louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06882031: Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution Under Fasting and Fed Conditions, to Compare Intravenous Arsenic Trioxide, in Acute Promyelocytic Leukemia
Official title: A Randomized, Open Label, Single-Centre, Single-Dose, 4-Period, 4-Treatment Cross-over Study to Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution (SDK001) Under Fasting and Fed Conditions, to Compare to Intravenous Arsenic Trioxide, and to Evaluate Interaction With Calcium Carbonate in Patients With Acute Promyelocytic Leukemia.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Acute Promyelocytic Leukemia (APL)
Keywords: APL
Lead sponsor: SDK Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: The University of Hong Kong
First posted: 2025-03-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Randomized, Open-Label Study to evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution (SDK001) under Fasting and Fed Conditions, to Compare to IV Arsenic Trioxide


Eligibility criteria: Inclusion Criteria:

-Diagnosis of APL characterized by the presence of the t(15;17) translocation or promyelocytic leukemia/retinoic acid receptor alpha gene expression

Exclusion Criteria:

* Relapsed or refractory APL

Primary outcomes:
measure: A Randomized, Open Label, Single-Centre, Single-Dose, 4-Period, 4-Treatment Cross-over Study to Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution (SDK001) to Intravenous Arsenic Trioxide
timeFrame: Over 4 weeks in maintenance cycle
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong-Clinical Trial Centre Phase 1 Centre
Study officials:
References:
Clinical trial NCT01139931: Biomarker Changes in Samples From Young Patients With Acute Myeloid Leukemia
Official title: Epigenetic Alterations in AML
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: childhood acute myeloid leukemia/other myeloid malignancies
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-06-09
Enrollment: 15
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of acute myeloid leukemia

Brief summary: RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the laboratory may help doctors learn about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarker changes in samples from young patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:

* Map key histone modifications and cytosine methylation in leukemia cell lines with defined oncogenic mutations.
* Acquire genome-wide maps of key histone modifications and cytosine methylation for primary leukemia in samples from patients with acute myeloid leukemia (AML).
* Investigate functional relationships between genetic and epigenetic landscapes in AML.

OUTLINE: Archived samples are analyzed in vivo and in vitro (cell line) for histone modification and cytosine methylation. Genome-wide locations of 5 histone modifications are analyzed using chip-Seq, as well as DNA methylation analysis at nucleotide-resolution by high-throughput bisulfite sequencing. These epigenetic data are correlated with genomic data (sequence analysis, expression array, SNP array).

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia
* Primary leukemia samples from the Children Oncology Group (COG) bank with sufficient number of cells (500,000-1 million cells) with \> 80% of leukemia blasts

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Relationships between genetic and epigenetic landscapes in AML
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Soheil Meshinchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00548431: NOPHO ALL-2008 Pilot Study on Consolidation Therapy for Children and Adolescents With Acute Lymphoblastic Leukemia
Official title: Phase II Study of Individual 6-mercaptopurine(6MP) Dose Increments in Children With Acute Lymphoblastic Leukemia (ALL) Receiving High-dose Methotrexate (HDM) and PEG-asparaginase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia, Lymphocytic, Acute
Keywords: Leukemia, Lymphocytic, Acute [C04.557.337.428.511]
6-mercaptopurine
methotrexate
asparaginase
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2007-10-24
Enrollment: 38
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present pharmacokinetic (PK)-pharmacodynamic (PD) study will explore the toxicity and antileukemic response during the initial 3 months of individualised therapy of children and young adults with acute lymphoblastic leukemia (ALL). The investigators will on an individual toxicity-titrated basis attempt to increase the dose intensity of the 6-mercaptopurine used in the two-months post-remission treatment phase of lower risk childhood ALL. This will be performed together with continuous PEG-ASP (every 2nd week) and interspersed HD-MTX (5 g/m\^2) every 3rd week. Thus, the trial will also test the feasibility of this particular drug combination.

Detailed description: In addition to the details above we will also explore

* the relationship of the post-HD-MTX MRD-levels with the dose of 6MP, TPMT-activity, DNA-6TGN, E-6TGN, E-MeMP, E-MTX, and presence of ASP-antibodies,
* the early development of anti-ASP antibodies during continuous PEG-ASP therapy.

The study could improve the understanding of the pharmacodynamics of the 6MP/HD-MTX interaction in combination with PEG-ASP.

Eligibility criteria: Inclusion Criteria:

* B-lineage ALL
* 1-17.9 years
* WBC \<100, clinical remission obtained day 2
* Written consent to participation.

Exclusion Criteria:

* t(9;22)
* Hypodiploidy
* 11q23-aberrations
* TPMT-deficiency
* Intolerance to MTX or 6MP

Primary outcomes:
measure: Toxicity of Treatment in Terms of Number of Participants With Serious Adverse Events or Adverse Events, Reported
timeFrame: 3 months ( 79 days )
Secondary outcomes:
measure: Incorporation of 6-thioguanine Nucleotides (6TGN) Into Leukocyte DNA, Development of Asparaginase Antibody Production
timeFrame: During the 3 months consolidation therapy
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Pediatrics, Rigshospitalet
city: Odense
country: Denmark
facility: Department of Pediatrics, University Hospital
city: Gothenburg
country: Sweden
facility: Department of Pediatrics, Drottning Sylvias Pediatric Hospital
Study officials:
affiliation: Pediatric Clinic II, RIgshospitalet, Copenhagen, DK-2100
name: Kjeld Schmiegelow, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05697731: Evaluation of Vidiac Scores of Obese and Non-obese Patients Intubated by Videolaryngoscopy
Official title: Evaluation of Vidiac Scores of Obese and Non-obese Patients Intubated by Videolaryngoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vidiac Score
Videolaryngoscopy
Obesity
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients to be operated under general anesthesia and endotracheal intubation

Brief summary: The aim of the study was to observe the vidiac score values of only patients with obesity as a risk factor for difficult intubation. Secondly, it was aimed to evaluate the number of intubation attempts and intubation time, vidiac scores between non-obese and obese patients and to reveal the differences, if any.


Eligibility criteria: Inclusion Criteria:

* All patients to be operated under general anesthesia and endotracheal intubation

Exclusion Criteria:

1. under 18 years old
2. The patient's refusal
3. Difficult airway story before
4. Congenital or previous airway anatomical disorder
5. Patients who have undergone airway surgery
6. Patients with a mass in the head and neck region

Primary outcomes:
measure: vidiac score
timeFrame: during entubation
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Aysun Postacı, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06423131: Prospective Clinical Trial for Children With TCRαβ Depleted vs Traditional Haplo Identicle HSCT
Official title: TCRαβ+ Cell Deleted Versus Traditional Haploidentical Hematopoietic Stem Cell Transplantation ：A Single-center, Prospective, Non-randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Graft-Versus-Host Disease
Hematopoietic Stem Cell Transplantation
Child, Only
Haploidentical Hematopoietic Stem Cell Transplantation
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 110
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: TCRαβ depleted HSCT compare to traditional Beijing haploidentical HSCT
Primary purpose: TREATMENT

Brief summary: This is a single-center prospective, non-randomized controlled clinical study in China using CliniMACS TCRα/β+ cell depleted stem cell haploidentical donors versus conventional Beijing protocol for haploidentical hematopoietic stem cell transplantation in children.

Detailed description: 1:1 non-randomized controlled clinical study in single center using CliniMACS TCRα/β+ cell depleted stem cell versus conventional Beijing protocol for haploidentical hematopoietic stem cell transplant. The purpose of this study is to obtain 30% decrease grade II-IV aGVHD and better qulity of life for TCRα/β+ cell depleted haploidentical stem cell transplantaion.

Eligibility criteria: Inclusion Criteria:

* Age 8 weeks to 18 years
* Children who meet the indicators haploidentical hematopoietic cell transplantation
* No HLA ≥ 9/10 donor or not suitable for this type of donor due to illness
* Informed consent must be signed (by the patient or legal representative)

Exclusion Criteria:

* Liver function abnormalities with bilirubin \>2 mg/dL and elevation of transaminases higher than 400 U/L
* Chronic active viral hepatitis
* Ejection fraction \<50%
* Respiratory failure necessitating supplemental oxygen
* Patients with a history of psychiatric illness or a condition which could interfere with their ability to understand the requirements of the study
* Patients unwilling or unable to comply with the protocol or unable to give informed consent
* Concurrent severe or uncontrolled infection

Primary outcomes:
measure: Incidence of grade II-IV acute GVHD
timeFrame: day+100
measure: incidence of treatment related mortality(TRM)
timeFrame: day +100
Secondary outcomes:
measure: post HSCT day 1y and 2y GRFS and OS
timeFrame: day +1y and +2y
measure: cGVHD post day 1y and 2y
timeFrame: day +1y and +2y
measure: TRM post day +1y and +2y
timeFrame: day +1y and +2y
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Shanghai Children's Medical Center
name: Jing Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06625931: Clinical Trial to Evaluate the Safety and Efficacy of NTCB01-1 in Patients Who Require Parenteral Nutrition
Official title: A Randomized, Open-labeled, Multi-center, Active-controlled, Parallel-group Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of NTCB01-1 Versus NTCB-P in Patients Who Require Parenteral Nutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parenteral Nutrition
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2024-10-03
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized, Open-labeled, Multi-center, Active-controlled, Parallel-group Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of NTCB01-1 versus NTCB-P in patients who require parenteral nutrition


Eligibility criteria: Inclusion Criteria:

* Those who are 19 years old or older at the screening visit
* Patients are expected to require PN for more than 3 days
* Patients who voluntarily signed the consent form

Exclusion Criteria:

* Patients are expected difficult to survive more than 3 days
* Patients BMI is over 30 kg/m2
* Patients having hypersensitivity to any peanut-, fish-, soy-, egg protein, or investigational drug
* Patients with difficult peripheral intravenous line
* Patients judged to be unsuitable for this trial by investigators

Primary outcomes:
measure: Occurance rate of adverse drug reaction
timeFrame: Day 1 to day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
state: Dalseo-gu
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
state: Dongjak-gu
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
state: Seo-gu
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's Hospital
state: Seocho-Gu
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seongbuk-gu
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Medical Center
state: Suwon-si
Study officials:
References:
Clinical trial NCT03687931: A Clinical Study to Assess the Efficacy and Safety of Dexamethasone Suspension for Cataract Surgery
Official title: A Phase 1/2 Dose-Ranging, Open-Label, Randomized, Clinical Study to Assess the Efficacy and Safety of Dexamethasone Ophthalmic Suspension Eye Drops for the Treatment of Inflammation Associated With Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Inflammation Eye
Lead sponsor: iDrop, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-27
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients at least 40 years of age who are undergoing cataract surgery will be randomized to receive treatment with one of two dose levels of dexamethasone ophthalmic suspension eye drops to determine if the drops decrease inflammation inside the eye and are safe after cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.

Exclusion Criteria:

* Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening.
* Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study.
* Patients who are known steroid responders

Primary outcomes:
measure: Anterior Chamber Cell
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Eye Center
state: Arizona
Study officials:
affiliation: iDrop, Inc.
name: William White
role: STUDY_CHAIR
References:
Clinical trial NCT02655731: HeartLight Guided - Pure Pulmonary Vein Isolation Regardless of Concomitant Atrial Substrate
Official title: HeartLight Guided - Pure Pulmonary Vein Isolation Regardless of Concomitant Atrial Substrate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Cardioangiologisches Centrum Bethanien
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of the present prospective, single-centre study is to determine the outcome after pure PVI using HeartLight™ in 100 patients with different extents of LA-LVA.

The latter will be assessed by an electro-anatomical voltage map using a commercial 3D mapping system (CARTO, Biosense Webster).

Detailed description: The ablation strategy for patients with atrial fibrillation (AF) and concomitant atrial substrate (e.g. low-voltage areas; LVA) is a matter of controversy.

Results of studies investigating the impact of LVA may have been confounded by PV-to-left-atrial (LA) reconnection due to non-durable ablation. Therefore, the true contribution of LA-LVA to AF recurrences remains unknown.

Meanwhile, new ablation technologies such as the HeartLight™ laser balloon (LB) ablation system providing near complete chronic PVI rates have been developed.

Aim of the present prospective, single-centre study is to determine the outcome after pure PVI using HeartLight™ in 100 patients with different extents of LA-LVA.

The latter will be assessed by an electro-anatomical voltage map using a commercial 3D mapping system (CARTO, Biosense Webster).

Eligibility criteria: Inclusion Criteria:

* Symptomatic atrial fibrillation
* Left atrial size \<50mm
* Left ventricular ejection fraction \<45%
* Patient is able to provide informed consent

Exclusion Criteria:

* Contraindications for PVI
* Previous PVI attempts
* Inability to be treated with oral anticoagulation
* Presence of intracardiac thrombi
* Pregnancy
* Participation in other clinical studies
* Unwilling to follow the study protocol and to attend follow-up visits

Primary outcomes:
measure: Freedom from atrial fibrillation and atrial tachyarrhythmias
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt/Main
country: Germany
facility: Cardioangiologisches Centrum Bethanien
Study officials:
affiliation: Cardioangiologisches Centrum Bethanien
name: Boris Schmidt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00610831: Computed Radiography (CR) Data Collection for Mammography Computer Aided Detection (CAD)
Official title: Computed Radiography (CR) Data Collection for Mammography Computer Aided Detection (CAD)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Carestream Health, Inc.
name: Eastman Kodak Company
First posted: 2008-02-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to collect an image library of diagnostic digital mammograms using the Carestream CR mammography system from patients who have histological-conformed breast cancer to demonstrate the clinical feasibility of this system for detection of breast cancer.


Eligibility criteria: Inclusion Requirements

* Women age 40 to 85
* Recommended for biopsy and BI-RADS assessment of category 4 (suspicious abnormality) or 5 (highly suggestive of malignancy)
* Able to have MLO and CC views taken
* Good general health
* Able and willing to provide a written Informed Consent

Exclusion Requirements

* Under age 40
* Pregnant or suspicious of being pregnant
* Breast implants
* Breasts too large to be adequately positioned on a 24 x 30 cassette
* Personal history of breast cancer treated with a lumpectomy
* Unable or unwilling to provide a written Informed Consent form

Primary outcomes:
measure: To collect mammogram from patients with breast cancer using the Carestream Mammo CR device.
timeFrame: at completion of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: Breast Health Center, University of California Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Stephen Feig, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02529631: RCT to Compare Orlistat and Polyglucosamine for the Management of Overweight and Obesity
Official title: Randomized, Double-blind, Clinical Investigation to Compare Orlistat 60 mg and a Customized Polyglucosamine, Two Treatment Methods for the Management of Overweight and Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Polyglucosamine
L 112
overweight,
obesity
orlistat
weight reduction
Lead sponsor: Certmedica International GmbH
Sponsor class: INDUSTRY
First posted: 2015-08-20
Enrollment: 64
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial compares two treatment methods:

1. Orlistat 60 mg to be taken three times daily one capsule; indicated for weight loss in overweight adults. Important is also that it is taken along with a reduced-calorie and low-fat diet.
2. Polyglucosamine tablets to be taken two times daily two tablets, taken with the two main meals with the highest fat content, indicated for weight maintenance and weight loss.


Eligibility criteria: Inclusion Criteria:

* BMI ≥ 28 kg/m² and \< 45 kg/m²
* Waist circumference \> 80 cm (women) \> 94 cm (men)

Exclusion Criteria:

* Energy intake lower than the standard value according to Miffin St-Jeor equation
* Pregnancy or breast-feeding
* Addiction to alcohol
* Inability to fulfil the requirement of the trial protocol
* Cancer ,malignant tumour
* Hypersensitivity reactions to crustaceans or ingredient of the study medication
* Chronic diseases not under control with adequate therapy
* Diabetes

Primary outcomes:
measure: Number of participants in both groups with a weight reduction of >= 5 per cent compared to the initial weight.
timeFrame: 12 weeks
Secondary outcomes:
measure: BMI reduction
timeFrame: 12 weeks
measure: Waist circumference reduction
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Dreieich
country: Germany
facility: Diabetological Center
state: Hesse
city: Rende
country: Italy
facility: MAP Center
state: Cosenza
Study officials:
affiliation: Diabetological centre, Dreieich, Germany
name: Manfred Stoll, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CorCon, Mailand, Italy
name: Umberto Cornelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stoll M, Bitterlich N, Cornelli U. Randomised, double-blind, clinical investigation to compare orlistat 60 milligram and a customized polyglucosamine, two treatment methods for the management of overweight and obesity. BMC Obes. 2017 Jan 11;4:4. doi: 10.1186/s40608-016-0130-4. eCollection 2017.