louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04754399: Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias
Official title: Phase 2 Trial of Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthralgia
Breast Cancer
Keywords: Cannabidiol
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: American Society of Clinical Oncology
First posted: 2021-02-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Study of Cannabidol to examine the safety and efficacy of 15 weeks of CBD in postmenopausal women with aromatase inhibitor-associated musculoskeletal symptoms (AIMSS). Investigators are looking to see if patients with joint pain see improvement with the use of CBD.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal according to standard clinical criteria OR receiving concomitant LHRH agonist therapy.
* Taking aromatase inhibitor therapy (anastrozole, exemestane, or letrozole) for adjuvant treatment of breast cancer or for chemoprevention for at least 3 weeks and no more than 2 years at the time of enrollment.
* Planning to take the same AI therapy for at least 15 weeks.
* New or worsening joint pain and/or myalgias since starting the AI therapy.
* Completion of surgery (mastectomy or lumpectomy/partial mastectomy) for treatment of breast cancer at least 3 months prior to enrollment.
* The complete list of inclusion criteria is provided in the protocol.

Exclusion Criteria:

* Metastatic breast cancer.
* Planned surgery during the 15-week study period.
* Clinically significant laboratory abnormalities.
* Use of cannabidiol, THC, or marijuana (oral, inhaled, or topical) within the 6 weeks prior to enrollment.
* History of or currently has suicidal ideation or attempted suicide.
* History of seizure other than febrile seizures in childhood.
* The complete list of exclusion criteria is provided in the protocol.

Primary outcomes:
measure: Absolute Change in Brief Pain Inventory (BPI) Worst Pain From Baseline to Week 15
timeFrame: Baseline, week 15
Secondary outcomes:
measure: Number of Patients With at Least a 2-point Reduction in BPI Worst Pain From Baseline to Week 15
timeFrame: Baseline, week 15
measure: Number of Patients With at Least a 2-point Reduction in BPI Average Pain From Baseline to Week 15
timeFrame: Baseline, week 15
measure: Change in Symptoms From Baseline, as Measured by the PROMIS-29+2 Profile v2.1
timeFrame: Baseline, week 15
measure: Number of Treatment Related Adverse Events
timeFrame: End of study (15 weeks)
measure: Number of Participants With Undetectable Levels of Estradiol
timeFrame: Baseline and week 15
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Norah L Henry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02539199: Vaginally Administered Versus Per Oral Misoprostol in Induction of Labour
Official title: Vaginally Administered Versus Per Oral Misoprostol in Induction of Labour: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Labour Induction
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: Oulu University Hospital
First posted: 2015-09-02
Enrollment: 270
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effectiveness and safety of vaginally administered misoprostol (Misodel) versus per orally administered misoprostol (Cytotec) in induction of labour in nulliparous women.


Eligibility criteria: Inclusion Criteria:

* Nulliparous
* Singleton at term pregnancy (\>36+6 weeks)
* Unfavourable cervix (Bishop score \< 6)
* Fetal cephalic position

Exclusion Criteria:

* Pre-term pregnancy (\<37 weeks)
* Multiple pregnancy
* Rupture of membranes
* Other than fetal cephalic position
* Intra-uterine growth retardation
* Severe pre-eclampsia
* Severe hypertension
* Previous cesarean section

Primary outcomes:
measure: Cesarean section rate
timeFrame: at time of child birth
Secondary outcomes:
measure: The time from beginning of induction to child birth
timeFrame: up to child birth
measure: Neonatal Apgar score
timeFrame: 1, 5, 10 minutes after child birth
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Kati Tihtonen, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02784899: Effect of Iloprost on Pulmonary Oxygenation in Patients With Low Diffusing Capacity During One-lung Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-05-27
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One lung ventilation (OLV) is essential during thoracic surgery. During OLV, intrapulmonary shunt can be increased resulting hypoxemia. Although OLV technique had been advanced so far, hypoxemia during OLV reaches about 10% in spite of inspired oxygen fraction 100%. Iloprost is a prostaglandin analogue used for pulmonary hypertension, which can decrease pulmonary artery resistance by selectively dilating pulmonary artery. In this prospective, randomized, double blind study, investigators are planning to investigate the effects of iloprost on respiratory physiology (intrapulmonary shunt, deadspace, oxygenation, etc).


Eligibility criteria: Inclusion Criteria:

* scheduled for Video-assisted thoracoscopic surgery (VATS) lobectomy
* 40 \< age \< 80
* American Society of Anaesthesiologists (ASA) physical status classification I\~III
* diffusing capacity (DLCO) \<75% at pre op. pulmonary function test

Exclusion Criteria:

* American Society of Anaesthesiologists (ASA) physical status classification IV
* New York Heart Association (NYHA) class III\~IV
* Severe obstructive lung disease and/or restrictive lung disease patients
* patients with end-organ diseases (i.e. heart failure, respiratory failure, hepatic failure, renal failure)
* arrhythmia
* pregnant women
* disease that can influence the DLCO result (anemia, pulmonary vascular disease)

Primary outcomes:
measure: PaO2(partial pressure of arterial oxygen) ratio
timeFrame: 40 minutes after iloprost inhalation
measure: incidence of intrapulmonary shunt
timeFrame: 40 minutes after iloprost inhalation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT03501199: Comparison of Different Materials Contribution to Implants Stability
Official title: Comparison of Different Materials Contribution to Immediate Implants Stability With Resonance Frequency Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant Failure Nos
Keywords: immediate implant placement
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will use two types of material(PRF-Xenograft) in the buccal gap after immediate dental implant placement. The study design has three groups PRF, graft, and control group. The patients will randomly be assigned to groups by envelop method. The resonance frequency analysis device(Osstell) will be used to measure primary and secondary stabilization. Then the investigators will evaluate each materials' contribution to stability.

Pre-op and 9th month Post-op CBCTs will evaluate about bone loss in mesial-distal and horizontal dimensions.


Eligibility criteria: Inclusion Criteria:

* medically healthy,
* only one maxillary aesthetic region(incisors or premolars) tooth which has two adjacent teeth is indicated for extraction.
* intact buccal socket walls
* the gap between buccal socket wall to implant sholder at least 2 mm.

Exclusion Criteria:

* relevant tooth has more than one root,
* smoking,
* alcohol abuse,
* pregnancy,
* immune-suppressive patients,
* any systemic disease.

Primary outcomes:
measure: Primer Stabilization-Resonance Frequency Analysis
timeFrame: at 0 day
Secondary outcomes:
measure: Seconder Stabilization-Resonance Frequency Analysis
timeFrame: 120th day
measure: Mesial-Distal and Horizontal Bone Loss
timeFrame: 9th month
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University, Faculty of dentistry
Study officials:
affiliation: Consultant
name: Alparslan Esen
role: STUDY_CHAIR
affiliation: Care Provider
name: Gökhan Gürses
role: STUDY_DIRECTOR
References:
Clinical trial NCT05088499: The Role of Genetic Factors in the Development of Epilepsy in the Kazakh Population
Official title: Preventive and Personalized Medicine (2021-2023)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: GWAS
Lead sponsor: Asfendiyarov Kazakh National Medical University
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 600
Sex: ALL
Minimum age (years): 0
Maximum age (years): 5
Standard ages: CHILD
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children of Kazakh ethnic group

Brief summary: This is a GWAS study that aims to identify possible candidate genes associate to epilepsy by exploring single nucleotide polymorphism (SNP) in a group of epilepsy, in the Kazakh population. The investigators hypothesize that the careful phenotyping of the subject sand matching with increase the power to find SNP significantly associate with epilepsy

Detailed description: A genome-wide association study (GWAS) is an approach used in genetics research to associate specific genetic variations with particular diseases. The method involves scanning the genomes from many different people and looking for genetic markers that can be used to predict the presence of a disease. Once such genetic markers are identified, they can be used to understand how genes contribute to the disease and develop better prevention and treatment strategies

Eligibility criteria: Inclusion Criteria:

* Children with seizures, confirmed by EEG and no morphological damage to the brain, confirmed by MRI of the brain;
* The age of the patients is from 0 to 5 years;
* Persons of Kazakh nationality, whose paternal and maternal grandparents are Kazakhs;
* Children are parents or legal guardians who have given written informed consent.

Exclusion Criteria:

* Children over 5 years old;
* Children whose parents, according to the researcher, are mentally or legally incapacitated, which prevents obtaining informed consent;
* Children with seizures with brain damage that cause epilepsy;
* Children of a non-Kazakh ethnic group.

Primary outcomes:
measure: number of SNPs associated with epilepsy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Altynshash Jaxybayeva
Study officials:
affiliation: Astana Medical University, Nur-Sultan, Kazakhstan
name: Altynshash Jaxybayeva
role: STUDY_DIRECTOR
References:
Clinical trial NCT01687699: Effects of Spironolactone on Cardio- and Cerebrovascular Morbidity and Mortality in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: End-stage Renal Failure
Keywords: cardiovascular event
hemodialysis
spironolactone
Lead sponsor: Dialysis Outcomes Heart Failure Aldactone Study Group
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 157
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Aldosterone receptor blockers reduce cardiac-related morbidity and mortality. Recently, we demonstrated that long-term low-dose spironolactone is clinically safe in many hemodialysis (HD) patients. In the present study, we assess whether low-dose spironolactone treatment reduces the high incidence of cardio- and cerebrovascular (CCV) morbidity and mortality in HD patients. The investigators' hypothesis is that aldosterone receptor blockade by spironolactone reduces the risk of both CCV morbidity and death among HD patients.


Eligibility criteria: Inclusion Criteria:

* Hemodialysis patients undergoing 4-hour-long HD thrice a week for at least 2 years
* With an average serum potassium level (immediately before dialysis on the first day of the week) of \<6.5 mEq/l over the previous 2 months
* With a 24-hour urine output of \<500 ml

Exclusion Criteria:

* A history of noncompliance
* Unstable vascular access
* Hypotension
* Hepatic failure
* Active cancer
* Any life-threatening disease other than ESRD

Primary outcomes:
measure: cardio- and cerebrovascular events
Secondary outcomes:
measure: death from all causes
Other outcomes:
Locations:
city: Shizuoka
country: Japan
facility: Shibukawa Clinic
Study officials:
References:
citation: Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.
citation: Matsumoto Y, Mori Y, Kageyama S, Arihara K, Sugiyama T, Ohmura H, Yakushigawa T, Sugiyama H, Shimada Y, Nojima Y, Shio N. Spironolactone reduces cardiovascular and cerebrovascular morbidity and mortality in hemodialysis patients. J Am Coll Cardiol. 2014 Feb 18;63(6):528-36. doi: 10.1016/j.jacc.2013.09.056. Epub 2013 Oct 30.
Clinical trial NCT03047499: Evaluation of the Effect of Botulinum Toxin Type-A Injection Prior to Surgical Correction of Complete Unilateral Cleft Lip Repair by Modified Millard Cheiloplasty
Official title: Evaluation of the Effect of Botulinum Toxin Type-A Injection Prior to Surgical Correction of Complete Unilateral Cleftlip Repair by Modified Millard Cheiloplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esthetic Outcome of Injection of Botulinum Toxin Type-A in Cleft Lip Repair
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 2
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children up to 6 months

Brief summary: Evaluation of the effect of botulinum toxin type-A injection prior to surgical correction of complete unilateral cleftlip repair by modified millard cheiloplasty


Eligibility criteria: Inclusion Criteria:

* Primary cleft lip

Exclusion Criteria:

* Cleft palate

Primary outcomes:
measure: Scar Length
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT01223599: Rhomboid Flap Versus Primary Closure After Excision of Sacrococcygeal Pilonidal Sinus. (A Prospective Randomized Study)
Official title: Rhomboid Flap Versus Primary Closure
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Evaluate and Compare Between Excision and Primary Closure Procedure and Rhomboid Flap Technique for the Treatment of Pilonidal Sinus
Duration of Operation,
Keywords: pilonidal disease
natal cleft
limberg flap
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2010-10-19
Enrollment: 140
Sex: ALL
Minimum age (years): 15
Maximum age (years): 43
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: both sex different age april 2008-march 2010

Brief summary: To evaluate and compare between excision with primary closure of wound and excision with Rhomboid flap reconstruction in the treatment of pilonidal sinus as regard duration of operation, healing time, hospital stay, complications and recurrence rate.


Eligibility criteria: Inclusion Criteria:

* chronic pilonidal sinus

Exclusion Criteria:

* pilonidal abcess

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05262699: Crossmodal Learning in Therapeutic Processes (Task 2-1)
Official title: SFB TRR 169/A3 (2.FP) Crossmodal Learning in Health and Neurological Disease: Neurocomputational Representation and Therapeutic Application (Task 2-1)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Stroke
Keywords: Vibro-tactile stimulation
Neurorehabilitation
Stroke
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: German Research Foundation
name: National Natural Science Foundation of China
First posted: 2022-03-02
Enrollment: 44
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: Interventional study of the effects of vibro-tactile feedback on behavioral deficits and learning during motor training in patients with stroke.


Eligibility criteria: Inclusion Criteria:

* Ischemic stroke according to ICD 10 I61-I69
* Deficit still existing (Rankin score of at least 1 at inclusion)
* Age \>= 18, \<=80
* Existing declaration of consent

Exclusion Criteria:

* Pregnancy
* Lacking capacity for consent

Primary outcomes:
measure: Change from baseline in Action Research Arm Test (ARAT)
timeFrame: One day before (baseline) and one day after seven days of motor training
measure: Change from baseline in Nine-hole peg Test (NHPT)
timeFrame: One day before (baseline) and one day after seven days of motor training
Secondary outcomes:
measure: Change from baseline in Fugl-Meyer Assessment for upper extremity (FMA-UE)
timeFrame: One day before (baseline) and one day after seven days of motor training
measure: Change from baseline in Stroke Impact Scale (SIS)
timeFrame: One day before (baseline) and one day after seven days of motor training
measure: Change from baseline in National Institutes of Health Stroke Scale (NIHSS)
timeFrame: One day before (baseline) and one day after seven days of motor training
measure: Change from baseline in Modified Rankin Scale (mRS)
timeFrame: One day before (baseline) and one day after seven days of motor training
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf, Neurologie
Study officials:
References:
Clinical trial NCT05023499: Perioperative Glutamine Supplementation and Cachexia
Official title: Perioperative Glutamine Supplementation Restores Atrophy of Psoas Muscle in Gastric Adenocarcinoma Patients Undergoing Gastrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glutamine; Metabolic Disorder
Cachexia
Keywords: Gastric cancer
cachexia
psoas muscle
glutamine
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 550
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 550 gastric adenocarcinoma (GA) patients undergoing gastrectomy were enrolled for the study. Computed tomography was used to assess the short axis of the psoas muscle, and the change was calculated between preoperative day and three months after gastrectomy.

Brief summary: Background Sarcopenia is characterized by the degenerative loss of skeletal muscle and is associated with increased adverse surgical outcomes. Glutamine is considered as an immune-modulating formula, which may stimulate protein synthesis in the skeletal muscle but also inhibited protein-degradation. In this study, the investigators calculate the area and volume psoas major muscle (PMMA; PMMV) of the third lumbar vertebral body as the reference of skeletal muscle. The aim of this study is to investigate whether perioperative glutamine supplementation restores atrophy of psoas muscle.

Detailed description: A total of 550 gastric adenocarcinoma (GA) patients undergoing gastrectomy were enrolled for the study. Computed tomography was used to assess the short axis of the psoas muscle, and the change was calculated between preoperative day and three months after gastrectomy. Perioperative glutamine supplementation (PGS) was defined as the subjects with five-day parenteral plus one-month oral use. A linear regression model was performed to predict this association by adjusting clinic-demographics and nutritional calories.

Eligibility criteria: Inclusion Criteria:

* gastric cancer patients undergoing gastrectomy

Exclusion Criteria:

* hepatic or renal failures

Primary outcomes:
measure: area psoas major muscle (PMMA; cm2)
timeFrame: 3 month after surgery
measure: volume of psoas major muscle (PMMV; cm3)
timeFrame: 3 month after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: