louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01585792: Double Blind Comparative Study of TAK-875
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Patients
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-04-26
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of treatment with TAK-875 in diabetic patients.


Eligibility criteria: Inclusion Criteria:

* The participant is an outpatient.
* The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria:

* The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
* The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator.

Primary outcomes:
measure: Blood glucose
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Sumida-ku
country: Japan
state: Tokyo
Study officials:
References:
Clinical trial NCT03508492: Surgeons' Satisfaction With Two Types of Tinted Chlorhexidine Applicators (Chloraprep® and Nex Clorex 2%)
Official title: Comparative Study to Asses the Satisfaction With Tinted Chlorhexidine Applicators (Chloraprep® and Nex Clorex 2%)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Satisfaction
Product Quality
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The development of surgical site infections (SSI) in clean-contaminated surgery is regarded as being preventable. Known to be effective in the prevention of surgical site infection are the adequate sterilization of the surgical instruments, asepsis during operation, antibiotic prophylaxis where indicated, and certainly the preparation of the skin at the incision site. During the last decades the use of alcoholic chlorhexidine has replaced povidone iodine for preoperative skin preparation. In order to improve the way alcoholic chlorhexidine is applied, pharmaceutical industry has developed new applicators.

This randomized study was conducted to know the surgeons' satisfaction within the use of two tinted applicators: Chloraprep® and Nex Clorex 2%


Eligibility criteria: Inclusion Criteria:

* Volunteer surgeons from colon, cardiac, knee and hip surgical departments. Once surgeon has enrolled the study, patients will be selected if they have hospital admission with scheduled surgery and have signed informed consent

Exclusion Criteria:

* Urgent surgeries
* Outpatient surgery
* Surgical complex cures
* Mixed interventions: exploratory or sequential
* Unscheduled surgeries
* Rejection of participation
* Chlorhexidine or isopropyl alcohol hypersensibility patients
* If any patients changed its mind after signing the informed consent will be removed from the study.

Primary outcomes:
measure: Surgeon's global satisfaction with the applicators.
timeFrame: Intraoperative
measure: Qualities of each applicators
timeFrame: Intraoperative
Secondary outcomes:
measure: Costs of using the applicators
timeFrame: Through study completion, an average of 3 months
measure: Adhesion to preoperative measures to avoid surgical site infections (SSI)
timeFrame: Through study completion, an average of 3 months
measure: Surgical site infection incidence
timeFrame: During the first 30 to 90 days after surgery, according to the SSI prevention protocol
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04586192: Digital Mental Health and Wellness Intervention for Adults: A Randomized Control Trial of COMET
Official title: Developing and Assessing a Digital Mental Health and Wellness Intervention for Adults: Randomized Control Trial of the Common Elements Toolbox (COMET)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Symptoms
Anxiety
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators are evaluating the acceptability and effectiveness of brief online wellness modules. Participants will be randomly assigned to the intervention condition, an active control condition, or a wait-list control condition. The investigators are using a factorial design, such that each participant in the intervention condition will be randomly assigned to receive three of four wellness modules.

The investigators will analyze the intervention's effectiveness as a universal intervention (using the full sample) and a targeted intervention (using the subset of the sample that reported elevated depressive symptoms or anxiety symptoms at baseline).


Eligibility criteria: Adult participants (at least 18 years old) will be eligible for this study.

Primary outcomes:
measure: Change in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Up to 12 weeks post-intervention
measure: Change in Generalized Anxiety Disorder Screener-7 (GAD-7)
timeFrame: Up to 12 weeks post-intervention
measure: Change in Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
timeFrame: Up to 12 weeks post-intervention
measure: Ratings of Acceptability of Intervention Measure (AIM)
timeFrame: Immediately after the intervention
measure: Mechanism Questions
timeFrame: Up to 12 weeks post-intervention
measure: Ability to Cope with COVID-19
timeFrame: Up to 12 weeks post-intervention
measure: Secondary Control
timeFrame: Up to 12 weeks post-intervention
measure: Perceived Utility
timeFrame: Immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Robert J DeRubeis, PhD
role: STUDY_DIRECTOR
affiliation: University of Pennsylvania
name: Akash Wasil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02352792: Hypoxia-based Dose Escalation With Radiochemotherapy in Head and Neck Cancer
Official title: Randomized Phase II Study for Dose Escalation in Locally Advanced Head and Neck Squamous Cell Carcinomas Treated With Radiochemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords: Local control
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 90
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: Patients with locally advanced suqamous cell carcinoma of the head and neck region receive a hypoxia scan either by magnetic resonance tomography, computed tomography or fluoromisonidazole (FMISO)-PET-CT. Patients presenting with hypoxia are randomized into standard therapy consisting of intensity modulated radiotherapy (IMRT) with 70 Gy plus either 5-fluorouracil/mitomycin C or cisplatinum (Arm A) or a dose escalation of 10% (77Gy) to the hypoxic volume applied via simultaneous integrated boost in addition to the standard treatment (Arm B).


Eligibility criteria: Inclusion Criteria:

* histologically verified squamous cell carcinoma of the head and neck region stage III and IV eligible for primary radiochemotherapy
* measurabel disease by CT and/or MRT and/or FDG-PET-CT
* fit for chemotherapy
* no prior radiotherapy or major surgery in the head/neck region
* Karnofsky Index \> 60%
* informed consent

Exclusion Criteria:

* uncontrolled secondary cancer
* distant metastases
* pregnancy
* expected malcompliance

Primary outcomes:
measure: time to local recurrence
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Tuebingen university, radiation oncology
state: Baden-Württemberg
Study officials:
affiliation: radiation oncology
name: Stefan Welz, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02578992: "Neutral Head Position" and "Head-lift Position" for Orotracheal Intubation With "Trachway" Intubating Stylet in Adults
Official title: "Neutral Head Position" and "Head-lift Position" for Orotrachwal Intubation With "Trachway" Intubating Stylet in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult
Keywords: intubating stylet
head and neck position
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 130
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate two different patient's head and neck positions(neutral head position and head-lift position) for the effectiveness of orotracheal intubation with using the "Clarus Video System (Trachway®)" intubating stylet.

Detailed description: The sniffing position has traditionally been considered the optimal head position for direct laryngoscopy, However, it may aggravate cervical spine injury. The Trachway® video stylet is an intubating device that may avoid cervical movement during intubation. Nonetheless, the effectiveness of limited neck movement in patients with neutral head or head-lift position using the Trachway® video stylet remains unclear. The purpose of this study was to compare the intubation time of the two positions with the Trachway® video stylet.

Eligibility criteria: Inclusion Criteria:

* patients scheduled for various surgeries requiring general anesthesia with tracheal intubation
* American Society of Anesthesiologists(ASA) physical status classification I-III

Exclusion Criteria:

* pneumothorax
* room air saturation by pulse oximeter saturation less than 96%
* vocal cord palsy
* craniofacial anomaly
* congenital upper airway anomaly
* upper airway disease
* cervical spine pathology
* head and neck tumor status post radiotherapy
* an increased risk of regurgitation or pulmonary aspiration
* a history of difficult tracheal intubation

Primary outcomes:
measure: Intubation Time
timeFrame: from the intubating stylet touched the mouth to the capnogram shown, up to 30 seconds, and the sum of all attempts
Secondary outcomes:
measure: Modified Cormack-Lehane Grade
timeFrame: during intubation, after epiglottis was identified on the video monitor
measure: Mean Arterial Pressure
timeFrame: before and after intubation, up to 5 minutes
measure: Visual Analog Scale of Sore Throat
timeFrame: after anesthesia emergence 30 minutest, at post-anesthesia care unit
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
References:
Clinical trial NCT02166892: Specially Designed Eating Plates Effects on Food Intake in Normal Weight and Overweight Children
Official title: The Effect of Specially Designed Eating Plates on Self-served Portions and Caloric Intake in Normal Weight and Overweight Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Childhood obesity
Plate
Food consumption
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2014-06-18
Enrollment: 22
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Previous studies demonstrated that children served themselves more food when using larger plates and bowels. The purpose of this study is to evaluate if self-served portions and caloric intake in normal weight and overweight children will be influenced by a specially designed eating plates compared to similar size normal plates.

Detailed description: 40 normal weight and 40 overweight kindergarden and elementary school children will participate in this study.

Anthropometric measurements: weight, height, BMI and BMI percentiles will be measured and calculated for each participant.

The participants will take part in two non-exercise activities at the 'sport and health center for children and adolescence'. At the end of each activity, a lunch buffet that contains all food ingredients will be served. During one meeting the children will be handed a regular plate and at the second meeting they will be handed a specially designed plate (with marking of the recommended meal composition and portion).

The amount and composition of food on the plates will be assessed by weighing and photography before and after eating and analysed to report macronutrient consumption by a dietitian. The meetings for normal weight children will be separated from the overweight children.

Eligibility criteria: Inclusion Criteria:

* Over weight / obese children
* Normal weight children

Exclusion Criteria:

* Organic disease that cause obesity
* Underweight children (BMI percentiles \< 5)

Primary outcomes:
measure: Caloric intake
timeFrame: Up to 1 hour after food serving
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Dan Nemet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06419192: Modifying Nutrition to Modify Delivery in Nulliparous Women
Official title: Evaluation of the Feasibility and Acceptability of Dietary Advice to Encourage Spontaneous Work: Randomised Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pregnant Woman
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In France, around 20% of women exceed the term of 41 weeks' amenorrhoea (SA). Maternal and foetal morbidity and mortality are increased when the term is exceeded, which justifies inducing labour. However, induction also increases maternal and foetal morbidity.

According to several studies, regular consumption of dates during the last month of pregnancy may increase the rate of spontaneous labour and natural childbirth.

Single-centre, randomised, open-label, 3-arm study :

Experimental group n°1: 'dietary advice + food provided'. Advice to eat 7 dates a day from 37 weeks' gestation until delivery. The quantity of dates required will be provided to the women.

Experimental group 2: 'dietary advice alone'. Advice to eat 7 dates a day from 37 weeks' gestation until delivery. The food will not be provided.

Control group: no specific dietary advice. Routine care group.


Eligibility criteria: Inclusion Criteria:

* Pregnant women
* Age ≥ 18 years
* Nulliparous
* Single pregnancy with fetus in cephalic presentation
* Pregnancy with physiological course
* Gestational age ≥ 34 and ⩽ 37 SA
* Membership of a social security scheme (CMU accepted)
* Signed informed consent

Exclusion Criteria:

* Any contraindication to vaginal delivery
* Presence of a foetal malformation
* Diabetes of any type (1, 2 or gestational)
* Food allergy contraindicating participation in the study
* Illiterate or non-French-speaking women
* Women under guardianship or trusteeship

Primary outcomes:
measure: Rate of compliance with dietary advice to eat 7 dates a day at the end of pregnancy in nulliparous women.
timeFrame: From 37 weeks'amenorrhoea to delivery (up to 41 weeks)
Secondary outcomes:
measure: Evaluation of women's experience of the intervention using a post-partum questionnaire
timeFrame: Following childbirth, during the stay in the maternity ward ; assessed up to 5 days
Other outcomes:
Locations:
city: Tours
country: France
facility: Gynaecology-obstetrics, University Hospital, Tours
Study officials:
affiliation: University Hospital, Orléans
name: Adeline DE WITT, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03280992: Community Acquired Sepsis Cohort
Official title: Community Acquired Sepsis Cohort
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Severe Septic Syndrome
Septic Shock
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 796
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with a community infectious diseases

Brief summary: The aim of this project is to constitute a prospective cohort of all the patients presenting to the adult emergencies of the University Hospital Centre (CHU) of Rennes for a septic syndrome of community origin.

Detailed description: Severe septic syndrome (SSG) and septic shock (CS) are two frequent and serious complications of infectious diseases. In this context, the optimization of the management of septic patients from their reception in the emergency services must be a priority. However there are no predictors of progression or severity in patients admitted to emergencies despite the recommendations emphasizing the need for screening and early therapeutic management. Many scores have been proposed for intensive care unit but they remain difficult to extrapolate to other services because they are very comprehensive and require information that is difficult to obtain for emergency physicians.

Eligibility criteria: Inclusion Criteria:

* Patient older than 18 years old
* Patient hospitalized during the study period for community infectious diseases at the CHU of Rennes

Exclusion Criteria:

* Written objection from the patient to the computer processing of his data
* Pregnant women
* Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty

Primary outcomes:
measure: Assessment of morbidity in patients with septic syndrome of community origin
timeFrame: Day 90
measure: Internal validity, severity score
timeFrame: Day 90
measure: Internal validity, triage score by orientation nurses
timeFrame: Day 90
measure: Study of the prognostic factors of patients with septic syndrome of community origin in terms of mortality
timeFrame: Day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References:
Clinical trial NCT00337792: Comparing the Effectiveness of Oral Versus Intravenous Pain Medicine for Suction Curettage (D&C)
Official title: A Randomized Clinical Trial Comparing Oral Conscious Sedation With Intravenous Conscious Sedation for First Trimester Surgical Abortion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Undesired Pregnancy
Lead sponsor: Planned Parenthood League of Massachusetts
Sponsor class: OTHER
First posted: 2006-06-16
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to determine the equivalency of oral conscious sedation and intravenous conscious sedation for first trimester surgical abortion. We hypothesize that oral conscious sedation will be equivalent to intravenous conscious sedation for pain control. Additional objectives include describing subject satisfaction with each method of pain control and characteristics of each method such as side effect profile, recovery room time, and postoperative pain.

Detailed description: The main objective of this study is to determine the equivalency of oral conscious sedation (oxycodone 10mg PO plus lorazepam 1mg SL) and intravenous conscious sedation (fentanyl 100 µg plus midazolam 2mg) for first trimester surgical abortion. We hypothesize that oral conscious sedation will be equivalent to intravenous conscious sedation as defined by ± 1 point on a 21-point pain scale. Subsidiary objectives include describing subject satisfaction with each method of pain control and characteristics of each method such as side effect profile, recovery room time, and postoperative pain.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older.
* Undesired pregnancy between 6 0/7-12 6/7 weeks gestation.
* Has already signed consent for pregnancy termination.
* Eligible for IV sedation per clinic protocol.

Exclusion Criteria:

* Under 120 lbs.
* Allergies to any of the drugs being studied.
* Chronic narcotics, barbiturates or benzodiazepine use within the past year.
* History of IV drug use within the last year.
* Inability to give informed consent.
* Does not speak English or Spanish and does not have translator for all study procedures
* Previously participated in study

Primary outcomes:
measure: Pain scale
Secondary outcomes:
measure: Measures of satisfaction, side effects, recovery time
Other outcomes:
Locations:
city: Boston
country: United States
facility: Planned Parenthood League of Massachusetts
state: Massachusetts
Study officials:
affiliation: Planned Parenthood League of Massachusetts
name: Jane Doe
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allen RH, Fitzmaurice G, Lifford KL, Lasic M, Goldberg AB. Oral compared with intravenous sedation for first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2009 Feb;113(2 Pt 1):276-83. doi: 10.1097/AOG.0b013e3181938758.