louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03702868: Relationship Between Gut Microbiome and Adjuvant Chemotherapy in Patients With Early Breast Cancer
Official title: A Prospective Cohort Study of Relationship Between Gut Microbiome and Adjuvant Chemotherapy in Patients With Early Breast Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Adjuvant Chemotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-10-11
Enrollment: 226
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: early breast cancer patients ready to receive adjuvant chemotherapy.

Brief summary: Breast cancer is the most common cause of cancer death in women. Adjuvant chemotherapy significantly reduces the risk of recurrence of high-risk breast cancer. However, about 30% of patients still have distant metastasis or local recurrence after chemotherapy. Moreover, 60% of patients had 3-4 degrees of adverse drug reactions during chemotherapy.

The purpose of the study is to investigate relationship between gut microbiome and adjuvant chemotherapy in early breast cancer patients.

Detailed description: Breast cancer is the most common cause of cancer death in women. Adjuvant chemotherapy significantly reduces the risk of recurrence of high-risk breast cancer. However, about 30% of patients still have distant metastasis or local recurrence after chemotherapy. Moreover, 60% of patients had 3-4 degrees of adverse drug reactions during chemotherapy.

The human gut microbiota have been considered the most important microecosystem living in symbiosis with the body. It is identified as a crucial determinant in cancer occurrence and development . Besides, Gut microbial alterations may influence the therapy efficacy and adverse drug event.

We collect the fresh tail stool sample 24h before adjuvant chemotherapy and 24h after adjuvant chemotherapy then the composition of intestinal microbiota and subsequent short-term alterations are analysed by 16srRNA sequencing.The purpose of the study is to investigate relationship between gut microbiome and adjuvant chemotherapy in early breast cancer patients.

Eligibility criteria: Inclusion Criteria:

* Histologically diagnosed stage I-III breast cancer;
* Plan to receive adjuvant chemotherapy in our hospital;
* Sign the informed consent;
* Good compliance and willing to follow up.

Exclusion Criteria:

* Those who have started receiving adjuvant chemotherapy;
* Chemotherapy contraindications;

Primary outcomes:
measure: The incidence of chemotherapy related adverse reaction
timeFrame: 1 years
Secondary outcomes:
measure: disease free survival
timeFrame: 5years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Zhong-yu Yuan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02445768: Functional Connectivity In Relation To Proprioception and Sensorimotor Recovery in Stroke Patients (Feasibility Study)
Official title: Functional Connectivity In Relation To Proprioception and Sensorimotor Recovery in Stroke Patients (Feasibility Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose now is to:

1. identify brain connections related to proprioception to have a better understanding of differences between people with stroke and healthy persons
2. evaluate how these brain connections will change in people with stroke when they are engaged in 6-week cognitive multisensory rehabilitation.


Eligibility criteria: Inclusion Criteria:

Inclusion criteria for healthy subjects are:

* medically stable;
* 18 - 99 years of age;
* able to hear the instructions given during the study

Inclusion criteria for stroke patients are:

* at least 6 months post-stroke;
* medically stable;
* 18 - 99 years of age;
* subcortical or cortical infarct confirmed with MRI;
* Mini-mental State Exam \> 24/30 (Folstein et al., 1975);
* able to hear the instructions given during the study;
* able to comprehend the instructions given during the study;
* able to commit time to participate in a 6-12-weeks rehabilitation program

Exclusion Criteria:

* having ever experienced a stroke or another brain injury or illness related to the brain that has lasting effects or effects experienced at the moment of recruitment;
* severe sensory impairments such that different movements of the finger, hand or wrist are not reliably felt;
* contractures in tested arm that hinder persons from keeping the outstretched arm in a relaxed position;
* interfering comorbidities (e.g. fracture, cancer, peripheral neuropathy);
* exhibit contra-indications to enter the magnetic field of the 3T (pacemakers, metal parts in the body etc);
* pregnant or nursing mother;
* adults lacking capacity to consent

Primary outcomes:
measure: Preliminary study to measure the brain mechanisms of cognitive multisensory rehabilitation
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Anne Van de Winckel, PhD, MS, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van de Winckel A, De Patre D, Rigoni M, Fiecas M, Hendrickson TJ, Larson M, Jagadeesan BD, Mueller BA, Elvendahl W, Streib C, Ikramuddin F, Lim KO. Exploratory study of how Cognitive Multisensory Rehabilitation restores parietal operculum connectivity and improves upper limb movements in chronic stroke. Sci Rep. 2020 Nov 20;10(1):20278. doi: 10.1038/s41598-020-77272-y.
Clinical trial NCT00014768: Study of Metabolic Effects of Pregnancy in Women With Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cystic Fibrosis
Keywords: cardiovascular and respiratory diseases
cystic fibrosis
genetic diseases and dysmorphic syndromes
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: University of Utah
First posted: 2001-04-11
Enrollment: 36
Sex: FEMALE
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: NATURAL_HISTORY

Brief summary: OBJECTIVES: I. Compare the clinical status of pregnant vs non-pregnant women with cystic fibrosis.

II. Determine glucose tolerance during each trimester of pregnancy in these women.

III. Evaluate peripheral insulin sensitivity in these women. IV. Evaluate whole body protein turnover and hepatic glucose production in these women.

V. Determine resting energy expenditure in these women.

Detailed description: PROTOCOL OUTLINE: Patients undergo a glucose tolerance test over 3 hours and a potassium body scan on day 1. Patients undergo an indirect calorimetry over 20 minutes on day 2. Patients receive stable-labeled leucine and stable-labeled glucose IV over 3 hours followed by insulin and glucose IV over 4-4.5 hours on day 2 using the hyperinsulinemic euglycemic clamp technique.

Blood and breath samples are collected to measure glucose tolerance, peripheral insulin sensitivity, and whole body protein turnover. Hepatic glucose production is measured by mass spectrophotometry.

Patients maintain a 3-day food journal before pregnancy, during each trimester, and after pregnancy.

Patients undergo each study during the final 2 weeks of each trimester of pregnancy and then at 6 months post-partum.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of cystic fibrosis (CF) and pregnant OR Age, weight, and body mass index matched non-pregnant CF woman or pregnant non-CF woman
* No infection with Burkholderia cepacia
* FEV1 at least 60%

--Prior/Concurrent Therapy--

* At least 3 weeks since prior corticosteroids

--Patient Characteristics--

* Hepatic: No more than one transaminase level greater than 10% above normal

Other:

Pregnant non-CF controls:

* No cigarette smokers
* No history of gestational diabetes mellitus
* No type 1 or 2 diabetes
* No other chronic illness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
Study officials:
affiliation: University of Utah
name: Dana S. Hardin
role: STUDY_CHAIR
References:
Clinical trial NCT03962972: Association of Centre of Excellence Self-Administered Questionnaire (CESAM) Score and Frailty Levels
Official title: Association of Centre of Excellence Self-AdMinistered Questionnaire (CESAM) Score and Frailty Levels With Incident Adverse Health Events in Older Community Dwellers: Results of the NuAge Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Disease
Frailty
Disability Physical
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2019-05-24
Enrollment: 1741
Sex: ALL
Minimum age (years): 67
Maximum age (years): 82
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Healthy community-dwellers from Quebec, Canada
* A follow-up during 4 years

Brief summary: This study evaluates the association of the Self-Administered questionnaire (CESAM) score and its stratification of frailty in four levels with incident adverse health events in older community dwellers and to compare this association with three validated frailty indexes which are the Cardiovascular Health Study frailty index, Study of Osteoporotic Fracture index and Rockwood frailty index.

Detailed description: Older adults' health and functional status is heterogeneous because of the various cumulative effects of chronic diseases and physiologic decline, contributing to a vicious cycle of increased frailty. Thanks to advances in medicine and hygiene, a growing number of older adults spend more years with a greater range of disorders causing disability but not mortality. Health systems thus need to face this new challenge. Quantification of frailty and its association with the occurrence of adverse health events is crucial to understand how efficiently health systems may respond to this situation.

This study aims to examine the association of the CESAM score and its stratification of frailty in four levels with incident adverse health events in older community dwellers and to compare this association with a) five validated frailty indexes which are the Cardiovascular Health Study frailty index, Study of Osteoporotic Fracture index, Rockwood frailty index, 6-item brief geriatric assessment (BGA) and "Program of Research on the Integration of Services for the Maintenance of Autonomy" (PRISMA-7) and b) two new frailty indexes developed over the COVID-19 pandemic which are "Évaluation SOcio-GÉriatrique" (ESOGER) and "CriblAge et REcommandations" (CARE).

Eligibility criteria: Inclusion Criteria:

-Healthy community-dwellers from Quebec, Canada

Exclusion Criteria:

-Community-dwellers from outside Quebec, Canada

Primary outcomes:
measure: Frailty
timeFrame: the questionnaire will be used once, after 4 years follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Olivier Beauchet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00267072: Ovarian Screening Study
Official title: The University of Louisville Ovarian Screening Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: James Graham Brown Cancer Center
First posted: 2005-12-20
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: The objectives of this study are:

* To identify women at increased risk for developing ovarian cancer
* To detect ovarian cancers at an early stage
* To investigate the role of tumor membrane fragments as tumor markers for early ovarian carcinoma

Detailed description: In the year 2001 approximately 23,400 women in the USA are expected to be diagnosed with ovarian carcinoma and 13,900 will die of the disease. This means that within the USA more women die annually from ovarian cancer than all other gynecologic malignancies combined. Within the Commonwealth of Kentucky approximately 250 women per year develop ovarian carcinoma.

Survival for patients with ovarian cancer is directly related to the stage of disease at diagnosis. Unfortunately, the majority of women present with advanced disease (Stage III and IV) and most of these patients will die of the disease.

The aim of screening for ovarian cancer is to reduce the morbidity and mortality by detecting the disease at an early stage since ovarian cancer detected when disease is confined to the ovary (Stage I) is associated with a dramatically improved 5-year survival. Disease confined to the ovary may be cured in over 90% of patients, in some cases without the need for chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Asymptomatic women over the age of 45 with one or both ovaries.
* Women over the age of 25 with one or both ovaries and any of the following:

  * A personal history of breast, colon or endometrial cancer or breast cancer gene (BRCA) 1 or 2 positive
  * First-degree relative (mother, sister, daughter) with ovarian or breast cancer
  * Two family members with either breast and/or ovarian cancer
  * Mother, sister, daughter, grandparent with a positive BRCA1 or BRCA2 genetic test result.
  * Past use of fertility drugs such as Clomid or Pergonal for more than a year.

Exclusion Criteria:

* Women who are symptomatic of ovarian cancer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
Study officials:
affiliation: University of Louisville, James Graham Brown Cancer Center
name: Cyril W. Helm, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greenlee RT, Hill-Harmon MB, Murray T, Thun M. Cancer statistics, 2001. CA Cancer J Clin. 2001 Jan-Feb;51(1):15-36. doi: 10.3322/canjclin.51.1.15.
Clinical trial NCT00829972: Vitamin D Levels in Children Undergoing Adenotonsillectomies and Controls
Official title: Vitamin D Levels in Children Undergoing Adenotonsillectomies and Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tonsillitis
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2009-01-27
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children age 1-12 years undergoing surgery

Brief summary: The investigators aim to evaluate the levels of serum Vitamin D in children having their tonsils removed and appropriate controls. The investigators hypothesize that children undergoing tonsil removal will have lower Vit D levels than accepted norms and when compared to controls. The investigators also hypothesize that Vitamin D deficiency will correlate with indicators of inflammation such as C-Reactive Protein (CRP) and tonsil size.


Eligibility criteria: Inclusion Criteria:

* children age 1-12 undergoing adenotonsillectomy (active) or elective surgery such as hernia repair (control)

Exclusion Criteria:

* children on systemic steroids or multivitamins containing vitamin D
* control subjects with: a history of snoring, recurrent tonsillitis or score equal to or higher than 5 on the OSA questionnaire.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Fuad M Baroody, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00237172: Phase II Clinical Study of Imatinib Mesylate in Patients With Malignant Gastrointestinal Stromal Tumors (Extension Study)
Official title: Phase II Clinical Study of Imatinib Mesylate in Patients With Malignant Gastrointestinal Stromal Tumors (Extension Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastrointestinal Stromal Tumors
Keywords: GIST
Imatinib
STI571
Gastrointestinal Stromal Tumors
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a extension study of CSTI571B1201 study


Eligibility criteria: Inclusion Criteria:

- Patients who completed the CSTI571B1201 study

Exclusion Criteria:

-

Other protocol-defined inclusion / exclusion criteria may apply.

Primary outcomes:
measure: To study the antineoplastic effect of the investigational drug.
Secondary outcomes:
measure: To study the safety and pharmacokinetics of the investigational drug.
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06360172: The Feasibility of Motivational Interviewing on Emotional Authenticity, Dispositional Optimism, And Academic Motivation Among Nursing Students: A Randomized Controlled Trial
Official title: The Feasibility of Motivational Interviewing on Emotional Authenticity, Dispositional Optimism, And Academic Motivation Among Nursing Students: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nursing Students
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 60
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Motivational interviewing, or MI, is a collaborative, person-centered counseling technique to uncover and enhance a person\&#39;s motivation for behavior change . MI was first created for the treatment of substance dependence, but it has since been successfully implemented in several fields, including healthcare and education (. Given the vital role that nursing students play in the healthcare system, Saudi Arabia, like many other nations, has realized how important it is to improve the motivation and well-being of its nursing students

Detailed description: This study aims to fill the existing research gap by investigating the feasibility of implementing MI techniques to enhance emotional authenticity, dispositional optimism, and academic motivation among nursing students. By focusing on emotional authenticity, dispositional optimism, and academic motivation among nursing students, the study aims to shed light on the effectiveness of MI techniques in addressing the unique challenges faced by this specific population.

Eligibility criteria: Inclusion Criteria:

* Male students to decrease confounding factors, not participating in any type of psychotherapy, and willing to participate in the current study.

Exclusion Criteria:

* Students who complained of any mental disorders or had a previous history of mental problems

Primary outcomes:
measure: Kernis-Goldman Authenticity Inventory
timeFrame: 3 months
measure: The Life Orientation Test-Revised form for Adolescents
timeFrame: 3 months
measure: Academic Motivation Scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Nursing, Alexandria university
Study officials:
References:
Clinical trial NCT04373772: Effect of Abdominal Massage on Bowel Evacuation After Cranial Surgery
Official title: The Effect of Abdominal Massage on Bowel Evacuation After Cranial Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Abdominal Massage
Keywords: Cranial surgery
bowel evacuation
constipation
abdominal massage
nursing
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, parallel, two arm (1:1), randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Many factors in patients undergoing cranial surgery (CS) may affect the bowel evacuation of patients, resulting in constipation, which could lead to the use of the valsalva maneuver. The aim of this study was to determine the effect of abdominal massage (AM) on bowel evacuation of patients treated in intensive care units (ICU) after CS.

Detailed description: The sample of this prospective parallel two-arm randomized controlled trial included 80 patients who underwent CS. The patients were randomly assigned (1:1) to the AM and control groups. The constipation risk of all the patients following CS was assessed with Constipation Risk Assessment Scale (CRAS). Those patients in the AM group received a total of 30 minutes of massage, 15 minutes every morning and evening, until the first defecation. The bowel sounds of all the patients in the AM and control groups were assessed on a daily basis. The days when bowel sounds were heard and the first defecation took place were recorded in a Bowel Evacuation Form.

Eligibility criteria: Inclusion Criteria: Patients who

* volunteered to participate in the study,
* were 18 years old or older and underwent CS,
* stayed in the ICU for ≥ 3 days,

Exclusion Criteria: Patients who

* have percutaneous endoscopic gastrostomy,
* abdominal hernia,
* irritable bowel syndrome
* bowel cancer,
* history of abdominal surgery,
* pregnancy,

Primary outcomes:
measure: Primery outcome: bowel sounds
timeFrame: up to 10 days
measure: Primery outcome: first defecation
timeFrame: up to 10 days
Secondary outcomes:
measure: constipation risk
timeFrame: up to 24 hours
Other outcomes:
Locations:
Study officials:
References: