louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05425849: Pain Due to Peripheral Intravenous Catheter Insertion
Official title: The Effect of Rose Oil Aromatherapy and Hand-Holding on Pain Due to Peripheral Intravenous Catheter Insertion: A Mixed Method Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to evaluate the effectiveness of rose oil aromatherapy and hand-holding in reducing pain associated with peripheral intravenous catheters (PIVCs) insertion.

Study Hypothesis:

H0-1. The application of rose oil aromatherapy during the PIVC insertion procedure does not reduce the pain associated with the procedure.

H0-2. During the PIVC insertion procedure, the patient's family holding the patient's hand does not reduce the pain associated with the procedure.


Eligibility criteria: Inclusion Criteria:

* patients voluntarily accepted to participate in the study,
* aged between 18-65,
* Turkish literate,
* PIVC placement planned,
* no hematoma, ecchymosis, scar and sensory change in the antecubital region,
* suitable for PIVC insertion with a 20 gauge (pink) catheter in the antecubital region,
* who did not take analgesic drugs for 24 hours and were accompanied by a member of the patient's family (spouse or child).
* patients with an Enhanced Adult DIVA (EA-DIVA) score below 8 for PIVC placement in a single intervention,
* the STAI score below 40

Exclusion Criteria:

* sensitive to smell and had problems in smelling,
* patients with epilepsy, asthma diagnosis,
* patients with a history of allergy

Primary outcomes:
measure: Pain Score
timeFrame: 1 minute-10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Tulay Basak
Study officials:
References:
Clinical trial NCT00452049: The Effect of Parathyroidectomy on Renal Function, Endothelial Function, and Blood Pressure
Official title: Observational Study to Evaluate the Effect of Parathyroidectomy on Renal Function, Endothelial Function and Blood Pressure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperparathyroidism
Hypertension
Keywords: parathyroidectomy
arterial stiffness
renal function
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2007-03-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Renal transplant recipients

Brief summary: Secondary hyperparathyroidism (HPT) is a known complication of chronic renal failure. Elevated concentrations of parathyroid hormone (PTH) play a role not only in the pathogenesis of renal bone disease, but also in the development of cardiovascular risk factors such as disturbed lipid metabolism, glucose intolerance, and hypertension. HPT is also known to play an important role in the development of structural abnormalities of both large arteries and the heart (left ventricular hypertrophy, interstitial fibrosis). In the last couple of years there has been increasing evidence from animal studies that the endothelium is a target organ of PTH.

Hypothesis: PTH has clinically relevant effects on renal hemodynamics, renal function and endothelial function.

Aims:

1. To evaluate the effect of parathyroidectomy (PTX) on renal hemodynamics in stable renal transplant recipients
2. To evaluate the effect of PTX on endothelial function in stable renal transplant recipients/chronic kidney disease (CKD) stage 5 patients
3. To evaluate the effect of PTX on blood pressure in stable renal transplant recipients/CKD stage 5 patients


Eligibility criteria: Inclusion Criteria:

1. Stable renal transplant recipients/CKD stage 5D patients.
2. Age between 18 years and 85 years.
3. Signed informed consent.
4. PTX scheduled because of severe hyperparathyroidism (day 0)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hopsital Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Pieter Evenepoel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Evenepoel P, Claes K, Viaene L, Bammens B, Meijers B, Naesens M, Sprangers B, Kuypers D. Decreased Circulating Sclerostin Levels in Renal Transplant Recipients With Persistent Hyperparathyroidism. Transplantation. 2016 Oct;100(10):2188-93. doi: 10.1097/TP.0000000000001311.
Clinical trial NCT03577249: Biological Effects of Citrate-buffered Solutions on Dialysis Efficiency and Systemic Inflammation
Official title: Biological Effects of Citrate-buffered Solutions on Dialysis Efficiency and Systemic Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Renal Insufficiency, Chronic
Inflammation
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Intervention model description: 45 patients with end stage renal disease will be treated with dialysis solution A (standard of care: acetate-buffered) for 3 months then with solution B (acetate-free, citrate buffered, otherwise identical to solution A) for 3 months and then with solution A for the final 3 months
Primary purpose: TREATMENT

Brief summary: In this study 45 patients undergoing weekly dialysis for chronic end stage renal disease will be enrolled. The patients will be treated with a standard dialysis solution, containing acetate buffer, for 3 months; subsequently the acetate will be substituted with citrate anion for the 3 following months and then, the last 3 months, the standard acetate-solution will be restarted. The aim of the study is to assess if acetate-to-citrate switch in the dialysis solution influences dialysis efficiency and patient inflammatory state.


Eligibility criteria: Inclusion Criteria:

* age \>18 years
* creatinine clearance \<5ml/min
* treatment with bicarbonate HD (BIC-HD) or on-line hemodiafiltration (OL-HDF) 3 times per week for at least 6 months prior to study start
* treated at Dialysis unit of: Città della Salute e della Scienza University Hospital, Torino, Italy

Exclusion Criteria:

* known neoplastic disease
* active chronic inflammatory disease
* active acute inflammatory disease

Primary outcomes:
measure: Change in serum CRP (C-reactive protein)
timeFrame: Months 4th to 6th
Secondary outcomes:
measure: Change in dialysis efficiency
timeFrame: Every 3 months (month 0, 6, 3 and completion - 9)
measure: Change in serum CRP (C-reactive protein)
timeFrame: Every 3 months (month 0, 6, 3 and completion - 9)
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Città della Salute e Della Scienza di Torino - Presidi CTO e Molinette
state: To
Study officials:
References:
Clinical trial NCT04372849: Effects of Age and Obesity on Brain Insulin Sensitivity
Official title: Insulinsensitivität Des Menschlichen Zentralnervensystems Mit Fortschreitendem Alter: Kernspintomographische Untersuchung Mit Intranasaler Gabe Von Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Obesity
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Obesity and especially type 2 diabetes (T2D) increases the risk of neurocognitive dysfunctions including adverse effects on brain structure and function. Recent evidence from clinical studies have shown that T2D almost doubles the risk for dementia. As the population gets older, age-related chronic diseases, as T2D, become more prevalent. Scientific evidence is emerging that there are several links between metabolic and neurocognitive functions. Impaired insulin action (i.e. insulin resistance), the main hallmark of T2D, has been suggested as a likely shared common pathophysiological mechanism. However, the neural processes that determine how insulin resistance is are connected to the onset and progression of T2D and dementia remain unclear. In this context, the overall aim is to study brain insulin resistance to disentangle age-related and obesity related brain insulin resistance in healthy normal and overweight/obese persons at the age of 20 to 70 years . To this end, the investigators will assess brain insulin action using intranasal insulin/placebo during functional Magnetic Resonance Imaging (fMRI). Additionally, structural changes and cognitive processes will be assessed as secondary variables.


Eligibility criteria: Inclusion Criteria:

* Body-Mass Index (BMI) between 19-35 kg/m2
* HbA1c ≤6.0%
* normal glucose tolerance during 75g oral glucose tolerance test (OGTT)

Exclusion Criteria:

* Not removable metal parts in or on the body
* manifest cardiovascular disease
* claustrophobia
* recent surgery (less than 3 months)
* Simultaneous participation in other studies
* Acute disease or infection within the last 4 weeks
* neurological and psychiatric disorders
* treatment with centrally acting drugs
* hemoglobin Hb \<13g / dl
* Hypersensitivity to any of the substances used

Primary outcomes:
measure: Brain insulin sensitivity in different age,weight and sex groups
timeFrame: 30 minutes after administration of nasal insulin
Secondary outcomes:
measure: Whole-body insulin sensitivity
timeFrame: 2 hours
measure: Correlation with autonomous nervous system activity
timeFrame: 10 - 150 minutes post nasal spray
measure: Correlation with cognitive function
timeFrame: 1 hours
measure: Response to food cues
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University of Tuebingen, Department of Internal Medicine IV
Study officials:
References:
Clinical trial NCT02977949: The Effects of Seasonal Changes in Osteoporosis Treatment
Official title: The Effects of Seasonal Changes in Osteoporosis Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Selective Estrogen Receptor Modulator (SERM)
Keywords: SERM
Season
Variation
Vitamin D
Lead sponsor: Tomidahama Hospital
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 200
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Osteoporosis patients using raloxifene more for two years.

Brief summary: There are few reports concerning to the seasonal variation of osteoporosis treatment. In this study, we plan to compare clinical efficacy and safety by seasons.

Detailed description: Vitamin D insufficiency is common in many countries. Vitamin D insufficiency is associated with osteoporosis and the responses to osteoporosis treatment. 25-hydroxyvitamin D (25OHD) is considered to be the best estimate of body stores of vitamin D and the seasonal variation of 25OHD is well known. But there are few reports concerning to the seasonal variation of osteoporosis treatment. In this study, we plan to compare clinical efficacy and safety by seasons in patients treated by raloxifene.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women

Exclusion Criteria:

* Patients who could not use SERM

Primary outcomes:
measure: Effects of raloxifene on bone mineral density in postmenopausal osteoporosis.
timeFrame: Up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Yokkaichi
country: Japan
facility: Tomidahama Hospital
state: Mie
Study officials:
affiliation: Tomidahama Hospital
name: Rui Niimi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02628249: Rate-limiting Amino Acids in Endurance-trained Athlete
Official title: Application of Indicator Amino Acid Oxidation Method to Investigate the Rate-limiting Amino Acids in Endurance Trained Athlete
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Increased Metabolic Requirement
Healthy
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Protein requirements in individuals who participate in endurance-based exercise training have been suggested to be greater than the current recommended dietary allowance (RDA).

The biological value of protein depends on the amino acid composition. As liebig's law of the minimum, the protein synthesis is limited due to the lack of single rate limiting amino acid. In this case, the first rate limiting amino acid determines protein intakes to maximize the protein synthesis. Adding a small amount of rate-limiting amino acid to the diet improves the biological value of its protein diet.

The indicator amino acid oxidation (IAAO) method has clarified the individual amino acid requirement in children, normal healthy adult and clinical populations. however, the IAAO method has never been utilized for determining the first rate limiting amino acid.

Therefore, the purpose of this study is to address of IAAO method to be applied for determining the rate-limiting amino acid in endurance athlete.


Eligibility criteria: Gender: Male

Age limit: Minimum age 18 years - Maximum age 35 years

Accepts Healthy Volunteers : yes

Inclusion Criteria:

* Endurance-trained participants who regularly more than 40 km/week
* Ability to perform the exercise stimulus (20 km run) on metabolic trial.

Exclusion Criteria:

* Inability to meet health and physical activity guidelines according to the physical activity readiness questionnaire (PAR-Q+)
* Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption)
* Regular tobacco use
* Illicit drug use

Primary outcomes:
measure: 13CO2 (carbon dioxide) excretion rate (μmol/kg/h)
timeFrame: At 8 hours after the end of exercise
Secondary outcomes:
measure: [13C]phenylalanine oxidation rate (μmol/kg/h)
timeFrame: at 8 hours after the end of exercise
Other outcomes:
Locations:
Study officials:
References:
citation: Kato H, Suzuki K, Bannai M, Moore DR. Branched-Chain Amino Acids Are the Primary Limiting Amino Acids in the Diets of Endurance-Trained Men after a Bout of Prolonged Exercise. J Nutr. 2018 Jun 1;148(6):925-931. doi: 10.1093/jn/nxy048.
Clinical trial NCT06387849: Aromatherapy Effect on Pain and Anxiety After C-section
Official title: Effect of Aromatherapy Using Lavender Essential Oil on Pain and Anxiety After C-section: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Pain
Post-operative Anxiety
Keywords: Cesarean
Pain
Anxiety
Aromatherapy
Lavender
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective randomized triple blinded study conducted in the obstetrics gynecology department of Ben Arous hospital over a period of four months and 10 days between April 2023 and August 2023.

The aim of this study was to evaluate the effectiveness of lavender aromatherapy on postoperative pain and anxiety after cesarean section under spinal anesthesia in Tunisian women.


Eligibility criteria: Inclusion Criteria:

* All women who gave birth by cesarean section under spinal anesthesia in the obstetrics and gynecology department at the Ben Arous regional hospital who met the following criteria were included in this study:

  * Age between 18 and 45 years old
  * Term of pregnancy at the time of delivery ≥ 37 weeks of Gestation.
  * A minimum level of primary education as a prerequisite to answer the questions (in particular the STAI items).
  * Classified ASA 1 or 2 of the American Society of Anesthesiology (ASA) classification.
  * Having no history of cancer or chronic pain.
  * Free from any psychiatric pathology.
  * And having not presented any intra- or post-operative complications.

Exclusion Criteria:

The investigators excluded patients in our study:

* Having given birth to a stillborn or a suffering newborn requiring transfer to neonatal intensive care.
* Having received painkillers in the post-operative period.
* Having olfactory disorders.
* Having a substance abuse problem.
* Having a known allergy to lavender or other aromatic plants.
* who did not agree to participate in the study or who did not continue all stages of the trial.

Primary outcomes:
measure: Post-operative pain level
timeFrame: two to twelve hours after surgery
measure: Post-operative anxiety level
timeFrame: two to twelve hours after surgery
Secondary outcomes:
measure: Heart Rate (HR)
timeFrame: two to twelve hours after surgery
measure: Systolic Blood Pressure (SBP)
timeFrame: two to twelve hours after surgery
measure: Diastolic Blood Pressure (DBP)
timeFrame: two to twelve hours after surgery
measure: Respiratory Rate (RR)
timeFrame: two to twelve hours after surgery
measure: Pulsatile Oxygen Saturation
timeFrame: two to twelve hours after surgery
Other outcomes:
Locations:
city: Ben Arous
country: Tunisia
facility: Ben Arous Regional Hospital
Study officials:
affiliation: University of Tunis el Manar, Faculty of medicine
name: Hajer Bettaieb, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04426149: Clinical Effects of Oral Trehalose In Patients With Spinocerebellar Ataxia 3
Official title: Clinical Effects of Oral Trehalose In Patients With Spinocerebellar Ataxia 3: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinocerebellar Ataxia 3
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There are no clinically established treatments which have been proven to delay the disease progression in spinocerebellar ataxia (SCA) 3. Most available treatments are only for symptom alleviation, and thus the majority of patients will eventually progress to needing and wheel chair and eventually bedridden.

As trehalose appear to be potentially promising treatment in SCA, the investigators aim to conduct this study using oral trehalose in our genetically confirmed SCA 3 patients.

Detailed description: This prospective single arm interventional study involved 13 genetically confirmed spinocerebellar ataxia (SCA) 3 patients with no concomitant diabetes, over 6 months. Following baseline assessment, patients were instructed to ingest 100g of oral trehalose diluted in 500ml of water or other beverages daily. Assessments were performed at baseline, 2, 4 and 6 months using ataxia rating scales (SARA, SCAFI and INAS) and EQ-5D-3L scale for quality of life assessment.

Eligibility criteria: Inclusion Criteria:

1. DNA diagnosis of SCA 3 in the study subject of his/ her affected family member(s)
2. Consent to participate in the study
3. The age of 18 years and older

Exclusion Criteria:

1. Unconfirmed SCA 3
2. Concomitant disorder(s) that affect SARA and other ataxia measures used in this study
3. Diabetes
4. Malabsorption of trehalose underlies intolerance to mushrooms, since the lack of absorption results in diarrhoea and intestinal distress.
5. Less than 18 years old

Primary outcomes:
measure: scale of rating of ataxia (SARA) score months,
timeFrame: 2 monthly intervals for 6 months
measure: SCA Functional Index Scores
timeFrame: 2 monthly intervals for 6 months
measure: EQ5D3L - quality of life scores
timeFrame: 2 monthly intervals for 6 months
Secondary outcomes:
measure: Side effects Profile
timeFrame: 2 monthly intervals for 6 months
measure: Blood investigation
timeFrame: At baseline and at 6 months
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Pusat Perubatan Universiti Kebangsaan Malaysia
Study officials:
affiliation: norlinah@ppukm.ukm.edu.my
name: NORLINAH MOHAMED IBRAHIM, MBBCH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06290349: Efficacy and Safety of DA5221-T When Added to Ongoing DA5221-B1 and DA5221-B2 Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA5221-T When Added to Ongoing DA5221-B1 and DA5221-B2 Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-04
Enrollment: 162
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy and safety of adding the SGLT-2 inhibitor DA5221-T to the combination therapy of DA5221-B1 and the DPP-4 inhibitor DA5221-B2 in patients with type 2 diabetes who have inadequate blood glucose control. The study focuses on assessing the effectiveness and safety of the triple combination therapy.


Eligibility criteria: Inclusion Criteria:

1. Patients with type II diabetes mellitus aged 19 years or older
2. Patients who had taken DA5221-B1 and DA5221-B2(or another DPP-4 inhibitor is allowed) combination therapy at the same dose for at least 8 weeks prior to the screening visit
3. Patients with fasting plasma glucose≤270mg/dL at the screening visit
4. Patients with 18.5kg/m\^2≤BMI≤40kg/m\^2 at the screening visit
5. Patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study

Exclusion Criteria:

1. Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis
2. Patients with a medical history of New York Heart Association(NYHA) class III\~IV heart failure or with congestive heart failure, acute and unstable heart failure
3. Patients with severe infectious disease or severe traumatic systemic disorders
4. Patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
5. Patients with galactose intolerance, lapp lactase deficiency, glucosegalactose malabsorption

Primary outcomes:
measure: Change from the baseline in HbA1c (%) after 24 weeks
timeFrame: Baseline, 24 weeks
Secondary outcomes:
measure: Change from the baseline in fasting plasma glucose(mg/dL) after 24 weeks
timeFrame: Baseline, 24 weeks
measure: Change from the baseline in HbA1c response rate(<7.0%, <6.5%) after 24 weeks
timeFrame: Baseline, 24 weeks
measure: Change from the baseline in weight after 24 weeks
timeFrame: Baseline, 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University college of Medicine
Study officials:
References: