corresponding to the previous and posterior visit after the switch of the toxin will also be collected.

Eligibility criteria: Inclusion Criteria:

* children diagnosis of cerebral palsy with respect to Rosenbaum criteria,
* children having received repeated injections with two different types of toxinA treatment into their lower limb(s)

Exclusion Criteria:

* children without repeated Botulinum toxin type A injections
* children having received repeated injections with same type of toxinA

Primary outcomes:
measure: Occurence of treatment related adverse events
timeFrame: Up to 30 months
Secondary outcomes:
measure: Modified Ashworth Scale
timeFrame: Up to 30 months
measure: Tardieu Scale
timeFrame: Up to 30 months
measure: Observational Gait Scale
timeFrame: Up to 30 months
Other outcomes:
measure: Goal Attainment Scale
timeFrame: Up to 30 months
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
affiliation: Kocaeli University
name: Nigar Dursun, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06357013: Postoperative Analgesia in Bilateral Knee Arthroplasties
Official title: Postoperative Analgesia in Bilateral Knee Arthroplasties:Suprainguinal Fascia Iliaca Compartment Block and Local Infiltration Analgesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Arthroplasty, Total
Peripheral Nerve Block
Pain, Postoperative
Keywords: pain
pain management
nerve block
Lead sponsor: Kocaeli City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18-75 years, who planned elective bilateral knee arthroplasty under spinal anesthesia, American Society of Anesthesiologists (ASA) risk score I-II.

Brief summary: To observationally compare the analgesic efficacy of LIA and S-FICB techniques and to record the pain scores of patients who underwent bilateral knee operations in the postoperative period.


Eligibility criteria: Inclusion Criteria:

* Planned elective bilateral knee arthroplasty under spinal anesthesia
* American Society of Anesthesiologists (ASA) risk score I-II
* Patients aged 18-75 years

Exclusion Criteria:

* Those receiving general anesthesia,
* Those with epidural catheters,
* Those who refused to participate in the study,
* Those whose spinal anesthesia failed and returned to general anesthesia,
* Those with a body mass index (BMI) \>30 kg/m2,
* History of chronic opioid or corticosteroid use,
* Patients with psychiatric or neurological problems that would not allow assessment of pain using a visual analog scale (VAS) will be excluded.
* In addition, patients whose surgery lasted \<40 minutes or \>120 minutes will also be excluded to keep the data homogeneous.

Primary outcomes:
measure: Suprainguinal fascia iliaca compartment block (S-FICB) produces adequate analgesic effect in knee arthroplasty.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli City Hospital
Study officials:
affiliation: Kocaeli City Hospital
name: Merve Yazici Kara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01080313: Head and Neck Cancer Registry (LORHAN)
Official title: Prospective, Longitudinal, Multi-Center, Descriptive Registry of Patients Receiving Therapy Other Than Surgical Resection Alone for Newly Diagnosed Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-03-04
Enrollment: 26000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The primary objective of this study is to describe, in detail, patterns of care for head and neck carcinoma patient


Eligibility criteria: Inclusion Criteria:

* Pathologically (histologically or cytologically) confirmed new diagnosis of carcinoma involving the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, or neck node metastasis from unknown origin
* Scheduled to receive radiotherapy and/or drug therapy including chemotherapy, biologic therapy and targeted therapy
* Written informed consent

Exclusion Criteria:

* Registry participation does not exclude participation in clinical trials.
* Patients scheduled to receive or who have received surgery are eligible for Registry participation as long as they are also scheduled to receive medical therapy.

Primary outcomes:
measure: Patterns of care for head and neck cancer
timeFrame: up to 10 years
Secondary outcomes:
measure: Overall survival by treatment regimen
timeFrame: study entry to death from any cause or to end of study
measure: Determine the incidence and severity of major dose-limiting and other important treatment toxicities
timeFrame: up to 10 years
measure: Identify supportive care received for managing nutrition, pain, nausea and other complications
timeFrame: up to 10 years
measure: tumor control by treatment regimen
timeFrame: study entry to progressive disease
Other outcomes:
Locations:
city: Minnetonka
country: United States
facility: Mednet Solutions
state: Minnesota
Study officials:
affiliation: MedNet Solutions
name: Mednet Solutions
role: STUDY_DIRECTOR
References:
Clinical trial NCT04715113: Blood Markers Predict Effect of Normobaric Hypoxia at Rest and During Exercise in Patients With Pulmonary Hypertension
Official title: Hemodynamic Effects of Acute Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension: Single-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension, Pulmonary
Keywords: hypoxia
exercise
blood markers
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To study the effect of acute normobaric hypoxia during exercise in patients with pulmonary hypertension on blood markers (serum markers of iron and red blood cell homeostasis and micro-RNAs known to be associated with PH).


Eligibility criteria: Inclusion Criteria:

* Informed consent as documented by signature (Appendix Informed Consent Form)
* PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure \>20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization

Exclusion Criteria:

* resting partial pressure of oxygen \<8 kilopascal at Zürich altitude on ambient air
* exposure to an altitude \>1000 m for ≥3 nights during the last 2 weeks before the study
* inability to follow the procedures of the study
* patients who take nitrates
* other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)

Primary outcomes:
measure: Serum levels of ferritin
timeFrame: Baseline
Secondary outcomes:
measure: Serum levels of transferrin
timeFrame: Baseline
measure: Serum levels of total iron
timeFrame: Baseline
measure: Serum levels of erythropoietin
timeFrame: Baseline
measure: Serum levels of Erythroferrone
timeFrame: Baseline
measure: Serum levels of hepcidin
timeFrame: Baseline
measure: micro-RNA levels
timeFrame: Baseline
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Zurich
Study officials:
affiliation: UniversityHospital Zurich, Department of Pulmonology
name: Silvia Ulrich, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00491413: Erythropoietin for Infants With Brain Injuries Due to Oxygen Deprivation at Birth
Official title: High Dose Erythropoietin for Neonates With Asphyxia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Asphyxia
Keywords: neurodevelopmental outcomes
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2007-06-26
Enrollment: 15
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Erythropoietin (Epo) is a hormone normally found in the body that may protect brain cells from damage due to lack of oxygen. This study will evaluate the safety of high-dose Epo in infants who did not get enough oxygen during birth.

Detailed description: Damage to the central nervous system as a result of oxygen deprivation at birth is a major cause of life-long mental and developmental handicaps. When there is not enough oxygen in the blood (hypoxemia) the brain is deprived of oxygen. Some brain cells respond by producing Epo. Epo then binds to oxygen-deprived brain cells. This binding triggers chemical reactions within the brain cell that prevent cell death. Epo also reduces inflammation around the brain cells and acts as an antioxidant. In animal studies, recombinant Epo (rEpo) administration, even up to six hours after oxygen deprivation, reduced subsequent brain injury by 50% to 70%.

Epo has been used by neonatologists to stimulate erythropoiesis (red blood cell production) and reduce the incidence of blood transfusions. Doses of rEpo required for protection of brain cells are considerably higher than those traditionally used by neonatologists.

This study will evaluate the pharmacokinetics, biologic effect, and safety of high dose Epo in neonates with brain injury due to hypoxemia.

Within six hours of birth, each eligible infant will receive one dose of rEpo intravenously. Any infants who require a lumbar puncture during the first week of life will have levels of natural Epo and rEpo in their spinal fluid measured. Blood tests will be used to measure the antioxidant effect of Epo and the impact on red blood cell production. Neurodevelopmental outcome will be measured at 6 and 12 months of age.

Eligibility criteria: Inclusion Criteria

* Infant 6 hours of age or less
* Apgar scores less than or equal to 3 at 1 and 5 minutes
* Weight greater than 2500 grams (5.5 lbs)
* Central venous line in place

Exclusion Criteria

* infants are ineligible if they do not meet the inclusion criteria above

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Petersburg
country: United States
facility: All Children's Hospital
state: Florida
Study officials:
affiliation: University of South Florida
name: Robert D. Christensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00746213: Chronic Pain After Thoracotomy, an Incidence Study
Official title: Chronic Pain After Thoracotomy, an Incidence Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracotomy
Chronic Pain
Keywords: Thoracotomy
Chronic Pain
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Lung Cancer Group
name: Aarhus University Hospital
First posted: 2008-09-03
Enrollment: 1340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post thoracotomy patients after lung cancer in Denmark

Brief summary: This is an investigation on the frequency of chronic pain after thoracotomy for lung cancer. Factors relating to the development of chronic pain are investigated. Questionnaire survey.


Eligibility criteria: Inclusion Criteria:

* Able to understand and give consent
* Can read
* Residing in Denmark

Exclusion Criteria:

* Unable to understand the written information in Danish
* Abuse (Medicine, Drugs, Alcohol)
* Severe psychiatric Illness
* Conflicting neurological disease

Primary outcomes:
measure: Pain and pain score
timeFrame: more than 6 months postoperative
Secondary outcomes:
measure: Activity of daily life
timeFrame: >6 months
measure: Analgesic consumption and pain treatment
timeFrame: >6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Section for Surgical Pathophysiology 4074
Study officials:
affiliation: Section for Surgical Pathophysiology 4074
name: Henrik Kehlet, MD.Phd,Proff
role: STUDY_CHAIR
References:
Clinical trial NCT05738213: Puberty, Sex Hormones and Pain Sensitivity in Adolescents With Migraine
Official title: Hormonal Effects of Puberty-Related Alterations on Pain in Adolescents With Migraine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine
Keywords: pain
puberty
sex hormones
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: International Headache Society
First posted: 2023-02-21
Enrollment: 100
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this research study is to investigate the relationships between sex hormone levels and experimental pain sensitivity and migraine severity will be examined.

Detailed description: This study will investigate how puberty and variability in sex hormone levels impact pain sensitivity and migraine symptoms.

Hypothesis 1- A significant reduction in pain sensitivity from early to late pubertal status will be found only for adolescents without but not with migraine during pubertal maturation.

Hypothesis 2- Experimental pain sensitivity will be negatively correlated with testosterone levels in adolescents in both groups (with and without migraine).

Exploratory Hypothesis 1- In adolescents with migraine, higher migraine severity (headache frequency and migraine disability) will be associated with lower testosterone levels.

Exploratory hypothesis 2- Adolescents with migraine will have lower testosterone levels than those without.

Eligibility criteria: Inclusion criteria

1. Age between 11-15
2. Males and females
3. English speakers
4. Migraine group: diagnosed with migraine
5. Control group: Healthy, with no first degree relative with migraine

Exclusion criteria:

1. Pregnancy or breastfeeding,
2. Chronic pain (except for migraine for the migraine group), neurological or psychiatric syndromes or syndromes associated with pubertal maturation
3. Use of medications that impact sex hormone levels (i.e., contraceptive pills)

Primary outcomes:
measure: Conditioned pain modulation (CPM) response
timeFrame: Baseline
measure: Sex Hormones
timeFrame: Baseline
Secondary outcomes:
measure: Sex hormone assessments
timeFrame: Baseline
measure: Migraine specific measures
timeFrame: Baseline
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Hadas Nahman-Averbuch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02629913: Is Internet-based Self-help Effective for the Treatment of Insomnia Disorder?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Disorder
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-12-14
Enrollment: 56
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: The Swiss company mementor has recently developed an interactive self-help intervention for the treatment of insomnia entitled mementor somnium. This programme is based on the guidelines for cognitive-behavioural therapy. mementor somnium consists of 6 online sessions. An animated personal sleep coach provides relevant audio-information and asks questions to which the patient is invited to respond. The components of the programme flexibly adapt to the patient's responses. Aside from psycho-education, exercises and an instruction for sleep restriction, mementor somnium includes a cognitive restructuring intervention in terms of a Socratic dialogue. This Socratic dialogue, implemented by the animated sleep coach, is based on a complex algorithm in the shape of an decision tree. University of Zurich's Department of Psychology in Switzerland will test the effectiveness of mementor somnium in a randomised controlled trial with three assessment times (pre, 6-weeks post and 3-months follow-up). Patients suffering from insomnia will be allocated randomly to either the active intervention group or the waitlist control group. Participants will have access to the programme mementor somnium for six weeks. Primary outcome measure is the Insomnia Severity Index, secondary outcome measures are Beck Depressions-Inventory revised (BDI-II), Brief Symptom Inventory 18, and the SF-12 Health Survey. Additionally, sleep diary data will be collected.


Eligibility criteria: Inclusion Criteria:

* Insomnia Disorder (DSM-5)
* German language comprehension
* Internet-access

Exclusion Criteria:

* Other sleep disorder
* Suicidality
* Current psychotherapy
* Drug abuse or recent change in medication

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: Six weeks
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: Six weeks
measure: Brief Symptom Inventory 18
timeFrame: Six weeks
measure: SF-12 Health Survey
timeFrame: Six weeks
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich
Study officials:
References:
Clinical trial NCT00542113: Diabetes Virtual Trek: Obesity and Diabetes Prevention Through Science Enrichment
Official title: Diabetes Virtual Trek Prevention: Obesity and Diabetes Prevention Through Science Enrichment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Obesity
Keywords: Parental
Parents
Prevention
Energy balance
Glucose regulation
Healthy lifestyles
Healthy families
Active living
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: Poudre School District, Fort Collins, CO
name: Montezuma-Cortez School District, Cortez, CO
First posted: 2007-10-10
Enrollment: 1703
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to evaluate the effectiveness of a school-to-home education program for it's ability to increase knowledge about, and ability to prevent type two diabetes in children and parents.

Detailed description: The study involved pre and post testing of parent's knowledge and behaviors relating to the prevention of type two diabetes, before and after a school based intervention designed to encourage school to home communication. Parents/Guardians and children, grades 2-6, from schools with high Hispanic enrollment during the 2001-2005 school year were used for both comparison and intervention groups.

Eligibility criteria: Inclusion Criteria:

* Elementary school children in grade 2-6 in intervention or comparison classes/schools

Primary outcomes:
measure: Diabetes knowledge and prevention of parents of elementary school children
timeFrame: one-three school year(s)
Secondary outcomes:
measure: Self-reported parental physical activity
timeFrame: one -three school year(s)
Other outcomes:
Locations:
city: Cortez
country: United States
facility: Montezuma-Cortez School District
state: Colorado
city: Fort Collins
country: United States
facility: Putnam, Tavelli, Bennett and Dunn Elementary Schools
state: Colorado
Study officials:
affiliation: Colorado State University
name: L. Arthur Campfield, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01693913: Cognitive-behavioral Weight Loss Treatment
Official title: Effects of a Cognitive-behavioral Weight Loss Treatment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Weight
Lead sponsor: YMCA of Metropolitan Atlanta
Sponsor class: OTHER
First posted: 2012-09-26
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: That a treatment using a cognitive-behavioral treatment for exercise and nutrition support will be associated with greater weight loss that a treatment of nutrition and exercise education.


Eligibility criteria: Inclusion Criteria:

* Female
* Ages 21-60
* Body mass index 30-40 kg/m2

Exclusion Criteria:

* Pregnancy
* Medications for a psychological disorder
* Contraindications for exercise

Primary outcomes:
measure: weight
timeFrame: baseline, months 3,6,12, 24
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: YMCA of Metro Atlanta
state: Georgia
Study officials:
affiliation: YMCA of Metro Atlanta
name: James J Annesi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Annesi JJ. Supported exercise improves controlled eating and weight through its effects on psychosocial factors: extending a systematic research program toward treatment development. Perm J. 2012 Winter;16(1):7-18. doi: 10.7812/11-136.
citation: Annesi JJ, Marti CN. Path analysis of exercise treatment-induced changes in psychological factors leading to weight loss. Psychol Health. 2011 Aug;26(8):1081-98. doi: 10.1080/08870446.2010.534167. Epub 2011 Jul 25.
citation: Annesi JJ, Unruh JL, Marti CN, Gorjala S, Tennant G. Effects of the coach approach intervention on adherence to exercise in obese women: assessing mediation of social cognitive theory factors. Res Q Exerc Sport. 2011 Mar;82(1):99-108. doi: 10.1080/02701367.2011.10599726.