louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06648850: Clinical Study of DA-001 as a Treatment for Telogen Effluvium
Official title: Clinical Study of DA-001 as a Treatment for Telogen Effluvium
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Telogen Effluvium
Keywords: Hair Shedding
Lead sponsor: Applied Biology, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Follea International Limited
name: Daniel Alain, Inc.
First posted: 2024-10-18
Enrollment: 480
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to assess the safety and efficacy of DA-001 as a treatment for telogen effluvium

Detailed description: DA-001 is a topical alpha 1 agonist combined with a TAAR receptor agonist. DA-001 was studied in a population of women that suffer from excessive hair shedding. DA-001 demonstrated significant reduction in hair shedding.

This study aims to assess the safety and efficacy of DA-001 as a treatment for telogen effluvium.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Diagnosed with telogen effluvium
* Willing and able to apply the treatment as directed, comply with study
* Otherwise healthy
* Able to give informed consent

Exclusion Criteria:

* A medical history that may interfere with study objectives
* Women who are pregnant, lactating, or planning to become pregnant during the study period
* Subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc)
* Subjects who have known allergies to any excipient in DA-001
* Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device in the treatment area within 30 days prior to study treatment initiation
* Subjects who have used any topical prescription medications in the treatment area within 30 days prior to study treatment initiation
* Subjects who have had a dermatological procedure such as surgery in the treatment area within 30 days prior to study treatment initiation
* Subject is unable to provide consent or make the allotted clinical visits

Primary outcomes:
measure: Number of Hairs Shedding
timeFrame: Minutes [0,5]
Secondary outcomes:
measure: Number of Hairs Shedding
timeFrame: Week [0,4]
Other outcomes:
Locations:
Study officials:
affiliation: University of Rome G. Marconi
name: Andy Goren, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03524950: Effect of Dexmedetomidine on Stress Study of Pituitrin in Laparoscopic Hysteromyoma Surgery
Official title: Effect of Dexmedetomidine on Stress Study of Pituitrin in Laparoscopic Hysteromyoma Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hysteromyoma
Keywords: stress
dexmedetomidine
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2018-05-15
Enrollment: 90
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is about the effect of dexmedetomidine to the stress of pituitrin in laparoscopic hysteromyoma surgery. It is well known that pituitrin has been widespread used in the laparoscopic hysteromyoma surgery. Pituitrin includes oxytocin and vasopressin. Vasopressin increase body stress reaction through hypothalamic pituitary adrenal(HPA) axis. The HPA axis has has main role to the body stress reaction. Dexmedetomidine can inhibit the stress responses mediated by the sympathetic nervous system. Therefore,the effect of dexmedetomidine to the stress of pituitrin in laparoscopic hysteromyoma surgery is worth to be studied.


Eligibility criteria: Inclusion Criteria:

Surgery will be scheduled as first case in the morning at 9 Am. On arrival to the operation room, intravenous access will be achieved with venous cannula under local anesthesia with 2% lidocaine. Monitoring consisted of 5 lead electrocardiography, pulse oximeter, noninvasive blood pressure, end tidal carbon dioxide, and bispectral index.

Exclusion Criteria:

Diabetic,chronic hypertension,patients on drugs such as beta blockers or calcium channel blockers,pregnant or lactating women, patients with abnormal serum creatinine and blood urea nitrogen, and patients with a history of allergy to drugs particularly α2 agonists.

Primary outcomes:
measure: acth
timeFrame: the acth before using pituitrin 5 minutes
measure: acth
timeFrame: the acth after using pituitrin 20 minutes
measure: acth
timeFrame: the acth after using pituitrin 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00822250: Clinical and Biological Study of Sub-pigmentation During Infantile Cystinosis
Official title: Clinical and Biological Study of Sub-pigmentation During Infantile Cystinosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystinosis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2009-01-14
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the molecular mechanism of this disease and to research the relationship between cystinosis and skin phenotype.


Eligibility criteria: Inclusion Criteria:

1. cystinosis
2. known CTNS mutation

Exclusion Criteria:

1. patient with corticotherapy treatment
2. patient with immunosuppressant treatment

Primary outcomes:
measure: to determine molecular mechanism of the disease
timeFrame: at time= 0
Secondary outcomes:
measure: to research relationship between skin phenotype and cystinosis
timeFrame: at time =0
Other outcomes:
Locations:
city: Nice
country: France
facility: department of dermatology, Nice University Hospital
Study officials:
References:
Clinical trial NCT01116050: Intrarectal Misoprostol in Postpartum Haemorrhage
Official title: Second-line Treatment of Post-partum Haemorrhage With Intrarectal Misoprostol: a Multicentre, Double Blind, Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postpartum Haemorrhage
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2010-05-04
Enrollment: 116
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postpartum haemorrhage (PPH) remains the major cause of maternal mortality in France. The most efficient treatment of severe PPH is sulprostone which is associated with cardiac complications. The objective of this study was to assess the efficacy and the safety of intrarectal misoprostol for curative postpartum haemorrhage treatment.

We conducted a multicenter double blind randomized placebo control trial between June 2004 and December 2007, among consenting women with postpartum haemorrhage and failure to oxytocin treatment.

Our main criteria of judgement was quantification of blood loss and the use of sulprostone between the two groups using either misoprostol intrarectal tablets (5X200mg ) or placebo in similar opaque introducer.


Eligibility criteria: Inclusion Criteria:

* Older than 18 yrs old
* Giving birth after 32 Weeks of amenorrhea
* Post-partum haemorrhage due to atony
* Inefficiency off the first line treatment
* Written signed consent form

Exclusion Criteria:

* known allergy to prostaglandin
* haemostasis anomalies before labour
* anticoagulant treatment
* fetal death
* accreta or percreta placenta
* under 18 years
* delivery before 32 weeks of amenorrhea
* post-partum bleeding not suspected to be due to atonic uterus

Primary outcomes:
measure: quantification of blood loss
timeFrame: 15 minutes after treatment administration
Secondary outcomes:
measure: Sulprostone Requirement
timeFrame: 30 minutes after the diagnostic of post-partum hemorrhage
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Caen
name: Michel DREYFUS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2.
Clinical trial NCT04311450: Behavioral Weight Loss Treatment for Individuals With Food Addiction
Official title: Behavioral Weight Loss Treatment for Individuals With Food Addiction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Addiction
Overweight and Obesity
Weight Loss
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to examine how well an existing weight loss treatment works for individuals with food addiction. Treatment will consist of a preliminary 12-week RCT pilot of the feasibility and effectiveness of behavioral weight loss (BWL) compared to a waitlist control.


Eligibility criteria: Inclusion Criteria:

* BMI 25-50 kg/m2
* Meets criteria for Food Addiction (based on the self-report score from the Yale Food Addiction Scale)
* Available for the duration of the treatment (3 months)
* Read, comprehend, and write English at a sufficient level to complete study-related materials.
* Availability of internet to participate in study interventions (i.e., electronic SMART scales)

Exclusion Criteria:

* Co-existing psychiatric condition that requires hospitalization or more intensive treatment (e.g., bipolar mood disorders, psychotic illnesses, severe depression).
* Reports active suicidal or homicidal ideation
* Current anorexia or bulimia nervosa
* Endorsing current or history of heart trouble/chest pain.
* Breast-feeding or pregnant, or planning to become pregnant during the study.
* History of stroke or myocardial infarction.
* Current or recent (within 12 months) drug or alcohol dependence
* Currently receiving effective treatment for eating or weight loss, including individual who received bariatric surgery within the past five years
* Currently participating in another clinical study.

Primary outcomes:
measure: Weight (e.g., change in percent weight loss)
timeFrame: Up to 12 weeks
measure: Food addiction (change in food addiction scores)
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Food Craving (change in food craving scores)
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
References:
Clinical trial NCT03388450: Omega-3 Fatty Acid for Critically Ill Patients.
Official title: Effect of Enteral Nutrition With Omega-3 Fatty Acid in Critically Ill Septic Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Sepsis is the most common reason for intensive care unit (ICU) admission. Sepsis flares up the systemic inflammatory response with its mediators. Sepsis treatment protocols have been established in many centres with immune nutrient as adjuvant treatment. Omega-3 fatty acid and other anti-oxidants formulae have been found to improve sepsis outcome. In most of the studies, immune nutrients were giving parenterally, however, nowadays the preferable route of feeding in critically ill patients is enterally. The present study was done to investigate the effect of enteral Omega-3 fatty acid in septic critically ill patients.

Detailed description: A hundred and ten critically ill septic patients were included in the study. Patients were divided into two groups fifty-five patients each. Group A received enteral nutrition supplemented with Omega-3 fatty acid and group B received enteral nutrition without Omega-3. Demographic data, sepsis characteristics, number of patients required invasive ventilation, ventilation days, ICU sequential organ failure assessment score (SOFA), organ failure free-days, haemodynamic failure free-days, ICU stay, ICU and hospital outcomes were recorded.

Eligibility criteria: Inclusion Criteria:

* All septic patients who could receive enteral nutrition were included in the study

Exclusion Criteria:

* Patients with end stage liver or renal disease, haemodynamic instability, immunosuppression, gastrointestinal comorbidity, allergic to omega-3, received omega-3 a week prior to ICU admission, patients who expected to live less than 24 hours, and patients who were mechanically ventilated on ICU admission were excluded from the study.

Primary outcomes:
measure: Organs dysfunction free days.
timeFrame: 25 days during ICU stay.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05248750: Genetic, Microenvironmental, and Immunological Factors in Unresectable Pancreatic Ductal Adenocarcinoma
Official title: Genetic, Microenvironmental, and Immunological Factors in Unresectable Pancreatic Ductal Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreas Cancer
Keywords: pancreatic cancer
endoscopic ultrasound (EUS)
personalized medicine
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study concerns consecutive individuals with a solid pancreatic lesion who will undergo diagnostic EUS-FNB over a 3 year period. Those with a histological diagnosis of PDAC will be enrolled in the study. Enrollment will include patients with unresectable disease, which can be divided in different stages, i.e. borderline resectable, locally advanced, and metastatic.

Brief summary: Pancreatic ductal adenocarcinoma (PDAC) complexity, where genetic, stromal, and immunological factors all interact with each other, is responsible for the overall poor response of PDAC to chemotherapeutic agents, making this a lethal disease. The investigators hypothesize that: (i) dissection of genetic, stromal, and immunological factors on endoscopic ultrasound fine needle biopsy (EUS-FNB) tissue samples from unresectable PDAC patients' will allow to determine prognostic factors in this patient population; (ii) treatment response and acquisition of tumor chemotherapy resistance could be related to genetic heterogeneity between the primary and metastatic sites and alteration of the molecular profile under drug' selection pressure.


Eligibility criteria: Inclusion Criteria:

* Patients referred to EUS with FNB for suspected pancreatic cancer unresectable or metastatic based on imaging findings
* Availability of biopsies obtained during EUS-FNB
* Histological diagnosis of pancreatic ductal adenocarcinoma of any stage
* Patients must be fit for chemotherapy administration
* They have to express their willingness to be followed up at our pancreatic high volume centers
* Age \>18 and \<80 years
* Able to sign informed consent

Exclusion Criteria:

* Histological diagnoses other than pancreatic ductal adenocarcinoma
* Pregnancy or lactation

Primary outcomes:
measure: Progression-free-survival (PFS)
timeFrame: From date of enrollment assessed until death or up to 2 years
measure: Overall survival
timeFrame: From date of enrollment assessed until death or up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Agostino Gemelli" Hospital, Catholic University of Sacred Heart
state: Lazio
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli
name: Alberto Larghi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00537550: Adult ALL Treatment at Diagnosis
Official title: GIMEMA Guidelines for the Treatment of Adult ALL Affected Patients at Diagnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leukemia, Lymphocytic, Acute
Keywords: ALL
Adult
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2007-10-01
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present study has been designed to give participating centers the possibility of better understanding the diagnostic and prognostic factors of ALL patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of acute lymphoblastic leukemia (ALL)
* Negative myeloperoxidase stain
* Phenotype T (ALL-T) and B(ALL-B)

Exclusion Criteria:

* Creatinine \> 2.5mg/dL after adequate hydratation
* LVEF \<50%
* Presence of documented infections not responding to antibiotic and/or antifungal therapy
* Presence of concomitant malignant diseases
* Absence of any psychological condition that does not allow to intake high doses of cortisone
* Patients who have received any antineoplastic chemiotherapy for more than 5 days
* Patients who have received any steroids for more than 10 days

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Avellino
country: Italy
facility: Az. Ospedaliera S. G. Moscati
city: Bologna
country: Italy
facility: Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
city: Brindisi
country: Italy
facility: Ospedale Reg. A di Summa
city: Potenza
country: Italy
facility: Istituto di Ematologia- Ospedale San Carlo
city: Verona
country: Italy
facility: Policlinico G.B. Rossi
Study officials:
affiliation: Università degli Studi di Roma "La Sapienza"
name: Franco MANDELLI, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piciocchi A, Messina M, Elia L, Vitale A, Soddu S, Testi AM, Chiaretti S, Mancini M, Albano F, Spadano A, Krampera M, Bonifacio M, Cairoli R, Vetro C, Colella F, Ferrara F, Cimino G, Bassan R, Fazi P, Vignetti M. Prognostic impact of KMT2A-AFF1-positivity in 926 BCR-ABL1-negative B-lineage acute lymphoblastic leukemia patients treated in GIMEMA clinical trials since 1996. Am J Hematol. 2021 Sep 1;96(9):E334-E338. doi: 10.1002/ajh.26253. Epub 2021 Jun 9. No abstract available.
Clinical trial NCT02553850: An Observational Study in Patients With Breast Cancer and Bone Metastases Receiving Ibandronate (Bondronat)
Official title: A SURVEY TO STUDY THE CORRELATION BETWEEN THE SERUM LEVELS OF BONE TURNOVER MARKERS AND THE CLINICAL PICTURE IN PATIENTS WITH BREAST CANCER AND BONE METASTASES RECEIVING IBRADONIC ACID TREATMENT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-09-18
Enrollment: 442
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with breast cancer and bone metastases who have been prescribed ibandronate (Bondronat) will be evaluated in the routine oncological setting for 12 months.

Brief summary: This open non-randomized, single-arm, multicenter, observational study is designed to evaluate the correlation between bone turnover markers and the response to treatment in patients with breast cancer and bone metastases. In this observational study, ibandronate (Bondronat) will be prescribed and used in accordance with the standards of care. Data will be collected for 12 months.


Eligibility criteria: Inclusion Criteria:

* All criteria in accordance with the Summary of Product Characteristics of Bondronat (ibandronate)
* Adult patients greater than (\>) 18 years of age
* Histologically confirmed breast cancer
* Confirmed bone metastasis (by bone scintigraphy, X-ray, computed tomography or magnetic resonance imaging)
* Life expectancy \>6 months
* No previous bisphosphonate therapy
* Patients signed written informed consent form before study start

Exclusion Criteria:

* All criteria in accordance with the Summary of Product Characteristics of Bondronat(ibandronate)
* Hypersensitivity to the active substance or any of the excipients of Bondronat (ibandronate)
* Hypersensitivity to bisphosphonates

Primary outcomes:
measure: Beta C-terminal telopeptide (B-CTx) level
timeFrame: 12 months
measure: Treatment response rate
timeFrame: 12 months
Secondary outcomes:
measure: Number of patients who died due to progression of breast cancer
timeFrame: 12 months
measure: Safety: Incidence of adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Gyor
country: Hungary
city: Gyula
country: Hungary
city: Kaposvar
country: Hungary
city: Nyíregyháza
country: Hungary
city: Pecs
country: Hungary
city: Szeged
country: Hungary
city: Szeged
country: Hungary
city: Szekesfehervar
country: Hungary
city: Szekszard
country: Hungary
city: Szolnok
country: Hungary
city: Szombathely
country: Hungary
city: Tatabánya
country: Hungary
city: Veszprem
country: Hungary
city: Zalaegerszeg-Pozva
country: Hungary
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: