louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03235375: A Study to Evaluate Pharmacokinetics, Safety and Tolerability of MEDI0382 in Renal Impairment Subjects
Official title: A Phase 1, Open-Label, Single Dose, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of MEDI0382 in Subjects With Renal Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Insufficiency
Keywords: Kidney Failure, Kidney Insufficiency, Renal Failure, Renal Insufficiency, MEDI0382
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2017-08-01
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A phase 1 open-label, single-dose study to evaluate the pharmacokinetics (PK), safety, tolerability and immunogenicity of MEDI0382 in subjects with renal impairment.

Detailed description: This is an open-label, single-dose, parallel group study to evaluate the PK, safety, tolerability, and immunogenicity of MEDI0382 in subjects with renal impairment. Enrollment of approximately 40 subjects across multiple sites is planned. Subjects will be divided into 4 groups based on renal function.

Eligibility criteria: Inclusion Criteria:

* Must provide written informed consent
* BMI greater than or equal to 17 and less than or equal to 40 kg/m2
* Creatinine clearance rate greater than or equal to 90 (healthy); or renally impaired (less than 60 mL/min)
* Females of childbearing potential must use a highly effective form of contraception.

Exclusion Criteria:

* Any history of or concurrent condition that in the opinion of the investigator would compromise the subjects safety.
* Subjects on dialysis
* Subjects with pancreatitis
* Renal transplant subjects
* Females pregnant or lactating

Primary outcomes:
measure: Maximum Observed Concentration of MEDI0382 (Cmax)
timeFrame: 0-48 hours
measure: Area under the Concentration Time Curve (AUC) of MEDI0382
timeFrame: 0-48 hours
Secondary outcomes:
measure: Time to maximum observed concentration (Tmax)
timeFrame: 0-48 hours
measure: apparent clearance (Cl/F)
timeFrame: 0-48 hours
measure: AUCinf
timeFrame: 0-48 hours
measure: Half-life (T1/2)
timeFrame: 0-48 hours
measure: Anti-drug Antibody (ADA) titer
timeFrame: Day -1 to day 28
measure: Number of subjects with Adverse Events
timeFrame: Study onset till 28 days post dosing
measure: Number of subjects with Adverse Events
timeFrame: Study onset till 28 days post dosing
measure: Number of subjects with Adverse Events
timeFrame: Study onset till 28 days post dosing
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Auckland
country: New Zealand
facility: Research Site
city: Christchurch
country: New Zealand
facility: Research Site
Study officials:
References:
Clinical trial NCT02130375: Clinical and Urodynamic Effects of Minimally Laser (IncontiLaseTM) Procedure for Female Stress Urinary Incontinence
Official title: Clinical and Urodynamic Effects of Minimally Laser (IncontiLaseTM) Procedure for Female Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stress Urinary Incontinence
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-05-05
Enrollment: 35
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to get the effect of IncontiLaseTM procedure; and its impact on urinary symptoms and female sexual function.

Detailed description: To get the objective urodynamic and sonographic effects of IncontiLaseTM procedure on women with stress urinary incontinence; and its impact on urinary symptoms and female sexual function.

Eligibility criteria: Inclusion Criteria:

* All consecutive sexually active and parous adult women with the complaint of stress urinary incontinence

Exclusion Criteria:

* \< 20 years old female

Primary outcomes:
measure: The change of pad weight from baseline
timeFrame: 3 months
Secondary outcomes:
measure: The change of maximum urethral closure procedure from baseline
timeFrame: 3 months
Other outcomes:
measure: The change of female sexual functional score from baseline after treatment
timeFrame: 3 months
measure: The change of periurethral blood flow from baseline
timeFrame: 3 months
Locations:
city: Taipei
country: Taiwan
facility: Department of Obstetrics & Gynecology, National Taiwan University Hospital
Study officials:
affiliation: Department of Obstetrics & Gynecology, National Taiwan University Hospital
name: Ho-Hsiung Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05762575: Application of Spaghetti Knotting Technology in Single-hole Laparoscopic Suturing Instructional Program on the Basis of Multidirectional Stitching Technology.
Official title: Application of New Knotting Methods in Single-hole Laparoscopic Suturing Instructional Program on the Basis of Multidirectional Stitching Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knotting Methods
Single-port Laparoscopic Surgery
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the candidates were junior residents. Forty volunteers were selected according to the established criteria and randomly divided into control group and experimental group by computer-generated simple randomization. There were twenty volunteers in each group, and each group was composed of five males and fifteen females. The volunteers in control group study traditional knotting technology, and the volunteers in experimental group study new knotting technology. A statistician in our hospital completed the random distribution of the subjects and ensured the confidentiality of the grouping information. Before participating in the study, the subjects completed a questionnaire about their demographic information, such as age, gender and experience in video games.

Brief summary: The surgeon's knot-tying technique plays a crucial role in the recovery of patients after single-port laparoscopy. Knot tying is very challenging in minimally invasive surgery and is a critical skill in advanced surgery. In this study, investigators introduce a new knotting technique, compare it with the traditional knotting technique in many aspects, and also discuss its application in the teaching of single-port laparoscopic knotting.


Eligibility criteria: Inclusion Criteria:

1. the habitual hand is the right hand;
2. no practical experience in operating single-hole laparoscopic instruments;
3. no simulator sickness;
4. training and assessment are completed on time and carefully

Exclusion Criteria:

1. have participated in other skills training programs
2. are not interested in single-hole laparoscopy will be excluded

Primary outcomes:
measure: Accuracy of needle entry
timeFrame: through study completion, an average of 1 month
measure: Stability of the knot
timeFrame: through study completion, an average of 1 month
measure: Tissue integrity
timeFrame: through study completion, an average of 1 month
measure: Tightness of the tissue
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Zhejiang
country: China
facility: The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Study officials:
References:
Clinical trial NCT02855775: Monoclonal Antibodies Elimination in Breast Cancer Patient
Official title: Study of the Relative Impact of the Neonatal Fc Receptor (FcRn) and the Therapeutic History on Monoclonal Antibodies Elimination. Proof of the Concept on Patients Treated by Bevacizumab or Trastuzumab in Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This Study evaluates covariables being able to potentially influence the elimination of the monoclonal antibodies (trastuzumab, bevacizumab and denosumab).

Detailed description: Monoclonal antibodies are very widely used in cancer treatment . Certain patients benefit from these antibodies for several years and it is conceivable to wonder about the evolution of the pharmacokinetics of these antibodies.

Eligibility criteria: Inclusion Criteria:

* A diagnosed cancer
* patient treated by bevacizumab or trastuzumab
* Life expectancy of at least 3 months
* For the women: menopausal women for at least 24 months, sterilized surgically, or, for the women old enough to procreate, use a method of effective contraception (oral contraceptives, contraceptive injections, intra-uterine devices, method of the double barrier, the contraceptive patches). This contraception will have to be pursued during 6 months after the end of the treatment by bevacizumab or by trastuzumab.

Exclusion Criteria:

* For Patients treated by trastuzumab: Dyspnoea of severe rest in touch with complications due to the disease or requiring an oxygen therapy.
* Hypocalcemia severe untreated

Primary outcomes:
measure: clearance of the bevacizumab
timeFrame: 9 months
Secondary outcomes:
measure: clearance of the trastuzumab
timeFrame: 9 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire
Study officials:
References:
Clinical trial NCT05094375: Vaginal Misoprostol In Medical Treatment of First Trimester Missed Miscarriage
Official title: Vaginal Misoprostol 600 mcg and 800 mcg In Medical Treatment of First Trimester Missed Miscarriage: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Miscarriage
Keywords: miscarriage
vaginal
misoprostol
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a double-blinded randomized trial
Primary purpose: TREATMENT

Brief summary: Efficacy of vaginal misoprostol 600 Mg versus 800 Mg in termination of the first trimester missed abortion were assist

Detailed description: In women with first trimetric-missed miscarriage, vaginal misoprostol in the achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal misoprostol 600 Mg versus 800 Mg for medical treatment of the first trimester missed miscarriage.

Eligibility criteria: Inclusion Criteria:

* All women above 18 years of age
* Less than 12 weeks of gestation.
* Pregnancy is confirmed by pregnancy test or ultrasound scan.
* missed abortion
* Normal general and gynecological examination.

Exclusion Criteria:

* Hemodynamically unstable.
* Suspected sepsis with temperature 38 °C.
* Concurrent medical illness e.g. hematological, cardiovascular, thromboembolism,
* respiratory , recent liver disease, or pruritus of pregnancy.
* Presence of intrauterine contraceptive device (IUCD).
* Suspect or proven ectopic pregnancy.
* Failed medical or surgical evacuation before the presentation.
* Known allergy to misoprostol.

Primary outcomes:
measure: Completeness of abortion
timeFrame: 7 days
Secondary outcomes:
measure: Successful medical abortion
timeFrame: 14 days
measure: Bleeding pattern following treatment
timeFrame: 7 days
measure: Pain resulting from the procedure
timeFrame: 7 days
measure: Additional uterotonic used
timeFrame: 14 days
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
References:
Clinical trial NCT01490775: Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Niltinib) Therapy
Official title: Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Nilotinib)Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Phase CML
Keywords: Chronic Myeloid Leukemia
Lead sponsor: Rex Cancer Center, Raleigh, NC
Sponsor class: OTHER
Collaborators: name: Northwestern University
First posted: 2011-12-13
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is being conducted in a population of patients with chronic phase Chronic Myeloid Leukemia (CML) to learn more about how patients follow prescribed regimens for taking oral cancer drugs.

Detailed description: This is a randomized, controlled pilot study to introduce eMedonline telemonitoring technology to CML patients taking Gleevec or Tasigna. eMedonline will be used to automatically collect time-dose specific medication data for individual patients, including dosing times, missed doses, adverse events and e-diary data. All data will be available to research staff for remote review via Web interface. Adverse events and non-adherence will prompt interventions including supportive care counseling.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older.
* Pathologically documented diagnosis of Chronic Phase CML (Ph+) in whom treating physician has determined that treatment with imatinib or nilotinib is appropriate
* Patients currently receiving Gleevec (imatinib) 300-600 mg daily or Tasigna (nilotinib) 300-400 mg twice daily
* Known performance status 0,1 or 2 (ECOG)
* Known adequate end organ function, defined as:

Total bilirubin \< 1.5 xULN SGOT and SGPT \<2.5 x ULN ANC \> 1.5 Platlets \> 100,000

* Patient is willing and able to use a cell phone
* Written, voluntary informed consent

Exclusion Criteria:

* Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent

Primary outcomes:
measure: eMedonline will be used to measure non-compliance in taking oral drug regimens.
timeFrame: at 6 months, non-compliance will be measured in each arm of study
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Raleigh
country: United States
facility: Rex Cancer Center - Wakefield
state: North Carolina
Study officials:
affiliation: Rex Cancer Center - Wakefield
name: Robert Wehbie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05535959: A Study to Evaluate the Relative Bioavailability of a Fixed-dose Combination Tablet of VX-121/Tezacaftor/Deutivacaftor
Official title: A Phase 1, Randomized, Open-label, Crossover Study to Evaluate the Relative Bioavailability of a Fixed-dose Combination Tablet of VX-121, Tezacaftor, and Deutivacaftor in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2022-09-10
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the relative bioavailability of a fixed-dose combination tablet (FDC) of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA).

Detailed description: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility criteria: Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m\^2), both inclusive
* A total body weight greater than (\>)50 kg

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption
* Female participants who are pregnant, nursing, or planning to become pregnant during the study or 90 days after the last dose of the study drug
* Male participants with a female partner who is pregnant, nursing, or planning to become pregnant during the study
* History of cardiovascular disease or central nervous system disease

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of VX-121, TEZ, and D-IVA
timeFrame: Pre-dose up to 288 hours Post-dose
measure: Area Under the Concentration Versus Time Curve (AUC) of VX-121, TEZ, and D-IVA
timeFrame: Pre-dose up to 288 hours Post-dose
Secondary outcomes:
measure: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 up to Day 28
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: ICON Salt Lake City
state: Utah
Study officials:
References:
Clinical trial NCT05364359: Individual Dietary Counseling Based on Taste-tests in Patients With Hematological Cancer in Cytostatic Therapy
Official title: Individuel diætvejledning på Baggrund af Smagstest Hos Patienter Med hæmatologisk Cancer i Cytostatisk Behandling
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hematological Malignancy
Keywords: cancer
hematological
malignancy
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Zealand University Hospital
First posted: 2022-05-06
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to investigate whether a simple taste-test will increase the intake of energy as part of the individual dietary counseling.

Detailed description: The investigators will investigate the tastes (umami, bitter, salty, sweet and sour) that the patients prefers in order to increase the energy intake and reduce the risk of weight loss and loss of fat-free mass for patients with hematological cancer.

The study will be conducted as a single blinded randomized controlled trial. 40 patients will be recruited, and will be divided into two groups; the intervention group and the control group. The patients will not know which group they belong to.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Able to understand the "Participant Information" paper
* Diagnosed with hematological cancer
* Must be undergoing chemotherapy (at least one treatment during the study)
* Outpatient
* Be able to take pictures of meals (and send to the sub-investigators)
* Be able to speak and read the danish language

Exclusion Criteria:

* Pacemaker

Primary outcomes:
measure: Consumption of energy as a percentage of estimated need
timeFrame: 6 weeks
Secondary outcomes:
measure: Fat-free-mass and fat-mass in percent (bioimpedance measurement)
timeFrame: 6 weeks
measure: Satisfaction (measured with EROTC QLQ-C30 version 3.0)
timeFrame: 6 weeks
measure: Hand-grip-strength (measured with a dynamometer)
timeFrame: 6 weeks
measure: Body weight
timeFrame: 6 weeks
measure: Protein intake
timeFrame: 6 weeks
measure: Burning/pain in the mouth (measured on a scale)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Department of Hematology
Study officials:
References:
Clinical trial NCT01572259: Assessment of the Role of the Growth Hormone (GH) Onthe Intestinal Triglyceride-rich-lipoproteins (TRL) Metabolism
Official title: Assessment of the Role of the Growth Hormone (GH) Onthe Intestinal Triglyceride-rich-lipoproteins (TRL) Metabolism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Atherosclerotic Cardiovascular Disease
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2012-04-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: Atherosclerotic cardiovascular disease (ASCD) is the first cause of morbidity and mortality in insulin resistant states. The typical dyslipidemia that is associated with insulin resistance, which includes a postprandial increase of triglyceride-rich lipoproteins (TRL) with excess of intestinal triglyceride-rich-lipoprotein-apoB-48 (TRL-apoB-48), is felt to play an important role in the accelerated ASCD. Recently, intestinal TRL-apoB-48 overproduction appeared as a newly recognized component of insulin resistance. There is only a limited amount of information in the literature regarding the factors and the mechanisms modulating the metabolism of intestinal TRL-apoB-48 in the setting of insulin resistance


Eligibility criteria: Inclusion Criteria:

Male or feminine

* age from 18 to 70 years
* deficit in growth hormone informed by a peak lower than 10 mUI / l in answer to a test of hypoglycemia (or another test of stimulation if the hypoglycemia insulinique is dissuaded) (cf. attached the RCP of various growth hormone used at the adult)
* centre (treatments optimized previously will be maintained during all the duration of the study) thyréotrope, corticotrope and gonadotrope substituted well for at least 6 months
* IMC(CEREBRAL-MOTOR HANDICAPPED) \< 30 kg / m2
* fasting blood glucose \< 1,26 g/L
* clearance of the creatinine \> 60 ml / min

Exclusion Criteria:

Nobody particularly protected: incapable major and private person of freedom, person hospitalized for another pathology; · nobody mastering the reading of the French language

* carrier patients of a tumor in service
* pregnant woman

Primary outcomes:
measure: To measure of Growth hormone
timeFrame: 3 YEARS
Secondary outcomes:
measure: to measure the adipocytokines levels (leptin, adiponectin, resistin) the metabolism (production and/or clearance) of the intestinal TRL
timeFrame: 3 YEARS
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique hôpitaux de Marseille
name: BERNARD BELAIGUES
role: STUDY_DIRECTOR
References:
citation: Maraninchi M, Calabrese A, Nogueira JP, Castinetti F, Mancini J, Mourre F, Pietri L, Benamo E, Albarel F, Morange I, Dupont-Roussel J, Nicolay A, Brue T, Beliard S, Valero R. Role of growth hormone in hepatic and intestinal triglyceride-rich lipoprotein metabolism. J Clin Lipidol. 2021 Sep-Oct;15(5):712-723. doi: 10.1016/j.jacl.2021.08.003. Epub 2021 Aug 16.