louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01017302: A Study With RO5095932 in Patients With Type 2 Diabetes on Stable Metformin Therapy.
Official title: A Randomized, Double-blind, Placebo-controlled, Titration Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose and Escalating Doses of RO5095932 in Patients With Type 2 Diabetes Mellitus on Stable Background Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-11-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in adult patients with type 2 diabetes mellitus. Patients that are on stable metformin therapy are eligible to enter the study. There will be a 5-weeks exenatide run in period and a 5-weeks period when co-administered with the study drug. RO5095932 will be administered subcutaneously as a single dose or as escalating doses. Patients will be randomized to receive either active drug or placebo in weeks 1 to 4. Active drug or placebo will be administered once weekly for 4 weeks. Patients who received active drug in weeks 1 to 4 will receive placebo in week 5. Patients who received a single dose of placebo in weeks 1 to 4, will receive a single dose of active drug in week 5. The anticipated time of study treatment is \<6 months. The target sample size is \<100 patients.


Eligibility criteria: Inclusion Criteria:

* Adult patients, 18-65 years of age
* Diabetes mellitus, type 2 for at least 6 months before screening
* On treatment with stable doses of metformin for at least 3 months before screening
* BMI between \>/=25 and \</=39

Exclusion Criteria:

* Type 1 diabetes
* Pancreatitis
* Treatment with insulin for more than one week within 3 months prior to study start

Primary outcomes:
measure: Safety and Tolerability of various doses of RO5095932
timeFrame: Weeks 1-4, 6, 8
Secondary outcomes:
measure: Safety and Tolerability of a single dose of RO5095932
timeFrame: Week 5, 6, 8
measure: Pharmacokinetics: blood concentration
timeFrame: Weeks 1-4, 6, 8
measure: Pharmacodynamics: glucose, insulin, C-peptide
timeFrame: Weeks 1-4, 6, 8
Other outcomes:
Locations:
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02843802: Combination of Cryosurgery and NK Immunotherapy for Advanced Liver Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Secondary Malignant Neoplasm of Liver
Keywords: Metastatic liver cancer
Cryosurgery
NK Immunotherapy
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shenzhen Hank Bioengineering Institute
First posted: 2016-07-26
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to advanced liver cancer.

Detailed description: By enrolling patients with liver cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and nature killer (NK) cells for advanced liver cancer.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Institute in Fuda cancer hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT00464802: Study Evaluating the Safety and Tolerability of a New Intravenous Formulation of MOA-728 in Healthy Subjects
Official title: A Double-Blind, Placebo-Controlled, Multiple-Dose, 2-Period Crossover Study to Evaluate the Safety and Tolerability of a New Intravenous Formulation of MOA-728 in Comparison With the Current Formulation in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy
safety
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2007-04-24
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective is to determine the safety and tolerability of the new IV formulation versus the current formulation of MOA-728 focusing on the theoretical potential for infusion-related and formulation-related complications.


Eligibility criteria: * A signed and dated informed consent form.
* Men or nonlactating and nonpregnant women, aged 18 to 80 years, inclusive.
* Women of nonchildbearing potential (WONCBP) must be surgically sterile (hysterectomy, oophorectomy, and/or tubal ligation) or postmenopausal for ³1 year.
* Women of childbearing potential (WOCBP) must be using an acceptable nonhormonal method of contraception (intrauterine device \[IUD\], diaphragm, or condom with spermicidal jelly or foam, abstinence) for a period of at least 1 month before and after dose administration.
* All women must have a negative pregnancy test result within 48 hours before the start of the first test article administration.
* Body mass index in the range of 18 to 32 kg/m² and body weight ≥50 kg.
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).
* Subjects aged 65 to 80 years should be healthy, but may be enrolled with a chronic illness, if such illness is well controlled and does not interfere with the primary objective of the study. Certain concomitant medications will be allowed for the treatment of these conditions and are listed in the Concomitant Treatment section.
* Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking from 48 hours before and throughout the inpatient stay.
* Have a high probability for compliance with and completion the study.

Primary outcomes:
measure: IV site tolerability and urinary zinc excretion
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Jeff Cohn
role: STUDY_DIRECTOR
References:
Clinical trial NCT06767202: Relationship Between Exposure to Phenols and Pregnancy Outcomes After Embryo Transfer
Official title: Relationship Between Exposure to Phenols and Pregnancy Outcomes After Embryo Transfer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Embryo Transfer
Keywords: Embryo Transfer
Dietary polyphenols
bisphenols
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women undergoing assisted reproductive technology in Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China from 2024 to 2025

Brief summary: The goal of this observational study is to explore the association between phenol exposure and pregnancy outcome after embryo transfer. The main question it aims to answer \[is/are\]:

Whether exposure to phenols is associated with adverse pregnancy outcomes in pregnant women undergoing assisted reproductive technology?

Detailed description: First of all, paper questionnaires were used in this study, including general information questionnaire, health effect questionnaire, health survey summary form, and dietary assessment questionnaire. Secondly, obtain the relevant information of the medical record system, including: assisted reproduction protocol, IVF examination results, B-ultrasound examination results, laboratory test indicators, pregnancy outcome information and newborn information. Finally, urine samples were detected using a high performance liquid chromatography mass spectrometer.

Eligibility criteria: Inclusion Criteria:

1. Chinese citizens over the age of 20;
2. IVF/ICSI assisted reproductive treatment in our center;
3. Complete clinical data, reproductive outcomes and questionnaire data of both sexes;
4. Knowing about this research and voluntarily accepting this research;

Exclusion Criteria:

1. The patient receives sperm or egg donation treatment;
2. The patient gave up the egg collection operation due to various reasons, and the cycle was canceled;
3. The patient abandons treatment before achieving clinical pregnancy, but the fertile frozen embryo is not transferred;
4. There are contraindications to pregnancy, such as serious liver and kidney diseases, malignant tumors, serious mental diseases, uncorrected coagulation function abnormalities or endocrine indicators abnormalities;
5. Incomplete or missing clinical data or follow-up data;

Primary outcomes:
measure: Rate of clinical pregnancy patients
timeFrame: From the date of randomization until the termination of pregnancy
Secondary outcomes:
measure: Rate of the health newborn
timeFrame: From the date of randomization until the termination of pregnancy
Other outcomes:
Locations:
city: WuHan
country: China
facility: Reproductive center，tongji hospital，huazhong university of science and technology
state: Hubei
Study officials:
References:
Clinical trial NCT01629602: Treatment of Soft Tissue Loss With Nerve Defect in the Finger Using the Boomerang Nerve Flap
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Tissue Loss With Nerve Defect
Keywords: defect;
dorsal branch of the proper digital nerve;
proper digital nerve;
vascularized nerve graft
Lead sponsor: The Second Hospital of Tangshan
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
First posted: 2012-06-27
Enrollment: 49
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Soft tissue loss with proper digital nerve (PDN) defect in the finger results in sensory loss of the finger pulp. Reconstruction of these complex soft tissue defects continues to be a challenge problem. To resolve this problem, we combined the nerve branch with the boomerang flap for simultaneous repair of soft tissue loss and PDN defect in these awkward areas. For comparison, we also collected a consecutive series of 32 patients with similar injury in the finger treated using a cross finger flap and a secondary free nerve graft.

Detailed description: The patients in this study group were required to meet all of the following criteria: soft tissue loss between the midpoint of the distal phalanx and PIP joint; associated PDN defect 1 to 4 cm in length; single or double PDN defects; and simultaneous repair of soft tissue loss and PDN defect. Patients were excluded when they had the following: injury to the course of the vascular pedicle or the donor site or the donor nerve; PDN defect less than 1 cm or larger than 4 cm in length; direct PDN repair; and thumb neurocutaneous defects.

Eligibility criteria: Inclusion Criteria:

* soft tissue loss between the midpoint of the distal phalanx and PIP joint; - associated PDN defect 1 to 4 cm in length;
* single or double PDN defects;
* simultaneous repair of soft tissue loss and PDN defect.

Exclusion Criteria:

* injury to the course of the vascular pedicle or the donor nerve;
* PDN defect less than 1 cm or larger than 4 cm in length;
* direct PDN repair;
* thumb neurocutaneous defects.

Primary outcomes:
measure: static 2-point discrimination test
timeFrame: from 18 to 24 months
Secondary outcomes:
measure: Cold Intolerance Severity Score (CISS) questionnaire
timeFrame: from 18 to 24 months
Other outcomes:
Locations:
Study officials:
References:
citation: Chen C, Tang P, Zhang X. Treatment of soft-tissue loss with nerve defect in the finger using the boomerang nerve flap. Plast Reconstr Surg. 2013 Jan;131(1):44e-54e. doi: 10.1097/PRS.0b013e3182729f5e.
Clinical trial NCT02394002: SEP Changes During Deep Anesthesia
Official title: The Effect of Burst-suppression-pattern in EEG on Generating Somatosensory Evoked Potentials
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Somatosensory Evoked Potentials, and Electroencephalography
Keywords: EEG, burst-suppression, N20, SEP, median nerve, facilitation
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: Department of Anaesthesiology, Heinrich Heine University
name: Department of Anesthesiology, Helios Klinikukm Wuppertal
First posted: 2015-03-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The relation between burst and suppression periods in transcranial and direct cortical recorded EEG with cortical amplitudes median nerve somatosensory evoked potentials is studied.

60 patients are included in this study: 15 patients undergoing brain tumor surgery, 15 spine surgery (University Hospital Düsseldorf) and 30 patients during general surgical procedures (Helios Klinikum Wuppertal).


Eligibility criteria: Inclusion Criteria:

* Location Helios Klinikum Wuppertal: neurological healthy patients, which undergo an elective surgery under general anaesthesia
* Location Department of Neurosurgery, University Hospital Düsseldorf: all patients with intracranial interventions and the possibility to place a stripe electrode without complications on cortex (it is decided by the surgeon while surgery because of the situs and tumorlocation)

Exclusion Criteria:

* periodical consumption of drugs and pharmaceuticals which influence cortical excitability
* intraoperative contraindication for required depth of anaesthesia
* neurological pre-existing illness
* advanced hepatic insufficiency

Primary outcomes:
measure: SEP ampiltude in burst-suppression-EEG
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Neurosurgical Clinic
Study officials:
affiliation: Neurosurgical Clinic, Heinrich Heine University
name: Andrea Szelényi, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00762502: Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period
Official title: Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To evaluate two toric contact lenses on the ocular physiology of existing contact lens wearers when used in an extended wear modality of days/six nights.


Eligibility criteria: Inclusion Criteria:

* Able to wear study lenses in parameters available
* Non-presbyopes between the ages of 18-45
* Understand and sign informed consent
* Willing to follow the protocol
* Achieve at least 20/30 (6/9) visual acuity (VA) in right eye (OD) and left eye (OS) with study lenses
* Myopia -0.75 to -6.25, cylinder -0.75 to -1.50 diopters (D) (axis 90 +/- 15, 180 +/- 15) or -1.75 D (axis 90 +/- 10, 180 +/- 10)
* Adapted soft contact lens wearer
* Swims no more than once a week
* Has a wearable pair of spectacles.

Exclusion Criteria:

* Any ocular or systemic disorder which may contraindicate contact lens wear
* Any topical ocular medication
* Aphakic
* Corneal refractive surgery
* Corneal distortion from hard CL wear or keratoconus
* Pregnant or lactating
* Grade 2 or worse slit lamp signs
* Infectious disease
* Previous clinical study within 2 weeks
* Don't agree to participate
* Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in last 8 weeks
* Previous adverse effects that contraindicate extended lens wear.
* Self-reported symptoms of itchiness or scratchiness with habitual lenses.

Primary outcomes:
measure: Corneal Staining
timeFrame: at 3 months of lens wear (period 1)
measure: Limbal Redness
timeFrame: at 3 months of lens wear (period 1)
measure: Bulbar Redness
timeFrame: at 3 months of lens wear (period 1)
measure: Tarsal Roughness
timeFrame: at 3 months of lens wear (period 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
state: Massachusetts
city: Newtown
country: Australia
state: New South Wales
city: Camberwell
country: Australia
state: Victoria
city: Hawthorn
country: Australia
state: Victoria
city: Keilor
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Mitcham
country: Australia
state: Victoria
city: Moe
country: Australia
state: Victoria
Study officials:
References:
Clinical trial NCT00223002: Chlorhexidine Versus Povidone-Iodine for Prevention of Epidural Needle Contamination in the Parturient
Official title: Chlorhexidine Versus Povidone-Iodine for Prevention of Epidural Needle Contamination in the Parturient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asepsis
Analgesia, Epidural
Anesthesia, Epidural
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Infection after epidural catheter placement is fortunately rare. When it does happen, the affected person can become seriously ill.

This study examines which skin disinfectant, chlorhexidine or povidone-iodine, decreases the number of bacteria that can be grown from the skin washed with each disinfectant prior to placing an epidural catheter for pain control in labour.

Detailed description: The use of chlorhexidine for skin asepsis for the placement of intravascular catheters is known to decrease the incidence of central line colonization and blood stream infection when compared to the use of povidone-iodine. While the development of an infectious complication following spinal or epidural analgesia, such as epidural abscess or meningitis, is fortunately rare, when it does happen, there can be devastating consequences for the affected individual. The low frequency of infection makes a trial with an endpoint of clinical infection not feasible, however a reduction in skin and needle contamination following attempts at asepsis should reduce the risk of infectious complication. Ongoing work by the authors is examining the skin culture rates following randomized standardized skin disinfection. The purpose of this randomized trial is to compare needle culture rates to further assess effectiveness of skin disinfection following a standardized skin preparation with either povidone-iodine or chlorhexidine in pregnant women requesting lumbar epidural pain relief in labour.

Eligibility criteria: Inclusion Criteria:

* Parturients requesting lumbar labour epidural analgesia while investigator is assigned to the Obstetrical Anesthesia Service

Exclusion Criteria:

* Known allergy to either skin disinfectant
* Requirement to receive antibiotics prior to placement of lumbar epidural catheter
* Immunosuppression of the participant

Primary outcomes:
measure: culture-positive rate of epidural needles processed by microbiology lab
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan College of Medicine
name: Susan A Shaw, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01242202: A Study to Assess the Safety and Efficacy of ASP1941 in Combination With α-glucosidase Inhibitor in Type 2 Diabetic Patients
Official title: Phase III Study of ASP1941 - Open-label, Non-comparative Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Combination With an α-Glucosidase Inhibitor in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With an α-Glucosidase Inhibitor Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes mellitus
alpha glucosidase inhibitor
ASP1941
long-term safety
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-11-16
Enrollment: 113
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate long-term safety and efficacy after concomitant administration of ASP1941 and α-glucosidase inhibitor in Japanese patients with type 2 diabetes mellitus.

Detailed description: This is a 52-week multi-center study in subjects with type 2 diabetes mellitus who have inadequate glycemic control on an α-Glucosidase Inhibitor alone. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic patients receiving with α-glucosidase inhibitor mono-therapy for at least 4 weeks
* HbA1c value between 6.5 and 9.5%
* Body Mass Index (BMI) 20.0 - 45.0 kg/m2

Exclusion Criteria:

* Type 1 diabetes mellitus patients
* Serum creatinine \> upper limit of normal
* Proteinuria (albumin/creatinine ratio \> 300mg/g)
* Dysuria and/or urinary tract infection, genital infection
* Significant renal, hepatic or cardiovascular diseases
* Severe gastrointestinal diseases

Primary outcomes:
measure: Change from baseline in HbA1c
timeFrame: baseline and 52 weeks
Secondary outcomes:
measure: Change from baseline in fasting plasma glucose
timeFrame: baseline and 52 weeks
measure: Change from baseline in fasting serum insulin
timeFrame: baseline and 52 weeks
measure: Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)
timeFrame: for 52 weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyushu
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References: