louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03002337: Efficacy of the Yoga and Aromatherapy on Salivary Hormone and Immune Function in Pregnant Women.
Official title: Yoga and Aromatherapy on Salivary Hormone and Immune Function in Pregnant Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychologic
Keywords: aromatherapy massage, yoga
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 75
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study's aims are to examine the effects of yoga and aromatherapy on women's stress and immune function during pregnancy.

Detailed description: This longitudinal, prospective, randomized controlled trial recruited 75 healthy pregnant women from a prenatal clinic in Taipei using convenience sampling. The participants were randomly assigned to the aromatherapy group (n=25), yoga group (n=25) or control (n=25) group using Clinstat block randomization.

The aromatherapy group received 70 minutes of aromatherapy massage once biweekly for 20 weeks; the yoga group participated in two weekly 70-minute yoga sessions led by a midwife certified as a yoga instructor for 20 weeks; the control group received only routine prenatal care. All participants' salivary cortisol and immunoglobulin A levels were collected before and after yoga or aromatherapy every 4 weeks from 16 to 36 weeks' gestation.

To collect a sufficient quantity of saliva, we used Salivette® cotton swabs (Salimetrics, State College, PA, USA), which were stored in double-layer plastic tubes with a lid. When participants chew a swab for about 2 to 3 minutes, saliva flow is stimulated to a sufficient amount (1 mL) for collection. After the tube was centrifuged at 1000 x g for 2 minutes, saliva was stored at -80°C until assay for salivary cortisol and IgA concentrations.

Cortisol was measured using a competitive enzyme-linked immunoassay (ELISA) kit (Cayman Chemical Company, USA), and salivary IgA was measured using double-antibody sandwich ELISA method per the manufacturer's instruction (ICL, Inc., USA).

Eligibility criteria: Inclusion Criteria:

* Normal pregnancy
* Age 20-45 years
* Agreed to follow-up collections of saliva samples
* Could read and write Chinese

Exclusion Criteria:

* Oral steroid use
* History of severe illness (e.g., heart disease, systemic lupus erythaematosus, metabolic disorders) or depression.
* Drug use (prescribed or illicit).
* High-risk pregnancy (i.e., first-trimester vaginal bleeding, artificially insemination, multiple gestations, foetal growth restriction or other abnormalities).

Primary outcomes:
measure: Physiological parameter (salivary cortisol)
timeFrame: 20 weeks
Secondary outcomes:
measure: Physiological parameter (salivary IgA)
timeFrame: 20 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01231737: Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)
Official title: Efficacy of Prulifloxacin vs Phosphomycin in the Prophylasy of Urinary Tract Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Urinary Tract Infection
Keywords: Prophylasy
recurrent urinary tract infection
prulifloxacin
phosphomycin
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2010-11-01
Enrollment: 96
Sex: FEMALE
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: Epidemiological studies showed that 20-30% of patients with uncomplicated urinary tract infections risked recurrent infection. Urinary tract infection causes marked discomfort for the patient, has a negative impact upon quality of life, and is associated with high social and health costs in terms of specialist appointments, laboratory and instrumental tests and prescriptions . Although diverse cycles of antibiotic therapy and prophylaxis have been proposed, doubts persist about the most efficacious pharmacological agents, duration of prophylaxis , the incidence of adverse effects and relapse when antibiotic therapy is suspended.

Aims of the study:

1. To compare the efficacy of two prophylactic schedules (Prulifloxacin vs Phosphomycin):

   * in reducing the number of urinary tract infection episodes during prophylaxis
   * in reducing the number of urinary tract infection episodes after prophylaxis
   * in improving the patient's quality of life .
2. To assess :

   * Tolerability of antibiotic prophylaxis
   * The incidence of resistance to antibiotic therapy


Eligibility criteria: Inclusion Criteria:

* Female patients
* Age over 18 years old
* No allergies to the drugs to be prescribed
* No counter-indications to this drug therapy
* Urine culture shows responsiveness to drugs at recruitment of patient
* History of urinary tract infections with at least three episodes in the previous year or two in the past six months

Exclusion Criteria:

* Lack of tolerability of prescribed drugs

Primary outcomes:
measure: number of urinary tract infection episodes during prophylaxis
timeFrame: 3 months
Secondary outcomes:
measure: improving the patient's quality of life
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: University Of Perugia
name: Elisabetta Costantini
role: STUDY_CHAIR
References:
Clinical trial NCT06057337: Families With Pride ("Familias Con Orgullo").
Official title: Promoting Health and Reducing Risk Among Hispanic Sexual Minority Youth and Their Families
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Drug Use
Keywords: randomized controlled trial
Hispanic sexual minority youth
parent-centered
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-09-28
Enrollment: 306
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the effects of a parenting intervention for Hispanic sexual minority youth in preventing/reducing drug use and depressive symptoms. It will also examine whether the intervention improves parent social support for the adolescent, parent acceptance, family functioning, and whether it reduces general stress and stress associated with being a Hispanic sexual minority.


Eligibility criteria: Inclusion Criteria:

* Youth, 13 - 19, who report at least one of the following: a) identify as gay, lesbian, or bisexual, or b) reports same-sex sexual behavior.
* Adolescent has their disclosed their sexual minority status to at least one parent.
* Adolescent is of Hispanic immigrant origin, defined by having at least one parent that self-identifies as Hispanic (English and Spanish speaking Hispanics can participate in the study).
* Adolescent lives with an adult parent who is willing to participate.
* Family lives in South Florida

Exclusion Criteria:

* Adolescent identifies as transgender.
* Family plans to move out of South Florida during the study period

Primary outcomes:
measure: Change in depression symptoms
timeFrame: Baseline up to 30 months
measure: Change in frequency of drug use
timeFrame: Baseline up to 30 months
measure: Change in quantity of drug use
timeFrame: Baseline up to 30 months
Secondary outcomes:
measure: Change in unprotected sexual behavior
timeFrame: Baseline up to 30 months
measure: Change in Family Functioning as assessed by the Parenting Practices Questionnaire
timeFrame: Baseline up to 30 months
measure: Change in Family Functioning as assessed by the Parent-Adolescent Communication Scale
timeFrame: Baseline up to 30 months
measure: Changes in Adolescent Stress as assessed by the Perceived Stress Scale
timeFrame: Baseline up to 30 months
measure: Changes in Parent Acceptance of Adolescents Sexual Orientation as assessed by the Perceived Parental Reactions Scale
timeFrame: Baseline up to 30 months
measure: Changes in Sexual Minority Stress as assessed by the Sexual Minority Adolescent Stress Scale
timeFrame: Baseline up to 30 months
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Guillermo Prado, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00291837: CT-2106 for the Second Line Treatment of Ovarian Cancer
Official title: Phase II Open Label Study of CT-2106 as a Single Agent in Patients With Advanced Metastatic Ovarian Cancer Who Have Failed One Prior Platinum and Taxane Based Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: ovarian
CT-2106
Lead sponsor: CTI BioPharma
Sponsor class: INDUSTRY
First posted: 2006-02-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this sudy is to determine the response rate of CT-2106 in patients with advanced ovarian cancer who have failed one prior platinum and taxane based regimen.


Eligibility criteria: Inclusion Criteria:

* Patients with advanced ovarian carcinoma, who have failed one prior platinum and taxane containing regimen
* Only one prior chemotherapy containing either cisplatin or carboplatin plus taxanes administered concomitantly
* At least one measurable lesion according to RECIST
* ECOG performance status 0 or 1
* at least 18 years old
* Adequate haematological function
* Adequate renal and hepatic functions
* Normal coagulation parameters

Exclusion Criteria:

* Platinum-sensitive patients (Group 2) who responded (CR or PR) to a 1st line therapy and subsequently progressed or relapsed after a treatment-free interval of \> 12 months
* Pregnant or lactating patients
* Prior treatment with camptothecins
* Presence or history of CNS metastasis or carcinomatous leptomeningitis;
* Current active infection per investigator assessment;
* Unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis;
* Current history of chronic diarrhea \>= grade 1 (CTCAE version 3);
* Surgery or radiotherapy ≤ 4 weeks before first study treatment. In case of cytoreductive surgery for the progression of the disease, ≤ 2 weeks before the 1st study treatment are allowed;
* Other uncontrolled, serious illness or medical condition, as determined by the investigator;
* Concomitant (or within 4 weeks before inclusion) administration of any other experimental drug under investigation;
* Concurrent treatment with any other anti-cancer therapy;
* Known HIV positivity or AIDS-related illness;
* Patients who cannot be regularly followed up for psychological, social, familial or geographic reasons.

Primary outcomes:
measure: response rate
Secondary outcomes:
measure: toxicity
measure: response duration
measure: time to progression
measure: survival
Other outcomes:
Locations:
city: Lyon
country: France
city: Saint Brieuc
country: France
city: Campobasso
country: Italy
city: Birmingham
country: United Kingdom
city: London
country: United Kingdom
city: Newcastle upon Tyne
country: United Kingdom
city: Surrey
country: United Kingdom
Study officials:
affiliation: Newcastle General Hospital
name: Hilary Calvert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02756637: Neutrophil-to-Lymphocyte Ratio in Bladder Cancer: A Secondary Biomarker Analysis of SWOG 8710
Official title: Neutrophil-to-Lymphocyte Ratio in Bladder Cancer: A Secondary Biomarker Analysis of SWOG 8710
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 634
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects enrolled in SWOG 8710

Brief summary: The purpose of this study is to perform a secondary analysis of SWOG 8710 to assess NLRs value as a biomarker. Specifically, the investigators test two hypotheses: 1) that baseline NLR is correlated with overall survival after curative treatment for BC and 2) that baseline NLR is correlated with the survival benefit of NAC. The study will look at the data from participants of the SWOG 8710 study.


Eligibility criteria: Inclusion Criteria:

1. SWOG 8710 original trial inclusion criteria included:

   * Node-negative, muscle-invasive transitional cell carcinoma of the bladder, T2-T4aN0M0 per the AJCC 4th edition staging manual.
   * SWOG performance status of 0 or 1
   * Adequate organ function by lab criteria (WBC \> 4,000 cells/mm3, platelets \>150,000 cells/mm3, creatinine \<1.5 md/dL (men) or \<1.3 md/dL (women), baseline liver tests \< 2 times normal limits)
2. Inclusion criteria for this secondary analysis are:

   * Eligible for original SWOG 8710 trial
   * Had complete blood count with differential prior to first treatment (radical cystectomy or NAC).

Exclusion Criteria:

1. SWOG 8710 original trial exclusion criteria included:

   * No age restrictions
   * Previous or concomitant malignancy other than bladder cancer or basal cell skin cancer
   * Prior pelvic radiation
   * Metastatic or incurable disease
   * Laboratory values exceeding those detailed in 3.1.c
2. Exclusion criteria for this secondary analysis are:

   * Ineligibility for the original SWOG 8710 study
   * Lack of complete blood count with differential prior to first treatment (cystectomy or NAC).

Primary outcomes:
measure: Overall Survival
timeFrame: 26 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: John Christodouleas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05023837: Efficacy and Safety of Immunotherapy in Non-small Cell Lung Cancer With Uncommon Histological Type
Official title: Evaluation of the Efficacy of Immunotherapy in Uncommon Pathological Types of Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uncommon Pathological Types of Lung Cancer
Keywords: Uncommon pathological types of lung cancer
Immune checkpoint inhibitor
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Advanced uncommon pathological types of lung cancer by histopathology

Brief summary: This study was designed to explore the efficacy and safety of immune checkpoint inhibitor for advanced uncommon pathological types of lung cancer whether or not it is accompanied by a driver mutationin the real world. Through retrospective collection of clinical data of patients with uncommon pathological types of lung cancer.The patients who are treated with immunosuppressive agents are screened out, and they are divided into immune combination therapy or immune monotherapy, and further evaluate whether there is a difference in efficacy between the two.

Detailed description: This is a research project involving patients in Medical Oncology Department of Affiliated Cancer Hospital of Xiangya School of Medicine Central South University. Retrospective study of 40 patients with advanced uncommon pathological types of lung cancer and observe the efficacy and safety of immune checkpoint inhibitor regimen in the real world. The patients who are treated with immunosuppressive agents are screened out, and they are divided into immune combination therapy or immune monotherapy, and further evaluate whether there is a difference in efficacy between the two. Statistical analysis is used to compare the differences between the two treatments, so that patients can better choose treatment strategies.

Eligibility criteria: Inclusion Criteria:

* 18，Advanced uncommon pathological types of lung cancer by histopathology whether or not it is accompanied by a driver mutation Treatment Plan is pembrolizumab 200mg iv q21d

Exclusion Criteria:

- Patients received antitumor treatment before Patients with contraindication of chemotherapy Pregnant or breast feeding women

Primary outcomes:
measure: PFS
timeFrame: may 2019- may 2021
Secondary outcomes:
measure: OS
timeFrame: may 2019- may 2021
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
Study officials:
affiliation: Hunan Cancer Hospital
name: Yongchang Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01889537: Low Dose Ketamine VR Analgesia During Burn Care Procedure
Official title: Low Dose Ketamine to Enhance VR Analgesia During Painful Burn Care Procedure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Burn
Keywords: Virtual Reality Ketamine
Lead sponsor: National Institute of General Medical Sciences (NIGMS)
Sponsor class: NIH
First posted: 2013-06-28
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the research is to see whether a low dose of ketamine, a medication used to reduce pain, enhances the effectiveness of a virtual reality video game, which is used as a form of distraction from pain during a painful burn care procedure.

Detailed description: This study is conducted in a hospital setting. It is a randomized controlled trial comparing the use of virtual reality distraction (VRD) and standard pain medications to the use of VRD, standard pain medications and a single low dose of ketamine as a means to reduce pain during a painful procedure in patients in the hospital.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years
* Compliant and able to complete questionnaires
* No history of psychiatric disorder
* Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
* Able to communicate verbally
* English-speaking
* IV access already in place

Exclusion Criteria:

* Age less than 18 years
* Not capable of indicating pain intensity
* Not capable of filling out study measures
* Evidence of traumatic brain injury
* History of psychiatric disorder
* Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems
* Unable to communicate orally
* Receiving prophylaxis for alcohol or drug withdrawal
* Developmental disability
* Any face/head/neck injuries that interfere with the use of Virtual Reality equipment
* Non-English Speaking
* Extreme susceptibility to motion sickness
* Seizure history
* No IV access already in place

Primary outcomes:
measure: Graphic Rating Scale (GRS) is a questionnaire consists of three subjective pain ratings, one subjective anxiety rating, and one rating of fun using the 0-10.
timeFrame: 1 day (Immediately following burn care )
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: David R Patterson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02018237: High Fructose Corn Syrup
Official title: The Effect of High Fructose Corn Syrup Feeding in Nonalcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonalcoholic Fatty Liver Disease
Obesity
Keywords: Obesity
Nonalcoholic fatty liver disease
High fructose corn syrup
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research study is to learn more about how high fructose corn syrup, a sugar used to sweeten drinks and foods, affects metabolism in obese persons with and without nonalcoholic fatty liver disease. Eligible participants will be studied before and after eating a diet high in high fructose corn syrup or a standard diet (low in high fructose corn syrup) for four weeks.


Eligibility criteria: Inclusion Criteria:

* IHTG \>6.5% or \<5%
* BMI 30.0-45.0 kg/m²
* Sedentary
* Consume \<10% calories from high fructose corn syrup
* Weight stable for previous 3 months

Exclusion Criteria:

* IHTG 5.1-7.9%
* Children
* Adults over 65 years
* Pregnant
* Lactating
* Exercise \>1.5 hours/week
* Hepatitis B or C
* Diabetes
* History of liver disease
* History of alcohol abuse
* Severe hypertriglyceridemia (\>300 mg/dl)
* Smokers
* Anemia (Hemoglobin \<10mg/dl)
* Not weight stable

Primary outcomes:
measure: Change in intrahepatic triglyceride (IHTG) content
timeFrame: 4 weeks
measure: Hepatic lipid metabolism
timeFrame: 4 weeks
measure: Multi-organ insulin sensitivity
timeFrame: 4 weeks
measure: Uric acid metabolism
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Associate Professor of Medicine
name: Shelby A Sullivan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Medicine
name: Samuel Klein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03580837: Breast MRI for Neaodjuvant Chemotherapy Response Prediction and Evaluation in Breast Cancer
Official title: Breast MRI for Neaodjuvant Chemotherapy Response Prediction and Evaluation in Breast Cancer, With Focus on Background Parenchymal Enhancement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Breast Cancer
Neoadjuvant chemotherapy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast cancer treated with neoadjuvant chemotherapy

Brief summary: The aim of this retrospective study is to evaluate the value of pre-treatment and post-treatment multimodality MRI study, including quantitative evaluation of background parenchymal enhancement, for response prediction and evaluation. This study will include 100 patients treated in a single institution between 2011 and 2016


Eligibility criteria: Inclusion Criteria:

* Adult patients
* Patients with breast cancer treated with neoadjuvant chemotherapy
* Patients with pre- and post-chemotherapy MRI
* Patients who have given their agreement to use their data for research purposes.

Exclusion Criteria:

- Refusal to participate in the study

Primary outcomes:
measure: Presence or absence of of pathologic enhancement of breast by MRI
timeFrame: 1 hour after the realization of the MRI
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Imagerie 1
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Sébastien MOLIERE, MD
role: PRINCIPAL_INVESTIGATOR
References: