louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00476632: Epidemiology Controls Using Healthy Participants
Official title: Epidemiology Controls Using Healthy Participants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: Epidemiology
Questionnaire
Controls
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2007-05-22
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals 18 years or older with no history of cancer.

Brief summary: The goal of this research study is to identify biologic and lifestyle factors that may increase a person's risk of developing certain types of cancer.

Detailed description: For this study, you will be asked to complete a personal interview. During the interview, you will be asked questions about your demographics (age, sex, etc.), certain environmental exposures, your medical history, family history, your diet, and your smoking and alcohol use histories. It should take around 50 minutes to complete the interview.

You will also have around 2 ½ tablespoons of blood drawn for special tests. These tests will look for any biologic factors associated with certain cancers. The interview and blood draw will be scheduled at the time and place of your convenience. You will not be informed of the results of any of the testing done with your samples.

There is a possibility that you might be contacted in the future about if researchers need clarification on any of information already collected. You are free to refuse any further participation if you wish.

This is an investigational study. Up to 1,500 participants will take part in this study.

Eligibility criteria: Inclusion Criteria:

1. Individuals ages 18 and over with no prior cancer
2. Willing and able to complete an administered questionnaire
3. Willing and able to donate 30 mL of blood

Exclusion Criteria:

1. Individuals with prior cancer
2. Individuals under the age of 18

Primary outcomes:
measure: To identify biologic and lifestyle factors that may increase a person's risk of developing certain types of cancer.
timeFrame: 6 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Carrie Daniel-MacDougall, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02664532: Miller Straight Blade vs Macintosh Blade
Official title: Miller Straight Blade With Paraglossal Technique Compared to the Macintosh Blade in Respect to Visualization of Larynx and Ease of Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult
Lead sponsor: Tata Main Hospital
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this prospective open labeled randomized study was to compare the "laryngoscopic glottis view" as well as "ease of intubation" between the two blades in routine intubations in non-difficult airways.

Detailed description: One hundred and fifty patients with predicted non difficult airway were randomly assigned into two groups. After induction of anaesthesia laryngoscopy was performed with respective blades and trachea intubated. Parameters monitored were: glottis view obtained during laryngoscopy (Cormack Lehane grade), ease of intubation, intubation attempts, total duration of laryngoscopy in seconds and encountered complications.

Eligibility criteria: Inclusion Criteria:

* All ASA I \& II grade patients undergoing elective surgery requiring general anesthesia with oral endotracheal intubation

Exclusion Criteria:

* Patients with anticipated difficult airway
* Cervical spine disorders
* Anesthesia requiring rapid sequence induction

Primary outcomes:
measure: Ease of Intubation or Degree of Difficulty With Intubation
timeFrame: 60 seconds
Secondary outcomes:
measure: Cormack Lehane Grading
timeFrame: 60 seconds
measure: Number of Intubation Attempts
timeFrame: 180 seconds
measure: Total Laryngoscopy Duration in Seconds
timeFrame: 180 seconds
Other outcomes:
Locations:
Study officials:
affiliation: Tata Main Hospital, Jamshedpur,India
name: Bhanu Pratap Swain, DNB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01430832: Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum
Official title: The Long-Term Developmental Outcomes of Extreme Prematurity: Correlations With Maternal Post-Traumatic Symptoms, Parental Stress and Post-Traumatic Growth, 5-15 Years Postpartum
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Preterm Infants
Post Traumatic Stress Disorder
Emotional Stress
Infant, Very Low Birth Weight
Keywords: PTSD
Preterm
Premature
VLBW
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-09-08
Enrollment: 95
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are children born at Sheba Medical center between the years 1995-2006.

Brief summary: The purpose of this study is to assess the emotional well being of mothers to preterm infants with ELBW 5-15 years after the birth. Post-traumatic symptoms and parental stress levels will be taken into consideration. In addition, the correlation between the infant's development and the mother's emotional state will be analyzed.

Detailed description: Medical records of the children will be used for information in four categories: prenatal, birth, development,and demographic information. Parents will be contacted and interviewed regarding the child's development. In addition, they will complete the following questionnaires: PPQ-II Perinatal PTSD Questionnaire- modified, PTGI -The Posttraumatic Growth Inventory,Parental Stress Index- Short Form- PSI-SF, and Life Events questionnaire.

Eligibility criteria: Inclusion Criteria:

* Preterm Infant
* Very low birth weight or extremely low birth weight

Exclusion Criteria:

* Missing information regarding birth week and weight

Primary outcomes:
measure: Not relevant
timeFrame: Not relevant
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Lidia Gabis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ariel University
name: Gabi Zerach, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheba Medical Center
name: Shefer Shahar, Ph.D
role: STUDY_DIRECTOR
affiliation: Sheba Medical Center
name: Adi Elsing, BA
role: STUDY_DIRECTOR
References:
Clinical trial NCT05702632: TheraTogs Versus Reciprocal Electrical Stimulation on Children With Diplegic Cerebral Palsy: a Randomized Controlled Trial
Official title: Comparison of Thera-togs Orthotics With Reciprocal Electrotherapy for Postural Stability in Spastic Diplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children with diplegic cerebral palsy exhibit postural restrictions as a result of both primary and secondary brain damage impairments. One of the main goals of cerebral palsy rehabilitation is to improve balance and stability. As a result, the purpose of this study is to compare the effects of TheraTogs and reciprocal electrical stimulation on postural stability in children with diplegic CP.


Eligibility criteria: Inclusion Criteria:

* Diplegic children of both sexes are between the ages of 8 and 12. The level of spasticity in the lower limbs ranged from grade 1 to grade +1 on the modified Ashworth scale (MAS). The levels of motor function were between levels I and II, according to the Gross Motor Function Classification System (GMFCS).

Exclusion Criteria:

* If they had no major medical issues, according to their medical report. Skin diseases and allergic reactions to the adhesive tape used in this study were excluded, as were any deformities that interfered with lower limb functions, children with pace- makers who were contraindicated by electrical stimula- tion, children with visual, auditory, or perceptual deficits, and children with seizures.

Primary outcomes:
measure: postural stability
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
state: Eldoky
Study officials:
References:
Clinical trial NCT03571932: Assessment of Family Planning and Immunization Service Integration in Liberia
Official title: Assessment of Family Planning and Immunization Service Integration in Liberia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Contraceptive Usage
Contraception Behavior
Infant, Newborn, Diseases
Lead sponsor: Jhpiego
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: John Snow, Inc.
First posted: 2018-06-28
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 Intervention health facilities and 18 pair matched comparison health facilities in Grand Bassa and Lofa counties.

Brief summary: This is a mixed methods process evaluation of a programmatic intervention to integrate family planning and immunization services at health facilities in Lofa and Grand Bassa counties in Liberia. MCSP used a longitudinal, pair-matched design to monitor the effect of integrating immunization and FP services on utilization of FP and routine immunization services. In Lofa and Grand Bassa counties, 36 facilities were pair-matched to intervention and comparison sites based on predetermined criteria. After approximately 9 months of implementation, MCSP conducted a qualitative study employing key informant interviews (KIIs) and focus group discussions (FGDs) at intervention and comparison sites, and with district-, county-, and national-level MOH supervisors and managers.


Eligibility criteria: Inclusion Criteria:

* 18 intervention facilities in Lofa and Grand Bassa counties
* 18 pair matched comparison facilities in Lofa and Grand Bassa counties

Exclusion Criteria:

* Facilities not included in the intervention or selected for pair matching

Primary outcomes:
measure: Number of modern family planning users
timeFrame: November 2016-July 2017
measure: Number of Penta 1 doses administered
timeFrame: November 2016-July 2017
measure: Number of Penta 3 doses administered
timeFrame: November 2016-July 2017
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04361032: Assessment of Efficacy and Safety of Tocilizumab Compared to DefeROxamine, Associated With Standards Treatments in COVID-19 (+) Patients Hospitalized In Intensive Care in Tunisia
Official title: Assessment of Efficacy and Safety of Tocilizumab Compared to DefeROxamine, Associated With Standards Treatments in COVID-19 (+) Patients Hospitalized In Intensive Care in Tunisia. Multicentric, Comparative, Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: COVID19
Intensive Care Unit
Keywords: Deferoxamine
Tocilizumab
Lead sponsor: Abderrahmane Mami Hospital
Sponsor class: OTHER
Collaborators: name: Eshmoun Clinical Research Center
name: Datametrix
First posted: 2020-04-24
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assessment of Efficacy and Safety of Tocilizumab Compared to DefeROxamine, associated with standards treatments in COVID-19 (+) patients, Hospitalized In Intensive care in Tunisia.

Multicentric, comparative, randomized study.

Detailed description: Arm1 :

* Usual standard treatment\*
* Tocilizumab (LOC) (8mg/ kg per day) (1 injection per infusion) a second injection may be considered if necessary, but no more than 800 mg per day. Only on the 1st day (D0)
* Enoxaparin (4000 IU X 2) per day for the duration of hospitalization

VERSUS

Arm 2:

* Usual standard treatment\*
* Deferoxamine (Desferal 500 mg, powder, and solvent for IV solution) by electric syringe 40 mg/kg/day 5day/7 without exceeding 5 g per day for 14 days
* Enoxaparin (4000 IU X 2) per day for the duration of hospitalization

Usual standard treatment\*: according to the standard practices of each center, apart from the active molecules of the 2 arms and their therapeutic class)

Eligibility criteria: Inclusion Criteria:

* Patient confirmed COVID19 positive
* Patient with acute respiratory deficiency
* Patient hospitalized in the intensive care unit
* Age \>18 years old
* Having given written consent for their participation in the study

Exclusion Criteria:

* Taking Tocilizumab or hydroxychloroquine deferoxamine within one month prior to inclusion (excluding participation in THINC or COVID_2Pro or COVID+PA studies)
* Severe/severe liver failure
* Dialysis patients
* Renal insufficiency (clearance\< 30ml/min/1.73m2)
* Allergy to deferoxamine
* Pregnant or breastfeeding woman
* Hypersensitivity to the active substance or any of the excipients of Tocilizumab
* A decrease in blood platelets with previous use of enoxaparin or another heparin drug,
* hemophilia and related diseases,
* stomach or duodenal ulcer

Primary outcomes:
measure: the mortality rate
timeFrame: 90 day
Secondary outcomes:
Other outcomes:
Locations:
city: Ariana
country: Tunisia
facility: Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana
Study officials:
References:
Clinical trial NCT06439732: Impact of Using an Hemodynamic Monitoring System on Anesthetic Consumption During Abdominal Surgery
Official title: Impact of Using an Hemodynamic Monitoring System on Anesthetic Consumption During Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypotension During Surgery
Keywords: Anestethic comsumption
hemodynamic monitoring
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study investigators will study the association between the use of an hemodynamic monitoring system and the anesthetic consumption in patients following major abdominal surgery. Investigators will randomise patients for a control group and an intervention group. Patients belonging to intervention group will be monitored with a non-invasively continue system (Acumen IQ cuff sensor), while the control group will be monitored with a non-invasive intermittent pressure system. The total amount of mL of Sevoflurane will be registered in both groups and the difference will be considered as the aim of our study


Eligibility criteria: Inclusion Criteria:

* over 18 years of age
* signature of informed medical consent

Exclusion Criteria:

* BMI\> 30
* eGFR\<30
* NYHA III-IV
* severe cardiac valvular diseases
* absence of informed medical consent

Primary outcomes:
measure: Reduction in Anesthetic consumption
timeFrame: During surgery
Secondary outcomes:
measure: number hypotensive episodes
timeFrame: during surgery
measure: duration hypotensive episodes
timeFrame: during surgery
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario "A. Gemelli" IRCCS
Study officials:
affiliation: Fondazione Policlinico universitario Agostino Gemelli
name: Andrea Russo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02256332: Plant-based Ingredient on Post Prandial Glucose in Type II Diabetes
Official title: Effect of Plant-based Ingredient on Post Prandial Glucose in Untreated Type II Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
First posted: 2014-10-03
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Effects of a plant based ingredient on blood glucose in Type II diabetes patients.

Detailed description: The study is designed to determine the extend to which a plant based ingredient in a food format affects blood glucose responses in untreated Type II diabetes patients.

Eligibility criteria: Inclusion Criteria:

* Male and female volunteers with confirmed Type II diabetes not treated with pharmaceutical-based glucose lowering treatment for past three months (controlled solely through diet and exercise);
* Age ≥ 20 and ≤ 65 year at screening;
* Body Mass Index (BMI) between ≥18 and ≤ 32 kg/m2;
* HbA1c ≥48 mmol/mol and ≤53 mmol/mol (≥ 6.5% and ≤ 7.0%). At discretion of the study physician, subjects with HbA1c \>53 mmol/mol and \<58 mmol/mol (\>7.0% and \< 7.5%) controlled solely through diet and exercise are also allowed to participate.

Exclusion Criteria:

* Being an employee of Unilever or research site;
* Chronic smokers, tobacco chewers and drinkers;
* No medication, including vitamins and tonics, except for cholesterol, as determined by the physician;
* Reported weight loss/gain ≥ 10% of body weight in the 6 months preceding screening;
* Allergy to any food or cosmetics;
* If female, not being pregnant or planning pregnancy during the study period;
* If female, lactating or has been lactating for 6 weeks before pre-study investigation and/or during the study period.

Primary outcomes:
measure: Post prandial blood glucose positive incremental area under the curve
timeFrame: 120 minutes
Secondary outcomes:
measure: Post prandial insulin area under the curve
timeFrame: 120 minutes
Other outcomes:
measure: Post prandial blood glucose positive incremental area under the curve
timeFrame: 180 and 240 minutes
measure: Post prandial insulin area under the curve
timeFrame: 180 and 240 minutes
measure: Glucose levels in urine
timeFrame: 240 minutes
measure: Intestinal discomfort
timeFrame: 240 minutes
Locations:
city: Thane
country: India
facility: Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA
state: Maharashtra
city: Ahemdabad
country: India
facility: Lambda Therapeutics Research Ttd (LTRL)
Study officials:
affiliation: Lambda Therapeutics Research Ltd (LTRL)
name: Dr Ketul Modi, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA
name: Dr Shrikant V Deshpande
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02595632: Breath Analysis in Healthy Controls
Official title: Exhaled Breath Analysis by Secondary Electrospray Ionization (SESI-MS) in Healthy Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exhaled Breath
Mass Spectrometry
Healthy Subjects
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss Federal Institute of Technology
First posted: 2015-11-03
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy subjects will be included according to the predefined inclusion and exclusion criteria. They will be recruited from the general population by printed flyers, newspaper advertisements and personal communication.

Brief summary: The purpose of this study is to detect a specific profile of breath in healthy subjects by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.


Eligibility criteria: Inclusion Criteria:

1. Normal spirometry (forced expiratory volume in 1 second (FEV1) \> 80%, forced vital capacity (FVC) \> 80%, FEV1/FVC \> 70%.).
2. Age between 18 and 90 years at study entry.

Exclusion Criteria:

1. Presence of an active malignancy.
2. Presence of any lung disease (e.g. asthma, chronic obstructive pulmonary disease (COPD), sarcoidosis)
3. Acute inflammatory disease (e.g. common cold) within the last 6 weeks.
4. Acute or chronic hepatic disease.
5. Renal failure or renal replacement therapy.

Primary outcomes:
measure: The primary outcome will be the mass spectrometric exhaled breath pattern of healthy subjects.
timeFrame: 1 day, single measurement, no follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Pulmonary Division
Study officials:
References:
Clinical trial NCT02079337: Validation of Subjective Rating Scales Used to Assess Surgical Conditions in Abdominal Surgery
Official title: Validation of Subjective Rating Scales Used to Assess Surgical Conditions in Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgical Conditions
Rating Scales
Laparoscopy
Neuromuscular Blockade
Pneumoperitoneum
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2014-03-05
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Use of neuromuscular blockade (NMB) may improve the surgical work space in patients scheduled for laparoscopic surgical cases (e.g. hysterectomy, ovarian cystectomy, myomectomy). Clinical studies investigating this question often use a numerical or verbal rating scale for subjective evaluation of the surgical workspace. However, no good subjective rating scale have been developed or validated. Neither have possible inter-individual differences in use of such subjective scales been described.

Purpose:

The aim of this study is to validate different subjective rating scales to determine which scale is most useful among surgeons.


Eligibility criteria: Inclusion Criteria:

* patients \> 18 years old
* elective gynecologic laparoscopic operation
* can read and understand Danish
* informed consent

Exclusion Criteria:

* BMI \> 30 kg/cm2
* known allergy to medications that are included in the project
* severe renal disease, defined by S-creatinine\> 0,200 mmol/L, GFR \< 30ml/min or hemodialysis)
* neuromuscular disease that may interfere with neuromuscular data
* lactating or pregnant
* impaired liver function
* converting to laparotomy
* perioperative use of neuromuscular blocking agents before randomization
* pneumoperitoneum set to \>12 mmHg on the insufflator

Primary outcomes:
measure: Subjective rating scale
timeFrame: Evaluation of video images within a time frame of in average 5 months after surgery
Secondary outcomes:
measure: Number of correct estimates of level of NMB
timeFrame: Evaluation of video images within a time frame of in average 5 months after surgery
measure: Number of correct estimates of level of NMB according to grade of surgical experience
timeFrame: Evaluation of video images within a time frame of in average 5 months after surgery
Other outcomes:
Locations:
city: Søborg
country: Denmark
facility: Department of minimal invasive gynecology Aleris-Hamlet Private Hospital
Study officials:
affiliation: Herlev Hospital Department of Anethesiology
name: Matias V Madsen, MD
role: PRINCIPAL_INVESTIGATOR
References: