louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01523613: High-strength Glass-ionomer Dental Restorations
Official title: Clinical Performance of High-Viscous Glass-Ionomer Restorative Systems In Class II Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: Dental caries
Proximal surfaces
Posterior teeth
Carious lesions
Tooth diseases
Dental restorations
Glass-ionomer
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Mott Children's Health Center
name: Dentsply International
First posted: 2012-02-01
Enrollment: 93
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to extend our knowledge concerning the clinical performance of two dental filling materials in molars. The study will compare two high-strength glass-ionomer filling materials.

The investigators hypothesize that after two years (1) the clinical performance of both filling materials shows a similar survival rate, (2) the ChemFil Rock fillings show similar or higher incidence of fracture than Fuji IX GP fillings.

Detailed description: In this longitudinal prospective randomized control clinical trial, posterior restorations (Class II) will be placed and evaluated for their clinical performance. The study will compare two restorative systems currently on the market in USA: both high-strength glass-ionomer (GI) restorative materials. The study restorations will be monitored for a period of up to 2 years.

Eligibility criteria: Inclusion Criteria:

* 7-16 year old
* in need of one or two approximal fillings in molars

Exclusion Criteria:

* known allergies to calcium-aluminum-zinc-fluoro-phosphor-silicate glass or any other of glassionomer components

Primary outcomes:
measure: Survival Rate
timeFrame: 2 years
Secondary outcomes:
measure: Caries Incidence Associated With Restoration
timeFrame: 2 years
measure: Restored Tooth Performance
timeFrame: 2 years
Other outcomes:
Locations:
city: Flint
country: United States
facility: Mott Childrens' Health Center
state: Michigan
Study officials:
affiliation: U Michigan
name: Mathilde C Peters, DMD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04325113: Post Tonsillectomy Analgesia Comparison After Surgery Site Spray of Local Anesthesics
Official title: Post Tonsillectomy Analgesia Comparison After Surgery Site Spray of NaCl 0,9%, Xylocaine 2% or Levobupivacaine 0,5%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 44
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Check analgesia after tonsillectomy in adults

Detailed description: We hypothesize that a vaporization of local anesthetics in the tonsil lodge would reduce postoperative pain.

Eligibility criteria: Inclusion Criteria:

* Tonsillectomy

Exclusion Criteria:

* Gastric or duodenal ulcer
* Diabetes
* Kidney failure
* Chronic pain and fibromyalgia

Primary outcomes:
measure: Patient's satisfaction and pain score
timeFrame: until 10 days after the tonsillectomy.
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Javillier
Study officials:
References:
Clinical trial NCT05500313: The Effect of Education and Counseling Based on HypnoBreastfeeding
Official title: The Effect of Education and Counseling Based on HypnoBreastfeeding Philosophy on Breastfeeding Status, Breastfeeding Self-Efficacy and Breastfeeding Motivation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypno-breastfeeding Education
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine the effect of education and counseling based on the hypno-breastfeeding philosophy given in the antenatal period on only breastfeeding status, breastfeeding self-efficacy and breastfeeding motivation.

Detailed description: This is a non-randomized experimental study. Data were collected from 80 women who attended hypno-breastfeeding-based education or standart breastfeeding education from Turkey between September 2021 and February 2022. Participants who met the inclusion criteria were informed about the purpose of the study and hypno-breastfeeding-based education or standart breastfeeding education, informed consent was obtained from those who agreed to participate. Data were collected at the time of consent to the study, pre-education, post-education, 1 week and 8 weeks after birth. Collected by the first author. The CONSORT directive was followed in the planning, implementation and writing of the research.

Eligibility criteria: Inclusion Criteria:

* Must be able to a healthy pregnancy,
* Native language is Turkish,
* Have single fetus
* Must be able to breastfeeding with her baby
* Must be able to join wit education.

Exclusion Criteria:

* Complications,
* Psychological or psychiatric disorder,
* Un-available follow-upps

Primary outcomes:
measure: Level of breastfeeding self-efficacy
timeFrame: Between 28-34 weeks of pregnancy
measure: Level of breastfeeding self-efficacy
timeFrame: Between 30-36 weeks of pregnancy
measure: Level of breastfeeding self-efficacy
timeFrame: Postpartum 1st week
measure: Level of breastfeeding motivation
timeFrame: Postpartum 1st week
measure: Breastfeeding Process Evaluation Form
timeFrame: Postpartum 1st week
measure: Level of breastfeeding self-efficacy
timeFrame: Postpartum 8 st week
measure: Level of breastfeeding motivation
timeFrame: Postpartum 8 st week
measure: Breastfeeding Process Evaluation Form
timeFrame: Postpartum 8 st week
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Gozde Gokce Isbir
Study officials:
affiliation: Mersin University
name: Gozde Gokce Isbir
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03318913: Vascular Function, Fish Protein Hydrolysates and Type 2 Diabetes Mellitus
Official title: Effect of Acute Fish Protein Hydrolysates Ingestion on Vascular Function of the Type 2 Diabetes Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Vascular function
Type 2 diabetes mellitus
Fish protein hydrolysates
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease of abnormal carbohydrate metabolism which is related with high morbidity and mortality rates caused by its complications. One of the major diabetes-related arterial phenotypes thought to be responsible for development of cardiovascular disease is endothelial dysfunction. Nitric oxide (NO) is a potent molecule derived of endothelium, which plays key role in control of vascular tone. In T2DM present endothelial dysfunction due to reduced NO bioavailability. Fish protein hydrolysates (FPH) have been showed to present antioxidant peptides (and high value of ACE inhibition activity. Therefore, the present study aimed to examine whether single dose of FPH ingestion would reversal macro- and microvascular endothelial dysfunction in T2DM.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus

Exclusion Criteria:

* History of symptomatic coronary artery disease;
* Stroke or other known atherosclerotic disease;
* Cancer;
* HIV positive;
* Alcohol or drug abuse within the past 6 months previous the visit 1;
* use any antioxidant supplementation

Primary outcomes:
measure: Flow-mediated dilation
timeFrame: 60 min after nutritional intervention
measure: Near infrared spectroscopy
timeFrame: 70 min after nutritional intervention
measure: High performance liquid chromatography
timeFrame: 75 min after nutritional intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Macaé
country: Brazil
facility: Federal University of Rio de Janeiro
state: Rio De Janeiro
Study officials:
References:
Clinical trial NCT06938113: Ureteroscopy Combined With Negative Pressure Sheath Treatment of Kidney Stones
Official title: Efficacy and Safety of Flexible Ureteroscope Combined With Flexible Vacuum-assisted Sheath for Intelligent Pressure Control in the Treatment of Kidney Stones
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Kidney Calculi
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age range from 18 to 75 years old; Patients undergoing ureteral soft-scope surgery in our hospital due to high-load kidney stones; All enrolled patients received informed consent and signed informed consent before operation.

Brief summary: The removal rate, complication risk and operation time of ureteral soft scope combined with negative pressure suction sheath therapy for patients with high-load kidney stones (2-3cm) are still controversial. Therefore, what is the safety and effectiveness of ureteral soft scope combined with negative pressure suction sheath treatment for patients with high-load kidney stones and stones combined with infection? This study will help to solve the problems of safety and effectiveness of ureteral soft scope combined with negative pressure aspiration in the treatment of high-load kidney stones and kidney stones combined with infection, provide a more scientific treatment strategy for clinical practice, and promote the application of negative pressure aspiration technology in the field of ureteral soft scope lithotripsy, providing new means and ideas for individualized treatment.


Eligibility criteria: Inclusion Criteria:

150/5000

1. Patients diagnosed with kidney stones with a diameter of 2-3cm by CT;
2. Age \> 18 years old;
3. The anatomical structure of the kidney is normal, without deformity;
4. Unilateral or bilateral kidney stones are not treated at the same time
5. No serious heart and lung disease (ASA grade I-II)
6. Through preoperative communication, patients and their family members indicated that they were fully aware of the condition and the choice of treatment plan, and signed informed consent and informed choice notification;

Exclusion Criteria:

1. Simultaneous operation is required for ipsilateral ureteral calculi or contralateral upper or lower urinary calculi.
2. Severe coagulation dysfunction;
3. Previous history of ipsilateral upper urinary tract surgery;
4. Presence of urinary anatomic abnormalities or congenital malformations;
5. Patients who do not sign informed consent and cannot cooperate with the study;

Primary outcomes:
measure: Stone removal rate 1 month after surgery
timeFrame: From enrollment to 1 month after surgery
Secondary outcomes:
measure: Immediate stone free rate
timeFrame: From enrollment to 1 day after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05310513: The Predictors of ICU Admission of oPRES
Official title: The Predictors of ICU Admission of Obstetric Posterion Reversible Encephalopathy Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Posterior Reversible Encephalopathy Syndrome
Intensive Care Units
Lead sponsor: Guangzhou Medical University
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 366
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant Women diagnosed with PRES

Brief summary: The purpose of this study is to explore the predictors of ICU admission of obstetric posterior reversible encephalopathy syndrome.

Detailed description: The investigators retrospectively collected data (General information, clinical data, biochemical indicators, imaging features, and pregnancy outcome) from pregnant woman diagnosed with PRES to explore the predictors of ICU admission during 2012 to 2021.Then, the investigators grouped all the patients into ICU group and Non-ICU group according to ICU admission or not.

Eligibility criteria: Inclusion Criteria:

1. Pregnant Women were diagnosed of PRES.
2. all patients provided written informed consent

Exclusion Criteria:

1. patients combined with other neurological disorders
2. patients combined with mental illness

Primary outcomes:
measure: Blood Pressure(BP)
timeFrame: The BP of patients was obtained immediately at the onset of symptoms.
measure: severity of the edema
timeFrame: Cranial Imaging was examined immediately at the onset of symptoms, such as s headaches, visual changes, seizures, consciousness impairment.
measure: pregnancy outcomes
timeFrame: The pregnancy outcomes will record immediately when the patients deliver.
measure: biochemical parameters
timeFrame: Biochemical indicators were collected within 1 week of the hospital stay.
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Obstetrics and Gynecology, Key Laboratory for Major Obstetric Diseases of Guangdong Province, The Third Affiliated Hospital of Guangzhou Medical University
Study officials:
affiliation: The Third Affiliated Hospital of Guangzhou Medical University
name: Dunjin Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01280513: Effect of Increased Protein Intake on Colonic Metabolism
Official title: Influence of a Protein Diet on the Colonic Metabolism and Phosphorus Housekeeping in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Protein Fermentation
Toxicity in the Colon
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2011-01-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to modulate the protein fermentation and to investigate the effect on colon toxicity.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Regular eating pattern (3 meals/day)
* Age between 18 and 45 years old
* BMI between 18,5 and 30 kg/m²

Exclusion Criteria:

* Intake of antibiotics in the last month before the study
* Abdominal surgeries in the past (accept appendectomy)
* Consulting a dietician/following a diet
* Vegetarian
* Intake of pre- and/or probiotics
* Exposure to radioactivity in the year proceeding the study

Primary outcomes:
measure: Fecal water toxicity
timeFrame: Participants were followed for 5 weeks, with measurements on 3 specific time points
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KULeuven
state: Vlaams-Brabant
Study officials:
References:
citation: Windey K, De Preter V, Louat T, Schuit F, Herman J, Vansant G, Verbeke K. Modulation of protein fermentation does not affect fecal water toxicity: a randomized cross-over study in healthy subjects. PLoS One. 2012;7(12):e52387. doi: 10.1371/journal.pone.0052387. Epub 2012 Dec 20.
Clinical trial NCT00375713: Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema
Official title: A Multi-centre, Double-blind, Double-dummy, Randomized, Active-controlled Phase III Study to Evaluate the Efficacy and Safety of Xyzal® 5mg od vs Zyrtec® 10mg od in Subjects Aged 15 Years and Above With Dermatitis and Eczema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dermatitis
Eczema
Keywords: Dermatitis
Eczema
Pruritus
Xyzal
Zyrtec
Levocetirizine
Cetirizine
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-09-13
Enrollment: 466
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Korean double-blind non-inferiority study to asses the efficacy (as measured by the responder rate of pruritus severity score by the patient at visit 4 or end-of-treatment visit over the 2 weeks treatment period) and safety of Xyzal® to Zyrtec® in subjects suffering from dermatitis and eczema with pruritus symptoms


Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed as having atopic dermatitis, contact dermatitis, prurigo, pruritus in the dermatitis and eczema
* Subjects who require and agree to the concomitant use of a topical steroid preparation.
* Subjects having a minimum level of pruritus and having used topical hydrocortisone during the run -in period
* Written informed consent signed and dated by subject/legal guardian
* Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method and have a negative pregnancy test.

Exclusion Criteria:

* Subjects with a known hypersensitivity to cetirizine or levocetirizine
* Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
* Have used forbidden concomitant medications or having not respected adequate wash-out periods as defined by the protocol

Primary outcomes:
measure: Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score).
timeFrame: Day 7 and 14
Secondary outcomes:
measure: Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period
timeFrame: Baseline and at endpoint during the 14 day treatment period
measure: Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period
timeFrame: At endpoint during the 14 day treatment period
measure: Global Improvement at Endpoint During the 14 Day Treatment Period
timeFrame: At endpoint during the 14 day treatment period
Other outcomes:
Locations:
city: Gyeunggi-do
country: Korea, Republic of
city: Kyeonggi-Do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: UCB Pharma
name: Kevin Beh, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06056713: Hand Massage on Fatigue With Cancer Receiving Brachytherapy
Official title: The Effect of Hand Massage on Fatigue in Women With Cancer Receiving Brachytherapy Treatment
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hand Massage
Keywords: Hand Massage
Fatigue
Brachytherapy
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized controlled trial was designed to examine the effect of hand massage on the level of fatigue in patients receiving BT therapy. Randomized controlled trial was conducted in the radioterapi outpatient clinic of university hospital located in a large city in Turkey. When 12 patients were included in each group, it was determined that the power was 90% at the 5% Type I error level, and a total of 24 women with gynecological cancer were included in the study. The primary outcome of this study was the mean difference in fatigue scores between the groups following the three brachtherapy cycles hand intervention. Patient Information Form and Brief Fatigue Inventory (BFI) used. This study predicted that hand massage applied in each session, starting from the first session of brachytherapy application, would reduce the level of fatigue in women.

Detailed description: Therefore, this study aimed to compare the effects of hand massage intervention the level of fatigue in patients receiving BT therapy. . This randomized clinical trial was conducted.

Eligibility criteria: Inclusion Criteria:

* 18 years and over,
* underwent BT regularly
* Patients who volunteered to participate in the study

Exclusion Criteria:

* Having skin problems
* with metastases,
* have bleeding or coagulation disorders,
* using complementary integrated therapy during the study,
* Having edema or wound in the hand area,
* not wanting to get a massage
* Patients receiving general anesthesia during the procedure

Primary outcomes:
measure: Brief Fatigue Inventory (BFI)
timeFrame: The scale was filled in the baseline (after of the Hand massage).]
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Dilek Efe Arslan
state: Melikgazi
Study officials:
affiliation: ERCİYES UNİVERSİTY
name: DİLEK EFE ARSLAN, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00120913: Continuous Oral Contraceptives (COCs): Are Bleeding Patterns Dependent on the Hormones Given?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breakthrough Bleeding
Keywords: Breakthrough bleeding while taking continuously dosed oral contraceptives
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2005-07-19
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: While there may be a decrease in the total number of bleeding days women experience with continuous-dosed COCs (no menstrual withdrawal week), these regimens frequently result in an increased number of "breakthrough" or non-scheduled bleeding days. Breakthrough bleeding is among the main reasons cited for discontinuation of combined COCs dosed traditionally (3 weeks of active pill, 1 week of placebo) or continuously, and may offset the perceived benefit of fewer withdrawal bleeding events for many women taking continuous-dosed COCs. The exact mechanisms responsible for breakthrough bleeding patterns during hormonal contraception are unknown and may be related to the pill formulation. This study is to determine whether progestin type or estrogen dose influences bleeding patterns, side effects, or satisfaction with combined oral contraceptives (COC) dosed continuously.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 to 49 years old
* Good general health
* No medical contraindications to combined COC therapy.
* In addition, all participants were required to have taken cyclic COCs for at least three months at the time of enrollment, in order to avoid common transition bleeding with the initiation of COCs.

Primary outcomes:
measure: Bleeding patterns
Secondary outcomes:
measure: Satisfaction, menstrual-associated symptoms
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Alison B Edelman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: