louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02606110: Pilot Study Investigating the Use of the ReBuilder to Treat Chemotherapy Induced Peripheral Neuropathy in Patients With Breast Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Peripheral Neuropathy
Keywords: ReBuilder
breast cancer
chemotherapy induced
Lead sponsor: Eastern Regional Medical Center
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast cancer and chemotherapy induced peripheral neuropathy

Brief summary: The purpose of this study is to investigate the effect of the ReBuilder in the treatment of individuals with breast cancer and chemotherapy induced peripheral neuropathy.


Eligibility criteria: Inclusion Criteria:

* Patients with breast cancer referred to Physical Therapy for CIPN
* Physical Therapy Examination indicates use of Rebuilder for CIPN
* At least 18 years of age
* Signed informed consent for study population
* Willingness to complete study according to protocol

Exclusion Criteria:

* Patients who do not have CIPN
* Patients \<18 years of age
* Inability to or unwilling to sign informed consent
* Unable to read and understand the English language
* Preexisting sensory peripheral neuropathy from other comorbid conditions such as diabetes or alcoholism
* More than three (3) prior ReBuilder treatments; OR ReBuilder within the last 30 days, for sensory peripheral neuropathy

Primary outcomes:
measure: Changes in touch and sensory by way of change in the Semmes-Weinstein Monofilament Testing
timeFrame: one year
measure: Changes in touch and sensory by way of changes in Functional Gait Assessment
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Eastern Regional Medical Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04453410: Validation of a Pediatric Pictorial Version of the QOR-15 Postoperatory Functional Recovery Scale - QoR-15 Pédiatric
Official title: Validation of a Pediatric Pictorial Version of the QOR-15 Postoperatory Functional Recovery Scale - QoR-15 Pédiatric
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Intervention
Minor
Keywords: questionnaire Quality-of-recovery 15 (QoR-15)
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 153
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minor patient over 7 years and up to 17 years and 9 months who have a programming surgery as part of routine management

Brief summary: Consideration from the patient's point of view is an important step in improving postoperative functional recovery. The questionnaire Quality-of-recovery 15 (QoR-15) is a psychometrically validated questionnaire to measure the quality of postoperative functional recovery. it has been recommended in perioperative medecine however, this questionnaire was never adapted and validated for a pediatric surgical population.

The main objective of this protocol is to study the validity, reliability, acceptability and feasibility in routine clinical practice of a pediatric pictorial version of the QoR-15 score.


Eligibility criteria: Inclusion Criteria:

* Patient underage over 7 years and up to 17 years and 9 months
* Programming surgery as part of routine management
* Patient affiliated with a health insurance social
* Parental authority holders and the patient agreeing to participate in the study

Exclusion Criteria:

* Patients with severe sensory impairment in preoperation preventing reliable participation in the questionnaire
* Patients at risk of severe cognitive or sensory impairment in postoperative
* Patients with language difficulties in the language of administration of the questionnaire
* Patients who can not express their non-opposition to participation in the study
* Refusal of holders of parental authority and/or refusal of the patient to participate in the study

Primary outcomes:
measure: Questionnaire Quality-of-recovery 15 score
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT00015210: Nefazodone in the Treatment of Cocaine Dependence and Depression - 4
Official title: Efficacy of Nefazodone in Cocaine Dependent Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Substance-Related Disorders
Keywords: Cocaine Use Disorders Dependence Depression
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Boston University
First posted: 2001-04-18
Enrollment: 69
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is the use of Nefazodone in the treatment of cocaine dependence and depression comorbidity.

Detailed description: The objective of this study is to determine the safety and efficacy of nefazodone (Serzone ) in depressed cocaine dependent subjects. This is a hypothesis-testing study which will explore whether cocaine usage will be reduced in the nefazodone treatment group compared to a placebo control group.

Eligibility criteria: Inclusion Criteria:

DSM-IV diagnosis of cocaine dependence, Depression score of 12 or above and history of depression. Males and non-pregnant, non-nursing females 21-55 years of age.

Exclusion Criteria:

Axis I diagnosis other than substance use disorder, major depression, anxiety of dysthymic disorder. Physiological dependence on alcohol. Significant medical or neurological history. Abnormal UA, CBC or Chem 23 (LFT's may be up to 3 times normal). Enrollment in an opiate-substitution treatment program within 45 days of enrollment in the present study.

Primary outcomes:
measure: Urine benzoylecgonine (BE) concentration
timeFrame: Study Weeks Basekine to Week 8
Secondary outcomes:
measure: Hamilton Depression Scale (HAM-D)
timeFrame: Baseline through Study Week 8
measure: Cocaine-Craving Scale
timeFrame: Baseline through Week 8
measure: Adverse Events Self Report
timeFrame: Study Weeks 1 through 8
measure: Alcohol Drug Use Inventory
timeFrame: Baseline through Study Week 8
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: Boston University
name: Dom Ciraulo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ciraulo DA, Knapp C, Rotrosen J, Sarid-Segal O, Ciraulo AM, LoCastro J, Greenblatt DJ, Leiderman D. Nefazodone treatment of cocaine dependence with comorbid depressive symptoms. Addiction. 2005 Mar;100 Suppl 1:23-31. doi: 10.1111/j.1360-0443.2005.00984.x.
Clinical trial NCT03483610: Promoting Cervical Cancer Screening for Emergency Department Patients
Official title: Piloting Interventions to Improve Adherence to Cervical Cancer Screening Recommendations Among Emergency Department Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2018-03-30
Enrollment: 95
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to learn methods to encourage women to get recommended cervical cancer screening. Cervical cancer screening is an important part of cervical cancer prevention. The study team will determine if the patient is currently up-to-date with cervical cancer screening recommendations. If the patient is not up-to-date, then they will be randomly assigned to one of two interventions. One intervention consists only of referral to a women's health care provider to obtain cervical cancer screening. The other intervention consists of receiving a total of 3 text messages at 30-day intervals encouraging follow-up for cervical cancer screening.


Eligibility criteria: Inclusion Criteria:

* Registered patient in the Emergency Department of the University of Rochester Medical Center
* Women
* Age 21 - 65

Exclusion Criteria:

* Past hysterectomy with cervical removal
* Known infection with HIV (screening recommendations for women with HIV differ from the general population)
* Non-English speaking
* Inability to consent
* Lack of text-capable mobile phone and/or inability to use text function

Primary outcomes:
measure: Number of Participants Who Scheduled or Completed Cervical Cancer Screening
timeFrame: 150 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester, Department of Emergency Medicine
state: New York
Study officials:
References:
Clinical trial NCT01191710: Progesterone Rise in Agonist Versus Antagonist in Vitro Fertilization (IVF) Cycles
Official title: Is the Clinical Outcome Affected by the Incidence of Progesterone Elevation on the Day of hCG Triggering When Agonist Protocol is Compared to Antagonist Protocol for IVF
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pregnancy Outcome After In Vitro Fertilization (IVF)
Keywords: progesterone
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: BioGenesis
First posted: 2010-08-31
Enrollment: 200
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to explore whether the incidence of progesterone rise in the late follicular phase differs between GnRH-agonist and GnRH-antagonist protocols for IVF and whether this has an impact on the probability of pregnancy achievement.

Detailed description: In view of the current debate concerning possible differences in efficacy between the two GnRH analogues, the current study aimed to explore whether progesterone control in the late follicular phase differs when GnRH-agonist is used as compared to GnRH-antagonist and if so to what extend does the progesterone rise have an impact on the probability of achieving a pregnancy.

Eligibility criteria: Inclusion Criteria:

* age \< 39
* follicle-stimulating hormone (FSH) \< 12
* gonadotropin dose 100-300IU

Exclusion Criteria:

* endometriosis
* known endocrine disorder
* blood analyzed in another laboratory

Primary outcomes:
measure: Incidence of late progesterone rise on the day of HCG triggering
timeFrame: Up to delivery (2010)
Secondary outcomes:
measure: Clinical pregnancy rate Delivery rate
timeFrame: Up to delivery (2010)
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Biogenesis
state: Pylaia
Study officials:
affiliation: BioGenesis
name: Basil Tarlatzis, MD
role: STUDY_CHAIR
References:
citation: Papanikolaou EG, Kolibianakis EM, Pozzobon C, Tank P, Tournaye H, Bourgain C, Van Steirteghem A, Devroey P. Progesterone rise on the day of human chorionic gonadotropin administration impairs pregnancy outcome in day 3 single-embryo transfer, while has no effect on day 5 single blastocyst transfer. Fertil Steril. 2009 Mar;91(3):949-52. doi: 10.1016/j.fertnstert.2006.12.064. Epub 2007 Jun 6.
citation: Papanikolaou EG, Pados G, Grimbizis G, Bili E, Kyriazi L, Polyzos NP, Humaidan P, Tournaye H, Tarlatzis B. GnRH-agonist versus GnRH-antagonist IVF cycles: is the reproductive outcome affected by the incidence of progesterone elevation on the day of HCG triggering? A randomized prospective study. Hum Reprod. 2012 Jun;27(6):1822-8. doi: 10.1093/humrep/des066. Epub 2012 Mar 14.
Clinical trial NCT00970710: Vaasa Childhood Obesity Primary Prevention Study
Official title: Vaasa Childhood Obesity Primary Prevention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity Pevention
Lead sponsor: Tampere University
Sponsor class: OTHER
Collaborators: name: Foundation for Paediatric Research, Finland
name: Vaasa Health care center
name: Seinajoki Central Hospital
name: Tampere University Hospital
First posted: 2009-09-02
Enrollment: 185
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pragmatic controlled trial
Primary purpose: PREVENTION

Brief summary: This study aims to prevent childhood obesity with early life (pregnancy) intensified counselling. The recruited intervention group is pregnant mothers who are at risk to get gestational diabetes. Lifestyle intervention (nutritional and physical activity) begins during pregnancy in maternity clinics and continues in child wellfare clinics until the child is 5 years of age.


Eligibility criteria: Inclusion Criteria:

* Pregnant women who are at risk to get gestational diabetes.

Exclusion Criteria:

* Foreigner with language problems
* Major psychosocial problems
* Diabetes mellitus type I or II
* Physical disability,
* Major medical problems in pregnancy

Primary outcomes:
measure: Preventing childhood obesity
timeFrame: Offspring age until six years
Secondary outcomes:
measure: lower cholesterol values
timeFrame: up to six years
measure: lower HOMA-index
timeFrame: up to six years
Other outcomes:
Locations:
city: Vaasa
country: Finland
facility: Health care center in Vaasa
Study officials:
affiliation: Seinajoki Central Hospital
name: Taina E. Mustila, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mustila T, Raitanen J, Keskinen P, Luoto R. A pragmatic controlled trial to prevent childhood obesity within a risk group at maternity and child health-care clinics: results up to six years of age (the VACOPP study). BMC Pediatr. 2018 Feb 27;18(1):89. doi: 10.1186/s12887-018-1065-3.
citation: Mustila T, Raitanen J, Keskinen P, Saari A, Luoto R. Pragmatic controlled trial to prevent childhood obesity in maternity and child health care clinics: pregnancy and infant weight outcomes (the VACOPP Study). BMC Pediatr. 2013 May 20;13:80. doi: 10.1186/1471-2431-13-80.
citation: Mustila T, Keskinen P, Luoto R. Behavioral counseling to prevent childhood obesity--study protocol of a pragmatic trial in maternity and child health care. BMC Pediatr. 2012 Jul 3;12:93. doi: 10.1186/1471-2431-12-93.
Clinical trial NCT00917410: Mobile Phone Text for Optimizing Asthma Treatment
Official title: Assessment of the Health Related Effects of Compliance Optimization in Asthma Through Use of SMS (Short Message System) - A Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: MedicoMonitor Aps
name: The Ministry of Health and Prevention, Denmark
First posted: 2009-06-10
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aims at providing information on how the Short Message Service (SMS) tool influences self-management in asthma patients and to assess the resulting health related effect. A wide range of models and theories exist in the compliance area, such as technical models, communication models, cognitive models and self-management models and theories. The use of some of these theories and models will serve as theoretical and explanatory tools for studying how and why the SMS tool influences the patient's self-management.

Objective:

The objective of this study is to assess the health-related effects of a SMS compliance and monitoring system for optimized asthma treatment in a controlled trial setting.


Eligibility criteria: Inclusion Criteria:

* asthmatics

Exclusion Criteria:

* below 18 and above 45
* COPD patients
* no mobile phone
* not using the prescribed asthma inhalation medication

Primary outcomes:
measure: Asthma control test
measure: EQ-5D
timeFrame: 0, 45, 90 days
measure: Use of health services
timeFrame: 0, 45, 90 days
measure: Use of preventive medicine
timeFrame: 0, 45, 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
Study officials:
affiliation: University of Copenhagen
name: Claus Møldrup, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04506710: Improvement of Communicational Skills Between Health Workers and Oncological Patients During Medical Consultative Conversations
Official title: Ways to Improve the Efficiency of Communication Between Health Workers and Oncological Patients During Medical Consultative Conversations: an Observational Clinical Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males with low-risk prostate cancer

Brief summary: The aim of the study is to identify the specific patterns of communication between doctors and oncological patients during medical consultations and develop recommendations to improve its effectiveness.


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed prostate cancer;
2. PSA up to 10 ng / ml; Gleason (3 + 3) = 6 (ISUP 1); the stage of the tumor T2a (low- risk according to the D'Amico scale);

Exclusion Criteria:

1. Failure of the recording device;
2. Unsatisfactory audio quality.

Primary outcomes:
measure: Identification the communication techniques used by the doctor in the counseling conversation;
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Institute for Urology and Reproductive Health, Sechenov University.
Study officials:
affiliation: Institute of Linguistics and Intercultural Communication
name: Fedorovskaya Viktorya
role: STUDY_DIRECTOR
References:
Clinical trial NCT03611010: Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients
Official title: Phase II, Dose-ranging Study to Evaluate the Efficacy Dose Response and Pharmacokinetics of Intravenous Atorvastatin in Hypercholesterolemic Patients Previously Controlled With Oral Atorvastatin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Dyslipidemias
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-08-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Open-label study will titrate doses of intravenous atorvastatin and monitor respective LDL-C levels in hypercholesterolemic patients previously controlled on oral atorvastatin.


Eligibility criteria: Inclusion Criteria:

* On stable dose of daily oral atorvastatin for \>= 5 weeks (oral atorvastatin may be provided during a lead-in period for subjects not previously taking atorvastatin)
* Stable LDL-C confirmed in the previous 7 to 10 days prior to enrollment into the treatment phase.

Exclusion Criteria:

* History of myopathy or rhabdomyolysis
* Liver disease including current biliary disorders
* Positive for HIV, Hepatitis B or Hepatitis C Virus
* Abuse of alcohol or non-prescribed drugs
* Unstable angina or arrhythmias or a cardiac event in the previous three months
* hypothyroidism, diabetes, or hypertension that is not under control
* pregnant or plans to be pregnant

Primary outcomes:
measure: Efficacy, Number of Participants With Day 15 LDL-C Less Than or Equal to 125% of Baseline LDL-C
timeFrame: Baseline, 15 Days
Secondary outcomes:
measure: Efficacy, Number of Participants With Day 15 HDL-C More Than or Equal to 75% Baseline HDL-C
timeFrame: Baseline, 15 Days
measure: Change in Baseline LDL-C Concentration
timeFrame: Baseline, 15 days
measure: Cmax IV
timeFrame: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose
measure: Tmax IV
timeFrame: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose
measure: AUC 0-24
timeFrame: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose
measure: AUC Inf
timeFrame: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose
measure: VDss
timeFrame: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose
measure: t 1/2
timeFrame: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose
Other outcomes:
Locations:
city: Secaucus
country: United States
facility: Frontage Clinical Services
state: New Jersey
Study officials:
affiliation: Frontage Lab
name: Gregory Tracey, MD
role: PRINCIPAL_INVESTIGATOR
References: