louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04321564: Comparison of Beck Depression Score in Multipar and Nulliparous Women Who Have Gone Under Dilatation and Curettage
Official title: Comparison of Beck Depression Score in Multipar and Nulliparous Women Who Have Gone Under Dilatation and Curettage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Anxiety Depression
Pregnancy Early
Keywords: Beck Depression
Beck Anxiety
parite
curettage
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Comparison of beck depression and anxiety values of nulliparous and multiparous pregnants who underwent optional abortion below 12 weeks and the effect of parity on depression and anxiety.

Brief summary: It is aimed to compare the beck depression and anxiety values of the nulliparous and multipar pregnant women who undergo optional abortion below 12 weeks and to evaluate the effect of the parity on depression and anxiety.

Detailed description: The beck depression and anxiety scale consists of questionnaire questions asked to the patient, and the value on 17 indicates advanced depression.

The BDI inventory has maximum of 63 and minimum of 0 scores:

(0-10): Are considered normal ups and downs (11-16): Mild mood disturbance (17-20): Borderline clinical depression (21-30): Moderate depression, (31-40): Severe depression, Over 40: Extreme depression. A persistent score of !17, requires psychiatric treatment

Eligibility criteria: Inclusion Criteria:

* healthy
* Women with a pregnancy less than 12 weeks
* no psychiatric disease or drug use

Exclusion Criteria:

* Those who have had a psychiatric diagnosis before,
* Women under the age of 18,
* Psychiatric drug users,
* Those who have experienced a major trauma or disease
* During the 3-month follow-up period, who developed complications during the procedure pregnant again
* Women with a pregnancy greater than 12 weeks

Primary outcomes:
measure: Comparison of Beck Depression and Anxiety Scores in Multipar and Nulliparous Women who have gone under Dilatation and Curettage
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yalçın Bahat
state: İ̇stanbul
Study officials:
References:
Clinical trial NCT06475664: Colorectal Cancer Legal and Administrative Burden Support: A Pilot Clinical Trial
Official title: Colorectal Cancer Legal and Administrative Burden Support: A Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Colorectal Cancer
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single center single-arm, pilot study
Primary purpose: OTHER

Brief summary: This is a single center single-arm, pilot study of proactive and early connection with free legal care services for persons with advanced colorectal cancer to assess the feasibility, acceptability, and preliminary efficacy of this intervention in improving financial and psychosocial outcomes. Participants will receive free, personalized legal care services from Cancer Legal Care (CLC), a nonprofit organization located in the Twin Cities of Minnesota. The duration of study participation is 6 months, however, participants may continue to access free personalized legal care services beyond this period. All participants continue to receive standard of care as prescribed by their treating physician.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of advanced stage colorectal cancer.
* Estimated life expectancy of over 6 months in the opinion of the treating oncologist.
* 18 years of age or older at the time of consent.
* Able to understand, speak, read, and write in English.
* Able to provide voluntary written consent prior to the performance of any research related activity.

Exclusion Criteria:

* Lacks capacity to consent/has diminished capacity to consent.

Primary outcomes:
measure: The Perceived Stress Scale 4 (PSS-4)
timeFrame: baseline, 3 months, 6 months
measure: The Cancer Behavior Inventory-Brief Version (CBI-B)
timeFrame: baseline, 3 months, 6 months
measure: The COmprehensive Score for financial Toxicity (COST)
timeFrame: baseline, 3 months, 6 months
measure: The National Comprehensive Cancer Network's (NCCN) Distress Thermometer
timeFrame: baseline, 3 months, 6 months
measure: The Spitzer Uniscale (UNISCALE)
timeFrame: baseline, 3 months, 6 months
measure: Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I)
timeFrame: baseline, 3 months, 6 months
measure: Pearlin Mastery Scale
timeFrame: baseline, 3 months, 6 months
measure: The Life Engagement Test (LET)
timeFrame: baseline, 3 months, 6 months
measure: Rosenberg Self-Esteem (RSE) Scale
timeFrame: baseline, 3 months, 6 months
measure: Cancer Related Behavior Questionnaire
timeFrame: baseline, 3 months, 6 months
measure: Cancer Legal Care Services Questionnaire
timeFrame: baseline, 3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Arjun Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01133964: Dairy Proteins and Postprandial Appetite Regulation and Energy Expenditure
Official title: Dairy Proteins and Postprandial Appetite Regulation and Energy Expenditure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Dairy proteins
Appetite regulation
Energy expenditure
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Arla Foods
First posted: 2010-05-31
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The aim of this study is to examine the effect of dairy proteins (whey and casein) on postprandial appetite regulation and energy expenditure.

Detailed description: Several studies have shown that a high protein intake is associated with a increased loss of body weight and body fat as compared to a diet with a normal or low protein content. The effect seems to be due to a higher diet induced thermogenesis and increase satiety.

Milk has a high content of proteins. It contains two very different types of protein: whey and casein. Whey is a soluble protein whereas casein clots into the stomach, which delays its gastric emptying and thus probably results in a slower release of amino acids. It is therefore very likely that the two types of protein affect the thermogenesis and appetite regulation differently.

The aim of the present study is to examine the effect of dairy proteins (whey and casein) on postprandial energy expenditure, substrate oxidation and appetite regulation.

The study will have a cross-over design including four meals each including a test drink (milk, casein drink, whey drink or water).

Eligibility criteria: Inclusion Criteria:

* healthy males
* body mass index (BMI) 25-30 kg/m2
* 18-50 years
* weight stable

Exclusion Criteria:

* smoker
* regular use of medicine
* elitist athletes
* participation in other intervention studies

Primary outcomes:
measure: Subjective appetite sensation
timeFrame: 5 hours
measure: Energy expenditure
timeFrame: 5 hours
measure: Substrate oxidation
timeFrame: 5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department og Human Nutrition, Life, University of Copenhagen
Study officials:
affiliation: Department of Human Nutrition, Life, University of Copenhagen
name: Arne Astrup, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05275764: Comparison of the Efficacy of Intraocular Lens Optic Capture and In-the-bag Implantation Over 1 Year in Children With Congenital Cataract
Official title: Comparison of the Efficacy of Intraocular Lens Optic Capture and In-the-bag Implantation Over 1 Year in Children With Congenital Cataract
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Cataract
Intraocular Lens Implantation
Optic Capture
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with congenital cataracts who underwent primary or secondary intraocular lens implantation surgery at the Eye Hospital Affiliated to Wenzhou Medical University.

Brief summary: Approximately 30 eyes with congenital cataract who underwent primary or secondary intraocular lens implantation surgery at Zhejiang Eye Hospital from March 2018 to December 2020 were enrolled. According to the implantation method of IOL, patients were devided into the optic capture group and the endocapsular group. And through the clinical parameters of postoperative best corrected visual acuity (BCVA), intraocular pressure (IOP), IOL position and whether appear visual axis opacity to compare the outcome of the 2 IOL implantation methods.


Eligibility criteria: Inclusion Criteria:

* Children aged 1 to 10 years diagnosed with congenital cataract
* underwent I / II IOL implantation in our hospital
* corneal diameter more than 9mm
* Good compliance

Exclusion Criteria:

* Patients with other ocular or systemic diseases
* patients whose IOL cannot be implanted in or after the capsule due to ocular conditions
* Children with a history of other ocular surgery
* Low compliance

Primary outcomes:
measure: IOL position
timeFrame: through study completion, an average of 1 year
measure: BCVA
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
References:
Clinical trial NCT03523364: Survival Rate of All Ceramic Restorations Treated With Air-Water-Blasting Protocol
Official title: Long -Term Survival Rate of All Ceramic Restorations Cemented With Air-Water-Blasting Treatment Compared to Control Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Survival, Prosthesis
Lead sponsor: Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 131
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients treated for bonded all-ceramic restorations between years 2003-2014

Brief summary: This study evaluates retrospectively the survival rate of all-ceramic restorations, cemented using AWB technique (test) compared to those cemented with conventional technique (control)

Detailed description: A retrospective study on ceramic restorations, placed in the period 2003-2014, will be performed to assess the survival rate of all-ceramic restorations cemented adhesively. The effectiveness of cementation largely depend on the method used. The Air-Water-blasting performed prior to conventional acid-etch of dental tissues offers an increase in bond strength compared to the conventional etching technique.

Eligibility criteria: Inclusion Criteria:

* patients who received at least one ceramic restoration

Exclusion Criteria:

* patients who received feldspathic ceramic restorations

Primary outcomes:
measure: survival rate
timeFrame: 2003-2014
Secondary outcomes:
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Dipartimento di Scienze Mediche Orali e Biotecnologiche
state: CH
Study officials:
affiliation: University of Chieti-Pescara
name: Tonino Traini, DDS; PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van den Breemer CR, Vinkenborg C, van Pelt H, Edelhoff D, Cune MS. The Clinical Performance of Monolithic Lithium Disilicate Posterior Restorations After 5, 10, and 15 Years: A Retrospective Case Series. Int J Prosthodont. 2017 Jan/Feb;30(1):62-65. doi: 10.11607/ijp.4997.
citation: Beier US, Kapferer I, Dumfahrt H. Clinical long-term evaluation and failure characteristics of 1,335 all-ceramic restorations. Int J Prosthodont. 2012 Jan-Feb;25(1):70-8.
Clinical trial NCT03047564: Metal Ion Concentration Between Coated and Uncoated TKA
Official title: Metal Ion Concentration and Clinical Outcome Between Coated and Uncoated TKA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Total Knee Arthroplasty
Total Knee Replacement
Outcome
Metal ion concentration
Results
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Mathys Ltd Bettlach
First posted: 2017-02-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to one of two implants
Primary purpose: TREATMENT

Brief summary: Metal ion release from metal implants may have side effects. It can be reduced by coating of the implant. This study compares coated and uncoated TKA.

Detailed description: Patients are randomized to receive a coated or uncoated TKA. Patients are assessed before surgery, after 3 month, 1 year and 5 years.

Blood samples are collected in 7.5 ml S-Monovette® tubes (for trace metal analysis, Sarstedt AG, Germany) using a specific steel needle for trace metal analysis (Sarstedt AG, Germany). Within one hour, plasma was separated by centrifugation at 2500g for ten minutes. Samples were stored at -20°C before being analysed for chromium, cobalt, molybdenum and nickel content using a graphite furnace atomic absorption spectrometer Z-8270 with Polarisation-Zeeman-Absorption (Hitachi Ltd., Japan). The accuracy and precision of the method is validated to \< 10% using the control materials SeronormTM Trace Elements Serum (SERO AS, Norway). The detection limit of the method is estimated at 0.5µg/l for chromium, cobalt and molybdenum, 1.0µg/l for nickel (mean + 3 standard deviations from buffer). All probes having ion levels below the detection limit were adjusted to 0.25µg/l for chromium, cobalt and molybdenum and 0.5µg/l for nickel.

Clinical outcome is measured with the Knee Society Score, Oxford Knee Score, Short-Form 36 and University of Los Angeles Activity Score.

Eligibility criteria: Inclusion Criteria:

* indication to TKA
* no other metal implant

Exclusion Criteria:

* no informed consent
* not able to understand study and/or questionnaires
* Need of a higher constrained implant

Primary outcomes:
measure: Metal Ions (Cobalt, Chromium, Molydenum, Nickel)
timeFrame: before surgery, 1 year, 5 years
Secondary outcomes:
measure: Function
timeFrame: before surgery, 3 month, 1 year, 5 years
measure: Patient Reported Outcome
timeFrame: before surgery, 3 month, 1 year, 5 years
measure: Health-related Quality of Life
timeFrame: before surgery, 3 month, 1 year, 5 years
measure: Activity
timeFrame: before surgery, 3 month, 1 year, 5 years
Other outcomes:
measure: Adverse Events
timeFrame: through study completion, in average 5 years
Locations:
Study officials:
affiliation: University Hospital Carl Gustav Carus
name: Jörg Lützner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02180464: A Intra-individual Comparison to Investigate the Efficacy and the Safety of LAS41004 Formulation in Mild to Moderate Psoriasis
Official title: A Phase IIa, 28-day Treatment, Multi-center, Randomized, Comparator-controlled, Observer-blind Trial With Intra-individual Left/Right Comparison to Investigate the Anti-psoriatic Efficacy and the Safety of an LAS41004 Formulation in Comparison to an Active Reference in Patients With Mild to Moderate Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: psoriasis, topical
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2014-07-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Proof-of concept study to competitively investigate antipsoriatic efficacy and safety of a LAS41004 formulation vs active control No formal study hypothesis, but descriptive evaluation (PoC).


Eligibility criteria: Inclusion Criteria (main):

* mild to moderate stable chronic plaque-type psoriasis with at least two symmetrical lesions with a treatment area of 20 - 300 cm² and a TSS of ≥ 6;

  * female volunteers of childbearing potential\* must agree to use appropriate and reliable methods of contraception
  * written informed consent obtained.

Exclusion Criteria (main):

* severe forms of psoriasis or forms of psoriasis other than chronic plaque psoriasis,
* treatment with any locally acting medications which might counter or influence the trial aim within 2 weeks preceding the treatment phase of the trial and during the trial;
* treatment with any systemic medications which might counter or influence the trial aim or phototherapy/PUVA within 4 weeks preceding the treatment phase of the trial and during the trial;
* treatment with vitamin A supplements;
* treatment with any biologics within 3 months preceding the treatment phase of the trial and during the trial, or in the case of ustekinumab, within 6 months;
* treatment with any immunosuppressive medication within 6 months preceding the treatment phase of the trial and during the trial;
* known allergic reactions, irritations or hypersensitivity to the active ingredients
* contraindications according to summary of product characteristics (SmPC) of the active comparator: - pregnancy or nursing;

Primary outcomes:
measure: Total symptom score
timeFrame: day 28 vs baseline
Secondary outcomes:
measure: Total symtom score (during study performance)
timeFrame: Days 4, 8, 15, and 22
measure: Physician's global assessment (PGA)
timeFrame: Days 1, 4, 8, 15, 22 and 29
measure: Physician's global tolerability assessment (PGTA)
timeFrame: 4, 8, 15, 22 and 29
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Site 1
Study officials:
affiliation: bioskin, Hamburg
name: Walter Wigger-Alberti, Dr med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00784264: A Study on Intima Media Thickness (IMT) in Middle-aged Subjects
Official title: A Study on Intima Media Thickness (IMT) in Middle-aged Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Keywords: Asymptomatic atherosclerosis
Intima media thickness (IMT)
central obesity
cardiovascular disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-11-02
Enrollment: 200
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: aged 55 or above with central obesity, male more than 90 cm; female more than 80 cm

Brief summary: This is an observational study to measure the thickness of artery walls in the neck (intima media thickness IMT) by ultrasound examination in middle-aged subjects with central obesity. The purpose of this study is to obtain local data how common asymptomatic atherosclerosis is, and to investigate the association between Cardiovascular Disease risk factors and intima media thickness (IMT) in the Hong Kong population. Results from this study may enhance the public awareness of asymptomatic atherosclerosis and understand its role in the development of Cardiovascular Disease in Hong Kong.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 55 years or above.
* Waist circumference: male more than 90 cm; female more than 80 cm.

Exclusion Criteria:

* Any known chronic diseases requiring long-term medication such as hypertension, diabetes and hyperlipidemia.
* Presence of known cardiovascular diseases including cerebro-vascular disease, coronary heart disease and peripheral artery disease.
* Presence of any active major diseases that may interfere the physical conditions and body weight of subjects during the study period, which include malignancy, infection, renal or liver function impairment, recent major surgery (within 3 months).

Primary outcomes:
measure: To investigate the prevalence of asymptomatic atherosclerosis by measurement of intima media thickness (IMT) in middle-aged subjects with central obesity in Hong Kong,
timeFrame: during the one single study visit
Secondary outcomes:
measure: To examine the association between IMT value and cardiovascular disease (CVD) risk factors, and blood lipid and glucose profiles in middle-aged centrally obese subjects in Hong Kong.
timeFrame: During the one single study visit
measure: IMT results to be compared with what being reported in the recent literature on normal Chinese population.
timeFrame: During the one single study visit
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Research Site
Study officials:
affiliation: AstraZeneca Hong Kong Ltd
name: Karen Yuen
role: STUDY_DIRECTOR
affiliation: Prince of Wales Hospital, Shatin, Hong Kong
name: Chun chung Chow, MD
role: PRINCIPAL_INVESTIGATOR
References: