louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03770793: Effectiveness of Lung Sono in One-lung Ventilation
Official title: Effectiveness of Ultrasound-guided Alveolar Recruitment in Thoracic Surgery With One-lung Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: One Lung Ventilation
Keywords: One lung ventilation
Lung ultrasound
Alveolar recruitment
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 166
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: PREVENTION

Brief summary: To observe the effectiveness of ultrasound-guided alveolar recruitment in thoracic surgery with one-lung ventilation(OLV).

Detailed description: One-lung ventilation(OLV) is essential in thoracic surgery for patient safety and better surgical view. However, pulmonary complications such as hypoxemia may be caused by OLV which might be preventable with adequate alveolar recruitment and positive end-expiratory pressure(PEEP). Alveolar recruitment has been performed with conventional methods without diagnostic tools in clinical setting.

Ultrasound is a non-invasive, radiation-free device with high accuracy for the diagnosis of lung atelectasis. There are a few reports regarding the usefulness of lung ultrasound in other surgeries, but not in thoracic surgeries with OLV.

Thus, investigators designed a study to observe the effectiveness of ultrasound-guided alveolar recruitment in thoracic surgery with OLV.

Eligibility criteria: Inclusion Criteria:

* Elective thoracic surgery which requires one-lung ventilation with lateral decubitus position

Exclusion Criteria:

* Patients who refuse to agree
* Previous lung surgical history
* History of pneumothorax or bullae
* Severe cardiopulmonary disease, COPD
* Operation time \< 1hr

Primary outcomes:
measure: Incidence of desaturation
timeFrame: intraoperative
measure: P/F ratio
timeFrame: 30 minutes after one-lung ventilation
Secondary outcomes:
measure: Lung ultrasound score
timeFrame: just after anesthesia induction, end of surgery
measure: Alveolar dead space
timeFrame: 30 minutes after one-lung ventilation
measure: Pulmonary complications
timeFrame: intraoperative, during hospital stay(an average of 3 days)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong-Hwa Seo, PhD
role: STUDY_CHAIR
References:
citation: Song IK, Kim EH, Lee JH, Kang P, Kim HS, Kim JT. Utility of Perioperative Lung Ultrasound in Pediatric Cardiac Surgery: A Randomized Controlled Trial. Anesthesiology. 2018 Apr;128(4):718-727. doi: 10.1097/ALN.0000000000002069.
Clinical trial NCT06105593: Effect of Balneotherapy and Physiotherapy Treatment in Female Infertility: a Retrospective Study
Official title: Combined Effect of Balneotherapy and Physiotherapy Treatment in Female Infertility at Harkany Thermal Rehabilitation Centre: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Infertility, Female
Keywords: Balneotherapy, Physiotherapy, Questionnaire, Infertility
Lead sponsor: Harkány Thermal Rehabilitation Centre
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 577
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In the period between July 1, 2007 and December 31, 2021, received a 3-week complex balneotherapy and physiotherapy treatment at the Harkany Thermal Rehabilitation Center in inpatient care

Brief summary: The goal of this observational study is to assess the effect of complex balneotherapy and physiotherapy treatment among infertile women treated in the Harkany Thermal Rehabilitation Center between July 01, 2007 and December 31, 2021. The main questions it aims to answer are:

* To what extent can the complex balneotherapy and physiotherapy treatment be an effective additional therapy in female infertility?
* What are the clinical changes behind infertility that can be helped by the complex balneotherapy and physiotherapy treatment? Participants will be asked to answer a questionnaire that we have prepared.


Eligibility criteria: Inclusion Criteria:

* Female gender
* Diagnosed primary or secondary infertility

Exclusion Criteria:

* Lack of cooperation

Primary outcomes:
measure: successful conception
timeFrame: 12 months
Secondary outcomes:
measure: successful delivery
timeFrame: 12 months
measure: the effect of the treatments on successful conception in different causes of infertility
timeFrame: 12 months
Other outcomes:
Locations:
city: Harkány
country: Hungary
facility: Harkany Thermal Rehabilitation Center
Study officials:
affiliation: Harkany Thermal Rehabilitation Center
name: Eszter Ambrus
role: PRINCIPAL_INVESTIGATOR
affiliation: Harkany Thermal Rehabilitacion Center
name: Nóra Nusser
role: STUDY_DIRECTOR
References:
Clinical trial NCT06383793: Comparative Analysis of Short-Term Therapeutic Effects Between the π-Shaped and Overlap Methods for Esophagogastrostomy in Totally Laparoscopic Total Gastrectomy
Official title: Comparative Analysis of Short-Term Therapeutic Effects Between the π-Shaped and Overlap Methods for Esophagogastrostomy in Totally Laparoscopic Total Gastrectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: preoperative confirmation through electronic gastroscopy and enhanced CT that the lesion was situated in the fundus, middle and upper third of the gastric body, or the entire stomach

Brief summary: As of now, although the safety of π-shaped anastomosis and the overlap method has been separately discussed in different contexts, there have been few studies considering a direct comparison of the results of these two methods.

This article aims to explore the differences in the short-term therapeutic effects, surgical effectiveness, and safety between laparoscopic total gastrectomy with esophagogastrostomy using the overlap method and the π-shaped method. The goal is to provide new reference points for surgeons in the clinical decision-making process regarding the choice of anastomotic techniques during totally laparoscopic total gastrectomy.


Eligibility criteria: Inclusion Criteria:(1) preoperative confirmation through electronic gastroscopy and enhanced CT that the lesion was situated in the fundus, middle and upper third of the gastric body, or the entire stomach; (2) postoperative pathology confirming adenocarcinoma; (3) utilization of either overlap esophagojejunal anastomosis or π-shaped anastomosis in total laparoscopic total gastrectomy.

-

Exclusion Criteria:(1) patients with severe preoperative cardiac, hepatic, renal, and pulmonary complications; (2) preoperative neoadjuvant chemotherapy; (3) a history of previous abdominal surgery; (4) patients requiring combined resection due to infiltration of other organs during the operation; (5) patients with incomplete pathological or clinical data. All patients signed informed consent.

-

Primary outcomes:
measure: 1 year survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Yifan Cheng
state: Jiangsu
Study officials:
References:
Clinical trial NCT02455193: Neuronal Effects of Exercise in Schizophrenia
Official title: Neuronal Effects of Exercise in Schizophrenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2015-05-27
Enrollment: 140
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study plans to learn more about how common drugs prescribed to individuals with schizophrenia contribute to weight gain, as well as how exercise and diet impact appetite and the brain's response to food. In this study, the investigators will be evaluating how participants' brains respond to food images as well as asking questions about their food preferences and intake and clinical symptoms. The investigators may also ask participants to complete an exercise or diet intervention to see how this changes brain responses or food preferences.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder
* Between 21 and 70 years of age
* Currently prescribed either olanzapine, risperidone, clozapine, or haloperidol, OR not currently being treated with any neuroleptic medications
* Weight stable within 5 percent for the last 6 months

Exclusion Criteria:

* Pregnancy
* Substance abuse
* Significant endocrine/metabolic disease (e.g., uncontrolled hypertension, severe hypertriglyceridemia)
* MRI-specific exclusion criteria (e.g., claustrophobia, metal in the body)

Primary outcomes:
measure: Neuronal response to visual food cues
timeFrame: 14 weeks
measure: Resting-state neuronal response
timeFrame: 14 weeks
Secondary outcomes:
measure: Appetite Rating on a visual analogue scale (VAS)
timeFrame: 14 weeks
measure: Fasting leptin
timeFrame: 14 weeks
measure: Fasting ghrelin
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jason Tregellas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02374593: Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism
Official title: Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Hypothyroidism
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 24
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a clinical study comparing targeted levothyroxine dosing based on thyroid anatomy as visualized on ultrasound (normal vs. ectopic/sublingual vs. athyreosis) to empiric levothyroxine dosing in infants with congenital hypothyroidism. Patients enrolled in the study for targeted dosing will be compared to controls obtained by retrospective chart review. The main outcome is to determine if there is a difference in the frequency of over-treatment and under-treatment during the first 6 months of therapy.


Eligibility criteria: Inclusion Criteria:

* Newborns diagnosed with congenital hypothyroidism (CH).
* Newborns with CH who are treated by a pediatric endocrinologist at Riley Hospital for Children or satellite location.
* Newborns with CH who have thyroid imaging performed (thyroid ultrasound or technetium scan) at diagnosis.

Exclusion Criteria:

* Newborns who do not have CH.
* Newborns with CH who have not had thyroid imaging performed at diagnosis.

Primary outcomes:
measure: Dose Adjustments
timeFrame: 6 months
Secondary outcomes:
measure: Number of Adjustments Due to Overtreatment in Subjects With Athyreosis, Ectopic and Eutopic Thyroid Glands Compared With Controls
timeFrame: 6 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
Study officials:
affiliation: Indiana University
name: Erica Eugster, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02313493: Efficacy and Feasibility of Baby Triple P - a Pilot Study
Official title: Improving Mental Health in First Time Parents - A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Disorders During Pregnancy
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2014-12-10
Enrollment: 78
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In the present pilot study the feasibility and efficacy of Baby Triple P- an antenatal parent training- are investigated. Healthy becoming first time parents were randomly allocated to either the Baby Triple P parent-training group or a care as usual control group. It is expected that 78 couples of becoming first time parents are recruited. It is hypothesized that parents and their infants in the parent training group will show significantly less psychopathology / regulation problems and better partnership quality than participants in the control condition.

Detailed description: In this pilot study, the efficacy and feasibility of the Baby Triple P parenting training is investigated in a pilot study using a randomized controlled trial. According to the efficacy of the parenting training, it is expected that parents in the training condition show higher scores on mental health scales (BSI-18) and quality of Partnership (PFB). Furthermore, it is expected that infants whose parents has taken part in the parenting training have lower severity ratings of regulatory disorders assessed with the Baby-DIPS diagnostic interview than infants of parents in the care as usual control condition.

Eligibility criteria: Inclusion Criteria:

* Becoming first time parent
* Participants have a basic level of German literacy which allows them to understand the Baby Triple P materials
* Unborn Baby is developing well and does not have a pre-diagnosed medical condition

Exclusion Criteria:

* Baby has a disability or pre-diagnosed medical condition.
* The parents are intellectually disabled

Primary outcomes:
measure: Number of symptoms on the BSI 18 and the PFB-K
timeFrame: Before birth (T1), two months after birth (T2)
measure: Severity rating (0-8) of regulatory problems in infants
timeFrame: six months after birth (T3)
Secondary outcomes:
measure: Quality of parenting
timeFrame: Two months after birth (T2), six month after birth (T3)
measure: Number of symptoms on the EPDS, DASS-21 and the OSS-3
timeFrame: Two months after birth (T2)
Other outcomes:
Locations:
Study officials:
References:
citation: Popp L, Fuths S, Schneider S. The Relevance of Infant Outcome Measures: A Pilot-RCT Comparing Baby Triple P Positive Parenting Program With Care as Usual. Front Psychol. 2019 Oct 29;10:2425. doi: 10.3389/fpsyg.2019.02425. eCollection 2019.
citation: Popp L, Schneider S. Attention placebo control in randomized controlled trials of psychosocial interventions: theory and practice. Trials. 2015 Apr 11;16:150. doi: 10.1186/s13063-015-0679-0.
Clinical trial NCT05590611: Impact of Sourdough Bread Consumption on Long-term Energy Intake: A Pilot Study of Feasibility
Official title: Impact of Sourdough Bread Consumption on Long-term Energy Intake: A Pilot Study of Feasibility (SOBER)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Appetite Regulation
Energy Intake
Body Weight Changes
Eating Behavior
Overweight and Obesity
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study is a pilot study examining whether long-term sourdough bread consumption reduces energy intake and blood lipids levels over a period of 4 weeks in free-living normalweight and overweight participants.


Eligibility criteria: Inclusion Criteria:

* Female and male participants
* Age range 18 - 50
* BMI range \>20 kg/m2 at screening visit
* Regular eating pattern (3 meals per day on at least 5 days per week)
* Habitual brown bread consumption of at least 1 slice per day (assessed by The European Prospective Investigation into Cancer (EPIC) Norfolk FFQ)
* Stable body weight for the last 6 months

Exclusion Criteria:

* Currently smoking or willingness to smoke during the study period
* Pregnancy, lactation or wish to become pregnant during the study period
* Previous or current gastrointestinal or endocrine disorders
* Previous or current substance/alcohol dependence or abuse (\> 2 units per day/14 units per week)
* Coeliac disease or gluten sensitivity
* Allergy/intolerance to milk, egg, nuts, soy or sesame
* Habitual sourdough bread consumption of at least 1 slice per day (assessed by The European Prospective Investigation into Cancer (EPIC) Norfolk FFQ)
* Excessive concern about eating habits or body weight as evidenced from scores \< 18 on the restraint and disinhibition subscales of the Three-Factor Eating Questionnaire (Stunkard \& Messick, 1985)

Primary outcomes:
measure: Energy intake (kilocalories)
timeFrame: 4 weeks
Secondary outcomes:
measure: Body weight
timeFrame: 4 weeks
measure: Blood lipid levels
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
state: Vlaams Brabant
Study officials:
affiliation: KU Leuven
name: Kristin Verbeke
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00671411: Evaluating Renal Masses Using Ultrasound Intravenous Microbubble Contrast
Official title: Evaluation of Renal Masses Using Ultrasound Intravenous Microbubble Contrast
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Cancer
Kidney Cancer
Keywords: Ultrasound
07-165
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-05-05
Enrollment: 42
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the blood flow in kidney masses by using ultrasound microbubble contrast material, and to see if results from ultrasound contrast studies can predict if a kidney mass is benign or malignant. Patterns of blood flow in the kidney mass will be examined to see if:

1. benign kidney masses can be distinguished from kidney cancers and
2. if slow growing, lower risk cancers have different blood flow compared to clear cell cancer which is the most common type of kidney cancer.


Eligibility criteria: Inclusion Criteria:

* Any adult patient who is planned or scheduled for surgical excision or biopsy of a solid or complex cystic renal mass would be eligible for the study
* Histology of the renal mass must be unknown at the time of enrollment
* Patients who have renal masses that are evident on conventional US imaging
* Patients will have a correlative abdominal CT and/or MRI

Exclusion Criteria:

* Patients with any history of cardiac shunts.
* Patients with history of pulmonary hypertension or unstable cardiopulmonary conditions, including patients on mechanical ventilation.
* Patients without peripheral IV access
* Pregnant patients and children
* Patients with any known contrast allergies, allergy to perflutren, or any components of Definity or microbubble contrast
* Patients who have renal masses that are not evident on conventional US imaging

Primary outcomes:
measure: To determine the accuracy of contrast enhanced ultrasound of renal masses to predict benign vs. malignant histology
timeFrame: conclusion of study
Secondary outcomes:
measure: To determine if clear cell renal malignancies can be predicted, or differentiated, from other less aggressive malignant subtypes, based on analysis of the data.
timeFrame: conclusion of study
measure: To determine if contrast enhanced ultrasound of renal masses provides added value in predicting benign vs. malignant histology, when compared to the current routine evaluation of CT or MRI, and standard grey scale and Doppler US
timeFrame: conclusion of the study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Scott Gerst, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02934711: A Quality Rating Scale for Patients in Complex Situations and Their Caregivers
Official title: Establish a Quality Rating Scale for Primary Care Centers and Nursing Homes Pluri Professionals Integrating the Perspective of Patients in Complex Situations and Their Caregivers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients in Complex Situations
Keywords: Multimorbidity
Exercise coordinated groups (GECO)
Caregivers
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-10-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In each of exercise coordinated groups (GECO), it will be important to obtain a variety of cases studied in terms of socio-demographic characteristics (although populations of the basins of different exercise coordinated groups may have more or less specific profiles, to be taken into account) and range previous care.

The population of multimorbid patients and caregivers will be vary with regard to age, sex, place of residence (living alone or cohabiting with relatives or hosted) and professional categories

Brief summary: Identify and analyze in the exercise groups coordinated (GECO) the effects of coordination arrangements between professionals on the transformation of modes of exercise of professional care, and on the experience of patients / users and that of caregivers, particularly on dimensions constituted that the quality of care in order to build a coordinated exercise structures rating scale primary care on the basis of criteria suggested by patients


Eligibility criteria: Inclusion Criteria:

* For Professionals:
* Medical or paramedical professionals working in the exercise coordinated groups (GECO) initially defined
* Professionals who made his non_opposition
* For patients and family caregivers:
* Binomials patients / caregivers over the age of 18.
* Binomials patients / caregivers who formulated his non_opposition
* Patients experiencing complex care (multi-morbid and chronic)

Exclusion Criteria:

* Refusal of a participant (Professionals / Patients / caregivers) to respond to inquiries

Primary outcomes:
measure: A quality assessment scale
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Faou
country: France
facility: Maison de santé de l'Aulne Maritime du Faou
Study officials:
References: