louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03473652: Feasibility of Adapted Physical Activity Based on a Walking Platform in Hospitalized Old Patients for Cancer
Official title: Feasibility of Adapted Physical Activity Based on a Walking Platform in Hospitalized Old Patients for Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oncology
Adapted Physical Activity
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 45
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The investigator propose to evaluate the interest of the provision of a suitable treadmill offering fall protection and verticalization assistance.


Eligibility criteria: Inclusion Criteria:

* Patient with cancer
* Patient over 70 years old hospitalized 48 hours or more
* Patient identified as eligible for medical prescription of Adapted physical activity
* Mastery of the French language ;
* Patient affiliated to a social security scheme
* Patient giving written consent

Exclusion Criteria:

* Patient totally unable to communicate
* Patient in terminal palliative care
* Patient with a size \<1m35 or\> 2m and / or a weight\> 130kg
* Patient unable to perform Adapted physical activity sessions
* Patient unable to wear a restraint harness.
* Patient deprived of liberty or under guardianship
* Patient unable to comply with protocol requirements for geographical, social or psychopathological reasons

Primary outcomes:
measure: Patient adherence to use a walking Platform
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
city: Caen
country: France
facility: CHU
Study officials:
References:
Clinical trial NCT03372252: Impact of the Inspiratory Cortical Control on the Outcome of the Ventilatory Weaning Test in Patients Intubated in Resuscitation
Official title: Impact of the Inspiratory Cortical Control on the Outcome of the Ventilatory Weaning Test in Patients Intubated in Resuscitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiration Disorder
Respiratory Failure
Weaning Failure
Respiratory Compensation
Respiratory Center Dysfunction
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In case of respiratory distress, patients are intubated to be connected to an artificial respirator to ensure gas exchanges. Before any ventilatory weaning, a breathing test in spontaneous ventilation under artificial nose is practiced. The patient keeps the endotracheal tube but is no longer assisted by the ventilator. Mortality is markedly increased with the prolongation of the weaning period. Despite the presence of all weaning criteria and the success of a breathing test in spontaneous ventilation under artificial nose, failure of extubation occurs in 20% of patients.

Experimental application of an additional inspiratory load in awake healthy subjects causes a compensatory increase in respiratory work to maintain effective ventilation, and the subject does not develop hypoventilation. This respiratory drive to breathe has been demonstrated by quantified electroencephalography in inspiratory load tests in the form of pre-inspiratory negative deflections of low amplitude similar to the potential described during the preparation of the voluntary movement of a limb. These inspiratory pre-motor potentials begin about 2.5 seconds before the start of a movement in the additional motor area.

Does the simple and noninvasive analysis of inspiratory cortical control during the spontaneous ventilation breath test under artificial nose predict the outcome of this test as well as weaning at 7 days?


Eligibility criteria: Inclusion Criteria:

* All intubated-ventilated patients eligible for an artificial nose breathing test in spontaneous ventilation, according to the physician in charge, and to the protocol of the medical resuscitation service and good clinical practice,
* at least 18 years of age;
* intubated-ventilated for at least 24 hours;
* express consent given by patients or "relatives" after clear and fair information on the study.

Exclusion Criteria:

* Patients are secondarily excluded from the study only if EEG or pressure monitoring are uninterpretable.

Primary outcomes:
measure: Magnitude of inspiratory premotor potentials
timeFrame: Fifteen minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: university hospital center of Poitiers
state: Vienne
Study officials:
References:
Clinical trial NCT03905252: Biomarkers for Human Heart Failure
Official title: Biomarkers for Human Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CHF
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 535
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eight Hundred HF patients hospitalized for symptomatic HF at Mayo Clinic Hospital - St Mary's Campus, Rochester, Minnesota

Brief summary: The purpose of this study is to establish the various ranges of proteins that can be assayed in the plasma and urine from hospitalized patients with all classes of heart failure and/or STEMI (ST-segment elevation myocardial infarction)/NSTEMI (Non-ST-segment elevation myocardial infarction), as well as history reviews.

Detailed description: Schematic Design of the Study: Single blood draw, one random urine and 24-hr urine collection from hospitalized patients with chronic/acute heart failure and/or STEMI-NSTEMI. If there should be a subsequent hospitalization,another collection of a 45 ml blood sample, random urine and one 24-hour urine collection may be completed if indicated at initial hospitalization.

Aims:

The purpose of this study is to attempt to establish the various ranges of proteins that can be assayed from the plasma and urine of patients with all classes of heart failure and MI (myocardial infarction). Follow-up hospitalizations may result in another 45 ml blood draw, random urine and 24-hr. urine collection to evaluate the outcome of the heart failure treatment used with the previous hospitalization, if indicated in consent. A history review will be necessary as well.

Eligibility criteria: Inclusion Criteria:

• Diagnosis of Acute decompensated heart failure

Exclusion Criteria:

• Hemoglobin less than 10, active cancer, or amyloidosis Patient with dialysis

Primary outcomes:
measure: uAGT levels in high-risk chronic HF patients
timeFrame: 10 years
measure: Natriuretic peptide levels in ADHF patients
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Foundation
state: Minnesota
Study officials:
affiliation: Mayo Foundation
name: John C Burnett, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03104452: Helping Moms Who Smoke
Official title: Enhancing the Delivery of Tobacco Treatment During Pregnancy and Postpartum Though Systems-Change
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking Cessation
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from obstetric and family practice clinics identified by the researchers.

Brief summary: The purpose of this study is to learn how women's smoking changes during their pregnancy and as a new mom, and to assess the help they receive from their health care providers.

Detailed description: Approximately 90% of women who smoked before pregnancy will be smokers within one year of delivery . This occurs even though half who smoke quit during the course of pregnancy. This is an observational, cohort study of pregnant women who smoked in the six months before becoming pregnant. Women will be followed from the first trimester to one year after the birth of their babies. The results of this study will help us to describe women's' views on the quality of tobacco counseling they receive from their doctors; understand patterns of smoking and quitting throughout pregnancy and after childbirth; and provide information needed to develop an intervention to help women quit.

Eligibility criteria: Inclusion Criteria:

* Smoked within six months prior to becoming pregnant or current smoking
* Smoked at least 100 cigarettes
* Pregnant
* English speaking
* Access to a cell phone
* Willing to receive and send text messages.

Exclusion Criteria:

* Quit for longer than 6 months before becoming pregnant

Primary outcomes:
measure: Smoking status
timeFrame: 1 year post-partum
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Taneisha Scheuermann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04020952: Effect of Archwire Gauge on the Rate of Canine Retraction
Official title: Effect of Archwire Gauge on the Rate of Canine Retraction in Adults: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Canine Retraction
Keywords: canine retraction
archwire gauge
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 18
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups of patients each receives different wire gauge during canine retraction phase during space closure.
Primary purpose: TREATMENT

Brief summary: trial will be done to evaluate the effect of archwire gauge on the rate of canine retraction, canine tip and torque, root resorption and loss of anchorage in maxillary dental protrusion cases requiring first premolars extraction.

Detailed description: Three working archwires of different gauges will be used during canine retraction; st.st 0.019×0.025" as a comparator, st.st 0.016×0.022" and st.st 0.017×0.025" wires as interventions. after levelling and alignment till reaching the working archwire, it will be left in place for a month then maxillary first premolars will be extracted and base line records will be taken(digital models, digital periapical radiographs and panorama). digital models will be taken monthly to measure rate of canine retraction for 6 months. after 6 month evaluation of anchorage loss, change in canine tip and torque will be done on last obtained digital model , panorama will be taken to evaluate the change in canine tip and digital periapical radiograph will be taken and compared with the preretraction radiograph to evaluate amount of root resorption.

Eligibility criteria: Inclusion Criteria:

* Adult females (age range 18-28 years old).
* Maxillary dental protrusion indicating first premolars extraction.
* Full permanent dentition (not necessitating third molars).

Exclusion Criteria:

* Patients having systemic diseases or on medications that would affect tooth movement.
* Active periodontal disease or obvious bone resorption in maxillary arch.
* Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting ... etc.).
* Previous orthodontic treatment.
* Missing teeth.

Primary outcomes:
measure: rate of canine retraction
timeFrame: 6 months
Secondary outcomes:
measure: change in canine tip
timeFrame: 6 months
measure: change in canine torque
timeFrame: 6 months
measure: loss of molar anchorage
timeFrame: 6 months
measure: amount of canine root resorption
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of dentistry, Cairo University
Study officials:
References:
Clinical trial NCT03138252: Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin
Official title: Randomized Controlled Trial: Cervical Ripening Balloon With and Without Oxytocin for Cervical Ripening in Multiparas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Ripening
Induction of Labor
Multiparity
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study Purpose: The purpose of this study is to determine the optimal method for induction of labor in multiparous women who present with an unfavorable cervix.

Hypothesis: Our hypothesis is that using oxytocin while the cervical ripening balloon is in place will result in more rapid labor courses, without increasing morbidity or increasing the need for operative delivery.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Gestational age \> 34 + 0/7 weeks
* Prior spontaneous vaginal delivery
* Clinical or U/S EFW of \<4500 grams
* Singleton gestation
* Cervical dilation \<2 cm

Exclusion Criteria:

* Any contraindication to cervical ripening balloon, pitocin, or vaginal delivery
* Placenta within 2 cm of cervical os
* Placental abruption, chorioamninoitis, or systemic infection prior to induction
* Rupture of membranes prior to induction -\>1 prior C/S

Primary outcomes:
measure: Time From Cervical Ripening to Delivery
timeFrame: Time to delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Alison Bauer
state: Ohio
Study officials:
References:
Clinical trial NCT04869852: Effects of Mango Intake on Skin Health and Gut Microbiome Changes in Postmenopausal Women
Official title: Effects of Mango Intake on Skin Health and Gut Microbiome Changes in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Photoaging
Keywords: Wrinkles
Polyphenols
Vitamins
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
Collaborators: name: National Mango Board
First posted: 2021-05-03
Enrollment: 70
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Healthy postmenopausal women aged 50 - 70, Fitzpatrick skin type I, II, or III
Primary purpose: TREATMENT

Brief summary: Mangos are a rich source of nutrients such as carotenoids, vitamin C and fiber, as well as polyphenols and phenolic acids such as mangiferin, ellagic acid, and gallotannins. Mango extract has been reported to protect against photo-aging of the skin in an animal model exposed to UVB radiation, reducing the length of wrinkles and increasing collagen bundles. Beta-carotene and other carotenoids are known to provide skin protection from sunlight, but other compounds in mangos, may also be important in reducing oxidative damage in aging skin.

We have recently completed a pilot study showing a clear trend in skin wrinkle reduction when postmenopausal women consumed 85g of Ataulfo mangos, four times per week for 16 weeks. To confirm and extend these results, a larger study is proposed.


Eligibility criteria: Inclusion Criteria:

* 50 - 70 years old
* Postmenopausal
* Fitzpatrick skin type I, II, or III
* BMI 18.5 - 35
* Must be willing to comply with all protocol requirements
* Must be willing to have flash photo facial images taken with the imaging systems

Exclusion Criteria:

* Smokers
* Allergy to mangos
* Vegans/vegetarians
* Adults unable to consent

Primary outcomes:
measure: Wrinkles
timeFrame: week 20
Secondary outcomes:
measure: Facial Hydration
timeFrame: week 20
measure: Facial Redness
timeFrame: week 20
measure: Facial Elasticity
timeFrame: week 20
measure: Gut microbiome
timeFrame: week 20
measure: Gut microbiome
timeFrame: week 20
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02419352: Sugammadex and Cognitive Function
Official title: Effect of Sugammadex Versus Neostigmine/Atropine Combination on Cognitive Function After Elective Adult Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Cognitive Dysfunction
Keywords: Cognitive function
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 160
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Post operative cognitive dysfunction (POCD) is recognized as a frequent complication after both cardiac and non cardiac surgery, affecting approximately 1/3 of the patients. The aim of this study is to examine the possible effect of the novel reversal agent sugammadex versus neostigmine/ atropine combination on cognitive function of adult patients after elective surgery during the early post operative period as well as at discharge.


Eligibility criteria: Inclusion Criteria:

* Patients aged \>40 years old
* ASA I-III
* Patients scheduled for elective surgery with general anaesthesia.

Exclusion Criteria:

* Neuro-, vascular-, orthopedic- or cardiac surgery
* Known psychiatric or disease of the CNS
* History of craniotomy
* Receiving tranquillisers or antidepressants on a regular basis pre-operatively
* Alcoholism or drug dependence
* History of stroke
* Refusal of patient
* Inability to read or write
* MMSE \< 22 pre-operatively

Primary outcomes:
measure: Change in the Mini-Mental State Evaluation test
timeFrame: Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
measure: Change in the clock-drawing test
timeFrame: Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
measure: Change in the Isaacs set test
timeFrame: Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
Secondary outcomes:
measure: Time from reversal agent administration to extubation
timeFrame: After reversal agent administration
Other outcomes:
Locations:
city: Athens
country: Greece
facility: 2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
Study officials:
References:
Clinical trial NCT04873752: A Study to Investigate the Safety and Efficacy of UC-MSCs in Pediatric Patients With Cerebral Palsy
Official title: An Exploratory Study to Investigate the Safety and Efficacy of UC-MSCs in Pediatric Patients With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cerebral Palsy
Periventricular Leukomalacia
Lead sponsor: Rohto Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-05
Enrollment: 6
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: UDI-001 is administered to pediatric patients with cerebral palsy attributed to periventricular leukomalacia (PVL) multiple times to investigate its safety and efficacy.

Detailed description: This is the first study of UDI-001 to be administered to children. Pediatric patients with cerebral palsy attributed to PVL are enrolled to the study and umbilical cord derived mesenchymal stromal cells (UC-MSCs) are administered to those patients multiple times intravenously. Safety and efficacy of UC-MSCs are evaluated for 52 weeks after the first administration.

Eligibility criteria: Inclusion Criteria:

* Age \>= 12 months and \< 24 months corrected age at the time of informed consent
* Diagnosed with cerebral palsy
* Diagnosed with PVL
* GMFCS level between II and IV
* Able to obtain written informed consent from parents (legal representative)

Exclusion Criteria:

* Presence of progressive neurological disease
* Presence of congenital anomaly
* Diagnosed with Grade 3 or more severe intraventricular hemorrhage
* Body weight \< 5kg
* Profound intellectual disorder
* Complication of serious infection such as sepsis
* Requirement of mechanical ventilation
* Complication of serious organ failure such as kidney, liver or heart diseases or others and considered to be inappropriate
* Diagnosed with or suspected of hypsarrhythmia
* Positive for HBV, HCV, HIV or HTLV-1
* Patients who have received cell therapy
* Patients who have undergone selective dorsal rhizotomy or received botulinum toxin products within a certain period of time

Primary outcomes:
measure: Safety: Adverse Event
timeFrame: until Week 52
Secondary outcomes:
measure: Gross Motor Function Measure Score (GMFM Score)
timeFrame: baseline to Week 52
measure: Gross Motor Function Classification System (GMFCS)
timeFrame: baseline to Week 52
measure: Function Independence Measure for Children (WeeFIM)
timeFrame: baseline to Week 52
measure: Kyoto Scale of Psychological Development Test 2001 (KSPD)
timeFrame: baseline to Week 52
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Osaka City University Hospital
Study officials:
affiliation: Rohto Pharmaceutical Co., Ltd.
name: Sumito Okawa
role: STUDY_DIRECTOR
References:
Clinical trial NCT06537752: A Study to Evaluate Ethanol-induced Symptoms and Safety in Breast Cancer Patients
Official title: A Multi-center, Prospective, Observational stuDy to Evaluate EThanOl-induced Symptoms and Safety in Breast Cancer Patients witH Neoadjuvant/Adjuvant Chemotherapy Including Non-ethanol Formulation Docetaxel Before and After Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-05
Enrollment: 1052
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients in need of neoadjuvant/adjuvant chemotherapy including Non-ethanol formulation docetaxel before and after surgery

Brief summary: The purpose of this study is to evaluate ethanol-induced symptoms and safety in breast cancer patients with neoadjuvant/adjuvant chemotherapy including Non-ethanol formulation docetaxel before and after surgery


Eligibility criteria: Inclusion Criteria:

* Those who voluntarily signed a written personal information collection and usage agreement after receiving an explanation about the objective and method, etc. of this clinical study.
* Those are confirmed to have primary breast cancers through histological diagnosis and one of the following are applicable.

  * Those who need neoadjuvant chemotherapy as breast cancer patients
  * Those who need adjuvant chemotherapy after breast cancer surgery
* Those who are scheduled to administer non-ethanol formulation docetaxel according to chemotherapy
* Those able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion.

Exclusion Criteria:

* Those are diagnosed with other primary cancer that can influence the treatment or prognosis of primary breast cancers.
* Those are diagnosed with secondary breast cancers.
* Those with Stage 0/1 (Tis, N0, M0) or Stage IV (any T, Any N, M1) breast cancers.

Primary outcomes:
measure: Incidence of ethanol-induced symptoms in the initial cycle
timeFrame: From the time of treatment started until the end of follow-up(30 minutes after the treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu Eulji Medical Center, Eulji University
Study officials:
References: