louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02144974: Reconstruction of the Pelvic Floor After Total Pelvic Exenteration Using the TMG Flap
Official title: Reconstruction of the Pelvic Floor and the Vagina After Total Pelvic Exenteration Using the Transverse Musculocutaneous Gracilis Flap
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reconstruction of the Pelvic Floor After Total Pelvic Exenteration.
Keywords: Total pelvic exenteration.
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2014-05-22
Enrollment: 12
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the department of Gynecology in the University hospital of Tampere, who underwent total pelvic exenteration with reconstruction of the pelvic floor (no:12)

Brief summary: Total pelvic exenteration (TPE) is a rare operation, which is the only possible curative intervention to treat central residual or recurrent tumors of the vulvar, vaginal, cervical, or uterine malignancies after initial surgery, radiation therapy and chemotherapy. Several options for pelvic floor and vaginal reconstruction have been described. The transverse musculocutaneous gracilis (TMG) flap has been introduced for breast reconstruction as a free flap. The investigators adopted the pedicled TMG flap for reconstruction after TPE.

Between November 2011 and February 2014, twelve patients underwent TPE and reconstruction with unilateral (6 patients) or bilateral (6 patients) pedicled TMG flaps. Five patients had vaginal reconstruction with bilateral TMG flaps. The investigators describe the operative procedure and the outcome of the operation in these patients.


Eligibility criteria: Inclusion Criteria:

* Patients in the department of Gynecology in the University hospital of Tampere, who underwent total pelvic exenteration with reconstruction of the pelvic floor.

Exclusion Criteria:

-

Primary outcomes:
measure: wound healing
timeFrame: 6 months
Secondary outcomes:
measure: operative time
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01453374: A Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration
Official title: A Phase 4, Pilot, Open-label Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opioid Dependence
Keywords: opioid dependence
VIVITROL
criminal justice
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2011-10-17
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase 4 study will evaluate the feasibility of initiating subjects on VIVITROL in prison and continuing VIVITROL upon release into the community.

Detailed description: This is an open-label study with a pre-post design. Pre-release opioid-dependent subjects from 4 Baltimore, MD area prisons (three for men and one for women) will receive 1 injection of VIVITROL prior to release from prison and will be offered 6 monthly injections of VIVITROL for 6 months post release. Subjects will complete follow-up visits 1 and 2 months after the last VIVITROL injection. Subjects will be assessed at 10 time points, and adherence to VIVITROL, both in prison and in the community, will be assessed.

Eligibility criteria: Inclusion Criteria:

* Not currently addicted to opioids, but has a diagnosis of pre-incarceration opioid dependence
* Inmate at the Metropolitan Transition Center (Baltimore, MD), Maryland Correctional Institute for Women (Jessup, MD), Baltimore Pre-Release Unit (Baltimore, MD), or Jessup Pre-Release Unit (Jessup, MD) and eligible for release within 30 days of screening
* Expressing a goal of opiate-free treatment upon release
* Currently opioid free
* Planning to live in the Baltimore, MD area for at least 8 months following prison release

Exclusion Criteria:

* Pregnancy and/or breastfeeding
* Clinically significant active medical condition
* Active hepatitis
* Past or present history of an AIDS-indicator disease in subjects who are infected with HIV
* Any untreated or unstable psychiatric disorder(eg, bipolar with mania)
* Recent suicidal ideation
* Current chronic pain diagnosis for which opioids are prescribed
* Positive drug test for opioids
* History of drug overdose within the past 3 years requiring inpatient hospitalization

Primary outcomes:
measure: Incidence of Subject Re-arrest
timeFrame: 7 months
Secondary outcomes:
measure: Incidence of Subject Re-incarceration
timeFrame: 7 months
measure: Opioid Use
timeFrame: 7 months
measure: Opioid Overdose
timeFrame: 7 months
measure: Drug Abuse Treatment Program Entry
timeFrame: 7 months
measure: Retention in the Community
timeFrame: 6 months
measure: Opioid Craving
timeFrame: 8 months
measure: Opioid Dependence
timeFrame: 7 months
measure: Cocaine Use
timeFrame: 6 months
measure: Criminal Activity
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Friends Research Institute
state: Maryland
Study officials:
affiliation: Alkermes, Inc.
name: Bernard L Silverman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00604565: Delivery of Soluble Ferric Pyrophosphate (SFP) Via the Dialysate to Maintain Iron Balance in Hemodialysis Patients
Official title: A Prospective, Randomized, Open-label, Multi-center, Controlled Clinical Trial of the Safety and Efficacy of Physiological Iron Maintenance in End Stage Renal Disease (ESRD) Subjects by Delivery of Soluble Ferric Pyrophosphate (SFP) Via Hemodialysate
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: End Stage Renal Disease (ESRD)
Keywords: Hemodialysis
Lead sponsor: Charles Drew University of Medicine and Science
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Rockwell Medical Technologies, Inc.
First posted: 2008-01-30
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In maintenance hemodialysis patients, regular administration of parenteral iron by addition of soluble ferric pyrophosphate (SFP) to the dialysate, when compared to conventional dialysate, is effective in preventing the development of iron deficiency, thereby maintaining hemoglobin level; is clinically safe and does not lead to oxidative stress or inflammation.


Eligibility criteria: Inclusion Criteria:Subjects with end stage renal disease undergoing maintenance hemodialysis three times a week.

* Subjects who have required IV iron at any time in the 2 months preceding enrollment.

Exclusion Criteria:

* Subjects with absolute iron deficiency at the time of enrollment In hemodialysis subjects "absolute iron deficiency"
* Subjects with a current malignancy involving sites other than skin.
* Subjects with a history of drug or alcohol abuse within the last 6 months

Primary outcomes:
measure: TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS
timeFrame: 36 weeks
measure: TOTAL NUMBER OF ADVERSE EVENTS
timeFrame: 36 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: RAI
state: California
city: Louisville
country: United States
facility: University of Louisville Kidney Disease Program
state: Kentucky
Study officials:
affiliation: Rockwell Medical Technologies, Inc.
name: Ajay Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04672265: Increasing Access to Breast Cancer Screening Among Immigrants
Official title: A Randomized Trial to Increase Access to Breast Cancer Screening by Invitation Language Among Immigrants in Norway
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer Screening
Keywords: cancer screening
breast cancer
non-native
immigrant
participation rate
invitation
information
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 11355
Sex: FEMALE
Minimum age (years): 48
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to receive the invitation in the major official native language in the country the participant is born and Norwegian, or in Norwegian only, consecutively when it is their turn to be invited to screening.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators aim to test whether inviting immigrants to breast cancer screening with a letter in their mother tongue in addition to the standard letter in Norwegian changes screening uptake in these immigrant groups, compared with a comparable group who receive the invitation in Norwegian only,

Detailed description: Women in selected immigrant groups according to birth country will be invited to screening and randomized in a 1:1 ratio to receive the screening invitation and information material 1) in the major official native language in the country the invitee is born in addition to Norwegian (intervention group), or 2) only Norwegian (control). The 13 selected countries of origin are Poland, the Philippines, Pakistan, Somalia and Arabic speaking countries (Iraq, Syria, Morocco, Lebanon, Algeria, Egypt, Palestine, Sudan and Tunisia). The five intervention languages will thus be Polish, English, Urdu, Somali and Arabic.

Eligibility criteria: Inclusion Criteria:

* Invited to screening program during the study recruitment period (January 2021-June 2022)
* The registered country of birth of the invitee is one of the following; Poland, Pakistan, Philippines, Somalia, Iraq, Syria, Morocco, Lebanon, Algeria, Egypt, Palestine, Sudan and Tunisia

Exclusion Criteria:

* Not reached with the screening invitation letter because of wrong address or similar

Primary outcomes:
measure: Screening attendance
timeFrame: 0-6 months after sent screening invitation letter
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Cancer Registry
Study officials:
affiliation: Norwegian Institute of Public Health
name: Paula Berstad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03330665: Meditation and Student Empathy
Official title: Meditation and Student Empathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Empathy
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Physician empathy and reducing stress are major factors in attaining positive clinical outcomes for patients. Fostering empathy in medical students is particularly important as they are the future of the healthcare workforce and a trend of declining empathy during medical education may lead to decreased health care quality outcomes. Meditation may be an avenue to promote positive student attitudes including empathy, though very few studies have examined this idea through empirical research. Using validated measures, the Jefferson scale of empathy and the perceived stress scale, we seek to investigate whether use of a meditation app will be associated with higher levels of self-rated empathy and lower self-rated stress.


Eligibility criteria: Inclusion Criteria:

-Medical students from New York Institute of Technology

Exclusion Criteria:

-Not a medical student

Primary outcomes:
measure: Perceived stress scale (PSS)
timeFrame: 6 months
measure: Jefferson scale of empathy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06279065: Investigation of the Influence of the Human Microbiome on Giant Cell Arteritis
Official title: Investigation of the Influence of the Human Microbiome on the Pathogenesis and Recurrence Probability in Giant Cell Arteritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Giant Cell Arteritis
Keywords: microbiome
Lead sponsor: University of Bonn
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: no specific requirements, usually over 50 years

Brief summary: The longitudinal observational study aims to assess the impact of the microbiome especially the gut-microbiome in the emergence and course of giant cell arteritis (abbr. GCA) patients. At diagnosis and 6 month follow up we will analyze the oral, blood and gut microbiome from GCA patients and healthy controls. Thereby identified potential candidate biota will be further analyzed for possible interactions and influence on the immune system.


Eligibility criteria: Inclusion Criteria:

• Diagnosis of Giant cell arteritis (only in one arm)

Exclusion Criteria:

* chronic infection (viral, fungi, bacteria) including human immunodeficiency viruses, Hepatitis B/C
* acute infection with usage of antibiotics less then 90 days before screening
* major gastro-intestinal surgery \<5 years from screening
* gastro-intestinal bleeding \<90 days before screening
* inflammatory bowel disease (confirmed bioptically)
* bulimia or anorexia nervosa
* adipositas (body mass index ≥ 40)
* intake of high dosage of probiotics (\>10\^9 colony forming units per day) \<90 days before screening
* not controlled Diabetes mellitus
* Malignancy within one year (except for squamous skin - and basal skin carcinoma without metastasis, cervix carcinoma with curative surgery, Cutaneous T-cell lymphoma)
* known abuse of alcohol oder drugs.

Primary outcomes:
measure: Significant differences in the composition of the microbiome
timeFrame: At Baseline and 6 month follow up
Secondary outcomes:
measure: Influence of the microbiome on therapy response e.g. increased probability of recurrence with accumulation of specific microbiome species
timeFrame: At Baseline and 2 year follow up
measure: potential association of microbiome composition with application of immune modulating drugs
timeFrame: At Baseline and 6 month follow up
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Clinical Immunology, University Hospital Bonn
state: North Rhine-Westphalia
city: Bonn
country: Germany
facility: University Hospital Bonn
Study officials:
References:
Clinical trial NCT03049865: Gait Speed at Discharge as a Marker for Readmission
Official title: Gait Speed at Discharge as a Marker for Readmission - The GASP Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: All Disease That May Require Acute Hospitalization Except for Phsychiatric Disease
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2017-02-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who are admitted to hospital from the emergency department are eligible for inclusion.

Brief summary: The principal aim is to assess if a simple test, the time it takes to walk 10 meters for a patient about to be discharged after a hospital stay for an acute illness, is related to the risk of readmission.


Eligibility criteria: Inclusion Criteria:

* \>50 years of age Patient discharged to home, or temporary short stay nursing home Expected survival \>90 days The ability to read or understand the instructions and to give informed consent.

Exclusion Criteria:

* Planned hospital stay, i.e. the patient was admitted electively The including investigator is directly involved in the care of the patient

Primary outcomes:
measure: Readmission
timeFrame: 30 days
Secondary outcomes:
measure: Readmissions
timeFrame: 90,180, 365 days
measure: All-cause mortality
timeFrame: 6, 12, 24, 36, 60 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04538365: Pre-surgical Antisepsis of Hands After Washing With Triclosan 0.5% Compared to Propan-1-ol 60%
Official title: Effect on the Reduction of Bacterial Load in Surgical Antisepsis of Hands After Washing With Triclosan 0.5% Compared to Propan-1-ol 60% Used as Reference Disinfectant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Antisepsis
Keywords: hand washing
presurgical antisepsis
Lead sponsor: Centro Ortopedico y Quirurgico del Pie
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover design is used
Primary purpose: TREATMENT

Brief summary: The present study evaluates the effects of bactericidal load reduction after surgical hand scrub antisepsis using the reference antiseptic product propanol-

1 60% as control versus a surgical hand scrub antisepsis with triclosan 0.5% in order to test if pass the standard european norm 12791.

Detailed description: The investigators conducted a crossover clinical trial to evaluate the antiseptic effectiveness of preoperative surgical scrubbing using propan-ol-1 60% by scrub using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand scrub antisepsis with trocilosan 0.5% in order to test if pass the standard european norm 12791. Samples will be taken from the hands of each volunteer after a surgical hands antiseptic.

Eligibility criteria: Inclusion Criteria:

* Participants without systemic pathologies, with healthy skin of the hands and short fingernails.
* They do not use substances with antibacterial action.

Exclusion Criteria:

* Taken antibiotics before 10 days of the intervention.
* Wear any jewellery on the hands

Primary outcomes:
measure: Reduction of bacterial load immediately after hand scrub
timeFrame: Change from bacterial load at 5 minutes
Secondary outcomes:
measure: Reduction of bacterial load after 3 hours of hand scrub
timeFrame: Change from bacterial load after 3 hours
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Facultad de Enfermeria, Fisioterapia y Podologia
Study officials:
affiliation: Universidad Complutense de Madrid
name: Ricardo B Becerro de Bengoa Vallejo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sante L, Gomez-Lus ML, Martin-Villa C, Becerro-de-Bengoa-Vallejo R, Alou L, Sevillano D. Effect on the reduction of bacterial load after surgical hand antisepsis with triclosan 0.5% compared to triclosan 0.5% followed by 70% alcoholic solution. Infect Control Hosp Epidemiol. 2023 Mar;44(3):517-519. doi: 10.1017/ice.2021.506. Epub 2021 Dec 22.
Clinical trial NCT01560065: Effect of Treatment With Myo-inositol on Human Semen Parameters in Patients Undergoing In Vitro Fertilization Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sperm Quality
Oligoasthenospermia
Lead sponsor: AGUNCO Obstetrics and Gynecology Centre
Sponsor class: OTHER
First posted: 2012-03-22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT

Brief summary: Myo-Inositol (MI) is a precursors for the synthesis of phosphatidylinositol polyphosphates (PIPs). In male reproduction, it was shown that MI concentration in the seminiferous tubules is higher than in serum and it was increasing during the movement through the epididymis and the deferent duct. In the present study, the role of myo-inositol has been investigated as a possible antioxidant agent for the systemic treatment of male infertility and the improvement of the sperm's quality.

Samples of seminal fluid were obtained from two groups of patients undergoing to a IVF cycle: healthy subjects and subjects with oligoasthenospermia (OA, \< 15 mil/ml). The collected samples were submitted to optic microscopy in order to evaluate semen's volume, spermatozoa's number and motility, during the initial semen analysis and after density gradient separation method; these parameters were evaluated before and after the administration of 4000mg/die of myo-inositol associated to 400 µg of folic acid for three months.

These values were compared with samples of seminal fluid of healthy patients undergoing to a IVF cycle for a female cause of infertility (control group).


Eligibility criteria: Inclusion Criteria:

* 3-5 days of sexual abstinence

Exclusion Criteria:

* systemic and endocrine diseases
* genital infections
* history of cryptorchidism or varicocele
* microorchidism
* hormonal treatment in the last six months
* alcohol intake, cigarette smoke and/or drug abuse

Primary outcomes:
measure: Semen volume
measure: Spermatozoa count
measure: Spermatozoa progressive motility
measure: Number of spermatozoa after density gradient separation method
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: University of Catania - Department of Surgery - Section of Obstetrics and Gynecology -Center of Physiopathology of Reproduction
Study officials:
References:
citation: Colone M, Marelli G, Unfer V, Bozzuto G, Molinari A, Stringaro A. Inositol activity in oligoasthenoteratospermia--an in vitro study. Eur Rev Med Pharmacol Sci. 2010 Oct;14(10):891-6.
citation: Hinton BT, White RW, Setchell BP. Concentrations of myo-inositol in the luminal fluid of the mammalian testis and epididymis. J Reprod Fertil. 1980 Mar;58(2):395-9. doi: 10.1530/jrf.0.0580395.
citation: de Ligny W, Smits RM, Mackenzie-Proctor R, Jordan V, Fleischer K, de Bruin JP, Showell MG. Antioxidants for male subfertility. Cochrane Database Syst Rev. 2022 May 4;5(5):CD007411. doi: 10.1002/14651858.CD007411.pub5.