louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03361566: Short-term Regulation of Energy and Macronutrient Balance: Impact of Energy Flux
Official title: Einfluss Des Energy Flux Auf Die Kurzfristige Regulation Der Energie- Und Makronährstoffbilanz
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: physical activity
energy balance
caloric restriction
overfeeding
appetite regulation
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Aim of the study is to investigate the impact of energy flux (achieved by changes in physical activity) under the conditions of energy balance, caloric restriction and overfeeding in healthy subjects.

Detailed description: A low energy flux is achieved by low energy expenditure, equivalent to low physical activity and with a corresponding low energy intake. A high energy flux is achieved by high energy expenditure, equivalent to high physical activity and with a corresponding high energy intake, respectively.

The protocol of this randomized, intra-individual nutrition intervention includes 12 one-day interventions with 3 different levels of energy flux and 4 different diet conditions.

Eligibility criteria: Inclusion Criteria:

* 20-40 years of age
* healthy
* BMI between 18.5 and 31 kg/m2

Exclusion Criteria:

* smoking
* food allergies
* alternative nutrition habits like vegetarian / vegan
* chronic diseases
* regular medication intake
* claustrophobia
* weight loss \> 5 kg in the last 3 years

Primary outcomes:
measure: energy balance
timeFrame: 24 hours
Secondary outcomes:
measure: ghrelin levels
timeFrame: every 2 hours during the day over 14 hours
measure: arterial stiffness
timeFrame: 15 hours
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Institute of Nutritional Medicine, University of Hohenheim
Study officials:
affiliation: University of Hohenheim, Stuttgart, Germany
name: Anja Bosy-Westphal, Prof PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hagele FA, Busing F, Nas A, Hasler M, Muller MJ, Blundell JE, Bosy-Westphal A. Appetite Control Is Improved by Acute Increases in Energy Turnover at Different Levels of Energy Balance. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4481-4491. doi: 10.1210/jc.2019-01164.
Clinical trial NCT03724266: Effect of Using Nanochitosan Versus Calcium Hydroxide as Disinfectant on Pain and Apical Bone Healing
Official title: Effect of Using Nanochitosan Versus Calcium Hydroxide as Intracanal Medications on the Postoperative Pain and Apical Bone Healing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Healing
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: postoperative pain after intervention
Primary purpose: TREATMENT

Brief summary: Effect of Using Nanochitosan versus Calcium Hydroxide as Intracanal Medications on the Postoperative Pain and Apical Bone Healing

Detailed description: PICO approach P (population): maxillary anterior teeth having necrotic pulp with symptomatic apical periodontitis with evidence of apical radiolucency (minimum size 2 mm x 2 mm).

I (intervention):0.2% nanochitosan as intracanal medication. C (control): calcium hydroxide paste intracanal medication.

O (outcome):

Primary outcome: postoperative pain at time interval 4, 12, 24, 48, 72 hours

Secondary outcome:

1. Postoperative pain, swelling, palpation, percussion and mobility at one week, 3, 6, 12 months
2. Number of analgesic tablets used at 4, 12, 24, 48, 72 hours and one week.
3. healing of apical periodontitis using CBCT at 3, 6, 12 months

Eligibility criteria: Inclusion criteria:

* Patients in good general health.
* Patient's age ranging between 20-40 years with no sex predilection.
* Maxillary anterior teeth with non-vital pulp and symptomatic apical periodontitis.
* Evidence of apical radiolucency (minimum size 2 mm x 2 mm).
* Patients' acceptance to participate in the study.

Exclusion criteria:

* Medically compromised patients with a severe systemic condition.
* Pregnant female patients.
* Patients who had taken any antibiotic or analgesics during the past 24 hours.
* Presence of a swelling because emergency management may include incision and drainage.
* Retreatment cases.
* Generalized periodontitis (calculus, deep pockets).
* Out of normal variations (open apex- severely curved canal- obstructed canal).

Primary outcomes:
measure: change in postoperative pain after intervention of chitosan: NRS
timeFrame: 4,12,24,27 hours
Secondary outcomes:
measure: change in healing of apical periodontitis
timeFrame: 3,6,12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04879966: A Cohort Study Comparing IFX to CS for Moderate to Severe UC
Official title: A Multicenter Prospective Cohort Study Comparing Infliximab to Corticosteroids for Moderate to Severe Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Moderate to Severe Ulcerative Colitis
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults patinets of moderately to severely active ulcerative colitis who will initiate IFX or CS

Brief summary: The first-line treatment strategy of moderate to severe UC was a important question at issue. The biological agents had potentiality to alter the disease course of UC. The AGA clinical guidelines had conditional recommend that IFX and other biological agene migtht be first-line therapy for high-risk UC patints but only had low grade evidence.We launched this multicenter prospective cohort trial to compare the efficacy and safety of infliximab (IFX) and corticosteroids(CS) when they was used as first-line therapy in UC patients.


Eligibility criteria: Inclusion Criteria:

* moderately to severely active ulcerative colitis, defined as a total score of 6 to 12 on the Mayo scale (scores range from 0 to 12, with higher scores indicating more severe disease) and a subscore of at least 2 on the endoscopic component of the Mayo scale (subscores on each of the four components of the Mayo scale range from 0 to 3)
* Patients who had colonic involvement of at least 15 cm
* Patients who had a confirmed diagnosis of ulcerative colitis at least 3 months before screening and confirmed by Pathology

Exclusion Criteria:

* Patients who had previously used any TNF inhibitor
* Patients who were steroid-dependent or steriod-resistant
* Patients who had undergone subtotal colectomy or total colectomy
* Patients who had stoma

Primary outcomes:
measure: clinical remission
timeFrame: week 14
Secondary outcomes:
measure: clinical response in induction phase
timeFrame: week 14
measure: mucosal healing in induction phase
timeFrame: week 14
measure: histological healing in induction phase
timeFrame: week 14
measure: clinical response in maintenance phase
timeFrame: week 52
measure: mucosal healing in maintenance phase
timeFrame: week 52
measure: histological healing in maintenance phase
timeFrame: week 52
measure: quality of life in induction phase
timeFrame: week 14
measure: quality of life in maintenance phase
timeFrame: week 52
measure: adverse events
timeFrame: week 52
Other outcomes:
Locations:
city: Guandong
country: China
facility: The Sixth Affiliated Hospital, Sun Yat-sen University
Study officials:
References:
Clinical trial NCT02949466: Additional Effects of Triamcinolone to Hyaluronic Acid on Knee Osteoarthritis
Official title: Additional Therapeutic Effects of Triamcinolone to Hyaluronic Acid on Knee Osteoarthritis: A Double Blind, Randomized-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Physical Activity
Functional Performance
Keywords: knee osteoarthritis
triamcinolone
therapeutic effects
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2016-10-31
Enrollment: 56
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Using a double-blind, randomized controlled design to investigate the additional therapeutic effects of 3 times of combined triamcinolone and hyaluronic acid injections to 3 times of hyaluronic acid injections to patients with knee osteoarthritis.

Detailed description: A total of 56 patients will be enrolled and randomized into two groups, including 3 times of triamcinolone combined hyaluronic acid injections group and 3 times of hyaluronic acid injections group.

The triamcinolone combined hyaluronic acid injections group will receive 3 times of triamcinolone combined hyaluronic acid injection per week in three weeks; the hyaluronic acid group will receive hyaluronic acid injection in three weeks.

Physical activities and functional performance will be evaluated at before injection, at after one week, one month, three months, and six months of completion of 3 times of injections.

Eligibility criteria: Inclusion Criteria:

* knee osteoarthritis with Kellgren/Lawrence grade II or III

Exclusion Criteria:

* who have neurological deficit, such as stroke who have implant in knee

Primary outcomes:
measure: Functional performance assessed with the Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: changes from baseline to at after one week, one month, three months, and six months of completion of injections
Secondary outcomes:
measure: 10 meter walk test
timeFrame: changes from baseline to at after one week, one month, three months, and six months of completion of injections
measure: Quality of life assessed with the Knee Injury and Osteoarthritis Outcome Score
timeFrame: changes from baseline to at after one week, one month, three months, and six months of completion of injections
measure: 5 times rapid chair rising test
timeFrame: changes from baseline to at after one week, one month, three months, and six months of completion of injections
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Ru-Lan Hsieh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang CP, Lee WC, Hsieh RL. Effects of Repeated Co-Injections of Corticosteroids and Hyaluronic Acid on Knee Osteoarthritis: A Prospective, Double-Blind Randomized Controlled Trial. Am J Med. 2022 May;135(5):641-649. doi: 10.1016/j.amjmed.2021.11.016. Epub 2021 Dec 24.
Clinical trial NCT01853566: Effects of Growth Hormone Administration on Muscle Strength and Body Composition in Men Over 50 Years Old
Official title: Effects of Growth Hormone Administration on Muscle Strength and Body Composition in Men Over 50 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Muscle Strength
Growth Hormone
men
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 13
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The growth hormone (GH) secretion declines gradually with age, with studies demonstrating a progressive reduction of 14% secretion per decade of life beginning in the second decade. Other studies suggest a disruption in GH secretion in elderly people. These findings suggest a possible association between growth hormone deficiency (GHD) and the ageing process.GH replacement is well known to improve body composition, leading to a decrease in total body fat and an increase in lean body mass. However, GH replacement has only shown an effect on muscle strength in GH-deficient adults subjected to long-term GH therapy. Few studies have evaluated the effect of GH replacement on muscle strength in elderly people engaged in a program of exercise training.Our purpose is to evaluate the effect of GH therapy on muscle strength in healthy, non-sedentary men over 50 years old.

Detailed description: At baseline, subjects are submitted to evaluation of GH secretion, testosterone level, body composition, and muscle strength. Absence of GHD and normal testosterone levels were necessary for the inclusion in the study. These parameters will be evaluated after 6 months of GH use x placebo.

Eligibility criteria: Inclusion Criteria:

* Healthy and non-sedentary men aged 50-70 years

Exclusion Criteria:

* pituitary disease, GH use in the last 12 months, severe acute disease, hepatic and/or renal chronic disease, uncontrolled systemic arterial hypertension, diabetes mellitus, psychiatric disorders, history of cancer, non-treated hypogonadism and the presence of any other disease that could interfere with the somatotrophic axis.

Primary outcomes:
measure: Muscle strength after GH replacement
timeFrame: after 6 months of GH replacement
Secondary outcomes:
measure: body composition after growth hormone replacement
timeFrame: after 6 months of growth hormone
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Clementino Fraga Filho - UFRJ
Study officials:
affiliation: Hospital Universitário Clementino Fraga Filho - UFRJ
name: Ana Beatriz tavares
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tavares AB, Micmacher E, Biesek S, Assumpcao R, Redorat R, Veloso U, Vaisman M, Farinatti PT, Conceicao F. Effects of Growth Hormone Administration on Muscle Strength in Men over 50 Years Old. Int J Endocrinol. 2013;2013:942030. doi: 10.1155/2013/942030. Epub 2013 Dec 8.
Clinical trial NCT05033366: Relationship Between Fertility Hormone Patterns and Pregnancy Rates.
Official title: Relationship Between Fertility Hormone Patterns and Pregnancy Rates.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pregnancy Related
Hormone Deficiency
Lead sponsor: MFB Fertility
Sponsor class: INDUSTRY
First posted: 2021-09-02
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females age 18 - no limit who are using, or have used, the Proov hormone test strips and the Proov app for at least one full cycle.

Brief summary: The purpose of this study is to determine if certain patterns of hormone levels during the menstrual cycle are correlated with different pregnancy outcomes.

Detailed description: Proov tests are fertility tracking tests. They are used for monitoring ovulation at home, and are able to measure one or more hormones. These hormones can predict and confirm ovulation. Tracking these hormones can help a woman understand if she is ovulating, and can help to identify problems that could be preventing pregnancy.

After giving permission to access your testing history collected in the Proov app from March 2020 to April 2022, you will complete an online survey about your fertility test results and pregnancy status. You will also be asked information regarding your age, race, smoking status, and BMI. Your test results logged in the Proov app will be shared automatically. You will need 10-20 minutes to fill out the fertility survey.

Eligibility criteria: Inclusion Criteria:

1. Female
2. Age 18 - no limit
3. Have completed one full cycle using the Proov app

Exclusion Criteria:

1. Male
2. Have not completed one full cycle using the Proov app

Primary outcomes:
measure: self reported pregnancy
timeFrame: Two menstrual cycle, up to 45 days each
Secondary outcomes:
measure: self reported first trimester pregnancy loss
timeFrame: Three months
Other outcomes:
Locations:
city: Boulder
country: United States
facility: MFB Fertility
state: Colorado
Study officials:
affiliation: MFB Fertility
name: Amy Beckely, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05002166: Clinical Characteristics and Risk Factors of Children Suffering From Inflammatory Bowel Diseases At Assiut University Children Hospital
Official title: Clinical Characteristics and Risk Factors of Children Suffering From Inflammatory Bowel Diseases At Assiut University Children Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 20
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted with inflammatory bowel disease

Brief summary: Clinical Characteristics and Risk factors of Children Suffering from Inflammatory Bowel Diseases At Assiut University Children Hospital

Detailed description: All patients admitted with inflammatory bowel disease will be subjected to:

1. History: including name, age ,sex ,family history, consanguinity, history of rectal bleeding, mucus or blood in the stool, diarrhea, abdominal pain ,vomiting ,nausea and loss of appetite.
2. Examination: including general examination, chest, cardiac, abdominal and neurological examination
3. Investigation:including labortatory such as fecal calprotectin ,CRP,CBC,ESR. Endoscopic examination of the gastrointestinal tract Histological examination of the biopsies retrieved during gastrointestinal endoscope.

Eligibility criteria: Inclusion Criteria:

- Children aged less than 18 years with a confirmed diagnosis of IBD.

Exclusion Criteria:

* Children with colitis other than IBD or children with systemic diseases affecting GIT.

Primary outcomes:
measure: Clinical characteristics and risk factors for IBD
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Christine zaghloul noos
Study officials:
affiliation: Assiut University
name: Shereen Mansour, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06129266: Oral Care With Breast Milk in Preterm Newborns Fed by Tube
Official title: Oral Care With Breast Milk in Preterm Newborns Fed by Tube:A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastmilk
Oral Care
Keywords: breastmilk
oral care
newborn
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 64
Sex: ALL
Minimum age (years): 28
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It was conducted to evaluate Oral Care with Breast Milk in Preterm Newborns Fed by Tube

Detailed description: Newborns selected according to the randomization group will receive nursing care, including oral care and feeding, from the same person twice a day, at 09:00 in the morning and 15:00 in the afternoon. Breast milk (BM) will be used for oral care. At each treatment, two ml BM should be dropped onto sterile gauze to clean the cheeks, tongue and palate. Process steps; After hand hygiene is achieved, it will be done using disposable gloves.

Eligibility criteria: Inclusion Criteria:

* -Staying in the neonatal intensive care unit
* Being fed by gavage
* Babies with no oral intake (nonperoral-NPO)
* Babies fed with breast milk and/or formula

Exclusion Criteria:

* Babies who are exclusively breastfed
* Cleft palate/lip
* Major congenital anomaly
* Intubated babies

Primary outcomes:
measure: Oral Care with Breast Milk in Tube-Fed Preterm Newborns: Randomized Controlled Study
timeFrame: from the same person twice a day, at 09:00 in the morning and 15:00 in the afternoon.
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University
Study officials:
References:
Clinical trial NCT00348166: Does Undercorrection of Myopia Retard Myopia Progression Among Kindergarten Children?
Official title: Does Undercorrection of Myopia Retard Myopia Progression Among Kindergarten
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Refractive Error - Myopia
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2006-07-04
Enrollment: 180
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: The purpose of this study is to find out if undercorrection of myopia slow down the progression of myopia in kindergarten children.


Eligibility criteria: Inclusion Criteria:

1. Children of chinese descent aged 5 - 6yrs
2. Refractive error of -1.00 to -3.00Ds
3. Less than 1.50 astigmatism in each eye. (No oblique axis)
4. Visual acuity is 6/6 or better in both eyes.
5. No binocular problems, no anisometropia \>1.50D
6. Will be staying in S'pore for at least 2 years.

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Singapore National Eye Centre
name: Quah Boon Long
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02972866: Clinical Study, Non Inferiority Between Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Rhinitis
Official title: Phase III, Multicenter, Randomized, Simple-blinded, Paralel Groups to Evaluate Non Inferiority of Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Persistent Rhinitis Moderate to Severe
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Rhinitis, Allergic, Perennial
Lead sponsor: Eurofarma Laboratorios S.A.
Sponsor class: INDUSTRY
First posted: 2016-11-25
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate non inferiority of Eurofarma budesonide nasal spary x referral Astrazeneca budesonide. Half patients will receive Eurofarma medication and half patients will receive Astrazeneca medication. There is no placebo group.

Detailed description: Budesonide is a medicine already very used and registered about 20 years. Eurofarma has the intention to collect more data about safety and efficacy and present them to local authority.

This study was draw to treat patients with persisntent rhinits moderate to severe in sites localted locally in Brasil.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 12.
2. History of alergic persistent rhinitis moderate to severe at least 2 years.
3. Proved alergic using PRICK or RAST test.
4. Nasal symptoms (NIS) \> 3 and nasal obstruction \>1.
5. Indication of nasal corticorteroids use..
6. Washout of nasal corticorteroids for 14 days.
7. ICF.

Exclusion Criteria:

1. Other types of rhinitis;
2. Asthma non controled
3. Use of oral/injectable corticoids 30 days before screening.
4. patients not eligible to complete diaries.
5. patients with alergy to any substance of medicines.
6. non controlled desease.

Primary outcomes:
measure: Demonstrate non inferiority of Noex comparable with referral product Budecort Aqua in the treatment of rinithis moderate to severe during 4 weeks of treatment.
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Allergisa pesquisa dermato-cosmética ltda
state: São Paulo
Study officials:
affiliation: Allergisa Pesquisa Dermato-Cosmética Ltda
name: Mauro Acir Crippa Junior
role: PRINCIPAL_INVESTIGATOR
References: