louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00596544: Sexual Functioning After Primary Treatment of Ovarian Cancer
Official title: Sexual Functioning After Primary Treatment of Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ovarian Cancer
Sexual Dysfunction
Keywords: sexual dysfunction
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-01-17
Enrollment: 18
Sex: FEMALE
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: MSKCC clinic

Brief summary: The purpose of this study is to help us learn more about sexual problems after treatment for ovarian cancer. At this time, we do not know how many women have sexual problems after they are treated for ovarian cancer.

How common are sexual problems after treatment for ovarian cancer?

* What factors make women more likely to have sexual problems after treatment for ovarian cancer?
* What happens to sexual functioning over the first 12 months after treatment? ie.

Does it get better or worse?

• Does referral to a specialized sexual health clinic help?


Eligibility criteria: Inclusion Criteria:

* Women with any stage of invasive epithelial ovarian cancer who have completed frontline therapy within the past 6 months
* Women must have no clinical evidence of disease
* At least 18 years of age
* English speaking
* Able to participate in the informed consent process
* Women who present to Sexual Health Clinic for the first time and meet all other eligibility criteria are eligible. Their FSFI scores will be used to determine the primary endpoint of prevalence of sexual dysfunction. If they score over 26 on the FSFI, they may still elect to be followed at the SHC.

Exclusion Criteria:

* Active secondary cancer requiring cytotoxic chemotherapy at the time enrollment
* Evidence of recurrent/persistent disease by elevated CA125, findings on imaging (CT, PET scan etc) or physical examination
* Women with borderline (low malignant potential) ovarian cancers
* Women who are already in active evaluation and/or follow-up at the Sexual Health Clinic
* Women with a history of prior whole pelvic radiation

Primary outcomes:
measure: To estimate the prevalence of sexual dysfunction, as measured by Female Sexual Functioning Index (FSFI) among women who have completed first-line treatment for ovarian cancer within the last 6 months and currently have no evidence of disease.
timeFrame: conclusion of study
Secondary outcomes:
measure: To study the natural history of sexual functioning in women after primary treatment of ovarian cancer by using the FSFI at approximately 3, 6 and 12 months.
timeFrame: conclusion of study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Elizabeth Jewell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01523444: Advancing Adolescent Screening and Brief Intervention Protocols in Primary Care Settings
Official title: Advancing Adolescent Screening and Brief Intervention Protocols in Primary Care Settings
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Substance Abuse
Keywords: Adolescents
Screening
Advice
Referral
Lead sponsor: Public Health Management Corporation
Sponsor class: OTHER
First posted: 2012-02-01
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This proposed study tests the effectiveness and examines the implementation of screening and brief intervention techniques to delay initiation and reduce substance use among adolescents accessing medical care in Federally Qualified Health Care settings with a computer-facilitated intervention. The primary hypothesis is that participants in the intervention groups will be more likely to cease or reduce substance use at follow-up compared to clients in the treatment as usual condition.

Detailed description: The aims of the proposed 5-year study are threefold: (1) To examine the effectiveness of a computer-facilitated Screening and Brief Advice (cSBA) to reduce initiation and substance abuse among adolescents in a novel setting; (2) To examine the comparative effectiveness of adding a Brief Intervention and Referral to Treatment component to the cSBA intervention among adolescents in these centers; (3) To examine factors facilitating and inhibiting the implementation of SBIRT-type procedures with adolescents in FQHCs.

Eligibility criteria: Inclusion Criteria:

* 12-18 year old patients seeking care at the primary care participating sites

Exclusion Criteria:

* Unable to read and understand English
* Medically unstable
* Unavailable for follow-up

Primary outcomes:
measure: Reduced substance use
timeFrame: 3 and 12 months
Secondary outcomes:
measure: Initiation of substance use
timeFrame: 3 and 12 Months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Treatment Research Institute
state: Pennsylvania
Study officials:
affiliation: Treatment Research Institute
name: Amy Mericle, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04573244: Hemoglobin Easy Measurement With Optical Artificial Intelligence
Official title: A Prospective Feasibility Study to Explore the Utility of Using a Smartphone Camera to Monitor Blood Hemoglobin Levels in Children and Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemoglobin; Deficiency
Lead sponsor: MYOR Ltd.
Sponsor class: INDUSTRY
First posted: 2020-10-05
Enrollment: 823
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients admitted to the Pediatric Department, Pediatric Emergency Department (PED) or Pediatric Hematology Unit (PHU) who have undergone a CBC

Brief summary: Blood hemoglobin levels are an extremely important measure for a large swath of medical procedures as they reflect the oxygen-carrying capacity of human blood. The gold standard measure for blood hemoglobin levels involve a venous blood draw followed by a laboratory-based complete blood count (CBC), a process which is both painful and time consuming. To date, various methodologies have been tested to either expediate the process or provide a non-invasive alternative. There remains a need to provide a quick, pain-free/non-invasive and accurate modality to measure blood hemoglobin levels. The objective of this study is to determine whether computer vision technologies can be applied to fingernail images captured via a smartphone camera to quantify blood hemoglobin levels.


Eligibility criteria: Inclusion Criteria:

1. A patient aged 6 months to 18 years.
2. A patient who has undergone a venous blood draw for a CBC since being admitted to the PED no more than 6 hours prior to study enrollment.
3. Parents or legal guardian provide informed written consent.

Exclusion Criteria:

1. Patient has subungual hematoma, nail bed lacerations or avulsion injuries on both hands.
2. Patient has total leukonychia.
3. Patient has nail polish applied on fingernails.
4. Patient has nailbed darkening or discoloration due to medication.
5. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety.

Primary outcomes:
measure: To determine whether computational learning methods can be applied to fingernail images captured via a smartphone camera to quantify blood hemoglobin levels.
timeFrame: 6 months
Secondary outcomes:
measure: To determine whether computational learning methods can be applied to fingernail images captured via a smartphone camera to screen for anemia as defined by the WHO
timeFrame: 6 months
measure: To determine whether computational learning methods can be applied to fingernail images captured via a smartphone camera to quantify other elements of the CBC
timeFrame: 6 months
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Emek Medical Center
Study officials:
affiliation: Emek Medical Center
name: Gilad Moshe Chayen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02524444: A Comparative Study of Mefloquine and S-P as Prophylaxis Against Malaria in Pregnant HIV + Patients
Official title: A Comparative Study of Mefloquine and Sulphadoxine-pyrimethamine as Prophylaxis Against Malaria in Pregnant Human Immunodeficiency Virus Positive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malaria in Pregnant HIV + Patients
Keywords: Intermittent preventive therapy
malaria
pregnant
HIV positive
Prevention
Lead sponsor: University of Ibadan
Sponsor class: OTHER
Collaborators: name: University of Ibadan
First posted: 2015-08-14
Enrollment: 142
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: Randomized controlled single blind prospective comparative study.

Detailed description: This study is intended to be a randomized controlled single blind prospective comparative study conducted to compare the efficacy of three, monthly doses of sulphadoxine-pyrimethamine as intermittent preventive therapy with Mefloquine as-intermittent preventive therapy in HIV-infected pregnant women.

Eligibility criteria: Inclusion Criteria:

* Pregnant HIV positive patients
* Gestational age 16 weeks and above
* No history of use of Mefloquine or Sulphadoxine
* Pyrimethamine four weeks prior to recruitment.

Exclusion Criteria:

* Anaemia packed cell volume less than 30%
* Pre -existing medical conditions- Diabetes Mellitus, -Hypertension
* Allergy to Sulphadoxine- Pyrimethamine or Mefloquine
* Non-consenting patients
* Multiple gestation
* Known psychiatric illness
* Known seizure disorder
* History of severe renal or hepatic disease

Primary outcomes:
measure: Level of malaria parasitemia in HIV positive women at delivery after administration of Mefloquine or sulphadoxine-pyrimethamine as prophylaxis for malaria in pregnancy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ibadan
country: Nigeria
facility: University College Hospital
state: OYO State
Study officials:
affiliation: UNIVERSITY COLLEGE HOSPITAL,IBADAN,OYO STATE, NIGERIA
name: AYODELE O AROWOJOLU, MBBS IBADAN
role: STUDY_DIRECTOR
affiliation: UNIVERSITY COLLEGE HOSPITAL,IBADAN,OYO STATE,NIGERIA
name: ORIYOMI O AKINYOTU, MBBS IBADAN
role: PRINCIPAL_INVESTIGATOR
affiliation: UNIVERSITY COLLEGE HOSPITAL,IBADAN,OYO STATE, NIGERIA
name: ADENIKE F BELLO, MBBS IBADAN
role: STUDY_DIRECTOR
References:
citation: Steketee RW, Wirima JJ, Slutsker L, Khoromana CO, Heymann DL, Breman JG. Malaria treatment and prevention in pregnancy: indications for use and adverse events associated with use of chloroquine or mefloquine. Am J Trop Med Hyg. 1996;55(1 Suppl):50-6. doi: 10.4269/ajtmh.1996.55.50.
citation: Akinyotu O, Bello F, Abdus-Salam R, Arowojolu A. Comparative study of mefloquine and sulphadoxine-pyrimethamine for malaria prevention among pregnant women with HIV in southwest Nigeria. Int J Gynaecol Obstet. 2018 Aug;142(2):194-200. doi: 10.1002/ijgo.12516. Epub 2018 May 25.
Clinical trial NCT01198444: To Evaluate Compliance to Treatment Regimen (Rate of Deviations From the Prescribed Regimen) in Polish Females Treated With Different Low Dose Oral Contraceptives
Official title: Prospective, Open-label Observational Survey Evaluating Patients Compliance to Administration Regimen During Low Dose Combined Oral Contraceptive Use in Everyday Praxis Data on Oral Contraceptives Compliance - DOC Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Keywords: Contraception
Compliance
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-09-10
Enrollment: 11884
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Gynecological practices patients - starters or current users.

Brief summary: Adherence to the dosing scheme is the principal element of Combined Oral Contraceptives efficiency. On the other hand noncompliance seemed to be an inseparable element of any oral treatment. The aim of the study is to evaluate in everyday practice the relation between dosage errors and indicated factors, potentially influencing the compliance with the dosing scheme.


Eligibility criteria: Inclusion Criteria:

* Patients at the age of over 18 requiring contraception. The decisions would be made at the discretion of the attending physician.

Exclusion Criteria:

* According to official Summary of Product Characteristics (SmPC) contraindications.

Primary outcomes:
measure: The percentage of users showing noncompliant behaviors
timeFrame: 3 consecutive cycles
Secondary outcomes:
measure: The characteristics of noncompliant behavior
timeFrame: 3 consecutive cycles
measure: The relation between noncompliant behavior and selected factors
timeFrame: 3 consecutive cycles
Other outcomes:
Locations:
city: Many Locations
country: Poland
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01571544: The Use of Thermal Suits as Preventing Hypothermia During Surgery
Official title: The Use of Thermal Suits as Preventing Hypothermia During Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2012-04-05
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Unintentional hypothermia of a patient is a common adverse effect during surgical procedures. The aim of this prospective, randomised, controlled study is to determine whether the use of thermal suit could prevent surgical patient from experiencing thermal loss than conventional measures.

Hypothesis: The investigators assume that a difference of 0.5°C in body temperature between the groups is clinically relevant.

Detailed description: The aim of this study was to compare a thermal suit (T-Balance) and conventional warming methods to maintain a constant body temperature in patients undergoing robotic laparoscopic radical prostatectomy under general anesthesia.

A sample size calculation was made using a power analysis. Patients were randomly allocated into two groups.

Patients in the intervention group were put on the T-Balance 1 hour before anesthesia induction. Patients in the control group got conventional cotton clothes. Intra-operatively same warming methods were used in both groups. The measuring points of the temperature were esophagus (core temperature), left axilla, dorsal surface of the left middle finger and back of the left foot.

Anesthesia was induced via target-controlled infusion. All temperature data of the patients were collected and recorded electrically and continuously.

Eligibility criteria: Inclusion Criteria:

* radical prostatectomy, American Society of Anaesthesiologists class I-III, age 18-90

Exclusion Criteria:

* mental status with inability to give informed consent, neuromuscular disorders, Raynaud's disease, unstable angina pectoris

Primary outcomes:
measure: Temperature
timeFrame: from one hour before surgery up to the ward after surgery, estimated 10 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Sirkka-Liisa Lauronen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00177944: Invasive Fungal Infections Surveillance Initiative
Official title: Invasive Fungal Infections Surveillance Initiative
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fungal Infection
Keywords: invasive fungal infection
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2005-09-15
Enrollment: 172
Sex: ALL
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: patients with funal infections

Brief summary: The purpose of this study is to optimize the management of patients treated for invasive fungal infections by establishing a real-time, continuous clinical data base that will capture and monitor trends in the epidemiology, diagnosis, treatment and outcomes of invasive fungal infections; reflect routine clinical management of patients with invasive fungal infections in order to evaluate treatment and provide a rationale for future treatment paradigms; and allow physicians to assess adherence to institutional clinical practice guidelines, validate current standardized definitions for patients with invasive fungal infections and promote change where appropriate.

Detailed description: Gender, height, weight, ethnicity, antifungal treatment, fungal colonization, laboratory results, past medical history, invasive fungal infection diagnosis, medications, outcomes

Eligibility criteria: Inclusion Criteria:

* All patients with a diagnosis of proven or probable invasive fungal infection . This includes patients with proven or probable invasive mold infections as well as patients with proven candidemia.

Exclusion Criteria:

* All patients with a diagnosis of possible invasive fungal infection . This includes patients with possible mold infections as well as patients with possible candidemia.

Primary outcomes:
measure: outcome after invasive fungal infection
timeFrame: 60 days post infection
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Fernanda Silveira, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02135744: Pre-Discharge Bundle for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease to Reduce Readmissions
Official title: Pre-Discharge Bundle for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease to Reduce Readmissions and Emergency Department Visits: a Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Exacerbation of Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
COPD
Readmissions
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2014-05-12
Enrollment: 172
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hospital readmissions for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) pose burdens to the healthcare system and patients. The aim of this study was to determine whether a screening and educational tool, administered prior to discharge, would result in a decrease in the rate of hospital readmissions.

Detailed description: Hospital readmissions for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) pose burdens to the healthcare system and patients. A current gap in knowledge is whether a pre-discharge screening and educational tool, administered to patients with COPD, reduces readmissions and emergency department (ED) visits.

A single center, randomized trial of patients admitted with AECOPD. Patients will be randomized to control (standard care) or "bundle" group in which patients receive smoking cessation counseling, screening for gastroesophageal reflux disease and depression or anxiety, standardized inhaler teaching, and a 48-hour post-discharge phone call.

Eligibility criteria: Inclusion Criteria:

* diagnosis of COPD with the presence of an AECOPD
* Age \> 40
* Current or ex-smoker with history of at least 20 pack-years

Exclusion Criteria:

* Past history of asthma, interstitial lung disease, bronchiectasis, presence of airway hardware (e.g. tracheal stents or tracheotomy), lung cancer, any other cancer with a life expectancy of less than 1 year
* Presence of a language barrier
* Residence in a nursing home
* Intensive care unit stay during the current admission
* Delirium or dementia.

Primary outcomes:
measure: 30 day readmission rate
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
References:
citation: Jennings JH, Thavarajah K, Mendez MP, Eichenhorn M, Kvale P, Yessayan L. Predischarge bundle for patients with acute exacerbations of COPD to reduce readmissions and ED visits: a randomized controlled trial. Chest. 2015 May;147(5):1227-1234. doi: 10.1378/chest.14-1123.
Clinical trial NCT02923544: Trial of YUMI Uterine Manipulator
Official title: Pilot Trial of YUMI Uterine Manipulator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Condition
Scheduled for a Total Laparoscopic or Robotic-assisted Hysterectomy
Keywords: Uterine Manipulator
Yukio's Uterine Manipulating Instrument (YUMI)
16-1397
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the feasibility and safety of using a new device called Yukio's Uterine Manipulating Instrument (YUMI). The YUMI is a type of uterine manipulator. It is a reusable metal device designed to be simple and study. It is also adjustable in size which makes it easy for surgeons to use. It will be placed at the beginning of the surgery and removed at the end. This study will allow the researchers to find out if the surgeons find the YUMI effective and easy to use. It will also allow the researchers to see if the device is safe. This is the first time that the YUMI is being used in humans.


Eligibility criteria: Inclusion Criteria:

* Participant must be scheduled for a total laparoscopic or robotic-assisted hysterectomy for a gynecologic condition
* Participants must be 18 years of age or older

Exclusion Criteria:

* Participant is not eligible if the surgeon does not plan to use a uterine manipulator

Primary outcomes:
measure: number of successfully placed Uterine Manipulator
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up only)
state: New Jersey
city: Middletown
country: United States
facility: Memoral Sloan Kettering Monmouth (Consent and Follow-Up only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent and Follow-Up only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent and Follow-Up only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent and Follow-Up only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent and Follow-Up only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Yukio Sonoda, MD
role: PRINCIPAL_INVESTIGATOR
References: