louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05021315: Vaginal Cleaning Using Povidone Iodine Before CS to Reduce Postoperative Wound Infection
Official title: Effect of Vaginal Cleaning Using Povidone Iodine Before CS to Reduce Postoperative Wound Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cesarean Section Complications
Vaginal Infection
Postoperative Infection
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of work to assess the effectiveness of preoperative vaginal cleansing with povidone iodine on reduction of post caesarean section wound infection

Research questions:

Does vaginal cleaning using povidone iodine before cesarean section has effect on reduction of postoperative wound infection??


Eligibility criteria: Inclusion Criteria:

* 1. Pregnant women who are 37 weeks gestation or more scheduled for elective cesarean section or those in labor with a limited number of vaginal examinations less than 5 times preoperatively.

  2. Pregnant women who are 37 weeks gestation or more with rupture of membranes but duration less than 24 hours

  3. Women consenting to be included in the study.

Exclusion criteria:

1. Abnormally invasive placenta and placenta previa.
2. Intra-partum fever.
3. Prolonged rupture of membranes more than 24 hours
4. History of exposure to radiation treatment for cancer.
5. History of Gynecological infections (PID).
6. History of abdominal infections, e.g., peritonitis.
7. Debilitating diseases like Diabetes mellitus, Thyroid disorders, Cushing disease, abdominal malignancy.
8. Obesity is defined as pregnant BMI \>30 kg/m2.
9. History of wound infection or burst abdomen.
10. History suggestive of massive bleeding during previous cesarean section.
11. allergy to iodine-containing solutions
12. Pregnant women with severe anemia defined as Hb \<7 g/dl.
13. Cases with intra-abdominal drain deployment are discarded.
14. Obstructed labor with numerous vaginal examinations.

Primary outcomes:
measure: Postoperative wound complication
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of medicine - Cairo university
state: Kasr El Ainy
city: Cairo
country: Egypt
facility: faculty of medicine, Kasr el ainy hospital, Cairo university
Study officials:
affiliation: Ethical and scientific committee
name: Mostafa A Sleem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03146715: The Effect of a Nutrient Dense Food on the Skin CarotenoidLevels of School Age Children
Official title: The Effect of a Nutrient Dense Food on the Skin Carotenoid Levels of School Age Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Raman Spectroscopy
Children, Only
Lead sponsor: Utah State University
Sponsor class: OTHER
Collaborators: name: Utah Agriculture Experiment Station
First posted: 2017-05-10
Enrollment: 48
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Background: In a previous study, children who consumed a high-carotenoid juice over 8 weeks significantly increased skin carotenoid levels as compared to children who consumed a placebo juice. A naturally carotenoid-rich baked product, potentially marketable as a healthy breakfast food alternative, was developed by Utah State University researchers.

Objective: To determine the effect and response of a carotenoid-rich baked product on change in skin carotenoid levels among children.

Design: A six week randomized controlled trial. Participants/setting: Participants were children age 5-18 during March-June, 2015 living in Cache County, UT (n=46). Intervention: Children were randomly assigned to one of two groups: treatment (n=23) with a high carotenoid baked food or control (n=25) who consumed a baked food with no carotenoids. Children were asked to eat the designated portion of the assigned food once a day for six weeks. Skin carotenoid levels were measured every two weeks by a BioPhotonic scanner and reported in Raman intensity counts. Participants were asked to maintain their diet and completed a food frequency questionnaire at Baseline, Week 3, and Week 6. Uneaten portions of the food were returned to clinic, counted, and recorded.

Main outcome measures: Change in skin carotenoid levels as measured in Raman counts over 6 weeks.

Statistical analysis performed: Repeated-measures ANOVA was used to assess the group differences in Raman counts.


Eligibility criteria: Inclusion Criteria:

* Skin carotenoid levels 11,000-33,000 Raman intensity counts
* Age 5-18 years
* Willing to attend 7 clinic visits
* Willing to eat designated food each day for 6 weeks

Exclusion Criteria:

* Illness in two weeks before study began
* Chronic disease such as asthma, rheumatoid arthritis, type 1 diabetes
* Skin carotenoid levels \<11,000 and \>33,000 Raman intensity counts
* Consumption of high carotenoid supplements
* Use of topical self-tanning lotion

Primary outcomes:
measure: Raman resonance spectroscopy
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Logan
country: United States
facility: Utah State University, Center for Human Nutrition Studies
state: Utah
Study officials:
affiliation: Utah State University
name: Karin Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03674515: Study of Program Interest "Bouge" to Improve the Daily Physical Activity in Processings Treatment of Non-metastatic Breast Cancer
Official title: Study of Program Interest "Bouge" to Improve the Daily Physical Activity and Tolerance in Processings Treatment of Non-metastatic Breast Cancer at the Beginning Weekly Taxol Adjuvant Chemotherapy (Www.Bouge-coaching.Com)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Activity
Breast Cancer
Mobile Health Apps
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 214
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Evaluate the "Bouge" digital program (smartphone application) to increase the daily physical activity of breast cancer patients

Detailed description: Controlled, randomized, open, prospective, multicentric study, 214 volunteer patients aged between 18 and 70, with breast cancer, at the start of TAXOL treatment, possessing a smartphone, will be recruited and randomized into two groups:

107 in the control group (smartphone application "placebo" = number of steps) 107 will be equipped with the application "Bouge" = coached group

For three months, the patients do their daily physical activity. The "coached" group, through the smartphone application "Bouge", receives computer coaching to increase their physical activity (no direct medical intervention, only notifications and computer pusch).

The control group is not coached by the application (simple display of the number of step)

Eligibility criteria: Inclusion Criteria:

non-metastatic breast cancer start of treatment with TAXOL compatible smartphone

Exclusion Criteria:

age metastatic breast cancer

Primary outcomes:
measure: Increased daily physical activity (number of steps) using the smartphone application "BOUGE"
timeFrame: 12 weeks
Secondary outcomes:
measure: Well-being,
timeFrame: 12 weeks
measure: Well-being,
timeFrame: 12 weeks
measure: Fatigue
timeFrame: 12 weeks
measure: Sleep
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
city: Morlaix
country: France
facility: CHU de Morlaix
Study officials:
References:
Clinical trial NCT06232915: Accuracy of the Set Tidal Volume During Intraoperative Mechanical Ventilation
Official title: Accuracy of the Set Tidal Volume During Intraoperative Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Surgery
Mechanical Ventilation Pressure High
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children requiring intraoperative mechanical ventilation.

Brief summary: Prior to surgery the anesthesia team will be putting a breathing tube into the patient's windpipe and attaching it to a mechanical ventilator (breathing machine). This is to provide oxygen and anesthetic gas, and to help the child breathe while they're asleep. The ventilator also controls the amount of air that moves in and out of the lungs with each breath. This is called tidal volume and that amount is programmed into the machine by the anesthesia team. All of this is standard of care.

As part of the study the investigators will put a small flow sensor between the patient's breathing tube and the tubing from the ventilator. This will measure the amount of air that is moving in and out of the breathing tube. The study team will record the tidal volume that is set on the ventilator and compare it to the airflow measured by the ventilator and the airflow measured by the sensor and see if there is a difference.


Eligibility criteria: Inclusion Criteria:

* children aged 0-18 years having surgery at Nationwide Children's Hospital, in whom a cuffed ETT and mechanical ventilation will be used

Exclusion Criteria:

* children with preexisting airway anomalies or respiratory compromise will be excluded from the study.

Primary outcomes:
measure: Mean inspired tidal volume
timeFrame: Baseline
measure: Mean expired tidal volume
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT00411515: A Prospective Randomized Trial on Mycophenolate Mofetil in Risk Penetrating Keratoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Corneal Transplantation
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2006-12-14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this prospectively randomized multicentre study was to prove the efficacy and safety of mycophenolate mofetil (MMF) to preventing graft rejection and improvement of clear graft survival following high-risk keratoplasty.

The patients of the MMF group receive MMF orally 2x1 g daily for 6 months. Endpoints were immune reaction free and clear graft survival and the occurence of side-effects.


Eligibility criteria: Inclusion Criteria:

* Keratoplasty with increased risk for immunologic graft rejection in the abscence of other risk factors for graft failure. (repeat keratoplasty, steroid-response, limbo-keratoplasty, oversized graft.

Exclusion Criteria:

* Normal risk cases. Herpes-Keratitis. Glaucoma. Limbus stem cell deficiency.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: University Eye hospital
Study officials:
affiliation: University Eye Hospital, Freiburg
name: Thomas Reinhard, Prof. MD
role: STUDY_CHAIR
References:
citation: Reinhard T, Mayweg S, Sokolovska Y, Seitz B, Mittelviefhaus H, Engelmann K, Voiculescu A, Godehardt E, Sundmacher R. Systemic mycophenolate mofetil avoids immune reactions in penetrating high-risk keratoplasty: preliminary results of an ongoing prospectively randomized multicentre study. Transpl Int. 2005 Jun;18(6):703-8. doi: 10.1111/j.1432-2277.2005.00126.x.
citation: Birnbaum F, Mayweg S, Reis A, Bohringer D, Seitz B, Engelmann K, Messmer EM, Reinhard T. Mycophenolate mofetil (MMF) following penetrating high-risk keratoplasty: long-term results of a prospective, randomised, multicentre study. Eye (Lond). 2009 Nov;23(11):2063-70. doi: 10.1038/eye.2008.402. Epub 2009 Jan 16.
Clinical trial NCT04727515: General Anesthesia, Versus Axillary Block for Ambulatory Hand Surgery: Randomized Prospective Study
Official title: General Anesthesia, Versus Axillary Block for Ambulatory Hand Surgery: Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia, Local
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to compare between general anesthesia and axillary nerve block for ambulatory hand surgery regarding postoperative sleep pattern and efficacy.


Eligibility criteria: Inclusion Criteria:

* Physical Status: ASA I and II Patients after taking written and informed consent
* Body mass index less than 30

Exclusion Criteria:

* Refusal of procedure or participation in the study by patients.
* Physical status: ASA III or above
* Subjects presenting with allergy to local anesthetics, alcohol or drug abuse.
* Inability to cooperate mentally retarded patients.
* Bleeding disorders.
* Patients with preoperative obstructive sleep apnea (OSA) or any sleep disturbance.
* Patients with body mass index more than 30.
* Polytrauma patients or emergency operation

Primary outcomes:
measure: Incidence of Postoperative nausea and vomiting
timeFrame: First 24 hours postoperatively
Secondary outcomes:
measure: Visual analogue scale [VAS]
timeFrame: First 24 hours postoperatively
measure: Pittsburgh Sleep Quality Index
timeFrame: First 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
Study officials:
References:
Clinical trial NCT00276315: Assessment of Effectiveness and Safety of Dysport® for the Treatment of Hemifacial Spasm
Official title: A Phase III, Multicentre, Randomised, Assessor-blind, Parallel Groups, Reference Drug Controlled Study to Assess the Efficacy and Safety of a Single Administration, by Subcutaneous Injection of Dysport® for the Treatment of Hemifacial Spasm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemifacial Spasm
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2006-01-13
Enrollment: 332
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: To compare the effectiveness and safety of Dysport® with the domestic Botulinum Toxin Type A (manufactured by Lanzhou Biologic Product Institute, P.R. China) for the treatment of hemifacial spasm.


Eligibility criteria: Inclusion Criteria:

* Patient suffering from hemifacial spasm with at least 6 months duration (prior to visit 1)
* Cohen scale ≥ to grade II

Exclusion Criteria:

* Botulinum toxin type A treatment history within last 16 weeks prior to visit 1
* Hemifacial spasm secondary to facial palsy
* Previous alcohol or phenol injections or surgical therapy of the facial muscles
* Requirement for botulinum toxin injection to site(s) of the body other than in this study

Primary outcomes:
measure: Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels)
timeFrame: At the end of week 4
Secondary outcomes:
measure: Percentage of responders (defined as Cohen scale improvement ≥ to 2 levels after medication)
timeFrame: At the end of week 1 and 12
measure: Improvement degree of spasm (Jankovic scale)
timeFrame: At the end of week 1, 4 and 12
measure: Assessment of efficacy by the subjects
timeFrame: At the end of week 1, 4 and 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Neurology Department, Peking Union Medical College Hospital
city: Guangdong
country: China
facility: Neurology Department, Guangdong Provincial People's Hospital
city: Hangzhou
country: China
facility: Neurology Department, Sir Run Run Shaw Hospital, Zhejiang University
city: Shanghai
country: China
facility: Neurology Department, Shanghai Ruijin Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00337415: MK0354 Clinical Efficacy and Tolerability Study (0354-004)
Official title: Proprietary Information - Exploratory (Non-Confirmatory) Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Dyslipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-06-16
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: TREATMENT

Brief summary: A Research Study to Evaluate the Effectiveness and Tolerability of MK0354 vs Placebo (an inactive look alike pill) in Lipid (fat) Altering in Patients with dyslipidemia (a disorder of lipids in the blood)

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).


Eligibility criteria: Inclusion Criteria:

* Patient is between 18 and 75 years of age
* You have taken a statin or other lipid modifying therapy in the last 6-8 weeks
* You have lipid lab values outside of the range specified in the protocol

Exclusion Criteria:

* Patient is a woman who is pregnant or nursing a child
* Patient is a woman who is taking hormonal birth-control
* You are a woman who is planning to donate eggs during the study
* You plan to give blood during the study or have given within the last 8 weeks
* You are a woman who is having menopausal hot flashes or are taking medications to prevent menopausal hot flashes
* You have a known intolerance to or you are allergic to niacin
* You have any of the following medical conditions:
* Poorly controlled or newly diagnosed diabetes (within the last 3 months)
* Thyroid disease (hypothyroidism or hyperthyroidism)
* A history of stroke, heart attack, coronary bypass surgery, angioplasty, unstable angina or similar heart and artery procedures in the past 3 months
* History of hemorrhagic stroke or other non-traumatic hemorrhage
* Peptic ulcer disease in the last 3 months
* An occurrence of gout within the last year and you are not currently taking allopurinol
* Cancer (except for successfully treated skin cancer)
* HIV positive
* You have a history of drug/alcohol abuse within the last year
* You consume more than 2 drinks of alcohol per day
* You do not have access to a telephone
* You take medications that are not allowed in this study. The study doctor or staff will discuss this with you.
* Patient has participated in a study with an investigational drug within the last 30 days

Primary outcomes:
measure: proprietary information - exploratory (non-confirmatory) trial
Secondary outcomes:
measure: proprietary information - exploratory (non-confirmatory) trial
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05105815: Safety and Efficacy of Autoimmune Cell Therapy for Patients With Hepatocellular Carcinoma
Official title: An Exploratory Study on the Safety and Effectiveness of Autoimmune Cell Therapy Sensitized With Liver Cancer Neoantigen in Patients With High Risk of Recurrence After Surgical Resection of Primary Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Hepatocellular Carcinoma
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Immupeutics Medicine Technology Limited
name: Peking University People's Hospital
First posted: 2021-11-03
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, safety and effects of IPM001 vaccine on human hepatocellular carcinoma are going to be investigated, IPM001 is a neoantigen/tumor-specific antigen sensitized autoimmune cell injection


Eligibility criteria: Inclusion Criteria:

* understand and voluntarily sign a written informed consent;
* Age: from 18 to 75 years, No restriction on gender;
* Patients must have primary hepatocellular carcinoma;
* Clinical stage: stage Ia\~III a;
* Child-pugh score ≤7;
* HLA-A02 and consistent with ≥1 NeoAg or ≥2 aeTSA peptide bank;
* ECOG PS score: 0\~2;
* Laboratory values as follow:
* White blood cell count ≥ 3×109/L; Neutrophils: more than 1.5 × 109/L; Hemoglobin: more than 85g/L; Platelets: more than 5 × 1010/L; Total bilirubin:≤2 × ULN; Serum AST(GOT) and ALT(GPT)≤2.5 × ULN; Albumin ≥3.0 g/dL (30 g/L); Serum creatinine: less than 1.5 × ULN; Coagulation time was basically normal, PT extension ≤4s; No serious cardiopulmonary disease;
* Blood collection body weight: male \> 50 kg, female \> 45 kg;
* No obvious hereditary diseases;
* Expected survival: more than 6 months;

Exclusion Criteria:

* Patient has known distant organ metastasis;
* Suffer from lymphoma or leukemia or MDS (myelodysplastic syndrome), etc.;
* Woman be pregnant or lactating;
* Suffer from mental or neurological diseases that are resistant to control;
* The investigator judges that it is not suitable to participate in this clinical research (such as poor compliance, etc.);
* Patients infected with human immunodeficiency virus (commonly known as AIDS) or Treponema pallidum (commonly known as syphilis);
* Patients with a history of other malignant tumors in the past 5 years;
* Organ transplantation or Myelosuppression;
* History of drug abuse or alcohol abuse;

Primary outcomes:
measure: DFS
timeFrame: 18 months
Secondary outcomes:
measure: OS
timeFrame: 24 months
measure: EORTC-QLQ30
timeFrame: 18 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan hospital Fudan university
state: Shanghai
Study officials:
References:
Clinical trial NCT01729715: Helping Young Children Sleep
Official title: Helping Young Children Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Pediatric
Insomnia
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2012-11-20
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are conducting a randomized trial of behavioral treatments for young children with insomnia. The investigators are comparing the improvement in sleep patterns after families are given access to Internet sleep instructions compared to DVD sleep instructions.


Eligibility criteria: Inclusion Criteria:

* 6-36 months
* difficulties falling asleep or staying asleep
* DVD and internet access

Exclusion Criteria:

* Under 14 pounds
* Requires nighttime feeding or parental intervention for health reasons
* Chronic medical or psychological conditions such as asthma or autism
* Parents prefer co-sleeping

Primary outcomes:
measure: Brief infant sleep questionnaire
timeFrame: 3 weeks
Secondary outcomes:
measure: Profile of mood states
timeFrame: 1 week
measure: Pittsburgh sleep quality index
timeFrame: 1 month
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Mark Splaingard, MD
role: PRINCIPAL_INVESTIGATOR
References: