louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00226980: A Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma
Official title: A Phase II Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Neoplasms
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2005-09-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma and also to determine the safety of the combination.


Eligibility criteria: Inclusion Criteria:- Able to comprehend and sign an IRB approved Informed consent

* Willingness and ability to comply with the FDA-mandated S.T.E.P.S.® program.
* Male or female 18 years or older
* Willing to use contraception
* Pathologic diagnosis of renal cell carcinoma
* Bi-dimensionally measurable disease
* Evidence of disease progression prior to start of treatment
* Failed prior immunotherapy or unwilling/unable to receive prior immunotherapy
* Adequate hematologic data: ANC.1.5; platelets\>100x10\^9
* Adequate renal function: Creatinine clearance .50cc
* Adequate liver function: Alkaline phos \<3XULN AST/ALT \<3XULN T.Bili \<1.5XULN
* ECOG performance status 0-1 Exclusion Criteria:- Known brain metastases.
* Peripheral neuropathy.
* Pregnant and/ or lactating female.
* Unable to take a baby aspirin.

Primary outcomes:
measure: Efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma.
Secondary outcomes:
measure: Safety of the combination
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Dr. Sandy Srinivas
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04514380: Effect of Drinking Carbohydrate-containing Fluids on Gastric Residual Volume in Elderly Patients
Official title: Ultrasound Assessment of Gastric Volume in Elderly Patients Undergoing Total Knee Arthroplasty After Drinking Carbohydrate-containing Fluids: A Prospective Observational Non-randomized Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fasting
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 64
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing total knee arthroplasty

Brief summary: In the past, some guidelines advised no oral intake for at least 8 hours before any surgery. However, research has shown risks associated with excessive fasting, such as postoperative insulin resistance, and advantages in shorter fasting protocols, such as reduced postoperative nausea and vomiting.

The perioperative fasting guidelines of the European Society of Anaesthesiology focus on preoperative carbohydrates. They hold that it is safe for patients to drink carbohydrate-rich fluids up to 2 hours before elective surgery and that drinking carbohydrate-rich fluids improves subjective well-being, reduces thirst and hunger, and reduces postoperative insulin resistance at an evidence level of 1++. Nevertheless, data on drinking carbohydrate fluids before surgery in elderly patients are limited.

In our institution, there are two clinical pathways for total knee arthroplasty according to the surgeons. One difference is whether carbohydrate fluids drink or not before surgery. The purpose of this study, therefore, is to assess gastric volume in fasted elderly patients using ultrasound after they drank carbohydrate fluids 2 hours before surgery and to compare with matched patients using age, body mass index, and comorbidity, who did not drink carbohydrate fluids before surgery.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing total knee arthroplasty
* Age: 65\~85 yeas
* ASA 1\~3

Exclusion Criteria:

* Age \< 65 years
* ASA \>= 4
* Diabetes mellitus
* Chronic kidney disease

Primary outcomes:
measure: Gastric volume
timeFrame: During the gastric volume measuring at preoperative holding area/ an average of 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National Univ. Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Hyo-Seok Na, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shin HJ, Koo BW, Lim D, Na HS. Ultrasound assessment of gastric volume in older adults after drinking carbohydrate-containing fluids: a prospective, nonrandomized, and noninferiority comparative study. Can J Anaesth. 2022 Sep;69(9):1160-1166. doi: 10.1007/s12630-022-02262-9. Epub 2022 Apr 21.
Clinical trial NCT02639780: Biochemical Alterations of Stored Erythrocyte Membranes
Official title: Biochemical Alterations of Stored Erythrocyte Membranes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Medical Scientific Fund of the Mayor of Vienna
name: European Society of Anaesthesiology
First posted: 2015-12-24
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: volunteers who will donate one unit of packed red blood cells

Brief summary: The investigators will define procoagulant properties of packed red blood cells and investigate whether packed red blood cells from certain donor populations are prone to induce procoagulant states.


Eligibility criteria: Inclusion Criteria:

* group 1: healthy female volunteers 18-35 y.o.
* group 2: healthy male volunteers 18-35 y.o.
* group 3: healthy female volunteers 36-60 y.o.
* group 4: healthy male volunteers 36-60 y.o.
* group 5: female volunteers 36-60 y.o., BMI 26-45
* group 6: male volunteers 36-60 y.o., BMI 26-45

Exclusion Criteria:

* age below 18 years
* age above 60 years

Primary outcomes:
measure: protein expression pattern
timeFrame: week 0
measure: protein expression pattern
timeFrame: week 2
measure: protein expression pattern
timeFrame: week 4
measure: protein expression pattern
timeFrame: week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT05850780: Clinical and Radiographic Evaluation of Laser Photobiomodulation Pulpotomy of Primary Molars in Children
Official title: Clinical and Radiographic Evaluation of Laser Photobiomodulation Pulpotomy of Primary Molars in Children (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulpitis
Pulpotomy
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 52
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the clinical and radiographic outcomes of photobiomodulation pulpotomy compared to MTA pulpotomy in primary molars in children.


Eligibility criteria: Inclusion Criteria:

* Children with dental behavior score of 3 or 4 according to the Frankel behavior rating scale.
* Patients whom their maxillary primary molars are indicated for pulpotomy and SSC restoration.
* Lack of history of allergy to the materials used for anesthesia and sulfite.
* Children free of any systemic disease or special health care needs (ASA 1).
* Completion of the written informed consent form by parents/guardian.

Exclusion Criteria:

* Children who receive any analgesic drugs at least 24 hours before treatment.
* Any inflammation or lesion in the injection site
* Patients who have previous bad experience of dentistry were excluded to eliminate the possible impact of the child's previous painful or stressful experiences
* Child coming for emergency treatment of pain.
* If hemostasis is not achieved within five minutes after application of moist cotton pellet directly to the pulp stumps
* If radicular pulp tissue was not vital due to the presence of suppuration or purulent necrosis (pus discharge).

Primary outcomes:
measure: Clinical success of pulpotomy
timeFrame: up to 12 months
measure: Radiographic success of pulpotomy
timeFrame: up to 12 months
measure: Tissue healing
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Aliaa Hamouda, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Amani Khalil, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Laila El-Habashy, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03614780: Pre Post Evaluation of Temperature, Steps, and Glucose With Additional Time Spent Outdoors in an Urban and Rural Setting
Official title: Environmental Exposures Across Urban and Rural Communities in the Deep South
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temperature
Exercise
Diabetes Mellitus, Type 2
Keywords: rurality
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2018-08-03
Enrollment: 180
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This research was designed with partners to determine differences in temperature exposures in urban and rural communities in Alabama. The investigators hypothesized that significant differences in temperature exposure exist between urban and rural settings. Time spent outdoors has been previously positively associated with greater physical activity. Built environment components in urban versus rural environments and ambient temperatures experienced during the summer may pose barriers to time spent outdoors. Persons with Type II Diabetes Mellitus may find it more difficult to overcome temperature barriers due to reduced thermoregulation capacity. This analysis will result in a more precise picture of temperature exposure as well as behavioral factors that may mediate exposure.

Detailed description: The investigators gathered individual-level temperature exposure data by asking 180 female participants to wear a small thermometer on their shoe for 7 days. Ninety participants were recruited from Birmingham AL (urban) and 90 from rural West Central Alabama. The first two days participants were asked to go about their normal daily activities. During the next 5 days of participation, participants were asked to add an additional 30 minutes of time spent outdoors. As a secondary outcome, steps were measured via pedometers worn by participants. A subgroup of participants with self-reported doctor diagnosed Type II Diabetes also recorded their fasting glucose each morning of participation.

Eligibility criteria: Inclusion Criteria:

* Female, age 19 to 65, willing to wear a small thermometer on shoe and pedometer on waist for one week.

Exclusion Criteria:

* Medical condition that limits the amount of time able to be spent outdoors.

Primary outcomes:
measure: temperature
timeFrame: 7 days
Secondary outcomes:
measure: steps
timeFrame: 7 days
measure: fasting glucose
timeFrame: 7 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Center for the Study of Community Health
state: Alabama
Study officials:
affiliation: Virginia Polytechnic Institution and State University
name: Julia M Gohlke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05977062: Optimization of an Online Stepwise Therapeutic Device Based on a Cognitive-behavioral Approach for Cancer Patients With Insomnia
Official title: Sleep-4-all-2.0 Study: Optimization of an Online Stepwise Therapeutic Device Based on a Cognitive-behavioral Approach for Cancer Patients With Insomnia - A Prospective Real-life Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Insomnia
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Determine who can benefit from additional follow-up by a professional and what type of help is most appropriate (need and expectation of patients in terms of support by a health professional)


Eligibility criteria: Inclusion Criteria:

* Adults patients,
* With a diagnosis of localized or metastatic cancer,
* During or after their treatment,
* In one of the following three cancer centres: Gustave Roussy (Villejuif), Montpellier Cancer Institute (Montpellier), and Léon Bérard Center (Lyon)
* With a significative score on the self-screening Insomnia Severity Index score (ISI ≥ 8)
* Able to readily read and understand French,
* Able to use informatic tools confidently and with Internet access,
* Who have signed the online consent form,
* Affiliated to a social security system or beneficiary of the same.

Exclusion Criteria:

* Patient with a visual, hearing or cognitive disability that is incompatible with the study,
* Simultaneous participation in another study evaluating a treatment of insomnia,
* Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.

Primary outcomes:
measure: Evolution of the ISI score
timeFrame: until 24 weeks after enrolment
measure: Patient insomnia perception
timeFrame: until 24 weeks after enrolment
measure: Adherence to the intervention
timeFrame: until 24 weeks after enrolment
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
city: Montpellier
country: France
facility: Institut de Cancérologie de Montpellier
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Diane BOINON, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06086262: Hand Grip Strength in Athletic and Non-Athletic Girls at Different Phases of Menstrual Cycle
Official title: Hand Grip Strength in Athletic and Non-Athletic Girls at Different Phases of Menstrual Cycle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Grip
Athlete
Non-athlete
Menstrual Cycle
Keywords: Menstrual cycle
Female sex hormones
Athletic female
Power
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Forty healthy post-pubertal virginal females participated in this study. They were divided into two groups' athletic group of twenty basketball and tennis players and non-athletic group of twenty students. The non-athletic girls were recruited from undergraduate students of Faculty of Physical Therapy, Misr University for science and technology, while the athletic girls were recruited from basketball and tennis teams from Mena Garden City Club, 6 October Club and Shooting Club October.

Brief summary: The study was designed as an observational study

Detailed description: The study was designed as an observational case-control study

Eligibility criteria: Inclusion Criteria:

- 1. The participant had regular menstrual cycles, which were confirmed by using a calendar for three consecutive menstrual cycles, 2. The participant ages ranged from 16 to 22 years old, 3. The body mass index (BMI) ranged from 18.5 to 25 kg/m2. 4. For athletic group, they had participated in basketball and tennis teams for 3 to 4 years.

5. For non-athletic group, they had a sedentary life without any sport activities.

Exclusion Criteria:

* Participants were excluded from the study if they had:

  1. Irregular menstrual cycle
  2. Pelvic inflammatory diseases, pelvic infection or gynecological diseases.
  3. Any musculoskeletal disorders of Upper extremity or surgery, cardiovascular, pulmonary, neurological or systemic conditions.
  4. Receiving contraceptives or any hormonal therapy.

Primary outcomes:
measure: Menstrual cycle phases effect on grips power in athletic girls and non-athletic girls.
timeFrame: From November 2021 to April 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Aml M Yousef, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Hamada M Yousef
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Elham S Hassan, Teacher
role: STUDY_DIRECTOR
affiliation: Misr for science and techniology
name: Heba A Mohamed
role: STUDY_CHAIR
References:
Clinical trial NCT03929562: Alcohol Screening and Pre-Operative Intervention Research Study
Official title: Alcohol Screening and Pre-Operative Intervention Research Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Keywords: Elective Surgery
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-04-29
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to learn more about how to improve patients' health before and after a scheduled surgery by examining acceptability and initial efficacy of pre-operative alcohol use reduction interventions.

Detailed description: The study is a randomized clinical pilot trial that assesses preliminary intervention efficacy of a two-session health coaching intervention relative to brief advice among pre-operative elective surgical patients and evaluates intervention acceptability. Study subjects will be outpatients at a large health system in the midwestern United States and fulfill the study's inclusion criteria. Subjects will be randomized to one of two intervention conditions: Health Coaching or Brief Advice.

Eligibility criteria: Inclusion Criteria:

* Referred for elective or semi-elective surgery or pre-operative assessment in the next 120 days
* Meet criteria for "risky drinking" as defined by study staff

Exclusion Criteria:

* Displays or shows evidence of psychotic symptoms
* Undergoing surgeries that commonly require local anesthesia only

Primary outcomes:
measure: Mean Alcohol Weekly Use
timeFrame: Baseline through 4 months
Secondary outcomes:
measure: Acceptability of Intervention as Measured by the Post-intervention Evaluation.
timeFrame: Weeks 1-6, Immediately following intervention
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Anne Fernandez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00229762: Racial Disparities in Pneumococcal Vaccination in Managed Care
Official title: Racial Disparities in Pneumococcal Vaccination in Managed Care: the Effects of Randomized Telephone Outreach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumococcal Disease Prevention
Keywords: pneumococcal vaccination coverage with no disease or efficacy outcomes recorded
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Kaiser Permanente
First posted: 2005-09-30
Enrollment: 7000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

Brief summary: The goal of the study was to determine effectiveness of a telephone reminder to increase pneumococcal vaccination in a managed care population.

Detailed description: Patients randomized to the intervention arm received a telephone call from managed care nurses asking about their pneumococcal vaccination status and whether they would like to be vaccinated. We compared six month follow-up of pneumococcal vaccination in electronic medical records for the intervention versus control group. We tested the percent vaccinated in each randomization arm using chi-square tests for proportions.

Eligibility criteria: Inclusion Criteria:

- recommended for pneumococcal vaccination according to age or medical comorbidity

Exclusion Criteria:

- already known to have received pneumococcal vaccine

Primary outcomes:
measure: pneumococcal vaccination coverage
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Kaiser Permanente
state: Georgia
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Carla A Winston, PhD
role: PRINCIPAL_INVESTIGATOR
References: