louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01245322: Treatment of Bacterial Vaginosis Combined With Human Lactobacilli
Official title: Extended Antimicrobial Treatment of Bacterial Vaginosis Combined With Human Lactobacilli to Find the Best Treatment and Minimize the Risk of Relapses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bacterial Vaginosis
Keywords: treatment, lactobacilli
Lead sponsor: Skaraborg Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska University Hospital
First posted: 2010-11-22
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objectives of this study were to characterize lactobacilli of human vaginal origin and to investigate if more extended antibiotic treatment against Bacterial Vaginosis, together with adjuvant lactobacilli treatment, could increase the cure rate and furthermore, to investigate factors that could influence relapse.

Detailed description: Nine of the vaginal Lactobacillus strains isolated from healthy Swedish women and characterized in the present study were selected for the clinical trial.All women with symptomatic BV fulfilling the inclusion criteria were consecutively offered to participate in a prospective study of adjuvant lactobacilli given in addition to antibiotics. Women included were regularly menstruating women, 18 years or older, with normal gynaecological status, not pregnant or breast-feeding and without signs of other genital tract infections. Exclusion criteria were patients with hormonal intrauterine device without regular menstruation; women infected with Chlamydia trachomatis or with Trichomonas vaginalis, or with a clinical candida infection.

Eligibility criteria: Inclusion Criteria:

* were regularly menstruating women, 18 years or older, with normal gynaecological status, not pregnant or breast-feeding and without signs of other genital tract infections.

Exclusion Criteria:

* Exclusion criteria were patients with hormonal IUD without regular menstruation; women infected with Chlamydia trachomatis or with Trichomonas vaginalis, or with a clinical candida infection

Primary outcomes:
measure: characterize lactobacilli of human vaginal origin
timeFrame: 24 month
Secondary outcomes:
measure: cure rate after 24 month
timeFrame: 24 month
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Gynekologklinikken
Study officials:
affiliation: Skaraborg hospital and University College of Skövde, SE-541 85 Skövde, Sweden
name: Per-Göran Larsson, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Larsson PG, Brandsborg E, Forsum U, Pendharkar S, Andersen KK, Nasic S, Hammarstrom L, Marcotte H. Extended antimicrobial treatment of bacterial vaginosis combined with human lactobacilli to find the best treatment and minimize the risk of relapses. BMC Infect Dis. 2011 Aug 19;11:223. doi: 10.1186/1471-2334-11-223.
Clinical trial NCT06532422: Study of Post-operative Complications After Laparoscopic Outpatient Nephrectomy
Official title: Study of Post-operative Complications After Laparoscopic Outpatient Nephrectomy in Patients With Localised Kidney Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Cancer
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2024-08-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with localised kidney cancer, undergoing scheduled surgery for partial or total laparoscopic nephrectomy on an outpatient basis.

Brief summary: The purpose of this study is to compare to assess the incidence of post-operative complications related to nephrectomy, which occur up to 1 month after the operation.

Detailed description: This is an observational, prospective, open, non-comparative (single arm), single-centre study.

The study population consisted of adult patients diagnosed with localised kidney cancer and scheduled for outpatient partial or total laparoscopic nephrectomy.

Patients eligible for outpatient surgery will be identified during the initial consultation with the urological surgeon. When the indication for surgery has been validated at the multidisciplinary consultation meeting and is planned to be performed as an outpatient procedure, the study will be proposed to the patient by the investigator during the preoperative consultation.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 ;
* Localised kidney cancer ;
* Validation of curative treatment at a multidisciplinary consultation meeting;
* Partial or total laparoscopic nephrectomy scheduled on an outpatient basis;
* Membership of a social security scheme or receiving State Medical Aid;
* Patient able to understand the information relating to the study, to read the information leaflet and who has given his/her oral non-objection.

Exclusion Criteria:

* Emergency intervention ;
* Patient not eligible for outpatient treatment;
* Long-term curative anti-coagulant treatment ;
* Resident more than 100km from the clinic;
* Home alone on the first night;
* Patient of protected age (under guardianship or curatorship, or deprived of liberty).

Primary outcomes:
measure: Incidence of complications
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Clinique de la Sauvegarde
Study officials:
References:
Clinical trial NCT03009422: Fractional CO2 Laser With Topical Pentostam Treatment for Cutaneous Leishmaniasis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Leishmaniasis
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-01-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will compare the common treatment for cutaneous leishmaniasis with intra-lesional Pentostam to fractional CO2 laser with topical application of Pentostam.

Outcome will be final scar appearance assesd by two dermatologist and pain measurement by VAS.

Detailed description: 20 healthy patients diagnosed will cutaneous leishmaniasis with more than one lesion will be recruited.

Half of the lesions will be treated with intra-lesional injections of Pentostam, and the other half by CO2 laser with topical application of Pentostam.

Each lesion will recieve 3 treatments, one month apart between treatments. The patients will scale pain level of each treatment. Final scar appearance will be assessed by two dermatologists, without knowing what treatment was applied to each lesion.

Eligibility criteria: Inclusion Criteria:

* Objective cutaneous leishmaniasis diagnosis.
* More than one Lesion

Exclusion Criteria:

* Previous treatment
* Abnormal scarring

Primary outcomes:
measure: scar appearance
timeFrame: At sixth month
Secondary outcomes:
measure: Pain assessed by VAS
timeFrame: at one month, two months, and three months
Other outcomes:
Locations:
Study officials:
References:
citation: Monge-Maillo B, Lopez-Velez R. Therapeutic options for old world cutaneous leishmaniasis and new world cutaneous and mucocutaneous leishmaniasis. Drugs. 2013 Nov;73(17):1889-920. doi: 10.1007/s40265-013-0132-1.
citation: Al-Natour SH. Update in the treatment of cutaneous leishmaniasis. J Family Community Med. 2009 May;16(2):41-7.
citation: Arfan-ul-Bari, Simeen-ber-Rahman. Scar leishmaniasis. J Coll Physicians Surg Pak. 2006 Apr;16(4):294-5.
citation: Kim DW, Hwang NH, Yoon ES, Dhong ES, Park SH. Outcomes of ablative fractional laser scar treatment. J Plast Surg Hand Surg. 2015 Apr;49(2):88-94. doi: 10.3109/2000656X.2014.919927. Epub 2014 May 21.
citation: AlGhamdi K, Khurrum H. Successful treatment of atrophic facial leishmaniasis scars by co2 fractional laser. J Cutan Med Surg. 2014 Nov;18(6):379-84. doi: 10.2310/7750.2014.13175.
citation: Sklar LR, Burnett CT, Waibel JS, Moy RL, Ozog DM. Laser assisted drug delivery: a review of an evolving technology. Lasers Surg Med. 2014 Apr;46(4):249-62. doi: 10.1002/lsm.22227. Epub 2014 Mar 24.
citation: Bloom BS, Brauer JA, Geronemus RG. Ablative fractional resurfacing in topical drug delivery: an update and outlook. Dermatol Surg. 2013 Jun;39(6):839-48. doi: 10.1111/dsu.12111. Epub 2013 Jan 7.
Clinical trial NCT02619422: More Intensive Cardiac Rehabilitation Programs in Less Time
Official title: Multicenter, Prospective, Randomized, Open, Blinded for the End Point Evaluator to Compare Compliance to Secondary Prevention Measures After Acute Coronary Syndrome and Intensive Cardiac Rehabilitation Program vs Standard Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: Cardiac rehabilitation programs
Adherence to secondary preventive measures
Acute coronary syndrome
More intensive cardiac rehabilitation program in less time
Lead sponsor: Spanish Society of Cardiology
Sponsor class: OTHER
First posted: 2015-12-02
Enrollment: 509
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine if an intensive cardiac rehabilitation program with periodic reinforcements improve the compliance/adherence to secondary preventive measures (physical exercise, mediterranean diet, tobacco abstinence, pharmacological treatment) after an acute coronary syndrome with or without ST segment elevation versus an standard cardiac rehabilitation program


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Equal or older 18 years old
* Acute coronary syndrome with or without ST elevation within last two months
* Being able to do physical exercise
* Being able to understand the educative sessions
* Being able to understand patient information in the consent form

Exclusion Criteria:

* Hemodynamic instability
* Left ventricular ejection fraction (LVEF) \< or = 35%
* Heart failure class III -IV (New York Heart Association (NYHA) Functional Classification)
* Refractory angina
* Any pathology for which physical exercise is not indicated

Primary outcomes:
measure: Adherence to physical exercise
timeFrame: baseline-12 months
measure: Adherence to Mediterranean diet
timeFrame: baseline-12 months
measure: Tabacco abstinence
timeFrame: baseline-12 months
measure: Number of participants reporting compliance with prescribed treatments
timeFrame: baseline-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
References:
citation: Castro-Conde A, Abeytua M, Arrarte Esteban VI, Caravaca Perez P, Dalmau Gonzalez-Gallarza R, Garza Benito F, Hidalgo Urbano RJ, Torres Marques J, Vidal-Perez R, Nunez-Gil IJ. Feasibility and results of an intensive cardiac rehabilitation program. Insights from the MxM (Mas por Menos) randomized trial. Rev Esp Cardiol (Engl Ed). 2021 Jun;74(6):518-525. doi: 10.1016/j.rec.2020.03.029. Epub 2020 Aug 15. English, Spanish.
Clinical trial NCT02622022: Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease
Official title: Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Interstitial Lung Disease
Dyspnea
Morphine
Keywords: randomised
placebo controlled
clinical trial
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Skanderbog Apotek
First posted: 2015-12-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 36 patients with interstitial lung disease will be randomized to 1 weeks treatment with morphine hydrochloride as oral linctus 5 mg, four times a day, and 5 mg as needed up to 4 times a day, or corresponding doses of placebo.

VAS score for dyspnea will be evaluated after 1 hour and 1 week at follow up. Other questionnaires will also be evaluated (GAD-7, K-BUILD, Leicester score)


Eligibility criteria: Inclusion Criteria:

* A diagnosis of interstitial lung disease (IPF, NSIP, RA-ILS, Scl-ILS, MCTD-ILS, asbestous, drug induced ILD, unclassified ILD)
* Dyspnea corresponding to Medial Research Councils (MRC) dyspnea score ≥ 3
* Written consent
* Age ≥ 18 years
* Competent
* For fertile women: Negative pregnancy test
* For fertile and sexually active participants: Use of safe anti-conceptionals

Exclusion Criteria:

* Ongoing infection
* Decreased lung function to a degree which makes any form of respiratory depression life threatening
* Treatment with morphine or morphine analogues
* Allergy towards morphine hydrochloride

Primary outcomes:
measure: VAS dyspnea score
timeFrame: 1 week
Secondary outcomes:
measure: Oxygen saturation
timeFrame: 1 hour and 1 week
measure: K-bild questionnaire
timeFrame: 1 week
measure: GAD-7 questionnaire
timeFrame: 1 week
measure: 6 min walk test
timeFrame: 1 hour and 1 week
measure: Leicester Score
timeFrame: 1 week
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
citation: Kronborg-White S, Andersen CU, Kohberg C, Hilberg O, Bendstrup E. Palliation of chronic breathlessness with morphine in patients with fibrotic interstitial lung disease - a randomised placebo-controlled trial. Respir Res. 2020 Jul 23;21(1):195. doi: 10.1186/s12931-020-01452-7.
Clinical trial NCT02716922: Cerclage for Singletons With Short Cervix Without Prior Preterm Birth
Official title: Cervical Cerclage for Singleton Gestations With Short Cervix and Without Prior Preterm Birth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Preterm Birth
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Preterm birth remains the most common cause of perinatal morbidity and mortality. A short cervi- cal length on transvaginal ultrasonography has been shown to be one of the best predictors of preterm birth. In 2005 a meta-analysis by Berghella et al. showed that cervical cerclage does not prevent preterm birth (PTB) in women with short cervical lenght without prior PTB. However maybe the meta-analysis did not reach the statistical significance due to the small sample size


Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy (limits the participants to female gender)
* Short cervical length (less than or equal to 25 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation
* 18-50 years of age

Exclusion Criteria:

* Multiple gestation
* Prior spontaneous preterm birth 16-36 6/7 weeks
* Ruptured membranes
* Lethal fetal structural anomaly
* Fetal chromosomal abnormality
* Pessary in place (or planned placement)
* Vaginal bleeding
* Suspicion of chorioamnionitis
* Ballooning of membranes outside the cervix into the vagina or CL = 0 mm on transvaginal ultrasound
* Painful regular uterine contractions
* Placenta previa

Primary outcomes:
measure: Spontaneous preterm birth rates <34weeks
timeFrame: Less than 34 weeks gestation
Secondary outcomes:
measure: Spontaneous preterm birth rates <37, <28 and <24 weeks
timeFrame: Less than 24, 28, and 37 weeks gestation
measure: Type of delivery
timeFrame: Time of delivery
measure: Spontaneous rupture of membranes
timeFrame: Less than 34 weeks gestation
measure: Neonatal death
timeFrame: Between birth and 28 days of age
measure: birth weight
timeFrame: Time of delivery
measure: Chorioamnionitis
timeFrame: Time of delivery
measure: necrotizing enterocolitis
timeFrame: Between birth and 28 days of age
measure: intraventricular hemorrhage
timeFrame: Between birth and 28 days of age
measure: respiratory distress syndrome
timeFrame: Between birth and 28 days of age
measure: bronchopulmonary dysplasia
timeFrame: Between birth and 28 days of age
measure: blood-culture proven sepsis
timeFrame: Between birth and 28 days of age
measure: neonatal mortality
timeFrame: Between birth and 28 days of age
measure: perinatal death
timeFrame: Until 28 days of age
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Gabriele Saccone
Study officials:
References:
Clinical trial NCT00653822: A Study of Pharmacokinetics and Safety of Alefacept in Caucasian and Japanese Healthy Volunteers
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single Dose Study to Assess the Tolerability, Safety, and Pharmacokinetics of Alefacept in Caucasian and Japanese Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics of Alefacept
Keywords: Amevive
alefacept
pharmacokinetics
Japanese
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-04-07
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective of this study is to compare the pharmacokinetic and pharmacodynamic properties and safety profile of alefacept in Caucasian and Japanese healthy subjects


Eligibility criteria: Inclusion Criteria:

* Caucasian or Japanese healthy subject with a body mass index (BMI) of 18 to 29 kg/m2, inclusive
* Japanese subject is first generation, born in Japan from parents of Japanese decent, and has resided outside of Japan for 5 years or less OR Caucasian subject is Hispanic or non-Hispanic, born of parents of European decent (not Mestizo or mixed race)
* Subject must have clinical laboratory test results within the normal therapeutic range or, if abnormal, the results are not clinically significant as determined by the investigator

Exclusion Criteria:

* CD4+ lymphocyte count outside normal limits at Screening
* Received vaccine within 60 days prior to study drug administration
* History of drug or alcohol abuse within the 2 years prior to the study drug administration
* Treatment with any systemic immunosuppressant agent within 6 months prior to study drug administration
* Treatment with any antibody or biologic product within 6 months prior to study drug administration
* Treatment with any systemic steroid or steroid inhaler within 2 months prior to study drug administration
* A smoking habit of greater than 10 cigarettes a day

Primary outcomes:
measure: Serum alefacept pharmacokinetic parameters
timeFrame: Days 1-8,15, 22, 29 and 43
Secondary outcomes:
measure: Pharmacodynamic parameters of total lymphocyte count and peripheral lymphocyte subsets
timeFrame: Days 1-8, 15, 22, 29 and 43
measure: Safety variables including anti-alefacept antibodies
timeFrame: Days 1-8, 15, 22, 29 and 43
Other outcomes:
Locations:
city: Glendale
country: United States
state: California
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
Clinical trial NCT02007122: Multiple-dose Pharmacokinetics of Ceftaroline During Continuous and Intermittent Renal Replacement Therapy in Patients Requiring Renal Replacement Therapy
Official title: Multiple-dose Pharmacokinetics of Ceftaroline During Continuous and Intermittent Renal Replacement Therapy in Patients Requiring Renal Replacement Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infection During Renal Replacement Therapy
Keywords: HD
CVVH
renal replacement therapy
ceftaroline
pharmacokinetics
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 25
Sex: ALL
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 study will be conducted to investigate the pharmacokinetics of ceftaroline during continuous and intermittent renal replacement therapy.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years, able to give written informed consent
* Suspected or proven bacterial infection requiring parenteral antibiotic therapy.
* Renal replacement therapy (continuous or intermittent)

Exclusion Criteria:

* Known hypersensitivity to ceftaroline or other cephalosporins, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents.
* An expected survival of less than two days.
* Known pregnancy
* Coadministration of valproic acid or probenecid, which cannot be discontinued for the duration of the study
* Ceftaroline as monotherapy for resistent species or fungal infections.
* Other reasons oposing the study participation on the discretion of the investigators

Primary outcomes:
measure: Influence of renal replacement therapy on the area under concentration curve of ceftaroline plasma concentration levels.
timeFrame: day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT02984722: Extended-release vs Immediate-release Metformin in PCOS Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
metformin
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study is to compare the different effects of 6 months treatment with extended-release metformin and immediate-release metformin on clinical, endocrine and metabolic parameters in women affected by polycystic ovary syndrome. We also evaluate gastrointestinal disorders associated with the two different compouds.


Eligibility criteria: Inclusion Criteria:

* women with PCOS in accordance with Rotterdam criteria

Exclusion Criteria:

* pregnancy
* diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test)
* past history of cardiovascular diseases
* past history of gastro-intestinal diseases
* significant liver or renal dysfunction (hypothalamic, pituitary, thiroidal or adrenal);
* neoplasms.

Primary outcomes:
measure: Gastro intestinal disorders
timeFrame: 6 months
Secondary outcomes:
measure: number of cycles in 6 months of therapy
timeFrame: 6 months
measure: insulin levels
timeFrame: 6 months
measure: hirsutism score
timeFrame: 6 months
measure: androstenedione levels
timeFrame: 6 months
measure: testosterone levels
timeFrame: 6 months
measure: free androgen index
timeFrame: 6 months
measure: dheas levels
timeFrame: 6 months
measure: ovarian volume
timeFrame: 6 months
measure: total cholesterol
timeFrame: 6 months
measure: tryglycerides levels
timeFrame: 6 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic university of Sacred Heart
Study officials:
References: