louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04581720: Minimum Current for Train-of-four Monitoring
Official title: Determination of the Minimum Current for Train-of-four Monitoring by Acceleromyography and Electromyography During the Recovery From General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Anesthesia Recovery Period
Neuromuscular Blockade
Lead sponsor: Ewha Womans University Mokdong Hospital
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Neuromuscular monitoring during general anesthesia is important to make sure adequate muscle relaxation during operation and adequate recovery of muscle power and spontaneous breathing during emergence from general anesthesia. The neuromuscular monitoring is usually using electrical stimulants and the method called train-of-four (TOF) is representative. Because it uses electrical stimulants, the patients could be uncomfortable and feel pain during the monitoring when the patients are conscious. Lowering the current of the stimulants would be helpful in reducing the pain, but there is a concern that the TOF results performed in lower current would be underestimated or inaccurate. Therefore, the investigators want to find the minimal current for TOF monitoring that shows adequate TOF results.


Eligibility criteria: Inclusion Criteria:

* Age 20-65
* Scheduled for an elective surgery
* ASA physical status 1 or 2

Exclusion Criteria:

* BMI \> 25 kg/m2
* Neuromuscular disease
* Decreased renal function
* Neurologic disorder
* Impossible to cooperate or communicate

Primary outcomes:
measure: Minimal current for TOF
timeFrame: During the operation, from the height of T1 reaches back to the baseline, to the extubation of tracheal tube when the general anesthesia is over.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
Study officials:
References:
Clinical trial NCT01212120: The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections
Official title: The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot
Staphylococcus Aureus
Keywords: Diabetic foot
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2010-09-30
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult type 1 or 2 diabetic patients with grade 2-4 foot or ankle ulcers (first event or recurrence)

Brief summary: The presence of S aureus in the nasal passages of diabetic patients may be a risk factor for diabetic foot lesion infections. Our aim is to compare the genetic profiles of S aureus strains found in the noses and on the foot lesions of diabetic patients. The investigators are also studying the virulence of these strains, the prevalance of S aureus at either site, and whether or not the quantity of S aureus found in the nose affects the risk for infection in foot lesions. The investigators also use this study to test the sensitivity and specificity of the GeneXpert system.


Eligibility criteria: Inclusion Criteria:

* Type 1 or 2 diabetic patients
* Patients consulting or hospitalized in the Diabetology departments of one of the participating centers
* Grade 2-4 ulcer on the foot or ankle (both primo and recurrent events are acceptable)

Exclusion Criteria:

* Patient refuses to participate
* Pregnant, parturient or breastfeeding women
* Patient does not have diabetic foot or arteritic
* Diabetic ulcer is located elsewhere than the foot or ankle
* The ulcer is non-swabbable
* Patient does not have social-security coverage
* Patient is under any type of guardianship

Primary outcomes:
measure: Presence/absence of the same S. aureus genetic profile in the nose and on the foot lesion.
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Nimes
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
state: Gard
city: Le Grau du Roi
country: France
facility: CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
city: Marseille
country: France
facility: APHM - Hôpital Nord
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Lapeyronie
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Jean-Philippe Lavigne, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02248220: Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's Disease
Official title: Observation of the Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-25
Enrollment: 657
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced idiopathic Parkinson's diease recruited at specialist practices and hospitals

Brief summary: Assessment of daily maintenance dose of Sifrol®, L-dopa sparing effect, effect on tremor, depression, anhedonia and tolerability


Eligibility criteria: Inclusion Criteria:

* Patients with advanced idiopathic Parkinson's disease for whom combined treatment with Sifrol and L-dopa was indicated

Exclusion Criteria:

* NA

Primary outcomes:
measure: Change in cumulative daily doses of Sifrol®
timeFrame: up to 8 weeks
measure: Changes in cumulative daily doses of L-dopa
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Change from Baseline in Short Parkinson Evaluation Scale (SPES) total score
timeFrame: Baseline, after 8 weeks
measure: Change from Baseline in SPES subscales
timeFrame: Baseline, after 8 weeks
measure: Change from Baseline in Snaith-Hamilton-Pleasure-Scale total score
timeFrame: Baseline, after 8 weeks
measure: Change from Baseline in Tremor Impact Scale (TIS-D) total score
timeFrame: Baseline, after 8 weeks
measure: Change from Baseline in global Parkinson's Disease (PD) symptoms
timeFrame: Baseline, after 8 weeks
measure: Global assessment of efficacy by investigator on a 5-point scale
timeFrame: after 8 weeks
measure: Global assessment of tolerability by investigator on a 5-point scale
timeFrame: after 8 weeks
measure: Number of patients with adverse events
timeFrame: up to 8 weeks
measure: Number of patients with adverse drug reactions
timeFrame: up to 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04655820: Maternal and Infant Health and Breast Milk Study in South China
Official title: Maternal and Infant Health and Breast Milk Study in South China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 400
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women and breast-feeding mothers of this study were recruited from Clifford Hospital during the perinatal period or lactation period

Brief summary: The purpose of this study was to investigate the nutrients in breast milk of Chinese mothers and its related factors, as well as exploring the early development of infants.

Detailed description: Breast milk contains a variety of nutrients that are beneficial to the early development of infants, such as lipids, Vitamins and so on. At present, the level of these nutrients in milk and infant formula are lower and which are present in a different form from that in breast milk. Therefore, this study was designed to investigate the level of nutrients in breast milk of Chinese mothers and learn about its related factors, as well as exploring the relationships between these nutrients and the early development of infants.

Eligibility criteria: Inclusion Criteria:

* age 20-45 years
* natural delivery, singleton pregnancy
* healthy term infants（at 37-42 weeks of pregnancy）
* don't smoke and drink
* self-evaluation as physical health
* breastfeeding at least until three months of age
* Apgar score \> 8
* sign informed consent

Exclusion Criteria:

* suffering from mastitis
* gestational diabetes, hypertension and other metabolic diseases
* AIDS, tuberculosis and other acute or chronic infectious diseases
* severe heart and kidney diseases
* mental system diseases
* cancer and other malignant consumptive disease
* take drugs that affect nutrient metabolism
* infants with congenital and genetic diseases
* with lactation contraindications
* don't agree to sign informed consent

Primary outcomes:
measure: The level of nutrients in breast milk samples
timeFrame: 14 months
measure: The level of nutrients in blood samples
timeFrame: 14 months
Secondary outcomes:
measure: General demographic materials
timeFrame: 14 months
measure: Dietary and lifestyle information
timeFrame: 14 months
measure: Health follow-up
timeFrame: 14 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: SunYat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT01725620: Study to Compare the Safety and Pharmacokinetic Characteristics of LBEC0101 25mg With Those of Enbrel®
Official title: A Randomized, Double-blind, Single-dosing, 2-way Cross-over Study to Compate the Safety and Pharmacokinetic Characteristics of LBEC0101(Etanercept) 25mg With Those of Enbrel® 25mg After Subcutaneous Injection in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2012-11-14
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the pharmacokinetic characteristic of LBEC0101 25mg with active comparator, Enbrel® 25mg.


Eligibility criteria: Inclusion Criteria:

* Healthy males, 20 to 45 years of age the moment of screening
* Body mass index is between 18.0 and 30.0 kg/m

Exclusion Criteria:

* The tuberculosis patient of latent tuberculosis patient
* Hypersensitivity response to the test and comparator drugs

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital, Clinical Trial Center
Study officials:
affiliation: Seoul National University College of Medicine and Hospitaal
name: Kyung-Sang Yu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee H, Chung H, Lee S, Lee H, Yang SM, Yoon SH, Cho JY, Jang IJ, Yu KS. LBEC0101, A Proposed Etanercept Biosimilar: Pharmacokinetics, Immunogenicity, and Tolerability Profiles Compared with a Reference Biologic Product in Healthy Male Subjects. BioDrugs. 2017 Aug;31(4):349-355. doi: 10.1007/s40259-017-0230-9.
Clinical trial NCT01629420: A Phase II Randomized Open Label Study of KLH-2109 in Patients With Endometriosis
Official title: A Multicenter, Randomized, Open Label Phase II Study of KLH-2109 in Patients With Endometriosis(3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Keywords: Gonadotropin-Releasing Hormone (GnRH) antagonist
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-06-27
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis.


Eligibility criteria: Inclusion Criteria:

* Female patients with endometriosis

Exclusion Criteria:

* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Primary outcomes:
measure: The severity score of the pelvic pain
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo and Other Japanese City
country: Japan
facility: Japan
Study officials:
References:
Clinical trial NCT01612520: Telecoaching of People With Type 2 Diabetes in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Telenursing
Keywords: type 2 Diabetes Mellitus
telenursing
RCT
economic analysis
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2012-06-06
Enrollment: 574
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of the study is to analyze the effectiveness and the cost-effectiveness of telecoching in improving glyceamic control and other modifiable risk factors in patients with type 2 diabetes compared to usual care only.


Eligibility criteria: Inclusion Criteria:

* patients with type 2 diabetes between 18 and 75 years old on the day of the selection

Exclusion Criteria:

* Debilitating coexisting medical condition (e.g. dialysis, mental illness, cancer)
* Residents of long term care facilities
* Pregnancy
* Incapable of telephone communication in Dutch

Primary outcomes:
measure: the absolute change in HbA1c
timeFrame: baseline; 6 months and 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Odnoletkova I, Buysse H, Nobels F, Goderis G, Aertgeerts B, Annemans L, Ramaekers D. Patient and provider acceptance of telecoaching in type 2 diabetes: a mixed-method study embedded in a randomised clinical trial. BMC Med Inform Decis Mak. 2016 Nov 9;16(1):142. doi: 10.1186/s12911-016-0383-3.
citation: Odnoletkova I, Ramaekers D, Nobels F, Goderis G, Aertgeerts B, Annemans L. Delivering Diabetes Education through Nurse-Led Telecoaching. Cost-Effectiveness Analysis. PLoS One. 2016 Oct 11;11(10):e0163997. doi: 10.1371/journal.pone.0163997. eCollection 2016.
citation: Odnoletkova I, Goderis G, Nobels F, Aertgeerts B, Annemans L, Ramaekers D. Nurse-led telecoaching of people with type 2 diabetes in primary care: rationale, design and baseline data of a randomized controlled trial. BMC Fam Pract. 2014 Feb 4;15:24. doi: 10.1186/1471-2296-15-24.
Clinical trial NCT06209320: A Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase III Clinical Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops in Slowing the Progression of Myopia in Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Myopia
Lead sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-17
Enrollment: 777
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, double-blind, placebo-controlled, multicenter, phase III clinical study of the efficacy and safety of two low-concentration atropine sulfate eye drops in slowing the progression of myopia in children

Detailed description: Primary objective is to evaluate the efficacy and safety of atropine sulfate eye drops versus placebo for 12 months in slowing the progression of myopia in children.

The study was designed to enroll approximately 777 subjects. Eligible subjects were randomly assigned to the placebo control group, Lower dose atropine group and Lower dose atropine group. Subjects received the study medication in both eyes, 1 drop each time, once every night at bedtime.

Statistical analyses were performed with the use of SAS software, version 9.4, without any specific description. All statistical tests were two-sided at a 0.05 level.

Eligibility criteria: Inclusion Criteria:

1. Child (female or male) aged 6 to 12 years.
2. Myopia (SER of at least -0.50 D and no more myopic than -6.00 D) in each eye as measuredby cycloplegic autorefraction.
3. If present, astigmatism of ≤1.50 D in each eye as measured by cycloplegic autorefraction.
4. Anisometropia SER of \< 1.50 D as measured by cycloplegic autorefraction.

Exclusion Criteria:

1. Have used other myopia control methods other than those used in this study, such as instruments (orthokeratology lenses, multifocal glasses, progressive glasses), drugs (atropine, etc.); Only single vision glasses are allowed for myopia correction;
2. Have used myopic control methods such as traditional Chinese medicine, auricular acupuncture, massage, and reverse beat within 30 days before screening;
3. Use of any local or systemic antimuscarinic/anticholinergic medication (e.g., atropine, scopolamine, tropicamide, phenamine, diphenhydramine, oxytropine, tricyclic antidepressant, etc.) within 21 days before screening; Allowing for tests such as cycloplegic optometry;

Primary outcomes:
measure: Cycloplegic Autorefraction(SER)
timeFrame: 24 months
Secondary outcomes:
measure: Axial Length
timeFrame: 24 months
Other outcomes:
measure: Relationship between age and slow myopia progression
timeFrame: 24 months
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tongren Hospital
name: Ningli Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05799820: QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC
Official title: An Open-label, Multicenter Phase II Study of QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Colorectal Carcinoma
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-05
Enrollment: 60
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: TREATMENT

Brief summary: This is an open-label, muticenter phase II study to evaluate the efficacy and safety of QL1706 monotherapy or in combination with bevacizumab and XELOX as first-line treatment of unresectable advanced or metastatic CRC.


Eligibility criteria: Inclusion Criteria:

* 1. Subjects participate voluntarily and sign informed consent.
* 2. Age ≥ 18 and ≤ 80 years old, male or female.
* 3. Histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the colon or rectum.
* 4. At least 1 measurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).

Exclusion Criteria:

* 1. Diagnosed additional maliganancy within 5 years with the expection of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,curatively resected in situ cervival or non-muscle invasive bladder cancers.
* 2. Presence of brain metastases (asymptomatic brain metastases or symptomatic brain metastases who are stable at least 4 weeks, were allowed to be enrolled).
* 3. Has active autoimmune disease that has required systemic treatment in past 2 years.
* 4. Significant cardiovascular disease.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Disease Control Rate (DCR)
timeFrame: Up to approximately 2 years
measure: Duration of Response (DOR)
timeFrame: Up to approximately 2 years
measure: Progression-free Survival (PFS)
timeFrame: Up to approximately 2 years
measure: Overall Survival (OS)
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
Study officials:
affiliation: Shanghai East Hospital
name: Jin Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04428320: The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery
Official title: The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Floor Prolapse
Surgery
Pain, Postoperative
Lead sponsor: The Cooper Health System
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: TREATMENT

Brief summary: Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP) under general anesthesia will be randomized to receive bilateral trans-vaginal pelvic floor muscle injections with bupivacaine or no injection (standard of care) as a part of their surgical pain control

Detailed description: Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP) under general anesthesia will be randomized to receive:

1. Bilateral trans- vaginal pelvic floor levator ani muscle injections (trigger point injections) with bupivacaine:

   - 0.5% bupivacaine will be injected at several sites for a total of 5ml on each side of the pelvic floor, with each injection site no more than 1 ml (Bupivacaine was chosen by the study team because of it has a longer half life then other common local anesthetics. We plan to use the same anesthetic and dosage to standardize the protocol between patients. Other local anesthetics will not be used in addition to the bupivacaine administered for research purposes. We will limit the amount of intravenous lidocaine to less than 5mg/ kg).
2. Control- No additional treatment (standard of care).

The patient will be blinded to their randomization (single blind). The post-operative pain regimen will be standardized when possible. Patients will receive a regimen of IV and oral narcotics and Ketorolac per our routine post-operative protocol. On discharge from the hospital, patients will be given prescriptions for a standard amount of oral narcotic, 20 tablets of oxycodone (150 morphine equivalents), and 30 tablets of 600mg ibuprofen.

Eligibility criteria: Inclusion Criteria:

* Female
* Able to read English and give informed consent
* Undergoing VAGINAL pelvic reconstructive surgery for POP

Exclusion Criteria:

* Hypersensitivity or allergy to amide anesthetics
* Documented chronic pain condition

  o (back pain, pelvic pain, fibromyalgia, etc.)
* Bleeding disorder
* Connective tissue disorder
* Neuromuscular disorder
* Cardiac conduction abnormality or channelopathy
* Hepatic Impairment
* Renal Impairment
* History of, or current, narcotic or alcohol dependence
* History of pelvic radiation or gynecologic malignancy

Primary outcomes:
measure: VAS analog scale on post-op day #1
timeFrame: postop day #1
Secondary outcomes:
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper Health University
state: New Jersey
Study officials:
References: