louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02109588: Early Prevention of Childhood Obesity: an Active Pregnancy
Official title: Early Prevention of Childhood Obesity: an Active Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Lead sponsor: Technical University of Madrid
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 1100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main aim of this study was to examine the effect of a supervised physical exercise program on the prevention of childhood obesity and its impact on the motor development of the offspring.

Detailed description: The environment where the fetus growths up is essential for the risk of developing some diseases in later life, such as obesity. Exercise has showed being useful in the prevention on excessive maternal weight gain which is linked to fetus weight.

Eligibility criteria: Inclusion Criteria:

* Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
* Being able to communicate in spanish
* Giving birth at Hospital Universitario de Torrejón, hospital Universitario de Puerta de Hierro and Hospital Universitario Severo Ochoa (Madrid).

Exclusion Criteria:

* Multiparity
* Obstetrician complications
* Being interested in the study after 16 weeks
* Not being regular in physical exercise program
* Younger than 18 years old

Primary outcomes:
measure: Body mass index of the offsprings
timeFrame: 0-24 postpartum months
measure: Fetus body composition
timeFrame: 0-24 postpartum months
measure: Change from baseline in Maternal gestational weight gain
timeFrame: 40-42 weeks of gestation
measure: Changes in Baby motor development
timeFrame: 0-24 postpartum months
measure: Recovery time to pre-gestational weight
timeFrame: 6-12 postpartum months
measure: Glycemia level of the offsprings
timeFrame: 0-24 postpartum months
measure: Postpartum depression
timeFrame: 0-12 postpartum months
measure: Change from baseline in Body image satisfaction
timeFrame: up to 36 weeks
measure: Changes from baseline in maternal quality of life
timeFrame: up to 36 weeks
measure: Placenta measurements
timeFrame: At delivery
Secondary outcomes:
measure: Maternal outcomes
timeFrame: At delivery
measure: Control of physical activity
timeFrame: up to 10 weeks
measure: Changes from delivery in Health of the offspring
timeFrame: 0-24 postpartum months
measure: Fetus outcomes
timeFrame: At delivery
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Politécnica de Madrid
Study officials:
affiliation: Universidad Politecnica de Madrid
name: Rubén Barakat, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00537888: Clinical Significance of Smear or Culture Positive for Candida Spp. From Sputum Three Times a Week
Official title: Diagnosis of Pulmonary Candidiasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pulmonary Candidiasis
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2007-10-02
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The definition of pulmonary candidiasis is still unclear.In China, isolation of candida spp. form sputum twice or three times a week has been regarded as the microbiological evidence of pulmonary candidiasis. The investigators hypothesize that patients who present respiratory symptoms and lung infiltrates together with smear of culture positive for candida spp. from sputum three times a week can not be diagnosed as pulmonary candidiasis.


Eligibility criteria: Inclusion Criteria:

* 85ys\>age\>14ys
* APACHE II\<25
* Lung infiltrates together with at least one of the following symptoms:cough, sputum, dyspnea with or without fever
* smear or culture positive for candida spp. from sputum

Exclusion Criteria:

* Pregnancy
* Hypersensitivity to fluconazole
* Isolated candida was non-sensitive to fluconazole
* Severe liver or renal diseases who can not tolerate fluconazole treatment
* With at least one of the following high risk factors:organ transplantation, neutropenia\>10ds, long term glucocorticoids therapy(equal to prednisone 30mg/d longer than 2 weeks), immunosuppressive therapy within 30ds, AIDS
* With one of the microbiological evidence:isolation of candida spp. from blood or other kinds of sterile site(not including urine), filamentous fungi isolated from sputum or BALF, cryptococcus isolated from sputum or CSF, galactomannan antigen positive twice for blood
* Probable or possible pulmonary aspergillosis
* Definite oral or esophageal candidiasis

Primary outcomes:
measure: invasive candidiasis
timeFrame: in hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital,Affiliate of Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Chaoyang Hospital, Affiliate of Capital Medical University
name: Bin Cao, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cao B, Cai BQ, Wang H, Zhou CY, Wang P, Liu HR, Zhang H, Xu L, Xu KF, Xu WB, Zhu YJ, Li XG. [A study of 152 cases of pulmonary fungal infection: reevaluation of the microbiological spectra]. Zhonghua Jie He He Hu Xi Za Zhi. 2007 Apr;30(4):279-83. Chinese.
Clinical trial NCT04010188: A Registered Cohort Study on Charcot-Marie-Tooth Disease
Official title: A Registered Observational Cohort Study of Charcot-Marie-Tooth Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Charcot-Marie-Tooth Disease
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CMT patients who are diagnosed in the First Affiliated Hospital of Fujian Medical University.

Brief summary: The aim of the study is to analyze the natural history data data from Charcot-Marie-Tooth disease and related disorders in China, to assess the clinical, genetic, epigenetic features of patients with Charcot-Marie-Tooth disease, and to optimize clinical management.


Eligibility criteria: Inclusion Criteria:

* Patients with the clinical diagnosis of Charcot-Marie-Tooth disease
* Genetic diagnosis of patients with Charcot-Marie-Tooth disease
* Unrelated healthy controls

Exclusion Criteria:

* Decline to participate.
* Other peripheral neuropathy caused by trauma, immunity and toxicosis.

Primary outcomes:
measure: The change of Charcot-Marie-Tooth Neuropathy Score (CMTNS) during 6 month
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: First Affiliated Hospital of Fujian Medical University
Study officials:
References:
Clinical trial NCT04958278: Pelvic Sentinel Node Detection Using Indocyanine Green Learning Curve
Official title: Pelvic Sentinel Node According to SHREC-trial for the Application of the 2021 European Recommendations for Lymph Node Staging Strategy in Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Cancer
Keywords: endometrial cancer
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 patients over 18 months total duration of the study 20 months

Brief summary: According to ESGO-ESTRO-ESMO guidelines, pelvic Sentinel lymph node detection is suitable for lymph node staging in endometrial carcinoma of the uteri.

Nonetheless, a learning curve is mandatory to ensure the surgical quality of the sampling.

The aim of the study is to assess the success of sentinel lymph node detection according to SHREC-Trial surgical strategy.

Detailed description: Introduction:

According to ESGO-ESTRO-ESMO guidelines, pelvic Sentinel lymph node detection is suitable for lymph node staging in endometrial carcinoma of the uteri.

The aim of the study is to assess the success of sentinel lymph node detection according to SHREC-Trial surgical strategy.

Patients and Method:

All patients presenting with early FIGO stage and low, intermediate, high intermediate or high risk endometrial carcinoma will be prospectively enrolled.

Sentinel lymph node mapping will be performed using laparoscopic approach and cervical Indocyanine Green injection.

Based on the surgical algorithm for detection of pelvic sentinel lymph node in endometrial cancer from Persson and coll., we designed a study with a target of 70% to 90% of bilateral detection rate .

Thirty patients will be included over 18 months.

Eligibility criteria: Inclusion Criteria:

Letter of non objection Endometrial carcinoma Stage FIGO I-II whatever the histological subtype. ESGO-ESMO-ESTRO 2021 risk classification : low, intermediate, high intermediate, high Laparoscopic approach.

Exclusion Criteria:

Participation refusal Medical contraindication to laparoscopic approach. Stage FIGO \> II Suspected Indocyanine Green allergy

Primary outcomes:
measure: Bilateral node detection rates
timeFrame: Day 0 (during surgery)
Secondary outcomes:
measure: sentinel nodes
timeFrame: Day 0 (during surgery)
measure: Salvage operations in case of GS failure
timeFrame: Day 0 (during surgery)
measure: adverse events
timeFrame: Day 30
measure: factors for detection failure
timeFrame: Day 0 (during surgery)
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT02366078: Stress Management Training for School Staff
Official title: The Efficacy of Using Blended Learning With the Stress Management and Resilience Training (SMART) Program to Decrease Stress and Enhance Resilience in Public School Staff
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-02-19
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the outcomes of the Stress Management and Resiliency Training (SMART) program among Public School staff in 2 communities in Minnesota. Feasibility of a blended in-person and online teaching approach of the program will also be evaluated.

Detailed description: The purpose of this study is to investigate the outcomes of the Stress Management and Resiliency Training (SMART) program among Public School staff in 2 communities in Minnesota. Feasibility of a blended in-person and online teaching approach of the program will also be evaluated.

This study builds on previous work in other working populations with high stress levels inherent in the specific work process.

Eligibility criteria: Inclusion Criteria:

* Public school teacher
* Able tor read English

Exclusion Criteria:

* Unable to read English

Primary outcomes:
measure: Self reported stress level
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Brent Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06669078: NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX as Conversion Therapy of Locally Advanced Pancreatic Cancer
Official title: A Prospective, Open, Randomized Controlled, Multicenter, Exploratory Clinical Study of NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX for Conversion Therapy for Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Locally Advanced Pancreatic Cancer
Keywords: NALIRIFOX
Conversion Therapy
Locally Advanced Pancreatic Cancer
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 120
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: The purpose of the prospective, open, randomized controlled, multicenter, exploratory clinical study is to evaluate efficacy and safety of NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX for Conversion Therapy for Locally Advanced Pancreatic Cancer


Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically confi rmed pancreatic cancer;
2. ECOG performance no more than 1;
3. Radiographically assessed as locally advanced pancreatic cancer according ;
4. No previous anti-tumor therapy;
5. Able and willing to provide a written informed consent.

Exclusion Criteria:

1. Prior anti-tumor therapy of any kind;
2. Known to be symptomatic central nervous system metastasis and/or cancerous meningitis.
3. Patients with autoimmune disease or immune deficiency who are treated with immuno-suppressive drugs;
4. Patients with bleeding tendency;
5. Pregnant or lactating women.

Primary outcomes:
measure: 1 year OS rate
timeFrame: Up to 12 months]
Secondary outcomes:
measure: R0/R1 rate
timeFrame: Up to 6 months
measure: The rate of mPR
timeFrame: Up to 6 months
measure: OS
timeFrame: Up to 24 months
measure: ORR
timeFrame: Up to 6 months
measure: PFS
timeFrame: Up to 12 months
measure: Surgical resection rate
timeFrame: Up to 6 months
measure: The incidence of grade 3 or higher AE and serious adverse event(SAE) [Safety]
timeFrame: From the first treatment to 28 days after the last treatment, about 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02966678: Incidence of Dyschromatopsia in Glaucoma
Official title: Incidence of Dyschromatopsia in Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Keywords: Glaucoma, Dychromatopsia
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-11-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of glaucoma from a university outpatient department

Brief summary: Incidence of dyschromatopsia

Detailed description: Incidence of dyschromatopsia should be elevated in glaucoma compared to a healthy control population. However, the actual incidence rate is not investigated.

Eligibility criteria: Inclusion Criteria:

* diagnosis of glaucoma
* age between 18 and 99 years old
* best corrected visual acuity(BCVA) \> 0.2 (decimal Snellen)

Exclusion Criteria:

* age \< 18 yo
* BCVA \< 0.2
* known dyschromatopsia
* known corneal disease
* St.p. corneal surgeries
* macula disease
* history of medication use that can influence color vision (e.g. hydroxychloroquine)

Primary outcomes:
measure: Incidence of dyschromatopsia
timeFrame: first and only study visit (day 1 of the study)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UniversityHospital Zurich, Dept. of Ophthalmology
name: Jens Funk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00421278: The Effect of MK 0633 in Patients With Atherosclerosis (0633-008)(COMPLETED)
Official title: A Clinical Study to Evaluate the Efficacy and Safety of MK0633 in Patients With Atherosclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atherosclerosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 180
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A study to test the effects of study drug (MK 0633) on patients with Atherosclerotic disease


Eligibility criteria: Inclusion Criteria:

* Patients with plaque in coronary or leg arteries, known as atherosclerosis or peripheral vascular disease
* Inflammatory marker found in your blood, known as hsCRP \> 0.5 mg/L

Exclusion Criteria:

* Age \< 40 or \> 85
* Female
* Heart attack, coronary artery bypass, stroke or unstable angina in last 3 months
* Liver diseased or abnormalities
* HIV infection
* Lupus, rheumatoid arthritis, cancer \<5 years

Primary outcomes:
measure: To evaluate the effects of the drug, MK 0633, on an inflammatory marker in your blood that may affect the plaque in the arteries, know as atherosclerosis
timeFrame: 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04572178: Cash Payment and Counseling During Pregnancy
Official title: Cash Payment and Counseling for Quitting Smoking During Pregnancy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Pregnancy Related
Incentives
Keywords: Smoking cessation
Pregnancy
Incentives
Counseling
Cash payment
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: Liselotte-Beutel-Foundation
name: Ministry of Social Affairs, Integration and gender Equality
First posted: 2020-10-01
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Smoking during pregnancy has harmful effects on both mother and unborn child. Studies have shown that small rewards can help smokers to quit. In our current study, we ask how such rewards are most effective in supporting smoking cessation in pregnancy.

Detailed description: We would like to include up to 15 pregnant women. Inclusion criteria are: (i) current pregnancy, between pregnancy week 15 and 23 and, (ii) current smoking of at least one cigarette per day. After an initial survey, the participating women are scheduled twice a week for counseling and evaluation of their smoking status.They will receive cash payment of 25 Euro if her carbon monoxide reading does not exceed the value "3", on two consecutive dates per week. A second survey will be conduced in pregnancy week 36 and a third survey, eight weeks postpartum.

Eligibility criteria: Inclusion Criteria:

* Current smoking, at least one cigarette per day
* Pregnancy, between pregnancy week 15 and 23

Exclusion Criteria:

* Inadequate language skills
* Cognitive impairment

Primary outcomes:
measure: Drop-out rate
timeFrame: Baseline up to pregnancy week 36
Secondary outcomes:
measure: Differences in number of cigarettes per day by self report
timeFrame: Baseline up to pregnancy week 36
measure: Attempts to stop smoking by self report
timeFrame: Baseline up to pregnancy week 36
measure: Attempts to stop smoking by carbon monoxide measurement
timeFrame: Baseline up to pregnancy week 36
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Institute for Comunity Medicine, Department Prevention Research and Social Medicine
Study officials:
affiliation: University Medicine Greifswald, Dep. Prevention Research and Social Medicine
name: Sabina Ulbricht, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05253378: Development and Validation of a Comorbidity Index in Crohn's Disease
Official title: Development and Validation of a Comorbidity Index in Crohn's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CD patients

Brief summary: Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD). Like other chronic diseases, patients with CD may be affected by other diseases called comorbidities. The prevalence of comorbidities in IBD patients ranges from 30 to 70 %. Unlike other chronic diseases, there is currently no CD-specific tool to assess the impact of comorbidities on patients' lives in order to take appropriate medical measures. Several clinical indexes have been developed for the study of comorbidities, including the Charlson index and the Groll index, which are widely used. The disadvantage of these indexes is that they are not adapted to patients with CD. The primary objective of this study is to develop and validate a clinical index to evaluate the impact of comorbidities on disability in patients with CD.


Eligibility criteria: Inclusion Criteria:

1. Patients between 18 and 59 years old
2. Established diagnosis of CD with a minimum disease duration of 3 months
3. Disease considered by the treating gastroenterologist to have been stable for at least 3 months

Exclusion Criteria:

1. Subject unable to comply with study procedures
2. Surgery for CD 3 months prior to inclusion visit

Primary outcomes:
measure: To develop and validate a clinical index to evaluate the impact of comorbidities on disability in patients with CD.
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre-lès-Nancy
country: France
facility: Laurent PEYRIN-BIROULET
city: Milano
country: Italy
facility: San Raffaele Hospital
Study officials:
References:
Clinical trial NCT03135678: Study to Verify the Feasibility of Collecting a Broad Variety of Individual Health Data
Official title: Observe Pilot, a Prospective Study to Verify the Feasibility of Collecting a Broad Variety of Individual Health Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Hilbert Paradox NV
Sponsor class: INDUSTRY
First posted: 2017-05-01
Enrollment: 12
Sex: ALL
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: The population is a healthy population.

Brief summary: The purpose of the OBSERVE PILOT is to verify the feasibility of collecting individual health data which is obtained through blood samples, continuous monitoring devices, medical imaging, a questionnaire, and a blood pressure monitor.

Feasibility of collecting individual health data within the OBSERVE PILOT is described as the ease of gathering a broad variety of data by assessing: (1) the willingness of the subjects to participate in the study, (2) the logistics corresponding with the variety, and (3) the regulatory aspects of gathering a broad variety of data.


Eligibility criteria: Inclusion Criteria:

* The subject is able and willing to provide written informed consent prior to research specific data collection.
* The subject must be older than 18 years old.

Exclusion Criteria:

* The subject should not suffer from glaucoma.
* The subject should not be allergic to eye drops.

Primary outcomes:
measure: The number of subjects willing to join the study
timeFrame: Through study completion, an average of 6 months
measure: The number of health data types that were measured
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: General Practice
Study officials:
affiliation: Director at Hilbert Paradox
name: Stefan Verheye, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: