louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01932853: Association Between Dose Dialysis by Kt and Mortality
Official title: Evaluation of the Association of Dialysis Dose Obtained by Kt and Mortality in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Hemodialysis Patients
Lead sponsor: NephroCare Spain
Sponsor class: INDUSTRY
First posted: 2013-08-30
Enrollment: 6129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study subjects:

Patients\> 18 years in hemodialysis treatment at any FMC center of Spain that meet the inclusion criteria.

Data will be collected according to clinical practice and patients will be categorized according to their dose of Kt, along the two years of the study. Will seek the association of dialysis dose with mortality and hospitalization

Brief summary: The aim of this study is to assess whether patients receiving current recommendations of an adequate dialysis dose by Kt adjusted for body surface area improved survival at 24 months compared to those who do not get it, as well as assess whether patients receiving a dose greater obtain more benefit.


Eligibility criteria: Inclusion Criteria:

* \> 18 years old
* \> six months on hemodialysis
* Receiving 3 sessions of dialysis per week
* Having 5 or more valid measures of Kt during the month

Exclusion Criteria:

* active chronic inflammatory diseases
* Liver cirrhosis
* Neoplasms
* Chronic immunosuppression or use of anti-inflammatory

Primary outcomes:
measure: Mortality
timeFrame: two years
Secondary outcomes:
measure: Hospitalization
timeFrame: two years
Other outcomes:
measure: Mortality and hospitalization cause
timeFrame: two years
Locations:
city: Madrid
country: Spain
facility: NephroCare Spain
Study officials:
affiliation: Servei Nefrologia, ICNU, Hospital Clínic.
name: Francesc Maduell, MD, Ph
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03439553: Estimating the Short-term Effectiveness of Online Advertisements for Improving Health
Official title: Estimating the Short-term Effectiveness of Online Advertisements for Improving Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia
Obesity
Smoking Cessation
Lead sponsor: Microsoft Research
Sponsor class: INDUSTRY
Collaborators: name: Schneider Children's Medical Center, Israel
name: Interdisciplinary Center Herzliya
First posted: 2018-02-20
Enrollment: 2000000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Bing ads designed to encourage people to adopt healthier practices (e.g., stop smoking, become physically active, stop consuming harmful content) are shown using the advertising system, to test which ads are more effective as apparent in the subsequent queries to Bing submitted by users who saw the ads.


Eligibility criteria: Inclusion Criteria:

* Use of the Bing ad system with target phrases.

Exclusion Criteria:

* None

Primary outcomes:
measure: The number of people who increase and the number of people who decrease searches for positive target behaviors post intervention, compared to prior to the intervention, or a similar decrease in negative behaviors
timeFrame: Up to 1 month after the intervention
Secondary outcomes:
measure: Clickthrough rates
timeFrame: During the intervention itself and up to 1 minute after the intervention (advertisement display).
Other outcomes:
Locations:
city: Herzliya
country: Israel
facility: Microsoft Research Israel
Study officials:
References:
citation: Yom-Tov E, Brunstein-Klomek A, Mandel O, Hadas A, Fennig S. Inducing Behavioral Change in Seekers of Pro-Anorexia Content Using Internet Advertisements: Randomized Controlled Trial. JMIR Ment Health. 2018 Feb 22;5(1):e6. doi: 10.2196/mental.8212.
Clinical trial NCT04181853: The Effect of Aerobic Exercise on Genetic Molecules
Official title: The Effect of Aerobic Exercise on Genetic Molecules Related With Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Aerobic Exercise
Genetic Response
Keywords: Type 2 diabetes mellitus
exercise
aerobic
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2019-12-02
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study has 3 arms
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to compare the effects of high intensity interval exercise and moderate intensity continuous exercise on some genetic molecules in patients with type 2 diabetes mellitus.

Detailed description: Volunteers with type 2 diabetes mellitus will be evaluated in terms of any contra-indication that will restrain them from making exercise. 90 male or female volunteers who are suitable in terms of inclusion/exclusion criteria will be invited for the study. Volunteers will be randomly distributed to one of the 3 groups. Each group will contain 30 participants. 1. group will make aerobic exercise which is in the form of high intensity interval exercise 2.group will make aerobic exercise which is in the form of moderate intensity continuous exercise 3. Control group. Exercise groups will be cycling under observation in the hospital setting. Control group will make simple stretching exercises at home. Participants will be requested to complete a 3 months of exercise. They will be evaluated before and at the end of the 3 months of exercise with blood tests to measure genetic molecules related with metabolism.

Eligibility criteria: Inclusion Criteria:

Clinica diagnosis of type 2 Diabetes mellitus less than 10 years and more than 1 year.

* must have appropriate medical therapy and diet.
* must not be treated with insulin.
* must be exercising less than 210 minutes/ week

Exclusion Criteria:

* prominent cardiovascular disease
* coronary artery disease
* moderate to severe valvular disease
* atrial fibrillation
* untreated hypertension
* congenital heart disease
* retinopathy
* neuropathy
* macro albuminuria
* cerebrovascular disease
* ejection fraction less than 40
* body mass index greater than 35.
* prominent ischemic changes in EKG at rest or during exercise.
* cigarette or alcohol addiction
* on drugs that interferes with body fat distribution (such as insulin, thiazolidinediones

Primary outcomes:
measure: genetic molecules
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University,Medical Faculty, PMR Department
name: Gulin Findikoglu, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01302353: Phase I Trial of Emulsified Isoflurane
Official title: Phase I Trial of Emulsified Isoflurane in Adult Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adverse Effect of Intravenous Anesthetics
Keywords: Phase I trial
Emulsified Isoflurane
Health volunteer
Lead sponsor: Sichuan University
Sponsor class: OTHER
First posted: 2011-02-24
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this trial, our primary goal is to investigate the safety of intravenous infusion of emulsified isoflurane. In order to protect volunteers, the investigators adopt the modified Fibonacci dose-escalation, starting from a very low dose which is derived from the 1/600 of acute LD50 in pre-clinic study. The trial will be terminated if half of volunteers develop severe adverse event in any dose group or any volunteer develop fatal adverse event in any group.


Eligibility criteria: Inclusion Criteria:

* Age 18\~45 years old (50:50 male:female) healthy volunteer;
* Body Mass Index (BMI) 19\~24;
* health volunteers assessed by medical history and physical examination

  * systolic blood pressure between 100\~140mmHg;
  * heart rate between 60\~100bpm;
  * pulse oxygen saturation \> 97% when inspiring air and reaching 100% after inspiring 100% oxygen for 5 min;
  * with normal result for routine lab test, including complete blood count, chemical test, urine test and stool test;
* Non-smoker and no history of alcohol or drug abuse;
* Fully understand the whole process of this trial and sign the informed consent.

Exclusion Criteria:

* Any history of allergy, especially to isoflurane or intralipid;
* Any suspected history of malignant hyperthermia in the volunteer or his/her relatives;
* Recent use of a medication with a pronounced effect on the central nervous system or any other organ (within 3 month)
* Recent participation in other clinical trial (within 1 month)
* Any history of difficult airway or suspected difficult airway;
* Pregnancy;
* Hyperlipidemia.

Primary outcomes:
measure: Vital Signs
timeFrame: after drug infusion to 24 hours after infusion
Secondary outcomes:
measure: Efficacy of emulsified isoflurane as an intravenous anesthetics
timeFrame: immediate from drug infusion, up to 24 hours after infusion
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Institute of Drug Clinical Trial• GCP Center,West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: Department of Anesthesiology, West China Hospital, Sichuan University
name: Jin Liu, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02303353: Data Base Project for Acquisition of Cancer Patient Data in Practices and Ambulant Therapy
Official title: Data Base Project for Acquisition of Cancer Patient Data in Practices and Ambulant Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma
Keywords: Breast cancer
Ovarian cancer
Lung cancer
Colon cancer
Gastric cancer
Pancreatic cancer
Rectum cancer
Plasmacytoma
Lead sponsor: SPGO Research Mannheim GmbH
Sponsor class: INDUSTRY
Collaborators: name: AKP Freiburg GmbH
First posted: 2014-11-27
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from carcinoma which are treated in practices (ambulant therapy)

Brief summary: The purpose of this registry is to evaluate the situation regarding ambulant therapy of cancer patients in different practices in Germany. It should provide insight into the implementation of schemes for cancer therapy predefined in the guidelines, the treatment of diverse adverse reactions and the counter measures taken. Thereby, potential differences in treatment and with that differences in quality amongst individual practices might be identified. The medium to long term aim is to contribute to positively influence the quality of medical care of cancer patients in Germany.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Tumor disease (carcinoma of either breast, ovary, lung, colon, stomach, pancreas, rectum or plasmacytoma)
* Written informed consent

Exclusion Criteria: none

Primary outcomes:
measure: Anti-cancer treatments (Course of the disease and type of applied anti-cancer therapies. Assessment of guidelines' implementation)
timeFrame: From date of ICF until date of cure/death/ICF withdrawal, up to 60 months
Secondary outcomes:
measure: Adverse reactions and their treatment (Number and type of adverse reactions and applied counter measures / therapies)
timeFrame: From date of ICF until date of cure/death/ICF withdrawal, up to 60 months
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Practice
Study officials:
References:
Clinical trial NCT06744153: Clinical Outcomes of Functional Space Maintainers Designed Using CAD/CAM Technology in Early Loss of the First Primary Molar
Official title: Innovative Functional Space Maintainers Designed Using CAD/CAM Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Crowns
Orthodontics, Interceptive
Orthodontic Appliance
Keywords: functional space maintainers
CAD/CAM
3D printing
Milling
Lead sponsor: University of Kragujevac
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 28
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: As passive fixed space maintainers do not replace the lost tooth and therefore do not provide a chewing function, this study aims to evaluate the efficiency of an innovative solution for maintaining space after the premature extraction of first primary molars using functional space maintainers based on CAD/CAM technology.

Detailed description: The innovative design of a functional space maintainer named KOS\&MET (Key Orthodontic System and Materials Enhanced Therapy) was created using 3Shape Dental Designer (3Shape A/S, Copenhagen, Denmark). The functional maintainer features an intraoral window for monitoring the eruption of the successor tooth. In addition to its role in maintaining space, the maintainer is designed to restore bilateral chewing function. In addition to the loop encircling the second primary molar, the space maintainer includes a crown for the missing first primary molar. To achieve optimal anatomical details, we applied a mirror model of the molar from the contrary side.

Space maintainers were fabricated using CAD/CAM technology in two ways: 3D printing and milling.

1. 3D Print (Metal) - Additive Method: In this group, the functional space maintainer was fabricated from a metal alloy (Co 69%, Cr 25%, W 9.5%, Mo 3.5%, Si 1%, Scheftner, Germany) using a 3D printer (MySint100 Dual Laser, Italy).
2. Milling (Composite) - Subtractive Method: A dental milling machine (Wieland Zenotec Select Hybrid, Germany) was used to fabricate functional space maintainers from a polymer composite material (breCAM.HIPC, Bredent, Germany).

Eligibility criteria: Inclusion Criteria:

* Indication for extraction or premature loss of the first primary molar in the upper or lower jaw.
* A prolonged time period from the loss of the primary tooth to the eruption of its successor (with bone tissue present above the successor tooth on the radiograph).
* A complete dental arch on the contrary side of the jaw.
* Intact or adequately restored vital second primary molars in the region indicated for the placement of a space maintainer.

Exclusion Criteria:

* Systemic disorders and uncooperative children.

Primary outcomes:
measure: Clinical Evaluation - Fractures and decementing
timeFrame: 6 months
Secondary outcomes:
measure: Bite Force (Newtone)
timeFrame: 1 Day
Other outcomes:
Locations:
city: Kragujevac
country: Serbia
facility: Faculty od Medical Sciences University of Kragujevac
Study officials:
References:
Clinical trial NCT01211353: Personalized Drinking Feedback Interventions
Official title: Personalized Drinking Feedback Interventions for OEF/OIF Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Keywords: Alcohol
Brief Intervention
Personalized Feedback
Veterans
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2010-09-29
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this research is to better understand how to reduce hazardous drinking among OEF/OIF veterans by assessing the effectiveness of a low-cost, computer-delivered preventative program.

Detailed description: Excessive drinking among OEF/OIF veterans represents an important public health problem for both the veterans themselves and those with whom they interact. The objective of this research is to better understand how to reduce hazardous drinking among this group by assessing the effectiveness of a low-cost, computer-delivered preventative program. It is hypothesized that an intervention that provides personalized feedback about drinking behaviors will be more effective than an education-only control condition at reducing alcohol use and negative alcohol-related consequences.

Eligibility criteria: Inclusion Criteria:

* OEF/OIF Veteran

Exclusion Criteria:

* None

Primary outcomes:
measure: Daily Drinking Questionnaire
timeFrame: Past 30 Days
Secondary outcomes:
measure: Short Inventory of Problems
timeFrame: Past 6 Months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Harry S Truman Memorial VA Medical Center
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Mattjew P Martens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06179953: Emotional Skills Training with Social Robot
Official title: Evaluate the Effect of Social Robot Mediation on the Development of Emotional Skills
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: autism
children
emotional skills
social robot
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
Collaborators: name: Messina, Italy
First posted: 2023-12-22
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Autism is a neurodevelopmental disorder that involves difficulties especially in the sphere of social interaction, social communication, and restricted and stereotyped behavior patterns.

In particular, emotional regulation is a central developmental skill. In fact, the emotional dysregulation observed in children with autism results in increased social and behavioral difficulties over time.

Therefore, the present protocol aims to test the role of a human-assisted social robot as a mediator of social-emotional understanding intervention for children with autism spectrum disorders (ASD).

The children, will be divided into two groups, an experimental one in which training will be conducted through the use of social robot and control group which will be conducted through traditional therapy.


Eligibility criteria: Inclusion Criteria:

* Language in sentences
* use of connectors
* ability to narrate events not present
* ADOS level: module 2
* Griffiths: QS\>75

Exclusion Criteria:

* presence of other medical disorders

Primary outcomes:
measure: Test of Emotional Vocabulary
timeFrame: The administration has a duration of 15 minutes.
measure: Test of emotion comprehension
timeFrame: The administration has a duration of 15-20 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Study officials:
affiliation: Istituto per la Ricerca e l'Innovazione Biomedica
name: Flavia Marino
role: PRINCIPAL_INVESTIGATOR
References:
citation: American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.) https://doi.org/10.1176/appi.books.9780890425596.
citation: Berkovits, L., Eisenhower, A. e Blacher, J. (2017). Regolazione delle emozioni nei bambini piccoli con disturbi dello spettro autistico. Giornale di autismo e disturbi dello sviluppo, 47(1), 68-79.
Clinical trial NCT00833053: Dose Optimization of Infliximab in Moderate to Severe Plaque Psoriasis (Study P05315)
Official title: A Study of Dose Optimization of Infliximab in the Treatment of Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-01-30
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Participants from an ongoing observational study (P05319) who have a limited (adequate but less than optimal) response to infliximab will be randomized to either increase the frequency of infliximab infusions from every 8 weeks to every 6 weeks, or to add weekly methotrexate to their current treatment plan. While receiving infliximab study treatment(s), patients in this study will attend regularly scheduled office visits for various clinical tests for safety and effectiveness evaluations.


Eligibility criteria: Inclusion Criteria:

* Subjects must have a diagnosis of moderate to severe plaque-type psoriasis and have had participated in Study P05319.
* Subjects must have demonstrated an adequate but suboptimal response to infliximab in Study P05319
* Subjects must be at least 18 years old
* Subjects must be candidates for phototherapy or systemic treatment for psoriasis.
* Subjects must not be pregnant and must meet contraceptive requirements
* Subjects must meet tuberculosis screening criteria
* Subjects must meet laboratory and medical history screening requirements

Exclusion Criteria:

* Subjects for whom infliximab or methotrexate is contraindicated or not recommended.
* Subjects already using certain investigational, biological, or immunosuppressive drugs
* Subjects with certain comorbid conditions
* Subjects who currently have or have a history of certain infections
* Subjects who have recently received live virus or bacterial vaccinations
* Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.

Primary outcomes:
measure: Number of Participants With A Psoriasis Area and Sensitivity Index (PASI)-75 Response at Week 28
timeFrame: Baseline, Week 28
Secondary outcomes:
measure: Number of Participants With A PASI-50 Response at Week 28
timeFrame: Baseline, Week 28
measure: Number of Participants With A PASI-90 Response at Week 28
timeFrame: Baseline, Week 28
measure: Number of Participants With A PASI-100 Response at Week 28
timeFrame: Baseline, Week 28
measure: Change From Baseline in Mean Participant Raw PASI Scores at Week 28
timeFrame: Baseline, Week 28
measure: Dermatology Life Quality Index (DLQI) at Week 28
timeFrame: Week 28
measure: Euro-Qol 5 Dimension (EQ-5D) Change From Baseline at Week 28
timeFrame: Baseline, Week 28
Other outcomes:
Locations:
Study officials:
References: